Medical constructs including tubes and collagen fibers

Patent metadata

Field	Value
Publication number	US-9801978-B2
Application number	US-201514875202-A
Country	US
Kind code	B2
Filing date	Oct 5, 2015
Priority date	Oct 9, 2008
Publication date	Oct 31, 2017
Grant date	Oct 31, 2017

Abstract

Medical constructs with collagen fibers and gelatin and related collagen fibers. The collagen fibers can be derived from extruded soluble dermal collagen and can include a gelatin film attached to the at least one collagen fiber. The gelatin film can include one or more minerals and has a gelatin concentration of between about 0.1% to about 40% weight per volume.

First claim

That which is claimed:

1. A medical device, comprising:
a tube with a wall surrounding an axially extending cavity, the wall having at least one wound collagen fiber derived from extruded soluble dermal collagen and a gelatin film attached to the at least one collagen fiber, the gelatin film comprising one or more minerals and having a gelatin concentration of between about 0.1% to about 40% weight per volume, wherein the at least one wound collagen fiber has a pattern with a number of revolutions about the tube cavity with overlying intersecting segments over at least a major portion of a length of the tube.

2. A medical device according to claim 1 , wherein the one or more minerals is selected from the following minerals: calcium phosphate, calcium hydrogen phosphate, calcium dihydrogen phosphate, monotite, brushite, calcium pyrophosphate, tricalcium phosphate, tetracalcium phosphate, octacalcium phosphate, amorphous calcium phosphate, hydroxyapatite, carbonateapatite, calcite, and/or calcium sulfate.

3. A medical device according to claim 1 , wherein the one or more minerals comprises hydroxyapatite.

4. A medical device according to claim 1 , wherein the gelatin film has a mineral concentration of between about 0.1% to about 30% weight per volume.

5. A medical device according to claim 1 , wherein the gelatin film and collagen fiber are cross-linked with a cross-linking agent selected from the group consisting of: NDGA, carbodiimide, glutaraldehyde, formaldehyde, tannic acid, isocyanates, and epoxy resins.

6. A medical device according to claim 1 , wherein the gelatin film and collagen fiber are cross-linked with NDGA.

7. A medical device according to claim 1 , wherein the medical device is an allo-graft or auto-graft for a tendon or ligament implant or a nerve guide with reversible elasticity.

8. A medical device according to claim 1 , wherein the at least one wound collagen fiber is a single collagen fiber arranged in multiple stacked wound layers, the single fiber having a continuous length with a diameter when dry of between about 0.05 mm (average) to about 0.2 mm (average).

9. A medical device according to claim 1 , further comprising an inner layer of a collagen film attached to the at least one collagen fiber defining an inner surface of the tube wall and an outer layer of a collagen film attached to the at least one wound collagen fiber defining an outer surface of the tube wall.

10. A medical device according to claim 1 , wherein the tube is frustoconical.

11. A medical device according to claim 1 , wherein the tube has a rough inner and/or outer surface.

12. At least one elongated collagen fiber, wherein the at least one collagen fiber has a length of between about 1 m to about 100 m and is at least partially coated with a gelatin film comprising one or more minerals and having a gelatin concentration of between about 0.1% to about 40% weight per volume.

13. The at least one elongated collagen fiber of claim 12 , wherein the one or more minerals is selected from the following minerals: calcium phosphate, calcium hydrogen phosphate, calcium dihydrogen phosphate, monotite, brushite, calcium pyrophosphate, tricalcium phosphate, tetracalcium phosphate, octacalcium phosphate, amorphous calcium phosphate, hydroxyapatite, carbonateapatite, calcite, and/or calcium sulfate.

14. The at least one elongated collagen fiber of claim 12 , wherein the one or more minerals comprises at least one of tricalcium phosphate, hydroxyapatite, and/or calcium sulfate.

15. The at least one elongated collagen fiber of claim 12 , wherein the one or more minerals comprises hydroxyapatite.

16. The at least one elongated collagen fiber of claim 12 , wherein the gelatin film has a mineral concentration of between about 0.1% to about 30% weight per volume.

17. The at least one elongated collagen fiber of claim 12 , wherein the at least one elongated collagen fiber is a plurality of collagen fibers in substantially parallel arrays or are braided, woven, and/or twisted together.

18. The at least one elongated collagen fiber of claim 12 , wherein the at least one fiber is cross-linked with a cross-linking agent selected from the group consisting of: NDGA, carbodiimide, glutaraldehyde, formaldehyde, tannic acid, isocyanates, and epoxy resins.

19. The at least one elongated collagen fiber of claim 12 , wherein the at least one collagen fiber is an NDGA polymerized collagen fiber.

20. The medical device of claim 1 , wherein the tube further comprises an inner layer of collagen film and an outer layer of collagen film, and wherein at least one of the one or more minerals in the gelatin film is different than one or more minerals in the inner layer of collagen film and/or the outer layer of collagen film.

21. An implantable medical device comprising:
a tube with a wall surrounding an axially extending cavity, the wall having at least one collagen fiber with a continuous length arranged in a pattern having a number of revolutions about the tube cavity with overlying intersecting segments over at least a major portion of a length of the tube;
a gelatin film attached to the at least one collagen fiber, the gelatin film comprising one or more minerals and having a gelatin concentration of between about 0.1% to about 40% weight per volume;
at least one layer of collagen film attached to the at least one collagen fiber residing over the gelatin film; and
at least one layer of collagen film attached to the at least one collagen fiber residing under the gelatin film.

22. The medical device of claim 21 , wherein the one or more minerals is selected from the following minerals: calcium phosphate, calcium hydrogen phosphate, calcium dihydrogen phosphate, monotite, brushite, calcium pyrophosphate, tricalcium phosphate, tetracalcium phosphate, octacalcium phosphate, amorphous calcium phosphate, hydroxyapatite, carbonateapatite, calcite, and/or calcium sulfate.

23. The medical device of claim 21 , wherein the gelatin film and collagen fiber are cross-linked with a cross-linking agent selected from the group consisting of: NDGA, carbodiimide, glutaraldehyde, formaldehyde, tannic acid, isocyanates, and epoxy resins.

24. The medical device of claim 21 , wherein the tube has a rough inner and/or outer surface.

25. The medical device of claim 21 , wherein at least one mineral of the one or more minerals in the gelatin film is different than one or more minerals in the at least one layer of collagen film residing over and/or under the gelatin film.

26. The at least one elongated collagen fiber of claim 12 , wherein the at least one collagen fiber is derived from extruded soluble dermal collagen.

27. The medical device of claim 21 , wherein the at least one collagen fiber is derived from extruded soluble dermal collagen.

28. A medical device according to claim 1 , wherein the at least one wound collagen fiber has a length of between about 1 m to about 100 m.

29. The medical device of claim 21 , wherein the at least one collagen fiber has a length of between about 1 m to about 100 m.

Assignees

• Mimedx Group Inc

Inventors

• Paulos Leon
• Li Mengyan
• Hernandez Daniel
• Koob Thomas

Classifications

• B32B37/142

  Laminating of sheets, panels or inserts, e.g. stiffeners, by wrapping in at least one outer layer, or inserting into a preformed pocket · CPC title

• A61L27/50

  Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} · CPC title

• A61L27/507

  for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062) · CPC title

• B29C53/66

  with axially movable winding feed member {, e.g. lathe type winding} · CPC title

• B32B37/20

  involving the assembly of continuous webs only · CPC title