Random surface protrusions on an implantable device

• US 5,507,815 A
• Filed: 12/15/1994
• Issued: 04/16/1996
• Est. Priority Date: 06/17/1991
• Status: Expired due to Term

• Current Assignee: Cycam, Inc. (Integer Holdings Corporation Inc), Titan Spine, LLC
• 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:
  US08/358,045
• Time in Patent Office: 488 Days
• Field of Search: 623/66, 623/901, 623/16, 623/11, 623/12, 623/18, 623/19, 623/20, 623/22, 623/23, 427/2
• US Class Current: 623/23.5
• 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. 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. A bone implant formed of a substrate material and having an exterior surface, a portion of said exterior surface being adapted to be joined to a segment of natural bone within the human body, the surface portion to be so joined comprising a plurality of randomly sized, as defined by height and thickness, and spaced, as defined by proximity therebetween, protrusions, which are unstressed with respect to said surface portion, located upon said surface portion in its entirety, said protrusions being formed of the bone implant substrate material and constructed monolithically therefrom.

2. A bone implant as described in claim 1, wherein said protrusions are generally perpendicular to said surface portion.

3. A bone implant as described in claim 1, wherein said protrusions join said substrate at fully dimensioned filleted radii.

4. A bone implant as described in claim 1, wherein said protrusions are formed in levels.

5. A bone implant as described in claim 4, wherein said levels each comprise a plurality of protrusions which are generally of the same height.

6. A bone implant as described in claim 5, further comprising a minority of protrusions which are of a height intermediate that of said levels.

7. A bone implant as described in claim 1, wherein each of said protrusions has at least one surface feature, said protrusions being distinguished by the varying slope of said at least one surface feature.

8. A bone implant as described in claim 7, wherein each of said protrusions has a plurality of sides of varying slope.

9. A bone implant formed of a substrate material and having an exterior surface, a portion of said exterior surface being adapted to be joined to a segment of natural bone within the human body, the surface portion to be so joined comprising a plurality of randomly sized, as defined by height and thickness, and spaced, as defined by proximity therebetween, protrusions, which are unstressed with respect to said surface portion, located upon said surface portion in its entirety, said protrusions being monolithically formed of the bone implant substrate material and constructed by:

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) etching said surface portion utilizing a chemical agent 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, etching and removing steps until a desired surface irregularity is achieved.

10. A bone implant as described in claim 9, wherein said protrusions are generally perpendicular to said surface portion.

11. A bone implant as described in claim 10, further comprising the additional step of randomly milling said substrate material from said surface portion.

12. A bone implant as described in claim 9, wherein said protrusions join said substrate at fully dimensioned filleted radii.

13. A bone implant as described in claim 12, wherein said random milling imparts no stress to said protrusions.

14. A bone implant as described in claim 9, wherein said protrusions are formed in levels.

15. A bone implant as described in claim 14, wherein said levels each comprise a plurality of protrusions which are generally of the same height.

16. A bone implant as described in claim 15, further comprising a minority of protrusions which are of a height intermediate that of said levels.

17. A bone implant as described in claim 9, wherein said protrusions incorporate a plurality of surface features.

18. A bone implant as described in claim 17, wherein said protrusions are distinguished by differing surface features thereon.

19. A bone implant as described in claim 17, wherein each of said protrusions has at least one surface feature, said protrusions being distinguished by the varying slope of said surface features.

20. A bone implant as described in claim 19, wherein each of said protrusions has a plurality of sides of varying slope.