Electrical stimulation treatment of bronchial constriction

• US 20070106339A1
• Filed: 11/01/2006
• Published: 05/10/2007
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: electroCore, Inc.
• Inventors: Mendez, Steven, Ross, Arthur, Errico, Joseph, Pastena, James, Hu, Hecheng
• Granted Patent: US 7,747,324 B2
• Time in Patent Office: Days
• US Class Current: 607/42
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Methods and devices for treating bronchial constriction related to asthma and anaphylaxis wherein the treatment includes providing an electrical impulse to a selected region of the vagus nerve and/or the lungs of a patient suffering from bronchial constriction.

Claims

1. A method of treating bronchial constriction associated with asthma or anaphylaxis comprising applying at least one electrical impulse to a selected region of the vagus nerve of a mammal in need of relief of bronchial smooth muscle constriction whereby the magnitude of constriction of the smooth muscle is reduced.

2. The method set forth in claim 1 wherein the at least one selected region comprises an anterior pulmonary plexus.

3. The method set forth in claim 1 wherein the at least one selected region comprises a posterior pulmonary plexus.

4. The method set forth in claim 1 wherein the at least one selected region comprises a region of the vagus nerve proximal to the cardiac branch of the vagus nerve.

5. The method set forth in claim 1 wherein the at least one selected region comprises a region of the vagus nerve proximal to the pulmonary branch of the vagus nerve.

6. A device for the treatment of bronchial constriction associated with anaphylactic shock or asthma comprising:

an electrical impulse generator;

a power source coupled to the electrical impulse generator;

a control unit in communication with the electrical impulse generator and coupled to the power source;

electrodes coupled to the electrical impulse generator; and

electrode leads coupled to the electrodes for attachment to one or more selected regions of a vagus nerve of a mammal;

wherein the control unit modulates the electrical impulse generator for generation of a signal suitable for amelioration of the bronchial constriction when the signal is applied via the electrode leads to the vagus nerve.

7. The device of claim 6, wherein the electrode leads have wide contact areas.

8. A method of treating bronchial constriction associated with anaphylactic shock or asthma, comprising applying at least one electrical impulse to one or more selected regions of the vagus nerve of a mammal in need of relief of bronchial constriction.

9. The method of claim 8, further comprising:

implanting one or more electrodes to the selected regions of the vagus nerve; and

applying one or more electrical stimulation signals to the electrodes to produce the at least one electrical impulse,

wherein the one or more electrical stimulation signals are of a frequency between about 1 Hz to 3000 Hz, and an amplitude of between about 1-6 volts.

10. The method of claim 9, wherein the one or more electrical stimulation signals are of a frequency between about 750 Hz to 1250 Hz.

11. The method of claim 9, wherein the one or more electrical stimulation signals are of a frequency between about 15 Hz to 35 Hz.

12. The method of claim 9, wherein the one or more electrical stimulation signals are of an amplitude of between about 0.75 to 1.25 volts.

13. The method of claim 9, wherein the one or more electrical stimulation signals are one or more of a full or partial sinusoid, square wave, rectangular wave, triangle wave.

14. The method of claim 9, wherein the one or more electrical stimulation signals have a pulsed on-time of between about 50 to 500 microseconds.

15. The method of claim 9, wherein the one or more electrical stimulation signals have a frequency of about 25 Hz, a pulsed on-time of about 200-400 microseconds, and an amplitude of about 1 volt.

16. The method of claim 9, wherein the one or more electrical stimulation signals have a frequency of about 25 Hz, a pulsed on-time of between about 100 to 400 microseconds, and an amplitude of about 1 volt.

17. The method of claim 16, wherein the pulsed on-time is one of:

about 400 microseconds, about 200 microseconds, and about 100 microseconds.

18. The method of claim 9, further comprising maintaining a polarity of the pulse either positive or negative.

19. The method of claim 18, further comprising alternating the polarity of the pulse to be positive for some periods of the wave and negative for some other periods of the wave.

20. The method of claim 18, further comprising alternating the polarity of the pulse about every second.

21. A method, comprising:

simultaneously monitoring at least one of nerve and muscle electrical activity on respective sides of a target plexus of a patient;

identifying desired electrical activity of at least one of nerves and muscles on both sides of the target plexus based on the monitored activity; and

modulating the electrical activity of the at least one of nerves and muscles on both sides of the target plexus to achieve a therapeutic result.

22. The method of claim 21, wherein the modulation is accomplished using at least one of (i) electrical current to one or more electrodes, and (ii) pharmaceuticals.

23. The method of claim 21, wherein the target plexus is one of the great plexuses.

24. The method of claim 23, wherein the target plexus is the celiac plexus.

25. The method of claim 23, wherein the target plexus is the hepatic plexus.

26. The method of claim 24, wherein the monitoring and modulation of the at least one of nerves and muscles are performed on nerves of the sympathetic or parasympathetic nervous system on one side of the celiac plexus and one or more vagus nerves on the other side of the celiac plexus.

27. The method of claim 26, further comprising:

placing an electrode adjacent to or in communication with at least one ganglion along the sympathetic nerve chain and at least one of monitoring and modulating the at least one ganglion.

28. The method of claim 26, further comprising:

placing an electrode adjacent to or in communication with the celiac plexus and at least one of monitoring and modulating the plexus.

29. The method of claim 21, wherein the modulation is accomplished using electrical current to the one or more electrodes and the method further includes:

adjusting at least one parameter of one or more electrical signals to the electrodes until the physiological disorder has been demonstrably affected, modulated, treated, alleviated, arrested, or ameliorated.

30. The method of claim 21, wherein the step of modulating the electrical activity includes at least one of stimulating and reversibly blocking afferent or efferent signals of nervous and/or muscular tissue.

31. A method of treatment, comprising:

simultaneously monitoring electrical activity of at least two of;

(i) at least one nerve of the sympathetic nervous system, (ii) at least one nerve of the cranial nervous system, and (iii) at least one target plexus associated with the selected nerves of the sympathetic and cranial nervous systems, of a patient;

identifying desired electrical activity of at least one of the monitored nerves on both sides of the target plexus based on the monitored activity; and

modulating the electrical activity of at least one of the monitored nerves on both sides of the target plexus,

wherein the monitoring and modulating steps are directed to the treatment of one or more of;

hyperhydrosis, pain syndromes, intestinal motility disorders, sexual dysfunction, liver disorders, pancreas disorders, heart disorders, pulmonary disorders, gastrointestinal disorders, and biliary disorders.

32. The method of treatment of claim 31, comprising further simultaneously monitoring electrical activity of at least one of:

(i) muscles surrounding or interfacing with pathologically responding tissue, and (ii) any physical state of being that may be associated with the treatment.

33. The method of treatment of claim 31, further comprising creating a stimulation signal pattern based upon evaluation of the monitoring such that a desired therapeutic effect results.

34. A method of treating bronchial constriction, comprising inducing at least one of an electric field and electromagnetic field in one or more lungs of a mammal such that one or more mitogenic factors, and that contribute to bronchial constriction are down-regulated.

35. The method of claim 34, wherein the mitogenic factor includes vascular endothelial growth factor (VEGF).

36. The method of claim 34, wherein the mitogenic factor effects the production of T-helper type 2 cells (TH2).

37. The method of claim 34, wherein the mitogenic factor includes one or more enzymes.

38. The method of claim 37, wherein the one or more enzymes include one or more matrix metalloproteinases (MMPs).

39. The method of claim 38, wherein the one or more MMPs include one or more of:

Stromelysin-1, gelatinase A, fibroblast collagenase (MMP-1), neutrophil collagenase (MMP-8), gelatinase B (MMP-9), stromelysin-2 (MMP-10), stromelysin-3 (MMP-11), matrilysin (MMP-7), collagenase 3 (MMP-13), and TNF-alpha converting enzyme (TACE).

40. The method of claim 34, further comprising inducing the field(s) by applying at least one electrical impulse to one or more field emitters.

41. The method of claim 40, wherein the one or more field emitters are disposed percutaneously to direct the field(s) toward the lung(s).

42. The method of claim 41, wherein the one or more field emitters are disposed at least one of on a chest of the mammal and on the back of the mammal.

43. The method of claim 40, wherein the one or more field emitters include at least one of capacitive coupling electrodes and inductive coils.

44. The method of claim 40, further comprising applying drive signals to the one or more field emitters to produce the at least one impulse and induce the field(s).

45. The method of claim 44, wherein the drive signals include at least one of sine waves, square waves, triangle waves, exponential waves, and complex impulses.

46. The method of claim 44, wherein the drive signals include a frequency of between about 10 Hz to 100 KHz.

47. The method of claim 44, wherein the drive signals include a duty cycle of between about 1 to 100%.

48. The method of claim 44, wherein the drive signals include an amplitude of between about 1 mv/cm to about 50 mv/cm.

49. The method of claim 34, further comprising applying the field(s) for a predetermined period of time.

50. The method of claim 49, wherein the predetermined period of time is between about 0.5 to about 24 hours.

51. The method of claim 34, further comprising measuring a response of the mammal to the field(s).

52. The method of claim 51, wherein the response includes one of airway pressure and lung volume.

53. The method of claim 51, further comprising adjusting at least one of an intensity and position of the field(s) as a function of the response.