ULTRAMINIATURE TELEMETRY IMPLANT FOR MEDICAL MONITORING

虽然对植入式遥测技术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：在使植入体小型化的同时增加遥测链路的操作范围。在这个“快速通道”项目中，我们建议建立可行性（第一阶段），然后开发一个用于监测压力、心率和温度的超小型植入式遥测装置的原型（第二阶段）。最初的重点将放在早产和胎儿手术后胎儿的术后监测。早产评估和胎儿生命体征监测的进展将减少重大的新生儿和长期健康问题，这些问题每年影响数千人，耗资数十亿美元。Data Sciences将与早产管理和胎儿手术领域的先驱Scott Adzick博士合作，解决以下关键挑战：1)增加与植入设备的双向通信范围；2)减小电子设备和电池的尺寸。该设备将利用Data Sciences Int'l （DSI）商业化的血压遥测监测核心专利技术和专有技术。成功的第一阶段可行性论证将导致第二阶段的加速，重点是体内测试的原型制造。拟议的商业应用：正如设想的那样，这种新型的超微型监测设备在临床医学中有许多潜在的应用，包括胎儿（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。实现的进展也将适用于设计用于小动物研究的长期遥测的DSI产品。DSI在SBIR技术商业化方面有着良好的记录，并且是SBIR Tibbetts奖得主。

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.