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 cardiac resynchronization therapy (CRT) biventricular pacemaker with integrated ventricular pressure sensors. 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. Cardiac resynchronization therapy and home monitoring of vascular pressure through implantable wireless devices have shown to improve patient outcomes and reduce hospitalization of heart failure patients. None of the current solutions connect CRT treatment to remote monitoring due to limitations of wireless interconnected devices within the body. BionetÂ’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 radio frequency (RF) waves and with greater reliability. The Bionet platform includes: i) 2 Reprogrammable wireless pacing nodes coupled to MEMS pressure sensors; 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 CRT device that can be remotely monitored by clinicians in order to optimize therapy using continuous real-time data will lead to improved HF 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 pacing, recharging, and pressure sensing elements using ultrasounds at typical implantable tissue depths. Specific Aim 2. Demonstrate in vivo data and energy transmission for the system, allowing for controlled cardiac pacing using real time blood pressure data. In vivo experiments in porcine models (n=4) will be used to demonstrate the ability of the system to transmit data and energy from the subcutaneous controller to the pacing nodes and acquire real time intraventricular pressure data. This proposal leverages the strengths of Bionet and the Cardiovascular Innovation Institute. Our long-term goal is to successfully translate the BionetÂ’s 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.
Public Health Relevance Statement: Project Narrative Through this proposal a wireless remotely monitored bi-ventricular pacing devices will be developed using new core technology for the internet of medical things. Ultrasound wideband technology will be used to allow communication between the different implantable elements and recharge those same elements allowing for miniaturization. This technology will not only improve patient outcomes and healthcare economics of the heart failure patient population, but may also enable other innovative therapies in other populations.
Project Terms: Acute; Artificial Intelligence; Award; Blood; Blood Pressure; Blood Vessels; bone; Cadaver; cardiac pacing; cardiac resynchronization therapy; Cardiovascular system; Clinical; clinical practice; clinically relevant; Communication; Computer software; Coupled; Data; data exchange; design; Development; Devices; Diagnostic; Early Diagnosis; Elements; Engineering; Epidemic; Etiology; experimental study; Failure; Family; Family suidae; Freezing; frontier; Goals; Health Care Costs; health care economics; Healthcare Systems; Heart; Heart failure; Home environment; Hospitalization; hospitalization rates; Human; Implant; implantable device; improved; In Vitro; in vitro Model; in vitro testing; in vivo; Incidence; Industry; innovation; Innovative Therapy; Institutes; Intelligence; Internet; Intrabody; Lead; Left; Legal patent; Limb Prosthesis; Link; Liquid substance; Medical; Medical Device; Miniaturization; Modeling; Modification; Monitor; mortality; multimodality; Myocardium; neuroregulation; novel; outcome forecast; Pacemakers; Patient Care; patient population; Patient-Focused Outcomes; Patients; Penetration; Performance; personalized decision; Phase; phase 1 study; phase 2 study; Physiologic intraventricular pressure; point of care; Population; pre-clinical; Preclinical Testing; pressure; pressure sensor; product development; Public Health Informatics; Quality of life; radio frequency; software development; sonar; Stomach; subcutaneous; System; Systolic heart failure; Technology; Testing; Therapeutic; Time; Tissues; Translating; transmission process; Treatment Failure; treatment optimization; Tremor; Tricuspid Valve Insufficiency; Ultrasonic wave; Ultrasonics; Ultrasonography; United States; Ventricular; verification and validation; Wireless Technology; Work
