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

通过医疗物联网为帕金森病患者启用无线和远程监控的深部脑刺激系统

• 批准号: 9908204
• 负责人: Jorge Hernan Jimenez
• 金额: $ 32.86万
• 依托单位: BIONET SONAR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2021-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9908204
• 关键词: Acute; Address; Adoption; Architecture; Artificial Intelligence; Award; Behavioral Symptoms; Bilateral; Biomedical Engineering; Brain; Cadaver; Clinical; Clinical Engineering; Communication; Computer software; Data; Deep Brain Stimulation; Development; Devices; Dopa-Responsive Dystonia; Drops; Dyskinetic syndrome; Elements; Engineering; Epilepsy; Essential Tremor; Etiology; Failure; Feedback; Freezing; Frequencies; Geometry; Goals; Health Care Costs; Hospitals; Human; In Vitro; Industry; Infection; Injury; Innovative Therapy; Institutes; Intelligence; International; Internet; Intervention; Intrabody; Lead; Limb Prosthesis; Link; Liquid substance; Manic; Medical; Miniature Swine; Miniaturization; Modeling; Monitor; Neurosurgical Procedures; Obsessive-Compulsive Disorder; Parkinson Disease; Patient Care; Patient Monitoring; Patient-Focused Outcomes; Patients; Penetration; Performance; Peripheral Nerves; Population; Procedures; Quality of life; Research Personnel; Signal Transduction; Site; Stomach; Structure of subthalamic nucleus; Symptoms; System; Technology; Testing; Time; Tissues; Translating; Tremor; Ultrasonic wave; Ultrasonics; Universities; Wireless Technology; base; bone; clinical practice; clinically relevant; cost; data exchange; design; efficacy testing; experimental study; frontier; health care economics; implantable device; improved; improved outcome; in vitro Model; in vitro testing; in vivo; innovation; migration; monitoring device; multimodality; neuroregulation; novel; patient population; personalized decision; phase 1 study; phase 2 study; point of care; preclinical efficacy; product development; radio frequency; safety testing; software development; sonar; subcutaneous; transmission process; treatment optimization; verification and validation; wireless communication

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.

项目摘要 本项目的目的是证明一种新的平台技术的可行性，使用超声波 用于无线双向实时通信和双侧脑深部电刺激（DBS）供电 远程患者监护系统。DBS已成为一种成熟的神经外科手术， 全世界有160，000名患者接受治疗。DBS已被证明可以改善帕金森病（PD）患者的质量 增加长期震颤控制，减少运动障碍，并减少高多巴胺能行为 症状与此过程相关的一些最常见的并发症是由 导丝/电极导线隧穿、隧穿导丝的侵蚀或感染、电极导线失效/移位以及 延长电缆。目前的解决方案都不是无引线的，并且由于限制而允许远程监测 无线互联设备的能力。 Bionet Sonar的软件定义UsWB专有技术能够通过 超声波通过组织、骨和液体的穿透深度显著高于RF波， 更高的可靠性。Bionet平台包括：i）可重新编程的无线刺激电极导线; ii） 可再充电系统控制器，用于协调、再充电和重新编程 iii）外部充电和通信贴片，以充当 电源/数据网关，用于将体内网络与互联网互连。智能DBS装置 其可以由临床医生监测并且提供反馈控制，以使用远程连续 实时数据将改善PD治疗方案，并为患者提供个性化的知情治疗决策， 每一位患者（护理点）。在第一阶段研究中，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。证明受控脑深部电刺激、充电和远程的体外可行性 在典型的可植入组织深度使用超声波监测部件。具体目标2。 演示在大脑受控刺激期间系统的体内数据和能量传输。 小型猪模型（n=3）的体内实验将用于证明系统的传输能力 使用基于真实的的闭环控制从皮下控制器到起搏节点的数据和能量 时间电子感应 该提案利用了Bionet Sonar Inc.的优势。和路易斯维尔大学我们的长期目标 是将Bionet声纳系统成功地应用于临床实践。核心平台技术可以 也可以应用于其他网络系统，用于治疗多种病因，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。