# US 12,109,081 B2 · Medical device inspection scope

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- Number: US 12,109,081 B2
- Document ID: US12109081B2
- Status: Granted
- Kind: B2
- Application number: 16/351,106
- Filed: 2019-03-12
- Published: 2019-09-19
- Granted: 2024-10-08
- Earliest claimed: 2018-03-16
- Assignees: Clarus Medical, LLC
- Applicants: Clarus Medical, LLC
- Inventors: Scott Allen Sundet; Cindy Trosen Sundet; Randal Alan Gatzke; Mark Brown
- Web page: https://patentgrep.com/patent/US12109081B2

## CPC

- A61B 90/70: Cleaning devices specially adapted for surgical instruments
- A61B 1/012: characterised by internal passages or accessories therefor
- A61B 1/05: characterised by the image sensor, e.g. camera, being in the distal end portion
- A61B 1/0661: {Endoscope light sources}
- A61B 1/07: using light-conductive means, e.g. optical fibres
- A61B 90/361: {Image-producing devices, e.g. surgical cameras}
- A61L 2/10: Ultraviolet [UV] radiation
- A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour
- F21V 33/0068: {Medical equipment}
- A61B 1/00078: {with stiffening means}
- A61B 2090/306: {using optical fibres}
- A61B 2090/373: {using light, e.g. by using optical scanners}
- A61B 2090/701: {for flexible tubular instruments, e.g. endoscopes}
- A61B 2090/702: {Devices for testing the cleaning process, e.g. test soils}
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2202/11: Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
- A61L 2202/14: Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
- A61L 2202/17: Combination with washing or cleaning means
- A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement}
- A61M 2209/02: Equipment for testing the apparatus
- F21W 2131/20: Lighting for medical use
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- F21V: FUNCTIONAL FEATURES OR DETAILS OF LIGHTING DEVICES OR SYSTEMS THEREOF; STRUCTURAL COMBINATIONS OF LIGHTING DEVICES WITH OTHER ARTICLES, NOT OTHERWISE PROVIDED FOR
- 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)}
- F21W: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES F21K, F21L, F21S and F21V, RELATING TO USES OR APPLICATIONS OF LIGHTING DEVICES OR SYSTEMS

## Abstract

A medical device inspection scope may include a cylindrical outer layer having a diameter of less than 2 millimeters or even less than 1 millimeter, a cylindrical inner layer disposed concentrically within the outer layer, a circumferential space between the outer layer and the inner layer, and an inner lumen formed by the inner layer. The scope also includes multiple light transmitting fibers disposed in the circumferential space and a camera module disposed in the inner lumen. The light fibers may be designed to transmit illumination light and ultraviolet light. The scope may also optionally include a stiffening member.

## Claims

### Claim 1

A cleaning and inspection scope for cleaning and inspecting of a medical device, the cleaning and inspection scope comprising:
a cylindrical outer layer having a diameter of less than 2 millimeters;
a single inner lumen disposed inside of the cylindrical outer layer, said inner lumen being the sole lumen within the cleaning and inspection scope;
a camera module disposed in the inner lumen at a distal end of the cleaning and inspection scope, wherein the camera module is positioned entirely within the single inner lumen at the distal end of the cleaning and inspection scope;
an illuminating light source;
a disinfecting light source;
multiple light transmitting fibers disposed in the inner lumen between the camera module and the outer layer, wherein the multiple light transmitting fibers are optically coupled to the illuminating light source and to the disinfecting light source to emit illuminating light for illuminating a field of view of the cleaning and inspection scope and ultraviolet light for disinfection of an inside of the medical device; and
a stiffening member in the inner lumen for providing added stiffness to the cleaning and inspection scope.

### Claim 2 (depends on 1)

The cleaning and inspection scope of claim 1, further comprising a light source positioned in proximity to a proximal end of the cleaning and inspection scope.

### Claim 3 (depends on 1)

The cleaning and inspection scope of claim 1, wherein the camera module has a rectangular cross-sectional shape, and wherein the corners of the camera module are rounded off.

### Claim 4 (depends on 1)

The cleaning and inspection scope of claim 1, wherein the cylindrical outer layer has a diameter of less than 1 millimeter.

### Claim 5 (depends on 1)

The cleaning and inspection scope of claim 1, wherein the ultraviolet light comprises UVC light.

### Claim 6

A method for making a cleaning and inspection scope for cleaning and inspecting of a medical device, the method comprising:
providing a cylindrical outer layer having a diameter of less than 2 millimeters, a single inner lumen being disposed inside of the cylindrical outer layer;
placing a camera module in the inner lumen at a distal end of the cleaning and inspection scope, wherein the camera module is positioned entirely within the single inner lumen at the distal end of the cleaning and inspection scope; and
placing multiple light transmitting fibers in the inner lumen between the camera module and the outer layer, wherein the multiple light transmitting fibers are optically coupled to an illuminating light source configured to emit illuminating light for illuminating a field of view of the cleaning and inspection scope and to a disinfecting light source configured to emit ultraviolet light for disinfection of an inside of the medical device; and
placing a stiffening member comprising a laser fiber in the inner lumen to provide added stiffness to the cleaning and inspection scope.

### Claim 7 (depends on 6)

The method of claim 6, wherein the camera module has a rectangular cross-sectional shape, the method further comprising rounding off corners of the camera module.

### Claim 8 (depends on 6)

The method of claim 6, wherein the cylindrical outer layer has a diameter of less than 1 millimeter.

### Claim 9 (depends on 6)

The method of claim 6, wherein the ultraviolet light comprises UVC light.

### Claim 10 (depends on 1)

A method for using the cleaning and inspection scope of claim 1, the method comprising:
advancing the cleaning and inspection scope into a lumen of a medical device;
emitting illuminating light from the multiple light transmitting fibers to illuminate the lumen of the medical device; and
capturing an image of the lumen of the medical device with the camera module.

### Claim 11 (depends on 10)

The method of claim 10, further comprising preventing the cleaning and inspection scope from kinking, using the stiffening member extending through the scope.

### Claim 12 (depends on 10)

The method of claim 10, further comprising emitting ultraviolet light from the stiffening member for disinfecting the lumen of the medical device.

### Claim 13 (depends on 12)

The method of claim 12, wherein the ultraviolet light comprises UVC light.

### Claim 14 (depends on 12)

The method of claim 12, further comprising switching between emitting illuminating light and emitting ultraviolet light.

### Claim 15 (depends on 12)

The method of claim 12, wherein the illuminating light and the ultraviolet light are emitted simultaneously.

### Claim 16 (depends on 12)

The method of claim 12, wherein the medical device is selected from the group consisting of endoscopes and catheters.