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Atraumatic and Sutureless Peripheral Nerve Coaptation Leveraging a Light-Activated Polymer Platform
Maria Pereira, PhD, Camille Legros, PhD, Emmanuel Thomas, PhD, Laura McCrum, MSc; Elisa Bitton, MSc
TISSIUM, Paris, France
IntroductionPeripheral nerve repair with traditional microsutures is associated with tissue trauma, scarring and axonal misalignment that may impact functional outcomes. This study characterizes a bioinspired, light-activated polymer platform based on poly(glycerol sebacate) acrylate (PGSA), designed to enable sutureless and atraumatic peripheral nerve repair. PGSA is a biodegradable polymer built from a combination of naturally occurring compounds, such as glycerol (the basic building block of lipids) and sebacic acid (metabolic intermediate in fatty acid oxidation).
Materials & MethodsThe PGSA-based coaptation solution is composed of a 3D printed chamber in which transected nerve ends are inserted, followed by the application and activation of a light-activated polymer that secures the chamber to the nerve ends. The mechanism of fixation to biological tissues was evaluated through scanning electron microscopy (SEM) and TOF-SIMS. Biodegradation was evaluated through in vivo and in vitro studies under physiological conditions. The evolution of the elastomeric mechanical properties of PGSA-based polymers was evaluated through tensile and compression testing at different biodegradation time points (n?12 per time point). Biocompatibility was evaluated in accordance with ISO 10993.
ResultsLight-activated PGSA becomes a flexible interface that binds through mechanical interlocking to biological tissues, as revealed by SEM and TOF-SIMS. The mechanical properties of the device stabilize the nerve-chamber interface, helping protect the regenerating nerve from deformation during early stages of healing. The polymer biodegrades via hydrolysis in a controlled manner and in a timeframe compatible with nerve regeneration as evidenced by a decrease of mass (>40% by 6mo, in vivo), modulus (>60% by 6mo, in vitro) and compressive force (> 50% by 6mo, in vitro) as a function of time. In vitro and in vivo studies demonstrated the biocompatibility and good local tissue tolerance of this polymer material with no evidence of neurotoxicity or systemic toxicity.
ConclusionsThe light-activated PGSA polymer platform binds to nerve tissues through mechanical interlocking, enabling sutureless and atraumatic nerve repair. The polymer is biocompatible in accordance with ISO 10993 and has a controlled biodegradation with a progressive change in physical and mechanical properties over time. While a first solution was designed for sutureless peripheral nerve repair, this polymer platform may be leveraged to address other unmet clinical needs.
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