This application claims priority from and the benefit of European Patent Application No. EP21179543, filed Jun. 15, 2021, which application is incorporated herein by reference in its entirety.
The disclosure relates to insertable medical vision devices, in particular disposable insertion endoscopes, and more specifically to a housing for the tip of the disposable insertion endoscope and the manufacture thereof.
Vision devices, such as insertion endoscopes, are well known devices for visually inspecting body cavities, such as human body cavities. Typically, an insertion endoscope comprises an elongated insertion tube with a handle at the proximal end as seen from the operator and visual inspections means, such as a built-in camera, at the distal end of the elongated insertion tube. Electrical wiring for the camera and other electronics such as LED lighting accommodated in the tip part at the distal end run along the inside of the elongated insertion tube from the handle to the tip part. Instead of using cameras, endoscopes may also be fibre-optic, in which case the optical fibres run along inside of the elongated insertion tube to the tip part.
In order to be able to manoeuvre the endoscope inside the body cavity, the distal end of the endoscope may comprise a bending section with increased flexibility, e.g. a number of articulated segments of which the tip part forms the distalmost segment. This is typically done by tensioning or slacking pull wires also running along the inside of the elongated insertion tube from the tip part through the remainder of articulated segments to a control mechanism of the handle. Furthermore, a working channel may run along the inside of the insertion tube from the handle to the tip part, e.g. allowing liquid to be removed from the body cavity or allowing the insertion of surgical instruments or the like into the body cavity.
As the name indicates, endoscopes, are used for seeing inside things, such as lungs or other human body cavities of a patient. Modern endoscopes are therefore typically equipped with a least one camera or similar image capturing device at the distal tip of the endoscope. Provided that sufficient light is present, this allows the operator to see where the endoscope is steered and to set the target of interest once the tip has been advanced thereto. This therefore normally requires illumination of the area in front of the distal tip of the endoscope, in particular the field of vision of the camera(s). One known way of achieving such illumination is to provide the above mentioned LED lighting using one or more Light Emitting Diodes (LEDs) in the tip of the endoscope, as e.g. mentioned in commonly-owned U.S. Pat. No. 10,321,804, disclosing a disposable endoscope.
When, as according to the present disclosure, the insertion tube of the endoscope is intended to be inserted into a human body cavity, the insertion tube needs to be sealed in a watertight manner. This is in particular the case for the distal tip part because it accommodates the camera, LED(s) and other delicate electronics, prone to malfunction or destruction if exposed to humidity. Also, there are electrical requirements to ensure that the electrical insulation of the endoscope is not compromised e.g. by electrical breakdown of the polymer material from which disposable endoscopes are typically made.
Furthermore, it is desirable to provide the front window of the tip part with shading members through two-stage two-component injection moulding of a transparent window material and an opaque shading material. This is to minimize glare from the built-in light sources to the camera of the insertion endoscope. One such tip part and manufacturing method is known from commonly-owned U.S. Pat. No. 11,291,352, which is incorporated herein by reference.
While the tip housing in accordance with U.S. Pat. No. 11,291,352 has shown to generally fulfil the above requirements, the joining of the two materials is not always optimal, inter alia because the interface between the transparent part, as seen from the distal end surface of the tip part, is formed only within the essentially cylindrical side wall of the housing away from the end wall, so that the area of the interface where the two materials bond together corresponds to the relatively thin housing side wall. This may have the effect that the electrical insulation becomes sub-standard, in turn leading to rejects during subsequent testing of the endoscopes, in turn, causing unnecessary costs. It furthermore, provides only a limited area for the two materials to fuse together and provide the necessary mechanical strength between the materials.
Based on this prior art it is an object of the invention to provide an endoscope with an improved housing for the tip part which does not suffer from the above drawbacks.
According to a first aspect of the disclosure, this object is achieved by an endoscope with a distal tip part comprising a tip housing integrally moulded from a first material and a second material that is transparent. The tip housing has an end wall formed from the first material and the second material, and in the end wall the second material at least in part overlaps the first material. The tip housing can be moulded in a two step injection moulding process that yields a one-piece integrally moulded part.
In some embodiments, said housing comprises the end wall and a surrounding side wall with an internal end wall surface and an internal side wall surface so as to define at least one inner compartment accommodating an electronic vision device and at least one light source, where the end wall comprises an external end surface facing the exterior of the housing and the surrounding side wall comprises an external surrounding side surface facing the exterior of the housing, where the second material is provided as a part of the end wall so as to provide a vision window in the end wall covering the electronic vision device and a light emission window adapted to receive and transmit light from the at least one light source through the end wall, wherein, in the end wall, said second material overlaps at least partially said first material when viewed from the exterior towards the external end surface.
By creating such an overlap, the area over which the first and second materials contact each other and fuse together is increased, thus better ensuring proper fusion of the two materials. Furthermore, the distance along the fusion seam from the inside to the outside is increased, in turn, leading to a longer electrical paths, should defects in the fusion exist, hence further decreasing the risk of electrical breakdown.
According to a second aspect of the disclosure the object is achieved by a method in manufacturing an endoscope according to any one of the preceding claims wherein the tip is injection moulded in a two-stage injection moulding process in which, in the first stage, the first material is injected into a mould through a first single gate and in which, in the second stage said second material overlap is injected through a second single gate. Such method allows a cost-efficient way of manufacturing in particular the tip part of the endoscope.
According to a third aspect of the disclosure, the object is achieved by a system comprising a display device and an endoscope according to the first aspect of the disclosure connectable to the display device. In such a system the use of an endoscope according to the first aspect reduces the risk of electrical breakdown induced via the electrical connection between the endoscope and display device.
According to an embodiment of the first aspect of the disclosure, the second material is provided as one contiguous part so as to provide both said vision window and said light emission window. This allows the injection of the transparent material through a single gate only, during the injection moulding process.
According to an embodiment according to the first aspect of the disclosure, the second material is provided as one contiguous part providing part of the side wall and part of the end wall. This allows the moulding gate of the mould to be placed at a location away from front window so as to minimize any disturbance of the optical properties that may be caused by the moulding process.
According to an embodiment according to the first aspect of the disclosure, the overlap is formed as a step between the first and second materials. Using a step further increase the distance from the inside to the outside along the fusion seam and may provide large interface areas where the first and second material fuse together.
According to another embodiment according to the first aspect of the disclosure, the step comprises a first interface extending below and in parallel with the end surface. Having the interface extending below the end surface, increases the mechanical resistance of the fusion seam as the main forces acting on the end surface during insertion of the endoscope will be perpendicular to the interface.
According to a further embodiment of the first aspect of the disclosure, the step comprises a second interface extending essentially at a right angle to said first interface. This increased the area of the overall interface between the first and second material and further strengthens the fusion seam against shear forces.
According to a further embodiment of the first aspect of the disclosure, said overlap is arranged at a central part of the end surface away from the surrounding side wall when viewed from said end surface. This allows the enlarged interface are to be located in a place where it does not disturb other features, and hence allows for a relatively large and strong interface between the first and second materials.
According to a further embodiment according to the first aspect of the disclosure, the second material overlaps a moulding artefact in the first material. Thereby, moulding artefacts, such as defects and remnants from the gate of the first molding stage may be covered, in turn, providing the end wall with a smooth surface on which nothing may get caught and which is better at repelling residue that may block the vision or illumination.
According to yet another embodiment according to the first aspect of the disclosure, the tip is injection moulded in a two-stage injection moulding process in which, in the first stage, the first material is injected into a mould through a first single gate and in which, in the second stage said second material overlap is injected through a second single gate.
According to yet a further embodiment according to the first aspect of the disclosure, the second gate is arranged in conjunction with the side surface of the tip housing. That is to say at a location on the side surface, so that any residue from broken off runners at the gate will end be present on the side surface. This allows proper flow of the second material from the second gate into the front window part and the light guides which are preferably arranged mirror-symmetrical on either side of the central vision window, ensuring good filling and hence good optical properties, inter alia by keeping the single gate away from the front window surfaces.
According to still another preferred embodiment, the first gate is arranged in conjunction with the interface. That is to say at a location in the interface, so that any residue from broken off runners at the gate will end be present in the interface rather than on the outer surface of the housing. This allows central filling and good flow from a single gate that may later be covered by the second material injected elsewhere.
According to a fourth aspect of the disclosure, a method of making an endoscope is provided, the method comprising: injection moulding a tip housing comprising, after said injection moulding, an end wall and a surrounding side wall so as to define at least one inner compartment configured to accommodate an electronic vision device and at least one light source, the end wall comprising an end surface and the surrounding side wall comprising a side surface, the end wall and the side wall integrally moulded from a first material and a second material, the second material being a transparent material, wherein said injection moulding comprises, in a first stage, injecting the first material into a mould through a first single gate and, in a second stage, injecting the second material through a second single gate, and wherein, in the end wall, the second material overlaps at least partially the first material when viewed from the end surface.
The disclosure will now be made in greater detail based on non-limiting exemplary embodiments and with reference to the drawings on which:
The present disclosure may be further understood with reference to the following description and appended drawings, wherein like elements are referred to with the same reference numerals.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are illustrated below, although apparatuses, methods, and materials similar or equivalent to those illustrated herein may be used in practice or testing. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.
The terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional terms that do not preclude the possibility of additional acts or structures. By contrast, the term “consists,” as used herein, is intended to be a closed-ended transitional term that precludes the possibility of additional acts or structures.
The term “distal,” as used herein, refers to a direction or position that is generally towards a target site, and the term “proximal,” as used herein, refers to a direction or position that is generally away from the target site.
Turning first to
The endoscope 2 in the illustrated example comprises a proximal handle 5 adapted to be gripped by a hand of an operator. From the handle 5 an insertion cord 6 extends towards the distal end of the endoscope 2. The insertion cord 6 comprises an insertion tube 6a and a bending section 6b extending therefrom. At the distal end of the endoscope 2 the insertion cord 6 includes a tip housing 7, typically constituting the most distal end of the endoscope 2. The focus of the present disclosure is on the tip housing 7, as illustrated in the subsequent figures, and the skilled person will understand that the remainder of the endoscope 2 may have a different design without deviating from the essence of the disclosure.
In one variation, shown in
In another variation, shown in
Both variations of the VPA may perform the same video processing functions. The processed video can be presented with a separate display device communicatively connected, via a wired or wireless connection, with the VPA 3, 3a, 3g. This enables placement of the display screen in a location distinct from the location of the VPA 3, 3a, 3g. This also enables use of a display device available in the operating room for other purposes.
A position interface functions to control the position of the insertion cord 6. The handle 4 is an example of a position interface and, unless stated otherwise, the terms are used interchangeably. The handle also functions to provide manual control actuators, e.g. knobs, levers, buttons, and the like, to steer the housing 7 and control instruments guided through the insertion cord. Alternatively, a different position interface can be provided that is connected to the insertion cord and is detachably connected to a robotic arm. The insertion cord thus extends from the robotic arm, and the endoscope is thus detachable from the robotic arm. The housing 7 is the same regardless of the position interface used. The robotic arm responds to signals, such as voice commands from the operator, to rotate, translate, and otherwise position the proximal end of the insertion cord, as an operator would do manually. The position interface can include control actuators, including manual control actuators. Alternatively or additionally, control actuators can be provided in or on the robotic arm or by the robotic system including the robotic arm, thereby potentially reducing the cost of the endoscope. Example control actuators include single axis actuators, including linear motion actuators. A linear motion actuator may comprise a threaded rod coupled to a threaded nut portion, in which a motor rotates the rod to translate the nut portion.
In
The housing 7 comprises an end wall 10 and a surrounding side wall 11 so as to define at least one inner compartment 12, best seen in
As can best be seen from
The end wall 10 may comprise additional features provided with the first housing part 8 such as a spray nozzle 16 and a working channel exit port 17 where the spray nozzle is adapted to spray water onto the vision window 13 and/or the light emission windows 14.
Towards the proximal end of the housing 7 the first housing part 8 may have a slightly recessed portion 18 to allow the bending section 6 to overlap the housing 7 and form a good connection when assembling the endoscope 2. On top of both the housing 7 and the bending section 6 an outer sleeve or covering is normally fitted, in order to avoid undesired fluid ingress into the bending section 6, which is normally a relatively open articulated structure.
Turning now to
Similarly, i.e. for the same reasons, the passage 21 for light into the vision device may also be widened towards the end surface 10, preferably also in a stepwise manner providing an essentially plane surface 22 adjacent the through passage 21. The plane surface 22 is preferably also arranged to be parallel to the final end surface 10 of the finished housing 7. Furthermore, the plane surface 22 may be at least partially surrounded by a wall 29 perpendicular to the plane surface 22, hence forming the riser of the step. This surrounding wall 29 forms a second interface further increases the area and thus the mechanical strength of the overall interface between the first and second materials, in particular against shear forces.
As can be seen the essentially plane surface 22 may comprise a defect in the form of remnants 23 of the gate 24 (cf.
The contiguous transparent material may also form part of the side wall, overlapping in a similar stepwise manner a preferably curved surface 30 forming a further interface between the first and second materials.
As will be further explained below and seen from
Turning now to
In
Because the two single gates 24 and 25 are in different locations the second material may smoothly cover any remnants of the first gate of the mould part 27a in the finished housing 7.
The following items are examples of various embodiments of devices disclosed above:
1. An endoscope with a distal tip part comprising a tip housing integrally moulded from a first material and a second material, the second material being a transparent material, said housing comprising an end wall and a surrounding side wall so as to define at least one inner compartment accommodating an electronic vision device and at least one light source, where the end wall comprises an end surface and the surrounding side wall comprises a surrounding side surface, where the second material is provided as a part of the end wall so as to provide a vision window in the end wall covering the electronic vision device and a light emission window adapted to receive and transmit light from the at least one light source through the end wall, wherein, in the end wall, said second material overlaps at least partially said first material when viewed from the end surface.
2. An endoscope according to item 1, wherein the second material is provided as one contiguous part providing part of the side wall and part of the end wall.
3. An endoscope according to item 1 or 2, wherein the overlap is formed as a step between the first and second materials.
4. An endoscope according to item 1 or 2, wherein the step comprises an interface extending below and in parallel with the end surface.
5. An endoscope according to anyone of the preceding claims wherein said second material overlaps a moulding artefact in the first material.
6. An endoscope according to any one of the preceding items wherein the tip is injection moulded in a two stage injection moulding process in which, in the first stage, the first material is injected into a mould through a first single inlet and in which, in the second stage said second material overlap is injected through a second single inlet.
7. An endoscope according to any one of items 5 or 6, wherein said second material overlaps the location of said first inlet.
8. An endoscope according to item 6 or 7, wherein the second inlet is arranged in conjunction with the side surface of the tip housing.
9. An endoscope according to any one of claims 5 to 8 when dependent on claim 4, wherein the first inlet is arranged in conjunction with the interface.
10. An endoscope according to any one of the preceding claims, wherein the light emission window comprises a light guide.
11. A system comprising a display device and an endoscope according to any one of items 1 to 10 connectable to the display device.
Number | Date | Country | Kind |
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21179543.0 | Jun 2021 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2022/066297 | 6/15/2022 | WO |