# US 2024/0197399 A1 · Apparatus and method for nerve ablation in the wall of the gastointestinal tract

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- Number: US 2024/0197399 A1
- Document ID: US20240197399A1
- Status: Published application
- Kind: A1
- Application number: 18/595,037
- Filed: 2024-03-04
- Published: 2024-06-20
- Earliest claimed: 2016-08-14
- Assignees: Digma Medical Ltd.
- Applicants: Digma Medical Ltd.
- Inventors: Ilan BEN OREN
- Web page: https://patentgrep.com/patent/US20240197399A1

## CPC

- A61B 18/24: with a catheter (A61B18/26, A61B18/28 take precedence)
- A61B 5/0086: {using infrared radiation}
- A61B 5/4255: {Intestines, colon or appendix}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/6853: {with a balloon}
- A61B 6/00: Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment (instruments measuring radiation intensity for application in the field of nuclear medicine, e.g. in vivo counting, G01T1/161)
- A61B 18/14: Probes or electrodes therefor
- A61B 18/20: using laser
- A61B 18/22: the beam being directed along or through a flexible conduit, e.g. an optical fibre; {Couplings or} hand-pieces therefor
- A61B 2017/00057: {Light}
- A61B 2017/00128: {related to intensity or progress of surgical action}
- A61B 2018/0022: {Balloons}
- A61B 2018/00494: {Stomach, intestines or bowel}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00785: {Reflected power}
- A61B 2018/00904: {Automatic detection of target tissue}
- A61B 2562/0233: Special features of optical sensors or probes classified in A61B5/00
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Catheter for real-time evaluation of duodenal ablation, the catheter including an expandable member configured to stretch the duodenal wall and to generate a fixed distance between a center of the catheter and the duodenal wall; a laser transmitting element coupled with the catheter body and configured to transmit a first laser beam and a second laser beam; wherein the first laser beam is configured to cause ablative damage in a region of the duodenal wall as a result of its impingement thereon, and wherein the second laser beam is configured to detect modifications in the region of the duodenal wall resulting from the impingement of the first laser beam thereon.

## Claims

### Claim 1

An ablation device comprising:
a catheter comprising
an expandable member configured to stretch a wall of a gastro-intestinal (GI) lumen and to generate a fixed distance between a center of the catheter and the wall;
a laser transmitting element configured to couple to the catheter and to transmit a first laser beam and a second laser beam; wherein the first laser beam has a first infrared wavelength and a first spot diameter and is configured to cause ablative damage in a region of the wall as a result of its impingement thereon; and wherein the second laser beam has a second blue-red wavelength and a second spot diameter, and is configured to be transmitted to a second region of the wall to enable detection of modifications in the region of the wall resulting from the impingement of the first laser beam thereon; and
a rotatable deflective optical element functionally coupled with a laser emitting element and configured to direct the first and/or second laser beam to a region on and/or beneath the wall;
wherein the first and second laser beams are configured to be transmitted towards and/or cause ablative damage to different regions of the wall.

### Claim 2 (depends on 1)

The device of claim 1, wherein the laser emitting element comprises a first optical fiber configured to transmit the first laser beam and a second optical fiber configured to transmit the second laser beam, wherein the first and second fibers are spatially off-set.

### Claim 3 (depends on 2)

The device of claim 2, wherein said second laser beam impinges on a given region of the wall at a delay relative to the impingement of the first laser beam, when the deflective element is rotated.

### Claim 4 (depends on 1)

The device of claim 1, wherein the laser transmitting element further comprises a lens configured to deflect the first laser beam.

### Claim 5 (depends on 1)

The device of claim 1, wherein said laser emitting element comprises a double cladded fiber, wherein the first laser beam is delivered through a core of the double cladded fiber and wherein the second beam is delivered through the clad of the double cladded fiber.

### Claim 6 (depends on 1)

The device of claim 1, wherein the laser transmitting element further comprises a dispersive element configured to selectively refract the first and/or second laser beam.

### Claim 7 (depends on 1)

The device of claim 1, wherein the first wavelength is 1550 nm, 1567 nm, or 980 nm.

### Claim 8 (depends on 1)

The device of claim 1, wherein the second wavelength is a blue-green wavelength.

### Claim 9 (depends on 1)

The device of claim 1, wherein the second wavelength is 532 nm.

### Claim 10 (depends on 1)

The device of claim 1, wherein the second spot diameter is larger than the first spot diameter.

### Claim 11 (depends on 1)

The device of claim 1, wherein the second laser beam is transmitted through a multimode fiber.

### Claim 12

An ablation method comprising:
inserting a catheter into a GI lumen of a subject;
deploying an expandable member delivered by the catheter, thereby stretching a wall of the GI lumen and generating a fixed distance between a center of the catheter and the wall;
transmitting a first laser beam in a direction essentially perpendicular to a longitudinal axis of the catheter, towards the wall, wherein the first laser beam has a first infrared wavelength and a first spot diameter and for causing ablative damage in a region of the wall as a result of its impingement thereon;
transmitting a second laser beam essentially perpendicularly to the longitudinal axis of the catheter, wherein the second laser beam has a second blue-red wavelength and a second spot diameter and is enabled for detecting modifications in the region of the wall as a result of the impingement of the first laser beam thereon, and
wherein the first and second laser beams are transmitted towards different regions of the wall and wherein the first and/or second laser beam are directed using a rotatable deflective optical element.

### Claim 13 (depends on 12)

The method of claim 12, wherein the second laser beam has a second spot diameter larger than the first spot diameter.

### Claim 14 (depends on 12)

The method of claim 12, wherein the first wavelength is in the range of 1450-1600 nm.

### Claim 15 (depends on 12)

The method of claim 12, wherein the first wavelength is 1550 nm, 1567 nm, or 980 nm.

### Claim 16 (depends on 12)

The method of claim 12, wherein the second wavelength has a blue-green wavelength.

### Claim 17 (depends on 12)

The method of claim 12, wherein the second wavelength is 532 nm.

### Claim 18 (depends on 12)

The method of claim 12, wherein the second laser beam is transmitted at a delay relative to the transmission of the first laser beam.

### Claim 19 (depends on 12)

The method of claim 12, wherein the first and second laser beams are transmitted simultaneously towards the different regions of the wall.
