A Self-Monitoring Artificial Vascular Graft

描述(由申请人提供)： 大多数人工血管移植物，包括去年在美国植入的6万例，在不到三年的时间里就失败了，导致截肢。通过移植物的血流量减少已被证明是RAFT失败的先兆。该计划的长期目标是通过使移植物变得“智能”来延长人工移植物的寿命，即使移植物能够测量其流量，并在流量减少时呼叫医生进行干预。 该计划的第一阶段实现了其具体目标：1)展示使用小到足以完全嵌入血管移植物的多普勒传感器进行准确的流量测量，以及2)设计能够驱动传感器并将流量信息无线传输到床边监护仪的电路，同时消耗足够低的电力，供植入式电池使用5年。 第二阶段是提供数据，以便进行人体临床试验。组件的寿命和可靠性将得到验证，功能性智能移植物将被制造并植入动物体内。动物试验将证明这些装置的安全性、功能性和延长的移植物寿命。

DESCRIPTION (provided by applicant): Most artificial vascular grafts, of which 60,000 were implanted in the USA last year, fail in less than three years, leading to amputation. Diminishing blood flow through the graft has been shown to be a precursor of raft failure. The long-term objective of this program is to extend artificial graft life by making the grafts "smart", i.e. making the graft capable of measuring its flow and calling a physician for intervention if the flow diminishes. Phase I of the program achieved its specific aims of 1) demonstrating accurate flow measurement using a Doppler sensor small enough to be completely embedded in a vascular graft and 2) designing circuitry capable of driving the sensor and wirelessly transmitting the flow information to a bedside monitor while consuming low enough power for 5-years of life from an implantable battery. Phase II is to provide data to enable human clinical trials. Component life and reliability will be validated, and functional smart grafts will be fabricated and implantated in animals. Animal trials will demonstrate the safety, functionality, and extended graft life of these devices.