Novel Biological Tissue Lined Vascular Stent Crimping and Delivery System

简介(申请人提供)：心血管疾病是美国主要的死亡原因，动脉粥样硬化是其主要原因。仅根据老龄化人口的统计数据，一项保守的预测是，2020年将进行大约19万例周围血管手术。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的下肢血流受阻。在下肢动脉中，股浅动脉(SFA)是最常见的PAD，超过50%的PAD累及SFA。尽管药物涂层支架和动脉粥样硬化装置备受欢迎，但目前还没有理想的血管内解决方案来治疗下肢闭塞症，因为它们在SFA中还没有被证明有效，在某些情况下比裸金属支架的表现更差。PeriTec生物科学公司开发了一种新型腹膜衬里支架(PLS)和独特的输送系统。在动物和早期人类的临床研究中，偏最小二乘法表现出了优异的性能。在手术时，必须将支架卷曲并连接到导管上，以便在SFA中进行部署。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。现有的偏最小二乘法和输送系统在为临床应用提供支架方面是熟练的。但这一过程耗时长，依赖于操作员，需要4到6分钟，需要改进才能获得临床认可和商业成功。我们有一些独特和创新的卷曲系统概念，可以在临床环境中安全、简单和快速地将其安装在导管上。在第一阶段，将开发、建造组织衬里支架的支架卷曲概念的3D模型，并使用实验室模型评估关键性能参数。在筛选第一阶段定义的潜在卷曲技术的基础上，在第二阶段，将确定最佳系统(S)。将构建原型，并使用新系统卷曲支架，新系统将在体外和体内进行评估，以证明新的卷曲系统并未损害PLS的物理或生物完整性。我们将成功地设计一种新的卷曲方法，用于目前的PLS机输送系统，它将减少手术套间的准备时间，不依赖于操作员的技能，并且在支架部署之前需要目前一半的时间来完成步骤。这将使独特的生物相容的最低限度的使用，以满足严重的和日益增长的需求未得到满足的血管动脉粥样硬化的治疗在下肢。

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.