Multi-layer composite material bone screw

• US 10,617,458 B2
• Filed: 12/23/2015
• Issued: 04/14/2020
• Est. Priority Date: 12/23/2015
• Status: Active Grant

• Current Assignee: Carbofix Spine Incorporated
• Original Assignee: CarboFix In Orthopedics LLC (CarboFix Orthopedics Ltd.)
• Inventors: Beyar, Mordechay, Globerman, Oren
• Primary Examiner(s): Bates, David W
• Application Number:
  US14/757,523
• Publication Number:
  US 20170181785A1
• Time in Patent Office: 1,574 Days
• CPC Class Codes: A61B 17/8635 Tips of screws
• 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 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00964 composite
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3991 having specific anchoring means to fixate the marker to the tissue, e.g. hooks
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/125 having a macromolecular matrix
• CPC Class Codes: A61L 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: C08L 71/00 Compositions of polyethers obtained by reactions forming an ether link in the main chain of polyacetals C08L59/00; of epoxy resins C08L63/00; of polythioether-ethers C08L81/02; of polyether-sulfones C08L81/06; Compositions of derivatives of such polymers

Abstract

Composite material screws and construction techniques are described comprising reinforcing fibers directed in different winding directions and/or angles at different layers (radial depths) of the screw. Optionally, the screw comprises composite material layers wound with fibers at both the pitch of the thread of the screw and at a steeper pitch (for example, about 45°). Optionally, an outer layer of the screw comprises a relative radiolucent construction and/or material, with a more radiopaque construction and/or material positioned underneath the outer layer such that at least a portion of the screw outline is delineated by a radioimaging technique (for example, fluoroscopy, CT, or MRI), while maintaining a sufficiently artifact-free image around the screw that the image characteristics of the surrounding tissue are still determinable.

Claims

1. A fiber-reinforced composite material bone screw comprising:

a screw core comprising fiber-reinforced polymer matrix composite material having a first fiber arrangement; and

a thread region circumferentially surrounding the screw core at least along a threaded shaft of the screw, the thread region comprising fiber-reinforced polymer matrix composite material having a second fiber arrangement;

wherein the fibers of the fiber-reinforced polymer matrix composite material of the thread region comprise at least a first fiber population and a second fiber population, wherein at least 10% of the fibers of said first population pass at an angle of at least 10 degrees relative to fibers of said second fiber population;

said at least first and second populations interspersed with each other and within said polymer matrix of the thread region; and

wherein the thread region is formed by compression molding.

2. The bone screw of claim 1, wherein particles of powdered radiopaque marker material are distributed within the polymer matrix of the thread region, said particles of powdered radiopaque marker material arranged circumferentially around at least a portion of the thread region, and beneath a threaded surface of the screw core.

3. The bone screw of claim 2, wherein the radiopaque marker material comprises at least one from the group consisting of gold, platinum, rhenium, tungsten, tantalum, barium sulfate, and/or iodinated compounds.

4. The bone screw of claim 2, wherein the radiopaque marker material is in a powdered form, the particles of the powder being less than 200 μ

m in diameter.

5. The bone screw of claim 2, wherein the radiopaque marker material is at least 10 μ

m from the outer surface of the screw core.

6. The bone screw of claim 2, wherein the radiopaque marker material extends circumferentially around at least 70% of the circumference of the portion of the screw core.

7. The bone screw of claim 2, wherein the radiopaque marker material extends circumferentially entirely around the circumference of the portion of the screw core.

8. The bone screw of claim 2, comprising a metallic outer layer circumferentially surrounding the particles of radiopaque material.

9. The bone screw of claim 8, wherein the material of the metallic outer layer comprises at least one of the group comprising titanium and titanium alloy.

10. The bone screw of claim 9, wherein an inner portion of the metallic outer layer comprises the radiopaque marker material in a sheet form.

11. The bone screw of claim 8, wherein the radiopaque marker material comprises a material having a greater linear attenuation coefficient than the outer material of the metallic outer layer.

12. The bone screw of claim 2, wherein the radiopaque marker material is concentrated along at least one path following a helical path of the thread of the threaded shaft.

13. The bone screw of claim 2, wherein the radiopaque marker material comprises at least one radiopaque region at a screw tip at one end of a longitudinal axis of the bone screw.

14. The bone screw of claim 1, wherein said fibers of said thread region also alternately extend radially inward and outward.

15. The bone screw of claim 1, wherein said fibers of said thread region comprise a substantially continuous distribution of orientations relative to a helical path of said screw, with no gaps of missing orientations wider than about 5°

.

16. The bone screw of claim 1, wherein said fibers of said thread region comprise a substantially continuous distribution of orientations relative to a helical path of said screw through all angles tangential to the screw core.

17. The bone screw of claim 1, wherein said fibers of said thread region comprise a substantially continuous distribution of orientations relative to a helical path of said screw through all angles.

18. The bone screw of claim 1, wherein all fiber orientations within the thread region are about equally represented.

19. The bone screw of claim 1, wherein fibers extending through the thread region also extend through a thread base region comprised of said composite material extending continuously between the thread windings.

20. The bone screw of claim 1, wherein fibers of said first fiber population and said second fiber population are dispersed at various directions with respect to a winding direction of said thread.

21. The bone screw of claim 1, wherein fibers of said thread region comprise a population of fiber lengths passing within the thread region which is substantially omnidirectional at least circumferentially with respect to a helical path of the thread region.

22. The bone screw of claim 2, wherein said particles of powdered radiopaque marker material are included in a layer within the polymer matrix.

23. The bone screw of claim 2, wherein said particles of powdered radiopaque marker material are included in discreet structures within the polymer matrix of said thread region.

24. The bone screw of claim 23, wherein said discreet structures are one of pellets and grains.

25. The bone screw of claim 1, wherein said thread region includes at least one layer of windings of prepreg tape, each layer of windings having substantially the same winding angle.

26. The bone screw of claim 1, wherein at least 10% of the fibers of said first population pass at an angle of less than 90 degrees relative to the fibers of said second fiber population.

27. The bone screw of claim 1, wherein the fiber-reinforced polymer matrix extends between a thread valley and a thread peak.