Methods and devices for intervertebral augmentation using injectable formulations and enclosures

• US 20070150059A1
• Filed: 12/22/2005
• Published: 06/28/2007
• Est. Priority Date: 12/22/2005
• Status: Abandoned Application

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Spine Incorporated (Johnson & Johnson)
• Inventors: Ruberte, Ramon, O'Neil, Michael
• Application Number:
  US11/316,604
• Publication Number:
  US 20070150059A1
• Time in Patent Office: Days
• US Class Current: 623/17.120
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30136 undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
• CPC Class Codes: A61F 2002/30293 Cylindrical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/30565 having spring elements
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30588 filled with solid particles
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30932 for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• 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 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61L 24/0005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 24/0042 : Materials resorbable by the body

Abstract

Devices and methods for treating diseased or damaged portions of an intervertebral region are provided. In particular, intervertebral implants that can include use of a tissue regeneration structure having small intestine submucosa are described. The intervertebral implants can be utilized with any combination of load bearing structures for supporting loading on the implant, shaping structures for biasing the configuration of the implant, collapsible support structures for shaping the implant, and other features. Implants can also be formed with an enclosure to contain a filling material, such as an injectable small intestine submucosa formulation. Methods of delivering and utilizing the various implants are also discussed.

Claims

1. A method of repairing a diseased or damaged portion of an intervertebral disc, comprising:

creating a void space in a diseased or damaged portion of a spinal column, the void space accessible through at least one opening in the intervertebral disc;

delivering an injectable implant material comprising small intestine submucosa particulates into at least a portion of the void space, the injectable implant material adapted to be effective to support intervertebral loading; and

closing the at least one opening to encapsulate the injectable implant material within the void space.

2. The method of claim 1, wherein the injectable implant material includes growth factors.

3. The method of claim 1, wherein the injectable implant material includes at least one of annular fibrosis cells, nuclear pulposus cells, and chondrocytes.

4. The method of claim 1, wherein the injectable implant material includes an osteoconductive carrier.

5. The method of claim 1, further comprising:

transforming the injectable implant material into a gelled material after injection into the void space.

6. The method of claim 5, further comprising, wherein the step of transforming includes crosslinking a polymer with an agent in the injectable implant material after delivering the injectable implant material.

7. The method of claim 1, wherein the void space is created in a location formerly having at least a portion of a nuclear pulposus.

8. The method of claim 1, wherein the step of closing the at least one opening includes adding a gel comprising a resorbable material to the at least one opening.

9. The method of claim 1, wherein the step of closing the at least one opening includes blocking at least a portion of the at least one opening with a plug structure comprising a resorbable material.

10. The method of claim 9, wherein the plug structure is coupled to a securing device comprising a resorbable material effective to attach the plug structure to tissue.

11. The method of claim 1, further comprising:

delivering an enclosure having at least one port to the void space before delivering the injectable implant material, the at least one port being aligned with the at least one opening, wherein delivering the injectable implant material includes delivering the injectable implant material into the enclosure.

12. The method of claim 11, wherein delivering the enclosure includes delivering an a collapsible support structure contacting a peripheral portion of the enclosure effective to constrain expansion of the enclosure.

13. The method of claim 12, further comprising:

removing the collapsible support structure after delivering the injectable implant material into the enclosure.

14. The method of claim 11, wherein closing the at least one opening includes closing the at least one port of the enclosure.

15. An intervertebral implant comprising:

a collapsible enclosure having at least one port, the collapsible enclosure comprising at least one small intestine submucosa layer; and

a volume filling material comprising fluid located within the collapsible enclosure effective to support intervertebral loading on the implant.

16. The intervertebral implant of claim 15, wherein the collapsible enclosure further comprises a load bearing material having a higher compressive modulus than small intestine submucosa.

17. The intervertebral implant of claim 15, wherein the collapsible enclosure includes a tab structure for securing the collapsible enclosure to tissue.

18. The intervertebral implant of claim 15, wherein the collapsible enclosure includes a drawstring for closing the at least one port.

19. The intervertebral implant of claim 15, further comprising:

a plug structure for blocking the at least one port of the collapsible enclosure.

20. The intervertebral implant of claim 15, further comprising:

a resorbable, expansion structure disposed within the enclosure, the expansion structure effective to expand the enclosure upon rotation of the expansion structure.

21. An intervertebral implant comprising:

a collapsible enclosure having at least one port, the collapsible enclosure comprising at least one small intestine submucosa layer;

a collapsible support structure disposed around a peripheral portion of the collapsible enclosure effective to constrain an expanded shape of the collapsible enclosure; and

a filling material located within the collapsible enclosure is effective to support loading on the implant.

22. The intervertebral implant of claim 21, wherein the collapsible support structure is a closed ring structure.

23. The intervertebral implant of claim 21, wherein the collapsible support structure comprises an elastic material.

24. The intervertebral implant of claim 21, wherein the at least one port of the collapsible enclosure is aligned with an opening in the collapsible support structure.

25. The intervertebral implant of claim 21, further comprising:

a plug structure for blocking the at least one port of the collapsible enclosure.