Development of a novel bioabsorbable clip and applier for rapid closure of the dura mater in open and minimally invasive spine surgery.

PROJECT SUMMARY ABSTRACT This Small Business Innovation Research Phase II project supports the development of a novel bioabsorbable surgical clip and applier for rapid closure of the dura mater in open and minimally invasive spine surgeryThe dura mater is the protective membrane that covers the brain and spinal cord and contains cerebrospinal fluidCSFOpenings in the duradurotomycan result in CSF leakage whichif not repairedcan cause potentially fatal complications including spinal headachespseudomeningoceleand meningitisCurrentlythe dura is closed using fine suture in a difficult and time consuming process requiring an average ofminutes of additional operating room timeDurotomies occur in approximatelyof spinal surgeries and withM spinal surgeriesclosure of incidental durotomies costs the healthcare system an estimated $M each year in time aloneIn Phase Ia novel dural clip was developed and underwent proof of concept and feasibility bench testingPhase II research will seek to complete development of the dural clip and applier and to perform preclinical testing of the dural clip systemThese objectives will be accomplished through the following proposed specific aimsComplete development of the dural clip applier and cartridge systemDetermine the effect of e beam radiation sterilization on clip mechanical properties and agingCharacterize the absorption and biocompatibility of the dural clip device in an in vivo rat modelandAssess dural clip function in a large animal functional pilot studyNeuraMedica will work with a regulatory consultant and the FDA to ensure each step meets regulatory requirementsSuccessful completion of this NIH Phase II project will allow for the translation of our research findings to a commercially available device that will improve durotomy repair PROJECT NARRATIVE Traumatic and surgical openings in the dura mater can result in cerebrospinal fluid leakage whichif not repairedcan cause wound breakdownspinal headachesinfectionmeningitisand other potentially fatal complicationsClosure of dural openings is time consuming and labor intensive as it involves the use of very fine sutureoften while working through narrow corridors with limited visibility and accessThis Small Business Innovation Research Phase II project supports the development of a novel dural clip and applier for rapid closure of the dura mater in open and minimally invasive spinal surgery that will increase the rate of repairsimplify the work of cliniciansand reduce surgery time and overall costs to the healthcare system