Articular surface repair

• US 5,067,964 A
• Filed: 12/13/1989
• Issued: 11/26/1991
• Est. Priority Date: 12/13/1989
• Status: Expired due to Fees

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Corporation
• Inventors: Richmond, James W., Block, John J.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US07/450,903
• Time in Patent Office: 713 Days
• Field of Search: 623/16, 623/18, 623/22, 623/23, 623/66, 623/11, 623/13
• US Class Current: 623/14.12
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30672 temporary
• CPC Class Codes: A61F 2002/30761 Support means for artificial cartilage, e.g. cartilage defect covering membranes
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

An articular cartilage repair piece and methods of forming and using same to substitute for a cut-out piece of damaged articular cartilage on a bone in an articulated joint in a mammal. The repair piece includes a backing layer of non-woven, felted fibrous material which is conformable to flat and curved surfaces. The front face of the backing layer is either uncoated or covered by a coating of tough pliable material having front surface which is tough, smooth and slippery in the presence of the natural synovial fluid of the joint and responds naturally as the repair site interfaces with underlying meniscus cartilage or articular cartilage of an opposing surface through articulating motion in the joint of a patient.

Claims

1. An articular cartilage repair piece to be substituted for damaged articular cartilage on a bone in an articulated joint in a mammal, comprising:

a repair piece including a backing layer of nonwoven, felted fibrous material, the material being selected from the group consisting of PTFE and polyester, the backing layer being limp and readily conformable to flat and curved surfaces, the backing layer having a back face for application to the site of the damaged articular cartilage for eventual anchoring to the bone, the repair piece having a front face for opposing and coacting interface with adjacent material of the joint, said front face being defined by a coating of tough pliable material having a front surface which is smooth and is slippery in the presence of the natural synovial fluid in the joint, in which said coating is of polyurethane.

2. The apparatus of claim 1 in which the polyurethane coat is 1/2 to 2 mm thick.

3. The apparatus of claim 1 including means for temporarily fixing the repair piece in place of the removed piece of damaged articular cartilage.

4. The apparatus of claim 3 in which said temporary fixing means comprises sutures sewn through the edge portion of the repair piece and the adjacent edge portion of the existing natural articular cartilage layer left after removal of the cut-out piece.

5. The apparatus of claim 3 in which said temporary fixing means comprises an adhesive layer applied to said back face of said backing layer of said repair piece for application to and adhesion to bone exposed by removal of a piece of damaged articular cartilage.

6. The apparatus of claim 5 in which said adhesive layer is of a fibrinogen-thrombin adhesive.

7. The apparatus of claim 3 in which said temporary fixing means comprises resorbable fasteners extending at least through said backing layer, the fasteners extending through and beyond said back face of said backing layer so as to protrude beyond the latter and be insertable into the bone exposed by removal of the cut-out piece.

8. The apparatus of claim 3 in which said temporary fixing means comprises elongate discrete fasteners selected from the group consisting of pins, staples, nails, clamps and screws and extending at least out through the back of said backing layer to engage underlying bone.

9. The apparatus of claim 7 in which said fasteners consist of a material selected from the group consisting of polyglycolic acid or polylactic acid and a composite of polyglycolic and polylactic acids, the pins being approximately 1/32 of an inch in diameter and 1/4 inch long.

10. The apparatus of claim 3 in which said temporary fixing means comprises flange means extending radially beyond a rear most portion of said backing layer and adapted to mechanically lock in an undercut opening in bone beneath the damaged articular cartilage to be replaced by said repair piece.

11. An articular cartilage repair piece to be substituted for a piece of damaged articular cartilage on a bone in an articulated joint in a mammal, comprising:

a repair piece including a backing layer of nonwoven, felted fibrous material, the backing layer being limp and readily conformable to flat and curved surfaces, the backing layer having a back face for application to the face of the bone exposed by removal of a portion of the articular cartilage containing the damaged area and for eventual anchoring to the bone by tissue ingrowth from the bone, the repair piece having a front face for slidably opposing and coacting with adjacent material of the joint generally in the manner of the front face of the natural articular cartilage, the backing layer being of PTFE and about 1.2 mm thick, the front face being defined by a coating of tough rubbery material having a front surface which is smooth and is slippery in the presence of the natural synovial fluid in the joint, the coating being of polyurethane and being about 1/2 to 2 mm thick, and including means for temporarily fixing the repair piece in place of the piece of damaged articular cartilage.

12. In a repair for a damaged portion in an articular cartilage layer fixed to and protectively coating a bone surface in an articulated joint of a mammal, wherein the damaged portion of the articular cartilage layer has been cut away to leave a hole of desired shape and area through the articular cartilage layer, at the bottom of which hole a corresponding area of underlying bone is exposed, the surfaces bounding the hole thus being defined by the surrounding articular cartilage layer and the exposed underlying bone, and wherein the articular cartilage layer has (1) a back side continuously fixed to a substantial surface area of the bone in such articulated joint and has (2) a front face facing another component of the joint in mutually slidable relation therewith, which front face has a smooth surface which is slippery in the presence of the usual synovial fluid present in the articulated joint, such repair comprising:

a plug of thickness corresponding to the thickness of the articular cartilage surrounding the hole and of shape and area corresponding to the shape and area of the hole, said plug being a laminate including;

(A) a backing layer having means for facing and engaging the bone exposed at the bottom of the hole and receiving tissue ingrowth from said bone exposed at the bottom of the hole, the last-mentioned means defining the back face of said backing layer and comprising exposed fibers of felted material, said backing layer further having means for facing and engaging the articular cartilage forming the periphery of the hole and for receiving tissue ingrowth therefrom, the last-mentioned means defining the peripheral face of said backing layer of said plug and comprising exposed fibers of felted material, said backing layer being formed by a layer of said felted material, said material being a non-woven, non-mesh fibrous material, the backing layer being limp and readily conformable to flat and curved surfaces;

(B) means for simulating the front face of the articular cartilage and comprising a synthetic coating of tough rubbery material which is smooth, said coating being slippery in the presence of the natural synovial fluid of the joint, said coating having means for flushly and smoothly continuing the front face of the articular cartilage layer across the hole in such articular cartilage layer; and

(C) means for engaging surfaces bounding the hole in the articular cartilage layer and temporarily fixing the plug in the hole while awaiting tissue ingrowth to permanently fix said plug in said hole.

13. The apparatus of claim 12 in which the material of said backing layer is selected from the group consisting of PTFE and polyester.

14. The apparatus of claim 12 in which said means for simulating the front face of the articular cartilage and defining said coating is of polyurethane.

15. The apparatus of claim 12 in which the means for temporarily fixing the plug in the hole is an adhesive means interpositioned between the opposed surface of the plug and the tissue bounding the hole.

16. The apparatus of claim 15 in which said adhesive layer is of fibrinogen-thrombin glue.

17. The apparatus of claim 12 in which said means for temporarily fixing the plug in the hole comprises means for insertion at least through said backing layer and into the bone at the bottom of the hole, such means for insertion comprising pins of bioabsorbable material.

18. The apparatus of claim 17 in which said means temporarily fixing the plug in the hole further includes a fibrinogen-thrombin glue located on said plug for engagement with tissue defining the hole.