Method for producing a collagen membrane and uses thereof
Inventors
Assignees
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Publication Number
US-10888638-B2
Publication Date
2021-01-12
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 invention provides a method of producing a collagen-containing membrane from isolated collagen-containing tissue comprising collagen bundles. The method sequentially incubates the tissue in an ethanol solution, then incubates the tissue in a solution containing an inorganic salt and an anionic surfactant to denature non-collagenous proteins contained therein. After that, the tissue is incubated in HCl until the collagen in the tissue is denatured.
After denaturing collagen with HCl, the method manipulates the collagen-containing tissue using simultaneous mechanical stimulation for sufficient time to enable the collagen bundles to align. The mechanical stimulation comprises applying tension cyclically to the collagen-containing tissue. The manipulated tissue is then incubated in a solution comprising HCl until the collagen-containing membrane is produced.
The described process is aimed at producing a collagen-containing membrane with aligned collagen bundles, formed from denatured collagen under cyclic tension during HCl incubation. Dependent refinements specify particular inorganic salts and anionic surfactants selected from stated groups, and further define intermediate processing steps such as additional contact and washing/contact actions, including glycerol contact.
Claims Coverage
This partial document provides one independent claim (clm-00001). The claim covers a sequential chemical denaturation workflow followed by cyclic tension-based manipulation during additional HCl incubation to produce a collagen-containing membrane, totaling four main inventive features across the independent claim.
Sequential denaturation using ethanol and denaturing inorganic salt/anionic surfactant solution
A method producing a collagen-containing membrane by incubating isolated collagen-containing tissue in an ethanol solution, and then incubating the tissue in a solution comprising an inorganic salt selected from trimethylammonium chloride, tetramethylammonium chloride, sodium chloride, lithium chloride, perchlorate and trifluoromethanesulfonate, together with an anionic surfactant selected from alkyl sulfates, alkyl ether sulfates, alkyl sulfonates, and alkyl aryl sulfonates, to denature non-collagenous proteins contained therein.
Denaturation of collagen in HCl
Incubating the collagen-containing tissue produced after the inorganic salt/anionic surfactant step in a solution comprising HCl until the collagen in said tissue is denatured.
Cyclic tension manipulation to align collagen bundles
Manipulating the collagen-containing tissue produced in the HCl collagen-denaturation step using simultaneous mechanical stimulation for sufficient time so that the collagen bundles in the collagen-containing tissue align, wherein the mechanical stimulation comprises applying tension cyclically to the collagen-containing tissue.
Additional HCl incubation to produce collagen-containing membrane
After cyclic-tension manipulation, incubating the tissue in a solution comprising HCl until the collagen-containing membrane is produced.
The independent claim is directed to producing a collagen-containing membrane via sequential ethanol treatment, inorganic salt plus anionic surfactant denaturation of non-collagenous proteins, HCl denaturation of collagen, and cyclic tension manipulation to align collagen bundles, followed by further HCl incubation until the membrane is produced.
Stated Advantages
Reduced inflammation/fibrosis.
Reduced antigenicity.
Faster perforation closure in tympanic membrane repair.
Improved histological organization.
Earlier auditory brainstem response hearing recovery.
Documented Applications
Repair of tympanic membrane perforation (myringoplasty), including use described as a “TYMPACOL™ membrane (ACS)” compared with BIO-GIDE™, paper patch, and GELFOAM® in a rat model.
Treatment context described in preclinical outcomes for rat tympanic membrane repair, including histological and auditory brainstem response (ABR) hearing recovery measurements.
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