This application is a National Stage entry under 35 U.S.C. § 371 of International Application No. PCT/EP2020/058932, filed Mar. 30, 2020, which claims the benefit of and priority from European Application No. 19166789.8, filed Apr. 2, 2019; said applications are incorporated by reference herein in their entirety.
The present invention relates to endoscopes, in particular disposable insertion endoscopes, and more specifically but not exclusively to a housing of an insertion endoscope.
Endoscopes which in this context comprises endotracheal tubes provided with a camera as well as laryngoscopes provided with a camera, are well known devices for visually inspecting inaccessible places such as human body cavities. Endoscopes include insertion endoscopes and capsule endoscopes. Capsule endoscopes are capsules which are normally administered orally and pass through the digestive system. Insertion endoscopes on the other hand are inserted into the body via suitable openings, be it natural or purpose-provided. Insertion endoscopes typically comprise 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.
Modern endoscopes are 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, as in the present invention, 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.
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 mould of transparent material, such as silicone. A transparent UV curable resin is then injected from the bottom of the mould 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 mould, without any risk of air bubbles being trapped in the mould. The resin is then cured using UV irradiation through the transparent mould 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 injection 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.
Alternatively, a generally cup-shaped housing with an at least partially transparent bottom forming front wall at the distal end of the endoscope could be used. Partially transparent in this context is to be understood as transparent in some areas and opaque in others. In this case the transparent parts form a front window in front of the camera and light sources, such as LEDs, accommodated in the cup-shaped housing.
The transparent front window or the inadvertently created thin layer of transparent material may result in undesired stray light from the LEDs which through the transparent housing itself is reflected back from the front surface thereof because of the change in refractive index to the surroundings. This reflected light may impinge on the sensor of the camera and thereby disturb the captured images.
In this respect it is known from US2015/0289751 to chemically provide a nano-particle structure on a polymer surface in conjunction with a laparoscope.
The inventors have realized that in the context of disposable insertion endoscopes these problems may be overcome by the use of nano-structuring, even though the very fine and hence delicate nano-structuring is highly prone to damage, deterioration or destruction from external mechanical influence. This, however, turns out not to be a problem because the endoscope is to be disposed of after use with one patient, rather than having to go through a rather harsh cleaning and sterilisation procedure.
Thus, according to a first aspect of the present invention the problems is thus solved by providing a housing for the tip of a disposable insertion endoscope, said housing comprising a circumferential side wall having a first end and a second end, and a front wall arranged at the first end of said circumferential side wall, so as to provide an internal compartment in said housing, said front wall comprising at least one transparent part made of a polymer material and adapted to protect a camera arranged in said housing behind said at least one transparent part, said at least one transparent part comprising a first inner surface facing the internal compartment and a second surface opposite the first inner surface, wherein said second surface comprises at least one area provided with a nano-structure formed directly in said second surface.
Providing the nano-structure directly in the transparent polymer material furthermore obviates the risk of fragments of a separate coating detaching from the front surface, and thus the risk of potential exposure of the patient to such fragments.
According to a second aspect of the present invention, the problem is solved by a method for providing a housing according to the first aspect of the invention, said method comprising providing a mould cavity having a bottom and a circumferential wall, forming in said mould cavity a housing comprising a circumferential side wall having a first end and a second end, and a front wall arranged at the first end of said circumferential side wall, so as to provide an internal compartment in said housing, wherein at least a part of said front wall part is made from a transparent polymer material, where said at least one front wall part comprises a first inner surface facing the internal compartment and a second surface opposite the first inner surface, and providing a nano-structure directly in said transparent polymer material.
According to a third aspect of the invention, the problem is solved by a disposable insertion endoscope comprising a housing according to the first aspect of the invention.
Providing the nano-structure directly in the transparent polymer material furthermore avoid the risk of fragments of a separate coating detaching from the front surface, and thus the risk of potential exposure of the patient to such fragments.
According to a first preferred embodiment of the first aspect of the invention, the nano-structure comprises features extending perpendicular to the second surface, said features comprising one or more features selected from the group comprising peaks, ridges, ribs, pits, valleys and trenches.
Such structures are relatively easy to provide during manufacture and may by suitable selection allowing for anti-reflection properties and/or for either hydrophile or hydrophobic properties. The hydrophobic properties allow self-cleaning of the surface, and will also facilitate more efficient cleaning of a front window of the endoscope when the endoscope is provided with a cleaning nozzle for removing dirt or mucous by a water or air flow.
According to another preferred embodiment of the first aspect of the invention, the features comprise peaks with a spacing from one peak to the closest adjacent peak of less than 380 nm, preferably in the range of 200 nm to 300 nm. Spacings in these ranges are below visible wavelengths of light and will not, except for the desired anti reflection properties, interfere with the light transmission properties as such.
According to yet another preferred embodiment of the first aspect of the invention, the features comprise peaks with a spacing from one peak to the closest adjacent peak of less than 30 μm, preferably in the range of 50 nm to 30 μm. Peaks with spacings in these ranges will provide the front with hydrophobic properties, allowing the tip of the endoscope to be self-cleaning, e.g. under its own motion, be it with or without the presence of liquids in a body cavity. Cleaning by water from a nozzle will also be easier. Such water nozzles for cleaning a front window are often applied in gastroscopes or colonoscopes.
According to a further preferred embodiment of the first aspect of the invention, the nano-structure in said at least one area is provided according to a predetermined pattern. Predetermined patterns in the at least one area have been found to exhibit better properties, in particular in terms of anti-reflection over random nano-structures, i.e. random distribution of the features.
According, to yet another preferred embodiment of the first aspect of the invention, the features, the spacing, the pattern and/or combinations thereof are adapted to provide both hydrophobic and anti-reflective properties. Dual purpose can thus be achieved in one and the same housing, and in one single manufacturing stage.
According to a first preferred embodiment of the method of the second aspect of the invention, the nano-structure is provided directly in said transparent polymer material in a stamping process. Stamping of the nano-structure into the polymer requires less investment in the manufacturing process than the provision of a complementary nano-structure in a moulding cavity. This thus renders itself for small series, or variations in the patterning of the front wall of the tip housings of otherwise identical endoscopes.
According to a further preferred embodiment of the second aspect of the invention, said moulding cavity comprises a complementary nano-structure, so as to provide said nano-structure directly in said transparent polymer material in the moulding process. This allows the nano-structure to be provided directly during the moulding process, thus obviating an additional handling step for providing the nano-structure.
The invention will now be described in greater detail based on non-limiting exemplary embodiments and the drawings on which:
Turning first to
In the inner compartment 4 a camera assembly is accommodated. In the illustrated embodiment the camera assembly comprises a carrier 7, a flexible circuit board 8 with auxiliary electronic components 9 between a camera 10 and connection means 11, such as solder, for electrical wiring (not shown) to the outside of the endoscope 22. The camera assembly may incorporate a lens 12, be it as a separate item or as an integral part or the camera 10. The skilled person will understand that, conversely, the at least one transparent part forming the front wall 3 may constitute a part of the camera, in particular the front lens of the camera accommodated in the housing 1. The camera assembly including the carrier is adapted to be inserted into the housing 1 and abut the inside surface 13 of the front wall 3 in firm engagement in order to avoid air filled gaps that may increase the risk of light reflections into the camera.
In order to provide light for the camera to see with an illumination device is likewise provided in firm abutting engagement with the inside surface 13 of the front wall 3. In the illustrated embodiment the illumination device 14 is an optical fibre through which light if fed from a remote light source providing light in the visible spectrum i.e. wavelengths above 380 nm. However, LEDs abutting the inside surface of the front wall 3 and supplied through electrical wiring from a remote power source would also be an option. This light should also be in the visible spectrum above 380 nm wavelength.
As indicated above one of the problems solved by the present invention is the glare and reflections in the transparent material of the front wall 3. That is to say because of the differences in refractive indices between the transparent material of the front wall 3 and the media in front of and behind the inner surface 13 and the front surface 15, respectively, thereof, reflections will normally occur. That is to say light emitted from the distal end of the illumination device 14 at the inner surface 13 may be reflected back from the front surface 15 into the camera, without ever exiting in front of the tip of the endoscope 22 where it is intended and needed for illumination of objects of interest. If no measures are taken the reflection in such an interface, i.e. the front surface can be as high as 4%, depending of course on refractive indices of the media on either side of the interface. This is a particular problem in the tips of endoscopes, because the lateral distance between the illumination device 14 and the camera 10 is very small. In some disposable endoscopes, the diameter of the tip may be 5 mm or less or even 3 mm or less leaving only substantially less than 1 mm between the output aperture of the illumination device 14 and the input aperture of the camera 10. With a preferred thickness of 0.4 mm or more the front wall 3 for strength reasons, it does not take many internal reflections within the front wall 3 before stray light enter the camera 10, and it is therefore important to reduce the percentage of reflected light in each of these reflections.
To inter alia avoid this glare stemming from these reflections one or both of the inner surface 13 and the front surface 15, but preferably only the latter, have according to the invention been provided with one or more areas 16 and 17 having a nano-structure 18, as will be exemplified and explained with reference to
However, providing a nano-structure 18 on the outside surface may also provide the front surface with hydrophobic properties and introduce self-cleaning effects by liquids running off the surface under the motions of the tip. Also, hydrophobic properties will make active cleaning by flow of e.g. water from a nearby nozzle more efficient.
Turning now to
As can be seen in
Often, however, peaks in the shape of cones are preferred. These are preferably arranged in hexagonal patterns as illustrated in
The distance d will depend on the properties desired for the front surface 15. If only hydrophobic properties are desired of the spacing d from one peak to the closest adjacent peak should preferably be less than 30 μm, preferably in the range from 50 nm to 30 μm.
If instead, or additionally, anti-glare properties are desired, the spacing d between the features should be less than wavelengths of visible light in order not to disturb light transmission through the front surface 15 if the nano-structure 18 is present in the field of view of the camera 10. Thus, the spacing d between the features is preferably less than 380 nm, preferably in the range from 200 nm to 300 nm.
The height of the features will typically be approximately the same as the spacing d between them, or at least in the same order of magnitude, e.g. a height in the range of ½d to 2d, i.e. half to twice the spacing d.
Preferably, nano-structures 18 are only present on the transparent parts of the housing 1, i.e. the front 3. Only in the transparent parts is the need for anti-glare and self-cleaning imminent, and providing nano-structures 18 in other areas of the housing 1 is considered unnecessarily difficult. This is in particular the case when the housing is a two-component moulded tip, e.g. molded integrally from a transparent and a non-transparent material in one single moulding process, where it can be difficult to provide nano-structure 18 to both materials of a two-component molded part. This, however does not exclude that different types of nanostructures 18 are provided at the distal front of the tip. Thus, the above-mentioned nano-structures 18 with the spacing d less than 380 nm, e.g. in the range from 200 nm to 300 nm between the features 19, 20, 21, could be used in the area of the front surface 15 in front of the camera 10 and/or in front of the illumination device 14. The remainder of the front surface 15 could then be covered with nanostructures providing good self-cleaning properties, i.e. where the spacing d from one peak to the closest adjacent peak is less than 30 μm, preferably in the range from 50 nm to 30 μm in order to provide hydrophobic properties. A hydrophobic structure next to the camera window may reduce the risk of something sticking there and also blocking part of the image field of view.
It should be noted that under certain circumstances it is in fact possible to superpose two different nano-structures 18. That is to say if the spacing d, the features and/or the pattern characterizing the anti-glare properties and the spacing d, the features and/or the pattern characterizing the hydrophobic properties differ sufficient to not disturb each other they can be provided in the same area. If, as an example, the hexagonal structure of
It is currently preferred to only provide nano-structure 18 on the external surfaces. That is to say, even if, as illustrated, nano-structures 18 may be provided in an area 16 on the inner surface 13, this is not necessarily desirable. Not only are they more difficult to provide, but experiments have indicated that in fact they do not provide the beneficial anti-glare desired. The self-cleaning properties are evidently not a matter of concern in areas that liquids and contaminants should not reach in a disposable insertion endoscope 22.
The nano-structure 18 is preferably provided directly in a moulding process, but may be provided later in a stamping process, e.g. by heating the polymer material to make it soft plastic again and stamping it with a suitably nano-structured stamp. In either case the nano-structure is ready to use and does not require any further treatment, such as additional anti-glare coatings or hydrophobic coatings.
As to the manufacturing process the housing 1 is preferably made by injection moulding of one or more suitable polymer material. That is to say the entire housing may be manufactured by injection moulding using a single transparent material injected into a single mould cavity with an external shape matching the desired exterior of the housing. That is to say, the housing 1 will comprise a circumferential wall and a bottom formed integrally as a single piece from one and the same material. For a generally cup-shaped housing 1, as illustrated in
To provide the nano-structure 18 the bottom of the mould cavity is preferably lined with an interchangeable prefabricated shim with engraved, etched or otherwise imprinted with a negative of the desired nano-structure. An example of a process for making such a shim, and a corresponding nano-structure, is disclosed in the document “Injection moulding of antireflective nanostructures”, Christensen, A. B. et al, DTU Orbit, 2013, available from URL: <http://orbit.dtu.dk/files/97131108/AlexanderBC_MNE2013 poster.pdf>. In this document a master pattern corresponding to the desired nano-structure is etched in black silicon. A nickel shim is then provided by electroplating the black silicon. The nickel shim subsequently coated with an anti-stick coating. The coated nickel shim is placed in a mould and an item with an anti-reflective surface is then injection moulded from a black polymer. The suggestion is made that this may be useful for replacing anti-reflective coatings for camera objectives and other glass items. How this is to be done, and how to proceed from an opaque black polymer towards replacement of transparent lens coatings is not disclosed. A nano-structure for a stamp could be prepared as a shim in a similar manner.
The transparent material may be selected from various types of polymers, such as thermoplastic, thermosetting plastic, or silicone. The latter could be advantageous in that it can be injected as a low viscosity liquid, well able to enter into the fine details of the nano-structured shim before setting to form the nanostructure 18 directly in the material of the front wall 3. Silicone would have the further advantage of having also inherent hydrophobic properties. Other useful polymers would be PC, COC, COP, PMMA or ASA, and the skilled person will readily be able to identify further polymers having suitable properties in terms of e.g. biocompatibility, mechanical strength, brittleness, transparency, adhesiveness, etc.
In respect of allowing the polymer to enter into the fine details of the nano-structure of the mould it may be of advantage to apply vacuum to the mould in order to avoid air being trapped in the fine nano-structure and hindering the proper ingress of the polymer material.
Rather than making the housing 1 from one single material, it may also be made from two or more materials with different material properties, one of which obviously being transparency in order to form the front wall 3 or transparent front areas matching the locations of the camera 10 and the illumination device (or devices). The other material or materials may be optimised for other properties such as compatibility with adhesives, opaqueness, resiliency, etc. As can be seen from
The housing 1 according to
It should be noted that the use of nickel shim is not the only way of providing the complementary nano-structure, it may be formed in other materials or even directly in the wall of the mould cavity in which the front wall 3 is moulded.
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