High-strength collagen compositions and methods of use
The invention relates to engineered collagen scaffolds with a thickness of from about 0.005 mm to about 3 mm, and with a high strength (e.g., a high elastic modulus of from about 0.5 MPa to about 200 MPa). The engineered collagen scaffolds can be non-collapsible and/or non-expandable. This disclosure also relates to methods of use of these collagen scaffolds.
1 . A non-collapsible and/or non-expandable collagen scaffold comprising oligomeric collagen formed by compressing a polymerized oligomeric collagen scaffold into a defined shape having a thickness of about 0.005 mm to about 3 mm, a collagen density of about 50 to about 1000 mg/cm 3 and an elastic modulus of about 0.5 MPa to about 200 MPa, wherein said compressed polymerized oligomeric collagen scaffold will not swell or collapse when lyophilized or rehydrated.
2 . The non-collapsible and/or non-expandable collagen scaffold of claim 1 , wherein the non-collapsible and/or non-expandable collagen scaffold has a suture retention load of about 0.1 N to about 4 N.
3 . The non-collapsible and/or non-expandable collagen scaffold of claim 1 , wherein the non-collapsible and/or non-expandable collagen scaffold has an ultimate tensile strength of about 1 MPa to about 25 MPa.
4 . The non-collapsible and/or non-expandable collagen scaffold of claim 1 , wherein the polymerized oligomeric collagen scaffold is compressed into a defined shape selected from the group consisting of a sphere, a tube and a sheet.
5 . The non-collapsible and/or non-expandable collagen scaffold of claim 1 , wherein the compression is confined compression.
6 . A method of treating a patient to replace, restore, or regenerate a damaged or a dysfunctional tissue, the method comprising implanting into the patient a medical graft comprising the non-collapsible and/or non-expandable collagen scaffold of claim 1 .
7 . The method of claim 6 , wherein the medical graft is for the regeneration, restoration, or replacement of damaged or dysfunctional pericardium.
8 . The method of claim 6 , wherein the medical graft is for the regeneration, restoration, or replacement of damaged or dysfunctional heart valve tissue.
9 . The method of claim 6 , wherein the medical graft is for the regeneration, restoration, or replacement of damaged or dysfunctional skin.
10 . The method of claim 8 , wherein the heart valve tissue is aortic heart valve tissue or pulmonic valve tissue.
11 . A non-collapsible and/or non-expandable oligomeric collagen scaffold, wherein the non-collapsible and/or non-expandable oligomeric collagen scaffold is formed from Type I oligomeric collagen that has been polymerized in the absence of an added crosslinking agent and compressed into a defined shape having a thickness of about 0.005 mm to about 3 mm, and a collagen density of about 50 to about 1000 mg/cm 3 .
12 . The oligomeric collagen scaffold of claim 11 , having an elastic modulus of about 0.5 MPa to about 200 MPa.
13 . The oligomeric collagen scaffold of claim 11 , wherein the collagen density is about 50 to about 700 mg/cm 3 .
14 . The oligomeric collagen scaffold of claim 11 , formed by heating and subjecting the polymerized oligomeric collagen to a vacuum to compress the polymerized oligomeric collagen into a defined shape having a thickness of from 0.005 mm to 3 mm, and a collagen density of 100 to 700 mg/cm 3 .
15 . The oligomeric collagen scaffold of claim 11 , having a thickness of about 0.1 mm to about 2 mm, and a collagen density of about 50 to about 700 mg/cm 3 .
16 . The oligomeric collagen scaffold of claim 11 , having a thickness of about 0.1 mm to about 1 mm, and a collagen density of about 50 to about 700 mg/cm 3 .
17 . The oligomeric collagen scaffold of claim 11 , further comprising cells.
18 . The oligomeric collagen scaffold of claim 11 , formed by subjecting the polymerized Type I oligomeric collagen scaffold to confined compression, where said defined shape is selected from the group consisting of a sphere, a tube and a sheet, and wherein said compressed polymerized oligomeric collagen scaffold will not swell or collapse when lyophilized or rehydrated.