Implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with leadless heart rate monitoring

• US 8,577,458 B1
• Filed: 12/07/2011
• Issued: 11/05/2013
• Est. Priority Date: 12/07/2011
• 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): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US13/314,126
• Time in Patent Office: 699 Days
• Field of Search: 607/27, 607/9, 607/118
• US Class Current: 607/27
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with leadless heart rate monitoring is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. A neurostimulator includes an electrical receptacle into which the connector pins are securely and electrically coupled. The neurostimulator also includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart'"'"'s intrinsic nervous system and afferently activate the patient'"'"'s central reflexes by triggering bi-directional action potentials. Finally, the neurostimulator includes an integrated leadless heart rate sensor configured to sense heart rate and to record the sensed heart rate as data into a memory.

Claims

1. A vagus nerve neurostimulator for treating chronic cardiac dysfunction with leadless heart rate monitoring, comprising:

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 both afferent and efferent directions of a cervical vagus nerve through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead; and

a leadless heart rate sensor configured to sense and record heart rate while the electrical therapeutic stimulation is delivered by the pulse generator without influencing how the electrical therapeutic stimulation is tuned and delivered.

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

stimulation parameters stored in a memory comprised with the pulse generator and defining a periodic duty cycle comprising a percentage of time that the pulse generator is delivering the electrical therapeutic stimulation.

3. A neurostimulator according to claim 2, wherein the duty cycle falls within the range of 5% to 30%.

4. A neurostimulator according to claim 1, further comprising:

stimulation parameters stored in a memory comprised with the pulse generator and configured to configured to define the therapeutic electrical stimulation through one or more of an adjustable output current, signal frequency, pulse width, signal ON time, and signal OFF time.

5. A neurostimulator according to claim 4, wherein the stimulating parameters comprise the pulse width falling within the range of 100 to 250 μ

sec, the output current falling within the range of 0.02 to 50 mA, and the signal frequency substantially comprising 20 Hz.

6. A neurostimulator according to claim 4, wherein the pulse generator is further configured to provide at least one of a ramp-up time during which the output current is progressively increased and a ramp-down time during which the output current is progressively decreased respectively preceding and following therapeutic stimulation at full output current.

7. An implantable device for treating chronic cardiac dysfunction with leadless heart rate monitoring, comprising:

an implantable neurostimulator comprising a pulse generator configured to deliver electrical therapeutic stimulation tuned to restore autonomic balance at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered in both afferent and efferent directions of a cervical vagus nerve in continuous alternating cycles of stimuli application and stimuli inhibition;

a cervical vagus nerve stimulation therapy lead electrically coupled to the pulse generator and terminated by a pair of helical electrodes through which the therapeutic electrical stimulation is delivered to the cervical vagus nerve; and

an integrated leadless heart rate sensor configured to monitor and continually record heart rate while the electrical therapeutic stimulation is delivered by the pulse generator without influencing how the electrical therapeutic stimulation is tuned and delivered.

8. An implantable device according to claim 7, further comprising:

stimulation parameters stored in a memory comprised with the pulse generator and defining a periodic duty cycle for the alternating cycles of stimuli application and stimuli inhibition that falls within the range of 5% to 30%.

9. An implantable device according to claim 7, further comprising:

stimulation parameters stored in a memory comprised with the pulse generator and configured to define the therapeutic electrical stimulation through a pulse width falling within the range of 100 to 250 μ

sec, an output current falling within the range of 0.02 to 50 mA, and a signal frequency substantially comprising 20 Hz.

10. An implantable device according to claim 7, further comprising:

a connector pin and an insulated electrical lead body that further comprise the therapy lead and which are electrically connected to the helical electrodes; and

an electrical receptacle comprised on an outer surface of the neurostimulator into which the connector pin is securely and electrically connected to the pulse generator.

11. An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with leadless heart rate monitoring, comprising:

a cervical vagus nerve stimulation therapy lead, comprising;

a pair of helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath of a patient; and

a set of connector pins electrically connected to the helical electrodes by an insulated electrical lead body; and

a neurostimulator powered by a primary battery and enclosed in a hermetically sealed housing, further comprising;

an electrical receptacle comprised on an outer surface of the housing into which the connector pins are securely and electrically coupled;

a pulse generator configured to therapeutically stimulate the cervical vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to restore autonomic balance at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered in both afferent and efferent directions of the vagus nerve to both efferently activate the heart'"'"'s intrinsic nervous system and afferently activate the patient'"'"'s central reflexes by triggering bi-directional action potentials; and

an integrated leadless heart rate sensor configured to sense the patient'"'"'s heart rate during the alternating cycles of stimuli application and stimuli inhibition without influencing how the electrical therapeutic stimulation is tuned and delivered and to record the sensed heart rate as data into a memory.

12. An implantable device according to claim 11, wherein the pulse generator is further configured to define the alternating cycles of stimuli application and stimuli inhibition through one or more of an adjustable output current, signal frequency, pulse width, signal ON time, and signal OFF time.

13. An implantable device according to claim 12, wherein the pulse generator is further configured to provide at least one of a ramp-up time during which the output current is progressively increased and a ramp-down time during which the output current is progressively decreased respectively preceding and following therapeutic stimulation at full output current.

14. An implantable device according to claim 11, wherein the neurostimulator further comprises:

an analyzer configured to access and generate heart rate statistics from the sensed heart rate data in the memory.

15. An implantable device according to claim 14, wherein the heart rate statistics comprise one or more of a minimum heart rate over a stated time period, a maximum heart rate over a stated time period, an average heart rate over a stated time period, and a variability of heart rate over a stated period.

16. An implantable device according to claim 11, wherein the helical electrodes are further configured as at least one of a monopolar cathode, a proximal anode and a distal cathode, and a proximal cathode and a distal anode.

17. A computer-implemented system for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with leadless heart rate monitoring, comprising:

an external programmer, comprising;

a programming computer configured to execute using a processor program code that is stored in a memory and comprising a set of stimulation parameters stored in the memory that cooperatively define alternating cycles of stimuli application and stimuli inhibition for a pulse generator that are tuned to restore autonomic balance at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered in both afferent and efferent directions of a cervical vagus nerve to both efferently activate the heart'"'"'s intrinsic nervous system and afferently activate the patient'"'"'s central reflexes; and

a programming wand interfaced to the programming computer and configured to provide the set of stimulation parameters to the pulse generator through wireless telemetry; and

an implantable neurostimulator comprising;

the pulse generator, which is configured to drive electrical therapeutic stimulation as specified by the set of stimulation parameters, and a cervical vagus nerve stimulation therapy lead terminated by a pair of helical electrodes and electrically coupled to the neurostimulator through which the electrical therapeutic stimulation is delivered to the cervical vagus nerve; and

an integrated leadless heart rate sensor configured to sense the patient'"'"'s heart rate during the alternating cycles of stimuli application and stimuli inhibition without influencing how the electrical therapeutic stimulation is tuned and delivered and to record the sensed heart rate as data into a memory.

18. A system according to claim 17, wherein the set of stimulation parameters define a periodic duty cycle for the alternating cycles of stimuli application and stimuli inhibition that falls within the range of 5% to 30%.

19. A system according to claim 17, wherein the set of stimulation parameters define the therapeutic electrical stimulation through a pulse width falling within the range of 100 to 250 μ

sec, an output current falling within the range of 0.02 to 50 mA, and a signal frequency substantially comprising 20 Hz.

20. A system according to claim 17, wherein the programming computer further comprises:

an analyzer configured to retrieve the sensed heart rate data from the memory of the neurostimulator and generate heart rate statistics.

21. A system according to claim 20, wherein the heart rate statistics comprise one or more of a minimum heart rate over a stated time period, a maximum heart rate over a stated time period, an average heart rate over a stated time period, and a variability of heart rate over a stated period.

22. A system according to claim 17, wherein the neurostimulator further comprises a programmable switch configured to alter the triggering of the bi-directional action potentials by the pulse generator in response to a magnetic signal received from outside the housing.

23. A system according to claim 22, further comprising:

a patient magnet configured to provide the magnetic signal when placed outside a patient'"'"'s body in proximity to the neurostimulator.