Apparatus for forming an implant

• US 9,138,318 B2
• Filed: 12/15/2011
• Issued: 09/22/2015
• Est. Priority Date: 04/12/2007
• Status: Active Grant

• Current Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Yao, Jian Q., Walthall, Ben, Gao, Jizong, Zaporojan, Victor
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US13/327,265
• Publication Number:
  US 20120107384A1
• Time in Patent Office: 1,377 Days
• Field of Search: 623/11.11, 623/23.1, 623/20.16, 623/23.51, 623/23.56, 623/23.58, 264/313, 264/314, 264/316, 424/548
• US Class Current: 1/1
• 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 2/3859 Femoral components
• 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 2002/30764 Cartilage harvest sites
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2300/25 Peptides having up to 20 amino acids in a defined sequence
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/3817 Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

Implants for repairing tissue defects, such as cartilage tissue defects, and methods of their preparation and use are disclosed. A mold of a tissue defect is prepared by pressing upon the defect a substrate having shape memory, such as aluminum foil. The mold, which has contours substantially conforming to those of the defect, is removed from the defect, and tissue particles are added to the mold ex vivo. A biological carrier such as biocompatible glue is also added to the mold. The combination of tissue particles and the biological carrier thereby form an implant, which retains its shape after separation from the mold. The implant can be transferred to the tissue defect, with contours of the mold matching corresponding contours of the defect.

Claims

1. An apparatus for forming a cartilage implant, comprising:

a pliable metal foil substrate shapeable to substantially conform to one or more contours of a cartilage defect and having a releasable surface, the one or more contours forming a substrate cavity at least partially surrounded by the releasable surface; and

a biocompatible carrier disposed in the substrate cavity and having an outer portion in contact with the releasable surface, the carrier comprising human juvenile cartilage particles including viable chondrocytes for combining with the biocompatible carrier, the biocompatible carrier, when cured, removable from the substrate and defining a size and shape complementing a size and shape of the substrate cavity.

2. The apparatus of claim 1, wherein the pliable substrate serves as a mold of at least a portion of the cartilage defect.

3. The apparatus of claim 2, wherein the mold has one or more perforations there through.

4. The apparatus of claim 1, wherein the pliable metal foil substrate comprises aluminum.

5. The apparatus of claim 1, wherein the pliable metal foil substrate is sterile.

6. The apparatus of claim 1, wherein the cartilage particles are obtained from a cadaver.

7. The apparatus of claim 6, wherein the cartilage particles are allogenic to a recipient thereof.

8. The apparatus of claim 1, wherein the cartilage particles are derived from cartilage generated in vitro from human juvenile chondrocytes.

9. The apparatus of claim 1, wherein the cartilage particles are articular cartilage.

10. The apparatus of claim 1, wherein the cartilage particles have a dimension from about one to about three millimeters.

11. The apparatus of claim 1, wherein the cartilage particles range in size from about 1 to about 27 mm³.

12. The apparatus of claim 1, wherein the cartilage particles are from donors less than fifteen years of age.

13. The apparatus of claim 12, wherein the cartilage particles are from donors less than two years of age.

14. The apparatus of claim 12, wherein the cartilage particles are from donors from about 20 weeks to about 13 years of age.

15. The apparatus of claim 1, wherein the cartilage particles are disposed in a liquid medium.

16. The apparatus of claim 15, wherein the liquid medium is a cell, tissue or organ storage medium.

17. The apparatus of claim 1, wherein the biocompatible carrier comprises at least one biocompatible adhesive.

18. The apparatus of claim 17, wherein the biocompatible adhesive comprises a fibrin.

19. The apparatus of claim 1, wherein the implant further comprises at least one bioactive agent.

20. The apparatus of claim 19, wherein the at least one bioactive agent is a growth factor thereof.