Method for treating a tissue defect with a collagen-containing membrane
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Publication Number
US-12226548-B2
Publication Date
2025-02-18
Expiration Date
Abstract
The present invention relates to a method of producing a collagen membrane that has particular mechanical properties. In particular, the present invention relates to a method A of producing a collagen membrane comprising the steps of (i) isolating a collagen-containing tissue and incubating same in an ethanol solution; (ii) incubating the collagen-containing tissue from step (i) in a first solution comprising an inorganic salt and an anionic surfactant in order to denature non-collagenous proteins contained therein; (iii) incubating the collagen-containing tissue produced in step (ii) in a second solution comprising an inorganic acid until the collagen in said material is denatured; and (iv) incubating the collagen-containing tissue produced in step (iii) in a third solution comprising an inorganic acid with simultaneous mechanical stimulation for sufficient time to enable the collagen bundles in said collagen-containing tissue to align; wherein the mechanical stimulation comprises applying tension cyclically to the collagen-containing tissue.
Core Innovation
The document describes a collagen-membrane manufacturing method that uses sequential incubation steps including ethanol incubation, inorganic salt plus anionic surfactant denaturation, and inorganic acid denaturation with HCl. It further includes an alignment step in which collagen bundles are aligned during acid incubation while a simultaneous cyclic tension is applied. The resulting collagen-containing membrane is described as having a knitted structure and distinct first and second surfaces.
The collagen-containing membrane is described as comprising greater than 80% (w/w) type I collagen fibres or bundles in a knitted structure, with a modulus greater than 300 MPa and an extension at maximum load of less than 85%. The membrane has a first surface that is a smooth surface with compact collagen bundles and a second surface that is a rough, porous surface of loose collagen fibres. Embodiments are described as non-cross-linked and as non-glutaraldehyde.
The document further describes treating tissue defects by inserting the collagen-containing membrane into the tissue defect, with particular emphasis on tympanic membrane perforations. It reports preclinical characterization including SEM morphology showing distinct smooth and porous surfaces, and comparative mechanical performance versus BIO-GIDE™ and other reference membranes. In a rat tympanic membrane repair model, it reports faster perforation closure, improved histology and collagen organization, and faster auditory brainstem response hearing recovery compared with paper patch, GELFOAM®, and spontaneous healing, along with ease of handling and improved visualization due to membrane transparency.
Claims Coverage
The provided independent claim defines a treating method based on inserting a collagen-containing membrane with specific collagen composition, mechanical properties, and distinct first and second surfaces. The dependent claims further narrow the collagen type I content thresholds and specify allowable collagen sources (sheep/cow/pig/human, human only) or autologous collagen.
Treatment of a mammalian tissue defect by inserting a defined knitted type I collagen membrane
A method of treating a tissue defect in a mammalian animal subject comprising inserting a collagen-containing membrane into the tissue defect, wherein the membrane has greater than 80% (w/w) type I collagen fibres or bundles in a knitted structure, a modulus greater than 300 MPa, an extension at maximum load less than 85%, and distinct first and second surfaces with the first surface smooth/compact and the second surface rough/porous/loose.
Defined collagen content exceeding 85% type I collagen
The method further comprises that the collagen-containing membrane includes more than 85% (w/w) type I collagen.
Defined collagen content exceeding 90% type I collagen
The method further comprises that the collagen-containing membrane includes more than 90% by weight type I collagen.
Collagen component sourced from sheep, cow, pig, or human
The method further includes a collagen-containing membrane made from collagen bundles and/or collagen fibres originating from a sheep, cow, pig, or human.
Collagen component sourced from human
The method further includes that the collagen-containing membrane includes collagen bundles and/or collagen fibres originating from a human.
Autologous collagen component
The method further includes that the collagen-containing membrane includes collagen bundles and/or collagen fibres and that these collagen components are autologous.
Overall, the claims coverage centers on a treating method that inserts a mechanically constrained knitted collagen-containing membrane defined by high type I collagen content (>80% w/w in the independent claim), modulus (>300 MPa), limited extension (<85% at maximum load), and distinct first (smooth/compact) and second (rough/porous) surfaces, with dependent claims tightening the type I content thresholds and restricting collagen origin and/or autologous status.
Stated Advantages
Faster perforation closure in the rat tympanic membrane repair model.
Improved histology and collagen organization.
Faster auditory brainstem response hearing recovery compared with paper patch, GELFOAM®, and spontaneous healing.
Ease of handling.
Improved visualization due to membrane transparency.
Documented Applications
Repairing tympanic membrane perforations by implanting/inserting a collagen-containing membrane into a tissue defect (rat tympanic membrane repair model).
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