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

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.