Porous material for use as implant, bone replacement and in general as material

• US 8,814,936 B2
• Filed: 06/07/2005
• Issued: 08/26/2014
• Est. Priority Date: 06/07/2004
• Status: Active Grant

• Current Assignee: Boneartis AG
• Original Assignee: Boneartis AG
• Inventors: Draenert, Klaus
• Primary Examiner(s): Shay, Randy
• Application Number:
  US11/570,205
• Publication Number:
  US 20080319547A1
• Time in Patent Office: 3,367 Days
• Field of Search: 623/16.11
• US Class Current: 623/16.11
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30205 conical
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30245 Partial spheres
• CPC Class Codes: A61F 2002/30263 cubical
• CPC Class Codes: A61F 2002/30266 wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30273 pyramidal
• CPC Class Codes: A61F 2002/30276 frustopyramidal
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30291 spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2230/0084 : cubical
• CPC Class Codes: A61F 2230/0086 : Pyramidal, tetrahedral, or wedge-shaped
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 27/44 : having a macromolecular matrix
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges

Abstract

Implants and methods for producing same are described, the implants featuring an adjustable porous shell, the inside being continuously interconnectingly adjustably porous and which can be sintered net shaped; these implants exhibit a high compression stability and show, when being combined with filler materials with or without active agents, different chemical, physical-mechanical, biomechanical or also pharmacological properties. The essential features of the manufacturing process are described in FIG. (1) and comprise expandable shaping elements, deformable elastic tools, the application of defined negative pressures, temperatures during defined application periods in combination with combined materials, which can be separated from each other physically, chemically or mechanically and removed.

Claims

1. A porous implant body formed by application of a negative pressure resulting in said implant body comprising:

an outer shell having a continuous surface the entirety of which is penetrated by pores having a predetermined diameter, and further including an inner structure defining a continuously interconnected cavity system made of hollow sphere-shaped cavities, wherein the implant body is configured such that each of the pores of the outer shell is directly connected to one of the cavities of the cavity system and each such connected pore has a diameter smaller than a maximum diameter of the directly connected cavity of the cavity system.

2. The porous implant body of claim 1, configured such that the outer shell is structured to include at least one of contractions and bulges.

3. The porous implant body of claim 1, configured such that the inner structure corresponds to a cancellous bone.

4. The porous implant body of claim 1, wherein the diameter of each of the pores of the outer shell is smaller than the maximum diameter of the directly connected cavity of the continuously interconnected cavity system in a ratio between 1:

5 to 1;

1.5.

5. The porous implant body of claim 1, having the shape of a porous sphere or a sphere-shaped structure of a size between 0.8 mm and 12 mm in diameter and the cavities of the interconnected cavity system having diameters of between 80 μ

m and 1500 μ

m.

6. The porous implant body of claim 1, wherein the inner structure and the outer shell are constructed from a group of materials consisting of a calcium phosphate, a hydroxyapatite, a calcium carbonate, a calcium-sulfate-composition, an aluminum oxide ceramic, a collagen, a polyaminoacid, an absorbable polymer, an acrylate or derivate thereof, a polymethyl-methacrylate, and a metal, the metal selected from the group consisting of a CoCrMo alloy, titanium, tantalum and alloys thereof.

7. The porous implant body of claim 1, configured such that the cavity system includes a filler material having dampening or reinforcing properties.

8. The porous implant body of claim 7, configured such that the filler material is selected from a group consisting of a poly-amino acid, a polylactide, polyglactine, glycoside, polyacetals, poly-acid amides and polyester.

9. The porous implant body of claim 7 wherein the filler material is selected from the group consisting of an absorbable inorganic material and an absorbable organic material.

10. The porous implant body of claim 1, configured such that at least some cavities are filled with a material, said material comprising an active agent which is released and diffuses over the surface of the outer shell.

11. The porous implant body of claim 1, configured such that said implant body includes at least one of an active agent, consisting of a growth factor, a bone morphogenetic protein or combination thereof.

12. The porous implant body of claim 1, configured such that the continuously interconnected cavity system includes wide and narrow cavities formed therein, and that the cavities are configured to accept filler materials and agents or combinations thereof.

13. The porous implant body of claim 1, wherein the surface of the outer shell has differing porosity, and wherein the inner structure includes at least one of a filler material and an active agent within the continuously interconnected cavity system.

14. The porous implant body of claim 1 and wherein the diameters of the pores of the outer shell are smaller than the maximum diameters of the respective cavities directly connected therewith in a ratio of between 1:

3 and 1;

2.

15. The porous implant body of claim 1, configured such that said implant body includes at least one of a hormone, an immunosuppressive drug, a cytostatic, and an antibiotic and combinations thereof.

16. The porous implant body of claim 1, configured such that said implant body includes an antibiotic.

17. The porous implant body of claim 16, wherein the antibiotic comprises one of Gentamycin, Clindamycin, Streptomycin and other bacteriostatic and bactericide agents.

18. A porous implant body having an outer shell having a continuous surface penetrated by pores having a predetermined diameter, and further including an inner structure comprising a conglomerate of cavities defined by sphere-shaped shells, said cavities forming a continuously interconnected cavity system made of hollow sphere-shaped cavities, wherein the implant body is configured such that each of the pores of the outer shell is directly connected to one of the cavities of the cavity system and each such connected pore has a diameter smaller than a maximum diameter of the directly connected cavity of the cavity system, manufactured by the process comprising:

providing a tool having an inner cavity;

placing shaping elements into the inner cavity of the tool;

adding a liquid mass to the inner cavity of the tool, wherein the liquid mass encompasses the shaping elements and defines the inner structure and the outer shell;

subjecting the inner cavity of the tool to a vacuum;

solidifying the mass by cooling;

removing the shaping elements; and

dehydrating, drying and sintering the mass.

19. A porous implant body formed by the application of a negative pressure resulting in said implant body comprising:

an outer shell having a surface the entirety of which is interrupted by pores across the entire surface, and further including an inner structure defining a continuously interconnected cavity system made of hollow sphere-shaped cavities, wherein the implant body is configured such that each of the pores of the outer shell is directly connected to one of the cavities of the cavity system and each such connected pore has a diameter smaller than a maximum diameter of the directly connected cavity of the cavity system.

20. A method of producing a porous implant body, the method comprising:

providing a tool having an inner cavity;

placing shaping elements into the inner cavity of the tool;

adding a liquid mass to the inner cavity of the tool, the liquid mass encompasses the shaping elements and defines an inner structure and an outer shell of the porous implant body;

subjecting the inner cavity of the tool to a vacuum;

solidifying the mass by cooling and thereby solidifying the inner structure and the outer shell of the porous implant body;

removing the shaping elements to create an outer shell having a continuous surface the entirety of which is penetrated by pores having a predetermined diameter, and further including an inner structure defining an interconnected conglomerate of sphere-shaped cavities within the inner structure and forming pores that interrupt the continuous surface of the outer shell wherein each of the pores in the outer shell is directly connected to one of the cavities of the cavity system and each such connected pore has a diameter smaller than a maximum diameter of the directly connected cavity of the cavity system;

dehydrating the outer shell and the inner structure;

drying the outer shell and the inner structure; and

sintering the outer shell and the inner structure.

21. The method of claim 20, and where providing the tool having an inner cavity comprises:

providing a tool having a deformable mold having the inner cavity.

22. The method of claim 20 and wherein placing shaping elements into the inner cavity of the tool comprises:

placing expandable polystyrene spheres into the inner cavity.

23. The method of claim 22 and wherein a size of the pores in the outer shell can be controlled by subjecting the expandable polystyrene spheres to a selected amount of vacuum which causes the spheres to expand to a desired volume and causes a portion of the sphere against a wall defining the inner cavity which defines the pore size in the outer surface.

24. The method of claim 20 and wherein adding a liquid mass to the inner cavity of the tool comprises:

adding a casting material comprising a solution comprising hydroxyapatite or a solution comprising a tricalciumphosphate or combinations thereof.

25. The method of claim 20 and wherein subjecting the inner cavity of the tool to a vacuum comprises subjecting the inner cavity to a negative pressure of between 150 mbar and 800 mbar.

26. The method of claim 20 and wherein subjecting the inner cavity of the tool to a vacuum comprises subjecting the inner cavity to a negative pressure of between 300 mbar and 500 mbar.

27. The method of claim 20 and wherein solidifying the mass by cooling comprises cooling the mass to a temperature range between 4°

C. and 12°

C.

28. The method of claim 20 and wherein removing the shaping elements comprises:

subjecting the solidified mass to a washing in acetone.

29. The method of claim 20 and wherein dehydrating the outer shell and the inner structure comprises:

washing the outer shell and inner structure in a series of steps utilizing increasing concentrations of acetone.

30. The method of claim 20 wherein drying the outer shell and the inner structure comprises:

placing the outer shell and inner structure in a drying chamber; and

subjecting the drying chamber to a selected vacuum for a selected amount of time.

31. The method of claim 20 and wherein sintering the outer shell and the inner structure comprises:

placing the outer shell and the inner structure in a sintering oven at a temperature of around 1,300°

C. for a selected amount of time.