I-Corps: A medical device to shield the spinal cord and provide structural stability following decompression and fusion procedures

这个i-Corps项目的更广泛的影响/商业潜力是开发一种医疗设备，旨在改善脊髓型颈椎病(CSM)手术的结果。CSM影响着超过810万美国人，是由脊柱中与年龄相关的退化引起的，导致严重的症状，包括颈部疼痛、运动问题，在极端情况下还会导致瘫痪。目前的标准治疗是颈椎后路减压融合术(PCDF)，椎管无保护，肌肉无连接，经常导致包括邻近节段疾病在内的并发症。这项拟议的技术旨在提供一种有效的解决方案，以防止术后脊髓压迫--这是减少脊髓型颈椎病患者术后症状和最大限度减少复发脊髓病风险的关键因素。通过在颈椎融合部位提供即时的结构稳定性并减少邻近节段的机械负荷，这种拟议的装置可能提供一种潜在的有效干预。这项I-Corps项目基于一种医疗装置的开发，该装置旨在减少脊髓型颈椎病(CSM)治疗中传统的颈椎后路减压融合(PCDF)手术所产生的并发症。建议的技术被设计用于目前的后路脊柱融合成套设备。铰链对可以在多个水平上添加，并连接到PCDF中使用的杆上，不会阻碍手术工作流程。如果铰链对可以根据患者的解剖结构进行调整，这可以适用于多节段入路，其中将铰链对添加到中线棒和角度。该装置是一个通过中央棒连接的多水平交联器，与现有的后路脊柱融合器整合在一起，在去除棘突后保护脊髓后方，为融合结构提供稳定性，并重建中线龙骨，以防止术后肌肉回忆和后凸。该装置作为人工棘突和铰链水平交叉链，确保融合部位的结构稳定性和负荷分担，同时允许对系统进行患者特定的宽度调整。该装置可以限制PCDF后脊髓受压的风险，并解决手术后缓慢起病的肿胀和液体积聚。其目标是通过重述椎板和保留左右肌肉间的分离来减少术后症状和创伤风险。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 medical device aimed at improving the outcomes of surgeries for cervical spondylotic myelopathy (CSM). CSM affects over 8.1 million Americans, and is caused by age-related degeneration in the spinal column, leading to severe symptoms including neck pain, motor issues, and in extreme cases, paralysis. The current standard treatment, posterior cervical decompression and fusion (PCDF), leaves the spinal canal unprotected and the muscles unattached, often resulting in complications including adjacent segment disease. The proposed technology is designed to provide an effective solution to prevent spinal cord compression post-operation - a critical factor in reducing postoperative symptoms and minimizing the risk of recurrent myelopathy for patients with CSM. By providing immediate structural stability at the cervical fusion site and reducing the mechanical load on neighboring levels, this proposed device may offer a potentially impactful intervention.This I-Corps project is based on the development of a medical device designed to reduce complications arising from traditional posterior cervical decompression and fusion (PCDF) surgeries in cervical spondylotic myelopathy (CSM) treatment. The proposed technology is designed to be utilized with current posterior spinal fusion kits. The hinge pairs can be added at multiple levels and are attached to the rods used in PCDF, not impeding the surgical workflow. This can be suited for multilevel approaches where hinge pairs are added to the midline rod and angulation, if the pairs can be adjusted according to patient anatomy. The proposed device is a multi-level crosslink connected via a central rod for integration with present posterior spinal fusion kits that protects the spinal cord posteriorly after removal of the spinous processes, provides stability to the fusion construct, and reestablishes the midline keel to prevent muscle recollection and kyphosis postoperatively. The device serves as an artificial spinous process and hinged horizontal crosslinks that ensure structural stability and load-sharing at the fusion site while allowing for patient-specific width adjustments of the system. The device may limit the risk of spinal cord compression after PCDF and address the slow-onset swelling and fluid accumulation following operation. The goal is to reduce postoperative symptoms and trauma risk by recapitulating the lamina, and retaining separation of the left and right muscle compartments.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.