Devices and methods for nerve regeneration

Inventors

Archibald, Simon J.

Assignees

Integra Lifesciences Corp

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Publication Number

US-12048777-B2

Patent

Publication Date

2024-07-30

Expiration Date


Abstract

The present invention is directed to a nerve regeneration conduit including a resorbable tube having a matrix therein. The matrix is characterized by substantially parallel, axially aligned pores extending the length of the matrix. The matrix is formed by the axial freezing of a slurry having little or no significant radial thermal gradient during the freezing process. The matrix is used to bridge the gap between the severed ends of a nerve and provide a scaffold for nerve regeneration.

Core Innovation

A mold has a plurality of chambers formed therein, where each chamber is insulated from all other chambers, and a collagen conduit having first and second open ends is provided within each chamber and held in a vertical position. A heat sink is placed at a first end of each chamber, and a liquid slurry comprising collagen, chondroitin sulfate, and water is introduced into each collagen conduit. Conductive heat transfer axially freezes the slurry along a length of each collagen conduit so the slurry is progressively frozen from the first open end proximal to the heat sink to the second open end, forming ice crystals that are parallel and axially aligned with each other.

The frozen slurry is lyophilized to remove the ice crystals, thereby forming a matrix having pores that are parallel to and axially aligned with each other. The pores span from a first end of the matrix to a second end of the matrix within the collagen conduit. Each collagen conduit and the matrix contained therein are cross-linked.

Claims Coverage

The claims coverage includes 4 inventive features.

Insulated multi-chamber molding of resorbable collagen conduits

A mold having a plurality of chambers formed therein, where each chamber is insulated from all other chambers; providing a collagen conduit within each chamber, wherein the collagen conduit has first and second open ends and is resorbable; holding each collagen conduit in a vertical position within a corresponding chamber.

Axial heat sinking for progressive freezing of an aligned collagen/chondroitin sulfate slurry

Placing a heat sink at a first end of each chamber; introducing a liquid slurry into each collagen conduit while held vertically in the mold, where the slurry comprises collagen, chondroitin sulfate, and water; conductively transferring heat using the heat sink to axially freeze the liquid slurry along a length of each collagen conduit so the slurry is progressively frozen starting from the first open end proximal to the heat sink to the second open end, forming ice crystals that are parallel and axially aligned with each other.

Lyophilization to form an axially aligned porous matrix spanning the conduit

Lyophilizing the frozen slurry to remove the ice crystals, thereby forming a matrix having pores that are parallel to and axially aligned with each other, where the pores span from a first end of the matrix to a second end of the matrix within the collagen conduit.

Cross-linking of the collagen conduit and matrix

Cross-linking each collagen conduit and the matrix contained therein.

The inventive features include insulated multi-chamber molding, axial heat sinking and progressive freezing of an aligned collagen/chondroitin sulfate slurry, lyophilization to form an axially aligned porous matrix spanning the conduit, and cross-linking of the collagen conduit and matrix.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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