Systems and methods for avoiding neural stimulation habituation

1. A computer-implemented system comprising:

an external programmer, comprising:

a programming computer configured to execute using a processor program code that is stored in a memory, comprising:

a plurality of therapy routines stored in the memory that each comprise different sets of stimulation parameters that cooperatively define stimulation cycles of continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at a periodic duty cycle with an unchanging cycle not triggered by physiological markers in a manner that results in creation and propagation of action potentials within neuronal fibers comprising a vagus nerve of a patient to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes; and

a user interface comprising input controls and a visual display and configured to display the therapy routines to the patient and to select the set of stimulation parameters in the therapy profile chosen by the patient; and

an implantable neurostimulator configured to communicate with the external device, comprising a lead and electrically coupled to the neurostimulator, which is configured to therapeutically stimulate the vagus nerve through the lead by creating and propagating the action potentials with a pulse generator as specified by the selected set of stimulation parameters stored in the memory.

2. A system according to claim 1 , wherein the programming computer further comprises:

a plurality of therapeutic levels stored in the recordable memory that each comprise a plurality of intensity setting for the set of stimulation parameters in each of the therapy routines,

the user interface further configured to display the therapeutic levels to the user via the visual display and to modify the selected set stimulation parameters based on the intensity setting in the therapeutic level chosen by the patient,

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

3. A system according to claim 1 , wherein the lead comprises a connector pin electrically connected to electrodes by an electrical lead body and the neurostimulator is powered by a 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 pin is securely and electronically connected; and

the pulse generator configured to deliver electrical therapeutic stimulation to vagus nerve.

4. A system according to claim 1 , wherein the neurostimulator further comprises an integrated leadless heart rate sensor configured to sense the patient's heart rate during the stimulation cycles and to record the sensed heart rate as data into the recordable memory.

5. A system according to claim 1 , the neurostimulator further comprising:

a programmable switch configured to alter the creation and propagation of the action potentials by pulse generator in response to a magnetic signal received from outside the housing; and

the pulse generator further configured to trigger different modes stored in a recordable memory further comprising:

a stimulation mode configured to trigger the delivery of electrical therapeutic stimulation by the pulse generator for a fixed period of time in response to the magnetic signal; and

an inhibition mode configured to suspend the delivery of the electrical therapeutic stimulation by the pulse generator for a fixed period of time in response to the magnetic signal.

6. A system according to claim 1 , wherein the pulse generator is further configured to adjust output current, signal frequency, pulse width, signal ON time, and signal OFF time.

7. A computer-implemented method comprising:

storing a plurality of therapy routines in a memory of a programming computer, each therapy profile comprising different sets of stimulation parameters that cooperatively define stimulation cycles for a neurostimulator that include continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at a periodic duty cycle, 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 vagus nerve;

displaying the therapy routines to the patient and retrieving the set of stimulation parameters in the therapy profile selected by the patient; and

providing the selected set of stimulation parameters to the neurostimulator through wireless telemetry,

wherein the neurostimulator is configured to therapeutically stimulate a vagus nerve of the patient through a lead by creating and propagating the action potentials with the pulse generator as specified by the selected set of stimulation parameters stored in the memory.

8. A method according to claim 7 , further comprising:

storing a plurality of therapeutic levels in the memory, each therapeutic level comprising a plurality of intensity settings for the set of stimulation parameters in each of the therapy routines; and

displaying the therapeutic levels to the patient on the visual display and modifying the selected set of stimulation parameters based on the intensity setting in the therapeutic level chosen by the patient,

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

9. A method according to claim 7 , wherein the lead comprises a connector pin electrically connected to electrodes by an electrical lead body.

10. A method according to claim 7 , wherein the neurostimulator further comprises an integrated leadless heart rate sensor configured to sense the patient's heart rate during the stimulation cycles and to record the sensed heart rate as data into the recordable memory.

11. A method according to claim 7 , the neurostimulator further comprising:

a programmable switch configured to alter the creation and propagation of the action potentials by the pulse generator in response to a magnetic signal received from outside the housing; and

the pulse generator further configured to trigger different modes stored in a recordable memory further comprising:

a stimulation mode configured to trigger the delivery of electrical therapeutic stimulation by the pulse generator for a fixed period of time in response to the magnetic signal; and

an inhibition mode configured to suspend the delivery of the electrical therapeutic stimulation by the pulse generator for a fixed period of time in response to the magnetic signal.

12. A method according to claim 7 , wherein the pulse generator is further configured to adjust output current, signal frequency, pulse width. signal ON time, and signal OFF time.

13. An implantable device, comprising:

a lead, comprising;

a neurostimulator electrically coupled to the lead, the neurostimulator including;

a memory into which a therapy profile has been stored by an external programmer, the therapy profile comprising a set of stimulation parameters that cooperatively define alternating stimulation cycles of continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at a periodic duty cycle, 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 of action potentials within neuronal fibers comprising a cervical vagus nerve to both efferently activate the heart's intrinsic nervous method and afferently activate the patient's central reflexes; and

a pulse generator configured to therapeutically stimulate the vagus nerve through the lead based on the set of stimulation parameters in the therapy profile stored in the memory.

14. An implantable device according to claim 13 , further comprising:

an integrated leadless heart rate sensor configured to sense the patient's heart rate in response to the electrical therapeutic stimulation, wherein the pulse generator further configured to alter the creation and propagation of the action potentials in response to the sensed heart rate,

wherein the pulse generator is further configured to suspend the creation and propagation of the action potentials for a fixed period of time in response to the sensed heart rate, as sensed by the leadless heart rate sensors, falling below a lower bound of acceptable heart rates defined in the set of stimulation parameters, after which the creation and propagation of the action potentials resumes.

15. An implantable device according to claim 14 , wherein the lower bound of the acceptable heart rates is expressed as at least one ratio, a percentile, a function, and discrete independent values with respect to the sensed heart rate, as sensed by the leadless heart rate sensors.

16. An implantable device according to claim 14 , further comprising:

an integrated leadless heart rate sensor configured to sense the patient's heart rate and to alter the creation and propagation of the action potentials in response to the sensed heart rate,

wherein the pulse generator is further configured to gradually down titrate the creation and propagation of the action potentials in response to the sensed heart rate, as sensed by the leadless heart rate sensors, falling below a lower bound of the acceptable heart rates defined in the set of stimulation parameters.

17. An implantable device according to claim 16 , wherein the pulse generator is further configured to suspend the creation and propagation of the action potentials for a fixed period of time and gradually up titrate the creation and propagation of the action potentials after the down titration.

18. An implantable device according to claim 14 , further comprising:

an integrated leadless heart rate sensor configured to sense the patient's heart rate in response to the electrical therapeutic stimulation, wherein the pulse generator is further configured to alter the creation and propagation of the action potentials in response to the sensed heart rate,

wherein the pulse generator is further configured to gradually up titrate the creation and propagation of the action potentials in response to the sensed heart rate, as sensed by the leadless heart rate sensors, rising above the upper bound of the acceptable heart rates defined in the set of stimulation parameters.

19. An implantable device according to claim 18 , wherein the upper bound of the acceptable heart rates is expressed as at least one of a ratio, a percentile, a function, and discrete independent values with respect to the sensed heart rate, as sensed by the leadless heart rate sensors.

20. An implantable device according to claim 13 , wherein the pulse generator is further configured to adjust output current, signal frequency, pulse width, signal ON time, and signal OFF time.

21. An implantable device, comprising:

a lead; and

a neurostimulator including:

a memory into which a therapy profile has been stored by an external programmer, the therapy profile comprising a set of stimulation parameters that cooperatively define stimulation cycles of continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at a periodic duty cycle 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 of action potentials within neuronal fibers comprising a cervical vagus nerve to both efferently activate the heart's intrinsic nervous method and afferently activate the patient's central reflexes; and

a pulse generator configured to therapeutically stimulate the patient's vagus nerve using the set of stimulation parameters in the therapy profile stored in the recordable memory.

22. A vagus nerve neurostimulator, comprising:

an implantable neurostimulator comprising:

a pulse generator configured to deliver electrical therapeutic stimulation through continuously-cycling, intermittent and periodic electrical pulses with an unchanging cycle not triggered by physiological markers in both afferent and efferent directions of a vagus nerve through an electrically coupled 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.

23. A neurostimulator according to claim 22 , 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.

24. A neurostimulator according to claim 23 , wherein the duty cycle is less than approximately 50%.

25. A neurostimulator according to claim 22 , 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.

26. A neurostimulator according to claim 25 , wherein the stimulating parameters comprise the pulse width of 300 μsec, the output current falling within the range of 1.5 to 2.0 mA, and the signal frequency substantially comprising 20 HZ.

27. A neurostimulator according to claim 25 , wherein the pulse generator is further configured to automatically titrate the therapeutic dose to a target amplitude within a specified period of time preceding and following therapeutic stimulation at full output current.

28. An implantable device, comprising:

an implantable neurostimulator comprising a pulse generator configured to deliver electrical therapeutic stimulation 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 vagus nerve in stimulation cycles;

a lead electrically coupled to the pulse generator through which the therapeutic electrical stimulation is delivered to a vagus nerve; and

a leadless heart rate sensor configured to record heart rate while the electrical therapeutic stimulation is delivered by the pulse generator.

29. An implantable device according to claim 28 , further comprising:

stimulation parameters stored in a memory comprised with the pulse generator and defining a periodic duty cycle for the stimulation cycles that is less than approximately 50%.

30. An implantable device according to claim 28 , 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 of 300 μsec, an output current falling within the range of 1.5 to 2.0 mA, and a signal frequency substantially comprising 20 Hz.

31. An implantable device according to claim 28 , further comprising:

a connector pin and an electrical lead body that further comprise the therapy lead and which are electrically connected to 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.

32. An implantable device for providing electrical stimulation of vagus nerves, comprising:

a lead including:

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

a neurostimulator including:

a pulse generator configured to therapeutically stimulate the vagus nerve through the electrodes in cycles of stimulation 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 leadless heart rate sensor configured to sense the patient's heart rate during the alternating cycles of stimulation to record the sensed heart rate as data into a memory.

33. An implantable device according to claim 32 , wherein the pulse generator is further configured to define the cycles of stimulation through one or more of an adjustable output current, signal frequency, pulse width, signal ON time, and signal OFF time.

34. An implantable device according to claim 33 , wherein the pulse generator is further configured to automatically titrate the therapeutic dose to a target amplitude within a specified period of time respectively preceding and following therapeutic stimulation at full output current.

35. An implantable device according to claim 32 , wherein the neurostimulator further comprises:

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

36. An implantable device according to claim 32 , 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.

37. A computer-implemented system for providing electrical stimulation of vagus nerves, 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 cycles of stimulation for a pulse generator 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 vagus nerve to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes; and

an implantable neurostimulator configured to communicate with the external device to receive the set of parameters from the external device, comprising:

the pulse generator configured to use the set of stimulation parameters through a lead to to the vagus nerve; and

a leadless heart rate sensor configured to sense the patient's heart rate during the cycles of stimulation.

38. A system according to claim 37 , wherein the set of stimulation parameters define a periodic duty cycle for the cycles of stimulation that is less than approximately 50%.

39. A system according to claim 37 , wherein the set of stimulation parameters define the therapeutic electrical stimulation through a pulse width of 300 μsec, and output current falling within the range of 1.5 to 2.0 mA, and a signal frequency substantially comprising 20 Hz.

40. A system according to claim 37 , wherein the programming computer further comprises:

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

41. A system according to claim 37 , 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.

42. A vagus nerve neurostimulator, 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 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.

43. An implantable device, comprising:

an implantable neurostimulator comprising a pulse generator configured to modulate autonomic activity 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 non-selectively delivered in both afferent and efferent directions of a vagus nerve;

a lead electrically coupled to the pulse generator through which the therapeutic electrical stimulation is delivered to the vagus nerve; and

a leadless heart rate sensor configured to record heart rate while the electrical therapeutic stimulation is delivered by the pulse generator.