Developing Implantable Miniature Temperature Sensors for Cryosurgery Control

描述(申请人提供)：为了评估和控制热手术，提出了无线植入式温度传感器的开发。热手术或对不受欢迎的生物组织(如癌症)的热破坏可以通过冷冻(也称为冷冻外科)或加热实现，例如高频超声波(HIFU)、射频消融(RFA)、激光探头和交流磁场中的磁性纳米颗粒。热手术本质上是一种微创手术，它的成功应用取决于测量关键位置的温度并实时重建温度场的能力。这项研究的目标是使温度场实时重建成为现实。在目前的探索性研究中，建议对两个关键要素进行概念验证：一个是微型无线温度传感装置，另一个是将从多个传感器收集的温度数据转换到重建的温度场的方法。虽然这项建议使用前列腺冷冻外科作为研究模型，但这项研究的结果可以转化为医学上的其他热疗方式。新温度传感单元的突破性概念设计源于电子小型化和无线通信的进步。传感单元设计由三个主要组件组成：温度传感核心、无线收发器和电源线。该系统设计的创新有四个方面：(I)传感器是超微型的--被植入到米粒大小的单片硅片上；(Ii)传感器是无源的，通过无线感应耦合的方式接收电能；(Iii)多个传感器可以同时与一个数据接收器通信；以及(Iv)可以在成像引导下进行传感器定位，例如，类似于近距离放射治疗(前列腺的局部放射治疗)中的放射种子定位。这项探索性研究提出了三个具体目标：(1)开发一种无线温度传感单元，包括具有片上感应耦合功率调节的硅植入物、温度传感器和无线通信接口；(2)使用前列腺冷冻外科模拟器来演示对体模材料进行温度传感的可行性，这是一个成熟的实验测试平台，旨在创建模拟前列腺冷冻手术的2D热场；以及(3)开发一种用于低温外科应用的实时温度场重建的数学技术。拟议的研究领域的更广泛影响远远超过温度监测的应用，在温度监测中，远程电力激励与无线通信相结合，可以作为传感器电池的平台，并用于广泛的医疗应用。 公共卫生相关性：本研究的目标是开发一种无线植入式温度传感器，用于热手术的反馈和控制。这项研究提出了两个关键要素：微型无线温度传感器和一种从多个传感器收集数据的方法，用于温度场重建。虽然这项建议使用冷冻手术(即通过冷冻破坏组织)作为研究模型，但这项研究的结果预计将转化为高温热手术应用，如高频超声波、射频和激光探头。

DESCRIPTION (provided by applicant): The development of wireless implantable temperature sensors is proposed, for the purpose of evaluation and control of thermal surgery. Thermal surgery, or the thermal destruction of undesired biological tissues- such as cancerous tumors-can be achieved by either freezing (also known as cryosurgery), or by heating, with the examples of high frequency ultrasound (HIFU), radio-frequency ablation (RFA), laser probes, and magnetic nanoparticles in an AC magnetic field. Thermal surgery is a minimally invasive procedure by nature, where its successful application is dependent upon the ability to measure temperatures at critical locations and reconstruct the temperature field in real time. The goal in this line of research is to make temperature-field reconstruction in real time a practical reality. Proof-of-concepts for two key elements are proposed to be developed in the current exploratory study: a miniature wireless temperature-sensing unit and a method to translate temperature data-collected from multiple sensors-to a reconstructed temperature field. While this proposal uses cryosurgery of the prostate as a research model, results of this study are translational to other thermal modalities in medicine. The groundbreaking conceptual design of the new temperature-sensing unit originates from advances in electronics miniaturization and wireless communication. The sensing-unit design consists of three main components: a temperature-sensing core, a wireless transceiver, and a power link. The innovation in this system design is four-fold: (i) the sensor is ultra-miniature-being implanted on a monolithic piece of silicon, where the sensor is of a rice-grain size; (ii) the sensor is passive, receiving its electrical power by means of wireless inductive coupling; (iii) many sensors can communicate simultaneously with a single data receiver; and, (iv) sensor localization can be done under imaging guidance, for example, similarly to radiation seeds localization during brachytherapy (local radiation treatment of the prostate). Three specific aims are set forth in this exploratory study: (1) to develop a wireless temperature-sensing unit, comprising a silicon implant with on-chip inductively-coupled power regulation, a temperature sensor, and a wireless communication interface; (2) to demonstrate feasibility of temperature sensing on a phantom material, using a prostate-cryosurgery simulator, which is an established experimental testing platform, designed to create a 2D-thermal field simulative of prostate cryosurgery; and, (3) to develop a mathematical technique for real-time temperature-field reconstruction for cryosurgery applications. The wider impact of the proposed line of research far exceeds the application of temperature monitoring, where remote power excitation, combined with wireless communication, can serve as a platform for a battery of sensors, and for a wide range of medical applications. PUBLIC HEALTH RELEVANCE: The objective of this study is to develop a wireless implantable temperature sensor for the purpose of feedback and control of thermal surgery. Two key elements are proposed to be developed in this study: a miniature wireless temperature sensor and a method to collect data from multiple sensors, for temperature field reconstruction. While this proposal uses cryosurgery (i.e., the destruction of tissue by freezing) of the prostate as a research model, the outcomes of this study are expected to be translational to high-temperature thermal-surgery applications, such as high-frequency ultrasound, radio-frequency, and laser probes.