Composite material bone implant

• US 10,028,777 B2
• Filed: 07/29/2015
• Issued: 07/24/2018
• Est. Priority Date: 01/16/2009
• Status: Active Grant

• Current Assignee: CarboFix Orthopedics Ltd.
• Original Assignee: CarboFix Orthopedics Ltd.
• Inventors: Beyar, Mordechay, Globerman, Oren, Einav, Elad, Wachsler-Avrahami, Hila
• Primary Examiner(s): Beccia, Christopher
• Application Number:
  US14/811,859
• Publication Number:
  US 20150327893A1
• Time in Patent Office: 1,091 Days
• CPC Class Codes: A61B 17/1631 Special drive shafts, e.g. flexible shafts A61B17/1642, A61B17/164 take precedence
• CPC Class Codes: A61B 17/1725 for applying transverse screws or pins through intramedullary nails or pins
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7208 Flexible pins, e.g. ENDER pins
• CPC Class Codes: A61B 17/7225 for bone compression
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 17/7241 the nail having separate elements through which screws pass
• CPC Class Codes: A61B 17/744 the longitudinal elements coupled to an intramedullary nail
• 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 17/8052 immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence
• CPC Class Codes: A61B 17/92 Impactors or extractors, e.g. for removing intramedullary devices insertion or extraction of artificial joints A61F2/4603
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A composite bone implant. In some embodiments, one or more features are provided, such as markers for passageways, axial engagement of bone screws, sliding support of bone screws and/or a cannulated channel for a guide wire.

Claims

1. A bone implant comprising:

a fiber reinforced polymer matrix elongate body;

a passage through the body, open at opposite ends, and configured to receive a bone fixation screw; and

markings radiopaque to x-rays at opposite ends of the passage defining the location and orientation of the passage;

said markings formed to appear as single dots under fluoroscopic imaging only when viewed from a lateral side of said elongate body in a direction along said passage, said direction suitable for insertion of said bone fixation screw into said passage, for providing said orientation.

2. A bone implant according to claim 1, wherein the passage is near a distal end or a proximal end of the body.

3. A bone implant according to claim 1, wherein the radiopaque markings are comprised of a plurality of localized areas of radiopaque material around the outside of the passage.

4. A bone implant according to claim 1, further comprising a radiopaque marking defined by a metal element extending along a longitudinal axis of the body.

5. A bone implant according to claim 1, wherein the body is cannulated and further includes a radiopaque marking defined by a metal layer extending along an inner surface of a lumen running through the implant body.

6. A bone implant according to claim 3, wherein the localized areas are diametrically opposed, and are equally spaced from a longitudinal axis of the respective passages, whereby correct orientation for insertion of the fixation screw into the passage is indicated when said markings at opposite ends of the passage appear as said single dots under radiographic imaging.

7. The bone implant of claim 3, wherein the plurality of localized areas of radiopaque material comprises at least two localized areas around the passage at each opposite end of the passage.

8. A bone implant according to claim 1, wherein the radiopaque markings comprise tantalum.

9. A bone implant according to claim 1 formed as an intramedullary nail, wherein said body comprises:

a core constructed and configured to resist mainly bending loads, said core comprised of substantially linearly extending long carbon fibers in a polymer matrix; and

a portion enclosing the core constructed and configured to resist mainly torsional loads, comprised of multiple layers of carbon fibers in a polymer matrix helically wound in opposite directions.

10. A bone implant according to claim 9, wherein at least part of an exterior surface of said core is covered with a layer of metal.

11. A bone implant according to claim 10, wherein the metal coating on the exterior surface of said core is titanium.

12. A bone implant according to claim 9, wherein the enclosing portion is comprised of two layers of filaments helically wound in opposite directions.

13. A bone implant according to claim 9, further including a further layer comprised of linearly extending filaments covering at least part of the portion enclosing the core.

14. A bone implant according to claim 13, wherein a proximal end is comprised of a core of linearly extending filaments;

at least two layers of filaments helically wound in opposite directions; and

a further layer comprised of filaments in a circular spiral configuration.

15. A bone implant according to claim 9, wherein the helically wound carbon fibers lie at about +45 degrees and −

45 degrees to a longitudinal axis of the nail.

16. A bone implant according to claim 9, wherein the nail includes a radiopaque marker at least along part of its length.

17. A bone implant according to claim 1, wherein the radiopaque markings are formed as two short rods located at opposite ends of the passage, aligned with and parallel to an axis of said passage.

19. A bone implant according to claim 1, wherein said passage extends along a passage axis which is transverse to a long axis of said elongate body.

20. A bone implant according to claim 1, wherein said bone implant is formed as an intramedullary nail.

18. A method of aligning a bone implant comprising:

providing bone implant comprising a fiber reinforced polymer matrix elongate body having a passage through the body, open at opposite ends, and configured to receive a bone fixation screw; and

orientating markings radiopaque to x-rays and located at opposite ends of the passage such that the markings appear as a single dot under fluoroscopic imaging only when viewed from a lateral side of said elongate body in a direction along said passage, said direction suitable for insertion of said bone fixation screw into said passage.