Method, composition and kit for treating degenerated disc disease and discogenic pain

• US 20070286881A1
• Filed: 05/24/2007
• Published: 12/13/2007
• Est. Priority Date: 07/14/2005
• Status: Abandoned Application

• Current Assignee: Spinal Restoration, Inc.
• Original Assignee: Spinal Restoration, Inc.
• Inventors: Burkinshsw, Brian
• Application Number:
  US11/802,642
• Publication Number:
  US 20070286881A1
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61K 31/5415 ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
• CPC Class Codes: A61K 38/363 Fibrinogen
• CPC Class Codes: A61K 38/4833 Thrombin (3.4.21.5)
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders

Abstract

A method, and a corresponding kit and a pharmaceutical composition, is effective for treating discogenic pain caused by a degenerated disc. The method includes injecting a neurotropic agent and polymeric carrier, such as a fibrin sealant, into the degenerated disc. The fibrin sealant injected into the disc includes fibrinogen and an activating compound. The neurotropic agent may be injected before, simultaneously with, or after the injection of the fibrin sealant.

Claims

1. A method of treating discogenic pain caused by a degenerated disc, comprising:

injecting an effective amount of a neurotropic agent into the degenerated disc; and

injecting an effective amount of a polymeric carrier into the degenerated disc.

2. The method of claim 1, wherein the polymeric carrier is fibrin sealant, and, wherein injecting an effective amount of the fibrin sealant comprises mixing fibrinogen and an activating agent, whereby the fibrin sealant is formed.

3. The method of claim 2, wherein the neurotropic agent is injected simultaneously with the fibrin sealant, and wherein the fibrinogen and the activating agent are mixed during injection.

4. The method of claim 2, wherein the neurotropic agent is injected simultaneously with the fibrin sealant, the method further comprising pre-mixing the neurotropic agent with one of the fibrinogen and the activating agent prior to the neurotropic agent injection.

5. The method of claim 4, wherein the activating agent is thrombin and the neurotropic agent is methylene blue.

6. The method of claim 2, wherein the neurotropic agent and the fibrin sealant are injected sequentially and wherein the neurotropic agent is injected first.

7. The method of claim 2, wherein the neurotropic agent destroys/disrupts rogue nerves and is the activating agent that activates the fibrinogen to form the fibrin sealant.

8. The method of claim 2, wherein the neurotropic agent and the fibrin sealant are injected sequentially and wherein the fibrin sealant is injected first.

9. The method of claim 2, further comprising injecting the disc with the neurotropic agent and the fibrin sealant at multiple sites.

10. The method of claim 2, wherein the activating agent is thrombin.

11. The method of claim 2, wherein the fibrinogen is autologous fibrinogen.

12. The method of claim 1, wherein the polymeric carrier is degradeable/biodegradeable.

13. The method of claim 1, wherein the polymeric carrier is non-degradeable/non-biodegradeable.

14. The method of claim 1, wherein the polymeric carrier, after injection, forms a matrix that provides for controlled release of the neurotropic agent.

15. The method of claim 1, wherein the neurotropic agent is selected from the group consisting of methylene blue, phenol, phenyl combined with glycerine, ethyl alcohol, hypertonic saline, ammonium salt solutions, chlorocresol, botox, batrxobin, various viper snake venoms, extracts or refinements thereof, Aloe Vera extracts, and mixtures thereof.

16. The method of claim 1, further comprising injecting an anesthetic with one of the neurotropic agent and the polymeric carrier.

17. The method of claim 16, wherein the anesthetic, polymeric carrier and the neurotropic agent are injected sequentially and wherein the anesthetic is injected first.

18. The method of claim 16, wherein the anesthetic is a local anesthetic.

19. The method of claim 18, wherein the local anesthetic is selected from the group consisting of lidocaine, saparin, and bupivacaine.

20. The method of claim 1, wherein the neurotropic agent or the fibrin sealant further comprises at least one additive.

21. The method of claim 20, wherein the additive is selected from the group consisting of 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;

analgesics;

oncology agents;

cardiovascular drugs;

vitamins and other nutritional supplements;

hormones;

glycoproteins;

fibronectin;

peptides including polypeptides and proteins;

interferons;

cartilage inducing factors;

protease inhibitors;

vasoconstrictors, vasodilators, demineralized bone or bone morphogenetic proteins;

hormones;

lipids;

carbohydrates;

proteoglycans;

antiangiogenins;

antigens;

DBM;

hyaluronic acid and salts and derivatives thereof;

polysaccharides;

cellulose compounds and derivatives thereof;

antibodies;

gene therapy reagents;

genetically altered cells, stem cells including mesenchymal stem cells with transforming growth factor, and/or other cells;

cell growth factors;

type II collagen;

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;

oxygen-containing components;

enzymes;

melatonin;

vitamins; and

nutrients.

22. The method of claim 1, further comprising forming the fibrin sealant in the presence of aprotinin and calcium ions.

23. The method of claim 1, wherein the injection is performed using a dual syringe injector.

24. The method of claim 1, wherein the injection is performed using a coaxial needle.

25. The method of claim 1, wherein the injection is performed using a multi-lumen needle.

26. The method of claim 1, wherein the injection is performed using a multi-lumen catheter.

27. The method of claim 1, further comprising injecting the neurotropic agent and the fibrin sealant in volumes sufficient to restore normal hydrostatic pressure in the disc or normal disc height, or both.

28. The method of claim 1, wherein the injecting steps comprise:

inserting an introducer needle having a tip into an intradiscal space of the degenerated disc to a position adjacent to a defect;

inserting a second needle or a polymeric catheter through the introducer needle up to but not beyond the tip of the introducer needle; and

injecting the neurotropic agent and the fibrin sealant through the needle or catheter assembly.

29. The method of claim 1, wherein the degenerated disc is a lumbar disc.

30. The method of claim 1, wherein the degenerated disc is a cervical disc.

31. The method of claim 1, wherein the degenerated disc is a thoracic disc.

32. The method of claim 1, further comprising injecting a contrast agent into the degenerated disc before the injection of the neurotropic agent, the fibrin sealant, or a mixture of the neurotropic agent and the fibrin sealant.

33. The method of claim 1, wherein a contrast agent is injected into the degenerated disc with the neurotropic agent, the fibrin sealant, or a mixture of the neurotropic agent and the fibrin sealant.

34. A kit for treating discogenic pain caused by a degenerated disc, comprising:

a neurotropic agent;

a fibrinogen; and

an activating agent, wherein the fibrinogen and the activating agent are kept in different containers.

35. The kit of claim 34, further comprising an anesthetic.

36. The kit of claim 35, wherein the anesthetic is a local anesthetic selected from the group consisting of lidocaine, sarapin or bupivicaine.

37. The kit of claim 34, wherein at least one of the neurotropic agent, the fibrinogen, and the activating agent is in a freeze-dried form, a liquid form, a frozen form or combinations thereof.

38. The kit of claim 37, further comprising at least one reconstituting solution.

39. The kit of claim 38, wherein the activating agent is thrombin and wherein the at least one reconstitution solution comprises aprotinin, or calcium ions, or both.

40. The kit of claim 39, wherein the neurotropic agent comprises methylene blue.

41. The kit of claim 34, further comprising one or more additives selected from the group consisting of 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;

analgesics;

oncology agents;

cardiovascular drugs;

vitamins and other nutritional supplements;

hormones;

glycoproteins;

fibronectin;

peptides including polypeptides and proteins;

interferons;

cartilage inducing factors;

protease inhibitors;

vasoconstrictors, vasodilators, demineralized bone or bone morphogenetic proteins;

hormones;

lipids;

carbohydrates;

proteoglycans;

antiangiogenins;

antigens;

DBM;

hyaluronic acid and salts and derivatives thereof;

polysaccharides;

cellulose compounds and derivatives thereof;

antibodies;

gene therapy reagents;

genetically altered cells, stem cells including mesenchymal stem cells with transforming growth factor, and/or other cells;

cell growth factors;

type II collagen;

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;

oxygen-containing components;

enzymes;

melatonin;

vitamins; and

nutrients.

42. The kit of claim 34, further comprising at least one of an introducer needle, a spinal needle, a polymeric catheter, a coaxial spinal needle, a multi-lumen spinal needle and a multi-lumen catheter.

43. The kit of claim 42, further comprising a dual syringe injector.

44. A pharmaceutical composition for treating degenerative disc diseases, comprising:

a neurotropic agent;

a fibrinogen;

an activating agent

45. The pharmaceutical composition of claim 44, further comprising an anesthetic.

46. The pharmaceutical composition of claim 44, further comprising one or more additives.

47. The pharmaceutical composition of claim 44, wherein the neurotropic agent is methylene blue, and the activating agent is thrombin.

48. The pharmaceutical composition of claim 47, further comprising aprotinin and calcium chloride.

49. A method of treating discogenic pain caused by a degenerated disc, comprising:

injecting an effective amount of a neurotropic agent into the degenerated disc; and

injecting an effective amount of a fibrin sealant into the degenerated disc, wherein injecting an effective amount of the fibrin sealant comprises mixing fibrinogen and an activating agent, whereby the fibrin sealant is formed, and wherein the neurotropic agent and the fibrin sealant are injected together in a single injection and the neurotropic agent also serves as the activating agent.

50. The method of claim 49, wherein the neurotropic agent is derived from snake venom.

51. The method of claim 50, wherein the neurotropic agent is batroxobin.

52. A method for treating degenerated disc disease and associated discogenic pain, comprising:

injecting an effective amount of a neurotropic agent into a degenerated disc;

injecting a resorbable, biologic carrier into the disc to form a matrix that seals fissures in the disc.