Electrical stimulation treatment of hypotension

• US 8,041,428 B2
• Filed: 11/04/2009
• Issued: 10/18/2011
• Est. Priority Date: 02/10/2006
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: Electrocore, Llc
• Inventors: Errico, Joseph P., Mendez, Steven, Simon, Bruce
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): WIELAND, ROBERT N
• Application Number:
  US12/612,177
• Publication Number:
  US 20100114261A1
• Time in Patent Office: 713 Days
• Field of Search: 607/42, 607/44, 607/45
• 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 hypotension in a patient comprising applying at least one electrical impulse to at least one nerve in a selected region of a parasympathetic nervous system of the patient, the electrical impulse being sufficient to modulate one or more afferent nerves in a selected region of the parasympathetic nervous system such that a ratio of blood pressure to heart rate is increased in the patient.

2. The method set forth in claim 1 wherein the electrical impulse is sufficient to stimulate the afferent nerves in the selected region of the parasympathetic nervous system.

3. The method set forth in claim 1 wherein the electrical impulse is insufficient to substantially modulate the efferent nerves in the selected region of the parasympathetic nervous system.

4. The method set forth in claim 2 wherein the electrical impulse is sufficient to cause the afferent nerves in the selected region to modulate one or more nerves in a sympathetic nervous system of the patient responsible for modulating blood pressure.

5. The method set forth in claim 4 wherein the afferent nerves in the selected region cause an increase in activity of the one or more nerves of the sympathetic nervous system.

6. The method set forth in claim 1 further comprising the step of positioning an electrode adjacent to or near the selected region of the parasympathetic nervous system and applying an electrical signal having an amplitude to the electrode;

wherein a distance between the electrode and the selected region and the amplitude are selected such that the electrical signal modulates the afferent nerves at the selected region of the parasympathetic nervous system without substantially modulating the efferent nerves at the selected region of the parasympathetic nervous system.

7. The method of claim 6 wherein the amplitude is less than 12 volts.

8. The method of claim 1 wherein the electrical impulse is sufficient to increase blood pressure and maintain a substantially stable heart rate.

9. The method of claim 1 wherein the electrical impulse is sufficient to maintain the blood pressure at a lower heart rate.

10. The method of claim 1 wherein the electrical impulse has a frequency of about 10 Hz to 100 Hz.

11. The method of claim 1 wherein the electrical impulse has a frequency of about 15-30 Hz, a pulsed on-time of about 100-400 microseconds, and an amplitude of about 0.1 to 2 volts.

12. A method of treating a patient suffering from systemic hypotension comprising applying at least one electrical impulse to at least one nerve in a selected region of a parasympathetic nervous system of the patient, the electrical impulse being sufficient to modulate one or more afferent nerves of the parasympathetic nervous system to increase a ratio of blood pressure to heart rate in the patient.

13. The method of claim 12 wherein the electrical impulse is sufficient to substantially maintain a blood pressure of the patient while maintaining a substantially stable heart rate.

14. The method of claim 12 wherein the electrical impulse is sufficient to substantially maintain blood pressure at a lower heart rate.

15. A method for treating a patient suffering from systemic hypotension comprising:

positioning an electrode adjacent to or near a cricoid cartilage of the patient; and

applying an electrical impulse to the electrode, the electrical impulse being sufficient to inhibit a drop in blood pressure associated with the systemic hypotension of the patient.

16. The method of claim 15 wherein the electrode is positioned within about 1-10 mm of the cricoid cartilage.

17. The method of claim 15 wherein the electrode is positioned within the cricoid cartilage.

18. The method of claim 15 wherein the electrical impulse is applied to at least one nerve in a selected region of a parasympathetic nervous system of the patient, the electrical impulse being sufficient to modulate one or more afferent nerves of the parasympathetic nervous system such that increased blood pressure is achieved.

19. The method of claim 18 wherein the electrical impulse is sufficient to stimulate the afferent nerves of the parasympathetic nervous system.

20. The method of claim 18 wherein the electrical impulse is insufficient to substantially modulate the efferent nerves of the parasympathetic nervous system.

21. The method claim 19 wherein the electrical impulse is sufficient to cause the afferent nerves to cause an increase in activity of one or more nerves in a sympathetic nervous system of the patient responsible for modulating blood pressure.

22. A method for treating a patient suffering from hypovolemia or hypovolemic shock comprising applying an electrical impulse to target region in or around the neck of the patient sufficient to extend the life of the patient, wherein the electrical impulse is sufficient to increase a ratio of blood pressure to rate in the patient.

23. The method of claim 22 further comprising positioning an electrode at the target region in or on the neck of the patient and applying the electrical impulse to the electrode.

24. The method of claim 23 wherein the positioning step comprises introducing the electrode through an esophagus of the patient to the target site within the neck.

25. The method of claim 23 wherein the positioning step comprises introducing the electrode through a trachea of the patient to the target site within the neck.

26. The method of claim 23 wherein the target region is adjacent to or within the cricoid cartilage.

27. The method of claim 24 further comprising introducing an expandable electrode through the esophagus of the patient to the target site and expanding the electrode to contact tissue at the target site.

28. The method of claim 27 wherein the expanding step is carried out by inflating the electrode with a fluid.

29. The method of claim 23 further comprising introducing an inflatable enclosure housing an electrode through the esophagus of the patient to the target site and expanding the enclosure to contact tissue at the target site.

30. The method of claim 29 wherein the expanding step is carried out by inflating the enclosure with an electrically conductive fluid that electrically couples the electrode with at least a portion of the outer wall of the enclosure.

31. A method for treating a patient suffering from sepsis or septic shock comprising applying an electrical impulse to a target region in or around the neck of the patient sufficient to extend the life of the patient, wherein the electrical impulse is sufficient to increase a ratio of blood pressure to heart rate in the patient.

32. The method of claim 31 further comprising positioning an electrode at the target region in or on the neck of the patient and applying the electrical impulse to the electrode.

33. The method of claim 32 wherein the positioning step comprises introducing the electrode through an esophagus of the patient to the target site within the neck.

34. The method of claim 32 wherein the positioning step comprises introducing the electrode through a trachea of the patient to the target site within the neck.

35. The method of claim 32 wherein the target region is adjacent to or within the cricoid cartilage of the patient.

36. The method of claim 33 further comprising introducing an expandable electrode through the esophagus of the patient to the target site and expanding the electrode to contact tissue at the target site.

37. The method of claim 36 wherein the expanding step is carried out by inflating the electrode with a fluid.

38. The method of claim 33 further comprising introducing an inflatable enclosure housing an electrode through the esophagus of the patient to the target site and expanding the enclosure to contact tissue at the target site.

39. The method of claim 38 wherein the expanding step is carried out by inflating the enclosure with an electrically conductive fluid that electrically couples the electrode with at least a portion of the outer wall of the enclosure.