Cartilage replacement implant and method for producing a cartilage replacement implant

• US 20060241756A1
• Filed: 04/10/2006
• Published: 10/26/2006
• Est. Priority Date: 10/13/2003
• Status: Active Grant

• Current Assignee: TETEC Tissue Engineering Technologies AG (B. Braun Holding GmbH & Co. KG)
• Original Assignee: Aesculap AG (Lonza Group AG)
• Inventors: Aicher, Wilhelm Karl, Gaissmaier, Christoph, Fritz, Juergen
• Granted Patent: US 8,231,685 B2
• Time in Patent Office: Days
• US Class Current: 623/14.120
• 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 or resorptive
• 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 2002/30006 differing in density or specific weight
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30032 differing in absorbability or resorbability, i.e. in absorption or resorption time
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30324 differing in thickness
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00383 : Gelatin
• CPC Class Codes: A61K 35/12 : Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61L 2430/06 : for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/3817 : Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3852 : Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C12N 5/0655 : Chondrocytes; Cartilage

Abstract

To improve a cartilage replacement implant for the biological regeneration of a damaged cartilage area of articular cartilage in the human body, comprising a cell carrier which has a defect-contacting surface for placement on the damaged cartilage area and is formed and designed for colonization with human cells, so that after implantation of the cartilage replacement implant, formation of a gap between adjacent contact surfaces of the implant and surrounding recipient tissue is minimized, it is proposed that the cell carrier rest with surface-to-surface contact on a carrier and be joined to the carrier at a cell carrier surface that faces away from the defect-contacting surface. A method for producing a cartilage replacement implant is also proposed.

Claims

1. Cartilage replacement implant for the biological regeneration of a damaged cartilage area of articular cartilage in the human body, comprising a cell carrier which has a defect-contacting surface for placement on the damaged cartilage area and is formed and designed for colonization with human cells, wherein the cell carrier rests with surface-to-surface contact on a carrier and is joined to the carrier at a cell carrier surface that faces away from the defect-contacting surface.

2. Implant in accordance with claim 1, wherein the implant is made from at least one biocompatible material.

3. Implant in accordance with claim 1, wherein the at least one biocompatible material is resorbable.

4. Implant in accordance with claim 2, wherein the cell carrier and the carrier are made from different biocompatible materials.

5. Implant in accordance with claim 1, wherein the cell carrier and the carrier have resorption times of different lengths.

6. Implant in accordance with claim 5, wherein the resorption time of the carrier is longer than the resorption time of the cell carrier.

7. Implant in accordance with claim 1, wherein the cell carrier and the carrier have different resorption kinetics.

8. Implant in accordance with claim 1, wherein the carrier is formed and designed for colonization with human cells.

9. Implant in accordance with claim 1, wherein the cell carrier comprises at least two different cell carrier layers.

10. Implant in accordance with claim 1, wherein the cell carrier is inoculated with human cells.

11. Implant in accordance with claim 10, wherein the human cells are chondrocytes that are cultured and proliferated from the body'"'"'s own cells.

12. Implant in accordance with claim 1, wherein the cell carrier and the carrier have a different mechanical stability.

13. Implant in accordance with claim 12, wherein the carrier has a higher mechanical stability than the cell carrier.

14. Implant in accordance with claim 1, wherein the cell carrier and the carrier have different moduli of elasticity.

15. Implant in accordance with claim 14, wherein the modulus of elasticity of the carrier is greater than the modulus of elasticity of the cell carrier.

16. Implant in accordance with claim 1, wherein the carrier has a denser structure than the cell carrier.

17. Implant in accordance with claim 1, wherein the cell carrier is undetachably connected to the carrier.

18. Implant in accordance with claim 1, wherein the cell carrier has a sponge-like structure.

19. Implant in accordance with claim 1, wherein the cell carrier has a cell carrier layer thickness ranging from 0.3 mm to 3.5 mm.

20. Implant in accordance with claim 19, wherein the cell carrier has a cell carrier layer thickness ranging from 1.0 mm to 3.5 mm.

21. Implant in accordance with claim 1, wherein the carrier has a carrier layer thickness ranging from 0.01 mm to 0.8 mm.

22. Implant in accordance with claim 21, wherein the carrier has a carrier layer thickness ranging from 0.2 mm to 0.4 mm.

23. Implant in accordance with claim 1, wherein the cell carrier is made from a material having a pore width ranging from 30 μ

m to 500 μ

m.

24. Implant in accordance with claim 23, wherein the cell carrier is made from a material having a pore width ranging from 80 μ

m to 150 μ

m.

25. Implant in accordance with claim 1, wherein the carrier is made from a porous material having a pore width of at most 20 μ

m.

26. Implant in accordance with claim 1, wherein the cell carrier comprises at least two cell carrier elements which are independent of each other, and in that each of the at least two cell carrier elements is joined to the carrier.

27. Implant in accordance with claim 26, wherein the at least two cell carrier elements have cell carrier element surfaces, and in that cell carrier element surfaces of adjacent cell carrier elements border loosely on one another.

28. Implant in accordance with claim 26, wherein the at least two cell carrier elements are separated by at least one cut gap made by cutting into a one-piece cell carrier.

29. Implant in accordance with claim 26, wherein the at least two cell carrier elements are separated by at least one split, and the at least one split has a width ranging from 0.1 mm to 0.8 mm.

30. Implant in accordance with claim 29, wherein the at least one split is filled up with a biocompatible, resorbable material.

31. Implant in accordance with claim 26, wherein the at least one cut gap or the at least one split has a depth corresponding to at least half of the cell carrier layer thickness of the cell carrier.

32. Implant in accordance with claim 2, wherein the at least one biocompatible material is a collagen non-woven material.

33. Implant in accordance with claim 2, wherein the at least one biocompatible material is a synthetic polymer.

34. Implant in accordance with claim 2, wherein the at least one biocompatible material is gelatine.

35. Implant in accordance with claim 2, wherein the at least one biocompatible material is a collagen gel.

36. Implant in accordance with claim 2, wherein the at least one biocompatible material is a chitin derivative.

37. Implant in accordance with claim 2, wherein the at least one biocompatible material is a hyaluronic acid derivative.

38. Implant in accordance with claim 1, wherein connection means are provided for anchoring the implant to the defective cartilage area.

39. Implant in accordance with claim 38, wherein the connection means comprise resorbable suture material.

40. Implant in accordance with claim 38, wherein the connection means comprise at least one resorbable attachment pin.

41. Implant in accordance with claim 38, wherein the connection means comprise a biocompatible and resorbable adhesive.

42. Implant in accordance with claim 1, wherein the defect-contacting surface of the cell carrier is perforated.

43. Method for producing a cartilage replacement implant for the biological regeneration of damaged articular cartilage in the human body, wherein a cell carrier is used, which has a defect-contacting surface for placement on the damaged cartilage area and which is formed and designed for colonization with human cells, and the cell carrier is joined with surface-to-surface contact to a carrier at a cell carrier surface that faces away from the defect-contacting surface.

44. Method in accordance with claim 43, wherein at least one biocompatible material is used for producing the implant.

45. Method in accordance with claim 43, wherein the cell carrier is inoculated with human cells.

46. Method in accordance with claim 45, wherein chondrocytes cultured and proliferated from the body'"'"'s own cells are used as human cells.

47. Method in accordance with claim 43, wherein the cell carrier is undetachably connected to the carrier.

48. Method in accordance with claim 43, wherein at least two cell carrier elements that are independent of each other are used for formation of the cell carrier, and each of the at least two cell carrier elements is firmly joined to the carrier.

49. Method in accordance with claim 48, wherein the at least two cell carrier elements are not directly connected to each other but only via the carrier.

50. Method in accordance with claim 48, wherein the at least two cell carrier elements are made by at least one cut into a one-piece cell carrier, so that the at least two carrier elements are separated by at least one cut gap.

51. Method in accordance with claim 48, wherein the at least two cell carrier elements are separated by at least one split having at least a width ranging from 0.1 mm to 0.8 mm.

52. Method in accordance with claim 51, wherein the at least one split is filled up with a biocompatible, resorbable material.

53. Method in accordance with claim 50, wherein in order to make the at least one cut gap or the at least one split, the cell carrier is cut into at least as far as half of the layer thickness of the cell carrier.

54. Method for treating a traumatic or inflammatory, degenerated cartilage defect in cartilage in the human body, wherein a cartilage replacement implant for the biological regeneration of a damaged cartilage area of articular cartilage in the human body is inserted into the cartilage defect, the cartilage replacement implant comprising a cell carrier which has a defect-contacting surface for placement on the damaged cartilage area and is formed and designed for colonization with human cells, and the cell carrier resting with surface-to-surface contact on a carrier and being joined to the carrier at a cell carrier surface that faces away from the defect-contacting surface.

55. Method in accordance with claim 54, wherein the cartilage replacement implant is anchored to the cartilage defect with resorbable suture material.

56. Method in accordance with claim 54, wherein the cartilage replacement implant is anchored to the cartilage defect by fixing it in place with at least one resorbable attachment pin.

57. Method in accordance with claim 54, wherein the cartilage replacement implant is anchored to the cartilage defect by adhesively bonding it with a biocompatible and resorbable adhesive.

58. Method in accordance with claim 54, wherein the cartilage defect is a cartilage defect in the knee, in the intervertebral disc or in any other joint of the human body.

59. Method in accordance with claim 54, wherein the cartilage replacement implant is implanted without previous colonization of the cell carrier or the carrier with cells so as to enable stem cells to bleed from the bone marrow into the cartilage replacement implant.

60. Method in accordance with claim 59, wherein prior to insertion of the cartilage replacement implant, a subchondral plate on the bone is perforated.