SBIR-STTR Award

Cardiac assist devices are increasingly being used for long term support. As patient survival times increase substantially, long-term management of the patients will increasingly play a role in suitability of these devices as destination therapies. Infection, primarily due to cable entry site(s), remains a primary complication for these patients. To-date, the only practical approach to completely eliminate long-term issues associated with cable entry site infections is to use a TET (Transcutaneous Energy Transfer) system. A TET system, is an electro-magnetic power transfer system, which can send substantial electrical power across a patient's intact skin, thereby eliminating cable entry site infections. The ultimate objective of the research proposed here is to develop a fail-safe TET system with substantial reduction in power transfer sensitivity to patient movement. ABIOMED has already developed a first-generation TET system currently in use in the clinical trial of the AbioCor total artificial heart. This system, although highly effective in a clinical setting, has demonstrated the need for a fail-safe operation as well as for reduced sensitivity to patient movement. Starting with the current ABIOMED TET as a base, detailed studies in phase I will develop a novel, fail-safe TET system and fully characterize its performance. The need for a trouble free, user friendly TET system is already very visible, and will become increasingly important as more patients are discharged home with destination cardiac support prostheses. For these patients a robust, lightweight, complication-free power source will play a critical role in achieving a near-normal quality of life.

Thesaurus Terms:
assistive device /technology, biomedical device power system, biomedical equipment safety, circulatory assist, technology /technique development body movement, quality of life

The ultimate objective of this proposed program is the commercialization of a universal transcutaneous energy transfer (TET) system with a high performance implantable battery. This integrated power system will be adaptable to a host of next generation fully implantable mechanical circulatory support (MCS) systems. To date, fully implantable systems (i.e. the combination of an implantable electric MCS system and a TET system allowing electrical power transfer across the intact skin) appear to be the most promising approach to eliminating the risk of exit site infection altogether. Most MCS systems in clinical use today require either cannulae (if the blood pump is extracorporeal) or drivelines (if the blood pump is intracorporeal) to cross the patient's skin. With such percutaneous designs, infection at the exit site is a primary cause of morbidity and mortality during long term management of patients. Under Phase I of the program, the feasibility of the digital, fault-tolerant TET system was demonstrated. Abiomed's analog TET system for the FDA-approved AbioCor Implantable Replacement Heart was redesigned using digital circuits, enhanced for fault-tolerance, and reconfigured for improved spatial coupling. Digital versions of both the implanted TET (iTET) and external TET (eTET) electronics were prototyped and tested. A preferred TET configuration was then selected as the basis for the Phase II program. Under the proposed Phase II program, Abiomed's key innovation will be a universal TET system, integrated with an implantable battery pack having very high capacity (60 Wh) and cycle life (>1,000 charge/discharge cycles). A digital, fault-tolerant TET architecture and novel solid state lithium battery chemistry will be employed. Sold as an original equipment manufacturer (OEM) product, this flexible power system will bring the survival and quality of life benefits of fully implantable technology to an increased number of patients through a host of MCS systems. Under the continued program, the design and feasibility testing of the universal TET system will be completed. Based on the success of our Phase II program, private funding would enable further development and design qualification activities in anticipation of commercial launch of the universal TET product. Abiomed would partner with at least one other company to integrate the universal TET system into the partner's MCS system; transfer the universal TET system to manufacturing and produce clinical units for the partner; and provide technical support while the partner completes system-level safety & compliance testing, conducts clinical trials, and seeks regulatory approval for its MCS system. PUBLIC HEALTH NARRATIVE: Existing schemes for powering implantable mechanical circulatory support (MCS) systems pose the risk of infection at cable exit sites, particularly during long term use. Transcutaneous energy transmission (TET) systems reduce this risk by delivering electrical power across the intact skin, but this technology has not yet come into widespread use. The universal TET system and high performance implantable battery proposed in this research would offer a general purpose, highly reliable means of powering a host of next generation MCSSs. This original equipment manufacturer (OEM) product would therefore both improve patient quality-of-life and enhance commercialization of MCS technology for long term applications.

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