# US 12,109,373 B2 · Devices and systems for an endoscopic procedure

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- Number: US 12,109,373 B2
- Document ID: US12109373B2
- Status: Granted
- Kind: B2
- Application number: 17/473,483
- Filed: 2021-09-13
- Published: 2022-03-17
- Granted: 2024-10-08
- Earliest claimed: 2020-09-15
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Kyle H. Srivastava; Vijay Koya; Jonathan B. Shute; Christopher Piere; Mark Kringle
- Web page: https://patentgrep.com/patent/US12109373B2

## CPC

- A61B 1/00097: {Sensors}
- A61M 25/0136: {Handles therefor}
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61M 25/0105: {Steering means as part of the catheter or advancing means; Markers for positioning (systems for detection of markers A61B)}
- A61B 1/018: for receiving instruments
- A61M 2025/0002: {with a pressure sensor at the distal end}
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- A61M 2205/0294: Piezoelectric materials
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3331: Pressure; Flow
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A navigation-assisting flexible elongate member, a navigation-assisting system, and a navigation-assisting method for use in navigating within a body to a treatment site. A navigation-assisting sensor, such as an optic fiber, an inductive sensor, a piezoelectric sensor, or a camera, is provided within the wall of the flexible elongate member, so as not to occupy space within a working channel defined by and through the flexible elongate member. When the distal end of the flexible elongate encounters an obstacle/another object (e.g., body tissue or a lumen wall), the navigation-assisting sensor generates a signal indicative of such encounter. Such signal is converted into information (such as by a control unit) usable to navigate the flexible elongate member away from the obstacle and on course to the treatment site.

## Claims

### Claim 1

A flexible elongate member defining a working channel sized and configured to allow instruments to be passed therethrough to perform a procedure with respect to a treatment site, said flexible elongate member comprising:
an exterior tubular wall;
an interior tubular wall positioned within the exterior tubular wall and defining an interior space between the exterior tubular wall and the interior tubular wall; and
at least one sensor positioned within said interior space;
wherein:
at least one of said exterior wall and said interior wall defines a flexible and deflectable distal end of said flexible elongate member; and
said at least one sensor is positioned in said flexible and deflectable distal end of said flexible elongate member and is configured to detect deflection of said flexible and deflectable distal end.

### Claim 2 (depends on 1)

The flexible elongate member of claim 1, wherein said at least one sensor is a pressure sensor which detects impact of said distal end of said flexible elongate member against an object.

### Claim 3 (depends on 1)

The flexible elongate member of claim 1, wherein said at least one sensor comprises one of an optic fiber, an inductive sensor, or a piezoelectric sensor.

### Claim 4 (depends on 3)

The flexible elongate member of claim 3, wherein said distal end of said flexible elongate member comprises a proximal pressure sensing segment and a distal pressure sensing segment axially movable with respect to each other.

### Claim 5 (depends on 4)

The flexible elongate member of claim 4, further comprising a biasing element biasing said proximal pressure sensing segment and said distal pressure sensing segment apart in a neutral configuration when said distal end of said flexible elongate member is not impacting an object.

### Claim 6 (depends on 4)

The flexible elongate member of claim 4, wherein said at least one sensor is provided in said proximal pressure sensing segment, and movement of said distal pressure sensing segment relative to said proximal pressure sensing segment actuates said at least one sensor to generate a signal.

### Claim 7 (depends on 6)

The flexible elongate member of claim 6, wherein said signal is indicative of said distal end of said flexible elongate member impacting an object.

### Claim 8 (depends on 7)

The flexible elongate member of claim 7, wherein said at least one sensor comprises at least three pressure sensors spaced apart to indicate directionality of impact to said distal end of said flexible elongate member.

### Claim 9 (depends on 4)

The flexible elongate member of claim 4, wherein:
said at least one sensor is a fiber optic with a distal end at a distal end of said proximal pressure sensing segment spaced apart from a proximal face of said distal pressure sensing segment;
and movement of said distal pressure sensing segment relative to said proximal pressure sensing segment causes a change in the interference pattern generated by reflection of light from said fiber optic against said proximal face of said distal pressure sensing segment indicative of pressure on said distal end of said flexible elongate member.

### Claim 10 (depends on 1)

The flexible elongate member of claim 1, wherein said at least one sensor comprises at least three sensors providing directional information.

### Claim 11 (depends on 1)

The flexible elongate member of claim 1, wherein said at least one sensor comprises at least four sensors equidistantly spaced about the periphery of said interior space.

### Claim 12 (depends on 1)

The flexible elongate member of claim 1, further comprising a camera within said interior space.

### Claim 13

A flexible elongate member comprising:
a tubular wall comprising an exterior tubular wall and interior tubular wall positioned within the exterior tubular wall to define a working channel within said interior tubular wall sized and configured to allow instruments to be passed therethrough to perform a procedure with respect to a treatment site, and an interior space between said exterior tubular wall and said interior tubular wall and extending axially between a proximal end of said flexible elongate member and a distal end of said flexible elongate member; and
at least one navigation-assisting sensor positioned within said interior space in a distal end of said flexible elongate member to generate a signal indicative of said distal end of said flexible elongate member encountering an object.

### Claim 14 (depends on 13)

The flexible elongate member of claim 13, wherein said at least one navigation-assisting sensor is a pressure sensor capable of detecting impact of said distal end of said flexible elongate member against an object.

### Claim 15 (depends on 14)

The flexible elongate member of claim 14, wherein said at least one pressure sensor comprises at least three pressure sensors providing directional information.

### Claim 16 (depends on 15)

The flexible elongate member of claim 15, wherein said at least one pressure sensor comprises at least four pressure sensors equidistantly spaced about the periphery of said interior space.

### Claim 17 (depends on 13)

The flexible elongate member of claim 13, wherein said at least one navigation-assisting sensor comprises one of an optic fiber, an inductive sensor, a piezoelectric sensor, or a camera.

### Claim 18

A system comprising:
a handle;
a flexible elongate member extending axially between a proximal end coupled to said handle and a distal end, and comprising an exterior tubular wall and interior tubular wall positioned within the exterior tubular wall to define a working channel within said interior tubular wall sized and configured to allow instruments to be passed therethrough to perform a procedure with respect to a treatment site, and an interior space between said exterior tubular wall and said interior tubular wall; and
at least one navigation-assisting sensor positioned within said interior space to generate a signal indicative of said distal end of said flexible elongate member encountering an object;
wherein:
at least one of said exterior wall and said interior wall defines a distal end of said flexible elongate member; and
said at least one navigation-assisting sensor is positioned in said distal end of said flexible elongate member.

### Claim 19 (depends on 18)

The system of claim 18, wherein said at least one navigation-assisting sensor comprises one of an optic fiber, an inductive sensor, a piezoelectric sensor, or a camera.

### Claim 20 (depends on 19)

The system of claim 19, further comprising a control unit processing signals from said at least one navigation-assisting sensor to indicate directional information with regard to impact of said distal end of said flexible elongate member against an object.
