# US 10,864,031 B2 · Ablation method for creating elongate continuous lesions enclosing multiple vessel entries

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- Number: US 10,864,031 B2
- Document ID: US10864031B2
- Status: Granted
- Kind: B2
- Application number: 15/362,670
- Filed: 2016-11-28
- Published: 2017-06-01
- Granted: 2020-12-15
- Earliest claimed: 2015-11-30
- Assignees: Adagio Medical, Inc.
- Applicants: Adagio Medical, Inc.
- Inventors: Meital Mazor; James L. Cox; Alexei Babkin; Steven W. Kovalcheck; Thomas Chien; Nicolei King
- Web page: https://patentgrep.com/patent/US10864031B2

## CPC

- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 2018/00023: {closed, i.e. without wound contact by the fluid}
- A61B 2018/00029: {open}
- A61B 2018/00041: {Heating, e.g. defrosting}
- A61B 2018/00285: {Balloons}
- 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 2018/00821: {measured by a thermocouple}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00863: {Fluid flow}
- A61B 2018/00904: {Automatic detection of target tissue}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/0268: {with restriction of flow}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A method of creating a lesion in cardiac tissue where the method includes deploying a distal treatment section of an ablation catheter into a heart chamber and manipulating the distal treatment section against the cardiac tissue and into a curved shape that encloses a plurality of vessel entries in the heart chamber. The method further includes commencing a first application of ablation energy from the distal treatment section to the cardiac tissue and halting the first application of ablation energy to the cardiac tissue. The first application of ablation energy causes formation of a first continuous lesion in the cardiac tissue that encloses the plurality of vessel entries.

## Claims

### Claim 1

A method of creating a lesion in cardiac tissue, the method comprising:
deploying a distal treatment section of an ablation catheter into a heart chamber having a first side and a second side opposite the first side;
manipulating the distal treatment section against cardiac tissue and into a curved shape that simultaneously encloses a plurality of vessel entries on the first side of the heart chamber and excludes vessel entries on the second side of the heart chamber, and wherein the plurality of vessel entries on the first side of the heart chamber comprise a superior vessel entry and an inferior vessel entry;
commencing a first application of ablation energy from the distal treatment section to the cardiac tissue;
halting the first application of ablation energy to the cardiac tissue, wherein the first application of ablation energy causes formation of a first continuous lesion in the cardiac tissue that encloses the plurality of vessel entries, wherein the first continuous lesion enclosing the plurality of vessel entries encloses a superior and an inferior pulmonary vein entry on a first side of a left atrium;
manipulating the distal treatment section to a second side of the left atrium and into contact with cardiac tissue;
applying a second application of ablation energy from the distal treatment section such that a second continuous lesion is formed enclosing the superior and inferior pulmonary vein entries on the second side of the left atrium.

### Claim 2 (depends on 1)

The method of claim 1, further comprising manipulating the distal treatment section into contact with a posterior wall of the left atrium, and applying a third application of ablation energy from the distal treatment section such that a third continuous lesion is formed, the third continuous lesion overlapping with the first continuous lesion and the second continuous lesion, and extending from a roof to a floor of the posterior wall.

### Claim 3 (depends on 2)

The method of claim 2, wherein the first, second, and third continuous lesions collectively form a box-like shaped lesion surrounding the superior and inferior left and right pulmonary vein entries of the left atrium.

### Claim 4 (depends on 1)

The method of claim 1, further comprising detecting the position of the distal treatment section of the ablation catheter in the heart chamber, wherein the detecting is performed using electrodes present on the distal treatment section of the ablation catheter.

### Claim 5 (depends on 1)

The method of claim 1, wherein the distal treatment section is deformable to a circular shape, causing the shape of lesions to be a closed circular shape.

### Claim 6 (depends on 1)

The method of claim 1, wherein the first application of energy is application of cryoenergy.

### Claim 7 (depends on 6)

The method of claim 6, wherein the application of cryoenergy comprises circulating a near critical fluid through at least one fluid delivery tube and at least one fluid return tube extending through the distal treatment section of the ablation catheter.

### Claim 8

A method of performing an ablation procedure in a heart cavity, the method comprising the steps of:
advancing an ablation catheter into the heart cavity;
navigating a treatment section of the ablation catheter to a first area of interest in the heart cavity;
manipulating the treatment section to form a loop-like shape to encircle cardiac tissue in the first area of interest in the heart cavity and to contact the cardiac tissue in the first area of interest in the heart cavity, wherein the first area of interest comprises an inferior and superior vessel entries and the loop-like shape encircles both vessel entries at the same time;
performing at least one ablation cycle from the treatment section to create a first continuous lesion that encircles the cardiac tissue in the first area of interest in the heart cavity;
navigating the treatment section of the ablation catheter to a second area of interest in the heart cavity;
manipulating the treatment section to encircle and contact cardiac tissue in the second area of interest in the heart cavity; and
performing at least one ablation cycle from the treatment section to create a second continuous lesion that encircles the cardiac tissue in the second area of interest in the heart cavity.

### Claim 9 (depends on 8)

The method of claim 8, further comprising the steps of:
navigating the treatment section of the ablation catheter to a third area of interest in the heart cavity;
manipulating the treatment section to encircle and contact cardiac tissue in the third area of interest in the heart cavity; and
performing at least one ablation cycle from the treatment section to create a third continuous lesion that encircles the cardiac tissue in the third area of interest in the heart cavity.

### Claim 10 (depends on 9)

The method of claim 9, further comprising the steps of:
navigating the treatment section of the ablation catheter to a fourth area of interest in the heart cavity;
manipulating the treatment section to encircle and contact cardiac tissue in the fourth area of interest in the heart cavity; and
performing at least one ablation cycle from the treatment section to create a fourth continuous lesion that encircles the cardiac tissue in the fourth area of interest in the heart cavity.

### Claim 11 (depends on 8)

The method of claim 8, further comprising the step of verifying cardiac tissue contact prior to performing at least one ablation cycle from the treatment section.

### Claim 12 (depends on 8)

The method of claim 8, further comprising the step of confirming that the at least one ablation cycle created the first continuous lesion.

### Claim 13 (depends on 12)

The method of claim 12, further comprising the step of performing at least one ablation cycle from the treatment section.

### Claim 14 (depends on 8)

The method of claim 8, wherein the at least one ablation cycle comprises application of cryoenergy.

### Claim 15 (depends on 14)

The method of claim 14, wherein the application of cryoenergy comprises circulating a near critical fluid through at least one fluid delivery tube and at least one fluid return tube extending through the treatment section of the ablation catheter.

### Claim 16

A method of performing an ablation procedure in a heart, the method comprising the steps of:
advancing an ablation catheter into a left atrium;
navigating a treatment section of the ablation catheter to a first side of the left atrium to an antrum of a first side of superior pulmonary vein entry and a first side of inferior pulmonary vein entry;
manipulating the treatment section to form a loop-like shape to simultaneously encircle the first side superior pulmonary vein entry and the first side inferior pulmonary vein entry and to contact cardiac tissue surrounding the first side superior pulmonary vein entry and the first side inferior pulmonary vein entry;
performing at least one ablation cycle from the treatment section to create a first continuous lesion that encircles the first side superior pulmonary vein entry and the first side inferior pulmonary vein entry;
navigating the treatment section of the ablation catheter to a second side of the left atrium to an antrum of a second side of superior pulmonary vein entry and a second side of inferior pulmonary vein entry;
manipulating the treatment section to encircle the second side superior pulmonary vein entry and the second side inferior pulmonary vein entry and to contact cardiac tissue surrounding the second side superior pulmonary vein entry and the second side inferior pulmonary vein entry;
performing at least one ablation cycle from the treatment section to create a second continuous lesion that encircles the second side superior pulmonary vein entry and the second side inferior pulmonary vein entry;
navigating the treatment section of the ablation catheter to a posterior wall of the left atrium;
manipulating the treatment section to form a loop that overlaps the first continuous lesion and the second continuous lesion and that contacts cardiac tissue at the posterior wall; and
performing at least one ablation cycle from the treatment section to create a third continuous lesion that overlaps the first continuous lesion and the second continuous lesion, wherein the first continuous lesion, the second continuous lesion and the third continuous lesion form a composite continuous lesion that encircles the first side superior pulmonary vein entry, the first side inferior pulmonary vein entry, the second side superior pulmonary vein entry and the second side inferior pulmonary vein entry.

### Claim 17 (depends on 16)

The method of claim 16, further comprising the step of creating a lesion from the treatment section that extends from an area adjacent to a mitral valve annulus and intersects at least a portion of the composite continuous lesion.

### Claim 18 (depends on 16)

The method of claim 16, further comprising the step of creating a lesion from the treatment section that extends from an area adjacent to a mitral valve annulus and intersects at least a portion of the first continuous lesion or the second continuous lesion or the third continuous lesion.

### Claim 19 (depends on 16)

The method of claim 16, further comprising the steps of:
navigating the treatment section of the ablation catheter to a right atrium; and
creating a lesion from the treatment section that connects an entrance of an Inferior Vena Cava and an annulus of the Tricuspid Valve and extends through a Cava Tricuspid Isthmus.

### Claim 20 (depends on 16)

The method of claim 16, further comprising the steps of:
creating a lesion from the treatment section that extends from an area adjacent to a mitral valve annulus and intersects at least a portion of the composite continuous lesion;
navigating the treatment section of the ablation catheter to a right atrium; and
creating a lesion from the treatment section that connects an entrance of an Inferior Vena Cava and an annulus of the Tricuspid Valve and extends through a Cava Tricuspid Isthmus.

### Claim 21 (depends on 16)

The method of claim 16, wherein the at least one ablation cycle comprises application of cryoenergy.

### Claim 22 (depends on 21)

The method of claim 21, wherein the application of cryoenergy comprises circulating a near critical fluid through at least one fluid delivery tube and at least one fluid return tube extending through the treatment section of the ablation catheter.
