Methods and apparatus for treating anaphylaxis using electrical modulation

• US 7,711,430 B2
• Filed: 11/02/2006
• Issued: 05/04/2010
• Est. Priority Date: 02/10/2006
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: Electrocore, Llc
• Inventors: Errico, Joseph P., Mendez, Steven
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/591,768
• Publication Number:
  US 20070191902A1
• Time in Patent Office: 1,279 Days
• Field of Search: 607 2- 3, 607/42, 607/96
• US Class Current: 607/42
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle

Abstract

Methods and devices for treating anaphylaxis, anaphylactic shock, bronchial constriction, and/or asthma include providing an electrical impulse to a selected region of the vagus nerve of a patient suffering from anaphylaxis to block and/or modulate nerve signals that would regulate the function of, for example, myocardial tissue, vasodilation/constriction and/or pulmonary tissue.

Claims

1. A method of treating anaphylaxis, anaphylactic shock, bronchial constriction and/or asthma in a patient comprising applying at least one electrical impulse having a frequency between about 1 Hz and 3000 Hz to at least one selected nerve in a region of a parasympathetic nervous system of the patient, the electrical impulse being sufficient to increase a blood pressure and to relax bronchial smooth muscle and reduce a magnitude of constriction of the bronchial smooth muscle of the patient.

2. The method set forth in claim 1 wherein the region of the parasympathetic nervous system comprises a region of the vagus nerve proximal to at least one of the cardiac branch and the bronchial branch of the vagus nerve.

3. The method set forth in claim 2 wherein the region of the vagus nerve includes one or more of:

the superior and/or inferior cardiac branches of the vagus nerve;

the anterior and/or posterior bronchial branches of the vagus nerve;

the right branch of the vagus nerve,

the left branch of the vagus nerve;

at or near the anterior or posterior coronary plexus; and

at or near the anterior or posterior pulmonary plexus.

4. The method set forth in claim 1 wherein the electrical impulse does not substantially increase a heart rate of the patient.

5. The method of claim 1, wherein the electrical impulse has an amplitude of between about 1-10 volts.

6. The method of claim 5, wherein the electrical impulse has an amplitude of between about 1 volt to 2 volts.

7. The method of claim 1, wherein the electrical impulse has a pulsed-on time of between about 50 microseconds to about 800 microseconds.

8. The method of claim 1, wherein the electrical impulse has a pulsed-on time of about 200 microseconds to about 400 microseconds.

9. The method of claim 1, wherein the electrical impulse has a frequency of between about 10 to 50 Hz.

10. The method of claim 9, wherein the frequency is between about 15 to 30 Hz.

11. The method of claim 9, wherein the frequency is about 25 Hz.

12. A device for the treatment of anaphylaxis, anaphylactic shock, bronchial constriction and/or asthma in a patient 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;

one or more electrodes coupled to the impulse pulse generator; and

wherein the control unit is operable to modulate the electrical impulse generator for generation of a signal sufficient to elevate a blood pressure and relax bronchial smooth muscle and reduce a magnitude of constriction of the bronchial smooth muscle of the patient when the signal is applied via the one or more electrodes to a selected nerve in a region of the parasympathetic nervous system.

13. The device of claim 12, wherein the signal has a frequency of between about 1 to 3000 Hz.

14. The device of claim 13, wherein the frequency is between about 10 to 50 Hz.

15. The device of claim 12, wherein the signal has an amplitude of between about 1-10 volts.

16. The device of claim 12, wherein the signal has a pulsed-on time of between about 50 microseconds to about 800 microseconds.

17. The device of claim 12, wherein the signal has a pulsed-on time of about 200 microseconds to about 400 microseconds.

18. The device of claim 12 wherein the one or more electrodes are implantable within the patient.

19. A method of treating anaphylaxis, anaphylactic shock, bronchial constriction, and/or asthma in a patient, comprising applying at least one electrical impulse to one or more selected nerve(s) in one or more regions of the parasympathetic nervous system of the patient to increase a blood pressure and relax bronchial smooth muscle and reduce a magnitude of constriction of the bronchial smooth muscle of the patient.

20. The method of claim 19, further comprising:

implanting one or more electrodes to the one or more regions of the parasympathetic nervous system; and

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

21. The method of claim 20, 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 1-12 volts.

22. The method of claim 21, wherein the one or more electrical stimulation signals are of a frequency between about 750 Hz to 1250 Hz.

23. The method of claim 21, wherein the one or more electrical stimulation signals are of a frequency between about 10 Hz to 35 Hz.

24. The method of claim 21, wherein the one or more electrical stimulation signals are of an amplitude of between about 0.75 to 1.5 volts.

25. The method of claim 21, wherein the one or more electrical stimulation signals are one or more of a full or partial sinusoid, square wave, rectangular wave, triangle wave.

26. The method of claim 21, wherein the one or more electrical stimulation signals have a pulsed on-time of between about 50 to 500 microseconds.

27. The method of claim 21, 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.

28. The method of claim 21, 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.

29. The method of claim 28, wherein the pulsed on-time is one of:

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

30. The method of claim 21, further comprising maintaining a polarity of the pulse either positive or negative.

31. The method of claim 30, 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.

32. The method of claim 30, further comprising alternating the polarity of the pulse about every second.