Electrical stimulation treatment of hypotension

• US 7,725,188 B2
• Filed: 11/02/2006
• Issued: 05/25/2010
• Est. Priority Date: 02/10/2006
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: Electrocore, Llc
• Inventors: Errico, Joseph P., Mendez, Steven, Pastena, James R.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/592,095
• Publication Number:
  US 20070191905A1
• Time in Patent Office: 1,300 Days
• Field of Search: 607 2- 3, 607/23, 607/18, 607/44, 607/46, 607/120, 607/4, 600/500
• US Class Current: 607/23
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Methods and devices for treating hypotension, such as in cases of shock, including septic shock and anaphylactic shock, wherein the treatment includes providing an electrical impulse to a selected region of the vagus nerve of a patient suffering from hypotension to block and/or modulate nerve signals that regulate blood pressure.

Claims

1. A method of treating hypotension comprising applying at least one electrical impulse to at least one nerve in a selected region of a parasympathetic nervous system of a mammal in need of relief from hypotension, the electrical impulse being sufficient to stimulate the nerve in the selected region of the parasympathetic nervous system and increase blood pressure in the mammal.

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

3. The method set forth in claim 2 wherein increased blood pressure is achieved by at least one of:

improving myocardium performance;

increasing heart function; and

controlling vasoconstriction.

4. The method set forth in claim 1 wherein the electrical impulse is sufficient to increase blood pressure and maintain a stable heart rate.

5. The method of claim 1, wherein the electrical impulse is of a frequency between about 1 Hz to 3000 Hz, and an amplitude of between about 1-12 volts.

6. The method of claim 1 wherein the electrical impulse is of a frequency between about 10 Hz to 35 Hz.

7. The method of claim 1 wherein the electrical impulse has a pulsed on-time of between about 50 to 500 microseconds.

8. A device for the treatment of hypotension 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;

at least one electrode coupled to the electrical impulse generator; and

at least one electrode lead coupled to the electrode for attachment to one or more nerve(s) in one or more selected regions of a parasympathetic nervous system of a mammal;

wherein the control unit modulates the electrical impulse generator for generation of a signal suitable for stimulating the parasympathetic nervous system and increasing blood pressure in the mammal when the signal is applied via the electrode lead to the one or more selected regions of the parasympathetic nervous system.

9. The device of claim 8, wherein the electrical impulse is of a frequency between about 1 Hz to 3000 Hz, and an amplitude of between about 1-12 volts.

10. The device of claim 8 wherein the electrical impulse is of a frequency between about 10 Hz to 35 Hz.

11. The device of claim 8 wherein the electrical impulse has a pulsed on-time of between about 50 to 500 microseconds.

12. The device of claim 8 wherein the electrode is configured for implantation at a target region adjacent to or near the one or more nerve(s) within the parasympathetic nervous system.

13. A method of treating hypotension associated with shock comprising applying at least one electrical impulse to one or more nerve(s) in one or more selected regions of a parasympathetic nervous system of a patient, the electrical impulse being sufficient to stimulate the parasympathetic nervous system such that blood pressure is increased in the patient.

14. The method of claim 13, further comprising:

implanting one or more electrodes to the selected 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.

15. The method of claim 13, wherein the electrical impulse has a frequency between about 1 Hz to 3000 Hz, and an amplitude of between about 1-12 volts.

16. The method of claim 15, wherein the electrical impulse has a frequency between about 750 Hz to 1250 Hz.

17. The method of claim 15, wherein the electrical impulse has a frequency between about 10 Hz to 35 Hz.

18. The method of claim 15, wherein the electrical impulse has an amplitude of between about 0.75 to 1.5 volts.

19. The method of claim 15, wherein the electrical impulse is one or more of a full or partial sinusoid, square wave, rectangular wave, triangle wave.

20. The method of claim 15, wherein the electrical impulse has a pulsed on-time of between about 50 to 500 microseconds.

21. The method of claim 15, wherein the electrical impulse has a frequency of about 25 Hz, a pulsed on-time of about 200-400 microseconds, and an amplitude of about 1 volt.

22. The method of claim 15, wherein the electrical impulse has a frequency of about 25 Hz, a pulsed on-time of between about 100 to 400 microseconds, and an amplitude of about 1 volt.

23. The method of claim 22, wherein the pulsed on-time is one of:

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

24. The method of claim 15, further comprising maintaining a polarity of the pulse either positive or negative.

25. The method of claim 24, 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.

26. The method of claim 24, further comprising alternating the polarity of the pulse about every second.