Implantable device for facilitating control of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction

• US 8,600,505 B2
• Filed: 12/07/2011
• Issued: 12/03/2013
• 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:
  US13/314,130
• Publication Number:
  US 20130158622A1
• Time in Patent Office: 727 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 1/37217 characterised by the communication link, e.g. acoustic or tactile

Abstract

An implantable device for facilitating control of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction 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 a programmable switch configured to alter the triggering of the bi-directional action potentials in response to a magnetic signal received from outside the housing.

Claims

1. An externally-controllable vagus nerve neurostimulator for treating chronic cardiac dysfunction, 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 programmable switch configured to control the pulse generator in response to a remotely-applied magnetic signal.

2. A neurostimulator according to claim 1, wherein the pulse generator is further configured to suspend the electrical therapeutic stimulation for a fixed period of time in response to the magnetic signal.

3. A neurostimulator according to claim 2, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals, each magnetic signal corresponding to different durations of the fixed period of time.

4. An externally-controllable implantable device for treating chronic cardiac dysfunction, 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 affects 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

a programmable switch configured to control the therapeutic electrical stimulation via the pulse generator in response to an external magnetic signal.

5. An implantable device according to claim 4, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals and to suspend the electrical therapeutic stimulation for different durations of fixed periods of time in response to the respective magnetic signal.

6. An implantable device for facilitating control of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction, 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

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.

7. An implantable device according to claim 6, wherein the pulse generator is further configured to suspend the triggering of the bi-directional action potentials for a fixed period of time in response to the magnetic signal.

8. An implantable device according to claim 7, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals, each magnetic signal corresponding to different durations of the fixed period of time.

9. An implantable device according to claim 6, wherein the pulse generator is further configured to either reset or test the pulse generator in response to the magnetic signal.

10. An implantable device according to claim 6, further comprising:

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

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

a computer system configured to execute a software application that provides guided instructions to the patient in conjunction with use of the patient magnet on the neurostimulator.

12. A vagus nerve neurostimulator with autotitration for treating chronic cardiac dysfunction, 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 programmable switch configured to trigger automatic titration of the electrical therapeutic stimulation progressively over a fixed period of time in response to a remotely-applied magnetic signal.

13. A neurostimulator according to claim 12, wherein the pulse generator is further configured to suspend the electrical therapeutic stimulation for a fixed period of time in response to the magnetic signal.

14. A neurostimulator according to claim 13, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals, each magnetic signal corresponding to different durations of the fixed period of time.

15. An implantable device with autotitration for treating chronic cardiac dysfunction, 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

a programmable switch configured to trigger automatic titration of the therapeutic electrical stimulation progressively over a fixed period of time in response to an external magnetic signal.

16. An implantable device according to claim 15, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals and to suspend the electrical therapeutic stimulation for different durations of fixed periods of time in response to the respective magnetic signal.

17. An implantable device for triggering autotitration of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction, 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

a programmable switch configured to trigger automatic titration of the bi-directional action potentials into a predetermined set of stimulation parameters progressively over a fixed period of time in response to a magnetic signal received from outside the housing.

18. An implantable device according to claim 17, further comprising:

a recordable memory within which is stored the predetermined stimulation parameters set,

wherein the pulse generator is further configured to operate under the predetermined stimulation parameters set stored in the recordable memory.

19. An implantable device according to claim 18, wherein the predetermined stimulation parameters set comprises at least one of an amplitude, pulse width, frequency, train length, and duty cycle to define a therapeutic regimen for the patient.

20. An implantable device according to claim 17, wherein the pulse generator is further configured to adjust the bi-directional action potentials to the levels specified in the predetermined stimulation parameters set in increments spread out over time.

21. An implantable device according to claim 17, further comprising:

a recordable memory within which is stored a plurality of sets of predetermined stimulation parameters, each set of the predetermined stimulation parameters corresponding to a different magnet signal,

wherein the programmable switch is further configured to recognize the different magnetic signals and the pulse generator is further configured to operate under the predetermined stimulation parameters set stored in the recordable memory that corresponds to the magnetic signal recognized by the programmable switch.

22. An implantable device according to claim 17, wherein the pulse generator is further configured to suspend the triggering of the bi-directional action potentials for a fixed period of time in response to the magnetic signal, after which the triggering of the bi-directional action potentials resumes.

23. An implantable device according to claim 17, wherein the pulse generator is further configured to gradually down titrate the triggering of the bi-directional action potentials in response to the magnetic signal.

24. An implantable device according to claim 23, wherein the pulse generator is further configured to suspend the triggering of the bi-directional action potentials for a fixed period of time and gradually up titrate the triggering of the bi-directional action potentials after the down titration.

25. An implantable device according to claim 17, further comprising:

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

26. An implantable device according to claim 25, further comprising:

a computer system configured to execute a software application that provides guided instructions to the patient in conjunction with use of the patient magnet on the neurostimulator.