# US 2025/0143783 A1 · Ablation catheter and operation method of same

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- Number: US 2025/0143783 A1
- Document ID: US20250143783A1
- Status: Published application
- Kind: A1
- Application number: 19/018,972
- Filed: 2025-01-13
- Published: 2025-05-08
- Earliest claimed: 2021-01-22
- Assignees: CRC EP, Inc.
- Applicants: CRC EP, Inc.
- Inventors: Dorin PANESCU; Cary HATA; Alan DE LA RAMA; Henning EBERT; Steffen HOLZINGER
- Web page: https://patentgrep.com/patent/US20250143783A1

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/1206: {Generators therefor}
- A61B 18/1233: {with circuits for assuring patient safety}
- A61B 2017/00053: {Mapping}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00166: {Multiple lumina}
- A61B 2018/00196: {reciprocating lengthwise}
- A61B 2018/00363: {Epicardium}
- A61B 2018/00375: {Ostium, e.g. ostium of pulmonary vein or artery}
- A61B 2018/00577: {Ablation}
- A61B 2018/00613: {Irreversible electroporation}
- A61B 2018/00791: {Temperature}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/1226: {powered by a battery}
- A61B 2018/124: {switching the output to different electrodes, e.g. sequentially}
- A61B 2018/1253: {monopolar}
- A61B 2018/126: {bipolar}
- A61B 2018/1407: {Loop}
- A61B 2018/1435: {Spiral}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2018/1497: {Electrodes covering only part of the probe circumference}
- A61B 2218/002: Irrigation
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The invention relates to an ablation catheter for treatment of a patient's tissue, for example for a PVI procedure on a patient's heart, comprising an elongated catheter shaft and an ablation portion being arranged at a distal end of the catheter shaft with a plurality of electrodes accommodated along the ablation portion, wherein the ablation portion comprises at least two loop sections forming a three-dimensional spiral. In order to increase safety of ablation treatment, spare adjacent tissue (e.g. nerves, vessels, esophagus) and shorten ablation time, a pitch, or clearance of two neighboring loop sections is greater than an ionization threshold of the medium around the distal section, for example blood or gases resulted from electrolysis. The invention further relates to an operation method of such ablation catheter.

## Claims

### Claim 1

An ablation catheter for treatment of patient tissue by delivery of high-voltage pulses comprising:
a catheter shaft and an ablation portion being arranged at a distal end of the catheter shaft with a plurality of electrodes accommodated along the ablation portion,
wherein the ablation portion comprises at least two loop sections forming a three-dimensional spiral,
wherein a pitch and/or clearance of two neighboring loop sections is greater than an ionization threshold of a respective medium around the plurality of electrodes, the medium comprising blood or gases resulted from electrolysis.

### Claim 2 (depends on 1)

The catheter of claim 1, wherein the pitch and/or clearance of two neighboring loop sections is further less than a therapeutic threshold of the respective tissue.

### Claim 3 (depends on 1)

The catheter of claim 1, wherein the diameters of two neighboring loop sections increase into the direction of the distal end of ablation portion or the diameters of two neighboring loop sections decrease into the direction of the distal end of the ablation portion.

### Claim 4 (depends on 1)

The catheter of claim 1, wherein at least two of the plurality of electrodes of the ablation portion are adapted to deliver to tissue high voltage monopolar pulsed field ablating (PFA) energy or bipolar PFA energy or a combination of monopolar and bipolar PFA energy.

### Claim 5 (depends on 1)

The catheter of claim 1, wherein at least two of the electrodes are controlled by an electronic control unit, wherein the electronic control unit is adapted to connect at least two of the plurality of electrodes with a high-voltage pulse generator and to pair these at least two electrodes in a pre-defined manner.

### Claim 6 (depends on 1)

The catheter of claim 1, wherein the catheter shaft comprises at least two lumens separated by a material with a dielectric strength greater than a threshold required to withstand high-voltage pulses.

### Claim 7 (depends on 1)

The catheter of claim 1, wherein the first lumen of the at least two lumens is configured to retain at least two electrode leads which are connected with electrodes providing the same first polarity and wherein the second lumen of the at last two lumens different from the first lumen is configured to retain at least two electrode leads which are connected with electrodes providing the same second polarity different from the first polarity.

### Claim 8 (depends on 1)

The catheter of claim 1, wherein the ablation portion comprises an inner support structure and/or a center wire connected with the distal tip of the ablation portion.

### Claim 9 (depends on 1)

The catheter of claim 1, wherein the electrodes are distributed along the at least two loops in a way, that the angular separation between the most distal and the most proximal electrode is at least 2*360°, or at least 720°.

### Claim 10 (depends on 1)

The catheter of claim 1, wherein the catheter further comprises at least one irrigation lumen configured to apply an irrigation fluid at the treatment site via at least one individual irrigation opening at the ablation section, preferably multiple irrigation openings at the individual electrodes, in between the electrodes or proximal and/or distal to the most proximal and most distal electrode at the ablation section.

### Claim 11

A method to operate an ablation catheter for treatment of patient tissue as for a PVI procedure on a patient's heart, comprising an elongated catheter shaft and an ablation portion being arranged at a distal end of the catheter shaft with a plurality of electrodes accommodated along the ablation portion, wherein the ablation portion comprises at least two loop sections forming a three-dimensional spiral, wherein the plurality of electrodes is energized with high-voltage charge-balanced pulsed electric fields which are delivered in a monopolar arrangement or in a bipolar arrangement or in a combination of a monopolar arrangement and a bipolar arrangement.

### Claim 12 (depends on 11)

The method of claim 11, wherein two neighboring electrodes along a loop section or two neighboring electrodes of different loop sections are energized with said pulsed electric fields in a bipolar arrangement.

### Claim 13 (depends on 11)

The method of claim 11, wherein the voltage amplitude of pulses delivered to said catheter electrodes is greater than 1 kV, preferably greater than 2.5 kV, more preferably between 2.5 kV and 3.5 kV.

### Claim 14 (depends on 11)

The method of claim 11, wherein the pulse width is greater than 0.5 μs, preferably between 0.5 μsand 30 μs.

### Claim 15 (depends on 11)

The method of claim 11, wherein a sterile irrigation fluid is applied at the treatment site, whereby preferably distilled water or a physiological saline solution having a low salinity, preferably of no more than 0.1%, is used as irrigation fluid.

### Claim 16 (depends on 11)

The method of claim 11, wherein an impedance of the medium around said plurality of electrodes is measured using electrodes from the plurality of electrodes.

### Claim 17 (depends on 11)

The method of claim 11, wherein biopotentials are acquired from the surrounding tissue using at least two mapping electrodes located on the ablation portion or the plurality of electrodes for ablation used in a mapping mode.

### Claim 18 (depends on 11)

The method of claim 11, wherein impedance values are measured over a frequency range using said plurality of electrodes.
