Rapid Detection of Common Failure Modes for Knee Prosthetics

 描述(由申请人提供)：Bruin Biometrics公司建议开发联合健康监测器(JHM)，这是一种创新的低风险设备，能够在目前所有可用的诊断设备之前检测到人工关节植入失败。人工关节置换术已显示出良好的临床效果。然而，失败的原因很多，包括无菌性松动、磨损、脱位、骨溶解和不良的局部组织反应，包括假瘤和广泛的组织损伤。最近与特定植入物设计相关的灾难性故障，以及对ALTR严重临床后果的日益关注，引起了美国和国外消费者权益保护团体和监管机构的关注。很明显，目前的诊断工具无法预测与某些植入物设计和/或患者特征相关的足够早期的并发症。目前的诊断方法通常不是预测性的，而是在骨和组织损伤已经发生时才能检测到关节退化，这增加了发病率、死亡率和翻修手术的严重性。Bruin生物识别公司开发了一种创新的监测设备，可以有效地监测人工关节的功能，并早期检测高危患者、植入物设计，并减少数量或至少减少严重程度 翻修手术的数量。早期发现还应使医生能够开出运动养生法、膳食补充剂、药物、早期翻修手术或其他措施，以防止进一步的损害。此外，有效的监测设备的存在将提供宝贵的反馈，使包括药物在内的治疗效果能够前所未有地量化和评估。本提案的目的是证明该设备检测特定故障模式的技术可行性。这将使用建立的体外试验台和体内人体试验对象先导研究来完成。我们的总体目标是快速交付一种能够监测人工关节状态的可穿戴系统，并为外科医生提供更准确和更早的诊断。

 DESCRIPTION (provided by applicant): Bruin Biometrics' proposes to develop the Joint Health Monitor (JHM), an innovative low risk device capable of detecting artificial joint implant failure prior to all currently available diagnostic devices. Artificial joint replacements have demonstrated excellent clinical performance. However, failures do occur due to a multitude of factors including, aseptic loosening, wear, dislocation, osteolysis, and adverse local tissue reactions (ALTR), including pseudotumors and extensive tissue damage. Recent catastrophic failures associated with specific implant designs, and increasing concern over the severe clinical consequences of ALTR, have raised the attention of both consumer advocacy groups and regulatory agencies, in the US and abroad. It is evident that current diagnostic tools have failed to predict early enough complications associated with some implant designs and/or patient's characteristics. Rather than be predictive, current diagnostic methods usually do not detect joint degradation until bone and tissue damage have already occurred, increasing morbidity, mortality and severity of revision surgeries. Bruin Biometrics has developed an innovative monitoring device that will allow effective monitoring of an artificial joint functionality and eary detection of at risk patients, implant designs and reduction of the number or at least the severity of revision surgeries. Early detection should also enable physicians to prescribe exercise regimens, dietary supplements, medication, early revision surgery or other measures to protect against further damage. Moreover, the existence of an effective monitoring device would provide invaluable feedback, enabling unprecedented quantification and evaluation of treatment efficacy including drugs. The objectives of this proposal are to demonstrate the technical feasibility of this device to detect specific failure modes. This will be accomplished using an in vitro test rig set up and an in vivo human subject pilot study. Our overall goal is to rapidly delier a wearable system capable of monitoring the status of artificial joints and provide surgeons with more accurate and earlier diagnoses.