Internal versus External Sensing for Rotatry Blood Pumps

描述(由申请人提供)： 这一第二阶段计划的目标是开发和演示一种紧凑、高精度和易于使用的诊断系统，用于监测植入的旋转式血泵的“健康”。基于第一阶段的可喜成果，这种血泵诊断系统(BPDS)将只使用外部传感器，因此，将是完全非侵入性的，并易于扩展到许多类型和类型的泵。第二阶段的具体目标是：设计和制造供床边和办公室医生使用的集成BPDS；执行体外测试，包括“种子”故障和从运行到故障的评估，证明硬件和软件有效地从整体振动信号中提取部件故障的典型波形；以及使用BPDS观察植入的旋转式血泵的体内性能。在第二阶段开发的集成诊断技术将成为第三阶段努力将该系统应用于临床试验、最终改进和商业化的基础。最终的系统将为未来的植入式血泵接受者提供显著的优势。除了确保患者的安心外，它还将为医生提供泵健康的自动诊断，从而防止可能导致患者生命损失的灾难性故障。

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.