Cartilage repair apparatus and method

• US 7,361,195 B2
• Filed: 07/15/2002
• Issued: 04/22/2008
• Est. Priority Date: 07/16/2001
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: Schwartz, Herbert E., Malaviya, Prasanna, Plouhar, Pamela L., Pelo, Mark J.
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): PRONE, CHRISTOPHER D
• Application Number:
  US10/195,347
• Publication Number:
  US 20030036801A1
• Time in Patent Office: 2,108 Days
• Field of Search: 623/14.11, 623/14.12
• US Class Current: 623/23.63
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2002/30294 Conical or frustoconical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30299 umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30751 for attaching cartilage scaffolds to underlying bone
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• 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 27/3654 Cartilage, e.g. meniscus
• 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 27/3804 : characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3852 : Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/3886 : comprising two or more cell types
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders

Abstract

An orthopaedic device for repairing and regenerating cartilage includes a plug configured to be positioned in a hole formed in the cartilage and an anchor configured to support the plug. One or both of the plug and the anchor may be formed from naturally occurring extracellular matrix such as small intestine submucosa. A method for repairing and regenerating cartilage is also disclosed.

Claims

1. A device for repairing a diseased or damaged portion of articular cartilage on a bone of a joint, the cartilage having been prepared by forming an opening therein to remove the diseased or damaged portion, the device comprising:

a plug configured to be positioned in the opening formed in the cartilage, the plug comprising a shaped and dried naturally occurring extracellular matrix, and

an anchor configured to position and hold the plug in the opening, wherein the anchor is formed of naturally occurring extracellular matrix cured and shaped to fasten into a subchondral portion of the bone.

2. The device of claim 1, wherein the anchor comprises (i) a head portion configured to support the plug and (ii) a body portion extending from the head portion to fasten into the subchondral portion of the bone.

3. The device of claim 2, wherein the body portion has outwardly extending barbs to engage the subchondral portion of the bone.

4. The device of claim 1, wherein the naturally occurring extracellular matrix from which the anchor is formed comprises SIS.

5. The device of claim 1, wherein the naturally occurring extracellular matrix from which the anchor is formed comprises comminuted SIS.

6. The device of claim 1, wherein the naturally occurring extracellular matrix from which the anchor is formed comprises crosslinked SIS.

7. The device of claim 1, wherein the plug is lyophilized onto the anchor.

8. The device of claim 1, wherein the plug is adhesively attached to the anchor.

9. The device of claim 1, wherein the plug is sutured to the anchor.

10. The device of claim 1, wherein (i) the anchor is formed with a head portion to support the plug and a body portion extending from the head portion to fasten into the subchondral portion of the bone, and (ii) the plug is formed to be sufficiently porous to receive cells from adjacent tissue or from synovial fluid and is lyophilized onto the head portion.

11. A method for repairing a diseased or damaged portion of articular cartilage on a bone, the method comprising the steps of:

forming an opening in the articular cartilage so as to remove the diseased or damaged portion thereof;

positioning a plug in the opening so as to be proximate to healthy articular cartilage, wherein the plug comprises a shaped and dried naturally occurring extracellular matrix;

securing the plug to an anchor;

forming an opening in the subchondral portion of the bone; and

wherein (i) the anchor is formed of SIS and (ii) the step of positioning the plug in the opening formed in the cartilage comprises positioning the anchor in the opening formed in the subchondral portion of the bone so as to position the plug in the opening formed in the cartilage.

12. A method of forming a device for repairing a diseased or damaged portion of articular cartilage on a bone, the method comprising the steps of:

providing a plug configured conformingly to fit into an opening formed in the cartilage to remove the diseased or damaged portion, the plug comprising a naturally occurring extracellular matrix having a porosity sufficient to promote cell migration from surrounding healthy tissue and synovial fluid, the plug being biodegradable over time in the cartilage opening and effective to synthesize new and healthy cartilage over such time to close and heal the opening, and

providing an anchor configured to position and hold the plug in the opening in contact with the healthy cartilage and subchondral portion of the bone adjacent the opening,

wherein the anchor providing step comprises forming a mass of naturally occurring extracellular matrix cured to have sufficient rigidity and strength to position and hold the plug in the opening.

13. A method of forming a device for repairing a diseased or damaged portion of articular cartilage on a bone, the method comprising the steps of:

providing a plug configured conformingly to fit into an opening formed in the cartilage to remove the diseased or damaged portion, the plug comprising a naturally occurring extracellular matrix having a porosity sufficient to promote cell migration from surrounding healthy tissue and synovial fluid, the plug being biodegradable over time in the cartilage opening and effective to synthesize new and healthy cartilage over such time to close and heal the opening, and

providing an anchor configured to position and hold the plug in the opening in contact with the healthy cartilage and subchondral portion of the bone adjacent the opening,

wherein the anchor providing step comprises forming a mass of SIS cured to have sufficient rigidity and strength to position and hold the plug in the opening.

14. A device for repairing a diseased or damaged portion of articular cartilage on a bone of a joint, the cartilage having been prepared by forming an opening therein to remove the diseased or damaged portion, the device comprising:

a plug configured to be positioned in the opening formed in the cartilage, the plug comprising a shaped naturally occurring extracellular matrix, and

an anchor configured to position and hold the plug in the opening,

wherein the anchor is formed of naturally occurring extracellular matrix cured and shaped to fasten into a subchondral portion of the bone.

15. The device of claim 14, wherein the anchor comprises (i) a head portion configured to support the plug, and (ii) a body portion extending from the head portion to fasten into the subchondral portion of the bone.

16. The device of claim 15, wherein the body portion has outwardly extending barbs to engage the subchondral portion of the bone.

17. The device of claim 14, wherein the naturally occurring extracellular matrix from which the anchor is formed comprises SIS.

18. The device of claim 14, wherein the naturally occurring extracellular matrix from which the anchor is formed comprises comminuted SIS.

19. The device of claim 14, wherein the naturally occurring extracellular matrix from which the anchor is formed comprises crosslinked SIS.

20. The device of claim 14, wherein the plug is lyophilized onto the anchor.

21. The device of claim 14, wherein the plug is adhesively attached to the anchor.

22. The device of claim 14, wherein the plug is sutured to the anchor.

23. The device of claim 14, wherein (i) the anchor is formed with a head portion to support the plug and a body portion extending from the head portion to fasten into the subchondral portion of the bone, and (ii) the plug is formed to be sufficiently porous to receive cells from adjacent tissue or from synovial fluid.

24. The device of claim 23, wherein the plug is lyophilized onto the head portion.