Novel Biological Tissue Lined Vascular Stent Crimping and Delivery System

新型生物组织内衬血管支架压接和输送系统

• 批准号: 7895635
• 负责人: Michael John Wiggins
• 金额: $ 48.15万
• 依托单位: PERITEC BIOSCIENCES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-15 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7895635
• 关键词: 3-Dimensional; Adhesives; Adverse effects; Affect; Age; Aging; Amputation; Anatomy; Animal Testing; Animals; Arteries; Asses; Atherectomy; Atherosclerosis; Biocompatible; Biological; Blood; Blood Vessels; Blood flow; Caliber; Cardiovascular Diseases; Catheters; Cause of Death; Chemicals; Clinic; Clinical; Clinical Research; Coagulation Process; Custom; Development; Devices; Diabetes Mellitus; Disease; Ensure; Environment; Equipment; Etiology; Europe; Evaluation; Experimental Designs; Failure; Foot Ulcer; Foundations; Fracture; Goals; Government; Guns; Heating; Hour; Human; Human Resources; Humidity; Hyperplasia; In Vitro; Injection of therapeutic agent; Intervention; Iron; Laboratories; Left; Leg; Length; Length of Stay; Lesion; Lower Extremity; Manufacturer Name; Measurement; Mechanics; Medical; Metals; Methodology; Methods; Modeling; Molds; Morbidity - disease rate; National Health and Nutrition Examination Survey; Nature; North America; Obesity; Obstruction; Operative Surgical Procedures; Outcome; Patient Preferences; Performance; Peripheral; Peripheral Nervous System Diseases; Peripheral arterial disease; Peritoneal; Peritoneum; Persons; Pharmaceutical Preparations; Phase; Plastics; Polymers; Population; Preparation; Prevalence; Procedures; Process; Quality of life; Radial; Recording of previous events; Rest; Risk; Sample Size; Sampling; Screening procedure; Slide; Societies; Solutions; Solvents; Source; Stents; Stroke; Superficial Femoral Artery; Surgeon; System; Techniques; Temperature; Testing; Time; Tissues; Toes; Training; United States; Vascular Patency; Work; aged; aging population; base; clinical application; design; disability; economic impact; effective therapy; experience; extreme temperature; flexibility; foot; functional decline; iliac artery; improved; in vitro testing; in vivo; innovation; instrument; meetings; minimally invasive; mortality; novel; performance tests; pressure; prevent; programs; prototype; restenosis; skills; statistics; success; theories; tool

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.

描述（由申请人提供）：心血管疾病是美国的主要死亡原因，动脉粥样硬化是其主要原因。仅根据老龄化人群的统计数据，保守预测2020年将进行约190，000例外周血管手术。这种疾病对生活质量和生存期有显著的不利影响，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阻塞。在下肢动脉中，股浅动脉（SFA）是最常受PAD影响的动脉，超过50%的PAD涉及SFA。尽管药物涂层支架和斑块旋切术器械备受青睐，但治疗下肢闭塞性疾病还没有理想的血管内解决方案，因为尚未证明它们在SFA中有效，并且在某些情况下表现不如裸金属支架。Peritec Biosciences开发了一种新型腹膜内衬支架（PLS）和独特的输送系统。PLS在动物和早期人类临床研究中表现出优异的性能。PLS连接到自膨式支架上，在手术时必须压握并连接到导管上，以便在SFA中展开。独特的组织内衬支架需要在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和输送系统能够为临床应用提供支架。但是该过程耗时，依赖于操作者，需要4至6分钟，并且需要改进以获得临床接受度和商业成功。我们为PLS设计了一些独特的创新压接系统概念，可以在临床环境中安全、简单、快速地将其安装在导管上。在第I阶段，将开发、构建组织内衬支架的支架压握概念的3-D模型，并使用实验室模型评价关键性能参数。根据第I阶段中定义的潜在预置技术筛选，在第II阶段中，将确定最佳系统。将构建原型，并使用新系统预置支架，并进行体外和体内评价，以证明新预置系统不会损害PLS的物理或生物完整性。我们将为当前的PLS输送系统成功设计一种新的预置方法，该方法将减少手术室的准备时间，不依赖于操作者的技能，并且在支架展开之前完成这些步骤所需的时间为当前时间的一半。这将允许使用独特的生物相容性PLS来满足下肢血管动脉粥样硬化治疗中严重且不断增长的未满足需求。