Hybrid biologic-synthetic bioabsorbable scaffolds

• US 8,366,787 B2
• Filed: 06/14/2002
• Issued: 02/05/2013
• Est. Priority Date: 08/04/2000
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: Brown, Laura Jean, Chun, Iksoo, Dhanaraj, Sridevi, Malaviya, Prasanna, Melican, Mora C., Rezania, Alireza, Zhang, Li
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US10/172,347
• Publication Number:
  US 20030023316A1
• Time in Patent Office: 3,889 Days
• Field of Search: 623/23.72, 606/151, 606/154
• US Class Current: 623/23.72
• CPC Class Codes: A61B 2017/0495 Reinforcements for suture lines
• 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 three-dimensional synthetic portion. In illustrated embodiments, the naturally occurring extracellular matrix portion comprises layers of small intestine submucosa, and the three-dimensional synthetic portion comprises a foam or a three-dimensional mesh, textile, or felt.

Claims

1. A bioprosthetic device comprising

a layer of extracellular matrix material selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane, the layer of extracellular matrix material having a first surface, and

a synthetic portion having a first surface and comprising a three-dimensional fibrous material having fibers oriented along three different axes,

wherein the first surface of the extracellular matrix layer is coupled to the first surface of the synthetic portion.

2. The bioprosthetic device of claim 1, wherein the extracellular matrix layer comprises small intestinal submucosa.

3. The bioprosthetic device of claim 2, wherein the small intestinal submucosa layer comprises a plurality of small intestinal submucosa strips laminated together.

4. The bioprosthetic device of claim 3, wherein the laminated small intestinal submucosa strips are perforated.

5. The bioprosthetic device of claim 2, wherein the small intestinal submucosa comprises a woven mesh of strips of small intestinal submucosa.

6. The bioprosthetic device of claim 1, wherein the fibrous material is a bioabsorbable material selected from the group consisting of PLA, PGA, PCL, PDO, TMC, PVA, copolymers thereof, and blends thereof.

7. The bioprosthetic device of claim 1, further comprising an additional exogenous material selected from the group consisting of a bioactive agent, a biologically derived agent, a cell, a biological lubricant, a biocompatible inorganic material, and a biocompatible synthetic polymer.

8. A bioprosthetic device comprising

a non-particulate sheet of extracellular matrix material selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane, the sheet of extracellular matrix material having a first surface, and

a three-dimensional synthetic portion having a first surface and comprising a synthetic foam,

wherein the first surface of the extracellular matrix sheet is coupled to the first surface of the three-dimensional synthetic portion.

9. The bioprosthetic device of claim 8, wherein the synthetic foam has voids in size from about 20 to 400 microns.

10. The bioprosthetic device of claim 9, wherein the voids comprise about 70 to about 95 percent of the volume of the synthetic foam.

11. The bioprosthetic device of claim 8, wherein the extracellular matrix layer is perforated, and the synthetic foam penetrates into the perforations in the extracellular matrix layer.

12. The bioprosthetic device of claim 8, further comprising

a second three dimensional synthetic portion having a second surface and comprising a synthetic foam,

wherein the sheet of extracellular matrix comprises a second surface facing away from the first surface, and the second surface of the second synthetic portion is coupled to the second surface of the extracellular matrix layer.