Subcardiac threshold vagal nerve stimulation

• US 7,869,869 B1
• Filed: 01/11/2006
• Issued: 01/11/2011
• Est. Priority Date: 01/11/2006
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Farazi, Taraneh Ghaffari
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US11/330,884
• Time in Patent Office: 1,826 Days
• Field of Search: 607/5, 607/6, 607/9, 607/45, 607/14, 607/4
• US Class Current: 607/7
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

In one embodiment, an implantable stimulation apparatus includes a vagal nerve stimulator configured to generate electrical pulses below a cardiac threshold of a heart, and an electrode coupled to the vagal nerve stimulator which is configured to transmit the electrical pulses below the cardiac threshold, to a vagal nerve so as to inhibit injury resulting from an ischemia and/or reduce injury resulting from an ischemia. In another embodiment, an implantable stimulation apparatus includes a vagal nerve stimulator configured to generate electrical pulses below a cardiac threshold, and includes an electrode, which is coupled to the vagal nerve stimulator and configured to transmit electrical pulses to a vagal nerve so as to reduce a defibrillation threshold of the heart.

Claims

1. An implantable stimulation apparatus comprising:

a) a vagal nerve stimulator configured to generate electrical pulses below a cardiac threshold of a heart, wherein the pulses are capable of reducing a defibrillation threshold of the heart;

b) a first electrode coupled to the vagal nerve stimulator and configured to transmit electrical pulses to a vagal nerve so as to reduce a defibrillation threshold of the heart;

c) a second electrode configured so as to be capable of sensing cardiac activity of the heart; and

d) a control circuit coupled to the second electrode and the vagal nerve stimulator, wherein in response to a sensed decrease in beat rate of the heart, the control circuit adjusts the energy parameters of the electrical pulses generated by the vagal nerve stimulator by using the sensed cardiac activity of the heart to select an energy of the electric pulses that is below the cardiac threshold of the heart and effective to reduce the defibrillation threshold of the heart.

2. The implantable stimulation apparatus of claim 1, wherein the control circuit is further configured to detect a heart arrhythmia based on the cardiac activity, the implantable stimulation device further comprising:

a) a third electrode configured so as to be capable of transmitting stimulation pulses to the heart; and

b) a heart stimulator coupled to the third electrode and configured to generate the stimulation pulses for treating the heart arrhythmia.

3. The implantable stimulation apparatus of claim 2, wherein:

the heart arrhythmia is ventricular fibrillation, the heart stimulator is configured to generate stimulation pulses effective to defibrillate the heart, and the vagal nerve stimulator is operative to generate electrical pulses below the cardiac threshold of the heart effective to reduce the defibrillation threshold of the heart during defibrillation of the heart by the heart stimulator.

4. The implantable stimulation apparatus of claim 1, wherein the first electrode comprises at least one of:

(a) a flexible flap;

or (b) a helix shape.

5. The implantable stimulation apparatus of claim 4, wherein the vagal nerve stimulator is configured to supply electrical pulses comprising a current below 1 milliamp.

6. The implantable stimulation apparatus of claim 1, wherein the vagal nerve stimulator is configured to supply electrical pulses comprising:

(a) a frequency in a range of 10 Hertz to 100 Hertz;

(b) a pulse width in a range of 100 microseconds to 5 milliseconds;

(c) a voltage amplitude in a range of 0.5 volts to 20 volts; and

(d) a current below 20 milliamps.

7. The implantable stimulation apparatus of claim 1, wherein the vagal nerve stimulator is configured to supply electrical pulses comprising at least one of:

(a) continuous pulses;

(b) periodic pulses;

or (c) event triggered pulses.

8. An implantable stimulation apparatus comprising:

a) a sensor configured to sense cardiac activity of a heart;

b) a vagal nerve stimulator configured to generate subcardiac threshold electrical pulses capable of reducing a defibrillation threshold of the heart;

c) a controller coupled to the sensor and the vagal nerve stimulator, wherein in response to a sensed decrease in beat rate of the heart, the controller adjusts energy parameters of the electrical pulses generated by the vagal nerve stimulator by using the sensed cardiac activity of the heart to select an energy of the electric pulses that is below the cardiac threshold of the heart and effective to reduce the defibrillation threshold of the heart; and

d) a lead portion having a helical configuration and comprising at least one electrode coupled to the vagal nerve stimulator and configured to transmit the subcardiac threshold electrical pulses to a vagal nerve for reducing the defibrillation threshold of the heart.

9. The implantable stimulation apparatus of claim 8, wherein the controller is further configured to detect a heart arrhythmia based on the cardiac activity, the implantable stimulation device further comprising:

a) a heart stimulating electrode configured to transmit stimulation pulses to the heart; and

b) a heart stimulator coupled to the heart stimulating electrode and configured to generate the stimulation pulses for treating the heart arrhythmia.

10. The implantable stimulation apparatus of claim 8, wherein the vagal nerve stimulator is configured to supply electrical pulses comprising at least one of:

(a) continuous pulses;

(b) periodic pulses;

or (c) event triggered pulses.

11. The implantable stimulation apparatus of claim 8, wherein the lead portion comprises a securing loop configured to secure the lead portion to the vagal nerve.

12. The implantable stimulation apparatus of claim 8, wherein the lead portion further comprises three electrodes and a distal extension.

13. The implantable stimulation apparatus of claim 8, wherein the lead portion is pre-shaped to be passively fixated primarily along the dorsal wall of the superior vena cava and to descend in approximately the same angle as a branch of a right vagal nerve.

14. The implantable stimulation apparatus of claim 8, wherein the lead portion further comprises three or more electrodes and wherein at least one electrode has a polarity different than that of at least two other electrodes.

15. A method comprising:

generating electrical pulses below a cardiac threshold of a heart, wherein the electrical pulses are capable of reducing a defibrillation threshold of the heart;

sensing cardiac activity of the heart;

adjusting the energy parameters of the electrical pulses by using the sensed cardiac activity of the heart to select an energy of the electric pulses that is below the cardiac threshold of the heart; and

transmitting the electrical pulses to a vagal nerve, whereby the defibrillation threshold of the heart is reduced.

16. The method of claim 15 further comprising:

detecting a heart arrhythmia based on the cardiac activity;

generating stimulation pulses for treating the heart arrhythmia; and

transmitting the stimulation pulses to the heart.

17. The method of claim 16 further comprising generating electrical pulses below a cardiac threshold of a heart concurrently with generating stimulation pulses for treating the heart arrhythmia, wherein the heart arrhythmia is ventricular fibrillation.

18. The method of claim 15, wherein generating electrical pulses below the cardiac threshold of the heart further comprises generating the electrical pulses comprising:

(a) a frequency in a range of 10 Hertz to 100 Hertz;

(b) a pulse width in a range of 100 microseconds to 5 milliseconds;

(c) a voltage amplitude in a range of 0.5 volts to 20 volts; and

(d) a current below 20 milliamps.

19. The method of claim 18, wherein generating electrical pulses below the cardiac threshold of the heart further comprises generating the electrical pulses comprising a current below 1 milliamp.

20. The method of claim 15, wherein generating electrical pulses below the cardiac threshold of the heart further comprises generating at least one of (a) continuous electrical pulses;

(b) periodic pulses;

or (c) event triggered pulses.

21. The method of claim 15 further comprising:

positioning a lead comprising one or more electrodes along the dorsal wall of the superior vena cava to descend in approximately the same angle as a branch of a right vagal nerve;

selecting a polarity of the one or more electrodes; and

wherein the electrical pulses are low level pulse trains.