# US 2019/0167349 A1 · Apparatus and method for nerve ablation in the wall of the gastointestinal tract

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- Number: US 2019/0167349 A1
- Document ID: US20190167349A1
- Status: Published application
- Kind: A1
- Application number: 16/323,741
- Filed: 2017-08-14
- Published: 2019-06-06
- Earliest claimed: 2016-08-14
- Assignees: Digma Medical Ltd.
- Applicants: Digma Medical Ltd.
- Inventors: Yonatan SHAMAY; Boaz BEHAR; Ilan BEN OREN
- Web page: https://patentgrep.com/patent/US20190167349A1

## 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 at position 1

-23. (canceled)

### Claim 24

A device for real-time evaluation of duodenal ablation, the device comprising a catheter comprising:
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 has a first wavelength and a first spot diameter and 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 has a second wavelength and a second spot diameter and is configured to detect modifications in the region of the duodenal wall resulting from the impingement of the first laser beam thereon; and
a deflective optical element functionally coupled with the laser emitting element and configured to direct the laser beam to a region on and/or beneath the duodenal wall.

### Claim 25 (depends on 24)

The device of claim 24, wherein said 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 said first and second fibers are spatially off-set.

### Claim 26 (depends on 25)

The device of claim 25, wherein the laser transmitting element further comprises a lens configured to deflect the first laser beam, such that the first and second laser beams are transmitted towards different target areas of the duodenal wall and/or such that said second laser beam impinges on a given target area at a delay relative to the impingement of the first laser beam, when said deflective optical elements are rotated.

### Claim 27 (depends on 24)

The device of claim 24, wherein said laser emitting element comprises a double cladded fiber, wherein the first laser beam is delivered through a core of said double cladded fiber and wherein said second beam is delivered through the clad of said double cladded fiber.

### Claim 28 (depends on 27)

The device of claim 27, wherein the laser transmitting element further comprises a dispersive element configured to selectively refract said first and/or second laser beam, such that the first and second laser beams are transmitted towards different target areas of the duodenal wall and/or such that said second laser beam impinges on a given target area at a delay relative to the impingement of the first laser beam, when said deflective optical elements are rotated.

### Claim 29 (depends on 24)

The device of claim 24, wherein the first wavelength is 1550 nm or 1567 nm.

### Claim 30 (depends on 24)

The device of claim 24, wherein the second wavelength is 980 nm.

### Claim 31 (depends on 24)

The device of claim 24, wherein the second spot diameter is larger than the first spot diameter, thereby enabling evaluation of ablative damage caused to tissue directly and indirectly affected by the first laser beam.

### Claim 32 (depends on 24)

The device of claim 24, further comprising a processing circuitry configured to evaluate the extent of impact on the region of the duodenal wall, based on the detected modifications therein.

### Claim 33

A method for real-time evaluation of duodenal ablation, the method comprising:
inserting a catheter into a duodenum of a subject;
deploying an expandable member delivered by the catheter, thereby stretching the duodenal wall and generating a fixed distance between a center of the catheter and the duodenal wall;
transmitting a first laser beam in a direction essentially perpendicular to a longitudinal axis of the catheter, towards the duodenal wall, wherein the first laser beam has a first wavelength and a first spot diameter and is configured to cause ablative damage in a region of the duodenal 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 wavelength and a second spot diameter and is configured to detect modifications in the region of the duodenal wall as a result of the impingement of the first laser beam thereon, and
evaluating the extent of impact on the region of the duodenal wall, based on the detected modifications therein.

### Claim 34 (depends on 33)

The method of claim 33, wherein the first wavelength is in the range of 1450-1600 nm.

### Claim 35 (depends on 34)

The method of claim 34, wherein the first wavelength is 1550 nm and wherein the second wavelength is 980 nm.

### Claim 36 (depends on 33)

The method of claim 33, wherein the second spot diameter is larger than the first spot diameter, thereby enabling evaluation of ablative damage caused to tissue directly and indirectly affected by the first laser beam.

### Claim 37 (depends on 33)

The method of claim 33, wherein the expandable member comprises a non-compliant balloon.

### Claim 38 (depends on 33)

The method of claim 33, wherein the second laser beam is transmitted to said region of the duodenal wall at a delay relative to the transmission of the first laser beam to said region of the duodenal wall.

### Claim 39 (depends on 38)

The method of claim 38, wherein the delay is in the range of 0.1-10 sec.

### Claim 40 (depends on 33)

The method of claim 33, wherein the first and second laser beams are transmitted simultaneously towards different target areas of the duodenal wall.

### Claim 41 (depends on 33)

The method of claim 33, further comprising rotating a deflective optical element, such that said first and/or second laser beam are deflected toward the duodenal wall in an essentially circumferential pattern.

### Claim 42 (depends on 33)

The method of claim 33, wherein evaluating the extent of impact on the region of the duodenal wall comprises determining the depth and/or width of the ablative damage.

### Claim 43 (depends on 33)

The method of claim 33, further comprising adjusting parameters related to the first laser beam, based on the evaluated extent of impact on the region of the duodenal wall detected by the second laser beam.
