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INFERIOR VENA CAVA FILTRATION WITH A REMOVABLE DEVICE

使用可拆卸装置进行下腔静脉过滤

基本信息

批准号：
2716934
负责人：
ELVIRA Valentina LANG-ANDERSON
金额：
$ 9.95万
依托单位：
CIVCO MEDICAL INSTRUMENTS COMPANY, INC.
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
起止时间：
1999-05-21 至 2000-05-20
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/2716934
关键词：
biomaterial development /preparation biomedical equipment development blood filtration circulatory assist clinical biomedical equipment consumable /disposable biomedical equipment disease /disorder prevention /control pulmonary circulation obstruction sheep veins

项目摘要

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.

描述（改编自申请人摘要）：将开发一种可拆卸下腔静脉滤器，以预防暂时有发生这种危及生命的并发症风险的患者发生肺栓塞。该特定设计避免了永久性滤器的长期不良影响，尤其是腔静脉闭塞。它克服了其他临时过滤器的局限性，在存在捕获的凝块的情况下，必须永久植入或在有诱发肺栓塞风险的情况下移除。在美国，每年多达100万患者可能是这种设备的候选人。本研究的目的是完善原型系统的设计，以达到最佳的疗效和安全性。将使用标准凝块制备物和人肺凝块在体外生理模拟中测试捕获效率和可回收性。将在急性和慢性绵羊模型中测试捕获效率、可回收性、迁移和内皮长入，器械停留时间长达4周。完成后，申请人将证明临时腔静脉滤器系统的可行性，该系统可捕获凝块并允许凝块清除。该项目将提供一个具有已知疗效的精制和良好表征的系统，作为未来临床评价和商业化的基础。拟定商业应用：肺血栓栓塞的危险因素包括制动、骨科或腹部手术、脊髓损伤、多发性创伤、心脏病和肿瘤。可移除过滤器有益于具有暂时性肺栓塞风险的患者。最大的目标人群是下肢骨科大手术患者。1994年，在非联邦短期住院医院中，474，000名病人接受了下肢关节置换术，89，000名病人接受了下肢其他修复术;此外，27，000名患有妊娠和产后并发症的病人也符合条件。考虑到多重创伤和腹部手术的病人患血栓栓塞的风险较高，每年的目标病人总数远远超过60万人。这些患者都有发生深静脉血栓形成和随后的肺栓塞的风险。其他目标患者是那些在医院已经知道深静脉血栓形成的患者，估计每年有50万人。即使这1/10万患者中只有1/10的患者被转诊放置临时滤器，每年也需要超过1/10，000个滤器。永久过滤器的成本在600美元至1400美元之间。一个有效和实用的可拆卸过滤器系统仅在美国就代表着每年6000万至1.4亿美元的市场机会。