Methods And Apparatus For Electrical Treatment Using Balloon And Electrode

• US 20090259274A1
• Filed: 02/27/2009
• Published: 10/15/2009
• Est. Priority Date: 04/10/2008
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: electroCore, Inc.
• Inventors: Guo, Puyun, Mendez, Steven, Pastena, James R., Simon, Bruce, Dickerson, Richard P., Hu, Hecheng
• Granted Patent: US 8,401,650 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/0519 Endotracheal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

The present invention provides systems, apparatus and methods for selectively applying electrical energy to body tissue. A device is provided having an enclosure within an outer wall formed from an electrically-permeable material to allow for electrical energy to pass from the interior of the enclosure through the outer wall. The device further includes an electrode positioned within the interior of the enclosure and a fluid passage coupled to the enclosure for delivery of an electrically conductive fluid into the interior of the enclosure such that the electrically conductive fluid couples the electrode with the electrically-permeable section of the outer wall. The conductive fluid allows for the passage of electrical energy from the electrode through the fluid and the outer wall of the enclosure for treatment of tissue on or in a patient. In this manner, the electrode does not directly contact the tissue of the patient, which reduces the potential for collateral tissue damage or necrosis and/or excessive electric fields in the tissue.

Claims

1. A device for delivering energy to a mammal, comprising:

an enclosure having an outer wall surrounding an interior, the outer wall having at least one section that is formed from an electrically-permeable material;

an electrode within the interior of the enclosure spaced from the electrically-permeable section of the outer wall; and

a fluid passage coupled to the interior of the enclosure for delivery of an electrically conductive fluid into said interior such that the electrically conductive fluid couples the electrode with the electrically-permeable section of the outer wall.

2. The device of claim 1 wherein the enclosure is expandable.

3. The device of claim 1 wherein the enclosure is a balloon.

4. The device of claim 3 wherein the balloon is movable between a deflated position for introduction into a patient and an inflated position for contacting said tissue within the patient.

5. The device of claim 1 wherein the electrode is substantially centrally located within the enclosure.

6. The device of claim 1 wherein said section of the outer wall is formed of an ion-permeable material.

7. The device of claim 1 wherein the outer wall of the enclosure is entirely formed from an electrically-permeable material.

8. The device of claim 1 wherein said section of the outer wall is formed from a fluidly-permeable material.

9. The device of claim 1 wherein the outer wall is formed of a material substantially conformable to tissue.

10. The device of claim 3 wherein the balloon is elastic.

11. The device of claim 1 further comprising a nasogastral (NG) tube having an internal passageway and an external surface, wherein the electrode is coupled to the external surface of the NG tube within the interior of the enclosure.

12. The device of claim 11 further comprising a conductor extending through the internal passageway of the NG tube and electrically coupled to the electrode.

13. The device of claim 1, wherein the electrode is generally cylindrically-shaped.

14. The device of claim 1, wherein electrical properties of the electrode, the electrically conductive fluid, and the electrically-permeable material of the enclosure are such that a resistance through the electrode, the electrically conductive fluid, and the electrically-permeable material of the enclosure is no more than about 200 Ohms.

15. The device of claim 1, wherein the electrically conductive fluid is about 5% saline solution.

16. The device of claim 1, further comprising an electrical signal generator operating to apply at least one electrical signal to the electrode such that, when the enclosure is positioned in an esophagus of the mammal, an electromagnetic field emanates from the electrode to at least one of nerves and muscles in a vicinity of the esophagus of the mammal.

17. The device of claim 16, further comprising a return electrode adapted for contact with the mammal, wherein the electrode and the return electrode are adapted such that the electromagnetic field emanating from the electrode is in a substantially radial pattern.

18. The device of claim 1, wherein the enclosure is sized and shaped such that it operates to:

(i) slide, in a deflated state, past a cricoid cartilage of the mammal, and (ii) seat, when in an inflated state, when slid back toward the cricoid cartilage.

19. The device of claim 16 wherein the electrical signal generator operates such that the at least one electrical signal is of a frequency between about 1 Hz to 3000 Hz, a pulse duration of between about 10-1000 us, and an amplitude of between about 1-20 volts.

20. A system for delivering energy to a mammal comprising:

a source of electrical energy;

an enclosure coupled to the source of electrical energy and having an outer wall surrounding an interior;

the outer wall having at least one section that is formed of an electrically-permeable material; and

a fluid delivery device fluidly coupled to the interior of the enclosure for delivering electrically conductive fluid to said interior such that the electrically-permeable section of the outer wall is electrically coupled to the electrical energy source.

21. The system of claim 20 further comprising an introducer having an internal passageway and an external surface within the interior of the enclosure such that when the enclosure is inflated with conductive fluid, the fluid acts as an electrode within the interior of the enclosure.

22. The system of claim 21 wherein the introducer is an NG tube comprising a conductor extending through the internal passageway of the NG tube to provide a path for electrical current to flow to the fluid within the balloon.

23. The system of claim 20 wherein the enclosure is a balloon movable between a deflated position for introduction into a patient and an inflated position for contacting tissue within the patient.

24. The system of claim 23 wherein the electrode is substantially centrally located within the balloon in the inflated position.

25. The system of claim 23 wherein said section is fluidly-permeable such that the electrically conductive fluid wets an outer surface of said section when the balloon is in the inflated position.

26. A method of treating an ailment comprising:

contacting a tissue of a mammal with an electrically-permeable portion of an outer wall of an enclosure;

applying electrical energy to an electrode within the enclosure; and

delivering electrically conductive fluid into the enclosure such that the conductive fluid electrically couples the electrode with the electrically-permeable portion of the outer wall of the enclosure.

27. The method of claim 26 wherein the contacting step comprises expanding the enclosure from a deflated position to an inflated position.

28. The method of claim 27 wherein the expanding step is carried out by delivering the electrically conductive fluid into an interior of the enclosure.

29. The method of claim 26 further comprising inflating the enclosure with the electrically conductive fluid such that the electrode is substantially centrally located within an interior volume of the enclosure.

30. The method of claim 26 wherein the applying step is carried out by applying at least one electrical signal to the electrode such that an electromagnetic field emanates from the electrode to at least one of nerves and muscles of the mammal.

31. The method of claim 30 further comprising modulating nerve signals within the vagus nerve of the mammal.

32. The method of claim 30 further comprising reducing the magnitude of constriction of bronchial smooth muscle of the mammal during the applying step.

33. The method of claim 30 further comprising increasing a blood pressure of the mammal during the applying step.

34. The method of claim 30 further comprising decreasing a blood pressure of the mammal during the applying step.

35. The method of claim 26, further comprising contacting a return electrode to an external portion of the mammal and emanating an electromagnetic field from the electrode through the tissue in a substantially radial pattern.

36. The method of claim 26 further comprising introducing the enclosure into an interior portion of the mammal.

37. The method of claim 36 wherein the introducing step comprises inserting the enclosure in a deflated state past a cricoid cartilage of the mammal, inflating the enclosure, and extracting the enclosure back toward the cricoid cartilage until it seats.

38. The method of claim 26 wherein electrical properties of the electrode, the conductive fluid, and the electrically-permeable portion of the enclosure are such that a resistance through the electrode, the conductive fluid, and electrically-permeable portion of the enclosure is no more than about 200 Ohms.

39. The method of claim 26 wherein the applying step is carried out by applying an electrical signal to the electrode of a frequency between about 1 Hz to 3000 Hz, a pulse duration of between about 10-1000 us, and an amplitude of between about 1-20 volts.

40. The method of claim 26 further comprising evacuating the conductive fluid from the interior of the enclosure.

41. The method of claim 40 wherein the evacuating step is carried out simultaneously with the delivering step.

42. The method of claim 26 further comprising delivering an agent into the interior of the balloon with the conductive fluid such that the agent passes through the outer wall of the enclosure to the tissue.

43. The method of claim 42 wherein the agent is an anti-cancer drug.

44. The method of claim 42 wherein the agent is an antiseptic drug, such as silver.

45. A device for delivering energy to a mammal comprising:

a first enclosure having an outer wall surrounding an interior;

a second enclosure having an outer wall surrounding an interior;

a first electrode located within the interior of the first enclosure and spaced from the outer wall of the first enclosure;

a second electrode located within the interior of the second enclosure and spaced from the outer wall of the second enclosure; and

first and second fluid passages coupled to the interiors of the first and second enclosures, respectively, for delivery of an electrically conductive fluid to the interiors of the first and second enclosures, respectively, such that each of the first and second electrodes are electrically coupled to each of the outer walls of the first and second enclosures through the electrically conductive fluid.

46. The device of claim 45 further comprising an electrical signal generator operating to apply a voltage to the first and second electrodes such that electric current passes from the first electrode to the second electrode through tissue of the mammal.

47. The device of claim 45 wherein the outer walls of the first and second enclosures each have at least one section that is formed from an electrically-permeable material.

49. The device of claim 45 wherein the first and second electrodes are substantially centrally located within the first and second enclosures, respectively, in the inflated position.

48. The device of 45 wherein the first and second enclosures are balloons movable between a deflated position for introduction into a patient and an inflated position for contacting tissue within the patient.

50. The device of claim 48 wherein the first and second balloons are arranged such that an electric field created by the voltage is substantially parallel to an axis of a target tissue in the patient.

51. A method of treating an ailment comprising:

positioning one or more electrodes adjacent to or in contact with a tissue structure having a longitudinal axis within or on a patient'"'"'s body; and

applying an electric field to the electrode(s) such that the electric field is substantially parallel to the longitudinal axis of the tissue structure.

52. The method of claim 51 wherein the tissue structure is a nerve fiber.

53. The method of claim 51 wherein the positioning step comprises positioning first and second balloons adjacent to or in contact with the tissue structure, said first and second balloons having first and second electrodes located within an interior of the first and second balloons, respectively.

54. The method of claim 53 further comprising inflating said first and second balloons such that an outer surface of the balloons is adjacent to or in contact with the tissue structure.

55. The method of claim 54 wherein said inflation step is carried out by delivering electrically conductive fluid to the interior of the first and second balloons.

56. The method of claim 51 wherein the applying step is carried out by applying an electric signal across the first and second electrodes such that the electric field is substantially parallel to the tissue structure.