Injection of fibrin sealant including an anesthetic in spinal applications

• US 20060095016A1
• Filed: 08/17/2005
• Published: 05/04/2006
• Est. Priority Date: 10/29/2004
• Status: Active Grant

• Current Assignee: Kevin Pauza
• Original Assignee: Spinal Restoration, Inc.
• Inventors: Burkinshaw, Brian D., Whitlock, Steven I., Pauza, Kevin, Rogan, James B., Richards, Mark I.
• Granted Patent: US 7,597,687 B2
• Time in Patent Office: Days
• US Class Current: 604/512
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/363 Fibrinogen
• CPC Class Codes: A61K 38/4833 Thrombin (3.4.21.5)
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 24/043 Mixtures of macromolecular materials
• CPC Class Codes: A61L 24/106 Fibrin; Fibrinogen
• 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 27/225 Fibrin; Fibrinogen
• 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: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 23/00 Anaesthetics

Abstract

A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.

Claims

1. A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus, comprising:

injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.

2. The method of claim 1, with the proviso that neither the nucleus pulposus nor the annulus fibrosus has been heated.

3. The method of claim 1, wherein the fibrin sealant consists essentially of fibrinogen, the activating compound and the anesthetic, optionally at least one additive, and optionally calcium chloride.

4. The method of claim 1, wherein the fibrin sealant consists of fibrinogen, an activating compound and the anesthetic, optionally the at least one additive, and optionally containing calcium chloride.

5. The method of claim 1, wherein calcium chloride is injected with the fibrinogen and the activating compound.

6. The method of claim 1, wherein the activating compound is thrombin.

7. The method of claim 1, wherein the method consists of the injecting step.

8. The method of claim 1, the anesthetic is lidocaine, sarapin or bupivicaine.

9. The method of claim 1, wherein at least one additive is also injected.

10. The method of claim 1, wherein no portion of the nucleus pulposus has been removed by surgery.

11. The method of claim 1, wherein the at least one defect is a tear or fissure in the annulus fibrosus.

12. The method of claim 1, wherein normal hydrostatic pressure in the disc is restored.

13. The method of claim 1, wherein normal disc height is restored.

14. The method of claim 1, wherein the fibrinogen is autologous.

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

16. The method of claim 1, wherein the activating compound is thrombin, and wherein a mixture of anesthetic, fibrinogen and thrombin is injected.

17. The method of claim 1, wherein the activating compound is thrombin, and wherein the fibrinogen and thrombin are injected sequentially and at least partially mix in the disc.

18. The method of claim 1, wherein the anesthetic is injected sequentially either before, with or after the fibrinogen and thrombin and at least partially mix in the disc.

19. The method of claim 1, wherein the disc is injected with the fibrin sealant at multiple points.

20. The method of claim 1, wherein the injecting occurs by inserting an introducer needle having a tip into the intra-discal space to a position adjacent to the at least one 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 fibrin sealant through the second needle or polymeric catheter.

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

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

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

24. The method of claim 1, wherein a contrast agent is injected either before the fibrin sealant, with the fibrin sealant, or after the fibrin sealant has been injected.

25. A method of treating a human back, comprising injecting a fibrin sealant into a disc to seal at least one defect of an annulus fibrosus, wherein the fibrin sealant comprises an anesthetic, fibrinogen and thrombin, wherein the fibrinogen and thrombin forms at least a portion of the fibrin after injection, and wherein the fibrin sealant does not include a corticosteroid.

26-47. -47. (canceled)

48. A method of treating a human back, comprising providing a mixture of anesthetic, fibrinogen and thrombin within a human disc to treat at least one defect of an annulus fibrosus, and wherein a corticosteroid is absent from the mixture.

49-69. -69. (canceled)

70. A kit, comprising:

an anesthetic, fibrinogen, thrombin, optionally at least one additive, a spinal needle, wherein the kit excludes corticosteroid and wherein the kit excludes a device to provide thermal energy to a disc.

71-76. -76. (canceled)

77. A process for manufacturing a kit, comprising:

providing a fibrinogen component, a thrombin component, an anesthetic component, and a spinal needle or a polymeric catheter or both, wherein the kit excludes corticosteroid and wherein the kit excludes a device to provide thermal energy to a disc.

78-79. -79. (canceled)