Biphasic or multiphasic pulse waveform and method

• US 10,870,012 B2
• Filed: 11/13/2017
• Issued: 12/22/2020
• 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): Hulbert, Amanda K
• Assistant Examiner(s): Edwards, Philip C
• Application Number:
  US15/811,427
• Publication Number:
  US 20180064948A1
• Time in Patent Office: 1,135 Days
• Field of Search: 607 59
• CPC Class Codes: A61N 1/3625 External stimulators
• 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

Abstract

A novel therapeutic biphasic or multiphasic pulse waveform and method are provided. The novel therapeutic biphasic or multiphasic pulse waveform may be used in a defibrillator, or in another medical device that delivers therapeutic electrical stimulation pulses to a patient.

Claims

1. A system for generating a therapeutic waveform, comprising:

a pulse waveform generator that generates a waveform with a length of 1-20 ms and having at least one first phase having a first polarity and at least one second phase having a second polarity opposite of the first polarity, the at least one first phase having a leading edge, a trailing edge and a decay slope between the leading edge and the trailing edge and the decay slope having a phase tilt, the at least one second phase having a leading edge, a trailing edge and a decay slope between the leading edge and the trailing edge and the decay slot having a phase tilt; and

wherein an amplitude of the leading edge of the at least one first phase of the waveform is less than an amplitude of the leading edge of the at least one second phase of the waveform and a phase timing of the at least one first phase is less than a phase timing of the at least one second phase.

2. The system of claim 1, wherein the waveform has a plurality of first phases and a plurality of second phases that form a multiphasic waveform.

3. The system of claim 2, wherein the multiphasic waveform has alternating first phases and second phases.

4. The system of claim 2, wherein the multiphasic waveform has the plurality of first phases followed by the plurality of second phases.

5. The system of claim 1, wherein the waveform has a single first phase and a single second phase of a biphasic waveform.

6. The system of claim 1, wherein the first phase has a positive polarity and the second phase has a negative polarity.

7. The system of claim 1, wherein the first phase has a negative polarity and the second phase has a positive polarity.

8. The system of claim 1, wherein the waveform has an inter-phase period between the first phase and the second phase with a duration of between 0 and 1500 microseconds.

9. The system of claim 1, wherein the phase tilt of the at least one first phase is the same as the phase tilt of the at least one second phase.

10. The system of claim 1, wherein the phase tilt of the at least one first phase is different from the phase tilt of the at least one second phase.

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

generating, by the pulse waveform generator, a waveform with a length of 1-20 ms and having at least one first phase having a first polarity and at least one second phase having a second polarity opposite of the first polarity, wherein the first phase of the waveform has an amplitude that is less than an amplitude of the second phase of the waveform;

controlling a duration and a shaping of each phase of the waveform, the controlling further comprising generating the at least one first phase having a leading edge, a trailing edge and a decay slope between the leading edge and the trailing edge and the decay slope having a phase tilt and generating the at least one second phase having a leading edge, a trailing edge and a decay slope between the leading edge and the trailing edge and the decay slot having a phase tilt; and

wherein generating the waveform further comprises generating a waveform in which a phase timing of the at least one first phase is less than a phase timing of the at least one second phase.

12. The method of claim 11, wherein generating the waveform further comprises forming a multiphasic waveform having a plurality of first phases and a plurality of second phases.

13. The method of claim 12, wherein the multiphasic waveform has alternating first phases and second phases.

14. The method of claim 12, wherein the multiphasic waveform has the plurality of first phases followed by the plurality of second phases.

15. The method of claim 11, wherein generating the waveform further comprises forming a biphasic waveform having a single first phase and a single second phase.

16. The method of claim 11, wherein the first phase has a positive polarity and the second phase has a negative polarity.

17. The method of claim 11, wherein the first phase has a negative polarity and the second phase has a positive polarity.

18. The method of claim 11, wherein generating the waveform further comprises having an inter-phase period between the first phase and the second phase with a duration of between 0 and 1500 microseconds.

19. The method of claim 11, wherein the phase tilt of the at least one first phase is the same as the phase tilt of the at least one second phase.

20. The method of claim 11, wherein the phase tilt of the at least one first phase is different from the phase tilt of the at least one second phase.