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

• US 8,700,150 B2
• Filed: 06/30/2013
• Issued: 04/15/2014
• 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): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/931,961
• Publication Number:
  US 20130289646A1
• Time in Patent Office: 289 Days
• Field of Search: 607/118, 607/9, 607/3, 607/7, 607/2
• US Class Current: 607/9
• 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 pulse generator to deliver electrical therapeutic stimulation tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses that result in creation and propagation (in both afferent and efferent directions) of action potentials within the cervical vagus nerve of a patient through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead. The neurostimulator also 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 system for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration, comprising:

a patient-operable external controller configured to transmit a plurality of unique signals comprising a unique signal associated with an up-titration command; and

an implantable neurostimulator comprising;

a pulse generator configured to deliver electrical therapeutic stimulation tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers comprising a cervical vagus nerve of a patient through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead; and

a recordable memory storing an autotitration operating mode comprising a maximum stimulation intensity and configured to increase an intensity of the delivered electrical therapeutic stimulation up to a level not exceeding the maximum stimulation intensity upon receipt of the unique signal associated with the up-titration command.

2. A system according to claim 1, further comprising:

an external programmer operable by a healthcare professional and configured to store the autotitration operating mode into the recordable memory.

3. A system according to claim 2, wherein the external programmer is further configured to receive at least one set of predefined stimulation parameters.

4. A system according to claim 3, wherein the external programmer is further operable by the healthcare professional to modify at least one parameter of the at least one set of predefined stimulation parameters based on the patient'"'"'s physiological requirements.

5. A system according to claim 1, wherein the plurality of the unique signals further comprises at least one of a unique signal indicating that the increased intensity of the electrical therapeutic stimulation is tolerable to the patient and a unique signal indicating that the increased intensity of the electrical therapeutic stimulation is not tolerable to the patient.

6. A system according to claim 5, wherein the autotitration operating mode is further configured to further increase the intensity to a level not exceeding the maximum stimulation intensity upon receipt of the unique signal indicating that the increased intensity of the electrical therapeutic stimulation is tolerable to the patient, and decrease the intensity upon receipt of the unique signal indicating that the increased intensity of the electrical therapeutic stimulation is not tolerable to the patient.

7. A system according to claim 5, wherein:

the intensity of the delivered electrical therapeutic stimulation comprises one or more parameters comprising an output current, frequency, duty cycle, and pulse width;

the autotitration operating mode is further configured to increase one of the parameters upon receipt of the unique signal associated with the up-titration command; and

upon receipt of the unique signal indicating that the increased intensity of the electrical therapeutic stimulation is not tolerable to the patient, decreasing the increased parameter and increasing another one of the parameters.

8. A system according to claim 1, wherein the autotitration operating mode is further configured to increase the intensity of the delivered therapeutic stimulation when the unique signal associated with the up-titration command is received in accordance with a predefined schedule comprised in the autotitration operating mode.

9. A system according to claim 8, wherein the predefined schedule comprises a permissible frequency of patient-controlled increases in intensity.

10. A system according to claim 8, wherein the predefined schedule comprises a period of time during which an up-titration command can be transmitted from the patient-operable external controller.

11. A system according to claim 1, further comprising:

a magnetic switch configured to control the pulse generator in response to receipt of one of the plurality of the unique signals,

wherein the unique signals are magnetic signals.

12. A system according to claim 1, further comprising:

a rechargeable battery comprised in the neurostimulator and configured to power the neurostimulator; and

an energy receiver configured to transcutaneously receive energy and recharge the rechargeable battery with the received energy.

13. A system according to claim 12, further comprising:

a state of charge gauge configured to measure the rechargeable battery'"'"'s state of charge.

14. A system according to claim 13, further comprising:

a patient feedback circuit configured to notify a user when the state of charge reaches a predetermined level.

15. A system according to claim 14, wherein the patient feedback circuit further configured to provide the state of charge in response to a request by an external programmer.

16. A system according to claim 12, further comprising:

an external energy generator configured to transcutaneously transmit the energy to the energy receiver.

17. A system according to claim 16, further comprising:

a first electromagnetic coil comprised in the energy receiver; and

a second electromagnetic coil comprised in the external energy generator.

18. A system according to claim 16, further comprising:

a photovoltaic cell comprised in the energy receiver; and

a light source comprised in the external energy generator.

19. A system according to claim 1, wherein the autotitration operating mode is further configured to continue delivery of the electrical therapeutic stimulation at the intensity up to the level not exceeding the maximum stimulation intensity regardless of receipt of additional signals uniquely 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.

20. A system according to claim 1, wherein:

the maximum stimulation intensity comprises one or more of an output current, a duty cycle, a frequency, and a pulse width,

the level of intensity of the delivered electrical therapeutic stimulation not exceeding the maximum stimulation intensity comprises one or more of an output current lower or equal to the maximum stimulation intensity output current, a duty cycle lower or equal to the maximum stimulation intensity duty cycle, a frequency lower or equal to the maximum stimulation intensity frequency, and a pulse width shorter or equal to the maximum stimulation intensity pulse width.