Patent Publication Number: US-2023157519-A1

Title: A handle for an endoscope

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a National Stage entry under 35 U.S.C. § 371 of International Application No. PCT/DK2021/050115, filed Apr. 21, 2021, which claims priority from and the benefit of Danish Patent Application No. PA 2020 70256, filed Apr. 24, 2020; said applications are incorporated by reference herein in their entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to an endoscope, more specifically but not exclusively a duodenoscope, and in particular to the assembly of the endoscope. 
     RELATED ART 
     A duodenoscope is a flexible endoscope configured to access a patient&#39;s duodenum from the stomach via the patient&#39;s mouth and esophagus. When the tip of the insertion cord is positioned in the duodenum there is a need to guide a tool radially from the tip, e.g. towards the biliary ducts in the wall of the duodenum. For that purpose the camera and the exit of a working channel of a duodenoscope is, unlike many other types of endoscopes, not positioned at the end surface of the distal tip of the endoscope. Instead it is arranged at an angle, typically perpendicular to the lengthwise direction of the insertion cord, but still in close proximity to the distal tip of the endoscope. Moreover, in order to accommodate different needs for guiding the tool the exit port of the working channel is provided with a lever that is operated by pulling and pushing a wire connected to an operating member at the endoscope handle. The lever or tool lift is also known as an Albarran mechanism from the original inventor. The Albarran mechanism is essentially a hinged arm arranged in its inactive position as an extension of the wall of the working channel from the exit port on one side thereof. The hinge is in close proximity to the exit port and so arranged that, when activated, the arm or a similar lifting piece may swing in front of the exit port and divert the tool into the field of view of the camera, i.e. also in a direction at an angle, preferably perpendicular, to the longitudinal direction of the insertion cord. An example of such an arrangement is disclosed in U.S. Pat. No. 9,089,263. 
     As will be understood, a duodenoscope is a specialized or dedicated endoscope, and many features that will be referred to may be applicable to endoscopes in general and not just duodenoscopes. In this description it is to be understood that when reference is made to endoscopes in general it is to be understood as likewise referring to a duodenocope, i.e. a duodenoscope comprising when features applicable to endoscopes in general. 
     When the endoscope is inserted into a patient via the mouth, oral cavity, esophagus and the stomach, the insertion cord is advanced via a series of twist and turns and advances. For this the distal end of the insertion cord of the endoscope comprises a bending section comprising a series of articulated segments of which the tip part with the camera and the exit port form the distalmost segment. The bending section is controlled by one or more levers or wheels on the handle of the endoscope, allowing the operator to bend the bending section to a desired curvature in one or more directions. For duodenoscopes there are typically two levers for controlling four directions of bending, i.e. what would normally be referred to as left, right, up and down if the view of the camera were forward from the distal end. When, however, the view of the camera is not forward, e.g. in a duodenoscope the operator does not have this left, right, up, down sense from the camera view and the corresponding motions of the handle necessary in conjunction with the bending, turning and advancing are much less intuitive. It is therefore important that the position of the camera, i.e. the field of view thereof, is well known and precise with respect to the handle. 
     An endoscope is assembled from many separate parts and subassemblies, including one or more handle parts and an insertion tube forming the majority of the insertion cord. In view of the above it is therefore of importance to keep track of the orientation of the insertion tube with the camera with respect to the handle parts, e.g. housing shells, when assembling the insertion tube including the camera and other parts with the handle housing. 
     The insertion tube typically comprises a helically wound member preventing the insertion tube from kinking or otherwise collapsing, while still allowing the insertion tube with a flexibility, so as to allow it to adapt to and follow the tortuous insertion passage through the body cavities, e.g. the path mentioned above through mount, oral cavity esophagus, stomach, and duodenum. The helically wound member is normally covered with further layers, such as braids and sealing outer layers. An endoscope with such an insertion tube is disclosed in US2009/0171158. 
     In US2009/0171158 the proximal end of the insertion tube is terminated within the handle of the endoscope using an arrangement comprising multiple mouth rings and other parts secured to one another by welding, crimping and by means of screws. In a few embodiments the welding is omitted, and instead an externally threaded mouth ring matching the pitch and dimensions of the helically would member is screwed into the helically wound member. This in turn is secured to a second, outer mouth ring by plastic deformation of the latter. The second outer mouth ring is, in turn, secured to one of multiple linkage members within the handle of the endoscope, by means of screws. 
     In KR20190112877 the proximal end of the insertion tube of the insertion cord of a duodenoscope is terminated in an intermediate handle part that can releasably be secured against rotation by pressing it against the remainder of the handle housing by means of a tightening ring. The tightening ring has an internal thread that engages an external thread formed in a transition part formed by two housing shell parts. No details are disclosed on how the insertion tube part of the insertion cord is itself secured in the intermediate part. 
     Trends in medical endoscopes and in particular duodenoscopes are going towards disposable endoscopes, i.e. endoscopes for single use on one patient only, before they are disposed of. The costs therefore need to be kept down, as compared to traditional reusable endoscopes that cleaned and sterilized between uses on different patients. 
     The parts therefore must be low cost and assembly of the parts efficient. The rather complex arrangements of US2009/0171158 do not lend themselves to this. Moreover, US2009/0171158 appears to be a forward looking endoscope and there are no considerations regarding the angular orientation of the insertion tube with respect to the handle. 
     As for the insertion tube, a desired length is normally cut from a longer length of prefabricated tube comprising e.g. the helically wound member, the braided layer and the outer sealing layer. Cutting such a prefabricated tube in a manner where the cuts of the helically wound member are located in a precise manner with respect to the circumference of the insertion tube, i.e. angular location, is difficult. 
     BRIEF DESCRIPTION OF THE DISCLOSURE 
     On this background it is the object of the disclosure to provide an endoscope, in particular but not exclusively, a duodenoscope, with a construction using few and low-cost parts, and at the same time the renders itself for easy and efficient assembly. 
     According to a first aspect of the disclosure this is achieved by a handle for an endoscope, said handle having a proximal end and a distal end, and said handle comprising a first shell-shaped housing part and a second shell shaped housing part, where said first shell shaped part and said second shell-shaped part are adapted for mutual engagement so as to form a housing, characterized in that said first shell-shaped housing part and said second shell-shaped housing each comprise an outer surface adapted to form together an exterior surface of said housing, wherein a first recess is provided in said first outer surface of said first shell-shaped housing part and wherein a second recess is provided in the second outer surface of the second outer shell-shaped housing part, said first and second recesses being so arranged and configured that when the first and second shell-shaped housing parts are mutually engaged an annular circumferential recess is provided in the exterior surface of the housing, and in that said handle further comprises a hoop adapted to be received in said annular circumferential recess and hold said first and second shell-shaped housing parts together. 
     According to a second aspect of the disclosure, the object is achieved in by the use of a hoop in holding a first shell-shaped housing part and a second shell-shaped housing part of an endoscope together. 
     According to a third aspect of the disclosure, the object is achieved by a system comprising an endoscope according to the first aspect of the disclosure and a display unit connectable to said endoscope. 
     According to a preferred embodiment of the first aspect of the disclosure, the annular circumferential recess has a bottom with a taper towards the distal end of the handle. This allows the hoop to be easily slid over the shell-shaped housing parts and engage into the annular circumferential recess. 
     According to a further preferred embodiment of the first aspect of the disclosure, the bottom of the annular circumferential recess comprises a frusto-conical surface. This ensures good engagement between the surfaces and ensures that hardly any gaps where pollutants may accumulate during the use of the endoscope exist. 
     According to another preferred embodiment, at least one of said first or second shell-shaped member comprises an interior surface, where said interior surface is adapted to receive and secure in position with respect to said interior surface a coupling member for an insertion tube of the endoscope. This allows the easy mounting of an insertion cord sub-assembly which will then be held securely in position by the handle housing parts. 
     According to yet another preferred embodiment, the coupling member is secured against rotation with respect to the handle in a longitudinal direction from the proximal end to the distal end of the handle. This is advantageous when the endoscope is not a forward looking endoscope. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The disclosure will now be made in greater detail based on non-limiting exemplary embodiments and with reference to the drawings on which: 
         FIG.  1    shows as system comprising an endoscope according to the disclosure and a display unit, 
         FIG.  2    shows a first handle housing part for the endoscope, 
         FIG.  3    shows a second handle housing part for the endoscope, 
         FIG.  4    shows a detail of the distal end of the handle housing part of  FIG.  2   , 
         FIG.  5    shows a coupling member according to the disclosure 
         FIG.  6    shows how the coupling member engages a wound helical member of the insertion tube, 
         FIG.  7    shows an elevated view of the coupling member placed in position in the first handle housing part, 
         FIG.  8    shows a third handle housing member for securing the first and second handle housing parts and the coupling member. 
         FIG.  9    shows an sub-assembly including the coupling member of  FIG.  7    and the insertion tube of  FIG.  6   . 
     
    
    
     DETAILED DESCRIPTION 
     Turning first to  FIG.  1   , a system comprising a medical device, such as an endoscope, more specifically a duodenoscope  1 , and a display unit  100  is shown. The endoscope comprises an insertion cord with an insertion tube  2  extending from the distal end  3  of the handle  4 . For illustration purposes the distal end of the insertion cord has been omitted. At or close to the proximal end of the handle operating members such as rotary knobs  5  are located. 
     As can be seen from  FIGS.  2  and  3   , the handle comprises two matching shell-shaped parts, i.e. a first handle housing part  6  and a second handle housing part  7  which when joined form exterior of the handle  4  protecting the internal parts (not shown). For the joining and mutually securing of the first and second handle parts  6 ,  7 , they may comprise mutually engaging locking members such as barbs  8  and lugs  9  adapted to interlock the two housing parts, so as to form the majority of the handle housing. Each of the shell-shaped first and second handle housing parts  6 ,  7  comprise an interior surface and an exterior surface, as defined by the assembled handle, i.e. so that the essentially convex surface of each shell-shaped handle housing part  6 ,  7  together provide the exterior surface of the assembled handle  4 . 
     In  FIG.  4    the distal end of the first handle housing part  6  is shown in greater detail. As can be seen the first handle housing part  6  has a taper towards the distal end of the handle. In the external surface of the tapered part a recess  10  is provided, which, together with a corresponding recess  11  in the external surface of the second handle housing part  7 , form a circumferential groove such as an annular recess when the first handle housing part  6  and the second handle housing part  7  are joined. On the interior surface of the first handle housing part  6  a first semicircular rib  12  and a second semicircular rib  13  are formed. Between the first and second semicircular ribs  12 ,  13  a shoulder  17  or ledge is provided. Adjacent the shoulder  17  a number of teeth  18  protruding from the interior wall of the first handle housing part  6  are provided. 
     Likewise, as can be seen in  FIG.  3   , on the interior surface of the second handle housing part  7  a third semicircular rib  14  and a fourth semicircular rib  15  are formed. Between the third and fourth semicircular ribs  14 ,  15  a shoulder  16  or ledge is provided. Adjacent the shoulder  16  a number of teeth  25  protruding from the interior wall of the second handle housing part  7  are provided. 
     The first and second semicircular ribs  12 ,  13  together with the interior wall of the first handle housing part  6  form part of a receptacle for a coupling member  19  shown in  FIG.  5   . 
     The coupling member  19  provides a simple and cost-efficient way of assembling the insertion cord with the handle  4  of the endoscope  1 . 
     The coupling member  19  comprises a generally tubular member with a through passage  20  from the proximal end  21  towards the distal end  22 . The circumference at the proximal end  21  is larger than at the distal end  22  so that the coupling member generally has a taper towards the distal end  22 . As can be seen, the taper is not smooth but comprises at least one shoulder  23  adapted to match the shoulder  17  in the first handle housing part  6  and a corresponding shoulder  16  in the second handle part  7 . Also, the coupling member comprises a number of teeth  24  arranged circumferentially around a mid-section of the coupling member  19  (a second sector of the coupling member  19 ) adjacent the shoulder  23 . The teeth  24  are so located and distributed that at least some of them will engage between the teeth  18  in the first handle housing part  6  or a corresponding set of teeth  25  on the second handle housing part  7 . Towards the distal end  22  the coupling member  19  comprises a cylindrical or preferably frusto-conical part (a first sector of the coupling member  19 )  29  which is provided with an external thread  26   a - 26   f  adapted to engage between the windings of a wound helical member forming part of the wall of the insertion tube  2 . Using the external thread  26   a - 26   f  the coupling member  19  may be screwed into the proximal end of the wall of the insertion tube  2  to form an insertion cord sub-assembly  40  including the insertion tube  2  and a camera  42 , as seen in  FIG.  9   . The part  29  is preferably frusto-conical in order to expand the wound helical member  30  slightly, when it is screwed into the latter, as mentioned above and shown in  FIG.  6   , so as increase the force between the coupling member  19  and the insertion tube  2  holding them together. The external thread  26   a - 26   f  may be continuous or, as shown, segmented. Glue may be added to ensure that the insertion tube  2  remains in position on the coupling member  19 . Preferably the thread  26   a - 26   f  is therefore segmented, so as to allow glue to be located in the gaps between the segments and form a glue bond between the coupling member  19  and the insertion tube  2  so as to hold them even better together. Optionally, the coupling member  19  may comprise and end stop  27  preventing it from being screwed too far into the insertion tube  2 . 
     The insertion cord sub-assembly may then be placed in the receptacle where shoulder  23  and the surface of the proximal end will engage the shoulder  17  and semicircular rib  13  and secure the insertion cord sub-assembly in the longitudinal direction with respect to the handle  4 . The rotational orientation of the insertion cord sub-assembly with respect to the first handle housing part  6  may then be checked and adjusted. This is preferably done using the camera  42  in the distal end of the insertion cord sub-assembly. If adjustment is not correct, the insertion cord sub-assembly may be turned so that the engagement between the teeth  18  in the first handle housing part and the teeth  24  on the coupling member  19  changes. When eventually the correct rotational position is reached, the final position of the insertion cord sub-assembly may be secured by attaching the second handle housing part  7  to the first handle housing part  6  whereby the teeth  25  of the second handle housing part  7  also engage and secure the teeth  24  of the coupling member  19 . 
     Using the camera for the verification of the rotational position is advantageous in the sense the camera, being the single most costly part of the endoscope, needs to be checked one or more times during the assembly process anyway in order to replace it if defective, rather than rejecting the final endoscope. 
     Evidently, the use of engaging teeth  18 ,  24  and  25  is not the only way to secure against rotation, in principle any kind of interlocking geometries may be used. Using engaging teeth  18 ,  24  and  25 , however allows for sufficiently small discrete angular steps to achieve sufficient precision. Similarly, the preferably semicircular ribs  12 - 15  need not be semicircular. In principle any protrusion or other discontinuity on the interior surface of the handle housing parts  6 ,  7  that will prevent longitudinal displacement of the coupling member  19 , and hence the subassembly will suffice. However, semicircular ribs  12 - 15  forming together essentially two full circular ribs will provide maximum strength and hold for a given thickness of the ribs  12 - 15 . The given thickness of the ribs  12 - 15  on the other hand is largely determined by thickness of the walls of the respective handle housing part  6 ,  7  because of the aim to keep material thicknesses equal throughout the moulded items to facilitate the moulding process. That is to say, the widths of the ribs  12 - 15  essentially correspond to the wall thickness of the first and second handle housing parts  6 ,  7 . 
     With the subassembly in place in the correct orientation with respect to the first shell-shaped handle housing part  6 , the subassembly is secured by the joining of the first and second handle housing parts  6 ,  7 . In doing so the mutual locking means  8 ,  9  engage and interlock the first and second shell-shaped handle housing parts  6 ,  7 . Other mutual locking means than those exemplified are of course known to the skilled person. However, since the insertion tube  2  forming part of the insertion cord subassembly extends a substantial distance from the distal end of the handle  4  there will in use be substantial forces acting upon the coupling member  19 . The forces will transmit through the coupling member  19  and essentially try to pry the first and second handle housing parts  6 ,  7  apart. The two handle housing parts  6 ,  7  are therefore secured against each other not only by means of interlocking members  8 ,  9  but further by a third handle housing part in the form of a hoop  28  arranged externally on the first and second handle housing parts  6 ,  7 , and serving as a locking ring. The hoop  28  is essentially an annular member with a frusto-conical shape, preferably both on the inner surface  31  and on the outer surface  32 . The hoop  28  is made from a material with sufficient tensile strength to withstand the forces transmitted from the coupling member  19  via the handle housing parts  6 ,  7 . However, the hoop  28  has some elasticity as do the handle housing parts  6 ,  7  thereby allowing the hoop  28  to be slit over the insertion tube  2  and the tapered distal end part of the handle  4  into the annular recess formed by the recesses  10 ,  11 . The recesses  10 ,  11  are adapted to match the varying inner circumference of the hoop  28 , i.e. also have a taper, and the width of the recesses match the height of the hoop  28  to leave as small gaps as possible between the hoop  28  and the handle  4 . The bottom of the groove or complete recess comprising the recesses  10  and  11  preferably comprises a frusto-conical surface, but it is of course not excluded that it may be slightly convex or concave, in which case the inner surface  31  of the hoop  31  would preferably have a matching shape. Similarly, the outer surface  32  of the hoop  28  is adapted to match the taper of the distal end of the handle  4 , so as to provide as smooth an outer surface of the handle  4  as possible. 
     The location of the recesses  10 ,  11  preferably register with the coupling member  19 , more specifically with the cylindrical or preferably frusto-conical part  29  which is provided with the external thread  26   a - 26   f  of the coupling member  19 . This is the narrowest part of the coupling member  19  and allows one side of the recesses  10 ,  11 , respectively to be provided in conjunction with the shoulder  17 , in turn keeping the wall thickness of the handle housing parts  6 ,  7  more or less constant for the above-mentioned moulding reasons.