Flat self-curling permeable sheet membrane

Inventors

Li, Shu-TungLee, Natsuyo ShishidoYuen, Debbie

Assignees

Collagen Matrix Inc

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Publication Number

US-9308219-B2

Patent

Publication Date

2016-04-12

Expiration Date


Abstract

A flat self-curling permeable sheet membrane containing a matrix formed of crosslinked biopolymeric fibers. The matrix self-curls into a predetermined shape upon absorption of an aqueous fluid and is permeable to molecules having molecular weights not greater than 1×106 daltons. Also disclosed is a method of preparing such a flat self-curling permeable membrane.

Core Innovation

The invention provides a dry flat self-curling permeable sheet membrane comprising a flat layer of crosslinked collagen fibers. The sheet membrane is free of chitosan and glycosaminoglycan, and the flat layer self-curls into a predetermined shape when absorbing an aqueous fluid. The predetermined shape is a v, a tube, an arch, or a channel, and the membrane is permeable to molecules having molecular weights not greater than 1×10^6 daltons.

The membrane is characterized by physical and mechanical performance, including target thickness, density, hydrothermal shrinkage temperature, strength properties, self-curling time, in vivo resorption time, suture pullout strength, tensile strength, and compression resistance. The document correlates hydrothermal shrinkage temperature with in vivo resorption time and distinguishes dry versus hydrated measurement states.

A preparation approach is disclosed that forms a dry flat self-curling permeable sheet membrane by reconstituting biopolymeric fibers, forming a permeable sheet membrane containing a layer of the reconstituted biopolymeric fibers, folding the sheet in a hydrated state into a predetermined shape, and crosslinking while the folded sheet membrane is kept in that predetermined shape. The folded sheet membrane is then flattened in the hydrated state followed by drying so that the flat membrane self-curls into the predetermined shape upon absorption of an aqueous fluid.

Claims Coverage

The document provides two independent claim sets and an additional independent product-preparation claim. Across these independent claims, the coverage centers on a dry flat self-curling permeable membrane free of chitosan and glycosaminoglycan with a molecular-weight permeability cutoff, and on a preparation method that preserves a predetermined V/tube/arch/channel shape during crosslinking in a hydrated folded state.

Dry flat self-curling permeable collagen-fiber membrane with specified permeability

A dry flat self-curling permeable sheet membrane comprising a flat layer of crosslinked collagen fibers, free of chitosan and glycosaminoglycan, wherein the flat layer self-curls into a predetermined shape (v, tube, arch, or channel) upon absorption of an aqueous fluid, and is permeable to molecules having molecular weights not greater than 1×10^6 daltons.

Preparing a dry flat self-curling permeable sheet membrane by hydrated folding, shaped crosslinking, and drying

A method for preparing a dry flat self-curling permeable sheet membrane comprising reconstituting biopolymeric fibers dispersed in a solution; forming a permeable sheet membrane containing a layer of the reconstituted biopolymeric fibers; folding the sheet membrane in a hydrated state into a predetermined shape; crosslinking the biopolymeric fibers while the folded sheet membrane is kept in the predetermined shape; and flattening the folded sheet membrane in a hydrated state followed by drying to form a flat membrane that self-curls into the predetermined shape upon absorption of an aqueous fluid, wherein the predetermined shape is a v, a tube, an arch, or a channel; the sheet membrane is free of chitosan and glycosaminoglycan; and the biopolymeric fibers are collagen fibers.

Preparing a dry flat self-curling permeable sheet membrane by hydrated folding, shaped crosslinking, and drying (with collagen fibers)

A dry flat self-curling permeable sheet membrane prepared by reconstituting biopolymeric fibers dispersed in a solution; forming a permeable sheet membrane containing a layer of the reconstituted biopolymeric fibers; folding the sheet membrane in a hydrated state into a predetermined shape; crosslinking the biopolymeric fibers while the folded sheet membrane is kept in the predetermined shape; and flattening the folded sheet membrane in a hydrated state followed by drying to form a flat membrane that self-curls into the predetermined shape upon absorption of an aqueous fluid, wherein the predetermined shape is a v, a tube, an arch, or a channel; the sheet membrane is free of chitosan and glycosaminoglycan; and the biopolymeric fibers are collagen fibers.

Overall, the independent claims cover a dry flat self-curling permeable membrane made of crosslinked collagen fibers free of chitosan and glycosaminoglycan with a specified molecular-weight permeability cutoff, and they also cover preparation methods using reconstituted biopolymeric fibers, formation of a permeable sheet layer, hydrated folding into a predetermined V/tube/arch/channel shape, crosslinking while held in the predetermined shape, and drying after hydrated flattening so that the membrane self-curls upon aqueous-fluid absorption.

Stated Advantages

A dry flat membrane self-curls into predetermined shapes (v, tube, arch, or channel) upon absorption of aqueous fluid.

The membrane is permeable to molecules having molecular weights not greater than 1×10^6 daltons.

The membrane is free of chitosan and glycosaminoglycan.

The document states defined mechanical and biological performance parameters, including suture pullout strength, tensile strength, compression resistance, self-curling time, and in vivo resorption time.

Documented Applications

Wound healing applications including tendon/ligament repair and peripheral nerve repair.

Vascular anastomoses.

Dental ridge augmentation and dental implantation-related coverage.

Orthopedic/spine surgery and fusion.

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