A Self-Monitoring Artificial Vascular Graft

自我监测人工血管移植物

• 批准号: 8249422
• 负责人: John Blebea
• 金额: $ 44.85万
• 依托单位: DVX, LLC
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-01 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8249422
• 关键词: Adverse effects; Amputation; Animal Model; Arrhythmia; Arteries; Atrial Fibrillation; Blood; Blood Circulation; Blood Substitutes; Blood Vessels; Blood flow; Businesses; Bypass; Canis familiaris; Caring; Characteristics; Clinical; Clinical Trials; Coagulation Process; Data; Dependence; Development; Devices; Doppler Ultrasound; Electronics; Failure; Frequencies; Funding; Goals; Grant; Heart; Heart Rate; Human; Husband; Implant; Intervention; Lead; Learning; Leg; Life; Measurement; Measures; Medical; Monitor; Pacemakers; Patients; Phase; Physicians; Preparation; Prosthesis; Quality of life; Readiness; Research; Safety; Sheep; Side; Signal Transduction; Sinus; Sleep; Small Business Innovation Research Grant; Spinal Cord; Staging; Stenosis; System; Techniques; Testing; Time; Vascular Graft; Work; base; biomaterial compatibility; commercialization; control trial; cost; design; electric impedance; graft failure; improved; meetings; pressure; prevent; programs; public health relevance; sensor

DESCRIPTION (provided by applicant): Several hundred thousand people in the USA each year require artificial blood vessels, "grafts", to be placed in their legs because of failing circulation. Sixty thousand of these patients require artificial prosthetic grafts. Unfortunately, many of the artificial grafts become occluded in just a few years (almost 40 % fail within a year), leading to leg amputation. The overall goal of this program is to improve the lives of people requiring artificial vascular grafts by decreasing the need for amputation. In addition to improving quality of life, there will be a substantial reduction in cost to the medical system. In earlier phases of this SBIR program, a "smart graft" was successfully developed and tested; a smart graft not only carries blood, but also measures the blood flow and, by means of an implanted transceiver, wirelessly transmits these measurements to a base station outside the body. The base station alerts a physician to an impending graft occlusion if the smart graft's measurements show impending occlusion. The purpose of this Renewal proposal is to bring the development of the smart graft to the point of readiness for human trials, the last step before commercialization To do so, the smart graft will be enhanced by adding pressure measuring to flow measuring, improving the validity of its measurements. (It also allows doubling the battery-life). The improved smart grafts will be implanted in dogs along with a controllable stenosis, already developed for this program. By monitoring the flow and pressure in the graft as the stenosis is increased causing the graft to occlude, the changes in flow and pressure that show impending graft failure can be determined. These signs of imminent graft failure will be validated in the final part of the program in which smart graft life in one leg of a dog will be compared with the survival of a conventional graft in the other leg. The trial is designed to show that smart grafts will significantly increase graft life and therefore reduce amputations. In addition, the trial will demonstrate the safety of the smart graft, i.e. its biocompatibility and lack of side effects. With proof of graft efficacy and safety, human trials of smart grafts will be able to begin. Smart grafts will lead to far fewer amputations, both improving care and also reducing costs. PUBLIC HEALTH RELEVANCE: The artificial grafts needed to correct poor circulation in the legs frequently become occluded, which leads to amputation of the legs. We have developed a new graft that alerts the physician that the graft is occluding to allow timely intervention, and thus prevents graft failure. Reducing the number of amputations both improves quality of life and reduces costs.

描述（由申请人提供）：每年在美国数十万人需要人造血管“移植物”，因为循环失败，将其放在腿上。这些患者中有六万需要人工假肢移植物。不幸的是，许多人造移植物在短短几年内被阻塞（一年内失败了40％），从而导致截肢。该计划的总体目标是通过减少截肢的需求来改善需要人造血管移植的人的生活。除了改善生活质量外，医疗系统的成本还大大降低。在该SBIR计划的较早阶段中，成功开发和测试了“智能移植”。智能移植物不仅携带血液，还可以测量血液流动，并通过植入的收载体将这些测量值无线传输到体内的基站。如果Smart Graft的测量值显示出闭塞，则基站会提醒医生即将进行的移植物闭塞。该更新建议的目的是使智能移植物的发展达到人类试验的准备点，这是商业化之前的最后一步，通过为流量测量增加压力测量，提高其测量的有效性，可以增强智能移植物。 （它还允许将电池寿命加倍）。改进的智能移植物将植入狗，以及已经为该程序开发的可控狭窄。通过监测移植物中的流量和压力，随着狭窄的增加而导致移植物的闭塞，可以确定表现出即将发生的移植物失败的流量和压力的变化。这些迫在眉睫的移植失败的迹象将在该程序的最后部分得到验证，在该程序的最后部分，将一条狗的智能移植生命与另一只腿中传统的移植物的生存进行比较。该试验旨在表明智能移植物将大大提高移植物的寿命，从而减少截肢。此外，该试验将证明智能移植物的安全性，即其生物相容性和缺乏副作用。有了移植功效和安全性的证明，智能移植物的人体试验将能够开始。智能移植物将导致截肢少得多，既可以改善护理和降低成本。 公共卫生相关性：纠正腿部循环不良所需的人造移植物经常被阻塞，从而导致腿部截肢。我们已经开发了一种新的移植物，该移植物提醒医生，移植物正在阻塞以及时干预，从而防止了移植失败。减少截肢次数可以提高生活质量并降低成本。