Surface for use on an implantable device

• US 6,193,762 B1
• Filed: 06/02/1999
• Issued: 02/27/2001
• Est. Priority Date: 06/17/1991
• Status: Expired due to Fees

• Current Assignee: Cycam, Inc. (Integer Holdings Corporation Inc), Tech Met, Inc.
• Original Assignee: Cycam, Inc. (Integer Holdings Corporation Inc), Tech Met, Inc.
• Inventors: Reed, Gary, Wagner, Donald J.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US09/324,695
• Time in Patent Office: 636 Days
• Field of Search: 204/224, 204/151, 438/924, 438/694, 205/653-656, 623/920, 623/11.11, 623/66, 427/2
• US Class Current: 623/66.1
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2002/30719 Means for cleaning prostheses
• CPC Class Codes: A61F 2002/30838 Microstructures
• CPC Class Codes: A61F 2002/30906 shot- sand- or grit-blasted
• CPC Class Codes: A61F 2002/30925 etched
• CPC Class Codes: A61F 2250/0092 Means for cleaning prostheses
• 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 2310/00796 Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/32 Phosphorus-containing materials, e.g. apatite
• 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: C09J 2400/166 in the pretreated surface to be joined
• CPC Class Codes: C09J 5/02 involving pretreatment of the surfaces to be joined
• CPC Class Codes: C23F 1/02 Local etching
• CPC Class Codes: C23F 1/04 Chemical milling
• CPC Class Codes: H05K 3/382 : by special treatment of the metal
• CPC Class Codes: H05K 3/44 : Manufacturing insulated metal core circuits or other insulated electrically conductive core circuits H05K3/0058, H05K3/4608, and H05K3/4641 take precedence
• CPC Class Codes: Y10S 623/901 : Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/92 : Method or apparatus for preparing or treating prosthetic
• CPC Class Codes: Y10T 428/24355 : Continuous and nonuniform or irregular surface on layer or component [e.g., roofing, etc.]

Abstract

An attachment surface for an implantable device has a random irregular pattern formed through a repetitive masking and chemical milling process. Additionally, an attachment surface for an implantable device has a random irregular pattern formed through a repetitive masking and electrochemical milling process. The electrochemical milling process is particularly well suited for use with substrate materials which have high chemical inertness which makes them resistant to chemical etching. Surface material is removed from the implant surface without stress on the adjoining material and the process provides fully dimensional fillet radii at the base of the surface irregularities. This irregular surface is adapted to receive the ingrowth of bone material and to provide a strong anchor for that bone material. The unitary nature of the substrate and surface features provides a strong anchoring surface with is resistant to cracking or breaking. The surface is prepared through an etching process which utilizes the random application of a maskant and subsequent etching of the metallic substrate in areas unprotected by the maskant. This chemical etching process is repeated a number of times as necessitated by the nature of the irregularities required in the surface. The etching characteristics are controlled by the time, temperature and number of repetitions utilized in the etching process.

Claims

1. An irregular exterior surface portion on a substrate material which is particularly adapted to be joined to a second material, the surface portion to be so joined comprising a plurality of randomly sized and spaced protrusions located upon said surface portion, produced by the method comprising the steps of:

a) masking said surface portion in a random pattern with a maskant material, such that less than the entire surface portion is covered thereby;

b) electrochemically etching said surface portion such that said substrate material is removed thereby in areas uncovered by said maskant material, and areas covered by said maskant material are left intact;

c) removing said maskant material; and

d) repeating said masking, electrochemically etching and removing steps upon said surface portion until a desired surface irregularity is achieved.

2. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, further comprising the additional preparatory step of cleaning said surface portion.

3. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 2, wherein said cleaning step is accomplished by impinging small solid particles on said surface portion.

4. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 3, wherein said small solid particles are one of aluminum oxide particles and glass beads.

5. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 2, wherein said cleaning step utilizes acetone as a cleanig agent.

6. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 5, wherein said cleaning step utilizes acetone and the impinging of small solid particles.

7. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, further comprising the additional step, following said masking step, of partially abrading the applied maskant by impinging small solid particles thereon.

8. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 7, wherein said small solid particles are one of aluminum oxide and glass beads.

9. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said maskant material is soluble in an alkaline solution.

10. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 9, wherein said maskant material comprises a phenol-formaldehyde resin.

11. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, her comp rising the additional step, after said masking step, of drying the maskant material at an elevated temperature.

12. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 11, said drying step occurring at about 200-250°

F. for a time of at least about 20 minutes.

13. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said removing step utilizes a mechanical abrasive technique for removal of the maskant material.

14. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 13, wherein said maskant material is removed by completely abrading the maskant material by impinging small solid particles thereon.

15. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said removing step is accomplished utilizing a chemical agent.

16. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 15, wherein said chemical agent is an alkaine solution.

17. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said electrochemical etching step is performed to achieve an etch level range of about 0.001-0.010 inches.

18. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 17, wherein said electrochemical etching step is performed to achieve an etch level range of about 0.002-0.007 inches.

19. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said maskant material has a viscosity of about 60-66 seconds as measured on a No. 5 Zahn cup.

20. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said electrochemical etching step further comprises using conformal tooling and using a substantially uniform work gap between said conformal tooling and said surface portion.

21. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 20, wherein said work gap is between about 0.020-0.250 inches.

22. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 21, wherein said work gap is between about 0.060-0.120 inches.

23. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 20, wherein there is a voltage difference between said conformal tooling and said surface portion, said voltage difference being about 8-24 Volts DC.

24. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 23, wherein said voltage difference is about 12-18 Volts DC.

25. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 20, further comprising using an electrolyte fluid in said work gap.

26. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 25, wherein said electrolyte fluid comprises a solution of water, NaCl, and NaNO₃.

27. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 25, wherein said electrolyte fluid has a flow rate, said flow rate being between about 0.15-0.50 gallons per minute per 100 amperes.

28. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 25, said electrolyte fluid having a temperature of between about 100-130°

F.

29. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said electrochemical etching step includes using an electric current, said electric current having a specific amperage of at least about 50 amperes per square inch of said surface area uncovered by said maskant material.

30. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 29, wherein said electric current has a specific amperage of between about 75-125 amperes per square inch of said surface area uncovered by said maskant material.

31. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said substrate material is constructed from an alloy containing cobalt and chromium.

32. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said substrate material is constructed from a cobalt-28 chromium-6 molybdenum alloy.

33. An irregular exterior surface portion on a substrate material, produced by the method as described in claim 1, wherein said substrate material is a bone implant which is adapted for use in the human body.