Background:

The spiral nerve guidance conduit is a biodegradable Polycaprolactone (PCL) spiral tube designed for bridging an injured peripheral nerve gap without tension and providing a large surface area for axon regrowth. In contract to our conduit, the traditional conduits support regeneration only along the tubular walls of the scaffolds which do not possess enough surface area to house a large number of cells needed for nerve regeneration.

Summary:

The spiral nerve guidance conduit is a patent pending technology that involves innovative manufacturing process that combines nanofiber technology and 3D micro-environment to best mimic the native nerve. It combines biodegradable polymeric material, PCL, a commonly used implantable material that is already FDA approved for multiple uses.

The technology is based on a novel integrated spiral structure with aligned nanofibers to overcome the defects of lacking durable mechanical strength, not integrated multi-channels, limited passage of small molecules (i.e. water, ions, nutrients) and inter-cell communication, unstable aligned fibrous layers, and low surface area. Chambers at the proximal and distal ends of conduit preserve additional spaces for suturing the nerve stump in order to provide the tensionless repair at the suture line. Yet, outer fibrous permeable tubular shell allows nutrients to diffuse and resists the scar tissue infiltration while the regeneration process is taken.

Applications:

- Any injured peripheral nerve

Benefits:

- No donor nerve harvest avoids a second surgical procedure

- Function at the potential donor site is preserved

- Multiple small grafts are needed in case of a long nerve gap

- There could be a problem of size mismatch between the donor nerve graft and injured nerve

- Complete functional recovery is seldom obtained even with auto grafts

Stage of development:

Provisional Filed

Keywords:

Peripheral Nerve Injury, Nerve Guidance Conduit, Spiral Guidance Channel, Aligned Nanofibers

Full Patent: Fabrication Of An Implantable Nerve Conduit Having A Polymer Fiber Spiral Guidance Channel