Method for repairing intervertebral discs

• US 20080103564A1
• Filed: 02/16/2007
• Published: 05/01/2008
• Est. Priority Date: 08/17/2005
• Status: Active Grant

• Current Assignee: Kevin Pauza
• Original Assignee: Spinal Restoration, Inc.
• Inventors: Burkinshaw, Brian D., Whitlock, Steven I., Wheeler, John L., Rogan, James B.
• Granted Patent: US 8,357,147 B2
• Time in Patent Office: Days
• US Class Current: 607/96
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/222 Gelatin
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61M 2005/3114 Filling or refilling
• CPC Class Codes: A61M 2005/3152 including gearings to multiply or attenuate the piston displacing force
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/486 Indicating injection pressure
• CPC Class Codes: C08L 71/02 Polyalkylene oxides
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

A method of repairing a defect in an annulus fibrosus of an intervertebral disc, without excising the entire nucleus pulposus of the disc. The method includes inserting an introducer needle through the annulus fibrosus by puncturing the annulus fibrosus with the introducer needle, injecting an in situ curable, bio-compatible polymerizable or polymeric material composition into the disc through the introducer needle directly or indirectly so that the in situ curable composition contacts a defect in the annulus fibrosus; and curing said material in situ.

Claims

1. A method of repairing a defect in an annulus fibrosus of an intervertebral disc, without excising the entire nucleus pulposus of the disc, comprising:

inserting an introducer needle through the annulus fibrosus by puncturing the annulus fibrosus with the introducer needle, injecting an in situ curable, bio-compatible polymerizable or polymeric material composition into the disc through the introducer needle directly or indirectly so that the in situ curable composition contacts a defect in the annulus fibrosus; and

curing said material in situ.

2. A method as claimed in claim 1 wherein said curable material is in flowable liquid form.

3. A method as claimed in claim 1 wherein said curable material comprises a combination of at least two components, and wherein at least one of said components is a cross linkable material and at least one other of said components is a cross linking agent for said cross linkable material.

4. A method as claimed in claim 3 wherein said cross linking agent is a polymeric compound having at least two epoxy groups therein.

5. A method as claimed in claim 3 wherein said cross linking agent is a chemical cross linking agent that is reactive with said cross linkable material.

6. A method as claimed in claim 1 wherein said defect is an opening in said annulus fibrosus that has been caused surgically.

7. A method as claimed in claim 1 wherein said defect is an opening in said annulus fibrosus that has been caused by herniation.

8. A method as claimed in claim 1 wherein said defect is an opening in said annulus fibrosus that has been caused by trauma.

9. A method as claimed in claim 1 wherein said defect is an opening in said annulus fibrosus that has been caused by natural degeneration.

10. A method as claimed in claim 1 wherein said defect is an opening in said annulus fibrosus that has been caused by dehydration or loss of disc height due to dehydration.

11. A method as claimed in claim 1 wherein said curable material comprises at least one polymeric component.

12. A method as claimed in claim 1 wherein said curable material is cured in situ by the action of heat thereon.

13. A method as claimed in claim 1 wherein said curable material is cured in situ by the action of electromagnetic radiation thereon.

14. A method as claimed in claim 1 wherein said curable material is cured in situ by the action of UV light.

15. A method as claimed in claim 1 wherein said cross linkable material comprises a flowable, semi-solid material.

16. A method as claimed in claim 1 wherein said in situ cured material comprises a visco-elastic bio-compatible material that has physical properties that are at least substantially similar to the physical properties of said annulus fibrosus.

17. A method as claimed in claim 1 wherein said in situ curable material comprises a biological material.

18. A method as claimed in claim 1 wherein said in situ cured material is biodegradable over a period of time that is substantially equal to the period of time during which additional annulus fibrosus material grows to an extent sufficient to fill said defect.

19. A method as claimed in claim 1 wherein said in situ curing is accomplished in less than 2 hours.

20. A method as claimed in claim 1 wherein said in situ curing is accomplished in up to about 40 minutes.

21. A method as claimed in claim 1 wherein said in situ curing is accomplished after at least about 2 minutes.

22. A method as claimed in claim 1 wherein said in situ curing is accomplished after at least about 30 seconds.

23. A method as claimed in claim 1 wherein said cured material comprises a hydrogel.

24. A method as claimed in claim 1 wherein said defect in said annulus fibrosus comprises at least one fissure in the annulus fibrosus.

25. A method as claimed in claim 24 wherein said at least one fissure has been caused by disc degeneration.

26. A method as claimed in claim 1, wherein the injection of the situ curable, bio-compatible polymerizable or polymeric material composition is performed using an apparatus for percutaneous delivery of a sealant comprising:

at least two fluid reservoirs, the introducer needle having a distal tip that is in fluid communication with at least one reservoir, a fluid delivery tube that is in fluid communication with a second reservoir, wherein the fluid delivery tube has a tip.

27. A method as claimed in claim 26, wherein the fluid delivery tube is configured so that the tip of the fluid delivery tube does not extend past the distal tip of the introducer needle during use.

28. A method according to claim 26, further comprising a pharmaceutically active agents selected from the group consisting of growth factors, differentiation factors, enzymes, receptor agonists or antagonists, antibodies, hormones, analgesics, local anesthetics, anti-inflammatory drugs, such as Indomethacin and tiaprofenic acid, TNF-α

inhibitors, antibiotics, anti-microbial agents;

antibiotics;

antiproliferative, cytotoxic, and antitumor drugs including chemotherapeutic drugs;

analgesic;

antiangiogen;

antibody;

antivirals;

cytokines;

colony stimulating factors;

proteins;

chemoattractants;

EDTA;

histamine;

antihistamine;

erythropoietin;

antifungals;

antiparasitic agents;

non-corticosteroid anti-inflammatory agents;

anticoagulants;

anesthetics including local anesthetics such as lidocaine and bupivicaine;

analgesics;

oncology agents;

cardiovascular drugs;

nutritional supplements;

hormones;

glycoproteins;

fibronectin;

peptides;

interferons;

cartilage inducing factors;

protease inhibitors;

vasoconstrictors, vasodilators, demineralized bone or bone morphogenetic proteins;

hormones;

lipids;

carbohydrates;

proteoglycans, versican, decorin, and biglycan;

antiangiogenins;

antigens;

DBM;

hyaluronic acid and salts and derivatives thereof;

polysaccharides;

cellulose compounds;

antibodies;

gene therapy reagents;

genetically altered cells, stem cells;

cell growth factors;

type I and II collagen;

collagen hydrolysate;

elastin;

sulfated glycosaminoglycan (sGAG), glucosamine sulfate;

pH modifiers;

methylsulfonylmethane (MSM);

osteogenic compounds;

osteoconductive compounds;

plasminogen;

nucleotides;

oligonucleotides;

polynucleotides;

polymers;

osteogenic protein 1 (OP-1 including recombinant OP-1);

LMP-1 (Lim Mineralization Protein-1);

cartilage including autologous cartilage;

oxygen-containing components;

enzymes such as, for example, peroxidase, which mediate the release of oxygen from such components;

melatonin;

vitamins;

nutrients, and combinations thereof.

29. A method as claimed in claim 1, wherein the injection of the situ curable, bio-compatible polymerizable or polymeric material composition is performed using an apparatus for delivering a biocompatible sealant, comprising:

at least two reservoirs for fluids to be delivered, an actuation assembly that causes the fluids to flow out of the reservoir through an exit port in the reservoir, and a pressure monitor coupled to the delivery device to measure pressure within the device.

30. The method of claim 1, wherein the injection of the situ curable, bio-compatible polymerizable or polymeric material composition is performed using an apparatus comprises:

a multi-barrel syringe,

an introducer needle,

a fluid delivery tube adapted to receive fluid from a first barrel of the multi-barrel syringe and adapted to extend into the introducer needle, and

a connector coupled to a barrel of the multi-barrel syringe, wherein the connector is coupled to the introducer needle and adapted to receive the fluid delivery tube so that the fluid delivery tube extends into the introducer needle.

31. A kit comprising an in situ curable composition, an introducer needle, and a delivery device for injecting the composition.

32. A kit according to claim 31, wherein the kit further an apparatus for percutaneous delivery of a sealant comprising:

at least two fluid reservoirs, the introducer needle having a distal tip that is in fluid communication with at least one reservoir, a fluid delivery tube that is in fluid communication with a second reservoir, wherein the fluid delivery tube has a tip.

33. A kit according to claim 32, wherein the fluid delivery tube is configured so that the tip of the fluid delivery tube does not extend past the distal tip of the introducer needle during use.

34. A kit according to claim 31, further comprising a pharmaceutically active agents selected from the group consisting of growth factors, differentiation factors, enzymes, receptor agonists or antagonists, antibodies, hormones, analgesics, local anesthetics, anti-inflammatory drugs, such as Indomethacin and tiaprofenic acid, TNF-A inhibitors, antibiotics, anti-microbial agents;

antibiotics;

antiproliferative, cytotoxic, and antitumor drugs including chemotherapeutic drugs;

analgesic;

antiangiogen;

antibody;

antivirals;

cytokines;

colony stimulating factors;

proteins;

chemoattractants;

EDTA;

histamine;

antihistamine;

erythropoietin;

antifungals;

antiparasitic agents;

non-corticosteroid anti-inflammatory agents;

anticoagulants;

anesthetics including local anesthetics such as lidocaine and bupivicaine;

analgesics;

oncology agents;

cardiovascular drugs;

nutritional supplements;

hormones;

glycoproteins;

fibronectin;

peptides;

interferons;

cartilage inducing factors;

protease inhibitors;

vasoconstrictors, vasodilators, demineralized bone or bone morphogenetic proteins;

hormones;

lipids;

carbohydrates;

proteoglycans, versican, decorin, and biglycan;

antiangiogenins;

antigens;

DBM;

hyaluronic acid and salts and derivatives thereof;

polysaccharides;

cellulose compounds;

antibodies;

gene therapy reagents;

genetically altered cells, stem cells;

cell growth factors;

type I and II collagen;

collagen hydrolysate;

elastin;

sulfated glycosaminoglycan (sGAG), glucosamine sulfate;

pH modifiers;

methylsulfonylmethane (MSM);

osteogenic compounds;

osteoconductive compounds;

plasminogen;

nucleotides;

oligonucleotides;

polynucleotides;

polymers;

osteogenic protein 1 (OP-1 including recombinant OP-1);

LMP-1 (Lim Mineralization Protein-1);

cartilage including autologous cartilage;

oxygen-containing components;

enzymes such as, for example, peroxidase, which mediate the release of oxygen from such components;

melatonin;

vitamins;

nutrients, and combinations thereof.

35. A kit according to claim 31, further comprising an apparatus for delivering a biocompatible sealant, comprising:

at least two reservoirs for fluids to be delivered, an actuation assembly that causes the fluids to flow out of the reservoir through an exit port in the reservoir, and a pressure monitor coupled to the delivery device to measure pressure within the device.

36. The kit of claim 31, wherein the apparatus comprises:

a multi-barrel syringe,

an introducer needle,

a fluid delivery tube adapted to receive fluid from a first barrel of the multi-barrel syringe and adapted to extend into the introducer needle, and

a connector coupled to a barrel of the multi-barrel syringe, wherein the connector is coupled to the introducer needle and adapted to receive the fluid delivery tube so that the fluid delivery tube extends into the introducer needle.

37. The kit of claim 31, wherein the pressure monitor is contained within the housing.

38. The kit of claim 31, wherein the pressure monitor includes a display that is positioned toward the rear of the device above the handle.

39. The kit of claim 31, wherein the pressure monitor includes a display that is flush with the housing.

40. The kit of claim 31, wherein the pressure monitor is an electronic pressure monitor.

41. The kit of claim 31, wherein the pressure monitor includes a pressure transducer that is operably attached to at least one reservoir.

42. The kit of claim 31, wherein the fluid delivery tube is a needle.

43. The kit of claim 31, wherein the fluid delivery tube is a catheter.

44. The kit of claim 31, wherein the fluid delivery tube is integral with connector.

45. The kit of claim 31, wherein the fluid delivery tube couples to a first reservoir of the at least two reservoirs.

46. The kit of claim 31, wherein a connector provides a passage for fluid communication.

47. The kit of claim 31, wherein the passage between the fluid delivery tube and the introducer needle is of a diameter is of a volume approximately equal to the volume of fluid delivered through the fluid delivery tube.

48. The kit of claim 31, wherein the introducer needle couples to the at least one fluid reservoir by a luer fitting.

49. The kit of claim 31, wherein the introducer needle has a distal tip and wherein the fluid delivery tube has a tip that does not extend past the distal tip of the introducer needle during use such and which tip of the fluid delivery tube extends no more than 1 mm from the distal tip of the introducer needle.

50. The kit of claim 31, wherein the introducer needle has a distal tip and wherein the fluid delivery tube has a tip that does not extend past the distal tip of the introducer needle during use such and wherein the fluid delivery tube has a tip that extends no more than 1 mm from the tip of the introducer needle so that mixing of fibrin sealant injected through the fluid delivery tub and the introducer needle at least partially occurs in the introducer needle.

51. The kit of claim 31, wherein the fluid delivery tube directly couples to one of the at least two reservoirs, and wherein the fluid delivery tube is affixed to a connector so that the fluid delivery tube cannot move within the introducer needle.

52. The kit of claim 31, wherein introducer needle has a gauge in the range of 18 to 22.

53. The kit of claim 31, wherein apparatus is handheld.

54. The kit of claim 31, wherein the fluid delivery tube includes a plurality of holes toward the distal tip that permit fluid to exit the fluid delivery tube prior to the distal tip of the introducer needle.

55. The kit of claim 31, wherein the distal end of the fluid delivery tube is sealed and includes at least one hole in the side wall toward the distal tip that permits fluid to exit the fluid delivery tube prior to the distal tip.

56. The kit of claim 31, wherein the fluid delivery tube is of a length such that during use the fluid delivery tube extends within the introducer needle into the intra-discal space of a human disc, and wherein the fluid delivery tube is of a length such that fluid injected through the fluid delivery tube first contacts fluid injected through the introducer needle within the bore of the introducer needle.

57. The kit of claim 31, wherein the apparatus comprises:

a cartridge having at least two cylinder bores for fluids to be delivered, wherein each cylinder includes an exit port for a fluid,

a plunger within each cylinder for pushing the fluids out of the cylinder,

a housing adapted to receive the cartridge, wherein the housing includes an adaptor to receive and lock a manifold that operably connects to the exit ports of the cartridge,

at least two toothed rams, wherein each toothed ram is at least partially within a cylinder bore, and,

a pressure monitor.

58. A method of preparing a kit, comprising providing an in situ curable composition, an introducer needle, and a delivery device for injecting the composition.