Composite implant coating

• US 10,045,798 B2
• Filed: 11/11/2013
• Issued: 08/14/2018
• Est. Priority Date: 11/11/2012
• Status: Active Grant

• Current Assignee: Carbofix Spine Incorporated
• Original Assignee: CarboFix Orthopedics Ltd.
• Inventors: Beyar, Mordechay, Globerman, Oren, Shavit, Ronen
• Primary Examiner(s): Sevilla, Christian
• Application Number:
  US14/441,862
• Publication Number:
  US 20150289911A1
• Time in Patent Office: 1,737 Days
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• 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 17/8033 having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 31/082 Inorganic materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/126 containing carbon fillers
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: C08L 71/12 Polyphenylene oxides

Abstract

A coating layer, for example PEEK or titanium foil, shields a bone implant surface from wearing interactions with surfaces of bone and/or other implants. The coating prevents shedding particles which are difficult to distinguish from evidence of potentially dangerous conditions, for example, microorganism contamination and/or degenerating tissue. Methods and structures for securing a coating layer are described. Other uses and implementations of coating layers are described.

Claims

1. An implantable bone plate comprising:

a body of fiber-reinforced polymer composite construction; and

at least one layer configured to cover an exterior facing surface region of said body where the layer contacts bone when implanted;

wherein the layer is made of metal such that the body is shielded from wearing contacts with bone when implanted; and

wherein at least one edge region of said at least one layer is encased by material of said bone plate.

2. An implantable bone plate according to claim 1 wherein said material comprises a portion of said body.

3. An implantable bone plate according to claim 2 wherein said material comprises an extrusion of said body.

4. An implantable bone plate according to claim 3 wherein said extrusion comprises a shank and a head;

the shank being attached at one end to the body, and the head being attached to the other end of the shank;

the head being sized and positioned to interfere with the movement of said at least one layer relative to the body.

5. An implantable bone plate according to claim 3, wherein said extrusion is flanged.

6. An implantable bone plate according to claim 1, wherein said material comprises at least a portion of an at least second layer.

7. An implantable bone plate according to claim 6 wherein said at least second layer overlaps and conforms against at least a portion of said edge region.

8. An implantable bone plate according to claim 1, wherein said material comprises a restraining strip.

9. An implantable bone plate according claim 8 wherein said restraining strip is bonded to said body.

10. An implantable bone plate according to claim 8, wherein said edge region of said layer is held within a recess of said body, said recess being at least partially filled by said restraining strip.

11. An implantable bone plate according to claim 8, wherein said edge region of said layer comprises a portion which is bent and within a recess of said body, said recess being at least partially filled by said restraining strip.

13. An implantable bone plate according to claim 1, wherein at least a portion of said layer is made of titanium.

12. An implantable bone plate comprising:

a body of fiber-reinforced polymer composite construction; and

at least one layer configured to cover an exterior facing surface region of said body where the layer contacts bone when implanted;

wherein the layer is made of metal such that the body is shielded from wearing contacts with bone when implanted;

wherein at least a portion of said body is conformed against an edge surface of said at least one layer; and

wherein said conformed portion comprises a pin.

16. An implantable bone plate according to claim 12, wherein at least a portion of said layer is made of titanium.

14. A method for manufacturing an implantable bone plate comprising:

forming a body of fiber-reinforced polymer composite construction,

preparing at least one metal coating layer for the bone plate, and

compression molding the bone plate together with the prepared at least one metal layer;

such that

the at least one metal coating layer is restrained against the surface of said body;

wherein at least one edge region of the at least one metal coating layer is encased by material of said bone plate; and

wherein said preparing comprises positioning said metal coating layer with respect to a surface of the body shaped and positioned with respect to the body for positioning against bone so that it shields said surface from wearing contacts with bone when implanted.

15. The method of claim 14, wherein said preparing comprises perforating said at least one coating layer.

17. A method for manufacturing an implantable bone plate comprising:

forming a body of fiber-reinforced polymer composite construction,

preparing at least one metal coating layer for the bone plate, and

compression molding the bone plate together with the prepared at least one metal layer;

such that

the at least one metal coating layer is restrained against the surface of said body;

wherein at least a portion of said body is conformed against an edge surface of said at least one layer; and

wherein said conformed portion comprises a pin; and

wherein said preparing comprises positioning said metal coating layer with respect to a surface of the body shaped and positioned with respect to the body for positioning against bone so that it shields said surface from wearing contacts with bone when implanted.

18. The method of claim 17, wherein said preparing comprises perforating said at least one coating layer.