Novel Biological Tissue Lined Vascular Stent Crimping and Delivery System

描述（由申请人提供）：心血管疾病是美国死亡的主要原因，动脉粥样硬化是其主要原因。仅根据人口老龄化的统计数据，保守预测2020年将进行约19万例外周血管手术。这种疾病对生活质量和生存有显著的不良影响，5年死亡率高达30%，10年死亡率高达50%。外周动脉疾病（PAD）的一个主要组成部分是动脉粥样硬化导致血液流向下肢的阻塞。在下肢动脉中，股浅动脉（SFA）是最常受PAD影响的，超过50%的PAD涉及SFA。尽管人们热衷于药物涂层支架和动脉粥样硬化切除术装置，但目前还没有理想的血管内解决方案来治疗下肢闭塞性疾病，因为它们尚未被证明对SFA有效，在某些情况下比裸金属支架效果更差。Peritec生物科学公司开发了一种新型腹膜内衬支架（PLS）和独特的输送系统。PLS在动物和早期人体临床研究中表现出优异的性能。PLS附着在自膨胀支架上，该支架必须卷曲并在手术时附着在导管上，以便在SFA中部署。这种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。现有的PLS和输送系统可以熟练地为临床应用提供支架。但是这个过程非常耗时，取决于操作者，需要4到6分钟，并且需要改进以获得临床接受和商业成功。我们对PLS有一些独特和创新的卷曲系统概念，允许在临床环境中将其安装在导管上的安全，简单和快速的过程。在第一阶段，将开发、构建组织衬里支架卷曲概念的3d模型，并使用实验室模型评估关键性能参数。基于第一阶段确定的潜在卷曲技术的筛选，在第二阶段，将确定最佳系统。将构建原型，支架将与新系统进行压接，并将在体外和体内进行评估，以证明新的压接系统不会损害PLS的物理或生物完整性。我们将成功设计一种新的压接方法，用于目前的PLS输送系统，这将减少手术室的准备时间，独立于操作员的技能。并且需要一半的时间来完成支架部署之前的步骤。这将允许使用独特的生物相容性PLS来满足下肢血管粥样硬化治疗中严重且不断增长的未满足需求。公共卫生相关性：随着与衰老、肥胖和糖尿病相关的动脉粥样硬化的快速增加，对由血液阻塞引起的下肢动脉疾病的治疗存在严重的未满足需求。这种疾病对生活质量和生存有显著的不良影响，5年死亡率高达30%，10年死亡率高达50%。股浅动脉（SFA）是腿部最常受影响的动脉。目前还没有理想的血管内治疗下肢闭塞性疾病的方法。独特的腹膜衬里支架可以提供有效的治疗，以满足这一严重和日益增长的下肢血管粥样硬化的治疗需求。

DESCRIPTION (provided by applicant): Cardiovascular disease is the leading cause of death in the United States and atherosclerosis is its major cause. Based on statistics for aging population alone, a conservative prediction is there will be approximately 190,000 peripheral vascular procedures performed in 2020. This disease has significant adverse effects on the quality of life and survival, with mortality as high as 30% in 5 years and 50% in 10 years. A major component of peripheral arterial disease (PAD) is obstruction of blood flow to the lower extremities from atherosclerosis. Of the arteries in the lower extremity, the superficial femoral artery (SFA) is the most commonly affected by PAD with over 50% of all PAD involving the SFA. Despite enthusiasm for drug-coated stents and atherectomy devices, there is no ideal endovascular solution to treating lower extremity occlusive disease, as they have not yet proven to be efficacious in the SFA and in some cases have performed worse than bare metal stents. Peritec Biosciences has developed a novel peritoneum lined stent (PLS) and unique delivery system. The PLS has shown excellent performance in animal and early human clinical studies. The PLS is attached to a self expandable stent which must be crimped and attached to the catheter at the time of surgery for deployment in the SFA. The unique tissue lined stent requires special handling in a novel delivery system developed by the company to maintain its physical and biological integrity. The existing PLS and delivery system is proficient in providing the stent for clinical application. But the process is time consuming, operator dependent, requires 4 to 6 minutes, and needs to be improved for clinical acceptance and commercial success. We have some unique and innovative crimping system concepts for the PLS that permits a safe, simple, and fast process for mounting it on a catheter in the clinical setting. In Phase I, 3-D models of stent crimping concepts for a tissue lined stent will be developed, constructed, and evaluated for key performance parameters using laboratory models. Based on the screening of potential crimping techniques defined in Phase I, in Phase II, the best system(s) will be identified. Prototypes will be constructed and stents will be crimped with the new system which will be evaluated in vitro and in vivo to demonstrate that the new crimping system has not compromised the physical or biological integrity of the PLS. We will successfully design a new crimping method for the current PLS delivery system that will decrease the preparation time in the surgical suite, be independent of operator skill, and require one half the current time to complete the steps prior to stent deployment. This will allow the use of the unique biocompatible PLS to meet a serious and growing unmet need in the treatment of vascular atherosclerosis in the lower extremities. PUBLIC HEALTH RELEVANCE: With the rapid increase in the atherosclerosis associated with aging, obesity, and diabetes, there is a serious unmet need for treatment of lower extremities artery disease resulting from obstruction of blood. This disease has significant adverse effects on the quality of life and survival, with mortality as high as 30% in 5 years and 50% in 10 years. The superficial femoral artery (SFA) is the most commonly affected artery in the leg. There is currently no ideal endovascular solution to treating lower extremity occlusive disease. The unique peritoneum lined stent can provide effective treatment to meet this serious and growing need in the treatment of vascular atherosclerosis in the lower extremities.