INFERIOR VENA CAVA FILTRATION WITH A REMOVABLE DEVICE

描述(摘自申请者的摘要)：将开发一种可拆卸的下腔静脉过滤器，以防止那些暂时有可能发生这种危及生命的并发症的患者发生肺栓塞。具体的设计避免了永久性过滤器的长期不利影响，特别是洞穴堵塞。它克服了其他临时过滤器的局限性，在存在被困凝块的情况下，这些过滤器要么必须永久植入，要么必须移除，有可能导致它们旨在防止的肺血栓。在美国，每年可能有多达100万名患者可能是这种设备的候选者。这项研究的目标是改进原型系统的设计，以达到最佳的疗效和安全性。捕捉效率和可取回性将在使用标准化血栓制剂和人体肺血栓的体外生理学模拟中进行测试。捕捉效率、可回收性、迁移性和内皮生长将在设备停留时间长达四周的急慢性绵羊模型中进行测试。完成后，申请者将证明一种临时腔静脉滤器系统的可行性，该系统可以捕获凝块并允许清除凝块。该项目将为未来的临床评估和商业化提供一个完善的、具有良好特性的系统，并为已知的疗效奠定基础。建议的商业应用：肺血栓栓塞症的风险因素包括制动、整形外科或腹部手术、脊髓损伤、多发伤、心脏病和肿瘤。可拆卸过滤器是为了让有暂时性肺血栓风险的患者受益。最大的目标群体是接受大型下肢矫形手术的患者。1994年，在非联邦短期医院，474 000名患者接受了下肢关节置换术，89 000名患者接受了其他修复；此外，27000名在怀孕和产褥期出现并发症的患者也符合条件。考虑到多发创伤患者和腹部手术患者血栓栓塞症的风险更高，目标患者总数远远超过每年60万人。这些患者都有发生深静脉血栓形成和随后的肺血栓形成的风险。其他目标患者是那些已经在医院知道深静脉血栓形成的患者，估计每年有50万人。即使这110万名患者中只有十分之一被转介放置临时过滤器，每年也需要超过11万个过滤器。永久性过滤器的成本从600美元到1400美元不等。一个高效实用的可拆卸过滤系统仅在美国就代表着每年6000-1.4亿美元的市场机会。

DESCRIPTION (adapted from applicant's abstract): A removable inferior vena cava filter will be developed to prevent pulmonary embolism in patients who are temporarily at risk to develop this life-threatening complication. The specific design avoids long-term adverse effects of permanent filters, especially cavel occlusion. It overcomes limitations of other temporary filters which, in presence of trapped clot, either must be implanted permanently or be removed at risk of precipitating the pulmonary embolism they were intended to prevent. Up to 1 million patients per year in the United States may be candidates for such a device. The objective of this research is to refine the design of a prototype system towards optimal efficacy and safety. Trapping efficiency and retrievability will be tested in a physiologic in vitro simulation using standardized clot preparations and human pulmonary clot. Trapping efficiency, retrievability, migration, and endothelial ingrowth will be tested in an acute and chronic sheep model with device dwell times up to four weeks. On completion the applicant will have demonstrated feasibility of a temporary caval filter system that catches clot and permits clot removal. The project will provide a refined and well-characterized system with known efficacy as basis for future clinical evaluation and commercialization. PROPOSED COMMERCIAL APPLICATION: Risk factors for pulmonary thromboembolism include immobilization, orthopedic or abdominal surgery, spinal cord injury, multiple trauma, cardiac disease and neoplasm. the removable filter is to benefit patients with temporary risk of pulmonary embolisms. The largest target group is patients with major lower extremity orthopedic surgery. In 1994, in non-Federal short-stay hospitals, 474,000 patients underwent joint replacement of the lower extremities and 89,000 underwent other repair of lower extremities; in addition 27,000 patients with complications in pregnancy and puerperium would qualify. considering that patients with multiple trauma and those with abdominal surgeries are at higher risk of thromboembolism, the total pool of target patients far exceeds 600,000 per year. These are all patients who are at risk of developing deep venous thrombosis and subsequent pulmonary embolism. Additional target patients are those who already have known deep venous thrombosis in the hospital, an estimated 500,000 annually. Even if only 1/10 of these 1.1 million patients would be referred for placement of the temporary filter, an annual need of more than 110,000 filters would result. Costs of permanent filters range between $600-$1400. An efficient and practical removable filter system could represent an annual market opportunity of 60- 140 million dollars in the United States alone.