Integral high frequency electrode

• US 7,862,563 B1
• Filed: 07/18/2006
• Issued: 01/04/2011
• Est. Priority Date: 02/18/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Eric R. Cosman, Eric R. Cosman Jr
• Inventors: Cosman, Eric R. Jr., Cosman, Eric R.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US11/488,153
• Time in Patent Office: 1,631 Days
• Field of Search: 606/41, 606 48- 50
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

A method and apparatus for the application of an electrical signal to neural tissue and other target tissue in the living body.

Claims

1. A unitized high frequency electrode system comprising:

a cannula having a proximal end and a distal end, the distal end comprising an uninsulated electrode tip, and the cannula being rigidly adapted to enable self-supported penetration of skin and tissue so that the uninsulated electrode tip can be positioned in a target tissue;

a unitized flexible leader having an inner lumen, the unitized flexible leader being inseparably connected to the proximal end of the cannula;

a high frequency electrical connection carried, at least in part, in the unitized flexible leader to the proximal end of the cannula where the high frequency electrical connection is inseparably connected to the proximal end of the cannula and configured so that a high frequency signal connected to the high frequency electrical connection is connected to the uninsulated electrode tip;

a temperature connection and a temperature sensor, the temperature sensor configured to be in thermal contact with the uninsulated electrode tip, the temperature connection being carried, at least in part, in the unitized flexible leader to the proximal end of the cannula and being connected to the temperature sensor;

wherein the temperature connection is configured so that a temperature readout apparatus connected to the temperature connection can read the temperature at the temperature sensor;

whereby, the high frequency electrode system, when inserted into the living body so that the uninsulated electrode tip is positioned in the tissue, enables the treatment of the tissue by applying the high frequency signal to the tissue while sensing the temperature of the tissue adjacent to the uninsulated electrode tip.

2. The system of claim 1, wherein the high frequency electrical connection includes a flexible high frequency portion.

3. The system of claim 1, wherein the temperature connection includes a flexible temperature portion that is inseparably connected to the proximal end of the cannula.

4. The system of claim 1, wherein the tissue is near a spinal nerve.

5. The system of claim 1, wherein the tissue is near spinal bones.

6. The system of claim 1, wherein the uninsulated electrode tip comprises a metal tubing at its exterior surface.

7. The system of claim 6, wherein the temperature sensor is in thermal contact with the metal tubing to enable rapid temperature measurement of the target tissue adjacent to the uninsulated electrode tip.

8. The system of claim 6, wherein the metal tubing includes a diameter of at least 0.4 millimeters.

9. The system of claim 1, wherein the flexible leader includes an injection port, and the cannula further comprises a fluid channel through the cannula and a fluid exit at the distal end of the cannula, whereby fluid can be injected into the injection port and pass through the fluid channel and out of the cannula through the fluid exit.

10. The system of claim 9, wherein the injection port further comprises a flexible fluid port connection.

11. The system of claim 1, wherein the flexible leader portion comprises a distal leader end and a proximal leader end, the distal leader end being connected to the proximal end of the cannula and the proximal leader end being connected to a unitized hub that is adapted to connect to a high frequency generator.

12. The system of claim 11, wherein the flexible leader portion comprises a single flexible tubing, the high frequency electrical connection comprises at least one high frequency electrical wire, the temperature connection comprising at least one temperature wire, and the cannula further comprising a fluid channel through the cannula and a fluid exit channel near the distal end of the cannula, the inner lumen being fluidly connected to the fluid channel in the cannula, and wherein the system further comprises an injection port, whereby fluid injected into the injection port passes through the inner lumen, through the fluid channel, and out of the cannula through the fluid exit channel.

13. The system of claim 12, wherein the cannula comprising a metal tubing, and the flexible leader comprises a single flexible plastic tubing, the inner lumen being a single lumen within the single flexible plastic tubing, the distal leader end being connected to the metal tubing, and the proximal leader end being connected to the hub connection and the injection port.

14. The system of claim 1, wherein the temperature connection comprises a wire that runs in part through the interior space of the cannula and connects to the temperature sensor.

15. The system of claim 1, wherein the proximal end is configured to be inaccessible to port-injection of fluid.

16. The system of claim 1, wherein the proximal end is closed to injection of fluids into the interior space of the cannula.

17. The system of claim 1, wherein the proximal end is sealed to the passage of fluids through the interior space of the cannula.

18. The system of claim 1, wherein the distal end of the cannula includes a curved portion to improve the positioning of the uninsulated electrode tip near the target tissue.

19. The system of claim 1, wherein the cannula comprises a metal tubing.

20. The system of claim 1, wherein the uninsulated electrode tip includes a sharpened tip end.

21. The system of claim 20, wherein the sharpened tip end comprises a tri-cut beveled point.

22. The system of claim 1, wherein the temperature sensor comprises a constantan wire that passes through the an interior space of the cannula and is fused electrically to the wall of the metal tubing at the uninsulated electrode tip.

23. The system of claim 1, wherein the temperature sensor comprises a copper and a constantan wire electrically fused to a thermocouple junction.

24. The system of claim 1, wherein the system further includes a radio opaque material inside a lumen of the cannula near the uninsulated electrode tip to increase the contrast in an x-ray imaging of the electrode.

25. The system of claim 19, wherein a lumen at a beveled portion of the metal tubing at the distal end of the cannula is occluded.

26. The system of claim 25, wherein the lumen is occluded by an epoxy.

27. The system of claim 19, wherein the distal end includes a sharpened distal tip that is not fully enclosed by metal.

28. The system of claim 27, wherein the sharpened distal tip comprises a beveled portion of the metal tubing.

29. The system of claim 19, wherein a distal end of the metal tubing comprises a tapered forming of the metal tubing that converges to a tissue piercing tip end.

30. The system of claim 19, wherein the cannula is adapted so that fluid can be injected into the proximal end, through the cannula, and out of the distal end.

31. The system of claim 19, wherein the uninsulated electrode tip comprises at least a portion of the distal end of the metal tubing.

32. The system of claim 20, wherein the sharpened tip end comprises a bevel.

33. The system of claim 19, wherein the uninsulated electrode tip includes a sharpened tip end comprising a beveled portion of the metal tubing.

34. The system of claim 19, wherein the uninsulated electrode tip includes a sharpened tip end comprising at least in part a shaped portion of the distal end of the metal tubing.

35. The system of claim 34, wherein the shaped portion of the distal end of the metal tubing comprises a tapered form of the metal tubing that converges to a tissue piercing tip end.

36. The system of claim 1, further comprising a flexible fluid carrying portion within the cannula.

37. The system of claim 1, wherein the unitized flexible leader comprising a single flexible tubing having at least one lumen channel within the single flexible tubing, the unitized flexible leader having a leader proximal end and a leader distal end, the leader distal end being connected to the proximal end of the cannula so that the at least one lumen channel is connected to the proximal end of the cannula and an injection port that is connected to the leader proximal end and configured so that a fluid injected into the injection port passes through at least one lumen channel, through a proximal opening at the proximal end of the cannula, through a cannula lumen, and out of the cannula lumen through a distal opening at the distal end of the cannula;

and wherein the cannula lumen within the cannula connects the proximal opening to the distal opening.

38. The system of claim 37, wherein the leader distal end is inseparably connected to the proximal end of the cannula.

39. The system of claim 37, wherein the electrical connection is connected to the leader proximal end and is adapted to connect to a high frequency generator.

40. The system of claim 37, wherein the single flexible tubing further comprises a plastic tubing having an inner lumen configured so that fluid injected into the injection port passes through the inner lumen and through the cannula lumen to exit the cannula through the distal opening.

41. The system of claim 40, wherein the temperature connection and the high frequency electrical connection comprise wires that pass within the inner lumen of the plastic tubing.

42. The system of claim 40, wherein the high frequency electrical connection and the temperature connection further comprises wires that are at least in part imbedded into the wall of the single flexible tubing.

43. The system of claim 37, wherein the single flexible tubing further comprises a plastic tubing having a first inner lumen configured so that the fluid injected into the injection port passes through the inner lumen and through the cannula lumen to exit the cannula through the distal opening, and a second inner lumen which contains wires that are a part of the high frequency electrical connection and the temperature connection.

44. The system of claim 37, wherein the single flexible tubing between the leader distal end and the position of the injection port on the single flexible tubing has a length in the range of about 0.2 to 2 inches.

45. The system of claim 37, wherein the single flexible tubing between the leader distal end and the position of the injection port on the single flexible tubing has a length in the range of about 2 to 12 inches.

46. The system of claim 37, wherein the single flexible tubing between the leader distal end and the position of the injection port on the single flexible tubing has a length in the range of about 12 to 20 inches.

47. The system of claim 37, wherein the single flexible tubing between the leader distal end and the position of the injection port on the single flexible tubing has a length in the range of about 20 to 40 inches.

48. The system of claim 37, wherein the single flexible tubing between the leader distal end and the position of the injection port on the single flexible tubing has a length in the range of about 40 to 400 inches.

49. The system of claim 37, wherein the cannula further comprises a metal tubing, and wherein the single flexible plastic tubing has a single lumen, the leader distal end being connected to the metal tubing, and the leader proximal end being connected to an electrical hub connection that connects the high frequency electrical connections and the temperature connection to a high frequency generator, and the leader proximal end connects the tubing lumen to the injection port.

50. The system of claim 37, wherein the leader proximal end connects to a junction element that comprises a fluid connection to the injection port and an electrical connection that connects the high frequency electrical connection and the temperature connection to a high frequency generator.

51. The system of claim 50, wherein the junction element further comprises having a branch junction with a fluid branch that connects to the injection port and an electrical branch that connects to the high frequency electrical connection and the temperature connection.

52. The system of claim 50, wherein the injection port further comprises a luer fitting.

53. The system of claim 50, wherein the injection port further comprises a fluid coupling fitting.

54. The system of claim 1, further comprising a single flexible leader having a leader proximal end and a leader distal end, the leader distal end being connected to the proximal end and an non-flexible injection port that is rigidly connected to the proximal end and configured so that fluid injected into the injection port passes through the proximal opening, through the cannula lumen, and out of the cannula lumen through the distal opening.

55. The system of claim 54, further comprising a hub that is rigidly connected to the proximal end of the cannula, the hub having a rigidly connected injection port, and the single flexible leader is connected to the hub.

56. The system of claim 54, wherein the single flexible leader comprises an electrical hub connection at the leader proximal end, the electrical hub connection configured to connect the high frequency electrically connection and the temperature connection to a high frequency generator.

57. The system of claim 54, wherein the single flexible leader from the position of the connection between the leader distal end and the proximal end and the position of the electrically leader hub has a length in the range of about 0.2 to 2 inches.

58. The system of claim 54, wherein the single flexible leader from the position of the connection between the leader distal end and the proximal end and the position of the electrically leader hub has a length in the range of about 2 to 12 inches.

59. The system of claim 54, wherein the single flexible leader from the position of the connection between the leader distal end and the proximal end and the position of the electrically leader hub has a length in the range of about 12 to 20 inches.

60. The system of claim 54, wherein the single flexible leader from the position of the connection between the leader distal end and the proximal end and the position of the electrically leader hub has a length in the range of about 20 to 40 inches.

61. The system of claim 54, wherein the single flexible leader from the position of the connection between the leader distal end and the proximal end and the position of the electrically leader hub has a length in the range of about 40 to 400 inches.

62. An injectable high frequency electrode system comprising:

a cannula comprising a metal tubing, configured to be inserted into a patient'"'"'s body and having a proximal end, a distal end, a cannula channel and an exit out of the cannula channel on the distal end of the cannula, wherein the distal end comprising an uninsulated electrode tip;

a fluid port connection inseparably connected to the proximal end configured so that fluid injected into the fluid port will pass through the cannula and exit out of the cannula near the distal end;

a high frequency electrical connection located at least in part at the proximal end and configured so that a high frequency signal applied to the high frequency electrical connection will be connected to the uninsulated electrode tip; and

a temperature connection and a temperature sensor, the temperature sensor configured to be built into the uninsulated electrode tip to sense the temperature at the uninsulated electrode tip;

wherein the fluid port connection comprises a flexible fluid carrying portion containing at least one single channel lumen, the single channel lumen being fluidly connected to the cannula and the fluid port connection so that fluid injected into the fluid port connection will pass through the single channel lumen and through the cannula to exit out of the cannula near the distal end, the single channel lumen housing at least a portion of the high frequency electrical connection.

63. The system of claim 62, wherein the uninsulated electrode tip comprises at least a portion of the distal end of the metal tubing.

64. The system of claim 62, wherein the system further comprises a flexible portion that is inseparably connected to the proximal end of the cannula that includes the high frequency electrical connection and the temperature connection.

65. The system of claim 62, wherein the temperature connection comprises a wire that runs in part through an interior space of the cannula and connects to the temperature sensor.

66. The system of claim 62, wherein the uninsulated electrode tip includes a sharpened tip end.

67. The system of claim 66, wherein the sharpened tip end comprises a bevel.

68. The system of claim 66, wherein the sharpened tip end comprises a beveled portion of the metal tubing.

69. The system of claim 66, wherein the sharpened tip end comprises at least in part a shaped portion of the distal end of the metal tubing.

70. The system of claim 69, wherein the shaped portion of the distal end of the metal tubing comprises a tapered forming of the metal tubing that converges to a tissue piercing tip end.

71. The system of claim 62, wherein the uninsulated electrode tip comprises a metal tubing at its exterior surface, and the temperature sensor is in thermal contact with the metal tubing to enable rapid temperature measurement of a target tissue adjacent to the uninsulated electrode tip.

72. The system of claim 71, wherein the metal tubing includes a diameter of at least 0.4 millimeters.

73. The system of claim 62, wherein the system includes an inseparable injection port connected to the proximal end of the cannula, whereby fluid can be injected into the injection port and pass through the cannula channel and out of the exit of the cannula channel.

74. The system of claim 73, wherein the injection port comprises a flexible fluid carrying portion.

75. The system of claim 74, wherein the flexible fluid carrying portion comprises a flexible tubing portion containing at least one single channel lumen, the single channel lumen being fluidly connected to the cannula channel and the injection port so that fluid injected into the injection port will pass through the single channel lumen and through the fluid channel to exit from the fluid channel exit, the single channel lumen housing at least a portion of the temperature connection.

76. The system of claim 64, wherein the system further comprises a unitized hub connection at the proximal end that is adapted to connect to a high frequency generator.

77. The system of claim 62, wherein the temperature connection comprises a wire that runs in part through an interior space of the cannula and connects to the temperature sensor.

78. The system of claim 62, wherein the distal end of the cannula includes a curved portion to improve the positioning of the uninsulated electrode tip near a target tissue.

79. The system of claim 62, the single channel lumen further housing at least a portion of the temperature connection.