Electrical stimulation treatment of hypotension

• US 8,612,004 B2
• Filed: 06/29/2012
• Issued: 12/17/2013
• Est. Priority Date: 02/10/2006
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Errico, Joseph P., Simon, Bruce J., Mendez, Steven
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/537,547
• Publication Number:
  US 20120265280A1
• Time in Patent Office: 536 Days
• Field of Search: 607/44, 607/9, 607/2, 607/14, 607/40, 604/506, 514/1
• US Class Current: 607/44
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• 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 1/36053 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 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle

Abstract

The present invention includes methods and devices for treating hypotension, such as in cases of shock, including septic shock, anaphylactic shock and hypovolemia. The method includes the step of applying at least one electrical impulse to at least one selected region of a parasympathetic nervous system of the patient. The electrical impulse is sufficient to modulate one or more nerves of the parasympathetic nervous system to increase the ratio of blood pressure to heart rate and relieve the condition and/or extend the patient'"'"'s life.

Claims

1. A method of treating a patient with a disorder comprising;

providing an electrical impulse generator and one or more electrodes coupled to the electrical impulse generator;

placing the one or more electrodes in or on a neck of the patient at a location spaced away from a target nerve region by a distance of about 5 to 20 mm;

activating the impulse generator to deliver an electrical impulse to the target nerve region, the electrical impulse having a frequency of from about 10 Hz to 35 Hz.

2. The method of claim 1, wherein the step of placing the one or more electrodes comprises placing the electrode(s) adjacent one or more nerve(s) of the parasympathetic nervous system.

3. The method of claim 2 wherein the step of activating the impulse generator further comprises activating the impulse generator to treat hypertension.

4. The method of claim 1, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has an amplitude of between about 1-20 volts.

5. The method of claim 1, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has an amplitude of between about 2-12 volts.

6. The method of claim 1, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has an amplitude of less than about 12 volts.

7. The method of claim 1, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has a pulsed on-time of between about 50 to 500 microseconds.

8. The method of claim 1, wherein the step of placing the one or more electrodes comprises placing the electrode(s) adjacent one or more nerve(s) of the parasympathetic nervous system located in the neck of a patient.

9. The method of claim 1, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which impulse has an amplitude of between about 1 volt and about 12 volts.

10. The method of claim 1, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has a frequency of about 25 Hz, a pulsed on-time of about 200 microseconds, and an amplitude of about 1 volt.

11. The method of claim 1, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which the control unit maintains at a either a positive or negative polarity.

12. The method of claim 1, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which control unit alternates between a positive polarity for some periods of the wave and negative polarity for some other periods of the wave.

13. The method of claim 12, wherein the step of activating the impulse generator further comprises activating the impulse generator to alternate the polarity of the pulse about every second.

14. The method of claim 1 wherein the step of placing the one or more electrodes comprises implanting the electrode(s).

15. The method of claim 1, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which is one or more of a full or partial sinusoid, square wave, rectangular wave, triangle wave.

16. A method of treating a patient with a disorder comprising;

providing an electrical impulse generator and one or more electrodes coupled to the electrical impulse generator;

placing the one or more electrodes in a natural orifice of the patient at a location spaced away from a target nerve region by a distance of about 5 to 20 mm; and

activating the impulse generator to deliver an electrical impulse to the target nerve region, the electrical impulse having a frequency of from about 10 Hz to 35 Hz.

17. The method of claim 16, wherein the step of placing the one or more electrodes comprises placing the electrode(s) adjacent one or more nerve(s) of the parasympathetic nervous system.

18. The method of claim 17 wherein the step of activating the impulse generator further comprises activating the impulse generator to treat hypertension.

19. The method of claim 16, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has an amplitude of between about 1-20 volts.

20. The method of claim 16, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has an amplitude of between about 2-12 volts.

21. The method of claim 16, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has an amplitude of less than about 12 volts.

22. The method of claim 16, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has a pulsed on-time of between about 50 to 500 microseconds.

23. The method of claim 16, wherein the step of placing the one or more electrodes comprises placing the electrode(s) adjacent one or more nerve(s) of the parasympathetic nervous system located in the neck of a patient.

24. The method of claim 16, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which impulse has an amplitude of between about 1 volt and about 12 volts.

25. The method of claim 16, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which has a frequency of about 25 Hz, a pulsed on-time of about 200 microseconds, and an amplitude of about 1 volt.

26. The method of claim 16, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which the control unit maintains at a either a positive or negative polarity.

27. The method of claim 16, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which control unit alternates between a positive polarity for some periods of the wave and negative polarity for some other periods of the wave.

28. The method of claim 27, wherein the step of activating the impulse generator further comprises activating the impulse generator to alternate the polarity of the pulse about every second.

29. The method of claim 16, wherein the step of placing one or more electrodes in a natural orifice comprises placing the electrode(s) in the esophagus of the patient.

30. The method of claim 16, wherein the step of placing the one or more electrodes in a natural orifice comprises positioning the electrode(s) on or in a balloon that is placed in the esophagus of the patient.

31. The method of claim 16, wherein the step of placing the one or more electrodes in a natural orifice comprises placing a nasogastric tube carrying the electrode(s) into the esophagus of the patient.

32. The method of claim 16, wherein the step of placing the one or more electrodes in a natural orifice comprises placing the electrode(s) in the trachea of the patient.

33. The method of claim 31, wherein the step of placing the one or more electrodes comprises positioning the electrode(s) on or in a balloon that is placed in the trachea of the patient.

34. The method of claim 16, wherein the step of placing the one or more electrodes in a natural orifice comprises placing a nasogastric tube carrying the electrode(s) into the trachea of the patient.

35. The method of claim 16 wherein the step of placing the one or more electrodes comprises implanting the electrode(s).

36. The method of claim 16, wherein the step of activating the impulse generator further comprises activating the impulse generator to deliver an electrical impulse to target nerve region which is one or more of a full or partial sinusoid, square wave, rectangular wave, triangle wave.