Wireless ultrasonic powering and monitoring of Left Ventricular Assist Devices through the Internet of Medical Things

通过医疗物联网对左心室辅助装置进行无线超声波供电和监测

• 批准号: 10007683
• 负责人: Jorge Hernan Jimenez
• 金额: $ 46.9万
• 依托单位: BIONET SONAR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10007683
• 关键词: Acute; Adverse event; Artificial Intelligence; Award; Benchmarking; Bluetooth; Cardiovascular system; Caring; Cattle; Cause of Death; Charge; Clinical; Communication; Computer software; Data; Development; Diagnostic; Electronic Health Record; Elements; Energy Transfer; Engineering; Epidemic; Etiology; Family; Fatigue; Freezing; Future; Geometry; Goals; Health Care Costs; Healthcare Systems; Heart failure; Heating; Hour; Implant; Infection; Innovative Therapy; Institutes; Intelligence; Internet; Lead; Legal patent; Liquid substance; Machine Learning; Medical; Modeling; Monitor; Operative Surgical Procedures; Patient Care; Patient-Focused Outcomes; Patients; Penetration; Performance; Phase; Population; Power Sources; Preclinical Testing; Pump; Quality of life; Refractory; Site; Skin; Surface; System; Technology; Testing; Time; Tissues; Training; Translating; Ultrasonic wave; Ultrasonics; Ultrasonography; United States; Wireless Technology; bone; clinical practice; clinically relevant; clinically significant; cost; data acquisition; data exchange; design; experience; frontier; health care economics; improved; in vitro Model; in vitro testing; innovation; left ventricular assist device; multimodality; novel; operation; outcome forecast; pathogen; patient population; phase 1 study; phase 2 study; pre-clinical; pressure; product development; radio frequency; sensor; software development; sonar; subcutaneous; transmission process; ventricular assist device; 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 powering and bidirectional real-time communication of a left ventricular assist device (LVAD). Heart failure (HF) has become a challenge of epidemic proportions to the healthcare system in the United States with poor prognosis for patients and elevated healthcare costs. LVADs are standard surgical therapy for advanced HF patients refractory to medical management. Despite extensive training and daily care, LVAD recipients still experience driveline infections (14-28%) at an annual cost of $20,000 and represents a clinically- significant adverse event and one of the primary causes of death. Transcutaneous energy transmission systems (TETS) are being developed to eliminate the LVAD’s driveline. Currently, TETS technology is limited by (1) low energy transfer efficiency, (2) power loss due to coil misalignment, (3) reduced data transmission rates with increasing depth of penetration, and (4) heating of tissue. Bionet Sonar’s software-defined ultrasonic wide band (UsWB) proprietary technology is capable of transmitting energy and data via ultrasonic waves through tissue, bone, and fluids at penetration depths significantly greater than RF waves and with greater reliability. Since increasing energy efficiency results in reduced energy storage requirements UsWB also enables reduction in size of implantable technologies. Bionet’s UsWB TETS (UTET) system includes: (1) energy transfer portal with internal and external intelligent piezo array-surfaces, (2) implantable controller with energy storage capacity, (3) external controller with IoMT portal, and (4) wearable power supply. These elements will enable wireless LVAD operation over wide range of clinical conditions with real-time data acquisition and diagnostics. Proof-of-concept for Bionet’s core technology was tested in vitro, demonstrating superior data transmission compared to RF (700kHz, 180kbit/s, 20cm tissue depth) and ultrasonic wireless recharging. In this Phase I study, feasibility of the fully-integrated wireless, UTET system for LVAD support will be demonstrated by completing the following specific aims: Specific Aim 1: Design and fabricate fully-integrated UTET system and demonstrate feasibility with clinical- grade LVAD in an in vitro model that mimics clinically-relevant implantable tissue depths and geometries. Specific Aim 2: Demonstrate feasibility of the fully-integrated UTET system with clinical-grade LVAD in an acute bovine model (n=2) at flow rates of 1-5 L/min for up to 8 hours. This proposal leverages the strengths of Bionet and the Cardiovascular Innovation Institute. Our long-term goal is to successfully translate the Bionet’s UTET 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 用于左心室辅助装置（LVAD）的无线供电和双向实时通信。 心力衰竭（HF）已成为美国医疗保健系统面临的流行性挑战 患者预后差，医疗费用增加。LVAD是标准的外科治疗， 药物治疗难治的晚期HF患者。尽管有大量的训练和日常护理， 接受者仍然经历传动系感染（14-28%），每年花费20，000美元，并且代表临床上- 严重不良事件和死亡的主要原因之一。经皮能量传输系统 （TETS）正在开发，以消除LVAD的传动系统。目前，TETS技术受到以下限制：（1）低 能量传输效率，（2）由于线圈未对准而导致的功率损耗，（3）由于 增加穿透深度，和（4）加热组织。 Bionet Sonar的软件定义超声波宽带（UsWB）专有技术能够传输 通过超声波在穿透深度处穿过组织、骨和液体， 比RF波更大，并且具有更高的可靠性。由于提高能源效率会减少 能量存储要求UsWB还能够减小可植入技术的尺寸。Bionet's UsWB TETS（UTET）系统包括：（1）具有内部和外部智能压电的能量传输门户 阵列表面，（2）具有能量存储能力的植入式控制器，（3）具有IoMT门户的外部控制器， （4）可穿戴电源。这些元件将使无线LVAD操作在广泛的 实时数据采集和诊断的临床条件。Bionet核心技术的概念验证 在体外进行了测试，证明了与RF（700 kHz，180 kbit/s，20 cm组织）相比具有上级数据传输性能 深度）和超声波无线充电。在第一阶段的研究中，完全集成的无线， 将通过完成以下具体目标来证明用于LVAD支持的UTET系统： 具体目标1：设计和制造完全集成的UTET系统，并通过临床试验证明其可行性。 在体外模型中模拟临床相关的可植入组织深度和几何形状。 具体目标2：证明完全集成的UTET系统与临床级LVAD在 急性牛模型（n=2），流速为1-5 L/min，持续8小时。 该提案充分利用了Bionet和心血管创新研究所的优势。我们的长期目标 成功地将Bionet的UTET系统转化为临床实践。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。