MULTI-COMPARTMENT EXPANDABLE DEVICES AND METHODS FOR INTERVERTEBRAL DISC EXPANSION AND AUGMENTATION

• US 20090222096A1
• Filed: 02/28/2008
• Published: 09/03/2009
• Est. Priority Date: 02/28/2008
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: TRIEU, Hai H.
• Application Number:
  US12/038,953
• Publication Number:
  US 20090222096A1
• Time in Patent Office: Days
• US Class Current: 623/17.160
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30016 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• 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 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell

Abstract

A method of augmenting the nucleus pulposus of an intervertebral disc comprises forming a passage through an annulus fibrosus surrounding the nucleus pulposus and inserting a space creating device comprising a plurality of chambers. Without removing a portion of the nucleus pulposus, plurality of chambers are filled to expand the space creating device to create a space within the nucleus pulposus. The method further comprises injecting at least one biocompatible material into the space within the nucleus pulposus.

Claims

1. A method of augmenting the nucleus pulposus of an intervertebral disc, the method comprising:

forming a passage through an annulus fibrosus surrounding the nucleus pulposus;

inserting a space creating device comprising a plurality of chambers;

without removing a portion of the nucleus pulposus, filling the plurality of chambers to expand the space creating device to create a space within the nucleus pulposus; and

injecting at least one biocompatible material into the space within the nucleus pulposus.

2. The method of claim 1 further comprising:

removing the space creating device from the nucleus pulposus.

3. The method of claim 1 wherein the plurality of chambers are a plurality of clustered lobes.

4. The method of claim 3 wherein the step of injecting further comprises filling one of the plurality of clustered lobes less than another of the plurality of clustered lobes.

5. The method of claim 1 wherein the step of injecting comprises filling an outer ring chamber and a central chamber of the space creating device with the at least one biocompatible material, wherein the central chamber comprises a cylindrical body bounded by a pair of curved surfaces.

6. The method of claim 5 wherein the at least one biocompatible material comprises first and second biocompatible materials and the step of filling comprising filling the central chamber with the first biocompatible material and filling the outer ring chamber with the second biocompatible material, wherein the first biocompatible material is harder than the second biocompatible material.

7. The method of claim 5 further comprising anchoring at least one of the curved surfaces into a vertebral endplate adjacent the intervertebral disc.

8. The method of claim 1 wherein the step of injecting comprises filling an outer ring chamber and a central chamber of the space creating device with the at least one biocompatible material, wherein the central chamber is spherical and includes a curved surface adapted to extend beyond the outer ring chamber to penetrate a vertebral endplate adjacent to the intervertebral disc.

9. The method of claim 1 wherein the space creating device is fusiform shaped.

10. The method of claim 1 wherein the space creating device is ellipsoid.

11. The method of claim 1 wherein the space creating device comprises an annular occlusion chamber.

12. The method of claim 1 wherein the space creating device comprises at least three serially connected chambers.

13. The method of claim 1 wherein the step of expanding the space creating device further comprises unrolling the space creating device within the nucleus pulposus.

14. The method of claim 1 wherein the at least one biocompatible material is curable in-situ.

15. The method of claim 1 wherein the at least one biocompatible material is polymerizable in-situ.

16. A device for supplementing a nucleus pulposus comprising:

an expandable central body comprising a cylindrical portion bounded by a pair of curved surfaces and adapted to receive a first biocompatible material, wherein at least one of the pair of curved surfaces is adapted to penetrate a vertebral endplate adjacent the nucleus pulposus and

an expandable ring member surrounding the cylindrical portion and adapted to receive a second biocompatible material.

17. The device of claim 16 wherein the first biocompatible material has a hardness measurement greater than the second biocompatible material.

18. The device of claim 16 wherein the second biocompatible material has a hardness measurement greater than the first biocompatible material.

19. The device of claim 16 wherein the expandable ring member is attached to the expandable central body.

20. The device of claim 16 wherein the first biocompatible material is polymethylmethacrylate.

21. The device of claim 16 wherein the second biocompatible material is silicone.

22. The device of claim 16 wherein the expandable central body and ring member are adapted to pass through an opening in an annulus fibrosus to supplement the nucleus pulposus, wherein the nucleus pulposus is unresected.

23. The device of claim 16 wherein the first biocompatible material is curable in-situ.

24. The device of claim 16 wherein the central body is affixed to the ring member.

25. A device for supplementing a nucleus pulposus comprising:

an expandable central body comprising a spherical portion, including a pair of curved surfaces, and adapted to receive a first biocompatible material, wherein at least one of the pair of curved surfaces is adapted to penetrate a vertebral endplate adjacent the nucleus pulposus and

an expandable ring member encircling the central body and adapted to receive a second biocompatible material.

26. The device of claim 25 wherein the first biocompatible material is curable in-situ.

27. The device of claim 25 wherein the second biocompatible material is curable in-situ.

28. The device of claim 25 wherein the first biocompatible material is harder than the second biocompatible material.

29. The device of claim 25 wherein the central body is affixed to the ring member.

30. A system for treating a nucleus pulposus of an intervertebral disc, the system comprising:

a cannula adapted to access an annulus fibrosus of the intervertebral disc;

a multi-chamber spacing device comprising at least three inflatable chambers, wherein each of the inflatable chambers is connected to at least one other of the inflatable chambers and the spacing device is collapsible for passage through the cannula; and

a catheter connected to the spacing device and extendable through the cannula.

31. The system of claim 30 wherein each of the at least three inflatable chambers is adapted to receive a different flowable material.

32. The system of claim 30 wherein each of the at least three inflatable chambers is independently inflatable.

33. The system of claim 30 further comprising a pressure gauge for measuring the pressure in one of the at least three inflatable chambers.

34. A system for treating a nucleus pulposus of an intervertebral disc, the system comprising:

a cannula adapted to access an annulus fibrosus of the intervertebral disc;

a multi-chamber spacing device comprising two connected and inflatable chambers, wherein one of the inflatable chambers is expandable along the annulus fibrosus; and

a catheter connected to the spacing device and extendable through the cannula.

35. The system of claim 34 wherein the nucleus pulposus is unresected.

36. The system of claim 34 wherein the inflatable chamber expandable along the annulus fibrosus is adapted to contain a more rigid material than the other of the inflatable chambers.

37. The system of claim 34 wherein the inflatable chamber expandable along the annulus fibrosus is adapted to receive a resorbable material.

38. The system of claim 34 wherein the inflatable chamber expandable along the annulus fibrosus is adapted to occlude a defect in the annulus fibrosus.