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

• US 7,959,554 B2
• Filed: 09/19/2006
• Issued: 06/14/2011
• 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: Hodde, Jason P., McAlexander, Chad S., Graham, Matthew R., Fette, Clay
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Dorna; Carrie
• Application Number:
  US11/523,450
• Publication Number:
  US 20070166395A1
• Time in Patent Office: 1,729 Days
• Field of Search: 600 29- 32, 600/37
• US Class Current: 600/37
• 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 multilaminate construct having two or more layers of remodelable collagenous extracellular matrix (ECM) material bonded to one another, the multilaminate construct having a first region in which the layers are bonded to one another during a drying method other than lyophilization and a second region in which the layers are bonded to one another during a lyophilization drying method, wherein the first bonded region comprises collagenous ECM material having a more collapsed matrix structure relative to the second bonded region, and wherein the second bonded region comprises lyophilized collagenous ECM material having a more open matrix structure than the first bonded region.

2. The product of claim 1, wherein the multilaminate construct has three or more layers.

3. The product of claim 1, wherein the first region and the second region are effective for promoting 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 has a square geometric configuration.

6. The product of claim 1, wherein the extracellular matrix material is selected from the group consisting, of submucosa, renal capsule membrane, durmater, pericardium, serosa, peritoneum, and basement membrane.

7. The product of claim 6, wherein the extracellular matrix material comprises submucosa.

8. The product of claim 7, wherein submucosa comprises porcine small intestine submucosa.

9. The product of claim 1, wherein said first region comprises a band that extends substantially across an entire dimension of said extracellular matrix material.

10. The product of claim 1, wherein said first region comprises a band that travels along the perimeter of the matrix material.

11. The product of claim 1, wherein said first region comprises a first elongate band and a second elongate band that intersect one another.

12. The product of claim 1, wherein said first region is in the form of a lattice.

13. The product of claim 1, wherein the medical graft product is a urethral sling.

14. The product of claim 13, wherein the sling has two arms, and wherein said second region includes at least a portion of each of said two arms.

15. The product of claim 13, wherein said first region includes a center portion of the sling.

16. The product of claim 13, wherein the first region comprises a center portion of the sling and the second region comprises at least a portion of each of two arms of the sling.

17. The product of claim 1, wherein the product is a hernia repair graft.