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

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.