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: 8730632
• 负责人: Don Gustavson
• 金额: $ 41.73万
• 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 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8730632
• 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; 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; screening

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.

描述（由申请人提供）：估计有 11.5% 的成年人（约 2300 万人）患有慢性肾病。在患有终末期肾病 (ESRD) 的患者中，死亡率约为每 1,000 名患者年 163.8 人死亡。血液透析是美国超过 341,000 名终末期肾病 (ESRD) 或肾衰竭患者的主要治疗方法，肾衰竭可能由糖尿病和高血压等常见慢性病引起。 AV 移植物的市场正在不断增长，因为并非所有患者都可以等待瘘管成熟，或者它不能用于静脉脆弱的人。因此，随着美国患有终末期肾病 (ESRD) 的人数持续增加，移植物将继续作为血管通路的一种手段。随着血液透析患者中​​糖尿病患者数量的增加，移植物需求也可能保持强劲。目前移植物的问题是它们很容易发生凝血和再狭窄，并且很容易引起感染。他们经常在静脉吻合处出现狭窄，并且失败率很高。尽管人们对 PTFE 和其他生物移植物充满热情，但目前还没有治疗 ESRD 的理想解决方案，因为它们尚未被证明作为血管通路有效。此外，自体动静脉瘘的失败率也很高 PeriTec Biosciences 开发了一种新型腹膜内衬支架 (PLS)。 PLS 在针对透析通路失败和股动脉闭塞性疾病的动物和国际人体临床研究中表现出了优异的性能。 Peritec 现在的目标是开发支架移植物作为改善透析通路狭窄的治疗方法。这些独特的组织内衬支架需要在该公司开发的新型输送系统中进行特殊处理，以保持其物理和生物完整性。 Peritec 开发了一种更高效、更安全的支架，专门为容纳组织而设计；所需的特性包括不同的径向力和扩口端。这一发展将在未来三年内发生。第一阶段正在进行中，我们寻求资金来加速开发。计算机辅助设计 (CAD) 模型将针对各种非临床因素进行测试，例如流体流动分析、风险分析和支架材料表征。所有测试都将根据 ASTM 标准进行，并满足 FDA 的相应要求。第二阶段包括对组织支架进行更高程度功能的机械测试。进行加速疲劳测试的目的是确定应力范围与失效前可施加的次数之间的关系。这些特定测试是脉冲测试和轴向/扭转测试。最后，将进行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 Peritec 支架可满足治疗终末期肾病方面日益增长的未满足的严重需求。