ULTRAMINIATURE TELEMETRY IMPLANT FOR MEDICAL MONITORING

用于医疗监测的超小型遥测植入物

• 批准号: 2713914
• 负责人: PERRY A MILLS
• 金额: $ 10万
• 依托单位: TRANSOMA MEDICAL
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-02-15 至 2000-02-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2713914
• 关键词: bioengineering /biomedical engineering; biomedical device power system; biomedical equipment development; blood pressure; body temperature; computer program /software; computer system design /evaluation; electrocardiography; heart rate; implant; medical implant science; microprocessor /microchip; miniature biomedical equipment; patient monitoring device; postoperative state; premature labor; telemetry

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.

尽管在这十年中，对植入式遥测的兴趣大幅增长，但仍然存在一个主要的技术挑战：增加遥测链路的操作范围，同时使植入体膨胀。在这个“快速通道”项目下，我们建议建立可行性（第一阶段），然后开发一个用于监测压力，心率和温度的超小型植入式遥测设备的原型（第二阶段）。最初的重点将放在早产和胎儿手术后的胎儿手术后监测。早产评估和胎儿生命体征监测的进展将减少影响数千人并每年花费数十亿美元的重大新生儿和长期健康问题。Data Sciences与早产管理和胎儿手术领域的先驱Scott Adzick博士合作，将解决以下关键挑战：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）已商业化的血压遥测监测核心专利技术和专有技术。一个成功的第一阶段的可行性论证将导致加速第二阶段的重点是原型制造的体内测试。拟议的商业应用：如所设想的，这种新颖的超小型监测装置在临床医学中具有许多潜在应用，包括胎儿（手术后）和产科监测、长期动态心血管评估以及威胁生命的高血压的监测。所实现的进展也将适用于为小动物研究长期遥测而设计的DSI产品。DSI在SBIR技术的商业化方面有着良好的记录，是SBIR Tibbetts奖的赢家。