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.

项目概要 该项目的目的是展示使用超声波的新型平台技术的可行性 用于无线双向实时通信和双边深部脑刺激 (DBS) 供电 具有远程患者监护功能的系统。 DBS 已成为一种成熟的神经外科手术 全球有 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 生命，增加长期震颤控制，减少运动障碍，并减少多巴胺能亢进行为 症状。与此手术相关的一些最常见的并发症是由以下原因引起的伤害： 电线/引线隧道、隧道电线的侵蚀或感染、引线故障/迁移以及束缚 延长线。由于限制，当前的解决方案都不是无引线的并且允许远程监控 体内的无线互连设备。 Bionet Sonar 的软件定义 UsWB 专有技术能够通过 超声波穿过组织、骨骼和液体的穿透深度明显高于射频波 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；二） 可充电系统控制器，用于与设备的其他植入元件进行协调、充电和重新编程 通过超声波接口联网； iii) 外部充电和通讯补丁 将体内网络与互联网互连的电源/数据网关。智能DBS设备 可以由临床医生监控并提供反馈控制，以使用远程连续技术优化治疗 实时数据将改善帕金森病治疗方案并做出个性化的明智治疗决策 每个患者（护理点）。在此第一阶段研究中，无线充电和远程监控的可行性 Bionet 系统的使用将通过完成以下具体目标来演示： 具体目标 1. 展示受控深部脑刺激、充电和远程控制的体外可行性 在典型的植入组织深度使用超声波监测组件。具体目标2。 演示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播能力 使用基于真实的闭环控制从皮下控制器到起搏节点的数据和能量 时间电感应。 该提案利用了 Bionet Sonar Inc. 和路易斯维尔大学的优势。我们的长期目标 的目标是将 Bionet 声纳系统成功转化为临床实践。核心平台技术可能 也可应用于其他网络系统，用于治疗不同的病因，开辟了新的领域 多模式患者治疗以及使用人工智能进行患者护理。