Composite material bone implant

• US 9,101,417 B2
• Filed: 04/07/2014
• Issued: 08/11/2015
• 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 J
• Application Number:
  US14/246,161
• Publication Number:
  US 20140222001A1
• Time in Patent Office: 491 Days
• Field of Search: 606/62, 606300-331
• US Class Current: 1/1
• 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. An intramedullary nail, comprising:

a cannulated body having a core constructed and configured to resist mainly bending loads, comprising substantially linearly extending long carbon fibers in a polymer matrix;

a portion enclosing the core constructed and configured to resist mainly torsional loads, comprising multiple layers of carbon fibers in a polymer matrix, said fibers helically wound at about +45 degrees and −

45 degrees with respect to a longitudinal axis of the nail;

wherein said core comprises a thickness which is at least 10 times larger than a thickness of said portion enclosing the core.

2. The intramedullary nail according to claim 1, wherein an orientation of said helically wound fibers varies, so that the fibers are oriented at angles ranging between 35-55 degrees with respect to a longitudinal axis.

3. The intramedullary nail according to claim 1, wherein a diameter of a longitudinally extending inner lumen of said cannluated nail ranges between 2-2.9 mm, a diameter of said core comprised of linearly extending fibers ranges between 2.9-7 mm, and a diameter of said portion enclosing the core comprising helically wound filaments ranges between 7-11.6 mm.

4. The intramedullary nail according to claim 1, wherein said carbon fibers are braided to combine two neighbor layers.

5. The intramedullary nail according to claim 1, including a further layer surrounding the enclosing portion, said layer comprising linearly extending filaments.

6. The intramedullary nail according to claim 1, wherein said portion enclosing said core is coated by a layer comprising one or more of titanium and tantalum.

7. The intramedullary nail according to claim 1, wherein a proximal end is comprised of a further layer comprised of filaments in a circular spiral configuration.

8. The intramedullary nail according to claim 1, comprising at least one passage through said body, open at opposite ends, and configured to receive a bone fixation screw.

9. The intramedullary nail according to claim 8, comprising markings radiopaque to x-rays at opposite ends of the passage defining the location and orientation of the passage.

10. The intramedullary nail according to claim 9, wherein the markings are comprised of a plurality of localized areas of radiopaque material around the outside of the passage.

11. The intramedullary nail according to claim 9, wherein said radiopaque markings are in the form of rod-shaped elements located at each end of the passage.

12. The intramedullary nail according to claim 1, wherein a proximal end of said nail comprises a threaded bore.

13. The intramedullary nail according to claim 12, wherein said threaded bore is sized and shaped to receive an insertion tool, said tool comprising complementary external threads.

14. The intramedullary nail according to claim 12, wherein said threaded bore is sized and shaped for receiving an end cap, placed upon completion of the implantation.

15. The intramedullary nail according to claim 1, wherein said body is cannulated by said core comprising a substantially central, axially extending lumen.

16. The intramedullary nail according to claim 1, wherein a cumulative content of substantially linearly extending long carbon fibers of said intramedullary nail is at least two times higher than a cumulative content of said helically wound fibers.

17. The intramedullary nail according to claim 1, wherein a diameter of said core is up to 7.6 mm, and a thickness of said portion enclosing the core is between 0.3 mm and 0.6 mm.