Commercialization of Tissue Lined Stent Graft for Dialysis Access Failure

用于透析通路失败的组织衬里覆膜支架的商业化

• 批准号: 8314421
• 负责人: Don Gustavson
• 金额: $ 19.2万
• 依托单位: PERITEC BIOSCIENCES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-25 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8314421
• 关键词: Acute; Adult; Aging; American; Anastomosis - action; Animal Model; Animal Testing; Animals; Area; Biocompatible Materials; Biological; Blood; Blood Vessels; Blood flow; Cessation of life; Characteristics; Chronic; Chronic Kidney Failure; Clinical Research; Coagulation Process; Computer Assisted; Computer-Aided Design; Corrosion; Data Analyses; Development; Devices; Diabetes Mellitus; Dialysis procedure; Disease; Elasticity; End stage renal failure; Ensure; Equipment Malfunction; Experimental Designs; Failure; Fatigue; Finite Element Analysis; Fistula; Flare; Funding; Future; Goals; Healed; Hemodialysis; Histology; Human; Hypertension; Infection; Inflammatory Response; International; Kidney Failure; Length; Marketing; Materials Testing; Measures; Mechanics; Memory; Methodology; Methods; Metric; Modeling; Patients; Performance; Peripheral; Peritoneum; Phase; Polytetrafluoroethylene; Procedures; Process; Property; Prosthesis; Protocols documentation; Radial; Recurrence; Reporting; Risk; Screening procedure; Shapes; Solutions; Staging; Stenosis; Stents; Stress; Surface; System; Tensile Strength; Testing; Time; Tissue Model; Tissues; Torsion; Toxic effect; United States; Veins; Venous; Visual; Writing; commercialization; cost; design; design and construction; diabetic; femoral artery; fluid flow; hazard; healing; improved; in vivo; meetings; minimally invasive; mortality; nitinol; novel; patient population; prototype; response; restenosis; scaffold

DESCRIPTION (provided by applicant): An estimated 11.5 percent of adults (approx 23 million people) suffer from chronic kidney disease. Among people suffering from ESRD, the mortality is approximately 163.8 deaths per 1,000 patient years. Hemodialysis is the leading treatment for more than 341,000 patients in the United States with end-stage renal disease (ESRD), or kidney failure, which can be caused by common chronic conditions such as diabetes and hypertension. The market for AV grafts is increasing since not all patients can wait the length of time for the fistula to mature or it cannot be used for people with fragile veins. Thus, s the number of Americans with end-stage renal disease (ESRD) continues to rise, the use of grafts will continue to be employed as a means of vascular access. As the number of diabetics within the hemodialysis patient population grows, it is also likely that graft demand will remain strong. The problem with the current grafts is their high potential for clotting and restenosis, an high potential for causing an infection. They frequently develop stenoses at the venous anastomosis and have a high rate of failure. Despite enthusiasm for PTFE and other biological grafts, there is no ideal solution to treating ESRD, as they have not been proven to be efficacious as a vascular access. Additionally, native arterial venous fistulas also a high failure rate PeriTec Biosciences has developed a novel peritoneum lined stent (PLS). The PLS has shown excellent performance in animal and international human clinical studies for both dialysis access failure and femoral artery occlusive disease. Peritec now aims to develop the stent graft to use as a treatment method to improve dialysis access stenosis. These unique tissue lined stents require special handling in a novel delivery system developed by the company to maintain their physical and biological integrity. Peritec has developed a more efficient and safe stent scaffold specifically designed to accommodate the tissue; the desired characteristics include different radial forces and flared ends. This development will take place over the next 3 years. Phase I is underway and we seek funding to accelerate development. Computer aided design (CAD) models will be tested for various non-clinical factors such as fluid flow analysis, risk analysis, and material characterization of stents. All tests will be performed under ASTM standards and appropriate FDA requirements will be met. Phase II, includes mechanical tests of the tissue stents to a higher degree of function. Accelerated fatigue tests will be done with the objective of determining the relationship between the stress range and number of times it can be applied before failure. These specific tests are Pulsatile and Axial/Torsion Testing. Finally, i vivo animal testing will be performed to validate our stent designs. This will allow the use of the unique tissue lined Peritec stents to meet a serious and growing unmet need in the treatment of End Stage Renal Disease. PUBLIC HEALTH RELEVANCE: With the rapid increase in the people suffering from End Stage Renal Disease associated with aging, hypertension, and diabetes, there is a serious unmet need for creating a suitable vascular access to perform hemodialysis. Unfortunately, while the existing initial procedures are effective in the acute stage, recurrent failure is the nom. The cost of failure is very high. One highly touted minimally invasive procedure designed to improve on these failures is using the combination of a stent and prosthetic (called a stent graft) The mechanical stent props open the blockage, and the prosthetic provides a new surface for the blood to flow through. However, after just a short period of time the prosthetic causes an inflammatory response, which leads to yet another recurrent failure. Additionally, native arterial venous fistulas also have high failure rates, albeit they do perform better than AV grafts. The vein may not mature properly to a size where blood flow is sufficient and the fistula requires months to heal and the vein may become more difficult to cannulate compared to a graft. Our goal is to improve the patency in the patients intervened on with failing arteriovenous grafts and fistulas. We believe that intervening with a stent graft with a biological material attached to it an improve patency. Peritec has developed a biologically tissue lined stent which will improve on current results.

描述（由申请人提供）：估计有11.5％的成年人（约2300万人）患有慢性肾脏疾病。在患有ESRD的人中，死亡率约为每1000名患者的死亡人数约为163.8例。血液透析是美国有341,000多名患有末期肾脏疾病（ESRD）或肾衰竭的患者的领先治疗方法，这可能是由常见的慢性疾病（例如糖尿病和高血压）引起的。 AV移植物的市场正在增加，因为并非所有患者都可以等待瘘管成熟的时间长度，或者不能用于静脉脆弱的人。因此，终末期肾脏疾病（ESRD）的美国人数量继续增加，将继续使用移植物作为血管通道的一种手段。随着血液透析患者人群中糖尿病患者的数量的增加，移植物需求也可能会保持强劲。当前移植物的问题在于它们的凝血和再狭窄的高潜力，这是引起感染的高潜力。他们经常在静脉吻合术处发展促刺，并且失败率很高。尽管对PTFE和其他生物移植物的热情，但没有理想的解决方案来治疗ESRD，因为尚未被证明是有效的血管通道。此外，天然动脉静脉瘘也是高衰竭 速率Peritec Biosciences已开发出一种新型的腹膜衬里支架（PLS）。 PLS在动物和国际人类临床研究中表现出卓越的表现，可用于透析通道衰竭和股动脉闭塞性疾病。 PETITEC现在旨在开发用于改善透析渗透狭窄的治疗方法的支架移植物。这些独特的组织衬里支架需要在公司开发的新型交付系统中进行特殊处理，以维持其物理和生物的完整性。 Peritec开发了一种更高效，更安全的支架支架，专门为容纳组织而设计。所需的特征包括不同的径向力和喇叭形末端。这一发展将在未来3年内进行。第一阶段正在进行中，我们寻求资金加速发展。计算机辅助设计（CAD）模型将测试各种非临床因素，例如流体流量分析，风险分析和支架的材料表征。所有测试将根据ASTM标准执行，并将满足适当的FDA要求。第二阶段，包括对组织支架的机械测试，具有较高的功能。将进行加速疲劳测试，目的是确定应力范围和可以在失败之前应用的次数之间的关系。这些特定的测试是脉动和轴向/扭转测试。最后，将进行我的体内动物测试以验证我们的支架设计。这将允许使用 独特的组织衬里的peritec支架满足了终阶段肾脏疾病的严重且未满足的需求。 公共卫生相关性：随着与衰老，高血压和糖尿病有关的终阶段肾脏疾病的人的迅速增加，有很大的未满足需要创建合适的血管通道来进行血液透析。不幸的是，尽管现有的初始程序在急性阶段有效，但反复失败是NOM。失败成本很高。一种旨在改善这些故障的高度吹捧的微创程序是使用支架和假肢（称为支架移植物）的组合，机械支架支架打开了阻塞，而假肢为血液提供了新的表面。但是，仅短短一段时间后，假肢就会引起炎症反应，从而导致另一个复发失败。此外，天然动脉静脉瘘也具有很高的衰竭率，尽管它们的性能比AV移植物更好。静脉可能无法正确成熟到血流足够的大小，瘘管需要几个月才能愈合，并且与移植物相比，静脉可能会变得更难以容易插入。我们的目标是提高干预动静脉移植和瘘管失败的患者的通畅性。我们认为，将支架移植物与附着在其上的生物材料相关的介入具有提高的通畅性。 Peritec开发了一个生物组织衬里的支架，该支架将改善当前结果。