Nerve stimulation for treatment of syncope

• US 20070027497A1
• Filed: 07/27/2005
• Published: 02/01/2007
• Est. Priority Date: 07/27/2005
• Status: Abandoned Application

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Parnis, Steven
• Application Number:
  US11/190,398
• Publication Number:
  US 20070027497A1
• Time in Patent Office: Days
• US Class Current: 607/45
• 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

Abstract

A method and apparatus for treating a syncope disorder is disclosed. The method comprises coupling a first electrode to a sympathetic nerve of the patient, and then applying a first therapeutic electrical signal to the electrode to stimulate the sympathetic nerve, wherein the stimulation causes an increase in the blood pressure of the patient to a level that is above a predetermined threshold level, whereby dizziness or fainting by the patient is deterred or prevented.

Claims

1. A method of treating syncope comprising:

coupling a first electrode to a sympathetic nerve of a patient suffering from a syncope disorder; and

applying a first therapeutic electrical signal to said electrode to stimulate said sympathetic nerve, wherein said stimulation causes an increase in the blood pressure of the patient to a level that is above a predetermined threshold level, whereby dizziness or fainting by the patient is deterred or prevented.

2. The method of claim 1 further comprising:

coupling a second electrode to a vagus nerve of the patient; and

applying a second therapeutic electrical signal to said second electrode to stimulate said vagus nerve, wherein said stimulation of said vagus nerve produces a physiological result selected from the group consisting of decreasing the blood pressure of the patient to a level that is above said predetermined threshold level, and counteracting an increase in blood pressure caused by said stimulation of said sympathetic nerve.

3. The method of claim 2 wherein counteracting said increase in blood pressure comprises maintaining the blood pressure of said patient between a predetermined lower threshold and a predetermined upper threshold by applying said first and second therapeutic electrical signals to said nerves sequentially, whereby dizziness or fainting by the patient is deterred or prevented.

4. The method of claim 2 wherein counteracting said increase in blood pressure comprises maintaining the blood pressure of said patient between a predetermined lower threshold and a predetermined upper threshold by applying said first and second therapeutic electrical signals to said nerves simultaneously, whereby dizziness or fainting by the patient is deterred or prevented.

5. The method of claim 1 wherein said sympathetic nerve comprises a target location in the cervical plexus.

6. The method of claim 1 wherein said sympathetic nerve comprises at least a portion of a nerve on the esophagus.

7. The method of claim 1 comprising:

providing an electrical signal generator capable of generating a pulsed electrical signal;

providing at least one electrode;

implanting the electrical signal generator in the patient'"'"'s body;

surgically coupling said first electrode to said sympathetic nerve of the patient;

coupling the electrical signal generator to said first electrode;

generating a predetermined pulsed electrical signal by said electrical signal generator; and

applying said pulsed electrical signal to said first electrode to stimulate said sympathetic nerve, wherein said stimulation causes an increase in the blood pressure of the patient to a level that is above a predetermined threshold level, whereby dizziness or fainting by the patient is deterred or prevented.

8. The method of claim 7 comprising:

providing a sensor to detect postural changes of said patient;

coupling said sensor to said electrical signal generator;

detecting a change in the patient'"'"'s posture; and

applying said pulsed electrical signal to said sympathetic nerve in response to said detected change in posture, whereby deterrence or prevention of dizziness or fainting is enhanced.

9. The method of claim 8 wherein said sensor is an accelerometer.

10. The method of claim 8 wherein applying said pulsed electrical signal to said sympathetic nerve comprises increasing the magnitude of an existing pulsed electrical signal applied to said sympathetic nerve.

11. The method of claim 7 comprising:

providing a sensor for detecting a change in a predetermined physiological parameter in the patient;

coupling said sensor to said electrical signal generator;

detecting a change in said predetermined physiological parameter; and

applying said pulsed electrical signal to said sympathetic nerve in response to said detected change in said physiological parameter, whereby deterrence or prevention of dizziness or fainting is enhanced.

12. The method of claim 11 wherein said physiological parameter comprises a catecholamine level measured in the patient'"'"'s blood.

13. The method of claim 7 comprising:

providing a sensor for detecting a manual activation command from the patient;

coupling said manual activation sensor to said electrical signal generator;

detecting a manual activation command by the patient experiencing a precursor symptom of syncope; and

applying said pulsed electrical signal to said sympathetic nerve in response to said detected manual activation command, whereby deterrence or prevention of dizziness or fainting is enhanced.

14. The method of claim 7 comprising:

programming said electrical signal generator to define said pulsed electrical signal by a plurality of predetermined electrical parameters including a current magnitude, a pulse frequency, and a pulse width, wherein said defined electrical parameters are effective for deterring or preventing dizziness or fainting by the patient when said electrical signal is applied to said sympathetic nerve.

15. The method of claim 1, wherein said first therapeutic electrical signal comprises an acute electrical stimulation signal and a chronic electrical stimulation signal, said method further comprising:

applying said acute electrical stimulation signal to said sympathetic nerve to alleviate an acute syncope episode; and

applying said chronic stimulation signal to said sympathetic nerve to deter or prevent a recurrence of syncope.

16. The method of claim 1, wherein said first therapeutic electrical signal is defined by an on-time during which said signal is applied to said sympathetic nerve and an off-time during which no signal is applied to said nerve, said signal being effective to counteract an undesirable blood pressure increase resulting from parasympathetic stimulation.

17. The method of claim 16, wherein said on-time comprises about 30 seconds on and said off-time comprises about five minutes.

18. The method of claim 1 further comprising administering a pharmaceutical agent to said patient to lower blood pressure.

19. A method of treating syncope comprising:

providing an electrical signal generator capable of generating a pulsed electrical signal;

providing at least one electrode;

implanting the electrical signal generator in the body of a patient suffering from a syncope disorder;

surgically coupling said first electrode to a sympathetic nerve of the patient;

coupling the electrical signal generator to said electrode;

generating a predetermined pulsed electrical signal by said electrical signal generator; and

applying said pulsed electrical signal to said first electrode to stimulate said sympathetic nerve, whereby said stimulation causes an increase in blood pressure of the patient to a level that is above a predetermined threshold level, whereby the syncope disorder is ameliorated.

20. A method of treating syncope comprising:

stimulating the sympathetic nervous system of an individual suffering from a syncope disorder such that the individual'"'"'s blood catecholamine level is increased, causing augmentation of vasomotor tone of the individual'"'"'s vascular system and thereby deterring fainting.

21. The method of claim 20 comprising:

detecting a change in a physiological parameter that is indicative of syncope or pre-syncope; and

applying a therapeutic electrical signal to a sympathetic nerve of the patient effective to cause an increase in blood catecholamine level in the patient, whereby vasomotor tone in said patient is augmented and fainting is deterred or prevented.

22. The method of claim 21 wherein said stimulating comprises electrically stimulating a cervical plexus.