目的:神经假体可以通过为脊髓损伤后运动功能丧失提供替代选择来改善生活质量,中风,和其他中枢神经系统疾病。这项研究的目的是分析我们的研究小组在25年内为瘫痪志愿者安装的植入式脉冲发生器的结果,以帮助下肢功能。具体来说,为了确定存活率和常见的故障模式,删除或修改的原因,以及可能对器件性能产生不利影响的因素或外部事件。
方法:我们的植入式接收器-刺激器(IRS-8)和植入式刺激器-遥测仪(IST-12和IST-16)装置历史通过手术记录进行回顾性回顾,监管文件,以及1996年至2021年的制造记录。
结果:在43名志愿者中植入的65个装置(64.6%)中,大部分仍在植入和操作。七个因感染而进行了外植体;七个有内部故障,六个被外部事件破坏了。在移植的22个设备中,已成功替换15个收件人以恢复增强的功能。没有败血症或重大健康并发症的实例。在此期间,所有93例IRS和IST下肢研究手术之后的5例感染表明,合并感染率为5.4%。Kaplan-Meier对植入日期和最近随访之间的技术故障的分析显示,十-,20年设备生存率为92%,84%,71%,分别。
结论:故障发生率类似于,而感染率略高于,其他常见的植入式医疗设备。未来的调查将集中在预防感染上,根据接受者的人口统计数据修改技术,生活方式因素,和教育,并整合在其他应用中使用的运动神经假体的类似经验。
OBJECTIVE: Neuroprosthetic devices can improve quality of life by providing an alternative option for motor function lost after spinal cord injury, stroke, and other central nervous system disorders. The objective of this study is to analyze the outcomes of implanted pulse generators that our research group installed in volunteers with paralysis to assist with lower extremity function over a 25-year period, specifically, to determine survival rates and common modes of malfunction, reasons for removal or revision, and precipitating factors or external events that may have adversely influenced device performance.
METHODS: Our implantable receiver-stimulator (IRS-8) and implantable stimulator-telemeter (IST-12 and IST-16) device histories were retrospectively reviewed through surgical notes, regulatory documentation, and manufacturing records from 1996 to 2021.
RESULTS: Most of the 65 devices (64.6%) implanted in 43 volunteers remain implanted and operational. Seven underwent explantation owing to infection; seven had internal failures, and six were physically broken by external events. Of the 22 devices explanted, 15 were successfully replaced to restore recipients\' enhanced functionality. There were no instances of sepsis or major health complications. The five infections that followed all 93 IRS and IST lower extremity research surgeries during this period indicate a pooled infection rate of 5.4%. The Kaplan-Meier analysis of technical malfunctions between the implant date and most recent follow-up shows five-, ten-, and 20-year device survival rates of 92%, 84%, and 71%, respectively.
CONCLUSIONS: Incidence of malfunction is similar to, whereas infection rates are slightly higher than, other commonly implanted medical devices. Future investigations will focus on infection prevention, modifying techniques on the basis of recipient demographics, lifestyle factors, and education, and integrating similar experience of motor neuroprostheses used in other applications.