Cleaning device for suction and flushing of a surgical site, and method for its production

Abstract

Method to produce a cleaning device (10) to flush a surgical site and suction fluid from the surgical site comprising the steps of a) providing a cleaning head (30) designed to receive a proximal end of an elongate medical instrument; a plurality of channels (50) and of tubes (100), each tube (100) connecting a channel (50) to a source of flushing fluid (110) or to a suction source (120); and b) connecting each tube (100) to a channel (50). The method further comprises the steps of c) providing a plurality of pipe fittings (130), each being designed to be inserted in a channel (50) and in a tube (100) to connect them fluidly; d) inserting a proximal section (140) of each pipe fitting (130) in a receiving portion (150) of the corresponding channel, wherein a first interstice (170) is formed between the receiving portion (150) and the pipe fitting (130); e) inserting a distal section (180) of each pipe fitting (130) in the corresponding tube (100), thereby forming a second interstice (190) between the tube (100) and the pipe fitting (130); f) injecting an adhesive agent (220) under the effect of capillarity into the first interstice (170) and into the second interstice (190).

Description

[0001] Cleaning device for suction and flushing of a surgical site , and method for its production

[0002] The invention relates to a cleaning device for suction and flushing of a surgical site suitable for being mounted circumferentially around an elongate medical instrument , in particular an endoscopic device . The invention further relates to a method for producing such a cleaning device .

[0003] When performing surgical procedures on the human or animal body in which an elongate medical instrument is navigated to a speci fic location inside the body, a cleaning device can be used to irrigate or flush the surgical site with fresh flushing fluid and to suction the flushing fluid together with blood and tissue residues back out from the surgical site . In endoscopic procedures , flushing also serves to maintain a clear view through an endoscope .

[0004] To permit suction and flushing simultaneously, it is necessary for such a cleaning device to have at least two channels , speci fically a suction channel and a flushing channel , because the fresh flushing fluid should not mix with the suctioned fluid before reaching the surgical site .

[0005] WO 00 / 48505 Al discloses an endoscope having an outer shaft in which an optical channel receiving an optical system is situated . Said outer shaft also contains a channel for receiving a working element , at least one longitudinal supply channel for a medium and at least one longitudinal discharge channel for separate delivery and evacuation of the medium . The optical channel and the at least one supply channel and / or the at least one discharge channel are configured as segments of a shaped shaft which is housed in the outer shaft and presents cross-sectional cavities . A shaped shaft of this kind is relatively complicated to produce .

[0006] WO 2009 / 095915 Al discloses a distal head unit for an elongate medical instrument like an endoscope , in particular a j et spray head unit suitable for being mounted circumferentially around an elongate medical instrument , comprising a ring-shaped element that is fitted with at least a first set of distally- directed apertures that extend from the distal face to the proximal face of said element , wherein each of said apertures is adapted such that the proximal end thereof may be connected to a source of pressuri zed irrigation fluid . The distal head unit is designed for cleaning a colonic or other lumen prior to , and / or during, endoscopic procedures . However, it is not designed to clean speci fically a distal end of the elongate medical instrument and therefore not ef ficient for example to maintain a clear view through an endoscope , in particular an optical element at a proximal end of the endoscope .

[0007] It is an obj ect of the invention to provide a cleaning device to flush a surgical site and suction fluid from the surgical site that is suitable for being mounted circumferentially around an elongate medical instrument , in particular an endoscopic device , thereby flushing and cleaning a proximal end of the elongate medical instrument in a mounted state of the cleaning device and the elongate medical instrument . At the same time , the cleaning device is easy to produce , has a compact cross section for combined suction and flushing of the surgical site and the proximal end of the elongate medical instrument . Speci fically in the case where the elongate medical instrument is an endoscopic device having an optical element in the form of or including a transparent plate arranged proximally for the observation of the surgical site , the cleaning device ensures an ef ficient cleaning of the optical element and does not limit the field of vision of the operator .

[0008] A further obj ect of the invention is to make available a method for producing such a cleaning device .

[0009] This obj ective is met according to the present invention by providing a cleaning device with the features of claim 9 and a method to produce such a cleaning according to claim 1 .

[0010] Further advantageous embodiments of the invention are the subj ect of the dependent claims .

[0011] According to a first aspect of the invention, a cleaning device to flush a surgical site and suction fluid from the surgical site suitable for being mounted circumferentially around an elongate medical instrument , in particular an endoscopic device , is disclosed .

[0012] The cleaning device comprises a cleaning head shaped in the form of a ring extending along a cleaning head longitudinal axis and designed to receive a proximal end of the elongate medical instrument .

[0013] Further, the cleaning head comprises a plurality of channels extending each from a proximal channel opening formed in a cleaning head proximal face and a distal channel opening formed in a cleaning head distal face . Preferably, the channels have each time an axis that extends parallel to the cleaning head longitudinal axis to form a compact cross section .

[0014] The cleaning device also comprises a plurality of tubes , each tube of the plurality of tubes connecting a corresponding channel of the plurality of channels to a source of flushing fluid or to a suction source . The cleaning head comprises also a mounting interface designed to allow the assembly of the cleaning head with the tubes .

[0015] It is noted that the term "distal" is used throughout the disclosure to refer to the direction, orientation or region facing the operator and the term "proximal" is used to refer to the direction, orientation or region facing away from the operator, i . e . in the direction to the or closest to the patient .

[0016] According to the invention, the cleaning device comprises a plurality of pipe fittings , each pipe fitting being inserted on its proximal side in a corresponding channel of the plurality of channels and on its distal side in a corresponding tube of the plurality of tubes to connect fluidly the corresponding channel and the corresponding tube . Each time , a pipe fitting is used to connect one channel with one tube . A pipe f itting can be in the form of hollow cylinder having an inner diameter designed to allow the passage of flushing fluid or suctioned fluid, depending on the use of the channel and tube it connects .

[0017] The pipe fitting has a length that is dimensioned to provide for a pipe fitting outer envelope having a surface allowing, on one side , gluing the pipe fitting outer envelope to a channel inner surface of the channel in a first interstice formed between the channel and the pipe fitting, and, on the opposed side , gluing the pipe fitting outer envelope to a tube inner surface of the tube in a second interstice formed between the tube and the pipe fitting, when the pipe fitting is in an inserted state . Appropriate lengths are therefore preferably in a range of 3 mm to 30 mm, more preferably 5 mm to 10 mm .

[0018] Each time , the tube has a tube inner diameter forming the second interstice extending circumferentially between the tube and the pipe fitting in the inserted state of the distal end of the pipe fitting . The tube inner diameter is configured such that the pipe fitting can be inserted slidingly in the tube , while allowing creation of a capillarity ef fect between the pipe fitting and the tube when an adhesive agent is inj ected in the second interstice .

[0019] Preferably, the distal channel opening of each channel abuts each time a proximal end of the corresponding tube in the assembled state of the cleaning device . This arrangement has the advantage that there is no interspace left between the tubes and the cleaning head distal face that could contain impurities or residues .

[0020] The mounting interface includes a receiving portion formed by a portion of each channel and arranged adj acent to its distal channel opening, i . e . to the distal channel opening of the channel , and designed to receive the pipe fitting corresponding to the channel . In the inserted state of a proximal end of the pipe f itting, the first interstice extending circumferentially between the receiving portion and the pipe fitting is formed, i . e . is present , wherein the receiving portion is arranged in each channel adj acent to its distal channel opening .

[0021] In a preferred embodiment , the receiving portion has a f rustoconical shape with a receiving conical angle , the diameter of the receiving portion tapering each time in the direction from distal to proximal , from the distal channel opening having a receiving diameter greater than the outer diameter of the corresponding pipe fitting to a proximal end of the receiving portion having an end diameter equal to the outer diameter of the corresponding pipe fitting . It follows that the receiving diameter and the end diameter are dimensioned such that the pipe fittings abut in the receiving portion .

[0022] The conical angle of the f rustoconical shape is defined as the angle formed between the axis and the envelope of the f rustoconical shape as measured in a longitudinal cross section plane containing the longitudinal axis of the channel . According to this definition, an opening angle of the f rustoconical shape is twice the conical angle .

[0023] The receiving portion can have a f rustoconical shape and comprise one or more portions having each a f rustoconical shape , each of the one or more portions having a di f ferent conical angle . For example , the conical angle of the one or more portions can be each time smaller in the direction from distal to proximal .

[0024] In a preferred embodiment , the mounting interface further includes an abutment portion formed by a portion of the channel and arranged in a coaxial extension of the receiving portion proximally adj acent to the receiving portion . The abutment portion has a diameter at its distal end equal to the end diameter of the receiving portion and a diameter at its proximal end smaller than the outer diameter of the pipe fitting to form, in the inserted state of a proximal end of the pipe fitting, a circumferential abutment delimiting proximally the first interstice extending circumferentially between the receiving portion and the pipe fitting . Depending on the exact outer diameter of the corresponding pipe fitting that are inherent to the production of the pipe fittings , the circumferential abutment will be formed more distally for a larger outer diameter or more proximally for a smaller outer diameter . This is an advantage of this arrangement that does not require narrow manufacturing tolerances for the outer diameter of the pipe fittings . Indeed, the pipe fittings always abut either the corresponding receiving portions or abutment portions . Preferably the abutment portion has a f rustoconical shape having an abutment conical angle .

[0025] The first interstice is formed each time distally to the circumferential abutment , between the pipe fitting outer envelope and an inner surface of the receiving portion, the inner surface of the receiving portion forming a portion of the channel inner surface .

[0026] In a preferred embodiment , the proximal end of the abutment portion forms each time the proximal channel opening to form a compact cleaning head, as seen in the axial direction .

[0027] Further, the first interstice and the second interstice are designed to allow the inj ection of an adhesive agent into the first interstice and the second interstice under the ef fect of capillarity . The tube is fastened in a sealed manner with the cleaning head after curing of the adhesive agent .

[0028] In a preferred embodiment , the mounting interface includes a plurality of inj ection channels , an inj ection channel of the plurality o f channels extending each time preferably outwards with a radial component from the receiving portion of a channel of the plurality of channels to an inj ection opening and being each time designed to allow the inj ection of an adhesive agent through the inj ection channel into the first interstice and further into the second interstice . The tube is fastened in a sealed manner with the cleaning head after curing of the adhesive agent . Preferably, the inj ection channel extends each time radially outwards from the receiving portion to the inj ection opening to improve distribution of the adhesive agent .

[0029] The first interstice and the second interstice form an intervening space that is dimensioned to create a capillarity ef fect acting on the adhesive agent that is inj ected in the intervening space , resulting in adhesive agent spreading circumferentially along the pipe fitting outer envelope distally and proximally from the inj ection channel .

[0030] The arrangement has several advantages , namely broad tolerances for the dimensions of the pipe fittings , in particular the outer diameter and the length, as well as for the dosage of the adhesive agent . As already mentioned, the pipe fittings are inserted each time in the receiving portion, wherein the outer diameter of the pipe fittings will always abuts the inner surface of the receiving portion while a precise position in the receiving portion is not critical . Further, the length of the pipe fittings is also not critical because di f ferences in the length of pipe fittings can be compensated each time in the tubes by introducing deeper or less deep the pipe fittings without detrimental ef fects to the assembly . The tapering form of the receiving portion is designed such that at least a minimum length of the pipe fitting is covered with adhesive agent , i . e . is included in the first interstice , to ensure the required resistance to traction is obtained when adhesive agent is cured . Further, the adhesive agent being spread by capillarity, its dosage does not need narrow tolerances because the adhesive agent must not fill in the full first interspace and second interspace to ensure that the tube is fastened in a sealed manner with the cleaning head, i . e . the adhesive agent does not need to reach the distal end of the pipe fitting on one side and the proximal end of the pipe fitting on the other side . The tube is fastened in a sealed manner with the cleaning head as soon as the adhesive agent has surrounded the pipe fitting over its whole circumference both in the first interstice and in the second interstice . In other words , the dosage can be based on an estimated volume of the first interstice and second interstice and is performed such that a quantity of adhesive agent smaller by 5% to 30%, preferably by 10% to 15%, than the estimated volume is supplied. Commercially available dosing systems can have an accuracy of -50% to +100% of the target adhesive quantity for such small quantities as those necessary for the assembly of the present device. However, the limitation by the interstices of the volume that can be used allows a better control of the adhesive quantities supplied. As a further advantage, it can also be avoided that adhesive agent spills out distally and proximally from the pipe fittings.

[0031] In a preferred embodiment, the receiving conical angle is in a range of 0.05° to 3°, preferably 0.25° to 1°, more preferably is 1°. The range is chosen to allow an insertion of the pipe fitting in the receiving section that enables an easy assembly. At the same time, the range allows demolding of the mounting interface and, where appropriate, of the whole cleaning head if it is produced by injection molding.

[0032] In a preferred embodiment, the distal channel opening has a receiving diameter that is 0.01 mm to0.20 mm, preferably 0.05 mm to 0.10 mm, larger that the outer diameter of the pipe fitting. The ranges chosen limit the size, in particular the diameter of the cleaning head. In a preferred embodiment , the end diameter of the abutment portion is equal to the inner diameter of the corresponding pipe fitting . This arrangement allows the largest clearance of the channels for flushing or sucked fluids .

[0033] In a preferred embodiment , the receiving portion comprises a guiding portion having a f rustoconical shape with a guiding conical angle smaller than the receiving conical angle , the guiding portion being arranged distally adj acent to the abutment portion . The guiding portion is in the coaxial extension of the receiving portion . The smaller guiding conical angle allows clamping each time the corresponding pipe fittings so that the pipe fittings are kept in the receiving opening without the help of any external means during the assembly .

[0034] In a preferred embodiment , the guiding conical angle is in a range of 0 . 05 ° to 3 ° , preferably 0 . 25 ° to 1 ° , more preferably is 1 ° . The range is chosen to clamp the pipe fitting in the guiding portion while allowing the insertion of the pipe fitting . For this purpose , a proximal end of the guiding portion corresponds to the proximal end of the receiving portion, wherein a proximal end diameter of the guiding portion is the same as the end diameter of the receiving portion . A distal end diameter of a distal end of the guiding portion is smaller than the receiving diameter . At the same time , said range allows demolding of the mounting interface and, where appropriate , of the whole cleaning head i f it is produced by inj ection molding .

[0035] In a preferred embodiment , the cleaning head is produced by inj ection molding to allow lower production costs . The cleaning head can be made of materials like polycarbonate , polymethylmetacrylate , acrylonitrile butadiene styrene , polysul fone or other biocompatible materials .

[0036] In a preferred embodiment , the cleaning head comprises a deflector arranged proximally at a distance from proximal channel openings that are connected to the source of flushing fluid and overlapping each time at least partially, as seen in a plane perpendicular to the direction of flow of the flushing fluid at the proximal channel openings , the proximal channel openings . In this manner, the deflector deflects flushing fluid in a direction with a radially inwards component , to a medical device arranged at the proximal end of the elongate medical instrument . Preferably the deflector is in the form of a deflector plate for its simple production . The medical device can be or comprise an optical element in the form of or including a transparent plate arranged proximally for the observation of the surgical site , wherein the optical element is preferably inclined with respect to the longitudinal axis of the elongate medical instrument . At the same time , channels connected to the suction source can suck flushing fluid to improve cleaning for example of the optical element .

[0037] In a preferred embodiment , the deflector plate is arranged in a plane perpendicular to the direction of flow of the flushing fluid at the proximal channel openings , i . e . perpendicular to the axis of the channels . To ease demolding in case it is produced by inj ection molding, the deflector plate can be arranged in a plane inclined in the direction from distal to proximal by an angle of 0 . 5 ° to 3 ° with respect to the cleaning head proximal face . Most preferably, the angle is 1 ° . This angle range allows an optimi zed distribution of flushing fluid while allowing an easier demolding of the cleaning head proximal face and the deflector plate i f the cleaning head is produced by inj ection molding .

[0038] In a preferred embodiment , the deflector plate overlaps the proximal channel openings that are connected to the source of flushing fluid completely to deflect flushing fluid at a right angle to have a stronger impact for example on the optical element arranged at the proximal end of the elongate medical instrument , especially i f the optical element is inclined .

[0039] The cleaning head is shaped in the form of a ring, thereby delimiting a receiving inner space for the proximal end of the elongate medical instrument and the receiving inner space forms a cleaning head opening in the cleaning head proximal face for the proximal end of the elongate medical instrument to reach the surgical site . Preferably, the cleaning head has a radial abutment proj ecting radially in the receiving inner space and designed to block the insertion in the cleaning head of the proximal end of the elongate medical instrument in the proximal direction . More preferably the radial abutment is arranged adj acent to the cleaning head proximal face to ensure that the proximal end of the elongate medical instrument is as close as possible to the cleaning head proximal face . This arrangement avoids that the proximal edge of the receiving inner space forms an obstacle in the field of vision . Further, the radial abutment has a circumferential length that is 15% to 25% , preferably 20% of the diameter of the cleaning head opening . Most preferably, the radial abutment comprises a first abutment element proj ecting from the cleaning head in the receiving inner space perpendicular to the cleaning head longitudinal axis and a second abutment element proj ecting from the first abutment element , wherein the distal surface of the second abutment element is inclined by an angle with respect to the cleaning head longitudinal axis . The angle can be between 20 ° to 45 ° , preferably 30 ° , but the range can be adapted to form an inclined surface complementary to the inclined proximal end of the elongate medical instrument . This arrangement allows to block the insertion of elongate medical instruments having a proximal end formed at a right angle or formed inclined with respect to their longitudinal axis .

[0040] In a preferred embodiment , the cleaning head is shaped in the form of an opened ring having a ring opening extending circumferentially and a thickened region, preferably in the form of a crescent , the thickened region being arranged diametrically opposed to the ring opening, and the plurality of channels are formed in the thickened region . The ring opening improves the field of vision of the operator in the direction of the ring opening when the elongate medical instrument has an optical element arranged at the proximal end . The ring opening can also allow the passage of at least a portion of the proximal end of the elongate medical instrument that can protrude further than the cleaning head proximal face . The thickened region allows the arrangement of channels in the cleaning head .

[0041] In a preferred embodiment , inj ection channels o f the plurality of inj ection channels have each time a recess extending radially from the receiving portion in direction to the inj ection opening and in fluid communication with the cleaning head distal face to allow the formation of a contact surface of the adhesive agent in the inj ection channel with the proximal end of the corresponding tube . The recess in the inj ection channels allows each time a fluid communication between the inj ection channels and the cleaning head distal face . In the assembled state , the proximal end of the tubes and the cleaning head distal face are flush so that the adhesive agent flowing each time through the recesses during inj ection has an increased contact surface with the tubes . The resistance of the assembly to traction is further improved .

[0042] In a preferred embodiment , the plurality of tubes are embedded in a connection tube designed to allow the insertion of the elongate medical instrument in the connection tube . The connection tube comprising the plurality of tubes simpli fies the assembly of the cleaning device . Indeed, the plurality tubes are kept in a fixed position and the number of parts to assemble is reduced . The connection tube extends from the plurality of channels to the source of flushing fluid and to the suction source , wherein the arrangement o f the plurality of tubes in the connection tube is kept to connect them to the source of flushing fluid or to the suction source .

[0043] The plurality of tube can also be provided as a unit formed of a plurality of tubes . The unit can be produced for example by extrusion or assembled from single tubes .

[0044] It is also conceivable to use tubes in the form of clippable tubes or plug-in tubes , separated from each other or embedded in a layer, and more generally any means allowing to connect fluidly corresponding channels and tubes of the cleaning device .

[0045] In a preferred embodiment , the connection tube has a clearance corresponding to the cross section of the elongate medical instrument to allow its insertion into the connection tube .

[0046] In a more preferred embodiment , the connection tube has a cross section is shaped in the form of a ring and has a tube thickened region, preferably in the form of a crescent , the plurality of channels being embedded in the tube thickened region . The tube thickened region is arranged to allow the connection of the corresponding channels and tubes . This embodiment is designed to be used with the cleaning head shaped in the form of an opened ring disclosed above , while the connection tube can be clamped along the elongate medical instrument to further improve the fixation of the cleaning device to the elongate medical instrument .

[0047] The connection tube can be made of materials like polyurethan, or polyvinylchloride or other biocompatible materials .

[0048] In a preferred embodiment , the plurality of tubes are connected to a hub on their side opposed to the cleaning head, the hub having a flushing fluid port designed to be connected with the source of flushing fluid and a suction source port designed to be connected with the suction source . The use of the hub allows a simple connection of the plurality of tubes to the source of flushing fluid and the suction source because only two ports instead of a plurality of tubes must be connected . Further, the hub has a hub mounting interface arranged on a hub proximal face and formed symmetrically to the cleaning head mounting interface with respect to a plane perpendicular to the cleaning head longitudinal axis to allow the connection of the plurality of tubes to the hub mounting interface each time by way of a pipe fitting in a manner corresponding to the connection of the plurality of tubes to the cleaning head mounting interface . This arrangement simpli fies the assembly of the cleaning device because the connection of the plurality of tubes to the hub has the same advantages as the connection of the plurality of tubes to the cleaning head .

[0049] In a preferred embodiment , a first group of channels is formed by channels connected to the source of flushing fluid and a second group of channels is formed by channels connected to the suction source . The first group of channels is arranged symmetrically to a longitudinal plane forming a symmetry plane of the cleaning head . This arrangement ensures a symmetrical distribution o f flushing fluid around the proximal end of the elongate medical instrument . Combined with the deflector plate according to the disclosure above , the arrangement allows ef ficient cleaning for example of a medical device in the form of the optical element arranged at the proximal end of the elongate medical instrument .

[0050] In a more preferred embodiment , the first group of channels are arranged in a first cleaning head region free of channels of the second group, channels of the second group being arranged at a circumferential distance of the first cleaning head region in a second cleaning head region . This arrangement provides for a supply of flushing fluid in the first cleaning head region where the first channels are arranged and suction from the second cleaning head region circumferentially adj acent to the first cleaning head region so that a flow from the first to the second cleaning head region can be created . Cleaning is thereby improved .

[0051] In a preferred embodiment , the channels of the first group of channels are formed in the same way, i . e . they have all the same geometry parameters , namely the same conical angle , the same receiving diameter, the same end diameter to receive the same outer diameter of the corresponding pipe fitting, wherein these parameters form a first group of parameters . Further, the channels of the second group of channels are formed in the same way . i . e . they have all the same geometry parameters forming a second group of parameters , namely the same conical angle , the same receiving diameter, the same end diameter to receive the same outer diameter of the corresponding pipe fitting, and the same diameter at the proximal channel opening, wherein these parameters are di f ferent to those of the first group . As a result , the dimensions of the structure provided for flushing fluid and sucking fluid can be adapted to the medical application . More preferably, the second group of channels have a smaller diameter at the proximal channel opening than the first group of channels to provide for a compact geometry . Further, tests have shown that flushing the proximal end of the elongate medical device is more ef ficient when it is performed by way of the first group of channels while the second group of channels , which are spaced farther apart , are more ef ficient for sucking fluid away from the proximal end of the elongate medical device , in particular of the optical element .

[0052] According to a second aspect of the invention, a method to produce a cleaning device to flush a surgical site and suction fluid from the surgical site suitable for being mounted circumferentially around an elongate medical instrument , in particular an endoscopic device , is disclosed .

[0053] The method disclosed can advantageously be used to produce a cleaning device according to any one of the embodiments disclosed above .

[0054] The method comprises the step of providing a cleaning head shaped in the form of a ring extending along a cleaning head longitudinal axis and designed to receive a proximal end of the elongate medical instrument . Preferably, the channels have each time an axis that extends parallel to the cleaning head longitudinal axis to form a compact cross section .

[0055] The cleaning head comprises a plurality of channels extending each from a proximal channel opening formed in a cleaning head proximal face and a distal channel opening formed in a cleaning head distal face .

[0056] Further, a plurality of tubes of the cleaning device are provided, each tube of the plurality of tubes being designed to connect a corresponding channel of the plurality of channels to a source of flushing fluid or to a suction source . Further, the method comprises the step of connecting each tube of the plurality of tubes to a corresponding channel of the plurality of channels .

[0057] According to the invention, the method comprises the step of providing a plurality of pipe fittings , each pipe fitting being designed to be inserted on its proximal side in a corresponding channel of the plurality of channels and on its distal side in a corresponding tube of the plurality of tubes to connect fluidly the corresponding channel and the corresponding tube .

[0058] Further, the method comprises the step of inserting a proximal section of each pipe fitting in a receiving portion formed by a portion of the corresponding channel , wherein the receiving portion is part of a mounting interface of the cleaning head . In the inserted state of a proximal end of the pipe fitting, a first interstice extending circumferentially between the receiving portion and the pipe fitting is formed . The receiving portion is arranged in each channel adj acent to its distal channel opening .

[0059] In a preferred embodiment , the receiving portion has a f rustoconical shape with a receiving conical angle , the diameter of the receiving portion tapering each time in the direction from distal to proximal from the distal channel opening having a receiving diameter greater than an outer diameter of the corresponding pipe fitting to a proximal end of the receiving portion having an end diameter equal to the outer diameter of the corresponding pipe fitting . As a result , the pipe fittings abut each time in the receiving portion . In a preferred embodiment , the mounting interface further includes an abutment portion formed by a portion of the corresponding channel and arranged in a coaxial extension of the receiving portion proximally adj acent to the receiving portion . The abutment portion has a diameter at its distal end equal to the end diameter of the receiving portion and a diameter at its proximal end smaller than the outer diameter of the pipe fitting to form, in the inserted state of a proximal end of the pipe fitting, a circumferential abutment delimiting proximally the first interstice extending circumferentially between the receiving portion and the pipe fitting . The receiving portion is arranged in each channel adj acent to its distal channel opening . Depending on the exact outer diameter of the corresponding pipe fitting that are inherent to the production of the pipe fittings , the circumferential abutment will be formed more distally for a larger outer diameter or more proximally for a smaller outer diameter . This is an advantage of the method that does not require narrow manufacturing tolerances for the outer diameter of the pipe fittings . Indeed, the pipe fittings always abut either the corresponding receiving portions or abutment portions . Preferably the abutment portion has a f rustoconical shape having an abutment conical angle .

[0060] Further, the method comprises the step of inserting a distal section of each pipe fitting in the corresponding tube to connect fluidly the corresponding channel and the corresponding tube , thereby forming a second interstice extending circumferentially between the tube and the pipe fitting in an inserted state of the distal end of the pipe fitting . In the inserted state , the distal channel opening of the corresponding channel abuts a proximal end of the corresponding tube , the tube having a tube inner diameter designed to form the second interstice extending circumferentially between the tube and the pipe fitting . The tube inner diameter is configured such that the pipe fitting can be inserted slidingly in the tube , while allowing creation of a capillarity ef fect between the pipe fitting and the tube when the adhesive agent is inj ected in the second interstice .

[0061] Further, the method comprises the step of inj ecting an adhesive agent under the ef fect of capillarity into the first interstice and further into the second interstice . After curing of the adhesive agent , the tube is fastened in a sealed manner with the cleaning head .

[0062] In a preferred embodiment , the method comprises the step of inj ecting in each inj ection channel of a plurality of inj ection channels included in the mounting interface the adhesive agent through the inj ection channel under the ef fect of capillarity into the first interstice and further into the second interstice . After curing of the adhesive agent , the tube is fastened in a sealed manner with the cleaning head . Preferably, each inj ection channel extends outwards with a radial component from the receiving portion of a channel of the plurality of channels to an inj ection opening of the inj ection channel .

[0063] The first interstice and the second interstice form an intervening space that is dimensioned to create a capillarity ef fect acting on the adhesive agent that is inj ected in the intervening space , resulting in adhesive agent spreading circumferentially along the pipe fitting outer envelope distally and proximally from the inj ection channel .

[0064] The method has several advantages , namely broad tolerances for the dimensions of the pipe fittings , in particular the outer diameter and the length, as well as for the dosage of the adhesive agent . As already mentioned, the pipe fittings are inserted each time in the receiving portion, wherein the outer diameter of the pipe fittings will always abuts the inner surface of the receiving portion while a precise position in the receiving portion is not critical . Further, the length of the pipe fittings is also not critical because di f ferences in the length of pipe fittings can be compensated each time in the tubes by introducing deeper or less deep the pipe fittings without detrimental ef fects to the assembly . The tapering form of the receiving portion is designed such that at least a minimum length of the pipe fitting is covered with adhesive agent , i . e . is included in the first interstice , to ensure the required resistance to traction is obtained when adhesive agent is cured . Further, the adhesive agent being spread by capillarity, its dosage does not need narrow tolerances because the adhesive agent must not fill in the full first interspace and second interspace to ensure that the tube is fastened in a sealed manner with the cleaning head, i . e . the adhesive agent does not need to reach the distal end of the pipe fitting on one side and the proximal end of the pipe f itting on the other side . The tube is fastened in a sealed manner with the cleaning head as soon as the adhesive agent has surrounded the pipe fitting over its whole circumference both in the first interstice and in the second interstice . In other words , the dosage can be based on an estimated volume of the first interstice and second interstice and is performed such that a quantity of adhesive agent smaller by 5% to 30% , preferably by 10% to 15% , than the estimated volume is supplied . As a further advantage , it can also be avoided that adhesive agent spills out distally and proximally from the pipe fittings .

[0065] In a preferred embodiment , the step of inserting the proximal section of each pipe fitting in the receiving portion of the corresponding channel further comprises the step of inserting the proximal section of each pipe fitting in a guiding portion comprised in the receiving portion, the guiding portion having a f rustoconical shape with a guiding conical angle smaller than the receiving conical angle , the guiding portion being arranged distally adj acent to the abutment portion . The smaller guiding conical angle allows clamping each time the corresponding pipe fittings so that the pipe fittings are kept in the receiving opening without the help of any external means during the assembly .

[0066] In a preferred embodiment , the cleaning device has a deflector arranged proximally at a distance from proximal channel openings and overlapping each time at least partially, as seen in a plane perpendicular to the direction of flow of the flushing fluid at the proximal channel openings , the proximal channel openings . In this manner, the deflector deflects flushing fluid in a direction with a radially inwards component , to an optical element of the elongate medical instrument . Preferably the deflector is in the form of a deflector plate for its simple production .

[0067] In a preferred embodiment , the deflector plate is arranged in a plane perpendicular to the direction of flow of the flushing fluid at the proximal channel openings , i . e . perpendicular to the axis of the channels . To ease demolding in case it is produced by inj ection molding, the deflector plate can be arranged in a plane inclined in the direction from distal to proximal by an angle of 0 . 5 ° to 3 ° with respect to the cleaning head proximal face . Most preferably, the angle is 1 ° . This angle range allows an optimi zed distribution of flushing fluid while allowing an easier demolding of the cleaning head proximal face and the deflector plate i f the cleaning head is produced by inj ection molding .

[0068] In a preferred embodiment , the cleaning head is shaped in the form of an opened ring having a ring opening extending circumferentially and a thickened region, preferably in the form of a crescent , the thickened region being arranged diametrically opposed to the ring opening, and in that the plurality of channels are formed in the thickened region . The ring opening improves the field of vision of the operator in the direction of the ring opening when the elongate medical instrument has an optical element arranged at the proximal end . The ring opening can also allow the passage of at least a portion of the proximal end of the elongate medical instrument that can protrude further than the cleaning head proximal face . The thickened region allows the arrangement of channels in the cleaning head .

[0069] In a preferred embodiment , inj ection channels o f the plurality of inj ection channels have each time a recess extending radially from the receiving portion in direction to the inj ection opening and in fluid communication with the cleaning head distal face to allow the formation of a contact surface of the adhesive agent in the inj ection channel with the proximal end of the corresponding tube . The recess in the inj ection channels allows each time a fluid communication between the inj ection channels and the cleaning head distal face . In the assembled state , the proximal end of the tubes and the cleaning head distal face are flush so that the adhesive agent flowing each time through the recesses during inj ection has an increased contact surface with the tubes . The resistance of the assembly to traction is further improved .

[0070] In a preferred embodiment , the plurality of tubes are embedded in a connection tube designed to receive the elongate medical instrument . The connection tube comprising the plurality of tubes simpli fies the assembly of the cleaning device . Indeed, the plurality tubes are kept in a fixed position and the number of parts to assemble is reduced . The connection tube extends from the plurality of channels to the source of flushing fluid and to the suction source , wherein the arrangement of the plurality of tubes in the connection tube is kept to connect them to the source of flushing fluid or to the suction source .

[0071] In a more preferred embodiment , the connection tube has a cross section is shaped in the form of a ring and has a tube thickened region, preferably in the form of a crescent , wherein the plurality of channels are embedded in the tube thickened region . The tube thickened region is arranged to allow the connection of corresponding channels and tube . This embodiment is designed to be used with the cleaning head shaped in the form of an opened ring disclosed above , while the elongate medical instrument can be inserted in the connection tube to further improve the fixation of the cleaning device to the elongate medical instrument .

[0072] In a preferred embodiment , the method comprises further the step of providing a hub having a flushing fluid port designed to be connected with the source of flushing fluid and a suction source port designed to be connected with the suction source , the hub further having a hub mounting interface arranged on a hub proximal face and formed symmetrically to the cleaning head mounting interface with respect to a plane perpendicular to the cleaning head longitudinal axis . In addition, the method comprises also the step of connecting the plurality of tubes to the hub mounting interface on their side opposed to the cleaning head each time by way of a pipe fitting in a manner corresponding to the connection of the plurality of tubes to the cleaning head mounting interface . The use of the hub allows a simple connection of the plurality of tubes to the source of flushing fluid and the suction source because only two ports instead of a plurality of tubes must be connected . This arrangement simpli fies the assembly of the cleaning device because the connection of the plurality of tubes to the hub has the same advantages as the connection of the plurality of tubes to the cleaning head .

[0073] In a preferred embodiment , a first group of channels formed by channels connected to the source of flushing fluid and a second group of channels formed by channels connected to the suction source , the first group of channels being arranged symmetrically to a longitudinal plane forming a symmetry plane of the cleaning head, preferably the first group of channels being arranged in a first cleaning head region free of channels of the second group, channels of the second group being arranged at a circumferential distance of the first cleaning head region.

[0074] In a preferred embodiment, a viscosity of the adhesive agent lower than 500 mPa.s, preferably lower than 100 mPa.s, most preferably between 30 mPa.s and 90 mPa.s. The range of viscosity allows creating a capillarity effect acting on the adhesive agent, in particular when the distal channel opening has a receiving diameter that is 0.03 mm to 0.20 mm, preferably 0.05 mm to 0.1 mm, larger that the outer diameter of the pipe fitting .

[0075] In a preferred embodiment, the cleaning head is produced by injection molding to allow lower production costs.

[0076] In a preferred embodiment, the cleaning head and the plurality of tubes are made each of a material transmitting wavelength in the range of 300 nm to 410 nm to allow UV light curing of the adhesive agent, preferably 365 nm, 375 nm and 405 nm.

[0077] Description of the figures

[0078] The present invention will be explained in more detail in the following description with reference to the accompanying schematic drawings illustrating the steps of the method to produce the cleaning device according to the embodiment disclosed in Fig . 1 . The features of the cleaning device are thereby also illustrated in the subsequent figures .

[0079] Fig . 1 shows a perspective of a cleaning device according to a first embodiment of the invention mounted on an elongate medical instrument ;

[0080] Fig . 2 shows a perspective of a cleaning head of the cleaning device according to Fig . 1 ;

[0081] Fig . 3 shows the distal side of the cleaning head represented in Fig . 2 ;

[0082] Fig . 4 shows a longitudinal section of the cleaning head represented in Fig . 2 and of a pipe fitting to be inserted in the cleaning head;

[0083] Fig . 5 shows a longitudinal section of a part of a receiving portion of the cleaning head represented in Fig . 2 , wherein the pipe fitting is inserted;

[0084] Fig . 6 shows a perspective view of the cleaning head represented in Fig . 2 with pipe fittings inserted in the cleaning head and a connection tube to be connected to the cleaning head;

[0085] Fig. 7 shows a longitudinal section of the cleaning head represented in Fig. 2, wherein the pipe fitting is inserted, and the tube is connected;

[0086] Fig. 8 shows a perspective view of the assembly of Fig. 7;

[0087] Fig. 9 shows the step of injecting adhesive agent in the assembly of Fig. 7;

[0088] Fig. 10 shows a longitudinal section of a portion of the assembly of Fig. 7, wherein the adhesive agent is cured;

[0089] Fig. 11 shows the cleaning head of Fig. 2 assembled with the connecting tube, wherein a hub is to be connected to the distal end of the tube; and

[0090] Fig. 12 shows the connection tube connected with the hub of Fig. 11.

[0091] A cleaning device 10 to flush a surgical site and suction fluid from the surgical site mounted circumferentially around an elongate medical instrument 20, presently an endoscopic device, having an optical element 22 arranged at the proximal end, is disclosed in Fig. 1.

[0092] A method to produce the cleaning device 10 comprises the step of providing a cleaning head 30 shaped in the form of a ring extending along a cleaning head longitudinal axis 40 and designed to receive a proximal end of the elongate medical instrument 20 .

[0093] The cleaning head 30 comprises a plurality of channels 50 , here four channels , extending each from a proximal channel opening 60 formed in a cleaning head proximal face 70 and a distal channel opening 80 formed in a cleaning head distal face 90 as illustrated in Fig . 2 and Fig . 3 .

[0094] The cleaning head 30 is shaped in the form o f an opened ring having a ring opening 250 extending circumferentially and a thickened region 260 in the form of a crescent , the thickened region being arranged diametrically opposed to the ring opening 250 . The plurality of channels 50 are formed in the thickened region 260 . A first group of channels , here two channels , formed by channels connected to the source 110 of flushing fluid and a second group of channels , here also two channels , formed by channels connected to the suction source 120 are provided .

[0095] The first group of channels is arranged symmetrically to a longitudinal plane forming a symmetry plane of the cleaning head 30 . The first group of channels is arranged in a first cleaning head region free of channels of the second group and the channels of the second group are arranged at a circumferential distance on both side of the first region . The first group of channels have a greater receiving diameter than the second group of channels . Further, a plurality of tubes 100 of the cleaning device are provided, each tube 100 of the plurality of tubes being designed to connect a corresponding channel of the plurality of channels to a source of flushing fluid 110 or to a suction source 120 shown in Fig . 11 . The plurality of tubes 100 are embedded in a connection tube 280 designed to receive the elongate medical instrument 20 . The connection tube 280 has a cross section shaped in the form of a ring and has a tube thickened region in the form of a crescent , wherein the plurality of channels are embedded in the tube thickened region . In other words , the cross section is formed to match the form of the cleaning head distal face 90 to allow a flush contact .

[0096] Further, the method comprises the step of connecting each tube 100 of the plurality of tubes to a corresponding channel 50 of the plurality of channel s .

[0097] For this purpose , a plurality of pipe fittings 130 are provided in a further step represented in Fig . 4 , each pipe fitting being designed to be inserted on its proximal side in a corresponding channel 50 of the plurality of channels and on its distal side in a corresponding tube 100 of the plurality of tubes to connect fluidly the corresponding channel and the corresponding tube .

[0098] Further, the method comprises the step of inserting a proximal section 140 of each pipe fitting in a receiving portion 150 formed by a portion of the corresponding channel 50 as shown in the detailed Fig . 5 , wherein the receiving portion is part of a mounting interface 160 of the cleaning head .

[0099] Referring to Fig . 4 and Fig . 5 , the receiving portion 150 has a f rustoconical shape with a receiving conical angle of 3 ° , the diameter of the receiving portion tapering each time in the direction from distal to proximal from the distal channel opening having a receiving diameter DI greater than an outer diameter D of the corresponding pipe fitting to a proximal end of the receiving portion having an end diameter D3 equal to the outer diameter D of the corresponding pipe fitting . As a result , the pipe fittings abut each time in the receiving portion . The mounting interface 160 further includes an abutment portion 236 having a f rustoconical shape with an abutment conical angle of 1 . 5 ° and formed by a portion of the corresponding channel 50 and arranged in a coaxial extension of the receiving portion 150 proximally adj acent to the receiving portion . The abutment portion 236 has a diameter at its distal end equal to the end diameter D3 of the receiving portion and a diameter D4 at its proximal end smaller than the outer diameter of the pipe fitting . The abutment portion forms , in the inserted state of a proximal end of the pipe fitting, a circumferential abutment delimiting proximally a first interstice 170 extending circumferentially between the receiving portion 150 and the pipe fitting 130 . In the present embodiment , the proximal end of the abutment portion also forms the proximal channel opening 60 .

[0100] The receiving portion comprises a guiding portion 234 having also a f rustoconical shape with a guiding conical angle smaller than the receiving conical angle and arranged distally adj acent to the abutment portion 236 . The guiding conical angle is approximately 0 , 5 ° to clamp the pipe fitting in the guiding portion while allowing the insertion of the pipe fitting . For this purpose , a proximal end of the guiding portion 234 corresponds to the proximal end of the receiving portion 150 , wherein a proximal end diameter of the guiding portion is the same as the end diameter D3 of the receiving portion . A distal end diameter D2 of a distal end of the guiding portion is smaller than the receiving diameter D .

[0101] The receiving portion 150 is arranged in each channel adj acent to its distal channel opening 80 . Depending on the exact outer diameter of the corresponding pipe fitting that are inherent to the production of the pipe fittings , the circumferential abutment will be formed more distally for a larger outer diameter or more proximally for a smaller outer diameter .

[0102] The cleaning device 10 has a deflector 240 in the form of a deflector plate , arranged proximally at a distance from two proximal channel openings 60 . The deflector overlaps each time completely, as seen in a plane perpendicular to the direction of flow of the flushing fluid at the proximal channel openings , the proximal channel openings to def lect flushing fluid in a direction with a radially inwards component , to the optical element of the elongate medical instrument represented in dotted lines in Fig . 7 . The deflector 240 is arranged in a plane inclined in the direction from distal to proximal by an angle of 0 . 5 ° with respect to the cleaning head proximal face to allow an easier demolding of the cleaning head proximal face and the deflector plate produced by inj ection molding .

[0103] Further, the cleaning head 30 is shaped in the form of a ring, thereby delimiting a receiving inner space 244 for the proximal end of the elongate medical instrument and the receiving inner space forms a cleaning head opening in the cleaning head proximal face 70 for the proximal end of the elongate medical instrument . The cleaning head has a radial abutment 245 proj ecting radially in the receiving inner space to block the insertion in the cleaning head of the proximal end of the elongate medical instrument . The radial abutment 245 is arranged adj acent to the cleaning head proximal face 70 and comprises a first abutment element 246 proj ecting from the cleaning head in the receiving inner space perpendicular to the cleaning head longitudinal axis and a second abutment element 247 proj ecting from the first abutment element 246 , wherein the distal surface of the second abutment element is inclined by an angle of 30 ° with respect to the cleaning head longitudinal axis .

[0104] Fig . 6 illustrates a further step of inserting a distal section 180 of each pipe fitting in the corresponding tube 100 to connect fluidly the corresponding channel 50 and the corresponding tube 100 , thereby forming a second interstice 190 extending circumferentially between the tube and the pipe fitting 130 in an inserted state of the distal end of the pipe fitting .

[0105] In the inserted state as illustrated in Fig . 7 , the distal channel opening 80 of the corresponding channel abuts a proximal end of the corresponding tube 100 , the tube having a tube inner diameter designed to form the second interstice 190 extending circumferentially between the tube 100 and the pipe fitting 130 . The tube inner diameter is configured such that the pipe fitting can be inserted slidingly in the tube , while allowing creation of a capillarity ef fect between the pipe fitting and the tube when an adhesive agent is inj ected in the second interstice .

[0106] In addition, as illustrated in Fig . 8 and Fig . 9 , the method comprises the step of inj ecting in each inj ection channel 210 of a plurality of inj ection channels included in the mounting interface 160 the adhesive agent 220 through the inj ection channel under the ef fect of capillarity into the first interstice 170 and further into the second interstice 190 . After curing of the adhesive agent , the tube is fastened in a sealed manner with the cleaning head . Each inj ection channel extends radially outwards from the receiving portion 150 of a channel of the plurality of channel s to an inj ection opening 230 of the inj ection channel .

[0107] The first interstice 180 and the second interstice 190 form an intervening space that is dimensioned to create a capillarity ef fect acting on the adhesive agent 220 that is inj ected in the intervening space , resulting in adhesive agent spreading circumferentially along the pipe fitting outer envelope distally and proximally from the inj ection channel . The inj ection channels 210 have each time a recess 270 extending radially from the receiving portion 150 in direction to the inj ection opening 230 and in fluid communication with the cleaning head distal face 90 to allow the formation of a contact surface of the adhesive agent 220 in the inj ection channel 210 with the proximal end of the corresponding tube . The recess 270 in the inj ection channels 210 allows each time a fluid communication between the inj ection channels 210 and the cleaning head distal face 90 . In the assembled state , the proximal end of the tubes and the cleaning head distal face are flush so that the adhesive agent flowing each time through the recesses during inj ection has an increased contact surface with the tubes . Fig . 10 illustrates the step in which the adhesive agent 220 is cured .

[0108] The plurality of tubes 100 are embedded in a connection tube 280 designed to receive the elongate medical instrument . The connection tube 280 extends from the plurality of channels to the source of flushing fluid 110 and to the suction source 120 .

[0109] As shown in Fig . 11 and Fig . 12 , the method comprises further the step of providing a hub 290 having a flushing fluid port 300 designed to be connected with the source of flushing fluid 110 schematically represented and a suction source port 310 designed to be connected with the suction source 120 schematically represented . The hub 290 further has a hub mounting interface 320 arranged on a hub proximal face 330 and formed symmetrically to the cleaning head mounting interface 160 with respect to a plane perpendicular to the cleaning head longitudinal axis . The next step is connecting the plurality of tubes 100 to the hub mounting interface 320 on their side opposed to the cleaning head each time by way of a pipe fitting 130 in a manner corresponding to the connection of the plurality of tubes to the cleaning head mounting interface .

[0110] List of reference number cleaning device 10 elongate medical instrument 20 optical element 22 cleaning head 30 cleaning head longitudinal axis 40 channels 50 proximal channel opening 60 cleaning head proximal face 70 distal channel opening 80 cleaning head distal face 90 tubes 100 source of flushing fluid 110 suction source 120 pipe fittings 130 proximal section of a pipe fitting 140 receiving portion 150 mounting interface 160 first interstice 170 distal section of pipe fitting 180 second interstice 190 proximal end of tube 200 inj ection channels 210 adhesive agent 220 inj ection opening of inj ection channel 230 guiding portion 234 abutment portion 236 deflector 240 receiving inner space 244 radial abutment 245 first abutment element 246 second abutment element 247 ring opening 250 thickened region 260 recess 270 connection tube 280 hub 290 flushing fluid port 300 suction source port 310 hub mounting interface 320 hub proximal face 330 outer diameter of the pipe fitting D receiving diameter of the receiving portion DI distal end diameter of the guiding portion D2 end diameter of the receiving portion D3 diameter at proximal end of abutment portion D4

Claims

Claims1. Method to produce a cleaning device (10) to flush a surgical site and suction fluid from the surgical site suitable for being mounted circumferentially around an elongate medical instrument (20) , in particular an endoscopic device, the method comprising the steps of a) providing a cleaning head (30) shaped in the form of a ring extending along a cleaning head longitudinal axis (40) and designed to receive a proximal end of the elongate medical instrument (20) ; the cleaning head comprising a plurality of channels (50) extending each from a proximal channel opening (60) formed in a cleaning head proximal face (70) and a distal channel opening (80) formed in a cleaning head distal face (90) , and further providing a plurality of tubes (100) , each tube (100) of the plurality of tubes being designed to connect a corresponding channel (50) of the plurality of channels to a source of flushing fluid (110) or to a suction source (120) ; and b) connecting each tube (100) of the plurality of tubes to a corresponding channel (50) of the plurality of channels;characterized by the steps of c) providing a plurality of pipe fittings (130) , each pipe fitting (130) being designed to be inserted on its proximal side in a corresponding channel (50) of the plurality of channels and on its distal side in a corresponding tube (100) of the plurality of tubes to connect fluidly the corresponding channel (50) and the corresponding tube (100) ; d) inserting a proximal section (140) of each pipe fitting (130) in a receiving portion (150) formed by a portion of the corresponding channel, the receiving portion (150) being part of a mounting interface (160) of the cleaning head, a first interstice (170) extending circumferentially between the receiving portion (150) and the pipe fitting (130) being formed in the inserted state of a proximal end of the pipe fitting, the receiving portion (150) being arranged in each channel (50) adjacent to its distal channel opening (80) ; e) inserting a distal section (180) of each pipe fitting (130) in the corresponding tube (100) to connect fluidly the corresponding channel (50) and the corresponding tube (100) , thereby forming a second interstice (190) extending circumferentially between the tube (100) and the pipe fitting (130) in an inserted state of the distal end (180) of the pipefitting, in which the distal channel opening (80) of the corresponding channel abuts a proximal end (200) of the corresponding tube, the tube (100) having a tube inner diameter designed to form the second interstice (190) extending circumferentially between the tube (100) and the pipe fitting (130) ; f) injecting an adhesive agent (220) under the effect of capillarity into the first interstice (170) and further into the second interstice (190) , the tube (100) being fastened in a sealed manner with the cleaning head (30) after curing of the adhesive agent (220) .

2. Method according to claim 1, characterized in that in step d) , the receiving portion (150) has a f rustoconical shape with a receiving conical angle, the diameter of the receiving portion (150) tapering each time in the direction from distal to proximal from the distal channel opening having a receiving diameter (DI) greater than an outer diameter (D) of the corresponding pipe fitting (130) to a proximal end of the receiving portion (150) having an end diameter (D3) equal to the outer diameter (D) of the corresponding pipe fitting (130) ; wherein the mounting interface (160) further includes an abutment portion (236) formed by a portion of the corresponding channel and arranged in a coaxial extension of the receivingportion proximally adjacent to the receiving portion, the abutment portion (236) having a diameter at its distal end equal to the end diameter (D3) of the receiving portion and a diameter (D4) at its proximal end smaller than the outer diameter (D) of the pipe fitting to form, in the inserted state of a proximal end of the pipe fitting, a circumferential abutment delimiting proximally a first interstice (170) extending circumferentially between the receiving portion (150) and the pipe fitting (130) , the receiving portion (150) being arranged in each channel (50) adjacent to its distal channel opening (80) .

3. Method according to claim 1 or 2, characterized in that in step f) the adhesive agent is injected in each injection channel (210) of a plurality of injection channels included in the mounting interface (160) into the first interstice (170) and further into the second interstice (190) under the effect of capillarity, preferably each injection channel (210) extending outwards with a radial component from the receiving portion (150) of a channel of the plurality of channels to an injection opening (230) of the injection channel.

4. Method according to any one of claims 1 to 3, characterized in that the step d) of inserting the proximal section (140) of each pipe fitting (130) in the receivingportion (150) of the corresponding channel further comprises the step dl) of inserting the proximal section (140) of each pipe fitting (130) in a guiding portion (234) comprised in the receiving portion (150) , the guiding portion (234) having a f rustoconical shape with a guiding conical angle smaller than the receiving conical angle, the guiding portion (234) being arranged distally adjacent to the abutment portion (236) .

5. Method according to any one of claims 1 to 4, characterized in that the cleaning device has a deflector (240) , preferably in the form of a deflector plate, arranged proximally at a distance from proximal channel openings (60) and overlapping each time at least partially, as seen in a plane perpendicular to the direction of flow of the flushing fluid at the proximal channel openings (60) , the proximal channel openings to deflect flushing fluid in a direction with a radially inwards component, to an optical element of the elongate medical instrument (20) .

6. Method according to any one of claims 1 to 5, characterized in that the cleaning head is shaped in the form of an opened ring having a ring opening (250) extending circumferentially and a thickened region (260) , preferably in the form of a crescent, the thickened region (260) being arranged diametrically opposed to the ring opening (250) , andin that the plurality of channels (50) are formed in the thickened region (260) .

7. Method according to any one of claims 1 to 4, characterized in that injection channels (210) of the plurality of injection channels have each time a recess (270) extending radially from the receiving portion (150) in direction to the injection opening (230) and in fluid communication with the cleaning head distal face (90) to allow the formation of a contact surface of the adhesive agent (220) in the injection channel (210) with the proximal end (200) of the corresponding tube .

8. Method according to any one of claims 1 to 7, characterized by a first group of channels formed by channels (50) connected to the source of flushing fluid (110) and a second group of channels formed by channels (50) connected to the suction source (120) , the first group of channels being arranged symmetrically to a longitudinal plane forming a symmetry plane of the cleaning head (30) , preferably the first group of channels (50) being arranged in a first cleaning head region free of channels of the second group, channels of the second group being arranged at a circumferential distance of the first cleaning head region.

9. Cleaning device (10) to flush a surgical site and suction fluid from the surgical site suitable for being mounted circumferentially around an elongate medical instrument (20) , in particular an endoscopic device, the cleaning device comprising a cleaning head (30) shaped in the form of a ring extending along a cleaning head longitudinal axis (40) and designed to receive a proximal end of the elongate medical instrument; the cleaning head comprising a plurality of channels (50) extending each from a proximal channel opening (60) formed in a cleaning head proximal face (70) and a distal channel opening (80) formed in a cleaning head distal face (90) , and the cleaning device (10) further comprising a plurality of tubes (100) , each tube (100) of the plurality of tubes connecting a corresponding channel (50) of the plurality of channels to a source of flushing fluid (110) or to a suction source (120) , and characterized in that the cleaning device (10) comprises a plurality of pipe fittings (130) , each pipe fitting (130) being inserted on its proximal side in a corresponding channel (50) of the plurality ofchannels and on its distal side in a corresponding tube (100) of the plurality of tubes to connect fluidly the corresponding channel (50) and the corresponding tube (100) ; the tube has a tube inner diameter forming a second interstice(190) extending circumferentially between the tube (100) and the pipe fitting (130) in the inserted state of the distal end of the pipe fitting; and the cleaning head (30) comprises a mounting interface (160) including a receiving portion (150) formed by a portion of the channel arranged adjacent to its distal channel opening (80) and designed to receive the pipe fitting (130) corresponding to the channel; wherein, in the inserted state of a proximal end of the pipe fitting, a first interstice (170) extending circumferentially between the receiving portion (150) and the pipe fitting (130) is present.

10. Cleaning device (10) according to claim 9, characterized in that the receiving portion (150) has a f rustoconical shape with a receiving conical angle, the diameter of the receiving portion tapering each time in the direction from distal to proximal, from the distal channel opening (80) having a receiving diameter (DI) greater than the outer diameter (D) of the corresponding pipe fitting (130) to a proximal end of thereceiving portion (150) having an end diameter (D3) equal to the outer diameter (D) of the corresponding pipe fitting, the mounting interface (160) further including an abutment portion (236) formed by a portion of the corresponding channel and arranged in a coaxial extension of the receiving portion proximally adjacent to the receiving portion, the abutment portion (236) having a diameter at its distal end equal to the end diameter (D3) and a diameter (D4) at its proximal end smaller than the outer diameter (D) of the pipe fitting (130) to form, in the inserted state of a proximal end of the pipe fitting, a circumferential abutment delimiting proximally a first interstice (170) extending circumferentially between the receiving portion (150) and the pipe fitting (130) .

11. Cleaning device (10) according to claim 9 or 10, characterized in that the receiving portion (150) comprises a guiding portion (234) having a f rustoconical shape with a guiding conical angle smaller than the receiving conical angle, the guiding portion (234) being arranged distally adjacent to the abutment portion (236) .

12. Cleaning device (10) according to any one of claims 9 to 11, characterized in that the mounting interface (160) further includes a plurality of injection channels (210) , an injection channel (210) of the plurality of channels extending each timeoutwards with a radial component from the receiving portion (150) of a channel of the plurality of channels to an injection opening (230) and being each time designed to allow the injection of an adhesive agent (220) through the injection channel (210) into the first interstice (170) and further into the second interstice (190) , the tube (100) being fastened in a sealed manner with the cleaning head (30) after curing of the adhesive agent.

13. Cleaning device (10) according to any one of claims 9 to 12 characterized by a deflector (240) , preferably in the form of a deflector plate, arranged proximally at a distance from proximal channel openings (60) and overlapping each time at least partially, as seen in a plane perpendicular to the direction of flow of the flushing fluid at the proximal channel openings, the proximal channel openings (60) to deflect flushing fluid in a direction with a radially inwards component, to an optical element arranged at the proximal end of the elongate medical instrument (20) .

14. Cleaning device (10) according to any one of claims 9 to 13, characterized in that the cleaning head (30) is shaped in the form of an opened ring having a ring opening (250) circumferentially and a thickened region (260) , preferably in the form of a crescent, the thickened region (260) beingarranged diametrically opposed to the ring opening (250) , and in that the plurality of channels are formed in the thickened region (260) .

15. Cleaning device (10) according to any one of claims 9 to 14, characterized in that injection channels (210) of the plurality of injection channels have each time a recess (270) extending radially from the receiving portion (150) in direction to the injection opening (230) and in fluid communication with the cleaning head distal face (90) to allow the formation of a contact surface of the adhesive agent (220) in the injection channel (210) with the proximal end (200) of the corresponding tube.

Images