Reinforced Biological Tissue

• US 20080027542A1
• Filed: 05/09/2007
• Published: 01/31/2008
• Est. Priority Date: 05/09/2006
• Status: Active Grant

• Current Assignee: Stout Medical Group, L.P. (Alphatec Holdings Incorporated)
• Original Assignee: Lifecell Corporation (Abbvie Incorporated)
• Inventors: Harper, John, Wagner, Christopher, McQuillan, David, Greenhalgh, E.
• Granted Patent: US 9,339,369 B2
• Time in Patent Office: Days
• US Class Current: 623/13.11
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2420/00 Materials or methods for coatings medical devices
• CPC Class Codes: A61L 2430/10 for reconstruction of tendons or ligaments
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 27/00 Materials for grafts or prostheses or for coating grafts or prostheses dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/28 Materials for coating prostheses
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3662 Ligaments, tendons
• 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: A61L 27/58 Materials at least partially resorbable by the body

Abstract

The present invention provides for an implantable medical device comprising a hybrid composite material including a first biological component such as an acellular tissue matrix and a second non-biological component for strengthening the device after implantation.

Claims

1. An implantable medical device comprising:

a composite material comprising;

a first biological component having a biomatrix; and

a second non-biological component.

2. The medical device of claim 1 wherein the first component overlays the second component for at least a portion of the composition of the composite material.

3. The medical device of claim 1 wherein the first component overlays the second component for substantially all of the composite material.

4. The medical device of claim 1 wherein the biomatrix comprises an acellular tissue matrix.

5. The medical device of claim 4 wherein the biomatrix comprises a particulate acellular tissue matrix.

6. The medical device of claim 1 wherein the second component has a higher load capacity than the first component at the time of implantation.

7. The medical device of claim 1 wherein the first component has a higher load capacity than the second component after implantation and following growth of native cells within the bio matrix.

8. The medical device of claim 1 wherein the second component comprises a bioabsorbable polymer.

9. The medical device of claim 1 wherein the second component comprises a biocompatible metal.

10. The medical device of claim 1 wherein the second component comprises polyhydroxybutyrate, polyactic acid, polyactideglycolide acid, polydioxanome or polycaprolactone.

11. The medical device of claim 1 wherein the second component is a contiguous material.

12. The medical device of claim 1 wherein the second component is a textile including non-biologic material, the textile being a knit, a weave, a braid, a nonwoven structure, or a combination of knit, weave, braid or nonwoven structures.

13. The medical device of claim 12 wherein the second component comprises a monofilament of non-biological material.

14. The medical device of claim 12 wherein the second component further comprises a braided or spun multifilament yam.

15. The medical device of claim 12 wherein the first component is integrated into the textile structure of the second component.

16. The medical device of claim 1 wherein the first component is applied to the second component as a coating, a paste, a powder, or a liquid.

17. The medical device of claim 1 wherein the composite material forms a sheet, a cylinder, a solid tube, a hollow tube or a rolled sheet.

18. The medical device of claim 1 further comprising a tether portion.

19. A method of implanting a medical device comprising:

providing a composite material to an implant site, the composite material comprising;

a first biological component comprising a biomatrix;

a second non-biological component for strengthening the composite material at the time of implantation;

providing one or more anchors to secure the medical device proximal to the implant site; and

anchoring the composite material proximal the implant wherein the anchor secures the device from within the composite material.