Long-term outcomes of sandwich ventral hernia repair paired with hybrid vacuum-assisted closure.

PubMed

Hicks, Caitlin W; Poruk, Katherine E; Baltodano, Pablo A; Soares, Kevin C; Azoury, Said C; Cooney, Carisa M; Cornell, Peter; Eckhauser, Frederic E

2016-08-01

Sandwich ventral hernia repair (SVHR) may reduce ventral hernia recurrence rates, although with an increased risk of surgical site occurrences (SSOs) and surgical site infections (SSIs). Previously, we found that a modified negative pressure wound therapy (hybrid vacuum-assisted closure [HVAC]) system reduced SSOs and SSIs after ventral hernia repair. We aimed to describe our outcomes after SVHR paired with HVAC closure. We conducted a 4-y retrospective review of all complex SVHRs (biologic mesh underlay and synthetic mesh overlay) with HVAC closure performed at our institution by a single surgeon. All patients had fascial defects that could not be reapproximated primarily using anterior component separation. Descriptive statistics were used to report the incidence of postoperative complications and hernia recurrence. A total of 60 patients (59.3 ± 11.4 y, 58.3% male, 75% American Society of Anesthesiologists class ≥3) with complex ventral hernias being underwent sandwich repair with HVAC closure. Major postoperative morbidity (Dindo-Clavien class ≥3) occurred in 14 (23.3%) patients, but incidence of SSO (n = 13, 21.7%) and SSI (n = 4, 6.7%) was low compared with historical reports. Median follow-up time for all patients was 12 mo (interquartile range 5.8-26.5 mo). Hernia recurrence occurred in eight patients (13.3%) after a median time of 20.6 months (interquartile range 16.4- 25.4 months). Use of a dual layer sandwich repair for complex abdominal wall reconstruction is associated with low rates of hernia recurrence at 1 year postoperatively. The addition of the HVAC closure system may reduce the risk of SSOs and SSIs previously reported with this technique and deserves consideration in future prospective studies assessing optimization of ventral hernia repair approaches. Copyright © 2016 Elsevier Inc. All rights reserved.

Window-assisted nanosphere lithography for vacuum micro-nano-electronics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Li, Nannan; Institute of Electronic Engineering, Chinese Academy of Engineering Physics, Mianyang, 621900; Pang, Shucai

2015-04-15

Development of vacuum micro-nano-electronics is quite important for combining the advantages of vacuum tubes and solid-state devices but limited by the prevailing fabricating techniques which are expensive, time consuming and low-throughput. In this work, window-assisted nanosphere lithography (NSL) technique was proposed and enabled the low-cost and high-efficiency fabrication of nanostructures for vacuum micro-nano-electronic devices, thus allowing potential applications in many areas. As a demonstration, we fabricated high-density field emitter arrays which can be used as cold cathodes in vacuum micro-nano-electronic devices by using the window-assisted NSL technique. The details of the fabricating process have been investigated. This work provided amore » new and feasible idea for fabricating nanostructure arrays for vacuum micro-nano-electronic devices, which would spawn the development of vacuum micro-nano-electronics.« less

Prospective cohort study of a new vacuum delivery device to assist with complicated labour in low-resource settings.

PubMed

Khan, Mishal; Hashmani, Farah Naz; Ahmed, Sajjad; Ahmed, Owais; Asim, Shabnam S; Wajahat, Yasmin; Sobani, Shoaib; Syed, Shershah; Qazi, Fahad

2015-02-01

Currently available vacuum devices used to assist women undergoing complicated labour are unsuitable for use in low-resource settings. The objective of this study was to evaluate the safety and feasibility of a new low-cost vacuum device, named Koohi Goth Vacuum Delivery System (KGVDS), designed for use in low-resource settings. A hospital-based, multicentre, prospective cohort study with no control group was conducted in Karachi, Pakistan. After training, KGVDS devices were made available for use by labour room staff at their discretion when instrumental delivery was indicated. Women to whom KGVDS was applied were followed from the start of labour until discharge. Feasibility was assessed in terms of successful expulsion of the foetal head following application of KGVDS and ease of use ratings. Safety was assessed by observing maternal and newborn post-delivery outcomes prior to discharge. Koohi Goth Vacuum Delivery System was applied to 137 women requiring instrumental delivery, of whom 111 (81%; 95% CI = 74-88%) successfully expelled the foetal head assisted by KGVDS and 103 (75%) stated that they would agree to use KGVDS again. There were no serious maternal or neonatal injuries or infections related to KGVDS use. The mean score for 'ease of use' given by doctors and midwives using the device was 8 of 10. Koohi Goth Vacuum Delivery System was feasible and safe to use for assisting complicated deliveries in low-resource hospitals in this initial evaluation. Our results indicate that this new device may have the potential to improve birth outcomes in settings where most mortality occurs and that further evaluations should be conducted. © 2014 John Wiley & Sons Ltd.

Vacuum-Assisted, Constant-Force Exercise Device

NASA Technical Reports Server (NTRS)

Hansen, Christopher P.; Jensen, Scott

2006-01-01

The vacuum-assisted, constant-force exercise device (VAC-FED) has been proposed to fill a need for a safe, reliable exercise machine that would provide constant loads that could range from 20 to 250 lb (0.09 to 1.12 kN) with strokes that could range from 6 to 36 in. (0.15 to 0.91 m). The VAC-FED was originally intended to enable astronauts in microgravity to simulate the lifting of free weights, but it could just as well be used on Earth for simulated weight lifting and other constant-force exercises. Because the VAC-FED would utilize atmospheric/vacuum differential pressure instead of weights to generate force, it could weigh considerably less than either a set of free weights or a typical conventional exercise machine based on weights. Also, the use of atmospheric/ vacuum differential pressure to generate force would render the VAC-FED inherently safer, relative to free weights and to conventional exercise machines that utilize springs to generate forces. The overall function of the VAC-FED would be to generate a constant tensile force in an output cable, which would be attached to a bar, handle, or other exercise interface. The primary force generator in the VAC-FED would be a piston in a cylinder. The piston would separate a volume vented to atmosphere at one end of the cylinder from an evacuated volume at the other end of the cylinder (see figure). Hence, neglecting friction at the piston seals, the force generated would be nearly constant equal to the area of the piston multiplied by the atmospheric/vacuum differential pressure. In the vented volume in the cylinder, a direct-force cable would be looped around a pulley on the piston, doubling the stroke and halving the tension. One end of the direct-force cable would be anchored to a cylinder cap; the other end of the direct-force cable would be wrapped around a variable-ratio pulley that would couple tension to the output cable. As its name suggests, the variable-ratio pulley would contain a mechanism that

A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device.

PubMed

Dorafshar, Amir H; Franczyk, Mieczyslawa; Gottlieb, Lawrence J; Wroblewski, Kristen E; Lohman, Robert F

2012-07-01

Two methods of subatmospheric pressure wound therapy--wall suction applied to a sealed gauze dressing (GSUC) and the vacuum-assisted closure device (VAC)--were compared in hospitalized patients at University of Chicago Medical Center. VAC therapy is widely used, but can be expensive and difficult to apply; it also fails in some patients. A randomized prospective study of 87 patients (N = 45 in the GSUC arm and N = 42 in the VAC arm) was undertaken between October 2006 and May 2008. The study comprised patients with acute wounds resulting from trauma, dehiscence, or surgery. Demographics and wound characteristics were similar in both groups. There were significant reductions in wound surface area and volume in each group. In the GSUC group, the reductions in wound surface area and volume were 4.5%/day and 8.4%/day, respectively (P < 0.001 for both), and in the VAC group, this was 4.9%/day and 9.8%/day, respectively (P < 0.001 for both). The reductions in wound surface area and volume were similar in both groups (P = 0.60 and 0.19, respectively, for the group-by-time interaction). The estimated difference (VAC - GSUC) was 0.4% (95% confidence interval: -1.0, 1.7) for wound surface area and 1.4% (95% confidence interval: -0.7, 3.5) for volume. The mean cost per day for GSUC therapy was $4.22 versus $96.51 for VAC therapy (P < 0.01) and the average time required for a GSUC dressing change was 19 minutes versus 31 minutes for a VAC dressing change (P < 0.01). The sum of pain intensity differences was 0.50 in the GSUC group compared with 1.73 for the VAC group (P = 0.02). GSUC is noninferior to VAC with respect to changes in wound volume and surface area in an acute care setting. In addition, GSUC dressings were easier to apply, less expensive, and less painful.

Open abdomen with vacuum-assisted wound closure and mesh-mediated fascial traction in patients with complicated diffuse secondary peritonitis: A single-center 8-year experience.

PubMed

Tolonen, Matti; Mentula, Panu; Sallinen, Ville; Rasilainen, Suvi; Bäcklund, Minna; Leppäniemi, Ari

2017-06-01

Open abdomen (OA) treatment in patients with peritonitis is increasing worldwide. Various temporary abdominal closure devices are being used. This study included patients with complicated diffuse secondary peritonitis, OA, and vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM). The aim of this study was to describe mortality and major morbidity in terms of delayed primary fascial closure and enteroatmospheric fistula rates. This was a single-academic-center retrospective study of consecutive patients with diffuse peritonitis, OA, and VAWCM between years 2008 and 2016. Descriptive and univariate analyses were performed. Forty-one patients were identified and analyzed. Median age was 59 years, preoperative septic shock was diagnosed in 54% (n = 22), and 59% (n = 24) had a postoperative peritonitis. Mortality was 29% (n = 12), and 76% (n = 31) of patients were admitted in the intensive care unit. The median duration of OA was 7 days with a median of two dressing changes. Delayed primary fascial closure rate among survivors was 92% (n = 33), and enteroatmospheric fistulas developed in 7% (n = 3). In a subgroup analysis, patients with OA in the primary laparotomy for peritonitis (n = 27) were compared with patients with OA in the subsequent laparotomies (n = 14). There were no significant differences between groups. The VAWCM technique in patients with complicated secondary diffuse peritonitis and OA yields excellent results in terms of delayed primary fascial closure rate and a low number of enteroatmospheric fistulas. It seems to be safe to close the abdomen at the index laparotomy, if possible, even if there is a risk of a need of OA later. Therapeutic/care management study, level IV.

Remote controlled vacuum joint closure mechanism

DOEpatents

Doll, D.W.; Hager, E.R.

1984-02-22

A remotely operable and maintainable vacuum joint closure mechanism for a noncircular aperture is disclosed. The closure mechanism includes an extendible bellows coupled at one end to a noncircular duct and at its other end to a flange assembly having sealed grooves for establishing a high vacuum seal with the abutting surface of a facing flange which includes an aperture forming part of the system to be evacuated. A plurality of generally linear arrangements of pivotally coupled linkages and piston combinations are mounted around the outer surface of the duct and aligned along the length thereof. Each of the piston/linkage assemblies is adapted to engage the flange assembly by means of a respective piston and is further coupled to a remote controlled piston drive shaft to permit each of the linkages positioned on a respective flat outer surface of the duct to simultaneously and uniformly displace a corresponding piston and the flange assembly with which it is in contact along the length of the duct in extending the bellows to provide a high vacuum seal between the movable flange and the facing flange. A plurality of latch mechanisms are also pivotally mounted on the outside of the duct. A first end of each of the latch mechanisms is coupled to a remotely controlled latch control shaft for displacing the latch mechanism about its pivot point. In response to the pivoting displacement of the latch mechanism, a second end thereof is displaced so as to securely engage the facing flange and maintain the high vacuum seal established by the displacement of the flange assembly and extension of the bellows without displacing the entire duct.

Effect of vacuum-assisted closure combined with open bone grafting to promote rabbit bone graft vascularization.

PubMed

Hu, Chao; Zhang, Taogen; Ren, Bin; Deng, Zhouming; Cai, Lin; Lei, Jun; Ping, Ansong

2015-04-27

Patients with composite bone non-union and soft tissue defects are difficult to treat. Vacuum-assisted closure (VAC) combined with open bone grafting is one of the most effective treatments at present. The aim of the present study was to preliminarily investigate the effect and mechanism of VAC combined with open bone grafting to promote rabbit bone graft vascularization, and to propose a theoretical basis for clinical work. Twenty-four New Zealand white rabbits were randomly divided into an experimental and a control group. Allogeneic bones were grafted and banded with the proximal femur with a suture. The experimental group had VAC whereas the control group had normal wound closure. The bone vascularization rate was compared based on X-ray imaging, fluorescent bone labeling (labeled tetracycline hydrochloride and calcein), calcium content in the callus, and expression of fibroblast growth factor-2 (FGF-2) in bone allografts by Western blot analysis at the 4th, 8th, and 12th week after surgery. At the 4th, 8th, and 12th week after surgery, the results of the tests demonstrated that the callus was larger, contained more calcium (p<0.05), and expressed FGF-2 at higher levels (p<0.05) in the experimental group than in the control group. Fluorescent bone labeling showed the distance between the two fluorescent ribbons was significantly shorter in the control group than in the experimental group at the 8th and 12th week after surgery. VAC combined with open bone grafting promoted rabbit bone graft vascularization.

Abdominal Subcutaneous Mass After Laser-Assisted Lipolysis and Immediate Multiple Treatments with a Dual-Wavelength Laser, Vacuum and Massage Device.

PubMed

Gentileschi, Stefano; Servillo, Maria; D'Ettorre, Marco; Salgarello, Marzia

2016-04-01

Body contouring by means of minimally invasive procedures is a growing trend. Current approaches to body contouring often involve a combination of surgical techniques (eg, laser-assisted liposuction) and a series of noninvasive device-based treatments aimed at accelerating recovery and improving aesthetic outcomes. In this case study, we describe a 38-year-old woman who presented with an abdominal-wall mass that resembled a tumor when assessed with magnetic resonance imaging. Twenty-six months before presenting to our office, the patient had undergone laser lipolysis and a series of treatments with a device that delivered dual-wavelength laser energy and vacuum-assisted massage. To address the patient's concerns, we removed the mass and performed abdominal dermolipectomy. No postoperative complications occurred, and the patient was highly satisfied with the aesthetic outcome. The results of histologic studies indicated that the mass was pseudocystic and fluid-filled, surrounded by a fibrous capsule, and characterized as a foreign-body granuloma. Further analysis is warranted regarding the safety of laser lipolysis without aspiration combined with a device delivering dual-wavelength laser energy and vacuum-assisted massage. 5 Risk. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Emergent Embolization of Arterial Bleeding after Vacuum-Assisted Breast Biopsy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fischman, Aaron M., E-mail: aaron.fischman@mountsinai.org; Epelboym, Yan, E-mail: yan.epelboym@mssm.edu; Siegelbaum, Robert H., E-mail: rhsiegelbaum@gmail.com

2012-02-15

Vacuum-assisted core breast biopsy has become important in evaluating patients with suspicious breast lesions. It has proven to be a relatively safe procedure that in rare cases can result in vascular complications. These are the first reported cases of transcatheter embolization of uncontrolled breast hemorrhage after vacuum-assisted breast biopsy. With increased use of biopsy and larger-gauge devices, breast imaging groups may consider embolotherapy as a safe alternative for treatment of hemorrhage in a select group of patients.

Goose-neck snare-assisted transcatheter ASD closure: A safety procedure for large and complex ASDs.

PubMed

Butera, Gianfranco; Lovin, Nicusor; Basile, Domenica Paola; Carminati, Mario

2016-04-01

To report on a new technique that increases the safety of percutaneous atrial septal defect (ASD) closure using a goose-neck snare system. ASD transcatheter closure is a widespread procedure. However, in some cases, ASDs may be large and with soft rims. In these situation, a potential risk exists for device malposition or embolization. When transesophageal echocardiography (TEE) evaluation and balloon sizing showed large defects with floppy rims the chosen Amplatzer device was implanted in a standard way. In large defects with floppy rims, before release a 5-mm goose-neck snare with its 4 Fr catheter was placed across the delivery cable and fixed to catch the screwing mechanism of implanted Amplatzer device. The delivery cable was unscrewed and the device reached its final position without any tension. If the position was considered satisfactory the device was released from the goose-neck snare. Thirteen patients had a snare-assisted ASD transcatheter closure. Median device size was 24 mm (range 14-38 mm). Retrieval or repositioning of the device using the goose-neck snare was performed in four cases: in three patients, because of device malposition after delivery cable release and in one patient, because of unsuitability of closure of a second significant defect. Furthermore, in two subjects with multiple ASDs, a second fenestration looked quite significant with the device still attached to the delivery cable while it appeared smaller after release. Snare-assisted Amplatzer ASD device placement is a new method for ASD percutaneous closure and adds safety to the procedure. © 2016 Wiley Periodicals, Inc.

Remote controlled vacuum joint closure mechanism

DOEpatents

Doll, David W.; Hager, E. Randolph

1986-01-01

A remotely operable and maintainable vacuum joint closure mechanism for a noncircular aperture is disclosed. The closure mechanism includes an extendible bellows coupled at one end to a noncircular duct and at its other end to a flange assembly having sealed grooves for establishing a high vacuum seal with the abutting surface of a facing flange which includes an aperture forming part of the system to be evacuated. A plurality of generally linear arrangements of pivotally coupled linkages and piston combinations are mounted around the outer surface of the duct and aligned along the length thereof. Each of the piston/linkage assemblies is adapted to engage the flange assembly by means of a respective piston and is further coupled to a remote controlled piston drive shaft to permit each of the linkages positioned on a respective flat outer surface of the duct to simultaneously and uniformly displace a corresponding piston and the flange assembly with which it is in contact along the length of the duct in extending the bellows to provide a high vacuum seal between the movable flange and the facing flange. A plurality of latch mechanisms are also pivotally mounted on the outside of the duct. A first end of each of the latch mechanisms is coupled to a remotely controlled latch control shaft for displacing the latch mechanism about its pivot point. In response to the pivoting displacement of the latch mechanism, a second end thereof is displaced so as to securely engage the facing flange.

49 CFR 570.56 - Vacuum brake assist unit and vacuum brake system.

Code of Federal Regulations, 2010 CFR

2010-10-01

.... The following requirements apply to vehicles with vacuum brake assist units and vacuum brake systems. (a) Vacuum brake assist unit integrity. The vacuum brake assist unit shall demonstrate integrity as... maintained on the pedal. (1) Inspection procedure. Stop the engine and apply service brake several times to...

Options for Closure of the Infected Abdomen

PubMed Central

Campbell, Chris A.; Rosenberger, Laura H.; Politano, Amani D.; Davies, Stephen W.; Riccio, Lin M.; Sawyer, Robert G.

2012-01-01

Abstract Background The infected abdomen poses substantial challenges to surgeons, and often, both temporary and definitive closure techniques are required. We reviewed the options available to close the abdominal wall defect encountered frequently during and after the management of complicated intra-abdominal infections. Methods A comprehensive review was performed of the techniques and literature on abdominal closure in the setting of intra-abdominal infection. Results Temporary abdominal closure options include the Wittmann Patch, Bogota bag, vacuum-assisted closure (VAC), the AbThera™ device, and synthetic or biologic mesh. Definitive reconstruction has been described with mesh, components separation, and autologous tissue transfer. Conclusion Reconstructing the infected abdomen, both temporarily and definitively, can be accomplished with various techniques, each of which is associated with unique advantages and disadvantages. Appropriate judgment is required to optimize surgical outcomes in these complex cases. PMID:23216525

A novel vacuum assisted closure therapy model for use with percutaneous devices.

PubMed

Cook, Saranne J; Nichols, Francesca R; Brunker, Lucille B; Bachus, Kent N

2014-06-01

Long-term maintenance of a dermal barrier around a percutaneous prosthetic device remains a common clinical problem. A technique known as Negative Pressure Wound Therapy (NPWT) uses negative pressure to facilitate healing of impaired and complex soft tissue wounds. However, the combination of using negative pressure with percutaneous prosthetic devices has not been investigated. The goal of this study was to develop a methodology to apply negative pressure to the tissues surrounding a percutaneous device in an animal model; no tissue healing outcomes are presented. Specifically, four hairless rats received percutaneous porous coated titanium devices implanted on the dorsum and were bandaged with a semi occlusive film dressing. Two of these animals received NPWT; two animals received no NPWT and served as baseline controls. Over a 28-day period, both the number of dressing changes required between the two groups as well as the pressures were monitored. Negative pressures were successfully applied to the periprosthetic tissues in a clinically relevant range with a manageable number of dressing changes. This study provides a method for establishing, maintaining, and quantifying controlled negative pressures to the tissues surrounding percutaneous devices using a small animal model. Published by Elsevier Ltd.

CIRSE Vascular Closure Device Registry

DOE Office of Scientific and Technical Information (OSTI.GOV)

Reekers, Jim A., E-mail: j.a.reekers@amc.uva.nl; Mueller-Huelsbeck, Stefan; Libicher, Martin

2011-02-15

Purpose: Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods: The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results: Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0-14.5] for antegrade access and 1.8% (95% CI 1.1-2.9) for retrograde access (Pmore » = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only <0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma >5.9 cm, and two vessel occlusions. Conclusion: The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters.« less

CIRSE Vascular Closure Device Registry

PubMed Central

Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2010-01-01

Purpose Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0–14.5] for antegrade access and 1.8% (95% CI 1.1–2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only <0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma >5.9 cm, and two vessel occlusions. Conclusion The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters. PMID:20981425

A clinical review of infected wound treatment with Vacuum Assisted Closure (V.A.C.) therapy: experience and case series.

PubMed

Gabriel, Allen; Shores, Jaimie; Bernstein, Brent; de Leon, Jean; Kamepalli, Ravi; Wolvos, Tom; Baharestani, Mona M; Gupta, Subhas

2009-10-01

Over the last decade Vacuum Assisted Closure((R)) (KCI Licensing, Inc., San Antonio, TX) has been established as an effective wound care modality for managing complex acute and chronic wounds. The therapy has been widely adopted by many institutions to treat a variety of wound types. Increasingly, the therapy is being used to manage infected and critically colonized, difficult-to-treat wounds. This growing interest coupled with practitioner uncertainty in using the therapy in the presence of infection prompted the convening of an interprofessional expert advisory panel to determine appropriate use of the different modalities of negative pressure wound therapy (NPWT) as delivered by V.A.C.((R)) Therapy and V.A.C. Instill((R)) with either GranuFoam() or GranuFoam Silver() Dressings. The panel reviewed infected wound treatment methods within the context of evidence-based medicine coupled with experiential insight using V.A.C.((R)) Therapy Systems to manage a variety of infected wounds. The primary objectives of the panel were 1) to exchange state-of-practice evidence, 2) to review and evaluate the strength of existing data, and 3) to develop practice recommendations based on published evidence and clinical experience regarding use of the V.A.C.((R)) Therapy Systems in infected wounds. These recommendations are meant to identify which infected wounds will benefit from the most appropriate V.A.C.((R)) Therapy System modality and provide an infected wound treatment algorithm that may lead to a better understanding of optimal treatment strategies.

Vacuum-assisted venous return reduces blood usage.

PubMed

Banbury, Michael K; White, Jennifer A; Blackstone, Eugene H; Cosgrove, Delos M

2003-09-01

To determine whether vacuum-assisted venous return has clinical advantages over conventional gravity drainage apart from allowing the use of smaller cannulas and shorter tubing. A total of 150 valve operations were performed at our institution between February and July 1999 using vacuum-assisted venous return with small venous cannulas connected to short tubing. These were compared with (1) 83 valve operations performed between April 1997 and January 1998 using the initial version of vacuum-assisted venous return, and (2) 124 valve operations performed between January and April of 1997 using conventional gravity drainage. Priming volume, hematocrit value, red blood cell usage, and total blood product usage were compared multivariably. These comparisons were covariate and propensity adjusted for dissimilarities between the groups and confirmed by propensity-matched pairs analysis. Priming volume was 1.4 +/- 0.4 L for small-cannula vacuum-assisted venous return, 1.7 +/- 0.4 L for initial vacuum-assisted venous return, and 2.0 +/- 0.4 L for gravity drainage (P <.0001). Smaller priming resulted in higher hematocrit values both at the beginning of cardiopulmonary bypass (27% +/- 5% compared with 26% +/- 4% and 25% +/- 4%, respectively, P <.0001) and at the end (30% +/- 4% compared with 28% +/- 4% and 27% +/- 4%, respectively, P <.0001). Red cell transfusions were used in 17% of the patients having small-cannula vacuum-assisted venous return, 27% of the initial patients having vacuum-assisted venous return, and 37% of the patients having gravity drainage (P =.001); total blood product usage was 19%, 27%, and 39%, respectively (P =.002). Although ministernotomy also was associated with reduced blood product usage (P <.004), propensity matching on type of sternotomy confirmed the association of vacuum-assisted venous return with lowered blood product usage. Vacuum-assisted venous return results in (1) higher hematocrit values during cardiopulmonary bypass and (2) decreased

Perventricular double-device closure of wide-spaced multi-hole perimembranous ventricular septal defect.

PubMed

Liang, Fei; Hongxin, Li; Zhang, Hai-Zhou; Wenbin, Guo; Zou, Cheng-Wei; Farhaj, Zeeshan

2017-04-17

Device closure of a wide-spaced multi-hole PmVSD is difficult to succeed in percutaneous approach. This study is to evaluate the feasibility, safety and efficacy of perventricular device closure of wide-spaced multi-hole PmVSD using a double-device implanting technique. Sixteen patients with wide-spaced multi-hole PmVSD underwent perventricular closure with two devices through an inferior median sternotomy approach under transesophageal echocardiographic guidance. The largest hole and its adjacent small holes were occluded with an optimal-sized device. The far-away residual hole was occluded with the other device using a probe-assisted delivery system. All patients were followed up for a period of 1 to 4 years to determine the residual shunt, atrioventricular block and the adjacent valvular function. The number of the holes of the PmVSD was 2 to 4. The maximum distance between the holes was 5.0 to 10.0 mm (median, 6.4 mm). The diameter of the largest hole was 2.5 to 7.0 mm (median, 3.6 mm). The success rate of double-device closure was 100%. Immediate residual shunts were found in 6 patients (38%), and incomplete right bundle branch block at discharge occurred in 3 cases (19%). Both complications decreased to 6% at 1-year follow-up. Neither of them had a severe device-related complication. Perventricular closure of a wide-spaced multi-hole PmVSD using a double-device implanting technique is feasible, safe, and efficacious. In multi-hole PmVSDs with the distance between the holes of more than 5 mm, double-device implantation may achieve a complete occlusion.

Economic evaluation of Vacuum Assisted Closure® Therapy for the treatment of diabetic foot ulcers in France.

PubMed

Whitehead, Sarah J; Forest-Bendien, Véronique L; Richard, Jean-Louis; Halimi, Serge; Van, Georges Ha; Trueman, Paul

2011-02-01

The objective of the study was to assess the cost-effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy compared with advanced wound care (AWC) for the treatment of diabetic foot ulcers (DFUs) in France. A cost-effectiveness model intended to reflect the management of DFUs was updated for the French setting. The Markov model follows the progression of 1000 hypothetical patients over a 1-year period. The model was populated with French-specific data, obtained from published sources and clinical experts. The analysis evaluated costs and health outcomes, in terms of quality-adjusted life-years (QALYs), wounds healed and amputations, from the perspective of the payer. The patients treated with V.A.C.® Therapy experienced more QALYs (0.787 versus 0.784) and improved healing rates (50.2% versus 48.5%) at a lower total cost of care (€24,881 versus €28,855 per patient per year) when compared with AWC. Sensitivity analyses conducted around key model parameters indicated that the results were affected by hospital resource use and costs. DFU treatment using V.A.C.® Therapy in France was associated with lower costs, additional QALYs, more healed ulcers and fewer amputations than treatment with AWC. V.A.C.® Therapy was therefore found to be the dominant treatment option. © 2010 The Authors. © 2010 Blackwell Publishing Ltd and Medicalhelplines.com Inc.

Skin graft secured by VAC (vacuum-assisted closure) therapy in chronic leg ulcers: A controlled randomized study.

PubMed

Leclercq, A; Labeille, B; Perrot, J-L; Vercherin, P; Cambazard, F

2016-01-01

Leg ulcers are a common condition. There have been very few studies of combined therapy involving VAC (vacuum-assisted closure) and skin graft. We performed a randomized controlled trial of VAC therapy vs. hydrocolloid dressings over 5 days following autologous grafting on chronic leg ulcers. The primary objective was to assess the difference in success (defined as a reduction in wound area of at least 50% at 1 month) between the two dressing methods. Forty-six patients with ulcers present for over one month were included. Following a 7-day hospitalization period, follow-up was performed for 3 months on an outpatient basis. Our study does not demonstrate a statistically significant difference, with a 45.8% success rate in the VAC group vs. 40.9% in the conventional dressing group (P=0.73). In the venous ulcer group, the success rate was 57.9% for VAC vs. 40% for conventional dressings (P=0.3). The difference in favor of VAC in this group was not statistically significant, most likely due to an insufficient number of patients studied. Our study does not demonstrate superiority of VAC associated with skin graft over conventional dressings. We observed more complications with VAC (40%) than with conventional dressings (23%) (P=0.06). Copyright © 2015 Elsevier Masson SAS. All rights reserved.

The Effect of Vacuum-Assisted Closure on the Bacterial Load and Type of Bacteria: A Systematic Review

PubMed Central

Patmo, Aryan S.P.; Krijnen, Pieta; Tuinebreijer, Wim E.; Breederveld, Roelf S.

2014-01-01

Significance: A high bacterial load interferes with the healing process of a wound. Vacuum-assisted closure (VAC) is a wound healing therapy that utilizes a dressing system that continuously or intermittently applies a negative pressure to the wound surface. Recent Advances: VAC stimulates wound healing, but data on changes in the bacterial load and changes in the bacterial spectrum are scarce. Critical Issues: While VAC supposedly removes bacteria from the treated wounds and therefore reduces the risk of infection, this relationship has not yet been clinically proven. If VAC increases the bacterial load instead of decreasing it, then this may be a reason not to use VAC on certain types of wounds. Only seven small and heterogeneous studies reporting on the relationship between VAC usage and the bacterial load and type of bacteria in the treated wounds in clinical practice were found in the literature. Although there is some low quality evidence that VAC therapy does not change the bacterial load, no definite conclusions on changes in the bacterial load and type of bacteria during VAC can be drawn. Future Directions: Prospectively monitoring changes in the bacterial load and bacterial spectrum in patients that will receive VAC treatment on indication might be an effective way to find out whether it should indeed be used on specific wounds. PMID:24804158

Vacuum-assisted closure therapy increases local interleukin-8 and vascular endothelial growth factor levels in traumatic wounds.

PubMed

Labler, Ludwig; Rancan, Mario; Mica, Ladislav; Härter, Luc; Mihic-Probst, Daniela; Keel, Marius

2009-03-01

Clinical observations are suggesting accelerated granulation tissue formation in traumatic wounds treated with vacuum-assisted closure (VAC). Aim of this study was to determine the impact of VAC therapy versus alternative Epigard application on local inflammation and neovascularization in traumatic soft tissue wounds. Thirty-two patients with traumatic wounds requiring temporary coverage (VAC n = 16; Epigard n = 16) were included. At each change of dressing, samples of wound fluid and serum were collected (n = 80). The cytokines interleukin (IL)-6, IL-8, vascular endothelial growth factor (VEGF), and fibroblast growth factor-2 were measured by ELISA. Wound biopsies were examined histologically for inflammatory cells and degree of neovascularization present. All cytokines were found to be elevated in wound fluids during both VAC and Epigard treatment, whereas serum concentrations were negligible or not detectable. In wound fluids, significantly higher IL-8 (p < 0.001) and VEGF (p < 0.05) levels were detected during VAC therapy. Furthermore, histologic examination revealed increased neovascularization (p < 0.05) illustrated by CD31 and von Willebrand factor immunohistochemistry in wound biopsies of VAC treatment. In addition, there was an accumulation of neutrophils as well as an augmented expression of VEGF (p < 0.005) in VAC wound biopsies. This study suggests that VAC therapy of traumatic wounds leads to increased local IL-8 and VEGF concentrations, which may trigger accumulation of neutrophils and angiogenesis and thus, accelerate neovascularization.

Fast MRI-guided vacuum-assisted breast biopsy: initial experience.

PubMed

Liberman, Laura; Morris, Elizabeth A; Dershaw, D David; Thornton, Cynthia M; Van Zee, Kimberly J; Tan, Lee K

2003-11-01

The purpose of this study was to evaluate a new method for performing MRI-guided vacuum-assisted breast biopsy in a study of lesions that had subsequent surgical excision. SUBJECTS AND METHODS. Twenty women scheduled for MRI-guided needle localization and surgical biopsy were prospectively entered in the study. MRI-guided biopsy was performed with a vacuum-assisted probe, followed by placement of a localizing clip, and then needle localization for surgical excision. Vacuum-assisted biopsy and surgical histology were correlated. Vacuum-assisted biopsy was successfully performed in 19 (95%) of the 20 women. The median size of 27 MRI-detected lesions that had biopsy was 1.0 cm (range, 0.4-6.4 cm). Cancer was present in eight (30%) of 27 lesions and in six (32%) of 19 women; among these eight cancers, five were infiltrating and three were ductal carcinoma in situ (DCIS). Among these 27 lesions, histology was benign at vacuum-assisted biopsy and at surgery in 19 (70%), cancer at vacuum-assisted biopsy in six (22%), atypical ductal hyperplasia at vacuum-assisted biopsy and DCIS at surgery in one (4%), and benign at vacuum-assisted biopsy with surgery showing microscopic DCIS that was occult at MRI in one (4%). The median time to perform vacuum-assisted biopsy of a single lesion was 35 min (mean, 35 min; range, 24-48 min). Placement of a localizing clip, attempted in 26 lesions, was successful in 25 (96%) of 26, and the clip was retrieved on specimen radiography in 22 (96%) of 23. One complication occurred: a hematoma that resolved with compression. MRI-guided vacuum-assisted biopsy is a fast, safe, and accurate alternative to surgical biopsy for breast lesions detected on MRI.

Suitability of Exoseal Vascular Closure Device for Antegrade Femoral Artery Puncture Site Closure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schmelter, Christopher, E-mail: christopher.schmelter@klinikum-ingolstadt.de; Liebl, Andrea; Poullos, Nektarios

Purpose. To assess the efficacy and safety of the Exoseal vascular closure device for antegrade puncture of the femoral artery. Methods. In a prospective study from February 2011 to January 2012, a total of 93 consecutive patients received a total of 100 interventional procedures via an antegrade puncture of the femoral artery. An Exoseal vascular closure device (6F) was used for closure in all cases. Puncture technique, duration of manual compression, and use of compression bandages were documented. All patients were monitored by vascular ultrasound and color-coded duplex sonography of their respective femoral artery puncture site within 12 to 36more » h after angiography to check for vascular complications. Results. In 100 antegrade interventional procedures, the Exoseal vascular closure device was applied successfully for closure of the femoral artery puncture site in 96 cases (96 of 100, 96.0 %). The vascular closure device could not be deployed in one case as a result of kinking of the vascular sheath introducer and in three cases because the bioabsorbable plug was not properly delivered to the extravascular space adjacent to the arterial puncture site, but instead fully removed with the delivery system (4.0 %). Twelve to 36 h after the procedure, vascular ultrasound revealed no complications at the femoral artery puncture site in 93 cases (93.0 %). Minor vascular complications were found in seven cases (7.0 %), with four cases (4.0 %) of pseudoaneurysm and three cases (3.0 %) of significant late bleeding, none of which required surgery. Conclusion. The Exoseal vascular closure device was safely used for antegrade puncture of the femoral artery, with a high rate of procedural success (96.0 %), a low rate of minor vascular complications (7.0 %), and no major adverse events.« less

Echocardiographic predictors of coil vs device closure in patients undergoing percutaneous patent ductus arteriosus closure.

PubMed

Roushdy, Alaa; Abd El Razek, Yasmeen; Mamdouh Tawfik, Ahmed

2018-01-01

To determine anatomic and hemodynamic echocardiographic predictors for patent ductus arteriosus (PDA) device vs coil closure. Seventy-six patients who were referred for elective transcatheter PDA closure were enrolled in the study. All patients underwent full echocardiogram including measurement of the PDA pulmonary end diameter, color flow width and extent, peak and end-diastolic Doppler gradients across the duct, diastolic flow reversal, left atrial dimensions and volume, left ventricular sphericity index, and volumes. The study group was subdivided into 2 subgroups based on the mode of PDA closure whether by coil (n = 42) or device (n = 34). Using univariate analysis there was a highly significant difference between the 2 groups as regard the pulmonary end diameter measured in both the suprasternal and parasternal short-axis views as well as the color flow width and color flow extent (P < .0001). The device closure group had statistically significant higher end-systolic and end-diastolic volumes indexed, left atrial volume, and diastolic flow reversal. Receiver operating characteristic curve analysis showed a pulmonary end diameter cutoff point from the suprasternal view > 2.5 mm and from parasternal short-axis view > 2.61 mm to have the highest balanced sensitivity and specificity to predict the likelihood for device closure (AUC 0.971 and 0.979 respectively). The pulmonary end diameter measured from the suprasternal view was the most independent predictor of device closure. The selection between PDA coil or device closure can be done on the basis of multiple anatomic and hemodynamic echocardiographic variables. © 2017 Wiley Periodicals, Inc.

Patent ductus arteriosus closure using an Amplatzer™ ventricular septal defect closure device

PubMed Central

Fernando, Rajeev; Koranne, Ketan; Loyalka, Pranav; Kar, Biswajit; Gregoric, Igor

2013-01-01

The ductus arteriosus originates from the persistence of the distal portion of the left sixth aortic arch. It connects the descending aorta (immediately distal to the left subclavian artery) to the roof of the main pulmonary artery, near the origin of the left pulmonary artery. Persistence of the duct beyond 48 h after birth is abnormal and results in patent ductus arteriosus (PDA). PDA is rare in adults because it is usually discovered and treated in childhood. Mechanical closure remains the definitive therapy because the patency of ductus arteriosus may lead to multiple complications, depending on the size and flow through the ductus. PDA closure is indicated in patients with symptoms and evidence of left heart enlargement, and in patients with elevated pulmonary pressures when reversal is possible. Transcatheter closure is the preferred technique in adults because it avoids sternotomy, reduces the length of hospital stay and is associated with fewer complications compared with surgery. First demonstrated in 1967, both the technique and the occluder devices used have since evolved. However, designing an ideal PDA occluder has been a challenge due to the variability in size, shape and orientation of PDAs. The present article describes a case involving a 35-year-old woman who presented to the Center for Advanced Heart Failure (Houston, USA) with congestive heart failure due to a large PDA, which was successfully occluded using an Amplatzer (St Jude Medical, USA) muscular ventricular septal defect closure device. The wider waist and dual-retention discs of these ventricular septal defect closure devices may be important factors to consider in the future development of devices for the occlusion of large PDAs. PMID:24294051

Comparison of V-Loc™ 180 wound closure device and Quill™ PDO knotless tissue-closure device for intradermal closure in a porcine in vivo model: evaluation of biomechanical wound strength.

PubMed

Gingras, Kristen; Zaruby, Jeffrey; Maul, Don

2012-05-01

The objective of this study was to compare the biomechanical strength of two barbed suture devices: V-Loc™ 180 Wound Closure Device and Quill™ PDO Knotless Tissue-Closure Device following primary cosmetic skin closures in a porcine dermal model. This prospective randomized, controlled in vivo trial compared size 3/0 V-Loc™ 180 device to size 2/0 Quill™ PDO device. Both products were tested for dermal closure in adult porcine models and evaluated at five timepoints. At postoperative days 0, 3, 7, 14, and 28 sutured tissue regions were excised post mortem and tested for intradermal wound holding strength. Wounds closed with V-Loc™ 180 device were stronger than Quill™ PDO device at days 0, 3, 7, and 14 with these differences being significant (p < 0.05) at days 3 and 7. At day 3, the average maximum load of V-Loc™ 180 was 13.53 kgf and Quill™ PDO was 10.38 kgf (p = 0.002). At day 7, the average maximum load of V-Loc™ 180 was 10.4 kgf and Quill™ PDO was 7.56 kgf (p = 0.001). Throughout the duration of the study, there was no suture extrusion or tissue distortion and all wounds healed with no major complications. In this study, V-Loc™ 180 device was significantly stronger than Quill™ PDO device during the critical phases of wound healing in skin. Copyright © 2012 Wiley Periodicals, Inc.

Patent ductus arteriosus closure using an Amplatzer(™) ventricular septal defect closure device.

PubMed

Fernando, Rajeev; Koranne, Ketan; Loyalka, Pranav; Kar, Biswajit; Gregoric, Igor

2013-01-01

The ductus arteriosus originates from the persistence of the distal portion of the left sixth aortic arch. It connects the descending aorta (immediately distal to the left subclavian artery) to the roof of the main pulmonary artery, near the origin of the left pulmonary artery. Persistence of the duct beyond 48 h after birth is abnormal and results in patent ductus arteriosus (PDA). PDA is rare in adults because it is usually discovered and treated in childhood. Mechanical closure remains the definitive therapy because the patency of ductus arteriosus may lead to multiple complications, depending on the size and flow through the ductus. PDA closure is indicated in patients with symptoms and evidence of left heart enlargement, and in patients with elevated pulmonary pressures when reversal is possible. Transcatheter closure is the preferred technique in adults because it avoids sternotomy, reduces the length of hospital stay and is associated with fewer complications compared with surgery. First demonstrated in 1967, both the technique and the occluder devices used have since evolved. However, designing an ideal PDA occluder has been a challenge due to the variability in size, shape and orientation of PDAs. The present article describes a case involving a 35-year-old woman who presented to the Center for Advanced Heart Failure (Houston, USA) with congestive heart failure due to a large PDA, which was successfully occluded using an Amplatzer (St Jude Medical, USA) muscular ventricular septal defect closure device. The wider waist and dual-retention discs of these ventricular septal defect closure devices may be important factors to consider in the future development of devices for the occlusion of large PDAs.

Source replenishment device for vacuum deposition

DOEpatents

Hill, Ronald A.

1988-01-01

A material source replenishment device for use with a vacuum deposition apparatus. The source replenishment device comprises an intermittent motion producing gear arrangement disposed within the vacuum deposition chamber. An elongated rod having one end operably connected to the gearing arrangement is provided with a multiarmed head at the opposite end disposed adjacent the heating element of the vacuum deposition apparatus. An inverted U-shaped source material element is releasably attached to the outer end of each arm member whereby said multiarmed head is moved to locate a first of said material elements above said heating element, whereupon said multiarmed head is lowered to engage said material element with the heating element and further lowered to release said material element on the heating element. After vaporization of said material element, second and subsequent material elements may be provided to the heating element without the need for opening the vacuum deposition apparatus to the atmosphere.

Source replenishment device for vacuum deposition

DOEpatents

Hill, R.A.

1986-05-15

A material source replenishment device for use with a vacuum deposition apparatus is described. The source replenishment device comprises an intermittent motion producing gear arrangement disposed within the vacuum deposition chamber. An elongated rod having one end operably connected to the gearing arrangement is provided with a multiarmed head at the opposite end disposed adjacent the heating element of the vacuum deposition apparatus. An inverted U-shaped source material element is releasably attached to the outer end of each arm member whereby said multiarmed head is moved to locate a first of said material elements above said heating element, whereupon said multiarmed head is lowered to engage said material element with the heating element and further lowered to release said material element on the heating element. After vaporization of said material element, second and subsequent material elements may be provided to the heating element without the need for opening the vacuum deposition apparatus to the atmosphere.

Comparison of cost-effectiveness and postoperative outcome of device closure and open surgery closure techniques for treatment of patent ductus arteriosus.

PubMed

Ahmadi, Alireza; Sabri, Mohammadreza; Bigdelian, Hamid; Dehghan, Bahar; Gharipour, Mojgan

2014-01-01

Various devices have been recently employed for percutaneous closure of the patent ductus arteriosus (PDA). Although the high effectiveness of device closure techniques has been clearly determined, a few studies have focused on the cost-effectiveness and also postoperative complications of these procedures in comparison with open surgery. The present study aimed to evaluate the clinical outcome and cost-effectiveness of PDA occlusion by Amplatzer and coil device in comparisong with open surgery. In this cross-sectional study, a randomized sample of 201 patients aged 1 month to 16 years (105 patients with device closure and 96 patients with surgical closure) was selected. The ratio of total pulmonary blood flow to total systemic blood flow, the Qp/Qs ratio, was measured using a pulmonary artery catheter. The cost analysis included direct medical care costs associated with device implantation and open surgery, as well as professional fees. All costs were calculated in Iranian Rials and then converted to US dollars. There was no statistical difference in mean Qp/Qs ratio before the procedure between the device closure group and the open surgery group (2.1 ± 0.7 versus 1.7 ± 0.6, P = 0.090). The mean measured costs were overall higher in the device closure group than in open closure group (948.87 ± 548.76 US$ versus 743.70 ± 696.91 US$, P < 0.001). This difference remained significant after adjustment for age and gender (Standardized Beta = 0.160, P = 0.031). PDA closure with the Amplatzer ductal occluder (1053.05 ± 525.73 US$) or with Nit-Occlud coils (PFM) (912.73 ± 565.94 US$, P < 0.001) was more expensive than that via open surgery. However, the Cook detachable spring coils device closure (605.65 ± 194.62 US$, P = 0.650) had a non-significant cost difference with open surgery. No event was observed in the device closure group regarding in-hospital mortality or morbidity; however, in another group, 2 in-hospital deaths occurred, two patients experienced

Vacuum-assisted drainage in cardiopulmonary bypass: advantages and disadvantages

PubMed Central

de Carvalho Filho, Élio Barreto; Marson, Fernando Augusto de Lima; da Costa, Loredana Nilkenes Gomes; Antunes, Nilson

2014-01-01

Systematic review of vacuum assisted drainage in cardiopulmonary bypass, demonstrating its advantages and disadvantages, by case reports and evidence about its effects on microcirculation. We conducted a systematic search on the period 1997-2012, in the databases PubMed, Medline, Lilacs and SciELO. Of the 70 selected articles, 26 were included in the review. Although the vacuum assisted drainage has significant potential for complications and requires appropriate technology and professionalism, prevailed in literature reviewed the concept that vacuum assisted drainage contributed in reducing the rate of transfusions, hemodilutions, better operative field, no significant increase in hemolysis, reduced complications surgical, use of lower prime and of smaller diameter cannulas. PMID:25140478

Vacuum-assisted drainage in cardiopulmonary bypass: advantages and disadvantages.

PubMed

Carvalho Filho, Elio Barreto de; Marson, Fernando Augusto de Lima; Costa, Loredana Nilkenes Gomes da; Antunes, Nilson

2014-01-01

Systematic review of vacuum assisted drainage in cardiopulmonary bypass, demonstrating its advantages and disadvantages, by case reports and evidence about its effects on microcirculation. We conducted a systematic search on the period 1997-2012, in the databases PubMed, Medline, Lilacs and SciELO. Of the 70 selected articles, 26 were included in the review. Although the vacuum assisted drainage has significant potential for complications and requires appropriate technology and professionalism, prevailed in literature reviewed the concept that vacuum assisted drainage contributed in reducing the rate of transfusions, hemodilutions, better operative field, no significant increase in hemolysis, reduced complications surgical, use of lower prime and of smaller diameter cannulas.

Patent foramen ovale closure using a bioabsorbable closure device: safety and efficacy at 6-month follow-up.

PubMed

Van den Branden, Ben J; Post, Martijn C; Plokker, Herbert W; ten Berg, Jurriën M; Suttorp, Maarten J

2010-09-01

The aim of this study was to assess the mid-term safety and efficacy of percutaneous patent foramen ovale (PFO) closure using a bioabsorbable device (BioSTAR, NMT Medical, Boston, Massachusetts). Closure of PFO in patients with cryptogenic stroke has proven to be safe and effective using different types of permanent devices. All consecutive patients who underwent percutaneous PFO closure with the bioabsorbable closure device between November 2007 and January 2009 were included. Residual shunt was assessed using contrast transthoracic echocardiography. Sixty-two patients (55% women, mean age 47.7 ± 11.8 years) underwent PFO closure. The in-hospital complications were a surgical device retrieval in 2 patients (3.2%), device reposition in 1 (1.6%), and a minimal groin hematoma in 6 patients (9.7%). The short-term complications at 1-month follow-up (n = 60) were a transient ischemic attack in the presence of a residual shunt in 1 patient and new supraventricular tachycardia in 7 patients (11.3%). At 6-month follow-up (n = 60), 1 patient without residual shunt developed a transient ischemic attack and 1 developed atrial fibrillation. A mild or moderate residual shunt was noted in 51.7%, 33.9%, and 23.7% after 1-day, 1-month, and 6-month follow-up, respectively. A large shunt was present in 8.3%, 3.4%, and 0% after 1-day, 1-month, and 6-month follow-up. Closure of PFO using the bioabsorbable device is associated with a low complication rate and a low recurrence rate of embolic events. However, a relatively high percentage of mild or moderate residual shunting is still present at 6-month follow-up. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Early decision-analytic modeling - a case study on vascular closure devices.

PubMed

Brandes, Alina; Sinner, Moritz F; Kääb, Stefan; Rogowski, Wolf H

2015-10-27

As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account not only medical need and potential clinical effectiveness, but also cost-effectiveness. Already early in the innovation process economic evaluations can support decisions on development in specific indications or patient groups by anticipating future reimbursement and implementation decisions. One potential concept for early assessment is value-based pricing. The objective is to assess the feasibility of value-based pricing and product design for a hypothetical vascular closure device in the pre-clinical stage which aims at decreasing bleeding events. A deterministic decision-analytic model was developed to estimate the cost-effectiveness of established vascular closure devices from the perspective of the Statutory Health Insurance system. To identify early benchmarks for pricing and product design, three strategies of determining the product's value are explored: 1) savings from complications avoided by the new device; 2) valuation of the avoided complications based on an assumed willingness-to-pay-threshold (the efficiency frontier approach); 3) value associated with modifying the care pathways within which the device would be applied. Use of established vascular closure devices is dominated by manual compression. The hypothetical vascular closure device reduces overall complication rates at higher costs than manual compression. Maximum cost savings of only about €4 per catheterization could be realized by applying the hypothetical device. Extrapolation of an efficiency frontier is only possible for one subgroup where vascular closure devices are not a dominated strategy. Modifying care in terms of same-day discharge of patients treated with vascular closure devices could result in cost savings of €400-600 per catheterization. It was partially feasible to calculate value-based prices for the

SLAC All Access: Vacuum Microwave Device Department

ScienceCinema

Haase, Andy

2018-05-11

The Vacuum Microwave Device Department (VMDD) builds the devices that make SLAC's particle accelerators go. These devices, called klystrons, generate intense waves of microwave energy that rocket subatomic particles up to nearly the speed of light.

SLAC All Access: Vacuum Microwave Device Department

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haase, Andy

2012-10-09

The Vacuum Microwave Device Department (VMDD) builds the devices that make SLAC's particle accelerators go. These devices, called klystrons, generate intense waves of microwave energy that rocket subatomic particles up to nearly the speed of light.

Closure device for lead-acid batteries

DOEpatents

Ledjeff, Konstantin

1983-01-01

A closure device for lead-acid batteries includes a filter of granulated activated carbon treated to be hydrophobic combined with means for preventing explosion of emitted hydrogen and oxygen gas. The explosion prevention means includes a vertical open-end tube within the closure housing for maintaining a liquid level above side wall openings in an adjacent closed end tube. Gases vent from the battery through a nozzle directed inside the closed end tube against an impingement surface to remove acid droplets. The gases then flow through the side wall openings and the liquid level to quench any possible ignition prior to entering the activated carbon filter. A wick in the activated carbon filter conducts condensed liquid back to the closure housing to replenish the liquid level limited by the open-end tube.

Ultrasound-Guided Core-Needle Versus Vacuum-Assisted Breast Biopsy: A Cost Analysis Based on the American Society of Breast Surgeons' Mastery of Breast Surgery Registry.

PubMed

Grady, Ian; Vasquez, Tony; Tawfik, Sara; Grady, Sean

2017-03-01

To evaluate the cost-efficacy of vacuum-assisted ultrasound-guided breast biopsy instruments compared to ultrasound-guided 14-gauge spring-loaded core-needle biopsy. The American Society of Breast Surgeons' Mastery of Breast Surgery Registry was reviewed. Biopsy findings, any rebiopsy, and the instrument used were abstracted for 31,451 ultrasound-guided biopsy procedures performed between 2001 and July 2014. Rates of cancer diagnosis and rebiopsy were calculated for each instrument. A linear mathematical model was developed to calculate total cost per cancer diagnosis, including procedural costs and the costs of any additional surgical rebiopsy procedures. Mean cost per cancer diagnosis with confidence limits was then determined for 14-gauge spring-loaded core-needle biopsy and 14 different vacuum-assisted instruments. For 14-gauge spring-loaded core-needle biopsy, mean cost per cancer diagnosis was $4346 (4327-$4366). For the vacuum-assisted instruments, mean cost per cancer diagnosis ranged from a low of $3742 ($3732-$3752) to a high of $4779 ($4750-$4809). Vacuum-assisted instruments overall were more cost-effective than core with a mean cost per cancer diagnosis of $4052 ($4038-$4067) (p < 0.05). Tethered vacuum-assisted instruments performed best with a mean cost per cancer diagnosis of $3978 ($3964-$3991) (p < 0.05). Nontethered devices had a mean cost per cancer diagnosis of $4369 ($4350-$4388), a result no better than core (p < 0.05). Ultrasound-guided vacuum-assisted breast biopsy had a lower mean cost per cancer diagnosis than 14-gauge spring-loaded core-needle biopsy. This advantage was only seen in tethered vacuum-assisted instruments. Within device families, larger instruments tended to outperform smaller instruments.

Simple Skin-Stretching Device in Assisted Tension-Free Wound Closure.

PubMed

Cheng, Li-Fu; Lee, Jiunn-Tat; Hsu, Honda; Wu, Meng-Si

2017-03-01

Numerous conventional wound reconstruction methods, such as wound undermining with direct suture, skin graft, and flap surgery, can be used to treat large wounds. The adequate undermining of the skin flaps of a wound is a commonly used technique for achieving the closure of large tension wounds; however, the use of tension to approximate and suture the skin flaps can cause ischemic marginal necrosis. The purpose of this study is to use elastic rubber bands to relieve the tension of direct wound closure for simultaneously minimizing the risks of wound dehiscence and wound edge ischemia that lead to necrosis. This retrospective study was conducted to evaluate our clinical experiences with 22 large wounds, which involved performing primary closures under a considerable amount of tension by using elastic rubber bands in a skin-stretching technique after a wide undermining procedure. Assessment of the results entailed complete wound healing and related complications. All 22 wounds in our study showed fair to good results except for one. The mean success rate was approximately 95.45%. The simple skin-stretching design enabled tension-free skin closure, which pulled the bilateral undermining skin flaps as bilateral fasciocutaneous advancement flaps. The skin-stretching technique was generally successful.

Simple skin-stretching device in assisted tension-free wound closure

PubMed Central

Cheng, Li-Fu; Lee, Jiunn-Tat; Hsu, Honda; Wu, Meng-Si

2017-01-01

Background Numerous conventional wound reconstruction methods such as wound undermining with direct suture, skin graft, and flap surgery can be used to treat large wounds. The adequate undermining of the skin flaps of a wound is a commonly used technique for achieving the closure of large tension wounds; however, the use of tension to approximate and suture the skin flaps can cause ischemic marginal necrosis. The purpose of this study is to use elastic rubber bands to relieve the tension of direct wound closure for simultaneously minimizing the risks of wound dehiscence and wound edge ischemia that lead to necrosis. Materials and Methods This retrospective study was conducted to evaluate our clinical experiences with 22 large wounds, which involved performing primary closures under a considerable amount of tension by using elastic rubber bands in a skin-stretching technique following a wide undermining procedure. Assessment of the results entailed complete wound healing and related complications. Results All 22 wounds in our study showed fair to good results except for one. The mean success rate was approximately 95.45%. Conclusion The simple skin-stretching design enabled tension-free skin closure, which pulled the bilateral undermining skin flaps as bilateral fasciocutaneous advancement flaps. The skin-stretching technique was generally successful. PMID:28195891

Initial Experience with a Wireless Ultrasound-Guided Vacuum-Assisted Breast Biopsy Device

PubMed Central

Choi, E-Ryung; Han, Boo-Kyung; Ko, Eun Sook; Ko, Eun Young; Choi, Ji Soo; Cho, Eun Yoon; Nam, Seok Jin

2015-01-01

Objective To determine the imaging characteristic of frequent target lesions of wireless ultrasound (US)-guided, vacuum-assisted breast biopsy (Wi-UVAB) and to evaluate diagnostic yield, accuracy and complication of the device in indeterminate breast lesions. Materials and Methods From March 2013 to October 2014, 114 women (age range, 29–76 years; mean age, 50.0 years) underwent Wi-UVAB using a 13-gauge needle (Mammotome Elite®; Devicor Medical Products, Cincinnati, OH, USA). In 103 lesions of 96 women with surgical (n = 81) or follow-up (n = 22) data, complications, biopsy procedure, imaging findings of biopsy targets and histologic results were reviewed. Results Mean number of biopsy cores was 10 (range 4–25). Nine patients developed moderate bleeding. All lesions were suspicious on US, and included non-mass lesions (67.0%) and mass lesions (33.0%). Visible calcifications on US were evident in 57.3% of the target lesions. Most of the lesions (93.2%) were nonpalpable. Sixty-six (64.1%) were malignant [ductal carcinoma in situ (DCIS) rate, 61%] and 12 were high-risk lesions (11.7%). Histologic underestimation was identified in 11 of 40 (27.5%). DCIS cases and in 3 of 9 (33.3%) high-risk lesions necessitating surgery. There was no false-negative case. Conclusion Wi-UVAB is very handy and advantageous for US-unapparent non-mass lesions to diagnose DCIS, especially for calcification cases. Histologic underestimation is unavoidable; still, Wi-UVAB is safe and accurate to diagnose a malignancy. PMID:26630136

The effect of vacuum devices on penile hemodynamics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Katz, P.G.; Haden, H.T.; Mulligan, T.

1990-01-01

External vacuum devices are being used increasingly for the management of erectile dysfunction. There is limited information regarding the effect of vacuum devices on penile blood flow and potential for ischemic penile injury. The penile xenon washout rate was measured before and after application of 2 vacuum systems in 15 subjects. Compared to flaccid state measurements the xenon washout rate did not change significantly with the Synergist Erection System but it was significantly reduced with the Osbon ErecAid System. However, the degree and duration of decrease in penile blood flow that may result in ischemic changes are unknown.

Predicting Peri-Device Leakage of Left Atrial Appendage Device Closure Using Novel Three-Dimensional Geometric CT Analysis.

PubMed

Chung, Hyemoon; Jeon, Byunghwan; Chang, Hyuk-Jae; Han, Dongjin; Shim, Hackjoon; Cho, In Jeong; Shim, Chi Young; Hong, Geu-Ru; Kim, Jung-Sun; Jang, Yangsoo; Chung, Namsik

2015-12-01

After left atrial appendage (LAA) device closure, peri-device leakage into the LAA persists due to incomplete occlusion. We hypothesized that pre-procedural three-dimensional (3D) geometric analysis of the interatrial septum (IAS) and LAA orifice can predict this leakage. We investigated the predictive parameters of LAA device closure obtained from baseline cardiac computerized tomography (CT) using a novel 3D analysis system. We conducted a retrospective study of 22 patients who underwent LAA device closure. We defined peri-device leakage as the presence of a Doppler signal inside the LAA after device deployment (group 2, n = 5) compared with patients without peri-device leakage (group 1, n = 17). Conventional parameters were measured by cardiac CT. Angles θ and φ were defined between the IAS plane and the line, linking the LAA orifice center and foramen ovale. Group 2 exhibited significantly better left atrial (LA) function than group 1 (p = 0.031). Pre-procedural θ was also larger in this group (41.9° vs. 52.3°, p = 0.019). The LAA cauliflower-type morphology was more common in group 2. Overall, the patients' LA reserve significantly decreased after the procedure (21.7 mm(3) vs. 17.8 mm(3), p = 0.035). However, we observed no significant interval changes in pre- and post-procedural values of θ and φ in either group (all p > 0.05). Angles between the IAS and LAA orifice might be a novel anatomical parameter for predicting peri-device leakage after LAA device closure. In addition, 3D CT analysis of the LA and LAA orifice could be used to identify clinically favorable candidates for LAA device closure.

Transcatheter Closure of Patent Foramen Ovale: Devices and Technique.

PubMed

Price, Matthew J

2017-10-01

Transcatheter closure of a patent foramen ovale (PFO) reduces the risk of recurrent cryptogenic stroke compared with medical therapy. PFO closure is a prophylactic procedure, and will not provide the patient with symptomatic improvement, except in cases of hypoxemia due to right-to-left shunt or possibly migraine headaches. Therefore, appropriate patient selection is critical, and procedural safety is paramount. Herein, we review key characteristics of the devices currently available for transcatheter PFO closure within the United States, and highlight key technical aspects of the PFO closure procedure that will maximize procedural success. Copyright © 2017 Elsevier Inc. All rights reserved.

The open abdomen and temporary abdominal closure systems--historical evolution and systematic review.

PubMed

Quyn, A J; Johnston, C; Hall, D; Chambers, A; Arapova, N; Ogston, S; Amin, A I

2012-08-01

Several techniques for temporary abdominal closure have been developed. We systematically review the literature on temporary abdominal closure to ascertain whether the method can be tailored to the indication. Medline, Embase, the Cochrane Central Register of Controlled Trials and relevant meeting abstracts until December 2009 were searched using the following headings: open abdomen, laparostomy, VAC (vacuum assisted closure), TNP (topical negative pressure), fascial closure, temporary abdominal closure, fascial dehiscence and deep wound dehiscence. The data were analysed by closure technique and aetiology. The primary end-points included delayed fascial closure and in-hospital mortality. The secondary end-points were intra-abdominal complications. The search identified 106 papers for inclusion. The techniques described were VAC (38 series), mesh/sheet (30 series), packing (15 series), Wittmann patch (eight series), Bogotá bag (six series), dynamic retention sutures (three series), zipper (15 series), skin only and locking device (one series each). The highest facial closure rates were seen with the Wittmann patch (78%), dynamic retention sutures (71%) and VAC (61%). Temporary abdominal closure has evolved from simple packing to VAC based systems. In the absence of sepsis Wittmann patch and VAC offered the best outcome. In its presence VAC had the highest delayed primary closure and the lowest mortality rates. However, due to data heterogeneity only limited conclusions can be drawn from this analysis. © 2012 The Authors. Colorectal Disease © 2012 The Association of Coloproctology of Great Britain and Ireland.

Right Ventricle before and after Atrial Septal Defect Device Closure.

PubMed

Akula, Vidya Sagar; Durgaprasad, Rajasekhar; Velam, Vanajakshamma; Kasala, Latheef; Rodda, Madhavi; Erathi, Harsha Vardhan

2016-09-01

Percutaneous atrial septal defect (ASD) device closure is a safe and effective means of reducing or eliminating interatrial shunting. The response of the right heart to device closure is incompletely understood. To evaluate the effects of transcatheter closure of secundum ASD on right ventricle size and function, that is, both systolic and diastolic by transthoracic echocardiography (TTE) over a 6-month period. Seventy-three patients had 73 device implantations. The patients were assessed with echocardiography before and at 1 and 6 months after procedure. Mean age was 26 ± 17 years. Mean ASD size indexed to body surface area (BSA) was 19.1 ± 8.6 mm/m(2) . The device size ranged from 12 to 42 mm. One month after closure, there were statistically significant decreases in right ventricular (RV) basal diameter (3.5 ± 0.7 cm vs. 4.2 ± 0.8 cm), RV/LV end-diastolic diameter ratio (0.9 ± 0.1 vs. 1.2 ± 0.2), left ventricular eccentricity index (LVEI) (1.0 ± 0.1 vs. 1.2 ± 0.2), right atrial (RA) major dimension (4.4 ± 0.8 cm vs. 4.8 ± 1.0 cm), RA end-systolic area (13.2 ± 4.6 cm(2) vs. 18.5 ± 6.7 cm(2) ), tricuspid annular plane systolic excursion (TAPSE) (2.2 ± 1.8 cm vs. 2.8 ± 0.5 cm), tricuspid annular systolic velocity (TASV or S') (13.1 ± 3.0 cm/sec vs. 16.0 ± 2.8 cm/sec), E/A (1.4 ± 0.3 vs. 1.7 ± 0.5), and E/e' (5.9 ± 5.0 vs. 7.2 ± 2.0) in comparison with baseline. Six months after closure, there were statistically significant decreases in RV major dimension (5.9 ± 1.1 cm vs. 6.3 ± 1.0 cm), RV/LV end-diastolic diameter ratio (0.8 ± 0.1 vs. 0.9 ± 0.1), RA major dimension (4.1 ± 0.8 cm vs. 4.4 ± 0.8 cm), and RA end-systolic area (11.4 ± 3.8 cm(2) vs. 13.2 ± 4.6 cm(2) ) in comparison with 1 month post-device closure. After 6 months, there was a statistically insignificant increase in both TASV (13.7 ± 2.8 cm/sec vs. 13.1 ± 3.0 cm/sec) and TAPSE (2.5 ± 1.6 cm/sec vs. 2.2 ± 1.8 cm/sec). There was no significant change in tissue Doppler MPI at

Transcutaneous closure of chronic broncho-pleuro-cutaneous fistula by duct occluder device

PubMed Central

Marwah, Vikas; Ravikumar, R; Rajput, Ashok Kumar; Singh, Amandeep

2016-01-01

Bronchopleural fistula (BPF) is a well known complication of several pulmonary conditions posing challenging management problem and is often associated with high morbidity and mortality. Though no consensus exists on a definite closure management algorithm, strategies for closure widely include various methods like tube thoracostomy with suction, open surgical closure, bronchoscopy directed glue, coiling and sealants which now also includes use of occlusion devices. We report a case in which a novel method of delivery and closure of recurrent post-operative broncho-pleuro-cutaneous fistula by a duct occluder device was done transcutaneously which has not been previously described in literature. PMID:27051115

Nickel elution properties of contemporary interatrial shunt closure devices.

PubMed

Verma, Divya Ratan; Khan, Muhammad F; Tandar, Anwar; Rajasekaran, Namakkal S; Neuharth, Renée; Patel, Amit N; Muhlestein, Joseph B; Badger, Rodney S

2015-02-01

We sought to compare nickel elution properties of contemporary interatrial shunt closure devices in vitro. There are two United States Food and Drug Administration (FDA)-approved devices for percutaneous closure of secundum atrial septal defect: the Amplatzer septal occluder (ASO; St Jude Medical Corporation) and Gore Helex septal occluder (HSO; W.L. Gore & Associates). The new Gore septal occluder (GSO) device is in clinical trials. These are also used off-label for patent foramen ovale closure in highly selected patients. These devices have high nickel content. Nickel allergy is the most common reason for surgical device explantation. Nickel elution properties of contemporary devices remain unknown. We compared nickel elution properties of 4 devices - ASO, GSO, HSO, and sternal wire (SW) - while Dulbecco's phosphate-buffered saline (DPBS) served as control. Three samples of each device were submerged in DPBS. Nickel content was measured at 14 intervals over 90 days. Nickel elution at 24 hours, compared to control (0.005 ± 0.0 mg/L), was significantly higher for ASO (2.98 ± 1.65 mg/L; P=.04) and SW (0.03 ± 0.014 mg/L; P=.03). Nickel levels at 90 days, compared to control (0.005 ± 0.0 mg/L) and adjusting for multiple comparisons, were significantly higher for ASO (19.80 ± 2.30 mg/L; P=.01) and similar for HSO (P=.34), GSO (P=.34), and SW (P=.34). ASO had significantly higher nickel elution compared to HSO, GSO, and SW (P=.01). There is substantial variability in nickel elution; devices with less exposed nickel (HSO and GSO) have minimal elution. The safety of low nickel elution devices in patients with nickel allergy needs to be evaluated in prospective trials.

CLOSURE DEVICE

DOEpatents

Linzell, S.M.; Dorcy, D.J.

1958-08-26

A quick opening type of stuffing box employing two banks of rotatable shoes, each of which has a caraming action that forces a neoprene sealing surface against a pipe or rod where it passes through a wall is presented. A ring having a handle or wrench attached is placed eccentric to and between the two banks of shoes. Head bolts from the shoes fit into slots in this ring, which are so arranged that when the ring is rotated a quarter turn in one direction the shoes are thrust inwardly to cramp the neopnrene about the pipe, malting a tight seal. Moving the ring in the reverse direction moves the shoes outwardly and frees the pipe which then may be readily removed from the stuffing box. This device has particular application as a closure for the end of a coolant tube of a neutronic reactor.

Early intervention of negative pressure wound therapy using Vacuum-Assisted Closure in trauma patients: impact on hospital length of stay and cost.

PubMed

Kaplan, Mark; Daly, Darron; Stemkowski, Stephen

2009-03-01

The cost of treating complex traumatic wounds is substantial because of trauma severity, potential for infection, and delayed closure. Negative pressure wound therapy using reticulated open cell foam (NPWT/ROCF) as delivered by Vacuum-Assisted Closure* (KCI Licensing, Inc, San Antonio, Texas) is an established, viable option for treating traumatic wounds. The authors used retrospective data to study the clinical and cost-effective benefits of using NPWT/ROCF early on day 1 or day 2 of treatment for traumatic wounds as compared with using it late (on day 3 or later). Hospital data records from trauma wound patients treated with NPWT/ROCF were retrospectively analyzed. Data were subdivided into 2 groups based on start of treatment. The group of patients treated on day 1 or 2 of their hospital stay was referred to as the early group, and that composed of patients treated on day 3 or later as the late group. Clinical and cost-effective metrics were compared between the 2 groups. For the early group, 518 patient records were included; 1000 records were reviewed for the late group. Early-group patients had fewer hospital inpatient days (10.6 vs 20.6 days; P < .0001), fewer treatment days (5.1 vs 6.0 days; P = .0498), shorter intensive care unit (ICU) stays (5.3 vs 12.4 days; P < .0001), and higher ICU admission rates (51.5 vs 44.5%; P = .0091) than the late group. Compared with late-group patients, early-group patients had lower total and variable costs per patient discharge ($43,956 vs $32,175; P < .0001 and $22,891 vs $15,805; P < .0001, respectively). Acute-care trauma wound patients receiving early NPWT/ROCF demonstrated significant reductions in length of stay, treatment days, and ICU stay, which resulted in significant reduced patient treatment costs. These results indicate that early intervention with NPWT/ROCF has potential clinical and cost-effective benefits for the treatment of traumatic wounds.

Percutaneous device closure of patent ductus arteriosus with pulmonary artery hypertension: long-term results.

PubMed

Vijayalakshmi, Ishwarappa Balekundri; Setty, Natraj; Narasimhan, Chitra; Singla, Vivek; Manjunath, Cholenahalli Nanjappa

2014-12-01

Device closure of patent ductus arteriosus (PDA) is treatment of choice. But device closure in presence of pulmonary artery hypertension (PAH) remains a challenge. Data on patient selection, technical considerations, and complications are limited. To know the challenges and efficacy of device closure of PDA with PAH. Out of 1,325 cases of device closure of PDA, 246 (18.6%) with PAH formed the study material. To test the feasibility, chosen device is used to occlude PDA for ten minutes without oxygen inhalation. The device is released only if PAH reduced. PAH decreased in all except in 1 patient after closure with muscular ventricular septal occluder (MVSDO), pulmonary artery pressure (PAP) transiently increased (became supra-systemic), without significant reduction in aortic pressure. Device embolized in 8 patients (3.3%). Percutaneous retrieval was done in 4 (by snare in 2 and by fixing the cable to device in 2) and replaced with bigger devices. The surgical removal of the embolized MVSDO and ligation was done in 4 cases. All patients were on oral sildenafil and bosentan until PAP regressed to normal. Follow up was from 6 months to 9 years. No residual shunt in any patient on follow-up. The PAP regressed to normal in all except 5 cases (2.03%) of Down's syndrome with systemic PAP. Device closure of PDA with PAH is feasible, safe in all age groups. Temporary PDA occlusion with device is effective and time saving for evaluating pulmonary vascular reactivity. Device embolization in aorta is higher with severe PAH. Novel method of retrieval is effective. © 2014, Wiley Periodicals, Inc.

Comparison of two spectral domain optical coherence tomography devices for angle-closure assessment.

PubMed

Quek, Desmond T; Narayanaswamy, Arun K; Tun, Tin A; Htoon, Hla M; Baskaran, Mani; Perera, Shamira A; Aung, Tin

2012-08-03

To compare two spectral domain optical coherence tomography (SD-OCT) devices for the identification of angle structures and the presence of angle closure. This was a prospective comparative study. Consecutive patients underwent gonioscopy and anterior segment imaging using two SD-OCT devices (iVue and Cirrus). Images were evaluated for the ability to detect angle structures such as Schwalbe's line (SL), trabecular meshwork (TM), Schlemm's canal (SC), and scleral spur (SS), and the presence of angle closure. Angle closure was defined as iris contact with the angle wall anterior to the SS on SD-OCT, and nonvisibility of the posterior TM on gonioscopy. Angle closure in an eye was defined as ≥two quadrants of closed angles. AC1 statistic was used to assess the agreement between devices. Of the 69 subjects studied (46.4% male, 84.1% Chinese, mean age 64.0 ± 10.5 years), 40 subjects (40 eyes, 58.0%) had angle closure on gonioscopy. The most identifiable structure on Cirrus SD-OCT was the SS (82.2%) and SL on iVue SD-OCT (74.5%). Angle closure was indeterminable in 14.5% and 50.7% of Cirrus and iVue scans (P < 0.001), respectively. Interdevice agreement for angle closure was moderately strong (AC1 = 0.67), but agreement with gonioscopy was only fair (AC1 = 0.35 and 0.50 for Cirrus and iVue, respectively). It was more difficult to determine angle closure status with iVue compared with Cirrus SD-OCT. There was fair agreement between both devices with gonioscopy for identifying angle closure.

Phacoemulsification tip vacuum pressure: Comparison of 4 devices.

PubMed

Payne, Marielle; Georgescu, Dan; Waite, Aaron N; Olson, Randall J

2006-08-01

To determine the vacuum pressure generated by 4 phacoemulsification devices measured at the phacoemulsification tip. University ophthalmology department. The effective vacuum pressures generated by the Sovereign (AMO), Millennium (Bausch & Lomb), Legacy AdvanTec (Alcon Laboratories), and Infiniti (Alcon Laboratories) phacoemulsification machines were measured with a device that isolated the phacoemulsification tip in a chamber connected to a pressure gauge. The 4 machines were tested at multiple vacuum limit settings, and the values were recorded after the foot pedal was fully depressed and the pressure had stabilized. The AdvanTec and Infiniti machines were tested with and without occlusion of the Aspiration Bypass System (ABS) side port (Alcon Laboratories). The Millennium machine was tested using venturi and peristaltic pumps. The machines generated pressures close to the expected at maximum vacuum settings between 100 mm Hg and 500 mm Hg with few intermachine variations. There was no significant difference between pressures generated using 19- or 20-gauge tips (Millennium and Sovereign). The addition of an ABS side port decreased vacuum by a mean of 12.1% (P < .0001). Although there were some variations in vacuum pressures among phacoemulsification machines, particularly when an aspiration bypass tip was used, these discrepancies are probably not clinically significant.

Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.

PubMed

Doyle, Brendan J; Godfrey, Michael J; Lennon, Ryan J; Ryan, James L; Bresnahan, John F; Rihal, Charanjit S; Ting, Henry H

2007-02-01

The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization. Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved. The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery. The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications. (c) 2006 Wiley-Liss, Inc.

A Practical Scoring System to Select Optimally Sized Devices for Percutaneous Patent Foramen Ovale Closure.

PubMed

Venturini, Joseph M; Retzer, Elizabeth M; Estrada, J Raider; Mediratta, Anuj; Friant, Janet; Nathan, Sandeep; Paul, Jonathan D; Blair, John; Lang, Roberto M; Shah, Atman P

2016-10-01

Patent foramen ovale (PFO) has been linked to cryptogenic stroke, and closure has been reported to improve clinical outcomes. However, there are no clear guidelines to direct device sizing. This study sought to use patient characteristics and echocardiographic findings to create a prediction score for device sizing. This was a retrospective review of patients undergoing percutaneous PFO closure at our institution between July 2010 and December 2014. Demographic and clinical characteristics were recorded, and all pre- and intraprocedural echocardiography results were evaluated. Thirty-six patients underwent percutaneous PFO closure during the study period. All procedures were performed using an Amplatzer Septal Occluder "Cribriform" (ASOC) device in one of three disc diameters: 25, 30, or 35 mm. Closure was indicated for cryptogenic stroke/transient ischemic attack in 75% of cases. Every case (100%) was successful with durable shunt correction at the 6-month follow-up without complications of erosion or device embolization. The presence of atrial septal aneurysm (ASA) ( p = 0.027) and PFO tunnel length >10 mm ( p = 0.038) were independently associated with increased device size. A scoring system of 1 point for male sex, 1 point for ASA, and 1 point for PFO tunnel >10 mm long was associated with the size of closure device implanted ( p = 0.006). A simple scoring system may be used to select an optimally sized device for percutaneous PFO closure using the ASOC device.

Method Of Making A Vacuum-Tight Continuous Cable Feedthrough Device

DOEpatents

Bazizi, Kamel Abdel; Haelen, Thomas Eugene; Lobkowicz, Frederick; Slattery, Paul Francis

2001-07-17

A vacuum-tight cable feedthrough device includes a metallic first flange that is penetrated by a slot. Passing through the slot is a flat stripline cable that includes a plurality of conductive signal channels encompassed by a dielectric material on whose upper and lower surfaces is disposed a conductive material includes a ground. The stripline cable is sealed within the slot to provide a substantially vacuum-tight seal between the cable and the first flange. In a preferred embodiment, the cable feedthrough device includes a plurality, at least 16, of stripline cables. In a further preferred embodiment, the device includes a second flange and a bellows sealably connecting the first and second flanges, thereby providing a substantially vacuum-tight, flexible housing for the plurality of cables.

Device-less patent foramen ovale closure by radiofrequency thermal energy.

PubMed

Walpoth, Nazan B; Habermacher, Kathrin; Moarof, Igal; Watson, Sandy; Wahl, Andreas; Windecker, Stephan; Schönenberger, Christa; Meier, Bernhard

2008-02-23

The goal of this study was to assess the feasibility, safety and success of a system which uses radiofrequency energy (RFE) rather than a device for percutaneous closure of patent foramen ovale (PFO). Sixteen patients (10 men, 6 women, mean age 50 years) were included in the study. All of them had a proven PFO with documented right-to-left shunt (RLS) after Valsalva manoeuvre (VM) during transoesophageal echocardiography (TEE). The patients had an average PFO diameter of 6 +/- 2 mm at TEE and an average of 23 +/- 4 microembolic signals (MES) in power M-mode transcranial Doppler sonography (pm-TCD), measured over the middle cerebral artery. An atrial septal aneurysm (ASA) was present in 7 patients (44%). Balloon measurement, performed in all patients, revealed a stretched PFO diameter of 8 +/- 3 mm. In 2 patients (stretched diameter 11 and 14 mm respectively, both with ASA >10 mm), radiofrequency was not applied (PFO too large) and the PFO was closed with an Amplatzer PFO occluder instead. A 6-month follow-up TEE was performed in all patients. There were no serious adverse events during the procedure or at follow-up (12 months average). TEE 6 months after the first RFE procedure showed complete closure of the PFO in 50% of the patients (7/14). Closure appeared to be influenced by PFO diameter, complete closure being achieved in 89% (7/8) with a balloon-stretched diameter < or =7 mm but in none of the patients >7 mm. Only one of the complete closure patients had an ASA. Of the remainder, 4 (29%) had an ASA. Although the PFO was not completely closed in this group, some reduction in the diameter of the PFO and in MES was documented by TEE and pm-TCD with VM. Five of the 7 residual shunt patients received an Amplatzer PFO occluder. Except for one patient with a minimal residual shunt, all showed complete closure of PFO at 6-month follow-up TEE and pm-TCD with VM. The other two refused a closure device. The results confirm that radiofrequency closure of the PFO is safe

Integrated cooling-vacuum-assisted 1540-nm erbium:glass laser is effective in treating mild-to-moderate acne vulgaris.

PubMed

Politi, Y; Levi, A; Enk, C D; Lapidoth, M

2015-12-01

Acne treatment by a mid-infrared laser may be unsatisfactory due to deeply situated acne-affected sebaceous glands which serve as its target. Skin manipulation by vacuum and contact cooling may improve laser-skin interaction, reduce pain sensation, and increase overall safety and efficacy. To evaluate the safety and efficacy of acne treatment using an integrated cooling-vacuum-assisted 1540-nm erbium:glass laser, a prospective interventional study was conducted. It included 12 patients (seven men and five women) suffering from mild-to-moderate acne vulgaris. The device utilizes a mid-infrared 1540-nm laser (Alma Lasers Ltd. Caesarea, Israel), which is integrated with combined cooling-vacuum-assisted technology. An acne lesion is initially manipulated upon contact by a vacuum-cooling-assisted tip, followed by three to four stacked laser pulses (500-600 mJ, 4 mm spot size, and frequency of 2 Hz). Patients underwent four to six treatment sessions with a 2-week interval and were followed-up 1 and 3 months after the last treatment. Clinical photographs were taken by high-resolution digital camera before and after treatment. Clinical evaluation was performed by two independent dermatologists, and results were graded on a scale of 0 (exacerbation) to 4 (76-100 % improvement). Patients' and physicians' satisfaction was also recorded. Pain perception and adverse effects were evaluated as well. All patients demonstrated a moderate to significant improvement (average score of 3.6 and 2.0 within 1 and 3 months, respectively, following last treatment session). No side effects, besides a transient erythema, were observed. Cooling-vacuum-assisted 1540-nm laser is safe and effective for the treatment of acne vulgaris.

Vacuum decay container/closure integrity testing technology. Part 2. Comparison to dye ingress tests.

PubMed

Wolf, Heinz; Stauffer, Tony; Chen, Shu-Chen Y; Lee, Yoojin; Forster, Ronald; Ludzinski, Miron; Kamat, Madhav; Mulhall, Brian; Guazzo, Dana Morton

2009-01-01

Part 1 of this series demonstrated that a container closure integrity test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method using a VeriPac 325/LV vacuum decay leak tester by Packaging Technologies & Inspection, LLC (PTI) is capable of detecting leaks > or = 5.0 microm (nominal diameter) in rigid, nonporous package systems, such as prefilled glass syringes. The current study compared USP, Ph.Eur. and ISO dye ingress integrity test methods to PTI's vacuum decay technology for the detection of these same 5-, 10-, and 15-microm laser-drilled hole defects in 1-mL glass prefilled syringes. The study was performed at three test sites using several inspectors and a variety of inspection conditions. No standard dye ingress method was found to reliably identify all holed syringes. Modifications to these standard dye tests' challenge conditions increased the potential for dye ingress, and adjustments to the visual inspection environment improved dye ingress detection. However, the risk of false positive test results with dye ingress tests remained. In contrast, the nondestructive vacuum decay leak test method reliably identified syringes with holes > or = 5.0 microm.

Cermet insert high voltage holdoff for ceramic/metal vacuum devices

DOEpatents

Ierna, William F.

1987-01-01

An improved metal-to-ceramic seal is provided wherein the ceramic body of the seal contains an integral region of cermet material in electrical contact with the metallic member, e.g., an electrode, of the seal. The seal is useful in high voltage vacuum devices, e.g., vacuum switches, and increases the high-voltage holdoff capabilities of such devices. A method of fabricating such seals is also provided.

Left Atrial Appendage Closure for Stroke Prevention: Devices, Techniques, and Efficacy.

PubMed

Iskandar, Sandia; Vacek, James; Lavu, Madhav; Lakkireddy, Dhanunjaya

2016-05-01

Left atrial appendage closure can be performed either surgically or percutaneously. Surgical approaches include direct suture, excision and suture, stapling, and clipping. Percutaneous approaches include endocardial, epicardial, and hybrid endocardial-epicardial techniques. Left atrial appendage anatomy is highly variable and complex; therefore, preprocedural imaging is crucial to determine device selection and sizing, which contribute to procedural success and reduction of complications. Currently, the WATCHMAN is the only device that is approved for left atrial appendage closure in the United States. Copyright © 2016 Elsevier Inc. All rights reserved.

New suturing technique for robotic-assisted vaginal cuff closure during single-site hysterectomy.

PubMed

Shin, So-Jin; Chung, Hyewon; Kwon, Sang-Hoon; Cha, Soon-Do; Cho, Chi-Heum

2017-06-01

To describe a simple and efficient technique for suturing the vaginal cuff in robotic-assisted single-site hysterectomy using barbed suture and a straight needle. Consecutive patients undergoing robotic-assisted single-site hysterectomy from February 2014 to August 2015 at Dong San Hospital, Keimyung University were included. Surgeons used two barbed sutures in a running fashion to close the vaginal cuff. A barbed suture was exclusively used with a straightened needle in upward direction from posterior vaginal cuff to anterior vaginal cuff which played a pivotal role for closure. A total of 100 patients underwent robotic-assisted single-site hysterectomy. The total operation time was 132.5 min and vaginal cuff closure time was 12.0 min. There were no postoperative complications; vaginal cuff dehiscence, vaginal cuff infection, and vaginal bleeding that require surgical intervention or admission. The use of barbed suture with straightened needle to close the vaginal cuff in robotic-assisted single-site hysterectomy is easy to perform and demonstrates safety and efficacy. This technique offers secure, fast, and effective incision closure.

[Percutaneous closure of atrial septal defects with the Amplatzer® device: 15 years of experience].

PubMed

Zabal-Cerdeira, Carlos; García-Montes, José Antonio; Sandoval-Jones, Juan Pablo; Calderón-Colmenero, Juan; Patiño-Bahena, Emilia; Juanico-Enríquez, Antonio; Buendía-Hernández, Alfonso

2014-01-01

Percutaneous closure of atrial septal defects is an alternative to surgical treatment. We report the results of percutaneous closure of atrial septal defects with the Amplatzer(®) device. We include patients taken to the catheterization laboratory from September 1997 to December 2011. We proceeded with defect closure in 721 patients and in 85 the defect was considered not suitable for closure. The stretched diameter of the defect was 23±6.7mm (limits, 5-42). All devices were positioned successfully. In 15 cases (2.1%) the device was changed due to instability and in 6 (0.8%) the device embolized within the first 24h, 4 were retrieved and repositioned (final success with intention to treat 719/806-89.2%). Immediate control showed complete closure in 247 patients (34.3%), leak through the device in 395 (54.9%), mild residual leak in 75 (10.4%) and moderate in 2 (0.3%). We have follow-up in 626 patients (87.1%) for 33±27.5 months, with headache in 54 (8.6%), new supraventricular arrhythmia in 10 (1.6%), puncture site complications in 4 (0.6%), and stroke in one (0.1%). The design of the Amplatzer(®) device allows effective closure of atrial septal defects with a simple technique and patient safety. Copyright © 2013 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

Transcatheter closure of post-operative residual ventricular septal defect using a patent ductus arteriosus closure device in an adult: a case report.

PubMed

Djer, Mulyadi M; Idris, Nikmah S; Alwi, Idrus; Wijaya, Ika P

2014-07-01

Transcatheter closure of perimembranous and muscular ventricular septal defect (VSD) has been performed widely and it has more advantages compare to surgery. However, transcatheter closure of residual VSD post operation of complex congenital heart disease is still challenging because of the complexity of anatomy and concern about device stability, so the operator should meticulously choose the most appropriate technique and device. We would like to report a case of transcatheter closure of residual VSD post Rastelli operation in a patient with double outlet right ventricle (DORV), sub-aortic VSD, severe infundibulum pulmonary stenosis (PS) and single coronary artery. The patient had undergone operations for four times, but he still had intractable heart failure that did not response to medications. On the first attempt. we closed the VSD using a VSD occluder, unfortunately the device embolized into the descending aorta, but fortunately we was able to snare it out. Then we decided to close the VSD using a patent ductus arteriosus (PDA occluder). On transesophageal echocardiography (TEE) and angiography evaluation, the device position was stable. Post transcatheter VSD closure, the patient clinical condition improved significantly and he could finally be discharged after a long post-surgery hospitalization. Based on this experience we concluded that the transcatheter closure of residual VSD in complex CHD using PDA occluder could be an effective alternative treatment.

Hidden (end-on) patent ductus arteriosus: recognition and device closure.

PubMed

Garg, Naveen; Madan, Bevunahalli Kantharaj

2016-02-01

Sometimes, it is difficult to visualize a patent ductus arteriosus and deploy a device in the standard lateral view because of an end-on orientation. The right anterior oblique view may be helpful by separating the ductus arteriosus from the aorta. This study was undertaken to evaluate the incidence of end-on patent ductus arteriosus and the utility of the right anterior oblique view during device closure. Aortography was performed in lateral and right anterior oblique views before, during, and after successful device deployment in 117 consecutive patients. When a ductus arteriosus was not clearly visible in the lateral view due to overlapping by the aorta, it was termed "right anterior oblique view useful". The types of patent ductus arteriosus were A, B, C, and E in 86 (73.5%), 20 (17.1%), 4 (3.4%), and 7 (6.0%) patients, respectively. An end-on ductus arteriosus was present in 24 (20.5%) patients (14 type B, 10 type A). The right anterior oblique view was useful during device closure in 15 (12.8%) cases (all end-on type). Among all cases of end-on patent ductus arteriosus, it was useful in 62.5% (most type B and a few type A). In all of these, the device appeared obliquely oriented and foreshortened in the lateral view but fully profiled in the right anterior oblique view. Recognizing an end-on patent ductus arteriosus and utilizing the right anterior oblique view simplified device closure. For ducts well-profiled in the lateral view, the right anterior oblique view is unnecessary and avoidable. © The Author(s) 2016.

The Use of Vacuum-Assisted Closure and GranuFoam Silver® Dressing in the Management of Diabetic Foot Ulcer.

PubMed

Günal, Özgür; Tuncel, Umut; Turan, Aydin; Barut, Sener; Kostakoglu, Naci

2015-10-01

The aim of this retrospective study was to evaluate the efficacy of vacuum-assisted closure (VAC) and GranuFoam Silver® dressing (KCI, San Antonio, TX) compared with conventional GranuFoam® dressing in the management of diabetic foot ulcers. Twenty-one consecutive patients treated with conventional or silver-coated foam dressing were reviewed retrospectively. The wound duration was 6 mo. Group 1 (n=10) received conventional foam dressing (GranuFoam) and group 2 (n=11) received silver-coated foam dressing (GranuFoam Silver). The wound surface area, duration of treatment, bacteriology, and recurrence were compared between the groups. The mean age of the patients was 61.70±10.52 y in group 1 and 67.27±11.28 y in group 2. In group 1, the average surface area of the wounds was 45.30±46.96 cm2 and 18.40±23.48 cm2 in the pre-treatment and post-treatment periods, respectively. There was a statistically significant difference between two measurements (p=0.005). Average duration of the treatment was 25.50±27.13 d in this group. In group 2, average surface area of the wounds in the pre-treatment and post-treatment periods were 41.55±36.03 cm2 and 7.64±3.91 cm2, respectively. There was a statistically significant difference between two measurements (p=0.003). Average duration of the treatment was 10.09±3.51 d in this group. The patients treated with silver-impregnated polyurethane foam dressing had reduced recurrence (2 vs. 7 wounds, p=0.030) and increased number of the culture-negative cases at the end of the treatment. With the results of the study, it was concluded that VAC GranuFoam silver dressing can be superior to conventional GranuFoam dressing in reducing the recurrence rate of infected diabetic foot ulcers.

Device closure of secundum atrial septal defect's and the risk of cardiac erosion.

PubMed

Thomson, J D R; Qureshi, S A

2015-12-01

Cardiac erosion related to transcatheter atrial septal defect closure devices is of increasing concern. Erosion is reported to have occurred with most of currently available occluder devices. Perhaps due to the very large number of implants worldwide, the Amplatzer (St Jude) occluder is associated with the majority of cardiac erosion events reported in the literature. Best current estimates of the incidence of erosion with the St Jude device are between one and three cases per 1000 implants. Most events occur early after implantation and it is rare, although not unheard of, for events to occur after a year following device insertion. It is important that those involved with closure programmes are vigilant for the problem, because device-related erosion is associated with a significant mortality risk. Despite considerable debate, the risk factors (either patient or device) for erosion remain unclear and require further investigation. Currently available data sets have focussed largely on erosion cohorts and are unable to place these cases in appropriate context with non-erosion closure cases. What is certain is that programmes implanting these devices must take care to implant appropriately sized devices and have in place plans to ensure that patients are both well informed and can access help and advice in the event of developing symptoms.

The Flatstent versus the conventional umbrella devices in the percutaneous closure of patent foramen ovale.

PubMed

Aral, Mert; Mullen, Michael

2015-05-01

Patent foramen ovale (PFO) has been associated with paradoxical embolism leading to stroke/transient ischemic attack, migraine, and neurological decompression sickness. In search for the optimal device that would achieve effective clinical closure with minimal complications, a better device selection based on PFO anatomy and improvements in device design is needed. The Flatstent is a new device designed to treat the highly prevalent long-tunnel PFOs from within, minimizing the amount of material left behind in an attempt to reduce device-related complications. The objective is to compare the safety and efficacy of the novel Flatstent versus the conventional umbrella devices in the transcatheter closure of PFO in a nonrandomized, retrospective, single-center study. Between March 2010 and March 2013, 88 patients underwent PFO closure at The Heart Hospital, London with either the novel Flatstent or one of the four conventionally used umbrella devices (GORE Helex Septal Occluder, Occlutech Figulla Flex, Biostar Septal Occluder, and Amplatzer PFO Occluder) depending on their PFO anatomy. Patients were then evaluated with contrast transthoracic echocardiography (TTE) and/or transoesophageal echocardiography (TOE) at 6 weeks and 1 year after the procedure. The residual shunt and complication rates between the Flatstent and umbrella devices were compared. The Flatstent was used in 27 patients (30.7%), whereas 61 patients (69.3%) received one of the four umbrella devices. Primary efficacy point of clinical closure defined as grade 0 or grade 1; residual shunt was achieved in 81.3% in the Flatstent cohort and 80.3% in the umbrella device group at 6 weeks follow-up. At 1 year, the clinical closure rates reached 92.6 and 91.8%. There were two device embolizations, one in each cohort during the immediate postoperative period (<24 hrs), with successful retrieval. One patient in the umbrella device group developed transient atrial fibrillation, which was controlled medically

Risk factors for anal sphincter tears in vacuum-assisted delivery.

PubMed

Ryman, P; Ahlberg, M; Ekéus, C

2015-10-01

The aim of the present study was to describe the prevalence of anal sphincter tears (AST) in relation to obstetric management and technique during vacuum extraction deliveries (VE) (re: indications, the station of the fetal head at application of the cup, number of tractions, the length for the extraction, cup detachments, pain relief, episiotomy, fetal presentation, and experience of the operator) as well as maternal and infant anthropometrics. Descriptive study. Data on six hundred vacuum extraction deliveries were consecutively collected from six different delivery units in Sweden. Each unit contributed with data on 100 deliveries. The final study population included 596 women who delivered by vacuum extraction. There was no correlation between the management of the vacuum extraction and risk for anal sphincter tear. Women from Africa had nearly a fourfold risk for anal sphincter tear during vacuum-assisted delivery compared with Swedish-born women (OR 3.82 CI 1.47-9.89). Compared with infants with birth weight less than 4000 g, birth weight above 4000 g was associated with increased risk of AST (OR 1.87 CI 1.06-3.28). In this study, the obstetric management in VE-assisted deliveries did not impact the risk of AST. Copyright © 2015 Elsevier B.V. All rights reserved.

Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.

PubMed

Simonetti, Andrea; Amari, Filippo

2015-01-01

In reaction to the limitations of the traditional sterility test methods, in 2008, the U.S. Food and Drug Administration issued the guidance "Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products" encouraging sterile drug manufacturers to use properly validated physical methods, apart from conventional microbial challenge testing, to confirm container closure integrity as part of the stability protocol. The case study presented in this article investigated the capability of four container closure integrity testing methods to detect simulated defects of different sizes and types on glass syringes, prefilled both with drug product intended for parenteral administration and sterile water. The drug product was a flu vaccine (Agrippal, Novartis Vaccines, Siena, Italy). Vacuum decay, pharmacopoeial dye ingress test, Novartis specific dye ingress test, and high-voltage leak detection were, in succession, the methods involved in the comparative studies. The case study execution was preceded by the preparation of two independent sets of reference prefilled syringes, classified, respectively, as examples of conforming to closure integrity requirements (negative controls) and as defective (positive controls). Positive controls were, in turn, split in six groups, three of with holes laser-drilled through the prefilled syringe glass barrel, while the other three with capillary tubes embedded in the prefilled syringe plunger. These reference populations were then investigated by means of validated equipment used for container closure integrity testing of prefilled syringe commercial production; data were collected and analyzed to determine the detection rate and the percentage of false results. Results showed that the vacuum decay method had the highest performance in terms of detection sensitivity and also ensured the best reliability and repeatability of measurements. An innovative technical

Ventricular assist devices in pediatrics

PubMed Central

Fuchs, A; Netz, H

2001-01-01

The implantation of a mechanical circulatory device for end-stage ventricular failure is a possible therapeutic approach in adult and pediatric cardiac surgery and cardiology. The aim of this article is to present mechanical circulatory assist devices used in infants and children with special emphasis on extracorporeal membrane oxygenation, Berlin Heart assist device, centrifugal pump and Medos assist device. The success of long-term support with implantable ventricular assist devices in adults and children has led to their increasing use as a bridge to transplantation in patients with otherwise non-treatable left ventricular failure, by transforming a terminal phase heart condition into a treatable cardiopathy. Such therapy allows rehabilitation of patients before elective cardiac transplantation (by removing contraindications to transplantation mainly represented by organ impairment) or acting as a bridge to recovery of the native left ventricular function (depending on underlying cardiac disease). Treatment may also involve permanent device implantation when cardiac transplantation is contraindicated. Indications for the implantation of assisted circulation include all states of cardiac failure that are reversible within a variable period of time or that require heart transplantation. This article will address the current status of ventricular assist devices by examining historical aspects of its development, current technical issues and clinical features of pediatric ventricular assist devices, including indications and contraindications for support. PMID:22368605

Cermet insert high voltage holdoff improvement for ceramic/metal vacuum devices

DOEpatents

Ierna, W.F.

1986-03-11

An improved metal-to-ceramic seal is provided wherein the ceramic body of the seal contains an integral region of cermet material in electrical contact with the metallic member, e.g., an electrode, of the seal. The seal is useful in high voltage vacuum devices, e.g., vacuum switches, and increases the high-voltage holdoff capabilities of such devices. A method of fabricating such seals is also provided.

Transseptal Guidewire Stabilization for Device Closure of a Large Pulmonary Arteriovenous Malformation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Joseph, George, E-mail: joseph59@gmail.com; Kunwar, Brajesh Kumar, E-mail: kunwar_brajesh@yahoo.com

A 46-year-old man presenting with massive hemoptysis was found to have a large pulmonary arteriovenous malformation (PAVM) in the right lung. Closure of the PAVM with an Amplatzer-type duct occluder was hampered by inability to advance the device delivery sheath into the PAVM due to vessel tortuosity and inadequate guidewire support. Atrial septal puncture was performed and a femorofemoral arteriovenous guidewire loop through the right pulmonary artery, PAVM, and left atrium was created. Traction on both ends of the guidewire loop allowed advancement of the device delivery sheath into the PAVM and successful completion of the procedure. Transseptal guidewire stabilizationmore » can be a valuable option during device closure of large PAVMs when advancement, stability, or kinking of the device delivery sheath is an issue.« less

Systems and Methods for Fabricating Carbon Nanotube-Based Vacuum Electronic Devices

NASA Technical Reports Server (NTRS)

Manohara, Harish (Inventor); Toda, Risaku (Inventor); Del Castillo, Linda Y. (Inventor); Murthy, Rakesh (Inventor)

2015-01-01

Systems and methods in accordance with embodiments of the invention proficiently produce carbon nanotube-based vacuum electronic devices. In one embodiment a method of fabricating a carbon nanotube-based vacuum electronic device includes: growing carbon nanotubes onto a substrate to form a cathode; assembling a stack that includes the cathode, an anode, and a first layer that includes an alignment slot; disposing a microsphere partially into the alignment slot during the assembling of the stack such that the microsphere protrudes from the alignment slot and can thereby separate the first layer from an adjacent layer; and encasing the stack in a vacuum sealed container.

MANTA, a novel plug-based vascular closure device for large bore arteriotomies: technical report.

PubMed

van Gils, Lennart; Daemen, Joost; Walters, Greg; Sorzano, Todd; Grintz, Todd; Nardone, Sam; Lenzen, Mattie; De Jaegere, Peter P T; Roubin, Gary; Van Mieghem, Nicolas M

2016-09-18

Catheter-based interventions have become a less invasive alternative to conventional surgical techniques for a wide array of cardiovascular diseases but often create large arteriotomies. A completely percutaneous technique is attractive as it may reduce the overall complication rate and procedure time. Currently, large bore arteriotomy closure relies on suture-based techniques. Access-site complications are not uncommon and often seem related to closure device failure. The MANTA VCD is a novel collagen-based closure device that specifically targets arteriotomies between 10 and 22 Fr. This technical report discusses the MANTA design concept, practical instructions for use and preliminary clinical experience.

Transcatheter closure of large patent ductus arteriosus using custom made devices.

PubMed

Rohit, Manoj Kumar; Gupta, Ankur

2017-05-01

There has been a paradigm shift in the transcatheter closure of patent ductus arteriosus (PDA) over the last 45 years. With the availability of various coils, plugs and occluders, PDA of almost all shapes and sizes are amenable to transcatheter closure. However, very large PDA diagnosed late in life are being referred for surgical closure in the absence of availability of large size devices, especially in developing countries. In this case series, we have described four patients with large PDA, three of which were closed by transcatheter custom made PDA occluders. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

Transcatheter closure of the left atrial appendage: initial experience with the WATCHMAN device

PubMed Central

Ding, Jiandong; Zhu, Jian; Lu, Jing; Ding, Xiuxia; Zhang, Xiaoli; Lu, Wenbin; Ao, Mingqiang; Ma, Genshan

2015-01-01

Background: Atrial fibrillation (AF) is the most commonly encountered clinical arrhythmia, accounting for approximately one third of hospitalizations for cardiac rhythm disturbance. In patients with non-valvular AF, approximately 90% of thrombi are thought to arise from the left atrial appendage (LAA). Anticoagulation with warfarin has been the mainstay of therapy to reduce stroke risk in these patients; however, it is not without its complications including bleeding and drug interactions. Percutaneous left atrial appendage closure can be an alternative to warfarin treatment in patients with AF at high risk for thromboembolic events and/or bleeding complications. Methods: Patients with atrial fibrillation and CHADSVASc score ≥ 2, not eligible for anticoagulation, were submitted to left atrial appendage closure using the WATCHMAN device. The procedure was performed under general anaesthesia, and was guided by fluoroscopy and transoesophageal echocardiography. Results: Percutaneous LAA closure with the WATCHMAN device was performed in all patients. At 45-day follow-up no recurrent major adverse events and especially no thromboembolic events occurred. Conclusions: Transcatheter closure of the LAA with the WATCHMAN device is generally safe and feasible. Long-term follow-up will further reveal the risk and benefits of this therapy. PMID:26629008

The cost effectiveness of vacuum-assisted versus core-needle versus surgical biopsy of breast lesions.

PubMed

Fernández-García, P; Marco-Doménech, S F; Lizán-Tudela, L; Ibáñez-Gual, M V; Navarro-Ballester, A; Casanovas-Feliu, E

To determine the cost effectiveness of breast biopsy by 9G vacuum-assisted guided by vertical stereotaxy or ultrasonography in comparison with breast biopsy by 14G core-needle biopsy and surgical biopsy. We analyzed a total of 997 biopsies (181 vacuum-assisted, 626 core, and 190 surgical biopsies). We calculated the total costs (indirect and direct) of the three types of biopsy. We did not calculate intangible costs. We measured the percentage of correct diagnoses obtained with each technique. To identify the most cost-effective option, we calculated the mean ratios for the three types of biopsies. Total costs were €225.09 for core biopsy, €638.90 for vacuum-assisted biopsy, and €1780.01 for surgical biopsy. The overall percentage of correct diagnoses was 91.81% for core biopsy, 94.03% for vacuum-assisted biopsy, and 100% for surgical biopsy; however, these differences did not reach statistical significance (p=0.3485). For microcalcifications, the percentage of correct diagnoses was 50% for core biopsy and 96.77% for vacuum-assisted biopsy (p<0.0001). For nodules, there were no significant differences among techniques. The mean cost-effectiveness ratio considering all lesions was 2.45 for core biopsy, 6.79 for vacuum-assisted biopsy, and 17.80 for surgical biopsy. Core biopsy was the dominant option for the diagnosis of suspicious breast lesions in general. However, in cases with microcalcifications, the low percentage of correct diagnoses achieved by core biopsy (50%) advises against its use in this context, where vacuum-assisted biopsy would be the technique of choice because it is more cost-effective than surgical biopsy, the other technique indicated for biopsying microcalcifications. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Atrial septum defect closure device in a beating heart, from the perspective of a researcher in artificial organs.

PubMed

Tomizawa, Yasuko

2012-12-01

Transcatheter closure of atrial septum defect (ASD) with a closure device is increasing, but the history of clinical use of this procedure is still short, and the efficacy and long-term safety remain unproved. The total number of closure devices implanted throughout the world has not been counted accurately. Therefore, the probability of complications occurring after implantation is uncertain. Device-related complications that occur suddenly late after implantation are life-threatening, and quite often necessitate emergency surgical intervention. In Japanese medical journals, authors reporting closure devices have mentioned no complications and problems in their facilities. Detailed studies of device-related complications and device removal have not been reported in Japan. In fact, this literature search found an unexpectedly large number of reports of various adverse events from many overseas countries. When follow-up duration is short and the number of patients is small, the incidence of complications cannot be determined. Rare complications may emerge in a large series with a long observation period. Consequently, the actual number of incidents related to ASD closure devices is possibly several times higher than the number reported. Guidelines for long-term patient management for patients with an implanted closure device are necessary and post-marketing surveillance is appropriate. Development of a national database, a worldwide registration system, and continuous information disclosure will improve the quality of treatment. The devices currently available are not ideal in view of reports of late complications requiring urgent surgery and the need for life-long follow-up. An ideal device should be free from complications during life, and reliability is indispensable.

Port closure techniques.

PubMed

Shaher, Z

2007-08-01

Laparoscopic trocars do create wounds. This article aims to review and list different techniques used for closure of the fascia incision at trocar sites. A literature search was performed for articles dealing with closure techniques. The author searched this subject in English on Medline by combining the words "trocar" and "hernia," as well as "Deschamps" and "Reverdin." All articles reporting techniques with their references were reviewed. The articles described many techniques in addition to classical closure using curved needles, including Grice needle, Maciol needles, Endoclose device, Carter-Thomason device, Tahoe ligature device, Endo-Judge device, eXit puncture closure device, Lowsley retractor, spinal cord needles, dual hemostat, suture carrier, Riverdin and Deschamps needles, and Gore-Tex closure device. Three main groups of techniques were found with favor of extracorporeal manipulations under direct visualization. Old methods are sufficient and cost-effective.

21. Engine identified as a 'single cylinder vacuum assist engine ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

21. Engine identified as a 'single cylinder vacuum assist engine for Tod tandem compound engine' showing compressor. - Carnegie Steel-Ohio Works, Steam Engines, 912 Salt Springs Road, Youngstown, Mahoning County, OH

Challenges in device closure of a large patent ductus arteriosus in infants weighing less than 6 kg.

PubMed

Vijayalakshmi, I B; Chitra, Narasimhan; Praveen, Jayan; Prasanna, Simha Rao

2013-02-01

Transcatheter closure of patent ductus arteriosus (PDA) has replaced surgery in most institutions. Despite improvements in techniques and the devices available, closure of large PDA in very small infants remains a challenge. To assess the challenges, feasibility, and efficacy of device closure of large PDA, in infants weighing ≤6 kg. Analysis of device closure of a PDA was done in 61 infants ≤6 kg. Their ages, ranged from 9 days-12 months (mean 8.9 months), weight ranged from 2.2 to 6 kg (mean 5.3 kg), and PDA measured 3.2-8.7 mm (mean 4.8 mm). The fluoroscopy time was 3-18 minutes. The largest device used was 12 × 10 mm. Successful device placement was achieved in 60/61 infants (98.4%). Mild aortic obstruction occurred in 2 cases (3.3%), as the device got displaced towards the aorta after release. The device embolized in 2 cases (3.3%). In one it was retrieved by a novel method like fastening the screw in the aorta and was closed with a 4 × 6 ADO II. In the other infant, with a single kidney, died of uremia after device retrieval. Mild left pulmonary artery (LPA) obstruction occurred in one case (1.6%). Four cases (6.6%) had minor vascular complications. The postprocedure weight gain after 3 months was between 2.5 kg ± 250 mg. Device closure of large PDA in infants weighing ≤6 kg with left ventricular failure is challenging but possible, safe and effective. Retrieval of embolized device could be tricky. © 2012, Wiley Periodicals, Inc.

Use of Vacuum Bagging for Fabricating Thermoplastic Microfluidic Devices

PubMed Central

Cassano, Christopher L.; Simon, Andrew J.; Liu, Wei; Fredrickson, Carl; Fan, Z. Hugh

2014-01-01

In this work we present a novel thermal bonding method for thermoplastic microfluidic devices. This simple method employs a modified vacuum bagging technique, a concept borrowed from the aerospace industry, to produce conventional thick substrate microfluidic devices, as well as multi-layer film devices. The bonds produced using this method are superior to those obtained using conventional thermal bonding methods, including thermal lamination, and are capable of sustaining burst pressures in excess of 550 kPa. To illustrate the utility of this method, thick substrate devices were produced, as well as a six-layer film device that incorporated several complex features. PMID:25329244

Preliminary experience with a new device for delayed sternal closure strategy in cardiac surgery.

PubMed

Santini, Francesco; Onorati, Francesco; Telesca, Mariassunta; Faggian, Giuseppe; Mazzucco, Alessandro

2012-06-01

Open chest management with delayed sternal closure (DSC) is a valuable strategy in the management of patients with postcardiotomy hemodynamic instability or severe coagulopathy. The conventional extemporized material available for off-label sternal stenting however may limit its efficacy. We evaluated outcomes of patients with refractory severe postcardiotomy cardiogenic shock (SPCCS) treated with DSC using a novel temporary sternal spreader (NTSS) which allows myocardial recovery by progressive controlled approximation of the sternal edges. Seven patients (4 male, mean age 66.5 ± 5 years) with refractory SPCCS showing acute hemodynamic instability at sternal closure, were implanted with the NTSS, consisting of stainless-steel branches linked to 2 diverging plates of polyether-ether ketone, whose progressive opening/closing mechanism can be controlled from outside the chest with a rotating steel wire. The sternal wound was closed by an elastic membrane to achieve a sterile field. Swan-Ganz monitoring was employed, and clinical outcomes evaluated. The device was successfully implanted in all patients without device-related complications or failures. Progressive approximation of sternal edges, titrated on cardiac index values, was successfully completed allowing subsequent uneventful sternal closure in all. Mean time from SPCCS to sternal closure was 70 ± 21 hours. No patient developed infective complications or late hemodynamic instability after device removal and sternal closure. One patient (14%) died of multiorgan failure on postoperative day 9. Despite the limited number of patients enrolled, the NTSS proved safe and effective in allowing complete myocardial recovery after SPCCS, avoiding hemodynamic instability related to abrupt sternal closure, with no occurrence of infective complications.

Performance characteristics of a novel blood bag in-line closure device and subsequent product quality assessment

PubMed Central

Serrano, Katherine; Levin, Elena; Culibrk, Brankica; Weiss, Sandra; Scammell, Ken; Boecker, Wolfgang F; Devine, Dana V

2010-01-01

BACKGROUND In high-volume processing environments, manual breakage of in-line closures can result in repetitive strain injury (RSI). Furthermore, these closures may be incorrectly opened causing shear-induced hemolysis. To overcome the variability of in-line closure use and minimize RSI, Fresenius Kabi developed a new in-line closure, the CompoFlow, with mechanical openers. STUDY DESIGN AND METHODS The consistency of the performance of the CompoFlow closure device was assessed, as was its effect on component quality. A total of 188 RBC units using CompoFlow blood bag systems and 43 using the standard bag systems were produced using the buffy coat manufacturing method. Twenty-six CompoFlow platelet (PLT) concentrates and 10 control concentrates were prepared from pools of four buffy coats. RBCs were assessed on Days 1, 21, and 42 for cellular variables and hemolysis. PLTs were assessed on Days 1, 3, and 7 for morphology, CD62P expression, glucose, lactate, and pH. A total of 308 closures were excised after processing and the apertures were measured using digital image analysis. RESULTS The use of the CompoFlow device significantly improved the mean extraction time with 0.46 ± 0.11 sec/mL for the CompoFlow units and 0.52 ± 0.13 sec/mL for the control units. The CompoFlow closures showed a highly reproducible aperture after opening (coefficient of variation, 15%) and the device always remained opened. PLT and RBC products showed acceptable storage variables with no differences between CompoFlow and control. CONCLUSIONS The CompoFlow closure devices improved the level of process control and processing time of blood component production with no negative effects on product quality. PMID:20529007

20. Engine identified as a 'single cylinder vacuum assist engine ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

20. Engine identified as a 'single cylinder vacuum assist engine for the Tod tandem compound engine' showing crank end. - Carnegie Steel-Ohio Works, Steam Engines, 912 Salt Springs Road, Youngstown, Mahoning County, OH

19. Engine identified as a single cylinder vacuum assist engine ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

19. Engine identified as a single cylinder vacuum assist engine for the Filer and Stowell 15-inch continuous mill. - Carnegie Steel-Ohio Works, Steam Engines, 912 Salt Springs Road, Youngstown, Mahoning County, OH

Effects of nanoscale vacuum gap on photon-enhanced thermionic emission devices

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wang, Yuan; Liao, Tianjun; Zhang, Yanchao

2016-01-28

A new model of the photon-enhanced thermionic emission (PETE) device with a nanoscale vacuum gap is established by introducing the quantum tunneling effect and the image force correction. Analytic expressions for both the thermionic emission and tunneling currents are derived. The electron concentration and the temperature of the cathode are determined by the particle conservation and energy balance equations. The effects of the operating voltage on the maximum potential barrier, cathode temperature, electron concentration and equilibrium electron concentration of the conduction band, and efficiency of the PETE device are discussed in detail for different given values of the vacuum gapmore » length. The influence of the band gap of the cathode and flux concentration on the efficiency is further analyzed. The maximum efficiency of the PETE and the corresponding optimum values of the band gap and the operating voltage are determined. The results obtained here show that the efficiency of the PETE device can be significantly improved by employing a nanoscale vacuum gap.« less

Traction-assisted Internal Negative Pressure Wound Therapy With Bridging Retention Sutures to Facilitate Staged Closure of High-risk Wounds Under Tension.

PubMed

DeFazio, Michael V; Economides, James M; Anghel, Ersilia L; Mathis, Ryan K; Barbour, John R; Attinger, Christopher E

2017-10-01

Loss of domain often complicates attempts at delayed wound closure in regions of high tension. Wound temporization with traction-assisted internal negative pressure wound therapy (NPWT), using bridging retention sutures, can minimize the effects of edema and elastic recoil that contribute to progressive tissue retraction over time. The investigators evaluated the safety and efficacy of this technique for complex wound closure. Between May 2015 and November 2015, 18 consecutive patients underwent staged reconstruction of complex and/or contaminated soft tissue defects utilizing either conventional NPWT or modified NPWT with instillation and continuous dermatotraction via bridging retention sutures. Instillation of antimicrobial solution was reserved for wounds containing infected/exposed hardware or prosthetic devices. Demographic data, wound characteristics, reconstructive outcomes, and complications were reviewed retrospectively. Eighteen wounds were treated with traction-assisted internal NPWT using the conventional (n = 11) or modified instillation (n = 7) technique. Defects involved the lower extremity (n = 14), trunk (n = 3), and proximal upper extremity (n = 1), with positive cultures identified in 12 wounds (67%). Therapy continued for 3 to 8 days (mean, 4.3 days), resulting in an average wound surface area reduction of 78% (149 cm² vs. 33 cm²) at definitive closure. Seventeen wounds (94%) were closed directly, whereas the remaining defect required coverage with a local muscle flap and skin graft. At final follow-up (mean, 12 months), 89% of wounds remained closed. In 2 patients with delayed, recurrent periprosthetic infection (mean, 7.5 weeks), serial debridement/hardware removal mandated free tissue transfer for composite defect reconstruction. Traction-assisted internal NPWT provides a safe and effective alternative to reduce wound burden and facilitate definitive closure in cases where delayed reconstruction of high-tension wounds is planned.

MAGNETIC END CLOSURES FOR PLASMA CONFINING AND HEATING DEVICES

DOEpatents

Post, R.F.

1963-08-20

More effective magnetic closure field regions for various open-ended containment magnetic fields used in fusion reactor devices are provided by several spaced, coaxially-aligned solenoids utilized to produce a series of nodal field regions of uniform or, preferably, of incrementally increasing intensity separated by lower intensity regions outwardly from the ends of said containment zone. Plasma sources may also be provided to inject plasma into said lower intensity areas to increase plasma density therein. Plasma may then be transported, by plasma diffusion mechanisms provided by the nodal fields, into the containment field. With correlated plasma densities and nodal field spacings approximating the mean free partl cle collision path length in the zones between the nodal fields, optimum closure effectiveness is obtained. (AEC)

Comparative study of abdominal cavity temporary closure techniques for damage control.

PubMed

Ribeiro, Marcelo A F; Barros, Emily Alves; Carvalho, Sabrina Marques DE; Nascimento, Vinicius Pereira; Cruvinel, José; Fonseca, Alexandre Zanchenko

2016-01-01

The damage control surgery, with emphasis on laparostomy, usually results in shrinkage of the aponeurosis and loss of the ability to close the abdominal wall, leading to the formation of ventral incisional hernias. Currently, various techniques offer greater chances of closing the abdominal cavity with less tension. Thus, this study aims to evaluate three temporary closure techniques of the abdominal cavity: the Vacuum-Assisted Closure Therapy - VAC, the Bogotá Bag and the Vacuum-pack. We conducted a systematic review of the literature, selecting 28 articles published in the last 20 years. The techniques of the bag Bogotá and Vacuum-pack had the advantage of easy access to the material in most centers and low cost, contrary to VAC, which, besides presenting high cost, is not available in most hospitals. On the other hand, the VAC technique was more effective in reducing stress at the edges of lesions, removing stagnant fluids and waste, in addition to acting at the cellular level by increasing proliferation and cell division rates, and showed the highest rates of primary closure of the abdominal cavity. RESUMO A cirurgia de controle de danos, com ênfase em peritoneostomia, geralmente resulta em retração da aponeurose e perda da capacidade de fechar a parede abdominal, levando à formação de hérnias ventrais incisionais. Atualmente, várias técnicas oferecem maiores chances de fechamento da cavidade abdominal, com menor tensão. Deste modo, este estudo tem por objetivo avaliar três técnicas de fechamento temporário da cavidade abdominal: fechamento a vácuo (Vacuum-Assisted Closure Therapy - VAC), Bolsa de Bogotá e Vacuum-pack. Realizou-se uma revisão sistemática da literatura com seleção de 28 artigos publicados nos últimos 20 anos. As técnicas de Bolsa de Bogotá e Vacuum-pack tiveram como vantagem o acesso fácil ao material, na maioria dos centros, e baixo custo, ao contrário do que se observa na terapia a vácuo, VAC, que além de apresentar

Safety and feasibility of intra-operative device closure of atrial septal defect with transthoracic minimal invasion.

PubMed

Chen, Qiang; Cao, Hua; Zhang, Gui-Can; Chen, Liang-Wan; Chen, Dao-Zhong

2012-01-01

The study aims to evaluate the safety and feasibility of intra-operative device closure of atrial septal defect with transthoracic minimal invasion. From May 2006 to June 2009, 252 patients with secundum-type atrial septal defect closure were enrolled in our institution. The patients were divided into two groups, with 182 patients in group I with intra-operative device closure and 72 in group II with surgical closure. In group I, the patients' age ranged from 3 months to 62 years (mean±standard deviation, 19.0±16.7 years). This approach involved a transthoracic minimal invasion that was performed after full evaluation of the atrial septal defect by transthoracic echocardiography, deploying the device through the delivery sheath to occlude the atrial septal defect. In group I, 180 patients were occluded successfully under this approach. The size of the occluder device implanted ranged from 6 to 48 mm. Minor complications occurred, which included transient arrhythmias (n=23) and pleural effusion (n=15). Two patients with postoperative cardiac arrest were successfully cardiopulmonary resuscitated. Another two patients with occluder dislodged back into the right atrium were turned to surgical repair with cardiopulmonary bypass on the postoperative day. In group II, all patients were occluded successfully, and almost all patients needed blood transfusion and suffered from various minor complications. All discharged patients were followed up for 1-5 years. During this period, we found no recurrence, no thrombosis, even no device failure. In our comparative studies, group II had significantly longer intensive care unit (ICU) stay and hospital stay than group I (p<0.05). The cost for group I was less than group II (p<0.05). Intra-operative device closure of atrial septal defect with transthoracic minimal invasion is a safe and feasible technique. It had the advantages of cost savings, yielding better cosmetic results, and leaving less trauma than surgical closure.

Photolithographic patterning of vacuum-deposited organic light emitting devices

NASA Astrophysics Data System (ADS)

Tian, P. F.; Burrows, P. E.; Forrest, S. R.

1997-12-01

We demonstrate a photolithographic technique to fabricate vacuum-deposited organic light emitting devices. Photoresist liftoff combined with vertical deposition of the emissive organic materials and the metal cathode, followed by oblique deposition of a metal cap, avoids the use of high processing temperatures and the exposure of the organic materials to chemical degradation. The unpackaged devices show no sign of deterioration in room ambient when compared with conventional devices fabricated using low-resolution, shadow mask patterning. Furthermore, the devices are resistant to rapid degradation when operated in air for extended periods. This work illustrates a potential foundation for the volume production of very high-resolution, full color, flat panel displays based on small molecular weight organic light emitting devices.

EVALUATION OF MASS FLUX TO AND FROM GROUND WATER USING A VERTICAL FLUX MODEL (VFLUX): APPLICATION TO THE SOIL VACUUM EXTRACTION CLOSURE PROBLEM

EPA Science Inventory

Site closure for soil vacuum extraction (SVE) application typically requires attainment of specified soil concentration standards based on the premise that mass flux from the vadose zone to ground water not result in levels exceeding maximum contaminant levels (MCLSs). Unfortuna...

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2012 CFR

2012-07-01

... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired... 34 Education 2 2012-07-01 2012-07-01 false Assistive technology device. 300.5 Section 300.5...

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2013 CFR

2013-07-01

... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired... 34 Education 2 2013-07-01 2013-07-01 false Assistive technology device. 300.5 Section 300.5...

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2014 CFR

2014-07-01

... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired... 34 Education 2 2014-07-01 2013-07-01 true Assistive technology device. 300.5 Section 300.5...

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2011 CFR

2011-07-01

... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired... 34 Education 2 2011-07-01 2010-07-01 true Assistive technology device. 300.5 Section 300.5...

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 2 2010-07-01 2010-07-01 false Assistive technology device. 300.5 Section 300.5... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired...

Evaluation of a Prototype Hybrid Vacuum Pump to Provide Vacuum-Assisted Suspension for Above-Knee Prostheses

PubMed Central

Major, Matthew J.; Caldwell, Ryan; Fatone, Stefania

2015-01-01

Vacuum-assisted suspension (VAS) of prosthetic sockets utilizes a pump to evacuate air from between the prosthetic liner and socket, and are available as mechanical or electric systems. This technical note describes a hybrid pump that benefits from the advantages of mechanical and electric systems, and evaluates a prototype as proof-of-concept. Cyclical bench testing of the hybrid pump mechanical system was performed using a materials testing system to assess the relationship between compression cycles and vacuum pressure. Phase 1 in vivo testing of the hybrid pump was performed by an able-bodied individual using prosthesis simulator boots walking on a treadmill, and phase 2 involved an above-knee prosthesis user walking with the hybrid pump and a commercial electric pump for comparison. Bench testing of 300 compression cycles produced a maximum vacuum of 24 in-Hg. In vivo testing demonstrated that the hybrid pump continued to pull vacuum during walking, and as opposed to the commercial electric pump, did not require reactivation of the electric system during phase 2 testing. The novelty of the hybrid pump is that while the electric system provides rapid, initial vacuum suspension, the mechanical system provides continuous air evacuation while walking to maintain suspension without reactivation of the electric system, thereby allowing battery power to be reserved for monitoring vacuum levels. PMID:27462383

[Treatment of septic olecranon and patellar bursitis by excision and vacuum-assisted closure therapy].

PubMed

Walter, G; Kemmerer, M; Hoffmann, R

2013-08-01

Treatment of septic olecranon and patellar bursitis differs considerably and is currently under discussion. We therefore performed a retrospective study of our patients with septic bursitis in the past 5 years. Between March 2007 and February 2012 we treated 79 patients with septic olecranon (n = 43) and patellar (n = 36) bursitis surgically: 61-males, 18 females, age 51 (range: 11-91) years. Four patients had not been treated before, 25 had suffered recurrences after 1-10 previous procedures, and 9 patients had not improved after conservative therapy. 34 patients presented with traumatic rupture or fistula of their bursae. In all cases we performed a radical bursectomy and vacuum-assisted therapy for 4 to 5 days. In addition, patients received systemic antibiotics. We phoned all patients and were successful in 57 cases (72 %). We questioned these patients for range of movement, limitations at work, pain, sensibility disorder, satisfaction with the result and further surgical procedures. In all cases we took tissue specimens for cultures, in 48 preparations histological examination was performed. Microbiological and histological results are discussed in detail. 40 patients were free of complaints, 15 complained of mild pain, 54 of 57 had unlimited range of motion. Minor discomforts at desk work were reported by 5 of 43 patients, 12 out of 36 patient reported discomfort when performing on their knees. There was no recurrence in the period of investigation. We recommend our treatment concept for septic olecranon and patellar bursitis because patient satisfaction is high and recurrences are reliably avoided. The soft tissue is spared, so that plastic covering procedures are seldom necessary. Georg Thieme Verlag KG Stuttgart · New York.

Is adhesive paper-tape closure of video assisted thoracoscopic port-sites safe?

PubMed

Luckraz, Heyman; Rammohan, Kandadai S; Phillips, Mabel; O'Keefe, Peter A

2007-07-01

Video assisted thoracoscopic surgery (VATS) is used in lung surgery for diagnostic, staging, curative and palliative purposes. The port-sites are usually sutured with dissolvable sutures. The use of adhesive paper-tape for port-site closure was assessed by a prospective randomised double-blind control trial comparing sutured to adhesive paper-tape closure. The following outcomes were assessed: incidence of clinically significant pneumothorax, wound healing using the ASEPSIS score, patient's comfort (pain score using a visual analog score), the time difference between the two techniques of wound closure and cost savings. Thirty patients were recruited in each group. No clinically significant pneumothoraces occurred in either group. There were no significant differences between the two groups in terms of immediate post-operative pain scores, wound cosmesis and wound complications. It was quicker to close the wound with adhesive paper-tape with a mean time of closure per unit length of wound of 9.3 and 2.2s/mm for the groups, respectively. The cost for wound closure (per patient) was $0.8 for the adhesive paper-tape group and $4.00 for the sutures.

Treatment with vacuum-assisted closure and cryo-preserved homologous de-epidermalised dermis of complex traumas to the lower limbs with loss of substance, and bones and tendons exposure.

PubMed

Brandi, C; Grimaldi, L; Nisi, G; Silvestri, A; Brafa, A; Calabrò, M; D'Aniello, C

2008-12-01

Lower-limb injuries with loss of tissue and exposure of bones and tendons are an increasing problem. The condition of the wound locally and the patient in general does not always allow immediate and adequate coverage of the structures exposed by the trauma. Therefore, new therapeutic solutions are needed. A reduction in the time that bones and tendons are exposed is essential to achieve complete healing of bone fractures, with reduced risks of infection and less disabling outcomes. The effectiveness of vacuum-assisted closure (VAC) therapy in supporting wound healing and of cryopreserved homologous de-epidermalised dermis (DED) in providing an effective template for re-epithelialisation has been previously reported. We carried out a study to evaluate the effectiveness of the synergistic and combined use of the two methodologies. Eighteen patients with traumatic loss of tissue in the lower limbs, involving exposure of bone and tendon structures, were enrolled in the study. All participants had local, general contraindications to first-instance reconstructions, or both. All patients received a combination of VAC therapy and DED implants. Granulation tissue was obtained in all wounds, with complete coverage of exposed structures. No infections were detected in the cohort, and all patients were prepared for further necessary reconstructive treatments. In our experience, the combination of VAC therapy and DED could, in selected cases, constitute an effective treatment for complex lower limb traumatic injuries with bone and tendon exposure.

Open abdomen in gastrointestinal surgery: Which technique is the best for temporary closure during damage control?

PubMed Central

Ribeiro Junior, Marcelo A F; Barros, Emily Alves; de Carvalho, Sabrina Marques; Nascimento, Vinicius Pereira; Cruvinel Neto, José; Fonseca, Alexandre Zanchenko

2016-01-01

AIM To compare the 3 main techniques of temporary closure of the abdominal cavity, vacuum assisted closure (vacuum-assisted closure therapy - VAC), Bogota bag and Barker technique, in damage control surgery. METHODS After systematic review of the literature, 33 articles were selected to compare the efficiency of the three procedures. Criteria such as cost, infections, capacity of reconstruction of the abdominal wall, diseases associated with the technique, among others were analyzed. RESULTS The Bogota bag and Barker techniques present as advantage the availability of material and low cost, what is not observed in the VAC procedure. The VAC technique is the most efficient, not only because it reduces the tension on the boarders of the lesion, but also removes stagnant fluids and debris and acts at cellular level increasing cell proliferation and division. Bogota bag presents the higher rates of skin laceration and evisceration, greater need for a stent for draining fluids and wash-ups, higher rates of intestinal adhesion to the abdominal wall. The Barker technique presents lack of efficiency in closing the abdominal wall and difficulty on maintaining pressure on the dressing. The VAC dressing can generate irritation and dermatitis when the drape is applied, in addition to pain, infection and bleeding, as well as toxic shock syndrome, anaerobic sepsis and thrombosis. CONCLUSION The VAC technique, showed to be superior allowing a better control of liquid on the third space, avoiding complications such as fistula with small mortality, low infection rate, and easier capability on primary closure of the abdominal cavity. PMID:27648164

Self-expanding platinum-coated nitinol devices for transcatheter closure of atrial septal defect: prevention of nickel release.

PubMed

Lertsapcharoen, Pornthep; Khongphatthanayothin, Apichai; Srimahachota, Suphot; Leelanukrom, Ruenreong

2008-06-01

A variety of nitinol-containing devices for transcatheter closure of atrial septal defects (ASD) has been widely used. However, there is concern about the release of nickel after nitinol device implantation. In this study, a platinum-coated nitinol device was braided from nanoplatinum-coated nitinol wires in order to prevent nickel release. The serum nickel levels before and after device implantation and the 1-year results were evaluated. Thirty-one patients, aged 4-59 years, and weighing 13.7-90.0 kg, underwent transcatheter closure. Blood samples for serum nickel levels were taken before, 1 day, 1 week, 1 month and 3 months after implantation. Twenty-nine (93.6%) patients had a successful implantation. The mean ASD diameter was 19.7 +/- 4.8 mm (range 10-30 mm). Procedure-related complications included transient brachial plexus injury in 1 patient and transient dysrhythmia in 4 patients. All 29 patients had complete closure within 1 month after implantation. The mean serum nickel levels at baseline and at 1 day, 1 week, 1 month and 3 months after implantation were 0.65 +/- 0.28, 0.63 +/- 0.18, 0.67 +/- 0.34, 0.55 +/- 0.16, 0.52 +/- 0.14 ng/ml, respectively. There was no significant difference in serum nickel levels before and after implantation. There were no device-related complications at 1-year follow up. Transcatheter ASD closure using a platinum-coated nitinol device can be performed safely and successfully with good outcomes. Nano-coating of platinum on nitinol wires can prevent nickel release following device implantation.

Prospective Comparison of Collagen Plug (Angio-Seal™) and Suture-Mediated (the Closer S™) Closure Devices at Femoral Access Sites

PubMed Central

Park, Yulri; Choo, Sung Wook; Lee, Sung Hoon; Shin, Sung Wook; Do, Young Soo; Byun, Hong Sik; Park, Kwang Bo; Jeon, Pyoung

2005-01-01

Objective Rapid and effective hemostasis at femoral puncture sites minimizes both the hospital stay and patient discomfort. Therefore, a variety of arterial closure devices have been developed to facilitate the closure of femoral arteriotomy. The objective of this prospective study was to compare the efficacy of two different closure devices; a collagen plug device (Angio-Seal) and a suture-mediated closure device (the Closer S). Materials and Methods From March 28, 2003 to August 31, 2004, we conducted a prospective study in which 1,676 cases of 1,180 patients were treated with two different types of closure device. Angio-Seal was used in 961 cases and the Closer S in 715 cases. The efficacy of the closure devices was assessed, as well as complications occurring at the puncture sites. Results Successful immediate hemostasis was achieved in 95.2% of the cases treated with Angio-Seal, and in 89.5% of the cases treated with the Closer S (p < 0.05). The rates of minor and major complications occurring between the two groups were not significantly different. In the Closer S group, we observed four major complications (0.6%), that consisted of one massive retroperitoneal hemorrhage (surgically explored) and three pseudoaneurysms. In the Angio-Seal group, we observed three major complications (0.3%) that consisted of one femoral artery occlusion, one case of infection treated with intravenous antibiotics and one pseudoaneurysm. Conclusion The use of Angio-Seal was found to be more effective than that of the Closer S with regard to the immediate hemostasis of the femoral puncture sites. However, we detected no significant differences in the rate at which complications occurred. PMID:16374083

Self-expanding nanoplatinum-coated nitinol devices for atrial septal defect and patent ductus arteriosus closure: a swine model.

PubMed

Lertsapcharoen, Pornthep; Khongphatthanayothin, Apichai; La-orkhun, Vidhavas; Supachokchaiwattana, Pentip; Charoonrut, Phingphol

2006-01-01

Our purpose was to evaluate self-expanding nanoplatinum-coated nitinol devices for transcatheter closure of atrial septal defects and patent ductus arteriosus in a swine model. The devices were braided from platinum-activated nitinol wires and filled with polyester to enhance thrombogenicity. The platinum activation of the nitinol wires was carried out with the help of Nanofusion technology. The coating of platinum covers the exposed surface of the nitinol wires and prevents the release of nickel into the blood stream after the implantation of the device but does not affect its shape memory, which makes the device self-expanding after it is loaded from the catheter. Atrial septal defects were created in 12 piglets by balloon dilation of the patent foramen ovale. The size of the device was selected on the basis of the diameter of the balloon and the size of the defect, measured by transthoracic echocardiography. The devices were successfully deployed in all 12 piglets under fluoroscopic study. Transthoracic color Doppler echocardiograms showed complete closure of the atrial septal defect within 15 minutes of device implantation. Twelve patent ductus arteriosus closure devices were deployed in the right or left subclavian arteries in 10 piglets. Angiograms showed complete occlusion of the subclavian arteries within a few minutes of device deployment. In the atrial septal defect cases, the autopsy findings showed complete organizing fibrin thrombus formation and complete neo-endothelialization on the outer surface of the devices within one week and six weeks of implantation, respectively. The use of self-expanding nanoplatinum-coated nitinol devices for the transcatheter closure of atrial septal defects and patent ductus arteriosus is feasible. The excellent occlusion result and complete neo-endothelialization of the devices in the swine model is an indication of the potential of these devices in human application.

Vacuum Microelectronic Field Emission Array Devices for Microwave Amplification.

NASA Astrophysics Data System (ADS)

Mancusi, Joseph Edward

This dissertation presents the design, analysis, and measurement of vacuum microelectronic devices which use field emission to extract an electron current from arrays of silicon cones. The arrays of regularly-spaced silicon cones, the field emission cathodes or emitters, are fabricated with an integrated gate electrode which controls the electric field at the tip of the cone, and thus the electron current. An anode or collector electrode is placed above the array to collect the emission current. These arrays, which are fabricated in a standard silicon processing facility, are developed for use as high power microwave amplifiers. Field emission has been studied extensively since it was first characterized in 1928, however due to the large electric fields required practical field emission devices are difficult to make. With the development of the semiconductor industry came the development of fabrication equipment and techniques which allow for the manufacture of the precision micron-scale structures necessary for practical field emission devices. The active region of a field emission device is a vacuum, therefore the electron travel is ballistic. This analysis of field emission devices includes electric field and electron emission modeling, development of a device equivalent circuit, analysis of the parameters in the equivalent circuit, and device testing. Variations in device structure are taken into account using a statistical model based upon device measurements. Measurements of silicon field emitter arrays at DC and RF are presented and analyzed. In this dissertation, the equivalent circuit is developed from the analysis of the device structure. The circuit parameters are calculated from geometrical considerations and material properties, or are determined from device measurements. It is necessary to include the emitter resistance in the equivalent circuit model since relatively high resistivity silicon wafers are used. As is demonstrated, the circuit model

Alveolar ridge expansion-assisted orthodontic space closure in the mandibular posterior region.

PubMed

Ozer, Mete; Akdeniz, Berat Serdar; Sumer, Mahmut

2013-12-01

Orthodontic closure of old, edentulous spaces in the mandibular posterior region is a major challenge. In this report, we describe a method of orthodontic closure of edentulous spaces in the mandibular posterior region accelerated by piezoelectric decortication and alveolar ridge expansion. Combined piezosurgical and orthodontic treatments were used to close 14- and 15-mm-wide spaces in the mandibular left and right posterior areas, respectively, of a female patient, aged 18 years and 9 months, diagnosed with skeletal Class III malocclusion, hypodontia, and polydiastemas. After the piezoelectric decortication, segmental and full-arch mechanics were applied in the orthodontic phase. Despite some extent of root resorption and anchorage loss, the edentulous spaces were closed, and adequate function and esthetics were regained without further restorative treatment. Alveolar ridge expansion-assisted orthodontic space closure seems to be an effective and relatively less-invasive treatment alternative for edentulous spaces in the mandibular posterior region.

Brain-controlled body movement assistance devices and methods

DOE Office of Scientific and Technical Information (OSTI.GOV)

Leuthardt, Eric C.; Love, Lonnie J.; Coker, Rob

Methods, devices, systems, and apparatus, including computer programs encoded on a computer storage medium, for brain-controlled body movement assistance devices. In one aspect, a device includes a brain-controlled body movement assistance device with a brain-computer interface (BCI) component adapted to be mounted to a user, a body movement assistance component operably connected to the BCI component and adapted to be worn by the user, and a feedback mechanism provided in connection with at least one of the BCI component and the body movement assistance component, the feedback mechanism being configured to output information relating to a usage session of themore » brain-controlled body movement assistance device.« less

Intraoperative device closure of atrial septal defects with inferior vena cava rim deficiency: a safe alternative to surgical repair.

PubMed

Chen, Qiang; Chen, Liang-Wan; Cao, Hua; Zhang, Gui-Can; Chen, Dao-Zhong; Zhang, Hui

2011-03-01

Our objective was to evaluate the safety and feasibility of intraoperative device closure of atrial septal defects with inferior vena cava rim deficiency. From January 2005 to December 2008, we enrolled 65 patients who had a secundum atrial septal defect with inferior vena cava rim deficiency closure in our institution. Patients were divided into 2 groups: 35 patients in group I underwent intraoperative device closure with a right lateral minithoracotomy and 30 in group II underwent open cardiac repair with a right lateral thoracotomy and cardiopulmonary bypass. Intraoperative device closure involved a minimal intercostal incision that was performed after full evaluation of the atrial septal defect by transthoracic echocardiography and the insertion of the device through the delivery sheath to occlude the atrial septal defect. The procedure was successful in all patients. In group I, the diameter of the atrial septal defect ranged from 30 to 44 mm (mean, 35.3 ± 3.9 mm), and the size of the implanted occluder ranged from 34 to 48 mm (mean, 40 ± 2.1 mm). The total occlusion rate was 82.9% immediately after the operation, 97.1% at 3 months, and 100% at 12 and 24 months of follow-up. In group II, all patients had successful closure. A follow-up period of 12 to 24 months was obtained in both groups. During the follow-up, there was no recurrence, thrombosis, or device failure. In our comparative studies, group II had significantly longer operative time, intensive care unit stay, and hospital stay than group I (P < .001). The cost of group I was less than that of group II (20,450.9 ± 840.8 RMB vs 25,884.9 ± 701.8; P < .001). Intraoperative device closure of atrial septal defects with inferior vena cava rim deficiency is a safe and feasible technique. It has the advantages of cost savings, cosmetic results, and less trauma than surgical closure. Early and midterm results are encouraging. Crown Copyright © 2011. Published by Mosby, Inc. All rights reserved.

Vacuum compatible sample positioning device for matrix assisted laser desorption/ionization Fourier transform ion cyclotron resonance mass spectrometry imaging

DOE Office of Scientific and Technical Information (OSTI.GOV)

Aizikov, Konstantin; Lin, Tzu-Yung; Department of Electrical and Computer Engineering, Boston University, Boston, Massachusetts 02215

The high mass accuracy and resolving power of Fourier transform ion cyclotron resonance mass spectrometers (FT-ICR MS) make them ideal mass detectors for mass spectrometry imaging (MSI), promising to provide unmatched molecular resolution capabilities. The intrinsic low tolerance of FT-ICR MS to RF interference, however, along with typically vertical positioning of the sample, and MSI acquisition speed requirements present numerous engineering challenges in creating robotics capable of achieving the spatial resolution to match. This work discusses a two-dimensional positioning stage designed to address these issues. The stage is capable of operating in {approx}1 x 10{sup -8} mbar vacuum. The rangemore » of motion is set to 100 mm x 100 mm to accommodate large samples, while the positioning accuracy is demonstrated to be less than 0.4 micron in both directions under vertical load over the entire range. This device was integrated into three different matrix assisted laser desorption/ionization (MALDI) FT-ICR instruments and showed no detectable RF noise. The ''oversampling'' MALDI-MSI experiments, under which the sample is completely ablated at each position, followed by the target movement of the distance smaller than the laser beam, conducted on the custom-built 7T FT-ICR MS demonstrate the stability and positional accuracy of the stage robotics which delivers high spatial resolution mass spectral images at a fraction of the laser spot diameter.« less

Vascular Closure Devices in Interventional Radiology Practice

DOE Office of Scientific and Technical Information (OSTI.GOV)

Patel, Rafiuddin, E-mail: rafiuddin.patel@ouh.nhs.uk; Muller-Hulsbeck, Stefan, E-mail: muehue@diako.de; Morgan, Robert, E-mail: robert.morgan@stgeorges.nhs.uk

2015-08-15

Manual compression (MC) is a well-established technique for haemostasis following percutaneous arterial intervention. However, MC is labour and time intensive with potential limitations, particularly for patients who are coagulopathic, unable to comply with bed rest or obese and when large sheaths or anti-coagulants are used. There are a variety of vascular closure devices (VCDs) available to overcome these limitations. This review gives an overview of current VCDs, their mechanism of action, individual strengths and weaknesses, evidence base and utility in interventional radiology (IR) practice. The majority of the published evidence on VCDs is derived from patients undergoing cardiac interventions, whichmore » should be borne in mind when considering the applicability and transfer of this data for general IR practice. Overall, the evidence suggests that most VCDs are effective in achieving haemostasis with a similar rate of complications to MC although the complication profile associated with VCDs is distinct to that of MC. There is insufficient evidence to comparatively analyse the different types of VCDs currently available or reliably judge their cost-effectiveness. The interventional radiologist should have a thorough understanding of the available techniques for haemostasis and be able to identify and utilise the most appropriate strategy and closure technique for the individual patient.« less

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 4 2012-10-01 2012-10-01 false Wireless video assist devices. 74.870 Section... Stations § 74.870 Wireless video assist devices. Television broadcast auxiliary licensees and motion picture and television producers, as defined in § 74.801 may operate wireless video assist devices on a...

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 4 2011-10-01 2011-10-01 false Wireless video assist devices. 74.870 Section... Stations § 74.870 Wireless video assist devices. Television broadcast auxiliary licensees and motion picture and television producers, as defined in § 74.801 may operate wireless video assist devices on a...

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 4 2014-10-01 2014-10-01 false Wireless video assist devices. 74.870 Section... Stations § 74.870 Wireless video assist devices. Television broadcast auxiliary licensees and motion picture and television producers, as defined in § 74.801 may operate wireless video assist devices on a...

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 4 2013-10-01 2013-10-01 false Wireless video assist devices. 74.870 Section... Stations § 74.870 Wireless video assist devices. Television broadcast auxiliary licensees and motion picture and television producers, as defined in § 74.801 may operate wireless video assist devices on a...

Transcatheter closure of Patent Ductus Arteriosus through only venous route.

PubMed

Sheikh, Abdul Malik; Duke, Abdul Karim; Sattar, Hina

2018-03-01

Patent ductus arteriosus is a common congenital cardiac defect comprising 5-10% of all these defects in term neonates. Although open chest and video-assisted interruption are still in use, transcatheter occlusion has rapidly become the first choice for patent ductus arteriosus closure in the appropriate patient. Percutaneous closure of patent ductus arteriosus is widely done by transvenous approach guided by aortic access. We present the case of a 2 year old girl who underwent patent ductus arteriosus device occlusion with transvenous access only.

Alveolar ridge expansion-assisted orthodontic space closure in the mandibular posterior region

PubMed Central

Akdeniz, Berat Serdar; Sumer, Mahmut

2013-01-01

Orthodontic closure of old, edentulous spaces in the mandibular posterior region is a major challenge. In this report, we describe a method of orthodontic closure of edentulous spaces in the mandibular posterior region accelerated by piezoelectric decortication and alveolar ridge expansion. Combined piezosurgical and orthodontic treatments were used to close 14- and 15-mm-wide spaces in the mandibular left and right posterior areas, respectively, of a female patient, aged 18 years and 9 months, diagnosed with skeletal Class III malocclusion, hypodontia, and polydiastemas. After the piezoelectric decortication, segmental and full-arch mechanics were applied in the orthodontic phase. Despite some extent of root resorption and anchorage loss, the edentulous spaces were closed, and adequate function and esthetics were regained without further restorative treatment. Alveolar ridge expansion-assisted orthodontic space closure seems to be an effective and relatively less-invasive treatment alternative for edentulous spaces in the mandibular posterior region. PMID:24396740

Vacuum-deposited, nonpolymeric flexible organic light-emitting devices.

PubMed

Gu, G; Burrows, P E; Venkatesh, S; Forrest, S R; Thompson, M E

1997-02-01

We demonstrate mechanically flexible, organic light-emitting devices (OLED's) based on the nonpolymetric thin-film materials tris-(8-hydroxyquinoline) aluminum (Alq(3)) and N, N(?) -diphenyl- N, N(?) -bis(3-methylphenyl)1- 1(?) biphenyl-4, 4(?) diamine (TPD). The single heterostructure is vacuum deposited upon a transparent, lightweight, thin plastic substrate precoated with a transparent, conducting indium tin oxide thin film. The flexible OLED performance is comparable with that of conventional OLED's deposited upon glass substrates and does not deteriorate after repeated bending. The large-area (~1 - cm>(2)) devices can be bent without failure even after a permanent fold occurs if they are on the convex substrate surface or over a bend radius of ~0.5>cm if they are on the concave surface. Such devices are useful for ultralightweight, flexible, and comfortable full-color flat panel displays.

Development of Subischial Prosthetic Sockets with Vacuum-Assisted Suspension for Highly Active Persons with Transfemoral Amputations

DTIC Science & Technology

2012-10-01

materials to facilitate dissemination of this technique. 15. SUBJECT TERMS Transfemoral amputation, sub-ischial socket, prosthesis , vacuum-assisted...an appropriate mechanical pump to create suitable vacuum for suspension of the prosthesis ...sockets of highly active prosthesis users

Prediction of left ventricular dysfunction after device closure of patent ductus arteriosus: proposal for a new functional classification.

PubMed

Kiran, Viralam S; Tiwari, Ashish

2018-04-06

The aims of this study were to determine the incidence and correlates of left ventricular (LV) dysfunction amongst percutaneous patent ductus arteriosus (PDA) device closure patients, and to propose an indexed parameter for predicting LV dysfunction. In a retrospective cross-sectional analysis of 30 months duration, 447 patients who underwent PDA device closure were studied. The diameter of the PDA at the pulmonary artery end was measured in the angiograms in all patients and was indexed for their body surface area. The indexed PDA size was categorised into group A (1-2.9 mm/m², 35/447), B (3-5.9 mm/m², 254/447), C (6-8.9 mm/m², 66/447) and D (>9 mm/m², 35/447). Systolic LV function was evaluated using echocardiography at frequent intervals. Overall, 62.63% of the patients were female (280/447). At baseline, all 447 patients had normal LV function. LV dysfunction was seen in 102/447 (22.8%) patients with 2.8% in category A (1/35), 10.6% in category B (27/254), 34.1% in category C (42/123) and 91.4% in category D (32/35) after PDA device closure. Correlation of indexed PDA size and LV dysfunction was statistically significant (p<0.05). Accurate prediction of LV dysfunction is important in risk stratification, ICU management and counselling in PDA device closures. Indexed PDA size correlates well with post-procedural LV dysfunction. The authors propose a new classification of PDA utilising this accurate, reproducible and easy to perform parameter, which does not involve any extra cost, for risk stratification and early management in device closure of PDA.

Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia.

PubMed

Venkataraman, Ganesh; Strickberger, S Adam; Doshi, Shephal; Ellis, Christopher R; Lakkireddy, Dhanunjaya; Whalen, S Patrick; Cuoco, Frank

2018-01-01

Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31 mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width < 17 mm has not been evaluated. The goal of this study was to determine the acute and short-term safety and efficacy of LAA closure with the WATCHMAN device in patients with a maximal LAA ostial width < 17 mm. Thirty-two consecutive patients with a maximal LAA ostial width < 17 mm as determined by a screening transesophageal echocardiogram (TEE) underwent LAA closure with the WATCHMAN device between March 2015 and November 2016 at five medical centers, and were included in this study. Mean age, body mass index (BMI), and CHA 2 DS 2 -VASC score were 70.8 ± 8.6 years, 29.3 ± 6.5 kg/m 2 , and 3.9 ±1.2, respectively. At the screening TEE, mean maximal LAA ostial width and depth were 15.6 ± 0.6 mm (range 14-16) and 23.2 ± 4.5 mm (range 13-31), respectively. Successful LAA closure with the WATCHMAN device was achieved in 31 of 32 patients (97%), with no major complications. TEE performed 45 days after LAA closure demonstrated no peridevice leak > 5 mm and no device related thrombi. Warfarin was discontinued in all 31 patients 45 days after LAA closure. LAA closure with the WATCHMAN device can be successfully and safely achieved in patients with a maximal LAA ostial width < 17 mm. © 2017 Wiley Periodicals, Inc.

Development of Subischial Prosthetic Sockets with Vacuum-Assisted Suspension for Highly Active Persons with Transfemoral Amputations

DTIC Science & Technology

2014-10-01

Award Number: W81XWH-10-1-0744 TITLE: Development of Subischial Prosthetic Sockets with Vacuum...REPORT TYPE Annual 3. DATES COVERED 15 Sep 2013 – 14 Sep 2014 4. TITLE AND SUBTITLE Development of Subischial Prosthetic Sockets with Vacuum...to develop a highly flexible sub-ischial prosthetic socket with assisted-vacuum suspension for highly active persons with transfemoral amputation. The

Protection of polyphenols in blueberry juice by vacuum-assisted block freeze concentration.

PubMed

Orellana-Palma, Patricio; Petzold, Guillermo; Pierre, Lissage; Pensaben, José Manuel

2017-11-01

Block freeze concentration allows produces high-quality cryoconcentrates with important protection of valuable components from fresh fruit juices. The aim of this study was to investigate the use of vacuum-assisted block freeze concentration under different experimental conditions to protect polyphenols in the elaboration of concentrated blueberry juice. Fresh blueberry juice was radial or unidirectional frozen at -20 and -80 °C for 12 h and vacuum process was performed at 80 kPa during 120 min. Results showed a significant solute increased in the concentrated fraction in all treatments, and the best treatment was - 20 °C/unidirectional with a value of ≈63 °Brix, equivalent to an increase of 3.8 times in the total polyphenol content (76% of retention). The color of concentrated samples was darker than the initial sample, with ΔE* values of >25 CIELab units in all treatments. The vacuum-assisted block freeze concentrations was an effective technology for protecting polyphenols and obtain a concentrated with a higher concentration of solids from blueberry juice, as well as interesting values of process parameters. Copyright © 2017 Elsevier Ltd. All rights reserved.

Left ventricular remodeling and change of systolic function after closure of patent ductus arteriosus in adults: device and surgical closure.

PubMed

Jeong, Young-Hoon; Yun, Tae-Jin; Song, Jong-Min; Park, Jung-Jun; Seo, Dong-Man; Koh, Jae-Kon; Lee, Se-Whan; Kim, Mi-Jeong; Kang, Duk-Hyun; Song, Jae-Kwan

2007-09-01

Left ventricular (LV) remodeling and predictors of LV systolic function late after closure of patent ductus arteriosus (PDA) in adults remain to be clearly demonstrated. In 45 patients with PDA, including 28 patients who received successful occlusion using the Amplatzer device (AD group) (AGA, Golden Valley, MN) and 17 patients who received surgical closure (OP group), echocardiography studies were performed before closure and 1 day (AD group) or within 7 days (OP group) after closure, and then were repeated at > or = 6 months (17 +/- 13 months). In both groups, LV ejection fraction (EF) and end-diastolic volume index were significantly decreased immediately after closure, whereas end-systolic volume index did not change. During the long-term follow-up period, end-systolic as well as end-diastolic volume indices decreased significantly in both groups and LV EF recovered compared to the immediate postclosure state. However, LV EF remained low compared to the preclosure state. Five patients (11.1%) including 3 patients in the AD group and 2 patients in the OP group showed persistent late LV systolic dysfunction (EF <50%). In stepwise, multiple logistic regression analysis, preclosure EF was the only independent predictor of late normal postclosure EF (odds ratio, 1.230; 95% CI, 1.054-1.434; P = .008). Receiver operating characteristic curve analysis showed that preclosure EF > or = 62% had a sensitivity of 72% and a specificity of 83% for predicting late normal LV EF after closure. Left ventricular EF remains low late after PDA closure compared with preclosure state in adults. Preclosure LV EF is the best index to predict late postclosure LV EF.

Ventricular assist devices and sleep-disordered breathing.

PubMed

Akkanti, Bindu; Castriotta, Richard J; Sayana, Pavani; Nunez, Emmanuel; Rajapreyar, Indranee; Kumar, Sachin; Nathan, Sriram; Majid, Ruckshanda

2017-10-01

Congestive heart failure is one of the leading causes of morbidity and mortality in the United States, and left ventricular assist devices have revolutionized treatment of end-stage heart failure. Given that sleep apnea results in significant morbidity in these patients with advanced heart failure, practicing sleep physicians need to have an understanding of left ventricular assist devices. In this review, we summarize what is known about ventricular assist devices as they relate to sleep medicine. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Assessment of vacuum-assisted vaginal delivery in a frank breech presentation].

PubMed

Bleu, G; Deruelle, P; Demetz, J; Michel, S; Dufour, P; Depret, S; Subtil, D

2015-02-01

After verification of the eligibility criteria and with an obstetrician familiar with the specific maneuvers likely to be needed, vaginal delivery of breech presentations is possible. If problems arise during the active pushing phase of labor, vacuum extraction has been described in the literature for this uncommon condition with limited series. The aim of this study is to assess retrospectively vacuum extraction in frank breech presentation in our center. This retrospective study of trials of vaginal delivery of fetuses in breech presentation at term compares cases according to whether they did or did not use a vacuum extraction. During a two-year period, 83 patients, whom had trials of vaginal delivery in breech presentations, reached the active pushing/bearing down stage after complete cervical dilatation. Vacuum assistance was applied in six of these (7.2 %). The failure rate for vaginal delivery was significantly higher in the group with compared to without vacuum extraction (33.3 % versus 6.5 %, P<0.05). Moreover, the mean pH at birth was significantly lower in the group with vacuum extraction (7.12±0.11 versus 7.20±0.08, P<0.05), and these infants more frequently had deep cutaneous injuries (66.7 % versus 26.0 %, P<0.05). In fetuses in breech presentation, when vaginal delivery failed, it seems to be safer for the fetuses to perform caesarean section rather than attempt vacuum extraction. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Use of percutaneous closure devices in the removal of central venous catheters from inadvertent arterial catheterizations.

PubMed

Guimaraes, M; Uflacker, R; Schonholz, C; Hannegan, C; Selby, B

2008-06-01

Although rare, misplacement of central venous catheters in supra-aortic arteries is potentially fatal. Five patients had safe catheters removal using percutaneous closure devices. Three patients were coagulopathic, 3 under intensive care and 1 in immediate postoperative limb amputation. Patients were treated successfully, with immediate hemostasis and without complications in a mean follow-up of 12.5 months. Although the number of patients is small, the closure devices proved to be safe. This is a minimally invasive alternative technique in the management of large bore catheters removed from non-compressible puncture sites such as subclavian and brachiocephalic arteries.

[Outcome of transcatheter closure of perimembranous ventricular septal defect with modified double-disk occluder device].

PubMed

Liu, Jing; You, Xiao-hua; Zhao, Xian-xian; Hu, Jian-qiang; Cao, Jiang; Xu, Rong-liang; Wu, Hong; Chen, Shao-ping; Zhang, Jian-liang; Zheng, Xing; Qin, Yong-wen

2010-04-01

To evaluate the efficacy and adverse effects of transcatheter closure of perimembranous ventricular septal defect (pmVSD) with modified double-disk occluder device (MDVO). Clinical data including clinical examination, electrocardiography daily after the procedure for a week, chest-X-rays and TTE before discharge and at 3-5 days after the procedure were analyzed from 604 patients underwent percutaneous closure of a pmVSD with MDVO at our department between December 2001 and December 2008. Procedure was successful in 576 out of 604 patients (95.4%) and 583 VSD occluders were placed. Endocarditis, thromboembolism, or deaths were not observed after procedure. Conduction block occurred in 81 patients (56 RBBB, 14 LBBB) and transient nonparoxysmal ventricular tachycardia in 31 patients after the procedure. Complete heart block occurred in 11 patients, 9 of them recovered in 3 weeks, permanent pacemaker was implanted in 2 patients (one had transient III degrees AVB before the procedure, the other underwent simultaneous closure of ventricular septal defect and atrial septal defect). Trivial/small residual shunts were found in 69 patients (12.0%). The residual shunts disappeared in 31 patients and remained unchanged in 38 patients (6.6%) 7 days after procedures. Aortic regurgitation developed in 5 patients (2 trivial/small, 3 small/moderate), and tricuspid regurgitation was present in 35 patients (32 trivial/small, 3 moderate). Five patients developed haemolysis (device retrieved via catheter in 1 patient due to persistent haemolysis, the other 4 patients recovered 3-14 days post procedure). Pseudoaneurysm of femoral artery occurred in 1 patient, and disappeared by pressure dressing. Device was successfully replaced in 2 patients with either device embolization (n = 1) or device misplacement (n = 1) after device retrieval by catheter. It is safe and effective to close congenital perimembranous ventricular septal defect with domestic-made occluder device.

Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial.

PubMed

Xhepa, Erion; Byrne, Robert A; Schulz, Stefanie; Helde, Sandra; Gewalt, Senta; Cassese, Salvatore; Linhardt, Maryam; Ibrahim, Tareq; Mehilli, Julinda; Hoppe, Katharina; Grupp, Katharina; Kufner, Sebastian; Böttiger, Corinna; Hoppmann, Petra; Burgdorf, Christof; Fusaro, Massimiliano; Ott, Ilka; Schneider, Simon; Hengstenberg, Christian; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan

2014-06-01

Vascular closure devices (VCD) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography. However, clinical studies comparing VCD and manual compression have yielded mixed results, and large randomised clinical trials comparing the two strategies are missing. Moreover, comparative efficacy studies between different VCD in routine clinical use are lacking. The Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial is a prospective, randomised clinical trial designed to compare the outcomes associated with the use of VCD or manual compression to achieve femoral haemostasis. The test hypothesis is that femoral haemostasis after coronary angiography achieved using VCD is not inferior to manual compression in terms of access-site-related vascular complications. Patients undergoing coronary angiography via the common femoral artery will be randomised in a 1:1:1 fashion to receive FemoSeal VCD, EXOSEAL VCD or manual compression. The primary endpoint is the incidence of the composite of arterial access-related complications (haematoma ≥5 cm, pseudoaneurysm, arteriovenous fistula, access-site-related bleeding, acute ipsilateral leg ischaemia, the need for vascular surgical/interventional treatment or documented local infection) at 30 days after randomisation. According to power calculations based on non-inferiority hypothesis testing, enrolment of 4,500 patients is planned. The trial is registered at www.clinicaltrials.gov (study identifier: NCT01389375). The safety of VCD as compared to manual compression in patients undergoing transfemoral coronary angiography remains an issue of clinical equipoise. The aim of the ISAR-CLOSURE trial is to assess whether femoral haemostasis achieved through the use of VCD is non-inferior to manual compression in terms of access-site-related vascular complications.

New devices and techniques for endoscopic closure of gastrointestinal perforations

PubMed Central

Li, Yue; Wu, Jian-Hua; Meng, Yan; Zhang, Qiang; Gong, Wei; Liu, Si-De

2016-01-01

Gastrointestinal perforations, which need to be managed quickly, are associated with high morbidity and mortality. Treatments used to close these perforations range from surgery to endoscopic therapy. Nowadays, with the development of new devices and techniques, endoscopic therapy is becoming more popular. However, there are different indications and clinical efficacies between different methods, because of the diverse properties of endoscopic devices and techniques. Successful management also depends on other factors, such as the precise location of the perforation, its size and the length of time between the occurrence and diagnosis. In this study, we performed a comprehensive review of various devices and introduced the different techniques that are considered effective to treat gastrointestinal perforations. In addition, we focused on the different methods used to achieve successful closure, based on the literature and our clinical experiences. PMID:27672268

Vacuum-assisted fluid flow in microchannels to pattern substrates and cells.

PubMed

Shrirao, Anil B; Kung, Frank H; Yip, Derek; Cho, Cheul H; Townes-Anderson, Ellen

2014-09-01

Substrate and cell patterning are widely used techniques in cell biology to study cell-to-cell and cell-substrate interactions. Conventional patterning techniques work well only with simple shapes, small areas and selected bio-materials. This paper describes a method to distribute cell suspensions as well as substrate solutions into complex, long, closed (dead-end) polydimethylsiloxane (PDMS) microchannels using negative pressure. Our method builds upon a previous vacuum-assisted method used for micromolding (Jeon et al 1999 Adv. Mater 11 946) and successfully patterned collagen-I, fibronectin and Sal-1 substrates on glass and polystyrene surfaces, filling microchannels with lengths up to 120 mm and covering areas up to 13 × 10 mm(2). Vacuum-patterned substrates were subsequently used to culture mammalian PC12 and fibroblast cells and amphibian neurons. Cells were also patterned directly by injecting cell suspensions into microchannels using vacuum. Fibroblast and neuronal cells patterned using vacuum showed normal growth and minimal cell death indicating no adverse effects of vacuum on cells. Our method fills reversibly sealed PDMS microchannels. This enables the user to remove the PDMS microchannel cast and access the patterned biomaterial or cells for further experimental purposes. Overall, this is a straightforward technique that has broad applicability for cell biology.

Vacuum-assisted Fluid Flow in Microchannels to Pattern Substrates and Cells

PubMed Central

Shrirao, Anil B.; Kung, Frank H.; Yip, Derek; Cho, Cheul H.; Townes-Anderson, Ellen

2014-01-01

Substrate and cell patterning are widely used techniques in cell biology to study cell-to-cell and cell-to-substrate interactions. Conventional patterning techniques work well only with simple shapes, small areas and selected bio-materials. This paper describes a method to distribute cell suspensions as well as substrate solutions into complex, long, closed (dead-end) polydimethylsiloxane (PDMS) microchannels using negative pressure. Our method builds upon a previous vacuum-assisted method used for micromolding (Jeon, Choi et al. 1999) and successfully patterned collagen-I, fibronectin and Sal-1 substrates on glass and polystyrene surfaces, filling microchannels with lengths up to 120 mm and covering areas up to 13 × 10 mm2. Vacuum-patterned substrates were subsequently used to culture mammalian PC12 and fibroblast cells and amphibian neurons. Cells were also patterned directly by injecting cell suspensions into microchannels using vacuum. Fibroblast and neuronal cells patterned using vacuum showed normal growth and minimal cell death indicating no adverse effects of vacuum on cells. Our method fills reversibly sealed PDMS microchannels. This enables the user to remove the PDMS microchannel cast and access the patterned biomaterial or cells for further experimental purposes. Overall, this is a straightforward technique that has broad applicability for cell biology. PMID:24989641

A vacuum flash-assisted solution process for high-efficiency large-area perovskite solar cells

NASA Astrophysics Data System (ADS)

Li, Xiong; Bi, Dongqin; Yi, Chenyi; Décoppet, Jean-David; Luo, Jingshan; Zakeeruddin, Shaik Mohammed; Hagfeldt, Anders; Grätzel, Michael

2016-07-01

Metal halide perovskite solar cells (PSCs) currently attract enormous research interest because of their high solar-to-electric power conversion efficiency (PCE) and low fabrication costs, but their practical development is hampered by difficulties in achieving high performance with large-size devices. We devised a simple vacuum flash-assisted solution processing method to obtain shiny, smooth, crystalline perovskite films of high electronic quality over large areas. This enabled us to fabricate solar cells with an aperture area exceeding 1 square centimeter, a maximum efficiency of 20.5%, and a certified PCE of 19.6%. By contrast, the best certified PCE to date is 15.6% for PSCs of similar size. We demonstrate that the reproducibility of the method is excellent and that the cells show virtually no hysteresis. Our approach enables the realization of highly efficient large-area PSCs for practical deployment.

Percutaneous Ventricular Assist Devices: New Deus Ex Machina?

PubMed Central

Arroyo, Diego; Cook, Stéphane

2011-01-01

The development of ventricular assist devices has broadened the means with which one can treat acute heart failure. Percutaneous ventricular assist devices (pVAD) have risen from recent technological advances. They are smaller, easier, and faster to implant, all important qualities in the setting of acute heart failure. The present paper briefly describes the functioning and assets of the most common devices used today. It gives an overview of the current evidence and indications for left ventricular assist device use in cardiogenic shock and high-risk percutaneous coronary intervention. Finally, extracorporeal life support devices are dealt with in the setting of hemodynamic support. PMID:22091361

Electron beam gun with kinematic coupling for high power RF vacuum devices

DOE Office of Scientific and Technical Information (OSTI.GOV)

Borchard, Philipp

An electron beam gun for a high power RF vacuum device has components joined by a fixed kinematic coupling to provide both precise alignment and high voltage electrical insulation of the components. The kinematic coupling has high strength ceramic elements directly bonded to one or more non-ductile rigid metal components using a high temperature active metal brazing alloy. The ceramic elements have a convex surface that mates with concave grooves in another one of the components. The kinematic coupling, for example, may join a cathode assembly and/or a beam shaping focus electrode to a gun stem, which is preferably composedmore » of ceramic. The electron beam gun may be part of a high power RF vacuum device such as, for example, a gyrotron, klystron, or magnetron.« less

[Right patent ductus arteriosus with an ipsilateral aortic arch: percutaneous closure with amplatzer devices].

PubMed

Santiago, Justo; Acuña, Manuel; Arispe, Elizabeth; Camargo, Ronaldo; Neves, Juliana; Arnoni, Daniel; Fontes, Valmir F; Pedra, Carlos A

2007-03-01

The association of a right aortic arch with an ipsilateral patent ductus arteriosus is rare, especially when there are no other intracardiac anomalies. We report three female patients aged 26, 35 and 9 years with this combination in whom previous attempts at surgical closure by thoracotomy and sternotomy were unsuccessful and who subsequently underwent successful percutaneous closure of the defects using Amplatzer devices. In two patients, although angiography demonstrated the presence of type-A patent ductus arteriosus, it was not possible to determine the minimum diameter accurately and it was necessary to measure it using a sizing balloon. An Amplatzer duct occluder was used in two patients and an Amplatzer muscular ventricular septal defect occluder, in the other. In all patients, full closure was confirmed in the catheterization laboratory and the patients were discharged on the same day with no complications. Percutaneous closure of a right patent ductus arteriosus associated with a right aortic arch is feasible, safe and effective.

Development of Sub-Ischial Prosthetic Sockets with Vacuum-Assisted Suspension for Highly Active Persons with Transfemoral Amputations

DTIC Science & Technology

2013-10-01

15. SUBJECT TERMS Transfemoral amputation, sub-ischial socket, prosthesis , vacuum-assisted suspension 16. SECURITY CLASSIFICATION OF: 17...vacuum for suspension of the prosthesis ...14 Task 6 Determine range of volumes to be evacuated from transfemoral sockets of highly active prosthesis users

Shot noise: from Schottky's vacuum tube to present-day quantum devices

NASA Astrophysics Data System (ADS)

Schonenberger, Christian; Oberholzer, Stefan

2004-05-01

Shot-noise in the electrical current through a 'device' is caused by random processes that determine the electron transport from source to drain. Two sources can be distinguished: on the hand, electrons may randomly emanate from the contacts (source and drain), because the relevant states in the reservoirs fluctuate. On the other hand, the transmission through the device is non-deterministic (non-classical). As we demonstrate in this article the former dominates noise in the vacuum tube, whereas the latter applies to coherent mesoscopic devices, which have been studied in great detail during the last decade.

Endonasal Suturing of Nasoseptal Flap to Nasopharyngeal Fascia Using the V-Loc™ Wound Closure Device: 2-Dimensional Operative Video.

PubMed

Zwagerman, Nathan T; Geltzeiler, Mathew N; Wang, Eric W; Fernandez-Miranda, Juan C; Snyderman, Carl H; Gardner, Paul A

2018-05-30

We present a case of cerebrospinal fluid (CSF) leak after endoscopic endonasal resection of a large clival chordoma in an obese patient. The leak was at the lower reconstruction at the craniocervical junction and had failed repositioning. Using the V-Loc™ wound closure device (Covidien, New Haven, Connecticut) to suture the nasoseptal flap to the nasopharyngeal fascia, a water-tight seal was created and, along with a lumbar drain, the patient healed successfully.CSF leak after an endoscopic endonasal approach (EEA) to intradural pathologies remains one of the more common complications.1-4 Various closure techniques have been developed5-8 with success in mitigating this risk, but all have their limitations and rely on multiple layers including vascularized flaps like the nasoseptal flap.9-11 Endonasal suturing of graft materials offers the advantage of creating a water-tight seal. We present the use of the V-Loc™ wound closure device (Covidien) to successfully seal a postoperative CSF leak. The absorbable V-Loc™ wound closure device does not require the surgeon to tie knots, which is the most challenging step in a deep, 2-dimensional corridor. The suture is barbed and is anchored by threading the needle through a prefabricated loop at the end of the suture which locks in place. Each throw of the suture through tissue maintains the suture line as the barbs catch the tissue and prevent retraction. After successful closure, the needle can simply be cut off.The V-Loc™ wound closure device (Covidien) is a safe and effective adjunct to reconstruction after endoscopic endonasal skull base surgery as it provides an option for graft/flap suturing.A written release from the patient whose name or likeness is submitted as part of this Work is on file.

Assistive Devices for Students with Disabilities.

ERIC Educational Resources Information Center

Wisniewski, Lech; Sedlak, Robert

1992-01-01

Describes a variety of devices that can assist students with disabilities. Highlights recently developed devices for students with specific learning disabilities, and with vision, hearing, health, physical, and speech and language impairments. The devices can help rehabilitate, reeducate, facilitate normalcy, or augment current functioning. (GLR)

Introduction of assistive devices: home nurses' practices and beliefs.

PubMed

Roelands, Marc; Van Oost, Paulette; Depoorter, Anne Marie; Buysse, Ann; Stevens, Veerle

2006-04-01

This paper reports a study describing home nurses' intention and current practices regarding introducing assistive devices, and investigating whether their practice is related to social cognitive factors (attitudes, subjective norms and self-efficacy). Home nurses not only care for patients in particular medical domains, but also educate and guide them towards more independence. Patients with age-related disabilities in mobility and self-care might benefit from the use of assistive devices. A home nurse might be the first and only person to discuss the disability and use of an assistive device. Therefore, home nurses' beliefs about the introduction of assistive devices could affect their daily practices. A cross-sectional study was conducted with a convenience sample of 64 home nurses chosen from a random sample of home nursing departments. The home nurses completed a self-administered questionnaire. The Theory of Planned Behaviour framework was used to develop the social cognitive measures regarding each of the six steps distinguished in the introduction of assistive devices. Home nurses had positive attitudes and high levels of intention, subjective norm and self-efficacy towards most steps of the decision process to introduce assistive devices. In a multiple linear regression analysis, attitude and self-efficacy predicted intention to introduce assistive devices to older clients with disabilities. Intention was correlated to home nurses' current practices. The findings suggest that conditions are present to involve home nurses more explicitly in the introduction of assistive devices to their patients. Social cognitive factors should be taken into account when developing interventions that aim to support home nurses to do this.

The TopClosure® 3S System, for skin stretching and a secure wound closure.

PubMed

Topaz, Moris; Carmel, Narin-Nard; Silberman, Adi; Li, Ming Sen; Li, Yong Zhong

2012-07-01

The principle of stretching wound margins for primary wound closure is commonly practiced and used for various skin defects, leading at times to excessive tension and complications during wound closure. Different surgical techniques, skin stretching devices and tissue expanders have been utilized to address this issue. Previously designed skin stretching devices resulted in considerable morbidity. They were invasive by nature and associated with relatively high localized tissue pressure, frequently leading to necrosis, damage and tearing of skin at the wound margins. To assess the clinical effectiveness and performance and, to determine the safety of TopClosure® for gradual, controlled, temporary, noninvasive and invasive applications for skin stretching and secure wound closing, the TopClosure® device was applied to 20 patients for preoperative skin lesion removal and to secure closure of a variety of wound sizes. TopClosure® was reinforced with adhesives, staples and/or surgical sutures, depending on the circumstances of the wound and the surgeon's judgment. TopClosure® was used prior to, during and/or after surgery to reduce tension across wound edges. No significant complications or adverse events were associated with its use. TopClosure® was effectively used for preoperative skin expansion in preparation for dermal resection (e.g., congenital nevi). It aided closure of large wounds involving significant loss of skin and soft tissue by mobilizing skin and subcutaneous tissue, thus avoiding the need for skin grafts or flaps. Following surgery, it was used to secure closure of wounds under tension, thus improving wound aesthetics. A sample case study will be presented. We designed TopClosure®, an innovative device, to modify the currently practiced concept of wound closure by applying minimal stress to the skin, away from damaged wound edges, with flexible force vectors and versatile methods of attachment to the skin, in a noninvasive or invasive manner.

Percutaneous device closure of atrial septal defect results in very early and sustained changes of right and left heart function.

PubMed

Monfredi, Oliver; Luckie, Matthew; Mirjafari, Hoda; Willard, Terence; Buckley, Helen; Griffiths, Linda; Clarke, Bernard; Mahadevan, Vaikom S

2013-08-20

To investigate the echocardiographic effects of percutaneous closure of secundum atrial septal defect (ASD) in adults and assess which pre-closure parameters predict good response to closure. ASD is a common congenital heart disease often undiscovered until adulthood. ASD closure has been revolutionized by the use of percutaneous devices. The effects of these procedures on echocardiographic parameters are not well characterized. Patients undergoing percutaneous device closure of ASD between June 2007 and June 2009 had 3 sequential echocardiograms reviewed: pre-procedure, immediate post-procedure (24 hours) and 6-8 weeks post-procedure. Significant changes from baseline were investigated using paired t-test/1-way ANOVA. Pearson correlation (2-tailed) tests were used to categorize patients as 'good responders' to closure in terms of selected parameters. 129 echocardiograms in 43 consecutive patients were included. Remodeling of both ventricles occurred immediately following ASD closure and was sustained. Right ventricular (RV) diameter in diastole decreased by 13.5% and 19.3% compared to baseline at 24 hours and 6-8 weeks post-closure, respectively (p<0.05); Left ventricular (LV) diameter in diastole increased by 8.5% and 15.6%, respectively (p<0.05). Functional parameters of the RV also demonstrated early and sustained decreases (TAPSE decreased by 8.3% and 17% compared to baseline at 24 hours and 6-8 weeks post-closure, respectively (p<0.05)). Smaller RV baseline diameter appeared to predict good response to closure. Percutaneous ASD closure has immediate, sustained benefits on multiple echocardiographic parameters. Good responders have smaller RV at baseline, suggesting early closure is preferable. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Multiscale Thermo-Mechanical Design and Analysis of High Frequency and High Power Vacuum Electron Devices

NASA Astrophysics Data System (ADS)

Gamzina, Diana

Diana Gamzina March 2016 Mechanical and Aerospace Engineering Multiscale Thermo-Mechanical Design and Analysis of High Frequency and High Power Vacuum Electron Devices Abstract A methodology for performing thermo-mechanical design and analysis of high frequency and high average power vacuum electron devices is presented. This methodology results in a "first-pass" engineering design directly ready for manufacturing. The methodology includes establishment of thermal and mechanical boundary conditions, evaluation of convective film heat transfer coefficients, identification of material options, evaluation of temperature and stress field distributions, assessment of microscale effects on the stress state of the material, and fatigue analysis. The feature size of vacuum electron devices operating in the high frequency regime of 100 GHz to 1 THz is comparable to the microstructure of the materials employed for their fabrication. As a result, the thermo-mechanical performance of a device is affected by the local material microstructure. Such multiscale effects on the stress state are considered in the range of scales from about 10 microns up to a few millimeters. The design and analysis methodology is demonstrated on three separate microwave devices: a 95 GHz 10 kW cw sheet beam klystron, a 263 GHz 50 W long pulse wide-bandwidth sheet beam travelling wave tube, and a 346 GHz 1 W cw backward wave oscillator.

The benefits of using a vacuum-assisted socket system to improve balance and gait in elderly transtibial amputees.

PubMed

Samitier, C Beatriz; Guirao, Lluis; Costea, Maria; Camós, Josep M; Pleguezuelos, Eulogio

2016-02-01

Lower limb amputation leads to impaired balance, ambulation, and transfers. Proper fit of the prosthesis is a determining factor for successful ambulation. Vacuum-assisted socket systems extract air from the socket, which decreases pistoning and probability of soft-tissue injuries and increases proprioception and socket comfort. To investigate the effect of vacuum-assisted socket system on transtibial amputees' performance-based and perceived balance, transfers, and gait. Quasi-experimental before-and-after study. Subjects were initially assessed using their prosthesis with the regular socket and re-evaluated 4 weeks after fitting including the vacuum-assisted socket system. We evaluated the mobility grade using Medicare Functional Classification Level, Berg Balance Scale, Four Square Step Test, Timed Up and Go Test, the 6-Min Walk Test, the Locomotor Capabilities Index, Satisfaction with Prosthesis (SAT-PRO questionnaire), and Houghton Scale. A total of 16 unilateral transtibial dysvascular amputees, mean age 65.12 (standard deviation = 10.15) years. Using the vacuum-assisted socket system, the patients significantly improved in balance, gait, and transfers: scores of the Berg Balance Scale increased from 45.75 (standard deviation = 6.91) to 49.06 (standard deviation = 5.62) (p < 0.01), Four Square Step Test decreased from 18.18 (standard deviation = 3.84) s to 14.97 (3.9) s (p < 0.01), Timed Up and Go Test decreased from 14.3 (standard deviation = 3.29) s to 11.56 (2.46) s (p < 0.01). The distance walked in the 6-Min Walk Test increased from 288.53 (standard deviation = 59.57) m to 321.38 (standard deviation = 72.81) m (p < 0.01). Vacuum-assisted socket systems are useful for improving balance, gait, and transfers in over-50-year-old dysvascular transtibial amputees. This study gives more insight into the use of vacuum-assisted socket systems to improve elderly transtibial dysvascular amputees

Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal{sup ®} Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pieper, Claus Christian, E-mail: claus.christian.pieper@ukb.uni-bonn.de; Thomas, Daniel, E-mail: daniel.thomas@ukb.uni-bonn.de; Nadal, Jennifer, E-mail: jennifer.nadal@ukb.uni-bonn.de

PurposeTo intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal{sup ®} vascular closure device (VCD) and manual compression (MC) in a prospective study design.MethodsPatients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal{sup ®}-VCD in one and MC in the other intervention. Patients were clinically and sonographically examined and were given questionnaires 1 day after intervention [groin- and back-pain during bedrest (100-point visual analog scale; 0: no pain); comfortability of bedrest (10-point Likert scale, 1: comfortable), satisfaction with closure (10-point Likert scale, 1: very satisfied)].more » Results were analyzed in a cross-over design.Results48 patients (29 male, median age 62.5 (32–88) years) were included. An ExoSeal{sup ®}-VCD was used first in 25 cases. As four of these subsequently refused MC as second intervention, data from 44 patients could be analyzed. All closures were technically successful (successful device deployment) without major complications. Groin- and back-pain after VCD-use/MC was 0 (0–15) vs. 10 (0–80) and 0 (0–75) vs. 25 (0–90), respectively (p < 0.0001). Bedrest after VCD-use was more comfortable than after MC [1 (range 1–7) vs. 6 (2–10); p < 0.0001]. Satisfaction with the closure procedure and with the intervention in general was higher after VCD-use compared to MC [1 (1–3) vs. 5 (2–10) and 1 (1–2) vs. 2 (1–4), respectively; p < 0.0001].ConclusionIntra-individual comparison showed pain levels and discomfort to be significantly lower after ExoSeal{sup ®} use compared to MC. VCD closure was associated with higher satisfaction both with the closure itself and with the intervention in general.« less

Remote vacuum or pressure sealing device and method for critical isolated systems

DOEpatents

Brock, James David [Newport News, VA; Keith, Christopher D [Newport News, VA

2012-07-10

A remote vacuum or pressure sealing apparatus and method for making a radiation tolerant, remotely prepared seal that maintains a vacuum or pressure tight seal throughout a wide temperature range. The remote sealing apparatus includes a fixed threaded sealing surface on an isolated system, a gasket, and an insert consisting of a plug with a protruding sample holder. An insert coupling device, provided for inserting samples within the isolated system, includes a threaded fastener for cooperating with the fixed threaded sealing surface on the isolated system. The insert coupling device includes a locating pin for azimuthal orientation, coupling pins, a tooted coaxial socket wrench, and an insert coupling actuator for actuating the coupling pins. The remote aspect of the sealing apparatus maintains the isolation of the system from the user's environment, safely preserving the user and the system from detrimental effect from each respectively.

Retrograde transcatheter device closure of a complex paravalvular leak after bioprosthetic pulmonary valve replacement in a pediatric patient.

PubMed

Chikkabyrappa, Sathish; Mosca, Ralph S; McElhinney, Doff B

2016-06-01

We report a case of retrograde transcatheter device closure of a complex paravalvular leak (PVL) after bioprosthetic pulmonary valve replacement (PVR) in a 13-year-old patient with congenital pulmonary valve stenosis. There are prior reports of pulmonary PVL closure after PVR in adults (Seery and Slack, Congenit Heart Dis 2014;9:E19-F22), but indications for and technical considerations in PVL closure after bioprosthetic PVR, particularly in children, are not well defined. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... wireless video assist devices may not be transferred or assigned. (i) The product literature that... 47 Telecommunication 4 2010-10-01 2010-10-01 false Wireless video assist devices. 74.870 Section... EXPERIMENTAL RADIO, AUXILIARY, SPECIAL BROADCAST AND OTHER PROGRAM DISTRIBUTIONAL SERVICES Low Power Auxiliary...

[Robot-assisted atrial septal defect closure in adults: first experience in Russia].

PubMed

Arkhipov, A N; Bogachev-Prokofiev, A V; Zubritskiy, A V; Khapaev, T S; Gorbatykh, Yu N; Pavlushin, P M; Karaskov, A M

To analyze immediate results of minimally invasive robot-assisted atrial septal defect (ASD) closure in adults. For the period from March 2012 to November 2016 sixty patients with contraindications to endovascular procedure have undergone robot-assisted atrial septal defect closure at Meshalkin Siberian Federal Biomedical Research Center. Mean age was 34.5±11.3 years, body mass index - 24.6±4.0 kg/m 2 . 48 (80%) patients had NYHA class II before surgery. In 37 (61.7%) patients isolated ASD with deficiency or absence of one edge was diagnosed, isolated ASD with primary septum aneurysm - in 16 (26.7%) cases, 7 (11.6%) patients had reticulate ASD. 5 (8.3%) patients had concomitant tricuspid valve insufficiency required surgical repair (suture annuloplasty). All operations were performed under cardiopulmonary bypass with peripheral cannulation. Right-sided anterolateral mini-thoracotomy was used in the first 43 patients. Following 17 patients underwent completely endoscopic procedure. Depending on the shape, size and anatomical features of the defect we performed suturing (14 patients, 23.3%) or repair with xenopericardial patch (46%, 76.6%). Mean CPB and aortic cross-clamping time was 89.1±28.7 and 24.8±9.5 min, respectively. Postoperative variables: mechanical ventilation 3.3±1.5 hours, ICU-stay - 18.2±3.7 hours, postoperative hospital-stay - 13.4±5.7 days. There were no mortality and any life-threatening intra- and postoperative complications. Cases of conversion to thoraco-/sternotomy and postoperative bleeding followed by redo surgery were also absent. 23 patients were followed-up within 1 year, 6 patients - within 2 years, 3 patients - within 3 years. All patients were in NYHA class I-II with 100% freedom from ASD recanalization and redo surgery. According to echocardiography data there were decreased right heart, pulmonary artery pressure and preserved left ventricular function in early postoperative period and 1 year after surgery. In view of favorable

Non-reclosing pressure relief device for vacuum systems

DOEpatents

Swansiger, William A.

1994-01-01

A non-reclosing overpressure protection device such as a rupture disc provides a non-reclosing opening upon forcible contact with a knife blade. A bellows, having an inlet capable of being sealably connected to a source of pressure (the vacuum system) and an outlet containing the rupture disc, transmits the pressure in the system to the disc. The bellows maintains the disc away from the knife when the pressure is below an overpressure amount, and carries the disc to a position when the pressure is above an overpressure amount where the disc is ruptured by the knife.

Non-reclosing pressure relief device for vacuum systems

DOEpatents

Swansiger, W.A.

1994-02-08

A non-reclosing overpressure protection device such as a rupture disc provides a non-reclosing opening upon forcible contact with a knife blade. A bellows, having an inlet capable of being sealably connected to a source of pressure (the vacuum system) and an outlet containing the rupture disc, transmits the pressure in the system to the disc. The bellows maintains the disc away from the knife when the pressure is below an overpressure amount, and carries the disc to a position when the pressure is above an overpressure amount where the disc is ruptured by the knife. 6 figures.

Automated Road Closure Gate

DOT National Transportation Integrated Search

2000-05-01

This report presents the procedures involved in the research, design, construction, and testing of an Automated Road Closure Gate. The current road closure gates used in South Dakota are often unsafe and difficult to operate. This report will assist ...

Cerebrovascular accidents in patients with a ventricular assist device.

PubMed

Tsukui, Hiroyuki; Abla, Adib; Teuteberg, Jeffrey J; McNamara, Dennis M; Mathier, Michael A; Cadaret, Linda M; Kormos, Robert L

2007-07-01

A cerebrovascular accident is a devastating adverse event in a patient with a ventricular assist device. The goal was to clarify the risk factors for cerebrovascular accident. Prospectively collected data, including medical history, ventricular assist device type, white blood cell count, thrombelastogram, and infection, were reviewed retrospectively in 124 patients. Thirty-one patients (25%) had 48 cerebrovascular accidents. The mean ventricular assist device support period was 228 and 89 days in patients with and without cerebrovascular accidents, respectively (P < .0001). Sixty-six percent of cerebrovascular accidents occurred within 4 months after implantation. Actuarial freedom from cerebrovascular accident at 6 months was 75%, 64%, 63%, and 33% with the HeartMate device (Thoratec Corp, Pleasanton, Calif), Thoratec biventricular ventricular assist device (Thoratec Corp), Thoratec left ventricular assist device (Thoratec), and Novacor device (WorldHeart, Oakland, Calif), respectively. Twenty cerebrovascular accidents (42%) occurred in patients with infections. The mean white blood cell count at the cerebrovascular accident was greater than the normal range in patients with infection (12,900/mm3) and without infection (9500/mm3). The mean maximum amplitude of the thrombelastogram in the presence of infection (63.6 mm) was higher than that in the absence of infection (60.7 mm) (P = .0309). The risk of cerebrovascular accident increases with a longer ventricular assist device support period. Infection may activate platelet function and predispose the patient to a cerebrovascular accident. An elevation of the white blood cell count may also exacerbate the risk of cerebrovascular accident even in patients without infection. Selection of device type, prevention of infection, and meticulous control of anticoagulation are key to preventing cerebrovascular accident.

ASD Closure in Structural Heart Disease.

PubMed

Wiktor, Dominik M; Carroll, John D

2018-04-17

While the safety and efficacy of percutaneous ASD closure has been established, new data have recently emerged regarding the negative impact of residual iatrogenic ASD (iASD) following left heart structural interventions. Additionally, new devices with potential advantages have recently been studied. We will review here the potential indications for closure of iASD along with new generation closure devices and potential late complications requiring long-term follow-up. With the expansion of left-heart structural interventions and large-bore transseptal access, there has been growing experience gained with management of residual iASD. Some recently published reports have implicated residual iASD after these procedures as a potential source of diminished clinical outcomes and mortality. Additionally, recent trials investigating new generation closure devices as well as expanding knowledge regarding late complications of percutaneous ASD closure have been published. While percutaneous ASD closure is no longer a novel approach to managing septal defects, there are several contemporary issues related to residual iASD following large-bore transseptal access and new generation devices which serve as an impetus for this review. Ongoing attention to potential late complications and decreasing their incidence with ongoing study is clearly needed.

Occiput posterior fetal head position increases the risk of anal sphincter injury in vacuum-assisted deliveries.

PubMed

Wu, Jennifer M; Williams, Kathryn S; Hundley, Andrew F; Connolly, AnnaMarie; Visco, Anthony G

2005-08-01

The purpose of this study was to determine whether an occiput posterior (OP) fetal head position increases the risk for anal sphincter injury when compared with an occiput anterior (OA) position in vacuum-assisted deliveries. We conducted a retrospective cohort study of 393 vacuum-assisted singleton vaginal deliveries. Maternal demographics and obstetric and neonatal data were collected from an obstetric database and chart review. Within the OP group, 41.7% developed a third- or fourth-degree laceration compared with 22.0% in the OA group (OR 2.5, 95% CI 1.4-4.7). In a logistic regression model that controlled for BMI, race, nulliparity, length of second stage, episiotomy, birth weight, head circumference, and fetal head position, OP position was 4.0 times (95% CI 1.7-9.6) more likely to be associated with an anal sphincter injury than OA position. Among vacuum deliveries, an OP head position confers an incrementally increased risk for anal sphincter injury over an OA position.

Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology).

PubMed

Reddy, Vivek Y; Möbius-Winkler, Sven; Miller, Marc A; Neuzil, Petr; Schuler, Gerhard; Wiebe, Jens; Sick, Peter; Sievert, Horst

2013-06-25

The purpose of this study was to assess the safety and efficacy of left atrial appendage (LAA) closure in nonvalvular atrial fibrillation (AF) patients ineligible for warfarin therapy. The PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that LAA closure with the Watchman device (Boston Scientific, Natick, Massachusetts) was noninferior to warfarin therapy. However, the PROTECT AF trial only included patients who were candidates for warfarin, and even patients randomly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation. A multicenter, prospective, nonrandomized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS₂ (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ≥1, who were considered ineligible for warfarin. The primary efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke, systemic embolism, and cardiovascular/unexplained death. The mean CHADS₂ score and CHA₂DS₂-VASc (CHADS₂ score plus 2 points for age ≥75 years and 1 point for vascular disease, age 65 to 74 years, or female sex) score were 2.8 ± 1.2 and 4.4 ± 1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6 months. Serious procedure- or device-related safety events occurred in 8.7% of patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year): ischemic stroke in 3 patients (1.7% per year) and hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS₂ scores of the patient cohort. LAA closure with the Watchman device can be safely performed without a warfarin

Association of aortic stiffness to brain natriuretic peptide in children before and after device closure of patent ductus arteriosus

PubMed Central

Mahfouz, Ragab A.; Alzaiat, Ahmad; Gad, Marwa

2014-01-01

Objectives We evaluated the influence of device closure for patent ductus arteriosus (PDA) on the aortic stiffness index (ASI) and brain natriuretic peptide (BNP) and their association with cardiac function. Patients and methods ASI and echocardiography assessment before and after treatment (16 ± 9 months) in 48 children with PDA (mean age 10 ± 4.5) and 52 control children (mean age 9.7 ± 4.6). BNP level was measured pre-closure for all children, and was measured six months after closure only for children with PDA. Results ASI was higher in PDA patients than in controls (P < 0.001). ASI correlated with age (P < 0.05), LVEF% (P < 0.01), E/E′ (<0.03), pulmonary artery pressure (P < 0.001), and BNP (P < 0.001). ASI and BNP significantly decreased after closure (P < 0.001). ASI and BNP were independent predictors for post-closure systolic dysfunction (P < 0.001and <0.005, respectively). Receiver operating curve (ROC) analysis showed that ASI ⩾ 13.5, BNP level ⩾75 pg/ml and basal mean pulmonary artery pressure (PAP) ⩾ 23 were powerful predictors for post-closure systolic function. Conclusion ASI is significantly associated with BNP and basal PAP in children with PDA. After device closure, aortic distensibility improved significantly and was associated with significant improvement in both systolic and diastolic functions. ASI can be used for monitoring the course of patients with PDA, and may give opportunities for early intervention. PMID:25544819

Flat epithelial atypia in directional vacuum-assisted biopsy of breast microcalcifications: surgical excision may not be necessary.

PubMed

McCroskey, Zulfia; Sneige, Nour; Herman, Carolyn R; Miller, Ross A; Venta, Luz A; Ro, Jae Y; Schwartz, Mary R; Ayala, Alberto G

2018-02-21

The aim of this study was to analyze the clinicopathological features of patients with flat epithelial atypia, diagnosed in directional vacuum-assisted biopsy targeting microcalcifications, to identify upgrade rate to in situ ductal or invasive breast carcinoma, and determine factors predicting carcinoma in the subsequent excision. We retrospectively evaluated the histological, clinical, and mammographic features of 69 cases from 65 women, with directional vacuum-assisted biopsy-diagnosed flat epithelial atypia with or without atypical ductal hyperplasia or atypical lobular hyperplasia, which underwent subsequent surgical excision. The extent and percentage of microcalcifications sampled by directional vacuum-assisted biopsy were evaluated by mammography. All biopsy and surgical excision slides were reviewed. The age of the women ranged from 40 to 85 years (mean 57 years). All patients presented with mammographically detected microcalcifications only, except in one case that had associated architectural distortion. Extent of calcifications ranged from <1 cm (n = 47), 1-3 cm (n = 15) to > 3 cm (n = 6), and no measurement (n = 1). A mean of 11 cores (range 6-25) was obtained from each lesion. Post-biopsy mammogram revealed >90% removal of calcifications in 81% of cases. Pure flat epithelial atypia represented nearly two-thirds of directional vacuum-assisted biopsy specimens (n = 43, 62%), while flat epithelial atypia coexisted with atypical ductal hyperplasia (18 cases, 26%), or atypical lobular hyperplasia (8 cases, 12%). Upon excision, none of the cases were upgraded to in situ ductal or invasive breast cancer. In one case, however, an incidental, tubular carcinoma (4 mm) was found away from biopsy site. Excluding this case, the upgrade rate was 0%. Our study adds to the growing evidence that diagnosis of flat epithelial atypia on directional vacuum-assisted biopsy for microcalcifications as the only imaging finding is not associated

Clinically apparent long-term electric disturbances in the acute and very long-term of patent foramen ovale device-based closure.

PubMed

Rigatelli, Gianluca; Zuin, Marco; Pedon, Luigi; Zecchel, Roberto; Dell'Avvocata, Fabio; Carrozza, Antonio; Zennaro, Marco; Pastore, Gianni; Zanon, Francesco

2017-03-01

Incidence of electrical disturbances in patients submitted to transcatheter patent foramen ovale (PFO) closure has not been fully clarified in a large population. The aim of the study is to assess the incidence of atrial fibrillation, supraventricular tachi-arrhythmias, and atrio-ventricular block in the acute and very long-term follow-up. We reviewed the medical and instrumental data of 1000 consecutive patients (mean age 47.3±17.1years) prospectively enrolled in two centers over a 13-year period (February 1999 to February 2012) for right-to-left (R-to-L) shunt ICE-aided catheter-based closure using different devices. Successful transcatheter PFO closure was achieved in 99.8% of the patients. Implanted devices were: Amplatzer PFO Occluder in 463 patients (46.3%), Amplatzer ASD Cribriform Occluder in 420 patients (42.0%), Premere Occlusion System in 95 patients (9.5%), and Biostar Occluder in 22 patients (2.2%). Postprocedural electrical complications occurred in 5.9% of patients. The only independent predictors of electrophysiological complications were female gender (OR 2.3, 0.5-5.1 [95% CI], p<0.001) and device disk >30mm (OR 5.0, 1.2-7.2 [95% CI], p<0.001). On a mean follow-up of 12 .3±0.6years (minimum 4- maximum 17years), electrical complications occurred in 1.4% of patients including one only case of complete AVB and 5 cases of permanent AF. The only independent predictors were female gender (OR 2.3, 0.5-5.1 [95% CI], p<0.001) and device disk >30mm (OR 5.0, 1.2-7.2 [95% CI], p<0.001). Device-based closure of PFO using different devices, appeared very safe from an electrophysiological point of view with low incidence of electrical disturbances even in the very long-term follow-up. Copyright © 2016 Elsevier Inc. All rights reserved.

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

Surgical debridement, vacuum therapy and pectoralis plasty in poststernotomy mediastinitis.

PubMed

Ennker, I C; Pietrowski, D; Vöhringer, L; Kojcici, B; Albert, A; Vogt, P M; Ennker, J

2009-11-01

In cardiac surgery poststernotomy mediastinitis continues to be a serious cause of morbidity and mortality. We report our experience with vacuum-assisted closure (VAC) therapy followed by reconstruction with M. pectoralis muscle flaps as treatment for deep sternal wound infections. Our group performed a retrospective analysis of 3630 consecutive cardiac surgical patients using median sternotomy from 11/2004 to 11/2007. After removing sternal wires, necrotic debris and potentially infective material, restabilisation of the sternum was performed and VAC therapy was employed. Wound closure and subsequent reconstruction were performed using a bilateral pectoralis muscle plasty. Of the analysed patients 16 female and 29 male patients suffered from deep sternal wound infections and were treated with VAC. The most common risk factors were diabetes mellitus odds ratio (OR 3.5), chronic obstructive pulmonary disease (COPD) (OR 2.9), use of bilateral mammarian artery (OR 2.0) and obesity (1.8). The median age of patients with deep sternal infections was similar to control patients. Staphylococcus epidermis was the most common pathogen (37.8%) followed by Enterococcus faecilis (22.2%) and Staphylococcus aureus (17.8). In 22.2% no pathogen could be detected. The 30 day mortality was 0%, the in-hospital mortality was 15.6%. The results of our studies demonstrate that vacuum therapy in conjunction with early and aggressive debridement is an effective strategy for treating poststernotomy mediastinitis. We consider pectoralis major muscle flap reconstruction as a safe technique and regard it as the primary choice for wound closure in poststernotomy mediastinitis. (c) 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

The cost of assistive devices for children with mobility limitation.

PubMed

Korpela, R A; Siirtola, T O; Koivikko, M J

1992-10-01

This study evaluated the costs of assistive devices for children with motor limitations at home, in day care, and in school, and the effect of diagnosis and severity of disabilities on costs. 201 children (mean age 7.4 years) who used 1274 various assistive devices (85.7% at home, 6.1% in day care, and 8.2% in school) were studied. The cost per device varied from $8.14 to $8138 with an average value of $539 per device. The distribution of costs per capita was unequal: 52.2% of children used 15.6% of total costs and 4.5% of children used 20.8% of total costs. The severity of motor impairment and the age of the child were the most important indicators associated with the need and cost of assistive devices. Assistive devices for basic needs, such as sitting, mobility, and personal hygiene, had a relatively low effect on costs in comparison with the high-technology devices, like powered wheelchairs and computers. Better cooperation with day care and school professionals, better assessment of needs, follow-up and recirculation of assistive devices are ways to promote rehabilitation services and partly solve the discrepancies between the costs of available technology and the resources to pay for it.

Vacuum status-display and sector-conditioning programs

NASA Astrophysics Data System (ADS)

Skelly, J.; Yen, S.

1990-08-01

Two programs have been developed for observation and control of the AGS vacuum system, which include the following notable features: (1) they incorporate a graphical user interface and (2) they are driven by a relational database which describes the vacuum system. The vacuum system comprises some 440 devices organized into 28 vacuum sectors. The status-display program invites menu selection of a sector, interrogates the relational database for relevant vacuum devices, acquires live readbacks and posts a graphical display of their status. The sector-conditioning program likewise invites sector selection, produces the same status display and also implements process control logic on the sector devices to pump the sector down from atmospheric pressure to high vacuum over a period extending several hours. As additional devices are installed in the vacuum system, the devices are added to the relational database; these programs then automatically include the new devices.

Surface oxidation of GaN(0001): Nitrogen plasma-assisted cleaning for ultrahigh vacuum applications

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gangopadhyay, Subhashis; Schmidt, Thomas, E-mail: tschmidt@ifp.uni-bremen.de; Kruse, Carsten

The cleaning of metal-organic vapor-phase epitaxial GaN(0001) template layers grown on sapphire has been investigated. Different procedures, performed under ultrahigh vacuum conditions, including degassing and exposure to active nitrogen from a radio frequency nitrogen plasma source have been compared. For this purpose, x-ray photoelectron spectroscopy, reflection high-energy electron diffraction, and scanning tunneling microscopy have been employed in order to assess chemical as well as structural and morphological surface properties. Initial degassing at 600 °C under ultrahigh vacuum conditions only partially eliminates the surface contaminants. In contrast to plasma assisted nitrogen cleaning at temperatures as low as 300 °C, active-nitrogen exposure at temperaturesmore » as high as 700 °C removes the majority of oxide species from the surface. However, extended high-temperature active-nitrogen cleaning leads to severe surface roughening. Optimum results regarding both the removal of surface oxides as well as the surface structural and morphological quality have been achieved for a combination of initial low-temperature plasma-assisted cleaning, followed by a rapid nitrogen plasma-assisted cleaning at high temperature.« less

Advances in bioartificial liver assist devices.

PubMed

Patzer, J F

2001-11-01

Rapid advances in development of bioartificial liver assist devices (BLADs) are exciting clinical interest in the application of BLAD technology for support of patients with acute liver failure. Four devices (Circe Biomedical HepatAssist, Vitagen ELAD, Gerlach BELS, and Excorp Medical BLSS) that rely on hepatocytes cultured in hollow-fiber membrane technology are currently in various stages of clinical evaluation. Several alternative approaches for culture and perfusion of hepatocytes have been evaluated in preclinical, large animal models of liver failure, or at a laboratory scale. Engineering design issues with respect to xenotransplantation, BLAD perfusion, hepatocyte functionality and culture maintenance, and ultimate distribution of a BLAD to a clinical site are delineated.

Long-term clinical evaluation of a 800-nm long-pulsed diode laser with a large spot size and vacuum-assisted suction for hair removal.

PubMed

Ibrahimi, Omar A; Kilmer, Suzanne L

2012-06-01

The long-pulsed diode (800-810-nm) laser is one of the most commonly used and effective lasers for hair removal. Limitations of currently available devices include a small treatment spot size, treatment-associated pain, and the need for skin cooling. To evaluate the long-term hair reduction capabilities of a long-pulsed diode laser with a large spot size and vacuum assisted suction. Thirty-five subjects were enrolled in a prospective, self-controlled, single-center study of axillary hair removal. The study consisted of three treatments using a long-pulsed diode laser with a large spot size and vacuum-assisted suction at 4- to 6-week intervals with follow-up visits 6 and 15 months after the last treatment. Hair clearance was quantified using macro hair-count photographs taken at baseline and at 6- and 15-month follow-up visits. Changes in hair thickness and color, levels of treatment-associated pain, and adverse events were additional study endpoints. There was statistically significant hair clearance at the 6 (54%) and 15-month (42%) follow-up visits. Remaining hairs were thinner and lighter at the 15-month follow-up visit, and the majority of subjects reported feeling up to mild to moderate pain during treatment without the use of pretreatment anesthesia or skin cooling. A long-pulsed diode laser with a large spot size and vacuum-assisted suction is safe and effective for long-term hair removal. This is the largest prospective study to evaluate long-term hair removal and the first to quantify decreases in hair thickness and darkness with treatment. © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

Extended negative pressure wound therapy-assisted dermatotraction for the closure of large open fasciotomy wounds in necrotizing fasciitis patients

PubMed Central

2014-01-01

Background Necrotizing fasciitis (NF) is a rapid progressive infection of the subcutaneous tissue or fascia and may result in large open wounds. The surgical options to cover these wounds are often limited by the patient condition and result in suboptimal functional and cosmetic wound coverage. Dermatotraction can restore the function and appearance of the fasciotomy wound and is less invasive in patients with comorbidities. However, dermatotraction for scarred, stiff NF fasciotomy wounds is often ineffective, resulting in skin necrosis. The authors use extended negative pressure wound therapy (NPWT) as an assist in dermatotraction to close open NF fasciotomy wounds. The authors present the clinical results, followed by a discussion of the clinical basis of extended NPWT-assisted dermatotraction. Methods A retrospective case series of eight patients with NF who underwent open fasciotomy was approved for the study. After serial wound preparation, dermatotraction was applied in a shoelace manner using elastic vessel loops. Next, the extended NPWT was applied over the wound. The sponge was three times wider than the wound width, and the transparent covering drape almost encircled the anatomical wound area. The negative pressure of the NPWT was set at a continuous 100 mmHg by suction barometer. The clinical outcome was assessed based on wound area reduction after treatment and by the achievement of direct wound closure. Results After the first set of extended NPWT-assisted dermatotraction procedures, the mean wound area was significantly decreased (658.12 cm2 to 29.37 cm2; p = 0.002), as five out of eight patients achieved direct wound closure. One patient with a chest wall defect underwent latissimus dorsi musculocutaneous flap coverage, with primary closure of the donor site. Two Fournier’s gangrene patients underwent multiple sets of treatment and finally achieved secondary wound closure with skin grafts. The patients were followed up for 18.3 months on

A Computer Spreadsheet for Locating Assistive Devices.

ERIC Educational Resources Information Center

Palmer, Catherine V.; Garstecki, Dean C.

1988-01-01

The article presents a directory of assistive devices for persons with hearing impairments in a grid format by distributor and type of device (alerting devices, telephone, TV/radio/stereo, personal communication, group communication, and other). The product locator is also available in spreadsheet form for either the Macintosh or IBM-PC computers.…

[Feasibility of device closure for multiple atrial septal defects using 3D printing and ultrasound-guided intervention technique].

PubMed

Qiu, X; Lü, B; Xu, N; Yan, C W; Ouyang, W B; Liu, Y; Zhang, F W; Yue, Z Q; Pang, K J; Pan, X B

2017-04-25

Objective: To investigate the feasibility of trans-catheter closure of multiple atrial septal defects (ASD) monitored by trans-thoracic echocardiography (TTE) under the guidance of 3D printing heart model. Methods: Between April and August 2016, a total of 21 patients (8 male and 13 female) with multiple ASD in Fuwai Hospital of Chinese Academy of Medical Sciences underwent CT scan and 3-dimensional echocardiography for heart disease model produced by 3D printing technique. The best occlusion program was determined through the simulation test on the model. Percutaneous device closure of multiple ASD was performed follow the predetermined program guided by TTE. Clinical follow-up including electrocardiogram and TTE was arranged at 1 month after the procedure. Results: The trans-catheter procedure was successful in all 21 patients using a single atrial septal occluder. Mild residual shunt was found in 5 patient in the immediate postoperative period, 3 of them were disappeared during postoperative follow-up. There was no death, vascular damage, arrhythmia, device migration, thromboembolism, valvular dysfunction during the follow-up period. Conclusion: The use of 3D printing heart model provides a useful reference for transcatheter device closure of multiple ASD achieving through ultrasound-guided intervention technique, which appears to be safe and feasible with good outcomes of short-term follow-up.

21 CFR 870.3545 - Ventricular bypass (assist) device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ventricular bypass (assist) device. 870.3545 Section 870.3545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3545 Ventricular...

21 CFR 870.3545 - Ventricular bypass (assist) device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ventricular bypass (assist) device. 870.3545 Section 870.3545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3545 Ventricular...

Intraoperative Hemodynamic and Echocardiographic Measurements Associated With Severe Right Ventricular Failure After Left Ventricular Assist Device Implantation.

PubMed

Gudejko, Michael D; Gebhardt, Brian R; Zahedi, Farhad; Jain, Ankit; Breeze, Janis L; Lawrence, Matthew R; Shernan, Stanton K; Kapur, Navin K; Kiernan, Michael S; Couper, Greg; Cobey, Frederick C

2018-06-05

Severe right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation increases morbidity and mortality. We investigated the association between intraoperative right heart hemodynamic data, echocardiographic parameters, and severe versus nonsevere RVF. A review of LVAD patients between March 2013 and March 2016 was performed. Severe RVF was defined by the need for a right ventricular mechanical support device, inotropic, and/or inhaled pulmonary vasodilator requirements for >14 days. From a chart review, the right ventricular failure risk score was calculated and right heart hemodynamic data were collected. Pulmonary artery pulsatility index (PAPi) [(pulmonary artery systolic pressure - pulmonary artery diastolic pressure)/central venous pressure (CVP)] was calculated for 2 periods: (1) 30 minutes before cardiopulmonary bypass (CPB) and (2) after chest closure. Echocardiographic data were recorded pre-CPB and post-CPB by a blinded reviewer. Univariate logistic regression models were used to examine the performance of hemodynamic and echocardiographic metrics. A total of 110 LVAD patients were identified. Twenty-five did not meet criteria for RVF. Of the remaining 85 patients, 28 (33%) met criteria for severe RVF. Hemodynamic factors associated with severe RVF included: higher CVP values after chest closure (18 ± 9 vs 13 ± 5 mm Hg; P = .0008) in addition to lower PAPi pre-CPB (1.2 ± 0.6 vs 1.7 ± 1.0; P = .04) and after chest closure (0.9 ± 0.5 vs 1.5 ± 0.8; P = .0008). Post-CPB echocardiographic findings associated with severe RVF included: larger right atrial diameter major axis (5.4 ± 0.9 vs 4.9 ± 1.0 cm; P = .03), larger right ventricle end-systolic area (22.6 ± 8.4 vs 18.5 ± 7.9 cm; P = .03), lower fractional area of change (20.2 ± 10.8 vs 25.9 ± 12.6; P = .04), and lower tricuspid annular plane systolic excursion (0.9 ± 0.2 vs 1.1 ± 0.3 cm; P = .008). Right ventricular failure risk score was not a significant predictor of

Translation and validation of the assistive technology device predisposition assessment in Greek in order to assess satisfaction with use of the selected assistive device.

PubMed

Koumpouros, Yiannis; Papageorgiou, Effie; Karavasili, Alexandra; Alexopoulou, Despoina

2017-07-01

To examine the Assistive Technology Device Predisposition Assessment scale and provide evidence of validity and reliability of the Greek version. We translated and adapted the original instrument in Greek according to the most well-known guidelines recommendations. Field test studies were conducted in a rehabilitation hospital to validate the appropriateness of the final results. Ratings of the different items were statistically analyzed. We recruited 115 subjects who were administered the Form E of the original questionnaire. The experimental analysis conducted revealed a three subscales structure: (i) Adaptability, (ii) Fit to Use, and (iii) Socializing. According to the results of our study the three subscales measure different constructs. Reliability measures (ICC = 0.981, Pearson's correlation = 0.963, Cronbach's α = 0.701) yielded high values. Test-retest outcome showed great stability. This is the first study, at least to the knowledge of the authors, which focuses merely on measuring the satisfaction of the users from the used assistive device, while exploring the Assistive Technology Device Predisposition Assessment - Device Form in such depth. According to the results, it is a stable, valid and reliable instrument and applicable to the Greek population. Thus, it can be used to measure the satisfaction of patients with assistive devices. Implications for Rehabilitation The paper explores the cultural adaptability and applicability of ATD PA - Device Form. ATD PA - Device Form can be used to assess user satisfaction by the selected assistive device. ATD PA - Device Form is a valid and reliable instrument in measuring users' satisfaction in Greekreality.

Stent-Grafts in the Management of Hemorrhagic Complications Related to Hemostatic Closure Devices: Report of Two Cases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Giansante Abud, Daniel; Mounayer, Charbel; Saint-Maurice, Jean Pierre

We report 2 cases of hemorrhagic complications related to use of the Angio-Seal hemostatic closure device that were successfully managed with stent-grafts. Two patients with subarachnoid hemorrhage were referred to our departments for endovascular treatment of ruptured intracranial aneurysms. The treatment was performed through a femoral access; the sheaths were removed immediately after the procedures, and the punctures sites closed by Angio-Seals. Both patients presented clinical signs of hypovolemic shock after treatment. The diagnosis of active bleeding through the puncture site was made by emergency digital subtraction angiography. The lesions were managed with stent-grafts. The use of stent-grafts proved tomore » be efficient in the management of these life-threatening hemorrhagic complications following the use of the Angio-Seal hemostatic closure device.« less

Endoscopic repair of an injured internal carotid artery utilizing femoral endovascular closure devices.

PubMed

Van Rompaey, Jason; Bowers, Greg; Radhakrishnan, Jay; Panizza, Benedict; Solares, C Arturo

2014-06-01

Injury to the internal carotid artery is a feared complication of endoscopic endonasal surgery of the skull base. Such an event, although rare, is associated with high morbidity and mortality. Even if bleeding is controlled, permanent neurological defects frequently persist. Many techniques have been developed to manage internal carotid artery rupture with varying degrees of success. The purpose of this study was to explore endoscopic management of arterial damage with endovascular closure devices used for a femoral arteriotomy. The ability to remotely suture a damaged artery permits the possible adaptation of this technology in managing endoscopic arterial complications. Technical note. After the creation of an endoscopic endonasal corridor in a cadaveric specimen, an arteriotomy was created at the cavernous portion of the internal carotid artery. The Angio-Seal, StarClose, and MynxGrip vascular closure devices were utilized under endoscopic guidance to repair the arteriotomy. Angiography was then done on a cadaver sutured with the StarClose. Both the Angio-Seal and StarClose were deployed quickly and appeared to provide sufficient closure of the arteriotomy. The Angio-Seal required the use of a guidewire and was longer to deploy when compared with the StarClose. The StarClose deployment was quick and facile. The MynxGrip also deployed without difficulty. The Angio-Seal and StarClose systems were both successfully deployed utilizing an endoscopic endonasal approach. The MynxGrip was the easiest to deploy and has the greatest potential to be of benefit in this application. Further studies with hemodynamic models are required to properly assess the appropriateness in this setting. NA. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Successful Retrieval of an Embolized Vascular Closure Device (Angio-Seal{sup ®}) After Peripheral Angioplasty

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jud, Philipp, E-mail: philipp.jud@medunigraz.at; Portugaller, Rupert; Bohlsen, Dennis

A 55-year-old male with peripheral arterial disease underwent angioplasty of the right lower limb arteries via antegrade femoral access. Angio-Seal{sup ®} closure device was used to treat the puncture site, whereby the intravascular sealing anchor accidentally embolized into the malleolar region of the right posterior tibial artery. Successful retrieval of the anchor was accomplished by a SpiderFX embolic protection device. This technique may be a useful approach to retrieve embolized foreign bodies via endovascular access.

Percutaneous management of coronary sinus atrial septal defect: two cases representing the spectrum for device closure and a review of the literature.

PubMed

Sandeep, Nefthi; Slack, Michael C

2014-10-01

Coronary sinus atrial septal defects are the rarest defects of the atrial septum comprising <1% of the five different types of atrial septal defects. Despite the widespread adoption of percutaneous device closure of secundum atrial septal defects, the published experience with percutaneous device closure of coronary sinus atrial septal defects is limited to only a few isolated case reports because of uncertainty regarding safety and efficacy. Open-heart surgical repair remains the treatment of choice for coronary sinus atrial septal defects, although this may not be the only treatment option in selected cases. Herein we describe our own experience with two patients with different clinical presentations and our method of successful percutaneous coronary sinus atrial septal defect closure in each. We then present a review of the anatomic spectrum of coronary sinus atrial septal defects along with a review of contemporary surgical and percutaneous device treatment.

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

A wafer-level vacuum package using glass-reflowed silicon through-wafer interconnection for nano/micro devices.

PubMed

Jin, Joo-Young; Yoo, Seung-Hyun; Yoo, Byung-Wook; Kim, Yong-Kweon

2012-07-01

We propose a vacuum wafer-level packaging (WLP) process using glass-reflowed silicon via for nano/micro devices (NMDs). A through-wafer interconnection (TWIn) substrate with silicon vias and reflowed glass is introduced to accomplish a vertical feed-through of device. NMDs are fabricated in the single crystal silicon (SCS) layer which is formed on the TWIn substrate by Au eutectic bonding including Cr adhesion layer. The WLPof the devices is achieved with the capping glass wafer anodically bonded to the SCS layer. In order to demonstrate the successful hermetic packaging, we fabricated the micro-Pirani gauge in the SCS layer, and packaged it in the wafer-level. The vacuum level inside the packaging was measured to be 3.1 Torr with +/- 0.12 Torr uncertainty, and the packaging leakage was not detected during 24 hour after the packaging.

Non-Exposure, Device-Assisted Endoscopic Full-thickness Resection.

PubMed

Bauder, Markus; Schmidt, Arthur; Caca, Karel

2016-04-01

Recent developments have expanded the frontier of interventional endoscopy toward more extended resections following surgical principles. This article presents two new device-assisted techniques for endoscopic full-thickness resection in the upper and lower gastrointestinal tract. Both methods are nonexposure techniques avoiding exposure of gastrointestinal contents to the peritoneal cavity by a "close first-cut later" principle. The full-thickness resection device is a novel over-the-scope device designed for clip-assisted full-thickness resection of colorectal lesions. Endoscopic full-thickness resection of gastric subepithelial tumors can be performed after placing transmural sutures underneath the tumor with a suturing device originally designed for endoscopic antireflux therapy. Copyright © 2016 Elsevier Inc. All rights reserved.

Device for testing closure disks at high rates of change of pressure

DOEpatents

Merten, Jr., Charles W.

1993-11-09

A device for testing the burst pressure of closure disks which provides high pressure to both sides of a disk and rapidly releases pressure from one side thereof causing a high rate of change of pressure. A hollow notched plug allows the rapid release of pressure upon rupturing. A means is also disclosed for transmitting a tensile load from a piston to a hollow notched plug and for sealing the means for transmitting load within a hole in a piston.

Transcatheter umbrella closure of valvular and paravalvular leaks.

PubMed

Hourihan, M; Perry, S B; Mandell, V S; Keane, J F; Rome, J J; Bittl, J A; Lock, J E

1992-11-15

Our aim was to adapt the technique of transcatheter umbrella closure of intracardiac defects for closure of valvular and paravalvular defects. The double-umbrella device developed by Rashkind and Cuaso has been safely and effectively delivered across a host of intracardiac defects, but transcatheter closure of valvular and paravalvular leaks has not been reported. Between February 1987 and September 1990, eight patients who were believed to be poor operative candidates were taken to the catheterization laboratory for transcatheter double-umbrella closure of a valvular or a paravalvular leak. Four patients had a paravalvular leak around a prosthetic aortic valve. The other four patients had a valvular leak: one patient with a regurgitant native aortic valve after a Stansel procedure and three patients with a regurgitant porcine valve in a left ventricular apex to descending aorta conduit. Placement of a double-umbrella device was attempted in seven of the eight patients and was successful in all seven. Device placement was not attempted in one patient because of the crescentic shape of his defect. Two patients required two devices for each closure; the other five required only one device each. Angiography, performed on six patients after device closure, demonstrated that three patients had a completely occluded defect, two had trivial residual flow and one patient had mild residual flow through the device. All significant complications occurred in one patient who had hemolysis and oliguria that resolved when the initial umbrella was replaced by a larger device. In addition, two devices migrated to the patient's pulmonary arteries but were retrieved in the catheterization laboratory without difficulty. No other early or late complications occurred in 21 to 50 months of follow-up. Of the four patients with a paravalvular leak, the one who did not receive a device died at operation, one patient died at operation for an associated defect (in the operating room the

Ethical challenges with the left ventricular assist device as a destination therapy

PubMed Central

Rizzieri, Aaron G; Verheijde, Joseph L; Rady, Mohamed Y; McGregor, Joan L

2008-01-01

The left ventricular assist device was originally designed to be surgically implanted as a bridge to transplantation for patients with chronic end-stage heart failure. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy in Medicare beneficiaries who are not candidates for heart transplantation. The use of the left ventricular assist device as a destination therapy raises certain ethical challenges. Left ventricular assist devices can prolong the survival of average recipients compared with optimal medical management of chronic end-stage heart failure. However, the overall quality of life can be adversely affected in some recipients because of serious infections, neurologic complications, and device malfunction. Left ventricular assist devices alter end-of-life trajectories. The caregivers of recipients may experience significant burden (e.g., poor physical health, depression, anxiety, and posttraumatic stress disorder) from destination therapy with left ventricular assist devices. There are also social and financial ramifications for recipients and their families. We advocate early utilization of a palliative care approach and outline prerequisite conditions so that consenting for the use of a left ventricular assist device as a destination therapy is a well informed process. These conditions include: (1) direct participation of a multidisciplinary care team, including palliative care specialists, (2) a concise plan of care for anticipated device-related complications, (3) careful surveillance and counseling for caregiver burden, (4) advance-care planning for anticipated end-of-life trajectories and timing of device deactivation, and (5) a plan to address the long-term financial burden on patients, families, and caregivers. Short-term mechanical circulatory devices (e.g. percutaneous cardiopulmonary

Natural vacuum electronics

NASA Technical Reports Server (NTRS)

Leggett, Nickolaus

1990-01-01

The ambient natural vacuum of space is proposed as a basis for electron valves. Each valve is an electron controlling structure similiar to a vacuum tube that is operated without a vacuum sustaining envelope. The natural vacuum electron valves discussed offer a viable substitute for solid state devices. The natural vacuum valve is highly resistant to ionizing radiation, system generated electromagnetic pulse, current transients, and direct exposure to space conditions.

Vascular closure devices in stroke patients receiving tissue plasminogen activator: A retrospective analysis from an academic tertiary medical center and a teaching community hospital stroke database.

PubMed

Patil, Mangaladevi S; Jayaraman, Mahesh V; Ahn, Sun H

2017-06-01

To determine the safety and effectiveness of vascular closure devices in prevention of access site complications in acute stroke patient receiving intravenous (IV) and/or intra-arterial (IA) IV tissue plasminogen activator (tPA). All patients with acute stroke onset treated with IV and/or IA tPA closed with vascular closure device and adult age (>18 years) were identified from an academic tertiary medical center and a teaching community hospital stroke database for 9 years (from March 2005 to June 2014). A total of 69 patients were included in the study. The mean age was 68.86±16.70 years and 49.2% female. All accesses were under fluoroscopic guidance into the right common femoral artery. We observed a 5.8% complication rate in patients receiving IV and/or IA tPA closed with vascular closure device. Access site complications included 3 cases of hematoma and 1 case of residual oozing. One patient required transfusion due to access site hematoma. Three patients were on aspirin and heparin and 1 was on no prior anticoagulation. Vascular closure device access site hemorrhagic complication rate in those receiving IV and/or IA tPA is low and similar to reported rates in those not receiving thrombolytic therapy. Vascular closure device use in patients receiving thrombolytic therapy is safe and effectively achieves hemostasis. Copyright © 2017 Elsevier B.V. All rights reserved.

Simulating Ideal Assistive Devices to Reduce the Metabolic Cost of Running

PubMed Central

Uchida, Thomas K.; Seth, Ajay; Pouya, Soha; Dembia, Christopher L.; Hicks, Jennifer L.; Delp, Scott L.

2016-01-01

Tools have been used for millions of years to augment the capabilities of the human body, allowing us to accomplish tasks that would otherwise be difficult or impossible. Powered exoskeletons and other assistive devices are sophisticated modern tools that have restored bipedal locomotion in individuals with paraplegia and have endowed unimpaired individuals with superhuman strength. Despite these successes, designing assistive devices that reduce energy consumption during running remains a substantial challenge, in part because these devices disrupt the dynamics of a complex, finely tuned biological system. Furthermore, designers have hitherto relied primarily on experiments, which cannot report muscle-level energy consumption and are fraught with practical challenges. In this study, we use OpenSim to generate muscle-driven simulations of 10 human subjects running at 2 and 5 m/s. We then add ideal, massless assistive devices to our simulations and examine the predicted changes in muscle recruitment patterns and metabolic power consumption. Our simulations suggest that an assistive device should not necessarily apply the net joint moment generated by muscles during unassisted running, and an assistive device can reduce the activity of muscles that do not cross the assisted joint. Our results corroborate and suggest biomechanical explanations for similar effects observed by experimentalists, and can be used to form hypotheses for future experimental studies. The models, simulations, and software used in this study are freely available at simtk.org and can provide insight into assistive device design that complements experimental approaches. PMID:27656901

Device for testing closure disks at high rates of change of pressure

DOEpatents

Merten, C.W. Jr.

1993-11-09

A device is described for testing the burst pressure of closure disks which provides high pressure to both sides of a disk and rapidly releases pressure from one side thereof causing a high rate of change of pressure. A hollow notched plug allows the rapid release of pressure upon rupturing. A means is also disclosed for transmitting a tensile load from a piston to a hollow notched plug and for sealing the means for transmitting load within a hole in a piston. 5 figures.

Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder).

PubMed

Taaffe, Margaret; Fischer, Evelyn; Baranowski, Andreas; Majunke, Nicolas; Heinisch, Corinna; Leetz, Michaela; Hein, Ralph; Bayard, Yves; Büscheck, Franziska; Reschke, Madlen; Hoffmann, Ilona; Wunderlich, Nina; Wilson, Neil; Sievert, Horst

2008-05-01

This randomized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale (PFO) closure devices (Amplatzer, Helex, and CardioSEAL-STARflex). It examined 660 patients (361 men, 299 women, mean age 49.3+/-1.9 years), with 220 patients per group. All patients had a history of paradoxical embolism. All PFO closures were successful technically. Exchange of devices for others was most frequently required for the Helex occluder (7 of 220) and 2 of 220 in either of the other groups. Three device embolizations in the Helex group were retrieved and replaced successfully. One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment. A hemopericardium in that group was punctured without affecting the device. One tamponade in the Amplatzer group required surgical device explantation. In 8 of 660 patients in the CardioSEAL-STARflex group, thrombi resolved after anticoagulation. Sixteen patients (11 in the CardioSEAL-STARflex group, 3 in the Amplatzer group, and 2 in the Helex group) had episodes of atrial fibrillation. PFOs were closed completely in 143 of 220 patients (65%) in the Amplatzer group, 116 of 220 patients (52.7%) in the Helex group, and 137 of 220 patients (62.3%) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders (p=0.0005) and the Helex and CardioSEAL-STARflex occluders (p=0.0003). PFO closure can be performed safely with each device. In conclusion, the Helex occluder embolized more frequently. Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder.

Vacuum sealing drainage therapy in the presence of an external fixation device

PubMed Central

Sun, Dahui; Ju, Weina; Wang, Tiejun; Yu, Tiecheng; Qi, Baochang

2016-01-01

Abstract Rationale: Vacuum sealing drainage (VSD) is widely utilized for treating traumatic wounds. Patient concerns: It is particularly difficult and time consuming to use in combination with an external fixator. Diagnoses: This is because the hardware or pins used for fixation interfere with maintaining a seal, resulting in poor adhesion and subsequent air leakage. Interventions: To resolve this problem, we have devised a new method for sealing the wound dressing, while maintaining the required vacuum.When using this technique, a rubber strip is wrapped around each pin in 3 circles outside the plastic drape, and then tightly tied. Outcomes: After completing this procedure, a vacuum is obtained, and any air leakage stops. We employed this technique to treat a cohort of patients in our department over a period of two years, and obtained good healing of soft tissue without air leakage, as well as good clinical outcomes. Lessons: We have observed that patients treated with this method experienced good clinical outcomes without air leakage, and we recommend its use in treating cases where an external fixation device is present. PMID:27861393

Short-Term Safety and Efficacy of Femoral Vascular Closure after Percutaneous Coronary Intervention with Combination of the Boomerang(TM) Device and Intravenous Protamine Sulfate.

PubMed

Chen, Ching-Pei; Huang, Huang-Kai; Hsia, Chien-Hsun; Chang, Yung-Ming; Lin, Lee-Shin; Lee, Cheng-Liang

2013-11-01

The Cardiva Boomerang(TM) is a device used to perform femoral vascular closure. It facilitates passive hemostasis at the arteriotomy site, leaving no residual foreign body. We performed a controlled, randomized study of 60 patients undergoing percutaneous coronary intervention. Patients were randomized into two groups (30 per group) to undergo vascular closure with the Boomerang(TM) or the Perclose(TM) suture-based device after the intravenous administration of protamine sulfate. We compared overall success rates, patient-reported pain, length of time to achieve hemostasis and mobilization of the patient, and the frequency of complications in the two groups. Overall success rates using the Boomerang(TM) and Perclose(TM) devices were similarly high, at 93% and 97%, respectively. The Boomerang(TM) was significantly quicker to deploy than the PercloseTM, device deployment time, median (Q1-Q3), [2.00 (1.33-2.75) vs. 3.84 (2.75-4.38) mins, p < 0.001)]. The pain score was significantly lower in the Boomerang(TM) group (1.1 ± 1.7 vs. 6.4 ± 2.9, p < 0.001). The time the device remained in the artery and manual compression time were significantly longer with the Boomerang(TM) (p < 0.001), as well as the time taken to achieve hemostasis and time to ambulation. There were no major complications in either group and no significant differences between the groups in the frequency of minor complications. We conclude that when used in combination with intravenous protamine sulfate, the Boomerang(TM) device is as safe and effective as the Perclose(TM) device for femoral vascular closure, but quicker to deploy and less painful to patients. Boomerang; Percutaneous intervention; Vascular closure device.

Papilloma diagnosed at MRI-guided vacuum-assisted breast biopsy: is surgical excision still warranted?

PubMed

Brennan, Sandra B; Corben, Adriana; Liberman, Laura; Dershaw, D David; Brogi, Edi; Van Zee, Kimberly J; Morris, Elizabeth

2012-10-01

The objective of our study was to determine the frequency of cancer at surgery in breast lesions yielding papilloma at MRI-guided 9-gauge vacuum-assisted biopsy (VAB) and to determine whether any features are associated with cancer upgrade. For this study, 1487 MRI-guided vacuum-assisted biopsies performed from January 2004 to March 2011 were reviewed. Lesions yielding papilloma were identified and classified as papilloma with or without atypia. Surgical findings were reviewed to determine the cancer rate. Statistical analysis was performed and 95% CIs were calculated. Papilloma was identified in 75 of the 1487 MRI-guided vacuum-assisted biopsies (5%). These 75 papillomas occurred in 73 women with a median age of 49 years (age range, 27-70 years). Of the 75 papillomas, 25 (33%) had atypia and 50 (67%) did not on core needle biopsy. Subsequent surgery of 67 of the 75 papillomas (89%) yielded ductal carcinoma in situ (DCIS) in four (6%; 95% CI, 2-15%). Surgery yielded DCIS in two of 23 papillomas with atypia (9%; 95% CI, 1-28%) at MRI-guided VAB and in two of 44 papillomas without atypia (5%; 95% CI, 0.4-16%) at MRI-guided VAB; these cancer rates did not differ significantly (p=0.6). Postmenopausal status (p=0.04) and histologic size of less than 0.2 cm (p=0.04) had a significant association with the cancer upgrade rate. Papilloma with or without atypia was found in 5% of patients who underwent MRI-guided VAB during the study period. Surgery revealed cancer in 6%. DCIS was found at surgery in 9% of lesions yielding papilloma with atypia versus 5% of lesions yielding papilloma without atypia. For lesions yielding papilloma with or without atypia at MRI-guided VAB, surgical excision is warranted.

Cost-effectiveness analysis of different devices used for the closure of small-to-medium-sized patent ductus arteriosus in pediatric patients

PubMed Central

El-Saiedi, Sonia A; El Sisi, Amal M; Mandour, Rodina Sobhy; Abdel-Aziz, Doaa M; Attia, Wael A

2017-01-01

Aims: In this study, we examined the differences in cost and effectiveness of various devices used for the closure of small to medium sized patent ductus arteriosus (PDA). Setting and Design: We retrospectively studied 116 patients who underwent closure of small PDAs between January 2010 and January 2015. Subjects and Methods: Three types of devices were used: the Amplatzer duct occluder (ADO) II, the cook detachable coil and the Nit Occlud coil (NOC). Immediate and late complications were recorded and patients were followed up for 3 months after the procedure. Statistical Methods: All statistical calculations were performed using Statistical Package for the Social Science software. P <0.05 were considered significant. Results: We successfully deployed ADO II devices in 33 out of 35 cases, cook detachable coils in 36 out of 40 cases and NOCs in 38 out of 41 cases. In the remaining nine cases, the first device was unsuitable or embolized and required retrieval and replacement with another device. Eleven patients (9.5%) developed vascular complications and required anticoagulation therapy. Patients who had hemolysis or vascular complications remained longer in the intensive care unit, with consequently higher total cost (P = 0.016). Also, the need for a second device increased the cost per patient. Conclusions: The cook detachable coil is the most cost-effective device for closure of small-to medium-sized PDAs. Calculations of the incremental cost-effectiveness. (ICE) revealed that the Cook detachable coil had less ICE than the ADO II and NOC. The NOC was more effective with fewer complications. PMID:28566822

Is the new Occlutech duct occluder an appropriate device for transcatheter closure of patent ductus arteriosus?

PubMed

Godart, François; Houeijeh, Ali; Domanski, Olivia; Guillaume, Marie-Paule; Brard, Mélanie; Lucron, Hugues

2018-06-15

To describe our initial experience with the Occlutech Duct Occluder (ODO) for percutaneous closure of patent ductus arteriosus (PDA). Retrospective review of patients undergoing transcatheter PDA closure with the ODO in 2 academic centers. From April 2013 to September 2017, 42 patients underwent PDA closure. Median age at implantation was 34 months (range 4 months-68 years) and median weight was 12 kg (range 4.1-57 kg). Ducts were Krichenko type A duct (n = 34), type E (n = 6), and type C (n = 2). The mean duct diameter was 3.76 mm (range 1.69 to 9.95 mm, median 3.1 mm). Implantation succeeded in all. There was neither device embolization nor hemolysis. At device release, immediate angiogram showed a small residual shunt in 54.7%. During follow-up, Doppler echocardiography demonstrated 71% of full occlusion at day one, rising to 95% at one month and 100% at one year and half after implantation. The mean maximal systolic pressure gradient in left pulmonary artery was 4.2 ± 4.3 mm and across the distal aortic arch 5.4 ± 4.7 mm Hg. No patient had any significant stenosis with clinical relevance. ODO is safe and effective in transcatheter closure of PDA including relatively large sized ducts. The results are satisfactory with a high level of full occlusion and a low rate of complications. Further evaluation with larger studies and longer follow-up will be required to confirm these preliminary good results. Copyright © 2018. Published by Elsevier B.V.

Matrix Assisted Ionization Vacuum (MAIV), a New Ionization Method for Biological Materials Analysis Using Mass Spectrometry*

PubMed Central

Inutan, Ellen D.; Trimpin, Sarah

2013-01-01

The introduction of electrospray ionization (ESI) and matrix-assisted laser desorption/ionization (MALDI) for the mass spectrometric analysis of peptides and proteins had a dramatic impact on biological science. We now report that a wide variety of compounds, including peptides, proteins, and protein complexes, are transported directly from a solid-state small molecule matrix to gas-phase ions when placed into the vacuum of a mass spectrometer without the use of high voltage, a laser, or added heat. This ionization process produces ions having charge states similar to ESI, making the method applicable for high performance mass spectrometers designed for atmospheric pressure ionization. We demonstrate highly sensitive ionization using intermediate pressure MALDI and modified ESI sources. This matrix and vacuum assisted soft ionization method is suitable for the direct surface analysis of biological materials, including tissue, via mass spectrometry. PMID:23242551

Device Management and Flow Optimization on Left Ventricular Assist Device Support.

PubMed

Tchoukina, Inna; Smallfield, Melissa C; Shah, Keyur B

2018-07-01

The authors discuss principles of continuous flow left ventricular assist device (LVAD) operation, basic differences between the axial and centrifugal flow designs and hemodynamic performance, normal LVAD physiology, and device interaction with the heart. Systematic interpretation of LVAD parameters and recognition of abnormal patterns of flow and pulsatility on the device interrogation are necessary for clinical assessment of the patient. Optimization of pump flow using LVAD parameters and echocardiographic and hemodynamics guidance are reviewed. Copyright © 2018 Elsevier Inc. All rights reserved.

Transapical access closure: the TA PLUG device†

PubMed Central

Brinks, Henriette; Nietlispach, Fabian; Göber, Volkhard; Englberger, Lars; Wenaweser, Peter; Meier, Bernhard; Carrel, Thierry; Huber, Christoph

2013-01-01

OBJECTIVES Percutaneous closure of the transapical (TA) access site for large-calibre devices is an unsolved issue. We report the first experimental data on the TA PLUG device for true-percutaneous closure following large apical access for transcatheter aortic valve implantation. METHODS The TA PLUG, a self-sealing full-core closure device, was implanted in an acute animal study in six pigs (60.2 ± 0.7 kg). All the pigs received 100 IU/kg of heparin. The targeted activated clotting time was left to normalize spontaneously. After accessing the left ventricular apex with a 39 French introducer, the closure plug device was delivered with a 33 French over-the-wire system under fluoroscopic guidance into the apex. Time to full haemostasis as well as rate of bleeding was recorded. Self-anchoring properties were assessed by haemodynamic push stress under adrenalin challenge. An additional feasibility study was conducted in four pigs (58.4 ± 1.1 kg) with full surgical exposure of the apex, and assessed device anchoring by pull-force measurements with 0.5 Newton (N) increments. All the animals were electively sacrified. Post-mortem analysis of the heart was performed and the renal embolic index assessed. RESULTS Of six apical closure devices, five were correctly inserted and fully deployed at the first attempt. One became blocked in the delivery system and was placed successfully at the second attempt. In all the animals, complete haemostasis was immediate and no leak was recorded during the 5-h observation period. Neither leak nor any device dislodgement was observed under haemodynamic push stress with repeated left ventricular peak pressure of up to 220 mmHg. In the feasibility study assessing pull-stressing, device migration occurred at a force of 3.3 ± 0.5 N corresponding to 247.5 mmHg. Post-mortem analyses confirmed full expansion of all devices at the intended target. No macroscopic damage was identified at the surrounding myocardium. The renal embolic index was

Assistive obstacle detection and navigation devices for vision-impaired users.

PubMed

Ong, S K; Zhang, J; Nee, A Y C

2013-09-01

Quality of life for the visually impaired is an urgent worldwide issue that needs to be addressed. Obstacle detection is one of the most important navigation tasks for the visually impaired. In this research, a novel range sensor placement scheme is proposed in this paper for the development of obstacle detection devices. Based on this scheme, two prototypes have been developed targeting at different user groups. This paper discusses the design issues, functional modules and the evaluation tests carried out for both prototypes. Implications for Rehabilitation Visual impairment problem is becoming more severe due to the worldwide ageing population. Individuals with visual impairment require assistance from assistive devices in daily navigation tasks. Traditional assistive devices that assist navigation may have certain drawbacks, such as the limited sensing range of a white cane. Obstacle detection devices applying the range sensor technology can identify road conditions with a higher sensing range to notify the users of potential dangers in advance.

Assistive Financing for Assistive Devices: Loan Guarantees for Purchase of Products by Persons with Disabilities. EIF/REC Review Paper.

ERIC Educational Resources Information Center

Reeb, Kenneth G., Jr.

This paper introduces the concept of assistive financing for assistive devices for persons with disabilities, and describes model programs that have pioneered implementation of the concept in the assistive device marketplace. The assistive financing or loan guarantee concept is presented as a partnership between a private financial institution and…

Evaluation of Automated Flagger Assistance Devices

DOT National Transportation Integrated Search

2018-02-01

Automated flagger assistance devices (AFADs) are designed to improve worker safety by replacing flaggers who are typically located near traffic approaching a work zone. In this study, a new AFAD developed by the Missouri Department of Transportation ...

Beyond the hearing aid: Assistive listening devices

NASA Astrophysics Data System (ADS)

Holmes, Alice E.

2003-04-01

Persons with hearing loss can obtain great benefit from hearing aids but there are many situations that traditional amplification devices will not provide enough help to ensure optimal communication. Assistive listening and signaling devices are designed to improve the communication of the hearing impaired in instances where traditional hearing aids are not sufficient. These devices are designed to help with problems created by listening in noise or against a competing message, improve distance listening, facilitate group conversation (help with problems created by rapidly changing speakers), and allow independence from friends and family. With the passage of the Americans with Disabilities Act in 1990, assistive listening devices (ALDs) are becoming more accessible to the public with hearing loss. Employers and public facilities must provide auxiliary aids and services when necessary to ensure effective communication for persons who are deaf or hard of hearing. However many professionals and persons with hearing loss are unaware of the various types and availability of ALDs. An overview of ALDs along with a discussion of their advantages and disadvantages will be given.

50 CFR 622.43 - Closures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... following closure restrictions apply (See § 622.49 for closure provisions when an ACL is reached or... quota specified in § 622.42, or the ACL specified in 622.49, being reached and subsequent data indicate that the quota or ACL was not reached, the Assistant Administrator may file a notification to that...

Cost effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin

PubMed Central

Reddy, Vivek Y.; Akehurst, Ronald L.; Armstrong, Shannon O.; Amorosi, Stacey L.; Brereton, Nic; Hertz, Deanna S.; Holmes, David R.

2016-01-01

Abstract Aims Atrial fibrillation (AF) patients with contraindications to oral anticoagulation have had few options for stroke prevention. Recently, a novel oral anticoagulant, apixaban, and percutaneous left atrial appendage closure (LAAC) have emerged as safe and effective therapies for stroke risk reduction in these patients. This analysis assessed the cost effectiveness of LAAC with the Watchman device relative to apixaban and aspirin therapy in patients with non-valvular AF and contraindications to warfarin therapy. Methods and results A cost-effectiveness model was constructed using data from three studies on stroke prevention in patients with contraindications: the ASAP study evaluating the Watchman device, the ACTIVE A trial of aspirin and clopidogrel, and the AVERROES trial evaluating apixaban. The cost-effectiveness analysis was conducted from a German healthcare payer perspective over a 20-year time horizon. Left atrial appendage closure yielded more quality-adjusted life years (QALYs) than aspirin and apixaban by 2 and 4 years, respectively. At 5 years, LAAC was cost effective compared with aspirin with an incremental cost-effectiveness ratio (ICER) of €16 971. Left atrial appendage closure was cost effective compared with apixaban at 7 years with an ICER of €9040. Left atrial appendage closure was cost saving and more effective than aspirin and apixaban at 8 years and remained so throughout the 20-year time horizon. Conclusions This analysis demonstrates that LAAC with the Watchman device is a cost-effective and cost-saving solution for stroke risk reduction in patients with non-valvular AF who are at risk for stroke but have contraindications to warfarin. PMID:26838691

Assistive Devices: MedlinePlus Health Topic

MedlinePlus

... dressed. Some are high-tech tools, such as computers. Others are much simpler, like a "reacher" - a tool that helps you grab an object you can't reach. Learn More ... For What Conditions Are Assistive Devices Used? (National ...

Percutaneous Steerable Robotic Tool Delivery Platform and Metal MEMS Device for Tissue Manipulation and Approximation: Closure of Patent Foramen Ovale in an Animal Model

PubMed Central

Vasilyev, Nikolay V.; Gosline, Andrew H.; Butler, Evan; Lang, Nora; Codd, Patrick J.; Yamauchi, Haruo; Feins, Eric N.; Folk, Chris R.; Cohen, Adam L.; Chen, Richard; Zurakowski, David; del Nido, Pedro J.; Dupont, Pierre E

2013-01-01

Background Beating-heart image-guided intracardiac interventions have been evolving rapidly. To extend the domain of catheter-based and transcardiac interventions into reconstructive surgery, a new robotic tool delivery platform (TDP) and tissue approximation device have been developed. Initial results employing these tools to perform patent foramen ovale (PFO) closure are described. Methods and Results A robotic TDP comprised of superelastic metal tubes provides the capability of delivering and manipulating tools and devices inside the beating heart. A new device technology is also presented that utilizes a metal-based MicroElectroMechanical Systems (MEMS) manufacturing process to produce fully-assembled and fully-functional millimeter-scale tools. As a demonstration of both technologies, a PFO creation and closure was performed in a swine model. In the first group of animals (N=10), a preliminary study was performed. The procedural technique was validated with a transcardiac handheld delivery platform and epicardial echocardiography, video-assisted cardioscopy and fluoroscopy. In the second group (N=9), the procedure was performed percutaneously using the robotic TDP under epicardial echocardiography and fluoroscopy imaging. All PFO’s were completely closed in the first group. In the second group, the PFO was not successfully created in 1 animal, and the defects were completely closed in 6 of the 8 remaining animals. Conclusions In contrast to existing robotic catheter technologies, the robotic TDP utilizes a combination of stiffness and active steerability along its length to provide the positioning accuracy and force application capability necessary for tissue manipulation. In combination with a MEMS tool technology, it can enable reconstructive procedures inside the beating heart. PMID:23899870

Involving children in the development of assistive technology devices.

PubMed

Allsop, M; Gallagher, J; Holt, R; Bhakta, B; Wilkie, R M

2011-01-01

To investigate the implementation of a web-based survey for involving children in the design of assistive technology devices within the primary school environment. Children were recruited within their normal school environment. They completed tasks within the survey that sought to gather their personal preferences about assistive technology devices. From six primary schools, 257 children (mean age = 9 years and 8 months, SD = 1.51; 123 males, 134 females) including children with cerebral palsy (N = 11), varying levels of deafness (N = 7), global developmental delay (N = 2) and Down's syndrome (N = 1) participated. Observations were taken whilst the children completed the survey tasks. All children were able to complete the tasks from the survey, although children with disabilities had higher completion times and most required a form of assistance from support assistants and/or sign language interpreters. The use of the web-based survey provided a novel means with which to involve children with and without disabilities in the design of assistive technology devices within a primary school environment. In order for the survey to be utilised more widely, issues that arose when involving children with disabilities need to be addressed.

Institutional Cost Comparison Between Heart Transplants and Left Ventricular Assist Device Implantations.

PubMed

Chimanji, Neeraj; Kilic, Arman; Hasan, Ayesha; Higgins, Robert S D; Whitson, Bryan A; Kilic, Ahmet

2016-12-01

Increased numbers of end-stage heart failure patients and improved technology have led to increased use of left ventricular assist devices as a viable alternative to heart transplants. Given the current economic climate, we compared costs of heart transplant versus device placement. Medical records of patients who received heart transplants or left ventricular assist devices were cross-referenced with institutional financial data. The device cohort was limited to those receiving durable (not temporary) devices. Index admission, 1-year readmission, and overall 1-year charges were compared using standard statistical methods. Of 184 identified patients with end-stage heart failure surgical therapy, 121 received left ventricular assist devices, 43 had heart transplants, and 20 received left ventricular assist devices as bridge to heart transplant; these latter patients were excluded from our analyses. At index admission, mean charges were $863 433 ± $398 427 for device patients and $725 877 ± $488 685 for transplant patients (P = .05). One-year mean readmission rates were similar (4.65/transplant patient and 4.53/device patient; P = .94), with corresponding 1-year survival rates of 87.8% and 78.0% (P = .04). Total readmission charges during year 1 were $169 732 ± $242 366 for device patients and $201 682 ± $297 565 for transplant patients (P = .08), with corresponding overall charges at 1 year of $1 029 732 ± $450 498 and $927 559 ± $562 404 (P = .49). During the first year, heart transplant and left ventricular assist device placement have similar costs. Initial index admission costs seem to favor heart transplant, with device pump costs accounting for some of the difference. From a 1-year survival perspective, heart transplant may be more effective; however, with lack of suitable donors, left ventricular assist devices are valuable in the armamentarium of advanced heart failure surgical options.

Novel Method for Exchange of Impella Circulatory Assist Catheter: The "Trojan Horse" Technique.

PubMed

Phillips, Colin T; Tamez, Hector; Tu, Thomas M; Yeh, Robert W; Pinto, Duane S

2017-07-01

Patients with an indwelling Impella may require escalation of hemodynamic support or exchange to another circulatory assistance platform. As such, preservation of vascular access is preferable in cases where anticoagulation cannot be discontinued or to facilitate exchange to an alternative catheter or closure device. Challenges exist in avoiding bleeding and loss of wire access in these situations. We describe a single-access "Trojan Horse" technique that minimizes bleeding while maintaining arterial access for rapid exchange of this percutaneous ventricular assist device.

Closure Devices for Iatrogenic Thoraco-Cervical Vascular Injuries

DOE Office of Scientific and Technical Information (OSTI.GOV)

Makris, Gregory C., E-mail: g.makris09@doctors.org.uk; Patel, Rafiuddin; Little, Mark

IntroductionThe unintentional arterial placement of a central venous line can have catastrophic complications. The purpose of this systematic review is to assess and analyse the available evidence regarding the use of the various vascular closure devices (VCDs) for the management of iatrogenic thoraco-cervical arterial injuries (ITCAI).MethodsA systematic review was performed according to PRISMA guidelines.ResultsThirty-two relevant case series and case reports were identified with a total of 69 patients having being studied. In the majority of the studies, plug-based VCDs were used (81%) followed by suture-based devices (19%). The majority of studies reported successful outcomes from the use of VCDs inmore » terms of achieving immediate haemostasis without any acute complications. Long-term follow-up data were only available in nine studies with only one case of carotid pseudoaneurysm being reported after 1-month post-procedure. All other cases had no reported long-term complications. Five studies performed direct or indirect comparisons between VCDs and other treatments (open surgery or stent grafting) suggesting no significant differences in safety or effectiveness.ConclusionAlthough there is limited evidence, VCDs appear to be safe and effective for the management of ITCAIs. Further research is warranted regarding the effectiveness of this approach in comparison to surgery and in order to identify those patients who are more likely to benefit from this minimally invasive approach.« less

Biomechanical Testing and Histologic Examination of Intradermal Skin Closure in Dogs Using Barbed Suture Device and Non-Barbed Monofilament Suture.

PubMed

Law, Andy Y; Butler, James R; Patnaik, Sourav S; Cooley, James A; Elder, Steven H

2017-01-01

To compare the biomechanical strength and histologic features of 3-0 Glycomer™ 631 barbed suture (V-LOC™ 90 Absorbable Wound Closure Device, Covidien, Mansfield, MA) to non-barbed 3-0 Glycomer™ 631 suture (Biosyn™, Covidien) for intradermal skin wound closure in the dog. Randomized, factorial, in vivo. Eighteen purpose-bred, mature male, and female hound dogs. Eighteen adult hound dogs were randomly assigned to 1 of 3 groups designated by postoperative day of assessment. Six skin incisions were made along the dorsum in the thoracolumbar region of each dog with an equal number (n=3) randomly assigned to closure with barbed or non-barbed suture. Six dogs were euthanatized on postoperative days 3, 10, and 14, respectively. Two additional incisions were made on each dog after euthanasia for baseline data (Day 0). The skin incision specimens were harvested for biomechanical testing and histologic evaluation. Non-barbed closure had significantly higher maximum load at failure (P<.001) and stiffness (P<.001) than barbed closure regardless of day. The average tissue reaction score was significantly higher for barbed closure (P=.008), regardless of day. Suturing time for barbed closures was significantly shorter. There was no significant difference in frequency of complications between closures. Barbed Glycomer™ 631 closures had a significantly lower maximum load at failure and stiffness, and higher average tissue reaction scores, but showed no difference in short term outcome for intradermal closure of dorsally located skin incisions in dogs. © 2016 The American College of Veterinary Surgeons.

Post-Vacuum-Assisted Stereotactic Core Biopsy Clip Displacement: A Comparison Between Commercially Available Clips and Surgical Clip.

PubMed

Yen, Peggy; Dumas, Sandra; Albert, Arianne; Gordon, Paula

2018-02-01

The placement of localization clips following percutaneous biopsy is a standard practice for a variety of situations. Subsequent clip displacement creates challenges for imaging surveillance and surgical planning, and may cause confusion amongst radiologists and between surgeons and radiologists. Many causes have been attributed for this phenomenon including the commonly accepted "accordion effect." Herein, we investigate the performance of a low cost surgical clip system against 4 commercially available clips. We retrospectively reviewed 2112 patients who underwent stereotactic vacuum-assisted core biopsy followed by clip placement between January 2013 and June 2016. The primary performance parameter compared was displacement >10 mm following vacuum-assisted stereotactic core biopsy. Within the group of clips that had displaced, the magnitude of displacement was compared. There was a significant difference in displacement among the clip types (P < .0001) with significant pairwise comparisons between pediatric surgical clips and SecureMark (38% vs 28%; P = .001) and SenoMark (38% vs 27%; P = .0001) in the proportion displaced. The surgical clips showed a significant magnitude of displacement of approximately 25% greater average distance displaced. As a whole, the commercial clips performed better than the surgical clip after stereotactic vacuum-assisted core biopsy suggesting the surrounding outer component acts to anchor the central clip and minimizes clip displacement. The same should apply to tomosynthesis-guided biopsy. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

[Closure of wide patent ductus arteriosus using a fenestrated muscular VSD occluder device in a pediatric patient with Down syndrome and pulmonary hypertension].

PubMed

Güvenç, Osman; Saygı, Murat; Demir, İbrahim Halil; Ödemiş, Ender

2017-06-01

Patients with wide patent ductus arteriosus and significant pulmonary hypertension not treated in time constitute a significant problem for cardiologists. For these patients, tests that could aid in decision-making for further planning include reversibility and balloon occlusion tests performed in the catheterization laboratory. Devices developed for the closure of ductus as well as different devices with off-label use may be employed in patients scheduled for transcatheter occlusion. When result of reversibility test is borderline positive, the use of fenestrated device may be applicable for selected patients. Presently described is case of a 10-year-old patient with Down syndrome who had a wide ductus and systemic pulmonary hypertension. Transcatheter closure procedure was performed with off-label use of a fenestrated muscular ventricular septal defect occluder device.

Comparing the Tolerability of a Novel Wound Closure Device Using a Porcine Wound Model

PubMed Central

Townsend, Katy L.; Akeroyd, Jen; Russell, Duncan S.; Kruzic, Jamie J.; Robertson, Bria L.; Lear, William

2018-01-01

Objective: To compare the tolerability and mechanical tensile strength of acute skin wounds closed with nylon suture plus a novel suture bridge device (SBD) with acute skin wounds closed with nylon suture in a porcine model. Approach: Four Yucatan pigs each received 12 4.5 cm full-thickness incisions that were closed with 1 of 4 options: Suture bridge with nylon, suture bridge with nylon and subdermal polyglactin, nylon simple interrupted, and nylon simple interrupted with subdermal polyglactin. Epithelial reaction, inflammation, and scarring were examined histologically at days 10 and 42. Wound strength was examined mechanically at days 10 and 42 on ex vivo wounds from euthanized pigs. Results: Histopathology in the suture entry/exit planes showed greater dermal inflammation with a simple interrupted nylon suture retained for 42 days compared with the SBD retained for 42 days (p < 0.03). While tensile wound strength in the device and suture groups were similar at day 10, wounds closed with the devices were nearly 8 times stronger at day 42 compared with day 10 (p < 0.001). Innovation: A novel SBD optimized for cutaneous wound closure that protects the skin surface from suture strands, forms a protective bridge over the healing wound edges, and knotlessly clamps sutures. Conclusion: This study suggests that the use of a SBD increases the tolerability of nylon sutures in porcine acute skin wound closures allowing for prolonged mechanical support of the wound. For slow healing wounds, this may prevent skin wound disruption, such as edge necrosis and dehiscence. PMID:29892494

Successful use of a left ventricular apical access and closure device for second-generation transapical aortic valve implantation.

PubMed

Conradi, Lenard; Seiffert, Moritz; Shimamura, Kazuo; Schirmer, Johannes; Blankenberg, Stefan; Reichenspurner, Hermann; Diemert, Patrick; Treede, Hendrik

2014-09-01

Transcatheter aortic valve implantation (TAVI) has become routine for the treatment of high-risk patients with aortic stenosis. We assessed safety and feasibility of a left ventricular apical access and closure device combined with second-generation transapical (TA) TAVI transcatheter heart valves (THV). Three elderly, comorbid patients (logEuroSCORE I 13.0-31.1%) received transapical aortic valve implantation (TA-AVI) via the Apica ASC device (Apica Cardiovascular Ltd., Galway, Ireland) using second-generation THV (Medtronic Engager [Medtronic 3F Therapeutics, Santa Ana, California, United States], JenaValve [JenaValve Technology GmbH, Munich, Germany], Symetis Acurate [Symetis S.A., Ecublens, Switzerland]). Access was gained using a non-rib-spreading technique and a novel access and closure device. THV deployment was successful with excellent hemodynamic outcome (no PVL, n = 2; trace PVL, n = 1; mean transvalvular gradients, 5-19 mm Hg) and complete apical hemostasis. No periprocedural major adverse events occurred and Valve Academic Research Consortium-2-defined composite end point of device success was met in all cases. Safety and feasibility of TA-AVI using the ASC device with second-generation THV was demonstrated. Combining latest available technology is a major step toward improved functional outcome and decreased surgical trauma in TA-AVI. Potentially, technical enhancements may eventually pave the way toward a fully percutaneous TA-AVI procedure. Georg Thieme Verlag KG Stuttgart · New York.

Left ventricular assist devices as destination therapy: a new look at survival.

PubMed

Park, Soon J; Tector, Alfred; Piccioni, William; Raines, Edward; Gelijns, Annetine; Moskowitz, Alan; Rose, Eric; Holman, William; Furukawa, Satoshi; Frazier, O Howard; Dembitsky, Walter

2005-01-01

The REMATCH trial compared the use of left ventricular assist devices with optimal medical management for patients with end-stage heart failure. When the trial met its primary end point criteria in July 2001, left ventricular assist device therapy was shown to significantly improve survival and quality of life. With extended follow-up, 2 critical questions emerge: (1) Did these benefits persist, and (2) did outcomes improve over the course of the trial, given the evolving nature of the technology? We analyzed survival in this randomized trial by using the product-limit method of Kaplan and Meier. Changes in the benefits of therapy were analyzed by examining the effect of the enrollment period. The survival rates for patients receiving left ventricular assist devices (n = 68) versus patients receiving optimal medical management (n = 61) were 52% versus 28% at 1 year and 29% versus 13% at 2 years ( P = .008, log-rank test). As of July 2003, 11 patients were alive on left ventricular assist device support out of a total 16 survivors (including 3 patients receiving optimal medical management who crossed over to left ventricular assist device therapy). There was a significant improvement in survival for left ventricular assist device-supported patients who enrolled during the second half of the trial compared with the first half ( P = .03). The Minnesota Living with Heart Failure scores improved significantly over the course of the trial. The extended follow-up confirms the initial observation that left ventricular assist device therapy renders significant survival and quality-of-life benefits compared with optimal medical management for patients with end-stage heart failure. Furthermore, we observed an improvement in the survival of patients receiving left ventricular assist devices over the course of the trial, suggesting the effect of greater clinical experience.

Matrix Characterization and Development for the Vacuum Assisted Resin Transfer Molding Process

NASA Technical Reports Server (NTRS)

Grimsley, B. W.; Hubert, P.; Hou, T. H.; Cano, R. J.; Loos, A. C.; Pipes, R. B.

2001-01-01

The curing kinetics and viscosity of an epoxy resin system, SI-ZG-5A, have been characterized for application in the vacuum assisted resin transfer molding (VARTM) process. Impregnation of a typical carbon fiber perform provided the test bed for the characterization. Process simulations were carried out using the process model, COMPRO, to examine heat transfer and curing kinetics for a fully impregnated panel, neglecting resin flow. The predicted viscosity profile and final degree of cure were found to be in good agreement with experimental observations.

78 FR 34922 - Definition of Auditory Assistance Device

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... Report and Order will apply to small businesses that choose to use, manufacture, design, import, or sell... production and marketing, and introduce more competition for such devices. The Commission decided that this... assistance devices using industry standard components employing relatively straight-forward designs at a...

Efficacy of a novel procedure sheath and closure device during diagnostic catheterization: the multicenter randomized clinical trial of the FISH device.

PubMed

Bavry, Anthony A; Raymond, Russell E; Bhatt, Deepak L; Chambers, Charles E; DeNardo, Andrew J; Hermiller, James B; Myers, Paul R; Pitts, Douglas E; Scott, John A; Savader, Scott J; Steinhubl, Steven

2008-04-01

The aim of vascular closure devices is to safely secure the arterial access site at the conclusion of catheterization procedures, thereby increasing patient comfort and decreasing time to hemostasis and ambulation. The FISH (femoral introducer sheath and hemostasis) device is novel in that the access sheath and closure component are incorporated onto the same system. The FISH pivotal investigation was conducted at 8 catheterization laboratories throughout the United States. Eligible diagnostic patients were randomized (2 to 1) to the FISH device versus manual compression and assessed for time to hemostasis and time to ambulation. Half of the participants underwent ultrasonographic evaluation at 30-day follow up. Enrollment for an interventional cohort is ongoing and will be reported at a later date; however, the interventional patients enrolled to date were combined with the diagnostic patients to comprise the safety data of the trial. Overall, 191 patients were randomized to the FISH device and 106 patients to manual compression. Most patients received a 6 Fr sheath (approximately 70%), while the remaining patients received a 5 or 8 Fr sheath. Twenty-seven patients who received the FISH device were converted to manual compression due to anticipated suboptimal hemostasis. Among the diagnostic patients, the mean time to hemostasis was 8.9 minutes for the FISH device, compared to 17.2 minutes for manual compression (p < 0.0001). Similarly, the mean time to ambulation was 2.4 hours for the FISH device, compared to 4.3 hours for manual compression (p < 0.0001). Among the total cohort, there was 1 death and 1 episode of major access-site-related bleeding that required transfusion occurred in the FISH group (1.1%), compared to no serious adverse safety events in the manual compression group (p = 1.0). For the FISH group, there were 5 minor adverse safety events; 3 access-site hematomas and 2 pseudoaneurysms treated with thrombin injection, and in the manual compression

Transcranial Doppler quantification of residual shunt after percutaneous patent foramen ovale closure: correlation of device efficacy with intracardiac anatomic measures.

PubMed

Sorensen, Sherman G; Spruance, Spotswood L; Smout, Randall; Horn, Susan

2012-06-01

Percutaneous, mechanical closure of defects of the atrial septum fails to completely resolve shunting in up to 20% of cases. Little is known about the factors associated with device failure. We measured the left atrial opening (X), right atrial opening (Z), tunnel length (Y), septum secundum, device-septum primum separation, and tunnel compressibility of the patent foramen ovale (PFO) in 301 patients with cryptogenic neurological events, PFO anatomy, and severe Valsalva shunting (Spencer Grade 5-5+). All patients then underwent percutaneous closure with the GORE®HELEX Septal Occluder device and were evaluated at 3 months for residual shunt by transcranial Doppler (TCD). Severe residual Valsalva shunt (TCD Grade 5-5+) was found at 3 months in 21 of 301 (7%) patients. X, Y, and Z were associated with failure with a high degree of statistical significance, whereas the width of the septum secundum, device-septum primum separation, and tunnel compressibility were not. An unanticipated finding was that 14 of 35 (40%) patients sized with a large balloon failed compared with 9 of 280 (3%) sized with a small balloon (P < 0.0001). In the multivariate logistic regression model, X (P = < 0.0001) and balloon size (P < 0.0001) were both strong predictors of failure. In an intracardiac echocardiography-defined PFO population, characterized by severe baseline Valsalva shunt and a high incidence of persistent (rest) shunting, association of six intracardiac measurements to closure device failure by multivariate logistic regression showed that the width of the left atrial opening was a strong predictor of residual shunting. An unanticipated finding was that use of a large sizing balloon was also strongly associated with failure. ©2012, Wiley Periodicals, Inc.

Assessment of a simple, novel endoluminal method for gastrotomy closure in NOTES.

PubMed

Lee, Sang Soo; Oelschlager, Brant K; Wright, Andrew S; Soares, Renato V; Sinan, Huseyin; Montenovo, Martin I; Hwang, Joo Ha

2011-10-01

A reliable method for gastrotomy closure in NOTES will be essential for NOTES to become viable clinically. However, methods using existing and widely available endoscopic accessories have been ineffective. The objective of this study was to evaluate the feasibility and safety of a new simple method for gastric closure (retracted clip-assisted loop closure) that uses existing endoscopic accessories with minor modifications. The retracted clip-assisted loop closure technique involves deploying 3-4 Resolution(®) clips (modified by attaching a 90-cm length of suture to the end of each clip) along the margin of the gastrotomy with one jaw on the serosal surface and the other jaw on the mucosal surface. The suture strings are threaded through an endoloop. Traction is then applied to the strings causing the gastric wall to tent. The endoloop is secured below the tip of the clips, completing a full-thickness gastrotomy closure. The main outcome measures were feasibility, efficacy, and safety of the new retracted clip-assisted loop closure technique for NOTES gastrotomy closure. An air-tight seal was achieved in 100% (n = 9) of stomachs. The mean leak pressure was 116.3 (±19.4) mmHg. The retracted clip-assisted loop closure technique can be used to perform NOTES gastrotomy closure by using existing endoscopic accessories with minor modifications.

Payment for Assistive Devices by the Veterans Administration.

ERIC Educational Resources Information Center

Reeb, Kenneth G., Jr.; Stripling, Thomas E.

This report provides an overview of the Veterans Administration (VA) and how it pays for assistive devices for veterans. It explains the VA payment structure and decision-making responsibilities concerning assistive equipment. Following an introductory section, the report provides background on the VA system, summarizing its legislative origins,…

Solid state perovskite solar modules by vacuum-vapor assisted sequential deposition on Nd:YVO₄ laser patterned rutile TiO₂ nanorods.

PubMed

Fakharuddin, Azhar; Palma, Alessandro L; Di Giacomo, Francesco; Casaluci, Simone; Matteocci, Fabio; Wali, Qamar; Rauf, Muhammad; Di Carlo, Aldo; Brown, Thomas M; Jose, Rajan

2015-12-11

The past few years have witnessed remarkable progress in solution-processed methylammonium lead halide (CH3NH3PbX3, X = halide) perovskite solar cells (PSCs) with reported photoconversion efficiency (η) exceeding 20% in laboratory-scale devices and reaching up to 13% in their large area perovskite solar modules (PSMs). These devices mostly employ mesoporous TiO2 nanoparticles (NPs) as an electron transport layer (ETL) which provides a scaffold on which the perovskite semiconductor can grow. However, limitations exist which are due to trap-limited electron transport and non-complete pore filling. Herein, we have employed TiO2 nanorods (NRs), a material offering a two-fold higher electronic mobility and higher pore-filing compared to their particle analogues, as an ETL. A crucial issue in NRs' patterning over substrates is resolved by using precise Nd:YVO4 laser ablation, and a champion device with η ∼ 8.1% is reported via a simple and low cost vacuum-vapor assisted sequential processing (V-VASP) of a CH3NH3PbI3 film. Our experiments showed a successful demonstration of NRs-based PSMs via the V-VASP technique which can be applied to fabricate large area modules with a pin-hole free, smooth and dense perovskite layer which is required to build high efficiency devices.

Ultrasound-assisted extraction coupled with under vacuum distillation of flavour compounds from spearmint (carvone-rich) plants: Comparison with conventional hydrodistillation.

PubMed

Da Porto, Carla; Decorti, Deborha

2009-08-01

Ultrasonically assisted extraction of flavour compounds from different varieties of Mentha spicata, using 70% ethanol, have been carried out for 5, 10 and 15min and coupled with under vacuum distillation. The ultrasound distilled extracts have been analysed by GC-MS and compared with essential oils obtained by hydrodistillation. The results have showed that ultrasonically assisted extraction in combination with under vacuum distillation have provided extracts with higher flavouring strength due to the increased concentration of desirable oxygenated compounds (from 5 to 8 times) compared with hydrodistillation. Extraction yields of flavour volatiles have been calculated giving a range 0.04-0.13% by ultrasound and 0.01-0.02% by hydrodistillation.

Intra-operative device closure of perimembranous ventricular septal defect without cardiopulmonary bypass under guidance of trans-epicardial echocardiography: a single center experience.

PubMed

Sun, Yong; Zhu, Peng; Zhou, Pengyu; Guo, Yilong; Zheng, Shao-Yi

2016-05-27

Intraoperative device closure of perimembranous ventricular septal defect(VSD) through a lower mini-sternotomy is safe, less invasive, and has excellent surgical and cosmetic outcomes. Our study is to evaluate the feasibility of closing VSD under guidance of trans-epicardial echocardiography. We reviewed the clinical course of 41 patients referred to our institution for minimally invasive closure of perimembranous VSD. The trans-epicardial echocardiography(TEE) was used to monitor the whole procedure to guide the positioning of device and evaluate the operative effect instantly after operation. The procedure was successfully done in 38 patients(92.6 %) with mean age of 1.2 ± 1.5 years(range 0.5-6.1 years),mean weight of 10.78 ± 6.87 kg(range 5.2 ~ 26 kg) and VSD size of 5.1 ± 1.13 mm(range 5 ~ 10 mm). Three cases failed, including two cases whose guide-wires could not pass through VSDs and one case whose occluder could not repair VSD well. Three patients had tiny residual shunts because of the shifting of occluders. There were no major complications such as arrhythmia, valve regurgitation and the failure of occluder during follow-up(Mean 2.3 ± 1.2 years). TEE provided superior imaging of shapes and surrounding structures of the VSDs, and guide-wires passing through VSDs. Intraoperative device closure of perimembranous VSD through a lower mini-sternotomy without cardiopulmonary bypass appears to be a safe and effective procedure. The use of trans-epicardial echocardiography provides useful information for intraoperative device closure of VSD.

Personal digital assistant-based, internet-enabled remote communication system for a wearable pneumatic biventricular assist device.

PubMed

Nam, Kyoung Won; Lee, Jung Joo; Hwang, Chang Mo; Choi, Seong Wook; Son, Ho Sung; Sun, Kyung

2007-11-01

Currently, personal mobile communication devices have become quite common, and the applications of such devices have expanded quickly. Remote communication systems might be employed for the telemonitoring of patients or the operating status of their medical devices. In this article, we describe the development of a mobile-based artificial heart telemanagement system for use in a wearable extracorporeal pneumatic biventricular assist device, which is capable of telemonitoring and telecontrolling the operating status of the ventricular assist device from any site. The system developed herein utilized small mobile phones for the client device and adopted a standard transmission control protocol/Internet protocol communication protocol for the purposes of telecommunication. The results of in vitro and animal experiments showed that the telemanagement system developed herein operated in accordance with the desired parameters.

Angle closure glaucoma in congenital ectropion uvea.

PubMed

Wang, Grace M; Thuente, Daniel; Bohnsack, Brenda L

2018-06-01

Congenital ectropion uvea is a rare anomaly, which is associated with open, but dysplastic iridocorneal angles that cause childhood glaucoma. Herein, we present 3 cases of angle-closure glaucoma in children with congenital ectropion uvea. Three children were initially diagnosed with unilateral glaucoma secondary to congenital ectropion uvea at 7, 8 and 13 years of age. The three cases showed 360° of ectropion uvea and iris stromal atrophy in the affected eye. In one case, we have photographic documentation of progression to complete angle closure, which necessitated placement of a glaucoma drainage device 3 years after combined trabeculotomy and trabeculectomy. The 2 other cases, which presented as complete angle closure, also underwent glaucoma drainage device implantation. All three cases had early glaucoma drainage device encapsulation (within 4 months) and required additional surgery (cycloablation or trabeculectomy). Congenital ectropion uvea can be associated with angle-closure glaucoma, and placement of glaucoma drainage devices in all 3 of our cases showed early failure due to plate encapsulation. Glaucoma in congenital ectropion uvea requires attention to angle configuration and often requires multiple surgeries to obtain intraocular pressure control.

Assistive Device for Efficient Intravitreal Injections.

PubMed

Ullrich, Franziska; Michels, Stephan; Lehmann, Daniel; Pieters, Roel S; Becker, Matthias; Nelson, Bradley J

2016-08-01

Intravitreal therapy is the most common treatment for many chronic ophthalmic diseases, such as age-related macular degeneration. Due to the increasing worldwide demand for intravitreal injections, there exists a need to render this medical procedure more time- and cost-efficient while increasing patient safety. The authors propose a medical assistive device that injects medication intravitreally. Compared to the manual intravitreal injection procedure, an automated device has the potential to increase safety for patients, decrease procedure times, allow for integrated data storage and documentation, and reduce costs for medical staff and expensive operating rooms. This work demonstrates the development of an assistive injection system that is coarsely positioned over the patient's head by the human operator, followed by automatic fine positioning and intravitreal injection through the pars plana. Several safety features, such as continuous eye tracking and iris recognition, have been implemented. The functioning system is demonstrated through ex vivo experiments with porcine eyes. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:752-762.]. Copyright 2016, SLACK Incorporated.

Outcomes of Minimally Invasive Temporary Right Ventricular Assist Device Support for Acute Right Ventricular Failure During Minimally Invasive Left Ventricular Assist Device Implantation.

PubMed

Schaefer, Andreas; Reichart, Daniel; Bernhardt, Alexander M; Kubik, Mathias; Barten, Markus J; Wagner, Florian M; Reichenspurner, Hermann; Philipp, Sebastian A; Deuse, Tobias

Right ventricular failure (RVF) may still occur despite the benefits of minimally invasive left ventricular assist device (MI-LVAD) implantation. Our center strategy aims to avoid aggressive postoperative inotrope use by using mechanical support to facilitate right ventricle recovery and adaptation. We herein report first outcomes of patients with minimally invasive temporary right ventricular assist device (MI-t-RVAD) support for RVF during MI-LVAD implantation. Right ventricular failure was defined as requiring more than moderate inotopic support after weaning from cardiopulmonary bypass according to Interagency Registry for Mechanically Assisted Circulatory Support adverse event definitions. All patients requiring MI-t-RVAD support for RVF during MI-LVAD implantation between January, 2012 and April, 2016 were retrospectively reviewed. Clinical endpoints were death or unsuccessful RVAD weaning. Overall 10 patients (90% male, mean age 49.6 ± 14.8 years) underwent MI-t-RVAD implantation. Duration of MI-t-RVAD support was 16.2 ± 11.6 days. Right ventricular assist device weaning and subsequent uneventful awake device explantation was successful in all cases. The 30 day survival was 80%. Our results confirm safety and feasibility of MI-t-RVAD support for acute RVF in the setting of MI-LVAD implantation. The potential benefits of this strategy are more stable hemodynamics in the first postoperative days that usually are crucial for LVAD patients and reduced inotrope requirement.

Evaluation of venous distension device: potential aid for intravenous cannulation.

PubMed

Hedges, J R; Weinshenker, E; Dirksing, R

1986-05-01

A device designed to augment venous filling by applying a vacuum to the upper extremity during tourniquet application was evaluated. Ten healthy adult male volunteers with clinical normovolemia were studied for changes in forearm volume and dorsal hand vein turgor during use of an elastic tubing tourniquet, a blood pressure cuff tourniquet, and a vacuum-assisted cuff tourniquet. Use of the device for 30 seconds was not associated with petechia formation and resulted in a significant increase in venous turgor, as measured by an ophthalmologic tonometer, in comparison to the other tourniquet techniques (P less than .005). Use for 60 seconds was associated with mild to moderate subjective discomfort in all volunteers and petechiae in all nine white volunteers. All petechiae resolved in three days. Venous engorgement as reflected by volume displacement was significantly greater for the vacuum device and blood pressure cuff tourniquet combination than other techniques at 30 and 60 seconds of tourniquet application (P less than .005). Brief application of a vacuum to the arm during tourniquet use increases venous turgor and engorgement in normovolemic volunteers.

Implantable physiologic controller for left ventricular assist devices with telemetry capability.

PubMed

Asgari, Siavash S; Bonde, Pramod

2014-01-01

Rotary type left ventricular assist devices have mitigated the problem of durability associated with earlier pulsatile pumps and demonstrated improved survival. However, the compromise is the loss of pulsatility due to continuous flow and retained percutaneous driveline leading to increased mortality and morbidity. Lack of pulsatility is implicated in increased gastrointestinal bleeding, aortic incompetence, and diastolic hypertension. We present a novel, wirelessly powered, ultra-compact, implantable physiologic controller capable of running a left ventricular assist device in a pulsatile mode with wireless power delivery. The schematic of our system was laid out on a circuit board to wirelessly receive power and run a left ventricular assist device with required safety and backup measures. We have embedded an antenna and wireless network for telemetry. Multiple signal processing steps and controlling algorithm were incorporated. The controller was tested in in vitro and in vivo experiments. The controller drove left ventricular assist devices continuously for 2 weeks in an in vitro setup and in vivo without any failure. Our controller is more power efficient than the current Food and Drug Administration-approved left ventricular assist device controllers. When used with electrocardiography synchronization, the controller allowed on-demand customization of operation with instantaneous flow and revolutions per minute changes, resulting in a pulsatile flow with adjustable pulse pressure. Our test results prove the system to be remarkably safe, accurate, and efficient. The unique combination of wireless powering and small footprint makes this system an ideal totally implantable physiologic left ventricular assist device system. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Transcatheter closure of patent ductus arteriosus: past, present and future.

PubMed

Baruteau, Alban-Elouen; Hascoët, Sébastien; Baruteau, Julien; Boudjemline, Younes; Lambert, Virginie; Angel, Claude-Yves; Belli, Emre; Petit, Jérôme; Pass, Robert

2014-02-01

This review aims to describe the past history, present techniques and future directions in transcatheter treatment of patent ductus arteriosus (PDA). Transcatheter PDA closure is the standard of care in most cases and PDA closure is indicated in any patient with signs of left ventricular volume overload due to a ductus. In cases of left-to-right PDA with severe pulmonary arterial hypertension, closure may be performed under specific conditions. The management of clinically silent or very tiny PDAs remains highly controversial. Techniques have evolved and the transcatheter approach to PDA closure is now feasible and safe with current devices. Coils and the Amplatzer Duct Occluder are used most frequently for PDA closure worldwide, with a high occlusion rate and few complications. Transcatheter PDA closure in preterm or low-bodyweight infants remains a highly challenging procedure and further device and catheter design development is indicated before transcatheter closure is the treatment of choice in this delicate patient population. The evolution of transcatheter PDA closure from just 40 years ago with 18F sheaths to device delivery via a 3F sheath is remarkable and it is anticipated that further improvements will result in better safety and efficacy of transcatheter PDA closure techniques. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study.

PubMed

Lequin, Michiel B; Barth, Martin; Thomė, Claudius; Bouma, Gerrit J

2012-12-01

Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid® annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor. We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid® after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up. At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed. The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid® is currently underway, and will provide a higher level of evidence.

A field-emission based vacuum device for the generation of THz waves

NASA Astrophysics Data System (ADS)

Lin, Ming-Chieh

2005-03-01

Terahertz waves have been used to characterize the electronic, vibrational and compositional properties of solid, liquid and gas phase materials during the past decade. More and more applications in imaging science and technology call for the well development of THz wave sources. Amplification and generation of a high frequency electromagnetic wave are a common interest of field emission based devices. In the present work, we propose a vacuum electronic device based on field emission mechanism for the generation of THz waves. To verify our thinking and designs, the cold tests and the hot tests have been studied via the simulation tools, SUPERFISH and MAGIC. In the hot tests, two types of electron emission mechanisms are considered. One is the field emission and the other is the explosive emission. The preliminary design of the device is carried out and tested by the numerical simulations. The simulation results show that an electronic efficiency up to 4% can be achieved without employing any magnetic circuits.

Drying based on temperature-detection-assisted control in microwave-assisted pulse-spouted vacuum drying.

PubMed

Cao, Xiaohuang; Zhang, Min; Qian, He; Mujumdar, Arun S

2017-06-01

An online temperature-detection-assisted control system of microwave-assisted pulse-spouted vacuum drying was newly developed. By using this system, temperature control can be automatically and continuously adjusted based on the detection of drying temperature and preset temperature. Various strategies for constant temperature control, linear temperature control and three-step temperature control were applied to drying carrot cubes. Drying kinetics and the quality of various temperature-controlled strategies online are evaluated for the new drying technology as well as its suitability as an alternative drying method. Drying time in 70 °C mode 1 had the shortest drying time and lowest energy consumption in all modes. A suitable colour, highest re-hydration ratio and fracture-hardness, and longest drying time occurred in 30-40-50 °C mode 3. The number of hot spots was reduced in 40-50-60 °C mode 3. Acceptable carrot snacks were obtained in 50-60-70 °C mode 3 and 70 °C mode 2. All temperature curves showed that the actual temperatures followed the preset temperatures appropriately. With this system, a linear temperature-controlled strategy and a three-step temperature-controlled strategy can improve product quality and heating non-uniformity compared to constant temperature control, but need greater energy consumption and longer drying time. A temperature-detection-assisted control system was developed for providing various drying strategies as a suitable alternative in making a snack product. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

Pruning a decision tree for selecting computer-related assistive devices for people with disabilities.

PubMed

Chi, Chia-Fen; Tseng, Li-Kai; Jang, Yuh

2012-07-01

Many disabled individuals lack extensive knowledge about assistive technology, which could help them use computers. In 1997, Denis Anson developed a decision tree of 49 evaluative questions designed to evaluate the functional capabilities of the disabled user and choose an appropriate combination of assistive devices, from a selection of 26, that enable the individual to use a computer. In general, occupational therapists guide the disabled users through this process. They often have to go over repetitive questions in order to find an appropriate device. A disabled user may require an alphanumeric entry device, a pointing device, an output device, a performance enhancement device, or some combination of these. Therefore, the current research eliminates redundant questions and divides Anson's decision tree into multiple independent subtrees to meet the actual demand of computer users with disabilities. The modified decision tree was tested by six disabled users to prove it can determine a complete set of assistive devices with a smaller number of evaluative questions. The means to insert new categories of computer-related assistive devices was included to ensure the decision tree can be expanded and updated. The current decision tree can help the disabled users and assistive technology practitioners to find appropriate computer-related assistive devices that meet with clients' individual needs in an efficient manner.

Note: A simple sample transfer alignment for ultra-high vacuum systems.

PubMed

Tamtögl, A; Carter, E A; Ward, D J; Avidor, N; Kole, P R; Jardine, A P; Allison, W

2016-06-01

The alignment of ultra-high-vacuum sample transfer systems can be problematic when there is no direct line of sight to assist the user. We present the design of a simple and cheap system which greatly simplifies the alignment of sample transfer devices. Our method is based on the adaptation of a commercial digital camera which provides live views from within the vacuum chamber. The images of the camera are further processed using an image recognition and processing code which determines any misalignments and reports them to the user. Installation has proven to be extremely useful in order to align the sample with respect to the transfer mechanism. Furthermore, the alignment software can be easily adapted for other systems.

Use of cryopoor plasma for albumin replacement and continuous antimicrobial infusion for treatment of septic peritonitis in a dog.

PubMed

Ropski, Meaghan K; Guillaumin, Julien; Monnig, Andrea A; Townsend, Katy; McLoughlin, Mary A

2017-05-01

To report the successful management of a dog with septic peritonitis and septic shock secondary to enterectomy dehiscence using novel techniques for identification of intestinal dehiscence and for septic shock treatment. A 5-year-old castrated male Bernese Mountain Dog presented for lethargy 6 days following enterotomy for foreign body obstruction. Septic peritonitis was identified due to dehiscence of the enterotomy site, and resection and anastomosis were performed using a gastrointestinal anastomosis and thoracoabdominal stapling device. Postoperatively the patient experienced severe hypotension, which responded to norepinephrine constant rate infusion (CRI) after failing to improve with fluid therapy or dopamine CRI. Further treatment included antimicrobial CRI and supportive care including careful fluid therapy. Due to low effective circulating volume paired with intersititial fluid overload and large volume abdominal effusion, fluid therapy consisted of a combination of human serum albumin, canine albumin, synthetic colloids, and isotonic crystalloids. Cryopoor plasma (CPP) was used as a source of canine albumin and intravascular volume. On Day 4, food dye was given through a nasogastric tube due to suspicion of dehiscence of the anastomosis site. Dehiscence was confirmed during abdominal exploratory, and a second resection and anastomosis was performed. Abdominal partial closure with vacuum-assisted closure device was performed. Supportive care was continued with CPP CRI and imipenem CRI. Planned relaparotomy to change the vacuum-assisted closure device was performed 48 hours later, with abdominal closure 96 hours after anastomosis. The patient was discharged on Day 15. Recheck 12 months later was normal. This case includes novel techniques such food dye via nasogastric tube to identify anastomosis dehiscence, use of CPP as a source of canine albumin, and antimicrobial CRI in a dog with septic peritonitis. © Veterinary Emergency and Critical Care Society

Polyimide Composites Properties of RTM370 Fabricated by Vacuum Assisted Resins Transfer Molding (VARTM)

NASA Technical Reports Server (NTRS)

Chuang, Kathy C.; Criss, Jim M.; Mintz, Eric A.

2011-01-01

RTM370 imide resin based on 2,3,3 ,4 -biphenyl dianhydride ( a-BPDA), 3,4 -oxydianinline (3,4 -ODA) with 4-phenylethynylphthalic (PEPA) endcap has shown to exhibit high Tg (370 C) and low melt viscosity (10-30 poise) at 280 C with a pot-life of 1-2 h. Previously, RTM370 resin has been fabricated into composites with T650-35 carbon fabrics by resin transfer molding (RTM) successfully. RTM370 composites exhibit excellent mechanical properties up to 327 C (620 F), and outstanding property retention after aging at 288 C (550 F) for 1000 hrs. In this presentation, RTM 370 composites will be fabricated by vacuum assisted resins transfer molding (VARTM), using vacuum bags without mold. The mechanical properties of RTM370 composites fabricated by VARTM will be compared to those of RTM370 made by RTM.

Intracardiac echocardiography: use during transcatheter device closure of a patent ductus arteriosus in a dog.

PubMed

Chetboul, V; Damoiseaux, C; Behr, L; Morlet, A; Moise, N S; Gouni, V; Lavennes, M; Pouchelon, J-L; Laborde, F; Borenstein, N

2017-06-01

Intracardiac echocardiography (ICE) is used in humans for percutaneous interventional procedures, such as transcatheter device closures. Intracardiac echocardiography provides high-resolution imaging of cardiac structures with two-dimensional, M-mode, Doppler, and also three-dimensional modalities. The present report describes application of ICE during transcatheter occlusion of patent ductus arteriosus using a canine ductal occluder in a dog for which transesophageal echocardiography could not provide an optimal acoustic window. Copyright © 2017 Elsevier B.V. All rights reserved.

Devices useful for vacuum ultraviolet beam characterization including a movable stage with a transmission grating and image detector

DOEpatents

Gessner, Oliver; Kornilov, Oleg A; Wilcox, Russell B

2013-10-29

The invention provides for a device comprising an apparatus comprising (a) a transmission grating capable of diffracting a photon beam into a diffracted photon output, and (b) an image detector capable of detecting the diffracted photon output. The device is useful for measuring the spatial profile and diffraction pattern of a photon beam, such as a vacuum ultraviolet (VUV) beam.

Pan-nitinol occluder and special delivery device for closure of patent ductus arteriosus: a canine-model feasibility study.

PubMed

Jiang, Hai-bin; Bai, Yuan; Zong, Gang-jun; Han, Lin; Li, Wei-ping; Lu, Yang; Qin, Yong-wen; Zhao, Xian-xian

2013-01-01

The aim of this study was to evaluate a new type of occluder for patent ductus arteriosus. Patent ductus arteriosus was established in a canine model by anastomosing a length of autologous jugular vein to the descending aorta and the left pulmonary artery in an end-to-side fashion. Transcatheter closure of each patent ductus arteriosus was performed on 10 dogs, which were then monitored for as long as 6 months with aortography, echocardiography, and histologic evaluation. Transcatheter closure with use of the novel pan-nitinol device was successful in all canine models. Postoperative echocardiography showed that the location and shape of the occluders were normal, without any residual shunting. Further histologic evaluation confirmed that the occluder surface was completely endothelialized 3 months after implantation. Transcatheter patent ductus arteriosus closure with the pan-nitinol occluder can be performed safely and successfully in a canine model and shows good biological compatibility and low mortality rates.

Flow and Compaction During the Vacuum Assisted Resin Transfer Molding Process

NASA Technical Reports Server (NTRS)

Grimsley, Brian W.; Hubert, Pascal; Song, Xiao-Lan; Cano, Roberto J.; Loos, Alfred C.; Pipes, R. Byron

2001-01-01

The flow of an epoxy resin and compaction behavior of carbon fiber preform during vacuum- assisted resin transfer molding (VARTM) infiltration was measured using an instrumented tool. Composite panels were fabricated by the VARTM process using SAERTEX(R)2 multi-axial non- crimp carbon fiber fabric and the A.T.A.R.D. SI-ZG-5A epoxy resin. Resin pressure and preform thickness variation was measured during infiltration. The effects of the resin on the compaction behavior of the preform were measured. The local preform compaction during the infiltration is a combination of wetting and spring-back deformations. Flow front position computed by the 3DINFIL model was compared with the experimental data.

Percutaneous Repair of Postoperative Mitral Regurgitation After Left Ventricular Assist Device Implant.

PubMed

Cork, David P; Adamson, Robert; Gollapudi, Raghava; Dembitsky, Walter; Jaski, Brian

2018-02-01

Mitral regurgitation commonly improves after implantation of a left ventricular assist device without concomitant valvular repair owing to the mechanical unloading of the left ventricle. However, the development (or persistence) of significant mitral regurgitation after implantation of a left ventricular assist device is associated with adverse clinical events. We present a case of a left ventricular assist device patient who successfully underwent a percutaneous MitraClip procedure for repair of persistent late postoperative mitral insufficiency with demonstrable clinical and hemodynamic improvement. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Method of forming ultra thin film devices by vacuum arc vapor deposition

NASA Technical Reports Server (NTRS)

Schramm, Harry F. (Inventor)

2005-01-01

A method for providing an ultra thin electrical circuit integral with a portion of a surface of an object, including using a focal Vacuum Arc Vapor Deposition device having a chamber, a nozzle and a nozzle seal, depressing the nozzle seal against the portion of the object surface to create an airtight compartment in the chamber and depositing one or more ultra thin film layer(s) only on the portion of the surface of the object, the layers being of distinct patterns such that they form the circuit.

Obesity: An Independent Risk Factor for Insufficient Hemostasis Using the AngioSeal Vascular Closure Device After Antegrade Puncture

DOE Office of Scientific and Technical Information (OSTI.GOV)

Minko, Peter, E-mail: peterminko@yahoo.com; Katoh, Marcus; Graeber, Stefan

Purpose: This study was designed to investigate the efficacy of the AngioSeal vascular closure device after antegrade puncture of the femoral artery. Methods: In a prospective study, 120 consecutive patients underwent lower limb vascular intervention by an antegrade access to the common femoral artery (CFA). After intervention, a 6F (n = 88) or an 8F (n = 32) AngioSeal vascular closure device was used to achieve hemostasis. The technical success or the cause of failure was documented. In addition, the coagulation status (platelets, INR, prothrombin time, atrial thromboplastin time (PTT)), hypertonus, locoregional habitus of the groin, body mass index (BMI),more » presence of calcifications, and history of previous surgical interventions of the CFA were evaluated. Results: Hemostasis was achieved in 97 patients (81%). In 12 patients (10%), persistent bleeding of the puncture site required manual compression. In another nine patients (8%) a kink of the sheath obviated the passage of the collagen plug toward the vessel, and in two patients the anchor dislodged out of the vessel, requiring manual compression. There were no significant differences between the groups of successful and unsuccessful sealing regarding the mean platelets (241 vs. 254 * 10{sup 9}/l; P = 0.86), INR (1.06 vs. 1.02; P = 0.52), prothrombin time (90% vs. 90%; P = 0.86), and PTT (30 vs. 31 s; P = 0.82). However, unsuccessful sealing was more likely in obese patients with an increased BMI (26.6 vs. 28.8 kg/m{sup 2}; P = 0.04). Conclusions: Obesity seems to be an independent risk factor for insufficient sealing using the AngioSeal vascular closure device after antegrade puncture of the CFA. In 8% of our patients, hemostasis could not be achieved due to kink of the flexible sheath.« less

Feed-through connector couples RF power into vacuum chamber

NASA Technical Reports Server (NTRS)

Grandy, G. L.

1967-01-01

Feed-through device connects RF power to an RF coil in a vacuum chamber. The coil and leads are water cooled and vacuum tight seals are provided at the junctions. The device incorporates silver soldered copper tubes, polytetrafluoroethylene electrical insulators, and O-ring vacuum seals.

Development and assessment of a hand assist device: GRIPIT.

PubMed

Kim, Byungchul; In, Hyunki; Lee, Dae-Young; Cho, Kyu-Jin

2017-02-21

Although various hand assist devices have been commercialized for people with paralysis, they are somewhat limited in terms of tool fixation and device attachment method. Hand exoskeleton robots allow users to grasp a wider range of tools but are heavy, complicated, and bulky owing to the presence of numerous actuators and controllers. The GRIPIT hand assist device overcomes the limitations of both conventional devices and exoskeleton robots by providing improved tool fixation and device attachment in a lightweight and compact device. GRIPIT has been designed to assist tripod grasp for people with spinal cord injury because this grasp posture is frequently used in school and offices for such activities as writing and grasping small objects. The main development objective of GRIPIT is to assist users to grasp tools with their own hand using a lightweight, compact assistive device that is manually operated via a single wire. GRIPIT consists of only a glove, a wire, and a small structure that maintains tendon tension to permit a stable grasp. The tendon routing points are designed to apply force to the thumb, index finger, and middle finger to form a tripod grasp. A tension-maintenance structure sustains the grasp posture with appropriate tension. Following device development, four people with spinal cord injury were recruited to verify the writing performance of GRIPIT compared to the performance of a conventional penholder and handwriting. Writing was chosen as the assessment task because it requires a tripod grasp, which is one of the main performance objectives of GRIPIT. New assessment, which includes six different writing tasks, was devised to measure writing ability from various viewpoints including both qualitative and quantitative methods, while most conventional assessments include only qualitative methods or simple time measuring assessments. Appearance, portability, difficulty of wearing, difficulty of grasping the subject, writing sensation, fatigability

Assistive acting movement therapy devices with pneumatic rotary-type soft actuators.

PubMed

Wilkening, André; Baiden, David; Ivlev, Oleg

2012-12-01

Inherent compliance and assistive behavior are assumed to be essential properties for safe human-robot interaction. Rehabilitation robots demand the highest standards in this respect because the machine interacts directly with weak persons who are often sensitive to pain. Using novel soft fluidic actuators with rotary elastic chambers (REC actuators), compact, lightweight, and cost-effective therapeutic devices can be developed. This article describes modular design and control strategies for new assistive acting robotic devices for upper and lower extremities. Due to the inherent compliance and natural back-drivability of pneumatic REC actuators, these movement therapy devices provide gentle treatment, whereby the interaction forces between humans and the therapy device are estimated without the use of expensive force/torque sensors. An active model-based gravity compensation based on separated models of the robot and of the individual patient's extremity provides the basis for effective assistive control. The utilization of pneumatic actuators demands a special safety concept, which is merged with control algorithms to provide a sufficient level of safeness and to catch any possible system errors and/or emergency situations. A self-explanatory user interface allows for easy, intuitive handling. Prototypes are very comfortable for use due to several control routines that work in the background. Assistive devices have been tested extensively with several healthy persons; the knee/hip movement therapy device is now under clinical trials at the Clinic for Orthopaedics and Trauma Surgery at the Klinikum Stuttgart.

Composite Properties of RTM370 Polyimide Fabricated by Vacuum Assisted Resin Transfer Molding (VARTM)

NASA Technical Reports Server (NTRS)

Chuang, Kathy C.; Criss, James M.; Mintz, Eric A.; Shonkwiler, Brian; McCorkle, Linda S.

2011-01-01

RTM370 imide resin based on 2,3,3?,4?-biphenyl dianhydride (a-BPDA), 3,4'-oxydianinline (3,4'-ODA) with the 4-phenylethynylphthalic (PEPA) endcap has been shown to exhibit a high cured T(sub g) (370 C) and low melt viscosity (10-30 poise) at 280 C with a pot-life of 1-2 h. Previously, RTM370 resin has been successfully fabricated into composites reinforced with T650-35 carbon fabrics by resin transfer molding (RTM). RTM370 composites exhibit excellent mechanical properties up to 327?C (620?F), and outstanding property retention after aging at 288?C (550?F) for 1000 h. In this work, RTM370 composites were fabricated by vacuum assisted resin transfer molding (VARTM), using vacuum bags on a steel plate. The mechanical properties of RTM370 composites fabricated by VARTM are compared to those prepared by RTM.

Orthotopic heart transplant versus left ventricular assist device: A national comparison of cost and survival

PubMed Central

Mulloy, Daniel P.; Bhamidipati, Castigliano M.; Stone, Matthew L.; Ailawadi, Gorav; Kron, Irving L.; Kern, John A.

2012-01-01

Objectives Orthotopic heart transplantation is the standard of care for end-stage heart disease. Left ventricular assist device implantation offers an alternative treatment approach. Left ventricular assist device practice has changed dramatically since the 2008 Food and Drug Administration approval of the HeartMate II (Thoratec, Pleasanton, Calif), but at what societal cost? The present study examined the cost and efficacy of both treatments over time. Methods All patients who underwent either orthotopic heart transplantation (n = 9369) or placement of an implantable left ventricular assist device (n = 6414) from 2005 to 2009 in the Nationwide Inpatient Sample were selected. The trends in treatment use, mortality, and cost were analyzed. Results The incidence of orthotopic heart transplantation increased marginally within a 5-year period. In contrast, the annual left ventricular assist device implantation rates nearly tripled. In-hospital mortality from left ventricular assist device implantation decreased precipitously, from 42% to 17%. In-hospital mortality for orthotopic heart transplantation remained relatively stable (range, 3.8%–6.5%). The mean cost per patient increased for both orthotopic heart transplantation and left ventricular assist device placement (40% and 17%, respectively). With the observed increase in both device usage and cost per patient, the cumulative Left ventricular assist device cost increased 232% within 5 years (from $143 million to $479 million). By 2009, Medicare and Medicaid were the primary payers for nearly one half of all patients (orthotopic heart transplantation, 45%; left ventricular assist device, 51%). Conclusions Since Food and Drug Administration approval of the HeartMate II, mortality after left ventricular assist device implantation has decreased rapidly, yet has remained greater than that after orthotopic heart transplantation. The left ventricular assist device costs have continued to increase and have been

A proof-of-concept study of the VeinScrew: A new percutaneous venous closure device.

PubMed

Boersma, Doeke; de Borst, Gert Jan; Moll, Frans L

2017-02-01

Objective This study evaluated the concept of percutaneous closure of insufficient veins using the VeinScrew principle. Methods The VeinScrew is designed to place a spring-shaped implant that contracts and clamps around the vein. The ability of the device to occlude adequately was tested in a bench model experiment. The feasibility of accurate placement and adequate venous occlusion was evaluated in an animal experiment and in a human cadaveric experiment. Results The VeinScrew implant occluded up to a pressure of 135 mmHg. In vivo studies confirmed that deployment was challenging but technically feasible, and subsequent phlebography showed closure of the vein. The cadaveric study showed that percutaneous placement of the evolved VeinScrew around the great saphenous vein was feasible and accurate. Conclusions The current studies show the feasibility of the VeinScrew concept. Future developments and translational studies are necessary to determine the potential of this technique as a new option in the phlebologist's toolbox.

Comparison of Transplant Waitlist Outcomes for Pediatric Candidates Supported by Ventricular Assist Devices Versus Medical Therapy.

PubMed

Law, Sabrina P; Oron, Assaf P; Kemna, Mariska S; Albers, Erin L; McMullan, D Michael; Chen, Jonathan M; Law, Yuk M

2018-05-01

Ventricular assist devices have gained popularity in the management of refractory heart failure in children listed for heart transplantation. Our primary aim was to compare the composite endpoint of all-cause pretransplant mortality and loss of transplant eligibility in children who were treated with a ventricular assist device versus a medically managed cohort. This was a retrospective cohort analysis. Data were obtained from the Scientific Registry of Transplant Recipients. The at-risk population (n = 1,380) was less than 18 years old, either on a ventricular assist device (605 cases) or an equivalent-severity, intensively medically treated group (referred to as MED, 775 cases). None. The impact of ventricular assist devices was estimated via Cox proportional hazards regression (hazard ratio), dichotomizing 1-year outcomes to "poor" (22%: 193 deaths, 114 too sick) versus all others (940 successful transplants, 41 too healthy, 90 censored), while adjusting for conventional risk factors. Among children 0-12 months old, ventricular assist device was associated with a higher risk of poor outcomes (hazard ratio, 2.1; 95% CI, 1.5-3.0; p < 0.001). By contrast, ventricular assist device was associated with improved outcomes for ages 12-18 (hazard ratio, 0.3; 95% CI, 0.1-0.7; p = 0.003). For candidates 1-5 and 6-11 years old, there were no differences in outcomes between the ventricular assist device and MED groups (hazard ratio, 0.8 and 1.0, p = 0.43 and 0.9). The interaction between ventricular assist devices and age group was strongly significant (p < 0.001). This is a comparative study of ventricular assist devices versus medical therapy in children. Age is a significant modulator of waitlist outcomes for children with end-stage heart failure supported by ventricular assist device, with the impact of ventricular assist devices being more beneficial in adolescents.

Temporary abdominal closure with zipper-mesh device for management of intra-abdominal sepsis.

PubMed

Utiyama, Edivaldo Massazo; Pflug, Adriano Ribeiro Meyer; Damous, Sérgio Henrique Bastos; Rodrigues, Adilson Costa; Montero, Edna Frasson de Souza; Birolini, Claudio Augusto Vianna

2015-01-01

to present our experience with scheduled reoperations in 15 patients with intra-abdominal sepsis. we have applied a more effective technique consisting of temporary abdominal closure with a nylon mesh sheet containing a zipper. We performed reoperations in the operating room under general anesthesia at an average interval of 84 hours. The revision consisted of debridement of necrotic material and vigorous lavage of the involved peritoneal area. The mean age of patients was 38.7 years (range, 15 to 72 years); 11 patients were male, and four were female. forty percent of infections were due to necrotizing pancreatitis. Sixty percent were due to perforation of the intestinal viscus secondary to inflammation, vascular occlusion or trauma. We performed a total of 48 reoperations, an average of 3.2 surgeries per patient. The mesh-zipper device was left in place for an average of 13 days. An intestinal ostomy was present adjacent to the zipper in four patients and did not present a problem for patient management. Mortality was 26.6%. No fistulas resulted from this technique. When intra-abdominal disease was under control, the mesh-zipper device was removed, and the fascia was closed in all patients. In three patients, the wound was closed primarily, and in 12 it was allowed to close by secondary intent. Two patients developed hernia; one was incisional and one was in the drain incision. the planned reoperation for manual lavage and debridement of the abdomen through a nylon mesh-zipper combination was rapid, simple, and well-tolerated. It permitted effective management of severe septic peritonitis, easy wound care and primary closure of the abdominal wall.

[The evolution of vacuum extraction in obstetrics].

PubMed

Nikolov, A

2010-01-01

Vacuum extraction is one of the methods for assisted vaginal delivery. In this article the evolution of vacuum extraction in obstetrics is been discussed. Historical facts and data from the invention up to state-of-the-art vacuum systems in modern obstetrics are presented.

Homogenate-assisted Vacuum-powered Bubble Extraction of Moso Bamboo Flavonoids for On-line Scavenging Free Radical Capacity Analysis.

PubMed

Sun, Yinnan; Yang, Kui; Cao, Qin; Sun, Jinde; Xia, Yu; Wang, Yinhang; Li, Wei; Ma, Chunhui; Liu, Shouxin

2017-07-11

A homogenate-assisted vacuum-powered bubble extraction (HVBE) method using ethanol was applied for extraction of flavonoids from Phyllostachys pubescens (P. pubescens) leaves. The mechanisms of homogenate-assisted extraction and vacuum-powered bubble generation were discussed in detail. Furthermore, a method for the rapid determination of flavonoids by HPLC was established. HVBE followed by HPLC was successfully applied for the extraction and quantification of four flavonoids in P. pubescens , including orientin, isoorientin, vitexin, and isovitexin. This method provides a fast and effective means for the preparation and determination of plant active components. Moreover, the on-line antioxidant capacity, including scavenging positive ion and negative ion free radical capacity of different fractions from the bamboo flavonoid extract was evaluated. Results showed that the scavenging DPPH ˙ free radical capacity of vitexin and isovitexin was larger than that of isoorientin and orientin. On the contrary, the scavenging ABTS⁺ ˙ free radical capacity of isoorientin and orientin was larger than that of vitexin and isovitexin.

A Challenging Case of Patent Ductus Arteriosus Device Closure in an Adult with Unconventional Views and Catheters

PubMed Central

Garg, Naveen; Raja, Deep Chandh; Khanna, Roopali; Kumar, Sudeep

2018-01-01

Abnormally oriented patent ductus arteriosus is expected in adults, which can lead to difficulties while attempting a device closure. Alternate angiographic views like the “right anterior oblique view,” “retrograde approach” and in rare cases, as elicited in the following case scenario, special catheters like the “Tiger® catheter” can aid in crossing the lesion and completion of the procedure successfully. PMID:29876027

Use of an Amplatzer Device for Endoscopic Closure of a Large Bronchopleural Fistula following Lobectomy for a Stage I Squamous Cell Carcinoma.

PubMed

Ottevaere, A; Slabbynck, H; Vermeersch, P; Rogiers, P; Galdermans, D; De Droogh, E; Bedert, L

2013-01-01

Bronchopleural fistulas can occur as a rare but severe complication after pulmonary resection. Established guidelines for the proper treatment of patients with bronchopleural fistulas do not exist. Apart from attempts to close the fistula, emphasis is placed on preventive measures, early treatment with antibiotics, drainage of the empyema and aggressive nutritional and rehabilitative support. For inoperable patients, endoscopic procedures are the only therapeutic option. Unfortunately, large (>8 mm) or central bronchopleural fistulas are usually not suitable for such endoscopic management. Recently, some groups have published a few case reports about a novel technique for the endobronchial closure of bronchopleural fistulas, using an Amplatzer device, originally designed for transcatheter closure of cardiac septal defects. We applied the same technique as a life-saving treatment in a ventilated patient who was considered inoperable due to a high oxygen need. The operation was successful. The patient could be weaned from ventilation and was eventually discharged from the hospital to a rehabilitation facility several weeks after the insertion of the device. Until now, endoscopic techniques have only been useful for the treatment of small, peripheral, bronchopleural fistulas and even then only as a bridge to surgery in high-risk surgical patients. In this case report, we demonstrate that the use of an Amplatzer device can expand the importance of endoscopic techniques in the treatment of bronchopleural fistulas. An Amplatzer device, for endobronchial closure, can indeed be administered for large and central bronchopleural fistulas. Moreover, it can be considered as a definite alternative to surgery in inoperable patients.

Resection of giant right atrial lymphoma using vacuum-assisted cardiopulmonary bypass without snaring the inferior vena cava.

PubMed

Shin, Hankei; Mori, Mitsuharu; Matayoshi, Toru; Suzuki, Ryo; Yozu, Ryohei

2004-08-01

A 53-year-old man sustained hemodynamic collapse due to a huge right atrial tumor and was transferred to our hospital and underwent a life-saving emergency operation. The tumor arose from the inferolateral wall of the right atrium, occupying almost the whole right atrial cavity and obstructing not only the inflow of the right ventricle but also the orifice of the inferior vena cava. Venous cannulation via the right atrial wall and placing a snare around the inferior vena cava were impossible. With a cardiopulmonary bypass using vacuum-assisted venous drainage, the tumor was successfully resected and the tricuspid valve was replaced with a bioprosthetic valve without snaring the inferior vena cava. Postoperative histological examination demonstrated the tumor to be a large B-cell non-Hodgkin type malignant lymphoma. When the tumor is large and it is difficult to establish total cardiopulmonary bypass, the vacuum-assisted cardiopulmonary bypass is a useful option. This can achieve a bloodless operative field and is not blocked by the incoming air, due to the venous drainage being continually pressure-regulated.

21 CFR 884.4340 - Fetal vacuum extractor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control. (b) Classification...

21 CFR 884.4340 - Fetal vacuum extractor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control. (b) Classification...

Preclinical assessment of a modified Occlutech left atrial appendage closure device in a canine model.

PubMed

Kim, Jung-Sun; Lee, Seul-Gee; Bong, Sung-Kyung; Park, Se-Il; Hong, Sung-Yu; Shin, Sanghoon; Shim, Chi Young; Hong, Geu-Ru; Choi, Donghoon; Jang, Yangsoo; Park, Jai-Wun

2016-10-15

LAA occlusion has a similar stroke prevention efficacy compared to anticoagulation treatment for non-valvular atrial fibrillation. The objective of this study was to assess the feasibility and safety of a modified Occlutech® left atrial appendage (LAA) closure device in a canine model. The device was implanted in 10 dogs (33±1kg) using fluoroscopy and transesophageal echocardiography (TEE) guidance. The modified Occlutech® LAA occlusion device was compared with the current version, the Watchman device, and the Amplazter cardiac plug (ACP). LAA occlusion and anchoring to the LAA were evaluated. All dogs were assessed using angiography, TEE, and a gross anatomy examination. The 10 LAA occlusion devices were to be implanted into 10 dogs (5 modified Occlutech devices, 3 current version of Occlutech devices, 1 Watchman, and 1 ACP). LAA implantation was not performed in one dog due to transeptal puncture failure. The three current version of Occlutech devices were embolized immediately after implantation, so three modified devices of the same size were implanted securely without embolization. The mean implant size was 20.1±2.0mm. The devices chosen were a mean of 23.3±10.6% larger than the measured landing zone diameters. Post-implant angiography and TEE revealed well-positioned devices without pericardial effusion or impingement on surrounding structures. The results of this acute animal study suggested that a modified Occlutech® LAA occlusion device was feasible and had greater anchoring performance in canines. Additional large clinical studies are needed to evaluate safety and efficacy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Simulating ideal assistive devices to reduce the metabolic cost of walking with heavy loads.

PubMed

Dembia, Christopher L; Silder, Amy; Uchida, Thomas K; Hicks, Jennifer L; Delp, Scott L

2017-01-01

Wearable robotic devices can restore and enhance mobility. There is growing interest in designing devices that reduce the metabolic cost of walking; however, designers lack guidelines for which joints to assist and when to provide the assistance. To help address this problem, we used musculoskeletal simulation to predict how hypothetical devices affect muscle activity and metabolic cost when walking with heavy loads. We explored 7 massless devices, each providing unrestricted torque at one degree of freedom in one direction (hip abduction, hip flexion, hip extension, knee flexion, knee extension, ankle plantarflexion, or ankle dorsiflexion). We used the Computed Muscle Control algorithm in OpenSim to find device torque profiles that minimized the sum of squared muscle activations while tracking measured kinematics of loaded walking without assistance. We then examined the metabolic savings provided by each device, the corresponding device torque profiles, and the resulting changes in muscle activity. We found that the hip flexion, knee flexion, and hip abduction devices provided greater metabolic savings than the ankle plantarflexion device. The hip abduction device had the greatest ratio of metabolic savings to peak instantaneous positive device power, suggesting that frontal-plane hip assistance may be an efficient way to reduce metabolic cost. Overall, the device torque profiles generally differed from the corresponding net joint moment generated by muscles without assistance, and occasionally exceeded the net joint moment to reduce muscle activity at other degrees of freedom. Many devices affected the activity of muscles elsewhere in the limb; for example, the hip flexion device affected muscles that span the ankle joint. Our results may help experimentalists decide which joint motions to target when building devices and can provide intuition for how devices may interact with the musculoskeletal system. The simulations are freely available online, allowing

Simulating ideal assistive devices to reduce the metabolic cost of walking with heavy loads

PubMed Central

Silder, Amy; Uchida, Thomas K.; Hicks, Jennifer L.; Delp, Scott L.

2017-01-01

Wearable robotic devices can restore and enhance mobility. There is growing interest in designing devices that reduce the metabolic cost of walking; however, designers lack guidelines for which joints to assist and when to provide the assistance. To help address this problem, we used musculoskeletal simulation to predict how hypothetical devices affect muscle activity and metabolic cost when walking with heavy loads. We explored 7 massless devices, each providing unrestricted torque at one degree of freedom in one direction (hip abduction, hip flexion, hip extension, knee flexion, knee extension, ankle plantarflexion, or ankle dorsiflexion). We used the Computed Muscle Control algorithm in OpenSim to find device torque profiles that minimized the sum of squared muscle activations while tracking measured kinematics of loaded walking without assistance. We then examined the metabolic savings provided by each device, the corresponding device torque profiles, and the resulting changes in muscle activity. We found that the hip flexion, knee flexion, and hip abduction devices provided greater metabolic savings than the ankle plantarflexion device. The hip abduction device had the greatest ratio of metabolic savings to peak instantaneous positive device power, suggesting that frontal-plane hip assistance may be an efficient way to reduce metabolic cost. Overall, the device torque profiles generally differed from the corresponding net joint moment generated by muscles without assistance, and occasionally exceeded the net joint moment to reduce muscle activity at other degrees of freedom. Many devices affected the activity of muscles elsewhere in the limb; for example, the hip flexion device affected muscles that span the ankle joint. Our results may help experimentalists decide which joint motions to target when building devices and can provide intuition for how devices may interact with the musculoskeletal system. The simulations are freely available online, allowing

Mycobacterium chimaera left ventricular assist device infections.

PubMed

Balsam, Leora B; Louie, Eddie; Hill, Fred; Levine, Jamie; Phillips, Michael S

2017-06-01

A global outbreak of invasive Mycobacterium chimaera infections after cardiac surgery has recently been linked to bioaerosols from contaminated heater-cooler units. The majority of cases have occurred after valvular surgery or aortic graft surgery and nearly half have resulted in death. To date, infections in patients with left ventricular assist devices (LVADs) have not been characterized in the literature. We report two cases of device-associated M. chimaera infection in patients with continuous-flow LVADs and describe challenges related to diagnosis and management in this population. © 2017 Wiley Periodicals, Inc.

Environmentally-assisted technique for transferring devices onto non-conventional substrates

DOEpatents

Lee, Chi-Hwan; Kim, Dong Rip; Zheng, Xiaolin

2016-05-10

A device fabrication method includes: (1) providing a growth substrate including an oxide layer; (2) forming a metal layer over the oxide layer; (3) forming a stack of device layers over the metal layer; (4) performing fluid-assisted interfacial debonding of the metal layer to separate the stack of device layers and the metal layer from the growth substrate; and (5) affixing the stack of device layers to a target substrate.

Operations manual for the patient assist device. [to handle electrical appliances

NASA Technical Reports Server (NTRS)

Schrader, M. A.

1973-01-01

Quadriplegic patients and multiple amputee patients are almost totally dependent on nursing personnel for any activities or interests in which they participate. A patient assist device is reported which provides patient control over electrical devices in his environment. The patient operates three switches to acquire control over a desired electrical appliance. The type switches employed are chosen to conform to patient capabilities, even when such capabilities are as limited as eye or head movements. The switch operations are sensed and converted into command signals by the patient assist device to control ten electrical appliances simulataneously and independently.

A self-aligning knee joint for walking assistance devices.

PubMed

Byungjune Choi; Younbaek Lee; Jeonghun Kim; Minhyung Lee; Jongwon Lee; Se-Gon Roh; Hyundo Choi; Yong-Jae Kim; Jung-Yun Choi

2016-08-01

This paper presents a novel self-aligning knee mechanism for walking assistance devices for the elderly to provide physical gait assistance. Self-aligning knee joints can assist in flexion/extension motions of the knee joint and compensate the knee's transitional movements in the sagittal plane. In order to compensate the center of rotation, which moves with the flexion/extension motion of the human knee joint, a self-aligning knee joint is proposed that adds redundant degrees of freedom (i.e., 2-DoF) to the 1-DoF revolute joint. The key idea of the proposed mechanism is to decouple joint rotations and translations for use in lower-extremity wearable devices. This paper describes the mechanical design of this self-aligning knee mechanism and its implementation on a wearable robot and in preliminary experiments. The performance of the proposed mechanism is verified by simulations and experiments.

Cost savings associated with prevention of recurrent lumbar disc herniation with a novel annular closure device: a multicenter prospective cohort study.

PubMed

Parker, Scott L; Grahovac, Gordan; Vukas, Duje; Ledic, Darko; Vilendecic, Milorad; McGirt, Matthew J

2013-09-01

Same-level recurrent disc herniation is a well-defined complication following lumbar discectomy. Reherniation results in increased morbidity and health care costs. Techniques to reduce these consequences may improve outcomes and reduce cost after lumbar discectomy. In a prospective cohort study, we set out to evaluate the cost associated with surgical management of recurrent, same-level lumbar disc herniation following primary discectomy. Forty-six consecutive European patients undergoing lumbar discectomy for a single-level herniated disc at two institutions were prospectively followed with clinical and radiographic evaluations. A second consecutive cohort of 30 patients undergoing 31 lumbar discectomies with implantation of an annular closure device was followed at the same hospitals and same follow-up intervals. Cost estimates for reherniation were modeled on Medicare national allowable payment amounts (direct cost) and patient work-day losses (indirect cost). Annular closure and control cohorts were matched at baseline. By 2 years follow-up, symptomatic recurrent same-level disc herniation occurred in three (6.5%) patients in the control cohort versus zero (0%) patients in the annular closure cohort. For patients experiencing recurrent disc herniation, mean estimated direct and indirect cost of management of recurrent disc herniation was $34,242 and $3,778, respectively. Use of an annular closure device potentially results in a cost savings of $222,573 per 100 primary discectomy procedures performed (or $2,226 per discectomy), based solely on the reduction of reoperated reherniations when modeled on U.S. Medicare costs. Recurrent disc herniation did not occur in any patients after annular closure within the 12-month follow-up. The reduction in the incidence of reherniation was associated with potentially significant cost savings. Development of novel techniques to prevent recurrent lumbar disc herniation is warranted to decrease the associated morbidity and

AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure.

PubMed

Trabattoni, Daniela; Gaspardone, Achille; Sgueglia, Gregory A; Fabbiocchi, Franco; Gioffrè, Gaetano; Montorsi, Piero; Calligaris, Giuseppe; Iamele, Maria; De Santis, Antonella; Bartorelli, Antonio L

2017-04-20

The aim of this observational study was to compare acute and 12-month results of percutaneous closure of patent foramen ovale (PFO) with two occluder devices. Between June 2007 and October 2014, 406 consecutive patients (48.1±13.3 years, 243 women) underwent percutaneous PFO closure with either the AMPLATZER (n=179) or the Figulla (n=227) device after a stroke or a transient ischaemic attack ascribed to the PFO. A right-to-left shunt grade >1 was previously detected in all patients and atrial septal aneurysm was present in 111 (27.5%) patients. Patients were followed up with a contrast transthoracic echocardiogram and clinically at 24 hours, six months, and 12 months after the procedure. A high procedural success was observed in both groups. Despite a trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 right-to-left shunt was observed in 4.5% of patients, independently of the device used for PFO closure. The only difference reported after Figulla device implantation was a lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02). According to this two-centre study, PFO closure appears safe and effective with the Figulla occluder as well as with the AMPLATZER device.

Carbon nanotube vacuum gauges utilizing long, dissipative tubes

NASA Astrophysics Data System (ADS)

Kaul, Anupama B.; Manohara, Harish M.

2008-04-01

A carbon nanotube-based thermal conductivity vacuum gauge is described which utilizes 5-10 μm long diffusively contacted SWNTs for vacuum sensing. By etching the thermal SiO II beneath the tubes and minimizing heat conduction through the substrate, pressure sensitivity was extended toward higher vacuums. The pressure response of unannealed and annealed devices was compared to that of released devices. The released devices showed sensitivity to pressure as low as 1 x 10 -6 Torr. The sensitivity increased more dramatically with power for the released device compared to that of the unreleased device. Low temperature electronic transport measurements of the tubes were suggestive of a thermally activated hopping mechanism where the activation energy for hopping was calculated to be ~ 39 meV.

Surgical energy device using steam jet for robotic assisted surgery.

PubMed

Yoshiki, Hitoshi; Tadano, Kotaro; Ban, Daisuke; Ohuchi, Katsuhiro; Tanabe, Minoru; Kawashima, Kenji

2015-01-01

In robotic assisted surgery, the carbonization and the adherence of coagulated tissues caused by surgical energy devices are problems. We propose a surgical energy device using a steam jet to solve the problems. The device applies a steam jet and performs coagulation and hemostasis. The exposed tissue is heated quickly with latent heat of the steam. The carbonization and the adherence of the tissue can be avoided. We prototyped a steam jet coagulator to prove the concept. The coagulator was mounted on the laparoscopic surgical robot. The effectiveness of the coagulation and hemostasis using steam was confirmed by the in vitro experiment on the chicken's liver and the in vivo experiments on the pig's spleen under the robotic assisted laparoscopic environment.

Effect of HeartMate left ventricular assist device on cardiac autonomic nervous activity.

PubMed

Kim, S Y; Montoya, A; Zbilut, J P; Mawulawde, K; Sullivan, H J; Lonchyna, V A; Terrell, M R; Pifarré, R

1996-02-01

Clinical performance of a left ventricular assist device is assessed via hemodynamic parameters and end-organ function. This study examined effect of a left ventricular assist device on human neurophysiology. This study evaluated the time course change of cardiac autonomic activity of 3 patients during support with a left ventricular assist device before cardiac transplantation. Cardiac autonomic activity was determined by power spectral analysis of short-term heart rate variability. The heart rate variability before cardiac transplantation was compared with that on the day before left ventricular assist device implantation. The standard deviation of the mean of the R-R intervals of the electrocardiogram, an index of vagal activity, increased to 27 +/- 7 ms from 8 +/- 0.6 ms. The modulus of power spectral components increased. Low frequency (sympathetic activity) and high frequency power (vagal activity) increased by a mean of 9 and 22 times of each baseline value (low frequency power, 5.2 +/- 3.0 ms2; high frequency power, 2.1 +/- 0.7 ms2). The low over high frequency power ratio decreased substantially, indicating an improvement of cardiac sympatho-vagal balance. The study results suggest that left ventricular assist device support before cardiac transplantation may exert a favorable effect on cardiac autonomic control in patients with severe heart failure.

Assistive Devices for People with Hearing, Voice, Speech, or Language Disorders

MedlinePlus

... sleepy. What research is being conducted on assistive technology? The National Institute on Deafness and Other Communication ... NIDCD) funds research into several areas of assistive technology, such as those described below. Improved devices for ...

14 CFR 382.131 - Do baggage liability limits apply to mobility aids and other assistive devices?

Code of Federal Regulations, 2014 CFR

2014-01-01

... mobility aids and other assistive devices? 382.131 Section 382.131 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Stowage of Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.131 Do baggage liability limits apply to mobility aids and other assistive devices? With...

14 CFR 382.131 - Do baggage liability limits apply to mobility aids and other assistive devices?

Code of Federal Regulations, 2013 CFR

2013-01-01

... mobility aids and other assistive devices? 382.131 Section 382.131 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Stowage of Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.131 Do baggage liability limits apply to mobility aids and other assistive devices? With...

14 CFR 382.131 - Do baggage liability limits apply to mobility aids and other assistive devices?

Code of Federal Regulations, 2012 CFR

2012-01-01

... mobility aids and other assistive devices? 382.131 Section 382.131 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Stowage of Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.131 Do baggage liability limits apply to mobility aids and other assistive devices? With...

[Importance of mechanical assist devices in acute circulatory arrest].

PubMed

Ferrari, Markus Wolfgang

2016-03-01

Mechanical assist devices are indicated for hemodynamic stabilization in acute circulatory arrest if conventional means of cardiopulmonary resuscitation are unable to re-establish adequate organ perfusion. Their temporary use facilitates further diagnostic and therapeutic options in selected patients, e.g. coronary angiography followed by revascularization.External thorax compression devices allow sufficient cardiac massage in case of preclinical or in-hospital circulatory arrest, especially under complex transfer conditions. These devices perform standardized thorax compressions at a rate of 80-100 per minute. Invasive mechanical support devices are used in the catheter laboratory or in the intensive care unit. Axial turbine pumps, e.g. the Impella, continuously pump blood from the left ventricle into the aortic root. The Impella can also provide right ventricle support by pumping blood from the vena cava into the pulmonary artery. So-called emergency systems or ECMO devices consist of a centrifugal pump and a membrane oxygenator allowing complete takeover of cardiac and pulmonary functions. Withdrawing blood from the right atrium and vena cava, oxygenated blood is returned to the abdominal aorta. Isolated centrifugal pumps provide left heart support without an oxygenator after transseptal insertion of a venous cannula into the left atrium.Mechanical assist devices are indicated for acute organ protection and hemodynamic stabilization for diagnostic and therapeutic measures as well as bridge to myocardial recovery. Future technical developments and better insights into the pathophysiology of mechanical circulatory support will broaden the spectrum of indications of such devices in acute circulatory arrest.

Endoscopic Vacuum-Assisted Closure Therapy in Patients with Anastomotic Leakage after Esophagectomy: A Single-Center Experience

PubMed Central

Noh, Soo Min; Lee, Jeong Hoon; Jung, Hwoon-Yong; AlGhamdi, Zeead; Kim, Hyeong Ryul; Kim, Yong-Hee

2018-01-01

Aim To study the efficacy of E-VAC therapy for patients with anastomotic leakage after esophagectomy. Methods Between January 2013 and April 2017, 12 patients underwent E-VAC therapy for the management of postoperative leakage. Their clinical features and endoscopic procedure details, therapy results, adverse events, and survival were investigated. Results All 12 patients were male and the median age was 57 years (interquartile range 51.5–62.8 years). The reasons for esophageal surgery were esophageal cancer (83.3%), gastrointestinal stromal tumor (8.3%), and esophageal diverticulum (8.3%). Prior to E-VAC therapy, 6 patients had undergone failed primary surgical repair and the median duration from esophagectomy to leakage discovery was 13.5 days (IQR 6–207 days). The median duration of E-VAC therapy was 25 days (IQR 13.5–34.8 days) and the average sponge exchange rate was 2.7 times during the treatment period. After E-VAC therapy, 8 patients (66.7%) had complete leakage closure, 3 (25%) had a decreased leakage size, and 1 (8.3%) was unchanged. The three patients with a decreased leakage size after E-VAC therapy were treated with endoscopic and conservative management without further surgery. Conclusion With proper patient selection, E-VAC therapy is a feasible and safe method for the treatment of anastomotic leakage after esophagectomy. PMID:29849581

An effective vacuum assisted extraction method for the optimization of labdane diterpenoids from Andrographis paniculata by response surface methodology.

PubMed

Wang, Ya-Qi; Wu, Zhen-Feng; Ke, Gang; Yang, Ming

2014-12-31

An effective vacuum assisted extraction (VAE) technique was proposed for the first time and applied to extract bioactive components from Andrographis paniculata. The process was carefully optimized by response surface methodology (RSM). Under the optimized experimental conditions, the best results were obtained using a boiling temperature of 65 °C, 50% ethanol concentration, 16 min of extraction time, one extraction cycles and a 12:1 liquid-solid ratio. Compared with conventional ultrasonic assisted extraction and heat reflux extraction, the VAE technique gave shorter extraction times and remarkable higher extraction efficiency, which indicated that a certain degree of vacuum gave the solvent a better penetration of the solvent into the pores and between the matrix particles, and enhanced the process of mass transfer. The present results demonstrated that VAE is an efficient, simple and fast method for extracting bioactive components from A. paniculata, which shows great potential for becoming an alternative technique for industrial scale-up applications.

Vacuum-Assisted Low-Temperature Synthesis of Reduced Graphene Oxide Thin-Film Electrodes for High-Performance Transparent and Flexible All-Solid-State Supercapacitors.

PubMed

Aytug, Tolga; Rager, Matthew S; Higgins, Wesley; Brown, Forrest G; Veith, Gabriel M; Rouleau, Christopher M; Wang, Hui; Hood, Zachary D; Mahurin, Shannon M; Mayes, Richard T; Joshi, Pooran C; Kuruganti, Teja

2018-04-04

Simple and easily integrated design of flexible and transparent electrode materials affixed to polymer-based substrates hold great promise to have a revolutionary impact on the functionality and performance of energy storage devices for many future consumer electronics. Among these applications are touch sensors, roll-up displays, photovoltaic cells, health monitors, wireless sensors, and wearable communication devices. Here, we report an environmentally friendly, simple, and versatile approach to produce optically transparent and mechanically flexible all-solid-state supercapacitor devices. These supercapacitors were constructed on tin-doped indium oxide coated polyethylene terephthalate substrates by intercalation of a polymer-based gel electrolyte between two reduced graphene oxide (rGO) thin-film electrodes. The rGO electrodes were fabricated simply by drop-casting of graphene oxide (GO) films, followed by a novel low-temperature (≤250 °C) vacuum-assisted annealing approach for the in situ reduction of GO to rGO. A trade-off between the optical transparency and electrochemical performance is determined by the concentration of the GO in the initial dispersion, whereby the highest capacitance (∼650 μF cm -2 ) occurs at a relatively lower optical transmittance (24%). Notably, the all-solid-state supercapacitors demonstrated excellent mechanical flexibility with a capacity retention rate above 90% under various bending angles and cycles. These attributes underscore the potential of the present approach to provide a path toward the realization of thin-film-based supercapacitors as flexible and transparent energy storage devices for a variety of practical applications.

An annulus fibrosus closure device based on a biodegradable shape-memory polymer network.

PubMed

Sharifi, Shahriar; van Kooten, Theo G; Kranenburg, Hendrik-Jan C; Meij, Björn P; Behl, Marc; Lendlein, Andreas; Grijpma, Dirk W

2013-11-01

Injuries to the intervertebral disc caused by degeneration or trauma often lead to tearing of the annulus fibrosus (AF) and extrusion of the nucleus pulposus (NP). This can compress nerves and cause lower back pain. In this study, the characteristics of poly(D,L-lactide-co-trimethylene carbonate) networks with shape-memory properties have been evaluated in order to prepare biodegradable AF closure devices that can be implanted minimally invasively. Four different macromers with (D,L-lactide) to trimethylene carbonate (DLLA:TMC) molar ratios of 80:20, 70:30, 60:40 and 40:60 with terminal methacrylate groups and molecular weights of approximately 30 kg mol(-1) were used to prepare the networks by photo-crosslinking. The mechanical properties of the samples and their shape-memory properties were determined at temperatures of 0 °C and 40 °C by tensile tests- and cyclic, thermo-mechanical measurements. At 40 °C all networks showed rubber-like behavior and were flexible with elastic modulus values of 1.7-2.5 MPa, which is in the range of the modulus values of human annulus fibrosus tissue. The shape-memory characteristics of the networks were excellent with values of the shape-fixity and the shape-recovery ratio higher than 98 and 95%, respectively. The switching temperatures were between 10 and 39 °C. In vitro culture and qualitative immunocytochemistry of human annulus fibrosus cells on shape-memory films with DLLA:TMC molar ratios of 60:40 showed very good ability of the networks to support the adhesion and growth of human AF cells. When the polymer network films were coated by adsorption of fibronectin, cell attachment, cell spreading, and extracellular matrix production was further improved. Annulus fibrosus closure devices were prepared from these AF cell-compatible materials by photo-polymerizing the reactive precursors in a mold. Insertion of the multifunctional implant in the disc of a cadaveric canine spine showed that these shape-memory devices could be

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2012-07-01 2012-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2014-07-01 2014-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2011-07-01 2011-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2013-07-01 2013-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

Assistive device use and mobility-related factors among adults aged≥65years.

PubMed

West, Bethany A; Bhat, Geeta; Stevens, Judy; Bergen, Gwen

2015-12-01

Examining how assistive device (cane, walker) use relates to other mobility factors can provide insight into older adults' future mobility needs. Data come from the Second Injury Control and Risk Survey, Phase 2 (ICARIS2-P2), conducted from March 2007 to May 2008. Prevalence estimates were calculated for older adults (aged ≥65) and multivariable logistic regression was used to explore associations between assistive device use and mobility-related characteristics. Compared with non-users, assistive device users were more likely to report a recent fall (AOR 12.0; 95% CI 4.9-29.3), limit walking outside due to concerns about falling (AOR 7.1; 95% CI 2.6-19.1), be unable to walk outside for 10min without resting (AOR 3.3; 95% CI 1.1-9.3), and be no longer driving (AOR 6.7; 95% CI 2.0-22.3). Assistive device users have limited mobility and an increased risk for fall injury compared with non-users. Effective fall prevention interventions, and innovative transportation options, are needed to protect the mobility of this high-risk group. Published by Elsevier Ltd.

Transcatheter closure of ventricular septal defect with Occlutech Duct Occluder.

PubMed

Atik-Ugan, Sezen; Saltik, Irfan Levent

2018-04-01

Patent ductus arteriosus occluders are used for transcatheter closure of ventricular septal defects, as well as for closure of patent ductus arteriosus. The Occlutech Duct Occluder is a newly introduced device for transcatheter closure of patent ductus arteriosus. Here, we present a case in which the Occlutech Duct Occluder was successfully used on a patient for the closure of a perimembraneous ventricular septal defect.

21 CFR 880.6740 - Vacuum-powered body fluid suction apparatus.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vacuum-powered body fluid suction apparatus. 880... Personal Use Miscellaneous Devices § 880.6740 Vacuum-powered body fluid suction apparatus. (a) Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample...

21 CFR 880.6740 - Vacuum-powered body fluid suction apparatus.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vacuum-powered body fluid suction apparatus. 880... Personal Use Miscellaneous Devices § 880.6740 Vacuum-powered body fluid suction apparatus. (a) Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample...

Safety of Percutaneous Patent Ductus Arteriosus Closure: An Unselected Multicenter Population Experience

PubMed Central

El‐Said, Howaida G.; Bratincsak, Andras; Foerster, Susan R.; Murphy, Joshua J.; Vincent, Julie; Holzer, Ralf; Porras, Diego; Moore, John; Bergersen, Lisa

2013-01-01

Background The technique and safety of transcatheter patent ductus arteriosus (PDA) closure have evolved during the past 20 years. We sought to report a multicenter experience of PDA closure with a focus on the rate of adverse events (AE) and a review of institutional practice differences. Methods and Results Outcome data on transcatheter PDA closure were collected at 8 centers prospectively using a multicenter registry (Congenital Cardiac Catheterization Project on Outcome Registry). Between February 2007 and June 2010, 496 PDA closures were recorded using a device in 338 (68%) or coils in 158 (32%). Most patients had an isolated PDA (90%). Fifty percent of patients were between 6 months and 3 years old, with only 40 patients (8%) <6 months old. Median minimum PDA diameter was 2.5 mm (range 1 to 12 mm; IQR 2 to 3 mm) for device closure and 1 mm (range 0.5 to 6 mm; IQR 1 to 2 mm) for coil closure (P<0.001). A device rather than coil was used in patients <3 years, weight <11 kg, and with a PDA minimum diameter >2 mm (all P<0.001). Three of 8 centers exclusively used a device for PDAs with a diameter >1.5 mm. In 9% of cases (n=46), an AE occurred; however, only 11 (2%) were classified as high severity. Younger age was associated with a higher AE rate. Coil‐related AEs were more common than device‐related AEs (10% versus 2%, P<0.001). Conclusions PDA closure in the present era has a very low rate of complications, although these are higher in younger children. Technical intervention‐related events were more common in coil procedures compared with device procedures. For PDAs ≤2.5 mm in diameter, institutional differences in preference for device versus coil exist. PMID:24284214

Atrial septal defect closure with the new Cardia Ultrasept II™ device with interposed Goretex patch: Mexican experience - has the perforation of Ivalon's membrane been solved?

PubMed

Mijangos-Vázquez, Roberto; García-Montes, Antonio J; Soto-López, Elena M; Guarner-Lans, Verónica; Zabal, Carlos

2018-05-01

The objective of this study was to demonstrate the safety and feasibility of using the new Cardia Ultrasept II™ device with interposed Goretex patch referring to the perforation of polyvinyl alcohol membrane. Great advances have been made in the development of devices for closure of atrial septal defect. The Cardia Ultrasept II™ with interposed Goretex patch is the modified last generation of Cardia devices, having the advantage of a super-low profile within the atria and an integral locking delivery-retrieval mechanism that ensures safe deployment. In addition, with the interposition of the Goretex, it has been possible to abolish perforation of Ivalon's membrane as a complication.Methods and resultsPatients with ostium secundum atrial septal defect with surrounding rims with a minimum length of 5 mm and who underwent atrial septal defect closure with the new Ultrasept II™ with Goretex patch were included from two paediatric cardiac centres. Primary end point was to determine perforation of the Goretex membrane at follow-up; secondary end point included right ventricular diastolic diameter. In total, 30 patients underwent atrial septal defect closure at a median age of 6 (1-29) years. At follow-up for 6 (range, 1-15) months, freedom from perforations was 100%. A continuous decrease in right ventricular diastolic diameter was found with an initial median of 30 (25-49) mm and after catheterisation of 27.5 (18-33) mm, p=0.01, and Z-score of 2.6 (1.7-3.6) versus 1.9 (1-2.9) after procedure, p=0.01. The new modified generation of the Ultrasept II™ device with interposed Goretex patch is a good alternative to achieve atrial septal defect closure safely and feasibly with no membrane perforation at follow-up.

Advanced patient transfer assist device with intuitive interaction control.

PubMed

Humphreys, Heather C; Choi, Young Mi; Book, Wayne J

2017-10-24

This research aims to improve patient transfers by developing a new type of advanced robotic assist device. It has multiple actuated degrees of freedom and a powered steerable base to maximize maneuverability around obstacles. An intuitive interface and control strategy allows the caregiver to simply push on the machine in the direction of desired patient motion. The control integrates measurements of both force and proximity to mitigate any potential large collision forces and provides operators information about obstacles with a form of haptic feedback. Electro-hydraulic pump controlled actuation provides high force density for the actuation. Nineteen participants performed tests to compare transfer operations (transferring a 250-lb mannequin between a wheelchair, chair, bed, and floor) and interaction control of a prototype device with a commercially available patient lift. The testing included a time study of the transfer operations and subjective rating of device performance. The results show that operators perform transfer tasks significantly faster and rate performance higher using the prototype patient transfer assist device than with a current market patient lift. With further development, features of the new patient lift can help facilitate patient transfers that are safer, easier, and more efficient for caregivers.

Percutaneous closure of patent ductus arteriosus in children using amplatzer duct occluder II: relationship between PDA type and risk of device protrusion into the descending aorta.

PubMed

Masri, Samer; El Rassi, Issam; Arabi, Mariam; Tabbakh, Anas; Bitar, Fadi

2015-08-01

To compare the efficacy and safety of Amplatzer Duct Occluder II (ADOII) among the various patent ductus arteriosus (PDA) types, and to assess the association between development of aortic obstruction and the PDA type in terms of measurable parameters as the device angulation and distance of upper end protrusion into the aortic lumen. Retrospective cohort study involving 50 consecutive subjects who underwent ADO II device closure of PDA. The median age and weight at intervention were 13 months (5.5 months to 18 years) and 11 (6-67) kg respectively. The median smallest ductal diameter by angiography was 3.2 (1.9-5.4) mm. Thirty two patients had type A PDA, 5 had type C, 5 had type D, and 8 had type E. Residual shunt was seen in only 1 patient who had a tubular PDA and resolved within 2 months of the procedure. No device embolization or pulmonary side protrusion were noted. There was a 16% aortic protrusion rate. The median distance of protrusion of the upper end of the device into the aortic lumen was 3.1 (0-9) mm and the median angle formed between the aortic end of the device and the PDA take-off was 10.4 (0-80.6) degrees. These latter parameters of aortic obstruction were significantly higher in the non-conical PDA group as compared to the conical PDA. Nevertheless, there was no significant coarctation due to aortic retention disc protrusion. Device closure of PDA using the ADO II is a safe procedure for chosen types of PDA. We demonstrated a novel technique for objective assessment of device protrusion into the descending aorta based on measurable parameters. ADOII device closure of non-conical PDAs warrants closer follow ups. © 2015 Wiley Periodicals, Inc.

Contemporary outcomes of percutaneous closure of patent ductus arteriosus in adolescents and adults.

PubMed

P, Sudhakar; Jose, John; George, Oommen K

Catheter based treatment has gained wide acceptance for management of patent ductus arteriosus (PDA) ever since its introduction. Percutaneous closure in adults can be challenging because of anatomical factors including large sizes, associated pulmonary arterial hypertension (PAH) and co-morbidities. This study aimed to provide comprehensive contemporary data on the safety and efficacy of percutaneous device closure of PDA in adult and adolescent population at a large referral center. This single-center retrospective analysis included 70 patients (33 adolescents and 37 adults) who underwent successful percutaneous device closure of PDA between January 2011 and February 2017.Baseline patient demographics, clinical characteristics, procedural and device related variables, and immediate outcomes during hospital stay were recorded. Patients were followed up for residual shunt and complications. Of 70 PDA device closure cases, 71.4% were females; the mean age was 23 years (range:10-58years). Devices used were 4-Cook's detachable coils, 64-occluders (ADO-I and II, Lifetech, Cardi-O-Fix), 1-vascular plug and 1-ventricular septal occluder device. Device success was achieved in all including those with very large PDAs. At 24-h post-procedure, the success rate of transcatheter intervention was 95.7%. At 6-months follow up, complete closure was observed in all (mean follow up duration-531days). In patients with severe PAH, significant immediate and sustained reduction of the mean pulmonary pressure was observed(77mmHg to 33mmHg;P=0.014). No procedure-related complications including death, device embolization and stenosis of aorta or pulmonary artery occurred. In contemporary practice, percutaneous device closure is an effective and safe treatment option for adolescent and adult PDA patients. Copyright © 2017. Published by Elsevier B.V.

In-vacuum exposure shutter

DOEpatents

Johnson, Terry A.; Replogle, William C.; Bernardez, Luis J.

2004-06-01

An in-vacuum radiation exposure shutter device can be employed to regulate a large footprint light beam. The shutter device includes (a) a source of radiation that generates an energy beam; (2) a shutter that includes (i) a frame defining an aperture toward which the energy beam is directed and (ii) a plurality of blades that are secured to the frame; and (3) device that rotates the shutter to cause the plurality of blades to intercept or allow the energy beam to travel through the aperture. Each blade can have a substantially planar surface and the plurality of blades are secured to the frame such that the planar surfaces of the plurality of blades are substantially parallel to each other. The shutter device is particularly suited for operation in a vacuum environment and can achieve shuttering speeds from about 0.1 second to 0.001 second or faster.

Studies to determine the effectiveness of automated flagger assistance devices and school crossing devices.

DOT National Transportation Integrated Search

2012-01-01

This report describes the methodology and results of analyses performed to determine motorist understanding, as well as : the operational and safety effectiveness, of automated flagger assistance devices (AFADs) relative to the use of flaggers at lan...

Percutaneous Ventricular Assist Devices: A Health Technology Assessment.

PubMed

2017-01-01

Percutaneous coronary intervention (PCI)-using a catheter to place a stent to keep blood vessels open-is increasingly used for high-risk patients who cannot undergo surgery. Cardiogenic shock (when the heart suddenly cannot pump enough blood) is associated with a high mortality rate. The percutaneous ventricular assist device can help control blood pressure and increase blood flow in these high-risk conditions. This health technology assessment examined the benefits, harms, and budget impact of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock. We also analyzed cost-effectiveness of the Impella device in high-risk PCI. We performed a systematic search of the literature for studies examining the effects of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on hemodynamic stability, mortality, major adverse cardiac events, bleeding, and vascular complications. We developed a Markov decision-analytical model to assess the cost- effectiveness of Impella devices versus intra-aortic balloon pumps (IABPs), calculated incremental cost-effectiveness ratios (ICERs) using a 10-year time horizon, and conducted sensitivity analyses to examine the robustness of the estimates. The economic model was conducted from the perspective of the Ontario Ministry of Health and Long-Term Care. Eighteen studies (one randomized controlled trial and 10 observational studies for high-risk PCI, and one randomized controlled trial and six observational studies for cardiogenic shock) were included in the clinical review. Compared with IABPs, Impella 2.5, one model of the device, improved hemodynamic parameters (GRADE low-very low) but showed no significant difference in mortality (GRADE low), major adverse cardiac events (GRADE low), bleeding (GRADE low), or vascular

Percutaneous Ventricular Assist Devices: A Health Technology Assessment

PubMed Central

Lee, Christine; Djalalov, Sandjar; Xie, Xuanqian; Holubowich, Corinne

2017-01-01

Background Percutaneous coronary intervention (PCI)—using a catheter to place a stent to keep blood vessels open—is increasingly used for high-risk patients who cannot undergo surgery. Cardiogenic shock (when the heart suddenly cannot pump enough blood) is associated with a high mortality rate. The percutaneous ventricular assist device can help control blood pressure and increase blood flow in these high-risk conditions. This health technology assessment examined the benefits, harms, and budget impact of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock. We also analyzed cost-effectiveness of the Impella device in high-risk PCI. Methods We performed a systematic search of the literature for studies examining the effects of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on hemodynamic stability, mortality, major adverse cardiac events, bleeding, and vascular complications. We developed a Markov decision-analytical model to assess the cost- effectiveness of Impella devices versus intra-aortic balloon pumps (IABPs), calculated incremental cost-effectiveness ratios (ICERs) using a 10-year time horizon, and conducted sensitivity analyses to examine the robustness of the estimates. The economic model was conducted from the perspective of the Ontario Ministry of Health and Long-Term Care. Results Eighteen studies (one randomized controlled trial and 10 observational studies for high-risk PCI, and one randomized controlled trial and six observational studies for cardiogenic shock) were included in the clinical review. Compared with IABPs, Impella 2.5, one model of the device, improved hemodynamic parameters (GRADE low–very low) but showed no significant difference in mortality (GRADE low), major adverse cardiac events (GRADE low

Vacuum decay container closure integrity leak test method development and validation for a lyophilized product-package system.

PubMed

Patel, Jayshree; Mulhall, Brian; Wolf, Heinz; Klohr, Steven; Guazzo, Dana Morton

2011-01-01

A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated for container-closure integrity verification of a lyophilized product in a parenteral vial package system. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity check, and for testing product stored on stability in lieu of sterility tests. Method development and optimization challenge studies incorporated artificially defective packages representing a range of glass vial wall and sealing surface defects, as well as various elastomeric stopper defects. Method validation required 3 days of random-order replicate testing of a test sample population of negative-control, no-defect packages and positive-control, with-defect packages. Positive-control packages were prepared using vials each with a single hole laser-drilled through the glass vial wall. Hole creation and hole size certification was performed by Lenox Laser. Validation study results successfully demonstrated the vacuum decay leak test method's ability to accurately and reliably detect those packages with laser-drilled holes greater than or equal to approximately 5 μm in nominal diameter. All development and validation studies were performed at Whitehouse Analytical Laboratories in Whitehouse, NJ, under the direction of consultant Dana Guazzo of RxPax, LLC, using a VeriPac 455 Micro Leak Test System by Packaging Technologies & Inspection (Tuckahoe, NY). Bristol Myers Squibb (New Brunswick, NJ) fully subsidized all work. A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated to detect defects in stoppered vial packages containing lyophilized product for injection. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity

A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation

PubMed Central

2012-01-01

Background Wire closure still remains the preferred technique despite reasonable disadvantages. Associated complications, such as infection and sternal instability, cause time- and cost-consuming therapies. We present a new tool for sternal closure with its first clinical experience and results. Methods The sternal ZipFixTM System is based on the cable-tie principle. It primarily consists of biocompatible Poly-Ether-Ether-Ketone implants and is predominantly used peristernally through the intercostal space. The system provides a large implant-to-bone contact for better force distribution and for avoiding bone cut through. Results 50 patients were closed with the ZipFixTM system. No sternal instability was observed at 30 days. Two patients developed a mediastinitis that necessitated the removal of the device; however, the ZipFixTM were intact and the sternum remained stable. Conclusions In our initial evaluation, the short-term results have shown that the sternal ZipFixTM can be used safely and effectively. It is fast, easy to use and serves as a potential alternative for traditional wire closure. PMID:22731778

Integrated Cooling-Vacuum-Assisted Non-Fractional 1540 nm Erbium:Glass Laser is Effective in Treating Acne Scars.

PubMed

Politi, Yael; Levi, Assi; Lapidoth, Moshe

2016-11-01

Acne scars are a common result of in ammatory acne, affecting many patients worldwide. Among which, atrophic scars are the most prevalent form, presenting as dermal depressions caused by inflammatory degeneration of dermal collagen. Mid-infrared laser skin interaction is characterized by its modest absorption in water and nite penetration to the mid-dermis. Since collagen is a desirable laser target, 1540-nm wavelength is amenable for collagen remodeling within the depressed area of atrophic scars. To evaluate the safety and efficacy of acne scars treatment using an integrated cooling-vacuum-assisted 1540 nm Erbium: Glass Laser. This interventional prospective study included 25 volunteers (10 men, 15 women) with post acne atrophic scars. Patients were treated with a mid-infrared non-fractional 1540 nm Er:Glass laser (Alma Lasers Ltd. Caesarea, Israel) with integrat- ed cooling- vacuum assisted technology. Acne scars were exposed to 3 stacked laser pulses (400-600 mJ/pulse, 4 mm spot size, frequency of 3 Hz). Patients underwent 3-6 treatment sessions with a 2-3 week interval and were followed-up 1 month and 3 months after the last treatment. Clinical photographs were taken by high resolution digital camera before and after treatment. Clinical evaluation was performed by two independent dermatologists and results were graded on a scale of 0 (exacerbation) to 4 (76%-100% improvement). Patients' and physicians' satisfaction were also recorded (on a 1-5 scale). Pain perception and adverse effects were evaluated as well. Almost all patients (24/25) demonstrated a moderate to significant improvement. Average improvement was 3.9 and 4.1 points on the quartile scale used for outcome assessment 1 and 3 months following the last session, respectively. Patient satisfaction rate was 4.2. Side effects were minimal and transient: erythema, mild transient vesicles, and mild pain or inconvenience. CONCLUSION Cooling-Vacuum-Assisted mid-infrared non-fractional Er:Glass 1540 nm laser

What Are Some Types of Assistive Devices and How Are They Used?

MedlinePlus

... in persons with hearing problems. Cognitive assistance, including computer or electrical assistive devices, can help people function following brain injury. Computer software and hardware, such as voice recognition programs, ...

Vacuum-integrated electrospray deposition for highly reliable polymer thin film.

PubMed

Park, Soohyung; Lee, Younjoo; Yi, Yeonjin

2012-10-01

Vacuum electrospray deposition (ESD) equipment was designed to prepare polymer thin films. The polymer solution can be injected directly into vacuum system through multi-stage pumping line, so that the solvent residues and ambient contaminants are highly reduced. To test the performance of ESD system, we fabricated organic photovoltaic cells (OPVCs) by injecting polymer solution directly onto the substrate inside a high vacuum chamber. The OPVC fabricated has the structure of Al∕P3HT:PCBM∕PEDOT:PSS∕ITO and was optimized by varying the speed of solution injection and concentration of the solution. The power conversion efficiency (PCE) of the optimized OPVC is 3.14% under AM 1.5G irradiation without any buffer layer at the cathode side. To test the advantages of the vacuum ESD, we exposed the device to atmosphere between the deposition steps of the active layer and cathode. This showed that the PCE of the vacuum processed device is 24% higher than that of the air exposed device and confirms the advantages of the vacuum prepared polymer film for high performance devices.

Animal trials of a Magnetically Levitated Left-Ventricular Assist Device

NASA Technical Reports Server (NTRS)

Paden, Brad; Antaki, James; Groom, Nelson

2000-01-01

The University of Pittsburgh/Magnetic Moments mag-lev left-ventricular assist devices (LVADs), the Streamliner HG3b and HG3c, have successfully been implanted in calves. The first was implanted for 4 hours on July 10, 1998 and the second for 34 days on August 24, 1999 respectively. The tests confirmed the feasibility of low power levitation (1.5 watts coil power) and very low blood damage in a mag-lev ventricular assist device. In this paper, we describe the unique geometry of this pump and its design. Key features of this LVAD concept are the passive radial suspension and active voice-coil thrust bearing.

Histology after lumpectomy in women with epithelial atypia on stereotactic vacuum-assisted breast biopsy.

PubMed

Graesslin, O; Antoine, M; Chopier, J; Seror, J Y; Flahault, A; Callard, P; Daraï, E; Uzan, S

2010-02-01

Large-core needle biopsy of the breast (LCNB) and vacuum-assisted breast biopsy (VABB) are widely used as alternatives to open surgical biopsy (OSB) for initial diagnosis of mammographic abnormalities. Between 18% and 80% of cases in which such specimens show atypical lobular hyperplasia (ALH) or atypical ductal hyperplasia (ADH) are found to be malignant at surgery. From 1999 to 2005, 68 women with mammographic abnormalities were sampled by stereotactic VABB and presented atypical epithelial hyperplasia. Immunohistochemical staining with anti-cytokeratin 5/6 and anti-E-cadherin antibodies was performed. All women underwent a lumpectomy. Clinical, radiological or histological factors predictive of the risk of finding malignancy at surgery were sought. VABB initially showed 28 cases of ADH, 32 cases of ALH, one case of flat epithelial atypia, five cases of mixed atypia, and two cases of Lobular Carcinoma In Situ (LCIS). After slide review with immunohistochemical staining, two cases of ADH were reclassified as simple hyperplasia and two cases of ALH were reclassified as mixed atypia. Seven lesions (10.3%) that appeared to be benign on VABB were found to be malignant on OSB (Ductal Carcinoma In Situ (DCIS) in six cases and invasive ductal carcinoma in one case). ADH was the only predictive factor of malignancy on OSB (p=0.04 versus ALH). ADH diagnosed by vacuum-assisted breast biopsy frequently corresponds to cancer on open surgical biopsy. Surgical excision of all breast lesions containing atypical hyperplasia on percutaneous biopsy can be recommended. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

Bridge to Removal: A Paradigm Shift for Left Ventricular Assist Device Therapy

PubMed Central

Selzman, Craig H.; Madden, Jesse L.; Healy, Aaron H.; McKellar, Stephen H.; Koliopoulou, Antigone; Stehlik, Josef; Drakos, Stavros G.

2014-01-01

Ventricular assist devices have become standard therapy for patients with advanced heart failure either as a bridge to transplantation or destination therapy. Despite the functional and biologic evidence of reverse cardiac remodeling, few patients actually proceed to myocardial recovery, and even fewer to the point of having their device explanted. An enhanced understanding of the biology and care of the mechanically supported patient has redirected focus on the possibility of using ventricular assist devices as a bridge to myocardial recovery and removal. Herein, we review the current issues and approaches to transforming myocardial recovery to a practical reality. PMID:25442985

Development and evaluation of a new taxonomy of mobility-related assistive technology devices.

PubMed

Shoemaker, Laura L; Lenker, James A; Fuhrer, Marcus J; Jutai, Jeffrey W; Demers, Louise; DeRuyter, Frank

2010-10-01

This article reports on the development of a new taxonomy for mobility-related assistive technology devices. A prototype taxonomy was created based on the extant literature. Five mobility device experts were engaged in a modified Delphi process to evaluate and refine the taxonomy. Multiple iterations of expert feedback and revision yielded consensual agreement on the structure and terminology of a new mobility device taxonomy. The taxonomy uses a hierarchical framework to classify ambulation aids and wheeled mobility devices, including their key features that impact mobility. Five attributes of the new taxonomy differentiate it from previous mobility-related device classifications: (1) hierarchical structure, (2) primary device categories are grouped based on their intended mobility impact, (3) comprehensive inclusion of technical features, (4) a capacity to assimilate reimbursement codes, and (5) availability of a detailed glossary. The taxonomy is intended to support assistive technology outcomes research. The taxonomy will enable researchers to capture mobility-related assistive technology device interventions with precision and provide a common terminology that will allow comparisons among studies. The prominence of technical features within the new taxonomy will hopefully promote research that helps clinicians predict how devices will perform, thus aiding clinical decision making and supporting funding recommendations.

Nursing care of the ambulatory patient with a mechanical assist device.

PubMed

Reedy, J E; Ruzevich, S A; Noedel, N R; Vitale, L J; Merkle, E J

1990-01-01

Since 1986, 10 men and one woman were ambulatory while supported with mechanical assist devices as a bridge to heart transplantation. Four patients received a subclavian intraaortic balloon pump, two were supported with a Novacor left ventricular assist system, three patients received Pierce-Donachy ventricular assist devices, and one patient received a Jarvik 7 total artificial heart. One patient with an intraaortic balloon pump later received a left ventricular assist system because of hemodynamic deterioration despite the intraaortic balloon pump. Before device insertion all 11 patients were in cardiogenic shock despite inotropic and vasodilator support. The time of support ranged from 8 to 440 days (median, 24 days). In-house coverage by the circulatory support team was necessary only during the first 24 to 72 hours of support. When the patient's condition was stabilized, nursing staff monitored the devices with "on-call" availability of the circulatory support team. After implant of the device, all patients were able to perform activities of daily living. Once patients were able to walk in their hospital rooms, ambulation began in the hallways; frequency and distance were gradually increased. Four of the patients walked outside the hospital while tethered to the drive console. Daily physical therapy contributed to increased exercise tolerance. Protective isolation was used before and after transplantation to minimize the risk of infection. Sterile dressing changes (gown, gloves, mask) were applied to drive lines, cannula sites, and incisions. All invasive lines and catheters were removed as soon as the patient's clinical condition warranted, and noninvasive monitoring was used to decrease the chance of infection.(ABSTRACT TRUNCATED AT 250 WORDS)

Magnet Assisted Composite Manufacturing: A Flexible New Technique for Achieving High Consolidation Pressure in Vacuum Bag/Lay-Up Processes.

PubMed

Pishvar, Maya; Amirkhosravi, Mehrad; Altan, M Cengiz

2018-05-17

This work demonstrates a protocol to improve the quality of composite laminates fabricated by wet lay-up vacuum bag processes using the recently developed magnet assisted composite manufacturing (MACM) technique. In this technique, permanent magnets are utilized to apply a sufficiently high consolidation pressure during the curing stage. To enhance the intensity of the magnetic field, and thus, to increase the magnetic compaction pressure, the magnets are placed on a magnetic top plate. First, the entire procedure of preparing the composite lay-up on a magnetic bottom steel plate using the conventional wet lay-up vacuum bag process is described. Second, placement of a set of Neodymium-Iron-Boron permanent magnets, arranged in alternating polarity, on the vacuum bag is illustrated. Next, the experimental procedures to measure the magnetic compaction pressure and volume fractions of the composite constituents are presented. Finally, methods used to characterize microstructure and mechanical properties of composite laminates are discussed in detail. The results prove the effectiveness of the MACM method in improving the quality of wet lay-up vacuum bag laminates. This method does not require large capital investment for tooling or equipment and can also be used to consolidate geometrically complex composite parts by placing the magnets on a matching top mold positioned on the vacuum bag.

The Impact of Turtle Excluder Devices and Fisheries Closures on Loggerhead and Kemp's Ridley Strandings in the Western Gulf of Mexico

USGS Publications Warehouse

Lewison, R.L.; Crowder, L.B.; Shaver, D.J.

2003-01-01

The Sea Turtle Stranding and Salvage Network has been monitoring turtle strandings for more than 20 years in the United States. High numbers of strandings in the early to mid-1980s prompted regulations to require turtle excluder devices (TEDs) on shrimping vessels (trawlers). Following year-round TED implementation in 1991, however, stranding levels in the Gulf of Mexico increased. We evaluated the efficacy of TEDs and other management actions (e.g., fisheries closures) on loggerhead (Caretta caretta) and Kemp's ridley (Lepidochelys kempii) turtle populations by analyzing a long-term, stranding data set from the western Gulf of Mexico. Our analyses suggest that both sea turtle population growth and shrimping activity have contributed to the observed increase in strandings. Compliance with regulations requiring turtle excluder devices was a significant factor in accounting for annual stranding variability: low compliance was correlated with high levels of strandings. Our projections suggest that improved compliance with TED regulations will reduce strandings to levels that, in conjunction with other protective measures, should promote population recoveries for loggerhead and Kemp's ridley turtles. Local, seasonal fisheries closures, concurrent with TED enforcement, could reduce strandings to even lower levels. A seasonal closure adjacent to a recently established Kemp's ridley nesting beach may also reduce mortality of nesting adults and thus promote long-term population persistence by fostering the establishment of a robust secondary nesting site.

A technological advance for 21st century obstetricians: the electronically-controlled vacuum extractor.

PubMed

Perone, Nicola

2018-04-25

To describe an innovative electronically-controlled vacuum extractor (VE) in detail and to illustrate its performance characteristics, as observed in a laboratory study. Thirty simulated, vacuum-assisted deliveries. (1) The ability to measure in real-time of the pull applied and to sound an alert, when the traction approaches the negative pressure under the cup, to prevent its detachment. (2) The recording and printing of a graphic representation of the pull applied (vacuum delivery graph). (3) The emission of a warning signal when the 15-min time limit of continuous cup application on the fetal scalp, is reached. No cup detachment occurred in any of the 15 vacuum-assisted deliveries, in which traction was kept below the adhesive force of the cup [44 lb (20 kg)], except in three cases, due to loss of negative pressure. In the remaining 15 tests, in which traction was greater than the adhesive force of the cup, "pull-offs" inevitably occurred. Furthermore, upon reaching the 15-min time limit of continuous cup application on the fetal cephalic model, a warning signal was emitted, as programmed. Conclusions We demonstrated that the electronically-controlled VE, with its distinctive pull-sensing handle, performs suitably for its intended purposes. The ability of the modernized device to decrease the incidence of cup detachment, secondary to the inadvertent application of excessive traction, may result in considerable safety, medico-legal and didactic advantages.

Vacuum tool manipulator

DOEpatents

Zollinger, William T.

1993-01-01

Apparatus for manipulating a vacuum hose in a reactor vessel comprises a housing with two opposing openings, an arm carried by the housing and deployable from a stowed position essentially completely within the housing to an extended position where the arm extends through the two openings in a generally horizontal position. The arm preferably has a two-fingered gripping device for gripping the vacuum hose but may carry a different end effector such as a grinding wheel. The fingers are opened and closed by one air cylinder. A second air cylinder extends the device. A third air cylinder within the housing pivotally pulls the opposing end of the arm into the housing via a pivoting member pivotally connected between the third air cylinder shaft and the arm.

To ventricular assist devices or not: When is implantation of a ventricular assist device appropriate in advanced ambulatory heart failure?

PubMed Central

Cerier, Emily; Lampert, Brent C; Kilic, Arman; McDavid, Asia; Deo, Salil V; Kilic, Ahmet

2016-01-01

Advanced heart failure has been traditionally treated via either heart transplantation, continuous inotropes, consideration for hospice and more recently via left ventricular assist devices (LVAD). Heart transplantation has been limited by organ availability and the futility of other options has thrust LVAD therapy into the mainstream of therapy for end stage heart failure. Improvements in technology and survival combined with improvements in the quality of life have made LVADs a viable option for many patients suffering from heart failure. The question of when to implant these devices in those patients with advanced, yet still ambulatory heart failure remains a controversial topic. We discuss the current state of LVAD therapy and the risk vs benefit of these devices in the treatment of heart failure. PMID:28070237

Chronic outpatient management of patients with a left ventricular assist device

PubMed Central

Franzwa, Jennifer

2015-01-01

The use of mechanical circulatory support (MCS) as treatment for advanced heart failure (HF) has grown exponentially over the past 15 years. The continuous flow left ventricular assist device (CF-LVAD) has become the most used form of MCS in advanced HF, especially since approval of use as destination therapy (DT) and with the lack of organ availability. Long-term survival has improved and diligent outpatient management is thus particularly critical to achieve optimal outcomes. This review will discuss outpatient management strategies for patients with HF and a left ventricular assist device (LVAD). PMID:26793331

Assistive Technology Devices and Home Accessibility Features: Prevalence, Payment, Need, and Trends.

ERIC Educational Resources Information Center

LaPlante, Mitchell P.; And Others

1992-01-01

Presented is a report of findings of a 1990 National Health Interview Survey on Assistive Devices which indicated that about 5.3 percent of the American population are using assistive technology to accommodate physical impairments. Background information defines "assistive technology," describe uses, and reviews recent federal legislative and…

What the Psychiatrist Needs to Know About Ventricular Assist Devices: A Comprehensive Review.

PubMed

Caro, Mario A; Rosenthal, Julie L; Kendall, Kay; Pozuelo, Leopoldo; Funk, Margo C

2016-01-01

The number of patients with end-stage heart failure using mechanical circulatory support has dramatically increased over the past decade. Left ventricular assist devices, the most common type of mechanical circulatory support, can be used as a bridge to transplant, destination therapy, and as a bridge to recovery. As this patient population continues to grow, consultation-liaison psychiatrists will become increasingly involved in their care. A thorough biopsychosocial assessment is required to ensure adequate recognition and management of medical, psychiatric, social, and ethical challenges posed by this population. We performed a literature review to identify key issues relevant to the practice of consultation-liaison psychiatrists. General functioning of left ventricular assist devices, device types, system components, life with a left ventricular assist device, preoperative evaluation, treatment of psychiatric comorbidities, and end-of-life decision-making are discussed. Consultation-liaison psychiatrists need to be familiar with the high prevalence of psychopathology in patients implanted with left ventricular assist devices. A detailed biopsychosocial formulation is required to adequately identify and, if possible, resolve a myriad of medical, psychiatric, social, and ethical challenges presented by this population. Future efforts should accurately identify and report specific psychiatric disorders and adverse events within this cohort. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

21 CFR 884.5070 - Vacuum abortion system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vacuum abortion system. 884.5070 Section 884.5070 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 884.5070 Vacuum abortion system. (a) Identification. A vacuum abortion system is a device designed to...

21 CFR 884.5070 - Vacuum abortion system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Vacuum abortion system. 884.5070 Section 884.5070 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 884.5070 Vacuum abortion system. (a) Identification. A vacuum abortion system is a device designed to...

21 CFR 884.5070 - Vacuum abortion system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Vacuum abortion system. 884.5070 Section 884.5070 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 884.5070 Vacuum abortion system. (a) Identification. A vacuum abortion system is a device designed to...

21 CFR 884.5070 - Vacuum abortion system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vacuum abortion system. 884.5070 Section 884.5070 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 884.5070 Vacuum abortion system. (a) Identification. A vacuum abortion system is a device designed to...

21 CFR 884.5070 - Vacuum abortion system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vacuum abortion system. 884.5070 Section 884.5070 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 884.5070 Vacuum abortion system. (a) Identification. A vacuum abortion system is a device designed to...

Left ventricular assist device as destination therapy: application of the payment-by-results approach for the device reimbursement.

PubMed

Messori, Andrea; Trippoli, Sabrina; Bonacchi, Massimo; Sani, Guido

2009-08-01

Value-based methods are increasingly used to reimburse therapeutic innovation, and the payment-by-results approach has been proposed for handling interventions with limited therapeutic evidence. Because most left ventricular assist devices are supported by preliminary efficacy data, we examined the effectiveness data of the HeartMate (Thoratec Corp, Pleasanton, CA) device to explore the application of the payment-by-results approach to these devices and to develop a model for handling reimbursements. According to our model, after establishing the societal economic countervalue for each month of life saved, each patient treated with one such device is associated to the payment of this countervalue for every month of survival lived beyond the final date of estimated life expectancy without left ventricular assist devices. Our base-case analysis, which used the published data of 68 patients who received the HeartMate device, was run with a monthly countervalue of euro 5000, no adjustment for quality of life, and a baseline life expectancy of 150 days without left ventricular assist devices. Sensitivity analysis was aimed at testing the effect of quality of life adjustments and changes in life expectancy without device. In our base-case analysis, the mean total reimbursement per patient was euro 82,426 (range, euro 0 to euro 250,000; N = 68) generated as the sum of monthly payments. This average value was close to the current price of the HeartMate device (euro 75,000). Sensitivity testing showed that the base-case reimbursement of euro 82,426 was little influenced by variations in life expectancy, whereas variations in utility had a more pronounced impact. Our report delineates an innovative procedure for appropriately allocating economic resources in this area of invasive cardiology.

Vocational Reintegration of Handicapped Workers with Assistive Devices

ERIC Educational Resources Information Center

Cooper, N. E.

1977-01-01

Two approaches to vocational reintegration of handicapped workers are described: (1) adapting the disabled to the working environment through treatment, therapy, counseling, selective placement, and prostheses, and (2) adapting the working environment to particular handicaps, with the assistive device fitted to the machine or tool rather than to…

33 CFR 159.111 - Pressure and vacuum pulse test.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Pressure and vacuum pulse test... (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.111 Pressure and vacuum pulse test. Liquid retention components of the device with manufacturer specified venting...

33 CFR 159.111 - Pressure and vacuum pulse test.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Pressure and vacuum pulse test... (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.111 Pressure and vacuum pulse test. Liquid retention components of the device with manufacturer specified venting...

33 CFR 159.111 - Pressure and vacuum pulse test.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Pressure and vacuum pulse test... (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.111 Pressure and vacuum pulse test. Liquid retention components of the device with manufacturer specified venting...

Left Ventricular Assist Devices: The Adolescence of a Disruptive Technology.

PubMed

Pinney, Sean P

2015-10-01

Clinical outcomes for patients with advanced heart failure receiving left ventricular assist devices are driven by appropriate patient selection, refined surgical technique, and coordinated medical care. Perhaps even more important is innovative pump design. The introduction and widespread adoption of continuous-flow ventricular assist devices has led to a paradigm shift within the field of mechanical circulatory support, making the promise of lifetime device therapy closer to reality. The disruption caused by this new technology, on the one hand, produced meaningful improvements in patient survival and quality of life, but also introduced new clinical challenges, such as bleeding, pump thrombosis, and acquired valvular heart disease. Further evolution within this field will require financial investment to sustain innovation leading to a fully implantable, durable, and cost-effective pump for a larger segment of patients with advanced heart failure. Copyright © 2015 Elsevier Inc. All rights reserved.

Single-incision video-assisted anatomical segmentectomy with handsewn bronchial closure for endobronchial lipoma

PubMed Central

Sesma, Julio; Bolufer, Sergio; Lirio, Francisco; Navarro-Martinez, Jose; Galiana, Maria; Baschwitz, Benno; Rivera, Maria Jesus

2016-01-01

Endobronchial lipomas are rare benign tumors whose symptoms are usually confused with recurrent infections or even asthma diagnosis, and mostly caused by endobronquial obstructive component which also conditions severity. We report a case of a 60-year-old man with a right-lower lobe upper-segment endobronchial myxoid tumor with uncertain diagnosis. We performed a single incision video-assisted anatomical segmentectomy and wedge bronchoplasty with handsewn closure to achieve complete resection and definitive diagnosis. During the postoperative air leak was not observed and there was no complication, with low pain scores and complete recovery. Final pathological exam showed endobronchial lipoma. Single-incision (SI) anatomical segmentectomies are lung-sparing resections for benign or low-grade malignancies with diagnostic and therapeutic value, and the need for a wedge bronchoplasty is not a necessary indication for conversion to multiport or open thoracotomy. PMID:27570778

Single-incision video-assisted anatomical segmentectomy with handsewn bronchial closure for endobronchial lipoma.

PubMed

Galvez, Carlos; Sesma, Julio; Bolufer, Sergio; Lirio, Francisco; Navarro-Martinez, Jose; Galiana, Maria; Baschwitz, Benno; Rivera, Maria Jesus

2016-08-01

Endobronchial lipomas are rare benign tumors whose symptoms are usually confused with recurrent infections or even asthma diagnosis, and mostly caused by endobronquial obstructive component which also conditions severity. We report a case of a 60-year-old man with a right-lower lobe upper-segment endobronchial myxoid tumor with uncertain diagnosis. We performed a single incision video-assisted anatomical segmentectomy and wedge bronchoplasty with handsewn closure to achieve complete resection and definitive diagnosis. During the postoperative air leak was not observed and there was no complication, with low pain scores and complete recovery. Final pathological exam showed endobronchial lipoma. Single-incision (SI) anatomical segmentectomies are lung-sparing resections for benign or low-grade malignancies with diagnostic and therapeutic value, and the need for a wedge bronchoplasty is not a necessary indication for conversion to multiport or open thoracotomy.

Development of NASA-DeBakey Ventricular Assist Device Using Numerical Aerospace Simulation Technology

NASA Technical Reports Server (NTRS)

Kwak, Dochan

2000-01-01

Over three million Americans and 20 million people worldwide suffer from some form of heart failure. Mechanical heart assist devices are being used as a temporary support to sick ventricle and valves as a bridge-to-transplant or bridge-to-recovery. This viewgraph presentation gives an overview of the development of NASA-DeBakey Ventricular Assist Device (VAD) using numerical aerospace simulation technology.

Novel nonsurgical left ventricular assist device and system.

PubMed

Misiri, Juna; DeSimone, Christopher V; Park, Soon J; Kushwaha, Sudhir S; Friedman, Paul A; Bruce, Charles J; Asirvatham, Samuel J

2013-01-01

Treatment options for advanced stages of congestive heart failure remain limited. Left ventricular assist devices (LVADs) have emerged as a means to support failing circulation. However, these devices are not without significant risk such as major open chest surgery. We utilized a novel approach for device placement at the aorto-left atria continuity as a site to create a conduit capable of accommodating a percutaneous LVAD system. We designed and developed an expandable nitinol based device for placement at this site to create a shunt between the LA and aorta. Our experiments support this anatomic location as an accessible and feasible site for accommodation of an entirely percutaneous LVAD. The novelty of this approach would bypass the left ventricle, and thereby minimize complications and morbidities associated with current LVAD placement. Copyright © 2013 Elsevier Inc. All rights reserved.

Recent trends in the development and evaluation of assistive robotic manipulation devices.

PubMed

Allin, Sonya; Eckel, Emily; Markham, Heather; Brewer, Bambi R

2010-02-01

This review explores recent trends in the development and evaluation of assistive robotic arms, both prosthetic and externally mounted. Evaluations have been organized according to the CATOR taxonomy of assistive device outcomes, which takes into consideration device effectiveness, social significance, and impact on subjective well-being. Questions that have informed the review include: (1) Are robotic arms being comprehensively evaluated along axes of the CATOR taxonomy? (2) Are definitions of effectiveness in accordance with the priorities of users? (3) What gaps in robotic arm evaluation exist, and how might these best be addressed? (4) What further advances can be expected in the next 15 years? Results highlight the need for increased standardization of evaluation methods, increased emphasis on the social significance (i.e., social cost) of devices, and increased emphasis on device impact on quality of life. Several open areas for future research, in terms of both device evaluation and device development, are also discussed.

Utilising three-dimensional printing techniques when providing unique assistive devices: A case report.

PubMed

Day, Sarah Jane; Riley, Shaun Patrick

2018-02-01

The evolution of three-dimensional printing into prosthetics has opened conversations about the availability and cost of prostheses. This report will discuss how a prosthetic team incorporated additive manufacture techniques into the treatment of a patient with a partial hand amputation to create and test a unique assistive device which he could use to hold his French horn. Case description and methods: Using a process of shape capture, photogrammetry, computer-aided design and finite element analysis, a suitable assistive device was designed and tested. The design was fabricated using three-dimensional printing. Patient satisfaction was measured using a Pugh's Matrix™, and a cost comparison was made between the process used and traditional manufacturing. Findings and outcomes: Patient satisfaction was high. The three-dimensional printed devices were 56% cheaper to fabricate than a similar laminated device. Computer-aided design and three-dimensional printing proved to be an effective method for designing, testing and fabricating a unique assistive device. Clinical relevance CAD and 3D printing techniques can enable devices to be designed, tested and fabricated cheaper than when using traditional techniques. This may lead to improvements in quality and accessibility.

Can Vacuum Assisted Venous Drainage be Achieved using a Roller Pump in an Emergency? A Pilot Study using Neonatal Circuitry

PubMed Central

Hill, S. L.; Holt, D. W.

2007-01-01

Abstract: There has been much advancement in perfusion technology over its 50 years of progression. One of these techniques is vacuum-assisted venous drainage (VAVD). Many perfusionists augment venous drainage using VAVD, typically from a wall vacuum source. This study explores alternates to providing VAVD if the wall vacuum fails. In two porcine laboratories, ∼36 in. of 3/16-in. tubing was connected to a sucker return port and placed into the roller head next to the arterial pump. The vacuum was monitored with a DLP pressure monitoring system (Medtronic). This system was connected to small-bore tubing and attached to a stopcock on top of the reservoir. The vacuum was regulated using another stopcock connected to a non-filtered luer lock port on top of the reservoir or by a segment of 3 × 0.25-in.-diameter tubing attached to the vent port with a c-clamp. Vacuum drainage was achieved, ranging from −18 mmHg to −71 mmHg by manipulating the stopcock or c-clamp. Changes in venous drainage were seen by volume fluctuations in the venous reservoir. The vacuum was adjusted to account for dramatic changes. Augmented venous drainage using a roller pump can be achieved successfully during cardiopulmonary bypass (CPB). This method of active drainage can be used in lieu of wall suction or during times of emergency if wall suction fails. PMID:18293812

Pilot study of a novel vacuum-assisted method for decellularization of tracheae for clinical tissue engineering applications.

PubMed

Lange, P; Greco, K; Partington, L; Carvalho, C; Oliani, S; Birchall, M A; Sibbons, P D; Lowdell, M W; Ansari, T

2017-03-01

Tissue engineered tracheae have been successfully implanted to treat a small number of patients on compassionate grounds. The treatment has not become mainstream due to the time taken to produce the scaffold and the resultant financial costs. We have developed a method for decellularization (DC) based on vacuum technology, which when combined with an enzyme/detergent protocol significantly reduces the time required to create clinically suitable scaffolds. We have applied this technology to prepare porcine tracheal scaffolds and compared the results to scaffolds produced under normal atmospheric pressures. The principal outcome measures were the reduction in time (9 days to prepare the scaffold) followed by a reduction in residual DNA levels (DC no-vac: 137.8±48.82 ng/mg vs. DC vac 36.83±18.45 ng/mg, p<0.05.). Our approach did not impact on the collagen or glycosaminoglycan content or on the biomechanical properties of the scaffolds. We applied the vacuum technology to human tracheae, which, when implanted in vivo showed no significant adverse immunological response. The addition of a vacuum to a conventional decellularization protocol significantly reduces production time, whilst providing a suitable scaffold. This increases clinical utility and lowers production costs. To our knowledge this is the first time that vacuum assisted decellularization has been explored. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Need and availability of assistive devices to compensate for impaired hand function of individuals with tetraplegia.

PubMed

Wäckerlin, Stephanie; Gemperli, Armin; Sigrist-Nix, Diana; Arnet, Ursina

2018-06-04

Context/Objective To evaluate the availability and self-declared unmet need of assistive devices to compensate for impaired hand function of individuals with tetraplegia in Switzerland. Design Cross-sectional survey. Setting Community. Participants Individuals with tetraplegia, aged 16 years or older, living in Switzerland. Interventions not applicable. Outcome Measures The self-report availability and unmet need of 18 assistive devices for impaired hand function was analyzed descriptively. The availability of devices was further evaluated stratified by sex, age, SCI severity, independence in grooming, time since injury, living situation, working status, and income. Associations between availability of devices and person characteristics were investigated using logistic regression analysis. Results Overall 32.7% of participants had any assistive device for impaired hand function at their disposal. The most frequent devices were adapted cutlery (14.8%), type supports (14.1%), environmental control systems (11.4%), and writing orthosis (10.6%). In the bivariate analysis several factors showed significant associations with at least one assistive device. Nevertheless, when controlling for potential confounding in multivariate analysis only independence in grooming (adapted cutlery, environmental control systems, type support, speech recognition software), SCI severity (writing orthosis, type support), and sex (adapted kitchenware) remained significantly associated with the availability of the mentioned assistive devices. The self-declared unmet need was generally low (0.7% - 4.3%), except for adapted kitchenware with a moderate unmet need (8.9%). Conclusion This study indicates that most individuals with tetraplegia in Switzerland are adequately supplied with assistive devices to compensate for impaired hand function. The availability depends mainly on SCI severity and independence in grooming.

Deep inferior epigastric artery perforator flap donor-site closure with cannula-assisted, limited undermining, and progressive high-tension sutures versus standard abdominoplasty: complications, sensitivity, and cosmetic outcomes.

PubMed

Visconti, Giuseppe; Tomaselli, Federica; Monda, Anna; Barone-Adesi, Liliana; Salgarello, Marzia

2015-01-01

In deep inferior epigastric artery perforator (DIEP) flap breast reconstruction, abdominal donor-site cosmetic and sensibility outcomes and the closure technique have drawn little attention in the literature, with many surgeons still following the principles of standard abdominoplasty. In this article, the authors report their experience with the cannula-assisted, limited undermining, and progressive high-tension suture ("CALP") technique of DIEP donor-site closure compared with standard abdominoplasty. Between December of 2008 and January of 2013, 137 consecutive women underwent DIEP flap breast reconstruction. Of these, 82 patients (between December of 2008 and November of 2011) underwent DIEP flap donor-site closure by means of standard abdominoplasty (control group) and 55 patients (from December of 2011 to January of 2013) by means of cannula-assisted, limited undermining, and progressive high-tension suture (study group). The abdominal drainage daily output, donor-site complications, abdominal skin sensitivity at 1-year follow-up, cosmetic outcomes, and patient satisfaction were recorded and analyzed statistically. Daily drainage output was significantly lower in the study group. Donor-site complications were significantly higher in the control group (37.8 percent versus 9 percent). Seroma and wound healing problems were experienced in the control group. Abdominal skin sensibility was better preserved in the study group. Overall, abdominal wall aesthetic outcomes were similar in both groups, except for scar quality (better in the study group). According to the authors' experience, cannula-assisted, limited undermining, and progressive high-tension suture should be always preferred to standard abdominoplasty for DIEP donor-site closure to reduce the complication rate to improve abdominal skin sensitivity and scar quality. Therapeutic, II.

Anesthesia for left ventricular assist device insertion: a case series and review.

PubMed

Broussard, David; Donaldson, Emilie; Falterman, Jason; Bates, Michael

2011-01-01

From October 2008 to June 2010, a total of 42 patients had the HeartMate II left ventricular assist device inserted surgically at Ochsner Medical Center in New Orleans, LA. A retrospective electronic record review was conducted on this series of patients to analyze elements of perioperative anesthetic care, including general anesthetic care, echocardiographic considerations, and blood product usage. Etomidate was used to induce anesthesia for 34 of 42 patients (81%) in this series, with an average dose of 16.5 mg (±6 mg). The average intraoperative fentanyl dose was 1,318 µg (±631 µg). On average, patients were extubated 91 hours (±72 hours) after arrival to the intensive care unit and left on day 9 (±5 days). The average left ventricular ejection fraction of the patients in this series was 13% (±5%). Sixteen patients were evaluated as having severe right-heart dysfunction preoperatively. Two of 42 patients required surgical closure of echocardiographically identified patent foramen ovale. Twelve of 42 patients underwent surgical correction of tricuspid regurgitation. On average, 3 units (±2.6 units) of fresh frozen plasma were transfused intraoperatively and 10 units postoperatively. Intraoperative red blood cell usage averaged 1.1 units (maximum, 7 units), with an average 9.3 units administered in the first 48 hours postoperatively.

Vacuum tool manipulator

DOEpatents

Zollinger, W.T.

1993-11-23

Apparatus for manipulating a vacuum hose in a reactor vessel comprises a housing with two opposing openings, an arm carried by the housing and deployable from a stowed position essentially completely within the housing to an extended position where the arm extends through the two openings in a generally horizontal position. The arm preferably has a two-fingered gripping device for gripping the vacuum hose but may carry a different end effector such as a grinding wheel. The fingers are opened and closed by one air cylinder. A second air cylinder extends the device. A third air cylinder within the housing pivotally pulls the opposing end of the arm into the housing via a pivoting member pivotally connected between the third air cylinder shaft and the arm. 6 figures.

Casimir switch: steering optical transparency with vacuum forces.

PubMed

Liu, Xi-Fang; Li, Yong; Jing, H

2016-06-03

The Casimir force, originating from vacuum zero-point energy, is one of the most intriguing purely quantum effects. It has attracted renewed interests in current field of nanomechanics, due to the rapid size decrease of on-chip devices. Here we study the optomechanically-induced transparency (OMIT) with a tunable Casimir force. We find that the optical output rate can be significantly altered by the vacuum force, even terminated and then restored, indicating a highly-controlled optical switch. Our result addresses the possibility of designing exotic optical nano-devices by harnessing the power of vacuum.

Predictions of vacuum loss of evacuated vials from initial air leak rates.

PubMed

Prisco, Michael R; Ochoa, Jorge A; Yardimci, Atif M

2013-08-01

Container closure integrity is a critical factor for maintaining product sterility and stability. Therefore, closure systems (found in vials, syringes, and cartridges) are designed to provide a seal between rubber stoppers and glass containers. To ensure that the contained product has maintained its sterility and stability at the time of deployment, the seal must remain intact within acceptable limits. To this end, a mathematical model has been developed to describe vacuum loss in evacuated drug vials. The model computes equivalent leak diameter corresponding to initial air leak rate as well as vacuum loss as a function of time and vial size. The theory accounts for three flow regimes that may be encountered. Initial leak rates from 10(-8) to 10(3) sccm (standard cubic centimeters per minute) were investigated for vials ranging from 1 to 100 mL. Corresponding leak diameters of 0.25-173 μm were predicted. The time for a vial to lose half of its vacuum, the T50 value, ranged from many years at the lowest leak rates and largest vials, to fractions of a second at the highest leak rates and smallest vials. These results may be used to determine what level of initial vacuum leak is acceptable for a given product. Copyright © 2013 Wiley Periodicals, Inc.

Seven-year follow-up of percutaneous closure of patent foramen ovale.

PubMed

Mirzada, Naqibullah; Ladenvall, Per; Hansson, Per-Olof; Johansson, Magnus Carl; Furenäs, Eva; Eriksson, Peter; Dellborg, Mikael

2013-12-01

Observational studies favor percutaneous closure of patent foramen ovale (PFO) over medical treatment to reduce recurrent stroke while randomized trials fail to demonstrate significant superiority of percutaneous PFO closure. Few long-term studies are available post PFO closure. This study reports long-term clinical outcomes after percutaneous PFO closure. Between 1997 and 2006, 86 consecutive eligible patients with cerebrovascular events, presumably related to PFO, underwent percutaneous PFO closure. All 86 patients were invited to a long-term follow-up, which was carried out during 2011 and 2012. Percutaneous PFO closure was successfully performed in 85 of 86 patients. The follow-up rate was 100%. No cardiovascular or cerebrovascular deaths occurred. Two patients (both women) died from lung cancer during follow-up. Follow-up visits were conducted for 64 patients and the remaining 20 patients were followed up by phone. The mean follow-up time was 7.3 years (5 to 12.4 years). Mean age at PFO closure was 49 years. One patient had a minor stroke one month after PFO closure and a transient ischemic attack (TIA) two years afterwards. One other patient suffered from a TIA six years after closure. No long-term device-related complications were observed. Percutaneous PFO closure was associated with very low risk of recurrent stroke and is suitable in most patients. We observed no mortality and no long-term device-related complications related to PFO closure, indicating that percutaneous PFO closure is a safe and efficient treatment even in the long term.

Left Atrial Appendage Closure Device With Delivery System: A Health Technology Assessment

PubMed Central

Nevis, Immaculate; Falk, Lindsey; Wells, David; Higgins, Caroline

2017-01-01

Background Atrial fibrillation is a common cardiac arrhythmia, and 15% to 20% of those who have experienced stroke have atrial fibrillation. Treatment options to prevent stroke in people with atrial fibrillation include pharmacological agents such as novel oral anticoagulants or nonpharmacological devices such as the left atrial appendage closure device with delivery system (LAAC device). The objectives of this health technology assessment were to assess the clinical effectiveness and cost-effectiveness of the LAAC device versus novel oral anticoagulants in patients without contraindications to oral anticoagulants and versus antiplatelet agents in patients with contraindications to oral anticoagulants. Methods We performed a systematic review and network meta-analysis. We also conducted an economic literature review, economic evaluation, and budget impact analysis to assess the cost-effectiveness and budget impact of the LAAC device compared with novel oral anticoagulants and oral antiplatelet agents (e.g., aspirin). We also spoke with patients to better understand their preferences, perspectives, and values. Results Seven randomized controlled studies met the inclusion criteria for indirect comparison. Five studies assessed the effectiveness of novel oral anticoagulants versus warfarin, and two studies compared the LAAC device with warfarin. No studies were identified that compared the LAAC device with aspirin in patients in whom oral anticoagulants were contraindicated. Using the random effects model, we found that the LAAC device was comparable to novel oral anticoagulants in reducing stroke (odds ratio [OR] 0.85; credible interval [Cr.I] 0.63–1.05). Similarly, the reduction in the risk of all-cause mortality was comparable between the LAAC device and novel oral anticoagulants (OR 0.71; Cr.I 0.49–1.22). The LAAC device was found to be superior to novel oral anticoagulants in preventing hemorrhagic stroke (OR 0.45; Cr.I 0.29–0.79), whereas novel oral

Constrained optimization framework for interface-aware sub-scale dynamics models for voids closure in Lagrangian hydrodynamics

DOE PAGES

Barlow, Andrew; Klima, Matej; Shashkov, Mikhail

2018-04-02

In hydrocodes, voids are used to represent vacuum and model free boundaries between vacuum and real materials. We give a systematic description of a new treatment of void closure in the framework of the multimaterial arbitrary Lagrangian–Eulerian (ALE) methods. This includes a new formulation of the interface-aware sub-scale-dynamics (IA-SSD) closure model for multimaterial cells with voids, which is used in the Lagrangian stage of our indirect ALE scheme. The results of the comprehensive testing of the new model are presented for one- and two-dimensional multimaterial calculations in the presence of voids. Finally, we also present a sneak peek of amore » realistic shaped charge calculation in the presence of voids and solids.« less

Constrained optimization framework for interface-aware sub-scale dynamics models for voids closure in Lagrangian hydrodynamics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barlow, Andrew; Klima, Matej; Shashkov, Mikhail

In hydrocodes, voids are used to represent vacuum and model free boundaries between vacuum and real materials. We give a systematic description of a new treatment of void closure in the framework of the multimaterial arbitrary Lagrangian–Eulerian (ALE) methods. This includes a new formulation of the interface-aware sub-scale-dynamics (IA-SSD) closure model for multimaterial cells with voids, which is used in the Lagrangian stage of our indirect ALE scheme. The results of the comprehensive testing of the new model are presented for one- and two-dimensional multimaterial calculations in the presence of voids. Finally, we also present a sneak peek of amore » realistic shaped charge calculation in the presence of voids and solids.« less

The immediate use of a silicone sheet wound closure device in scar reduction and prevention.

PubMed

Parry, James R; Stupak, Howard D; Johnson, Calvin M

2016-02-01

Silicone has been used successfully postoperatively in the prevention of hypertrophic and other types of adverse scars. The Silicone Suture Plate (SSP) is a new, minimally invasive, sterile wound closure device that is applied intraoperatively to prevent adverse scarring. The SSP device permits immediate application of silicone while concurrently allowing for wound-edge tension redistribution. In this prospective, controlled, single-blinded clinical study, 8 consecutive patients undergoing deep-plane rhytidectomy were selected. SSP devices were placed on the patients' posterior rhytidectomy hairline incision; the mirror-image control site underwent standard suturing techniques. Three blinded, independent raters assessed the treatment and control sides at 6-week and 4-month follow-up visits, using the Objective Scar Assessment Scale (OSAS), a validated scar assessment tool. The 6-week OSAS scores revealed an 18.4% improvement on the side with the SSP device (13.3) when compared to the control side (16.3). The 4-month OSAS scores showed a 27.3% improvement on the treatment side from 12.7 (control) to 9.2 (SSP). These OSAS results were found to be statistically significant when taken as an aggregate of the observers' scores, but not when observers' scores were measured individually (p < 0.05). In our series of patients, we showed promising results with the use of the SSP device. Early silicone application and tissue tension distribution contributed to an overall more aesthetically pleasing scar compared to those seen with standard suturing techniques, although more testing is required.

Outcomes of mechanical stapling for postlaryngectomy open pharyngotomy closure.

PubMed

Paddle, Paul; Husain, Inna; McHugh, Lauren; Franco, Ramon

2017-03-01

A total laryngectomy (TL) is performed as a primary or salvage therapy for laryngeal carcinoma. Pharyngotomy closure after TL is typically performed using manual sutures. Automatic stapling devices are routinely used in thoracoabdominal surgery, but have not been widely accepted for use in pharyngotomy closure. Previously described closed stapling techniques of pharyngeal closure do not allow direct evaluation of surgical margins and are limited to endolaryngeal disease. We describe an open technique for pharyngotomy closure using a mechanical stapling device. Retrospective review. A review was conducted of 16 total laryngectomies performed from May 2008 to August 2015 utilizing an Ethicon Endopath ETS Compact-Flex 45 stapler. Sixteen patients (15 male, one female), mean age 69 years, received open TL (14 salvage, two primary) with endostapler pharyngeal closure and primary tracheoesophageal puncture (TEP). Surgical time averaged 218 minutes. Median time to swallowing was 4 days (range, 2-240 days) and mean hospital stay 6 days (range, 3-10 days). Fistula incidence was 31% (5/16) overall and 36% (5/14) in the postradiation patients. Mechanical stapling is a simple method for postlaryngectomy open pharyngotomy closure. This technique allows evaluation of margins, easy primary TEP, and the opportunity for early swallowing and shorter hospital stays. In addition, it can be performed for closure of salvage laryngectomies with rates of fistula formation similar to that found in the literature using suture closure techniques. Future studies are necessary to compare oncological results and surgical complications between the open and closed stapling techniques and to traditional suture closure. 4 Laryngoscope, 127:605-610, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Percutaneous closure of patent foramen ovale without echocardiographic guidance.

PubMed

Jamshidi, Peiman; Wahl, Andreas; Windecker, Stephan; Schwerzmann, Markus; Seiler, Christian; Meier, Bernhard

2007-01-01

A percutaneous patent foramen ovale (PFO) closure procedure includes transesophageal or intracardiac echocardiographic guidance at many centers. We investigated the feasibility and complications of the PFO closure without echocardiography. A total of 420 consecutive patients (185 women and 235 men, mean age 51 +/- 12 years) underwent percutaneous PFO closure without echocardiographic guidance using 7 different devices. Of these, 106 patients (25%) had an associated atrial septal aneurysm. The implantation was successful in 418 patients (99%). There were 12 procedural complications (3%), including embolization of the device or of parts of it with successful percutaneous removal in 5 cases, pericardial tamponade requiring pericardiocentesis in 1 patient, air embolism with transient symptoms in 3 patients, and vascular access problems in 3 patients. In none of the cases, echocardiography had to be summoned during the case or its lack was associated with acute or subsequent problems. The fluoroscopy time and procedure time were 5.4 +/- 2.7 and 25 +/- 17 minutes, respectively. Transthoracic contrast echocardiography, 24 hours after device implantation, detected a residual shunt in 19% of the patients. Percutaneous PFO closure with fluoroscopic guidance only is feasible and has low complication rates, especially with Amplatzer PFO Occluders. The added time and cost of echocardiography during the procedure is not warranted.

CT based 3D printing is superior to transesophageal echocardiography for pre-procedure planning in left atrial appendage device closure.

PubMed

Obasare, Edinrin; Mainigi, Sumeet K; Morris, D Lynn; Slipczuk, Leandro; Goykhman, Igor; Friend, Evan; Ziccardi, Mary Rodriguez; Pressman, Gregg S

2018-05-01

Accurate assessment of the left atrial appendage (LAA) is important for pre-procedure planning when utilizing device closure for stroke reduction. Sizing is traditionally done with transesophageal echocardiography (TEE) but this is not always precise. Three-dimensional (3D) printing of the LAA may be more accurate. 24 patients underwent Watchman device (WD) implantation (71 ± 11 years, 42% female). All had complete 2-dimensional TEE. Fourteen also had cardiac computed tomography (CCT) with 3D printing to produce a latex model of the LAA for pre-procedure planning. Device implantation was unsuccessful in 2 cases (one with and one without a 3D model). The model correlated perfectly with implanted device size (R 2  = 1; p < 0.001), while TEE-predicted size showed inferior correlation (R 2  = 0.34; 95% CI 0.23-0.98, p = 0.03). Fisher's exact test showed the model better predicted final WD size than TEE (100 vs. 60%, p = 0.02). Use of the model was associated with reduced procedure time (70 ± 20 vs. 107 ± 53 min, p = 0.03), anesthesia time (134 ± 31 vs. 182 ± 61 min, p = 0.03), and fluoroscopy time (11 ± 4 vs. 20 ± 13 min, p = 0.02). Absence of peri-device leak was also more likely when the model was used (92 vs. 56%, p = 0.04). There were trends towards reduced trans-septal puncture to catheter removal time (50 ± 20 vs. 73 ± 36 min, p = 0.07), number of device deployments (1.3 ± 0.5 vs. 2.0 ± 1.2, p = 0.08), and number of devices used (1.3 ± 0.5 vs. 1.9 ± 0.9, p = 0.07). Patient specific models of the LAA improve precision in closure device sizing. Use of the printed model allowed rapid and intuitive location of the best landing zone for the device.

Self-testing security sensor for monitoring closure of vault doors and the like

DOEpatents

Cawthorne, Duane C.

1997-05-27

A self-testing device is provided for a monitoring system for monitoring whether a closure member such as a door or window is closed. The monitoring system includes a switch unit mounted on the frame of the closure member being monitored and including magnetically biased switches connected in one or more electrical monitoring circuits, and a door magnet unit mounted on the closure member being monitored. The door magnet includes one or more permanent magnets that produce a magnetic field which, when the closure member is closed, cause said switches to assume a first state. When the closure member is opened, the switches switch to a second, alarm state. The self-testing device is electrically controllable from a remote location and produces a canceling or diverting magnetic field which simulates the effect of movement of the closure member from the closed position thereof without any actual movement of the member.

46 CFR 105.10-20 - Pressure vacuum relief valve.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Pressure vacuum relief valve. (a) The term pressure vacuum relief valve means any device or assembly of a mechanical, liquid, weight, or other type used for the automatic regulation of pressure or vacuum in enclosed... 46 Shipping 4 2011-10-01 2011-10-01 false Pressure vacuum relief valve. 105.10-20 Section 105.10...

46 CFR 105.10-20 - Pressure vacuum relief valve.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Pressure vacuum relief valve. (a) The term pressure vacuum relief valve means any device or assembly of a mechanical, liquid, weight, or other type used for the automatic regulation of pressure or vacuum in enclosed... 46 Shipping 4 2010-10-01 2010-10-01 false Pressure vacuum relief valve. 105.10-20 Section 105.10...

46 CFR 105.10-20 - Pressure vacuum relief valve.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Pressure vacuum relief valve. (a) The term pressure vacuum relief valve means any device or assembly of a mechanical, liquid, weight, or other type used for the automatic regulation of pressure or vacuum in enclosed... 46 Shipping 4 2014-10-01 2014-10-01 false Pressure vacuum relief valve. 105.10-20 Section 105.10...

46 CFR 105.10-20 - Pressure vacuum relief valve.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Pressure vacuum relief valve. (a) The term pressure vacuum relief valve means any device or assembly of a mechanical, liquid, weight, or other type used for the automatic regulation of pressure or vacuum in enclosed... 46 Shipping 4 2012-10-01 2012-10-01 false Pressure vacuum relief valve. 105.10-20 Section 105.10...

46 CFR 105.10-20 - Pressure vacuum relief valve.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Pressure vacuum relief valve. (a) The term pressure vacuum relief valve means any device or assembly of a mechanical, liquid, weight, or other type used for the automatic regulation of pressure or vacuum in enclosed... 46 Shipping 4 2013-10-01 2013-10-01 false Pressure vacuum relief valve. 105.10-20 Section 105.10...

Surface Effects and Challenges for Application of Piezoelectric Langasite Substrates in Surface Acoustic Wave Devices Caused by High Temperature Annealing under High Vacuum.

PubMed

Seifert, Marietta; Rane, Gayatri K; Kirbus, Benjamin; Menzel, Siegfried B; Gemming, Thomas

2015-12-19

Substrate materials that are high-temperature stable are essential for sensor devices which are applied at high temperatures. Although langasite is suggested as such a material, severe O and Ga diffusion into an O-affine deposited film was observed during annealing at high temperatures under vacuum conditions, leading to a damage of the metallization as well as a change of the properties of the substrate and finally to a failure of the device. Therefore, annealing of bare LGS (La 3 Ga 5 SiO 14 ) substrates at 800 ∘ C under high vacuum conditions is performed to analyze whether this pretreatment improves the suitability and stability of this material for high temperature applications in vacuum. To reveal the influence of the pretreatment on the subsequently deposited metallization, RuAl thin films are used as they are known to oxidize on LGS at high temperatures. A local study of the pretreated and metallized substrates using transmission electron microscopy reveals strong modification of the substrate surface. Micro cracks are visible. The composition of the substrate is strongly altered at those regions. Severe challenges for the application of LGS substrates under high-temperature vacuum conditions arise from these substrate damages, revealing that the pretreatment does not improve the applicability.

An assessment of the hardness of miniature vacuum tubes to high-voltage transients

DOE Office of Scientific and Technical Information (OSTI.GOV)

Orvis, W.J.

1990-03-01

Miniature vacuum tubes are vacuum switching and control devices fabricated on a silicon wafer, using the same technology as is used to make integrated circuits. They operate in much the same manner as conventional vacuum tubes, but with two important differences: they are micron sized devices, and they employ field emission instead of thermionic emission as the electron source. As these devices have a vacuum as their active region, they will be extremely hard to nuclear radiation and relatively insensitive to temperature effects, they are also expected to be extremely fast devices. We have estimated here that their hardness tomore » high-voltage transients will be at least as good as existing semiconductor devices and possibly better. 5 figs.« less

Magnet-assisted device-level alignment for the fabrication of membrane-sandwiched polydimethylsiloxane microfluidic devices

NASA Astrophysics Data System (ADS)

Lu, J.-C.; Liao, W.-H.; Tung, Y.-C.

2012-07-01

Polydimethylsiloxane (PDMS) microfluidic device is one of the most essential techniques that advance microfluidics research in recent decades. PDMS is broadly exploited to construct microfluidic devices due to its unique and advantageous material properties. To realize more functionalities, PDMS microfluidic devices with multi-layer architectures, especially those with sandwiched membranes, have been developed for various applications. However, existing alignment methods for device fabrication are mainly based on manual observations, which are time consuming, inaccurate and inconsistent. This paper develops a magnet-assisted alignment method to enhance device-level alignment accuracy and precision without complicated fabrication processes. In the developed alignment method, magnets are embedded into PDMS layers at the corners of the device. The paired magnets are arranged in symmetric positions at each PDMS layer, and the magnetic attraction force automatically pulls the PDMS layers into the aligned position during assembly. This paper also applies the method to construct a practical microfluidic device, a tunable chaotic micromixer. The results demonstrate the successful operation of the device without failure, which suggests the accurate alignment and reliable bonding achieved by the method. Consequently, the fabrication method developed in this paper is promising to be exploited to construct various membrane-sandwiched PDMS microfluidic devices with more integrated functionalities to advance microfluidics research.

Association of HeartMate II left ventricular assist device flow estimate with thermodilution cardiac output.

PubMed

Hasin, Tal; Huebner, Marianne; Li, Zhuo; Brown, Daniel; Stulak, John M; Boilson, Barry A; Joyce, Lyle; Pereira, Naveen L; Kushwaha, Sudhir S; Park, Soon J

2014-01-01

Cardiac output (CO) assessment is important in treating patients with heart failure. Durable left ventricular assist devices (LVADs) provide essentially all CO. In currently used LVADs, estimated device flow is generated by a computerized algorithm. However, LVAD flow estimate may be inaccurate in tracking true CO. We correlated LVAD (HeartMate II) flow with thermodilution CO during postoperative care (day 2-10 after implant) in 81 patients (5,616 paired measurements). Left ventricular assist device flow and CO correlated with a low correlation coefficient (r = 0.42). Left ventricular assist device readings were lower than CO measurements by approximately 0.36 L/min, trending for larger difference with higher values. Left ventricular assist device flow measurements showed less temporal variability compared with CO. Grouping for simultaneous measured blood pressure (BP < 60, 60-70, 70-80, 80-90, and ≥90), the correlation of CO with LVAD flow differed (R = 0.42, 0.67, 0.48, 0.32, 0.32, respectively). Indicating better correlation when mean blood pressure is 60 to 70 mm Hg. Left ventricular assist device flow generally trends with measured CO, but large variability exists, hence flow measures should not be assumed to equal with CO. Clinicians should take into account variables such as high CO, BP, and opening of the aortic valve when interpreting LVAD flow readout. Direct flow sensors incorporated in the LVAD system may allow for better estimation.

Intraoperative bronchoscopic visualization of left ventricular assist device thrombus.

PubMed

Yost, Gardner; Bhat, Geetha; Modi, Sejal; Pappas, Pat; Tatooles, Antone

2016-07-01

Despite advancements in left ventricular assist device (LVAD) design and clinical management, device thrombosis remains a pertinent complication. Limited imaging makes precise visualization of clot location and shape very challenging. We report the usage of videobronchoscopic exploration of explanted LVADs for direct visualization of clot in two patients. This technique is a rapid and inexpensive means of improving our understanding of LVAD clot formation and may be useful in surgical exploration of inflow and outflow tracts during LVAD exchange. © The Author(s) 2015.

Endocarditis in left ventricular assist device

PubMed Central

Thyagarajan, Braghadheeswar; Kumar, Monisha Priyadarshini; Sikachi, Rutuja R; Agrawal, Abhinav

2016-01-01

Summary Heart failure is one of the leading causes of death in developed nations. End stage heart failure often requires cardiac transplantation for survival. The left ventricular assist device (LVAD) has been one of the biggest evolvements in heart failure management often serving as bridge to transplant or destination therapy in advanced heart failure. Like any other medical device, LVAD is associated with complications with infections being reported in many patients. Endocarditis developing secondary to the placement of LVAD is not a frequent, serious and difficult to treat condition with high morbidity and mortality. Currently, there are few retrospective studies and case reports reporting the same. In our review, we found the most common cause of endocarditis in LVAD was due to bacteria. Both bacterial and fungal endocarditis were associated with high morbidity and mortality. In this review we will be discussing the risk factors, organisms involved, diagnostic tests, management strategies, complications, and outcomes in patients who developed endocarditis secondary to LVAD placement. PMID:27672540

Wafer-level vacuum/hermetic packaging technologies for MEMS

NASA Astrophysics Data System (ADS)

Lee, Sang-Hyun; Mitchell, Jay; Welch, Warren; Lee, Sangwoo; Najafi, Khalil

2010-02-01

An overview of wafer-level packaging technologies developed at the University of Michigan is presented. Two sets of packaging technologies are discussed: (i) a low temperature wafer-level packaging processes for vacuum/hermeticity sealing, and (ii) an environmentally resistant packaging (ERP) technology for thermal and mechanical control as well as vacuum packaging. The low temperature wafer-level encapsulation processes are implemented using solder bond rings which are first patterned on a cap wafer and then mated with a device wafer in order to encircle and encapsulate the device at temperatures ranging from 200 to 390 °C. Vacuum levels below 10 mTorr were achieved with yields in an optimized process of better than 90%. Pressures were monitored for more than 4 years yielding important information on reliability and process control. The ERP adopts an environment isolation platform in the packaging substrate. The isolation platform is designed to provide low power oven-control, vibration isolation and shock protection. It involves batch flip-chip assembly of a MEMS device onto the isolation platform wafer. The MEMS device and isolation structure are encapsulated at the wafer-level by another substrate with vertical feedthroughs for vacuum/hermetic sealing and electrical signal connections. This technology was developed for high performance gyroscopes, but can be applied to any type of MEMS device.

Vacuum microelectronics for beam power and rectennas

NASA Technical Reports Server (NTRS)

Gray, Henry F.

1989-01-01

Vacuum Microelectronic devices can be described as vacuum transistors or micro-miniature vacuum tubes, as one chooses. The fundamental reason behind this new technology is the very large current densities available from field emitters, namely as high as 10(8) A/sq cm. Array current densities as high as 1000 A/sq cm have been measured. Total electron transit times from source to drain for 1 micron feature size devices have been predicted to be about 150fs. This very short transit time implies the possibility of submillimeter wave transmitters and rectennas in devices which can operate with reasonably high voltages and which are small in size and are lightweight. In addition, they are expected to be extremely radiation hard and very temperature insensitive. That is, they are expected to have radiation hardness characteristics similar to vacuum tubes, and both the high temperature and low temperature limits should be determined by the package. That is, there should be no practical intrinsic temperature or carrier freezeout problems for devices based on metals or composites. But the technology is difficult to implement at the present time because it is based on 300 to 500 angstrom radius field emitters which must be relatively uniform. There is also the need to understand the non-equilibrium transport physics in the near-surface regions of the field emitters.

Influence of Gap Distance on Vacuum Arc Characteristics of Cup Type AMF Electrode in Vacuum Interrupters

NASA Astrophysics Data System (ADS)

Cheng, Shaoyong; Xiu, Shixin; Wang, Jimei; Shen, Zhengchao

2006-11-01

The greenhouse effect of SF6 is a great concern today. The development of high voltage vacuum circuit breakers becomes more important. The vacuum circuit breaker has minimum pollution to the environment. The vacuum interrupter is the key part of a vacuum circuit breaker. The interrupting characteristics in vacuum and arc-controlling technique are the main problems to be solved for a longer gap distance in developing high voltage vacuum interrupters. To understand the vacuum arc characteristics and provide effective technique to control vacuum arc in a long gap distance, the arc mode transition of a cup-type axial magnetic field electrode is observed by a high-speed charge coupled device (CCD) video camera under different gap distances while the arc voltage and arc current are recorded. The controlling ability of the axial magnetic field on vacuum arc obviously decreases when the gap distance is longer than 40 mm. The noise components and mean value of the arc voltage significantly increase. The effective method for controlling the vacuum arc characteristics is provided by long gap distances based on the test results. The test results can be used as a reference to develop high voltage and large capacity vacuum interrupters.

Self-testing security sensor for monitoring closure of vault doors and the like

DOEpatents

Cawthorne, D.C.

1997-05-27

A self-testing device is provided for a monitoring system for monitoring whether a closure member such as a door or window is closed. The monitoring system includes a switch unit mounted on the frame of the closure member being monitored and including magnetically biased switches connected in one or more electrical monitoring circuits, and a door magnet unit mounted on the closure member being monitored. The door magnet includes one or more permanent magnets that produce a magnetic field which, when the closure member is closed, cause said switches to assume a first state. When the closure member is opened, the switches switch to a second, alarm state. The self-testing device is electrically controllable from a remote location and produces a canceling or diverting magnetic field which simulates the effect of movement of the closure member from the closed position thereof without any actual movement of the member. 5 figs.

Assistive Device Use as a Dynamic Acquisition Process in Later Life

ERIC Educational Resources Information Center

Pressler, Karis A.; Ferraro, Kenneth F.

2010-01-01

Purpose: This study identifies risk factors, including incident disability, for the use of assistive devices (ADs) among older people. Design and Methods: Three waves of data from the National Long-Term Care Survey (NLTCS) are used to examine whether upper and lower body disability lead to use of ADs (both number of devices used and number of…

[Analysis of using assistive devices by patients suffering from cerebral palsy - preliminary report].

PubMed

Zeńczak-Praga, Krystyna; Zgorzalewicz-Stachowiak, Małgorzata; Cesar, Kinga

2015-11-01

Cerebral palsy (CP) is still significant health and social issue in the world. Adults who suffer from that illness have problem with mobility which make their functioning much harder. Common symptoms include spasticity, chronic pain of musculoskeletal system, disturbance of sensation, epilepsy or mental retardation. The aim of the study was analysis of assistive devices used by patients with CP through childhood and adulthood. The results were compared with the situation in this field of CP patients in other countries. The study involved 30 patients with CP in age between 20-43 living in Poznan and under the care of Occupational Therapy Workshop and Enviromental Self-help Houses. The research method was questionnaire which was directed to caregivers of adults with CP. They were asked about diagnosis, accompanying symptoms as well as assistive devices used during childhood and adulthood. During childhood wheelchair and standing frame were used the most often while during adulthood the most common were also the first mentioned above as well as rehabilitation lift. Although unfavourable evaluation of fitting assistive devices, majority of caregivers of CP sufferer claimed that there was varying improvement in patients motor functionality. Comprehensive rehabilitation and assistive devices are necessary for patients with CP during adulthood not less than during childhood. Wheelchairs are even more essential for adults than for children. © 2015 MEDPRESS.

Mobile Learning as Alternative to Assistive Technology Devices for Special Needs Students

ERIC Educational Resources Information Center

Ismaili, Jalal; Ibrahimi, El Houcine Ouazzani

2017-01-01

Assistive Technology (AT) revolutionized the process of learning for special needs students during the past three decades. Thanks to this technology, accessibility and educational inclusion became attainable more than any time in the history of special education. Meanwhile, assistive technology devices remain unreachable for a large number of…

A squeezed light source operated under high vacuum

PubMed Central

Wade, Andrew R.; Mansell, Georgia L.; Chua, Sheon S. Y.; Ward, Robert L.; Slagmolen, Bram J. J.; Shaddock, Daniel A.; McClelland, David E.

2015-01-01

Non-classical squeezed states of light are becoming increasingly important to a range of metrology and other quantum optics applications in cryptography, quantum computation and biophysics. Applications such as improving the sensitivity of advanced gravitational wave detectors and the development of space-based metrology and quantum networks will require robust deployable vacuum-compatible sources. To date non-linear photonics devices operated under high vacuum have been simple single pass systems, testing harmonic generation and the production of classically correlated photon pairs for space-based applications. Here we demonstrate the production under high-vacuum conditions of non-classical squeezed light with an observed 8.6 dB of quantum noise reduction down to 10 Hz. Demonstration of a resonant non-linear optical device, for the generation of squeezed light under vacuum, paves the way to fully exploit the advantages of in-vacuum operations, adapting this technology for deployment into new extreme environments. PMID:26657616

A squeezed light source operated under high vacuum

NASA Astrophysics Data System (ADS)

Wade, Andrew R.; Mansell, Georgia L.; Chua, Sheon S. Y.; Ward, Robert L.; Slagmolen, Bram J. J.; Shaddock, Daniel A.; McClelland, David E.

2015-12-01

Non-classical squeezed states of light are becoming increasingly important to a range of metrology and other quantum optics applications in cryptography, quantum computation and biophysics. Applications such as improving the sensitivity of advanced gravitational wave detectors and the development of space-based metrology and quantum networks will require robust deployable vacuum-compatible sources. To date non-linear photonics devices operated under high vacuum have been simple single pass systems, testing harmonic generation and the production of classically correlated photon pairs for space-based applications. Here we demonstrate the production under high-vacuum conditions of non-classical squeezed light with an observed 8.6 dB of quantum noise reduction down to 10 Hz. Demonstration of a resonant non-linear optical device, for the generation of squeezed light under vacuum, paves the way to fully exploit the advantages of in-vacuum operations, adapting this technology for deployment into new extreme environments.

Temporary Abdominal Closure Combined With an Irrigating System Utilizing Hypochlorous Acid Solution to Decrease Abdominal Mucopurulence

PubMed Central

Matthews, Marc R.; Quan, Asia N.; Weir, Alexandra S.; Foster, Kevin N.; Caruso, Daniel M.