Composite internal fixators

• US 9,492,210 B2
• Filed: 10/15/2009
• Issued: 11/15/2016
• Est. Priority Date: 10/15/2008
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Rains, James K., Austin, Gene Edward, Rose, John Nmi, Ferrante, Joseph Michael, Gerlach, Darin S., Grusin, Nathaniel Kelley, Janna, Sied W., Faber, Henry B., Gosney, Mark S., Wilson, Darren James
• Primary Examiner(s): PLIONIS, NICHOLAS J
• Application Number:
  US13/124,555
• Publication Number:
  US 20120059376A1
• Time in Patent Office: 2,588 Days
• Field of Search: 606 62- 68
• US Class Current: 1/1
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7216 for bone lengthening or compression A61B17/7258 takes precedence
• CPC Class Codes: A61B 17/7225 for bone compression
• CPC Class Codes: A61B 17/7283 with special cross-section of the 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00415 having power generation near the working tip of the tool
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2090/0436 Shielding
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A multi-layer, fiber-reinforced composite orthopedic fixation device having a design selected based on a desired characteristic of the orthopedic fixation device. The design may be selected according to a model of the device, the model defining design constraints, and the design may comprise a pattern of the fiber angle for each layer. The selection of a design may be analyzed using finite element analysis to determine whether the design will comprise the desired characteristic.

Claims

1. A device comprising:

a. an internal fixator for spanning a fracture, the internal fixator having a plurality of layers, each layer of the plurality of layers including a thermoplastic component and a fiber component and each layer of the plurality of layers having a selected fiber angle pattern, wherein the internal fixator defines a first aperture transverse to a longitudinal axis of the internal fixator, the first aperture having a central axis, and wherein the internal fixator includes one or more radio-opaque markers that extend substantially parallel to the central axis of the first aperture,

b. the selected fiber angle patterns being arranged symmetrically from a first layer to a last layer, and

c. the symmetrical arrangement of fiber angle patterns including at least two layers having generally opposing fiber angle patterns.

2. The device of claim 1, wherein the internal fixator is one of an intramedullary nail and a bone plate.

3. The device of claim 1, wherein, for each layer, the fibers of a layer are generally parallel.

4. The device of claim 1, further comprising a sleeve of an abrasion resistant material.

5. The device of claim 1, further comprising an embedded electronic component.

6. The device of claim 1, wherein selected fiber angle patterns of the layers are selected such that the device exhibits a selected stiffness characteristic.

7. The device of claim 1, further comprising an exterior coating of a thermoplastic material with substantially no fiber component.

8. The device of claim 7, wherein the exterior coating comprises a layer in the form of a tape or tow.

9. The device of claim 1, further comprising a sleeve disposed in an aperture of the internal fixator that is configured to receive a fastener, the sleeve configured to receive the fastener therein.

10. The device of claim 1, wherein the internal fixator is an intramedullary nail, the intramedullary nail comprising a head, a shaft, and a transition region between the head and the shaft.

11. The device of claim 10, wherein the head comprises a greater number of layers than a number of layers of the shaft.

12. The device of claim 10, further comprising a channel along an exterior surface.

13. The device of claim 1, wherein the plurality of layers is a plurality of concentric layers.

14. The device of claim 1, wherein the one or more radio-opaque markers comprise wire segments embedded in the internal fixator.

15. The device of claim 1, wherein the internal fixator comprises at least one radio-opaque marker that extends along the longitudinal axis of the internal fixator at a medial side or a lateral side of the internal fixator.

16. The device of claim 15, wherein the at least one radio-opaque marker comprises (i) a first radio-opaque marker that extends along the medial side of the internal fixator, and (ii) a second radio-opaque marker that extends along the lateral side of the internal fixator.

17. The device of claim 1, wherein the one or more radio-opaque markers comprise multiple radio-opaque markers that are substantially parallel with the central axis, the multiple radio-opaque markers being located on opposite sides of the first aperture.

18. The device of claim 1, wherein the internal fixator includes at least one radio-opaque marker that indicates a location of the first aperture in the internal fixator.

19. A device comprising:

a. an internal fixator for spanning a fracture, the internal fixator having a plurality of layers, each layer of the plurality of layers including a thermoplastic component and a fiber component, and each layer of the plurality of layers having a selected fiber angle pattern, wherein the plurality of layers comprises an inner layer that defines a central cannulation, the internal fixator having a hollow cavity within the central cannulation, and the other layers of the plurality of layers are wrapped about the inner layer, wherein the internal fixator defines a first aperture transverse to a longitudinal axis of the internal fixator, the first aperture having a central axis, and wherein the internal fixator includes one or more radio-opaque markers that extend substantially parallel to the central axis of the first aperture,

b. the selected fiber angle patterns being arranged symmetrically from a first layer to a last layer, and

c. the symmetrical arrangement of fiber angle patterns including at least two layers having generally opposing fiber angle patterns.

20. The device of claim 19, wherein the internal fixator is one of an intramedullary nail and a bone plate.

21. The device of claim 19, wherein the internal fixator comprises at least one radio-opaque marker that extends along the longitudinal axis of the internal fixator.

22. A device comprising:

a. an internal fixator for spanning a fracture, the internal fixator having a plurality of layers, each layer of the plurality of layers including a thermoplastic component and a fiber component, and each layer of the plurality of layers having a selected fiber angle pattern,

b. the selected fiber angle patterns being arranged symmetrically from a first layer to a last layer, and

c. the plurality of layers comprising a tape or tow wrapped around a central longitudinal axis of the internal fixator,

wherein the internal fixator has one or more transverse apertures defined through the fixator, the one or more transverse apertures being formed by the tape or tow being routed around the one or more transverse apertures such that fibers within the tape or tow are continuous in regions adjacent the one or more transverse apertures.

23. The device of claim 22, wherein the symmetrical arrangement comprises:

a pair of first layers wrapped about a longitudinal axis of the internal fixator at a first wrap angle with respect to the longitudinal axis; and

a pair of second layers wrapped about the longitudinal axis at a second wrap angle that is opposite the first wrap angle.

24. The device of claim 23, wherein each of the first layers is spaced apart from a center of the plurality of layers by an equal number of layers, and wherein each of the second layers are spaced apart from the center of the plurality of layers by an equal number of layers.

25. The device of claim 22, wherein the internal fixator has a cross-section in a plane perpendicular to the longitudinal axis, the cross-section being generally U-shaped or generally C-shaped.