Patent Description:
Endoscopes are known and used for visual navigation into, and examination and diagnosis of, hollow organs and body cavities, as well as, optionally, to assist in surgery, e.g. for a targeted tissue sampling. Endoscopes include procedure-specialized endoscopes, such as bronchoscopes, gastroscopes, colonoscopes and duodenoscopes. An endoscope provided with a flexible insertion cord generally includes an insertion tube, a bending section at a distal end of the insertion tube, and an observation optical system extending distally from the bending section. A control wheel is connected to the bending section by a steering wire. A user rotates the control wheel to bend the bending section. The ability to control direction of the distal end of the insertion cord facilitates navigation of the insertion cord of the endoscope through tortuous hollow organs and body cavities. Further, the user can easily observe an area of interest by directing an observation optical system arranged at a distal end portion of the insertion cord towards a target direction. An example of such endoscopes is described in e.g. <CIT>, which relates to a duodenoscope.

Procedures using endoscopes can be relatively time consuming, such as one hour or even longer, and may require some force from the user. For example, in case of a colonoscopy the user inserts the insertion cord of a colonoscope through the rectum and colon of a patient. Peristaltic movements of the colon may, however, work against forwarding the colonoscope, so the user must hold and push the insertion cord forward with one hand (typically the right hand) while holding the handle with the other hand (typically the left hand). Further, the user must at the same time operate the control wheel to direct the distal end of the insertion cord in a desired direction, which is typically done using fingers of the hand holding the handle (typically the left hand). Another example is insertion of a duodenoscope, e.g. for performing an Endoscopic Retrograde Cholangiopancreatography (ERCP), which is a very specialized and sensitive endoscopic procedure to diagnose and treat issues with the pancreatic duct, bile duct, and pancreas, where it is necessary to hold the duodenoscope in a specific position for an extended period at a treatment site, while potentially adjusting position of the distal end portion of the insertion cord by operating the control wheel, which again typically is done with fingers of the hand holding the handle (typically the left hand).

The user must be highly skilled and experienced, and as such is in high demand. The type of work is straining, intensive and repeated, which may give rise to repetitive strain injury. Further the ergonomics of the controls of known endoscopes are not ideal for all users. Users with relatively small hands may have difficulties in holding the endoscope handle and operating the endoscope controls using the same hand. This means that some users may have difficulties in performing their job or may face attrition over time.

<CIT> suggests to provide a control wheel with larger radius, e.g. as an add-on part, and similarly <CIT> suggests an add-on wheel to increase the radius of a control wheel. Those suggestions may alleviate the above mentioned problems. However, the addition of components increases complexity and cost, which is undesirable, particularly in single-use endoscopes. <CIT> discloses a control wheel according to the preamble of independent claim <NUM> comprising protrusions having a base part and an extensions part wherein the extension part is extendable from a retracted position to an extended position so as to be adaptable to different hand sizes of the operator.

For single-use endoscopes, it is important that the entire device is manufactured in a cost-efficient way. For this reason, endoscopes are mainly made of polymeric materials to enhance disposability and reduce costs.

It is desirable to improve ergonomics of endoscopes, particularly in single-use endoscopes, to improve their value.

The objective of the present disclosure is to provide an endoscope with features that eliminate or at least reduce the disadvantages of prior art endoscopes and suitably deal with the problems described above. In particular, it is an object of the present disclosure to present an endoscope, in particular a four-way endoscope, that exhibits improved ergonomics for persons with relatively small hands.

The objectives of the present disclosure are satisfied by an endoscope in accordance with claim <NUM> and by a visualization system including the endoscope and a monitor. Advantageous embodiments are claimed in the dependent claims and/or are explained herein below.

A first aspect of this disclosure relates to an endoscope comprising a proximal handle, and an insertion cord extending distally from the handle or interface, the insertion cord having distal bending section, a control wheel arranged at the handle, the control wheel having a wheel rotation axis and a perimeter comprising protrusions extending away from the wheel rotation axis, the control wheel controlling bending of the bending section by rotation of the control wheel around the wheel rotation axis, wherein at least one protrusion comprises a base part and an extension part which is extendable from a retracted position to an extended position.

By providing an endoscope as described above is achieved that the size of the control wheel may be adjusted, without the need for further parts. This ability to adjust may improve ergonomics for users and may further facilitate manipulation of the endoscope control wheel in that the force needed for rotating the control wheel may be smaller in an extended position of the extension part.

The extension part may be connected to the base part in any suitable way, for example detachably connected, such as configured to be moved from a socket corresponding to retracted position to a socket corresponding to an extended position. According to an embodiment, however, the extension part is connected to the base part via a joint. By joint is meant any connection or link allowing a turning or swinging motion between the extension part and the base part. An advantage is that the extension part is always connected to the base part, so that the extension part will not be lost, and operation is fool proof.

The joint may be any type of connection or link holding the parts together but allowing repositioning. However, according to the invention the joint is a turning joint. By turning joint is meant a connection or link allowing the extension part to be twisted from extending in a first direction to extending in a second direction, such as a joint connecting the base part to the extension part by a central tap or pin. A joint surface of the base part may be arranged at for example <NUM> degrees to a plane of the base part, and a corresponding joint surface of the extension part may be arranged at for example <NUM> degrees. An advantage of a turning joint is that further features and functions, e.g. locks or movement restrictions, may be built into the joint. As an example the joint surface of one part may be wavy, or have other surface features, and cooperating with the corresponding features of the other joint surface. Further the joint may be built-in and robust, as the joint can be formed without any exposed features.

In an alternative embodiment the joint is a hinge joint. The hinge joint can be a pin joint, where the extension part is connected to the base part at by a pin or tap to enable a rotational movement in a plane including the wheel rotation axis. This is a very intuitive solution for users.

An alternative embodiment uses a linear joint, wherein the extension part is telescopically connected to the base part, such as the extension part being housed inside the base part and slidably connected thereto. This can provide a robust joint.

As an alternative linear joint the extension part may be a telescopic spindle. Thus, the base part and extension part may be a screw pair, e.g. in that the base part comprises an internal thread and the extension part comprises an external thread, or vice versa. Such a joint will by nature have some protection against unintentional shift between retracted and extended position.

In some cases, it may be advantageous that the extension part is an L-shaped extension part configured for providing a projection protruding towards the handle, when the L-shaped extension part is in the extended position. This could further improve the reachability of the control wheel.

If considered relevant, the endoscope may further comprise an extension part lock releasably locking the extension part in the extended position. This may in some cases be advantageous to avoid accidental retraction of the extension part from the extended position during manipulation of the control wheel.

The endoscope may have any suitable number of protrusions, such as four or five, however according to an embodiment the control wheel comprises six protrusions, which is considered a favourable value to facilitate operation of the control wheel especially for users with relatively small hands.

The endoscope may have a simple solution, wherein only some of the protrusions, such as half of the protrusions comprise base part and extension part. According to an embodiment, however, all protrusions comprise base part and extension part, which from a user point of view is considered advantageous. The user then has the free choice whether one or the other or all protrusions should be extended.

According to an embodiment the retracted position corresponds to a radius rmin, and the extended position corresponds to a radius rmax and satisfying a relationship rmax = (rmin + Y mm), wherein Y denotes radius increase and advantageously having a value in the interval <NUM>-<NUM>, such as approximately <NUM>, which is found to provide improved ergonomics for a range of users. As an example rmin can be in the range of <NUM>-<NUM>, such as <NUM>, and rmax can be in the range of <NUM>-<NUM>, such as <NUM>.

An aspect of the invention relates to a visualization system comprising an endoscope according to any one of the claims above and a monitor connectable to the endoscope.

A person skilled in the art will appreciate that any one or more of the above aspects of this disclosure and embodiments thereof may be combined with any one or more of the other aspects of this disclosure and embodiments thereof.

Embodiments of this disclosure will be described in more detail in the following with regard to the accompanying figures. The figures are not to be construed as limiting other possible embodiments falling within the scope of the attached claim set.

In the following the term "distal" refers to a position farthest away from the user, whereas the term "proximal" refers to the end closest to the user when using the endoscope in a patient.

A prior art endoscope <NUM> is shown in <FIG>. The endoscope <NUM> comprises an umbilical cord <NUM> connecting the endoscope <NUM> to further equipment, such as a vacuum source, an irrigation source, an electrical power source and a monitor M. The endoscope <NUM> comprises a handle <NUM> and an insertion cord <NUM> extending from the distal end of the handle <NUM>. The insertion cord <NUM> comprises an insertion tube <NUM>, a bending section <NUM>, and a distal tip <NUM>. The endoscope <NUM> is a <NUM>-way endoscope, meaning that the bending section <NUM> may be controlled by rotating two control wheels 10a, 10b in different directions to move the distal tip <NUM> up/down and left/right. The control wheels 10a, 10b have a common rotation axis and are arranged on top of each other on the handle <NUM>. The control wheels 10a, 10b are connected via steering wires <NUM> to the bending section <NUM>. Bending the distal tip facilitate advancement of the insertion cord inside a patient. Rotation of the up/down control wheel 10a may be locked by up/down control wheel lock 13a, whereas rotation of the left/right control wheel 10b may be locked by the left/right control wheel lock 13b. The handle <NUM> also comprises a suction valve <NUM> as well as other valves and buttons.

Referring now to <FIG>, an embodiment of a novel endoscope according to the disclosure, denoted by numeral <NUM>, is presented. Unless otherwise noted, components having the same structure and/or function are denoted with the same numerals. Accordingly, the endoscope <NUM> comprises an umbilical cord <NUM> having a connector 3a connecting the endoscope to further equipment, such as the monitor M and potential auxiliary equipment A (such as irrigation water pump and vacuum source). The endoscope <NUM> and the monitor M may be referred to as a visualization system <NUM>'. The endoscope <NUM> comprises the handle <NUM>, the insertion cord <NUM>, the control wheel 10a, and a control wheel <NUM> having a perimeter <NUM> and configured to bend the bending section <NUM> in the way that the control wheel 10b does.

The perimeter <NUM> comprises protrusions and valleys. By perimeter <NUM> is meant the outer contour of the control wheel <NUM> in plan view. The control wheel 10a is arranged closest to the handle, whereas the control wheel <NUM> is arranged outside the control wheel 10a. The control wheel <NUM> may bend the bending section left/right and the control wheel 10a may control the bending section up/down.

<FIG> shows a typical use situation of the endoscope <NUM>, where the handle <NUM> is gripped by a left hand <NUM> of a user. A thumb <NUM> of the hand is positioned on the left/right control wheel <NUM>, whereas an index finger <NUM> is positioned on a valve <NUM> of the endoscope to control e.g. suction of the endoscope. The hand illustrated in <FIG> is relatively large and has no difficulty in controlling the valve <NUM> and the left/right control wheel <NUM> at the same time. However, a user having a smaller hand may experience difficulties in reaching the left/right control wheel <NUM>, which is positioned farthest away from the handle and further is smaller than the up/down control wheel 10a. The control wheel <NUM> is configured to overcome this problem. A first embodiment of the control wheel <NUM> is described in detail with reference to <FIG>.

A control wheel <NUM> according to the invention is shown in <FIG>. The control wheel <NUM> comprises protrusions <NUM> separated by valleys <NUM>, and a hub <NUM>. The protrusions <NUM> comprise a base part <NUM> and an extension part <NUM> connected at a turning joint <NUM>. <FIG> is a perspective view illustrating a situation where all extension parts <NUM> are in a retracted position <NUM>. In the retracted position <NUM> the extension parts <NUM> are arranged approximately parallel to the wheel rotation axis <NUM> providing a minimum extension of the protrusion <NUM> from the wheel rotation axis <NUM>, so the extension parts <NUM> are inside a circle having a radius rmin, as also illustrated in the plan view of <FIG>, which also schematically illustrates the perimeter <NUM> in dashed line. The point of protrusion <NUM> farthest away from the wheel rotation axis <NUM> is in this case at a radius rmin. Depending on the shape of the base part <NUM> and the extension part <NUM>, the point farthest away from the rotation axis <NUM> may be at the middle of the protrusion <NUM> or at one or both sides thereof. In the illustrated embodiment the point of the protrusion <NUM> farthest away from the rotation axis in <FIG> is at point 40a. A situation where all extension parts <NUM> are in an extended position <NUM> is illustrated in <FIG>. Here all extension parts <NUM> are twisted to extend approximately in radial direction from the wheel rotation axis <NUM> providing a maximum extension of the protrusion <NUM> from the wheel rotation axis <NUM>. <FIG> is a plan view corresponding to the perspective view of <FIG>, and the point of protrusion <NUM> farthest away from the wheel rotation axis <NUM> is at a radius rmax, so the perimeter <NUM> is changed compared to <FIG>. In the illustrated embodiment the point of the protrusion <NUM> farthest away from the rotation axis in <FIG> is at point 40a. <FIG> illustrate an exemplary embodiment of the turning joint <NUM>. The turning joint comprises a base part <NUM> with a joint surface 47a arranged at an angle to the rotation axis <NUM>. The angle may be e.g. <NUM> degrees. The base part <NUM> further comprises a joint keyhole 48a. The extension part <NUM> comprises a corresponding angled joint surface 47b configured to rotate on the angled joint surface 47a of the base part <NUM>. The extension part <NUM> further comprises a joint key 48b with a key projection <NUM> adapted for engaging the keyhole 48a of the base part <NUM>. Hence the base part <NUM> and the extension part <NUM> may be connected in a turning joint <NUM> with one degree of freedom by inserting the joint key 48b of the extension part <NUM> into the keyhole 48a. The key projection <NUM> can ensure that the extension part <NUM> of the turning hinge <NUM> can turn relatively to the base part <NUM>, but not disconnect (except in a special position, where the key projection <NUM> register with a corresponding opening of the keyhole 48a).

The hub <NUM> and base part <NUM> may be of unitary construction, such as made of plastic and moulded in one piece. The extension part <NUM> including the key projection <NUM> may also be moulded in one piece in a plastic material. The plastic material may be for example ABS or PP. A bioplastic material may also be used.

A second embodiment of a control wheel <NUM> according to the present disclosure is shown in <FIG>. The control wheel comprises protrusions <NUM>, valleys <NUM>, and a hub <NUM>. The protrusions <NUM> comprise a base part <NUM> and an extension part <NUM>, which are interconnected by a hinge joint <NUM>. The hinge joint <NUM> comprise a hinge tap <NUM> and hinge grippers <NUM>. <FIG> illustrate a situation where all extension parts <NUM> are in a retracted position <NUM> in that extension parts <NUM> are folded back on top of the base parts <NUM>. The extension parts <NUM> are inside a circle having a radius rmin and length of the protrusion <NUM> in radial direction from the wheel rotation axis <NUM> is minimum, as also illustrated in the plan view of <FIG>. The point of the perimeter <NUM> farthest away from the wheel rotation axis <NUM> in the illustrated embodiment of <FIG> is at point 40a.

A situation where all extension parts <NUM> are in an extended position <NUM> is illustrated in <FIG>. Here all extension parts <NUM> are folded out about the hinge joint <NUM> to extend approximately in radial direction from the wheel rotation axis <NUM> providing a maximum extension of the protrusion <NUM> from the wheel rotation axis <NUM>, as also seen in the plan view of <FIG>. The extension parts <NUM> are inside a circle having a radius rmax and length of the protrusion <NUM> in radial direction from the wheel rotation axis <NUM> is maximum, as illustrated in the plan view of <FIG>. The perimeter <NUM> of the control wheel has changed when comparing <FIG>, and the point of the perimeter <NUM> farthest away from the wheel rotation axis <NUM> in the extended position <NUM> in the illustrated embodiment of <FIG> is at point 40b.

The hinge may have a separate key, tap or shaft to turn around, which will facilitate production, as the parts can be simple. For single use it is however preferred that the endoscope is made of few parts, which facilitates assembly. Further it is advantageous that the parts are made of e.g. plastic, to facilitate mass production e.g. by moulding. By moulding it is possible to provide parts with integrated hinge elements.

An endoscope <NUM> fitted with a control wheel <NUM> according to the second embodiment illustrated in <FIG> is shown in <FIG>. The endoscope handle <NUM> is held by a user in the left hand, whereas index finger <NUM> and thumb <NUM> of right hand is used to extend one of the extension parts <NUM>. Some extension parts <NUM> are in the retracted position, whereas others are in the extended position. Left hand can operate the suction valve <NUM> and normally also the up/down control wheel rotation lock 13a, whereas the left/right control wheel rotation lock 13b generally needs to be operated by the right hand of the user.

An L-shaped extension part <NUM> according to an embodiment is shown in <FIG>, which are close-ups of protrusions similar to the protrusions <NUM> shown in <FIG>. The L-shaped extension part <NUM> is similar to the extension part <NUM> of <FIG> but comprises a projection <NUM>. <FIG> illustrate a retracted position <NUM> of the extension part <NUM>, which is folded on top of the base part <NUM>, and the projection <NUM> extends upwards in the figure. <FIG> illustrates the extended position <NUM> of the L-shaped extension part <NUM> in which the extension part <NUM> is folded out, and the projection <NUM> protrudes in axial direction downwards towards the handle (not shown). The extension part <NUM> is connected to a base part <NUM> by a hinge.

Alternative embodiments using a telescopic connection of the extension part to the base are shown in <FIG>. Of these <FIG> are partly x-ray illustrations schematically illustrating an embodiment, where the extension part <NUM> is slidably connected to the base part <NUM> via a slider <NUM> of the extension part <NUM> engaging a groove (not shown) in the interior of the base part <NUM>. The retracted position <NUM> is shown in <FIG>, whereas the extended position <NUM> is shown in <FIG>. The schematic sectional view of <FIG> illustrates an alternative telescopic connection according to another embodiment. Here the extension part <NUM> comprises a resilient leg <NUM> engaging a ratchet <NUM> inside the base part <NUM>. A further alternative telescopic connection is shown in the schematic sectional view of <FIG>. The extension part <NUM> is a telescopic spindle <NUM> having threads engaging corresponding threads of the base part <NUM>. The user may extend the extension part <NUM> by turning the extension part relatively to the base part <NUM>. Suitably the telescopic connection of the extension part is provided with an end stop to avoid disengagement of the extension part from the base part.

The endoscope may further comprise a releasable extension part lock to prevent or minimize the risk of unintentional shift between the extended position <NUM> and the retracted position <NUM>. Suggested extension part locks are schematically illustrated in <FIG>. In the example illustrated in <FIG> an extension part <NUM> is rotatably connected to base part <NUM> with a rotation axis <NUM> with the extension part <NUM> arranged inside base part <NUM>. <FIG> illustrates a retracted position <NUM> of the extension part <NUM>, whereas <FIG> illustrates an extended position <NUM> of the extension part <NUM>, which in this case is rotated to extend out of the plane of the paper. The extension part <NUM> comprises bosses <NUM>, which in the extended position <NUM> engage corresponding recesses <NUM> formed in the base part <NUM> to form an extension part lock <NUM>. An alternative extension part lock <NUM> is illustrated in <FIG>. An extension part <NUM> comprises legs <NUM> engaging corresponding openings <NUM> of a base part <NUM>. The legs <NUM> of the extension part <NUM> comprise bulbs <NUM> engaging recesses <NUM> of opening <NUM>, thereby restricting movement of the extension part <NUM> relatively to the base part <NUM>. The schematically illustrated lock <NUM> limits the risk of unintentional movement of the extension part <NUM> from the retracted position at rmin to the extended position at rmax and vice versa, as the bulbs <NUM> rest in the recesses <NUM>. <FIG> schematically illustrate an extension part lock <NUM> for a construction similar to <FIG>. The extension part lock <NUM> comprises a recess <NUM> and a corresponding boss <NUM>, which will register and lock when the extension part <NUM> is in the extended position.

Claim 1:
Endoscope (<NUM>) comprising
a proximal handle (<NUM>) or interface, and
an insertion cord (<NUM>) extending distally from the handle or interface, the insertion cord having distal bending section (<NUM>),
a control wheel (<NUM>) arranged at the handle, the control wheel having a wheel rotation axis and a perimeter (<NUM>) comprising protrusions (<NUM>) extending away from the wheel rotation axis,
the control wheel controlling bending of the bending section by rotation of the control wheel around the wheel rotation axis,
wherein at least one protrusion comprises a base part (<NUM>) and an extension part (<NUM>) wherein the extension part is connected to the base part via a turning joint (<NUM>), wherein the extension part is extendable from a retracted position (<NUM>) to an extended position (<NUM>)
characterized in that in the retracted position the extension part is arranged approximately parallel to the wheel rotation axis and in the extended position the extension part is twisted to extend approximately in a radial direction from the wheel rotation axis.