C3i Accell: Accelerating commercialization of a neural-enabled prosthetic hand system

项目摘要 有一个庞大的和不断增长的人口与上肢截肢的个人，他们的需要是不充分的， 目前的假手技术。我们的工作是基于这样一个概念，即假手技术， 提供与任务相关的感觉将提高感觉运动任务的熟练程度， 使用者可参与更广泛的就业及消闲活动。为了实现这一目标，自适应神经网络 系统神经功能假手（ANS-NEPH）系统是由我们实验室于年设计和开发的。 与工业和临床合作伙伴的合作。该系统使用无线控制的植入 神经刺激器和细导线纵向神经束内电极，以基于所获得的信号引起感觉 从一个装有仪器的假手的传感器上。我们有FDA的研究器械豁免， 进行纵向首次人体临床试验。第一例受试者已入组、植入、安装 系统的外部组件，并完成了2年的植入后随访期。结束时 在他参与这项研究的过程中，他选择保留该系统，现在，植入后三年多，他 继续在家中和社区使用该系统。在父母补助金中，我们将继续试验， 在其他受试者中评价临床安全性和器械功能。试验的主要结果将是 日常使用的神经激活假手系统的临床可行性证明（大于 一年）在家中或在使用无线控制的植入式刺激技术的工作场所。 虽然该系统的创建和正在进行的临床试验对该领域做出了重大贡献， 如果我们不将这项技术应用于临床并将其商业化，临床影响将严重减弱。 在C3 i Accell计划的支持下，我们计划解决除正在解决的问题之外的两个关键挑战 在母基金中，将通过将这项技术推向临床部署来增强影响， 商业化第一个挑战是开发软件，使临床医生能够编程， ANS-NEPH系统的刺激设置在临床环境中安全、有效和高效。我们将 启动临床医生软件的开发，通过使用结构化的人体模型对ANS-NEPH系统进行编程 因素工程方法与代表性用户的访谈和模型的形成性评价， 为临床医生-用户界面生成一组强大的使用相关要求。第二个挑战是 开发一种商业模式，使我们能够在神经技术和假肢领域有效运作， 商业生态系统。为此，我们将制定业务框架计划， 商业化这将包括为FDA的监管上市前批准制定策略 并在关键临床试验期间和商业化后报销。通过解决这些 挑战，我们预计我们可以大大增加成功商业化的可能性，从而 扩大父母补助金和其他联邦支持这项研究计划的临床影响。

PROJECT SUMMARY There is a large and growing population of individuals with upper-limb amputation whose needs are not fully met by current prosthetic hand technology. Our work is based on the notion that prosthetic hand technology that provides task-related sensations will increase proficiency in sensorimotor tasks and therefore allow prosthesis users to participate in a greater range of employment and leisure activities. To achieve this, the Adaptive Neural Systems neural-enabled prosthetic hand (ANS-NEPH) system was designed and developed by our lab in collaboration with industrial and clinical partners. The system uses a wirelessly-controlled implanted neurostimulator and fine-wire longitudinal intrafascicular electrodes to elicit sensations based on signals derived from sensors in an instrumented prosthetic hand. We have an investigational device exemption from the FDA to conduct a longitudinal first-in-human clinical trial. The first subject has been enrolled, implanted, fitted with the external components of the system, and has completed a 2-year post-implant follow-up period. At the conclusion of his participation in the study, he opted to keep the system and now, more than three years post-implant, he continues to use the system at home and in the community. In the parent grant, we are continuing the trial to evaluate clinical safety and device functionality in additional subjects. The primary outcome of the trial will be a demonstration of clinical feasibility of a neural-enabled prosthetic hand system for daily use (for greater than one year) at home or at the workplace that uses wirelessly-controlled implantable stimulation technology. While creation of the system and the on-going clinical trial constitute significant contributions to the field, the clinical impact will be severely muted if we do not deploy the technology in the clinic and commercialize it. With support from the C3i Accell program, we plan to address two key challenges beyond those being addressed in the parent grant that will enhance the impact by moving this technology towards clinical deployment and commercialization. The first challenge is to develop software that will enable clinicians to program the stimulation settings of the ANS-NEPH system safely, effectively, and efficiently in a clinical setting. We will initiate development of the clinician software to program the ANS-NEPH system by using a structured Human Factors Engineering approach with interviews of representative users and formative evaluations of a mock-up to produce a robust set of use-related requirements for the clinician-user interface. The second challenge is to develop a business model that will enable us to operate effectively in both the neurotechnology and prosthetic limb commercial ecosystems. For this, we will develop plans for a business framework that will enable successful commercialization. This will include preparation of strategies for regulatory pre-market approval by the FDA and for reimbursement during the pivotal clinical trial and after commercialization. By addressing these challenges, we anticipate that we can greatly increase the likelihood of successful commercialization and thereby amplify the clinical impact of the parent grant and other federal support for this research program.