Methods for Improving Fatigue Performance of Implants With Osteointegrating Coatings

• US 20080221681A1
• Filed: 03/09/2007
• Published: 09/11/2008
• Est. Priority Date: 03/09/2007
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai H., Bono, Frank
• Application Number:
  US11/684,467
• Publication Number:
  US 20080221681A1
• Time in Patent Office: Days
• US Class Current: 623/11.11
• CPC Class Codes: A61B 17/7001 Screws or hooks combined with longitudinal elements which do not contact vertebrae A61B17/7058 takes precedence
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/866 Material or manufacture
• 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 2/32 for the hip
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3804 for elbows
• CPC Class Codes: A61F 2/40 for shoulders
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2/4225 for feet, e.g. toes
• CPC Class Codes: A61F 2/4241 for hands, e.g. fingers
• CPC Class Codes: A61F 2/4261 for wrists
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/4425 : made of articulated components
• CPC Class Codes: A61F 2/4455 : for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2002/30322 : differing in surface structures
• CPC Class Codes: A61F 2002/30906 : shot- sand- or grit-blasted
• CPC Class Codes: A61F 2002/30922 : Hardened surfaces
• CPC Class Codes: A61F 2002/30925 : etched
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2250/0026 : differing in surface structures
• CPC Class Codes: A61F 2310/00395 : Coating or prosthesis-covering structure made of metals or of alloys
• 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: A61F 2310/00958 : Coating or prosthesis-covering structure made of bone or of bony tissue
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61F 2310/00982 : Coating made of collagen
• CPC Class Codes: A61L 27/32 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: B24C 1/06 : for producing matt surfaces, e.g. on plastic materials, on glass
• CPC Class Codes: B24C 1/10 : for compacting surfaces, e.g. shot-peening for deforming sheet metal, tubes or profiles B21D31/06; as a metallurgical treatment C21D7/00, C22F1/00
• CPC Class Codes: C21D 10/005 : by laser shock processing
• CPC Class Codes: C22F 1/183 : of titanium or alloys based thereon
• 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
• CPC Class Codes: C23C 4/02 : Pretreatment of the material to be coated, e.g. for coating on selected surface areas
• CPC Class Codes: C23C 4/18 : After-treatment
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture

Abstract

A method which may be used for introducing a residual compressive stress into a body portion of an implantable device configured for implantation in a patient. The body portion may include an outer surface. The method also may include texturing the outer surface of the implantable device to increase a roughness of the outer surface. The outer surface may be coated with an osteointegrating material to increase osteointegration.

Claims

1. A method comprising:

introducing a residual compressive stress into a body portion of an implantable device configured for implantation in a patient, the body portion including an outer surface;

texturing the outer surface of the implantable device to increase a roughness of the outer surface; and

coating the outer surface with an osteointegrating material to increase osteointegration.

2. The method of claim 1, wherein the coating the outer surface with a osteointegrating material comprises at least one of:

applying a coating of an osteoconductive material on the outer surface; and

applying a coating of an osteoinductive material on the outer surface.

3. The method of claim 1, wherein the coating the outer surface includes coating with a single osteointegrating coating comprising a mixture of osteoconductive and osteoinductive material.

4. The method of claim 1, wherein the coating the outer surface includes one of:

thermal spraying;

plasma depositing;

vapor depositing;

electroplating;

non-thermal spraying;

applying a paste;

dip-coating, and immersing in a solution.

5. The method of claim 1, wherein the coating the outer surface includes applying a coating of hydroxyapatite.

6. The method of claim 5, wherein the coating the outer surface further comprises:

soaking the outer surface of the implantable device in a solution containing osteointegrating material such that molecules of the solution bonds with the hydroxyapatite coating.

7. The method of claim 1, wherein coating the outer surface includes coating less than all of a bone engaging portion of the outer surface.

8. The method of claim 1, wherein the coating the outer surface includes applying osteointegrating material to a section of the outer surface.

9. The method of claim 1, wherein the coating the outer surface includes applying an osteoconductive material comprising at least one of:

hydroxyapatite;

a biocompatible ceramic;

a calcium sulfate;

a calcium phosphate;

corraline hydroxyapatite;

biphasic calcium phosphate;

tricalcium phosphate;

fluorapatite;

mineralized collagen;

bioactive glasses;

porous metals;

bone particles;

demineralized bone matrix (DBM); and

combinations thereof.

10. The method of claim 1, wherein the coating the outer surface includes applying an osteoinductive material comprising at least one of:

bone morphogenetic proteins;

demineralized bone matrix;

transforming growth factors;

osteoblast cells;

growth and differentiation factors;

insulin-like growth factor 1;

platelet-derived growth factor;

fibroblast growth factor; and

combinations thereof.

11. The method of claim 1, wherein the introducing a residual compressive stress is performed until the compressive stress is at a first depth in the body portion, and wherein texturing the outer surface is performed until the texturing is at a second depth in the body portion, and wherein the second depth is less than the first depth.

12. The method of claim 1, wherein the introducing a residual compressive stress comprises work-hardening the body portion of the implantable device.

13. The method of claim 12, wherein the work-hardening includes one of:

a forging process;

a pressurization process;

a water jet process;

a drawing process;

cold rolling;

drawing;

deep drawing;

pressing;

bending;

cold forging;

cold extrusion;

hammering;

shearing; and

peening.

14. The method of claim 1, wherein the texturing includes one of:

chemical etching;

electrical etching;

sanding;

electrical discharge;

machining;

grit-blasting;

abrading;

plasma etching; and

embedding particles.

15. A method of treating an implantable device including a body portion with an outer surface to maintain fatigue resistance properties comprising:

peening the outer surface of the body portion of the implantable device to introduce a residual compressive stress into the body portion, the residual compressive stress having a first depth;

texturing the peened outer surface of the body portion to increase a surface roughness of the outer surface, the texturing having a second depth into the body portion; and

coating the outer surface of the body portion with an osteointegrating material to promote osteointegration.

16. The method of claim 15, wherein the second depth is less than the first depth.

17. The method of claim 15, wherein coating the outer surface with an osteointegrating material comprises at least one of:

applying a coating of an osteoconductive material on the outer surface; and

applying a coating of an osteoinductive material on the outer surface.

18. The method of claim 15, wherein the coating the outer surface includes coating with a single osteointegrating coating comprising a mixture of osteoconductive and osteoinductive material.

19. The method of claim 15, wherein the coating the outer surface includes one of:

thermal spraying;

plasma depositing;

vapor depositing;

electroplating;

non-thermal spraying;

applying a paste;

dip-coating; and

immersing in a solution.

20. An implantable device, comprising:

a body portion having an outer surface and a thickness, wherein the body portion has a residual compressive stress extending to a first depth,

wherein the outer surface has a roughened texture, the roughened texture penetrating the outer surface of the body portion to a second depth, the second depth being less than the first depth; and

an osteointegrating coating disposed on the outer surface and engaged with the roughened texture.

21. The implantable device of claim 20, wherein the osteointegrating coating comprises at least one of:

a coating of an osteoconductive material on the outer surface; and

a coating of an osteoinductive material on the outer surface.

22. The implantable device of claim 20, wherein the osteointegrating coating includes a mixture of osteoconductive and osteoinductive material.

23. The implantable device of claim 22, wherein the osteoinductive material is disposed within pores of the osteoconductive material.

24. The implantable device of claim 20, wherein the osteointegrating coating is disposed on a section of the outer surface.

25. The implantable device of claim 20, wherein the body portion is one of:

an implantable artificial disc;

a facet joint replacement implant;

an interspinous spacer;

an intervertebral spacer;

a bone plate;

a bone screw;

a bone anchor;

a bone fastener;

a fenestrated screw;

a corpectomy device;

an intramedulary rod;

a hip joint replacement implant;

a bone pin or rod;

a knee joint replacement implant;

a shoulder joint replacement implant;

an elbow joint replacement implant;

a wrist joint replacement implant;

an ankle joint replacement implant;

a finger joint replacement implant;

a toe joint replacement implant;

a dental implant; and

a maxillofacial/cranial implant.

26. The implantable device of claim 20, wherein the coating includes an osteoconductive material comprising at least one of:

hydroxyapatite;

a biocompatible ceramic;

a calcium sulfate;

a calcium phosphate;

corraline hydroxyapatite;

biphasic calcium phosphate;

tricalcium phosphate;

fluorapatite;

mineralized collagen;

bioactive glasses;

porous metals;

bone particles;

demineralized bone matrix (DBM); and

combinations thereof.

27. The implantable device of claim 20, wherein the coating includes an osteoinductive material comprising at least one of:

bone morphogenetic proteins;

demineralized bone matrix;

transforming growth factors;

osteoblast cells;

growth and differentiation factors;

insulin-like growth factor 1;

platelet-derived growth factor;

fibroblast growth factor; and

combinations thereof.