ENDO-URETHRAL VALVE

DESCRIPTION

Field of the invention [0001] The present invention relates to an endo-urethral valve, i.e. to an artificial endo-urethral sphincter, to be used by male patients suffering from urinary incontinence.

[0002] More in detail, the invention relates to an endo-urethral valve configured to resiliently open under the effect of a compression force applied by the patient on his own penis at the position of the implant of the endo- urethral valve, in order to allow the urine to flow through the urethra and to empty the bladder, the endo-urethral valve also configured to resiliently close upon releasing the compression force.

Prior art [0003] Several endo-urethral valves are known for patients suffering from urinary incontinence. These devices are used when such therapies as drug treatments and pelvic muscle re-education cannot solve the problem.

[0004] US 4,968,294 describes an endo-urethral valve made of silicone and comprising a tubular urine inlet end portion and a tubular outlet end portions aligned to each other along a longitudinal axis of the endo-urethral valve. Between the inlet and outlet end portions, a substantially spherical central hollow portion is provided communicating with the inlet and outlet end portions through urine inlet and outlet passages, respectively. The central portion contains a stopper portion comprising two sealing lips. The sealing lips symmetrically protrude from respective regions of the inner wall of the central hollow portion close to the outlet passage and extend towards the inlet passage of the spherical central hollow portion. In a closed undeformed configuration, at the inlet passage, the two lips are in contact to each other along a contact line. By applying a compression force to the central hollow portion in the direction of the contact line, the sealing lips are spread apart from each other, and the endo-urethral valve is brought to an open configuration, in which the two end portions of the endo-urethral valve are in communication with each other, allowing the urine to flow through the endo- urethral valve. [0005] A similar stopper arrangement is described in US 4,932,938, in which converging lips are made integral to an externally-protruding manoeuvrable cuff portion of a junction member joining two tubular portions of an endo-urethral valve.

[0006] US 7,008,372 describes an endo-urethral valve comprising a first cylindrical case part configured to engage with the inner urethra walls and a smaller second cylindrical case part arranged coaxially and in hydraulic connection of the first case portion, as a longitudinal extension thereof. A stopper body is arranged within the second case part and includes a cylindrical montage portion fluid-tightly mounted within the second case part and a stopper portion comprising a plurality of walls extending from the montage portion within the second case part towards the first case part. The walls converge to form a normally closed cross-shaped slit that can be opened by compressing the second case part of the endo-urethral valve from outside.

[0007] In the above prior art endo-urethral valves, the stopper portion includes a couple of relatively thin resilient lips forming a sort of duckbill pointing to the proximal portion of the endo-urethral valve, i.e. to the inlet of the urine. Due to this arrangement, the urine pressure insisting on the inlet side of the lips must be overcome in order to open the endo-urethral valve.

[0008] Another endo-urethral valve is described in US 5,800,339. In this case, however, a silicone flat disc-shaped stopper portion is provided comprising a peripheral ring fluid-tightly mounted in the central portion of the endo-urethral valve, and a plurality of circular sector-shaped stopper elements extending from the peripheral ring towards the longitudinal axis of the endo- urethral valve along a plane containing the peripheral ring. In a closed undeformed configuration, the stopper elements are fluid-tightly adjacent to one another thus blocking any urine flow through the endo-urethral valve. By compressing the central portion at the peripheral ring, the stopper elements change their shape and move away from the plane of the peripheral ring, thus creating an opening that connects the two end portions to each other and the endo-urethral valve is so brought to an open configuration.

[0009] US 6,022,312 describes an endosphincter comprising a fastening part to be connected at an inner position of the urethra close to the natural sphincter, and a hollow cylindrical valve body distally extending from the fixing portion to be arranged within a distal portion of the urethra. The valve body includes a stopper comprising sealing lips that, also in this case, can be resiliently brought from a closed undeformed configuration to an open deformed configuration by externally compressing the valve body, through the tissues of the penis.

[0010] Other endo-urethral valve devices are described in WO 2014/090227, US 5,954,766 and US 2017/020645.

Technical problems

[0011] The above prior art endo-urethral valves of the technique have at least one of the drawbacks described hereinafter.

[0012] Firstly, even if the patient is able to identify the position of the valve body within the penis, i.e., the position at which he has to press to open the device, it can be hard to him to find out the direction according to which the compression force must be applied. This is the case for substantially all the above-described devices that have an externally axisymmetric valve body.

[0013] Moreover, the endo-urethral valves of US 4,968,294, US 4,932,938 and US 7,008,372 include a stopper structure formed by such thin wall stopper elements as lips converging towards the inlet portion of the device and normally kept at an edge-to-edge contact to each other along a seal line. In this condition, a substantially unidimensional seal is formed between the stopper elements, which bend therefore according to a substantially unpredictable elastic collapse mode whenever an opening compression force is applied from the outside.

[0014] Moreover, several prior art endo-urethral valves are constructionally complicate, in particular the device described in US 6,022,312, in which the valve body is conceived to extend, in use, for about the whole length of the patient’s urethra, but also the endo-urethral valves of US 4,968,294 and US7,008,372. These devices are rather difficult to be obtained with such common forming techniques as injection moulding.

[0015] Another issue of some of the prior art devices is that a urine residue is likely remain upstream of the stopper portion thereof after the use, from which solid particulate matter can be formed in some non-drainable portions of the valve body. This is the case, for instance, of the devices described in US 4,968,294 and US 7,008,372.

[0016] The need is therefore felt of an endo-urethral valve of the type specified at the beginning of this application that overcomes the above- mentioned issues, and that can also be easily introduced and extracted into/from the urethra, in particular, if the device has to be replaced for some reasons.

Summary of the invention

[0017] It is therefore an object of the present invention to provide an endo- urethral valve configured to be resiliently opened by a compression force applied by a patient on his penis at the position where the endo-urethral valve is implanted, and configured for resiliently return to the closed configuration, that overcomes the technical problems described above.

[0018] In particular, it is an object of the present invention to provide such an endo-urethral valve that can be easily operated by the patient.

[0019] It is also an object of the invention to provide such an endo-urethral valve that is constructionally simple and that can therefore be manufactured at a relatively low production cost.

[0020] It is another object of the invention to provide such an endo-urethral valve that can be easily drained, thus avoiding substantially any residue of urine and accumulation of sediments after the use.

[0021] A further object of the invention is to provide such an endo-urethral valve that is easy to be introduced and extracted from the urethra by the surgeon, without any risks to break the endo-urethral valve within the urethra. [0022] It is also an object of the invention to provide a method to manufacture such an endo-urethral valve.

[0023] These and other objects are achieved by an endo-urethral valve as defined by independent claims 1 and 15, and by a method to manufacture such an endo-urethral valve according to independent claims 21 and 22. Advantageous exemplary embodiments of the device are defined by the dependent claims.

[0024] According to one aspect of the invention, an endo-urethral valve comprises: a proximal tubular portion and a distal tubular portion arranged along a common longitudinal axis and configured to anchor within a male patient’s urethra and allow a urine to flow therethrough; a central portion arranged between the proximal tubular portion and the distal tubular portion and configured to be pressed by the patient, in order to resiliently change from a closed undeformed configuration to an open deformed configuration, in which the central portion fluid-tightly separates or hydraulically connects, respectively, the proximal tubular portion and the distal tubular portion, wherein the central portion of the endo-urethral valve, in the closed undeformed configuration, has a central transversal dimension radially changing between a maximum central transversal dimension and a minimum central transversal dimension shorter than said maximum central transversal dimension, wherein the central portion includes a solid stopper body having a proximal side and a distal side mutually spaced apart along the common longitudinal axis of the proximal and distal tubular portions, i.e., the longitudinal axis of the endo-urethral valve, said proximal side and distal side being spaced apart by a longitudinal extension of the solid stopper body, wherein the solid stopper body includes a through slit extending for all the longitudinal extension between the proximal side and the distal side of the solid stopper body, i.e. between one end portion thereof facing the proximal portion and another end portion facing the distal portion, the through slit having walls mutually facing, wherein the walls - in the closed undeformed configuration, are fluid-tightly in contact to each other along the longitudinal extension of the stopper body; are configured to become spaced apart from each other forming a tubular duct along all said longitudinal extension when the central portion changes from the closed undeformed configuration to the open deformed configuration.

[0025] Thanks to the variable central transversal dimension, the patient can easily find out in which radial direction he has to press his penis in order to open the endo-urethral valve, without making several attempts, which would be discomfortable.

[0026] Moreover, the longitudinal extension of the stopper body allows the stopper body to be deformed in a more predictable way upon pressing it from outside, forming a tubular passage or duct having a predetermined length, and the stopper body is more likely to return to its original configuration upon releasing the external compression, without unexpected reclosure errors.

[0027] Thanks to the solid stopper body and the slit along all its longitudinal extension, when the patient presses the resilient solid cylindrical segment in a plane containing the slit, the slit turns from a configuration in which the walls are in contact with each other fluid-tightly, to a configuration in which the walls form a tubular duct, which permits the passage of urine. The user can simply press his penis using two fingers, thus obtaining such deformation.

[0028] Advantageously, the central portion consists of a resilient solid cylindrical segment having the longitudinal extension and having the through slit extending for all the longitudinal extension arranged in such a way that, when the patient presses the resilient solid cylindrical segment in a plane containing the slit, the slit turns from a configuration in which the walls are in contact with each other fluid-tightly, to a configuration in which the walls form the tubular duct. [0029] Two ways to obtain the variable central transversal dimension of the central portion of the endo-urethral valve are described hereinafter, in connection to corresponding non-limitative embodiments of the stopper body. [0030] In an exemplary embodiment of the stopper body, an outer surface of the central portion has a couple of diametrically opposite protrusions with respect to the longitudinal axis, the protrusions having respective top portions at a predetermined height with respect to an outer surface of the central portion, a diametrical distance between the top portions providing the maximum central transversal dimension. In particular, the protrusions extend parallel to the longitudinal axis of the endo-urethral valve to be more easily identified by the patient. A minimum non limitative practical value of the height of the protrusion, above the outer surface of the central portion, is about 1 mm.

[0031] According to another exemplary embodiment, the central portion of the endo-urethral valve is a biaxisymmetric central portion in which the shape of a cross section thereof has a major symmetry axis and a minor symmetry axis orthogonal to each other, said major symmetry axis providing said maximum central transversal dimension. In particular, the cross section is a substantially elliptical cross section. [0032] The form of the endo-urethral valve according to the above exemplary embodiments can be obtained in a relatively easy way by such conventional polymeric material forming techniques as moulding techniques, in particular by injection moulding.

[0033] Preferably, the through slit, in the closed undeformed configuration, has a linear cross section substantially aligned to the maximum central transversal dimension of the central portion of the endo-urethral valve. In particular, in the two above-mentioned exemplary embodiments, the cross- section of the slit is substantially aligned to the diametrically opposite protrusions of the central portion or is aligned to the major symmetry axis of the cross section of the central portion.

[0034] Such a shape and orientation of the cross-section of the slit make it easier to spread apart the walls of the slit and the assists a ready opening the endo-urethral valve under the action of the compression force by the patient on the central portion of the endo-urethral valve through the tissues of its own penis and the wall of the urethra. In fact, the compression force required to open the slit can be more easily and precisely predicted as the critical compressive force by exceeding which a condition of elastic instability of the slit is triggered, as in the case of the buckling of a compressed beam.

[0035] Preferably, the transversal size of the through slit, in the closed configuration, is set between 4 and 6 mm, i.e. large enough to allow an easy passage of urine when the through slit is opened to form a tubular duct by compression from outside. In particular, transversal size S is about 5 mm. [0036] Preferably, the longitudinal extension of the solid stopper body, which is also the longitudinal extension of the through slit, is longer than the transversal size of the through slit. Preferably, the length of the solid stopper body, which is also the longitudinal extension of the through slit, is set between 6 and 20 mm, i.e., large enough to be easily grasped by two fingers of the patient.

[0037] According to another aspect of the invention, the proximal tubular portion and the distal tubular portion have an end transversal dimension larger than the maximum central transversal dimension.

[0038] This way, the proximal and distal end portions of the endo-urethral valve can easily be stabilized at a predetermined position along the urethra, in other words, the larger size of proximal and distal end portions prevents the endo-urethral valve from migrating through the urethra, and to be possibly expelled therefrom.

[0039] Advantageously, the proximal tubular portion and the distal tubular portion have an axisymmetric shape, with respect to the longitudinal axis. In particular, at least the external surfaces of the proximal tubular portion and the distal tubular portion have a cylindrical shape. More in particular, the proximal and distal tubular portions comprise respective cylindrical shells. Such a shape is also preferred because it makes easier to insert/extract the endo-urethral valve into/from the patient’s urethra.

[0040] Moreover, such an endo-urethral valve can be housed in the patient’s urethra without particular discomfort to the patient. Even if the endo- urethral valve, once it has been introduced into the patient’s urethra, were to rotate about its own longitudinal axis, in particular if the outer surfaces of the end portions are cylindrical, the required compression force direction would be in any case easy to be identified by the patient when opening the endo-urethral valve.

[0041] Advantageously, between the central portion and the proximal and/or distal tubular portion(s), a proximal/distal tubular connection portion is provided having a cross-section that longitudinally change in a gradual way from an axisymmetric shape of the proximal and/or distal tubular portion(s) and the shape of the central portion having a major symmetry axis and a minor symmetry axis. [0042] In a further exemplary embodiment of the invention, the walls of the through slit, in the closed undeformed configuration, are fluid-tightly in contact to each other at a distal part of the longitudinal extension of the solid stopper body, whereas at a proximal part of the longitudinal extension of the solid stopper body, they are spaced apart from each other by a gap, and a width of said gap decreases towards the distal part.

[0043] In use, the above-mentioned gap is regularly filled with urine. Therefore, an increasing urine pressure is exerted on the lateral walls of the gap itself, i.e., on the proximal part of the mutually facing walls of the through slit. The urine pressure depends upon the amount of urine progressively accumulated in the bladder. When the amount of the urine accumulated in the bladder is such that a predetermined critical pressure value is reached in the gap, the endo-urethral valve automatically opens and a portion of the urine is released, until the pressure has fallen to a closing value below the critical pressure value, at which the endo-urethral valve closes again. As described more in detail hereinafter, in this exemplary embodiment, the elastic features of the stopper body, the shape of the gap and the depth thereof, i.e. the extension of the proximal portion of the through slit, where the walls are not in contact with each other even in the open configuration, are selected in such a way that the critical pressure value is reasonably higher than a discomfort pressure value at which a normal patient would decide to release urine, but no so high as a limit pressure value at which the patient’s bladder and urethra could be damaged. This way, an intrinsically safe endo-urethral valve is obtained, i.e. one in which an automatic emergency opening is provided controlled by the amount of the urine that is present in the bladder. This automatic endo-urethral valve can be advantageously used to treat a patient who is not able to open endo-urethral valve by himself, for instance, due to a cerebral disease or a therapy or a general anaesthesia or a similar condition, with no risk of bladder or urethra damage due to inner urine overpressure. In these cases, a catheter, not shown, is advantageously provided to remove the urine from the patient’s body.

[0044] In a further exemplary embodiment of the invention, the central portion comprises: an inner part integral to the proximal and distal portions, and an elastic constriction shell arranged about the inner part by a positive-fit connection on an outer surface of the inner part of the central portion, such that the walls of the through slit are maintained in contact to each other, wherein the elastic constriction shell: is configured to be externally pressed by the patient, so as to detach the walls of the through slit and to bring the endo-urethral valve from the closed undeformed configuration to the open deformed configuration; - when arranged about the inner part of the central portion, it has the central transversal dimension of the central portion radially changing between the maximum central transversal dimension and the minimum central transversal dimension.

This way, the reliability of the endo-urethral valve can be remarkably improved, since the closed configuration of the endo-urethral valve is assured by the compression forces applied by the elastic constriction shell, and does not depend on the operating conditions by which the body of the endo-urethral valve has been formed.

[0045] For example, the elastic constriction shell can be provided as a preformed elastic ring or sleeve arranged about the inner part of the central portion. As an alternative, the elastic constriction shell can be made integral to the inner part of the central portion of the endo-urethral valve, for instance, it can be overmolded about the inner part of the central portion.

[0046] In a further exemplary embodiment of the invention, a distal engagement element is arranged to be engaged by a positioning and extraction tool for positioning and/or extracting the endo-urethral valve into/from the patient’s urethra, the distal engagement element comprising: a fastening portion to the endo-urethral valve, incorporated in the distal portion of the endo-urethral valve, and - a grip portion configured to be gripped by the positioning and extraction tool.

This way, it is possible to easily introduce and extract the endo-urethral valve into/from the patient’s urethra in a minimally invasive way, thus reducing remarkably the discomfort to the patient. [0047] In particular, the grip portion distally protrudes from the distal portion of the endo-urethral valve, which makes it easier to hang the distal engagement element by the positioning and extraction tool.

[0048] Preferably, the fastening portion is perimetrically incorporated to said distal tubular portion of the endo-urethral valve, and the grip portion is arranged transversally to the endo-urethral valve between two diametrically opposite regions of the fastening portion. Advantageously, through holes are made through the fastening portion. This way, if the endo-urethral valve is manufactured by an injection moulding technique, the injected molten polymeric material passes through the through holes before hardening, thus improving the stability of the fastening portion incorporated in the polymeric material, once it has been hardened. The strength of the connection between the fastening portion of the distal engagement element and therefore the endo- urethral valve is therefore higher, which prevents any risk of detachment of the fastening element from the body of the endo-urethral valve, in particular, during the extraction of the endo-urethral valve.

[0049] The maximum overall transversal dimension of the endo-urethral valve, in particular a maximum diameter of the endo-urethral valve, excluding the maximum transversal dimension of the central portion, is preferably set between 3 mm and 12 mm, most preferably between 6 mm and 10 mm.

[0050] The length of the endo-urethral valve is preferably set between 20 mm and 50 mm, in particular between 30 mm and 40 mm, excluding a possible extension and or/stent extending from the proximal end portion to fix the endo- urethral valve within the bladder, at the inlet port of urethra, as described more in detail hereinafter.

[0051] Advantageously, the endo-urethral valve is made of a material selected from the group consisting of: a silicone i.e. a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinylchloride, an ethylene-vinyl acetate (EVA) copolymer or a derivative thereof, a thermoplastic elastomer, or a combination of the above materials, and said material is moulded in such a way that the walls of the slit, in a rest position, are in contact with each other with a positive pressure against each other. Most preferably, the endo-urethral valve is made of a silicone. In the exemplary embodiment in which the elastic constriction shell is provided, the latter can be made of a material selected from the group consisting of: a silicone i.e. a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinylchloride, an ethylene-vinyl acetate (EVA) copolymer or a derivative thereof, a thermoplastic elastomer, or a combination of the above materials, however, the elastic constriction shell is preferably made of the same material as the internal part and the rest of the endo-urethral valve.

[0052] According to another aspect of the invention, an endo-urethral valve comprises: a proximal tubular portion and a distal tubular portion arranged along a common longitudinal axis and configured to anchor within a male patient’s urethra and allow a urine to flow therethrough; a central portion arranged between the proximal tubular portion and the distal tubular portion and configured to be pressed by the patient, in order to resiliently change from a closed undeformed configuration to an open deformed configuration, in which the central portion fluid-tightly separates or hydraulically connects, respectively, the proximal tubular portion and the distal tubular portion, wherein the central portion includes a solid stopper body having a proximal side and a distal side mutually spaced apart along the common longitudinal axis of the proximal and distal tubular portions, i.e., the longitudinal axis of the endo-urethral valve, said proximal side and distal side being spaced apart by a longitudinal extension of the solid stopper body, wherein the solid stopper body includes a through slit extending for all the longitudinal extension between the proximal side and the distal side of the solid stopper body, i.e. between one end portion thereof facing the proximal portion and another end portion facing the distal portion, the through slit having walls mutually facing, wherein the walls in the closed undeformed configuration, are fluid-tightly in contact to each other along the longitudinal extension of the stopper body; are configured to become spaced apart from each other forming a tubular duct along all said longitudinal extension when the central portion changes from the closed undeformed configuration to the open deformed configuration. [0053] Advantageously, the central portion consists of a resilient solid cylindrical segment having the longitudinal extension and having the through slit extending for all the longitudinal extension arranged in such a way that when the patient presses the resilient solid cylindrical segment in a plane containing the slit, the slit turns from a configuration in which the walls are in contact with each other fluid tightly to a configuration in which the walls form the tubular duct.

[0054] Preferably, the transversal size of the through slit, in the closed configuration, is set between 4 and 6 mm, i.e. large enough to allow an easy passage of urine when the through slit is opened to tubular duct by compression from outside. In particular, transversal size S is about 5 mm.

[0055] Preferably, the longitudinal extension of the solid stopper body, which is also the longitudinal extension of the through slit, is longer than the transversal size of the through slit. Preferably, the length of the solid stopper body, which is also the longitudinal extension of the through slit, is set between 6 and 20 mm, i.e., large enough to be easily grasped by two fingers of the patient.

[0056] Advantageously, the endo-urethral valve is made of a material selected from the group consisting of: a silicone i.e. a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinylchloride, an ethylene-vinyl acetate (EVA) copolymer or a derivative thereof, a thermoplastic elastomer, or a combination of the above materials, and said material is moulded in such a way that the walls of the slit, in a rest position, are in contact with each other with a positive pressure against each other. Most preferably, the endo-urethral valve is made of a silicone. [0057] According to a further aspect of the invention, a method to make the above-described endo-urethral valve includes the steps of: forming a draft of the endo-urethral valve, the draft comprising the proximal tubular portion, the distal tubular portion and the inner part of the central portion, by a first step of injection-moulding a first polymeric material in a first mould comprising a first injection chamber, in which a longitudinal core member is fixedly arranged to provide the through slit; arranging the draft into a second mould comprising a second injection chamber configured to surround the inner part of the central portion when the draft is arranged in the second mould; forming an elastic constriction shell about the inner part of the central portion by a second step of injection-moulding a second polymeric material in the second mould, the second injection-moulding step carried out in such a way that the elastic constriction shell engages an outer surface of the inner part of the central portion by a positive-fit connection, such that the walls of the through slit are maintained in contact to each other, thus obtaining the closed configuration the endo-urethral valve.

[0058] In case an endo-urethral valve is made according to the invention in which no elastic constriction shell, a similar method can be carried out providing the following steps: forming a draft of the endo-urethral valve, the draft comprising the proximal tubular portion, the distal tubular portion and the central portion, - injection-moulding of a polymeric material in mould comprising an injection chamber, in which a longitudinal core member is fixedly arranged to provide the through slit; extracting the longitudinal core member obtaining the closed configuration C of the endo-urethral valve.

Brief description of the drawings

[0059] The invention is shown hereafter through the description of some exemplary embodiments, exemplifying but not limitative, with reference to the attached drawings, in which like reference characters designate the same or similar parts, throughout the figures of which:

Figs. 1 and 2 diagrammatically show an endo-urethral valve arranged along the urethra of a patient, respectively in a closed configuration and in an open configuration;

Fig. 3 and 4 are two perspective views diagrammatically showing an endo-urethral valve according to a first exemplary embodiment of the invention, in a closed configuration;

Fig. 5 is a diagrammatical side elevational view of the endo-urethral valve of Figs. 3 and 4;

Figs. 6 and 7 are diagrammatical cross-sectional views of the endo- urethral valve of Figs. 3 and 4, the sectional planes being indicated by the lines A-A and B-B of Fig. 5, respectively; Fig. 8 is a diagrammatical perspective view of the endo-urethral valve of Figs. 3 and 4, in an open configuration;

Fig. 9 is a diagrammatical side elevational view of the endo-urethral valve in the open configuration of Fig. 8; - Figs. 10 and 11 are diagrammatical cross-sectional views of the endo- urethral valve in the open configuration of Figs. 8 and 9, the sectional planes being indicated by the lines A-A and B-B of Fig. 9, respectively;

Fig. 12 is a diagrammatical perspective view of an endo-urethral valve according to a second exemplary embodiment of the invention; - Figs. 13 and 14 are two diagrammatical side views of the endo-urethral valve of Fig. 12, the sectional planes being orthogonal to each other;

Figs. 15, 16 and 17 are diagrammatical cross-sectional views of the endo-urethral valve of Fig. 12, the sectional planes being indicated by the lines C-C, D-D, E-E of Fig. 14, respectively; - Figs. 18, 19 and 20 show a diagrammatical perspective view a diagrammatical side view of the endo-urethral valve of Figs. 12-17, in an open configuration;

Figs. 21 , 22 and 23 are diagrammatical cross-sectional views of the endo-urethral valve of Fig. 12, in the open configuration of Figs. 19 and 20, the sectional planes being indicated by the lines C-C, D-D, E-E of Fig.

20, respectively;

Figs. 24 and 25 are diagrammatical cross-sectional views of the endo- urethral valve of Fig. 12, the enlarged view of Fig. 25 showing the effect of the pressure forces applied by the urine contained in a proximal portion of the endo-urethral valve, in the closed configuration;

Figs. 26 and 27 are diagrammatical cross-sectional views of an endo- urethral valve according to a third exemplary embodiment of the invention, the enlarged view of Fig. 27 showing the effect of the pressure forces applied by the urine contained in a proximal portion of the endo- urethral valve, in the closed configuration;

Fig. 28 is a diagrammatical longitudinal sectional view of an endo-urethral valve according to a fourth exemplary embodiment of the invention, the sectional plane passing through the central longitudinal axis, in a closed configuration of the endo-urethral valve; Figs. 29A and 29B are diagrammatical cross-sectional views of the central portion of the endo-urethral valve of Fig. 28, according to respective exemplary embodiments;

Fig. 30 is a diagrammatical longitudinal sectional view of the body of the endo-urethral valve of Fig. 28, without the outer constriction shell;

Figs. 31 A and 31 B are diagrammatical cross-sectional views of the central portion of the body of the endo-urethral valve of Fig. 29, according to the exemplary embodiments of Figs. 29A and 29B, respectively;

Figs. 32 and 33 are a diagrammatical side view and a diagrammatical bottom view of an endo-urethral valve according to a fifth exemplary embodiment of the invention, in which a distal engagement element is arranged to be engaged by a positioning and extraction tool of the endo- urethral valve;

Fig. 34 is a diagrammatical perspective view of the distal engagement element of Figs. 32 and 33;

Figs. 35 and 36 are diagrammatical perspective views of first and second moulds used to manufacture an endo-urethral valve according to the invention;

Figs. 37 and 38 diagrammatically show endo-urethral valves according to a sixth exemplary embodiment of the invention, in which the proximal tubular end portion comprises a tubular extension and a stent to be fixed within the patient’s bladder;

Fig. 39 diagrammatically shows the endo-urethral valve of Figs. 37 or 38 implanted within a male patient’s urethra, in a closed configuration; - Fig 40 is a cross-section of the central portion of the endo-urethral valve of Fig. 28, and of the inner part thereof before mounting the elastic constriction shell thereto;

Fig 41 is a cross-section of the central portion of the endo-urethral valve of Fig. 28, and of the elastic constriction shell thereof before being mounted thereto;

Fig. 42 is a cross-section of the central portion of the endo-urethral valve of Fig. 28, similar to the cross-sectional views of Figs. 40 and 41 , to explain the effect of the constriction forces applied thereto by the elastic constriction shell; Fig. 43 and 44 are two perspective views diagrammatically showing an endo-urethral valve according to another aspect of the invention, in a closed configuration;

Fig. 45 is a diagrammatical side elevational view of the endo-urethral valve of Figs. 43 and 44;

Figs. 46 and 47 are diagrammatical cross-sectional views of the endo- urethral valve of Figs. 43 and 44, the sectional planes being indicated by the lines A-A and B-B of Fig. 45, respectively;

Fig. 48 is a diagrammatical perspective view of the endo-urethral valve of Figs. 43 and 44, in an open configuration.

Description of preferred exemplary embodiments

[0060] Figs. 1 and 2 diagrammatically show an embodiment of an endo- urethral valve 6 according to the invention, implanted within a male patient’s urethra 98. In Fig. 1 , endo-urethral valve 6 is shown in a closed undeformed configuration C (Fig. 1), in which endo-urethral valve 6 prevents urine 90 from flowing out of patient’s bladder 99 through urethra 98. In Fig. 2, endo-urethral valve 6 is shown in an open configuration in which endo-urethral valve 6 allows urine 90 to flow through urethra 98.

[0061] Endo-urethral valve 6 is configured to be opened by a compression force F applied to endo-urethral valve 6 by the patient through the tissues of his own penis 97 and through the wall of urethra 98, and is also configured to resiliently close again upon releasing compression force F.

[0062] Figs. 3-48 show endo-urethral valves 1 , 2, 3, 4, 5, 7, 8, 9 according to different exemplary embodiments of the invention. Endo-urethral valves 1-9 comprise a proximal tubular end portion 10 and a distal tubular end portion 30 both arranged along a common longitudinal axis 11 and configured to anchor within urethra 98 (for example Figs. 1 , 2). Endo-urethral valves 1-9 also comprise a central portion 20 between tubular end portions 10 and 30. Central portion 20 is a stopper portion configured to elastically turn from a closed undeformed configuration C to an open deformed configuration O upon receiving compression force F from the patient. In closed undeformed configuration C, central portion 20 liquid-tightly separates proximal tubular portion 10 and distal tubular portion 30 from each other. In open deformed configuration O, central portion 20 hydraulically connects proximal and distal tubular portions 10 and 30 to each other. In certain embodiments tubular end portions 10 and 30 can be very short, like short protruding edges.

[0063] According to one aspect the invention, in closed undeformed configuration C, central portion 20 of endo-urethral valves 1 , 2, 3, 4, 5 has a transversal dimension radially changing between a maximum value D2 and a minimum value D1 shorter than D2, as shown in Figs. 6, 15, 29A.

[0064] As shown in Figs. 3, 5, 8, 10, 12, 15, 18, 21 , 24, 26, 29A-B, 31A-B central portion 20 includes a solid stopper body 21 having a proximal side 19 and a distal side 29 mutually spaced apart along longitudinal axis 11 by a longitudinal extension B of solid stopper body 21 , and facing proximal and distal portions 10, 30, respectively. Central portion 20 includes a through slit 22 extending between proximal side 19 and distal side 29 and defined by at least one couple of mutually facing walls 23. In closed undeformed configuration C, walls 23 are liquid-tightly in contact to each other along at least one part 27” of longitudinal extension B of stopper body 21 (Figs. 3, 5, 12, 15, 24, 26, 29A-B, 31A-B). Moreover, walls 23 are also configured to become spaced apart from each other along all longitudinal extension B when central portion 20 turns from closed undeformed configuration C to open deformed configuration O (Figs. 8, 10, 18, 21).

[0065] Different ways are possible to obtain the radially changing transversal dimension of central portion 20, such as a variable outer diameter thereof.

[0066] Figs. 3-6 show an endo-urethral valve 1 according to a first exemplary embodiment of the invention, in which the outer surface of central portion 20 has a couple of diametrically protrusions 24 opposite to each other with respect to longitudinal axis 11 of endo-urethral valve 1. Protrusions 24 have top portions 24’ at a predetermined height FI above the outer surface of central portion 20. Preferably, protrusion 24 extend parallel to longitudinal axis 11. Therefore, as shown in Fig. 6, central portion 20 has a transversal dimension changing from a minimum value D1 , at diameters away from protrusions 24, to a maximum value D2 = D1 + 2H, at a diameter passing through top portions 24’ of protrusions 24. Preferably the height of top portions 24' above the outer surface is longer than or at least equal to 1 mm. [0067] Any shape, position and orientation of through slit 22 is possible. However, the cross-section of silt 22 is preferably linear and has a transversal size S, in closed undeformed configuration C. Most preferably, as shown in Figs. 6, 15, 29A-B, linear slit 22 is substantially aligned to maximum transversal dimension D2 of central portion 20. In particular, the cross-section of slit 22 is aligned to the top portions of diametrically opposite protrusions 24 of central portion 20.

[0068] Preferably, transversal size S of slit 22, in closed configuration C, is set between 4 and 6 mm, i.e. large enough to allow an easy passage of urine when opened by compression from outside, in particular transversal size S is about 5 mm.

[0069] Preferably, length B of solid stopper body 21 , and therefore of through slit 22 is longer than transversal size S of through slit 22.

[0070] Preferably, length B of solid stopper body 21 , and therefore of through slit 22 is set between 6 and 20 mm.

[0071] Preferably, proximal and distal tubular end portions 10,30 are axisymmetric with respect to longitudinal axis 11 , in particular tubular end portions 10,30 have at least an outer cylindrical shape, as shown, for instance, in Figs. 3, 4, 12, 32, and possibly also an inner cylindrical shape. [0072] In an advantageous exemplary embodiment, as shows for instance in Fig. 13, proximal and distal tubular portions 10, 30 have an end transversal dimension T, in particular a diameter T, longer than the maximum central transversal dimension D2 of central portion 20.

[0073] As shown in Figs. 15 and 29A, central portion 20 can be a biaxisymmetric body, i.e. the cross-section of central portion 20 has as a biaxisymmetric shape. In other words, as indicated in Fig. 15, the cross section of central portion 20 has a major symmetry axis 26” and a minor symmetry axis 26’, in particular the axes are orthogonal to each other. In this case, slit 22 preferably has a linear cross section aligned to major symmetry axis 26”. For example, the cross section of central portion 20 can be a substantially elliptical shape.

[0074] Preferably, if the tubular end portions 10,30 have transversal dimensions larger than central portion 20, or if tubular end portions 10,30 have a cross-section different from the cross-section of central portion 20, endo- urethral valve 2 has a proximal/distal tubular connection portion 15,25 between central portion 20 and proximal/distal tubular end portion 10,30, as show for instance in Figs. 13,14,26,28. In this case, as indicated in Figs. 15-17, if tubular end portions 10,30 have a cylindrical shape, the cross-section of tubular connection portion 15,25 gradually turns by from a shape having a symmetry centre to a biaxisymmetric shape from proximal/distal tubular end portion 10, 30 to central portion 20.

[0075] Figs. 26 and 27 show an endo-urethral valve 3 according to a third exemplary embodiment, in which walls 23 of through slit 22, in closed undeformed configuration C, are fluid-tightly in contact to each other only at a distal part 27” of longitudinal extension B of stopper body 21, and a gap 28 is formed at a proximal part 27’, i.e. walls are at a distance S decreasing towards distal part 27”. Fig. 27 diagrammatically shows pressure forces P that urine 90 applies on the inner walls of proximal part 27’ and on walls 23 of slit 22. Urine pressure forces P are oriented in such a way to detach walls 23. If the amount of urine 90 within bladder 99 is large enough, and therefore the urine pressure in gap 28 exceeds a predetermined critical value, opening forces P applied on walls 23 exceeds the opposite elastic closing forces exerted by the material of stopper body 21 , so that walls 23 become detached from each other along the whole longitudinal extension 27’, 27” and endo-urethral valve 3 is brought to an open configuration, in which urine 90 is released.

[0076] By comparison, Fig. 25 diagrammatically shows endo-urethral valve 2 of Figs. 13 and 14, in which no gap is provided in the proximal part of through slit 22 and walls 23 of through slit 22, in the undeformed configuration C, are fluid-tightly in contact to each other along all longitudinal extension B of stopper body 21. In this case, pressure forces P are applied on the inner walls of proximal part 10 only. In this case, the sum of pressure forces P has a transversal component far weaker than in the case of endo-urethral valve 3 of Figs. 26 and 27, and a higher urine pressure is required to open the endo- urethral valve, or the endo-urethral valve could not be open by the urine pressure.

[0077] The shape of gap 28 and the length of proximal part 27’ of slit 22 are selected taking into account the elastic properties of the material of stopper body 21 , and in such a way that the above-mentioned critical pressure value is reasonably higher than a discomfort pressure value at which a normal patient would decide to release urine 90, but not so high as a limit pressure value at which the patient’s bladder 99 and urethra 98 could be damaged. Briefly, endo-urethral valve 3 automatically opens when the critical pressure value is reached, preventing an excessive pressure to damage the patient’s bladder 99 and urethra 98. This is useful, in particular, for a patient who is not able to open endo-urethral valve 3 by himself, for instance, due to a cerebral disease or a therapy or a general anaesthesia. In these cases, a catheter, not shown, is advantageously provided to remove urine from the patient’s body.

[0078] With reference to Figs. 28-31 B, an endo-urethral valve 4 is described according to a fourth exemplary embodiment of the invention. The endo-urethral valve 4 is made of two parts and comprises a draft 4’ and an elastic constriction shell 40 arranged about inner part 20’ of draft 4’, in order to maintain slit 22 and therefore endo-urethral valve 4 in closed undeformed configuration C, as shown in Figs. 28A-29. More in detail, central portion 20 of endo-urethral valve 4 comprises an inner part 20’ that is manufactured integrally with proximal and distal end portions 10,30, e.g., with proximal and distal connecting portions 15,25. Elastic constriction shell 40 is arranged on an outer surface of inner part 20’ by a positive-fit connection, such that walls 23 of through slit 22 are maintained in contact to each other. Normally, walls 23 cannot be in contact to each other in draft 4’ as manufactured.

[0079] Elastic constriction shell 40 is configured to be externally pressed by the patient, so as to detach walls 23 of through slit 22 from each other, thus causing endo-urethral valve 4 to resiliently change from closed undeformed configuration C to open deformed configuration O, not shown here but easily understandable by considering, for instance Figs. 20 and 21.

[0080] When arranged about inner part 20’ of central portion 20, the central transversal dimension of elastic constriction shell 40 changes between maximum central transversal dimension D2 and minimum central transversal dimension D1. This can be obtained, for instance, as shown in Fig. 29A, i.e. by fitting a non-uniform-thickness elastic constriction shell 40 about a cylindrical inner part 20’ of central portion 20, or by fitting a uniform-thickness constriction shell 40 about a non-uniform diameter inner part 20’ of central portion 20, such as an inner part 20’ having an elliptical cross section, so that elastic constriction shell 40 is deformed providing the desired uneven transversal dimension of central portion 20.

[0081] The effect of elastic constriction shell 40 on inner part 20’ of central portion 20 is shown in Fig. 40, consisting in a compression of inner part 20’ that is stronger in the direction perpendicular to through slit 22 than in the direction of through slit 22 itself, causing mutually facing walls 23 of through slit 22 to close. The elastic behaviour of biaxisymmetric elastic constriction shell 40 is depicted in Fig.41 , i.e. the diameter perpendicular to through slit 22 remain substantially unchanged, while it is shortened in the direction of through slit 22, upon mounting elastic constriction shell 40 about inner part 20’ of central portion 20. Fig. 42 shows the elastic constriction forces FM applied by elastic constriction 40 on inner part 20’ of central portion 20.

[0082] In any case, elastic constriction shell 40 can be made as a preformed elastic ring or sleeve having a predetermined inner size and a predetermined elasticity, which is then fitted about inner part 20’ by a positive- fit connection.

[0083] Figs. 32 and 33 show an endo-urethral valve 5 according to a fifth exemplary embodiment of the invention, in which a distal engagement element 50 is provided for a tool, not shown, to be used in order to position or extract endo-urethral valve 5 from the patient’s urethra 98 (Figs. 1 ,2), in particular, when replacing the endo-urethral valve. Distal engagement element 50 preferably comprises a fastening portion 51 incorporated or in any case integral in distal tubular end portion 30 of endo-urethral valve 5 and a grip portion 52 configured to engage with a positioning and extraction tool, not shown. The incorporation of fastening portion 51 in distal tubular end portion 30 can be carried out by prearranging distal engagement element 50 into a mould for manufacturing endo-urethral valve 5 by injection moulding. In this case, distal engagement element 50 can be made of a material different from the rest of endo-urethral valve 5, for example, of a metal or ceramic material, or of a plastic material having a softening point higher than the material of which the rest of endo-urethral valve 5 is formed. [0084] As an alternative, distal engagement element 50 can be made of the same material as endo-urethral valve 5, if this material is strong enough, by integral injection moulding in an appropriate mould, not shown.

[0085] Preferably, as shown in Fig. 33, grip portion 52 is arranged transversally, i.e. between two diametrically opposite regions of fastening portion 51 or of distal tubular end portion 30 of endo-urethral valve 5, in this case, grip portion 52 extends along a diameter of distal tubular end portion 30, and preferably protrudes out of distal tubular end portion 30, while fastening portion 51 is perimetrically incorporated in distal tubular end portion 30. [0086] Fig. 34 shows an exemplary embodiment of distal engagement element 50, in which through holes 55 are made in the fastening portion 51 , in order to assist anchoring of fastening portion 51 within the wall of distal tubular end portion 30. In this case, for instance, both fastening portion 51 of distal engagement element 50 and distal tubular end portion 30 have a cylindrical shape.

[0087] The overall or maximum transversal dimension K of the endo- urethral valve according to the exemplary embodiments of the invention, among which the ones shown in the drawings (Figs. 5, 13 and 14), in particular a maximum diameter K, is set between 3 mm and 12 mm, in particular between 6 mm and 10 mm.

[0088] Moreover, the endo-urethral valve according to the various exemplary embodiments of the invention has a length L (Figs. 5, 13 and 14) preferably set between 20 mm and 50 mm, in particular between 30 mm and 40 mm. [0089] The endo-urethral valve is made of a biocompatible material. This material can be selected from the group consisting of a silicone, i.e. a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinylchloride, an ethylene-vinyl acetate (EVA) copolymer or a derivative thereof, a thermoplastic elastomer, or a combination of these materials, but preferably the material of the endo-urethral valve is a silicone.

[0090] In particular, in the case of endo-urethral valve 4 of Figs. 28-31 B according to the fourth exemplary embodiment, elastic constriction shell 40 is made of a material selected from the group consisting of: a silicone, i.e. a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinylchloride, a thermoplastic elastomer, or a combination of these materials, but preferably the material of elastic constriction shell 40 is a silicone. [0091] In any case, elastic constriction shell 40 can be made in the same material as inner part 20’ of central portion 20 of draft 4’.

[0092] With reference to Figs. 37-39, endo-urethral valves 7,8 are described according to a sixth exemplary embodiment of the invention, in which proximal tubular end portion 10 of endo-urethral valve 7,8 can also comprise a tubular extension 17 and possibly a stent 18 of known type configured to be fixed within bladder 99, at the inlet port of urethra 98, as shown in Fig. 39. Tubular extension 17 can be integrally manufactured with the rest of endo-urethral valve 7,8 or can be mounted to a pre-formed endo- urethral valve after a forming step thereof, as a separate part. In this case, the rest of proximal portion 10 and tubular extension 17 comprise mutual connection means preferably of snap-fit type or positive engagement type.

[0093] In particular, in endo-urethral valve 8 of Fig. 38 according to an exemplary embodiment of the invention, stopper body 20 can extend up to the end of distal tubular end portion 30 and endo-urethral valve 8 can be configured to be cut at a cut line 20” to adjust the overall length of endo- urethral valve 8 to the length of patient’s urethra 98, so that stopper portion 20, when endo-urethral valve 8 is implanted, is present at a mid-section of the patient’s penis to be comfortably compressed by the patient and opened.

[0094] An endo-urethral valve 9 according to another aspect of the invention is basically shown in Figs. 43-48, including a proximal tubular end portion 10 and a distal tubular end portion 30 both arranged along a common longitudinal axis 11 and configured to anchor within urethra 98 (Figs. 1, 2). Endo-urethral valve 9 also comprise a central portion 20 between tubular end portions 10 and 30. Central portion 20 is a stopper portion configured to elastically turn from a closed undeformed configuration C (Fig. 43) to an open deformed configuration O (Fig. 48) upon receiving compression force F from the patient. In closed undeformed configuration C, central portion 20 liquid- tightly separates proximal tubular portion 10 and distal tubular portion 30 from each other. In open deformed configuration O, central portion 20 hydraulically connects proximal and distal tubular portions 10 and 30 to each other.

[0095] As shown in Figs. 43 and 45, central portion 20 includes a solid stopper body 21 having a proximal side 19 and a distal side 29 mutually spaced apart along longitudinal axis 11 by a longitudinal extension B of solid stopper body 21 , and facing proximal and distal portions 10, 30, respectively. Central portion 20 includes a through slit 22 extending between proximal side

19 and distal side 29 and defined by at least one couple of mutually facing walls 23. In closed undeformed configuration C, walls 23 are liquid-tightly in contact to each other along at least one part of longitudinal extension B of stopper body 21. Moreover, walls 23 are also configured to become spaced apart from each other along all longitudinal extension B when central portion

20 turns from closed undeformed configuration C to open deformed configuration O (Fig. 48). [0096] Any shape, position and orientation of through slit 22 is possible.

Flowever, the cross-section of silt 22 is preferably linear, in closed undeformed configuration C.

[0097] Preferably, proximal, central and distal tubular end portions 10,20,30 are axisymmetric with respect to longitudinal axis 11, in particular they have at least an outer cylindrical shape, as shown in the exemplary embodiment of Figs. 43, 44, and possibly also an inner cylindrical shape.

[0098] Exemplary embodiments of this aspect of the invention are possible, including additional features as those of endo-urethral valves 3 (Figs 26 and 27), 4 (Figs. 28-31 B), 5 (Figs. 32-34), 7 (Fig. 37) and 8 (Fig. 28). [0099] The endo-urethral valve of the invention can be manufactured by a process including injection moulding steps.

[0100] The present invention also includes a method to manufacture endo- urethral valve 4 (Figs. 28-31 B) according to an embodiment of the one aspect invention, as well as an endo-urethral valve, not shown, according to a corresponding exemplary embodiment of the other aspect of the invention, in particular, if constriction shell 40 is made integral to inner part 20’ of central portion 20, in particular, is overmolded about inner part 20’.. [0101] In facts, the method provides a first step of forming a draft 4’ by moulding, in particular by injection moulding. As described above, draft 4’ comprises proximal tubular portion 10, distal tubular portion 30 and an inner part 20’ of central portion 20. The first step of forming draft 4’ can be carried out in a first mould 60 as shown in Fig. 35, by an injection-moulding process of a first biocompatible polymeric material that is preferably a silicone, i.e. a polysiloxane, in particular polydimethyl siloxane, or even a material selected among polyurethanes, polyvinylchloride, thermoplastic elastomers, or a combination of at least two out of all these materials. [0102] The first mould 60 comprises two removable heads 62 and 63 and a couple of shell portions 66 arranged to form a first injection chamber 67 having for example a shape corresponding to the shape of endo-urethral valve 2, or of an endo-urethral valve according to any of the exemplary embodiments described herein. Mould 60 can be closed by conventional lock means such as screws, for which through holes 68,68’ are longitudinally made through heads 62,63 and shell portions 66, respectively.

[0103] Support elements 65 for a longitudinal core 61 extend within first injection chamber 67 from a central position of heads 62,63, so that longitudinal core 61 can be arranged within first injection chamber 67 while injection-moulding endo-urethral valve 2, in order to form slit 22. An injection channel 64 allows a polymeric material to be injected into first injection chamber 67. A means of conventional type is also provided for adjusting the temperature of first mould 60, as well as a conventional injection control means, not shown. [0104] In order to manufacture an endo-urethral valve such as endo- urethral valve 4 consisting of a draft 4’ and an of elastic constriction shell 40 made of two different materials, or even of a same material, draft 4’ is withdrawn from first mould 60 and then positioned into a second mould 70, as shown in Fig. 36, in order to carry out a step of forming elastic constriction shell 40 to complete the endo-urethral valve by injection moulding a second polymeric material.

[0105] Second mould 70 also comprises two heads 73, one of which only is shown for the sake of clearness, and shell elements 75, 76, which can be mounted to each other to define an inner space 71. The end portions of inner space 71 are conformed to come into contact with tubular end portions 10, 20 and tubular connection portions 15, 25 of draft 4’, while a central portion of inner space 71 is a second injection chamber 77 configured to surround only inner part 20’ of central portion 20 of draft 4’, once the latter has been arranged into inner space 71 before closing second mould 70. Even in this case, shell elements 75, 76, can be assembled with heads 73 by conventional lock means as screws, for which longitudinal through holes 78,78’ are provided through heads 73 and shell portions 75,76. Even in this case, an injection channel 74 allows a second polymeric material, selected among the above- mentioned materials, to be injected second injection chamber 77. A means of conventional type is also provided for adjusting the temperature of second mould 70, as well as a conventional injection control means, not shown.

[0106] In one embodiment, second injection chamber 77 has a width variable from a minimum value, at a first transversal axis, to a maximum value, at a second transversal axis, in particular first and second transversal axes are perpendicular to each other. This way, at the first transversal axis, the width of second injection chamber 77 is larger than at second transversal axis, and therefore at the first transversal axis, in order to form a variable-thickness elastic constriction shell 40 as shown in Fig. 29A. [0107] In case an endo-urethral valve 4 is made according to the invention in which no elastic constriction shell 40, a similar method can be carried out, not indicated in the figures, but easily understandable by a skilled person. Using the same reference numbers such method provides the following steps forming a draft 4’ of the endo-urethral valve 4, the draft 4’ comprising the proximal tubular portion 10, the distal tubular portion 30 and the central portion 20,

- injection-moulding of a polymeric material in mould 60 comprising an injection chamber 67, in which a longitudinal core member 61 is fixedly arranged to provide the through slit 22; - extracting the longitudinal core member 61 obtaining the closed configuration C of the endo-urethral valve 4.

[0108] The foregoing description of exemplary embodiments of the invention will so fully reveal the invention according to the conceptual point of view, so that others, by applying current knowledge, will be able to modify and/or adapt such embodiments for various applications, without further research and without parting from the invention as defined by the attached claims, and, accordingly, it is meant that such adaptations and modifications will have to be considered as equivalent to the exemplary embodiments and exemplary specific embodiments. The means and the materials to put into practice the different functions described herein could have a different nature without, for this reason, departing from the field of the invention. It is to be understood that the phraseology or terminology that is employed herein is for the purpose of description and not of limitation.