WO2023002369A1

WO2023002369A1 - An improved endoscope

Info

Publication number: WO2023002369A1
Application number: PCT/IB2022/056644
Authority: WO
Inventors: Maurizio CASAROTTO; Filippo NIGRO
Original assignee: Fmp Biotechnologies S.R.L.
Priority date: 2021-07-20
Filing date: 2022-07-19
Publication date: 2023-01-26

Abstract

Endoscope (10) to be used for minimally invasive medical treatments, preferably for endourological treatments, characterized by the fact that it is disposable and includes: - a tubular element (11) comprising internally at least one channel (8) which is traversed by a tubular duct (4) which is longitudinally flexible and which internally defines a suction duct, - a connector (43) for the mechanical and fluidic connection with suction means, said tubular duct (4) being in fluidic connection with said connector (43) and thus defining a suction duct, - a handle (13), which is configured to be gripped by the operator, and also characterized by the fact that the endoscope itself comprises a gripping and control member (50) for moving the tubular duct (4) inside the tubular element (11) so as to vary the length of the distal portion (12) of the tubular duct (4) which protrudes from the distal tip (21) of the tubular element (11).

Description

AN IMPROVED ENDOSCOPE.

The present invention relates to an improved endoscope for minimally invasive medical treatments, preferably for endourological treatments.

Disposable digital flexible ureterorenoscopes have been known since the late 1980s, however their popularity has only recently occurred.

In particular, the reduction of their production costs and the improvement in performance have led to a greater diffusion of flexible disposable ureterorenoscopes in some important centers of reference for calculosis.

Furthermore, the problems related to the sterilization process of flexible reusable ureterorenoscopes and their link with the transmission of the infection among patients, as well as the growing awareness of their environmental impact, has led to a greater use and diffusion of flexible disposable ureterorenoscopes.

Several studies have shown that single-use flexible ureterorenoscopes are becoming more cost-effective, especially in centers with few cases to treat and in cases with a higher risk of damage than flexible reusable ureterorenoscopes. In fact, various studies have shown that reusable flexible ureterorenoscopes suffer damage that requires repair after being used in 10-25 cases. Once a ureteroscope has been repaired, it is more likely to be damaged again, requiring further repairs. The fragility of flexible reusable ureterorenoscopes can lead to significant repair costs over time, and this has led to a greater diffusion of disposable flexible ureterorenoscopes in some centers.

There are already several flexible disposable ureterorenoscopes on the market, including LithoVue from BostonScienti fi c, PU3022A from Pusen, Polyscope from Lumenis, Polydiagnost from Hallbergmoos, Semi-Flex Scope from Maxi fl ex, FlexoVue from Cook Medical, and Yc-FR-A from YouCare Tech. Various in vitro tests have shown that single-use flexible ureterorenoscopes have optics, deflection capabilities and working channel flow rates equivalent to reusable and more expensive ones.

In vivo tests of a single-use flexible ureterorenoscope (particularly the LithoVue) in 40 procedures found that operators rated the image quality as "good" or "very good" in 95% of cases. Maneuverability was also rated similarly in 90% of these cases. Another case study comparing the in vivo use of a disposable flexible ureterorenoscope (LithoVue) versus that of a reusable flexible ureterorenoscope (Olympus URF-P6) found comparable procedural results and complication rates. The study also found that the overall mean procedure time was 10 minutes shorter in cases using the single-use flexible ureterorenoscope. In addition, no differences were found in operative time, stone removal or possible complications. Currently, the known disposable flexible ureterorenoscopes - being made of different material compared to the reusable flexible ureterorenoscopes - have reduced mobility, in particular in terms of lateral flexibility, at their distal tip which is intended to be inserted inside the body of the patient. In addition, there is still a need to improve disposable flexible ureterorenoscopes in terms of comfort and maneuverability for the user.

US 2018/0110404 shows an endoscope insertion device in which the flexible tubular duct of the endoscope slides parallel and external to a support tube, and is associated with the latter by means of clamps. However, this solution is not fully satisfactory since the flexible tubular duct is located outside, and therefore unprotected.

US 2018/0289394 shows a multifunctional endoscope comprising an aspiration, irrigation, and material removal system.

US 2004/0182393 shows a control valve for an aspiration catheter.

US 2016/0100747 shows a rigid head to be inserted into the channel of an endoscope.

JP 2014/90847 shows a catheter comprising a cleaning system.

WO 2020/223429 shows an endoscope with a laser system for pulverizing stones.

However, these solutions are not fully satisfactory as they do not allow the tubular duct of the endoscope to be extended. The object of the invention is to obviate all these drawbacks by proposing a disposable endoscope for minimally invasive medical treatments, in particular endourological, which allows to overcome, at least in part, the drawbacks of the known solutions, in particular of the known disposable endoscopes.

Another object of the invention is to propose an endoscope which is improved and optimized with respect to traditional endoscopes.

Another object of the invention is to propose an endoscope with characteristics and / or performances comparable to those of reusable endoscopes.

Another object of the invention is to propose an endoscope which has performances in terms of maneuverability comparable or improved to those of reusable endoscopes a body, such as a stone.

Another object of the invention is to provide an endoscope in which various instruments used for endourological treatment can be inserted, such as a laser source for lithotripsy and / or a gripping instrument and / or a catheter for injection of substances.

Another object of the invention is to provide an endoscope which is particularly effective and, in particular, is capable of reaching even the most peripheral districts of the urinary tract. Another object of the invention is to realize an endoscope which has a high accuracy, reliability and safety.

Another object of the invention is to provide an endoscope which is multifunctional and which reduces surgical times.

Another object of the invention is to provide an endoscope 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 endoscope 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.

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 a disposable endoscope for minimally invasive medical treatments with the characteristics indicated in claim 1.

The present invention is here hereinafter further clarified in some of its preferred embodiments, given purely by way of non-limiting example with reference to the attached drawings, in which: figure 1a shows a schematic view of a first embodiment of the endoscope according to invention, figure 1 b schematically shows a section of the endoscope of fig. 1 a at its distal tip, figure 1c shows an enlarged detail of Figure 1a, figure 2a schematically shows a first embodiment of the endoscope according to the invention, figure 2b schematically shows a section of the endoscope of fig. 2a at its distal tip, figure 3a schematically shows a first embodiment of the endoscope according to the invention, figure 3b schematically shows a section of the endoscope of fig. 3a at its distal tip, figure 4a schematically shows a first embodiment of the endoscope according to the invention, figure 4b schematically shows a section of the endoscope of fig. 4a at its distal tip, figure 5a schematically shows a first embodiment of the endoscope according to the invention, figure 5b schematically shows a section of the endoscope of fig. 5a at its distal tip, figure 6a schematically shows a first embodiment of the endoscope according to the invention, and figure 6b schematically shows a section of the endoscope of fig. 6a at its distal tip.

As can be seen from the figures, the disposable endoscope 10 according to the invention, to be used for minimally invasive medical treatments, preferably for endourological treatments, comprises a tubular element 11 with longitudinal development and a handle 13.

As mentioned, the endoscope 10 is of disposable type (ie single-patient) and, in particular, it is made with plastic materials, such as: thermoplastic elastomers, polytetrafluoroethylene (PTFE) technopolymer, in high flexibility medical grade thermoplastic polymers, in polyurethane (PU), in polyethylene (PE).

Conveniently, the disposable endoscope 10 comprises, at the handle 13, a control (not shown) for deflecting the distal part of the tubular element 11, preferably for longitudinally deflecting the distal part of the tubular element 11 by an equal angle or less than +/- 275°.

In particular, the tubular element 11 comprises a distal tip - corresponding also to the distal tip 21 of the tubular element 11 - which is intended to be inserted into the patient's body during the endoscopic operation, while the handle 13 is associated with the proximal zone (which is opposite to the distal tip 21 ) of the tubular element 11. Conveniently, the tubular element 11 is flexible longitudinally, preferably along its entire longitudinal extension and / or at least in correspondence with its distal part. Conveniently, the tubular element 11 is a containment jacket / sheath.

Conveniently, the handle 13 is configured (in terms of shape and / or size) to be comfortably gripped, at least in part, by the hand of the surgical operator. Conveniently, the handle 13 can be crossed internally by the tubular element 11.

Conveniently, the handle 13 is integrated with the tubular element 11.

Conveniently, the tubular element 11 comprises one or more channels, operative and non-operative, which cross it along its longitudinal development. Conveniently, at least one channel can also at least partially cross the handle 13 to come out in correspondence with the latter. Conveniently, in a possible embodiment, at least one channel can be provided which protrudes externally (ie upstream or downstream) with respect to the handle 13.

The endoscope 10, preferably for endourological treatments, also comprises a tubular duct 4 which is inserted inside a first channel 8, preferably but not necessarily operative, of the endoscope itself. In particular, therefore, the first channel 8, which is internal to the tubular element 11, acts as a guide for the tubular duct 4, which therefore also slides inside the tubular element 11.

Conveniently, the endoscope 10 comprises also a connection element 40 which is integral with the endoscope 10. Preferably, the connection element 40 is positioned in correspondence with the handle 13 of the endoscope 10. In particular, the connection element 40 can be integrated into the endoscope 10, and in particular it can be obtained or be part of the handle 13, or it can be defined by a distinct and separate body which is fixed to the endoscope 10 at the handle 13. Conveniently, the connection element 40 can be fixed directly to the endoscope 10 or it can be fixed (ie made integral with) the latter indirectly, preferably by means of a further intermediate connection element. Advantageously, the further intermediate connection element can comprise a "Y" or "T" connection element (i.e. with three terminations) in which a first termination is fixed to the endoscope, a second termination is fixed to the connection element 40 while the third termination is in mechanical and fluidic connection with irrigation and / or suction means 93. Preferably, the connection element 40 is sealed with the inside of the tubular duct 4.

In particular, the tubular duct 4 comprises:

- a central portion 6 intended to pass through the entire channel 8 of the tubular element 11 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 tubular element 11, inserted in the patient's body, and this in order to be able to reach the target to be taken and / or retained,

- a portion 14 - which in operation is the proximal one and which is defined in correspondence of one end of the tubular duct 4 which is opposite to that in which the distal portion 12 is defined - which is intended to pass through, at least in part, the handle 13 of the endoscope 10.

In particular, therefore, the tubular duct 4 is mobile between:

- a first rest position in which its distal portion 12 is substantially inside the tubular element 11,

- a second working position in which its distal portion 12 is located, at least partially outside the tubular element 12.

Preferably, when the tubular duct 4 is in said first position, the tubular duct itself is substantially completely contained inside the tubular element 12.

Preferably, the tubular duct 4 is not connected to the tubular element 12, and, in particular, it is not connected to the tubular element 12 by clips, tapes, bands, interlocking means, or other connecting means. The connection element 40 also comprises a (first) connector 43 for the mechanical and fluidic connection with suction means (not shown) external to the endoscope 10. Conveniently, the suction means comprise a circuit with one or more pipes connected to a vacuum generator. Advantageously, the proximal portion 14 of the tubular duct 4 is in fluidic connection with the suction means (not shown), preferably external to the endoscope 10, but without there being a mechanical connection and / or direct contact between said proximal portion 14 and said suction means. In particular, for this purpose, the proximal portion 14 of the tubular duct 4 is not in contact, or in any case is spaced apart, from the connector 43 for the suction means.

The tubular duct 4 is substantially a catheter which is inserted through a channel 8 of the endoscope 10. The tubular duct 4 internally delimits an aspiration duct.

In a possible and preferred embodiment, the tubular duct 4 acts 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, pass through the endoscope 10 externally with respect to the tubular duct 4; in more detail, the fiber connected to the laser source, although external to the tubular duct 4, can be inserted inside the same channel 8 of the endoscope 10 in which the tubular duct 4 is inserted, or it can be inserted in a dedicated and different endoscope channel.

Alternatively, in another possible embodiment not shown, 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. In particular, the tubular duct 4 defines and constitutes the suction duct of the endoscope 10.

Preferably, the tubular duct 4 has a high longitudinal flexibility, substantially along its entire longitudinal development, and at the same time it has a high transversal non- deformability, ie it is able to maintain the lumen defined inside it unchanged even when this is subjected to contraction forces, due to internal aspiration. In a preferred and possible embodiment, 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 portions 12, and the proximal portion 14) is made of an elastomeric thermoplastic material, preferably a block copolymer obtained from polycondensation of a polyamide carboxylic acid (PA) and of a terminal alcohol polyether (PE), for example 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, the central portion 6 and the central 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 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 it can be joined - by technologies known to the skilled person - to the assembly defined by the central 6 and distal portion 12. 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 to 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, thus reducing or avoiding that the stresses arrived up 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, the proximal portion 14 can be made of a technopolymer, preferably a polyamide base, for example it is made of Grilamid nylon. More in detail, in some preferred and possible embodiments, 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 the polycondensation of a carboxylic acid and a polyamide (PA) (substantially forming a Nylon) 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.

In a possible and preferred embodiment, the tubular body that defines the central 4 and distal 12 portion is made of an elastomeric thermoplastic material, preferably a block copolymer obtained from the polycondensation of a carboxylic acid and a polyamide (PA) and of a polyether (PE) comprising a terminal alcohol group, for example it is made of 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 (not shown) can be provided to protect the distal portion 12 of the tubular duct 4 from the laser means inserted inside of 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 can comprise a metal tubular section, 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 and suitable metals or metal alloys. Conveniently, the metal tubular section consists of a small tube with continuous side walls (ie without holes or mesh parts). Conveniently, the metal tubular portion of the shielding element is inserted inside the distal portion 12 of the tubular duct 4 (in particular in the case in which the fiber connected to the laser source passes through the tubular duct 4 internally) 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 fiber 33 passes through the endoscope externally with respect to the tubular duct 4). Advantageously, the metal tubular 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 metal tubular 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 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.

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 element 40 comprises an internally hollow structure 41 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. Preferably, in some possible embodiments, the connection element 40 is made of the same material as the handle 13. As mentioned, the proximal portion 14 of the tubular duct 4 - directly or by means of an extension 44 integral with said proximal portion 14 - it is inserted inside or receives, at least in part, the structure 41 of the connection element 40 so as to be able to slide with respect to the structure itself. In particular, the proximal portion 14 of the tubular duct 4, or an extension thereof, is slidably inserted (see fig. 1a, 2a and 3a) inside the connection element 40 or it can be the connection element 40 which it is, in part, inserted inside the proximal portion 14 of the tubular duct 4, or an extension 44 of the latter. Conveniently, the sliding of the proximal portion 14 of the tubular duct 4 with respect to the connection element 40 also causes the central part 6 of the tubular duct 4 to slide inside the endoscope 10, thus also correspondingly varying the length of the distal portion 12 which enters and exits from the distal tip 21 of the tubular element 11. Conveniently, as mentioned, the connection element 40 also comprises said connector 43 - hereinafter also referred to as "connector" - for the mechanical and fluidic connection with the suction means external to the endoscope 10. Preferably, said connector 43 is an attachment connector for the suction means.

Conveniently, the connection element 40 defines and / or internally comprises a sliding chamber for the proximal portion 14 of the tubular duct 4 (see fig. 1a, 2a and 3a); alternatively, it is the proximal portion 14 of the tubular duct 4, or an extension thereof, which defines and / or internally comprises a sliding chamber for a portion of the connection element 40 (see fig. 4a, 5a and 6a).

Conveniently, as mentioned, the connection element 40 can be integrated into the handle or it can be made in an external element distinct from the handle 13 which is fixed inside an attachment seat provided / obtained in the handle itself of the endoscope 10, to thus make the connection element 40 integral with the endoscope itself; advantageously, for this purpose, the connection element 40 - and in particular its structure 41 - can be provided with traditional means for fixing the unit itself to the handle 13. Conveniently, the connection element 40 of the endoscope 10 is in fluid communication with the channel 8, which is crossed by the tubular duct 4, and is configured to be mechanically and fluidically connected with the suction means.

Conveniently, the attachment seat provided / formed in the endoscope 10 is in communication with the channel 8 of the tubular element 11, into which the tubular duct 4 is intended to be inserted, so that - once the connection 40 has been fixed to the endoscope - the unit itself can receive the proximal portion 14 of the tubular duct 4 and can thus be in fluid communication with said duct 4 and with the channel 8.

Preferably, the connection element 40 comprises a connector 43. In particular, the connector 43 for attachment to the suction means is mounted on the connection element 40 and, in particular, on the structure 41 of said unit, which is made of polymeric material more rigid than the tubular duct 4. This it is particularly advantageous as 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, 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, but is fluidically connected with the suction means by means of at least one element - such as for example the connection element - 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.

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

Advantageously, the connector 43 of the connection element 40 of the endoscope 10 is angled with respect to the channel 8 of the endoscope itself which is crossed by the tubular duct 4. The endoscope 10 also comprises a gripping and control member 50 to vary the length of the distal portion 12 of the tubular duct 4 which protrudes from the distal tip 21 of the tubular element 11. In particular, the endoscope 10 also comprises a gripping and control member 50 for moving the tubular duct 4 so as to vary the length of the distal portion 12 of the tubular duct 4 which protrudes from the distal tip 21 of the tubular element 11

Conveniently, the gripping and control member 50 is movable with respect to the remaining part of the endoscope 10 and, in particular, it is movable with respect to the connection element 40 and / or to the handle 13 and / or to the tubular element 11 of the endoscope 10. Preferably, the gripping and control member 50 is positioned in correspondence with the connection element 40 of the endoscope 10.

Preferably, the gripping and control member 50 is mounted on the handle 13 and / or on the connection element 40 of the endoscope 10.

The gripping and control member 50 is operatively associated with the tubular duct 4 so that the action of an operator on the organ itself, which is intended to be positioned and always - at least partially - outside the endoscope, causes the movement / sliding of the tubular duct 4 to the inside the 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 tubular element 11. 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.

In particular, the gripping and control member 50 is associated directly - or even indirectly - with the tubular duct 4, and in particular with its proximal portion 14, so as to be integral with them in translation and, preferably, so that the movement in rotation and / or translation of the member 50 causes the tubular duct 4 to slide along the channel 8 of the endoscope 10.

Preferably, the structure 41 of the connection element 40 and / or the handle 13 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, in a possible embodiment shown in the figures, the gripping and control member 50 can comprise a gripping portion 52 which is fixed to the tubular duct 4. Conveniently, the gripping portion 52 of the member 50 can have various shapes and / or arrangements in order to be able to comfortably and easily operated manually by the operator. Conveniently, the gripping and control member 50 can be a lever.

Conveniently, the connection element 40 - and in particular the structure 41 - is sealed closed. Conveniently, the connection element 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 element 40. In particular, the gripping and control member 50 is mounted hermetically on the structure 41 of the connection element 40 and, at the same time, in such a way that the gripping and control member can be moved, in particular, it is sliding with respect to the structure 41.

Conveniently, the member the gripping and control member 50 is mounted on the handle 13 and / or on the connection element 40 and is slidable with respect to the handle itself and / or to the connection element 40. Preferably, the gripping and control member 50 is mounted tightly on the handle 13 and / or on the connection element 40 and, at the same time, so that the gripping and control member can be moved, in particular it is sliding, with respect to the handle itself and / or to the connection element 40. Preferably, in a possible embodiment shown in the figures, the gripping and control member 50 can be movable in translation with respect to the handle 13. Preferably, the gripping and control member 50 is a lever which moves / slides within a hollow seat formed in the handle 13 and / or within a cylindrical portion of the structure 41 of the connection element 40. Conveniently, the translation movement direction M of the gripping and control member 50 can be parallel or even angled with respect to the translation / sliding direction X of the tubular duct 4 inside the channel 8 of the endoscope 10.

Advantageously, in a possible embodiment not shown here, the endoscope 10 can be configured so that the direction of translation M of the gripping and control member 50 is parallel to the direction of sliding X of the tubular duct 4 inside the channel 8 of the endoscope itself. Conveniently, in a possible embodiment not shown in the figures, the gripping and control member 50 is movable in rotation with respect to the handle 13 and / or the connection element 40; in this case, for example, the gripping and control member 50 can be provided with a thread which engages with a corresponding counter-thread integral with the tubular duct 4 so that, by screwing / unscrewing the gripping and control member 50 with respect to the handle 13 and / or the connection element 40, the tubular duct 4 is caused to slide inside the channel 8 of the endoscope, thus varying the length of the distal portion 12 which protrudes from the distal tip 21 of the tubular element 11.

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 at its inner end (ie the end which is housed inside the structure 41) - it is mechanically and operationally associated with the proximal end of the tubular duct 4 by means of a connection element (cf. fig. 4a, 5a and 6a) thus defining the extension 44 of the proximal portion 14. Preferably, the extension 44 comprises a tubular body which is fixed to the proximal end of the tubular duct 4 and which is slidable within and with respect to the connection element 40. Preferably, the gripping and control member 50 is fixed / integral with the connection element 44, which in turn is fixed / integral with the tubular duct 4. Conveniently, the connection element 44 is made of a more rigid with respect to that of the tubular duct 4 and, preferably, can be made of the same material of which the connection element 40 is made.

Conveniently, in other possible embodiments not shown here, the suction means are fluidically and mechanically connected to the gripping and control member 50.

Preferably, the endoscope 10 according to the invention also comprises a cleaning tool 72 which can be inserted in a removable way inside of the connection element 40 and of the tubular duct 4 in order to clean or unblock the tubular duct 4.

In particular, the cleaning tool 72 comprises a rod 73 which can be removably inserted inside the tubular duct 4. Preferably, the diameter of the rod of the cleaning tool 72 is slightly lower than that of the internal lumen of the tubular duct 4.

Preferably, the cleaning tool 72 is made of metallic material, for example of steel or titanium or titanium alloys.

Preferably, the cleaning tool 72 also comprises a grip area 74 which has a larger diameter than the remaining part of the tool itself which is intended to pass through the tubular duct 4. Preferably, the cleaning tool 72 also comprises an area for fixing to the connector 43 of the connection element. Preferably, the fixing area corresponds to and / or is defined in correspondence with the grip area 74 of the cleaning tool 72.

Advantageously, the cleaning tool 72 is configured to be inserted inside the endoscope 10 by traversing in sequence the connection element 40 and then the tubular duct 4 until reaching the distal portion 12 of the latter. Conveniently, the cleaning tool 72 is introduced inside the endoscope by crossing the same connector 43 provided for the fluidic and mechanical connection with the suction means; therefore, to insert the tool 72 inside the tubular duct 4 which passes through the channel 8 of the endoscope 10, the suction means must be disconnected from the connector 43 and, correspondingly, the suction means can be connected to the connector 43 when it is cleaning tool 72 has been extracted from the tubular duct 4.

The endoscope 10 according to the invention can be provided with a single operating channel 8 (see fig. 1a and 4a) or with several operating channels (see fig. 2a, 3a, 5a, 6a), for example two operating channels, 8 and 83 respectively.

The tubular duct 4 which acts as a suction duct is inserted or integrated inside a channel 8, which can be operative but also non-operative, of the endoscope 10.

Conveniently, the endoscope 10 comprises, at the distal tip 21 of the tubular element 11, at least one illumination source 84 (for example with LEDs) and / or at least one vision sensor 85, preferably with a video camera CMOS type or CCD.

The endoscope 10 also comprises one or more support channels, for example a channel 81 is provided for supply cables of the lighting source 84, and a channel 82 for supply and signal transmission cables for the vision sensor 85.

Conveniently, the endoscope 10 comprises cables and a connector (not shown) for powering the illumination source 84. Conveniently, the endoscope 10 comprises cables and a connector (not shown) for powering the vision sensor 85 and for transmitting the signals acquired by the vision sensor itself.

Advantageously, the endoscope 10 can comprise only a first operating channel 8 which is crossed by the tubular duct 4 (see fig. 1a and 4a) or it can also comprise a further / second operating channel 83 (see fig. 2a, 3a, 5a and 6a) for irrigation or the introduction of grasping tools, such as baskets, to capture and retain the stone or any foreign body, in order to facilitate its extraction from the urinary excretory tract, or to introduce dedicated forceps for perform biopsies, or to introduce a catheter for injection of substances in order to perform a topical treatment, for example chemotherapy, hemostatic, contrast, drainage or other.

Furthermore, the endoscope 10 can comprise (see Figs. 1a, 3a, 4a and 6a) a dedicated channel 90 for the laser means and, in particular, for the fibers 33 connected to a laser source. For example, the endoscope 10 may 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 disposable endoscope 10 according to the invention clearly follows from what has been previously described.

Conveniently, the connector 43 of the connection element 40 is connected to the suction means. At this point, the surgeon / operator can maneuver the endoscope 10 until the stone is reached and, once reached, the suction flow is activated through the tubular duct 4 to attract and then hold the stone, or other target to be moved during endoscopic treatment, at the end of the distal portion 12 of the tubular duct 4.

Advantageously, during use, the surgical operator can, if necessary, vary the length of the distal portion 12 of the tubular duct 4 which protrudes from the distal tip 21 of the tubular element 11 simply by acting on the gripping and control member 50, for example making it slide towards M1 (see fig. 4a) or away M2 (see fig. 4b) with respect to the connection element 40 and / or the handle 13, thus causing a greater or lesser outflow of the distal portion 12 respectively of the tubular duct from the distal tip 21 of the tubular element 11.

Furthermore, if it is necessary to release and remove the fragment from the distal end of the tubular duct 4, and therefore from the distal tip 21 of the tubular element 11, it is sufficient to deactivate the suction flow through the tubular duct 4.

Therefore, again through the suction, the stone (or other target body) thus retained can be mobilized according to need or eventually to be extracted from the urinary excretory route. 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 tubular duct 4 which passes through and exits the canal 8 of the endoscope itself.

As mentioned, in the case of clinical indication, it is also possible to introduce into the endoscope 10 - inside the same tubular duct 4 or, inside the same channel 8 in which the tubular duct 4 is inserted but externally with respect to the duct itself, or still inside a different channel 90 with respect to that in which the tubular duct 4 is inserted - laser means comprising a fiber 33 connected to a laser source.

Advantageously, the insertion of the laser fiber 33 into the tubular duct 4 allows to carry out the lasertrissy of the stone. 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 excretory tract or to incise a soft tissue to be taken and analyzed ( e.g. for a biopsy). Advantageously, in a possible use of the endoscope 10, the tubular duct 4 which is in fluidic connection with the suction means 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 10, while an incision is made with the laser means, to thus separate the soft tissue to be removed from the surrounding tissue.

Advantageously, within other operating channels 83 of the endoscope, irrigation can be carried out or gripping tools, such as baskets, can be introduced to capture and hold the stone or any foreign body, so as to facilitate its extraction from the urinary excretory route. Furthermore, as needed, dedicated pliers can be introduced into another channel of the endoscope 10 to perform biopsies. Advantageously, inside another channel of the endoscope, a catheter for injection of substances can be introduced in order to perform a topical treatment, for example chemotherapy, haemostatic, contrast, drainage or other. Conveniently, if the endoscope 10 has a double operating channel (see fig. 2a,

3a, 5a and 6a), the irrigation of the treated site occurs through a second dedicated operating channel 83, which is different from channel 8, preferably also operative, in which the tubular duct 4 is inserted. Conveniently, in the event that a fragment gets stuck, it is possible to detach the suction means from the connector 43, in order to insert a guide inside the tubular duct 4 or other means suitable for removing the fragment.

The endoscope according to the present invention is particularly advantageous in that, inside a channel 8, a tubular duct 4 is inserted or incorporated / integrated, the distal portion 12 of which protrudes from the distal tip 21 of the tubular element 11 in an adjustable way in length by acting on the gripping and control member 50 of the endoscope itself which is operatively associated with the end or the proximal portion of the tubular duct 4. In particular, the length of the part of the distal portion 12 of the duct 4 that protrudes from the end distal endoscope is adjustable and, preferably, can be varied by acting on the gripping and control member 50 which is movable with respect to the handle 13 and / or to the connection element 40 which is fixed or integrated in the endoscope 10. From what has been said shows that the disposable endoscope 2, according to the invention, preferably endourological, is particularly advantageous in that the presence of the tubular duct, which is adjustable in length within a channel of the endoscope itself, allows to increase the mobility and maneuverability of the endoscope at its distal tip 21.

The endoscope according to the invention has been described and is particularly suitable for treatment of stone 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 tissues, carried out through the laser fiber that can be introduced inside the endoscope, or it can be used to attract and hold a soft tissue to be taken and analyzed (for example for a biopsy) while with the laser fiber a appropriate incision.

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. Endoscope (10) to be used for minimally invasive medical treatments, preferably for endourological treatments, characterized by the fact that it is disposable and includes:

- a tubular element (11) comprising internally at least one channel (8) which is traversed by a tubular duct (4) which is longitudinally flexible and which internally defines a suction duct,

- a connector (43) for the mechanical and fluidic connection with suction means, said tubular duct (4) being in fluidic connection with said connector (43) and thus defining a suction duct, - a handle (13), which is configured to be gripped by the operator, and also characterized by the fact that the endoscope itself comprises a gripping and control member (50) for moving the tubular duct (4) inside the tubular element (11) so as to vary the length of the distal portion (12) of the tubular duct (4) which protrudes from the distal tip (21 ) of the tubular element (11).

2. Endoscope according to claim 1, characterized in that said tubular duct (4) comprises:

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

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

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

- a connection element (40) which is configured to be fixed to the handle (13) or to be integrated in the handle (13) and which is crossed, at least in part, by said proximal portion (14), or by one of its extension (44), of the tubular duct (4) that protrudes from the tubular element (11),

3. Endoscope according to the preceding claim, characterized in that said connection element (40) comprises said connector (43) for the mechanical and fluidic connection to suction means.

4. Endoscope according to one or more of the claims, characterized in that the gripping and control member (50) is operatively associated with the proximal end or portion (14) of the tubular duct (14), or with an extension thereof (44), and is movable with respect to the handle (13).

5. Endoscope according to one or more of the claims, characterized in that the gripping and control member (50) is operatively associated with the proximal end or portion (14) of the tubular duct (14), or with an extension thereof (44), and is movable with respect to the connection element (40).

6. Endoscope according to one or more of the preceding claims, characterized in that, at the distal end of the tubular duct (4), a shielding element is provided, preferably defined by a metal tubular section, to thus protect the distal portion (12) of the tubular duct (4) by laser means which pass through the tubular element (11 ).

7. Endoscope according to the previous claim, characterized in that said shielding element comprises a metal tubular portion which is inserted inside the distal portion (12) of the tubular duct (4) and / or is associated externally with the distal portion (12).

8. Endoscope according to one or more of the preceding claims, characterized in that said connection element (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 than that of said tubular duct (4).

9. Endoscope according to one or more of the preceding claims, characterized in that it comprises a cleaning tool (72) which can be removably inserted inside the connection element (40) and the tubular duct (4) in order to clean or unblock the tubular duct (4).

10. Endoscope according to the preceding claim, characterized in that said cleaning tool (72) comprises:

- a rod (73) which can be removably inserted into the tubular duct (4), - a grip area (74) which has a larger diameter than the remaining part of the instrument itself which is intended to pass through the tubular duct (4), and

- a fixing area to the connector (43) of the connection unit (40).

11. Endoscope according to one or more of the preceding claims, characterized in that said tubular element (11) comprises a dedicated channel (90) for the laser means, preferably for at least one fiber (33) connected to a laser source, said dedicated channel (90) for the laser means being distinct and separated from the channel (8) which is crossed by said tubular duct (4).

12. Endoscope according to one or more of the preceding claims, characterized in that said tubular element (11) comprises a dedicated channel (90) for the laser means, preferably for at least one fiber (33) connected to a laser source.

13. Endoscope according to the preceding claim, characterized in that said dedicated channel (90) for the laser means coincides with said channel (8) which is crossed by said tubular duct (4).

14. Endoscope according to one or more of the preceding claims, characterized in that said tubular element (11 ) comprises:

- a channel (81) for lighting, preferably for supply cables of a lighting source (84), and / or - a channel (82) for the vision sensor (85).

15. Endoscope according to one or more of the preceding claims, characterized in that said tubular element (11) comprises a single operating channel which is defined by said channel (8) which is crossed by said tubular duct (4).

16. Endoscope according to one or more of the preceding claims, characterized in that said tubular element (11) comprises a first operating channel, which is defined by said channel (8) which is crossed by said tubular duct (4), and a further / second operating channel (83), preferably for irrigation and / or for the introduction of grasping instruments and / or a catheter for injection of substances.

17. Endoscope according to one or more of the preceding claims, characterized in that it comprises, preferably in correspondence with the handle (13), a control for deflecting said distal part of said tubular element (11), preferably for longitudinally deflecting the distal part of the element tubular (11) of an angle equal to or less than +/- 275°.

18. Endoscope according to one or more of the preceding claims, characterized in that said tubular duct (4) is movable between:

- a first rest position in which its distal portion (12) is substantially inside the tubular element (11),

- a second working position in which its distal portion (12) is at least partially outside the tubular element (11).

19. Endoscope according to one or more of the preceding claims, characterized in that the gripping and control member (50) is movable with respect to the tubular element (11) of the endoscope itself.

20. Endoscope according to one or more of the preceding claims, characterized in that said central portion (6) and said distal portion (12) of said tubular duct (4) are made in a single body and of the same polymeric material, while said proximal portion (14) is made of a different polymeric material, preferably having a greater rigidity.

21. Endoscope according to one or more of the preceding claims, characterized in that the distal portion (12) of the tubular duct (4) comprises a frusto-conical termination which widens outwards so as to define a greater useful surface at the distal end for coupling with the target to be treated.

22. Endoscope according to one or more of the preceding claims, characterized in that the connection element (40) defines and / or internally comprises a sliding chamber for the proximal portion (14) of the tubular duct (4).

23. Endoscope according to one or more of the preceding claims, characterized in that the proximal portion (14) of the tubular duct (4), or an extension thereof, defines and / or internally comprises a sliding chamber for a portion of the connection element (40).

24. Endoscope according to one or more of the preceding claims, characterized in that the gripping and control member (50) is associated with the tubular duct (4), and in particular with its proximal portion (14), so as to be integral with them in translation and, preferably, so that the translation movement of the member (50) causes the tubular duct (4) to slide along the channel (8) of the endoscope (10).

25. Endoscope according to one or more of the preceding claims, characterized in that the proximal portion (14) of the tubular duct (4) is not in contact with, or in any case at a distance, from the connector (43) for the suction means.