# US 2024/0189016 A1 · Method and Apparatus for Precisely Controlling the Size and Shape of Radiofrequency Ablations

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- Number: US 2024/0189016 A1
- Document ID: US20240189016A1
- Status: Published application
- Kind: A1
- Application number: 18/582,615
- Filed: 2024-02-20
- Published: 2024-06-13
- Earliest claimed: 2011-10-15
- Assignees: Diros Technology Inc.
- Applicants: Diros Technology Inc.
- Inventors: Leslie William Organ; Peter George Darmos; Moshe Morrie Altmejd; George Peter Darmos; Ilya Gavrilov; Joel Ironstone
- Web page: https://patentgrep.com/patent/US20240189016A1

## CPC

- A61B 18/14: Probes or electrodes therefor
- A61B 18/1206: {Generators therefor}
- A61B 18/1477: {Needle-like probes}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00577: {Ablation}
- A61B 2018/00589: {Coagulation}
- A61B 2018/00654: {with individual control of each of a plurality of energy emitting elements}
- A61B 2018/0072: {Current}
- A61B 2018/00797: {measured by multiple temperature sensors}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/124: {switching the output to different electrodes, e.g. sequentially}
- A61B 2018/126: {bipolar}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Various embodiments of multielectrode radiofrequency (RF) ablation probes are described herein that disclose methods and apparatus for improved control and predictability of the size and shape of RF thermal electrocoagulations. The features of the invention include the ability to make irregularly shaped ablations in order to conform to irregularly shaped target tissue volumes, and to make very large ablations without the requirement for electrode cooling.

## Claims

### Claim 1

A system comprising:
an RF generator, and
a controller for multiple independent RF switch control,
wherein the controller is configured for repeating and/or reconfiguring a network topology of a number N of RF switch connections, SW1 to SWN, to a target at N target nodes for RF current flowing in a predetermined pattern, within a cycle and subsequent cycles by operably maintaining or changing connections to a plurality of electrodes to respond to temperature and heating requirements of any of the one or more electrodes at any instant; and wherein changing the connections causes RF current to flow in another predetermined pattern,
wherein at least one of the plurality of electrodes is connected to excitation voltage of the RF generator and two or more of the remaining two or more electrodes of the plurality of electrodes are combined to form a low impedance return path electrode for the RF current.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the controller is configured by software means to switch the connections to the plurality of electrodes between three states: current injection, current return, and disconnection.

### Claim 3 (depends on 1)

The system according to claim 1, further comprising: a first electrode set having first and second electrode groups, the first electrode group including one or more electrodes and the second electrode group including one or more electrodes; wherein the controller is configured for applying energy for a period of time to the first electrode set capable of forming a portion of the ablation; and repeating the step of applying energy to the first electrode set.

### Claim 4 (depends on 3)

The system according to claim 3, wherein the one or more electrodes of the second electrode group is a plurality of electrodes which is configured to create a reference electrode which, although not necessarily symmetric relative to the first electrode group, has a virtual position that can be predicted by their configuration relative to the first electrode group.

### Claim 5 (depends on 4)

The system according to claim 4, wherein the one or more electrodes of the second electrode group is a plurality of electrodes which is configured to create a virtual return path electrode whose position relative to the first electrode group can be predicted so that RF current can be directed from reaching areas where critical structures may be adversely affected.

### Claim 6 (depends on 3)

The system according to claim 3, wherein the first electrode group is one electrode and the controller is configured for precise and independent control of the temperature of the one electrode of the first electrode group by combining two or more electrodes of the second electrode group into a return path electrode group so that current density at each of the electrodes in the return path is small relative to the current density at the one electrode, so that, when a temperature change at the one electrode of the first electrode group is required, modification of RF current to it will minimally affect the low impedance return path electrode group because the change in current will be distributed over the return path electrode group.

### Claim 7 (depends on 3)

The system according to claim 3, wherein the controller is configured for applying energy to the first electrode set in a sufficiently short the period of time, so that only a small, incremental tissue ablation is made.

### Claim 8 (depends on 7)

The system according to claim 7, wherein the period of time for applying energy to the first electrode set is in the range of 10 milliseconds to 1500 milliseconds.

### Claim 9 (depends on 7)

The system according to claim 7, wherein the number of times of repeating the step of applying energy to the first electrode set is at least 100 times.

### Claim 10 (depends on 9)

The system according to claim 9, wherein the system further includes a second electrode set having first and second electrode groups, the first electrode group including one or more electrodes and the second electrode group including one or more electrodes, and wherein the controller is configured for applying energy to the second electrode set capable of forming a portion of the ablation; and wherein the time between the step of repeated applications of energy to the first and second electrode sets is sufficiently short, in the range of 10 milliseconds to 330 milliseconds, so that heat generated from the previous application does not decrease appreciably.

### Claim 11 (depends on 3)

The system according to claim 3, wherein the first electrode set being a first bipolar electrode set, and the system further includes:
a second bipolar electrode set having first and second electrode groups, wherein the first electrode group includes one or more electrodes and the second electrode group including one or more electrodes; and
wherein the controller is configured for: next applying energy for a period of time to the second electrode set capable of forming a portion of the ablation; and repeating the steps of applying energy to the first and second electrode sets.

### Claim 12 (depends on 11)

The system according to claim 11, wherein the period of time for applying energy to the first electrode set is in the range of 10 milliseconds to 1500 milliseconds, and wherein the period of time for applying energy to the second electrode set is in the range of 10 milliseconds to 1500 milliseconds.

### Claim 13 (depends on 12)

The system according to claim 12, wherein the frequency of repeating the steps of applying energy to the first and second electrode sets is in the range of one per second to 25 per second.

### Claim 14 (depends on 11)

The system according to claim 11, wherein the number of times of repeating the steps of applying energy to the first and second electrode sets is at least 100 times.

### Claim 15 (depends on 11)

The system according to claim 11, wherein the first and second electrode sets share at least one electrode.

### Claim 16 (depends on 11)

The system according to claim 11, wherein the one or more electrodes of the second electrode group of the first set of electrodes is a plurality of electrodes.

### Claim 17 (depends on 11)

The system according to claim 11, further including at least a third electrode set having first and second electrode groups, the first electrode group including one or more electrodes and the second electrode group including one or more electrodes; and wherein the controller is configured for using said first, second and third electrode sets in various combinations to create a three-dimensional, long, linear ablation volume and/or a three-dimensional non-linear ablation volume in order to conform in size and shape to a target volume.

### Claim 18 (depends on 11)

The system according to claim 11, wherein controller is configured for causing tissue ablation by thermal electrocoagulation during the steps of applying energy to the first electrode set and applying energy to the second electrode set.

### Claim 19 (depends on 11)

The system according to claim 11, wherein the controller is configured for applying energy to the first electrode set for a brief period of time capable of forming a small, incremental portion of a target ablation volume; and applying energy to the second electrode set for a brief, generally equal portion of time capable of forming a small, incremental portion of the target ablation volume; and repeating the steps of similarly applying energy to the first and second electrode sets so that ablation volume increases in at least 100 incremental steps in a controlled, predictable manner until the target ablation volume is reached.

### Claim 20 (depends on 19)

The system according to claim 19, wherein the first and second electrode groups are disposed with unequal lengths and/or in various directions at a distal end portion of at least one probe of the first electrode set, so that an irregular ablation volume can be created that generally matches the size and shape of the target ablation volume.

### Claim 21 (depends on 19)

The system according to claim 19, wherein the first and second electrode groups are disposed with unequal lengths and/or in various directions at a distal end portion of at least one probe of the first electrode set, so that an ablation volume can be created that is offset from the probe central longitudinal axis in order to be directed towards the target ablation volume.

### Claim 22 (depends on 19)

The system according to claim 19, wherein the first and second electrode groups are disposed with unequal lengths and/or in various directions at a distal end portion of at least one probe of the first electrode set, so that an ablation volume can be created that is offset from the probe central longitudinal axis in order to be directed towards the target ablation volume and away from adjacent structures that would be adversely affected if exposed to the ablation process.

### Claim 23 (depends on 19)

The system according to claim 19, wherein the second electrode group of the first electrode set includes two or more electrodes which creates a reference electrode which, although not necessarily symmetric relative to the first electrode group of the first electrode set, has a virtual position that can be predicted by their configuration relative to the first electrode group of the first electrode set.

### Claim 24 (depends on 19)

The system according to claim 19, wherein the second electrode group of the first electrode set includes two or more electrodes which creates a virtual return path electrode whose position relative to the first electrode group of the first electrode set can be predicted, and thereby allow 3-dimensional lesion volume to be created in a predictable manner.

### Claim 25 (depends on 19)

The system according to claim 19, wherein the controller is configured for using the virtual return path electrode to direct the flow of RF current so that RF current can be prevented from reaching areas where critical structures may be adversely affected.

### Claim 26 (depends on 19)

The system according to claim 19, wherein the first electrode group of the first electrode set is one electrode, wherein the controller is configured for controlling precisely and independently the temperature of the one electrode of the first electrode group by combining two or more electrodes of the second electrode group of the first electrode set into a return path electrode group so that current density at each of the electrodes in the return path is small relative to the current density at the one electrode of the first electrode group so that, when a temperature change at the one electrode of the first electrode group is required, modification of RF current to the one electrode of the first electrode group will minimally affect the low impedance return path electrode group because the change in current will be distributed over the return path electrode group.

### Claim 27

A system comprising:
an RF generator, including a controller for signal phase and amplitude control, wherein the controller is configured for controlling a network topology of a number N of proportional RF adders (Prop Adder 1, Prop Adder 2, . . . , Prop Adder N) connected to a target at N target nodes to provide essentially an infinite number of RF phase and amplitude combinations to the N target node connections for RF current flowing in a predetermined pattern; and wherein the controller is configured to repeatedly change the combinations within a target cycle to respond to temperature and heating requirements at an electrode and/or electrode group at any instant; and wherein changing the combinations causes RF current to flow in another predetermined pattern.

### Claim 28 (depends on 27)

The system according to claim 27, wherein the controller is configured by software means to switch the connections to the electrode and/or electrode group between three states: current injection, current return, and disconnection.

### Claim 29 (depends on 27)

The system according to claim 27, wherein the controller is configured to obtain changes in signal phase and amplitude without disconnecting any of the electrode connections.
