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

该I-Corps项目更广泛的影响/商业潜力是开发一种旨在改善脊髓型颈椎病（CSM）手术结局的医疗器械。CSM影响超过810万美国人，由脊柱中与年龄相关的退化引起，导致严重症状，包括颈部疼痛，运动问题，在极端情况下，瘫痪。目前的标准治疗，后路颈椎减压和融合术（PCDF），使椎管不受保护，肌肉分离，经常导致并发症，包括相邻节段疾病。 提出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CSM患者术后症状和最大限度地降低脊髓病复发风险的关键因素。 通过在颈椎融合部位提供即时的结构稳定性并减少相邻节段的机械负荷，该器械可能提供潜在的有效干预。I-Corps项目基于一种医疗器械的开发，该器械旨在减少脊髓型颈椎病（CSM）治疗中传统后路颈椎减压融合术（PCDF）引起的并发症。 申报技术旨在与当前后路脊柱融合套件配合使用。铰链对可以在多个节段添加，并连接到PCDF中使用的棒上，不会妨碍手术工作流程。如果铰链对可以根据患者解剖结构进行调整，则这可以适用于将铰链对添加到中线棒和成角的多节段入路。申报器械是一种通过中心棒连接的多节段横连接，用于与现有后路脊柱融合套件集成，在棘突切除后从后方保护脊髓，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脊柱后凸。该器械用作人工棘突和铰链水平交联，可确保融合部位的结构稳定性和载荷分担，同时允许对系统进行患者特定宽度调整。该装置可以限制PCDF后脊髓压迫的风险，并解决手术后缓慢发生的肿胀和液体积聚。其目标是通过重现椎板和保持左右肌间室的分离来减少术后症状和创伤风险。该奖项反映了NSF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 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.