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

这个i-Corps项目的更广泛的影响/商业潜力是开发一种神经接口，将为患者提供直观的假肢控制。2024年，全球先进上肢假体市场的价值预计将达到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对机械手和手臂的可靠或直观的控制，同时给试图为患者提供舒适和功能的假肢的修复师带来负担。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的需求，如内科医生、外科医生、职业治疗师和保险公司，来探索神经接口技术的商业潜力。除此应用外，客户发现模型还可用于为需要控制假肢、康复或数字设备的其他患者群体验证类似的产品。这项技术不仅可能改善患者的福祉，还可以减少残疾后常见的就业轮班。它进一步推进了一个对美国保持生产力和竞争力至关重要的领域。这个i-Corps项目基于再生周围神经接口(RPNI)的开发。拟议的RPNI技术是通过在切断的神经分支的末端移植小肌肉来构建的，这些分支重新支配移植物。这项技术有三个关键的好处。首先，肌肉移植物会自然地将小的神经信号放大成大幅度的肌电图。其次，它通过防止神经瘤的形成来减少肢体疼痛。第三，它允许我们使用肌肉作为生物袖带来植入假体界面的电极。控制信号可以从神经读取，比目前的技术具有更高的功能特异性、强度和稳定性。这项技术已经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。研究表明，可以直观地控制单个手指和抓握动作，而无需频繁调整控制器或重新校准。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耐受性来受益于多关节假手。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.