Multi-phasic signal for stimulation by an implantable device

• US 20060173493A1
• Filed: 01/28/2005
• Published: 08/03/2006
• Est. Priority Date: 01/28/2005
• Status: Abandoned Application

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K., Armstrong, Scott A.
• Application Number:
  US11/046,430
• Publication Number:
  US 20060173493A1
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

A method, system, and an apparatus for providing a multi-phasic stimulation signal for an implantable device are provided. An electrical pulse with a first characteristic that includes a first pulse width, a first pulse amplitude, a first pulse polarity, or a first pulse shape, is applied during a first time period to a portion of a vagus nerve using an implantable device. A controlled modification of the first characteristic of the electrical pulse is performed. The controlled modification is performed to provide a second characteristic for the electrical pulse during a second time period. The electrical pulse with the second characteristic is applied to the target portion of the vagus nerve.

Claims

1. A method for treating a patient with a multi-phasic stimulation signal from an implantable medical device (IMD), comprising:

applying an electrical pulse with a first controlled characteristic selected from the group consisting of a pulse width, a pulse amplitude, a pulse polarity, and a pulse shape, to a target portion of a vagus nerve using a pulse generator in a first phase defined by a first time period;

modifying said first controlled characteristic of said electrical pulse to provide a second controlled characteristic for said electrical pulse in a second phase defined by a second time period; and

applying said electrical pulse with said second controlled characteristic to said target portion of said vagus nerve.

2. The method of claim 1, wherein modifying said first controlled characteristic of said electrical pulse to provide a second controlled characteristic for said electrical pulse comprises changing at least one of said first amplitude, said first polarity, said first pulse width and said first pulse shape.

3. The method of claim 1, wherein modifying said first controlled characteristic of said electrical pulse further comprises acquiring a phasic pulse description.

4. The method of claim 1, further comprising:

modifying said second controlled characteristic of said electrical pulse to provide a third controlled characteristic for said electrical pulse in a third phase defined by a third time period; and

applying said electrical pulse with said third controlled characteristic to said target portion of said vagus nerve.

5. The method of claim 1, wherein modifying said first controlled characteristic further comprises initializing a second phase.

6. The method of claim 5, wherein initializing said second phase further comprises starting a phase timer and performing at least one of setting a pulse polarity, setting an amplitude, setting a pulse shape, setting a pulse duration and setting a combination of electrodes for said second phase.

7. The method of claim 6, further comprising terminating said second phase upon a time-expiration for said phase timer.

8. The method of claim 1, wherein applying said electrical pulse further comprises applying a pulse train signal to said vagus nerve, wherein at least two pulses in said train comprise controlled multi-phasic pulses.

9. A method for treating a patient with a multi-phasic stimulation signal from an implantable medical device (IMD), comprising:

providing an electrical pulse with a first controlled characteristic selected from the group consisting of a pulse width, a pulse amplitude, a pulse polarity, and a pulse shape;

applying said electrical pulse to a target portion of a vagus nerve during a first phase defined by a first time period;

changing said first controlled characteristic of the electrical pulse during a second phase defined by a second time period to provide a second controlled characteristic for said electrical pulse during a second time period; and

applying said electrical pulse with said second controlled characteristic during said second phase to said target portion of said vagus nerve.

10. An implantable medical device (IMD) for delivering a multi-phasic stimulation signal to a patient, comprising:

a stimulation unit to provide an electrical pulse during a first phase associated with a first time period to a target portion of a vagus nerve, said electrical pulse having a first controlled characteristic during said first time period, said first controlled characteristic comprising at least one of a first amplitude, a first polarity, a first pulse width, and a first pulse shape; and

a controller operatively coupled to said stimulation unit, said controller being adapted to direct said stimulation unit to apply said pulse having said first controlled characteristic to said target portion of the vagus nerve, the controller also being adapted to perform a controlled modification of said first controlled characteristic to generate a pulse with a second controlled characteristic during a second phase associated with a second time period, said second controlled characteristic comprising at least one of a second amplitude, a second polarity, a second pulse width, and a second pulse shape.

11. The implantable medical device of claim 10, wherein said stimulation unit further comprises a phase controller for providing a timing reference for the duration of said first and said second phases, said phase controller comprising a phase timer for providing said timing.

12. The implantable medical device of claim 11, further comprising a phasic pulse description array comprising data for providing at least one controlled characteristic for said signal during said first phase and for providing at least one controlled characteristic for said pulse during said second phase.

13. The implantable medical device of claim 12, further comprising a burst description array comprising data relating to a pulse train stimulation signal.

14. The implantable medical device of claim 10, wherein said controller is further adapted to modify said second controlled characteristic to provide a third controlled characteristic of said pulse during a third phase associated with a third time period, said third characteristic comprising at least one of a third amplitude, a third polarity, a third pulse width, and a third pulse shape.

15. The implantable medical device of claim 10, wherein said stimulation unit is adapted to hyper-polarize said target portion of said vagus nerve using said multi-phasic signal.

16. The implantable medical device of claim 10, wherein said stimulation unit is adapted to pre-polarize said target portion of said vagus nerve using said multi-phasic signal.

17. The implantable medical device of claim 10, further comprising a communication unit to provide communications with an external device.

18. The implantable medical device of claim 10, wherein said stimulation unit is capable of directing said electrical pulse to one or more electrodes associated with said implantable medical device.

19. The implantable medical device of claim 10, wherein said stimulation unit comprises circuitry adapted to perform an active discharge of charges associated with said electrical pulse.

20. The implantable medical device of claim 10, wherein said stimulation unit comprises circuitry adapted to perform a passive discharge of charges associated with said electrical pulse.

21. The implantable medical device claim of 10, wherein said first controlled characteristic comprises a first amplitude, a first polarity and a first pulse width, and said second controlled characteristic comprises a second amplitude, a second polarity and a second pulse width.

22. A computer readable program storage device encoded with instructions that, when executed by a computer, performs a method for treating a patient with a multi-phasic stimulation signal from an implantable medical device (IMD), comprising:

applying an electrical pulse with a first characteristic comprising at least one of a pulse width, a pulse amplitude, a pulse polarity, and a pulse shape, to a target portion of a vagus nerve using a pulse generator in a first time period;

performing a controlled modification of said first characteristic of said electrical pulse to provide a second characteristic for said electrical pulse during a second time period; and

applying said electrical pulse with said second characteristic to said target portion of said vagus nerve.

23. A method for treating a patient with a tri-phasic stimulation signal from an implantable medical device (IMD), comprising:

applying an electrical pulse to a target portion of a cranial nerve using a pulse generator, said electrical pulse comprising a first phase having a first characteristic, a second phase having a second characteristic, and a third phase having a third characteristic, wherein said first characteristic comprises at least one of a first amplitude, a first polarity, a first pulse width, and a first pulse shape, wherein said second characteristic comprises at least one of a second amplitude, a second polarity, a second pulse width, and a second pulse shape, and wherein said third characteristic comprises at least one of a third amplitude, a third polarity, a third pulse width, and a third pulse shape.

24. The method of claim 23, wherein said first characteristic comprises a first polarity, said second characteristic comprises a second polarity opposite said first polarity and said third characteristic comprises a third polarity opposite said second polarity.

25. The method of claim 23, wherein applying said electrical pulse further comprises digitally controlling said first characteristic.

26. The method of claim 25, wherein applying said electrical pulse further comprises digitally controlling said first, second and third characteristics.

27. The method of claim 23, wherein applying said electrical pulse during said third phase further comprises applying a charge-balance signal for balancing an electrical charge resulting from the electrical pulse from at least one of said first phase and said second phase.

28. The method of claim 23, wherein said cranial nerve comprises a vagus nerve.

29. The method of claim 23, wherein applying said electrical pulse to said target portion of said cranial nerve further comprises applying a controlled current pulse.

30. An implantable medical device (IMD) for delivering a multi-phasic stimulation signal to a patient, comprising:

a stimulation unit to provide an electrical pulse train to a target portion of a vagus nerve, said electrical pulse train comprising a first pulse having a first characteristic during a first time period, said first characteristic comprising at least one of a first amplitude, a first polarity, a first pulse width, and a first pulse shape; and

a controller operatively coupled to said stimulation unit, said controller being adapted to direct said stimulation unit to apply said pulse train having said first pulse to said target portion of the vagus nerve, the controller also being adapted to perform a controlled modification of said first characteristic to generate a second pulse with a second characteristic during a second time period, said second characteristic comprising at least one of a second amplitude different from said first amplitude, a second polarity different from said first polarity, a second pulse width different from said first pulse width and a second pulse shape different from said first pulse shape.

31. The implantable medical device of claim 30, said first characteristic comprising at least two of said first amplitude, said first polarity, said first pulse width, said first pulse shape, and said second characteristic comprising at least two of a second amplitude different from said first amplitude, a second polarity different from said first polarity, a second pulse width different from said first pulse width and a second pulse shape different from said first pulse shape.

32. The implantable medical device of claim 30, said controller being further adapted to perform at least one of a controlled frequency sweep and a random frequency sweep.

33. The implantable medical device of claim 30, said controller being further adapted to perform a controlled modification of said second characteristic to generate a third pulse with a third characteristic during a third time period, said third characteristic comprising at least one of a third amplitude different from said second amplitude, a third polarity different from said second polarity, a third pulse width different from said second pulse width and a third pulse shape different from said second pulse shape.

34. An implantable medical device (IMD) for delivering a tri-phasic stimulation signal to a cranial nerve of a patient, comprising:

a stimulation unit to provide to a target portion of a cranial nerve an electrical pulse comprising a first phase corresponding to a first time period and having a first characteristic, a second phase corresponding to a second time period and having a second characteristic, and a third phase corresponding to a third time period and having a third characteristic; and

a controller operatively coupled to said stimulation unit, said controller being adapted to direct said stimulation unit to apply said electrical pulse to said target portion of said cranial nerve.

35. The implantable medical device of claim 34, said stimulation unit further comprising a phase controller for providing a timing reference for the duration of at least one of said first phase, said second phase and said third phase.

36. The implantable medical device of claim 34, said phase controller further comprising a phase timer for providing said timing reference.

37. The implantable medical device of claim 34, wherein said first characteristic comprises a first polarity, said second characteristic comprises a second polarity opposite said first polarity and said third characteristic comprises a third polarity opposite said second polarity.

38. The implantable medical device of claim 34, wherein said third phase comprises a charge-balance signal for balancing an electrical charge resulting from the electrical pulse from at least one of said first phase and said second phase.

39. The implantable medical device of claim 34, wherein said cranial nerve comprises a vagus nerve.

40. A computer readable program storage device encoded with instructions that, when executed by a computer, performs a method for treating a patient with a tri-phasic stimulation signal from an implantable medical device (IMD), comprising:

applying an electrical pulse to a target portion of a cranial nerve using a pulse generator, said electrical pulse comprising a first phase corresponding to a first time period comprising a first characteristic, a second phase corresponding to a second time period comprising a second characteristic, and a third phase corresponding to a third time period comprising a third characteristic, wherein said first characteristic comprises a first polarity and at least one of a first amplitude, a first pulse width, and a first pulse shape, wherein said second characteristic comprises a second polarity opposite said first polarity and at least one of a second amplitude, a second pulse width, and a second pulse shape, and wherein said third characteristic comprises a third polarity opposite said second polarity and at least one of a third amplitude, a third pulse width and a third pulse shape.