Implantable Sensor for Transplant Tissue Monitoring

描述(申请人提供)：提出了一种植入式组织监测系统，以解决现有的组织灌注监测仪器在各种临床应用中的局限性。植入系统的目的是作为一种微创筛查工具，提供实时的组织灌流和氧气评估，以促使医生注意和应用既定的诊断和侵入性矫正程序，特别是在肝脏移植方面。该系统依靠基于光子学的测量以及集成的信号处理和数据遥测来提供对组织血流的实时监测。该方法和实施针对外科手术和手术后程序，并适用于一些额外的监测方案，包括紧急医疗和危重护理。微型化将使用微制造技术完成，允许在感兴趣的精确区域完全植入传感器系统，作为皮下或深层组织植入物。信号处理将被结合到植入的微系统中，以减少数据通信要求，并潜在地允许自动化过程控制。三波长系统最初将在一些临床方案中设计和测试，以评估相对灌注量，并建立使用这项技术的临床方案。将开发更多量化动脉和静脉血氧饱和度的能力，以评估器官的氧利用情况。将使用生物兼容的封装材料，从而实现长期监测。使用扩频射频数据通信既可确保数据遥测的高度完整性，又可避免对现有医疗仪器系统的射频干扰。这还将允许在近距离部署多个传感器，以实现更全面的患者监测应用。该项目的最终目标是生产一种有效的植入性系统，通过动物试验展示良好的临床应用和相关方案。在首席调查员马克·A·威尔逊医学博士(匹兹堡大学)和首席调查员M.Nance Ericson博士(橡树岭国家实验室博士)和Gerard L. 科特博士(德克萨斯农工大学)。威尔逊博士负责整体研究协调和临床应用研究。埃里克森博士领导电子学的发展，科特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，成功地解决了重要的临床患者监测问题，将医疗光子学和智能医疗仪器结合在一个独特的集成包中。

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.