Systems, devices, and methods for signal generation

Patent metadata

Field	Value
Publication number	US-11357978-B2
Application number	US-201916664496-A
Country	US
Kind code	B2
Filing date	Oct 25, 2019
Priority date	Apr 27, 2017
Publication date	Jun 14, 2022
Grant date	Jun 14, 2022

Abstract

Systems, devices, and methods for electroporation ablation therapy are disclosed, with the system including a pulse waveform signal generator for medical ablation therapy that may be coupled to an ablation device including at least one electrode for ablation pulse delivery to tissue. The signal generator may generate and deliver voltage pulses to the ablation device in the form of a pulse waveform in a predetermined sequence where the signal generator may independently configure a set of electrodes of an ablation device. The signal generator may further perform active monitoring of a set of electrode channels and discharge excess energy using the set of electrode channels.

First claim

The invention claimed is:

1. A system, comprising:
a set of electrodes; and
a signal generator configured to couple to the set of electrodes during use, the signal generator including:
a set of electrode channels, each electrode channel of the set of electrode channels including a first switch from a first set of switches and a second switch from a second set of switches, each switch of the first and second sets of switches configured to switch between an ON state and an OFF state;
a routing console configured to selectively couple each electrode channel of the set of electrode channels to an electrode of the set of electrodes during use;
an energy source coupled to a collector terminal of the first electronic switch of each electrode channel of the set of electrode channels;
a sensing circuit coupled to an emitter terminal of the second electronic switch of each electrode channel of the set of electrode channels via a resistive element;
a processor coupled to the set of electrode channels, the routing console, and the sensing circuit, the processor configured to:
configure a first subset of one or more electrode channels of the set of electrode channels as anodes by setting (1) the first switch of each electrode channel of the first subset of electrode channels to the ON state and (2) the second switch of each electrode channel of the first subset of electrode channels to the OFF state;
configure a second subset of one or more electrode channels of the set of electrode channels as cathodes by setting (1) the second switch of each electrode channel of the second subset of electrode channels to the ON state and (2) the first switch of each electrode channel of the second subset of electrode channels to the OFF state;
deliver, with the energy source and using the first and second subsets of electrode channels, a pulse waveform to a subset of electrodes coupled to the first and second subsets of electrode channels during use; and
detect, using the sensing circuit, an amount of current being delivered to the subset of electrodes.

2. The system of claim 1 , wherein the first and second switches of each electrode channel of the set of electrode channels include one of: bipolar junction transistors, bipolar Field Effect transistors (Bi-FET's), power Metal Oxide Semiconductor Field Effect Transistors (MOSFET's), and Insulated-Gate Bipolar Transistors (IGBT's).

3. The system of claim 1 , wherein the processor is further configured to detect, using the sensing circuit, electrical arcing during use.

4. The system of claim 1 , wherein the resistive element is configured to at least partially discharge a capacitive element of the energy source after the pulse waveform is delivered.

5. The system of claim 1 , wherein the processor is further configured to conduct a fault test by, for each electrode channel of the set of electrode channels:
setting the first switch of that electrode channel to one of the ON state or the OFF state and setting the second switch of that electrode channel to the other of the ON state or the OFF state;
delivering a direct current (DC) voltage to that electrode channel; and
classifying that electrode channel as failing the fault test when an amount of current detected by the sensing circuit is equal to or greater than a threshold value,
the processor configured to configure the first and second subsets of electrode channels to not include any electrode channels of the set of electrode channels classified as failing the fault test.

6. The system of claim 1 , wherein the processor is further configured to conduct a fault test for an electrode channel of the set of electrode channels by:
setting the first and second switches of that electrode channel to the ON state;
delivering a direct current (DC) voltage to that electrode channel; and
classifying that electrode channel as failing the fault test when a non-predetermined amount of current is detected by the sensing circuit,
the processor configured to configure the first and second subsets of electrode channels to not include any electrode channels of the set of electrode channels classified as failing the fault test.

7. The system of claim 1 , wherein the pulse waveform includes:
a first level of a hierarchy 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 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 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.

8. A system, comprising:
a set of electrodes; and
a signal generator configured to couple to the set of electrodes during use, the signal generator including:
a set of electrode channels, each electrode channel of the set of electrode channels including a first switch from a first set of switches and a second switch from a second set of switches, each switch of the first and second sets of switches configured to switch between an ON state and an OFF state;
a routing console configured to selectively couple each electrode channel of the set of electrode channels to an electrode of the set of electrodes during use;
an energy source coupled to a collector terminal of the first electronic switch of each electrode channel of the set of electrode channels;
a sensing circuit coupled to an emitter terminal of the second electronic switch of each electrode channel of the set of electrode channels via a resistive element;
a processor coupled to the set of electrode channels, the routing console, and the sensing circuit, the processor configured to:
configure a first sequence of subsets of one or more electrode channels of the set of electrode channels as an anode sequence;
configure a second sequence of subsets of one or more electrode channels of the set of electrode channels as a cathode sequence;
deliver, with the energy source and using respectively paired electrode channels of the first and second sequences of subsets of electrode channels, a pulse waveform to the set of electrodes based on a predetermined sequence; and
detect, via the sensing circuit, an amount of current being delivered to the set of electrodes.

9. The system of claim 8 , wherein the processor is configured to:
configure the first sequence of subsets of electrode channels to include an electrode channel from the set of electrode channels at a first time, and
configure the second sequence of subsets of electrode channels to include that electrode channel at a second time subsequent to the first time.

10. The system of claim 8 , wherein:
the processor is configured to configure the first sequence of subsets of electrode channels by:
setting the first switch of each electrode channel of the subsets of electrode channels to the ON state; and
setting the second switch of each electrode channel of the subsets of electrode channels to the OFF state, and

the processor is configured to configure the second sequence of subsets of electrode channels by:
setting the first switch of each electrode channel of the subsets of electrode channels to the OFF state; and
setting the second switch of each electrode channel of the subsets of electrode channels to the ON state.

11. The system of claim 8 , wherein the processor is further configured to detect, using the sensing

Assignees

• Farapulse Inc
• Boston Scient Scimed Inc

Inventors

• Bowers William
• Viswanathan Raju
• Long Gary

Classifications

• A61B2018/00988

  Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter · CPC title

• A61B18/1492

  having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence) · CPC title

• A61N1/327 Primary

  for enhancing the absorption properties of tissue, e.g. by electroporation · CPC title

• A61B2018/00708

  switching the power on or off · CPC title

• A61B2018/00267

  having a basket shaped structure · CPC title