IP Library Granted Patent US 12,708,696
Granted Patent B2
US 12,708,696 · App. 17/915,719 · Granted Aug 18, 2026

High-strength collagen compositions and methods of use

Inventors: Sherry L. Voytik-Harbin (Zionsville, IN); Theodore J. Puls (Carmel, IN)
Assignee: GENIPHYS, INC.
A61L27/24A61L27/3834A61L27/50A61L2430/20
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Quick Facts
Patent No.
US 12,708,696
App. No.
17/915,719
Filed
Sep 29, 2022
Granted
Aug 18, 2026
Kind
B2
Art Unit
3774
USPC
623/23.72
Abstract

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.

Claims (18)

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.

Continuity (2)
Provisional Application 63002644 · Mar 31, 2020
Related Publication 20230131204A1 · Apr 27, 2023
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