KIT AND METHOD FOR FIXATING A PROSTHESIS OR PART THEREOF AND/OR FILLING OSSEOUS DEFECTS

• US 20090306673A1
• Filed: 05/08/2009
• Published: 12/10/2009
• Est. Priority Date: 11/10/2006
• Status: Active Grant

• Current Assignee: Fondel Finance B.V.
• Original Assignee: Fondel Finance B.V.
• Inventors: Van't Wout, Willem Cornelis SR., Buma, Pier, Verdonschot, Nicolaas Jacobus Joseph, Walschot, Lucas Hubert Bernard, Slooff, Thomas Johannes Josephus Hubertus, Schreurs, Berend Willem
• Granted Patent: US 8,361,161 B2
• Time in Patent Office: Days
• US Class Current: 606/93
• 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 parts, comprising:

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

metal granules having an internal porosity;

bone cement.

2. 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 at least one time the average size of the granules, preferably between 1 and 10 times and more preferably between 1 and 4 times.

3. Kit of parts according to claim 2, wherein the amount of 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, preferably 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.

4. Kit of parts according to claim 3, wherein said amount of cement is sufficient to fill pores of said granules and openings between said granules up to an average of at least one third of said layer of granules.

5. Kit of parts according to any one of 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.

6. Kit of parts according to claim 5, wherein said mesh is such that said granules can be contained by said mesh.

7. Kit of parts according to any one of the preceding claims, further comprising means for compacting said granules in an opening in a bone.

8. Kit of parts according to claim 7, wherein said compacting means is provided with a contact part having a configuration similar and preferably substantially identical to a part of said prosthesis, especially said at least one contact surface to be introduced into said opening.

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

10. 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, more specifically between 2.5 and 7 mm.

11. Kit of parts according to claim 10, wherein substantially all of said granules have an average size between 1 and 10 mm, more specifically between 2.5 and 7 mm.

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

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

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

16. Kit of parts according to claim 15, wherein said coating has an average thickness of 0.5 to 100 micrometer, especially a coating containing calcium phosphate.

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

18. Kit of parts according to claim 1, wherein said bone cement is chosen from the group of acrylates such as polymethyl-methacrylate (PMMA)

19. 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 from the group of osteoconductive or osteoinductive coatings, or coatings comprising bioceramic, bioglass or osteoconductive or osteoinductive molecules or fluids or cells.

34. Kit of parts, according to claim 1, 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, preferably an end portion, tapering in a direction facing away from said impact surface.

14. Kit of parts, wherein said granules have been formed using a method of purification of titanium with titanium tetrachloride (TiCl₄)

20. Method for fixating a prosthesis or part thereof, in vivo or in vitro, in a bone or an artificial bone, comprising the steps of:

preparing an opening in a bone for receiving at least one contact surface of a prosthesis;

filling said opening and/or encountered osseous defects at least partly with metal granules having an internal porosity, such that substantially an entire inner wall of said opening is covered with a layer of said granules;

introducing a compacting device into said granules within an aperture in said layer and compacting said layer of granules against said inner wall, such that upon retraction of said compacting device from said aperture, said aperture has substantially the shape and dimensions of the at least one contact surface of said prosthesis;

introducing bone cement and said at least one body contact surface into said aperture, such that said bone cement is forced into said layer of granules, into and between part of said granules;

such that when said at least one contact surface is in a desired position for fixation the space between said at least one contact surface and the inner wall is filled with said layer of granules and the bone cement is forced into said layer.

21. Method according to claim 20, wherein said cement is forced into and between said granules to an average depth of no more than two-third of the average thickness of said layer, seen from the at least one body contact surface.

22. Method according to claim 20, wherein said cement is forced into and between said granules to an average depth of no more than 1 centimetre, seen from the at least one contact surface, preferably less than 7.5 mm.

23. Method according to any one of claim 20, wherein prior to introduction into said opening the granules are soaked in a fluid, especially a fluid comprising or existing of water.

24. Method according to claim 23, wherein during compacting of the granules at least part and preferably more than 50% of the fluid is forced out of and from between said granules.

25. Method according to claim 20, wherein, wherein a mesh is provided in said opening, prior to or following introduction of at least part of said layer of granules.

26. Method according to claim 20, wherein prior to preparing said opening for receiving said at least one body contact surface a prosthesis is removed from said bone, leaving said opening, after which the inner wall of said opening is cleaned, prior to introduction of said granules.

27. Method according to claim 20, wherein compacting is achieved using multiple compacting devices.

28. Method according to claim 20, wherein the granules are compacted against said inner wall with at least 25%.

29. Method according to claim 20, wherein voids or openings in said inner wall are filled with granules, before or during providing said layer of granules.

30. Use of metal, porous granules and bone cement in the preparation of a kit of parts for fixating a prosthesis in bone.

31. Use of metal, porous granules in the preparation of elements for filling osseous defects.

32. Kit of parts comprising porous metal granules and a compacting device for preparing elements for filling osseous defects or fixating a prosthesis or part thereof in a bone.

33. Kit of parts according to claim 32, wherein said granules have been soaked in a fluid, especially a fluid containing or existing of water.

35. Method for coating granules of a kit of parts using at least one of:

biomimetic coating, coating in a supersaturated solution;

plasma spray coating;

or

electrochemical deposition, preferably using a salt solution bath or electro spray deposition.