Compositions and methods for treating intervertebral discs with collagen-based materials

• US 20050119754A1
• Filed: 01/06/2005
• Published: 06/02/2005
• 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 7,744,651 B2
• Time in Patent Office: Days
• US Class Current: 623/17.160
• 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 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• 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 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• 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 2002/4077 Distal or diaphyseal parts of shafts
• 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 2002/4635 using minimally invasive surgery
• 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 2300/402 : Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/406 : Antibiotics
• CPC Class Codes: A61L 2300/41 : Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 2300/44 : Radioisotopes, radionuclides
• CPC Class Codes: A61L 2300/64 : Animal cells
• 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 27/3604 : characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3658 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/3834 : Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• 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 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• 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 nucleus by injecting or otherwise adding to a disc nucleus a plurality of particles of natural, collagen-rich tissue. The mean particle size of the pieces of natural, collagen-rich tissue may be between 0.25 mm and 1.0 mm. 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, stem cells, and/or other cells effective to promote healing and/or proper disc function.

Claims

1. A method of augmenting intervertebral disc nucleus, said method comprising surgically adding to an intervertebral disc nucleus contained within a disc annulus:

a) a plurality of particles of natural, collagen-rich tissue, wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.05 mm and 5.0 mm; and

b) a biologically active substance effective to promote healing, repair, regeneration and/or restoration of the disc, and/or to facilitate proper disc function.

2. The method of claim 1 wherein said biologically active substance is a growth factor.

3. The method of claim 2 wherein said growth factor comprises one or more members selected from the group consisting of bone morphogenetic protein, transforming growth factor-β

(TGF-β

), insulin-like growth factor, platelet-derived growth factor, fibroblast growth factor, or other growth factors having the ability to repair the endplates and/or the annulus fibrosis of an intervertebral disc.

4. The method of claim 1 wherein said biologically active substance comprises one or more members selected from the group consisting of antibiotics, analgesics, anti-inflammatories, and steroids.

5. The method of claim 1 wherein said biologically active substance comprises stem cells.

6. The method of claim 1 wherein said method further includes adding a radiographic contrast media to the intervertebral disc nucleus.

7. The method of claim 1 wherein said method further includes adding a polysaccharide to the intervertebral disc nucleus.

8. The method of claim 7 wherein said polysaccharide is a proteoglycan and/or a hyaluronic acid.

9. The method of claim 1 wherein said method further includes adding a cross-linking agent to the intervertebral disc nucleus, to promote crosslinking of collagen molecules.

10. The method of claim 1 wherein said biologically active substance is effective for treating one or more medical conditions selected from the group consisting of degenerative disc disease, spinal arthritis, spinal infection, spinal tumor, and osteoporosis.

11. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.25 mm and 1.0 mm.

12. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.25 mm and 0.5 mm.

13. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.5 mm and 1.0 mm.

14. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue are added to the disc nucleus in a dehydrated state.

15. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue are added to the disc nucleus in a non-dehydrated state.

16. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue are added to the disc nucleus as a gel.

17. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue are added to the disc nucleus as a suspension.

18. The method of claim 1 wherein said natural, collagen-rich tissue is an allograft tissue.

19. The method of claim 1 wherein said natural, collagen-rich tissue is an autograft tissue.

20. The method of claim 1 wherein said natural, collagen-rich tissue is a xenograft tissue.

21. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue, and said biologically active substance are surgically added simultaneously.

22. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue, and said biologically active substance are surgically added sequentially.

23. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue, and said biologically active substance are surgically added by needle injection.

24. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue, and said biologically active substance are surgically added by catheter infusion.

25. The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue, and said biologically active substance are surgically added by extrusion.

26. A kit for augmenting an intervertebral disc nucleus, said kit comprising:

a) a plurality of particles of natural, collagen-rich tissue, wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.05 mm and 5.0 mm; and

b) a biologically active substance effective to promote healing, repair, regeneration and/or restoration of the disc, and/or to facilitate proper disc function.

27. An augmented intervertebral disc, comprising:

a) a disc annulus fibrosis;

b) a surgically-added plurality of particles of natural, collagen-rich tissue, wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.05 mm and 5.0 mm; and

c) a surgically-added biologically active substance effective to promote healing, repair, regeneration and/or restoration of the disc, and/or to facilitate proper disc function.

28. A composition effective for augmenting intervertebral disc nucleus, said composition comprising:

a) a plurality of particles of natural, collagen-rich tissue, wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.05 mm and 5.0 mm; and

b) a biologically active substance effective to promote healing, repair, regeneration and/or restoration of the disc, and/or to facilitate proper disc function.