Apparatus and method for injection of fibrin sealant in spinal applications

• US 20070191781A1
• Filed: 01/05/2007
• Published: 08/16/2007
• Est. Priority Date: 10/29/2004
• Status: Active Grant

• Current Assignee: Kevin Pauza
• Original Assignee: Spinal Restoration, Inc.
• Inventors: Richards, Mark, Pauza, Kevin, Wheeler, John, Burkinshaw, Brian, Rogan, James
• Granted Patent: US 8,419,722 B2
• Time in Patent Office: Days
• US Class Current: 604/191
• 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: A61M 2005/3152 including gearings to multiply or attenuate the piston displacing force
• CPC Class Codes: A61M 2005/3201 Coaxially assembled needle cannulas placed on top of another, e.g. needles having different diameters
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• 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 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button
• CPC Class Codes: A61M 5/31581 performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: A61M 5/31593 Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: A61M 5/486 Indicating injection pressure

Abstract

An apparatus for percutaneous delivery of a sealant comprising: at least two fluid reservoirs, an 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 and 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.

Claims

1. An apparatus for percutaneous delivery of a sealant comprising:

at least two fluid reservoirs, an 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 and 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.

2. The apparatus of claim 1, wherein the fluid delivery tube is a needle.

3. The apparatus of claim 1, wherein the fluid delivery tube is a catheter.

4. The apparatus of claim 1, wherein the fluid delivery tube is integral with connector.

5. The apparatus of claim 1, wherein the fluid delivery tube couples to a first reservoir of the at least two reservoirs.

6. The apparatus of claim 1, wherein a connector provides a passage for fluid communication.

7. The apparatus of claim 1, 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.

8. The apparatus of claim 1, wherein the introducer needle couples to the at least one fluid reservoir by a luer fitting.

9. The apparatus of claim 1, wherein at least two reservoirs constitute a multi-barrel syringe.

10. The apparatus of claim 1, wherein the fluid delivery tube does not protrude out the end of the introducer needle.

11. The apparatus of claim 1, 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.

12. The apparatus of claim 1, 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.

13. The apparatus of claim 1, 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.

14. The apparatus of claim 1, wherein introducer needle has a gauge in the range of 18 to 22.

15. The apparatus of claim 1, wherein apparatus is handheld.

16. The apparatus of claim 1, 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.

17. The apparatus of claim 1, 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.

18. The apparatus of claim 1, 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.

19. The apparatus of claim 1, 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.

20. The apparatus of claim 19, further comprising

a trigger connected to the housing, wherein the trigger includes a toothed drive rack,

a toothed wheel assembly that cooperates with the toothed drive rack and with the toothed rams.

21. The apparatus of claim 19, wherein the housing and the cartridge are together monolithic.

22. The apparatus of claim 19, wherein the cartridge is a separate component from the housing that is inserted into the housing.

23. The apparatus of claim 19, wherein the plungers are attached to the rams.

24. The apparatus of claim 1, wherein the sealant is fibrin sealant.

25. The apparatus of claim 1, wherein the sealant is a synthetic polymer.

26. The apparatus of claim 1, wherein the sealant is polyvinylpyrrolidone, polyvinyl alcohol, polyacrylic acid, polyethoxazoline, polyhydroxyethyl acrylate, polyhydroxyethyl methacrylate, polysaccharides, polypeptides, polymers made from polyethylene glycol, or mixtures thereof.

27. The device of claim 19, further comprising a delivery manifold for delivering the fluids, comprising a delivery adaptor that includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two conduits having two ends wherein a first end of each of the conduits connects to an exit port of the delivery manifold, and wherein a second end of each of the conduits connects to a duel port luer fittings, wherein the luer fitting is configured to delivery fluid from one conduit to an inner needle and wherein the luer fitting is configured to delivery fluid from the second conduit to a space defined by the exterior of the inner needle and by a second larger diameter needle that connects to the luer fitting with the inner needle being within the insider of the larger diameter needle.

28. The apparatus of claim 1, wherein the apparatus comprese:

a multi-barrel syringe,

an introducer needle having a distal tip,

a catheter that directly or indirectly couples to a first barrel of the multi-barrel syringe, wherein the catheter has a tip and wherein the catheter is configured so that the tip of the catheter does not extend past the distal tip of the introducer needle during use; and

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

29. The apparatus of claim 28, wherein the introducer needle couples to the connector by luer fitting at an end of the connector opposite to the end connected to the syringe.

30. The apparatus of claim 28, wherein the connector couples to the first barrel and the fluid delivery tube is integral with the connector.

31. The apparatus of claim 28, wherein the fluid delivery tube couples to the first syringe by a luer fitting, and wherein the fluid delivery tube inserts into a space in the connector through a plug and into the introducer needle, wherein the plug couples to the connector.

32. The apparatus of claim 28, wherein the at least two fluid reservoirs comprise a multi-barrel syringe having two barrels.

33. The apparatus of claim 28, wherein the fluid delivery tube couples to the connector by a luer fitting.

34. The apparatus of claim 28, wherein the connector is adapted for conveying fluid from the second syringe into the introducer needle.

35. The apparatus of claim 28, wherein the introducer needle has a distal tip and wherein the catheter has a tip that does not extend past the distal tip of the introducer needle during use such and which distal tip that extends no more than 1 mm from the distal tip of the introducer needle.

36. The apparatus of claim 28, wherein the introducer needle has a distal tip and wherein the catheter has a tip that does not extend past the distal tip of the introducer needle during use such and wherein the catheter has a tip that extends no more than 1 mm from the distal tip of the introducer needle so that mixing of fibrin sealant injected through the catheter and the introducer needle at least partially occurs in the introducer needle.

37. The apparatus of claim 28, wherein the catheter directly couples to the first barrel of the syringe, and wherein the catheter is affixed to the connector so that the catheter cannot move within the introducer needle.

38. The apparatus of claim 28, wherein introducer needle has a gauge in the range of 18 to 22.

39. The apparatus of claim 28, wherein the introducer needle has a distal tip and wherein the catheter has a tip that does not extend past the distal tip of the introducer needle during use such and wherein the catheter has a tip that extends no more than 1 mm from the distal tip of the introducer needle and no less than 5 mm from the tip of the introducer needle so that mixing of fibrin sealant injected through the spinal needle and the introducer needle at least partially occurs in the introducer needle.

40. The apparatus of claim 28, wherein the catheter includes a plurality of holes toward the tip that permits fluid to exit the catheter prior to the tip.

41. The apparatus of claim 28, 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.

42. The apparatus of claim 28, wherein the catheter is of a length such that during use the catheter extends within the introducer needle into the intra-discal space of a human disc, and wherein the catheter is of a length such that fluid injected through the catheter first contacts fluid injected through the introducer needle or a second lumen of the catheter within the bore of the introducer needle.

90. The kit of claim 61, wherein the apparatus is any of the apparatus of claims 1-42.

91. The method of claim 73, wherein the apparatus is any of the apparatus of claims 1-42.

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

inserting an introducer needle that can be attached to a connector into the disc, wherein the introducer needle has a distal tip;

inserting a fluid delivery tube that is attached to the connector into the introducer needle, wherein the fluid delivery tube has a tip and 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;

injecting a sealant begins mixing after the connector and within the space between the distal tip of the introducer needle and the tip of the fluid delivery tube.

44. The method of claim 43, wherein the fluid delivery tube is a multilumen catheter.

45. The method of claim 43, wherein the fluid delivery tube is a second needle, wherein a fibrinogen solution passes through the introducer needle and wherein an activating solution passes through the second needle.

46. The method of claim 43, wherein the fluid delivery tube is a second needle, wherein an activating solution passes through the introducer needle and wherein a fibrinogen solution passes through the second needle.

47. The method of claim 43, wherein the biologic sealant is fibrin sealant, and wherein calcium ions are injected with the fibrin sealant.

48. The method of claim 43, further comprising measuring the pressure of the fibrinogen solution and the activating solution while they are being injected.

49. The method of claim 43, wherein an additive is injected with the fibrinogen and the activating compound, 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 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;

oxygen-containing components;

enzymes;

melatonin;

vitamins;

nutrients; and

combinations thereof.

50. The method of claim 43, wherein the at least one defect is a tear or fissure in the annulus fibrosus.

51. The method of claim 43, wherein normal physiologic hydrostatic pressure in the disc is restored or normal disc height is restored or both.

52. The method of claim 43, wherein the biologic sealant is fibrin sealant and the fibrinogen of the fibrin sealant is autologous.

53. The method of claim 43, wherein the injection is performed using a dual barrel syringe.

54. The method of claim 43, wherein the disc is a lumbar disc.

55. The method of claim 43, wherein the disc is a thoracic disc.

56. The method of claim 43, wherein the disc is a cervical disc.

57. The method of claim 43, wherein a contrast agent is injected either before, with, or after the fibrinogen solution and the activating solution the fibrin sealant has been injected.

58. The method of claim 43, wherein a local anesthetic is injected into the disc.

59. The method of claim 43, wherein the fluid delivery tube is a bilumen catheter.

60. The method of claim 43, wherein the fluid delivery tube is a trilumen catheter.

61. A kit, comprising:

a sealant, and a apparatus for injecting sealant into a human disc, wherein the apparatus is equipped with a fluid delivery tube and an introducer needle, wherein fluid delivery tube has a tip and 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.

62. The kit of claim 61, wherein the apparatus includes a pressure monitor.

63. The kit of claim 61, wherein the sealant is fibrin sealant.

64. The kit of claim 61, wherein the sealant is fibrin sealant and wherein the kit comprises an activating compound for the fibrin sealant, wherein the activating compound is thrombin.

65. The kit of claim 61, further comprising calcium ions.

66. The kit of claim 61, further comprising contrast media.

67. The kit of claim 61, further comprising an additive is provided with the fibrinogen and the activating compound, 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;

tumor necrosis factors;

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;

oxygen-containing components;

enzymes;

melatonin;

vitamins;

nutrients; and

combinations thereof.

68. The kit of claim 61, wherein the biologic sealant is fibrin sealant comprising fibrinogen and an activating compound, and wherein the activating compound is thrombin, and wherein the fibrinogen and thrombin are in a freeze-dried state.

69. The kit of claim 61, further comprising an introducer needle.

70. The kit of claim 61, wherein at least one additive is a local anesthetic.

71. A process for forming a kit, comprising:

providing a biologic sealant, and a biologic sealant apparatus for injecting fibrin sealant into a human disc, wherein the apparatus is equipped with a fluid delivery tube and an introducer needle, wherein fluid delivery tube has a tip and 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.

72. The process of claim 71, wherein the apparatus includes a pressure monitor.

73. A method of manufacturing an apparatus for injecting biologic sealant into a human disc, comprising:

providing an at least two fluid reservoirs,

providing an introducer needle having a distal tip that is in fluid communication with at least one reservoir,

providing a fluid delivery tube that is in fluid communication with a second reservoir, and

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 is configured so that the tip of the fluid delivery tube does not extend past the distal tip of the introducer needle during use.

74. The method of claim 73, wherein the fluid delivery tube is a needle.

75. The method of claim 73, wherein the fluid delivery tube is a catheter.

76. The method of claim 73, wherein the fluid delivery tube is integral with connector.

77. The method of claim 73, wherein the fluid delivery tube couples to a first reservoir of the at least two reservoirs.

78. The method of claim 73, wherein a connector provides a passage for fluid communication.

79. The method of claim 73, 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.

80. The method of claim 73, wherein the introducer needle couples to the at least one fluid reservoir by a luer fitting.

81. The method of claim 73, wherein at least two reservoirs constitute a multi-barrel syringe.

82. The method of claim 73, wherein the fluid delivery tube does not protrude out the end of the introducer needle.

83. The method of claim 73, 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 distal tip of the introducer needle.

84. The method of claim 73, 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.

85. The method of claim 73, 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.

86. The method of claim 73, wherein introducer needle has a gauge in the range of 18 to 22.

87. The method of claim 73, wherein apparatus is handheld.

88. The method of claim 73, 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.

89. The method of claim 73, 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.