Kit and method for fixating a prosthesis or part thereof and/or filling osseous defects

• US 8,361,161 B2
• Filed: 05/08/2009
• Issued: 01/29/2013
• Est. Priority Date: 11/10/2006
• Status: Expired due to Fees

• Current Assignee: Fondel Finance B.V.
• Original Assignee: Fondel Finance B.V.
• Inventors: Buma, Pier, Schreurs, Berend Willem, Verdonschot, Nicolaas Jacobus Joseph, Walschot, Lucas Hubert Bernard, Slooff, Thomas Johannes Josephus Hubertus, Van't Wout, Willem Cornelis Sr.
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US12/463,038
• Publication Number:
  US 20090306673A1
• Time in Patent Office: 1,362 Days
• Field of Search: 623/22.11, 623/22.33, 623/23.19, 623/23.2, 623/23.26, 623/23.29, 623/23.37, 623/23.48, 623 235- 236, 623/23.61, 623/23.62, 623/23.73, 623/23.74
• US Class Current: 623/22.11
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 17/8847 for removing cement from a bone cavity using surgical bone chisels, drills, mills, rasps, reamers or scrapers A61B17/16; using laser A61B18/20; using ultrasonic surgical instruments A61N7/00
• CPC Class Codes: A61B 17/885 Tools for expanding or compacting bones or discs or cavities therein A61B17/8805, A61B17/7097 take precedence
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/30723 Plugs or restrictors for sealing a cement-receiving space tools for inserting plugs A61F2/4614; sealing collars for use during cementing A61B17/8808
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2/3676 Distal or diaphyseal parts of shafts
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/468 Testing instruments for artificial joints for testing non-implantable prostheses A61F2/76
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30588 filled with solid particles
• CPC Class Codes: A61F 2002/3069 Revision endoprostheses
• CPC Class Codes: A61F 2002/30726 Centering or guiding rods, e.g. for insertion of femoral shafts
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/4631 : the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/00592 : Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61F 2310/00928 : Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass
• CPC Class Codes: A61L 27/04 : Metals or alloys
• CPC Class Codes: A61L 27/16 : obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 33/12 : Homopolymers or copolymers of methyl methacrylate
• CPC Class Codes: C23C 30/00 : Coating with metallic material characterised only by the composition of the metallic material, i.e. not characterised by the coating process C23C26/00, C23C28/00 take precedence

Abstract

Kit of parts, comprising:

• • a prosthesis or prosthesis part having at least one contact surface;
  • metal granules having an internal porosity;
  • bone cement;
  • and further comprising titanium granules for use in a kit of parts, which granules preferably are osteoconductive, which granules preferably are coated with a coating from the group of osteoconductive or osteoinductive coatings, or coatings comprising bioceramic, bioglass or osteoconductive or osteoinductive molecules or fluids or cells.

Claims

1. Kit of separate parts comprising

a prosthesis or prosthesis part having at least one contact surface;

metal granules having an internal porosity; and

bone cement,

wherein the bone cement, the metal granules and the prosthesis or prosthesis part are individually inserted within a patient'"'"'s body,

wherein the granules cover the at least one contact surface with a layer of granules having an average thickness of at least one time the average size of the granules,

wherein the bone cement covers the layer of granules while the layer of granules are covering said at least one contact surface, and the bone cement penetrates the layer of granules over a distance of at least 2 mm.

2. Kit of parts according to claim 1, further comprising a mesh material for covering at least part of an outer surface formed by a layer of said granules on said at least one contact surface.

3. Kit of parts according to claim 2, wherein said mesh is such that said granules can be contained by said mesh.

4. Kit of parts according to claim 1, further comprising means for compacting said granules in an opening in a bone.

5. Kit of parts according to claim 4, wherein said compacting means is provided with a contact part having a configuration similar to at least one contact surface to be introduced into said opening.

6. Kit of parts according to claim 1, further comprising means for introducing said granules into an opening in a bone.

7. Kit of parts according to claim 1, wherein at least 50% of said granules by volume has an average size between 1 and 10 mm.

8. Kit of parts according to claim 7, wherein substantially all of said granules have an average size between 1 and 10 mm.

9. Kit of parts according to claim 1, wherein said granules have an average porosity of 40-90%.

10. Kit of parts according to claim 1, wherein said granules have a surface roughness over 5.5 Ra.

11. Kit of parts according to claim 1, wherein said granules have been formed using a method of purification of titanium with titanium tetrachloride (TiCl₄).

12. Kit of parts according to claim 1, wherein said granules have an osteoconductive coating of calcium phosphate or bioactive glass.

13. Kit of parts according to claim 12, wherein said coating has an average thickness of 0.5 to 100 micrometer.

14. Kit of parts according to claim 1, wherein said granules are made at least partly of titanium.

15. Kit of parts according to claim 1, wherein said bone cement includes an acrylate.

16. Titanium granules for use in a kit of parts according to claim 1, having between 50 and 95% porosity and a diameter between 1 and 10 mm, which granules are osteoconductive, which granules are coated with osteoconductive or osteoinductive coatings, or coatings comprising bioceramic, bioglass or osteoconductive or osteoinductive molecules or fluids or cells.

17. Kit of parts, according to claim 1, further comprising a compacting device wherein said compacting device has a longitudinal direction and is provided with an impact surface at a longitudinal end for driving said compacting device in said longitudinal direction, and an at least partly tapering portion, tapering in a direction facing away from said impact surface.

18. Kit of parts according to claim 1, wherein the amount of granules is sufficient to cover the at least one contact surface with a layer of granules having an average thickness of between 1 and 10 times the average size of the granules.

19. Kit of parts according to claim 1, wherein the amount of granules is sufficient to cover the at least one contact surface with a layer of granules having an average thickness of between 1 and 4 times the average size of the granules.

20. Kit of parts according to claim 1, wherein the amount of bone cement is sufficient to cover the granules in a layer of granules covering said at least one contact surface to a depth of at least 2 mm plus a penetration distance into the layer of granules over an average distance of 2-X mm, wherein X is equal to the diameter of a granule in an upper size range in said layer of granules.

38. Titanium granules for use in a kit of parts according to claim 1, having between 50 and 95% porosity and a diameter between 1 and 10 mm, which granules are osteoconductive, which granules are coated with a coating of osteoconductive or osteoinductive coatings, or coatings comprising bioceramic, bioglass or osteoconductive or osteoinductive molecules or fluids or cells.

21. Kit of separate parts comprising

a prosthesis or prosthesis part having at least one contact surface;

metal granules having an internal porosity; and

bone cement,

wherein the bone cement, the metal granules and the prosthesis or prosthesis part are individually inserted within a patient'"'"'s body,

wherein the granules cover the at least one contact surface with a layer of granules having an average thickness of at least one time the average size of the granules, and

wherein the cement fills pores of said granules and openings between said granules up to an average of at least one third of said layer of granules.

22. Kit of parts according to claim 21, wherein the amount of granules is sufficient to cover the at least one contact surface with a layer of granules having an average thickness of between 1 and 10 times the average size of the granules.

23. Kit of parts according to claim 21, wherein the amount of granules is sufficient to cover the at least one contact surface with a layer of granules having an average thickness of between 1 and 4 times the average size of the granules.

24. Kit of parts according to claim 21, further comprising a mesh material for covering at least part of an outer surface formed by a layer of said granules on said at least one contact surface.

25. Kit of parts according to claim 24, wherein said mesh is such that said granules can be contained by said mesh.

26. Kit of parts according to claim 21, further comprising means for compacting said granules in an opening in a bone.

27. Kit of parts according to claim 26, wherein said compacting means is provided with a contact part having a configuration similar to at least one contact surface to be introduced into said opening.

28. Kit of parts according to claim 21, further comprising means for introducing said granules into an opening in a bone.

29. Kit of parts according to claim 21, wherein at least 50% of said granules by volume has an average size between 1 and 10 mm.

30. Kit of parts according to claim 29, wherein substantially all of said granules have an average size between 1 and 10 mm.

31. Kit of parts according to claim 21, wherein said granules have an average porosity of 40-90%.

32. Kit of parts according to claim 21, wherein said granules have a surface roughness over 5.5 Ra.

33. Kit of parts according to claim 21, wherein said granules have been formed using a method of purification of titanium with titanium tetrachloride (TiCl₄).

34. Kit of parts according to claim 21, wherein said granules have an osteoconductive coating of calcium phosphate or bioactive glass.

35. Kit of parts according to claim 34, wherein said coating has an average thickness of 0.5 to 100 micrometer.

36. Kit of parts according to claim 21, wherein said granules are made at least partly of titanium.

37. Kit of parts according to claim 21, wherein said bone cement includes an acrylate.

39. Kit of parts, according to claim 21, further comprising a compacting device wherein said compacting device has a longitudinal direction and is provided with an impact surface at a longitudinal end for driving said compacting device in said longitudinal direction, and an at least partly tapering portion, tapering in a direction facing away from said impact surface.

40. Kit of separate parts comprising

a prosthesis or prosthesis part having at least one contact surface;

metal granules having an internal porosity; and

bone cement,

wherein the kit of parts is arranged such that during use, when the bone cement, the metal granules and the prosthesis or prosthesis part are inserted into a patient'"'"'s body,

the granules cover the at least one contact surface with a layer of granules having an average thickness of at least one time the average size of the granules,

wherein the bone cement covers the layer of granules while the layer of granules are covering said at least one contact surface, and the bone cement penetrates the layer of granules over a distance of at least 2 mm.

41. Kit of parts according to claim 40, wherein the amount of granules is sufficient to cover the at least one contact surface with a layer of granules having an average thickness of between 1 and 10 times the average size of the granules.

42. Kit of parts according to claim 40, wherein the amount of granules is sufficient to cover the at least one contact surface with a layer of granules having an average thickness of between 1 and 4 times the average size of the granules.

43. Kit of parts according to claim 40, further comprising a mesh material for covering at least part of an outer surface formed by a layer of said granules on said at least one contact surface.

44. Kit of parts according to claim 43, wherein said mesh is such that said granules can be contained by said mesh.

45. Kit of parts according to claim 40, further comprising means for compacting said granules in an opening in a bone.

46. Kit of parts according to claim 45, wherein said compacting means is provided with a contact part having a configuration similar to at least one contact surface to be introduced into said opening.

47. Kit of parts according to claim 40, further comprising means for introducing said granules into an opening in a bone.

48. Kit of parts according to claim 40, wherein at least 50% of said granules by volume has an average size between 1 and 10 mm.

49. Kit of parts according to claim 48, wherein substantially all of said granules have an average size between 1 and 10 mm.

50. Kit of parts according to claim 40, wherein said granules have an average porosity of 40-90%.

51. Kit of parts according to claim 40, wherein said granules have a surface roughness over 5.5 Ra.

52. Kit of parts according to claim 40, wherein said granules have been formed using a method of purification of titanium with titanium tetrachloride (TiCl₄).

53. Kit of parts according to claim 40, wherein said granules have an osteoconductive coating of calcium phosphate or bioactive glass.

54. Kit of parts according to claim 53, wherein said coating has an average thickness of 0.5 to 100 micrometer.

55. Kit of parts according to claim 40, wherein said granules are made at least partly of titanium.

56. Kit of parts according to claim 40, wherein said bone cement includes an acrylate.

57. Titanium granules for use in a kit of parts according to claim 40, having between 50 and 95% porosity and a diameter between 1 and 10 mm, which granules are osteoconductive, which granules are coated with a coating of osteoconductive or osteoinductive coatings, or coatings comprising bioceramic, bioglass or osteoconductive or osteoinductive molecules or fluids or cells.

58. Kit of parts, according to claim 40, further comprising a compacting device wherein said compacting device has a longitudinal direction and is provided with an impact surface at a longitudinal end for driving said compacting device in said longitudinal direction, and an at least partly tapering portion, tapering in a direction facing away from said impact surface.

59. Kit of separate parts comprising

a prosthesis or prosthesis part having at least one contact surface;

metal granules having an internal porosity; and

bone cement,

wherein the kit of parts is arranged such that during use, when the bone cement, the metal granules and the prosthesis or prosthesis part are inserted into a patient'"'"'s body,

the granules cover the at least one contact surface with a layer of granules having an average thickness of at least one time the average size of the granules, and

wherein the cement fills pores of said granules and openings between said granules up to an average of at least one third of said layer of granules.

60. Kit of parts according to claim 59, wherein the amount of granules is sufficient to cover the at least one contact surface with a layer of granules having an average thickness of between 1 and 10 times the average size of the granules.

61. Kit of parts according to claim 59, wherein the amount of granules is sufficient to cover the at least one contact surface with a layer of granules having an average thickness of between 1 and 4 times the average size of the granules.

62. Kit of parts according to claim 59, further comprising a mesh material for covering at least part of an outer surface formed by a layer of said granules on said at least one contact surface.

63. Kit of parts according to claim 62, wherein said mesh is such that said granules can be contained by said mesh.

64. Kit of parts according to claim 59, further comprising means for compacting said granules in an opening in a bone.

65. Kit of parts according to claim 64, wherein said compacting means is provided with a contact part having a configuration similar to at least one contact surface to be introduced into said opening.

66. Kit of parts according to claim 59, further comprising means for introducing said granules into an opening in a bone.

67. Kit of parts according to claim 59, wherein at least 50% of said granules by volume has an average size between 1 and 10 mm.

68. Kit of parts according to claim 67, wherein substantially all of said granules have an average size between 1 and 10 mm.

69. Kit of parts according to claim 59, wherein said granules have an average porosity of 40-90%.

70. Kit of parts according to claim 59, wherein said granules have a surface roughness over 5.5 Ra.

71. Kit of parts according to claim 59, wherein said granules have been formed using a method of purification of titanium with titanium tetrachloride (TiCl₄).

72. Kit of parts according to claim 59, wherein said granules have an osteoconductive coating of calcium phosphate or bioactive glass.

73. Kit of parts according to claim 72, wherein said coating has an average thickness of 0.5 to 100 micrometer.

74. Kit of parts according to claim 59, wherein said granules are made at least partly of titanium.

75. Kit of parts according to claim 59, wherein said bone cement includes an acrylate.

76. Titanium granules for use in a kit of parts according to claim 59, having between 50 and 95% porosity and a diameter between 1 and 10 mm, which granules are osteoconductive, which granules are coated with a coating of osteoconductive or osteoinductive coatings, or coatings comprising bioceramic, bioglass or osteoconductive or osteoinductive molecules or fluids or cells.

77. Kit of parts, according to claim 59, further comprising a compacting device wherein said compacting device has a longitudinal direction and is provided with an impact surface at a longitudinal end for driving said compacting device in said longitudinal direction, and an at least partly tapering portion, tapering in a direction facing away from said impact surface.