Reinforced small intestinal submucosa (SIS)

• US 6,638,312 B2
• Filed: 07/30/2001
• Issued: 10/28/2003
• Est. Priority Date: 08/04/2000
• Status: Expired due to Term

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Orthopaedics Incorporated (Johnson & Johnson)
• Inventors: Malaviya, Prasanna, Melican, Mora C., Plouhar, Pamela L., Ferguson, Joe W.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): STEWART, ALVIN J
• Application Number:
  US09/918,116
• Publication Number:
  US 20020038151A1
• Time in Patent Office: 820 Days
• Field of Search: 623/23.72, 623/23.63, 623/23-3-, 623/15.11, 623/15.12
• US Class Current: 623/23.72
• 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

A bioprosthetic device is provided for soft tissue attachment, reinforcement, and or reconstruction. The device comprises a naturally occurring extracellular matrix portion and a synthetic portion. In illustrated embodiments, the naturally occurring extracellular matrix portion comprises layers of small intestine submucosa, and the synthetic portion comprises one or more rows of fibers or mesh positioned between layers of the small intestine submucosa.

Claims

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

a naturally occurring extracellular matrix portion;

a synthetic portion coupled to the naturally occurring extracellular matrix portion, the synthetic portion including at least one mesh member wherein the naturally occurring extracellular matrix portion is an SIS portion; and

wherein the mesh member is coated with comminuted SIS.

2. The bioprosthetic device of claim 1, wherein the SIS portion is dehydrated and is formed to include a top tissue layer of SIS coupled to a bottom tissue layer of SIS and the synthetic portion is coupled to and positioned to lie between the top tissue layer and the bottom tissue layer.

3. The bioprosthetic device of claim 1, wherein the SIS portion includes multiple sections of SIS each separated by the synthetic portion and wherein each section of SIS includes multiple layers of SIS tissue.

4. The bioprosthetic device of claim 3, wherein the synthetic portion includes a mesh member coupled to at least one section of SIS.

5. The bioprosthetic device of claim 1, wherein the mesh member is bioabsorbable.

6. The bioprosthetic device of claim 1, wherein the SIS portion is dehydrated and defines a length and a width and the mesh member defines the same length and width.

7. The bioprosthetic device of claim 5, wherein the SIS portion defines a length and a width and the mesh portion defines a length and a width greater than the length and width of the SIS portion.

8. The bioprosthetic device of claim 1, further comprising means for reinforcing the bioprosthetic device.

9. The bioprosthetic device of claim 8, wherein means for reinforcing the bioprosthetic device comprise a layer of comminuted SIS coating the synthetic device.

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

, Vicryl™

, and Mersilene™

.

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

a top section of small intestinal submucosa (SIS) including multiple SIS tissue layers each having a first surface area,

a bottom section of SIS including multiple SIS tissue layers each having a second surface area, wherein the first area and the second area are the same;

and a mesh device having a third surface area, greater than the first and the second areas

and being coupled to and positioned to lie between the top and bottom sections of SIS.