Therapeutic system and method using biphasic or multiphasic pulse waveform

• US 9,907,970 B2
• Filed: 03/18/2015
• Issued: 03/06/2018
• Est. Priority Date: 06/14/2013
• Status: Active Grant

• Current Assignee: CardioThrive, Inc.
• Original Assignee: CardioThrive, Inc.
• Inventors: Raymond, Douglas M., Gray, Peter D., Savage, Walter T., Savage, Shelley J.
• Primary Examiner(s): Patton, Amanda
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US14/662,165
• Publication Number:
  US 20160213933A1
• Time in Patent Office: 1,084 Days
• Field of Search: 607 59
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3912 Output circuitry therefor, e.g. switches

Abstract

A therapeutic signal delivery system and method that delivers a dynamically adjustable biphasic or multiphasic pulse are provided. The dynamically adjustable biphasic or multiphasic therapeutic pulse may be used for a variety of therapeutic treatments.

Claims

1. A medical device, comprising:

an energy source; and

a therapeutic signal generator coupled to the energy source having a first subsystem having a power source and an energy reservoir used to generate at least one first phase with a positive polarity and an independent subsystem having a second power source and a second energy reservoir used to generate at least one second phase with a negative and a switching component that switches between the first and independent subsystems to generate and deliver a therapeutic pulse waveform having at least one positive phase and at least one negative phase, wherein the first phase of the therapeutic pulse waveform has a smaller amplitude than an amplitude of the second phase of the therapeutic pulse waveform; and

at least two electrodes electrically connected to the therapeutic signal generator through which the therapeutic pulse waveform is delivered to a patient.

2. The device of claim 1, wherein the therapeutic pulse waveform delivers between 0.1 joules to 200 joules of energy to the patient during a therapeutic pulse waveform period of between 2 ms to 20 ms.

3. The device of claim 1, wherein the at least one first phase and the at least one second phase each have a set of characteristics, the set of characteristics comprising a first signal time and a first signal amplitude, a slope time and a slope value and a second signal time and a second signal amplitude and wherein the therapeutic signal generator is capable of adjusting any of the set of characteristics.

4. The device of claim 1, wherein the therapeutic pulse waveform has an inter-phase period between the at least one first phase and at least one second phase and wherein the therapeutic signal generator is capable of adjusting the inter-phase period.

5. The device of claim 1, wherein the energy source further comprises a subsystem that generates the at least one first phase and the at least one second phase, the subsystem having a plurality of power sources and a plurality of energy reservoirs and a control system coupled to the plurality of power sources and the plurality of energy reservoirs, wherein the control system allocates a first group of the power sources and energy reservoirs to generate the at least one first phase and allocates a second group of the power sources and energy reservoirs to generate the at least one second phase.

6. The device of claim 1, wherein the therapeutic pulse waveform is delivered to the patient during a period of less than 2 milliseconds.

7. The device of claim 1, wherein the therapeutic pulse waveform is delivered to the patient during a period of less than 1 microsecond.

8. The device of claim 1, wherein the therapeutic pulse waveform is a biphasic signal having one first phase and one second phase.

9. The device of claim 1, wherein the therapeutic pulse waveform is a multiphasic signal having a plurality of first phases and a plurality of second phases, wherein a first one of the first phase has a smaller amplitude than the plurality of second phases.

10. The device of claim 1, wherein the therapeutic pulse waveform stimulates a nerve of the patient.

11. The device of claim 1, wherein the therapeutic pulse waveform stimulates a muscle of the patient.

12. The device of claim 1, wherein the therapeutic pulse waveform provides neurological stimulation.

13. The device of claim 1, wherein the therapeutic pulse waveform provides defibrillation.

14. The device of claim 1, wherein the device is one of a wearable defibrillator, an implantable defibrillator and an external defibrillator.

15. The device of claim 1, wherein the therapeutic pulse waveform provides cardioversion.

16. The device of claim 1, wherein the therapeutic pulse waveform provides pacing.

17. The device of claim 1, wherein the therapeutic pulse waveform stimulates an organ of the patient.

34. The device of claim 1, wherein the independent subsystem is physically and electrically distinct from the first subsystem.

18. A method for delivering a therapeutic signal, comprising:

providing an energy source and a therapeutic signal generator coupled to the energy source, the therapeutic signal generator having a first subsystem that generates at least one first phase with a positive polarity and an independent subsystem that generates at least one second phase with a negative polarity;

generating, using the first subsystem having a power source and an energy reservoir, the at least one first phase;

generating, using the independent subsystem having a second power source and a second energy reservoir, the at least one second phase;

switching, using a switching component, between the first and second subsystems to generate and deliver a therapeutic pulse waveform having at least one positive phase and at least one negative phase, wherein the first phase of the therapeutic pulse waveform has a smaller amplitude than an amplitude of the second phase of the therapeutic pulse waveform; and

delivering the generated therapeutic pulse waveform to the patient.

19. The method of claim 18, wherein delivering the generated therapeutic pulse waveform further comprising delivering the therapeutic pulse waveform between 0.1 joules to 200 joules of energy to the patient during a therapeutic pulse waveform period of between 2 ms to 20 ms.

20. The method of claim 18, wherein the at least one first phase and the at least one second phase each have a set of characteristics, the set of characteristics comprising a first signal time and a first signal amplitude, a slope time and a slope value and a second signal time and a second signal amplitude and further comprising adjusting, by the therapeutic signal generator, any of the set of characteristics.

21. The method of claim 18, wherein the therapeutic pulse waveform has an inter-phase period between the at least one first phase and at least one second phase and further comprising adjusting, by the therapeutic signal generator, the inter-phase period.

22. The method of claim 18, wherein generating the therapeutic pulse waveform further comprises:

providing a subsystem that generates the at least one first phase and the at least one second phase, the subsystem having a plurality of power sources and a plurality of energy reservoirs;

allocating, by a control system that is coupled to the plurality of power sources and the plurality of energy reservoirs, a first group of the power sources and energy reservoirs to generate the at least one first phase; and

allocating, by the control system, a second group of the power sources and energy reservoirs to generate the at least one second phase.

23. The method of claim 18, wherein the therapeutic pulse waveform is delivered to the patient during a period of less than 2 milliseconds.

24. The method of claim 18, wherein the therapeutic pulse waveform is delivered to the patient during a period of less than 1 microsecond.

25. The method of claim 18, wherein the therapeutic pulse waveform is a biphasic signal having one first phase and one second phase.

26. The method of claim 18, wherein the therapeutic pulse waveform is a multiphasic signal having a plurality of first phases and a plurality of second phases, wherein a first one of the first phase has a smaller amplitude than the plurality of second phases.

27. The method of claim 18, wherein delivering the generated therapeutic pulse waveform to the patient further comprising delivering the therapeutic pulse waveform to the patient to stimulate a nerve of the patient.

28. The method of claim 18, wherein delivering the generated therapeutic pulse waveform to the patient further comprises delivering the therapeutic pulse waveform to the patient to stimulate a muscle of the patient.

29. The method of claim 18, wherein delivering the therapeutic pulse waveform to the patient to stimulate further comprises providing neurological stimulation.

30. The method of claim 18, wherein delivering the therapeutic pulse waveform to the patient to stimulate further comprises providing defibrillation.

31. The method of claim 18, wherein delivering the therapeutic pulse waveform to the patient to stimulate further comprises providing cardioversion.

32. The method of claim 18, wherein delivering the therapeutic pulse waveform to the patient to stimulate further comprises providing pacing.

33. The method of claim 18, wherein delivering the therapeutic pulse waveform to the patient to stimulate further comprises stimulating an organ of the patient.

35. The method of claim 18, wherein the independent subsystem is physically and electrically distinct from the first subsystem.