# US 12,599,360 B2 · Ultrasonic imaging ablation catheter system and method

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- Number: US 12,599,360 B2
- Document ID: US12599360B2
- Status: Granted
- Kind: B2
- Application number: 18/049,214
- Filed: 2022-10-24
- Published: 2024-04-25
- Granted: 2026-04-14
- Earliest claimed: 2022-10-24
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Donald Masters; Jesus Andres Lopez
- Web page: https://patentgrep.com/patent/US12599360B2

## CPC

- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/4488: {the transducer being a phased array}
- A61B 8/0883: {for diagnosis of the heart}
- A61B 8/4483: {characterised by features of the ultrasound transducer}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 8/445: {Details of catheter construction}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An integrated ultrasonic imaging and ablation system is disclosed. The system comprising an ablation catheter having a longitudinal axis, a proximal end, and a distal end. A micro-electromechanical (MEMS) based Piezoelectric Micromachined Ultrasonic Transducer (pMUT) or other ultrasound transducer disposed within the distal end of the ablation catheter. A catheter shaft is connected at one end to a handle assembly and at other end to the MEMS based pMUT array. A first carrier assembly is coupled to the catheter shaft and having a first array of electrodes coupled to a plurality of first carrier arms. A second carrier assembly is coupled to the catheter shaft and having a second array of electrodes coupled to a plurality of second carrier arms.

## Claims

### Claim 1

An integrated ultrasonic imaging and ablation system comprising:
an ablation catheter having a longitudinal axis, a proximal end, and a distal end;
a micro-electromechanical (MEMS) based Piezoelectric Machined Ultrasonic Transducer (pMUT) array comprising a substrate and a plurality of pMUT array elements arranged on the substrate;
a catheter shaft connected at one end to a handle assembly and at other end to the MEMS based pMUT array;
a first carrier assembly coupled to the catheter shaft at a proximal end and having a first array of electrodes coupled to a plurality of first carrier arms;
a second carrier assembly coupled to the catheter shaft at a distal end and having a second array of electrodes coupled to a plurality of second carrier arms, a proximal end of the plurality of second carrier arms being pivotally attached to a distal end of the plurality of first carrier arms; and
a ring that couples a proximal end of the plurality of second carrier arms to the catheter shaft;
wherein the MEMS based pMUT array is mounted to the ring.

### Claim 2 (depends on 1)

The integrated ultrasonic imaging and ablation system of claim 1, wherein the ablation catheter comprises a steering control unit positioned within the handle assembly, for articulating a distal tip of the ablation catheter and aligning face of the MEMS based pMUT array towards internal views including an anterior position or a posterior position and right or left position of the tissue.

### Claim 3 (depends on 2)

The integrated ultrasonic imaging and ablation system of claim 2, wherein the distal tip of the ablation catheter is coated with a material to provide electrical isolation and transmission of ultrasound signals.

### Claim 4 (depends on 1)

The integrated ultrasonic imaging and ablation system of claim 1, wherein the ablation catheter is coupled to an imaging device using a dongle, and the dongle is configured to communicate ultrasound transmit pulses and ultrasound receive waveforms between the imaging device and the ablation catheter.

### Claim 5 (depends on 1)

The integrated ultrasonic imaging and ablation system of claim 1, wherein each of the plurality of pMUT array elements having transducer cells of multiple diameters, to achieve a wide bandwidth.

### Claim 6 (depends on 1)

The integrated ultrasonic imaging and ablation system of claim 1, wherein each of the plurality of pMUT array elements is a linear phased array.

### Claim 7 (depends on 1)

The integrated ultrasonic imaging and ablation system of claim 1, wherein each of the plurality of pMUT array elements is a circular array.

### Claim 8

An integrated ultrasound imaging and ablation system comprising:
an ablation catheter having a longitudinal axis, a proximal end, and a distal end;
a catheter shaft connected at one end to a handle assembly and at another end to a ring;
a first carrier assembly coupled to the catheter shaft and having a first radially expandable array of electrodes coupled to a plurality of first carrier arms; and
a second carrier assembly coupled to the catheter shaft and having a second radially expandable array of electrodes coupled to a plurality of second carrier arms, a proximal end of the second carrier arms being pivotally attached to a distal end of the plurality of first carrier arms via the ring;
a micro-electromechanical (MEMS) based Piezoelectric Micromachined Ultrasonic Transducer (pMUT) array, wherein the MEMS based pMUT array comprises a substrate and a plurality of MEMS based pMUT array elements arranged on the substrate;
wherein the MEMS based pMUT array is mounted to the ring; and
an electronic flex cable connected at one end to the handle assembly and at other end to the MEMS based pMUT array, wherein the electronic flex cable is in communication with at least one signal trace and advances distally inside of the ring, and is further configured to:
direct each of the plurality of MEMS based pMUT array elements, via the at least one signal trace, to transmit and receive, with respect to heart, ultrasound beams;
receive at least one signal from the plurality of MEMS based pMUT array elements based on transmitting and receiving at least one ultrasound beam of the ultrasound beams; and
construct at least one image of at least a portion of the heart based on the at least one signal.

### Claim 9 (depends on 8)

The integrated ultrasonic imaging and ablation system of claim 8, wherein the ultrasound beams having a bandwidth including a predetermined fundamental mode vibration of each of the plurality of pMUT array elements, such that a single array element transmits and receives multiple fundamental mode vibrations simultaneously.

### Claim 10

A medical device, comprising:
a catheter shaft comprising an outer shaft, a first control shaft slidingly received by the outer shaft, and a second control shaft slidingly received by the first control shaft;
a first carrier assembly coupled to the first control shaft and having a first radially expandable array of electrodes coupled to a plurality of first carrier arms; and
a second carrier assembly rotatably coupled to the second control shaft and having a second radially expandable array of electrodes coupled to a plurality of second carrier arms, the second carrier assembly rotatable about the first carrier assembly;
a ring disposed between the first carrier assembly and the second carrier assembly;
a micro-electromechanical (MEMS) based Piezoelectric Micromachined Ultrasonic Transducer (pMUT) array, wherein the MEMS based pMUT array comprises a substrate and a plurality of MEMS based pMUT array elements arranged on the substrate; and
an electronic flex cable connected at one end to a handle assembly and at other end to the MEMS based pMUT array, wherein a distal end of the electronic flex cable is connected at a radial location on the catheter shaft that is offset from where a proximal end of the electronic flex cable is connected on the catheter shaft; and
wherein the MEMS based pMUT array is mounted to the ring; and the electronic flex cable distally advances inside of the ring.

### Claim 11 (depends on 10)

The medical device of claim 10, wherein the first radially expandable array of electrodes having a series of longitudinally spaced electrodes.

### Claim 12 (depends on 10)

The medical device of claim 10, further comprising a mapping element coupled to the first carrier assembly.

### Claim 13 (depends on 12)

The medical device of claim 12, wherein the mapping element is distal to the first radially expandable array of electrodes.

### Claim 14 (depends on 10)

The medical device of claim 10, wherein the catheter shaft defines a guidewire lumen.

### Claim 15 (depends on 12)

The medical device of claim 12, wherein the offset from where the proximal end of the electronic flex cable is connected to the catheter shaft is about 90°.