Development of tubular silk conduits for housing nerve-regenerating silk fibres

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Damage to peripheral nerves through trauma and cancer surgery results in loss of function and significant morbidity worldwide. There are currently no implantable devices for peripheral nerve injury (PNI) as effective as the gold standard autologous nerve grafts. However, these are expensive to perform, require sacrificial nerves from a donor site in the patient and have limited success. Thousands of these procedures are performed each year and cause harm through the loss of the donor nerve and carry high risk of morbidity for transplanted nerves and chronic pain from tangled nerves. In addition, there are many cases, particularly where PNI is from direct trauma, where it is not possible to use an autograft, but an alternate off-the-shelf stent could be used.Our first (IP protected) product is a peripheral nerve repair bridge with a standardised design that will be available off-the-shelf in a range of lengths. Stents 3 cm in length will be compared to autografts (2-3 cm as standard) with the option for longer lengths (<5 cm). The bridge is an all silk biocompatible tubular silk conduit surrounding silk fibres of bespoke dimensions. These luminal fibres have proven nerve-regenerating properties with the sleeve tube designed to protect the growing nerves and encourage vascularisation.Given that peripheral nerve fibres are the same everywhere in the body we provide a new approach to treating patients for injuries caused by trauma or invasive surgery that would currently face absence of treatment options or suffer the morbidity of autograft repairs.