# US 12,108,983 B2 · Device, system and method to ablate cardiac tissue

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- Number: US 12,108,983 B2
- Document ID: US12108983B2
- Status: Granted
- Kind: B2
- Application number: 17/526,299
- Filed: 2021-11-15
- Published: 2022-05-19
- Granted: 2024-10-08
- Earliest claimed: 2019-05-03
- Assignees: Biosense Webster (Israel) Ltd.
- Applicants: Biosense Webster (Israel) Ltd.
- Inventors: Reecha Sharma; Robert B. Stagg; Zhong Wang; Betzi Zafra; Lee Ming Boo; Assaf Govari; Thomas V. Selkee; Christopher Thomas Beeckler; Andres Claudio Altmann; Joseph Thomas Keyes; Athanassios Papaioannou; Kristine B. Fuimaono
- Web page: https://patentgrep.com/patent/US12108983B2

## CPC

- A61B 18/1233: {with circuits for assuring patient safety}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 5/361: Detecting fibrillation
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 2018/00351: {Heart}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00375: {Ostium, e.g. ostium of pulmonary vein or artery}
- A61B 2018/00577: {Ablation}
- A61B 2018/00678: {upper}
- A61B 2018/00702: {Power or energy}
- A61B 2018/00714: {Temperature}
- A61B 2018/00755: {Resistance or impedance}
- A61B 2018/00761: {Duration}
- A61B 2018/00797: {measured by multiple temperature sensors}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2218/002: Irrigation
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method that includes selectively positioning an ablation catheter system at a treatment site; and ablating tissue at the treatment site with the ablation catheter system using a power setting of approximately 90W applied to tissue for approximately four (4) second increments with a break period of approximately 4 seconds between applications.

## Claims

### Claim 1

A method or use, comprising:
selectively positioning an ablation catheter system at a treatment site comprising cardiac tissue;
ablating cardiac tissue at the treatment site with the ablation catheter system using a power setting of approximately 90W applied to tissue for a first ablation time of approximately four (4) seconds to achieve a first maximum tissue temperature;
ceasing ablation for a break period of approximately 4 seconds immediately following the first ablation time;
ablating, immediately after the break period of approximately 4 seconds and using the power setting of approximately 90W applied to the cardiac tissue for a second ablation time of approximately 4 seconds, the cardiac tissue at the treatment site with the ablation catheter system to achieve a second maximum tissue temperature; and
achieving approximately zero incidence of steam pop occurrence in both left and right atrial ablations and complete pulmonary vein isolation, by the ablation catheter system, for all patients of a predetermined patient population suffering from PAF.

### Claim 2 (depends on 1)

The method or use of claim 1, wherein the second maximum tissue temperature is approximately 76° C.

### Claim 3 (depends on 1)

The method or use of claim 1, the step of ablating cardiac tissue further comprising increasing of temperature between first and second maximum tissue temperature by at least about 13% between first and second ablation applications.

### Claim 4 (depends on 1)

The method or use of claim 1, the step of ablating tissue comprises a point-by-point “kissing” ablation approach causing a continuous and transmural linear lesion line at an atrial wall with minimal over-lapped lesions.

### Claim 5 (depends on 1)

The method or use of claim 1, the step of ablating tissue comprising achieving a lesion depth approximately 40% deeper between first and second ablation applications, the method or use further comprising applying to the treatment site, by a distal end of the ablation catheter system, a contact force ranging between approximately 5-30 grams.

### Claim 6 (depends on 1)

The method or use of claim 1, further comprising:
delivering, by and through an elongated body of the ablation catheter system, a continuous infusion of approximately 8 milliliters/minute of treatment solution when not delivering radiofrequency energy during radiofrequency ablation.

### Claim 7 (depends on 1)

The method or use of claim 1, further comprising:
moving the ablation catheter system approximately 4 millimeter if clinically effective ablation is achieved within 20 seconds as determined by electrogram reduction and/or impedance drop.

### Claim 8

A method or use for an ablation procedure, comprising:
delivering an ablation catheter system to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor in proximity with the other;
ablating cardiac tissue with the ablation catheter system at a predetermined irrigation fluid rate and power setting comprising approximately 90W;
ceasing ablation for a break period of approximately 4 seconds immediately following the first ablation time;
ablating, immediately after the break period of approximately 4 seconds for a second ablation time of approximately 4 seconds; and
achieving approximately zero incidence of steam pop occurrence in both left and right atrial ablations and complete pulmonary vein isolation, by the ablation catheter system, for all patients of a predetermined patient population suffering from PAF.

### Claim 9 (depends on 8)

The method or use of claim 8, the ablation catheter system comprising:
an elongated body;
an electrode assembly comprising a shell configured with an inner chamber and a wall; and
a micro-element extending through the inner chamber between a proximal portion and a distal portion of the shell, the micro-element having a distal end received in at least one aperture in the wall, the distal end being at least coextensive with an outer surface of the wall.

### Claim 10 (depends on 8)

The method or use of claim 8, the step of achieving complete pulmonary vein isolation further comprises applying an average force of approximately 7.5 grams by the ablation catheter system to the cardiac tissue during use and achieving a target temperature of approximately 50° C. and ablation duration of approximately 4 seconds.

### Claim 11 (depends on 8)

The method or use of claim 8, the step of achieving complete pulmonary vein isolation further comprises applying an average force of approximately 9 grams by the ablation catheter system to the cardiac tissue during use and achieving a target temperature of approximately 55° C. and ablation duration of approximately 4 seconds.

### Claim 12 (depends on 8)

The method or use of claim 8, the step of achieving complete pulmonary vein isolation further comprises applying an average force of approximately 17.7 grams by the ablation catheter system to the cardiac tissue during use and achieving a target temperature of approximately 60° C. and ablation duration of approximately 4 seconds.

### Claim 13 (depends on 8)

The method or use of claim 8, the step of achieving complete pulmonary vein isolation further comprises applying an average force of approximately 13.6 grams by the ablation catheter system to the cardiac tissue during use and achieving a target temperature of approximately 60° C. and ablation duration of approximately 2 seconds.

### Claim 14 (depends on 8)

The method or use of claim 8, further comprising: delivering, by the ablation catheter system, the predetermined irrigation flow rate of approximately 380 mL or less of treatment fluids to the treatment site during the ablation procedure.

### Claim 15 (depends on 8)

The method or use of claim 8, the step of achieving complete pulmonary vein isolation further comprising a total ablation procedure time less than or equal to approximately 46 minutes.

### Claim 16 (depends on 8)

The method or use of claim 8, the step of achieving complete pulmonary vein isolation further comprising a total fluoroscopy time of less than or equal to approximately 6.5 minutes or less.

### Claim 17 (depends on 8)

The method or use of claim 8, the step of achieving complete pulmonary vein isolation further comprising a total radiofrequency application duration time of approximately 8 minutes or less.

### Claim 18 (depends on 8)

The method or use of claim 8, the step of achieving complete pulmonary vein isolation further comprising a total radiofrequency application duration time of 30 seconds on a posterior wall of the treatment site.

### Claim 19 (depends on 8)

The method or use of claim 8, the step of ablating the cardiac tissue comprises a point-by-point “kissing” ablation approach causing a continuous and transmural linear lesion line at an atrial wall with minimal over-lapped lesions.