Collagen-based materials and methods for augmenting intervertebral discs

• US 20050197707A1
• Filed: 04/28/2005
• Published: 09/08/2005
• Est. Priority Date: 09/18/2002
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Sherman, Michael C., Trieu, Hai H.
• Granted Patent: US 7,713,303 B2
• Time in Patent Office: Days
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/562 Implants for placement in joint gaps without restricting joint motion, e.g. to reduce arthritic pain
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• 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 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30224 cylindrical
• 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 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/445 Intervertebral disc tissue harvest sites
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/24 for joint reconstruction
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/24 : Collagen
• CPC Class Codes: A61L 27/36 : containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/3856 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/18 : Materials at least partially X-ray or laser opaque

Abstract

A method of augmenting an intervertebral disc by injecting particles of collagen-based material into the disc. The particles may be dehydrated before implantation, and rehydrated after implantation, or they may be implanted in a “wet” state—such as a slurry or gel. Radiocontrast materials may be included to enhance imaging of the injected material. Other additives may include analgesics, antibiotics, proteoglycans, growth factors, and/or other cells effective to promote healing and/or proper disc function.

Claims

1. A method of augmenting an intervertebral disc, said method comprising surgically adding to the nucleus of an intervertebral disc small particles of natural, collagen-rich tissue.

2. The method of claim 1 wherein said surgically adding step comprises injecting small particles of natural, collagen-rich tissue into the nucleus of an intervertebral disc.

3. The method of claim 1 wherein said small particles of natural, collagen-rich tissue comprises particles ranging from 0.05 mm to 5 mm in size.

4. The method of claim 1 wherein said small particles of natural, collagen-rich tissue comprises particles ranging from 0.05 mm to 3 mm in size.

5. The method of claim 1 wherein said small particles of natural, collagen-rich tissue comprises particles ranging from 0.05 mm to 1 mm in size.

6. The method of claim 1 wherein said small particles of natural, collagen-rich tissue comprises particles ranging from 0.25 mm to 1 mm in size.

7. The method of claim 1 wherein said small particles of natural, collagen-rich tissue are injected in a dehydrated state.

8. The method of claim 1 wherein said small particles of natural, collagen-rich tissue are injected in a non-dehydrated state.

9. The method of claim 8 wherein said small particles of natural, collagen-rich tissue are injected as a gel.

10. The method of claim 8 wherein said small particles of natural, collagen-rich tissue are injected as a solution or suspension.

11. The method of claim 1 wherein said small particles of natural, collagen-rich tissue are provided as a formulation that additionally includes a cross-linking agent to promote crosslinking of collagen molecules contained in the small particles of natural, collagen-rich tissue.

12. The method of claim 1 wherein said small particles of natural, collagen-rich tissue are provided as a formulation that additionally includes a radiocontrast media.

13. The method of claim 1 wherein said small particles of natural, collagen-rich tissue are provided as a formulation that additionally includes an analgesic.

14. The method of claim 1 wherein said small particles of natural, collagen-rich tissue are provided as a formulation that additionally includes an antibiotic.

15. The method of claim 1 wherein said small particles of natural, collagen-rich tissue are provided as a formulation that additionally includes proteoglycans.

16. The method of claim 1 wherein said small particles of natural, collagen-rich tissue are provided as a formulation that additionally includes growth factors.

17. The method of claim 1 wherein said small particles of natural, collagen-rich tissue are provided as a formulation that additionally includes one or more other types of cells effective to promote healing, repair, regeneration and/or restoration of the disc, and/or to facilitate proper disc function.

18. An intervertebral disc nucleus augmented with small particles of natural, collagen-rich tissue.

19. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue comprise small particles of natural, collagen-rich tissue that have been injected into the disc nucleus.

20. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue comprise particles ranging from 0.05 mm to 5 mm in size.

21. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue comprise particles ranging from 0.05 mm to 3 mm in size.

22. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue comprise particles ranging from 0.05 mm to 1 mm in size.

23. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue comprise particles ranging from 0.25 mm to 1 mm in size.

24. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue comprise collagen-based materials that have been reconstituted in the disc from dehydrated collagen-based materials.

25. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue comprises collagen-based materials that were injected into the disc in a non-dehydrated state.

26. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue comprise collagen-based materials that were injected into the disc as a gel.

27. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue comprise small particles of natural, collagen-rich tissue that were injected into the disc as a solution or suspension.

28. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue additionally include a cross-linking agent to promote crosslinking of collagen molecules.

29. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue additionally include a radiocontrast media.

30. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue additionally include an analgesic.

31. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue additionally include an antibiotic.

32. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue additionally include proteoglycans.

33. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue additionally include growth factors.

34. The augmented disc of claim 18 wherein said small particles of natural, collagen-rich tissue additionally include one or more other types of cells effective to promote healing, repair, regeneration and/or restoration of the disc, and/or to facilitate proper disc function.