NUCLEUS ANTI-EXPULSION DEVICES AND METHODS

• US 20080097611A1
• Filed: 09/26/2006
• Published: 04/24/2008
• Est. Priority Date: 09/26/2006
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Spine Incorporated (Johnson & Johnson)
• Inventors: Stad, Shawn D., Mastrorio, Brooke W., Hall, Mark T.
• Granted Patent: US 8,900,306 B2
• Time in Patent Office: Days
• US Class Current: 623/17.16
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30136 undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
• CPC Class Codes: A61F 2002/30166 H-shaped or I-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30471 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30477 using sharp protrusions, e.g. spikes, for anchoring into connecting prosthetic part
• CPC Class Codes: A61F 2002/30565 having spring elements
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/4435 Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4495 having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0028 : Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

Devices and methods for preventing the migration or expulsion of a nucleus disc replacement implant are provided. In one embodiment, an anti-expulsion device includes a body that is movable between a compressed configuration where it is adapted to fit through an opening in an annulus of a spinal disc, and an expanded configuration where it has a size that is larger than a size of the opening in the annulus of a spinal disc. The body can also include one or more mating features that allow the body to interact with a nucleus disc replacement implant and/or an annular wall of an annulus. As a result, since the body is larger than the opening of the annulus in the expanded configuration, the interlocking connection between the body and the nucleus disc replacement implant and/or annular wall will allow the body to prevent the nucleus disc replacement implant from being expulsed from the opening in the annulus.

Claims

1. An anti-expulsion device, comprising:

a body movable between a compressed configuration in which the body is adapted to fit through an opening in an annulus of a spinal disc, and an expanded configuration in which the body has a size larger than a size of the opening in the annulus of the spinal disc, the body including a mating feature adapted to interlock with at least one of a nucleus disc replacement implant and an annulus of a spinal disc such that the body becomes integral with the nucleus disc replacement implant or annulus to prevent expulsion of the nucleus disc replacement implant from the annulus of the spinal disc.

2. The device of claim 1, wherein the body is substantially C-shaped in the expanded configuration with first and second ends.

3. The device of claim 2, wherein the mating feature comprises at least one mating element formed on the first and second ends and adapted to interlock with at least one of a nucleus disc replacement implant and an annulus of a spinal disc.

4. The device of claim 3, wherein the at least one mating element is selected from the group consisting of curls, hooks, undercuts, penetrating legs, staples, coils, barbs, channels, holes, claws, and combinations thereof.

5. The device of claim 2, wherein the body includes at least one bend region that facilitates movement of the body from the compressed configuration to the expanded configuration.

6. The device of claim 5, wherein the bend region is formed at a mid-portion of the body such that the first and second ends move toward one another in the compressed configuration.

7. The device of claim 1, wherein the body is substantially ring-shaped in the expanded configuration, and includes a central opening that is adapted to interlock with a nucleus disc replacement implant.

8. The device of claim 1, wherein the body is substantially spherical and is formed from a mesh material that forms the mating feature.

9. The device of claim 1, wherein the body includes a bioactive tissue regenerative material attached thereto.

10. The device of claim 1, wherein the body is adapted to reinforce an annular wall of an annulus of a spinal disc when the body is in the expanded configuration.

11. The device of claim 1, wherein the mating feature comprises a plug adapted to be positioned within an opening in an annulus, and wherein the body includes legs coupled to the plug and adapted to be disposed within and to engage an inner wall of an annulus.

12. A nucleus disc replacement system, comprising:

a nucleus disc replacement implant; and

an anti-expulsion device having a body movable between a compressed configuration in which the body is adapted to fit through an opening in an annulus of a spinal disc, and an expanded configuration in which the body has a size larger than a size of an opening in an annulus of a spinal disc, the body being adapted to interlock with at least one of the nucleus disc replacement implant and an annulus of a spinal disc to prevent expulsion of the nucleus disc replacement implant through an annulus of a spinal disc.

13. The system of claim 12, wherein the body has a configuration selected from the group consisting of C-shaped, ring-shaped, kidney-bean shaped, and substantially spherical.

14. The system of claim 12, wherein the body of the anti-expulsion device includes at least one mating element for interlocking with the nucleus disc replacement implant.

15. The system of claim 14, wherein the mating element is selected from the group consisting of curls, hooks, undercuts, penetrating legs, staples, coils, barbs, channels, holes, claws, and combinations thereof.

16. The system of claim 14, wherein the mating element is a mesh material.

17. The system of claim 12, wherein the body includes opposed legs movable between the compressed and expanded configurations, and a plug coupled to the legs and adapted to be positioned within an opening in an annulus to interlock with the annulus.

18. The system of claim 12, wherein at least a portion of the body includes a bend region that is adapted to allow the body to move from the compressed configuration to the expanded configuration.

19. The system of claim 18, wherein the bend region is formed at a mid-portion of the body such that a first end of the body is moved toward a second end of the body when in the compressed configuration.

20. The system of claim 12, wherein the body includes a tissue regenerative material attached thereto.

21. The system of claim 12, wherein the body is adapted to reinforce an annular wall of an annulus of a spinal disc when the body is in the expanded configuration.

22. A method for implanting a nucleus disc replacement implant, comprising:

inserting an anti-expulsion device through an opening formed in an annulus of a spinal disc to position the anti-expulsion device within a nucleus void formed in a nucleus of the spinal disc, the anti-expulsion device being in a compressed configuration during insertion;

releasing a force on the anti-expulsion device such that it moves from the compressed configuration to an expanded configuration in which the anti-expulsion device has a size greater than a size of the opening in the annulus; and

inserting a nucleus disc replacement implant into the nucleus void, the anti-expulsion device preventing expulsion of the nucleus disc replacement implant through the opening.

23. The method of claim 22, wherein the nucleus disc replacement implant interlocks with the anti-expulsion device.

24. The method of claim 22, wherein the anti-expulsion device interlocks with the annulus.

25. The method of claim 22, wherein the anti-expulsion device is inserted through a cannula that compresses the anti-expulsion device into the compressed configuration, and wherein releasing the force comprises advancing the anti-expulsion device out of the cannula and into the nucleus void.

26. The method of claim 22, wherein the anti-expulsion device is substantially C-shaped with opposed ends that are moved toward one another when the anti-expulsion device is in the compressed configuration, and wherein the ends move away from one another when the force is released and the device moves to the expanded configuration.

27. The method of claim 22, further comprising positioning the anti-expulsion device against the opening in the annulus to act as a reinforcement of an annular wall.

28. The method of claim 22, wherein the anti-expulsion device includes a tissue regenerative material, and the method further comprises positioning the anti-expulsion device against the opening in the annulus such that the tissue regenerative material facilitates regeneration of an annular wall.

29. The method of claim 22, further comprising, prior to inserting the anti-expulsion device, removing at least a portion of a nucleus from a spinal disc to form the nucleus void.