The present disclosure relates to a component to be used in 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 endotracheal tubes and insertion endoscopes are well known devices for visually inspecting body cavities, such as 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 Light Emitting Diode (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 fiber-optic, in which case the optical fibers run along inside of the elongated insertion tube to the tip part.
In order to be able to maneuver 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, 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 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 WO2014/106511, disclosing a disposable endoscope.
When the insertion tube of the endoscope is intended to be inserted into a 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.
One known way of sealing the tip part of an endoscope is disclosed in WO2010/066790. In this document a transparent monolithic housing is formed around the electronics and working channel by placing the electronics and the tube forming the working channel in a mold of transparent material, such as silicone. A transparent UV curable resin is then inserted from the bottom of the mold to avoid bubbles to form in the transparent resin. Because the resin rises slowly from the bottom, the air is slowly expelled from top of the mold, without any risk of air bubbles being trapped in the mold. The resin is then cured using UV irradiation through the transparent mold to form the monolithic housing. However, forming a monolithic housing in this way has some drawbacks. One is that it is a somewhat slow process. Another is that it can be difficult to position and maintain the components precisely in position during the insertion of the resin. Thus, the camera or LEDs may in few cases be off-set sideways or a thin transparent layer may inadvertently be created in front of the camera and/or LEDs, thereby reducing the imaging qualities of the tip part. This will lead to the product being discarded in the quality control, thereby increasing overall cost of manufacturing.
A further problem is the general transparency of the housing, which derives from that fact that the resin itself is and—needs to be, transparent in order for the UV radiation to penetrate and cure the resin. This may result in undesired stray light from the LEDs which through the transparent housing itself impinges on the sensor of the camera and may disturb the captured images.
This reflection problem is addressed in JP3-764512B. This document discloses a disposable external sleeve for the insertion tube of an insertion endoscope. The external sleeve has a tip part with a front window for the camera of the insertion endoscope. The front window of the tip part is provided with shading members through two component injection molding of a transparent window material and an opaque shading material. This is to minimize glare from the built-in light sources of sleeve to the camera of the insertion endoscope. This front window is generally just a pane with a uniform thickness apart from the shading members, and will not be well suited for an integral housing directly accommodating the components of the endoscope.
Furthermore, the materials which have good optical properties in terms of refraction index and transparency may not have good adhesion properties for e.g. sealant material, glue used for attaching outer sheaths or similar that involves adhesion.
It is a first object of the disclosure to provide a housing for a tip part of an endoscope, a tip part including such housing, and an endoscope with such a housing for the tip part which do not suffer from the above drawbacks.
According to a first aspect of the invention this object is achieved by a tip housing for the distal tip of a disposable insertion endoscope, said tip housing having a front end and a circumferential wall and comprising a first polymer material and a second polymer material where the second polymer material is transparent, said tip housing being adapted to accommodate an electronic vision device, and at least one light source, said tip housing comprising a first window part arranged in front of the electronic vision device in the field of view thereof and a second window part arranged in front of the at least one light source, wherein the first window part and the second window parts are formed as a single piece of said second polymer material, said tip housing further comprising an inwardly protruding part, where the inwardly protruding part is formed integrally with the circumferential wall as a single piece of the first polymer material and/or integrally with said first and second window parts as a single piece of the second polymer material.
According to a first embodiment according to the first aspect of the disclosure the inwardly protruding part is adapted to guide and position the electronic vision device with respect to said first window part. This is an efficient way of assuring good positioning and alignment of the electronic vision device with respect to the first window part, so as to ensure low rejection rates in the manufacture of the disposable insertion endoscopes, in turn keeping costs down.
According to a second embodiment of the first aspect of the disclosure, the at least one inwardly protruding part formed integrally with said first and second window parts as a single piece of the second polymer material comprises a light guide. By integration of the light guides in the single-piece item also comprising the first and second windows, the angular light distribution from LED light sources may readily be adapted to the field of view of the electronic vision device.
According to another embodiment according to the first aspect of the disclosure, the first housing material is opaque. This allows the introduction of shading parts inter alia reducing stray light and glare into the camera.
According to a further embodiment according to the first aspect of the disclosure, the set first material has better adhesion properties to glue than the set second material. This allow the circumferential wall of housing to adhere efficiently to a sealing glue for sealing the inner compartment, and for an outer sheath of the insertion tube of the endoscope to be securely adhered to the exterior or the interior of the circumferential wall of the pot-shape housing.
According to yet another embodiment according to the first aspect of the disclosure, at the front end of the housing, said single piece of said first polymer material partially covers said second polymer, so that the front window part and said light guide part appear as separate areas isolated from each other by said first polymer, when viewed from the distal end. This has been found to highly reduce stray light and glare from the light source(s) into the camera.
According to yet a further embodiment according to the first aspect of the disclosure, the second housing material is a thermoplastic material. This allows the tip housing to be produced in an efficient manner, such as by injection molding.
According to a second aspect of the disclosure the object is solved by a method for manufacturing a tip housing according to the first aspect of the disclosure for the distal tip of an insertion endoscope, said method comprising providing a molding tool, introducing in the molding tool a first housing material, introducing in the molding at least one second housing material different from the first housing material, allowing the at least one second housing material to set and form a combined housing component with the first molding material, removing the combined housing component from the molding tool.
This allows the provision of an integrated unit for the tip housing having different areas with different desired properties.
According to a first embodiment, the molding tool comprises a first cavity, a second cavity and a core. In particular, in injection molding this is advantageous as the molded object normally shrinks during cooling and therefore tends to stick to the core.
According to another embodiment, the first housing material is allowed to set before the at least one second housing material is introduced. This provides well defined boundaries between the two materials in the final integrated unit. Moreover, it allows the first mold to stick to the core for the introduction into the second cavity of the molding tool.
According to another embodiment, the volume of the at least one second housing material introduced in the mold is smaller than the volume of the first housing material introduced in the mold. This is in particular of advantage when the second material is more brittle than the first material, because having a smaller volume thereof will make it less prone to stick to the mold due to shrinking, thereby making it easier to extract from the mold. Therefore, the second material may also be injected at higher pressure than the first material, because a high pressure used for the first material would make it more prone to sticking to the mold and/or cores, in turn making removal more difficult.
According to a further embodiment, the at least one second housing material is selected from the group comprising thermoplastic materials, thermoset materials and elastomers. These materials render themselves for injection molding of at least the second housing material. Injection molding is efficient in terms of quick reproduction of identical items.
Accordingly, according to another embodiment, the introduction of the first and/or the second housing material forms part of an injection molding process.
According to another embodiment, the at least one second housing material comprises a transparent housing material. Injecting the transparent material as the second housing material in many cases is advantageous, because the transparent materials which are preferred for their optical properties, may then be introduced under higher pressure than the first material. This, in turn, reduces shrinking and better control of the optical properties of the final product is therefore obtained. Furthermore, because the more brittle material constitutes only a minority part of the total housing material, it is easier to remove from the mold. Accordingly, it is also preferred when the first housing material is opaque.
Albeit the first housing material could also be selected for other properties, such as good adhesion to sealant materials and adhesives. Thus, according to a further embodiment, the set first material has better adhesion properties to glue than the second material.
According to another embodiment, first cavity and the second cavity have generally cylindrical shapes. This results in a generally cylindrical tip housing which in turn is suitable for the endoscopes made with tip housing according to the present disclosure.
The disclosure will now be described in greater detail based on nonlimiting exemplary embodiments and with reference to the drawings on which:
Turning first to
In
In
The first material 11 on the other hand need not have good optical properties and may therefore be selected based on entirely different criteria.
In particular the first material may be an opaque material. This will allow stray light from e.g. the light source to be absorbed and not disturb the images captured by the vision receptor, be it a video camera, an imaging chip, or an optical fiber. If opacity is the only desire, the first material 11 may essentially be the same as the second material 12, i.e. the same plastic material with a filler or a dye to make it opaque. This ensures that the first and second materials are very compatible, allowing them to bond well together and ensure a water and air tight housing part 5.
Also, the first material 11 may also be chosen for good adhesion properties to other materials, e.g. other parts of the endoscope 1. Such good adhesion properties could be good bonding to sealant materials, used for sealing the proximal end of the housing, e.g. around the lead-in 13 for electrical cables to the electronics section 9, to prevent ingress of water and other pollutants that could potentially harm the electronics section 9. Also, good bonding to an adhesive used for attaching the external sleeve around the bending section is advantageous.
Furthermore, the first material may be soft at least compared to the second material. In particular, it may be so soft that rather than attaching a sleeve to it, it may itself form a sleeve for the articulated bending section 4 to which it is attached as the most distal segment. Furthermore, this would facilitate or enable demolding of undercut features inside the housing because the material may deform elastically.
Evidently, there are numerous other design choices that come into play for the selection of the most suitable material for the first material 11, provided of course that no further materials are used. The latter is, however, far from excluded by the present disclosure. Thus, if for the attachment of the tubular member 6 a number of spring like protrusions 14 are provided for holding the end of the tubular member 6, the material should be resilient enough to provide sufficient holding force, but of course with suitable adhesive properties, the tubular member could also be glued to the inside of the protrusions 14 or a similar receptacle.
To achieve good tightness between the first material 11 and the second material 12 they are according to the disclosure molded together to form one integrated unit. A molding process for this will be described below with reference to
Turning first to
The core 16 with the first material stuck to it is then used as a what is effectively a new core in a second generally cylindrical mold cavity 17 forming as second configuration of the molding tool, as can be seen in the cross-sections of
This remaining cavity can now be filled with the hot liquefied second material 12 which fuses with the first material 11 when it solidifies and forms an integral unit as the housing part 5. As described above in conjunction with the first material this may be a hot liquefied injection with subsequent cooling if the second material is a thermoplastic material or a cold injection with subsequent heating if the second material is a thermosetting material. Since this part formed from the second material 12 is located in front of the light source(s) and the vision receptor, be it a video camera, an imaging chip, or an optical fiber it is important to also ensure good optical properties of the finished part. Thus, the second material 12 is preferably injected under high pressure to ensure good filling of the cavity 17 without internal bubbles, and with sustained high pressure under the solidifying stage to avoid shrinking, which could deteriorate smoothness of the front surface and cause internal cavities. Furthermore, apart from the optical advantages gained form injecting the transparent second material 12 last, injecting this second material which will normally have a smaller volume is advantageous. This allows the above mentioned injection at higher pressures because the smaller volume decreases the risk of the shrinking material sticking to the core and/or molds, even if additional material is injected to compensate for the shrinking.
After the second material 12 has finished solidifying, the housing part 5 comprising the bonded together first and second materials 11, 12 still sticks to the core 16 and may be removed from the second molding cavity 17 with it, when the molding tool is opened by retracting the core 16. The finished housing part 5 may then be separated from the core 16 in a conventional manner by means of ejectors in the core 16 or in any other suitable manner, e.g. using a robot.
The molding tool may preferably comprise two identical cores for one set of first and second cavities. With a suitable alternation arrangement, e.g. a revolver, one core 16 may be used in the first molding cavity while simultaneously the other core 16 with the solidified first material 11 thereon is used in the second molding cavity and subsequently vice versa in an alternating manner. This arrangement may of course be multiplied with more sets of first and second cavities in sequence and a corresponding number of cores used in these cavities in one after the other.
The layout of the first and second molding cavities 15, 17 and the core 16 may differ from the illustrated embodiment resulting in a different housing part 10 for the tip part 5. Thus, either or both of first material and second material 12 could extend longer in the lengthwise direction i.e. from distal end towards proximal end. The layout of an opaque material could be shaped specifically to the output of the light sources. Likewise, the layout of the transparent material could be shaped specifically to the light sources. As best seen in
As can be seen from
More specifically the layout of the first and second molding cavities 15, 17 and the core 16 could be laid out to provide a housing part 10 as illustrated in
Accordingly, in
More specifically, this has in the embodiment of
Furthermore, even though the description above has been given for sequential molding it is not excluded that the housing part may be molded in a co-injection process where the first and second housing materials are introduced e.g. simultaneously into a single molding cavity through different inlets. This will allow control to be maintained over the location of the different materials without having to open, modify and reclose the mold, i.e. moving the cores 16 with respect to the molding cavities 15, 17.
With the housing part provided as an integral unit comprising two different materials it becomes possible to optimize the housing part for more than one parameter, e.g. for transparency vs. opacity, transparency vs. adhesion, brittleness vs. toughness, etc. The integral unit may be provided by other methods than the one described above. In particular, if injection molding is used, an opposite arrangement could be used, i.e. a single molding cavity, and two different cores inserted sequentially in that single molding cavity, the first molded part then remaining in the cavity when the second core is inserted. Analogous to the above, a number of identical cavities could then be used.
The following items are embodiments originally claimed:
Item 1. A tip housing for a distal tip of a disposable insertion endoscope, said tip housing having a front end, a circumferential wall, and comprising a first polymer material and a second polymer material where the second polymer material is transparent, said tip housing being adapted to accommodate an electronic vision device, and at least one light source, said tip housing comprising a first window part arranged in front of the electronic vision device in the field of view thereof and a second window part arranged in front of the at least one light source, wherein the first window part and the second window parts are formed as a single piece of said second polymer material, said tip housing further comprising at least one inwardly protruding part, where the at least one inwardly protruding part is formed integrally with the circumferential wall as a single piece of the first polymer material and/or integrally with said first and second window parts as a single piece of the second polymer material.
Item 2. The tip housing of item 1, wherein the inwardly protruding part is adapted to guide and position the electronic vision device with respect to said first window part.
Item 3. The tip housing of item 1, wherein the at least one inwardly protruding part formed integrally with said first and second window parts as a single piece of the second polymer material comprises a light guide.
Item 4. The tip housing of item 1, wherein the first housing material is opaque.
Item 5. The tip housing of any of the preceding items, wherein the set first material has better adhesion properties to glue than the set second material.
Item 6. The tip housing of item 1, wherein, at the front end said single piece of said first polymer material partially covers said second polymer, so that the front window part and said light guide part appear as separate areas isolated from each other by said first polymer, when viewed from the distal end.
Item 7. The tip housing of item 1, wherein the second housing material is a thermoplastic material.
Item 8. A disposable insertion endoscope comprising a tip housing according to item 1.
Item 9. A method for manufacturing a tip housing according to item 1 for the distal tip of an insertion endoscope, said method comprising: providing a molding tool; introducing in the molding tool a first housing material; introducing in the molding at least one second housing material different from the first housing material; allowing the at least one second housing material to set and form a combined housing component with the first molding material; and removing the combined housing component from the molding tool.
Item 10. The method of item 9, wherein the molding tool comprises a first mold cavity, a second mold cavity and a core.
Item 11. The method of item 9, wherein the first housing material is allowed to set before the at least one second housing material is introduced.
Item 12. The method of item 9, wherein the volume of the at least one second housing material introduced in the mold is smaller than the volume of the first housing material introduced in the mold.
Item 13. The method of item 9, wherein the at least one second housing material is selected from the group comprising thermoplastic materials, thermoset materials, and elastomers.
Item 14. The method of item 9, wherein the at least one second housing material comprises the transparent housing material.
Item 15. The method of item 9, wherein the first cavity and the second cavity have generally cylindrical shapes.
Item 16. The method of item 9 wherein the introduction of the first and/or the second housing material forms part of an injection molding process.
Number | Date | Country | Kind |
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18161746 | Mar 2018 | EP | regional |
18161752 | Mar 2018 | EP | regional |
18161762 | Mar 2018 | EP | regional |
19161893 | Mar 2019 | EP | regional |
19161898 | Mar 2019 | EP | regional |
19161907 | Mar 2019 | EP | regional |
This patent application is a divisional of U.S. patent application Ser. No. 16/352,437, filed Mar. 13, 2019, which claims priority to and the benefit of European Patent Applications Nos. 18161752 and 18161762, entitled A TIP PART FOR A VISION DEVICE, filed on Mar. 14, 2018, of European Patent Application No. 18161746, entitled METHOD FOR MANUFACTURING A TIP HOUSING, filed on Mar. 14, 2018, of European Patent Application No. 19161898, entitled A TIP PART FOR A VISION DEVICE, filed on Mar. 11, 2019, of European Patent Application No. 19161907, entitled A TIP PART FOR AN INSERTABLE VISION DEVICE, filed on Mar. 11, 2019, and of European Patent Application No. 19161893, entitled METHOD FOR MANUFACTURING A POT-SHAPED TIP HOUSING, filed on Mar. 11, 2019, respectively, all of which are incorporated by reference herein in their entirety.
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