Commercialization of Tissue Lined Stent Graft for Dialysis Access Failure

描述(由申请人提供)：估计11.5%的成年人(约2300万人)患有慢性肾脏疾病。在患有终末期呼吸窘迫综合征的人中，死亡率约为每千人年中有163.8人死亡。血液透析是美国超过341,000名患有终末期肾病(ESRD)或肾衰竭的患者的主要治疗方法，肾衰竭可由糖尿病和高血压等常见慢性疾病引起。由于并不是所有的患者都能等上一段时间直到瘘管成熟，或者它不能用于静脉脆弱的人，因此，房室静脉移植物的市场正在增加。因此，美国终末期肾病患者S的人数持续上升，移植血管的使用将继续被用作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，移植需求也可能保持强劲。目前移植物的问题是它们有很高的凝血和再狭窄的可能性，导致感染的可能性很高。他们经常在静脉吻合口出现狭窄，失败率很高。尽管人们对聚四氟乙烯和其他生物移植物充满热情，但目前还没有理想的解决方案来治疗终末期肾病，因为它们作为一种血管通路尚未被证明是有效的。此外，自然动脉静脉瘘也是一种很高的失败 Rate PeriTec生物科学公司开发了一种新型腹膜衬里支架(PLS)。在动物和国际人类临床研究中，对于透析通路失败和股动脉闭塞疾病，该系统都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一种治疗方法，以改善透析通道狭窄。这些独特的组织衬里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已经开发出一种更高效、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扩张端。这一发展将在未来3年内进行。第一阶段正在进行中，我们正在寻求资金以加快发展。计算机辅助设计(CAD)模型将被测试各种非临床因素，如流体流动分析、风险分析和支架的材料特性。所有测试将在ASTM标准下进行，并将满足适当的FDA要求。第二阶段，包括对组织支架进行力学测试，以达到更高的功能程度。将进行加速疲劳试验，目的是确定应力范围与失效前可应用的次数之间的关系。这些特定的测试是脉动测试和轴向/扭转测试。最后，将进行活体动物测试，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，可满足终末期肾脏疾病治疗中严重且日益增长的未得到满足的需求。

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.