ULTRAMINIATURE TELEMETRY IMPLANT FOR MEDICAL MONITORING

尽管对植入式遥测的兴趣在这十年中有了很大的增长，但一个主要的技术挑战仍然存在：在微型化植入体的同时增加遥测链路的工作范围。在这一“快速通道”项目下，我们建议建立可行性(第一阶段)，然后开发一种用于监测血压、心率和温度的超微型植入式遥测设备的原型(第二阶段)。最初的重点将是早产和手术后对胎儿的监测。在早产评估和胎儿生命体征监测方面的进展将减少每年影响数千人和花费数十亿美元的重大新生儿和长期健康问题。数据科学公司将与早产管理和胎儿外科领域的先驱斯科特·阿德齐克博士合作，解决以下关键挑战：1)扩大与植入设备的双向通信范围，2)缩小电子设备和电池的尺寸。该设备将利用数据科学国际公司(DSI)已商业化的核心专利技术和诀窍，用于远程血压监测。成功的第一阶段可行性演示将导致加速第二阶段，专注于体内测试的原型制造。拟议的商业应用：如预期的那样，这种新型的超小型监测设备在临床医学中有许多潜在的应用，包括胎儿(手术后)和产科监测，长期动态心血管评估，以及监测危及生命的高血压。实现的进步也将适用于为小动物研究的长期遥测而设计的DSI产品。DSI在将SBIR技术商业化方面有着良好的业绩记录，是SBIR Tibbetts奖的获得者。

Although interest in implantable telemetry has grown substantially during this decade, a major technical challenge remains: increasing the operating range of the telemetry link while miniaturizing the implant body. Under this "Fast-Track" project, we propose to establish feasibility (Phase I) and then develop a prototype (Phase II) of an ultraminiature implantable telemetry device for monitoring pressure, heart rate, and temperature. The initial focus will be on preterm labor and post- surgical monitoring of the fetus following fetal surgery. Advances in preterm labor assessment and monitoring of fetal vital signs will reduce the significant neonatal and long-term health problems that affect thousands and cost billions annually. In collaboration with Dr. Scott Adzick, a pioneer in preterm labor management and fetal surgery, Data Sciences will address the key challenges of 1) increasing the range for bidirectional communications with the implanted device, and 2) size reduction of the electronics and battery. The device will leverage core patented technology and know-how that Data Sciences Int'l (DSI) has commercialized for telemetric monitoring of blood pressure. A successful Phase I feasibility demonstration will lead to an accelerated Phase II focused on prototype fabrication for in vivo testing. PROPOSED COMMERCIAL APPLICATIONS: As envisioned, this novel ultraminiature monitoring device has a number of potential applications in clinical medicine, including fetal (post-surgical) and obstetric monitoring, long-term ambulatory cardiovascular assessment, and monitoring of life- threatening hypertension. Advances realized will also be applicable to DSI products designed for long-term telemetry for small-animal studies. DSI has a proven track record of commercializing SBIR technologies and is an SBIR Tibbetts Award Winner.