Prosthetic implants including ECM composite material

• US 8,454,678 B2
• Filed: 03/17/2006
• Issued: 06/04/2013
• Est. Priority Date: 03/19/2005
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Inventors: Hiles, Michael
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US11/378,690
• Publication Number:
  US 20060210597A1
• Time in Patent Office: 2,636 Days
• Field of Search: 435/325, 435/373, 435/377, 435/383, 435/395, 435/384
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61L 27/22 Polypeptides or derivatives thereof , e.g. degradation products
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• 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 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3895 using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/044 Collagen
• CPC Class Codes: A61L 31/047 Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
• CPC Class Codes: C08L 89/00 Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00

Abstract

Described are preferred prosthetic valve devices including a first extracellular matrix material having a second extracellular matrix material deposited thereon. The preferred materials are made by culturing cells in contact with an extracellular matrix graft material in a fashion to cause the cells to biosynthesize and deposit extracellular matrix components on the material. The cells are then removed to provide the extracellular matrix composite material. In preferred embodiments, the prosthetic valve devices are configured for use in vascular applications.

Claims

1. A prosthetic valve device for implantation in a bodily passage, comprising:

an artificial valve comprising a frame and at least two leaflets attached thereto, wherein said leaflets include a first leaflet and a second leaflet formed with an extracellular matrix composite material including a first extracellular matrix material having a surface, and a second, biosynthetically-deposited extracellular matrix material including extracellular matrix proteins on said surface, said biosynthetically-deposited extracellular matrix material having been deposited on said first extracellular matrix material by cells cultured on said first extracellular matrix material followed by removal of said cells to provide said extracellular matrix composite material;

wherein said extracellular matrix proteins enhance the function of said first extracellular matrix material in each said leaflet by modifying the thrombogenicity and remodeling of the first extracellular matrix material;

wherein said artificial valve has a length of coaptation in the range of about 5 to 30 mm;

wherein said first leaflet and said second leaflet each include a first outer edge;

wherein the first outer leaflet edges of the first and second leaflets are within about 3 mm of one another as they extend in a longitudinal direction along said frame for a distance of about 5 to about 30 mm; and

wherein the valve device is configured such that at least a portion of said outer leaflet edges extending in a longitudinal direction contact the bodily passage when the valve device is implanted in the bodily passage.

2. The prosthetic valve device of claim 1, wherein said second extracellular matrix material comprises one or more fiber-forming proteins.

3. The prosthetic valve device of claim 2, wherein the one or more fiber-forming proteins include collagen and/or elastin.

4. The prosthetic valve device of claim 1, wherein said second extracellular matrix material comprises one or more adhesive proteins.

5. The prosthetic valve device of claim 4, wherein said adhesive proteins comprise fibronectin and/or laminin.

6. The prosthetic valve device of claim 1, wherein the first extracellular matrix material comprises submucosa.

7. The prosthetic valve device of claim 6, wherein the submucosa is intestinal, urinary bladder or stomach submucosa.

8. The prosthetic valve device of claim 7, wherein the submucosa is small intestinal submucosa.

9. The prosthetic valve device of claim 1, wherein the first extracellular matrix material is from a warm-blooded vertebrate.

10. The prosthetic valve device of claim 1, wherein the second extracellular matrix material is human.

11. The prosthetic valve device of claim 1, wherein the second extracellular matrix material is secreted by one or more of endothelial cells, muscle cells, fibroblast cells, mesothelial cells, pericyte cells, macrophage cells, monocyte cells, plasma cells, mast cells, adipocyte cells, chondrocyte cells, stem cells, or a cell population differentiated from stem cells.

12. The prosthetic valve device of claim 11, wherein the second extracellular matrix material contains matrix components secreted by endothelial cells.

13. The prosthetic valve device of claim 12, wherein the endothelial cells are vascular endothelial cells.

14. The prosthetic valve device of claim 13, wherein said device is configured for implantation in the cardiovascular system of a human.

15. The prosthetic valve device of claim 1, wherein said first outer leaflet edges are fixedly attached to said frame over said distance.

16. The prosthetic valve device of claim 1, wherein said extracellular matrix composite is substantially devoid of cells or cell components.

17. The prosthetic valve device of claim 1, wherein said device is configured for vascular applications.

18. A method for treating a patient, comprising:

providing a prosthetic valve device of claim 1 and implanting said prosthetic valve device into a bodily passage of the patient.

19. The method of claim 18, wherein said prosthetic valve device is configured for use in vascular applications.

20. The method of claim 19, wherein said patient is treated for a vascular disease by implanting said valve device into a vascular passage of the patient.

21. The method of claim 20, wherein said patient is treated for valvular insufficiency.

22. A prosthetic valve device for implantation in a bodily passage, comprising:

an artificial valve comprising a frame and at least two leaflets attached thereto, wherein said leaflets include a first leaflet and a second leaflet formed with a decellularized extracellular matrix composite sheet material including a first extracellular matrix material having a surface, and a second, biosynthetically-deposited extracellular matrix material on said surface, wherein said biosynthetically-deposited extracellular matrix material has been deposited on said surface by culturing cells on the first extracellular matrix to deposit extracellular matrix proteins including fiber-forming proteins interwoven in a hydrated gel composed of a network of glycosaminoglycan chains, followed by removal of the cells to provide said decellularized extracellular matrix composite sheet material;

wherein said extracellular matrix proteins enhance the function of said first extracellular matrix material in each said leaflet by modifying the thrombogenicity and remodeling of the first extracellular matrix material;

wherein said artificial valve has a length of coaptation in the range of about 5 to 30 mm;

wherein said first leaflet and said second leaflet each include a first outer edge fixedly attached to the frame and a second outer edge fixedly attached to the frame, a first face spanning between the first outer edge and the second outer edge, and a second face opposite the first face and spanning between the first outer edge and the second outer edge;

wherein the first outer leaflet edges of the first and second leaflets are within about 3 mm of one another as they extend in a longitudinal direction along said frame for a distance of about 5 to about 30 mm; and

wherein the valve device is configured such that at least a portion of said first outer leaflet edges extending in a longitudinal direction contact the bodily passage when the valve device is implanted in the bodily passage.

23. The prosthetic valve device of claim 22, wherein the fiber-forming proteins include collagen and/or elastin.

24. The prosthetic valve device of claim 22, wherein said second extracellular matrix material comprises fibronectin and/or laminin.

25. The prosthetic valve device of claim 22, wherein the first extracellular matrix material comprises submucosa.

26. The prosthetic valve device of claim 25, wherein the submucosa is intestinal, urinary bladder or stomach submucosa.

27. The prosthetic valve device of claim 26, wherein the submucosa is small intestinal submucosa.

28. The prosthetic valve device of claim 22, wherein the first extracellular matrix material is from a warm-blooded vertebrate.

29. The prosthetic valve device of claim 22, wherein the second extracellular matrix material is human.

30. The prosthetic valve device of claim 22, wherein the second extracellular matrix material is secreted by one or more of endothelial cells, muscle cells, fibroblast cells, mesothelial cells, pericyte cells, macrophage cells, monocyte cells, plasma cells, mast cells, adipocyte cells, chondrocyte cells, stem cells, or a cell population differentiated from stem cells.

31. The prosthetic valve device of claim 30, wherein the second extracellular matrix material contains matrix components secreted by endothelial cells.

32. The prosthetic valve device of claim 31, wherein the endothelial cells are vascular endothelial cells.