I-Corps: Evaluating Regenerative Peripheral Nerve Interfaces for Prosthetics and Other Assistive Devices

I-Corps项目更广泛的影响/商业潜力是开发一种神经接口，为患者提供直观的假肢控制。预计到2024年，先进上肢假肢的全球市场价值将达到8.7亿美元。然而，尽管成本很高，患者对这些设备的满意度仍然很低。目前的解决方案不能提供可靠或直观的机械手和手臂控制，同时给试图为患者提供舒适和功能的假肢的义肢医生带来负担。I-Corps项目将通过测试围绕这些客户和最终用户需求的假设，以及生态系统中其他利益相关者（如医生、外科医生、职业治疗师和保险公司）的需求，探索神经接口技术的商业潜力。除了这个应用程序之外，客户发现模型还可以用于验证其他需要控制假肢、康复或数字设备的患者群体的类似产品。这项技术不仅可以改善患者的健康状况，还可以减少残疾后常见的就业转移。它进一步推进了一个对美国保持生产力和竞争力的劳动力至关重要的领域。这个I-Corps项目是基于再生周围神经接口（RPNI）的发展。所提出的RPNI技术是通过在切断的神经分支末端移植小肌肉来重建移植物。这种技术有三个关键的好处。首先，肌肉移植物自然地将小的神经信号放大成大振幅的肌电图。其次，它通过防止神经瘤的形成来减轻肢体疼痛。第三，它允许我们使用肌肉作为生物袖带植入电极作为假肢接口。与目前的技术相比，从神经中读取的控制信号可能具有更高的功能特异性、强度和稳定性。该技术已在啮齿动物和灵长类动物模型中得到验证，目前正在临床试验中进行评估。研究已经证明了对单个手指和抓握运动的直观控制，而不需要频繁的控制器调整或重新校准。如果这项技术被商业化，截肢患者可能不再需要一定数量的剩余肌肉或高度的小工具容忍度来受益于多关节假肢。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of a nerve interface that will provide patients with intuitive prosthetic control. The global market for advanced upper-limb prosthetics is expected to be valued at $0.87 billion in the year 2024. However, despite their high cost, patient satisfaction for these devices remains low. Current solutions do not provide reliable or intuitive control of robotic hands and arms while creating a burden on the prosthetist trying to provide patients with a comfortable and functional prostheses. The I-Corps project will explore the commercial potential of a nerve interfacing technology by testing the hypotheses around these customer and end-user needs, as well as the needs of other stakeholders in the ecosystem such as physicians, surgeons, occupational therapists, and insurers. Beyond this application, the customer discovery model can be used to validate similar products for other patient populations who need to control prosthetic, rehabilitative, or digital devices. This technology may not only improve the well-being of patients, but also reduce employment shifts that are common after disabilities. It further advances a field that is vital for the United States to maintain a productive and competitive workforce.This I-Corps project is based on the development of the regenerative peripheral nerve interface (RPNI). The proposed RPNI technology is built by grafting small muscles on the ends of severed nerve branches that reinnervate the grafts. This technique has three key benefits. First, the muscle grafts naturally amplify small nerve signals into large amplitude electromyography. Second, it reduces limb pain by preventing the formation of neuromas. Third, it allows us to use muscle as a biological cuff to implanting electrodes for a prosthetic interface. Control signals may be read from the nerve with higher functional specificity, strength, and stability than current technologies. This technique has been validated in rodent and primate models and is currently being evaluated in a clinical trial. Research has demonstrated intuitive control of individual finger and grasp movements without the need for frequent controller adjustments or recalibration. Should this technology be commercialized, people with amputations may no longer require a certain amount of remaining musculature or a high gadget tolerance to benefit from a multi-articulating prosthetic hands.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.