Internal versus External Sensing for Rotatry Blood Pumps

DESCRIPTION (provided by applicant): The goal of this Phase II program is to develop and demonstrate a compact, highly accurate, and easy-to-use diagnostic system for monitoring the "health" of implanted rotary blood pumps. Based on promising results from Phase I, this blood pump diagnostic system (BPDS) will use only external sensors and, therefore, will be completely nonintrusive and readily extensible to many styles and types of pumps. The Phase II specific aims are to: design and fabricate an integrated BPDS for bedside and in-office physician use; perform in-vitro tests, including "seeded" fault and run-to-failure evaluations demonstrating that the hardware and software effectively extracts the waveforms typical of component failures from the overall vibration signal; and use the BPDS to observe the in-vivo performance of implanted rotary blood pumps. The integrated diagnostics developed in Phase II will be the basis for a Phase III effort applying the system in clinical trials, final refinement and commercialization. The final system will offer significant advantages to future recipients of implanted blood pumps. In addition to ensuring a patient's peace of mind, it will provide physicians with an automatic diagnosis of a pump's health, thereby preventing catastrophic failures that could cost the patient's life.