Composite material bone implant

• US 9,370,388 B2
• Filed: 06/07/2011
• Issued: 06/21/2016
• Est. Priority Date: 06/07/2010
• Status: Active Grant

• Current Assignee: CarboFix Orthopedics Ltd.
• Original Assignee: CarboFix Orthopedics Ltd.
• Inventors: Globerman, Oren, Beyar, Mordechay, Einav, Elad, Wachsler-Avrahami, Hila
• Primary Examiner(s): Beccia, Christopher
• Application Number:
  US13/702,334
• Publication Number:
  US 20130079829A1
• Time in Patent Office: 1,841 Days
• Field of Search: 606/70, 606/71, 606280-331, 606 96- 98
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1717 for applying intramedullary nails or pins
• CPC Class Codes: A61B 17/1728 for holes for bone plates or plate screws
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• 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 17/8052 immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
• CPC Class Codes: A61B 17/862 at the periphery of the screw head
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/863 with thread interrupted or changing its form along shank, other than constant taper
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 17/8685 comprising multiple separate parts
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61B 17/8863 Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2210/00 Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof

Abstract

Radiolucent composite implants. Some embodiments include reconfiguration indicators. Some embodiments include radio-opaque markers, especially along contours. Some embodiments are provided in kit form with accessories such as radiolucent drill guides and/or drives. Some embodiments have fiber reinforcement adapted for various usage scenarios. Some embodiments include metal components, for example, to increase strength. Also described are manufacturing methods.

Claims

1. A bone implant kit comprising:

a bone-supporting component formed mainly of a fiber-reinforced polymer composite, in the form of a radiolucent bone plate with a plurality of locations designated for attaching a fixation component therethrough;

one or more fixation components for the bone-supporting component; and

a radiolucent drill guide defining an array of holes, said drill guide configured to be directly mounted on said bone plate such that said array of holes is aligned with and adjacent to said plurality of locations of said bone plate to facilitate drilling for insertion of the fixation components;

wherein said bone-supporting component and said drill guide, when mounted on said bone-supporting component to form an assembly, are radiolucent enough to allow imaging of the bone through said assembly using x-rays.

2. A bone implant kit according to claim 1, wherein the bone-supporting component includes pre-drilled passages for the fixation components so that only the bone needs to be drilled during the implantation procedure.

3. A bone implant kit combination according to claim 2, wherein the bone-supporting component is supplied with at least one undrilled hole, and both the bone and passages for the fixation components are drilled during the implantation procedure.

4. A bone implant kit according to claim 1, further including an arrangement for removing drilling debris created by drilling for insertion of a bone implant comprising a suction element configured for connection to a source of suction and for disposal of a suction port on the suction element adjacent to a drill bit during drilling.

5. A bone implant kit according to claim 1, further including an arrangement providing irrigation fluid to a drilling site comprising an irrigation element configured for connection to a source of irrigation fluid,

wherein the irrigation element includes a fluid outlet port configured to be positioned adjacent to a drill bit during drilling.

6. A kit according to claim 1, comprising a screw for attaching said drill guide to a hole in said plate.

7. A kit according to claim 1, wherein said drill guide comprises a pin which mounts in a hole in said plate.

8. A kit according to claim 1, wherein said drill guide is provided in kit form pre-attached on said plate.

9. A kit according to claim 1, wherein said bone plate has a head and a stem and wherein said drill guide is configured for guiding drilling into holes in said head.

10. A kit according to claim 1, wherein said drill guide defines at least one hole that is oblique to said plate.

11. A kit according to claim 1, comprising at least one drill sleeve adapted to mount on any of a plurality of holes in said plate or in any of a plurality of holes in said drill guide.

12. A kit according to claim 11, wherein said drill sleeve includes a shoulder which prevents over penetration thereof into said plate.

13. A kit according to claim 11, wherein said drill sleeve is dimensioned to friction fit in a holes of said plate or a hole of said drill guide.

14. A kit according to claim 11, comprising a k-wire sleeve.

15. A kit according to claim 11, comprising an insertion sleeve for guiding the insertion of a fixation device into said hole.

16. A kit according to claim 15, wherein said insertion sleeve and said drill sleeve are adapted to be connected together.

17. A kit according to claim 1, wherein said locations comprise unthreaded holes.

24. A kit according to claim 6, wherein said screw is held in place by a thread.

25. A kit according to claim 1, wherein a contour of said drill guide matches a contour of said bone plate to provide for introducing said drill guide and bone plate into the body together.

18. A method of treating a bone fracture comprising:

positioning a bone-supporting component in the form of a bone plate at a desired position in relation to a fracture site,

wherein the bone-supporting component is formed of a fiber-reinforced polymer composite manufactured with pre-drilled passages for receiving fixation components;

providing a radiolucent drill guide with an array of holes directly mounted on said bone plate such that said array of holes is aligned with and adjacent to said passageways;

imaging the bone through said bone supporting component and said drill guide using x-rays; and

aiming, using said x-rays so acquired, a k-wire or drilling through said drill guide and said bone.

19. A method according to claim 18, wherein the drilling is performed using a radiolucent drill.

20. A method according to claim 18, comprising manipulating bone fragments after said positioning while viewing said bone fragments through said component.

21. A method according to claim 18, wherein said drilling comprises drilling through a sleeve attached to said plate or said drill guide.

22. A method according to claim 18, comprising guiding a fixation component to said bone a sleeve attached to said plate or said drill guide.

23. A method according to claim 18, comprising assembling a plurality of guide sleeves together and mounting on said drill guide.

26. A method according to claim 18, wherein said providing a radiolucent drill guide comprises introducing said drill guide into the body to the fracture site.