WO2023002365A1

WO2023002365A1 - Minimally invasive device for endoscopic treatment.

Info

Publication number: WO2023002365A1
Application number: PCT/IB2022/056640
Authority: WO
Inventors: Filippo NIGRO; Maurizio CASAROTTO
Original assignee: Fmp Biotechnologies S.R.L.
Priority date: 2021-07-20
Filing date: 2022-07-19
Publication date: 2023-01-26

Abstract

Invasive device (2) for endoscopic treatment, preferably for endourological treatment, comprising a tubular duct (4), flexible longitudinally, intended to be inserted and crossed the channel (8) of an endoscope (10), said tubular duct (4) internally delimits an intake duct and includes: - a central portion (6) intended to pass through the operating channel (8) of the endoscope (10), - a portion (12) which in operation is the distal one and which is intended to come out, at least in part, from the distal tip (21) of the endoscope (10), inserted in the patient's body, and this in order to reach the target to be taken and/or withheld, - a proximal portion (14) which is opposite to said distal portion (12), and characterized in that it comprises: - a connection unit (40) which is configured to be fixed to an endoscope (10) or to be integrated in an endoscope (10) and which is traversed, at least in part, by said proximal portion (14), - means (55) which are operatively associated with the end and/or proximal portion (14) of said tubular duct (4) and which are movable with respect to the connection unit (40) to vary the length of the distal portion (12) of the tubular duct (4) protruding from the distal tip (21) of the endoscope (10), - a first connector (43) for the mechanical and fluidic connection to suction means (93).

Description

MINIMALLY INVASIVE DEVICE FOR ENDOSCOPIC TREATMENT. FIELD OF THE TECHNIQUE

The present invention relates to a minimally invasive device for endoscopic treatments, preferably for endourological treatments. STATE OF THE ART

At present, the endourological treatment of urinary stones involves the introduction, within the operative channel of specific endoscopes, of tools useful for the treatment of the stones itself. These tools are essentially divided into two types: those aimed at reducing the stone into a series of fragments of dimensions suitable for natural extraction by the human body, and those aimed at mobilizing the stone itself or direct extraction of the fragments.

Among this second type of device there are the pliers specifically designed to grasp the fragments of the stone. In particular, the wider endoscopes, with a rigid structure, allow the use of very large forceps, which are particularly effective in terms of gripping and extraction. Furthermore, even the small-sized endoscopes, with a flexible structure, allow the passage of small-sized forceps inside their operating channel.

Although the pliers are economically advantageous as, after sterilization, they can be reused, they are however ineffective in most cases. In particular, the pincers, precisely because of their specific conformation, as well as because of the material they are made of, once introduced into the endoscope, cause the latter to stiffen and reduce its flexibility. This considerably compromises the effectiveness of the endoscope itself, limiting its ability to reach the peripheral areas of the urinary tract, in particular in cases where the target stone is "off axis", ie misaligned with respect to the entrance to the endoscope.

Furthermore, the operation of the gripper is compromised beyond a certain curvature of the same. In particular, once a certain limit value has been exceeded, the angle of the supporting structure compromises the transmission of the mechanical command from the handpiece to the pliers tie rods, thus preventing opening the mouth of the same.

As an alternative to the pliers, the so-called "baskets" or containers are also known among the devices aimed at mobilizing the stone and/or directly extracting its fragments. These are particularly thin and flexible devices, which can always be introduced into the body through the operating channel of the endoscope. They can be operated through an external handpiece which controls the opening of metal coils on the lithiasic fragment. In particular, these coils, closing like a net on the target stone fragment, wrap it in such a way as to allow it to be mobilized or extracted. The basket devices overcome all the drawbacks of the pliers since, having a thinner structure, they compromise to a lesser extent the flexibility of the endoscope into which they are introduced. Moreover, unlike the pliers, they are able to open on the target even in conditions of considerable angle. However, the basket devices are not completely satisfactory either. First, being single-use devices, they add a specific cost to each surgical procedure. Furthermore, it is often difficult to block the stone fragment inside the coils, either because it is too bulky to be completely wrapped by the coils or, on the contrary, because the fragments are so small that they protrude between the coils, while the coils themselves they close. Basically, the basket devices cannot be used for the removal of particularly large or particularly small stone fragments.

A further drawback relates to the operational difficulty linked to the impossibility of wrapping the stone when it is off-axis with respect to the opening of the basket coils.

Furthermore, after a few steps and attempts to remove the lithiasic fragments, the functioning of the basket is compromised, and this can lead to an extreme difficulty in releasing the stone fragment, once it has been grasped, in the event that it is considered too voluminous to be extracted whole. Therefore, if the operation of the basket device is compromised, it must inevitably be replaced, with further economic expenditure. Furthermore, the endoscopic maneuvers necessary to resolve this complication can be complex and in turn lead to further clinical complications.

Ultimately, all these technical and operational difficulties of the basket device entail an extension of the operating times.

US 2004/0019358 discloses a device which comprises an elongated element defining a hollow suction duct. In particular, this elongated element is longitudinally flexible, is configured to be inserted inside the operating channel of a urethroscope and is also capable of resisting the deformations caused by aspiration. More in detail, the proximal portion of the elongated element is in communication with a vacuum source capable of providing suction inside the duct, while the distal portion of the elongated element itself protrudes from the urethroscope and is intended to enter in contact with the object to be treated in the patient's body. US 2004/0019358 describes in detail the use of the elongated element to capture, hold, move/remove a kidney stone when the latter is embedded in a tissue or is positioned in a part of the patient's body that is difficult to access by traditional instruments (basket or gripper). However, in all these applications, it is provided that the duct, defined inside the elongated element, always and only acts as a suction duct. In fact, US 2004/0019358 teaches at most to withdraw the elongated element from the urethroscope and to insert inside the urethroscope itself, as an alternative to the elongated element defining the suction duct, another surgical instrument for removing the stone.

US 5102415, WO 99/45835, US 2002/188313 and WO 2012/156924 relate to devices used in a cardiological and non-endourological context. In particular, in the cardiological context the use of the endoscope is not envisaged and, therefore, the technical problems are different from those of the endourological context, in which the use of the endoscope is instead foreseen.

US 6375651 discloses a device which comprises a suction duct and an energy transmission duct, which can be co-extruded, attached or separated from each other, or one inside the other. Furthermore, a plurality of components, such as laser fibers, optical fibers, catheters and guide wires, can be housed inside the device casing. However, in all the embodiments described in US 6375651, there are always two ducts, one for the suction and one for the laser fiber, which are separated from each other. In particular, the laser fiber duct can also be positioned inside the suction duct, but in any case they must be separated. Last but not least, the fact that the external tubular casing, inside which the suction duct and the duct for the laser are separately obtained, internally have a particularly thick circular crown which has a particularly reduced longitudinally flexibility.

US 7540868 describes a device provided with an elongated element connected to a suction tube and inside which a laser fiber is inserted which is fixed with a clip in correspondence with the distal portion of the elongated element. The presence of the clip does not allow the removable insertion of the laser fiber and, in any case, does not allow the removable insertion of other grasping tools, such as the forceps or the basket, used in endourological treatments. Furthermore, US 7540868 requires that the elongated member be connected with the suction connector by means of a suction tube, which is housed within the enclosure of the device. Last but not least the fact that the elongated element of US 7540868 does not have an internally non-deformable lumen.

US4692139 discloses a catheter for removing obstructions present in a biological channel which comprises an insertion sleeve (and not an endoscope) inside which a flexible aspiration tube is inserted which is connected with its proximal end to a source of aspiration. Furthermore, a small tube for the injection of medical substances and an ultrasound probe is inserted inside the suction tube. In this solution, the suction pipe has a male thread on the external surface which cooperates and engages a corresponding female thread which is provided on the internal surface of the insertion sleeve and this in order to allow a controlled sliding of the suction pipe inside the sleeve. Furthermore, a locking ring of the distal end of the suction tube is provided at the distal tip of the sleeve in order to prevent the latter from escaping beyond the distal tip of the sleeve itself. US5417697 describes a solution for the removal of a polyp present inside the colon of a patient. This solution comprises an endoscopic surgical device with an elongated tubular duct that can be inserted inside an endoscope channel. In particular, at its distal end, the tubular duct is provided with a cup-shaped portion from which a cauterization ring emerges which is supplied with electric current to sever the polyp from the patient. Furthermore, the tubular duct is provided with suction to allow the severed polyp to enter the duct itself. As can be seen from the figures, the tubular duct of US5417697 does not have a substantially non-deformable lumen, but rather must be deformable in order to allow the cut polyp to enter. DE 19842113 describes a solution for the extraction of stents or thrombi from blood vessels. This solution comprises a first extraction catheter, which is formed by a tubular duct provided at its distal tip with three expandable portions which open to define a funnel. In particular, this extraction catheter is inserted and internally passes through a second introduction catheter, so that the tip of the first opens like a funnel when it comes out of the latter. More in detail, the second introduction catheter consists of a cover sleeve, which is shorter in length than the extraction catheter, and which slides along the latter. It is also possible to aspirate the thrombus inside the extraction catheter and this necessarily means that the lumen of this catheter must be deformable.

US5417697 and DE19842113 do not describe devices for endourological treatment and, in particular, it is evident how the deformability of the lumen of the tubular duct of US5417697 or of the extraction catheter of DE 19842113 makes these solutions unsuitable and in any case incompatible with the needs and values of aspiration required in the endourological field, for example to capture and mobilize stones.

WO201 7203462 describes a minimally invasive device for endourological treatment which comprises a tubular duct, flexible longitudinally, intended to be inserted in and through the operative channel of an endoscope. The tubular duct internally defines a substantially non-deformable lumen and constitutes a suction duct inside which at least one instrument used in endourological treatment can be inserted in a removable way. The tubular duct has a proximal portion for connection with the suction means and a distal portion which is intended to protrude from the distal end of said endoscope.

US6051008 discloses an apparatus for performing percutaneous surgical interventions inside an organ or a vessel. In particular, the apparatus comprises a catheter formed by a bearing structure and a guided element which has an end portion which is movable between a position parallel to the longitudinal axis of the bearing structure and a working position in which it is substantially orthogonal with respect to said axis. A terminal actuator comprising a rotating cutting head and an actuation mechanism is mounted at the end portion of the guided element. A control wire is inserted inside the lumen of the guided element to cause the movement, and in particular the curvature, of the terminal portion of the guided element and a further tubular duct is also inserted which is connected to the rotating cutting head. The apparatus also comprises a handle assembly with a lower portion connected to the supporting structure of the catheter and an upper portion connected to the guided element, where the upper portion is slidingly engaged on the lower portion so as to cause the longitudinal translation of the guided element with respect to the supporting structure. On the upper portion of the handle assembly a movable lever is mounted inside a slot to thus control the exit of the cutting head from the end portion of the guided element. Furthermore, a cable protrudes from the upper portion of the handle assembly for connecting the terminal portion of the guided element to a controller provided with a vacuum source.

US2001/025174 describes an apparatus for performing a minimally invasive surgery through an opening obtained in the patient's chest. The apparatus comprises an introducer sleeve, which is entirely longitudinal, and into which a bronchoscope catheter which is connected to a main device of the bronchoscope can be inserted.

US2016/235478 describes a system to be used for the removal of a stone which includes an inner tube and an outer tube, as well as a further tube, which is inserted inside the inner tube and which is equipped at the end with an element for the withholding of the calculation. Furthermore, the system comprises a handle with a fixed portion which is associated with the inner tube and a movable portion which is associated with the outer tube so as to cause movement of the outer tube.

OBJECTIVES OF THE INVENTION

The object of the invention is to obviate all these drawbacks by proposing a minimally invasive device for endoscopic treatment, in particular endourological, which is improved and optimized with respect to traditional devices.

Another object of the invention is to propose a device which, once inserted into the endoscope, allows the surgical operator to modify, in a simple and rapid way and by acting on the device itself, the length of the distal portion of the device that protrudes from the endoscope.

Another object of the invention is to propose a device which overcomes the drawbacks of traditional devices.

Another object of the invention is to improve and optimize the minimally invasive device for the endourological treatment described in WO2017203462. Another object of the invention is to propose a device for gripping, moving and holding a body, such as for example a stone, during a minimally invasive endoscopic treatment.

Another object of the invention is to provide a device suitable to be used in combination with one or more instruments used for endourological treatment, such as a laser source for lithotripsy and/or a grasping instrument and/or a catheter for injection of substances.

Another object of the invention is to provide a device which, despite having small dimensions, is particularly effective, and more specifically is able to reach even the most peripheral districts of the urinary tract.

Another object of the invention is to provide a device which does not hinder the flexibility of the endoscope, inside which it is inserted.

Another object of the invention is to realize a device which has a high accuracy, reliability and safety. Another object of the invention is to provide a device which is multifunctional and which reduces surgical times.

Another object of the invention is to provide a device with an alternative characterization, in terms of construction, functionality and performance, with respect to traditional ones. Another object of the invention is to provide a device which can be obtained simply, quickly and with low costs.

Another object of the invention is to provide an endoscope with an improved and/or alternative characterization, in terms of construction, functionality and performance, with respect to traditional ones. SUMMARY OF THE INVENTION

All these objects, considered individually or in any combination thereof, and others that will result from the following description are achieved, according to the invention, with a device with the characteristics indicated in claim 1 and with an endoscope with the characteristics indicated in claim 10. DESCRIPTION OF THE FIGURES

The present invention is further clarified hereinafter in a preferred embodiment thereof, reported for purely illustrative and non-limiting purposes with reference to the attached drawing tables, in which: figure 1 shows in schematic view of a device according to the invention, figure 2 shows a schematic view of the device of fig. 1 inserted inside the endoscope, figure 3a shows a schematic view of the device of fig. 1 with also the guide for insertion into the endoscope, figure 3b shows a schematic view of the device of fig. 1 with the guide inserted, figure 4a shows an enlarged detail of the device of fig. 1 in a first condition in which the gripping and control member is more inserted inside the connection unit fixed to the endoscope; in this first condition, the distal portion of the tubular duct (not shown in fig. 4a) is more protruding from the distal tip of the endoscope, figure 4b shows an enlarged detail of the device of fig. 1 in a second condition in which the gripping and control member is further extracted from the connection unit fixed to the endoscope; in this second condition, the distal portion of the tubular duct (not shown in fig. 4b) does not protrude or slightly protrudes from the distal tip of the endoscope, figure 5 shows section VV of fig. 4a, figure 6 shows a schematic view of the device according to the invention in a second embodiment, figure 7 shows a schematic view of the device according to the invention in a third embodiment, figure 8 shows a schematic view of the guide only for inserting the device of fig. 6 or 7 inside an endoscope, figure 9 shows a perspective and schematic view of an endoscope according to the invention.

DETAILED DESCRIPTION OF THE INVENTION AND OF SOME OF ITS PREFERRED

EMBODIMENTALS

As can be seen from the figures, the minimally invasive device 2 for endoscopic treatments, in particular for endourological treatments, according to the invention, comprises a tubular duct 4 and a connection unit 40 which is configured to be fixed - or in any case it is configured to be made integral - to an endoscope 10 comprising an operating channel 8 inside which the tubular duct 4 is intended to be inserted.

Conveniently, the connection unit 40 can be connected to the endoscope 10 or, in a possible embodiment not shown here, it can also be integrated into the endoscope 10, and therefore be part of the latter. Conveniently, the connection unit 40 can be fixed directly to the endoscope 10 or it can be fixed (ie made integral) to the latter indirectly, preferably by means of an intermediate connection element. Advantageously, the intermediate connecting element can comprise a "Y" or "T" connector element (i.e. with three terminations) in which a first termination is fixed to the endoscope, a second termination is fixed to the connection unit 40 while the third termination is in mechanical and fluidic connection with irrigation and/or suction means 93. Preferably, the connection unit 40 is sealed with the inside of the tubular duct 4.

In particular, the tubular duct 4 comprises: - a central portion 6 intended to cross the entire operating channel 8 of the endoscope

10,

- a portion 12 which in operation is the distal one and which is intended to protrude, at least in part, from the distal/internal tip 21 of the endoscope 10, inserted in the patient's body, and this in order to be able to reach the target to be taken and/or held, - a portion 14 - which in operation is the proximal one and which is defined at one end of the tubular duct 4 which is opposite to that in which the distal portion 12 is defined - which is intended to come out of the endoscope 10 passing through, at least in part, the connection unit 40.

The device 2 also comprises a (first) first connector 43 for the mechanical and fluidic connection with the suction means 93.

The proximal portion 14 of the tubular duct 4 is in fluidic connection with suction means 93, external to the device 2, but without there being a mechanical connection and/or direct contact between said proximal portion 14 and said suction means 93. In particular, for this purpose, in the device 2 the end and/or proximal portion 14 is not in contact, or in any case is spaced apart, from the first connector 43 for the suction means

93. Conveniently, the suction means 93 comprise a circuit with one or more pipes 92 connected to a vacuum generator 91.

The tubular duct 4 is substantially a catheter. The tubular duct 4 internally delimits a suction duct. In a possible and preferred embodiment, the tubular duct 4 acts - and in particular is configured so as to act - exclusively and only as a suction duct, ie no further instruments are inserted inside it. Preferably, the traditional laser means (preferably comprising a fiber connected to the laser source), for example for lithotripsy, are external to the device 2 and, in particular, pass through the endoscope 10 externally with respect to the tubular duct 4 of the device 2; in more detail, the fiber connected to the laser source, although external to the tubular duct 4 of the device 2, can be inserted inside the same operating channel 8 of the endoscope 10 into which the tubular duct 4 is inserted, or it can be inserted in a dedicated and different channel of the endoscope.

Alternatively, in another possible embodiment, one or more instruments used in endoscopic treatment, for example endourological, can be removably inserted inside the tubular duct 4. Preferably, these instruments can comprise traditional laser means for lithotripsy, a grasping instrument and/or a catheter for injecting substances. Conveniently, the suction duct, which is defined by the tubular duct 4, is configured so that several instruments used in endourological treatment can be inserted simultaneously inside the duct itself or one at a time.

Preferably, the suction duct is entirely and only delimited by the internal walls of the tubular duct 4.

Preferably, the tubular duct 4 of the device 2 has a high longitudinal flexibility, substantially along its entire longitudinal development, and at the same time has a high transversal non-deformability, i.e. it is able to maintain the lumen defined inside it unchanged even when it is subjected to contraction forces, due to internal aspiration, and/or to compression forces, caused by the irrigation flow, which acts on the external surface of the duct itself.

In a preferred and possible embodiment, such as that shown in Figures 1 - 5, the entire tubular duct 4 (ie the central 6, distal 12 and also proximal 14 portion) is made of the same polymeric material. Preferably, the tubular duct 4 is made in a single piece and can be obtained in a single molding or by extrusion. More in detail, preferably, the tubular body that defines the entire tubular duct 4 (ie both the central 6 and distal 12 portions, and the proximal portion 14) is made of an elastomeric thermoplastic material, preferably a block copolymer obtained from polycondensation of a carboxylic acid with a polyamide (PA) and of a polyether (PE) comprising a terminal alcohol group, for example it is in PEBAX®. Conveniently, the tubular duct 4 can be made - preferably by molding or extrusion

- in a single piece.

Preferably, the distal portion 12 is made in a single piece with the central portion 6. Preferably, the distal portion 12 and the central portion 6 are made of the same material.

In some preferred and possible embodiments, such as those shown in Figures 6 and 7, the central portion 6 and the distal portion 12 of the tubular duct 4 are made in a single body and of the same polymeric material, while the proximal portion 14 of the duct 4 it can be made of a different polymeric material. Preferably, the central portion 6 and the distal portion 12 are made in a single piece and are obtained in a single molding or by extrusion. Preferably, the proximal portion 14 can be co-molded together with the central 6 and distal 12 portion, or it can be made separately and then can be joined - by technologies known to the skilled person - to the assembly defined by the central 6 and distal 12 portion. Conveniently, the proximal portion 14 of the tubular duct 4 can be configured so as to be more rigid than the central 6 and distal 12 portion of the tubular duct 4. Preferably, the proximal portion 14 of the tubular duct 4 can be made of a more rigid polymeric material than that with which the central 6 and distal 12 portion of the tubular duct 4 are made. Advantageously, this allows the proximal portion 14 to absorb most/most of the mechanical stresses, in particular in correspondence with the connection area of the tubular duct 4 with the suction means 90, thus reducing or avoiding the stresses to the central portion 6 of the tubular duct 4, a portion which is inserted inside and passes through the endoscope 10. More in detail, in some preferred and possible embodiments, such as those shown in Figures 6 and 7, the proximal portion 14 it is made of a technopolymer, preferably polyamide based, for example it is in Grilamid nylon. More in detail, in some preferred and possible embodiments, such as those shown in Figures 6 and 7, the tubular body that defines the central 6 and distal 12 portion is made of an elastomeric thermoplastic material, preferably a block copolymer obtained from polycondensation of a carboxylic acid with a polyamide (PA) and of a polyether (PE) comprising a terminal alcohol group, for example it is in PEBAX®. Conveniently, the tubular body that defines the central 6 and distal 12 portion can be made of other thin and biocompatible plastic material, for example polytetrafluoroethylene (PTFE), high flexibility medical grade thermoplastic polymers, polyurethane (PU), in polyethylene (PE) and/or other materials commonly used for making tubes and catheters in the medical field.

Advantageously, at the distal end of the tubular duct 4 (ie at the end of the distal portion 12) a shielding element 51 is provided to protect the distal portion 12 of the tubular duct 4 from the laser means inserted inside the endoscope 10, in particular to prevent the latter from overheating or damaging the distal portion 12 made of polymeric material. Conveniently, the shielding element 51 comprises a tubular metal section 52, which for example is made of a metal alloy, such as stainless steel, for example AISI 304, or of titanium or titanium alloy or other suitable biocompatible metals or metal alloys and fit for purpose. Conveniently, the tubular metal section 52 consists of a small tube with continuous side walls (ie without holes or mesh parts). Conveniently, the tubular metal section 52 of the shielding element 51 is inserted inside the distal portion 12 of the tubular duct 4 (in particular in the case where the laser internally passes through the tubular duct 4) or it can be associated externally to the distal portion 12 so as to wrap it externally (in particular in the case in which the laser passes through the endoscope externally with respect to the tubular duct 4). Advantageously, the tubular metal section 52 can be joined to the tubular duct 4 by gluing or other production technologies known to the person skilled in the art.

Advantageously, in a possible embodiment, the distal portion 12 of the tubular duct 4 and the tubular metal section 52 are co-molded.

Preferably, the body/piece that defines the distal 12 and central 6 portion of the tubular duct 4 can have a greater longitudinal flexibility than the proximal portion 14 of the tubular duct itself. The tubular duct 4 has an internal and external diameter which are substantially constant along its entire longitudinal extension.

Advantageously, the distal portion 12 of the tubular duct 4, i.e. the portion intended to come out, at least in part, from the endoscope 10 to reach the target, consisting for example of a fragment of stone to be taken and held in order to mobilize it or remove it, it may comprise a frusto-conical termination which widens outwards so as to define at the distal end a greater surface useful for coupling with the target.

Advantageously, as mentioned, in a possible embodiment, the instruments used in the endourological treatment can be inserted inside the suction duct so that their corresponding end protrudes from the distal end of the tubular duct 4 which internally delimits said aspiration duct.

Advantageously, in a possible embodiment, the internal diameter of the distal portion 12 can be narrowed, preferably by about 10%, with respect to the remaining part of the central portion 6. This makes it possible to prevent entry into the tubular duct 4 of stones, or of their fragments or of other biological or fluid components, having a size comparable to that of the internal diameter of said tubular duct 4.

Advantageously, the tubular duct 4 has characteristics of transversal non- deformability substantially equal and constant along its entire longitudinal development.

Advantageously, the central 6 and distal 12 portion of the tubular duct 4 have characteristics of transversal non-deformability substantially equal and constant along their entire longitudinal development and, suitably, these characteristics can be different from those of the proximal portion 14 of the duct itself.

The dimensions of device 2 depend on the type of endoscope used. Preferably, the tubular duct 4 can have an external diameter, which is constant along its entire longitudinal extension, of about 0.8 - 1.2 mm, even more preferably of about 1.1 mm. Preferably, the tubular duct 4 can have an internal diameter, which is constant along its entire longitudinal extension, which is about 0.5-0.9 mm, even more preferably about 0.88 mm.

The connection unit 40 comprises a structure 41 which is internally hollow and which, suitably, is made of rigid material, preferably made of rigid polymeric material, such as ABS for example. The structure 41 can be made in a single piece, preferably by molding, or it can be made in several pieces intended to be joined together.

As said, the proximal portion 14 of the tubular duct 4 is inserted inside and passes through the structure 41 of the connection unit 40 so as to be able to slide inside the structure itself. In particular, the proximal portion 40 of the tubular duct 4 is slidably inserted inside the connection unit 40. Conveniently, the sliding of the proximal portion 14 of the tubular duct inside the connection unit 40 also causes the sliding of the central portion 6 of the tubular duct 4 inside the endoscope 10, thus also correspondingly varying the length of the distal portion 12 which enters and exits the tip of the endoscope 10.

Conveniently, as said, the device 2 also comprises said first connector 43 - hereinafter also referred to as "first connector" - for the mechanical and fluidic connection with suction means 93 external to the device 2. Preferably, said first connector 43 is an attachment connector for the suction means 93.

Conveniently, the connection unit 40 comprises a second connector 42 for attachment to the endoscope 10. Preferably, the second connector 42 is configured to lock the connection unit 40 to the endoscope 10. Conveniently, in use, the connection unit 40 is made integral with the endoscope 10 by means of the second connector 42 which, preferably, engages within a corresponding attachment seat provided/obtained in the endoscope 10.

Preferably, the second connector 42 is configured to define a sealed connection to the endoscope 10, to thus avoid the escape of fluids in correspondence with the connection of the connection unit 40 to the endoscope.

Preferably, the second connector 42 is configured to define a sealed connection of the connection unit 40 to the endoscope 10.

Conveniently, the second connector 42 is mounted on the structure 41 of the connection unit 40, it is internally crossed in a sliding manner by the tubular duct 4 and is configured to be removably constrained to an attachment seat provided/formed in the endoscope 10, to thus make the connection unit 40 integral with the endoscope itself. Conveniently, the attachment seat provided/obtained in the endoscope 10 is in communication with the operating channel 8 of the endoscope itself into which the tubular duct 4 is intended to be inserted, so that - by associating the second connector 42 of the connection unit 40 to said attachment seat of the endoscope 10 - the tubular duct 4 which emerges from the second connector 42 thus enters the corresponding operating channel 8 of the endoscope.

Preferably, in a preferred embodiment (see fig. 1-5), the connection unit 40 comprises a first connector 43. In particular, the first connector 43 for attachment to the suction means 93 is mounted on the connection unit 40 fitting and, in particular, on the structure 41 of said unit, which is made of polymeric material more rigid than the tubular duct 4. This is particularly advantageous since it allows to avoid direct contact between the suction means (and in particular of the suction circuit pipes connected to the vacuum source) and the tubular duct 4, thus avoiding or in any case decreasing the mechanical stresses suffered by the latter. Conveniently, according to the invention, the proximal portion 14 of the tubular duct 4 is not in direct mechanical connection with the suction means 93, but is fluidically connected with the suction means 93 by means of at least one element - such as for example the connection unit 40 in the embodiment of Figures 1- 5 - which is made of polymeric material more rigid than the tubular duct 4 and into which the proximal portion 14 of said duct is inserted.

Preferably, the second connector 42 for attachment to the endoscope 10 can be a connector of the "luer-lock" or "luer-slip" type, preferably female. Preferably, the second connector 42 can be coupled by interlocking or screwed to/in a corresponding attachment seat provided/obtained in the endoscope 10 so that the interior of the structure 41 of the connector unit is thus in communication with the operating channel 8 of the endoscope into which the tubular duct 4 is intended to be inserted.

Preferably, the first connector 43 for attachment to the suction means 93 can be a "luer-lock" or "luer-slip" type connector, preferably male, or it can be a conical connector, for example an elastic sheath or an elastic cap.

Advantageously, the second connector 42 can be arranged at an angle, preferably perpendicularly, with respect to the first connector 43.

The same device 2 also comprises means 55 for varying the length of the distal portion 12 of the tubular duct 4 which protrudes from the distal tip 21 of the endoscope 10, said means 55 comprise a gripping and control member 50 which is movable with respect to an element fixed or integral with the endoscope, preferably defined by said connection unit 40. Preferably, for example, the gripping and control member 50 can be defined by an annular shaped member configured to be crossed, and therefore moved, by the operator's finger. Preferably, the means 55 for varying the length of the distal portion 12 of the tubular duct 4 which protrudes from the tip of the endoscope 10 are of the telescopic type and, in particular, comprise a gripping and control member 50 which is slidably engaged within the connection unit 40, in particular within the structure 41 of said unit.

In particular, the same device 2 also comprises the gripping and control member 50 which is intended to be positioned outside the endoscope, to be thus operated by an operator, and which is operatively associated with the tubular duct 4 so that the action of an operator on the gripping and control member 50, which is intended to be positioned and to always be - at least partially - outside the endoscope, causes the movement/sliding of the tubular duct 4 inside the operating channel 8 of the endoscope 10 - in which the duct itself is inserted - to thus vary the length of the distal portion 12 of the tubular duct 4 which protrudes from the distal tip 21 of the endoscope 10. Conveniently, for example, by acting on the gripping and control member 50 it is possible to vary the length of the distal portion 12 of the tubular duct 4 which protrudes from the tip of the endoscope 10 from a few millimeters up to a centimeter or a couple of centimeters.

Conveniently, the gripping and control member 50 is positioned in correspondence with the connection unit 40 and, preferably, is mounted on the structure 41 of the connection unit 40.

Preferably, the structure 41 of the connection unit can be made entirely or, at least in part, in plastic material which is substantially transparent, in order to be able to see internally the movement of the gripping and control member 50. Conveniently, the gripping and control member 50 is internally hollow and/or comprises a passage cavity able to be crossed by the guide 72 for inserting the tubular duct 4 into the endoscope 10, as will be described in greater detail below.

Conveniently, in a possible embodiment shown in the figures, the gripping and control member 50 can comprise a piston portion 51, which slides within a corresponding cylindrical portion of the structure 41 of the connection unit 40, and a portion of grip 52. Conveniently, the grip portion 52 of the member 50 can have various shapes and/or arrangements in order to be comfortably and easily actuated manually by the operator.

Conveniently, the connection unit 40 - and in particular the structure 41 - is sealed and the gripping and control member 50 is mounted in a sealed manner and can slide with respect to the connection unit 40. In particular, the member the gripping and control member 50 is mounted hermetically on the structure 41 of the connection unit 40 and, at the same time, in such a way that the gripping member can be moved, in particular it is sliding, with respect to the structure 41. More in detail, the structure 41 comprises a through hole 45 into which the piston portion 52 of the member 50 is slidably inserted and, at the same time, said through hole 45 is traversed by said piston portion 52, also making a sealing of said hole.

Preferably, in a possible embodiment shown in the figures, the gripping and control member 50 can be movable in translation with respect to the connection unit 40, and in particular with respect to the structure 41 of said unit. Preferably, the gripping and control member 50 is a piston which slides within a cylindrical portion of the structure 41 of the connection unit 40. Conveniently, the direction of movement in translation M of the gripping and control member 50 can be parallel or also angled (see fig. 2) with respect to the translation/sliding direction X of the tubular duct 4 inside the endoscope 10 channel.

Advantageously, in a possible embodiment not shown here, the second connector 42 and/or the structure 41 can be configured (in particular shaped) so that the translation direction M of the gripping and control member 50 is parallel to the direction of sliding X of the tubular duct 4 inside the endoscope 10.

Conveniently, in a possible embodiment not shown in the figures, the gripping and control member 50 is movable in rotation with respect to the connection unit 40, in particular with respect to the structure 41 of said unit; in this case, for example, the gripping and control member 50 is operatively associated with the end or the proximal portion 14 of the tubular duct 4 and can be provided with a thread which engages with a corresponding counter-thread provided in the structure 41 of the connection unit 40 so that, by screwing/unscrewing the gripping and control member 50 with respect to the connection unit 40, the tubular duct 4 slides inside the endoscope, thus varying the length of the distal portion 12 which protrudes from the distal tip 21 of the endoscope 10.

Conveniently, as mentioned, the gripping and control member 50 is operatively associated with the proximal end or the proximal portion 14 of the tubular duct 4. In particular, the gripping and control member 50 is integral in movement (translation and/or rotation) with the proximal end or the proximal portion 14 of the tubular duct 4.

Advantageously, the gripping and control member 50 - preferably in correspondence of its internal end (ie the end which is housed within the structure 41) - is mechanically and operationally associated with the proximal end of the tubular duct 4 by means of a connection element 44. Preferably, the connection element 44 can comprise at least a first opening 46 in fluidic connection with the internal lumen of the tubular duct 4 and can also comprise at least a second opening 47 - preferably a plurality of second openings 47 - in fluidic connection with the suction means 93. More in detail, preferably, said at least one second opening 47 is in fluidic connection with the interior of the structure 41 and, therefore, through the first connector 43, with the suction means 93. Preferably, in a possible embodiment (cf. fig. 5), the connection element 44 comprises a first central opening 46 in fluidic connection with the internal lumen of the tubular duct 4 and a plurality of second openings 47 which are arranged around the first opening 46.

Advantageously, in a possible embodiment, the gripping and control member 50 is hollow internally and comprises a passage opening 53 which is configured to be in fluid communication with the external environment and also with the suction means 93. More in detail, preferably, the passage opening 53 is also fluidly connected, by means of the connection element 44, with the interior of the structure 41, and therefore both with the suction means 93 (through the first connector 43) and with the internal lumen of the tubular duct 4, the passage opening 53 is defined in correspondence with the gripping portion 52 of the member 50, to be thus easily closed and opened by the operator by moving the finger of the hand, preferably with the same hand with which you hold the endoscope.

Advantageously, in this way, it is possible to control the suction flow through the tubular duct 4, and in particular the suction force at the distal end - and therefore at the outlet - from the tubular duct 4, while maintaining the suction means 93 always activated; in fact, when the passage opening 53 is closed (for example directly and manually by the operator and/or by means of a cap controlled by a suitable button or lever) the suction means 93 are fluidically connected through the connection unit 40 directly and only with the lumen of the tubular duct 4, which can thus take and hold the target body with its distal portion 12 (such as for example a stone), while when the passage opening 53 is open to the external environment, then the suction means 93 are fluidically connected mainly with the external environment and, therefore, the suction force at the distal portion 12 of the tubular duct 4 is minimal or in any case it is not suitable for gripping and holding the target body to be moved. Advantageously, the connection element 44 can be configured in such a way as to also act as a limit switch for the movement of translation in extraction of the gripping and control member 50, and in particular it abuts with the edges around the through hole 45 of the structure 41. More in detail, for this purpose, the connecting element 44 has a larger diameter than that of the through hole 45 and of the piston portion 52 of the member 50. Conveniently, in another possible embodiment (not shown here), the limit switch block for moving the member 50 in translation can be mounted in another position, for example on the tubular duct 4, or it can have a different configuration.

Conveniently, in other possible embodiments (see fig. 6 and 7), the suction means 93 are connected to the gripping and control member 50. In particular, in a possible embodiment (see fig. 6 and 7), the end or proximal portion 14 of the tubular duct 4 is fixed to a first tubular section 61 which slides with respect to a second tubular section 62 (which thus defines said connection unit 40) which is provided with said second connector 42 for attachment to the endoscope 10.

Conveniently, a further unit 63 can be provided - which is distinct from the connection unit 40 defined by the second tubular section 62 - which is operatively associated/fixed to the first tubular section 61. Preferably, said further unit 63 comprises a further internally hollow structure 64, to thus allow a fluidic connection between the suction means 93 and the tubular duct 4.

Conveniently, in this embodiment, the gripping and control member 50 is defined by the assembly formed by the first tubular section 61 and by said further unit 63.

Preferably, said further structure 64 of said further unit 63 is made of a more rigid polymeric material than that with which the tubular duct 4 is made, for example it is made of ABS. Preferably, in a possible embodiment not shown here, the first tubular section 61 is made in a single body with said further structure 64 of said further unit 63.

Conveniently, said first connector 43 for connection with the suction means 93 (see fig. 6 and 7). Preferably, a further connector 47 can also be mounted on said further unit 63 for connection to the laser means (see Fig. 6).

Conveniently, in more detail, in a possible embodiment (see Fig. 6), said further unit 63 comprises a further structure 64 in which a main section 65 is provided on which said first connector 43 for attachment to the connecting means is mounted suction and a bifurcated section 66 on which said further connector 47 is mounted and which defines an access intended for the introduction of a fiber of the laser means into the lumen of said further structure 64 and from this then enters the tubular duct 4 (cf. fig. 6).

Conveniently, in a possible embodiment (see Fig. 7), said further unit 63 comprises a further structure 64 in which only a main section 65 is provided on which said first connector 43 for attachment to the suction means 93 is mounted, given that the fiber of the laser means is inserted and passes through a channel of the endoscope which is dedicated and distinct from that in which the tubular duct 4 is inserted.

Advantageously, also in these embodiments (see fig. 6 and 7), the suction means 93 are not mechanically connected to the tubular duct 4, but are fluidically connected to the latter by means of the further unit 63 which is the element mechanically connected directly to the suction means and which is made of a more rigid polymeric material than to the duct itself.

Conveniently, the sliding of the member 50 - which is defined by the assembly comprising the first tubular section 61 and said further connection unit 63 - with respect to the second tubular section 62 which is fixed to the endoscope 10, thus causes the length of the distal portion 14 of the tubular duct 4 which protrudes from the distal tip 21 of the endoscope 10.

Conveniently, therefore, the first connector 43 for attachment to the suction means 93 can be provided/mounted on the gripping and control member 50 which is movable with respect to the endoscope 10 (see Figs. 6 and 7) or it can be provided/mounted on the connection unit 40 which is fixed and integral with the endoscope 10 (see Figs. 1 and 2).

Preferably, the device 2 according to the invention also comprises an internal guide 72 which can be removably inserted into the tubular duct 4 in order to insert the latter into a operating channel 8 of the endoscope 10. In particular, the guide 72 comprises a rod 73 which can be removably inserted inside the tubular duct 4. Preferably, the diameter of the rod of the internal guide 72 is smaller than that of the internal lumen of the tubular duct 4 so that the latter obtains greater rigidity.

The internal guide 72 is configured to push the tubular duct 4 into the operating channel 8 of the endoscope 10. Preferably, the internal guide 72 and the tubular duct 4 are configured so that the internal guide 72 occupies a portion of the lumen of the tubular duct 4, thus giving it greater longitudinal rigidity and still maintaining a certain flexibility. In particular, the tubular duct 4 is flexible longitudinally and is substantially incompressible radially and, therefore, the internal guide 72 gives it greater longitudinal rigidity, thus allowing to facilitate its introduction into the operating channel 8 of the endoscope 10. Preferably, the internal guide 72 is made of metallic material, for example steel or titanium or titanium alloys.

Preferably, the internal guide 72 also comprises a handle 74 which has a larger diameter than the remaining part of the guide itself which is intended to pass through the tubular duct 4. Advantageously, the internal guide 72 is configured to pass through the connection unit 40 in sequence and then the tubular duct 4.

Advantageously, the internal guide 72 is configured to also pass through the gripping and control member 50; preferably, for this purpose, the gripping and control member 50 is provided with an additional passage opening 57 for the introduction of the internal guide 72 and, moreover, also the passage opening 53 is configured to be crossed by the internal guide 72.

Advantageously, the internal guide 72 can be inserted inside the gripping and control member 50 by first passing through an additional passage opening 57 and then the passage opening 53, in order to cross the structure 41 of the connection unit 40 and from here enter and cross the tubular duct 4 until reaching the distal portion 12 of the latter.

The device 2 according to the invention can be used with any endoscope 10 which is provided with one or more channels.

Preferably, the endoscope 10 is equipped, at its distal tip 21, with an illumination source 81, which can preferably comprise optic fiber light beams or LED diodes, and with a video sensor 82, preferably a camera or a CCD type detector. Conveniently, the illumination source 81 and the video sensor 82 are connected by means of power supply and/or signal transmission cables (not shown), which pass through the endoscope, with a power source and/or a processing unit, which can be external to the endoscope or integrated into the endoscope. Advantageously, the endoscope 10 can comprise a first operating channel 8, inside which the device 2 is inserted, and also a further/second operating channel 83, for example for laser means and, in particular, for fibers connected to a laser source. Advantageously, the device 2 can be inserted inside any longitudinal operating channel 8, operative or even non-operative, of an endoscope 10.

For example, the endoscope 10 can be a flexible ureteronephroscope for kidney stones, a rigid cystoscope or flexible for bladder stones, a rigid ureteroscope for ureteral stones and a rigid or flexible nephroscope for kidney or ureteral stones.

The operation of the device 2 according to the invention clearly follows from what has been previously described.

Initially, the internal guide 72 is inserted inside the tubular duct 4 by first passing through a part of the connection unit 40 and, preferably, also passing through the gripping and control member 50. Therefore, the device 2, thus configured, can be easily inserted through the operating channel 8 of the endoscope 10 and allow the distal portion 12 to emerge from the end of the endoscope inserted inside the patient's body.

The internal guide 72 of the device 2 substantially serves to facilitate the introduction of the device itself into the endoscope 10. In fact, advantageously, the internal guide 72 always keeps the device 2 in extension and thus prevents it from swelling due to the effect of compression thrust necessary for its insertion into the operative operating channel 8.

Once the device 2 has been completely introduced into the endoscope 10, the internal guide 72 of the device 2 is extracted from the tubular duct 4 and from the connection unit 40.

Before or after this insertion step, the first connector 43 of the connection unit can be connected to the suction means 93.

At this point, the surgeon/operator can maneuver the endoscope 10 until reaching the calculation and, a once reached, the suction flow is activated through the tubular duct 4 to attract and then hold the stone, or other target target to be moved during the stretch endoscopic chin, at the end of the distal portion 12 of the tubular duct 4. Furthermore, if it is necessary to release and remove the fragment from the distal end 6 of the device 2, it is sufficient to deactivate the suction flow through the tubular duct 4, and this for example it can be done by acting in correspondence with the opening 53 for the fluidic connection of the suction means 93 and the tubular duct 4 towards the external environment.

Therefore, again through aspiration, the stone (or other target body) thus retained can be mobilized according to need or possibly to be extracted from the urinary excretory path. More in detail, once the stone has been captured at the distal end of the tubular duct 4, the surgical operator can extract the endoscope 10 from the patient's body and at the same time extract the stone retained by the device 2 inserted in the operating channel 8 of the endoscope itself.

Advantageously, during use, the surgical operator can, if necessary, vary the length of the distal portion 12 of the tubular duct 4 of the device 2 which protrudes from the distal tip 21 of the endoscope 10 simply by acting on the gripping and control member 50, for example by making it slide towards M1 (see fig. 4a) or away from M2 (see fig. 4b) with respect to the connection unit 40 which is fixed to the endoscope 10, thus causing respectively a greater or lesser exit of the portion 12 of the tubular duct from the distal tip 21 of the endoscope 10. Conveniently, in the condition of fig. 4b, i.e. of maximum extraction/removal of the gripping and control member 50 from the connection unit 40, the distal portion 12 can be completely inserted inside the endoscope or it can protrude by a minimum length from the distal tip 21 of the endoscope 10.

Conveniently, in the condition of fig. 4b, i.e. of maximum insertion/approach of the gripping and control member 50 in the connection unit 40, the distal portion 12 protrudes by a maximum length from the distal tip 21 of the endoscope 10.

As mentioned, in the case of clinical indication, it is also possible to introduce in the endoscope - inside the same tubular duct 4 of the device 2 or, inside the same channel in which the device 2 is inserted but externally with respect to the tubular duct 4, or again inside a different channel with respect to that in which the device 2 is inserted - laser means comprising a fiber connected to a laser source.

Advantageously, the use of a laser fiber, inserted inside the tubular duct 4 or outside the latter, allows to carry out the laser trissy of the stone, while at the same time the lithiasic dust thus produced is aspirated, by the suction means 93, inside the suction duct defined by the tubular duct 4. Conveniently, the laser fiber can also be used for treatments other than stones, for example, it can in fact be used, at modulated frequency and energy, for the ablation of neoformations of the via excretory or to incise a soft tissue to be collected and analyzed (for example for a biopsy). Advantageously, in a possible use of the device 2, the tubular duct 4 which is in fluidic connection with the suction means 93 defines a suction duct to thus retain a soft tissue to be removed for analysis (biopsy). In particular, the soft tissue is withdrawn and retained by means of the distal end of the tubular duct 4 which protrudes from the distal tip 21 of the endoscope, while the incision is made with the laser fiber to thus separate the soft tissue to be removed from the surrounding tissue. Advantageously, gripping tools, such as baskets, can be introduced inside other channels of the endoscope to capture and retain the stone or any foreign body, so as to facilitate its extraction from the urinary excretory path. Furthermore, as needed, dedicated pliers can be introduced into another channel of the endoscope 10 to perform biopsies. Advantageously, inside a channel of the endoscope, a catheter for injection of substances can be introduced in order to perform a topical treatment, for example chemotherapy, hemostatic, contrast, drainage or other.

Conveniently, in the case, not shown here, in which the endoscope 10 has a double operating channel, the irrigation of the treated site takes place through a second dedicated operating channel 83, which is different from the operating channel 8, in which the device 2 is inserted. On the other hand, in the case of an endoscope 10 provided with a single operating channel 8, irrigation takes place through the annular space defined between the external wall of the tubular duct 4 and the internal wall of the operating channel 8.

However, in the event that a fragment gets stuck, it is possible to detach the suction means from the first connector 43, in order to insert a guide or other suitable means for removing the fragment.

The present invention also relates to an endoscope 10 - as described above - in which, inside a channel, a device as described above is inserted or incorporated/integrated. The distal portion 12 of the tubular duct 4 of the device 2 protrudes from the distal tip 21 of the endoscope 10 in an adjustable way in length by acting on the gripping and control member 50 of the device itself which is operatively associated with the proximal end or portion of the tubular duct 4. In particular, the length of the part of the distal portion 12 of the duct 4 which protrudes from the distal end of the endoscope is adjustable and, preferably, can be varied by acting on the gripping and control member 50 which is movable with respect to a connection unit 40 which is fixed or integrated in the endoscope 10.

It follows from what has been said that the minimally invasive device 2, according to the invention, for endoscopic treatment, preferably endourological, is particularly advantageous in that:

- allows you to adjust, during use, the length of the distal portion that protrudes from the end of the endoscope,

- since there is no direct mechanical connection between the suction means and the tubular duct, the stresses on said duct are avoided or in any case reduced,

- it can be used, without any risk of damage, in combination with a fiber connected to a laser source,

- has characteristics that do not hinder the flexibility of the endoscopic instrument, - it is able to reach the most peripheral districts of the urinary tract;

- it uses suction as a traction force, and in this way it allows to attract fragments of the most varied dimensions, even the smallest and most secluded ones that are difficult to clean up with traditional devices; - it allows to carry out an easy and immediate aspiration, even for secluded calculations, thus avoiding the particularly laborious maneuvers required by traditional devices to clean up the site from the calculations or its fragments;

- is able to attract the stone or its fragments to be mobilized or removed at its distal end;

- it can be used with a plurality of instruments used in endourological treatment, and in particular with a laser source for lithotripsy, with a grasping instrument and/or with a catheter for injecting substances,

- it allows to interrupt the holding of the stone or its fragments at any time simply by interrupting the flow of aspiration through the tubular duct;

- drastically reduces the need to replace the device in use with another device during the same endourological procedure,

- thanks to its constructive simplicity it allows a saving of production costs.

The minimally invasive device according to the invention has been described and is particularly suitable for the treatment of stones through laser lithotripsy; however, it can be used for other urological endoscopic treatments, such as the reclamation of ureteral, bladder or intrarenal stones, carried out using the various types of endoscopes currently available or, more extensively, it can be used for the aspiration of laser treatment results, also on fabrics, carried out through the laser fiber which can be introduced inside the suction duct provided in the device or on another channel of the endoscope.

The present invention has been illustrated and described in some of its preferred embodiments, but it is understood that executive variations may apply thereto in practice, without however departing from the scope of protection of the present patent for industrial invention.

Claims

C L A I M S

1. Invasive device (2) for endoscopic treatment, preferably for endourological treatment, comprising a tubular duct (4), flexible longitudinally, intended to be inserted and crossed the channel (8) of an endoscope (10), said tubular duct (4) internally delimits an intake duct and includes:

- a central portion (6) intended to pass through the operating channel (8) of the endoscope (10),

- a portion (12) which in operation is the distal one and which is intended to come out, at least in part, from the distal tip (21) of the endoscope (10), inserted in the patient's body, and this in order to reach the target to be taken and/or withheld,

- a proximal portion (14) which is opposite to said distal portion (12), and characterized in that it comprises:

- a connection unit (40) which is configured to be fixed to an endoscope (10) or to be integrated in an endoscope (10) and which is traversed, at least in part, by said proximal portion (14),

- means (55) which are operatively associated with the end and/or proximal portion (14) of said tubular duct (4) and which are movable with respect to the connection unit (40) to vary the length of the distal portion (12) of the tubular duct (4) protruding from the distal tip (21) of the endoscope (10), - a first connector (43) for the mechanical and fluidic connection to suction means (93).

2. Device according to claim 1, characterized in that it is configured so that said proximal portion (14) of the tubular duct (4) is in fluidic connection with suction means (93) intended to be attached to said first connector (43), without there being a direct mechanical connection between said proximal portion (14) and said suction means (93).

3. Device according to one or more of the preceding claims, characterized in that the end and/or proximal portion (14) of the tubular duct (4) is spaced apart, or in any case not in contact, from said first connector (43) for the connection to the suction means (93).

4. Device according to one or more of the preceding claims, characterized in that said connection unit (40) comprises a second connector (42) for attachment to the endoscope (10).

5. Device according to one or more of the preceding claims, characterized in that said second connector (42) is configured to lock the connection unit (40) to the endoscope (10).

6. Device according to one or more of the preceding claims, characterized in that said first connector (43) and/or said second connector (42) is of the luer-lock or luer-slip type.

7. Device according to one or more of the preceding claims, characterized in that said first connector (43) and/or said second connector (42) is of the conical type, preferably comprises an elastic sheath or elastic cap.

8. Device according to one or more of the preceding claims, characterized in that the distal portion (12) which is intended to protrude from the distal tip (21) of the endoscope is made in a single piece with the central portion (6).

9. Device according to one or more of the preceding claims, characterized in that the distal portion (12), which is intended to protrude from the distal tip (21), and the central portion (6) are made of the same polymeric material.

10. Device according to one or more of the preceding claims, characterized in that said tubular duct is configured in such a way as to act exclusively and only as a suction duct.

11. Device according to one or more of the preceding claims, characterized in that the central portion (6), the distal portion (12) and the proximal portion (14) are made in a single body/piece of the same polymeric material.

12. Device according to one or more of the preceding claims, characterized in that the proximal portion (14) of the tubular duct (4) is made of a different and more rigid polymeric material than that of the central (6) and/or distal portion (12).

13. Device according to one or more of the preceding claims, characterized in that, at the distal end of the tubular duct (4), a shielding element (51) is provided, preferably defined by a tubular metal section (52), to thus protect the distal portion (12) of the tubular duct (4) from laser means.

14. Device according to one or more of the preceding claims, characterized in that said means (55) comprise a gripping and control member (50) which is operatively associated with the end and/or proximal portion (14) of said tubular duct (4) and which is movable in translation and/or rotation with respect to said connection unit (40).

15. Device according to one or more of the preceding claims, characterized in that said first connector (43) for the mechanical and fluidic connection to suction means (93) is mounted or obtained on said connection unit (40).

16. Device according to one or more of the preceding claims, characterized in that said first connector (43) for the mechanical and fluidic connection to suction means (93) is mounted or obtained on said gripping and control member (50).

17. Device according to one or more of the preceding claims, characterized in that the connection unit (40) is sealed closed.

18. Device according to one or more of the preceding claims, characterized in that said means (55) comprise a gripping and control member (50) which is mounted hermetically and can slide relative to the connection unit (40).

19. Device according to one or more of the preceding claims, characterized in that said connection unit (40) comprises a structure (41) which is internally at least partially hollow and which is made of rigid polymeric material, preferably of a more rigid polymeric material with respect to that/those of said tubular duct (4).

20. Device according to one or more of the preceding claims, characterized in that the gripping and control member (50) is mechanically and operationally associated with the proximal end of the tubular duct (4) by means of a connection element (44) which is provided with at least a first opening (46) in fluidic connection with the tubular duct (4) and at least one second opening (47) in fluidic connection with the suction means (93).

21. Device according to one or more of the preceding claims, characterized in that said connection unit (40) comprises a structure (41) which is internally at least partially hollow and said at least one second opening (47) is in fluidic connection with the interior of said structure (41), thus resulting in fluid communication with the suction means (93) through said first connector (43).

22. Device according to one or more of the preceding claims, characterized in that the gripping and control member (50) comprises a passage opening (53) configured to be in fluid communication with the external environment and also with the suction means (93).

23. Device according to the preceding claim, characterized in that said passage opening (53) of the gripping and control member (50) is connected by means of said connection element (44) with the interior of the structure (41 ) of the fitting unit.

24. Device according to one or more of the preceding claims, characterized in that the connection element (44) is configured in such a way as to act as a limit switch for the extraction movement of the gripping and control member (50).

25. Device according to one or more of the preceding claims, characterized in that it also comprises an internal guide (72) configured to be inserted in a removable way inside the tubular duct (4) in order to insert said tubular duct (4) to the inside the operating channel (8) of the endoscope (10).

26. Device according to the preceding claim, characterized in that the internal guide (72) is configured to pass through the connection unit (40) and the tubular duct (4) in sequence.

27. Device according to the preceding claim, characterized in that the internal guide (72) is configured to also pass through the gripping and control member (50).

28. Endoscope (10) to be used for an endoscopic treatment, preferably for an endourological treatment, comprising at least one operating channel (8) and characterized in that: - inside said at least one operating channel (8) the tubular duct (4) of a minimally invasive device (2) according to one or more of the preceding claims is inserted or integrated so that the distal portion (12) of said tubular duct (4) protrudes from the distal tip (21) of the endoscope itself by a length which is variable through said means (55) with which said device is provided,

- the connection unit (40) of said device (2) is fixed directly or indirectly to said endoscope (10), preferably in a removable way, or it is integrated in said endoscope (10).