Bridging peripheral nerve gaps with conduits for enhanced nerve regeneration
Inventors
Woods, Alexander • PLOWRIGHT, Robyn • VOLLRATH, Friedrich
Assignees
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Publication Number
US-12471923-B2
Publication Date
2025-11-18
Expiration Date
Abstract
Disclosed herein are compositions comprising containers and silk elements. Disclosed herein are methods of regenerating an at least partially severed nerve cell. Disclosed herein are compositions for regenerating an at least partially severed nerve cell.
Core Innovation
The invention relates to implantable silk-based nerve-regeneration devices and methods for treating a nerve injury. The methods regenerate an axon and reconnect two severed portions of a nerve across a nerve gap by implanting silk elements into the gap so the axon is at least partially in contact with the plurality of silk elements. The approach is described in the context of bridging severed nerve ends across long gaps.
The invention provides at least two bundles comprising a plurality of silk elements, with the bundles spanning at least a portion of a length of a sheath. An individual silk element in each bundle is coated in a first hydrophilic coating, and at least two of the bundles are coated and wrapped in a second hydrophilic coating that at least partly maintains continual spacing of the bundles along their length.
In another aspect, the invention uses a first silk element substantially within a sheath that is at least in part flexible and created by crosslinking of the sheath. The inner surface of the sheath is smooth, and the flexible sheath is configured to bend without breaking or kinking while maintaining patency of the sheath and maintaining patency of a lumen. The document also describes implantable container or tube or sheath configurations with openings or porosity concepts to enable in vivo axon regrowth across severed nerve gaps.
Claims Coverage
Two independent claims are present. The first covers implanting at least two silk-element bundles with hydrophilic coatings and continual spacing into a nerve gap to regenerate axons and reconnect severed nerve portions. The second covers implanting a silk element inside a crosslinked flexible smooth-inner-surface sheath with bending and patency characteristics to regenerate and reconnect across the gap.
Axon regeneration along spaced hydrophilic-coated silk-element bundles across a nerve gap
A method of treating a nerve injury comprising implanting at least two bundles comprising a plurality of silk elements into a subject in a gap between two severed portions of a nerve and regenerating an axon of said nerve along said plurality of silk elements to reconnect said two severed portions of said nerve across said gap while said axon is at least partially in contact with said plurality of silk elements, wherein the bundles span at least a portion of a length of a sheath; an individual silk element in each bundle is coated in a first hydrophilic coating; at least two of the bundles are coated wrapped in a second hydrophilic coating; and the bundles are at least partially continually spaced from one another along their length with the second hydrophilic coating at least partly maintaining continual spacing.
Crosslinked flexible smooth-inner-surface sheath enabling bending without breakage or loss of lumen patency
A method of treating a nerve injury comprising implanting a first silk element into a subject in a gap between two severed portions of a nerve and regenerating an axon of said nerve along said first silk element to reconnect said two severed portions of said nerve across said gap, wherein the first silk element is substantially within a sheath; the sheath is at least in part flexible created by crosslinking; an inner surface of the sheath is smooth; the at least in part flexible comprises an ability to bend the sheath into less than about a 90° angle between a proximal end and a distal end of the sheath; bending comprises bending without breaking, without kinking, while maintaining patency of the sheath and maintaining patency of a lumen; and the sheath comprises a silk material.
Overall, the claim coverage centers on reconnecting severed nerve portions across a gap by regenerating axons along implanted silk elements, with inventive emphasis on hydrophilic coatings that support continual spacing of silk-element bundles and a crosslinked flexible sheath with a smooth inner surface and bending and patency characteristics.
Stated Advantages
The approach contrasts limitations of prior nerve repair options such as autografts and other conduits.
The invention states advantages including reduced fibrosis/infiltration.
The invention states avoiding additional removal surgeries.
Documented Applications
The disclosed methods and devices are documented in animal-model contexts, including a dog trial with matrix-embedded conduits.
The disclosed methods and devices are documented in animal-model contexts, including sheep tibial nerve reconstructions with corrugated conduits.
The disclosed methods and devices are documented in animal-model contexts, including rat sciatic nerve defect models comparing autograft versus hollow silk conduit versus silk-in-silk conduit filled with longitudinal Nephila edulis dragline silk.
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