WO2023007369A1

WO2023007369A1 - An improved introducer device.

Info

Publication number: WO2023007369A1
Application number: PCT/IB2022/056884
Authority: WO
Inventors: Filippo NIGRO; Maurizio CASAROTTO
Original assignee: Fmp Biotechnologies Srl
Current assignee: Fmp Biotechnologies Srl
Priority date: 2021-07-26
Filing date: 2022-07-26
Publication date: 2023-02-02
Anticipated expiration: 2024-01-26

Abstract

Introducer device (2), in particular ureteral, to be used for minimally invasive medical treatments, preferably for endourological treatments, characterized by the fact of comprising: - a tubular element (3) intended to be inserted inside the patient's body to bring its distal end (5) in correspondence with the intervention site, preferably inside the kidney, and by the fact that: - said tubular element (3) is configured to be crossed internally and longitudinally by an endoscope which is intended to be inserted inside said tubular element (3) so as to bring the distal tip of the endoscope in correspondence with the distal end of said tubular element (3), - at the distal end (5) of the tubular element (3) means (6) are provided which are configured to prevent the distal tip of the endoscope from escaping from said distal end (5) and this without hindering or impeding the functions of the endoscope itself, - said tubular element (3) has an internal diameter which is greater than the external diameter of the endoscope which is intended to be inserted and to cross longitudinally the tubular element, so as to have within the same tubular element (3) a space between the internal walls of the tubular element (3) and the external walls of the endoscope to thus define an irrigation channel and/or for the insertion of an irrigation pipe.

Description

AN IMPROVED INTRODUCER DEVICE.

The present invention relates to an introducing device, in particular ureteral, for minimally invasive medical treatments, preferably for endourological treatments.

Among the instruments used in the endourological field are known the ureteral access sheats (in English "Ureteral access sheats" or also called "UAS") which basically act as a ureteral introducer and serve to facilitate access to the kidney when multiple passages are required during the endourological procedure. In particular, ureteral access sheaths are commonly used to facilitate flexible ureteroscopy in the treatment of urolithiasis. With the ureteroscopes currently in use, the most used sheaths are represented by those whose size is substantially 10/12 Fr or 12/14 Fr.

Various studies have highlighted the practical role of ureteral access sheaths in reducing operating times, allowing passages multiple instruments and protect the ureteroscope. Additionally, ureteral access sheaths allow for improved visualization and reduced intrarenal pressure during ureteronephroscopy. The choice of ureteral access sheaths among models from various manufacturers generally depends on the skills, experience and preferences of the surgeon, as well as the cost and size of the ureteroscope. Furthermore, the physical characteristics of ureteral access sheaths vary by manufacturer and model, and these specific characteristics determine their clinical applicability. More specifically, the dilator tip shape, flexibility and ease of extraction can affect ureteral safety during sheath advancement and extraction. In addition, the strength of the sheath and the ability to withstand forces in various directions affect how the sheath is inserted.

There are already several ureteral access sheaths on the market, including Terumo's Glideway, Terumo's Pathway (which is a balloon expandable sheath) and Boston Scientific's Navigator HD.

Currently, the known ureteral access sheaths have physical and mechanical characteristics which are not optimal in terms of ergonomics, efficacy and safety for the patient.

Furthermore, the current ureteral access sheaths exclusively define a connection and access passage to the kidney, without allowing any further additional operational functionality.

Further, it should be considered that irrigation to allow access to the inside of the kidney is currently provided through an internal channel of the endoscope, thus resulting modest and ineffective. US 9,782,566 discloses a sheath comprising an internal duct which is crossed by a tube which defines a passage through which endoscopic procedures can be performed. The sheath has characteristics that prevent its excessive curvature and at the distal end a narrowing of the diameter of the internal duct in order to prevent the entry into the duct itself of excessively large stones that could lead to a clogging of the tube itself. However, this solution is not fully satisfactory as this type of sheath cannot follow the endoscope as it does not have any anchoring system of the endoscope in the distal part.

WO 2020/114180 discloses a device to be used during thrombectomy operations, in order to pass a device suitable for crushing the thrombus and a device suitable for sucking them.

US 2018/0078684 discloses a tube for sucking fluids during a surgical operation. The object of the invention is to propose an introducer device, in particular ureteral, for minimally invasive medical treatments, preferably endourological, which allows to overcome, at least in part, the drawbacks of the known solutions.

Another object of the invention is to propose an introducer device which is improved and optimized with respect to the known ureteral access sheaths Another object of the invention is to propose an introducer device which has additional operational functions with respect to that of defining a connecting tube/channel to enter the kidney.

Another object of the invention is to propose an introducer device which facilitates and improves irrigation for access to the inside of the kidney. Another object of the invention is to propose an introducer device which allows to bring/have the irrigation precisely in correspondence with the treatment site where the distal tip of the endoscope acts.

Another purpose of the invention is to propose an introducer device that allows irrigation exactly where it is needed, and this not only for fluidic compensation (i.e. in order to maintain the balance between extraction and supply of fluids inside the kidney). , but also for cleaning the site immediately in front of the distal part of the endoscope.

Another object of the invention is to propose an introducer device that can be used with endoscopes currently available on the market.

Another object of the invention is to propose an introducer device which is ergonomic, effective and safe for the patient.

Another object of the invention is to realize an introducer device which has a high accuracy, reliability and safety.

Another object of the invention is to provide an introducer device which is multifunctional and which reduces surgical times. Another object of the invention is to provide an introducer 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 an introducer device which can be obtained simply, quickly and with low costs.

Another object of the invention is to provide an introducer device with an improving and/or alternative characterization, in terms of construction, functionality and performance, with respect to traditional ones.

Another object of the invention is to provide a device that allows to measure the pressure and the endopyelic/intrarenal pressure.

Another object of the invention is to provide a device that allows both to measure and to control/optimize the endopyelic/intrarenal pressure.

All these purposes, considered individually or in any combination thereof, and others that will result from the following description, are achieved, according to the invention, with an introducer device with the characteristics indicated in claim 1.

The present invention is further clarified below in some of its preferred embodiments, reported for purely illustrative and non-limiting purposes with reference to the attached drawings, in which: figure 1 schematically shows a first embodiment of the introducer device according to the invention with the guiding element extracted with respect to the tubular element, figure 1a shows an enlarged detail of fig. 1, figure 2 shows a schematic view of the device of fig. 1 in which the guiding element is partially inserted inside the tubular element, figure 3 shows a schematic view of the device of Fig. 1 in which the guiding element is completely inserted inside the tubular element and the expandable element is in a retracted/contracted condition, figure 4 shows a schematic view of the device of Fig. 1 in which the guiding element is completely inserted inside the tubular element and the expandable element is in the expanded condition, figure 4a shows an enlarged detail of fig. 4, figure 5 shows in front schematic view a first embodiment of the distal end of the tubular element, figure 6 shows in front schematic view a different/second embodiment of the distal end of the tubular element, figure 7 shows in schematic view a second/different embodiment of the tubular element of the device, figure 8A shows section AA of fig. 7 in a first variant, figure 8B shows section AA of fig. 7 in a second variant, figure 9 schematically shows a third embodiment of the tubular element of the device.

As can be seen from the figures, the introducer device 2 according to the invention, in particular ureteral, to be used for minimally invasive medical treatments, preferably for endourological treatments, comprises a tubular element 3 intended to be inserted inside the patient's body to carry its distal end 5 at the site of intervention, preferably inside the kidney.

Advantageously, the introducer device 2 also comprises a guiding element 4 which is configured to be slidably inserted inside the tubular element 3 and also to be slidably extracted from the latter.

The tubular element 3 is configured to be crossed internally and longitudinally by an endoscope (not shown) which is intended to be inserted inside said tubular element 3 so as to bring the distal tip of the endoscope at the distal end of said tubular element 3.

Preferably, the tubular element 3 can be configured to be fluidically connected with irrigation means. Advantageously, therefore, the combination of the tubular element 3 and the endoscope allow irrigation to be brought exactly to the site where the endoscope itself is intended to carry out the endourological treatment.

Conveniently, the tubular element 3, with longitudinal development, is made of biocompatible polymeric material. Preferably, the tubular element 3 defines a sheath/jacket inside which both the guiding element 4 and the endoscope can slide in insertion/extraction.

Conveniently, the guiding element 4 acts as a mandrel (ie as a support) for the tubular element 3 during the phase of introduction into the patient's body, as described in greater detail below.

Conveniently, the tubular element 3 is made of a more flexible and less rigid material than the guiding element 4.

The tubular element 3 has an internal diameter which is greater than the external diameter of the endoscope, which is intended to be inserted and to cross longitudinally the tubular element itself, so as to leave/have within the same tubular element 3 a space between the internal walls of the tubular element 3 and the external walls of the endoscope, to thus define an irrigation channel/duct or for the insertion of an irrigation pipe. Preferably, said irrigation channel/duct which is defined inside the tubular element 3 between the internal walls of the tubular element itself and the external walls of the endoscope has a substantially annular section.

Conveniently, the tubular element 3 has an internal diameter which is greater, preferably by about 3-6Fr greater, than the external diameter of the endoscope which is intended to be inserted and to cross longitudinally the tubular element, to thus define a channel the irrigation duct inside the tubular element itself, in particular in the space defined between the internal walls of the tubular element 3 and the external walls of the endoscope. Preferably, the tubular element 3 can have a length substantially corresponding to that of the endoscope which is intended to pass through said tubular element.

The endoscope which can be inserted inside the tubular element 3 can be of the reusable type or also of the disposable type (ie single-patient).

Conveniently, at its distal end 5 - which is intended to be inserted into the patient's body during endoscopy - the tubular element 3 comprises means 6 to prevent the distal tip of the endoscope, which is intended to be inserted inside and passing through the tubular element 3, it protrudes from the tubular element 3 and this without hindering or impeding the operating functions (in particular lighting and/or vision) of the endoscope itself.

Advantageously, in this way, it is possible to bring irrigation exactly in correspondence with the treatment site defined by the area in front of the distal tip of the endoscope, where this area also corresponds to the area in front of the distal end 5 of the tubular element 3 since the distal tip of the endoscope is positioned (without the possibility of coming out) at the distal end 5 of the tubular element 3.

Conveniently, according to the invention, the tubular element 3 follows the endoscope to the internal treatment site, thus allowing irrigation to be brought (through a passage which is external to the endoscope but internal to the tubular element 3) exactly in correspondence with the treatment site.

Preferably, these means 6 for preventing the distal tip of the endoscope from escaping from the distal end 5 of the tubular element 3 may comprise elements for engaging the distal tip of the endoscope.

Advantageously, these means 6 for preventing the distal tip of the endoscope from escaping from the distal end 5 of the tubular element 3 can comprise a body, preferably ring-shaped 60, which is configured to block/prevent the advancement of the distal tip of the endoscope towards the outside of the distal end 5 of the tubular element 3 and this without hindering or impeding the operational functions of the endoscope itself. Preferably, said operational functions of the endoscope include irrigation and/or illumination by means of a light source mounted on the tip of the endoscope and/or vision by means of a vision sensor (for example a CCD or CMOS camera) mounted on the tip. endoscope. Conveniently, the ring 60 is associated/mounted by means of radial septa 61 on the tubular element 3. Preferably, the ring 60 is fixed by means of radial septa 61 to the walls of the tubular element 3 at the distal end 5 of the latter. Conveniently, the ring 60 and the radial septa 61 hold the distal tip of the endoscope without impeding or otherwise hindering the other functions of the endoscope, such as irrigation, illumination by means of a light source mounted on the tip of the endoscope vision by means of a vision sensor (for example a CCD or CMOS camera) mounted on the tip of the endoscope, or other operational functions, such as for example those obtainable with a laser fiber.

In a possible embodiment (see fig. 5), the retaining ring 60 for the distal tip of the endoscope can be centered with respect to the center of the circular section that the tubular element 3 has at its distal end 5 In another possible embodiment (see fig. 6), the retention ring 60 for the distal tip of the endoscope can be off-centered with respect to the center of the circular section that the tubular element 3 has at its distal end 5.

Conveniently, the ring 60 and/or the septa 61 are made in a single body and of the same material as the tubular element 3 and/or they can be made of a different material and, in this case, they can be co-molded or fixed between them by gluing or with other technologies known to the skilled person. Conveniently, the tubular element 3 is flexible longitudinally, preferably along its entire longitudinal development and/or at least in correspondence with its distal part.

In particular, the tubular element 3 comprises:

- a central portion 7 intended to pass through the patient's body, and in particular the patient's urethra and ureter, - a distal end 5 which is intended to come into contact or in the vicinity of the desired intervention site which, in particular, can be defined by the pyelo-ureteral joint/renal ampulla,

- a portion 14 - which in operation is the proximal one and which is defined at one end of the tubular element 3 which it is opposite to that in which it is defined at the distal end 5 which is destined to protrude, at least in part, from the patient's body.

Conveniently, the proximal portion 14 comprises a mouth 16, preferably of a frusto-conical shape, for the passage (alternatively) of the guiding element 4 and of the endoscope.

Conveniently, at least one organ 17 can be provided in correspondence with the proximal 14 and/or central 7 portion to hold the endoscope, once it has been inserted inside the tubular element. Preferably, said organ 17 comprises a sealing gasket for coupling with the endoscope which is intended to be inserted inside and to cross the tubular element 3, to thus prevent the proximal portion 14 of the tubular element 3, what said endoscope is inserted inside the tubular element itself, is in communication with the outside. Conveniently, in correspondence with the proximal portion 14, a (first) connector

15 for attachment can also be provided for irrigation means, in particular for the introduction of liquids inside the tubular element 3. Preferably, the connector 15 is mounted on a section that forks from the proximal portion 14 of the tubular element 3.

The tubular element 3 internally delimits a passage duct for the introduction of a traditional endoscope and/or any other instruments used in endoscopic treatment, for example endourological.

Preferably, in a possible embodiment, inside the tubular element 3 the irrigation channel/passage is defined in the interspace between the external walls of the endoscope and the internal walls of the tubular element 3. Preferably, in a possible embodiment, inside the tubular element 3 in the space defined between the external walls of the endoscope and the internal walls of the tubular element 3, a barrel can be removably inserted - which is external to the endoscope and distinct from the latter - for the introduction of irrigation liquids. Conveniently, the irrigation barrel, while being external to the endoscope, can be hooked to the latter in order to be moved by the endoscope in the insertion/extraction crossing inside the tubular element 3, thus carrying both the endoscope and the irrigation pipe near the intervention site.

Preferably, the tubular element 3 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 the contraction and extension forces.

Preferably, the tubular element 3 is made in a single body of an elastomeric and biocompatible thermoplastic material, for example in polytetrafluoroethylene (PTFE), in thermoplastic polymers with high flexibility medical grade, in polyurethane (PU), in polyethylene (PE) and/or in other materials commonly used for making ureteral access. For example, the tubular element 3 is a block copolymer obtained from the polycondensation of a carboxylic acid with a polyamide (PA) and a polyether (PE) comprising a terminal alcohol group, for example it is made of PEBAX®.

Preferably, in a possible embodiment, the tubular element 3 can be made of a radially yieldable/expandable material, preferably in an elastic way, until a predefined maximum diameter is reached. Conveniently, in this case, the tubular element 3 is configured to expand as a result of the pressure deriving from the passage of the irrigation fluid.

Conveniently, the guiding element 4 comprises a longitudinal body 40 which is configured to internally pass through the tubular element 3. Conveniently, the guiding element 4 is provided with a distal end 41 which is intended to protrude from the distal end 5 of said tubular element 3. Preferably, the distal end 5 is configured to go beyond the means 60 provided to prevent the distal tip of the endoscope from coming out. Conveniently, the guiding element 4 comprises, in correspondence with the region opposite to the distal end 41 , a proximal portion 42. Conveniently, the distal end 41 of the guiding element 4 comprises or is defined by an expandable element 50 which is configured to switch between a first expanded condition (inflated, see fig. 4) and a second retracted/contracted condition (deflated, see fig. 1, 2 and 3). In particular, when it is in said first expanded (inflated) condition, the expandable element 50 has a greater radial bulk, while when it is in said second retracted/contracted (deflated) condition, the expandable element 50 has a smaller radial bulk, preferably substantially equal to that of the diameter of the central part of the body 40 of the guiding element 4. Conveniently, in said first expanded condition, said expandable element 50 has a greater radial dimension with respect to the minimum passage opening defined by the means 6, while in said second retracted/contracted condition, said expandable element 50 has a smaller radial bulk with respect to the minimum passage opening defined by the means 6.

Advantageously, when the expandable element 50 is in said first expanded condition (see fig. 4 and 4A), assumes a substantially ogive shape covering the wall of the distal end 5 of the tubular element 3, to thus allow access atraumatic to within the urethra and ureter (as will be explained in more detail below).

Conveniently, the guiding element 4 comprises one or more channels which cross it along the whole or a large part of its longitudinal extension, and which in particular cross the body 40 going from the proximal portion 42 to the distal end 41.

In in particular, a first longitudinal channel 45 is provided which is fluidically connected with the interior of the expandable element 50 provided at the distal end 41 and is also fluidically connected with a further (second) connector 43 for the attachment of inflating means (e.g. e.g. a syringe, not shown) configured to cause the expandable element 50 to pass from said second retracted condition to said first expanded condition. In particular, said inflation means are configured to fill the expandable element 50 with a fluid (liquid or gas) so as to cause its expansion/expansion, thus increasing its volume, thus avoiding the extraction movement of the guiding element 4 from the tubular element 3 and also covering the distal end 5 of the latter so as to allow atraumatic access of the assembly formed by the tubular element 3 crossed internally by the guiding element 4.

Advantageously, the guiding element 4 comprises a second through channel 46 which is open outwards and which passes through the body 40 from side to side (i.e. from the distal end 5 to the end of the proximal portion 42). Preferably, said second channel 46 defines a passage channel for a guide wire (not shown).

Conveniently, in some possible embodiments (see Figs. 7 and 9), the tubular element 3 can comprise a drainage channel 30, to thus recover the excess liquid present near the distal end of the tubular element 3 Conveniently, the drainage channel 30 is fluidically separated from the remaining part 31 of the internal lumen of the tubular element 3.

Preferably, the drainage channel 30 is housed inside the tubular element 3. In a possible and alternative form of embodiment, the drainage channel 30 can be positioned outside the tubular element 3, while being fixed/integrated - or in any case integral in translation - with the tubular element.

Advantageously, the drainage channel 30 - which is preferably provided inside the tubular element 3 - allows the pressure inside the kidney to be kept balanced, in particular it allows the liquid that is introduced through irrigation to escape from the kidney.

Conveniently, the drainage channel 30 is fluidly in communication with a third connector 32 for the attachment of suction means (not shown). In particular, the third connector 32 is provided in correspondence with the proximal portion 14 of the tubular element 3, preferably it is mounted on a dedicated portion that starts from the proximal portion 14.

Conveniently, the drainage channel 30 defined inside the tubular element 3 is fluidly in communication with at least one opening 33 which is defined in proximity to the distal end 5 of the tubular element 3. Preferably, the opening 33 is defined on a side wall of the drainage channel 30 and is slightly spaced, for example about 1 cm, from the distal end 5 of the tubular element 3.

Preferably, in a possible embodiment (see Fig. 8A), the drainage channel 30 is defined between the internal walls of the tubular element 3 and a separation wall 34 which is fixed/integrated internally to the inner walls of the tubular element 3. Preferably, in a possible embodiment (see Fig. 8B), the drainage channel 30 is defined by a dedicated tube 35 which is housed inside the tubular element 3 and which is fixed/integral with the internal walls of said element. The tubular element 3 provided with an internal drainage channel 30 can be configured to have different stiffnesses - in terms of dimensions (in particular of thickness) and/or of the material used - along its longitudinal development. In particular, the central portion 7 - which is intended to pass through the ureter - can have a longitudinal flexiblity lower than the distal portion (ie the portion corresponding to the distal end 5) which is crossed and embraces the distal tip of the endoscope; in particular, suitably, the distal portion of the tubular element 3 is configured in such a way as to have longitudinal flexibility such as to accommodate the longitudinal flexibility of the distal tip of the endoscope, and this in order not to hinder its motility.

Conveniently, the device 2 can comprise an apparatus for measuring and controlling the internal pressure of the kidney. In particular, this apparatus can include: - a first pressure sensor of the irrigation liquid introduced and which, preferably, is positioned on the passage (door) in correspondence with the connector 15 connected to irrigation means, and

- a second pressure sensor for the drainage liquids and which, preferably, is positioned at the opening 33 of the drainage channel 30. Advantageously, in a possible embodiment (see Fig. 9), at the distal end 5 of the tubular element 3, a pressure sensor 36 can be provided for detecting the internal pressure of the kidney. Conveniently, the pressure sensor 36 can be connected - for example by means of a cable 37 which crosses the tubular element 3 longitudinally until it comes out of the latter at its proximal portion 14 of the latter - with a measuring apparatus (not represented). In particular, the cable 37 has one end connected to the pressure sensor 36 while the other end, emerging from the tubular element 3, is associated with a connection 38 for a measuring apparatus. Preferably, inside the tubular element 3 a dedicated longitudinal duct can be provided, separated from the remaining part 31 of the internal lumen of the tubular element itself, for the passage/crossing of the cable 37 of the pressure sensor 36.

The pressure sensor 36 can be electronic or pneumatic. In particular, in the case of an electronic pressure sensor 36, the connection 38 is of the "jack" type or similar while the cable 37 is an electric cable, while in the case of the pneumatic pressure sensor 36, the connection 38 it can be of the “luer lock” type or similar, while the cable 38 is a hollow tube.

Advantageously, therefore, the device 1 allows not only to measure the endopyelic/intrarenal pressure but also to control/optimize it, in particular by balancing the incoming irrigation flows and the outgoing outflow.

Advantageously, the connectors 15, 43 and/or 32 can be of the "luer lock" or "luer- slip" type (male or female), or of the conical type, for example an elastic sheath or an elastic cap. Preferably, the connectors 15 and 43 of the tubular element 3 are angled with respect to the mouth 16 - for the introduction of the guiding element 4 and of the endoscope - which instead faces/aligned with the central portion 7 of the tubular element itself. The endoscope that can be inserted inside the tubular element 3 can be a flexible ureteronephroscope for kidney stones, a rigid or flexible cystoscope for bladder stones, a rigid ureteroscope for ureteral stones and a rigid or flexible nephroscope for kidney or ureteral stones.

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

Preliminarily, the patient is inserted - prior to the introduction of device 2 - a guide wire through the urethra and ureter. Then, once the guiding element 4 is inserted inside the tubular element 3 so that the distal end 41 of the first protrudes from the distal end 5 of the second, the inflation means are activated so as to introduce a fluid (liquid or gas), through the first channel 45, into the expandable element 50, to thus bring the latter into the first inflated condition (see Fig. 4). The device 2 thus prepared, and with the expandable element 50 in said first expanded condition, is inserted into the urethra and made to rise through the ureter following the guide wire which crosses the second channel 46 of the guiding element 4. Advantageously, during the insertion of the device 2 inside the patient's body, the expandable element 50 remains in the first expanded condition so as to have an ogive shape at the tip to cover the mouth of the distal end 5 of the tubular element 3, to allow an atraumatic access to the inside of the urethra and ureter.

Once the device 2 - in the configuration in which the guiding element 4 is completely inserted in the tubular element 3 so as to cause the exit of the distal end 41 of the first from the distal end 5 of the second, and in which the expandable element 50 is in the second expanded condition - it has been inserted up to the mouth of the kidney, and in particular up to the pyelo-ureteral joint, the inflation means are controlled so as to withdraw the fluid from the expandable element 50, deflating it and thus causing its passage from the first expanded (inflated) condition to the second retracted/contracted (deflated) condition.

The guiding element 4 and the guide wire are then extracted/extracted from the tubular element 3, thus leaving only the tubular element in place.

Having thus freed the internal lumen of the tubular element 3, the endoscope is introduced inside the tubular element itself by passing it through the proximal mouth 16 of the latter. The endoscope thus crosses the tubular element 3 longitudinally until its distal tip reaches the means 6 which precisely prevent the distal tip of the endoscope from coming out of the distal end 5 of the tubular element 3. In particular, preferably, the distal tip of the endoscope comes into abutment, and is thus retained/hooked, by the ring 60 provided at the distal end 5 of the tubular element 3. Conveniently, the means 6 can be shaped to couple with the shapes/profiles of the distal tip of various commercially available endoscopes. Conveniently, the mouth 16 is shaped, preferably a truncated cone shape, is configured to couple or in any case interact operatively with the corresponding proximal part of the endoscope. Conveniently, therefore, the tubular element may have various configurations of the mouth 16 or of the means 6 according to the specific endoscopes intended to be inserted in the tubular element 3.

Conveniently, once this configuration has been reached in which the endoscope is completely inserted inside the tubular element 3, the operator can further advance or move the endoscope and, at the same time, the tubular element will thus be dragged with the endoscope, and this also thanks to the mechanical action of the organ 17 which holds the endoscope in correspondence with the proximal 14 or central portion 7 of the tubular element 3.

Basically, in this configuration, an assembly formed by the tubular element 3 is obtained with the endoscope inserted inside it. Conveniently, the tubular element 3 can be connected with its connector 15 to irrigation means and, advantageously, the space inside the lumen of the tubular element 3 which is not occupied by the endoscope thus defines a passage channel/duct - preferably annular around the endoscope - for an irrigation stream. Conveniently, in a possible embodiment, the space inside the lumen of the tubular element 3 which is not occupied by the endoscope defines a space in which an irrigation pipe is inserted.

Advantageously, moreover, the organ 17 which holds the The endoscope also acts as a sealing gasket to prevent the irrigation flow from exiting the proximal portion 14 of the tubular element 3 from the proximal portion, a flow which can thus exit externally only from the distal end 5 of the tubular element 3. Advantageously, this allows to have an irrigation channel/duct that is external to the endoscope and that brings the irrigation flow exactly to the distal tip of the endoscope, as if it were a channel inside the endoscope, but with the advantage of being able to carry more flow than traditional channels defined inside the endoscope, and this because the available light is greater. Another advantage of the present solution is the possibility of using endoscopes without an irrigation channel or with the irrigation channel not usable as it is used for other purposes, preferably as an operating channel, for example for the laser fiber or for aspiration.

Another advantage of the present solution is the geometry of the annular channel - defined between the external walls of the endoscope and the internal walls of the tubular element 3 - which allows a more homogeneous diffusion of the flow in the external area in front of the distal tip of the endoscope and with a lower irrigation flow speed given the greater pruning of the canal. Furthermore, suitably, a lower flow velocity improves the management of any activity that must be performed in the part immediately in front of the distal tip of the endoscope, such as laser lithotripsy. Advantageously, moreover, by keeping the tubular element 3 stationary in position, the endoscope can be removed from the patient's body by sliding it - in the extraction direction (i.e. in the direction of approaching the distal tip of the endoscope towards the proximal portion 14) - inside the tubular element 3, thus allowing any fragments to be extracted and above all without the risk of injury to the ureter The present invention also relates to a kit for minimally invasive medical treatments, preferably for endourological treatments, comprising an endoscope and an introducer device as described above.

The present invention has been illustrated and described in some of its preferred embodiments, but it is understood that executive variations may be applied to them 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. Introducer device (2), in particular ureteral, to be used for minimally invasive medical treatments, preferably for endourological treatments, characterized by the fact of comprising: - a tubular element (3) intended to be inserted inside the patient's body to bring its distal end (5) in correspondence with the intervention site, preferably inside the kidney, and by the fact that:

- said tubular element (3) is configured to be crossed internally and longitudinally by an endoscope which is intended to be inserted inside said tubular element (3) so as to bring the distal tip of the endoscope in correspondence with the distal end of said tubular element (3),

- at the distal end (5) of the tubular element (3) means (6) are provided which are configured to prevent the distal tip of the endoscope from escaping from said distal end (5) and this without hindering or impeding the functions of the endoscope itself, - said tubular element (3) has an internal diameter which is greater than the external diameter of the endoscope which is intended to be inserted and to cross longitudinally the tubular element, so as to have within the same tubular element (3) a space between the internal walls of the tubular element (3) and the external walls of the endoscope to thus define an irrigation channel and/or for the insertion of an irrigation pipe. 2. Device according to claim 1 , characterized in that it comprises a guiding element (4) which is configured to be slidably inserted inside the tubular element (3) and also to be slidably extracted from the latter.

3. Device according to one or more of the preceding claims, characterized in that it comprises, in correspondence with a proximal (14) and/or central (7) portion of the tubular element (3), at least one organ (17) for holding the endoscope, once it has been inserted inside the tubular element (3).

4. Device according to the preceding claim, characterized in that said organ (17) comprises a sealing gasket for coupling with the endoscope which is intended to be inserted inside and to pass through the tubular element (3), to prevent so that the proximal portion (14) of the tubular element (3), what said endoscope is inserted inside the tubular element (3), results in fluid communication with the outside.

5. Device according to one or more of the preceding claims, characterized in that said tubular element (3) is configured to be fluidically connected with irrigation means and comprises a connector (15) for attachment of irrigation means. 6. Device according to one or more of the preceding claims, characterized in that the guiding element (4) comprises: - a distal end (41) which is intended to protrude from the distal end (5) of the tubular element (3),

- a second connector (43) for the attachment of inflating means,

7. Device according to one or more of the preceding claims, characterized in that it comprises, at said distal end (41) of the guiding element (4), an expandable element (50).

8. Device according to one or more of the preceding claims, characterized in that said expandable element (50) is in fluid communication with said second connector (43) by means of a longitudinal channel (45) defined inside the guiding element (4) and which is configured to switch between a first expanded condition, for the insertion of the device inside the patient's body, and a second retracted/contracted condition, to thus insert the guiding element (4) inside the tubular element (3) or to extract the guiding element (4) from the tubular element (3).

9. Device according to one or more of the preceding claims, characterized in that said expandable element (50) is configured so that: - in said first expanded condition, it has a greater radial bulk with respect to the minimum passage opening defined by the means (6),

- in said second retracted/contracted condition it has a smaller radial bulk with respect to the minimum passage opening defined by the means (6).

10. Device according to one or more of the preceding claims, characterized in that said expandable element (50) is configured in such a way that, when the expandable element

(50) is in said first expanded condition, it assumes a substantially ogive shape covering the wall of the distal end (5) of the tubular element (3).

11. Device according to one or more of the preceding claims, characterized in that said means (6) for preventing the distal tip of the endoscope from escaping from the distal end (5) of the tubular element (3) comprise at least one element configured to hook the distal tip of the endoscope.

12. Device according to one or more of the preceding claims, characterized in that said means (6), which are configured to block/prevent the advancement of the distal tip of the endoscope towards the outside of the distal end (5) of the tubular element (3) without thereby preventing and/or hindering said operating functions of the endoscope, they comprise a ring-shaped body (60) mounted at the distal end (5) of the tubular element itself.

13. Device according to the preceding claim, characterized in that said ring-shaped body (60) has a smaller diameter than the diameter of the distal end (5) of the tubular element itself.

14. Device according to one or more of the preceding claims, characterized in that said ring-shaped body (60) is fixed by means of radial septa (61) to the walls of the tubular element (3) at the distal end (5) of the tubular element itself.

15. Device according to one or more of the preceding claims, characterized in that said ring (60) and said radial septa (61) are configured to retain the distal tip of the endoscope without impeding or otherwise hindering the functions of the endoscope, such as in particular the lighting and/or vision functions of the endoscope itself.

16. Device according to one or more of the preceding claims, characterized in that said retention ring (60) for the distal tip of the endoscope is centered with respect to the center of the circular section that the tubular element (3) has at its distal end (5).

17. Device according to one or more of the preceding claims, characterized in that said retention ring (60) for the distal tip of the endoscope is off-center with respect to the center of the circular section that the tubular element (3) has at its distal end (5).

18. Device according to one or more of the preceding claims, characterized in that the tubular element (3) comprises, preferably inside it, a drainage channel (30) which is configured to be in fluid communication with suction means and which is provided of at least one opening (33) which is defined in proximity to the distal end (5) of the tubular element (3), to thus recover the excess liquid present near the distal end of the tubular element (3). 19. Device according to the preceding claim, characterized in that the drainage channel

(30) is defined between the internal walls of the tubular element (3) and a separation wall (34) which is fixed/integrated internally to the internal walls of the tubular element.

20. Device according to one or more of the preceding claims, characterized in that the drainage channel (30) is defined by a dedicated tube (35) which is housed inside the tubular element (3) and which is fixed/integral with the walls internal of said element.

21. Device according to one or more of the preceding claims, characterized in that it comprises an apparatus for measuring and controlling the internal pressure of the kidney.

22. Device according to the preceding claim, characterized in that said apparatus for measuring and controlling the internal pressure of the kidney comprises: - a first pressure sensor mounted at the connector (15) of the tubular element (3) which is connected to irrigation means, and

- a second pressure sensor mounted at the opening (33) of the drainage channel (30).

23. Device according to one or more of the preceding claims, characterized in that it comprises a pressure sensor (36) which is mounted at the distal end (5) of the tubular element (3) to thus detect the internal pressure of the kidney.

24. Device according to one or more of the preceding claims, characterized in that said tubular element (3) has an internal diameter which is approximately 3-6Fr greater, with respect to the external diameter of the endoscope which is intended to be inserted and to cross longitudinally the tubular element. 25. Device according to one or more of the preceding claims, characterized in that the proximal portion (14) comprises a mouth (16), of truncated cone shape, for the passage (alternatively) of the guiding element (4) and of the endoscope .

26. Device according to one or more of the preceding claims, characterized in that the guiding element (4) comprises a second through channel (46) which is open to the outside and which passes through the body (40) from side to side, and i.e. from the distal end (5) to the end of the proximal portion (42) in order to define a passage channel for a guide wire.

27. Device according to one or more of the preceding claims, characterized in that the drainage channel (30) is fluidly in communication with a third connector (32) for the attachment of suction means, said third connector (32) being provided at the proximal portion (14) of the tubular element (3) and preferably being mounted on a dedicated portion that departs from the proximal portion (14).

28. Device according to one or more of the preceding claims, characterized in that said irrigation channel/duct which is intended to be defined inside the tubular element (3) between the internal walls of the tubular element itself and the external walls of the tubular element (3) endoscope has a substantially annular section.

29. Kit for minimally invasive medical treatments, preferably for endourological treatments, characterized in that it comprises an endoscope and an introducer device according to one or more of the preceding claims.