Surgical Tool to Minimize CSF Leakage Post Durotomy

Introduction: Surgical insult to the spinal dura can cause cerebrospinal fluid (CSF) leakage, which affects an estimated 100,000 patients per year2. Sutures, dural “glues”, and biomaterials are the most common treatments, but risk breaking once the patient begins moving, leading to CSF leak and clinical sequelae (i.e. postural headache). Thus, there is a need for a more reliable intraoperative method of closing dural tears in patients undergoing spinal procedures to reduce the incidence of corrective surgery.

Methods: Our device rapidly deploys an inverted umbrella apparatus to deploy a biomaterial membrane, or “patch”, beneath the torn dura to prevent CSF leakage from the inside. The device fabrication process involves weaving a network of wires into upper and lower retaining rings and adding the membrane to the wire network. The membrane is deployed subdurally, pressure is applied to seal the patch, and finally the wire network is retracted and removed.

Results: The dural deployment device was able to successfully deploy the biomaterial membrane much faster than traditional (manual) deployment methods and create a functional barrier to leakage, in a simulated dural tear; however, the presence of fluid led to significant cohesion of the biomaterial membrane to the device wires, increasing deployment time. Variation in fabrication strategy resulted in greater efficiency construction, and altered membrane deployment angles allowing greater maneuverability.

Conclusion : The current standard of care lacks a high-fidelity solution to prevent CSF leakage secondary to dural tears. Additionally, there is variability and a lack of a universal technique applicable to different morphologies. One opportunity for innovation involves developing a device for efficiently and uniformly sealing these dural tears. The described prototype demonstrates an ability to deploy a biocompatible dural sealing material. Further steps in iteration include utilizing a more hydrophobic membrane, miniaturizing the device for greater navigability in the extramedullary environment, improving the deployment mechanism, and quantifying leakage reduction via image acquisition.