Enabling of a Wireless and Remotely Monitored Deep Brain Stimulation System through the Internet of Medical Things for Parkinson's Disease Patients

项目摘要 该项目的目标是论证一种使用超声波的新型平台技术的可行性 用于双侧脑深部刺激(DBS)的无线双向实时通信和供电 具有远程患者监控功能的系统。DBS已经成为一种成熟的神经外科手术程序， 全球共治疗了16万名患者。DBS已被证明可以改善帕金森氏病(PD)患者的质量 改善生活，加强长期震颤控制，减少运动障碍，减少多巴胺能亢进的行为 症状。与这一过程相关的一些最常见的并发症是由 导线/导线隧道、隧道导线的侵蚀或感染、导线故障/迁移以及 延长线。目前的解决方案都不是无铅的，并且由于限制而允许远程监控 体内的无线互联设备。 Bionet Sonar的软件定义的UsWB专有技术能够通过 超声波在穿透深度的组织、骨骼和液体中的穿透深度明显高于射频和 具有更高的可靠性。Bionet平台包括：i)可重新编程的无线刺激导线；ii) 可充电系统控制器，用于协调、充电和重新编程 通过超声波接口联网；iii)外部充值和通信补丁 将体内网络与互联网互连的电源/数据网关。一种智能直播设备 可由临床医生监控并提供反馈控制，以使用远程连续 实时数据将改善帕金森病的治疗选择，并为患者提供个性化的知情治疗决定 每名患者(看护点)。在此第一阶段研究中，无线供电和远程监控的可行性 将通过完成以下具体目标来演示Bionet系统： 具体目标1.在体外证明可控脑深部刺激、充电和遥控的可行性 在典型的可植入组织深度使用超声波监测组件。具体目标2. 在活体内演示受控刺激大脑期间系统的数据和能量传输。 在小型猪模型(n=3)中的活体实验将被用来证明该系统的传输能力。 从皮下控制器到起搏节点的数据和能量使用基于REAL的闭环控制 时间电感。 这项提议利用了Bionet Sonar Inc.和路易斯维尔大学的优势。我们的长期目标 成功地将Bionet Sonar系统转化为临床实践。核心平台技术可以 也适用于其他联网系统治疗不同的病因开辟了新的前沿 多模式患者治疗和使用人工智能进行患者护理。

Project Summary The objective of this project is to demonstrate feasibility of a novel platform technology using ultrasonic waves for wireless bidirectional real-time communication and powering of a Bilateral Deep Brain Stimulation (DBS) system with remote patient monitoring. DBS has become an established neurosurgical procedure with over 160,000 patients treated worldwide. DBS has been shown to improve Parkinson's disease (PD) patient quality of life, increase long term tremor control, reduce dyskinesia, and reduce hyperdopaminergic behavioral symptoms. Some of the most common complications associated with this procedure are injury caused by wire/lead tunneling, erosions or infections of the tunneled wires, lead failure/migration, and tethering of extension cables. None of the current solutions are leadless and allow for remote monitoring due to limitations of wireless interconnected devices in the body. Bionet Sonar's software-defined UsWB proprietary technology is capable of transmitting energy and data via ultrasonic waves through tissue, bone, and fluids at penetration depths significantly higher than RF waves and with greater reliability. The Bionet platform includes: i) Reprogrammable wireless stimulation leads; ii) Rechargeable system controller to coordinate with, recharge, and reprogram other implantable elements of the network through the ultrasonic interface; iii) External recharging and communication patch to act as a power/data gateway to interconnect the intra-body network with the Internet. An intelligent DBS device that can be monitored by clinicians and provide feedback control to optimize therapy using remote continuous real-time data will lead to improved PD treatment options and informed treatment decisions individualized for each patient (point-of-care). In this Phase I study, feasibility for wireless power and remote monitoring with the Bionet system will be demonstrated by completing the following Specific Aims: Specific Aim 1. Demonstrate in vitro feasibility of controlled deep brain stimulation, recharging and remote monitoring components using ultrasonic waves at typical implantable tissue depths. Specific Aim 2. Demonstrate in vivo, data and energy transmission for the systems during controlled stimulation of the brain. In vivo experiments in minipig models (n=3) will be used to demonstrate the ability of the system to transmit data and energy from the subcutaneous controller to the pacing nodes using closed loop control based on real time electrical sensing. This proposal leverages the strengths of Bionet Sonar Inc. and the University of Louisville. Our long-term goal is to successfully translate the Bionet Sonar system into clinical practice. The core platform technology may also be applied to other networked systems for the treatment of diverse etiologies opening a new frontier in multimodal patient treatment and use of Artificial Intelligence for patient care.