Novel Sutureless Coaptation Device for Peripheral Nerve Repair
Estelle Collin, PhD1, Christophe Naz, MEng1, Julien Lamazouade, MEng1, Valentina Cirillo, PhD1, Dominic Power, MD2 and Maria Pereira, PhD1, (1)Tissium, Paris, France, (2)Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom
Introduction
Despite decades of advancements in peripheral nerve research, current strategies for peripheral nerve repair fixation are limited. Sutures, the current clinical gold standard, were shown to induce damage to the nerve (fibrosis, inflammatory response) delaying nerve repair and potentially inducing the formation of neuromas (Bora et al). Fibrin glue is often used in practice as adjunct to microsurgical suture repair, reducing the number of sutures and consequently inflammatory response and repair site fibrosis (Bhatnagar et al, Bhandari et al, Sameem et al). However, fibrin glue lacks sufficient mechanical strength to be used without sutures in primary nerve repair (Sameem et al). Therefore, sutures remain the gold standard for nerve repair. Therefore, sutures remain the gold standard for nerve repair. Several adhesives developed at an academic level have not translated to clinical use (Rickett et al; Soucy et al). Here we report the development of a novel sutureless and tensionless strategy, based on a fully synthetic adhesive polymer, for peripheral nerve repair.
Materials & Methods.
The proposed sutureless and tensionless solution is composed of a coaptation-aid device, where the nerve is inserted, and an adhesive that is applied on both sides of the repair and polymerized with blue light for 30s. The fixation force of the device was evaluated ex vivo on rabbit sciatic nerves through tensile testing, and was compared to the performance of sutures, the current gold standard for nerve fixation. The biocompatibility of the device as well as its functionality were assessed in a sciatic nerve rat model with a nerve defect of 1cm by histology (H&E, Masson Trichrome, and Bodian staining), electrophysiology and grip tests.
Results
At day 0 the fixation force of our sutureless coaptation device was equivalent to that of suture repair in rabbit sciatic nerve, independently of the nerve diameter. An increase of the strength of repair was observed without detachment of the repair over a minimum period of 7 weeks in the in vivorat sciatic nerve model. Our solution showed good biocompatibility and the recovery of nerve conduction equivalent to those observed for suture repaired nerve.
Conclusions
This study shows that our novel fully synthetic device, based on a new adhesive polymer, enables the sutureless repair of peripheral nerves in a rat animal model, making it a promising alternative to the use of sutures.
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