SBIR-STTR Award

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.

Public Health Relevance Statement:
Project Narrative Through this proposal a novel platform technology using ultrasonic waves for wireless powering and bidirectional real-time communication of a ventricular assist device will be developed. Ultrasound wideband technology will be used to create a system that doesn’t require a trans-cutaneous driveline to control and energize the pump of a ventricular assist device, thus, eliminating drive-line infections and improving quality of life of heart failure patients. This technology will not only improve patient outcomes and healthcare economics of this patient population, but may also enable other innovative therapies in other populations.

Project Terms:
Acute; Adverse event; Artificial Intelligence; Award; Benchmarking; Bluetooth; bone; Cardiovascular system; Caring; Cattle; Cause of Death; Charge; Clinical; clinical practice; clinically relevant; clinically significant; Communication; Computer software; cost; Data; data acquisition; data exchange; design; Development; Diagnostic; Electronic Health Record; Elements; Energy Transfer; Engineering; Epidemic; Etiology; experience; Family; Fatigue; Freezing; frontier; Future; Geometry; Goals; Health Care Costs; health care economics; Healthcare Systems; Heart failure; Heating; Hour; Implant; improved; in vitro Model; in vitro testing; Infection; innovation; Innovative Therapy; Institutes; Intelligence; Internet; Lead; left ventricular assist device; Legal patent; Liquid substance; Machine Learning; Medical; Modeling; Monitor; multimodality; novel; operation; Operative Surgical Procedures; outcome forecast; pathogen; Patient Care; patient population; Patient-Focused Outcomes; Patients; Penetration; Performance; Phase; phase 1 study; phase 2 study; Population; Power Sources; pre-clinical; Preclinical Testing; pressure; product development; Pump; Quality of life; radio frequency; Refractory; sensor; Site; Skin; software development; sonar; subcutaneous; Surface; System; Technology; Testing; Time; Tissues; Training; Translating; transmission process; Ultrasonic wave; Ultrasonics; Ultrasonography; United States; ventricular assist device; verification and validation; wireless communication; Wireless Technology