SBIR Phase I: Development of a novel bioabsorbable clip and applicator for rapid closure of the dura mater during open and minimally invasive spine surgery

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是开发一种新型的、生物可吸收的手术夹和涂抹器，用于在开放和微创脊柱手术中快速闭合硬脑膜。硬脑膜是覆盖大脑和脊髓的保护膜，含有脑脊液（CSF）。硬脑膜开口（硬脑膜切开）可导致脑脊液渗漏，如果不加以修复，可能导致致命的并发症，包括脊髓性头痛、假性脑膜膨出和脑膜炎。目前，硬脑膜是用精细缝线闭合的，这是一个困难且耗时的过程，需要30分钟以上的额外手术室时间。大约10%的脊柱手术采用硬膜切开术，在170万例脊柱手术中，关闭意外硬膜切开术每年花费医疗系统约4.08亿美元。使用生物可吸收夹和涂抹器系统进行硬脑膜闭合将显著提高修复率，简化临床医生的工作，减少手术时间和医疗保健系统的总体成本。这项技术的应用可以扩展到颅硬脑膜闭合，以及其他外科专业，如泌尿外科、妇产科和普通外科。提出的项目旨在开发一种生物吸收，非穿透夹快速关闭硬脑膜脊柱手术。与目前的护理标准相比，目标是生产能够关闭硬脑膜并保持水密密封的夹子。该项目将包括开发一种完全由生物相容性、生物可吸收的聚合物制成的夹子，这种聚合物在硬脑膜愈合后可以安全地在体内降解。夹子也将是放射透光的（对x射线和计算机断层扫描成像不可见），以便对手术部位进行通畅的成像。此外，夹将是非穿透性的，以避免撕裂硬脑膜，减少脑脊液泄漏的风险和可能致命的医疗并发症。该项目还旨在开发一种廉价的一次性应用器系统，该系统将应用硬脑膜闭合夹。应用器将被设计用于开放和微创手术，并将容纳夹子储存器，用于完全闭合硬脑膜，而无需将应用器从手术部位取出以重新加载。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a novel, bioabsorbable surgical clip and applicator for rapid closure of the dura mater in open and minimally invasive spine surgery. The dura mater is the protective membrane that covers the brain and spinal cord and contains cerebrospinal fluid (CSF). Openings in the dura (durotomy) can result in CSF leakage which, if not repaired, can cause potentially fatal complications including spinal headaches, pseudomeningocele, and meningitis. Currently, the dura is closed using fine suture in a difficult and time-consuming process requiring upwards of 30 minutes of additional operating room time. Durotomies occur in approximately 10% of spinal surgeries and with 1.7M spinal surgeries, closure of incidental durotomies costs the healthcare system an estimated $408M each year. Utilization of a bioabsorbable clip and applicator system for dural closure will significantly increase the rate of repair, simplify the work of clinicians, and reduce surgery time and overall costs to the healthcare system. Use of this technology could be expanded to closure of cranial dura, as well as other surgical specialties such as urology, OB/GYN, and general surgery. The proposed project aims to develop a bioabsorbable, non-penetrating clip for rapid closure of the dura mater in spine surgery. The goal is to produce clips capable of closing dura and holding a water tight seal as compared to the current standard of care. This project will include developing a clip made entirely out of a biocompatible, bioabsorbable polymer that will safely degrade in the body after the dura has healed. The clips will also be radiolucent (invisible to x-ray and computed tomography imaging) to allow for unobstructed imaging of the surgical site. In addition, the clips will be non-penetrating to avoid lacerating the dura, reducing the risk of CSF leakage and possible fatal medical complications. This project also aims to develop an inexpensive, disposable applicator system that will apply the clips for dural closure. The applicator will be designed for use in both open and minimally invasive surgery and will house a reservoir of clips for complete dural closure without removal of the applicator from the surgical site for reloading.