Biphasic or multiphasic pulse generator and method

• US 9,656,094 B2
• Filed: 03/18/2015
• Issued: 05/23/2017
• Est. Priority Date: 06/14/2013
• Status: Active Grant

• Current Assignee: CardioThrive, Inc.
• Original Assignee: CardioThrive, Inc.
• Inventors: Gray, Peter D., Savage, Walter T., Savage, Shelley J., Raymond, Douglas M.
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/661,949
• Publication Number:
  US 20160206893A1
• Time in Patent Office: 797 Days
• Field of Search: 607 5, 607 9, 607 26, 607 70, 607 72, 607 74
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/39 Heart defibrillators
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3912 Output circuitry therefor, e.g. switches
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence

Abstract

A dynamically adjustable biphasic or multiphasic pulse generation system and method are provided. The dynamically adjustable biphasic or multiphasic pulse generator system may be used as a pulse generation system for a defibrillator or other type of electrical stimulation medical device.

Claims

1. A pulse generator, comprising:

a pulse waveform generator that generates a pulse waveform having at least one first phase of the pulse waveform and at least one second phase of the pulse waveform, wherein the first phase has an amplitude whose value is less than an amplitude of the second phase and wherein the first phase has a polarity and the second phase has an opposite polarity to the first phase;

at least a first subsystem that generates at least the first phase of the pulse waveform, the subsystem having a power source and an energy reservoir;

at least a second subsystem that generates at least the second phase of the pulse waveform, the second subsystem having a second power source and a second energy reservoir; and

a control logic unit that controls the first and second subsystems to generate the pulse waveform having the at least one first phase and the at least one second phase.

2. The generator of claim 1, wherein the control logic unit further comprises a switching component that switches between the first and second subsystems to generate the pulse waveform having the at least one first phase and the at least one second phase.

3. The generator of claim 1, wherein the generated pulse waveform has a plurality of first phases and a plurality of second phases to generate a multiphasic pulse waveform.

4. The generator of claim 1, wherein the generated pulse waveform has a single first phase and a single second phase to generate a biphasic pulse waveform.

5. The generator of claim 1, wherein the generated pulse waveform has the first phase that has a positive polarity and the second phase that has a negative polarity.

6. The generator of claim 1, wherein the generated pulse waveform has the first phase that has a negative polarity and the second phase that has a positive polarity.

7. The generator of claim 1, wherein the generated pulse waveform has an energy of between 0.1 to 200 joules of energy delivered to a patient during the first phase and second phase of the generated pulse waveform and an inter-pulse period between the first and second phases.

8. The generator of claim 7, wherein the energy of the generated pulse waveform is delivered to the patient during a 2 ms to 20 ms time period.

9. The generator of claim 1 further comprising an adjustment component that adjusts a slope of at least one phase of the pulse waveform or an amplitude of at least one phase of the pulse waveform.

10. The generator of claim 9, wherein the adjustment component is an array of capacitors wherein one or more capacitors are selected to adjust a slope of at least one phase of the pulse waveform or an amplitude of at least one phase of the pulse waveform.

11. The generator of claim 10, wherein the array of capacitors is one of capacitors connected in series, capacitors connected in parallel and capacitors connected in series and parallel.

12. The generator of claim 1 further comprising an array of capacitors that adjusts a slope of at least one phase of the pulse waveform.

13. The generator of claim 12, wherein the array of capacitors is one of capacitors connected in series, capacitors connected in parallel and capacitors connected in series and parallel.

14. The generator of claim 9, wherein the adjustment component is an array of resistors wherein one or more resistors are selected to adjust a slope of at least one phase of the pulse waveform or an amplitude of at least one phase of the pulse waveform.

15. The generator of claim 14, wherein the array of resistors is one of resistors connected in series, resistors connected in parallel and resistors connected in series and parallel.

16. The generator of claim 1, wherein the control logic unit adjusts a timing for at least one phase of the pulse waveform.

17. The generator of claim 16, wherein the control logic unit adjusts the timing for at least one phase of the pulse waveform based on a heart rhythm of a patient.

18. The generator of claim 1, wherein the control logic unit adjusts a timing of an inter-phase period between the first phase and the second phase of the pulse waveform.

19. The generator of claim 18, wherein the control logic unit adjusts the timing for the inter-phase period based on a heart rhythm of a patient.

20. A biphasic or multiphasic pulse generator, comprising:

a pulse waveform generator that generates a pulse waveform having at least one first phase of the pulse waveform and at least one second phase of the pulse waveform, wherein the first phase has an amplitude whose value is less than an amplitude of the second phase and wherein the first phase has a polarity and the second phase has an opposite polarity to the first phase;

a first subsystem that generates at least the first phase and the second phase of the pulse waveform, the first subsystem having an array of power sources and an array of energy reservoirs that are capable of being allocated into a first group and a second group in order to separately generate the first and second phases of the pulse waveform using the first and second groups, respectively, of the first subsystem; and

a control logic unit that controls the allocation of the first and second groups from the first subsystem to generate the pulse waveform having the at least one first phase and the at least one second phase.

21. The generator of claim 20, wherein the control logic unit further comprises a switching component that switches between the first group and second group of the first subsystem to generate the pulse waveform having the at least one first phase and the at least one second phase.

22. The generator of claim 20, wherein the generated pulse waveform has a plurality of first phases and a plurality of second phases to generate a multiphasic pulse waveform.

23. The generator of claim 20, wherein the generated pulse waveform has a single first phase and a single second phase to generate a biphasic pulse waveform.

24. The generator of claim 20, wherein the generated pulse waveform has the first phase that has a positive polarity and the second phase that has a negative polarity.

25. The generator of claim 20, wherein the generated pulse waveform has the first phase that has a negative polarity and the second phase that has a positive polarity.

26. The generator of claim 20, wherein the generated pulse waveform has an energy of between 0.1 to 200 joules of energy delivered to a patient during the first phase and second phase of the generated pulse waveform and an inter-pulse period between the first and second phases.

27. The generator of claim 26, wherein the energy of the generated pulse waveform is delivered to the patient during a 2 ms to 20 ms time period.

28. The generator of claim 20 further comprising an adjustment component that adjusts a slope of at least one phase of the pulse waveform or an amplitude of at least one phase of the pulse waveform.

29. The generator of claim 28, wherein the adjustment component is an array of capacitors wherein one or more capacitors are selected to adjust a slope of at least one phase of the pulse waveform or an amplitude of at least one phase of the pulse waveform.

30. The generator of claim 29, wherein the array of capacitors is one of capacitors connected in series, capacitors connected in parallel and capacitors connected in series and parallel.

31. The generator of claim 20 further comprising an array of capacitors that adjusts a slope of at least one phase of the pulse waveform.

32. The generator of claim 31, wherein the array of capacitors is one of capacitors connected in series, capacitors connected in parallel and capacitors connected in series and parallel.

33. The generator of claim 28, wherein the adjustment component is an array of resistors wherein one or more resistors are selected to adjust a slope of at least one phase of the pulse waveform or an amplitude of at least one phase of the pulse waveform.

34. The generator of claim 33, wherein the array of resistors is one of resistors connected in series, resistors connected in parallel and resistors connected in series and parallel.

35. The generator of claim 20, wherein the control logic unit adjusts a timing for at least one phase of the pulse waveform.

36. The generator of claim 35, wherein the control logic unit adjusts the timing for at least one phase of the pulse waveform based on a heart rhythm of a patient.

37. The generator of claim 20, wherein the control logic unit adjusts a timing of an inter-phase period between the first phase and the second phase of the pulse waveform.

38. The generator of claim 37, wherein the control logic unit adjusts the timing for the inter-phase period based on a heart rhythm of a patient.

39. A method for generating a therapeutic pulse waveform, comprising:

generating at least one first phase of a pulse waveform using at least a first subsystem having a power source and an energy reservoir to generate the at least one first phase;

generating at least one second phase of the pulse waveform using at least a second subsystem having a second power source and a second energy reservoir to generate the at least one second phase, wherein the at least one first phase of the pulse waveform is smaller in amplitude than the amplitude of the at least one second phase of the pulse waveform and wherein the first phase has a polarity and the second phase has an opposite polarity to the first phase; and

controlling a selection of the at least one first phase and the at least one second phase to generate the pulse waveform having the at least one first phase and the at least one second phase.

40. The method of claim 39, wherein controlling the selection of the at least one first pulse and the at least one second pulse further comprises switching, using a switching component, between at least one first phase and the at least one second phase to generate the pulse waveform.

41. The method of claim 39, wherein the generated pulse waveform has a plurality of first phases and a plurality of second phases to generate a multiphasic pulse waveform.

42. The method of claim 39, wherein the generated pulse waveform has a single first phase and a single second phase to generate a biphasic pulse waveform.

43. The method of claim 39, wherein the generated pulse waveform has the first phase that has a positive polarity and the second phase that has a negative polarity.

44. The method of claim 39, wherein the generated pulse waveform has the first phase that has a negative polarity and the second phase that has a positive polarity.

45. The method of claim 39, wherein the generated pulse waveform has an energy of between 0.1 to 200 joules of energy delivered to a patient during the first phase and second phase of the generated pulse waveform and an inter-pulse period between the first and second phases.

46. The method of claim 45, wherein the energy of the generated pulse waveform is delivered to the patient during a 2 ms to 20 ms time period.

47. The method of claim 39 further comprising adjusting a slope of at least one phase of the pulse waveform or an amplitude of at least one phase of the pulse waveform.

48. The method of claim 39 further comprising adjusting a timing for at least one phase of the pulse waveform.

49. The method of claim 48, wherein adjusting the timing for at least one phase of the pulse waveform further comprises taking a heart rhythm from a patient and adjusting the timing for at least one phase of the pulse waveform based on the heart rhythm of the patient.

50. The method of claim 39 further comprising adjusting a timing of an inter-phase period between the first phase and the second phase of the pulse waveform.

51. The method of claim 50, wherein adjusting the timing of the inter-phase period further comprises taking a heart rhythm from a patient and adjusting the timing of the inter-phase period based on the heart rhythm of the patient.