IT202100004631A1 - ENDOURETHRAL VALVE - Google Patents

Description

Description of the industrial invention entitled ?ENDOURETHRAL VALVE?

DESCRIPTION

Scope of the invention

[0001] The present invention relates to an endourethral valve, i.e. an endourethral artificial sphincter, useful for male patients suffering from urinary incontinence.

[0002] More in detail, the invention refers to an endourethral valve configured to be opened elastically by means of a compression exerted by the patient on his own penis at the site of implantation of the endourethral valve, thus to allow the passage of urine through the urethra and the emptying of the bladder, and configured to close again when this compression by the patient ceases.

Prior art

[0003] Various types of endourethral valves are known for treating urinary incontinence. These devices are used when other remedies, such as outpatient therapy, drug therapy and pelvic re-education, fail to resolve the incontinence.

[0004] in particular, US 4,968,294 describes a silicone endourethral valve comprising two cylindrical tubular end portions mutually aligned along a longitudinal axis and a substantially spherical hollow central portion communicating with the two end portions. The central portion contains two sealing lips which extend symmetrically in a plane containing the longitudinal axis from an area of the ball close to the outlet of an end portion of the ball. up to match tightly in the vicinity? of the inlet of the other end portion, at said plane, in a closed non-deformed configuration of the valve. By compressing the bulbous portion perpendicular to this plane, the valve can switch from the closed configuration to an open one in which the sealing lips no longer match?, thus placing? the two end portions communicate with each other.

[0005] US 5,800,339 discloses an endourethral valve similar to the previous one, in which however? the obturator has the shape of a silicone disc comprising a peripheral ring sealedly mounted in the central portion of the valve, and a plurality of of shutter elements in the shape of a circular sector which extend from the ring towards the longitudinal axis and which, in a closed non-deformed configuration of the shutter, are contiguous to each other and offer a seal against the passage of liquid. Also in this case, by compressing the bulb portion at the ring, you can? obtain an open configuration of the valve in which the circular sectors are deformed moving away from the plane of the disk and thus forming? an opening that puts the two end portions in communication with each other.

[0006] US 7,008,372 discloses an endourethral valve comprising a housing in which a first hollow cylindrical portion configured to engage with the inner walls of the urethra ? arranged coaxially and in hydraulic communication with a second cylindrical part, with a smaller diameter than the first, in which ? housed a shutter body. The obturator body comprising a cylindrical assembly portion sealed with the inner surface of the second part of the casing, and a obturation portion provided with a normally closed cross-shaped slot, which can? be opened by compressing the second part of the casing from the outside.

[0007] US 6,022,312 discloses an endosphincter comprising an anchoring part to be fixed in proximity of the natural sphincter, and a hollow cylindrical valve body extending from the attachment part, to be placed inside the urethra. In the valve body? arranged a valve provided with sealing lips which also in this case can be moved elastically from a closed non-deformed configuration to an open deformed configuration by compressing the valve body through the penile tissues. In some embodiments, the opening of the sealing lips is? assisted by a lever mechanism located inside the valve.

[0008] Other endourethral valve devices are described in documents WO 2014/090227 , US 5,954,766 and US 2017/020645 .

Technical Problems

[0009] Endourethral valves of the art have at least one of the disadvantages set out below.

[0010] In the first place, the patient? able to identify the valve body, the cio? the place to compress the device, however pu? have difficulty? to identify the direction according to which it must compress the endourethral valve to obtain its opening: what? occurs in all the devices briefly described above, due to the shape of the outer shell of the valve body.

[0011] Furthermore, many endourethral valves of the known type are constructively complicated, in particular the device described in US 6,022,312, in which the valve body ? intended for installation for almost the entire extension of the urethra, but also the valves according to US 4,968,294 and US 7,008,372, due to the complication of the parts to be molded.

[0012] Some endourethral valves also have the problem of favoring the stagnation of urine after urination, and therefore of the accumulation of possible sediments, in some non-drainable portions of the valve body, as occurs in the devices described in US 4,968,294 and in US 7,008,372.

[0013] ? so felt the need? of an endourethral valve of the type specified at the beginning that solves the aforementioned problems, also taking into account the ease? of implantation and above all of extraction of the endourethral valve from the urethra.

Summary of the invention

[0014] ? therefore, the object of the present invention is to provide an endourethral valve configured to open elastically as a result of a compression exerted by the patient on the penis at the implant site and to close again when the compression ceases, which allows overcoming the aforementioned technical problems.

[0015] in particular, ? object of the present invention is to provide such an endourethral valve which can be easily operated by the patient.

[0016] ? further object of the invention is to provide such an endourethral valve which is simple to manufacture and has a limited production cost.

[0017] ? further object of the invention is to provide such an endourethral valve which is the most? possible draining and avoid the accumulation of sediments inside.

[0018] ? otherwise? object of the invention is to provide such an endourethral valve which is simple to treat by the surgeon, in particular which can be inserted and extracted into/from the urethra simply and without breaking.

[0019] ? It is also an object of the invention to provide a method for manufacturing such an endourethral valve.

[0020] These and other objects are achieved by an endourethral valve as defined in claim 1. Advantageous embodiments of the device are defined in the dependent claims.

[0021] According to the invention, an endourethral valve comprises:

? a proximal tubular portion and a distal tubular portion disposed along a common longitudinal axis and configured to anchor internally to the urethra of a male patient and allow the passage of urine;

? a central portion disposed between the proximal tubular portion and the distal tubular portion and configured to be squeezed by the patient to resiliently transition from a closed undeformed configuration to an open deformed configuration, wherein the central portion respectively seals or hydraulically connects the proximal tubular portion and the distal tubular portion. According to one aspect of the invention, the central portion of the endourethral valve, in the closed undeformed configuration, has a central transverse dimension that varies radially between a maximum central transverse dimension and a minimum central transverse dimension lower than said maximum central transverse dimension.

[0022] In this way the patient ? able to easily identify, by touch, the direction according to which it must exert the compressive forces to cause the opening of the endourethral valve, without having to proceed with multiple and annoying attempts.

[0023] Advantageously, the central portion comprises a solid obturator body provided with a through slot which extends between a proximal side and a distal side of the solid obturator body, i.e. between a side facing the proximal portion and a side facing the distal portion, the through fissure having mutually facing flaps, in which the flaps

? in the closed undeformed configuration, they are in sealing contact with each other along at least a portion of their longitudinal extent;

? are configured to move at a predetermined distance from each other throughout their longitudinal extent as the central portion transitions from the closed undeformed configuration to the open deformed configuration.

[0024] Two non-limiting examples of how to achieve the radial variation of the transversal dimension of the central portion of the endourethral valve are described below.

[0025] For example, in a variant embodiment of the shutter body, an external surface of the central portion has a pair of protuberances in diametrically opposite positions with respect to the longitudinal axis, the protuberances having respective tops at a? predetermined height with respect to an external surface of the central portion, in which the diametrical distance between the tops? gives the maximum central cross-sectional dimension. In particular, these protrusions extend parallel to the longitudinal axis of the endourethral valve to facilitate identification by touch. A minimum practical, non-binding indicative value of the height or protrusion of the protrusions with respect to the external surface of the central portion? about 1mm.

[0026] According to another example, in another embodiment variant of the obturator body, the central portion of the endourethral valve ? a biaxially symmetric central portion with a cross section defined by a figure having a major axis of symmetry and a minor axis of symmetry orthogonal to each other, the major axis of symmetry providing the maximum central transverse dimension. In particular, this cross section ? an ellipse or a figure comparable to an ellipse.

[0027] The shapes of the central section of the endourethral valve according to these variants can be obtained in a relatively simple way through conventional techniques for forming polymeric materials, for example by injection moulding.

[0028] Preferably, the through slot, in the closed undeformed configuration, has a rectilinear cross-section substantially aligned with the maximum central transverse dimension of the central portion of the endourethral valve. In particular, in the two embodiments mentioned above, the cross section of the slot is? substantially aligned, in order, with the diametrically opposed protuberances of the central portion, or ? aligned with the major axis of symmetry of the cross section of the central portion.

[0029] This shape and orientation of the cross section of the slit favors the separation of the edges of the slit and the prompt opening of the endourethral valve under the action of the compression force exerted by the subject on the central portion of the valve through the tissues of his own penis and the wall of the urethra. In fact, the compressive force necessary for this purpose? well defined and easily identifiable as the force that causes the opening of the crack by overcoming a condition of instability? elastic.

[0030] According to another aspect of the invention, the proximal tubular portion and the distal tubular portion have an end transverse dimension of greater than the maximum central transverse dimension.

[0031] In this way, the end portions proximal and distal endourethral valve can easily be stabilized in a certain position within the urethra, in other words the increased size of the end portions proximal and distal contrast the migration of the endourethral valve inside the urethra, for example preventing its expulsion.

[0032] Advantageously, the proximal tubular portion and the distal tubular portion are axisymmetric with respect to the longitudinal axis. In particular, the proximal tubular portion and the distal tubular portion have at least respective outer surfaces having a cylindrical shape. Pi? in particular, the proximal and distal tubular portions comprise respective cylindrical shells.

[0033] A shape of this type? preferable why? allows you to insert and extract easily? such a valve in/from the urethra of a subject.

[0034] Furthermore, such a valve can be accommodated without particular discomfort inside the urethra. Even if the endourethral valve, once implanted, undergoes rotations around its own axis, particularly in the case of a cylindrical shape of the end portions? in contact with the internal wall of the urethra, the advantage would remain of being able to easily identify the direction according to which the compression forces must be exerted to cause the opening of the endourethral valve.

[0035] Advantageously between the proximal tubular portion and/or between the distal tubular portion and the central portion 20? a proximal/distal connecting tubular portion to the central portion is provided, wherein the proximal/distal connecting tubular portion has a cross section that evolves from a centrally symmetrical figure at the axisymmetric proximal tubular portion and/or at the axisymmetric distal tubular portion and said figure having a major axis of symmetry and a minor axis of symmetry at the central biaxialsymmetric portion.

[0036] In a further embodiment of the invention, the edges of the through slot, in the closed undeformed configuration,

? are in sealing contact with each other in a distal part of their longitudinal extension, while ? in a proximal part of their longitudinal extension they have an interspace of decreasing width as they proceed towards the distal part.

[0037] The interspace defined above is regularly filled with urine, so that a gradually increasing pressure is exerted on the proximal parts of the flaps facing it as the bladder fills up with urine. When in the bladder yes ? accumulated a quantity? of urine such that the pressure in the interspace reaches a predetermined critical value, the valve opens releasing the urine. As better described below, in this embodiment the shape of the cavity, the extension of the proximal portion of non-contact between the flaps and the elasticity? of the obturator body of the endourethral valve are chosen so that this critical pressure value is reasonably higher than a nuisance value for which a normal subject would decide to get rid of urine, and lower than a dangerous value for the subject's bladder and urethra . In this way, an endourethral valve with automatic emergency opening controlled by the quantity of water is obtained. of urine present in the bladder. This endourethral valve can be advantageously used for subjects who are unaware and therefore unable to operate the valve autonomously, for example, due to brain damage or as a result of a therapeutic treatment, general anesthesia or similar conditions. What do they avoid? the damages that could arise to the bladder and urethra of the subject in case of exceeding and/or maintaining excessive pressure values inside them. A previously prepared catheter will allow? then advantageously to remove the urine from the subject's body without discomfort for the latter.

[0038] In a further embodiment of the invention, the central portion comprises:

? an internal part made integrally with the proximal and distal portions, e

? an elastic constriction shell arranged around the inner part with a force fit, on an outer surface of the inner part of the central portion, such as to keep the edges of the through slot in contact with each other

in which the elastic constriction shell:

? ? configured to be squeezed externally by the patient so as to move the flaps of the through slot apart from each other and cause the endourethral valve to pass elastically from the closed non-deformed configuration to the open deformed configuration;

? when disposed about the inside of the central portion it has the central cross-section dimension of the central portion varying radially between a maximum central cross-dimension and a minimum central cross-dimension.

In this way it significantly improves the? Reliability? of the valve, since? the closing condition of the valve ? ensured by the compressive forces exerted by the elastic retention shell and ? independent of the operating conditions under which the valve body is formed.

[0039] For example, the elastic constriction shell can be made with a preformed snap ring disposed around the inside of the central portion.

[0040] In a further embodiment of the invention, ? provided is a distal engagement element arranged to be engaged by an endourethral valve positioning and extraction tool, which comprises:

? an endourethral valve anchoring portion incorporated in the distal portion of the endourethral valve, e

? a gripping portion for the positioning and extraction tool comprises:

? .

Thereby ? It is possible to easily extract the endourethral valve from the patient?s urethra, making this operation minimally invasive and significantly reducing the discomfort for the patient.

In particular, the gripping portion protrudes distally from the distal portion of the endourethral valve. There? facilitates the hooking of the distal engagement element by the extractor tool.

[0041] Preferably, the anchoring portion ? incorporated along a peripheral portion of the distal portion of the valve, and the socket portion ? arranged transversely to the endourethral valve between two diametrically opposite zones of the anchoring portion. Advantageously, through holes are made in the anchoring portion. Thus, by making the endourethral valve by injection moulding, the injected polymeric material in the molten state passes through the through holes forming an additional anchorage of the anchoring portion in the mass of the polymeric material, once solidified. There? allows to improve the strength of the connection between the anchoring portion of the distal engagement element and the distal portion of the endourethral valve, making it more the connection between the distal engagement element and the endourethral valve body is strong and prevents the anchoring element from detaching from the valve body and the valve body remaining in the patient's urethra during an extraction manoeuvre.

[0042] The overall maximum transversal dimension of the endourethral valve, in particular the maximum diameter of the valve, net of the maximum transversal dimension of the central portion, ? between 3 mm and 12 mm, preferably between 6 mm and 10 mm. The length of the endourethral valve between 20 mm and 50 mm, especially between 30 mm and 40 mm.

[0043] Advantageously, the endourethral valve ? made of a material selected from a silicone or a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinyl chloride, an ethylene vinyl acetate (EVA) copolymer or a derivative thereof, a thermoplastic elastomer, or a combination of said materials, but preferably ? a silicone. In the embodiment in which ? foreseen the elastic shell of constriction, this pu? be made of a material selected from a silicone or a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinyl chloride, an ethylene-vinyl acetate copolymer (EVA) or a derivative thereof, a thermoplastic elastomer, or a combination of said materials, however the shell constriction elastic ? preferably of the same material as the inside.

[0044] According to another aspect of the invention, the method for manufacturing the endourethral valve described above comprises steps of:

[0045] forming a draft of the endourethral valve, the draft comprising the proximal tubular portion, the distal tubular portion and the inner part of the central portion, by means of a first injection molding operation of a first polymeric material in a first mold comprising a first injection chamber in which ? a longitudinal core is fixed to form the through slot;

[0046] positioning of the draft in a second mold comprising a second injection chamber configured to surround the inner part of the central portion with a sleeve when the draft is ? placed in the second mould;

[0047] forming an elastic constricting shell around the inside of the central portion by a second injection molding operation of a second polymeric material in the second mold, the second injection molding operation being performed such that the elastic shell of constriction forms a force coupling, on an external surface of the internal part of the central portion, such as to keep the edges of the through slot in contact with each other, realizing the closed configuration of the endourethral valve.

Brief description of the drawings

[0048] The invention is illustrated below through the description of some embodiments, made by way of non-limiting example, with reference to the attached drawings, in which:

? figures 1 and 2 schematically show an endourethral valve arranged along the urethra of a subject, respectively in a closed and in an open configuration;

? Figures 3 and 4 are two schematic perspective views of an endourethral valve according to a first embodiment of the invention, in a closed configuration;

? figure 5 ? a side view of the endourethral valve of figures 3 and 4;

? figures 6 and 7 are schematic cross-sectional views of the endourethral valve of figures 3 and 4, according to section planes represented respectively by the lines A-A and B-B of figure 5; ? the figure 8 ? a schematic perspective view of the valve of Figures 3 and 4 in an open configuration;

? figure 9 ? a schematic side view of the endourethral valve in the open configuration of Figure 8 ;

? figures 10 and 11 are schematic cross-sectional views of the endourethral valve in the open configuration of figures 8 and 9, according to section planes represented respectively by the lines A-A and B-B of figure 9;

? figure 12 ? a schematic perspective view of an endourethral valve according to a second embodiment of the invention;

? figures 13 and 14 are two schematic side views of the endourethral valve of figure 12 according to lines of sight orthogonal to each other;

? figures 15, 16 and 17 are schematic cross-sectional views of the endourethral valve of figure 12, according to section planes represented respectively by the lines C-C, D-D, E-E of figure 14;

? Figures 18, 19 and 20 are schematic perspective and side views of the endourethral valve of Figures 12-17, in which the valve ? in an open configuration;

? figures 21, 22 and 23 are schematic cross-sectional views of the endourethral valve of figure 12, in the open configuration of figures 19 and 20, according to section planes represented respectively by the lines C-C, D-D, E-E of figure 20;

? figures 24 and 25 are schematic cross-sectional views of the endourethral valve of figure 12 , in which the enlargement of figure 25 shows the action of the pressure forces of the urine contained in the proximal portion of the endourethral valve in the closed configuration;

? figures 26 and 27 are schematic cross-sectional views of an endourethral valve in accordance with a third embodiment of the invention in which the enlargement of figure 27 shows the action of the pressure forces of the urine contained in the proximal portion of the valve endourethral in the closed configuration;

? figure 28 ? a schematic longitudinal sectional view of an endourethral valve according to a fourth embodiment of the invention, according to a sectional plane passing through the median longitudinal axis, in a closed configuration of the valve; ? Figures 29A and 29B are schematic cross-sectional views of the central portion of the valve of figure 28, according to two variants;

? figure 30 ? a schematic longitudinal sectional view of the body of the valve of figure 28 , without the external constriction shell;

? Figures 31A and 31B are schematic cross-sectional views of the central portion of the body of the valve of figure 29, according to the two variants of figures 29A and 29B;

? Figures 32 and 33 are respectively side and bottom schematic views of an endourethral valve in accordance with a fifth embodiment of the invention, in which ? provided a distal engagement member arranged to be engaged by an endourethral valve placement and extraction tool from the urethra;

? figure 34 ? an isometric view of the distal engagement member of Figures 32 and 33;

? Figures 35 and 36 are schematic perspective views of molds which can be used to make an endourethral valve according to the invention.

Description of preferred embodiments

[0049] Figures 1 and 2 schematically show an endourethral valve 6 arranged inside the urethra 8 of a male patient. The endourethral valve 6 ? shown in a closed configuration C (figure 1), in which the endourethral valve 6 prevents the passage through the urethra 8 of urine 90 contained in the bladder 8? of the patient, and in an open configuration O (figure 2) in which the endourethral valve 6 allows this passage.

[0050] The endourethral valve 6 ? configured to open due to the effect of a compression force F exerted by the patient on his own penis 7 in correspondence with the implant site and, through the tissues of the penis 7, on the urethra 8 and on the endourethral valve 6, and also configured to close elastically when the compressive force F ceases.

[0051] Figures 3-32 show endourethral valves 1,2,3,4,5 in accordance with different embodiments of the invention. The urethral valve according to the invention comprises tubular end portions proximal 10 and distal 30 arranged along a common longitudinal axis 9 and configured to anchor internally to the urethra 8 (figures 1,2), and furthermore comprises a central portion 20 between the tubular end portions 10 and 30. The central portion 20 ? an obturator portion configured in such a way that, upon receiving the compressive force F exerted by the patient, it is compressed passing elastically from the closed non-deformed configuration C to the open deformed configuration O. In the closed configuration C the central portion 20 separates the portion in a liquid-tight manner proximal tubular portion 10 from the distal tubular portion 30, while in the open deformed configuration O the central portion 20 hydraulically connects the proximal tubular portion 10 to the distal tubular portion 30.

[0052] As shown in figures 6, 15, 29A, according to the invention, as shown in figures 6, 15, 29A, the central portion 20 of the endourethral valves 1,2,3,4,5 has a transversal dimension which, in the closed undeformed configuration C, it varies radially between a maximum value D2 and a minimum value D1.

[0053] As shown in figures 3, 5, 8, 10, 12, 15, 18, 21, 24, 26, 29A-B, 31A-B, the central portion 20 comprises a solid shutter body 21 provided with a through slot 22 which extends between a proximal side 19 and a distal side 29 of the solid obturator body 21, i.e. between a face 19 facing the proximal portion 10 and a face 29 of the shutter body 21 facing the distal portion 30. The through slot 22 ? defined by at least a pair of mutually facing flaps 23 which in the closed non-deformed configuration C, are in sealing contact with each other (figures 3, 5, 12, 15, 24, 26, 29A-B, 31A-B), and which they are also configured to move to a predetermined distance from each other along their entire longitudinal extension when the central portion 20 passes from the closed undeformed configuration C to the open deformed configuration O (figures 8, 10, 18, 21).

[0054] The variability? of the external transverse dimension or of the external diameter of the central portion 20 pu? be accomplished in various ways. In particular, as figures 3-6 show, in an endourethral valve 1 in accordance with a first embodiment of the invention, the outer surface of the central portion 20 has a pair of protuberances 24 in diametrically opposite positions with respect to each other and with respect to the central portion 20. longitudinal axis 9 of the endourethral valve 1. The protuberances 24 emerge from the external surface with their tops? 24? for a predetermined height H, preferably greater than or at least equal to 1 mm. Therefore, as shown in figure 6, the central portion 20 has a transversal dimension which varies from a minimum value D1, in correspondence with the diameters distant from the protuberances 24, to a maximum value D2 = D1 2H, in correspondence with the diameter passing through the tops ? 24? of the protuberances 24. Preferably, the protrusions 24 extend parallel to the longitudinal axis 9.

[0055] The through slot 22 can have cross-sections of various shapes and positions/orientations. Advantageously, in the closed undeformed configuration C, this cross section is? however rectilinear and preferably, as shown in figures 6, 15, 29A-B, ? substantially aligned with the maximum transverse dimension of the central portion 20. In particular, the cross section of the slot 22 is aligned with the diametrically opposed protuberances 24 of the outer surface of the central portion 20.

[0056] Preferably, moreover, the tubular end portions proximal and distal 10,30 are axisymmetric with respect to the longitudinal axis 9, in particular the tubular end portions 10,30 have a cylindrical shape at least externally, as shown for example in figures 3, 4, 12, 32, or also internally.

[0057] As shown for example in Figure 13, in an advantageous embodiment, the proximal and distal tubular portions 10, 30 have a transverse end dimension T, in particular a diameter T, greater than the maximum central transverse dimension D2 of the central portion.

[0058] As shown in figures 15, 29A and 31, the central portion 20 can be a biaxiallysymmetric body, that is? a body which has a biaxially symmetrical shape 16 as its cross section. In other words, as indicated in figure 15, the cross section of the central portion 20 is a figure that has a major axis of symmetry 26? and an axis of minor symmetry 26?, in particular orthogonal to each other. In this case, the slot 22 preferably has a rectilinear cross section aligned with the major axis of symmetry 26?. For example, the cross section of the central potion 20 can? be elliptical or similar in shape to an ellipse, other than the radius of curvature in limited portions of the section.

[0059] Preferably, in the case of tubular end sections? 10, 30 with transverse dimensions greater than the central portion 20, or with a cross-sectional shape different from the biaxialsymmetric one of the central portion 20, the endourethral valve 2 comprises a tubular proximal/distal connecting portion 15, 25 between the central portion 20 and the proximal tubular portion 10 and/or the distal tubular portion 30, as shown for example in figures 13, 14, 26, 28. In this case, as indicated in figures 15-17, if the end tubular portions? 10, 30 have cylindrical symmetry, the cross section of the connecting tubular portion 15,25 gradually transforms from a centrally symmetrical figure 17 into the biaxiallysymmetrical figure 16 going from the proximal and/or distal tubular portion 10,30 to the central portion 20.

[0060] In an endourethral valve 3 in accordance with a third embodiment, shown in longitudinal section in figures 26 and 27, the edges 23 of the through slot 22, in the closed undeformed configuration C, are in sealing contact with each other only in one distal part 27? of its longitudinal extension, while in a proximal part 27? of their own longitudinal extension they form a gap 28 of width S which decreases as it proceeds towards the distal part 27? of the through slot 22. The enlarged section of figure 27 schematically shows the pressure forces P that the urine 90 exerts on the internal walls of the proximal part of the valve and on the edges 23 of the slot 22. These pressure forces P are directed so as to move the flaps away from each other 23. When in the bladder 8? does it accumulate a quantity? of urine 90 such that the pressure in the interspace 28 reaches a predetermined critical value, for which the results of the pressure forces P which are exerted on the two flaps 23 exceed the elastic forces exerted by the material of the obturator body 21 which instead tend to bring the flaps 23, the flaps 23 detach along their entire longitudinal extension 27?,27? bringing the endourethral valve 3 to the open configuration and releasing the urine.

[0061] For comparison, figure 25 schematically shows the pressure forces P which are exerted only on the internal walls of the proximal part of the endourethral valve 2, but not on the edges 23 of the slit in an endourethral valve such as the endourethral valve 2 of figures 13 and 14, in which the edges 23 of the through slot 22, in the closed undeformed configuration C, are in sealing contact with each other along their entire longitudinal extension. In the endourethral valve 2 of figure 25, the resultant of the pressure forces P has a much smaller transversal component than in the case of the endourethral valve 3 of figures 26 and 27. Therefore, in this case, even a very high urine pressure value 9 the pressure forces P alone are not able not ? capable of equalizing the elastic closing forces and causing the mutual detachment of the edges 23 of the slit 22 and, therefore, the opening of the endourethral valve 2.

[0062] The shape of the gap 28 and the extension 27? of the proximal part of the slot 22, in relation to the characteristics of elasticity? of the material of the obturator body 21, are chosen so that the critical pressure value mentioned above is reasonably higher than a nuisance value for which a normal subject would decide to get rid of urine 90, but lower than a pressure value such as to damage the bladder 8? and the subject's urethra 8. In summary, does the endourethral valve 3 open automatically when this critical pressure value is reached, preventing excessive pressure from damaging the bladder 8? and the urethra 8 of the subject, in particular, of a subject who is unaware and therefore unable to maneuver the endourethral valve 3 autonomously, for example, due to brain damage or as a result of a therapeutic treatment or general anesthesia . Advantageously, a catheter, not shown, is arranged to allow urine to be removed from the body of the subject without discomfort for the latter.

[0063] With reference to figures 28-31B, an endourethral valve 4 is described in accordance with a fourth embodiment of the invention. The endourethral valve 4 ? made in two parts, includes what? a draft 4? and an elastic constriction shell 40 to keep the slit 22 and therefore the valve 4 in the closed configuration C, as shown in figure 29. More? precisely, the central portion 20 of the valve 4 comprises an internal part 20? made entirely with the portions of extremity? proximal 10 and distal 30, as well as? in this case with the proximal 15 and distal 25 connecting portions, and the elastic constriction shell 40 ? arranged around the inside 20? forming with it a force coupling such as to keep the edges 23 of the through slot 22 in mutual contact. In draft 42, in general, the edges 23 of the slit 40 may not be in contact with each other.

[0064] The elastic constriction shell 40 ? configured to be squeezed externally by the patient so as to distance the edges 23 of the through slot 22 from each other and to make the endourethral valve 4 pass elastically from the closed non-deformed configuration C to the open deformed configuration O, not shown but easily understood, for example, from figures 20 and 21.

[0065] When the elastic constriction shell 40 ? arranged around the inside 20? of the central portion 20, has its central transverse dimension varying radially between the maximum central transverse dimension D2 and a minimum central transverse dimension D1. There? can? be obtained as shown in figure 29A, ie? realizing an elastic constriction shell 40 which has this characteristic, in other words realizing an elastic constriction shell 40 of variable thickness, while the internal part 20? of the central portion 20 pu? have a cylindrical shape, as shown in Figure 31A. Alternatively, as shown in FIGS. 29B-31B, ? Is it possible to make the internal part 20? with a transversal shape of variable diameter as indicated above, for example with an elliptical shape, and an elastic constriction shell 40 for example of constant thickness, so that, due to the force coupling with the internal part 20?, the shell elastic constriction 40 deforms giving the required variability? of the transverse dimension to the central portion 20 cos? obtained.

[0066] In any case, the elastic constriction shell 40 can be made as a preformed elastic ring of predetermined internal dimensions and predetermined elasticity, which is then disposed around the internal part 20? by force coupling.

[0067] Figures 32 and 33 show an endourethral valve 5 in accordance with a fifth embodiment of the invention, in which ? a distal engagement element 50 is provided for an extractor tool, not shown, so as to facilitate the positioning and above all the extraction of the endourethral valve 5 from the patient?s urethra 8 (figures 1,2), for example to replace the endourethral valve 5. The distal engagement element preferably comprises, in addition to a gripping portion 52 configured to engage with a positioning and extraction tool, not shown, an anchoring portion 51 incorporated or in any case integral with the distal portion 30 of the endourethral valve 5. The incorporation can be performed by arranging the distal engagement element in a mold for manufacturing the endourethral valve 5 by injection moulding, as described below. after you. In such a case, the distal engagement element 50 can? be made of a different material from the rest of the endourethral valve 5, for example a metallic or ceramic material, or a plastic material with a higher softening point than the material with which it is made. endourethral valve formed 5.

[0068] Alternatively, the distal engagement element 50 can be made of the same material with which ? the endourethral valve 5 is formed, if strong enough, during injection moulding, using a suitably shaped mould, not shown.

[0069] As figure 33 shows, the gripping portion 52 is preferably arranged transversely, that is? between two diametrically opposite areas of the anchoring portion 51, in this case along a diameter of the distal portion 30 of the endourethral valve 5, and ? preferably protruding from the distal portion 30, while the anchoring portion 51 is perimetrically incorporated in the distal portion 30.

[0070] Figure 34 shows an embodiment of the distal engagement element 50, in which through holes are made in the anchoring portion 51, which has a substantially cylindrical shape and is suitable for incorporation into a distal portion 30 which is also substantially cylindrical 55 to facilitate the anchoring of the anchoring portion 51 to the distal portion 30.

[0071] The endourethral valve according to the various embodiments of the invention, including those shown in the drawings, preferably has an overall maximum transverse dimension K (figures 5, 13 and 14), net of the maximum central transversal dimension D2, in particular a maximum diameter K, ? between 3 mm and 12 mm, in particular between 6 mm and 10 mm.

[0072] Furthermore, the endourethral valve according to the various embodiments of the invention preferably has a length L (figures 5, 13 and 14) comprised between 20 mm and 50 mm, in particular between 30 mm and 40 mm.

[0073] The endourethral valve ? made of a biocompatible material. This material can be selected from a silicone or a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinyl chloride, an ethylene-vinyl acetate copolymer (EVA) or a derivative thereof, a thermoplastic elastomer, or a combination of said materials, but preferably ? a silicone.

[0074] In particular, in the case of the two-part endourethral valve 4 in accordance with the fourth embodiment, the elastic constriction shell 40? made of a material selected from a silicone or a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinyl chloride, a thermoplastic elastomer, or a combination of said materials, but preferably of a silicone.

[0075] The elastic constriction shell 40 can? be made of the same material as the inside 20? of the central portion 20 of draft 4?.

[0076] In some embodiments not shown, the proximal portion of the endourethral valve can further comprising a tubular extension or a stent of known type configured to be fixed in the bladder, at the mouth of the urethra. The tubular extension can? be made in one piece with the remainder of the urethral valve, or in a separate piece to be applied after forming, in which case the proximal portion of the urethral valve, on one side, and the extension, or stent, on the other , are provided with respective reciprocal connection means, preferably snap or interlocking.

[0077] The endourethral valve can? be made through a process comprising injection molding steps as described, with reference to figures 35 and 36.

[0078] In fact, part of the present patent application also includes a method for manufacturing the endourethral valve according to the invention, in accordance with the various embodiments and others which can be deduced from the present description.

[0079] The method can be used to make both an endourethral valve in one piece, i.e. made of a single material, for example the endourethral valve 2 of figures 3-8, and an endourethral valve in two pieces, i.e. in which the draft 4? and elastic constriction shell 40 are made of two distinct materials.

[0080] Does the method in fact provide for a first phase of forming a draft 4? by moulding, in particular injection moulding. As anticipated, draft 4? comprises the proximal tubular portion 10, the distal tubular portion 30 and an inner part 20? of the central portion 20. The first phase of forming the draft 4? is performed by means of an injection molding process of a first biocompatible polymeric material, selected from a silicone or a polysiloxane, in particular polydimethyl siloxane, a polyurethane, polyvinyl chloride, a thermoplastic elastomer, or a combination of said materials, preferably a silicone, in a first mold 60 shown in figure 35.

[0081] The first mold 60 comprises two heads 62 and 63 and a pair of shell portions 66 which define a first injection chamber 67 having, for example, a shape congruent with the shape of the valve 2, or other embodiments of the endourethral valve , including those shown here. The mold can be closed using conventional tightening means such as screws, for which through holes 68 are provided longitudinally in the heads 62 and 63, and corresponding threaded holes 68? made longitudinally in the shell portions 66. From a central position of the heads 62 and 63, respective support elements 65 extend towards the inside of the mold 60 for a longitudinal core 61 arranged longitudinally in the first injection chamber 67, to form the slot 22. An injection channel 64 allows to inject the polymeric material indicated above into the first injection chamber 67. conventional and not shown thermostating means of the mold 60 are provided, as well as? means for controlling the injection molding operation, also of a known type and not shown.

[0082] The mold 60 (figure 35) can be used to form an endourethral valve such as the valve 2 when made with a preformed elastic ring disposed around the internal part 20? of the central portion 20 of the valve, in which case ? only one step of injection molding is foreseen.

[0083] In the case of valves 2, 4 in two materials, or in two pieces of the same material, draft 4? is removed from the first mold 60 and positioned in a second mold 70, shown in figure 36, to perform a step of forming the elastic constriction shell 40 and completing the endourethral valve 1,2,3,4,5,6 by injection of a second polymeric material into the second mold 70.

[0084] The second mold 70 also comprises two heads, of which for clarity ? represented a single head 73, which defines an internal space 71 whose end portions? are they shaped to come into contact with the tubular end portions? 10,20 and connection 15,25 of the draft 4?, while the central portion of the internal space 71 constitutes a second injection chamber 77 configured to encircle only the central portion of the draft 4?, i.e. the inside 20? of the formanda central portion 20, when the draft 4? ? arranged in the second closed mold 70. For this purpose, are the shell elements 75 and 76 suitably shaped, which can also in this case be assembled to the heads 73 using conventional tightening means such as screws, for which the through holes 78 are provided longitudinally through the heads and 78? through the shell portions 75, 76. An injection channel 44 allows to inject the second polymeric material, which is chosen among those indicated above, in the second injection chamber 77, but which can? also be the same as the first material of the first stage of injection molding. Also in this case, thermostatic means are provided for the mold 70, as well as? means for controlling the injection molding operation, such means being of a known type and not shown.

[0085] The second injection chamber 77 ? made with a width varying from a minimum value, in correspondence with a first transversal axis, to a maximum value, in correspondence with a second transversal axis, in particular, perpendicular to the first transversal axis, so that the internal part 20? of the central portion 20 is deformed to a greater extent in correspondence with the first transverse axis, where the width of the second injection chamber 77 ? greater and is deformed to a lesser extent, in correspondence with the second transverse axis, where the width of the second injection chamber 77 is? minor.

[0086] The above description of embodiments and variations of the invention ? able to show the invention from a conceptual point of view so that others, using the prior art, will be able to modify and/or adapt these specific embodiments in various applications without further research and without departing from the inventive concept, and, therefore, intends that such adaptations and modifications will be considered as equivalent to the specific variants and embodiments. The means and materials for achieving the various functions described may be of various kinds without thereby departing from the scope of the invention. It is understood that the expressions or terminology used are for purely descriptive purposes and, therefore, not limiting.

Claims (10)

1. An endourethral valve (1,2,3,4,5,6) comprising: ? a proximal tubular portion (10) and a distal tubular portion (30) arranged along a common longitudinal axis (9) and configured to anchor internally to the urethra (8) of a male patient and allow the passage of urine (90) ; ? a central portion (20) arranged between said proximal tubular portion (10) and said distal tubular portion (30) and configured to be squeezed by said patient so as to move elastically from a closed non-deformed configuration (C) to an open deformed configuration (O), wherein said central portion (20) respectively seals or hydraulically connects said proximal tubular portion (10) and said distal tubular portion (30), characterized in that said central portion (20), in said configuration does not deformed closed (C), has a central transversal dimension that varies radially between a maximum central transversal dimension (D2) and a minimum central transversal dimension (D1) lower than said maximum central transversal dimension (D2), so that said patient can easily identify the direction in which to exert a compressive force to crush said central portion (20) and cause the opening of the endourethral valve. 2. The endourethral valve (1,2,3,4,5) according to claim 1, wherein said central portion (20) comprises a full obturator body (21) provided with a through slot (22) which extends between a proximal side (19) and a distal side (29) of said solid obturator body (21), said through slot (22) having flaps (23) facing each other, in which said flaps (23) ? in said closed undeformed configuration (C), they are in sealing contact with each other along at least one part (27?) of their own longitudinal extension; ? they are configured to move to a predetermined distance from each other for their entire longitudinal extension when said central portion (20) passes from said closed non-deformed configuration (C) to said open deformed configuration (O). The endourethral valve (1) according to claim 1, wherein said central portion (20) is choice between: ? a central portion with a pair of protuberances (24) in diametrically opposite positions with respect to said longitudinal axis (9), said protuberances (24) having respective tops? (24?) at a predetermined height (H) with respect to an external surface of said central portion (20), the diametrical distance between said tops? (24?) providing said maximum central transversal dimension (D2), in particular, said protrusions extend parallel to said longitudinal axis (9); ? a bisalsymmetric central portion (20) with a cross section defined by a figure (18) having a major symmetry axis (26?) and a minor symmetry axis (26?) orthogonal to each other, said major symmetry axis (26? ) providing said maximum central transversal dimension (D2), in particular, said central potion (20) has an elliptical cross section or similar to an ellipse. 4. The endourethral valve (1) according to claims 2 or 3, wherein said through slot (22), in said closed undeformed configuration (C), has a rectilinear cross section substantially aligned with said maximum central transverse dimension (D2), in particular aligned with said diametrically opposite protuberances (24) or aligned with said major symmetry axis (26?) of said cross section of said central portion (20). 5. The endourethral valve (2,3,4,5) according to claim 1, wherein said proximal tubular portion (10) and said distal tubular portion (30) have a transverse end dimension? (T) greater than said maximum central transversal dimension (D2). in particular, said proximal tubular portion (10) and said distal tubular portion (30) have an axisymmetric shape, with respect to said longitudinal axis, more? in particular they have a cylindrical shape. 6. The endourethral valve (3) according to claim 2, wherein said flaps (23) of said through slot (22), in said closed undeformed configuration (C), ? are in sealing contact with each other at a distal portion (27?) of their longitudinal extent, while ? in a proximal part (27?) of their own longitudinal extension they have an interspace (28) of width (S) which decreases as they proceed towards said distal part (27?). 7. The endourethral valve (4) according to claim 2, wherein said central portion (20) comprises: ? an internal part (20?) made integrally with said proximal tubular portion (10) and with said distal tubular portion (30), and ? an elastic constriction shell (40) arranged around said internal part (20?) with a force coupling on an external surface of said internal part (20?) such as to maintain said flaps (23) of said through slot (22) , inside said internal part (20?), in contact with each other, wherein said elastic constriction shell (40): ? ? configured to be squeezed externally by said patient so as to distance said flaps (23) of said through slot (22) from each other and make said endourethral valve (4) pass elastically from said closed non-deformed configuration (C) to said open deformed configuration (OR); ? when arranged around said inner part (20?) of said central portion (20), it has said central transverse dimension of said central portion (20) varying radially between said maximum central transverse dimension (D2) and said minimum central transverse dimension (D1 ). The endourethral valve (5) according to claim 1, comprising a distal engaging member (50) arranged to be engaged by a placement and extraction tool of said endourethral valve (5), wherein said distal engaging member (50 ) comprehends: ? an anchoring portion (51) incorporated in said distal tubular portion (30) of said endourethral valve (5), and ? a gripping portion (52) for said positioning and extraction tool, in particular, said gripping portion (52) protrudes distally from said distal tubular portion (30) of said endourethral valve (5), in particular, said anchoring portion (51) ? perimetrically incorporated to said distal tubular portion (30), and said gripping portion (52) ? arranged transversely to said endourethral valve (5) between two diametrically opposite areas of said anchoring portion (51), in particular, through holes (55) are made in said anchoring portion (51) to favor the anchoring of said distal tubular portion (30) to said endourethral valve (5). 9. The endourethral valve according to claim 1, wherein said endourethral valve is made of a material chosen from: ? a silicone or a polysiloxane, in particular polydimethyl siloxane; ? a polyurethane; ? polyvinyl chloride; ? an ethylene-vinyl acetate copolymer or a derivative thereof; ? a thermoplastic elastomer; ? a combination of the above. 10. A method of manufacturing an endourethral valve (4) comprising: ? a proximal tubular portion (10) and a distal tubular portion (30) arranged along a common longitudinal axis (9) and configured to anchor internally to the urethra (8) of a male patient and allow the passage of urine (90) ; ? a central portion (20) disposed between said proximal tubular portion (10) and said distal tubular portion (30), wherein said central portion (20) comprises: ? an internal part (20?) made integrally with said proximal tubular portion (10) and with said distal tubular portion (30), wherein said internal part (20?) comprises a full obturator body (21) provided with a through slot (22) which extends between a proximal side and a distal side of said full obturator body (21), said through slot (22 ) having flaps (23) facing each other; ? an elastic constriction shell (40) arranged around said internal part (20?) with a force coupling on an external surface of said internal part (20?) such as to maintain said flaps (23) of said through slot (22) in contact with each other, wherein said central portion (20) ? configured to be squeezed by said patient so as to pass elastically ? from a closed non-deformed configuration (C), in which said flaps (23) a are in sealing contact with each other along at least one part (27?) of their longitudinal extension, ? to an open deformed configuration (O), in which said flaps (23) are at a predetermined distance from each other for their entire extension, wherein said central portion (20) has a central transverse dimension that varies radially between a maximum central transverse dimension (D2) and a minimum central transverse dimension (D1), said method comprising the phases of: ? forming a draft (4?) of said endourethral valve (4), said draft (4?) comprising said proximal tubular portion (10), said distal tubular portion (30) and said internal part (20?) of said central portion (20), by means of a first injection molding operation of a first polymeric material in a first mold (60) comprising a first injection chamber (67) in which ? a longitudinal core (61) is fixed to form said through slot (22); ? positioning of said draft (4?) in a second mold (70) comprising a second injection chamber (71) configured to encircle said internal part (20?) of said central portion (20) when said draft (4?) ? arranged in said second mold (70); ? forming an elastic constriction shell (40) around said inner part (20?) of said central portion (20) by a second injection molding operation of a second polymeric material in said second mold (70), said second operation of injection molding being performed in such a way that said elastic constriction shell (40) forms a force coupling, on an external surface of said internal part (20?) of said central portion (20), such as to maintain said flaps ( 23) of said through slot (22) in contact with each other realizing said closed configuration (C) of said endourethral valve (4).