Medical graft device with meshed structure

• US 8,049,059 B2
• Filed: 10/25/2002
• Issued: 11/01/2011
• Est. Priority Date: 10/26/2001
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Inventors: Patel, Umesh H., Bleyer, Mark W.
• Primary Examiner(s): Willse; David H.
• Application Number:
  US10/493,458
• Publication Number:
  US 20050021141A1
• Time in Patent Office: 3,294 Days
• Field of Search: 623/23.74, 623/15.12
• US Class Current: 602/47
• CPC Class Codes: A61F 2/105 Skin implants, e.g. artificial skin
• CPC Class Codes: A61L 15/40 containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts
• CPC Class Codes: A61L 15/42 Use of materials characterised by their function or physical properties liquid bandages A61L26/00
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3666 Epithelial tissues other than skin
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/60 Materials for use in artificial skin
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof

Abstract

A tissue graft product includes at least one collagen layer comprised of submucosa or renal capsule tissue having slits therein to provide a mesh pattern which in turn establishes a graft structure that is highly deformable. The slits and mesh pattern provide for improved characteristics when utilized as a tissue graft and in particular an external wound care. Preferred devices have multiple submucosa, renal capsule or other collagenous extracellular matrix layers, providing a substantial and lasting scaffold for tissue ingrowth during wound treatment.

Claims

1. A medical product, comprising:

a sterile package; and

a sterile tissue graft product contained within said sterile package, said tissue graft product exhibiting a non-tubular, sheet form and being useful for treating an exuding open cutaneous wound, the sterile tissue graft product having a thickness extending between a top outermost surface of the sterile tissue graft product and a bottom outermost surface of the sterile tissue graft product, wherein an extracellular matrix material obtained from a biological tissue source spans the entirety of said thickness and has a plurality of slits therein providing a mesh pattern, said mesh pattern effective to provide an expansion ratio of at least about 1.2;

1 to said extracellular matrix material in a hydrated condition, the extracellular matrix material including submucosa or renal capsule tissue retaining growth factors native to the biological tissue source and having a nucleic acid level of less than 5 micrograms per milligram.

2. A tissue graft product according to claim 1, wherein said extracellular matrix material comprises intestinal submucosa, stomach submucosa, urinary bladder submucosa, or uterine submucosa.

3. A tissue graft product according to claim 2, wherein said extracellular matrix material comprises small intestinal submucosa.

4. A tissue graft product according to claim 1, wherein said extracellular matrix material comprises at least two submucosa layers, said submucosa layers bonded together.

5. The tissue graft product according to claim 4, wherein said submucosa layers are bonded together by a chemical crosslinker.

6. The tissue graft product according to claim 4, wherein said submucosa layers are bonded together in the absence of a chemical crosslinker.

7. The tissue graft product according to claim 6, wherein said submucosa layers are bonded together by dehydration bonding.

8. The tissue graft product according to claim 4, wherein said submucosa layers are bonded to form a substantially unitary collagen layer.

9. The tissue graft product according to claim 8, wherein said submucosa layers are bonded over substantially the entire area in which they contact one another.

10. A tissue graft product according to claim 4, wherein said submucosa layers retain basic fibroblast growth factor (FGF-2) native to the biological tissue source.

11. A tissue graft product according to claim 4, wherein said mesh pattern is effective to provide an expansion ratio of at least about 2:

1 to said extracellular matrix material in a hydrated condition.

12. A tissue graft product according to claim 11, wherein said submucosa layers each have a thickness of about 50 microns to about 200 microns in a hydrated condition.

13. A tissue graft product according to claim 12, wherein said submucosa or renal capsule tissue additionally retains heparin sulfate, hyaluronic acid and fibronectin from the biological tissue source.

14. A tissue graft product according to claim 1, wherein said expansion ratio is at least about 2:

1.

15. A tissue graft product according to claim 1, wherein said expansion ratio is at least about 3:

1.

16. A tissue graft product according to claim 1, wherein said submucosa or renal capsule tissue additionally retains heparin sulfate, hyaluronic acid and fibronectin from the biological tissue source.

17. The tissue graft product of claim 1, wherein said extracellular matrix material comprises an extracellular matrix layer harvested from the biological tissue source and not subjected to a chemical crosslinker.

18. The tissue graft product of claim 1, wherein said submucosa or renal capsule tissue retains transforming growth factor beta (TGF-beta) native to the biological tissue source.

19. A method for preparing a sterile tissue graft product having a thickness extending between a top outermost surface of the tissue graft product and a bottom outermost surface of the tissue graft product, the method comprising:

providing a sterile package;

providing a sterile tissue graft product contained within said sterile package and exhibiting a non-tubular, sheet form, said tissue graft product comprising an extracellular matrix material that is obtained from a biological tissue source and that includes submucosa or renal capsule tissue retaining growth factors native to the biological tissue source and having a nucleic acid level of less than 5 micrograms per milligram; and

producing in said extracellular matrix material a plurality of slits, said slits providing a mesh pattern, said mesh pattern effective to provide an expansion ratio of at least about 1.2;

1 to said extracellular matrix material in a hydrated condition, wherein said extracellular matrix material spans the entirety of said thickness.

20. A method according to claim 19, wherein said extracellular matrix material includes at least two submucosa layers, said submucosa layers bonded to one another.

21. A method according to claim 20, wherein said submucosa layers are dehydrothermally bonded to one another.

22. A method according to claim 20, wherein said submucosa layers are bonded to one another with a chemical crosslinker.

23. A method according to claim 20, wherein said mesh pattern is effective to provide an expansion ratio of at least about 2:

1 to said extracellular matrix material in a hydrated condition.

24. The method claim 19, wherein said submucosa or renal capsule tissue additionally retains heparin sulfate, hyaluronic acid and fibronectin from the biological tissue source.

25. A medical product, comprising:

a sterile package; and

a sterile tissue graft construct contained within said sterile package, said tissue graft construct exhibiting a non-tubular, sheet form and having a thickness extending between a top outermost surface of the sterile tissue graft product and a bottom outermost surface of the sterile tissue graft construct, the tissue graft construct comprising;

at least two extracellular matrix material layers obtained from a biological tissue source and bonded to one another to provide a multi-layer construct, the at least two extracellular matrix material layers having a nucleic acid level of less than 5 micrograms per milligram and retaining growth factors native to the biological tissue source;

said at least two extracellular matrix material layers spanning the entirety of said thickness and having a plurality of slits therein providing a mesh pattern, said mesh pattern effective to provide an expansion ratio of at least about 1.2;

1 to said extracellular matrix material in a hydrated condition, the extracellular matrix material including submucosa or renal capsule tissue.

26. A tissue graft construct according to claim 25, wherein said at least two extracellular matrix material layers comprise at least two submucosa layers, said submucosa layers bonded to one another.

27. A tissue graft product according to claim 26, wherein said submucosa is intestinal submucosa, stomach submucosa, urinary bladder submucosa, or uterine submucosa.

28. A tissue graft product according to claim 27, wherein said submucosa is small intestinal submucosa.

29. A tissue graft product according to claim 25, wherein said mesh pattern is effective to provide an expansion ratio of at least about 2:

1 to said at least two extracellular matrix material layers in a hydrated condition.

30. The tissue graft construct of claim 25, wherein said extracellular matrix layers are bonded together in the absence of a chemical crosslinker.

31. The tissue graft construct of claim 30, wherein said extracellular matrix layers are bonded together by dehydration.

32. A medical product, comprising:

a sterile package; and

a dried, sterile tissue graft product contained within said sterile package, said dried, sterile tissue graft product exhibiting a non-tubular, sheet form and having a thickness extending between a top outermost surface of the dried, sterile tissue graft product and a bottom outermost surface of the dried, sterile tissue graft product, wherein an extracellular matrix material obtained from a biological tissue source spans the entirety of said thickness and has a plurality of slits therein providing a mesh pattern, said mesh pattern effective to provide an expansion ratio of at least about 1.2;

1 to said extracellular matrix material when the extracellular matrix material is in a hydrated condition, the extracellular matrix material including submucosa or renal capsule tissue retaining growth factors native to the biological tissue source and having a nucleic acid level of less than 5 micrograms per milligram.

33. The medical product of claim 32, wherein said submucosa or renal capsule tissue additionally retains heparin sulfate, hyaluronic acid and fibronectin from the biological tissue source.

34. A medical product, comprising:

a sterile package; and

a sterile tissue graft product contained within said sterile package, said tissue graft product exhibiting a non-tubular, sheet form and being useful for treatment of an exuding, open cutaneous wound, the sterile tissue graft product having a thickness extending between a top outermost surface of the sterile tissue graft product and a bottom outermost surface of the sterile tissue graft product, wherein an extracellular matrix material obtained from a biological tissue source spans the entirety of said thickness and has a plurality of slits therein providing a mesh pattern, the extracellular matrix material including submucosa or renal capsule tissue retaining growth factors native to the biological tissue source and having a nucleic acid level of less than 5 micrograms per milligram, said slits sufficient in number and spacing to allow drainage when applied to the exuding open cutaneous wound so as to maintain contact between tissue of the wound and the tissue graft product, wherein said mesh pattern is effective to provide an expansion ratio of at least about 1.2;

1 to said extracellular matrix material in a hydrated condition.

35. The tissue graft product of claim 34, wherein said submucosa or renal capsule tissue additionally retains heparin sulfate, hyaluronic acid and fibronectin from the biological tissue source.