Medical graft products with differing regions and methods and systems for producing the same

• US 20070166395A1
• Filed: 09/19/2006
• Published: 07/19/2007
• Est. Priority Date: 03/29/2004
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Inventors: Fette, Clay, Graham, Matthew, McAlexander, Chad, Hodde, Jason
• Granted Patent: US 7,959,554 B2
• Time in Patent Office: Days
• US Class Current: 424/551
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61L 2430/22 for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• 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 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• 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 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/917 Collagen

Abstract

Described are methods and systems for drying remodelable materials, such that selective regions of the remodelable materials have differing properties. Also described are medical graft products having selective regions of differing material properties. Advantageous remodelable materials include collagenous extracellular matrix material, such as small intestine submucosa.

Claims

1. A medical graft product, comprising a remodelable material having a first region and a second region, wherein the first region and the second region are formed by differentially drying the remodelable material.

2. The product of claim 1, wherein the first region comprises a first matrix structure and the second region comprises a second matrix structure.

3. The product of claim 1, wherein the first region and the second region differentially promote tissue of the patient to remodel the remodelable material.

4. The product of claim 1, wherein the first region comprises a lattice and the second region is framed by the lattice.

5. The product of claim 4, wherein the lattice structure has a square geometric configuration.

6. A medical graft product, comprising:

at least one layer, said at least one layer having a top surface and a bottom surface, wherein said top surface further comprises a plurality of regions.

7. The product of claim 6, wherein the at least one layer comprises an extracellular matrix material.

8. The product of claim 7, wherein the extracellular matrix material comprises mammalian submucosa.

9. The product of claim 8, wherein mammalian submucosa comprises porcine small intestine submucosa.

10. A method for making a medical graft product, comprising:

providing a hydrated extracellular matrix material;

selectively compressing at least one region of the hydrated extracellular matrix material;

freezing the selectively compressed extracellular matrix material; and

removing hydrant from the compressed extracellular matrix material while frozen.

11. The method of claim 10, wherein selectively compressing at least one region comprises:

pressing a band into the extracellular matrix material, wherein the band travels along the perimeter of the matrix material.

12. A method for differentially drying a medical graft product, comprising:

providing a frozen remodelable material;

placing a covering material onto at least one selective region of the frozen remodelable material; and

drying the covered remodelable material under a vacuum while frozen.

13. A differential drying method, comprising:

freezing an extracellular matrix material; and

drying the frozen extracellular matrix material while under a vacuum, wherein selective regions of the extracellular matrix material are temperature controlled during drying.

14. A differential drying method, comprising:

compressing selective portions of a remodelable material;

freezing the selectively compressed material; and

drying the frozen material while selectively compressed.

15. A method for bonding remodelable material, comprising:

providing at least two extracellular matrix layers, the at least two extracellular matrix layers in contact to form at least one overlapping region;

compressing selective portions of the at least one overlapping region;

freezing the at least two extracellular matrix layers while the selective portions of the at least one overlapping region are compressed; and

removing hydrant from the at least two extracellular matrix layers having selective portions of the at least one overlapping region compressed while frozen.

16. An extracellular matrix material, comprising:

a first region and a second region, wherein said first region comprises a collapsed matrix structure and said second region comprises a non-collapsed matrix structure.

17. A medical graft product, comprising:

an extracellular matrix material having a plurality of regions, wherein at least one of said plurality of regions comprises an open matrix structure, and at least one of said plurality of regions comprises a collapsed matrix structure.

24. The medical graft product of claim 17, wherein the medical graft product comprises a urethral sling, bladder sling, or combination urethral and bladder sling.

25. The medical graft product of claim 24, wherein at least a portion of the sling center comprises the collapsed matrix structure.

18. An extracellular matrix construct, comprising:

a first extracellular matrix layer;

a second extracellular matrix layer; and

said first extracellular matrix layer and second extracellular matrix layer compression bonded to one another in selected regions, said selected regions exhibiting a collapsed matrix structure relative to other regions of said first extracellular matrix layer and second extracellular matrix layer.

19. The construct of claim 18, wherein said selected regions include at least one band extending substantially across an entire dimension of said construct.

20. The construct of claim 18, wherein said selected regions include at least two bands extending substantially across an entire dimension of said construct.

21. The construct of claim 20, wherein said first and second bands intersect one another.

22. The construct of claim 21, wherein said selected regions form a grid.

23. The construct of claim 18, wherein said selected regions encompass substantially the entire periphery of said construct.

26. A method for making a medical graft product, comprising:

providing a hydrated extracellular matrix material, wherein the hydrated matrix material further comprises one or more shielding elements on a surface of the hydrated material; and

drying the hydrated matrix material having one or more shielding elements on a surface, wherein drying comprises lyophilization.

27. The method of claim 26, wherein the hydrated extracellular matrix material comprises a multilaminate extracellular matrix material.

28. The method of claim 26, wherein lyophilization comprises:

placing the hydrated matrix material having one or more shielding elements on a surface within a vacuum chamber; and

evacuating the vacuum chamber containing the hydrated matrix material having one or more shielding elements on a surface.

29. The method of claim 28, wherein the vacuum chamber is rigid.