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

SBIR 第一阶段：开发新型生物可吸收夹子和施药器，用于在开放式微创脊柱手术中快速闭合硬脑膜

• 批准号: 1648203
• 负责人: Rachel Dreilinger
• 金额: $ 22.5万
• 依托单位: NeuraMedica LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-15 至 2018-01-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1648203&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; novel; bioabsorbable

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.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是开发一种新型生物可吸收手术夹和施药器，用于在开放式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（硬脑膜切开术）中的开口可导致脑脊液渗漏，如果不修复，可能会导致潜在致命的并发症，包括脊髓头痛、假性脑膜膨出和脑膜炎。目前，硬脑膜采用精细缝合进行闭合，这是一个困难且耗时的过程，需要额外手术室时间长达 30 分钟以上。大约 10% 的脊柱手术中会进行硬脑膜切开术，在 170 万例脊柱手术中，意外关闭硬脑膜切开术每年会给医疗保健系统造成约 4.08 亿美元的损失。使用生物可吸收夹子和施药器系统进行硬脑膜闭合将显着提高修复率，简化临床医生的工作，并减少手术时间和医疗保健系统的总体成本。该技术的使用可以扩展到颅脑硬脑膜闭合以及其他外科专业，例如泌尿外科、妇产科和普通外科。该项目旨在开发一种生物可吸收的非穿透性夹子，用于脊柱手术中快速闭合硬脑膜。目标是生产出与当前护理标准相比能够闭合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、生物可吸收聚合物制成的夹子，在硬脑膜愈合后可以在体内安全降解。这些夹子还将是射线可透的（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无障碍成像。此外，夹子将是非穿透性的，以避免撕裂硬脑膜，从而降低脑脊液渗漏和可能致命的医疗并发症的风险。该项目还旨在开发一种廉价的一次性施用器系统，该系统将使用夹子进行硬脑膜闭合。该施药器将设计用于开放式和微创手术，并且将容纳一个夹子储存器，用于完全闭合硬脑膜，而无需从手术部位取出施药器进行重新装载。