New Tools in the Nerve Repair Toolbox: A Light-Activated Sutureless Coaptation System
Estelle Collin, PhD1, Christophe Naz, MEng1, Valentina Cirillo, PhD1, Joanna Xylas, PhD2, Youssef Biadillah, MEng1, Dominic Power, MD3 and Maria Pereira, PhD1, (1)Tissium, Paris, France, (2)Tissium, Boston, MA, (3)Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom
Introduction
Despite decades of research on bioadhesives as alternatives to sutures, few are available to and have been optimized for nerve repair. While fibrin glue is often used in nerve repair as an adjunct to microsurgical suture, it lacks sufficient mechanical strength to be used alone in areas of tension. This study evaluates a new sutureless nerve coaptation system that employs a novel bioadhesive polymer derived from a CE-marked polymer used as a vascular sealant (TISSIUM; Paris, France). The coaptation system consists of a bioresorbable hollow guide and the novel bioadhesive polymer, which is applied as a viscous liquid and rapidly photocured with blue light to achieve a soft and flexible, but strong fixation.
Materials & Methods.
Fixation strength of the sutureless nerve coaptation system at time of surgery was compared to 9-0 nylon sutures through ex-vivo evaluation in rat sciatic nerves (no gap) and in digital cadaveric nerves through tensile testing (no gap). To assess performance over time, the nerve coaptation system was applied to rat sciatic nerve injuries (n=30, 1cm gap) and compared to collagen nerve tubes secured in place with two 9-0 nylon sutures (n=30, 1cm gap). Repair strength, polymer biocompatibility as well as efficiency of nerve repair were assessed with tensile testing, toxicity evaluation, electrophysiology, gastrocnemius weight, and histology (H&E, Trichrome, Bodian) at 1, 3, and 6 months post-surgery. Qualitative feedback on the coaptation system application was collected.
Results
The fixation strength of the coaptation system was equivalent to suture repair in both rat and cadaveric models, independent of nerve diameter. Over time, for nerves repaired with the coaptation system, we observed an increase in nerve repair strength with a biocompatible tissue response to the polymer. Furthermore, reinnervation of the sciatic nerve through an increase in conduction of motor nerve fibers was observed at 3 months and increased through 6 months, which is confirmed by an increase of gastrocnemius muscle weight (3 to 6 months). Early sensory reinnervation of the distal sural dermatomes was noted at 1 month and continued to 6 months, with almost native velocities (~90% of intact nerve conduction velocity values).
Conclusions
A sutureless nerve coaptation system that employs a novel bioadhesive polymer offers a promising alternative to microsutures for strong and effective sensory and motor nerve repair. Clinical studies can further elucidate the potential of this unique nerve repair system.
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