SGER: Leading Indicators of Failure for Implantable Biological-Systems

SGER：可植入生物系统失败的先行指标

• 批准号: 0740012
• 负责人: Pradeep Lall
• 金额: --
• 依托单位: Auburn University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2009-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0740012&HistoricalAwards=false
• 关键词: SGER; Leading; Indicators; Failure; Implantable

Intellectual Merit Published studies based on FDA and non-FDA data have documented implanted pacemaker and ICD device failures, several thousands advisories, and an increasing rate of recall. Dominant failure modes have been identified to include capacitor, connector, and electrical anomalies. Currently, built-in self test methods diagnose failure based on reactive fault-detection. Assessing the system-level damage-state and residual-life beyond the state-of-art because of variations in environmental conditions and personal usage patterns. Usage factors that can impact the life of a medical system, include, programmed parameter factor variations in the rate, amplitude, pulse width, shock energy, and mode (number of chambers paced); patient factors such as unique therapy needs (shock frequency, percent paced), lead impedances, and pacing/shocking thresholds. The proposed detection of early indicators of system degradation can signal impending failure and help impact system replacement before failure.Broader ImpactThe proposed effort has the potential for broad impact in implantable medical devices, pacemakers for treating conduction disorders such as bradycardia; defibrillators to treat ventricular and atrial tachyarrhythmia and fibrillation; muscle stimulators to treat urinary incontinence, fecal incontinence, and gastroparesis; neurological stimulators to treat Parkinson's disease; cochlear implants to treat hearing disorders; drug pumps for pain management. The broader impact and outreach activities will include: (a) Initiation of undergraduate students, women and under-represented minorities in research; (b) Partnership with the Women's Leadership Institute at Auburn University; (c) Organization of a topical-session at the ASME Congress (IMECE); (d) Technology transfer to leading manufacturers including Medtronic; (f) Introduction of K-12 school children to biological electronics through lab tours and in-class presentations.

基于FDA和非FDA数据的已发表研究记录了植入式起搏器和ICD器械故障、数千例故障和不断增加的召回率。已确定主要失效模式包括电容器、连接器和电气异常。目前，内建自测试方法基于反应式故障检测来诊断故障。评估由于环境条件和个人使用模式的变化而超出最新技术水平的系统级损坏状态和剩余寿命。可能影响医疗系统寿命的使用因素包括：频率、振幅、脉冲宽度、电击能量和模式（起搏腔室数量）中的程控参数因素变化;患者因素，如独特治疗需求（电击频率、起搏百分比）、电极导线阻抗和起搏/电击阈值。所提出的系统退化的早期指标的检测可以发出即将发生的故障的信号，并有助于在故障前影响系统更换。更广泛的影响所提出的努力有可能在植入式医疗设备，用于治疗传导障碍，如心动过缓起搏器;治疗室性和房性快速性心律失常和纤维性颤动的起搏器;治疗尿失禁，大便失禁和胃轻瘫的肌肉刺激器;治疗帕金森氏病的神经刺激器;治疗听力障碍的人工耳蜗;用于疼痛管理的药物泵。更广泛的影响和外联活动将包括：（a）启动大学生、妇女和代表性不足的少数民族参与研究;（B）与奥本大学妇女领导研究所建立伙伴关系;（c）在美国机械工程师协会大会上组织一次专题会议;（d）向包括美敦力在内的主要制造商转让技术;（f）通过实验室图尔斯参观和课堂演示，向K-12学龄儿童介绍生物电子学。