DK180719B1

DK180719B1 - Medical visualisation device

Info

Publication number: DK180719B1
Application number: DKPA202070273A
Authority: DK
Inventors: Hjortlund Jonas; Abicht Felix-Johannes; Wilhelm Schütz Günter; Mat Matthison-Hansen Kaspar
Original assignee: Ambu As
Priority date: 2020-04-30
Filing date: 2020-04-30
Publication date: 2022-01-19
Also published as: DK202070273A1; EP4114245A1; WO2021219648A1

Abstract

Disclosed is a method and a medical visualisation device comprising an instrument elevator having a guide surface for engagement with an instrument protruding through a tip part instrument channel. The instrument elevator being pivotable around a pivot axis to adjust a guide angle between the guide surface and a longitudinal axis. The pivot axis being substantially perpendicular to the longitudinal axis and a viewing direction. A control wire being coupled to the instrument elevator to transfer a force exerted on the control wire to the instrument elevator to adjust the guide angle.

Description

DK 180719 B1 1

MEDICAL VISUALISATION DEVICE The present disclosure relates to a medical visualisation device, such as an endoscope, more particularly a gastroscope, such as a duodenum endoscope. The present disclosure further relates to an instrument elevator and a tip part comprising such elevator, for an endoscope. The present disclosure also relates to a method for assembly of a medical visualisation device and/or parts thereof.

BACKGROUND In endoscopes, such as a duodenum endoscope, e.g. for endoscopic retrograde cholangiopancreatography (ERCP) an elevator, alternatively denoted an Albarran lever, may be provided to adjust an angle of an instrument extending from the tip of the endoscope.

ERCP is a technique used to diagnose and treat certain problems of the biliary or pancreatic ductal systems. ERCP is used primarily to diagnose and treat conditions of the bile ducts and main pancreatic duct including gallstones, inflammatory strictures, leaks, and cancer. ERCP can be performed for diagnostic and therapeutic reasons.

ERCP may be performed using a side viewing endoscope, i.e. an endoscope where the view from the tip is angled, e.g. perpendicular, to the longitudinal axis of the endoscope tube. Also, the endoscope may comprise a side opening of a working channel, and an elevator, i.e. an Albarran lever, may be provided to adjust the angle of the instrument extending out through the side opening of the tip, to aid the operator to project the instrument to a specific area, such as to extend into the patient's bile papilla.

An elevator and its control means may be complex as it needs to be both small to fit into the endoscope and also needs to withstand a significant stress as the operator raises and lowers the elevator. Particularly for single-use endoscopes it may be challenging to provide a solution which balances the necessary strength with a cost enabling a disposable solution.

— EP 3403566 Al describes an endoscope and an endoscope cover that is to be attached to a distal framing portion of an endoscope. The endoscope includes, at the distal framing portion, a swing mechanism for suitably adjusting the orientation of a treatment instrument passing through a channel.

SUMMARY It is an object of the present disclosure to provide solutions for providing an enhanced instrument elevator and/or an enhanced tip part comprising such elevator, which overcome or reduce at least some of the limitations of the prior art. Furthermore, it is an objective of the present disclosure to

, DK 180719 B1 provide solutions, which may facilitate provision of a disposable endoscope comprising an instrument elevator.

The invention is defined by the independent claim. The dependent claims define advantageous embodiments. These embodiments and additional non-claimed embodiments, which are examples of related techniques to help understanding the claimed invention, are further described below. The described embodiments are not to be regarded as necessarily defining the invention unless they fall within the scope of the claims. Thus, the present disclosure relates to a medical visualisation device, such as an endoscope, more particularly a gastroscope, such as a duodenum endoscope. The present disclosure further relates to an instrument elevator and a tip part comprising such elevator, for an endoscope. The present disclosure also relates to a method for assembly of a medical visualisation device and/or parts thereof. Accordingly, an instrument elevator for a tip part of a medical visualisation device is disclosed. The instrument elevator has a guide surface for engagement with an instrument protruding through an instrument opening of the tip part. The instrument elevator is configured for adjusting the angle of the instrument by pivoting around a pivot axis. Also, a medical visualisation device is disclosed. The medical visualisation device comprises a handle and an insertion tube extending from the handle to a distal tube end. The insertion tube comprises a first channel, a second channel. A control wire extends through the second channel. The medical visualisation device comprises a tip part at the distal tube end. The tip part has a tip part housing extending from the distal tube end along a longitudinal axis. The tip part housing may be substantially cylindrical along the longitudinal axis. The tip part comprises a window portion, e.g. forming part of a side wall of the tip part housing, and allowing a view from the interior of the tip part housing in a viewing direction being substantially perpendicular to the longitudinal axis, e.g. the viewing direction may be a radial direction. The window portion may consist essentially of a transparent material. Alternatively or additionally, the window portion may comprise an opening formed by the tip part housing. The tip part further comprises a tip part instrument channel with an instrument opening defined by the tip part housing. The tip part instrument channel is coupled with the first channel of the insertion tube allowing an instrument being inserted through the first channel to protrude through the tip part instrument channel and distally out through the instrument opening.

DK 180719 B1 3 The tip part further comprises an instrument elevator, such as the instrument elevator described above, having a guide surface for engagement with the instrument protruding through the tip part instrument channel. The instrument elevator is pivotable around a pivot axis to adjust a guide angle between the guide surface and the longitudinal axis. The pivot axis is substantially perpendicular to the longitudinal axis and the viewing direction. The control wire is coupled to the instrument elevator to transfer a force exerted on the control wire to the instrument elevator to adjust the guide angle. A method for assembly of a medical visualisation device, such as the herein described medical visualisation device, is also disclosed.

BRIEF DESCRIPTION OF THE FIGURES Embodiments of the disclosure will be described in more detail in the following with regard to the accompanying figures. The figures show one way of implementing the present disclosure and are not to be construed as being limiting to other possible embodiments falling within the scope of the attached claim set. Fig. 1 is a schematic diagram illustrating an exemplary visualisation system; — Fig. 2 is a schematic diagram illustrating an exemplary insertion tube; Fig. 3 is a schematic diagram illustrating an exemplary tip part; Fig. 4 is a schematic diagram illustrating an exemplary tip part; Fig. 5 is a schematic diagram illustrating the exemplary instrument elevator with an exemplary connected control wire; Figs. 6A and 6B schematically illustrates an exemplary tip part; Figs. 7A-7C are schematic diagrams illustrating in side views an exemplary instrument elevator with an exemplary connected control wire; Figs. 8A and 8B are schematic diagrams illustrating in side views an exemplary instrument elevator with an exemplary connected control wire; — Fig. 9 is a schematic diagram illustrating an exemplary tip part; Figs. 10A and 10B are schematic diagrams illustrating an exemplary tip part Fig. 11A is a schematic diagram illustrating an exemplary tip part;

DK 180719 B1 4 Fig. 11B is a schematic diagram illustrating an exemplary sidewall element; Fig. 12A is a schematic diagram illustrating a bottom of an exemplary tip part; Fig. 12B is a schematic diagram illustrating a bottom of an exemplary instrument elevator; and Fig. 13 is a block diagram of an exemplary method.

DETAILED DESCRIPTION The insertion tube of the medical visualisation device may be at least partly flexible. For example, the insertion tube may comprise a bendable section, e.g. near the distal end of the insertion tube. The bendable section may be operated to direct the distal tube end and/or the tip part in a desired direction. The medical visualisation device may comprise one or more control knobs operable to direct the distal tube end and/or the tip part in a desired direction, e.g. by bending of the bendable section. The tip part may comprise a camera arranged to look through the window portion in the viewing direction. Alternatively, optical fibres may be provided, e.g. arranged through the insertion tube, to transfer an image of the view through the window portion to a camera sensor arranged remotely from the window portion, e.g. in the handle. The tip part may comprise one or more light sources, e.g. LEDs, for providing illumination in the viewing direction. The insertion tube may comprise one or more electrical conductors, e.g. to transmit a camera signal indicative of image data generated by the camera through the insertion tube and/or to provide signals to the light sources to increase — or decrease illumination. The instrument elevator may be pivotable between a lowered position and a raised position. In the lowered position the guide angles may be minimized. In the raised position the guide angle may be maximized. The instrument elevator may be pivoted between 50-90 degrees, such as between 60- 80 degrees, such as about 70 degrees, between the lowered position and the raised position. The instrument elevator may be made of polymer, such as polyoxymethylene (POM). POM is particularly advantageous as it facilitates a low friction guide surface. The tip part may be made of a polymeric material, such as a thermoplastic elastomer (TPE), such as Styrene Butadiene Copolymer (SBC), e.g. K-resin. The control wire may be a high strength steel wire. The control wire may have a wire diameter, e.g. between 0.3-0.5 mm, such as 0.4 mm.

. DK 180719 B1 The control wire may be a solid wire, alternatively denoted a monofilament wire.

Utilizing a control wire may increase the buckling strength of the wire, thus improving pushing performance and reduce the risk of the wire curling up upon pushing.

It is a further advantage of the solid wire that it may aid in reducing the wire diameter.

Furthermore, the use of a solid wire reduces the risk of the wire curling up inside the top housing.

The control wire may extend from a proximal end to a distal end.

The proximal end may be arranged at the handle.

The distal end may be arranged at the instrument elevator.

The control wire may comprise a distal portion extending to the distal end, e.g. from an intermediate position of the control wire.

The control wire may have a primary segment and a secondary segment.

Additionally, the control wire may comprise a tertiary segment.

The distal portion of the control wire may comprise the secondary segment and/or the tertiary segment.

The secondary segment may be between the primary segment and the secondary segment.

The primary segment and the tertiary segment may be substantially parallel.

The secondary segment may be substantially parallel to the pivot axis.

The control wire may comprise a first bend between the primary segment and the secondary segment.

The control wire may comprise a second bend between the secondary segment and the tertiary segment.

The first bend may be between 80-100 degrees, such as between 85-95 degrees, such as 90 degrees.

The second bend may be between 80-100 degrees, such as between 85-95 degrees, such as 90 degrees.

The angle of the bends may denote the change of direction of the control wire, i.e. — 0 degrees is equivalent to no bend, while 180 degrees is equivalent to a U-shaped bend.

The first bend may have a minimum radius of curvature between 0.1-0.5 mm.

The second bend may have a minimum radius of curvature between 0.2-1.5 mm.

The second bend may have a minimum radius of curvature bigger than the minimum radius of curvature of the first bend.

The instrument elevator may comprise a coupling part.

The coupling part may have a conduit.

The primary segment may be arranged on a first side of the coupling part along the pivot axis.

The secondary segment may extend through the conduit.

The tertiary segment may be arranged on a second side of the coupling part.

The second side may be opposite the first side of the coupling part along the pivot axis.

By providing the bend(s) on the sides of the coupling part of the instrument elevator and threading the control wire through the conduit of the coupling part, the control wire may be coupled to the instrument elevator.

DK 180719 B1 The tip part may comprise a sleeve element, e.g. enclosing the secondary segment and/or the tertiary segment of the control wire. The sleeve element may be metal. The sleeve element may provide increased stiffness to the control wire. The control wire may further restrict the control wire from being pulled out of the conduit of the instrument elevator.

5 The sleeve element may be secured to the control wire by compression of one or more portions of the sleeve element enclosing a portion of the control wire, e.g. with a crimping tool. For example, the sleeve element may be secured to the secondary segment by compression of a first portion of the sleeve element enclosing at least a portion of the secondary segment, such as a proximal or distal end of the secondary segment. Alternatively or additionally, the sleeve element may be secured to the tertiary segment by compression of a second portion of the sleeve element enclosing at least a portion of the tertiary segment, such as a proximal or distal end of the tertiary segment. It is particularly advantageous to secure (or primarily secure) the sleeve element to tertiary segment, in particular to the distal end of the tertiary segment, as the stress at a more distal position is reduced, due to the sleeve and bends taking absorbing some of the wire stress, compared to a more proximal position. Thereby, any minor reduction in wire stress caused by damages caused by the compression of the sleeve, may be less critical, as the experienced stress is submaximal. The sleeve element and the control wire may be bent together, e.g. during forming of the second bend, and such that the sleeve element encloses the second bend. Thereby, the control wire may be protected by the sleeve element to prevent breaking of the wire. Thus, the sleeve element may be attached to the control wire prior to performing the second bend. It is an advantage of fixating the wire by bends and/or a sleeve as described that thermal solutions, e.g. welding or soldering may be avoided, thereby reducing variance in fixation strength caused by heating of the materials. Providing for a more reliable and predictable strength of the coupling. Because the instrument elevator is located near the window portion, and therefore close to the field — of view, and in some positions within the field of view from the window portion. The instrument elevator may be found to affect the view through the window portion. For example, the instrument elevator may reflect or absorb light, resulting in overexposure or underexposure of images, e.g. captured by the camera. Therefore, the inventors have found that it will be advantageous to provide the instrument elevator, such as the guide surface of the instrument elevator, in a colour which balances the reflected light. Thus, the instrument elevator, such as the guide surface, has an elevator colour. The elevator colour may be a grey colour, e.g. a colour with L* between 15 to 75, a* between negative 10 to positive 10, such as between negative 5 and positive 5, such as 0, and b* between negative 10 to positive 10, , such as between negative 5 and positive 5, such as 0, as measured by

, DK 180719 B1 a CIEL*a*b* colour code system. In the CIEL*a*b* system L* is a measure of lightness from black (0) to white (100), a* is a measure of green/red from green (negative 100) to red (positive 100), and b* is a measure of blue/yellow from blue (negative 100) to yellow (positive 100). One particular example of the elevator colour may be CIEL*a*b* (34.33, -3.97, -6.66), which may be equivalent to Pantone 425c, or CMYK (63, 51, 45, 33).

The tip part may comprise an axle extending along the pivot axis. The instrument elevator may comprise an axle opening adapted to receive the axle. The axle of the tip part may extend through the axle opening of the instrument elevator. The instrument elevator may be adapted to pivot around the axle.

The tip part may comprise an intermediate wall separating the tip part instrument channel and a control wire compartment. The control wire compartment may be coupled with the second channel of the insertion tube. The intermediate wall may define an intermediate wall opening, e.g. a semi- circular opening, between the tip part instrument channel and the control wire compartment. The control wire may extend through the control wire compartment and through the intermediate wall — opening to the instrument elevator in the tip part instrument channel.

The control wire compartment may comprise a ceiling surface, e.g. between the distal tube end and the intermediate wall opening along the longitudinal axis. The ceiling surface may be configured for engagement with the control wire, e.g. to limit deflection of the control wire in the viewing direction, and to transfer a pushing force exerted on the control wire, which may result in the control wire being deflected, to the instrument elevator to minimize the guide angle.

The tip part housing may comprise a secondary opening between the tip part instrument channel and the exterior of the tip part housing. The secondary opening may be provided opposite the instrument opening, e.g. along the viewing direction.

The instrument elevator may comprise a protruding wall, e.g. opposite the guide surface. and wherein the protruding wall blocks part of the secondary opening when the instrument elevator is in the lowered position. The protruding wall may comprise a surface area smaller than the area of the secondary opening. The protruding wall may be provided to facilitate breaking of, e.g., gallstones having entered into the housing. Thus, the protruding wall may be denoted a gallstone breaking element. The secondary opening allows fragments, e.g. of broken gallstones, to be pushed out of the housing, to ensure that the instrument elevator is not prevented from being positioned in the lowered position. The surface area of the protruding wall may be smaller than 1 mm~2, such as smaller than 0.50 mm”/2, such as smaller than 0.4 mm/2. The surface area of the secondary opening may be between 3-8 mm”2, such as between 4-6 mm”2, such as approximately 5 mm”2.

2 DK 180719 B1 The instrument elevator may comprise one or more support points, e.g. including a first support point and/or a second support point, to prevent rotation of the instrument elevator about the longitudinal axis and/or about the viewing direction. The first support point may be on the first side of the instrument elevator along the pivot axis. The second support point may be on the second side — of the instrument elevator along the pivot axis. The second side of the instrument elevator may be opposite the first side of the instrument elevator. The first support point may be arranged to contact a first sidewall of the tip part instrument channel and/or the second support point may be arranged to contact a second sidewall of the tip part instrument channel, e.g. for all positions of the instrument elevator between the lowered position and the raised position. The second sidewall may be opposite the first sidewall. A distance between the distal tube end and the first support point may be larger than a distance between the distal tube end and the conduit of the instrument elevator. A distance between the distal tube end and the second support point may be smaller than a distance between the distal tube end and the conduit of the instrument elevator.

The disclosed method for assembly of the medical visualisation device may comprise providing a tip part housing, such as the tip part housing as described above, wherein the tip part instrument channel is couplable to the first channel of the medical visualisation device. The method further comprises providing an instrument elevator, such as the instrument elevator as described above, and providing a control wire such as the control wire described above.

The method comprises coupling the distal portion, e.g. the secondary segment and/or the tertiary segment, of the control wire to the instrument elevator, such as to the coupling part of the instrument elevator.

Coupling the distal portion of the control wire to the instrument elevator may comprise inserting the control wire through the conduit of the coupling part of the instrument elevator, e.g. such that the primary segment of the control wire is arranged on the first side of the coupling part and the secondary segment of the control wire is extending through the conduit, and optionally such that the tertiary segment of the control wire is arranged on the second side of the coupling part. Coupling the distal portion of the control wire to the instrument elevator may comprise bending the control wire to obtain the first bend between the primary segment and the secondary segment and/or the second bend between the secondary segment and the tertiary segment.

Coupling the distal portion of the control wire to the instrument elevator may comprise securing a sleeve element, such as the sleeve element as described above, to the distal portion of the control wire such that the distal portion of the control wire is enclosed by the sleeve element. Securing the sleeve element to the distal portion of the control wire may comprise compressing, e.g. with a

2 DK 180719 B1 crimping tool, a portion, such as the first portion and/or the second portion, of the sleeve element enclosing at least a portion of the distal portion of the control wire. The sleeve element may be secured to the distal portion of the control wire prior to bending the control wire to obtain the second bend. Bending the control wire to obtain the second may include concurrently bending the sleeve element and the control wire to obtain the second bend. The sleeve element may be secured prior to bending the control wire. The second bend, e.g. concurrently bending the sleeve element and the control wire, may be provided after securing the sleeve element. The control wire, and optionally the sleeve element, may be inserted through the conduit of the coupling part after the second bend has been provided. The first bend may be provided after inserting the control wire through the conduit of the coupling part, i.e. while the control wire and the sleeve element is extending through the conduit.

After coupling the distal portion of the control wire to the instrument elevator, the method comprises passing the control wire through the instrument opening of the tip part housing, and optionally through the first channel of the insertion tube, in a proximal direction, and inserting the instrument elevator together with the distal portion of the control wire through the instrument opening of the tip part housing, to position the instrument elevator in a seat for the instrument elevator in the tip part instrument channel. Upon insertion into the seat, the instrument elevator may snap into place and may be retained by the tip part housing. The instrument elevator and the distal portion of the control wire may be inserted through the instrument opening when the remainder of the control wire has been passed through the instrument opening. Hence, the control wire and the instrument elevator may follow each other through the instrument opening in the proximal direction.

Passing the control wire through the instrument opening of the tip part housing may include passing the control wire through the intermediate wall opening and through the control wire compartment of the tip part housing.

The method may comprise inserting the axle through the axle opening of the instrument elevator, e.g. after inserting the instrument elevator together with the distal portion of the control wire through the instrument opening. Insertion of the axle may lock the instrument elevator in its position. The axle opening of the instrument elevator may be aligned with an axle opening of the tip part housing, and the axle may be inserted through the axle opening of the tip part housing and the axle opening of the instrument elevator. The axle opening of the tip part housing may be provided in the intermediate wall separating the top part instrument channel and the control wire compartment. A sidewall element may be provided comprising the axle, and the method may comprise attaching the sidewall element to the tip part housing including inserting the axle through the axle opening of the instrument elevator and/or through the axle opening of the tip part housing.

DK 180719 B1 10 The method may further comprise providing a handle and an insertion tube, such as the handle and insertion tube as described above.

The method may comprise attaching the tip part housing to the distal tube end.

The control wire may extend through the second channel of the insertion tube prior to coupling the distal portion of the control wire to the instrument elevator.

The method may comprise threading the distal end of the control wire through the instrument opening of the tip part housing, optionally through the control wire compartment and through the intermediate wall opening, in a distal direction prior to coupling the distal portion of the control wire to the instrument elevator.

After coupling the distal portion of the control wire to the instrument elevator the control wire may be reversed and passed back through the instrument opening in the proximal direction.

Alternatively, the method may comprise, after coupling the distal portion of the control wire to the instrument elevator, threading the proximal end of the control wire through the instrument opening of the tip part housing, optionally through the intermediate wall opening and through the control wire compartment, in a proximal direction.

After threading the proximal end of the control wire through the instrument opening, the remainder of the control wire may follow and be passed through the instrument opening in the proximal direction.

Various exemplary embodiments and details are described hereinafter, with reference to the figures when relevant.

It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures.

It should also be noted that the figures are only intended to facilitate the description of the embodiments.

They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention.

In addition, an illustrated embodiment needs not have all the aspects or advantages shown.

An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any — other embodiments even if not so illustrated, or if not so explicitly described.

Fig. 1 is a schematic diagram illustrating an exemplary visualisation system 2 comprising an exemplary medical visualisation device 10, illustrated in Fig. 1A, and an exemplary monitor device 4, illustrated in Fig. 1B.

The visualisation device 10 comprises a handle 12 and an insertion tube 14. The insertion tube 14 extends from the handle 12, e.g. a proximal tube end 16, to a distal tube end 18. The medical visualisation device 10 comprises a tip part 100 at the distal tube end 18. The insertion tube 14 may be at least partly flexible, and may comprise a bendable section, which may be operated to direct the distal tube end 18 and the tip part 100 in a desired direction.

The medical visualisation device

DK 180719 B1 11 10 may comprises a control knob 28, as illustrated, which may be operated to direct the distal tube end 18 and the tip part 100 in a desired direction.

The medical visualisation device 10, e.g. the handle 12, comprises an instrument port 19, connected with a first channel of the insertion tube 14 (see Fig. 2), thereby allowing an instrument to be inserted through the instrument port 19 to protrude through the insertion tube 14 to the tip part

100.

The visualisation device 10 comprises a device connector 11 configured to be received by a monitor connector 6 of the monitor device 4, such as to allow display, on a display 8 of the monitor device 6, of an image representative of a view of a camera in the tip part 100 of the visualisation device

10.

Fig. 2 is a schematic diagram illustrating an exemplary insertion tube 14, such as the insertion tube of the visualisation device 10 as illustrated in Fig. 1A.

The insertion tube 14 comprises a first channel 20 and a second channel 22. The first channel 20 is configured for receiving an instrument being inserted from the handle of the visualisation device and extending to the tip part. For example, an instrument may be inserted through the first channel 20 and used to take samples of tissue, i.e. biopsies, near the tip part. A control wire 30 is extending through the second channel 22. The control wire 30 may be a solid wire, such as a monofilament wire. For example, the control wire 30 may be a high strength steel wire. The insertion tube 14 may comprise channels in addition to those shown. For example, the insertion tube 14 may comprise steering wires for control of a bendable section of the insertion tube 14. However, for simplicity, these are omitted from the present schematic illustration. Also, some of the illustrated channels may be omitted by arranging some of the elements directly in the lumen of the insertion tube 14. For example, the control wire 30 may be arranged directly in the lumen, whereby the lumen may constitute the second channel 22 through which the control wire 30 extends.

— The insertion tube 14 comprises one or more electrical conductors 24 (here illustrated as one wire, optionally comprising several conductors) to transmit a camera signal indicative of image data generated by a camera through the insertion tube 14, e.g. from the tip part to the handle and optionally to a display connected to the handle, as described above. The electrical conductors 24 may also be utilized to control light sources at the tip part, such as to illuminate an area in front of the camera. In alternative exemplary visualisation devices, the insertion tube may comprise optical fibres instead of the electrical conductors 24, such as to facilitate transmission of light between the tip part and the handle.

DK 180719 B1 12 Fig. 3 is a schematic diagram illustrating an exemplary tip part 100, such as the tip part 100 of the visualisation device 10 as illustrated in Fig. 1A. The tip part 100 has a tip part housing 102. The tip part 100 and/or the tip part housing 102 extends from the distal tube end 18 (see Fig. 1A) along a longitudinal axis L.

The tip part 100 comprises a window portion 104, e.g. forming part of a side wall 106 of the tip part housing 102. The window portion 104 allows a view from the interior of the tip part housing 102 in a viewing direction V. The viewing direction V is substantially perpendicular to the longitudinal axis L. For example, the tip part may comprise a camera (see Fig. 4), arranged to look through the window portion 104 in the viewing direction V.

Thetip part 100 comprises a tip part instrument channel 110 with an instrument opening 112 defined by the tip part housing 102. The tip part instrument channel 110 is configured to be coupled with the first channel 20 of the insertion tube 14 (see Figs. 1A and 2), thereby allowing an instrument being inserted through the first channel 20, e.g. via the instrument port 19, to protrude through the tip part instrument channel 110 and distally out through the instrument opening 112.

The tip part 100 comprises an instrument elevator 200 configured for directing an instrument being inserted through the first channel in a desired direction. The instrument elevator 200 has a guide surface 202 for engaging with an instrument protruding through the tip part instrument channel 110. The instrument elevator 200 is described in more detail below. The instrument elevator 200 is pivotable around a pivot axis P to adjust a guide angle between the guide surface 202 and the longitudinal axis L. The pivot axis P is substantially perpendicular to the longitudinal axis L and substantially perpendicular to the viewing direction V.

The control wire 30 (see Fig. 2) is coupled to the instrument elevator 200 to transfer a force exerted on the control wire 30 to the instrument elevator 200 to adjust the guide angle. The control wire 30 may be connected to the control knob 28 (see Fig. 1A), such that the operator may alter the guide angle of the instrument elevator 200 by operating the control knob 28 on the handle 12, which may have a designated dial or lever for operating the instrument elevator 200.

The tip part 110 comprises a sidewall element 117 covering a control wire compartment. Fig. 4 is a schematic diagram illustrating the exemplary tip part 100 of Fig. 3 with part of the housing removed. As seen, the tip part 100 comprises a camera 114 arranged to look in the viewing direction — V,e.g.through the window portion as explained above. Also, the tip part 100 comprises one or more light sources 116, in the illustrated example two light sources 116, for providing illumination in the viewing direction V. One or more electrical conductors 24 (see Fig. 2) may be provided to transmit a camera signal indicative of image data generated by the camera 114 through the insertion tube

DK 180719 B1 13

14. Similarly, the one or more electrical conductors 24 may provide power to the light sources 116 to increase or decrease illumination.

Fig. 5 is a schematic diagram illustrating the exemplary instrument elevator 200 with the control wire 30 being connected, such that pulling the control wire 30 results in the instrument elevator 200 being raised and pushing the control wire 30 results in the instrument elevator 200 being lowered.

Hence, the guide angle may be increased or decreased. Utilizing a solid wire may promote better ability to lower the instrument elevator 200 by pushing the control wire 30, as a solid wire has less tendency to buckle upon compression.

Figs. 6A and 6B schematically illustrates the tip part 100 as described with respect to the previous figures, with the instrument elevator 200 being in a lowered position in Fig. 6A and in a raised position in Fig. 6B.

As seen in Fig. 6B, in the raised position (and in other positions between the lowered position and the raised position), the instrument elevator 200 may be within the field of view of the camera and/or may be in a position where light is reflected from the instrument elevator 200 and affects the image captured through the window portion 104, a dark surface may cause shadows and a bright surface may cause overexposure. Therefore, it may be advantageous to provide the instrument elevator in a colour which balances the reflected light, such as a grey colour e.g. a colour with L* between 15 to 75, a* between negative 10 to positive 10, and b* between negative 10 to positive 10, as measured by a CIEL*a*b* colour code system.

Figs. 7A-7C are schematic diagrams illustrating, in a side view, the instrument elevator 200 being in different positions with a varying guide angle 204 between the guide surface 202 and the longitudinal axis L. In Fig. 7A, the instrument elevator 200 is in a lowered position. In Fig. 7B, the instrument elevator 200 is in an intermediate position, wherein the guide angle 204 is bigger than in the lowered position. In Fig. 7C, the instrument elevator 200 is in a raised position, wherein the guide angle 204 — is bigger than in the intermediate position. For example, the guide angle 204 may be 40 degrees in the lowered position, 85 degrees in the intermediate position, and 120 degrees in the raised position. As illustrated, the instrument elevator 200 pivots around a pivot axis P. More particularly, an axle may extend through the axle opening 218, to allow rotation of the instrument elevator 200.

Figs. 8A and 8B are schematic diagrams illustrating the instrument elevator 200 with the control wire — 30, as described above, from two opposite sides.

The instrument elevator 200 comprises a coupling part 206 for coupling the control wire 30 to the instrument elevator 200, such as to allow the control wire to raise and lower the instrument elevator.

DK 180719 B1 14 The coupling part 206 has a conduit 208. The control wire 30 is coupled to the instrument elevator 200 by extending through the conduit 208. Furthermore, a sleeve element 40 may be provided to further facilitate coupling of the control wire 30 to the instrument elevator 200.

Upon raising the instrument elevator 200, by pulling the control wire 30, the control wire 30 and the sleeve element 40 is allowed to rotate inside the conduit 208. Thus, the conduit has a slightly larger diameter than the sleeve element 40.

Because the control wire 30 is positioned on a first side of the instrument elevator 200, operating the instrument elevator 200 by pushing or pulling the control wire will introduce a twisting moment of the instrument elevator 200. To maintain position of the instrument elevator 200 in the tip housing, the instrument elevator comprises support points configured to contact sidewalls of the tip part. The instrument elevator 200 comprises a first support point 230 on the first side of the instrument elevator 200 (indicated in Fig. 8A) and second support point 232 on the second side of the instrument elevator 200 (indicated in Fig. 8B).

The first support point 230 is arranged to contact a first sidewall 130 of the tip part instrument channel 110 (see Fig. 10). The second support point 232 is arranged to contact a second sidewall 132 of the tip part instrument channel 110 (see Fig. 10).

A distance D1 between the distal tube end and the first support point 230 is larger than a distance DO between the distal tube end and the conduit 208 of the instrument elevator 200. A distance D2 between the distal tube end and the second support point 232 is smaller than the distance DO — between the distal tube end and the conduit 208 of the instrument elevator 200. Thereby, the first support point 230 and the second support point 232 counteracts the twisting moment of the instrument elevator 200 induced by the force applied by the control wire 30. In particular, the distances as illustrated is advantageous for counteracting the twisting moment induced by pulling the control wire.

— Fig. 9 is a schematic diagram illustrating the tip part 100, as described with respect to the previous figures. In Fig. 9 the part of the tip part 100 comprising the instrument elevator 200 is shown in cross section, to allow illustration of elements enclosed therein.

In coupling the control wire 30 to the instrument elevator 200, it is desired that pulling the control wire 30 does not result in the control wire being pulled of the instrument elevator 200.

— To couple the control wire 30 to the instrument elevator 200, the control wire has a primary segment 32 and a secondary segment 34. The control wire 30 further comprising a first bend 33 between the primary segment 32 and the secondary segment 34. The primary segment 32 is arranged on a first

DK 180719 B1 15 side of the coupling part 206 along the pivot axis P and the secondary segment 34 extends through the conduit 208 of the coupling part 206. The first bend 33 may be about 90 degrees, as illustrated, or may be more than 90 degrees, i.e. bent more than illustrated, or may be less than 90 degrees, i.e. bent less than illustrated. The secondary segment 34 is parallel to the pivot axis P.

In the illustrated example, the control wire 30 further has a tertiary segment 36. The secondary segment 34 is between the primary segment 32 and the tertiary segment 36. The control wire 30 further comprises a second bend 35 between the secondary segment 34 and the tertiary segment

36. The tertiary segment 34 may be arranged on a second side of the coupling part 206, as seen in Fig. 8B. The second side may be opposite the first side of the coupling part 206 along the pivot axis P. The second bend 35 may be about 90 degrees, as illustrated, or may be more than 90 degrees, i.e. bent more than 90 degrees as illustrated, or may be less than 90 degrees, i.e. bent less than 90 degrees as illustrated. As illustrated, the primary segment 32 and the tertiary segment 36 may be substantially parallel. In some exemplary embodiments, the second bend 35 is more than 90 degrees, e.g. such as to curl around the coupling part 206 of the instrument elevator.

A housing inner side wall 134 prevents the control wire 30, such as the secondary segment 34 of the control wire 30, from being pulled out of the conduit 208 and maintain attachment of the control wire 30 to the instrument elevator 200, during pulling on the control wire.

A sleeve element 40 may be provided. The sleeve element 40 may further facilitate coupling of the control wire 30 to the instrument elevator 200. In the illustrated example, the sleeve element 40 enclose the secondary segment 34, the tertiary segment 36 and the second bend 35 of the control wire 30. In other exemplary embodiments, the sleeve element 40 may comprise one or more of the secondary segments 34, the tertiary segment 36 and the second bend 35. The sleeve element may be secured to the secondary segment 34 by compression of a first portion 42 of the sleeve element 40 enclosing a portion of the secondary segment 34. Alternatively or additionally, the sleeve element — 40 may be secured to the tertiary segment 36 by compression of a second portion 44 of the sleeve element 40 enclosing a portion of the tertiary segment 36.

The sleeve element 40 and the control wire 30 may be bent concurrently, i.e. the sleeve element 40 may be bent with the control wire 30, during forming of the second bend 35, such that the sleeve element 40 encloses the second bend 35 of the control wire 30.

The sleeve element 40 may provide increased stiffness to the control wire 30. Thereby, the control wire is further restricted from being pulled out of the conduit 208, because of the inability to bend around the corners at the first bend 33, i.e. between the conduit 208 and the housing inner side wall 134, and at the second bend 35.

DK 180719 B1 16 Figs. 10A and 10B are schematic diagrams illustrating the exemplary tip part 100, with the instrument elevator removed, to allow a view of the tip part instrument channel 110 and instrument opening

112. The tip part instrument channel comprises a first sidewall 130 (Fig. 10A) and a second sidewall 132 (Fig. 10B) opposite the first sidewall 130. The first sidewall 130 is a first side of an intermediate wall 120 separating the tip part instrument channel 110 and a control wire compartment 124. The intermediate wall 120 further defines an intermediate wall opening 122 between the tip part instrument channel 110 and the control wire compartment, allowing the control wire to extend from the control wire compartment to tip part instrument channel where it is coupled to the instrument elevator. Fig. 11A is a schematic diagram illustrating the exemplary tip part 100, with the sidewall element 117 removed to allow a view of the control wire compartment 124. The exemplary sidewall element 117 is illustrated in Fig. 11B. The tip part comprises an intermediate wall 120 separating the tip part instrument channel 110 and the control wire compartment 124. The control wire compartment 124 is coupled with the second — channel of the insertion tube, such that the control wire 30 being arranged in the second channel may extend into the control wire compartment 124. The intermediate wall 120 defines an intermediate wall opening 122 between the tip part instrument channel 110 and the control wire compartment 124. The control wire 30 extends through the control wire compartment 124 and through the intermediate wall opening 122 to the instrument elevator in the tip part instrument channel 110. The intermediate wall opening is arc shaped or semi-circular shaped to allow movement of the control wire 30 in accordance with a change of position of the instrument elevator, i.e. from the lowered position to the raised position. The control wire compartment 120 comprises a ceiling surface 126. The ceiling surface 126 is between the distal tube end and the intermediate wall opening 122 along the longitudinal axis L. — The ceiling surface 126 is configured for engagement with the control wire 30 to limit deflection of the control wire 30 in the viewing direction V, as illustrated by the dashed line illustrating a control wire 30" being pushed. The ceiling surface 126 thereby transfers a pushing force exerted on the control wire 30, 30’ to the instrument elevator to minimize the guide angle. In this way, the operator has the possibility to completely lower the instrument elevator. Furthermore, the ceiling surface 126 may facilitate assembly of the tip part 100, as the contact of the control wire 30 against the ceiling surface 126 aids in pushing the instrument elevator down into place. Assembly of the tip part 100 is explained in further details below with reference to Fig. 13.

DK 180719 B1 17 As seen in Fig. 11B, the tip part comprises an axle 118, which extends along the pivot axis when inserted through an axle opening 119 of the tip part housing 102 and an axle opening 218 of the instrument elevator (see Fig. 8). As illustrated, the axle 118 may be provided on the sidewall element

117. Thereby, the axle 118 may be inserted upon closing the control wire compartment 124 with the sidewall element 117. Also, the housing inner side wall 134 may be provided by the sidewall element 117. The housing inner side wall prevents the control wire 30 from being pulled out of the conduit 208 and retain the control wire 30 attached to the instrument elevator 200 (see Fig. 9). Figs. 12A and 12B are schematic diagrams respectively illustrating the bottom of the exemplary tip part 100 and the instrument elevator 200. As seen in Fig. 12A, the tip part housing 102 comprises a secondary opening 128 between the tip part instrument channel 110 and the exterior of the tip part housing 102. The secondary opening 128 is provided opposite the instrument opening 112 (see previous figures). As seen in Fig. 12B, the instrument elevator 200 comprises a protruding wall 228 opposite the guide surface 202 (see previous figures). The protruding wall 228 blocks part of the secondary opening 128, as seen in Fig. 12A, when the instrument elevator is in a lowered position. The protruding wall 228 has a surface area smaller than the area of the secondary opening 128. The small surface area of the protruding wall, e.g. smaller than 1 mm”2, may facilitate breaking of, e.g., gallstones having entered into the housing. The secondary opening 128 allows fragments to be pushed out of the housing, to ensure that the instrument elevator 200 is not prevented from being positioned in the lowered position. Fig. 13 is a block diagram of an exemplary method 300, such as a method 300 for assembly of a medical visualisation device, such as the medical visualisation device 100 as described with respect of the previous figures. The method 300 comprises: providing 302 a tip part housing, such as the tip part housing 102 as described above; providing 304 an instrument elevator having a guide surface, such as the instrument elevator 200 as described above; providing 306 a control wire extending from a proximal end to a distal end, such as the control wire 30 as described above. The control wire comprises a distal portion extending to the distal end of the control wire. The method 300 further comprises coupling 308 the distal portion of the control wire to the instrument elevator. Coupling 308 the distal portion of the control wire to the instrument elevator may comprise inserting the control wire through a conduit of a coupling part of the instrument elevator, such that a primary

DK 180719 B1 18 segment of the control wire is arranged on a first side of the coupling part and a secondary segment of the control wire is extending through the conduit.

The secondary segment forms part of the distal portion of the control wire.

The control wire may be inserted through the conduit of the instrument elevator such that a tertiary segment of the control wire is arranged on a second side of the instrument elevator.

The tertiary segment may form part of the distal portion of the control wire.

Coupling 308 the distal portion of the control wire to the instrument elevator may comprise bending the control wire to obtain a first bend between the primary segment and the secondary segment.

Coupling 308 the distal portion of the control wire to the instrument elevator may comprise bending the control wire to obtain a second bend between the tertiary segment and the secondary segment.

Coupling 308 the distal portion of the control wire to the instrument elevator may comprise securing a sleeve element to the distal portion of the control wire such that the distal portion of the control wire is enclosed by the sleeve element.

Securing the sleeve element to the distal portion of the control wire may comprise compressing a portion of the sleeve element enclosing at least a portion of the distal portion of the control wire.

The sleeve element may be secured to the distal portion of the control wire prior to bending the control wire to obtain the second bend.

In this situation bending the control wire to obtain the second may include concurrently bending the sleeve element and the control wire to obtain the second bend.

After coupling 308 the distal portion of the control wire to the instrument elevator, the method comprises passing 310 the control wire through the instrument opening of the tip part housing in a proximal direction.

The tip part housing may comprise an intermediate wall separating the tip part instrument channel and a control wire compartment (see, e.g., Fig. 11A). The intermediate wall defines an intermediate wall opening between the tip part instrument channel and the control wire compartment.

Furthermore, the control wire compartment is couplable to a second channel of the medical visualisation device.

Thus, passing 310 the control wire through the instrument opening of the tip part housing may include passing the control wire through the intermediate wall opening and through the control wire compartment.

The control wire may further be passed through the second channel of the medical visualisation device.

The method 300 may comprise threading 309a the proximal end of the control wire through the instrument opening of the tip part housing in a proximal direction after coupling 308 the distal portion of the control wire to the instrument elevator.

Alternatively, the control wire extends through the second channel of the medical visualisation device prior to coupling 308 the distal portion of the control wire to the instrument elevator.

In such situation the method 300 may comprise threading

DK 180719 B1 19 309b the distal end of the control wire through the instrument opening of the tip part housing in a distal direction prior to coupling 308 the distal portion of the control wire to the instrument elevator. The method 300 further comprises, e.g. after having passed 310 the control wire through the instrument opening in a proximal direction, inserting 312 the instrument elevator together with the distal portion of the control wire through the instrument opening of the tip part housing, such as to position the instrument elevator in a seat for the instrument elevator in the tip part instrument channel. Upon insertion 312 into the seat, the instrument elevator may snap into place after which it is retained by the tip part housing. As explained above with reference to Fig. 11A, the ceiling surface 126 (see Fig. 11A) may facilitate the insertion 312 of the instrument elevator by as the contact of the control wire 30 against the ceiling surface 126 aids in pushing the instrument elevator downwards, such as to snap it into place.

The method 300 may further comprise inserting 316 an axle through an axle opening of the instrument elevator, and optionally through one or more axle opening of the tip part housing. A sidewall element comprising the axle may be provided, and attaching the sidewall element to the tip part housing may include inserting 316 the axle.

The method 300 may comprise, e.g. prior to inserting 316 the axle, aligning 314 the axle opening of the instrument elevator with an axle opening of the tip part housing. Thus inserting 316 the axle may comprise inserting the axle through the axle opening of the tip part housing and the axle opening of the instrument elevator.

The method 300 may comprise providing 318 a handle and an insertion tube extending from the handle to a distal tube end, the insertion tube comprising the second channel, and the method may comprise attaching 320 the tip part housing to the distal tube end of the insertion tube. Throughout the description, the use of the terms “first”, “second”, “third”, “fourth”, “primary”, “secondary”, “tertiary” etc. does not imply any particular order or importance but are included to identify individual elements. Furthermore, the labelling of a first element does not imply the presence of a second element and vice versa.

DK 180719 B1 20

LIST OF REFERENCES 2 visualisation system 4 monitor device 6 monitor connector 8 display medical visualisation device 11 device connector 12 handle 14 insertion tube 10 16 proximal tube end 18 distal tube end 19 instrument port 20 first channel 22 second channel 24 electrical conductors 28 control knob 30 control wire 32 primary segment 33 first bend 34 secondary segment 35 second bend 36 tertiary segment 40 sleeve element 42 first portion of sleeve element 44 second portion of sleeve element 100 tip part 102 tip part housing 104 window portion 106 side wall 110 tip part instrument channel 112 instrument opening 114 camera 116 light source 117 sidewall element 118 axle 119 axle opening 120 intermediate wall

DK 180719 B1 21 122 intermediate wall opening 124 control wire compartment 126 ceiling surface 128 secondary opening 130 first sidewall of tip part instrument channel 132 second sidewall of tip part instrument channel 134 housing inner side wall 200 instrument elevator 202 guide surface 204 guide angle 206 coupling part 208 conduit 218 axle opening 228 protruding wall 230 first support point 232 second support point 300 method 302 providing tip part housing 304 providing instrument elevator 306 providing control wire 308 coupling control wire to instrument elevator 309a threading control wire through instrument opening 309b threading control wire through instrument opening 310 passing control wire through instrument opening 312 inserting instrument elevator 314 aligning axle openings 316 inserting axle 318 providing handle and insertion tube 320 attaching tip part housing L longitudinal axis Vv viewing direction P pivot axis

Claims

DK 180719 B1 22 KRAV

A medical visualization device (10) comprising a handle (12) and an insertion tube (14) extending from the handle (12) to a distal tube end, the insertion tube (14) comprising a first channel (20), a second channel (22) , and a control wire (30) extending through the second channel, the medical visualization equipment comprising a tip portion (100) at the distal tube end, the tip portion (100) having a tip portion housing (102) extending from the distal tube end along a longitudinal axis, the tip portion ( 102) comprises: - a window part (104) allowing a view from the inside of the tip part housing (102) in a viewing direction which is substantially perpendicular to the longitudinal axis; a tip section instrument channel (110) having an instrument opening (112) defined by the tip section housing (102), the tip section instrument channel (110) being coupled to the first channel (20) or the insertion tube allowing an instrument to be inserted through the first channel (20); ) to protrude through the tip section instrument channel and distally out through the instrument opening (110); - the instrument lifter (200) having a guide surface (202) for engagement with the instrument projecting through - the tip section instrument channel (110), the instrument lifter (200) is rotatable about a pivot axis to adjust a guide angle between the guide surface (202) and the longitudinal axis, the pivot axis is substantially perpendicular to the longitudinal axis and the viewing direction, the control wire (30) is coupled to the instrument lifter (200) to transmit force exerted on the control wire (30) to the instrument lifter (200) to adjust the guide angle, the control wire (30) having a primary segment (32) and a secondary segment (34), and comprises a first buck (33) between the primary segment (32) and the secondary segment (34), the instrument lifter (200) comprising a coupling part (206) having an opening (208 ), the primary segment (32) is arranged on a first side of the coupling part (206) along the pivot axis and the secondary segment (34) extends through the opening (208), characterized in that the control wire (30) also has a tar tar see segment (36), wherein the secondary segment (34) is between the primary segment (32) and the tertiary segment (36), the control wire (30) further comprises a second buck (35) between the secondary segment (34) and the tertiary segment (36), the tertiary segment (36) is arranged on a second side of the coupling part (206), the second side being opposite the first side of the coupling part (206) along the pivot axis.

DK 180719 B1 23

The medical visualization equipment of claim 1, wherein the primary segment and the tertiary segment are substantially parallel.

Medical visualization equipment according to any one of claims 1-2, wherein the tip portion comprises an enclosing element enclosing the secondary segment and / or the tertiary segment.

Medical visualization equipment according to claim 3, wherein the enclosing element is secured to the secondary segment by compression of a first part of the enclosing element enclosing at least a part of the secondary segment, and / or wherein the enclosing element is secured to the tertiary segment by compression of a second part of the enclosing member enclosing at least a portion of the tertiary segment.

Medical visualization equipment according to any one of the preceding claims, wherein the control wire is a solid wire.

Medical visualization equipment according to any one of the preceding claims, wherein the instrument lifter is made of polyoxymethylene (POM).

Medical visualization equipment according to any one of the preceding claims, wherein the instrument lifter has a lifter color, the lifter color being a gray color, e.g. a color with LX between 15 to 75, a% between negative 10 to positive 10, and b% between negative 10 to positive 10, as measured by the CIEL * a * b * color coding system.

Medical visualization equipment according to any one of the preceding claims, wherein the tip part comprises a shaft extending along the pivot axis and through a shaft opening in the instrument lifter.

Medical visualization equipment according to any one of the preceding claims, wherein the tip portion comprises an intermediate wall dividing the tip portion instrument channel and a control wire space, the control wire space being coupled to the second channel of the insertion tube, the intermediate wall defining an intermediate wall opening between the tip portion instrument channel and the control wire space. the control wire extends through the control wire space and through the intermediate wall opening to the instrument lifter in the tip section instrument channel.

The medical visualization equipment of claim 9, wherein the control wire space comprises a top surface between the distal tube end and the intermediate wall opening along the longitudinal axis, the top surface being configured to engage the control wire to limit deflection of the control wire, and to transmit a pushing force exerted on the control wire. to the instrument lifter to minimize the guide angle.

DK 180719 B1 24

Medical visualization equipment according to any one of the preceding claims, wherein the tip part housing comprises a secondary opening between the tip part instrument channel and the exterior of the tip part housing, the secondary opening being opposite the instrument opening, the instrument lifter comprising a protruding wall opposite the guide surface and the protruding wall partially blocking the - secondary opening when the instrument lifter is in a lowered position, the protruding wall comprises a surface area less than the area of the secondary opening.

Medical visualization equipment according to any one of the preceding claims, wherein the instrument lifter comprises a first support point on the first side of the instrument lifter along the pivot axis, the first support point is arranged to touch a first side wall of the tip part - the instrument channel, and wherein a distance between the distal the tube end and the first support point are greater than a distance between the distal tube end and the opening of the instrument lifter.

Medical visualization equipment according to any one of the preceding claims, wherein the instrument lifter comprises a second support point on the other side of the instrument lifter along the pivot axis, the second support point being arranged to touch a second side wall of the tip member channel, a distance between the distal tube end and the second support point is less than a distance between the distal tube end and the opening of the instrument lifter.