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Sample records for expandable nitinol stent

  1. Nitinol Self-Expanding Stents for the Superficial Femoral Artery.

    PubMed

    Nathan, Ashwin; Kobayashi, Taisei; Giri, Jay

    2017-04-01

    The superficial femoral artery is a complex artery subject to a unique set of biomechanical loading conditions in its course through the leg. Plain balloon angioplasty and balloon-expandable stents had unacceptably high rates of restenosis, necessitating target vessel revascularization. Nitinol alloy is well suited to provide the strength and flexibility needed of stents to withstand the external forces posed by the environment of the superficial femoral artery. Advances in stent technology with the addition of a slow-releasing antiproliferative agent and changes in scaffold design have shown promise in reducing the rates of stent fracture and in-stent restenosis.

  2. Self-Expandable Nitinol Stent Placement in Homocysteinemic Porcine Aorta

    PubMed Central

    França, Luís Henrique Gil; Pereira, Adamastor Humberto; Perini, Sílvio César

    2008-01-01

    PURPOSE To compare aortic intimal thickening of normal and hyperhomocysteinemic pigs (induced with a methionine-rich diet) following placement of a self-expanding nitinol stent. METHODS Eighteen Macau pigs were used. They were older than eight weeks in age and had an average weight of 30 kg. Pigs were randomly divided into two groups. The first, Group C (control), was fed a regular diet, and the second group, Group M, was fed a methionine-rich diet for 30 days to induce hyperhomocysteinemia. The self-expandable nitinol stents were 25mm in length and 8 mm in diameter after expansion. Blood samples were collected to measure total cholesterol, triglycerides, HDL and homocysteine concentrations. All animals were subjected to angiography. Thirty days after the procedure, the animals were sacrificed, and the abdominal aorta was removed for histological and digital morphometry analysis. RESULTS Under microscopic evaluation, the intima was significantly thicker in Group C than in Group M. When groups were compared by digital morphometric analysis, intimal thickening of the vessel wall was higher in Group C than in Group M. There was no significant change in total cholesterol, triglycerides or HDL concentrations in either group. In group C the levels of plasma homocysteine ranged from 14,40 to 16,73μmol/l; in Group M, plasma homocysteine levels ranged from 17.47 to 59.80 μmol/l after 30 days of a methionine-rich diet. CONCLUSION Compared to normal pigs, less intimal hyperplasia was observed in the abdominal aortas of hyperhomocysteinemic pigs thirty days after the insertion of a self-expandable nitinol stent. PMID:18438578

  3. Use of nitinol self-expandable stents in 26 dogs with tracheal collapse.

    PubMed

    Beranek, J; Jaresova, H; Rytz, U

    2014-02-01

    A study was designed to describe a novel approach to the treatment of tracheal collapse (TC) in dogs using self-expandable nitinol stents. Medical records were reviewed retrospectively for 26 client owned dogs in which nitinol stents were deployed. The entire length of trachea was supported independently of the extent of TC. Two overlapping stents were used instead of one in cases where one stent was not spanning the entire trachea adequately. The diameter of the cranial radiolucent portion of trachea, just behind the cricoid cartilage, was measured as a specific landmark to select the appropriate size of the stent. Two self-expandable nitinol stents were inserted in 9 of 26 dogs; the trachea in the rest of the cases was supported with only one stent. A follow up tracheoscopy was performed in 10 of 26 cases with recurrent clinical signs. Secondary tracheal stenosis in these cases was caused by stent fracture, granuloma or excessive stent shortening. Additional stents were placed successfully to expand the stenotic lumen. A support of the entire trachea may decrease risk of nitinol fracture at the end of the implant. Long term clinical improvement (25 of 26 dogs, 96 %) is comparable with the results of other studies.

  4. Treatment of Benign Tracheal Stenosis Utilizing Self-Expanding Nitinol Stents

    SciTech Connect

    Sesterhenn, Andreas M. Wagner, Hans-Joachim; Alfke, Heiko; Werner, Jochen A.; Lippert, Burkard M.

    2004-08-15

    We assessed the results of self-expanding metallic stent insertion into benign proximal tracheal stenosis in patients not appropriate or unfit for surgical repair. Proximal benign tracheal stenoses had occurred in 11 patients (7 men, 4 women, mean age 68.8 years) after long-time intubation (n = 6), tracheostomy (n = 4), or chondropathia (n = 1). Fourteen self-expanding nitinol stents were placed in the patients under general anesthesia with endoscopical and fluoroscopical guidance. Stent insertion was successful in all cases and led to immediate relief of the morphological and functional airway obstruction. No immediate complications were noted. During the mean follow-up period of 67.5 weeks we observed one recurrent dyspnea 3 months after implantation and granuloma formation at the stent insertion site in another patient. Both complications were successfully treated with additional stent insertion in one case and laser resection of granulomas in the other. Self-expanding nitinol stents should be considered for the treatment of benign proximal tracheal obstruction in selected patients for whom surgical repair is contraindicated.

  5. Insertion of Self-Expandable Nitinol Stents Without Previous Balloon Angioplasty Reduces Restenosis Compared with PTA Prior to Stenting

    SciTech Connect

    Harnek, Jan; Zoucas, Evita; Stenram, Unne; Cwikiel, Wojciech

    2002-10-15

    Purpose: To compare the development of intimal hyperplasia after deployment of a self-expanding nitinol stent with and without previous percutaneous transluminal balloon angioplasty (PTA), with the results after PTA alone. Methods: In nine healthy pigs, the iliac arteries were divided into three groups: group 1 (n = 6 arteries) was treated with PTA; group 2 n 6)with insertion of self-expanding stents after PTA; and group 3 (n = 6) with stent insertion without previous PTA. After 8 weeks the vessels were examined with intravascular ultrasonography,histologic examination and morphometric analysis. Results: Although the injury index in group 1 (0.17{+-} 0.57) was lower (p <0.05) than in group 2 (0.26 {+-} 0.06) and group 3 (0.26 {+-} 0.08), PTA-treated arteries showed significantly (p <0.05) reduced mean luminal gain (0.53 {+-} 2.84) compared with arteries treated with PTA prior to stenting (2.58 {+-} 1.38) and compared with stenting alone (4.65 {+-}5.34). Stenting after PTA resulted in a higher (p<0.05) restenosis index (2.63 {+-} 1.06) compared with stenting without PTA (1.35 {+-} 0.59). Group 2 also had a significantly thicker intimap <0.05) and 83% and 74% higher intima/mediaratio (p <0.05) compared with groups 1 and 3, respectively. Conclusion: Insertion of a self-expandable nitinol stent without previous PTA results in less intimalhyperplasia than if PTA is performed prior to stenting, suggesting that direct stenting can be used in angioplasty sessions with a favorable outcome.

  6. Radial forces of stents used in thoracic endovascular aortic repair and bare self-expanding nitinol stents measured ex vivo - Rapid rescue for obstruction of the innominate artery using bare self-expanding nitinol stents.

    PubMed

    Matsumoto, Takuya; Inoue, Kentaro; Tanaka, Shinichi; Aoyagi, Yukihiko; Matsubara, Yutaka; Matsuda, Daisuke; Yoshiya, Keiji; Yoshiga, Ryosuke; Ohkusa, Tomoko; Maehara, Yoshihiko

    2017-02-01

    Purpose Our objective was to compare the radial forces of several stents ex vivo to identify stents suitable for rescue of the unexpected coverage of aortic arch branches in thoracic endovascular aortic repair. Methods We measured the radial forces of two types of self-expanding bare nitinol stents (E-luminexx and Epic) used singly or as double-walled pairs, and of three endoprostheses used in thoracic endovascular aortic repair (TEVAR, Gore c-TAG, Relay, and Valiant) by compressing the stent using an MTS Instron universal testing machine (model #5582). We also examined the compressive effects of the TEVAR endoprostheses and the bare nitinol stents on each other. Results The radial force was greater in the center than at the edge of each stent. In all stents tested, the radial force decreased incrementally with increasing stent diameter. The radial force at the center was two times greater when using two stents than with a single stent. In the compression test, only E-luminexx used as a pair was not compressed after compressing a Relay endoprosthesis by 12 mm. Conclusion Two E-luminexx stents are appropriate to restore the blood flow if a TEVAR endoprosthesis covers the innominate artery following innominate-carotid-left subclavian arterial bypass.

  7. Feasibility study for the investigation of Nitinol self-expanding stents by neutron techniques

    NASA Astrophysics Data System (ADS)

    Rogante, M.; Pasquini, U.; Rosta, L.; Lebedev, V.

    2011-02-01

    In this paper, neutron techniques - in particular, small angle neutron scattering (SANS) and neutron diffraction (ND) - are considered for the non-destructive characterization of Nitinol artery stents. This roughly equiatomic (50Ni-50Ti at%) shape memory alloy (SMA) exhibits significant properties of superelasticity and biocompatibility that make it suitable to be typically used as smart material for medical implants and devices. Nitinol self-expanding artery stents, as permanent vascular support structures, supply an ideal option to bypass surgery, but they are submitted for the whole of patient's life to the dynamical stress of the artery pulsation and the aggression from the biological environment. These stents, consequently, can suffer from wear and fracture occurrence likely due to a variety of cyclic fatigue, overload conditions and residual stresses. Neutrons have recently become a progressively more important probe for various materials and components and they allow achieving information complementary to those obtained from the traditional microstructural analyses. The outputs from the preliminary works already carried out in this field consent to consider neutron techniques capable to contribute to the development of these crucial medical implants. The achievable results can yield trends adoptable in monitoring of the stent features.

  8. ALD mediated heparin grafting on nitinol for self-expanded carotid stents.

    PubMed

    Wang, Fei; Zhang, Yan; Chen, Xiumian; Leng, Bing; Guo, Xin; Zhang, Tao

    2016-07-01

    Carotid-artery atherosclerosis is a common cause of ischemic stroke. Carotid-artery stenting (CAS) is one of the most effective treatments. However, In-stent restenosis (ISR) and re-endothelialization delay are two major issues of intravascular stent which affect clinical safety and reduce effects. In this study, atomic layer deposition (ALD) technology was applied to deposit a layer (10nm) of Al2O3 on Nitinol surface as an intermediate functional layer. The alumina covered surface was then modified with a coupling agent 3-aminopropyltriethoxysilane (APS) and heparin sequentially in order to improve the hemocompatibility of Nitinol stents. The successful graft of APS and heparin onto Nitinol was proven by X-ray photoelectron spectroscopy. Furthermore, the predicted improvement in the biocompatibilities of modified Nitinol was confirmed by water contact angle measurement, protein adsorption, platelet adhesion, and plasma recalcification time determination. The results of hemolysis assay, cell proliferation and cytotoxicity tests revealed that the grafting of heparin on NiTi kept the original positive performance of nitinol material. The results indicate that ALD technology is of great potential for the manufacture of medical devices, especially for surface modifications and functionalization. ALD technology can help with modifications of inert metallic surfaces and therefore benefit implantable medical devices, especially intravascular stents.

  9. Bronchobiliary Fistula Treated by Self-expanding ePTFE-Covered Nitinol Stent-Graft

    SciTech Connect

    Gandini, Roberto; Konda, Daniel Tisone, Giuseppe; Pipitone, Vincenzo; Anselmo, Alessandro; Simonetti, Giovanni

    2005-12-15

    A 71-year-old man, who had undergone right hepatectomy extended to the caudate lobe with terminolateral Roux-en-Y left hepatojejunostomy for a Klatskin tumor, developed bilioptysis 3 weeks postoperatively due to bronchobiliary fistula. Percutaneous transhepatic cholangiography revealed a non-dilated biliary system with contrast medium extravasation to the right subphrenic space through a resected anomalous right posterior segmental duct. After initial unsuccessful internal-external biliary drainage, the fistula was sealed with a VIATORR covered self-expanding nitinol stent-graft placed with its distal uncovered region in the hepatojejunal anastomosis and the proximal ePTFE-lined region in the left hepatic duct. A 10-month follow-up revealed no recurrence of bilioptysis and confirmed the complete exclusion of the bronchobiliary fistula.

  10. Endovascular Repair of Arterial Iliac Vessel Wall Lesions with a Self-Expandable Nitinol Stent Graft System

    PubMed Central

    Mensel, Birger; Kühn, Jens-Peter; Hoene, Andreas; Hosten, Norbert; Puls, Ralf

    2014-01-01

    Objective To assess the therapeutic outcome after endovascular repair of iliac arterial lesions (IALs) using a self-expandable Nitinol stent graft system. Methods Between July 2006 and March 2013, 16 patients (13 males, mean age: 68 years) with a self-expandable Nitinol stent graft. A total of 19 lesions were treated: nine true aneurysms, two anastomotic aneurysms, two dissections, one arteriovenous fistula, two type 1B endoleaks after endovascular aneurysm repair, one pseudoaneurysm, and two perforations after angioplasty. Pre-, intra-, and postinterventional imaging studies and the medical records were analyzed for technical and clinical success and postinterventional complications. Results The primary technical and clinical success rate was 81.3% (13/16 patients) and 75.0% (12/16), respectively. Two patients had technical failure due to persistent type 1A endoleak and another patient due to acute stent graft thrombosis. One patient showed severe stent graft kinking on the first postinterventional day. In two patients, a second intervention was performed. The secondary technical and clinical success rate was 87.5% (14/16) and 93.8% (15/16). The minor complication rate was 6.3% (patient with painful hematoma at the access site). The major complication rate was 6.3% (patient with ipsilateral deep vein thrombosis). During median follow-up of 22.4 months, an infection of the aneurysm sac in one patient and a stent graft thrombosis in another patient were observed. Conclusion Endovascular repair of various IALs with a self-expandable Nitinol stent graft is safe and effective. PMID:25119346

  11. Nitinol stent design - understanding axial buckling.

    PubMed

    McGrath, D J; O'Brien, B; Bruzzi, M; McHugh, P E

    2014-12-01

    Nitinol׳s superelastic properties permit self-expanding stents to be crimped without plastic deformation, but its nonlinear properties can contribute towards stent buckling. This study investigates the axial buckling of a prototype tracheobronchial nitinol stent design during crimping, with the objective of eliminating buckling from the design. To capture the stent buckling mechanism a computational model of a radial force test is simulated, where small geometric defects are introduced to remove symmetry and allow buckling to occur. With the buckling mechanism ascertained, a sensitivity study is carried out to examine the effect that the transitional plateau region of the nitinol loading curve has on stent stability. Results of this analysis are then used to redesign the stent and remove buckling. It is found that the transitional plateau region can have a significant effect on the stability of a stent during crimping, and by reducing the amount of transitional material within the stent hinges during loading the stability of a nitinol stent can be increased.

  12. The New Nitinol Conformable Self-Expandable Metal Stents for Malignant Colonic Obstruction: A Pilot Experience as Bridge to Surgery Treatment

    PubMed Central

    2014-01-01

    Introduction. Self-expandable metal stents (SEMS) are a nonsurgical option for treatment of malignant colorectal obstruction also as a bridge to surgery approach. The new nitinol conformable stent has improved clinical outcomes in these kinds of patients. We report a pilot experience with nitinol conformable SEMS placement as bridge to surgery treatment in patients with colorectal obstruction. Materials and Methods. Between April and August 2012, we collected data on colonic nitinol conformable SEMS placement in a cohort of consecutive symptomatic patients, with malignant colorectal obstruction, who were treated as a bridge to surgery. Technical success, clinical success, and adverse events were recorded. Results. Ten patients (7 male (70%)), with a mean age of 69.2 ± 10.1, were evaluated. The mean length of the stenosis was 3.6 ± 0.6 cm. Five patients (50%) were treated on an emergency basis. The median time from stent placement to surgery was 16 days (interquartile range 7–21). Technical and clinical success was achieved in all patients with a significant early improvement of symptoms. No adverse events due to the SEMS placement were observed. Conclusion. This pilot study confirmed the important role of nitinol conformable SEMS as a bridge to surgery option in the treatment of symptomatic malignant colorectal obstruction. PMID:24526914

  13. Successful Endovascular Repair of an Iatrogenic Perforation of the Superficial Femoral Artery Using Self-Expanding Nitinol Supera Stents in a Patient with Acute Thromboembolic Limb Ischemia.

    PubMed

    Eisele, Tom; Muenz, Benedikt M; Korosoglou, Grigorios

    2016-01-01

    The treatment of acute thromboembolic limb ischemia includes well-established surgical thrombectomy procedures and, in recent times, also percutaneous rotational thrombectomy using Straub Rotarex® system. This modality not only enables efficient treatment of such thrombotic occlusion but also in rare cases may imply the risk of perforation of the occluded artery. Herein, we report the case of a perforation of the superficial femoral artery (SFA) in an elderly female patient with thromboembolic limb ischemia. The perforation was successfully treated by implantation of self-expanding nitinol Supera stents and without the need for implantation of a stent graft.

  14. Successful Endovascular Repair of an Iatrogenic Perforation of the Superficial Femoral Artery Using Self-Expanding Nitinol Supera Stents in a Patient with Acute Thromboembolic Limb Ischemia

    PubMed Central

    Eisele, Tom; Muenz, Benedikt M.

    2016-01-01

    The treatment of acute thromboembolic limb ischemia includes well-established surgical thrombectomy procedures and, in recent times, also percutaneous rotational thrombectomy using Straub Rotarex® system. This modality not only enables efficient treatment of such thrombotic occlusion but also in rare cases may imply the risk of perforation of the occluded artery. Herein, we report the case of a perforation of the superficial femoral artery (SFA) in an elderly female patient with thromboembolic limb ischemia. The perforation was successfully treated by implantation of self-expanding nitinol Supera stents and without the need for implantation of a stent graft. PMID:27213074

  15. Thin film nitinol covered stents: design and animal testing.

    PubMed

    Levi, Daniel S; Williams, Ryan J; Liu, Jasen; Danon, Saar; Stepan, Lenka L; Panduranga, Mohanchandra K; Fishbein, Michael C; Carman, Greg P

    2008-01-01

    Interventionalists in many specialties have the need for improved, low profile covered stents. Thin films of nitinol (<5-10 microns) could be used to improve current covered stent technology. A "hot target" sputter deposition technique was used to create thin films of nitinol for this study. Covered stents were created from commercially available balloon-inflatable and self-expanding stents. Stents were deployed in a laboratory flow loop and in four swine. Uncovered stent portions served as controls. Postmortem examinations were performed 2-6 weeks after implantation. In short-term testing, thin film nitinol covered stents deployed in the arterial circulation showed no intimal proliferation and were easily removed from the arterial wall postmortem. Scanning electron microscopy showed a thin layer of endothelial cells on the thin film, which covered the entire film by 3 weeks. By contrast, significant neointimal hyperplasia occurred on the luminal side of stents deployed in the venous circulation. Extremely low-profile covered stents can be manufactured using thin films of nitinol. Although long-term studies are needed, thin film nitinol may allow for the development of low-profile, nonthrombogenic covered stents.

  16. Nitinol Esophageal Stents: New Designs and Clinical Indications

    SciTech Connect

    Strecker, Ernst-Peter; Boos, Irene; Vetter, Sylvia; Strohm, Michael; Domschke, Sigurd

    1996-11-15

    Purpose: To evaluate the clinical use of covered and noncovered, knitted nitinol stents in patients presenting new stent indications. Methods: Self-expandable, knitted nitinol stents were implanted in four patients for treatment of dysphagia. In two patients who had malignant strictures and had esophago-respiratory fistulae and in one patient with an esophagocutaneous fistula, polytetrafluoroethylene (PTFE)-covered stents were implanted. One patient received a noncovered stent, but a retrograde approach through a percutaneous endoscopic gastrostomy (PEG) fistula had to be chosen for recanalization of an esophageal occlusion. Two patients received stents for treatment of benign strictures. Results: Recanalization of the stricture and stent implantation were performed under fluoroscopic control without any procedure-related morbidity or mortality. Dysphagia improved in all patients and the esophageal fistulae could be sealed off by covered stents. During a maximum follow-up of 18 months, there was no stent migration or esophageal perforation. Complications observed were stent stenosis due to food impaction (1/4) and benign stent stenosis (2/2). Most complications could be treated by the interventional radiologist. Conclusion: Self-expandable, covered Nitinol stents provide an option for the treatment of dysphagia combined with esophageal fistulae. In combination with interventional radiology techniques, even complex strictures are accessible. For benign strictures, the value of stent treatment has not yet been proven.

  17. On the role of SMA modeling in simulating NiTinol self-expanding stenting surgeries to assess the performance characteristics of mechanical and thermal activation schemes.

    PubMed

    Saleeb, A F; Dhakal, B; Owusu-Danquah, J S

    2015-09-01

    The work is focused on a detailed simulation of the key stages involved in the NiTinol self-expanding stenting surgical procedure; i.e., crimping, deployment, SMA activation, as well as post-surgery steady-state cyclic behavior mimicking the systolic-to-diastolic pressure oscillations. To this end, a general multi-mechanism SMA model was utilized, whose calibration was completed using the test data from simple isothermal uniaxial tension experiments. The emphasis in the study was placed on the comparison of two alternative SMA activation protocols, in terms of both the immediate and long-term (post-surgery) performance characteristics. The first is 'hard' mechanical activation utilizing superelasticity, and the second is 'soft' thermal activation relying upon the combined one-way shape memory effect and constrained-recovery characteristics of the NiTinol material. The important findings are (1) the thermal activation protocol is far superior compared to the mechanical counterpart, from the point of view of lower magnitudes of the induced outward chronic forces, lesser developed stresses in the host tissue, as well as higher compression ratio with lesser crimping force for the same geometry of initial stent memory configuration, (2) the thermal activation protocol completely bypassed the complications of maintaining the high restraining force during deployment of the stent, and (3) there is no indication of any detrimental functional fatigue/degradation in the cured stenotic artery during cyclic pressure oscillations.

  18. Late Stent Expansion and Neointimal Proliferation of Oversized Nitinol Stents in Peripheral Arteries

    SciTech Connect

    Zhao, Hugh Q. Nikanorov, Alexander; Virmani, Renu; Jones, Russell; Pacheco, Erica; Schwartz, Lewis B.

    2009-07-15

    For peripheral endovascular intervention, self-expanding (SE) stents are commonly oversized in relation to target arteries to assure optimal wall apposition and prevent migration. However, the consequences of oversizing have not been well studied. The purpose of this study was to examine the effects of SE stent oversizing (OS) with respect to the kinetics of late stent expansion and the long-term histological effects of OS. Pairs of overlapped 8 x 28-mm Nitinol SE stents were implanted into the iliofemoral arteries of 14 Yucatan swine. Due to variations in target artery size, the stent-to-artery ratio ranged from 1.2:1 to 1.9:1. Lumen and stent diameters were assessed by quantitative angiography at the time of implantation. Following angiographic assessment at 6 months, stented arteries were perfusion-fixed, sectioned, and stained for histological analysis. Immediately following implantation, the stents were found to be expanded to a range of 4.7-7.1 mm, largely conforming to the diameter of the recipient target artery. The stents continued to expand over time, however, and all stents had enlarged to nearly their 8-mm nominal diameter by 6 months. The histological effects of OS were profound, with marked increases in injury and luminal area stenosis, including a statistically significant linear correlation between stent-to-artery ratio and area stenosis. In this experimental model of peripheral endovascular intervention, oversized Nitinol SE stents are constrained by their target artery diameter upon implantation but expand to their nominal diameter within 6 months. Severe OS (stent-to-artery ratio >1.4:1) results in a profound long-term histological response including exuberant neointimal proliferation and luminal stenosis.

  19. Point-of-care seeding of nitinol stents with blood-derived endothelial cells.

    PubMed

    Jantzen, Alexandra E; Noviani, Maria; Mills, James S; Baker, Katherine M; Lin, Fu-Hsiung; Truskey, George A; Achneck, Hardean E

    2016-11-01

    Nitinol-based vascular devices, for example, peripheral and intracranial stents, are limited by thrombosis and restenosis. To ameliorate these complications, we developed a technology to promote vessel healing by rapidly seeding (QuickSeeding) autologous blood-derived endothelial cells (ECs) onto modified self-expanding nitinol stent delivery systems immediately before implantation. Several thousand micropores were laser-drilled into a delivery system sheath surrounding a commercial nitinol stent to allow for exit of an infused cell suspension. As suspension medium flowed outward through the micropores, ECs flowed through the delivery system attaching to the stent surface. The QuickSeeded ECs adhered to and spread on the stent surface following 24-h in vitro culture under static or flow conditions. Further, QuickSeeded ECs on stents that were deployed into porcine carotid arteries spread to endothelialize stent struts within 48 h (n = 4). The QuickSeeded stent struts produced significantly more nitric oxide in ex vivo flow circuits after 24 h, as compared to static conditions (n = 5). In conclusion, ECs QuickSeeded onto commercial nitinol stents within minutes of implantation spread to form a functional layer in vitro and in vivo, providing proof of concept that the novel QuickSeeding method with modified delivery systems can be used to seed functional autologous endothelium at the point of care. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1658-1665, 2016.

  20. Computational Study of Axial Fatigue for Peripheral Nitinol Stents

    NASA Astrophysics Data System (ADS)

    Meoli, Alessio; Dordoni, Elena; Petrini, Lorenza; Migliavacca, Francesco; Dubini, Gabriele; Pennati, Giancarlo

    2014-07-01

    Despite their success as primary treatment for vascular diseases, Nitinol peripheral stents are still affected by complications related to fatigue failure. Hip and knee movements during daily activities produce large and cyclic deformations of the superficial femoral artery, that concomitant to the effects of pulsatile blood pressure, may cause fatigue failure in the stent. Fatigue failure typically occurs in cases of very extended lesions, which often require the use of two or more overlapping stents. In this study, finite element models were used to study the fatigue behavior of Nitinol stents when subjected to cyclic axial compression in different conditions. A specific commercial Nitinol stent was chosen for the analysis and subjected to cyclic axial compression typical of the femoral vascular region. Three different configurations were investigated: stent alone, stent deployed in a tube, and two overlapping stents deployed in a tube. Results confirm that stent oversizing has an influence in determining both the mean and amplitude strains induced in the stent and plays an important role in determining the fatigue response of Nitinol stents. In case of overlapping stents, numerical results suggest higher amplitude strains concentrate in the region close to the overlapping portion where the abrupt change in stiffness causes higher cyclic compression. These findings help to explain the high incidence of stent fractures observed in various clinical trials located close to the overlapping portion.

  1. [Finite Element Analysis of Effect of Key Dimension of Nitinol Stent on Its Fatigue Behaviour].

    PubMed

    Li, Jianjun; Wang, Shengzhang

    2015-04-01

    To evaluate the fatigue behavior of nitinol stents, we used the finite element method to simulate the manufacture processes of nitinol stents, including expanding, annealing, crimping, and releasing procedure in applications of the clinical treatments. Meanwhile, we also studied the effect of the crown area dimension of stent on strain distribution. We then applied a fatigue diagram to investigate the fatigue characteristics of nitinol stents. The results showed that the maximum strain of all three stent structures, which had different crown area dimensions under vessel loads, located at the transition area between the crown and the strut, but comparable deformation appeared at the inner side of the crown area center. The cause, of these results was that the difference of the area moment of inertia determined by the crown dimension induced the difference of strain distribution in stent structure. Moreover, it can be drawn from the fatigue diagrams that the fatigue performance got the best result when the crown area dimension equaled to the intermediate value. The above results proved that the fatigue property of nitinol stent had a close relationship with the dimension of stent crown area, but there was no positive correlation.

  2. [Numerical modeling of shape memory alloy vascular stent's self-expandable progress and "optimized grid" of stent].

    PubMed

    Xu, Qiang; Liu, Yulan; Wang, Biao; He, Jin

    2008-10-01

    Vascular stent is an important medical appliance for angiocardiopathy. Its key deformation process is the expandable progress of stent in the vessel. The important deformation behaviour corresponds to two mechanics targets: deformation and stress. This paper is devoted to the research and development of vascular stent with proprietary intellectual property rights. The design of NiTinol self-expandable stent is optimized by means of finite element software. ANSYS is used to build the finite element simulation model of vascular stent; the molding material is NiTinol shape memory alloy. To cope with the factors that affect the structure of stent, the shape of grid and so on, the self-expanding process of Nitinol stent is simulated through computer. By making a comparison between two kinds of stents with similar grid structure, we present a new concept of "Optimized Grid" of stent.

  3. On the Mechanical Properties and Microstructure of Nitinol forBiomedical Stent Applications

    SciTech Connect

    Robertson, Scott W.

    2006-01-01

    This dissertation was motivated by the alarming number of biomedical device failures reported in the literature, coupled with the growing trend towards the use of Nitinol for endovascular stents. The research is aimed at addressing two of the primary failure modes in Nitinol endovascular stents: fatigue-crack growth and overload fracture. The small dimensions of stents, coupled with their complex geometries and variability among manufacturers, make it virtually impossible to determine generic material constants associated with specific devices. Instead, the research utilizes a hybrid of standard test techniques (fracture mechanics and x-ray micro-diffraction) and custom-designed testing apparatus for the determination of the fracture properties of specimens that are suitable representations of self-expanding Nitinol stents. Specifically, the role of texture (crystallographic alignment of atoms) and the austenite-to-martensite phase transformation on the propagation of cracks in Nitinol was evaluated under simulated body conditions and over a multitude of stresses and strains. The results determined through this research were then used to create conservative safe operating and inspection criteria to be used by the biomedical community for the determination of specific device vulnerability to failure by fracture and/or fatigue.

  4. Corrosion resistance of polyurethane-coated nitinol cardiovascular stents.

    PubMed

    Mazumder, M M; De, S; Trigwell, S; Ali, N; Mazumder, M K; Mehta, J L

    2003-01-01

    Corrosion of metal stents implanted inside an artery can have two adverse effects: (1) tissue reaction and possible toxic effects from the metal ions leaching out of the stent, and (2) loss of mechanical strength of the stent caused by corrosion. The corrosion resistance of Nitinol (Nickel-Titanium) stents and its modulation with different film thickness of polymer coating was studied against an artificial physiological solution using a Potentiostat/Galvanostat and an electrochemical corrosion cell. The corrosion rate decreased rapidly from 275 microm/year for an uncoated surface down to less than 13 microm/year for a 30 microm thick polyurethane coating. Stainless steel (316L) and Nitinol both contain potentially toxic elements, and both are subject to stress corrosion. Minimization of corrosion can significantly reduce both tissue reaction and structural degradation.

  5. Neointimal Hyperplasia in Low-Profile Nitinol Stents, Palmaz Stents, and Wallstents: A Comparative Experimental Study

    SciTech Connect

    Schuermann, Karl; Vorwerk, Dierk; Kulisch, Arthur; Stroehmer-Kulisch, Eva; Biesterfeld, Stefan; Stopinski, Tadeusz; Guenther, Rolf W.

    1996-04-15

    Purpose: To compare neointima formation following insertion of low-profile Nitinol stents, Palmaz stents, and Wallstents. Methods: Nitinol stents, Palmaz stents, and Wallstents similar in size were transfemorally inserted into the iliac arteries of 12 sheep. Four stents per sheep were deployed; the position of the stents was varied so that each type of stent was placed in each position (right or left, proximal or distal) with equal frequency. Stent patency was followed by angiography. Six sheep were euthanized after 1 month, and the remaining six after 6 months. Iliac arteries were removed en bloc and prepared for histological examination. Neointimal and medial thickness were measured by light microscopy, and measurements were analyzed statistically. Results: Mean neointimal thickness both over (NO) and between (NB) the stent struts was greater in Wallstents (NO = 0.341 mm, NB = 0.368 mm) than in the Nitinol (NO = 0.260 mm, NB = 0.220 mm) and Palmaz stents (NO = 0.199 mm, NB = 0.204 mm), but differences were not significant (p> 0.05). Medial atrophy in the area between the stent struts was greater in Wallstents compared with Nitinol and Palmaz stents (p < 0.007 and p < 0.02, respectively); in the area under the stent struts there was a significant difference only between Palmaz stents and Wallstents (p < 0.02). Conclusion: Under defined experimental conditions, none of the three types of stent appears to be preferable to the others regarding neointima formation in the short- to mid-term follow-up period.

  6. Successful Exclusion of Subclavian Aneurysms with Covered Nitinol Stents

    SciTech Connect

    Szeimies, Ulrike; Kueffer, Georg; Stoeckelhuber, Beate; Steckmeier, Bernd

    1998-05-15

    Two cases of percutaneous endoluminal exclusion of a subclavian aneurysm with a Dacron-coated nitinol stent are presented. One subclavian aneurysm followed trauma; the other was due to thoracic outlet stenosis which was caused by a cervical rib. In both patients the aneurysm was excluded successfully. The follow-up periods were 22 and 14 months, respectively. Stenoses at the stent graft occurred in both patients; one was treated by balloon angioplasty. In selected patients, endoluminal grafting could be an alternative to surgery; however, stent graft designs need to be improved and long-term follow-up is awaited.

  7. Percutaneous Palliation of Pancreatic Head Cancer: Randomized Comparison of ePTFE/FEP-Covered Versus Uncovered Nitinol Biliary Stents

    SciTech Connect

    Krokidis, Miltiadis; Fanelli, Fabrizio; Orgera, Gianluigi; Tsetis, Dimitrios; Mouzas, Ioannis; Bezzi, Mario; Kouroumalis, Elias; Pasariello, Roberto; Hatzidakis, Adam

    2011-04-15

    The purpose of this study was to compare the clinical effectiveness of expanded polytetrafluoroethylene/fluorinated-ethylene-propylene (ePTFE/FEP)-covered stents with that of uncovered nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer. Eighty patients were enrolled in a prospective randomized study. Bare nitinol stents were used in half of the patients, and ePTFE/FEP-covered stents were used in the remaining patients. Patency, survival, complications, and mean cost were calculated in both groups. Mean patency was 166.0 {+-} 13.11 days for the bare-stent group and 234.0 {+-} 20.87 days for the covered-stent group (p = 0.007). Primary patency rates at 3, 6, and 12 months were 77.5, 69.8, and 69.8% for the bare-stent group and 97.5, 92.2, and 87.6% for the covered-stent group, respectively. Mean secondary patency was 123.7 {+-} 22.5 days for the bare-stent group and 130.3 {+-} 21.4 days for the covered-stent group. Tumour ingrowth occurred exclusively in the bare-stent group in 27.5% of cases (p = 0.002). Median survival was 203.2 {+-} 11.8 days for the bare-stent group and 247.0 {+-} 20 days for the covered-stent group (p = 0.06). Complications and mean cost were similar in both groups. Regarding primary patency and ingrowth rate, ePTFE/FEP-covered stents have shown to be significantly superior to bare nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer and pose comparable cost and complications. Use of a covered stent does not significantly influence overall survival rate; nevertheless, the covered endoprosthesis seems to offer result in fewer reinterventions and better quality of patient life.

  8. Contralateral approach to iliac artery recanalization with kissing nitinol stents present in the aortic bifurcation.

    PubMed

    Joseph, George; Hooda, Amit; Thomson, Viji Samuel

    2015-01-01

    A 69-year-old man, who had earlier undergone reconstruction of the aortic bifurcation with kissing nitinol stents, presented with occlusion of the left external iliac artery. The occlusion was successfully and safely recanalized using contralateral femoral approach with passage of interventional hardware through the struts of the stents in the aortic bifurcation. Presence of contemporary flexible nitinol stents with open-cell design in the aortic bifurcation is not a contraindication to the use of the contralateral femoral approach.

  9. Treatment of a Ruptured Anastomotic Esophageal Stricture Following Bougienage with a Dacron-Covered Nitinol Stent

    SciTech Connect

    Heindel, Walter; Gossmann, Axel; Fischbach, Roman; Michel, Olaf; Lackner, Klaus

    1996-11-15

    A patient suffering from esophagorespiratory fistula after bougienage of a benign stricture at the site of the anastomosis between a jejunal interposition and the esophagus was referred for interventional treatment. A prototype nitinol stent centrally covered with Dacron was implanted under regional anesthesia and fluoroscopic guidance. The self-expanding prosthesis dilated the stenosis completely and closed the fistula, with consequent improvement in respiratory and nutritional status and thus the general quality of life. The patient was able to eat and drink normally until death 3 months later due to progression of his underlying malignant disease.

  10. Effects of Crimping on Mechanical Performance of Nitinol Stent Designed for Femoral Artery: Finite Element Analysis

    NASA Astrophysics Data System (ADS)

    Nematzadeh, F.; Sadrnezhaad, S. K.

    2013-11-01

    Nitinol stents are used to minimize improper dynamic behavior, low twistability, and inadequate radial mechanical strength of femoral artery stents. In this study, finite element method is used to investigate the effect of crimping and Austenite finish temperature ( A f) of Nitinol on mechanical performance of Z-shaped open-cell femoral stent under crimping conditions. Results show that low A f Nitinol has better mechanical and clinical performance due to small chronic outward force, large radial resistive force, and appropriate superelastic behavior.

  11. Finite element modeling of a progressively expanding shape memory stent.

    PubMed

    Thériault, Philippe; Terriault, Patrick; Brailovski, Vladimir; Gallo, Richard

    2006-01-01

    Cardiovascular stents are small cylindrical devices introduced in stenosed arteries to reopen the lumen and restore blood flow. However, this treatment presents complications, including restenosis, which is the reclosing of the artery's diameter after the insertion of a stent. The structure of the prosthesis penetrates into and injures the walls of the patient's artery. There then follows a proliferation of cells and the formation of scar tissue around the injury, similar to the scarring of other organic tissues. This reaction to the trauma subjects the artery to close. The proposed solution is to develop a Nitinol stent with a progressive expansion device made of polyethylene, allowing smooth and gradual contact between the stent and the artery's wall by creep effect. The purpose of this paper is to describe the technology and methodology for the numerical study of this kind of stent through the finite element method. ANSYS 8.0 software is used to perform the analysis. The Nitinol is modeled with a superelastic law and the polyethylene with a yield hardening law. A first simulation determines the final geometry of the stent laser cut from a small tube. A second simulation examines the behavior of the prosthesis during surgery and over the 4 weeks following the operation. The results demonstrate that a compromise can be reached between a limited expansion prior the inflation of the expandable balloon and a significant expansion by creep of the polymer rings.

  12. Effects of heat treatment on shape-setting and non-linearmechanical properties of Nitinol stent

    NASA Astrophysics Data System (ADS)

    Liu, Xiaopeng; Wang, Yinong; Qi, Min; Yang, Dazhi

    2007-07-01

    NiTi shape memory alloy is a temperature sensitive material with non-linear mechanical properties and good biocompatibility, which can be used for medical devices such as stent, catheter guide wire and orthodontic wire. The majority of nitinol stents are of the self-expanding type basing on the superelasticity. Nitinol stents are shape set into the open condition and compressed and inserted into the delivery catheter. Additional the shape-setting treatment can be used as a tool to accurately tune the transformation temperatures and mechanical properties. In this study, different heat treatments have been performed on the Ti-50.7at%Ni alloy wires. And results of shape-setting, austenite transformation finish temperature and non-linear mechanical property of NiTi shape memory alloy at body temperature have been investigated. The experimental results show that the proper shape-setting temperature should be chosen between 450-550 °C. And the shape-setting results were stabilization when the NiTi wires were constrain-treated at 500 and 550°C and ageing time longer than 10 minutes. The austenite finish temperatures increased with ageing time and increased first and then decreased with ageing temperature. The peak values were obtained at 400°C. When the heat treatments was performed at the same temperature, both the upper plateau stresses and lower plateau stresses decreased with the ageing time. Most of treated nitinol wires owned good recovery ability at body temperature and the permanent sets were less than 0.05% when short time ageing treatment was performed at 500°C.

  13. Nitinol stents in the treatment of benign proximal tracheal stenosis or tracheomalacia.

    PubMed

    Isa, A Y; Macandie, C; Irvine, B W

    2006-01-01

    Nitinol stents have been used in the treatment of benign tracheal stenosis. A retrospective review of five patients treated at Stobhill Hospital over the last six and a half years is presented. Age at presentation ranged from 17 to 76 years. The minimum follow-up period was 23 months and the maximum was 78 months. All our patients were successfully decannulated, with none requiring recannulation. Four patients developed granulation tissue related to the stent at intervals ranging from three weeks to 41 months post stenting. Topical mitomycin C application has been useful after resection of granulations using the carbon dioxide (CO2) laser. Stent migration occurred in one patient three weeks after insertion. Nitinol stents are easy to insert and effective in the treatment of tracheal stenosis, but can have associated morbidity. Their use should be considered carefully, as insertion should be regarded as permanent. Publications reporting experience and outcome with the use of Nitinol stents in the trachea are reviewed.

  14. Double-Layered PTFE-Covered Nitinol Stents: Experience in 32 Patients with Malignant Esophageal Strictures

    SciTech Connect

    Park, Jung Gu; Jung, Gyoo-Sik Oh, Kyung Seung; Park, Seon-Ja

    2010-08-15

    We evaluated the effectiveness of a double-layered polytetrafluoroethylene (PTFE)-covered nitinol stent in the palliative treatment of malignant esophageal strictures. A double-layered PTFE-covered nitinol stent was designed to reduce the propensity to migration of conventional covered stent. The stent consists of an inner PTFE-covered stent and an outer uncovered nitinol stent tube. With fluoroscopic guidance, the stent was placed in 32 consecutive patients with malignant esophageal strictures. During the follow-up period, the technical and clinical success rates, complications, and cumulative patient survival and stent patency were evaluated. Stent placement was technically successful in all patients, and no procedural complications occurred. After stent placement, the symptoms of 30 patients (94%) showed improvement. During the mean follow-up of 103 days (range, 9-348 days), 11 (34%) of 32 patients developed recurrent symptoms due to tumor overgrowth in five patients (16%), tumor ingrowth owing to detachment of the covering material (PTFE) apart from the stent wire in 3 (9%), mucosal hyperplasia in 2 (6%), and stent migration in 1 (3%). Ten of these 11 patients were treated by means of placing a second covered stent. Thirty patients died, 29 as a result of disease progression and 1 from aspiration pneumonia. The median survival period was 92 days. The median period of primary stent patency was 190 days. The double-layered PTFE-covered nitinol stent seems to be effective for the palliative treatment of malignant esophageal strictures. We believe that the double-layer configuration of this stent can contribute to decreasing the stent's migration rate.

  15. Nitinol Stent Oversizing in Patients Undergoing Popliteal Artery Revascularization: A Finite Element Study.

    PubMed

    Gökgöl, Can; Diehm, Nicolas; Nezami, Farhad Rikhtegar; Büchler, Philippe

    2015-12-01

    Nitinol stent oversizing is frequently performed in peripheral arteries to ensure a desirable lumen gain. However, the clinical effect of mis-sizing remains controversial. The goal of this study was to provide a better understanding of the structural and hemodynamic effects of Nitinol stent oversizing. Five patient-specific numerical models of non-calcified popliteal arteries were developed to simulate the deployment of Nitinol stents with oversizing ratios ranging from 1.1 to 1.8. In addition to arterial biomechanics, computational fluid dynamics methods were adopted to simulate the physiological blood flow inside the stented arteries. Results showed that stent oversizing led to a limited increase in the acute lumen gain, albeit at the cost of a significant increase in arterial wall stresses. Furthermore, localized areas affected by low Wall Shear Stress increased with higher oversizing ratios. Stents were also negatively impacted by the procedure as their fatigue safety factors gradually decreased with oversizing. These adverse effects to both the artery walls and stents may create circumstances for restenosis. Although the ideal oversizing ratio is stent-specific, this study showed that Nitinol stent oversizing has a very small impact on the immediate lumen gain, which contradicts the clinical motivations of the procedure.

  16. Endovascular Treatment of a Giant Superior Mesenteric Artery Pseudoaneurysm Using a Nitinol Stent-Graft

    SciTech Connect

    Gandini, Roberto; Pipitone, Vincenzo; Konda, Daniel Pendenza, Gianluca; Spinelli, Alessio; Stefanini, Matteo; Simonetti, Giovanni

    2005-01-15

    A 68-year-old woman presenting with gastrointestinal bleeding (hematocrit 19.3%) and in a critical clinical condition (American Society of Anesthesiologists grade 4) from a giant superior mesenteric artery pseudoaneurysm (196.0 x 131.4 mm) underwent emergency endovascular treatment. The arterial tear supplying the pseudoaneurysm was excluded using a 5.0 mm diameter and 31 mm long monorail expanded polytetrafluoroethylene (ePTFE)-covered self-expanding nitinol stent. Within 6 days of the procedure, a gradual increase in hemoglobin levels and a prompt improvement in the clinical condition were observed. Multislice CT angiograms performed immediately, 5 days, 30 days and 3 months after the procedure confirmed the complete exclusion of the pseudoaneurysm.

  17. Endoscopic Removal of a Nitinol Mesh Stent from the Ureteropelvic Junction after 15 Years

    PubMed Central

    Smrkolj, Tomaž; Šalinović, Domagoj

    2015-01-01

    We report a rare case of a patient with a large stone encrusted on a nitinol mesh stent in the ureteropelvic junction. The stent was inserted in the year 2000 after failure of two pyeloplasty procedures performed due to symptomatic ureteropelvic junction stenosis. By combining minimally invasive urinary stone therapies—extracorporeal shock wave lithotripsy, semirigid ureterorenoscopy with laser lithotripsy, and percutaneous nephrolithotomy—it was possible to completely remove the encrusted stone and nitinol mesh stent that was implanted for 15 years, rendering the patient symptom and obstruction free. PMID:26697258

  18. A direct nitinol stent delivery technique for endovascular treatment: a sheath-less stenting technique.

    PubMed

    Shintani, Yoshiaki; Kawasaki, Tomohiro; Fujimura, Takashi; Ishida, Kouichirou; Higuchi, Takanori; Kajiwara, Masataka; Fukuoka, Ryota; Orita, Yoshiya; Umeji, Kyoko; Koga, Hisashi; Koga, Nobuhiko

    2015-04-01

    Access site problems often cause serious complications in endovascular treatment. The aim of this study is to investigate whether a sheath-less nitinol stenting technique leads to reduce access site complications. This study was a single-center retrospective analysis of a prospectively maintained database. The study enrolled consecutive 98 patients with 111 lesions undergoing provisional stenting for de novo iliac artery or femoro-popliteal artery stenosis between August 2010 and November 2011. The patients were divided into two groups, a conventional procedure group and a sheath-less procedure group. The outcomes of this study were peri-procedural access site complications, initial success rate, procedure time, hemostatic time and bed-rest time. Forty-four lesions in 39 patients that treated using the sheath-less nitinol stent delivery technique were compared with 67 lesions in 59 patients treated using the conventional procedure. All procedures were successful. The incidence of pseudoaneurysm was significantly lower in the sheath-less procedure group than in the conventional procedure group (p = 0.043). However, there were no significant differences in any other complications. No significant difference was observed in the procedural time (p = 0.309). However, hemostatic time and bed-rest time were significantly shorter in the sheath-less procedure than in the conventional procedure (p < 0.0001). A sheath-less stenting technique reduced the access site incidence of pseudoaneurysm and did not increase other access site complications. Besides, this technique shortened hemostatic time and bed-rest time. The sheath-less stenting technique is considered to be a useful method for endovascular treatment.

  19. Statistical characteristics of surface integrity by fiber laser cutting of Nitinol vascular stents

    NASA Astrophysics Data System (ADS)

    Fu, C. H.; Liu, J. F.; Guo, Andrew

    2015-10-01

    Nitinol alloys have been widely used in manufacturing of vascular stents due to the outstanding properties such as superelasticity, shape memory, and superior biocompatibility. Laser cutting is the dominant process for manufacturing Nitinol stents. Conventional laser cutting usually produces unsatisfactory surface integrity which has a significant detrimental impact on stent performance. Emerging as a competitive process, fiber laser with high beam quality is expected to produce much less thermal damage such as striation, dross, heat affected zone (HAZ), and recast layer. To understand the process capability of fiber laser cutting of Nitinol alloy, a design-of-experiment based laser cutting experiment was performed. The kerf geometry, roughness, topography, microstructure, and hardness were studied to better understand the nature of the HAZ and recast layer in fiber laser cutting. Moreover, effect size analysis was conducted to investigate the relationship between surface integrity and process parameters.

  20. Biomedical engineering in design and application of nitinol stents with shape memory effect

    NASA Astrophysics Data System (ADS)

    Ryklina, E. P.; Khmelevskaya, I. Y.; Morozova, Tamara V.; Prokoshkin, S. D.

    1996-04-01

    Our studies in the field of endosurgery in collaboration with the physicians of the National Research Center of Surgery of the Academy of Medical Sciences are carried out beginning in 1983. These studies laid the foundation for the new direction of X-ray surgery--X-ray Nitinol stenting of vessels and tubular structures. X-ray nitinol stents are unique self-fixing shells based on the shape memory effect and superelasticity of nickel-titanium alloys self- reconstructed under human body temperature. Applied for stenting of arteries in cases of stenosis etc., bile ducts in cases of benign and malignant stenoses, digestive tract in cases of oesophageal cancer and cervical canal uterus in cases of postsurgical atresiss and strictures of uterine. The purpose of stenting is restoration of the shape of artery or tubular structure by a cylinder frame formation. The especially elaborated original method of stenting allows to avoid the traditional surgical operation, i.e. the stenting is performed without blood, narcosis and surgical knife. The stent to be implanted is transported into the affected zone through the puncture under the X-ray control. Clinical applications of X-ray endovascular stenting has been started in March 1984. During this period nearly 400 operations on stenting have been performed on femoral, iliac, brachio-cephalic, subclavian arteries, bile ducts, tracheas, digestive tract and cervical canal uterus.

  1. Effects of Oxide Layer Composition and Radial Compression on Nickel Release in Nitinol Stents

    NASA Astrophysics Data System (ADS)

    Sullivan, Stacey J. L.; Dreher, Maureen L.; Zheng, Jiwen; Chen, Lynn; Madamba, Daniel; Miyashiro, Katie; Trépanier, Christine; Nagaraja, Srinidhi

    2015-09-01

    There is a public health need to understand the effects of surface layer thickness and composition on corrosion in nickel-containing medical devices. To address this knowledge gap, five groups of Nitinol stents were manufactured by various processing methods that altered the titanium oxide layer. The following surfaces were created: >3500 nm thick mixed thermal oxide (OT), ~420 nm thick mixed thermal oxide (SP), ~130 nm thick mixed thermal oxide (AF), ~4 nm thick native oxide (MP), and an ~4 nm thick passivated oxide (EP). Radially compressed and not compressed devices were evaluated for nickel (Ni) ion release in a 60-day immersion test. The results indicated that OT stents released the most Ni, followed by stents in the SP and AF groups. For OT and SP stents, which exhibited the thickest oxide layers, radial compression significantly increased Ni release when compared to non-compressed stents. This result was not observed in AF, MP, SP stents indicating that the increased Ni release may be explained by cracking of the thicker oxide layers during crimping. Strong correlations were observed between oxide layer thickness and cumulative Ni release. These findings elucidate the importance of oxide layer thickness and composition on uniform corrosion of laser-cut Nitinol stents.

  2. A Novel Thin Film Nitinol Covered Neurovascular Stent Significantly Decreases Intra-Aneurysmal Flow In Vitro

    NASA Astrophysics Data System (ADS)

    Chun, Youngjae; Hur, Soojung; Shayan, Mahdis; Kealey, Colin; Levi, Daniel; Mohanchandra, Kp; di Carlo, Dino; Carman, Gregory

    2013-11-01

    A novel thin film nitinol (TFN) stent has been developed to promote aneurysm quiescence by diminishing flow across the aneurysm's neck. Laboratory aneurysm models were used to assess the flow changes produced by stents covered with different patterns of TFN. Flow diversion stents were constructed by covering Wingspan stents (Boston Scientific, DxL:4x20mm) with TFNs (i.e., 77 and 82 percent porosity). The flow changes that occur after deployment of two different porous TFN covered stent in intracranial aneurysm models were evaluated in vitro. The 82 percent porous TFN covered stent reduced the intra-aneurysmal mean flow velocity by 86.42 percent, while a 77 percent porous TFN covered stent reduced to intra-aneurysmal mean flow velocity to 93.44 percent compared to a nonstented model. Local wall shear rates were also significantly reduced in wide-neck aneurysm model (i.e., 97.52 - 98.92 percent) with TFN stent placement. The results showed that TFN covered stents significantly reduced intra-aneurysmal flow velocity magnitudes and local wall shear rates. This suggests that TFN covered stents with both 77 and 82 percent porosity have great potential to promote thrombosis in both wide-necked and fusiform aneurysm sacs.

  3. Oversizing and Restenosis with Self-Expanding Stents in Iliofemoral Arteries

    SciTech Connect

    Saguner, Ardan M. Traupe, Tobias; Raeber, Lorenz; Hess, Nina; Banz, Yara; Saguner, Arhan R.; Diehm, Nicolas; Hess, Otto M.

    2012-08-15

    Purpose: Uncoated self-expanding nitinol stents (NS) are commonly oversized in peripheral arteries. In current practice, 1-mm oversizing is recommended. Yet, oversizing of NS may be associated with increased restenosis. To provide further evidence, NS were implanted in porcine iliofemoral arteries with a stent-to-artery-ratio between 1.0 and 2.3. Besides conventional uncoated NS, a novel self-expanding NS with an antiproliferative titanium-nitride-oxide (TiNOX) coating was tested for safety and efficacy. Methods: Ten uncoated NS and six TiNOX-coated NS (5-6 mm) were implanted randomly in the iliofemoral artery of six mini-pigs. After implantation, quantitative angiography (QA) was performed for calculation of artery and minimal luminal diameter. Follow-up was performed by QA and histomorphometry after 5 months. Results: Stent migration, stent fracture, or thrombus formation were not observed. All stents were patent at follow-up. Based on the location of the stent (iliac/femoral) and the stent-to-artery-ratio, stent segments were divided into 'normal-sized' (stent-to-artery-ratio < 1.4, n = 12) and 'oversized' (stent-to-artery-ratio {>=} 1.4, n = 9). All stent segments expanded to their near nominal diameter during follow-up. Normal-sized stent segments increased their diameter by 6% and oversized segments by 29%. A significant correlation between oversizing and restenosis by both angiography and histomorphometry was observed. Restenosis rates were similar for uncoated NS and TiNOX-coated NS. Conclusions: TiNOX-coated NS are as safe and effective as uncoated NS in the porcine iliofemoral artery. All stents further expand to near their nominal diameter during follow-up. Oversizing is linearly and positively correlated with neointimal proliferation and restenosis, which may not be reduced by TiNOX-coating.

  4. Implantation study of a tissue-engineered self-expanding aortic stent graft (bio stent graft) in a beagle model.

    PubMed

    Kawajiri, Hidetake; Mizuno, Takeshi; Moriwaki, Takeshi; Iwai, Ryosuke; Ishibashi-Ueda, Hatsue; Yamanami, Masashi; Kanda, Keiichi; Yaku, Hitoshi; Nakayama, Yasuhide

    2015-03-01

    The use of stent grafts for endovascular aortic repair has become an important treatment option for aortic aneurysms requiring surgery. This treatment has achieved excellent outcomes; however, problems like type 1 endoleaks and stent graft migration remain. Bio stent grafts (BSGs), which are self-expanding stents covered with connective tissue, were previously developed using "in-body tissue architecture" technology. We assessed their early adaptation to the aorta after transcatheter implantation in a beagle model. BSGs were prepared by subcutaneous embedding of acryl rods mounted with self-expanding nitinol stents in three beagles for 4 weeks (n = 3/dog). The BSGs were implanted as allografts into infrarenal abdominal aortas via the femoral artery of three other beagles. After 1 month of implantation, aortography revealed no stenosis or aneurysmal changes. The luminal surface of the BSGs was completely covered with neointimal tissue, including endothelialization, without any thrombus formation. The cover tissue could fuse the luminal surface of the native aorta with tight conjunctions even at both ends of the stents, resulting in complete impregnation of the strut into the reconstructed vascular wall, which is expected to prevent endoleaks and migration in clinical applications.

  5. Use of Micropatterned Thin Film Nitinol in Carotid Stents to Augment Embolic Protection

    PubMed Central

    Shayan, Mahdis; Jankowitz, Brian T.; Shridhar, Puneeth; Chun, Youngjae

    2016-01-01

    Stenting is an alternative to endarterectomy for the treatment of carotid artery stenosis. However, stenting is associated with a higher risk of procedural stroke secondary to distal thromboembolism. Hybrid stents with a micromesh layer have been proposed to address this complication. We developed a micropatterned thin film nitinol (M-TFN) covered stent designed to prevent thromboembolism during carotid intervention. This innovation may obviate the need or work synergistically with embolic protection devices. The proposed double layered stent is low-profile, thromboresistant, and covered with a M-TFN that can be fabricated with fenestrations of varying geometries and sizes. The M-TFN was created in multiple geometries, dimensions, and porosities by sputter deposition. The efficiency of various M-TFN to capture embolic particles was evaluated in different atherosclerotic carotid stenotic conditions through in vitro tests. The covered stent prevented emboli dislodgement in the range of 70%–96% during 30 min duration tests. In vitro vascular cell growth study results showed that endothelial cell elongation, alignment and growth behaviour silhouettes significantly enhance, specifically on the diamond-shape M-TFN, with the dimensions of 145 µm × 20 µm and a porosity of 32%. Future studies will require in vivo testing. Our results demonstrate that M-TFN has a promising potential for carotid artery stenting. PMID:27983574

  6. Effects of tissue digestion solutions on surface properties of nitinol stents.

    PubMed

    Sullivan, Stacey J L; Stafford, Philip; Malkin, Elon; Dreher, Maureen L; Nagaraja, Srinidhi

    2017-02-02

    Analysis of explanted medical implants can provide a wealth of knowledge about device safety and performance. However, the quality of information may be compromised if the methods used to clean tissue from the device disturb the retrieved condition. Common solutions used to digest tissue may adversely affect the surface of the device and its severity can be material and processing dependent. In this study, two groups of stents made from the same material (Nitinol) were shape set in a salt pot (SP) or further processed by mechanical polishing (MP) and then immersed in one of three tissue digestion solutions (TDS): nitric acid (HNO3 ), sodium hydroxide (NaOH), or papain enzyme (papain). Nickel (Ni) ion concentrations were measured for each stent-TDS combination and post-immersion stent surface constituents, morphology and oxide depths were compared to baseline samples. Exposure to the HNO3 TDS resulted in relatively high Ni ion release and surface damage for both stent types. Papain TDS induced a greater Ni ion release than NaOH TDS, however, both were significantly lower than HNO3 . The NaOH TDS increased the oxide layer thickness on MP stents. In contrast, all other stent immersions resulted in thinner oxide layers. For the Nitinol finishes used in this study, HNO3 is not recommended while papain and NaOH solutions may be appropriate depending on the post-retrieval analysis performed. This study elucidates the importance of preliminary testing for TDS selection and how the surface finish can affect the sensitivity of a material to a TDS. 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2017.

  7. A newly designed big cup nitinol stent for gastric outlet obstruction

    PubMed Central

    Shi, Ding; Liao, Sheng-Hui; Geng, Jian-Ping

    2010-01-01

    AIM: To find out whether a newly designed big cup nitinol stent is suitable for treatment of patients with gastric outlet obstruction resulting from gastric cancer. METHODS: The new stent is composed of a proximal big cup segment (20 mm in length and 48-55 mm in diameter), a middle part (60 mm in length and 20 mm in diameter) covered by a polyethylene membrane and a distal sphericity (20 mm in length and 28 mm in diameter). Half of the proximal big cup segment is also covered by a polyethlene membrane, which is adjacent to the middle part of the stent. The stent is preloaded in a 6.0-mm-diameter introducer system. Thirteen patients with gastric outlet obstruction resulting from gastric cancer received the new stents under endoscopic and fluoroscopic guidance. RESULTS: Technical success was achieved in 12 of 13 (92.3%) patients. Among the 12 patients in whom endoscopic stent was placed successfully, the clinical success rate was 91.7% during a follow-up of average 6.5 mo. During the first month follow-up, the migration rate was 0%, recurrent obstruction 0% and gastric bleeding 8.3%. During the follow-up between 2-12 mo, no migration, recurrent obstruction and gastric bleeding occurred. CONCLUSION: The proximal big cup segment seems to be effective and promising for technical efficacy, clinical outcome, and preventing migration and tumor ingrowth and increasing the emptying rate of sinus ventriculi. PMID:20806440

  8. Drug-coated balloons are replacing the need for nitinol stents in the superficial femoral artery.

    PubMed

    Kitrou, Panagiotis; Karnabatidis, Dimitrios; Katsanos, Konstantinos

    2016-08-01

    Amassed evidence from several randomized controlled trials and high quality meta-analyses clearly support the primary use of paclitaxel-coated balloons (PCB) in the superficial femoral artery over traditional plain balloon angioplasty or primary bare nitinol stenting with significantly lower vascular restenosis, less need for repeat procedures, improved quality of life and potential cost savings for the healthcare system. Stents may be reserved for bail-out in case of a suboptimal dilatation result, and for selected more complex lesions, or in case of critical limb ischemia in order to eliminate vessel recoil and maximize immediate hemodynamic gain. Debulking atherectomy remains unproven, but holds a lot of promise in particular in combination with PCBs, in order to improve compliance of the vessel wall by plaque removal, allow for a better angioplasty result and optimize drug transfer and bioavailability. The present overview summarizes and discusses current evidence about femoropopliteal PCB angioplasty compared to the historical standard of plain old balloon angioplasty and bare nitinol stents. Available evidence is appraised in the context of clinically meaningful results, relevant unresolved issues are highlighted, and future trends are discussed.

  9. Picosecond laser micromachining of nitinol and platinum-iridium alloy for coronary stent applications

    NASA Astrophysics Data System (ADS)

    Muhammad, N.; Whitehead, D.; Boor, A.; Oppenlander, W.; Liu, Z.; Li, L.

    2012-03-01

    The demand for micromachining of coronary stents by means of industrial lasers rises quickly for treating coronary artery diseases, which cause more than one million deaths each year. The most widely used types of laser for stent manufacturing are Nd:YAG laser systems with a wavelength of 1064 nm with pulse lengths of 10-3-10-2 seconds. Considerable post-processing is required to remove heat-affected zones (HAZ), and to improve surface finishes and geometry. Using a third harmonic laser radiation of picosecond laser (6×10-12 s pulse duration) in UV range, the capability of the picosecond laser micromachining of nitinol and platinum-iridium alloy for coronary stent applications are presented. In this study dross-free cut of nitinol and platinum-iridium alloy tubes are demonstrated and topography analysis of the cut surface is carried out. The HAZ characteristics have been investigated by means of microscopic examinations and measurement of micro-hardness distribution near the cut zones.

  10. Mechanical modeling of self-expandable stent fabricated using braiding technology.

    PubMed

    Kim, Ju Hyun; Kang, Tae Jin; Yu, Woong-Ryeol

    2008-11-14

    The mechanical behavior of a stent is one of the important factors involved in ensuring its opening within arterial conduits. This study aimed to develop a mechanical model for designing self-expandable stents fabricated using braiding technology. For this purpose, a finite element model was constructed by developing a preprocessing program for the three-dimensional geometrical modeling of the braiding structure inside stents, and validated for various stents with different braiding structures. The constituent wires (Nitinol) in the braided stents were assumed to be superelastic material and their mechanical behavior was incorporated into the finite element software through a user material subroutine (VUMAT in ABAQUS) employing a one-dimensional superelastic model. For the verification of the model, several braided stents were manufactured using an automated braiding machine and characterized focusing on their compressive behavior. It was observed that the braided stents showed a hysteresis between their loading and unloading behavior when a compressive load was applied to the braided tube. Through the finite element analysis, it was concluded that the current mechanical model can appropriately predict the mechanical behavior of braided stents including such hysteretic behavior, and that the hysteresis was caused by the slippage between the constituent wires and their superelastic property.

  11. Reduced thrombogenicity of nitinol stents--in vitro evaluation of different surface modifications and coatings.

    PubMed

    Tepe, Gunnar; Schmehl, Joerg; Wendel, Hans P; Schaffner, Sivio; Heller, Stephan; Gianotti, Marc; Claussen, Claus D; Duda, Stephan H

    2006-02-01

    The material and the surface patterns of intravascular stents play a pivotal role in activating platelets and triggering adherence of inflammatory cells that consecutively leads to renarrowing caused by neointimal hyperplasia. To improve these features, besides mechanical and chemical modifications, ways of masking the stent by covering have been developed. In addition, polymer-coated stents are used as vehicle for local drug delivery. But as substances used for this application are described to possess an inflammatory potential, this aspect has to be evaluated. In the present study we compared different approaches to surface alterations applied to a nitinol stent design. Besides commonly used techniques like passivation and electropolishing, we evaluated coatings with heparin, aluminium and a polyurethane polymer regarding their thrombogenic and inflammatory characteristics. By weaving thin elastomer fibres a graft was generated. The previously described Chandler loop was used to simulate arterial flow conditions ex vivo using rotating PVC tubings filled with human blood. All stents received 120 min of blood contact. To determine thrombocyte activation and inflammatory reaction, the platelet count and levels of beta-TG, TAT and PMN-elastase were assessed. Scanning electron microscopy was used to visualize the reactions. Mechanical polishing and passivation did not improve the stent surface characteristics while sandblasting, electropolishing and aluminium covering decreased activation of the coagulation cascade. In terms of thrombogenicity, the heparin coating had no beneficial effect. The lowest thrombogenic potential was found in the Polyurethane-coated stent group. All stents showed similar levels of polymorph nuclear granulocyte elastase except for the membrane design. While mechanical and chemical modifications are able to reduce thrombogenicity, coating with this particular polyurethane polymer seems to be superior to these approaches regarding the

  12. Development of tissue-engineered self-expandable aortic stent grafts (Bio stent grafts) using in-body tissue architecture technology in beagles.

    PubMed

    Kawajiri, Hidetake; Mizuno, Takeshi; Moriwaki, Takeshi; Ishibashi-Ueda, Hatsue; Yamanami, Masashi; Kanda, Keiichi; Yaku, Hitoshi; Nakayama, Yasuhide

    2015-02-01

    In this study, we aimed to describe the development of tissue-engineered self-expandable aortic stent grafts (Bio stent graft) using in-body tissue architecture technology in beagles and to determine its mechanical and histological properties. The preparation mold was assembled by insertion of an acryl rod (outer diameter, 8.6 mm; length, 40 mm) into a self-expanding nitinol stent (internal diameter, 9.0 mm; length, 35 mm). The molds (n = 6) were embedded into the subcutaneous pouches of three beagles for 4 weeks. After harvesting and removing each rod, the excessive fragile tissue connected around the molds was trimmed, and thus tubular autologous connective tissues with the stent were obtained for use as Bio stent grafts (outer diameter, approximately 9.3 mm in all molds). The stent strut was completely surrounded by the dense collagenous membrane (thickness, ∼150 µm). The Bio stent graft luminal surface was extremely flat and smooth. The graft wall of the Bio stent graft possessed an elastic modulus that was almost two times higher than that of the native beagle abdominal aorta. This Bio stent graft is expected to exhibit excellent biocompatibility after being implanted in the aorta, which may reduce the risk of type 1 endoleaks or migration.

  13. Accelerated fatigue behavior and mechano-physical characterizations of in vitro physiological simulation of nitinol stents.

    PubMed

    Saidane, K; Polizu, S; Yahia, L'h

    2007-01-01

    In this study, we have provided an experimental evaluation of the fatigue behavior of the nitinol (NiTi) endovascular device (peripheral stent). The accelerated fatigue tests were performed using arterial conditions, which mimicked actual physiological conditions. Natural, rubber latex-tubing materials were used to simulate human arteries. The equipment design and the test parameters used allowed for the simulation of a compliant artery and the application of circumferential forces to the device.The stent compliance values were good indicators for tracking the time evolution of fatigue behavior. Moreover, the analyses of changes on the surface morphology and on the chemical composition were used to establish a relationship between surface characteristics and peripheral stent response during 400 million cycles, which is equivalent to 10 yrs of human life. In order to determine the influence of the accelerated fatigue, an evaluation of both mechanical and surface characteristics was carried out before and after testing using the following tests and methods, respectively: radial hoop testing (RH), scanning electron microscope analysis (SEM), auger electron spectroscopy (AES), atomic absorption spectroscopy (AAS), and X-ray photoelectron spectroscopy (XPS). Under these experimental conditions, the studies have shown that after 400 million cycles, the tested stents did not demonstrate any mechanical failure. Moreover, the surface did not undergo any changes in its chemical composition. However, we did observe an increase in roughness and signs of pitting corrosion.

  14. Assessment of a Polyester-Covered Nitinol Stent in the Canine Aorta and Iliac Arteries

    SciTech Connect

    Castaneda, Flavio; Ball-Kell, Susan M.; Young, Kate; Li Ruizong

    2000-09-15

    Purpose: To evaluate the patency and healing characteristics of a woven polyester fabric-covered stent in the canine model.Methods: Twenty-four self-expanding covered stents were placed in the infrarenal aorta and bilateral common iliac arteries of eight dogs and evaluated at 1 (n = 2), 3 (n = 2), and 6 (n = 4) months. Stent assessment was done using angiography prior to euthanasia, and light and scanning electron microscopy.Results: Angiographically, just prior to euthanasia, 8 of 8 aortic and 14 of 16 iliac endovascular covered stents were patent. Histologically, the stented regions showed complete endothelialization 6 months after graft implantation. A neointima had formed inside the stented vessel regions resulting in complete encasement of the fabric-covered stent by 3 months after graft implantation. Medial compression with smooth muscle cell atrophy was present in all stented regions. Explanted stent wires, examined by scanning electron microscopy, showed pitting but no cracks or breakage.Conclusion: The covered stent demonstrated predictable healing and is effective in preventing stenosis in vessels 10.0 mm or greater in diameter but does not completely preclude stenosis in vessels 6.0 mm or less in diameter.

  15. Stent overlapping and geometric curvature influence the structural integrity and surface characteristics of coronary nitinol stents.

    PubMed

    Kapnisis, Konstantinos K; Halwani, Dina O; Brott, Brigitta C; Anderson, Peter G; Lemons, Jack E; Anayiotos, Andreas S

    2013-04-01

    Preliminary studies have revealed that some stents undergo corrosion and fatigue-induced fracture in vivo, with significant release of metallic ions into surrounding tissues. A direct link between corrosion and in-stent restenosis has not been clearly established; nonetheless in vitro studies have shown that relatively high concentrations of heavy metal ions can stimulate both inflammatory and fibrotic reactions, which are the main steps in the process of restenosis. To isolate the mechanical effects from the local biochemical effects, accelerated biomechanical testing was performed on single and overlapping Nickel-Titanium (NiTi) stents subjected to various degrees of curvature. Post testing, stents were evaluated using Scanning Electron Microscopy (SEM) to identify the type of surface alterations. Fretting wear was observed in overlapping cases, in both straight and curved configurations. Stent strut fractures occurred in the presence of geometric curvature. Fretting wear and fatigue fractures observed on stents following mechanical simulation were similar to those from previously reported human stent explants. It has been shown that biomechanical factors such as arterial curvature combined with stent overlapping enhance the incidence and degree of wear and fatigue fracture when compared to single stents in a straight tube configuration.

  16. Structural Evaluation of Radially Expandable Cardiovascular Stents Encased in a Polyurethane Film

    NASA Technical Reports Server (NTRS)

    Trigwell, Steve; De, Samiran; Sharma, Rajesh; Mazumder, Malay K.; Mehta, Jawahar L.

    2004-01-01

    A method of encasing cardiovascular stents with an expandable polyurethane coating has been developed to provide a smooth homogeneous inner wall allowing for a confluent growth of endothelial cells. In this design, the metal wire stent structure is completely covered by the polyurethane film minimizing biocorrosion of the metal (stainless steel or nitinol), and providing a homogeneous surface for surface treatment and incorporation of various eluting drugs to prevent platelet aggregation while supporting endothelialization. The polyurethane surface was treated with a helium plasma for sterilization and promotes growth of cells. The paper details the performance of the coated film to expand with the metal stent up to 225 % during deployment. We present stress/strain behavior of polyurethane films, and subsequent plasma treatment of the surface and the adhesion of the coating to the stent structure upon expansion. A film of less than 25 tm was found to be sufficient for corrosion resistance and flexibility without producing any excess stress on the stent structure. Straining the film to 225 % and plasma modification did not affect the mechanical and surface properties while allowing for improved biocompatibility as determined by the critical surface tension, surface chemistry, and roughness.

  17. Structural evaluation of radially expandable cardiovascular stents encased in a polyurethane film.

    PubMed

    Trigwell, Steve; De, Samiran; Sharma, Rajesh; Mazumder, Malay K; Mehta, Jawahar L

    2006-02-01

    A method of encasing cardiovascular stents with an expandable polyurethane coating has been developed to provide a smooth homogeneous inner wall allowing for a confluent growth of endothelial cells. In this design, the metal wire stent structure is completely covered by the polyurethane film, minimizing biocorrosion of the metal (stainless steel or nitinol), and providing a homogeneous surface for surface treatment and incorporation of various eluting drugs to prevent platelet aggregation while supporting endothelialization. The polyurethane surface was treated with a helium plasma for sterilization and promotes growth of cells. The article details the performance of the coated film to expand with the metal stent up to 225% during deployment. Stress/strain behavior of polyurethane films, subsequent plasma treatment of the surface, and the adhesion of the coating to the stent structure upon expansion are presented. A film of less than 25 microm was found to be sufficient for corrosion resistance and flexibility without producing any excess stress on the stent structure. Straining the film to 225% and plasma modification did not affect the mechanical and surface properties, but allowed for improved biocompatibility as determined by the critical surface tension, surface chemistry, and roughness.

  18. In vitro fatigue-crack growth and fracture toughness behavior of thin-walled superelastic Nitinol tube for endovascular stents: A basis for defining the effect of crack-like defects.

    PubMed

    Robertson, Scott W; Ritchie, Robert O

    2007-02-01

    Endovascular stents made of the superelastic nickel-titanium alloy Nitinol are subjected in service to tens of millions of loading cycles and even "single-event" overloads, both of which can potentially result in fracture and/or complete failure of the device. A fracture-mechanics-based methodology can provide a means to quantify relevant material parameters critical to the design against such failures. However, there is a dearth of relevant experimental data in the literature on such fracture-mechanics-based approaches to fatigue in Nitinol; furthermore, that which does exist invariably pertains to product forms that are not appropriate for stent manufacture, e.g., bulk Nitinol bar and strip. Consequently, the current work is focused on characterizing in vitro both subcritical and critical crack growth (fatigue-crack growth and R-curve fracture toughness) behavior in thin-walled ( approximately 400microm thick) Nitinol tubing similar to that used for medical device manufacture (following shape-setting procedures to flatten the material), with a resultant austenite finish temperature of A(f) approximately 25-30 degrees C, identical to self-expanding Nitinol stents. Fatigue-crack growth behavior, measured in Hanks' Balanced Saline Solution over a wide spectrum of growth rates (down to 10(-10)m/cycle) and at a range of positive load ratios (R=0.1-0.7), revealed significantly higher fatigue thresholds than had been previously reported for bulk Nitinol material. In addition, we examine the critical effect of test frequency, as most fatigue experiments on Nitinol have been performed at 30Hz or above, despite the fact that this is far in excess of the frequency of physiological loading. Finally, the fracture toughness properties are characterized in thin-section Nitinol and show marked crack-resistance (R-curve) behavior with a dependence on crack-growth angle (with respect to the tube drawing axis); additionally, measured toughnesses are found to be lower than has been

  19. Underwater femtosecond laser micromachining of thin nitinol tubes for medical coronary stent manufacture

    NASA Astrophysics Data System (ADS)

    Muhammad, Noorhafiza; Li, Lin

    2012-06-01

    Microprofiling of medical coronary stents has been dominated by the use of Nd:YAG lasers with pulse lengths in the range of a few milliseconds, and material removal is based on the melt ejection with a high-pressure gas. As a result, recast and heat-affected zones are produced, and various post-processing procedures are required to remove these defects. This paper reports a new approach of machining stents in submerged conditions using a 100-fs pulsed laser. A comparison is given of dry and underwater femtosecond laser micromachining techniques of nickel-titanium alloy (nitinol) typically used as the material for coronary stents. The characteristics of laser interactions with the material have been studied. A femtosecond Ti:sapphire laser system (wavelength of 800 nm, pulse duration of 100 fs, repetition rate of 1 kHz) was used to perform the cutting process. It is observed that machining under a thin water film resulted in no presence of heat-affected zone, debris, spatter or recast with fine-cut surface quality. At the optimum parameters, the results obtained with dry cutting showed nearly the same cut surface quality as with cutting under water. However, debris and recast formation still appeared on the dry cut, which is based on material vaporization. Physical processes involved during the cutting process in a thin water film, i.e. bubble formation and shock waves, are discussed.

  20. Long-term resistance to fracture and/or corrosion of the nitinol wires of the talent stent-graft: observations from a series of explanted devices.

    PubMed

    Lin, Jing; Guidoin, Robert; Wang, Lu; Zhang, Ze; Paynter, Royston; How, Thien; Nutley, Mark; Wei, Dangheng; Douville, Yvan; Samis, Gregory; Dionne, Guy; Gilbert, Nathalie

    2013-01-01

    The biodurability of the Nitinol wires used in stent-grafts retrieved from reoperations and autopsy was analyzed to assess the possible causes of fracture and/or corrosion of the stents. The Nitinol wires of six explanted devices presented a corrosion-free surface after in vivo service. The drawing lines in the control wires were still present, but neither burrs nor flakes were observed. Pits and crevices were rare, but some shallow ones were present. Some abrasions of the surfaces of the Nitinol wires were also observed. The chemical composition of the explanted devices showed the presence of organic contamination that covered the thick layer of titanium oxide before reaching the Nitinol itself. The durability of the Nitinol employed in the manufacture of the Talent stent-grafts was confirmed; the results of this study show the Nitinol to be resistant to corrosion. We have also concluded that the fractures of the Nitinol wires in two devices were unique adverse incidents caused by compression and bending related to the sharp angle of the Nitinol wires.

  1. Nitinol stent implantation for femoropopliteal disease in patients on hemodialysis: results of the 3-year retrospective multicenter APOLLON study.

    PubMed

    Fujihara, Masahiko; Higashimori, Akihiro; Kato, Yoshihiro; Taniguchi, Hiromasa; Iwasaki, Yusuke; Amano, Tomonori; Sumiyoshi, Akinori; Nishiya, Daisuke; Yokoi, Yoshiaki

    2016-09-01

    The clinical outcomes of nitinol stents for femoropopliteal arterial (FP) disease in patients on hemodialysis were assessed. Endovascular therapy (EVT) is accepted for symptomatic FP disease. However, the clinical outcomes of patients on dialysis are not well known. A multicenter retrospective study was conducted with data between November 2010 and August 2013. A total of 484 consecutive patients who successfully underwent EVT for FP disease with nitinol stents were recruited and analyzed. Patients were categorized into the hemodialysis group (N = 161) and non-hemodialysis group (N = 323). The primary measure was primary patency verified by duplex ultrasound at a rest peak systolic velocity (PSVR) of >2.5, and secondary measures were freedom from target lesion revascularization (TLR) and major amputation-free survival (AFS). Average follow-up duration was 19.5 ± 13.5 months. The primary patency rate at 3 years was significantly lower in the hemodialysis group than the non-hemodialysis group (33.8 vs. 43.7 %; p = 0.036). Freedom from TLR at 3 years was 55.0 % in the hemodialysis group and 66.1 % in the non-hemodialysis group (p = 0.032). The hemodialysis group showed a significantly lower AFS rate at 3 years than the non-hemodialysis group (86.4 vs. 58.2 %; p < 0.001). In hemodialysis patients, nitinol stent use resulted in a lower patency rate, higher TLR rate, and lower AFS rate compared to non-hemodialysis patients. These data suggest that nitinol stent implantation for FP arteries in hemodialysis patient needs to be reconsidered.

  2. Biodegradable and elastomeric poly(glycerol sebacate) as a coating material for nitinol bare stent.

    PubMed

    Kim, Min Ji; Hwang, Moon Young; Kim, JiHeung; Chung, Dong June

    2014-01-01

    We synthesized and evaluated biodegradable and elastomeric polyesters (poly(glycerol sebacate) (PGS)) using polycondensation between glycerol and sebacic acid to form a cross-linked network structure without using exogenous catalysts. Synthesized materials possess good mechanical properties, elasticity, and surface erosion biodegradation behavior. The tensile strength of the PGS was as high as 0.28 ± 0.004 MPa, and Young's modulus was 0.122 ± 0.0003 MPa. Elongation was as high as 237.8 ± 0.64%, and repeated elongation behavior was also observed to at least three times the original length without rupture. The water-in-air contact angles of the PGS surfaces were about 60°. We also analyzed the properties of an electrospray coating of biodegradable PGS on a nitinol stent for the purpose of enhancing long-term patency for the therapeutic treatment of varicose veins disease. The surface morphology and thickness of coating layer could be controlled by adjusting the electrospraying conditions and solution parameters.

  3. Self-Expandable Stent for Repairing Coarctation of the Left-Circumferential Aortic Arch with Right-sided Descending Aorta and Aberrant Right Subclavian Artery with Kommerell's Aneurysm.

    PubMed

    Khajali, Zahra; Sanati, Hamid Reza; Pouraliakbar, Hamidreza; Mohebbi, Bahram; Aeinfar, Kamran; Zolfaghari, Reza

    2017-01-01

    Endovascular treatment offers a great advantage in the management of main arteries stenoses. However, simultaneous presence of a group of anomalies may complicate the situation. Here we present a case of 21-year-old man with aortic coarctation. Radiographic imaging and angiography demonstrated aortic coarctation of the left-circumferential aortic arch, right-sided descending aorta, and Kommerell's diverticulum at the origin of right subclavian artery. These anomalies have rarely been reported to concurrently exist in the same case and the treatment is challenging. Percutaneous treatment for repair of aortic coarctation was successfully performed with deployment of self-expanding nitinol stents. Follow-up demonstrated the correction of blood pressure and improvement of the symptoms. It appears that deployment of self-expandable nitinol stents present a viable option for the management of coarcted aorta in patients having all or some of these anomalies together.

  4. Study of the Behavior of a Bell-Shaped Colonic Self-Expandable NiTi Stent under Peristaltic Movements

    PubMed Central

    Puértolas, José A.; López, Enrique

    2013-01-01

    Managing bowel obstruction produced by colon cancer requires an emergency intervention to patients usually in poor conditions, and it requires creating an intestinal stoma in most cases. Regardless of that the tumor may be resectable, a two-stage surgery is mandatory. To avoid these disadvantages, endoscopic placement of self-expanding stents has been introduced more than 10 years ago, as an alternative to relieve colonic obstruction. It can be used as a bridge to elective single-stage surgery avoiding a stoma or as a definitive palliative solution in patients with irresectable tumor or poor estimated survival. Stents must be capable of exerting an adequate radial pressure on the stenosed wall, keeping in mind that stent must not move or be crushed, guaranteeing an adequate lumen when affected by peristaltic waves. A finite element simulation of bell-shaped nitinol stent functionality has been done. Catheter introduction, releasing at position, and the effect of peristaltic wave were simulated. To check the reliability of the simulation, a clinical experimentation with porcine specimens was carried out. The stent presented a good deployment and flexibility. Stent behavior was excellent, expanding from the very narrow lumen corresponding to the maximum peristaltic pressure to the complete recovery of operative lumen when the pressure disappears. PMID:23841067

  5. Use of self-expanding stents for better intracranial flow diverter wall apposition.

    PubMed

    Kühn, Anna Luisa; Wakhloo, Ajay K; Gounis, Matthew J; Kan, Peter; de Macedo Rodrigues, Katyucia; Lozano, J Diego; Marosfoi, Miklos G; Perras, Mary; Brooks, Christopher; Howk, Mary C; Rex, David E; Massari, Francesco; Puri, Ajit S

    2017-04-01

    Background Flow diverter (FD) malapposition is associated with stroke-related complications. We document the use of self-expanding nitinol stents to remove/reduce the ledge of a FD deployed for aneurysm treatment. Methods We identified five patients who were treated with the Pipeline embolization device (PED) in conjunction with a Neuroform EZ stent for inadequate wall apposition of the ends of the FD at our institution between May 2014 and July 2015. Among other parameters, angiographic results, cone-beam computed tomography assessment of wall apposition and patient clinical outcome were evaluated. Results Incomplete device end apposition was seen in three cases, and precarious positioning of the distal end of the PED over the aneurysm neck was seen in two cases. In all five cases, successful treatment with good wall apposition and proper pinning of the PED distal edge was achieved using an additional Neuroform EZ stent. Appropriate aneurysm neck coverage and flow stagnation was seen in all cases. The combination of high radial outward force and open-cell design permits the Neuroform EZ stent to jail the malappositioned edges of the FD while maintaining good vessel-wall apposition itself and prevent migration of the PED. Short-term follow-up angiography showed device patency and complete aneurysm obliteration in all cases. Conclusions Preliminary results of this small case series suggest that the Neuroform EZ stent allows for effective treatment of FD malapposition in selected patients amenable for this endovascular approach. Long-term and larger cohort studies are needed to validate these results.

  6. Numerical Modeling of Nitinol Stent Oversizing in Arteries with Clinically Relevant Levels of Peripheral Arterial Disease: The Influence of Plaque Type on the Outcomes of Endovascular Therapy.

    PubMed

    Gökgöl, Can; Diehm, Nicolas; Büchler, Philippe

    2017-02-01

    Oversizing of the Nitinol stents in the femoro-popliteal arterial tract is commonly performed by clinicians and further encouraged by stent manufacturers. However, in spite of the procedure's supposed benefits of strong wall apposition and increased luminal gain, its effects on the mechanical behavior of arteries with peripheral arterial disease are not fully clear. In this study, finite element (FE) analyses of endovascular revascularization of an idealized artery with 70% stenosis and three different plaque types have been performed to examine the influence of Nitinol stent oversizing on the arterial stresses and acute lumen gain. The analyses included the simulation of balloon angioplasty to model plaque failure, followed by stent implantation, in which four different oversizing ratios were investigated. Results showed that balloon angioplasty was crucial in determining the stress levels of the artery prior to stent implantation and heavily affected the outcome of endovascular therapy. For all plaque types, Nitinol stent oversizing was found to produce a marginal lumen gain in contrast to a significant increase in arterial stresses. For the arteries with lightly and moderately calcified plaques, oversizing was found to be non-critical; whereas for the arteries with heavily calcified plaques, the procedure should be avoided due to a risk of tissue failure.

  7. First in human experience of a new self-expandable percutaneous pulmonary valve implantation using knitted nitinol-wire and tri-leaflet porcine pericardial valve in the native right ventricular outflow tract.

    PubMed

    Kim, Gi Beom; Kwon, Bo Sang; Lim, Hong Gook

    2017-02-01

    Balloon-expandable percutaneous pulmonary valve systems using the Melody and Edwards SAPIEN transcatheter heart valves have been increasingly used instead of surgically implantable pulmonary valves. However, limited patients with right ventricular outflow tract (RVOT) lesions are suitable candidates for percutaneous pulmonary valve implantation (PPVI) using these systems after surgical correction of tetralogy of Fallot. Therefore, larger self-expandable valved-stents are being developed for native RVOT lesions. We report the first-in-human case of a new self-expandable PPVI in a patient with a native RVOT lesion using a newly made knitted nitinol-wire stent mounted with a tri-leaflet porcine pericardial valve developed in South Korea. © 2017 Wiley Periodicals, Inc.

  8. MR safety and imaging of neuroform stents at 3T.

    PubMed

    Nehra, Arvind; Moran, Christopher J; Cross, Dewitte T; Derdeyn, Colin P

    2004-10-01

    The Neuroform stent is a self-expanding nitinol stent designed for use in wide-necked intracranial aneurysms. Heating and imaging artifacts were evaluated by using a porcine carotid artery aneurysm model in a 3T MR system. A suspended Neuroform stent was tested for deflection. No heating was measured, and no evidence of deflection of the stent was found. Imaging artifacts were minimal. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible.

  9. Balloon-expandable covered stent therapy of complex endovascular pathology.

    PubMed

    Giles, Heath; Lesar, Christopher; Erdoes, Luke; Sprouse, Richard; Myers, Stuart

    2008-11-01

    The current study was designed to investigate our hypotheses that balloon-expandable covered stents display acceptable function over longitudinal follow-up in patients with complex vascular pathology and provide a suitable alternative for the treatment of recurrent in-stent restenosis. All stents were Atrium iCast, which is a balloon-mounted, polytetrafluoroethylene-covered stent with a 6F/7F delivery system. A retrospective review was performed of 49 patients with 66 stented lesions. Data were analyzed with life tables and t-tests. The most commonly treated vessels were the iliac (61%) and renal (24%) arteries. Indications for covered stent placement were unstable atheromatous lesions (50%), recurrent in-stent restenosis (24%), aneurysm (8%), aortic bifurcation reconstruction (7.5%), dissection (4.5%), endovascular aneurysm repair-related (4.5%), and stent fracture (1.5%). Patency was assessed by angiogram or duplex ultrasonography. The primary end point was patency and secondary end points were technical success and access-site complications. Mean follow-up was 13 months (range 1.5-25). The technical success rate was 97%. Unsuccessful outcomes were due to deployment error (n=1) and stent malpositioning (n=1). The cohort (n=64) 6- and 12-month primary patency rates were 96% and 84%, respectively. Twelve-month assisted primary patency was 98%. Iliac artery stents (n=38) had a primary patency of 97% at 6 months and 84% at 12 months with an assisted primary patency of 100% at 12 months. Renal artery stents (n=16) had a primary patency of 92% at 6 months and 72% at 12 months with an assisted primary patency of 92% at 6 and 12 months. Stents placed for recurrent in-stent restenosis (n=16) had a primary patency of 85%, assisted primary patency of 93%, and a 15% restenosis rate at 12 months. Specifically, stents placed for renal artery recurrent in-stent restenosis (n=10) had a primary patency of 73%, assisted primary patency of 82%, and a restenosis rate of 27%. The

  10. In Vitro Comparison of Self-Expanding Versus Balloon-Expandable Stents in a Human Ex Vivo Model

    SciTech Connect

    Grenacher, Lars Rohde, Stefan Gaenger, Ellen; Deutsch, Jochen; Kauffmann, Guenter W.; Richter, Goetz M.

    2006-04-15

    The objective was to compare the radial strength and expansile precision of self-expanding stents and balloon-expandable stents in a human cadaver bifurcation model. Seven different self-expanding (LUMINEXX, JOSTENT SelfX, JOSTENT SelfX hrf, Sinus-Repo, Sinus SuperFlex, Easy Wallstent, SMART) and four different balloon-expandable stent models (Palmaz, Sinus Stent, SAXX Medium, JOSTENT peripheral), each type 10 stents (total n = 110 stents) were implanted into the common iliac arteries of human cadaver corpses. The maximum stent diameter was 10 mm for all models. After stent implantation, the specimens were filled with silicone caoutchouc. After 24 h, the vascular walls including the stents were removed from the hardened casts. Diameters were taken and the weight of the cast cylinders was measured in air and in purified water to calculate the volume of the bodies (according to Archimedes Law) as a relative but precise degree for the radial strength of the implanted stents. The cylindrical casts of the self-expanding stents showed lower mean diameters (8.2 {+-} 1.0 mm) and mean volumes (0.60 {+-} 0.14 ml/cm) than in the balloon-expandable stent group (10.1 {+-} 0.3 mm and 0.71 {+-} 0.04 ml/cm, respectively; p < 0.01). The nominal maximum diameter of 10 mm was not achieved in any of the self-expanding stents, but this was achieved in more than 70% (29/40) of the balloon-expandable stent specimens (p < 0.05). The variation between achieved volumes was significantly larger in self-expanding (range: 0.23-0.78 ml/cm) than in balloon-expandable stents (range: 0.66-0.81 ml/cm; p < 0.05). Self-expanding stents presented considerably lower radial expansion force and lower degree of precision than balloon-expandable stents.

  11. In vitro comparison of self-expanding versus balloon-expandable stents in a human ex vivo model.

    PubMed

    Grenacher, Lars; Rohde, Stefan; Gänger, Ellen; Deutsch, Jochen; Kauffmann, Günter W; Richter, Götz M

    2006-01-01

    The objective was to compare the radial strength and expansile precision of self-expanding stents and balloon-expandable stents in a human cadaver bifurcation model. Seven different self-expanding (LUMINEXX, JOSTENT SelfX, JOSTENT SelfX hrf, Sinus-Repo, Sinus SuperFlex, Easy Wallstent, SMART) and four different balloon-expandable stent models (Palmaz, Sinus Stent, SAXX Medium, JOSTENT peripheral), each type 10 stents (total n = 110 stents) were implanted into the common iliac arteries of human cadaver corpses. The maximum stent diameter was 10 mm for all models. After stent implantation, the specimens were filled with silicone caoutchouc. After 24 h, the vascular walls including the stents were removed from the hardened casts. Diameters were taken and the weight of the cast cylinders was measured in air and in purified water to calculate the volume of the bodies (according to Archimedes Law) as a relative but precise degree for the radial strength of the implanted stents. The cylindrical casts of the self-expanding stents showed lower mean diameters (8.2 +/- 1.0 mm) and mean volumes (0.60 +/- 0.14 ml/cm) than in the balloon-expandable stent group (10.1 +/- 0.3 mm and 0.71 +/- 0.04 ml/cm, respectively; p < 0.01). The nominal maximum diameter of 10 mm was not achieved in any of the self-expanding stents, but this was achieved in more than 70% (29/40) of the balloon-expandable stent specimens (p < 0.05). The variation between achieved volumes was significantly larger in self-expanding (range: 0.23-0.78 ml/cm) than in balloon-expandable stents (range: 0.66-0.81 ml/cm; p < 0.05). Self-expanding stents presented considerably lower radial expansion force and lower degree of precision than balloon-expandable stents.

  12. Expandable bioresorbable endovascular stent. I. Fabrication and properties.

    PubMed

    Su, Shih-Horng; Chao, Robert Y N; Landau, Charles L; Nelson, Kevin D; Timmons, Richard B; Meidell, Robert S; Eberhart, Robert C

    2003-06-01

    A bioresorbable, expandable poly(L-lactic acid) stent has been designed, based on a linear, continuous coil array principle, by which multiple furled lobes convert to a single lobe upon balloon expansion, without heating. Stent strength and compliance are sufficient to permit deployment by a conventional balloon angioplasty catheter. Several multiple lobe configurations were investigated, with expansion ratios ranging from 1.4 to 1.9 and expanded diameters ranging from 2.3 to 4.7 mm. Compression resistance of the expanded stent is dependent on fiber coil density and fiber ply. A range sufficient for endovascular service was obtained, with less than 4% elastic recoil in six day saline incubation studies. Surface plasma treatment with di(ethylene glycol) vinyl ether significantly reduced platelet adhesion in a 1 h porcine arteriovenous shunt model. Patency was maintained in one week implant studies in the porcine common femoral artery. However, a strong inflammatory response, and significant reduction of the vascular lumen were observed following two weeks implantation. The design principles and fabrication techniques for this bioresorbable stent are sufficiently versatile that a broad range of applications can be addressed. Much work remains to be done, including long-term evaluation of the inflammatory response, and of polymer degradation. The results of this study demonstrate the feasibility of expandable biodegradable stent design and deployment by conventional means.

  13. Stent Fracture and Reocclusion After Placement of a Single Self-Expanding Stent in the Common Iliac Artery and Endovascular Treatment

    SciTech Connect

    Higashiura, Wataru Sakaguchi, Shoji; Morimoto, Kengo; Kichikawa, Kimihiko

    2008-09-15

    We present a case of fracture of a single self-expanding stent placed in the common iliac artery (CIA). An 80-year-old woman underwent placement of a self-expanding stent for CIA occlusion. Stent fracture and reocclusion were detected after 18 months. Successful revascularization was achieved using a stent-in-stent maneuver. The possibility of stent fracture with reocclusion should be considered following treatment with a single self-expanding stent for CIA occlusion.

  14. Use of a Nitinol Wire Stent for Management of Severe Tracheal Stenosis in an Eclectus Parrot (Eclectus roratus).

    PubMed

    Mejia-Fava, Johanna; Holmes, Shannon P; Radlinsky, MaryAnn; Johnson, Dan; Ellis, Angela E; Mayer, Jörg; Schnellbacher, Rodney; Divers, Stephen J

    2015-09-01

    A 25-year-old, female eclectus parrot (Eclectus roratus) presented for dyspnea 3 weeks after anesthesia and surgery for egg yolk coelomitis. Radiography, computed tomography, and tracheoscopy revealed multiple tracheal strictures spanning a length of 2.6 cm in the mid to distal trachea. Histopathologic examination revealed mild fibrosis, inflammation, and hyperplasia consistent with acquired tracheal strictures. Tracheal resection was not considered possible because of the length of the affected trachea. The strictures were resected endoscopically, and repeated balloon dilation under fluoroscopic guidance over the course of 10 months resulted in immediate but unsustained improvement. Computed tomography was used to measure the stenotic area. A 4 × 36-mm, custom-made, nitinol wire stent was inserted into the trachea under fluoroscopic guidance. After stent placement, intermittent episodes of mild to moderate dyspnea continued, and these responded to nebulization with a combination of saline, acetylcysteine, and dexamethasone. Multiple attempts to wean the patient off nebulization therapy and to switch to a corticosteroid-free combination were unsuccessful. The parrot eventually developed complications, was euthanatized, and necropsy was performed. Histologically, the tracheal mucosa had widespread erosion to ulceration, with accumulation of intraluminal exudate and bacteria, severe degeneration of skeletal muscle and tracheal rings, prominent fibrosis, and mild to moderate, submucosal inflammation. Clinicopathologic findings in this case suggested tracheomalacia, which has not been previously described in birds. Custom-made tracheal stents can be used for severe tracheal stenosis in birds when tracheal resection and anastomosis is not possible. Complications of tracheal stent placement in birds may include tracheitis and tracheomalacia. To our knowledge, this is the first report of tracheal stent placement in an avian species.

  15. Simulations of Self-Expanding Braided Stent Using Macroscopic Model of NiTi Shape Memory Alloys Covering R-Phase

    NASA Astrophysics Data System (ADS)

    Frost, M.; Sedlák, P.; Kruisová, A.; Landa, M.

    2014-07-01

    Self-expanding stents or stentgrafts made from Nitinol superelastic alloy are widely used for a less invasive treatment of disease-induced localized flow constriction in the cardiovascular system. The therapy is based on insertion of a stent into a blood vessel to maintain the inner diameter of the vessel; it provides highly effective results at minimal cost and with reduced hospital stays. However, since stent is an external mechanical healing tool implemented into human body for quite a long time, information on the mechanical performance of it is of fundamental importance with respect to patient's safety and comfort. Advantageously, computational structural analysis can provide valuable information on the response of the product in an environment where in vivo experimentation is extremely expensive or impossible. With this motivation, a numerical model of a particular braided self-expanding stent was developed. As a reasonable approximation substantially reducing computational demands, the stent was considered to be composed of a set of helical springs with specific constrains reflecting geometry of the structure. An advanced constitutive model for NiTi-based shape memory alloys including R-phase transition was employed in analysis. Comparison to measurements shows a very good match between the numerical solution and experimental results. Relation between diameter of the stent and uniform radial pressure on its surface is estimated. Information about internal phase and stress state of the material during compression loading provided by the model is used to estimate fatigue properties of the stent during cyclic loading.

  16. An in vivo pilot study of a microporous thin film nitinol-covered stent to assess the effect of porosity and pore geometry on device interaction with the vessel wall.

    PubMed

    Chun, Youngjae; Kealey, Colin P; Levi, Daniel S; Rigberg, David A; Chen, Yanfei; Tillman, Bryan W; Mohanchandra, K P; Shayan, Mahdis; Carman, Gregory P

    2017-03-01

    Sputter-deposited thin film nitinol constructs with various micropatterns were fabricated to evaluate their effect on the vessel wall in vivo when used as a covering for commercially available stents. Thin film nitinol constructs were used to cover stents and deployed in non-diseased swine arteries. Swine were sacrificed after approximately four weeks and the thin film nitinol-covered stents were removed for histopathologic evaluation. Histopathology revealed differences in neointimal thickness that correlated with the thin film nitinol micropattern. Devices covered with thin film nitinol with a lateral × vertical length = 20 × 40 µm diamond pattern had minimal neointimal growth with well-organized cell architecture and little evidence of ongoing inflammation. Devices covered with thin film nitinol with smaller fenestrations exhibited a relatively thick neointimal layer with inflammation and larger fenestrations showed migration of inflammatory and smooth muscle cells through the micro fenestrations. This "proof-of-concept" study suggests that there may be an ideal thin film nitinol porosity and pore geometry to encourage endothelialization and incorporation of the device into the vessel wall. Future work will be needed to determine the optimal pore size and geometry to minimize neointimal proliferation and in-stent stenosis.

  17. Comparison of Self-Expanding Polyethylene Terephthalate and Metallic Stents Implanted in Porcine Iliac Arteries

    SciTech Connect

    Wilczek, Krzysztof; Scheerder, Ivan de; Wang Kai; Verbeken, Eric; Piessens, Jan

    1996-05-15

    Purpose: Comparison of the biocompatibility of self-expanding polyethylene terephthalate (PET) stents with self-expanding metallic stents (Wallstents). Methods: Diameter- and length-matched PET stents and Wallstents were symmetrically implanted in the paired iliac arteries of 13 crossbred domestic swine. Stent deployment was studied angiographically and with intravascular ultrasound immediately after stent implantation. The angiographic stented lumen diameter was measured using quantitative vessel analysis before, immediately after stenting, and at 6-week follow-up. Cross-section histopathology and area morphometry were performed. Results: Immediately poststenting, intravascular ultrasound revealed proximal dislocation of 5 of the 13 PET stents, whereas all metal stents were firmly embedded at the implantation site. At 6-week follow-up, three of the remaining PET stents were totally or subtotally occluded by organized thrombus, whereas all metal stents were patent. Compared with immediately poststenting, the angiographic lumen diameter within the five remaining PET stents was reduced by 30%, and that of the metallic stents was virtually unaltered (p < 0.02). This observation was confirmed by postmortem morphometry, wherein the PET-stented vessel segments a diameter stenosis of 40% was measured vs only 9% in the metallic stents (p < 0.0001). Conclusion: PET-stent deployment is difficult to control due to the lack of radiopacity of this stent. PET stents seem to be more thrombogenic and lead to significantly more neointimal proliferation than metallic stents.

  18. [Results of the upper digestive tract stenting with self-expanding stents].

    PubMed

    Fedorov, A G; Davydova, S V; Klimov, A E; Lebedev, N V

    2013-01-01

    The work is based on the analysis of the palliative treatment of 66 patients with malignant upper digestive tract obstruction who underwent implantation of 75 self-expanding metallic stents in the period of 2003-2012 yy. Early postoperative complications developed in 10 (15.2%) cases. Procedure-related complications were observed in 8 (12.1%) patients, non-specific complications occurred in 2 (3.0%) patients. In-hospital lethality was 4.5% (3 patients). 51 patients were followed until death. Symptomatic relapse of obstruction was observed in 4 cases. Median survival was 97 days. Stenting with self-expanding metal stents was concluded to be an effective and safe method of palliation of malignant upper digestive tract stenosis.

  19. Self-expandable metallic stents in nonmalignant large airway disease.

    PubMed

    Fortin, Marc; MacEachern, Paul; Hergott, Christopher A; Chee, Alex; Dumoulin, Elaine; Tremblay, Alain

    2015-01-01

    Airway self-expandable metallic stents (SEMS) were initially studied in malignant airway obstruction; however, their use in benign airway diseases has become progressively more frequent. This may be explained by their ease of insertion compared with silicone stents, which require rigid bronchoscopy for insertion. While initial experience with SEMS in benign disease suggested efficacy and promising short-term safety profile, long-term follow-up revealed significant complication rates. In addition to a high complication rate, the management of these complications is made more difficult by the semipermanent nature of these devices. Reported complications include infection, granulation tissue formation, stent migration, stent fracture, airway perforation and fistula formation, as well as extension of the initial injury, potentially eliminating other therapeutic options such as surgical resection. Therefore, SEMS should only be used in nonmalignant large airway disease as a last resort for patients in whom other endoscopic methods, including silicone stents and dilations, as well as surgical options have failed or are technically not feasible.

  20. Mechanical Characteristics of Composite Knitted Stents

    SciTech Connect

    Tokuda, Takanori Shomura, Yuzo; Tanigawa, Noboru; Kariya, Shuji; Komemushi, Atsushi; Kojima, Hiroyuki; Sawada, Satoshi

    2009-09-15

    We used metal wires and fibers to fabricate a composite knitted stent and then compare the mechanical characteristics of this stent with those of a pure metallic stent of the same construction in order to develop a stent that offers a comparable degree of expandability as metallic stents but can be used for highly curved lesions that cannot be treated using metallic stents. We fabricated two types of composite knitted stent (N-Z stents), using nitinol wire with a diameter of 0.12 mm and polypara-phenylene-benzobisoxazole (PBO) multifilament fiber (Zyron AS; Toyobo, Osaka, Japan). Stents were knitted into a cylindrical shape using the same textile pattern as a Strecker stent. Two loop lengths (L) of nitinol wire were used in the N-Z stents: L = 1.84 mm (N-Z stent L = 1.84) and L = 2.08 mm (N-Z stent L = 2.08). For the sake of comparison, we fabricated a metallic stent of nitinol using the same textile pattern (N-N stent L = 1.92). We applied a radial compression force diametrically to each stent and applied a bending force diametrically at the free end of a stent with one end fixed in order to evaluate the relationship between stent elasticity and load values. In addition, we macroscopically evaluated the generation of kinks when the stent was bent 180{sup o}. The radial compressive force when the stent diameter was reduced by 53% was 6.44 N in the case of N-Z stent L = 1.84, 6.14 N in the case of N-Z stent L = 2.08, and 4.96 N in the case of N-N stent L = 1.92 mm. The composite stent had a radial compressive force higher than that of a metallic stent. The restoring force to longitudinal direction at a 90{sup o} bending angle was 0.005 N for N-Z stent L = 1.84, 0.003 N for N-Z stent L = 2.08, and 0.034 N for N-N stent L = 1.92. The restoring force of the composite stent was significantly lower. Finally, the composite stent generated no definitive kinks at a bending angle of 180{sup o}, regardless of loop length. However, the N-N stent clearly produced kinks, causing

  1. Comparison of Small Intestinal Submucosa-Covered and Noncovered Nitinol Stents with PTFE Endografts in Injured Ovine Femoral Arteries: A Pilot Study

    SciTech Connect

    Nakata, Manabu; Pavcnik, Dusan Uchida, Barry T.; Van Alstine, William; Timmermans, Hans A.; Toyota, Naoyuki; Terada, Masaki; Brountzos, Elias; Kaufman, John A.; Keller, Frederick S.; Rosch, Josef

    2003-09-15

    The purpose of this study was to compare performance of small intestinal submucosa (SIS)-covered endografts (SCEs) to polytetra-fluoroethylene (PTFE)-covered endografts (PCEs) and to bare nitinol stents (BSs) in injured sheep femoral artery (FA). Bare Zilver 6 mm x 40 mm nitinol stents (n = 6), Zilver stents covered with SIS (n = 6), and Palmaz stents 6 mm x 37 mm covered with PTFE (n = 6) were implanted in the balloon-injured FAs of nine female sheep. Follow-up arteriograms were obtained before animal sacrifice at 1, 3 and 6 months, with three animals at each time point. The FAs with the implanted device were explanted for histologic studies and morphologic measurements. Stent implantation was technically successful in all sheep. All BS and SCEs were patent at each time point. Five BSs and five SCEs exhibited formation of progressive eccentric intimal hyperplasia (IH) that was more advanced in SCE at 6 months. Cross-sectional area narrowing averaged 60% for BSs and 67% for SCEs. One BS, one SCE and two patent PCEs exhibited mild-to-moderate formation of concentric IH. Four PCS occluded one at 1 month, two at 3 months and one at 6 months. Performance of the devices placed into sheep FAs depended on their relation to the curving peri-articular portion of the FA during extremity flexion. BSs and SCEs placed in this portion exhibited progressive growth of eccentric IH while PCEs placed in this portion occluded.

  2. Differences in Endothelial Injury After Balloon Angioplasty, Insertion of Balloon-Expanded Stents or Release of Self-Expanding Stents: An Electron Microscopic Experimental Study

    SciTech Connect

    Harnek, Jan; Zoucas, Evita; Carlemalm, Erik; Cwikiel, Wojciech

    1999-01-15

    Purpose: To evaluate which of six different commonly available stents inserted into an artery without percutaneous transluminal angioplasty (PTA) causes the least endothelial damage. To compare the degree of endothelial injury after insertion of such a stent with injury caused by PTA. Methods: Twelve healthy pigs were used in the experiments. In the first part of the study six different types of stents were inserted into the common iliac arteries. In the second part of the study self-expanding stents with large spaces between the wires were used. PTA was performed in the contralateral iliac artery. The pigs were killed immediately after the procedure and resected specimens examined after fixation, using scanning electron microscopy. Results: All procedures but two were accomplished successfully. More endothelium was preserved after insertion of self-expanding stents with large spaces between the wires, compared with stents with small spaces and balloon-expanded stents. After insertion of self-expanding stents with large spaces, 50.1% {+-} 16.4% of the endothelium remained intact, compared with only 5.6% {+-} 7.7% after PTA. The difference was statistically significant (p < 0.001). Conclusion: Self-expanding stents with large spaces between the wires, inserted without PTA, cause less damage to the endothelium than other stents and significantly less damage than PTA.

  3. Analysis of New Nitinol Ingot Qualities

    NASA Astrophysics Data System (ADS)

    Steegmüller, Rainer; Ulmer, Jochen; Quellmalz, Michael; Wohlschlögel, Markus; Schüßler, Andreas

    2014-07-01

    New ingot qualities, processed by optimized vacuum arc remelting (VAR), optimized vacuum induction melting followed by VAR and VAR followed by electron beam remelting, were compared with standard quality. Finished components as well as diamond-shaped samples representing a typical dimension of self-expanding stents were produced using Nitinol tubing drawn from the new ingot qualities. Metallographic longitudinal sections were prepared and analyzed to determine inclusion size and distributions of the various ingot qualities. Radial force and uniaxial tensile tests were used to determine the mechanical properties of fully processed material and tubing, respectively. Transformation temperatures of tubing as delivered from supplier and processed stents were measured by differential scanning calorimetry and deformation-and-free-recovery testing. Finally, fatigue tests were performed on diamond-shaped samples to evaluate the strain-life characteristics of the new ingot qualities. Results of this study are compared to ADMEDES historical data from standard Nitinol materials to gain an assessment of the new improved ingot qualities with regard to the production of Nitinol vascular implants. The latest developments in Nitinol ingot quality are highlighted and the results of the comparison from technical point of view are shown.

  4. Bench-top Comparison of Physical Properties of 4 Commercially-Available Self-Expanding Intracranial Stents

    PubMed Central

    Cho, Su-hee; Jo, Won-il; Jo, Ye-eun; Yang, Ku Hyun; Park, Jung Cheol

    2017-01-01

    Purpose To better understand the performance of four commercially available neurovascular stents in intracranial aneurysm embolization, the stents were compared in terms of their basic morphological and mechanical properties. Materials and Methods Four different types of stents that are currently being used for cerebral aneurysm embolization were prepared (two stents per type). Two were laser-cut stents (Neuroform and Enterprise) and two were braided from a single nitinol wire (LEO and LVIS stents). All were subjected to quantitative measurements of stent size, pore density, metal coverage, the force needed to load, push, and deploy the stent, radial force on deployment, surface roughness, and corrosion resistance. Results Compared to their nominal diameters, all stents had greater diameters after deployment. The length generally decreased after deployment. This was particularly marked in the braided stents. The braided stents also had higher pore densities than the laser-cut stents. Metal coverage was highest in the LEO stent (14%) and lowest in the Enterprise stent (5%). The LIVS stent had the highest microcatheter loading force (81.5 gf). The LEO stent had the highest passage force (55.0 gf) and deployment force (78.9 gf). The LVIS and LEO stents had the highest perpendicular (37.1 gf) and circumferential (178.4 gf) radial forces, respectively. The Enterprise stent had the roughest stent wire, followed by the LVIS, LEO, and Neuroform stents. Conclusion The four neurovascular stent types differed in terms of morphological and physical characteristics. An understanding of this diversity may help to decide which stent is most suitable for specific clinical situations. PMID:28316867

  5. A comparison of FE beam and continuum elements for typical nitinol stent geometries

    NASA Astrophysics Data System (ADS)

    Ballew, Wesley; Seelecke, Stefan

    2009-03-01

    With interest in improved efficiency and a more complete description of the SMA material, this paper compares finite element (FE) simulations of typical stent geometries using two different constitutive models and two different element types. Typically, continuum elements are used for the simulation of stents, for example the commercial FE software ANSYS offers a continuum element based on Auricchio's SMA model. Almost every stent geometry, however, is made up of long and slender components and can be modeled more efficiently, in the computational sense, with beam elements. Using the ANSYS user programmable material feature, we implement the free energy based SMA model developed by Mueller and Seelecke into the ANSYS beam element 188. Convergence behavior for both, beam and continuum formulations, is studied in terms of element and layer number, respectively. This is systematically illustrated first for the case of a straight cantilever beam under end loading, and subsequently for a section of a z-bend wire, a typical stent sub-geometry. It is shown that the computation times for the beam element are reduced to only one third of those of the continuum element, while both formulations display a comparable force/displacement response.

  6. Emerging Stent and Balloon Technologies in the Femoropopliteal Arteries

    PubMed Central

    Pastromas, Georgios; Katsanos, Konstantinos; Krokidis, Miltiadis; Karnabatidis, Dimitrios

    2014-01-01

    Endovascular procedures for the management of the superficial femoral (SFA) and popliteal artery disease are increasingly common. Over the past decade, several stent technologies have been established which may offer new options for improved clinical outcomes. This paper reviews the current evidence for SFA and popliteal artery angioplasty and stenting, with a focus on randomized trials and registries of nitinol self-expanding stents, drug-eluting stents, dug-coated balloons, and covered stent-grafts. We also highlight the limitations of the currently available data and the future routes in peripheral arterial disease (PAD) stent and balloon technology. PMID:24672355

  7. Evaluation of the Effects of Temporary Covered Nitinol Stent Placement in the Prostatic Urethra: Short-Term Study in the Canine Model

    SciTech Connect

    Crisostomo, Veronica; Uson-Gargallo, Jesus

    2007-07-15

    Purpose. To evaluate the effect of temporary stent placement on the canine prostatic urethra. Methods. Retrievable PTFE-covered nitinol stents were placed in the prostatic urethras of 8 beagle dogs under fluoroscopic guidance. Retrograde urethrography was obtained before and after stenting. Retrograde urethrography and endoscopy were performed 1 and 2 months after deployment. The endoscopic degree of hyperplasia was rated on a scale of 0 to 4 (0 absence, 4 = occlusion). On day 60, stents were removed and urethrography was performed immediately before euthanasia. Pathologic analysis was performed to determine the degree of glandular atrophy, periurethral fibrosis, and urethral dilation. Results. Stent deployment was technically successful in 7 animals, and failed in 1 dog due to a narrow urethral lumen. Complete migration was seen in 2 animals at 1 month, and an additional stent was deployed. On day 30, endoscopy showed slight hyperplasia (grade 1) in 3 animals. On day 60, moderate hyperplasia (grade 2) was evidenced in 4 cases. No impairment of urinary flow was seen during follow-up. Retrieval was technically easy to perform, and was successful in all dogs. The major histologic findings were chronic inflammatory cell infiltrates; prostate glandular atrophy, with a mean value of 1.86 (SD 0.90); periurethral fibrosis, with a mean ratio of 29.37 (SD 10.41); and dilatation of the prostatic urethra, with a mean ratio of 6.75 (SD 3.22). Conclusion. Temporary prostatic stent placement in dogs is safe and feasible, causing marked enlargement of the prostatic urethral lumen. Retrievable covered stents may therefore be an option for bladder outlet obstruction management in men.

  8. Use of a New Hybrid Heparin-Bonded Nitinol Ring Stent in the Popliteal Artery: Procedural and Mid-term Clinical and Anatomical Outcomes

    SciTech Connect

    Parthipun, Aneeta; Diamantopoulos, Athanasios; Kitrou, Panagiotis; Padayachee, Soundrie; Karunanithy, Narayan; Ahmed, Irfan; Zayed, Hany; Katsanos, Konstantinos E-mail: katsanos@med.upatras.gr

    2015-08-15

    PurposeTo report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery.Materials and MethodsThis was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford–Becker stage 3–6; P1–P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in-stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVR > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan–Meier (K–M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes.ResultsFrom August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford–Becker stage was five at baseline and 37/50 (74.0 %) were chronic total occlusions. Technical success was achieved in all cases (100 %). Stented lesion length was 114.2 ± 36.9 mm (range 6–20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2 % with an 86.1 ± 5.9 % freedom from TLR and 87 ± 5.0 % AFS (K–M estimates).ConclusionThe TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.

  9. Implantability, Complications, and Follow-Up After Transjugular Intrahepatic Portosystemic Stent-Shunt Creation With the 6F Self-Expanding Sinus-SuperFlex-Visual Stent

    PubMed Central

    Spira, Daniel; Wiskirchen, Jakub; Lauer, Ulrich; Ketelsen, Dominik; Nikolaou, Konstantin; Wiesinger, Benjamin

    2016-01-01

    Background The transjugular intrahepatic portosystemic stent-shunt (TIPSS) builds a shortcut between the portal vein and a liver vein, and represents a sophisticated alternative to open surgery in the management of portal hypertension or its complications. Objectives To describe clinical experiences with a low-profile nitinol stent system in TIPSS creation, and to assess primary and long-term success. Patients and Methods Twenty-six patients (5 females, 21 males; mean age 54.6 years) were treated using a low-profile 6F self-expanding sinus-SuperFlex-Visual stent system. The indication for TIPSS creation was refractory bleeding in 9 of the 26 patients, refractory ascites in 18 patients, and acute thrombosis of the portal vein confluence in one patient. Portosystemic pressure gradients before and after TIPSS, periprocedural and long-term complications, and the time to orthotopic liver transplantation (OLT) or death were recorded. Results The portosystemic pressure gradient was significantly reduced, from 20.9 ± 6.3 mmHg before to 8.2 ± 2.3 mmHg after TIPSS creation (P < 0.001). Procedure-related complications included acute tract occlusion (n = 2), liver hematoma (n = 1), hepatic encephalopathy (n = 1), and cardiac failure (n = 1). Three of the 26 patients had late-onset TIPSS occlusion (at 12, 12, and 39 months after TIPSS creation). Three patients died within one week after the procedure due to their poor general condition (multiorgan failure, acute respiratory distress syndrome, necrotizing pancreatitis, and aspiration pneumonia). Another four patients succumbed to their underlying advanced liver disease within one year after TIPSS insertion. Seven patients underwent OLT at a mean time of 9.4 months after TIPSS creation. Conclusion The sinus-SuperFlex-Visual stent system can be safely deployed as a TIPSS device. The pressure gradient reduction was clinically sufficient to treat the patients’ symptoms, and periprocedural complications were due to the TIPSS

  10. Tracheobronchial tree: expandable metallic stents used in experimental and clinical applications. Work in progress.

    PubMed

    Wallace, M J; Charnsangavej, C; Ogawa, K; Carrasco, C H; Wright, K C; McKenna, R; McMurtrey, M; Gianturco, C

    1986-02-01

    An expandable stainless steel stent was formulated for use in the treatment of tracheobronchial stenosis, tracheomalacia, and airway collapse following tracheal reconstruction. The stents were placed through an endotracheal tube into the trachea and bronchi of 11 healthy dogs. The stents expanded over time, substantially increasing the diameter of the lumen. Slight migration occasionally occurred, while an inflammatory reaction was noted in each animal. The stents were successfully used in the treatment of two cancer patients to dilate a postoperative bronchial stenosis that caused pneumonia and to support a tracheal graft that collapsed with respiration. Because of the stent migration in experimental studies, designs are being tested to develop stents with greater stability. These stents may be effective in overcoming stenosis caused by scarring, extrinsic compression, and collapse of reconstructed tracheobronchial structures.

  11. Comparison of the Fatigue Performance of Commercially Produced Nitinol Samples versus Sputter-Deposited Nitinol

    NASA Astrophysics Data System (ADS)

    Siekmeyer, Gerd; Schüßler, Andreas; de Miranda, Rodrigo Lima; Quandt, Eckhard

    2014-07-01

    Self-expanding vascular implants are typically manufactured from Nitinol tubing, using laser cutting, shape setting, and electropolishing processes. The mechanical and fatigue behavior of those devices are affected by the raw material and its processing such as the melting process and subsequent warm and cold forming processes. Current trends focus on the use of raw material with fewer inclusions to improve the fatigue performance. Further device miniaturization and higher fatigue life requirements will drive the need toward smaller inclusions and new manufacturing methods. As published previously, the high-cycle fatigue region of medical devices from standard processed Nitinol is usually about 0.4-0.5% half-alternating strain. However, these results highly depend on the ingot and semi-finished materials, the applied manufacturing processes, the final dimensions of test samples, and applied test methods. Fabrication by sputter deposition is favorable, because it allows the manufacturing of micro-patterned Nitinol thin-film devices without small burrs, heat-affected zones, microcracks, or any contamination with carbides, as well as the fabrication of complex components e.g., 3D geometries. Today, however, there is limited data available on the fatigue behavior for real stent devices based on such sputter-deposited Nitinol. A detailed study (e.g., using metallographic methods, corrosion, tensile, and fatigue testing) was conducted for the first time in order to characterize the micro-patterned Nitinol thin-film material.

  12. Role of laser photoablative therapy and expandable metal stents in colorectal carcinoma

    NASA Astrophysics Data System (ADS)

    Chennupati, Raja S.; Trowers, Eugene A.

    2000-05-01

    Metallic stents are effective in relieving colorectal obstruction in more than 80% of cases. Self expanding metallic stents allow for decompression of the proximal colon and preoperative bowel cleansing. Hence, emergent surgery for large bowel obstruction with its associated high morbidity and mortality might be avoided. Endoscopic laser photoablation and stent placement may successfully palliate inoperable colorectal cancer patients by maintaining luminal patency and avoiding the need for a colostomy. Major complications associated with metallic stents include pressure necrosis, perforation, bleeding and migration. The effectiveness of expandable metallic stents in obstructive colorectal carcinoma is critically reviewed. The authors present a concise review of the effectiveness of endoscopic laser photoablation and expandable metal stent placement.

  13. Understanding the requirements of self-expandable stents for heart valve replacement: Radial force, hoop force and equilibrium.

    PubMed

    Cabrera, María Sol; Oomens, Cees W J; Baaijens, Frank P T

    2017-04-01

    A proper interpretation of the forces developed during stent crimping and deployment is of paramount importance for a better understanding of the requirements for successful heart valve replacement. The present study combines experimental and computational methods to assess the performance of a nitinol stent for tissue-engineered heart valve implantation. To validate the stent model, the mechanical response to parallel plate compression and radial crimping was evaluated experimentally. Finite element simulations showed good agreement with the experimental findings. The computational models were further used to determine the hoop force on the stent and radial force on a rigid tool during crimping and self-expansion. In addition, stent deployment against ovine and human pulmonary arteries was simulated to determine the hoop force on the stent-artery system and the equilibrium diameter for different degrees of oversizing.

  14. Sequential Structural and Fluid Dynamics Analysis of Balloon-Expandable Coronary Stents: A Multivariable Statistical Analysis.

    PubMed

    Martin, David; Boyle, Fergal

    2015-09-01

    Several clinical studies have identified a strong correlation between neointimal hyperplasia following coronary stent deployment and both stent-induced arterial injury and altered vessel hemodynamics. As such, the sequential structural and fluid dynamics analysis of balloon-expandable stent deployment should provide a comprehensive indication of stent performance. Despite this observation, very few numerical studies of balloon-expandable coronary stents have considered both the mechanical and hemodynamic impact of stent deployment. Furthermore, in the few studies that have considered both phenomena, only a small number of stents have been considered. In this study, a sequential structural and fluid dynamics analysis methodology was employed to compare both the mechanical and hemodynamic impact of six balloon-expandable coronary stents. To investigate the relationship between stent design and performance, several common stent design properties were then identified and the dependence between these properties and both the mechanical and hemodynamic variables of interest was evaluated using statistical measures of correlation. Following the completion of the numerical analyses, stent strut thickness was identified as the only common design property that demonstrated a strong dependence with either the mean equivalent stress predicted in the artery wall or the mean relative residence time predicted on the luminal surface of the artery. These results corroborate the findings of the large-scale ISAR-STEREO clinical studies and highlight the crucial role of strut thickness in coronary stent design. The sequential structural and fluid dynamics analysis methodology and the multivariable statistical treatment of the results described in this study should prove useful in the design of future balloon-expandable coronary stents.

  15. Status and Literature Review of Self-Expandable Metallic Stents for Malignant Colorectal Obstruction

    PubMed Central

    Cheung, Dae Young; Lee, Yong Kook

    2014-01-01

    Use of colorectal stents has increased dramatically over the last decades. Colorectal stents offer an alternative way to relieve fatal intestinal obstruction and can take place of emergency surgery, which associated with significant morbidity and mortality and a high incidence of stoma creation, to elective resection. Although there remain a few concerns regarding the use of stents as a bridge to surgical resection, use of self-expandable metallic stents for palliation in patients with unresectable disease has come to be generally accepted. Advantages of colorectal stents include acute restoration of luminal patency and allowance of time for proper staging and surgical optimization, and the well-known disadvantages are procedure-related complications including perforation, migration, and stent failure. General indications, procedures, and clinical outcomes as well as recent evidences regarding the use of colorectal stents will be discussed in this review. PMID:24570885

  16. Thoracic Discitis as a Complication of Self-Expanding Metallic Stents in Esophageal Carcinoma

    SciTech Connect

    McQueen, A. S.; Eljabu, W.; Latimer, J. Raju, P. P. J.

    2011-02-15

    The role of metallic stents in the palliation of esophageal cancer is well established. Self-expanding metal stents (SEMSs) are frequently used, as they provide an effective and safe method of relieving malignant dysphagia. A number of complications are associated with the use of SEMSs, including esophageal perforation. We report a case of thoracic discitis occurring in a patient with advanced esophageal malignancy, treated with SEMSs. We propose that the likely etiology in this patient was esophageal perforation by a metallic stent.

  17. Self-expanding stents and aortoiliac occlusive disease: a review of the literature

    PubMed Central

    Bekken, Joost A; Jongsma, Hidde; de Vries, Jean-Paul PM; Fioole, Bram

    2014-01-01

    The treatment of symptomatic aortoiliac occlusive disease has shifted from open to endovascular repair. Both short- and long-term outcomes after percutaneous angioplasty and stenting rival those after open repair and justify an endovascular-first approach. In this article, we review the current endovascular treatment strategies in patients with aortoiliac occlusive disease, indications for primary and selective stenting in the iliac artery, and physical properties and future perspectives of self-expanding stents. PMID:24833925

  18. The development of self-expanding peripheral stent with ion-modified surface layer

    NASA Astrophysics Data System (ADS)

    Lotkov, Alexander I.; Kashin, Oleg A.; Kudryashov, Andrey N.; Krukovskii, Konstantin V.; Kuznetsov, Vladimir M.; Borisov, Dmitry P.; Kretov, Evgenii I.

    2016-11-01

    In work researches of chemical composition of surface layers of self-expanding stents of nickel-titanium (NiTi) and their functional and mechanical properties after plasma immersion processing by ions of silicon (Si). It is established that in the treatment in the inner and outer surfaces of stents formed doped silicon layer with a thickness of 80 nm. The formation of the doped layer does not impair the functional properties of the stent. At human body temperature, the stent is fully restore its shape after removing the deforming load. The resulting graph of loading of stents during their compression between parallel plates. The research results allow the conclusion that Si-doped stents are promising for treatment of peripheral vascular disease. However, related studies on laboratory animals are required.

  19. Expandable polyester silicon-covered stent for malignant esophageal strictures before neoadjuvant chemoradiation: a pilot study.

    PubMed

    Siddiqui, Ali A; Loren, David; Dudnick, Robert; Kowalski, Thomas

    2007-03-01

    Patients with resectable esophageal cancer often require placement of a surgical jejunostomy tube prior to receiving chemoradiation so as to maintain adequate nutrition due to their inability to swallow and eat. This study reports a single institutional experience with the Polyflex self-expanding silicone stent (Riisch; Kernen. Germany) in patients with malignant stenosis receiving chemoradiation prior to esophagectomy. This was a retrospective, nonrandomized study of 6 patients who underwent Polyflex esophageal stent placement across a malignant stricture prior to receiving neoadjuvant chemoradiation. The study assessed procedural success, restoration of oral nutrition, migration, and removal of the Polyflex stent. The outcomes measured were the efficacy of treatment, stent-related complications, and changes in the nutritional status of the patient after stent placement. Stent placement was successful in 5 of 6 patients (83%). Restoration of oral nutrition after stent placement occurred in 5 of 5 patients (100%). Migration of the stent into the stomach occurred in 3 patients (60%) without occurrence of gastric outlet obstruction; there was no proximal migration. Stents were successfully removed endoscopically or at the time of esophagectomy. This early experience suggests that the removable silicone Polyflex stent is an effective alternative to a surgical jejunostomy tube for the management of malignant esophageal stenosis in patients for whom neoadjuvant chemoradiation is planned prior to esophagectomy.

  20. Design and modeling balloon-expandable coronary stent for manufacturability

    NASA Astrophysics Data System (ADS)

    Suryawan, D.; Suyitno

    2017-02-01

    Coronary artery disease (CAD) is a disease that caused by narrowing of the coronary artery. The narrowing coronary artery is usually caused by cholesterol-containing deposit (plaque) which can cause a heart attack. CAD is the most common cause mortality in Indonesia. The commonly CAD treatment use the stent to opens or alleviate the narrowing coronary artery. In this study, the stent design is optimized for the manufacturability. Modeling is used to determine the free stent expansion due to applied pressure in the inner surface of the stent. The stress distribution, outer diameter change, and dogboning phenomena are investigated in the simulation. The result of modeling and simulating was analyzed and used to optimize the stent design before it is manufactured using EDM (Electric Discharge Machine) in the next research.

  1. [A case of severe motor and intellectual disability with tracheal stenosis due to granulation caused by metal stents treated successfully by silicone stents].

    PubMed

    Kotani, Haruko; Hino, Hiroyuki; Shiraishi, Taisuke; Ogura, Hideo

    2002-11-01

    A silicone stent (Dumon stent) was used in a severe motor and intellectual disability with severe tracheal stenosis due to granulation caused by an implanted the expanded metal stent (Ultraflex Nitinol Stent). To treat tracheobronchial malacia, diagnosed in infancy, expanded metalic stent was implanted at the ages of 30 and 32 years. However, a few months after the second implantation, progressive dyspnea appeared, and he had to use a respirator under intravenous anesthesia. Bronchoscopy showed re-stenosis of the trachea due to a granulation tissue within the stent. A Dumon stent was applied to control the re-stenosis. He was successfully weaned from a respirator. Since granulation tissue had recurred at the end of the Dumon stent after 3 months, a long term care of the airway and regular observation is necessary after implantation of stents.

  2. Stent-coil treatment of a distal internal carotid artery dissecting pseudoaneurysm on a redundant loop by use of a flexible, dedicated nitinol intracranial stent.

    PubMed

    Pride, G Lee; Replogle, Robert E; Rappard, George; Graybeal, Christopher L Taylor Dion; White, Jonathan; Purdy, Phillip

    2004-02-01

    Treatment of dissecting pseudoaneurysms of the distal cervical internal carotid artery with preservation of the parent artery by using stents or coils has become routine. Tortuosity remains a significant obstacle to successful endovascular treatment in some cases. We report the use of a stent-coil technique to treat a nonhealing dissecting pseudoaneurysm and associated stenosis with anatomic preservation of a redundant loop involving the stented arterial segment. This was accomplished by using a Neuroform dedicated intracranial stent.

  3. Elastic Deformation Properties of Implanted Endobronchial Wire Stents in Benign and Malignant Bronchial Disease: A Radiographic In Vivo Evaluation

    SciTech Connect

    Hautmann, Hubert; Rieger, Johannes; Huber, Rudolf M.; Pfeifer, Klaus J.

    1999-03-15

    Purpose: To evaluate the long-term mechanical behavior in vivo of expandable endobronchial wire stents, we imaged three different prostheses in the treatment of tracheobronchial disease. Methods: Six patients with bronchial stenoses (three benign, three malignant) underwent insertion of metallic stents. Two self-expandable Wallstents, two balloon-expandable tantalum Strecker stents and two self-expandable nitinol Accuflex stents were used. Measurements of deformation properties were performed during voluntary cough by means of fluoroscopy, at 1 month and 7-10 months after implantation. The procedures were videotaped, their images digitized and the narrowing of stent diameters calculated at intervals of 20 msec. Results: After stent implantation all patients improved with respect to ventilatory function. Radial stent narrowing during cough reached 53% (Wallstent), 59% (tantalum Strecker stent), and 52% (nitinol Accuflex stent) of the relaxed post-implantation diameter. Stent compression was more marked in benign compared with malignant stenoses. In the long term permanent deformation occurred with the tantalum Strecker stents; the other stents were unchanged. Conclusion: Endobronchial wire stents can be helpful in the treatment of major airway collapse and obstructing bronchial lesions. However, evidence of material fatigue as a possible effect of exposure to recurrent mechanical stress on the flexible mesh tube may limit their long-term use. This seems to be predominantly important in benign bronchial collapse.

  4. Management of cervical esophageal strictures with self-expanding metalic stents.

    PubMed

    Cindoruk, Mehmet; Karakan, Tarkan

    2006-12-01

    Esophageal strictures due to malignant diseases are treated with self-expanding metalicic stents. However, experience is limited with these metalic stents in the cervical esophagus. Due to technical difficulties and procedure-related complications, the cervical esophagus has been assigned as a risky area for stenting procedures. Another encountered problem is patient discomfort after the procedure. In this case report, we present three patients with cervical esophageal strictures who were successfully treated with self-expandable metalic stents. Two of these patients had inoperable esophageal carcinoma and the third had benign stenosis due to radiotherapy of larynx carcinoma. The two patients with malignant disease survived four and six months, respectively, after the procedure. The last patient with benign disease is still alive and has been without dysphagia symptom for six months.

  5. DISCOVER: Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents in the common iliac artery: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia. It can lead to serious complications such as infection, amputation and even death. Revascularization relieves symptoms and prevents these complications. Historically, open surgical repair, in the form of endarterectomy or bypass, was used. Over the last decade, endovascular repair has become the first choice of treatment for iliac arterial occlusive disease. No definitive consensus has emerged about the best endovascular strategy and which type of stent, if any, to use. However, in more advanced disease, that is, long or multiple stenoses or occlusions, literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery (Jongkind V et al., J Vasc Surg 52:1376-1383,2010). Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH, USA) has been introduced for the iliac artery. Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates (Dolmatch B et al. J Vasc Interv Radiol 18:527-534,2007, Marin ML et al. J Vasc Interv Radiol 7:651-656,1996, Virmani R et al. J Vasc Interv Radiol 10:445-456,1999). However, only one RCT, of mediocre quality has been published on this stent in the common iliac artery (Mwipatayi BP et al. J Vasc Surg 54:1561-1570,2011, Bekken JA et al. J Vasc Surg 55:1545-1546,2012). Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents. Methods/Design This is a prospective, randomized, controlled, double-blind, multi-center trial. The study population consists of human volunteers aged over 18 years, with symptomatic advanced atherosclerotic disease of the common iliac artery, defined as stenoses longer than 3 cm and occlusions. A total of 174 patients will be included. The control group will undergo endovascular dilatation or

  6. Miniaturized Self-Expanding Drug-Eluting Stent in Small Coronary Arteries: Late Effectiveness

    PubMed Central

    de Oliveira, Flavio Roberto Azevedo; Mattos, Luiz Alberto Piva e; Abizaid, Alexandre; Abizaid, Andrea S.; Costa, J. Ribamar; Costa, Ricardo; Staico, Rodolfo; Botelho, Roberto; Sousa, J. Eduardo; Sousa, Amanda

    2013-01-01

    Background Small vessels represent a risk factor for restenosis in percutaneous coronary angioplasty (PCA). The Sparrow® self-expanding drug-eluting stent, which has a lower profile than the current systems, has never been tested in this scenario. Objectives To evaluate the late effectiveness of the Sparrow® drug-eluting stent, regarding in-stent late lumen loss (LLL). Methods Patients with ischemia, symptomatic or documented, were submitted to PCA in vessels with reference diameter < 2.75 mm, divided into two groups regarding Sparrow® stent type: group 1: Sparrow® drug-eluting stent (DES), group 2: Sparrow® bare metal stent (BMS). Clinical follow-up duration was 12 months. Evaluation using quantitative coronary angiography (QCA) was performed immediately and at 8 months. A decrease of over 65% of in-stent LLL with DES was estimated to calculate sample size. IBM® SPSS software, release 19 (Chicago, Illinois, USA) was used for the statistical analysis. Results A total of 24 patients were randomized, 12 in each group. The DES and BMS groups were similar in age (63.25 ± 10.01 vs. 64.58 ± 11.54, p = 0.765), male gender (58.3% vs. 33.3%, p = 0.412), risk factors and all angiographs aspects. Immediate results were satisfactory in both groups. At 8 months in-stent late lumen loss was significantly lower in DES than in BMS group (DES vs. BMS 0.25 ± 0.16 0.97 ± 0.76, p = 0.008). Conclusion In small-vessel PCA, the Sparrow® DES determined significant reduction in in-stent LLL, when compared to Sparrow® BMS. PMID:24100691

  7. Fracture and Collapse of Balloon-Expandable Stents in the Bilateral Common Iliac Arteries Due to Shiatsu Massage

    SciTech Connect

    Ichihashi, Shigeo Higashiura, Wataru; Itoh, Hirofumi; Sakaguchi, Shoji; Kichikawa, Kimihiko

    2012-12-15

    We report a case of stent fracture and collapse of balloon-expandable stents caused by shiatsu massage. A 76-year-old man presented with complaints of intermittent claudication of the right lower extremity. Stenoses of the bilateral common iliac arteries (CIAs) were detected. Balloon-expandable stents were deployed in both CIAs, resulting in resolution of symptoms. Five months later, pelvis x-ray showed collapse of both stents. Despite the stent collapse, the patient was asymptomatic, and his ankle brachial index values were within the normal range. Further history showed that the patient underwent daily shiatsu therapy in the umbilical region, which may have triggered collapse of the stent. Physicians should advise patients to avoid compression of the abdominal wall after implantation of a stent in the iliac artery.

  8. Comparison of Drug-eluting Coronary Stents, Bare Coronary Stents and Self-expanding Stents in Angioplasty of Middle Cerebral Artery Stenoses

    PubMed Central

    Lee, Jong-Hyeog; Jo, Sung-Min; Jo, Kwang-Deog; Kim, Moon-Kyu; Lee, Sang-Youl

    2013-01-01

    Objective The purpose of this study is to investigate the results of treatment using stent-angioplasty for symptomatic middle cerebral arterial (MCA) stenosis and comparison of in-stent restenosis between drug-eluting stents (DES), bare metal coronary stents (BMS) and self-expanding stents (SES). Materials and Methods From Jan. 2007 to June. 2012, 34 patients (mean age ± standard deviation: 62.9 ± 13.6 years) with MCA stenosis were treated. Inclusion criteria were acute infarction or transient ischemic attacks (TIAs) and angiographically proven symptom related severe stenosis. Stents used for treatment were DES (n = 8), BMS (n = 13) and SES (n = 13). National Institutes of Health Stroke Scale (NIHSS) at admission was 2.5 ± 3.1 and mean stenosis rate was 79.0 ± 8.2%. Assessment of clinical and angiographic results was performed retrospectively. Results Among 34 patients, periprocedural complications occurred in four cases (11.8%), however, only two cases (6.0%) were symptomatic. All patients were followed clinically (mean follow-up period; 40.7 ± 17.7 months) and 31 were followed angiographically (91.2%. 13.4 ± 8.5 months). There was no occurrence of repeat stroke in all patients; however, mild TIAs related to restenosis occurred in three of 34 patients (8.8%). The mean NIHSS after stent-angioplasty was 1.7 ± 2.9 and 0.8 ± 1.1 at discharge. The modified Rankin score (mRS) at discharge was 0.5 ± 0.9 and 0.3 ± 0.8 at the last clinical follow-up. In-stent restenosis over 50% occurred in five of 31 angiographically followed cases (16.1%), however, all of these events occurred only in patients who were treated with BMS or SES. Restenosis rate was 0.0% in the DES group and 20.8% in the other group (p = 0.562); it did not differ between BMS and SES (2/11 18.2%, 3/13 23.1%, p = 1.000). Conclusion Stent-angioplasty appears to be effective for symptomatic MCA stenosis. As for restenosis, in our study, DES was presumed to be more effective than BMS and SES; meanwhile

  9. Self-Expandable Metal Stenting of Refractory Upper Gut Corrosive Strictures: A New Role for Endoscopy?

    PubMed Central

    Manta, Raffaele; Conigliaro, Rita; Bertani, Helga; Manno, Mauro; Soliman, Ahmed; Fedeli, Paolo; Bassotti, Gabrio

    2011-01-01

    Caustic strictures of the gastrointestinal tract are often difficult to treat, since relapses are frequent after medical or endoscopic treatment. Thus, novel approaches are needed. We report here our experience with self-expandable metallic stents (SEMS) as a new endoscopic approach in three patients with corrosive strictures of the upper gastrointestinal tract. PMID:22606415

  10. Clinical effect of double coaxial self-expandable metallic stent in management of malignant colon obstruction

    PubMed Central

    Won, Yoodong; Lee, Su Lim; Ku, Young Mi; Kim, Ki Tae; Won, Hye Sung; An, Chang Hyeok

    2015-01-01

    PURPOSE We aimed to evaluate the clinical effectiveness and safety of double coaxial self-expandable metallic stent (DCSEMS) in management of malignant colonic obstruction as a bridge to surgery or palliation for inoperable patients. METHODS Between April 2006 and December 2012, 49 patients (27 males and 22 females; median age, 68 years; age range, 38–91 years) were selected to receive decompressive therapy for malignant colonic obstruction by implanting a DCSEMS. Application of DCSEMS was attempted in 49 patients under fluoroscopic guidance. The obstruction was located in the transverse colon (n=2), descending colon (n=7), sigmoid colon (n=24), rectosigmoid junction (n=6), and the rectum (n=10). The intended use of DCSEMS was as a bridge to elective surgery in 23 patients and palliation in 26 patients. RESULTS Clinical success, defined as >50% dilatation of the stent with subsequent symptomatic improvement, was achieved in 48 of 49 patients (98%). The stent was properly inserted in all patients. No immediate major procedure-related complications occurred. One patient in the bridge-to-surgery group had colon perforation three days after DCSEMS application. Four patients had late migrations of the double stent. CONCLUSION Application of DCSEMS is safe and effective in management of malignant colonic obstruction; it prevents stent migration and tumor ingrowth and lowers perforation rate during the stent application. PMID:25698096

  11. Comparison of Endoscopic Vacuum Therapy and Endoscopic Stent Implantation With Self-Expandable Metal Stent in Treating Postsurgical Gastroesophageal Leakage

    PubMed Central

    Hwang, Jae J.; Jeong, Yeon S.; Park, Young S.; Yoon, Hyuk; Shin, Cheol M.; Kim, Nayoung; Lee, Dong H.

    2016-01-01

    Abstract The aim of the present study was to evaluate the more effective therapy for the postsurgical gastroesophageal leakage by a head-to-head comparison of endoscopic vacuum therapy (EVT) and endoscopic stent implantation with self-expandable metal stent (E-SEMS). In this hospital-based, retrospective, observative study, the patients were classified into 2 groups. Those treated with EVT were assigned to the EVT group (n = 7), and those treated with E-SMS were assigned to the E-SEMS group (n = 11). We evaluated the clinical characteristics and treatment outcomes between the 2 groups. All 7 patients (100%) were treated with EVT, but only 7 of 11 patients (63.6%) in the stenting group were treated successfully. The median time to clinical success was 19.5 (5–21) days in the EVT group and 27.0 (3–84) days in the E-SEMS group. The median hospital stay was 37.1 (13–128) days in the EVT group and 87.3 (17–366) days in the E-SEMS group. The complicaion rate was lower in the EVT group (0/7, 0.0%) than that in the E-SEMS group (6/11, 54.5%) with statistically significant difference (P = 0.042). EVT is more effective and has fewer adverse effects than E-SMS therapy as a treatment for postsurgical gastroesophageal leakage. PMID:27100431

  12. Comparison of Endoscopic Vacuum Therapy and Endoscopic Stent Implantation With Self-Expandable Metal Stent in Treating Postsurgical Gastroesophageal Leakage.

    PubMed

    Hwang, Jae J; Jeong, Yeon S; Park, Young S; Yoon, Hyuk; Shin, Cheol M; Kim, Nayoung; Lee, Dong H

    2016-04-01

    The aim of the present study was to evaluate the more effective therapy for the postsurgical gastroesophageal leakage by a head-to-head comparison of endoscopic vacuum therapy (EVT) and endoscopic stent implantation with self-expandable metal stent (E-SEMS). In this hospital-based, retrospective, observative study, the patients were classified into 2 groups. Those treated with EVT were assigned to the EVT group (n = 7), and those treated with E-SMS were assigned to the E-SEMS group (n = 11). We evaluated the clinical characteristics and treatment outcomes between the 2 groups. All 7 patients (100%) were treated with EVT, but only 7 of 11 patients (63.6%) in the stenting group were treated successfully. The median time to clinical success was 19.5 (5-21) days in the EVT group and 27.0 (3-84) days in the E-SEMS group. The median hospital stay was 37.1 (13-128) days in the EVT group and 87.3 (17-366) days in the E-SEMS group. The complicaion rate was lower in the EVT group (0/7, 0.0%) than that in the E-SEMS group (6/11, 54.5%) with statistically significant difference (P = 0.042). EVT is more effective and has fewer adverse effects than E-SMS therapy as a treatment for postsurgical gastroesophageal leakage.

  13. Safety and efficacy of self-expandable metallic stents in malignant small bowel obstructions

    PubMed Central

    Tsuboi, Akiyoshi; Kuwai, Toshio; Nishimura, Tomoyuki; Iio, Sumio; Mori, Takeshi; Imagawa, Hiroki; Yamaguchi, Toshiki; Yamaguchi, Atsushi; Kouno, Hirotaka; Kohno, Hiroshi

    2016-01-01

    In this report, we present 3 cases of malignant small bowel obstruction, treated with palliative care using endoscopic self-expandable metallic stent (SEMS) placement, with the aim to identify the safety and efficacy of this procedure. Baseline patient characteristics, procedure methods, procedure time, technical and clinical success rates, complications, and patient outcomes were obtained. All 3 patients had pancreatic cancer with small bowel strictures. One patient received the SEMS using colonoscopy, while the other 2 patients received SEMS placement via double balloon endoscopy using the through-the-overtube technique. The median procedure time was 104 min. The technical and clinical success rates were 100%. Post-treatment, obstructive symptoms in all patients improved, and a low-residue diet could be tolerated. All stents remained within the patients until their deaths. The median overall survival time (stent patency time) was 76 d. SEMS placement is safe and effective as a palliative treatment for malignant small bowel obstruction. PMID:27833393

  14. Finite element analysis of balloon-expandable coronary stent deployment: influence of angioplasty balloon configuration.

    PubMed

    Martin, David; Boyle, Fergal

    2013-11-01

    Today, the majority of coronary stents are balloon-expandable and are deployed using a balloon-tipped catheter. To improve deliverability, the membrane of the angioplasty balloon is typically folded about the catheter in a pleated configuration. As such, the deployment of the angioplasty balloon is governed by the material properties of the balloon membrane, its folded configuration and its attachment to the catheter. Despite this observation, however, an optimum strategy for modelling the configuration of the angioplasty balloon in finite element studies of coronary stent deployment has not been identified, and idealised models of the angioplasty balloon are commonly employed in the literature. These idealised models often neglect complex geometrical features, such as the folded configuration of the balloon membrane and its attachment to the catheter, which may have a significant influence on the deployment of a stent. In this study, three increasingly sophisticated models of a typical semi-compliant angioplasty balloon were employed to determine the influence of angioplasty balloon configuration on the deployment of a stent. The results of this study indicate that angioplasty balloon configuration has a significant influence on both the transient behaviour of the stent and its impact on the mechanical environment of the coronary artery.

  15. Small caliber covered self-expanding metal stents in the management of malignant dysphagia

    PubMed Central

    Kucera, Stephen; Barthel, James; Klapman, Jason; Shridhar, Ravi; Hoffe, Sarah; Harris, Cynthia; Almhanna, Khaldoun

    2016-01-01

    Background Use of large caliber [≥18 mm body diameter (BD)] self-expanding metal stents (SEMS) for management of malignant dysphasia is associated with substantial adverse event (AE) and mortality rates (MRs). We sought to determine dysphagia response, stent migration rates, and AE and MRs, for small caliber covered SEMS (sccSEMS) with BDs between 10–16 mm in malignant dysphagia. Methods Thirty-one patients underwent direct endoscopic placement of 50 sccSEMS between January 2008 and March 2011. Patients were monitored for change in dysphagia score (DS), stent migration, AEs, and death through May 2011. Results DS improved in 30 of 31 patients (97%). The median DS decreased from 3 to 2 (P<0.0001). The median effective duration of first sccSEMS placement was 116 (95% CI: 75–196) days. Major and minor AE rates were 6.5% and 19.4% respectively. No stent related deaths were encountered. The overall migration rate was 36% (18/50). The anticipated migration rate was 45.7% (16/35) and the unanticipated migration rate was 13.3% (2/15) (P=0.052). Positive effective clinical outcome occurred in 93.5% (29/31) of cases. Conclusions In malignant dysphagia, direct endoscopic sccSEMS placement provided acceptable dysphagia control and migration rates with substantial reductions in stent related AEs and MRs compared to those reported for large caliber SEMS. PMID:27284474

  16. Long-Term Results after Placement of Aortic Bifurcation Self-Expanding Stents: 10 Year Mortality, Stent Restenosis, and Distal Disease Progression

    SciTech Connect

    Houston, J. Graeme Bhat, Raj; Ross, Rose; Stonebridge, Peter A.

    2007-02-15

    Purpose. To retrospectively evaluate the 10 year follow-up results in patients who had 'kissing' self-expanding stent aortic bifurcation reconstruction. Methods. Forty-three patients were treated with 'kissing' self-expanding stents for aortoiliac occlusive disease. Early follow-up with clinical and ankle brachial pressure indices (ABPI) was performed at 3, 6, 12, and 24 months and with intra-arterial digital subtraction angiography at 12-24 months; clinical and angiographic follow-up was performed for symptom recurrence up to 10 years after treatment. Retrospective record review was performed to assess mortality, clinical patency, angiographic patency, and secondary assisted patency of both stents and downstream peripheral vessels at 5 and 10 years follow-up. Results. The 2 year primary angiographic and secondary assisted stent patencies were 89% and 93%, respectively. At 10 years follow-up in 40 patients the mortality was 38% (due to myocardial infarction, stroke, chronic renal failure, malignancy, and liver failure). At 5 and 10 years follow-up the primary clinical stent patency was 82% and 68%, and the secondary assisted stent patency 93% and 86%, respectively. At 5 and 10 years, the distal vessel patency was 86% and 72%, and the secondary assisted distal vessel patency treated by surgical or endovascular techniques was 94% and 88%, respectively. At 10 years there was no limb loss. Conclusion. The long-term (10 year) results of aortic bifurcation arterial self-expanding stent placement in patients with arterial occlusive disease show a 10 year primary stent patency rate of 68% but a secondary assisted patency rate of 86%. In addition there is a high overall mortality due to other cardiovascular causes and the rate of distal disease progression and loss of patency is similar to the loss of stent patency rate.

  17. Efficacy of laser photoablative therapy and expandable metal stents for esophageal carcinoma

    NASA Astrophysics Data System (ADS)

    Balachandar, Gowra; Trowers, Eugene A.

    2000-05-01

    Malignant dysphagia is a serious condition in which 70% of patients die within one year, regardless of the treatment received. It provokes a rapid deterioration of a patient's physical condition and a significant worsening of quality of life. The surgical treatment of dysphagia is frequently complicated with technical difficulties, and often the tumors cannot be excised because of extensive invasion into adjacent structures. Furthermore, many patients are considered inoperable due to advanced age, associated diseases and malnutrition. Laser photoablative therapy coupled with expandable metal stents restores luminal patency in more than 80% of patients allowing them to eat liquids and soft foods. The efficacy of laser photoablative therapy and expandable metal stents for the palliation esophageal carcinoma will be critically reviewed.

  18. Successful technical and clinical outcome using a second generation balloon expandable coronary stent for transplant renal artery stenosis: Our experience

    PubMed Central

    Salsamendi, Jason; Pereira, Keith; Baker, Reginald; Bhatia, Shivank S; Narayanan, Govindarajan

    2015-01-01

    Transplant renal artery stenosis (TRAS) is a vascular complication frequently seen because of increase in the number of renal transplantations. Early diagnosis and management is essential to optimize a proper graft function. Currently, the endovascular treatment of TRAS using angioplasty and/or stenting is considered the treatment of choice with the advantage that it does not preclude subsequent surgical correction. Treatment of TRAS with the use of stents, particularly in tortuous transplant renal anatomy presents a unique challenge to an interventional radiologist. In this study, we present three cases from our practice highlighting the use of a balloon-expandable Multi-Link RX Ultra coronary stent system (Abbott Laboratories, Abbott Park, Illinois, USA) for treating high grade focal stenosis along very tortuous renal arterial segments. Cobalt–Chromium alloy stent scaffold provides excellent radial force, whereas the flexible stent design conforms to the vessel course allowing for optimal stent alignment. PMID:26629289

  19. Endosonography-guided drainage of malignant fluid collections using lumen-apposing, fully covered self-expanding metal stents.

    PubMed

    Musumba, Crispin; Tutticci, Nicholas; Nanda, Kavinderjit; Kwan, Vu

    2014-08-01

    Endosonography (EUS)-guided drainage of paragastric fluid collections using fully covered self-expanding metal stents (FCSEMS) is now a well-established procedure. Recently, new and specially designed lumen-apposing, fully-covered metal cystgastrostomy stents have been employed for this indication. In this case series, the use of these new stents for the drainage of malignant fluid collections in three symptomatic patients is described. Cases included a large pancreatic pseudocyst, secondary to underlying acute lymphoblastic leukemia, and two large collections of loculated ascites due to metastatic ovarian and cervical cancer, respectively. Technical success in inserting the new stents was achieved in all three patients, and resulted in symptomatic relief. There were no clinically significant complications directly attributed to the stents. These new lumen-apposing cystgastrostomy stents may provide a viable, minimally invasive, and effective alternative for drainage of malignant fluid collections, either for definitive treatment or for palliation of symptoms.

  20. Mechanical Interaction of an Expanding Coiled Stent with a Plaque-Containing Arterial Wall: A Finite Element Analysis.

    PubMed

    Welch, Tré R; Eberhart, Robert C; Banerjee, Subhash; Chuong, Cheng-Jen

    2016-03-01

    Wall injury is observed during stent expansion within atherosclerotic arteries, related in part to stimulation of the inflammatory process. Wall stress and strain induced by stent expansion can be closely examined by finite element analysis (FEA), thus shedding light on procedure-induced sources of inflammation. The purpose of this work was to use FEA to examine the interaction of a coiled polymer stent with a plaque-containing arterial wall during stent expansion. An asymmetric fibrotic plaque-containing arterial wall model was created from intravascular ultrasound (IVUS) images of a diseased artery. A 3D model for a coil stent at unexpanded state was generated in SolidWorks. They were imported into ANSYS for FEA of combined stent expansion and fibrotic plaque-distortion. We simulated the stent expansion in the plaqued lumen by increasing balloon pressure from 0 to 12 atm in 1 atm step. At increasing pressure, we examined how the expanding stent exerts forces on the fibrotic plaque and vascular wall components, and how the latter collectively resist and balance the expansive forces from the stent. Results show the expanding coiled stent creates high stresses within the plaque and the surrounding fibrotic capsule. Lower stresses were observed in adjacent medial and adventitial layers. High principal strains were observed in plaque and fibrotic capsule. The results suggest fibrotic capsule rupture might occur at localized regions. The FEA/IVUS method can be adapted for routine examination of the effects of the expansion of selected furled stents against IVUS-reconstructed diseased vessels, to improve stent deployment practices.

  1. Iliocaval Confluence Stenting for Chronic Venous Obstructions

    SciTech Connect

    Graaf, Rick de; Wolf, Mark de; Sailer, Anna M.; Laanen, Jorinde van Wittens, Cees; Jalaie, Houman

    2015-10-15

    PurposeDifferent techniques have been described for stenting of venous obstructions. We report our experience with two different confluence stenting techniques to treat chronic bi-iliocaval obstructions.Materials and MethodsBetween 11/2009 and 08/2014 we treated 40 patients for chronic total bi-iliocaval obstructions. Pre-operative magnetic resonance venography showed bilateral extensive post-thrombotic scarring in common and external iliac veins as well as obstruction of the inferior vena cava (IVC). Stenting of the IVC was performed with large self-expandable stents down to the level of the iliocaval confluence. To bridge the confluence, either self-expandable stents were placed inside the IVC stent (24 patients, SECS group) or high radial force balloon-expandable stents were placed at the same level (16 patients, BECS group). In both cases, bilateral iliac extensions were performed using nitinol stents.ResultsRecanalization was achieved for all patients. In 15 (38 %) patients, a hybrid procedure with endophlebectomy and arteriovenous fistula creation needed to be performed because of significant involvement of inflow vessels below the inguinal ligament. Mean follow-up was 443 ± 438 days (range 7–1683 days). For all patients, primary, assisted-primary, and secondary patency rate at 36 months were 70, 73, and 78 %, respectively. Twelve-month patency rates in the SECS group were 85, 85, and 95 % for primary, assisted-primary, and secondary patency. In the BECS group, primary patency was 100 % during a mean follow-up period of 134 ± 118 (range 29–337) days.ConclusionStenting of chronic bi-iliocaval obstruction shows relatively high patency rates at medium follow-up. Short-term patency seems to favor confluence stenting with balloon-expandable stents.

  2. A finite element study of balloon expandable stent for plaque and arterial wall vulnerability assessment

    NASA Astrophysics Data System (ADS)

    Karimi, Alireza; Navidbakhsh, Mahdi; Razaghi, Reza

    2014-07-01

    The stresses induced within plaque tissues and arterial layers during stent expansion inside an atherosclerotic artery can be exceeded from the yield stresses of those tissues and, consequently, lead to plaque or arterial layer rupture. The distribution and magnitude of the stresses in each component involved in stenting might be clearly different for different plaque types and different arterial layers. In this study, a nonlinear finite element simulation was employed to investigate the effect of plaque composition (calcified, cellular, and hypocellular) on the stresses induced in the arterial layers (intima, media, and adventitia) during implantation of a balloon expandable coronary stent into a stenosed artery. The atherosclerotic artery was assumed to consist of a plaque and normal/healthy arterial tissues on its outer side. The results indicated a significant influence of plaque types on the maximum stresses induced within the plaque wall and arterial layers during stenting but not when computing maximum stress on the stent. The stress on the stiffest calcified plaque wall was in the fracture level (2.38 MPa), whereas cellular and hypocellular plaques remain stable owing to less stress on their walls. Regardless of plaque types, the highest von Mises stresses were observed on the stiffest intima layer, whereas the lowest stresses were seen to be located in less stiff media layer. The computed stresses on the intima layer were found to be high enough to initiate a rupture in this stiff layer. These findings suggest a higher risk of arterial vascular injury for the intima layer, while a lower risk of arterial injury for the media and adventitia layers.

  3. Finite Element Modeling of A Novel Self-Expanding Endovascular Stent Method in Treatment of Aortic Aneurysms

    NASA Astrophysics Data System (ADS)

    Arokiaraj, Mark C.; Palacios, Igor F.

    2014-01-01

    A novel large self-expanding endovascular stent was designed with strut thickness of 70 μm × 70 μm width. The method was developed and investigated to identify a novel simpler technique in aortic aneurysm therapy. Stage 1 analysis was performed after deploying it in a virtual aneurysm model of 6 cm wide × 6 cm long fusiform hyper-elastic anisotropic design. At cell width of 9 mm, there was no buckling or migration of the stent at 180 Hg. Radial force of the stents was estimated after parametric variations. In stage 2 analysis, a prototype 300 μm × 150 μm stent with a cell width of 9 mm was chosen, and it was evaluated similarly after embedding in the aortic wall, and also with a tissue overgrowth of 1 mm over the stent. The 300/150 μm stent reduced the peak wall stress by 70% in the aneurysm and 50% reduction in compliance after embedding. Stage 3 analysis was performed to study the efficacy of stents with struts (thickness/width) 70/70, 180/100 and 300/150 μm after embedding and tissue overgrowth. The adjacent wall stresses were very minimal in stents with 180/100 and 70/70 μm struts after embedding. There is potential for a novel stent method in aortic aneurysm therapy.

  4. Self-Expanding Metal Stenting in the Management of a Benign Colonic Stricture

    PubMed Central

    Jessamy, Kegan; Ozden, Nuri; Simon, Howard M.; Kobrossi, Semaan; Ubagharaji, Ezinnaya

    2016-01-01

    Colonic postanastomotic strictures occur in 1.5–8% of patients following colorectal surgery. Traditionally, colonic strictures were treated by multiple modalities including endoscopic dilatation. Self-expanding metal stents (SEMS) have been indicated in the management of benign colonic strictures; however, there are limited available data with regard to their efficacy. We present the case of a 68-year-old male who had perforated sigmoid diverticulitis followed by Hartmann's procedure with eventual reanastomosis 6 months later. He subsequently developed benign colonic stricture, which was treated with a metal stent. SEMS are associated with a low mortality rate and are appropriate in treating acute colonic obstruction as a result of benign stricture in the setting of postanastomosis. PMID:27403114

  5. A Comparative Biocompatibility Analysis of Ternary Nitinol Alloys

    PubMed Central

    Haider, Waseem; Munroe, Norman; Pulletikurthi, Chandan; Singh Gill, Puneet K.; Amruthaluri, Sushma

    2009-01-01

    Nitinol alloys are rapidly being utilized as the material of choice in a variety of applications in the medical industry. It has been used for self-expanding stents, graft support systems, and various other devices for minimally invasive interventional and endoscopic procedures. However, the biocompatibility of this alloy remains a concern to many practitioners in the industry due to nickel sensitivity experienced by many patients. In recent times, several new Nitinol alloys have been introduced with the addition of a ternary element. Nevertheless, there is still a dearth of information concerning the biocompatibility and corrosion resistance of these alloys. This study compared the biocompatibility of two ternary Nitinol alloys prepared by powder metallurgy (PM) and arc melting (AM) and critically assessed the influence of the ternary element. ASTM F 2129-08 cyclic polarization in vitro corrosion tests were conducted to evaluate the corrosion resistance in phosphate buffered saline (PBS). The growth of endothelial cells on NiTi was examined using optical microscopy. PMID:19956791

  6. A fully covered self-expandable metal stent anchored by a 10-Fr double pigtail plastic stent: an effective anti-migration technique

    PubMed Central

    Katsinelos, Panagiotis; Lazaraki, Georgia; Gkagkalis, Stergios; Chatzimavroudis, Grigoris; Anastasiadou, Kiriaki; Georgakis, Nikos; Giouleme, Olga; Zavos, Christos; Kountouras, Jannis

    2017-01-01

    Background Fully covered self-expandable metal stents (FCSEMS) have been used successfully in the treatment of malignant and benign biliary strictures. However, stent migration is a major complication. We investigated the efficacy of anchoring FCSEMS with a 10-Fr double-pigtail plastic stent to prevent migration in patients with biliary strictures. Methods Between January 2012 and May 2013, 10 patients with malignant biliary strictures and one patient with a suprapapillary benign biliary stenosis were enrolled in the study. The primary endpoint of the study was to record the migration rate of FCSEMS. Results The placement of FCSEMSs and the anchoring with a 10-Fr double-pigtail plastic stent were successful in all patients. During a median follow-up period of eight months, proximal or distal migration of FCSEMS was not observed. No procedural complications related to the placement of FCSEMS and/or the anchoring plastic stent were recorded. Conclusions The placement of an anchoring 10-Fr double-pigtail stent is a simple and effective anti-migration technique for FCSEMS in patients with malignant biliary strictures. PMID:28042247

  7. Prevention of Intracranial In-stent Restenoses: Predilatation with a Drug Eluting Balloon, Followed by the Deployment of a Self-Expanding Stent

    SciTech Connect

    Vajda, Zsolt Guethe, Thomas Perez, Marta Aguilar Kurre, Wiebke; Schmid, Elisabeth Baezner, Hansjoerg; Henkes, Hans

    2013-04-15

    Stenting in intracranial atherosclerotic disease (ICAD) is increasingly debated, due to issues of procedural safety, technical efficacy, and in-stent recurrent stenoses (ISR). In the present study, feasibility, safety, and efficacy of angioplasty using a drug-eluting balloon (DEB) followed by the implantation of a self-expanding stent (Enterprise) were evaluated for the treatment of ICAD lesions. Fifty-two patients (median age: 71 years; range: 54-86 years; male/female ratio 37:15) underwent stenting of high-grade ICAD lesions between February 2010 and November 2011 in a single center. Angioplasty using a paclitaxel coated SeQuent Please (B. Braun, Germany) or DIOR (Eurocor, Germany) coronary PTCA balloon, followed by the implantation of a self-expanding stent (Enterprise, Codman, USA) was performed in 54 lesions. Angiographic and clinical follow-up was performed at 6 and 12 weeks, 6 and 12 months, and yearly thereafter. Technical success rate, periprocedural complications, occurrence of recurrent ischemic symptoms, and the development of an ISR were analyzed. Angioplasty using a DEB followed by stent implantation was successfully performed in 44 (81 %) cases. DEB insertion failed in 19 % of the cases and angioplasty was finally performed using a conventional PTCA balloon. The combined procedure related permanent neurologic morbidity and mortality rate (stroke, ICH, and subarachnoid hemorrhage) at 30 days and beyond was 5 %. Angiographic and clinical follow-up were obtained in 33 (61 %) lesions in 32 patients. Recurrent stenosis was seen in one (3 %) lesion. Angioplasty and stenting using a DEB is safe and yields encouragingly low ISR rates. Further technical developments to improve lesion accessibility are, nevertheless, mandatory.

  8. Biodegradable shape-memory block co-polymers for fast self-expandable stents.

    PubMed

    Xue, Liang; Dai, Shiyao; Li, Zhi

    2010-11-01

    Block co-polymers PCTBVs (M(n) of 36,300-65,300 g/mol, T(m) of 39-40 and 142 degrees C) containing hyperbranched three-arm poly(epsilon-caprolactone) (PCL) as switching segment and microbial polyester PHBV as crystallizable hard segment were designed as biodegradable shape-memory polymer (SMP) for fast self-expandable stent and synthesized in 96% yield by the reaction of three-arm PCL-triol (M(n) of 4200 g/mol, T(m) of 47 degrees C) with methylene diphenyl 4,4'-diisocyanate isocynate (MDI) to form the hyperbrached MDI-linked PCL (PTCM; M(n) of 25,400 g/mol and a T(m) of 38 degrees C), followed by further polymerization with PHBV-diol (M(n) of 2200 g/mol, T(m) of 137 and 148 degrees C). The polymers were characterized by (1)H NMR, GPC, DSC, tensile test, and cyclic thermomechanical tensile test. PCTBVs showed desired thermal properties, mechanical properties, and ductile nature. PCTBV containing 25 wt% PHBV (PCTBV-25) demonstrated excellent shape-memory property at 40 degrees C, with R(f) of 94%, R(r) of 98%, and shape recovery within 25s. PCTBV-25 was also shown as a safe material with good biocompatibility by cytotoxicity tests and cell growth experiments. The stent made from PCTBV-25 film showed nearly complete self-expansion at 37 degrees C within only 25 s, which is much better and faster than the best known self-expandable stents.

  9. Bronchoscopic management of critical central airway obstruction by thyroid cancer: Combination airway stenting using tracheal and inverted-Y carinal self-expanding metallic stents

    PubMed Central

    Madan, Karan; Shrestha, Prajowl; Garg, Rakesh; Hadda, Vijay; Mohan, Anant; Guleria, Randeep

    2017-01-01

    Central airway obstruction (CAO) can result from various benign and malignant etiologies. Anaplastic thyroid cancer (ATC) is the most aggressive form of thyroid cancer. Rapid airway compromise is the main cause of death in ATC. We report a patient with ATC who presented with a large neck mass leading to CAO with long segment tracheal and right main bronchial compression and respiratory failure. Urgent Rigid Bronchoscopy was performed for airway stabilization and patient was managed with a combination airway stenting approach. A combination of self expanding, metallic, covered inverted Y and straight tracheal stents was used to stabilize the near complete airway structure. We herein highlight the role of therapeutic rigid bronchoscopy with airway stenting as an efficacious treatment modality for management of malignant CAO. PMID:28360477

  10. Arterial bleeding during EUS-guided pseudocyst drainage stopped by placement of a covered self-expandable metal stent

    PubMed Central

    2013-01-01

    Background Hemorrhagic complications during EUS-guided pseudocyst drainage can occur, because the vessels on the internal wall of the pseudocyst might be compressed by the fluid and thus not visible on color Doppler or even power Doppler EUS. Case presentation We report a case of an immediate internal spurting arterial bleeding precipitated during EUS-guided pseudocyst drainage which stopped instantaneously by placement of a double flanged covered self-expandable metal stent through mechanical hemostasis. Conclusion In an unusual situation of bleeding from collateral circulation near the pseudocyst wall during pseudocyst drainage, the placement of an expandable metal stent proved to be useful. PMID:23706101

  11. Use of expanded polytetrafluoroethylen (ePTFE) stent graft in autogenic AV fistula with false aneurysm in lower extremity.

    PubMed

    Sieroń, Dominik; Wiggermann, Philipp; Knap, Daniel; Wawrzynek, Wojciech; Stroszczynski, Christian

    2012-04-01

    A 28-year-old German-Caucasian man arrived with deep vein thrombosis DVT, pain, oedema and rubor of right lower limb and drug abuse. The US Doppler imaging showed an autogenic AV fistula and false aneurysm of the right superficial femoral artery and femoral vein. The CT imaging showed additional closing of the left external iliac artery and common femoral artery, and of the distal and middle parts of the superficial femoral artery. The patient was treated within the angiography suite using a 8/25 mm (8 mm diameter/25 mm length) peripheral graft with expanded polytetrafluoroethylen ePTFE stent. After stent deployment, the dilatation was performed using 8/20 mm (8 mm diameter/20 mm length) balloons. After intervention, the digital subtraction angiography showed a good stent position with complete exclusion of false aneurysm and AV fistula. The outcome of US Doppler imaging also confirmed successful intervention.

  12. Palliation of Obstructing Malignant Colonic Lesions Using Self-Expanding Metal Stents: A Single-Center Experience

    SciTech Connect

    Shrivastava, Vivek; Tariq, Omar; Tiam, ReeNee; Nyhsen, Christiane; Marsh, Ralph

    2008-09-15

    To evaluate the efficacy, risks, and survival after palliative colorectal stenting at a single center, we conducted a retrospective review of consecutive patients who had colorectal self-expanding metal stents (SEMSs) inserted over an 8-year period (September 1998 to September 2006) to relieve an obstructing colorectal tumor. All patients either had proven distant metastases or were unfit for surgical decompression. A single interventional radiologist (R.M.) inserted the stents, which were either Memotherm or WallFlex. Ninety-one patients with a median age of 73 years had a colorectal stent inserted for palliation of an obstructing colorectal malignancy. Technical success was achieved in 81 of 91 (89%) patients, and clinical success in 80 of 81 (99%). At the time of analysis (December 2006), 13 of 91 (14.2%) patients were alive. The patients who died had a median survival of 59 days, IQR 17-181 days. Seven (7/81) patients suffered stent migration, which occurred 10.3 days (IQR, 5-14 days) after the procedure. Three patients (3/81) re-presented with intestinal obstruction secondary to tumor ingrowth and 10 (10.9%) patients suffered bowel perforation. Ten patients (10.9%) had two stents inserted coaxially and overlapping in one procedure. This was performed in cases where the stricture was too long to be easily crossed by a single stent. We conclude that colorectal SEMS is a safe and effective mode of treatment for the palliation of obstructing colorectal cancers, which avoids high-risk surgery.

  13. Leo Stent for Endovascular Treatment of Broad-Necked and Fusiform Intracranial Aneurysms

    PubMed Central

    Juszkat, R.; Nowak, S.; Smól, S.; Kociemba, W.; Blok, T.; Zarzecka, A.

    2007-01-01

    Summary The advent of intracranial stents has widened the indications for endovascular treatment of broad-necked and fusiform aneurysms. Leo stent is a self-expandable, nitinol, braided stent dedicated to intracranial vessels. The aim of this study is to present our experience in endovascular treatment of broad-necked and fusiform intracranial aneurysms using self-expanding, nitinol Leo stents. Between February 2004 and November 2006, 25 broad-necked and three fusiform aneurysms in 28 patients were treated using Leo stents in our centre. There were 18 patients who experienced acute subarachnoid haemorrhage due to aneurysm rupture, two patients who experienced SAH at least 12 months ago and in eight patients aneurysms were found incidentally. Aneurysms were located as follows: internal carotid artery15, basilar artery5, basilar tip3, posterior inferior cerebral artery2, M1/M2 segment1, A2 segment1 and vertebral artery1. There were no difficulties with stent deployment and delivery. All patients after acute SAH (n=18) underwent stent implantation and coil embolization in one procedure. The remaining patients underwent coil embolization in a staged procedure. Immediate aneurysm occlusion of more than 95% was achieved in all patients who underwent stent placement and coil embolization in one procedure. There were three thromboembolic complications encountered in patients in an acute setting of SAH, preloaded only on acetylsalicylic acid. Use of abciximab led to patency within the stent and parent vessel. However, one of these patients presented rebleeding from the aneurysm during administration of abciximab and died. Application of Leo stents in cases of broadnecked and fusiform intracranial aneurysms is safe and effective with a low complication rate. PMID:20566117

  14. An overview of thin film nitinol endovascular devices.

    PubMed

    Shayan, Mahdis; Chun, Youngjae

    2015-07-01

    Thin film nitinol has unique mechanical properties (e.g., superelasticity), excellent biocompatibility, and ultra-smooth surface, as well as shape memory behavior. All these features along with its low-profile physical dimension (i.e., a few micrometers thick) make this material an ideal candidate in developing low-profile medical devices (e.g., endovascular devices). Thin film nitinol-based devices can be collapsed and inserted in remarkably smaller diameter catheters for a wide range of catheter-based procedures; therefore, it can be easily delivered through highly tortuous or narrow vascular system. A high-quality thin film nitinol can be fabricated by vacuum sputter deposition technique. Micromachining techniques were used to create micro patterns on the thin film nitinol to provide fenestrations for nutrition and oxygen transport and to increase the device's flexibility for the devices used as thin film nitinol covered stent. In addition, a new surface treatment method has been developed for improving the hemocompatibility of thin film nitinol when it is used as a graft material in endovascular devices. Both in vitro and in vivo test data demonstrated a superior hemocompatibility of the thin film nitinol when compared with commercially available endovascular graft materials such as ePTFE or Dacron polyester. Promising features like these have motivated the development of thin film nitinol as a novel biomaterial for creating endovascular devices such as stent grafts, neurovascular flow diverters, and heart valves. This review focuses on thin film nitinol fabrication processes, mechanical and biological properties of the material, as well as current and potential thin film nitinol medical applications.

  15. Analytical Models for Predicting Mechanical Properties of Self-Expandable Metal Stents with Cover Membrane

    DTIC Science & Technology

    2007-11-02

    compressed, it elongates in its longitudinal direction. Consider the deformation of parallelogram cell as shown in Fig. 4(A). When the points A, B, and...the cell maintains a parallelogram shape during compression. The length between A and B of uncompressed stent is N klL wireAB 0 sin2 β= (14...Expansive pressure- deformation curve for bare type stent. 8 10 12 14 16 0 4 8 12 16 Experiments Pbare Pcoat Pcoated stent

  16. Stent-Assisted Coil Embolization of a Mycotic Renal Artery Aneurysm by Use of a Self-Expanding Neurointerventional Stent

    SciTech Connect

    Rabellino, Martin; Garcia-Nielsen, Luis; Zander, Tobias Baldi, Sebastian; Llorens, Rafael; Maynar, Manuel

    2011-02-15

    Mycotic aneurysms are uncommon, especially those located in visceral arteries. We present a case of a patient with two visceral mycotic aneurysms due to bacterial endocarditis, one located in right upper pole renal artery and the second in the splenic artery. Both aneurysms were treated as endovascular embolization using microcoils. In the aneurysm located at the renal artery, the technique of stent-assisted coils embolization was preferred to avoid coils migration due to its wide neck. The stent used was the Solitaire AB, which was designed for the treatment of intracranial aneurysms and was used recently in acute stroke as a mechanical thrombectomy device. Complete embolization of the aneurysm was achieved, preserving all the arterial branches without nephrogram defects in the final angiogram.

  17. Drug-Eluting Nitinol Stent Treatment of the Superficial Femoral Artery and Above-the-Knee Popliteal Artery (The Zilver PTX Single-Arm Clinical Study): A Comparison Between Diabetic and Nondiabetic Patients

    SciTech Connect

    Fanelli, Fabrizio; Primo, Massimiliano Di; Boatta, Emanuele; Johnston, Krystal; Sapoval, Marc

    2013-10-15

    Purpose: To describe the 1-year results of drug-eluting nitinol stent placement in the femoropopliteal artery of diabetic and nondiabetic patients. Materials and Methods: All patients enrolled in this prospective, multicenter study underwent paclitaxel-eluting stent placement for de novo or restenotic lesions of the superficial femoral and/or popliteal artery. Baseline and follow-up walking impairment questionnaire (WIQ) scores, Rutherford classifications, and ankle-brachial index (ABI) measurements were obtained. Follow-up was completed at 1, 6, and 12 months. Results: There were 285 diabetic patients and 502 nondiabetic patients treated. There were no significant differences in mean lesion length or lesion calcification between patient groups. Procedural success in both treatment groups was >97 %. There were no significant differences between diabetic and nondiabetic groups in Kaplan-Meier estimates of patency, event-free survival (EFS), or freedom from target lesion revascularization (TLR) at 6 and 12 months. Both groups experienced a significant increase in ABI and WIQ values after treatment, and these improvements were sustained to 12-month follow-up; however, nondiabetic patients had significantly greater 6- and 12-month WIQ scores compared with diabetic patients. Based on covariate analysis, the only factors shown to be significant and to negatively influence patency were longer lesion length (p = 0.009), higher Rutherford classification (p = 0.02), and lack of hypertension (p = 0.02); diabetic status was not found to be a significant factor. Conclusion: Diabetic and nondiabetic patients had similar estimates of primary patency, EFS, and freedom from TLR; however, diabetic patients showed less improvement in WIQ scores compared with nondiabetic patients.

  18. Stent-Assisted Clip Placement for Complex Internal Carotid Artery Intracranial Aneurysms

    PubMed Central

    Qureshi, Adnan I.; Chughtai, Morad; Khan, Asif A.; Suri, M. Fareed K.; Sherr, Gregory T.

    2016-01-01

    BACKGROUND We report two procedures using a stent-assisted microsurgical clip placement to treat complex intracranial aneurysms originating from supraclinoid segment of the internal carotid artery. CASE DESCRIPTIONS In both procedures, primary clip placement was considered technically difficult due to either complex morphology or inferior protrusion of aneurysm fundus within the interclinoid space. A nitinol self-expanding stent was placed across the neck of the aneurysm either preoperatively or intraoperatively. Obliteration of aneurysm and patency of the artery was confirmed by angiography after clip placement. CONCLUSION Description of an integrated open microsurgical and endovascular approach and review of literature pertaining to considerations for treatment approach are discussed. PMID:26958150

  19. Are Carotid Stent Fractures Clinically Significant?

    SciTech Connect

    Garcia-Toca, Manuel; Rodriguez, Heron E.; Naughton, Peter A.; Keeling, Aiofee; Phade, Sachin V.; Morasch, Mark D.; Kibbe, Melina R.; Eskandari, Mark K.

    2012-04-15

    Purpose: Late stent fatigue is a known complication after carotid artery stenting (CAS) for cervical carotid occlusive disease. The purpose of this study was to determine the prevalence and clinical significance of carotid stent fractures. Materials and Methods: A single-center retrospective review of 253 carotid bifurcation lesions treated with CAS and mechanical embolic protection from April 2001 to December 2009 was performed. Stent integrity was analyzed by two independent observers using multiplanar cervical plain radiographs with fractures classified into the following types: type I = single strut fracture; type II = multiple strut fractures; type III = transverse fracture; and type IV = transverse fracture with dislocation. Mean follow-up was 32 months. Results: Follow-up imaging was completed on 106 self-expanding nitinol stents (26 closed-cell and 80 open-cell stents). Eight fractures (7.5%) were detected (type I n = 1, type II n = 6, and type III n = 1). Seven fractures were found in open-cell stents (Precise n = 3, ViVEXX n = 2, and Acculink n = 2), and 1 fracture was found in a closed-cell stent (Xact n = 1) (p = 0.67). Only a previous history of external beam neck irradiation was associated with fractures (p = 0.048). No associated clinical sequelae were observed among the patients with fractures, and only 1 patient had an associated significant restenosis ({>=}80%) requiring reintervention. Conclusions: Late stent fatigue after CAS is an uncommon event and rarely clinically relevant. Although cell design does not appear to influence the occurrence of fractures, lesion characteristics may be associated risk factors.

  20. A thin film nitinol heart valve.

    PubMed

    Stepan, Lenka L; Levi, Daniel S; Carman, Gregory P

    2005-11-01

    In order to create a less thrombogenic heart valve with improved longevity, a prosthetic heart valve was developed using thin film nitinol (NiTi). A "butterfly" valve was constructed using a single, elliptical piece of thin film NiTi and a scaffold made from Teflon tubing and NiTi wire. Flow tests and pressure readings across the valve were performed in vitro in a pulsatile flow loop. Bio-corrosion experiments were conducted on untreated and passivated thin film nitinol. To determine the material's in vivo biocompatibility, thin film nitinol was implanted in pigs using stents covered with thin film NiTi. Flow rates and pressure tracings across the valve were comparable to those through a commercially available 19 mm Perimount Edwards tissue valve. No signs of corrosion were present on thin film nitinol samples after immersion in Hank's solution for one month. Finally, organ and tissue samples explanted from four pigs at 2, 3, 4, and 6 weeks after thin film NiTi implantation appeared without disease, and the thin film nitinol itself was without thrombus formation. Although long term testing is still necessary, thin film NiTi may be very well suited for use in artificial heart valves.

  1. Present and future of endovascular SFA treatment: stents, stent-grafts, drug coated balloons and drug coated stents.

    PubMed

    Bosiers, M; Deloose, K; Verbist, J; Peeters, P

    2008-04-01

    The current evolution towards treating more complex femoropopliteal lesions as seen in the renewed TASC II recommendations clearly reflects the continuous evolutions in femoropopliteal stent design. Recent stent design improvements focus on decreasing stent fractures rates which can negatively impact patency rates. By rearranging strut alignment towards helical connecting bridges or full helical stent designs, stent designers have successfully improved the fracture resistance of their stents. The superior fracture resistance of the latest stent generation in combination with the production of long nitinol stents of up to 20 cm in length allow that more difficult and complex lesions can be treated endovascularly. The continuous perfection of nitinol stent platforms followed by the transfer of coronary technologies (e.g. active coatings) towards peripheral devices might broaden the indications for the minimal invasive strategy towards TransAtlantic Inter-Society Consensus (TASC) II C&D lesions.

  2. Corrosion Behavior of Platinum-Enhanced Radiopaque Stainless Steel (PERSS®) for Dilation-Baloon Expandable Coronary Stents

    SciTech Connect

    Covino, Jr., Bernard S.; Craig, Charles H.; Cramer, Stephen D.; Bullard, Sophie J.; Ziomek-Moroz, Margaret; Jablonski, Paul D.; Turner, Paul C.; Radisch, Jr., Herbert R.; Gokcen, Nev A.; Friend, Clifford M.; Edwards, Michael R.

    2002-05-01

    Dilation-balloon expandable coronary stents are commonly made of implant grade stainless steels conforming to ASTM F138/F139, e.g., Biodur? 316LS (UNS S31673). Typical of such stents is the Boston Scientific/Interventional Technologies? (BS/IVT) LP-StentTM. In 2000, BS/IVT determined that the addition of 5 to 6 wt % platinum to Biodur 316LS produced a stainless steel with enhanced radiopacity to make their stents more visible radiographically and thus more effective clinically. A goal of the program was to ensure platinum additions would not adversely affect the corrosion resistance of Biodur 316LS. The corrosion resistance of 5-6 wt % PERSS? alloys and Biodur 316LS was determined using electrochemical tests for general, pitting, crevice and intergranular corrosion. Experimental methods included ASTM A262E, F746, F2129, and potentiodynamic polarization. The 6 wt % PERSS? alloy (IVT 78) had a resistance to pitting, crevice and intergranular corrosion that was similar to the Biodur 316LS base material. IVT 78 was a single-phase austenitic alloy with no evidence of inclusions or precipitates. It was more resistant to pitting corrosion than 5 wt % PERSS? alloys. Performance of the PERSS? alloys was not a function of alloy oxygen content in the range 0.01 to 0.03 wt %.

  3. Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.

    PubMed

    van Hooft, Jeanin E; van Halsema, Emo E; Vanbiervliet, Geoffroy; Beets-Tan, Regina G H; DeWitt, John M; Donnellan, Fergal; Dumonceau, Jean-Marc; Glynne-Jones, Robert G T; Hassan, Cesare; Jiménez-Perez, Javier; Meisner, Søren; Muthusamy, V Raman; Parker, Michael C; Regimbeau, Jean-Marc; Sabbagh, Charles; Sagar, Jayesh; Tanis, Pieter J; Vandervoort, Jo; Webster, George J; Manes, Gianpiero; Barthet, Marc A; Repici, Alessandro

    2014-11-01

    This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). This Guideline was also reviewed and endorsed by the Governing Board of the American Society for Gastrointestinal Endoscopy (ASGE). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations The following recommendations should only be applied after a thorough diagnostic evaluation including a contrast-enhanced computed tomography (CT) scan. 1 Prophylactic colonic stent placement is not recommended. Colonic stenting should be reserved for patients with clinical symptoms and imaging evidence of malignant large-bowel obstruction, without signs of perforation (strong recommendation, low quality evidence). 2 Colonic self-expandable metal stent (SEMS) placement as a bridge to elective surgery is not recommended as a standard treatment of symptomatic left-sided malignant colonic obstruction (strong recommendation, high quality evidence). 3 For patients with potentially curable but obstructing left-sided colonic cancer, stent placement may be considered as an alternative to emergency surgery in those who have an increased risk of postoperative mortality, I. e. American Society of Anesthesiologists (ASA) Physical Status ≥ III and/or age > 70 years (weak recommendation, low quality evidence). 4 SEMS placement is recommended as the preferred treatment for palliation of malignant colonic obstruction (strong recommendation, high quality evidence), except in patients treated or considered for treatment with antiangiogenic drugs (e. g. bevacizumab) (strong recommendation, low quality evidence).

  4. Self-expanding metal mesh stents and laser therapy: a complementary approach for the palliation of malignant dysphagia

    NASA Astrophysics Data System (ADS)

    Madhotra, Ravi; Raouf, A.; Sturgess, R.; Krasner, Neville

    1997-12-01

    Re-establishment of the oesophageal lumen is the main focus of care in patients with inoperable oesophageal carcinomas. The self-expanding metal mesh stents (MMS) are increasingly being used. 51 patients aged 44 - 89 with inoperable oesophago-gastric carcinomas were intubated with MMS. 18 of these patients had endoscopic laser therapy (ELT) as primary palliation. 25 patients required follow-up endoscopy at variable intervals after stent insertion. 17 patients were found to have significant tumor growth (9), overgrowth (4) and both (4). All these patients were treated with Nd:YAG or diode laser for maintenance of satisfactory swallowing. 4 patients being treated with Nd:YAG laser developed deformity of MMS. This complication was not encountered with diode laser. The reblockage of MMS due to ingrowth or overgrowth of tumor is a not uncommon complication. The timing of the stent insertion should be carefully chosen since the longer the stent is in situ, the greater is the likelihood of tumor ingrowth or overgrowth. ELT can effectively deal with tumor ingrowth and overgrowth. Nd:YAG laser can cause melting of MMS. Overall the combination of ELT and MMS may offer the best palliation, particularly when patient survival of several months is anticipated.

  5. Self-Expanding Metal Stents for Palliative Treatment of Superior Vena Caval Syndrome

    SciTech Connect

    Oudkerk, Matthijs; Kuijpers, Theodore J.A.

    1996-05-15

    Purpose: Two stent types (a new Wallstent and a Z-stent) were investigated in 30 patients with recurrent malignant superior vena caval syndrome (SVCS). Methods: Eligibility requirements were that the patient had recurrent symptoms after appropriate radiation therapy, chemotherapy, or both; {>=}75% of the vessel was occluded; and there was collateral flow. Because of the limited availability of stents, it was not possible to perform a prospectively randomized study. Results: In the Z-stent group (17 patients), occlusion of the stent due to acute thrombosis occurred within 12 hr in 4 patients (24%), but in the other 13 patients (76%) symptoms disappeared completely. After 2 weeks the cavogram in these patients showed no signs of thrombosis, and 12 (71%) of the patients remained symptom-free. There was partial occlusion in 5 patients (29%), without relevant clinical symptoms. Of the 13 patients who received Wallstents, only 1 had an acute immediate thrombosis (8%). Symptoms disappeared completely in the other 12 patients and no signs of thrombosis were seen. However, after 2 weeks complete stent occlusion with SVCS was found in 3 patients (23%) and partial occlusion with minor clinical symptoms in 6 (46%). Only 3 patients (23%) had complete relief of their SVCS. The difference between the rates of occlusion of the two stents after 2 weeks was highly significant (p= 0.008). Conclusions: The overall clinical success rate for long-term patency was 100% for the Z-stents and 69% for the new Wallstent. These results suggest that when used for this purpose, the new Wallstent is more thrombogenic at 2 weeks than the Z-stent.

  6. Intimal hyperplasia following implantation of helical-centreline and straight-centreline stents in common carotid arteries in healthy pigs: influence of intraluminal flow†

    PubMed Central

    Caro, Colin Gerald; Seneviratne, Anusha; Heraty, Kevin B.; Monaco, Claudia; Burke, Martin G.; Krams, Rob; Chang, Carlos C.; Coppola, Gianfilippo; Gilson, Paul

    2013-01-01

    Intimal hyperplasia (IH) is a leading cause of obstruction of vascular interventions, including arterial stents, bypass grafts and arteriovenous grafts and fistulae. Proposals to account for arterial stent-associated IH include wall damage, low wall shear stress (WSS), disturbed flow and, although not widely recognized, wall hypoxia. The common non-planarity of arterial geometry and flow, led us to develop a bare-metal, nitinol, self-expanding stent with three-dimensional helical-centreline geometry. This was deployed in one common carotid artery of healthy pigs, with a straight-centreline, but otherwise identical (conventional) stent deployed contralaterally. Both stent types deformed the arteries, but the helical-centreline device additionally deformed them helically and caused swirling of intraluminal flow. At sacrifice, one month post stent deployment, histology revealed significantly less IH in the helical-centreline than straight-centreline stented vessels. Medial cross-sectional area was not significantly different in helical-centreline than straight-centreline stented vessels. By contrast, luminal cross-sectional area was significantly larger in helical-centreline than straight-centreline stented vessels. Mechanisms considered to account for those results include enhanced intraluminal WSS and enhanced intraluminal blood–vessel wall mass transport, including of oxygen, in the helical-centreline stented vessels. Consistent with the latter proposal, adventitial microvessel density was lower in the helical-centreline stented than straight-centreline stented vessels. PMID:24132200

  7. Y-Shaped Bilateral Self-Expandable Metallic Stent Placement for Malignant Hilar Biliary Obstruction: Data from a Referral Center for Palliative Care

    PubMed Central

    Di Mitri, R.; Mocciaro, F.

    2014-01-01

    Background and Aim. Malignant hilar strictures are a clinical challenge because of the current therapeutic approach and the poor prognosis. In recent years, self-expandable metallic stents have proven more effective than plastic stents for palliation of malignant hilar strictures, with the bilateral stent-in-stent technique registering a high success rate. We report our experience with Y-shaped endoscopic self-expandable metallic stents placement for treatment of advanced malignant hilar strictures. Methods. From April 2009 to August 2012, we prospectively collected data on patients treated with Y-shaped SEMS placement for advanced malignant hilar carcinoma. Data on technical success, clinical success, and complications were collected. Results. Twenty patients (9 males) were treated (mean age 64.2 ± 15.3 years). The grade of malignant hilar strictures according to the Bismuth classification was II in 5 patients (25%), IIIa in 1 (5%), and IV in 14 (70%). The mean bilirubin level was 14.7 ± 4.9 mg/dL. Technical success was achieved in all patients, with a significant reduction in bilirubin levels (2.9 ± 1.7 mg/dL). One patient experienced cholangitis as early complication, while in 2 patients stent ingrowth was observed. No stents migration was recorded. There was no procedure-related mortality. At the end of the follow-up (7.1 ± 3.1 months), 13 of the 20 patients (65%) had died. Conclusions. Our experience confirms endoscopic bilateral self-expandable metallic stents placement with stent-in-stent technique (Y-shaped configuration) as a feasible, effective, and safe procedure for palliation of unresectable malignant hilar strictures. PMID:24790548

  8. Carotid stenting using tapered and nontapered stents: associated neurological complications and restenosis rates.

    PubMed

    Brown, Katherine E; Usman, Asad; Kibbe, Melina R; Morasch, Mark D; Matsumura, Jon S; Pearce, William H; Amaranto, Daniel J; Eskandari, Mark K

    2009-01-01

    Self-expanding stent design systems for carotid artery stenting (CAS) have morphed from nontapered (NTS) to tapered (TS); however, the impact of this change is unknown. We reviewed the outcomes of CAS with these two broad categories of stents in a single-center retrospective review of 308 CAS procedures from May 2001 to July 2007. Nitinol self-expanding TS or NTS coupled with cerebral embolic protection devices were used to treat extracranial carotid occlusive disease. Data analysis included demographics, procedural records, duplex exams, and conventional arteriography. Mean follow-up was 18 months (range 1-69). Restenosis was defined as >or=80% in-stent carotid artery stenosis by angiography. The mean age of the entire cohort was 71.3 years (75% men, 25% women). Of the 308 cases, 233 were de novo lesions and 75 had a prior ipsilateral carotid endarterectomy (n = 44) or external beam radiation exposure (n = 31). Preprocedure neurological symptoms were present in 30% of patients. TS were used in 156 procedures and NTS in 152 procedures. The 30-day ipsilateral stroke and death rates were 1.3% and 0.3%, respectively. An additional three (1.0%) posterior circulation strokes occurred. There was no statistically significant difference in the 30-day total stroke rates between TS (3.2%, n = 5) and NTS (1.3%, n = 2) (p = 0.5). At midterm follow-up, restenosis or asymptomatic occlusion was detected in eight cases (2.6%). All occurred in arteries treated with NTS, and this was statistically different when compared to arteries treated with TS (p = 0.03). Furthermore, a post-hoc subgroup analysis revealed significant correlation (chi(2) = 0.02) for restenosis in "hostile necks" when separated by TS vs. NTS. Early CAS outcomes between TS and NTS are comparable. In contrast, self-expanding nitinol TS may have a lower incidence of significant restenosis or asymptomatic occlusion when compared to NTS.

  9. Lubrication of Nitinol 60

    NASA Technical Reports Server (NTRS)

    Pepper, Stephen V.; DellaCorte, Christopher; Glennon, Glenn

    2010-01-01

    The mechanical properties of Nitinol 60, 60 wt% Ni, 40 wt% Ti (55 at.% Ni, 45 at.% Ti) are sufficiently attractive to warrant its consideration as a lubricated triboelement. Triboelements are always run lubricated. The ability to lubricate Nitinol 60 by the oils usually used on spacecraft mechanisms--Pennzane 2001A, Krytox 143AC and Castrol 815Z--was experimentally determined. These oils were run in the boundary lubrication regime for Nitinol 60 balls running against Nitinol 60 counterfaces in the vacuum spiral orbit tribometer. Test results consisting of the coefficient of friction versus time (friction traces) and relative degradation rates of the oils are presented. Contrary to the inability to successfully lubricate other metal alloys with high titanium content, it was found that Nitinol 60 is able to be lubricated by these oils. Overall, the results presented here indicate that Nitinol 60 is a credible candidate material for bearing applications.

  10. Placement of a new fully covered self-expanding metal stent for postoperative biliary strictures and leaks not responding to plastic stenting.

    PubMed

    Luigiano, Carmelo; Bassi, Marco; Ferrara, Francesco; Fabbri, Carlo; Ghersi, Stefania; Morace, Carmela; Consolo, Pierluigi; Maimone, Antonella; Galluccio, Gabriella; D'Imperio, Nicola; Cennamo, Vincenzo

    2013-04-01

    Fully covered self-expanding metal stents (FCSEMSs) are now being used to treat postoperative biliary strictures (BSs) and biliary leaks (BLs). The aim of this study was to assess the safety and effectiveness of a new FCSEMS (Wallflex) in patients with postoperative BSs and BLs after failure of traditional endoscopic treatment. Between January 2010 and December 2011, 16 patients (10 patients with postcholecystectomy BSs, 4 with postcholecystectomy BLs, and 2 with postorthotopic liver transplantation BSs) were enrolled. The technical and clinical success rate was 100%. All FCSEMSs were removed after a mean of 141 days. Complications occurred in 7 cases: 2 postprocedure pain, 2 mild pancreatitis, 1 early distal, and 2 late proximal FCSEMS migration. The overall long-term clinical success rate was 94% after a mean follow-up of 13 months. In our experience, the placement of FCSEMSs is an effective and secure method of treating refractory postoperative BSs or BLs.

  11. In-Graft Endovascular Stenting Repair for Supravalvular Stenosis From Aortic Rupture After Balloon-Expanding Transcatheter Aortic Valve Implantation.

    PubMed

    Furukawa, Nobuyuki; Scholtz, Werner; Haas, Nikolaus; Ensminger, Stephan; Gummert, Jan; Börgermann, Jochen

    2015-01-01

    An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.

  12. Nitinol Temperature Monitoring Devices

    DTIC Science & Technology

    1976-01-09

    AD-A021 578 NITINOL TEMPERATURE MONITORING DEVICES William J. Buehler, et al Naval Surface Weapons Center Silver Spring, Maryland 9 January 1976...LABORATORY S NITINOL TEMPERATURE MONITORING DEVICES 9 JANUARY 1976 NAVAL SURFACE WEAPONS CENTER WHITE OAK LABORATORY SILVER SPRING, MARYLAND 20910 * Approved...GOVT ACCESSION NO. 3. RECIPIIENT’S CATALOG NUMBER NSWC/WOL/TR 75-140 ____ ______ 4 TITLE (and Subtitle) 5. TYPE OF REPCRT & PERIOD COVERED Nitinol

  13. In Vitro Hemocompatibility of Thin Film Nitinol In Stenotic Flow Conditions

    PubMed Central

    Kealey, C.P.; Whelan, S.A.; Chun, Y.J.; Soojung, C.H.; Tulloch, A.W.; Mohanchandra, K.P.; DiCarlo, D; Levi, D.S.; Carman, G.P.; Rigberg, D.A.

    2010-01-01

    Because of its low profile and biologically inert behavior, thin film nitinol (TFN) is ideally suited for use in construction of endovascular devices. We have developed a surface treatment for TFN designed to minimize platelet adhesion by creating a super-hydrophilic surface. The hemocompatibility of expanded polytetrafluorethylene (ePTFE), untreated thin film nitinol (UTFN), and a surface treated superhydrophilic thin film nitinol (STFN) was compared using an in vitro circulation model with whole blood under flow conditions simulating a moderate arterial stenosis. Scanning electron microscopy analysis showed increased thrombus on ePTFE as compared to UTFN or STFN. Total blood product deposition was 6.3 ± 0.8 mg/cm2 for ePTFE, 4.5 ± 2.3 mg/cm2 for UTFN, and 2.9 ± 0.4 mg/cm2 for STFN (n = 12, p < 0.01). ELISA assay for fibrin showed 326 ± 42 µg/cm2 for ePTFE, 45.6 ± 7.4 µg/cm2 for UTFN, and 194 ± 25 µg/cm2 for STFN (n = 12, p < 0.01). Platelet deposition measured by fluorescent intensity was 79,000 ± 20000 AU/mm2 for ePTFE, 810 ± 190 AU/mm2 for UTFN, and 1600 ± 25 AU/mm2 for STFN (n = 10, p < 0.01). Mass spectrometry demonstrated a larger number of proteins on ePTFE as compared to either thin film. UTFN and STFN appear to attract significantly less thrombus than ePTFE. Given TFN's low profile and our previously demonstrated ability to place TFN covered stents in vivo, it is an excellent candidate for use in next-generation endovascular stents grafts. PMID:20810163

  14. The intrinsically high pitting corrosion resistance of mechanically polished nitinol in simulated physiological solutions.

    PubMed

    Bai, Zhijun; Rotermund, Harm H

    2011-10-01

    Nitinol wires have been widely used in many biomedical applications, such as cardiovascular stent due to their superelasticity and shape memory effect. However, their corrosion properties and the related biocompatibility are not well understood, and the reported results are controversial. In this study, we evaluate the pitting corrosion property of nitinol, titanium, nickel, and 316L stainless steel (316LSS) wires with different surface roughnesses in a saline solution at 37 °C. The cyclic potentiodynamic polarization results show that mechanically polished nitinol and Ti wires are highly resistant to pitting corrosion, while Ni and 316LSS wires are susceptible to pitting corrosion. Electrochemical impedance spectroscopy is used to study the interface of oxide film/solution and all mechanically polished nitinol wires are covered by 2-3 nm thick films formed under open circuit potential. Furthermore, the electronic structures and semiconducting properties of passive films on nitinol, Ti and Ni wires are studied by Mott-Schottky analysis. Passive films formed on nitinol and Ti exhibit n-type semiconducting characteristics, whereas films on Ni show p-type semiconducting characteristics. Scanning Kelvin Microscopy is used to measure the surface potential difference between common inclusions from the nitinol matrix and the results indicate that the inclusions are more electrochemically noble than the nitinol matrix. Band energy theory is used to model the electrochemical interface between the passive films of nitinol and the solution under different applied potential conditions. A mechanism for the strong pitting corrosion resistance of nitinol in saline solution is proposed.

  15. Carotid artery stenting: which stent for which lesion?

    PubMed

    Bosiers, Marc; Deloose, Koen; Verbist, Jürgen; Peeters, Patrick

    2005-01-01

    The different geometries and working principles of carotid stents (nitinol or cobalt chromium, open- or closed-cell configuration) provide each product with unique functional properties. The individual characteristics of each device may make it an attractive choice in one circumstance but render it less desirable in other situations. In approximately 75% of all procedures, all types of stents will achieve similar outcomes, making adequate device selection unnecessary. For the remaining quarter, careful preoperative screening is mandatory. In addition to eventual access issues, the choice of the optimal carotid stent depends mainly on arterial anatomy and lesion morphology. When treating a tortuous anatomy, stents with a flexible and comformable open-cell configuration are preferred. In arteries with a significant mismatch between common carotid artery and internal carotid artery diameter, cobalt chromium (Elgiloy) or tapered nitinol stents are selected. Lesions with suspected high emboligenicity are best covered with stents with a closed-cell configuration, whereas highly calcified lesions need treatment with nitinol stents. Thorough knowledge of the characteristics, advantages and disadvantages, and working principles of the different available stents is mandatory to optimally select the materials to be used for patients eligible for carotid revascularization.

  16. Role of Stent Grafts and Helical-Woven Bare-Metal Stents in the Superficial Femoral and Popliteal Arteries.

    PubMed

    Madassery, Sreekumar; Turba, Ulku C; Arslan, Bulent

    2016-06-01

    Peripheral vascular disease (PVD) is a devastating medical problem that may lead to significant life alterations for patients, from simply limiting their daily activities to potential loss of limbs and eventual demise. Superficial femoral and popliteal arteries are significantly common locations for PVD sequelae to present itself, and owing to their length and mobile nature, treatment of these segments are quite challenging. Indications for PVD treatment include lifestyle-limiting claudication that is not responding to medical management, ischemic rest pain, nonhealing ulcers, and lower extremity gangrene. There is a wide variety of treatment options that include medical management, interventional, and surgical techniques. Interventional techniques include plain old balloon angioplasty, cryoplasty, drug-coated balloon angioplasty, self-expanding bare-nitinol stents, self-expanding covered stents, self-expanding drug-eluding stents, and a number of atherectomy devices (ie, laser, rotational, orbital, and excisional). The scope of this article is to review indications, patient selection, and deployment techniques of Viabahn and Supera self-expanding stents.

  17. Antireflux versus conventional self-expanding metallic Stents (SEMS) for distal esophageal cancer: results of a multicenter randomized trial

    PubMed Central

    Coron, E.; David, G.; Lecleire, S.; Jacques, J.; Le Sidaner, A.; Barrioz, T.; Coumaros, D.; Volteau, C.; Vedrenne, B.; Bichard, P.; Boustière, C.; Touchefeu, Y.; Brégeon, J.; Prat, F.; Le Rhun, M.

    2016-01-01

    Introduction: Self-expanding metal stents (SEMS) are commonly used in the palliation of dysphagia in patients with inoperable esophageal carcinoma. However, they predispose to gastroesophageal reflux when deployed across the gastroesophageal junction. The aims of this study were to: 1) assess the influence of the antireflux valve on trans-prosthetic reflux (primary outcome); and 2) compare the results of SEMS with and without antireflux valve in terms of reflux symptoms, quality of life (QOL), improvement of dysphagia and adverse events (secondary outcomes). Patients and methods: Thirty-eight patients were enrolled in nine centers. Carcinomas were locally advanced (47 %) or metastatic. After randomization, patients received either a covered SEMS with antireflux valve (n = 20) or a similar type of SEMS with no antireflux device but assigned to standard proton pump inhibitor therapy and postural advice (n = 18). Trans-prosthetic reflux was assessed at day 2 using a radiological score based on barium esophagography performed after Trendelenburg maneuver and graded from 0 (no reflux) to 12 (maximum). Monthly telephone interviews were conducted for Organisation Mondiale de la Santé (OMS) scoring from 0 (excellent) to 5 (poor), QOL assessment (based on the Reflux-Qual Simplifié scoring system) from 0 (poor) to 100 (excellent), dysphagia scoring from 0 (no dysphagia) to 5 (complete dysphagia) and regurgitation scoring from 0 (no regurgitation) to 16 (maximum). Results: No difference was noted in terms of age, sex, size of lesion, prosthesis length or need for dilation prior to SEMS placement. No difficulty in placing SEMS nor complications were noted. Radiological scores of reflux were found to be significantly lower in patients with an antireflux stent compared to the conventional stent and associated measures. The regurgitation scores were significantly decreased in patients with antireflux stents during the first 2 months after stent placement and

  18. Salvage therapy using self-expandable metal stents for recalcitrant anastomotic strictures after living-donor liver transplantation

    PubMed Central

    Jang, Sung Ill; Sung, Se Yong; Park, Hyunsung; Lee, Kwang-Hun; Joo, Seung-Moon; Lee, Dong Ki

    2017-01-01

    Background: Recently, there has been an increase in clinical success rates using nonsurgical methods to resolve anastomotic biliary strictures (ABSs) that develop after liver transplantation (LT). However, some strictures are particularly refractory and cannot be completely resolved by an endoscopic or percutaneous procedure. Consequently, the aim of this study was to examine the feasibility and efficacy of using a newly designed fully covered self-expandable metal stent (FCSEMS) to resolve refractory ABS. Methods: A total of 35 patients with an ABS that developed after LT, but could not be resolved by an endoscopic or percutaneous procedure, were included in this study. FCSEMSs were positioned endoscopically and removed after 2–3 months. After stent removal, the patients were followed to assess complications, including re-stenosis. Results: The mean period from LT to stricture was 13.7 months, and the mean duration of the stricture was 31.8 months. The type and mean number of procedures previously attempted were endoscopic retrograde cholangiopancreatography (ERCP) (9.1 ± 5.1) in 19 patients and percutaneous transhepatic biliary drainage (9.2 ± 4.8) in 16 patients. All patients had successful FCSEMS insertions and removals; the mean stent indwelling time was 3.2 months. The mean follow-up period was 18.7 months (range: 6.4–37.8 months). Stricture recurrence was observed in 6 of 29 patients (recurrence rate: 20.7%). The anastomotic stricture resolved with the FCSEMS insertion in 29 of 35 patients (clinical success rate: 82.9%). Conclusions: The newly designed FCSEMS is a potentially feasible and effective treatment for anastomotic strictures that develop after LT but are not amenable to treatment by conventional procedures. PMID:28246547

  19. Self-expanding metal stents for the palliation of malignant gastric outlet obstruction in patients with peritoneal carcinomatosis

    PubMed Central

    Rademacher, Christoph; Bechtler, Matthias; Schneider, Steffen; Hartmann, Bettina; Striegel, Johannes; Jakobs, Ralf

    2016-01-01

    AIM To evaluate the efficacy of self-expanding metal stents (SEMS) for the palliation of malignant gastric outlet obstruction in patients with and without peritoneal carcinomatosis (PC). METHODS We performed a retrospective analysis of 62 patients who underwent SEMS placement for treatment of malignant gastroduodenal obstruction at our hospital over a six-year period. Stents were deployed through the scope under combined fluoroscopic and endoscopic guidance. Technical success was defined as successful stent placement and expansion. Clinical success was defined as an improvement in the obstructive symptoms and discharge from hospital without additional parenteral nutrition. According to carcinomatosis status, patients were assigned into groups with or without evidence of peritoneal disease. RESULTS In most cases, obstruction was caused by pancreatic (47%) or gastric cancer (23%). Technical success was achieved in 96.8% (60/62), clinical success in 79% (49/62) of all patients. Signs of carcinomatosis were identified in 27 patients (43.5%). The diagnosis was confirmed by pathology or previous operation in 7 patients (11.2%) and suspected by CT, MRI or ultrasound in 20 patients (32.2%). Presence of carcinomatosis was associated with a significantly lower clinical success rate compared to patients with no evidence of peritoneal disease (66.7% vs 88.6%, P = 0.036). There was no significant difference in overall survival between patients with or without PC (median 48 d vs 70 d, P = 0.21), but patients showed significantly longer survival after clinical success of SEMS placement compared to those experiencing clinical failure (median 14.5 d vs 75 d, P = 0.0003). CONCLUSION Given the limited therapeutic options and a clinical success rate of at least 66.7%, we believe that SEMS are a reasonable treatment option in patients with malignant gastric outlet obstruction with peritoneal carcinomatosis. PMID:27920476

  20. Reocclusion after Self-Expandable Metallic Stent Placement for Relieving Malignant Colorectal Obstruction as a Palliative Treatment

    PubMed Central

    Nitta, Toshikatsu; Fujii, Kensuke; Hirata, Yoshimasa; Tominaga, Tomo; Inoue, Yoshihiro; Kawasaki, Hiroshi; Kawakami, Ken; Ishibashi, Takashi

    2016-01-01

    Self-expandable metallic stent (SEMS) placement has been practiced in several hospitals in Japan, including ours, since January 2012. Here, we report the case of an 82-year-old Japanese man who presented to the hospital with a 1-week history of right hypochondrial pain. Computed tomography (CT) findings indicated colorectal cancer. The laboratory findings on admission indicated severe anemia (red blood cell count, 426 × 104/μL; hemoglobin, 7.9 g/dL). We performed SEMS placement because the patient refused to undergo surgery. He did not attend any of the scheduled follow-up visits after SEMS placement. However, a year and a half after the SEMS placement, the patient attended the hospital because of difficulty in passing stool. A plain abdominal CT scan showed bowel reobstruction due to the ascending colon cancer after SEMS placement. We performed an emergency operation, ascending colostomy, on the same day. Colorectal stent placement may be a good treatment option for patients who refuse to undergo conventional therapeutic treatments or in those with unresectable colorectal cancer. Patients should be carefully followed up every few months after SEMS placement because of the risk of reocclusion. PMID:28100994

  1. Targeting In-Stent-Stenosis with RGD- and CXCL1-Coated Mini-Stents in Mice

    PubMed Central

    Weinandy, Stefan; Schreiber, Fabian; Megens, Remco T. A.; Theelen, Wendy; Smeets, Ralf; Jockenhövel, Stefan; Gries, Thomas; Möller, Martin; Klee, Doris; Weber, Christian; Zernecke, Alma

    2016-01-01

    Atherosclerotic lesions that critically narrow the artery can necessitate an angioplasty and stent implantation. Long-term therapeutic effects, however, are limited by excessive arterial remodeling. We here employed a miniaturized nitinol-stent coated with star-shaped polyethylenglycole (star-PEG), and evaluated its bio-functionalization with RGD and CXCL1 for improving in-stent stenosis after implantation into carotid arteries of mice. Nitinol foils or stents (bare metal) were coated with star-PEG, and bio-functionalized with RGD, or RGD/CXCL1. Cell adhesion to star-PEG-coated nitinol foils was unaltered or reduced, whereas bio-functionalization with RGD but foremost RGD/CXCL1 increased adhesion of early angiogenic outgrowth cells (EOCs) and endothelial cells but not smooth muscle cells when compared with bare metal foils. Stimulation of cells with RGD/CXCL1 furthermore increased the proliferation of EOCs. In vivo, bio-functionalization with RGD/CXCL1 significantly reduced neointima formation and thrombus formation, and increased re-endothelialization in apoE-/- carotid arteries compared with bare-metal nitinol stents, star-PEG-coated stents, and stents bio-functionalized with RGD only. Bio-functionalization of star-PEG-coated nitinol-stents with RGD/CXCL1 reduced in-stent neointima formation. By supporting the adhesion and proliferation of endothelial progenitor cells, RGD/CXCL1 coating of stents may help to accelerate endothelial repair after stent implantation, and thus may harbor the potential to limit the complication of in-stent restenosis in clinical approaches. PMID:27192172

  2. TIPS for refractory ascites: a 6-year single-center experience with expanded polytetrafluoroethylene-covered stent-grafts.

    PubMed

    Bercu, Zachary L; Fischman, Aaron M; Kim, Edward; Nowakowski, F Scott; Patel, Rahul S; Schiano, Thomas D; Chang, Charissa Y; Lookstein, Robert A

    2015-03-01

    OBJECTIVE. This single-center study evaluated the use of expanded polytetrafluoroethylene (ePTFE)-covered stent-grafts for transjugular intrahepatic portosystemic shunt (TIPS) placement to manage portal hypertension-related refractory ascites. MATERIALS AND METHODS. One hundred patients at a single tertiary care center in a major metropolitan hospital underwent TIPS placement with an ePTFE-covered stent-graft (Viatorr TIPS Endoprosthesis). Patients with portal hypertension-related ascites and preexisting hepatocellular carcinoma or liver transplant were excluded from the analysis. Records were reviewed for demographic characteristics, technical success of the TIPS procedures, and stent follow-up findings. Clinical results were assessed at 90- and 180-day intervals. RESULTS. Immediate technical success of the TIPS procedure was 100%. Of the 61 patients with documented follow-up, 55 (90.2%) had a partial or complete ascites response to TIPS creation. Of these 55 patients, nine experienced severe encephalopathy. Six of 61 patients (9.8%) did not experience a significant ascites response. Overall survival was 78.7% at 365-day follow-up. The 365-day survival was 84.2% for patients with a model for end-stage liver disease (MELD) score of less than 15, 67.0% for those with a score of 15-18, and 53.8% for those with a score of greater than 18 (p = 0.01). For patients with a MELD score of less than 18, the 365-day survival was 88.0% for those with an albumin value of 3 mg/dL or greater and 72.8% for those with an albumin value of less than 3 mg/dL (p = 0.04). CONCLUSION. TIPS placement using an ePTFE-covered stent-graft is an efficacious therapy for refractory ascites. Patients with preserved liver function-characterized by a MELD score of less than 15 or a MELD score of less than 18 and an albumin value of 3 mg/dL or greater-experience the greatest survival benefit.

  3. Early Stent Graft Perforation after Endovascular Repair for Pseudoaneurysm That Was Associated with Clavicle Nonunion

    PubMed Central

    Touma, Masanao; Ohno, Nobuhisa; Yoshikawa, Eiji; Yoshizawa, Kousuke; Fujiwara, Keiichi

    2015-01-01

    We report the case of a 62-year-old man who experienced a left axillary artery pseudoaneurysm that was secondary to nonunion of a 30-year-old left midshaft clavicle fracture. He initially underwent endovascular repair using a self-expanding nitinol stent graft, which was perforated at postoperative day 5. Therefore, we performed open repair with concomitant clavicle resection, and no complications were observed during an approximately 6-year follow-up. We recommend performing clavicle resection with vascular repair to prevent recurrence in similar cases. PMID:26421082

  4. Correction: Prospective pilot study of fully covered self-expandable metal stents for refractory benign pancreatic duct strictures: long-term outcomes

    PubMed Central

    Matsubara, Saburo; Sasahira, Naoki; Isayama, Hiroyuki; Takahara, Naminatsu; Mizuno, Suguru; Kogure, Hirofumi; Yamamoto, Natsuyo; Nakai, Yousuke; Tada, Minoru; Koike, Kazuhiko

    2016-01-01

    Background and study aims: Background and study aims: Temporary placement of a fully covered self-expandable metal stent (FCSEMS) has recently emerged as a treatment option for pancreatic duct strictures due to chronic pancreatitis refractory to conventional plastic stenting. However, there are no data about long-term outcomes with this therapeutic option. The aims of the current study were to estimate the feasibility, safety, efficacy, and long-term outcomes of temporary FCSEMS placement for refractory pancreatic duct strictures. Patients and methods: This was a prospective, single-center feasibility study. Ten patients with refractory pancreatic duct strictures due to chronic pancreatitis underwent FCSEMS placement for 3 months. We evaluated the rate of recurrent symptoms after stent removal during long-term follow-up, as well as adverse events (AEs). Results: Two patients required early (within 1 week) stent removal because of intolerable pain or pancreatitis. In the remaining 8 patients, the recurrence rate of any symptoms after FCSEMS removal was 63% during 35 months of follow up. The causes of recurrent symptoms were as follows: recurrence of stricture in 2; stent-induced stricture in 1; impaction of pancreatic stones in 1; and development of a pseudocyst in 1. When limited to stricture, the recurrence rate was 38%. Additional endoscopic treatments were required in 4 patients: a second FCSEMS placement in 1; plastic stent (PS) placement in 1; stone extraction in 1; and endoscopic ultrasound–guided pseudocyst drainage in 1. Asymptomatic stent migration occurred in 2 patients. Suppurative pancreatic ductitis due to food impaction in the FCSEMS occurred in 2 patients, and endoscopic pancreatic duct drainage was performed. Stent-induced ductal changes developed in 2 patients and PS treatment was required in 1 patient for pain relief. Conclusion: The FCSEMS appears to be a feasible and potentially effective option for the management of refractory pancreatic duct

  5. Feasibility, safety, and preliminary efficacy of a novel ePTFE-covered self-expanding stent in saphenous vein graft lesions: the Symbiot II trial.

    PubMed

    Laarman, Gerrit J; Kiemeneij, Ferdinand; Mueller, Ralf; Guagliumi, Giuglio; Cobaugh, Michael; Serruys, Patrick W

    2005-03-01

    Compared with percutaneous interventions in native coronary arteries, revascularization of saphenous vein graft (SVG) lesions is associated with increased rates of immediate and long-term major adverse cardiac events (MACE). The Symbiot II trial was a multicenter prospective study designed to evaluate the feasibility and safety of a novel self-expanding polytetrafluoroethylene (ePTFE)-covered stent in the treatment of de novo and restenotic SVG lesions. The primary endpoint was MACE through 30 days postprocedure. Successful Symbiot stent deployment was achieved in 75 of 77 patients (97.4%) with SVG lesions < or = 35 mm in length (visual assessment). The procedural success rate (defined as < 30% residual stenosis at the target site and no clinical complications) was 83%, and all study device procedures provided grade 3 TIMI flow postprocedure. Within the first 30 days postprocedure, four patients (5.2%) experienced MACE (defined as death, Q-wave or non-Q-wave myocardial infarction, and clinically driven target vessel revascularization), of whom three patients (3.9%) experienced periprocedural non-Q-wave myocardial infarction. No subacute stent thrombosis was observed over the 6-month follow-up period. No relevant luminal loss at the target site (mean, 0.3 +/- 0.9 mm) was observed in the 58 patients (77.3% of enrolled patients) who underwent quantitative coronary angiography at 6 months. The incidences of binary in-stent restenosis, in-segment restenosis, and target vessel failure (defined as acute and late-term MACE through 6 months postprocedure) were low (7.0%, 8.6%, and 14.3%, respectively). The Symbiot self-expanding ePTFE membrane-covered stent was associated with a high procedural success rate (97.4%), low incidences of MACE at 30 days (5.2%) and 6 months (14.3%), suggesting that it is safe and effective in the treatment of SVG disease.

  6. Nitinol-based nanotubular coatings for the modulation of human vascular cell function.

    PubMed

    Lee, Phin P; Cerchiari, Alec; Desai, Tejal A

    2014-09-10

    In this study, we describe the synthesis of an upright nanotubular coating with discrete, exposed nanotubes on top of superelastic Nitinol via anodization and characterization of the surface elemental composition and nickel release rates. We demonstrate, for the first time, that this coating could improve re-endothelialization by increasing the cell spreading and migration of primary human aortic endothelial cells on Nitinol. We also show the potential for reducing neointimal hyperplasia by decreasing the proliferation and expression of collagen I and MMP-2 in primary human aortic smooth muscle cells (HASMC). Furthermore, we did not observe the nanotubular surface to induce inflammation through ICAM-1 expression in HASMC as compared to the flat control. This coating could be used to improve Nitinol stents by reducing restenosis rates and, given the extensive use of Nitinol in other implantable devices, act as a generalized coating strategy for other medical devices.

  7. Self-Expandable Stent Placement in Infrapopliteal Arteries After Unsuccessful Angioplasty Failure: One-Year Follow-up

    SciTech Connect

    Peregrin, J. H. Smirova, S.; Koznar, B.; Novotny, J.; Kovac, J.; Lastovickova, J.; Skibova, J.

    2008-09-15

    The purpose of this prospective study was to evaluate whether stent placement in infrapopliteal arteries is helpful in failed percutaneous transluminal angioplasty (PTA). Infrapopliteal PTA was performed in 70 arteries of 66 patients with chronic critical lower limb ischemia. The group comprised 55 males and 11 females, with an average age of 63.4 (range, 42-82) years. Diabetes mellitus was present in 92.4% of patients. Only the palpable anterior tibial and posterior tibial arteries were evaluated. Stents (Xpert stent; Abbot Vascular, Redwood City, CA, USA) were placed in 16 arteries where PTA was not successful (the failure was defined as residual stenosis >30% after PTA). In 54 arteries simple PTA was performed and was technically successful. Twenty-four nondilated arteries with no significant stenosis served as a comparison group. The 12-month patency rate was evaluated according to a combination of palpation and Doppler ultrasound. In all cases stent placement restored the flow in the artery immediately after unsuccessful PTA. Twelve-month follow-up showed a patency rate of 82% in the PTA group, 78% in the stent group, and 69% in the comparison group. We conclude that stent placement in the case of unsuccessful infrapopliteal PTA changed technical failure to success and restored flow in the dilated artery. At 12-month follow-up the patency rate of infrapopliteal arteries stented for PTA failure did not differ significantly either from nonstented arteries with an optimal PTA result or from a comparison group of nonintervened arteries.

  8. A Material Model for the Cyclic Behavior of Nitinol

    NASA Astrophysics Data System (ADS)

    Rebelo, Nuno; Zipse, Achim; Schlun, Martin; Dreher, Gael

    2011-07-01

    The uniaxial behavior of Nitinol in different forms and at different temperatures has been well documented in the literature. Mathematical models for the three-dimensional behavior of this class of materials, covering superelasticity, plasticity, and shape memory effects have been previously developed. Phenomenological models embedded in FEA analysis are part of common practice today in the development of devices made out of Nitinol. In vivo loading of medical devices has cyclic characteristics. There have been some indications in the literature that cyclic loading of Nitinol modifies substantially its behavior. A consortium of several stent manufacturers, Safe Technology and Dassault Systèmes Simulia Corp., dedicated to the development of fatigue laws suitable for life prediction of Nitinol devices, has conducted an extensive experimental study of the modifications in uniaxial behavior of both Nitinol wire and tubing due to cyclic loading. The Abaqus Nitinol material model has been extended to capture some of the phenomena observed and is described in this article. Namely, a preload beyond 6% strain alters the transformation plateaus; if the cyclic load amplitude is large enough, permanent deformations (residual martensite) are observed; the lower plateau increases; and the upper plateau changes. The modifications to the upper plateau are very interesting in the sense that it appears broken: its start stress gets lowered creating a new plateau up to the highest level of cyclic strain, followed by resuming the original plateau until full transformation. Since quite often the geometry of a device at the point at which it is subjected to cyclic loading is very much dependent on the manufacturing, deployment, and preloading sequence, it is important that analyses be conducted with the original material behavior up to that point, and then with the cyclic behavior thereafter.

  9. Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction

    PubMed Central

    Nam, Hyeong Seok; Kang, Dae Hwan; Kim, Hyung Wook; Choi, Cheol Woong; Park, Su Bum; Kim, Su Jin; Ryu, Dae Gon

    2017-01-01

    AIM To evaluate the safety and efficacy of limited endoscopic sphincterotomy (ES) before placement of self-expandable metal stent (SEMS). METHODS This was a retrospective analysis of 244 consecutive patients with unresectable malignant biliary obstruction, who underwent placement of SEMSs following limited ES from December 2008 to February 2015. The diagnosis of malignant biliary obstruction and assessment of patient eligibility for the study was established by a combination of clinical findings, laboratory investigations, imaging and pathological results. All patients were monitored in the hospital for at least 24 h following endoscopic retrograde cholangio pancreatography (ERCP). The incidence of immediate or early post-ERCP complications such as post-ERCP pancreatitis (PEP) and bleeding related to limited ES were considered as primary outcomes. Also, characteristics and complications according to the cancer type were classified. RESULTS Among the 244 patients included, the underlying diagnosis was cholangiocarcinoma in 118 patients, pancreatic cancer in 79, and non-pancreatic or non-biliary malignancies in the remaining 47 patients. Early post-ERCP complications occurred in 9 patients (3.7%), with PEP in 7 patients (2.9%; mild, 6; moderate, 1) and mild bleeding in 2 patients (0.8%). There was no significant association between the incidence of post-ERCP complications and the type of malignancy (cholangiocarcinoma vs pancreatic cancer vs others, P = 0.696) or the type of SEMS used (uncovered vs covered, P = 1.000). Patients who had more than one SEMS placed at the first instance were at a significantly higher risk of post-ERCP complications (one SEMS vs two SEMS, P = 0.031). No other factors were predictive of post-ERCP complications. CONCLUSION Limited ES is feasible and safe, and effectively facilitates the placement of SEMS, without any significant risk of PEP or severe bleeding. PMID:28321164

  10. Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis: Long-term outcomes after removal of a self-expandable metal stent

    PubMed Central

    Kamata, Ken; Takenaka, Mamoru; Kitano, Masayuki; Omoto, Shunsuke; Miyata, Takeshi; Minaga, Kosuke; Yamao, Kentaro; Imai, Hajime; Sakurai, Toshiharu; Watanabe, Tomohiro; Nishida, Naoshi; Kudo, Masatoshi

    2017-01-01

    AIM To assess the long-term outcomes of this procedure after removal of self-expandable metal stent (SEMS). The efficacy and safety of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with SEMS were also assessed. METHODS Between January 2010 and April 2015, 12 patients with acute calculous cholecystitis, who were deemed unsuitable for cholecystectomy, underwent EUS-GBD with a SEMS. EUS-GBD was performed under the guidance of EUS and fluoroscopy, by puncturing the gallbladder with a needle, inserting a guidewire, dilating the puncture hole, and placing a SEMS. The SEMS was removed and/or replaced with a 7-Fr plastic pigtail stent after cholecystitis improved. The technical and clinical success rates, adverse event rate, and recurrence rate were all measured. RESULTS The rates of technical success, clinical success, and adverse events were 100%, 100%, and 0%, respectively. After cholecystitis improved, the SEMS was removed without replacement in eight patients, whereas it was replaced with a 7-Fr pigtail stent in four patients. Recurrence was seen in one patient (8.3%) who did not receive a replacement pigtail stent. The median follow-up period after EUS-GBD was 304 d (78-1492). CONCLUSION EUS-GBD with a SEMS is a possible alternative treatment for acute cholecystitis. Long-term outcomes after removal of the SEMS were excellent. Removal of the SEMS at 4-wk after SEMS placement and improvement of symptoms might avoid migration of the stent and recurrence of cholecystitis due to food impaction. PMID:28216973

  11. Stent-assisted detachable coil embolization of wide-necked renal artery aneurysms

    PubMed Central

    Bracale, Umberto Marcello; Narese, Donatella; Ficarelli, Ilaria; De Laurentis, Mario; Spalla, Flavia; Dinoto, Ettore; Vitale, Gaetano; Solari, Domenico; Bajardi, Guido; Pecoraro, Felice

    2017-01-01

    Renal artery aneurysms (RAAs) are rare with an estimated incidence of 0.1% in the general population, and they represent approximately 25% of all visceral aneurysms. The gold standard of treatment is open surgery, but it is associated with a high risk of nephrectomy, mortality, and morbidity. Less invasive endovascular therapies are becoming increasingly common for the treatment of RAAs. Here, we aimed to report three cases of wide-necked complex renal artery aneurysms treated endovascularly using stent-assisted coil embolization with self-expandable stent nitinol Solitaire AB and Concerto Axium coils. In addition, we describe the use of the waffle-cone technique in a case of wide-necked saccular RAA involving the renal artery bifurcation. Technical success was achieved in all three cases with no early or late complications and no recurrences. PMID:27854201

  12. Multidetector-Row Computed Tomography in the Evaluation of Transjugular Intrahepatic Portosystemic Shunt Performed with Expanded-Polytetrafluoroethylene-Covered Stent-Graft

    SciTech Connect

    Fanelli, Fabrizio Bezzi, Mario; Bruni, Antonio; Corona, Mario; Boatta, Emanuele; Lucatelli, Pierleone; Passariello, Roberto

    2011-02-15

    We assessed, in a prospective study, the efficacy of multidetector spiral computed tomography (MDCT) in the evaluation of transjugular intrahepatic portosystemic shunt (TIPS) patency in patients treated with the Viatorr (Gore, Flagstaff, AZ) expanded-polytetrafluoroethylene (e-PTFE)-covered stent-graft. Eighty patients who underwent TIPS procedure using the Viatorr self-expanding e-PTFE stent-graft were evaluated at follow-up of 1, 3, 6, and 12 months with clinical and laboratory tests as well as ultrasound-color Doppler (USCD) imaging. In case of varices, upper gastrointestinal endoscopy was also performed. In addition, the shunt was evaluated using MDCT at 6 and 12 months. In all cases of abnormal findings and discrepancy between MDCT and USCD, invasive control venography was performed. MDCT images were acquired before and after injection of intravenous contrast media on the axial plane and after three-dimensional reconstruction using different algorithms. MDCT was successfully performed in all patients. No artefacts correlated to the Viatorr stent-graft were observed. A missing correlation between UCSD and MDCT was noticed in 20 of 80 (25%) patients. Invasive control venography confirmed shunt patency in 16 (80%) cases and shunt malfunction in 4 (20%) cases. According to these data, MDCT sensitivity was 95.2%; specificity was 96.6%; and positive (PPV) and negative predictive values (NPV) were 90.9 and 98.2%, respectively. USCD sensitivity was 90%; specificity was 75%; and PPV and NPV were 54.5 and 95.7%, respectively. A high correlation (K value = 0.85) between MDCT and invasive control venography was observed. On the basis of these results, MDCT shows superior sensitivity and specificity compared with USCD in those patients in whom TIPS was performed with the Viatorr stent-graft. MDCT can be considered a valid tool in the follow-up of these patients.

  13. Coronary artery stent (image)

    MedlinePlus

    ... with a balloon catheter and expands when the balloon is inflated. The stent is then left there to help keep the artery open. ... with a balloon catheter and expands when the balloon is inflated. The stent is then left there to help keep the artery open.

  14. Endoscopic radiofrequency ablation combined with fully covered self-expandable metal stent for inoperable periampullary carcinoma in a liver transplant patient

    PubMed Central

    Tian, Qing; Wang, Guijie; Zhang, Yamin; Jin, Yan; Cui, Zilin; Sun, Xiaoye; Shen, Zhongyang

    2017-01-01

    Abstract Rationale: Postliver transplant periampullary carcinoma is an extremely uncommon disease. Patient concerns: Cutaneous jaundice in a patient who had received a liver transplant 4 years earlier. Diagnosis: Periampullary carcinoma. Interventions: Radiofrequency ablation plus fully covered self-expanding metal stents (FCSEMS). Outcomes: The treatment of malignant neoplasm of the ampulla of Vater is the patient by radiofrequency ablation plus FCSEMS placement was successful. No complications occurred. Lessons: This is the first reported case of a liver transplant patient with inoperable periampullary carcinoma successfully treated by radiofrequency ablation plus FCSEMS placement. Our experience will be useful to other surgeons in managing similar patients in the future. PMID:28151854

  15. Common Iliac Artery Thrombosis following Pelvic Surgery Resulting in Kidney Allograft Failure Successfully Treated by Percutaneous Transluminal Angioplasty with Balloon-Expandable Covered Stent

    PubMed Central

    Golla, Maheswara S.; Acharjee, Subasit; Jaber, Bertrand L.; Garcia, Lawrence A.

    2015-01-01

    We report the case of a 66-year-old woman who developed acute kidney allograft failure due to thrombotic occlusion of the common iliac artery after hysterectomy requiring emergent allograft rescue. She underwent percutaneous transluminal angioplasty with endovascular balloon expandable covered stent graft placement in the right common iliac artery. Although there are a handful of case reports of acute limb ischemia secondary to acute common iliac artery thrombosis, this is the first case reported in the literature resulting in successful kidney allograft rescue following pelvic surgery. PMID:26355669

  16. Endoscopic treatment of large pancreatic fluid collections (PFC) using self-expanding metallic stents (SEMS) – a two-center experience

    PubMed Central

    Chaves, Dalton Marques; Mönkemüller, Klaus; Carneiro, Fred; Medrado, Bruno; dos Santos, Marcos; Wodak, Stephanie; Reimão, Sílvia; Sakai, Paulo; de Moura, Eduardo

    2014-01-01

    Background/study aim: During the last several years, endoscopic ultrasound (EUS)-guided pancreatic fluid collections’ (PFC) drainage has evolved into the preferred drainage technique. Recently, self-expanding metallic stents (SEMS) have been used as an alternative to double pigtail stents, with the advantage of providing a larger diameter fistula, thereby decreasing the risk of early obstruction and also allowing for direct endoscopic exploration of the cavity. The aim of this study was to evaluate the technical and clinical success, safety, and outcome of patients undergoing EUS-guided drainage of complex PFC using SEMS. Patients/materials and methods: The study was conducted at two tertiary hospitals from January 2010 to January 2013. All patients with PFC referred for endoscopic drainage were enrolled in a prospective database. The inclusion criteria were: (1) patients with pseudocysts or walled-off necrosis based on the revised Atlanta classification; (2) symptomatic patients with thick PFC; (3) PFC that persisted more than 6 weeks; and (4) large PFC diameter (≥ 9 cm). The exclusion criteria consisted of coagulation disorders, PFC bleeding or infection, and failure-to-inform written consent. Results: A total of 16 patients (9 females, 7 males; mean age 52.6, range 20 – 82) underwent EUS drainage with SEMS. There were 14 cases of pseudocysts and 2 cases of walled-off necrosis. The etiologies of the PFC were mainly gallstones (8 of 16 patients, 50 %) and alcohol (5 of 16 patients, 31 %). Technical success was achieved in 100 % of the cases. All patients had a complete resolution of the PFC. Conclusion: Transmural EUS-guided drainage of complex PFC using SEMS is feasible, appears safe, and is efficacious. However, the exchange of the UC (uncovered)-SEMS for plastic stents is mandatory within 1 week. Future prospective studies, preferably multicenter studies, comparing SEMS versus traditional plastic stents for the drainage of PFC are

  17. Development of a New Hybrid Biodegradable Drug-Eluting Stent for the Treatment of Peripheral Artery Disease.

    PubMed

    Lee, Jung-Hee; Kim, Soon-Joong; Park, Se-Il; Ko, Young-Guk; Choi, Donghoon; Hong, Myeong-Ki; Jang, Yangsoo

    2016-01-01

    This study aimed to develop a new biodegradable stent for peripheral artery disease (PAD) that could provide sufficient radial force to maintain long-term patency and flexibility. All self-expandable hybrid biodegradable stents were designed by using a knitting structure composed of poly-L-lactic acid (PLLA) and nitinol. Four different types of stents were implanted in 20 iliac arteries in 10 mini pigs as follows: a bare-metal stent (BMS) (group 1, n = 5), a drug-free hybrid stent (group 2, n = 5), a 50% (50 : 100, w/w) paclitaxel (PTX)/poly-lactide-co-glycolic acid (PLGA; fast PTX-releasing form) hybrid stent (group 3, n = 5), and a 30% (30 : 100, w/w) PTX/PLGA (slow PTX-releasing form) hybrid stent (group 4, n = 5). We performed follow-up angiography and intravascular ultrasonography (IVUS) at 4 and 8 weeks. In a comparison of groups 1, 2, 3, and 4, less diameter stenosis was observed in the angiographic analysis for group 4 at the 4-week follow-up (19.0%  ±  12.7% versus 39.3%  ±  18.1% versus 46.8%  ±  38.0% versus 4.8%  ±  4.2%, resp.; p = 0.032). IVUS findings further suggested that the neointima of the patients in group 4 tended to be lesser than those of the others. Our new biodegradable 30% PTX/PLGA (slow-releasing form) stent showed more favorable results for patency than the other stent types.

  18. Development of a New Hybrid Biodegradable Drug-Eluting Stent for the Treatment of Peripheral Artery Disease

    PubMed Central

    Kim, Soon-Joong; Park, Se-Il; Jang, Yangsoo

    2016-01-01

    This study aimed to develop a new biodegradable stent for peripheral artery disease (PAD) that could provide sufficient radial force to maintain long-term patency and flexibility. All self-expandable hybrid biodegradable stents were designed by using a knitting structure composed of poly-L-lactic acid (PLLA) and nitinol. Four different types of stents were implanted in 20 iliac arteries in 10 mini pigs as follows: a bare-metal stent (BMS) (group 1, n = 5), a drug-free hybrid stent (group 2, n = 5), a 50% (50 : 100, w/w) paclitaxel (PTX)/poly-lactide-co-glycolic acid (PLGA; fast PTX-releasing form) hybrid stent (group 3, n = 5), and a 30% (30 : 100, w/w) PTX/PLGA (slow PTX-releasing form) hybrid stent (group 4, n = 5). We performed follow-up angiography and intravascular ultrasonography (IVUS) at 4 and 8 weeks. In a comparison of groups 1, 2, 3, and 4, less diameter stenosis was observed in the angiographic analysis for group 4 at the 4-week follow-up (19.0%  ±  12.7% versus 39.3%  ±  18.1% versus 46.8%  ±  38.0% versus 4.8%  ±  4.2%, resp.; p = 0.032). IVUS findings further suggested that the neointima of the patients in group 4 tended to be lesser than those of the others. Our new biodegradable 30% PTX/PLGA (slow-releasing form) stent showed more favorable results for patency than the other stent types. PMID:27999810

  19. Anatomy-shaped design of a fully-covered, biliary, self-expandable metal stent for treatment of benign distal biliary strictures

    PubMed Central

    Weigt, Jochen; Kandulski, Arne; Malfertheiner, Peter

    2016-01-01

    Background and study aims: The treatment success of benign biliary strictures with fully covered metal stents (CSEMS) is altered by high stent dislocation rates. We aimed to evaluate a new stent design to prevent dislocation. Patients and methods: Patients with benign biliary strictures were treated with a newly designed double-coned stent (dcSEMS). Mechanical analysis of the new stent was performed and it was compared with a cylindrical stent. Results: A total of 13 dcCSEMS were implanted in 11 patients (2 female, 9 male, median age 47, range 33 – 71). All patients had distal biliary strictures due to chronic pancreatitis. No stent migration occurred. In all but one patient the stents were removed. One patient refused stent extraction and was lost to follow up. Stent occlusion occurred twice leading to cholangitis in both cases. The duration of stent treatment was 170 days (range 61 – 254). After extraction only one patient had early recurrent stricture and received the same stent again. Three stents showed minimal tissue granulation at the papilla. One stent presented ingrowth at the proximal end and was removed after implantation of a second fully covered stent. Mechanical examination revealed significantly lower radial expansion force of the new stent as compared to the cylindrical stent. Conclusions: The new stent design has a low rate of migration. Biomechanical properties may explain this effect. PMID:26793789

  20. Three cases of endoscopic resection for synchronous early colon cancers after self-expandable metallic stent placement for obstructive colon cancer

    PubMed Central

    Moroi, Rintaro; Endo, Katsuya; Ichikawa, Ryo; Takahashi, So; Shiroki, Takeharu; Shinkai, Hirohiko; Ishiyama, Fumitake; Kayaba, Shoichi

    2016-01-01

    Background and study aims: The feasibility of endoscopic resection for synchronous early colon cancer after placement of self-expandable metallic stents (SEMS) for malignant colorectal obstruction is unknown. Herein we evaluated 3 cases of endoscopic resection for synchronous early colorectal cancers after SEMS placement. Patient 1 was an 82-year-old man with obstructive sigmoid colon cancer. We curatively treated the synchronous descending colon cancer with endoscopic submucosal dissection (ESD) and the rectal cancer with endoscopic mucosal resection (EMR) after SEMS placement. This is the first reported case of a successful ESD for synchronous early colon cancer via the use of a colonic stent. Patient 2 was an 81-year-old man with obstructive ascending colon cancer. We resected the synchronous transverse colon cancer via ESD. Histologic findings indicated that the carcinoma cells had invaded the submucosal layer. Therefore, we immediately performed expanded right-hemicolectomy. Patient 3 was an 81-year-old man with obstructive sigmoid colon cancer. We curatively treated the synchronous transverse colon cancer with EMR after SEMS placement. There were no complications associated with the endoscopic treatments in any of the cases. Our results indicate that preoperative endoscopic resection combined with the ESD technique for synchronous colorectal cancer after SEMS placement could be effective as a surgical strategy for patients with malignant colorectal obstruction. PMID:27652303

  1. An equivalent strain/Coffin-Manson approach to multiaxial fatigue and life prediction in superelastic Nitinol medical devices.

    PubMed

    Runciman, Amanda; Xu, David; Pelton, Alan R; Ritchie, Robert O

    2011-08-01

    Medical devices, particularly endovascular stents, manufactured from superelastic Nitinol, a near-equiatomic alloy of Ni and Ti, are subjected to complex mixed-mode loading conditions in vivo, including axial tension and compression, radial compression, pulsatile, bending and torsion. Fatigue lifetime prediction methodologies for Nitinol, however, are invariably based on uniaxial loading and thus fall short of accurately predicting the safe lifetime of stents under the complex multiaxial loading conditions experienced physiologically. While there is a considerable body of research documented on the cyclic fatigue of Nitinol in uniaxial tension or bending, there remains an almost total lack of comprehensive fatigue lifetime data for other loading conditions, such as torsion and tension/torsion. In this work, thin-walled Nitinol tubes were cycled in torsion at various mean and alternating strains to investigate the fatigue life behavior of Nitinol and results compared to equivalent fatigue data collected under uniaxial tensile/bending loads. Using these strain-life results for various loading modes and an equivalent referential (Lagrangian) strain approach, a strategy for normalizing these data is presented. Based on this strategy, a fatigue lifetime prediction model for the multiaxial loading of Nitinol is presented utilizing a modified Coffin-Manson approach where the number of cycles to failure is related to the equivalent alternating transformation strain.

  2. Intravenous magnesium in experimental stent thrombosis in swine.

    PubMed

    Rukshin, V; Azarbal, B; Shah, P K; Tsang, V T; Shechter, M; Finkelstein, A; Cercek, B; Kaul, S

    2001-09-01

    We investigated the effects of magnesium on acute platelet-dependent stent thrombosis in an ex vivo porcine arteriovenous shunt model of high-shear blood flow. Control nitinol stents were expanded to 2 mm in diameter in a tubular perfusion chamber interposed in the shunt and exposed to flowing arterial blood at a shear rate of 2100 s(-1) for 20 minutes (n=156 perfusion runs in 10 swine). Animals were treated with intravenous heparin or MgSO(4) alone (2 g bolus over 20 minutes, followed by 2 g/h infusion) and combined heparin plus MgSO(4) in random fashion. Effects on thrombus weight (TW), platelet aggregation, bleeding time, activated clotting time, mean arterial blood pressure, and heart rate were quantified. Data points in the magnesium-treated animals were examined within 20 minutes after bolus (Mg-early) and >40 minutes after bolus (Mg-late). Stent TW (20+/-3 mg, pretreatment) was reduced by 42+/-21%, 47+/-19%, 48+/-16%, 67+/-12%, and 86+/-8% in the groups treated with Mg-early alone, Mg-late alone, heparin alone, heparin+Mg-early, and heparin+Mg-late, respectively (all P<0.001 versus pretreatment, P<0.001 for heparin+Mg-early and Mg-late versus heparin or magnesium alone, and P<0.05 for heparin+Mg-late versus heparin+Mg-early, ANOVA). Magnesium had no significant effect on platelet aggregation, activated clotting time, or bleeding time. There were no significant effects on heart rate or mean arterial blood pressure. The serum magnesium level was inversely correlated with TW (r=-0.70, P=0.002). In conclusion, treatment with intravenous MgSO(4) produced a time-dependent inhibition of acute stent thrombosis under high-shear flow conditions without any hemostatic or significant hemodynamic complications. Thus, magnesium may be an effective agent for preventing stent thrombosis.

  3. Future developments in biliary stenting

    PubMed Central

    Hair, Clark D; Sejpal, Divyesh V

    2013-01-01

    Biliary stenting has evolved dramatically over the past 30 years. Advancements in stent design have led to prolonged patency and improved efficacy. However, biliary stenting is still affected by occlusion, migration, anatomical difficulties, and the need for repeat procedures. Multiple novel plastic biliary stent designs have recently been introduced with the primary goals of reduced migration and improved ease of placement. Self-expandable bioabsorbable stents are currently being investigated in animal models. Although not US Food and Drug Administration approved for benign disease, fully covered self-expandable metal stents are increasingly being used in a variety of benign biliary conditions. In malignant disease, developments are being made to improve ease of placement and stent patency for both hilar and distal biliary strictures. The purpose of this review is to describe recent developments and future directions of biliary stenting. PMID:23837001

  4. A Case of Aorto-Bronchial Fistula After Insertion of Left Main Bronchial Self-Expanding Metallic Stent in a Patient with Recurrent Esophageal Cancer

    SciTech Connect

    Onishi, Hiroshi Kuriyama, Kengo; Komiyama, Takafumi; Tanaka, Shiho; Marino, Kan; Tsukamoto, Tatsuaki; Araki, Tsutomu

    2004-09-15

    We report a case of aorto-bronchial fistula (ABF) caused by a self-expanding metallic stent (EMS) 51 days after insertion into the left main bronchus. The patient presented with left main bronchial stenosis caused by post-operative local recurrence of esophageal cancer. Post-operative radio therapy totaling 40 Gy and post-recurrence radiotherapy totaling 34 Gy were administered, with daily fractions of 2 Gy. Stenosis of the left main bronchus improved slightly, and was followed with insertion of EMS to prevent re-stenosis. The patient experienced massive hemoptysis for 3 days before sudden death. Autopsy revealed the EMS edge perforating the descending aortic lumen. Tumor infiltration and bacterial infection were observed on the wall of the left bronchus, and atherosclerosis was present on the aortic wall around the fistula. It should be noted that the left main bronchus was at considerable risk of ABF after insertion of EMS for malignant stenosis, and prophylactic stent insertion into the bronchus without imperative need must be avoided.

  5. The Effect of Material Removal on the Corrosion Resistance and Biocompatibility of Nitinol Laser-Cut and Wire-Form Products

    NASA Astrophysics Data System (ADS)

    Decker, Jennifer Fino; Trépanier, Christine; Vien, Lot; Pelton, Alan R.

    2011-07-01

    Laser cutting and wire forming are two of the most commonly used processes in the manufacture of Nitinol medical devices. This study explores how varying the amount of material removed during the final surface treatment steps affects the corrosion resistance of Z-type stents that have either been laser-cut from tube or shape set from wire. All parts were subjected to a typical heat treatment process necessary to achieve an Austenite finish (Af) temperature of 25 ± 5 °C, and were subsequently post-processed with an electrochemical passivation process. The total weight loss during post-processing was recorded and the process adjusted to create groups with less than 5%, less than 10%, and less than 25% amounts of weight loss. The parts were then crimped to 6 mm and allowed to expand back to their original diameter. The corrosion test results showed that on average both groups of Z-stents experienced an increase in the corrosion breakdown potential and a decrease in the standard deviation with increasing amounts of material removal. In addition, less material removal is required from the wire-form Z-stents as compared to the laser-cut Z-stents to achieve high corrosion resistance. Finally, 7 day nickel ion release tests performed on the wire-formed Z-stents showed a dramatic decrease from 0.0132 mg of nickel leached per day for the low weight loss group to approximately 0.001 mg/day for the medium and high weight loss groups.

  6. A Case of Late Femoral Pseudoaneurysm Caused by Stent Disconnection

    SciTech Connect

    Rivolta, Nicola; Fontana, Federico; Piffaretti, Gabriele Tozzi, Matteo; Carrafiello, Gianpaolo

    2010-10-15

    We present the case of a late superficial femoral artery stent disconnection causing an asymptomatic pseudoaneurysm successfully treated with a stent-graft. A 67-year-old female was referred to our department for evaluation of claudication of the left lower limb and was diagnosed to have a total occlusion of the superficial femoral artery. Three nitinol stents were used to revascularize this artery. At 48 months, duplex-ultrasonography control revealed the presence of a 45-mm saccular femoral dilatation; X-rays and CT angiography showed fractures of the proximal stents and the presence of a pseudoaneurysm at the site of the distal stents disconnection. The pseudoaneurysm was excluded using two stent-grafts. We conclude that patients and surgeons should be aware of structural complications with all stents. Rigorous follow-up controls should be mandatory. Endovascular repair proved to be feasible and durable to manage a previous endovascular procedure.

  7. The development of an in vitro test method for predicting the abrasion resistance of textile and metal components of endovascular stent grafts.

    PubMed

    Yao, Tong; Choules, Brian D; Rust, Jon P; King, Martin W

    2014-04-01

    Implantable endovascular stent grafts have become a frequent option for the treatment of abdominal and thoracic aneurysms. Given that such devices are permanent implants, the question of long-term biostability needs to be addressed. This article describes the development of an in vitro stent graft abrasion test method between the graft fabric and metal stent of an endovascular device. Three endpoints were established to determine the abrasion resistance between the fabric and stent surfaces after a predetermined number of abrasion cycles. During initial testing, two types of graft fabric materials, multifilament woven polyester fabric and monofilament woven polyester fabric, and two types of stent materials, laser cut nitinol stents and regular nitinol stent wire, were evaluated under dry and wet conditions. The results have shown that this test method is viable for testing the relative abrasion resistance of the components of endovascular stent grafts. The abrasion resistance of both fabrics was lower in a wet environment compared to being tested dry. Additionally, the multifilament polyester fabric had better abrasion resistance than the monofilament polyester fabric. The laser cut nitinol stent was more aggressive in creating holes and breaking yarns, while the regular nitinol stent wire caused a greater loss in fabric strength.

  8. Gastrointestinal Stent Update

    PubMed Central

    2010-01-01

    The use of self-expanding metallic stents in the upper gastrointestinal tract, placed under radiologic imaging or endoscopic guidance, is the current treatment of choice for the palliation of malignant gastrointestinal outlet obstructions. Advances in metallic stent design and delivery systems have progressed to the stage where this treatment is now considered a minimally invasive therapy. Metallic stent placement will broaden further into the field of nonsurgical therapy for the gastrointestinal tract. To date, metallic stents placed in the esophagus, gastric outlet, colorectum, and bile ducts are not intended to be curative, but rather to provide a palliative treatment for obstructions. The evolution of metallic stent technology will render such procedures not only palliative but also therapeutic, by enabling local drug delivery, and the use of biodegradable materials will reduce procedure-related complications. PMID:21103290

  9. Comparative study of the corrosion behavior of peripheral stents in an accelerated corrosion model: experimental in vitro study of 28 metallic vascular endoprostheses

    PubMed Central

    Paprottka, Karolin J.; Paprottka, Philipp M.; Reiser, Maximilian F.; Waggershauser, Tobias

    2015-01-01

    PURPOSE Clinical cases of stent-fractures show that corrosion behavior might play a role in these fractures. Implanted in vivo, especially in combination with other implanted foreign materials, these metallic products are exposed to special conditions, which can cause a process of corrosion. Here, we aimed to test the corrosion potential of stents made of different materials in an in vitro setting. METHODS A total of 28 peripheral stents of different materials (nitinol, cobalt-chromium-nickel, tantalum, V4A) and surface treatments (electropolish, mechanical polish, no polish) were tested in vitro. Corrosion was accelerated by applying a constant voltage of 3.5 V and amperage of 1.16 mA in 0.9% NaCl. RESULTS Nitinol stents showed the lowest susceptibility to corrosion and the longest period without damage. The Memotherm II® (BARD Angiomed®) was the only stent that showed neither macroscopic nor microscopic damages. The worst performing material was cobalt-chromium-nickel, which showed corrosion damages about ten times earlier compared to nitinol. Considering the reasons for termination of the test, nitinol stents primarily showed length deficits, while V4A and tantalum stents showed fractures. Cobalt-chromium-nickel stents had multiple fractures or a complete lysis in equal proportions. When placed in direct contact, nitinol stents showed best corrosion resistance, regardless of what material they were combined with. In terms of polishing treatments, electropolished stents performed the best, mechanical-polished stents and those without polishing treatment followed. CONCLUSION The analysis of corrosion behavior may be useful to select the right stent fulfilling the individual needs of the patient within a large number of different stents. PMID:26268301

  10. Surface modification of Ni–Ti alloys for stent application after magnetoelectropolishing

    PubMed Central

    Musaramthota, Vishal; Munroe, Norman; Datye, Amit; Dua, Rupak; Haider, Waseem; McGoron, Anthony; Rokicki, Ryszard

    2015-01-01

    The constant demand for new implant materials and the multidisciplinary design approaches for stent applications have expanded vastly over the past decade. The biocompatibility of these implant materials is a function of their surface characteristics such as morphology, surface chemistry, roughness, surface charge and wettability. These surface characteristics can directly influence the material's corrosion resistance and biological processes such as endothelialization. Surface morphology affects the thermodynamic stability of passivating oxides, which renders corrosion resistance to passivating alloys. Magnetoelectropolishing (MEP) is known to alter the morphology and composition of surface films, which assist in improving corrosion resistance of Nitinol alloys. This work aims at analyzing the surface characteristics of MEP Nitinol alloys by scanning electron microscopy (SEM) and X-ray photoelectron spectroscopy (XPS). The wettability of the alloys was determined by contact angle measurements and the mechanical properties were assessed by Nanoindentation. Improved mechanical properties were observed with the addition of alloying elements. Cyclic potentiodynamic polarization tests were performed to determine the corrosion susceptibility. Further, the alloys were tested for their cytotoxicity and cellular growth with endothelial cells. Improved corrosion resistance and cellular viability were observed with MEP surface treated alloys. PMID:25746243

  11. Surface modification of Ni-Ti alloys for stent application after magnetoelectropolishing.

    PubMed

    Gill, Puneet; Musaramthota, Vishal; Munroe, Norman; Datye, Amit; Dua, Rupak; Haider, Waseem; McGoron, Anthony; Rokicki, Ryszard

    2015-05-01

    The constant demand for new implant materials and the multidisciplinary design approaches for stent applications have expanded vastly over the past decade. The biocompatibility of these implant materials is a function of their surface characteristics such as morphology, surface chemistry, roughness, surface charge and wettability. These surface characteristics can directly influence the material's corrosion resistance and biological processes such as endothelialization. Surface morphology affects the thermodynamic stability of passivating oxides, which renders corrosion resistance to passivating alloys. Magnetoelectropolishing (MEP) is known to alter the morphology and composition of surface films, which assist in improving corrosion resistance of Nitinol alloys. This work aims at analyzing the surface characteristics of MEP Nitinol alloys by scanning electron microscopy (SEM) and X-ray photoelectron spectroscopy (XPS). The wettability of the alloys was determined by contact angle measurements and the mechanical properties were assessed by Nanoindentation. Improved mechanical properties were observed with the addition of alloying elements. Cyclic potentiodynamic polarization tests were performed to determine the corrosion susceptibility. Further, the alloys were tested for their cytotoxicity and cellular growth with endothelial cells. Improved corrosion resistance and cellular viability were observed with MEP surface treated alloys.

  12. Electro and Magneto-Electropolished Surface Micro-Patterning on Binary and Ternary Nitinol

    PubMed Central

    Munroe, Norman; McGoron, Anthony

    2012-01-01

    In this study, an Atomic Force Microscopy (AFM) roughness analysis was performed on non-commercial Nitinol alloys with Electropolished (EP) and Magneto-Electropolished (MEP) surface treatments and commercially available stents by measuring Root-Mean-Square (RMS), Average Roughness (Ra), and Surface Area (SA) values at various dimensional areas on the alloy surfaces, ranging from (800 × 800 nm) to (115 × 115μm), and (800 × 800 nm) to (40 × 40 μm) on the commercial stents. Results showed that NiTi-Ta 10 wt% with an EP surface treatment yielded the highest overall roughness, while the NiTi-Cu 10 wt% alloy had the lowest roughness when analyzed over (115 × 115 μm). Scanning Electron Microscopy (SEM) and Energy Dispersive Spectroscopy (EDS) analysis revealed unique surface morphologies for surface treated alloys, as well as an aggregation of ternary elements Cr and Cu at grain boundaries in MEP and EP surface treated alloys, and non-surface treated alloys. Such surface micro-patterning on ternary Nitinol alloys could increase cellular adhesion and accelerate surface endothelialization of endovascular stents, thus reducing the likelihood of in-stent restenosis and provide insight into hemodynamic flow regimes and the corrosion behavior of an implantable device influenced from such surface micro-patterns. PMID:22754200

  13. Stent-in-stent through a side hole to prevent biliary metallicstent migration.

    PubMed

    Ridtitid, Wiriyaporn; Rerknimitr, Rungsun; Amornsawadwattana, Surachai; Ponauthai, Yuwadee; Kullavanijaya, Pinit

    2011-03-16

    The covered self-expandable metallic stent (SEMS) has been developed to overcome the problem of tissue in-growth, However, stent migration is a well-known com--plication of covered SEMS placement. Use of a double pigtail stent to lock the movement of the SEMS and prevent migration has been advised by many ex-perts. Unfortunately, in our case this technique led to an in-cidental upward migration of the SEMS. We used APC to create a side hole in the SEMS for plastic stent insertion as stent-in-stent. This led to a successful pre-ven-tion of stent migration.

  14. PulmoStent: In Vitro to In Vivo Evaluation of a Tissue Engineered Endobronchial Stent.

    PubMed

    Thiebes, Anja Lena; Kelly, Nicola; Sweeney, Caoimhe A; McGrath, Donnacha J; Clauser, Johanna; Kurtenbach, Kathrin; Gesche, Valentine N; Chen, Weiluan; Kok, Robbert Jan; Steinseifer, Ulrich; Bruzzi, Mark; O'Brien, Barry J; McHugh, Peter E; Jockenhoevel, Stefan; Cornelissen, Christian G

    2017-04-01

    Currently, there is no optimal treatment available for end stage tumour patients with airway stenosis. The PulmoStent concept aims on overcoming current hurdles in airway stenting by combining a nitinol stent with a nutrient-permeable membrane, which prevents tumour ingrowth. Respiratory epithelial cells can be seeded onto the cover to restore mucociliary clearance. In this study, a novel hand-braided dog bone stent was developed, covered with a polycarbonate urethane nonwoven and mechanically tested. Design and manufacturing of stent and cover were improved in an iterative process according to predefined requirements for permeability and mechanical properties and finally tested in a proof of concept animal study in sheep for up to 24 weeks. In each animal two stents were implanted, one of which was cell-seeded by endoscopic spraying in situ. We demonstrated the suitability of this membrane for our concept by glucose transport testing and in vitro culture of respiratory epithelial cells. In the animal study, no migration occurred in any of the twelve stents. There was only mild granulation tissue formation and tissue reaction; no severe mucus plugging was observed. Thus, the PulmoStent concept might be a step forward for palliative treatment of airway stenosis with a biohybrid stent device.

  15. Enhanced Biocompatibility of Porous Nitinol

    PubMed Central

    Munroe, Norman; Pulletikurthi, Chandan; Haider, Waseem

    2009-01-01

    Porous Nitinol (PNT) has found vast applications in the medical industry as interbody fusion devices, synthetic bone grafts, etc. However, the tendency of the PNT to corrode is anticipated to be greater as compared to solid nitinol since there is a larger surface area in contact with body fluids. In such cases, surface preparation is known to play a major role in a material’s biocompatibility. In an effort to check the effect of surface treatments on the in vitro corrosion properties of PNT, in this investigation, they were subjected to different surface treatments such as boiling in water, dry heating, and passivation. The localized corrosion resistance of alloys before and after each treatment was evaluated in phosphate buffer saline solution (PBS) using cyclic polarization tests in accordance with ASTM F 2129-08. PMID:19956797

  16. Self-expanding plastic esophageal stents versus jejunostomy tubes for the maintenance of nutrition during neoadjuvant chemoradiation therapy in patients with esophageal cancer: a retrospective study.

    PubMed

    Siddiqui, A A; Glynn, C; Loren, D; Kowalski, T

    2009-01-01

    In patients undergoing chemoradiotherapy for esophageal cancer, the inability to eat may severely impair nutritional status. We conducted a retrospective study to compare the efficacy of the Polyflex self-expanding silicone stent (PS) versus a jejunostomy tube (JT) for maintaining nutrition during neoadjuvant chemoradiation therapy in patients with esophageal cancer who were scheduled for resectional surgery. Thirty-six patients were treated either with PS placement (12 patients) or JT placement (24 patients) prior to receiving an 8-week course of chemoradiation therapy. Patients were interviewed weekly until cessation of therapy. Patient data were collected on procedural success and complication rates, nutritional status, and dysphagia scores. PS placement was successful in 11 of 12 patients (92%), and those 11 patients were able to resume oral nutrition. Dysphagia scores improved from a mean of 3 to 1 in the PS group (P < 0.005) but did not change significantly in the JT group. PS were removed endoscopically without complications prior to the esophagectomies. Albumin levels and weight increased significantly in both the PS and JT groups. There were no significant differences between groups in the procedural success rates (PS 92% vs. JT 100%, P = 0.33), complication rates (PS 22% vs. JT 4%, P = 0.11), mean increase in weight (PS 4.4 kg vs. JT 4.2 kg, P = 0.59), and mean increase in serum albumin (PS 0.62 g/dL vs. JT 0.44 g/dL, P = 0.05). PS is a safe and effective alternative to a surgical JT for maintaining nutrition in this subset of patients.

  17. Fibronectin modulates osteoblast behavior on Nitinol.

    PubMed

    Muhonen, V; Fauveaux, C; Olivera, G; Vigneron, P; Danilov, A; Nagel, M-D; Tuukkanen, J

    2009-03-01

    We have previously demonstrated that primary rat osteoclasts behave differently when cultured on austenite and martensite Nitinol. In this study, we coated the two phases of Nitinol with plasma fibronectin and studied if this modifies the proliferation and cell cycle of MC3T3-E1 osteoblasts. The influence of the crystalline structure of Nitinol on the remodeling and conformation of fibronectin was also studied. The results on austenite demonstrated that fibronectin was more strongly remodeled and the cells spread better compared with the martensite phase. Interestingly, the conformation of the protein showed no differences between austenite and martensite. In addition, fibronectin improved cell proliferation in both phases, but the effect of fibronectin coating was stronger on the austenite surface. In addition, in both Nitinol phases, the proportion of cells in the G(1) phase was observed to grow in the presence of fibronectin. This could indicate cell differentiation on Nitinol.

  18. Single and Tandem Stents in Sheep Iliac Arteries: Is There a Difference in Patency?

    SciTech Connect

    Schuermann, Karl; Vorwerk, Dierk; Buecker, Arno; Grosskortenhaus, Stefanie; Guenther, Rolf W.

    1998-09-15

    Purpose: To compare patency and neointima formation of single and tandem arterial stents. Methods: In each of six sheep, two Memotherm nitinol stents (tandem stents) were inserted into the external iliac artery on one side and a single stent into the artery on the opposite side. The size of the iliac lumen was assessed in the proximal, middle, and distal segments of the stents by intravascular ultrasound (IVUS) before, immediately after, and 1 month after implantation when the sheep were killed. Neointimal thickness was determined in the proximal, middle, and distal segments of each stent by light microscopy. Results: All stents remained patent. There was no significant difference in lumen and neointimal thickness between single and tandem stents. Cranial tandem stents showed a significantly wider lumen and smaller neointimal thickness than caudal tandem stents. In the proximal and distal segments, the lumen of the stents was significantly smaller and the neointimal thickness greater than in the middle segment; differences in neointimal thickness were significant only between the proximal and the middle segment. Conclusion: In an experimental setting, tandem stents did not interfere with one another with regard to patency and neointima formation when compared with a single contralateral stent. Neointimal thickening after stent insertion seems to be inversely related to the original arterial diameter.

  19. A new flow diverter stent for direct treatment of intracranial aneurysm.

    PubMed

    Ma, Jiayao; You, Zhong; Peach, Thomas; Byrne, James; Rizkallah, Rafik R

    2015-12-16

    The use of a stand-alone flow diverter (FD) stent has demonstrated itself as an efficacious endovascular approach to intracranial aneurysm treatment. FD stents that are currently available adopt an interwoven braided design. The relatively low radial stiffness intrinsic to this design could cause difficulty in deployment and poor stent-wall apposition, leading to high complication rates. A new FD stent is proposed to overcome the problems of the interwoven FD stents. The new device is manufactured from a Nitinol tube through a laser-cutting technique, and its unique structure allows for both low porosity and high packaging efficiency. Computational simulation using Abaqus has been conducted to investigate the radial stiffness and longitudinal flexibility of the new device. The new device exhibits high radial stiffness when compared to interwoven FD stents and superior longitudinal flexibility. Results from on-going in-vivo experiments and CFD simulations have also demonstrated the efficacy of the new device as a FD stent.

  20. NITINOL Interconnect Device for Optical Fiber Waveguides

    DTIC Science & Technology

    1981-07-01

    LE EL,~NAVSEA REPORT NO. S27L~kV-NL 4P fNSWNC TR 81-129 1 JULY 1981 0 NITINOL INTERC&INECT DEVICE FOR OPTICAL FIBER WAVEGUIDES FINAL REPORT A...ACCESSION NO. 3. RECIPIENT’S CATALOG NUMBER NSWC TR 81-129I 1-19 -A )ci , ’ 4 TI TL E (and Sbtitle) S. TYPE OF REPORT & PERIOD COVERED NITINOL ... NITINOL Optical Fibers 20. ABSTRACT (Continue on reverse side if neceeewy and identify by block number) Two different interconnect devices for optical

  1. Use of a novel covered self-expandable metal stent with an anti-migration system for endoscopic ultrasound-guided drainage of a pseudocyst

    PubMed Central

    Téllez-Ávila, Félix Ignacio; Villalobos-Garita, Álvaro; Ramírez-Luna, Miguel Ángel

    2013-01-01

    The development of pseudocysts in patients with chronic pancreatitis has been reported in 23%-60% of cases and drainage is indicated when they become symptomatic. Endoscopic ultrasound-guided drainage with the placement of plastic or metallic stents to create a cystogastric anastomosis has been shown to be a reliable and efficacious maneuver. Metallic stent use appears to be a safe and effective alternative that shortens the length of time of the procedure and maintains a greater diameter in the cystogastric communication. However, important migration rates have been reported. The use of new metallic stents that are specially designed to prevent migration represents a promising development in the treatment of these group of patients that appears to be safe and effective for pseudocyst drainage and could importantly reduce migration rates, while at the same time having the advantage of a single step procedure and a larger fistula diameter in the endoscopic cystogastric anastomosis. PMID:23772268

  2. Upper Gastrointestinal Stent Insertion in Malignant and Benign Disorders

    PubMed Central

    Kang, Hyoun Woo

    2015-01-01

    Upper gastrointestinal (GI) stents are increasingly being used to manage upper GI obstructions. Initially developed for palliative treatment of esophageal cancer, upper GI stents now play an emerging role in benign strictures of the upper GI tract. Because recurrent obstruction and stent-related complications are common, new modifications of stents have been implemented. Self-expandable metal stents (SEMS) have replaced older plastic stents. In addition, newly designed SEMS have been developed to prevent complications. This review provides an overview of the various types, indications, methods, complications, and clinical outcomes of upper GI stents in a number of malignant and benign disorders dividing the esophagus and gastroduodenum. PMID:26064817

  3. Mechanical behavior of peripheral stents and stent-vessel interaction: A computational study

    NASA Astrophysics Data System (ADS)

    Dottori, Serena; Flamini, Vittoria; Vairo, Giuseppe

    2016-05-01

    In this paper stents employed to treat peripheral artery disease are analyzed through a three-dimensional finite-element approach, based on a large-strain and large-displacement formulation. Aiming to evaluate the influence of some stent design parameters on stent mechanics and on the biomechanical interaction between stent and arterial wall, quasi-static and dynamic numerical analyses are carried out by referring to computational models of commercially and noncommercially available versions of both braided self-expandable stents and balloon-expandable stents. Addressing isolated device models, opening mechanisms and flexibility of both opened and closed stent configurations are numerically experienced. Moreover, stent deployment into a stenotic peripheral artery and possible postdilatation angioplasty (the latter for the self-expandable device only) are simulated by considering different idealized vessel geometries and accounting for the presence of a stenotic plaque. Proposed results highlight important differences in the mechanical response of the two types of stents, as well as a significant influence of the vessel shape on the stress distributions arising upon the artery-plaque system. Finally, computational results are used to assess both the stent mechanical performance and the effectiveness of the stenting treatment, allowing also to identify possible critical conditions affecting the risk of stent fracture, tissue damage, and/or pathological tissue response.

  4. Endoscopic esophageal self-expanding stent implantation WallFlex™ (Boston Scientific) in the management of a gastrocutaneous fistula, as a complication of sleeve bariatric gastrectomy.

    PubMed

    Janczak, Dariusz; Pawłowski, Wiktor; Ziomek, Agnieszka; Dorobisz, Tadeusz; Janczak, Dawid; Janus, Werner; Chabowski, Mariusz

    2015-06-01

    The study presented a case of a gastrocutaneous fistula, as a result of bariatric sleeve gastrectomy. The discussion considered the main pathogenesis, etiology, diagnostics and endoscopic treatment using the implantation of covered esophageal stents. Special attention was placed upon the multifactorial origin of this life-threatening clinical condition, typical for bariatric surgery.

  5. Percutaneous cholangioscopy in obstructed biliary metal stents

    SciTech Connect

    Hausegger, Klaus A.; Mischinger, Hans J.; Karaic, Radenko; Klein, Guenther E.; Kugler, Cristian; Kern, Robert; Uggowitzer, Martin; Szolar, Dieter

    1997-05-15

    Purpose. To reevaluate the reasons for the occlusion of self-expanding biliary metal stents, on the basis of cholangioscopic findings. Methods. Percutaneous transhepatic cholangioscopy (PTCS) was performed in 15 patients with obstructed biliary Wallstents. The reason for stent insertion was a malignant obstruction in 14 patients; 1 had a benign biliary stricture. Conventional noncovered stents had been inserted in 12 patients; in 3 cases a polyurethane-covered prototype Wallstent had been used. Stent occlusions occurred after 1-55 months. PTCS was performed with a 2.3-mm endoscope through an 11 Fr sheath. Biopsies were taken via the working channel of the endoscope. Results. In all patients with noncovered stents the inner surface of the stent was highly irregular with seaweed-like protrusions (biopsy-proven granulation tissue). Stent incorporation varied from absent (n=1) to subtotal (n=8), but was always incomplete, no matter how long the stent had been in place. Tumor ingrowth was histologically proven in 2 patients. One patient had a large occluding concrement at the proximal end of the stent. In patients with covered stents, the inner surface appeared more regular; however, viable granulation tissue was found inside two stents and tumor ingrowth in one of them. Conclusion. PTCS showed that incorporation of the stent is virtually always incomplete. The factors contributing most to stent occlusion are the buildup of granulation tissue, bile sludge, and tumor overgrowth. Stone formation and tumor ingrowth can also be important, although less common causes of occlusion. A polyurethane stent covering could not prevent tumor ingrowth in one patient and the buildup of viable granulation tissue inside the stent in two further patients; mean stent patency in the three patients with such a stent was 3 months.

  6. Percutaneous Endoluminal Stent and Stent-Graft Placement for the Treatment of Femoropopliteal Aneurysms: Early Experience

    SciTech Connect

    Mueller-Huelsbeck, Stefan; Link, Johann; Schwarzenberg, Helmut; Walluscheck, Knut P.; Heller, Martin

    1999-03-15

    Purpose: To determine the efficacy of percutaneous endoluminal stents and stent-grafts for the treatment of isolated femoropopliteal aneurysms. Methods: Seven men (age 51-69 years) with femoropopliteal occlusions (n= 6) related to aneurysms and a patent femoropopliteal aneurysm (n= 1) were treated percutaneously. In two patients uncovered Wallstents and in five patients polyester-covered nitinol stents were implanted. Assessment was performed with Doppler ultrasound and duplex ultrasonography 24 hr, 1, 3, 6, 12, and 24 months after the intervention. Additionally, intraarterial angiography was performed at 6 months. Results: Stent placement succeeded in all cases. No immediate adjunctive surgical treatment was necessary. Ankle-brachial index (ABI) improved from 0.29 {+-} 0.29 (SD) before to 0.78 {+-} 0.23 (SD) 24 hr after the intervention. One patient was lost to follow-up. Stent-graft occlusion occurred in four patients: after 2 days (n1), 1 month (n= 2), and 3 months (n= 1). One of the patients, whose stent occluded at 1 month, underwent successful recanalization with local fibrinolysis therapy. Three of the seven, all with three-vessel run-off, demonstrated patency of the stent, which was assessed by duplex ultrasonography at 29, 31, and 34 months. Breaking of the stent struts or significant stent migration was not observed. Conclusions: These results in a small number of patients warrant further investigation to evaluate the role of percutaneous stents in femoropopliteal aneurysms. Until further data of clinical studies are available, this method cannot be recommended, and it cannot replace surgical treatment.

  7. Evaluation of the compressive mechanical properties of endoluminal metal stents.

    PubMed

    Schrader, S C; Beyar, R

    1998-06-01

    The mechanical properties of metal stents are important parameters in the consideration of stent design, matched to resist arterial recoil and vascular spasm. The purpose of this study was to develop a system for a standardized quantitative evaluation of the mechanical characteristics of various coronary stents. Several types of stents were compressed by external hydrostatic pressure. The stent diameter was assessed by placing a pair of small ultrasonic sono-crystals on the stent. From pressure-strain diagrams the ultimate strength and radial stiffness for each stent were determined. For all stents, except the MICRO-II and the Wiktor stent, the diameter decreased homogeneously until an ultimate compressive strength was exceeded, causing an abrupt collapse. Expanded to 3 mm, the mechanical behavior of the beStent, the Crown and the Palmaz-Schatz stent (PS153-series) were comparable. The spiral articulated Palmaz-Schatz stent showed twice the strength (1.26 atm) of the PS-153 (0.65 atm). The NIR stent yielded a maximum strength of 1.05 atm. The MICRO-II and the Wiktor stent did not collapse abruptly but rather showed a continuous decline of diameter with increasing external pressure. The Cardiocoil stent behaved in a fully elastic manner and showed the largest radial stiffness. Difference in mechanical properties between stents were documented using a new device specifically developed for that purpose. These mechanical stent parameters may have important clinical implications.

  8. A statistical approach to understand the role of inclusions on the fatigue resistance of superelastic Nitinol wire and tubing.

    PubMed

    Robertson, Scott W; Launey, Maximilien; Shelley, Oren; Ong, Ich; Vien, Lot; Senthilnathan, Karthike; Saffari, Payman; Schlegel, Scott; Pelton, Alan R

    2015-11-01

    Superelastic wires and diamond-shaped stent surrogates were manufactured from Nitinol rods and tubing, respectively, from five different mill product suppliers - Standard VAR, Standard VIM, Standard VIM+VAR, Process-Optimized VIM+VAR, and High-Purity VAR. High-cycle fatigue tests up to 10(7) cycles were conducted under tension-tension conditions for wires and bending conditions for diamonds. These materials were compared under both testing methods at 37°C with 6% prestrain and 3% mean strain (unloading plateau) with a range of alternating strains. The High-Purity VAR material outperformed all alloys tested with a measured 10(7)-fatigue alternating strain limit of 0.32% for wire and 1.75% for diamonds. Process-Optimized VIM+VAR material was only slightly inferior to the High Purity VAR with a diamond alternating bending strain limit of 1.5%. These two "second generation" Nitinol alloys demonstrated approximately a 2× increase in 10(7)-cycle fatigue strain limit compared to all of the Standard-grade Nitinol alloys (VAR, VIM, and VIM+VAR) that demonstrated virtually indistinguishable fatigue performance. This statistically-significant increase in fatigue resistance in the contemporary alloys is ascribed to smaller inclusions in the Process-Optimized VIM+VAR material, and both smaller and fewer inclusions in the High-Purity VAR Nitinol.

  9. Complete Obliteration of a Basilar Artery Aneurysm after Insertion of a Self-Expandable Leo Stent into the Basilar Artery without Coil Embolization

    PubMed Central

    Nowak, Stanisław; Wieloch, Michał; Zarzecka, Anna

    2008-01-01

    We report a case of a 45-year-old man who underwent endovascular treatment in the acute setting of a subarachnoid hemorrhage due to rupture of a wide-necked basilar trunk aneurysm. The patient was treated with stent implantation without coiling. A control angiographic scan obtained immediately after the procedure revealed significantly decreased intraaneurysmal flow. Follow-up angiography performed after one month demonstrated total aneurysm occlusion. PMID:18682676

  10. Complete obliteration of a basilar artery aneurysm after insertion of a self-expandable Leo stent into the basilar artery without coil embolization.

    PubMed

    Juszkat, Robert; Nowak, Stanisław; Wieloch, Michał; Zarzecka, Anna

    2008-01-01

    We report a case of a 45-year-old man who underwent endovascular treatment in the acute setting of a subarachnoid hemorrhage due to rupture of a wide-necked basilar trunk aneurysm. The patient was treated with stent implantation without coiling. A control angiographic scan obtained immediately after the procedure revealed significantly decreased intraaneurysmal flow. Follow-up angiography performed after one month demonstrated total aneurysm occlusion.

  11. A new removable airway stent

    PubMed Central

    Amundsen, Tore; Sørhaug, Sveinung; Leira, Håkon Olav; Tyvold, Stig Sverre; Langø, Thomas; Hammer, Tommy; Manstad-Hulaas, Frode; Mattsson, Erney

    2016-01-01

    Background Malignant airway obstruction is a feared complication and will most probably occur more frequently in the future because of increasing cancer incidence and increased life expectancy in cancer patients. Minimal invasive treatment using airway stents represents a meaningful and life-saving palliation. We present a new removable airway stent for improved individualised treatment. Methods To our knowledge, the new airway stent is the world's first knitted and uncovered self-expanding metal stent, which can unravel and be completely removed. In an in vivo model using two anaesthetised and spontaneously breathing pigs, we deployed and subsequently removed the stents by unravelling the device. The procedures were executed by flexible bronchoscopy in an acute and a chronic setting – a ‘proof-of-principle’ study. Results The new stent was easily and accurately deployed in the central airways, and it remained fixed in its original position. It was easy to unravel and completely remove from the airways without clinically significant complications. During the presence of the stent in the chronic study, granulation tissue was induced. This tissue disappeared spontaneously with the removal. Conclusions The new removable stent functioned according to its purpose and unravelled easily, and it was completely removed without significant technical or medical complications. Induced granulation tissue disappeared spontaneously. Further studies on animals and humans are needed to define its optimal indications and future use. PMID:27608269

  12. Stent hypersensitivity and infection in sinus cavities

    PubMed Central

    Soufras, George D.; Hahalis, George

    2013-01-01

    Persistent mucosal inflammation, granulation tissue formation, hypersensitivity, and multifactorial infection are newly described complications of retained drug-eluting stents from endoscopic sinus surgery for refractory rhinosinusitis. In an important report published in Allergy and Rhinology, a 45-year-old male patient suffering from recalcitrant chronic rhinosinusitis underwent functional endoscopic sinus surgery and was found, for the first time, to have steroid-eluting catheters that were inadvertently left in the ethmoid and frontal sinuses. The retained catheters had caused persistent mucosal inflammation and formation of granulation tissue denoting hypersensitivity reaction. These consequences had induced perpetuation of symptoms of chronic rhinosinusitis. Meticulous removal of the retained stents with the nitinol wings from inflamed tissues of the frontal, ethmoidal, and sphenoethmoidal recesses in which they were completely imbedded was successfully performed without polypoid regrowth. Cultures of specimens taken from both left and right stents showed heavy growth of Stenotrophomonas maltophilia and moderate growth of Klebsiella oxytoca, coagulase negative Staphylococcus, and beta-hemolytic Streptococcus anginosus. Fungal infection was not detected. The current knowledge and experience regarding stent hypersensitivity and infection in relation with the use of stents in sinus cavities is reviewed. PMID:24498522

  13. A Comparison of Different Nitinol Material Data Sources for Finite Element Analysis

    NASA Astrophysics Data System (ADS)

    Nagl, Frank; Siekmeyer, Gerd; Quellmalz, Michael; Schuessler, Andreas

    2011-07-01

    Nitinol (NiTi) is widely used for minimal invasive vascular implants due to its superelastic material behavior. Today computerized finite element analysis (FEA) modeling is a standard tool for the development of medical devices and an essential part of the product design and device approval process (X. Gong and A.R. Pelton, ABAQUS Analysis on Nitinol Medical Applications, Proceedings of ABAQUS User's Conference, New Port, Rhode Island, 2001, p 1; N. Rebelo and M. Perry, Finite Element Analysis for the Design of Nitinol Medical Devices, Min. Invas. Ther. Allied Technol., 2000, 9(2), p 75). Quality of simulation depends on a multitude of parameters such as the mathematical material model and FE model generation (meshing). As such, a superior material data input is crucial in order to calculate the correct stress and strain conditions. In this study, we used different sources for material data input for our FE simulations. We compared simulated output versus the experimental results using a stent-like structure after various heat treatments. We used NiTi literature data, tensile data from raw as-supplied NiTi tubes as well as tensile and compression data from microtest samples which underwent stent-like processing for our FEA modeling. A FEA model of the diamond shape (DS) was constructed to quantify and visualize the force and motion response after applying different loading conditions similar to physiologic stress and strain. Force-deflection response of the virtual model was compared against the differently processed DS specimen. All results were put into a matrix in order to evaluate the quality of the different inputs for the FEA. The goal of this study was to demonstrate the importance of selecting and applying the correct material parameter inputs and to further show the importance of not just using given parameter, but also calibrating the values to get accurate results of FE simulations.

  14. Hierarchical periodic micro/nano-structures on nitinol and their influence on oriented endothelialization and anti-thrombosis.

    PubMed

    Nozaki, Kosuke; Shinonaga, Togo; Ebe, Noriko; Horiuchi, Naohiro; Nakamura, Miho; Tsutsumi, Yusuke; Hanawa, Takao; Tsukamoto, Masahiro; Yamashita, Kimihiro; Nagai, Akiko

    2015-12-01

    The applications of hierarchical micro/nano-structures, which possess properties of two-scale roughness, have been studied in various fields. In this study, hierarchical periodic micro/nano-structures were fabricated on nitinol, an equiatomic Ni-Ti alloy, using a femtosecond laser for the surface modification of intravascular stents. By controlling the laser fluence, two types of surfaces were developed: periodic nano- and micro/nano-structures. Evaluation of water contact angles indicated that the nano-surface was hydrophilic and the micro/nano-surface was hydrophobic. Endothelial cells aligned along the nano-structures on both surfaces, whereas platelets failed to adhere to the micro/nano-surface. Decorrelation between the responses of the two cell types and the results of water contact angle analysis were a result of the pinning effect. This is the first study to show the applicability of hierarchical periodic micro/nano-structures for surface modification of nitinol.

  15. A simple technique to remove migrated esophageal stents.

    PubMed

    Noyer, C M; Forohar, F

    1998-09-01

    A 51-yr-old man with a tracheoesophageal fistula from an esophageal carcinoma had two expandable covered stents placed, which migrated distally. After several unsuccessful attempts to remove the stents, we fashioned a homemade snare to entrap and remove the stents under endoscopic and fluoroscopic guidance.

  16. Mechanical Properties of Metallic Stents: How Do These Properties Influence the Choice of Stent for Specific Lesions?

    SciTech Connect

    Dyet, John F.; Watts, William G.; Ettles, Duncan F.; Nicholson, Anthony A.

    2000-01-15

    Purpose: To assess selected balloon-expandable and self-expanding stents for radial force, flexibility, radio-opacity, and trackability, and to relate these physical characteristics to potential indications for placement.Methods: Force-strain curves were plotted for each stent and the force required to produce 50% luminal narrowing was recorded. The ability of the stent to show elastic recoil following deformation was also noted. Flexibility was measured by bending the stents against a force transducer and recording the force required per degree of flexion. Radio-opacity was measured by comparing each stent against a standard aluminum step wedge. Trackability was measured by testing the ability of the stent on its delivery system to track over angles of 90 deg. and 60 deg. Results: The balloon-expandable stents showed greater radial strength and radio-opacity but, apart from the AVE Iliac Bridge stent, showed poorer flexibility and trackability. The self-expanding stents showed less radial force but were able to re-expand following deformity. They were generally more flexible and had better trackability but lower radio-opacity.Conclusion: There is no stent which exhibits all the ideal properties required and therefore the interventionist will need to keep a range of stents available if all lesions are to be addressed.

  17. Endoscopic stenting for laparoscopic sleeve gastrectomy leaks

    PubMed Central

    Aydın, Mehmet Timuçin; Alahdab, Yeşim Özen; Aras, Orhan; Karip, Bora; Onur, Ender; İşcan, Yalın; Memişoğlu, Kemal

    2016-01-01

    Objective Laparoscopic sleeve gastrectomy is a widely accepted and effective bariatric surgery method. The rate of leakage at the staple-line has been reported to be between 1.5 and 5%. Aside from the use of percutaneous drainage, re-laparoscopy, or abdominal sepsis control by laparotomy, endoscopic esophagogastric stent placement is increasingly preferred as a treatment method. Because laparoscopic sleeve gastrectomy is a widely used modality in our hospital, we aimed to evaluate the rate of leaks and the results of stent placements in our patients. Material and Methods Between January 1st 2010 and August 31st 2014, laparoscopic sleeve gastrectomy was performed on 236 patients by three surgeons. The demographic information and postoperative discharge summaries were collected and analyzed with the permission of the hospital ethics committee. Information about leak treatment management was also collected. Results Leaks after laparoscopic sleeve gastrectomy in four patients were stented in the first postoperative month. Short (12 cm) Hanora® (M.I.Tech, Gyeonggi-do, Korea) self-expandable coated stents were placed in two patients, and long (24 cm) Hanora® self-expandable coated stents were placed in the other two. The stents were removed after one month in two patients, two and a half months later in one, and five months later in another patient. The leaks were demonstrated to be healed in all patients after stent removal. Endoscopic stent revision was performed in one patient due to migration of the stent and in another for stent breakage. Conclusion The success rate of treatment of leaks after laparoscopic sleeve gastrectomy by stent placement has been variable in the literature. The success in early stent placement has been shown to be related to physician expertise. According to the results of our patients, we suggest that endoscopic stent placement in the early stage after controlling sepsis is an effective method in the management of leaks. PMID:28149125

  18. Microstructured Thin Film Nitinol for a Neurovascular Flow-Diverter

    NASA Astrophysics Data System (ADS)

    Chen, Yanfei; Howe, Connor; Lee, Yongkuk; Cheon, Seongsik; Yeo, Woon-Hong; Chun, Youngjae

    2016-03-01

    A cerebral aneurysm occurs as a result of a weakened blood vessel, which allows blood to flow into a sac or a ballooned section. Recent advancement shows that a new device, ‘flow-diverter’, can divert blood flow away from the aneurysm sac. People found that a flow-diverter based on thin film nitinol (TFN), works very effectively, however there are no studies proving the mechanical safety in irregular, curved blood vessels. Here, we study the mechanical behaviors and structural safety of a novel microstructured TFN membrane through the computational and experimental studies, which establish the fundamental aspects of stretching and bending mechanics of the structure. The result shows a hyper-elastic behavior of the TFN with a negligible strain change up to 180° in bending and over 500% in radial stretching, which is ideal in the use in neurovascular curved arteries. The simulation determines the optimal joint locations between the TFN and stent frame. In vitro experimental test qualitatively demonstrates the mechanical flexibility of the flow-diverter with multi-modal bending. In vivo micro X-ray and histopathology study demonstrate that the TFN can be conformally deployed in the curved blood vessel of a swine model without any significant complications or abnormalities.

  19. Microstructured Thin Film Nitinol for a Neurovascular Flow-Diverter

    PubMed Central

    Chen, Yanfei; Howe, Connor; Lee, Yongkuk; Cheon, Seongsik; Yeo, Woon-Hong; Chun, Youngjae

    2016-01-01

    A cerebral aneurysm occurs as a result of a weakened blood vessel, which allows blood to flow into a sac or a ballooned section. Recent advancement shows that a new device, ‘flow-diverter’, can divert blood flow away from the aneurysm sac. People found that a flow-diverter based on thin film nitinol (TFN), works very effectively, however there are no studies proving the mechanical safety in irregular, curved blood vessels. Here, we study the mechanical behaviors and structural safety of a novel microstructured TFN membrane through the computational and experimental studies, which establish the fundamental aspects of stretching and bending mechanics of the structure. The result shows a hyper-elastic behavior of the TFN with a negligible strain change up to 180° in bending and over 500% in radial stretching, which is ideal in the use in neurovascular curved arteries. The simulation determines the optimal joint locations between the TFN and stent frame. In vitro experimental test qualitatively demonstrates the mechanical flexibility of the flow-diverter with multi-modal bending. In vivo micro X-ray and histopathology study demonstrate that the TFN can be conformally deployed in the curved blood vessel of a swine model without any significant complications or abnormalities. PMID:27009500

  20. Ocular Biocompatibility of Nitinol Intraocular Clips

    PubMed Central

    Velez-Montoya, Raul; Erlanger, Michael

    2012-01-01

    Purpose. To evaluate the tolerance and biocompatibility of a preformed nitinol intraocular clip in an animal model after anterior segment surgery. Methods. Yucatan mini-pigs were used. A 30-gauge prototype injector was used to attach a shape memory nitinol clip to the iris of five pigs. Another five eyes received conventional polypropylene suture with a modified Seipser slip knot. The authors compared the surgical time of each technique. All eyes underwent standard full-field electroretinogram at baseline and 8 weeks after surgery. The animals were euthanized and eyes collected for histologic analysis after 70 days (10 weeks) postsurgery. The corneal thickness, corneal endothelial cell counts, specular microscopy parameters, retina cell counts, and electroretinogram parameters were compared between the groups. A two sample t-test for means and a P value of 0.05 were use for assessing statistical differences between measurements. Results. The injection of the nitinol clip was 15 times faster than conventional suturing. There were no statistical differences between the groups for corneal thickness, endothelial cell counts, specular microscopy parameters, retina cell counts, and electroretinogram measurements. Conclusions. The nitinol clip prototype is well tolerated and showed no evidence of toxicity in the short-term. The injectable delivery system was faster and technically less challenging than conventional suture techniques. PMID:22064995

  1. Additively Manufactured and Surface Biofunctionalized Porous Nitinol.

    PubMed

    Gorgin Karaji, Z; Speirs, M; Dadbakhsh, S; Kruth, J-P; Weinans, H; Zadpoor, A A; Amin Yavari, S

    2017-01-18

    Enhanced bone tissue regeneration and improved osseointegration are among the most important goals in design of multifunctional orthopedic biomaterials. In this study, we used additive manufacturing (selective laser melting) to develop multifunctional porous nitinol that combines superelasticity with a rationally designed microarchitecture and biofunctionalized surface. The rational design based on triply periodic minimal surfaces aimed to properly adjust the pore size, increase the surface area (thereby amplifying the effects of surface biofunctionalization), and resemble the curvature characteristics of trabecular bone. The surface of additively manufactured (AM) porous nitinol was biofunctionalized using polydopamine-immobilized rhBMP2 for better control of the release kinetics. The actual morphological properties of porous nitinol measured by microcomputed tomography (e.g., open/close porosity, and surface area) closely matched the design values. The superelasticity originated from the austenite phase formed in the nitinol porous structure at room temperature. Polydopamine and rhBMP2 signature peaks were confirmed by X-ray photoelectron spectroscopy and Fourier transform infrared spectroscopy tests. The release of rhBMP2 continued until 28 days. The early time and long-term release profiles were found to be adjustable independent of each other. In vitro cell culture showed improved cell attachment, cell proliferation, cell morphology (spreading, spindle-like shape), and cell coverage as well as elevated levels of ALP activity and increased calcium content for biofunctionalized surfaces as compared to as-manufactured specimens. The demonstrated functionalities of porous nitinol could be used as a basis for deployable orthopedic implants with rationally designed microarchitectures that maximize bone tissue regeneration performance by release of biomolecules with adjustable and well-controlled release profiles.

  2. Characterization of Nitinol Laser-Weld Joints by Nondestructive Testing

    NASA Astrophysics Data System (ADS)

    Wohlschlögel, Markus; Gläßel, Gunter; Sanchez, Daniela; Schüßler, Andreas; Dillenz, Alexander; Saal, David; Mayr, Peter

    2015-12-01

    Joining technology is an integral part of today's Nitinol medical device manufacturing. Besides crimping and riveting, laser welding is often applied to join components made from Nitinol to Nitinol, as well as Nitinol components to dissimilar materials. Other Nitinol joining techniques include adhesive bonding, soldering, and brazing. Typically, the performance of joints is assessed by destructive mechanical testing, on a process validation base. In this study, a nondestructive testing method—photothermal radiometry—is applied to characterize small Nitinol laser-weld joints used to connect two wire ends via a sleeve. Two different wire diameters are investigated. Effective joint connection cross sections are visualized using metallography techniques. Results of the nondestructive testing are correlated to data from destructive torsion testing, where the maximum torque at fracture is evaluated for the same joints and criteria for the differentiation of good and poor laser-welding quality by nondestructive testing are established.

  3. Flow Velocities After Carotid Artery Stenting: Impact of Stent Design. A Fluid Dynamics Study in a Carotid Artery Model with Laser Doppler Anemometry

    SciTech Connect

    Greil, Oliver Kleinschmidt, Thomas; Weiss, Wolfgang; Wolf, Oliver; Heider, Peter; Schaffner, Silvio; Gianotti, Marc; Schmid, Thomas; Liepsch, Dieter; Berger, Hermann

    2005-01-15

    Purpose. To study the influence of a newly developed membrane stent design on flow patterns in a physiologic carotid artery model. Methods. Three different stents were positioned in silicone models of the carotid artery: a stainless steel stent (Wall-stent), a nitinol stent (SelfX), and a nitinol stent with a semipermeable membrane (MembraX). To increase the contact area of the membrane with the vessel wall, another MembranX model was modified at the outflow tract. The membrane consists of a biocompatible silicone-polyurethane copolymer (Elast-Eon) with a pore size of 100 {mu}m. All stents were deployed across the bifurcation and the external carotid artery origin. Flow velocity measurements were performed with laser Doppler anemometry (LDA), using pulsatile flow conditions (Re = 220; flow 0.39 l/min; flow rate ratio ICA:ECA = 70:30) in hemodynamically relevant cross-sections. The hemodynamic changes were analyzed by comparing velocity fluctuations of corresponding flow profiles. Results. The flow rate ratio ICA:ECA shifted significantly from 70/30 to 73.9/26.1 in the MembraX and remained nearly unchanged in the SelfX and Wallstent. There were no changes in the flow patterns at the inflow proximal to the stents. In the stent no relevant changes were found in the SelfX. In the Wallstent the separation zone shifted from the orifice of the ICA to the distal end of the stent. Four millimeters distal to the SelfX and the Wallstent the flow profile returned to normal. In the MembraX an increase in the central slipstreams was found with creation of a flow separation distal to the stent. With a modification of the membrane this flow separation vanished. In the ECA flow disturbances were seen at the inner wall distal to the stent struts in the SelfX and the Wallstent. With the MembraX a calming of flow could be observed in the ECA with a slight loss of flow volume. Conclusions. Stent placement across the carotid artery bifurcation induces alterations of the physiologic flow

  4. Effect of Stent Radial Force on Stress Pattern After Deployment: A Finite Element Study

    NASA Astrophysics Data System (ADS)

    Borghi, Alessandro; Murphy, Olive; Bahmanyar, Reza; McLeod, Chris

    2014-07-01

    The present article presents a method for assessing the radial stiffness of nitinol stents. An idealized stent model was created, and its radial stiffness was calculated by means of finite element modeling. The calculations were validated against experimental measurements. The variation of radial stiffness with geometrical dimensions was calculated, and the effect of increasing radial stiffness on endovascular deployment was analyzed. Peak tensile and compressive stresses as well as stent penetration were calculated in the case of an idealized pulmonary artery model having realistic dimensions as well as stiffness. The results of stress calculations were compared with a second set of simulations, where an idealized behavior of the stent (uniform expansion to a theoretical contact diameter) was modeled. The results show how in reality nitinol stents behave in a non-ideal way, having a non-uniform expansion and exerting non-uniform pressure on the contact areas with the artery. Such non-ideality decreases though with the increase in radial stiffness. The radial force alone may be insufficient in describing the stent-artery interaction, and numerical modeling proves to be necessary for capturing such complexity.

  5. Evolution of the passive film on mechanically damaged nitinol.

    PubMed

    Schroeder, Valeska

    2009-07-01

    The corrosion behavior of Nitinol-based medical implants is critical to their success in vivo. Contemporary Nitinol-based medical implants are typically chemically passivated or electrochemically polished to form a protective passive film. However, mechanically formed surfaces caused by handling damage, fretting, or fatigue fracture may also be present on a device in vivo. In this study, mechanically polished surfaces are used to simulate mechanically damaged surfaces such that analytical techniques, including electrochemical impedance spectroscopy, open circuit potential monitoring, X-ray photoelectron spectroscopy (XPS), and Mott-Schottky analysis may be used to monitor the evolution of the passive film on mechanically damaged Nitinol. These mechanically polished Nitinol surfaces are compared with chemically passivated and electrochemically polished Nitinol surfaces and mechanically polished titanium surfaces in phosphate buffered saline solution. The mechanically polished Nitinol exhibits lower impedance at low frequencies, empirically modeled to a thinner film with lower film resistance than chemically passivated and electrochemically polished Nitinol and mechanically polished titanium. Moreover, the passive film on mechanically polished Nitinol continues to develop over time, increasing in its thickness and film resistance. This characterization demonstrates that mechanically formed surfaces may be initially less protective than chemically passivated and electrochemically polished Nitinol surfaces, but continue to become thicker and more resistant to electrochemical reactions with exposure to saline solution.

  6. Treatment of Post-Stent Gastroesophageal Reflux by Anti-Reflux Z-Stent

    SciTech Connect

    Davies, Roger Philip; Kew, Jacqueline; Byrne, Peter D.

    2000-11-15

    Severe symptoms of heartburn and retrosternal pain consistent with gastro-esophageal reflux (GER) developed in a patient following placement of a conventional self-expanding 16-24-mm-diameter x 12-cm-long esophageal stent across the gastroesophageal junction to treat an obstructing esophageal carcinoma. A second 18-mm-diameter x 10-cm-long esophageal stent with anti-reflux valve was deployed coaxially and reduced symptomatic GER immediately. Improvement was sustained at 4-month follow-up. An anti-reflux stent can be successfully used to treat significant symptomatic GER after conventional stenting.

  7. Nitinol-based Nanotubular and Nanowell Coatings for the Modulation of Human Vascular Cell Functions

    NASA Astrophysics Data System (ADS)

    Lee, Phin Peng

    Current approaches to reducing restenosis do not balance the reduction of vascular smooth muscle cell proliferation with the increase in the healing of the endothelium. Here, I present my study on the synthesis and characterization of a nanotubular coating on Nitinol substrates. I found that the coating demonstrated 'pro-healing' properties by increasing primary human aortic endothelial cell spreading, migration and collagen and elastin production. Certain cellular functions such as collagen and elastin production were also found to be affected by changes in nanotube diameter. The coating also reduced the proliferation and mRNA expression of collagen I and MMP2 for primary human aortic smooth muscle cells. I will also demonstrate the synthesis of a nanowell coating on Nitinol stents as well as an additional poly(lactic-co-glycolic acid) coating on top of the nanowells that has the potential for controlling drug release. These findings demonstrate the potential for the coatings to aid in the prevention of restenosis and sets up future explorations of ex vivo and in vivo studies.

  8. Laser Cut Nitinol Tubing Fatigue Coupon: Design, Testing, and Endurance Limit

    NASA Astrophysics Data System (ADS)

    Forcucci, Stephen J.

    2014-07-01

    Nitinol medical device implants made from a laser cut tubing process (i.e., stents, valve structures, etc.) frequently require a fatigue durability assessment, which necessitates determining the material fatigue properties. Towards the goal of determining the strain-based endurance limit of medical grade superelastic Nitinol tubing, a coupon was designed and evaluated via FEA using Abaqus software, produced via laser cutting, shape setting, and electro-polishing processes, and then fatigue tested to 10 million cycles. FEA was used to determine the strain versus alternating displacement amplitude for the coupon. Error due to dimensional tolerances was determined. The coupons were then fatigue tested in a 37 °C temperature deionized water bath at alternating strain levels ranging from 0.75 to 4.0% at zero mean strain. Sample replication was greater than 90%, and the median alternating strain fatigue limit was determined via two methods. Confidence and reliability with maximum likelihood statistics are used to present a strain-based endurance limit for the material. The results seem to differ from previous published values.

  9. Bilateral Renal Artery Aneurysm: Percutaneous Treatment with Stent-Graft Placement

    SciTech Connect

    Gandini, R.; Spinelli, A.; Pampana, E.; Fabiano, S.; Pendenza, G. Simonetti, G.

    2006-10-15

    A 51-year-old man with an 8-year history of hypertension (170/115 mmHg with two drugs) and altered renal function (5.6 mg/dl serum creatinine, 101 mg/dl BUN) was referred to our Department to evaluate the renal arteries and rule out renovascular hypertension. Doppler ultrasound and magnetic resonance angiography revealed significant bilateral renal artery stenosis and the presence of bilateral renal artery aneurysms. A self-expandable polytetrafluoroethylene (PTFE)-covered nitinol stent-graft was deployed in each renal artery to treat the stenoses and to exclude the aneurysm. Postprocedural digital subtraction angiography confirmed the resolution of the renal artery stenoses and the complete exclusion of the aneurysms. At the 6 month follow-up, color Doppler confirmed normal patency of the renal arteries with complete exclusion of the aneurysms and significant reduction of the blood pressure (130/85 mmHg with one drug) and serum creatinine levels (2.1 mg/dl)

  10. Stenting of the Upper Gastrointestinal Tract: Current Status

    SciTech Connect

    Katsanos, Konstantinos; Sabharwal, Tarun Adam, Andreas

    2010-08-15

    Minimally invasive image-guided insertion of self-expanding metal stents in the upper gastrointestinal tract is the current treatment of choice for palliation of malignant esophageal or gastroduodenal outlet obstructions. A concise review is presented of contemporary stenting practice of the upper gastrointestinal tract, and the procedures in terms of appropriate patient evaluation, indications, and contraindications for treatment are analyzed, along with available stent designs, procedural steps, clinical outcomes, inadvertent complications, and future technology. Latest developments include biodegradable polymeric stents for benign disease and radioactive or drug-eluting stents for malignant obstructions.

  11. Passivation of nitinol wire for vascular implants--a demonstration of the benefits.

    PubMed

    O'Brien, B; Carroll, W M; Kelly, M J

    2002-04-01

    This study investigated a passivation process for polished nitinol wires and vascular stent components, after being given a typical shape setting heat treatment. Heat treated samples were passivated in a nitric acid solution and a series of corrosion tests, surface analysis and chemical analysis was performed. Potentiodynamic polarization tests demonstrated a significant increase in breakdown potential for passivated samples, compared to heat treated surfaces. Surface analysis indicated that the passivation reduces Ni and NiO content in the oxide and increases TiO2 content. Chemical analysis of passivation solutions suggests that the improvement in corrosion resistance is proportional to the quantity of nickel removed. Long term immersion tests demonstrate that nickel release from the surface of the material decreases with time and the quantity of nickel released is lower for passivated samples. The improved corrosion resistance is maintained after extended periods of immersion in saline solution.

  12. Educational Pathways through Nanoscience: Nitinol as a Paradigmatic Smart Material

    ERIC Educational Resources Information Center

    Lisotti, Annamaria; De Renzi, Valentina; Rozzi, Carlo Andrea; Villa, Elena; Albertini, Franca; Goldoni, Guido

    2013-01-01

    We developed an educational path based on nitinol, a shape memory alloy which conveniently exemplifies the smart material concept, i.e., a material that performs a predetermined, reversible action in response to a change in the environment. Nitinol recovers a given shape, changes its resistivity drastically and modifies its elastic properties if…

  13. Residual stresses in coronary artery stents.

    PubMed

    Möller, D; Reimers, W; Pyzalla, A; Fischer, A

    2001-01-01

    In western industrial countries, coronary heart disease is the most common cause of death. The reason is a coronary sclerosis, which by the generation of plaques narrows the inner lumen of an artery and, thus, deteriorates the blood supply. This leads to symptoms like burning pain or increased pressure in the chest, and finally to an under supply and damage of the heart muscle. In order to keep those portions of arteries that are covered by a plaque open, the stent technique was developed in the 1980s and is increasingly used since about 13 years. These stents are usually made of wires or of a slotted tube and are of two kinds: self-expanding and balloon expanding. Both types are implanted after being mounted on a catheter and expanded in the desired position. Self-expanding stents make use of the elastic deformation, while the other group of stents are expanded by a balloon, which brings about a plastic deformation of certain regions of the stent structure. Thus, after implantation, parts of these stents undergo two steps of distinct plastic deformation. First during compression, which is necessary for the mounting procedure on the catheter (crimping), and second during expansion for implantation. In this article, the residual stresses generated during crimping and expansion are presented and discussed. These stresses are stored in the structure of a portion of a stent after implantation and are superimposed on those stresses generated by the more than 700 million cyclic heart beats during the patient's life. This work is a part of several interdisciplinary research projects by the authors in order to gain reliable fail-safe criteria for the static and cyclic mechanical properties of coronary stents.

  14. Nitinol 60 as a Material For Spacecraft Triboelements

    NASA Technical Reports Server (NTRS)

    Pepper, Stephen V.; DellaCorte, Christopher; Noebe, Ronald D.; Hall, David R.; Glennon, Glenn

    2009-01-01

    The mechanical properties of Nitinol 60, 60 w/o Ni, 40 w/oTi (55 a/o Ni, 45 a/o Ti) are sufficiently attractive to warrant its consideration as a lubricated spacecraft triboelement. The ability to lubricate Nitinol 60 by the oils usually used on spacecraft mechanisms--Pennzane 2001A, Krytox 143AC and Castrol 815Z - was experimentally determined. These oils were run in the boundary lubrication regime for Nitinol 60 balls running against a 440C steel counterface in the vacuum spiral orbit tribometer. Test results consisting of the coefficient of friction versus time (friction traces) and relative degradation rates are presented. Contrary to the inability to successfully lubricate other metal alloys with high titanium content, it was found that Nitinol 60 is able to be lubricated by these oils. Overall, the results presented here indicate that Nitinol 60 is a credible candidate material for spacecraft bearing applications.

  15. Angioplasty and Vascular Stenting

    MedlinePlus

    ... Drug-coated (also called drug-eluting) stents have recently been approved for clinical use by the U.S. ... you notify the MRI department that you have recently had a stent. Although stents used today may ...

  16. Auxetic oesophageal stents: structure and mechanical properties.

    PubMed

    Ali, Murtaza Najabat; Busfield, James J C; Rehman, Ihtesham U

    2014-02-01

    values where the Auxetic stent fails. Finite element models of both Auxetic film and Auxetic stent were developed, and the results were compared with experimental results with a good agreement. The tensile testing of the Auxetic polyurethane films revealed that the Poisson's ratio of the sample ranged between -0.87 and -0.963 at different uniaxial tensile load values. From the stent expansion test, it was found that the Auxetic oesophageal stent radially expanded from 0.5 to 5.73 mm and longitudinally extended from 0.15 to 1.83 mm at a range of applied pressure increments (0.5-2.7 bar) from the balloon catheter.

  17. Symptomatic stent cast.

    PubMed

    Keohane, John; Moore, Michael; O'Mahony, Seamus; Crosbie, Orla

    2008-02-01

    Biliary stent occlusion is a major complication of endoscopic stent insertion and results in repeat procedures. Various theories as to the etiology have been proposed, the most frequently studied is the attachment of gram negative bacteria within the stent. Several studies have shown prolongation of stent patency with antibiotic prophylaxis. We report the case of stent occlusion from a cast of a previously inserted straight biliary stent; a "stent cast" in an 86-year-old woman with obstructive jaundice. This was retrieved with the lithotrypter and she made an uneventful recovery. This is the first reported case of a biliary stent cast.

  18. Gastroesophageal stenting for the management of post sleeve gastrectomy leak

    PubMed Central

    Guzaiz, Noha; Arabi, Mohammad; Khankan, Azzam; Salman, Refaat; Al-Toki, Mohammed; Qazi, Shahbaz; Alzakari, Abdulmohsin; Al-Moaiqel, Mohammad

    2016-01-01

    Objectives To retrospectively evaluate the effectiveness of gastroesophageal stenting for post sleeve gastrectomy staple line leaks using removable self-expandable stents. Methods Between April 2012 and June 2015, 12 consecutive patients (6 males) with mean age of 34 years: (21-38 years) presented with staple line leak 1-8 weeks after the operation (mean 2.8 weeks). Patients underwent gastroesophageal stenting by interventional radiology. A total of 23 stents were deployed with mean length of 17.8 cm (7-24 cm) and mean diameter 25.6 mm (18-36 mm). Stent re-insertion was needed in 7 patients (9 procedure), while 6 patients required percutaneous collection drainage and 3 patients required endoscopic glue injection with clipping. Two stent removal procedures were carried out under endoscopic visualization after failed stent capture under fluoroscopy, while the remaining stents were successfully removed by interventional radiology. Results Stent placement was technically successful in all patients. Stent migration occurred in 6 patients (50%). There is a tendency for stent migration with shorter stent length (R= -0.557, p=0.008). The mean duration of stenting was 60.5 days (14-137 days). All patients underwent stent removal and resumed oral intake with no recurrence of leak at a mean follow up time of 190 days (14-410 days). Complications included gastrointestinal bleeding (n=1), proximal esophageal stricture (n=1) and stent occlusion (n=1). Conclusion Gastroesophageal stenting as a primary measure after diagnosis of early post sleeve gastrectomy leak appears to offer a safe and effective alternative option in obviating repeat surgical interventions. Minimally invasive interventions may still be required for the management of persistent leak. PMID:27874149

  19. Long-Term Histopathologic and IVUS Evaluations of a Novel Coiled Sheet Stent in Porcine Carotid Arteries

    SciTech Connect

    Kaneda, Hideaki; Ikeno, Fumiaki Lyons, Jennifer; Rezaee, Mehrdad; Yeung, Alan C.; Fitzgerald, Peter J.

    2006-06-15

    Carotid angioplasty with stent placement has been proposed as an alternative method for revascularization of carotid artery stenosis. A novel stent with a laser-cut, rolled sheet of Nitinol (EndoTex Interventional Systems, Inc., Cupertino, CA) has been developed to customize treatment of stenotic lesions in carotid arteries utilizing a single stent, designed to adapt to multiple diameters and to tapered or nontapered configurations. The purpose of this study is to evaluate the conformability and vascular response to a novel stent in a chronic porcine carotid model using serial three-dimensional intravascular ultrasound (IVUS) analysis as well as histological examination. Ten Yucatan pigs underwent stent implantation in both normal carotid arteries with adjunctive balloon angioplasty. Three-dimensional IVUS analysis was performed before stent implantation, after adjunctive balloon angioplasty, and at follow-up [1 month (n = 6), 3 months (n = 6), or 6 months (n = 8)]. Histological examination (injury score, percent plaque obstruction, and qualitative analysis) was also performed. All stents were successfully deployed and well apposed in different sized vessels (lumen area range: 19-30 mm{sup 2}). Volumetric IVUS analysis showed no significant difference between the lumen areas before stent implantation and after adjunctive balloon angioplasty and no stent area change at each follow-up point compared to immediately postprocedure. Histological examination revealed minimal injury and neointimal hyperplasia at each follow-up point. In the chronic porcine carotid model, the novel stent system demonstrated good conformability, resulting in minimal vessel injury and neointimal formation.

  20. Evaluation of Angiographic and Technical Aspects of Carotid Stenting with Diffusion-Weighted Magnetic Resonance Imaging

    SciTech Connect

    Blasel, Stella Hattingen, Elke; Berkefeld, Joachim; Kurre, Wiebke; Morawe, Gerald; Zanella, Friedhelm; Rochemont, Richard Du Mesnil de

    2009-07-15

    The detection of clinically silent ischemic lesions on postprocedural diffusion-weighted magnetic resonance images has become a preferred method for the description of embolic risks. The purpose of this single-center study was to evaluate whether diffusion-weighted imaging (DWI) could determine material related or technical risk factors of filter-protected carotid stenting. Eighty-four patients with symptomatic severe ({>=}60%) carotid artery stenoses received filter-protected carotid stenting. Standard DWI (b = 1000) was performed within 48 h before and after carotid stenting. The occurrence and load of new postinterventional DWI lesions were assessed. Multivariate analysis was performed to determine risk factors associated with DWI lesions, with emphasis on technical factors such as use of different access devices (guiding catheter method vs. long carotid sheath method), type of stent (open-cell nitinol stent vs. closed-cell Wallstent), and protective device (filters with 80-{mu}m vs. 110-120-{mu}m pore size). Markers for generalized atherosclerosis and for degree and site of stenosis were assessed to allow comparison of adequate risk profiles. Access, protective device, and stent type were not significantly associated with new embolic DWI lesions when we compared patients with equivalent risk profiles (long carotid sheath method 48% [11 of 23] vs. guiding catheter method 44% [27 of 61], Wallstent 47% [15 of 32] vs. nitinol stent 44% [23 of 52], and small pore size filter 61% [11 of 18] vs. large pore size filter 41% [27 of 66]). Single-center DWI studies with a moderate number of cases are inadequate for proper assessment of the embolic risk of technical- or material-related risk factors in carotid stenting. Larger multicenter studies with more cases are needed.

  1. Role of stents and laser therapy in biliary strictures

    NASA Astrophysics Data System (ADS)

    Chennupati, Raja S.; Trowers, Eugene A.

    2001-05-01

    The most frequent primary cancers causing malignant obstructive jaundice were pancreatic cancer (57%), hilar biliary cancer (19% including metastatic disease), nonhilar biliary cancer (14%) and papillary cancer (10%). Endoscopic stenting has widely replaced palliative surgery for malignant biliary obstruction because of its lower risk and cost. Self-expandable metal stents are the preferred mode of palliation for hilar malignancies. Plastic stents have a major role in benign biliary strictures. Major complications and disadvantages associated with metallic stents include high cost, cholangitis. malposition, migration, unextractability, and breakage of the stents, pancreatitis and stent dysfunction. Dysfunction due to tumor ingrowth can be relieved by thermal methods (argon plasma coagulator therapy). We present a concise review of the efficacy of metallic stents for palliation of malignant strictures.

  2. A novel biodegradable esophageal stent: results from mechanical and animal experiments.

    PubMed

    Liu, Jin; Shang, Liang; Liu, Jiyong; Qin, Chengyong

    2016-01-01

    Biodegradable esophageal stents eliminate stent retrieval, but usually induce hyperplasia. This study investigated the properties of a novel biodegradable stent in vitro and in vivo. The degradation of the novel stent was observed in phosphate buffered saline (PBS) for 8 weeks. The radial forces, pH values, morphology, and retention rate of the intrinsic viscosity (R[η]) of the new biodegradable stent were all evaluated. In vitro, the pH values remained constant for 4 weeks and declined from weeks 4 to 8. The biodegradable threads degraded and ruptured at 6 weeks. Consequently, the radial force of the stent decreased to zero at that time. The curve of R[η] decreased with time linearly in PBS. To study the stents in vivo, we used a stricture model in which the middle esophagus of rabbits was damaged by alkali burn. Stents were inserted 2 weeks after injury and observed for 8 weeks. We assessed complications related to stent insertion, degradation of the stent, and survival of the rabbits. Two stents migrated, and one rabbit died. In the other rabbits, two stents degraded and moved into the stomach during the sixth week, five during the seventh week and one during the eighth week, respectively. One stent remained in position until the end of the study. In conclusion, our newly designed stent retained the strong radial force of self-expandable metal stents (SEMSs) and maintained the biodegradable properties of biodegradable (BD) stents.

  3. A novel electrical potential sensing method for in vitro stent fracture monitoring and detection.

    PubMed

    Park, Chan-Hee; Tijing, Leonard D; Yun, Yeoheung; Kim, Cheol Sang

    2011-01-01

    This article describes a preliminary investigation and prototype fabrication of a novel potential sensing method to continuously monitor vascular stent fractures. A potential measurement system consisting of Wheatstone bridge circuit and signal conditioning circuit was designed for the cardiovascular stent durability and fatigue test. Each end of a bare and polyurethane-covered Nitinol vascular stent was electrically connected to the potential measurement system and then immersed either in simulated body fluid (SBF) media or distilled water at 36.4 ± 1 °C. When the stent experienced fracture (i.e., a cut), its electrical potential decreased with an increase in electrical resistance. This method successfully measured fractures in the stent regardless of location. Furthermore, the number of cycles at the onset of stent fracture was accurately detected and continuously monitored using this technique. Thus, the present fracture detection method, which to our knowledge is the first ever report to use electrical potential measurement for stent durability test, gives a fast, real-time, accurate and efficient detection of fractures in stent during in vitro fatigue and durability test.

  4. Colorectal Stents: Current Status

    PubMed Central

    Lee, Jeong-Mi

    2015-01-01

    A self-expandable metal stent (SEMS) is an effective and safe method for the decompression of colon obstruction. Based on recent evidence, colorectal SEMS is now recommended for the palliation of patients with colonic obstruction from incurable colorectal cancer or extracolonic malignancy and also as a bridge to surgery in those who are a high surgical risk. Prophylactic SEMS insertion in patients with no obstruction symptoms is not recommended. Most colorectal SEMS are inserted endoscopically under fluoroscopic guidance. The technical and clinical success rates of colorectal SEMS are high, and the complication rate is acceptable. Advances in this technology will make the insertion of colorectal SEMS better and may expand the indications of colorectal SEMS in the future. PMID:26064818

  5. Experimental Study of Blood Laminar Flow Through a Stented Artery

    DTIC Science & Technology

    2001-10-25

    stenosis in coronary arteries. Since the 80’s, there is an alternative to the usual balloon angioplasty . Indeed, the use of tiny metallic scaffolds (named...following one: the coronary stent is placed over the angioplasty balloon and moved to the site of lesion. The stent expands with the balloon and remains...values. The coronary angioplasty is responsible of wall shear stress modification, mainly between the stent struts, at the inlet and the outlet of

  6. Influence of Microstructure on the Performance of Nitinol: A Computational Analysis

    NASA Astrophysics Data System (ADS)

    Weafer, F. M.; Bruzzi, M. S.

    2014-07-01

    One material that has found particular favor for use in biomedical endovascular stents is the near equi-atomic NiTi alloy, Nitinol. One remarkable trait exhibited by this superelastic material is the improvement of its fatigue performance with increasing mean strain (Ref 1, 2). Clarification into this phenomenon still remains incomplete in the literature. This study proposes a microstructural explanation for this unique macroscopic behavior; it is hypothesized stress-induced martensite (SIM) will stabilize with increasing strain which, in turn, leads to the observed increase in fatigue life. Finite element analysis (FEA) is employed to investigate the behavior of a "v-strut" stent subcomponent under various strain levels. The volume fraction of SIM is analyzed to identify its potential influence on macroscopic response and, ultimately, fatigue behavior. In addition, a computational investigation is performed on the effect of crystallographic texture on macroscopic response. Granular transformational behavior is analyzed using FEA models with realistic and idealized grain structures, specifically evaluating the effect of individual grain orientations on the stress-induced martensite transformation.

  7. Fast Virtual Stenting with Active Contour Models in Intracranical Aneurysm

    PubMed Central

    Zhong, Jingru; Long, Yunling; Yan, Huagang; Meng, Qianqian; Zhao, Jing; Zhang, Ying; Yang, Xinjian; Li, Haiyun

    2016-01-01

    Intracranial stents are becoming increasingly a useful option in the treatment of intracranial aneurysms (IAs). Image simulation of the releasing stent configuration together with computational fluid dynamics (CFD) simulation prior to intervention will help surgeons optimize intervention scheme. This paper proposed a fast virtual stenting of IAs based on active contour model (ACM) which was able to virtually release stents within any patient-specific shaped vessel and aneurysm models built on real medical image data. In this method, an initial stent mesh was generated along the centerline of the parent artery without the need for registration between the stent contour and the vessel. Additionally, the diameter of the initial stent volumetric mesh was set to the maximum inscribed sphere diameter of the parent artery to improve the stenting accuracy and save computational cost. At last, a novel criterion for terminating virtual stent expanding that was based on the collision detection of the axis aligned bounding boxes was applied, making the stent expansion free of edge effect. The experiment results of the virtual stenting and the corresponding CFD simulations exhibited the efficacy and accuracy of the ACM based method, which are valuable to intervention scheme selection and therapy plan confirmation. PMID:26876026

  8. Elastic recoil of coronary stents: a comparative analysis.

    PubMed

    Barragan, P; Rieu, R; Garitey, V; Roquebert, P O; Sainsous, J; Silvestri, M; Bayet, G

    2000-05-01

    Minimum elastic recoil (ER) has became an essential feature of new coronary stents when deployed in artheromatous lesions of various morphologies. The ER of coronary stent might be an important component of 6-month restenosis rate by minimizing the luminal loss. We evaluated the intrinsic ER of 23 coronary stents with a mechanical test bench. The amount of ER for one size of stent (3.0 mm) was quantified using a 3D optical contactless machine (Smartscope MVP, Rochester, NY). The stents were expanded on their own balloon for the precrimped stents; the uncrimped stents were expended using identical 3.0-mm balloons. Two types of measurements were done without exterior stress and with a 0.2-bar exterior stress, directly on the stent at the end of balloon expansion, immediately after balloon deflation, and then 30 min, 60 min, and 120 min after. ER ranged from 1.54%+/-0.81% (Bestent BES 15) to 16.51%+/-2.89% (Paragon stent) without stress (P<0.01) and from 2.35%+/-1.14% (Bestent BES 15) to 18.34%+/-2.41% (Cook GR2) under 0.2-bar pressure (P<0.0001). Furthermore, there was a significant reduction between the mean result of tubular stents (TS) and coil stents (CS). The results of in vitro mechanical tests may confirm strongly the interest of a minimum ER in the prevention of the 6-month restenosis.

  9. Nitinol for Prosthetic and Orthotic Applications

    NASA Astrophysics Data System (ADS)

    Henderson, Emma; Buis, Arjan

    2011-07-01

    As global populations age, conditions such as stroke and diabetes require individuals to use rehabilitation technology for many years to come due to chronic musculoskeletal, sensory, and other physical impairments. One in four males currently aged 45 will experience a stroke within 40 years and will often require access to prolonged rehabilitation. In addition, worldwide, one individual loses a limb every 30 s due to the complications of diabetes. As a result, innovative ideas are required to devise more effective prosthetic and orthotic devices to enhance quality of life. While Nitinol has already found much favor within the biomedical industry, one area, which has not yet exploited its unique properties, is in the field of physical rehabilitation, ranging from prosthetic and orthotic devices to assistive technology such as wheelchairs. Improved intervention capabilities based on materials such as Nitinol have the potential to vastly improve patients' quality of life and in the case of orthoses, may even reduce the severity of the condition over time. It is hoped that this study will spark discussion and interest for the materials community in a field which has yet to be fully exploited.

  10. Surface modifications of Nitinol for biomedical applications.

    PubMed

    Sun, F; Sask, K N; Brash, J L; Zhitomirsky, I

    2008-11-15

    Cathodic electrophoretic deposition (EPD) has been utilized for the fabrication of composite films for the surface modification of NiTi shape memory alloys (Nitinol). In the proposed method, chitosan (CH) was used as a matrix for the incorporation of other functional materials, such as heparin, hydroxyapatite and bioglass. Chitosan-heparin films were deposited from solutions of non-stoichiometric chitosan-heparin complexes. It was found that the addition of anionic heparin to the solutions of cationic chitosan resulted in a significant increase in the cathodic deposition rate. The thickness of the films prepared by this method varied in the range of 0.1-3 microm. The ability of the chitosan-heparin films to bind antithrombin, as measured by binding of (125)I-radiolabeled antithrombin, was much greater than that of pure chitosan films. Composite chitosan-hydroxyapatite films, with thickness of 1-30 microm, were obtained as monolayers or laminates, containing chitosan-hydroxyapatite layers, separated by layers of pure chitosan. The hydroxyapatite nanoparticles showed preferred orientation in the chitosan matrix with the c-axis parallel to the substrate surface. The films showed corrosion protection of the Nitinol substrates in Ringer's physiological solutions. The feasibility of the fabrication of composite films containing hydroxyapatite and bioglass in the chitosan matrix has been demonstrated. The method offers the advantages of room temperature processing. The deposition mechanisms and possible applications of the films are discussed.

  11. Palliation of Pyloric Stenosis Caused by Gastric Cancer Using an Endoscopically Placed Covered Ultraflex Stent: Covered Stent Inside an Occluded Uncovered Stent

    SciTech Connect

    Nakamura, Toshifumi; Kitagawa, Mutsuo; Takehira, Yasunori; Yamada, Masami; Nishiwaki, Yoshiro; Nakamura, Hirotoshi

    2000-07-15

    A 71-year-old man developed pyloric stenosis caused by gastric cancer. Vomiting and nausea resolved after the insertion of an uncovered Ultraflex stent (length 10 cm, inner diameter 18u23 mm) through a 7-cm-long stenosis, and the patient was able to eat a soft diet. After 6 weeks, stent occlusion occurred due to tumor ingrowth and accumulation of food residue. Endoscopic observation showed a very narrow residual lumen. A covered Ultraflex stent (length 10 cm, inner diameter 18u23 mm) was inserted through the first stent and expanded to its maximum diameter over the next 2 days. The patient's vomiting and nausea improved rapidly. He died 6 months after the second stenting procedure, from metastatic tumor spread, having remained free of nausea and vomiting. In this case, a covered metallic stent prevented tumor ingrowth and maintained gastrointestinal patency.

  12. Selection and fabrication of a non-woven polycarbonate urethane cover for a tissue engineered airway stent.

    PubMed

    Chen, Weiluan; Clauser, Johanna; Thiebes, Anja Lena; McGrath, Donnacha J; McHugh, Peter E; Steinseifer, Ulrich; Jockenhoevel, Stefan; Hennink, Wim E; Kok, Robbert Jan

    2016-11-30

    One of the major problems in end-stage bronchotracheal cancer is stenosis of the upper airways, either due to luminal ingrowth of the tumor or mucus plugging. Airway stents that suppress tumor ingrowth and sustain mucociliary transport can alleviate these problems in end-stage bronchial cancer. We evaluated different types of polymeric covers for a tissue engineered airway stent. The distinguishing feature of this stent concept is that respiratory epithelial cells can grow on the luminal surface of the stent which facilitates mucociliary clearance. To facilitate growth of epithelial cells at the air-liquid interface of the stent, we developed a polyurethane cover that allows transport of nutrients to the cells. Nonwoven polycarbonate urethane (PCU) covers were prepared by a spraying process and evaluated for their porosity and glucose permeability. Respiratory epithelial cells harvested from sheep trachea were cultured onto the selected PCU cover and remained viable at the air-liquid interface when cultured for 21days. Lastly, we evaluated the radial force of a PCU-covered nitinol stent, and showed the PCU covers did not adversely affect the mechanical properties of the stents for their intended application in the smaller bronchi. These in vitro data corroborate the design of a novel airway stent for palliative treatment of bronchotracheal stenosis by combination of stent-technology with tissue-engineered epithelial cells.

  13. Esophagojejunal Anastomosis Fistula, Distal Esophageal Stenosis, and Metalic Stent Migration after Total Gastrectomy

    PubMed Central

    Al Hajjar, Nadim; Popa, Calin; Al-Momani, Tareg; Margarit, Simona; Graur, Florin; Tantau, Marcel

    2015-01-01

    Esophagojejunal anastomosis fistula is the main complication after a total gastrectomy. To avoid a complex procedure on friable inflamed perianastomotic tissues, a coated self-expandable stent is mounted at the site of the anastomotic leak. A complication of stenting procedure is that it might lead to distal esophageal stenosis. However, another frequently encountered complication of stenting is stent migration, which is treated nonsurgically. When the migrated stent creates life threatening complications, surgical removal is indicated. We present a case of a 67-year-old male patient who was treated at our facility for a gastric adenocarcinoma which developed, postoperatively, an esophagojejunostomy fistula, a distal esophageal stenosis, and a metallic coated self-expandable stent migration. To our knowledge, this is the first reported case of an esophagojejunostomy fistula combined with a distal esophageal stenosis as well as with a metallic coated self-expandable stent migration. PMID:25945277

  14. Esophagojejunal anastomosis fistula, distal esophageal stenosis, and metalic stent migration after total gastrectomy.

    PubMed

    Al Hajjar, Nadim; Popa, Calin; Al-Momani, Tareg; Margarit, Simona; Graur, Florin; Tantau, Marcel

    2015-01-01

    Esophagojejunal anastomosis fistula is the main complication after a total gastrectomy. To avoid a complex procedure on friable inflamed perianastomotic tissues, a coated self-expandable stent is mounted at the site of the anastomotic leak. A complication of stenting procedure is that it might lead to distal esophageal stenosis. However, another frequently encountered complication of stenting is stent migration, which is treated nonsurgically. When the migrated stent creates life threatening complications, surgical removal is indicated. We present a case of a 67-year-old male patient who was treated at our facility for a gastric adenocarcinoma which developed, postoperatively, an esophagojejunostomy fistula, a distal esophageal stenosis, and a metallic coated self-expandable stent migration. To our knowledge, this is the first reported case of an esophagojejunostomy fistula combined with a distal esophageal stenosis as well as with a metallic coated self-expandable stent migration.

  15. Mode of deployment of coronary Palmaz-Schatz stents after implantation with the stent delivery system: an intravascular ultrasound study.

    PubMed

    Kiemeneij, F; Laarman, G; Slagboom, T

    1995-04-01

    The stent delivery system (SDS) is a sheath-covered Palmaz-Schatz stent mounted on a 3.0, 3.5, or 4.0 mm compliant polyethylene balloon catheter; the balloon resists maximal inflation pressures of 5.7, 6.2, or 6.0 atm, respectively. It is postulated that these pressures are too low to obtain optimal stent deployment. Because optimal stent deployment is a prerequisite for optimal short- and long-term outcome, we performed an intravascular ultrasound study to the mode of stent deployment after delivery with the SDS and after high-pressure dilatations with low-compliant, oversized balloon catheters. In 23 patients an intravascular ultrasound study (30 MHz, 4.3F transducer) was performed to the geometry of 29 stents immediately after delivery with the SDS and after successive high-pressure inflations with low-compliant balloons. After delivery with the SDS (3.3 +/- 0.4 mm), stent diameter was 3.0 +/- 0.4 mm. After high-pressure dilatations (12.4 +/- 1.4 atm) with low-compliant balloons (3.9 +/- 0.5 mm), stent diameter increased to 3.4 +/- 0.4 mm (p < 0.001). Only 8 (28%) stents were completely and symmetrically expanded to the corresponding reference diameter with good apposition after delivery with the SDS. Diameter of incomplete deployed stents (n = 16) was 2.8 +/- 0.3 mm. After high-pressure dilatations with low-compliant balloons (3.9 +/- 0.5 mm), diameter increased to 3.4 +/- 0.4 mm (p < 0.001). Now 20 (69%) stents (p = 0.004) became completely and symmetrically expanded to a diameter corresponding to the reference diameter. In conclusion, most stents are suboptimally deployed after delivery with the stent delivery system.(ABSTRACT TRUNCATED AT 250 WORDS)

  16. Effects of plaque lengths on stent surface roughness.

    PubMed

    Syaifudin, Achmad; Takeda, Ryo; Sasaki, Katsuhiko

    2015-01-01

    The physical properties of the stent surface influence the effectiveness of vascular disease treatment after stent deployment. During the expanding process, the stent acquires high-level deformation that could alter either its microstructure or the magnitude of surface roughness. This paper constructed a finite element simulation to observe the changes in surface roughness during the stenting process. Structural transient dynamic analysis was performed using ANSYS, to identify the deformation after the stent is placed in a blood vessel. Two types of bare metal stents are studied: a Palmaz type and a Sinusoidal type. The relationship between plaque length and the changes in surface roughness was investigated by utilizing three different length of plaque; plaque length longer than the stent, shorter than the stent and the same length as the stent. In order to reduce computational time, 3D cyclical and translational symmetry was implemented into the FE model. The material models used was defined as a multilinear isotropic for stent and hyperelastic for the balloon, plaque and vessel wall. The correlation between the plastic deformation and the changes in surface roughness was obtained by intermittent pure tensile test using specimen whose chemical composition was similar to that of actual stent material. As the plastic strain is achieved from FE simulation, the surface roughness can be assessed thoroughly. The study found that the plaque size relative to stent length significantly influenced the critical changes in surface roughness. It was found that the length of stent which is equal to the plaque length was preferable due to the fact that it generated only moderate change in surface roughness. This effect was less influential to the Sinusoidal stent.

  17. Prophylactic stenting for esophageal stricture prevention after endoscopic submucosal dissection

    PubMed Central

    Shi, Ke-Da; Ji, Feng

    2017-01-01

    Endoscopic submucosal dissection (ESD) of superficial esophageal cancer has been increasingly used as an alternative to surgery because it is minimally invasive and has a high rate of en bloc resection. However, a high rate of esophageal stricture is observed after ESD for large lesions, which can dramatically decrease the patient’s quality of life. Stricture prevention is necessary to allow for endoscopic therapy to expand. We, herein, review the most recent evidence and discuss the role of the metallic self-expandable stent and the biodegradable stent in esophageal stricture prevention. Limited studies suggested that prophylactic stenting could reduce the stricture rate without increasing the number of complications. In addition, the number of bougie dilation procedures was significantly lower with stent placement. Esophageal stenting is a promising option for post-ESD stricture prevention. However, current evidence is too preliminary to formulate practice standards. Future studies are needed to further validate the efficacy and safety of prophylactic stenting and determine the best strategy for stricture prevention. Stent migration is the most common complication. A new stent that has advantages of a low migration rate and minimal tissue reaction will need to be developed. Therefore, randomized controlled trials with long-term follow-up periods are required before prophylactic stenting could be considered a valid option to prevent post-ESD stricture. PMID:28246466

  18. Hot Isostatic Pressing of 60-Nitinol

    NASA Technical Reports Server (NTRS)

    Stanford, Malcolm K.

    2015-01-01

    The effects of varying the time, temperature and pressure during consolidation of 60-Nitinol (Nickel Titanium alloy) by hot isostatic pressing (HIP) were examined. Six HIP cycles with a cycle time of either 2 or 20 hours, temperature of 900 or 1000 degrees Centigrade, and a chamber pressure of either 100 or 200 millipascals were used. The cycle representing the shortest cycle time at the highest temperature and pressure (2 hours/1000 degrees Centigrade/200 millipascals) produced material with the highest hardness (720 Vickers Pyramid Number (HV)). A modest increase in average grain size and significant porosity reduction were observed in material subjected to the longest cycle time at the highest temperature, regardless of the pressure applied. The intent of this study is to facilitate the technology transfer involved in the processing of this material.

  19. Double-layered covered stent for the treatment of malignant oesophageal obstructions: Systematic review and meta-analysis

    PubMed Central

    Hussain, Zeiad; Diamantopoulos, Athanasios; Krokidis, Miltiadis; Katsanos, Konstantinos

    2016-01-01

    AIM To investigate the efficacy of double-layered covered stent in the treatment of malignant oesophageal obstructions. METHODS A systematic review and meta-analysis was performed following the PRISMA process. PubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus and online content, were searched for studies reporting on the NiTi-S polyurethane-covered double oesophageal stent for the treatment of malignant dysphagia. Weighted pooled outcomes were synthesized with a random effects model to account for clinical heterogeneity. All studies reporting the outcome of palliative management of dysphagia due to histologically confirmed malignant oesophageal obstruction using double-layered covered nitinol stent were included. The level of statistical significance was set at α = 0.05. RESULTS Six clinical studies comprising 250 patients in total were identified. Pooled technical success of stent insertion was 97.2% (95%CI: 94.8%-98.9%; I2 = 5.8%). Pooled complication rate was 27.6% (95%CI: 20.7%-35.2%; I2 = 41.9%). Weighted improvement of dysphagia on a scale of 0-5 scoring system was -2.00 [95%CI: -2.29%-(-1.72%); I2 = 87%]. Distal stent migration was documented in 10 out of the 250 cases examined. Pooled stent migration rate was 4.7% (95%CI: 2.5%-7.7%; I2 = 0%). Finally, tumour overgrowth was reported in 34 out of the 250 cases with pooled rate of tumour overgrowth of 11.2% (95%CI: 3.7%-22.1%; I2 = 82.2%). No funnel plot asymmetry to suggest publication bias (bias = 0.39, P = 0.78). In the sensitivity analysis all results were largely similar between the fixed and random effects models. CONCLUSION The double-layered nitinol stent provides immediate relief of malignant dysphagia with low rates of stent migration and tumour overgrowth PMID:27678367

  20. Galvanic corrosion of nitinol under deaerated and aerated conditions.

    PubMed

    Pound, Bruce G

    2016-10-01

    Various studies have examined the corrosion rate of nitinol generally under deaerated conditions. Likewise, galvanic corrosion studies have typically involved deaerated solutions. This work addressed the effect of galvanic coupling on the corrosion current of electropolished nitinol in phosphate buffered saline and 0.9% sodium chloride under dearated and aerated conditions for times up to 24 h. Tests were performed on nitinol alone and coupled with MP35N in both the mechanically polished and passivated conditions. Aeration and galvanic coupling were found to have relatively little effect, indicating that the corrosion current is controlled by the anodic reaction. The current can be attributed entirely to Ni(2+) dissolution, which appears to be governed by solid-state mass transport of Ni(2+) through the passive oxide film. Because corrosion of EP nitinol is controlled by the anodic reaction, contact between EP nitinol and MP35N or other biomedical Co-Cr alloys is unlikely to result in significant galvanic effects in vivo. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1322-1327, 2016.

  1. Nitinol: Tubing versus sputtered film - microcleanliness and corrosion behavior.

    PubMed

    Wohlschlögel, Markus; Lima de Miranda, Rodrigo; Schüßler, Andreas; Quandt, Eckhard

    2016-08-01

    Corrosion behavior and microcleanliness of medical-device grade Nitinol tubing (Nix Ti1- x , x = 0.51; outer diameter 7 mm, wall thickness 0.5 mm), drawn from various ingot qualities, are compared to the characteristics of sputtered Nitinol film material (Nix Ti1- x , x = 0.51; thickness 50 µm). Electropolished tubing half-shell samples are tested versus as-received sputtered film samples. Inclusion size distributions are assessed using quantitative metallography and corrosion behavior is investigated by potentiodynamic polarization testing in phosphate-buffered saline at body temperature. For the sputtered film samples, the surface chemistry is additionally analyzed employing Auger Electron Spectroscopy (AES) composition-depth profiling. Results show that the fraction of breakdowns in the potentiodynamic polarization test correlates with number and size of the inclusions in the material. For the sputtered Nitinol film material no inclusions were detectable by light microscopy on the one hand and no breakdowns were found in the potentiodynamic polarization test on the other hand. As for electropolished Nitinol, the sputtered Nitinol film material reveals Nickel depletion and an Oxygen-to-Titanium intensity ratio of ∼2:1 in the surface oxide layer, as measured by AES. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1176-1181, 2016.

  2. iStent trabecular micro-bypass stent for open-angle glaucoma

    PubMed Central

    Le, Kim; Saheb, Hady

    2014-01-01

    Trabecular micro-bypass stents, commonly known as iStents, are micro-invasive glaucoma surgery (MIGS) devices used to treat open-angle glaucoma. Like other MIGS procedures that enhance trabecular outflow, the iStent lowers intraocular pressure (IOP) by creating a direct channel between the anterior chamber and Schlemm’s canal. iStents are typically implanted at the time of phacoemulsification for patients with open-angle glaucoma and visually significant cataracts. This review summarizes the published data regarding the efficacy, safety, and cost considerations of trabecular micro-bypass stents. Most studies found statistically significant reductions in mean IOP and ocular medication use after combined phacoemulsification with single or double iStent implantation. The devices were found to be very safe, with a safety profile similar to that of cataract surgery. Complications were infrequent, with the most common complications being temporary stent obstruction or malposition, which resolved with observation or secondary procedures. Future studies are needed to evaluate long-term outcomes, patient satisfaction, cost effectiveness, and expanded indications. PMID:25284980

  3. Novel Use of a Uniquely Designed, Lumen-Apposing, Metal Stent in Benign Gastric Outlet Obstruction in Two Patients

    PubMed Central

    Pathirana, Induruwa; Magulick, John; Domanski, Jeremy; Okoh, Emuejevoke; Womeldorph, Craig

    2017-01-01

    Current guidelines recommend management of benign gastric outlet obstruction (GOO) with serial dilations. Self-expanding metal stents are effective, but their use is complicated by high rates of migration. We present two cases from our institution where a uniquely designed, lumen-apposing metal stent (LAMS) was successfully used to alleviate benign GOO without stent migration. PMID:28184377

  4. Role of metallic stents in benign esophageal stricture

    NASA Astrophysics Data System (ADS)

    Shim, Chan Sup

    2012-10-01

    Simple esophageal strictures, which are focal, straight, and large in diameter, usually require 1 - 3 dilation sessions to relieve symptoms. However, complex strictures, which are long, tortuous, or associated with a severely compromised luminal diameter, are usually more difficult to treat with conventional bougie or balloon dilation techniques, and often have high recurrence rates. Although the permanent placement of self-expandable metal stents (SEMS) has been used to manage refractory benign esophageal strictures, this procedure is associated with additional problems, such as stricture from tissue hyperplasia, stent migration, and fistula formation. Thus, several new types of stents have been developed, including temporary SEMS, self-expandable plastic stents (SEPS), and biodegradable stents. The use of these new products has produced varied results. Temporary SEMS that have been used to relieve benign esophageal conditions have caused granulation tissue at both ends of the stent because of contact between the mucosa and the exposed metal components of the stent, thus hindering stent removal. We examined the tissue response to two new types of SEMS, a flange-type and a straighttype, each coated with a silicone membrane on the outside of the metal mesh. These two SEMS were evaluated individually and compared with a conventional control stent in animal experiments. Although the newly designed stents resulted in reduced tissue hyperplasia, and were thus more easily separated from the esophageal tissue, some degree of tissue hyperplasia did occur. We suggest that newly designed DES (drug-eluting stents) may provide an alternative tool to manage refractory benign esophageal stricture.

  5. EUS-guided biliary drainage with placement of a new partially covered biliary stent for palliation of malignant biliary obstruction: a case series.

    PubMed

    Fabbri, C; Luigiano, C; Fuccio, L; Polifemo, A M; Ferrara, F; Ghersi, S; Bassi, M; Billi, P; Maimone, A; Cennamo, V; Masetti, M; Jovine, E; D'Imperio, N

    2011-05-01

    Endoscopic ultrasonography-guided biliary drainage (EUS-BD) has been developed as an alternative drainage technique in patients with obstructive jaundice where endoscopic retrograde cholangiopancreatography (ERCP) has failed. Between July 2008 and December 2009, 16 patients (9 men; median age 79 years) with biliopancreatic malignancy, who were candidates for alternative techniques of biliary decompression because ERCP had been unsuccessful, underwent EUS-BD with placement of a transmural or transpapillary partially covered nitinol self-expandable metal stent (SEMS). EUS-assisted cholangiography was successful in all patients, with definition of the relevant anatomy, but biliary drainage was successfully performed in only 12 (75 %) of the 16 patients (9 choledochoduodenostomies with SEMS placement and 3 biliary rendezvous procedures with papillary SEMS placement), with regression of the cholestasis. No major complications and no procedure-related deaths occurred. There was one case of pneumoperitoneum which was managed conservatively. The median follow-up was 170 days. During the follow-up, eight patients of the 12 patients in whom biliary draining was successful died; four are currently alive. None of the patients required endoscopic reintervention. This series demonstrated that EUS-BD with a partially covered SEMS has a high rate of clinical success and low complication rates, and could represent an alternative choice for biliary decompression.

  6. Transcatheter retrieval and repositioning of embolized stent from the right ventricle in an infant.

    PubMed

    Kobayashi, Daisuke; Singh, Harinder R; Turner, Daniel R; Forbes, Thomas J; Gowda, Srinath T

    2012-01-01

    Intracardiac stent embolization is a challenging complication in a small infant. A Palmaz stent was placed across the atrial septum in a 3-month-old boy to relieve symptoms of right-side heart failure. On routine chest radiography one week later, the stent was found to have embolized into the right ventricle. The stent was retrieved and repositioned by means of transcatheter technique, without subsequent complications. We found this method to be a viable alternative to surgery in a high-risk infant. To our knowledge, this is the first report of the successful transcatheter retrieval and repositioning of an expandable intravascular stent from an intraventricular position in an infant.

  7. Rapid, Reliable Shape Setting of Superelastic Nitinol for Prototyping Robots

    PubMed Central

    Gilbert, Hunter B.; Webster, Robert J.

    2016-01-01

    Shape setting Nitinol tubes and wires in a typical laboratory setting for use in superelastic robots is challenging. Obtaining samples that remain superelastic and exhibit desired precurvatures currently requires many iterations, which is time consuming and consumes a substantial amount of Nitinol. To provide a more accurate and reliable method of shape setting, in this paper we propose an electrical technique that uses Joule heating to attain the necessary shape setting temperatures. The resulting high power heating prevents unintended aging of the material and yields consistent and accurate results for the rapid creation of prototypes. We present a complete algorithm and system together with an experimental analysis of temperature regulation. We experimentally validate the approach on Nitinol tubes that are shape set into planar curves. We also demonstrate the feasibility of creating general space curves by shape setting a helical tube. The system demonstrates a mean absolute temperature error of 10°C. PMID:27648473

  8. Surface Modification of Nitinol by Chemical and Electrochemical Etching

    NASA Astrophysics Data System (ADS)

    Yang, Zhendi; Wei, Xiaojin; Cao, Peng; Gao, Wei

    2013-07-01

    In this paper, Nitinol, an equiatomic binary alloy of nickel and titanium, was surface modified for its potential biomedical applications by chemical and electrochemical etching. The main objective of the surface modification is to reduce the nickel content on the surface of Nitinol and simultaneously to a rough surface microstructure. As a result, better biocompatibility and better cell attachment would be achieved. The effect of the etching parameters was investigated, using scanning electron microscopy (SEM) equipped with energy dispersive X-ray spectrometry (EDX) and X-ray photoelectron spectrometry (XPS). The corrosion property of modified Nitinol surfaces was investigated by electrochemical work station. After etching, the Ni content in the surface layer has been reduced and the oxidation of Ti has been enhanced.

  9. Rapid, Reliable Shape Setting of Superelastic Nitinol for Prototyping Robots.

    PubMed

    Gilbert, Hunter B; Webster, Robert J

    Shape setting Nitinol tubes and wires in a typical laboratory setting for use in superelastic robots is challenging. Obtaining samples that remain superelastic and exhibit desired precurvatures currently requires many iterations, which is time consuming and consumes a substantial amount of Nitinol. To provide a more accurate and reliable method of shape setting, in this paper we propose an electrical technique that uses Joule heating to attain the necessary shape setting temperatures. The resulting high power heating prevents unintended aging of the material and yields consistent and accurate results for the rapid creation of prototypes. We present a complete algorithm and system together with an experimental analysis of temperature regulation. We experimentally validate the approach on Nitinol tubes that are shape set into planar curves. We also demonstrate the feasibility of creating general space curves by shape setting a helical tube. The system demonstrates a mean absolute temperature error of 10°C.

  10. CHARACTERIZING SURFACE LAYERS IN NITINOL USING X-RAY PHOTOELECTRON SPECTROSCOPY

    SciTech Connect

    Christopfel, R.; Mehta, A.

    2008-01-01

    Nitinol is a shape memory alloy whose properties allow for large reversible deformations and a return to its original geometry. This nickel-titanium (NiTi) alloy has become a material used widely in the biomedical fi eld as a stent to open up collapsed arteries. Both ambient and biological conditions cause surface oxidation in these devices which in turn change its biocompatibility. The thickness of oxidized layers can cause fractures in the material if too large and can allow for penetration if too thin. Depending on the type and abundance of the chemical species on or near the surface, highly toxic metal ions can leak into the body causing cell damage or even cell death. Thus, biocompatibility of such devices is crucial. By using highly surface sensitive x-ray photoelectron spectroscopy to probe the surface of these structures, it is possible to decipher both layer composition and layer thickness. Two samples, both of which were mechanically polished, were investigated. Of the two samples, one was then exposed to a phosphate buffered saline (PBS) solution to mimic the chemical properties of blood, while the other remained unexposed. Although both samples were found to have oxide layers of appropriate thickness (on the order of a few nm), it was found that the sample exposed to the saline solution had a slightly thicker oxide layer and more signifi cantly, a phosphate layer very near the surface suggesting toxic metal components are well contained within the sample. These are considerable indications of a biocompatible device.

  11. Fabrication and In Vitro Deployment of a Laser-Activated Shape Memory Polymer Vascular Stent

    SciTech Connect

    Baer, G M; Small IV, W; Wilson, T S; Benett, W J; Matthews, D L; Hartman, J; Maitland, D J

    2007-04-25

    Vascular stents are small tubular scaffolds used in the treatment of arterial stenosis (narrowing of the vessel). Most vascular stents are metallic and are deployed either by balloon expansion or by self-expansion. A shape memory polymer (SMP) stent may enhance flexibility, compliance, and drug elution compared to its current metallic counterparts. The purpose of this study was to describe the fabrication of a laser-activated SMP stent and demonstrate photothermal expansion of the stent in an in vitro artery model. A novel SMP stent was fabricated from thermoplastic polyurethane. A solid SMP tube formed by dip coating a stainless steel pin was laser-etched to create the mesh pattern of the finished stent. The stent was crimped over a fiber-optic cylindrical light diffuser coupled to an infrared diode laser. Photothermal actuation of the stent was performed in a water-filled mock artery. At a physiological flow rate, the stent did not fully expand at the maximum laser power (8.6 W) due to convective cooling. However, under zero flow, simulating the technique of endovascular flow occlusion, complete laser actuation was achieved in the mock artery at a laser power of {approx}8 W. We have shown the design and fabrication of an SMP stent and a means of light delivery for photothermal actuation. Though further studies are required to optimize the device and assess thermal tissue damage, photothermal actuation of the SMP stent was demonstrated.

  12. Lethal Hemorrhage Caused by Aortoenteric Fistula Following Endovascular Stent Implantation

    SciTech Connect

    Kahlke, Volker; Brossmann, Joachim; Klomp, Hans-Juergen

    2002-06-15

    A 55-year-old women developed an aortointestinal fistula between the bifurcation of the aorta and the distal ileum following implantation of multiple endovascular stents into both common iliac arteries for treatment of aortoiliac occlusive disease. Ten months before the acute onset of the gastrointestinal hemorrhage two balloon-expandable steel stents had been implanted into both common iliac arteries. Due to restenosis and recurrent intermittent claudication, three balloon-expandable covered stents were implanted 4 months later on reintervention. The patient presented with abdominal pain and melena, and fell into hemorrhagic shock with signs of upper gastrointestinal bleeding. After transfer to our hospital, she again developed hemorrhagic shock with massive upper and lower gastrointestinal bleeding and died during emergency laparotomy. The development of aortoenteric fistulas following endovascular surgery/stent implantation is very rare and has to be considered in cases of acute gastrointestinal hemorrhage.

  13. The Thermobile: A Nitinol-Based Scientific Toy.

    ERIC Educational Resources Information Center

    Kauffman, George B.; Mayo, Isaac

    1998-01-01

    Provides information on the use of a toy engine with no visible power source that is designed to demonstrate the conversion of low-temperature thermal energy to mechanical energy by means of a Nitinol loop wrapped around a system of two pulleys. (DDR)

  14. Texture evolution during nitinol martensite detwinning and phase transformation

    SciTech Connect

    Cai, S.; Schaffer, J. E.; Ren, Y.

    2013-12-09

    Nitinol has been widely used to make medical devices for years due to its unique shape memory and superelastic properties. However, the texture of the nitinol wires has been largely ignored due to inherent complexity. In this study, in situ synchrotron X-ray diffraction has been carried out during uniaxial tensile testing to investigate the texture evolution of the nitinol wires during martensite detwinning, variant reorientation, and phase transformation. It was found that the thermal martensitic nitinol wire comprised primarily an axial (1{sup ¯}20), (120), and (102)-fiber texture. Detwinning initially converted the (120) and (102) fibers to the (1{sup ¯}20) fiber and progressed to a (1{sup ¯}30)-fiber texture by rigid body rotation. At strains above 10%, the (1{sup ¯}30)-fiber was shifted to the (110) fiber by (21{sup ¯}0) deformation twinning. The austenitic wire exhibited an axial (334)-fiber, which transformed to the near-(1{sup ¯}30) martensite texture after the stress-induced phase transformation.

  15. Thulium fiber laser damage to Nitinol stone baskets

    NASA Astrophysics Data System (ADS)

    Wilson, Christopher R.; Hardy, Luke A.; Irby, Pierce B.; Fried, Nathaniel M.

    2015-02-01

    Our laboratory is studying the experimental Thulium fiber laser (TFL) as an alternative lithotripter to clinical gold standard Holmium:YAG laser. Safety studies characterizing undesirable Holmium laser-induced damage to Nitinol stone baskets have been previously reported. Similarly, this study characterizes TFL induced stone basket damage. A TFL beam with pulse energy of 35 mJ, pulse duration of 500 μs, and pulse rates of 50-500 Hz was delivered through 100-μm-core optical fibers, to a standard 1.9-Fr Nitinol stone basket wire. Stone basket damage was graded as a function of pulse rate, number of pulses, and working distance. Nitinol wire damage decreased with working distance and was non-existent at distances greater than 1.0 mm. In contact mode, 500 pulses delivered at pulse rates >= 200 Hz (<= 2.5 s) were sufficient to cut Nitinol wires. The Thulium fiber laser, operated in low pulse energy and high pulse rate mode, may provide a greater safety margin than standard Holmium laser for lithotripsy, as evidenced by shorter non-contact working distances for stone basket damage than previously reported with Holmium laser.

  16. Texture evolution during nitinol martensite detwinning and phase transformation

    NASA Astrophysics Data System (ADS)

    Cai, S.; Schaffer, J. E.; Ren, Y.; Yu, C.

    2013-12-01

    Nitinol has been widely used to make medical devices for years due to its unique shape memory and superelastic properties. However, the texture of the nitinol wires has been largely ignored due to inherent complexity. In this study, in situ synchrotron X-ray diffraction has been carried out during uniaxial tensile testing to investigate the texture evolution of the nitinol wires during martensite detwinning, variant reorientation, and phase transformation. It was found that the thermal martensitic nitinol wire comprised primarily an axial (1¯20), (120), and (102)-fiber texture. Detwinning initially converted the (120) and (102) fibers to the (1¯20) fiber and progressed to a (1¯30)-fiber texture by rigid body rotation. At strains above 10%, the (1¯30)-fiber was shifted to the (110) fiber by (21¯0) deformation twinning. The austenitic wire exhibited an axial (334)-fiber, which transformed to the near-(1¯30) martensite texture after the stress-induced phase transformation.

  17. Update in urethral stents.

    PubMed

    Bahouth, Z; Meyer, G; Yildiz, G; Nativ, O; Moskovitz, B

    2016-10-01

    Urethral stents were first introduced in 1988, and since then, they have undergone significant improvements. However, they did not gain a wide popularity and their use is limited to a small number of centers around the world. Urethral stents can be used in the entire urethra and for various and diverse indications. In the anterior urethra, it can be used to treat urethral strictures. In the prostatic urethra, they can be used for the treatment of prostatic obstruction, including benign, malignant and iatrogenic prostatic obstruction. Moreover, although not widely used, it can be also applied for the treatment of posterior urethral stricture and bladder neck contracture, usually resulting in urinary incontinence and the need for subsequent procedures. Our main experience are with Allium urethral stents, and as such, we provide the latest updates in urethral stents with special emphasis on the various types of Allium urethral stents: bulbar, prostatic and bladder neck stents.

  18. Gastric and Duodenal Stents: Follow-Up and Complications

    SciTech Connect

    Pinto Pabon, Isabel Teresa; Paul Diaz, Laura; Ruiz de Adana, Juan Carlos; Lopez Herrero, Julio

    2001-05-15

    Purpose: To assess the efficacy of self-expanding metallic stents in treating inoperable gastric and duodenal stenoses during follow-up and to evaluate the complications encountered.Methods: A total of 31 patients suffering from gastroduodenal obstruction (29 malignant, 2 benign) were treated with a self-expanding metallic stent (Wallstent). In 24 cases insertion was by the peroral route, in seven cases via gastrostomy.Results: All the strictures were successfully negotiated under fluoroscopic guidance without having to resort to endoscopy. A total of 27 patients (87%) were able to resume a regular diet, a soft diet, or a liquid diet orally. Complications included one case of stent malpositioning, one case of leakage of ascitic fluid through the gastrostomy orifice, one case of perforation and fistula to the biliary tree, and two cases of hematemesis. In two patients (6%) additional stents were implanted to improve patency. In all patients follow-up was maintained until death. Recurrence of symptoms immediately before death occurred in seven cases (23%). Mean survival time of patients was 13.3 weeks (SE {+-} 4.6).Conclusions: The deployment of gastroduodenal stents resulted in good palliation of inoperable gastric and duodenal stenoses. Certain technical aspects, e.g., adaptation of stents to bowel morphology, is critical to proper stent function and avoidance of complications.

  19. Palliative Airway Stenting Performed Under Radiological Guidance and Local Anesthesia

    SciTech Connect

    Profili, Stefano; Manca, Antonio; Feo, Claudio F. Padua, Guglielmo; Ortu, Riccardo; Canalis, Giulio C.; Meloni, Giovanni B.

    2007-02-15

    Purpose. To assess the effectiveness of airway stenting performed exclusively under radiological guidance for the palliation of malignant tracheobronchial strictures. Methods. We report our experience in 16 patients with malignant tracheobronchial stricture treated by insertion of 20 Ultraflex self-expandable metal stents performed under fluoroscopic guidance only. Three patients presented dysphagia grade IV due to esophageal malignant infiltration; they therefore underwent combined airway and esophageal stenting. All the procedures were performed under conscious sedation in the radiological room; average procedure time was around 10 min, but the airway impediment never lasted more than 40 sec. Results. We obtained an overall technical success in 16 cases (100%) and clinical success in 14 patients (88%). All prostheses were successfully placed without procedural complications. Rapid clinical improvement with symptom relief and normalization of respiratory function was obtained in 14 cases. Two patients died within 48 hr from causes unrelated to stent placement. Two cases (13%) of migration were observed; they were successfully treated with another stent. Tumor overgrowth developed in other 2 patients (13%); however, no further treatment was possible because of extensive laryngeal infiltration. Conclusions. Tracheobronchial recanalization with self-expandable metal stents is a safe and effective palliative treatment for malignant strictures. Airway stenting performed exclusively under fluoroscopic view was rapid and well tolerated.

  20. [Advantages of endoscopic stenting for malignant gastrointestinal obstructions].

    PubMed

    Meier, P N; Manns, M P

    2006-03-01

    Self-expanding stents play a major role in the interdisciplinary treatment of gastrointestinal obstructions in patients with local nonresectable tumors, advanced metastasis, and pronounced comorbidity. Reinstenting the passage and sealing esophagotracheal fistulae is very effective as palliative treatment for esophageal tumor complications. In hepatobiliary occlusions, the success rate against cholestasis is also high. Enteral and colorectal stents are gaining favor. Required are an experienced endoscopy team and adequate equipment. The rate of procedural complications is generally low, but rare and severe complications such as perforation must be considered. Further improvements in the materials and construction of stents can be expected.

  1. Stenting in the Treatment of Acute Ischemic Stroke: Literature Review

    PubMed Central

    Samaniego, Edgar A.; Dabus, Guilherme; Linfante, Italo

    2011-01-01

    Recanalization of acute large artery occlusions is a strong predictor of good outcome. The development of thrombectomy devices resulted in a significant improvement in recanalization rates compared to thrombolytics alone. However, clinical trials and registries with these thrombectomy devices in acute ischemic stroke (AIS) have shown recanalization rates in the range of 40–81%. The last decade has seen the development of nickel titanium self-expandable stents (SES). These stents, in contrast to balloon-mounted stents, allow better navigability and deployment in tortuous vessels and therefore are optimal for the cerebral circulation. SES were initially used for stent-assisted coil embolization of intracranial aneurysms and for treatment of intracranial stenosis. However, a few authors have recently reported feasibility of deployment of SES in AIS. The use of these devices yielded higher recanalization rates compared to traditional thrombectomy devices. Encouraged by these results, retrievable SES systems have been recently used in AIS. These devices offer the advantage of resheathing and retrieving of the stent even after full deployment. Some of these stents can also be detached in case permanent stent placement is needed. Retrievable SES are being used in Europe and currently tested in clinical trials in the United States. We review the recent literature in the use of stents for the treatment of AIS secondary to large vessel occlusion. PMID:22163225

  2. Thermomechanical Properties, Collapse Pressure, and Expansion of Shape Memory Polymer Neurovascular Stent Prototypes

    PubMed Central

    Baer, Géraldine M.; Wilson, Thomas S.; Small, Ward; Hartman, Jonathan; Benett, William J.; Matthews, Dennis L.; Maitland, Duncan J.

    2011-01-01

    Shape memory polymer stent prototypes were fabricated from thermoplastic polyurethane. Commercial stents are generally made of stainless steel or other alloys. These alloys are too stiff and prevent most stent designs from being able to navigate small and tortuous vessels to reach intracranial lesions. A solid tubular model and a high flexibility laser etched model are presented. The stents were tested for collapse in a pressure chamber. At 37°C, the full collapse pressure was comparable to that of commercially available stents, and higher than the estimated maximum pressure exerted by intracranial arteries. However, there is a potential for onset of collapse, which needs further study. The stents were crimped and expanded, the laser-etched stent showed full recovery with an expansion ratio of 2.7 and a 1% axial shortening. PMID:19107804

  3. A Computational Framework to Model Degradation of Biocorrodible Metal Stents Using an Implicit Finite Element Solver.

    PubMed

    Debusschere, Nic; Segers, Patrick; Dubruel, Peter; Verhegghe, Benedict; De Beule, Matthieu

    2016-02-01

    Bioresorbable stents represent an emerging technological development within the field of cardiovascular angioplasty. Their temporary presence avoids long-term side effects of non-degradable stents such as in-stent restenosis, late stent thrombosis and fatigue induced strut fracture. Several numerical modelling strategies have been proposed to evaluate the transitional mechanical characteristics of biodegradable stents using a continuum damage framework. However, these methods rely on an explicit finite-element integration scheme which, in combination with the quasi-static nature of many simulations involving stents and the small element size needed to model corrosion mechanisms, results in a high computational cost. To reduce the simulation times and to expand the general applicability of these degradation models, this paper investigates an implicit finite element solution method to model degradation of biodegradable stents.

  4. Virtual Stenting Workflow with Vessel-Specific Initialization and Adaptive Expansion for Neurovascular Stents and Flow Diverters

    PubMed Central

    Xu, Jinhui; Xiang, Jianping; Siddiqui, Adnan; Yang, Xinjian; Li, Haiyun; Meng, Hui

    2016-01-01

    Endovascular intervention using traditional neurovascular stents and densely braided flow diverters (FDs) have become the preferred treatment strategies for traditionally challenging intracranial aneurysms (IAs). Modeling stent and FD deployment in patient-specific aneurysms and its flow modification results prior to the actual intervention can potentially predict the patient outcome and treatment optimization. We present a clinically focused, streamlined virtual stenting workflow that efficiently simulates stent and FD treatment in patient-specific aneurysms based on expanding a simplex mesh structure. The simplex mesh is generated using an innovative vessel-specific initialization technique, which uses the patient’s parent artery diameter to identify the initial position of the simplex mesh inside the artery. A novel adaptive expansion algorithm enables the acceleration of deployment process by adjusting the expansion forces based on the distance of the simplex mesh from the parent vessel. The virtual stenting workflow was tested by modeling the treatment of two patient-specific aneurysms using the Enterprise stent and the Pipeline Embolization Device (commercial FD). Both devices were deployed in the aneurysm models in a few seconds. Computational fluid dynamics analyses of pre- and post-treatment aneurysmal hemodynamics show flow reduction in the aneurysmal sac in treated aneurysms, with the FD diverting more flow than the Enterprise stent. The test results show that this workflow can rapidly simulate clinical deployment of stents and FDs, hence paving the way for its future clinical implementation. PMID:26899135

  5. Myths and Truths of Nitinol Mechanics: Elasticity and Tension-Compression Asymmetry

    NASA Astrophysics Data System (ADS)

    Bucsek, Ashley N.; Paranjape, Harshad M.; Stebner, Aaron P.

    2016-09-01

    Two prevalent myths of Nitinol mechanics are examined: (1) Martensite is more compliant than austenite; (2) Texture-free Nitinol polycrystals do not exhibit tension-compression asymmetry. By reviewing existing literature, the following truths are revealed: (1) Martensite crystals may be more compliant, equally stiff, or stiffer than austenite crystals, depending on the orientation of the applied load. The Young's Modulus of polycrystalline Nitinol is not a fixed number—it changes with both processing and in operando deformations. Nitinol martensite prefers to behave stiffer under compressive loads and more compliant under tensile loads. (2) Inelastic Nitinol martensite deformation in and of itself is asymmetric, even for texture-free polycrystals. Texture-free Nitinol polycrystals also exhibit tension-compression transformation asymmetry.

  6. Application of a mechanobiological simulation technique to stents used clinically.

    PubMed

    Boyle, Colin J; Lennon, Alex B; Prendergast, Patrick J

    2013-03-15

    Many cardiovascular diseases are characterised by the restriction of blood flow through arteries. Stents can be expanded within arteries to remove such restrictions; however, tissue in-growth into the stent can lead to restenosis. In order to predict the long-term efficacy of stenting, a mechanobiological model of the arterial tissue reaction to stress is required. In this study, a computational model of arterial tissue response to stenting is applied to three clinically relevant stent designs. We ask the question whether such a mechanobiological model can differentiate between stents used clinically, and we compare these predictions to a purely mechanical analysis. In doing so, we are testing the hypothesis that a mechanobiological model of arterial tissue response to injury could predict the long-term outcomes of stent design. Finite element analysis of the expansion of three different stent types was performed in an idealised, 3D artery. Injury was calculated in the arterial tissue using a remaining-life damage mechanics approach. The inflammatory response to this initial injury was modelled using equations governing variables which represented tissue-degrading species and growth factors. Three levels of inflammation response were modelled to account for inter-patient variability. A lattice-based model of smooth muscle cell behaviour was implemented, treating cells as discrete agents governed by local rules. The simulations predicted differences between stent designs similar to those found in vivo. It showed that the volume of neointima produced could be quantified, providing a quantitative comparison of stents. In contrast, the differences between stents based on stress alone were highly dependent on the choice of comparison criteria. These results show that the choice of stress criteria for stent comparisons is critical. This study shows that mechanobiological modelling may provide a valuable tool in stent design, allowing predictions of their long

  7. Active Control of Flexible Space Structures Using the Nitinol Shape Memory Actuators

    DTIC Science & Technology

    1987-10-01

    number) FIELD !GROUP SUBGROUP I Active Control, Nitinol Actuators, Space Structures 9. ABSTRACT (Continue on reverse if necessary and identify by block...number) Summarizes research progress in the feasibility demonstration of active vibration control using Nitinol shape memory actuators. Tests on...FLEXIBLE SPACE STRUCTURES USING NITINOL SHAPE MEMORY ACTUATORS FINAL REPORT FOR PHASE I SDIO CONTRACT #F49620-87-C-0035 0 BY DR. AMR M. BAZ KARIM R

  8. Comparison of Nitinol Stapes Pistons with Conventional Stapes Pistons: A Cadaver Study

    DTIC Science & Technology

    2011-01-01

    Comparison of Nitinol Stapes Pistons with Conventional Stapes Pistons: A Cadaver Study Samuel A. Spear1 and James V. Crawford2 1 48th Medical Group, ENT...cited. Objective. To visually compare the Nitinol “smart” stapes prosthesis to conventional manual crimping stapes pistons in temporal bone cadaver...answer questions about each stapes piston. The answers to the survey were then recorded for analysis. Results. 8 of 9 Nitinol pistons were described as

  9. On the Stressing of Annealed NITINOL: The Electrical Resistance and Calorimetric Effects

    DTIC Science & Technology

    1987-04-01

    Security Classification) On the Stressing of Annealed NITINOL : The Electrical Resistance and Calorimetric Effects 12 PERSONAL AUTHOR(S) Goldstein, David...COSATI CODES 18 SUBJECT TERMS (Continue on reverse if necessary and identify by blck numbher) FIELD GROUP SUB-GROUP NITINOL 06 Shape Memory Alloy 13 o i...calorimetry curves of NITINOL during its phase transformation are substantial. The generation of a peak occurs in the resistance curve, and an additional

  10. Surgical failure after colonic stenting as a bridge to surgery

    PubMed Central

    Kim, Jung Ho; Kwon, Kwang An; Lee, Jong Joon; Lee, Won-Suk; Baek, Jeong-Heum; Kim, Yoon Jae; Chung, Jun-Won; Kim, Kyoung Oh; Park, Dong Kyun; Kim, Ju Hyun

    2014-01-01

    AIM: To identify risk factors for surgical failure after colonic stenting as a bridge to surgery in left-sided malignant colonic obstruction. METHODS: The medical records of patients who underwent stent insertion for malignant colonic obstruction between February 2004 and August 2012 were retrospectively reviewed. Patients with malignant colonic obstruction had overt clinical symptoms and signs of obstruction. Malignant colonic obstruction was diagnosed by computed tomography and colonoscopy. A total of 181 patients underwent stent insertion during the study period; of these, 68 consecutive patients were included in our study when they had undergone stent placement as a bridge to surgery in acute left-sided malignant colonic obstruction due to primary colon cancer. RESULTS: Out of 68 patients, forty-eight (70.6%) were male, and the mean age was 64.9 (range, 38-89) years. The technical and clinical success rates were 97.1% (66/68) and 88.2% (60/68), respectively. Overall, 85.3% (58/68) of patients underwent primary tumor resection and primary anastomosis. Surgically successful preoperative colonic stenting was achieved in 77.9% (53/68). The mean duration, defined as the time between the SEMS attempt and surgery, was 11.3 d (range, 0-26 d). The mean hospital stay after surgery was 12.5 d (range, 6-55 d). On multivariate analysis, the use of multiple self-expanding metal stents (OR = 28.872; 95%CI: 1.939-429.956, P = 0.015) was a significant independent risk factor for surgical failure of preoperative stenting as a bridge to surgery. Morbidity and mortality rates in surgery after stent insertion were 4.4% (3/68) and 1.5% (1/68), respectively. CONCLUSION: The use of multiple self-expanding metal stents appears to be a risk factor for surgical failure. PMID:25206288

  11. Stents and surgical interventions in the palliation of gastric outlet obstruction: a systematic review

    PubMed Central

    Minata, Mauricio Kazuyoshi; Bernardo, Wanderley Marques; Rocha, Rodrigo Silva de Paula; Morita, Flavio Hiroshi Ananias; Aquino, Julio Cesar Martins; Cheng, Spencer; Zilberstein, Bruno; Sakai, Paulo; de Moura, Eduardo Guimarães Hourneaux

    2016-01-01

    Background and study aims: Palliative treatment of gastric outlet obstruction can be done with surgical or endoscopic techniques. This systematic review aims to compare surgery and covered and uncovered stent treatments for gastric outlet obstruction (GOO). Patients and methods: Randomized clinical trials were identified in MEDLINE, Embase, Cochrane, LILACs, BVS, SCOPUS and CINAHL databases. Comparison of covered and uncovered stents included: technical success, clinical success, complications, obstruction, migration, bleeding, perforation, stent fracture and reintervention. The outcomes used to compare surgery and stents were technical success, complications, and reintervention. Patency rate could not be included because of lack of uniformity of the extracted data. Results: Eight studies were selected, 3 comparing surgery and stents and 5 comparing covered and uncovered stents.The meta-analysis of surgical and endoscopic stent treatment showed no difference in the technical success and overall number of complications. Stents had higher reintervention rates than surgery (RD: 0.26, 95 % CI [0.05, 0.47], NNH: 4). There is no significant difference in technical success, clinical success, complications, stent fractures, perforation, bleeding and the need for reintervention in the analyses of covered and uncovered stents. There is a higher migration rate in the covered stent therapy compared to uncovered self-expanding metallic stents (SEMS) in the palliation of malignant GOO (RD: 0.09, 95 % CI [0.04, 0.14], NNH: 11). Nevertheless, covered stents had lower obstruction rates (RD: – 0.21, 95 % CI [-0.27, – 0.15], NNT: 5). Conclusions: In the palliation of malignant GOO, covered SEMS had higher migration and lower obstruction rates when compared with uncovered stents. Surgery is associated with lower reintervention rates than stents. PMID:27857965

  12. Two-year outcome after Xpert stent implantation for treating below the knee lesions in critical limb ischemia.

    PubMed

    Bosiers, Marc; Lioupis, Christos; Deloose, Koen; Verbist, Jürgen; Peeters, Patrick

    2009-01-01

    We investigated the efficacy of Xpert (Abbott Vascular, Abbott Park, IL) nitinol stents for the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia (CLI). Between May 2005 and November 2007, 94 CLI patients (70 male, mean age 73.5 years) received 134 Xpert stents in 102 limbs. Seventy-nine patients (71.2%) were scored as Rutherford Category 4, 31 patients (27.9%) as Category 5 and 1 patient (0.9%) as Category 6. Primary endpoint of this study was defined as 2-year duplex derived primary patency. Secondary endpoints were 2-year limb salvage rate and the absence of reintervention after the index procedure. Kaplan Meier analysis reported 2-year primary patency and limb salvage rates of 54.4% and 90.8%, respectively. Stratification by lesion location did not reveal any significant differences in 2-year primary patency rates in proximal and distal below the knee lesions. Our results suggest that treatment with nitinol Xpert stents can be considered effective for treating CLI patients, with satisfying patency outcome.

  13. Development of a static bioactive stent prototype and dynamic aneurysm-on-a-chip(TM) model for the treatment of aneurysms

    NASA Astrophysics Data System (ADS)

    Reece, Lisa M.

    Aneurysms are pockets of blood that collect outside blood vessel walls forming dilatations and leaving arterial walls very prone to rupture. Current treatments include: (1) clipping, and (2) coil embolization, including stent-assisted coiling. While these procedures can be effective, it would be advantageous to design a biologically active stent, modified with magnetic stent coatings, allowing cells to be manipulated to heal the arterial lining. Further, velocity, pressure, and wall shear stresses aid in the disease development of aneurysmal growth, but the shear force mechanisms effecting wound closure is elusive. Due to these factors, there is a definite need to cultivate a new stent device that will aid in healing an aneurysm in situ. To this end, a static bioactive stent device was synthesized. Additionally, to study aneurysm pathogenesis, a lab-on-a-chip device (a dynamic stent device) is the key to discovering the underlying mechanisms of these lesions. A first step to the reality of a true bioactive stent involves the study of cells that can be tested against the biomaterials that constitute the stent itself. The second step is to test particles/cells in a microfluidic environment. Therefore, biocompatability data was collected against PDMS, bacterial nanocellulose (BNC), and magnetic bacterial nanocellulose (MBNC). Preliminary static bioactive stents were synthesized whereby BNC was grown to cover standard nitinol stents. In an offshoot of the original research, a two-dimensional microfluidic model, the Aneurysm-on-a-ChipTM (AOC), was the logical answer to study particle flow within an aneurysm "sac" - this was the dynamic bioactive stent device. The AOC apparatus can track particles/cells when it is coupled to a particle image velocimetry software (PIV) package. The AOC fluid flow was visualized using standard microscopy techniques with commercial microparticles/cells. Movies were taken during fluid flow experiments and PIV was utilized to monitor.

  14. Stent intussusception after thromboaspiration through a platinum chrome stent: a particular case of longitudinal stent deformation.

    PubMed

    Mila, Rafael; Vignolo, Gustavo; Trujillo, Pedro

    2015-04-01

    The need to improve stent deliverability has led to the development of thinner and more flexible stents. However, there is concern about decreased longitudinal strength. The number of longitudinal stent deformation reports has dramatically increased. We report a case of stent longitudinal deformation after thromboaspiration through a new generation platinum chrome bare metal stent. Images show an "intussusception effect," an extreme form of the previously described "concertina deformation," as the mechanism of shortening. Since stent technology is constantly evolving, newer devices will probably be designed to have less susceptibility to longitudinal stent deformation.

  15. Addressing Machining Issues for the Intermetallic Compound 60-NITINOL

    NASA Technical Reports Server (NTRS)

    Stanford, Malcolm K.; Wozniak, Walter A.; McCue, Terry R.

    2012-01-01

    60-NITINOL (60 wt.% Ni - 40 wt.% Ti) is being studied as a material for advanced aerospace components. Frequent wire breakage during electrical-discharge machining of this material was investigated. The studied material was fabricated from hot isostatically pressed 60-NITINOL powder obtained through a commercial source. Bulk chemical analysis of the material showed that the composition was nominal but had relatively high levels of certain impurities, including Al and O. It was later determined that Al2O3 particles had contaminated the material during the hot isostatic pressing procedure and that these particles were the most likely cause of the wire breakage. The results of this investigation highlight the importance of material cleanliness to its further implementation.

  16. Hardness and Microstructure of Binary and Ternary Nitinol Compounds

    NASA Technical Reports Server (NTRS)

    Stanford, Malcolm K.

    2016-01-01

    The hardness and microstructure of twenty-six binary and ternary Nitinol (nickel titanium, nickel titanium hafnium, nickel titanium zirconium and nickel titanium tantalum) compounds were studied. A small (50g) ingot of each compound was produced by vacuum arc remelting. Each ingot was homogenized in vacuum for 48 hr followed by furnace cooling. Specimens from the ingots were then heat treated at 800, 900, 1000 or 1100 degree C for 2 hr followed by water quenching. The hardness and microstructure of each specimen was compared to the baseline material (55-Nitinol, 55 at.% nickel - 45 at.% titanium, after heat treatment at 900 degC). The results show that eleven of the studied compounds had higher hardness values than the baseline material. Moreover, twelve of the studied compounds had measured hardness values greater 600HV at heat treatments from 800 to 900 degree C.

  17. Thermophysical Properties of 60-NITINOL for Mechanical Component Applications

    NASA Technical Reports Server (NTRS)

    Stanford, Malcolm K.

    2012-01-01

    The linear thermal expansion coefficient, specific heat capacity, electrical resistivity and thermal conductivity of 60- NITINOL were studied over a range of temperatures representing the operating environment of an oil-lubricated bearing. The behavior of this material appears to follow wellestablished theories applicable to either metal alloys, in general, or to intermetallic compounds, more specifically and the measured data were found to be comparable to those for conventional bearing alloys.

  18. The electrochemical behavior of nitinol in simulated gastric fluid.

    PubMed

    Pound, Bruce G

    2016-08-29

    Increased use is being made of nitinol for implants that are exposed to gastric fluid. However, few corrosion studies have involved nitinol in an appropriate acidified chloride solution. In this work, the electrochemical behavior of electropolished (EP) nitinol was examined in simulated gastric fluid, the corresponding neutral solution with the same concentration (0.6%) of NaCl, and 0.9% NaCl. Cyclic potentiodynamic polarization was used to evaluate the susceptibility to pitting corrosion, while electrochemical impedance spectroscopy was used to examine the passive oxide film. The potentiodynamic tests showed that the susceptibility of EP nitinol to pitting corrosion is affected by chloride concentration and pH. Acidification, in particular, resulted in the susceptibility being markedly higher in gastric fluid compared with that in the corresponding neutral NaCl solution. The impedance data could be fitted using a parallel resistance-capacitance (as a constant phase element) circuit associated with the oxide film. The thickness of the oxide was determined from the capacitive component and found to be little affected by chloride concentration. In contrast, acidification increased the solubility of the oxide enough to decrease the thickness of the film from 5.3 nm in 0.6% NaCl to 4.2 nm in gastric fluid. The resistivity of the oxide obtained from the resistance was affected by chloride concentration (0.7 × 10(11) and 1.7 × 10(11) Ω m in 0.9% and 0.6% NaCl, respectively) and particularly by pH (6.3 × 10(11) Ω m in gastric fluid). The resistivity values suggest that the oxide was more defective in the neutral solutions. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2016.

  19. A Nitinol-Based Solar Array Deployment Mechanism

    NASA Technical Reports Server (NTRS)

    Choi, Shin John; Lu, Chia-Ao; Feland, John

    1996-01-01

    This document describes a simple, light weight, and scalable mechanism capable of deploying flexible or rigid substrate solar arrays that have been configured in an accordion-like folding scheme. This mechanism is unique in that it incorporates a Shape Memory Alloy (SMA) actuator made of Nitinol. This paper documents the design of the mechanism in full detail while offering to designers a foundation of knowledge by which they can develop future applications with SMA's.

  20. Clinical application of metallic stents in treatment of esophageal carcinoma

    PubMed Central

    Yang, Hai-Shan; Zhang, Lin-Bo; Wang, Tian-Wei; Zhao, Yong-Sheng; Liu, Lin

    2005-01-01

    AIM: To evaluate the effects of self-expanding metal stents (SEMS) in patients with malignant esophageal obstruction and to analyze their prognosis and complications. METHODS: Seventy-four metallic stents were placed under fluoroscopic guidance in 66 patients with esophageal obstruction secondary to carcinoma, of whom, 6 cases were complicated by fistula. RESULTS: After seventy-two stents were successfully used in 66 cases without any severe complications (technical successful rate was 97%), the dysphagia score improved from 3.3±0.6 to 0.8±0.5 (P<0.01), and life quality improved significantly in all these patients. All fistulae were sealed immediately after coated stents were inserted in the six patients. New stents were placed in two patients: the stent migrated more than 2 cm, in one patient and the stent slipped into stomach in the other. Minor bleeding was found only in 28 patients during the operation. Reobstruction was found in 12 patients, but was successfully cured under endoscopy. The survival rate was 78%, 57% and 11% for 6 mo, 1 year and 2 years respectively. CONCLUSION: Placement of SEMS is a simple, safe, quick and efficient surgical method for treating esophageal carcinoma obstruction. It may be used mainly as a palliative treatment of esophageal obstruction secondary to carcinoma. PMID:15637767

  1. Endovascular Gene Delivery from a Stent Platform: Gene- Eluting Stents.

    PubMed

    Fishbein, Ilia; Chorny, Michael; Adamo, Richard F; Forbes, Scott P; Corrales, Ricardo A; Alferiev, Ivan S; Levy, Robert J

    A synergistic impact of research in the fields of post-angioplasty restenosis, drug-eluting stents and vascular gene therapy over the past 15 years has shaped the concept of gene-eluting stents. Gene-eluting stents hold promise of overcoming some biological and technical problems inherent to drug-eluting stent technology. As the field of gene-eluting stents matures it becomes evident that all three main design modules of a gene-eluting stent: a therapeutic transgene, a vector and a delivery system are equally important for accomplishing sustained inhibition of neointimal formation in arteries treated with gene delivery stents. This review summarizes prior work on stent-based gene delivery and discusses the main optimization strategies required to move the field of gene-eluting stents to clinical translation.

  2. Endovascular Gene Delivery from a Stent Platform: Gene- Eluting Stents

    PubMed Central

    Fishbein, Ilia; Chorny, Michael; Adamo, Richard F; Forbes, Scott P; Corrales, Ricardo A; Alferiev, Ivan S; Levy, Robert J

    2015-01-01

    A synergistic impact of research in the fields of post-angioplasty restenosis, drug-eluting stents and vascular gene therapy over the past 15 years has shaped the concept of gene-eluting stents. Gene-eluting stents hold promise of overcoming some biological and technical problems inherent to drug-eluting stent technology. As the field of gene-eluting stents matures it becomes evident that all three main design modules of a gene-eluting stent: a therapeutic transgene, a vector and a delivery system are equally important for accomplishing sustained inhibition of neointimal formation in arteries treated with gene delivery stents. This review summarizes prior work on stent-based gene delivery and discusses the main optimization strategies required to move the field of gene-eluting stents to clinical translation. PMID:26225356

  3. [Stent implantation in the treatment of pharynx anastomotic stenosis after cervical esophageal resection: a case report].

    PubMed

    Zang, Chuanshan; Sun, Jian; Sun, Yan

    2016-03-01

    We report the treatment of one patient with pharynx anastomotic stenosis after cervical esophagealresection by stent implantation. The patient suffered from serious pharynx anastomotic stenosis after gastric-pha-ryngeal anastomosis. After balloon-dilatation,a domestic self-expanding Z-stents was implanted in the stricture ofthe esophagus under the X-rays. After stent implantation, the patient has been leading a normal life for threeyears. Balloon dilatation and stent implantation is an effective and safe method in the treatment of patients withpharynx anastomotic stenosis.

  4. Fracture of Polymer-Coated Nitinol During Gamma Sterilization

    NASA Astrophysics Data System (ADS)

    Norwich, Dennis W.

    2012-12-01

    After gamma sterilization of a packaged medical device, fractures were discovered in the superelastic nitinol wire used as part of the assembly. The nitinol wire was encased in fluorinated ethylene propylene (FEP) shrink tube. The only fractures occurred where the encased wire was held under strain during gamma sterilization. A study was conducted to determine the susceptibility of nitinol to this type of failure. The variables studied included wire diameter, wire surface finish, wire oxide layer, quantity of wires encased, type of tubing, and strain level during gamma sterilization. The greatest susceptibility to fracture occurred to single wire samples with a light oxide layer held under high strain in FEP shrink tube. Gamma sterilization experiments were conducted to isolate and confirm this failure mechanism. Scanning electron microscopy was used to analyze the fractured samples. Chemical analysis was performed in an attempt to detect trace elements to determine the root cause of the failures. Stress corrosion cracking caused by the liberation of fluorine due to the degradation of the polymer during gamma sterilization is suspected.

  5. Stent Recanalization of Chronic Portal Vein Occlusion in a Child

    SciTech Connect

    Cwikiel, Wojciech; Solvig, Jan; Schroder, Henrik

    2000-07-15

    An 8-year-old boy with a 21/2 year history of portal hypertension and repeated bleedings from esophageal varices, was referred for treatment. The 3.5-cm-long occlusion of the portal vein was passed and the channel created was stabilized with a balloon-expandable stent; a portosystemic stent-shunt was also created. The portosystemic shunt closed spontaneously within 1 month, while the recanalized segment of the portal vein remained open. The pressure gradient between the intrahepatic and extrahepatic portal vein branches dropped from 17 mmHg to 0 mmHg. The pressure in the portal vein dropped from 30 mmHg to 17 mmHg and the bleedings stopped. The next dilation of the stent was performed 12 months later due to an increased pressure gradient; the gastroesophageal varices disappeared completely. Further dilation of the stent was planned after 2, 4, and 6 years.

  6. A novel low-profile thin-film nitinol/silk endograft for treating small vascular diseases.

    PubMed

    Shayan, Mahdis; Yang, Sungyeun; Ryu, WonHyoung; Chun, Youngjae

    2017-04-01

    Since the introduction of various endovascular graft materials such as expanded polytetrafluoroethylene (e-PTFE) and Dacron(®) polyester, they have been rapidly applied in endovascular devices for treating a variety of clinical situations. While present endovascular grafts have been successful in treating large blood vessels, there are still significant challenges and limitations for small and tortuous vessels to their use. Recently, our group has demonstrated the potential to use thin-film nitinol (TFN) as a novel material to develop endografts used in the treatment of a wide range of small vascular diseases because TFN is ultralow profile (that is, a few micrometers thick), relatively thromboresistant, and superelastic. While TFN has shown superior thromboresistance, its surface endothelialization is not rapid and sufficient. Therefore, our laboratory has been exploring the feasibility of using thin-film silk as a novel coating for facilitating rapid and confluent endothelial cell growth. The purpose of this study is to fabricate a low-profile composite endograft using thin layers of nitinol and silk, and to evaluate both thrombogenicity as well as endothelial cell and smooth muscle cell responses. This study also evaluates the functionality of the composite endograft using an in vitro blood circulation model. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 575-584, 2017.

  7. Smart cymbal transducers with nitinol end caps tunable to multiple operating frequencies.

    PubMed

    Feeney, Andrew; Lucas, Margaret

    2014-10-01

    Cymbal flextensional transducers have principally been adopted for sensing and actuation and their performance in higher power applications has only recently been investigated. Nitinol is a shape-memory alloy (SMA) with excellent strain recovery, durability, corrosion resistance, and fatigue strength. Although it has been incorporated in many applications, the implementation of nitinol, or any of the SMAs, in power ultrasonic applications is limited. Nitinol exhibits two phenomena, the first being the superelastic effect and the second being the shape-memory effect (SME). This paper assesses two cymbal transducers, one assembled with superelastic nitinol end caps and the other with shape-memory nitinol end caps. Characterization of the nitinol alloy before the design of such transducers is vital, so that they can be tuned to the desired operating frequencies. It is shown this can be achieved for shape-memory nitinol using differential scanning calorimetry (DSC); however, it is also shown that characterizing superelastic nitinol with DSC is problematic. Two transducers are assembled whose two operating frequencies can be tuned, and their dynamic behaviors are compared. Both transducers are shown to be tunable, with limitation for high-power applications largely being associated with the bond layer.

  8. Hepatocellular Carcinoma Complicated by Gastroduodenal Obstruction: Palliative Treatment with Metallic Stent Placement

    SciTech Connect

    Lee, Ye Jin; Kim, Jin Hyoung Song, Ho-Young; Park, Jung-Hoon; Na, Han Kyu; Kim, Pyeong Hwa; Fan, Yong

    2012-10-15

    Purpose: To evaluate the clinical effectiveness of self-expandable metallic stents in seven patients with malignant gastroduodenal obstruction caused by inoperable hepatocellular carcinoma (HCC). Methods: Seven patients with gastroduodenal obstruction caused by advanced HCC underwent metallic stent placement from 2003 to 2010. These patients had total dysphagia (n = 5) or were able to eat only liquids (n = 2) before stent placement. Patients had Eastern Cooperative Oncology Group performance scores of 2 or 3, and Child-Pugh classification B or C. Results: Stent placement was technically successful in all seven patients (100%) and clinically successful in six (86%). Five patients could eat a soft diet, and one patient tolerated regular diet after stent placement. Stent-related obstructive jaundice occurred in one patient. One patient had hematemesis 11 days after stent placement. Overall mean survival was 51 days (range, 10-119 days). Stent patency was preserved in six patients with clinical success until death. Conclusion: Placement of a covered self-expandable metallic stent may offer good palliation in patients with gastroduodenal obstruction due to advanced HCC.

  9. Functional Nanoarchitectures For Enhanced Drug Eluting Stents.

    PubMed

    Saleh, Yomna E; Gepreel, Mohamed A; Allam, Nageh K

    2017-01-12

    Different strategies have been investigated to allow for optimum duration and conditions for endothelium healing through the enhancement of coronary stents. In this study, a nanoarchitectured system is proposed as a surface modification for drug eluting stents. Highly oriented nanotubes were vertically grown on the surface of a new Ni-free biocompatible Ti-based alloy, as a potential material for self-expandable stents. The fabricated nanotubes were self-grown from the potential stent substrate, which are also proposed to enhance endothelial proliferation while acting as drug reservoir to hinder Vascular Smooth Muscle Cells (VSMC) proliferation. Two morphologies were synthesized to investigate the effect of structure homogeneity on the intended application. The material was characterized by field-emission scanning electron microscope (FESEM), X-ray diffraction (XRD), Raman spectroscopy, energy dispersive X-ray spectroscopy (EDX), and X-ray photoelectron spectroscopy (XPS). Nanoindentation technique was used to study the mechanical properties of the fabricated material. Cytotoxicity and proliferation studies were performed and compared for the two fabricated nanoarchitectures, versus smooth untextured samples, using in-vitro cultured endothelial cells. Finally, the drug loading capacity was experimentally studied and further supported by computational modeling of the release profile.

  10. Functional Nanoarchitectures For Enhanced Drug Eluting Stents

    NASA Astrophysics Data System (ADS)

    Saleh, Yomna E.; Gepreel, Mohamed A.; Allam, Nageh K.

    2017-01-01

    Different strategies have been investigated to allow for optimum duration and conditions for endothelium healing through the enhancement of coronary stents. In this study, a nanoarchitectured system is proposed as a surface modification for drug eluting stents. Highly oriented nanotubes were vertically grown on the surface of a new Ni-free biocompatible Ti-based alloy, as a potential material for self-expandable stents. The fabricated nanotubes were self-grown from the potential stent substrate, which are also proposed to enhance endothelial proliferation while acting as drug reservoir to hinder Vascular Smooth Muscle Cells (VSMC) proliferation. Two morphologies were synthesized to investigate the effect of structure homogeneity on the intended application. The material was characterized by field-emission scanning electron microscope (FESEM), X-ray diffraction (XRD), Raman spectroscopy, energy dispersive X-ray spectroscopy (EDX), and X-ray photoelectron spectroscopy (XPS). Nanoindentation technique was used to study the mechanical properties of the fabricated material. Cytotoxicity and proliferation studies were performed and compared for the two fabricated nanoarchitectures, versus smooth untextured samples, using in-vitro cultured endothelial cells. Finally, the drug loading capacity was experimentally studied and further supported by computational modeling of the release profile.

  11. Functional Nanoarchitectures For Enhanced Drug Eluting Stents

    PubMed Central

    Saleh, Yomna E.; Gepreel, Mohamed A.; Allam, Nageh K.

    2017-01-01

    Different strategies have been investigated to allow for optimum duration and conditions for endothelium healing through the enhancement of coronary stents. In this study, a nanoarchitectured system is proposed as a surface modification for drug eluting stents. Highly oriented nanotubes were vertically grown on the surface of a new Ni-free biocompatible Ti-based alloy, as a potential material for self-expandable stents. The fabricated nanotubes were self-grown from the potential stent substrate, which are also proposed to enhance endothelial proliferation while acting as drug reservoir to hinder Vascular Smooth Muscle Cells (VSMC) proliferation. Two morphologies were synthesized to investigate the effect of structure homogeneity on the intended application. The material was characterized by field-emission scanning electron microscope (FESEM), X-ray diffraction (XRD), Raman spectroscopy, energy dispersive X-ray spectroscopy (EDX), and X-ray photoelectron spectroscopy (XPS). Nanoindentation technique was used to study the mechanical properties of the fabricated material. Cytotoxicity and proliferation studies were performed and compared for the two fabricated nanoarchitectures, versus smooth untextured samples, using in-vitro cultured endothelial cells. Finally, the drug loading capacity was experimentally studied and further supported by computational modeling of the release profile. PMID:28079127

  12. Malignant Gastroduodenal Obstruction: Treatment with Self-Expanding Uncovered Wallstent

    SciTech Connect

    Gutzeit, Andreas Binkert, Christoph A.; Schoch, Eric; Sautter, Thomas; Jost, Res; Zollikofer, Christoph L.

    2009-01-15

    Purpose: To retrospectively evaluate the clinical effectiveness of a self-expanding uncovered Wallstent in patients with malignant gastroduodenal obstruction. Materials and Methods: Under combined endoscopic and fluoroscopic guidance, 29 patients with a malignant gastroduodenal stenosis were treated with a self-expanding uncovered metallic Wallstent. A dysphagia score was assessed before and after the intervention to measure the success of this palliative therapy. The dysphagia score ranged between grade 0 to grade 4: grade 0 = able to tolerate solid food, grade 1 = able to tolerate soft food, grade 2 = able to tolerate thick liquids, grade 3 = able to tolerate water or clear fluids, and grade 4 = unable to tolerate anything perorally. Stent patency and patients survival rates were calculated. Results: The insertion of the gastroduodenal stent was technically successful in 28 patients (96.5%). After stenting, 25 patients (86.2%) showed clinical improvement by at least one score point. During follow-up, 22 (78.5%) of 28 patients showed no stent occlusion until death and did not have to undergo any further intervention. In six patients (20.6%), all of whom were treated with secondary stent insertions, occlusion with tumor ingrowth and/or overgrowth was observed after the intervention. The median period of primary stent patency in our study was 240 days. Conclusion: Placement of an uncovered Wallstent is clinically effective in patients with malignant gastroduodenal obstruction. Stent placement is associated with high technical success, good palliation effect, and high durability of stent function.

  13. Endovascular Stenting for Unsuccessful Angioplasty of the Aorta in Aortoarteritis

    SciTech Connect

    Tyagi, Sanjay; Kaul, Upkar A.; Arora, Ramesh

    1999-11-15

    Purpose: The efficacy and safety of endovascular stent implantation to correct dissection or a suboptimal result after percutaneous transluminal angioplasty (PTA) was evaluated in patients suffering from aortic stenosis due to aortoarteritis. Methods: Twelve children and young adults [aged (mean {+-} SD) 18.2 {+-} 8.7 years] underwent stent implantation after PTA of the aorta, seven for obstructive dissection, four for ineffective balloon dilatation, and one for recurrent restenosis. Nine patients underwent implantation of self-expandable stents and three received balloon-expandable Palmaz stents. Results: Stent implantation could be successfully performed in all 12 patients. After stent implantation, the peak systolic pressure gradient decreased from 91 {+-} 33.5 mmHg to 12.4 {+-} 12.5 mmHg (p < 0.001). The diameter of the stenosed segment increased from 4.6 {+-} 0.8 mm to 11.1 {+-} 1.9 mm (p < 0.001). The dissection was completely covered in all seven patients with dissection. Except for epigastric pain with vomiting in one patient, there was no complication. On follow-up, over 12-57 months (mean 26.8 {+-} 10.8 months), 11 patients (91.6%) had marked improvement in their blood pressure. Patients with congestive heart failure and claudication also showed improvement. Repeat catheterization in five patients, between 6-30 months (mean 16.8 {+-} 9.1 months) after stent implantation, showed sustained improvement in four and a fusiform, long segment, intrastent restenosis after 30 months in one child. The stenosis was safely redilated. Conclusion: Endovascular aortic stent implantation is safe and provides good immediate relief in patients with unsatisfactory results after balloon angioplasty. Improvement is sustained in most patients on intermediate-term follow-up.

  14. Double stenting for malignant oesophago-respiratory fistula

    PubMed Central

    Kużdżał, Jarosław

    2016-01-01

    Introduction The close anatomical relationship between the oesophagus and bronchial tree results in formation of an oesophago-respiratory fistula in a subset of patients with advanced oesophageal or lung cancer. In those patients stenting of both the oesophagus and tracheobronchial tree is a valid option of palliative treatment. Aim To determine the effectiveness, tolerance, quality of life, safety and survival after double stenting procedures. Material and methods Retrospective analysis of a prospectively collected database was performed, concerning consecutive patients with oesophago-respiratory fistulas treated with double stenting. In all patients the degree of dysphagia, respiratory function before and after the procedure, and quality of life were evaluated. Partially covered oesophageal self-expanding metallic stents (PCESEMS) were used for oesophageal stenting, and silicone Y-type or partially covered self-expanding bronchial and tracheal stents (PCASEMS) were used to restore airway patency. Results Between 2003 and 2015, 31 patients underwent double stenting due to oesophago-respiratory fistulas. Twenty-nine patients were diagnosed with oesophageal squamous cell carcinoma and 2 with bronchial carcinoma. In all patients, improvement in the general condition and quality of life was observed after airway patency restoration. Two patients required mechanical ventilation due to respiratory failure immediately after the procedure. Seven patients with oesophageal fistulas died because of bleeding in the long-term follow-up. Four patients required endoscopic re-intervention. Mean survival time was 67.1 days. Conclusions Double stenting is an effective procedure improving patients’ quality of life. However, life-threatening complications can occur. PMID:27829946

  15. Towards a Better Corrosion Resistance and Biocompatibility Improvement of Nitinol Medical Devices

    NASA Astrophysics Data System (ADS)

    Rokicki, Ryszard; Hryniewicz, Tadeusz; Pulletikurthi, Chandan; Rokosz, Krzysztof; Munroe, Norman

    2015-04-01

    Haemocompatibility of Nitinol implantable devices and their corrosion resistance as well as resistance to fracture are very important features of advanced medical implants. The authors of the paper present some novel methods capable to improve Nitinol implantable devices to some marked degree beyond currently used electropolishing (EP) processes. Instead, a magnetoelectropolishing process should be advised. The polarization study shows that magnetoelectropolished Nitinol surface is more corrosion resistant than that obtained after a standard EP and has a unique ability to repassivate the surface. Currently used sterilization processes of Nitinol implantable devices can dramatically change physicochemical properties of medical device and by this influence its biocompatibility. The Authors' experimental results clearly show the way to improve biocompatibility of NiTi alloy surface. The final sodium hypochlorite treatment should replace currently used Nitinol implantable devices sterilization methods which rationale was also given in our previous study.

  16. An integrated semicompliant balloon ultrasound catheter for quantitative feedback and image guidance during stent deployment.

    PubMed

    Choi, Charles D; Savage, James; Stephens, Douglas N; O'Donnell, Matthew

    2005-09-01

    An integrated balloon ultrasound catheter prototype was designed to image from inside the balloon for real-time guidance during stent deployment. It was fabricated using a semicompliant balloon material (polyethylene) and a 20 MHz, 64-element circumferential ultrasound array. A commercial stent, nominally 4.4 mm in diameter and 12 mm in length, was used for a phantom study and placed along the length of the integrated balloon ultrasound catheter. A rubber phantom was created with an elastic modulus of 175 kPa with a 4.36 mm diameter lumen. Real-time balloon pressure measurements were recorded using a digital pressure sensor, and real-time radio-frequency (RF) data were captured as the balloon was inflated. The slope of the area-pressure ratio (APR) was compared to a reference measure of the balloon and stent expanded in water to determine a measure for optimal stent deployment. The results clearly indicate stent deployment at 11.1 atm using this metric. The APR slope could serve as quantitative feedback parameter for guiding stent deployment to reduce arterial injury and subsequent restenosis. After the stent deployment experiment, RF data were captured as the balloon catheter was moved along the length of the stent in pullback mode to confirm successful stent deployment. Ultimately, an integrated balloon ultrasound catheter could serve as a single catheter intervention device by providing real-time intravascular ultrasound (IVUS) imaging and quantitative feedback during stent deployment.

  17. Renal Artery Stent Outcomes

    PubMed Central

    Murphy, Timothy P.; Cooper, Christopher J.; Matsumoto, Alan H.; Cutlip, Donald E.; Pencina, Karol M.; Jamerson, Kenneth; Tuttle, Katherine R.; Shapiro, Joseph I.; D’Agostino, Ralph; Massaro, Joseph; Henrich, William; Dworkin, Lance D.

    2016-01-01

    BACKGROUND Multiple randomized clinical trials comparing renal artery stent placement plus medical therapy with medical therapy alone have not shown any benefit of stent placement. However, debate continues whether patients with extreme pressure gradients, stenosis severity, or baseline blood pressure benefit from stent revascularization. OBJECTIVES The study sought to test the hypothesis that pressure gradients, stenosis severity, and/or baseline blood pressure affects outcomes after renal artery stent placement. METHODS Using data from 947 patients with a history of hypertension or chronic kidney disease from the largest randomized trial of renal artery stent placement, the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, we performed exploratory analyses to determine if subsets of patients experienced better outcomes after stent placement than the overall cohort. We examined baseline stenosis severity, systolic blood pressure, and translesion pressure gradient (peak systolic and mean) and performed interaction tests and Cox proportional hazards analyses for the occurrence of the primary endpoint through all follow-up, to examine the effect of these variables on outcomes by treatment group. RESULTS There were no statistically significant differences in outcomes based on the examined variables nor were there any consistent nonsignificant trends. CONCLUSIONS Based on data from the CORAL randomized trial, there is no evidence of a significant treatment effect of the renal artery stent procedure compared with medical therapy alone based on stenosis severity, level of systolic blood pressure elevation, or according to the magnitude of the transstenotic pressure gradient. (Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions [CORAL]; NCT00081731) PMID:26653621

  18. Development of a dynamic in vitro model of a stented blood vessel to evaluate the effects of stent strut material selection and surface coating on smooth muscle cell response

    NASA Astrophysics Data System (ADS)

    Winn, Bradley Huegh

    formation of this new tissue, primarily consisting of VSMCs of the synthetic phenotype and their subsequent extracellular matrix, is the sole causation of in-stent restenosis since the stent serves to prevent elastic recoil and negative remodeling. This doctoral research program is focused on endovascular stent biomaterials science and engineering. Overall, this doctoral project is founded on the hypothesis that smooth muscle cell hyperplasia, as an important causative factor for vascular restenosis following endovascular stent deployment, is triggered by the various effects of stent strut contact on the vessel wall including contact forces and material biocompatibility. In this program, a dynamic in vitro model of a stented blood vessel aimed at evaluating the effect of stent strut material selection, and surface coating on smooth muscle cell response was developed. The in vitro stented artery model was validated through the proliferation of VSMC in contact with stent struts. Additionally, it was demonstrated that, with respect to known biocompatible materials such as Nitinol and 316L stainless steel, DNA synthesis and alpha-actin expression, as indicators of VSMC phenotype, are independent of stent material composition. Furthermore, hydroxyapatite was shown to be a biocompatible stent surface coating with acceptable post-strain integrity. This coating was shown in a feasibility study to be capable of serving as a favorable drug delivery platform able to reliably deliver locally therapeutic doses of bisphosphonates, such as alendronate, to control VSMC proliferation in an in vitro model of a stented blood vessel. This stent coating/drug combination may be effective for reducing restenosis as a result of VSMC hyperplasia in vivo.

  19. Paclitaxel or 5-fluorouracil/esophageal stent combinations as a novel approach for the treatment of esophageal cancer.

    PubMed

    Liu, Jieying; Wang, Zhongmin; Wu, Keqin; Li, Jing; Chen, Weiluan; Shen, Yuanyuan; Guo, Shengrong

    2015-01-01

    Currently, esophageal cancer is rarely curable, and herein, a paclitaxel or 5-fluorouracil/esophageal stent combination (PTX or 5-FU/stent) was used to provide a new approach to treat this cancer. The PTX or 5-FU/stent was prepared by covering a nitinol stent with a bilayered polymer film that consisted of a layer of 50% PTX or 5-FU and a layer of drug-free backing. These treatment modalities were evaluated in vivo after implantation into the porcine esophagus. The percentages of the drugs that permeated from the backing layer over a period of 95 days were very small (0.61% for 5-FU), and an overwhelming majority of the PTX and the 5-FU was released from the other side of the film. During the follow-up period (120 days), the drug/stent was always maintained in the porcine esophagus, and did not show any obvious systemic or local toxicities. In contrast, this treatment had an effect on the inhibition of tissue proliferation and ulceration. In addition, the drug concentrations were highest in the esophagus compared with in the heart, liver, spleen, lung, kidney and blood (81500.0 ± 9475.2 ng/g vs. 3.9 ± 0.3 ng/mL of PTX in the plasma at 13 days). The PTX/stent and the 5-FU/stent have a dual function as both a stent and a local drug delivery device, which provides a potential treatment modality with high efficacy and non systematic toxicity for esophageal cancer.

  20. Coronary Stent Infection Presented as Recurrent Stent Thrombosis

    PubMed Central

    Lai, Chih-Hung; Lin, Yung-Kai; Lee, Wen-Lieng

    2017-01-01

    Percutaneous transluminal coronary angioplasty with metal stent placement has become a well-developed treatment modality for coronary stenotic lesions. Although infection involving implanted stents is rare, it can, however, occur with high morbidity and mortality. We describe herein a case of an inserted coronary stent that was infected and complicated with recurrent stent thrombosis, pseudoaneurysm formation and severe sepsis. Despite repeated intervention and bypass surgery, the patient died from severe sepsis. PMID:28120580

  1. Nickel-associated delayed multiple white matter lesions after stent-assisted coil embolization of intracranial unruptured aneurysm.

    PubMed

    Park, Hun Soo; Nakagawa, Ichiro; Yokoyama, Shohei; Wajima, Daisuke; Wada, Takeshi; Motoyama, Yasushi; Kichikawa, Kimihiko; Nakase, Hiroyuki

    2017-02-20

    Metal-induced encephalopathy after stent-assisted coil embolization is extremely rare. The present report describes two patients who presented with symptomatic intracranial parenchymal edematous lesions after stent-assisted coil embolization. A 64-year-old woman underwent stent-assisted coil embolization for a left internal carotid artery aneurysm; 21 days after the procedure she presented with right hand weakness and MRI revealed multifocal white matter lesions. Another woman aged 52 years underwent stent-assisted coil embolization for right vertebral artery aneurysm; 18 days after the procedure she presented with left-sided sensory disturbance and MRI demonstrated multiple white matter lesions. Treatment in both cases resulted in improvement of these lesions after steroid pulse therapy, and the patients had no associated morbidity 4 months after the procedures. Clinicians should monitor for neurologic symptoms and postoperative delayed radiologic parenchymal edematous changes associated with the metal allergic reaction after nitinol stent-assisted coil embolization.

  2. Nickel-associated delayed multiple white matter lesions after stent-assisted coil embolization of intracranial unruptured aneurysm.

    PubMed

    Park, Hun Soo; Nakagawa, Ichiro; Yokoyama, Shohei; Wajima, Daisuke; Wada, Takeshi; Motoyama, Yasushi; Kichikawa, Kimihiko; Nakase, Hiroyuki

    2017-02-24

    Metal-induced encephalopathy after stent-assisted coil embolization is extremely rare. The present report describes two patients who presented with symptomatic intracranial parenchymal edematous lesions after stent-assisted coil embolization. A 64-year-old woman underwent stent-assisted coil embolization for a left internal carotid artery aneurysm; 21 days after the procedure she presented with right hand weakness and MRI revealed multifocal white matter lesions. Another woman aged 52 years underwent stent-assisted coil embolization for right vertebral artery aneurysm; 18 days after the procedure she presented with left-sided sensory disturbance and MRI demonstrated multiple white matter lesions. Treatment in both cases resulted in improvement of these lesions after steroid pulse therapy, and the patients had no associated morbidity 4 months after the procedures. Clinicians should monitor for neurologic symptoms and postoperative delayed radiologic parenchymal edematous changes associated with the metal allergic reaction after nitinol stent-assisted coil embolization.

  3. The location of obstruction predicts stent occlusion in malignant gastric outlet obstruction

    PubMed Central

    Grunwald, Douglas; Cohen, Jonah; Bartley, Anthony; Sheridan, Jennifer; Chuttani, Ram; Sawhney, Mandeep S.; Pleskow, Douglas K.; Berzin, Tyler M.; Mizrahi, Meir

    2016-01-01

    Background: Gastric outlet obstruction (GOO) can occur with locally invasive or metastatic cancer involving the upper gastrointestinal tract at the pylorus or the duodenum. Endoscopic management with self-expanding metal stents (SEMSs) is often the preferred palliative approach. Stent occlusion is a common reason for failure and reintervention. We set out to determine whether the location of the malignant obstruction is associated with the angulation of the stent and can predict stent occlusion. Methods: We performed a retrospective review of consecutive patients who underwent successful duodenal stenting with SEMS for malignant GOO between 2006 and 2015 at a large advanced endoscopy referral center. We determined the location of obstruction, the stent angle, and the rate of technical and clinical success of stent placement. We then identified cases of subsequent stent occlusion confirmed by endoscopic evaluation. Results: A total of 100 consecutive patients were included in the study; 91 of these patients had enough data to evaluate SEMS occlusion. A total of 21 patients (23%) developed stent occlusion with a median time of 39 days. The risk of occlusion sequentially increased as the obstruction occurred more distally from the antrum to the third or fourth portion of the duodenum (p = 0.006). This relationship was maintained after controlling for stent angle (p = 0.05). Conclusions: A distal location of malignant GOO was strongly predictive of stent occlusion, independent of stent angle. This may be due to longer and more complex distal obstructions, along with foreshortening of the stent during placement and tumor infiltration. If replicated, these results will have implications for endoscopic practice and future device development. PMID:27803736

  4. Evidence-Based Recommendations on Upper Gastrointestinal Tract Stenting: A Report from the Stent Study Group of the Korean Society of Gastrointestinal Endoscopy

    PubMed Central

    Jee, Sam Ryong; Kim, Kyung Ho; Kim, Sang Gyun; Cho, Jun-Hyung

    2013-01-01

    Endoscopic stents have evolved dramatically over the past 20 years. With the introduction of uncovered self-expanding metal stents in the early 1990s, they are primarily used to palliate symptoms of malignant obstruction in patients with inoperable gastrointestinal (GI) cancer. At present, stents have emerged as an effective, safe, and less invasive alternative for the treatment of malignant GI obstruction. Clinical decisions about stent placement should be made based on the exact understanding of the patient's condition. These recommendations based on a critical review of the available data and expert consensus are made for the purpose of providing endoscopists with information about stent placement. These can be helpful for management of patients with inoperable cancer or various nonmalignant conditions in the upper GI tract. PMID:23964331

  5. Postcatheterization Femoral Arteriovenous Fistulas: Endovascular Treatment with Stent-Grafts

    SciTech Connect

    Onal, Baran Kosar, Sule; Gumus, Terman; Ilgit, Erhan T.; Akpek, Sergin

    2004-09-15

    Purpose: To report our results of stent-graft implantation for the endovascular treatment of postcatheterization femoral arteriovenous fistulas (AVFs) occurring between the deep femoral artery and the femoral vein.Methods: Endovascular treatment of iatrogenic femoral AVFs as a result of arterial puncture for coronary angiography and/or angioplasty was attempted in 10 cases. Balloon-expandable stent-grafts, one for each lesion, were used to repair the fistulas, which were between the deep femoral artery and the femoral vein in all cases. Stent-graft implantation to the deep femoral artery was performed by a contralateral retrograde approach.Results: All stent-grafts were deployed successfully. Complete closure of the fistulas was accomplished immediately in nine of 10 cases. In one case, complete closure could not be obtained but the fact that the complaint subsided was taken to indicate clinical success. In three cases, side branch occlusion of the deep femoral artery occurred. No complications were observed after implantation. Follow-up for 8-31 months (mean 18.5 months) with color Doppler ultrasonography revealed patency of the stented arterial segments without recurrent arteriovenous shunting in those nine patients who had successful immediate closure of their AVFs.Conclusion: Our results with a mean follow-up 18.5 months suggest that stent-graft implantation for the closure of postcatheterization femoral AVFs originating from the deep femoral artery is an effective, minimally invasive alternative procedure.

  6. [Mechanical analysis on a new type of biodegradable magnesium-alloy stent].

    PubMed

    Wang, Xiaoping; Cui, Fuzhai; Li, Jianguo; Zhao, Xingshan

    2009-04-01

    Biodegradable magnesium-alloy stents have been employed in animal experiments and clinical researches in recent years. Magnesium-alloy stents have been reported to be biocompatible, and degradable due to corrosion after being implanted into blood vessel. However, magnesium alloy is brittle compared with stainless steel. This may cause strut break under large deformation. In this paper, a finite element model of magnesium-alloy stent was set up, with reference to pictures from Biotronik Corporation, to simulate the expanding and bending processes. The results of analysis show that the maximum strain during expanding reaches 20%, being greater than the elongation limit of the commercially available magnesium alloys. Therefore, to avoid strut breakage during expanding, the magnesium alloys should be custom-made. The plasticity of the material should be improved by grain refinement processes before practicable magnesium-alloy stents could be developed.

  7. Corrosion behaviour of Nitinol alloy coated with alkylsilanes and polypyrrole.

    PubMed

    Flamini, D O; Saidman, S B

    2014-11-01

    Nitinol (equiatomic Ni and Ti alloy (NiTi)) substrate was modified using a coating system formed by a self-assembled film of alkylsilane compounds (propyltrichlorosilane (C3H7SiCl3) or octadecyltrichlorosilane (C18H37SiCl3)) and polypyrrole (PPy) doped with sodium bis(2-ethylhexyl) sulfosuccinate (Aerosol OT or AOT). The combination of alkylsilanes and the presence of a voluminous molecule like AOT entrapped into the PPy films improve the pitting corrosion resistance of the substrate in chloride solution. The best performance was achieved with the longest alkylsilane chains, where the PPy film remains adhered to the underlying coating after a pitting corrosion test.

  8. The Influence of Microcleanliness on the Fatigue Performance of Nitinol

    NASA Astrophysics Data System (ADS)

    Kumar, Parikshith K.; Lasley, Christopher

    2014-07-01

    The presence of carbide and oxide inclusions in nitinol, and their influence on the fatigue performance, has been an important consideration in the medical device community. Microcleanliness, as determined by inclusion size and inclusion density, has often been cited as a potential factor influencing the fatigue behavior of the material. However, no comprehensive study has been conducted to determine their impacts on the fatigue behavior. The objective of this effort was to understand the influence of the inclusions present in the material on the fatigue behavior.

  9. Battery actuation of NITINOL at sub-zero temperatures

    NASA Astrophysics Data System (ADS)

    Goldstein, David

    1989-04-01

    It is feasible to use batteries to produce rapid shape memory response in NITINOL wires which are in sub-zero temperature ambients. Data are presented on lithium thionyl chloride batteries used to joule heat 10 mil diameter wires of nominal transformation temperatures of 90 to 105 C. The batteries and wires were jointly tested in a -35 C ambient air environment. The wire contracted 5 percent in length (0.4 inch) and lifted a 1 pound load in 1/2 second.

  10. Effects of Stresses on the Phase Transformation of NITINOL

    DTIC Science & Technology

    1986-04-02

    in a strip cold-rolled as much as 16.7%. The authors did not discuss the source of the hardening in this particular test. At 550’C, the alloy i...internal stresses than if slowly cooled. Gilfrich,5 3 based on the metallography of a hot-rolled strip , concluded that TiNi structures with more than...G. F., and Barrett, R. D., "An Evaluation of Cobalt-Substituted Nitinol Wire in Orthodontics ," American Journal of Orthodontics , Vol. 63, No. 5, May

  11. Palliative Treatment of Malignant Colorectal Strictures with Metallic Stents

    SciTech Connect

    Paul Diaz, Laura; Pinto Pabon, Isabel; Fernandez Lobato, Rosa; Montes Lopez, Carmen

    1999-01-15

    Purpose: To assess the effectiveness and safety of self-expanding metallic stents as a primary palliative treatment for inoperable malignant colorectal strictures. Methods: Under radiological guidance 20 self-expanding metallic Wallstents were implanted in 16 consecutive patients with colorectal stenoses caused by malignant neoplasms, when surgical treatment of the condition had been ruled out. The patients were followed up clinically for 1-44 months, until death or termination of this study. Results: The stents were successfully implanted in all cases and resolved the clinical obstruction in all the patients except one, who underwent subsequent colostomy. During follow-up of the remaining 15 patients, clinical complications arising from the procedure were pain (two patients), minor rectal bleeding (one patient), and severe rectal bleeding (one patient) (26%). There were three cases of stent migration and three cases of stent occlusion, and reintervention by us was necessary in 20% of cases (3/15). The mean life span following the procedure was 130 days, and none of the patients exhibited clinical symptoms of obstruction at the time of death (12 patients) or termination of the study (3 patients). Conclusion: Deployment of metallic stents under radiologic guidance is an effective alternative as a primary palliative measure in malignant colorectal obstruction, though the possible clinical complications and need for repeat intervention during follow-up should be taken into account.

  12. A Source Manual for Information on NITINOL and NiTi

    DTIC Science & Technology

    1978-02-13

    NSWC/WOL TR 78-26/ A SOURCE MANUAL FOR INFORMATION ON <z NITINOL AND NiTi BY DAVID GOLDSTEIN RESEARCH AND TECHNOLOGY DEPARTMENT 13 FEBRUARY 1978 C...Conthinua owevess, side it necessary and identity by bWeck ammmber) NITINOL Nickel-Titanium Alloys NiTi Shape Memory Effect Heat Engines W0. A WRACT...Conshnue an reverse Wde Ifftoeseat and Identify by Weoek nmmer) This manual is a current listing of most of the published literature on NITINOL and NiTi

  13. A numerical study on the application of the functionally graded materials in the stent design.

    PubMed

    Khosravi, Arezoo; Bahreinizad, Hossein; Bani, Milad Salimi; Karimi, Alireza

    2017-04-01

    Undesirable deformation of the stent can induce a significant amount of injure not only to the blood vessel but also to the plaque. The objective of this study was to reduce/minimize these undesirable deformations by the application of Functionally Graded Materials (FGM). To do this, Finite Element (FE) method was employed to simulate the expansion of a stent and the corresponding displacement of the stenosis plaque. Three hyperelastic plaque types as well as five elastoplastic stents were simulated. Dogboning, foreshortening, maximum stress in the plaque, and the pressure which is needed to fully expand the stent for different stent materials, were acquired. While all FGMs had lower dogboning in comparison to the stents made of the uniform materials, the stent with the lowest heterogeneous index displayed the lowest amount of dogboning. Steel stent showed the lowest foreshortening and fully expansion pressure but the difference was much lower than that the one for dogboning. Therefore, the FGM with the heterogeneous index of 0.5 is expected to exhibit the most suitable results. In addition, the results revealed that the material parameters has crucial effects on the deformation of the stent and, as a result, as a design point of view the FGM parameters can be tailored to achieve the goal of the biomechanical optimization.

  14. [Stents in iliac vascular changes].

    PubMed

    Gross-Fengels, W; Friedmann, G; Fischbach, R; Erasmi, H; Bulling, B

    1991-01-01

    The results of 79 iliac stent placements in 64 patients are reported. The technical success rate was 96%. The systolic pressure gradient dropped from 44 mmHg before to 2.8 mmHg after stent placement. This differed significantly as compared to a group treated by conventional PTA (gradient 5.8 mmHg). The cumulative patency after 18-20 months was 90%. Angiographic controls up to 19 months after "stenting" demonstrated only one secondary stent occlusion. Iliac stents therefore are a very valuable supplement to classic PTA.

  15. Customized covered stent graft for percutaneous closure of Fontan baffle leak.

    PubMed

    Binder, Ronald K; Nietlispach, Fabian; Carere, Ronald G

    2013-05-01

    We report the innovation of both a partly-covered and completely-covered, variable-diameter, balloon-expandable stent that was custom-designed by NuMed, Inc for percutaneous closure of a baffle leak after total caval pulmonary connection (TCPC). A 50-year-old patient, born with tricuspid atresia, who had undergone TCPC, developed severe persistent cyanosis due to a right-to-left shunt through a TCPC baffle leak. Re-operation was deemed too high risk. Therefore, considering his complex anatomy, a custom-made, partly-covered, tapered, balloon-expandable stent was designed and successfully deployed. Months later, the shunt recurred at the junction of the covered to uncovered stent cells; subsequently, a second fully-covered, custom-made, tapered stent was implanted with an excellent outcome. The use of covered or partly-covered customized variable-diameter stents for closure of baffle leak after TCPC is feasible and resulted in marked clinical improvement. Customized balloon-expandable stents may be superior to traditional cylindrical stents because of better anchoring and apposition.

  16. Antiplatelet therapy in patients undergoing coronary stenting

    PubMed Central

    ten Berg, J.M.; van Werkum, J.W.; Heestermans, A.A.C.M.; Jaarsma, W.; Hautvast, R.M.A.; den Heijer, P.; de Boer, M.J.

    2006-01-01

    Background Anticoagulation after coronary stenting is essential to prevent stent thrombosis. Drug-eluting stents, which are the preferred therapy, may be associated with a higher tendency for stent thrombosis. Methods Patients who underwent coronary stent placement and presented with late stent thrombosis are described. Results Eight patients with stent thrombosis are presented. Early discontinuation of the antithrombotic medication is associated with the occurrence of these complications. Conclusion Long-term antithrombotic therapy seems essential to prevent stent thrombosis, especially for patients treated with drug-eluting stents. PMID:25696663

  17. Collagen Matrix Remodeling in Stented Pulmonary Arteries after Transapical Heart Valve Replacement.

    PubMed

    Ghazanfari, Samaneh; Driessen-Mol, Anita; Hoerstrup, Simon P; Baaijens, Frank P T; Bouten, Carlijn V C

    2016-01-01

    The use of valved stents for minimally invasive replacement of semilunar heart valves is expected to change the extracellular matrix and mechanical function of the native artery and may thus impair long-term functionality of the implant. Here we investigate the impact of the stent on matrix remodeling of the pulmonary artery in a sheep model, focusing on matrix composition and collagen (re)orientation of the host tissue. Ovine native pulmonary arteries were harvested 8 (n = 2), 16 (n = 4) and 24 (n = 2) weeks after transapical implantation of self-expandable stented heart valves. Second harmonic generation (SHG) microscopy was used to assess the collagen (re)orientation of fresh tissue samples. The collagen and elastin content was quantified using biochemical assays. SHG microscopy revealed regional differences in collagen organization in all explants. In the adventitial layer of the arterial wall far distal to the stent (considered as the control tissue), we observed wavy collagen fibers oriented in the circumferential direction. These circumferential fibers were more straightened in the adventitial layer located behind the stent. On the luminal side of the wall behind the stent, collagen fibers were aligned along the stent struts and randomly oriented between the struts. Immediately distal to the stent, however, fibers on both the luminal and the adventitial side of the wall were oriented in the axial direction, demonstrating the stent impact on the collagen structure of surrounding arterial tissues. Collagen orientation patterns did not change with implantation time, and biochemical analyses showed no changes in the trend of collagen and elastin content with implantation time or location of the vascular wall. We hypothesize that the collagen fibers on the adventitial side of the arterial wall and behind the stent straighten in response to the arterial stretch caused by oversizing of the stent. However, the collagen organization on the luminal side suggests that

  18. Experimental Study of Poly-l-Lactic Acid Biodegradable Stents in Normal Canine Bile Ducts

    SciTech Connect

    Yamamoto, Kiyosei Yoshioka, Tetsuya; Furuichi, Kinya; Sakaguchi, Hiroshi; Anai, Hiroshi; Tanaka, Toshihiro; Morimoto, Kengo; Uchida, Hideo; Kichikawa, Kimihiko

    2011-06-15

    Purpose: This study was designed to clarify the advantages of biodegradable stents in terms of mucosal reaction and biodegradation after placement. We designed a biodegradable stent and assessed stent degradation and changes in the normal bile ducts of dogs. Methods: The biodegradable stent is a balloon-expandable Z stent consisting of poly-l-lactic acid (PLLA) with a diameter of 6 mm and a length of 15 mm. We assessed four groups of three beagle dogs each at 1, 3, 6, and 9 months of follow-up. After evaluating stent migration by radiography and stent and bile duct patency by cholangiography, the dogs were sacrificed to remove the bile duct together with the stent. The bile duct lumen was examined macroscopically and histologically, and the stent degradation was examined macroscopically and by scanning electron microscopy (SEM). Results: Bile duct obstruction was absent and none of the stents migrated. Macroscopic evaluation showed moderate endothelial proliferation in the bile ducts at the implant sites at 3 and 6 months and a slight change at 9 months. Slight mononuclear cell infiltration was histologically identified at all time points and epithelial hyperplasia that was moderate at 3 months was reduced to slight at 6 and 9 months. Stent degradation was macroscopically evident in all animals at 9 months and was proven by SEM in two dogs at 6 months and in all of them at 9 months. Conclusions: Our results suggest that PLLA bioabsorbable stents seems to be useful for implantation in the biliary system with further investigation.

  19. Collagen Matrix Remodeling in Stented Pulmonary Arteries after Transapical Heart Valve Replacement

    PubMed Central

    Ghazanfari, Samaneh; Driessen-Mol, Anita; Hoerstrup, Simon P.; Baaijens, Frank P.T.; Bouten, Carlijn V.C.

    2016-01-01

    The use of valved stents for minimally invasive replacement of semilunar heart valves is expected to change the extracellular matrix and mechanical function of the native artery and may thus impair long-term functionality of the implant. Here we investigate the impact of the stent on matrix remodeling of the pulmonary artery in a sheep model, focusing on matrix composition and collagen (re)orientation of the host tissue. Ovine native pulmonary arteries were harvested 8 (n = 2), 16 (n = 4) and 24 (n = 2) weeks after transapical implantation of self-expandable stented heart valves. Second harmonic generation (SHG) microscopy was used to assess the collagen (re)orientation of fresh tissue samples. The collagen and elastin content was quantified using biochemical assays. SHG microscopy revealed regional differences in collagen organization in all explants. In the adventitial layer of the arterial wall far distal to the stent (considered as the control tissue), we observed wavy collagen fibers oriented in the circumferential direction. These circumferential fibers were more straightened in the adventitial layer located behind the stent. On the luminal side of the wall behind the stent, collagen fibers were aligned along the stent struts and randomly oriented between the struts. Immediately distal to the stent, however, fibers on both the luminal and the adventitial side of the wall were oriented in the axial direction, demonstrating the stent impact on the collagen structure of surrounding arterial tissues. Collagen orientation patterns did not change with implantation time, and biochemical analyses showed no changes in the trend of collagen and elastin content with implantation time or location of the vascular wall. We hypothesize that the collagen fibers on the adventitial side of the arterial wall and behind the stent straighten in response to the arterial stretch caused by oversizing of the stent. However, the collagen organization on the luminal side suggests that

  20. Monitorizing nitinol alloy surface reactions for biofouling studies

    NASA Astrophysics Data System (ADS)

    Dinu, C. Z.; Dinca, V. C.; Soare, S.; Moldovan, A.; Smarandache, D.; Scarisoareanu, N.; Barbalat, A.; Birjega, R.; Dinescu, M.; DiStefano, V. Ferrari

    2007-07-01

    Growth and deposition of unwanted bacteria on implant metal alloys affect their use as biomedical samples. Monitoring any bacterial biofilm accumulation will provide early countermeasures. For a reliable antifouling strategy we prepared nitinol (NiTi) thin films on Ti-derived substrates by using a pulsed laser deposition (PLD) method. As the microstructure of Ti-alloy is dictated by the tensile strength, fatigue and the fracture toughness we tested the use of hydrogen as an alloying element. X-ray diffraction (XRD), scanning electron microscopy (SEM) and atomic force microscopy (AFM) investigated the crystalline structure, chemical composition and respectively the surface morphology of the nitinol hydrogen and hydrogen-free samples. Moreover, the alloys were integrated and tested using a cellular metric and their responses were systematic evaluated and quantified. Our attractive approach is meant to select the suitable components for an effective and trustworthy anti-fouling strategy. A greater understanding of such processes should lead to novel and effective control methods that would improve in the future implant stability and capabilities.

  1. Heterogeneous Intravascular Ultrasound Findings of Stent Thrombosis

    PubMed Central

    Morofuji, Toru; Inaba, Shinji; Aisu, Hiroe; Takahashi, Kayo; Saito, Makoto; Higashi, Haruhiko; Yoshii, Toyofumi; Sumimoto, Takumi

    2017-01-01

    Objective The underlying mechanisms of stent thrombosis are not completely understood. Methods We experienced 12 definite stent thrombosis cases (1 early, 1 late, and 10 very late) at our hospital from July 2011 to April 2016 and evaluated the possible causes of stent thrombosis by intravascular ultrasound (IVUS). Results Five different potential morphological causes of stent thrombosis (neoatherosclerosis, stent malapposition, stent fracture, edge dissection, and stent underexpansion) were detected by IVUS in 10 cases (83.3%); in 1 of the remaining 2 cases, the discontinuation of antithrombotic drugs resulted in early stent thrombosis without abnormal IVUS findings. Of the 12 stent thrombosis cases, 4 occurred at a bare-metal stent (average time from stent implantation, 106 months); in all 12, significant neointimal hyperplasia was observed on IVUS, and 2 had plaque ruptures at an in-stent or proximal reference. Malapposed stent struts were observed in three very-late stent thromboses, and all of these underwent sirolimus-eluting stent implantation. Stent thrombosis due to mechanical (stent fracture) or procedure-related complications (edge dissection and stent underexpansion) was observed in three cases. Conclusion In patients with stent thrombosis, heterogeneous findings were observed in IVUS. This IVUS case series illustrates the possible mechanisms of stent thrombosis. PMID:28154268

  2. Overlap stenting for in-stent restenosis after carotid artery stenting

    PubMed Central

    Nishihori, Masahiro; Ohshima, Tomotaka; Yamamoto, Taiki; Goto, Shunsaku; Nishizawa, Toshihisa; Shimato, Shinji; Izumi, Takashi; Kato, Kyozo

    2016-01-01

    ABSTRACT Our aim was to assess the clinical safety and efficacy of overlap stenting for in-stent restenosis after carotid artery stenting. The study was conducted between July 2008 and February 2015. A database of consecutive carotid artery stenting procedures was retrospectively assessed to identify the cases of in-stent restenosis that were treated with overlap stenting under proximal or distal protection. The clinical and radiological records of the patients were then reviewed. Of the 155 CAS procedures in 149 patients from the database, 6 patients met the inclusion criteria. All the 6 patients were initially treated with moderate dilatation because of the presence of an unstable plaque. The technical success rate of the overlap stenting was 100%, with no 30-day mortality or morbidity. In addition, there was no further in-stent restenosis during a follow-up period of over 12 months. These results indicated that overlap stenting for in-stent restenosis after carotid artery stenting was both safe and effective in our cohort. PMID:27303101

  3. Influence of microstructural purity on the bending fatigue behavior of VAR-melted superelastic Nitinol.

    PubMed

    Launey, Maximilien; Robertson, Scott W; Vien, Lot; Senthilnathan, Karthikeyan; Chintapalli, Prashanth; Pelton, Alan R

    2014-06-01

    The bending fatigue resistance of commercially-available Standard versus High Purity Nitinol was evaluated at 3% mean strain and a range of strain amplitudes with the simple wire Z-specimen geometry. The Standard grade Nitinol demonstrated a 10(7)-cycle fatigue strain limit of 0.50% alternating strain, comparable to results reported elsewhere in the literature. Conversely, the High Purity grade VAR Nitinol demonstrated a 5-fold improvement in fatigue resistance with an impressive 10(7)-cycle fatigue strain limit of 2.5% alternating strain. The High Purity Nitinol has an oxygen+nitrogen content of 60wppm, maximum wrought-material inclusion length of 17µm, and inclusion volume fraction of 0.28%, all substantially less than industry standards. With all processing variables held constant except for inclusion content, it is clear that this marked fatigue superiority is due exclusively to the reduction in both size and area fraction of inclusions.

  4. Fatigue of Nitinol: The state-of-the-art and ongoing challenges.

    PubMed

    Mahtabi, M J; Shamsaei, Nima; Mitchell, M R

    2015-10-01

    Nitinol, a nearly equiatomic alloy of nickel and titanium, has been considered for a wide range of applications including medical and dental devices and implants as well as aerospace and automotive components and structures. The realistic loading condition in many of these applications is cyclic; therefore, fatigue is often the main failure mode for such components and structures. The fatigue behavior of Nitinol involves many more complexities compared with traditional metal alloys arising from its uniqueness in material properties such as superelasticity and shape memory effects. In this paper, a review of the present state-of-the-art on the fatigue behavior of superelastic Nitinol is presented. Various aspects of fatigue of Nitinol are discussed and microstructural effects are explained. Effects of material preparation and testing conditions are also reviewed. Finally, several conclusions are made and recommendations for future works are offered.

  5. [The investigation of nickel dissolution from nitinol under different extraction conditions in biological tests].

    PubMed

    Wen, Xiantao; He, Xueying; Li, Jian; Tang, Juli; Huang, Yongfu

    2013-03-01

    The dissolution of nickel from nitinol alloy under different extraction conditions was investigated when biological tests of nitinol medical devices were carried out. It discussed the equivalence of these extraction conditions and found the best extraction conditions. In the experiment, two brands of nitinol were chosen and extracted under different extraction conditions according to GB/T 16886-12. Plasma emission spectrometer was used to analyse the concentration of nickel in extract liquid. The results show that there is no equivalence among these extraction conditions for nitinol materials. And it is suggested that (37 +/- 1) degree C, (72 +/- 2) h could be used as normal extraction condition and (70 +/- 2) degrees C, (24 +/- 2) h as accelerated extraction condition.

  6. Coronary covered stents.

    PubMed

    Kilic, Ismail Dogu; Fabris, Enrico; Serdoz, Roberta; Caiazzo, Gianluca; Foin, Nicolas; Abou-Sherif, Sara; Di Mario, Carlo

    2016-11-20

    Covered stents offer an effective bail-out strategy in vessel perforations, are an alternative to surgery for the exclusion of coronary aneurysms, and have a potential role in the treatment of friable embolisation-prone plaques. The aim of this manuscript is to offer an overview of currently available platforms and to report results obtained in prior studies.

  7. Effects of Thermomechanical History on the Tensile Behavior of Nitinol Ribbon

    NASA Technical Reports Server (NTRS)

    Lach, Cynthia L.; Turner, Travis L.; Taminger, Karen M.; Shenoy, Ravi N.

    2002-01-01

    Shape memory alloys (SMAs) have enormous potential for a wide variety of applications. A large body of work exists on the characterization of the microstructure and stress-strain behavior of these alloys, Nitinol (NiTi) in particular. However, many attributes of these materials are yet to be fully understood. Previous work at NASA Langley Research Center (LaRC) has included fabrication of hybrid composite specimens with embedded Nitinol actuators and modeling of their thermomechanical behavior. An intensive characterization effort has been undertaken to facilitate fundamental understanding of this alloy and to promote implementation of Nitinol in aerospace applications. Previous work revealed attributes of the Nitinol ribbon that were not easily rationalized with existing data in the literature. In particular, tensile behavior at ambient temperature showed significant dependence on the thermomechanical history prior to testing. The present work is focused on characterizing differences in the microstructure of Nitinol ribbons exposed to four different thermomechanical histories and correlation of the microstructure with tensile properties. Differential scanning calorimetry (DSC) and x-ray diffraction (XRD) analysis were employed to rationalize the microstructures present after exposure to various thermomechanical histories. Three of the Nitinol ribbon conditions were reversible upon heating (in the DSC) through the reverse transformation temperature (A(sub f) to transform the microstructure to austenite. However, the prior thermomechanical conditioning for the Nitinol ribbon that reflected the entire fabrication procedure (4% thermal cycle condition) was found to have an irreversible effect on the microstructure, as it remained unchanged after repeated complete thermal cycles. Tensile tests were conducted to determine the effect of prior thermomechancal conditioning on both the tensile behavior of the Nitinol ribbons and the stress state of the microstructure. The

  8. Endovascular Management of Chronic Type B Dissecting Aortic Aneurysm Utilizing Aortic and Renal Stents

    SciTech Connect

    Taylor, J. D. Dunckley, M.; Thompson, M.; Morgan, R. A.

    2008-07-15

    Over the last 10 years endovascular stent-graft placement has been increasingly used to treat complicated acute Type B thoracic aortic dissections. While studies have demonstrated the use of additional aortic stent-grafts to treat continued false lumen perfusion and case reports have detailed the use of renal artery stents to treat renal ischemia related to aortic dissection, to our knowledge the adjuvant use of renal artery stents to reduce false lumen perfusion has not been reported. We present the case of a 72-year-old male who had previously undergone endovascular repair of a complicated Type B thoracic aortic dissection and presented with an expanding false lumen in the peridiaphragmatic aorta despite coverage of the entire thoracic aorta. This was treated by closure of a right renal fenestration using a renal stent.

  9. Erosion of esophageal stent into left main bronchus causing airway compromise

    PubMed Central

    Aneeshkumar, S; Sundararajan, L; Santosham, Rajan; Palaniappan, Rajkumar; Dhus, Ubal

    2017-01-01

    Covered or uncovered self-expanding metal stents are currently used for the palliative treatment of neoplastic esophageal strictures or compressions and esophageal leaks or fistulas due to malignancies. Erosion of esophageal stents into the respiratory tract is a rare complication and that too has been reported mostly as an early complication within few days or weeks. Here, we present the case of a 31-year-old female, who presented with a late complication of an esophageal stent eroding into the left main bronchus causing respiratory distress. She was stented for a benign corrosive esophageal stricture following caustic soda ingestion 3 years ago. She underwent a thoracotomy and closure of esophagobronchial fistula along with laparoscopic esophagectomy and gastric pull through. Postoperatively, patient developed an anastomotic leak which was corrected by placing a temporary stent. PMID:28144066

  10. Endovascular Exclusion of Visceral Artery Aneurysms with Stent-Grafts: Technique and Long-Term Follow-up

    SciTech Connect

    Rossi, Michele; Rebonato, Alberto Greco, Laura; Citone, Michele; David, Vincenzo

    2008-01-15

    This paper describes four cases of visceral artery aneurysms (VAAs) successfully treated with endovascular stent-grafts and discusses the endovascular approach to VAAs and the long-term results. Four balloon expandable stent-grafts were used to treat three splenic artery aneurysms and one bleeding common hepatic artery pseudoaneurysm. The percutaneous access site and the materials were chosen on the basis of CT angiography findings. In all cases the aneurysms were successfully excluded. In one case a splenic infarction occurred, with nonrelevant clinical findings. At 16- to 24-month follow-up three patients had patent stents and complete exclusion and shrinkage of the aneurysms. One patient died due to pancreatitis and sepsis, 16 days after successful stenting and exclusion of a bleeding pseudoaneurysm. We conclude that endovascular treatment using covered stent-grafts is a valid therapeutic option for VAAs. Multislice CT preoperative study helps in planning stent-graft positioning.

  11. PALMAZ stent in the treatment of peripheral arterial disease

    NASA Astrophysics Data System (ADS)

    Henry, Michel; Amor, Max; Ethevenot, Gerard; Henry, Isabelle; Amicabile, Claude; Beron, Richard; Mentre, Bernard; Allaoui, Mohamed

    1994-02-01

    To overcome problems associated with angioplasty, placement of a balloon-expandable vascular prosthesis was studied. Two hundred sixty-eight patients had a stent or stents implanted for reasons of restenosis, occlusion or dissection. One hundred forty-eight patients presented with iliac lesions, 108 with femoro-popliteal lesions and 12 patients had lesions within bypass grafts. Patients were followed up for an average of 19.89 months with angiographic, Doppler ultrasound and clinical evaluation. Only five cases of restenosis were not able to be corrected by secondary angioplasty. The primary patency rate at 3 years for iliac stents was 91%, and for femoropopliteal lesions was 72%. Secondary patency rates did not differ appreciable for femoropopliteal and iliac lesions and for stenoses and occlusions.

  12. Protective constriction of coronary vein grafts with knitted nitinol

    PubMed Central

    Moodley, Loven; Franz, Thomas; Human, Paul; Wolf, Michael F.; Bezuidenhout, Deon; Scherman, Jacques; Zilla, Peter

    2013-01-01

    OBJECTIVES Different flow patterns and shear forces were shown to cause significantly more luminal narrowing and neointimal tissue proliferation in coronary than in infrainguinal vein grafts. As constrictive external mesh support of vein grafts led to the complete suppression of intimal hyperplasia (IH) in infrainguinal grafts, we investigated whether mesh constriction is equally effective in the coronary position. METHODS Eighteen senescent Chacma baboons (28.8 ± 3.6 kg) received aorto-coronary bypass grafts to the left anterior descending artery (LAD). Three groups of saphenous vein grafts were compared: untreated controls (CO); fibrin sealant-sprayed controls (CO + FS) and nitinol mesh-constricted grafts (ME + FS). Meshes consisted of pulse-compliant, knitted nitinol (eight needles; 50 μm wire thickness; 3.4 mm resting inner diameter, ID) spray attached to the vein grafts with FS. After 180 days of implantation, luminal dimensions and IH were analysed using post-explant angiography and macroscopic and histological image analysis. RESULTS At implantation, the calibre mismatch between control grafts and the LAD expressed as cross-sectional quotient (Qc) was pronounced [Qc = 0.21 ± 0.07 (CO) and 0.18 ± 0.05 (CO + FS)]. Mesh constriction resulted in a 29 ± 7% reduction of the outer diameter of the vein grafts from 5.23 ± 0.51 to 3.68 ± 0 mm, significantly reducing the calibre discrepancy to a Qc of 0.41 ± 0.17 (P < 0.02). After 6 months of implantation, explant angiography showed distinct luminal irregularities in control grafts (ID difference between widest and narrowest segment 74 ± 45%), while diameter variations were mild in mesh-constricted grafts. In all control grafts, thick neointimal tissue was present [600 ± 63 μm (CO); 627 ± 204 μm (CO + FS)] as opposed to thin, eccentric layers of 249 ± 83 μm in mesh-constricted grafts (ME + FS; P < 0.002). The total wall thickness had increased by 363 ± 39% (P < 0.00001) in CO and 312 ± 61% (P < 0

  13. Geometry parameterization and multidisciplinary constrained optimization of coronary stents.

    PubMed

    Pant, Sanjay; Bressloff, Neil W; Limbert, Georges

    2012-01-01

    Coronary stents are tubular type scaffolds that are deployed, using an inflatable balloon on a catheter, most commonly to recover the lumen size of narrowed (diseased) arterial segments. A common differentiating factor between the numerous stents used in clinical practice today is their geometric design. An ideal stent should have high radial strength to provide good arterial support post-expansion, have high flexibility for easy manoeuvrability during deployment, cause minimal injury to the artery when being expanded and, for drug eluting stents, should provide adequate drug in the arterial tissue. Often, with any stent design, these objectives are in competition such that improvement in one objective is a result of trade-off in others. This study proposes a technique to parameterize stent geometry, by varying the shape of circumferential rings and the links, and assess performance by modelling the processes of balloon expansion and drug diffusion. Finite element analysis is used to expand each stent (through balloon inflation) into contact with a representative diseased coronary artery model, followed by a drug release simulation. Also, a separate model is constructed to measure stent flexibility. Since the computational simulation time for each design is very high (approximately 24 h), a Gaussian process modelling approach is used to analyse the design space corresponding to the proposed parameterization. Four objectives to assess recoil, stress distribution, drug distribution and flexibility are set up to perform optimization studies. In particular, single objective constrained optimization problems are set up to improve the design relative to the baseline geometry-i.e. to improve one objective without compromising the others. Improvements of 8, 6 and 15% are obtained individually for stress, drug and flexibility metrics, respectively. The relative influence of the design features on each objective is quantified in terms of main effects, thereby suggesting the

  14. Development of a New Hanging-Type Esophageal Stent for Preventing Migration: A Preliminary Study in an Animal Model of Esophagotracheal Fistula

    SciTech Connect

    Endo, Masayuki Kaminou, Toshio Ohuchi, Yasufumi; Sugiura, Kimihiko; Yata, Shinsaku Adachi, Akira Kawai, Tsuyoshi Takasugi, Syohei Yamamoto, Shuichi Matsumoto, Kensuke; Hashimoto, Masayuki; Ihaya, Takashi; Ogawa, Toshihide

    2012-10-15

    Purpose: Covered, self-expandable metallic stents (SEMS) have been enthusiastically adopted for the treatment of esophagotracheal fistula, but problems with stent migration have yet to be resolved. To overcome this problem, we have developed a new hanging-type esophageal stent designed to prevent migration, and we conducted an animal study to assess the efficacy of our method. Methods: A total of six female pigs were used in this study. The main characteristic of our stent was the presence of a string tied to the proximal edge of the stent for fixation under the skin of the neck. The first experiment was performed to confirm technical feasibility in three pigs with esophagotracheal fistula. The second experiment was performed to evaluate stent migration and esophagotracheal fistula in three pigs. Results: Creation of the esophagotracheal fistula and stent placement were technically successful in all pigs. In the first experiment, esophagotracheal fistula was sealed by stent placement. In the second experiment, no stent migration was seen 11 or 12 days after stent placement. Gross findings showed no fistulas on the esophageal or tracheal wall. Conclusions: Our new hanging-type esophageal stent seems to offer a feasible method for preventing stent migration.

  15. Delayed complications after flow-diverter stenting: reactive in-stent stenosis and creeping stents.

    PubMed

    Cohen, José E; Gomori, John Moshe; Moscovici, Samuel; Leker, Ronen R; Itshayek, Eyal

    2014-07-01

    We assessed the frequency and severity of changes in stent configuration and location after the treatment of intracranial aneurysms, and patterns of in-stent stenosis. We retrospectively reviewed data for consecutive aneurysm patients managed with endovascular implantation of flow-diverter stents (Silk Flow Diverter [Balt Extrusion, Montmorency, France] and Pipeline Embolization Device [ev3/Coviden, Minneapolis, MN, USA]) from October 2011 to July 2012. Routine 2, 6, 9-12, and 16-20 month follow-up angiograms were compared, with a focus on changes in stent configuration and location from immediately after deployment to angiographic follow-up, and the incidence and development of in-stent stenosis. Thirty-four patients with 42 aneurysms met inclusion criteria. The Silk device was implanted in 16 patients (47%, single device in 15), the Pipeline device in 18 (53%, single device in 16). On first follow-up angiography, in-stent stenosis was observed in 38% of Silk devices and 39% of Pipeline devices. In-stent stenosis was asymptomatic in 12 of 13 patients. One woman presented with transient ischemic attacks and required stent angioplasty due to end tapering and mild, diffuse in-stent stenosis. Configuration and location changes, including stent creeping and end tapering were seen in 2/16 patients (13%) with Silk devices, and 0/18 patients with Pipeline devices. We describe stent creeping and end tapering as unusual findings with the potential for delayed clinical complications. In-stent stenosis, with a unique behavior, is a frequent angiographic finding observed after flow-diverter stent implant. The stenosis is usually asymptomatic; however, close clinical and angiographic monitoring is mandatory for individualized management.

  16. Wave reflection at a stent.

    PubMed

    Crespo, Antonio; García, Javier; Manuel, Fernando

    2013-01-01

    A simple analytical expression has been derived to calculate the characteristics of a wave that reflects at a stent implanted in a uniform vessel. The stent is characterized by its length and the wave velocity in the stented region. The reflected wave is proportional to the time derivative of the incident wave. The reflection coefficient is a small quantity of the order of the length of the stent divided by the wavelength of the unstented vessel. The results obtained coincide with those obtained numerically by Charonko et al. The main simplifications used are small amplitude of the waves so that equations can be linearized and that the length of the stent is small enough so that the values of the wave functions are nearly uniform along the stent. Both assumptions hold in typical situations.

  17. [Stent Grafting for Aortic Dissection].

    PubMed

    Uchida, Naomichi

    2016-07-01

    The purpose of stent graft for aortic dissection is to terminate antegrade blood flow into the false lumen through primary entry. Early intervention for primary entry makes excellent aortic remodeling and emergent stent grafting for complicated acute type B aortic dissection is supported as a class I. On the other hand stent grafting for chronic aortic dissection is controversial. Early stent grafting is considered with in 6 months after on-set if the diameter of the descending aorta is more than 40 mm. Additional interventions for residual false lumen on the downstream aorta are still required. Stent graft for re-entry, candy-plug technique, and double stenting, other effective re-interventions were reported. Best treatment on the basis of each anatomical and physical characteristics should be selected in each institution. Frozen elephant trunk is alternative procedure for aortic dissection without the need to take account of proximal anatomical limitation and effective for acute type A aortic dissection.

  18. Effect of heat treatment temperature on nitinol wire

    NASA Astrophysics Data System (ADS)

    Cai, S.; Schaffer, J. E.; Daymond, M. R.; Yu, C.; Ren, Y.

    2014-08-01

    In-situ synchrotron X-ray diffraction has been used to study the influence of the heat treatment temperature on the subsequent micromechanical behavior of nitinol wire. It was found that increase in the heat treatment temperature rotated the austenite texture from the {332}B2 fiber towards the {111}B2 fiber, and the texture of the Stress-Induced Martensite phase changed from the ( 1 ¯ 40)B19' to the ( 1 ¯ 20)B19' fiber accordingly. Heat treatment at a low temperature reduces the internal residual strains in the austenite during super-elastic deformation and therefore improves the materials fatigue performance. The development of internal residual strains in austenite is controlled by transformation induced plasticity and the reversal martensite to austenite transformation.

  19. Charpy Impact Energy and Microindentation Hardness of 60-NITINOL

    NASA Technical Reports Server (NTRS)

    Stanford, Malcolm K.

    2012-01-01

    60-NITINOL (60 wt.% Ni 40 wt.% Ti) is being studied as a material for advanced aerospace components. The Charpy impact energy and microindentation hardness has been studied for this material, fabricated by vacuum induction skull melting (casting) and by hot isostatic pressing. Test specimens were prepared in various hardened and annealed heat treatment conditions. The average impact energy ranged from 0.33 to 0.49J for the hardened specimens while the annealed specimens had impact energies ranging from 0.89 to 1.18J. The average hardness values of the hardened specimens ranged from 590 to 676 HV while that of the annealed specimens ranged from 298 to 366 HV, suggesting an inverse relationship between impact energy and hardness. These results are expected to provide guidance in the selection of heat treatment processes for the design of mechanical components.

  20. Temporary endoscopic metallic stent for idiopathic esophageal achalasia.

    PubMed

    Coppola, Franco; Gaia, Silvia; Rolle, Emanuela; Recchia, Serafino

    2014-02-01

    Idiopathic achalasia is a motor disorder of the esophagus of unknown etiology caused by loss of motor neurons determining an altered motility. It may determine severe symptoms such as progressive dysphagia, regurgitations, and pulmonary aspirations. Many therapeutic options may be offered to patients with achalasia, from surgery to endoscopic treatments such as pneumatic dilation, botulinum injection, peroral endoscopic myotomy, or endoscopic stenting. Recently, temporary placement of a stent was proposed by Cheng as therapy for achalasia disorders, whereas no Western authors have dealt with it up to date. The present study reports our preliminary experience in 7 patients with achalasia treated with a temporary stent. Partially covered self-expanding metallic stents (Micro-Tech, Nanjin, China) 80 mm long and 30 mm wide were placed under fluoroscopic control and removed after 6 days. Clinical follow-up was scheduled to check endoscopic success, symptoms release, and complications. The placement and the removal of the stents were obtained in all patients without complications. Mean clinical follow-up was 19 months. Five out of 7 patients referred total symptoms release and 2 experienced significant improvement of dysphagia. The procedure was not time consuming and was safe; no mild or severe complications were registered. In conclusion, our results may suggest a possible safe and effective endoscopic alternative treatment in patients with achalasia; however, further larger studies are necessary to confirm these promising, but very preliminary, data.

  1. Analysis of risk factors associated with complications of colonic stenting for malignant obstruction.

    PubMed

    Dindar, Gokhan; Ustundag, Yucel; Karakan, Tarkan

    2014-07-21

    Self expanding metalic stent (SEMS) application can cause serious problems up to one third of the patients and some studies reported negative effect of SEMSs on survival in patients with malignancy. The SEMS type especially the rigid one like Wall-stent rather than more flexible type Ultraflex was also reported to have bad impact on the risk of perforation we believe that stent based management protocol for patients with non-perforating left sided obstructing colorectal cancer is a complex method that needs qualified medical and technical team.

  2. Analysis of risk factors associated with complications of colonic stenting for malignant obstruction

    PubMed Central

    Dindar, Gokhan; Ustundag, Yucel; Karakan, Tarkan

    2014-01-01

    Self expanding metalic stent (SEMS) application can cause serious problems up to one third of the patients and some studies reported negative effect of SEMSs on survival in patients with malignancy. The SEMS type especially the rigid one like Wall-stent rather than more flexible type Ultraflex was also reported to have bad impact on the risk of perforation we believe that stent based management protocol for patients with non-perforating left sided obstructing colorectal cancer is a complex method that needs qualified medical and technical team. PMID:25083098

  3. Stent graft exclusion of a pseudoaneurysm in a Blalock-Taussig shunt.

    PubMed

    Sanchez-Recalde, Angel; Garzón, Gonzalo; Oliver, José M

    2010-08-01

    This case is the first report of slow-growing pseudoaneurysm after vessel dissection secondary to two stents implantation into classic Blalock Taussig shunt in a patient with pulmonary atresia and ventricular septal defect. Pseudoaneurysm was successfully excluded by a percutaneous approach with self-expandable stent graft deployment from the aorta to the middle of the Blalock Taussig shunt. Nearly 3 years after the procedure, the classic BT is patent, and there were no restenosis or thrombosis in spite of the very long length of the stented segment.

  4. Percutaneous Placement of Permanent Metallic Stents in the Cystic Duct to Treat Obstructive Cholecystitis.

    PubMed

    Brown, Nicholas I; Jhamb, Ashu; Brooks, Duncan M; Little, Andrew F

    2015-12-01

    This report presents a series of five patients unsuitable for surgery who had nonretrievable self-expanding metallic stents deployed along the cystic duct as treatment for benign and malignant causes of gallbladder obstruction. Techniques are described for draining cholecystitis, removing gallstones, bypassing gallbladder obstructions, and inserting metallic stents across the cystic duct to restore permanent antegrade gallbladder drainage in acute and chronic cholecystitis. Symptoms resolved in all cases, and stents remained patent for as long as 22 months. This procedure may be an effective alternative to cholecystectomy or long-term gallbladder drainage for patients in inoperable condition.

  5. Limitations of Endovascular Treatment with Stent-Grafts for Active Mycotic Thoracic Aortic Aneurysm

    SciTech Connect

    Ishida, Masaki; Kato, Noriyuki; Hirano, Tadanori; Shimono, Takatsugu; Yasuda, Fuyuhiko; Tanaka, Kuniyoshi; Yada, Isao; Takeda, Kan

    2002-06-15

    An 81-year-old woman with ruptured mycotic thoracic aortic aneurysm was treated with endovascular placement of stent-grafts fabricated from expanded polytetrafluoroethylene and Z-stents. Although exclusion of the aneurysm was achieved at the end of the procedure, a type I endoleak developed on the following day.Despite emergent surgical resection of the aneurysm and extra-anatomical reconstruction, the patient died 2 days later. Stent-graft repair may not be a suitable method for the treatment of ruptured mycotic aneurysm in the presence of active infection.

  6. An analysis of the contact between the stent and the artery using tube hydroforming simulation.

    PubMed

    Araújo, Rogério; Guimarães, Tobias A; Oliveira, Sônia A G

    2013-11-01

    Stents for angioplasty have been extensively used to treat coronary diseases. The aim of this study is to analyze the expansion of the stent and the contact with the artery using tube hydroforming simulation. In the simulation, the contact stress and the final shape of the artery after stent expansion process using the Stampack (®;) software will be studied. A model of a commercial stent made of 316L stainless steel was modeled by using an elastic-plastic constitutive law with isotropic hardening. The artery was modeled as a cylinder and made of hyperelastic material. The stent model studied in this work presented a good performance according to the results obtained. After expansion, any region of the stent's structure with strong risk of wrinkling, thinning, or buckling was not observed. In the forming limit diagram, all points were far from the Keeler-Goodwin diagram. Furthermore, the expanded stent model has a good conformability. In conclusion, our data show that the proposed methodology is a useful tool to check if the stent model implanted in the artery may cause restenosis after angioplasty; thus, our tests provided a reliable tool to analyze this risk.

  7. Treatment of Pelvic Venous Spur (May-Thurner Syndrome) with Self-Expanding Metallic Endoprostheses

    SciTech Connect

    Binkert, Christoph A.; Schoch, Eric; Stuckmann, Gerd; Largiader, Jon; Wigger, Pius; Schoepke, Wolfdietrich; Zollikofer, Christoph L.

    1998-01-15

    Purpose: The application of self-expanding metallic endoprostheses (stents) to treat symptomatic pelvic venous spurs as an alternative to surgery. Methods: Wallstents with a diameter from 14 to 16 mm and one Cragg stent were placed in the left common iliac vein of eight patients (seven women, one man; mean age 42 years) with a symptomatic pelvic venous spur (left deep venous thrombosis or post-thrombotic leg swelling). Four patients had surgical thrombectomy prior to stent placement. Results: Technical success with immediate reduction of left leg circumference was achieved in all eight patients. A primary patency rate of 100% was observed during an average follow-up of 3 years (range 10-121 months). There were no procedural or stent-related complications. Conclusion: The percutaneous transfemoral placement of self-expanding metallic stents is an effective minimally invasive alternative to surgery in the treatment of symptomatic pelvic venous spur.

  8. Nasal packing and stenting

    PubMed Central

    Weber, Rainer K.

    2011-01-01

    Nasal packs are indispensable in ENT practice. This study reviews current indications, effectiveness and risks of nasal packs and stents. In endoscopic surgery, nasal packs should always have smooth surfaces to minimize mucosal damage, improve wound healing and increase patient comfort. Functional endoscopic endonasal sinus surgery allows the use of modern nasal packs, since pressure is no longer required. So called hemostatic/resorbable materials are a first step in this direction. However, they may lead to adhesions and foreign body reactions in mucosal membranes. Simple occlusion is an effective method for creating a moist milieu for improved wound healing and avoiding dryness. Stenting of the frontal sinus is recommended if surgery fails to produce a wide, physiologically shaped drainage path that is sufficiently covered by intact tissue. PMID:22073095

  9. Covered versus bare stents for transjugular intrahepatic portosystemic shunt: an updated meta-analysis of randomized controlled trials

    PubMed Central

    Qi, Xingshun; Tian, Yulong; Zhang, Wei; Yang, Zhiping; Guo, Xiaozhong

    2016-01-01

    Background: Transjugular intrahepatic portosystemic shunt (TIPS) is a standard treatment option for the management of portal hypertension in liver cirrhosis. Since the introduction of covered stents, shunt patency has been greatly improved. However, it remains uncertain about whether covered stents could improve survival. A meta-analysis of randomized controlled trials has been performed to compare the outcomes of covered versus bare stents for TIPS. Methods: PubMed, EMBASE, and Cochrane Library databases were searched to identify the relevant randomized controlled trials. Overall survival, shunt patency, and hepatic encephalopathy were the major endpoints. Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was calculated. Cochrane risk of bias tool was employed. Results: Overall, 119 papers were identified. Among them, four randomized controlled trials were eligible. Viatorr covered stents alone, Fluency covered stents alone, and Viatorr plus Fluency covered stents were employed in one, two, and one randomized controlled trials, respectively. Risk of bias was relatively low. Meta-analyses demonstrated that the covered-stents group had significantly higher probabilities of overall survival (HR = 0.67, 95% CI = 0.50–0.90, p = 0.008) and shunt patency (HR = 0.42, 95% CI = 0.29–0.62, p < 0.0001) than the bare-stents group. Additionally, the covered-stents group might have a lower risk of hepatic encephalopathy than the bare-stents group (HR = 0.70, 95% CI = 0.49–1.00, p = 0.05). The heterogeneity among studies was not statistically significant in the meta-analyses. Conclusions: Compared with bare stents, covered stents for TIPS may improve the overall survival. In the era of covered stents, the indications for TIPS may be further expanded. PMID:28286557

  10. iStent® Trabecular Microbypass Stent: An Update

    PubMed Central

    Resende, Arthur Fernandes; Patel, Neal Sanjay; Waisbourd, Michael; Katz, L. Jay

    2016-01-01

    Due to the high rates of complications and failure experienced with current glaucoma procedures, there is a continuous search for a safer and more effective glaucoma surgery. A new class of procedures termed minimally invasive glaucoma surgeries (MIGS) aim to fill this void by offering an alternative method of IOP reduction associated with markedly reduced complication rates and shorter recovery times. The iStent, a trabecular microbypass stent, is a MIGS device that has quickly gained popularity. The device allows aqueous humor to directly drain from the anterior chamber into Schlemm's canal by bypassing an obstructed trabecular meshwork. This review examines publications about the iStent, focusing on the device's efficacy, safety, and cost when a single iStent or multiple iStents are implanted in combination with cataract surgery or as a solo procedure. Current data suggest that the iStent is a safe and effective tool in the management of mild-to-moderate glaucoma, notable for its limited complications and absence of serious adverse events following implantation. As valuable experience is gained performing ab interno MIGS, increasing familiarity with angle anatomy and iStent placement, and as newer stent designs are developed, there is promise of continual improvement in the surgical management of glaucoma. PMID:27413541

  11. Critical overview of Nitinol surfaces and their modifications for medical applications

    SciTech Connect

    Shabalovskaya, S.; Anderegg, J.; Van Humbeeck, J.

    2008-02-06

    Nitinol, a group of nearly equiatomic shape memory and superelastic NiTi alloys, is being extensively explored for medical applications. Release of Ni in the human body, a potential problem with Nitinol implant devices, has stimulated a great deal of research on its surface modifications and coatings. In order to use any of the developed surfaces in implant designs, it is important to understand whether they really have advantages over bare Nitinol. This paper overviews the current situation, discusses the advantages and disadvantages of new surfaces as well as the limitations of the studies performed. It presents a comprehensive analysis of surface topography, chemistry, corrosion behavior, nickel release and biological responses to Nitinol surfaces modified mechanically or using such methods as etching in acids and alkaline solutions, electropolishing, heat and ion beam treatments, boiling in water and autoclaving, conventional and ion plasma implantations, laser melting and bioactive coating deposition. The analysis demonstrates that the presently developed surfaces vary in thickness from a few nanometers to micrometers, and that they can effectively prevent Ni release if the surface integrity is maintained under strain and if no Ni-enriched sub-layers are present. Whether it is appropriate to use various low temperature pre-treatment protocols ({le} 160 C) developed originally for pure titanium for Nitinol surface modifications and coatings is also discussed. The importance of selection of original Nitinol surfaces with regard to the performance of coatings and comparative performance of controls in the studies is emphasized. Considering the obvious advantages of bare Nitinol surfaces for superelastic implants, details of their preparation are also outlined.

  12. Heparin-Coated Coronary Stents.

    PubMed

    van Der Giessen WJ; van Beusekom HM; Larsson; Serruys

    1999-09-01

    The development of the heparin-coated (HC)-stent should be viewed against the backdrop of the early unfavorable results with noncoated stents in the pre-intravascular ultrasound and pre-ticlopidine era. Notwithstanding, results of pilot and randomized trials show a surprisingly low incidence of (sub)acute stent thrombosis under challenging circumstances, such as acute coronary syndromes. Considering the quite low incidence of early complications with noncoated second-generation stents, it may require large trials to prove the clinical efficacy of the heparin- coating against noncoated devices. However, even if the "added value" of the heparin-coating will never be clinically proven, it has helped to enhance the penetration of stent therapy in interventional cardiology. Unlike the situation in 1992, very few cardiologists will now disagree with the statement that stents contribute to the state-of-the-art treatment of patients with angina pectoris or acute myocardial infarction. A preliminary comparison of available trials also suggests that the heparin-coated Palmaz-Schatz stent (Cordis Corp., Waterloo, Belgium) is as effective as the noncoated stent plus abciximab treatment.

  13. Endoscopic stenting for hilar cholangiocarcinoma: efficacy of unilateral and bilateral placement of plastic and metal stents in a retrospective review of 480 patients

    PubMed Central

    2012-01-01

    Background Endoscopic biliary drainage of hilar cholangiocarcinoma is controversial with respect to the optimal types of stents and the extent of drainage. This study evaluated endoscopic palliation in patients with hilar cholangiocarcinoma using self-expandable metallic stents (SEMS) and plastic stents (PS).We also compared unilateral and bilateral stent placement according to the Bismuth classification. Methods Data on 480 patients receiving endoscopic biliary drainage for hilar cholangiocarcinoma between September 1995 and December 2010 were retrospectively reviewed to evaluate the following outcome parameters: technical success (TS), functional success (FS), early and late complications, stent patency and survival. Patients were followed from stent insertion until death or stent occlusion. Patients were divided into 3 groups according to the Bismuth classification (Group 1, type I; Group 2, type II; Group 3, type > III). Results The initial stent insertion was successful in 450 (93.8%) patients. TS was achieved in 204 (88.3%) patients treated with PS and in 246 (98.8%) patients palliated with SEMS (p < 0.001). In the intention-to-treat (ITT) analysis, the FS in patients treated with SEMS (97.9%) was significantly higher than in patients treated with PS (84.8%) (p < 0.001). Late complications occurred in 115 (56.4%) patients treated with PS and 60 (24.4%) patients treated with SEMS (p < 0.001). The median duration of stent patency in weeks (w) were as follows: 20 w in patients palliated with PS and 27 w in patients treated with SEMS (p < 0.0001). In Group 2, the median duration of PS patency was 17 w and 18 w for unilateral and bilateral placement, respectively (p = 0.0004); the median duration of SEMS patency was 24 w and 29 w for unilateral and bilateral placement, respectively (p < 0.0001). Multivariate analysis using the Poisson regression showed that SEMS placement (B = 0.48; P < 0.01) and bilateral deployment (B = 0

  14. Are Aortic Stent Grafts Safe in Pregnancy?

    PubMed Central

    Khandanpour, Nader; Mehta, Tapan A.; Adiseshiah, M.; Meyer, Felicity J.

    2015-01-01

    Aortic stent grafts are increasingly used to treat aortic aneurysms and also other aortic pathologies. The safety of aortic stent grafts in pregnancy has never been studied or reported. We report on two cases of aortic stent grafts in pregnant women and discuss the effect of pregnancy on these aortic stent grafts. PMID:26229702

  15. Fretting corrosion behavior of nitinol spinal rods in conjunction with titanium pedicle screws.

    PubMed

    Lukina, Elena; Kollerov, Mikhail; Meswania, Jay; Khon, Alla; Panin, Pavel; Blunn, Gordon W

    2017-03-01

    Untypical corrosion damage including erosions combined with the build-up of titanium oxide as a corrosion product on the surface of explanted Nitinol spinal rods in the areas where it was in contact with titanium pedicle screw head is reported. It was suggested that Nitinol rods might have inferior fretting corrosion resistance compared with that made of titanium or CoCr. Fretting corrosion of Nitinol spinal rods with titanium (Ti6Al4V) pedicle screws were tested in-vitro by conducting a series of potentiostatic measurements of the peak-to-peak values of fretting corrosion current under bending in a 10% solution of calf serum in PBS. The test included Nitinol rods locked in titanium pedicle screws of different designs. Performance of commercially available titanium (Ti6Al4V) and CoCr spinal rods was also investigated for a comparison. Corrosion damage observed after the in-vitro tests was studied using SEM and EDAX analysis and was compared with patterns on Nitinol rods retrieved 12months after initial surgery. Metal ions level was measured in the test media after in-vitro experiments and in the blood and tissues of the patients who had the rods explanted. The results of this study revealed that Nitinol spinal rods locked in Ti pedicle screws are susceptible to fretting corrosion demonstrating higher fretting corrosion current compared with commercially used Ti6Al4V and CoCr rods. On the surface of Nitinol rods after in-vitro tests and on those retrieved from the patients similar corrosion patterns were observed. Improved resistance to fretting corrosion was observed with Nitinol rods in the in-vitro tests where pedicle screws were used with a stiffer locking mechanism. Since the development of the localized corrosion damage might increase the risk of premature fatigue failure of the rods and result in leaching of Ni ions, it is concluded that Nitinol rods should not be used in conjunction with Ti pedicle screws without special protection especially where the

  16. Developments in metallic biodegradable stents.

    PubMed

    Hermawan, H; Dubé, D; Mantovani, D

    2010-05-01

    Interest in metallic degradable biomaterials research has been growing in the last decade. Both scientific journals and patent databases record a high increase in publications in this area. Biomedical implants with temporary function, such as coronary stents, are the targeted applications for this novel class of biomaterials. It is expected that stents made of degradable biomaterials, named biodegradable stents, will provide a temporary opening into a narrowed arterial vessel until the vessel remodels and will progressively disappear thereafter. Biodegradable stents made of metal have recently been progressed into preclinical tests in humans after their first introduction in early 2000s. By referring to patents and journal publications, this paper reviews the developments in biodegradable stents, with emphasis on those made of metals, starting from the first design ideas to validation testing.

  17. A Review of Similar and Dissimilar Micro-joining of Nitinol

    NASA Astrophysics Data System (ADS)

    Deepan Bharathi Kannan, T.; Ramesh, T.; Sathiya, P.

    2016-04-01

    NiTinol belongs to a class of smart materials which has a wide range of applications in the field of automotive, aerospace, biomedical, robotics, etc., owing to the growing trend in miniaturization of components. Micro-joining is becoming one of the important and familiar processes in the fabrication of miniaturized components. Recently, effective micro-joining of thin sheets has been gaining a lot of interest among researchers. In this article, the research and progress in micro-joining of NiTinol to itself and other metals are reviewed at different aspects. To date, laser welding, tungsten inert gas welding, and resistance welding have been used to a large extent in investigating the weldability of NiTinol alloys. Some important welding parameters used in micro joining by various researchers and their effects on weld qualities are detailed in this review. Metallurgical aspects, mechanical properties and corrosion aspects of micro-joined NiTinol sheets/wires are discussed. The aim of this report is to review the recent progress in micro-joining of NiTinol and to provide a basis for follow-on research.

  18. Adhesion, vitality and osteogenic differentiation capacity of adipose derived stem cells seeded on nitinol nanoparticle coatings.

    PubMed

    Strauss, Sarah; Neumeister, Anne; Barcikowski, Stephan; Kracht, Dietmar; Kuhbier, Jörn W; Radtke, Christine; Reimers, Kerstin; Vogt, Peter M

    2013-01-01

    Autologous cells can be used for a bioactivation of osteoimplants to enhance osseointegration. In this regard, adipose derived stem cells (ASCs) offer interesting perspectives in implantology because they are fast and easy to isolate. However, not all materials licensed for bone implants are equally suited for cell adhesion. Surface modifications are under investigation to promote cytocompatibility and cell growth. The presented study focused on influences of a Nitinol-nanoparticle coating on ASCs. Possible toxic effects as well as influences on the osteogenic differentiation potential of ASCs were evaluated by viability assays, scanning electron microscopy, immunofluorescence and alizarin red staining. It was previously shown that Nitinol-nanoparticles exert no cell toxic effects to ASCs either in soluble form or as surface coating. Here we could demonstrate that a Nitinol-nanoparticle surface coating enhances cell adherence and growth on Nitinol-surfaces. No negative influence on the osteogenic differentiation was observed. Nitinol-nanoparticle coatings offer new possibilities in implantology research regarding bioactivation by autologous ASCs, respectively enhancement of surface attraction to cells.

  19. Adhesion, Vitality and Osteogenic Differentiation Capacity of Adipose Derived Stem Cells Seeded on Nitinol Nanoparticle Coatings

    PubMed Central

    Strauß, Sarah; Neumeister, Anne; Barcikowski, Stephan; Kracht, Dietmar; Kuhbier, Jörn W.; Radtke, Christine; Reimers, Kerstin; Vogt, Peter M.

    2013-01-01

    Autologous cells can be used for a bioactivation of osteoimplants to enhance osseointegration. In this regard, adipose derived stem cells (ASCs) offer interesting perspectives in implantology because they are fast and easy to isolate. However, not all materials licensed for bone implants are equally suited for cell adhesion. Surface modifications are under investigation to promote cytocompatibility and cell growth. The presented study focused on influences of a Nitinol-nanoparticle coating on ASCs. Possible toxic effects as well as influences on the osteogenic differentiation potential of ASCs were evaluated by viability assays, scanning electron microscopy, immunofluorescence and alizarin red staining. It was previously shown that Nitinol-nanoparticles exert no cell toxic effects to ASCs either in soluble form or as surface coating. Here we could demonstrate that a Nitinol-nanoparticle surface coating enhances cell adherence and growth on Nitinol-surfaces. No negative influence on the osteogenic differentiation was observed. Nitinol-nanoparticle coatings offer new possibilities in implantology research regarding bioactivation by autologous ASCs, respectively enhancement of surface attraction to cells. PMID:23308190

  20. Ureteral stents: new ideas, new designs

    PubMed Central

    Al-Aown, Abdulrahman; Kyriazis, Iason; Kallidonis, Panagiotis; Kraniotis, Pantelis; Rigopoulos, Christos; Karnabatidis, Dimitrios; Petsas, Theodore; Liatsikos, Evangelos

    2010-01-01

    Ureteral stents represent a minimally invasive alternative to preserve urinary drainage whenever ureteral patency is deteriorated or is under a significant risk to be occluded due to extrinsic or intrinsic etiologies. The ideal stent that would combine perfect long-term efficacy with no stent-related morbidity is still lacking and stent usage is associated with several adverse effects that limit its value as a tool for long-term urinary drainage. Several new ideas on stent design, composition material and stent coating currently under evaluation, foreseen to eliminate the aforementioned drawbacks of ureteral stent usage. In this article we review the currently applied novel ideas and new designs of ureteral stents. Moreover, we evaluate potential future prospects of ureteral stent development adopted mostly by the pioneering cardiovascular stent industry, focusing, however, on the differences between ureteral and endothelial tissue. PMID:21789086

  1. External-to-Internal Iliac Stent-Graft: Medium-Term Patency Following Exclusion of a Retrogradely Perfused Common Iliac Aneurysm

    SciTech Connect

    Nicholls, Marcus John; McPherson, Simon

    2010-08-15

    Following complicated aortic aneurysm surgery a complete left iliac occlusion resulted in buttock claudication. A retrogradely perfused right common iliac aneurysm expanded. Exclusion was by external-to-internal iliac stent-graft. No deterioration in claudication occurred with medium-term stent-graft patency.

  2. Plastic biliary stents for malignant biliary diseases.

    PubMed

    Huibregtse, Inge; Fockens, Paul

    2011-07-01

    Plastic biliary endoprostheses have not changed much since their introduction more than 3 decades ago. Although their use has been challenged by the introduction of metal stents, plastic stents still remain commonly used. Much work has been done to improve the problem of stent obstruction but without substantial clinical success. In this review, the authors discuss the history of plastic biliary stent development and the current use of plastic stents for malignant biliary diseases.

  3. Nitinol thermoreactive clips for secondary sternal closure in cases of noninfective sternal dehiscence.

    PubMed

    Gucu, Arif; Toktas, Faruk; Eris, Cuneyt; Ata, Yusuf; Turk, Tamer

    2012-01-01

    Postoperative sternal dehiscence is a potentially catastrophic sequela to median sternotomy that can cause not only chest-wall discomfort and pulmonary dysfunction but infection, both superficial and mediastinal. Nitinol thermoreactive clips use a novel material in the treatment of sternal dehiscence. We sought to determine whether the use of these clips is an effective remedy for noninfective sternal dehiscence. From January 2008 through December 2011, we retrospectively studied the data on 10 patients whose sternums had been closed with nitinol thermoreactive clips after the development of noninfective sternal dehiscence. Diagnosis was made on the bases of clinical criteria, chest radiography, and microbiological investigation. There was no control group. No procedure-related sequelae occurred. There was no recurrent sternal instability and dehiscence, sternal-related hemorrhage, superficial wound infection, or mediastinal infection. We believe that the use of nitinol thermoreactive clips is a safe, easy, and efficient method of secondary sternal closure for noninfective sternal dehiscence.

  4. Electronic structure of nitinol surfaces oxidized by low-energy ion bombardment

    SciTech Connect

    Petravic, M. Varasanec, M.; Peter, R.; Kavre, I.; Metikos-Hukovic, M.; Yang, Y.-W.

    2014-06-28

    We have studied the electronic structure of nitinol exposed to low-energy oxygen-ion bombardment, using x-ray photoemission spectroscopy (XPS) and near-edge x-ray absorption fine structure (NEXAFS) spectroscopy. XPS spectra reveal a gradual transformation of nitinol surfaces into TiO{sub 2} with increased dose of implanted oxygen. No oxidation of Ni atoms has been detected. NEXAFS spectra around O K-edge and Ti L{sub 2,3}-edge, reflecting the element-specific partial density of empty electronic states, exhibit features, which can be attributed to the creation of molecular orbitals, crystal field splitting, and the absence of long-range order, characteristic of the amorphous TiO{sub 2}. Based on these results, we discuss the oxidation kinetics of nitinol under low-energy oxygen-ion bombardment.

  5. Electronic structure of nitinol surfaces oxidized by low-energy ion bombardment

    NASA Astrophysics Data System (ADS)

    Petravic, M.; Varasanec, M.; Peter, R.; Kavre, I.; Metikos-Hukovic, M.; Yang, Y.-W.

    2014-06-01

    We have studied the electronic structure of nitinol exposed to low-energy oxygen-ion bombardment, using x-ray photoemission spectroscopy (XPS) and near-edge x-ray absorption fine structure (NEXAFS) spectroscopy. XPS spectra reveal a gradual transformation of nitinol surfaces into TiO2 with increased dose of implanted oxygen. No oxidation of Ni atoms has been detected. NEXAFS spectra around O K-edge and Ti L2,3-edge, reflecting the element-specific partial density of empty electronic states, exhibit features, which can be attributed to the creation of molecular orbitals, crystal field splitting, and the absence of long-range order, characteristic of the amorphous TiO2. Based on these results, we discuss the oxidation kinetics of nitinol under low-energy oxygen-ion bombardment.

  6. Laser shape setting of superelastic nitinol wires: Functional properties and microstructure

    NASA Astrophysics Data System (ADS)

    Tuissi, Ausonio; Coduri, Mauro; Biffi, Carlo Alberto

    Shape setting is one of the most important steps in the production route of Nitinol Shape Memory Alloys (SMAs), as it can fix the functional properties, such as the shape memory effect and the superelasticity (SE). The conventional method for making the shape setting is performed at 400-500∘C in furnaces. In this work, a laser beam was adopted for performing straight shape setting on commercially available austenitic Nitinol thin wires. The laser beam, at different power levels, was moved along the wire length for inducing the functional performances. Calorimetric, pseudo-elastic and microstructural features of the laser annealed wires were studied through differential scanning calorimetry, tensile testing and high energy X-ray diffraction, respectively. It can be stated that the laser technology can induce SE in thin Nitinol wires: the wire performances can be modulated in function of the laser power and improved functional properties can be obtained.

  7. Endoscopic ultrasonography-guided placement of a transhepatic portal vein stent in a live porcine model

    PubMed Central

    Park, Tae Young; Seo, Dong Wan; Kang, Hyeon-Ji; Cho, Min Keun; Song, Tae Jun; Park, Do Hyun; Lee, Sang Soo; Lee, Sung Koo; Kim, Myung-Hwan

    2016-01-01

    Background and Objectives: Percutaneous portal vein (PV) stent placement is used to manage PV occlusion or stenosis caused by malignancy. The use of endoscopic ultrasonography (EUS) has expanded to include vascular interventions. The aim of this study was to examine the technical feasibility and safety of EUS-guided transhepatic PV stent placement in a live porcine model. Materials and Methods: EUS-guided transhepatic PV stent placement was performed in six male miniature pigs under general anesthesia using forward-viewing echoendoscope. Under EUS guidance, the left intrahepatic PV was punctured with a 19-gauge fine-needle aspiration (FNA) needle and a 0.025 inch guidewire inserted through the needle and into the main PV. The FNA needle was then withdrawn and a needle-knife inserted to dilate the tract. Under EUS and fluoroscopic guidance, a noncovered metal stent was inserted over the guidewire and released into the main PV. Results: A PV stent was placed successfully in all six pigs with no technical problems or complications. The patency of the stent in the main PV was confirmed using color Doppler EUS and transhepatic portal venography. Necropsy of the first three animals revealed no evidence of bleeding and damage to intra-abdominal organs or vessels. No complications occurred in the remaining three animals during the 8 weeks observation period. Conclusions: EUS-guided transhepatic PV stent placement can be both technically feasible and safe in a live animal model. PMID:27803904

  8. Materials and Manufacturing Technologies Available for Production of a Pediatric Bioabsorbable Stent

    PubMed Central

    Alexy, Ryan D.; Levi, Daniel S.

    2013-01-01

    Transcatheter treatment of children with congenital heart disease such as coarctation of the aorta and pulmonary artery stenosis currently involves the use of metal stents. While these provide good short term results, there are long term complications with their use. Children outgrow metal stents, obligating them to future transcatheter dilations and eventual surgical removal. A bioabsorbable stent, or a stent that goes away with time, would solve this problem. Bioabsorbable stents are being developed for use in coronary arteries, however these are too small for use in pediatric congenital heart disease. A bioabsorbable stent for use in pediatric congenital heart disease needs to be low profile, expandable to a diameter 8 mm, provide sufficient radial strength, and absorb quickly enough to allow vessel growth. Development of absorbable coronary stents has led to a great understanding of the available production techniques and materials such as bioabsorbable polymers and biocorrodable metals. Children with congenital heart disease will hopefully soon benefit from the current generation of bioabsorbable and biocorrodable materials and devices. PMID:24089660

  9. Mechanical properties and biocompatibility of plasma-nitrided laser-cut 316L cardiovascular stents.

    PubMed

    Arslan, Erdem; Iğdil, Mustafa C; Yazici, Hilal; Tamerler, Candan; Bermek, Hakan; Trabzon, Levent

    2008-05-01

    The effect of surface modification of laser-cut 316L cardiovascular stents by low-T plasma nitriding was evaluated in terms of mechanical properties and biocompatibility of the stents. The plasma nitriding was performed at 400, 450 or 500 degrees C using various ratios of nitrogen-hydrogen gas mixtures. The flexibility and radial strength were measured in crimped and expanded state of the stents, respectively. The mechanical properties could be adjusted and improved by plasma nitriding conducted at temperatures lower than 450 degrees C and/or nitrogen content less than 10% in the treatment gas. An osteoblast cell culture model system was utilized to investigate the effect of plasma nitriding of the stents on the biological response towards the stents, using biological criteria such as cell viability, alkaline phosphatase and nitric oxide production. In terms of cell viability and alkaline phosphatase production, the plasma nitriding procedure did not appear to negatively affect the biocompatibility of the 316L steel stents. However, in terms of nitric oxide production that was slightly increased in the presence of the plasma-nitrided stents, an indirect improvement in the biocompatibility could possibly be expected.

  10. Improved blood compatibility of rapamycin-eluting stent by incorporating curcumin.

    PubMed

    Pan, C J; Tang, J J; Shao, Z Y; Wang, J; Huang, N

    2007-09-01

    This paper dealt with improving the blood compatibility of the rapamycin-eluting stent by incorporating curcumin. The rapamycin- and rapamycin/curcumin-loaded PLGA (poly(d,l-lactic acid-co-glycolic acid)) coatings were fabricated onto the surface of the stainless steel stents using an ultrasonic atomization spray method. The structure of the coating films was characterized by Fourier transform infrared spectroscopy (FTIR). The optical microscopy and scanning electron microscopy (SEM) images of the drug-eluting stents indicated that the surface of all drug-eluting stents was very smooth and uniform, and there were not webbings and "bridges" between struts. There were not any cracks and delaminations on stent surface after expanded by the angioplasty balloon. The in vitro platelet adhesion and activation were investigated by static platelet adhesion test and GMP140 (P-selection), respectively. The clotting time was examined by activated partially prothromplastin time (APTT) test. The fibrinogen adsorption on the drug-loaded PLGA films was evaluated by enzyme-linked immunosorbent assay (ELISA). All obtained data showed that incorporating curcumin in rapamycin-loaded PLGA coating can significantly decrease platelet adhesion and activation, prolong APTT clotting time as well as decrease the fibrinogen adsorption. All results indicated that incorporating curcumin in rapamycin-eluting coating obviously improve the blood compatibility of rapamycin-eluting stents. It was suggested that it may be possible to develop a drug-eluting stent which had the characteristics of not only good anti-proliferation but also improved anticoagulation.

  11. In Vivo and In Vitro Nitinol Corrosion Properties

    NASA Astrophysics Data System (ADS)

    Lonn, Melissa K.; Metcalf, Justin M.; Choules, Brian D.

    2015-09-01

    Regulatory authorities often require in vitro testing on medical devices prior to approval. Current standardized corrosion testing methods (ASTM F2129) require testing in a non-physiologic, de-oxygenated solution for a pre-exposure time of ≤1 h; however, no correlations between the prescribed simulated environment and whole blood conditions have been elucidated. This study compared open circuit potential (OCP), breakdown potentials (Eb), Eb - OCP, and cyclic polarization curves tested in vivo (OCP only) and in vitro in whole blood to those tested in phosphate-buffered saline (PBS). Two oxide thicknesses of Nitinol, two solution oxygen contents (deaerated and aerated solutions), and two pre-exposure durations (acute and chronic) were investigated. The in vitro OCP in whole blood was not significantly different than the in vivo OCP, suggesting that whole blood in vitro can be used to determine baseline corrosion behavior of medical implants. Eb - OCP tested per ASTM F2129 was comparable to acute whole blood and was conservative compared to chronic whole blood for both oxide thicknesses. However, OCP, Eb, and cyclic polarization curves were not always comparable to whole blood. Testing in aerated PBS achieved Eb, Eb - OCP, and cyclic polarization curves that were comparable to or more conservative than whole blood testing, regardless of pre-exposure duration and oxide thickness.

  12. Passive base isolation with superelastic nitinol SMA helical springs

    NASA Astrophysics Data System (ADS)

    Huang, Bin; Zhang, Haiyang; Wang, Han; Song, Gangbing

    2014-06-01

    Seismic isolation of structures such as multi-story buildings, nuclear reactors, bridges, and liquid storage tanks should be designed to preserve structural integrity. By implementing seismic isolation technology, the deformation of superstructures can be dramatically reduced, consequently helping to protect their safety as well. In this paper, an innovative type of passive base isolation system, which is mainly composed of superelastic nitinol SMA helical springs, is developed. In order to verify the effectiveness of the proposed system, a two-story experimental steel frame model is constructed, and two superelastic SMA helical springs are thermo-mechanically built in the laboratory. To describe the nonlinear mechanical properties of the superelastic SMA helical springs under reciprocating load, a phenomenological model is presented in terms of a series of tensile tests. Afterwards, a numerical model of the two-story frame with the suggested isolation system is set up to simulate the response of the isolated frame subjected to an earthquake. Both the experimental and the numerical simulation results indicate that the proposed base isolation system can remarkably suppress structural vibrations and has improved isolation effects when compared with a steel spring isolation system. Due to the capabilities of energy dissipation as well as fully re-centering, it is very applicable to utilize the suggested isolation system in base isolated structures to resist earthquakes.

  13. [Larynx: implants and stents].

    PubMed

    Sittel, C

    2009-05-01

    There is a wide variety of devices and materials to be implanted into the human larynx. Some are intended to remain only for a period of time, like laryngeal stents. If removal is not intended the device meets the definition for a medical implant. The majority of implants is used for the treatment of unilateral vocal fold immobility. There a 2 types of implants serving this purpose: Implants in a stricter sense are devices of solid material, which are brought into the paraglottic space through a window in the laryngeal framework (medialization thyroplasty). Several different products are presented in this review. In contrast, there are different substances available for endoscopic injection into the paralyzed vocal fold (injection laryngoplasty). Since some of these substances show a corpuscular consistency and a high viscosity they need to be deposited into the lateral paraglottic space. Therefore, the term "injectable implants" has been coined for these materials. The different substances available are discussed in detail in this review. Laryngeal stents are primarily used in the early postoperative phase after open reconstruction of the larynx. The different devices available on the market are described with their specific characteristics and intended use.

  14. Enteral metallic stenting by balloon enteroscopy for obstruction of surgically reconstructed intestine.

    PubMed

    Nakahara, Kazunari; Okuse, Chiaki; Matsumoto, Nobuyuki; Suetani, Keigo; Morita, Ryo; Michikawa, Yosuke; Ozawa, Shun-ichiro; Hosoya, Kosuke; Kobayashi, Shinjiro; Otsubo, Takehito; Itoh, Fumio

    2015-06-28

    We present three cases of self-expandable metallic stent (SEMS) placement using a balloon enteroscope (BE) and its overtube (OT) for malignant obstruction of surgically reconstructed intestine. A BE is effective for the insertion of an endoscope into the deep bowel. However, SEMS placement is impossible through the working channel, because the working channel of BE is too small and too long for the stent device. Therefore, we used a technique in which the BE is inserted as far as the stenotic area; thereafter, the BE is removed, leaving only the OT, and then the stent is placed by inserting the stent device through the OT. In the present three cases, a modification of this technique resulted in the successful placement of the SEMS for obstruction of surgically reconstructed intestine, and the procedures were performed without serious complications. We consider that the present procedure is extremely effective as a palliative treatment for distal bowel stenosis, such as in the surgically reconstructed intestine.

  15. Telescoping Dual Covered Stent Graft Construct for Endovascular Treatment of a Giant Extracranial Carotid Artery Pseudoaneurysm

    PubMed Central

    Ding, Dale; Starke, Robert M.; Moriarty, Maurice; Brew, Stefan

    2016-01-01

    Large pseudoaneurysms which compress the parent vessel are challenging lesions to successfully treat with endovascular therapy. We describe the endovascular treatment of a giant extracranial carotid artery (ECCA) pseudoaneurysm resulting in substantial mass effect on the common carotid artery (CCA) bifurcation using a telescoping dual covered stent graft construct. A 56-year-old male was diagnosed with an 8.5 cm × 13 cm pseudoaneurysm arising from the left CCA bifurcation, which was causing luminal narrowing of the CCA and proximal internal carotid artery (ICA). The patient underwent endovascular intervention, during which a balloon-expandable covered stent was deployed within a heparin-bonded covered stent, such that the overall construct spanned from the CCA to the lower cervical ICA. The employment of a telescoping dual covered stent technique can successfully treat appropriately selected patients with large or giant ECCA pseudoaneurysms, with the concomitant goals of excluding the pseudoaneurysm and restoring the luminal caliber of the parent artery. PMID:28163519

  16. Telescoping Dual Covered Stent Graft Construct for Endovascular Treatment of a Giant Extracranial Carotid Artery Pseudoaneurysm.

    PubMed

    Ding, Dale; Starke, Robert M; Moriarty, Maurice; Brew, Stefan

    2016-12-01

    Large pseudoaneurysms which compress the parent vessel are challenging lesions to successfully treat with endovascular therapy. We describe the endovascular treatment of a giant extracranial carotid artery (ECCA) pseudoaneurysm resulting in substantial mass effect on the common carotid artery (CCA) bifurcation using a telescoping dual covered stent graft construct. A 56-year-old male was diagnosed with an 8.5 cm × 13 cm pseudoaneurysm arising from the left CCA bifurcation, which was causing luminal narrowing of the CCA and proximal internal carotid artery (ICA). The patient underwent endovascular intervention, during which a balloon-expandable covered stent was deployed within a heparin-bonded covered stent, such that the overall construct spanned from the CCA to the lower cervical ICA. The employment of a telescoping dual covered stent technique can successfully treat appropriately selected patients with large or giant ECCA pseudoaneurysms, with the concomitant goals of excluding the pseudoaneurysm and restoring the luminal caliber of the parent artery.

  17. [Research on the coupling expansion deformation behavior of coronary stainless steel stent in vitro].

    PubMed

    Wang, Wenwen; Feng, Haiquan; Wang, Xiao; Chen, Yanlong; Zhang, Ruimin

    2013-10-01

    We analyzed coupling expansion process of three different structures of stainless steel (SUS-316LI) stents by using finite element method (FEM) simulation in this study. Firstly we made specific analysis and comparison between three stents of deformation and stress-strain distribution in the coupling expansion process and then we described the shortening rate, radial bounce rate, expand nonuniformity, safety factor and other biological mechanics performance of the three stents quantitatively. And finally we analyzed the influencing factors and the best structure of the three kinds of the stainless steel stent comprehensively. Through all the processes, we have verified the rationality of the finite element simulation result by using the expansion test in vitro.

  18. A Source Manual for Information on Nitinol and NiTi. First Revision

    DTIC Science & Technology

    1980-02-01

    Arnold Oak Ridge, TE 37830 Library of Congress Washington, D.C. 20540 Attn: Gift and Fxchange Division 53 -. r ; , •- 7 .," " .. . i i /lil i l l I I l...Banks, R.; Wahlig, M., NITINOL Engine Development LBL-5293 ERDA Contract W-7405-ENG-48 International Solar Energy Society Meeting, Winnipeg , Canada...Shape Memory Structures, Master Thesis, Naval Postgrad. School , AD-A009 967*, March 1975. 75A2 Anon., NITINOL: Metal with a Memory, All Hands, July 1975 p

  19. Preliminary Investigation of Surface Treatments to Enhance the Wear Resistance of 60-Nitinol

    NASA Technical Reports Server (NTRS)

    Stanford, Malcolm K.

    2016-01-01

    The use of protective surface treatments on 60-Nitinol (60wt%Ni-40wt%Ti) was studied. Various nitriding techniques as well as a (Ti, Al)N coating were evaluated visually, microscopically, and by hardness and scratch testing. The chemical composition of the surface treatments was investigated by x-ray techniques. The results indicate that very hard (greater than 1,000 HK) and adherent surface layers can be produced on 60-Nitinol. Further work is needed to determine the tribological properties of these surface treatments in relevant operating environments.

  20. Oxide Ceramic Films Grown on 60 Nitinol for NASA and Department of Defense Applications

    NASA Technical Reports Server (NTRS)

    Miyoshi, Kazuhisa; Street, Kenneth W.; Lukco, Dorothy; Cytron, Sheldon J.

    2005-01-01

    Both the NASA Glenn Research Center and the U.S. Army Research Laboratory, Development and Engineering Center (ARDEC) have worked to develop oxide ceramic films grown on 60 nitinol (60-wt% nickel and 40-wt% titanium) to decrease friction and increase wear resistance under unlubricated conditions. In general, oxide and nonoxide ceramic films have unique capabilities as mechanical-, chemical-, and thermal-barrier materials in diverse applications, including high-temperature bearings and gas bearings requiring low friction, wear resistance, and chemical stability. All oxide ceramic films grown on 60 nitinol were furnished by ARDEC, and materials and surface characterization and tribological experiments were conducted at Glenn.

  1. Postoperative analysis of the mechanical interaction between stent and host tissue in patients after transcatheter aortic valve implantation.

    PubMed

    Hopf, Raoul; Sündermann, Simon H; Born, Silvia; Ruiz, Carlos E; Van Mieghem, Nicolas M; de Jaegere, Peter P; Maisano, Francesco; Falk, Volkmar; Mazza, Edoardo

    2017-02-28

    The analysis is based on a finite element procedure to extract the contact forces between an implanted Nitinol stent and the surrounding host tissue using postoperative CT images. The methodology was applied for patients (N=46) which have undergone a TAVI procedure with the Medtronic CoreValve Revalving System (MCRS) to obtain corresponding deformation and force maps. The postoperative CT data were recorded for each patient in both systolic and diastolic phase of the heart cycle. Scalar parameters were defined, which map deformed geometry and contact force field to mechanically relevant quantities: radial dilatation, radial shape distortion, non-convex points, mean force, a force deviation measure and a pressure equivalent. The latter demonstrates that in the area of the aortic root, the added circumferential loading is of the same order as the baseline average blood pressure, thus leading to a doubling of the local mechanical load. Generally the force distribution along the stent is non-homogeneous. A comparison of systolic and diastolic data revealed slightly higher contact forces during the diastole, indicating that the stent has to carry more load in this phase. The geometrical and mechanical parameters were compared for two types of clinical complication: para-valvular leakage (PVL) and permanent pacemaker requirement (PPM). It was found that an increase in mean force can be associated with both complications; significantly for PVL and as a trend for PPM.

  2. Use of PTFE Stent Grafts for Hemodialysis-related Central Venous Occlusions: Intermediate-Term Results

    SciTech Connect

    Kundu, Sanjoy Modabber, Milad; You, John M.; Tam, Paul; Nagai, Gordon; Ting, Robert

    2011-10-15

    Purpose: To assess the safety and effectiveness of a polytetrafluoroethylene (PTFE) encapsulated nitinol stents (Bard Peripheral Vascular, Tempe, AZ) for treatment of hemodialysis-related central venous occlusions. Materials and Methods: Study design was a single-center nonrandomized retrospective cohort of patients from May 2004 to August 2009 for a total of 64 months. There were 14 patients (mean age 60 years, range 50-83 years; 13 male, 1 female). All patients had autogenous fistulas. All 14 patients had central venous occlusions and presented with clinical symptoms of the following: extremity swelling (14%, 2 of 14), extremity and face swelling (72%, 10 of 14), and face swelling/edema (14%, 2 of 14). There was evidence of access dysfunction with decreased access flow in 36% (5 of 14) patients. There were prior interventions or previous line placement at the site of the central venous lesion in all 14 patients. Results were assessed by recurrence of clinical symptoms and function of the access circuit (National Kidney Foundation recommended criteria). Results: Sixteen consecutive straight stent grafts were implanted in 14 patients. Average treated lesion length was 5.0 cm (range, 0.9-7 cm). All 14 patients had complete central venous occlusion (100% stenosis). The central venous occlusions were located as follows: right subclavian and brachiocephalic vein (21%, 3 of 14), right brachiocephalic vein (36%, 5 of 14), left brachiocephalic vein (36%, 5 of 14), and bilateral brachiocephalic vein (7%, 1 of 14). A total of 16 PTFE stent grafts were placed. Ten- or 12-mm-diameter PTFE stent grafts were placed. The average stent length was 6.1 cm (range, 4-8 cm). Technical (deployment), anatomic (<30% residual stenosis), clinical (resolution of symptoms), and hemodynamic (resolution of access dysfunction) success were 100%. At 3, 6, and 9 months, primary patency of the treated area and access circuit were 100% (14 of 14). Conclusions: This PTFE encapsulated stent graft

  3. Renal Stenting from the Radial Artery: A Novel Approach

    SciTech Connect

    Kessel, David O.; Robertson, Iain; Taylor, Edward J.; Patel, Jai V.

    2003-04-15

    Purpose: To describe the technique and feasibility of renal artery angioplasty and stenting from the radial artery. Methods: A series of 19 patients were evaluated for transradial renal artery intervention. Procedures were performed using carbon dioxide gas (CO{sub 2}) as the preferred angiographic contrast agent. Intervention was performed through a 5 Fr radial artery sheath using low-profile balloons and balloon-expandable stents. Results: Nineteen patients with 26 stenosed renal arteries were considered for treatment via the radial route. A negative Allen's test precluded radial puncture in two (11%). In one patient the descending aorta could not be catheterized. Stenting from the radial route was successful in 22 renal arteries in 16 patients. On an intention-to-treat basis 16 of the 19 (84%) were treatable from the radial route. In the 17 patients with radial access technical success was 94% (16 of 17) patients and 91% (21 of 23) of renal arteries. One patient experienced a cerebrovascular event during intervention. Conclusion: Transradial renal artery intervention is technically feasible using low-profile angioplasty balloons and stents.This route offers advantages in renal arteries with a caudal angulation and in patients with diseases or tortuous iliac arteries.

  4. Silane surface modification for improved bioadhesion of esophageal stents

    PubMed Central

    Karakoy, Mert; Gultepe, Evin; Pandey, Shivendra; Khashab, Mouen A.; Gracias, David H.

    2014-01-01

    Stent migration occurs in 10-40% of patients who undergo placement of esophageal stents, with higher migration rates seen in those treated for benign esophageal disorders. This remains a major drawback of esophageal stent therapy. In this paper, we propose a new surface modification method to increase the adhesion between self-expandable metallic stents (SEMS) and tissue while preserving their removability. Taking advantage of the well-known affinity between epoxide and amine terminated silane coupling agents with amine and carboxyl groups that are abundant in proteins and related molecules in the human body; we modified the surfaces of silicone coated esophageal SEMS with these adhesive self-assembled monolayers (SAMs). We utilized vapor phase silanization to modify the surfaces of different substrates including PDMS strips and SEMS, and measured the force required to slide these substrates on a tissue piece. Our results suggest that surface modification of esophageal SEMS via covalent attachment of protein-binding coupling agents improves adhesion to tissue and could offer a solution to reduce SEMS migration while preserving their removability. PMID:25663731

  5. Silane surface modification for improved bioadhesion of esophageal stents

    NASA Astrophysics Data System (ADS)

    Karakoy, Mert; Gultepe, Evin; Pandey, Shivendra; Khashab, Mouen A.; Gracias, David H.

    2014-08-01

    Stent migration occurs in 10-40% of patients who undergo placement of esophageal stents, with higher migration rates seen in those treated for benign esophageal disorders. This remains a major drawback of esophageal stent therapy. In this paper, we propose a new surface modification method to increase the adhesion between self-expandable metallic stents (SEMS) and tissue while preserving their removability. Taking advantage of the well-known affinity between epoxide and amine terminated silane coupling agents with amine and carboxyl groups that are abundant in proteins and related molecules in the human body; we modified the surfaces of silicone coated esophageal SEMS with these adhesive self-assembled monolayers (SAMs). We utilized vapor phase silanization to modify the surfaces of different substrates including PDMS strips and SEMS, and measured the force required to slide these substrates on a tissue piece. Our results suggest that surface modification of esophageal SEMS via covalent attachment of protein-binding coupling agents improves adhesion to tissue and could offer a solution to reduce SEMS migration while preserving their removability.

  6. Fabrication of a silver particle-integrated silicone polymer-covered metal stent against sludge and biofilm formation and stent-induced tissue inflammation

    PubMed Central

    Lee, Tae Hoon; Jang, Bong Seok; Jung, Min Kyo; Pack, Chan Gi; Choi, Jun-Ho; Park, Do Hyun

    2016-01-01

    To reduce tissue or tumor ingrowth, covered self-expandable metal stents (SEMSs) have been developed. The effectiveness of covered SEMSs may be attenuated by sludge or stone formation or by stent clogging due to the formation of biofilm on the covering membrane. In this study, we tested the hypothesis that a silicone membrane containing silver particles (Ag-P) would prevent sludge and biofilm formation on the covered SEMS. In vitro, the Ag-P-integrated silicone polymer-covered membrane exhibited sustained antibacterial activity, and there was no definite release of silver ions from the Ag-P-integrated silicone polymer membrane at any time point. Using a porcine stent model, in vivo analysis demonstrated that the Ag-P-integrated silicone polymer-covered SEMS reduced the thickness of the biofilm and the quantity of sludge formed, compared with a conventional silicone-covered SEMS. In vivo, the release of silver ions from an Ag-P-integrated silicone polymer-covered SEMS was not detected in porcine serum. The Ag-P-integrated silicone polymer-covered SEMS also resulted in significantly less stent-related bile duct and subepithelium tissue inflammation than a conventional silicone polymer-covered SEMS. Therefore, the Ag-P-integrated silicone polymer-covered SEMS reduced sludge and biofilm formation and stent-induced pathological changes in tissue. This novel SEMS may prolong the stent patency in clinical application. PMID:27739486

  7. Design, Manufacturing, and In Vitro Testing of a Patient-Specific Shape-Memory Expander for Nose Reconstruction With Forehead Flap Technique.

    PubMed

    Borghi, Alessandro; Rodgers, Will; Schievano, Silvia; Ponniah, Allan; O'Hara, Justine; Jeelani, Owase; Dunaway, David

    2016-01-01

    Forehead skin is widely acknowledged as a good donor site for total nasal reconstruction, thanks to its matching color, texture, and abundant vascularity. The forehead flap technique uses an axial pattern flap forehead skin to replace missing nasal tissue. To increase the amount of available tissue and reduce the size of the tissue defect after flap mobilization, tissue expanders may be used. Although this is a relatively established technique, limitations include reduced moldability of the forehead skin (which is thicker than the nasal skin), and the need for multiple sessions of expansion to achieve a sufficient yield to close the forehead.Shape-memory metals, such as nitinol, can be programmed to "remember" complex shapes. In this work, the methodology for producing a prototype of nitinol tissue expander able to mold the skin in a predetermined patient-specific skin shape is described. A realistic nose mold was manufactured using metal rapid prototyping; nitinol sheet and mesh were molded into nose-shape constructs, having hyperelastic as well as shape-memory capability. Computed tomography scanning was performed to assess the ability of the structure to regain its shape after phase transformation upon cooling within 2% of initial dimensions. The prototypes were implanted in a pig forehead to test its ability to impose a nose shape to the forehead skin.The shape-memory properties of nitinol offer the possibility of producing bespoke tissue expanders able to deliver complex, precisely designed skin envelopes. The hyperelastic properties of nitinol allow constant preprogrammed expansion forces to be generated throughout the expansion process.

  8. Effect of Inclusion Size and Distribution on the Corrosion Behavior of Medical-Device Grade Nitinol Tubing

    NASA Astrophysics Data System (ADS)

    Wohlschlögel, Markus; Steegmüller, Rainer; Schüßler, Andreas

    2014-07-01

    Nonmetallic inclusions in Nitinol, such as carbides (TiC) and intermetallic oxides (Ti4Ni2O x ), are known to be triggers for fatigue failure of Nitinol medical devices. These mechanically brittle inclusions are introduced during the melting process. As a result of hot and cold working in the production of Nitinol tubing inclusions are fractionalized due to the mechanical deformation imposed. While the role of inclusions regarding Nitinol fatigue performance has been studied extensively in the past, their effect on Nitinol corrosion behavior was investigated in only a limited number of studies. The focus of the present work was to understand the effect of inclusion size and distribution on the corrosion behavior of medical-device grade Nitinol tubing made from three different ingot sources during different manufacturing stages: (i) for the initial stage (hollow: round bar with centric hole), (ii) after hot drawing, and (iii) after the final drawing step (final tubing dimensions: outer diameter 0.3 mm, wall thickness 0.1 mm). For one ingot source, two different material qualities were investigated. Potentiodynamic polarization tests were performed for electropolished samples of the above-mentioned stages. Results indicate that inclusion size rather than inclusion quantity affects the susceptibility of electropolished Nitinol to pitting corrosion.

  9. Investigation of crystal structures of one-way shape memory Nitinol wire actuators for active steerable needle

    NASA Astrophysics Data System (ADS)

    Honarvar, Mohammad; Konh, Bardia; Hutapea, Parsaoran

    2015-04-01

    Due to its outstanding properties of Nitinol, known as shape memory and superelasticity, Nitinol wires have been used as actuators in many medical devices. For the medical applications, it is critical to have a consistent strain response of Nitinol wires. This work focuses on studying the effect of parameters such as biased stress, maximum temperature, and wire diameters that influence the strain response of Nitinol wires. Specifically, Nitinol phase transformations were studied from microstructural point of view. The crystal structures of one-way shape memory Nitinol wires of various diameters under different thermomechanical loading conditions were studied using X-Ray Diffraction (XRD) method. The location and intensity of characteristic peaks were determined prior and after the thermomechanical loading cycles. It was observed that Nitinol wires of diameters less than 0.19 mm exhibit unrecovered strain while heated to the range of 70ºC to 80ºC in a thermal cycle, whereas no unrecovered strains were found in larger wires. The observation was supported by the XRD patterns where the formation of R-phase crystal structure was showed in wire diameters less than 0.19 mm at room temperature.

  10. Advances in Ureteral Stent Design

    NASA Astrophysics Data System (ADS)

    Denstedt, John D.

    2007-04-01

    Ureteral stents are commonly used in urolithiasis patients for relief of obstruction or in association with stone treatments such as ureteroscopy and extracorporeal shock wave lithotripsy. There are currently many different bulk materials and coatings available for the manufacture of ureteral stents, however the ideal material has yet to be discovered. All potential biomaterials must undergo rigorous physical and biocompatibility testing before commercialization and use in humans. Despite significant advances in basic science research involving biocompatibility issues and biofilm formation, infection and encrustation remain associated with the use of biomaterials in the urinary tract. There have been many significant advances in the design of ureteral stents in recent years and these will be highlighted along with a discussion of future aspects of biomaterials and use of stents in association with urolithiasis.

  11. Emergency cricothyroidotomy following tracheobronchial stenting.

    PubMed

    Cavinato, Simon Robert; Denning, Mike; Madden, Brendan P

    2017-02-24

    A man aged 51 years was referred for tracheobronchial stenting after a poorly differentiated oesophageal carcinoma had progressed to cause stridor. Bronchoscopy revealed a left vocal cord palsy and tumour infiltration into the trachea. A tracheobronchial stent was placed, and after distal migration was endoscopically resited. Returning from theatre, the patient developed severe upper airway obstruction that progressed to cause CO2 narcosis and loss of consciousness. A rapid sequence induction was initiated, and a Glidescope revealed bilateral vocal cord palsy with severe oedema causing an inability to pass a tube or stylet. Tracheostomy was attempted above the suprasternal notch but was obstructed by the stent. Oxygen saturations dropped steadily, reaching as low as 38%. Emergency cricothyroidotomy was performed, compliant with DAS guidelines, that proved successful. The stent was removed, which was blocked with blood and secretions, and tracheostomy was placed 2 days later. The patient made a full neurological recovery.

  12. Non-polymeric coatings to control drug release from metallic coronary stents

    NASA Astrophysics Data System (ADS)

    Gupta, Celia Edith Macias

    Percutaneous transluminal coronary angiography (PTCA) is a procedure used to re-open narrowed coronary arteries. During PTCA, a coronary stent is expanded inside a diseased vessel and serves as a scaffold to keep the artery open. The major drawback of stenting is restenosis---a re-narrowing of the vessel resulting from the hyperproliferation of smooth muscle cells. Drug eluting stents (DES) reduce the rate of restenosis compared to bare metal stents. Paclitaxel (PAT) is commonly used in DES for its ability to prevent restenosis. However, DES have been associated with thrombosis due to the polymer carrier that controls drug delivery. Therefore, there is a need to change the drug delivery mechanisms to eliminate the need of polymers. The goal of this dissertation is to develop a novel polymer-free drug eluting stent that controls drug release using nanoscale metal coatings. The coating was designed to release PAT as the metal slowly degrades in biological conditions. Once all the Paclitaxel has eluted from the surface, the coating will continue to degrade until the final result is a bare metal stent. The results of this study include a novel non-polymeric drug delivery system using nanoscale coatings that release Paclitaxel at a rate similar to commercial stents, as well as the biocompatibility and efficacy of these coatings. The non-polymeric drug delivery system described here achieved a Paclitaxel release profile equivalent to clinically available Paclitaxel-eluting stents and effectively inhibits smooth muscle cell proliferation, thereby completely eliminating the need for polymers to control drug release from coronary stents.

  13. Stenting for Peripheral Artery Disease of the Lower Extremities

    PubMed Central

    2010-01-01

    a combination of ultrasound and wave form recordings to evaluate arterial flow in blood vessels. The value of the ABI can provide an assessment of the severity of the disease. Other non invasive imaging techniques include: Computed Tomography (CT) and Magnetic Resonance Angiography (MRA). Definitive diagnosis of PAD can be made by an invasive catheter based angiography procedure which shows the roadmap of the arteries, depicting the exact location and length of the stenosis / occlusion. Angiography is the standard method against which all other imaging procedures are compared for accuracy. More than 70% of the patients diagnosed with PAD remain stable or improve with conservative management of pharmacologic agents and life style modifications. Significant PAD symptoms are well known to negatively influence an individual quality of life. For those who do not improve, revascularization methods either invasive or non-invasive can be used to restore peripheral circulation. Technology Under Review A Stent is a wire mesh “scaffold” that is permanently implanted in the artery to keep the artery open and can be combined with angioplasty to treat PAD. There are two types of stents: i) balloon-expandable and ii) self expandable stents and are available in varying length. The former uses an angioplasty balloon to expand and set the stent within the arterial segment. Recently, drug-eluting stents have been developed and these types of stents release small amounts of medication intended to reduce neointimal hyperplasia, which can cause re-stenosis at the stent site. Endovascular stenting avoids the problem of early elastic recoil, residual stenosis and flow limiting dissection after balloon angioplasty. Research Questions In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), is primary stenting more effective than percutaneous transluminal angioplasty (PTA) in improving patency? In

  14. Novel side branch ostial stent.

    PubMed

    Chen, Shao-Liang; Lv, Shu-Zheng; Kwan, Tak W

    2009-04-01

    Bifurcation lesions are technically challenging and plagued by a high incidence of restenosis, especially at the side branch orifice, which results in a more frequent need for revascularization during the follow-up period. This report discusses two clinical experiences with a novel side branch ostial stent, the BIGUARD stent, designed for the treatment of bifurcation lesions; procedural success with no in-hospital complications was observed in types IVb and Ia lesions.

  15. Clinical outcomes of compromised side branch (stent jail) after coronary stenting with the NIR stent.

    PubMed

    Bhargava, B; Waksman, R; Lansky, A J; Kornowski, R; Mehran, R; Leon, M B

    2001-11-01

    Acute side-branch (SB) compromise or occlusion stent jail after native coronary stenting is a matter of concern. Attempts at maintaining SB patency can be a technical challenge. The purpose of this study was to determine the clinical impact of SB compromise or occlusion in patients undergoing stenting of parent vessel lesions. We evaluated in-hospital and long-term clinical outcomes (death, Q-wave myocardial infarction, and repeat revascularization rates at 6 months) in 318 consecutive patients undergoing NIR stent implantation across an SB. Based on independent angiographic analysis, 218 (68.6%) patients had no poststent SB compromise, 85 (26.7%) patients had narrowed SB (> 70% narrowing, without total occlusion), and 15 (4.7%) patients had an occluded SB after stent implantation. The baseline patient and lesion characteristics were similar between the groups. Procedural success was 100%. Patients with SB occlusion had a higher stents/lesion ratio (P < 0.006). Side-branch occlusion was associated with higher in-hospital ischemic complications (Q-wave myocardial infarction, 7%; non-Q-wave myocardial infarction, 20%; P < 0.05) compared to patients with SB compromise or normal SB. At 6-month follow-up, there was a trend for more myocardial infarctions in the group with SB occlusion during the index procedure (Q-wave myocardial infarction, 7% vs. 1% in the narrowed and 0% in normal SB; P = 0.09). However, late target lesion revascularization and mortality were similar in the three groups (P = 0.91). SB occlusion after parent vessel stenting is associated with more frequent in-hospital Q-wave and non-Q-wave myocardial infarctions. However, with the NIR stent, side-branch compromise or occlusion does not influence late (6 month) major adverse events, including death, myocardial infarction, or need for repeat revascularization.

  16. Complete endoscopic removal of colloid cyst using a nitinol basket retriever.

    PubMed

    Schirmer, Clemens M; Heilman, Carl B

    2011-04-01

    Neuroendoscopic treatment of colloid cysts is limited by the reach and flexibility of the instruments that can be passed through the working channels of the rigid neuroendoscope. The authors describe a case of a third ventricular colloid cyst where a large solid colloid fragment was recovered using a nitinol stone retrieval basket as a flexible wall-guided atraumatic salvage instrument. A flexible nitinol stone retrieval basket was successfully used through an endoscopic working channel to retrieve a large portion of the colloid cyst from the occipital horn of the lateral ventricle in a 70-year-old man who presented with progressive memory loss, urinary incontinence, and slowness of gait. A flexible nitinol stone retrieval basket can be safely and effectively maneuvered in the ventricular system, using the ventricular wall for deflection, and can be used to retrieve colloid cyst fragments as a salvage technique. Remaining free-floating large colloid cyst fragments in the ventricular system do not necessarily require a second craniotomy or bur hole for access but may be retrieved using a nitinol stone retrieval basket.

  17. Multiaxial fatigue modeling for Nitinol shape memory alloys under in-phase loading.

    PubMed

    Mahtabi, M J; Shamsaei, Nima

    2015-03-01

    The realistic loading condition for many components is multiaxial arising from multidirectional loading or geometry complexities. In this study, some multiaxial stress-based classical and critical plane fatigue models are briefly reviewed and their application for martensitic Nitinol under torsion and in-phase axial-torsion loading is evaluated. These models include von Mises equivalent stress, Tresca, Findley, McDiarmid, and a proposed stress-based Fatemi-Socie-type model. As the fatigue cracks appear to be on the maximum shear plane for the martensitic Nitinol, all the models examined here consider the shear stress as the primary damage parameter. Among all the models considered in this study, the proposed Fatemi-Socie-type model provides a better prediction for fatigue lives when compared to torsion and in-phase multiaxial fatigue experimental data from literature. Analyses indicate that critical plane approaches are more appropriate for multiaxial fatigue prediction of Nitinol alloys, at least in martensitic phase. Finally, recommendations are made to calibrate more reliable multiaxial fatigue models for Nitinol.

  18. Measurement of Nitinol Recovery Distance Using Pseudoelastic Intramedullary Nails for Tibiotalocalcaneal Arthrodesis.

    PubMed

    Kildow, Beau J; Gross, Christopher E; Adams, Samuel D; Parekh, Selene G

    2016-07-07

    Background Tibiotalocalcaneal arthrodesis is a salvage procedure for patients with complex disease of the ankle and subtalar joints. Despite the clinical efficacy and mechanical advantage of intramedullary nails, complications, such as nonunion, are common. It may be possible to sustain compression in the face of bone resorption and implant loosening over the course of healing using a novel pseudoelastic intramedullary nail with an internal nitinol element. Methods We identified 15 patients with average age of 54.7 years (range, 28-75 years) who had undergone a tibiotalocalcaneal arthrodesis using a pseudoelastic intramedullary nail. Serial radiographs were used to determine the amount and rate of nitinol element migration over the first 3 postoperative months. Results Postoperatively, there was at least 2.38 mm of nitinol element migration proximally with mean of 5.58 mm (± 1.38), (range, 2.38-8.11 mm). Average follow-up time was 195 days (± 106.3), (range, 89-490 days). On average, 86% of the total recovered distance took place within the first 39.7 days (±10.03). Conclusions The nitinol element recovers distance when stretched intraoperatively and maintains moderate compression in response to bone resorption. Further studies are needed to assess if this increased compression lends itself to higher fusion rates than traditional intramedullary nails.

  19. NiTiNol Hernia Device Stability in Inguinal Hernioplasty Without Fixation

    PubMed Central

    2011-01-01

    Background and Objective: To determine whether the NiTiNol frame of a novel hernia repair device utilizing polypropylene mesh for inguinal hernioplasty remains stable and intransient without fixation after a minimum of 6 months. Methods: Twenty patients had 27 inguinal hernias repaired using a novel hernia repair device that has a NiTiNol frame without any fixation. Initial single-view, postoperative X-rays were compared with a second X-ray obtained at least 6 months later. The NiTiNol frame, which can be easily visualized on a plain X-ray, was measured in 2 dimensions, as were anatomic landmarks. The measurements obtained and the appearances of the 2 X-rays were compared to determine the percentage of change in device size and device stability with regard to device location and shape. Results: There were minimal changes noted between the 2 sets of measurements obtained with an overall trend towards a slight increase in the size of the hernia repair device. The devices demonstrated intransience of position and stability of shape. Conclusions: The NiTiNol frame of a novel hernia repair device utilizing polypropylene mesh exhibits radiographic evidence of size and shape stability and intransience of position without fixation when used in inguinal hernioplasty after a minimum follow-up of 6 months. PMID:21902967

  20. Study of Unrecovered Strain and Critical Stresses in One-Way Shape Memory Nitinol

    NASA Astrophysics Data System (ADS)

    Honarvar, Mohammad; Datla, Naresh V.; Konh, Bardia; Podder, Tarun K.; Dicker, Adam P.; Yu, Yan; Hutapea, Parsaoran

    2014-08-01

    Unique thermomechanical properties of Nitinol known as shape memory and superelasticity make it applicable for different fields such as biomedical, structural, and aerospace engineering. These unique properties are due to the comparatively large recoverable strain, which is being produced in a martensitic phase transformation. However, under certain ranges of stresses and temperatures, Nitinol wires exhibit unrecovered strain. For cyclic applications, it is important to understand the strain behavior of Nitinol wires. In this study, the unrecovered strain of different Nitinol wire diameters was investigated using constant stress experiment. Uniaxial tensile test has been also performed to find the range of critical stresses. It was observed that the unrecovered strain produced in the first loading-unloading cycle affects the total strain in the subsequent cycles. Moreover, a critical range of stress was found beyond which the unrecovered strain was negligible while the wires heated up to the range of 70-80°C, depending on the wire diameters. The unrecovered strain of wire diameters of 0.19 mm and less was found to be sensitive to the critical stress. On the other hand, for wire diameters bigger than 0.19 mm this connection between the unrecovered strain and the critical stress was not observed for the same range of heating temperature.

  1. [Intracoronary ultrasound: A necessary tool for stent implantation? Arguments in favor].

    PubMed

    Botas, J

    1999-06-01

    Intracoronary ultrasound (ICUS), as opposed to angiography, provides high resolution, tomographic images of the coronary vessel and lumen. Because of its superior diagnostic sensitivity ICUS is indicated in the evaluation of suboptimal results and complications following stent implantation. Only a few years ago the use of stents was limited by a high incidence of subacute thrombosis. ICUS demonstrated that the deployment technique used at that time was inadequate and that stent expansion could be improved by the routine use of high pressure inflation, leading to a simplification in the anticoagulation regimen and a decrease in the subacute thrombosis rate in elective procedures to < or = 1%. However, the routine use of high balloon pressures does not assure an adequate expansion of the stent. Only about one third of the stents deployed under angiographic guidance are optimally expanded, with intra-stent luminal dimensions similar to the adjacent, reference, luminal sizes. Significantly, these underdeployed stents can be recognized by ICUS and a large proportion adequately expanded. It should be emphasized that the best predictors of stent restenosis are two ICUS parameters, the postprocedural luminal dimensions and the % cross sectional narrowing, and not the angiographic parameters. Likewise, two of the lowest restenosis rates ever reported (12.8% and 7.3%) have occurred in two studies (WEST-2 and MUSIC) in which stent deployment was guided by ICUS. Two trials (AVID and OPTICUS) have been specifically designed to test the hypothesis that routine use of ICUS to guide stent implantation could diminish the restenosis rate, but their final results are not yet available. The CRUISE study was designed to evaluate the impact of routine ICUS not on angiographic restenosis but on the clinical need of revascularization. In this trial, the larger luminal dimensions of the stents implanted under ICUS guidance translated into a 40% reduction in the 6 month revascularization

  2. Two Cases of Immediate Stent Fracture after Zotarolimus-Eluting Stent Implantation

    PubMed Central

    Lee, Pil Hyung; Lee, Seung-Whan; Lee, Jong-Young; Kim, Young-Hak; Lee, Cheol Whan; Park, Duk-Woo; Park, Seong-Wook

    2015-01-01

    Drug-eluting stent (DES) implantation is currently the standard treatment for various types of coronary artery disease. However, previous reports indicate that stent fractures, which usually occur after a period of time from the initial DES implantation, have increased during the DES era; stent fractures can contribute to unfavorable events such as in-stent restenosis and stent thrombosis. In our present report, we describe two cases of zotarolimus-eluting stent fracture: one that was detected six hours after implementation, and the other case that was detected immediately after deployment. Both anatomical and technical risk factors contributed to these unusual cases of immediate stent fracture. PMID:25653706

  3. Thermomechanical characterization of one-way shape memory Nitinol as an actuator for active surgical needle

    NASA Astrophysics Data System (ADS)

    Honarvar, Mohammad

    Needle-based intervention insertion is one of the common surgical techniques used in many diagnostic and therapeutic percutaneous procedures. The success of such procedures highly depends on the accuracy of needle placement at target locations. An active needle has the potential to enhance the accuracy of needle placement as well as to improve clinical outcome. Bending forces provided by the attached actuators can assist the maneuverability in order to reach the targets following a desired trajectory. There are three major research parts in the development of active needle project in the Composites Laboratory of Temple University. They are thermomechanical characterization of shape memory alloy (SMA) or Nitinol as an actuator for smart needle, mechanical modeling and design of smart needles, and study of tissue needle interaction. The characterization of SMA is the focus of this dissertation. Unique thermomechanical properties of Nitinol known as shape memory effect and superelasticity make it applicable for different fields such as biomedical, structural and aerospace engineering. These unique behaviors are due to the comparatively large amount of recoverable strain which is being produced in a martensitic phase transformation. However, under certain ranges of stresses and temperatures, Nitinol wires exhibit unrecovered strain (also known as residual strain); which limits their applicability. Therefore, for applications that rely on the strain response in repetitive loading and unloading cycles, it is important to understand the generation of the unrecovered strain in the Nitinol wires. In this study, the unrecovered strain of Nitinol wires with various diameters was investigated, using two experimental approaches: constant stress and uniaxial tensile tests. Moreover, a critical range of stress was found beyond which the unrecovered strain was negligible at temperatures of 70 to 80°C depending on the wire diameter. Wire diameters varied from 0.10 to 0.29 mm were

  4. High compressive pre-strains reduce the bending fatigue life of nitinol wire.

    PubMed

    Gupta, Shikha; Pelton, Alan R; Weaver, Jason D; Gong, Xiao-Yan; Nagaraja, Srinidhi

    2015-04-01

    Prior to implantation, Nitinol-based transcatheter endovascular devices are subject to a complex thermo-mechanical pre-strain associated with constraint onto a delivery catheter, device sterilization, and final deployment. Though such large thermo-mechanical excursions are known to impact the microstructural and mechanical properties of Nitinol, their effect on fatigue properties is still not well understood. The present study investigated the effects of large thermo-mechanical pre-strains on the fatigue of pseudoelastic Nitinol wire using fully reversed rotary bend fatigue (RBF) experiments. Electropolished Nitinol wires were subjected to a 0%, 8% or 10% bending pre-strain and RBF testing at 0.3-1.5% strain amplitudes for up to 10(8) cycles. The imposition of 8% or 10% bending pre-strain resulted in residual set in the wire. Large pre-strains also significantly reduced the fatigue life of Nitinol wires below 0.8% strain amplitude. While 0% and 8% pre-strain wires exhibited distinct low-cycle and high-cycle fatigue regions, reaching run out at 10(8) cycles at 0.6% and 0.4% strain amplitude, respectively, 10% pre-strain wires continued to fracture at less than 10(5) cycles, even at 0.3% strain amplitude. Furthermore, over 70% fatigue cracks were found to initiate on the compressive pre-strain surface in pre-strained wires. In light of the texture-dependent tension-compression asymmetry in Nitinol, this reduction in fatigue life and preferential crack initiation in pre-strained wires is thought to be attributed to compressive pre-strain-induced plasticity and tensile residual stresses as well as the formation of martensite variants. Despite differences in fatigue life, SEM revealed that the size, shape and morphology of the fatigue fracture surfaces were comparable across the pre-strain levels. Further, the mechanisms underlying fatigue were found to be similar; despite large differences in cycles to failure across strain amplitudes and pre-strain levels, cracks

  5. Cocaine-induced very late stent thrombosis.

    PubMed

    Shah, Priyank; Vasudev, Rahul; Abuarqoub, Ahmad Hisham; Shamoon, Fayez

    2016-10-12

    Cocaine misuse is a known cause of acute coronary syndrome (ACS). Management of these patients has always been a challenge due to medication compliance and eventual risk of stent thrombosis. However, even cocaine misusers who are compliant with dual antiplatelet therapy have been reported to have stent thrombosis. All cases of cocaine-induced stent thrombosis reported in the literature have occurred within first year of stent placement (acute, subacute or late). We report a first case of very late stent thrombosis in a 54-year-old active cocaine misuser who presented with ST segment elevation myocardial infarction, which was successfully managed with percutaneous transluminal coronary angioplasty. A review of all the reported cases of cocaine-induced stent thrombosis is also discussed. Given the high mortality associated with stent thrombosis, treatment option for cocaine misusers presenting with ACS should be conservative when possible. If percutaneous coronary intervention is needed, bare metal stent should be preferred.

  6. Imaging of pediatric great vessel stents: Computed tomography or magnetic resonance imaging?

    PubMed Central

    van Hamersvelt, R. W.; Budde, R. P. J.; de Jong, P. A.; Schilham, A. M. R.; Bos, C.; Breur, J. M. P. J.; Leiner, T.

    2017-01-01

    Background Complications might occur after great vessel stent implantation in children. Therefore follow-up using imaging is warranted. Purpose To determine the optimal imaging modality for the assessment of stents used to treat great vessel obstructions in children. Material and methods Five different large vessel stents were evaluated in an in-vitro setting. All stents were expanded to the maximal vendor recommended diameter (20mm; n = 4 or 10mm; n = 1), placed in an anthropomorphic chest phantom and imaged with a 256-slice CT-scanner. MRI images were acquired at 1.5T using a multi-slice T2-weighted turbo spin echo, an RF-spoiled three-dimensional T1-weighted Fast Field Echo and a balanced turbo field echo 3D sequence. Two blinded observers assessed stent lumen visibility (measured diameter/true diameter *100%) in the center and at the outlets of the stent. Reproducibility of diameter measurements was evaluated using the intraclass correlation coefficient for reliability and 95% limits of agreement for agreement analysis. Results Median stent lumen visibility was 88 (IQR 86–90)% with CT for all stents at both the center and outlets. With MRI, the T2-weighted turbo spin echo sequence was preferred which resulted in 82 (78–84%) stent lumen visibility. Interobserver reliability and agreement was good for both CT (ICC 0.997, mean difference -0.51 [-1.07–0.05] mm) and MRI measurements (ICC 0.951, mean difference -0.05 [-2.52 –-2.41] mm). Conclusion Good in-stent lumen visibility was achievable in this in-vitro study with both CT and MRI in different great vessel stents. Overall reliability was good with clinical acceptable limits of agreement for both CT and MRI. However, common conditions such as in-stent stenosis and associated aneurysms were not tested in this in-vitro study, limiting the value of the in-vitro study. PMID:28141852

  7. Transient Hemolytic Anemia after Transjugular Intrahepatic Portosystemic Stent Shunt

    PubMed Central

    Garcia-Rebollo, Sagrario; Santolaria-Fernández, Francisco; Diaz-Romero, Francisco; Rodriguez-Moreno, Fermin; Martinez-Riera, Antonio

    1996-01-01

    Management of variceal bleeding secondary to portal hypertension constitutes a challenging issue, particularly in child's C cirrhotic patients. Recently, transjugular placement of self-expanding metallic stents in the liver (TIPS), creating a shunt between the portal and hepatic branches has provided a safe and promising therapeutic approach in this clinical situation. We report here the case of a 66-year-old male cirrhotic patient who developed a moderately severe clinical picture of a Coombsnegative hemolytic anemia (serum hemoglobin, 93 g/l, serum bilirubin 160.74 umol/L (9.4 mg/dl), indirect 6.3 mg/dl (107.73 umol/L); serum LDH 1220 u/l, reticulocytes, 5.1%. serum ferritin, 1221 ug/1, schistocytes in peripheral blood smear) the week after undergoing a TIPS, suggesting the development ofa microangiopathic hemolytic anaemia secondary to red blood cell disruption by passing through the metallic network of the stent. PMID:8809588

  8. New Scopes, New Accessories, New Stents for Interventional Endoscopic Ultrasound

    PubMed Central

    Chapman, Christopher G.; Siddiqui, Uzma D.

    2016-01-01

    Technological advances have rapidly expanded the therapeutic potential of endoscopic ultrasound (EUS). Innovations in stent technology; directed adjunctive therapy for pancreatic tumors, including radiofrequency ablation and fiducial marker placement; advanced imaging modalities, including needle-based confocal laser endomicroscopy; and new echoendoscopes, such as the forward-viewing linear echoendoscope, are emerging as safe and effective tools and devices for providing a broad range of treatments and therapies previously not thought possible. In this review, we summarize and discuss the new echoendoscopes, accessories, and stents for interventional EUS and highlight the recent literature on technical and therapeutic efficacy. The therapeutic role and indications for EUS are rapidly evolving well beyond its current limits as new EUS-specific designed tools are designed, and ultimately, should help achieve the goal of improving patient outcomes. PMID:26855923

  9. Carotid Artery Stenting versus Endarterectomy

    PubMed Central

    Gahremanpour, Amir; Perin, Emerson C.; Silva, Guilherme

    2012-01-01

    For about 2 decades, investigators have been comparing carotid endarterectomy with carotid artery stenting in regard to their effectiveness and safety in treating carotid artery stenosis. We conducted a systematic review to summarize and appraise the available evidence provided by randomized trials, meta-analyses, and registries comparing the clinical outcomes of the 2 procedures. We searched the MEDLINE, SciVerse Scopus, and Cochrane databases and the bibliographies of pertinent textbooks and articles to identify these studies. The results of clinical trials and, consequently, the meta-analyses of those trials produced conflicting results regarding the comparative effectiveness and safety of carotid endarterectomy and carotid stenting. These conflicting results arose because of differences in patient population, trial design, outcome measures, and variability among centers in the endovascular devices used and in operator skills. Careful appraisal of the trials and meta-analyses, particularly the most recent and largest National Institutes of Healthsponsored trial (the Carotid Revascularization Endarterectomy vs Stenting Trial [CREST]), showed that carotid stenting and endarterectomy were associated with similar rates of death and disabling stroke. Within the 30-day periprocedural period, carotid stenting was associated with higher risks of stroke, especially for patients aged >70 years, whereas carotid endarterectomy was associated with a higher risk of myocardial infarction. The slightly higher cost of stenting compared with endarterectomy was within an acceptable range by cost-effectiveness standards. We conclude that carotid artery stenting is an equivalent alternative to carotid endarterectomy when patient age and anatomy, surgical risk, and operator experience are considered in the choice of treatment approach. PMID:22949763

  10. Impact of Stent Design on In-Stent Stenosis in a Rabbit Iliac Artery Model

    SciTech Connect

    Sommer, C. M. Grenacher, L.; Stampfl, U.; Arnegger, F. U.; Rehnitz, C.; Thierjung, H.; Stampfl, S.; Berger, I.; Richter, G. M.; Kauczor, H. U.; Radeleff, B. A.

    2010-06-15

    The purpose of this study was to evaluate the impact of stent design on in-stent stenosis in rabbit iliac arteries. Four different types of stent were implanted in rabbit iliac arteries, being different in stent design (crown or wave) and strut thickness (50 or 100 {mu}m). Ten stents of each type were implanted. Each animal received one crown and one wave stent with the same strut thickness. Follow-up was either 12 weeks (n = 10 rabbits) or 24 weeks (n = 10 rabbits). Primary study end points were angiographic and microscopic in-stent stenosis. Secondary study end points were vessel injury, vascular inflammation, and stent endothelialization. Average stent diameter, relative stent overdilation, average and minimal luminal diameter, and relative average and maximum luminal loss were not significantly different. However, a trend to higher relative stent overdilation was recognized in crown stents compared to wave stents. A trend toward higher average and minimal luminal diameter and lower relative average and maximum luminal loss was recognized in crown stents compared to wave stents with a strut thickness of 100 {mu}m. Neointimal height, relative luminal area stenosis, injury score, inflammation score, and endothelialization score were not significantly different. However, a trend toward higher neointimal height was recognized in crown stents compared to wave stents with a strut thickness of 50 {mu}m and a follow-up of 24 weeks. In conclusion, in this study, crown stents seem to trigger neointima. However, the optimized radial force might equalize the theoretically higher tendency for restenosis in crown stents. In this context, also more favorable positive remodeling in crown stents could be important.

  11. Late stent thrombosis after implantation of a sirolimus-eluting stent.

    PubMed

    Kerner, Arthur; Gruberg, Luis; Kapeliovich, Michael; Grenadier, Ehud

    2003-12-01

    Late stent thrombosis in the era of routine high-pressure stent deployment and combined antiplatelet therapy with thienopyridines and aspirin has become a rare but feared complication. We describe a patient with acute myocardial infarction due to late stent thrombosis 6 weeks after deployment of a sirolimus-eluting stent and 2 weeks after the discontinuation of clopidogrel. This is the first report of late thrombosis of a sirolimus-eluting stent.

  12. Fluid mechanics in stented arterial model

    NASA Astrophysics Data System (ADS)

    Bernad, S. I.; Totorean, A.; Bosioc, A.; Crainic, N.; Hudrea, C.; Bernad, E. S.

    2015-12-01

    Local hemodynamic factors are known affect the natural history of the restenosis critically after coronary stenting of atherosclerosis. Stent-induced flows disturbance magnitude dependent directly on the strut design. Strut shape, strut thickness and the distance between consecutive struts have been associated clinically with the with post-intervention clinical outcomes. Hemodynamically favorable designs according to computational modeling can reduced in-stent restenosis after coronary stenting intervention.

  13. Stent Angioplasty of Closed Mesocaval Shunt in a Patient with Budd-Chiari Syndrome

    SciTech Connect

    Sancak, Tanzer; Karagulle, Ayse Tuba; Bilgic, Sadik; Sanlidilek, Umman; Yerdel, Mehmet Ali

    2002-08-15

    Budd-Chiari syndrome (BCS) is an uncommon disorder caused by hepatic venous outflow obstruction. It is characterized by ascites, hepatomegaly and abdominal pain. Percutaneous intervention shave recently been used for the treatment of BCS. We present a case of BCS with a closed mesocaval shunt which was reopened with a self-expandable metallic stent.

  14. Noncovered Stent Placement in a Blunt Traumatic Injury of the Right Subclavian Artery

    SciTech Connect

    D'Othee, Bertrand Janne; Rousseau, Herve; Otal, Philippe; Joffre, Francis

    1999-09-15

    We report a case of scapulothoracic dissociation with right subclavian artery traumatic injury that was managed by endovascular treatment. Particular features are the use of a flexible self-expandable noncovered stent and simultaneous protection of the right common carotid artery from distal embolization by inflating a balloon catheter.

  15. Percutaneous Endovascular Stent-Graft for Iliac Pseudoaneurysm Following Lumbar Discectomy

    SciTech Connect

    Hong, Seong J.; Oh, Joo H.; Yoon, Yup

    2000-11-15

    In a 24-year-old woman, an iliac pseudoaneurysm following lumbar discectomy was successfully treated by percutaneous placement of a self-expanding stent-graft. A postprocedural angiogram demonstrated complete exclusion of the pseudoaneurysm without leakage of contrast agent.

  16. Arsenic contamination of coarse-grained and nanostructured nitinol surfaces induced by chemical treatment in hydrofluoric acid.

    PubMed

    Korotin, D M; Bartkowski, S; Kurmaev, E Z; Borchers, C; Müller, M; Neumann, M; Gunderov, D V; Valiev, R Z; Cholakh, S O

    2012-10-01

    XPS measurements of coarse-grained and nanostructured nitinol (Ni(50.2)Ti(49.8)) before and after chemical treatment in hydrofluoric acid (40% HF, 1 min) are presented. The nanostructured state, providing the excellent mechanical properties of nitinol, is achieved by severe plastic deformation. The near-surface layers of nitinol were studied by XPS depth profiling. According to the obtained results, a chemical treatment in hydrofluoric acid reduces the thickness of the protective TiO(2) oxide layer and induces a nickel release from the nitinol surface and an arsenic contamination, and can therefore not be recommended as conditioning to increase the roughness of NiTi-implants. A detailed evaluation of the resulting toxicological risks is given.

  17. What to Expect After a Stent Procedure

    MedlinePlus

    ... insertion site Common Precautions After a Stent Procedure Blood Clotting Precautions After a stent procedure, your doctor will likely recommend that you take aspirin and another anticlotting medicine. These medicines help prevent blood clots from forming in the stent. A blood ...

  18. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Vaginal stent. 884.3900 Section 884.3900 Food and... OBSTETRICAL AND GYNECOLOGICAL DEVICES Obstetrical and Gynecological Prosthetic Devices § 884.3900 Vaginal stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or...

  19. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Vaginal stent. 884.3900 Section 884.3900 Food and... OBSTETRICAL AND GYNECOLOGICAL DEVICES Obstetrical and Gynecological Prosthetic Devices § 884.3900 Vaginal stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or...

  20. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vaginal stent. 884.3900 Section 884.3900 Food and... OBSTETRICAL AND GYNECOLOGICAL DEVICES Obstetrical and Gynecological Prosthetic Devices § 884.3900 Vaginal stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or...

  1. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vaginal stent. 884.3900 Section 884.3900 Food and... OBSTETRICAL AND GYNECOLOGICAL DEVICES Obstetrical and Gynecological Prosthetic Devices § 884.3900 Vaginal stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or...

  2. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vaginal stent. 884.3900 Section 884.3900 Food and... OBSTETRICAL AND GYNECOLOGICAL DEVICES Obstetrical and Gynecological Prosthetic Devices § 884.3900 Vaginal stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or...

  3. Refining stent technologies for femoral interventions.

    PubMed

    Bosiers, M; Deloose, K; Callaert, J; Maene, L; Keirse, K; Verbist, J; Peeters, P

    2012-08-01

    Stents were created as a mechanical scaffold to prevent vessel recoil and luminal renarrowing after percutaneous transluminal angioplasty (PTA). In femoropopliteal arteries, indication for stent implantation remains a topic much debated on, especially in long lesion configurations. Ever since the first stents were introduced on the market, in-stent restenosis (ISR) has been an important issue. The evolution in stent design has known a major progression in the last decades from the first generation of stents, plagued with high fracture rates and low primary patency rates, to the design of newer stents to tackle these outcomes. More flexible and longer stents decreased the high fracture rates and drug-eluting stents offered a solution to the restenosis rates by local drug application. The difficult recrossibility of the lesion because of the presence of a permanent vascular scaffold is an obstacle that the drug-coated balloon (DCB) overcomes. Future perspectives in the treatment of femoropopliteal lesions are found in the bioresorbable stent implantation. The bioresorbable stent combines the advantages of a drug-eluting scaffolding stent without the remainder of a foreign object in the long-term. Further investigations in this area will eventually evolve in the creation of a superior endovascular treatment modality with high long-term patency rates and minimal detriments.

  4. The need for stent-lesion matching to optimize outcomes of intracoronary stent implantation.

    PubMed

    Lanzer, Peter; Strupp, Gerhard; Schmidt, Wolfram; Topoleski, L D Timmie

    2013-11-01

    Intracoronary stents have markedly improved the outcomes of catheter-based coronary interventions. Intracoronary stent implantation rates of over 90% during coronary angioplasty are common. Stent implantations are associated with a small but statistically significant number of adverse outcomes including restenosis, thrombosis, strut malapposition, incomplete strut endothelialization, and various types of stenting failure. Better matching of biomechanical properties of stents and lesions could further improve the clinical outcome of intracoronary stenting. Thus, in this article, we assess the need for advanced intracoronary stent-lesion matching. We reviewed the data on biomechanics of coronary stents and lesions to develop knowledge-based rationale for optimum intracoronary stent selection. The available technical information on marketed intracoronary stents and the current understanding of the biomechanical properties of coronary lesions at rest and under stress are limited, preventing the development of knowledge-based rationale for optimum intracoronary stent selection at present. Development of knowledge-based selection of intracoronary stents requires standardization of mechanical stent testing, communication of the nonproprietary technical data on stents by the industry and dedicated research into procedural stent-lesion interactions.

  5. Stenting of the arterial duct: a new approach to palliation for pulmonary atresia.

    PubMed Central

    Gibbs, J L; Rothman, M T; Rees, M R; Parsons, J M; Blackburn, M E; Ruiz, C E

    1992-01-01

    OBJECTIVE--To assess the possibility of maintaining ductal patency in neonates with complex pulmonary atresia by percutaneous implantation of balloon expandable stents. PATIENTS--Two duct-dependent neonates with long segment pulmonary atresia, right sided aortic arch, and left sided arterial duct. RESULTS--Stents with final diameter of 3.5 or 4 mm and initial length of 7 or 15 mm were successfully positioned in the arterial duct. Two stents were required in one child and four in the other in order to stent the entire length of the duct. After the procedures the ducts remained widely patent and arterial oxygen saturations remained above 80%. Complications of the procedures included perforation of a peripheral pulmonary artery and cardiac perforation, both caused by guide wire manipulation. Both babies died suddenly, one at five weeks, and the other at nine days after successful stenting of the duct. Both ducts were patent at necropsy; the exact cause of one death was not clearly defined, but the second seemed to be caused by pneumococcal septicaemia. CONCLUSIONS--Stenting of the arterial duct is technically feasible. It provides adequate palliation for neonates with pulmonary atresia at least in the short term and it seems to result in balanced, central perfusion of both pulmonary arteries. This preliminary report suggests that this previously untried technique may prove to be a promising and attractive alternative to neonatal aortopulmonary shunt operation. Images PMID:1372815

  6. Biodegradable stents: they do their job and disappear.

    PubMed

    Waksman, Ron

    2006-02-01

    Despite the development and progression of metallic stents, many concerns still remain because of their permanent nature. Although metallic stents are effective in preventing recoil and late restenosis after coronary angioplasty, they continue to have limitations such as stent thrombosis and mismatch of the stent to the vessel size. Thus, the concept of bioabsorbable stents has emerged as an alternative to permanent metal stents. This review will outline concepts, material designs, preclinical, and initial clinical experimental studies with bioabsorbable stents.

  7. Enhancing Stent Effectiveness with Nanofeatures

    PubMed Central

    Bassous, Nicole; Cooke, John P.; Webster, Thomas J.

    2016-01-01

    Drug-eluting stents are an effective therapy for symptomatic arterial obstructions, substantially reducing the incidence of restenosis by suppressing the migration and proliferation of vascular smooth muscle cells into the intima. However, current drug-eluting stents also inhibit the growth of endothelial cells, which are required to cover the vascular stent to reduce an excessive inflammatory response. As a result, the endothelial lining of the lumen is not regenerated. Since the loss of this homeostatic monolayer increases the risk of thrombosis, patients with drug-eluting stents require long-term antithrombotic therapy. Thus, there is a need for improved devices with enhanced effectiveness and physiological compatibility towards endothelial cells. Current developments in nanomaterials may enhance the function of commercially available vascular devices. In particular, modified design schemes might incorporate nanopatterns or nanoparticle-eluting features that reduce restenosis and enhance re-endothelialization. The intent of this review is to discuss emerging nanotechnologies that will improve the performance of vascular stents. PMID:27826371

  8. The effect of paclitaxel-eluting covered metal stents versus covered metal stents in a rabbit esophageal squamous carcinoma model

    PubMed Central

    Zhang, Yin; Ma, Limei; Huang, Jin; Shuang, Jinquan

    2017-01-01

    Background The use of self-expanding metallic stents (SEMSs) is the current treatment of choice for malignant gastrointestinal obstructions. However, these stents can promote only drainage and have no antitumor effect. Some studies have reported that drug-eluting SEMSs may have tumor inhibition potential. The aim of this study was to evaluate the efficiency and safety of paclitaxel-eluting SEMSs (PEMSs) in rabbit esophageal cancer models. Materials and methods A PEMS was covered with a paclitaxel-incorporated membrane, in which the concentration of paclitaxel was 10% (wt/vol). The rabbit models were created endoscopically. Then, a PEMS or SEMS was endoscopically inserted into the rabbit esophagus. Two weeks after stent placement, the rabbits were sacrificed, and we evaluated the tumor volume, area of the wall defect, area of the tumor under endoscopic ultrasound (EUS) before and after stent placement, status of the proximal esophageal obstruction, tumor metastasis food-intake and weight loss. Results A total of 26 rabbits received stent insertion and survived until sacrifice, and migration occurred in 4 cases, 3 in SEMS group and 1 in PEMS group. For the remaining 22 rabbits, at the sacrificed time, the average tumor volume was 7.00±4.30 cm3 in the SEMS group and 0.94±1.51 cm3 in the PEMS group (P<0.05). The area of the esophageal wall defect was 0.70±0.63 cm2 in the SEMS group and 0.17±0.16 cm2 in the PEMS group (P<0.05). The tumor area under EUS was 4.40±1.47 cm2 in the SEMS group and 1.30±1.06 cm2 in the PEMS group (P<0.05). At the time of stent placement, tumor area under EUS was comparable in the two groups. Other indices did not significantly differ between the two groups. Conclusions SEMS and PEMS are both safe and effective to relieve dysphagia in rabbit esophageal cancer models. A PEMS can serve as an alternative tool for advanced esophageal cancer that may inhibit tumor growth by serving as a drug sustained-release platform. Clinical trials of the

  9. An Assessment of Radiologically Inserted Transoral and Transgastric Gastroduodenal Stents to Treat Malignant Gastric Outlet Obstruction

    SciTech Connect

    Miller, Bethany H. T.; Griffiths, Ewen A.; Pursnani, Kishore G. Ward, Jeremy B.; Stockwell, Robert C.

    2013-12-15

    IntroductionSelf-expanding metallic stents (SEMS) are used to palliate malignant gastric outlet obstruction (GOO) and are useful in patients with limited life expectancy or severe medical comorbidity, which would preclude surgery. Stenting can be performed transorally or by a percutaneous transgastric technique. Our goal was to review the outcome of patients who underwent radiological SEMS insertion performed by a single consultant interventional radiologist. Methods: Patients were identified from a prospectively collected database held by one consultant radiologist. Data were retrieved from radiological reports, multidisciplinary team meetings, and the patients' case notes. Univariate survival analysis was performed. Results: Between December 2000 and January 2011, 100 patients (63 males, 37 females) had 110 gastroduodenal stenting procedures. Median age was 73 (range 39-89) years. SEMS were inserted transorally (n = 66) or transgastrically (n = 44). Site of obstruction was the stomach (n = 37), duodenum (n = 50), gastric pull-up (n = 10), or gastroenterostomy (n = 13). Seven patients required biliary stents. Technical success was 86.4 %: 83.3 % for transoral insertion, 90.9 % for transgastric insertion. Eleven patients developed complications. Median GOO severity score: 1 pre-stenting, 2 post-stenting (p = 0.0001). Median survival was 54 (range 1-624) days. Post-stenting GOO severity score was predictive of survival (p = 0.0001). Conclusions: The technical success rate for insertion of palliative SEMS is high. Insertional technique can be tailored to the individual depending on the location of the tumor and whether it is possible to access the stomach percutaneously. Patients who have successful stenting and return to eating a soft/normal diet have a statistically significant increase in survival.

  10. Local Angiopeptin Delivery Using Coated Stents Reduces Neointimal Proliferation in Overstretched Porcine Coronary Arteries.

    PubMed

    De Scheerder I; Wilczek; Van Dorpe J; Verbeken; Cathapermal; Wang; Desmet; Schacht; Foegh; De Geest H; Piessens

    1996-06-01

    BACKGROUND: Systemic administration of angiopeptin has been shown to inhibit myointimal thickening after arterial injury in several animal species. METHODS AND RESULTS: To explore to what extent high and long-lasting local concentrations of angiopeptin influence the healing process after vascular injury, tantalum balloon-expandable stents were first coated with a polymer loaded with angiopeptin 250 µg. Implantation of these stents in porcine coronary arteries resulted in tissue concentrations of 10.7 pg/ml wet weight in the stented arterial segment 24 hours after stent implantation, gradually declining to 2.0 pg/ml wet weight at day 8. Finally, 20 pigs were randomly treated with either an angiopeptin-loaded or a blank-coated stent. At baseline, the angiographic parameters were similar between both groups but, after 6 weeks, the minimal luminal diameter of the stented arterial segment was larger in the angiopeptin-treated pigs when compared to controls (2.20 +/- 0.57 mm vs 1.57 +/- 0.68 mm, p < 0.01) This angiographic finding was confirmed by post-mortem morphometry where the respective lumen area values were 1.00 +/- 0.54 mm2 and 0.43 +/- 0.28 mm2 (p < 0.01). CONCLUSION: Polymer coated stents can be loaded with angiopeptin, which after implantation in porcine right coronary arteries result in high local tissue concentrations gradually declining over more than 8 days. These high local concentrations inhibit myointimal proliferation induced by poly(organo)phosphazene coated overstretched stents.

  11. Influence of sodium hypochlorite treatment of electropolished and magnetoelectropolished nitinol surfaces on adhesion and proliferation of MC3T3 pre-osteoblast cells.

    PubMed

    Rokicki, Ryszard; Haider, Waseem; Hryniewicz, Tadeusz

    2012-09-01

    The influence of 6 % sodium hypochlorite (NaClO) treatment on adhesion and proliferation of MC3T3 pre-osteoblast cells seeded on electropolished (EP) and magnetoelectropolished (MEP) nitinol surfaces were investigated. The chemistry, topography, roughness, surface energy, wettability of EP and MEP nitinol surfaces before and after NaClO treatment were studied with X-ray photoelectron spectroscopy (XPS), profilometry, and contact angle meter. In vitro interaction of osteoblast cell and NaClO treated EP and MEP nitinol surfaces were assessed after 3 days of incubation by scanning electron microscopy. The XPS analysis shows that NaClO treatment increases oxygen content especially in subsurface oxide layer of EP and MEP nitinol. The changes of both basic components of nitinol, namely nickel and titanium in oxide layer, were negligible. The NaClO treatment did not influence physico-morphological surface properties of EP and MEP nitinol to a big extent. The osteoblast cells show remarkable adherence and proliferation improvement on NaClO treated EP and MEP nitinol surfaces. After 3 days of incubation they show almost total confluence on both NaClO treated surfaces. The present study shows that NaClO treatment of EP and MEP nitinol surfaces alters oxide layer by enriching it in oxygen and by this improves bone cell-nitinol interaction.

  12. Intra-channel stent release technique for fluoroless endoscopic ultrasound-guided lumen-apposing metal stent placement: changing the paradigm

    PubMed Central

    Anderloni, Andrea; Attili, Fabia; Carrara, Silvia; Galasso, Domenico; Di Leo, Milena; Costamagna, Guido; Repici, Alessandro; Kunda, Rastislav; Larghi, Alberto

    2017-01-01

    Background Recently, a novel lumen-apposing fully covered self-expanding metal stent (LA-FCSEMS) mounted on an electrocautery-enhanced delivery system has been developed to perform endoscopic ultrasound (EUS)-guided transluminal drainage. From early experience, however, release of the proximal flange of the stent has mostly been done using endoscopic view guidance to ensure proper positioning. Aim We describe a new technique that we have named the Intra-Channel Stent Release Technique (ICSRT) to perform stent placement under complete EUS control, without the use of either fluoroscopic or endoscopic views. Material and methods Data on all consecutive patients who underwent EUS-guided drainage using the new ICSRT between June 2014 and April 2016 were retrospectively retrieved from two institution databases. All EUS procedures were performed by experienced endoscopists with the patient under conscious or deep sedation. The total procedure and stent deployment time, and adverse events related to stent positioning with the ICSRT were evaluated. Results One hundred consecutive patients (51 women; mean age ± SD, 66 ± 15.2 years, range 34 – 95) underwent EUS-guided transluminal drainage with the Hot AXIOS™ device using the new ICSRT. The procedure was technically successful in all but one patient (1 %). The mean total procedural time was 21.9 minutes (range 7 – 50), while the mean time for stent placement was 3.2 minutes (range 1 – 15). No major adverse events occurred. Discussion The ICSRT has been used to deploy the newly developed lumen-apposing FCSEMS under complete EUS guidance without fluoroscopic and/or endoscopic assistance. The technique appears to be safe and highly effective and should be learned by all interventional endosonographers in order to be able to perform drainage in all clinical scenarios.

  13. Advances in helical stent design and fabrication thermal treatment and structural interaction studies of the simulated plaque-laden artery

    NASA Astrophysics Data System (ADS)

    Welch, Tre Raymond

    Advancements in processing biomaterials have lead to the development of bioresorbable PLLA drug-loaded stents with different geometric configurations. To further advance the technology, systematic studies have been carried out. This dissertation consists of five specific aims: (1) To characterize the effects of thermal annealing on the mechanical characteristics of PLLA helical stent, (2) To characterize the mechanical characteristics of a PLLA double helix stent, (3) To characterize the physical and chemical properties of PLLA films impregnated with niacin and curcumin, (4) To characterize the mechanical interaction of expanded stent and vascular wall with both model simulation and experimental studies using PDMS phantom arteries, (5) To simulate the stent-plaque-artery interactions using computer models. Results and their significances in bioresorbable PLLA drug-loaded stents technology as well as clinical prospects will be presented. For Aim1, thermal annealing is shown to improve mechanical characteristics of the helical stent, including pressure-diameter response curves, incremental stiffness, and collapse pressure. Differential scanning calorimetric analysis of stent fiber reveals that thermal annealing contribute to increased percent crystallinity, thus enhanced mechanical characteristics of the stent. For Aim 2, the new double helix design was shown to leads to improved mechanical characteristics of stent, including pressure-diameter response curves, incremental stiffness, and collapse pressure. Further, it was found to lead to an increased percent crystallinity and reduced degradation rate. For Aim 3, the changes in mechanical properties, crystallinity in PLLA polymer loaded with curcumin, or niacin, or both from that of control are clearly delineated. Results from Aim 4 shed lights on the mechanical disturbance in the vicinity of deployed stent and vascular wall as well as the abnormal shear stresses on the vascular endothelium. Their implications in

  14. [Absorbable coronary stents. New promising technology].

    PubMed

    Erbel, Raimund; Böse, Dirk; Haude, Michael; Kordish, Igor; Churzidze, Sofia; Malyar, Nasser; Konorza, Thomas; Sack, Stefan

    2007-06-01

    Coronary stent implantation started in Germany 20 years ago. In the beginning, the progress was very slow and accelerated 10 years later. Meanwhile, coronary stent implantation is a standard procedure in interventional cardiology. From the beginning of permanent stent implantation, research started to provide temporary stenting of coronary arteries, first with catheter-based systems, later with stent-alone technology. Stents were produced from polymers or metal. The first polymer stent implantation failed except the Igaki-Tamai stent in Japan. Newly developed absorbable polymer stents seem to be very promising, as intravascular ultrasound (IVUS) and optical coherence tomography have demonstrated. Temporary metal stents were developed based on iron and magnesium. Currently, the iron stent is tested in peripheral arteries. The absorbable magnesium stent (Biotronik, Berlin, Germany) was tested in peripheral arteries below the knee and meanwhile in the multicenter international PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting with Absorbable Metal Stents) study. The first magnesium stent implantation was performed on July 30, 2004 after extended experimental testing in Essen. The magnesium stent behaved like a bare-metal stent with low recoil of 5-7%. The stent struts were absorbed when tested with IVUS. Stent struts were not visible by fluoroscopy or computed tomography (CT) as well as magnetic resonance imaging (MRI). That means, that the magnesium stent is invisible and therefore CT and MRI can be used for imaging of interventions. Only using micro-CT the stent struts were visible. The absorption process could be demonstrated in a patient 18 days after implantation due to suspected acute coronary syndrome, which was excluded. IVUS showed a nice open lumen. Stent struts were no longer visible, but replaced by tissue indicating the previous stent location. Coronary angiography after 4 months showed an ischemia-driven target lesion

  15. Drug eluting biliary stents to decrease stent failure rates: A review of the literature

    PubMed Central

    Shatzel, Joseph; Kim, Jisoo; Sampath, Kartik; Syed, Sharjeel; Saad, Jennifer; Hussain, Zilla H; Mody, Kabir; Pipas, J Marc; Gordon, Stuart; Gardner, Timothy; Rothstein, Richard I

    2016-01-01

    Biliary stenting is clinically effective in relieving both malignant and non-malignant obstructions. However, there are high failure rates associated with tumor ingrowth and epithelial overgrowth as well as internally from biofilm development and subsequent clogging. Within the last decade, the use of prophylactic drug eluting stents as a means to reduce stent failure has been investigated. In this review we provide an overview of the current research on drug eluting biliary stents. While there is limited human trial data regarding the clinical benefit of drug eluting biliary stents in preventing stent obstruction, recent research suggests promise regarding their safety and potential efficacy. PMID:26839648

  16. Renal Artery Stent Placement Complicated by Development of a Type B Aortic Dissection

    SciTech Connect

    Haesemeyer, Scott W.; Vedantham, Suresh Braverman, Alan

    2005-01-15

    Percutaneous renal artery angioplasty and stent placement have demonstrated safety and effectiveness in the treatment of selected patients with renovascular hypertension and ischemic nephropathy. Major complications have been predominantly confined to the affected renal artery and kidneys, including renal artery dissection and/or thrombosis, distal embolization, and contrast-related nephropathy. We report a case in which treatment of an ostial renal artery lesion with placement of a balloon-expandable stent was complicated by the development of an acute Type B aortic dissection.

  17. The use of flow diverter stents in the management of traumatic vertebral artery dissections.

    PubMed

    Cohen, José E; Gomori, John M; Moscovici, Samuel; Bala, Miklosh; Itshayek, Eyal

    2013-05-01

    Flow diverters constitute a new generation of flexible self-expanding stent-like devices with a high metal-surface area coverage, specifically designed for the endovascular management of complex cerebral aneurysms. Recently, other potential applications for these devices in the field of occlusive cerebrovascular disease have been described. In vertebral artery dissections causing occlusion associated with a burden of extensive clots, we have found that the reduced porosity of the diverter mesh serves as an effective barrier to in-stent clot protrusion and distal embolization. We describe the novel use of a flow diverter for the management of an occlusive traumatic vertebral artery dissection. Diverter implantation allowed subsequent angioplasty.

  18. The alloy with a memory, 55-Nitinol: Its physical metallurgy, properties, and applications

    NASA Technical Reports Server (NTRS)

    Jackson, C. M.; Wagner, H. J.; Wasilewski, R. J.

    1972-01-01

    A series of nickel titanium alloys (55-Nitinol), which are unique in that they possess a shape memory, are described. Components made of these materials that are altered in their shapes by deformation under proper conditions return to predetermined shapes when they are heated to the proper temperature range. The shape memory, together with the force exerted and the ability of the material to do mechanical work as it returns to its predetermined shape, suggest a wide variety of industrial applications for the alloy. Also included are discussions of the physical metallurgy and the mechanical, physical, and chemical properties of 55-Nitinol; procedures for melting and processing the material into useful shapes; and a summary of applications.

  19. Improved biocompatibility of thrombo-resistant iron-polysaccharides multilayer coatings on nitinols.

    PubMed

    Ma, Yan; Liu, Meng; Yue, Xiuli; Zha, Zhengbao; Dai, Zhifei

    2010-01-01

    Biocompatibility of two multilayer coatings of (Fe3+/Hep)10 and (Fe3+/DS/Fe3+/Hep)5 was comparatively analyzed with respect to protein adsorption, leukocyte adhesion and cell-material interaction. Both of them showed significantly high albumin-to-fibrinogen adsorption ratio, suggesting good biocompatibility. Furthermore, the (Fe3+/DS/Fe3+/Hep)5 coating was found to exhibit the lowest non-specific protein adsorption due to the incorporation of dextran sulfate. Compared with uncoated Nitinol surfaces, iron-polysaccharide multilayer coating presented no deformation of leukocytes, indicating no signs of inflammatory reactions. Cell growth, cell adhesion and cell metabolic activity were all in good condition, verifying both (Fe3+/Hep)10 and (Fe3+/DS/Fe3+/Hep)5 coatings had good cytocompatibility. Therefore, iron-polysaccharides multilayer coatings had greatly improved the biocompatibility of Nitinols.

  20. Comparison of a New Polytetrafluoroethylene-Covered Metallic Stent to a Noncovered Stent in Canine Ureters

    SciTech Connect

    Chung, Hwan-Hoon Lee, Seung Hwa; Cho, Sung Bum; Park, Hong Suk; Kim, Young Sik; Kang, Byung Chul; Frisoli, Joan K.; Razavi, Mahmood K.

    2008-05-15

    The aim of this study was to determine the feasibility of using a newly designed polytetrafluoroethylene (PTFE)-covered metallic stent in the ureter by comparing its effectiveness with that of the noncovered stent in a canine model. We placed 14 stents in the ureters of seven mongrel dogs that weighed 30-40 kg each. The covered and noncovered stents were deployed in the right and left ureters, respectively, of six dogs. In the seventh dog, a covered stent and a double-J catheter were inserted in the right ureter, and a covered stent only was inserted in the left ureter. The first six dogs were sacrificed at 5, 10, and 15 weeks after deployment of the stents (two for each follow-up period), and the seventh dog was sacrificed at 30 weeks. There was no migration or poor expansion of any of the stents observed on plain radiography. On intravenous pyelogram and retrograde pyelogram, all of the covered stents at each follow-up period had patent lumens at the stented segments without hydronephrosis, and the passage of contrast material through it was well preserved. The noncovered stents in the dogs sacrificed at 5 and 10 weeks and one of the two dogs sacrificed at 15 weeks showed near-complete occlusion of the stent lumen due to ingrowth of the soft tissue, and severe hydronephrosis was also noted. The noncovered stent in the other dog sacrificed at 15 weeks showed the passage of contrast material without hydronephrosis, but the lumen of the stent was still nearly occluded by the soft tissue. There was no evidence of hydronephrosis or passage disturbance of the contrast material in both ureters of the dog sacrificed at 30 weeks. We conclude that the newly designed PTFE-covered stent effectively prevented the luminal occlusion caused by urothelial hyperplasia compared to the near-total occlusion of the noncovered stents, and no migration of the covered stents was noted.

  1. Stents in patients with esophageal cancer before chemoradiotherapy: high risk of complications and no impact on the nutritional status.

    PubMed

    Mão-de-Ferro, S; Serrano, M; Ferreira, S; Rosa, I; Lage, P; Alexandre, D P; Freire, J; Mirones, L; Casaca, R; Bettencourt, A; Pereira, A D

    2016-03-01

    Preoperative chemoradiotherapy is the standard of care for locally advanced esophageal cancer, causing persistent deterioration in the nutritional status. We performed a prospective study to evaluate the safety and efficacy of esophageal double-covered self-expandable metal stents in patients with esophageal cancer before chemoradiotherapy. The nutritional status and dysphagia were prospectively recorded. Eleven patients were included: eight were moderate and three were severely malnourished. After stent placement, dysphagia improved in all patients. With regard to complications, one patient developed an esophageal perforation that required urgent esophagectomy. Four patients presented stent migration. Three of these patients required enteral nutrition and none was submitted to surgery because of poor nutritional status. Of the other six patients, only four were operated upon. Stent placement presented a high complication rate and did not prevent weight loss or malnutrition. Other alternatives, including naso-gastric tube placement or endoscopic percutaneous gastrostomy or jejunostomy, should be considered.

  2. Hypothermia Severely Effects Performance of Nitinol-Based Endovascular Grafts In Vitro

    PubMed Central

    Robich, Michael P.; Hagberg, Robert; Schermerhorn, Marc L.; Pomposelli, Frank B.; Nilson, Michael C.; Gendron, Michelle L.; Sellke, Frank W.; Rodriguez, Roberto

    2012-01-01

    Background Nitinol is an alloy that serves as the base for numerous medical devices, including the GORE TAG Thoracic Endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) thoracic aortic graft device. Given the increasing use of therapeutic hypothermia used during the placement these devices and in post– cardiac arrest situations, we sought to understand the impact of hypothermia on this device. Methods Five 34-mm TAG devices were deployed in a temperature-controlled chamber at 20°C, 25°C, 30°C, 35°, and 37°C (25 total devices). A halographic measurement device was used to measure radial expansive force and normalized to the force at 37°C. Three 34-mm TAG devices were similarly deployed in a temperature-controlled water bath at each of the above temperatures. A laser micrometer was utilized to measure deployed diameter. Results A statistically significant decrease in expansive force at 20°C, 25°C, and 30°C of 65%, 46%, and 6%, respectively, was noted. A statistically significant decrease in radial diameter at 20°C and 25°C of 17% and 11%, respectively, was noted. Although a 9% difference was noted at 30°C, it was not significant. Conclusions The nitinol-based TAG device shows marked decreases in radial expansive force and deployed diameter at temperatures at or below 30°C. Surgeons should be aware of the potential implications of placing nitinol-based endoprostheses in hypothermic conditions. In addition, all health care providers should be aware of the changes that occur in nitinol-based endoprostheses during therapeutic hypothermia. PMID:22385821

  3. Cavitation Erosion of Electro Spark Deposited Nitinol vs. Stellite Alloy on Stainless Steel Substrate

    DTIC Science & Technology

    2015-07-15

    the substrate (Figure 2-2). Rapid solidification produces nano -structures with unique tribological and metallurgical characteristics. When...inventor of electro spark deposition methodology and apparatus. [18] ASAP now terms their process “ nano -fusion” and states that it is generations...stainless might be the root cause of the poor compatibility. ASAP also nano -fused Nitinol onto mild steel coupons, which produced somewhat better results

  4. Impact of bifurcation dual stenting on endothelial shear stress

    PubMed Central

    Chen, Henry Y.; Koo, Bon-Kwon

    2015-01-01

    Despite advances in percutaneous coronary interventions and the introduction of drug eluding stents, in-stent restenosis and stent thrombosis remain a clinically significant problem for bifurcations. The aim of this study is to determine the effect of dual bifurcation stenting on hemodynamic parameters known to influence restenosis and thrombosis. We hypothesized that double stenting, especially with a longer side branch (SB) stent, likely has a negative effect on wall shear stress (WSS), WSS gradient (WSSG), and oscillatory shear index (OSI). To test this hypothesis, we developed computational models of dual stents at bifurcations and non-Newtonian blood simulations. The models were then interfaced, meshed, and solved in a validated finite-element package. Longer and shorter stents at the SB and provisional stenting were compared. It was found that stents placed in the SB at a bifurcation lowered WSS, but elevated WSSG and OSI. Dual stenting with longer SB stent had the most adverse impact on SB endothelial WSS, WSSG, and OSI, with low WSS region up to 50% more than the case with shorter SB stent. The simulations also demonstrated flow disturbances resulting from SB stent struts protruding into the main flow field near the carina, which may have implications on stent thrombosis. The simulations predict a negative hemodynamic role for SB stenting, which is exaggerated with a longer stent, consistent with clinical trial findings that dual-stenting is comparable or inferior to provisional stenting. PMID:26183473

  5. FE Analysis of Nitinol Leaf Springs Used in a Compression Anastomosis Device

    NASA Astrophysics Data System (ADS)

    Weizman, Amir; Monassevitch, Leonid; Greenberg, Kobby; Millis, Shahar; Harari, Boaz; Dar, Idan

    2011-07-01

    Reconstruction of the digestive system lumen patency (anastomosis creation) after its partial surgical removal is a common and crucial procedure. The conventional anastomosis methods use devices for mechanical suturing which are associated with high failure risk and can lead to major complications. The compression anastomosis as a sutureless method seems to be a promising alternative. However, attempts during the last two centuries have not been completely successful due to the complex character of the tissue-healing process. The specific mechanical behavior of Nitinol alloys was applied to the force element of the compression devices. These devices are becoming more widely adopted in surgery practice. The compression anastomosis device enables the anastomosis of colonic and intestinal tissue based on compression forces exerted by Nitinol leaf springs. By means of changing the strain distribution in the stressed leaves with varying moments of inertia, one can gain full control of the different stages in the force-deflection profile (i.e., linear elastic stage and the force plateau stage). The target of this study is the comparison of different Nitinol leaf geometries and evaluation of the finite elements analysis as a tool for preliminary design of such geometries. The results of this analysis allow us to establish regulation of the spring's mechanical behavior, thus controlling the anastomosis creation in the compression anastomosis device.

  6. Surface, corrosion and biocompatibility aspects of Nitinol as an implant material.

    PubMed

    Shabalovskaya, Svetlana A

    2002-01-01

    The present review surveys studies on physical-chemical properties and biological response of living tissues to NiTi (Nitinol) carried out recently, aiming at an understanding of the place of this material among the implant alloys in use. Advantages of shape memory and superelasticity are analyzed in respect to functionality of implants in the body. Various approaches to surface treatment, sterilization procedures, and resulting surface conditions are analyzed. A review of corrosion studies conducted both on wrought and as-cast alloys using potentiodynamic and potentiostatic techniques in various corrosive media and in actual body fluids is also given. The parameters of localized and galvanic corrosion are presented. The corrosion behavior is analyzed with respect to alloy composition, phase state, surface treatment, and strain and compared to that of conventional implant alloys. Biocompatibility of porous Nitinol, Ni release and its effect on living cells are analyzed based on understanding of the surface conditions and corrosion behavior. Additionally, the paper offers a brief overview of the comparative toxicity of metals, components of commonly used medical alloys, indicating that the biocompatibility profile of Nitinol is conducive to present in vivo applications.

  7. Corrosion resistance, chemistry, and mechanical aspects of Nitinol surfaces formed in hydrogen peroxide solutions.

    PubMed

    Shabalovskaya, Svetlana A; Anderegg, James W; Undisz, Andreas; Rettenmayr, Markus; Rondelli, Gianni C

    2012-08-01

    Ti oxides formed naturally on Nitinol surfaces are only a few nanometers thick. To increase their thickness, heat treatments are explored. The resulting surfaces exhibit poor resistance to pitting corrosion. As an alternative approach to accelerate surface oxidation and grow thicker oxides, the exposure of Nitinol to strong oxidizing H(2)O(2) aqueous solutions (3 and 30%) for various periods of time was used. Using X-Ray Photoelectron Spectroscopy (XPS) and Auger spectroscopy, it was found that the surface layers with variable Ti (6-15 at %) and Ni (5-13 at %) contents and the thickness up to 100 nm without Ni-enriched interfaces could be formed. The response of the surface oxides to stress in superelastic regime of deformations depended on oxide thickness. In the corrosion studies performed in both strained and strain-free states using potentiodynamic and potentiostatic polarizations, the surfaces treated in H(2)O(2) showed no pitting in corrosive solution that was assigned to higher chemical homogeneity of the surfaces free of secondary phases and inclusions that assist better biocompatibility of Nitinol medical devices.

  8. An Examination of the Mechanical Behavior of Shape Memory Nitinol Wires at Various Temperatures

    NASA Astrophysics Data System (ADS)

    Rolsen, L.; Plumley, D.

    2014-07-01

    Shape memory Nitinol alloys are commonly used in a myriad of strain recovery applications. Understanding the behavior of the material at different temperatures influences the choices of the application designer when selecting different grades of Nitinol. This study focuses on six Nitinol ingot austenitic start ( A s) temperatures (Ingot A s = 95.0, 84.0, 62.3, 41.6, 29.3, and 13.4 °C). Each sample was drawn to wire diameters ranging from 0.076 to 1 mm, two sizes per ingot A s, with varying heat treatments to achieve various active austenite transformation temperatures ranges (TTR). TTR behavior was measured utilizing a linear variable displacement transducer (LVDT) bend and free recovery (BFR) method, per ASTM F2082. Mechanical characterization was determined by a series of uniaxial tensile tests performed at 5, 10, 15, 20, 30, 50, 75, and 100 °C above respective active A f transformation temperatures. This study will detail the methods utilized in determining the results and potential impact on current industry test modalities and standards.

  9. Mesenchymal stem cell proliferation and differentiation on load-bearing trabecular Nitinol scaffolds.

    PubMed

    Gotman, Irena; Ben-David, Dror; Unger, Ronald E; Böse, Thomas; Gutmanas, Elazar Y; Kirkpatrick, C James

    2013-09-01

    Bone tissue regeneration in load-bearing regions of the body requires high-strength porous scaffolds capable of supporting angiogenesis and osteogenesis. 70% porous Nitinol (NiTi) scaffolds with a regular 3-D architecture resembling trabecular bone were produced from Ni foams using an original reactive vapor infiltration technique. The "trabecular Nitinol" scaffolds possessed a high compressive strength of 79 MPa and high permeability of 6.9×10(-6) cm2. The scaffolds were further modified to produce a near Ni-free surface layer and evaluated in terms of Ni ion release and human mesenchymal stem cell (hMSC) proliferation (AlamarBlue), differentiation (alkaline phosphatase activity, ALP) and mineralization (Alizarin Red S staining). Scanning electron microscopy was employed to qualitatively corroborate the results. hMSCs were able to adhere and proliferate on both as-produced and surface-modified trabecular NiTi scaffolds, to acquire an osteoblastic phenotype and produce a mineralized extracellular matrix. Both ALP activity and mineralization were increased on porous scaffolds compared to control polystyrene plates. Experiments in a model coculture system of microvascular endothelial cells and hMSCs demonstrated the formation of prevascular structures in trabecular NiTi scaffolds. These data suggest that load-bearing trabecular Nitinol scaffolds could be effective in regenerating damaged or lost bone tissue.

  10. Utility of magneto-electropolished ternary nitinol alloys for blood contacting applications.

    PubMed

    Pulletikurthi, Chandan; Munroe, Norman; Stewart, Danique; Haider, Waseem; Amruthaluri, Sushma; Rokicki, Ryszard; Dugrot, Manuel; Ramaswamy, Sharan

    2015-10-01

    The thrombogenicity of a biomaterial is mainly dependent on its surface characteristics, which dictates its interactions with blood. Surface properties such as composition, roughness wettability, surface free energy, and morphology will affect an implant material's hemocompatibility. Additionally, in the realm of metallic biomaterials, the specific composition of the alloy and its surface treatment are important factors that will affect the surface properties. The utility of magneto-electropolished (MEP) ternary Nitinol alloys, NiTiTa, and NiTiCr as blood contacting materials was investigated. The hemcompatibility of these alloys were compared to mechanically polished (MP) metallic biomaterial counterparts. In vitro thrombogenicity tests revealed significantly less platelet adherence on ternary MEP Nitinol, especially MEP NiTi10Ta as compared to the MP metals (p < 0.05). The enhanced anti-platelet-adhesive property of MEP NiTi10Ta was in part, attributed to the Ta2 O5 component of the alloy. Furthermore, the formation of a dense and mixed hydrophobic oxide layer during MEP is believed to have inhibited the adhesion of negatively charged platelets. In conclusion, MEP ternary Nitinol alloys can potentially be utilized for blood-contacting devices where, complications resulting from thrombogenicity can be minimized.

  11. Drug-Eluting Stents: Do They Increase Heart Attack Risk?

    MedlinePlus

    ... intervention, or PCI). Drug-eluting stents have a polymer coating over mesh that emits a drug over ... 2014. Bangalore S, et al. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting ...

  12. One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial

    PubMed Central

    van Hout, B A; Serruys, P W; Lemos, P A; van den Brand, M J B M; Es, G-A van; Lindeboom, W K; Morice, M-C

    2005-01-01

    Objective: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study. Design: Multicentre, double blind, randomised trial Setting: Percutaneous coronary intervention for single de novo coronary lesions Patients: 238 patients with stable or unstable angina. Interventions: Randomisation to sirolimus eluting stent or bare stent implantation. Main outcome measures: Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs. Results: At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of €1286. At one year, however, the estimated additional cost difference had decreased to €54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the additional one year costs at €166. Conclusions: The one year data from RAVEL suggest an attractive balance between costs and effects for sirolimus eluting stents in the treatment of single native de novo coronary lesions. The cost effectiveness of drug eluting stents in more complex lesion subsets remains to be determined. PMID:15772214

  13. Assessment of contrast flow modification in aneurysms treated with closed-cell self-deploying asymmetric vascular stents (SAVS)

    NASA Astrophysics Data System (ADS)

    Ionita, Ciprian N.; Wang, Weiyuan; Bednarek, Daniel R.; Rudin, Stephen

    2010-03-01

    The Asymmetric Vascular Stent (AVS) for intracranial aneurysm (IA) treatment is an experimental device, specially designed for intra-aneurysmal blood flow diversion and thrombosis promotion. The stent has a low-porous patch to cover only the aneurysm neck while the rest of the stent is very porous to avoid blockage of adjacent branches. The latest AVS design is similar to state-of-art, closed-cell, self-expanding, neurovascular stent. The stents were used to treat sixteen rabbit-elastase aneurysm models. The treatment effect was analyzed using normalized-time-density-curves (NTDC) measured by pixel-value integration over a region-of-interest containing the aneurysm. Normalization constant was the total bolus injection determined angiographically. Based on NTDC measurement, five quantities were derived to describe the contrast flow. Two are related to the amount of contrast entering the aneurysm: NTDC peak and NTDC input slope. The other three are related to contrast presence in the aneurysmal dome: time-to-peak (TTP), wash-out-time (WOT) and mean-transit-time (MTT). Flow modification descriptions using the contrast related quantities were expressed as a pre-/post-stented NTDC parameter ratio, while the time related quantities were expressed as a post-/prestented ratio, so that ratios smaller than one indicate a desired effect. Thirteen aneurysms were treated successfully and achieved significant aneurysm occlusion. For these cases, the resulting average parameters were: peak-ratio=0.17+0.21; input-slope-ratio=0.19+/-0.24, TTP-ratio=0.17+0.21, WOT-ratio=0.58+/-0.73 and MTT-ratio=0.65+/-0.97). All the quantities revealed decreased aneurysmal flow due to blood flow diversion using the new self-expanding asymmetrical vascular stent (SAVS). Treatment outcome results and angiographic analysis indicate that the new self-deploying stent design has great potential for clinical implementation.

  14. The Use of Prosthetic Stents in Tracheobronchial, Gastrointestinal, and Genitourinary Diseases

    PubMed Central

    Hughes, Rollin W.; Oesterling, Joseph E.; Cortese, Denis A.

    1994-01-01

    The concept of using a stent to maintain patency of a lumen is not new. As early as 1969, stents were being investigated in the peripheral arterial system as a means of preventing restenosis after dilatation by balloon angioplasty (Dotter, 1969). Since then, numerous reports have demonstrated the use of stents in both the peripheral and coronary artery systems (Maass et al., 1982; Dotter et al., 1983; Wright et al., 1985; Palmaz et al., 1987). Concomitant with the investigation of expandable endovascular metal prosthesis has been the development of prosthetic devices for management of tracheobronchial, gastrointestinal, and genitourinary diseases. We will review the use of endoscopically placed prosthetic devices in the management of diseases affecting these systems. PMID:18493334

  15. [Migration of a stent implanted in the pulmonary artery of a patient with tetralogy of Fallot].

    PubMed

    Palomero Rodríguez, M A; Gabaldón Rivilla, M; Cabestrero Alonso, D; Gonzalez Cibrián, C; Abelleira Pardeiro, C; Centella Hernánez, T; Collado Gutierrez, R; Asuero de Lis, M S; Gómez González, R

    2014-05-01

    Tetralogy of Fallot is a congenital heart disease that accounts for 11-13% of the congenital cardiomyopathies. Stenosis and hyperplasia of the pulmonary arteries occur in a high proportion of them as this disease causes a native stenosis of the pulmonary branch, which can be surgically repaired with a stent. The use of balloon expandable intravascular stents is an alternative technique to further surgery in patients with congenital heart diseases. However, despite the gradual increase in their use, the limited number of procedures, combined with the wide anatomical variability and different characteristics of these patients, even in expert hands, stent implants are associ