Vagal stimulation for anti-embolic therapy

• US 7,885,711 B2
• Filed: 06/10/2004
• Issued: 02/08/2011
• Est. Priority Date: 06/13/2003
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: BioControl Medical (B.C.M) Ltd.
• Inventors: Ben-David, Tamir, Cohen, Ehud, Ben-Ezra, Omry
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): Dietrich; Joseph M
• Application Number:
  US10/560,654
• Publication Number:
  US 20060271115A1
• Time in Patent Office: 2,434 Days
• Field of Search: 607/4, 607/5, 607/9, 607/14
• US Class Current: 607/5
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• 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 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/39624 Pain reduction therapy

Abstract

Apparatus (20) for treating a subject (30) suffering from spontaneous atrial fibrillation includes an electrode device (22), adapted to be coupled to a site of the subject (30) selected from the list consisting of: a vagus nerve (24) of the subject (30), an epicardial fat pad of the subject (30), a pulmonary vein of the subject (30), a carotid artery of the subject (30), a carotid sinus of the subject (30), a vena cava vein of the subject (30), and an internal jugular vein of the subject (30), and a control unit (32), adapted to drive the electrode device (22) to apply an electrical current to the site, and to configure the current to maintain the spontaneous AF for at least about 24 hours, so as to modify blood flow within the atria and reduce risk of thromboembolic events.

Claims

1. A treatment method, comprising:

applying an electrical current to a vagus nerve of a subject; and

modulating the current to cause fluctuation in atrial contractility sufficiently to reduce a risk of an occurrence of a thromboembolic event,

wherein modulating the current to cause the fluctuation in the atrial contractility comprises cycling between first and second stimulation periods, and;

during the first stimulation periods, configuring the current to cause a reduction in a force of contraction of atrial cells of the subject, and configuring the current so as to induce action potentials in the vagus nerve; and

during the second stimulation periods, configuring the current to cause an increase in the reduced force of contraction of the atrial cells, and configuring the current so as to block action potentials in the vagus nerve.

2. A method according to claim 1, wherein applying the current comprises identifying that the subject is suffering from atrial fibrillation (AF) and from increased risk of thromboembolic events, and applying the current responsively to the identifying.

3. A method according to claim 1, wherein applying the current comprises detecting an occurrence of atrial fibrillation (AF), and applying the current responsively to the detecting.

4. A method according to claim 1, wherein modulating the current comprises sensing at least one physiological variable of the subject, and synchronizing a commencement of at least one of the first and second stimulation periods with the sensed physiological variable.

5. A method according to claim 1, wherein applying the current comprises identifying that the subject is suffering from atrial fibrillation (AF), and applying the current responsively to the identifying.

6. A treatment method, comprising:

applying an electrical current to a vagus nerve of a subject; and

modulating the current to cause fluctuation in atrial contractility sufficiently to reduce a risk of an occurrence of a thromboembolic event,

wherein modulating the current to cause the fluctuation in the atrial contractility comprises cycling between first and second stimulation periods, and;

during the first stimulation periods, configuring the current to cause a reduction in a force of contraction of atrial cells of the subject; and

during the second stimulation periods, configuring the current to cause an increase in the reduced force of contraction of the atrial cells,

wherein modulating the current comprises sensing at least one physiological variable of the subject, and synchronizing a commencement of at least one of the first and second stimulation periods with the sensed physiological variable,

wherein the sensed physiological variable includes a QRS-complex of the subject, and wherein modulating the current comprises initiating each of the first stimulations period within about 50 milliseconds after an occurrence of the QRS-complex.

7. A method according to claim 6, wherein applying the current comprises identifying that the subject is suffering from atrial fibrillation (AF) and from increased risk of thromboembolic events, and applying the current responsively to the identifying.

8. A method according to claim 6, wherein applying the current comprises detecting an occurrence of atrial fibrillation (AF), and applying the current responsively to the detecting.

9. A method according to claim 6, wherein applying the current comprises identifying that the subject is suffering from atrial fibrillation (AF), and applying the current responsively to the identifying.

10. A treatment method, comprising:

applying an electrical current to a vagus nerve of a subject; and

modulating the current to cause fluctuation in atrial contractility sufficiently to reduce a risk of an occurrence of a thromboembolic event,

wherein modulating the current to cause the fluctuation in the atrial contractility comprises cycling between first and second stimulation periods, and;

during the first stimulation periods, configuring the current to cause a reduction in a force of contraction of atrial cells of the subject; and

during the second stimulation periods, configuring the current to cause an increase in the reduced force of contraction of the atrial cells,

wherein modulating the current comprises sensing at least one physiological variable of the subject, and synchronizing a commencement of at least one of the first and second stimulation periods with the sensed physiological variable,

wherein the sensed physiological variable includes an expiration by the subject, and wherein modulating configuring the current comprises initiating each of the first stimulation periods within about 500 milliseconds after a beginning of the expiration.

11. A method according to claim 10, wherein applying the current comprises identifying that the subject is suffering from atrial fibrillation (AF) and from increased risk of thromboembolic events, and applying the current responsively to the identifying.

12. A method according to claim 10, wherein applying the current comprises detecting an occurrence of atrial fibrillation (AF), and applying the current responsively to the detecting.

13. A method according to claim 10, wherein applying the current comprises identifying that the subject is suffering from atrial fibrillation (AF), and applying the current responsively to the identifying.

14. A treatment method, comprising:

applying an electrical current to a vagus nerve of a subject; and

modulating the current to cause fluctuation in atrial contractility sufficiently to reduce a risk of an occurrence of a thromboembolic event,

wherein modulating the current to cause the fluctuation in the atrial contractility comprises cycling between first and second stimulation periods, and;

during the first stimulation periods, configuring the current to cause a reduction in a force of contraction of atrial cells of the subject; and

during the second stimulation periods, configuring the current to cause an increase in the reduced force of contraction of the atrial cells,

wherein modulating the current comprises sensing at least one physiological variable of the subject, and synchronizing a commencement of at least one of the first and second stimulation periods with the sensed physiological variable,

wherein the sensed physiological variable includes diastole of the subject, and wherein modulating configuring the current comprises initiating each of the second stimulation periods substantially simultaneously with a portion of the diastole.

15. A method according to claim 14, wherein modulating the current comprises setting each of the first stimulation periods to have a duration of between about 100 milliseconds and about 1000 milliseconds.

16. A method according to claim 14, wherein modulating the current comprises setting each of the second stimulation periods to have a duration of between about 200 milliseconds and about 15 seconds.

17. A method according to claim 14, wherein modulating the current comprises configuring the current to have a first frequency during the first stimulation periods, and a second frequency during the second stimulation periods, the first frequency greater than the second frequency.

18. A method according to claim 14, wherein modulating the current comprises configuring the current to have a first amplitude during the first stimulation periods, and a second amplitude during the second stimulation periods, the first amplitude greater than the second amplitude.

19. A method according to claim 14, wherein applying the current comprises:

applying the current during the first stimulation periods; and

withholding applying the current during the second stimulation periods.

20. A method according to claim 14,

wherein applying the current comprises applying the current in respective bursts in each of a plurality of cardiac cycles of the subject, and

wherein modulating the current comprises configuring each pulse of each of the bursts to have a pulse width of at least a first pulse width during the first stimulation periods, and to have a pulse width of less than a second pulse width during the second stimulation periods, the first pulse width being greater than or equal to the second pulse width.

21. A method according to claim 14,

wherein applying the current comprises applying the current in respective bursts in each of a plurality of cardiac cycles of the subject, and

wherein modulating the current comprises configuring each of the bursts to have a number of pulses of at least a first number of pulses during the first stimulation periods, and to have a number of pulses of less than a second number of pulses during the second stimulation periods, the first number of pulses being greater than or equal to the second number of pulses.

22. A method according to claim 14, wherein applying the current comprises identifying that the subject is suffering from atrial fibrillation (AF) and from increased risk of thromboembolic events, and applying the current responsively to the identifying.

23. A method according to claim 14, wherein applying the current comprises detecting an occurrence of atrial fibrillation (AF), and applying the current responsively to the detecting.

24. A method according to claim 14, wherein applying the current comprises identifying that the subject is suffering from atrial fibrillation (AF), and applying the current responsively to the identifying.