Intraurethral prosthesis with valve and kit for intraurethral prosthesis

Abstract

The kit for the intraurethral prosthesis comprises a proximal (2) and distal (4) having a proximal and distal tubular portion (24, 46) respectively configured to be placed inside the patient's urethra (7), and a proximal stent and distal stent (21, 49) respectively configured to be fixed internally in the urethral-vesicle lumen and urethra, wherein the proximal and distal tubular portions (24, 46) have a predetermined radial rigidity and have proximal and distal connecting ends (29, 31) on opposite sides of the proximal and distal stents (21, 49) configured to form a longitudinal duct (5) that is liquid-tightly connected to each other to transport urine. In an advantageous embodiment, the distal tubular portion or proximal tubular portion (46, 24) is divided into a first distal tubular element or proximal tubular element (35, 25) having a distal connecting end or proximal connecting end (31, 29), and a second distal tubular element or proximal tubular element (45, 34), the first distal tubular element or proximal tubular element (35, 25) and the second distal tubular element (45) or proximal tubular element (45, 34) each having mutually liquid-tight connecting ends (37, 44), and the second distal tubular element or proximal tubular element (45, 25) preferably forms an axially flexible intermediate portion (3) of the prosthesis. In this way, prostheses suitable for many anatomical deformities can be obtained by selecting the length of a single, preferably intermediate, portion within the proximal tubular portion and / or distal tubular portion (24, 46), and at least one valve element (50, 150, 250) is open to the differential pressure (P * The valve elements (50, 150, 250) are configured to elastically deform from a static closed configuration to a forced open configuration when the pressure exceeds a certain value, thereby allowing the valve elements (50, 150, 250) to open as the intraperitoneal pressure increases. In particular, the stopper elements (156, 256) of the improved valve elements (155, 250) include elastic walls (155, 255) separated by through slits (157, 257) that converge to the same convergence point (158, 258) shifted from the outer circumference of the stopper elements by a distance (6) of at least 0.02 mm from the center point of the valve elements (150, 250).

Description

[Technical Field]

[0001] The present invention relates to an intraurethral device for treating urethral stenosis in men due to benign prostatic hyperplasia and / or urinary incontinence in male and female subjects. [Background technology]

[0002] As is known, in some cases, benign prostatic hyperplasia (BPH) causes narrowing of the longer or shorter portion of the urethra closer to the bladder, making it difficult to empty the bladder. Urination involves a first sphincter known as the internal urethral sphincter, located just outside the bladder outlet, and a second sphincter known as the external urethral sphincter, located further downstream. In male subjects, the prostate is also known to be located between the two sphincters. The external urethral sphincter is composed of striated muscle, and its control is voluntary to prevent / enable urination. Generally, subjects with BPH retain the function of the external sphincter and, as a result, do not suffer from single incontinence.

[0003] Urinary incontinence is also known to occur in both men and women who are unable to adequately or completely control the external urethral sphincter. To treat these conditions, there are various artificial sphincters that are used when other treatments such as outpatient therapy, drug therapy, and pelvic re-education are ineffective. Some artificial sphincters are enclosed in a tubular casing of a length allocated for insertion into the urethra, and inside are arranged one or more valve assemblies of various types, as described, for example, in International Publication No. 2013144770.

[0004] However, well-known types of artificial sphincters have several drawbacks. In particular, these devices cannot be easily adapted to the anatomical changes of individual patients, as described below. In other words, the tubular casings of such devices do not always fit the anatomical features associated with conditions such as urinary incontinence and / or benign prostatic hyperplasia.

[0005] The first case concerns a female incontinence patient with a short urethral tract, who therefore requires a minimally invasive device.

[0006] The second case concerns a male patient who, in addition to suffering from urinary incontinence, also has a problem of benign prostatic hyperplasia, which involves narrowing of the longer or shorter portion of the urethra, depending on the size of the individual patient's prostate.

[0007] A third important case concerns male patients suffering from urinary incontinence as a result of surgery involving a reduction in urethral length after prostatectomy. In this case, it is important to adapt the device to the new urethral length to avoid pain or other discomfort that the patient may experience during daily activities. For example, a device that is too long may be perceived when the patient is seated. On the other hand, a device that is too short may result in lateral leakage of urine and / or movement of the device itself.

[0008] It is known that intraurethral devices use valve assemblies that include elastic walls arranged radially and separated from each other by through-slits converging towards the center of the device, wherein the elastic walls are configured to switch from a dormant closed configuration to a forced open configuration when the urine pressure acting on the elastic wall exceeds a predetermined open pressure, and to elastically return to the dormant closed configuration when the urine pressure is released.

[0009] Such valve assemblies are described, for example, in the cited International Publication No. 2013144770 and are particularly inexpensive and easy to manufacture. However, in such assemblies, incomplete opening and closing (the latter resulting in suboptimal airtightness) can occasionally occur. More specifically, incomplete opening of the valve due to intravesical pressure can result in the formation of an excessively small open lumen, which makes it difficult to quickly drain urine. Furthermore, in some cases, the elastic walls may stick together at the moment of re-closure, resulting in urine being unconsciously lost later through the lumen remaining at the ends of the elastic walls.

[0010] To mitigate this problem, devices have been proposed in which two such valve assemblies are arranged in series, or a safe slidable plunger magnetically actuated from outside the patient's body has been introduced to maintain the elastic wall in a closed configuration (see WO 2013 / 144770). However, such leak prevention measures complicate the structure and operation of the device and further increase the cost of the device.

[0011] The problem of an intraurethral device that a surgeon can adapt in length according to the actual needs of the surgery is disclosed in WO 2020 / 089623 (A2). In particular, a tubular portion with a maximum length is provided, so that the surgeon can excise the excess tubular portion to adapt the device to the actual length of the patient's urethra.

[0012] WO 2022 / 180620 (A1) discloses a short intraurethral device adapted only for male patients. Its length cannot be changed by the surgeon. The proximal tubular end of the intraurethral device can be connected to a tubular extension terminating in a stent configured to be fixed within the bladder. Snap-fit or positive engagement means of interconnection between the intraurethral device and the tubular extension are disclosed. SUMMARY OF THE INVENTION

[0013] Therefore, an object of the present invention is to provide an intraurethral device that can take into account the degree of stenosis and prevent stenosis of the urethra in male patients with prostate hyperplasia while maintaining the function of the external urethral sphincter.

[0014] Another object of the present invention is to provide an intraurethral device having an artificial sphincter function that enables anatomical changes in patients with urinary incontinence.

[0015] A specific object of the present invention is to provide an intraurethral device having the function of an artificial sphincter that can be used in both male and female patients, ensuring minimal invasiveness in the latter case considering the short length of the urethral tube.

[0016] Another specific object of the present invention is to provide an intraurethral device having an artificial sphincter function that can be used in male patients, and in particular, in patients with urinary incontinence after prostatectomy, to take into account possible anatomical changes in order to avoid the above-mentioned discomfort.

[0017] Another object of the present invention is to provide an intraurethral prosthesis that can be curved along the urethra, thereby minimizing the stress exerted by the prosthesis on the urethra, as well as the accompanying pain and harmful tissue reactions that may result from implantation.

[0018] A further object of the present invention is to provide an intraurethral device provided with a valve assembly of the type described in the introduction, without the above-mentioned problem of incomplete opening and closing.

[0019] According to one aspect of the present invention, these objects and other objects are achieved by a kit for an intraurethral prosthesis comprising a proximal part and a distal part for the intraurethral prosthesis according to claim 1. Advantageous embodiments of the kit are defined in the dependent claims.

[0020] The proximal part of the kit - a proximal tubular portion configured to be disposed within the patient's urethra, and - a proximal stent configured to be reversibly fixed to the inner wall of the urethra - bladder lumen, The distal part of the kit - a distal tubular portion configured to be disposed within the urethra, and - a distal stent configured to be reversibly fixed to the inner wall of the urethra, The proximal tubular portion and the distal tubular portion have a predetermined radial rigidity, The proximal tubular portion and the distal tubular portion are each liquid - tightly connected to each other on the opposite sides of the proximal stent and the distal stent, thereby having proximal connection ends and distal connection ends configured to connect the proximal part and the distal part, thereby defining a single longitudinal duct arranged to convey urine, formed by the proximal tubular portion and the distal tubular portion. Either the proximal or distal portion is a single portion of a predetermined length, while the other portion, either distal or proximal, is provided as a range of two or more portions of different lengths, each configured to be selectively assembled with the proximal or distal portion provided as a single specimen of a predetermined length, thereby producing two or more full-length intraurethral prostheses to select the one best suited to the patient's urethra.

[0021] In this way, it is possible to fabricate urethral prostheses in multiple lengths, and as a result, it is possible to adapt to the patient's highly variable anatomical features by fabricating only a portion of the urethral prosthesis, especially the distal portion, in several lengths, while providing other portions, especially the proximal portion which is more complex and expensive to manufacture, in a single length.

[0022] In one form of use, the system is an assembly kit delivered to the surgeon, comprising either a proximal or distal portion in a single specimen of assigned length, and either the distal or proximal portion in multiple specimens of different lengths, which the surgeon assembles by removing the components from the kit at the time of implantation to create an intraurethral prosthesis of appropriate length to the patient's anatomical features.

[0023] Alternatively, after the surgeon assesses the length of the patient's urethra and other anatomical parameters, a prosthesis of the appropriate length for each individual patient can be ordered and delivered by the manufacturer or distributor, already assembled and preferably sterile.

[0024] In any case, whenever the term "kit" is used herein in reference to the possibility of assembling various parts during use or preparation for use, it is clear that the advantages of the present invention also exist in the manufacturing process, as prostheses of different lengths can be easily fabricated by manufacturing only one distal or proximal element, fabricating proximal or distal elements of different lengths, and then assembling them to obtain a prosthesis of the desired length.

[0025] By creating urethral prostheses in multiple lengths using only a portion of the prosthesis, it becomes possible to obtain modular urethral prostheses of various lengths at a low cost. Furthermore, since the same system needs to be purchased, stockpiling can be simplified.

[0026] In particular, the present invention makes it possible to create an assembly kit that can be used for both female patients who require a minimum length of intraurethral prosthesis and male patients who require prostheses of different lengths depending on their anatomical features. This is, for example, in the case of an intraurethral prosthesis used to relieve urethral stricture caused by compression by an enlarged prostate, where the length of the compressed portion of the urethra may vary from patient to patient according to the size of the prostate.

[0027] With respect to International Publication No. 2020 / 089623(A2), if an excess portion of the tubular catheter or external retaining mechanism can be cut, it is avoided that the cut portion, which may contain small particles, may enter the patient's body. Furthermore, in contrast to International Publication No. 2020 / 089623(A2), where the proximal or distal stent cannot be easily provided after a portion has been cut, in the present invention the terminal stent can be maintained so that it can be provided by the manufacturer without any modification.

[0028] Preferably, the proximal tubular portion and / or distal tubular portion have a diameter set between 3 and 10 mm and a wall thickness set between 0.2 and 0.8 mm.

[0029] Alternatively, the distal portion is provided as a range of two or more parts of different lengths, and the distal tubular portion is divided into a first distal tubular element of an assigned length and a second distal tubular element provided as a range of two or more elements of different lengths, the second distal tubular element having a distal connecting end, the first distal tubular element and the second distal tubular element each having mutually liquid-tight connecting ends, and the second distal tubular element forming the middle portion of the intraurethral prosthesis. Similarly, alternatively, the proximal portion is provided as a range of two or more parts of different lengths, and the proximal tubular portion is divided into a first proximal tubular element of an assigned length and a second proximal tubular element provided as a range of two or more elements of different lengths, the second proximal tubular element having a proximal connecting end, the first proximal tubular element and the second proximal tubular element each having mutually liquid-tight connecting ends, and the second proximal tubular element forming the middle portion of the intraurethral prosthesis.

[0030] In other words, the prosthesis is made of three parts joined together, thereby allowing only the middle section to be made, or, advantageously, several sections of different lengths to obtain different lengths of the prosthesis. This makes it even easier and cheaper to address patient-to-patient anatomical differences with intraurethral prostheses, whose length can be determined at the time of implantation, thanks to the simple structure of the middle section, which can be a simple small tube with two connecting ends.

[0031] In one embodiment, the valve element is liquid-tightly arranged within at least one portion selected between a proximal tubular portion and a distal tubular portion, and the valve element includes a stopper portion, which, when the differential pressure acting on the elastic wall exceeds a predetermined opening pressure of the valve element, -Urine cannot flow through the longitudinal duct due to the deactivation / closure configuration of the valve element. -Includes an elastic wall configured to deform, which is a forced-open configuration of a valve element, allowing urine to flow through a longitudinal duct. In this way, the patient can change the configuration of the valve element from a closed configuration to an open configuration by increasing their abdominal pressure, that is, by contracting their abdominal muscles.

[0032] In this way, an intraurethral prosthesis for treating urinary incontinence is obtained, which can be controlled by a conscious patient appropriately altering the intravesical pressure, i.e., by abdominal effort strong enough to raise the intravesical pressure above the opening pressure of the valve element. The opening pressure of the valve element is set to a value lower than the pressure that could damage the bladder and the organs and tubes connected to it.

[0033] Advantageously, the elastic walls of the stopper portion are separated from each other by through slits. -In a closed configuration, the stopper portion has a shape selected from a flat shape and a convex shape having a convex surface oriented toward the proximal stent, such that the pressure of urine acting on the stopper portion keeps the through-slit closed. -In the open configuration, the stopper portion has a concave shape opposite to the possible convex shape of the stopper portion, and the through-slit is configured to deform and open, allowing urine to flow. In the closed configuration, the stopper portion is configured to withstand the pressure of the urine until the pressure of the urine no longer exceeds the release pressure. As a result, when the release pressure is exceeded, the stopper portion collapses into a concave shape.

[0034] The remarkable ease of manufacture, particularly the ease with which the opening and closing pressures of such valve elements can be predetermined, makes their use in the context of the present invention particularly advantageous.

[0035] In particular, the stopper portion has a dome shape with through slots that converge into the central region of the stopper portion.

[0036] In a preferred exemplary embodiment of the kit, - The valve element comprises an outer cylindrical montage portion that is liquid-tightly attached to the inner wall of at least one tubular portion, - The stopper portion of the valve element has a center point which is the center of the cylindrical montage portion, and - The through-slits converge to the same convergence point, which is preferably offset by a predetermined distance of at least 0.02 mm from the center point.

[0037] Thus, because the areas of the elastic walls differ slightly, the release forces acting on the elastic walls also differ from one another. Furthermore, because the areas of the elastic walls differ, the elastic walls also possess deformation energy, i.e., the minimum energy they must endure to deform to their resting-closed configuration shapes, and they do not stick to each other when they return to their resting-closed configurations.

[0038] especially, - The stopper portion includes an outer peripheral support disc with an elastic wall extending towards the center point. - The valve element has a connecting portion between the outer peripheral support disc and the montage portion, -The outer peripheral support disk is, - An outer peripheral support disc concentric with the outer cylindrical montage portion, the stopper portion being manufactured eccentrically with respect to the outer peripheral support disc, - An outer peripheral support disc that is eccentric with respect to the outer cylindrical montage portion, and the stopper portion is manufactured concentrically with respect to the outer peripheral support disc, selected from between the outer peripheral support disc and the outer peripheral support disc.

[0039] Advantageously, the two annular sealing elements protrude from the outer surface of the middle portion of the intraurethral prosthesis and are preferably positioned at the connecting end of the middle portion. This improves the tightness of the intraurethral prosthesis and also improves stabilization along the urethra.

[0040] In a favorable configuration, the middle section of the intraurethral prosthesis is axially flexible, that is, -From a linear form in which the distal part is aligned with the proximal part, that is, having a longitudinal axis in which the distal and proximal parts substantially coincide, - The proximal and distal parts are connected to each other by the elbow portion, and the joint is configured to move into a flexed position.

[0041] This allows the intraurethral prosthesis to curve along with the natural urethra, reducing the non-physiological stress placed on the natural urethra, thus alleviating pain associated with such stress, and ultimately reducing any adverse tissue reactions that may occur as a result of the prosthesis implantation.

[0042] In particular, the intermediate portion is made of a flexible polymer material that is at least partially biocompatible, and more specifically, of medical-grade silicone.

[0043] In an advantageous embodiment, the intermediate portion of the urethral prosthesis is -Two rigid connection ends, - Proximal portion and first distal tubular element, - The first proximal tubular element and the distal part, with two rigid connecting ends for connection, - It comprises an axially flexible central tubular portion made of a polymer material having a predetermined modulus of elasticity, selected from biocompatible flexible materials, particularly medical-grade silicones.

[0044] In particular, the two rigid connecting ends each comprise a cylindrical extension formed within a material having the thickness of an axially flexible central tubular section.

[0045] These embodiments and modifications allow for the relatively easy manufacture of axially flexible intraurethral prostheses.

[0046] In another embodiment, a first valve element or proximal valve element, and a second valve element or distal valve element distal thereto, are arranged liquid-tightly within the longitudinal duct. In this way, it is possible to limit the possibility that the intraurethral prosthesis may undesirably open under certain circumstances due to, for example, a violent cough or inertial action that may occur while quickly going up or down stairs.

[0047] In particular, the proximal valve element has a higher re-closing pressure than the distal valve element's opening pressure. Therefore, the longitudinal portion of the urethral prosthesis located between the proximal and distal valve elements can remove urine at the end of urination.

[0048] According to another aspect of the present invention, the above-mentioned object is achieved by an intraurethral prosthesis comprising a proximal portion and a distal portion, The proximal part is, - A proximal tubular portion configured to be positioned within the patient's urethra, and - A proximal stent configured to be reversibly fixed to the inner wall of the urethral-bladder lumen, The distal part is, - A distal tubular portion configured to be positioned inside the urethra, and - A distal stent configured to be reversibly fixed to the inner wall of the urethra, The proximal and distal tubular portions have predetermined radial rigidity and define a longitudinal duct arranged to transport urine. The valve element is liquid-tightly positioned within at least one portion selected between the proximal tubular portion and the distal tubular portion, the valve element includes a stopper portion, and the elastic wall, when the differential pressure acting on the elastic wall exceeds a predetermined opening pressure of the valve element, -Urine cannot flow through the longitudinal duct due to the deactivation / closure configuration of the valve element. -The valve element is configured to be deformable into a forced-open configuration, allowing urine to flow through the longitudinal duct. As a result, the patient can change the configuration of the valve element from a closed configuration to an open configuration by increasing their own abdominal pressure. The elastic walls of the stopper portion are separated from each other by through slits. -In a closed configuration, the stopper portion has a shape selected from a flat shape and a convex shape having a convex surface oriented toward the proximal stent, such that the pressure of urine acting on the stopper portion keeps the through-slit closed. -In the open configuration, the stopper portion has a concave shape, which is the opposite of a convex shape, and the through-slit is configured to deform and open, allowing urine to flow. In a closed configuration, the stopper portion is designed to withstand the pressure of urine until the pressure of the urine no longer exceeds the release pressure. As a result, when the pressure exceeds the release pressure, the stopper portion collapses into a concave shape. The valve element comprises an outer cylindrical montage portion that is liquid-tightly attached to the inner wall of at least one tubular portion, The stopper portion of the valve element has a center point that is the center of the cylindrical montage portion, Furthermore, the through-slits converge to the same convergence point, which is shifted by a predetermined distance from the center point.

[0049] Thus, because the areas of the elastic walls differ slightly, the release forces acting on the elastic walls also differ from one another. Furthermore, because the areas of the elastic walls differ, the elastic walls also possess deformation energy, i.e., the minimum energy they must endure to deform to their resting-closed configuration shapes, and they do not stick to each other when they return to their resting-closed configurations.

[0050] especially, - The stopper portion includes an outer peripheral support disc with an elastic wall extending towards the center point. - The valve element has a connecting portion between the outer peripheral support disc and the montage portion, -The outer peripheral support disk is, - An outer peripheral support disc concentric with the outer cylindrical montage portion, the stopper portion being manufactured eccentrically with respect to the outer peripheral support disc, - An outer peripheral support disc that is eccentric with respect to the outer cylindrical montage portion, and the stopper portion is manufactured concentrically with respect to the outer peripheral support disc, selected from between the outer peripheral support disc and the outer peripheral support disc.

[0051] Preferably, the proximal tubular portion and / or distal tubular portion have a diameter set between 3 and 10 mm and a wall thickness set between 0.2 and 0.8 mm.

[0052] In particular, the convergence point and the center point are at least 0.02 mm apart. [Brief explanation of the drawing]

[0053] The present invention will be illustrated below by describing several exemplary embodiments, not limiting them to any particular case, with reference to the accompanying drawings. [Figure 1] This diagram schematically shows urethral prostheses placed inside the urethra of female and male patients suffering from urinary incontinence. [Figure 2] This diagram schematically shows urethral prostheses placed inside the urethra of female and male patients suffering from urinary incontinence. [Figure 3] This diagram schematically illustrates the state of urethral stricture in male patients with benign prostatic hyperplasia. [Figure 4] Figure 3 schematically shows an intraurethral prosthesis placed in the urethra of the patient in order to alleviate urethral stricture. [Figure 5] This is a schematic axonometric projection of a kit comprising one specimen of the proximal portion of an intraurethral prosthesis according to one embodiment of the present invention, and multiple specimens of different lengths of the distal portion of an intraurethral prosthesis. [Figure 6] Figure 5 shows a schematic longitudinal exploded cross-sectional view of a composite kit, such as the one shown, and includes one and two valve elements positioned within longitudinal channels, respectively. [Figure 7] Figure 5 shows a schematic longitudinal exploded cross-sectional view of a composite kit, such as the one shown, and includes one and two valve elements positioned within longitudinal channels, respectively. [Figure 8] These are schematic axonometric projection, top view, and longitudinal cross-sectional view of the valve elements of a kit according to an exemplary embodiment of the present invention, where the stopper portion has a flat shape in the closed configuration. [Figure 9] These are schematic axonometric projection, top view, and longitudinal cross-sectional view of the valve elements of a kit according to an exemplary embodiment of the present invention, where the stopper portion has a flat shape in the closed configuration. [Figure 10] These are schematic axonometric projection, top view, and longitudinal cross-sectional view of the valve elements of a kit according to an exemplary embodiment of the present invention, where the stopper portion has a flat shape in the closed configuration. [Figure 11] These are schematic axonometric projection, top view, and longitudinal section view of a valve element of another exemplary embodiment of the present invention, wherein, in a closed configuration, the stopper portion has a convex shape, particularly a dome shape, and the convex surface is oriented toward the proximal end. [Figure 12] These are schematic axonometric projection, top view, and longitudinal section view of a valve element of another exemplary embodiment of the present invention, wherein, in a closed configuration, the stopper portion has a convex shape, particularly a dome shape, and the convex surface is oriented toward the proximal end. [Figure 13] These are schematic axonometric projection, top view, and longitudinal section view of a valve element of another exemplary embodiment of the present invention, wherein, in a closed configuration, the stopper portion has a convex shape, particularly a dome shape, and the convex surface is oriented toward the proximal end. [Figure 14] This is a schematic longitudinal exploded cross-sectional view of a kit, according to each exemplary embodiment of the present invention, in which the distal and proximal portions of the intraurethral prosthesis are each made of two parts, and the intermediate portion of the intraurethral prosthesis is provided by multiple specimens of different lengths. [Figure 15] This is a schematic longitudinal exploded cross-sectional view of a kit, according to each exemplary embodiment of the present invention, in which the distal and proximal portions of the intraurethral prosthesis are each made of two parts, and the intermediate portion of the intraurethral prosthesis is provided by multiple specimens of different lengths. [Figure 16] This is a schematic longitudinal exploded cross-sectional view of a kit configured similarly to the kit in Figure 14 or the kit in Figure 15, and including a valve element within a longitudinal channel. [Figure 17] This is a schematic longitudinal exploded cross-sectional view of a kit configured similarly to the kit in Figure 14 or the kit in Figure 15, and including two valve elements within a longitudinal channel. [Figure 18A] Figures 14 to 17 are schematic disassembled isometric projection views of the composite kit. [Figure 18B]These are schematic perspective and side views of a proximal or distal stent on the one hand, and a connecting element for connecting a prosthesis on the other. [Figure 18C] These are schematic perspective and side views of a proximal or distal stent on the one hand, and a connecting element for connecting a prosthesis on the other. [Figure 19] These are schematic side views of an attached intraurethral prosthesis, obtainable from the three-piece kit shown in Figures 14–17, according to variations of each exemplary embodiment, the intermediate portion of which also includes a radial sealing element. [Figure 20] Figure 19 is a schematic longitudinal cross-sectional view of the middle section of the kit. [Figure 21] These are schematic longitudinal cross-sectional views of the middle section of the kit, as shown in Figures 14 to 17, according to an exemplary embodiment. [Figure 22] These are schematic side views and isometric projection views of the rigid connection end in the middle section of Figure 21, respectively. [Figure 23] These are schematic side views and isometric projection views of the rigid connection end in the middle section of Figure 21, respectively. [Figure 24] This is a schematic side view of an attached intraurethral prosthesis, which can be obtained from one of the three-piece kits shown in Figures 14–17, according to an exemplary embodiment in which the middle section is axially flexible. [Figure 25] These are schematic exploded isoangular projection views of kits such as those shown in Figures 14-17, which are variations of each exemplary embodiment, and the proximal, intermediate, and distal sections have snap-on connection ends instead of screw connection ends. [Figure 26] Figure 15 is a schematic longitudinal section view of the proximal portion of the device according to a modified example embodiment shown, where the proximal and intermediate portions have snap-on connection ends instead of screw connection ends. [Figure 27] Figure 26 is a schematic longitudinal cross-sectional view of the proximal tubular portion of the urethral prosthesis. [Figure 28] This diagram schematically shows an intraurethral prosthesis placed in the urethra of a female animal suffering from urinary incontinence, typically a dog. [Figure 29] These are perspective views, top views, and cross-sectional views of drafts for fabricating valve elements, including elastic walls separated from each other by through-slits, before the slits are punched out, according to prior art. [Figure 30] These are perspective views, top views, and cross-sectional views of drafts for fabricating valve elements, including elastic walls separated from each other by through-slits, before the slits are punched out, according to prior art. [Figure 31] These are perspective views, top views, and cross-sectional views of drafts for fabricating valve elements, including elastic walls separated from each other by through-slits, before the slits are punched out, according to prior art. [Figure 32] Perspective, top, and cross-sectional views of a draft for fabricating a valve element in one exemplary embodiment of the present invention, in which the stopper portion includes elastic walls separated from each other by through slits, before the slits are punched out. [Figure 33] Perspective, top, and cross-sectional views of a draft for fabricating a valve element in one exemplary embodiment of the present invention, in which the stopper portion includes elastic walls separated from each other by through slits, before the slits are punched out. [Figure 34] Perspective, top, and cross-sectional views of a draft for fabricating a valve element in one exemplary embodiment of the present invention, in which the stopper portion includes elastic walls separated from each other by through slits, before the slits are punched out. [Figure 35] Figures 29 to 31 show a perspective view, a top view, and a cross-sectional view, respectively, of a valve element, which includes elastic walls separated from each other by through slits, based on the same prior art as Figures 29 to 31. [Figure 36] Figures 29 to 31 show a perspective view, a top view, and a cross-sectional view, respectively, of a valve element, which includes elastic walls separated from each other by through slits, based on the same prior art as Figures 29 to 31. [Figure 37]Figures 29 to 31 show a perspective view, a top view, and a cross-sectional view, respectively, of a valve element, which includes elastic walls separated from each other by through slits, based on the same prior art as Figures 29 to 31. [Figure 38] Figures 32 to 34 show a perspective view, a top view, and a cross-sectional view, respectively, of a valve element in the same embodiment as shown in Figures 32 to 34, which includes elastic walls in the stopper portion that are separated from each other by through slits. [Figure 39] Figures 32 to 34 show a perspective view, a top view, and a cross-sectional view, respectively, of a valve element in the same embodiment as shown in Figures 32 to 34, which includes elastic walls in the stopper portion that are separated from each other by through slits. [Figure 40] Figures 32 to 34 show a perspective view, a top view, and a cross-sectional view, respectively, of a valve element in the same embodiment as shown in Figures 32 to 34, which includes elastic walls in the stopper portion that are separated from each other by through slits. [Figure 41] Figures 35 to 37 are perspective views of the prior art valve element, and Figures 38 to 40 are perspective views of the valve element of the present invention, respectively, with the surface to which urine pressure is applied being emphasized. [Figure 42] Figures 35 to 37 are perspective views of the prior art valve element, and Figures 38 to 40 are perspective views of the valve element of the present invention, respectively, with the surface to which urine pressure is applied being emphasized. [Figure 43] Figures 35 to 40 show how the pressure of urine acting on the elastic wall of a valve element changes over time before, during, and after the physiological opening of the valve itself. [Figure 44a] Figures 35 to 37 are schematic perspective views of prior art valves, illustrating how the shape of the stopper portion changes over time during the opening event shown in Figure 43. [Figure 44b] Figures 35 to 37 are schematic perspective views of prior art valves, illustrating how the shape of the stopper portion changes over time during the opening event shown in Figure 43. [Figure 44c] Figures 35 to 37 are schematic perspective views of prior art valves, illustrating how the shape of the stopper portion changes over time during the opening event shown in Figure 43. [Figure 44d] Figures 35 to 37 are schematic perspective views of prior art valves, illustrating how the shape of the stopper portion changes over time during the opening event shown in Figure 43. [Figure 44e] Figures 35 to 37 are schematic perspective views of prior art valves, illustrating how the shape of the stopper portion changes over time during the opening event shown in Figure 43. [Figure 45a] Figures 38 to 40 are schematic perspective views of the valve of the present invention, showing how the shape of the elastic wall changes over time during the opening event shown in Figure 43. [Figure 45b] Figures 38 to 40 are schematic perspective views of the valve of the present invention, showing how the shape of the elastic wall changes over time during the opening event shown in Figure 43. [Figure 45c] Figures 38 to 40 are schematic perspective views of the valve of the present invention, showing how the shape of the elastic wall changes over time during the opening event shown in Figure 43. [Figure 45d] Figures 38 to 40 are schematic perspective views of the valve of the present invention, showing how the shape of the elastic wall changes over time during the opening event shown in Figure 43. [Figure 45e] Figures 38 to 40 are schematic perspective views of the valve of the present invention, showing how the shape of the elastic wall changes over time during the opening event shown in Figure 43. [Figure 46] Figures 35 to 37 are perspective views of prior art valve elements. [Figure 47] This is a cross-sectional view of a valve element according to a further exemplary embodiment of the present invention, wherein the stopper portion includes elastic walls separated from each other by through slits. [Figure 48] Figures 38 to 40 are side views of an integrated urethral device including a valve element. [Figure 49] Figures 38 to 40 are side views of an integrated urethral device including a valve element. [Modes for carrying out the invention]

[0054] The following is a description of a kit, i.e., a system for an intraurethral prosthesis 1 according to one aspect of the present invention, suitable for treating male and female patients with urinary incontinence, as well as male patients with benign prostatic hyperplasia (BPH) resulting in narrowing of the urethra 7 by the prostate gland 9, and several exemplary embodiments and modifications thereof of the intraurethral prosthesis 1'.

[0055] As shown in Figures 1, 2, and 4, the intraurethral prosthesis 1 is configured to be positioned in the urethra 7 of a female patient (Figure 1) or a male patient (Figures 2 and 4), preferably at the junction between the bladder 6 and the urethra 7. The intraurethral prosthesis 1 comprises a longitudinal intraurethral duct 5 suitable for transporting urine 99 contained in the bladder 6, and fixing means 21 and 49 for stably, but reversibly, positioning the intraurethral prosthesis 1 in a predetermined position within the urethra 7.

[0056] The means of fixation to the urethra 7 preferably comprises a proximal stent 21 and a distal stent 49. In this specification, the adjectives "proximal" and "distal" refer to patients who have an intraurethral prosthesis 1 implanted.

[0057] The proximal stent 21 and distal stent 49 are configured to be elastically deformable from an expanded, stationary configuration shown in the figure, each having a radial dimension larger than the natural radial dimension of the urethra 7, to a contracted, forced configuration, in which the radial dimensions of the proximal stent 21 and distal stent 49 can be elastically contracted so that the intraurethral prosthesis 1 can be inserted into the lumen of the urethra 7 and slide within it until the intraurethral prosthesis 1 reaches a predetermined implantation position within the urethra 7.

[0058] In the non-limiting embodiment shown in the figure, the proximal stent 21 is configured to elastically anchor itself to the inner wall 6' of the bladder 6 at the opening of the urethra 7, so as to prevent the intraurethral prosthesis 1 from moving distally after implantation and eventually being expelled from the urethra 7.

[0059] More specifically, in the embodiment shown in the figure, the proximal stent 21 may comprise a plurality of elongated anchor elements 22 (see, for example, Figure 5), each having a first end attached to a circumferential position of a continuous proximal connecting ring 27a and a second end attached to a respective ring segment, the flexible ring segments forming a connecting ring 27b for connection to the body of the intraurethral prosthesis 1, for example, in a manner further described below. The elongated anchor elements 22 are elastically flexible between a bent, stationary form, shown overall in the figure, corresponding to the expanded, stationary configuration of the proximal stent 21, and an expanded, forced form, not shown, corresponding to the contracted, forced configuration of the proximal stent 21.

[0060] In this embodiment, the distal stent 49 is configured to be elastically fixed to the inner wall 7' of the urethra 7, thereby preventing the intraurethral prosthesis 1 from moving proximally and eventually entering the bladder 6 after implantation.

[0061] More specifically, in the embodiment shown in the figure, the distal stent 49 may comprise a plurality of radial fixation elements 48 (see, for example, Figure 5), each projecting radially from the central element and elastically movable from an expanded resting position, generally shown in the figure, corresponding to an expanded resting configuration of the distal stent 49, and a contracted forced position, not shown, corresponding to a contracted forced configuration of the distal stent 49. The central element of the distal stent 49 comprises a plurality of elongated flexible portions, each flexible portion having one end attached to its respective ring segment, the flexible ring segment forming a connecting ring 48a (see, for example, Figures 18A and 25) for connection to the body of the intraurethral prosthesis 1, for example, in a manner further described below.

[0062] More specifically, Figure 1 shows the implantation of an intraurethral prosthesis 1 into the urethra of a female patient, where the urethra 7 extends between the patient's bladder 6 and the patient's vulvar vestibule 7'', while Figure 2 shows the implantation of an intraurethral prosthesis 1 into the urethra 7 of a male patient, where the urethra 7 extends between the patient's bladder 6 and the patient's glans penis 8'' through the patient's penis 8''.

[0063] Figure 3 schematically illustrates the stricture of the urethra 7 due to prostatic hypertrophy 9 in a male patient, and shows the striated muscle that controls the natural external urethral sphincter 9' downstream of the region of urethra 7 affected by the stricture, and Figure 4 schematically illustrates an intraurethral prosthesis 1 used to relieve the stricture. In this case, the intraurethral prosthesis 1 has a length that does not interfere with the natural external urethral sphincter 9, which may need to maintain its function in patients without urinary incontinence. For this purpose, the intraurethral prosthesis 1 has an adjustable length, which is made possible by the kit according to the present invention in the manner described below.

[0064] Referring to Figures 5 to 7, a kit including the proximal 2 and distal 4 portions of the intraurethral prosthesis 1 is described in three different exemplary embodiments.

[0065] In the kits shown in Figures 5-7, the proximal portion 2 is provided as a single piece of length L2, while the distal portion 4 is provided as multiple pieces of different lengths L4. Three pieces 4 are shown non-limitingly in the figures; in other words, 2, 3, 4...n pieces 4 of different lengths L4 may be provided in the kit. In this way, it is possible to assemble an intraurethral prosthesis 1 which may have different lengths L1 corresponding to combinations of lengths L2 and L4 of one proximal portion 2 and one proximal portion 4, selected according to the requirements of the implant to be performed, mainly according to the specific anatomical features of the patient.

[0066] Figures 6, 7, 14, and 15 are exploded longitudinal cross-sectional views of the composite kit. In all of these figures, the length of the intraurethral prosthesis 1, the length of the distal portion 4 in Figure 14, and the length of the proximal portion 2 in Figure 15 are represented conventionally for clarity, including the "empty" space in the exploded view of the cited portion.

[0067] The first case of anatomical deformity can be understood by considering Figures 3 and 4, where the distance of the external urethral sphincter 9 from the opening of the urethra 7 can have different values, as can the stricture of the urethra 7 caused by compression by an enlarged prostate 9, which can have various lengths depending on the size of the patient's prostate 9. The second, more common case of anatomical deformity, relating to female patients, is in which case the urethra is shorter, and it is advantageous that the intraurethral prosthesis 1 has the minimum length, and as a result the implantation is minimally invasive.

[0068] Clearly, according to embodiments not shown, the assembly kit includes a distal portion 4 provided as a single piece of length L4 and a proximal portion 2 provided as multiple pieces of different lengths L2, or both the proximal portion 2 and the distal portion 4 provided as multiple pieces of different lengths L2 and L4.

[0069] More specifically, the proximal portion 2 is, for example, in the aforementioned form, for fixation to the inner walls 6' and 7' of the bladder 6 and urethra 7 in the internal urethral sphincter, with a length L 21 Suitable for placement as a proximal stent 21 and within the urethra 7, with a length L 24 It comprises a proximal tubular portion 24. Similarly, each sample of the distal portion 4 has a length L 49 The aforementioned distal stent 49 having a length L 46The prosthesis comprises a distal tubular portion 46 having a distal tubular portion 24 and a distal tubular portion 46, which are also suitable for placement within the urethra 7. The prosthesis 1 and the distal tubular portion 46 have a predetermined radial rigidity and together form a longitudinal urethral duct 5, and the urethral duct 5 has sufficient rigidity to maintain its shape under implantation conditions, for example, under the implantation conditions of Figure 4 in which an enlarged prostate 9 exerts a contractile force on the outer wall of the urethra 7, and under substantially permanent conditions of another patient, for example, in the presence of excess adipose tissue.

[0070] Preferably, the proximal tubular portion 24 and the distal tubular portion 46, and therefore the longitudinal duct 5, have a diameter set to 3 to 10 mm and a wall thickness set to 0.2 to 0.8 mm.

[0071] The proximal tubular portion 24 and the distal tubular portion 46 each have a distal end 23 and a proximal end 47 that connect to the proximal stent 21 and the distal stent 49, respectively. The opposing ends 23 and 47, the proximal tubular portion 24 and the distal tubular portion 46 each have a proximal connecting end 29 and a distal connecting end 31 that are liquid-tightly connected to each other and are therefore configured to connect the proximal portion 2 and the distal portion 4 to form an intraurethral duct 5.

[0072] In the embodiment shown in Figure 5, the urethral duct 5 is positioned to allow urine 99 to flow continuously. In other words, in this case, the urethral prosthesis 1 does not have a means to stop the flow and is suitable for the type of application shown in Figure 4, for example, to treat urethral stricture caused by an enlarged prostate 9. The length L1 is short enough to prevent the external urethral sphincter 9 from reaching the natural external urethral sphincter 9 and is obtained by appropriately selecting a component of length L4 that is suitable as the distal part of the urethral prosthesis 1 itself when assembling the urethral prosthesis 1, or, in an alternative embodiment, by appropriately selecting a component of length L2 that is suitable as the proximal part of the urethral prosthesis 1.

[0073] On the other hand, the urethral duct 5 of the urethral prosthesis 1 according to the embodiment shown in Figure 6 surrounds a valve element 50 that is arranged to stop or allow the flow of urine 99 through the urethral duct 5 in a pause-closed configuration and a forced-open configuration, respectively.

[0074] Figures 8-10 and 11-13B show two exemplary valve elements 50, where the stopper portion 56 is such that the differential pressure ΔP acting on the elastic wall 55 is such that the valve element 50 has a predetermined characteristic opening pressure P * The valve is equipped with an elastic wall 55 that is configured to deform from a statically closed configuration shown in Figures 8 to 13A to a forced-open configuration shown in Figure 13B when the pressure exceeds a certain level. Of course, those skilled in the art can implement different types of valve elements.

[0075] The urethral prosthesis 1 according to the exemplary embodiment shown in Figure 6 and other embodiments described below is suitable for treating both conscious male or female patients and unconscious male or female patients suffering from urinary incontinence.

[0076] In particular, in conscious patients with an intraurethral prosthesis 1, the configuration of the valve element 50 can be changed from a closed configuration to an open configuration by spontaneous abdominal effort that increases abdominal pressure. When this force is released, the elastic wall 55 elastically returns the valve element 50 to its resting closed configuration, thus allowing urine 99 to physiologically accumulate again in the bladder 6 for a new cycle without any leakage.

[0077] On the other hand, in unconscious patients, such valve element 50 releases pressure P when the intrabladder pressure is reduced. * When a critical value substantially equal to is exceeded, the bladder 6 is made physiologically empty, and thus the bladder and the organs and ducts hydraulically connected to it are prevented from being damaged by excessive internal pressure. This is achieved by suitably selecting the physical and geometric properties of the valve member 50, in particular the spring-elastic wall 55, thereby controlling the release pressure P * If it is set up correctly, it is clearly possible.

[0078] Since the intraurethral prosthesis 1 of FIG. 6 is controlled by a physiological increase in intravesical pressure, such a device is suitable for treating animals, typically female animals, having urinary incontinence, as schematically shown in FIG. 28.

[0079] The valve element 50 of the kit of FIG. 6 is disposed within the proximal portion 2 of the intraurethral prosthesis 1, and more particularly within the proximal tubular portion 24. However, in an alternative embodiment not shown, it may be disposed within the distal portion 4, particularly within the distal tubular portion 46.

[0080] In the valve element 50 of the embodiment shown in FIGS. 8 - 13B, the elastic wall 55 is disposed radially and separated from each other by a through slit 57, in which case it converges to a preferably central region 58 of the stopper portion 56 of the valve element 50.

[0081] Particularly, in the closed configuration, the stopper portion 56 of the valve element 50 of FIGS. 8 - 10 has a flat shape, while the stopper portion 56 of the valve element 50 of FIGS. 11 - 13B has a convex shell shape, not shown, with the convex side facing the bladder side, i.e., oriented towards the proximal stent 21, and the urine pressure acting on the convex shell shape 56 forms a diaphragm to keep the slit 57 closed as long as the urine pressure 99 does not exceed the opening pressure P * In other words, the stopper portion 56 is configured to withstand such urine pressure until the urine pressure reaches the opening pressure P * When the opening pressure P * is reached, the stopper portion 56 collapses into a concave shape opposite to the convex shape, the through slit 57 is deformed, the stopper portion 56 opens as shown in FIG. 13B, and allows urine 99 to flow through the longitudinal duct 5 and thus through the urethra 7.

[0082] Figure 7 shows a kit according to another embodiment, which differs from the kit in Figure 6 in that it has two valve elements 50 and 50' instead of one. In the modified example shown in the figure, the proximal valve element 50 is located within the proximal section 2, particularly within the proximal tubular section 24, and the distal valve element 50' is located within the distal section 4, particularly within the distal tubular section 46. However, in a modified example of such a kit not shown, both valve elements 50 and 50' may be located in the proximal section 2, or both may be located in the distal section 4. Preferably, in these cases, the proximal valve element 50 has a re-closing pressure higher than the opening pressure of the distal valve element 50', so that the section of the longitudinal duct 5 between the proximal valve element 50 and the distal valve element 50' is cleared of urine 99 after its discharge.

[0083] As illustrated with reference to Figure 7, in a similar embodiment including two valve elements, different valve elements may be used, as described below with reference to Figures 32-34, 38-40, 42, and 47.

[0084] Referring to Figure 14, a kit is described that includes a proximal 2 and distal 4 of an intraurethral prosthesis 1 according to one embodiment of the present invention, which differs from the kit in Figure 6 in that the distal tubular portion 46 is divided into a first distal tubular element 35 and a second distal tubular element 45, each having a distal end 31 for connection to the proximal portion 2. The first distal tubular element 35 and the second distal tubular element 45 each have a liquid-tight interconnect end 37 and a liquid-tight interconnect end 44, respectively.

[0085] The first distal tubular element 35 has a length L 35 It is provided as a single piece, while the second distal tubular element 45 has a different length L 45 It is made up of multiple pieces. Therefore, the second distal tubular element 45 has different lengths L 45 and the length L of the first distal tubular element 35 35 In response to the combination, the distal tubular portion 46 has the same multiple different lengths L 46 Since it is provided, the different lengths L of the distal tubular portion 46 46and the length L of the distal stent 49 49 Corresponding to the combination, the distal portion 4 is provided in multiple different lengths L4. Three pieces 45 are shown non-limitingly in the figure, in other words, different lengths L 45 There may be 2, 3, 4...n pieces 45 provided.

[0086] Referring to Figure 15, a kit including a proximal portion 2 and a distal portion 4 of an intraurethral prosthesis 1 is described according to an embodiment of the present invention, where the proximal portion 2 is provided by multiple pieces of different lengths L2, while the distal portion 4 is provided by a single piece of length L4. The proximal tubular portion 24 is divided into a first proximal tubular element 25 and a second proximal tubular element 34 having a proximal connecting end 29 for connecting to the distal portion 4. The first proximal tubular element 25 and the second proximal tubular element 34 have, respectively, liquid-tight interconnecting ends 28 and 33.

[0087] The first proximal tubular element 25 is a single piece of length L. 25 The second proximal tubular element 34 is provided as multiple pieces of different lengths L. 34 It is provided in this way. For this reason, the second proximal tubular element 34 has different lengths L 34 and the length L of the first proximal tubular element 25 25 In response to the combination, the proximal tubular portion 24 has the same multiple different lengths L 24 The proximal portion 2 is provided, and the proximal tubular portion 24 has different lengths L 24 and the length L of the proximal stent 21 21 In response to the combination, the same multiple different lengths L2 are provided. Three pieces 34 are shown non-restrictively in the figure, in other words, different lengths L 34 There may be 2, 3, 4...n pieces 34 provided.

[0088] In the kits of Figures 14 and 15, the second distal tubular element 45 and the first distal tubular element 34, each of varying lengths, form the intermediate portion 3 of the intraurethral prosthesis 1 that can be obtained from such a kit. Thus, in another view, Figures 14 and 15 refer to a kit of the intraurethral prosthesis 1 including a proximal portion 2 or proximal portions 21 to 24, an intermediate portion 3, and distal portions 35 to 49 or distal portion 4, where the intermediate portion 3 is provided by multiple pieces of different lengths L3.

[0089] The intraurethral prosthesis 1 obtained from the kit shown in Figures 14 and 15, like the intraurethral prosthesis obtained from the kit shown in Figure 3, does not have a flow-stopping means in the longitudinal duct 5, so it is configured to allow urine 99 to flow at all times and is suitable for treating urethral stricture 7 due to benign prostatic hyperplasia. For this reason, in Figures 14 and 15, the reference numeral 3 is added in parentheses next to the reference numeral 45 of the second distal tubular element of the distal tubular portion 46 and next to the reference numeral 34 of the second proximal tubular element of the proximal tubular portion 24, respectively.

[0090] The kit shown in Figure 16 differs from the kits in Figures 14 and 15 in that the longitudinal duct 5 surrounds the valve element 50 of the type described above, for example, the type shown in Figures 8 to 13B. Therefore, the intraurethral prosthesis 1 that can be obtained from such a kit is suitable for treating patients suffering from urinary incontinence, similar to the intraurethral prosthesis that can be obtained from the kit shown in Figure 6.

[0091] Figure 17 shows a kit according to another exemplary embodiment, which differs from the kit in Figure 16 in that it comprises two valve elements 50 and 50' instead of one. In the modified embodiment shown in the figure, the proximal valve element 50 is located in the first proximal tubular element 25 and thus within the proximal portion 2, while the distal valve element 50' is located in the distal tubular portion 46 and thus within the distal portion 4. However, in a modified embodiment of the kit not shown, one or both of the valve elements 50 and 50' may be located within the proximal portion 2 or proximal portions 21 to proximal portion 24, or within the intermediate portion 3, or within distal portions 35 to distal portion 49 or distal portion 4 of the intraurethral prosthesis 1.

[0092] Figure 18A schematically shows, in exploded isometric projection, kits according to modifications of exemplary embodiments shown in Figures 14 to 17. In particular, the set of components shown along axes 1a, 1b, and 1c constitutes the kits of Figures 14 and 15. Including the components shown along axis 1d, the set thus obtained constitutes the kit of Figure 16, and further including the components shown along axis 1e, the set thus obtained constitutes the kit of Figure 17.

[0093] Figure 18A also shows a method for attaching the proximal stent 21 and distal stent 49 to the first proximal tubular element 25 and distal tubular element 35, respectively, and a method for attaching the valve element 50 and valve element 50', if present (axis 1d and axis 1e, respectively). For this purpose, a connecting element 60 is provided, which is shown in detail in Figures 18B and 18C, the connecting element 60 comprising a cylinder, from which a first radial projection 61 protrudes from the outer surface of the cylinder, preferably uniformly and angularly spaced apart, extending longitudinally over the entire height of each connecting element 60, and a second radial projection 62 protruding, the second radial projection 62 having a generally circular cross-sectional area, preferably alternating circumferentially with the first radial projection 61 at half the height of the connecting element 60. The first radial projection 61 and the second radial projection 62 are arranged to engage with through-cavities 66 and 63 in the same order between the respective flexible ring segments of the connecting rings 27b and 48a of the proximal stent 21 and distal stent 49, and to engage with the corresponding through-cavities 64 and 65 formed in the connecting end portions of the first proximal tubular element 25 and distal tubular element 35. More specifically, the connecting rings 27b and 48a of the proximal stent 21 and distal stent 49 (see, for example, Figure 5) are inserted radially between the inner surfaces of the connecting ends of the first proximal tubular element 25 and distal tubular element 35 and the outer surface of the cylinder of the corresponding connecting element 60. Preferably, as shown in the equivalent embodiment of Figure 26, the second radial projection 62 is configured to tightly engage with the through-cavities 63 and 65, and in particular, the second radial projection 62 includes a guide portion formed by a chamfer in the insertion direction of the connecting element 60.

[0094] Figure 19 shows an attached intraurethral prosthesis that can be obtained from a kit according to a modification of any of the embodiments in Figures 14 to 17, wherein the intermediate portion 3 is preferably made of a polymer material and comprises two deformable radial sealing elements 32 projecting radially at connecting end 31, connecting end 44 or connecting end 33, connecting end 29. As shown in Figure 20, the radial sealing elements 32 may be flat rings, or in a modification not shown, they may be simple O-rings.

[0095] Figures 21 to 23 show exemplary embodiments of the intermediate section 3 of any of the kits in Figures 14 to 17, the intermediate section 3 comprising an axially flexible, elongated central body 36 preferably made of a biocompatible polymer material, such as medical-grade silicone, and two rigid connecting ends 30 and 40 preferably made of a metallic material, the rigid connecting ends 30 and 40 comprising ends 31 and 44 (Figure 14) for connecting to the proximal section 2 and the first distal tubular element 35, or ends 33 and 29 (Figure 15) for connecting to the first proximal tubular element 25 and the distal section 4. In this way, the intermediate section 3 is axially flexible, and therefore the intraurethral prosthesis 1 is also axially flexible. A linear form (A) and a bent form (B) of such an intraurethral prosthesis 1 are shown in Figure 24 by dotted and solid lines, respectively. The connecting ends 31, 44, 33, and 29 are shown non-limitingly as threaded ends.

[0096] Referring further to Figures 21 to 23, the ends 30 and 40 are provided with cylindrical extensions 30' and 40' on the opposite side of the connecting ends 31, 44, or 33 and 29. The cylindrical extensions 30' and 40' are preferably molded within the polymer central body 36. Advantageously, the cylindrical extensions 30' and 40' have through-grip holes 39 to improve the fixation of the ends 30 and 40 to the polymer central body 36.

[0097] In the aforementioned figures, the connecting ends 29 and 31 of the upper proximal section 2 and the lower distal section 4, and the connecting ends 31, 44, or 33, 29, and the corresponding connecting ends 28 and 37 of the intermediate section 3 and the parts connected thereto, are represented as threaded connecting ends. However, these connecting ends may be of different types, and in particular, they may be snap and interlocking connecting ends, as shown in Figures 25 and 26, which are overview representations of multiple kits equivalent to Figure 18.

[0098] With reference to Figures 29 to 47, improved valve elements 150 and 250 according to another aspect of the present invention will be described. The aforementioned intraurethral prosthesis 1 may be equipped with such improved valve elements 150 and 250.

[0099] The valve elements 150 and 250 are liquid-tightly positioned within one portion selected between the proximal tubular portion 24 and the distal tubular portion 46. Similar to the valve elements 50 and 50' described (Figures 8 to 13B), the valve elements 150 shown in Figures 38 to 40 and 250 shown in Figure 47 include stopper portions 156 and 256, each having elastic walls 155 and 255. In this case as well, the differential pressure ΔP acting on the elastic walls 155 and 255 is the predetermined opening pressure P of the valve elements 150 and 250. * When the pressure exceeds a certain level, the elastic walls 155 and 255 are configured to deform from a static closed configuration in which urine 99 cannot flow through the longitudinal urethral duct 5 to a forced open configuration of a valve element in which urine 99 can flow through the longitudinal urethral duct 5. In this way, the patient can release the abdominal pressure P * By increasing the height, the configuration of valve element 150 and valve element 250 can be changed from a closed configuration to an open configuration.

[0100] The idle-closed configuration and the forced-open configuration for the valve element 150 are shown in Figures 42, 45a, and 45c, respectively.

[0101] More specifically, the stopper portion 156, the elastic wall 155 of the stopper portion 256, and the elastic wall 255, which converge to the same convergence point 158 ​​and convergence point 258, are separated from each other by multiple through slits 157 and through slits 257.

[0102] In the static closure configuration (Figures 42 and 45a), the stopper portions 156 and 256 have a flat or convex shape, for example, a dome shape (not shown), with the convex side facing the bladder, i.e., oriented toward the proximal stent 21. Therefore, the urine pressure acting upstream of the stopper portions 156 and 256 is such that the urine pressure is equal to the release pressure P. * Provided that it does not exceed the opening pressure P, slits 157 and 257 remain closed. * When it reaches this point, the stopper portions 156 and 256 collapse into a concave shape opposite to their convex shape, the through slits 157 and 257 deform, and the stopper portions 156 and 256 open as shown in Figure 45c, allowing urine 99 to flow through the longitudinal duct 5 and therefore through the urethra 7.

[0103] The elastic walls 155 and 255 are preferably obtained from flat or convex thin films 153 and 253 by forming through slits 157 and 257 by punching. A similar manufacturing procedure may be used to obtain the valve element 50 shown in Figures 8 to 13B.

[0104] In these embodiments, four elastic walls 55, elastic wall 155, and elastic wall 255 are shown, and two intersecting through slits 57, through slit 157, and through slit 257 are shown, but it is clear that different numbers of elastic walls and through slits can be provided. For example, sets of three elastic walls and three converging slits, sets of five elastic walls and five converging slits, sets of six elastic walls and six converging slits, and so on can be provided.

[0105] Furthermore, the valve elements 150 and 250 each include at least one tubular portion 24, a tubular portion 46, and outer cylindrical montage portions 167 and 267 that are liquid-tightly attached to the inner wall of the longitudinal duct 5. Preferably, the outer cylindrical montage portions 167 and 267 have a circular cross-section. The center points 159 and 259 of the valve elements 150 and 250 are defined with respect to the cylindrical montage portions 167 and 267. More precisely, center points 159 and 259 are the intersections of the central longitudinal axis 54 of the valve elements 150 and 250 (of the cylindrical montage portion 167 and cylindrical montage portion 267) and the thin films 153 and 253 from which elastic walls 155 and 255 are obtained by creating through-slits 157 and 257, i.e., the surface of a planar or axisymmetric shell from which thin films 153 and 253 can be approximated.

[0106] In the improved valve elements 150 and 250, the convergence points 158 and 258 where the through-slits 157 and 257 converge are offset by a predetermined distance δ from the center point 159 and 259. Preferably, the distance δ is at least 0.02 mm, and in particular, δ is set to 0.02 to 1 mm.

[0107] The stopper portion 156 and the stopper portion 256 preferably include an elastic wall 155, an outer peripheral support disc 170, and an outer peripheral support disc 270 on which the elastic wall 255 extends centripetically toward the center point 159 and the center point 259. The outer peripheral support disc 150 corresponds to the outer peripheral portion of the membrane 153, which remains unchanged when the through slit 157 and the through slit 257 are formed. The connection portion of the valve element 150 and the valve element 250 is also provided between the aforementioned outer peripheral support disc 170 and the outer peripheral support disc 270 and the montage portion 167 and the montage portion 267.

[0108] Figures 38 to 40 show a valve element 150 according to an exemplary embodiment, in which the outer peripheral support disk 170, and therefore the membrane 153, is concentric with the outer peripheral cylindrical montage portion 167, while the stopper portion 156 is manufactured eccentrically with respect to the membrane 153, and therefore the radial width of the outer peripheral support disk 170 varies along the circumference of the membrane 153. Figures 32 to 34 show a draft 150' for making the valve element 150, i.e., before the slit 157 is made to obtain the elastic wall 155 from the central portion of the membrane 153, in particular before the membrane 153 is punched out to create the through slit 157. In this case, the slit 157 is obtained by positioning the punching device eccentrically with respect to the membrane 153. In particular, the cutting edge of the blade of such a punching device, whose length is twice the length of one through slit 157, is eccentric with respect to the outer cylindrical montage portion 167, i.e., its midpoint (not shown) is positioned at a distance δ from the center point 159, in order to punch out the first two slits as the same straight cut with respect to the membrane 153. The cutting edge is then rotated 90° around a rotation axis 171 that is parallel to the central longitudinal axis 54 of the valve element 150 and passes through the midpoints of the punched cuts corresponding to the first two through slits 157, after which the last two slits are punched. The convergence point 158 ​​coincides with the intersection of the rotation axis 171 and the membrane 153, and is located at a distance δ from the center point 159.

[0109] In the valve element 150, the eccentricity of the slit 157 and membrane 153, or the outer cylindrical montage portion 167, or the valve element 150 itself, is obtained by eccentrically punching out the same symmetrical draft 50a that would have been used to produce the symmetrical valve element 50. For comparison, in the embodiments of Figures 29-31 and 35-37, the rotation axis 71 of the punching device and the convergence point 58 of the through slit 155 coincide with the longitudinal axis 54 of the draft 5', which ultimately corresponds to the longitudinal axis 54 of the symmetrical valve element 50.

[0110] Figures 41 and 42 show valve elements 50 and 150 according to the prior art and the above embodiment of the present invention, respectively, and are the same figures as Figures 35 and 38, respectively, except for the hatched areas, which correspond to the surface on which the urine pressure P acts. A typical trend of urine pressure in a cycle involving the accumulation of urine 99 in the bladder 6 and the subsequent release of urine by opening the valve elements is shown in Figure 43, and at a specific moment in the cycle t a ~t e This is shown.

[0111] Figures 44a to 44e and 45a to 45e show how the elastic wall 55 of the prior art valve element 50 and the elastic wall 155 of the valve element 150 according to the present invention change their positions as the urine pressure P changes, as shown in Figure 43. Figures 44a to 44e and 45a to 45e are shown in the same order as time t a ~t e Corresponds to time t a In this case, the bladder 6 is empty, and the urine pressure P is the open pressure P * When time t is much lower than 0, both valve element 50 and valve element 150 are in a closed configuration, i.e., the elastic walls 55 and 155 are in complete contact with each other by the longitudinal slits 57 and 157 (Figures 44a and 45a). b In this case, the pressure of urine is the release pressure P * When the valve element 44 of the prior art is nearly reached (corresponding to the maximum opening of the valve), the valve element 45 of the prior art is still substantially closed, while the valve element 45 has already shown a small partial opening of the valve element 150, which demonstrates the faster response capability of the valve element 150 compared to the valve element 50 of the prior art. c In this case, the pressure of urine is the release pressure P * When this is reached, the valve element 150 is fully open, while the valve element 50 of the prior art can show a narrowed passage relative to the valve element 50, and the urine pressure P is reached at time t d and t eAt zero, the elastic walls 55 and 155 elastically recover to their respective resting closed configurations. However, as shown in Figure 44e, the elastic walls 55 of the prior art valve 50 may stick together at the end of the cycle, and the prior art valve 50 may exhibit a residual passage even when urine is not present above the stopper element 56, which can cause urine leakage, whereas this is never the case with respect to the valve element 150 which is completely closed (see Figure 45e).

[0112] Figure 47 shows a valve element 250 according to another exemplary embodiment, where the outer peripheral support disc 270, and therefore the membrane 253, is eccentric with respect to the outer peripheral cylindrical montage portion 267, and the stopper portion 256 is manufactured concentrically with respect to the membrane 253, so that the radial width of the outer peripheral support disc 270 does not change along the circumference of the membrane 253. In this case, the slits 257 can be obtained by positioning the punching device concentrically with respect to the membrane 253. In particular, the cutting edge of the punching device blade is positioned concentrically with respect to the membrane 253, and therefore eccentrically with respect to the outer peripheral cylindrical montage portion 267, i.e., its midpoint (not shown) is located at a distance δ from the center point 259, so that the first two slits are punched as the same straight cut. Next, the cutting edge is rotated 90° around a rotation axis 271 that coincides with the longitudinal axis 54 of the valve element 250 and passes through the midpoint of the punch cuts corresponding to the first two through slits 257, after which the last two slits are created. In this case as well, the convergence point 258 coincides with the intersection of the rotation axis 272 and the film 253, and is located at a distance δ from the center point 259.

[0113] Regarding the displacement of the elastic wall 255 due to the increase and subsequent decrease in urine pressure acting on the valve element 150, as shown in Figure 43, and the opening and closing of the valve element 250, similar behavior to that of the valve element 250 was observed, as shown in Figures 45a to 45e.

[0114] According to a further aspect of the present invention, an integrated intraurethral prosthesis 1' is provided, including the improved valve elements 150 and 250 described above, as shown in Figures 48 and 49.

[0115] The intraurethral prosthesis 1' comprises a proximal portion 2 and a distal portion 4, which are integral to each other and have predetermined radial rigidity, including a proximal tubular portion 24 and a distal tubular portion 46. The proximal tubular portion 24 and the distal tubular portion 46 are configured to be positioned within the patient's urethra 7, and the proximal stent 21 and the distal stent 49 are configured to be reversibly fixed, respectively, to the urethral-vesicle lumen 6-7 and the inner wall of the urethra 7 in female or male patients suffering from urinary incontinence (see Figures 1 and 2, respectively). Together, the proximal tubular portion 24 and the distal tubular portion 46 form a longitudinal intraurethral duct 5 that is rigid enough to maintain its shape under implantation conditions.

[0116] Advantageously, the surface of the intraurethral prosthesis 1 or intraurethral prosthesis 1' that comes into contact with the patient's tissue is coated with a biocompatible material, preferably selected from hydrophilic medical-grade silicone and / or hydrogel having antifouling and antimicrobial properties, and in particular selected from the group consisting of amphoteric polymers, polyethylene glycol, or combinations thereof. In particular, hydrogels can be combined with polydopamine to improve long-term adhesion on the coated surface.

[0117] The above descriptions of exemplary embodiments and modifications thereof of the present invention are intended to present the invention conceptually, so that others may modify and / or adapt such particular embodiments and modifications thereof to various uses using known art without further investigation and without departing from the concept of the present invention, and it is understood that such adaptations and modifications are equivalent to the embodiments and modifications thereof. The means and materials for achieving the various functions described herein may be of various kinds without departing from the scope of the present invention. It is understood that the expressions or terms used are merely descriptive and therefore not limiting.

Claims

1. An intraurethral prosthesis (1') comprising a proximal portion (2) and a distal portion (4), The proximal portion (2) is, - A proximal tubular portion (24) configured to be positioned within the patient's urethra (7), and - A proximal stent (21) is provided, which is configured to be reversibly fixed to the inner wall (8) of the urethral-bladder lumen (6-7), The distal portion (4) is - A distal tubular portion (46) configured to be positioned within the urethra (7), and - A distal stent (49) is provided, configured to be reversibly fixed to the inner wall (8) of the urethra (7), The proximal tubular portion (24) and the distal tubular portion (46) have a predetermined radial rigidity and define a longitudinal duct (5) arranged to transport urine (99). The valve elements (150, 250) are liquid-tightly positioned within at least a portion between the proximal tubular portion (24) and the distal tubular portion (46), and the valve elements (150, 250) include stopper portions (156, 256), the stopper portions (156, 256) are provided with elastic walls (155, 255), and the differential pressure (ΔP) acting on the elastic walls (155, 255) is such that the valve elements (150, 250) have a predetermined opening pressure (P ＊ ) If it exceeds this, - From the deactivation and closure configuration of the valve elements (150, 250) such that the urine (99) cannot flow through the longitudinal duct (5), - The valve elements (150, 250) are configured to be deformed into a forced-open configuration that allows the urine (99) to flow through the longitudinal duct (5). As a result, the patient can change the configuration of the valve elements (150, 250) from the closed configuration to the open configuration by increasing their abdominal pressure. The elastic walls (155, 255) of the stopper portion (156, 256) are separated from each other by a plurality of through slits (157, 257), - In the closed configuration, the stopper portions (156, 256) have a shape selected from a flat shape and a convex shape having a convex surface oriented toward the proximal stent (21), such that the pressure of urine acting on the stopper portions (156, 256) keeps the through-slits (157, 257) closed. - In the open configuration, the stopper portions (156, 256) have a concave shape opposite to the convex shape, and the through slits (157, 257) are configured to deform and open, allowing the flow of urine (99). In the closed configuration, the stopper portion (156, 256) is such that the pressure of the urine is equal to the release pressure (P ＊ It is configured to withstand the pressure of the urine until it no longer exceeds the release pressure (P ＊ When it exceeds the limit, the stopper portion (156, 256) collapses into the concave shape, The valve element (150, 250) comprises an outer cylindrical montage portion (167, 267) that is liquid-tightly attached to the inner wall of at least one tubular portion (24, 46), The stopper portion (156, 256) of the valve element (150, 250) has a center point (159, 259) which is the center of the cylindrical montage portion (167, 267), The intraurethral prosthesis (1') is characterized in that the through-slits (157, 257) converge to the same convergence point (158, 258) which is shifted by a predetermined distance (δ) from the center point (159, 259).

2. The stopper portion (156, 256) comprises an outer peripheral support disc (170, 270) whose elastic wall (155, 255) extends centripetically toward the center point (159, 259), The valve elements (150, 250) are provided with connecting portions (168, 268) between the outer peripheral support discs (170, 270) and the montage portions (167, 267), The urethral prosthesis (1') according to claim 1, wherein the outer peripheral support discs (170, 270) are concentric with the outer peripheral cylindrical montage portion (167, 267), and the stopper portion is manufactured eccentrically with respect to the outer peripheral support discs (170, 270).

3. The stopper portion (156, 256) comprises an outer peripheral support disc (170, 270) whose elastic wall (155, 255) extends centripetically toward the center point (159, 259), The valve elements (150, 250) are provided with connecting portions (168, 268) between the outer peripheral support discs (170, 270) and the montage portions (167, 267), The urethral prosthesis (1') according to claim 1, wherein the outer peripheral support discs (170, 270) are eccentric with respect to the outer peripheral cylindrical montage portion (167, 267), and the stopper portion is manufactured concentrically with respect to the outer peripheral support discs (170, 270).

4. The urethral prosthesis (1') according to claim 1, wherein the proximal tubular portion (24) and / or the distal tubular portion (46) have a diameter set between 3 and 10 mm and a wall thickness set between 0.2 and 0.8 mm.

5. The intraurethral prosthesis (1') according to claim 1, wherein the convergence point (158, 258) and the center point (159, 259) are at least 0.02 mm apart (δ).

6. The proximal tubular portion (24) and the distal tubular portion (46) each have a proximal connecting end (29) and a distal connecting end (31) on opposite sides of the proximal stent and the distal stent (21, 49), respectively, which are liquid-tightly connected to each other and configured to connect the proximal portion (2) and the distal portion (4). To define the single longitudinal duct (5), the longitudinal duct consists of the proximal tubular portion (24) and the distal tubular portion (46). In particular, the intraurethral prosthesis (1') according to claim 1 is provided with an intermediate portion (3) configured to be liquid-tightly connected to both the proximal connection end (29) and the distal connection end (31).

7. Either the proximal part (2) or the distal part (4) is a single part (2, 4) of an assigned length (L ２ , L ４ ), and the other part (4, 2) of either the distal or proximal is provided as a range of two or more parts of a different length (L ４ , L ２ ), each being configured to be selectively assembled with the proximal part or the distal part (2, 4) provided as a single specimen of an assigned length (L ２ , L ４ ), thereby creating the urethral prosthesis (1) of two or more overall lengths (L １ ) to select the most appropriate one for the patient's urethra. The urethral prosthesis (1') according to claim 6.

8. The distal portion (4) has a different length (L ４ The distal tubular portion (46) is provided as the range of two or more parts of the ), and the allocated length (L ３５ The first distal tubular element (35) of ) and a different length (L ４５ The urethral prosthesis according to claim 7, comprising: a second distal tubular element (45) provided as the range of two or more elements of; the second distal tubular element (45) having the distal connecting end (31); the first distal tubular element (35) and the second distal tubular element (45) having their respective mutually liquid-tight connecting ends (37, 44); and the second distal tubular element (45) forming the intermediate portion (3) of the urethral prosthesis (1).

9. The proximal portion (2) has a different length (L ２ The proximal tubular portion (24) is provided as the range of two or more parts of the ), and the allocated length (L ２５ The first proximal tubular element (25) of ) and a different length (L ３４ The urethral prosthesis according to claim 7, comprising: a second proximal tubular element (34) provided as the range of two or more elements of; the second proximal tubular element (34) having the proximal connecting end (29); the first proximal tubular element (25) and the second proximal tubular element (34) each having mutually liquid-tight connecting ends (28, 33); and the second proximal tubular element (34) forming the intermediate portion (3) of the urethral prosthesis (1).

10. The intraurethral prosthesis according to claim 1, wherein the stopper portion (156, 256) has a dome shape in which the through-slit (157, 257) converges to the central region (158, 258) of the stopper portion (156, 256).

11. The two annular sealing elements (32) protrude from the outer surface of the intermediate portion (3), In particular, the intraurethral prosthesis according to claim 8 or 9, wherein the annular sealing element (32) is positioned at the connecting ends (31, 44; 33, 29) of the intermediate portion (3).

12. The intermediate portion (3) of the urethral prosthesis (1) is axially flexible, that is, - From a linear configuration in which the distal portion (4) is aligned with the proximal portion (2), - The intraurethral prosthesis according to claim 8 or 9, wherein the proximal portion (2) and the distal portion (4) are configured to move into a flexed form connected by the elbow portion (3).

13. The urethral prosthesis according to claim 12, wherein the intermediate portion (3) is at least partially made of a biocompatible flexible polymer material (36), more specifically, medical-grade silicone.

14. The intermediate portion (3) of the urethral prosthesis (1) is - Two rigid connection ends (30, 40), - The proximal portion (2) and the first distal tubular element (35), or - Two rigid connecting ends (30, 40) for connecting the first proximal tubular element (25) and the distal portion (4), - A urethral prosthesis according to claim 8 or 9, comprising an axially flexible central tubular portion 36 made of a polymer material having a predetermined modulus of elasticity.

15. The urethral prosthesis according to claim 14, wherein the two rigid connecting ends (30, 40) each have cylindrical extensions (30', 40') formed within the thickness of the axially flexible central tubular portion (36).

16. The intraurethral prosthesis according to claim 14, wherein the cylindrical extensions (30', 40') have grip-reinforcing through holes (39) for the axially flexible central tubular portion (36) material.

17. The intraurethral prosthesis according to claim 1, wherein the valve element is a proximal valve element (150, 250), and the distal valve element (50') is disposed distal to the proximal valve element (150, 250) in a liquid-tight manner within the longitudinal duct (5).

18. The intraurethral prosthesis according to claim 17, wherein the proximal valve elements (150, 250) have a re-closing pressure higher than the opening pressure of the distal valve element (50'), thereby removing the urine (99) from the portion (41) of the longitudinal tube (5) between the proximal valve elements (150, 250) and the distal valve element (50') after the urine (99) has been discharged.

19. The urethral prosthesis (1) that comes into contact with the patient's tissue during use is further coated with a biocompatible material, the biocompatible coating material is - Hydrophilic medical-grade silicone, - Selected from the group consisting of amphoteric polymers, polyethylene glycol, and combinations thereof, a hydrogel having antifouling and antibacterial properties, In particular, the intraurethral prosthesis according to claim 1, wherein the hydrogel is combined with polydopamine to improve the long-term adhesion of the hydrogel to the surface.

20. A kit for an intraurethral prosthesis (1), comprising a proximal portion (2) and a distal portion (4) for the intraurethral prosthesis (1), The proximal portion (2) is, - A proximal tubular portion (24) configured to be positioned within the patient's urethra (7), and - A proximal stent (21) is provided, which is configured to be reversibly fixed to the inner wall (8) of the urethral-bladder lumen (6-7), The distal portion (4) is - A distal tubular portion (46) configured to be positioned within the urethra (7), and - A distal stent (49) is provided, configured to be reversibly fixed to the inner wall (8) of the urethra (7), The proximal tubular portion (24) and the distal tubular portion (46) have a predetermined radial rigidity. The proximal tubular portion (24) and the distal tubular portion (46) each have a proximal connecting end (29) and a distal connecting end (31) on opposite sides of the proximal stent and the distal stent (21, 49), respectively, which are liquid-tightly connected to each other and configured to connect the proximal portion (2) and the distal portion (4). To define a single longitudinal duct (5) arranged to transport urine (99), the longitudinal duct consists of a proximal tubular portion (24) and a distal tubular portion (46), Either the proximal portion (2) or the distal portion (4) has an assigned length (L ２ , L ４ ) is a single part (2, 4), and the other part (4, 2), either distal or proximal, is of a different length (L ４ , L ２ It is provided as a range of two or more parts of ) and each has an assigned length (L ２ , L ４ It is configured to be selectively assembled with the proximal or distal portion (2, 4) provided as a single specimen, thereby allowing for the selection of the most appropriate length (L) for the patient's urethra. １ A kit for producing the aforementioned urethral prosthesis (1).

21. The distal portion (4) has a different length (L ４ The distal tubular portion (46) is provided as the range of two or more parts of the ), and the allocated length (L ３５ The first distal tubular element (35) of ) and a different length (L ４５ The kit according to claim 20, comprising: a second distal tubular element (45) provided as the range of two or more elements of; the second distal tubular element (45) having the distal connecting end (31); the first distal tubular element (35) and the second distal tubular element (45) each having mutually liquid-tight connecting ends (37, 44); and the second distal tubular element (45) forming the intermediate portion (3) of the urethral prosthesis (1).

22. The proximal portion (2) has a different length (L ２ The proximal tubular portion (24) is provided as the range of two or more parts of the ), and the allocated length (L ２５ The first proximal tubular element (25) of ) and a different length (L ３４ The kit according to claim 20, wherein the first proximal tubular element (25) and the second proximal tubular element (34) are divided into two or more elements of the first proximal tubular element (25) and the second proximal tubular element (34), the second proximal tubular element (34) having the proximal connecting end (29), the first proximal tubular element (25) and the second proximal tubular element (34) each having mutually liquid-tight connecting ends (28, 33), and the second proximal tubular element (34) forms the intermediate portion (3) of the urethral prosthesis (1).

23. The valve elements (50, 150, 250) are liquid-tightly arranged within at least one portion selected between the proximal tubular portion (24) and the distal tubular portion (46), and the valve elements (50, 150, 250) include stopper portions (56, 156, 256), the stopper portions (56, 156, 256) are provided with elastic walls (55, 155, 255), and the differential pressure (ΔP) acting on the elastic walls (55, 155, 255) is such that the valve elements (50, 150, 250) have a predetermined opening pressure (P ＊ ) If it exceeds this, - From the deactivation and closure configuration of the valve elements (50, 150, 250) such that the urine (99) cannot flow through the longitudinal duct (5), - The valve elements (50, 150, 250) are configured to be deformed into a forced-open configuration so that the urine (99) can flow through the longitudinal duct (5). As a result, the patient can change the configuration of the valve elements (50, 150, 250) from the closed configuration to the open configuration by increasing his own abdominal pressure, according to the kit of claim 20.

24. The elastic walls (55, 155, 255) of the stopper portion (56, 156, 256) are separated from each other by a plurality of through slits (57). - In the closed configuration, the stopper portions (56, 156, 256) have a shape selected from a flat shape and a convex shape having a convex surface oriented toward the proximal stent (21), such that the pressure of urine acting on the stopper portions (56, 156, 256) keeps the through-slits (57, 157, 257) closed. - In the open configuration, the stopper portions (56, 156, 256) have a concave shape opposite to the convex shape, and the through slits (57, 157, 257) are configured to deform and open, allowing the flow of urine (99). In the closed configuration, the stopper portions (56, 156, 256) are such that the pressure of the urine is equal to the release pressure (P ＊ It is configured to withstand the pressure of the urine until it no longer exceeds the release pressure (P ＊ The kit according to claim 23, wherein when the limit is exceeded, the stopper portion (56, 156, 256) collapses into the concave shape.

25. The kit according to claim 24, wherein the stopper portion (56, 156, 256) has a dome shape in which the through slit (57, 157, 257) converges to the central region (58, 158, 258) of the stopper portion (56, 156, 256).

26. The valve element (150, 250) comprises an outer cylindrical montage portion (167, 267) that is liquid-tightly attached to the inner wall of at least one tubular portion (24, 46), The stopper portion (156, 256) of the valve element (150, 250) has a center point (159, 259) which is the center of the cylindrical montage portion (167, 267), and The kit according to claim 24, wherein the through slits (157, 257) converge to the same convergence point (158, 258) which is shifted by a predetermined distance (δ) from the center point (159, 259).

27. The stopper portion (156, 256) comprises an outer peripheral support disc (170, 270) whose elastic wall (155, 255) extends centripetically toward the center point (159, 259), The valve elements (150, 250) are provided with connecting portions (168, 268) between the outer peripheral support discs (170, 270) and the montage portions (167, 267), and The aforementioned outer peripheral support disks (170, 270) are - The outer peripheral support discs (170, 270) are concentric with respect to the outer peripheral cylindrical montage portion (167, 267), and the stopper portion is manufactured eccentrically with respect to the outer peripheral support discs (170, 270), - The kit according to claim 26, wherein the outer peripheral support discs (170, 270) are eccentric with respect to the outer peripheral cylindrical montage portion (167, 267), and the stopper portion is manufactured concentrically with respect to the outer peripheral support discs (170, 270), and the outer peripheral support discs (170, 270) are selected from among the above.

28. The kit according to claim 26, wherein the convergence point (158, 258) and the center point (159, 259) are at least 0.02 mm apart (δ).

29. The two annular sealing elements (32) protrude from the outer surface of the intermediate portion (3), In particular, the kit according to claim 21 or 22, wherein the annular sealing element (32) is positioned at the connecting ends (31, 44; 33, 29) of the intermediate portion (3).

30. The intermediate portion (3) of the urethral prosthesis (1) is axially flexible, that is, - From a linear configuration in which the distal portion (4) is aligned with the proximal portion (2), - The kit according to claim 21 or 22, wherein the proximal portion (2) and the distal portion (4) are configured to move into a flexed position connected by the elbow portion (3).

31. The kit according to claim 30, wherein the intermediate portion (3) is at least partially made of a biocompatible flexible polymer material (36), more specifically, medical-grade silicone.

32. The intermediate portion (3) of the urethral prosthesis (1) is - Two rigid connection ends (30, 40), - The proximal portion (2) and the first distal tubular element (35), or - Two rigid connecting ends (30, 40) for connecting the first proximal tubular element (25) and the distal portion (4), - The kit according to claim 21 or 22, comprising: an axially flexible central tubular portion 36 made of a polymer material having a predetermined modulus of elasticity.

33. The kit according to claim 32, wherein the two rigid connecting ends (30, 40) each have cylindrical extensions (30', 40') formed within the thickness of the axially flexible central tubular portion (36).

34. The kit according to claim 32, wherein the cylindrical extensions (30', 40') have grip-reinforcing through holes (39) for the material of the axially flexible central tubular portion (36).

35. The kit according to claim 23, wherein the valve elements are proximal valve elements (50, 150, 250), and the distal valve element (50') is liquid-tightly arranged distal to the proximal valve elements (50, 150, 250) within the longitudinal duct (5).

36. The kit according to claim 35, wherein the proximal valve elements (50, 150, 250) have a re-closing pressure higher than the opening pressure of the distal valve element (50'), thereby removing the urine (99) from the portion (41) of the longitudinal tube (5) between the proximal valve elements (50, 150, 250) and the distal valve element (50') after the urine (99) has been discharged.

37. The urethral prosthesis (1) that comes into contact with the patient's tissue during use further includes a coating of a biocompatible material on its surface, The aforementioned biocompatible coating material is - Hydrophilic medical-grade silicone, - Selected from the group consisting of amphoteric polymers, polyethylene glycol, and combinations thereof, a hydrogel having antifouling and antibacterial properties, In particular, the hydrogel is combined with polydopamine to improve the long-term adhesion of the hydrogel to the surface, according to claim 20.

Images