# US 2024/0173071 A1 · Flexible Distal-End Assembly with Double-Sided Electrode Array and Irrigation

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- Number: US 2024/0173071 A1
- Document ID: US20240173071A1
- Status: Published application
- Kind: A1
- Application number: 18/434,355
- Filed: 2024-02-06
- Published: 2024-05-30
- Earliest claimed: 2020-04-17
- Assignees: Biosense Webster (Israel) Ltd.
- Applicants: Biosense Webster (Israel) Ltd.
- Inventors: Assaf GOVARI; Christopher Thomas BEECKLER; Andres Claudio ALTMANN
- Web page: https://patentgrep.com/patent/US20240173071A1

## CPC

- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 5/367: Electrophysiological study [EPS], e.g. electrical activation mapping or electro-anatomical mapping
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/00867: {shape memory effect}
- A61B 2018/00023: {closed, i.e. without wound contact by the fluid}
- A61B 2018/00029: {open}
- 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 2018/00351: {Heart}
- A61B 2018/00577: {Ablation}
- A61B 2018/00613: {Irreversible electroporation}
- 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 2562/046: in a matrix array
- A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier
- H05K 3/00: Apparatus or processes for manufacturing printed circuits
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- H05K: PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS

## Abstract

A medical probe includes a shaft and an expandable flexible distal-end assembly. The shaft is configured for insertion into a cavity of organ of a patient. The expandable flexible distal-end assembly, which is fitted at a distal-end of the shaft, includes a flat flexible backing sheet, including irrigation channels, and two flexible substrates having respective arrays of electrodes disposed thereon, the substrates attached one on either side of the backing sheet.

## Claims

### Claim 1

A manufacturing method of a medical probe, the method comprising:
preparing a flat flexible backing sheet, comprising irrigation channels;
fabricating two flexible substrates having respective arrays of electrodes disposed thereon;
attaching the two flexible substrates to the flat flexible backing sheet with one on either side to form an expandable flexible distal-end assembly; and
fitting the expandable flexible distal-end assembly at a distal-end of a shaft for insertion into a cavity of organ of a patient.

### Claim 2 (depends on 1)

The manufacturing method according to claim 1, wherein fitting the expandable flexible distal-end assembly comprises connecting the irrigation channels to a tube running in the shaft.

### Claim 3 (depends on 1)

The manufacturing method according to claim 1, wherein fabricating the two flexible substrates comprises forming openings in the two flexible substrates for flowing coolant from the irrigation channels into surrounding blood.

### Claim 4 (depends on 1)

The manufacturing method according to claim 1, wherein preparing the flat flexible backing sheet comprises preparing irrigation channels capable of flowing a coolant in a closed loop.

### Claim 5 (depends on 1)

The manufacturing method according to claim 1, wherein fabricating the two flexible substrates comprises fabricating printed circuit boards (PCBs).

### Claim 6 (depends on 1)

The manufacturing method according to claim 1, wherein at least one of the disposed electrodes is configured to be interchangeably used as an ablation electrode or as a sensing electrode.

### Claim 7 (depends on 1)

The manufacturing method according to claim 1, wherein the flat flexible backing sheet comprises nitinol.

### Claim 8

A medical probe, comprising:
a shaft for insertion into a cavity of an organ of a patient; and
an expandable flexible distal-end assembly, which is fitted at a distal-end of the shaft and comprises:
a flat flexible backing sheet, comprising an irrigation channel extending at least partially through the flat flexible backing sheet; and
a flexible substrate disposed on a first side of the flat flexible backing sheet and comprising:
an electrode disposed thereon; and
a fluid passage extending therethrough perpendicular to the irrigation channel.

### Claim 9 (depends on 8)

The medical probe of claim 8, the fluid passage configured to deliver fluid near the electrode.

### Claim 10 (depends on 8)

The medical probe of claim 8, the electrode comprising a plurality of electrodes disposed along the flexible substrate.

### Claim 11 (depends on 8)

The medical probe of claim 8, the electrode configured to deliver ablative energy to tissue.

### Claim 12 (depends on 8)

The medical probe of claim 8, the electrode configured for detecting electrophysiological signals.

### Claim 13 (depends on 8)

The medical probe of claim 8, the flexible substrate comprising a first flexible substrate, the electrode comprising a first electrode, and the fluid passage comprising a first fluid passage, the expandable flexible distal-end assembly further comprising:
a second flexible substrate disposed on a second side of the flat flexible backing sheet, the second flexible substrate comprising:
a second electrode disposed thereon; and
a second fluid passage extending therethrough perpendicular to the irrigation channel.

### Claim 14 (depends on 13)

The medical probe of claim 13, the first fluid passage and the second fluid passage together extending from a first opening defined by the first flexible substrate on the first side of the expandable flexible distal-end assembly, through the irrigation channel, and to a second opening defined by the second flexible substrate on the second side of the expandable flexible distal-end assembly opposite the first side.

### Claim 15 (depends on 14)

The medical probe of claim 14, wherein the first electrode and the second electrode are each configured to deliver ablative energy to tissue.

### Claim 16 (depends on 14)

The medical probe of claim 14, wherein the first electrode and the second electrode are each configured for detecting electrophysiological signals.

### Claim 17 (depends on 16)

The medical probe of claim 16, wherein when one of the first electrode or the second electrode is in contact with tissue, the other of the first electrode or the second electrode is configured to detect far field signals propagating through blood.

### Claim 18 (depends on 13)

The medical probe of claim 13, wherein the first flexible substrate and the second flexible substrate are printed circuit boards (PCBs).

### Claim 19 (depends on 8)

The medical probe according to claim 8, wherein the flat flexible backing sheet comprises nitinol.

### Claim 20 (depends on 8)

The medical probe according to claim 8, wherein the electrode is configured to be interchangeably used as an ablation electrode or as a sensing electrode.