A Self-Monitoring Artificial Vascular Graft

描述（由申请人提供）：在美国，每年有几十万人需要人造血管，“移植物”，因为循环衰竭而被放置在他们的腿上。这些患者中有6万人需要人工假体移植。不幸的是，许多人工移植物在短短几年内就会闭塞（几乎40%在一年内失败），导致腿部截肢。该计划的总体目标是通过减少截肢的需要来改善需要人工血管移植的人的生活。除了提高生活质量外，医疗系统的成本也将大幅降低。在SBIR计划的早期阶段，成功开发和测试了“智能移植物”;智能移植物不仅携带血液，而且还测量血流，并通过植入的收发器将这些测量结果无线传输到体外的基站。如果智能移植物的测量结果显示即将发生阻塞，则基站向医生发出即将发生移植物阻塞的警报。该更新提案的目的是使智能移植物的开发达到人体试验的准备程度，这是商业化之前的最后一步。为此，将通过在流量测量中增加压力测量来增强智能移植物，提高其测量的有效性。(It也允许电池寿命加倍）。改进的智能移植物将植入狗沿着与一个可控的狭窄，已经开发了这个计划。当狭窄增加导致移植物闭塞时，通过监测移植物中的流量和压力，可以确定显示即将发生的移植物失效的流量和压力的变化。这些即将发生移植物失效的迹象将在项目的最后部分进行验证，其中将犬一条腿中的智能移植物寿命与另一条腿中的传统移植物的存活率进行比较。该试验旨在表明智能移植物将显着增加移植物的寿命，从而减少截肢。此外，该试验将证明smart移植物的安全性，即其生物相容性和无副作用。随着移植物有效性和安全性的证明，智能移植物的人体试验将能够开始。智能移植将大大减少截肢，既改善护理，也降低成本。 公共卫生相关性：用于纠正腿部血液循环不良的人工移植物经常堵塞，导致腿部截肢。我们开发了一种新的移植物，可以提醒医生移植物堵塞，以便及时干预，从而防止移植物失效。减少截肢数量既能提高生活质量，又能降低成本。

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.