EXPANDING INTERVERTEBRAL DEVICE AND METHODS OF USE

• US 20110004308A1
• Filed: 06/09/2010
• Published: 01/06/2011
• Est. Priority Date: 06/17/2009
• Status: Active Grant

• Current Assignee: Trinity Orthopedics, LLC
• Original Assignee: Trinity Orthopedics, LLC
• Inventors: Marino, James F., Elbanna, Jamil
• Granted Patent: US 8,529,628 B2
• Time in Patent Office: Days
• US Class Current: 623/17.12
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

Disclosed is a spinal stabilization device having a plurality of elongate arms having a distal end portion and a proximal end portion, wherein the elongate arms define an interior volume between the distal end portion and the proximal end portion; at least one limit band coupled circumferentially to one or more of the plurality of elongate arms; and a tensioning element positioned within the interior volume. The plurality of elongate arms can transition from a constrained, delivery configuration that is radially contracted and axially elongated to a relaxed, deployment configuration that is radially expanded and axially shortened.

Claims

1. A spinal stabilization device, the device comprising:

a plurality of elongate arms having a distal end portion and a proximal end portion, wherein the elongate arms define an interior volume between the distal end portion and the proximal end portion;

a limit band coupled circumferentially to the plurality of elongate arms; and

a tensioning element positioned within the interior volume;

wherein the plurality of elongate arms passively transition from a constrained, delivery configuration that is radially contracted and axially elongated to a relaxed, deployment configuration that is radially expanded and axially shortened and configured to be released within an intervertebral disc space.

2. The device of claim 1, wherein the limit band is integral with one or more of the plurality of elongate arms.

3. The device of claim 1, wherein the limit band is a separate unitary element coupled to an outer circumference of the device.

4. The device of claim 1, wherein the limit band is radially contracted when the plurality of elongate arms are in the delivery configuration and the limit band is radially expanded when the plurality of elongate arms are in the deployed configuration.

5. The device of claim 1, wherein the limit band resists splaying of the plurality of arms when in the deployed configuration and the device is under a lateral wall load.

6. The device of claim 1, the tensioning element comprises a linkage rod and a locking end cap.

7. The device of claim 6, wherein the linkage rod comprises a distal end and a proximal end, wherein the distal end of the linkage rod couples to the distal end portion of the elongate arms and the proximal end of the linkage rod couples to the locking end cap.

8. The device of claim 7, wherein the locking end cap is coupled to the proximal end portion of the elongate arms.

9. The device of claim 7, wherein the proximal end of the linkage rod is threaded and couples to complementary threads of the locking end cap.

10. The device of claim 8, wherein the tensioning element locks the distal end portion of the arms and the proximal end portions of the arms when the arms are in the deployed configuration.

11. The device of claim 8, wherein compressive loads directed perpendicular to the elongate arms result in a tensile load on the tensioning element.

12. The device of claim 1, wherein an applied circumferential, inward force urges the plurality of arms into the delivery configuration.

13. The device of claim 1, wherein the interior volume in the deployed configuration comprises a fusiform, tubular, oblong, or spheroid shape.

14. The device of claim 1, wherein the deployed configuration of the plurality of elongate arms comprises a whisk, coil, spring, chain-link, or woven basket shape.

15. The device of claim 1, wherein the interior volume is filled with one or more therapeutic materials.

16. The device of claim 15, wherein the therapeutic materials are selected from the group consisting of bone growth material, bone graft material, bone void filler, cancellous bone graft, cortical bone graft, cancellous bone fragment, cortical bone fragment, osteoconductive material, osteoproliferative material, osteoinductive material, a bone morphogenic cytokine, BMP-2, collagen sponge soaked in bone material, or BMP-2 soaked collagen sponge.

17. The device of claim 15, wherein the tensioning element seals the interior volume at the distal end portion and the proximal end portion.

18. The device of claim 15, wherein the tensioning element radially displaces and distributes the therapeutic material within the interior volume.

19. The device of claim 1, wherein the plurality of elongate arms is comprised of a material selected from the group consisting of nitinol, titanium/nickel alloy, and a polymeric material.

20. The device of claim 1, wherein the plurality of elongate arms have a wall thickness that is non-uniform.

21. The device of claim 1, wherein the plurality of elongate arms have a width that is non-uniform.

22. The device of claim 1, wherein the plurality of elongate arms have a reduced wall thickness where the arms couple to the limit band.

23. The device of claim 1, wherein the plurality of elongate arms have a reduced width where the arms couple to the limit band.

24. The device of claim 1, wherein an external diameter of the device in the constrained, delivery configuration is generally constant.

25. A vertebral interbody fusion system comprising:

an interbody device comprising a plurality of elongate arms having a distal end portion and a proximal end portion, wherein the elongate arms define an interior volume between the distal end portion and the proximal end portion of the interbody device, and at least one limit band coupled circumferentially to one or more of the plurality of elongate arms, the interbody device capable of transitioning from a constrained, delivery configuration that is radially contracted and axially elongated to a relaxed, deployed configuration that is radially expanded and axially shortened;

a tensioning element positioned within the interior volume, the tensioning element comprising a linkage rod and a locking end cap; and

a cannula assembly configured to couple to the interbody device, the cannula assembly comprising a slidable containment sleeve having a lumen sized to contain the interbody device in the delivery configuration, a control sleeve having a distal coupling element that couples to the proximal end portion of the interbody device, and a locking driver element;

wherein the interbody device transitions from the delivery configuration to the deployed configuration upon proximal withdrawal of the containment sleeve.

26. The system of claim 25, wherein the limit band is integral with one or more of the plurality of elongate arms.

27. The system of claim 25, wherein the limit band is a separate unitary element coupled to an outer circumference of the device.

28. The system of claim 25, wherein the limit band is radially contracted when the plurality of elongate arms are in the delivery configuration and the limit band is radially expanded when the plurality of elongate arms are in the deployed configuration.

29. The system of claim 25, wherein the limit band resists splaying of the plurality of arms when in the deployed configuration and the device is under a lateral wall load.

30. The system of claim 29, wherein the linkage rod comprises a distal end and a proximal end, wherein the distal end of the linkage rod couples to the distal end portion of the elongate arms and the proximal end of the linkage rod couples to the locking end cap.

31. The system of claim 30, wherein the locking end cap is coupled to the proximal end portion of the elongate arms.

32. The system of claim 30, wherein the proximal end of the linkage rod is threaded and couples to complementary threads of the locking end cap.

33. The system of claim 31, wherein the tensioning element locks the distal end portion of the arms and the proximal end portions of the arms when the arms are in the deployed configuration.

34. The system of claim 31, wherein compressive loads directed perpendicular to the elongate arms result in a tensile load on the tensioning element.

35. The system of claim 25, wherein the slidable containment sleeve applies a circumferential, inward force upon the plurality of arms when in the delivery configuration.

36. The system of claim 35, wherein proximal withdrawal of the slideable containment sleeve removes the circumferential, inward force on the plurality of arms.

37. The system of claim 25, wherein the interior volume in the deployed configuration comprises a fusiform, tubular, oblong, or spheroid shape.

38. The system of claim 25, wherein the deployed configuration of the plurality of elongate arms comprises a whisk, coil, spring, chain-link, or woven basket shape.

39. The system of claim 25, wherein the interior volume is filled with one or more therapeutic materials.

40. The system of claim 39, wherein the therapeutic materials are selected from the group consisting of bone growth material, bone graft material, bone void filler, cancellous bone graft, cortical bone graft, cancellous bone fragment, cortical bone fragment, osteoconductive material, osteoproliferative material, osteoinductive material, a bone morphogenic cytokine, BMP-2, collagen sponge soaked in bone material, or BMP-2 soaked collagen sponge.

41. The system of claim 39, wherein the tensioning element seals the interior volume at the distal end portion and the proximal end portion.

42. The system of claim 39, wherein the tensioning element radially displaces and distributes the therapeutic material within the interior volume.

43. The system of claim 25, wherein the plurality of elongate arms is comprised of a material selected from the group consisting of nitinol, titanium/nickel alloy, and a polymeric material.

44. The system of claim 25, wherein the cannula assembly is configured to reversibly couple to the interbody device.

45. The system of claim 25, wherein the distal coupling element of the control sleeve reversibly couples to the proximal end portion of the interbody device.

46. A method of manufacturing a spinal stabilization device, comprising:

providing a tubular element having an inner passageway and an axial length, the tubular element being made of a shape memory material;

providing a laser system;

removing portions of the tubular element with the laser system using cut lines parallel to the axial length of the tubular element, wherein removing portions defines openings through the element and creates a plurality of elongate, axially-aligned flexible arms surrounding the inner passageway having a first thickness and a plurality of spaces between the arms;

removing a layer of material from the arms with the laser system using cut lines transverse to the axial length of the tubular element, wherein removing the layer of material creates regions of the arms having a second thickness that is thinner than the first thickness;

setting the shape memory of the tubular element in a radially expanded, axially foreshortened configuration;

coupling a flexible, limit band circumferentially to the plurality of arms to the regions of the arms having the second thickness; and

compressing the tubular element into a radially contracted, axially elongated configuration.

47. The method of claim 46, wherein compressing the tubular element comprises cooling the tubular element.

48. The method of claim 46, wherein setting the shape memory comprises heat-setting the shape memory of the tubular element.

49. The method of claim 46, wherein the shape memory material comprises nitinol, titanium/nickel alloy, or a polymeric material.

50. The method of claim 46, wherein the arms are self-expanding.