Implantable neurostimulator for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration

• US 9,526,898 B2
• Filed: 01/07/2015
• Issued: 12/27/2016
• Est. Priority Date: 01/17/2012
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Libbus, Imad, Amurthur, Badri, KenKnight, Bruce H.
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/591,349
• Publication Number:
  US 20150119959A1
• Time in Patent Office: 720 Days
• Field of Search: 607/9
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve 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 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

A system for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration is provided. The system includes a patient-operable external controller to transmit a plurality of unique signals. The system further includes an implantable neurostimulator, which includes a recordable memory storing an autotitration operating mode that includes a maximum stimulation intensity and is configured to increase an intensity of the delivered electrical therapeutic stimulation up to a level not exceeding the maximum stimulation intensity upon receipt of one of the unique signals.

Claims

1. A vagus nerve neurostimulator for treatment of chronic cardiac dysfunction, comprising:

a pulse generator, wherein the pulse generator generates a pulsed electrical signal comprising;

a signal ON time;

a signal OFF time;

an output current;

a signal frequency;

a pulse width; and

a duty cycle defined by dividing the signal ON time by the sum of the signal ON time and signal OFF time;

a therapy lead;

an electrode communicatively coupled to the pulse generator via the therapy lead; and

a recordable memory storing a maximum stimulation intensity and an autotitration operating mode configured to cause the pulse generator to increase an intensity of the pulsed electrical signal up to a level not exceeding the maximum stimulation intensity and to receive, from a patient-operable external controller that allows the patient to provide feedback regarding whether the intensity is intolerable, a first unique signal indicating that the intensity of the delivered pulsed electrical signal is not tolerable to the patient.

2. The vagus nerve neurostimulator according to claim 1, wherein the signal frequency comprises approximately 10 Hz.

3. The vagus nerve neurostimulator according to claim 1, wherein the autotitration mode is configured to cause the pulse generator to apply the pulsed electrical signal to a vagus nerve via the electrode to propagate action potentials in both afferent and efferent directions along the vagus nerve at an intensity that avoids acute physiological side effects.

4. The vagus nerve neurostimulator according to claim 1, wherein the autotitration mode is configured to cause the pulse generator to increase the intensity of the delivered pulsed electrical signal in association with receipt of a second unique signal.

5. The vagus nerve neurostimulator according to claim 1, wherein the autotitration mode is further configured to cause the pulse generator to discontinue the increase in intensity upon receipt of the first unique signal.

6. The vagus nerve neurostimulator according to claim 1, wherein the duty cycle comprises a value in a range of 5% to 20%.

7. The vagus nerve neurostimulator according to claim 1, wherein the pulse generator is configured to deliver the pulsed electrical signal to a vagus nerve via the electrode to induce heart rate variability during the signal ON time.

8. The vagus nerve neurostimulator according to claim 1, further comprising a sensor configured to monitor heart rate.

9. The vagus nerve neurostimulator according to claim 1, wherein:

the patient-operable external controller is configured to transmit a plurality of signals to the pulse generator including a second unique signal associated with an up-titration command;

wherein the autotitration operating mode is further configured to cause the pulse generator to continue delivery of the pulsed electrical signal at the intensity up to the level not exceeding the maximum stimulation intensity regardless of receipt of the second unique signal associated with the up-titration command from the patient-operable external controller upon the intensity of the delivered electrical therapeutic stimulation equaling the maximum stimulation intensity.

10. The vagus nerve neurostimulator according to claim 1, wherein the autotitration operating mode is configured to cause the pulse generator to increase the intensity of the pulsed electrical signal upon receipt of a unique tolerance signal indicating that the current intensity of the pulsed electrical signal is tolerable to the patient, and decrease the intensity upon receipt of the first unique signal indicating that the current intensity of the pulsed electrical signal is not tolerable to the patient.

11. A method of operating a vagus nerve neurostimulator to treat chronic cardiac dysfunction, comprising:

delivering a pulsed electrical signal to a vagus nerve via an electrode coupled to a pulse generator via a therapy lead, the pulsed electrical signal comprising;

a signal ON time;

a signal OFF time;

an output current;

a signal frequency;

a pulse width; and

a duty cycle defined by dividing the signal ON time by the sum of the signal ON time and signal OFF time;

operating the pulse generator in an autotitration operating mode, the autotitration operating mode comprising increasing an intensity of the pulsed electrical signal up to a level not exceeding a maximum stimulation intensity stored in a recordable memory; and

receiving, from a patient-operable external controller that allows the patient to provide feedback regarding whether the intensity is intolerable, a first unique signal indicating that the intensity of the delivered pulsed electrical signal is not tolerable to the patient.

12. The method according to claim 11, wherein the signal frequency comprises approximately 10 Hz.

13. The method according to claim 11, wherein the delivering the pulsed electrical signal to the vagus nerve comprises delivering the pulsed electrical signal to the vagus nerve to propagate action potentials in both afferent and efferent directions along the vagus nerve at an intensity that avoids acute physiological side effects.

14. The method according to claim 11, wherein the operating the pulse generator in the autotitration operating mode comprises increasing the intensity of the delivered pulsed electrical signal in association with receipt of a second unique signal.

15. The method according to claim 11, wherein the autotitration mode is configured to discontinue the increase in intensity upon receipt of the first unique signal.

16. The method according to claim 11, wherein the duty cycle comprises a value in a range of 5% to 20%.

17. The method according to claim 11, wherein the delivering the pulsed electrical signal to the vagus nerve induces heart rate variability during the signal ON time.

18. The method according to claim 11, further comprising monitoring a patient heart rate.

19. The method according to claim 11, further comprising:

in response to receiving from the patient-operable external controller a unique tolerance signal indicating that the current intensity of the pulsed electrical signal is tolerable to the patient, increasing the intensity of the pulsed electrical signal; and

in response to receiving from the patient-operable external controller the first unique signal indicating that the current intensity of the pulsed electrical signal is not tolerable to the patient, decreasing the intensity of the pulsed electrical signal.

20. The method according to claim 11, further comprising:

continuing delivery of the pulsed electrical signal at the intensity up to the level not exceeding the maximum stimulation intensity regardless of receipt of a second unique signal associated with an up-titration command from a patient-operable external controller upon the intensity of the delivered electrical therapeutic stimulation equaling the maximum stimulation intensity.