# US 9,872,717 B2 · Balloon catheter with flexible electrode assemblies

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- Number: US 9,872,717 B2
- Document ID: US9872717B2
- Status: Granted
- Kind: B2
- Application number: 14/747,702
- Filed: 2015-06-23
- Published: 2015-10-08
- Granted: 2018-01-23
- Earliest claimed: 2008-05-27
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Robert F. Bencini; Frank Ingle; Josef V. Koblish; Rebecca Tin; James Mazzone; Byron Chun; David Lawrence
- Web page: https://patentgrep.com/patent/US9872717B2

## CPC

- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 2018/00017: {with gas}
- A61B 2018/00023: {closed, i.e. without wound contact by the fluid}
- A61B 2018/0022: {Balloons}
- A61B 2018/00714: {Temperature}
- A61B 2018/00791: {Temperature}
- A61B 2018/00797: {measured by multiple temperature sensors}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/0262: {using a circulating cryogenic fluid}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

In some implementations, a method of ablating body tissue includes (a) locating an inflatable balloon portion of a cryotherapy balloon catheter at a treatment site internal to a patient's body, and inflating the inflatable balloon portion; (b) employing electrodes that are disposed on an expandable surface of the inflatable balloon portion to electrically characterize body tissue at the treatment site; (c) ablating the body tissue by supplying a cryotherapy agent to the inflatable balloon portion to cool the body tissue to a therapeutic temperature; (d) employing the electrodes to determine whether the ablating caused desired electrical changes in the body tissue; and (e) repeating (c) and (d) when it is determined that the ablating did not cause the desired electrical changes.

## Claims

### Claim 1

A device, comprising:
a catheter having a distal end, a proximal end and a longitudinal axis extending therebetween;
a balloon coupled to the distal end of the catheter; and
a plurality of separate flexible electrode assemblies circumferentially spaced apart from each other and attached to an outer surface of the balloon, each electrode assembly comprising a flexible sheet, first and second conductor layers extending longitudinally along opposing first and second surfaces of the flexible sheet, and first and second insulator layers disposed over at least a portion of the first and second conductor layers, respectively;
wherein at least one of the flexible electrode assemblies includes a first electrode formed by an opening in the first insulator layer and a second electrode formed by an opening in the second insulator layer, wherein the first and second electrodes are spaced apart longitudinally from each other.

### Claim 2 (depends on 1)

The device of claim 1, wherein the first and second conductor layers include copper.

### Claim 3 (depends on 1)

The device of claim 1, wherein the first and second conductor layers include platinum.

### Claim 4 (depends on 1)

The device of claim 1, wherein the first and second conductor layers each include a layer of a first material coated with a layer of a second material different from the first material.

### Claim 5 (depends on 4)

The device of claim 4, wherein the first material is copper and the second material is platinum.

### Claim 6 (depends on 1)

The device of claim 1, further comprising a thermal sensor.

### Claim 7 (depends on 1)

The device of claim 1, further comprising a sheath that surrounds the catheter, through which the catheter is translated.

### Claim 8 (depends on 1)

The device of claim 1, wherein wires connected to the electrodes extend along the catheter in a braided pattern towards the proximal end.

### Claim 9

A device, comprising:
an elongate shaft having a distal end, a proximal end and a longitudinal axis extending therebetween;
a balloon coupled to the distal end of the elongate shaft; and
a plurality of separate flexible electrode assemblies circumferentially spaced apart from each other and attached to an outer surface of the balloon, each electrode assembly comprising a first insulator layer disposed on the balloon, a first conductor layer disposed on the first insulator layer, a flexible sheet disposed on the first conductor layer, a second conductor layer disposed on the flexible sheet, and a second insulator layer disposed on the second conductor layer;
wherein at least one of the flexible electrode assemblies includes a first electrode formed by an opening in the first insulator layer and a second electrode formed by an opening in the second insulator layer, wherein the first and second electrodes are spaced apart longitudinally from each other.

### Claim 10 (depends on 9)

The device of claim 9, wherein the first and second conductor layers include copper.

### Claim 11 (depends on 9)

The device of claim 9, wherein the first and second conductor layers include platinum.

### Claim 12 (depends on 9)

The device of claim 9, wherein the first and second conductor layers each include a layer of a first material coated with a layer of a second material different from the first material.

### Claim 13 (depends on 12)

The device of claim 12, wherein the first material is copper and the second material is platinum.

### Claim 14 (depends on 9)

The device of claim 9, further comprising a thermal sensor.

### Claim 15 (depends on 9)

The device of claim 9, further comprising a sheath that surrounds the elongate shaft, through which the elongate shaft is translated.

### Claim 16 (depends on 9)

The device of claim 9, wherein wires connected to the electrodes extend along the elongate shaft in a braided pattern towards the proximal end.