A Self-Monitoring Artificial Vascular Graft

描述（由申请人提供）：在美国，每年有数十万人因为血液循环衰竭而需要在腿部植入人工血管。其中6万名患者需要人工义肢移植。不幸的是，许多人工移植物在短短几年内就被堵塞了（几乎40%的人在一年内失败），导致腿部截肢。这个项目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项目的早期阶段，成功开发并测试了一种“智能移植物”；智能移植物不仅可以输送血液，还可以测量血液流量，并通过植入的收发器将这些测量数据无线传输到体外的基站。如果智能移植物的测量结果显示移植物即将闭塞，基站就会提醒医生移植物即将闭塞。这项更新提案的目的是将智能移植物的发展带到人体试验的准备阶段，这是商业化之前的最后一步，为此，智能移植物将通过在流量测量中增加压力测量来增强，提高其测量的有效性。（它还可以将电池寿命延长一倍）。这种经过改进的智能移植物将被植入狗体内，同时植入一种已经为该项目开发的可控狭窄。当狭窄增加导致移植物闭塞时，通过监测移植物内的流量和压力，可以确定表明移植物即将衰竭的流量和压力变化。这些即将发生的移植物失败的迹象将在项目的最后部分得到验证，其中将对狗一条腿上的智能移植物的寿命与另一条腿上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著延长移植物的使用寿命，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。智能移植物将导致更少的截肢，既改善了护理，也降低了成本。

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.