Methods and apparatus for electrical stimulation treatment using esophageal balloon and electrode

• US 8,209,034 B2
• Filed: 12/18/2008
• Issued: 06/26/2012
• Est. Priority Date: 12/18/2008
• Status: Expired due to Fees

• Current Assignee: electroCore, Inc.
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce, Mendez, Steven, Hu, Hecheng, Dickerson, Richard P., Pastena, James R.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Wieland, Robert
• Application Number:
  US12/338,191
• Publication Number:
  US 20100160996A1
• Time in Patent Office: 1,286 Days
• Field of Search: 607/124, 607/116, 600/41, 600/547, 128/898
• US Class Current: 607/124
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

Methods and apparatus for treating ailments provide for: inserting a balloon-electrode device into an esophagus of a mammal, the balloon-electrode device including: (i) a nasogastral (NG) having an internal passageway and an external surface, (ii) at least one electrode coupled to the external surface of the NG tube, (iii) a conductor extending through the internal passageway of the NG tube and electrically connecting to the electrode, and (iv) a balloon surrounding the electrode and a portion of the NG tube; inflating the balloon with fluid such that the electrode is substantially centrally located within an interior volume of the balloon; and applying at least one electrical signal to the electrode via the conductor such that an electro-magnetic field emanates from the electrode to at least one of nerves and muscles of the mammal.

Claims

1. A device for delivering an electromagnetic field to a mammal, comprising:

a nasogastral (NG) tube having an internal passageway and an external surface;

at least one electrode coupled to the external surface of the NG tube;

a conductor extending through the internal passageway of the NG tube and electrically coupled to the electrode; and

a balloon surrounding the electrode and a portion of the NG tube such that when the balloon is inflated with fluid, the electrode is substantially centrally located within an interior volume of the balloon.

2. The device of claim 1, wherein the at least one electrode is generally cylindrically-shaped and extends around the external surface of the NG tube.

3. The device of claim 2, wherein at least one of:

(i) the at least one electrode is between about 1.0-1.5 mm long;

(ii) an outside diameter of the at least one electrode is between about 2.6-2.85 mm; and

an inside diameter of the at least one electrode is between about 2.5-2.75 mm.

4. The device of claim 1, wherein the NG tube includes a first aperture through which the conductor passes from the internal passageway to the at least one electrode.

5. The device of claim 4, wherein the NG tube includes at least one of second and third apertures extending from the internal passageway to the external surface, and through which the fluid may pass to inflate and deflate the balloon.

6. The device of claim 5, wherein the second and third apertures are disposed at proximal and distal ends of the balloon, respectively, and the first aperture is located between the second and third apertures.

7. The device of claim 1, wherein the balloon is formed from an ion-permeable material.

8. The device of claim 1, wherein at least one of:

(i) a length of the balloon is between about 1-3 cm;

(ii) a diameter of the balloon when inflated is between about 1.5-4.0 cm; and

(iii) a fluid pressure within the balloon is between about 1-3 pounds per square inch when inflated.

9. The device of claim 1, wherein electrical properties of the electrode, the fluid, and the material of the balloon are such that a resistance through the electrode, the fluid, and the material of the balloon is no more than about 200 Ohms.

10. The device of claim 9, wherein the fluid is about 5% saline solution.

11. The device of claim 1, further comprising an electrical signal generator operating to apply at least one electrical signal to the conductor such that, when the inflated balloon and electrode combination is positioned in an esophagus of the mammal, an electro-magnetic field emanates from the electrode to at least one of nerves and muscles in a vicinity of the esophagus of the mammal.

12. The device of claim 1, wherein at least one of:

the electro-magnetic field emanates from the electrode to at least a vagus nerve of the mammal; and

the at least one electrical signal, in combination with electrical characteristics of the electrode, the fluid, and the material of the balloon, are such that at least one of;

(i) a magnitude of constriction of bronchial smooth muscle of the mammal is reduced, (ii) a blood pressure of the mammal is either reduced or increased, (iii) epilepsy, (iv) depression, (v) obesity, and (vi) any other ailment affected by vagus nerve transmissions.

13. The device of claim 11, further comprising a return electrode, which when applied to the mammal, the electro-magnetic field emanating from the electrode is a substantially radial pattern.

14. The device of claim 11, wherein the balloon 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.

15. The device of claim 11, wherein at least one of:

electrical properties of the electrode, the fluid, and the material of the balloon are such that a resistance through the electrode, the fluid, and the material of the balloon is no more than about 200 Ohms; and

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.

16. The device of claim 15, wherein the at least one electrical signal is of a frequency between about 15 Hz to 35 Hz.

17. The device of claim 16, wherein the at least one electrical signal is of a frequency of about 25 Hz.

18. The device of claim 15, wherein the at least one electrical signal has a pulsed on-time of between about 50 to 1000 microseconds.

19. The device of claim 18, wherein the at least one electrical signal has a pulsed on-time of between about 100 to 300 microseconds.

20. The device of claim 18, wherein the at least one electrical signal has a pulsed on-time of about 200 microseconds.

21. The device of claim 15, wherein the at least one electrical signal has an amplitude of about 5-15 volts.

22. The device of claim 15, wherein the at least one electrical signal has an amplitude of about 12 volts.

23. The device of claim 15, wherein the at least one electrical signal is one or more of a full or partial sinusoid, a square wave, a rectangular wave, and triangle wave.

24. A device for delivering an electro-magnetic field to a mammal, comprising:

a nasogastral (NG) tube having an internal passageway and an external surface; and

a balloon surrounding a portion of the NG tube such that when the balloon is inflated with conductive fluid, the fluid acts as an electrode within an interior volume of the balloon.

25. The device of claim 24, further comprising a conductive fluid extending through the internal passageway of the NG tube to provide a path for electrical current to flow to the fluid within the balloon.

26. The device of claim 24, further 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.

27. A method of treating an ailment, comprising:

inserting a balloon-electrode device into an esophagus of a mammal, the balloon-electrode device including;

a nasogastral (NG) having an internal passageway and an external surface,

at least one electrode coupled to the external surface of the NG tube,

a conductor extending through the internal passageway of the NG tube and electrically connecting to the electrode, and

a balloon surrounding the electrode and a portion of the NG tube;

inflating the balloon with fluid such that the electrode is substantially centrally located within an interior volume of the balloon; and

applying at least one electrical signal to the electrode via the conductor such that an electro-magnetic field emanates from the electrode to at least one of nerves and muscles the mammal.

28. The method of claim 27, wherein at least one of:

applying the least one electrical signal to the electrode via the conductor results in an electro-magnetic field emanating from the electrode to at least a vagus nerve of the mammal; and

the at least one electrical signal, in combination with electrical characteristics of the electrode, the fluid, and the material of the balloon, are such that at least one of;

(i) a magnitude of constriction of bronchial smooth muscle of the mammal is reduced, (ii) a blood pressure of the mammal is either reduced or increased, (iii) epilepsy, (iv) depression, (v) obesity, and (vi) any other ailment affected by vagus nerve transmissions.

29. The method of claim 27, further comprising applying a return electrode to the mammal such that the electro-magnetic field emanating from the electrode is a substantially radial pattern.

30. The method of claim 27, further comprising applying a return electrode to an external portion of the mammal.

31. The method of claim 30, wherein the external portion of the mammal is at least one of the mammal'"'"'s upper-back, the mammal'"'"'s chest, and the mammal'"'"'s stomach.

32. The method of claim 27, wherein the step of inserting the balloon-electrode device and inflating the balloon includes:

inserting the balloon-electrode device in a deflated state past a cricoid cartilage of the mammal, inflating the balloon, and extracting the balloon-electrode device back toward the cricoid cartilage until it seats.

33. The method of claim 27, wherein at least one of:

electrical properties of the electrode, the fluid, and the material of the balloon are such that a resistance through the electrode, the fluid, and the material of the balloon is no more than about 200 Ohms; and

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.

34. The method of claim 33, wherein the at least one electrical signal is of a frequency between about 15 Hz to 35 Hz.

35. The method of claim 34, wherein the at least one electrical signal is of a frequency of about 25 Hz.

36. The method of claim 33, wherein the at least one electrical signal has a pulsed on-time of between about 50 to 1000 microseconds.

37. The method of claim 36, wherein the at least one electrical signal has a pulsed on-time of between about 100 to 300 microseconds.

38. The method of claim 36, wherein the at least one electrical signal has a pulsed on-time of about 200 microseconds.

39. The method of claim 33, wherein the at least one electrical signal has an amplitude of about 5-15 volts.

40. The method of claim 33, wherein the at least one electrical signal has an amplitude of about 12 volts.

41. The method of claim 33, wherein the at least one electrical signal is one or more of a full or partial sinusoid, a square wave, a rectangular wave, and triangle wave.