Implantable Sensor for Transplant Tissue Monitoring

描述（由申请人提供）：提出了一种植入式组织监测系统，以解决现有组织灌注监测仪器在各种临床应用中的局限性。植入系统预期作为微创筛查工具，提供实时组织灌注和氧气评估，以提示医生注意并应用已建立的诊断和侵入性纠正程序，特别是用于肝移植。该系统依赖于基于光子学的测量，结合集成的信号处理和数据遥测，以提供组织灌注的实时监测。该方法和实施是针对外科手术和手术后的程序，并已应用到一些额外的监测方案，包括急诊医学和重症监护。微型化将使用微制造技术来实现，从而允许将传感器系统完全植入到精确的感兴趣区域中，作为皮下或深部组织植入物。信号处理将被纳入植入的微系统中，以降低数据通信要求，并可能实现自动化过程控制。三波长系统最初将在许多临床场景中设计和测试，以评估灌注的相对水平，并建立使用该技术的临床方案。将开发动脉和静脉血氧饱和度定量的其他功能，以评估器官氧利用率。将使用生物相容性封装材料，以实现长期监测方案。扩频RF数据通信的使用将确保高完整性的数据遥测，并避免对现有医疗仪器系统的RF干扰。这也将允许部署多个传感器在附近更全面的病人监测应用。该项目的最终目标是生产一种可工作的植入式系统，该系统具有完善的临床应用和通过动物试验证明的相关方案。主要研究者Mark A与医学、生物工程和工程专业人士进行了强有力的合作，并发表了合作史。Wilson，MD，PhD（匹兹堡大学）和首席研究员M。Nance Ericson博士（橡树岭国家实验室）和Gerard L. Cote，PhD（Texas A&M University）. Wilson博士负责总体研究协调和临床应用研究。Ericson博士负责电子产品的开发，Cote博士负责光学传感策略。这种合作提供了必要的专业知识和研究设施，以成功地解决重要的临床病人监测问题，使用医疗光子学和智能医疗仪器在一个独特的集成包的组合。

DESCRIPTION (provided by applicant): An implantable tissue monitoring system is proposed to address the limitations of existing instrumentation for tissue perfusion monitoring for a variety of clinical applications. The implanted system is intended as a minimally-invasive screening tool that provides real-time tissue perfusion and oxygen assessment to prompt physician attention and the application of established diagnostics and invasive corrective procedures, in particular for liver transplant. The system relies on photonics-based measurements coupled with integrated signal processing and data telemetry to provide real-time monitoring of tissue perfusion. The methodology and implementation are directed towards surgical and post-surgical procedures and have application to a number of additional monitoring scenarios including emergency medicine and critical care. Miniaturization will be accomplished using microfabrication techniques allowing complete implantation of the sensor system in the precise region of interest, either as a subdermal or deep tissue implant. Signal processing will be incorporated in the implanted micro-system to reduce the data communication requirements and potentially allow automated process control. A three-wavelength system will initially be designed and tested in a number of clinical scenarios to assess relative levels of perfusion and to establish clinical protocols for use of this technique. Additional capabilities for quantification of arterial and venous oxygen saturation will be developed to permit assessment of organ oxygen utilization. Biocompatible encapsulation materials will be utilized allowing long-term monitoring scenarios. The use of spread-spectrum RF data communications will both assure high-integrity data telemetry and avoid RF interference to existing medical instrumentation systems. This will also permit deployment of multiple sensors in close proximity for more comprehensive patient monitoring applications. The end goal of the project is to produce a working implantable system with well-established clinical applications and associated protocols demonstrated through animal testing. A strong collaboration of established medical, bioengineering, and engineering professionals with a published history of collaboration exists among the Principal Investigator, Mark A. Wilson, MD, PhD (University of Pittsburgh), and Lead Investigators, M. Nance Ericson, PhD (Oak Ridge National Laboratory) and Gerard L. Cote, PhD (Texas A&M University). Dr. Wilson is responsible for overall study coordination and clinical application studies. Dr. Ericson leads efforts for development of electronics, and Dr. Cote is responsible for optical sensing strategies. This collaboration provides the expertise and research facilities necessary to successfully address important clinical patient monitoring problems using a combination of medical photonics and smart medical instrumentation in a unique integrated package.