IP Library Granted Patent US 10,016,232
Granted Patent B1
US 10,016,232 · App. 15/794,717 · Granted Jul 10, 2018

Systems, devices, and methods for signal generation

Inventors: William Bowers (Westminster, CO); Raju Viswanathan (Mountain View, CA); Gary Long (Cincinnati, OH)
Assignee: Iowa Approach, Inc.
A61B18/1482A61B18/1233A61N1/05A61N1/327A61B2018/00577A61B2018/00613A61B2018/00708A61B2018/00988A61B2018/124A61B2018/1407A61B2018/1467
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Quick Facts
Patent No.
US 10,016,232
App. No.
15/794,717
Granted
Jul 10, 2018
Kind
B1
Abstract

Systems, devices, and methods for electroporation ablation therapy are disclosed, with the method including configuring a first sequence of subsets of one or more electrode channels of a signal generator as an anode sequence. Each electrode channel includes an electronic switch configured to switch between an ON state and an OFF state, and a drive circuit coupled to the electronic switch to control the state of the electronic switch. The method also includes configuring a second sequence of subsets of one or more electrode channels of the signal generator as a cathode sequence such that respective electrode channels of the first and second sequences are paired for energy delivery. The method also includes delivering, from an energy source, a pulse waveform to a set of electrodes via the paired sequences of electrode channels.

Claims (62)

1. A method, comprising:

configuring a first sequence of subsets of one or more electrode channels of a signal generator as an anode sequence, each electrode channel including:

a first electronic switch configured to switch between an ON state and an OFF state;

a second electronic switch configured to switch between an ON state and an OFF state;

a first drive circuit coupled to the first electronic switch to control the state of the first electronic switch; and

a second drive circuit coupled to the second electronic switch to control the state of the second electronic switch, the configuring further including setting the first electronic switch of each electrode channel of the first sequence to the ON state and setting the second electronic switch of each electrode channel of the first sequence to the OFF state;

configuring a second sequence of subsets of one or more electrode channels of the signal generator as a cathode sequence by setting the first electronic switch of each electrode channel of the second sequence to the ON state and setting the second electronic switch of each electrode channel of the second sequence to the OFF state such that respective electrode channels of the first and second sequences are paired for energy delivery;

delivering, at a first time from an energy source, a pulse waveform to a set of electrodes via the paired sequences of electrode channels, and wherein each pulse of the pulse waveform is a substantially DC pulse; and

 at a second time prior to the first time, for each electrode channel of the set of electrode channels:

conducting a first fault test, including:

setting the first electronic switch of that electrode channel to the ON state;

setting the second electronic switch of that electrode channel to the OFF state; and

classifying that electrode channel as passing the first fault test when substantially no current is detected in a sensing circuit;

conducting a second fault test, including:

setting the first electronic switch of that electrode channel to the OFF state;

setting the second electronic switch of that electrode channel to the ON state; and

classifying that electrode channel as passing the second fault test when substantially no current is detected in the sensing circuit.

2. The method of claim 1 , wherein each electronic switch includes an insulated-gate bipolar transistor.

3. The method of claim 1 , the method further including at least partially discharging a capacitive element included in the energy source when the signal generator is not in use.

4. The method of claim 1 , further comprising, at the second time:

conducting a third fault test, including:

setting the first electronic switch of that electrode channel to the ON state;

setting the second electronic switch of that electrode channel to the ON state; and

classifying that electrode channel as passing the third fault test when a predetermined amount of current is detected in the sensing circuit; and

classifying that electrode channel as working without fault when that electrode channel passes the first fault test, the second fault test, and the third fault test.

5. The method of claim 1 , the set of electrode channels including a linear array of N electrode channels, wherein the first sequence of subsets of electrode channels includes an electrode channel in the linear array of N electrode channels, and wherein the second sequence of subsets of electrode channels includes only electrode channels that do not correspond to any electrode channels adjacent to the first electrode channel in the linear array of N electrode channels.

6. The method of claim 1 , further comprising applying the pulse waveform to a patient in need thereof for treating atrial fibrillation via irreversible electroporation.

7. A method, comprising:

configuring a first sequence of subsets of one or more electrode channels of a signal generator as an anode sequence, each electrode channel including:

a first electronic switch configured to switch between an ON state and an OFF state;

a second electronic switch configured to switch between an ON state and an OFF state;

a first drive circuit coupled to the first electronic switch to control the state of the first electronic switch; and

a second drive circuit coupled to the second electronic switch to control the state of the second electronic switch, the configuring further including setting the first electronic switch of each electrode channel of the first sequence to the ON state and setting the second electronic switch of each electrode channel of the first sequence to the OFF state;

configuring a second sequence of subsets of one or more electrode channels of the signal generator as a cathode sequence by setting the first electronic switch of each electrode channel of the second sequence to the ON state and setting the second electronic switch of each electrode channel of the second sequence to the OFF state such that respective electrode channels of the first and second sequences are paired for energy delivery;

delivering, at a first time from an energy source, a pulse waveform to a set of electrodes via the paired sequences of electrode channels, and wherein each pulse of the pulse waveform is a substantially DC pulse; and

for each electrode channel of the set of electrode channels:

setting the first electronic switch to the ON state and setting the second electronic switch to the ON state for a predetermined duration of time to at least partially discharge the energy source, wherein the predetermined duration of time includes a set of pulse widths including a first pulse width, a second pulse width that is greater than the first pulse width, a third pulse width that is greater than the second pulse width, a fourth pulse width that is greater than the third pulse width, and a fifth pulse width that is greater than the fourth pulse width, the fifth pulse width being between about 15 μs and about 25 μs.

8. The method of claim 7 , wherein the first pulse width is between about 0.1 μs and about 1 μs, the second pulse width is between about 1 μs and about 5 μs, the third pulse width is between about 5 μs and about 10 μs, and the fourth pulse width is between about 10 μs and about 15 μs.

9. The method of claim 7 , further comprising applying the pulse waveform to a patient in need thereof for treating atrial fibrillation via irreversible electroporation.

10. A method, comprising:

configuring a first sequence of subsets of one or more electrode channels of a signal generator as an anode sequence, each electrode channel including:

a first electronic switch configured to switch between an ON state and an OFF state;

a second electronic switch configured to switch between an ON state and an OFF state;

a first drive circuit coupled to the first electronic switch to control the state of the first electronic switch; and

a second drive circuit coupled to the second electronic switch to control the state of the second electronic switch, the configuring further including setting the first electronic switch of each electrode channel of the first sequence to the ON state and setting the second electronic switch of each electrode channel of the first sequence to the OFF state;

configuring a second sequence of subsets of one or more electrode channels of the signal generator as a cathode sequence by setting the first electronic switch of each electrode channel of the second sequence to the ON state and setting the second electronic switch of each electrode channel of the second sequence to the OFF state such that respective electrode channels of the first and second sequences are paired for energy delivery;

delivering, at a first time from an energy source, a pulse waveform to a set of electrodes via the paired sequences of electrode channels, and wherein each pulse of the pulse waveform is a substantially DC pulse; and

for each electrode channel of the set of electrode channels:

setting the first electronic switch to the ON state and setting the second electronic switch to the ON state for a predetermined duration of time to at least partially discharge the energy source over a plurality of discharge cycles, each discharge cycle including partial discharge of each electrode channel of the set of electrode channels, wherein the predetermined duration of time includes a set of pulse widths including a first pulse width, a second pulse width that is greater than the first pulse width, a third pulse width that is greater than the second pulse width, a fourth pulse width that is greater than the third pulse width, and a fifth pulse width that is greater than the fourth pulse width, the fifth pulse width being between about 15 μs and about 25 μs.

11. The method of claim 10 , the energy source including a capacitive element and each electrode channel including a resistive element, further comprising at least partially discharging, via the resistive element, the capacitive element when the energy source is not in use.

12. The method of claim 10 , further comprising applying the pulse waveform to a patient in need thereof for treating atrial fibrillation via irreversible electroporation.

13. A method, comprising:

configuring a first sequence of subsets of one or more electrode channels of a signal generator as an anode sequence, each electrode channel including:

an electronic switch configured to switch between an ON state and an OFF state; and

a drive circuit coupled to the electronic switch to control the state of the electronic switch;

configuring a second sequence of subsets of one or more electrode channels of the signal generator as a cathode sequence such that respective electrode channels of the first and second sequences are paired for energy delivery; and

delivering, from an energy source, a pulse waveform to a set of electrodes via the paired sequences of electrode channels, and wherein each pulse of the pulse waveform is a substantially DC pulse, the pulse waveform including:

a first level of a hierarchy of the pulse waveform including a first set of pulses, each pulse having a pulse time duration, a first time interval separating successive pulses;

a second level of the hierarchy of the pulse waveform including a plurality of first sets of pulses as a second set of pulses, a second time interval separating successive first sets of pulses, the second time interval being at least three times the duration of the first time interval; and

a third level of the hierarchy of the pulse waveform including a plurality of second sets of pulses as a third set of pulses, a third time interval separating successive second sets of pulses, the third time interval being at least thirty times the duration of the second level time interval.

14. The method of claim 13 , further comprising applying the pulse waveform to a patient in need thereof for treating atrial fibrillation via irreversible electroporation.

15. The method of claim 13 , further comprising at least partially discharging a capacitive element included in the energy source when the signal generator is not in use.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2022
From: FARAPULSE, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 060802/0286 →
SECURITY INTEREST Recorded Aug 25, 2020
From: FARAPULSE, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 053596/0364 →
CHANGE OF NAME Recorded Jun 20, 2018
From: IOWA APPROACH, INC.
To: FARAPULSE, INC.
Reel/Frame 046397/0335 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2018
From: CINTRON MEDICAL, INC.
To: IOWA APPROACH, INC.
Reel/Frame 045668/0872 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2018
From: BOWERS, WILLIAM
To: CINTRON MEDICAL, INC.
Reel/Frame 045668/0709 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 19, 2018
From: VISWANATHAN, RAJU
To: IOWA APPROACH, INC.
Reel/Frame 045593/0678 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 19, 2018
From: GLL, LLC; LONG, GARY
To: IOWA APPROACH, INC.
Reel/Frame 045593/0712 →
Continuity (1)
Division 15499804 · Apr 27, 2017
Cited By (31)
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