# US 11,992,237 B2 · Steerable ablation catheter

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- Number: US 11,992,237 B2
- Document ID: US11992237B2
- Status: Granted
- Kind: B2
- Application number: 17/125,508
- Filed: 2020-12-17
- Published: 2021-06-24
- Granted: 2024-05-28
- Earliest claimed: 2019-12-19
- Assignees: AneuMed, Inc.
- Applicants: AneuMed, Inc.
- Inventors: Hira V Thapliyal
- Web page: https://patentgrep.com/patent/US11992237B2

## CPC

- A61B 17/2202: {the ultrasound transducer being inside patient's body at the distal end of the catheter}
- A61B 17/320068: {using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745)}
- A61B 90/361: {Image-producing devices, e.g. surgical cameras}
- A61N 1/0565: {Electrode heads}
- A61B 2017/00243: {cardiac}
- A61B 2017/00323: {Cables or rods}
- A61B 2017/00327: {with actuating members moving in opposite directions}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/22067: {Blocking; Occlusion (A61B2017/22054 takes precedence)}
- A61B 2017/320069: {for ablating tissue}
- A61B 2090/3614: {using optical fibre}
- A61B 2217/007: with irrigation system
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A system for ablating target tissue includes an elongate anchor shaft, a radially expandable member coupled to the elongate anchor shaft, and an elongate ablation shaft. The radially expandable member has an expanded configuration for engagement with the target tissue to facilitate anchoring. The elongate ablation shaft may be slidably disposed in the elongate anchor shaft, and the distal portion of the elongate ablation shaft is steerable. An energy source is coupled to the elongate ablation shaft and is configured to deliver energy to the target tissue and ablate the target tissue. Actuation of the elongate ablation shaft directs the energy to the target tissue to form a desired ablation path in the target tissue.

## Claims

### Claim 1

A system for ablating target tissue, the system comprising:
an elongate anchor shaft having a proximal portion a distal portion, and a lumen extending therebetween;
a radially expandable member coupled to the distal portion of the elongate anchor shaft, wherein the radially expandable member has a collapsed configuration for delivery and an expanded configuration for engagement with the target tissue, and wherein in the expanded configuration the radially expandable member is configured to contact the target tissue to provide anchoring thereof and to facilitate visualization of the target tissue;
an elongate ablation shaft having a proximal portion, a distal portion, and a lumen extending therebetween, wherein the elongate ablation shaft is slidably disposed in the lumen of the elongate anchor shaft, and
wherein the distal portion of the elongate ablation shaft is steerable; and
an energy source coupled to the distal portion of the elongate ablation shaft, the energy source configured to deliver energy to the target tissue and ablate the target tissue,
wherein the energy source comprises an ultrasound transducer configured to emit ultrasound energy therefrom,
wherein the ultrasound transducer is a disc with a center hole therethrough, the center hole configured to allow fluid flow therethrough for cooling of the disc, and
wherein actuation of the distal portion of the elongate ablation shaft directs the energy to the target tissue to form a desired ablation path in the target tissue.

### Claim 2 (depends on 1)

The system of claim 1, further comprising a plurality of pull wires disposed in the elongate ablation shaft and coupled to the distal portion of the elongate ablation shaft, wherein actuation of one or more of the plurality of pull wires steers the distal portion of the elongate ablation shaft.

### Claim 3 (depends on 2)

The system of claim 2, wherein the plurality of pull wires comprise four pull wires disposed substantially evenly around a circumference of the elongate ablation shaft.

### Claim 4 (depends on 2)

The system of claim 2, wherein the plurality of pull wires are disposed in one or more lumens disposed in a wall of the elongate ablation shaft.

### Claim 5 (depends on 2)

The system of claim 2, wherein at least one of the plurality of pull wires comprises a first free end, a second free end, and an intermediate portion therebetween, wherein the first free end is disposed adjacent a proximal end of the ablation shaft, the intermediate portion extends along the ablation shaft, across a distal portion of the ablation shaft, and returns along the ablation shaft so that the second free end is disposed adjacent the proximal end of the ablation shaft.

### Claim 6 (depends on 1)

The system of claim 1, wherein the ultrasound energy is a low intensity collimated beam of ultrasound energy.

### Claim 7 (depends on 1)

The system of claim 1, wherein the ultrasound energy is emitted in a distal direction from the ultrasound transducer.

### Claim 8 (depends on 1)

The system of claim 1, further comprising a header element disposed between the ultrasound transducer and the distal portion of the elongate ablation shaft.

### Claim 9 (depends on 1)

The system of claim 1, wherein the energy source remains contact free with the target tissue during the ablation.

### Claim 10 (depends on 1)

The system of claim 1, wherein the target tissue comprises a pulmonary vein or tissue adjacent thereto.

### Claim 11 (depends on 1)

The system of claim 1, wherein actuation of the distal portion of the elongate ablation shaft in a substantially circular motion is configured to steer the distal portion of the elongate ablation shaft in a substantially circular motion to form a closed loop ablation path in the target tissue.

### Claim 12 (depends on 1)

The system of claim 1, wherein the ablation path comprises a transmural lesion in the target tissue.

### Claim 13 (depends on 1)

The system of claim 1, wherein the radially expandable member comprises a balloon.

### Claim 14 (depends on 1)

The system of claim 1, further comprising saline or another optically transparent fluid disposed in the radially expandable member, the saline or another fluid configured to radially expand the radially expandable member.

### Claim 15 (depends on 1)

The system of claim 1, wherein the radially expandable member comprises a nipple on a distal end thereof, the nipple configured to be disposed in a lumen of a blood vessel, and wherein the nipple allows fluid to bleed out of the expandable member.

### Claim 16 (depends on 1)

The system of claim 1, further comprising an imaging device disposed at least partially in the radially expandable member, wherein the imaging device is configured to provide an image of the ablation path.

### Claim 17 (depends on 16)

The system of claim 16, wherein the imaging device comprises a fiber optic imaging device.

### Claim 18 (depends on 16)

The system of claim 16, wherein the imaging device is slidably disposed in the elongate ablation shaft lumen.

### Claim 19 (depends on 1)

The system of claim 1, the system further comprising a pacing lead extending distally of the radially expandable member, the pacing lead configured to engage tissue and electrically stimulate the tissue.

### Claim 20 (depends on 19)

The system of claim 19, wherein the pacing lead passes through the radially expandable member and the elongate ablation shaft.

### Claim 21 (depends on 19)

The system of claim 19, wherein the pacing lead comprises a radially expandable loop on a distal end thereof, the radially expandable loop configured to engage the tissue.

### Claim 22

A system for ablating target tissue, the system comprising:
an elongate anchor shaft having a proximal portion a distal portion, and a lumen extending therebetween;
a radially expandable member coupled to the distal portion of the elongate anchor shaft, wherein the radially expandable member has a collapsed configuration for delivery and an expanded configuration for engagement with the target tissue, and wherein in the expanded configuration the radially expandable member is configured to contact the target tissue to provide anchoring thereof and to facilitate visualization of the target tissue;
an elongate ablation shaft having a proximal portion, a distal portion, and a lumen extending therebetween, wherein the elongate ablation shaft is slidably disposed in the lumen of the elongate anchor shaft, and
wherein the distal portion of the elongate ablation shaft is steerable;
an energy source coupled to the distal portion of the elongate ablation shaft, the energy source configured to deliver energy to the target tissue and ablate the target tissue, wherein the energy source comprises an ultrasound transducer configured to emit ultrasound energy therefrom, and
wherein actuation of the distal portion of the elongate ablation shaft directs the energy to the target tissue to form a desired ablation path in the target tissue; and
a header element disposed between the ultrasound transducer and the distal portion of the elongate ablation shaft.

### Claim 23

A system for ablating target tissue, the system comprising:
an elongate anchor shaft having a proximal portion a distal portion, and a lumen extending therebetween;
a radially expandable member coupled to the distal portion of the elongate anchor shaft, wherein the radially expandable member has a collapsed configuration for delivery and an expanded configuration for engagement with the target tissue, and wherein in the expanded configuration the radially expandable member is configured to contact the target tissue to provide anchoring thereof and to facilitate visualization of the target tissue;
an elongate ablation shaft having a proximal portion, a distal portion, and a lumen extending therebetween, wherein the elongate ablation shaft is slidably disposed in the lumen of the elongate anchor shaft, and
wherein the distal portion of the elongate ablation shaft is steerable;
an energy source coupled to the distal portion of the elongate ablation shaft, the energy source configured to deliver energy to the target tissue and ablate the target tissue, and
wherein actuation of the distal portion of the elongate ablation shaft directs the energy to the target tissue to form a desired ablation path in the target tissue; and
a plurality of pull wires disposed in the elongate ablation shaft and coupled to the distal portion of the elongate ablation shaft, wherein actuation of one or more of the plurality of pull wires steers the distal portion of the elongate ablation shaft,
wherein at least one of the plurality of pull wires comprises a first free end, a second free end, and an intermediate portion therebetween, wherein the first free is disposed adjacent a proximal end of the ablation shaft, the intermediate portion extends along the ablation shaft, across a distal portion of the ablation shaft, and returns along the ablation shaft so that the second free end is disposed adjacent the proximal end of the ablation shaft.
