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（改编自申请人的摘要）：将开发一种可拆卸的下腔静脉过滤器，以防止暂时面临发生这种危及生命的并发症的风险的患者发生肺栓塞。特殊的设计避免了永久性过滤器的长期不利影响，特别是腔隙闭塞。它克服了其他临时过滤器的局限性，在存在滞留凝块的情况下，这些临时过滤器要么必须永久植入，要么冒着引发肺栓塞的风险而被移除。在美国，每年有多达 100 万患者可能是此类设备的候选者。这项研究的目的是改进原型系统的设计，以实现最佳功效和安全性。将使用标准化凝块制剂和人肺凝块在体外生理模拟中测试捕获效率和可回收性。捕获效率、可回收性、迁移和内皮向内生长将在急性和慢性绵羊模型中进行测试，装置停留时间长达四个星期。完成后，申请人将证明临时腔室过滤系统的可行性，该系统可以捕获凝块并允许去除凝块。该项目将提供一个完善且特征明确的系统，其功效已知，作为未来临床评估和商业化的基础。拟议的商业应用：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。可拆卸过滤器的目的是让有暂时性肺栓塞风险的患者受益。最大的目标群体是接受重大下肢骨科手术的患者。 1994年，在非联邦短期住院医院，474,000名患者接受了下肢关节置换术，89,000名患者接受了其他下肢修复术；此外，还有 27,000 名患有妊娠期和产褥期并发症的患者符合资格。考虑到多发伤和腹部手术患者发生血栓栓塞的风险较高，目标患者总数每年远远超过60万。这些患者都有发生深静脉血栓和随后肺栓塞的风险。其他目标患者是那些已经在医院发现深静脉血栓的患者，估计每年有 500,000 名患者。即使这 110 万患者中只有 1/10 被转诊安装临时过滤器，每年也将需要超过 110,000 个过滤器。永久性过滤器的成本在 600 美元至 1400 美元之间。仅在美国，高效实用的可拆卸过滤系统就可以代表每年 60-1.4 亿美元的市场机会。