Reinforced small intestinal submucosa

• US 20040059431A1
• Filed: 09/05/2003
• Published: 03/25/2004
• Est. Priority Date: 08/04/2000
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Orthopaedics Incorporated (Johnson & Johnson)
• Inventors: Melican, Mora C., Malaviya, Prasanna, Plouhar, Pamela L., Ferguson, Joe W.
• Granted Patent: US 7,160,333 B2
• Time in Patent Office: Days
• US Class Current: 623/23.74
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• 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 27/3683 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 27/40 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Bioprosthetic devices for soft tissue attachment, reinforcement, or construction are provided. The devices comprise a sheet of naturally occurring extracellular matrix and a sheet of synthetic mesh coupled to the naturally occurring extracellular matrix portion.

Claims

1. A bioprosthetic device for soft tissue attachment, reinforcement, or construction, the device comprising

a sheet of naturally occurring extracellular matrix;

and

a sheet of synthetic mesh coupled to the naturally occurring extracellular matrix portion.

2. The bioprosthetic device of claim 1, wherein the sheet of naturally occurring extracellular matrix is a sheet of SIS.

3. The bioprosthetic device of claim 1, wherein the sheet of naturally occurring extracellular matrix and the sheet of synthetic mesh are generally planar.

4. The bioprosthetic device of claim 1, wherein the sheet of naturally occurring extracellular matrix is a top tissue layer of naturally occurring extracellular matrix and is coupled to a bottom tissue layer of naturally occurring extracellular matrix, and the sheet of synthetic mesh is coupled to and positioned to lie between the top tissue layer and the bottom tissue layer.

5. The bioprosthetic device of claim 1, wherein the sheet of synthetic mesh includes a length and a width equal to or greater than a length and a width of the sheet of naturally occurring extracellular matrix.

6. The bioprosthetic device of claim 5, wherein the naturally occurring extracellular matrix is dehydrated and length and width of the sheet of naturally occurring extracellular matrix is the same as the length and width of the sheet of synthetic mesh.

7. The bioprosthetic device of claim 4, wherein the sheet of naturally occurring extracellular matrix is circular in shape and the sheet of synthetic mesh is circular in shape

8. The bioprosthetic device of claim 1, wherein the sheet of naturally occurring extracellular matrix comprises multiple layers of naturally occurring extracellular matrix.

9. The bioprosthetic device of claim 1, wherein the sheet of naturally occurring extracellular matrix is perforated.

10. The bioprosthetic device of claim 1, further comprising multiple sheets of naturally occurring extracellular matrix and multiple sheets of synthetic mesh, wherein the bioprosthetic device comprises a stack of the sheets of naturally occurring extracellular matrix separated by the sheets of synthetic mesh.

11. The bioprosthetic device of claim 1, wherein the sheet of synthetic mesh is coated with comminuted SIS.

12. The bioprosthetic device of claim 1, wherein the sheet of synthetic mesh is bioabsorbable.

13. The bioprosthetic device of claim 1, wherein the sheet of synthetic mesh has a rate of absorption that is slower than a rate of absorption of the sheet of naturally occurring extracellular matrix.

14. The bioprosthetic device of claim 1, wherein the synthetic portion comprises a material selected from the group consisting of Prolene™

, Vicryl™

, and Mersilene™

.

15. A bioprosthetic device for soft tissue attachment, reinforcement, and/or reconstruction, the device comprising

a top sheet of small intestinal submucosa (SIS) comprising multiple SIS tissue layers, the top sheet having a first surface area,

a bottom sheet of SIS comprising multiple SIS tissue layers, the bottom sheet having a second surface area, wherein the first area and second area are the same;

and a mesh device having a third surface area, the mesh device coupled to and positioned to lie between the top and bottom sheets of SIS.

16. The bioprosthetic device of claim 15, wherein the third surface area is equal to the first and second surface areas.

17. The bioprosthetic device of claim 15, wherein the third surface area is greater than the first and second surface areas.