# US 11,896,395 B2 · Catheter with insert-molded microelectrode

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- Number: US 11,896,395 B2
- Document ID: US11896395B2
- Status: Granted
- Kind: B2
- Application number: 16/994,745
- Filed: 2020-08-17
- Published: 2021-03-18
- Granted: 2024-02-13
- Earliest claimed: 2019-09-17
- Assignees: Biosense Webster (Israel) Ltd.
- Applicants: Biosense Webster (Israel) Ltd.
- Inventors: Anand R. Rao; Keshava Datta; Thanh V. Nguyen; Thomas V. Selkee
- Web page: https://patentgrep.com/patent/US11896395B2

## CPC

- A61B 5/6852: {Catheters}
- 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 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 5/367: Electrophysiological study [EPS], e.g. electrical activation mapping or electro-anatomical mapping
- A61B 2017/00199: {with a console, e.g. a control panel with a display}
- A61B 2017/00327: {with actuating members moving in opposite directions}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2018/00077: {high, i.e. electrically conducting}
- A61B 2018/00083: {low, i.e. electrically insulating}
- A61B 2018/00351: {Heart}
- A61B 2018/00577: {Ablation}
- A61B 2018/00613: {Irreversible electroporation}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2034/2048: {using an accelerometer or inertia sensor}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2055: {Optical tracking systems}
- A61B 2034/2063: {Acoustic tracking systems, e.g. using ultrasound}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2217/007: with irrigation system
- A61B 2218/002: Irrigation
- A61B 2562/0209: Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
- A61B 2562/0261: Strain gauges
- A61B 2562/028: Microscale sensors, e.g. electromechanical sensors [MEMS]
- A61B 2562/125: characterised by the manufacture of electrodes
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An apparatus includes a catheter assembly for use in a medical procedure to conduct electrophysiological mapping. The catheter assembly includes a catheter having an end effector with a tip member. One or more insert-molded microelectrodes are located in the tip member of the end effector for conducting electrophysiological mapping. The insert-molded microelectrodes include a microelectrode and a composite that isolates the microelectrode from contact with the tip member.

## Claims

### Claim 1

An apparatus for use in a medical procedure to conduct electrophysiological mapping, the apparatus comprising:
(a) a body; and
(b) an end effector connected with a distal end of the body, the end effector including:
(i) a tip member at the distal end of an end effector, the tip member having a first longitudinal axis and a shell that defines an outer surface of the tip member, the tip member further having an elongated bore located in the outer surface of the shell and parallel with the first longitudinal axis, and
(ii) an insert positionable within the elongated bore of the tip member, the insert including a microelectrode and a non-conductive molded composite configured to act as a contact barrier between the microelectrode and the shell, the insert shaped to conform to a contour of the outer surface of the shell,
(1) the microelectrode including:
(A) a microelectrode distal surface,
(B) a microelectrode distal portion comprising a first outer circumference, and
(C) an elongated microelectrode proximal portion comprising a second outer circumference, wherein the second outer circumference is smaller than the first outer circumference,
(2) the non-conductive molded composite including:
(A) a composite distal portion circumferentially surrounding the microelectrode distal portion,
(B) a composite distal surface surrounding the microelectrode distal surface,
(C) an elongated composite proximal portion surrounding the elongated microelectrode proximal portion, and
(D) a flange formed by an inner surface of the composite distal portion and the elongated composite proximal portion, the microelectrode distal portion being seated in the flange.

### Claim 2 (depends on 1)

The apparatus of claim 1, the elongated bore of the tip member extending longitudinally in a proximal direction toward the body.

### Claim 3 (depends on 1)

The apparatus of claim 1, the insert further including an engaging feature configured in the elongated composite proximal portion configured to engage with an interior wall of the elongated bore.

### Claim 4 (depends on 3)

The apparatus of claim 3, the engaging feature being resilient and making a snap-fit connection with the elongated bore.

### Claim 5 (depends on 3)

The apparatus of claim 3, the engaging feature being configured to engage with the elongated bore to make a permanent connection between the insert and the shell.

### Claim 6 (depends on 1)

The apparatus of claim 1, the insert being configured to connect with the shell without the use of adhesive.

### Claim 7 (depends on 1)

The apparatus of claim 1, the tip member having a plurality of openings configured to deliver an irrigation fluid.

### Claim 8 (depends on 1)

The apparatus of claim 1, the tip member being configured to deliver electrical energy to a target site.

### Claim 9 (depends on 1)

The apparatus of claim 1, the body defining a second longitudinal axis, with the end effector being configured to deflect away from the second longitudinal axis.

### Claim 10 (depends on 1)

The apparatus of claim 1, the outer surface of the shell including a curved region that extends circumferentially around the tip member, the elongated bore being positioned in the curved region, and the insert being positionable in the elongated bore within the curved region.

### Claim 11 (depends on 1)

The apparatus of claim 1, the apparatus having multiple elongated bores in the outer surface of the shell with multiple inserts, each of the multiple elongated bores being configured to receive one of the inserts.

### Claim 12 (depends on 1)

The apparatus of claim 1, the microelectrode distal surface protrudes distally from the non-conductive molded composite distal surface.

### Claim 13 (depends on 12)

The apparatus of claim 12, the microelectrode distal surface being curved and extending parallel with the contour of the outer surface of the shell.

### Claim 14 (depends on 12)

The apparatus of claim 12, the non-conductive molded composite distal surface being curved and extending parallel with the contour of outer surface of the shell.

### Claim 15 (depends on 12)

The apparatus of claim 12, the non-conductive molded composite distal surface being recessed relative to the outer surface of the shell.

### Claim 16 (depends on 12)

The apparatus of claim 12, the microelectrode distal surface of the microelectrode extending flush with the outer surface of the shell.

### Claim 17 (depends on 1)

The apparatus of claim 1, the microelectrode of the insert extending further proximally relative to the non-conductive molded composite of the insert.