PARASYMPATHETIC NERVE STIMULATION

• US 20120303080A1
• Filed: 06/11/2012
• Published: 11/29/2012
• Est. Priority Date: 06/13/2003
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: BioControl Medical (B.C.M) Ltd.
• Inventors: BEN-DAVID, Tamir, COHEN, Ehud, BEN-EZRA, Omry
• Application Number:
  US13/493,499
• Publication Number:
  US 20120303080A1
• Time in Patent Office: Days
• US Class Current: 607/14
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• 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 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A method is provided, including identifying that a subject is at risk of suffering from atrial fibrillation (AF). Responsively to the identifying, a risk of an occurrence of an episode of the AF is reduced by coupling an electrode device to a site of a subject containing parasympathetic nervous tissue; driving, by a control unit, the electrode device to apply an electrical current to the site not responsively to any physiological parameters sensed by any device directly or indirectly coupled to the control unit; and configuring the current to stimulate autonomic nervous tissue in the site. Other embodiments are also described.

Claims

1. A method comprising:

identifying that a subject is at risk of suffering from atrial fibrillation (AF); and

responsively to the identifying, reducing a risk of an occurrence of an episode of the AF by;

coupling an electrode device to a site of a subject containing parasympathetic nervous tissue,

driving, by a control unit, the electrode device to apply an electrical current to the site not responsively to any physiological parameters sensed by any device directly or indirectly coupled to the control unit, and

configuring the current to stimulate autonomic nervous tissue in the site.

2. The method according to claim 1, wherein the site is selected from the group consisting of:

a vagus nerve, an epicardial fat pad, a sinoatrial (SA) node fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a jugular vein, an azygos vein, an innominate vein, and a subclavian vein, and wherein applying the current comprises applying the current to the selected site.

3. The method according to claim 1, wherein the site includes the vagus nerve, and wherein applying the current comprises applying the current to the vagus nerve.

4. Apparatus comprising:

an electrode device, configured to be coupled to a site of the subject at risk of suffering from atrial fibrillation (AF), the site containing parasympathetic nervous tissue; and

a control unit, configured to reduce a risk of an occurrence of an episode of the AF by;

driving the electrode device to apply an electrical current to the site not responsively to any physiological parameters sensed by any device directly or indirectly coupled to the control unit, and

configuring the current to stimulate the nervous tissue in the site.

5. The apparatus according to claim 4, wherein the site is selected from the group consisting of:

a vagus nerve, an epicardial fat pad, a sinoatrial (SA) node fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a jugular vein, an azygos vein, an innominate vein, and a subclavian vein, and wherein the electrode device is configured to be coupled to the selected site.

6. The apparatus according to claim 4, wherein the site includes the vagus nerve, and wherein the electrode device is configured to be coupled to the vagus nerve.

7. A method for treating a subject, comprising:

applying a current to a site of the subject in respective bursts of pulses in each of a plurality of cardiac cycles of the subject, the site selected from the list consisting of;

a vagus nerve of the subject, an epicardial fat pad of the subject, a pulmonary vein of the subject, a carotid artery of the subject, a carotid sinus of the subject, a vena cava vein of the subject, and an internal jugular vein of the subject; and

configuring an electrical parameter of the current so as to minimize an effect of the applying of the current on a heart rate of the subject, by applying each of the bursts after a delay following a P-wave of the subject, the delay having a duration equal to between about two-thirds and about 90% of a duration of a cardiac cycle of the subject.

8. The method according to claim 7, wherein applying the current to the site of the subject comprises applying the current to the site of a subject who suffers from a condition selected from the list consisting of:

an autoimmune disease, an autoimmune inflammatory disease, multiple sclerosis, encephalitis, myelitis, immune-mediated neuropathy, myositis, dermatomyositis, polymyositis, inclusion body myositis, inflammatory demyelinating polyradiculoneuropathy, Guillain Barre syndrome, myasthenia gravis, inflammation of the nervous system, inflammatory bowel disease, Crohn'"'"'s disease, ulcerative colitis, SLE (systemic lupus erythematosus), rheumatoid arthritis, vasculitis, polyarteritis nodosa, Sjogren syndrome, mixed connective tissue disease, glomerulonephritis, thyroid autoimmune disease, sepsis, meningitis, a bacterial infection, a viral infection, a fungal infection, sarcoidosis, hepatitis, and portal vein hypertension.

9. The method according to claim 7, wherein applying the current comprises configuring the pulses within each of the bursts to have a pulse repetition interval of between 2 and 10 milliseconds.

10. The method according to claim 7, wherein applying the current comprises applying the bursts less than every heartbeat of the subject.

11. Apparatus for treating a subject, comprising:

an electrode device, adapted to be coupled to a site of the subject selected from the list consisting of;

a vagus nerve of the subject, an epicardial fat pad of the subject, a pulmonary vein of the subject, a carotid artery of the subject, a carotid sinus of the subject, a vena cava vein of the subject, and an internal jugular vein of the subject; and

a control unit, adapted to;

drive the electrode device to apply an electrical current to the site in respective bursts of pulses in each of a plurality of cardiac cycles of the subject, and configure an electrical parameter of the current so as to minimize an effect of the applying of the current on a heart rate of the subject, by applying each of the bursts after a variable delay following a P-wave of the subject, the delay having a duration equal to between about two-thirds and about 90% of a duration of a cardiac cycle of the subject.

12. The apparatus according to claim 11, wherein the control unit is adapted to configure the pulses within each of the bursts to have a pulse repetition interval of between 2 and 10 milliseconds.

13. The apparatus according to claim 11, wherein the control unit is adapted to apply the bursts less than every heartbeat of the subject.

14. Treatment apparatus, comprising:

an electrode device, adapted to be coupled to a site of a subject suffering from atrial fibrillation (AF), the site selected from the list consisting of;

a vagus nerve of the subject, an epicardial fat pad of the subject, a pulmonary vein of the subject, a carotid artery of the subject, a carotid sinus of the subject, a vena cava vein of the subject, and an internal jugular vein of the subject;

a pacing device, adapted to be applied to a heart of the subject; and

a control unit, adapted to;

during a first period, drive the pacing device to pace the heart, and drive the electrode device to apply an electrical current to the site, and

during a second period following the first period, withhold the electrode device from applying the electrical current to the site.

15. Apparatus according to claim 14, wherein the control unit is adapted to configure a parameter of at least one of the periods to be such as to restore normal sinus rhythm (NSR) of the subject within 2 hours after initiation of the second period.

16. Apparatus according to claim 15, wherein the site is a vagus nerve, and wherein the electrode device is adapted to be applied to the vagus nerve.

17. Apparatus according to claim 14, wherein the control unit is adapted to withhold the pacing device from pacing the heart during at least a portion of the second period.

18. Apparatus according to claim 14, wherein the control unit is adapted to configure the first period to have a duration of between about 500 milliseconds and about 30 seconds.

19. Apparatus according to claim 14, wherein the control unit is adapted to drive the electrode device to apply the electrical current substantially without changing the parameter during the first period, and with an amplitude greater than about 6 milliamps.

20. Apparatus according to claim 14, further comprising a sensor, adapted to detect an occurrence of the AF and generate a sensor signal indicative thereof, and wherein the control unit is adapted to receive the sensor signal, and to drive the pacing device and drive the electrode device to apply the electrical current responsive to the sensor signal.

21. Apparatus according to claim 14, further comprising a sensor, adapted to detect an occurrence of the AF and generate a sensor signal indicative thereof, and wherein the control unit is adapted to receive the sensor signal, and to withhold the electrode device from applying the electrical current responsive to the sensor signal.

22. Apparatus comprising an electrode assembly adapted to be coupled to nervous tissue of a subject, the electrode assembly comprising one or more conductive elements, wherein at least a portion of the electrode assembly is adapted to be dissolvable after the electrode assembly has been coupled to the tissue.

23. The apparatus according to claim 22, wherein the nervous tissue includes a nerve of the subject, and wherein the electrode assembly is adapted to be coupled to the nerve.

24. The apparatus according to claim 22, wherein the electrode assembly is adapted to come loose from the tissue upon dissolving of the dissolvable at least a portion thereof.

25. A method comprising:

providing an electrode assembly including one or more conductive elements, at least a portion of which electrode assembly is configured to be dissolvable after the electrode assembly has been coupled to nervous tissue of a subject; and

coupling the electrode assembly to the nervous tissue.

26. Apparatus for treating a subject, comprising:

an electrode device, configured to be coupled to a parasympathetic site of the subject selected from the group consisting;

of a vagus nerve of the subject, an epicardial fat pad of the subject, a pulmonary vein of the subject, a carotid artery of the subject, a carotid sinus of the subject, a coronary sinus of the subject, a vena cava vein of the subject, a jugular vein of the subject, a right ventricle of the subject, a parasympathetic ganglion of the subject, and a parasympathetic nerve of the subject; and

a control unit, configured to;

drive the electrode device to apply a current to the site,

receive a sensed physiological value of the subject selected from the group consisting of;

a temperature of the subject, a blood glucose level of the subject, a blood lipid level of the subject, a blood lactic acid level of the subject, a blood CO2 level of the subject, a blood O2 level of the subject, a blood urea level of the subject, a blood creatinine level of the subject, and a blood ammonia level of the subject, and set at least one parameter of the applied current responsively to the sensed physiological value.

27. A method for treating a subject, comprising:

applying a current to a parasympathetic site of the subject selected from the group consisting;

of a vagus nerve of the subject, an epicardial fat pad of the subject, a pulmonary vein of the subject, a carotid artery of the subject, a carotid sinus of the subject, a coronary sinus of the subject, a vena cava vein of the subject, a jugular vein of the subject, a right ventricle of the subject, a parasympathetic ganglion of the subject, and a parasympathetic nerve of the subject;

receiving a sensed physiological value of the subject selected from the group consisting of;

a temperature of the subject, a blood glucose level of the subject, a blood lipid level of the subject, a blood lactic acid level of the subject, a blood CO2 level of the subject, a blood O2 level of the subject, a blood urea level of the subject, a blood creatinine level of the subject, and a blood ammonia level of the subject; and

setting at least one parameter of the applied current responsively to the sensed physiological value.