Devices and methods for nerve regeneration
Inventors
Archibald, Simon J. • O'Brien, Fergal • Matsiko, Amos
Assignees
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Publication Number
US-11179157-B2
Publication Date
2021-11-23
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
The invention relates to a nerve guide conduit with an internal matrix formed inside a hollow outer collagen tube. The internal matrix is produced by filling the collagen tube with a slurry comprising collagen, chondroitin sulfate, fibronectin, laminin-1, and laminin-2, where the chondroitin sulfate, fibronectin, laminin-1, and laminin-2 have a dry weight basis in a ratio of about 1:1:1:1.
The freezing is carried out with the slurry having no detectable radial thermal gradient, and the frozen slurry within the collagen tube is freeze dried to remove the parallel axially aligned crystals. This forms an internal matrix having parallel axially aligned internal matrix pores that span one end of the matrix to the other.
The disclosed compositions and pore architecture are tied to nerve regeneration, including the intended promotion of Schwann cell basal lamina-mimicking microenvironment and growth across severed peripheral nerve gaps. The invention also supports embodiments in which the conduit is formed directly with the internal matrix or includes filling a conduit housing plus connectors such as cuffs or collagen wrap/sheet to provide the nerve guide conduit.
Claims Coverage
The independent claim is a method for making a nerve guide conduit having a hollow outer collagen tube and a specific internal matrix formed by axial freezing without a detectable radial thermal gradient and subsequent freeze drying to generate parallel axially aligned internal matrix pores. The independent claim concentrates the inventive features into three main areas: tube-and-slurry composition, axial freezing with no detectable radial thermal gradient, and freeze drying to form end-to-end aligned pores.
Hollow outer collagen tube with slurry composition for internal matrix
Providing an outer collagen tube wherein the tube is hollow; filling the collagen tube with a slurry comprising collagen, chondroitin sulfate, fibronectin, laminin-1, and laminin-2 with a dry weight basis ratio of about 1:1:1:1.
Axial freezing with no detectable radial thermal gradient to form parallel axially aligned crystals
Freezing the slurry along an axial direction of the slurry, with the slurry having no detectable radial thermal gradient, to form a frozen slurry having parallel axially aligned crystals.
Freeze drying to remove aligned crystals and form end-to-end parallel axially aligned internal matrix pores
Freeze drying the collagen tube and the frozen slurry to remove the parallel axially aligned crystals and form the internal matrix having parallel axially aligned internal matrix pores that span one end of the matrix to the other.
Overall, the claim coverage centers on producing a nerve guide conduit by using a hollow outer collagen tube filled with a specified collagen/chondroitin sulfate/fibronectin/laminin slurry, freezing axially with no detectable radial thermal gradient to generate parallel axially aligned crystals, and freeze drying to create parallel axially aligned internal matrix pores spanning the matrix end-to-end.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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