Science.gov

Sample records for fully implantable stimulator

  1. A fully implantable rodent neural stimulator

    NASA Astrophysics Data System (ADS)

    Perry, D. W. J.; Grayden, D. B.; Shepherd, R. K.; Fallon, J. B.

    2012-02-01

    The ability to electrically stimulate neural and other excitable tissues in behaving experimental animals is invaluable for both the development of neural prostheses and basic neurological research. We developed a fully implantable neural stimulator that is able to deliver two channels of intra-cochlear electrical stimulation in the rat. It is powered via a novel omni-directional inductive link and includes an on-board microcontroller with integrated radio link, programmable current sources and switching circuitry to generate charge-balanced biphasic stimulation. We tested the implant in vivo and were able to elicit both neural and behavioural responses. The implants continued to function for up to five months in vivo. While targeted to cochlear stimulation, with appropriate electrode arrays the stimulator is well suited to stimulating other neurons within the peripheral or central nervous systems. Moreover, it includes significant on-board data acquisition and processing capabilities, which could potentially make it a useful platform for telemetry applications, where there is a need to chronically monitor physiological variables in unrestrained animals.

  2. A fully implantable stimulator for use in small laboratory animals

    PubMed Central

    Millard, Rodney E.; Shepherd, Robert K.

    2007-01-01

    This paper describes a low cost, fully implantable, single channel stimulator that can be manufactured in a research laboratory. The stimulator generates charge-balanced biphasic current pulses which are delivered to a bipolar electrode array for chronic stimulation of neural tissue in free-running laboratory animals such as rats and mice. The system is magnetically coupled and contains no batteries or external leadwires. The subject is placed in a chamber surrounded by three orthogonal coils of wire which are driven to generate a magnetic field. Currents are induced in wire coils in the implanted stimulator then regulated to produce biphasic current pulses with fixed amplitude of up to 500 μA. Phase duration is adjustable from 25 – 250 μs per phase. Charge balance is maintained by capacitive coupling and shorting of the electrodes between pulses. Stimulus rate can be continuously varied, and the temporal precision of the stimulus means that the stimulator can be used in behavioural experiments or for generating electrically-evoked potentials. We describe the application of this stimulator for chronic electrical stimulation of the auditory nerve (i.e. a cochlear implant); however it will have application in other areas of neuroscience requiring controlled safe electrical stimulation of neural tissue over extended periods. Circuit diagrams and manufacturing details are provided as supplementary data. PMID:17897719

  3. A Fully-Implantable Cochlear Implant SoC with Piezoelectric Middle-Ear Sensor and Arbitrary Waveform Neural Stimulation.

    PubMed

    Yip, Marcus; Jin, Rui; Nakajima, Hideko Heidi; Stankovic, Konstantina M; Chandrakasan, Anantha P

    2015-01-01

    A system-on-chip for an invisible, fully-implantable cochlear implant is presented. Implantable acoustic sensing is achieved by interfacing the SoC to a piezoelectric sensor that detects the sound-induced motion of the middle ear. Measurements from human cadaveric ears demonstrate that the sensor can detect sounds between 40 and 90 dB SPL over the speech bandwidth. A highly-reconfigurable digital sound processor enables system power scalability by reconfiguring the number of channels, and provides programmable features to enable a patient-specific fit. A mixed-signal arbitrary waveform neural stimulator enables energy-optimal stimulation pulses to be delivered to the auditory nerve. The energy-optimal waveform is validated with in-vivo measurements from four human subjects which show a 15% to 35% energy saving over the conventional rectangular waveform. Prototyped in a 0.18 μm high-voltage CMOS technology, the SoC in 8-channel mode consumes 572 μW of power including stimulation. The SoC integrates implantable acoustic sensing, sound processing, and neural stimulation on one chip to minimize the implant size, and proof-of-concept is demonstrated with measurements from a human cadaver ear.

  4. A Fully-Implantable Cochlear Implant SoC with Piezoelectric Middle-Ear Sensor and Arbitrary Waveform Neural Stimulation

    PubMed Central

    Yip, Marcus; Jin, Rui; Nakajima, Hideko Heidi; Stankovic, Konstantina M.; Chandrakasan, Anantha P.

    2015-01-01

    A system-on-chip for an invisible, fully-implantable cochlear implant is presented. Implantable acoustic sensing is achieved by interfacing the SoC to a piezoelectric sensor that detects the sound-induced motion of the middle ear. Measurements from human cadaveric ears demonstrate that the sensor can detect sounds between 40 and 90 dB SPL over the speech bandwidth. A highly-reconfigurable digital sound processor enables system power scalability by reconfiguring the number of channels, and provides programmable features to enable a patient-specific fit. A mixed-signal arbitrary waveform neural stimulator enables energy-optimal stimulation pulses to be delivered to the auditory nerve. The energy-optimal waveform is validated with in-vivo measurements from four human subjects which show a 15% to 35% energy saving over the conventional rectangular waveform. Prototyped in a 0.18 μm high-voltage CMOS technology, the SoC in 8-channel mode consumes 572 μW of power including stimulation. The SoC integrates implantable acoustic sensing, sound processing, and neural stimulation on one chip to minimize the implant size, and proof-of-concept is demonstrated with measurements from a human cadaver ear. PMID:26251552

  5. A Fully Implantable Stimulator With Wireless Power and Data Transmission for Experimental Investigation of Epidural Spinal Cord Stimulation.

    PubMed

    Xu, Qi; Hu, Dingyin; Duan, Bingyu; He, Jiping

    2015-07-01

    Epidural spinal cord stimulation (ESCS) combined with partial weight-bearing therapy (PWBT) has been shown to facilitate recovery of functional walking for individuals after spinal cord injury (SCI). The investigation of neural mechanisms of recovery from SCI under this treatment has been conducted broadly in rodent models, yet a suitable ESCS system is still unavailable. This paper describes a practical, programmable, and fully implantable stimulator for laboratory research on rats to explore fundamental neurophysiological principles for functional recovery after SCI. The ESCS system is composed of a personal digital assistant (PDA), an external controller, an implantable pulse generator (IPG), lead extension, and stimulating electrodes. The stimulation parameters can be programmed and adjusted through a graphical user interface on the PDA. The external controller is placed on the rat back and communicates with the PDA via radio-frequency (RF) telemetry. An RF carrier from the class-E power amplifier in the external controller provides both data and power for the IPG through an inductive link. The IPG is built around a microcontroller unit to generate voltage-regulated pulses delivered to the bipolar electrode for ESCS in rats. The encapsulated IPG measures 22 mm × 23 mm × 7 mm with a mass of  ∼  3.78 g. This fully implantable batteryless stimulator provided a simplified and efficient method to carry out chronic experiments in untethered animals for medical electro-neurological research.

  6. A fully implantable stimulator with wireless power and data transmission for experimental use in epidural spinal cord stimulation.

    PubMed

    Xu, Qi; Li, Jun; Han, Wenjuan; Zhou, Houlun

    2011-01-01

    Epidural spinal cord stimulation (ESCS) combined with partial weight bearing therapy (PWBT) has been reported to facilitate recovery of functional walking for individuals after chronic incomplete spinal cord injury. This paper describes a low cost, fully implantable, advanced ESCS stimulator that can be manufactured in a research laboratory for use in small animals. The system is composed of four main parts: an external personal digital assistant (PDA), an external controller, an implantable pulse generator (IPG), lead extension and electrode. The PDA allows the experimenter to program the stimulation parameters through a user-friendly graphical interface. The external controller placed on the rat back communicates with PDA via RF telemetry. The IPG generates the biphasic charge-balanced voltage-regulated pulses, which are delivered to the bipolar electrode by the lead extension to achieve chronic ESCS in freely moving rats. A RF carrier from the Class-E amplifier in the external controller provides both data and power for the implanted circuitry through a closely coupled inductive link. The IPG is hermetically packaged using a silicon elastomer and measures 22 mm × 23 mm × 7 mm with a mass of ~3.78 g.

  7. [Fully implantable hearing systems].

    PubMed

    Maurer, J

    2009-03-01

    As yet comparatively little experience has been gained with fully implantable hearing systems, as the two systems available at present have only recently received CE permission for Europe and the FDA permissions are still pending in the USA. Additionally the technology is expensive and usually not covered by insurance companies. However, it could be shown that by careful patient selection and very careful surgical techniques, good results can be achieved with this highly sensitive technology, often with better patient satisfaction and hearing quality than with conventional hearing aids. To spread the technology further, the systems must also show reliable results on a broad application. Further surgery to change the batteries should not be necessary more frequently than with cardiac pacemakers. Not all technical problems are finally solved. However, it is to be foreseen that fully implantable hearing systems will be a good long-term alternative to conventional hearing aids for some patients.

  8. Fully Implantable Deep Brain Stimulation System with Wireless Power Transmission for Long-term Use in Rodent Models of Parkinson's Disease

    PubMed Central

    Heo, Man Seung; Moon, Hyun Seok; Kim, Hee Chan; Park, Hyung Woo; Lim, Young Hoon

    2015-01-01

    Objective The purpose of this study to develop new deep-brain stimulation system for long-term use in animals, in order to develop a variety of neural prostheses. Methods Our system has two distinguished features, which are the fully implanted system having wearable wireless power transfer and ability to change the parameter of stimulus parameter. It is useful for obtaining a variety of data from a long-term experiment. Results To validate our system, we performed pre-clinical test in Parkinson's disease-rat models for 4 weeks. Through the in vivo test, we observed the possibility of not only long-term implantation and stability, but also free movement of animals. We confirmed that the electrical stimulation neither caused any side effect nor damaged the electrodes. Conclusion We proved possibility of our system to conduct the long-term pre-clinical test in variety of parameter, which is available for development of neural prostheses. PMID:25810853

  9. Fully Implantable Deep Brain Stimulation System with Wireless Power Transmission for Long-term Use in Rodent Models of Parkinson's Disease.

    PubMed

    Heo, Man Seung; Moon, Hyun Seok; Kim, Hee Chan; Park, Hyung Woo; Lim, Young Hoon; Paek, Sun Ha

    2015-03-01

    The purpose of this study to develop new deep-brain stimulation system for long-term use in animals, in order to develop a variety of neural prostheses. Our system has two distinguished features, which are the fully implanted system having wearable wireless power transfer and ability to change the parameter of stimulus parameter. It is useful for obtaining a variety of data from a long-term experiment. To validate our system, we performed pre-clinical test in Parkinson's disease-rat models for 4 weeks. Through the in vivo test, we observed the possibility of not only long-term implantation and stability, but also free movement of animals. We confirmed that the electrical stimulation neither caused any side effect nor damaged the electrodes. We proved possibility of our system to conduct the long-term pre-clinical test in variety of parameter, which is available for development of neural prostheses.

  10. A Fully Implantable 96-channel Neural Data Acquisition System

    PubMed Central

    Rizk, Michael; Bossetti, Chad A; Jochum, Thomas A; Callender, Stephen H; Nicolelis, Miguel A L; Turner, Dennis A; Wolf, Patrick D

    2009-01-01

    A fully implantable neural data acquisition system is a key component of a clinically viable brain-machine interface. This type of system must communicate with the outside world and obtain power without the use of wires that cross through the skin. We present a 96-channel fully implantable neural data acquisition system. This system performs spike detection and extraction within the body and wirelessly transmits data to an external unit. Power is supplied wirelessly through the use of inductively-coupled coils. The system was implanted acutely in sheep and successfully recorded, processed, and transmitted neural data. Bidirectional communication between the implanted system and an external unit was successful over a range of 2 m. The system is also shown to integrate well into a brain-machine interface. This demonstration of a high channel-count fully implanted neural data acquisition system is a critical step in the development of a clinically viable brain-machine interface. PMID:19255459

  11. A fully implantable 96-channel neural data acquisition system

    NASA Astrophysics Data System (ADS)

    Rizk, Michael; Bossetti, Chad A.; Jochum, Thomas A.; Callender, Stephen H.; Nicolelis, Miguel A. L.; Turner, Dennis A.; Wolf, Patrick D.

    2009-04-01

    A fully implantable neural data acquisition system is a key component of a clinically viable brain-machine interface. This type of system must communicate with the outside world and obtain power without the use of wires that cross through the skin. We present a 96-channel fully implantable neural data acquisition system. This system performs spike detection and extraction within the body and wirelessly transmits data to an external unit. Power is supplied wirelessly through the use of inductively coupled coils. The system was implanted acutely in sheep and successfully recorded, processed and transmitted neural data. Bidirectional communication between the implanted system and an external unit was successful over a range of 2 m. The system is also shown to integrate well into a brain-machine interface. This demonstration of a high channel-count fully implanted neural data acquisition system is a critical step in the development of a clinically viable brain-machine interface.

  12. A fully implantable 96-channel neural data acquisition system.

    PubMed

    Rizk, Michael; Bossetti, Chad A; Jochum, Thomas A; Callender, Stephen H; Nicolelis, Miguel A L; Turner, Dennis A; Wolf, Patrick D

    2009-04-01

    A fully implantable neural data acquisition system is a key component of a clinically viable brain-machine interface. This type of system must communicate with the outside world and obtain power without the use of wires that cross through the skin. We present a 96-channel fully implantable neural data acquisition system. This system performs spike detection and extraction within the body and wirelessly transmits data to an external unit. Power is supplied wirelessly through the use of inductively coupled coils. The system was implanted acutely in sheep and successfully recorded, processed and transmitted neural data. Bidirectional communication between the implanted system and an external unit was successful over a range of 2 m. The system is also shown to integrate well into a brain-machine interface. This demonstration of a high channel-count fully implanted neural data acquisition system is a critical step in the development of a clinically viable brain-machine interface.

  13. Polymeric Packaging for Fully Implantable Wireless Neural Microsensors

    PubMed Central

    Aceros, Juan; Yin, Ming; Borton, David A.; Patterson, William R.; Bull, Christopher; Nurmikko, Arto V.

    2014-01-01

    We present polymeric packaging methods used for subcutaneous, fully implantable, broadband, and wireless neurosensors. A new tool for accelerated testing and characterization of biocompatible polymeric packaging materials and processes is described along with specialized test units to simulate our fully implantable neurosensor components, materials and fabrication processes. A brief description of the implantable systems is presented along with their current encapsulation methods based on polydimethylsiloxane (PDMS). Results from in-vivo testing of multiple implanted neurosensors in swine and non-human primates are presented. Finally, a novel augmenting polymer thin film material to complement the currently employed PDMS is introduced. This thin layer coating material is based on the Plasma Enhanced Chemical Vapor Deposition (PECVD) process of Hexamethyldisiloxane (HMDSO) and Oxygen (O2). PMID:23365999

  14. Polymeric packaging for fully implantable wireless neural microsensors.

    PubMed

    Aceros, Juan; Yin, Ming; Borton, David A; Patterson, William R; Bull, Christopher; Nurmikko, Arto V

    2012-01-01

    We present polymeric packaging methods used for subcutaneous, fully implantable, broadband, and wireless neurosensors. A new tool for accelerated testing and characterization of biocompatible polymeric packaging materials and processes is described along with specialized test units to simulate our fully implantable neurosensor components, materials and fabrication processes. A brief description of the implantable systems is presented along with their current encapsulation methods based on polydimethylsiloxane (PDMS). Results from in-vivo testing of multiple implanted neurosensors in swine and non-human primates are presented. Finally, a novel augmenting polymer thin film material to complement the currently employed PDMS is introduced. This thin layer coating material is based on the Plasma Enhanced Chemical Vapor Deposition (PECVD) process of Hexamethyldisiloxane (HMDSO) and Oxygen (O(2)).

  15. Brain plasticity under cochlear implant stimulation.

    PubMed

    Kral, Andrej; Tillein, Jochen

    2006-01-01

    The benefit of cochlear implantation crucially depends on the ability of the brain to learn to classify neural activity evoked by the cochlear implant. Brain plasticity is a complex property with massive developmental changes after birth. The present paper reviews the experimental work on auditory plasticity and focuses on the plasticity required for adaptation to cochlear implant stimulation. It reviews the data on developmental sensitive periods in auditory plasticity of hearing, hearing-impaired and deaf, cochlear-implanted, animals. Based on the analysis of the above findings in animals and comparable data from humans, a cochlear implantation within the first 2 years of age is recommended.

  16. Fully implantable hearing aid in the incudostapedial joint gap.

    PubMed

    Koch, Martin; Eßinger, Till Moritz; Stoppe, Thomas; Lasurashvili, Nikoloz; Bornitz, Matthias; Zahnert, Thomas

    2016-10-01

    A fully implantable hearing aid is introduced which is a combined sensor-actuator-transducer designed for insertion into the incudostapedial joint gap (ISJ). The active elements each consist of a thin titanium membrane with an applied piezoelectric single crystal. The effectiveness of the operating principle is verified in a temporal bone study. We also take a closer look at the influence of an implantation-induced increase in middle ear stiffness on the transducer's output. An assembly of the transducer with 1 mm thickness is built and inserted into six temporal bones. At this thickness, the stiffness of the annular ligament is considerably increased, which leads to a loss in functional gain for the transducer. It is assumed that a thinner transducer would reduce this effect. In order to examine the performance for a prospective reduced pretension, we increased the gap size at the ISJ by 0.5 mm by removing the capitulum of the stapes in four temporal bones. The TM is stimulated with a broadband multisine sound signal in the audiological frequency range. The movement of the stapes footplate is measured with a laser Doppler vibrometer. The sensor signal is digitally processed and the amplified signal drives the actuator. The resulting feedback is minimized by an active noise control least mean square (LMS) algorithm which is implemented on a field programmable gate array. The dynamic range and the functional gain of the transducer in the temporal bones are determined. The results are compared to measurements from temporal bones without ISJ extension and to the results of Finite Elements Model (FE model) simulations. In the frequency range above 2 kHz a functional gain of 30 dB and more is achieved. This proposes the transducer as a potential treatment for high frequency hearing loss, e.g. for patients with noise-induced hearing loss. The transducer offers sufficient results for a comprehensive application. Adaptations in the transducer design or surgical

  17. Considering optogenetic stimulation for cochlear implants.

    PubMed

    Jeschke, Marcus; Moser, Tobias

    2015-04-01

    Electrical cochlear implants are by far the most successful neuroprostheses and have been implanted in over 300,000 people worldwide. Cochlear implants enable open speech comprehension in most patients but are limited in providing music appreciation and speech understanding in noisy environments. This is generally considered to be due to low frequency resolution as a consequence of wide current spread from stimulation contacts. Accordingly, the number of independently usable stimulation channels is limited to less than a dozen. As light can be conveniently focused, optical stimulation might provide an alternative approach to cochlear implants with increased number of independent stimulation channels. Here, we focus on summarizing recent work on optogenetic stimulation as one way to develop optical cochlear implants. We conclude that proof of principle has been presented for optogenetic stimulation of the cochlea and central auditory neurons in rodents as well as for the technical realization of flexible μLED-based multichannel cochlear implants. Still, much remains to be done in order to advance the technique for auditory research and even more for eventual clinical translation. This article is part of a Special Issue entitled .

  18. A Fully Implantable, NFC Enabled, Continuous Interstitial Glucose Monitor.

    PubMed

    Anabtawi, Nijad; Freeman, Sabrina; Ferzli, Rony

    2016-02-01

    This work presents an integrated system-on-chip (SoC) that forms the core of a long-term, fully implantable, battery assisted, passive continuous glucose monitor. It integrates an amperometric glucose sensor interface, a near field communication (NFC) wireless front-end and a fully digital switched mode power management unit for supply regulation and on board battery charging. It uses 13.56 MHz (ISM) band to harvest energy and backscatter data to an NFC reader. System was implemented in 14nm CMOS technology and validated with post layout simulations.

  19. Wirelessly powering miniature implants for optogenetic stimulation

    NASA Astrophysics Data System (ADS)

    Yeh, Alexander J.; Ho, John S.; Tanabe, Yuji; Neofytou, Evgenios; Beygui, Ramin E.; Poon, Ada S. Y.

    2013-10-01

    Conventional methods for in vivo optogenetic stimulation require optical fibers or mounted prosthesis. We present an approach for wirelessly powering implantable stimulators using electromagnetic midfield. By exploiting the properties of the midfield, we demonstrate the ability to generate high intensity light pulses in a freely moving animal.

  20. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted cerebellar stimulator. 882.5820 Section... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820 Implanted cerebellar stimulator. (a) Identification. An implanted cerebellar stimulator is a device used to stimulate...

  1. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted cerebellar stimulator. 882.5820 Section... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820 Implanted cerebellar stimulator. (a) Identification. An implanted cerebellar stimulator is a device used to stimulate...

  2. Implantable microcoils for intracortical magnetic stimulation

    PubMed Central

    Lee, Seung Woo; Fallegger, Florian; Casse, Bernard D. F.; Fried, Shelley I.

    2016-01-01

    Neural prostheses that stimulate the neocortex have the potential to treat a wide range of neurological disorders. However, the efficacy of electrode-based implants remains limited, with persistent challenges that include an inability to create precise patterns of neural activity as well as difficulties in maintaining response consistency over time. These problems arise from fundamental limitations of electrodes as well as their susceptibility to implantation and have proven difficult to overcome. Magnetic stimulation can address many of these limitations, but coils small enough to be implanted into the cortex were not thought strong enough to activate neurons. We describe a new microcoil design and demonstrate its effectiveness for both activating cortical neurons and driving behavioral responses. The stimulation of cortical pyramidal neurons in brain slices in vitro was reliable and could be confined to spatially narrow regions (<60 μm). The spatially asymmetric fields arising from the coil helped to avoid the simultaneous activation of passing axons. In vivo implantation was safe and resulted in consistent and predictable behavioral responses. The high permeability of magnetic fields to biological substances may yield another important advantage because it suggests that encapsulation and other adverse effects of implantation will not diminish coil performance over time, as happens to electrodes. These findings suggest that a coil-based implant might be a useful alternative to existing electrode-based devices. The enhanced selectivity of microcoil-based magnetic stimulation will be especially useful for visual prostheses as well as for many brain-computer interface applications that require precise activation of the cortex. PMID:27957537

  3. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted neuromuscular stimulator. 882.5860... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5860 Implanted neuromuscular stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that provides...

  4. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted neuromuscular stimulator. 882.5860... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5860 Implanted neuromuscular stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that provides...

  5. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted neuromuscular stimulator. 882.5860... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5860 Implanted neuromuscular stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that provides...

  6. Useful applications and limits of battery powered implants in functional electrical stimulations.

    PubMed

    Lanmüller, H; Bijak, M; Mayr, W; Rafolt, D; Sauermann, S; Thoma, H

    1997-03-01

    Battery powered stimulation implants have been well-known for a long time as heart pacemakers. In the last few years, fully implantable stimulators have been used in the field of functional electrical stimulation (FES) for applications like dynamic cardiomyoplasty and electro-stimulated graciloplasty for fecal incontinence. The error rate of battery powered implants is significantly smaller than that for conventional stimulator systems, and the quality of life for the patients is increased because the need for an external power and control unit is eliminated. The use of battery powered implants is limited by the complexity of the stimulation control strategies and the battery capacity. Therefore, applications like the stimulation of lower extremities for walking, cochlea stimulation, or direct muscle stimulation cannot be supported. The improvement of implantable batteries, microcontrollers, and ultralow power products is ongoing. In the future, battery powered implants will also meet the requirements of complex applications. Systems for restoration of hand and breathing functions after spinal cord injury can be the next field of use for battery powered implants. For these purposes, we developed a battery powered multichannel implant with a sufficient life span for phrenic pacing. The problems during development and the limits of this system are described in this paper.

  7. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... neuromuscular stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted neuromuscular stimulator....

  8. Soft, stretchable, fully implantable miniaturized optoelectronic systems for wireless optogenetics

    PubMed Central

    Park, Sung Il; Brenner, Daniel S.; Shin, Gunchul; Morgan, Clinton D.; Copits, Bryan A.; Chung, Ha Uk; Pullen, Melanie Y.; Noh, Kyung Nim; Davidson, Steve; Oh, Soong Ju; Yoon, Jangyeol; Jang, Kyung-In; Samineni, Vijay K.; Norman, Megan; Grajales-Reyes, Jose G.; Vogt, Sherri K; Sundaram, Saranya S.; Wilson, Kellie M.; Ha, Jeong Sook; Xu, Renxiao; Pan, Taisong; Kim, Tae-il; Huang, Yonggang; Montana, Michael C.; Golden, Judith P.; Bruchas, Michael R.; Gereau, Robert W.; Rogers, John A.

    2016-01-01

    Optogenetics allows rapid, temporally specific control of neuronal activity via targeted expression and activation of light-sensitive proteins. Implementation typically requires remote light sources and fiber-optic delivery schemes that impose significant physical constraints on natural behaviors. In this report we bypass these limitations using novel technologies that combine thin, mechanically soft neural interfaces with fully implantable, stretchable wireless radio power and control systems. The resulting devices achieve optogenetic modulation of the spinal cord and peripheral nervous system. This is demonstrated with two form factors; stretchable film appliques that interface directly with peripheral nerves, and flexible filaments that insert into the narrow confines of the spinal epidural space. These soft, thin devices are minimally invasive, and histological tests suggest they can be used in chronic studies. We demonstrate the power of this technology by modulating peripheral and spinal pain circuitry, providing evidence for the potential widespread use of these devices in research and future clinical applications of optogenetics outside the brain. PMID:26551059

  9. Optimization of kinetic energy harvesters design for fully implantable Cochlear Implants.

    PubMed

    Sudano, A; Accoto, D; Francomano, M T; Salvinelli, F; Guglielmelli, E

    2011-01-01

    Fully implantable Cochlear Implants (CIs) would represent a tremendous advancement in terms of quality of life, comfort and cosmetics, for patients with profound sensorineural deafness. One of the main challenges involved in the development of such implants consists of finding a power supply means which does not require recharging. To this aim an inertial Energy Harvester (EH), exploiting the kinetic energy produced by vertical movements of the head during walking, has been investigated. Compared to existing devices, the EH needs to exploit very low frequency vibrations (<2.5 Hz) with small amplitude (<9 m/s(2)). In order to maximize the power transduced, an optimization method has been developed, which is the objective of this paper. The method consists in calculating the dynamical behavior of the EH using discrete transforms of experimentally measured acceleration profiles. It is shown that the quick integration of the second order dynamical equation allows the use of computationally intensive optimization techniques, such as Genetic Algorithms (GAs). The robustness of the solution is also evaluated.

  10. Design and operation of a fully implantable SMA actuated implant for correcting short bowel syndrome

    NASA Astrophysics Data System (ADS)

    Utter, Brent; Luntz, Jonathan; Brei, Diann; Teitelbaum, Daniel; Okawada, Manabu; Miyasaka, Eiichi

    2009-03-01

    Short Bowel Syndrome (SBS) is medical condition characterized by insufficient small intestine length, leading to improper nutrient absorption and significant mortality rates. The complications of current treatment methods have encouraged the development of a novel treatment method based on mechanotransduction, the process through which mechanical tensile loading induces longitudinal growth of intestine. Animal based studies with simple extension devices have demonstrated the potential of the treatment to grow healthy bowel, but an implantable device suitable for clinical use remains undeveloped. This paper presents the development of an instrumented fully implantable bowel extender based upon a shape memory alloy driven linear ratchet that can be controlled and monitored remotely. The overall bowel extender system is described with respect to specifications for pig experimental tests. The functionality of the mechanical and electrical subsystems of the device are detailed and experimentally validated on the bench top, in segments of living bowel tissue removed from a pig, and in cadaveric pigs. Mechanical loading characteristics and safe load limits on bowel tissue are identified. Results from these experiments establish the readiness of the device to be tested in living pigs, enabling studies to move one step closer to clinical studies.

  11. Implantation of anterior sacral root stimulators combined with posterior sacral rhizotomy in spinal injury patients.

    PubMed

    Egon, G; Barat, M; Colombel, P; Visentin, C; Isambert, J L; Guerin, J

    1998-01-01

    Brindley-Finetech sacral anterior root stimulators combined with posterior sacral rhizotomy were implanted in 68 males and 28 females with spinal cord lesions. In 9 patients the electrodes were implanted extradurally in the sacrum, and in 90 patients they were implanted intradurally (3 patients had a second extradural implant after a first intradural implant). Three patients died from causes unrelated to the implant. Of the 93 surviving patients, 83 used their implants for micturition and 82 were fully continent. The mean bladder capacity increased from 206 ml preoperatively to 564 ml after the operation. Three patients had a preoperative vesicorenal reflux that disappeared after surgery. In all, 51 patients used the stimulator for defecation. Erection was possible with electrical stimulation in 46 males and was used for coitus by 17 couples. Secondary deafferentation at the level of the conus was performed four times. Three patients who had a cerebrospinal fluid leak were operated on again. Two implants had to be removed because of infection. Sacral anterior root stimulation combined with sacral deafferentation is a welcome addition to the treatment of neurogenic bladder in spinal cord injury patients.

  12. Subdural hematoma following spinal cord stimulator implant.

    PubMed

    Chiravuri, Srinivas; Wasserman, Ronald; Chawla, Amit; Haider, Naeem

    2008-01-01

    Headache following interventional procedures is a diagnostic challenge due to the multitude of possible etiologies involved. Presentation can be simple (PDPH alone) or complex (exacerbation of pre-existing chronic headache along with PDPH) or headache associated with a new onset intracranial process. Subdural hematoma is a rare complication of cranio-spinal trauma. Cranial subdural hematoma may present in an acute, sub-acute, or chronic fashion. Diagnosis of a subdural hematoma in the wake of a PDPH is difficult, requiring a high level of suspicion. Delayed diagnosis of subdural hematoma is usually related to failure to consider it in the differential diagnosis. Thorough history, assessment of the evolution of symptoms, and imaging studies may identify the possible cause and help direct treatment. Change in the character of initial presenting symptoms may be a sign of resolution of the headache or the onset of a secondary process. We report a case of acute intracranial subdural hematoma secondary to unintentional dural puncture during placement of a permanent spinal cord stimulator lead for refractory angina. There is need for careful follow-up of patients with a known post-dural tear. Failure to identify uncommon adverse events in patients with complicated spinal cord stimulator implantation may lead to permanent injury.

  13. MRI interactions of a fully implantable pressure monitoring device.

    PubMed

    Stehlin, Ellyce F; McCormick, Daniel; Malpas, Simon C; Pontré, Beau P; Heppner, Peter A; Budgett, David M

    2015-11-01

    To investigate the potential patient risk and interactions between a prototype implantable pressure monitoring device and a 3T clinical magnetic resonance imaging (MRI) machine to guide device design towards MR Conditional safety approval. The pressure monitor device contained a catheter-mounted piezo-resistive pressure sensor, rechargeable battery, wireless communication system, and inductive pickup coil. Standard testing methods were used to guide experiments to investigate static field induced force and torque, radiofrequency (RF)-induced heating, image artifacts, and the MR's effect on device function. The specific clinical application of intracranial pressure monitoring was considered. RF-induced heating experiments were supported by numerical modeling of the RF body coil, the device, and experimental phantom. Sensing catheter lead length and configuration was an important component of the device design. A short 150 mm length catheter produced a heating effect of less than 2°C and a long 420 mm length catheter caused heating of 7.2°C. Static magnetic field interactions were below standard safety risk levels and the MR did not interfere with device function; however, artifacts have the potential to interfere with image quality. Investigation of MR interactions at the prototype stage provides useful implantable device design guidance and confidence that an implantable pressure monitor may be able to achieve MR Conditional safety approval. © 2015 Wiley Periodicals, Inc.

  14. Chronic cortical and electromyographic recordings from a fully implantable device: preclinical experience in a nonhuman primate

    NASA Astrophysics Data System (ADS)

    Ryapolova-Webb, Elena; Afshar, Pedram; Stanslaski, Scott; Denison, Tim; de Hemptinne, Coralie; Bankiewicz, Krystof; Starr, Philip A.

    2014-02-01

    Objective. Analysis of intra- and perioperatively recorded cortical and basal ganglia local field potentials in human movement disorders has provided great insight into the pathophysiology of diseases such as Parkinson's, dystonia, and essential tremor. However, in order to better understand the network abnormalities and effects of chronic therapeutic stimulation in these disorders, long-term recording from a fully implantable data collection system is needed. Approach. A fully implantable investigational data collection system, the Activa® PC + S neurostimulator (Medtronic, Inc., Minneapolis, MN), has been developed for human use. Here, we tested its utility for extended intracranial recording in the motor system of a nonhuman primate. The system was attached to two quadripolar paddle arrays: one covering sensorimotor cortex, and one covering a proximal forelimb muscle, to study simultaneous cortical field potentials and electromyography during spontaneous transitions from rest to movement. Main results. Over 24 months of recording, movement-related changes in physiologically relevant frequency bands were readily detected, including beta and gamma signals at approximately 2.5 μV/\\sqrtHz and 0.7 μV/\\sqrt{Hz}, respectively. The system architecture allowed for flexible recording configurations and algorithm triggered data recording. In the course of physiological analyses, sensing artifacts were observed (˜1 μVrms stationary tones at fixed frequency), which were mitigated either with post-processing or algorithm design and did not impact the scientific conclusions. Histological examination revealed no underlying tissue damage; however, a fibrous capsule had developed around the paddles, demonstrating a potential mechanism for the observed signal amplitude reduction. Significance. This study establishes the usefulness of this system in measuring chronic brain and muscle signals. Use of this system may potentially be valuable in human trials of chronic brain

  15. Fully implantable, battery-free wireless optoelectronic devices for spinal optogenetics.

    PubMed

    Samineni, Vijay K; Yoon, Jangyeol; Crawford, Kaitlyn E; Jeong, Yu Ra; McKenzie, Kajanna C; Shin, Gunchul; Xie, Zhaoqian; Sundaram, Saranya S; Li, Yuhang; Yang, Min Young; Kim, Jeonghyun; Wu, Di; Xue, Yeguang; Feng, Xue; Huang, Yonggang; Mickle, Aaron D; Banks, Anthony; Ha, Jeong Sook; Golden, Judith P; Rogers, John A; Gereau, Robert W

    2017-06-08

    The advent of optogenetic tools has allowed unprecedented insights into the organization of neuronal networks. Although recently developed technologies have enabled implementation of optogenetics for studies of brain function in freely moving, untethered animals, wireless powering and device durability pose challenges in studies of spinal cord circuits where dynamic, multidimensional motions against hard and soft surrounding tissues can lead to device degradation. We demonstrate here a fully implantable optoelectronic device powered by near-field wireless communication technology, with a thin and flexible open architecture that provides excellent mechanical durability, robust sealing against biofluid penetration and fidelity in wireless activation, thereby allowing for long-term optical stimulation of the spinal cord without constraint on the natural behaviors of the animals. The system consists of a double-layer, rectangular-shaped magnetic coil antenna connected to a microscale inorganic light-emitting diode (μ-ILED) on a thin, flexible probe that can be implanted just above the dura of the mouse spinal cord for effective stimulation of light-sensitive proteins expressed in neurons in the dorsal horn. Wireless optogenetic activation of TRPV1-ChR2 afferents with spinal μ-ILEDs causes nocifensive behaviors and robust real-time place aversion with sustained operation in animals over periods of several weeks to months. The relatively low-cost electronics required for control of the systems, together with the biocompatibility and robust operation of these devices will allow broad application of optogenetics in future studies of spinal circuits, as well as various peripheral targets, in awake, freely moving and untethered animals, where existing approaches have limited utility.

  16. A microcontroller-based implantable nerve stimulator used for rats.

    PubMed

    Sha, Hong; Zheng, Zheng; Wang, Yan; Ren, Chaoshi

    2005-01-01

    A microcontroller-based stimulator that can be flexible programmed after it has been implanted into a rat was studied. Programmability enables implanted stimulators to generate customized, complex protocols for experiments. After implantation, a coded light pulse train that contains information of specific identification will unlock a certain stimulator. If a command that changing the parameters is received, the microcontroller will update its flash memory after it affirms the commands. The whole size of it is only 1.6 cubic centimeters, and it can work for a month. The devices have been successfully used in animal behavior experiments, especially on rats.

  17. A fully integrated microbattery for an implantable microelectromechanical system

    NASA Astrophysics Data System (ADS)

    Albano, F.; Lin, Y. S.; Blaauw, D.; Sylvester, D. M.; Wise, K. D.; Sastry, A. M.

    The Wireless Integrated Microsystems Engineering Research Center's Intraocular Sensor (WIMS-ERC IOS) was studied as a model system for an integrated, autonomous implantable device. In the present study, we had four objectives: (1) select and designing an optimized power supply for the WIMS-IOS; (2) develop a fabrication technique allowing small scale, low-cost, and integrable fabrication for CMOS systems, and experimentally demonstrate a microscopic power source; (3) map capacity and lifetime of several fabricated microbatteries; (4) determine the effects of miniaturization on capacity, lifetime and device architecture. Physical vapor deposition (PVD) was used to deposit thin layers (≤1 μm) of metal sequentially onto glass substrates (SiO 2, as used in the device). To map the influence of size over cell capacity and cycle life, we fabricated and tested five stand-alone cells using a Solartron ® 1470E battery tester and a Maccor ® 4000 series tester. A sixth battery was fabricated to investigate the effects of system integration, variable discharge rate and size reduction simultaneously. The highest experimental capacity among the larger cells O(cm 2) was 100 μAh, achieved by IOS-C-1 at 250 μA (1.4 C) discharge. Among O(mm 2) cells, IOS-M-1 achieved the highest capacity (2.75 μAh, ∼76% of theoretical) at 2.5 μA discharge (0.7 C rate).

  18. Melatonin stimulates osteointegration of dental implants.

    PubMed

    Cutando, Antonio; Gómez-Moreno, Gerardo; Arana, Carlos; Muñoz, Fernando; Lopez-Peña, Mónica; Stephenson, Jean; Reiter, Russel J

    2008-09-01

    The aim of this study was to evaluate the effect of the topical application of melatonin on osteointegration of dental implants in Beagle dogs 14 days after their insertion. In preparation for subsequent insertion of dental implants, upper and lower premolars and molars were extracted from 12 Beagle dogs. Each mandible received cylindrical screw implants of 3.25 mm in diameter and 10 mm in length. The implants were randomly assigned to the mesial and distal sites on each side of the mandible. Prior to implanting, 1.2 mg lyophylized powdered melatonin was applied to one bone hole at each side of the mandible. None was applied at the control sites. Eight histological sections per implant were obtained for histomorphometric studies. After a 2-wk treatment period, melatonin significantly increased the perimeter of bone that was in direct contact with the treated implants (P < 0.0001), bone density (P < 0.0001), new bone formation (P < 0.0001) and inter-thread bone (P < 0.05) in comparison with control implants. Topical application of melatonin may act as a biomimetic agent in the placement of endo-osseous dental implants.

  19. Development of functional electrical stimulators utilizing cochlear implant technology.

    PubMed

    Davis, R; Patrick, J; Barriskill, A

    2001-01-01

    In 1983, R. Davis proposed the development of a functional electrical stimulator, based on multi-channel cochlear implant technology, for the restoration of function in spinal cord injured paraplegic subjects. In 1984, the US Veteran Administration funded the initial investigations including animal experiments and purchase of a FES stimulator based on the Nucleus 22 cochlear implant. In 1987, the US Food and Drug Administration approved an Investigational Device Exemption (IDE# G870142) for this FES project. In 1991, the first stimulator was implanted in a 21-year old male paraplegic subject (complete thoracic spinal cord lesion at level #10), who was subsequently able to stand and to perform one-handed tasks for up to 1h. In 1996-1997 development started on a new multi-function FES system. In 1998, a stimulator was implanted in a 35-year-old male paraplegic subject (complete thoracic spinal cord lesion at level #10). After 8 months of use providing multiple functions including bladder voiding, the implant's internal antenna wire broke. A modified implant (FES 24-B) is due to be implanted in July 2001.

  20. Composite implants coated with biodegradable polymers prevent stimulating tumor progression

    NASA Astrophysics Data System (ADS)

    Litviakov, N. V.; Tverdokhlebov, S. I.; Perelmuter, V. M.; Kulbakin, D. E.; Bolbasov, E. N.; Tsyganov, M. M.; Zheravin, A. A.; Svetlichnyi, V. A.; Cherdyntseva, N. V.

    2016-08-01

    In this experiment we studied oncologic safety of model implants created using the solution blow spinning method with the use of the PURASORB PL-38 polylactic acid polymer and organic mineral filler which was obtained via laser ablation of a solid target made of dibasic calcium phosphate dihydrate. For this purpose the implant was introduced into the area of Wistar rats' iliums, and on day 17 after the surgery the Walker sarcoma was transplanted into the area of the implant. We evaluated the implant's influence on the primary tumor growth, hematogenous and lymphogenous metastasis of the Walker sarcoma. In comparison with sham operated animals the implant group demonstrated significant inhibition of hematogenous metastasis on day 34 after the surgery. The metastasis inhibition index (MII) equaled 94% and the metastases growth inhibition index (MGII) equaled 83%. The metastasis frequency of the Walker sarcoma in para aortic lymph nodes in the implant group was not statistically different from the control frequency; there was also no influence of the implant on the primary tumor growth noted. In case of the Walker sarcoma transplantation into the calf and the palmar pad of the ipsilateral limb to the one with the implant in the ilium, we could not note any attraction of tumor cells to the implant area, i.e. stimulation of the Walker sarcoma relapse by the implant. Thus, the research concluded that the studied implant meets the requirements of oncologic safety.

  1. Composite implants coated with biodegradable polymers prevent stimulating tumor progression

    SciTech Connect

    Litviakov, N. V. Tsyganov, M. M. Cherdyntseva, N. V.; Tverdokhlebov, S. I. Bolbasov, E. N.; Perelmuter, V. M. Kulbakin, D. E.; Zheravin, A. A.; Svetlichnyi, V. A.

    2016-08-02

    In this experiment we studied oncologic safety of model implants created using the solution blow spinning method with the use of the PURASORB PL-38 polylactic acid polymer and organic mineral filler which was obtained via laser ablation of a solid target made of dibasic calcium phosphate dihydrate. For this purpose the implant was introduced into the area of Wistar rats’ iliums, and on day 17 after the surgery the Walker sarcoma was transplanted into the area of the implant. We evaluated the implant’s influence on the primary tumor growth, hematogenous and lymphogenous metastasis of the Walker sarcoma. In comparison with sham operated animals the implant group demonstrated significant inhibition of hematogenous metastasis on day 34 after the surgery. The metastasis inhibition index (MII) equaled 94% and the metastases growth inhibition index (MGII) equaled 83%. The metastasis frequency of the Walker sarcoma in para aortic lymph nodes in the implant group was not statistically different from the control frequency; there was also no influence of the implant on the primary tumor growth noted. In case of the Walker sarcoma transplantation into the calf and the palmar pad of the ipsilateral limb to the one with the implant in the ilium, we could not note any attraction of tumor cells to the implant area, i.e. stimulation of the Walker sarcoma relapse by the implant. Thus, the research concluded that the studied implant meets the requirements of oncologic safety.

  2. SaBer DBS: a fully programmable, rechargeable, bilateral, charge-balanced preclinical microstimulator for long-term neural stimulation

    PubMed Central

    Ewing, Samuel G.; Porr, Bernd; Riddell, John; Winter, Christine; Grace, Anthony A.

    2013-01-01

    To effectively study the mechanisms by which deep brain stimulation (DBS) produces its therapeutic benefit and to evaluate new therapeutic indications, it is vital to administer DBS over an extended period of time in awake, freely behaving animals. To date multiple preclinical stimulators have been designed and described. However, these stimulators have failed to incorporate some of the design criteria necessary to provide a system analogous to those used clinically. Here we define these design criteria and propose an improved and complete preclinical DBS system. This system is fully programmable in frequency, pulse-width and current amplitude, has a rechargeable battery and delivers biphasic, charge-balanced output to two independent electrodes. The system has been optimized for either implantation or for use externally via attachment to rodent jackets. PMID:23305773

  3. Masseteric post-stimulus EMG complex following mechanical stimulation of osseointegrated oral implants.

    PubMed

    Bonte, B; van Steenberghe, D

    1991-05-01

    Periodontal receptors can be located in the periodontal ligament itself, the alveolar bone, the periosteum and the gingiva. The aim of the present study was to quantify the contribution of the periodontal ligament receptors in eliciting a reflex response in human masseter muscles. Surface EMG recordings were made in 17 human subjects, fully or partially edentulous, and all provided with osseointegrated oral implants ad modum Brånemark. They maintained a constant clenching level. Mechanical stimulation of an oral implant in the upper central incisor region failed to elicit a reflex in fully edentulous subjects with oral implants in both jaws. The absence of a reflex response strongly suggests that the receptors in the periodontal ligament itself are mainly responsible for the reflex. Stimulation of the same area in subjects with oral implants in the upper jaw and natural teeth in the lower jaw elicited a reflex response in most subjects. Since they were instructed to clench in full habitual occlusion, transmission from the stimulated area to periodontal receptors of natural teeth is very probable.

  4. Technical tips during implantation of selective upper airway stimulation.

    PubMed

    Heiser, Clemens; Thaler, Erica; Soose, Ryan J; Woodson, B Tucker; Boon, Maurits

    2017-07-06

    Selective upper airway stimulation is now well-established in the United States and in several European countries, with more than 1,000 patients implanted since U.S. Food and Drug Administration approval in April 2014. The authors herein, all head and neck surgeons, account for approximately one of every five implants completed to date. Several of the authors also provide comprehensive longitudinal care of their patients as dual-specialty sleep medicine physicians. Multi-center, retrospective clinical analysis. More than 300 implants have been evaluated and reviewed in five different implant centers (Germany, United States). This analysis shares tips and techniques from the collective experiences with more than 300 implants, which can help newer implanters learn vicariously both for standard practices in executing routine implants through activation and, importantly, for working through more challenging encounters with anatomy, special patient phenotypes, system testing, and troubleshooting. These tips should help new implanters handle most of the situations arising during implantation and avoid common pitfalls. Laryngoscope, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  5. Implantable optical-electrode device for stimulation of spinal motoneurons

    NASA Astrophysics Data System (ADS)

    Matveev, M. V.; Erofeev, A. I.; Zakharova, O. A.; Pyatyshev, E. N.; Kazakin, A. N.; Vlasova, O. L.

    2016-08-01

    Recent years, optogenetic method of scientific research has proved its effectiveness in the nerve cell stimulation tasks. In our article we demonstrate an implanted device for the spinal optogenetic motoneurons activation. This work is carried out in the Laboratory of Molecular Neurodegeneration of the Peter the Great St. Petersburg Polytechnic University, together with Nano and Microsystem Technology Laboratory. The work of the developed device is based on the principle of combining fiber optic light stimulation of genetically modified cells with the microelectrode multichannel recording of neurons biopotentials. The paper presents a part of the electrode implant manufacturing technique, combined with the optical waveguide of ThorLabs (USA).

  6. An Implanted, Stimulated Muscle Powered Piezoelectric Generator

    NASA Technical Reports Server (NTRS)

    Lewandowski, Beth; Gustafson, Kenneth; Kilgore, Kevin

    2007-01-01

    A totally implantable piezoelectric generator system able to harness power from electrically activated muscle could be used to augment the power systems of implanted medical devices, such as neural prostheses, by reducing the number of battery replacement surgeries or by allowing periods of untethered functionality. The features of our generator design are no moving parts and the use of a portion of the generated power for system operation and regulation. A software model of the system has been developed and simulations have been performed to predict the output power as the system parameters were varied within their constraints. Mechanical forces that mimic muscle forces have been experimentally applied to a piezoelectric generator to verify the accuracy of the simulations and to explore losses due to mechanical coupling. Depending on the selection of system parameters, software simulations predict that this generator concept can generate up to approximately 700 W of power, which is greater than the power necessary to drive the generator, conservatively estimated to be 50 W. These results suggest that this concept has the potential to be an implantable, self-replenishing power source and further investigation is underway.

  7. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  8. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  9. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  10. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  11. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  12. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  13. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  14. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  15. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  16. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  17. Soft Encapsulation of Flexible Electrical Stimulation Implant: Challenges and Innovations

    PubMed Central

    Debelle, Adrien; Hermans, Laura; Bosquet, Maxime; Dehaeck, Sam; Lonys, Laurent; Scheid, Benoit; Nonclercq, Antoine; Vanhoestenberghe, Anne

    2016-01-01

    In this document we discuss the main challenges encountered when producing flexible electrical stimulation implants, and present our approach to solving them for prototype production. We include a study of the optimization of the flexible PCB design, the selection of additive manufacturing materials for the mold, and the chemical compatibility of the different materials. Our approach was tested on a flexible gastro-stimulator as part of the ENDOGES research program. PMID:28078073

  18. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted neuromuscular stimulator. 882.5860 Section 882.5860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5860...

  19. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted cerebellar stimulator. 882.5820 Section 882.5820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820...

  20. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted cerebellar stimulator. 882.5820 Section 882.5820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820...

  1. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted cerebellar stimulator. 882.5820 Section 882.5820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820...

  2. Procedural safety of a fully implantable intravenous prostanoid pump for pulmonary hypertension.

    PubMed

    Richter, Manuel J; Ewert, Ralf; Warnke, Christian; Gall, Henning; Classen, Simon; Grimminger, Friedrich; Mayer, Eckhard; Seeger, Werner; Ghofrani, Hossein-Ardeschir

    2017-03-01

    In patients with severe pulmonary arterial hypertension, subcutaneous or catheter-based intravenous application of prostanoids carries a risk of local side effects or systemic infections, which limits their use and acceptance. Recently, a fully implantable pump for continuous application of intravenous treprostinil was approved in Germany. However, surgery is a major risk for patients with severe pulmonary arterial hypertension. The purpose of this study was to investigate the safety of a fully implantable pump inserted under local or general anesthesia in patients with severe pulmonary hypertension. All patients with pulmonary hypertension undergoing pump implantation for the continuous application of intravenous treprostinil were included from two German centers. Surgery was performed under local or general anesthesia according to the protocol of the recruiting center. Intra-operative safety and in-hospital complications were analyzed for the two different implantation regimens. In total, 51 patients were included. No major intra-operative complications were recorded. During the observation period, two patients died of progressive right heart failure, and two patients required treatment in the intensive care unit for acute right heart decompensation and respiratory failure. In total, major complications occurred in 8 out of 51 patients. Our observational study provides preliminary evidence supporting the procedural safety of a fully implantable pump inserted under local or general anesthesia for patients with severe pulmonary hypertension. The observation of major complications in a subset of patients requires extensive pre- and post-operative assessments. Future trials are required to provide further evidence for the long-term safety and efficacy of the pump using this approach.

  3. First permanent human implant of the Stimulus Router System, a novel neuroprosthesis: preliminary testing of a polarity reversing stimulation technique.

    PubMed

    Gan, Liu Shi; Ravid, Einat N; Kowalczewski, Jan; Gauthier, Michel; Olson, Jaret; Morhart, Michael; Prochazka, Arthur

    2011-01-01

    Neuroprostheses (NPs) are electrical stimulators that help to restore sensory or motor functions lost as a result of neural damage. The Stimulus Router System (SRS) is a new type of NP developed in our laboratory. The system uses fully implanted, passive leads to "capture" and "route" some of the current flowing between pairs of surface electrodes to the vicinity of the target nerves, hence eliminating the need for an implanted stimulator. In June 2008, 3 SRS leads were implanted in a tetraplegic man for restoration of grasp and release. To reduce the size of the external wristlet and thereby optimize usability, we recently implemented a polarity reversing stimulation technique that allowed us to eliminate a reference electrode. Selective activation of three target muscles was achieved by switching the polarities of the stimulus current delivered between pairs of surface electrodes located over the pick-up terminals of the implanted leads and reducing the amplitude of the secondary phases of the stimulus pulses.

  4. Intravenous treprostinil infusion via a fully implantable pump for pulmonary arterial hypertension.

    PubMed

    Ewert, Ralf; Richter, Manuel J; Steringer-Mascherbauer, Regina; Grünig, Ekkehard; Lange, Tobias J; Opitz, Christian F; Warnke, Christian; Ghofrani, Hossein-Ardeschir

    2017-04-20

    Parenteral prostanoids infused via external pumps are well-established pulmonary arterial hypertension (PAH) treatments. However, local side-effects and systemic infections restrict their use. The purpose of this study was to investigate the safety of a fully implantable treprostinil infusion pump (LENUS Pro(®)) in patients with PAH. Thirty patients with PAH undergoing pump implantation (with stable PAH therapy for ≥3 weeks pre-implantation) were included in this prospective, multicenter, observational study (NCT01979822). Primary endpoints were predefined adverse events (AEs) during implantation, in-hospital and/or during 6-month follow-up. Refill-related AEs were a secondary endpoint. Twenty-nine patients completed 6-month follow-up (one underwent lung transplantation). During implantation, one pneumothorax (not requiring drainage) occurred. Four patients had an in-hospital AE (including one catheter revision). During 6-month follow-up, AEs were most frequent at the first refill (10); the most common AE was seroma around the pump. No infections occurred. One pump required replacement because of a defective septum caused by use of a non-approved refill needle (associated with extravasation). Apart from the extravasation, no refill-related AEs were recorded. Post hoc efficacy analyses showed significant improvements in functional class [number in functional class I/II/III/IV: 0/5/21/2 (baseline) versus 3/8/17/0 (6 months); p = 0.012] and 6-min walk distance (mean ± standard deviation: 407 ± 122 m versus 445 ± 127 m; n = 17; p = 0.014). This study supports use of a fully implantable treprostinil infusion pump in patients with PAH requiring parenteral prostanoids. Refills should be performed by specialized healthcare professionals at patients' homes or at experienced centers using approved equipment.

  5. Pudendal Nerve Stimulation and Block by a Wireless Controlled Implantable Stimulator in Cats

    PubMed Central

    Yang, Guangning; Wang, Jicheng; Shen, Bing; Roppolo, James R.; de Groat, William C.; Tai, Changfeng

    2014-01-01

    Objective To determine the functionality of a wireless controlled implantable stimulator designed for stimulation and block of the pudendal nerve. Materials and Methods In 5 cats under α-chloralose anesthesia, the stimulator was implanted underneath the skin on the left side in the lower back along the sacral spine. Two tripolar cuff electrodes were implanted bilaterally on the pudendal nerves in addition to one bipolar cuff electrode that was implanted on the left side central to the tripolar cuff electrode. The stimulator provided high frequency (5-20 kHz) biphasic stimulation waveforms to the two tripolar electrodes and low frequency (1-100 Hz) rectangular pulses to the bipolar electrode. Bladder and urethral pressures were measured to determine the effects of pudendal nerve stimulation (PNS) or block. Results The maximal (70-100 cmH2O) urethral pressure generated by 20 Hz PNS applied via the bipolar electrode was completely eliminated by the pudendal nerve block induced by the high frequency stimulation (6-15 kHz, 6-10 V) applied via the two tripolar electrodes. In a partially filled bladder 20-30 Hz PNS (2-8 V, 0.2 ms) but not 5 Hz stimulation applied via the bipolar electrode elicited a large sustained bladder contraction (45.9±13.4 to 52.0±22 cmH2O). During cystometry, the 5 Hz PNS significantly (P<0.05) increased bladder capacity to 176.5±27.1% of control capacity. Conclusions The wireless controlled implantable stimulator successfully generated the required waveforms for stimulation and block of pudendal nerve, which will be useful for restoring bladder functions after spinal cord injury (SCI). PMID:24320615

  6. A New Trans-Tympanic Microphone Approach for Fully Implantable Hearing Devices.

    PubMed

    Woo, Seong Tak; Shin, Dong Ho; Lim, Hyung-Gyu; Seong, Ki-Woong; Gottlieb, Peter; Puria, Sunil; Lee, Kyu-Yup; Cho, Jin-Ho

    2015-09-09

    Fully implantable hearing devices (FIHDs) have been developed as a new technology to overcome the disadvantages of conventional acoustic hearing aids. The implantable microphones currently used in FIHDs, however, have difficulty achieving high sensitivity to environmental sounds, low sensitivity to body noise, and ease of implantation. In general, implantable microphones may be placed under the skin in the temporal bone region of the skull. In this situation, body noise picked up during mastication and touching can be significant, and the layer of skin and hair can both attenuate and distort sounds. The new approach presently proposed is a microphone implanted at the tympanic membrane. This method increases the microphone's sensitivity by utilizing the pinna's directionally dependent sound collection capabilities and the natural resonances of the ear canal. The sensitivity and insertion loss of this microphone were measured in human cadaveric specimens in the 0.1 to 16 kHz frequency range. In addition, the maximum stable gain due to feedback between the trans-tympanic microphone and a round-window-drive transducer, was measured. The results confirmed in situ high-performance capabilities of the proposed trans-tympanic microphone.

  7. A New Trans-Tympanic Microphone Approach for Fully Implantable Hearing Devices

    PubMed Central

    Woo, Seong Tak; Shin, Dong Ho; Lim, Hyung-Gyu; Seong, Ki-Woong; Gottlieb, Peter; Puria, Sunil; Lee, Kyu-Yup; Cho, Jin-Ho

    2015-01-01

    Fully implantable hearing devices (FIHDs) have been developed as a new technology to overcome the disadvantages of conventional acoustic hearing aids. The implantable microphones currently used in FIHDs, however, have difficulty achieving high sensitivity to environmental sounds, low sensitivity to body noise, and ease of implantation. In general, implantable microphones may be placed under the skin in the temporal bone region of the skull. In this situation, body noise picked up during mastication and touching can be significant, and the layer of skin and hair can both attenuate and distort sounds. The new approach presently proposed is a microphone implanted at the tympanic membrane. This method increases the microphone’s sensitivity by utilizing the pinna’s directionally dependent sound collection capabilities and the natural resonances of the ear canal. The sensitivity and insertion loss of this microphone were measured in human cadaveric specimens in the 0.1 to 16 kHz frequency range. In addition, the maximum stable gain due to feedback between the trans-tympanic microphone and a round-window-drive transducer, was measured. The results confirmed in situ high-performance capabilities of the proposed trans-tympanic microphone. PMID:26371007

  8. A Fully Implantable Pacemaker for the Mouse: From Battery to Wireless Power

    PubMed Central

    Zellmer, Erik R.; Weinheimer, Carla J.; MacEwan, Matthew R.; Cui, Sophia X.; Nerbonne, Jeanne M.; Efimov, Igor R.

    2013-01-01

    Animal models have become a popular platform for the investigation of the molecular and systemic mechanisms of pathological cardiovascular physiology. Chronic pacing studies with implantable pacemakers in large animals have led to useful models of heart failure and atrial fibrillation. Unfortunately, molecular and genetic studies in these large animal models are often prohibitively expensive or not available. Conversely, the mouse is an excellent species for studying molecular mechanisms of cardiovascular disease through genetic engineering. However, the large size of available pacemakers does not lend itself to chronic pacing in mice. Here, we present the design for a novel, fully implantable wireless-powered pacemaker for mice capable of long-term (>30 days) pacing. This design is compared to a traditional battery-powered pacemaker to demonstrate critical advantages achieved through wireless inductive power transfer and control. Battery-powered and wireless-powered pacemakers were fabricated from standard electronic components in our laboratory. Mice (n = 24) were implanted with endocardial, battery-powered devices (n = 14) and epicardial, wireless-powered devices (n = 10). Wireless-powered devices were associated with reduced implant mortality and more reliable device function compared to battery-powered devices. Eight of 14 (57.1%) mice implanted with battery-powered pacemakers died following device implantation compared to 1 of 10 (10%) mice implanted with wireless-powered pacemakers. Moreover, device function was achieved for 30 days with the wireless-powered device compared to 6 days with the battery-powered device. The wireless-powered pacemaker system presented herein will allow electrophysiology studies in numerous genetically engineered mouse models as well as rapid pacing-induced heart failure and atrial arrhythmia in mice. PMID:24194832

  9. A fully implantable pacemaker for the mouse: from battery to wireless power.

    PubMed

    Laughner, Jacob I; Marrus, Scott B; Zellmer, Erik R; Weinheimer, Carla J; MacEwan, Matthew R; Cui, Sophia X; Nerbonne, Jeanne M; Efimov, Igor R

    2013-01-01

    Animal models have become a popular platform for the investigation of the molecular and systemic mechanisms of pathological cardiovascular physiology. Chronic pacing studies with implantable pacemakers in large animals have led to useful models of heart failure and atrial fibrillation. Unfortunately, molecular and genetic studies in these large animal models are often prohibitively expensive or not available. Conversely, the mouse is an excellent species for studying molecular mechanisms of cardiovascular disease through genetic engineering. However, the large size of available pacemakers does not lend itself to chronic pacing in mice. Here, we present the design for a novel, fully implantable wireless-powered pacemaker for mice capable of long-term (>30 days) pacing. This design is compared to a traditional battery-powered pacemaker to demonstrate critical advantages achieved through wireless inductive power transfer and control. Battery-powered and wireless-powered pacemakers were fabricated from standard electronic components in our laboratory. Mice (n = 24) were implanted with endocardial, battery-powered devices (n = 14) and epicardial, wireless-powered devices (n = 10). Wireless-powered devices were associated with reduced implant mortality and more reliable device function compared to battery-powered devices. Eight of 14 (57.1%) mice implanted with battery-powered pacemakers died following device implantation compared to 1 of 10 (10%) mice implanted with wireless-powered pacemakers. Moreover, device function was achieved for 30 days with the wireless-powered device compared to 6 days with the battery-powered device. The wireless-powered pacemaker system presented herein will allow electrophysiology studies in numerous genetically engineered mouse models as well as rapid pacing-induced heart failure and atrial arrhythmia in mice.

  10. Electrophysiological channel interactions using focused multipolar stimulation for cochlear implants

    NASA Astrophysics Data System (ADS)

    George, Shefin S.; Shivdasani, Mohit N.; Wise, Andrew K.; Shepherd, Robert K.; Fallon, James B.

    2015-12-01

    Objective. Speech intelligibility with existing multichannel cochlear implants (CIs) is thought to be limited by poor spatial selectivity and interactions between CI channels caused by overlapping activation with monopolar (MP) stimulation. Our previous studies have shown that focused multipolar (FMP) and tripolar (TP) stimulation produce more restricted neural activation in the inferior colliculus (IC), compared to MP stimulation. Approach. This study explored interactions in the IC produced by simultaneous stimulation of two CI channels. We recorded multi-unit neural activity in the IC of anaesthetized cats with normal and severely degenerated spiral ganglion neuron populations in response to FMP, TP and MP stimulation from a 14 channel CI. Stimuli were applied to a ‘fixed’ CI channel, chosen toward the middle of the cochlear electrode array, and the effects of simultaneously stimulating a more apical ‘test’ CI channel were measured as a function of spatial separation between the two stimulation channels and stimulus level of the fixed channel. Channel interactions were quantified by changes in neural responses and IC threshold (i.e., threshold shift) elicited by simultaneous stimulation of two CI channels, compared to stimulation of the test channel alone. Main results. Channel interactions were significantly lower for FMP and TP than for MP stimulation (p < 0.001), whereas no significant difference was observed between FMP and TP stimulation. With MP stimulation, threshold shifts increased with decreased inter-electrode spacing and increased stimulus levels of the fixed channel. For FMP and TP stimulation, channel interactions were found to be similar for different inter-electrode spacing and stimulus levels of the fixed channel. Significance. The present study demonstrates how the degree of channel interactions in a CI can be controlled using stimulation configurations such as FMP and TP; such knowledge is essential in enhancing CI function in complex

  11. Sacral nerve stimulation lead implantation using the o-arm

    PubMed Central

    2013-01-01

    Background Sacral neuromodulation operations have usually been performed based on 2D fluoro images. However, sacral nerve stimulation lead implantation may be challenging when the normal anatomy is confused by obesity or congenital anomalies. Thus the surgical navigation and intraoperative imaging methods could be helpful as those same methods have proven to be feasible methods for guiding other surgical operations. Our recent knowledge about the O-arm in trauma pelvic operations encouraged us to evaluate the usefulness of O-arm guided navigation in sacral neuromodulation. Similar navigation would be useful for complex sacral nerve stimulation lead implantations. Methods In this preliminary article we report our experience of utilizing the orthopedically optimized O-arm to implant the S3 stimulation electrode in a patient. The 3D O-arm imaging was performed intraoperatively under surgical navigation control. General anesthesia was used. The obtained 3D image dataset was registered automatically into the patient’s anatomy. The stimulation needle was guided and the tined lead electrode was implanted using navigation. Results The bony sacral structures were clearly visualized. Due to automatic registration, the navigation was practicable instantly after the O-arm scanning and operation could be performed successfully under navigation control. Conclusions To our knowledge, this is the first published tined lead implantation which was guided based on the surgical navigation and intraoperative O-arm images. In this case, the applied method was useful and helped the surgeon to demarcate the region of surgical interest. The method is slightly more invasive than the formal technique but could be an option in anatomically challenging cases and reoperations. However, further evaluation with larger patient series is required before definitive recommendations can be made. PMID:24131790

  12. Spinal cord stimulation for refractory angina in a patient implanted with a cardioverter defibrillator.

    PubMed

    Ferrero, Paolo; Grimaldi, Roberto; Massa, Riccardo; Chiribiri, Amedeo; De Luca, Anna; Castellano, Maddalena; Cardano, Paola; Trevi, Gian Paolo

    2007-01-01

    Spinal cord stimulation is currently used to treat refractory angina. Some concerns may arise about the possible interaction concerning the spinal cord stimulator in patients already implanted with a pacemaker or a cardioverter defibrillator. We are going to describe the successful implantation of a spinal cord stimulator in a patient previously implanted with a cardioverter defibrillator.

  13. Fully implantable Otologics MET Carina™ device for the treatment of sensorineural hearing loss. Preliminary surgical and clinical results

    PubMed Central

    Bruschini, L; Forli, F; Santoro, A; Bruschini, P; Berrettini, S

    2009-01-01

    Summary Middle ear implants overcome some of the common problems of conventional hearing aid technology, such as feedback, signal distortion, ear canal occlusion and associated issues. The Otologics MET Carina™, Boulder, CO, USA, is a fully implantable hearing prosthesis designed to address the amplification needs of adults (> 18 years of age), with moderate to severe sensorineural hearing loss and normal middle ears, providing a mechanical direct stimulation of middle ear ossicles. Recently, it has been successfully used also in patients with conductive hearing loss. In the present report, personal surgical and clinical experience with the fully implantable Carina™ is described in 5 adults with moderate to severe sensorineural hearing loss, operated upon between November 2007 and May 2008 in the ENT Unit, University of Pisa. Mean follow-up was 10.2 months of device use (range 7-13). Surgery was performed under general anaesthesia, in ~3 hours, with no surgical complications in any of the patients. In these 5 cases, no significant post-operative variation was observed in hearing thresholds, either for air or bone conduction, indicating absence of surgical damage to the cochlea. All patients showed improvements in hearing thresholds, in free field and in speech perception abilities, with the device functioning, moreover, they reported subjective benefits. With regard to post-operative adverse effects, no cases of extrusion of the device, device failure, loss of external communication or increased charging times were observed. Problems of feedback noise occurred, which were resolved with minor fitting adjustments in 4 cases, while a second operation was required to change the microphone position in the other patient. The present results, in agreement with those reported in the literature, confirm that the Otologics MET Carina™ is viable treatment for moderate to severe sensorineural hearing loss and, in selected cases, may represent an alternative to

  14. Occipital nerve stimulation: technical and surgical aspects of implantation.

    PubMed

    Trentman, Terrence L; Zimmerman, Richard S

    2008-02-01

    The objective of this article is to review the surgical aspects of occipital stimulation. Since 1999 there has been a growing interest in neuromodulation of the distal branches of C2-3 in an effort to treat refractory headache disorders. This is accomplished via implantation of subcutaneous electrodes to stimulate peripheral nerves in the occipital region. "Occipital nerve stimulation" is a term generically used to describe the technique. Mechanisms and outcome of this modality are beyond the scope of this review, which will focus on the technical aspects of the procedure with its associated complications such as lead migration, localized pain, and infection. The history of peripheral nerve and spinal cord stimulation as pain treatment modalities will be briefly reviewed. The equipment and surgical technique for both trial and permanent implantation of occipital nerve stimulators will be described, in addition to patient selection considerations. The available literature will be summarized and a discussion of future directions will be provided. Occipital nerve stimulation may be an effective minimally invasive treatment modality for refractory headache disorders; clearly, further studies are needed.

  15. Fully Implanted Brain-Computer Interface in a Locked-In Patient with ALS.

    PubMed

    Vansteensel, Mariska J; Pels, Elmar G M; Bleichner, Martin G; Branco, Mariana P; Denison, Timothy; Freudenburg, Zachary V; Gosselaar, Peter; Leinders, Sacha; Ottens, Thomas H; Van Den Boom, Max A; Van Rijen, Peter C; Aarnoutse, Erik J; Ramsey, Nick F

    2016-11-24

    Options for people with severe paralysis who have lost the ability to communicate orally are limited. We describe a method for communication in a patient with late-stage amyotrophic lateral sclerosis (ALS), involving a fully implanted brain-computer interface that consists of subdural electrodes placed over the motor cortex and a transmitter placed subcutaneously in the left side of the thorax. By attempting to move the hand on the side opposite the implanted electrodes, the patient accurately and independently controlled a computer typing program 28 weeks after electrode placement, at the equivalent of two letters per minute. The brain-computer interface offered autonomous communication that supplemented and at times supplanted the patient's eye-tracking device. (Funded by the Government of the Netherlands and the European Union; ClinicalTrials.gov number, NCT02224469 .).

  16. Fully Implanted Brain–Computer Interface in a Locked-In Patient with ALS

    PubMed Central

    Bleichner, Martin G.; Branco, Mariana P.; Denison, Timothy; Freudenburg, Zachary V.; Gosselaar, Peter; Leinders, Sacha; Ottens, Thomas H.; Van Den Boom, Max A.; Van Rijen, Peter C.; Ramsey, Nick F.

    2017-01-01

    Summary Options for people with severe paralysis who have lost the ability to communicate orally are limited. We describe a method for communication in a patient with late-stage amyotrophic lateral sclerosis (ALS), involving a fully implanted brain–computer interface that consists of subdural electrodes placed over the motor cortex and a transmitter placed subcutaneously in the left side of the thorax. By attempting to move the hand on the side opposite the implanted electrodes, the patient accurately and independently controlled a computer typing program 28 weeks after electrode placement, at the equivalent of two letters per minute. The brain–computer interface offered autonomous communication that supplemented and at times supplanted the patient’s eye-tracking device. (Funded by the Government of the Netherlands and the European Union; ClinicalTrials.gov number, NCT02224469.) PMID:27959736

  17. A novel, fully implantable, multichannel biotelemetry system for measurement of blood flow, pressure, ECG, and temperature.

    PubMed

    Axelsson, M; Dang, Q; Pitsillides, K; Munns, S; Hicks, J; Kassab, G S

    2007-03-01

    Biotelemetry provides high-quality data in awake, free-ranging animals without the effects of anesthesia and surgery. Although many biological parameters can be measured using biotelemetry, simultaneous telemetric measurements of pressure and flow have not been available. The objective of this study was to evaluate simultaneous measurements of blood flow, pressure, ECG, and temperature in a fully implantable system. This novel system allows the measurement of up to four channels of blood flow, up to three channels of pressure, and a single channel each of ECG and temperature. The system includes a bidirectional radio-frequency link that allows the implant to send data and accept commands to perform various tasks. The system is controlled by a base station decoder/controller that decodes the data stream sent by the implant into analog signals. The system also converts the data into a digital data stream that can be sent via ethernet to a remote computer for storage and/or analysis. The system was chronically implanted in swine and alligators for up to 5 wk. Both bench and in vivo animal tests were performed to evaluate system performance. Results show that this biotelemetry system is capable of long-term accurate monitoring of simultaneous blood flow and pressure. The system allows, within the room, recordings, since the implant transmission range is between 6 and 10 m, and, with a relay, backpack transmission distance of up to 500 m can be achieved. This system will have significant utility in chronic models of cardiovascular physiology and pathology.

  18. Effects of stimulation rate on speech recognition with cochlear implants.

    PubMed

    Friesen, Lendra M; Shannon, Robert V; Cruz, Rachel J

    2005-01-01

    Phoneme and speech recognition were measured as a function of stimulation pulse rate in 12 listeners with three types of cochlear implants. Identification of consonants and vowels and recognition of words and sentences were measured in 5 Clarion C1 subjects fit with continuous interleaved sampling (CIS) processors having 4 or 8 electrodes, 4 Nucleus 24 subjects fit with CIS processors having 4, 8, 12 or 16 electrodes and 3 Clarion C2 subjects fit with CIS processors with 4, 8, 12 and 16 electrodes. Stimulation rates ranged from 200 to more than 5000 Hz per electrode, depending on the device, number of electrodes used and stimulation strategy. Listeners were also tested on the same materials with their original processor prior to receiving the experimental processors. All testing was done in quiet listening conditions with essentially no practice with the experimental processor prior to data collection. Listeners scored the highest with their original processor. Little difference in speech understanding was observed for listener scores with processors using different stimulation rates. Speech recognition was significantly poorer only at the lowest stimulation rate and at high rates that used noninterleaved pulses. Speech recognition was similar for processors using 8, 12 or 16 electrodes. Only 4-electrode processors produced a significantly poorer performance. These results suggest that patients with present commercial implants are not able to make full use of the number of channels of spectral information delivered by the present speech processors. In addition, the results show no significant change in performance as a function of stimulation rate, suggesting that high stimulation rates do not result in improved access to temporal cues in speech, at least under quiet listening conditions. Copyright 2005 S. Karger AG, Basel.

  19. Fixation of the fully hydroxyapatite-coated Corail stem implanted due to femoral neck fracture

    PubMed Central

    2012-01-01

    Background Today, dislocated femoral neck fractures are commonly treated with a cemented hip arthroplasty. However, cementing of the femoral component may lead to adverse effects and even death. Uncemented stems may lower these risks and hydroxyapatite (HA) coating may enhance integration, but prosthetic stability and clinical outcome in patients with osteoporotic bone have not been fully explored. We therefore studied fixation and clinical outcome in patients who had had a femoral neck fracture and who had received a fully HA-coated stem prosthesis. Patients and methods 50 patients with a dislocated femoral neck fracture were operated with the fully HA-coated Corail total or hemiarthroplasty. 38 patients, mean age 81 (70–96) years, were followed for 24 months with conventional radiographs, RSA, DEXA, and for clinical outcome. Results 31 of the 38 implants moved statistically significantly up to 3 months, mainly distally, mean 2.7 mm (max. 20 mm (SD 4.3)), and rotated into retroversion mean 3.3º (–1.8 to 17) (SD 4.3) and then appeared to stabilize. Distal stem migration was more pronounced if the stem was deemed to be too small. There was no correlation between BMD and stem migration. The migration did not result in any clinically adverse effects. Interpretation The fully hydroxyapatite-coated Corail stem migrates during the first 3 months, but clinical outcome appears to be good, without any adverse events. PMID:22112154

  20. An NFC-Enabled CMOS IC for a Wireless Fully Implantable Glucose Sensor.

    PubMed

    DeHennis, Andrew; Getzlaff, Stefan; Grice, David; Mailand, Marko

    2016-01-01

    This paper presents an integrated circuit (IC) that merges integrated optical and temperature transducers, optical interface circuitry, and a near-field communication (NFC)-enabled digital, wireless readout for a fully passive implantable sensor platform to measure glucose in people with diabetes. A flip-chip mounted LED and monolithically integrated photodiodes serve as the transduction front-end to enable fluorescence readout. A wide-range programmable transimpedance amplifier adapts the sensor signals to the input of an 11-bit analog-to-digital converter digitizing the measurements. Measurement readout is enabled by means of wireless backscatter modulation to a remote NFC reader. The system is able to resolve current levels of less than 10 pA with a single fluorescent measurement energy consumption of less than 1 μJ. The wireless IC is fabricated in a 0.6-μm-CMOS process and utilizes a 13.56-MHz-based ISO15693 for passive wireless readout through a NFC interface. The IC is utilized as the core interface to a fluorescent, glucose transducer to enable a fully implantable sensor-based continuous glucose monitoring system.

  1. [Fully implantable intramedullary distraction nail in shortening deformity and bone defects. Spectrum of indications].

    PubMed

    Baumgart, R; Zeiler, C; Kettler, M; Weiss, S; Schweiberer, L

    1999-12-01

    Since the first clinical experiences with the fully implantable programmable distraction nail nearly ten years ago, the system has been improved in Munich and meanwhile used in 26 patients. During the first 10 cases there has been highest interest in the reliability of the system, while in the following the expansion of indications was more important. At the thigh a good indication beside shortening is the combination of shortening and axis deviation, even if the center of deviation is located near to the knee joint in the supracondylar area. According to preoperative planing the deformity correction can be done acutely while the lengthening procedure follows postoperatively automatically at night-time. If the stabilization with an intramedullary nail is possible, large bone defects can be treated by bone transport using this system also. The fully implantable intramedullary nail has proved its variable functions in cases of large bone defects combined with shortening of the femur. The system is able to perform the bone transport at first and the lengthening procedure automatically without any further operation thereafter.

  2. Abnormal Pitch Perception Produced by Cochlear Implant Stimulation

    PubMed Central

    Zeng, Fan-Gang; Tang, Qing; Lu, Thomas

    2014-01-01

    Contemporary cochlear implants with multiple electrode stimulation can produce good speech perception but poor music perception. Hindered by the lack of a gold standard to quantify electric pitch, relatively little is known about the nature and extent of the electric pitch abnormalities and their impact on cochlear implant performance. Here we overcame this obstacle by comparing acoustic and electric pitch perception in 3 unilateral cochlear-implant subjects who had functionally usable acoustic hearing throughout the audiometric frequency range in the non-implant ear. First, to establish a baseline, we measured and found slightly impaired pure tone frequency discrimination and nearly perfect melody recognition in all 3 subjects’ acoustic ear. Second, using pure tones in the acoustic ear to match electric pitch induced by an intra-cochlear electrode, we found that the frequency-electrode function was not only 1–2 octaves lower, but also 2 times more compressed in frequency range than the normal cochlear frequency-place function. Third, we derived frequency difference limens in electric pitch and found that the equivalent electric frequency discrimination was 24 times worse than normal-hearing controls. These 3 abnormalities are likely a result of a combination of broad electric field, distant intra-cochlear electrode placement, and non-uniform spiral ganglion cell distribution and survival, all of which are inherent to the electrode-nerve interface in contemporary cochlear implants. Previous studies emphasized on the “mean” shape of the frequency-electrode function, but the present study indicates that the large “variance” of this function, reflecting poor electric pitch discriminability, is the main factor limiting contemporary cochlear implant performance. PMID:24551131

  3. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted spinal cord stimulator for bladder....5850 Implanted spinal cord stimulator for bladder evacuation. (a) Identification. An implanted spinal... paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or...

  4. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted spinal cord stimulator for bladder....5850 Implanted spinal cord stimulator for bladder evacuation. (a) Identification. An implanted spinal... paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or...

  5. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted spinal cord stimulator for bladder....5850 Implanted spinal cord stimulator for bladder evacuation. (a) Identification. An implanted spinal... paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or...

  6. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted spinal cord stimulator for bladder....5850 Implanted spinal cord stimulator for bladder evacuation. (a) Identification. An implanted spinal... paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or...

  7. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted spinal cord stimulator for bladder....5850 Implanted spinal cord stimulator for bladder evacuation. (a) Identification. An implanted spinal... paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or...

  8. Operative and technical complications of vagus nerve stimulator implantation.

    PubMed

    Spuck, Sebastian; Tronnier, Volker; Orosz, Iren; Schönweiler, Rainer; Sepehrnia, Abolgassem; Nowak, Georg; Sperner, Jürgen

    2010-12-01

    The treatment of refractory epilepsy by vagus nerve stimulation (VNS) is a well-established therapy option for patients not suitable for epilepsy surgery and therapy refractory depressions. To analyze surgical and technical complications after implantation of left-sided VNS in patients with therapy-refractory epilepsy and depression. One hundred five patients receiving a VNS or VNS-related operations (n = 118) from 1999 to 2008 were investigated retrospectively. At the time of operation, 84 patients were younger than 18 years, with a mean age of 10.5 years. Twenty (19%) patients had technical problems or complications. In 6 (5.7%) patients these problems were caused by the operation. The device was removed in 8 cases. The range of surgically and technically induced complications included electrode fractures, early and late onset of deep wound infections, transient vocal cord palsy, cardiac arrhythmia under test stimulation, electrode malfunction, and posttraumatic dysfunction of the stimulator. VNS therapy is combined with a wide spread of possible complications. Technical problems are to be expected, including electrode fracture, dislocation, and generator malfunction. The major complication in younger patients is the electrode fracture, which might be induced by growth during adolescence. Surgically induced complications of VNS implantation are comparably low. Cardiac symptoms and recurrent nerve palsy need to be taken into consideration.

  9. Implementation of integrated circuit and design of SAR ADC for fully implantable hearing aids.

    PubMed

    Kim, Jong Hoon; Lee, Jyung Hyun; Cho, Jin-Ho

    2017-07-20

    The hearing impaired population has been increasing; many people suffer from hearing problems. To deal with this difficulty, various types of hearing aids are being rapidly developed. In particular, fully implantable hearing aids are being actively studied to improve the performance of existing hearing aids and to reduce the stigma of hearing loss patients. It has to be of small size and low-power consumption for easy implantation and long-term use. The objective of the study was to implement a small size and low-power consumption successive approximation register analog-to-digital converter (SAR ADC) for fully implantable hearing aids. The ADC was selected as the SAR ADC because its analog circuit components are less required by the feedback circuit of the SAR ADC than the sigma-delta ADC which is conventionally used in hearing aids, and it has advantages in the area and power consumption. So, the circuit of SAR ADC is designed considering the speech region of humans because the objective is to deliver the speech signals of humans to hearing loss patients. If the switch of sample and hold works in the on/off positions, the charge injection and clock feedthrough are produced by a parasitic capacitor. These problems affect the linearity of the hold voltage, and as a result, an error of the bit conversion is generated. In order to solve the problem, a CMOS switch that consists of NMOS and PMOS was used, and it reduces the charge injection because the charge carriers in the NMOS and PMOS have inversed polarity. So, 16 bit conversion is performed before the occurrence of the Least Significant Bit (LSB) error. In order to minimize the offset voltage and power consumption of the designed comparator, we designed a preamplifier with current mirror. Therefore, the power consumption was reduced by the power control switch used in the comparator. The layout of the designed SAR ADC was performed by Virtuoso Layout Editor (Cadence, USA). In the layout result, the size of the

  10. Design and Evaluation of a Robust PID Controller for a Fully Implantable Artificial Pancreas.

    PubMed

    Huyett, Lauren M; Dassau, Eyal; Zisser, Howard C; Doyle, Francis J

    2015-10-28

    Treatment of type 1 diabetes mellitus could be greatly improved by applying a closed-loop control strategy to insulin delivery, also known as an artificial pancreas (AP). In this work, we outline the design of a fully implantable AP using intraperitoneal (IP) insulin delivery and glucose sensing. The design process utilizes the rapid glucose sensing and insulin action offered by the IP space to tune a PID controller with insulin feedback to provide safe and effective insulin delivery. The controller was tuned to meet robust performance and stability specifications. An anti-reset windup strategy was introduced to prevent dangerous undershoot toward hypoglycemia after a large meal disturbance. The final controller design achieved 78% of time within the tight glycemic range of 80-140 mg/dL, with no time spent in hypoglycemia. The next step is to test this controller design in an animal model to evaluate the in vivo performance.

  11. Design and Evaluation of a Robust PID Controller for a Fully Implantable Artificial Pancreas

    PubMed Central

    2015-01-01

    Treatment of type 1 diabetes mellitus could be greatly improved by applying a closed-loop control strategy to insulin delivery, also known as an artificial pancreas (AP). In this work, we outline the design of a fully implantable AP using intraperitoneal (IP) insulin delivery and glucose sensing. The design process utilizes the rapid glucose sensing and insulin action offered by the IP space to tune a PID controller with insulin feedback to provide safe and effective insulin delivery. The controller was tuned to meet robust performance and stability specifications. An anti-reset windup strategy was introduced to prevent dangerous undershoot toward hypoglycemia after a large meal disturbance. The final controller design achieved 78% of time within the tight glycemic range of 80–140 mg/dL, with no time spent in hypoglycemia. The next step is to test this controller design in an animal model to evaluate the in vivo performance. PMID:26538805

  12. System overview of the fully implantable destination therapy--ReinHeart-total artificial heart.

    PubMed

    Pelletier, Benedikt; Spiliopoulos, Sotirios; Finocchiaro, Thomas; Graef, Felix; Kuipers, Kristin; Laumen, Marco; Guersoy, Dilek; Steinseifer, Ulrich; Koerfer, Reiner; Tenderich, Gero

    2015-01-01

    Owing to the lack of suitable allografts, the demand for long-term mechanical circulatory support in patients with biventricular end-stage heart failure is rising. Currently available Total Artificial Heart (TAH) systems consist of pump units with only limited durability, percutaneous tubes and bulky external equipment that limit the quality of life. Therefore we are focusing on the development of a fully implantable, highly durable destination therapy total artificial heart. The ReinHeart-TAH system consists of a passively filling pump unit driven by a low-wear linear drive between two artificial ventricles, an implantable control unit and a compliance chamber. The TAH is powered by a transcutaneous energy transmission system. The flow distribution inside the ventricles was analysed by fluid structure interaction simulation and particle image velocimetry measurements. Along with durability tests, the hydrodynamic performance and flow balance capability were evaluated in a mock circulation loop. Animal trials are ongoing. Based on fluid structure interaction simulation and particle image velocimetry, blood stagnation areas have been significantly reduced. In the mock circulation loop the ReinHeart-TAH generated a cardiac output of 5 l/min at an operating frequency of 120 bpm and an aortic pressure of 120/80 mmHg. The highly effective preload sensitivity of the passively filling ventricles allowed the sensorless integration of the Frank Starling mechanism. The ReinHeart-TAH effectively replaced the native heart's function in animals for up to 2 days. In vitro and in vivo testing showed a safe and effective function of the ReinHeart-TAH system. This has the potential to become an alternative to transplantation. However, before a first-in-man implant, chronic animal trials still have to be completed. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  13. Carina® and Esteem®: A Systematic Review of Fully Implantable Hearing Devices

    PubMed Central

    Pulcherio, Janaina Oliveira Bentivi; Bittencourt, Aline Gomes; Burke, Patrick Rademaker; Monsanto, Rafael da Costa; de Brito, Rubens; Tsuji, Robinson Koji; Bento, Ricardo Ferreira

    2014-01-01

    Objective To review the outcomes of the fully implantable middle ear devices Carina and Esteem regarding the treatment of hearing loss. Data Sources PubMed, Embase, Scielo, and Cochrane Library databases were searched. Study Selection Abstracts of 77 citations were screened, and 43 articles were selected for full review. From those, 22 studies and two literature reviews in English directly demonstrating the results of Carina and Esteem were included. Data Extraction There were a total of 244 patients ranging from 18 to 88 years. One hundred and 10 patients were implanted with Carina and with 134 Esteem. There were registered 92 males and 67 females. Five studies provided no information about patients’ age or gender. From the data available, the follow-up ranged from 2 to 29.4 months. Data Synthesis The comparison of the results about word recognition is difficult as there was no standardization of measurement. The results were obtained from various sound intensities and different frequencies. The outcomes comparing to conventional HAs were conflicting. Nevertheless, all results comparing to unaided condition showed improvement and showed a subjective improvement of quality of life. Conclusion There are still some problems to be solved, mainly related to device functioning and price. Due to the relatively few publications available and small sample sizes, we must be careful in extrapolating these results to a broader population. Additionally, none of all these studies represented level high levels of evidence (i.e. randomized controlled trials). PMID:25329463

  14. A 32-channel fully implantable wireless neurosensor for simultaneous recording from two cortical regions

    PubMed Central

    Aceros, Juan; Yin, Ming; Borton, David A.; Patterson, William R.; Nurmikko, Arto V.

    2014-01-01

    We present a fully implantable, wireless, neurosensor for multiple-location neural interface applications. The device integrates two independent 16-channel intracortical microelectrode arrays and can simultaneously acquire 32 channels of broadband neural data from two separate cortical areas. The system-on-chip implantable sensor is built on a flexible Kapton polymer substrate and incorporates three very low power subunits: two cortical subunits connected to a common subcutaneous subunit. Each cortical subunit has an ultra-low power 16-channel preamplifier and multiplexer integrated onto a cortical microelectrode array. The subcutaneous epicranial unit has an inductively coupled power supply, two analog-to-digital converters, a low power digital controller chip, and microlaser-based infrared telemetry. The entire system is soft encapsulated with biocompatible flexible materials for in vivo applications. Broadband neural data is conditioned, amplified, and analog multiplexed by each of the cortical subunits and passed to the subcutaneous component, where it is digitized and combined with synchronization data and wirelessly transmitted transcutaneously using high speed infrared telemetry. PMID:22254801

  15. Design and Evaluation of a Fully Implantable Control Unit for Blood Pumps

    PubMed Central

    Unthan, Kristin; Gräf, Felix; Laumen, Marco; Finocchiaro, Thomas; Sommer, Christoph; Lanmüller, Hermann; Steinseifer, Ulrich

    2015-01-01

    As the number of donor hearts is limited while more and more patients suffer from end stage biventricular heart failure, Total Artificial Hearts become a promising alternative to conventional treatment. While pneumatic devices sufficiently supply the patients with blood flow, the patient's quality of life is limited by the percutaneous pressure lines and the size of the external control unit. This paper describes the development of the control unit of the ReinHeart, a fully implantable Total Artificial Heart. General requirements for any implantable control unit are defined from a technical and medical point of view: necessity of a Transcutaneous Energy Transmission, autonomous operation, safety, geometry, and efficiency. Based on the requirements, a prototype is designed; it incorporates a LiFePo4 battery pack with charger, a rectifier for transcutaneous energy transmission, the motor's driver electronics, and a microcontroller which monitors and controls all functions. In validation tests, the control unit demonstrated a stable operation on TET and battery supply and a safe switching from one supply to the other. The overall mean efficiency is 14% on TET and 22% on battery supply. The control unit is suitable for chronic animal trials of the ReinHeart. PMID:26583095

  16. Design and Evaluation of a Fully Implantable Control Unit for Blood Pumps.

    PubMed

    Unthan, Kristin; Gräf, Felix; Laumen, Marco; Finocchiaro, Thomas; Sommer, Christoph; Lanmüller, Hermann; Steinseifer, Ulrich

    2015-01-01

    As the number of donor hearts is limited while more and more patients suffer from end stage biventricular heart failure, Total Artificial Hearts become a promising alternative to conventional treatment. While pneumatic devices sufficiently supply the patients with blood flow, the patient's quality of life is limited by the percutaneous pressure lines and the size of the external control unit. This paper describes the development of the control unit of the ReinHeart, a fully implantable Total Artificial Heart. General requirements for any implantable control unit are defined from a technical and medical point of view: necessity of a Transcutaneous Energy Transmission, autonomous operation, safety, geometry, and efficiency. Based on the requirements, a prototype is designed; it incorporates a LiFePo4 battery pack with charger, a rectifier for transcutaneous energy transmission, the motor's driver electronics, and a microcontroller which monitors and controls all functions. In validation tests, the control unit demonstrated a stable operation on TET and battery supply and a safe switching from one supply to the other. The overall mean efficiency is 14% on TET and 22% on battery supply. The control unit is suitable for chronic animal trials of the ReinHeart.

  17. Carina® and Esteem®: a systematic review of fully implantable hearing devices.

    PubMed

    Pulcherio, Janaina Oliveira Bentivi; Bittencourt, Aline Gomes; Burke, Patrick Rademaker; Monsanto, Rafael da Costa; de Brito, Rubens; Tsuji, Robinson Koji; Bento, Ricardo Ferreira

    2014-01-01

    To review the outcomes of the fully implantable middle ear devices Carina and Esteem regarding the treatment of hearing loss. PubMed, Embase, Scielo, and Cochrane Library databases were searched. Abstracts of 77 citations were screened, and 43 articles were selected for full review. From those, 22 studies and two literature reviews in English directly demonstrating the results of Carina and Esteem were included. There were a total of 244 patients ranging from 18 to 88 years. One hundred and 10 patients were implanted with Carina and with 134 Esteem. There were registered 92 males and 67 females. Five studies provided no information about patients' age or gender. From the data available, the follow-up ranged from 2 to 29.4 months. The comparison of the results about word recognition is difficult as there was no standardization of measurement. The results were obtained from various sound intensities and different frequencies. The outcomes comparing to conventional HAs were conflicting. Nevertheless, all results comparing to unaided condition showed improvement and showed a subjective improvement of quality of life. There are still some problems to be solved, mainly related to device functioning and price. Due to the relatively few publications available and small sample sizes, we must be careful in extrapolating these results to a broader population. Additionally, none of all these studies represented level high levels of evidence (i.e. randomized controlled trials).

  18. The management of leg-length discrepancy in Ollier's disease with a fully implantable lengthening nail.

    PubMed

    Baumgart, R; Bürklein, D; Hinterwimmer, S; Thaller, P; Mutschler, W

    2005-07-01

    Ollier's disease is characterised by severe deformity of the extremities and retarded growth because of multiple enchondromas. For correction of deformity, the Ilizarov method has been used although it has many complications. A 17-year-old boy with Ollier's disease had a limb-length discrepancy of 17.4 cm, with a valgus deformity of the right knee and recurvatum of the femur of 23 degrees . He had undergone three unsuccessful attempts to correct the deformities by using external fixators. We used a fully implantable, motorised, lengthening and correction nail (Fitbone) to achieve full correction of all the deformities without complications. We decided to carry out the procedure in three stages. First, we lengthened the femur by 3.6 cm and the tibia by 4 cm. We then exchanged the femoral nail for a longer implant and achieved a further 6 cm of length. This reduced the shortening to 3.8 cm. When the boy has finished secondary school we will adjust the remaining discrepancy.

  19. A 32-channel fully implantable wireless neurosensor for simultaneous recording from two cortical regions.

    PubMed

    Aceros, Juan; Yin, Ming; Borton, David A; Patterson, William R; Nurmikko, Arto V

    2011-01-01

    We present a fully implantable, wireless, neurosensor for multiple-location neural interface applications. The device integrates two independent 16-channel intracortical microelectrode arrays and can simultaneously acquire 32 channels of broadband neural data from two separate cortical areas. The system-on-chip implantable sensor is built on a flexible Kapton polymer substrate and incorporates three very low power subunits: two cortical subunits connected to a common subcutaneous subunit. Each cortical subunit has an ultra-low power 16-channel preamplifier and multiplexer integrated onto a cortical microelectrode array. The subcutaneous epicranial unit has an inductively coupled power supply, two analog-to-digital converters, a low power digital controller chip, and microlaser-based infrared telemetry. The entire system is soft encapsulated with biocompatible flexible materials for in vivo applications. Broadband neural data is conditioned, amplified, and analog multiplexed by each of the cortical subunits and passed to the subcutaneous component, where it is digitized and combined with synchronization data and wirelessly transmitted transcutaneously using high speed infrared telemetry.

  20. Microchip-Embedded Capacitors for Implantable Neural Stimulators

    NASA Astrophysics Data System (ADS)

    Auciello, Orlando

    Miniaturization of microchips for implantation in the human body (e.g., microchip for the artificial retina to restore sight to people blinded by retina photoreceptors degeneration) requires the integration of high-capacitance (≥ 10 μF) energy-storage capacitors into the microchip. These capacitors would be based on high-dielectric constant layers, preferably made of materials that are bioinert (not affected by human body fluids) and are biocompatible (do not elicit adverse reactions in the human body). This chapter focuses on reviewing the work being done at Argonne National Laboratory (Materials Science Division and Center for Nanoscale Materials) to develop high-capacitance microchip-embedded capacitors based on novel high-K dielectric layers (TiAlOx or TiO2/Al2O3 superlattices). The microchip-embedded capacitor provides energy storage and electromagnetic signal coupling needed for neural stimulations. Advances in neural prostheses such as artificial retinas and cochlear implants require miniaturization of device size to minimize tissue damage and improve device/tissue interfaces in the human body. Therefore, development of microchip-embedded capacitors is critical to achieve full-implantable biomedical device miniaturization.

  1. Numerical simulation of electrically stimulated osteogenesis in dental implants.

    PubMed

    Vanegas-Acosta, J C; Garzón-Alvarado, D A; Lancellotti, V

    2014-04-01

    Cell behavior and tissue formation are influenced by a static electric field (EF). Several protocols for EF exposure are aimed at increasing the rate of tissue recovery and reducing the healing times in wounds. However, the underlying mechanisms of the EF action on cells and tissues are still a matter of research. In this work we introduce a mathematical model for electrically stimulated osteogenesis at the bone-dental implant interface. The model describes the influence of the EF in the most critical biological processes leading to bone formation at the bone-dental implant interface. The numerical solution is able to reproduce the distribution of spatial-temporal patterns describing the influence of EF during blood clotting, osteogenic cell migration, granulation tissue formation, displacements of the fibrillar matrix, and formation of new bone. In addition, the model describes the EF-mediated cell behavior and tissue formation which lead to an increased osteogenesis in both smooth and rough implant surfaces. Since numerical results compare favorably with experimental evidence, the model can be used to predict the outcome of using electrostimulation in other types of wounds and tissues. Copyright © 2013 Elsevier B.V. All rights reserved.

  2. Rescue pallidotomy for dystonia through implanted deep brain stimulation electrode

    PubMed Central

    Blomstedt, Patric; Taira, Takaomi; Hariz, Marwan

    2016-01-01

    Background: Some patients with deep brain stimulation (DBS), where removal of implants is indicated due to hardware related infections, are not candidates for later re-implantation. In these patients a rescue lesion through the DBS electrode has been suggested as an option. In this case report we present a patient where a pallidotomy was performed using the DBS electrode. Case Description: An elderly woman with bilateral Gpi DBS suffered an infection around the left burr hole involving the DBS electrode. A unilateral lesion was performed through the DBS electrode before it was removed. No side effects were encountered. Burke-Fahn-Marsden (BFM) dystonia movement scale score was 39 before DBS. With DBS before lesioning BFM score was 2.5 points. The replacement of the left sided stimulation with a pallidotomy resulted in only a minor deterioration of the score to 5 points. Conclusions: In the case presented here a small pallidotomy performed with the DBS electrode provided a satisfactory effect on the patient's dystonic symptoms. Thus, rescue lesions through the DBS electrodes, although off-label, might be considered in patients with Gpi DBS for dystonia when indicated. PMID:27990311

  3. Responses evoked by a vestibular implant providing chronic stimulation.

    PubMed

    Thompson, Lara A; Haburcakova, Csilla; Gong, Wangsong; Lee, Daniel J; Wall, Conrad; Merfeld, Daniel M; Lewis, Richard F

    2012-01-01

    Patients with bilateral vestibular loss experience dehabilitating visual, perceptual, and postural difficulties, and an implantable vestibular prosthesis that could improve these symptoms would be of great benefit to these patients. In previous work, we have shown that a one-dimensional, unilateral canal prosthesis can improve the vestibulooccular reflex (VOR) in canal-plugged squirrel monkeys. In addition to the VOR, the potential effects of a vestibular prosthesis on more complex, highly integrative behaviors, such as the perception of head orientation and posture have remained unclear. We tested a one-dimensional, unilateral prosthesis in a rhesus monkey with bilateral vestibular loss and found that chronic electrical stimulation partially restored the compensatory VOR and also that percepts of head orientation relative to gravity were improved. However, the one-dimensional prosthetic stimulation had no clear effect on postural stability during quiet stance, but sway evoked by head-turns was modestly reduced. These results suggest that not only can the implementation of a vestibular prosthesis provide partial restitution of VOR but may also improve perception and posture in the presence of bilateral vestibular hypofunction (BVH). In this review, we provide an overview of our previous and current work directed towards the eventual clinical implementation of an implantable vestibular prosthesis.

  4. Reconstruction of Mandible: A Fully Digital Workflow From Visualized Iliac Bone Grafting to Implant Restoration.

    PubMed

    Tian, Taoran; Zhang, Tao; Ma, Quanquan; Zhang, Qi; Cai, Xiaoxiao

    2017-07-01

    Although digital aids can help surgeons compensate for the shortcomings of traditional mandibular reconstruction techniques to perform surgery more precisely and effectively, the use of these digital techniques has often been fragmented, divided, and incomplete. This article describes the workflow of a fully digital mandibular reconstruction to explore the proper indications and discusses innovations based on the accuracy and effectiveness of digital techniques. A restoration-oriented mandibular reconstruction was performed by applying different digital techniques. Preoperative virtual surgery and rapid prototyping were used to aid the vascularized iliac bone graft surgery, which offered a solid basis for the ensuing treatment. Subsequently, implant rehabilitation was accomplished with the assistance of computer-assisted design and manufacture, laser treatment, and selective laser melting techniques. The workflow of the fully digital mandibular reconstruction successfully achieved a restoration-oriented treatment. These predictable, accurate, and effective digital techniques improved the consistency of pretreatment design and follow-up treatment. The treatment sequence achieved high predictability and reproducibility owing to the use of digital techniques. This study shows that a digital workflow can be predictable, accurate, and effective, which suggests that it could be a valid digital protocol for developing a treatment sequence for patients with jaw defects caused by trauma, congenital anomalies, or mandibular tumor resection. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  5. Modeling Electrode Place Discrimination in Cochlear Implant Stimulation.

    PubMed

    Gao, Xiao; Grayden, David B; McDonnell, Mark D

    2017-09-01

    By modeling the cochlear implant (CI) electrode-to-nerve interface and quantifying electrode discriminability in the model, we address the questions of how many individual channels can be distinguished by CI recipients and the extent to which performance might be improved by inserting electrodes deeper into the cochlea. We adapt an artificial neural network to model electrode discrimination as well as a commonly used psychophysical measure (four-interval forced-choice) in CI stimulation and predict how well the locations of the stimulating electrodes can be inferred from simulated auditory nerve spiking patterns. We show that a longer electrode leads to better electrode place discrimination in our model. For a simulated four-interval forced-choice procedure, correct classification rates significantly reduce with decreasing distance between the test electrodes and the reference electrodes, and higher correct classification rates may be achieved by the basal electrodes than apical electrodes. Our results suggest that enhanced electrode discriminability results from a longer CI electrode array, and the locations where the errors occur along the electrode array are not only affected by the distance between electrodes but also the twirling angle between electrodes. Our models and simulations provide theoretical insights into several important clinically relevant problems that will inform future designs of CI electrode arrays and stimulation strategies.

  6. Implantable electrical stimulation in high-risk hindfoot fusions.

    PubMed

    Donley, Brian G; Ward, Daniel M

    2002-01-01

    The risk of nonunion in both the ankle and subtalar joints has been reported as high as 41% and 16%, respectively. Several factors have been reported to significantly increase the incidence of nonunion: smoking, previous nonunion, osteonecrosis, history of infection, fracture type, and major medical problems. A single surgeon's experience is retrospectively reviewed. Thirteen patients who were identified as high risk for non-union had an implantable electrical stimulator placed at the time of their ankle or hindfoot fusion along with bone grafting. Three ankle, two subtalar, six tibiotalocalcaneal, and two tibiocalcaneal fusions were performed. All 13 patients had a minimum of two major risk factors for non-union. Of the 13 patients, 11 were active smokers and five of 13 had three or more major risk factors. At a minimum of one year follow-up (average, 24.6 months), successful fusion was achieved in 12 of 13 (92%) patients. Pain scores improved from a mean of 8.5 points preoperatively (range, 7 to 10) to a mean of 1.9 points postoperatively (range, 1 to 6), while the preoperative mean modified AOFAS score of 31.2 points (range, 15 to 55) improved to 85.4 points (range, 45 to 100) postoperatively. The improvement was statistically significant at p<0.01. Eleven of 13 patients (85%) ranked their pain as a 1 or 2 out of 10, and achieved a modified AOFAS score of 80 or better. No additional procedures were done to achieve fusion. Four patients developed superficial wound infections requiring local wound care. The subcutaneous battery pack was bothersome to eight of 13 patients, painful to one, and removed in four patients. The results suggest that electrical implantable stimulation may be a useful adjunct to rigid internal fixation and bone grafting for ankle and hindfoot fusions in high-risk patients.

  7. A Fully Implantable, Programmable and Multimodal Neuroprocessor for Wireless, Cortically Controlled Brain-Machine Interface Applications

    PubMed Central

    Zhang, Fei; Aghagolzadeh, Mehdi; Oweiss, Karim

    2012-01-01

    Reliability, scalability and clinical viability are of utmost importance in the design of wireless Brain Machine Interface systems (BMIs). This paper reports on the design and implementation of a neuroprocessor for conditioning raw extracellular neural signals recorded through microelectrode arrays chronically implanted in the brain of awake behaving rats. The neuroprocessor design exploits a sparse representation of the neural signals to combat the limited wireless telemetry bandwidth. We demonstrate a multimodal processing capability (monitoring, compression, and spike sorting) inherent in the neuroprocessor to support a wide range of scenarios in real experimental conditions. A wireless transmission link with rate-dependent compression strategy is shown to preserve information fidelity in the neural data. At 32 channels, the neuroprocessor has been fully implemented on a 5mm×5mm nano-FPGA, and the prototyping resulted in 5.19 mW power consumption, bringing its performance within the power-size constraints for clinical use. The optimal design for compression and sorting performance was evaluated for multiple sampling frequencies, wavelet basis choice and power consumption. PMID:23050029

  8. A Fully Implantable, Programmable and Multimodal Neuroprocessor for Wireless, Cortically Controlled Brain-Machine Interface Applications.

    PubMed

    Zhang, Fei; Aghagolzadeh, Mehdi; Oweiss, Karim

    2012-12-01

    Reliability, scalability and clinical viability are of utmost importance in the design of wireless Brain Machine Interface systems (BMIs). This paper reports on the design and implementation of a neuroprocessor for conditioning raw extracellular neural signals recorded through microelectrode arrays chronically implanted in the brain of awake behaving rats. The neuroprocessor design exploits a sparse representation of the neural signals to combat the limited wireless telemetry bandwidth. We demonstrate a multimodal processing capability (monitoring, compression, and spike sorting) inherent in the neuroprocessor to support a wide range of scenarios in real experimental conditions. A wireless transmission link with rate-dependent compression strategy is shown to preserve information fidelity in the neural data. At 32 channels, the neuroprocessor has been fully implemented on a 5mm×5mm nano-FPGA, and the prototyping resulted in 5.19 mW power consumption, bringing its performance within the power-size constraints for clinical use. The optimal design for compression and sorting performance was evaluated for multiple sampling frequencies, wavelet basis choice and power consumption.

  9. A high bandwidth fully implantable mouse telemetry system for chronic ECG measurement.

    PubMed

    Russell, David M; McCormick, Daniel; Taberner, Andrew J; Malpas, Simon C; Budgett, David M

    2011-01-01

    We report on the development of a novel system that enables the wireless transmission of high-bandwidth physiological data from a freely moving mouse. The system employs inductive power transfer (IPT) to continuously power a battery-less transmitter using an array of overlapping planar coils placed under the animal. This arrangement provides a minimum of 20 mW at all locations and orientations across the mouse cage by selecting a coil which will sufficiently power the transmitter. Coil selection is performed by feedback control across the 2.4 GHz wireless link. A device was constructed utilizing this novel IPT system and was used to capture high-fidelity electrocardiogram (ECG) signal sampled at 2 kHz in mice. Various attributes of the ECG signal such as QT, QRS, and PR intervals could be obtained with a high degree of accuracy. This system potentially provides lifetime continuous high bandwidth measurement of physiological signals from a fully implanted telemeter in a freely moving mouse.

  10. Assessment of Mechanical Stability and Safety for Fully Edentulous Maxilla with Dental Implants

    NASA Astrophysics Data System (ADS)

    Arahira, Takaaki; Todo, Mitsugu; Matsushita, Yasuyuki; Koyano, Kiyoshi

    A three-dimensional maxillary bone model was constructed using CT-images. The distribution of Young’s modulus was also estimated from the bone mineral density distribution. Four or six implants were embedded into the maxillary model and a metal prosthesis was attached to the implants. Computational analysis of the maxilla model was performed in order to characterize effects of the number of embedded implants on the stress state of the maxilla under two different loading conditions. For the two loading conditions, the distribution of strain energy density was severely concentrated especially around the right-molar implant, suggesting bone damage and absorption in this region. The 4-implants model with rear implantation and shortened prosthesis showed almost the same value of strain energy density in the 6-implants model. It is thus concluded that this kind of 3-D modeling could clinically be used for predicting the optimal position of implantation corresponding to each patient.

  11. Research Progress of Subretinal Implant based on Electronic Stimulation.

    PubMed

    Xing, Wang; Chenglin, Peng; Zhiqiang, Zhao; Xiaogang, Luo; Ning, Hu; Huiquan, Zhang

    2005-01-01

    Subretinal prosthesis is one kind of retinal prosthesis, which means that a microimplant based on MEMS technology is inserted in the subretinal space to stimulate the optic nerve and elicit an electrical-evoked response on the cortical region. The subretinal implant is made up of extraocular part and intraocular part. As an important part, the latter consists of accessorial setting and stimulation chip that contains microphotodiode array (MPDA) and microelectrodes. The paper main body is made up of four parts. Firstly significance of the retinal prosthesis is given out;secondly fundamentals on both in retina physiology and retinal prosthesis theory are introduced simply. Then the key segment about the subretinal microimplant is presented in detail. In the third segment, first of all is its design concept, the second is fabrication of MPDA which consists of several parts. First is microscopic configuration, electric prototype schematic and chip image COMS. The second is detailed fabrication flow with several special materials. Then is situation of its dimension. The fourth segment presents challenge and outlook.

  12. [Research progress of subretinal implant based on electronic stimulation].

    PubMed

    Wang, Xing; Peng, Chenglin; Zhang, Ying; Zhang, Sijie; Hu, Ning; Yang, Lili; Zheng, Erxin

    2008-02-01

    Subretinal prosthesis is one kind of retinal prosthesis, which means that a microimplant based on MEMS technology is inserted in the subretinal space to stimulate the optic nerve and elicit an electrical-evoked response on the cortical region. The subretinal implant is made up of extraocular part and intraocular part. As an important part, the latter consists of accessorial setting and stimulation chip that contains microphotodiode array (MPDA) and microelectrodes. The paper main body is made up of four parts. Firstly significance of the retinal prosthesis is given out; secondly fundamentals on both in retina physiology and retinal prosthesis theory are introduced simply. Then the key segment about the subretinal microimplant is presented in detail. In the third segment, first of all is its design concept, the second is fabrication of MPDA which consists of several parts. First is microscopic configuration, electric prototype schematic and chip image CMOS. The second is detailed fabrication flow with several special materials. Then is situation of its dimension. The fourth segment presents challenge and outlook.

  13. A Retrospective Multicentre Cohort Review of Patient Characteristics and Surgical Aspects versus the Long-Term Outcomes for Recipients of a Fully Implantable Active Middle Ear Implant

    PubMed Central

    Lefebvre, Philippe P.; Gisbert, Javier; Cuda, Domenico; Tringali, Stéphane; Deveze, Arnaud

    2017-01-01

    Objective To summarise treatment outcomes compared to surgical and patient variables for a multicentre recipient cohort using a fully implantable active middle ear implant for hearing impairment. To describe the authors' preferred surgical technique to determine microphone placement. Study Design Multicentre retrospective, observational survey. Setting Five tertiary referral centres. Patients Carina recipients (66 ears, 62 subjects) using the current Cochlear® Carina® System or the legacy device, the Otologics® Fully Implantable Middle Ear, with a T2 transducer. Methods Patient file review and routine clinical review. Patient outcomes assessed were satisfaction, daily use and feedback reports at the first fitting and ≥12 months after implantation. Descriptive and statistical analysis of correlations of variables and their influence on outcomes was performed. Independently reported preferred methods for microphone placement are collectively summarised. Results The average implant experience was 3.5 years. Satisfaction increased significantly over time (p < 0.05). No correlation with covariates examined was observed. Feedback significantly decreased over time, showing a significant correlation with microphone location, primary motivation, gender, age at implantation, and contralateral hearing aid use (p < 0.05). Patient satisfaction was inversely correlated with reports of system feedback (p < 0.05). The implantable microphone was most commonly on the posterior inferior mastoid line, in 42/66 (65%) cases, correlating with less likelihood for feedback and consistent with author surgical preference. Conclusion Carina recipients in this study present as satisfied consistent daily users with very few reports of persistent feedback. As microphone location is an influencing factor, a careful surgical consideration of microphone placement is required. The authors prefer a posterior inferior mastoid line position whenever possible. PMID:28052264

  14. Use of brain MRI after deep brain stimulation hardware implantation.

    PubMed

    Nazzaro, Jules M; Lyons, Kelly E; Wetzel, Louis H; Pahwa, Rajesh

    2010-03-01

    The objective of this study was to examine the experience with and safety of brain 1.5 Tesla (T) magnetic resonance imaging (MRI) in deep brain stimulation (DBS) patients. This was a retrospective review of brain MRI scanning performed on DBS patients at the University of Kansas Medical Center between January 1995 and December 2007. A total of 249 DBS patients underwent 445 brain 1.5 T MRI scan sessions encompassing 1,092 individual scans using a transmit-receive head coil, representing the cumulative scanning of 1,649 DBS leads. Patients with complete implanted DBS systems as well as those with externalized leads underwent brain imaging. For the majority of scans, specific absorption rates localized to the head (SAR(H)) were estimated and in all cases SAR(H) were higher than that specified in the present product labeling. There were no clinical or hardware related adverse events secondary to brain MRI scanning. Our data should not be extrapolated to encourage MRI scanning beyond the present labeling. Rather, our data may contribute to further defining safe MRI scanning parameters that might ultimately be adopted in future product labeling as more centers report in detail their experiences.

  15. Deep brain stimulation with a pre-existing cochlear implant: Surgical technique and outcome

    PubMed Central

    Eddelman, Daniel; Wewel, Joshua; Wiet, R. Mark; Metman, Leo V.; Sani, Sepehr

    2017-01-01

    Background: Patients with previously implanted cranial devices pose a special challenge in deep brain stimulation (DBS) surgery. We report the implantation of bilateral DBS leads in a patient with a cochlear implant. Technical nuances and long-term interdevice functionality are presented. Case Description: A 70-year-old patient with advancing Parkinson's disease and a previously placed cochlear implant for sensorineural hearing loss was referred for placement of bilateral DBS in the subthalamic nucleus (STN). Prior to DBS, the patient underwent surgical removal of the subgaleal cochlear magnet, followed by stereotactic MRI, frame placement, stereotactic computed tomography (CT), and merging of imaging studies. This technique allowed for successful computational merging, MRI-guided targeting, and lead implantation with acceptable accuracy. Formal testing and programming of both the devices were successful without electrical interference. Conclusion: Successful DBS implantation with high resolution MRI-guided targeting is technically feasible in patients with previously implanted cochlear implants by following proper precautions. PMID:28480109

  16. Deep brain stimulation with a pre-existing cochlear implant: Surgical technique and outcome.

    PubMed

    Eddelman, Daniel; Wewel, Joshua; Wiet, R Mark; Metman, Leo V; Sani, Sepehr

    2017-01-01

    Patients with previously implanted cranial devices pose a special challenge in deep brain stimulation (DBS) surgery. We report the implantation of bilateral DBS leads in a patient with a cochlear implant. Technical nuances and long-term interdevice functionality are presented. A 70-year-old patient with advancing Parkinson's disease and a previously placed cochlear implant for sensorineural hearing loss was referred for placement of bilateral DBS in the subthalamic nucleus (STN). Prior to DBS, the patient underwent surgical removal of the subgaleal cochlear magnet, followed by stereotactic MRI, frame placement, stereotactic computed tomography (CT), and merging of imaging studies. This technique allowed for successful computational merging, MRI-guided targeting, and lead implantation with acceptable accuracy. Formal testing and programming of both the devices were successful without electrical interference. Successful DBS implantation with high resolution MRI-guided targeting is technically feasible in patients with previously implanted cochlear implants by following proper precautions.

  17. A reliable method for intracranial electrode implantation and chronic electrical stimulation in the mouse brain.

    PubMed

    Jeffrey, Melanie; Lang, Min; Gane, Jonathan; Wu, Chiping; Burnham, W McIntyre; Zhang, Liang

    2013-08-06

    Electrical stimulation of brain structures has been widely used in rodent models for kindling or modeling deep brain stimulation used clinically. This requires surgical implantation of intracranial electrodes and subsequent chronic stimulation in individual animals for several weeks. Anchoring screws and dental acrylic have long been used to secure implanted intracranial electrodes in rats. However, such an approach is limited when carried out in mouse models as the thin mouse skull may not be strong enough to accommodate the anchoring screws. We describe here a screw-free, glue-based method for implanting bipolar stimulating electrodes in the mouse brain and validate this method in a mouse model of hippocampal electrical kindling. Male C57 black mice (initial ages of 6-8 months) were used in the present experiments. Bipolar electrodes were implanted bilaterally in the hippocampal CA3 area for electrical stimulation and electroencephalographic recordings. The electrodes were secured onto the skull via glue and dental acrylic but without anchoring screws. A daily stimulation protocol was used to induce electrographic discharges and motor seizures. The locations of implanted electrodes were verified by hippocampal electrographic activities and later histological assessments. Using the glue-based implantation method, we implanted bilateral bipolar electrodes in 25 mice. Electrographic discharges and motor seizures were successfully induced via hippocampal electrical kindling. Importantly, no animal encountered infection in the implanted area or a loss of implanted electrodes after 4-6 months of repetitive stimulation/recording. We suggest that the glue-based, screw-free method is reliable for chronic brain stimulation and high-quality electroencephalographic recordings in mice. The technical aspects described this study may help future studies in mouse models.

  18. A reliable method for intracranial electrode implantation and chronic electrical stimulation in the mouse brain

    PubMed Central

    2013-01-01

    Background Electrical stimulation of brain structures has been widely used in rodent models for kindling or modeling deep brain stimulation used clinically. This requires surgical implantation of intracranial electrodes and subsequent chronic stimulation in individual animals for several weeks. Anchoring screws and dental acrylic have long been used to secure implanted intracranial electrodes in rats. However, such an approach is limited when carried out in mouse models as the thin mouse skull may not be strong enough to accommodate the anchoring screws. We describe here a screw-free, glue-based method for implanting bipolar stimulating electrodes in the mouse brain and validate this method in a mouse model of hippocampal electrical kindling. Methods Male C57 black mice (initial ages of 6–8 months) were used in the present experiments. Bipolar electrodes were implanted bilaterally in the hippocampal CA3 area for electrical stimulation and electroencephalographic recordings. The electrodes were secured onto the skull via glue and dental acrylic but without anchoring screws. A daily stimulation protocol was used to induce electrographic discharges and motor seizures. The locations of implanted electrodes were verified by hippocampal electrographic activities and later histological assessments. Results Using the glue-based implantation method, we implanted bilateral bipolar electrodes in 25 mice. Electrographic discharges and motor seizures were successfully induced via hippocampal electrical kindling. Importantly, no animal encountered infection in the implanted area or a loss of implanted electrodes after 4–6 months of repetitive stimulation/recording. Conclusion We suggest that the glue-based, screw-free method is reliable for chronic brain stimulation and high-quality electroencephalographic recordings in mice. The technical aspects described this study may help future studies in mouse models. PMID:23914984

  19. Effects of stimulation rates on Cantonese lexical tone perception by cochlear implant users in Hong Kong.

    PubMed

    Au, D K K

    2003-12-01

    High, moderate and low stimulation rates of 1800, 800 and 400 pulse per second (pps)/channel, respectively, were used to test the effects of stimulation rates on the discrimination and identification of Cantonese lexical tones in 11 Chinese post-lingually deafened adults with cochlear implants (CIs). The subjects were implanted with the MED-EL Combi 40+ CI system. They were randomly assigned to each of the stimulation rate conditions according to an ABC design. In both the Cantonese lexical tone perception tests, the subjects reached the highest scores in the high-stimulation-rate condition, and the lowest scores in the low-stimulation-rate condition (P < 0.01). Post hoc comparisons between different stimulation rates did not yield consistent results. This study demonstrated that the maximum stimulation rate of 1800 pps/channel could be an 'optimal' stimulation rate and an informed choice of parameter for the benefit of Cantonese-speaking CI users in lexical tone perception.

  20. Management of a fully edentulous mandible using an implant supported overdenture: a case report.

    PubMed

    Egesi, Edward; Uguru, Chibuzo

    2015-01-01

    The choice for rehabilitation of an edentulous mandible by an implant supported overdenture is now the recommended minimally accepted option. This prosthesis has many advantages over conventional dentures and root or tooth supported overdentuers. We present a case of a failed conventional long span bridge which was treated satisfactorily using a four implant supported over denture and discuss our treatment option along with its advantages. This is a new and developing treatment option in our country.

  1. Prevention of mechanical failures in implanted spinal cord stimulation systems.

    PubMed

    Henderson, Jaimie M; Schade, C M; Sasaki, John; Caraway, David L; Oakley, John C

    2006-07-01

    Introduction.  Spinal cord stimulation (SCS) is an effective procedure for the treatment of neuropathic extremity pain, with success rates approaching 70%. However, mechanical failures, including breakage and migration, can significantly limit the long-term effectiveness of SCS. A systematic analysis of surgical techniques was undertaken by a consensus group, coupled with extensive in vivo and in vitro biomechanical testing of system components. Methods.  A computer model based on morphometric data was used to predict movement in a standard SCS system between an anchored lead and pulse generator placed in various locations. These displacements were then used to determine a realistic range of forces exerted on components of the SCS system. Laboratory fixtures were constructed to subject leads and anchors to repetitive stresses until failure occurred. An in vivo sheep model also was used to determine system compliances and failure thresholds in a biologically realistic setting. A panel of experienced implanters then interpreted the results and related them to clinical observations. Results.  Use of a soft silastic anchor pushed through the fascia to provide a larger bend radius for the lead was associated with a time to failure 65 times longer than an anchored but unsupported lead. In addition, failures of surgical paddle leads occurred when used with an anchor, whereas without an anchor, no failures occurred to 1 million cycles. Based on these findings, the panel recommended a paramedian approach, abdominal pulse generator placement, maximizing bend radius by pushing the anchor through the fascia, and anchoring of the extension connector near the lead anchor. Discussion.  Several factors are important in longevity of SCS systems. We discovered that technical factors can make a large difference in SCS reliability and that strict attention to these "best practices" will provide the best chance for maintaining the integrity of SCS systems over the long term.

  2. Radiofrequency energy ablation in a child with an implanted vagus nerve stimulator.

    PubMed

    Radolec, Mackenzy M; Beerman, Lee B; Arora, Gaurav

    2015-10-01

    An 8-year-old girl with supraventricular tachycardia and an implanted vagus nerve stimulator underwent radiofrequency ablation of her supraventricular tachycardia substrate. No known literature exists addressing the potential interaction of these two technologies, although there are reported cases of interaction between radiofrequency and other implanted stimulating devices such as pacemakers. The procedure was performed successfully without observed interaction, and the patient's family reported no significant change in frequency of seizure control.

  3. A fully integrated wireless system for intracranial direct cortical stimulation, real-time electrocorticography data transmission, and smart cage for wireless battery recharge.

    PubMed

    Piangerelli, Marco; Ciavarro, Marco; Paris, Antonino; Marchetti, Stefano; Cristiani, Paolo; Puttilli, Cosimo; Torres, Napoleon; Benabid, Alim Louis; Romanelli, Pantaleo

    2014-01-01

    Wireless transmission of cortical signals is an essential step to improve the safety of epilepsy procedures requiring seizure focus localization and to provide chronic recording of brain activity for Brain Computer Interface (BCI) applications. Our group developed a fully implantable and externally rechargeable device, able to provide wireless electrocorticographic (ECoG) recording and cortical stimulation (CS). The first prototype of a wireless multi-channel very low power ECoG system was custom-designed to be implanted on non-human primates. The device, named ECOGIW-16E, is housed in a compact hermetically sealed Polyether ether ketone (PEEK) enclosure, allowing seamless battery recharge. ECOGIW-16E is recharged in a wireless fashion using a special cage designed to facilitate the recharge process in monkeys and developed in accordance with guidelines for accommodation of animals by Council of Europe (ETS123). The inductively recharging cage is made up of nylon and provides a thoroughly novel experimental setting on freely moving animals. The combination of wireless cable-free ECoG and external seamless battery recharge solves the problems and shortcomings caused by the presence of cables leaving the skull, providing a safer and easier way to monitor patients and to perform ECoG recording on primates. Data transmission exploits the newly available Medical Implant Communication Service band (MICS): 402-405 MHz. ECOGIW-16E was implanted over the left sensorimotor cortex of a macaca fascicularis to assess the feasibility of wireless ECoG monitoring and brain mapping through CS. With this device, we were able to record the everyday life ECoG signal from a monkey and to deliver focal brain stimulation with movement elicitation.

  4. Prospective clinical study of a new implantable peripheral nerve stimulation device to treat chronic pain.

    PubMed

    Deer, Timothy R; Levy, Robert M; Rosenfeld, Evan L

    2010-06-01

    To evaluate clinical use of the StimRouter, an investigational implanted peripheral nerve stimulator for treating chronic neuropathic pain, using the median nerve as a model for that general application. Eight patients with carpal tunnel syndrome and chronic pain despite both carpal tunnel release and treatment with oral pain medications were enrolled in a single-center, open-label trial after institutional review board approval. Primary endpoints were successful implantation near the target peripheral nerve and safety. All 8 patients were implanted temporarily at the median nerve in at least one arm and 2 patients were implanted bilaterally, with 10 implants total. Each implant was considered a separate "patient." For 5 days, all patients received 6 hours of daily transdermal electrical stimulation targeting the median nerve. Pain was measured at baseline, during implant, and after explant. Two patients experienced clinically meaningful (>or=30%) pain reduction throughout the entire 5-day treatment period. Apparent carryover effect in pain reduction also was observed after daily stimulation. After explant, pain returned to baseline, increasing 36.8% to 45.6% relative to average reduced pain with daily stimulation. No significant or unexpected adverse events occurred. Mean patient study satisfaction was 96%, and 100% of patients indicated a preference for permanent implant. Temporary implant of the StimRouter device resulted in both pain reduction and reduced use of oral opioid pain medication during the 5-day stimulation period. The results suggest that permanent implant of the StimRouter System may be safe and effective for treating chronic peripheral neuropathic pain.

  5. [Anterior and posterior medullary analgesic stimulation, using a percutaneous implantation technic].

    PubMed

    Lazorthes, Y; Verdie, J C; Arbus, L

    1978-01-01

    The technique of percutaneous implantation of a pain-relieving stimulator reduces the surgical procedure considerably. This advantage is, however, lessened by the absence of precision in placing epidural electrodes, and by the risk of their later displacement leading to inadequate stimulation. To reduce this disadvantage the authors suggest a technique that is a modification of the classical open procedure: it is particularly suitable for implantation at the cervico-dorsal junction. In 12 patients treated by percutaneous implantation, 5 received, from epidural electrodes, an anterior medullary electrical stimulation which caused analgesia without paraesthesiae in the painful ares. The results, however, do not justify a conclusion that anterior medullary stimulation is better than posterior column stimulation.

  6. [Ocular electrical stimulation: Therapeutic application and active retinal implants for hereditary retinal degenerations].

    PubMed

    Gekeler, F; Zrenner, E; Bartz-Schmidt, K U

    2015-09-01

    Electrical stimulation has a long history in ophthalmology. Subthreshold electrical stimulation can have beneficial therapeutic effects on hereditary degenerative retinal diseases. Suprathreshold stimulation is able to elicit visual perceptions and, if multielectrode fields are arranged as an array, usable pictures can be perceived by blind patients. This is a review article on the current situation and studies on therapeutic transcorneal electrical stimulation. Moreover, the challenges, surgical concepts and visual results of active retinal implants are discussed. This article gives an overview on transcorneal electrical stimulation and active retinal implants based on published results, with special emphasis on the clinical application. The results of initial controlled studies on therapeutic transcorneal electrical stimulation in hereditary retinal diseases were very promising. The largest controlled study so far in patients with retinitis pigmentosa (RP) has yielded many positive trends and some significant improvements in electrophysiological data. Currently, two retinal implants have regulatory approval, the Argus II retinal prosthesis system® (SecondSight®) and the Alpha-IMS© (Retina Implant AG). Both systems can be used to improve visual perception and under test conditions can achieve visual acuities of 0.02 and 0.04, respectively. In-depth analyses and follow-up studies in larger patient groups are currently planned to definitively clarify the potential of therapeutic transcorneal electrical stimulation in RP patients. The challenges of currently available active retinal implants are the technical biostability and the limited spatial resolution.

  7. A PARYLENE-BASED MICROELECTRODE ARRAY IMPLANT FOR SPINAL CORD STIMULATION IN RATS

    PubMed Central

    Nandra, Mandheerej. S.; Lavrov, Igor A.; Edgerton, V. Reggie; Tai, Yu-Chong

    2011-01-01

    The design and fabrication of an epidural spinal cord implant using a parylene-based microelectrode array is presented. Rats with hindlimb paralysis from a complete spinal cord transection were implanted with the device and studied for up to eight weeks, where we have demonstrated recovery of hindlimb stepping functionality through pulsed stimulation. The microelectrode array allows for a high degree of freedom and specificity in selecting the site of stimulation compared to wire-based implants, and triggers varied biological responses that can lead to an increased understanding of the spinal cord and locomotion recovery for victims of spinal cord injury. PMID:21841938

  8. A PARYLENE-BASED MICROELECTRODE ARRAY IMPLANT FOR SPINAL CORD STIMULATION IN RATS.

    PubMed

    Nandra, Mandheerej S; Lavrov, Igor A; Edgerton, V Reggie; Tai, Yu-Chong

    2011-01-23

    The design and fabrication of an epidural spinal cord implant using a parylene-based microelectrode array is presented. Rats with hindlimb paralysis from a complete spinal cord transection were implanted with the device and studied for up to eight weeks, where we have demonstrated recovery of hindlimb stepping functionality through pulsed stimulation. The microelectrode array allows for a high degree of freedom and specificity in selecting the site of stimulation compared to wire-based implants, and triggers varied biological responses that can lead to an increased understanding of the spinal cord and locomotion recovery for victims of spinal cord injury.

  9. Melatonin plus porcine bone on discrete calcium deposit implant surface stimulates osteointegration in dental implants.

    PubMed

    Calvo-Guirado, José Luis; Gómez-Moreno, Gerardo; Barone, Antonio; Cutando, Antonio; Alcaraz-Baños, Miguel; Chiva, Fernando; López-Marí, Laura; Guardia, Javier

    2009-09-01

    The aim of this study was to evaluate the effect of the topical application of melatonin mixed with collagenized porcine bone to accelerate the osteointegration on the rough discrete calcium deposit (DCD) surface implants in Beagle dogs 3 months after their insertion. In preparation for subsequent insertion of dental implants, lower premolars and molars were extracted from 12 Beagle dogs. Each mandible received three parallel wall implants with discrete calcium deposit (DCD) surface of 4 mm in diameter and 10 mm in length. The implants were randomly assigned to the distal sites on each side of the mandible in three groups: group I implants alone, group II implants with melatonin and group III implants with melatonin and porcine bone. Prior to implanting, 5 mg lyophylized powdered melatonin was applied to one bone hole at each side of the mandible. None was applied at the control sites. Ten histological sections per implant were obtained for histomorphometric studies. After a 4-wk treatment period, melatonin significantly increased the perimeter of bone that was in direct contact with the treated implants (P < 0.0001), bone density (P < 0.0001), new bone formation (P < 0.0001) in comparison with control implants. Topical application of melatonin on DCD surface may act as a biomimetic agent in the placement of endo-osseous dental implants and enhance the osteointegration. Melatonin combined with porcine bone on DCD implants reveals more bone to implant contact at 12 wk (84.5 +/- 1.5%) compared with melatonin treated (75.1 +/- 1.4%) and nonmelatonin treated surface implants (64 +/- 1.4%).

  10. CUSTOM-FIT RADIOLUCENT CRANIAL IMPLANTS FOR NEUROPHYSIOLOGICAL RECORDING AND STIMULATION

    PubMed Central

    Mulliken, Grant H; Bichot, Narcisse P; Ghadooshahy, Azriel; Sharma, Jitendra; Kornblith, Simon; Philcock, Michael; Desimone, Robert

    2015-01-01

    Background Recording and manipulating neural activity in awake behaving animal models requires long-term implantation of cranial implants that must address a variety of design considerations, which include preventing infection, minimizing tissue damage, mechanical strength of the implant, and MRI compatibility. New Method Here we address these issues by designing legless, custom-fit cranial implants using structural MRI-based reconstruction of the skull and that are made from carbon-reinforced PEEK. Results We report several novel custom-fit radiolucent implant designs, which include a legless recording chamber, a legless stimulation chamber, a multi-channel microdrive and a head post. The fit to the skull was excellent in all cases, with no visible gaps between the base of the implants and the skull. The wound margin was minimal in size and showed no sign of infection or skin recession. Comparison with Existing Methods Cranial implants used for neurophysiological investigation in awake behaving animals often employ methyl methacrylate (MMA) to serve as a bonding agent to secure the implant to the skull. Other designs rely on radially extending legs to secure the implant. Both of these methods have significant drawbacks. MMA is toxic to bone and frequently leads to infection while radially extending legs cause the skin to recede away from the implant, ultimately exposing bone and proliferating granulation tissue. Conclusions These radiolucent implants constitute a set of technologies suitable for reliable long-term recording, which minimize infection and tissue damage. PMID:25542350

  11. Vestibular implantation and longitudinal electrical stimulation of the semicircular canal afferents in human subjects

    PubMed Central

    Ling, Leo; Nie, Kaibao; Jameyson, Elyse; Phillips, Christopher M.; Nowack, Amy L.; Golub, Justin S.; Rubinstein, Jay T.

    2015-01-01

    Animal experiments and limited data in humans suggest that electrical stimulation of the vestibular end organs could be used to treat loss of vestibular function. In this paper we demonstrate that canal-specific two-dimensionally (2D) measured eye velocities are elicited from intermittent brief 2 s biphasic pulse electrical stimulation in four human subjects implanted with a vestibular prosthesis. The 2D measured direction of the slow phase eye movements changed with the canal stimulated. Increasing pulse current over a 0–400 μA range typically produced a monotonic increase in slow phase eye velocity. The responses decremented or in some cases fluctuated over time in most implanted canals but could be partially restored by changing the return path of the stimulation current. Implantation of the device in Meniere's patients produced hearing and vestibular loss in the implanted ear. Electrical stimulation was well tolerated, producing no sensation of pain, nausea, or auditory percept with stimulation that elicited robust eye movements. There were changes in slow phase eye velocity with current and over time, and changes in electrically evoked compound action potentials produced by stimulation and recorded with the implanted device. Perceived rotation in subjects was consistent with the slow phase eye movements in direction and scaled with stimulation current in magnitude. These results suggest that electrical stimulation of the vestibular end organ in human subjects provided controlled vestibular inputs over time, but in Meniere's patients this apparently came at the cost of hearing and vestibular function in the implanted ear. PMID:25652917

  12. Pulse-Width Modulation of Optogenetic Photo-Stimulation Intensity for Application to Full-Implantable Light Sources.

    PubMed

    Chen, Fu-Yu Beverly; Budgett, David M; Sun, Yuhui; Malpas, Simon; McCormick, Daniel; Freestone, Peter S

    2017-02-01

    Optogenetics allows control of neuronal activity with unprecedented spatiotemporal precision, and has enabled both significant advances in neuroscience and promising clinical prospects for some neurological, cardiac, and sensory disorders. The ability to chronically stimulate light-sensitive excitable cells is crucial for developing useful research tools and viable long-term treatment strategies. Popular optogenetic stimulation devices often rely on bench-top light-sources tethered via an optical fibre to the research animal, or significant componentry protruding externally from animal. These approaches are prone to infection, vulnerable to damage and restrict the experimental approaches that can be conducted. An ideal optogenetic stimulator would be contained entirely within the animal and provide precisely controlled optical output. However, existing prototypes of fully implantable devices rely on amplitude tuning of wireless power, which can vary strongly with environmental conditions. Here we show that pulse-width modulation (PWM) of the intensity of a light-emitting diode (LED) can enable control of photo-stimulation intensity equivalent to direct amplitude modulation. This result has significant implications for fully implantable light delivery tools, as PWM can be implemented with simple and miniaturized circuit architectures. We have modified a telemeter device previously developed by our group to include a small form-factor LED capable of generating sufficient optical power with manageable electrical power requirements and minimal heat generation. We have tested key device components in an in vitro mouse brain slice preparation and shown that pulse-width-modulation is an alternative method to modulate photo-stimulation intensity using a miniature circuit and providing easy control.

  13. Battery-powered implantable nerve stimulator for chronic activation of two skeletal muscles using multichannel techniques.

    PubMed

    Lanmüller, H; Sauermann, S; Unger, E; Schnetz, G; Mayr, W; Bijak, M; Rafolt, D; Girsch, W

    1999-05-01

    Chronic activation of skeletal muscle is used clinically in representative numbers for diaphragm pacing to restore breathing and for dynamic graciloplasty to achieve fecal continence. The 3 different stimulation techniques currently used for electrophrenic respiration (EPR) all apply high frequency powered implants. It was our goal to make these stimulation methods applicable for EPR by a battery-powered nerve stimulator that would maximize the patient's freedom of movement. Additionally, the system should allow the implementation of multichannel techniques and alternating stimulation of 2 skeletal muscles as a further improvement in graciloplasty. Generally, the developed implantable nerve stimulator can be used for simultaneous and alternating activation of 2 skeletal muscles. Stimulation of the motor nerve is achieved by either single channel or multichannel methods. Carousel stimulation and sequential stimulation can be used for graciloplasty as well as for EPR. For EPR we calculated an operating time of the implant battery of 4.1 years based on the clinically used stimulation parameters with carousel stimulation. The multichannel pulse generator is hermetically sealed in a titanium case sized 65 x 17 mm (diameter x height) and weighs 88 g.

  14. In vivo stimulation of bone formation by aluminum and oxygen plasma surface-modified magnesium implants.

    PubMed

    Wong, Hoi Man; Zhao, Ying; Tam, Vivian; Wu, Shuilin; Chu, Paul K; Zheng, Yufeng; To, Michael Kai Tsun; Leung, Frankie K L; Luk, Keith D K; Cheung, Kenneth M C; Yeung, Kelvin W K

    2013-12-01

    A newly developed magnesium implant is used to stimulate bone formation in vivo. The magnesium implant after undergoing dual aluminum and oxygen plasma implantation is able to suppress rapid corrosion, leaching of magnesium ions, as well as hydrogen gas release from the biodegradable alloy in simulated body fluid (SBF). No released aluminum is detected from the SBF extract and enhanced corrosion resistance properties are confirmed by electrochemical tests. In vitro studies reveal enhanced growth of GFP mouse osteoblasts on the aluminum oxide coated sample, but not on the untreated sample. In addition to that a small amount (50 ppm) of magnesium ions can enhance osteogenic differentiation as reported previously, our present data show a low concentration of hydrogen can give rise to the same effect. To compare the bone volume change between the plasma-treated magnesium implant and untreated control, micro-computed tomography is performed and the plasma-treated implant is found to induce significant new bone formation adjacent to the implant from day 1 until the end of the animal study. On the contrary, bone loss is observed during the first week post-operation from the untreated magnesium sample. Owing to the protection offered by the Al2O3 layer, the plasma-treated implant degrades more slowly and the small amount of released magnesium ions stimulate new bone formation locally as revealed by histological analyses. Scanning electron microscopy discloses that the Al2O3 layer at the bone-implant interface is still present two months after implantation. In addition, no inflammation or tissue necrosis is observed from both treated and untreated implants. These promising results suggest that the plasma-treated magnesium implant can stimulate bone formation in vivo in a minimal invasive way and without causing post-operative complications.

  15. Effects of Vestibular Prosthesis Electrode Implantation and Stimulation on Hearing in Rhesus Monkeys

    PubMed Central

    Dai, Chenkai; Fridman, Gene Y.; Della Santina, Charles C.

    2011-01-01

    To investigate the effects of vestibular prosthesis electrode implantation and activation on hearing in rhesus monkeys, we measured auditory brainstem responses (ABR) and distortion product otoacoustic emissions (DPOAE) in four rhesus monkeys before and after unilateral implantation of vestibular prosthesis electrodes in each of 3 left semicircular canals (SCC). Each of the 3 left SCCs were implanted with electrodes via a transmastoid approach. Right ears, which served as controls, were not surgically manipulated. Hearing tests were conducted before implantation (BI) and then 4 weeks post implantation both without electrical stimulation (NS) and with electrical stimulation (S). During the latter condition, prosthetic electrical stimuli encoding 3 dimensions of head angular velocity were delivered to the 3 ampullary branches of the left vestibular nerve via each of 3 electrode pairs of a multichannel vestibular prosthesis. Electrical stimuli comprised charge-balanced biphasic pulses at a baseline rate of 94 pulses/sec, with pulse frequency modulated from 48–222 pulses/s by head angular velocity. ABR hearing thresholds to clicks and tone pips at 1, 2, and 4 kHz increased by 5–10 dB from BI to NS and increased another ~5 dB from NS to S in implanted ears. No significant change was seen in right ears. DPOAE amplitudes decreased by 2–14 dB from BI to NS in implanted ears. There was a slight but insignificant decrease of DPOAE amplitude and a corresponding increase of DPOAE/Noise floor ratio between NS and S in implanted ears. Vestibular prosthesis electrode implantation and activation have small but measurable effects on hearing in rhesus monkeys. Coupled with the clinical observation that patients with cochlear implants only rarely exhibit signs of vestibular injury or spurious vestibular nerve stimulation, these results suggest that although implantation and activation of multichannel vestibular prosthesis electrodes in human will carry a risk of hearing loss

  16. Evaluation of focused multipolar stimulation for cochlear implants: a preclinical safety study

    NASA Astrophysics Data System (ADS)

    Shepherd, Robert K.; Wise, Andrew K.; Enke, Ya Lang; Carter, Paul M.; Fallon, James B.

    2017-08-01

    Objective. Cochlear implants (CIs) have a limited number of independent stimulation channels due to the highly conductive nature of the fluid-filled cochlea. Attempts to develop highly focused stimulation to improve speech perception in CI users includes the use of simultaneous stimulation via multiple current sources. Focused multipolar (FMP) stimulation is an example of this approach and has been shown to reduce interaction between stimulating channels. However, compared with conventional biphasic current pulses generated from a single current source, FMP is a complex stimulus that includes extended periods of stimulation before charge recovery is achieved, raising questions on whether chronic stimulation with this strategy is safe. The present study evaluated the long-term safety of intracochlear stimulation using FMP in a preclinical animal model of profound deafness. Approach. Six cats were bilaterally implanted with scala tympani electrode arrays two months after deafening, and received continuous unilateral FMP stimulation at levels that evoked a behavioural response for periods of up to 182 d. Electrode impedance, electrically-evoked compound action potentials (ECAPs) and auditory brainstem responses (EABRs) were monitored periodically over the course of the stimulation program from both the stimulated and contralateral control cochleae. On completion of the stimulation program cochleae were examined histologically and the electrode arrays were evaluated for evidence of platinum (Pt) corrosion. Main results. There was no significant difference in electrode impedance between control and chronically stimulated electrodes following long-term FMP stimulation. Moreover, there was no significant difference between ECAP and EABR thresholds evoked from control or stimulated cochleae at either the onset of stimulation or at completion of the stimulation program. Chronic FMP stimulation had no effect on spiral ganglion neuron (SGN) survival when compared with

  17. 10-year survival rate and the incidence of peri-implant disease of 374 titanium dental implants with a SLA surface: a prospective cohort study in 177 fully and partially edentulous patients.

    PubMed

    van Velzen, Frank J J; Ofec, Ronen; Schulten, Engelbert A J M; Ten Bruggenkate, Christiaan M

    2015-10-01

    This prospective cohort study evaluates the 10-year survival and incidence of peri-implant disease at implant and patient level of sandblasted, large grid, and acid-etched titanium dental implants (Straumann, soft tissue level, SLA surface) in fully and partially edentulous patients. Patients who had dental implant surgery in the period between November 1997 and June 2001, with a follow-up of at least 10 years, were investigated for clinical and radiological examination. Among the 506 inserted dental implants in 250 patients, 10-year data regarding the outcome of implants were available for 374 dental implants in 177 patients. In the current study, peri-implantitis was defined as advanced bone loss (≧1.5 mm. postloading) in combination with bleeding on probing. At 10-year follow-up, only one implant was lost (0.3%) 2 months after implant surgery due to insufficient osseointegration. The average bone loss at 10 year postloading was 0.52 mm. Advanced bone loss at 10-year follow-up was present in 35 dental implants (9.8%). Seven percent of the observed dental implants showed bleeding on probing in combination with advanced bone loss and 4.2% when setting the threshold for advanced bone loss at 2.0 mm. Advanced bone loss without bleeding on probing was present in 2.8% of all implants. In this prospective study, the 10-year survival rate at implant and patient level was 99.7% and 99.4%, respectively. Peri-implantitis was present in 7% of the observed dental implants according to the above-mentioned definition of peri-implantitis. This study shows that SLA implants offer predictable long-term results as support in the treatment of fully and partially edentulous patients. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Efficacy Study of a Fully Implanted Neuroprosthesis for Functional Benefit to Individuals with Tetraplegia

    DTIC Science & Technology

    2015-10-01

    function for individuals with cervical SCI . This study will utilize the “networked neuroprosthesis” (NNP). The NNP system is completely implanted...dissemination of advanced neuroprosthetic systems for the provision of motor function in SCI and similar diseases. 15. SUBJECT TERMS 16. SECURITY...individuals with cervical SCI . We have completed a clinical feasibility study of a neuroprosthesis that provides myoelectrically-controlled hand

  19. Efficacy Study of a Fully Implanted Neuroprosthesis for Functional Benefit to Individuals with Tetraplegia

    DTIC Science & Technology

    2016-10-01

    implemented a complete marketing strategy that is specifically targeted for implantable devices in SCI, with the NNP hand system as the first product... screening protocol to IRB at MHMC and LSVA 2 100% Assemble response for IDE application to U.S. Food and Drug Administration (FDA) 1-5 100% Submit IDE...Achieved: Local IRB approval of Screening Protocol at MHMC and LSVA 3 100% Milestone Achieved: IDE approval from FDA 7 100% Milestone Achieved

  20. Non-penetrating round window electrode stimulation for tinnitus therapy followed by cochlear implantation.

    PubMed

    Wenzel, Gentiana I; Sarnes, Petra; Warnecke, Athanasia; Stöver, Timo; Jäger, Burkard; Lesinski-Schiedat, Anke; Lenarz, Thomas

    2015-11-01

    One main theory behind the origin of tinnitus is based on the idea that alterations of the spontaneous electrical activity within the auditory system lead to abnormal firing patterns in the affected nervous structures [1]. A possible therapeutic option is the use of electrical stimulation of the auditory nerve for the recovery or at least limitation of the abnormal firing pattern to a level that can be easily tolerated by the patient. The Tinnelec Implant consists of a single non-penetrating stimulation electrode connected to a Neurelec cochlear implant system. As a first feasibility study, before starting implantations in hearing patients, we thought to assess the potential of the Tinnelec stimulation to treat tinnitus in unilateral deaf patients, analysing hereby its effectivity and risks. Three patients suffering from unilateral tinnitus resistant to pharmacological treatment and ipsilateral severe to profound sensorineural hearing loss/deafness were implanted with a Tinnelec system between September 2007 and July 2008, at the ENT Department of Hannover Medical School. The stimulation strategy was chosen to induce alleviation of the tinnitus through suppression, masking and/or habituation and the response of each patient on the treatment was monitored using a visual analogue scale (VAS) on loudness and annoyance of tinnitus, mood of the patient, as well as the tinnitus handicap inventory (THI). All patients had a benefit from the electrical stimulation for their tinnitus (THI-score improvement of 20-70), however, not all participants profited from the Tinnelec system in same way and degree. In one patient, despite good results, the device had to be replaced with a conventional cochlear implant because of Tinnelec-independent increase in hearing loss on the contralateral ear. Additionally, due to the extension of cochlear implant indications, the devices of the other two patients have been meanwhile replaced with a conventional cochlear implant to benefit

  1. New cosurface capacitive stimulators for the development of active osseointegrative implantable devices

    NASA Astrophysics Data System (ADS)

    Soares Dos Santos, Marco P.; Marote, Ana; Santos, T.; Torrão, João; Ramos, A.; Simões, José A. O.; da Cruz E Silva, Odete A. B.; Furlani, Edward P.; Vieira, Sandra I.; Ferreira, Jorge A. F.

    2016-07-01

    Non-drug strategies based on biophysical stimulation have been emphasized for the treatment and prevention of musculoskeletal conditions. However, to date, an effective stimulation system for intracorporeal therapies has not been proposed. This is particularly true for active intramedullary implants that aim to optimize osseointegration. The increasing demand for these implants, particularly for hip and knee replacements, has driven the design of innovative stimulation systems that are effective in bone-implant integration. In this paper, a new cosurface-based capacitive system concept is proposed for the design of implantable devices that deliver controllable and personalized electric field stimuli to target tissues. A prototype architecture of this system was constructed for in vitro tests, and its ability to deliver controllable stimuli was numerically analyzed. Successful results were obtained for osteoblastic proliferation and differentiation in the in vitro tests. This work provides, for the first time, a design of a stimulation system that can be embedded in active implantable devices for controllable bone-implant integration and regeneration. The proposed cosurface design holds potential for the implementation of novel and innovative personalized stimulatory therapies based on the delivery of electric fields to bone cells.

  2. New cosurface capacitive stimulators for the development of active osseointegrative implantable devices

    PubMed Central

    Soares dos Santos, Marco P.; Marote, Ana; Santos, T.; Torrão, João; Ramos, A.; Simões, José A. O.; da Cruz e Silva, Odete A. B.; Furlani, Edward P.; Vieira, Sandra I.; Ferreira, Jorge A. F.

    2016-01-01

    Non-drug strategies based on biophysical stimulation have been emphasized for the treatment and prevention of musculoskeletal conditions. However, to date, an effective stimulation system for intracorporeal therapies has not been proposed. This is particularly true for active intramedullary implants that aim to optimize osseointegration. The increasing demand for these implants, particularly for hip and knee replacements, has driven the design of innovative stimulation systems that are effective in bone-implant integration. In this paper, a new cosurface-based capacitive system concept is proposed for the design of implantable devices that deliver controllable and personalized electric field stimuli to target tissues. A prototype architecture of this system was constructed for in vitro tests, and its ability to deliver controllable stimuli was numerically analyzed. Successful results were obtained for osteoblastic proliferation and differentiation in the in vitro tests. This work provides, for the first time, a design of a stimulation system that can be embedded in active implantable devices for controllable bone-implant integration and regeneration. The proposed cosurface design holds potential for the implementation of novel and innovative personalized stimulatory therapies based on the delivery of electric fields to bone cells. PMID:27456818

  3. Regenerated Sciatic Nerve Axons Stimulated through a Chronically Implanted Macro-Sieve Electrode

    PubMed Central

    MacEwan, Matthew R.; Zellmer, Erik R.; Wheeler, Jesse J.; Burton, Harold; Moran, Daniel W.

    2016-01-01

    Sieve electrodes provide a chronic interface for stimulating peripheral nerve axons. Yet, successful utilization requires robust axonal regeneration through the implanted electrode. The present study determined the effect of large transit zones in enhancing axonal regeneration and revealed an intimate neural interface with an implanted sieve electrode. Fabrication of the polyimide sieve electrodes employed sacrificial photolithography. The manufactured macro-sieve electrode (MSE) contained nine large transit zones with areas of ~0.285 mm2 surrounded by eight Pt-Ir metallized electrode sites. Prior to implantation, saline, or glial derived neurotropic factor (GDNF) was injected into nerve guidance silicone-conduits with or without a MSE. The MSE assembly or a nerve guidance conduit was implanted between transected ends of the sciatic nerve in adult male Lewis rats. At 3 months post-operation, fiber counts were similar through both implant types. Likewise, stimulation of nerves regenerated through a MSE or an open silicone conduit evoked comparable muscle forces. These results showed that nerve regeneration was comparable through MSE transit zones and an open conduit. GDNF had a minimal positive effect on the quality and morphology of fibers regenerating through the MSE; thus, the MSE may reduce reliance on GDNF to augment axonal regeneration. Selective stimulation of several individual muscles was achieved through monopolar stimulation of individual electrodes sites suggesting that the MSE might be an optimal platform for functional neuromuscular stimulation. PMID:28008303

  4. Regenerated Sciatic Nerve Axons Stimulated through a Chronically Implanted Macro-Sieve Electrode.

    PubMed

    MacEwan, Matthew R; Zellmer, Erik R; Wheeler, Jesse J; Burton, Harold; Moran, Daniel W

    2016-01-01

    Sieve electrodes provide a chronic interface for stimulating peripheral nerve axons. Yet, successful utilization requires robust axonal regeneration through the implanted electrode. The present study determined the effect of large transit zones in enhancing axonal regeneration and revealed an intimate neural interface with an implanted sieve electrode. Fabrication of the polyimide sieve electrodes employed sacrificial photolithography. The manufactured macro-sieve electrode (MSE) contained nine large transit zones with areas of ~0.285 mm(2) surrounded by eight Pt-Ir metallized electrode sites. Prior to implantation, saline, or glial derived neurotropic factor (GDNF) was injected into nerve guidance silicone-conduits with or without a MSE. The MSE assembly or a nerve guidance conduit was implanted between transected ends of the sciatic nerve in adult male Lewis rats. At 3 months post-operation, fiber counts were similar through both implant types. Likewise, stimulation of nerves regenerated through a MSE or an open silicone conduit evoked comparable muscle forces. These results showed that nerve regeneration was comparable through MSE transit zones and an open conduit. GDNF had a minimal positive effect on the quality and morphology of fibers regenerating through the MSE; thus, the MSE may reduce reliance on GDNF to augment axonal regeneration. Selective stimulation of several individual muscles was achieved through monopolar stimulation of individual electrodes sites suggesting that the MSE might be an optimal platform for functional neuromuscular stimulation.

  5. Adaptive Mechanical Stabilization of a Free-Floating Fully Implantable Hearing Aid.

    PubMed

    Einger, Till Moritz; Koch, Martin; Bornitz, Matthias; Zahnert, Thomas

    2016-10-01

    An implantable acousto-mechanical transducer will yield a higher output if its mass can be virtually increased through the use of a secondary actuator. Current hearing aids and implants rely on feedback compensation to prevent instability (e.g. howling), usually in the form of a digital or analogue filter. We examine the effect of mechanically stabilizing a piezo-driven mechanical amplifier inserted into the incudostapedial joint gap. The aim of this study is to determine whether this is possible and discern the advantages and disadvantages of the design. We examine a 10:1 scale model of a prospective implantable hearing aid comprising one piezoelectric sensor and two independent piezoelectric actuators in a single-titanium housing. As expected, the maximum gain of the device is limited by feedback between sensor input and the output of the primary actuator. The secondary actuator is used to provide a counter force to the recoil of the primary output piezo. This adds a virtual mass to the device, effectively reducing feedback in the mechano-acoustic path. The compensation unit (CU) described here is driven by a real-time adaptive control algorithm. Using the above approach, we observe an added stable gain of >30 dB, and report a functional hearing gain of up to 40 dB. Physical and digital feedback compensation can be employed in parallel for best results. The experimental data is backed by computer simulations. These results compare favorably with previous studies of a two-piezo transducer with digital feedback control and show the potential for the transducer as a hearing aid for high-frequency hearing loss.

  6. A fully integrated mixed-signal neural processor for implantable multichannel cortical recording.

    PubMed

    Sodagar, Amir M; Wise, Kensall D; Najafi, Khalil

    2007-06-01

    A 64-channel neural processor has been developed for use in an implantable neural recording microsystem. In the Scan Mode, the processor is capable of detecting neural spikes by programmable positive, negative, or window thresholding. Spikes are tagged with their associated channel addresses and formed into 18-bit data words that are sent serially to the external host. In the Monitor Mode, two channels can be selected and viewed at high resolution for studies where the entire signal is of interest. The processor runs from a 3-V supply and a 2-MHz clock, with a channel scan rate of 64 kS/s and an output bit rate of 2 Mbps.

  7. Integrated amplifiers using fully ion-implanted InP JFET's with high transconductance

    NASA Astrophysics Data System (ADS)

    Kim, Sung J.; Guth, G.; Vella-Coleiro, G. P.

    1988-06-01

    Monolithically integrated amplifiers have been fabricated using JFETs with a gate length of 1.5 microns and a maximum transconductance of 110 mS/mm, the highest ever reported for ion-implanted InP JFETs. The amplifiers utilized both a conventional direct-coupled design and a new symmetrical design. The conventional direct-coupled amplifier shows a maximum gain of 8 (18 dB) while the symmetrical amplifier design exhibits the same gain without DC offset regardless of the FET threshold voltage and the power supply voltage used.

  8. Evaluation of focused multipolar stimulation for cochlear implants in acutely deafened cats

    NASA Astrophysics Data System (ADS)

    George, Shefin S.; Wise, Andrew K.; Shivdasani, Mohit N.; Shepherd, Robert K.; Fallon, James B.

    2014-12-01

    Objective. The conductive nature of the fluids and tissues of the cochlea can lead to broad activation of spiral ganglion neurons using contemporary cochlear implant stimulation configurations such as monopolar (MP) stimulation. The relatively poor spatial selectivity is thought to limit implant performance, particularly in noisy environments. Several current focusing techniques have been proposed to reduce the spread of activation with the aim towards achieving improved clinical performance. Approach. The present research evaluated the efficacy of focused multipolar (FMP) stimulation, a relatively new focusing technique in the cochlea, and compared its efficacy to both MP stimulation and tripolar (TP) stimulation. The spread of neural activity across the inferior colliculus (IC), measured by recording the spatial tuning curve, was used as a measure of spatial selectivity. Adult cats (n = 6) were acutely deafened and implanted with an intracochlear electrode array before multi-unit responses were recorded across the cochleotopic gradient of the contralateral IC. Recordings were made in response to acoustic and electrical stimulation using the MP, TP and FMP configurations. Main results. FMP and TP stimulation resulted in greater spatial selectivity than MP stimulation. However, thresholds were significantly higher (p < 0.001) for FMP and TP stimulation compared to MP stimulation. There were no differences found in spatial selectivity and threshold between FMP and TP stimulation. Significance. The greater spatial selectivity of FMP and TP stimulation would be expected to result in improved clinical performance. However, further research will be required to demonstrate the efficacy of these modes of stimulation after longer durations of deafness.

  9. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability.

    PubMed

    Ben-Menachem, E; Revesz, D; Simon, B J; Silberstein, S

    2015-09-01

    Vagus nerve stimulation (VNS) is effective in refractory epilepsy and depression and is being investigated in heart failure, headache, gastric motility disorders and asthma. The first VNS device required surgical implantation of electrodes and a stimulator. Adverse events (AEs) are generally associated with implantation or continuous on-off stimulation. Infection is the most serious implantation-associated AE. Bradycardia and asystole have also been described during implantation, as has vocal cord paresis, which can last up to 6 months and depends on surgical skill and experience. The most frequent stimulation-associated AEs include voice alteration, paresthesia, cough, headache, dyspnea, pharyngitis and pain, which may require a decrease in stimulation strength or intermittent or permanent device deactivation. Newer non-invasive VNS delivery systems do not require surgery and permit patient-administered stimulation on demand. These non-invasive VNS systems improve the safety and tolerability of VNS, making it more accessible and facilitating further investigations across a wider range of uses. © 2015 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.

  10. Fully-distributed fiber-optic high temperature sensing based on stimulated Brillouin scattering

    NASA Astrophysics Data System (ADS)

    Wang, Jing; Hu, Di; Wang, Dorothy Y.; Wang, Anbo

    2013-06-01

    We proposed a Brillouin optical fiber time domain analysis (BOTDA)-based fully-distributed temperature system as high as 1000°C and spatial resolution to 5 meters. This technique is prominent for high spatial resolution fully distributed high temperature and stress sensing over long distance.

  11. Cochlear Implant Stimulation of a Hearing Ear Generates Separate Electrophonic and Electroneural Responses

    PubMed Central

    Baumhoff, Peter; Kral, Andrej

    2016-01-01

    Electroacoustic stimulation in subjects with residual hearing is becoming more widely used in clinical practice. However, little is known about the properties of electrically induced responses in the hearing cochlea. In the present study, normal-hearing guinea pig cochleae underwent cochlear implantation through a cochleostomy without significant loss of hearing. Using recordings of unit activity in the midbrain, we were able to investigate the excitation patterns throughout the tonotopic field determined by acoustic stimulation. With the cochlear implant and the midbrain multielectrode arrays left in place, the ears were pharmacologically deafened and electrical stimulation was repeated in the deafened condition. The results demonstrate that, in addition to direct neuronal (electroneuronal) stimulation, in the hearing cochlea excitation of the hair cells occurs (“electrophonic responses”) at the cochlear site corresponding to the dominant temporal frequency components of the electrical stimulus, provided these are < 12 kHz. The slope of the rate–level functions of the neurons in the deafened condition was steeper and the firing rate was higher than in the hearing condition at those sites that were activated in the two conditions. Finally, in a monopolar stimulation configuration, the differences between hearing status conditions were smaller than in the narrower (bipolar) configurations. SIGNIFICANCE STATEMENT Stimulation with cochlear implants and hearing aids is becoming more widely clinically used in subjects with residual hearing. The neurophysiological characteristics underlying electroacoustic stimulation and the mechanism of its benefit remain unclear. The present study directly demonstrates that cochlear implantation does not interfere with the normal mechanical and physiological function of the cochlea. For the first time, it double-dissociates the electrical responses of hair cells (electrophonic responses) from responses of the auditory nerve

  12. Feasibility of fully automated detection of fiducial markers implanted into the prostate using electronic portal imaging: A comparison of methods

    SciTech Connect

    Harris, Emma J. . E-mail: eharris@icr.ac.uk; McNair, Helen A.; Evans, Phillip M.

    2006-11-15

    Purpose: To investigate the feasibility of fully automated detection of fiducial markers implanted into the prostate using portal images acquired with an electronic portal imaging device. Methods and Materials: We have made a direct comparison of 4 different methods (2 template matching-based methods, a method incorporating attenuation and constellation analyses and a cross correlation method) that have been published in the literature for the automatic detection of fiducial markers. The cross-correlation technique requires a-priory information from the portal images, therefore the technique is not fully automated for the first treatment fraction. Images of 7 patients implanted with gold fiducial markers (8 mm in length and 1 mm in diameter) were acquired before treatment (set-up images) and during treatment (movie images) using 1MU and 15MU per image respectively. Images included: 75 anterior (AP) and 69 lateral (LAT) set-up images and 51 AP and 83 LAT movie images. Using the different methods described in the literature, marker positions were automatically identified. Results: The method based upon cross correlation techniques gave the highest percentage detection success rate of 99% (AP) and 83% (LAT) set-up (1MU) images. The methods gave detection success rates of less than 91% (AP) and 42% (LAT) set-up images. The amount of a-priory information used and how it affects the way the techniques are implemented, is discussed. Conclusions: Fully automated marker detection in set-up images for the first treatment fraction is unachievable using these methods and that using cross-correlation is the best technique for automatic detection on subsequent radiotherapy treatment fractions.

  13. An implantable electrical stimulator used for peripheral nerve rehabilitation in rats

    PubMed Central

    RUI, BIYU; GUO, SHANGCHUN; ZENG, BINGFANG; WANG, JINGWU; CHEN, XIN

    2013-01-01

    This study evaluated an implantable electrical stimulator using a sciatic nerve injury animal model, and ethological, electrophysiological and histological assessments. Forty Sprague-Dawley rats were used in the study, and were subjected to crushing of the right sciatic nerve with a micro-vessel clamp. Electrical stimulators were implanted in twenty of the rats (the implantation group), while the remaining twenty rats were assigned to the control group. At three and six weeks following the surgery, the sciatic nerve function index (SFI) and the motor nerve conduction velocity (MCV) were demonstrated to be significantly higher in the implantation group compared with the control group (P<0.05). Histological analysis, using hematoxylin and eosin (H&E) staining, showed the typical pathological atrophy, and an assessment of the nerve that had been crushed revealed distal axonal breakdown in the control group. These results suggest that the implantable electrical stimulator was effective, and was suitable for implantation in a Sprague-Dawley rat model. PMID:23935712

  14. Implantable power generation system utilizing muscle contractions excited by electrical stimulation.

    PubMed

    Sahara, Genta; Hijikata, Wataru; Tomioka, Kota; Shinshi, Tadahiko

    2016-06-01

    An implantable power generation system driven by muscle contractions for supplying power to active implantable medical devices, such as pacemakers and neurostimulators, is proposed. In this system, a muscle is intentionally contracted by an electrical stimulation in accordance with the demands of the active implantable medical device for electrical power. The proposed system, which comprises a small electromagnetic induction generator, electrodes with an electrical circuit for stimulation and a transmission device to convert the linear motion of the muscle contractions into rotational motion for the magneto rotor, generates electrical energy. In an ex vivo demonstration using the gastrocnemius muscle of a toad, which was 28 mm in length and weighed 1.3 g, the electrical energy generated by the prototype exceeded the energy consumed for electrical stimulation, with the net power being 111 µW. It was demonstrated that the proposed implantable power generation system has the potential to replace implantable batteries for active implantable medical devices.

  15. High-Frequency Spinal Cord Stimulation in a Patient with an Implanted Cardiac Device.

    PubMed

    Kissoon, Narayan R; Hoelzer, Bryan C; Martin, David P; Lamer, Tim J

    2017-04-01

    New advances in spinal cord stimulation have led to improved treatment of patients suffering from chronic pain. While the overall safety of newer stimulation devices has been established, no published reports exist regarding safety considerations when these devices are implanted in patients with a preexisting cardiac device. An 83-year-old man with a history of out-of-hospital cardiac arrest secondary to an episode of ventricular fibrillation underwent automated implantable cardiac defibrillator placement. Concomitantly, he suffered from intractable chronic low axial back pain and was deemed a candidate for high-frequency (10 kHz) spinal cord stimulation (SCS). Cardiac monitoring during SCS trial and implantation was performed with no interference noted. Following high-frequency SCS implantation, the patient was observed to have significant pain relief with functional improvement. While others have reported safety during traditional SCS in patients with implanted cardiac devices, this is the first case report to describe safe and effective use of high-frequency SCS in a patient with an implanted cardiac device. © 2016 World Institute of Pain.

  16. Correction of Footdrop Due to Multiple Sclerosis Using the STIMuSTEP Implanted Dropped Foot Stimulator

    PubMed Central

    Wilkinson Hart, Ingrid A.; Khan, Mansoor S.; Slade-Sharman, Diana E.M.

    2016-01-01

    Background: Footdrop is a significant problem in multiple sclerosis, reducing the safety and efficiency of walking. Functional electrical stimulation (FES) can produce dorsiflexion, correcting footdrop. The purpose of this retrospective analysis of clinical study data was to compare the effect of external and implanted FES devices for the correction of footdrop. Methods: External FES was used for a minimum of 6 months before implantation. Walking performance was assessed using 10-m walking speed, 3-minute walking distance, the Physiological Cost Index, and health- and device-related quality of life and device-use questionnaires. Assessments were made before implantation and a mean (SD) of 128 (24) days after surgery, with additional walking speed measurements at 3 years. Results: Twenty-three people with multiple sclerosis received the STIMuSTEP implant. Both devices enabled statistically significant increases in walking speed and walking distance, with a strong trend toward a reduced Physiological Cost Index, indicating that walking required less effort (P = .07). Both devices improved device-related quality of life. Walking speed gain with FES was maintained at 3 years. Three implants failed after falls, and there was one case of neuropraxia. The implant was used more days per week and was quicker to put on each day than the external FES device. Conclusions: The STIMuSTEP implanted dropped foot stimulator is an effective long-term intervention for the correction of footdrop. PMID:27803639

  17. Correction of Footdrop Due to Multiple Sclerosis Using the STIMuSTEP Implanted Dropped Foot Stimulator.

    PubMed

    Taylor, Paul N; Wilkinson Hart, Ingrid A; Khan, Mansoor S; Slade-Sharman, Diana E M

    2016-01-01

    Background: Footdrop is a significant problem in multiple sclerosis, reducing the safety and efficiency of walking. Functional electrical stimulation (FES) can produce dorsiflexion, correcting footdrop. The purpose of this retrospective analysis of clinical study data was to compare the effect of external and implanted FES devices for the correction of footdrop. Methods: External FES was used for a minimum of 6 months before implantation. Walking performance was assessed using 10-m walking speed, 3-minute walking distance, the Physiological Cost Index, and health- and device-related quality of life and device-use questionnaires. Assessments were made before implantation and a mean (SD) of 128 (24) days after surgery, with additional walking speed measurements at 3 years. Results: Twenty-three people with multiple sclerosis received the STIMuSTEP implant. Both devices enabled statistically significant increases in walking speed and walking distance, with a strong trend toward a reduced Physiological Cost Index, indicating that walking required less effort (P = .07). Both devices improved device-related quality of life. Walking speed gain with FES was maintained at 3 years. Three implants failed after falls, and there was one case of neuropraxia. The implant was used more days per week and was quicker to put on each day than the external FES device. Conclusions: The STIMuSTEP implanted dropped foot stimulator is an effective long-term intervention for the correction of footdrop.

  18. Longitudinal Hemodynamic Measurements in Swine Heart Failure Using a Fully Implantable Telemetry System

    PubMed Central

    Choy, Jenny S.; Zhang, Zhen-Du; Pitsillides, Koullis; Sosa, Margo; Kassab, Ghassan S.

    2014-01-01

    Chronic monitoring of heart rate, blood pressure, and flow in conscious free-roaming large animals can offer considerable opportunity to understand the progression of cardiovascular diseases and can test new diagnostics and therapeutics. The objective of this study was to demonstrate the feasibility of chronic, simultaneous measurement of several hemodynamic parameters (left ventricular pressure, systemic pressure, blood flow velocity, and heart rate) using a totally implantable multichannel telemetry system in swine heart failure models. Two solid-state blood pressure sensors were inserted in the left ventricle and the descending aorta for pressure measurements. Two Doppler probes were placed around the left anterior descending (LAD) and the brachiocephalic arteries for blood flow velocity measurements. Electrocardiographic (ECG) electrodes were attached to the surface of the left ventricle to monitor heart rate. The telemeter body was implanted in the right side of the abdomen under the skin for approximately 4 to 6 weeks. The animals were subjected to various heart failure models, including volume overload (A-V fistula, n = 3), pressure overload (aortic banding, n = 2) and dilated cardiomyopathy (pacing-induced tachycardia, n = 3). Longitudinal changes in hemodynamics were monitored during the progression of the disease. In the pacing-induced tachycardia animals, the systemic blood pressure progressively decreased within the first 2 weeks and returned to baseline levels thereafter. In the aortic banding animals, the pressure progressively increased during the development of the disease. The pressure in the A-V fistula animals only showed a small increase during the first week and remained stable thereafter. The results demonstrated the ability of this telemetry system of long-term, simultaneous monitoring of blood flow, pressure and heart rate in heart failure models, which may offer significant utility for understanding cardiovascular disease

  19. Longitudinal hemodynamic measurements in swine heart failure using a fully implantable telemetry system.

    PubMed

    Choy, Jenny S; Zhang, Zhen-Du; Pitsillides, Koullis; Sosa, Margo; Kassab, Ghassan S

    2014-01-01

    Chronic monitoring of heart rate, blood pressure, and flow in conscious free-roaming large animals can offer considerable opportunity to understand the progression of cardiovascular diseases and can test new diagnostics and therapeutics. The objective of this study was to demonstrate the feasibility of chronic, simultaneous measurement of several hemodynamic parameters (left ventricular pressure, systemic pressure, blood flow velocity, and heart rate) using a totally implantable multichannel telemetry system in swine heart failure models. Two solid-state blood pressure sensors were inserted in the left ventricle and the descending aorta for pressure measurements. Two Doppler probes were placed around the left anterior descending (LAD) and the brachiocephalic arteries for blood flow velocity measurements. Electrocardiographic (ECG) electrodes were attached to the surface of the left ventricle to monitor heart rate. The telemeter body was implanted in the right side of the abdomen under the skin for approximately 4 to 6 weeks. The animals were subjected to various heart failure models, including volume overload (A-V fistula, n = 3), pressure overload (aortic banding, n = 2) and dilated cardiomyopathy (pacing-induced tachycardia, n = 3). Longitudinal changes in hemodynamics were monitored during the progression of the disease. In the pacing-induced tachycardia animals, the systemic blood pressure progressively decreased within the first 2 weeks and returned to baseline levels thereafter. In the aortic banding animals, the pressure progressively increased during the development of the disease. The pressure in the A-V fistula animals only showed a small increase during the first week and remained stable thereafter. The results demonstrated the ability of this telemetry system of long-term, simultaneous monitoring of blood flow, pressure and heart rate in heart failure models, which may offer significant utility for understanding cardiovascular disease progression and

  20. Anaesthetic management of a patient with deep brain stimulation implant for radical nephrectomy.

    PubMed

    Khetarpal, Monica; Yadav, Monu; Kulkarni, Dilip; Gopinath, R

    2014-07-01

    A 63-year-old man with severe Parkinson's disease (PD) who had been implanted with deep brain stimulators into both sides underwent radical nephrectomy under general anaesthesia with standard monitoring. Deep brain stimulation (DBS) is an alternative and effective treatment option for severe and refractory PD and other illnesses such as essential tremor and intractable epilepsy. Anaesthesia in the patients with implanted neurostimulator requires special consideration because of the interaction between neurostimulator and the diathermy. The diathermy can damage the brain tissue at the site of electrode. There are no standard guidelines for the anaesthetic management of a patient with DBS electrode in situ posted for surgery.

  1. Using Fully Coupled Hydro-Geomechanical Numerical Test Bed to Study Reservoir Stimulation with Low Hydraulic Pressure

    DOE Data Explorer

    Fu, Pengcheng; Johnson, Scott M.; Carrigan, Charles R.

    2012-01-31

    This paper documents our effort to use a fully coupled hydro-geomechanical numerical test bed to study using low hydraulic pressure to stimulate geothermal reservoirs with existing fracture network. In this low pressure stimulation strategy, fluid pressure is lower than the minimum in situ compressive stress, so the fractures are not completely open but permeability improvement can be achieved through shear dilation. We found that in this low pressure regime, the coupling between the fluid phase and the rock solid phase becomes very simple, and the numerical model can achieve a low computational cost. Using this modified model, we study the behavior of a single fracture and a random fracture network.

  2. Neural Probes with Integrated Temperature Sensors for Monitoring Retina and Brain Implantation and Stimulation.

    PubMed

    Wang, Jiaqi; Xie, Hui; Chung, Tsing; Chan, Leanne Lai Hang; Pang, Stella W

    2017-09-01

    Gold (Au) resistive temperature sensors were integrated on flexible polyimide-based neural probes to monitor temperature changes during neural probe implantation and stimulation. Temperature changes were measured as neural probes were implanted to infer the positions of the neural probes, and as the retina or the deep brain region was stimulated electrically. The temperature sensor consisted of a serpentine Au resistor and surrounded by four Au electrodes with 200 and [Formula: see text] diameter (dia.). The Au temperature sensors had temperature coefficient of 0.32%, and they were biocompatible and small in size. In vivo measurements of temperature changes during implantation and stimulation were carried out in the retina and deep brain region in rats. The desired implantation position was reached when temperature measured by the sensor increased to the calibrated level and became stable. There was no temperature increase when low level stimulation current of 8 and [Formula: see text] each for the two 200- and 400- [Formula: see text]-dia. electrodes, respectively, were applied. When higher level stimulation current of 100 and [Formula: see text] each were applied to the two 200- and 400- [Formula: see text]-dia. electrodes, respectively, maximum temperature increases of 1.2 °C in retina and 1 °C in deep brain region were found.

  3. Speech perception with interaction-compensated simultaneous stimulation and long pulse durations in cochlear implant users.

    PubMed

    Schatzer, Reinhold; Koroleva, Inna; Griessner, Andreas; Levin, Sergey; Kusovkov, Vladislav; Yanov, Yuri; Zierhofer, Clemens

    2015-04-01

    Early multi-channel designs in the history of cochlear implant development were based on a vocoder-type processing of frequency channels and presented bands of compressed analog stimulus waveforms simultaneously on multiple tonotopically arranged electrodes. The realization that the direct summation of electrical fields as a result of simultaneous electrode stimulation exacerbates interactions among the stimulation channels and limits cochlear implant outcome led to the breakthrough in the development of cochlear implants, the continuous interleaved (CIS) sampling coding strategy. By interleaving stimulation pulses across electrodes, CIS activates only a single electrode at each point in time, preventing a direct summation of electrical fields and hence the primary component of channel interactions. In this paper we show that a previously presented approach of simultaneous stimulation with channel interaction compensation (CIC) may also ameliorate the deleterious effects of simultaneous channel interaction on speech perception. In an acute study conducted in eleven experienced MED-EL implant users, configurations involving simultaneous stimulation with CIC and doubled pulse phase durations have been investigated. As pairs of electrodes were activated simultaneously and pulse durations were doubled, carrier rates remained the same. Comparison conditions involved both CIS and fine structure (FS) strategies, either with strictly sequential or paired-simultaneous stimulation. Results showed no statistical difference in the perception of sentences in noise and monosyllables for sequential and paired-simultaneous stimulation with doubled phase durations. This suggests that CIC can largely compensate for the effects of simultaneous channel interaction, for both CIS and FS coding strategies. A simultaneous stimulation paradigm has a number of potential advantages over a traditional sequential interleaved design. The flexibility gained when dropping the requirement of

  4. Concept Developed for an Implanted Stimulated Muscle-Powered Piezoelectric Generator

    NASA Technical Reports Server (NTRS)

    Lewandowski, Beth; Kilgore, Kevin; Ercegovic, David; Gustafson, Kenneth

    2005-01-01

    Implanted electronic devices are typically powered by batteries or transcutaneous power transmission. Batteries must be replaced or recharged, and transcutaneous power sources burden the patient or subject with external equipment prone to failure. A completely self-sustaining implanted power source would alleviate these limitations. Skeletal muscle provides an available autologous power source containing native chemical energy that produces power in excess of the requirements for muscle activation by motor nerve stimulation. A concept has been developed to convert stimulated skeletal muscle power into electrical energy (see the preceding illustration). We propose to connect a piezoelectric generator between a muscle tendon and bone. Electrically stimulated muscle contractions would exert force on the piezoelectric generator, charging a storage circuit that would be used to power the stimulator and other devices.

  5. Toward an implantable functional electrical stimulation device to correct strabismus

    PubMed Central

    Velez, Federico G.; Isobe, Jun; Zealear, David; Judy, Jack W.; Edgerton, V. Reggie; Patnode, Stephanie; Lee, Hyowon; Hahn, Brian T.

    2010-01-01

    PURPOSE To investigate the feasibility of electrically stimulating the lateral rectus muscle to recover its physiologic abduction ability in cases of complete sixth cranial (abducens) nerve palsy. METHODS In the feline lateral rectus muscle model, the effects of a charge-balanced, biphasic, current-controlled stimulus on the movement of the eye were investigated while stimulation frequency, amplitude, and pulse duration was varied. Eye deflection was measured with a force transducer. Denervated conditions were simulated by injection of botulinum toxin A. RESULTS Three chemically denervated and 4 control lateral rectus muscles were analyzed. In control lateral rectus muscles, the minimum fusion frequency was approximately 170 Hz, and the maximum evoked abduction was 27°. The minimum fusion frequency was unchanged after 4 weeks of chemical denervation. Stimulation of chemically denervated lateral rectus muscle resulted in 17° of abduction. For both innervated and chemically denervated lateral rectus muscle, frequencies greater than 175 Hz yielded very little increase in abduction. Modulating amplitude produced noticeable movement throughout the tested range (0.2 to 9 mA). CONCLUSIONS Results from the feline lateral rectus muscle showed that electrical stimulation is a feasible approach to evoke a contraction from a denervated lateral rectus muscle. The degree of denervation of the feline lateral rectus muscle was indeterminate. Varying the stimulation amplitude allowed greater eye movement. It is very likely that both frequency and amplitude must be modulated for finer control of static eye position. PMID:19375369

  6. Development of a polymer based fully flexible electrode tip for neuronal micro-stimulation applications

    NASA Astrophysics Data System (ADS)

    David, Romain; Miki, Norihisa

    2017-06-01

    Neural stimulation systems design is highly impacted by the overall resolution and adaptability of the device to the targeted application and area to stimulate. In this paper, we report a novel design for neural micro-stimulation electrode presenting high resolution and adaptability to any targeted area via a high flexibility. We propose the use of liquid metal micro-channels encapsulated into a polymer volume, achieving micro-stimulation pads at the tip of the channels. It presents a high degree of patternability to match different possible targeted applications, and good flexibility and mechanic properties to make it insertable and adaptable into soft tissues. A stable fabrication process, including insertion of the liquid alloy into 50 µm half-channels, the necessity of the U-shape to produce functional conductive micro-channels and the mechanical integrity of the device are discussed.

  7. Evoked EMG-based torque prediction under muscle fatigue in implanted neural stimulation

    NASA Astrophysics Data System (ADS)

    Hayashibe, Mitsuhiro; Zhang, Qin; Guiraud, David; Fattal, Charles

    2011-10-01

    In patients with complete spinal cord injury, fatigue occurs rapidly and there is no proprioceptive feedback regarding the current muscle condition. Therefore, it is essential to monitor the muscle state and assess the expected muscle response to improve the current FES system toward adaptive force/torque control in the presence of muscle fatigue. Our team implanted neural and epimysial electrodes in a complete paraplegic patient in 1999. We carried out a case study, in the specific case of implanted stimulation, in order to verify the corresponding torque prediction based on stimulus evoked EMG (eEMG) when muscle fatigue is occurring during electrical stimulation. Indeed, in implanted stimulation, the relationship between stimulation parameters and output torques is more stable than external stimulation in which the electrode location strongly affects the quality of the recruitment. Thus, the assumption that changes in the stimulation-torque relationship would be mainly due to muscle fatigue can be made reasonably. The eEMG was proved to be correlated to the generated torque during the continuous stimulation while the frequency of eEMG also decreased during fatigue. The median frequency showed a similar variation trend to the mean absolute value of eEMG. Torque prediction during fatigue-inducing tests was performed based on eEMG in model cross-validation where the model was identified using recruitment test data. The torque prediction, apart from the potentiation period, showed acceptable tracking performances that would enable us to perform adaptive closed-loop control through implanted neural stimulation in the future.

  8. Effects of electrical stimulation rate on speech recognition in cochlear implant users.

    PubMed

    Park, Sung Hye; Kim, Eunoak; Lee, Hyo-Jeong; Kim, Hyung-Jong

    2012-04-01

    The stimulus signals delivered in cochlear implant (CI) systems are generally derived by sampling the temporal envelope of each channel at some constant rate and using its intensity to control the stimulation current level delivered to the corresponding electrode site. The objective of the study was to investigate speech recognition performance of cochlear implant users in quiet and noisy environments using either moderate or high rates of electrical stimulations. Six post-lingually deafened adult users of the Nucleus CI24 cochlear implant (Contour® electrode array, Cochlear™, Macquarie Park, Australia) with the Freedom® speech processor participated in the study. Stimulation rates of 900 and 2400 pulses-per-second/channel (pps/ch) were used after both stimulation programs were balanced for loudness. Monosyllabic word and sentence recognition scores in quiet and noisy environments were evaluated for each stimulation program after two months of practice. Subjects were also asked to respond to a questionnaire to examine their preference to any stimulation rate in different hearing conditions. Word recognition scores for monosyllabic words in quiet conditions with the 900 stimulation rate was better than that of the 2400 stimulation rate, although no significant differences between them were found for sentence test in noise. A survey questionnaire indicated that most subjects preferred the 900 stimulation rate to the 2400 stimulation rate, especially in quiet conditions. Most subjects indicated a preference for 900 pps/ch rate in quiet conditions. It is recommended to remap at 900 pps/ch for those CI users whose performance in quiet conditions is less than ideal.

  9. Greater occipital nerve stimulation via the Bion microstimulator: implantation technique and stimulation parameters. Clinical trial: NCT00205894.

    PubMed

    Trentman, Terrence L; Rosenfeld, David M; Vargas, Bert B; Schwedt, Todd J; Zimmerman, Richard S; Dodick, David W

    2009-01-01

    Millions of patients suffer from medically refractory and disabling primary headache disorders. This problem has led to a search for new and innovative treatment modalities, including neuromodulation of the occipital nerves. The primary aim of this study is to describe an implantation technique for the Bion microstimulator and document stimulation parameters and stimulation maps after Bion placement adjacent to the greater occipital nerve. The secondary aim is to document outcome measures one year post-implant. Prospective, observational feasibility study. Nine patients with medically refractory primary headache disorders participated in this study. Approximately 6 months after Bion insertion, stimulation parameters and maps were documented for all patients. At one year, outcome measures were collected including the Migraine Disability Assessment Score. At 6 months, the mean perception threshold was 0.47 mA, while the mean discomfort threshold was 6.8 mA (stimulation range 0.47-6.8 mA). The mean paresthesia threshold was 1.64 mA and the mean usage range was 16.0. There were no major complications reported such as device migration, infection, or erosion. One patient stopped using her Bion before the 12-month follow-up visit. At one year, 7 of the 8 patients were judged as having obtained fair or better results in terms of reduction of disability; 5 patients had greater than a 90% reduction in disability. Small, heterogeneous patient population without control group. Not blinded or randomized. The Bion can be successfully inserted adjacent to the greater occipital nerve in an effort to treat refractory primary headache disorders. This microstimulator may provide effective occipital stimulation and headache control while minimizing the risks associated with percutaneous or paddle leads implanted subcutaneously in the occipital region.

  10. Subpectoral Implantation of Internal Pulse Generators for Deep Brain Stimulation: Technical Note for Improved Cosmetic Outcomes.

    PubMed

    White-Dzuro, Gabrielle A; Lake, Wendell; Neimat, Joseph S

    2017-08-01

    Deep brain stimulation is increasingly used to treat a variety of disorders. As the prevalence of this technology increases, greater demands are placed on neurosurgical practitioners to improve cosmetic results, maximize patient comfort, and minimize complication rates. We have increasingly employed subpectoral implantation of internal pulse generators (IPGs) to improve patient satisfaction. To determine the complication rates of subpectorally placed IPGs as compared to those placed in a subcutaneous location. We reviewed a series of 301 patients from a single institution. Complication rates including infection, hematoma, and lead fracture were recorded. Rates were compared for subcutaneously and subpectorally located devices. Of the records reviewed, we found 301 patients who underwent 308 procedures for initial IPG implantation. Of these, 275 were subpectoral IPG implantation, 19 were infraclavicular subcutaneous implantation, and 14 were subcutaneous implantation in the abdomen. A total of 6 IPG pocket infections occurred, 2 subpectoral and 4 infraclavicular subcutaneous. Of the IPG infections, 2 of the infraclavicular subcutaneous devices had associated erosions. Two patients had their devices relocated from a subpectoral pocket to a subcutaneous pocket in the abdomen due to discomfort. Two patients in the subpectoral group suffered from hematoma requiring evacuation. Two patients in the infraclavicular subcutaneous group had lead fracture occur. Subpectoral implantation of deep brain stimulation IPGs is a viable alternative with a low complication rate. This technique may offer a lower rate of infection and wound erosion.

  11. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic... to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an...

  12. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic... to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an...

  13. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic... to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an...

  14. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic... to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an...

  15. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic... to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an...

  16. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical...

  17. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical...

  18. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical...

  19. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical...

  20. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical...

  1. Effects of vestibular prosthesis electrode implantation and stimulation on hearing in rhesus monkeys.

    PubMed

    Dai, Chenkai; Fridman, Gene Y; Della Santina, Charles C

    2011-07-01

    To investigate the effects of vestibular prosthesis electrode implantation and activation on hearing in rhesus monkeys, we measured auditory brainstem responses (ABR) and distortion product otoacoustic emissions (DPOAE) in four rhesus monkeys before and after unilateral implantation of vestibular prosthesis electrodes in each of 3 left semicircular canals (SCC). Each of the 3 left SCCs were implanted with electrodes via a transmastoid approach. Right ears, which served as controls, were not surgically manipulated. Hearing tests were conducted before implantation (BI) and then 4 weeks post-implantation both without electrical stimulation (NS) and with electrical stimulation (S). During the latter condition, prosthetic electrical stimuli encoding 3 dimensions of head angular velocity were delivered to the 3 ampullary branches of the left vestibular nerve via each of 3 electrode pairs of a multichannel vestibular prosthesis. Electrical stimuli comprised charge-balanced biphasic pulses at a baseline rate of 94 pulses/s, with pulse frequency modulated from 48 to 222 pulses/s by head angular velocity. ABR hearing thresholds to clicks and tone pips at 1, 2, and 4 kHz increased by 5-10 dB from BI to NS and increased another ∼5 dB from NS to S in implanted ears. No significant change was seen in right ears. DPOAE amplitudes decreased by 2-14 dB from BI to NS in implanted ears. There was a slight but insignificant decrease of DPOAE amplitude and a corresponding increase of DPOAE/Noise floor ratio between NS and S in implanted ears. Vestibular prosthesis electrode implantation and activation have small but measurable effects on hearing in rhesus monkeys. Coupled with the clinical observation that patients with cochlear implants only rarely exhibit signs of vestibular injury or spurious vestibular nerve stimulation, these results suggest that although implantation and activation of multichannel vestibular prosthesis electrodes in human will carry a risk of hearing loss

  2. Late Extrusion of an Implantable Pulse Generator of a Spinal Cord Stimulator.

    PubMed

    Rabi, Joseph; Anitescu, Magdalena

    2016-05-01

    The objective of this manuscript was to report a case of a patient with extruded pulse generator 3 years after implantation of a spinal cord stimulator system.With the increasing incidence of chronic pain, spinal cord stimulation (SCS) is becoming more commonly utilized by pain physicians. SCS is a generally safe intervention with minimal adverse effects; however, there are risks of complications which practitioners should be aware of prior to and after placement of the SCS. We present a case of a patient with a late complication of extrusion of an implantable pulse generator (IPG) of a SCS that was promptly identified and successfully removed without any complications. A 60-year-old male truck driver with history of failed back syndrome and diabetes underwent a SCS system implanted with excellent relief of his pain. The SCS was implanted with 2 leads with the IPG being sutured 3 cm in depth in the superior gluteal region. Three years after the implantation, he developed pain over the site of the generator and presented to our clinic with extrusion of the non-rechargeable pulse generator from his gluteal region.The pulse generator was successfully removed with the battery not being infected. This late complication may have been related to his ongoing profession of daily driving with pressure necrosis from prolonged sitting and constant vibration during long rides associated. Structural size and design of the pulse generator may have had an important contribution as well. To our knowledge this complication has not been reported in the literature.Physicians that place or manage patients with SCSs should be aware of this rare complication and maintain vigilance even after remote implantation of the SCS systems. Spinal cord stimulator, complication, extrusion, implantable pulse generator, neuromodulation, failed back syndrome, battery complication.

  3. Vestibular evoked myogenic potential testing as an objective measure of vestibular stimulation with cochlear implants.

    PubMed

    Parkes, William J; Gnanasegaram, Joshua J; Cushing, Sharon L; McKnight, Carmen L; Papsin, Blake C; Gordon, Karen A

    2017-02-01

    To determine if vestibular potentials could be elicited with electrical stimulation from cochlear implants. Prospective cohort study. Vestibular responsiveness to electrical stimulation from cochlear implants was assessed via vestibular evoked myogenic potential (VEMP) testing in 53 pediatric and young adult patients. Thirty-one participants (58%) showed at least one vestibular potential in response to acoustic stimulation; 33 (62%) had an electrically evoked vestibular response. A cervical VEMP (cVEMP) was present in 45 of the 96 tested ears (47%) in response to acoustic stimulation, and in 34 ears (35%) with electrical stimulation. An ocular VEMP (oVEMP) was elicited acoustically in 25 ears (26%) and electrically in 34 (35%) ears. In the ears with absent responses to acoustic stimuli, electrically evoked cVEMPs and oVEMPs were present in 14 (27%) and 18 (25%) ears, respectively. Electric VEMPs demonstrated shorter latencies than acoustic VEMPs (P < .01). Whereas an increased prevalence of VEMPs was seen at high stimulation levels (P < .01), there was no difference between prevalence proportions with basal (electrode 3) or apical (electrode 20) stimulation (P > .05). VEMPs can be elicited with electrical stimulation in a proportion of children with cochlear implants, demonstrating current spread from the cochlea to the vestibular system. The presence of electric VEMPs in acoustically nonresponsive ears, along with the shorter latencies of electrically driven VEMPs, suggests that electrical current can bypass the otoliths and directly stimulate vestibular neural elements. 4. Laryngoscope, 2016 127:E75-E81, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

  4. Nanomaterials and synergistic low intensity direct current (LIDC) stimulation technology for orthopaedic implantable medical devices

    PubMed Central

    Samberg, Meghan E.; Cohen, Paul H.; Wysk, Richard A.; Monteiro-Riviere, Nancy A.

    2012-01-01

    Nanomaterials play a significant role in biomedical research and applications due to their unique biological, mechanical, and electrical properties. In recent years, they have been utilised to improve the functionality and reliability of a wide range of implantable medical devices ranging from well-established orthopaedic residual hardware devices (e.g. hip implants) that can repair defects in skeletal systems to emerging tissue engineering scaffolds that can repair or replace organ functions. This review summarizes the applications and efficacies of these nanomaterials that include synthetic or naturally occurring metals, polymers, ceramics, and composites in orthopaedic implants, the largest market segment of implantable medical devices. The importance of synergistic engineering techniques that can augment or enhance the performance of nanomaterial applications in orthopaedic implants is also discussed,, the focus being on a low intensity direct electric current (LIDC) stimulation technology to promote the long-term antibacterial efficacy of oligodynamic metal-based surfaces by ionization, while potentially accelerating tissue growth and osseointegration. While many nanomaterials have clearly demonstrated their ability to provide more effective implantable medical surfaces, further decisive investigations are necessary before they can translate into medically safe and commercially viable clinical applications. The paper concludes with a discussion about some of the critical impending issues with the application of nanomaterials-based technologies in implantable medical devices, and potential directions to address these. PMID:23335493

  5. Nanomaterials and synergistic low-intensity direct current (LIDC) stimulation technology for orthopedic implantable medical devices.

    PubMed

    Shirwaiker, Rohan A; Samberg, Meghan E; Cohen, Paul H; Wysk, Richard A; Monteiro-Riviere, Nancy A

    2013-01-01

    Nanomaterials play a significant role in biomedical research and applications because of their unique biological, mechanical, and electrical properties. In recent years, they have been utilized to improve the functionality and reliability of a wide range of implantable medical devices ranging from well-established orthopedic residual hardware devices (e.g., hip implants) that can repair defects in skeletal systems to emerging tissue engineering scaffolds that can repair or replace organ functions. This review summarizes the applications and efficacies of these nanomaterials that include synthetic or naturally occurring metals, polymers, ceramics, and composites in orthopedic implants, the largest market segment of implantable medical devices. The importance of synergistic engineering techniques that can augment or enhance the performance of nanomaterial applications in orthopedic implants is also discussed, the focus being on a low-intensity direct electric current (LIDC) stimulation technology to promote the long-term antibacterial efficacy of oligodynamic metal-based surfaces by ionization, while potentially accelerating tissue growth and osseointegration. While many nanomaterials have clearly demonstrated their ability to provide more effective implantable medical surfaces, further decisive investigations are necessary before they can translate into medically safe and commercially viable clinical applications. The article concludes with a discussion about some of the critical impending issues with the application of nanomaterials-based technologies in implantable medical devices, and potential directions to address these. Copyright © 2013 Wiley Periodicals, Inc.

  6. Recent advances in power efficient output stage for high density implantable stimulators.

    PubMed

    Sooksood, Kriangkrai; Noorsal, Emilia; Bihr, Ulrich; Ortmanns, Maurits

    2012-01-01

    A major drawback of a current-controlled stimulation is its power efficiency. However, it is commonly used in implantable stimulators due to its safety. The power efficiency of a current-controlled stimulation can be improved by reducing the headroom voltage needed in the current driver. A promising technique is to bias the transistor in triode region whereas improving output impedance through the regulated cascode structure. This comes with a feature of implicit compliance monitor which is used for the supply voltage adaptation. This paper presents an overview on recent power efficient high voltage-compliance output drivers.

  7. An implantable device for neuropsychiatric rehabilitation by chronic deep brain stimulation in freely moving rats

    PubMed Central

    Wang, Chenguang; Zhang, Fuqiang; Jia, Hong

    2017-01-01

    Successful practice of clinical deep brain stimulation (DBS) calls for basic research on the mechanisms and explorations of new indications in animals. In the article, a new implantable, single-channel, low-power miniature device is proposed, which may transmit pulses chronically into the brain nucleus of freely moving rats. The DBS system consists of an implantable pulse generator (IPG), a bipolar electrode, and an external programmer. The IPG circuit module is assembled as a 20-mm diameter circular board and fixed on a rat’s skull together with an electrode and battery. The rigid electrode may make its fabrication and implantation more easy. The external programmer is designed for bidirectional communication with the IPG by a telecontrol transceiver and adjusts stimulation parameters. A biological validation was performed in which the effects of electrical stimulation in brain nucleus accumbens were detected. The programmed parameters were accurate, implant steady, and power sufficient to allow stimulation for more than 3 months. The larger area of the electrode tip provided a moderate current or charge density and minimized the damage from electrochemistry and pyroelectricity. The rats implanted with the device showed a reduction in morphine-induced conditioned place preference after high-frequency stimulation. In conclusion, the DBS device is based on the criteria of simple technology, minimal invasion, low cost, small in size, light-weight, and wireless controlled. This shows that our DBS device is appropriate and can be used for preclinical studies, indicating its potential utility in the therapy and rehabilitation of neuropsychiatric disorders. PMID:28121810

  8. Bimodal Stimulation with Cochlear Implant and Hearing Aid in Cases of Highly Asymmetrical Hearing Loss.

    PubMed

    Sanhueza, Ignacio; Manrique, Raquel; Huarte, Alicia; de Erenchun, Iñigo Ruiz; Manrique, Manuel

    2016-04-01

    Bimodal stimulation is a possible treatment for asymmetrical hearing loss, wherein 1 ear is stimulated with a cochlear implant and the other is stimulated with a hearing aid. This emerging indication has gained significance over the last few years. However, little research has been conducted regarding the performance in different types of asymmetric Hearing loss. This study seeks to prove the bilateral-binaural advantage in a group of patients treated with bimodal stimulation (cochlear implant and hearing aid), with different degrees of hearing loss in their best ear. In total, 31 patients were recruited for the study. They were divided into 3 groups on the basis of the ear with the hearing aid: Group A, pure tone average (PTA) between 41 and 70 dB HL; Group B, PTA between 71 and 80 dB HL; and Group C, PTA between 81 and 90 dB HL. The performance in PTA and disyllabic word recognition were analyzed separately in each ear and then bimodally. The minimum follow-up period was 2 years. There were statistically significant differences between bimodal and monaural conditions both in PTA and in disyllabic word recognition. The better the residual hearing in the ear with the hearing aid, the greater were the benefits obtained with bilateralism-binaurality. Bimodal stimulation provides better results than any monaural hearing mode, regardless of whether it involves the use of a hearing aid alone or a cochlear implant alone.

  9. In vivo demonstration of a self-sustaining, implantable, stimulated-muscle-powered piezoelectric generator prototype.

    PubMed

    Lewandowski, B E; Kilgore, K L; Gustafson, K J

    2009-11-01

    An implantable, stimulated-muscle-powered piezoelectric active energy harvesting generator was previously designed to exploit the fact that the mechanical output power of muscle is substantially greater than the electrical power necessary to stimulate the muscle's motor nerve. We reduced to practice the concept by building a prototype generator and stimulator. We demonstrated its feasibility in vivo, using rabbit quadriceps to drive the generator. The generated power was sufficient for self-sustaining operation of the stimulator and additional harnessed power was dissipated through a load resistor. The prototype generator was developed and the power generating capabilities were tested with a mechanical muscle analog. In vivo generated power matched the mechanical muscle analog, verifying its usefulness as a test-bed for generator development. Generator output power was dependent on the muscle stimulation parameters. Simulations and in vivo testing demonstrated that for a fixed number of stimuli/minute, two stimuli applied at a high frequency generated greater power than single stimuli or tetanic contractions. Larger muscles and circuitry improvements are expected to increase available power. An implanted, self-replenishing power source has the potential to augment implanted battery or transcutaneously powered electronic medical devices.

  10. Implantable optogenetic device with CMOS IC technology for simultaneous optical measurement and stimulation

    NASA Astrophysics Data System (ADS)

    Haruta, Makito; Kamiyama, Naoya; Nakajima, Shun; Motoyama, Mayumi; Kawahara, Mamiko; Ohta, Yasumi; Yamasaki, Atsushi; Takehara, Hiroaki; Noda, Toshihiko; Sasagawa, Kiyotaka; Ishikawa, Yasuyuki; Tokuda, Takashi; Hashimoto, Hitoshi; Ohta, Jun

    2017-05-01

    In this study, we have developed an implantable optogenetic device that can measure and stimulate neurons by an optical method based on CMOS IC technology. The device consist of a blue LED array for optically patterned stimulation, a CMOS image sensor for acquiring brain surface image, and eight green LEDs surrounding the CMOS image sensor for illumination. The blue LED array is placed on the CMOS image sensor. We implanted the device in the brain of a genetically modified mouse and successfully demonstrated the stimulation of neurons optically and simultaneously acquire intrinsic optical images of the brain surface using the image sensor. The integrated device can be used for simultaneously measuring and controlling neuronal activities in a living animal, which is important for the artificial control of brain functions.

  11. In vitro study of the electromagnetic interaction between wireless phones and an implantable neural stimulator.

    PubMed

    Grant, Hank; Heirman, Donald; Kuriger, Glenn; Ravindran, Murali Manohar

    2004-07-01

    Several clinical and laboratory studies have demonstrated electromagnetic interaction between implantable medical devices like pacemakers and cell phones being operated in close proximity. Those devices are largely now immune to phone interaction or procedures have been established to limit their interaction. The use of cell phones near people with implanted neural stimulators has not been studied. This research was initiated to investigate electromagnetic interaction between current cell phone technology and specific models of Cyberonics neural stimulators. Out of 1080 test runs conducted for this study, no interactions were observed, and it was concluded that the phone technologies examined in this study did not adversely affect the Cyberonics NeuroStar (Model 102) NeuroCybernetic Prosthesis (NCP) System. This article provides details on the experimental procedure that was used, which can also be used to test other neural stimulators and test technologies, and the results obtained. Copyright 2004 Wiley-Liss, Inc.

  12. The Codacs™ direct acoustic cochlear implant actuator: exploring alternative stimulation sites and their stimulation efficiency.

    PubMed

    Grossöhmichen, Martin; Salcher, Rolf; Kreipe, Hans-Heinrich; Lenarz, Thomas; Maier, Hannes

    2015-01-01

    This work assesses the efficiency of the Codacs system actuator (Cochlear Ltd., Sydney Australia) in different inner ear stimulation modalities. Originally the actuator was intended for direct perilymph stimulation after stapedotomy using a piston prosthesis. A possible alternative application is the stimulation of middle ear structures or the round window (RW). Here the perilymph stimulation with a K-piston through a stapes footplate (SFP) fenestration (N = 10) as well as stimulation of the stapes head (SH) with a Bell prosthesis (N = 9), SFP stimulation with an Omega/Aerial prosthesis (N = 8) and reverse RW stimulation (N = 10) were performed in cadaveric human temporal bones (TBs). Codacs actuator output is expressed as equivalent sound pressure level (eq. SPL) using RW and SFP displacement responses, measured by Laser Doppler velocimetry as reference. The axial actuator coupling force in stimulation of stapes and RW was adjusted to ~5 mN. The Bell prosthesis and Omega/Aerial prosthesis stimulation generated similar mean eq. SPLs (Bell: 127.5-141.8 eq. dB SPL; Omega/Aerial: 123.6-143.9 eq. dB SPL), being significantly more efficient than K-piston perilymph stimulation (108.6-131.6 eq. dB SPL) and RW stimulation (108.3-128.2 eq. dB SPL). Our results demonstrate that SH, SFP and RW are adequate alternative stimulation sites for the Codacs actuator using coupling prostheses and an axial coupling force of ~5 mN. Based on the eq. SPLs, all investigated methods were adequate for in vivo hearing aid applications, provided that experimental conditions including constant coupling force will be implemented.

  13. The Codacs™ Direct Acoustic Cochlear Implant Actuator: Exploring Alternative Stimulation Sites and Their Stimulation Efficiency

    PubMed Central

    Grossöhmichen, Martin; Salcher, Rolf; Kreipe, Hans-Heinrich; Lenarz, Thomas; Maier, Hannes

    2015-01-01

    This work assesses the efficiency of the Codacs system actuator (Cochlear Ltd., Sydney Australia) in different inner ear stimulation modalities. Originally the actuator was intended for direct perilymph stimulation after stapedotomy using a piston prosthesis. A possible alternative application is the stimulation of middle ear structures or the round window (RW). Here the perilymph stimulation with a K-piston through a stapes footplate (SFP) fenestration (N = 10) as well as stimulation of the stapes head (SH) with a Bell prosthesis (N = 9), SFP stimulation with an Omega/Aerial prosthesis (N = 8) and reverse RW stimulation (N = 10) were performed in cadaveric human temporal bones (TBs). Codacs actuator output is expressed as equivalent sound pressure level (eq. SPL) using RW and SFP displacement responses, measured by Laser Doppler velocimetry as reference. The axial actuator coupling force in stimulation of stapes and RW was adjusted to ~ 5 mN. The Bell prosthesis and Omega/Aerial prosthesis stimulation generated similar mean eq. SPLs (Bell: 127.5–141.8 eq. dB SPL; Omega/Aerial: 123.6–143.9 eq. dB SPL), being significantly more efficient than K-piston perilymph stimulation (108.6–131.6 eq. dB SPL) and RW stimulation (108.3–128.2 eq. dB SPL). Our results demonstrate that SH, SFP and RW are adequate alternative stimulation sites for the Codacs actuator using coupling prostheses and an axial coupling force of ~ 5 mN. Based on the eq. SPLs, all investigated methods were adequate for in vivo hearing aid applications, provided that experimental conditions including constant coupling force will be implemented. PMID:25785860

  14. A Single-Chip Full-Duplex High Speed Transceiver for Multi-Site Stimulating and Recording Neural Implants.

    PubMed

    Mirbozorgi, S Abdollah; Bahrami, Hadi; Sawan, Mohamad; Rusch, Leslie A; Gosselin, Benoit

    2016-06-01

    We present a novel, fully-integrated, low-power full-duplex transceiver (FDT) to support high-density and bidirectional neural interfacing applications (high-channel count stimulating and recording) with asymmetric data rates: higher rates are required for recording (uplink signals) than stimulation (downlink signals). The transmitter (TX) and receiver (RX) share a single antenna to reduce implant size and complexity. The TX uses impulse radio ultra-wide band (IR-UWB) based on an edge combining approach, and the RX uses a novel 2.4-GHz on-off keying (OOK) receiver. Proper isolation (>20 dB) between the TX and RX path is implemented 1) by shaping the transmitted pulses to fall within the unregulated UWB spectrum (3.1-7 GHz), and 2) by space-efficient filtering (avoiding a circulator or diplexer) of the downlink OOK spectrum in the RX low-noise amplifier. The UWB 3.1-7 GHz transmitter can use either OOK or binary phase shift keying (BPSK) modulation schemes. The proposed FDT provides dual band 500-Mbps TX uplink data rate and 100 Mbps RX downlink data rate, and it is fully integrated into standard TSMC 0.18- μm CMOS within a total size of 0.8 mm(2). The total measured power consumption is 10.4 mW in full duplex mode (5 mW at 100 Mbps for RX, and 5.4 mW at 500 Mbps or 10.8 pJ/bit for TX). Additionally, a 3-coil inductive link along with on-chip power management circuits allows to powering up the implantable transceiver wirelessly by delivering 25 mW extracted from a 13.56-MHz carrier signal, at a total efficiency of 41.6%.

  15. Stimulation rate reduction and auditory development in poorly performing cochlear implant users with auditory neuropathy.

    PubMed

    Pelosi, Stanley; Rivas, Alejandro; Haynes, David S; Bennett, Marc L; Labadie, Robert F; Hedley-Williams, Andrea; Wanna, George B

    2012-12-01

    Patients with auditory neuropathy spectrum disorder (ANSD) exhibit altered neural synchrony in response to auditory stimuli. It has been hypothesized that a slower rate of electrical stimulation in programming strategies for cochlear implant (CI) users with ANSD may enhance development of neural synchrony and speech perception abilities. Retrospective case series. Tertiary otologic practice. Twenty-two patients with ANSD underwent CI. Patients with complete postoperative audiometric data and at least 2 years of follow-up were included in further analysis. Thirteen patients patients met inclusion criteria. Five "poorly performing" CI recipients with ANSD who had not developed closed-set speech perception abilities despite at least 2 years of implant use underwent implant programming to lower the neural stimulation rate. Speech perception abilities over time using parent questionnaire, closed-set testing, and open-set measures. A high incidence of comorbid conditions was present in the poor performers, including cognitive delay (n = 2), motor delay (n = 3), and autism spectrum disorder (n = 1). The median time to rate slowing in 5 poor performers was 29 months after implant activation. Three of 5 patients achieved closed-set speech perception scores higher than 60% after 6 to 16 months of implant use at the slower rates. At last follow-up (median, 42 mo), no poor performer had yet achieved open-set speech perception abilities. Of all CI recipients with ANSD included in analysis, open-set speech perception abilities developed in 46% (6/13). In CI recipients with ANSD who demonstrate limited auditory skills development despite prolonged implant use, lowering the stimulation rate may facilitate acquisition of closed-set speech perception abilities. Further efforts on the study of programming parameters in ANSD patients with CIs are necessary to maximize auditory development in this patient population.

  16. Transcutaneous electrical nerve stimulator trial may be used as a screening tool prior to spinal cord stimulator implantation.

    PubMed

    Mathew, Leena; Winfree, Christopher; Miller-Saultz, Debra; Sonty, Nomita

    2010-08-01

    This is a prospective pilot study looking at the utility of Transcutaneous Electrical Nerve Stimulator (TENS) trial as a screening tool prior to spinal cord stimulator (SCS) implant to identify patients who may fail a SCS trial. The accepted screening test prior to a permanent SCS implant is a SCS trial. Patients may fail the SCS trial due to several causes of which one is the inability to tolerate stimulation induced paresthesias. Twenty five patients scheduled for a SCS trial for the treatment of refractory pain secondary to Failed Back surgery syndrome underwent a TENS trial and psychological evaluation by personnel uninvolved in the SCS trial. Data was collected by personnel not involved in the SCS trial or permanent placement. Twenty patients completed the study. Data collected included area of coverage, paresthesia tolerance, pain and anxiety measured on a VAS scale. Comparability between the groups were analyzed using Pearson's correlation, Fisher Exact test and simple regression analysis. We noted a significant correlation between ability to tolerate TENS and SCS induced paresthesias. Statistically significant correlation was also noted between pre SCS trial anxiety score and high pain score during SCS trial. We conclude that there is potential applicability of a TENS trial as a non invasive screening tool which may promote cost effectiveness and decrease unnecessary procedural risks to the patient by avoiding SCS trial in select patients.

  17. Preclinical Evaluation of Poly(HEMA-co-acrylamide) Hydrogels Encapsulating Glucose Oxidase and Palladium Benzoporphyrin as Fully Implantable Glucose Sensors

    PubMed Central

    Unruh, Rachel M.; Roberts, Jason R.; Nichols, Scott P.; Gamsey, Soya; Wisniewski, Natalie A.; McShane, Michael J.

    2015-01-01

    Background: Continuous glucose monitors (CGMs) require percutaneous wire probes to monitor glucose. Sensors based on luminescent hydrogels are being explored as fully implantable alternatives to traditional CGMs. Our previous work investigated hydrogel matrices functionalized with enzymes and oxygen-quenched phosphors, demonstrating sensitivity to glucose, range of response, and biofouling strongly depend on the matrix material. Here, we further investigate the effect of matrix composition on overall performance in vitro and in vivo. Methods: Sensors based on three hydrogels, a poly(2-hydroxyethyl methacrylate) (pHEMA) homopolymer and 2 poly(2-hydroxyethyl methacrylate-co-acrylamide) (pHEMA-co-AAm) copolymers, were compared. These were used to entrap glucose oxidase (GOx), catalase, and an oxygen-sensitive benzoporphyrin phosphor. All sensor formulations were evaluated for glucose response and stability at physiological temperatures. Selected sensors were then evaluated as implanted sensors in a porcine model challenged with glucose and insulin. The animal protocol used in this study was approved by an IACUC committee at Texas A&M University. Results: PHEMA-co-AAm copolymer hydrogels (75:25 HEMA:AAm) yielded the most even GOx and dye dispersion throughout the hydrogel matrix and best preserved GOx apparent activity. In response to in vitro glucose challenges, this formulation exhibited a dynamic range of 12-167 mg/dL, a sensitivity of 1.44 ± 0.46 µs/(mg/dL), and tracked closely with reference capillary blood glucose values in vivo. Conclusions: The hydrogel-based sensors exhibited excellent sensitivity and sufficiently rapid response to the glucose levels achieved in vivo, proving feasibility of these materials for use in real-time glucose tracking. Extending the dynamic range and assessing long-term effects in vivo are ongoing efforts. PMID:26085565

  18. Stimulated emission via electron-hole plasma recombination in fully strained single InGaN/GaN heterostructures

    NASA Astrophysics Data System (ADS)

    Minj, A.; Romero, M. F.; Wang, Y.; Tuna, Ö.; Feneberg, M.; Goldhahn, R.; Schmerber, G.; Ruterana, P.; Giesen, C.; Heuken, M.

    2016-11-01

    The optical properties of fully coherently grown single InGaN/GaN heterostructures for 12 stimulated emission by electron-hole plasma recombination was observed for temperatures up to 295 K.

  19. Chronic implantation of newly developed suprachoroidal-transretinal stimulation prosthesis in dogs.

    PubMed

    Morimoto, Takeshi; Kamei, Motohiro; Nishida, Kentaro; Sakaguchi, Hirokazu; Kanda, Hiroyuki; Ikuno, Yasushi; Kishima, Haruhiko; Maruo, Tomoyuki; Konoma, Kunihiko; Ozawa, Motoki; Nishida, Kohji; Fujikado, Takashi

    2011-08-29

    To investigate the feasibility of implanting a newly developed suprachoroidal-transretinal stimulation (STS) prosthesis in dogs and to determine its biocompatibility and stability over a 3-month period. The STS prosthesis system consisted of an array of 49 electrodes (nine were active), an intravitreal return electrode, and an extraocular microstimulator. The 49-electrode array was implanted into a scleral pocket of each of three healthy beagle dogs. Color fundus photography, fluorescein angiography, electroretinography, and functional testing of the STS system were performed postoperatively. The dogs were euthanatized 3 months after the implantation, and the retinas were evaluated histologically. All the prostheses were successfully implanted without complications, and no serious complications occurred during the 3-month postoperative period. The fixation of the implant was stable throughout the experimental period. Fluorescein angiography showed that the entire retina, including the area on the electrode array, remained well perfused without intraocular inflammation. Electroretinograms recorded from the eyes with the prosthesis did not differ significantly from those recorded from control eyes. Functional testing of the STS system showed that this system performed well for the 3-month experimental period. Histologic evaluations showed good preservation of the retina over the electrode array. Implantation of a newly developed STS retinal prosthesis into a scleral pocket of beagle dogs is surgically feasible and can be performed without significant damage to the retina or the animal. The biocompatibility and stability of the system were good for the 3-month observation period.

  20. Duplex communicable implanted antenna for magnetic direct feeding method: Functional electrical stimulation

    NASA Astrophysics Data System (ADS)

    Kato, Kentaro; Matsuki, Hidetoshi; Sato, Fumihiro; Satoh, Tadakuni; Handa, Nobuyasu

    2009-04-01

    Functional electrical stimulation (FES) is the therapy used for the rehabilitation of lost movement function by applying electrical stimulation (ES) to paralyzed extremities. To realize ES, we adapted the implanted direct feeding method (DFM). In this method, small implanted stimulators are placed under the skin at a depth of 10-20 mm and stimulus energy and signals for controlling devices are applied to them by a mounted system using magnetic coupling. This method has the merits of having no percutaneous points and high-precision stimulation. However, since the mounted system and implanted elements are separated, it is necessary to add feedback information from inside the body to confirm the system operation for safety therapy or to rehabilitate motor function smoothly. Satisfying both restrictions, we propose the magnetic connective dual resonance (MCDR) antenna, which has two resonance circuits. Adding the LC serial circuit to the LC parallel circuit gives the sending function. In this paper, we report the principle of the MCDR antenna and verify its duplex communication ability through communication experiment. This antenna enables DFM of FES to rehabilitate more complex movements.

  1. Early Bimodal Stimulation Benefits Language Acquisition for Children With Cochlear Implants.

    PubMed

    Moberly, Aaron C; Lowenstein, Joanna H; Nittrouer, Susan

    2016-01-01

    Adding a low-frequency acoustic signal to the cochlear implant (CI) signal (i.e., bimodal stimulation) for a period of time early in life improves language acquisition. Children must acquire sensitivity to the phonemic units of language to develop most language-related skills, including expressive vocabulary, working memory, and reading. Acquiring sensitivity to phonemic structure depends largely on having refined spectral (frequency) representations available in the signal, which does not happen with CIs alone. Combining the low-frequency acoustic signal available through hearing aids with the CI signal can enhance signal quality. A period with this bimodal stimulation has been shown to improve language skills in very young children. This study examined whether these benefits persist into childhood. Data were examined for 48 children with CIs implanted under age 3 years, participating in a longitudinal study. All children wore hearing aids before receiving a CI, but upon receiving a first CI, 24 children had at least 1 year of bimodal stimulation (Bimodal group), and 24 children had only electric stimulation subsequent to implantation (CI-only group). Measures of phonemic awareness were obtained at second and fourth grades, along with measures of expressive vocabulary, working memory, and reading. Children in the Bimodal group generally performed better on measures of phonemic awareness, and that advantage was reflected in other language measures. Having even a brief period of time early in life with combined electric-acoustic input provides benefits to language learning into childhood, likely because of the enhancement in spectral representations provided.

  2. Remote power delivery for hybrid integrated bio-implantable electrical stimulation system

    NASA Astrophysics Data System (ADS)

    Gaddam, Venkat R.; Yernagula, Jagadish; Anantha, Raghavendra R.; Kona, Satish; Kopparthi, Sunitha; Chamakura, A.; Ajmera, Pratul K.; Srivastava, Ashok

    2005-05-01

    In this work, a remote power delivery system to charge rechargeable batteries that power a Bio-implanted Electrical Stimulation System (BESS) is first described. A loosely coupled inductive transmitter and receiver system has been used to power a bio-implanted gastric pacer. The receiver coil, rechargeable batteries, battery charging chip and the chip containing stimulation circuitry form a hybrid integrated microsystem. A design methodology for this Remote Power Delivery System (RPDS) is proposed. The BESS chip is also designed for electrical stimulation. It is a special IC chip which takes power from the rechargeable batteries and provides output pulses of 9.9 V amplitude at a frequency of 103 Hz and a duty cycle of 5%. The BESS chip contains a battery switching circuit and a pulse conditioning circuit which first provides pulses of 3 V amplitude. It also has an internal charge pump and a pulse booster circuit to boost the pulse amplitude to 9.9 V. Hybrid packaging is considered for integrating the implantable electrical stimulation circuitry and the remote power delivery system. Screen printed interconnects are used to integrate the BESS chip, the battery charging chip, discrete components and the receiver circuit of the RPDS.

  3. Drivers and Risk Factors of Unplanned 30-Day Readmission Following Spinal Cord Stimulator Implantation.

    PubMed

    Elsamadicy, Aladine A; Sergesketter, Amanda; Ren, Xinru; Mohammed Qasim Hussaini, Syed; Laarakker, Avra; Rahimpour, Shervin; Ejikeme, Tiffany; Yang, Siyun; Pagadala, Promila; Parente, Beth; Xie, Jichun; Lad, Shivanand P

    2017-09-29

    Unplanned 30-day readmission rates contribute significantly to growing national healthcare expenditures. Drivers of unplanned 30-day readmission after spinal cord stimulator (SCS) implantation are relatively unknown. The aim of this study was to determine drivers of 30-day unplanned readmission following SCS implantation. The National Readmission Database was queried to identify all patients who underwent SCS implantation for the 2013 calendar year. Patients were grouped by readmission status, "No Readmission" and "Unplanned 30-day Readmission." Patient demographics and comorbidities were collected for each patient. The primary outcome of interest was the rate of unplanned 30-day readmissions and associated driving factors. A multivariate analysis was used to determine independent predictors of unplanned 30-day readmission after SCS implantation. We identified 1521 patients who underwent SCS implantation, with 113 (7.4%) experiencing an unplanned readmission within 30 days. Baseline patient demographics, comorbidities, and hospital characteristics were similar between both cohorts. The three main drivers for 30-day readmission after SCS implantation include: 1) infection (not related to SCS device), 2) infection due to device (limited to only hardware infection), and 3) mechanical complication of SCS device. Furthermore, obesity was found to be an independent predictor of 30-day readmission (OR: 1.86, p = 0.008). Our study suggests that infectious and mechanical complications are the primary drivers of unplanned 30-day readmission after SCS implantation, with obesity as an independent predictor of unplanned readmission. Given the technological advancements in SCS, repeated studies are necessary to identify factors associated with unplanned 30-day readmission rates after SCS implantation to improve patient outcomes and reduce associated costs. © 2017 International Neuromodulation Society.

  4. Wireless charing pillow for a fully implantable hearing aid: Design of a circular array coil based on finite element analysis for reducing magnetic weak zones.

    PubMed

    Lim, Hyung-Gyu; Kim, Jong Hoon; Shin, Dong Ho; Woo, Seong Tak; Seong, Ki Woong; Lee, Jyung Hyun; Kim, Myoung Nam; Wei, Qun; Cho, Jin-Ho

    2015-01-01

    Many types of fully implantable hearing aids have been developed. Most of these devices are implanted behind the ear. To maintain the implanted device for a long period of time, a rechargeable battery and wireless power transmission are used. Because inductive coupling is the most renowned method for wireless power transmission, many types of fully implantable hearing aids are transcutaneously powered using inductively coupled coils. Some patients with an implantable hearing aid require a method for conveniently charging their hearing aid while they are resting or sleeping. To address this need, a wireless charging pillow has been developed that employs a circular array coil as one of its primary parts. In this device, all primary coils are simultaneously driven to maintain an effective charging area regardless of head motion. In this case, however, there may be a magnetic weak zone that cannot be charged at the specific secondary coil's location on the array coil. In this study, assuming that a maximum charging distance is 4 cm, a circular array coil-serving as a primary part of the charging pillow-was designed using finite element analysis. Based on experimental results, the proposed device can charge an implantable hearing aid without a magnetic weak zone within 4 cm of the perpendicular distance between the primary and secondary coils.

  5. Cosmetic posterior implant of internal pulse generators in deep brain stimulation procedures: technical report.

    PubMed

    Messina, Giuseppe; Rizzi, Michele; Dones, Ivano; Franzini, Angelo

    2014-12-01

    The study aims to describe a novel cosmetic implantation technique of internal pulse generators (IPGs) for deep brain stimulation (DBS) electrodes. Thirty Parkinson patients during the interval 2001 to 2012 underwent posterior (cervical, dorsal, and lateral subcostal ) subcutaneous implantation of DBS connection cables and IPGs in the prone position. No surgical complications occurred in any of the patients who underwent this procedure; all of the patients reported a high level of satisfaction with the cosmetic results due to the excellent concealment of the implanted devices. Although this procedure is a little more time consuming compared with the conventional procedure, it is safe and leads to very good cosmetic results in DBS patients, which has significant benefits from the standpoint of social and work activities. © 2014 International Neuromodulation Society.

  6. Neural signal processing and closed-loop control algorithm design for an implanted neural recording and stimulation system.

    PubMed

    Hamilton, Lei; McConley, Marc; Angermueller, Kai; Goldberg, David; Corba, Massimiliano; Kim, Louis; Moran, James; Parks, Philip D; Sang Chin; Widge, Alik S; Dougherty, Darin D; Eskandar, Emad N

    2015-08-01

    A fully autonomous intracranial device is built to continually record neural activities in different parts of the brain, process these sampled signals, decode features that correlate to behaviors and neuropsychiatric states, and use these features to deliver brain stimulation in a closed-loop fashion. In this paper, we describe the sampling and stimulation aspects of such a device. We first describe the signal processing algorithms of two unsupervised spike sorting methods. Next, we describe the LFP time-frequency analysis and feature derivation from the two spike sorting methods. Spike sorting includes a novel approach to constructing a dictionary learning algorithm in a Compressed Sensing (CS) framework. We present a joint prediction scheme to determine the class of neural spikes in the dictionary learning framework; and, the second approach is a modified OSort algorithm which is implemented in a distributed system optimized for power efficiency. Furthermore, sorted spikes and time-frequency analysis of LFP signals can be used to generate derived features (including cross-frequency coupling, spike-field coupling). We then show how these derived features can be used in the design and development of novel decode and closed-loop control algorithms that are optimized to apply deep brain stimulation based on a patient's neuropsychiatric state. For the control algorithm, we define the state vector as representative of a patient's impulsivity, avoidance, inhibition, etc. Controller parameters are optimized to apply stimulation based on the state vector's current state as well as its historical values. The overall algorithm and software design for our implantable neural recording and stimulation system uses an innovative, adaptable, and reprogrammable architecture that enables advancement of the state-of-the-art in closed-loop neural control while also meeting the challenges of system power constraints and concurrent development with ongoing scientific research designed

  7. Selective Neuronal Activation by Cochlear Implant Stimulation in Auditory Cortex of Awake Primate.

    PubMed

    Johnson, Luke A; Della Santina, Charles C; Wang, Xiaoqin

    2016-12-07

    Despite the success of cochlear implants (CIs) in human populations, most users perform poorly in noisy environments and music and tonal language perception. How CI devices engage the brain at the single neuron level has remained largely unknown, in particular in the primate brain. By comparing neuronal responses with acoustic and CI stimulation in marmoset monkeys unilaterally implanted with a CI electrode array, we discovered that CI stimulation was surprisingly ineffective at activating many neurons in auditory cortex, particularly in the hemisphere ipsilateral to the CI. Further analyses revealed that the CI-nonresponsive neurons were narrowly tuned to frequency and sound level when probed with acoustic stimuli; such neurons likely play a role in perceptual behaviors requiring fine frequency and level discrimination, tasks that CI users find especially challenging. These findings suggest potential deficits in central auditory processing of CI stimulation and provide important insights into factors responsible for poor CI user performance in a wide range of perceptual tasks. The cochlear implant (CI) is the most successful neural prosthetic device to date and has restored hearing in hundreds of thousands of deaf individuals worldwide. However, despite its huge successes, CI users still face many perceptual limitations, and the brain mechanisms involved in hearing through CI devices remain poorly understood. By directly comparing single-neuron responses to acoustic and CI stimulation in auditory cortex of awake marmoset monkeys, we discovered that neurons unresponsive to CI stimulation were sharply tuned to frequency and sound level. Our results point out a major deficit in central auditory processing of CI stimulation and provide important insights into mechanisms underlying the poor CI user performance in a wide range of perceptual tasks. Copyright © 2016 the authors 0270-6474/16/3612468-17$15.00/0.

  8. Assessment of responses to cochlear implant stimulation at different levels of the auditory pathway

    PubMed Central

    Abbas, Paul J.; Brown, Carolyn J.

    2014-01-01

    This paper reviews characteristics of both the electrically evoked compound action potential (ECAP) and analogous measures of cortically evoked responses (CAEP) to electrical stimulation in cochlear implant users. Specific comparisons are made between the two levels of processing for measures of threshold, growth of responses with increasing stimulus level, changes in stimulation electrode and, finally, in temporal response properties. The results are interpreted in a context that ECAPs primarily reflect the characteristics of the electrode-neural interface for an individual ear. CAEPs clearly are dependent on those peripheral responses but also reflect differences in central processing among individual implant users. The potential applicability of combined measures in clinical situations is discussed. PMID:25445817

  9. Progress in implantable gastric stimulation: summary of results of the European multi-center study.

    PubMed

    De Luca, Maurizio; Segato, Gianni; Busetto, Luca; Favretti, Franco; Aigner, Franz; Weiss, Helmut; de Gheldere, Charles; Gaggiotti, Giorgio; Himpens, Jacques; Limao, Jorge; Scheyer, Matthias; Toppino, Mauro; Zurmeyer, Ernst L; Bottani, Giorgio; Penthaler, Heinrich

    2004-09-01

    The Implantable Gastric Stimulator (IGS(R)), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. The LOSS (Laparoscopic Obesity Stimulation Survey) is a prospective non-randomized trial which enrolled 69 patients involving 11 investigator centers in 5 European Countries. In 19 patients, ghrelin was analyzed. Between January 2002 and December 2003, 69 patients (F/M 49/20), mean age 41 years (18-65) underwent IGS implantation. Mean BMI was 41 (35-57), mean weight 115.0 kg (65-160) and mean excess weight (EW) 52 kg (13-89). The IGS was actived 30 days after implantation. In a subset of 19 patients studied further, 0, 6, and 12 months appetite and satiety score were evaluated and 0 and 6 months ghrelin profile was analyzed. The mean +/- standard error %EWL was: 8.6+/-1.8 at 1 month, 15.8+/-2.3 at 3 months, 17.8+/-2.6 at 6 months, 21.0+/-3.5 at 10 months, and 21.0+/-5.0 at 15 months. There were no intraoperative surgical or long-term complications. 7 intra-operative gastric penetrations occurred, observed by gastroscopy, without sequelae. 1 patient required a reoperation to remove a retained lead needle. In the subset of 19 patients, appetite was reduced and post-prandial and inter-prandial satiety was increased after IGS implantation. In the 19 patients, despite weight reduction, ghrelin did not increase. IGS can be implanted laparoscopically with minimal perioperative complications. Appetite is reduced and satiety is increased after the implantation. Ghrelin levels could be one of the mechanisms explaining weight loss and weight maintenance in IGS patients. If weight loss is maintained, IGS could be considered a good option for selected patients.

  10. Effects of stimulation rate, mode and level on modulation detection by cochlear implant users.

    PubMed

    Galvin, John J; Fu, Qian-Jie

    2005-09-01

    In cochlear implant (CI) patients, temporal processing is often poorest at low listening levels, making perception difficult for low-amplitude temporal cues that are important for consonant recognition and/or speech perception in noise. It remains unclear how speech processor parameters such as stimulation rate and stimulation mode may affect temporal processing, especially at low listening levels. The present study investigated the effects of these parameters on modulation detection by six CI users. Modulation detection thresholds (MDTs) were measured as functions of stimulation rate, mode, and level. Results show that for all stimulation rate and mode conditions, modulation sensitivity was poorest at quiet listening levels, consistent with results from previous studies. MDTs were better with the lower stimulation rate, especially for quiet-to-medium listening levels. Stimulation mode had no significant effect on MDTs. These results suggest that, although high stimulation rates may better encode temporal information and widen the electrode dynamic range, CI patients may not be able to access these enhanced temporal cues, especially at the lower portions of the dynamic range. Lower stimulation rates may provide better recognition of weak acoustic envelope information.

  11. [Abscess at the implant site following apical parodontitis. Hardware-related complications of deep brain stimulation].

    PubMed

    Sixel-Döring, F; Trenkwalder, C; Kappus, C; Hellwig, D

    2006-08-01

    Deep brain stimulation of the subthalamic nucleus is an important treatment option for advanced stages of idiopathic Parkinson's disease, leading to significant improvement of motor symptoms in suited patients. Hardware-related complications such as technical malfunction, skin erosion, and infections however cause patient discomfort and additional expense. The patient presented here suffered a putrid infection of the impulse generator site following only local dental treatment of apical parodontitis. Therefore, prophylactic systemic antibiotic treatment is recommended for patients with implanted deep brain stimulation devices in case of operations, dental procedures, or infectious disease.

  12. Sensitivity to pulse phase duration in cochlear implant listeners: Effects of stimulation mode

    PubMed Central

    Chatterjee, Monita; Kulkarni, Aditya M.

    2014-01-01

    The objective of this study was to investigate charge-integration at threshold by cochlear implant listeners using pulse train stimuli in different stimulation modes (monopolar, bipolar, tripolar). The results partially confirmed and extended the findings of previous studies conducted in animal models showing that charge-integration depends on the stimulation mode. The primary overall finding was that threshold vs pulse phase duration functions had steeper slopes in monopolar mode and shallower slopes in more spatially restricted modes. While the result was clear-cut in eight users of the Cochlear CorporationTM device, the findings with the six user of the Advanced BionicsTM device who participated were less consistent. It is likely that different stimulation modes excite different neuronal populations and/or sites of excitation on the same neuron (e.g., peripheral process vs central axon). These differences may influence not only charge integration but possibly also temporal dynamics at suprathreshold levels and with more speech-relevant stimuli. Given the present interest in focused stimulation modes, these results have implications for cochlear implant speech processor design and protocols used to map acoustic amplitude to electric stimulation parameters. PMID:25096116

  13. Multicolumn spinal cord stimulation lead implantation using an optic transligamentar minimally invasive technique.

    PubMed

    Rigoard, Philippe; Luong, Anh Tran; Delmotte, Alexandre; Raaholt, Mille; Roulaud, Manuel; Monlezun, Olivier; Triphose, Audrey; Guetarni, Farid; Brugière, Benjamin; Misbert, Lorraine; Diallo, Bakari; Bataille, Benoit

    2013-09-01

    A new generation of neurostimulation surgical leads is used to increase the success of spinal cord stimulation in difficult-to-treat indications such as failed back surgery syndrome. Minimal access spinal technologies (MASTs) have previously been used for surgical lead implantation. However, only a unilateral approach was possible, causing difficulties for median lead placement, and not always preventing laminectomy. A recent MAST technique was used to implant spinal cord stimulation leads without these limitations. To describe the MAST technique used in a pilot study. Twenty-four consecutive patients were implanted with a multicolumn surgical lead for refractory chronic back and leg pain by using the optic transligamentar MAST technique. The MAST technique allowed median lead placement, facilitated visualization of the spine, and permitted transligamentar insertion that minimized scarring and muscle damage. No technique-related adverse events or lead revisions were reported. Use of a MAST approach could be useful in safe implantation of multicolumn surgical leads in difficult-to-treat, refractory lower back pain conditions such as failed back surgery syndrome.

  14. Characteristics of infections in patients undergoing staged implantation for sacral nerve stimulation.

    PubMed

    Guralnick, Michael L; Benouni, Saraleen; O'Connor, R Corey; Edmiston, Charles

    2007-06-01

    To review clinical and surgical factors in patients who have undergone staged sacral nerve stimulator implantation and to determine whether there are any identifiable risk factors for infection. A retrospective chart review was performed on 76 consecutive patients undergoing staged implantation for sacral nerve stimulation for voiding dysfunction. Patients with postprocedural wound infections (after Stage 1 or Stage 2) were compared with those without infections with regard to demographic factors and surgical characteristics, such as operative time and duration of exposed lead wire. Organisms cultured were also documented. Lead infection occurred in 9 of 76 patients (12%). All cultures grew Staphylococcus aureus. Of 9 patients with lead infection, 6 had organisms sensitive to their perioperative antibiotic. Forty-five patients had an implantable pulse generator implanted, and 5 infections occurred (11%). Four cultures grew S. aureus (all sensitive to the perioperative antibiotic given), whereas one grew Pseudomonas. The only significant difference in clinical/surgical characteristics between infected and noninfected patients was a longer operative time for Stage 2 in infected patients. In addition, 3 patients with infection had one or more known risk factors for wound infection (steroid use, severe psoriasis, recurrent skin abscess). Apart from known risk factors for surgical wound infections, the only variable we could identify that might increase the risk for infection is a longer operative time for Stage 2. S. aureus was the organism most commonly cultured. Often it was sensitive to the perioperative antibiotic prophylaxis.

  15. Intraorbital implantation of a stimulating electrode for an optic nerve visual prosthesis. Case report.

    PubMed

    Brelén, Mårten E; De Potter, Patrick; Gersdorff, Michel; Cosnard, Guy; Veraart, Claude; Delbeke, Jean

    2006-04-01

    Research into visual prosthetics is expected to revolutionize the treatment of blind patients with incurable outer retinal degenerative disease. Substantial evidence shows that useful visual sensations can be produced by controlled electrical stimulation of the optic nerve. To make the optic nerve visual prosthesis more acceptable, implantation techniques safer and less invasive than those previously used have been developed. A medial transconjunctival approach is now used to implant a stimulating electrode around the intraorbital section of the optic nerve. This new technique allows sufficient exposure of the nerve after detaching only one rectus muscle and performing a lateral canthotomy. Previously, an electrode was implanted in the intracranial part of the optic nerve, which required more invasive surgery. The new technique was first developed in cadavers and in patients undergoing eye enucleations. Finally, a 68-year-old blind man suffering from retinitis pigmentosa underwent long-term implantation. In this case report the authors describe the technique and outline some of the challenges involved.

  16. Inappropriate implantable cardioverter defibrillator shock from a transcutaneous muscle stimulation device therapy.

    PubMed

    Siu, Chung-Wah; Tse, Hung-Fat; Lau, Chu-Pak

    2005-06-01

    Inappropriate shock from implantable cardioverter defibrillator (ICD) may result from external electromagnetic interference (EMI), especially for unipolar ventricle sensing. Previous case reports and small in-vitro safety study suggested that endocardial bipolar lead system may be immune from EMI resulting from transcutaneous electrical neuromuscle stimulation (TENS) therapy. This report presents an unusual case of inappropriate discharge in a patient with ICD of endocardial bipolar lead system, receiving TENS from a commercially available device.

  17. Finite difference time domain (FDTD) modeling of implanted deep brain stimulation electrodes and brain tissue.

    PubMed

    Gabran, S R I; Saad, J H; Salama, M M A; Mansour, R R

    2009-01-01

    This paper demonstrates the electromagnetic modeling and simulation of an implanted Medtronic deep brain stimulation (DBS) electrode using finite difference time domain (FDTD). The model is developed using Empire XCcel and represents the electrode surrounded with brain tissue assuming homogenous and isotropic medium. The model is created to study the parameters influencing the electric field distribution within the tissue in order to provide reference and benchmarking data for DBS and intra-cortical electrode development.

  18. Evolution of bladder contraction in course of time after implantation of a sacral anterior root stimulator.

    PubMed

    Egon, G; Colombel, P; Isambert, J L; Guerin, J; Barat, M

    1993-01-01

    We reviewed bladder contraction evolution after sacral anterior root stimulator implantation in thirty patients operated on from 1984 to 1991. Two patients underwent a complete denervation with a reinnervation within a maximal time of seventeen months. One patient underwent a lesion, like a neuropraxia with a complete recovery at four months. Five patients have undergone a partial denervation with a recovery of miction by neurostimulation within the time of eighteen months. In three patients, bladder contraction disappeared for various reasons.

  19. Chronic in-vivo testing of a 16-channel implantable wireless neural stimulator.

    PubMed

    Bredeson, Samuel; Kanneganti, Aswini; Deku, Felix; Cogan, Stuart; Romero-Ortega, Mario; Troyk, Philip

    2015-08-01

    Here, we report on chronic in-vivo testing of a 16-channel wireless floating microelectrode array (WFMA) in a rat sciatic nerve model. Muscle threshold currents, charge injection levels, and charge density were monitored for electrodes of two WFMA devices implanted into animal subjects over a five month period. This type of wireless stimulation device could eliminate problems associated with percutaneous connectors for a variety of neural prostheses and other medical devices.

  20. Simulated phase-locking stimulation: An improved signal processing strategy for cochlear implant

    NASA Astrophysics Data System (ADS)

    Wu, Xihong; Qu, Hongwei; Chen, Jing; Qu, Tianshu; Li, Liang

    2005-04-01

    Electrical stimulation of the auditory pathway produces different patterns of neural activity than those acoustically elicited. Traditional signal-processing strategies for cochlear implant usually do not utilize phase information contained in sound waves. Here, to evaluate potential advantages of introducing phase information to cochlear implant devices, a new signal processing method, so called simulated phase-locking stimulation (SPLS), was developed. To convey phase information of sound signals to the auditory nerve, electrical stimulation pulses were delivered at the zero-crossing time of sine waves of frequency bands after band-pass filtering and envelope extraction. The advantages of the SPLS method over the method of Continuous Interleaved Sampling (CIS+) were demonstrated by both objective evaluations, such as the spectro-temporal modulation index (STMI), and subjective evaluations, such as recognition of processed Chinese speech by normal hearing listeners under either noise (energetic) masking or speech (informational) masking conditions. The results suggest that the SPLS method is able to improve the function of cochlear devices by extracting and transferring fine-structure signals, which are important for cochlear-implant listeners to perceive tonal speech and music.

  1. Real-time visualization of magnetic flux densities for transcranial magnetic stimulation on commodity and fully immersive VR systems

    NASA Astrophysics Data System (ADS)

    Kalivarapu, Vijay K.; Serrate, Ciro; Hadimani, Ravi L.

    2017-05-01

    Transcranial Magnetic Stimulation (TMS) is a non-invasive procedure that uses time varying short pulses of magnetic fields to stimulate nerve cells in the brain. In this method, a magnetic field generator ("TMS coil") produces small electric fields in the region of the brain via electromagnetic induction. This technique can be used to excite or inhibit firing of neurons, which can then be used for treatment of various neurological disorders such as Parkinson's disease, stroke, migraine, and depression. It is however challenging to focus the induced electric field from TMS coils to smaller regions of the brain. Since electric and magnetic fields are governed by laws of electromagnetism, it is possible to numerically simulate and visualize these fields to accurately determine the site of maximum stimulation and also to develop TMS coils that can focus the fields on the targeted regions. However, current software to compute and visualize these fields are not real-time and can work for only one position/orientation of TMS coil, severely limiting their usage. This paper describes the development of an application that computes magnetic flux densities (h-fields) and visualizes their distribution for different TMS coil position/orientations in real-time using GPU shaders. The application is developed for desktop, commodity VR (HTC Vive), and fully immersive VR CAVETM systems, for use by researchers, scientists, and medical professionals to quickly and effectively view the distribution of h-fields from MRI brain scans.

  2. Clinical hemodynamic evaluation of patients implanted with a fully magnetically levitated left ventricular assist device (HeartMate 3).

    PubMed

    Uriel, Nir; Adatya, Sirtaz; Malý, Jiří; Kruse, Eric; Rodgers, Daniel; Heatley, Gerald; Herman, Aleš; Sood, Poornima; Berliner, Dominik; Bauersachs, Johann; Haverich, Axel; Želízko, Michael; Schmitto, Jan D; Netuka, Ivan

    2017-01-01

    The HeartMate 3 (HM3) is a Conformiteé Européenne (CE) mark-approved left ventricular assist device (LVAD) with a fully magnetically levitated rotor with features consisting of a wide range of operational speeds, wide flow paths and an artificial pulse. We performed a hemodynamic and echocardiographic evaluation of patients implanted with the HM3 LVAD to assess the speed range for optimal hemodynamic support. Sixteen HM3 patients underwent pump speed ramp tests with right heart catheterization (including central venous pressure [CVP], pulmonary artery pressure, pulmonary capillary wedge pressure [PCWP] and blood pressure [BP]) and 3-dimensional echocardiography (3DE). Data were recorded at up to 13 speed settings. Speed changes were in steps of 100 revolutions per minute (rpm), starting at 4,600 rpm and ramping up to 6,200 rpm. Mean original speed was 5,306 ± 148 rpm, with a majority of patients (10 of 16, 62.5%) having normal CVPs and PCWPs at their original rpm settings. Going from lowest to highest speeds, cardiac output improved at the rate of 0.08 ± 0.08 liter/min per 100 rpm (total change 1.25 ± 1.20 liters/min) and PCWP decreased at the rate of -0.48 ± 0.27 mm Hg per 100 rpm (total change -6.13 ± 3.72 mm Hg). CVP and systolic BP did not change significantly with changes in rpm. Left ventricular end-diastolic dimension (LVEDD) decreased at a rate of -0.15 ± 0.09 cm per 100 rpm. Number of rpm was adjusted based on test results to achieve CVPs and PCWPs as close to normal limits as possible, which was feasible in 13 (81.3%) patients. For the remaining 3 patients, medical management was pursued to optimize hemodynamic support. Hemodynamic normalization of pressures was achieved in the majority of patients implanted with the HM3 pump within a narrow speed range. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

  3. Implanted functional electrical stimulation: case report of a paraplegic patient with complete SCI after 9 years

    PubMed Central

    2014-01-01

    Backgrounds Experience of an implanted functional electrical stimulation neuroprosthesis (FES) associating 8-channel epimysial and 4-channel neural stimulations. The primary objective consisted in presenting clinical and technological experiences based on a 9-year follow-up of one patient implanted with this FES device. The secondary objective consisted in assessing resulting functional benefits. Methods One patient recruited in 1996 within the European Stand Up and Walk Project benefited from a 9-year follow-up with clinical and technological evaluations. Results The patient was still using the system nine years later making this a unique case, even when compared to other similar studies. The analysis of muscular response to FES underlined the great variability of stimulation thresholds evolution (−26% to +360%, mean +110%) and quality of the induced contraction. Three muscles out of five scored at least 4/5 on the Medical Research Council scale, all stimulated via neural pathways. The patient used the system once a week for 6 years, up to 2006, due to lack of use, the FES-induced muscular response worsened even though the implant was properly functioning, leading to significant decline in gait performances (best 3.45 m/s on 2.9 m), due to muscle fatigue and loss of muscle mass. Conclusion Two major issues arise: first the importance of muscle fatigue, underlining the relevance of muscle strength training, and second technological hurdles raising up the question of neural vs. epimysial FES. This advanced technology proves the concept of restoring lower limb motor functions in patients with spinal cord injury. The main features of the stimulation device remain stable even after long periods of inactivity, yet there is a real need for close clinical and technological monitoring. PMID:24564879

  4. High-resolution electrical stimulation of primate retina for epiretinal implant design

    PubMed Central

    Sekirnjak, Chris; Hottowy, Pawel; Sher, Alexander; Dabrowski, Wladyslaw; Litke, A. M.; Chichilnisky, E. J.

    2009-01-01

    The development of retinal implants for the blind depends crucially on understanding how neurons in the retina respond to electrical stimulation. This study used multi-electrode arrays to stimulate ganglion cells in the peripheral macaque retina, which is very similar to the human retina. Analysis was restricted to parasol cells, which form one of the major high-resolution visual pathways in primates. Individual cells were characterized using visual stimuli, and subsequently targeted for electrical stimulation using electrodes 9-15 microns in diameter. Results were accumulated across 16 ON and 9 OFF parasol cells. At threshold, all cells responded to biphasic electrical pulses 0.05-0.1 ms in duration by firing a single spike with latency lower than 0.35 ms. The average threshold charge density was 0.050 ± 0.005 mC/cm2, significantly below established safety limits for platinum electrodes. ON and OFF ganglion cells were stimulated with similar efficacy. Repetitive stimulation elicited spikes within a 0.1 ms time window, indicating that the high temporal precision necessary for spike-by-spike stimulation can be achieved in primate retina. Spatial analysis of observed thresholds suggests that electrical activation occurred near the axon hillock, and that dendrites contributed little. Finally, stimulation of a single parasol cell produced little or no activation of other cells in the ON and OFF parasol cell mosaics. The low-threshold, temporally precise, and spatially specific responses hold promise for the application of high density arrays of small electrodes in epiretinal implants. PMID:18434523

  5. Immediate motor effects of stimulation through electrodes implanted in the human globus pallidus.

    PubMed

    Ashby, P; Strafella, A; Dostrovsky, J O; Lozano, A; Lang, A E

    1998-01-01

    The immediate motor effects of stimulation through electrodes chronically implanted in the globus pallidus internus (GPI) were studied in 9 subjects with Parkinson's disease. Single stimuli (at >0.4 Hz) produced short latency facilitation of voluntarily activated contralateral muscles in all subjects. The latency and distribution of the facilitation, its probably monosynaptic nature, and the short chronaxie and refractory period of the activated neural elements suggest that the facilitation results from the direct excitation of the fast conducting corticospinal pathway. The facilitation of motoneurons followed high frequency (e.g. 200 Hz) stimulation without decrement and occurred at stimulus intensities well below those required to produce a visible muscle contraction. We conclude that, while there may be other effects, GPI stimulation through electrodes may activate the corticospinal tract, even when the stimuli are below the threshold for a visible muscle contraction, and that continuous stimulation may do so continuously. This may be an unwanted side effect, but possible therapeutic actions are considered. The reproducible short latency facilitation enabled us to estimate current spread from the quadripolar electrodes used for deep brain stimulation. When the current is sufficient to excite large myelinated fibers near one of the quadripolar electrodes, an additional 1-mA current will activate similar fibers at an additional distance of 1.8 mm with bipolar stimulation and at a distance of 5.7 mm with monopolar stimulation.

  6. Loading protocols and implant supported restorations proposed for the rehabilitation of partially and fully edentulous jaws. Camlog Foundation Consensus Report.

    PubMed

    Schwarz, Frank; Sanz-Martín, Ignacio; Kern, Jaana-Sophia; Taylor, Thomas; Schaer, Alex; Wolfart, Stefan; Sanz, Mariano

    2016-08-01

    The aim of this consensus meeting was to assess whether immediate loading protocols achieve comparable clinical outcomes when compared to conventional loading protocols depending on the type of prosthetic restoration. In addition post-loading implant loss for implant supported prostheses in edentulous jaws was analyzed regarding a potential impact of implant location (maxilla vs. mandible), implant number per patient, type of prosthesis (removable vs. fixed), and type of attachment system (screw-retained, ball vs. bar vs. telescopic crown). Two comprehensive systematic reviews were prepared in advance of the meeting. Consensus statements, practical recommendations, and implications for future research were based on within group as well as plenary scrutinization and discussions of these systematic reviews. The survival rates are high for immediate loaded and conventional loaded implants, but immediate loading may impose a greater risk for implant failure. The estimated implant loss rate is influenced by the implant location, type of restoration, and implant number. Consistent reporting of clinical studies is necessary and high-quality studies are needed to confirm the present results. © 2016 The Authors. Clinical Oral Implants Research Published by John Wiley & Sons Ltd.

  7. The transtympanic promontory stimulation test in patients with auditory deprivation: correlations with electrical dynamics of cochlear implant and speech perception.

    PubMed

    Alfelasi, Mohammad; Piron, Jean Pierre; Mathiolon, Caroline; Lenel, Nadjmah; Mondain, Michel; Uziel, Alain; Venail, Frederic

    2013-05-01

    Transtympanic promontory stimulation test (TPST) has been suggested to be a useful tool in predicting postoperative outcomes in patients at risk of poor auditory neuron functioning, especially after a long auditory deprivation. However, only sparse data are available on this topic. This study aimed at showing correlations between the auditory nerve dynamic range, evaluated by TPST, the electrical dynamic range of the cochlear implant and speech perception outcome. We evaluated 65 patients with postlingual hearing loss and no residual hearing, implanted with a Nucleus CI24 cochlear implant device for at least 2 years and with a minimum of 17 active electrodes. Using the TPST, we measured the threshold for auditory perception (T-level) and the maximum acceptable level of stimulation (M-level) at stimulation frequencies of 50, 100 and 200 Hz. General linear regression was performed to correlate 1/speech perception, evaluated using the PBK test 1 year after surgery, and 2/cochlear implant electrical dynamic range, with the age at time of implantation, the duration of auditory deprivation, the etiology of the deafness, the duration of cochlear implant use and auditory nerve dynamic range. Postoperative speech perception outcome correlated with etiology, duration of auditory deprivation and implant use, and TPST at 100 and 200 Hz. The dynamic range of the cochlear implant map correlated with duration of auditory deprivation, speech perception outcome at 6 months and TPST at 100 and 200 Hz. TPST test can be used to predict functional outcome after cochlear implant surgery in difficult cases.

  8. The Sound Sensation of Apical Electric Stimulation in Cochlear Implant Recipients with Contralateral Residual Hearing

    PubMed Central

    Marozeau, Jeremy; McDermott, Hugh J.

    2012-01-01

    Background Studies using vocoders as acoustic simulators of cochlear implants have generally focused on simulation of speech understanding, gender recognition, or music appreciation. The aim of the present experiment was to study the auditory sensation perceived by cochlear implant (CI) recipients with steady electrical stimulation on the most-apical electrode. Methodology/Principal Findings Five unilateral CI users with contralateral residual hearing were asked to vary the parameters of an acoustic signal played to the non-implanted ear, in order to match its sensation to that of the electric stimulus. They also provided a rating of similarity between each acoustic sound they selected and the electric stimulus. On average across subjects, the sound rated as most similar was a complex signal with a concentration of energy around 523 Hz. This sound was inharmonic in 3 out of 5 subjects with a moderate, progressive increase in the spacing between the frequency components. Conclusions/Significance For these subjects, the sound sensation created by steady electric stimulation on the most-apical electrode was neither a white noise nor a pure tone, but a complex signal with a progressive increase in the spacing between the frequency components in 3 out of 5 subjects. Knowing whether the inharmonic nature of the sound was related to the fact that the non-implanted ear was impaired has to be explored in single-sided deafened patients with a contralateral CI. These results may be used in the future to better understand peripheral and central auditory processing in relation to cochlear implants. PMID:22723876

  9. [Benefit of Bimodal Stimulation with Cochlear Implant and Hearing Aid in Elderly Patients].

    PubMed

    Hinder, Dominik; Linder, Thomas E; Schlegel-Wagner, Christoph; Candreia, Claudia

    2017-07-01

    Cochlear implant (CI) surgery is the standard of care for postlingual deafness in adults. A hearing aid (HA) for the non-implanted ear is normally used if residual hearing is available. There is limited data on bimodal stimulation in elderly patients. We compare the outcome of bimodal stimulation and analyzed the correlation of bimodal benefit and residual hearing in elderly patients. 22 patients≥70 years were implanted with a single-sided CI from 2002 till 2014. 17 patients use a HA on the non-implanted ear (bimodal). In a retrospective chart review we analyzed the audiological benefit (pure tone average, speech recognition). Time to follow-up was 6 month to 12 years. The subjective benefit was assessed using a structured questionnaire. The speech recognition (monosyllabic word testing in quiet @ 65 dB SPL) showed a score of 61% in bimodal condition vs. 53% with CI alone (p=0.35). There was no statistically significant correlation between residual hearing in the lower frequencies (250 Hz, 500 Hz and 1 kHz) and bimodal benefit. Most elderly patients benefit from bimodal stimulation. In quiet and in comparison with CI alone, most patients showed some improvement in word recognition scores using bimodal fitting, and all of them were using the contralateral hearing aid all day long. Postlingual deafened elderly patients fitted with a unilateral CI require a short rehabilitation period. In case of contralateral hearing aid fitting, regular control of the hearing aid should not be overlooked. © Georg Thieme Verlag KG Stuttgart · New York.

  10. Electromagnetic interference of GSM mobile phones with the implantable deep brain stimulator, ITREL-III

    PubMed Central

    Kainz, Wolfgang; Alesch, François; Chan, Dulciana Dias

    2003-01-01

    Background The purpose was to investigate mobile phone interference with implantable deep brain stimulators by means of 10 different 900 Mega Hertz (MHz) and 10 different 1800 MHz GSM (Global System for Mobile Communications) mobile phones. Methods All tests were performed in vitro using a phantom especially developed for testing with deep brain stimulators. The phantom was filled with liquid phantom materials simulating brain and muscle tissue. All examinations were carried out inside an anechoic chamber on two implants of the same type of deep brain stimulator: ITREL-III from Medtronic Inc., USA. Results Despite a maximum transmitted peak power of mobile phones of 1 Watt (W) at 1800 MHz and 2 W at 900 MHz respectively, no influence on the ITREL-III was found. Neither the shape of the pulse form changed nor did single pulses fail. Tests with increased transmitted power using CW signals and broadband dipoles have shown that inhibition of the ITREL-III occurs at frequency dependent power levels which are below the emissions of GSM mobile phones. The ITREL-III is essentially more sensitive at 1800 MHz than at 900 MHz. Particularly the frequency range around 1500 MHz shows a very low interference threshold. Conclusion These investigations do not indicate a direct risk for ITREL-III patients using the tested GSM phones. Based on the interference levels found with CW signals, which are below the mobile phone emissions, we recommend similar precautions as for patients with cardiac pacemakers: 1. The phone should be used at the ear at the opposite side of the implant and 2. The patient should avoid carrying the phone close to the implant. PMID:12773204

  11. Indication of direct acoustical cochlea stimulation in comparison to cochlear implants.

    PubMed

    Kludt, Eugen; Büchner, Andreas; Schwab, Burkard; Lenarz, Thomas; Maier, Hannes

    2016-10-01

    The new implantable hearing system Codacs™ was designed to close the treatment gap between active middle ear implants and cochlear implants in cases of severe-to-profound mixed hearing loss. The Codacs™ actuator is attached to conventional stapes prosthesis during the implantation and thereby provides acoustical stimulation through a stapedotomy to the cochlea. Cochlear implants (CIs) on the other hand are an established treatment option for profoundly deaf patients including mixed hearing losses that are possible candidates for the Codacs™. In this retrospective study, we compared the clinical outcome of 25 patients with the Codacs™ (≥3 month post-activation) to 54 CI patients (two years post-activation) with comparable pre-operative bone conduction (BC) thresholds that were potential candidates for both categories of devices. The word recognition score (Freiburg monosyllables test) in quiet was significantly (p < 0.05) better in the Codacs™ than in the corresponding CI patients for average pre-operative bone conduction below 60 dB HL and equal in patients with a pre-operative BC PTA between 60 and 70 dB HL. Speech in noise intelligibility (HSM sentences test at +10 dB SNR) was significantly (p < 0.001) better in Codacs™ (80% median) than in CI patients (25% median) in all tested groups. Our results indicate for patients with sufficient cochlear reserve that speech intelligibility in noise with the Codacs™ hearing implant is significantly better than with a CI. Further, results in Codacs™ were better predictable, encouraging the extension of the indication to patients with less cochlear reserve than reported here.

  12. Parenting stress in parents of children with refractory epilepsy before and after vagus nerve stimulation implantation.

    PubMed

    Li, Sung-Tse; Chiu, Nan-Chang; Kuo, Yung-Ting; Shen, Ein-Yiao; Tsai, Pei-Chieh; Ho, Che-Sheng; Wu, Wen-Hsiang; Chen, Juei-Chao

    2017-05-17

    The purpose of this study was to evaluate parenting stress in parents of children with refractory epilepsy before and after their children received vagus nerve stimulation (VNS) implantation. Parents of children with refractory epilepsy completed the Parenting Stress Index (PSI) under a psychologist's assessment before and at least 12 months after their children received VNS implantation. The PSI questionnaire measures parenting stress in two domains; a parent domain with seven subscales, and a child domain with six. Age, gender, epilepsy comorbidity, VNS implantation date, seizure frequency, and anticonvulsant history before and after VNS implantation were obtained from reviews of medical charts. In total, 30 parents completed the first and follow-up PSI questionnaires. Seventeen of their children (56.7%) were boys. The children aged from 1 to 12 years (7.43 ± 3.59 years, mean ± SD). After VNS implantation, the mean total parenting stress scores decreased from 282.1 ± 38.0 to 272.4 ± 42.9. A significant decrease was found on the spouse subscale of the parent domain. For the parents of boys, the mean total parenting stress scores decreased significantly. The mean total parenting stress scores also decreased significantly for parents of epileptic children without autism and who did not taper off the number of different anticonvulsants used after VNS. VNS is an advisable choice to treat refractory epilepsy. Our study showed that 12 months or more after VNS implantation, seizure frequency and parenting stress typically decreased. However, in some special cases the parenting stress may increase, and external help may be required to support these patients and their parents. Copyright © 2017. Published by Elsevier B.V.

  13. Early Bimodal Stimulation Benefits Language Acquisition for Children with Cochlear Implants

    PubMed Central

    Moberly, Aaron C.; Lowenstein, Joanna H.; Nittrouer, Susan

    2015-01-01

    Hypothesis Adding a low-frequency acoustic signal to the cochlear implant (CI) signal (i.e., bimodal stimulation) for a period of time early in life improves language acquisition. Background Children must acquire sensitivity to the phonemic units of language to develop most language-related skills, including expressive vocabulary, working memory, and reading. Acquiring sensitivity to phonemic structure depends largely on having refined spectral (frequency) representations available in the signal, which does not happen with CIs alone. Combining the low-frequency acoustic signal available through hearing aids with the CI signal can enhance signal quality. A period with this bimodal stimulation has been shown to improve language skills in very young children. This study examined whether these benefits persist into childhood. Methods Data were examined for 48 children with CIs implanted under age 3 years, participating in a longitudinal study. All children wore hearing aids prior to receiving a CI, but upon receiving a first CI, 24 children had at least one year of bimodal stimulation (Bimodal group), and 24 children had only electric stimulation subsequent to implantation (CI-only group). Measures of phonemic awareness were obtained at second and fourth grade, along with measures of expressive vocabulary, working memory, and reading. Results Children in the Bimodal group generally performed better on measures of phonemic awareness, and that advantage was reflected in other language measures. Conclusions Having even a brief period of time early in life with combined electric-acoustic input provides benefits to language learning into childhood, likely due to the enhancement in spectral representations provided. PMID:26571408

  14. The perception of complex pitch in cochlear implants: A comparison of monopolar and tripolar stimulation.

    PubMed

    Fielden, Claire A; Kluk, Karolina; Boyle, Patrick J; McKay, Colette M

    2015-10-01

    Cochlear implant listeners typically perform poorly in tasks of complex pitch perception (e.g., musical pitch and voice pitch). One explanation is that wide current spread during implant activation creates channel interactions that may interfere with perception of temporal fundamental frequency information contained in the amplitude modulations within channels. Current focusing using a tripolar mode of stimulation has been proposed as a way of reducing channel interactions, minimising spread of excitation and potentially improving place and temporal pitch cues. The present study evaluated the effect of mode in a group of cochlear implant listeners on a pitch ranking task using male and female singing voices separated by either a half or a quarter octave. Results were variable across participants, but on average, pitch ranking was at chance level when the pitches were a quarter octave apart and improved when the difference was a half octave. No advantage was observed for tripolar over monopolar mode at either pitch interval, suggesting that previously published psychophysical advantages for focused modes may not translate into improvements in complex pitch ranking. Evaluation of the spectral centroid of the stimulation pattern, plus a lack of significant difference between male and female voices, suggested that participants may have had difficulty in accessing temporal pitch cues in either mode.

  15. Development of HEATHER for cochlear implant stimulation using a new modeling workflow.

    PubMed

    Tran, Phillip; Sue, Andrian; Wong, Paul; Li, Qing; Carter, Paul

    2015-02-01

    The current conduction pathways resulting from monopolar stimulation of the cochlear implant were studied by developing a human electroanatomical total head reconstruction (namely, HEATHER). HEATHER was created from serially sectioned images of the female Visible Human Project dataset to encompass a total of 12 different tissues, and included computer-aided design geometries of the cochlear implant. Since existing methods were unable to generate the required complexity for HEATHER, a new modeling workflow was proposed. The results of the finite-element analysis agree with the literature, showing that the injected current exits the cochlea via the modiolus (14%), the basal end of the cochlea (22%), and through the cochlear walls (64%). It was also found that, once leaving the cochlea, the current travels to the implant body via the cranial cavity or scalp. The modeling workflow proved to be robust and flexible, allowing for meshes to be generated with substantial user control. Furthermore, the workflow could easily be employed to create realistic anatomical models of the human head for different bioelectric applications, such as deep brain stimulation, electroencephalography, and other biophysical phenomena.

  16. Implantable Colonic Electrical Stimulation Improves Gastrointestinal Transit and Defecation in a Canine Constipation Model.

    PubMed

    Chen, Shuo; Li, Yanmei; Yao, Shukun; Zhang, Yanli; Liu, Liang; Guo, Xiaojuan; Chen, Wang; Chen, Yan; Du, Yuhui

    2016-01-01

    Colonic electrical stimulation (CES) may have a therapeutic potential for slow transit constipation (STC). This study aimed to evaluate the effects of implantable CES on gastrointestinal transit and defecation, and explore its mechanisms in a canine STC model. Two pairs of electrodes were implanted in each of the proximal colon and rectosigmoid junction (RSJ). Parameters were individualized according to the symptoms of the stimulated dogs. In the STC model, gastrointestinal transit and defecation were assessed to evaluate the effects of double-site CES, and of double-site CES combined with atropine or N-nitro-L-arginine (L-NNA) in a crossover design. Individualized parameters varied among the animals. The CES significantly shortened gastrointestinal transit time (GITT) and colonic transit time (CTT) compared with sham CES (p = 0.001 and p < 0.001, respectively). Compared with sham CES, the CES also exhibited significantly higher stool frequency and stool consistency score (p = 0.018 and p = 0.001, respectively). Co-treatment with atropine or L-NNA blocked the effects of CES on GITT, CTT, and stool consistency. The stool frequency increased by CES, however, only reduced by co-treatment with L-NNA. This double-site implantable CES can improve the gastrointestinal transit and defecation in a canine STC model, possibly by activating the cholinergic and nitrergic pathways. The CES mode used in this study may be proven feasible in treating STC. © 2015 International Neuromodulation Society.

  17. [CILAB--a PC-based laboratory speech processor for implementation and evaluation of new stimulation strategies for cochlear implants].

    PubMed

    Mitterbacher, A; Lampacher, P; Zierhofer, C; Hochmair, E

    2004-06-01

    CILab is a computer-based versatile laboratory system for the implementation and evaluation of innovative stimulation strategies for cochlear implants. In contrast to existing laboratory systems the entire signal processing from the input signal to the creation of the data word for the implant is effected with the aid of a personal computer (PC). This permits rapid implementation of new stimulation strategies or psycho-acoustic tests. Real-time audio processing is also possible by using the CILab as a cochlear implant speech processor. The laboratory system has been employed with success for the evaluation of new strategies and numerous psycho-acoustic tests.

  18. Variability in RF-induced heating of a deep brain stimulation implant across MR systems.

    PubMed

    Baker, Kenneth B; Tkach, Jean A; Phillips, Micheal D; Rezai, Ali R

    2006-12-01

    To compare the MRI-related heating per unit of specific absorption rate (SAR) profile of a conductive implant between two 1.5-Tesla/64 MHz MR systems using a transmit/receive (t/r) head coil configuration. Deep brain stimulation (DBS) leads were configured within a gel-filled phantom of the human head and torso. Temperature variation at each of four contacts of the bilaterally-placed leads was monitored using fluoroptic thermometry. MRI was performed using the t/r head coils of two different-generation 1.5-Tesla MR systems from the same manufacturer. Temperature changes were normalized to SAR values for the head (DeltaT/SAR-H), and the slope of this DeltaT/SAR-H by time relationship was compared between the two scanners. The DeltaT/SAR-H for the implant ranged from 3.5 to 5.5 times higher on one MR system as compared to the other (P < 0.01) depending on the measurement site. The findings support previous observations that console-reported SAR does not constitute a reliable index of heating for elongated, conductive implants, such as the DBS hardware system tested. In contrast to our previous findings using a t/r body coil, the data presented here reveal marked differences between two MR systems using t/r head coils (the coil configuration was consistent with the implant manufacturer's imaging guidelines). J. Magn. Reson. Imaging 2006. (c) 2006 Wiley-Liss, Inc.

  19. Enhanced tissue integration of implantable electrodes for sensing, and stimulation, via radio frequency glow discharge

    NASA Astrophysics Data System (ADS)

    O'Connor, Laurie M.

    Biopotential electrodes are conductive materials that convert electronic currents to or from ionic currents for sensing, and stimulating specific tissue sites for medical applications. Implanted electrodes become "walled off" by the foreign body tissue reactions producing poorly attached scar capsules dominated by surrounding dense collagenous lamellae and source fibroblasts which are electrically resistive. The conductive interstitial fluid that is typical between an electrode and the resistive capsule allows spurious current paths. The insulating layer increases the distance between the electrode and the target sites and poor attachment often results in electrode migration within the host tissue. This investigation tested the hypothesis that surface-energy modulation of electrodes, via Radio Frequency Glow Discharge Treatment (RFGDT), can improve the performance of tissue-implantable electrodes by reducing the foreign body tissue reaction and enhancing interfacial bonding between the tissue and electrode material. Previously published findings were reproduced in a pilot study of explanted reference grade medical-grade methyl silicone (PDMS) and commercially pure titanium (cpTi) materials and their tissue capsules from 30-day subcutaneous exposures in Balb/C mice. The low-critical surface tension PDMS produced thick, dense, poorly attached scar capsules while the higher-surface-energy commercially pure titanium (cpTi) produced more cellular and strongly attached tissue layers difficult to delaminate from the biomaterial. For the main body of work, cpTi, capacitor-grade Tantalum (Ta), and synthetic heart valve-quality Pyrolytic Carbon (PyC) were evaluated, representative of potential high-surface-energy implant electrode materials. Their surface characteristics were determined as-manufactured and after Radio Frequency Glow Discharge Treatment (RFGDT) by Critical Surface Tension (CST) measurement, Scanning Electron Microscopy (SEM), Energy Dispersive X

  20. Clinical safety of brain magnetic resonance imaging with implanted deep brain stimulation hardware: large case series and review of the literature.

    PubMed

    Zrinzo, Ludvic; Yoshida, Fumiaki; Hariz, Marwan I; Thornton, John; Foltynie, Thomas; Yousry, Tarek A; Limousin, Patricia

    2011-01-01

    Over 75,000 patients have undergone deep brain stimulation (DBS) procedures worldwide. Magnetic resonance imaging (MRI) is an important clinical and research tool in analyzing electrode location, documenting postoperative complications, and investigating novel symptoms in DBS patients. Functional MRI may shed light on the mechanism of action of DBS. MRI safety in DBS patients is therefore an important consideration. We report our experience with MRI in patients with implanted DBS hardware and examine the literature for clinical reports on MRI safety with implanted DBS hardware. A total of 262 MRI examinations were performed in 223 patients with intracranial DBS hardware, including 45 in patients with an implanted pulse generator. Only 1 temporary adverse event occurred related to patient agitation and movement during immediate postoperative MR imaging. Agitation resolved after a few hours, and an MRI obtained before implanted pulse generator implantation revealed edema around both electrodes. Over 4000 MRI examinations in patients with implanted DBS hardware have been reported in the literature. Only 4 led to adverse events, including 2 hardware failures, 1 temporary and 1 permanent neurological deficit. Adverse neurological events occurred in a unique set of circumstances where appropriate safety protocols were not followed. MRI guidelines provided by DBS hardware manufacturers are inconsistent and vary among devices. The importance of MRI in modern medicine places pressure on industry to develop fully MRI-compatible DBS devices. Until then, the literature suggests that, when observing certain precautions, cranial MR images can be obtained with an extremely low risk in patients with implanted DBS hardware. Copyright © 2011 Elsevier Inc. All rights reserved.

  1. Computational modeling of chemotactic signaling and aggregation of microglia around implantation site during deep brain stimulation

    NASA Astrophysics Data System (ADS)

    Silchenko, A. N.; Tass, P. A.

    2013-10-01

    It is well established that prolonged electrical stimulation of brain tissue causes massive release of ATP in the extracellular space. The released ATP and the products of its hydrolysis, such as ADP and adenosine, become the main elements mediating chemotactic sensitivity and motility of microglial cells via subsequent activation of P2Y2,12 as well as A3A and A2A adenosine receptors. The size of the sheath around the electrode formed by the microglial cells is an important criterion for the optimization of the parameters of electrical current delivered to brain tissue. Here, we study a purinergic signaling pathway underlying the chemotactic motion of microglia towards the implanted electrode during deep brain stimulation. We present a computational model describing formation of a stable aggregate around the implantation site due to the joint chemo-attractive action of ATP and ADP together with a mixed influence of extracellular adenosine. The model was built in accordance with the classical Keller-Segel approach and includes an equation for the cells' density as well as equations describing the hydrolysis of extracellular ATP via successive reaction steps ATP →ADP →AMP →adenosine. The results of our modeling allowed us to reveal the dependence of the width of the encapsulating layer around the electrode on the amount of ATP released due to permanent electrical stimulation. The dependences of the aggregates' size on the parameter governing the nonlinearity of interaction between extracellular adenosine and adenosine receptors are also analyzed.

  2. Adding simultaneous stimulating channels to reduce power consumption in cochlear implants.

    PubMed

    Langner, Florian; Saoji, Aniket A; Büchner, Andreas; Nogueira, Waldo

    2017-03-01

    Sound coding strategies for Cochlear Implant (CI) listeners can be used to control the trade-off between speech performance and power consumption. Most commercial CI strategies use non-simultaneous channel stimulation, stimulating only one electrode at a time. One could add parallel simultaneous stimulating channels such that the electrical interaction between channels is increased. This would produce spectral smearing, because the electrical fields of the simultaneous stimulated channels interact, but also power savings. The parallel channels produce a louder sensation than sequential stimulation. To test this hypothesis we implemented different sound coding strategies using a research interface from Advanced Bionics: the commercial F120 strategy using sequential channel stimulation (one channel equals two electrodes with current steering) and the Paired strategy, consisting of simultaneous stimulation with two channels. Here, the electrical field of both channels will interact, requiring less current on each channel to perceive the same loudness as with F120. However, channel interaction between the independent channels may reduce speech recognition or understanding. This can be diminished by adding an inverse-polarity stimulation channel between both channels. This strategy is termed Paired with Flanks. Additionally, Triplet with three channels and an adjacent Flank style was investigated. For each strategy we measured speech intelligibility with the Hochmair-Schulz-Moser sentence test. Spectral resolution was assessed using a spectral modulation depth detection task. Results show that Paired without Flanks obtains similar performance while reducing the current by 20% on average compared to F120. Triplet with and without Flanks shows overall poorer performance when compared to F120. All strategies inhibit the option to increase the pulse width which would result in even further decreased power consumption.

  3. Stimulation of Osteogenesis in Bone Defects Implanted with Biodegradable Hydroxyapatite Composed of Rod-Shaped Particles under Mechanical Unloading

    PubMed Central

    Ikeda, Tohru; Gonda, Yoshinori; Tatsukawa, Eri; Shibata, Yasuaki; Kamitakahara, Masanobu; Okuda, Takatoshi; Yonezawa, Ikuho; Kurosawa, Hisashi; Ioku, Koji

    2012-01-01

    The aim of this study was to evaluate the influence of mechanical unloading on the repair of bone defects with implantation of biodegradable bone substitutes. Spherical granules of biodegradable hydroxyapatite composed of rod-shaped particles (RHA) or beta-tricalcium phosphate composed of rod-shaped particles (RTCP) were implanted into a bone defect created in the distal end of the right femur of 8-week-old Wistar rats. Two, 6, 10, and 22 weeks after implantation, part of the sciatic nerve in the thigh was resected and exposed to mechanical unloading for 2 weeks. Then, 4, 8, 12 and 24 weeks after implantation, repair of the bone defect was analyzed. As a control, the bone defect without implantation of ceramic granules was also analyzed. Both RHA and RTCP tended to be reduced, but the reduction was not obvious during the experimental period. At 12 and 24 weeks after implantation, the amount of newly formed bone in the animal implanted with RHA was significantly greater than that at 4 weeks after implantation, but that in the animal implanted with RTCP or without implantation was not significantly different. The number of osteoclasts in the region implanted with RHA was significantly larger than that of the region implanted with RTCP or without implantation at 12 and 24 weeks. The activities of alkaline phosphatase in osteoblasts and tartrate-resistant acid phosphatase in osteoclasts were remarkably increased in the bone defects with implantation compared with those in the bone defects without implantation. These results suggested that RHA stimulated osteogenesis and osteoclastogenesis even after 2 weeks of mechanical unloading, and that RHA could be expected to improve the repair of bone defects in patients under the condition of skeletal unloading. PMID:23209337

  4. FREQUENCY-PLACE MAP FOR ELECTRICAL STIMULATION IN COCHLEAR IMPLANTS: CHANGE OVER TIME

    PubMed Central

    Vermeire, Katrien; Landsberger, David M.; Van de Heyning, Paul H.; Voormolen, Maurits; Punte, Andrea Kleine; Schatzer, Reinhold; Zierhofer, Clemens

    2015-01-01

    The relationship between the place of electrical stimulation from a cochlear implant and the corresponding perceived pitch remains uncertain. Previous studies have estimated what the pitch corresponding to a particular location should be. However, perceptual verification is difficult because a subject needs both a cochlear implant and sufficient residual hearing to reliably compare electric and acoustic pitches. Additional complications can arise from the possibility that the pitch corresponding to an electrode may change as the auditory system adapts to a sound processor. In the following experiment, five subjects with normal or near-to-normal hearing in one ear and a cochlear implant with a long electrode array in the other ear were studied. Pitch matches were made between single electrode pulse trains and acoustic tones before activation of the speech processor to gain an estimate of the pitch provided by electrical stimulation at a given insertion angle without the influence of exposure to a sound processor. The pitch matches were repeated after 1, 3, 6, and 12 months of experience with the sound processor to evaluate the effect of adaptation over time. Pre-activation pitch matches were lower than would be estimated by a spiral ganglion pitch map. Deviations were largest for stimulation below 240° degrees and smallest above 480°. With experience, pitch matches shifted towards the frequency-to-electrode allocation. However, no statistically significant pitch shifts were observed over time. The likely explanation for the lack of pitch change is that the frequency-to-electrode allocations for the long electrode arrays were already similar to the pre-activation pitch matches. Minimal place pitch shifts over time suggest a minimal amount of perceptual remapping needed for the integration of electric and acoustic stimuli, which may contribute to shorter times to asymptotic performance. PMID:25840373

  5. Development of a Wireless High-Frequency Microarray Implant for Retinal Stimulation

    NASA Astrophysics Data System (ADS)

    Auner, G. W.; You, R.; Siy, P.; McAllister, J. P.; Talukder, M.; Abrams, G. W.

    We have developed an electrical stimulator and diagnostic research microarray with wireless power and communications to facilitate spatial stimulation of retinal tissue. A third generation 32× 32 prototype of this retinal neural implant array has been developed. Integrated into the microarray is a functionally graded Ti/IrO2 microbump electrode system for interface with neural tissue with decreased impedance for stimulation. The microarray is designed for basic research to determine retinal tissue stimulation thresholds and spatial effects. The array is connected to a telemetry chip, which uses magnetic induction for wireless power with a digital overlay for communication. In our design, changes in the induced current in the telemetry coil are used to send information to the reading coil. Since the reading and telemetry coil are magnetically coupled, the current change can be sensed for bidirectional communication. Combined, this chip set provides a 1024 array that can stimulate neural tissue spatially, can sense neural signals spatially, and has wireless power and communication in a package of less than 2 mm size.

  6. Vagus nerve stimulation: Surgical technique of implantation and revision and related morbidity.

    PubMed

    Giordano, Flavio; Zicca, Anna; Barba, Carmen; Guerrini, Renzo; Genitori, Lorenzo

    2017-04-01

    Indications for vagus nerve stimulation (VNS) therapy include focal, multifocal epilepsy, drop attacks (tonic/atonic seizures), Lennox-Gastaut syndrome, tuberous sclerosis complex (TSC)-related multifocal epilepsy, and unsuccessful resective surgery. Surgical outcome is about 50-60% for seizures control, and may also improve mood, cognition, and memory. On this basis, VNS has also been proposed for the treatment of major depression and Alzheimer's' disease. The vagus nerve stimulator must be implanted with blunt technique on the left side to avoid cardiac side effects through the classic approach for anterior cervical discectomy. The actual device is composed of a wire with three helical contacts (two active contacts, one anchoring) and a one-pin battery. VNS is usually started 2 weeks after implantation with recommended settings of stimulation (1.0-2.0 mA; 500 μs pulse width; 20-30 Hz; 30 s ON, 5 min OFF). The complications of VNS therapy are early (related to surgery) and late (related to the device and to stimulation of the vagus nerve). Early complications include the following: intraoperative bradycardia and asystole during lead impedance testing, peritracheal hematoma, infections (3-8%), and vagus nerve injury followed by hoarseness, dyspnea, and dysphagia because of left vocal cord paralysis. Delayed morbidity due to the device includes late infections or problems in wound healing; other more rare events are due to late injury of the nerve. Late complications due to nerve stimulation include delayed arrhythmias, laryngopharyngeal dysfunction (hoarseness, dyspnea, and coughing), obstructive sleep apnea, stimulation of phrenic nerve, tonsillar pain mimicking glossopharyngeal neuralgia, and vocal cord damage during prolonged endotracheal intubation. The laryngopharyngeal dysfunction occurs in about 66% of patients and is usually transitory and due to the stimulation of the inferior (recurrent) laryngeal nerve. A true late paralysis of the left vocal cord

  7. An implantable, designed-for-human-use peripheral nerve stimulation and recording system for advanced prosthetics.

    PubMed

    Lachapelle, John R; Bjune, Caroline K; Kindle, Alexander L; Czarnecki, Andrew; Burns, John R; Grainger, Julianne E; Segura, Carlos A; Nugent, Brian D; Sriram, Tirunelveli S; Parks, Philip D; Keefer, Edward; Cheng, Jonathan

    2016-08-01

    Complex suture prostheses that deliver sensory and position feedback require a more sophisticated integration with the human user. Here a micro-size active implantable system that provides many-degree-of-freedom neural feedback in both sensory stimulation and motor control is shown, as one potential human-use solution in DARPA's HAPTIX program. Various electrical and mechanical challenge and solutions in meeting both sensory /motor performance as well as ISO 14708 FDA-acceptable human use in an aspirin-size active implementation are discussed.

  8. Divergent endometrial inflammatory cytokine expression at peri-implantation period and after the stimulation by copper intrauterine device.

    PubMed

    Chou, Chia-Hung; Chen, Shee-Uan; Shun, Chia-Tung; Tsao, Po-Nien; Yang, Yu-Shih; Yang, Jehn-Hsiahn

    2015-10-15

    Endometrial inflammation has contradictory effects. The one occurring at peri-implantation period is favourable for embryo implantation, whereas the other occurring after the stimulation by copper intrauterine device (Cu-IUD) prevents from embryo implantation. In this study, 8 week female ICR mice were used to investigate the endometrial inflammation, in which they were at proestrus stage (Group 1), at peri-implantation period (Group 2), and had a copper wire implanted into right uterine horn (Group 3). Cytokine array revealed that two cytokines were highly expressed in Group 2 and Group 3 as compared with Group 1, and seven cytokines, including tumour necrosis factor α (TNF-α), had selectively strong expression in Group 3. Immunohistochemistry demonstrated prominent TNF-α staining on the endometrium after Cu-IUD stimulation, and in vitro culture of human endometrial glandular cells with Cu induced TNF-α secretion. The increased TNF-α concentration enhanced in vitro THP-1 cells chemotaxis, and reduced embryo implantation rates. These results suggest that inflammatory cytokine profiles of endometrium are different between those at peri-implantation period and after Cu-IUD stimulation, and TNF-α is the one with selectively strong expression in the latter. It might account for the contradictory biological effects of endometrial inflammation.

  9. Divergent endometrial inflammatory cytokine expression at peri-implantation period and after the stimulation by copper intrauterine device

    PubMed Central

    Chou, Chia-Hung; Chen, Shee-Uan; Shun, Chia-Tung; Tsao, Po-Nien; Yang, Yu-Shih; Yang, Jehn-Hsiahn

    2015-01-01

    Endometrial inflammation has contradictory effects. The one occurring at peri-implantation period is favourable for embryo implantation, whereas the other occurring after the stimulation by copper intrauterine device (Cu-IUD) prevents from embryo implantation. In this study, 8 week female ICR mice were used to investigate the endometrial inflammation, in which they were at proestrus stage (Group 1), at peri-implantation period (Group 2), and had a copper wire implanted into right uterine horn (Group 3). Cytokine array revealed that two cytokines were highly expressed in Group 2 and Group 3 as compared with Group 1, and seven cytokines, including tumour necrosis factor α (TNF-α), had selectively strong expression in Group 3. Immunohistochemistry demonstrated prominent TNF-α staining on the endometrium after Cu-IUD stimulation, and in vitro culture of human endometrial glandular cells with Cu induced TNF-α secretion. The increased TNF-α concentration enhanced in vitro THP-1 cells chemotaxis, and reduced embryo implantation rates. These results suggest that inflammatory cytokine profiles of endometrium are different between those at peri-implantation period and after Cu-IUD stimulation, and TNF-α is the one with selectively strong expression in the latter. It might account for the contradictory biological effects of endometrial inflammation. PMID:26469146

  10. Hormonal action of relaxin-like gonad-stimulating substance (GSS) on starfish ovaries in growing and fully grown states.

    PubMed

    Mita, Masatoshi; Yamamoto, Kazutoshi; Nakamura, Masaru; Nagahama, Yoshitaka

    2011-05-15

    Gonad-stimulating substance (GSS) of starfish is the only known invertebrate peptide hormone responsible for final gamete maturation, rendering it functionally analogous to gonadotropins in vertebrates. Recently, we purified GSS from the radial nerves of the starfish Asterina pectinifera and identified the chemical structure as a relaxin-like peptide. This study examined the hormonal action of GSS on ovaries in the growing (stage IV) and fully grown states (stage V) of the starfish. The sensitivity of oocytes to 1-methyladenine (1-MeAde) as starfish maturation-inducing hormone was enhanced as oocytes enlarged in stage V. GSS-stimulated 1-MeAde production by ovarian follicle cells was also correlated with the size of oocytes. Although 1-MeAde production was observed in whole ovaries in stage V, GSS failed to induce 1-MeAde production in young ovaries (stage IV). This suggests that follicle cells in ovaries in a growing state (stage IV) are still unresponsive to the hormonal action of GSS. According to competitive experiments using radioiodinated and radioinert GSS, however, dissociation constant (K(d)) values and the number of binding sites for GSS were mostly constant in the ovaries from stages IV to V. These results strongly suggest that GSS receptors are expressed in follicle cells of ovaries in the growing state. The failure of GSS to induce 1-MeAde production in young ovaries may be due to the uncoupling of signal transduction from the receptor to 1-MeAde biosynthesis in follicle cells. Copyright © 2011 Elsevier Inc. All rights reserved.

  11. Design of a semi-implantable hearing device for direct acoustic cochlear stimulation.

    PubMed

    Bernhard, Hans; Stieger, Christof; Perriard, Yves

    2011-02-01

    A new hearing therapy based on direct acoustic cochlear stimulation was developed for the treatment of severe to profound mixed hearing loss. The device efficacy was validated in an initial clinical trial with four patients. This semi-implantable investigational device consists of an externally worn audio processor, a percutaneous connector, and an implantable microactuator. The actuator is placed in the mastoid bone, right behind the external auditory canal. It generates vibrations that are directly coupled to the inner ear fluids and that, therefore, bypass the external and the middle ear. The system is able to provide an equivalent sound pressure level of 125 dB over the frequency range between 125 and 8000 Hz. The hermetically sealed actuator is designed to provide maximal output power by keeping its dimensions small enough to enable implantation. A network model is used to simulate the dynamic characteristics of the actuator to adjust its transfer function to the characteristics of the middle ear. The geometry of the different actuator components is optimized using finite-element modeling.

  12. Signal coding in cochlear implants: exploiting stochastic effects of electrical stimulation.

    PubMed

    Rubinstein, Jay T; Hong, Robert

    2003-09-01

    Speech perception in quiet with cochlear implants has increased substantially over the past 17 years. If current trends continue, average monosyllabic word scores will be nearly 80% by 2010. These improvements are due to enhancements in speech processing strategies, to the implantation of patients with more residual hearing and shorter durations of deafness, and to unknown causes. Despite these improvements, speech perception in noise and music perception are still poor in most implant patients. These deficits may be partly due to poor representation of temporal fine structure by current speech processing strategies. It may be possible to improve both this representation and the dynamic range of electrical stimulation through the exploitation of stochastic effects produced by high-rate (eg, 5-kilopulse-per-second) pulse trains. Both the loudness growth and the dynamic range of low-frequency sinusoids have been enhanced via this technique. A laboratory speech processor using this strategy is under development. Although the clinical programming for such an algorithm is likely to be complex, some guidelines for the psychophysical and electrophysiological techniques necessary can be described now.

  13. The parturient with implanted spinal cord stimulator: management and review of the literature.

    PubMed

    Young, Adam C; Lubenow, Timothy R; Buvanendran, Asokumar

    2015-01-01

    Spinal cord stimulation (SCS) is an approved treatment for complex regional pain syndrome and other chronic pain conditions. These devices enable women with chronic pain to maintain relatively normal lives, with some encountering pregnancy. Use of previously implanted SCS systems in pregnant women is considered controversial due to lack of long-term prospective studies evaluating both maternal and fetal safety. Seven patients at a university pain clinic were identified as having SCS implanted before becoming pregnant. Data on these patients before, during, and after labor were collected through chart review and patient interview. Onset of labor varied among the 7 patients (2 preterm and 5 term). Mode of anesthesia for delivery included 4 neuraxial anesthetics, with 3 successfully obtaining an adequate level of anesthesia for delivery. Four general anesthetics were administered for cesarean delivery, one of which included a failed attempt at neuraxial anesthesia. All infants were born healthy. Management approaches and outcomes in our patients, as well as those previously reported are discussed within this article. Definitive conclusions cannot be drawn from this small cohort. We believe that management of a parturient with an implanted SCS requires careful planning between all peripartum physicians.

  14. A zero-voltage switching technique for minimizing the current-source power of implanted stimulators.

    PubMed

    Çilingiroğlu, Uğur; İpek, Sercan

    2013-08-01

    The current-source power of an implanted stimulator is reduced almost to the theoretical minimum by driving the electrodes directly from the secondary port of the inductive link with a dedicated zero-voltage switching power supply. A feedback loop confined to the secondary of the inductive link adjusts the timing and conduction angle of switching to provide just the right amount of supply voltage needed for keeping the current-source voltage constant at or slightly above the compliance limit. Since drive is based on current rather than voltage, and supply-voltage update is near real-time, the quality of the current pulses is high regardless of how the electrode impedance evolves during stimulation. By scaling the switching frequency according to power demand, the technique further improves overall power consumption of the stimulator. The technique is implemented with a very simple control circuitry comprising a comparator, a Schmitt trigger and a logic gate of seven devices in addition to an on-chip switch and an off-chip capacitor. The power consumed by the proposed supply circuit itself is no larger than what the linear regulator of a conventional supply typically consumes for the same stimulation current. Still, the sum of supply and current-source power is typically between 20% and 75% of the conventional source power alone. Functionality of the proposed driver is verified experimentally on a proof-of-concept prototype built with 3.3 V devices in a 0.18 μm CMOS technology.

  15. A wirelessly controlled implantable LED system for deep brain optogenetic stimulation

    PubMed Central

    Rossi, Mark A.; Go, Vinson; Murphy, Tracy; Fu, Quanhai; Morizio, James; Yin, Henry H.

    2015-01-01

    In recent years optogenetics has rapidly become an essential technique in neuroscience. Its temporal and spatial specificity, combined with efficacy in manipulating neuronal activity, are especially useful in studying the behavior of awake behaving animals. Conventional optogenetics, however, requires the use of lasers and optic fibers, which can place considerable restrictions on behavior. Here we combined a wirelessly controlled interface and small implantable light-emitting diode (LED) that allows flexible and precise placement of light source to illuminate any brain area. We tested this wireless LED system in vivo, in transgenic mice expressing channelrhodopsin-2 in striatonigral neurons expressing D1-like dopamine receptors. In all mice tested, we were able to elicit movements reliably. The frequency of twitches induced by high power stimulation is proportional to the frequency of stimulation. At lower power, contraversive turning was observed. Moreover, the implanted LED remains effective over 50 days after surgery, demonstrating the long-term stability of the light source. Our results show that the wireless LED system can be used to manipulate neural activity chronically in behaving mice without impeding natural movements. PMID:25713516

  16. Ultrasound-guided permanent implantation of peripheral nerve stimulation (PNS) system for neuropathic pain of the extremities: original cases and outcomes.

    PubMed

    Huntoon, Marc A; Burgher, Abram H

    2009-11-01

    Our objective is to describe our experience applying a minimally invasive, ultrasound-assisted technique for peripheral nerve stimulation (PNS) trial and permanent implantation in patients with neuropathic extremity pain. Retrospective case series and review of the literature. Setting. Tertiary referral center and academic medical center. Patients with upper or lower extremity neuropathic pain resistant to other therapies who responded to an ultrasound-guided peripheral nerve block at a proximal location. Interventions. Ultrasound-assisted through-the-needle placement of percutaneous neurostimulation electrodes on target major peripheral nerves for fully percutaneous trial, staged trial or permanent implantation of PNS system. A PNS trial period of 3-7 days was used. Pain relief at last follow-up, complications, therapeutic limitations due to technique as applied. Results. Six of eight (75%) patients and 7/9 (78%) peripheral nerves had a successful trial and underwent permanent PNS system implantation using a minimally invasive, ultrasound-assisted technique from November 2007 to December 2008. All but one patient with an implanted PNS system had > or =50% pain relief at last follow-up and 3/7 (43%) permanent systems were associated with > or =80% relief. Loss of paresthesia required revision to dual-lead systems in upper extremity radial nerve PNS. Infection led to explant in one case. In a small series of patients, a minimally invasive, ultrasound-assisted technique for PNS trial, and permanent PNS implantation proved feasible. Patients without adequate analgesia during neurostimulation trial avoided surgical incision and those undergoing permanent implantation were not subjected to the potential morbidity associated with nerve dissection.

  17. Anesthesia considerations for patients with an implanted deep brain stimulator undergoing surgery: a review and update.

    PubMed

    Yeoh, Tze Yeng; Manninen, Pirjo; Kalia, Suneil K; Venkatraghavan, Lashmi

    2017-03-01

    Deep brain stimulation (DBS) can be an effective treatment option for patients with essential tremor and Parkinson's disease. This review provides an overview on the functioning of neurostimulators and recent advances in this technology and presents an updated guide on the anesthetic management of patients with an implanted neurostimulator undergoing surgery or medical intervention. A search was conducted on MEDLINE®, EMBASE™, and Cochrane Database of Systematic Reviews databases to identify studies published in English from 1974 to December 2015. Our search also included relevant and available incident reports from the manufacturers, Health Canada, the United States Food and Drug Administration, and the European Medicines Agency. Thirty of 232 articles identified were found to be relevant to this review. Deep brain stimulation systems now offer a range of options, including pulse generators with dual-channel capabilities, rechargeable batteries, and current-control modes. Preoperatively, the anesthesiologist should ascertain the indications for DBS therapy, identify the type of device implanted, and consult a DBS specialist for specific precautions and device management. The major perioperative concern is the potential for interactions with the medical device resulting in patient morbidity. Neurostimulators should be turned off intraoperatively to minimize electromagnetic interference, and precautions should be taken when using electrosurgical equipment. Following surgery, the device should be turned on and checked by a DBS specialist. The anesthesiologist plays an important role to ensure a safe operating environment for patients with an implanted DBS device. Pertinent issues include identifying the type of device, involving a DBS-trained physician, turning off the device intraoperatively, implementing precautions when using electrosurgical equipment, and checking the device postoperatively.

  18. Successful implantation of a deep brain stimulator for essential tremor in a patient with a preexisting cochlear implant: surgical technique: technical case report.

    PubMed

    De Los Reyes, Kenneth; Chandrasekhar, Sujana S; Tagliati, Michele; Alterman, Ron

    2010-06-01

    Deep brain stimulation (DBS) has become routine for the treatment of Parkinson's disease and essential tremor. Because both of these disorders are common in patients older than the age of 60, neurosurgeons are likely to encounter increasing numbers of patients who require DBS surgery but who already have another electronic medical implant such as a cardiac pacemaker/defibrillator or intrathecal infusion pump, raising the concern that one device might interfere with the performance of the other. Herein we report a modification of surgical technique resulting in the successful use of thalamic DBS to treat disabling essential tremor in a man with a previously implanted cochlear implant. The presence of the cochlear implant necessitated a number of modifications to our standard surgical technique including surgical removal of the subgaleal magnet that holds the receiver to the scalp and the use of computed tomography instead of magnetic resonance imaging to target the thalamus. More than a year after surgery, the patient is enjoying continued tremor suppression and an enhanced quality of life. The presence of the DBS device has not interfered with the proper functioning of his cochlear implant. DBS can be used successfully in patients with a previously implanted cochlear implant. The operating neurosurgeon should be aware of the limitations of intraoperative imaging and the need to coordinate with an otologic surgeon for maximum patient benefit.

  19. A novel implantation technique for pudendal nerve stimulation for treatment of overactive bladder and urgency incontinence.

    PubMed

    Possover, Marc

    2014-01-01

    Herein is described laparoscopic implantation of a neuroprosthesis to the pudendal nerve for treatment of non-neurogenic bladder overactivity. This case series study was performed at a tertiary referral unit that specializes in advanced gynecologic surgery and neuropelveology. Fourteen consecutive male and female patients underwent laparoscopic implantation of an electrode to the endopelvic portion of the pudendal nerve for pudendal neuromodulation. All procedures were performed successfully via laparoscopy, without any complications. The mean operative time for the entire procedure was 18 minutes. After a successful test phase of external stimulation, 11 patients (78.57%) underwent implantation of a permanent generator. These patients demonstrated a mean (SD) decreased micturition frequency, from 25 (11.7; range, 13-50) per day on average to 10.18 (2.7; range, 7-15) at final evaluation (mean follow-up, 18 months; range 9-49 months). Nocturia decreased from 5.82 (4.2; range, 3-18) to 2.18 (1.08; range, 1-5) micturitions per night. Cystometric bladder capacities increased from 159 mL (53; range, 80-230 mL) to 312 mL (104.9;160-500 mL). Mean incontinence episodes at the initial evaluation, based on a 3-day voiding diary, were 8.1. At final evaluation, 6 patients were completely dry. Number of pads used per day decreased from 7.3 (4.2) to 1.6 (2.3). No lead dislocation or migration occurred. It was concluded that laparoscopic implantation of a neuroprosthesis to the pudendal nerve is an effective, safe, and reproducible day procedure for treatment of intractable non-neurogenic overactive bladder with urinary urgency incontinence. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.

  20. Epidural hematomas after the implantation of thoracic paddle spinal cord stimulators.

    PubMed

    Moufarrij, Nazih A

    2016-10-01

    OBJECTIVE There is little information on the frequency of symptomatic epidural hematomas after the implantation of paddle spinal cord stimulators (SCSs) in the thoracic spine. The purpose of this paper is to provide this metric and compare it to the frequency of symptomatic epidural hematomas for all other thoracic laminectomies combined. METHODS This study involved retrospectively analyzing the experience of a single surgeon in a consecutive series of patients who underwent the implantation of a thoracic paddle SCS with respect to the occurrence of a symptomatic epidural hematoma. For comparison, the occurrence of a symptomatic epidural hematoma in non-SCS thoracic laminectomies done during the same period of time was determined. RESULTS One hundred fifty-four thoracic paddle SCSs were implanted between May 2002 and February 2015. Despite perfect hemostasis and no preoperative risk factors, 4 of 154 patients (2.60%) developed postoperative lower-extremity weakness caused by an epidural hematoma. There were no other causes of a neurological deficit. In 3 of the 4 patients, the symptoms were delayed. Over the same time period, only 1 of 119 patients (0.84%) developed a postoperative motor deficit from a symptomatic epidural hematoma after a non-SCS laminectomy. CONCLUSIONS The occurrence of epidural hematomas after thoracic paddle SCS implantation may be underreported. Suggestions are given to decrease its incidence. It seems paradoxical that an epidural hematoma occurred 3 times more often after small SCS thoracic laminectomies than after larger non-SCS thoracic laminectomies. If confirmed by future studies, this finding may suggest that the intrusion of instruments into a confined epidural sublaminar space or the presence of a paddle and a hematoma in this restricted space may account for this differential.

  1. Cytokine Profiling in the Eutopic Endometrium of Adenomyosis During the Implantation Window After Ovarian Stimulation.

    PubMed

    Zhihong, N; Yun, F; Pinggui, Z; Sulian, Z; Zhang, Aijun

    2016-01-01

    In this study, we aimed to clarify the inflammatory cytokine profile of endometrium in patients with adenomyosis during the implantation window after ovarian stimulation. Eighteen patients with adenomyosis and 24 control patients undergoing in vitro fertilization treatment were included in this prospective case-control study. Regular gonadotropin-releasing hormone antagonist protocol was used for ovarian stimulation. Endometrial samples were obtained 7 days after human chorionic gonadotropin (hCG) injection (hCG + 7). Cytokine levels in endometrium secretions from women with and without adenomyosis were assayed by multiplex immunoassay, levels of interleukin (IL) 6 (25.9 ± 6.6 vs 12.4 ± 3.4 pg/mL; P = .001), IL-10 (10.4 ± 2.9 vs 15.6 ± 4.2 pg/mL; P = .001), IL-17 (11.9 ± 3.0 vs 14.2 ± 3.9 pg/mL; P = .046), interferon-γ (11.7 ± 3.5 vs 8.0 ± 3.4 pg/mL; P = .001), and monocyte chemoattractant protein-1 (MCP-1; 37.1 ± 6.5 vs 16.4 ± 3.2 pg/mL; P = .001) were significantly different between patients with adenomyosis and control groups, respectively. Immunohistochemistry and quantitative real-time polymerase chain reaction showed that CD-68+, IL-6, and MCP-1 expression were higher and IL-10 was lower in adenomyosis endometrium epithelia compared to controls. In conclusion, within the implantation window of ovarian stimulation cycles, macrophages, IL-6, IL-10, and MCP-1 are expressed differently in the endometrium of women with adenomyosis, which may correlate with compromised endometrium receptivity. We postulated that cytokines of endometrial secretions expressed differently in patients with adenomyosis may contribute to impaired endometrium receptivity in these patients.

  2. Bio-Impedance Characterization Technique with Implantable Neural Stimulator Using Biphasic Current Stimulus

    PubMed Central

    Lo, Yi-Kai; Chang, Chih-Wei; Liu, Wentai

    2016-01-01

    Knowledge of the bio-impedance and its equivalent circuit model at the electrode-electrolyte/tissue interface is important in the application of functional electrical stimulation. Impedance can be used as a merit to evaluate the proximity between electrodes and targeted tissues. Understanding the equivalent circuit parameters of the electrode can further be leveraged to set a safe boundary for stimulus parameters in order not to exceed the water window of electrodes. In this paper, we present an impedance characterization technique and implement a proof-of-concept system using an implantable neural stimulator and an off-the-shelf microcontroller. The proposed technique yields the parameters of the equivalent circuit of an electrode through large signal analysis by injecting a single low-intensity biphasic current stimulus with deliberately inserted inter-pulse delay and by acquiring the transient electrode voltage at three well-specified timings. Using low-intensity stimulus allows the derivation of electrode double layer capacitance since capacitive charge-injection dominates when electrode overpotential is small. Insertion of the inter-pulse delay creates a controlled discharge time to estimate the Faradic resistance. The proposed method has been validated by measuring the impedance of a) an emulated Randles cells made of discrete circuit components and b) a custom-made platinum electrode array in-vitro, and comparing estimated parameters with the results derived from an impedance analyzer. The proposed technique can be integrated into implantable or commercial neural stimulator system at low extra power consumption, low extra-hardware cost, and light computation. PMID:25569999

  3. Bio-impedance characterization technique with implantable neural stimulator using biphasic current stimulus.

    PubMed

    Lo, Yi-Kai; Chang, Chih-Wei; Liu, Wentai

    2014-01-01

    Knowledge of the bio-impedance and its equivalent circuit model at the electrode-electrolyte/tissue interface is important in the application of functional electrical stimulation. Impedance can be used as a merit to evaluate the proximity between electrodes and targeted tissues. Understanding the equivalent circuit parameters of the electrode can further be leveraged to set a safe boundary for stimulus parameters in order not to exceed the water window of electrodes. In this paper, we present an impedance characterization technique and implement a proof-of-concept system using an implantable neural stimulator and an off-the-shelf microcontroller. The proposed technique yields the parameters of the equivalent circuit of an electrode through large signal analysis by injecting a single low-intensity biphasic current stimulus with deliberately inserted inter-pulse delay and by acquiring the transient electrode voltage at three well-specified timings. Using low-intensity stimulus allows the derivation of electrode double layer capacitance since capacitive charge-injection dominates when electrode overpotential is small. Insertion of the inter-pulse delay creates a controlled discharge time to estimate the Faradic resistance. The proposed method has been validated by measuring the impedance of a) an emulated Randles cells made of discrete circuit components and b) a custom-made platinum electrode array in-vitro, and comparing estimated parameters with the results derived from an impedance analyzer. The proposed technique can be integrated into implantable or commercial neural stimulator system at low extra power consumption, low extra-hardware cost, and light computation.

  4. Brachial insertion of fully implantable venous catheters for chemotherapy: complications and quality of life assessment in 35 patients

    PubMed Central

    Fonseca, Igor Yoshio Imagawa; Krutman, Mariana; Nishinari, Kenji; Yazbek, Guilherme; Teivelis, Marcelo Passos; Bomfim, Guilherme André Zottele; Cavalcante, Rafael Noronha; Wolosker, Nelson

    2016-01-01

    ABSTRACT Objective To prospectively evaluate the perioperative safety, early complications and satisfaction of patients who underwent the implantation of central catheters peripherally inserted via basilic vein. Methods Thirty-five consecutive patients with active oncologic disease requiring chemotherapy were prospectively followed up after undergoing peripheral implantation of indwelling venous catheters, between November 2013 and June 2014. The procedures were performed in the operating room by the same team of three vascular surgeons. The primary endpoints assessed were early postoperative complications, occurring within 30 days after implantation. The evaluation of patient satisfaction was based on a specific questionnaire used in previous studies. Results In all cases, ultrasound-guided puncture of the basilic vein was feasible and the procedure successfully completed. Early complications included one case of basilic vein thrombophlebitis and one case of pocket infection that did not require device removal. Out of 35 patients interviewed, 33 (94.3%) would recommend the device to other patients. Conclusion Implanting brachial ports is a feasible option, with low intraoperative risk and similar rates of early postoperative complications when compared to the existing data of the conventional technique. The patients studied were satisfied with the device and would recommend the procedure to others. PMID:28076593

  5. First permanent implant of nerve stimulation leads activated by surface electrodes, enabling hand grasp and release: the stimulus router neuroprosthesis.

    PubMed

    Gan, Liu Shi; Ravid, Einat; Kowalczewski, Jan Andrzej; Olson, Jaret Lawrence; Morhart, Michael; Prochazka, Arthur

    2012-05-01

    . More than 150 000 neuroprostheses (NPs) have been implanted in people to restore bodily function in a variety of neural disorders. The authors developed a novel NP, the Stimulus Router System (SRS), in which only passive leads are implanted. Each lead picks up a portion of the current delivered through the skin by an external stimulator. . The authors report on the first human implant of an SRS. . The recipient was a tetraplegic man with bilateral hand paralysis. Three SRS leads were implanted in his right forearm to activate the finger extensors, finger flexors, and thumb flexor. A wristlet containing a surface stimulator and electrodes was used to pass trains of electrical pulses through the skin to each lead. Hand opening and grasp were controlled via a wireless earpiece that sensed small tooth-clicks and transmitted signals to the wristlet. . The current required to activate the muscles was less than half that required prior to implantation and below perceptual threshold. Maximal grip force and hand opening aperture were both larger using the SRS. The implanted leads have remained functional for 3 years. The recipient reported various tasks of daily life that improved during SRS usage. An electronic counter revealed mean monthly usage of 18.5 hours, equivalent to 55 hours of continuous manual activity. . This first implant of the SRS indicates that it can be effective and reliable and has potential to provide an alternative to existing NPs.

  6. Representations of Time-Varying Cochlear Implant Stimulation in Auditory Cortex of Awake Marmosets (Callithrix jacchus).

    PubMed

    Johnson, Luke A; Della Santina, Charles C; Wang, Xiaoqin

    2017-07-19

    Electrical stimulation of the auditory periphery organ by cochlear implant (CI) generates highly synchronized inputs to the auditory system. It has long been thought such inputs would lead to highly synchronized neural firing along the ascending auditory pathway. However, neurophysiological studies with hearing animals have shown that the central auditory system progressively converts temporal representations of time-varying sounds to firing rate-based representations. It is not clear whether this coding principle also applies to highly synchronized CI inputs. Higher-frequency modulations in CI stimulation have been found to evoke largely transient responses with little sustained firing in previous studies of the primary auditory cortex (A1) in anesthetized animals. Here, we show that, in addition to neurons displaying synchronized firing to CI stimuli, a large population of A1 neurons in awake marmosets (Callithrix jacchus) responded to rapid time-varying CI stimulation with discharges that were not synchronized to CI stimuli, yet reflected changing repetition frequency by increased firing rate. Marmosets of both sexes were included in this study. By comparing directly each neuron's responses to time-varying acoustic and CI signals, we found that individual A1 neurons encode both modalities with similar firing patterns (stimulus-synchronized or nonsynchronized). These findings suggest that A1 neurons use the same basic coding schemes to represent time-varying acoustic or CI stimulation and provide new insights into mechanisms underlying how the brain processes natural sounds via a CI device.SIGNIFICANCE STATEMENT In modern cochlear implant (CI) processors, the temporal information in speech or environmental sounds is delivered through modulated electric pulse trains. How the auditory cortex represents temporally modulated CI stimulation across multiple time scales has remained largely unclear. In this study, we compared directly neuronal responses in primary

  7. Characteristics of electrode impedance and stimulation efficacy of a chronic cortical implant using novel annulus electrodes in rat motor cortex.

    PubMed

    Wang, Chun; Brunton, Emma; Haghgooie, Saman; Cassells, Kahli; Lowery, Arthur; Rajan, Ramesh

    2013-08-01

    Cortical neural prostheses with implanted electrode arrays have been used to restore compromised brain functions but concerns remain regarding their long-term stability and functional performance. Here we report changes in electrode impedance and stimulation thresholds for a custom-designed electrode array implanted in rat motor cortex for up to three months. The array comprises four 2000 µm long electrodes with a large annular stimulating surface (7860-15700 µm(2)) displaced from the penetrating insulated tip. Compared to pre-implantation in vitro values there were three phases of impedance change: (1) an immediate large increase of impedance by an average of two-fold on implantation; (2) a period of continued impedance increase, albeit with considerable variability, which reached a peak at approximately four weeks post-implantation and remained high over the next two weeks; (3) finally, a period of 5-6 weeks when impedance stabilized at levels close to those seen immediately post-implantation. Impedance could often be temporarily decreased by applying brief trains of current stimulation, used to evoke motor output. The stimulation threshold to induce observable motor behaviour was generally between 75-100 µA, with charge density varying from 48-128 µC cm(-2), consistent with the lower current density generated by electrodes with larger stimulating surface area. No systematic change in thresholds occurred over time, suggesting that device functionality was not compromised by the factors that caused changes in electrode impedance. The present results provide support for the use of annulus electrodes in future applications in cortical neural prostheses.

  8. Sensitivity to interaural time differences with combined cochlear implant and acoustic stimulation.

    PubMed

    Francart, Tom; Brokx, Jan; Wouters, Jan

    2009-03-01

    The interaural time difference (ITD) is an important cue to localize sound sources. Sensitivity to ITD was measured in eight users of a cochlear implant (CI) in the one ear and a hearing aid (HA) in the other severely impaired ear. The stimulus consisted of an electric pulse train of 100 pps and an acoustic filtered click train. Just-noticeable differences (JNDs) in ITD were measured using a lateralization paradigm. Four subjects exhibited median JNDs in ITD of 156, 341, 254, and 91 mus; the other subjects could not lateralize the stimuli consistently. Only the subjects who could lateralize had average acoustic hearing thresholds at 1,000 and 2,000 Hz better than 100-dB SPL. The electric signal had to be delayed by 1.5 ms to achieve synchronous stimulation at the auditory nerves.

  9. Spinal Cord Stimulation (SCS)—The Implantable Systems Performance Registry (ISPR)

    PubMed Central

    Schultz, David M.; Calodney, Aaron K.; Mogilner, Alon Y.; Weaver, Todd W.; Wells, Michelle D.; Stromberg, E. Katherine; Roediger, Mollie P.; Sasaki, John T.

    2016-01-01

    Objectives The Implantable Systems Performance Registry (ISPR) was created to monitor the product performance of Medtronic Spinal Cord Stimulation (SCS) and implanted intrathecal drug infusion systems available in the United States. Materials and Methods Data were collected on 2605 patients from 44 centers from various geographic regions across the United States implanting and following patients with SCS systems between June 25, 2004 and January 31, 2014. Actuarial life table methods are used to estimate device performance over time. Of the 2605 patients, 1490 (57.2%) were female, 1098 (42.1%) were male and 17 (0.7%) did not provide gender data. The average age at enrollment was 56.3 years (range: 4–97, SD = 14.3) and average follow‐up time was 20.1 months (SD = 22.5). Results Currently the estimates of device survival from neurostimulator‐related events exceed 97% for all neurostimulator models across the applicable follow‐up time points and all applicable extension models had greater than 95% survival from extension events. The majority of product performance events were lead‐related. At 5 years of follow‐up, all applicable lead families, with the exception of the Pisces‐Quad LZ family, had greater than 75% survival from lead events. Conclusions The ISPR is designed to serve as an ongoing source of system and device‐related information with a focus on “real‐world” safety and product performance. ISPR data continue to be used to guide future product development efforts aimed at improving product reliability and quality. PMID:27730706

  10. Permanent implantation of peripheral nerve stimulator for combat injury-related ilioinguinal neuralgia.

    PubMed

    Banh, Diem Phuc T; Moujan, Pablo M; Haque, Quazi; Han, Tae-Hyung

    2013-01-01

    A peripheral nerve stimulator (PNS) can be an alternative for long-term pain relief refractory to conventional therapeutic modalities. We present a case of chronic incapacitating ilioinguinal neuralgia, which was successfully managed with permanent implantation of a peripheral nerve stimulator. A 26-year-old active duty African American man was referred to the University Pain Clinic with left ilioinguinal neuralgia due to shrapnel injury during his military service 6 years prior to his visit. Most of the shrapnel were surgically removed, but the patient subsequently developed left lower abdominal pain. Multiple surgeries, including inguinal herniorrhaphy, varicocelectomy, and orchiectomy, failed to provide satisfactory relief of his neuralgia. Other therapies tried resulting in limited outcomes were multiple ilioinguinal nerve blocks and cryoanalgesia. A trial of PNS was successful and the implantation of permanent leads was carried out. At his 3-month visit, the patient reported to have minimal pain, was tapered off oral analgesics, was able to return to work, and had resumed his normal daily activities. Recent technological advances in programming software and surgical techniques have led to renewed interest in PNS for the treatment of chronic refractory peripheral nerve injury. Despite our limited understanding of its exact mechanism of action, it can be considered as a therapeutic potential for a few carefully selected, intractable cases. Its minimally invasive and reversible features make PNS a favorable option for these patients. The stringent and rigorous screening procedures for suitable candidacy, documentation of previously failed treatments, psychiatric evaluation, and 3-5 days of preplacement trial, improve the success rate.

  11. Cochlear Implant Electrode Effect on Sound Energy Transfer within the Cochlea during Acoustic Stimulation

    PubMed Central

    Greene, Nathaniel T.; Mattingly, Jameson K.; Jenkins, Herman A.; Tollin, Daniel J.; Easter, James R.; Cass, Stephen P.

    2015-01-01

    Hypothesis Cochlear implants (CI) designed for hearing preservation will not alter mechanical properties of the middle and inner ear as measured by intracochlear pressure (PIC) and stapes velocity (Vstap). Background CIs designed to provide combined electrical and acoustic stimulation (EAS) are now available. To maintain functional acoustic hearing, it is important to know if a CI electrode can alter middle or inner ear mechanics, as any alteration could contribute to elevated low-frequency thresholds in EAS patients. Methods Seven human cadaveric temporal bones were prepared, and pure-tone stimuli from 120Hz–10kHz were presented at a range of intensities up to 110 dB SPL. PIC in the scala vestibuli (PSV) and tympani (PST) were measured with fiber-optic pressure sensors concurrently with VStap using laser Doppler vibrometry. Five CI electrodes from two different manufacturers, with varying dimensions were inserted via a round window approach at six different depths (16–25 mm). Results The responses of PIC and VStap to acoustic stimulation were assessed as a function of stimulus frequency, normalized to SPL in the external auditory canal (EAC), in baseline and electrode inserted conditions. Responses measured with electrodes inserted were generally within ~5 dB of baseline, indicating little effect of cochlear implant electrode insertion on PIC and VStap. Overall, mean differences across conditions were small for all responses, and no substantial differences were consistently visible across electrode types. Conclusions Results suggest that the influence of a CI electrode on middle and inner ear mechanics is minimal, despite variation in electrode lengths and configurations. PMID:26333018

  12. Brachial insertion of fully implantable venous catheters for chemotherapy: complications and quality of life assessment in 35 patients.

    PubMed

    Fonseca, Igor Yoshio Imagawa; Krutman, Mariana; Nishinari, Kenji; Yazbek, Guilherme; Teivelis, Marcelo Passos; Bomfim, Guilherme André Zottele; Cavalcante, Rafael Noronha; Wolosker, Nelson

    2016-01-01

    To prospectively evaluate the perioperative safety, early complications and satisfaction of patients who underwent the implantation of central catheters peripherally inserted via basilic vein. Thirty-five consecutive patients with active oncologic disease requiring chemotherapy were prospectively followed up after undergoing peripheral implantation of indwelling venous catheters, between November 2013 and June 2014. The procedures were performed in the operating room by the same team of three vascular surgeons. The primary endpoints assessed were early postoperative complications, occurring within 30 days after implantation. The evaluation of patient satisfaction was based on a specific questionnaire used in previous studies. In all cases, ultrasound-guided puncture of the basilic vein was feasible and the procedure successfully completed. Early complications included one case of basilic vein thrombophlebitis and one case of pocket infection that did not require device removal. Out of 35 patients interviewed, 33 (94.3%) would recommend the device to other patients. Implanting brachial ports is a feasible option, with low intraoperative risk and similar rates of early postoperative complications when compared to the existing data of the conventional technique. The patients studied were satisfied with the device and would recommend the procedure to others. Avaliar prospectivamente segurança perioperatória, complicações precoces e grau de satisfação de pacientes submetidos ao implante de cateteres centrais de inserção periférica pela veia basílica. Foram acompanhados prospectivamente e submetidos ao implante de cateteres de longa permanência de inserção periférica, entre novembro de 2013 e junho de 2014, 35 pacientes consecutivos com doença oncológica ativa necessitando de quimioterapia. Os procedimentos foram realizados em centro cirúrgico por uma mesma equipe composta por três cirurgiões vasculares. Os desfechos primários avaliados foram as

  13. Effects of maternal sensitivity and cognitive and linguistic stimulation on cochlear implant users' language development over four years.

    PubMed

    Quittner, Alexandra L; Cruz, Ivette; Barker, David H; Tobey, Emily; Eisenberg, Laurie S; Niparko, John K

    2013-02-01

    To examine the effects of observed maternal sensitivity (MS), cognitive stimulation (CS), and linguistic stimulation on the 4-year growth of oral language in young, deaf children receiving a cochlear implant. Previous studies of cochlear implants have not considered the effects of parental behaviors on language outcomes. In this prospective, multisite study, we evaluated parent-child interactions during structured and unstructured play tasks and their effects on oral language development in 188 deaf children receiving a cochlear implant and 97 normal-hearing children as controls. Parent-child interactions were rated on a 7-point scale using the National Institute of Child Health and Human Development's Early Childcare Study codes, which have well-established psychometric properties. Language was assessed using the MacArthur Bates Communicative Development Inventories, the Reynell Developmental Language Scales, and the Comprehensive Assessment of Spoken Language. We used mixed longitudinal modeling to test our hypotheses. After accounting for early hearing experience and child and family demographics, MS and CS predicted significant increases in the growth of oral language. Linguistic stimulation was related to language growth only in the context of high MS. The magnitude of effects of MS and CS on the growth of language was similar to that found for age at cochlear implantation, suggesting that addressing parenting behaviors is a critical target for early language learning after implantation. Copyright © 2013 Mosby, Inc. All rights reserved.

  14. Fixation of the fully hydroxyapatite-coated Corail stem implanted due to femoral neck fracture: 38 patients followed for 2 years with RSA and DEXA.

    PubMed

    Schewelov, Thord von; Ahlborg, Henrik; Sanzén, Lennart; Besjakov, Jack; Carlsson, Ake

    2012-04-01

    Today, dislocated femoral neck fractures are commonly treated with a cemented hip arthroplasty. However, cementing of the femoral component may lead to adverse effects and even death. Uncemented stems may lower these risks and hydroxyapatite (HA) coating may enhance integration, but prosthetic stability and clinical outcome in patients with osteoporotic bone have not been fully explored. We therefore studied fixation and clinical outcome in patients who had had a femoral neck fracture and who had received a fully HA-coated stem prosthesis. 50 patients with a dislocated femoral neck fracture were operated with the fully HA-coated Corail total or hemiarthroplasty. 38 patients, mean age 81 (70-96) years, were followed for 24 months with conventional radiographs, RSA, DEXA, and for clinical outcome. 31 of the 38 implants moved statistically significantly up to 3 months, mainly distally, mean 2.7 mm (max. 20 mm (SD 4.3)), and rotated into retroversion mean 3.3º (-1.8 to 17) (SD 4.3) and then appeared to stabilize. Distal stem migration was more pronounced if the stem was deemed to be too small. There was no correlation between BMD and stem migration. The migration did not result in any clinically adverse effects. The fully hydroxyapatite-coated Corail stem migrates during the first 3 months, but clinical outcome appears to be good, without any adverse events.

  15. Auditory steady-state responses in cochlear implant users: Effect of modulation frequency and stimulation artifacts.

    PubMed

    Gransier, Robin; Deprez, Hanne; Hofmann, Michael; Moonen, Marc; van Wieringen, Astrid; Wouters, Jan

    2016-05-01

    Previous studies have shown that objective measures based on stimulation with low-rate pulse trains fail to predict the threshold levels of cochlear implant (CI) users for high-rate pulse trains, as used in clinical devices. Electrically evoked auditory steady-state responses (EASSRs) can be elicited by modulated high-rate pulse trains, and can potentially be used to objectively determine threshold levels of CI users. The responsiveness of the auditory pathway of profoundly hearing-impaired CI users to modulation frequencies is, however, not known. In the present study we investigated the responsiveness of the auditory pathway of CI users to a monopolar 500 pulses per second (pps) pulse train modulated between 1 and 100 Hz. EASSRs to forty-three modulation frequencies, elicited at the subject's maximum comfort level, were recorded by means of electroencephalography. Stimulation artifacts were removed by a linear interpolation between a pre- and post-stimulus sample (i.e., blanking). The phase delay across modulation frequencies was used to differentiate between the neural response and a possible residual stimulation artifact after blanking. Stimulation artifacts were longer than the inter-pulse interval of the 500pps pulse train for recording electrodes ipsilateral to the CI. As a result the stimulation artifacts could not be removed by artifact removal on the bases of linear interpolation for recording electrodes ipsilateral to the CI. However, artifact-free responses could be obtained in all subjects from recording electrodes contralateral to the CI, when subject specific reference electrodes (Cz or Fpz) were used. EASSRs to modulation frequencies within the 30-50 Hz range resulted in significant responses in all subjects. Only a small number of significant responses could be obtained, during a measurement period of 5 min, that originate from the brain stem (i.e., modulation frequencies in the 80-100 Hz range). This reduced synchronized activity of brain stem

  16. DS147 improves pregnancy in mice with embryo implantation dysfunction induced by controlled ovarian stimulation.

    PubMed

    Deng, Shao-rong; Li, Jing; Zhang, Zhi-qiang; Li, Bing; Sheng, Li-li; Zeng, Jian-wu; Liu, Ya-ping; An, Song-lin; Wu, Yun-xia

    2013-08-01

    The study examined the effect of DS147, the bioactive component of the traditional herbal recipe Bangdeyun, on pregnancy in mice with embryo implantation dysfunction induced by controlled ovarian stimulation (COS), and the underlying mechanisms. Female mice were superovulated by intraperitoneal injection of 7.5 IU of pregnant mare serum gonadotropin (PMSG) followed by an additional injection of 7.5 IU hCG 48 h later to establish embryo implantation dysfunction (EID) model. Pregnant mice were randomly divided into normal control group, COS group and DS147-treated groups. The pregnancy rate and the average implantation site were obtained on pregnancy day 8 (PD8). The side effect of 200 mg/kg of DS147 on naturally pregnant mice was also observed. Further, the uterine and ovarian tissue samples were collected on PD5 for measuring their weights, observing the development of the endometrium and ovary, and detecting the endometrial expression of MMP-2, TIMP-2, CD34 and angiogenin (ANG). The female mice treated with DS147 at doses of 100 to 800 mg/kg showed a higher pregnancy rate than those in COS group, and the highest pregnancy rate of 83.3% occurred in the 200 mg/kg DS147-treated group. Moreover, no obvious side effect was found in mice treated with 200 mg/kg DS147 on PD8 and PD16. The ovarian and uterine weights, and the expression levels of MMP-2, ANG and CD34 were significantly increased in DS147-treated groups when compared with COS group. The TIMP-2 expression level was much lower in DS147-treated mice than in COS mice and the ratio of MMP-2/TIMP-2 was much higher in DS147-treated group than in COS group, and even higher than normal control group. In all, these findings suggest that DS147 may improve pregnancy in mice with COS-induced EID by promoting matrix degradation and angiogenesis, and improving the development of corpus luteum and endometrial decidualization around the implantation window.

  17. Feasibility of an ultra-low power digital signal processor platform as a basis for a fully implantable brain-computer interface system.

    PubMed

    Wang, Po T; Gandasetiawan, Keulanna; McCrimmon, Colin M; Karimi-Bidhendi, Alireza; Liu, Charles Y; Heydari, Payam; Nenadic, Zoran; Do, An H

    2016-08-01

    A fully implantable brain-computer interface (BCI) can be a practical tool to restore independence to those affected by spinal cord injury. We envision that such a BCI system will invasively acquire brain signals (e.g. electrocorticogram) and translate them into control commands for external prostheses. The feasibility of such a system was tested by implementing its benchtop analogue, centered around a commercial, ultra-low power (ULP) digital signal processor (DSP, TMS320C5517, Texas Instruments). A suite of signal processing and BCI algorithms, including (de)multiplexing, Fast Fourier Transform, power spectral density, principal component analysis, linear discriminant analysis, Bayes rule, and finite state machine was implemented and tested in the DSP. The system's signal acquisition fidelity was tested and characterized by acquiring harmonic signals from a function generator. In addition, the BCI decoding performance was tested, first with signals from a function generator, and subsequently using human electroencephalogram (EEG) during eyes opening and closing task. On average, the system spent 322 ms to process and analyze 2 s of data. Crosstalk (<;-65 dB) and harmonic distortion (~1%) were minimal. Timing jitter averaged 49 μs per 1000 ms. The online BCI decoding accuracies were 100% for both function generator and EEG data. These results show that a complex BCI algorithm can be executed on an ULP DSP without compromising performance. This suggests that the proposed hardware platform may be used as a basis for future, fully implantable BCI systems.

  18. The Effect of Cochlear-Implant-Mediated Electrical Stimulation on Spiral Ganglion Cells in Congenitally Deaf White Cats

    PubMed Central

    Chen, Iris; Limb, Charles J.

    2010-01-01

    It has long been observed that loss of auditory receptor cells is associated with the progressive degeneration of spiral ganglion cells. Chronic electrical stimulation via cochlear implantation has been used in an attempt to slow the rate of degeneration in cats neonatally deafened by ototoxic agents but with mixed results. The present study examined this issue using white cats with a history of hereditary deafness as an alternative animal model. Nineteen cats provided new data for this study: four normal-hearing cats, seven congenitally deaf white cats, and eight congenitally deaf white cats with unilateral cochlear implants. Data from additional cats were collected from the literature. Electrical stimulation began at 3 to 4 or 6 to 7 months after birth, and cats received stimulation for approximately 7 h a day, 5 days a week for 12 weeks. Quantitative analysis of spiral ganglion cell counts, cell density, and cell body size showed no marked improvement between cochlear-implanted and congenitally deaf subjects. Average ganglion cell size from cochlear-implanted and congenitally deaf cats was statistically similar and smaller than that of normal-hearing cats. Cell density from cats with cochlear implants tended to decrease within the upper basal and middle cochlear turns in comparison to congenitally deaf cats but remained at congenitally deaf levels within the lower basal and apical cochlear turns. These results provide no evidence that chronic electrical stimulation enhances spiral ganglion cell survival, cell density, or cell size compared to that of unstimulated congenitally deaf cats. Regardless of ganglion neuron status, there is unambiguous restoration of auditory nerve synapses in the cochlear nucleus of these cats implanted at the earlier age. PMID:20821032

  19. Statistical Shape Model Segmentation and Frequency Mapping of Cochlear Implant Stimulation Targets in CT

    PubMed Central

    Noble, Jack H.; Gifford, René H.; Labadie, Robert F.; Dawant, Benoît M.

    2013-01-01

    Cochlear implant (CI) surgery is considered standard of care treatment for severe hearing loss. CIs are currently programmed using a one-size-fits-all type approach. Individualized, position-based CI programming schemes have the potential to significantly improve hearing outcomes. This has not been possible because the position of stimulation targets is unknown due to their small size and lack of contrast in CT. In this work, we present a segmentation approach that relies on a weighted active shape model created using microCT scans of the cochlea acquired ex-vivo in which stimulation targets are visible. The model is fitted to the partial information available in the conventional CTs and used to estimate the position of structures not visible in these images. Quantitative evaluation of our method results in Dice scores averaging 0.77 and average surface errors of 0.15 mm. These results suggest that our approach can be used for position-dependent image-guided CI programming methods. PMID:23286076

  20. Implanted electro-acupuncture electric stimulation improves outcome of stem cells' transplantation in spinal cord injury.

    PubMed

    Liu, Haichun; Yang, Kaiyun; Xin, Tao; Wu, Wenliang; Chen, Yunzhen

    2012-10-01

    Spinal cord injury (SCI) is one of the most serious disorders in clinics, and the high disability rate and functional deficits are common issues in patients. Transplantation of bone-marrow-derived mesenchymal stromal cells (BMSCs) into the injured spinal cord is emerging as a novel method in the therapeutics of SCI; however, its application is limited by the poor survival rate of the transplanted cells and low differentiation rate into neurons. Our laboratory recently reported that electrical stimulation (ES) dramatically improves the survival rate of transplanted BMSCs and increases spinal cord functions in animals with spinal cord injury. In this paper, we asked whether implanted electro-acupuncture (iEA) can advance the beneficial effects from the ES treatment in animals with spinal cord injury. We showed that BMSCs transplantation alone resulted in significant functional recovery in animals. Interestingly, iEA with BMSCs treatment induced a significantly higher functional improvement in locomotor functions and SSEP compared to the BMSCs treatment alone. Additionally, we used molecular biology techniques and showed that BMSCs transplantation with iEA treatment significantly increased the number of surviving BMSCs compared to the BMSCs alone group. In conclusion, our experiment showed that the approach of coupling iEA electric stimulation and BMSCs transplantation remarkably promotes functional improvements in animals with spinal cord injury and holds promising potential to treat spinal cord injury in humans.

  1. Influence of implantation on the electrochemical properties of smooth and porous TiN coatings for stimulation electrodes

    NASA Astrophysics Data System (ADS)

    Meijs, S.; Sørensen, C.; Sørensen, S.; Rechendorff, K.; Fjorback, M.; Rijkhoff, N. J. M.

    2016-04-01

    Objective. To determine whether changes in electrochemical properties of porous titanium nitride (TiN) electrodes as a function of time after implantation are different from those of smooth TiN electrodes. Approach. Eight smooth and 8 porous TiN coated electrodes were implanted in 8 rats. Before implantation, voltage transients, cyclic voltammograms and impedance spectra were recorded in phosphate buffered saline (PBS). After implantation, these measurements were done weekly to investigate how smooth and porous electrodes were affected by implantation. Main results. The electrode capacitance of the porous TiN electrodes decreased more than the capacitance of the smooth electrodes due to acute implantation under fast measurement conditions (such as stimulation pulses). This indicates that protein adhesion presents a greater diffusion limitation for counter-ions for the porous than for the smooth electrodes. The changes in electrochemical properties during the implanted period were similar for smooth and porous TiN electrodes, indicating that cell adhesion poses a similar diffusion limitation for smooth and porous electrodes. Significance. This knowledge can be used to optimize the porous structure of the TiN film, so that the effect of protein adhesion on the electrochemical properties is diminished. Alternatively, an additional coating could be applied on the porous TiN that would prevent or minimize protein adhesion.

  2. Cochlear Implant Electrode Effect on Sound Energy Transfer Within the Cochlea During Acoustic Stimulation.

    PubMed

    Greene, Nathaniel T; Mattingly, Jameson K; Jenkins, Herman A; Tollin, Daniel J; Easter, James R; Cass, Stephen P

    2015-09-01

    Cochlear implants (CIs) designed for hearing preservation will not alter mechanical properties of the middle and inner ears as measured by intracochlear pressure (P(IC)) and stapes velocity (Vstap). CIs designed to provide combined electroacoustic stimulation are now available. To maintain functional acoustic hearing, it is important to know if a CI electrode can alter middle or inner ear mechanics because any alteration could contribute to elevated low-frequency thresholds in electroacoustic stimulation patients. Seven human cadaveric temporal bones were prepared, and pure-tone stimuli from 120 Hz to 10 kHz were presented at a range of intensities up to 110 dB sound pressure level. P(IC) in the scala vestibuli (P(SV)) and tympani (PST) were measured with fiber-optic pressure sensors concurrently with VStap using laser Doppler vibrometry. Five CI electrodes from two different manufacturers with varying dimensions were inserted via a round window approach at six different depths (16-25 mm). The responses of P(IC) and VStap to acoustic stimulation were assessed as a function of stimulus frequency, normalized to sound pressure level in the external auditory canal, at baseline and electrode-inserted conditions. Responses measured with electrodes inserted were generally within approximately 5 dB of baseline, indicating little effect of CI electrode insertion on P(IC) and VStap. Overall, mean differences across conditions were small for all responses, and no substantial differences were consistently visible across electrode types. Results suggest that the influence of a CI electrode on middle and inner ear mechanics is minimal despite variation in electrode lengths and configurations.

  3. Package architecture and component design for an implanted neural stimulator with closed loop control.

    PubMed

    Bjune, Caroline K; Marinis, Thomas F; Brady, Jeanne M; Moran, James; Wheeler, Jesse; Sriram, Tirunelveli S; Parks, Philip D; Widge, Alik S; Dougherty, Darin D; Eskandar, Emad N

    2015-08-01

    An implanted neural stimulator with closed loop control requires electrodes for stimulation pulses and recording neuron activity. Our system features arrays of 64 electrodes. Each electrode can be addressed through a cross bar switch, to enable it to be used for stimulation or recording. This electrode switch, a bank of low noise amplifiers with an integrated analog to digital converter, power conditioning electronics, and a communications and control gate array are co-located with the electrode array in a 14 millimeter diameter satellite package that is designed to be flush mounted in a skull burr hole. Our system features five satellite packages connected to a central hub processor-controller via ten conductor cables that terminate in a custom designed, miniaturized connector. The connector incorporates features of high reliability, military grade devices and utilizes three distinct seals to isolate the contacts from fluid permeation. The hub system is comprised of a connector header, hermetic electronics package, and rechargeable battery pack, which are mounted on and electrically interconnected by a flexible circuit board. The assembly is over molded with a compliant silicone rubber. The electronics package contains two antennas, a large coil, used for recharging the battery and a high bandwidth antenna that is used to download data and update software. The package is assembled from two machined alumina pieces, a flat base with brazed in, electrical feed through pins and a rectangular cover with rounded corners. Titanium seal rings are brazed onto these two pieces so that they can be sealed by laser welding. A third system antenna is incorporated in the flexible circuit board. It is used to communicate with an externally worn control package, which monitors the health of the system and allows both the user and clinician to control or modify various system function parameters.

  4. Perceptual Spaces Induced by Cochlear Implant All-Polar Stimulation Mode

    PubMed Central

    McKay, Colette M.

    2016-01-01

    It has been argued that a main limitation of the cochlear implant is the spread of current induced by each electrode, which activates an inappropriately large range of sensory neurons. To reduce this spread, an alternative stimulation mode, the all-polar mode, was tested with five participants. It was designed to activate all the electrodes simultaneously with appropriate current levels and polarities to recruit narrower regions of auditory nerves at specific intracochlear electrode positions (denoted all-polar electrodes). In this study, the all-polar mode was compared with the current commercial stimulation mode: the monopolar mode. The participants were asked to judge the sound dissimilarity between pairs of two-electrode pulse-train stimuli that differed in the electrode positions and were presented in either monopolar or all-polar mode with pulses on the two electrodes presented either sequentially or simultaneously. The dissimilarity ratings were analyzed using a multidimensional scaling technique and three-dimensional stimulus perceptual spaces were produced. For all the conditions (mode and simultaneity), the first perceptual dimension was highly correlated with the position of the most apical activated electrode of the electrical stimulation and the second dimension with the position of the most basal electrode. In both sequential and simultaneous conditions, the monopolar and all-polar stimuli were significantly separated by a third dimension, which may indicate that all-polar stimuli have a perceptual quality that differs from monopolar stimuli. Overall, the results suggest that both modes might successfully represent spectral information in a sound processing strategy. PMID:27604784

  5. Associations Between Pre-Implant Psychosocial Factors and Spinal Cord Stimulation Outcome: Evaluation Using the MMPI-2-RF.

    PubMed

    Block, Andrew R; Marek, Ryan J; Ben-Porath, Yossef S; Kukal, Deborah

    2017-01-01

    Spinal cord stimulation (SCS) has variable effectiveness in controlling chronic pain. Previous research has demonstrated that psychosocial factors are associated with diminished results of SCS. The objective of this investigation is to examine associations between pre-implant psychological functioning as measured by the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) and SCS outcomes. SCS candidates at two sites (total N = 319) completed the MMPI-2-RF and measures of pain, emotional distress, and functional ability as part of a pre-implant psychological evaluation. At an average of 5 months post-implant, patients completed the measures of pain and emotional distress a second time. Poorer SCS outcomes and poorer patient satisfaction were associated with higher pre-implant MMPI-2-RF scores on scales used to assess emotional dysfunction, somatic/cognitive complaints, and interpersonal problems. Ways through which pre-implant psychological evaluations of spinal cord stimulator candidates can be informed by MMPI-2-RF findings are discussed. © The Author(s) 2015.

  6. Osseointegration of endosseous ceramic implants after postoperative low-power laser stimulation: an in vivo comparative study.

    PubMed

    Guzzardella, Gaetano A; Torricelli, Paola; Nicoli-Aldini, Nicolò; Giardino, Roberto

    2003-04-01

    Stimulation with low-power laser (LPL) can enhance bone repair as reported in experimental studies on bone defects and fracture healing. Little data exist concerning the use of LPL postoperative stimulation to improve osseointegration of endosseous implants in orthopaedic and dental surgery. An in vivo model was used for the present study to evaluate whether Ga-Al-As (780 nm) LPL stimulation can improve biomaterial osseointegration. After drilling holes, cylindrical implants of hydroxyapatite (HA) were placed into both distal femurs of 12 rabbits. From postoperative day 1 and for 5 consecutive days, the left femurs of all rabbits were submitted to LPL treatment (LPL group) with the following parameters: 300 J/cm2, 1 W, 300 Hz, pulsating emission, 10 min. The right femurs were sham-treated (control group). Three and 6 weeks after implantation, histomorphometric and microhardness measurements were taken. A higher affinity index was observed at the HA-bone interface in the LPL group at 3 (P<0.0005) and 6 weeks (P<0.001); a significant difference in bone microhardness was seen in the LPL group vs. the control group (P<0.01). These results suggest that LPL postoperative treatment enhances the bone-implant interface.

  7. Role of bimodal stimulation for auditory-perceptual skills development in children with a unilateral cochlear implant.

    PubMed

    Marsella, P; Giannantonio, S; Scorpecci, A; Pianesi, F; Micardi, M; Resca, A

    2015-12-01

    This is a prospective randomised study that evaluated the differences arising from a bimodal stimulation compared to a monaural electrical stimulation in deaf children, particularly in terms of auditory-perceptual skills development. We enrolled 39 children aged 12 to 36 months, suffering from severe-to-profound bilateral sensorineural hearing loss with residual hearing on at least one side. All were unilaterally implanted: 21 wore only the cochlear implant (CI) (unilateral CI group), while the other 18 used the CI and a contralateral hearing aid at the same time (bimodal group). They were assessed with a test battery designed to appraise preverbal and verbal auditory-perceptual skills immediately before and 6 and 12 months after implantation. No statistically significant differences were observed between groups at time 0, while at 6 and 12 months children in the bimodal group had better scores in each test than peers in the unilateral CI group. Therefore, although unilateral deafness/hearing does not undermine hearing acuity in normal listening, the simultaneous use of a CI and a contralateral hearing aid (binaural hearing through a bimodal stimulation) provides an advantage in terms of acquisition of auditory-perceptual skills, allowing children to achieve the basic milestones of auditory perception faster and in greater number than children with only one CI. Thus, "keeping awake" the contralateral auditory pathway, albeit not crucial in determining auditory acuity, guarantees benefits compared with the use of the implant alone. These findings provide initial evidence to establish shared guidelines for better rehabilitation of patients undergoing unilateral cochlear implantation, and add more evidence regarding the correct indications for bilateral cochlear implantation.

  8. Gastric electrical stimulation treatment of type 2 diabetes: effects of implantation versus meal-mediated stimulation. A randomized blinded cross-over trial

    PubMed Central

    Lebovitz, Harold E; Ludvik, Bernhard; Kozakowski, Jaroslaw; Tarnowski, Wieslaw; Zelewski, Mateusz; Yaniv, Irit; Schwartz, Tse’ela

    2015-01-01

    Gastric electrical stimulation with the implanted DIAMOND device has been shown to improve glycemic control and decrease weight and systolic blood pressure in patients with type 2 diabetes inadequately controlled with oral antidiabetic agents. The objective of this study was to determine if device implantation alone (placebo effect) contributes to the long-term metabolic benefits of DIAMOND® meal-mediated gastric electrical stimulation in patients with type 2 diabetes. The study was a 48 week randomized, blinded, cross-over trial in university centers comparing glycemic improvement of DIAMOND® implanted patients with type 2 diabetic with no activation of the electrical stimulation (placebo) versus meal-mediated activation of the electrical signal. The endpoint was improvement in glycemic control (HbA1c) from baseline to 24 and 48 weeks. In period 1 (0–24 weeks), equal improvement in HbA1c occurred independent of whether the meal-mediated electrical stimulation was turned on or left off (HbA1c −0.80% and −0.85% [−8.8 and −9.0 mmol/mol]). The device placebo improvement proved to be transient as it was lost in period 2 (25–48 weeks). With electrical stimulation turned off, HbA1c returned toward baseline values (8.06 compared to 8.32%; 64.2 to 67.4 mmol/mol, P = 0.465). In contrast, turning the electrical stimulation on in period 2 sustained the decrease in HbA1c from baseline (−0.93%, −10.1mmol/mol, P = 0.001) observed in period 1. The results indicate that implantation of the DIAMOND device causes a transient improvement in HbA1c which is not sustained beyond 24 weeks. Meal-mediated electrical stimulation accounts for the significant improvement in HbA1c beyond 24 weeks. PMID:26177957

  9. Simultaneous masking between electric and acoustic stimulation in cochlear implant users with residual low-frequency hearing.

    PubMed

    Krüger, Benjamin; Büchner, Andreas; Nogueira, Waldo

    2017-09-01

    Ipsilateral electric-acoustic stimulation (EAS) is becoming increasingly important in cochlear implant (CI) treatment. Improvements in electrode designs and surgical techniques have contributed to improved hearing preservation during implantation. Consequently, CI implantation criteria have been expanded toward people with significant residual low-frequency hearing, who may benefit from the combined use of both the electric and acoustic stimulation in the same ear. However, only few studies have investigated the mutual interaction between electric and acoustic stimulation modalities. This work characterizes the interaction between both stimulation modalities using psychophysical masking experiments and cone beam computer tomography (CBCT). Two psychophysical experiments for electric and acoustic masking were performed to measure the hearing threshold elevation of a probe stimulus in the presence of a masker stimulus. For electric masking, the probe stimulus was an acoustic tone while the masker stimulus was an electric pulse train. For acoustic masking, the probe stimulus was an electric pulse train and the masker stimulus was an acoustic tone. Five EAS users, implanted with a CI and ipsilateral residual low-frequency hearing, participated in the study. Masking was determined at different electrodes and different acoustic frequencies. CBCT scans were used to determine the individual place-pitch frequencies of the intracochlear electrode contacts by using the Stakhovskaya place-to-frequency transformation. This allows the characterization of masking as a function of the difference between electric and acoustic stimulation sites, which we term the electric-acoustic frequency difference (EAFD). The results demonstrate a significant elevation of detection thresholds for both experiments. In electric masking, acoustic-tone thresholds increased exponentially with decreasing EAFD. In contrast, for the acoustic masking experiment, threshold elevations were present

  10. Deep brain stimulation in the setting of cochlear implants: Case report and literature review

    PubMed Central

    Buell, Thomas J.; Ksendzovsky, Alexander; Shah, Binit B.; Kesser, Bradley W.; Elias, W. Jeffrey

    2015-01-01

    Background/Aims As technology continues to advance for our aging population, an increasing number of DBS candidates will have preexisting implanted electrical devices. In this article, we discuss safe and successful DBS in a patient with Parkinson's disease (PD) and bilateral cochlear implants. Methods A 70 year-old male with PD and bilateral cochlear implants underwent successful microelectrode-guided DBS implantation into bilateral subthalamic nuclei (STN). The patient's cochlear implant magnets were removed and replaced in outpatient clinic for pre-operative MRI and stereotactic targeting. The cochlear implants were turned off intraoperatively for STN microelectrode recordings. Results Precise, MRI-guided stereotactic DBS implantation was possible. Intraoperative high-fidelity microelectrode recordings confirmed STN neurons with the cochlear implants turned off. These recordings were not possible with active cochlear implant devices. Our literature review describes the other approaches/techniques that have been used to manage DBS surgery in the setting of cochlear implants. Conclusions Despite the risk of electrical interference between implanted medical devices, DBS and cochlear implants may be safe and compatible in the same patient if necessary precautions are taken. PMID:25998722

  11. First-in-Man Demonstration of Fully Implanted Myoelectric Sensors for Control of an Advanced Electromechanical Arm by Transradial Amputees

    PubMed Central

    Pasquina, Paul F.; Evangelista, Melissa; Carvalho, Antonio J.; Lockhart, Joseph; Griffin, Sarah; Nanos, George; McKay, Patricia; Hansen, Morten; Ipsen, Derek; Vandersea, James; Butkus, Josef; Miller, Matthew; Murphy, Ian; Hankin, David

    2014-01-01

    Background Advanced motorized prosthetic devices are currently controlled by EMG signals generated by residual muscles and recorded by surface electrodes on the skin. These surface recordings are often inconsistent and unreliable, leading to high prosthetic abandonment rates for individuals with upper limb amputation. Surface electrodes are limited because of poor skin contact, socket rotation, residual limb sweating, and their ability to only record signals from superficial muscles, whose function frequently does not relate to the intended prosthetic function. More sophisticated prosthetic devices require a stable and reliable interface between the user and robotic hand to improve upper limb prosthetic function. New Method Implantable Myoelectric Sensors (IMES®) are small electrodes intended to detect and wirelessly transmit EMG signals to an electromechanical prosthetic hand via an electromagnetic coil built into the prosthetic socket. This system is designed to simultaneously capture EMG signals from multiple residual limb muscles, allowing the natural control of multiple degrees of freedom simultaneously. Results We report the status of the first FDA-approved clinical trial of the IMES® System. This study is currently in progress, limiting reporting to only preliminary results. Comparison with Existing Methods Our first subject has reported the ability to accomplish a greater variety and complexity of tasks in his everyday life compared to what could be achieved with his previous myoelectric prosthesis. Conclusion The interim results of this study indicate the feasibility of utilizing IMES® technology to reliably sense and wirelessly transmit EMG signals from residual muscles to intuitively control a three degree-of-freedom prosthetic arm. PMID:25102286

  12. First-in-man demonstration of a fully implanted myoelectric sensors system to control an advanced electromechanical prosthetic hand.

    PubMed

    Pasquina, Paul F; Evangelista, Melissa; Carvalho, A J; Lockhart, Joseph; Griffin, Sarah; Nanos, George; McKay, Patricia; Hansen, Morten; Ipsen, Derek; Vandersea, James; Butkus, Josef; Miller, Matthew; Murphy, Ian; Hankin, David

    2015-04-15

    Advanced motorized prosthetic devices are currently controlled by EMG signals generated by residual muscles and recorded by surface electrodes on the skin. These surface recordings are often inconsistent and unreliable, leading to high prosthetic abandonment rates for individuals with upper limb amputation. Surface electrodes are limited because of poor skin contact, socket rotation, residual limb sweating, and their ability to only record signals from superficial muscles, whose function frequently does not relate to the intended prosthetic function. More sophisticated prosthetic devices require a stable and reliable interface between the user and robotic hand to improve upper limb prosthetic function. Implantable Myoelectric Sensors (IMES(®)) are small electrodes intended to detect and wirelessly transmit EMG signals to an electromechanical prosthetic hand via an electro-magnetic coil built into the prosthetic socket. This system is designed to simultaneously capture EMG signals from multiple residual limb muscles, allowing the natural control of multiple degrees of freedom simultaneously. We report the status of the first FDA-approved clinical trial of the IMES(®) System. This study is currently in progress, limiting reporting to only preliminary results. Our first subject has reported the ability to accomplish a greater variety and complexity of tasks in his everyday life compared to what could be achieved with his previous myoelectric prosthesis. The interim results of this study indicate the feasibility of utilizing IMES(®) technology to reliably sense and wirelessly transmit EMG signals from residual muscles to intuitively control a three degree-of-freedom prosthetic arm. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. Auditory training in patients with unilateral cochlear implant and contralateral acoustic stimulation

    PubMed Central

    Zhang, Ting; Dorman, Michael F.; Fu, Qian-Jie; Spahr, Anthony J.

    2012-01-01

    Objectives The hypothesis of the present study was that auditory training would allow bimodal patients to better combine the low-frequency acoustic information provided by a hearing aid (HA) with the electric information provided by a cochlear implant (CI), thus maximizing the benefit of combining acoustic (A) and electric (E) stimulation (EAS). Design Performance in quiet or in the presence of a multi-talker babble at + 5 dB SNR was evaluated in seven bimodal patients before and after auditory training. The performance measures comprised identification of vowels and consonants, CNC words, sentences, voice gender, and emotion. Baseline performance was evaluated in the A-alone, E-alone, and combined EAS conditions once per week for three weeks. A phonetic-contrast training protocol was used to facilitate speech perceptual learning. Patients trained at home 1 hour/day, 5 days/week, for 4 weeks with both their CI and HA devices on. Performance was re-measured after the 4th weeks of training and one month after training stopped. Results After training, there was significant improvement in vowel, consonant, and CNC word identification in the E and EAS conditions. The magnitude of improvement in the E condition was equivalent to that in the EAS condition. The improved performance was largely retained one month after training stopped. Conclusion Auditory training, in the form administered in this study, can improve bimodal patients’ overall speech understanding by improving E-alone performance. PMID:22622705

  14. Evaluation of a cochlear-implant processing strategy incorporating phantom stimulation and asymmetric pulses

    PubMed Central

    Monstrey, Jolijn; Deeks, John M.; Macherey, Olivier

    2014-01-01

    Objective To evaluate a speech-processing strategy in which the lowest frequency channel is conveyed using an asymmetric pulse shape and “phantom stimulation”, where current is injected into one intra-cochlear electrode and where the return current is shared between an intra-cochlear and an extra-cochlear electrode. This strategy is expected to provide more selective excitation of the cochlear apex, compared to a standard strategy where the lowest-frequency channel is conveyed by symmetric pulses in monopolar mode. In both strategies all other channels were conveyed by monopolar stimulation. Design Within-subjects comparison between the two strategies. Four experiments: (1) discrimination between the strategies, controlling for loudness differences, (2) consonant identification, (3) recognition of lowpass-filtered sentences in quiet, (4) sentence recognition in the presence of a competing speaker. Study sample Eight users of the Advanced Bionics CII/Hi-Res 90k cochlear implant. Results Listeners could easily discriminate between the two strategies but no consistent differences in performance were observed. Conclusions The proposed method does not improve speech perception, at least in the short term. PMID:25358027

  15. Factors affecting predicted speech intelligibility with cochlear implants in an auditory model for electrical stimulation.

    PubMed

    Fredelake, Stefan; Hohmann, Volker

    2012-05-01

    A model of the auditory response to stimulation with cochlear implants (CIs) was used to predict speech intelligibility in electric hearing. The model consists of an auditory nerve cell population that generates delta pulses as action potentials in response to temporal and spatial excitation with a simulated CI signal processing strategy. The auditory nerve cells are modeled with a leaky integrate-and-fire model with membrane noise. Refractory behavior is introduced by raising the threshold potential with an exponentially decreasing function. Furthermore, the action potentials are delayed to account for latency and jitter. The action potentials are further processed by a central model stage, which includes spatial and temporal integration, resulting in an internal representation of the sound presented. Multiplicative noise is included in the internal representations to limit resolution. Internal representations of complete word sets for a sentence intelligibility test were computed and classified using a Dynamic-Time-Warping classifier to quantify information content and to estimate speech intelligibility. The number of auditory nerve cells, the spatial spread of the electrodes' electric field, and the internal noise intensity were found to have a major impact on the modeled speech intelligibility, whereas the influence of refractory behavior, membrane noise, and latency and jitter was minor. Copyright © 2012 Elsevier B.V. All rights reserved.

  16. Do we need to establish guidelines for patients with neuromodulation implantable devices, including spinal cord stimulators undergoing nonspinal surgeries?

    PubMed Central

    Ghaly, Ramsis F.; Tverdohleb, Tatiana; Candido, Kenneth D.; Knezevic, Nebojsa Nick

    2016-01-01

    Background: Spinal cord stimulation is currently approved to treat chronic intractable pain of the trunk and limbs. However, such implantable electronic devices are vulnerable to external electrical currents and magnetic fields. Within the hospitals and modern operating rooms (ORs), there is an abundance of electrical devices and other types of equipment that could interfere with such devices. Despite the increasing number of patients with neuromodulation implantable devices, there are no written guidelines available or consensus of cautions for such patients undergoing unrelated surgery. Case Descriptions: A 60-year-old female with a permanent St. Jude's spinal cord stimulator (SCS) presented for open total abdominal hysterectomy. Both the anesthesia and gynecology staffs were aware of the device presence, but were unaware of any precautions regarding intraoperative management. The device was found to be nonmagnetic resonance imaging compatible, and bipolar cautery was used instead of monopolar cautery. A 59-year-old female with a 9-year-old permanent Medtronic SCS, presented for right total hip arthroplasty. The device was switched off prior to entering the OR, bipolar cautery was used, and grounding pads were placed away from her battery site. In each case, the manufacturer's representative was contacted preoperative. Both surgeries proceeded uneventfully. Conclusions: The Food and Drug Administration safety information manual warns about the use of diathermy, concomitant implanted stimulation devices, lithotripsy, external defibrillation, radiation therapy, ultrasonic scanning, and high-output ultrasound, all of which can lead to permanent implant damage if not turned off prior to undertaking procedures. Lack of uniform guidelines makes intraoperative management, as well as remote anesthesia care of patients with previously implanted SCSs unsafe. PMID:26958424

  17. Active books: the design of an implantable stimulator that minimizes cable count using integrated circuits very close to electrodes.

    PubMed

    Liu, Xiao; Demosthenous, Andreas; Vanhoestenberghe, Anne; Jiang, Dai; Donaldson, Nick

    2012-06-01

    This paper presents an integrated stimulator that can be embedded in implantable electrode books for interfacing with nerve roots at the cauda equina. The Active Book overcomes the limitation of conventional nerve root stimulators which can only support a small number of stimulating electrodes due to cable count restriction through the dura. Instead, a distributed stimulation system with many tripole electrodes can be configured using several Active Books which are addressed sequentially. The stimulator was fabricated in a 0.6-μm high-voltage CMOS process and occupies a silicon area of 4.2 × 6.5 mm(2). The circuit was designed to deliver up to 8 mA stimulus current to tripole electrodes from an 18 V power supply. Input pad count is limited to five (two power and three control lines) hence requiring a specific procedure for downloading stimulation commands to the chip and extracting information from it. Supported commands include adjusting the amplitude of stimulus current, varying the current ratio at the two anodes in each channel, and measuring relative humidity inside the chip package. In addition to stimulation mode, the chip supports quiescent mode, dissipating less than 100 nA current from the power supply. The performance of the stimulator chip was verified with bench tests including measurements using tripoles in saline.

  18. Characterization of pulse amplitude and pulse rate modulation for a human vestibular implant during acute electrical stimulation

    NASA Astrophysics Data System (ADS)

    Nguyen, T. A. K.; DiGiovanna, J.; Cavuscens, S.; Ranieri, M.; Guinand, N.; van de Berg, R.; Carpaneto, J.; Kingma, H.; Guyot, J.-P.; Micera, S.; Perez Fornos, A.

    2016-08-01

    Objective. The vestibular system provides essential information about balance and spatial orientation via the brain to other sensory and motor systems. Bilateral vestibular loss significantly reduces quality of life, but vestibular implants (VIs) have demonstrated potential to restore lost function. However, optimal electrical stimulation strategies have not yet been identified in patients. In this study, we compared the two most common strategies, pulse amplitude modulation (PAM) and pulse rate modulation (PRM), in patients. Approach. Four subjects with a modified cochlear implant including electrodes targeting the peripheral vestibular nerve branches were tested. Charge-equivalent PAM and PRM were applied after adaptation to baseline stimulation. Vestibulo-ocular reflex eye movement responses were recorded to evaluate stimulation efficacy during acute clinical testing sessions. Main results. PAM evoked larger amplitude eye movement responses than PRM. Eye movement response axes for lateral canal stimulation were marginally better aligned with PRM than with PAM. A neural network model was developed for the tested stimulation strategies to provide insights on possible neural mechanisms. This model suggested that PAM would consistently cause a larger ensemble firing rate of neurons and thus larger responses than PRM. Significance. Due to the larger magnitude of eye movement responses, our findings strongly suggest PAM as the preferred strategy for initial VI modulation.

  19. Psychophysically based site selection coupled with dichotic stimulation improves speech recognition in noise with bilateral cochlear implants.

    PubMed

    Zhou, Ning; Pfingst, Bryan E

    2012-08-01

    The ability to perceive important features of electrical stimulation varies across stimulation sites within a multichannel implant. The aim of this study was to optimize speech processor MAPs for bilateral implant users by identifying and removing sites with poor psychophysical performance. The psychophysical assessment involved amplitude-modulation detection with and without a masker, and a channel interaction measure quantified as the elevation in modulation detection thresholds in the presence of the masker. Three experimental MAPs were created on an individual-subject basis using data from one of the three psychophysical measures. These experimental MAPs improved the mean psychophysical acuity across the electrode array and provided additional advantages such as increasing spatial separations between electrodes and/or preserving frequency resolution. All 8 subjects showed improved speech recognition in noise with one or more experimental MAPs over their everyday-use clinical MAP. For most subjects, phoneme and sentence recognition in noise were significantly improved by a dichotic experimental MAP that provided better mean psychophysical acuity, a balanced distribution of selected stimulation sites, and preserved frequency resolution. The site-selection strategies serve as useful tools for evaluating the importance of psychophysical acuities needed for good speech recognition in implant users.

  20. Diaphragm pacing after bilateral implantation of intradiaphragmatic phrenic stimulation electrodes through a transmediastinal endoscopic minimally invasive approach: pilot animal data.

    PubMed

    Assouad, Jalal; Masmoudi, Hicham; Gonzalez-Bermejo, Jesus; Morélot-Panzini, Capucine; Diop, Moustapha; Grunenwald, Dominique; Similowski, Thomas

    2012-08-01

    Phrenic nerve stimulation for diaphragm pacing allows patients with central respiratory paralysis to be weaned from mechanical ventilation. Two procedures are available, either intrathoracic (bilateral thoracotomy) or intradiaphragmatic (four ports laparoscopy). The present experimental work assesses the feasibility, safety and efficacy of a trans-mediastinal implantation of intradiaphragmatic phenic nerve stimulation electrodes using a flexible gastroscope through a cervical incision. We operated on nine ewes. After selective bronchial intubation, we dissected the latero-tracheal space and opened both mediastinal pleura. We then introduced a flexible gastroscope into the pleural cavities, in a sequential manner. The phrenic nerves were located and followed up to the diaphragm dome. Electrodes loaded within a long, pliable needle were introduced through the adjacent intercostal space and implanted in each hemidiaphragm, at a 'tendinous' location (as close as possible to the entry of the nerve in the central tendon), and at a more lateral 'muscular' location. Postoperatively, the animals were ventilated using bilateral phrenic nerve stimulation. After euthanasia, abdominal verification of the electrodes position was performed through a laparotomy. The mediastinal and pleural parts of the procedure were uneventful. The insertion of electrodes was associated with transdiaphragmatic puncture and small abdominal haematomas in the first two animals studied. After a slight modification of the insertion technique, this was not observed anymore. Phrenic nerve stimulation produced efficient ventilation, with tidal volumes significantly higher when delivered at the tendinous site than at the muscular site. The trans-mediastinal implantation of intradiaphragmatic phrenic nerve stimulation electrodes is feasible, appears reasonably safe, and allows efficient ventilation.

  1. Exhausted implanted pulse generator in sacral nerve stimulation for faecal incontinence: What next in daily practice for patients?

    PubMed

    Duchalais, Emilie; Meurette, Guillaume; Perrot, Bastien; Wyart, Vincent; Kubis, Caroline; Lehur, Paul-Antoine

    2016-02-01

    The efficacy of sacral nerve stimulation in faecal incontinence relies on an implanted pulse generator known to have a limited lifespan. The long-term use of sacral nerve stimulation raises concerns about the true lifespan of generators. The aim of the study was to assess the lifespan of sacral nerve stimulation implanted pulse generators in daily practice, and the outcome of exhausted generator replacement, in faecal incontinent patients. Faecal incontinent patients with pulse generators (Medtronic Interstim™ or InterstimII™) implanted in a single centre from 2001 to 2014 were prospectively followed up. Generator lifespan was measured according to the Kaplan-Meier method. Patients with a generator explanted/turned off before exhaustion were excluded. Morbidity of exhausted generator replacement and the outcome (Cleveland Clinic Florida Faecal Incontinence (CCF-FI) and Faecal Incontinence Quality of Life (FIQL) scores) were recorded. Of 135 patients with an implanted pulse generator, 112 (InterstimII 66) were included. Mean follow-up was 4.9 ± 2.8 years. The generator reached exhaustion in 29 (26%) cases. Overall median lifespan of an implanted pulse generator was approximately 9 years (95% CI 8-9.2). Interstim and InterstimII 25th percentile lifespan was 7.2 (CI 6.4-8.3) and 5 (CI 4-not reached) years, respectively. After exhaustion, generators were replaced, left in place or explanted in 23, 2 and 4 patients, respectively. Generator replacement was virtually uneventful. CCF-FI/FIQL scores remained unchanged after generator replacement (CCF-FI 8 ± 2 vs 7 ± 3; FIQL 3 ± 0.6 vs 3 ± 0.5; p = ns). In this study, the implanted pulse generator observed median lifespan was 9 years. After exhaustion, generators were safely and efficiently replaced. The study also gives insight into long-term needs and costs of sacral nerve stimulation (SNS) therapy.

  2. A good preoperative response to transcutaneous electrical nerve stimulation predicts a better therapeutic effect of implanted occipital nerve stimulation in pharmacologically intractable headaches.

    PubMed

    Nguyen, Jean-Paul; Nizard, Julien; Kuhn, Emmanuelle; Carduner, Florence; Penverne, Frédérique; Verleysen-Robin, Marie-Christine; Terreaux, Luc; de Gaalon, Solène; Raoul, Sylvie; Lefaucheur, Jean-Pascal

    2016-02-01

    Occipital nerve stimulation (ONS) is a surgical approach to treat patients with medically intractable chronic headache disorders. However, no preoperative test has been yet validated to allow candidates to be selected for implantation. In this study, the analgesic efficacy of transcutaneous electrical nerve stimulation (TENS) was tested for 1 to 3 months in 41 patients with pharmacologically intractable headache disorders of various origins, using a new technique of electrode placement over the occipital nerve. ONS electrodes were subsequently implanted in 33 patients (occipital neuralgia [n=15], cervicogenic headache [n=7], cluster headache [n=6], chronic migraine [n=5]) who had responded at least moderately to TENS. Assessment was performed up to five years after implantation (three years on average), based on the mean and maximum daily pain intensity scored on a 0-10 visual analogue scale and the number of headache days per month. Both TENS and chronic ONS therapy were found to be efficacious (57-76% improvement compared to baseline on the various clinical variables). The efficacy of ONS was better in cases of good or very good preoperative response to TENS than in cases of moderate response to TENS. Implanted ONS may be a valuable therapeutic option in the long term for patients with pharmacologically intractable chronic headache. Although we cannot conclude in patients with poor or no response to TENS, a good or very good response to TENS can support the indication of ONS therapy. This preoperative test could particularly be useful in patients with chronic migraine, in whom it may be difficult to indicate an invasive technique of cranial neurostimulation.

  3. Neuromuscular electrical stimulation of the thighs in cardiac patients with implantable cardioverter defibrillators.

    PubMed

    Cenik, Fadime; Schoberwalter, Dieter; Keilani, Mohammad; Maehr, Bruno; Wolzt, Michael; Marhold, Maximilian; Crevenna, Richard

    2016-11-01

    The aim of this systematic review was to update scientific knowledge concerning the safety of neuromuscular electrical stimulation (NMES) to increase exercise capacity and prevent cardiac cachexia in patients with implantable cardioverter defibrillators (ICDs). A systematic review including the electronic databases PubMed, MEDLINE, and SCOPUS was conducted for the time period from 1966 to March 31, 2016. Only four articles fulfilled the inclusion criteria (three original articles/safety studies and one case report). The three (safety) studies used NMES to increase muscle strength and/or endurance capacity of the thighs. NMES did not show electromagnetic interference (EMI) with ICD function. EMI was described in a case report of 2 patients with subpectoral ICDs and application of NMES on abdominal muscles. This review indicates that NMES may be applied in cardiac ICD patients if 1) individual risks (e. g., pacing dependency, acute heart failure, unstable angina, ventricular arrhythmic episode in the last 3 months) are excluded by performing a safety check before starting NMES treatment and 2) "passive" exercise using NMES is performed only for thighs and gluteal muscles in 3) compliant ICD patients (especially for home-based NMES) and 4) the treatment is regularly supervised by a physician and the device is examined after the first use of NMES to exclude EMI. Nevertheless, further studies including larger sample sizes are necessary to exclude any risk when NMES is used in this patient group.

  4. Cathodic Electrical Stimulation Combined With Vancomycin Enhances Treatment of Methicillin-resistant Staphylococcus aureus Implant-associated Infections.

    PubMed

    Nodzo, Scott; Tobias, Menachem; Hansen, Lisa; Luke-Marshall, Nicole R; Cole, Ross; Wild, Linda; Campagnari, Anthony A; Ehrensberger, Mark T

    2015-09-01

    Effective treatments for implant-associated infections are often lacking. Cathodic voltage-controlled electrical stimulation has shown potential as a treatment of implant-associated infections of methicillin-resistant Staphylococcus aureus (MRSA). The primary purpose of this study was to (1) determine if cathodic voltage-controlled electrical stimulation combined with vancomycin therapy is more effective at reducing the MRSA bacterial burden on the implant, bone, and synovial fluid in comparison to either treatment alone or no treatment controls. We also sought to (2) evaluate the histologic effects of the various treatments on the surrounding bone; and to (3) determine if the cathodic voltage-controlled electrical stimulation treatment had an effect on the mechanical properties of the titanium implant as a result of possible hydrogen embrittlement. Thirty-two adult male Long-Evans rats (Harlan Laboratories, Indianapolis, IN, USA) with surgically placed shoulder titanium implants were infected with a clinical strain of MRSA (NRS70). One week after infection, eight animals received a treatment of cathodic voltage-controlled electrical stimulation at -1.8 V versus Ag/AgCl for 1 hour (STIM), eight received vancomycin twice daily for 1 week (VANCO), eight received the cathodic voltage-controlled electrical stimulation and vancomycin therapy combined (STIM + VANCO), and eight served as controls with no treatment (CONT). Two weeks after initial infection, the implant, bone, and synovial fluid were collected for colony-forming unit (CFU) enumeration, qualitative histological analysis by a pathologist blinded to the treatments each animal received, and implant three-point bend testing. The implant-associated CFU enumerated from the STIM + VANCO (mean, 3.7 × 10(3); SD, 6.3 × 10(3)) group were less than those from the CONT (mean, 1.3 × 10(6); SD, 2.8 × 10(6); 95% confidence interval [CI] of difference, -4.3 × 10(5) to -9.9 × 10(3); p < 0.001), STIM (mean, 1.4 × 10

  5. Vagus Nerve Stimulator Placement in Dogs: Surgical Implantation Technique, Complications, Long-Term Follow-Up, and Practical Considerations.

    PubMed

    Martlé, Valentine; Van Ham, Luc M L; Boon, Paul; Caemaert, Jacques; Tshamala, Mulenda; Vonck, Kristl; Raedt, Robrecht; Polis, Ingeborgh; Bhatti, Sofie

    2016-01-01

    To describe a modified implantation procedure of a vagus nerve stimulation (VNS) device in dogs and to report short- and long-term complications. Descriptive, experimental study. Healthy, adult Beagle dogs (n = 10). A VNS Therapy(®) System was implanted in the left cervical region of anesthetized dogs. During and within 48 hours after surgery, electrocardiography (ECG) and impedance testing of the system were performed. Dogs were monitored daily and the impedance of the system was determined regularly until VNS devices were surgically removed 3 years after implantation. The implantation procedure was successful in all dogs without intraoperative complications. ECG monitoring and impedance tests were within normal limits during and within 48 hours after surgery. Postoperative seroma formation was common (70%). One dog developed an irreversible Horner's syndrome leading to removal of the device 5 months after implantation. Another dog developed trauma-induced damage of the lead requiring surgical revision. The device could be safely removed in all dogs; however, electrodes were left in place to avoid nerve damage. At removal, the anchor tether was dislodged in 40% of dogs and the lead was twisted in 50% of dogs. Implantation of a VNS Therapy(®) System is safe and feasible in dogs; however, seroma formation, twisting of the lead, and dislodgement of the anchor tether were common. Practical improvements in the technique include stable device placement, use of a compression bandage, and exercise restriction. Regular evaluation of lead impedance is important, as altered values can indicate serious complications. © Copyright 2015 by The American College of Veterinary Surgeons.

  6. Ovarian stimulation using human chorionic gonadotrophin impairs blastocyst implantation and decidualization by altering ovarian hormone levels and downstream signaling in mice.

    PubMed

    Ezoe, Kenji; Daikoku, Takiko; Yabuuchi, Akiko; Murata, Nana; Kawano, Hiroomi; Abe, Takashi; Okuno, Takashi; Kobayashi, Tamotsu; Kato, Keiichi

    2014-11-01

    Ovarian stimulation induced by follicle-stimulating hormone and human chorionic gonadotrophin (hCG) is commonly used in assisted reproductive technology to increase embryo production. However, recent clinical and animal studies have shown that ovarian stimulation disrupts endometrial function and embryo development and adversely affects pregnancy outcomes. How ovarian stimulation impairs pregnancy establishment and the precise mechanisms by which this stimulation reduces the chances of conception remain unclear. In this study, we first demonstrated that ovarian stimulation using hCG alone impairs implantation, decidualization and fetal development of mice by generating abnormal ovarian hormone levels. We also showed that ovarian hormone levels were altered because of changes in the levels of the enzymes involved in their synthesis in the follicles and corpora lutea. Furthermore, we determined that anomalous ovarian hormone secretion induced by ovarian stimulation alters the spatiotemporal expression of progesterone receptors and their downstream genes, especially in the uterine epithelium. Epithelial estrogenic signaling and cell proliferation were promoted on the day of implantation in stimulated mice and these changes led to the failure of uterine transition from the prereceptive to the receptive state. Collectively, our findings indicate that ovarian stimulation using hCG induces an imbalance in steroid hormone secretion, which causes a failure of the development of uterine receptivity and subsequent implantation and decidualization by altering the expression of steroid receptors and their downstream signaling associated with embryo implantation.

  7. Effect of Stimulation Rate on Cochlear Implant Users’ Phoneme, Word and Sentence Recognition in Quiet and in Noise

    PubMed Central

    Shannon, Robert V.; Cruz, Rachel J.; Galvin, John J.

    2011-01-01

    High stimulation rates in cochlear implants (CI) offer better temporal sampling, can induce stochastic-like firing of auditory neurons and can increase the electric dynamic range, all of which could improve CI speech performance. While commercial CI have employed increasingly high stimulation rates, no clear or consistent advantage has been shown for high rates. In this study, speech recognition was acutely measured with experimental processors in 7 CI subjects (Clarion CII users). The stimulation rate varied between (approx.) 600 and 4800 pulses per second per electrode (ppse) and the number of active electrodes varied between 4 and 16. Vowel, consonant, consonant-nucleus-consonant word and IEEE sentence recognition was acutely measured in quiet and in steady noise (+10 dB signal-to-noise ratio). Subjective quality ratings were obtained for each of the experimental processors in quiet and in noise. Except for a small difference for vowel recognition in quiet, there were no significant differences in performance among the experimental stimulation rates for any of the speech measures. There was also a small but significant increase in subjective quality rating as stimulation rates increased from 1200 to 2400 ppse in noise. Consistent with previous studies, performance significantly improved as the number of electrodes was increased from 4 to 8, but no significant difference showed between 8, 12 and 16 electrodes. Altogether, there was little-to-no advantage of high stimulation rates in quiet or in noise, at least for the present speech tests and conditions. PMID:20639631

  8. Efficacy of Intrauterine infusion of granulocyte colony stimulating factor on patients with history of implantation failure: A randomized control trial

    PubMed Central

    Eftekhar, Maryam; Miraj, Sepideh; Farid Mojtahedi, Maryam; Neghab, Nosrat

    2016-01-01

    Background: Although pregnancy rate in in vitro fertilization-embryo transfer (IVF-ET) cycles has been increased over the preceding years, but the majority of IVF-ET cycles still fail. Granulocyte colony stimulating factor (GCSF) is a glycoprotein that stimulates cytokine growth factor and induces immune system which may improve pregnancy rate in women with history of implantation failure. Objective: The aim of this study was to evaluate GCSF ability to improve pregnancy rate in women with history of implantation failure Materials and Methods: 0.5 ml (300 µg/ml) GCSF was infused intrauterine in intervention group. Pregnancy outcomes were assessed based on clinical pregnancy. Results: The mean age of participants was 31.95±4.71 years old. There were no significant differences between demographic characteristics in two groups (p>0.05). The pregnancy outcome in GCSF group was improved significantly (p=0.043). Conclusion: GCSF can improve pregnancy outcome in patients with history of implantation failure. PMID:27981253

  9. Speech perception and localisation with SCORE bimodal: a loudness normalisation strategy for combined cochlear implant and hearing aid stimulation.

    PubMed

    Francart, Tom; McDermott, Hugh

    2012-01-01

    A significant fraction of newly implanted cochlear implant recipients use a hearing aid in their non-implanted ear. SCORE bimodal is a sound processing strategy developed for this configuration, aimed at normalising loudness perception and improving binaural loudness balance. Speech perception performance in quiet and noise and sound localisation ability of six bimodal listeners were measured with and without application of SCORE. Speech perception in quiet was measured either with only acoustic, only electric, or bimodal stimulation, at soft and normal conversational levels. For speech in quiet there was a significant improvement with application of SCORE. Speech perception in noise was measured for either steady-state noise, fluctuating noise, or a competing talker, at conversational levels with bimodal stimulation. For speech in noise there was no significant effect of application of SCORE. Modelling of interaural loudness differences in a long-term-average-speech-spectrum-weighted click train indicated that left-right discrimination of sound sources can improve with application of SCORE. As SCORE was found to leave speech perception unaffected or to improve it, it seems suitable for implementation in clinical devices.

  10. Laser Sintered Porous Ti-6Al-4V Implants Stimulate Vertical Bone Growth.

    PubMed

    Cheng, Alice; Cohen, David J; Kahn, Adrian; Clohessy, Ryan M; Sahingur, Kaan; Newton, Joseph B; Hyzy, Sharon L; Boyan, Barbara D; Schwartz, Zvi

    2017-04-13

    The objective of this study was to examine the ability of 3D implants with trabecular-bone-inspired porosity and micro-/nano-rough surfaces to enhance vertical bone ingrowth. Porous Ti-6Al-4V constructs were fabricated via laser-sintering and processed to obtain micro-/nano-rough surfaces. Male and female human osteoblasts were seeded on constructs to analyze cell morphology and response. Implants were then placed on rat calvaria for 10 weeks to assess vertical bone ingrowth, mechanical stability and osseointegration. All osteoblasts showed higher levels of osteocalcin, osteoprotegerin, vascular endothelial growth factor and bone morphogenetic protein 2 on porous constructs compared to solid laser-sintered controls. Porous implants placed in vivo resulted in an average of 3.1 ± 0.6 mm(3) vertical bone growth and osseointegration within implant pores and had significantly higher pull-out strength values than solid implants. New bone formation and pull-out strength was not improved with the addition of demineralized bone matrix putty. Scanning electron images and histological results corroborated vertical bone growth. This study indicates that Ti-6Al-4V implants fabricated by additive manufacturing to have porosity based on trabecular bone and post-build processing to have micro-/nano-surface roughness can support vertical bone growth in vivo, and suggests that these implants may be used clinically to increase osseointegration in challenging patient cases.

  11. Exploring the phosphoproteome profiles during Xenopus egg activation by calcium stimulation using a fully automated phosphopeptide purification system

    PubMed Central

    Kanno, Takuma; Furukawa, Kazuhiro; Horigome, Tsuneyoshi

    2016-01-01

    To explore the phosphoproteome profiles during Xenopus egg activation by Ca2+-stimulation, an automated phosphopeptide purification system involving a titania column was improved by introducing 4-step elution with phosphate buffers. The number of detected phosphopeptides in the tryptic digest of a Xenopus egg cytosol fraction on mass spectrometry (MS) was increased 1.5-fold and the percentage of multiply phosphorylated peptides increased from 17 to 24% with introduction of the 4-step elution method. Phosphopeptides were purified by the improved method from tryptic digests of cytosol fractions of Xenopus eggs without and with a Ca2+-stimulus, and then, analysed by MS. One thousand three hundred and seventy-five and 994 phosphopeptides were reproducibly detected on duplicate MS, respectively. They included 818 and 437 phosphopeptides specific to each digest, respectively. A method involving isobaric tags for relative and absolute quantitation (iTRAQ) was also applied to compare the phosphorylation levels in Xenopus eggs without and with a Ca2+-stimulus, the ratios for 112 phosphopeptides in tryptic digests of these egg cytosol fractions being obtained. It was suggested from all the results that the phosphorylation sites and levels change during Xenopus egg activation for many known and unknown sites on structural proteins, signalling related proteins, cell cycle-related proteins and others. PMID:26530081

  12. Solcoseryl, a tissue respiration stimulating agent, significantly enhances the effect of capacitively coupled electric field on the promotion of bone formation around dental implants.

    PubMed

    Ochi, Morio; Wang, Pao-Li; Ohura, Kiyoshi; Takashima, Shigenori; Kagami, Hiroyuki; Hirose, Yukito; Kaku, Tohru; Sakaguchi, Kunihiko

    2003-06-01

    In the present study we examined the combined effect of application of a capacitively coupled electric field (CCEF) and the tissue respiration stimulating agent, Solcoseryl, on the promotion of bone formation around dental implants histologically and mechanically. After a dental implant was inserted into each femur of Japanese white rabbits, Solcoseryl (2 ml/kg) was administered intravenously in the ear vein and a CCEF was applied for 4 h per day for 14 days. The degree of bone formation on microscopic observation, bone contact ratio, bone surface area ratio, and the level of removal torque of the implant in the Solcoseryl- and CCEF-treated group were significantly higher than the respective value in the control group, which had not been treated with Solcoseryl nor CCEF. Thus, the combination of CCEF stimulation and Solcoseryl effectively promoted the formation of new bone. It is suggested that the clinical use of a combination of CCEF stimulation and Solcoseryl for dental implants promotes osseointegration.

  13. Effects of Pulse Shape and Polarity on Sensitivity to Cochlear Implant Stimulation: A Chronic Study in Guinea Pigs.

    PubMed

    Macherey, Olivier; Cazals, Yves

    2016-01-01

    Most cochlear implants (CIs) stimulate the auditory nerve with trains of symmetric biphasic pulses consisting of two phases of opposite polarity. Animal and human studies have shown that both polarities can elicit neural responses. In human CI listeners, studies have shown that at suprathreshold levels, the anodic phase is more effective than the cathodic phase. In contrast, animal studies usually show the opposite trend. Although the reason for this discrepancy remains unclear, computational modelling results have proposed that the degeneration of the peripheral processes of the neurons could lead to a higher efficiency of anodic stimulation. We tested this hypothesis in ten guinea pigs who were deafened with an injection of sysomycin and implanted with a single ball electrode inserted in the first turn of the cochlea. Animals were tested at regular intervals between 1 week after deafening and up to 1 year for some of them. Our hypothesis was that if the effect of polarity is determined by the presence or absence of peripheral processes, the difference in polarity efficiency should change over time because of a progressive neural degeneration. Stimuli consisted of charge-balanced symmetric and asymmetric pulses allowing us to observe the response to each polarity individually. For all stimuli, the inferior colliculus evoked potential was measured. Results show that the cathodic phase was more effective than the anodic phase and that this remained so even several months after deafening. This suggests that neural degeneration cannot entirely account for the higher efficiency of anodic stimulation observed in human CI listeners.

  14. Vagal nerve stimulation for refractory epilepsy: the surgical procedure and complications in 100 implantations by a single medical center.

    PubMed

    Horowitz, Gilad; Amit, Moran; Fried, Itzhak; Neufeld, Miri Y; Sharf, Liad; Kramer, Uri; Fliss, Dan M

    2013-01-01

    In 1997, the US Food and Drug Administration approved the use of intermittent stimulation of the left vagal nerve as adjunctive therapy for seizure control. Vagal nerve stimulation (VNS) has since been considered a safe and effective treatment for medically intractable seizures. The objective of this study is to present our experience with the surgical procedure and outcomes after VNS insertion in the first 100 consecutive patients treated at the Tel-Aviv "Sourasky" Medical Center (TASMC). All patients who underwent VNS device implantation by the authors at TASMC between 2005 and 2011 were studied. The collected data included age at onset of epilepsy, seizure type, duration of epilepsy, age at VNS device implantation, seizure reduction, surgical complications, and adverse effects of VNS over time. Fifty-three males and 47 females, age 21.2 ± 11.1 years, underwent VNS implantation. Indications for surgery were medically refractory epilepsy. The most common seizure type was focal (55 patients, 55 %). Seizure duration until implantation was 14.4 ± 9 years. Mean follow-up time after device insertion was 24.5 ± 22 months. Complications were encountered in 12 patients. The most common complication was local infection (6 patients, 6 %). Six devices were removed-four due to infection and two due to loss of clinical effect. Currently, 63 patients remain in active long-term follow-up; of these, 35 patients have >50 % reduction in frequency of attacks.VNS is a well-tolerated and effective therapeutic alternative in the management of medically refractory epilepsy. The surgical procedure is safe and has a low complication rate.

  15. Right ventricular stimulation threshold at ICD implant predicts device therapy in primary prevention patients with ischaemic heart disease.

    PubMed

    Atary, Jael Z; Borleffs, C Jan Willem; van der Bom, Johanna G; Trines, Serge A I P; Bootsma, Marianne; Zeppenfeld, Katja; van Erven, Lieselot; Schalij, Martin J

    2010-11-01

    Myocardial excitability is known (amongst other reasons) to be related to the degree of ischaemia, contractile dysfunction and heart failure. It was hypothesized that the right ventricular (RV) stimulation threshold has prognostic value with respect to the occurrence of ventricular arrhythmias (VAs) and patient survival in recipients of an implantable cardioverter defibrillator (ICD). Ischaemic heart disease patients receiving an ICD at Leiden University Medical Center as primary prevention for sudden cardiac death were included in this study. Right ventricular thresholds were determined at ICD implant. Data were collected on VAs triggering ICD therapy and on all-cause mortality. A total of 689 consecutive patients were included (87% male, age 63 ± 11 years, left ventricular ejection fraction (LVEF) 29 ± 11%) and followed for a median of 28 months. Post-implant RV-threshold was 0.7 ± 0.5 volt (V) at 0.5 ms pulse duration. Best dichotomous separation was reached at a cut-off of 1 V. During follow-up, 167 (24%) patients received appropriate ICD therapy, 88 (13%) had appropriate shocks and 134 (19%) died. Cumulative appropriate shock incidence for patients with RV threshold ≥ 1 V (n = 166) was 16% at 1 year, 24% at 3 years and 34% at 5 years compared with 4, 11 and 17% for patients with an RV-threshold < 1 V (n = 523). Adjusted hazard ratio of RV threshold ≥ 1 V was 2.0 (95% CI: 1.4-2.9) for appropriate therapy, 3.3 (95% CI: 2.0-5.4) for appropriate shocks and 1.6 (95% CI: 1.1-2.5) for mortality. The RV stimulation threshold at ICD implant has a strong independent prognostic value for the occurrence of VAs triggering appropriate ICD therapy, appropriate shocks and mortality.

  16. Evaluation of focused multipolar stimulation for cochlear implants in long-term deafened cats

    NASA Astrophysics Data System (ADS)

    George, Shefin S.; Wise, Andrew K.; Fallon, James B.; Shepherd, Robert K.

    2015-06-01

    Objective. Focused multipolar (FMP) stimulation has been shown to produce restricted neural activation using intracochlear stimulation in animals with a normal population of spiral ganglion neurons (SGNs). However, in a clinical setting, the widespread loss of SGNs and peripheral fibres following deafness is expected to influence the effectiveness of FMP. Approach. We compared the efficacy of FMP stimulation to both monopolar (MP) and tripolar (TP) stimulation in long-term deafened cat cochleae (n = 8). Unlike our previous study, these cochleae contained <10% of the normal SGN population adjacent to the electrode array. We also evaluated the effect of electrode position on stimulation modes by using either modiolar facing or lateral wall facing half-band electrodes. The spread of neural activity across the inferior colliculus, a major nucleus within the central auditory pathway, was used as a measure of spatial selectivity. Main results. In cochleae with significant SGN degeneration, we observed that FMP and TP stimulation resulted in greater spatial selectivity than MP stimulation (p < 0.001). However, thresholds were significantly higher for FMP and TP stimulation compared to MP stimulation (p < 0.001). No difference between FMP and TP stimulation was found in any measures. The high threshold levels for FMP stimulation was significantly reduced without compromising spatial selectivity by varying the degree of current focusing (referred as ‘partial-FMP’ stimulation). Spatial selectivity of all stimulation modes was unaffected by the electrode position. Finally, spatial selectivity in long-term deafened cochleae was significantly less than that of cochleae with normal SGN population (George S S et al 2014 J. Neural Eng. 11 065003). Significance. The present results indicate that the greater spatial selectivity of FMP and TP stimulation over MP stimulation is maintained in cochleae with significant neural degeneration and is not adversely affected by electrode

  17. Brain stem responses evoked by stimulation of the mature cochlear nucleus with an auditory brain stem implant.

    PubMed

    O'Driscoll, Martin; El-Deredy, Wael; Ramsden, Richard T

    2011-01-01

    The Nucleus auditory brain stem implant (ABI) has been used in the hearing rehabilitation of totally deaf individuals for whom a cochlear implant is not an option such as in the case of neurofibromatosis type 2 (NF2). Intraoperative electrically evoked auditory brain stem responses (EABRs) are recorded to assist in the placement of the electrode array over the dorsal and ventral cochlear nuclei in the lateral recess of the IVth ventricle of the brain stem. This study had four objectives: (1) to characterize EABRs evoked by stimulation with an ABI in adolescents and adults with NF2, (2) to evaluate how the EABR morphology relates to auditory sensations elicited from stimulation by an ABI, (3) to establish whether there is evidence of morphology changes in the EABR with site of stimulation by the ABI, and (4) to investigate how the threshold of the EABR relates to behavioral threshold and comfortably loud sensations measured at initial device activation. Intraoperative EABRs were recorded from 34 subjects with ABIs: 19 male and 15 female, mean age 27 yrs (range 12 to 52 yrs). ABI stimulation was applied at seven different sites using either wide bipolar stimulation across the array or in subsections of the array from medial to lateral and inferior to superior. The EABRs were analyzed with respect to morphology, peak latency, and changes in these characteristics with the site of stimulation. In a subset of eight subjects, additional narrow bipolar sites were stimulated to compare the intraoperative EABR threshold levels with the behavioral threshold (T) and comfortably loud (C) levels of stimulation required at initial device activation. EABRs were elicited from 91% of subjects. Morphology varied from one to four vertex-positive peaks with mean latencies of 0.76, 1.53, 2.51, and 3.64 msecs, respectively. The presence of an EABR from stimulation by electrodes across the whole array had a high predictive value for the presence of auditory electrodes at initial device

  18. Cathodic voltage-controlled electrical stimulation of titanium implants as treatment for methicillin-resistant Staphylococcus aureus periprosthetic infections.

    PubMed

    Ehrensberger, Mark T; Tobias, Menachem E; Nodzo, Scott R; Hansen, Lisa A; Luke-Marshall, Nicole R; Cole, Ross F; Wild, Linda M; Campagnari, Anthony A

    2015-02-01

    Effective treatment options are often limited for implant-associated orthopedic infections. In this study we evaluated the antimicrobial effects of applying cathodic voltage-controlled electrical stimulation (CVCES) of -1.8 V (vs. Ag/AgCl) to commercially pure titanium (cpTi) substrates with preformed biofilm-like structures of methicillin-resistant Staphylococcus aureus (MRSA). The in vitro studies showed that as compared to the open circuit potential (OCP) conditions, CVCES of -1.8 V for 1 h significantly reduced the colony-forming units (CFU) of MRSA enumerated from the cpTi by 97% (1.89 × 106 vs 6.45 × 104 CFU/ml) and from the surrounding solution by 92% (6.63 × 105 vs. 5.15 × 104 CFU/ml). The in vivo studies, utilizing a rodent periprosthetic infection model, showed that as compared to the OCP conditions, CVCES at -1.8 V for 1 h significantly reduced MRSA CFUs in the bone tissue by 87% (1.15 × 105 vs. 1.48 × 104 CFU/ml) and reduced CFU on the cpTi implant by 98% (5.48 × 104 vs 1.16 × 103 CFU/ml). The stimulation was not associated with histological changes in the host tissue surrounding the implant. As compared to the OCP conditions, the -1.8 V stimulation significantly increased the interfacial capacitance (18.93 vs. 98.25 μF/cm(2)) and decreased polarization resistance (868,250 vs. 108 Ω-cm(2)) of the cpTi. The antimicrobial effects are thought to be associated with these voltage-dependent electrochemical surface properties of the cpTi.

  19. Intracranial Injection of an Optogenetics Viral Vector Followed by Optical Cannula Implantation for Neural Stimulation in Rat Brain Cortex.

    PubMed

    Pawela, Christopher; DeYoe, Edgar; Pashaie, Ramin

    2016-01-01

    Optogenetics is rapidly gaining acceptance as a preferred method to study specific neuronal cell types using light. Optogenetic neuromodulation requires the introduction of a cell-specific viral vector encoding for a light activating ion channel or ion pump and the utilization of a system to deliver light stimulation to brain. Here, we describe a two-part methodology starting with a procedure to inject an optogenetic AAV virus into rat cortex followed by a second procedure to surgically implant an optical cannula for light delivery to the deeper cortical layers.

  20. Safe transcranial electric stimulation motor evoked potential monitoring during posterior spinal fusion in two patients with cochlear implants.

    PubMed

    Yellin, Joseph L; Wiggins, Cheryl R; Franco, Alier J; Sankar, Wudbhav N

    2016-08-01

    Transcranial electric stimulation (TES) motor evoked potentials (MEPs) have become a regular part of intraoperative neurophysiologic monitoring (IONM) for posterior spinal fusion (PSF) surgery. Almost all of the relative contraindications to TES have come and gone. One exception is in the case of patients with a cochlear implant (CI). Herein we illustrate two cases of pediatric patients with CIs who underwent PSF using TES MEPs as part of IONM. In both instances the patients displayed no untoward effects from TES, and post-operatively both CIs were intact and functioning as they were prior to surgery.

  1. Interference of programmed electromagnetic stimulation with pacemakers and automatic implantable cardioverter defibrillators.

    PubMed

    Gwechenberger, Marianne; Rauscha, Friedrich; Stix, Günter; Schmid, Gernot; Strametz-Juranek, Jeanette

    2006-07-01

    A commercially available magnetic therapy system, designed for clinical application as well as for private use without medical supervision, was examined with respect to its potential for causing electromagnetic interference with implantable pacemakers (PMs) and automatic implantable cardioverter defibrillators (AICDs). A sample of 15 PMs and 5 AICDs were experimentally investigated. Each of the implants was realistically positioned in a homogeneous, electrically passive torso phantom and exposed to the magnetic fields of the system's applicators (whole body mat, cushion, and bar applicator). The detection thresholds of the implants were programmed to maximum sensitivity and both unipolar as well as bipolar electrode configurations were considered. The evaluation of possible interferences was derived from the internal event storages and pacing statistics recorded by the implants during exposure. Any "heart activity" recorded by the implants during exposure was interpreted as a potential interference, because the implant obviously misinterpreted the external interference signal as a physiological signal. Only cases without any recorded "heart activity" and with nominal pacing rates (as expected from the program parameter settings) of the implants were rated as "interference-free." Exposure to the whole body mat (peak magnetic induction up to 265 microT) did not show an influence on PMs and AICD in any case. The cushion applicator at the highest field intensity (peak magnetic induction up to 360 microT) led to atrial sensing defects in four PM models with unipolar electrode configuration. Under bipolar electrode configuration no disturbances occurred. The bar applicator led to sensing problems and consecutively reduced pacing rates in all tested PM models under unipolar electrode configuration and maximum field intensity (peak magnetic induction up to 980 microT). Bipolar electrode configuration resolved the problem. The investigated AICDs did not show malfunctions

  2. The Prediction of Speech Recognition in Noise With a Semi-Implantable Bone Conduction Hearing System by External Bone Conduction Stimulation With Headband

    PubMed Central

    Ihler, Friedrich; Blum, Jenny; Berger, Max-Ulrich; Weiss, Bernhard G.; Welz, Christian

    2016-01-01

    Semi-implantable transcutaneous bone conduction devices are treatment options for conductive and mixed hearing loss (CHL/MHL). For counseling of patients, realistic simulation of the functional result is desirable. This study compared speech recognition in noise with a semi-implantable transcutaneous bone conduction device to external stimulation with a bone conduction device fixed by a headband. Eight German-language adult patients were enrolled after a semi-implantable transcutaneous bone conduction device (Bonebridge, Med-El) was implanted and fitted. Patients received a bone conduction device for external stimulation (Baha BP110, Cochlear) fixed by a headband for comparison. The main outcome measure was speech recognition in noise (Oldenburg Sentence Test). Pure-tone audiometry was performed and subjective benefit was assessed using the Glasgow Benefit Inventory and Abbreviated Profile of Hearing Aid Benefit questionnaires. Unaided, patients showed a mean signal-to-noise ratio threshold of 4.6 ± 4.2 dB S/N for speech recognition. The aided results were −3.3 ± 7.2 dB S/N by external bone conduction stimulation and −1.2 ± 4.0 dB S/N by the semi-implantable bone conduction device. The difference between the two devices was not statistically significant, while the difference was significant between unaided and aided situation for both devices. Both questionnaires for subjective benefit favored the semi-implantable device over external stimulation. We conclude that it is possible to simulate the result of speech recognition in noise with a semi-implantable transcutaneous bone conduction device by external stimulation. This should be part of preoperative counseling of patients with CHL/MHL before implantation of a bone conduction device. PMID:27698259

  3. The Prediction of Speech Recognition in Noise With a Semi-Implantable Bone Conduction Hearing System by External Bone Conduction Stimulation With Headband: A Prospective Study.

    PubMed

    Ihler, Friedrich; Blum, Jenny; Berger, Max-Ulrich; Weiss, Bernhard G; Welz, Christian; Canis, Martin

    2016-10-03

    Semi-implantable transcutaneous bone conduction devices are treatment options for conductive and mixed hearing loss (CHL/MHL). For counseling of patients, realistic simulation of the functional result is desirable. This study compared speech recognition in noise with a semi-implantable transcutaneous bone conduction device to external stimulation with a bone conduction device fixed by a headband. Eight German-language adult patients were enrolled after a semi-implantable transcutaneous bone conduction device (Bonebridge, Med-El) was implanted and fitted. Patients received a bone conduction device for external stimulation (Baha BP110, Cochlear) fixed by a headband for comparison. The main outcome measure was speech recognition in noise (Oldenburg Sentence Test). Pure-tone audiometry was performed and subjective benefit was assessed using the Glasgow Benefit Inventory and Abbreviated Profile of Hearing Aid Benefit questionnaires. Unaided, patients showed a mean signal-to-noise ratio threshold of 4.6 ± 4.2 dB S/N for speech recognition. The aided results were -3.3 ± 7.2 dB S/N by external bone conduction stimulation and -1.2 ± 4.0 dB S/N by the semi-implantable bone conduction device. The difference between the two devices was not statistically significant, while the difference was significant between unaided and aided situation for both devices. Both questionnaires for subjective benefit favored the semi-implantable device over external stimulation. We conclude that it is possible to simulate the result of speech recognition in noise with a semi-implantable transcutaneous bone conduction device by external stimulation. This should be part of preoperative counseling of patients with CHL/MHL before implantation of a bone conduction device.

  4. Strategy towards independent electrical stimulation from cochlear implants: Guided auditory neuron growth on topographically modified nanocrystalline diamond.

    PubMed

    Cai, Yixiao; Edin, Fredrik; Jin, Zhe; Alexsson, Andrei; Gudjonsson, Olafur; Liu, Wei; Rask-Andersen, Helge; Karlsson, Mikael; Li, Hao

    2016-02-01

    Cochlear implants (CI) have been used for several decades to treat patients with profound hearing loss. Nevertheless, results vary between individuals, and fine hearing is generally poor due to the lack of discrete neural stimulation from the individual receptor hair cells. A major problem is the deliverance of independent stimulation signals to individual auditory neurons. Fine hearing requires significantly more stimulation contacts with intimate neuron/electrode interphases from ordered axonal re-growth, something current CI technology cannot provide. Here, we demonstrate the potential application of micro-textured nanocrystalline diamond (NCD) surfaces on CI electrode arrays. Such textured NCD surfaces consist of micrometer-sized nail-head-shaped pillars (size 5×5μm(2)) made with sequences of micro/nano-fabrication processes, including sputtering, photolithography and plasma etching. The results show that human and murine inner-ear ganglion neurites and, potentially, neural progenitor cells can attach to patterned NCD surfaces without an extracellular matrix coating. Microscopic methods revealed adhesion and neural growth, specifically along the nail-head-shaped NCD pillars in an ordered manner, rather than in non-textured areas. This pattern was established when the inter-NCD pillar distance varied between 4 and 9μm. The findings demonstrate that regenerating auditory neurons show a strong affinity to the NCD pillars, and the technique could be used for neural guidance and the creation of new neural networks. Together with the NCD's unique anti-bacterial and electrical properties, patterned NCD surfaces could provide designed neural/electrode interfaces to create independent electrical stimulation signals in CI electrode arrays for the neural population. Cochlear implant is currently a successful way to treat sensorineural hearing loss and deafness especially in children. Although clinically successful, patients' fine hearing cannot be completely restored

  5. Mesenchymal stromal cell implantation for stimulation of long bone healing aggravates Staphylococcus aureus induced osteomyelitis.

    PubMed

    Seebach, Elisabeth; Holschbach, Jeannine; Buchta, Nicole; Bitsch, Rudi Georg; Kleinschmidt, Kerstin; Richter, Wiltrud

    2015-07-01

    Large bone defects requiring long-term osteosynthetic stabilization or repeated surgeries show a considerable rate of infection. Mesenchymal stromal cells (MSCs) have been successfully used to enhance bone regeneration, but their powerful immunomodulatory effects may impose an enhanced risk for osteomyelitis development. In order to unravel whether implantation of MSCs aggravates a simultaneous bone infection, a hydrogel-supported osteomyelitis ostectomy model was developed in which rats received a femoral bone defect with rigid plate-fixation. After fibrin-assisted transfer of Staphylococcus aureus (SA), effects of MSC implantation on osteomyelitis development were quantified over 3-4 weeks. All SA-infected animals developed an acute local osteomyelitis with significantly increased blood neutrophil count, abscess formation and bone destruction. MSC-treatment of infected defects aggravated osteomyelitis according to a significantly elevated osteomyelitis score and enhanced distal bone loss with spongy alteration of cortical bone architecture. Increased attraction of macrophages, osteoclasts and regulation of pro- and anti-inflammatory mediators were potential MSC actions. Overall trophic actions of MSCs implanted into non-sterile bone defects may enhance an infection and/or exacerbate osteomyelitis. Studies on antibiotic carrier augmentation or antibiotic treatment are warranted to decide whether MSC implantation is a safe and promising therapy for orthopedic implant-stabilized bone defects at high risk for development of infection.

  6. Wireless data and power transfer of an optogenetic implantable visual cortex stimulator.

    PubMed

    Fattah, Nabeel; Laha, Soumyasanta; Sokolov, Danil; Chester, Graeme; Degenaar, Patrick

    2015-08-01

    In this paper, the wireless data and power transfer for a novel optogenetic visual cortex implant system was demonstrated by using pork tissue mimic in-vitro at the ISM 2.4 GHz and 13.5 MHz frequency band respectively. The observed data rate was 120 kbps with no loss in data for up to a thickness of 35 mm in both water & pork. To increase the power level of the implant a Class E power amplifier is separately designed and simulated for the transmitter end and has an output power of around 223 mW with an efficiency of 81.83%. The transferred power at the receiver was measured to be 66.80 mW for the pork tissue medium considering a distance of 5 mm between the transmitter and the receiver coils, with a coupling coefficient of ~0.8. This serves the power requirement of the visual cortex implant.

  7. In Situ Characterization of Stimulating Microelectrode Arrays: Study of an Idealized Structure Based on Argus II Retinal implants

    NASA Astrophysics Data System (ADS)

    Kandagor, Vincent; Cela, Carlos J.; Sanders, Charlene A.; Greenbaum, Elias; Lazzi, Gianluca; Zhou, David D.; Castro, Richard; Gaikwad, Sanjay; Little, Jim

    The development of a retinal prosthesis for artificial sight includes a study of the factors affecting the structural and functional stability of chronically implanted microelectrode arrays. Although neuron depolarization and propagation of electrical signals have been studied for nearly a century, the use of multielectrode stimulation as a proposed therapy to treat blindness is a frontier area of modern ophthalmology research. Mapping and characterizing the topographic information contained in the electric field potentials and understanding how this information is transmitted and interpreted in the visual cortex is still very much a work in progress. In order to characterize the electrical field patterns generated by the device, an in vitro prototype that mimics several of the physical and chemical parameters of the in vivo visual implant device was fabricated. We carried out multiple electrical measurements in a model "eye," beginning with a single electrode, followed by a 9-electrode array structure, both idealized components based on the Argus II retinal implants. Correlating the information contained in the topographic features of the electric fields with psychophysical testing in patients may help reduce the time required for patients to convert the electrical patterns into graphic signals.

  8. Preoperative parameters and their prognostic value in amyotrophic lateral sclerosis patients undergoing implantation of a diaphragm pacing stimulation system

    PubMed Central

    Şanlı, Aydın; Şengün, Ihsan Şükrü; Karaçam, Volkan; Alpaydın, Aylin Özgen; Tertemiz, Kemal Can; Özalevli, Sevgi; Şanlı, Bahar Ağaoğlu; Kaya, Alper; Özdemir, Nezih

    2017-01-01

    Introduction: Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular disease with devastating and fatal respiratory complications. Diaphragm pacing stimulation (DPS) is a treatment option in diaphragm insufficient ALS patients. Ventilatory insufficiency depending on diaphragmatic failure is treated by the present study aimed to investigate prognostic value of preoperative clinical and functional characteristics of ALS patients undergoing implantation of a DPS system and to determine appropriate indications for the DPS system. Methods: The study included 34 ALS patients implanted with DPS system. All patients underwent multidisciplinary and laboratory evaluations before the surgery. The laboratory examinations included pulmonary function tests and arterial blood gas analysis. Survival rates were recorded in a 2-year follow-up after the surgery. Results: Twenty-eight of 34 patients with ALS survived after a 2-year follow-up. These patients were younger than those who died and had the disease for a longer time; however, the differences were not significant. Both right and left hemidiaghragms were thicker in the survived patients (P < 0.0001 for each). Pulmonary function tests revealed no significant differences between the patients who survived. Arterial blood gas analysis demonstrated lower partial pressure of carbon dioxide in the survived patients (P = 0.025). Conclusions: DPS implantation was more efficacious in ALS patients with mild respiratory failure and thicker diaphragm. Predictors of long-term effectiveness of DPS system are needed to be addressed by large-scale studies. PMID:28298842

  9. Masking patterns for monopolar and phantom electrode stimulation in cochlear implants

    PubMed Central

    Saoji, Aniket A.; Landsberger, David M.; Padilla, Monica; Litvak, Leonid M.

    2013-01-01

    Phantom electrode (PE) stimulation consists of out-of-phase stimulation of two electrodes. When presented at the apex of the electrode array, phantom stimulation is known to produce a lower pitch sensation than monopolar (MP) stimulation on the most apical electrode. The ratio of the current between the primary electrode (PEL) and the compensating electrode (CEL) is represented by the coefficient σ, which ranges from 0 (monopolar) to 1 (full bipolar). The exact mechanism by which PE stimulation produces a lower pitch sensation is unclear. In the present study, unmasked and masked thresholds were obtained using a forward masking paradigm to estimate the spread of current for MP and PE stimulation. Masked thresholds were measured for two phantom electrode configurations (1) PEL = 4, CEL = 5 (lower pitch phantom) and (2) PEL = 4, CEL = 3 (higher pitch phantom). The unmasked thresholds were subtracted from the masked thresholds to obtain masking patterns which were normalized to their peak. The masking patterns reveal (1) differences in the spread of excitation that are consistent with the direction of pitch shift produced by PE stimulation, and (2) narrower spread of electrical excitation for PE stimulation relative to MP stimulation. PMID:23299125

  10. Rate discrimination at low pulse rates in normal-hearing and cochlear implant listeners: Influence of intracochlear stimulation site.

    PubMed

    Stahl, Pierre; Macherey, Olivier; Meunier, Sabine; Roman, Stéphane

    2016-04-01

    Temporal pitch perception in cochlear implantees remains weaker than in normal hearing listeners and is usually limited to rates below about 300 pulses per second (pps). Recent studies have suggested that stimulating the apical part of the cochlea may improve the temporal coding of pitch by cochlear implants (CIs), compared to stimulating other sites. The present study focuses on rate discrimination at low pulse rates (ranging from 20 to 104 pps). Two experiments measured and compared pulse rate difference limens (DLs) at four fundamental frequencies (ranging from 20 to 104 Hz) in both CI and normal-hearing (NH) listeners. Experiment 1 measured DLs in users of the (Med-El CI, Innsbruck, Austria) device for two electrodes (one apical and one basal). In experiment 2, DLs for NH listeners were compared for unresolved harmonic complex tones filtered in two frequency regions (lower cut-off frequencies of 1200 and 3600 Hz, respectively) and for different bandwidths. Pulse rate discrimination performance was significantly better when stimulation was provided by the apical electrode in CI users and by the lower-frequency tone complexes in NH listeners. This set of data appears consistent with better temporal coding when stimulation originates from apical regions of the cochlea.

  11. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage.

    PubMed

    Maldonado, Igor Lima; Roujeau, Thomas; Cif, Laura; Gonzalez, Victoria; El-Fertit, Hassan; Vasques, Xavier; Bonafe, Alain; Coubes, Phillippe

    2009-12-01

    The aim of this study was to determine the safety of a deep brain stimulation technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of patients undergoing operation for movement disorders. One hundred ninety-four patients treated with deep brain stimulation between 1996 and 2007 were assessed via a computerized database for intra- and perioperative events. Most patients were young; only 62 of them were older than 40 years (mean age, 31.1 years). General anesthesia was induced in all cases before placement of a magnetic resonance imaging-compatible stereotactic frame. Electrode implantation was done under radioscopic control via a rigid immobile cannula using a single cerebral perforation. No perioperative microelectrode recording or neurostimulation testing was used. Systematic postoperative magnetic resonance imaging was performed before frame removal. A total of 478 electrodes were implanted in 220 procedures: 426 for dystonic-dyskinetic syndromes and 52 for Parkinson disease. The mean number of parenchymal penetrations per patient was 2.5 for the dystonic-dyskinetic syndrome group and 2.08 for the Parkinson disease group. Postimplantation magnetic resonance imaging detected no perioperative intraparenchymal hemorrhages. We consider that the risk of hemorrhagic complication is multifactorial but closely related to the chosen technique.

  12. Effect of stimulation rate on cochlear implant users' phoneme, word and sentence recognition in quiet and in noise.

    PubMed

    Shannon, Robert V; Cruz, Rachel J; Galvin, John J

    2011-01-01

    High stimulation rates in cochlear implants (CI) offer better temporal sampling, can induce stochastic-like firing of auditory neurons and can increase the electric dynamic range, all of which could improve CI speech performance. While commercial CI have employed increasingly high stimulation rates, no clear or consistent advantage has been shown for high rates. In this study, speech recognition was acutely measured with experimental processors in 7 CI subjects (Clarion CII users). The stimulation rate varied between (approx.) 600 and 4800 pulses per second per electrode (ppse) and the number of active electrodes varied between 4 and 16. Vowel, consonant, consonant-nucleus-consonant word and IEEE sentence recognition was acutely measured in quiet and in steady noise (+10 dB signal-to-noise ratio). Subjective quality ratings were obtained for each of the experimental processors in quiet and in noise. Except for a small difference for vowel recognition in quiet, there were no significant differences in performance among the experimental stimulation rates for any of the speech measures. There was also a small but significant increase in subjective quality rating as stimulation rates increased from 1200 to 2400 ppse in noise. Consistent with previous studies, performance significantly improved as the number of electrodes was increased from 4 to 8, but no significant difference showed between 8, 12 and 16 electrodes. Altogether, there was little-to-no advantage of high stimulation rates in quiet or in noise, at least for the present speech tests and conditions. Copyright © 2010 S. Karger AG, Basel.

  13. Implanted Electrical Stimulation of the Trunk for Seated Postural Stability and Function after Cervical SCI: A Single Case Study

    PubMed Central

    Triolo, Ronald J.; Boggs, Lisa; Miller, Michael E.; Nemunaitis, Gregory; Nagy, Jennifer; Bailey, Stephanie Nogan

    2008-01-01

    Objective(s) To explore and quantify the physical and functional effects of stabilizing the torso with electrical stimulation of the paralyzed hip and trunk musculature after motor complete tetraplegia. Design Single-subject case study with repeated measures and concurrent controls. Setting Academic outpatient rehabilitation center. Participants Forty-four year old male with C4 ASIA A tetraplegia 20 years post spinal cord injury. Intervention A surgically implanted multichannel pulse generator and intramuscular stimulating electrodes to activate lumbar erector spinae, quadratus lumborum, and gluteus maximus muscles bilaterally. Main Outcome Measure(s) Outcomes assessed with and without stimulation included a) spinal alignment and pelvic orientation, b) pulmonary function and ventilatory volumes, c) forward bimanual reaching distance, d) seated stability and resistance to externally applied disturbances, e) maximal force and speed of rowing-like movements, and the ability to f) independently return to an erect seated position from full forward or lateral flexion, and g) roll in bed without assistance. Results Stimulation improved spinal convexity and kyphosis by 26° and 21°, reduced posterior pelvic tilt by 11°; increased forced expiratory volume and vital capacity by 10% and 22%, and improved forward reach by > 7 cm. Average resistance to sagittal disturbances increased by > 40% (p<0.002) and mean force exerted during underhanded pulling more than doubled (p=0.014) with stimulation. Restoration of upright sitting in both sagittal and coronal planes and bed turning were made possible through appropriately timed activation of the hip and trunk muscles. Conclusions A neuroprosthesis for controlling the paralyzed torso can positively impact spinal alignment, seated posture, pulmonary function, trunk stability, and reach. Stimulation of hip and trunk muscles can improve performance of activities of daily living as well as enable independent wheelchair and bed

  14. ASIC or PIC? Implantable stimulators based on semi-custom CMOS technology or low-power microcontroller architecture.

    PubMed

    Salmons, S; Gunning, G T; Taylor, I; Grainger, S R; Hitchings, D J; Blackhurst, J; Jarvis, J C

    2001-01-01

    To gain a better understanding of the effects of chronic stimulation on mammalian muscles we needed to generate patterns of greater variety and complexity than simple constant-frequency or burst patterns. We describe here two approaches to the design of implantable neuromuscular stimulators that can satisfy these requirements. Devices of both types were developed and used in long-term experiments. The first device was based on a semi-custom Application Specific Integrated Circuit (ASIC). This approach has the advantage that the circuit can be completely tested at every stage of development and production, assuring a high degree of reliability. It has the drawback of inflexibility: the patterns are produced by state machines implemented in silicon, so each new set of patterns requires a fresh production run, which is costly and time-consuming. The second device was based on a commercial microcontroller (Microchip PIC16C84). The functionality of this type of circuit is specified in software rather than in silicon hardware, allowing a single device to be programmed for different functions. With the use of features designed to improve fault-tolerance we found this approach to be as reliable as that based on ASICs. The encapsulated devices can easily be accommodated subcutaneously on the flank of a rabbit and a recent version is small enough to implant into the peritoneal cavity of rats. The current devices are programmed with a predetermined set of 12 patterns before assembly; the desired pattern is selected after implantation with an electronic flash gun. The operating current drain is less than 40 microA.

  15. Collagen type I coating stimulates bone regeneration and osteointegration of titanium implants in the osteopenic rat.

    PubMed

    Sartori, Maria; Giavaresi, Gianluca; Parrilli, Annapaola; Ferrari, Andrea; Aldini, Nicolò Nicoli; Morra, Marco; Cassinelli, Clara; Bollati, Daniele; Fini, Milena

    2015-10-01

    To investigate the effects of titanium implants functionalised with collagen type I (TiColl) on bone regeneration and osteointegration in a healthy and osteopenic rat animal model. TiColl screws were implanted into the femoral condyles of healthy and osteopenic rats and compared with acid-etched titanium (Ti) screws. The osteointegration process was evaluated by a complementary approach combining microtomographic, histological, histomorphometric and biomechanical investigations at four and 12 weeks. The TiColl screw also ensured a greater mechanical stability; the push-out values for TiColl screws increased from four to 12 weeks (+28 %). The energy necessary to detach the bone from the screw was significantly higher for TiColl-functionalised screws in comparison to Ti screws (+23 %) at 12 weeks. Histomorphometric investigation revealed that total bone-to-implant contact was higher in TiColl screws in comparison to Ti screws (P < 0.05) and at epiphyseal level, increased bone-to-implant contact was found with TiColl screws in comparison to Ti screws (P < 0.05) in an ovariectomy (OVX) condition. A significant increase in the measured total bone ingrowth from four to 12 weeks was detected for both materials, but more significant for the TiColl material (P < 0.0005). Finally, bone ingrowth in the TiColl group was significantly higher (P < 0.005) in comparison to that of Ti screws in the SHAM condition at metaphyseal level at 12 weeks. The present results showed that TiColl is effective in promoting implant osteointegration even in compromised bone.

  16. Dual electrode stimulation using the nucleus CI24RE cochlear implant: electrode impedance and pitch ranking studies.

    PubMed

    Busby, Peter A; Plant, Kerrie L

    2005-10-01

    The first aim of the study was to determine the reduction in electrode impedances using dual electrode stimulation compared with single electrode stimulation in the new Nucleus CI24RE receiver-stimulator. The CI24RE is connected to the Nucleus 22-electrode intracochlear array. Dual electrode stimulation is produced by electrically coupling two adjacent single electrodes. The second aim was to determine whether dual electrode stimulation produced pitch percepts that were intermediate to the pitch of the two adjacent single electrodes. Eight postlingually hearing-impaired adults with severe to profound loss, implanted with the CI24RE, participated in the study. Electrode impedances were measured by using the standard telemetry function of the system. A pitch ranking task was used to measure pitch for dual and single electrodes. Seven sets of three electrodes along the electrode array were tested. Each set of electrodes consisted of a dual electrode and the two adjacent single electrodes. Pitch ranking was measured using a two-alternative forced choice procedure, with the three electrodes in each set paired with each other as AB and BA pairs. The subject indicated which of the two stimuli had the higher pitch. Random variation in current level was used to remove any loudness cues. The average electrode impedance was 38.6% lower for dual electrodes compared with single electrodes. Three subjects were able to successfully rank the three electrodes in each set in the expected tonotopic order for all seven sets of electrodes along the array. Three other subjects were able to rank sets of electrodes in the tonotopic order for most of the tested positions on the array. The remaining two subjects gave more variable pitch ranking across positions along the array, although successful tonotopic ranking was demonstrated for several sets of electrodes. Dual electrode stimulation with the CI24RE receiver-stimulator produced systematically lower electrode impedances and was capable

  17. Presacral abscess as a rare complication of sacral nerve stimulator implantation.

    PubMed

    Gumber, A; Ayyar, S; Varia, H; Pettit, S

    2017-03-01

    A 50-year-old man with intractable anal pain attributed to proctalgia fugax underwent insertion of a sacral nerve stimulator via the right S3 vertebral foramen for pain control with good symptomatic relief. Thirteen months later, he presented with signs of sepsis. Computed tomography (CT) and magnetic resonance imaging (MRI) showed a large presacral abscess. MRI demonstrated increased enhancement along the pathway of the stimulator electrode, indicating that the abscess was caused by infection introduced at the time of sacral nerve stimulator placement. The patient was treated with broad spectrum antibiotics, and the sacral nerve stimulator and electrode were removed. Attempts were made to drain the abscess transrectally using minimally invasive techniques but these were unsuccessful and CT guided transperineal drainage was then performed. Despite this, the presacral abscess progressed, developing enlarging gas locules and extending to the pelvic brim to involve the aortic bifurcation, causing hydronephrosis and radiological signs of impending sacral osteomyelitis. MRI showed communication between the rectum and abscess resulting from transrectal drainage. In view of the progressive presacral sepsis, a laparotomy was performed with drainage of the abscess, closure of the upper rectum and formation of a defunctioning end sigmoid colostomy. Following this, the presacral infection resolved. Presacral abscess formation secondary to an infected sacral nerve stimulator electrode has not been reported previously. Our experience suggests that in a similar situation, the optimal management is to perform laparotomy with drainage of the presacral abscess together with simultaneous removal of the sacral nerve stimulator and electrode.

  18. Cortical activation in profoundly deaf patients during cochlear implant stimulation demonstrated by H sub 2 (15)O PET

    SciTech Connect

    Herzog, H.; Lamprecht, A.; Kuehn, A.R.; Roden, W.; Vosteen, K.H.; Feinendegen, L.E. )

    1991-05-01

    Cochlear implants (CIs) are used to provide sensations of sound to profoundly deaf patients. The performance of the CI is assessed mainly by the subjective reports of patients. The aim of this study was to look for objective cortical responses to the stimulation of the CI. Two postlingually and two prelingually deaf patients were investigated by positron emission tomography (PET) using {sup 15}O-labeled water (H{sub 2}{sup 15}O) to determine the regional cerebral blood flow (rCBF). Instead of quantifying rCBF in absolute terms, it was estimated by referring the regional tissue concentration of H{sub 2}{sup 15}O to the mean whole brain concentration. CI stimulation encoded from white noise and sequential words led to an increased rCBF in the primary and secondary (Wernicke) auditory cortex. Relative elevations of up to 33% were observed bilaterally, although they were higher contralateral to the CI. These results were obtained not only in the postlingually deaf patients but also in two patients who had never been able to hear. Thus, it could be demonstrated that PET measurements of cerebral H{sub 2}{sup 15}O distribution yield objective responses of the central auditory system during electrical stimulation by CIs in profoundly deaf patients.

  19. Neuronal loss due to prolonged controlled-current stimulation with chronically implanted microelectrodes in the cat cerebral cortex

    NASA Astrophysics Data System (ADS)

    McCreery, Douglas; Pikov, Victor; Troyk, Philip R.

    2010-06-01

    Activated iridium microelectrodes were implanted for 450-1282 days in the sensorimotor cortex of seven adult domestic cats and then pulsed for 240 h (8 h per day for 30 days) at 50 Hz. Continuous stimulation at 2 nC/phase and with a geometric charge density of 100 µC cm-2 produced no detectable change in neuronal density in the tissue surrounding the microelectrode tips. However, pulsing with a continuous 100% duty cycle at 4 nC/phase and with a geometric charge density of 200 µC cm-2 induced loss of cortical neurons over a radius of at least 150 µm from the electrode tips. The same stimulus regimen but with a duty cycle of 50% (1 s of stimulation, and then 1 s without stimulation repeated for 8 h) produced neuronal loss within a smaller radius, approximately 60 µm from the center of the electrode tips. However, there also was significant loss of neurons surrounding the unpulsed electrodes, presumably as a result of mechanical injury due to their insertion into and long-term residence in the tissue, and this was responsible for most of the neuronal loss within 150 µm of the electrodes pulsed with the 50% duty cycle.

  20. A Programmable Implantable Microstimulator SoC With Wireless Telemetry: Application in Closed-Loop Endocardial Stimulation for Cardiac Pacemaker.

    PubMed

    Shuenn-Yuh Lee; Su, M Y; Ming-Chun Liang; You-Yin Chen; Cheng-Han Hsieh; Chung-Min Yang; Hsin-Yi Lai; Jou-Wei Lin; Qiang Fang

    2011-12-01

    A low-power, wireless, and implantable microstimulator system on chip with smart powering management, immediate neural signal acquisition, and wireless rechargeable system is proposed. A system controller with parity checking handles the adjustable stimulus parameters for the stimulated objective. In the current paper, the rat's intra-cardiac electrogram is employed as the stimulated model in the animal study, and it is sensed by a low-voltage and low-power monitoring analog front end. The power management unit, which includes a rectifier, battery charging and detection, and a regulator, is used for the power control of the internal circuits. The stimulation data and required clock are extracted by a phase-locked-loop-based phase shift keying demodulator from an inductive AC signal. The full chip, which consumes 48 μW only, is fabricated in a TSMC 0.35 μm 2P4M standard CMOS process to perform the monitoring and pacing functions with inductively powered communication in the in vivo study.

  1. [Speech perception with electric-acoustic stimulation : Comparison with bilateral cochlear implant users in different noise conditions].

    PubMed

    Rader, T

    2015-02-01

    Cochlear implantation with the aim of hearing preservation for combined electric-acoustic stimulation (EAS) is the therapy of choice for patients with residual low-frequency hearing. Preserved residual acoustic hearing has a positive effect on speech intelligibility in difficult noise conditions. The goal of this study was to assess speech reception thresholds in various complex noise conditions for patients with EAS in comparison with patients using bilateral cochlear implants (CI). Speech perception in noise was measured for bilateral CI and EAS patient groups. A total of 22 listeners with normal hearing served as a control group. Speech reception thresholds (SRT) were measured using a closed-set sentence matrix test. Speech was presented with a single source in frontal position; noise was presented in frontal position or in a multisource noise field (MSNF) consisting of a four-loudspeaker array with independent noise sources. Modulated speech-simulating noise and pseudocontinuous noise served respectively as interference signal with different temporal characteristics. The average SRTs in the EAS group were significantly better in all test conditions than those of the group with bilateral CI. Both user groups showed significant improvement in the MSNF condition compared with the frontal noise condition as a result of bilateral interaction. The normal-hearing control group was able to use short temporal gaps in modulated noise to improve speech perception in noise (gap listening). This effect was absent in both implanted user groups. Patients with combined EAS in one ear and a hearing aid in the contralateral ear show significantly improved speech perception in complex noise conditions compared with bilateral CI recipients.

  2. Comparison of two methods for selecting minimum stimulation levels used in programming the Nucleus 22 cochlear implant.

    PubMed

    Skinner, M W; Holden, L K; Holden, T A; Demorest, M E

    1999-08-01

    Minimum stimulation levels for active electrodes in a Nucleus 22 cochlear implant were set at threshold (clinical default value) and raised levels (M = +2.04 dB) to determine if raised levels would improve recipients' understanding of soft speech sounds with the SPEAK speech coding strategy. Eight postlinguistically deaf adults participated in a 4-phase A1B1A2B2 test design. Speech recognition was evaluated with consonant-vowel nucleus-consonant (CNC) words in quiet and sentences in noise, both presented at 50, 60, and 70 dB SPL during 2 weekly sessions at the end of each phase. Group mean scores were significantly higher with the raised level program for words and phonemes at 50 and 60 dB SPL and for sentences at 50 and 70 dB SPL. All participants chose to use the raised level program in everyday life at the end of the study. The results suggest that clinical use of a raised level program for Nucleus 22 recipients has the potential to make soft sounds louder and, therefore, more salient in everyday life. Further research is needed to determine if this approach is appropriate for other cochlear implant devices.

  3. The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation.

    PubMed

    Petraglia, Frank W; Farber, S Harrison; Gramer, Robert; Verla, Terence; Wang, Frances; Thomas, Steven; Parente, Beth; Lad, Shivanand P

    2016-01-01

    Spinal cord stimulation (SCS) has been proven effective for multiple chronic pain syndromes. Over the past 40 years of use, the complication rates of SCS have been well defined in the literature; however, the incidence of one of the most devastating complications, spinal cord injury (SCI), remains largely unknown. The goal of the study was to quantify the incidence of SCI in both percutaneous and paddle electrode implantation. We conducted a retrospective review of the Thomson Reuter's MarketScan database of all patients that underwent percutaneous or paddle SCS implantation from 2000 to 2009. The main outcome measures of the study were the incidence of SCI and spinal hematoma within 30 days following operation. Overall 8326 patients met inclusion criteria for the study (percutaneous: 5458 vs. paddle: 2868). The overall incidence of SCI was 177 (2.13%) (percutaneous: 128 (2.35%) vs. paddle: 49 (1.71%), p = 0.0556). The overall incidence of spinal hematoma was 59 (0.71%) (percutaneous: 41 (0.75%) vs. paddle: 18 (0.63%), p = 0.5230). Our study shows that the overall incidence of SCI in SCS is low (2.13%), supporting that SCS is a safe procedure. No significant difference was found in the rates of SCI or spinal hematoma between the percutaneous and paddle groups. Further studies are needed to characterize the mechanisms of SCI in SCS and long-term outcomes in these patients. © 2015 International Neuromodulation Society.

  4. Stimulation from Cochlear Implant Electrodes Assists with Recovery from Asymmetric Perceptual Tilt: Evidence from the Subjective Visual Vertical Test

    PubMed Central

    Gnanasegaram, Joshua J.; Parkes, William J.; Cushing, Sharon L.; McKnight, Carmen L.; Papsin, Blake C.; Gordon, Karen A.

    2016-01-01

    Vestibular end organ impairment is highly prevalent in children who have sensorineural hearing loss (SNHL) rehabilitated with cochlear implants (CIs). As a result, spatial perception is likely to be impacted in this population. Of particular interest is the perception of visual vertical because it reflects a perceptual tilt in the roll axis and is sensitive to an imbalance in otolith function. The objectives of the present study were thus to identify abnormalities in perception of the vertical plane in children with SNHL and determine whether such abnormalities could be resolved with stimulation from the CI. Participants included 53 children (15.2 ± 4.0 years of age) with SNHL and vestibular loss, confirmed with vestibular evoked myogenic potential (VEMP) testing. Testing protocol was validated in a sample of nine young adults with normal hearing (28.8 ± 7.7 years). Perception of visual vertical was assessed using the static Subjective Visual Vertical (SVV) test performed with and without stimulation in the participants with cochleovestibular loss. Trains of electrical pulses were delivered by an electrode in the left and/or right ear. Asymmetric spatial orientation deficits were found in nearly half of the participants with CIs (24/53 [45%]). The abnormal perception in this cohort was exacerbated by visual tilts in the direction of their deficit. Electric pulse trains delivered using the CI shifted this abnormal perception towards center (i.e., normal; p = 0.007). Importantly, this benefit was realized regardless of which ear was stimulated. These results suggest a role for CI stimulation beyond the auditory system, in particular, for improving vestibular/balance function. PMID:27679562

  5. Treatment of GnRHa-implanted Senegalese sole (Solea senegalensis) with 11-ketoandrostenedione stimulates spermatogenesis and increases sperm motility.

    PubMed

    Agulleiro, Maria J; Scott, Alexander P; Duncan, Neil; Mylonas, Constantinos C; Cerdà, Joan

    2007-08-01

    The effect of 11-ketoandrostenedione (OA) on plasma concentrations of sexual steroids and spermatogenesis of Senegalese sole (Solea senegalensis) implanted with gonadotropin-releasing hormone agonist (GnRHa) was investigated. Males were treated with saline (control) or with GnRHa implants (50 mug kg(-1)) in the presence or absence of OA (2 or 7 mg kg(-1)) during twenty eight days. Treatment with GnRHa alone slightly stimulated spermatogenesis and milt production with respect to controls, and this was associated with a transient elevation of plasma 11-ketotestosterone (11-KT) at day seven and an increase of 5beta-reduced metabolite(s) of 17,20beta-dihydroxy-pregn-4-en-3-one (17,20betaP) at day twenty eight. However, treatment with GnRHa+OA increased plasma concentrations of 11-KT and free+sulphated 5beta-reduced metabolites of 17,20betaP at days seven, fourteen and twenty one. After twenty eight days, the testis of GnRHa+OA-treated fish showed a lower number of spermatogonia B and spermatocytes I, and a higher number of spermatids, than fish treated with GnRHa alone. In addition, the motility of spermatozoa produced by GnRHa+OA males was enhanced by 2-fold with respect to controls or GnRHa males. These results suggest that treatment of Senegalese sole with GnRHa+OA stimulates spermatogenesis resulting in more motile sperm. Such effects could be mediated by an increased synthesis of 11-KT and/or 17,20betaP in the testis but further studies will be required to elucidate the specific mechanism involved.

  6. An optically powered single-channel stimulation implant as test system for chronic biocompatibility and biostability of miniaturized retinal vision prostheses.

    PubMed

    Schanze, Thomas; Hesse, Lutz; Lau, Carsten; Greve, Nina; Haberer, Werner; Kammer, Sascha; Doerge, Thomas; Rentzos, Andreas; Stieglitz, Thomas

    2007-06-01

    A microsystem based microimplant with an optically powered single-channel stimulator was designed and developed as test system for an epi-retinal vision implant. Biostability of the hybrid assembly and the encapsulation materials were evaluated in pilot experiments in chronic implantations in a cat animal model. The implant was fabricated on a flexible polyimide substrate with integrated platinum electrode, interconnection lines, and contact pads for hybrid integration of electronic components. The receiver part was realized with four photodiodes connected in series. A parylene C coating was deposited on the electronic components as insulation layer. Silicone rubber was used to encapsulate the electronics in the shape of an artificial intraocular lens to allow proper implantation in the eye. Pilot experiments showed the biostability of the encapsulation approach and full electric functionality of the microimplant to generate stimulation currents over the implantation period of three months in two cats. In one cat, electrical stimulation of the retina evoked neuronal responses in the visual cortex and indicated the feasibility of the system approach for chronic use.

  7. Biochemical acclimation, stomatal limitation and precipitation patterns underlie decreases in photosynthetic stimulation of soybean (Glycine max) at elevated [CO₂] and temperatures under fully open air field conditions.

    PubMed

    Rosenthal, David M; Ruiz-Vera, Ursula M; Siebers, Matthew H; Gray, Sharon B; Bernacchi, Carl J; Ort, Donald R

    2014-09-01

    The net effect of elevated [CO2] and temperature on photosynthetic acclimation and plant productivity is poorly resolved. We assessed the effects of canopy warming and fully open air [CO2] enrichment on (1) the acclimation of two biochemical parameters that frequently limit photosynthesis (A), the maximum carboxylation capacity of Rubisco (Vc,max) and the maximum potential linear electron flux through photosystem II (Jmax), (2) the associated responses of leaf structural and chemical properties related to A, as well as (3) the stomatal limitation (l) imposed on A, for soybean over two growing seasons in a conventionally managed agricultural field in Illinois, USA. Acclimation to elevated [CO2] was consistent over two growing seasons with respect to Vc,max and Jmax. However, elevated temperature significantly decreased Jmax contributing to lower photosynthetic stimulation by elevated CO2. Large seasonal differences in precipitation altered soil moisture availability modulating the complex effects of elevated temperature and CO2 on biochemical and structural properties related to A. Elevated temperature also reduced the benefit of elevated [CO2] by eliminating decreases in stomatal limitation at elevated [CO2]. These results highlight the critical importance of considering multiple environmental factors (i.e. temperature, moisture, [CO2]) when trying to predict plant productivity in the context of climate change. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  8. Variation in Deep Brain Stimulation Electrode Impedance over Years Following Electrode Implantation

    PubMed Central

    Satzer, David; Lanctin, David; Eberly, Lynn E.; Abosch, Aviva

    2014-01-01

    Background Deep brain stimulation (DBS) electrode impedance is a major determinant of current delivery to target tissues, but long-term variation in impedance has received little attention. Objectives To assess the relationship between electrode impedance and time in a large DBS patient population and characterize the relationship between contact activity and impedance. Methods We collected retrospective impedance and programming data from 128 electrodes in 84 patients with Parkinson's disease, essential tremor, or dystonia. Effects of time, contact activity, stimulation voltage, and other parameters on impedance were assessed. We also examined impedance changes following contact activation and deactivation. Results Impedance decreased by 73 Ω/year (P < .001), with 72% of contacts following a downward trend. Impedance was on average 163 Ω lower in active contacts (P < .001). Contact activation and inactivation were associated with a more (P < .001) and less (P = .016) rapid decline in impedance, respectively. Higher stimulation voltages were associated with lower impedance values (P < .001). Contact number and electrode model were also significant predictors of impedance. Conclusions Impedance decreases gradually in a stimulation-dependent manner. These trends have implications for long-term programming, the development of a closed-loop DBS device, and current understanding of the electrode-tissue interface. PMID:24503709

  9. Practical considerations and nuances in anesthesia for patients undergoing deep brain stimulation implantation surgery

    PubMed Central

    Scharpf, Danielle Teresa; Sharma, Mayur; Rezai, Ali; Bergese, Sergio D.

    2015-01-01

    The field of functional neurosurgery has expanded in last decade to include newer indications, new devices, and new methods. This advancement has challenged anesthesia providers to adapt to these new requirements. This review aims to discuss the nuances and practical issues that are faced while administering anesthesia for deep brain stimulation surgery. PMID:26257844

  10. Implantation of stimulation electrodes in the subretinal space to demonstrate cortical responses in Yucatan minipig in the course of visual prosthesis development.

    PubMed

    Sachs, H G; Gekeler, F; Schwahn, H; Jakob, W; Köhler, M; Schulmeyer, F; Marienhagen, J; Brunner, U; Framme, C

    2005-01-01

    During the course of the development of visual prostheses, subretinal stimulation films were implanted in micropigs in order to prove the feasibility of subretinal electrical stimulation with subsequent cortical response. One aim was to demonstrate that epidural recording of visual evoked potentials is possible in the micropig. Film-bound stimulation electrode arrays were placed in the subretinal space of micropigs. This enabled the retina to be stimulated subretinally. Since conventional visual evoked potential (VEP) measuring is virtually impossible in the pig from the neurosurgical point of view, epidural recording electrode arrays were positioned over the visual cortex as permanent electrodes. The feasibility of temporary implantation of film-bound stimulation electrode arrays was successfully demonstrated in the micropig model. On stimulation with monopolar voltage pulses (1000 to 3000 mV), reproducible epidural VEP measurements (5 to 10 micronV) were detected. The feasibility of subretinal stimulation of the retina was demonstrated in a retinal model that is similar to the human retina. This animal model therefore offers a suitable means of studying the tolerability of stimulation situations in the course of visual prosthesis development.

  11. Evaluation of the Efficacy and Robustness of a Second Generation Implantable Stimulator in a Patient With Hemiplegia During 20 Years of Functional Electrical Stimulation of the Common Peroneal Nerve.

    PubMed

    Pečlin, Polona; Rozman, Janez; Krajnik, Janez; Ribarič, Samo

    2016-11-01

    We evaluated the efficacy and robustness of a second generation implantable stimulator for correcting drop foot (DF) in a patient with left-sided hemiplegia over 20 years of functional electrical stimulation (FES) of the common peroneal nerve (CPN). Dorsal flexion and eversion of the affected foot was partially restored by FES of the superficial region of the CPN innervating mostly the tibialis anterior (TA) and partly peroneus longus (PL) and peroneus brevis (PB) muscles. The reasons for implant failure during the long-term follow-up assessment were analyzed and resolving procedures were identified. The stimulator had an average failure rate of once every three years, due to repetitive mechanical load on the lead wires of its internal and/or external unit, and had to be serviced once per year to replace the heel switch integrated into the shoe sole. FES-associated mechanical trauma to the CPN elicited a thickening of the connective tissue around the CPN and a slightly compromised conduction velocity of the CPN. FES of the CPN, with the second generation implantable stimulator, improved gait parameters of the affected leg during the 20 years period. Long-term, daily FES enables a functional and reliable recruitment of nerve fibers, thus providing a sufficient dorsal flexion and optimal eversion of the affected foot to sustain unassisted, almost normal gait. Therefore, the presented implant is suitable for very long-term FES of the CPN. Copyright © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  12. [Simulation of speech perception with cochlear implants : Influence of frequency and level of fundamental frequency components with electronic acoustic stimulation].

    PubMed

    Rader, T; Fastl, H; Baumann, U

    2017-03-01

    After implantation of cochlear implants with hearing preservation for combined electronic acoustic stimulation (EAS), the residual acoustic hearing ability relays fundamental speech frequency information in the low frequency range. With the help of acoustic simulation of EAS hearing perception the impact of frequency and level fine structure of speech signals can be systematically examined. The aim of this study was to measure the speech reception threshold (SRT) under various noise conditions with acoustic EAS simulation by variation of the frequency and level information of the fundamental frequency f0 of speech. The study was carried out to determine to what extent the SRT is impaired by modification of the f0 fine structure. Using partial tone time pattern analysis an acoustic EAS simulation of the speech material from the Oldenburg sentence test (OLSA) was generated. In addition, determination of the f0 curve of the speech material was conducted. Subsequently, either the parameter frequency or level of f0 was fixed in order to remove one of the two fine contour information of the speech signal. The processed OLSA sentences were used to determine the SRT in background noise under various test conditions. The conditions "f0 fixed frequency" and "f0 fixed level" were tested under two different situations, under "amplitude modulated background noise" and "continuous background noise" conditions. A total of 24 subjects with normal hearing participated in the study. The SRT in background noise for the condition "f0 fixed frequency" was more favorable in continuous noise with 2.7 dB and in modulated noise with 0.8 dB compared to the condition "f0 fixed level" with 3.7 dB and 2.9 dB, respectively. In the simulation of speech perception with cochlear implants and acoustic components, the level information of the fundamental frequency had a stronger impact on speech intelligibility than the frequency information. The method of simulation of transmission of

  13. The effect of presentation level and stimulation rate on speech perception and modulation detection for cochlear implant users.

    PubMed

    Brochier, Tim; McDermott, Hugh J; McKay, Colette M

    2017-06-01

    In order to improve speech understanding for cochlear implant users, it is important to maximize the transmission of temporal information. The combined effects of stimulation rate and presentation level on temporal information transfer and speech understanding remain unclear. The present study systematically varied presentation level (60, 50, and 40 dBA) and stimulation rate [500 and 2400 pulses per second per electrode (pps)] in order to observe how the effect of rate on speech understanding changes for different presentation levels. Speech recognition in quiet and noise, and acoustic amplitude modulation detection thresholds (AMDTs) were measured with acoustic stimuli presented to speech processors via direct audio input (DAI). With the 500 pps processor, results showed significantly better performance for consonant-vowel nucleus-consonant words in quiet, and a reduced effect of noise on sentence recognition. However, no rate or level effect was found for AMDTs, perhaps partly because of amplitude compression in the sound processor. AMDTs were found to be strongly correlated with the effect of noise on sentence perception at low levels. These results indicate that AMDTs, at least when measured with the CP910 Freedom speech processor via DAI, explain between-subject variance of speech understanding, but do not explain within-subject variance for different rates and levels.

  14. Development of implantable optoelectronic module for optical brain tissue stimulation in freely moving mice

    NASA Astrophysics Data System (ADS)

    Rusakov, Konstantin; Czajkowski, Rafał; Kaźmierczak, Andrzej

    2015-09-01

    The research aims to design and manufacture of wireless optogenetics devices for freely moving animals in cages IntelliCage system. The purpose of the device is to stimulate specific brain regions using light. The constructed device consists of a light source and optical fibre structure responsible for delivering light into the corresponding region of the brain of the animal. The size of the animal (mouse) and the fact that it is freely moving imposes substantial limitations with respect to the size and weight of the optoelectronic device. The present paper describes research on optical fibre structure fabrication, assembling it to the small size (less than 500 × 500 μm2 top surface) LED chip and experimental validation of the optoelectronic stimulator.

  15. Development of an Implantable Pudendal Nerve Stimulator To Restore Bladder Function in Humans After SCI

    DTIC Science & Technology

    2016-10-01

    maximal current output. Electrical circuits of this design are attached with this report as Appendix 2. In addition to the...provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently ...Pudendal Nerve, Electrical Stimulation, Neuroprosthesis 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a. NAME OF

  16. Brain stem responses evoked by stimulation with an auditory brain stem implant in children with cochlear nerve aplasia or hypoplasia.

    PubMed

    O'Driscoll, Martin; El-Deredy, Wael; Atas, Ahmet; Sennaroglu, Gonca; Sennaroglu, Levent; Ramsden, Richard T

    2011-01-01

    The inclusion criteria for an auditory brain stem implant (ABI) have been extended beyond the traditional, postlingually deafened adult with Neurofibromatosis type 2, to include children who are born deaf due to cochlear nerve aplasia or hypoplasia and for whom a cochlear implant is not an option. Fitting the ABI for these new candidates presents a challenge, and intraoperative electrically evoked auditory brain stem responses (EABRs) may assist in the surgical placement of the electrode array over the dorsal and ventral cochlear nucleus in the brain stem and in the postoperative programming of the device. This study had four objectives: (1) to characterize the EABR by stimulation of the cochlear nucleus in children, (2) to establish whether there are any changes between the EABR recorded intraoperatively and again just before initial behavioral testing with the device, (3) to establish whether there is evidence of morphology changes in the EABR depending on the site of stimulation with the ABI, and (4) to investigate how the EABR relates to behavioral measurements and the presence of auditory and nonauditory sensations perceived with the ABI at initial device activation. Intra- and postoperative EABRs were recorded from six congenitally deaf children with ABIs, four boys and two girls, mean age 4.2 yrs (range 3.2 to 5.0 yrs). The ABI was stimulated at nine different bipolar sites on the array, and the EABRs recorded were analyzed with respect to the morphology and peak latency with site of stimulation for each recording session. The relationship between the EABR waveforms and the presence or absence of auditory electrodes at initial device activation was investigated. The EABR threshold levels were compared with the behavioral threshold (T) and comfortably loud (C) levels of stimulation required at initial device activation. EABRs were elicited from all children on both test occasions. Responses contained a possible combination of one to three peaks from a total

  17. Restoration of hearing by hearing aids: conventional hearing aids – implantable hearing aids – cochlear implants – auditory brainstem implants

    PubMed Central

    Leuwer, R.; Müller, J.

    2005-01-01

    Aim of this report is to explain the current concept of hearing restoration using hearing aids. At present the main issues of conventional hearing aids are the relative benefits of analogue versus digital devices and different strategies for the improvement of hearing in noise. Implantable hearing aids provide a better sound quality and less distortion. The lack of directional microphones is the major disadvantage of the partially implantable hearing aids commercially available. Two different clinical studies about fully implantable hearing aids have been started in 2004. One of the most-promising developments seems to be the electric-acoustic stimulation. PMID:22073051

  18. An in vivo investigation of first spike latencies in the inferior colliculus in response to multichannel penetrating auditory brainstem implant stimulation

    NASA Astrophysics Data System (ADS)

    Mauger, Stefan J.; Shivdasani, Mohit N.; Rathbone, Graeme D.; Argent, Rebecca E.; Paolini, Antonio G.

    2010-06-01

    The cochlear nucleus (CN) is the first auditory processing site within the brain and the target location of the auditory brainstem implant (ABI), which provides speech perception to patients who cannot benefit from a cochlear implant (CI). Although there is variance between ABI recipient speech performance outcomes, performance is typically low compared to CI recipients. Temporal aspects of neural firing such as first spike latency (FSL) are thought to code for many speech features; however, no studies have investigated FSL from CN stimulation. Consequently, ABIs currently do not incorporate CN-specific temporal information. We therefore systematically investigated inferior colliculus (IC) neuron's FSL response to frequency-specific electrical stimulation of the CN in rats. The range of FSLs from electrical stimulation of many neurons indicates that both monosynaptic and polysynaptic pathways were activated, suggesting initial activation of multiple CN neuron types. Electrical FSLs for a single neuron did not change irrespective of the CN frequency region stimulated, indicating highly segregated projections from the CN to the IC. These results present the first evidence of temporal responses to frequency-specific CN electrical stimulation. Understanding the auditory system's temporal response to electrical stimulation will help in future ABI designs and stimulation strategies.

  19. Restoration of ankle movements with the ActiGait implantable drop foot stimulator: a safe and reliable treatment option for permanent central leg palsy.

    PubMed

    Martin, Klaus Daniel; Polanski, Witold Henryk; Schulz, Anne-Kathrin; Jöbges, Michael; Hoff, Hansjoerg; Schackert, Gabriele; Pinzer, Thomas; Sobottka, Stephan B

    2016-01-01

    OBJECT The ActiGait drop foot stimulator is a promising technique for restoration of lost ankle function by an implantable hybrid stimulation system. It allows ankle dorsiflexion by active peroneal nerve stimulation during the swing phase of gait. In this paper the authors report the outcome of the first prospective study on a large number of patients with stroke-related drop foot. METHODS Twenty-seven patients who experienced a stroke and with persisting spastic leg paresis received an implantable ActiGait drop foot stimulator for restoration of ankle movement after successful surface test stimulation. After 3 to 5 weeks, the stimulator was activated, and gait speed, gait endurance, and activation time of the system were evaluated and compared with preoperative gait tests. In addition, patient satisfaction was assessed using a questionnaire. RESULTS Postoperative gait speed significantly improved from 33.9 seconds per 20 meters to 17.9 seconds per 20 meters (p < 0.0001), gait endurance from 196 meters in 6 minutes to 401 meters in 6 minutes (p < 0.0001), and activation time from 20.5 seconds to 10.6 seconds on average (p < 0.0001). In 2 patients with nerve injury, surgical repositioning of the electrode cuff became necessary. One patient showed a delayed wound healing, and in another patient the system had to be removed because of a wound infection. Marked improvement in mobility, social participation, and quality of life was confirmed by 89% to 96% of patients. CONCLUSIONS The ActiGait implantable drop foot stimulator improves gait speed, endurance, and quality of life in patients with stroke-related drop foot. Regarding gait speed, the ActiGait system appears to be advantageous compared with foot orthosis or surface stimulation devices. Randomized trials with more patients and longer observation periods are needed to prove the long-term benefit of this device.

  20. Me, Myself and My Brain Implant: Deep Brain Stimulation Raises Questions of Personal Authenticity and Alienation.

    PubMed

    Kraemer, Felicitas

    2013-01-01

    In this article, I explore select case studies of Parkinson patients treated with deep brain stimulation (DBS) in light of the notions of alienation and authenticity. While the literature on DBS has so far neglected the issues of authenticity and alienation, I argue that interpreting these cases in terms of these concepts raises new issues for not only the philosophical discussion of neuro-ethics of DBS, but also for the psychological and medical approach to patients under DBS. In particular, I suggest that the experience of alienation and authenticity varies from patient to patient with DBS. For some, alienation can be brought about by neurointerventions because patients no longer feel like themselves. But, on the other hand, it seems alienation can also be cured by DBS as other patients experience their state of mind as authentic under treatment and retrospectively regard their former lives without stimulation as alienated. I argue that we must do further research on the relevance of authenticity and alienation to patients treated with DBS in order to gain a deeper philosophical understanding, and to develop the best evaluative criterion for the behavior of DBS patients.

  1. Vagus nerve stimulator implantation for epilepsy in a paediatric hospital: outcomes and effect on quality of life.

    PubMed

    Ulate-Campos, A; Cean-Cabrera, L; Petanas-Argemi, J; García-Fructuoso, G; Aparicio, J; López-Sala, A; Palacio-Navarro, A; Mas, M J; Muchart, J; Rebollo, M; Sanmartí, F X

    2015-10-01

    Epilepsy, which is present in 0.5% to 1% of the paediatric population, is one of the most frequent childhood neurological disorders. Approximately 20% to 30% of these cases will be drug-resistant. The objective of this study is to describe the impact of vagal nerve stimulation (VNS) on seizures and quality of life in a sample of 30 patients. Descriptive, retrospective study of all patients with a VNS device implanted between 2008 and 2013 in a single paediatric hospital, based on patients' medical records. Quality of life was assessed using the Spanish scale for quality of life in children with epilepsy, completed by means of a telephone interview. We describe a population of 19 boys (64%) and 11 girls (36%) with a mean age at seizure onset of 21 months (1-144 months). The mean age of VNS implantation was 11.89 years. Follow-up periods ranged from 6 to 36 months. Mean reduction in seizures at 6 months was 38%, with a reduction of 43% at 12 months, 42% at 24 months, and 54% at 36 months. At least half of all patients were classified as responders. According to the quality of life scale, 54% of the families rated the effect of VNS as either very good or good while 39% rated it as fair. VNS is a safe palliative treatment that is generally well tolerated. It is partially effective for controlling drug-resistant epilepsy and exerts a positive effect on quality of life. Copyright © 2014 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

  2. Elastic and viscoelastic mechanical properties of brain tissues on the implanting trajectory of sub-thalamic nucleus stimulation.

    PubMed

    Li, Yan; Deng, Jianxin; Zhou, Jun; Li, Xueen

    2016-11-01

    Corresponding to pre-puncture and post-puncture insertion, elastic and viscoelastic mechanical properties of brain tissues on the implanting trajectory of sub-thalamic nucleus stimulation are investigated, respectively. Elastic mechanical properties in pre-puncture are investigated through pre-puncture needle insertion experiments using whole porcine brains. A linear polynomial and a second order polynomial are fitted to the average insertion force in pre-puncture. The Young's modulus in pre-puncture is calculated from the slope of the two fittings. Viscoelastic mechanical properties of brain tissues in post-puncture insertion are investigated through indentation stress relaxation tests for six interested regions along a planned trajectory. A linear viscoelastic model with a Prony series approximation is fitted to the average load trace of each region using Boltzmann hereditary integral. Shear relaxation moduli of each region are calculated using the parameters of the Prony series approximation. The results show that, in pre-puncture insertion, needle force almost increases linearly with needle displacement. Both fitting lines can perfectly fit the average insertion force. The Young's moduli calculated from the slope of the two fittings are worthy of trust to model linearly or nonlinearly instantaneous elastic responses of brain tissues, respectively. In post-puncture insertion, both region and time significantly affect the viscoelastic behaviors. Six tested regions can be classified into three categories in stiffness. Shear relaxation moduli decay dramatically in short time scales but equilibrium is never truly achieved. The regional and temporal viscoelastic mechanical properties in post-puncture insertion are valuable for guiding probe insertion into each region on the implanting trajectory.

  3. OptoZIF Drive: a 3D printed implant and assembly tool package for neural recording and optical stimulation in freely moving mice

    NASA Astrophysics Data System (ADS)

    Freedman, David S.; Schroeder, Joseph B.; Telian, Gregory I.; Zhang, Zhengyang; Sunil, Smrithi; Ritt, Jason T.

    2016-12-01

    Objective. Behavioral neuroscience studies in freely moving rodents require small, light-weight implants to facilitate neural recording and stimulation. Our goal was to develop an integrated package of 3D printed parts and assembly aids for labs to rapidly fabricate, with minimal training, an implant that combines individually positionable microelectrodes, an optical fiber, zero insertion force (ZIF-clip) headstage connection, and secondary recording electrodes, e.g. for electromyography (EMG). Approach. Starting from previous implant designs that position recording electrodes using a control screw, we developed an implant where the main drive body, protective shell, and non-metal components of the microdrives are 3D printed in parallel. We compared alternative shapes and orientations of circuit boards for electrode connection to the headstage, in terms of their size, weight, and ease of wire insertion. We iteratively refined assembly methods, and integrated additional assembly aids into the 3D printed casing. Main results. We demonstrate the effectiveness of the OptoZIF Drive by performing real time optogenetic feedback in behaving mice. A novel feature of the OptoZIF Drive is its vertical circuit board, which facilities direct ZIF-clip connection. This feature requires angled insertion of an optical fiber that still can exit the drive from the center of a ring of recording electrodes. We designed an innovative 2-part protective shell that can be installed during the implant surgery to facilitate making additional connections to the circuit board. We use this feature to show that facial EMG in mice can be used as a control signal to lock stimulation to the animal’s motion, with stable EMG signal over several months. To decrease assembly time, reduce assembly errors, and improve repeatability, we fabricate assembly aids including a drive holder, a drill guide, an implant fixture for microelectode ‘pinning’, and a gold plating fixture. Significance. The

  4. A New Implanted Posterior Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome: 3-Month Results of a Novel Therapy at a Single Center.

    PubMed

    van Breda, Hendrikje M K; Martens, Frank M J; Tromp, Johnny; Heesakkers, John P F A

    2017-07-01

    This study was designed to investigate the safety and performance of a new implantable system for tibial nerve stimulation for overactive bladder symptoms. A battery-free stimulation device for tibial nerve stimulation (BlueWind Medical, Herzliya, Israel) was implanted in 15 patients. Safety and efficacy assessments were done at 3 months after activation with a 3-day bladder diary, a 24-hour pad test and 2 quality of life questionnaires. Two males and 13 females were enrolled in the study. Mean age was 54 years (range 19 to 72). Five of 15 patients were previously treated with percutaneous tibial nerve stimulation and 12 experienced urgency urinary incontinence. Median operative time was 34 minutes. At 3 months of followup a significant change was seen in 24-hour frequency from a mean ± SD of 11.8 ± 3.5 to 8.1 ± 2.0 times per day (p = 0.002), the number of severe urinary urgency episodes from 6.5 ± 5.1 to 2.0 ± 2.1 times per day (p = 0.002), the number of severe incontinence episodes from 2.8 ± 5.2 to 0.3 ± 0.4 episodes per day (p = 0.017), urinary loss per day from 243 ± 388 to 39 ± 55 gm (p = 0.038) and improvement in quality of life. After implantation, 3 patients received prolonged antibiotic treatment and 3 received pain medication for 1 week. In 1 patient the device was explanted due to pain and swelling suspicious for infection, although tissue cultures did not reveal a bacterial infection. This novel posterior tibial nerve stimulator is safe and easy to implant with good clinical results. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  5. Understanding the effect of noise on electrical stimulation sequences in cochlear implants and its impact on speech intelligibility.

    PubMed

    Qazi, Obaid Ur Rehman; van Dijk, Bas; Moonen, Marc; Wouters, Jan

    2013-05-01

    The present study investigates the most important factors that limit the intelligibility of the cochlear implant (CI) processed speech in noisy environments. The electrical stimulation sequences provided in CIs are affected by the noise in the following three manners. First of all, the natural gaps in the speech are filled, which distorts the low-frequency ON/OFF modulations of the speech signal. Secondly, speech envelopes are distorted to include modulations of both speech and noise. Lastly, the N-of-M type of speech coding strategies may select the noise dominated channels instead of the dominant speech channels at low signal-to-noise ratio's (SNRs). Different stimulation sequences are tested with CI subjects to study how these three noise effects individually limit the intelligibility of the CI processed speech. Tests are also conducted with normal hearing (NH) subjects using vocoded speech to identify any significant differences in the noise reduction requirements and speech distortion limitations between the two subject groups. Results indicate that compared to NH subjects CI subjects can tolerate significantly lower levels of steady state speech shaped noise in the speech gaps but at the same time can tolerate comparable levels of distortions in the speech segments. Furthermore, modulations in the stimulus current level have no effect on speech intelligibility as long as the channel selection remains ideal. Finally, wrong maxima selection together with the introduction of noise in the speech gaps significantly degrades the intelligibility. At low SNRs wrong maxima selection introduces interruptions in the speech and makes it difficult to fuse noisy and interrupted speech signals into a coherent speech stream. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. Simulating the dual-peak excitation pattern produced by bipolar stimulation of a cochlear implant: effects on speech intelligibility.

    PubMed

    Mesnildrey, Quentin; Macherey, Olivier

    2015-01-01

    Several electrophysiological and psychophysical studies have shown that the spatial excitation pattern produced by bipolar stimulation of a cochlear implant (CI) can have a dual-peak shape. The perceptual effects of this dual-peak shape were investigated using noise-vocoded CI simulations in which synthesis filters were designed to simulate the spread of neural activity produced by various electrode configurations, as predicted by a simple cochlear model. Experiments 1 and 2 tested speech recognition in the presence of a concurrent speech masker for various sets of single-peak and dual-peak synthesis filters and different numbers of channels. Similarly as results obtained in real CIs, both monopolar (MP, single-peak) and bipolar (BP + 1, dual-peak) simulations showed a plateau of performance above 8 channels. The benefit of increasing the number of channels was also lower for BP + 1 than for MP. This shows that channel interactions in BP + 1 become especially deleterious for speech intelligibility when a simulated electrode acts both as an active and as a return electrode for different channels because envelope information from two different analysis bands are being conveyed to the same spectral location. Experiment 3 shows that these channel interactions are even stronger in wide BP configuration (BP + 5), likely because the interfering speech envelopes are less correlated than in narrow BP + 1. Although the exact effects of dual- or multi-peak excitation in real CIs remain to be determined, this series of experiments suggest that multipolar stimulation strategies, such as bipolar or tripolar, should be controlled to avoid neural excitation in the vicinity of the return electrodes. Copyright © 2014 Elsevier B.V. All rights reserved.

  7. [Bone Conduction and Active Middle Ear Implants].

    PubMed

    Volkenstein, S; Thomas, J P; Dazert, S

    2016-05-01

    The majority of patients with moderate to severe hearing loss can be supplied with conventional hearing aids depending on severity and cause for hearing loss in a satisfying way. However, some patients either do not benefit enough from conventional hearing aids or cannot wear them due to inflammatory reactions and chronic infections of the external auditory canal or due to anatomical reasons. For these patients there are fully- and semi-implantable middle ear and bone conduction implants available. These devices either directly stimulate the skull (bone conduction devices), middle ear structures (active middle ear implants) or the cochlea itself (direct acoustic stimulation). Patients who failed surgical hearing rehabilitation or do not benefit from conventional hearing aids may achieve a significant better speech understanding and tremendous improvement in quality of life by implantable hearing devices with careful attention to the audiological and anatomical indication criteria. © Georg Thieme Verlag KG Stuttgart · New York.

  8. Hepatocyte growth factor secreted by ovarian cancer cells stimulates peritoneal implantation via the mesothelial-mesenchymal transition of the peritoneum.

    PubMed

    Nakamura, Michihiko; Ono, Yoshihiro J; Kanemura, Masanori; Tanaka, Tomohito; Hayashi, Masami; Terai, Yoshito; Ohmichi, Masahide

    2015-11-01

    A current working model for the metastatic process of ovarian carcinoma suggests that cancer cells are shed from the ovarian tumor into the peritoneal cavity and attach to the layer of mesothelial cells that line the inner surface of the peritoneum, and several studies suggest that hepatocyte growth factor (HGF) plays an important role in the dissemination of ovarian cancer. Our objectives were to evaluate the HGF expression of ovarian cancer using clinical data and assess the effect of HGF secreted from human ovarian cancer cells to human mesothelial cells. HGF expression was immunohistochemically evaluated in 165 epithelial ovarian cancer patients arranged as tissue microarrays. HGF expression in four ovarian cancer cell lines was evaluated by using semi-quantitative polymerase chain reaction, Western blotting and enzyme-linked immunosorbent assay. The effect of ovarian cancer cell derived HGF to the human mesothelial cells was assessed by using morphologic analysis, Western blotting and cell invasion assay. The effect of HGF on ovarian cancer metastasis was assessed by using in vivo experimental model. The clinical data showed a significantly high correlation between the HGF expression and the cancer stage. The in vivo and in vitro experimental models revealed that HGF secreted by ovarian cancer cells induces the mesothelial-to-mesenchymal transition and stimulates the invasion of mesothelial cells. Furthermore, manipulating the HGF activity affected the degree of dissemination and ascite formation. We demonstrated that HGF secreted by ovarian cancer cells plays an important role in cancer peritoneal implantation. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator Implantation to Prevent Tachyarrhythmias following Acute Myocardial Infarction (PROTECT-ICD): Trial Protocol, Background and Significance.

    PubMed

    Zaman, Sarah; Taylor, Andrew J; Stiles, Martin; Chow, Clara; Kovoor, Pramesh

    2016-11-01

    The 'Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator Implantation to Prevent Tachyarrhythmias following Acute Myocardial Infarction' (PROTECT-ICD) trial is an Australian-led multicentre randomised controlled trial targeting prevention of sudden cardiac death in patients who have at least moderately reduced cardiac function following a myocardial infarct (MI). The primary objective of the trial is to assess whether electrophysiological study to guide prophylactic implantation of an implantable cardioverter-defibrillator (ICD) early following MI (first 40 days) will lead to a significant reduction in sudden cardiac death and non-fatal arrhythmia. The secondary objective is to assess the utility of cardiac MRI (CMR) in assessing early myocardial characteristics, and its predictive value for both inducible ventricular tachycardia (VT) at EPS and SCD/ non-fatal arrhythmia at follow-up.

  10. The incidence of seizures following Deep Brain Stimulating electrode implantation for movement disorders, pain and psychiatric conditions.

    PubMed

    Coley, E; Farhadi, R; Lewis, S; Whittle, I R

    2009-04-01

    Deep Brain Stimulation (DBS) for neuromodulation is now commonplace. However little is known about the incidence of either procedural related seizures or epilepsy following chronic DBS. This study aims to provide estimates of these complications for movement disorders, pain and psychiatric conditions. A literature review was performed. Because searches using the terms seizure, epilepsy, and deep brain stimulation revealed only papers dealing with experimental and clinical application of DBS to treat chronic seizures disorders, a search strategy trawling through papers that described clinical case series of DBS was used. Thirty-two papers were reviewed that described stereotactic placement of DBS electrodes for movement disorders, pain syndromes and psychiatric conditions with cohorts of n > 5. Sixteen of these papers describing at least 1418 DBS electrode placements in 1254 patients did not mention seizures as a complication (i.e., it was not possible to know whether seizures had or had not occurred). In 16 papers, describing at least 2101 electrode placements in 1555 patients, seizures were described in 42 patients (incidence 2.7%). The range of seizure incidence varied from 0% (three series encompassing 317 patients and 576 electrode placements) up to 10% (n = 130) and 13% (n = 15). The reasons for this variance were not obvious. At least 74% of seizures occurred around the time of electrode implantation and many of these patients also suffered intracranial hemorrhage. Follow up times were variable (range 6 mths to 5 years). The analysis was complicated by multiple publications from some centres with duplication of some data. The quality of literature on seizures following DBS insertion for neuromodulation is highly variable. Analysis of the available data, after making corrections for publication of duplicate data, suggests strongly that the risk of seizures associated with DBS placement is probably lower than 2.4% (95% CI 1.7 to 3.3 %). The risk of

  11. The Safety of Using Body-Transmit MRI in Patients with Implanted Deep Brain Stimulation Devices

    PubMed Central

    Kahan, Joshua; Papadaki, Anastasia; White, Mark; Mancini, Laura; Yousry, Tarek; Zrinzo, Ludvic; Limousin, Patricia; Hariz, Marwan; Foltynie, Tom; Thornton, John

    2015-01-01

    Background Deep brain stimulation (DBS) is an established treatment for patients with movement disorders. Patients receiving chronic DBS provide a unique opportunity to explore the underlying mechanisms of DBS using functional MRI. It has been shown that the main safety concern with MRI in these patients is heating at the electrode tips – which can be minimised with strict adherence to a supervised acquisition protocol using a head-transmit/receive coil at 1.5T. MRI using the body-transmit coil with a multi-channel receive head coil has a number of potential advantages including an improved signal-to-noise ratio. Study outline We compared the safety of cranial MRI in an in vitro model of bilateral DBS using both head-transmit and body-transmit coils. We performed fibre-optic thermometry at a Medtronic ActivaPC device and Medtronic 3389 electrodes during turbo-spin echo (TSE) MRI using both coil arrangements at 1.5T and 3T, in addition to gradient-echo echo-planar fMRI exposure at 1.5T. Finally, we investigated the effect of transmit-coil choice on DBS stimulus delivery during MRI. Results Temperature increases were consistently largest at the electrode tips. Changing from head- to body-transmit coil significantly increased the electrode temperature elevation during TSE scans with scanner-reported head SAR 0.2W/kg from 0.45°C to 0.79°C (p<0.001) at 1.5T, and from 1.25°C to 1.44°C (p<0.001) at 3T. The position of the phantom relative to the body coil significantly impacted on electrode heating at 1.5T; however, the greatest heating observed in any position tested remained <1°C at this field strength. Conclusions We conclude that (1) with our specific hardware and SAR-limited protocol, body-transmit cranial MRI at 1.5T does not produce heating exceeding international guidelines, even in cases of poorly positioned patients, (2) cranial MRI at 3T can readily produce heating exceeding international guidelines, (3) patients with ActivaPC Medtronic systems are safe

  12. The Safety of Using Body-Transmit MRI in Patients with Implanted Deep Brain Stimulation Devices.

    PubMed

    Kahan, Joshua; Papadaki, Anastasia; White, Mark; Mancini, Laura; Yousry, Tarek; Zrinzo, Ludvic; Limousin, Patricia; Hariz, Marwan; Foltynie, Tom; Thornton, John

    2015-01-01

    Deep brain stimulation (DBS) is an established treatment for patients with movement disorders. Patients receiving chronic DBS provide a unique opportunity to explore the underlying mechanisms of DBS using functional MRI. It has been shown that the main safety concern with MRI in these patients is heating at the electrode tips - which can be minimised with strict adherence to a supervised acquisition protocol using a head-transmit/receive coil at 1.5T. MRI using the body-transmit coil with a multi-channel receive head coil has a number of potential advantages including an improved signal-to-noise ratio. We compared the safety of cranial MRI in an in vitro model of bilateral DBS using both head-transmit and body-transmit coils. We performed fibre-optic thermometry at a Medtronic ActivaPC device and Medtronic 3389 electrodes during turbo-spin echo (TSE) MRI using both coil arrangements at 1.5T and 3T, in addition to gradient-echo echo-planar fMRI exposure at 1.5T. Finally, we investigated the effect of transmit-coil choice on DBS stimulus delivery during MRI. Temperature increases were consistently largest at the electrode tips. Changing from head- to body-transmit coil significantly increased the electrode temperature elevation during TSE scans with scanner-reported head SAR 0.2W/kg from 0.45°C to 0.79°C (p<0.001) at 1.5T, and from 1.25°C to 1.44°C (p<0.001) at 3T. The position of the phantom relative to the body coil significantly impacted on electrode heating at 1.5T; however, the greatest heating observed in any position tested remained <1°C at this field strength. We conclude that (1) with our specific hardware and SAR-limited protocol, body-transmit cranial MRI at 1.5T does not produce heating exceeding international guidelines, even in cases of poorly positioned patients, (2) cranial MRI at 3T can readily produce heating exceeding international guidelines, (3) patients with ActivaPC Medtronic systems are safe to be recruited to future fMRI experiments

  13. Estradiol-stimulated growth of MCF-7 tumors implanted in athymic mice: a model to study the tumoristatic action of tamoxifen.

    PubMed

    Gottardis, M M; Robinson, S P; Jordan, V C

    1988-01-01

    Ovariectomized athymic (nude) mice were inoculated (10(7) cells) with the breast cancer cell line, MCF-7, into the axillary mammary fat pads. Tumors did not grow unless animals were implanted with a 1.7 mg estradiol sustained (8-week)-release cholesterol pellet. Co-implantation with tamoxifen (5 mg, 4-week release) caused an inhibition of estradiol-stimulated growth but did not cause tumor growth when implanted alone. The metabolism of [3H]tamoxifen was determined in the athymic mouse bearing MCF-7 tumors. Metabolites in the liver, uterus and tumor were determined by TLC. The principal metabolite in each of the tissues was 4-hydroxytamoxifen (by comparison of Rfs with authentic standards). Studies with 4-hydroxytamoxifen and N-desmethyltamoxifen (the principal metabolites in patients) showed that each was effective in inhibiting estradiol-stimulated tumor growth. However, tumor growth could be reactivated by treatment with estradiol alone. In a separate experiment, tumor-implanted animals were treated with tamoxifen for 1, 2 and 6 months. Tamoxifen did not cause tumor growth. Nevertheless, tumor growth was reactivated by estradiol on each occasion. These studies confirm the tumoristatic actions of tamoxifen and strongly support the view that therapy must be given indefinitely to patients to control tumor recurrence. The athymic mouse model can be used in the future to determine the efficacy of novel antiestrogens and the development of antiestrogen drug resistance.

  14. Pain Control on Demand Based on Pulsed Radio-Frequency Stimulation of the Dorsal Root Ganglion Using a Batteryless Implantable CMOS SoC.

    PubMed

    Hung-Wei Chiu; Mu-Lien Lin; Chii-Wann Lin; I-Hsiu Ho; Wei-Tso Lin; Po-Hsiang Fang; Yi-Chin Lee; Yeong-Ray Wen; Shey-Shi Lu

    2010-12-01

    This paper presents the implementation of a batteryless CMOS SoC with low voltage pulsed radio-frequency (PRF) stimulation. This implantable SoC uses 402 MHz command signals following the medical implanted communication system (MICS) standard and a low frequency (1 MHz) for RF power transmission. A body floating type rectifier achieves 84% voltage conversion ratio. A bi-phasic pulse train of 1.4 V and 500 kHz is delivered by a PRF driver circuit. The PRF parameters include pulse duration, pulse frequency and repetition rate, which are controllable via 402 MHz RF receiver. The minimal required 3 V RF Vin and 2.2 V VDDr is achieved at 18 mm gap. The SoC chip is fabricated in a 0.35 μm CMOS process and mounted on a PCB with a flexible spiral antenna. The packaged PRF SoC was implanted into rats for the animal study. Von Frey was applied to test the mechanical allodynia in a blinded manner. This work has successfully demonstrated that implanted CMOS SoC stimulating DRG with 1.4 V, 500 kHz PRF could significantly reduce spinal nerve ligation (SNL) induced mechanical allodynia for 3-7 days.

  15. State of the Art: Novel Applications for Cortical Stimulation.

    PubMed

    De Ridder, Dirk; Perera, Sanjaya; Vanneste, Sven

    2017-04-01

    Electrical stimulation via implanted electrodes that overlie the cortex of the brain is an upcoming neurosurgical technique that was hindered for a long time by insufficient knowledge of how the brain functions in a dynamic, physiological, and pathological way, as well as by technological limitations of the implantable stimulation devices. This paper provides an overview of cortex stimulation via implantable devices and introduces future possibilities to improve cortex stimulation. Cortex stimulation was initially used preoperatively as a technique to localize functions in the brain and only later evolved into a treatment technique. It was first used for pain, but more recently a multitude of pathologies are being targeted by cortex stimulation. These disorders are being treated by stimulating different cortical areas of the brain. Risks and complications are essentially similar to those related to deep brain stimulation and predominantly include haemorrhage, seizures, infection, and hardware failures. For cortex stimulation to fully mature, further technological development is required to predict its outcomes and improve stimulation designs. This includes the development of network science-based functional connectivity approaches, genetic analyses, development of navigated high definition transcranial alternating current stimulation, and development of pseudorandom stimulation designs for preventing habituation. In conclusion, cortex stimulation is a nascent but very promising approach to treating a variety of diseases, but requires further technological development for predicting outcomes, such as network science based functional connectivity approaches, genetic analyses, development of navigated transcranial electrical stimulation, and development of pseudorandom stimulation designs for preventing habituation. © 2017 International Neuromodulation Society.

  16. Morphological Correlates of Hearing Loss after Cochlear Implantation and Electro-Acoustic Stimulation in a Hearing-Impaired Guinea Pig Model

    PubMed Central

    Reiss, Lina A.J.; Stark, Gemaine; Nguyen-Huynh, Anh T.; Spear, Kayce A.; Zhang, Hongzheng; Tanaka, Chiemi; Li, Hongzhe

    2016-01-01

    Hybrid or electro-acoustic stimulation (EAS) cochlear implants (CIs) are designed to provide high-frequency electric hearing together with residual low-frequency acoustic hearing. However, 30-50% of EAS CI recipients lose residual hearing after implantation. The objective of this study was to determine the mechanisms of EAS-induced hearing loss in an animal model with high-frequency hearing loss. Guinea pigs were exposed to 24 hours of noise (12-24 kHz at 116 dB) to induce a high-frequency hearing loss. After recovery, two groups of animals were implanted (n=6 per group), with one group receiving chronic acoustic and electric stimulation for 10 weeks, and the other group receiving no stimulation during this time frame. A third group (n=6) was not implanted, but received chronic acoustic stimulation. Auditory brainstem responses were recorded biweekly to monitor changes in hearing. The organ of Corti was immunolabeled with phalloidin, anti-CtBP2, and anti-GluR2 to quantify hair cells, ribbons and post-synaptic receptors. The lateral wall was immunolabeled with phalloidin and lectin to quantify stria vascularis capillary diameters. Bimodal or trimodal diameter distributions were observed; the number and location of peaks were objectively determined using the Aikake Information Criterion and Expectation Maximization algorithm. Noise exposure led to immediate hearing loss at 16-32 kHz for all groups. Cochlear implantation led to additional hearing loss at 4-8 kHz; this hearing loss was negatively and positively correlated with minimum and maximum peaks of the bimodal or trimodal distributions of stria vascularis capillary diameters, respectively. After chronic stimulation, no significant group changes in thresholds were seen; however, elevated thresholds at 1 kHz in implanted, stimulated animals were significantly correlated with decreased presynaptic ribbon and postsynaptic receptor counts. Inner and outer hair cell counts did not differ between groups and were not

  17. Morphological correlates of hearing loss after cochlear implantation and electro-acoustic stimulation in a hearing-impaired Guinea pig model.

    PubMed

    Reiss, Lina A J; Stark, Gemaine; Nguyen-Huynh, Anh T; Spear, Kayce A; Zhang, Hongzheng; Tanaka, Chiemi; Li, Hongzhe

    2015-09-01

    Hybrid or electro-acoustic stimulation (EAS) cochlear implants (CIs) are designed to provide high-frequency electric hearing together with residual low-frequency acoustic hearing. However, 30-50% of EAS CI recipients lose residual hearing after implantation. The objective of this study was to determine the mechanisms of EAS-induced hearing loss in an animal model with high-frequency hearing loss. Guinea pigs were exposed to 24 h of noise (12-24 kHz at 116 dB) to induce a high-frequency hearing loss. After recovery, two groups of animals were implanted (n = 6 per group), with one group receiving chronic acoustic and electric stimulation for 10 weeks, and the other group receiving no stimulation during this time frame. A third group (n = 6) was not implanted, but received chronic acoustic stimulation. Auditory brainstem responses were recorded biweekly to monitor changes in hearing. The organ of Corti was immunolabeled with phalloidin, anti-CtBP2, and anti-GluR2 to quantify hair cells, ribbons and post-synaptic receptors. The lateral wall was immunolabeled with phalloidin and lectin to quantify stria vascularis capillary diameters. Bimodal or trimodal diameter distributions were observed; the number and location of peaks were objectively determined using the Aikake Information Criterion and Expectation Maximization algorithm. Noise exposure led to immediate hearing loss at 16-32 kHz for all groups. Cochlear implantation led to additional hearing loss at 4-8 kHz; this hearing loss was negatively and positively correlated with minimum and maximum peaks of the bimodal or trimodal distributions of stria vascularis capillary diameters, respectively. After chronic stimulation, no significant group changes in thresholds were seen; however, elevated thresholds at 1 kHz in implanted, stimulated animals were significantly correlated with decreased presynaptic ribbon and postsynaptic receptor counts. Inner and outer hair cell counts did not differ between groups and

  18. Evaluation of Drug-Induced Sleep Endoscopy as a Patient Selection Tool for Implanted Upper Airway Stimulation for Obstructive Sleep Apnea

    PubMed Central

    Vanderveken, Olivier M.; Maurer, Joachim T.; Hohenhorst, Winfried; Hamans, Evert; Lin, Ho-Sheng; Vroegop, Anneclaire V.; Anders, Clemens; de Vries, Nico; Van de Heyning, Paul H.

    2013-01-01

    Study Objectives: To study the possible predictive value of drug-induced sleep endoscopy (DISE) in assessing therapeutic response to implanted upper airway stimulation (UAS) for obstructive sleep apnea (OSA). Methods: During DISE, artificial sleep is induced by midazolam and/or propofol, and the pharyngeal collapse patterns are visualized using a flexible fiberoptic nasopharyngoscope. The level (palate, oropharynx, tongue base, hypopharynx/epiglottis), the direction (anteroposterior, concentric, lateral), and the degree of collapse (none, partial, or complete) were scored in a standard fashion. Results: We report on the correlation between DISE results and therapy response in 21 OSA patients (apnea-hypopnea index [AHI] 38.5 ± 11.8/h; body mass index [BMI] 28 ± 2 kg/m2, age 55 ± 11 y, 20 male/1 female) who underwent DISE before implantation of a UAS system. Statistical analysis revealed a significantly better outcome with UAS in patients (n = 16) without palatal complete concentric collapse (CCC), reducing AHI from 37.6 ± 11.4/h at baseline to 11.1 ± 12.0/h with UAS (p < 0.001). No statistical difference was noted in AHI or BMI at baseline between the patients with and without palatal CCC. In addition, no predictive value was found for the other DISE collapse patterns documented. Conclusions: The absence of palatal CCC during DISE may predict therapeutic success with implanted UAS therapy. DISE can be recommended as a patient selection tool for implanted UAS to treat OSA. Citation: Vanderveken OM; Maurer JT; Hohenhorst W; Ha-mans E; Lin HS; Vroegop AV; Anders C; de Vries N; Van de Heyning PH. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. J Clin Sleep Med 2013;9(5):433-438. PMID:23674933

  19. Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort).

    PubMed

    Blackman, Daniel J; Meredith, Ian T; Dumonteil, Nicolas; Tchétché, Didier; Hildick-Smith, David; Spence, Mark S; Walters, Darren L; Harnek, Jan; Worthley, Stephen G; Rioufol, Gilles; Lefèvre, Thierry; Houle, Vicki M; Allocco, Dominic J; Dawkins, Keith D

    2017-07-15

    Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural predictors of mild or greater PVL at 30 days (or at discharge if 30-day data were not available) were determined using a multivariate regression model (n = 229). Of the 229 patients, 197 (86%) had no/trace PVL, 30 had mild, and 2 had moderate PVL; no patient had severe PVL. Significant predictors of mild/moderate PVL included device:annulus area ratio (odds ratio [OR] 0.87; 95% CI 0.83 to 0.92; p <0.001), left ventricular outflow tract calcium volume (OR 2.85; 95% CI 1.44 to 5.63; p = 0.003), and annulus area (OR 0.89; 95% CI 0.82 to 0.96; p = 0.002). When the device:annulus area ratio was <1, the rate of mild/moderate PVL was 53.1% (17 of 32). The rates of mild/moderate PVL with 0% to 5%, 5% to 10%, and >10% annular oversizing by area were 17.5% (11 of 63), 2.9% (2 of 70), and 3.2% (2 of 63), respectively. Significant independent predictors of PVL included device:annulus area ratio and left ventricular outflow tract calcium volume. When the prosthetic valve was oversized by ≥5%, the rate of mild or greater PVL was only 3%. In conclusion, the overall rates of PVL with the Lotus Valve are low and predominantly related to device/annulus areas and calcium; these findings have implications for optimal device sizing. Copyright

  20. Optimized speech understanding with the continuous interleaved sampling speech coding strategy in patients with cochlear implants: effect of variations in stimulation rate and number of channels.

    PubMed

    Kiefer, J; von Ilberg, C; Rupprecht, V; Hubner-Egner, J; Knecht, R

    2000-11-01

    The purpose of this study was to investigate the effect of systematic variations in stimulation rate and number of channels on speech understanding in 13 patients with cochlear implants who used the continuous interleaved sampling speech coding strategy. Reducing the stimulation rate from 1,515 to 1,730 pulses per second per channel to 600 pulses per second per channel resulted in decreased overall performance; the understanding of monosyllables and consonants was more affected than the understanding of vowels. Reducing the number of active channels below 7 or 8 channels decreased speech understanding; the identification of vowels and monosyllables was most affected. We conclude that vowel recognition with the continuous interleaved sampling strategy relies on spectral cues more than on temporal cues, increasing with the number of active channels, whereas consonant recognition is more dependent on temporal cues and stimulation rate.

  1. Biochemical acclimation, stomatal limitation and precipitation patterns underlie decreases in photosynthetic stimulation of Soybean (Glycine max) at elevated [CO2] and temperatures under fully open air field conditions

    USDA-ARS?s Scientific Manuscript database

    The net effect of elevated [CO2] and temperature on photosynthetic acclimation and plant productivity is poorly resolved. We assessed the effects of canopy warming and fully open air [CO2] enrichment on 1) the acclimation of two biochemical parameters that frequently limit photosynthesis (A), the ma...

  2. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea.

    PubMed

    Vanderveken, Olivier M; Maurer, Joachim T; Hohenhorst, Winfried; Hamans, Evert; Lin, Ho-Sheng; Vroegop, Anneclaire V; Anders, Clemens; de Vries, Nico; Van de Heyning, Paul H

    2013-05-15

    To study the possible predictive value of drug-induced sleep endoscopy (DISE) in assessing therapeutic response to implanted upper airway stimulation (UAS) for obstructive sleep apnea (OSA). During DISE, artificial sleep is induced by midazolam and/or propofol, and the pharyngeal collapse patterns are visualized using a flexible fiberoptic nasopharyngoscope. The level (palate, oropharynx, tongue base, hypopharynx/epiglottis), the direction (anteroposterior, concentric, lateral), and the degree of collapse (none, partial, or complete) were scored in a standard fashion. We report on the correlation between DISE results and therapy response in 21 OSA patients (apnea-hypopnea index [AHI] 38.5 ± 11.8/h; body mass index [BMI] 28 ± 2 kg/m(2), age 55 ± 11 y, 20 male/1 female) who underwent DISE before implantation of a UAS system. Statistical analysis revealed a significantly better outcome with UAS in patients (n = 16) without palatal complete concentric collapse (CCC), reducing AHI from 37.6 ± 11.4/h at baseline to 11.1 ± 12.0/h with UAS (p < 0.001). No statistical difference was noted in AHI or BMI at baseline between the patients with and without palatal CCC. In addition, no predictive value was found for the other DISE collapse patterns documented. The absence of palatal CCC during DISE may predict therapeutic success with implanted UAS therapy. DISE can be recommended as a patient selection tool for implanted UAS to treat OSA.

  3. Three-year follow-up of an implanted functional electrical stimulation system for upright mobility in a child with a thoracic level spinal cord injury.

    PubMed

    Betz, Randal R; Johnston, Therese E; Smith, Brian T; Mulcahey, M J; McCarthy, James J

    2002-01-01

    The purpose of this study was to compare the use of a functional electrical stimulation (FES) system with the use of knee-ankle-foot orthoses (KAFO) for upright mobility over a 3-year period in a child with a spinal cord injury (SCI). A 13-year-old boy with a T8 complete SCI received a lower extremity implanted FES system. Electrodes were implanted for knee extension and for hip extension, abduction, and adduction. After training and at annual intervals, independence and timeliness in completing 7 upright mobility activities with FES and KAFO, as well as stimulated muscle strength, were assessed. Results have shown that FES provided independence equal to that of KAFO for all activities. Four activities were accomplished more quickly with FES, including donning the system, reaching a high object, transferring to a high surface, and walking 6 m. A floor-to-stand transfer was faster with KAFO. Functional results and stimulated muscle strength have remained stable over the 3-year period. The results indicate that FES can provide function equal to or faster than KAFO in a child with a T8 complete SCI and that performance with the FES system can remain stable for at least 3 years.

  4. Vagus Nerve Stimulation

    MedlinePlus

    Vagus nerve stimulation Overview By Mayo Clinic Staff Vagus nerve stimulation is a procedure that involves implantation of a device that stimulates the vagus nerve with electrical impulses. There's one vagus nerve on ...

  5. Effects of Electrical Stimulation in the Inferior Colliculus on Frequency Discrimination by Rhesus Monkeys and Implications for the Auditory Midbrain Implant

    PubMed Central

    Ross, Deborah A.; Puñal, Vanessa M.; Agashe, Shruti; Dweck, Isaac; Mueller, Jerel; Grill, Warren M.; Wilson, Blake S.

    2016-01-01

    Understanding the relationship between the auditory selectivity of neurons and their contribution to perception is critical to the design of effective auditory brain prosthetics. These prosthetics seek to mimic natural activity patterns to achieve desired perceptual outcomes. We measured the contribution of inferior colliculus (IC) sites to perception using combined recording and electrical stimulation. Monkeys performed a frequency-based discrimination task, reporting whether a probe sound was higher or lower in frequency than a reference sound. Stimulation pulses were paired with the probe sound on 50% of trials (0.5–80 μA, 100–300 Hz, n = 172 IC locations in 3 rhesus monkeys). Electrical stimulation tended to bias the animals' judgments in a fashion that was coarsely but significantly correlated with the best frequency of the stimulation site compared with the reference frequency used in the task. Although there was considerable variability in the effects of stimulation (including impairments in performance and shifts in performance away from the direction predicted based on the site's response properties), the results indicate that stimulation of the IC can evoke percepts correlated with the frequency-tuning properties of the IC. Consistent with the implications of recent human studies, the main avenue for improvement for the auditory midbrain implant suggested by our findings is to increase the number and spatial extent of electrodes, to increase the size of the region that can be electrically activated, and to provide a greater range of evoked percepts. SIGNIFICANCE STATEMENT Patients with hearing loss stemming from causes that interrupt the auditory pathway after the cochlea need a brain prosthetic to restore hearing. Recently, prosthetic stimulation in the human inferior colliculus (IC) was evaluated in a clinical trial. Thus far, speech understanding was limited for the subjects and this limitation is thought to be partly due to challenges in

  6. Effects of Electrical Stimulation in the Inferior Colliculus on Frequency Discrimination by Rhesus Monkeys and Implications for the Auditory Midbrain Implant.

    PubMed

    Pages, Daniel S; Ross, Deborah A; Puñal, Vanessa M; Agashe, Shruti; Dweck, Isaac; Mueller, Jerel; Grill, Warren M; Wilson, Blake S; Groh, Jennifer M

    2016-05-04

    Understanding the relationship between the auditory selectivity of neurons and their contribution to perception is critical to the design of effective auditory brain prosthetics. These prosthetics seek to mimic natural activity patterns to achieve desired perceptual outcomes. We measured the contribution of inferior colliculus (IC) sites to perception using combined recording and electrical stimulation. Monkeys performed a frequency-based discrimination task, reporting whether a probe sound was higher or lower in frequency than a reference sound. Stimulation pulses were paired with the probe sound on 50% of trials (0.5-80 μA, 100-300 Hz, n = 172 IC locations in 3 rhesus monkeys). Electrical stimulation tended to bias the animals' judgments in a fashion that was coarsely but significantly correlated with the best frequency of the stimulation site compared with the reference frequency used in the task. Although there was considerable variability in the effects of stimulation (including impairments in performance and shifts in performance away from the direction predicted based on the site's response properties), the results indicate that stimulation of the IC can evoke percepts correlated with the frequency-tuning properties of the IC. Consistent with the implications of recent human studies, the main avenue for improvement for the auditory midbrain implant suggested by our findings is to increase the number and spatial extent of electrodes, to increase the size of the region that can be electrically activated, and to provide a greater range of evoked percepts. Patients with hearing loss stemming from causes that interrupt the auditory pathway after the cochlea need a brain prosthetic to restore hearing. Recently, prosthetic stimulation in the human inferior colliculus (IC) was evaluated in a clinical trial. Thus far, speech understanding was limited for the subjects and this limitation is thought to be partly due to challenges in harnessing the sound frequency

  7. Stimulation of implant fixation by parathyroid hormone (1-34)-A histomorphometric comparison of PMMA cement and stainless steel.

    PubMed

    Skripitz, Ralf; Böhling, Silvia; Rüther, Wolfgang; Aspenberg, Per

    2005-11-01

    Whereas continuous exposure to PTH results in bone resorption, PTH administration at intermittent doses results in bone formation by increasing osteoblast number and activity. PTH leads to faster fracture repair and better fixation of orthopaedic implants in animal models. The present study evaluates if PTH is able to increase the contact surface between bone and implant and whether the effect of PTH is dependent on implant material characteristics. The implants were made as rods, either of stainless steel or Palacos R bone-cement. The steel rods had a surface roughness of R(a) 0.1 microm and the cement rods R(a) 2.2 microm. In 40 adult male rats, one cement rod was inserted in the left tibia and one steel rod in the right tibia. After implantation, the rats were divided into groups by random. One group was injected three times a week with human PTH (1-34) at a dose of 60 microg/kg BW/injection. The second group was injected with the vehicle only. Both groups were then divided into groups for 2 and 4 weeks time till tibial harvest. The tibial segments around the hole of the rods were then prepared by standard histological techniques. The linear tissue surfaces, that had been in contact with the surface of the rod, were analyzed in a blind fashion. PTH increased the bone contact fraction compared with the vehicle in the steel group from 7.4 (SD 7.6) to 21.1 (SD 10.7) % after 2 weeks and from 9.8 (SD 8.1) to 47.1 (SD 13.3) % after 4 weeks. In the cement group PTH increased the contact index again compared with the vehicle from 7.8 (SD 10.2) to 53.6 (SD 26.3) % already after 2 weeks and from 14.3 (SD 15) to 65.6 (SD 15.7) % after 4 weeks. The bone trabeculae adjacent to the implant had become fewer and thicker after the treatment with PTH (1-34), with an increase of the bone mass in the area next to the bone-implant-interface. The earlier onset of PTH effects in the rougher cement group suggests that intermittent PTH treatment might lead to an increased micro

  8. Implantation of a new Vagus Nerve Stimulation (VNS) Therapy® generator, AspireSR®: considerations and recommendations during implantation and replacement surgery--comparison to a traditional system.

    PubMed

    Schneider, Ulf C; Bohlmann, Katrin; Vajkoczy, Peter; Straub, Hans-Beatus

    2015-04-01

    The most widely used neuro-stimulation treatment for drug-resistant epilepsy is Vagus Nerve Stimulation (VNS) Therapy®. Ictal tachycardia can be an indicator of a seizure and, if monitored, can be used to trigger an additional on-demand stimulation, which may positively influence seizure severity or duration. A new VNS Therapy generator model, AspireSR®, was introduced and approved for CE Mark in February 2014. In enhancement of former models, the AspireSR has incorporated a cardiac-based seizure-detection (CBSD) algorithm that can detect ictal tachycardia and automatically trigger a defined auto-stimulation. To evaluate differences in preoperative, intraoperative and postoperative handling, we compared the AspireSR to a conventional generator model (Demipulse®). Between February and September 2014, seven patients with drug-resistant epilepsy and ictal tachycardia were implanted with an AspireSR. Between November 2013 and September 2014, seven patients were implanted with a Demipulse and served as control group. Operation time, skin incision length and position, and complications were recorded. Handling of the new device was critically evaluated. The intraoperative handling was comparable and did not lead to a significant increase in operation time. In our 14 operations, we had no significant short-term complications. Due to its larger size, patients with the AspireSR had significantly larger skin incisions. For optimal heart rate detection, the AspireSR had to be placed significantly more medial in the décolleté area than the Demipulse. The preoperative testing is a unique addition to the implantation procedure of the AspireSR, which may provide minor difficulties, and for which we provide several recommendations and tips. The price of the device is higher than for all other models. The new AspireSR generator offers a unique technical improvement over the previous Demipulse. Whether the highly interesting CBSD feature will provide an additional benefit for

  9. Colony stimulating factor-1 receptor is a central component of the foreign body response to biomaterial implants in rodents and non-human primates

    NASA Astrophysics Data System (ADS)

    Doloff, Joshua C.; Veiseh, Omid; Vegas, Arturo J.; Tam, Hok Hei; Farah, Shady; Ma, Minglin; Li, Jie; Bader, Andrew; Chiu, Alan; Sadraei, Atieh; Aresta-Dasilva, Stephanie; Griffin, Marissa; Jhunjhunwala, Siddharth; Webber, Matthew; Siebert, Sean; Tang, Katherine; Chen, Michael; Langan, Erin; Dholokia, Nimit; Thakrar, Raj; Qi, Meirigeng; Oberholzer, Jose; Greiner, Dale L.; Langer, Robert; Anderson, Daniel G.

    2017-06-01

    Host recognition and immune-mediated foreign body response to biomaterials can compromise the performance of implanted medical devices. To identify key cell and cytokine targets, here we perform in-depth systems analysis of innate and adaptive immune system responses to implanted biomaterials in rodents and non-human primates. While macrophages are indispensable to the fibrotic cascade, surprisingly neutrophils and complement are not. Macrophages, via CXCL13, lead to downstream B cell recruitment, which further potentiated fibrosis, as confirmed by B cell knockout and CXCL13 neutralization. Interestingly, colony stimulating factor-1 receptor (CSF1R) is significantly increased following implantation of multiple biomaterial classes: ceramic, polymer and hydrogel. Its inhibition, like macrophage depletion, leads to complete loss of fibrosis, but spares other macrophage functions such as wound healing, reactive oxygen species production and phagocytosis. Our results indicate that targeting CSF1R may allow for a more selective method of fibrosis inhibition, and improve biomaterial biocompatibility without the need for broad immunosuppression.

  10. A simplified fixation of the new thin cochlear implant receiver-stimulators in children: long term results with the "back-pocket" technique.

    PubMed

    Cuda, Domenico

    2013-07-01

    To describe a simple technique for pediatric cochlear implant receiver-stimulators (R/S) fixation and long term results with it. Clinical sample include thirty-two children with severe-to-profound or profound hearing loss candidate for cochlear implantation. Low-profile devices were used (Med El Concerto and Nucleus CI512). The R/S was housed into a tight subperiosteal pocket carefully dissected behind the mastoidectomy. The pocket was closed with a single periosteal to bone suture around the posterior edge of mastoidectomy. No skull drilling was required for housing the device. No intraoperative complications have been observed. 20% of operating time was saved. No migration of R/S over time was apparent at follow up. The back-pocket technique seems effective in retaining the CI package and in optimizing surgical time and safety in pediatric cochlear implantation. It seems particularly suitable with new generation low profile CI devices. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  11. The multi-channel cochlear implant: multi-disciplinary development of electrical stimulation of the cochlea and the resulting clinical benefit.

    PubMed

    Clark, Graeme M

    2015-04-01

    This multi-disciplinary research showed sound could be coded by electrical stimulation of the cochlea and peripheral auditory nervous system. But the temporal coding of frequency as seen in the experimental animal, was inadequate for the important speech frequencies. The data indicated the limitation was due in particular to deterministic firing of neurons and failure to reproduce the normal fine temporo-spatial pattern of neural responses seen with sound. However, the data also showed the need for the place coding of frequency, and this meant multi-electrodes inserted into the cochlea. Nevertheless, before this was evaluated on people we undertook biological safety studies to determine the effects of surgical trauma and electrical stimuli, and how to prevent infection. Then our research demonstrated place of stimulation had timbre and was perceived as vowels. This led to our discovery in 1978 of the formant-extraction speech code that first enabled severely-profoundly deaf people to understand running speech. This result in people who had hearing before becoming severely deaf was an outcome not previously considered possible. In 1985 it was the first multi-channel implant to be approved by the US Food and Drug Administration (FDA). It was also the fore runner of our advanced formant and fixed filter strategies When these codes were used from 1985 for those born deaf or deafened early in life we discovered there was a critical period when brain plasticity would allow speech perception and language to be developed near- normally, and this required in particular the acquisition of place coding. In 1990 this led to the first cochlear implant to be approved by the FDA for use in children. Finally, we achieved binaural hearing in 1989 with bilateral cochlear implants, followed by bimodal speech processing in 1990 with a hearing aid in one ear and implant in the other. The above research has been developed industrially, with for example 250,000 people worldwide receiving

  12. PET Mapping for Brain-Computer Interface Stimulation of the Ventroposterior Medial Nucleus of the Thalamus in Rats with Implanted Electrodes.

    PubMed

    Zhu, Yunqi; Xu, Kedi; Xu, Caiyun; Zhang, Jiacheng; Ji, Jianfeng; Zheng, Xiaoxiang; Zhang, Hong; Tian, Mei

    2016-07-01

    Brain-computer interface (BCI) technology has great potential for improving the quality of life for neurologic patients. This study aimed to use PET mapping for BCI-based stimulation in a rat model with electrodes implanted in the ventroposterior medial (VPM) nucleus of the thalamus. PET imaging studies were conducted before and after stimulation of the right VPM. Stimulation induced significant orienting performance. (18)F-FDG uptake increased significantly in the paraventricular thalamic nucleus, septohippocampal nucleus, olfactory bulb, left crus II of the ansiform lobule of the cerebellum, and bilaterally in the lateral septum, amygdala, piriform cortex, endopiriform nucleus, and insular cortex, but it decreased in the right secondary visual cortex, right simple lobule of the cerebellum, and bilaterally in the somatosensory cortex. This study demonstrated that PET mapping after VPM stimulation can identify specific brain regions associated with orienting performance. PET molecular imaging may be an important approach for BCI-based research and its clinical applications. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

  13. Report of whole-brain radiation therapy in a patient with an implanted deep brain stimulator: important neurosurgical considerations and radiotherapy practice principles.

    PubMed

    Kotecha, Rupesh; Berriochoa, Camille A; Murphy, Erin S; Machado, Andre G; Chao, Samuel T; Suh, John H; Stephans, Kevin L

    2016-04-01

    Patients with implanted neuromodulation devices present potential challenges for radiation therapy treatment planning and delivery. Although guidelines exist regarding the irradiation of cardiac pacemakers and defibrillators, fewer data and less clinical experience exist regarding the effects of radiation therapy on less frequently used devices, such as deep brain stimulators. A 79-year-old woman with a history of coarse tremors effectively managed with deep brain stimulation presented with multiple intracranial metastases from a newly diagnosed lung cancer and was referred for whole-brain radiation therapy. She was treated with a German helmet technique to a total dose of 30 Gy in 10 fractions using 6 MV photons via opposed lateral fields with the neurostimulator turned off prior to delivery of each fraction. The patient tolerated the treatment well with no acute complications and no apparent change in the functionality of her neurostimulator device or effect on her underlying neuromuscular disorder. This represents the first reported case of the safe delivery of whole-brain radiation therapy in a patient with an implanted neurostimulator device. In cases such as this, neurosurgeons and radiation oncologists should have discussions with patients about the risks of brain injury, device malfunction or failure of the device, and plans for rigorous testing of the device before and after radiation therapy.

  14. Parameters of phosphene-inducing electric stimulation of the cat visual cortex via implanted surface and intracortical electrodes.

    PubMed

    Baziyan, B K; Gordeev, S A; Ivanova, M E; Ortmann, V V

    2008-01-01

    Parameters of phosphene-evoking electrical stimulation of cat striatal cortex via electrodes of different types (surface and intracortical) were studied. Similar actions (paw raising) in response to the light pattern and to phosphene-inducing electric stimulation of the striatal cortex were demonstrated. It seems that the animals associated phosphene sensations with light patterns.

  15. Perception of Suprasegmental Speech Features via Bimodal Stimulation: Cochlear Implant on One Ear and Hearing Aid on the Other

    ERIC Educational Resources Information Center

    Most, Tova; Harel, Tamar; Shpak, Talma; Luntz, Michal

    2011-01-01

    Purpose: The purpose of the study was to evaluate the contribution of acoustic hearing to the perception of suprasegmental features by adults who use a cochlear implant (CI) and a hearing aid (HA) in opposite ears. Method: 23 adults participated in this study. Perception of suprasegmental features--intonation, syllable stress, and word…

  16. Perception of Suprasegmental Speech Features via Bimodal Stimulation: Cochlear Implant on One Ear and Hearing Aid on the Other

    ERIC Educational Resources Information Center

    Most, Tova; Harel, Tamar; Shpak, Talma; Luntz, Michal

    2011-01-01

    Purpose: The purpose of the study was to evaluate the contribution of acoustic hearing to the perception of suprasegmental features by adults who use a cochlear implant (CI) and a hearing aid (HA) in opposite ears. Method: 23 adults participated in this study. Perception of suprasegmental features--intonation, syllable stress, and word…

  17. Subsequent Pulse Generator Replacement Surgery Does Not Increase the Infection Rate in Patients With Deep Brain Stimulator Systems: A Review of 1537 Unique Implants at a Single Center.

    PubMed

    Frizon, Leonardo A; Hogue, Olivia; Wathen, Connor; Yamamoto, Erin; Sabharwal, Navin C; Jones, Jaes; Volovetz, Josephine; Maldonado-Naranjo, Andres L; Lobel, Darlene A; Machado, Andre G; Nagel, Sean J

    2017-07-01

    Deep brain stimulation (DBS) is a well-recognized treatment for patients with movement disorders and other neurological diseases. The implantable pulse generator (IPG) is a fundamental component of the DBS system. Although IPG implantation and replacement surgeries are comparatively minor procedures relative to the brain lead insertion, patients often require multiple IPG replacements during their lifetime with each operation carrying a small but possibly cumulative risk of complications. To better educate our patients and improve surgical outcomes, we reviewed our series of patients at our institution. Using electronic health record data, we retrospectively reviewed all initial and subsequent IPG surgeries from patients who underwent at least one IPG surgery between the years of 2010 and 2015 at the Cleveland Clinic main campus. We calculated infection rates for initial IPG implantation surgeries and the infection rate for subsequent replacements. Fisher's exact tests were used to evaluate the chance of an infection between the initial implantation and replacement. Fisher's exact tests and simple logistic regression analyses were used to determine the predictive ability of selected demographic and clinical variables RESULTS: Our final sample included 697 patients and 1537 surgeries. For all patients, the infection rate at the first surgery was 2.01%; at the second surgery, it was 0.44%; and at the third surgery, it was 1.83%. When considering only patients that underwent at least three replacement surgeries (n = 114) the infection rate did not change in a significant manner with subsequent interventions compared to the first replacement. No other variable of interest was a significant predictor of infection. We did not find increasing rates of infection with subsequent IPG replacement procedures. © 2017 International Neuromodulation Society.

  18. Are there a guidelines for implantable spinal cord stimulator therapy in patients using chronic anticoagulation therapy? - A review of decision-making in the high-risk patient

    PubMed Central

    Ghaly, Ramsis F.; Lissounov, Alexei; Candido, Kenneth D.; Knezevic, Nebojsa Nick

    2016-01-01

    Background: Spinal cord stimulators (SCSs) are gaining increasing indications and utility in an expanding variety of clinical conditions. Complications and initial expenses have historically prevented the early use of SCS therapy despite ongoing efforts to educate and promote its utilization. At present, there exists no literature evidence of SCS implantation in a chronically anticoagulated patient, and neuromodulation manufacturers are conspicuously silent in providing warnings or recommendations in the face of anticoagulant use chronically. It would appear as through these issues demand scrutiny and industry as well as neuromodulation society advocacy and support in terms of the provision of coherent guidelines on how to proceed. Case Description: A 79-year-old male returned to the neurosurgical clinic with persistent low back pain and leg heaviness due to adjacent level degenerative spondylosis and severe thoracic spinal stenosis. The patient had a notable history of multiple comorbidities along with atrial fibrillation requiring chronic anticoagulation. On initial presentation, he was educated with three choice of conservative medical therapy, intrathecal drug delivery system implantation, or additional lumbar decompression laminectomy with instrumented fusion of T10-L3 and a palliative surgical lead SCS implantation. Description: A 79-year-old male returned to the neurosurgical clinic with persistent low back pain and leg heaviness due to adjacent level degenerative spondylosis and severe thoracic spinal stenosis. The patient had a notable history of multiple comorbidities along with atrial fibrillation requiring chronic anticoagulation. On initial presentation, he was educated with three choice of conservative medical therapy, intrathecal drug delivery system implantation, or additional lumbar decompression laminectomy with instrumented fusion of T10-L3 and a palliative surgical lead SCS implantation. Conclusion: Our literature search did not reveal any

  19. Intracranial electrode implantation produces regional neuroinflammation and memory deficits in rats

    SciTech Connect

    Kuttner-Hirshler, Y.; Biegon, A.; Kuttner-Hirshler, Y.; Polat, U.; Biegon, A.

    2009-12-21

    Deep brain stimulation (DBS) is an established treatment for advanced Parkinson's disease (PD). The procedure entails intracranial implantation of an electrode in a specific brain structure followed by chronic stimulation. Although the beneficial effects of DBS on motor symptoms in PD are well known, it is often accompanied by cognitive impairments, the origin of which is not fully understood. To explore the possible contribution of the surgical procedure itself, we studied the effect of electrode implantation in the subthalamic nucleus (STN) on regional neuroinflammation and memory function in rats implanted bilaterally with stainless steel electrodes. Age-matched sham and intact rats were used as controls. Brains were removed 1 or 8 weeks post-implantation and processed for in vitro autoradiography with [(3)H]PK11195, an established marker of microglial activation. Memory function was assessed by the novel object recognition test (ORT) before surgery and 2 and 8 weeks after surgery. Electrode implantation produced region-dependent changes in ligand binding density in the implanted brains at 1 as well as 8 weeks post-implantation. Cortical regions showed more intense and widespread neuroinflammation than striatal or thalamic structures. Furthermore, implanted animals showed deficits in ORT performance 2 and 8 weeks post-implantation. Thus, electrode implantation resulted in a widespread and persistent neuroinflammation and sustained memory impairment. These results suggest that the insertion and continued presence of electrodes in the brain, even without stimulation, may lead to inflammation-mediated cognitive deficits in susceptible individuals, as observed in patients treated with DBS.

  20. Continuous light after a long-day treatment is equivalent to melatonin implants to stimulate testosterone secretion in Alpine male goats.

    PubMed

    Delgadillo, J A; Vélez, L I; Flores, J A

    2016-04-01

    In rams, artificial long days followed by continuous light stimulate testosterone secretion during the non-breeding season. The objective of this study was to determine whether artificial long days followed by continuous light could stimulate testosterone secretion in Alpine bucks as well as in those exposed to long days followed by a melatonin treatment. All bucks were kept in shaded open pens. Control males were exposed to natural photoperiod conditions (n=5). Males of the two experimental groups were exposed to 2.5 months of long days from 1 December (n=5 each). On 16 February, one group of males was exposed to 24 h of light per day until 30 June; the other group was exposed to natural variations of photoperiod and received two s.c. melatonin implants. Testicular weight was determined every 2 weeks, and the plasma testosterone concentrations once a week. In the control and the two photoperiodic-treated groups, a treatment×time interaction was detected for testicular weight and plasma testosterone concentrations (P<0.001). In control bucks, testicular weight increased from January and peaked in June, whereas in both photoperiodic-treated groups, this variable increased from January, but peaked in April, when the values were higher than in controls (P<0.05). In the control group, plasma testosterone concentrations remained low from January to June, whereas in both photoperiodic-treated groups, this variable remained low from January to March; thereafter, these levels increased in both photoperiodic-treated groups, and were higher than controls in April and May (P<0.05). We conclude that continuous light after a long-day treatment stimulate testosterone secretion in Alpine male goats during the non-breeding season as well as the long days followed by a melatonin treatment. Therefore, continuous light could replace the implants of melatonin.

  1. Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study

    PubMed Central

    Roberts, Arthur; Sithole, Alec; Sedghi, Marcos; Walker, Charles A; Quinn, Theresa M

    2016-01-01

    The periauricular percutaneous implantation of the Neuro-Stim System™ family of devices EAD, MFS, and BRIDGE is a procedure involving the use of a non-opiate, neuromodulation analgesic for relieving acute and chronic pain. It has been approved as a minimal-risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleeding, localized dermatitis, and infections at the implantation sites of the electrode/needle arrays, dermatitis at the site of the generator, and patient syncope. A total of 1,207 devices, each producing up to 16 percutaneous punctures, for a total of 19,312 punctures were monitored for adverse effects, based on retrospective chart audits conducted at six clinical facilities over a 1-year period. PMID:27843360

  2. Microelectrode Guided Implantation of Electrodes into the Subthalamic Nucleus of Rats for Long-term Deep Brain Stimulation

    PubMed Central

    Fluri, Felix; Bieber, Micheal; Volkmann, Jens; Kleinschnitz, Christoph

    2015-01-01

    Deep brain stimulation (DBS) is a widely used and effective therapy for several neurologic disorders, such as idiopathic Parkinson’s disease, dystonia or tremor. DBS is based on the delivery of electrical stimuli to specific deep anatomic structures of the central nervous system. However, the mechanisms underlying the effect of DBS remain enigmatic. This has led to an interest in investigating the impact of DBS in animal models, especially in rats. As DBS is a long-term therapy, research should be focused on molecular-genetic changes of neural circuits that occur several weeks after DBS. Long-term DBS in rats is challenging because the rats move around in their cage, which causes problems in keeping in place the wire leading from the head of the animal to the stimulator. Furthermore, target structures for stimulation in the rat brain are small and therefore electrodes cannot easily be placed at the required position. Thus, a set-up for long-lasting stimulation of rats using platinum/iridium electrodes with an impedance of about 1 MΩ was developed for this study. An electrode with these specifications allows for not only adequate stimulation but also recording of deep brain structures to identify the target area for DBS. In our set-up, an electrode with a plug for the wire was embedded in dental cement with four anchoring screws secured onto the skull. The wire from the plug to the stimulator was protected by a stainless-steel spring. A swivel was connected to the circuit to prevent the wire from becoming tangled. Overall, this stimulation set-up offers a high degree of free mobility for the rat and enables the head plug, as well as the wire connection between the plug and the stimulator, to retain long-lasting strength. PMID:26485522

  3. Brain Activation in Response to Visceral Stimulation in Rats with Amygdala Implants of Corticosterone: An fMRI Study

    PubMed Central

    Johnson, Anthony C.; Myers, Brent; Lazovic, Jelena; Towner, Rheal; Greenwood-Van Meerveld, Beverley

    2010-01-01

    Background Although visceral pain of gastrointestinal (GI) origin is the major complaint in patients with irritable bowel syndrome (IBS) it remains poorly understood. Brain imaging studies suggest a defect in brain-gut communication in IBS with a greater activation of central arousal circuits including the amygdala. Previously, we found that stereotaxic implantation of corticosterone (CORT) onto the amygdala in rats induced anxiety and colonic hypersensitivity. In the present study we used functional magnetic resonance imaging (fMRI) to identify specific brain sites activated in a rat model characterized by anxiety and colonic hypersensitivity. Methodology/Principal Findings Anesthetized male rats received micropellets (30 µg each) of either CORT or cholesterol (CHOL), to serve as a control, implanted stereotaxically on the dorsal margin of each amygdala. Seven days later, rats were anesthetized and placed in the fMRI magnet (7T). A series of isobaric colorectal balloon distensions (CRD - 90s ‘off’, 30s ‘on’, 8 replicates) at two pressures (40 and 60 mmHg) were performed in a standard block-design. Cross correlation statistical analysis was used to determine significant differences between distended and non-distended states in CORT and CHOL-treated animals. Analysis of the imaging data demonstrated greater overall brain activation in response to CRD in rats with CORT implants compared to CHOL controls. Additionally, CORT implants produced significant positive bilateral increases in MRI signal in response to CRD in specific nuclei known as integration sites important in anxiety and pain perception. Conclusions and Significance These data indicate that chronic exposure of the amygdala to elevated levels of CORT enhances overall brain activation in response to CRD, and identified other specific brain regions activated in response to mechanical distension of the colon. These results demonstrate the feasibility of performing fMRI imaging in a rodent model that

  4. Construction and modeling of a reconfigurable MRI coil for lowering SAR in patients with deep brain stimulation implants.

    PubMed

    Golestanirad, Laleh; Iacono, Maria Ida; Keil, Boris; Angelone, Leonardo M; Bonmassar, Giorgio; Fox, Michael D; Herrington, Todd; Adalsteinsson, Elfar; LaPierre, Cristen; Mareyam, Azma; Wald, Lawrence L

    2017-02-15

    Post-operative MRI of patients with deep brain simulation (DBS) implants is useful to assess complications and diagnose comorbidities, however more than one third of medical centers do not perform MRIs on this patient population due to stringent safety restrictions and liability risks. A new system of reconfigurable magnetic resonance imaging head coil composed of a rotatable linearly-polarized birdcage transmitter and a close-fitting 32-channel receive array is presented for low-SAR imaging of patients with DBS implants. The novel system works by generating a region with low electric field magnitude and steering it to coincide with the DBS lead trajectory. We demonstrate that the new coil system substantially reduces the SAR amplification around DBS electrodes compared to commercially available circularly polarized coils in a cohort of 9 patient-derived realistic DBS lead trajectories. We also show that the optimal coil configuration can be reliably identified from the image artifact on B1(+) field maps. Our preliminary results suggest that such a system may provide a viable solution for high-resolution imaging of DBS patients in the future. More data is needed to quantify safety limits and recommend imaging protocols before the novel coil system can be used on patients with DBS implants.

  5. Stimulation of hepatic mitochondrial alpha-glycerophosphate dehydrogenase and malic enzyme by L-triiodothyronine. Characteristics of the response with specific nuclear thyroid hormone binding sites fully saturated.

    PubMed Central

    Oppenheimer, J H; Silva, E; Schwartz, H L; Surks, M I

    1977-01-01

    of an internally consistent mathematical model which permits prediction of enzyme response when the receptor sites are fully occupied for a given length of time after the i.v. injection of hormone. A separate series of studies was carried out in thyroidectomized rats. The response characteristics of alpha-GPD were similar to those observed in euthyroid animals. In contrast, however, the early response of ME to pulse injections of T3 was very much reduced in hypothyroid animals as compared to euthryoid animals in which nuclear sites were saturated for comparable periods. These findings raise the possibility that a factor required for the induction of malic enzyme but not alpha-GPD is deficient in the hypothyroid state. PMID:190269

  6. Improved cartilage regeneration by implantation of acellular biomaterials after bone marrow stimulation: a systematic review and meta-analysis of animal studies

    PubMed Central

    Pot, Michiel W.; Gonzales, Veronica K.; Buma, Pieter; IntHout, Joanna

    2016-01-01

    Microfracture surgery may be applied to treat cartilage defects. During the procedure the subchondral bone is penetrated, allowing bone marrow-derived mesenchymal stem cells to migrate towards the defect site and form new cartilage tissue. Microfracture surgery generally results in the formation of mechanically inferior fibrocartilage. As a result, this technique offers only temporary clinical improvement. Tissue engineering and regenerative medicine may improve the outcome of microfracture surgery. Filling the subchondral defect with a biomaterial may provide a template for the formation of new hyaline cartilage tissue. In this study, a systematic review and meta-analysis were performed to assess the current evidence for the efficacy of cartilage regeneration in preclinical models using acellular biomaterials implanted after marrow stimulating techniques (microfracturing and subchondral drilling) compared to the natural healing response of defects. The review aims to provide new insights into the most effective biomaterials, to provide an overview of currently existing knowledge, and to identify potential lacunae in current studies to direct future research. A comprehensive search was systematically performed in PubMed and EMBASE (via OvidSP) using search terms related to tissue engineering, cartilage and animals. Primary studies in which acellular biomaterials were implanted in osteochondral defects in the knee or ankle joint in healthy animals were included and study characteristics tabulated (283 studies out of 6,688 studies found). For studies comparing non-treated empty defects to defects containing implanted biomaterials and using semi-quantitative histology as outcome measure, the risk of bias (135 studies) was assessed and outcome data were collected for meta-analysis (151 studies). Random-effects meta-analyses were performed, using cartilage regeneration as outcome measure on an absolute 0–100% scale. Implantation of acellular biomaterials significantly

  7. The effect of step-synchronized vibration on patients with Parkinson's disease: case studies on subjects with freezing of gait or an implanted deep brain stimulator.

    PubMed

    Winfree, Kyle N; Pretzer-Aboff, Ingrid; Hilgart, David; Aggarwal, Rajeev; Behari, Madhuri; Agrawal, Sunil K

    2013-09-01

    Identifying noninvasive treatments to alleviate the symptoms of Parkinson's disease (PD) is important to improving the quality of life for those with PD. Several studies have explored the effects of visual, auditory, and vibratory cueing to improve gait in PD patients. Here, we present a wireless vibratory feedback system, called the PDShoe, and an associated intervention study with four subjects. The PDShoe was used on two control subjects, one subject with PD who experienced freezing of gait (FOG), and one subject with PD with an implanted deep brain stimulator (DBS). This short intervention study showed statistically significant improvements in peak heel pressure timing, peak toe pressure timing, time on the heel sensor, and stance to swing ratio after just one week of twice-daily therapy. Thus, step-synchronized vibration applied to the feet of patients with PD may be an effective way to improve gait in those subjects.

  8. Effect of mismatched place-of-stimulation on the salience of binaural cues in conditions that simulate bilateral cochlear-implant listening.

    PubMed

    Goupell, Matthew J; Stoelb, Corey; Kan, Alan; Litovsky, Ruth Y

    2013-04-01

    Although bilateral cochlear implantation has the potential to improve sound localization and speech understanding in noise, obstacles exist in presenting maximally useful binaural information to bilateral cochlear-implant (CI) users. One obstacle is that electrode arrays may differ in cochlear position by several millimeters, thereby stimulating different neural populations. Effects of interaural frequency mismatch on binaural processing were studied in normal-hearing (NH) listeners using band-limited pulse trains, thereby avoiding confounding factors that may occur in CI users. In experiment 1, binaural image fusion was measured to capture perceptual number, location, and compactness. Subjects heard a single, compact image on 73% of the trials. In experiment 2, intracranial image location was measured for different interaural time differences (ITDs) and interaural level differences (ILDs). For larger mismatch, locations perceptually shifted towards the ear with the higher carrier frequency. In experiment 3, ITD and ILD just-noticeable differences (JNDs) were measured. JNDs increased with decreasing bandwidth and increasing mismatch, but were always measurable up to 3 mm of mismatch. If binaural-hearing mechanisms are similar between NH and CI subjects, these results may explain reduced sensitivity of ITDs and ILDs in CI users. Large mismatches may lead to distorted spatial maps and reduced binaural image fusion.

  9. Predictive value of programmed ventricular stimulation in patients with ischaemic cardiomyopathy: implications for the selection of candidates for an implantable defibrillator.

    PubMed

    De Ferrari, Gaetano M; Rordorf, Roberto; Frattini, Folco; Petracci, Barbara; De Filippo, Paolo; Landolina, Maurizio

    2007-12-01

    The present study assessed the role of programmed ventricular stimulation (PVS) in risk stratification of patients with ischaemic cardiomyopathy (ICM), candidates for implantable cardioverter-defibrillator (ICD). Consecutive patients with ICM and LVEF < or = 40% (n = 106, age 61 +/- 7 years, LVEF 27 +/- 7%) underwent PVS. This was considered positive in case of inducibility of monomorphic ventricular tachycardia (VT) with < or =3 extrastimuli; polymorphic VT, ventricular fibrillation (VF), and fast monomorphic VT (CL < or = 230 ms) with < or =2 extrastimuli. Primary end-point was the combination of arrhythmic death and VF requiring ICD shock. Forty-nine patients (46%) were inducible at PVS; 74 (70%) were implanted with ICD. During a 24-month follow-up, the primary end-point occurred more frequently in positive PVS patients among the overall population, among patients with LVEF < or = 30% (n = 80) and among patients with an ICD. The negative predictive value of PVS was 96% in each group. In the overall population, both PVS (HR 7.32, 95% CI 1.6-32) and LVEF (HR 4.59, 95% CI 1.6-13) predicted the primary end-point. PVS may still have a role in predicting the arrhythmic risk in patients with ICM. A negative PVS identifies a subgroup with a very low risk of arrhythmic events even in patients with LVEF < or = 30%.

  10. Intonation of musical intervals by musical intervals by deaf subjects stimulated with single bipolar cochlear implant electrodes.

    PubMed

    Pijl, S; Schwarz, D W

    1995-09-01

    Some subjects with cochlear implants have been shown to associate electrical stimulus pulse rates with the pitches of musical tones. In order to clarify the role of these pitch sensations in a musical context, the present investigation examined the intonation accuracy achieved by implant subjects when adjusting pulse rates in the reconstruction of musical intervals. Using a method of adjustment, the subjects altered a variable pulse rate, relative to a fixed reference rate, on one electrode, in the tuning of musical intervals abstracted from familiar melodies. At low pulse rates, subjects generally tuned the intervals to the same frequency ratios which define tonal musical intervals in normal-hearing listeners, with error margins comparable to musically untrained subjects. Two subjects were, in addition, able to transpose these melodic intervals from a standard reference pulse rate to higher and lower reference rates (reference and target pulse rates with geometric means of the intervals ranging from 81 to 466 pulses/s). Generally, the intervals were adjusted on a ratio scale, according to the same frequency ratios which define analogous acoustical musical intervals. These results support the hypothesis that, at low pulse rates, a temporal code in the auditory nerve alone is capable of defining musical pitch.

  11. Combined Electric and Acoustic Stimulation With Hearing Preservation: Effect of Cochlear Implant Low-Frequency Cutoff on Speech Understanding and Perceived Listening Difficulty.

    PubMed

    Gifford, René H; Davis, Timothy J; Sunderhaus, Linsey W; Menapace, Christine; Buck, Barbara; Crosson, Jillian; O'Neill, Lori; Beiter, Anne; Segel, Phil

    The primary objective of this study was to assess the effect of electric and acoustic overlap for speech understanding in typical listening conditions using semidiffuse noise. This study used a within-subjects, repeated measures design including 11 experienced adult implant recipients (13 ears) with functional residual hearing in the implanted and nonimplanted ear. The aided acoustic bandwidth was fixed and the low-frequency cutoff for the cochlear implant (CI) was varied systematically. Assessments were completed in the R-SPACE sound-simulation system which includes a semidiffuse restaurant noise originating from eight loudspeakers placed circumferentially about the subject's head. AzBio sentences were presented at 67 dBA with signal to noise ratio varying between +10 and 0 dB determined individually to yield approximately 50 to 60% correct for the CI-alone condition with full CI bandwidth. Listening conditions for all subjects included CI alone, bimodal (CI + contralateral hearing aid), and bilateral-aided electric and acoustic stimulation (EAS; CI + bilateral hearing aid). Low-frequency cutoffs both below and above the original "clinical software recommendation" frequency were tested for all patients, in all conditions. Subjects estimated listening difficulty for all conditions using listener ratings based on a visual analog scale. Three primary findings were that (1) there was statistically significant benefit of preserved acoustic hearing in the implanted ear for most overlap conditions, (2) the default clinical software recommendation rarely yielded the highest level of speech recognition (1 of 13 ears), and (3) greater EAS overlap than that provided by the clinical recommendation yielded significant improvements in speech understanding. For standard-electrode CI recipients with preserved hearing, spectral overlap of acoustic and electric stimuli yielded significantly better speech understanding and less listening effort in a laboratory-based, restaurant

  12. Cathodic Voltage-controlled Electrical Stimulation Plus Prolonged Vancomycin Reduce Bacterial Burden of a Titanium Implant-associated Infection in a Rodent Model.

    PubMed

    Nodzo, Scott R; Tobias, Menachem; Ahn, Richard; Hansen, Lisa; Luke-Marshall, Nicole R; Howard, Craig; Wild, Linda; Campagnari, Anthony A; Ehrensberger, Mark T

    2016-07-01

    Cathodic voltage-controlled electrical stimulation (CVCES) of titanium implants, either alone or combined with a short course of vancomycin, has previously been shown to reduce the bone and implant bacterial burden in a rodent model of methicillin-resistant Staphylococcus aureus (MRSA) implant-associated infection (IAI). Clinically, the goal is to achieve complete eradication of the IAI; therefore, the rationale for the present study was to evaluate the antimicrobial effects of combining CVCES with prolonged antibiotic therapy with the goal of decreasing the colony-forming units (CFUs) to undetectable levels. (1) In an animal MRSA IAI model, does combining CVCES with prolonged vancomycin therapy decrease bacteria burden on the implant and surrounding bone to undetectable levels? (2) When used with prolonged vancomycin therapy, are two CVCES treatments more effective than one? (3) What are the longer term histologic effects (inflammation and granulation tissue) of CVCES on the surrounding tissue? Twenty adult male Long-Evans rats with surgically placed shoulder titanium implants were infected with a clinical strain of MRSA (NRS70). One week after infection, the rats were randomly divided into four groups of five: (1) VANCO: only vancomycin treatment (150 mg/kg, subcutaneous, twice daily for 5 weeks); (2) VANCO + 1STIM: vancomycin treatment (same as the VANCO group) coupled with one CVCES treatment (-1.8 V for 1 hour on postoperative day [POD] 7); (3) VANCO + 2STIM: vancomycin treatment (same as the VANCO group) coupled with two CVCES treatments (-1.8 V for 1 hour on POD 7 and POD 21); or (4) CONT: no treatment. On POD 42, the implant, bone, and peripheral blood were collected for CFU enumeration and histological analysis, where we compared CFU/mL on the implants and bone among the groups. A pathologist, blinded to the experimental conditions, performed a semiquantitative analysis of inflammation and granulation tissue present in serial sections of the humeral head

  13. Implantation of electrodes for deep brain stimulation of the subthalamic nucleus in advanced Parkinson's disease with the aid of intraoperative microrecording under general anesthesia.

    PubMed

    Hertel, Frank; Züchner, Mark; Weimar, Inge; Gemmar, Peter; Noll, Bernhard; Bettag, Martin; Decker, Christian

    2006-11-01

    Deep brain stimulation (DBS) is widely accepted in the treatment of advanced Parkinson's disease (PD) and other movement disorders. The standard implantation procedure is performed under local anesthesia (LA). Certain groups of patients may not be eligible for surgery under LA because of clinical reasons, such as massive fear, reduced cooperativity, or coughing attacks. Microrecording (MER) has been shown to be helpful in DBS surgery. The purpose of this study was to evaluate the feasibility of MER for DBS surgery under general anesthesia (GA) and to compare the data of intraoperative MER as well as the clinical data with that of the current literature of patients undergoing operation under LA. The data of nine patients with advanced PD (mean Hoehn and Yahr status, 4.2) who were operated with subthalamic nucleus (STN) DBS under GA, owing to certain clinical circumstances ruling out DBS under LA, were retrospectively analyzed. All operations were performed under analgosedation with propofol or remifentanil and intraoperative MER. For MER, remifentanil was ceased completely and propofol was lowered as far as possible. The STN could be identified intraoperatively in all patients with MER. The typical bursting pattern was identified, whereas a widening of the baseline noise could not be as adequately detected as in patients under LA. The daily off phases of the patients were reduced from 50 to 17%, whereas the Unified Parkinson's Disease Rating Scale III score was reduced from 43 (preoperative, medication off) to 19 (stimulation on, medication off) and 12 (stimulation on, medication on). Two patients showed a transient neuropsychological deterioration after surgery, but both also had preexisting episodes of disorientation. One implantable pulse generator infection was noticed. No further significant clinical complications were observed. STN surgery for advanced PD with MER guidance is possible with good clinical results under GA. Intraoperative MER of the STN region

  14. Energetic analysis for self-powered cochlear implants.

    PubMed

    Accoto, D; Calvano, M; Campolo, D; Salvinelli, F; Guglielmelli, E

    2009-01-01

    Cochlear implants (CIs) are used for compensating the so-called deep sensorineural deafness. CIs are usually powered by rechargeable or long-lasting batteries. In this paper, the feasibility of a fully implanted stand-alone device able to provide the electric power required for stimulating the auditory nerve, without external recharging, is investigated. At first, we demonstrate that the sound wave entering the ear is not a sufficient power source. Then, we propose a solution exploiting the mechanical energy associated to head vibration during walking. The energetic feasibility of this approach is demonstrated based on experimental measurements of head motions. Preliminary considerations on the technical feasibility of a fully implanted energy harvester are finally presented.

  15. A comparative historical and demographic study of the neuromodulation management techniques of deep brain stimulation for dystonia and cochlear implantation for sensorineural deafness in children.

    PubMed

    Hudson, V E; Elniel, A; Ughratdar, I; Zebian, B; Selway, R; Lin, J P

    2017-01-01

    Cochlear implants for sensorineural deafness in children is one of the most successful neuromodulation techniques known to relieve early chronic neurodisability, improving activity and participation. In 2012 there were 324,000 recipients of cochlear implants globally.

  16. [Cochlear implant in adults].

    PubMed

    Bouccara, D; Mosnier, I; Bernardeschi, D; Ferrary, E; Sterkers, O

    2012-03-01

    Cochlear implant in adults is a procedure, dedicated to rehabilitate severe to profound hearing loss. Because of technological progresses and their applications for signal strategies, new devices can improve hearing, even in noise conditions. Binaural stimulation, cochlear implant and hearing aid or bilateral cochlear implants are the best opportunities to access to better level of comprehension in all conditions and space localisation. By now minimally invasive surgery is possible to preserve residual hearing and use a double stimulation modality for the same ear: electrical for high frequencies and acoustic for low frequencies. In several conditions, cochlear implant is not possible due to cochlear nerve tumour or major malformations of the inner ear. In these cases, a brainstem implantation can be considered. Clinical data demonstrate that improvement in daily communication, for both cochlear and brainstem implants, is correlated with cerebral activation of auditory cortex.

  17. The effects of stochastic neural activity in a model predicting intensity perception with cochlear implants: low-rate stimulation.

    PubMed

    Bruce, I C; White, M W; Irlicht, L S; O'Leary, S J; Clark, G M

    1999-12-01

    Most models of auditory nerve response to electrical stimulation are deterministic, despite significant physiological evidence for stochastic activity. Furthermore, psychophysical models and analyses of physiological data using deterministic descriptions do not accurately predict many psychophysical phenomena. In this paper we investigate whether inclusion of stochastic activity in neural models improves such predictions. To avoid the complication of interpulse interactions and to enable the use of a simpler and faster auditory nerve model we restrict our investigation to single pulses and low-rate (< 200 pulses/s) pulse trains. We apply signal detection theory to produce direct predictions of behavioral threshold, dynamic range and intensity difference limen. Specifically, we investigate threshold versus pulse duration (the strength-duration characteristics), threshold and uncomfortable loudness (and the corresponding dynamic range) versus phase duration, the effects of electrode configuration on dynamic range and on strength-duration, threshold versus number of pulses (the temporal-integration characteristics), intensity difference limen as a function of loudness, and the effects of neural survival on these measures. For all psychophysical measures investigated, the inclusion of stochastic activity in the auditory nerve model was found to produce more accurate predictions.

  18. Integrated approach for smart implantable cardioverter defibrillator (ICD) device with real time ECG monitoring: use of flexible sensors for localized arrhythmia sensing and stimulation

    PubMed Central

    Puri, Munish; Chapalamadugu, Kalyan C.; Miranda, Aimon C.; Gelot, Shyam; Moreno, Wilfrido; Adithya, Prashanth C.; Law, Catherine; Tipparaju, Srinivas M.

    2013-01-01

    Arrhythmias are the most common cause of death associated with sudden death and are common in US and worldwide. Cardiac resynchronization therapy (CRT), evolving from pacemakers and development of implantable cardioverter defibrillator (ICD), has been adopted for therapeutic use and demonstrated benefits in patients over the years due to its design and intricate functionality. Recent research has been focused on significant design improvement and efforts are dedicated toward device size reduction, weight and functionality in commercially available ICD's since its invention in the 1960's. Commercially available CRT-D has shown advancement on both clinical and technical side. However, improved focus is required on the device miniaturization, technologically supported and integrated wireless based system for real time heart monitoring electrocardiogram (ECG). In the present report a concise overview for the state-of-the art technology in ICDs and avenues for future development are presented. A unique perspective is also included for ICD device miniaturization and integration of flexible sensing array. Sensor array integration along with its capabilities for identifying localized arrhythmia detection and targeted stimulation for enhancing ICD device capabilities is reviewed. PMID:24167492

  19. Fully Passive Wireless Acquisition of Neuropotentials

    NASA Astrophysics Data System (ADS)

    Schwerdt, Helen N.

    The ability to monitor electrophysiological signals from the sentient brain is requisite to decipher its enormously complex workings and initiate remedial solutions for the vast amount of neurologically-based disorders. Despite immense advancements in creating a variety of instruments to record signals from the brain, the translation of such neurorecording instrumentation to real clinical domains places heavy demands on their safety and reliability, both of which are not entirely portrayed by presently existing implantable recording solutions. In an attempt to lower these barriers, alternative wireless radar backscattering techniques are proposed to render the technical burdens of the implant chip to entirely passive neurorecording processes that transpire in the absence of formal integrated power sources or powering schemes along with any active circuitry. These radar-like wireless backscattering mechanisms are used to conceive of fully passive neurorecording operations of an implantable microsystem. The fully passive device potentially manifests inherent advantages over current wireless implantable and wired recording systems: negligible heat dissipation to reduce risks of brain tissue damage and minimal circuitry for long term reliability as a chronic implant. Fully passive neurorecording operations are realized via intrinsic nonlinear mixing properties of the varactor diode. These mixing and recording operations are directly activated by wirelessly interrogating the fully passive device with a microwave carrier signal. This fundamental carrier signal, acquired by the implant antenna, mixes through the varactor diode along with the internal targeted neuropotential brain signals to produce higher frequency harmonics containing the targeted neuropotential signals. These harmonics are backscattered wirelessly to the external interrogator that retrieves and recovers the original neuropotential brain signal. The passive approach removes the need for internal power

  20. The "neuro-mapping locator" software. A real-time intraoperative objective paraesthesia mapping tool to evaluate paraesthesia coverage of the painful zone in patients undergoing spinal cord stimulation lead implantation.

    PubMed

    Guetarni, F; Rigoard, P

    2015-03-01

    Conventional spinal cord stimulation (SCS) generates paraesthesia, as the efficacy of this technique is based on the relationship between the paraesthesia provided by SCS on the painful zone and an analgesic effect on the stimulated zone. Although this basic postulate is based on clinical evidence, it is clear that this relationship has never been formally demonstrated by scientific studies. There is a need for objective evaluation tools ("transducers") to transpose electrical signals to clinical effects and to guide therapeutic choices. We have developed a software at Poitiers University hospital allowing real-time objective mapping of the paraesthesia generated by SCS lead placement and programming during the implantation procedure itself, on a touch screen interface. The purpose of this article is to describe this intraoperative mapping software, in terms of its concept and technical aspects. The Neuro-Mapping Locator (NML) software is dedicated to patients with failed back surgery syndrome, candidates for SCS lead implantation, to actively participate in the implantation procedure. Real-time geographical localization of the paraesthesia generated by percutaneous or multicolumn surgical SCS lead implanted under awake anaesthesia allows intraoperative lead programming and possibly lead positioning to be modified with the patient's cooperation. Software updates should enable us to refine objectives related to the use of this tool and minimize observational biases. The ultimate goals of NML software should not be limited to optimize one specific device implantation in a patient but also allow to compare instantaneously various stimulation strategies, by characterizing new technical parameters as "coverage efficacy" and "device specificity" on selected subgroups of patients. Another longer-term objective would be to organize these predictive factors into computer science ontologies, which could constitute robust and helpful data for device selection and programming

  1. Brain imaging correlates of peripheral nerve stimulation

    PubMed Central

    Bari, Ausaf A.; Pouratian, Nader

    2012-01-01

    Direct peripheral nerve stimulation is an effective treatment for a number of disorders including epilepsy, depression, neuropathic pain, cluster headache, and urological dysfunction. The efficacy of this stimulation is ultimately due to modulation of activity in the central nervous system. However, the exact brain regions involved in each disorder and how they are modulated by peripheral nerve stimulation is not fully understood. The use of functional neuroimaging such as SPECT, PET and fMRI in patients undergoing peripheral nerve stimulation can help us to understand these mechanisms. We review the literature for functional neuroimaging performed in patients implanted with peripheral nerve stimulators for the above-mentioned disorders. These studies suggest that brain activity in response to peripheral nerve stimulation is a complex interaction between the stimulation parameters, disease type and severity, chronicity of stimulation, as well as nonspecific effects. From this information we may be able to understand which brain structures are involved in the mechanism of peripheral nerve stimulation as well as define the neural substrates underlying these disorders. PMID:23230531

  2. Self-Tracking Energy Transfer for Neural Stimulation in Untethered Mice

    NASA Astrophysics Data System (ADS)

    Ho, John S.; Tanabe, Yuji; Iyer, Shrivats Mohan; Christensen, Amelia J.; Grosenick, Logan; Deisseroth, Karl; Delp, Scott L.; Poon, Ada S. Y.

    2015-08-01

    Optical or electrical stimulation of neural circuits in mice during natural behavior is an important paradigm for studying brain function. Conventional systems for optogenetics and electrical microstimulation require tethers or large head-mounted devices that disrupt animal behavior. We report a method for wireless powering of small-scale implanted devices based on the strong localization of energy that occurs during resonant interaction between a radio-frequency cavity and intrinsic modes in mice. The system features self-tracking over a wide (16-cm diameter) operational area, and is used to demonstrate wireless activation of cortical neurons with miniaturized stimulators (10 mm3 , 20 mg) fully implanted under the skin.

  3. Response to programmed ventricular stimulation and clinical outcome in cardiac arrest survivors receiving randomised assignment to implantable cardioverter defibrillator or antiarrhythmic drug therapy.

    PubMed

    Cappato, Riccardo; Boczor, Sigrid; Kuck, Karl-Heinz

    2004-04-01

    Using a prospective design which randomly assigned implantable cardioverter defibrillator (ICD) versus antiarrhythmic drugs (AADs), we investigated the usefulness of programmed ventricular stimulation (PVS) for prediction of outcome and therapy effectiveness in cardiac arrest (CA) survivors. We performed baseline PVS in 285 survivors of CA enrolled in the Cardiac Arrest Study Hamburg (CASH) and randomised to ICDs or AADs. Sustained ventricular arrhythmia (VA) was induced in 134 (47.0%) patients. We compared the outcomes of different subgroups based on response to baseline PVS and randomly assigned therapy. Patients were followed for a median of 55 months. The raw death rate was greater among inducible (51.3% [95% CI: 44.9-58.3%]) than non-inducible patients (28.8% [CI: 23.4-36.1%, p = 0.0003]). When challenged in a multivariate model, inducibility still had an independent power for predicting all-cause death (hazard ratio (HR), 1.5 [95% CI, 1.1-2.3], p = 0.041), but not sudden death (SD) (HR, 1.2 [95% CI, 0.7-3.6], p = 0.162). Subgroup analysis showed that, when compared to AADs, assignment to ICDs was associated with a lower risk of all-cause death (HR, 0.4 [95% CI, 0.1-0.9], p = 0.044) in patients with EF < or =0.35 and non-inducible arrhythmias, but not in other patient subgroups. In CA survivors, inducibility at baseline PVS is independently associated with an increased risk of all-cause death, but not SD. In addition, response to PVS may help to identify subgroups of patients who could most benefit from ICD.

  4. [Complications related with implanted devices in patients with Parkinson's disease treated with deep brain stimulation. A study of a series of 124 patients over a period of 16 years].

    PubMed

    de Quintana-Schmidt, C; Pascual-Sedano, Berta; Alvarez-Holzapfel, M Jesús; Gironell, Alexandre; Leidinger, Andreas; Benito, Natividad; Rodríguez-Rodríguez, Rodrigo; Molet-Teixidó, Joan

    2014-07-16

    Establishing protocols of the best candidates for deep brain stimulation in patients with Parkinson's disease and a greater knowledge of the technique have increased its safety profile. Yet, the complications related with implanted devices still occur with a far-from-negligible frequency and have both an economic and clinical impact. From a broad series of patients undergoing deep brain stimulation included consecutively for the treatment of their Parkinson's disease, data concerning the complications related with implanted devices were gathered and compared with those in the literature. Altogether 124 patients with a total of 242 implanted electrodes and 252 generator replacements were included in the study. Mean follow-up time was 8.4 years (range: 3-16 years). Data on all the complications related with implanted devices were collected retrospectively. Findings showed that 23 implanted device-related complications occurred (17.7% of the patients): 12 (9.6%) had culture-positive ulcers, five (4%) had culture-negative ulcers, four (3.2%) were left with infections following generator replacement, one (0.8%) had a generator malfunction, and electrode migration took place in one (0.8%). Significant differences were observed as regards the effectiveness of the treatment involving surgical revision of the ulcers, which suggests that the culture-negative ulcers responded to the surgical revision better than the culture-positive ulcers (80% healing versus 16.6%; p = 0.028). The results observed in the series were comparable to those in the existing literature. The presence of culture-positivity in the ulcers is a factor forecasting surgical revision.

  5. Effect of implant design on initial stability of tapered implants.

    PubMed

    Chong, Linus; Khocht, Ahmed; Suzuki, Jon B; Gaughan, John

    2009-01-01

    Implant design is one of the parameters for achieving successful primary stability. This study aims to examine the effect of a self-tapping blades implant design on initial stability in tapered implants. Polyurethane blocks of different densities were used to simulate different bone densities. The two different implant designs included one with self-tapping blades and one without self-tapping blades. Implants were placed at 3 different depths: apical third, middle third, and fully inserted at 3 different densities of polyurethane blocks. A resonance frequency (RF) analyzer was then used to measure stability of the implants. Repeated-measures analysis of variance was used to examine the effect of implant design, insertion depth, and block density on RF. Analysis of covariance was used to examine the strength of association between RF and the aforementioned factors. In both medium-density (P = .017) and high-density (P = .002) blocks, fully inserted non-self-tapping implants showed higher initial stability than self-tapping implants. No differences were noted between the 2 implant designs that were not fully inserted. The highest strength of association was with insertion depth (standardized beta [std beta] = -0.60, P = .0001), followed by block density (std beta = -0.15, P = .0002). Implant design showed a weak association (std beta = -0.07, P = .09). In conclusion, fully inserted implants without self-tapping blades have higher initial stability than implants with self-tapping blades. However, the association strength between implant design and initial stability is less relevant than other factors, such as insertion depth and block density. Thus, if bone quality and quantity are optimal, they may compensate for design inadequacy.

  6. Infection of Brindley sacral anterior root stimulator by Pseudomonas aeruginosa requiring removal of the implant: long-term deleterious effects on bowel and urinary bladder function in a spinal cord injury patient with tetraplegia: a case report

    PubMed Central

    2009-01-01

    Introduction We report infection of Brindley sacral anterior root stimulator in a spinal cord injury patient, who ultimately required removal of the implant. The consequences of failed implantation were severe constipation, and loss of reflex penile erection and bladder emptying. Case presentation A male patient, born in 1973, fell off the balcony while on holidays in Crete in 1993 and developed complete tetraplegia at C-5 level. In 1996, deafferentation of sacral nerve roots 2, 3 and 4 were carried out bilaterally. Brindley sacral anterior root stimulator was implanted. On eleventh post-operative day, blood stained fluid came out of sacral wound. Microbiology of exudates showed growth of Pseudomonas aeruginosa, sensitive to gentamicin. As discharge of serosanguinous fluid persisted, sacral wound was explored. In March 1997, induration and craggy swelling were noted at the site of receiver. There was discharge from the surgical wound in the back. Wound swab grew Pseudomonas aeruginosa. The receiver was taken out. Cables were retrieved and tunnelled in left flank. Laminectomy wound was left open. In May 1997, cables were removed from left flank through the laminectomy wound. Grommet was sliced down as much as possible without producing leak of cerebrospinal fluid. Histoacryl glue was used over the truncated grommet as a sealing agent. Microbiology of end of S-2 and S-3 cables showed growth of Pseudomonas aeruginosa, which was sensitive to gentamicin. End of S-4 cable showed scanty growth of Pseudomonas aeruginosa and Klebsiella aerogenes. Review of this patient in January 1999 revealed presence of sinuses in dorsal wound exuding purulent material. The wound was explored; grommet and electrodes were removed. The consequences of failed implantation were severe constipation and loss of reflex penile erection and bladder emptying. This patient had to spend increasing amount of time for bowels management. Faecal incontinence limited his mobility. The problem with his

  7. Intracranial electrode implantation produces regional neuroinflammation and memory deficits in rats

    PubMed Central

    Hirshler, Yafit (Kuttner); Polat, Uri; Biegon, Anat

    2009-01-01

    Deep brain stimulation (DBS) is an established treatment for advanced Parkinson’s disease (PD). The procedure entails intracranial implantation of an electrode in a specific brain structure followed by chronic stimulation. Although the beneficial effects of DBS on motor symptoms in PD are well known, it is often accompanied by cognitive impairments the origin of which is not fully understood. To explore the possible contribution of the surgical procedure itself, we studied the effect of electrode implantation in the subthalamic nucleus (STN) on regional neuroinflammation and memory function in rats implanted bilaterally with stainless steel electrodes. Age-matched sham and intact rats were used as controls. Brains were removed one week or eight weeks post implantation and processed for in vitro autoradiography with [3H]PK11195, an established marker of microglial activation. Memory function was assessed by the novel object recognition test (ORT) before surgery and two and eight weeks after surgery. Electrode implantation produced region-dependent changes in ligand binding density in the implanted brains at one week as well as eight weeks post implantation. Cortical regions showed more intense and widespread neuroinflammation than striatal or thalamic structures. Furthermore, implanted animals showed deficits in ORT performance two and eight weeks post implantation. Thus, electrode implantation resulted in a widespread and persistent neuroinflammation and sustained memory impairment. These results suggest that the insertion and continued presence of electrodes in the brain, even without stimulation, may lead to inflammation-mediated cognitive deficits in susceptible individuals, as observed in patients treated with DBS. PMID:20026042

  8. Cochlear Implants

    MedlinePlus

    ... Medical Procedures Implants and Prosthetics Cochlear Implants Cochlear Implants Share Tweet Linkedin Pin it More sharing options ... normal ear, ear with hearing loss, and cochlear implant procedure Welcome to the Food and Drug Administration ( ...

  9. Estimating dose to implantable cardioverter-defibrillator outside the treatment fields using a skin QED diode, optically stimulated luminescent dosimeters, and LiF thermoluminescent dosimeters

    SciTech Connect

    Chan, Maria F.; Song, Yulin; Dauer, Lawrence T.; Li Jingdong; Huang, David; Burman, Chandra

    2012-10-01

    The purpose of this work was to determine the relative sensitivity of skin QED diodes, optically stimulated luminescent dosimeters (OSLDs) (microStar Trade-Mark-Sign DOT, Landauer), and LiF thermoluminescent dosimeters (TLDs) as a function of distance from a photon beam field edge when applied to measure dose at out-of-field points. These detectors have been used to estimate radiation dose to patients' implantable cardioverter-defibrillators (ICDs) located outside the treatment field. The ICDs have a thin outer case made of 0.4- to 0.6-mm-thick titanium ({approx}2.4-mm tissue equivalent). A 5-mm bolus, being the equivalent depth of the devices under the patient's skin, was placed over the ICDs. Response per unit absorbed dose-to-water was measured for each of the dosimeters with and without bolus on the beam central axis (CAX) and at a distance up to 20 cm from the CAX. Doses were measured with an ionization chamber at various depths for 6- and 15-MV x-rays on a Varian Clinac-iX linear accelerator. Relative sensitivity of the detectors was determined as the ratio of the sensitivity at each off-axis distance to that at the CAX. The detector sensitivity as a function of the distance from the field edge changed by {+-} 3% (1-11%) for LiF TLD-700, decreased by 10% (5-21%) for OSLD, and increased by 16% (11-19%) for the skin QED diode (Sun Nuclear Corp.) at the equivalent depth of 5 mm for 6- or 15-MV photon energies. Our results showed that the use of bolus with proper thickness (i.e., {approx}d{sub max} of the photon energy) on the top of the ICD would reduce the scattered dose to a lower level. Dosimeters should be calibrated out-of-field and preferably with bolus equal in thickness to the depth of interest. This can be readily performed in clinic.

  10. Estimating dose to implantable cardioverter-defibrillator outside the treatment fields using a skin QED diode, optically stimulated luminescent dosimeters, and LiF thermoluminescent dosimeters.

    PubMed

    Chan, Maria F; Song, Yulin; Dauer, Lawrence T; Li, Jingdong; Huang, David; Burman, Chandra

    2012-01-01

    The purpose of this work was to determine the relative sensitivity of skin QED diodes, optically stimulated luminescent dosimeters (OSLDs) (microStar™ DOT, Landauer), and LiF thermoluminescent dosimeters (TLDs) as a function of distance from a photon beam field edge when applied to measure dose at out-of-field points. These detectors have been used to estimate radiation dose to patients' implantable cardioverter-defibrillators (ICDs) located outside the treatment field. The ICDs have a thin outer case made of 0.4- to 0.6-mm-thick titanium (∼2.4-mm tissue equivalent). A 5-mm bolus, being the equivalent depth of the devices under the patient's skin, was placed over the ICDs. Response per unit absorbed dose-to-water was measured for each of the dosimeters with and without bolus on the beam central axis (CAX) and at a distance up to 20 cm from the CAX. Doses were measured with an ionization chamber at various depths for 6- and 15-MV x-rays on a Varian Clinac-iX linear accelerator. Relative sensitivity of the detectors was determined as the ratio of the sensitivity at each off-axis distance to that at the CAX. The detector sensitivity as a function of the distance from the field edge changed by ± 3% (1-11%) for LiF TLD-700, decreased by 10% (5-21%) for OSLD, and increased by 16% (11-19%) for the skin QED diode (Sun Nuclear Corp.) at the equivalent depth of 5 mm for 6- or 15-MV photon energies. Our results showed that the use of bolus with proper thickness (i.e., ∼d(max) of the photon energy) on the top of the ICD would reduce the scattered dose to a lower level. Dosimeters should be calibrated out-of-field and preferably with bolus equal in thickness to the depth of interest. This can be readily performed in clinic. Copyright © 2012 American Association of Medical Dosimetrists. Published by Elsevier Inc. All rights reserved.

  11. Towards biodegradable wireless implants.

    PubMed

    Boutry, Clémentine M; Chandrahalim, Hengky; Streit, Patrick; Schinhammer, Michael; Hänzi, Anja C; Hierold, Christofer

    2012-05-28

    A new generation of partially or even fully biodegradable implants is emerging. The idea of using temporary devices is to avoid a second surgery to remove the implant after its period of use, thereby improving considerably the patient's comfort and safety. This paper provides a state-of-the-art overview and an experimental section that describes the key technological challenges for making biodegradable devices. The general considerations for the design and synthesis of biodegradable components are illustrated with radiofrequency-driven resistor-inductor-capacitor (RLC) resonators made of biodegradable metals (Mg, Mg alloy, Fe, Fe alloys) and biodegradable conductive polymer composites (polycaprolactone-polypyrrole, polylactide-polypyrrole). Two concepts for partially/fully biodegradable wireless implants are discussed, the ultimate goal being to obtain a fully biodegradable sensor for in vivo sensing.

  12. [A comparison of time resolution among auditory, tactile and promontory electrical stimulation--superiority of cochlear implants as human communication aids].

    PubMed

    Matsushima, J; Kumagai, M; Harada, C; Takahashi, K; Inuyama, Y; Ifukube, T

    1992-09-01

    Our previous reports showed that second formant information, using a speech coding method, could be transmitted through an electrode on the promontory. However, second formant information can also be transmitted by tactile stimulation. Therefore, to find out whether electrical stimulation of the auditory nerve would be superior to tactile stimulation for our speech coding method, the time resolutions of the two modes of stimulation were compared. The results showed that the time resolution of electrical promontory stimulation was three times better than the time resolution of tactile stimulation of the finger. This indicates that electrical stimulation of the auditory nerve is much better for our speech coding method than tactile stimulation of the finger.

  13. Fully Regressive Melanoma

    PubMed Central

    Ehrsam, Eric; Kallini, Joseph R.; Lebas, Damien; Modiano, Philippe; Cotten, Hervé

    2016-01-01

    Fully regressive melanoma is a phenomenon in which the primary cutaneous melanoma becomes completely replaced by fibrotic components as a result of host immune response. Although 10 to 35 percent of cases of cutaneous melanomas may partially regress, fully regressive melanoma is very rare; only 47 cases have been reported in the literature to date. AH of the cases of fully regressive melanoma reported in the literature were diagnosed in conjunction with metastasis on a patient. The authors describe a case of fully regressive melanoma without any metastases at the time of its diagnosis. Characteristic findings on dermoscopy, as well as the absence of melanoma on final biopsy, confirmed the diagnosis. PMID:27672418

  14. [Clinical Results after Implantation of Epiretinal Visual Prostheses].

    PubMed

    Schimitzek, H; Roessler, G; Walter, P

    2016-11-01

    Epiretinal visual prostheses have already been implanted in blind retinitis pigmentosa (RP) patients. Here we report on clinical experience with the Argus® II device and the EPIRET 3 device, on the basis of data from patients operated in Germany. Twenty-eight patients were implanted with the Argus II device and followed for up to three years. EPIRET 3 was implanted in six patients for a period of four weeks. With Argus II, an improvement in visual performance was achieved in the majority of cases, as demonstrated by improved localisation of a light spot and a better perception of moving targets. Mobility and self-confidence improved. The main complications were conjunctival erosion due to the combined extra- and intraocular concept of the device. Among the 28 implanted systems, two needed to be removed because complications refractive to treatment. In contrast, EPIRET 3 is a fully intraocular epiretinal system. During a four week implantation, period thresholds were recorded and exhibited high variability between subjects. However, patients were able to recognise simple patterns. Epiretinal implants for electrical stimulation of the retina should be considered to treat advanced photoreceptor degeneration, and thus to restore basic visual functions at an acceptable rate of complications. Georg Thieme Verlag KG Stuttgart · New York.

  15. Biomedical implantable microelectronics.

    PubMed

    Meindl, J D

    1980-10-17

    Innovative applications of microelectronics in new biomedical implantable instruments offer a singular opportunity for advances in medical research and practice because of two salient factors: (i) beyond all other types of biomedical instruments, implants exploit fully the inherent technical advantages--complex functional capability, high reliability, lower power drain, small size and weight-of microelectronics, and (ii) implants bring microelectronics into intimate association with biological systems. The combination of these two factors enables otherwise impossible new experiments to be conducted and new paostheses developed that will improve the quality of human life.

  16. [Implantation of collagen coated hydroxyapatite particles. A clinical-histological study in humans].

    PubMed

    Sanz, M; Bascones, A; Kessler, A; García Nuñez, J; Newman, M G; Robertson, M A; Carranza, F A

    1989-05-01

    In this study, histologic behaviour of collagen coated hydroxylapatite particles implanted in human periodontal osseous defects has been analyzed. This material was surgically implanted in four patients, and reentry and block biopsies were carried out 4 and 6 months later. The histologic results demonstrate that this material is well tolerated by surrounding tissues, not eliciting an inflammatory reaction. At four months, the hydroxylapatite particles appear encapsulated by a very cellular connective tissue and at 6 months are found in direct contact with osteoid and mature bone. This material acts as a filler material, being fully biocompatible and stimulating an osseoconductive reaction of the adjacent alveolar bone.

  17. An algorithmic programming approach for back pain symptoms in failed back surgery syndrome using spinal cord stimulation with a multicolumn surgically implanted epidural lead: a multicenter international prospective study.

    PubMed

    Rigoard, Philippe; Jacques, Line; Delmotte, Alexandre; Poon, Katherine; Munson, Russell; Monlezun, Olivier; Roulaud, Manuel; Prevost, Audrey; Guetarni, Farid; Bataille, Benoit; Kumar, Krishna

    2015-03-01

    Many studies have demonstrated the efficacy and the medical/economic value of epidural spinal cord stimulation for the treatment of "failed back surgery syndrome" (FBSS). However, the back pain component of FBSS has been recalcitrant. Recent clinical trials have suggested that multicolumn surgically implanted leads combined with enhanced programming capabilities in the newer implantable pulse generators demonstrate the ability to treat the back pain component of FBSS. The objective of our present international multicentre study is to prospectively evaluate these findings in a larger population. We conducted a prospective, nonrandomized, observational study on 76 patients with refractory FBSS, consecutively implanted with multicolumn spinal cord stimulation (SCS) between 2008 and 2011 in three neurosurgical pain management centers (Poitiers, France; Montréal, Canada; and Regina, Canada). The primary objective of this study was to prospectively analyze the effect of multicolumn lead programming on paresthesia coverage for the back pain region in these patients. The secondary objective was to assess the analgesic efficacy of this technique on the global and back pain components. Paresthesia could be induced in the lower extremities in the majority of patients with at least one of the configurations tested. Bilateral low back paresthesia was induced in 53.5% of patients, while unilateral low back paresthesia was induced in 78.9% of patients. Multicolumn configurations were statistically more effective than monocolumn configurations for all anatomic regions studied. At 6 months, 75.4% of patients receiving multicolumn stimulation (n = 57) obtained at least a 30% improvement of the back pain VAS score, while 42.1% of patients obtained at least a 50% improvement of the back pain VAS score. This study confirms the hypothesis that multicolumn SCS should be considered as an important tool in the treatment of radicular and axial pain in FBSS patients. The efficacy of this

  18. [Pacemaker, implanted cardiac defibrillator and irradiation: Management proposal in 2010 depending on the type of cardiac stimulator and prognosis and location of cancer].

    PubMed

    Lambert, P; Da Costa, A; Marcy, P-Y; Kreps, S; Angellier, G; Marcié, S; Bondiau, P-Y; Briand-Amoros, C; Thariat, J

    2011-06-01

    Ionizing radiation may interfere with electric components of pacemakers or implantable cardioverter-defibrillators. The type, severity and extent of radiation damage to pacemakers, have previously been shown to depend on the total dose and dose rate. Over 300,000 new cancer cases are treated yearly in France, among which 60% are irradiated in the course of their disease. One among 400 of these patients has an implanted pacemaker or defibrillator. The incidence of pacemaker and implanted cardioverter defribillator increases in an ageing population. The oncologic prognosis must be weighted against the cardiologic prognosis in a multidisciplinary and transversal setting. Innovative irradiation techniques and technological sophistications of pacemakers and implantable cardioverter-defibrillators (with the introduction of more radiosensitive complementary metal-oxide-semiconductors since 1970) have potentially changed the tolerance profiles. This review of the literature studied the geometric, dosimetric and radiobiological characteristics of the radiation beams for high energy photons, stereotactic irradiation, protontherapy. Standardized protocols and radiotherapy optimization (particle, treatment fields, energy) are advisable in order to improve patient management during radiotherapy and prolonged monitoring is necessary following radiation therapy. The dose received at the pacemaker/heart should be calculated. The threshold for the cumulated dose to the pacemaker/implantable cardioverter-defibrillator (2 to 5 Gy depending on the brand), the necessity to remove/displace the device based on the dose-volume histogram on dosimetry, as well as the use of lead shielding and magnet are discussed.

  19. Cochlear Implants.

    ERIC Educational Resources Information Center

    Clark, Catherine; Scott, Larry

    This brochure explains what a cochlear implant is, lists the types of individuals with deafness who may be helped by a cochlear implant, describes the process of evaluating people for cochlear implants, discusses the surgical process for implanting the aid, traces the path of sound through the cochlear implant to the brain, notes the costs of…

  20. Cochlear Implants.

    ERIC Educational Resources Information Center

    Clark, Catherine; Scott, Larry

    This brochure explains what a cochlear implant is, lists the types of individuals with deafness who may be helped by a cochlear implant, describes the process of evaluating people for cochlear implants, discusses the surgical process for implanting the aid, traces the path of sound through the cochlear implant to the brain, notes the costs of…

  1. Dental implant management and maintenance: How to improve long-term implant success?

    PubMed

    Clark, Danielle; Levin, Liran

    2016-01-01

    Although dental implants are proven to be a predictable longterm treatment for patients, it is important to realize that not all implants that survive are necessarily successful. Successful implants are those that remain fully functional and healthy within the oral cavity. Peri-implantitis is a disease that is associated with implant failure, and is becoming rather prevalent. Assessing risk factors and stabilizing existing oral disease prior to the placement of implants will aid in preventing implant disease and failure. After implant placement, a strict follow-up regime with a dental professional should be implemented in order to monitor the implant and surrounding teeth for disease. The dental professional should continually encourage the patient to adhere to consistent homecare to prevent peri-implantitis from occurring, and in turn increase the success of their implants. Early diagnosis and elimination of inflammatory processes around the implants will improve the longterm prognosis as well.

  2. Effects of implantable peroneal nerve stimulation on gait quality, energy expenditure, participation and user satisfaction in patients with post-stroke drop foot using an ankle-foot orthosis.

    PubMed

    Schiemanck, Sven; Berenpas, Frank; van Swigchem, Roos; van den Munckhof, Pepijn; de Vries, Joost; Beelen, Anita; Nollet, Frans; Geurts, Alexander C

    2015-01-01

    To investigate whether an implantable functional electrical stimulation (FES) system of the common peroneal nerve (ActiGait®) improves relevant aspects of gait in chronic stroke patients with a drop foot typically using an ankle-foot orthosis (AFO). Ten community-dwelling patients participated, of whom eight patients could be analysed. Gait quality (kinematic, kinetic, and spatiotemporal characteristics) during a 10-meter comfortable walk test, normalised net energy expenditure during a 6-minute walk test, participation (physical activity and stroke impact) and user satisfaction were tested before implantation and at various moments after FES-system activation up to 26 weeks. Walking with FES yielded increased maximum paretic ankle plantarflexion (FES: -0.12; AFO: -4.79°, p <  0.01), higher paretic peak ankle power (FES: 1.46; AFO: 0.98 W/kg, p <  0.05) and better step length symmetry (FES: 14.90; AFO: 21.45% , p <  0.05). User satisfaction was higher for FES, but was unrelated to objective gait improvements. Energy expenditure and participation did not change. Implantable FES improved the use of residual ankle plantarflexion motion, ankle power of the paretic leg and step length symmetry compared to using an AFO, however, not resulting in decreased energy expenditure or improved participation. User satisfaction was highest with FES, but this was not related to the observed gait improvements.

  3. Penile Implants

    MedlinePlus

    Penile Implants Overview By Mayo Clinic Staff Penile implants are devices placed inside the penis to allow men with erectile dysfunction (ED) to get an erection. Penile implants are typically recommended after other treatments for ED ...

  4. Surgical therapy of neurogenic detrusor overactivity (hyperreflexia) in paraplegic patients by sacral deafferentation and implant driven micturition by sacral anterior root stimulation: methods, indications, results, complications, and future prospects.

    PubMed

    Kutzenberger, J

    2007-01-01

    Spinal cord injured patients with a suprasacral lesion usually develop a spastic bladder. The neurogenic detrusor overactivity (NDO) and the overactive external sphincter cause incontinence and threaten these patients with recurrent urinary tract infections (UTI), renal failure and autonomic dysreflexia. All of these severe disturbances may be well managed by sacral deafferentation (SDAF) and implantation of a sacral anterior root stimulator (SARS). Since September 1986 to December 2002, 464 paraplegic patients (220 females, 244 males) received a SDAF-SARS. The SDAF was done intradurally in almost all cases, which means that we used a single operation field to do a two-stages procedure (SDAF and SARS). The results include data on 440 patients with a mean follow-up of 8.6 years (18 months to 18 years) until December 2004. The complete deafferentation was successful in 95.2%. Of these patients, 420 paraplegics use the SARS for voiding, (frequency 4.7 per day) and 401 for defecation (frequency 4.7 per week). Continence was achieved in 364 patients (83%). UTIs decreased from 6.3 per year preoperatively to 1.2 per year postoperatively. Kidney function remained stable. Early complications were 6 CSF leaks and 5 implant infections. Late compli cations included receiver or cable failures and required surgical repair in 44 patients. A step-by-step program for trouble-shooting distinguishes implant failure from myogenic or neurogenic failure. SDAF is able to restore the reservoir function of urinary bladder and makes the patient achieve continence. Autonomic dysreflexia disappeared in most cases. By accurate adjustment of stimulation parameters, it is possible for the patient to have a low resistance micturition. The microsurgical technique requires intensive education. In addition, the therapist should be able to manage late complications.

  5. Dental Implants.

    PubMed

    Griggs, Jason A

    2017-10-01

    Systematic reviews of literature over the period between 2008 and 2017 are discussed regarding clinical evidence for the factors affecting survival and failure of dental implants. The factors addressed include publication bias, tooth location, insertion torque, collar design, implant-abutment connection design, implant length, implant width, bone augmentation, platform switching, surface roughness, implant coatings, and the use of ceramic materials in the implant body and abutment. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. [Cochlear implants].

    PubMed

    Lehnhardt, E; Battmer, R D; Nakahodo, K; Laszig, R

    1986-07-01

    Since the middle of 1984, the HNO-Klinik der Medizinischen Hochschule Hannover has provided deaf adults with a 22-channel cochlear implant (CI) device of Clark-NUCLEUS. The digital working system consists of an implantable stimulator/receiver and an externally worn speech processor. Energy and signals are transmitted transcutaneously via a transmitter coil. During the prevailing 26 operations (April 1986) the electrode array could be inserted at least 17 mm into the cochlea. The threshold and comfort levels of all patients were adjusted very quickly; the dynamic range usually grows during the first postoperative weeks. The individual rehabilitation results vary greatly, but all patients show a significant increase of vowel and consonant comprehension while using the speech processor and an improvement of words understood per minute in speech tracking from lip-reading alone to lip-reading with speech processor. Four months after surgery seven of 17 patients (group I) are able to understand on average 42.7 words per minute by speech tracking without lip-reading. Six patients (group II) recognise 69.2% of vowels and 42.5% of consonants by speech processor alone. Four patients (group III) can correctly repeat only vowels (52.3%) without lip-reading, but using the speech processor together with lip reading they have an improvement in consonant understanding of 37.9% and under freefield conditions they are able to understand up to 17.8% numbers of the Freiburg speech test.

  7. Implantable electrical device

    NASA Technical Reports Server (NTRS)

    Jhabvala, M. D. (Inventor)

    1982-01-01

    A fully implantable and self contained device is disclosed composed of a flexible electrode array for surrounding damaged nerves and a signal generator for driving the electrode array with periodic electrical impulses of nanoampere magnitude to induce regeneration of the damaged nerves.

  8. Pyk2 and Src-family protein-tyrosine kinases compensate for the loss of FAK in fibronectin-stimulated signaling events but Pyk2 does not fully function to enhance FAK- cell migration.

    PubMed Central

    Sieg, D J; Ilić, D; Jones, K C; Damsky, C H; Hunter, T; Schlaepfer, D D

    1998-01-01

    The focal adhesion kinase (FAK) protein-tyrosine kinase (PTK) links transmembrane integrin receptors to intracellular signaling pathways. We show that expression of the FAK-related PTK, Pyk2, is elevated in fibroblasts isolated from murine fak-/- embryos (FAK-) compared with cells from fak+/+ embryos (FAK+). Pyk2 was localized to perinuclear regions in both FAK+ and FAK- cells. Pyk2 tyrosine phosphorylation was enhanced by fibronectin (FN) stimulation of FAK- but not FAK+ cells. Increased Pyk2 tyrosine phosphorylation paralleled the time-course of Grb2 binding to Shc and activation of ERK2 in FAK- cells. Pyk2 in vitro autophosphorylation activity was not enhanced by FN plating of FAK- cells. However, Pyk2 associated with active Src-family PTKs after FN but not poly-L-lysine replating of the FAK- cells. Overexpression of both wild-type (WT) and kinase-inactive (Ala457), but not the autophosphorylation site mutant (Phe402) Pyk2, enhanced endogenous FN-stimulated c-Src in vitro kinase activity in FAK- cells, but only WT Pyk2 overexpression enhanced FN-stimulated activation of co-transfected ERK2. Interestingly, Pyk2 overexpression only weakly augmented FAK- cell migration to FN whereas transient FAK expression promoted FAK- cell migration to FN efficiently compared with FAK+ cells. Significantly, repression of endogenous Src-family PTK activity by p50(csk) overexpression inhibited FN-stimulated cell spreading, Pyk2 tyrosine phosphorylation, Grb2 binding to Shc, and ERK2 activation in the FAK- but not in FAK+ cells. These studies show that Pyk2 and Src-family PTKs combine to promote FN-stimulated signaling events to ERK2 in the absence of FAK, but that these signaling events are not sufficient to overcome the FAK- cell migration defects. PMID:9774338

  9. Fully Integrated Biochip Platforms for Advanced Healthcare

    PubMed Central

    Carrara, Sandro; Ghoreishizadeh, Sara; Olivo, Jacopo; Taurino, Irene; Baj-Rossi, Camilla; Cavallini, Andrea; de Beeck, Maaike Op; Dehollain, Catherine; Burleson, Wayne; Moussy, Francis Gabriel; Guiseppi-Elie, Anthony; De Micheli, Giovanni

    2012-01-01

    Recent advances in microelectronics and biosensors are enabling developments of innovative biochips for advanced healthcare by providing fully integrated platforms for continuous monitoring of a large set of human disease biomarkers. Continuous monitoring of several human metabolites can be addressed by using fully integrated and minimally invasive devices located in the sub-cutis, typically in the peritoneal region. This extends the techniques of continuous monitoring of glucose currently being pursued with diabetic patients. However, several issues have to be considered in order to succeed in developing fully integrated and minimally invasive implantable devices. These innovative devices require a high-degree of integration, minimal invasive surgery, long-term biocompatibility, security and privacy in data transmission, high reliability, high reproducibility, high specificity, low detection limit and high sensitivity. Recent advances in the field have already proposed possible solutions for several of these issues. The aim of the present paper is to present a broad spectrum of recent results and to propose future directions of development in order to obtain fully implantable systems for the continuous monitoring of the human metabolism in advanced healthcare applications. PMID:23112644

  10. Hypo-glycosylated Human Follicle-Stimulating Hormone (hFSH21/18) is much more active in vitro than Fully-glycosylated hFSH (hFSH24)

    PubMed Central

    Bousfield, George R.; Butnev, Vladimir Y.; Butnev, Viktor Y.; Hiromasa, Yasuaki; Harvey, David J.; May, Jeffrey V.

    2014-01-01

    Hypo-glycosylated hFSH21/18 (possesses FSHβ21 and FSH18 bands) was isolated from hLH preparations by immunoaffinity chromatography followed by gel filtration. Fully-glycosylated hFSH24 was prepared by combining the fully-glycosylated FSHβ24 variant with hCGα and isolating the heterodimer. The hFSH21/18 glycoform preparation was significantly smaller than the hFSH24 preparation and possessed 60% oligomannose glycans, which is unusual for hFSH. Hypo-glycosylated hFSH21/18 was 9- to 26-fold more active than fully-glycosylated hFSH24 in FSH radioligand assays. Significantly greater binding of 125I-hFSH21/18 tracer than hFSH24 tracer was observed in all competitive binding assays. In addition, higher binding of hFSH21/18 was noted in association and saturation binding assays, in which twice as much hFSH21/18 was bound as hFSH24. This suggests that more ligand binding sites are available to hFSH21/18 in FSHR than to hFSH24. Hypo-glycosylated hFSH21/18 also bound rat FSHRs more rapidly, exhibiting almost no lag in binding, whereas hFSH24 specific binding proceeded very slowly for almost the first hour of incubation. PMID:24291635

  11. Electrical stimulation of a small brain area reversibly disrupts consciousness.

    PubMed

    Koubeissi, Mohamad Z; Bartolomei, Fabrice; Beltagy, Abdelrahman; Picard, Fabienne

    2014-08-01

    The neural mechanisms that underlie consciousness are not fully understood. We describe a region in the human brain where electrical stimulation reproducibly disrupted consciousness. A 54-year-old woman with intractable epilepsy underwent depth electrode implantation and electrical stimulation mapping. The electrode whose stimulation disrupted consciousness was between the left claustrum and anterior-dorsal insula. Stimulation of electrodes within 5mm did not affect consciousness. We studied the interdependencies among depth recording signals as a function of time by nonlinear regression analysis (h(2) coefficient) during stimulations that altered consciousness and stimulations of the same electrode at lower current intensities that were asymptomatic. Stimulation of the claustral electrode reproducibly resulted in a complete arrest of volitional behavior, unresponsiveness, and amnesia without negative motor symptoms or mere aphasia. The disruption of consciousness did not outlast the stimulation and occurred without any epileptiform discharges. We found a significant inc