Crafting of cartilage

• US 9,744,043 B2
• Filed: 07/16/2007
• Issued: 08/29/2017
• Est. Priority Date: 07/16/2007
• Status: Active Grant

• Current Assignee: LifeNet Health, Inc.
• Original Assignee: LifeNet Health, Inc.
• Inventors: Chen, Silvia S., Qin, Xiaofei, Chen, Jingsong, Wolfinbarger, Jr., Lloyd
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US11/826,518
• Publication Number:
  US 20090024223A1
• Time in Patent Office: 3,697 Days
• Field of Search: 623 1412
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1635 for grafts, harvesting or transplants
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30751 for attaching cartilage scaffolds to underlying bone
• CPC Class Codes: A61F 2002/30759 Mosaicplasty, i.e. using a plurality of individual cartilage plugs for filling a substantial cartilage defect
• CPC Class Codes: A61F 2002/30762 Means for culturing cartilage
• CPC Class Codes: A61F 2002/30764 Cartilage harvest sites
• CPC Class Codes: A61F 2002/4646 Devices for cleaning bone graft
• CPC Class Codes: A61F 2002/4648 : Means for culturing bone graft
• CPC Class Codes: A61F 2002/4649 : Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0014 : having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61L 2430/06 : for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/3612 : Cartilage, synovial fluid
• 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

Abstract

The invention is directed to producing a shaped cartilage matrix isolated from a human or animal where the cartilage has been crafted to facilitate disinfection, cleaning, devitalization, recellularization, and/or integration after implantation. The invention relates to a process for repairing a cartilage defect and implantation of a cartilage graft into a human or animal by crafting the cartilage matrix into individual grafts, disinfecting and cleaning the cartilage graft, applying a pretreatment solution to the cartilage graft, removing cellular debris using an extracting solution to produce a devitalized cartilage graft, implanting the cartilage graft into the cartilage defect with or without an insertion device, and sealing the implanted cartilage graft with recipient tissue. The devitalized cartilage graft is optionally recellularized in vitro, in vivo, or in situ with viable cells to render the tissue vital before or after the implantation. The devitalized cartilage graft is also optionally stored between the removing cellular debris and the recellularizing steps.

Claims

1. A cartilage graft comprising subchondral bone, and

shaped, modified cartilage with a superficial surface, an opposing interface surface and a side surface therebetween,

wherein the shaped, modified cartilage is cartilage allograft, xenograft or autograft modified to contain one or more gaps, bores, slots, and/or channels which penetrate the interface surface but do not penetrate the superficial surface of the shaped, modified cartilage,

and the superficial surface is not in contact with the subchondral bone.

2. The cartilage graft of claim 1, wherein the shaped, modified cartilage is isolated from whole condyles, whole plateaus, hemicondyles, hemiplateaus, femoral heads, phalanges, talus, tibia, fibula, rib, intervertebral discs, menisci, nose, or ear.

3. The cartilage graft of claim 1, wherein the shaped, modified cartilage is attached to the subchondral bone at the interface surface.

4. The cartilage graft of claim 3, wherein the shaped, modified cartilage is shaped as or as part of whole condyles, whole plateaus, hemicondyles, hemiplateaus, femoral heads, talus, tibia, fibula, rib or intervertebral discs.

5. The cartilage graft of claim 1, wherein the shaped, modified cartilage has a circular, square, triangular, or star shape.

6. An osteochondral plug comprising the cartilage graft of claim 1,

wherein the subchondral bone comprises a cartilage/bone interface surface and a distal surface,

wherein the subchondral bone is attached to the shaped, modified cartilage at the cartilage/bone interface surface;

wherein the osteochondral plug is crafted into a straight cylindrical shape, a tapered cylindrical shape, a step cylindrical shape, or a dumbbell shape;

wherein the subchondral bone is modified to have one or more gaps, bores, slots, and/or channels;

wherein the one or more gaps, bores, slots, and/or channels of the subchondral bone are empty and hollow; and

wherein the one or more empty and hollow gaps, bores, slots, and/or channels of the shaped, modified cartilage are aligned with the one or more empty and hollow gaps, bores, slots, and/or channels of the subchondral bone.

7. The osteochondral plug of claim 6, wherein the subchondral bone is crafted to have the one or more empty and hollow gaps.

8. The osteochondral plug of claim 6, wherein the osteochondral plug is drilled and/or milled from the distal surface of the subchondral bone to form the one or more empty and hollow channels of the subchondral bone.

9. The osteochondral plug of claim 6, wherein the osteochondral plug is cylindrical and is drilled and/or milled on a surface of the subchondral bone at the cartilage/bone interface surface to form the one or more through channels of the subchondral bone that are perpendicular to the superficial surface of the shaped, modified cartilage.

10. The osteochondral plug of claim 6, wherein the osteochondral plug is cylindrical and is drilled and/or milled on a surface of the subchondral bone at the cartilage/bone interface surface to form the one or more empty and hollow slots of the subchondral bone that are perpendicular to the superficial surface of the shaped, modified cartilage.

11. The osteochondral plug of claim 6, wherein the side surface of the shaped, modified cartilage is modified to facilitate the integration of the osteochondral plug into a recipient tissue.

12. The osteochondral plug of claim 11, wherein the shaped, modified cartilage has a star shape or tapered cylindrical shape.

13. The osteochondral plug of claim 11, wherein the side surface of the shaped, modified cartilage comprises microparticles or embossing with a straight or non-straight line pattern or cross-line pattern onto the side surface.

14. The osteochondral plug of claim 6, wherein the side surface and/or the superficial surface of the shaped, modified cartilage is microperforated.

15. The osteochondral plug of claim 6, wherein the one or more gaps, bores, slots, and/or channels of the subchondral bone include a bone filler.

16. The osteochondral plug of claim 6, wherein the cartilage graft and the subchondral bone are naturally integrated.

17. The osteochondral plug of claim 16, wherein the naturally integrated cartilage graft and subchondral bone are harvested together from whole condyles, whole plateaus, hemicondyles, hemiplateaus, femoral heads, phalanges, talus, tibia, fibula, rib, intervertebral discs, or menisci.

18. The cartilage graft of claim 1, wherein the shaped, modified cartilage is shaped as a disc, and the disc has the one or more empty and hollow gaps that are distal to the superficial surface of the disc.

19. The cartilage graft of claim 1, wherein the shaped, modified cartilage is shaped as a disc, and the disc has the one or more empty and hollow channels that are essentially perpendicular to the superficial surface of the disc.

20. The cartilage graft of claim 1, wherein the shaped, modified cartilage is cartilage allograft.

21. A process for repairing a cartilage defect in a subject, the method comprising

a. crafting the cartilage graft of claim 1 into an individual graft;

b. disinfecting and cleaning the cartilage graft;

c. applying a pretreatment solution to the cartilage graft;

d. removing cellular debris using an extracting solution to produce a devitalized cartilage graft;

e. implanting the devitalized cartilage graft into an area in the subject comprising the cartilage defect; and

f. sealing the implanted devitalized cartilage graft to recipient tissue.

22. The process of claim 21, wherein the devitalized cartilage graft is stored prior to implantation.

23. The process of claim 22, further comprising recellularizing the devitalized cartilage graft prior to implanting.

24. The process of claim 22, further comprising recellularizing the devitalized cartilage graft after implanting.