Implantable Sensor for Transplant Tissue Monitoring

描述（由申请人提供）：提出一种植入式组织监测系统，以解决各种临床应用中现有组织灌注监测仪器的局限性。植入系统旨在作为一种微创筛查工具，提供实时组织灌注和氧评估，以提示医生注意，并应用已建立的诊断和侵入性纠正程序，特别是肝移植。该系统依靠基于光子的测量，结合集成信号处理和数据遥测，提供组织灌注的实时监测。该方法和实施针对外科和手术后程序，并适用于一些其他监测情况，包括急诊和重症监护。微型化将通过微加工技术实现，可以将传感器系统完全植入感兴趣的精确区域，无论是皮下植入还是深层组织植入。信号处理将被整合到植入的微系统中，以减少数据通信需求，并可能实现自动化过程控制。一种三波长系统最初将被设计并在许多临床场景中进行测试，以评估灌注的相对水平，并建立使用该技术的临床方案。将开发用于定量动脉和静脉氧饱和度的附加功能，以允许评估器官氧利用。将使用生物相容性封装材料，允许长期监测方案。扩频射频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射频干扰。这也将允许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具有完善临床应用的可植入系统，并通过动物试验证明相关方案。首席研究员Mark A. Wilson，医学博士（匹兹堡大学），首席研究员M. Nance Ericson，博士（橡树岭国家实验室）和Gerard L. erickson之间建立了强有力的医学、生物工程和工程专业人员合作，并发表了合作历史。

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.