Urethral devices

Abstract

The intraurethral device comprises a valve configured to be actuated between an open configuration and a closed configuration by an external magnet, and a tube extending from the outlet port of the valve, the tube defining a passage for fluid flow, at least a portion of which is elliptical or amygdala-shaped.

Description

Technical Field

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[0001] Cross - Reference to Related Applications This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 460,167, filed Apr. 18, 2023, the content of which is hereby incorporated by reference in its entirety. Technical Field Embodiments relate to intraurethral devices and insertion systems for the placement of intraurethral devices.

Background Art

[0002] Background Generally, there is a need to provide an intraurethral device, such as a valve, that can selectively control the flow of fluid through the urethra. Such a device may be needed, for example, for patients with urinary incontinence or urinary retention. This includes patients with male urinary systems as well as patients with female urinary systems.

[0003] An example of the placement of such a valve in a male patient is shown in FIG. 1, which is an excerpt from FIG. 3 of Patent Document 1. In this specification, reference numerals that specifically refer only to the prior art figures (FIGS. 1 and 2) will be shown in parentheses (reference numerals will be used (without parentheses in this specification) to refer to FIGS. 3 - 15).

[0004] As understood, FIG. 1 shows a cross - section of a human male abdomen (30). The valve (1) is generally disposed within a bulge (17) within the patient's bulbar urethra (26) and is generally disposed upstream of the pendulous urethra (27) in terms of the normal flow of liquid through the urethra. The valve (1) is coupled to a retention mechanism by a catheter (16) that defines a lumen (21) having an outlet (25) at the valve (1) and an inlet defined by a retention loop (28) of the retention mechanism. The retention mechanism is disposed within the bladder (29) and includes a retention loop (28) that holds the retention mechanism in a predetermined position relative to the bladder neck (22).

[0005] Therefore, the operation of the valve (1) between the open and closed configurations is intended to control the flow of fluid from the bladder (29) through the outlet (25) to the hanging urethra 27.

[0006] A significant advance in this regard is the intraurethral magnetic valve described in Patent Document 2. Figure 1 of that document is reproduced as Figure 2 of this application for ease of reference. The document teaches an intraurethral magnetic valve (1) for insertion into the urethra of a person suffering from incontinence. The intraurethral magnetic valve (1) comprises a non-ferromagnetic cylindrical housing (2), a valve seat assembly (36) attached to one end of the housing, a spherical magnetic valve element (14) positioned for free movement within the housing, and a ring (10) attached to the other end of the housing for holding the valve element. The valve seat assembly (36) has a non-ferromagnetic valve seat (4) and a ferromagnetic ring (5). The valve element (14) is maintained in a closed checked position relative to the valve seat (4) by attraction to the ferromagnetic ring (5), thereby restricting the flow of fluid through the valve (1). An external magnet is used to impart magnetic torque and attractive force to the valve element (14), moving the valve element away from the valve seat (4) and opening the valve for fluid flow. With the removal of the external magnet, the valve element (14) returns to the closed checked position on the valve seat (4). The literature also teaches a second embodiment in which the intraurethral magnetic valve (1) includes a mechanism having a spring for releasing excess fluid pressure, and the valve seat assembly (36) is not mounted to the housing (2) but is axially slidable within the housing against the force of the spring when excess hydrostatic pressure is present, allowing the fluid to be released through a passage around the valve seat assembly (36).

[0007] Such advanced intraurethral magnetic valves attempt to enable the selective release of fluid from the bladder through the use of external magnets; in other words, magnets outside the patient's body are brought close to an internally mounted intraurethral magnetic valve, which can cause the valve to actuate from a closed configuration to an open configuration.

[0008] However, even with these urethral magnetic valves, problems exist. Some of these problems are particularly relevant to patients with female urinary tracts. In such urinary tracts, due to the short length of the urethra, the valve can be positioned practically at the urethral opening (such as the very end of the urethra). Therefore, there is a high risk of the valve migrating toward the bladder. Also, there is a high risk of infection if at least a portion of the valve extends out of the urethra or is positioned just inside the urethra.

[0009] The placement of intraurethral valves is also a subject of development. In particular, a system for placing intraurethral valves must allow the valve, catheter, and associated retaining mechanism to be pushed into place through the urethra. However, during placement in this manner, pulling and twisting of the valve, catheter, and their retaining mechanism are often required for accurate placement and advancement through the urethra. Typically, such placement systems require a part that is operated by a practitioner (surgeon or other medically qualified person), and therefore, that part does not enter the patient's urethra. All or part of this part of the placement system must be removable from the valve, catheter, and their retaining mechanism after the valve has been placed. Therefore, a placement system for intraurethral valve devices must be able to advance the valve, catheter, and their retaining mechanism into place through the urethra and be at least partially removable following such placement.

[0010] One such example is Patent Document 3, which teaches a system for implanting a catheter in the urethra. The system includes a catheter having a magnetic intraurethral valve positioned at one end of the catheter. The system also includes a tool having a tip member, the tip member extending into an opening at the first end of the catheter to connect the tool to the catheter. The system also includes an element extending from the tool. The catheter has an internal path that extends through the valve and provides a conduit for the element to engage with a second end of the catheter. The tool is adapted to apply stress to the catheter using the element, thereby hardening the catheter along its length. Hardening the catheter facilitates the implantation of the catheter into the urethra by allowing tensile, compressive, and torque forces.

[0011] Advances in the field of urethral valve arrangement can also be found in Patent Document 4. This document teaches an insertion facilitator for facilitating the insertion of a tubular structure into a passage in the body of a mammal. The device comprises (a) an elongated reinforcing member having a proximal end and a distal end, the reinforcing member extending from its distal end to its proximal end within the lumen of the tubular structure, the distal end of the reinforcing member being at least partially within the distal end of the tubular structure, and the proximal end of the reinforcing member being at least partially within the proximal end of the tubular structure, the reinforcing member providing greater rigidity to the tubular structure than in the absence of the reinforcing member, and being adapted to be axially displaced within the tubular structure, and (b) an engagement device, the reinforcing member and The device comprises an engagement mechanism that releasably engages with a tubular structure, the reinforcing member extending into the lumen of the tubular structure, and substantially eliminates one or both of the axial and radial displacement of the reinforcing member relative to the tubular structure during insertion of the tubular structure into an internal passage, and, in its released state, disengages the reinforcing member from the tubular structure, the reinforcing member being displaceable at least axially within the lumen of the tubular structure and can be withdrawn from the tubular structure, with at least the proximal end of the reinforcing member being positioned within or adjacent to the distal end of the tubular structure.

[0012] As can be understood from the aforementioned literature, these systems for the placement of intraurethral valves are relatively complex, and there is a general desire to simplify these systems.

[0013] Furthermore, in the female urinary tract, valves are often positioned near or at the urethral opening. Therefore, compared to their placement in the male urinary tract, the distance from the end of the valve closest to the urethral opening to the urethral opening is much shorter, meaning that placement tools can be specifically developed without the need to design such tools for advancement through a considerable length of the urethra (as is the case with many male urethral valve systems).

[0014] These and other issues were addressed in the advanced progress described in Patent Document 5. [Prior art documents] [Patent Documents]

[0015] [Patent Document 1] U.S. Patent No. 6066088 [Patent Document 2] International Publication No. 00 / 02499 [Patent Document 3] International Publication No. 2008 / 067557 [Patent Document 4] International Publication No. 2011 / 032150 [Patent Document 5] International Publication No. 2020 / 089623 [Overview of the project] [Problems that the invention aims to solve]

[0016] However, despite these advances, the need for further progress and improved solutions to these and other problems related to intraurethral devices such as valve devices remains. [Means for solving the problem]

[0017] Abstract One aspect provides an intraurethral device including a valve configured to be actuated between an open configuration and a closed configuration by an external magnet, and a tube extending from an outlet port of the valve, the tube defining a passageway for fluid flow, at least a portion of the passageway being elliptical or tonsil-shaped.

[0018] The device may further include a flange attached to the tube and configured to inhibit movement of the device.

[0019] The flange may have a generally circular outer shape.

[0020] At its distal end, the passageway may be circular.

[0021] The tube may extend over at least a portion of the valve.

[0022] The tube may include an outer shape that tapers between the valve and the distal end of the passageway.

[0023] The tube may be flexible.

[0024] Another aspect provides an intraurethral device including a valve configured to be actuated between an open configuration and a closed configuration by an external magnet, a catheter fluidly coupled to the valve, the actuation of the valve controlling the flow of fluid through the catheter, a retention mechanism coupled to the catheter and configured to deploy within the bladder, and an end piece including an attachment element, the end piece being configured to attach to a corresponding element of another portion of the device facing the retention mechanism, the length of the device being defined between the retention mechanism and the end piece, the attachment element being configured to removably attach to another portion of the device.

[0025] The mounting element and the corresponding element may be correspondingly threaded elements configured to engage with each other.

[0026] The mounting element and corresponding element may form a twist-lock mounting configuration.

[0027] The mounting element may include a head portion configured to pass through an opening defined by a corresponding element, and the head portion may be configured to rotate to contact a contact portion of the corresponding element.

[0028] The corresponding element may include a frame that defines the opening.

[0029] The frame may define a generally semicircular opening or a generally rectangular opening.

[0030] The frame may include at least one string-shaped beam.

[0031] The frame may include two string-shaped beams.

[0032] The contact portion and the head portion may include corresponding engagement structures, which may be configured to restrict the rotation of the contact portion and the head portion relative to each other when engaged.

[0033] The engaging structure may include at least one projection and one recess.

[0034] The mounting element may be configured to rotate about an axis relative to the corresponding element.

[0035] The mounting element and corresponding element may include a passage through which fluid can flow from the valve through the end piece.

[0036] Another embodiment provides an intraurethral device comprising a valve configured to be actuated between an open configuration and a closed configuration by an external magnet, and a corresponding element coupled to the valve, the corresponding element being configured to be detachably mounted to other parts of the device or other elements in a twist-lock mounting arrangement by engagement of the corresponding element with other parts of the device or other elements.

[0037] The corresponding element may define an opening configured to receive the head portion of the mounting element, the head portion passing through the opening, and the corresponding element may have a contact portion configured to contact the head portion following rotation of the head portion relative to the corresponding element.

[0038] The corresponding element may include a frame that defines the opening.

[0039] The frame may define a generally semicircular opening or a generally rectangular opening.

[0040] The frame may include at least one string-shaped beam.

[0041] The frame may include two string-shaped beams.

[0042] The contact portion and the head portion may include corresponding engagement structures, which may be configured to restrict the rotation of the contact portion and the head portion relative to each other when engaged.

[0043] The engaging structure may include at least one projection and one recess.

[0044] The mounting element may be configured to rotate about an axis relative to the corresponding element.

[0045] The mounting element and corresponding element may include a passage through which fluid can flow from the valve through the end piece.

[0046] Another embodiment provides an insertion system for an intraurethral device, the insertion system comprising an insertion tube configured to at least partially receive an intraurethral device, and a plunger member configured to at least partially receive the insertion tube, wherein the movement of the plunger member through the insertion tube pushes the intraurethral device out of the insertion tube.

[0047] The insertion system may further include an intraurethral device, the intraurethral device may include a valve configured to be actuated between an open configuration and a closed configuration by an external magnet, and a catheter coupled to the valve in fluid communication, wherein the actuation of the valve controls the flow of fluid through the catheter, and optionally the intraurethral device is the device described above.

[0048] The intraurethral device may be used in conjunction with the insertion system described above, and the device includes a valve configured to be actuated between an open configuration and a closed configuration by an external magnet, and a corresponding element coupled to the valve, the corresponding element being removablely attached to other parts of the device or other elements in a twist-lock mounting arrangement by engagement of the corresponding element with other parts of the device or other elements, and the plunger member includes a mounting element.

[0049] The features and advantages of the claimed subject matter will become apparent from the following detailed description of embodiments relating thereto, which should be considered with reference to the attached drawings. [Brief explanation of the drawing]

[0050] [Figure 1] This is a diagram extracted from Patent Document 2. [Figure 2] This is a diagram extracted from Patent Document 1. [Figure 3] This figure shows a conventional intraurethral device. [Figure 4] This is a diagram showing a conventional valve. [Figure 5] This is a diagram showing a conventional valve. [Figure 6] This is a diagram showing an example of a closing member. [Figure 7] This is a diagram showing an example of a closing member. [Figure 8] This is a diagram showing an example of a closing member. [Figure 9] This is a diagram showing an example of a closing member. [Figure 10] This is a diagram showing an example of a closing member. [Figure 11] This is a diagram showing an example of a closing member. [Figure 12] This diagram shows three versions of the device with different folding mechanisms. [Figure 13] This is a diagram showing the portion of the end pieces. [Figure 14] This is a diagram showing the portion of the end pieces. [Figure 15] This is a diagram showing the portion of the end pieces. [Figure 16] This is a diagram showing the portion of the end pieces. [Figure 17] This is a diagram showing the portion of the end pieces. [Figure 18] This is a diagram showing the portion of the end pieces. [Figure 19] This figure shows several versions of the insertion system. [Figure 20] This figure shows several versions of the insertion system. [Figure 21] This figure shows several versions of the insertion system. [Figure 22] This diagram shows the corresponding elements for several versions of the mounting element. [Figure 23] This diagram shows the corresponding elements for several versions of the mounting element. [Figure 24] This diagram shows the corresponding elements for several versions of the mounting element. [Figure 25] This diagram shows the corresponding elements for several versions of the mounting element. [Figure 26]This diagram shows the corresponding elements for several versions of the mounting element. [Figure 27] This diagram shows the corresponding elements for several versions of the mounting element. [Figure 28] This diagram shows the corresponding elements for several versions of the mounting element. [Figure 29] This diagram shows the corresponding elements for several versions of the mounting element. [Figure 30] This diagram shows the corresponding elements for several versions of the mounting element. [Figure 31] This diagram shows the corresponding elements for several versions of the mounting element. [Figure 32] This diagram shows the corresponding elements for several versions of the mounting element. [Modes for carrying out the invention]

[0051] For a complete understanding of this disclosure, references should be made to the following detailed description, including the accompanying claims and relating to the drawings described above. While this disclosure is described in relation to exemplary embodiments, the disclosure is not intended to be limited to any particular form described herein. It should be understood that various omissions and substitutions of equivalents will be considered where circumstances suggest or would be advantageous.

[0052] Detailed explanation In general, the present invention is directed toward intraurethral devices equipped with a unique valve. Various versions of intraurethral devices are shown and referenced in Figures 3-31 of this application (specifically, device 1 including valve 11). Valve 11 may be a magnetically actuated valve 11 for intraurethral placement. Thus, valve 11 may be an intraurethral magnetic valve 11.

[0053] For example, referring to Figures 4 and 5 (which are depictions of prior art valves from Patent Document 5, the contents of which are incorporated by reference), the valve 11 may include a valve body 111 in which a spherical magnetic valve element 112 (hereinafter, "valve element 112") defines an internal valve volume in which an internal valve volume is located. The internal valve volume has a length along the longitudinal axis of the valve body 111. The longitudinal axis of the valve body 111 extends from the inlet port 113 of the valve 11 to the outlet port 114 of the valve 11. The internal valve volume has a width along an axis perpendicular to the longitudinal axis of the valve body 111.

[0054] Both the inlet port 113 and the outlet port 114 may have a width (e.g., diameter) smaller than the width (e.g., diameter) of the internal valve volume.

[0055] The internal valve volume is sized to accommodate the valve element 112, for example, as shown in Figures 3 and 4. The internal valve volume may be sized to allow movement of the valve element 112 between a closed configuration and an open configuration, as described herein.

[0056] A ferromagnetic member 115, which may be a ring, is located toward the outlet port 114. The ferromagnetic member 115 defines a passage through which the fluid can pass. The ferromagnetic member 115 is shown inside the valve 11 in Figure 3.

[0057] The ferromagnetic member 115 may be a continuous ring of ferromagnetic material. Therefore, the ferromagnetic member 115 may generally be tubular in shape. In some versions, the ferromagnetic member 115 may be ring-like in that a complete ring cannot be formed by the ferromagnetic material, and the ferromagnetic material may form a ring-like structure formed from multiple ferromagnetic material segments.

[0058] The ferromagnetic member 115 may have a first end that faces the internal volume when inside the valve 11, and a second end that moves away from the internal volume (relative to the first end) when inside the valve 11. The first and second ends of the ferromagnetic member 115 may face each other across the length of the ferromagnetic member 115 (a length that may be parallel to the longitudinal axis of the valve 11 when the ferromagnetic member 115 is positioned inside the valve 11).

[0059] The ferromagnetic member 115 can be coupled to the valve body 111, which can be achieved in several different ways.

[0060] In some versions, the valve body 111 is formed from an elastomer material, or may be formed solely from an elastomer material. This elastomer material may be selected for its biocompatibility and / or its ability to impregnate the material with antimicrobial and / or antifungal agents. The ferromagnetic member 115 may be formed from an iron metal or an iron metal alloy. Therefore, the valve body 111 may be formed from a material that is relatively more flexible than the ferromagnetic member 115. In some versions, the application of force to the valve body 111 may result in the valve body 111 being elastically deformed, and the width of the internal valve volume (in the direction of the force) being reduced. In other words, the valve body 111 may be resilient to the compressive forces it may be subjected to.

[0061] In some versions, the ferromagnetic member 115 may be embedded in at least a portion of the valve body 111, and the valve body 111 may be formed at least partially around the ferromagnetic member 115. In such versions, the formation of the valve body 111 (or at least the portion in which the ferromagnetic member 115 is embedded) may be a molding process around the ferromagnetic member 115, and thus the ferromagnetic member 115 may be placed in the mold before the elastomer material for the valve body 111 (or a portion thereof) is fed into the mold (e.g., injected into the mold).

[0062] In some versions, the ferromagnetic member 115 can be fixed within the valve body 111 by interference fit. In such versions, the valve body 111 may be formed separately from the ferromagnetic member 115, and a recess for housing the ferromagnetic member 115 is defined by the valve body 111. The ferromagnetic member 115 is then inserted into the recess and can be held in place by interference fit between, for example, the valve body 111 and one or more surfaces of the ferromagnetic member 115. In some versions, a material plug (which may be an elastomer material, such as the one used for the valve body 111) may be used to fix or assist in fixing the ferromagnetic member 115 in place. This plug may be positioned toward, and in fact may define, the outlet port 114 of the valve 11, and the plug may be, for example, annular in shape, and the outlet port 114 is defined by the plug.

[0063] In some versions, the ferromagnetic member 115 may be fitted into a spigot member of the valve body 111. The spigot member may define a passage through which the ferromagnetic member 115 can slide in place on the spigot member. A plug of material may then be attached to the ferromagnetic member 115. The plug of material may generally be annular in shape.

[0064] In some versions, an adhesive may be used to fix the ferromagnetic member 115 to the valve body 111, or to assist in its fixation. In some versions, it will be understood that the spigot member may be part of the valve body 111, and similarly, the material plug may form part of the valve body 111.

[0065] In some versions, the valve body 111 may be tubular in shape, having one open end and a ferromagnetic member 115 positioned at the opposite end (the opposite end forming an outlet, which may generally be narrower than the open end). The open end may be configured to be attached to another part of the valve body 111 and / or the end of the catheter 12, the other part defining an inlet port 113, or the outlet of the catheter 12 forming an inlet port 113 for the valve 11. Thus, the valve element 112 may be positioned within the valve body 111 via its open end before the valve body 111 is coupled to the other part of the valve body 111 and / or the end of the catheter 12 (the other part of the valve body 111 may be coupled to the catheter 12). The catheter 12 may be formed integrally with at least a portion of the valve 11 (e.g., the valve body 111), or bonded thereto, or connected using a coupling process (e.g., insert molding).

[0066] In some versions, where the valve body 111 is not molded around the ferromagnetic member 115 during manufacturing, the valve element 112 may be inserted through the outlet port 114 (or the end of the valve body 111 where the outlet port 114 will be located) before the insertion of the ferromagnetic member 115 (and, for example, the plug). The elastomer material of the valve body 111 may be configured to be elastically deformable, for example, in this way to allow the insertion of the valve element 112.

[0067] The valve 11 includes a valve seat 116, which may be, for example, a non-ferromagnetic valve seat 116. The valve seat 116 may be formed in various ways depending on the version. For example, in some versions, the valve seat 116 may be formed from the same material that forms the valve body 111 on which the ferromagnetic member 115 is located.

[0068] The portion of the valve seat 116 configured to contact the valve element 112 may have a radius that is in harmony with, or substantially in harmony with, the outer radius of the valve element 112. In some versions, the portion of the valve seat 116 configured to contact the valve element 112 may be configured to deform elastically upon contact with the valve element 112. Such an arrangement may be configured to improve the sealing performance between the valve seat 116 and the valve element 112.

[0069] In some versions, a separate ferromagnetic member 115 is not used. For example, the valve seat 116 may be formed from small steel or an elastomer (e.g., silicon) containing fillers such as iron balls or powder. In some versions, the ferromagnetic member 115 is provided as a separate component from the valve seat 116, but the valve seat 116 itself is formed from small steel or an elastomer (e.g., silicon) containing fillers such as iron balls or powder.

[0070] Therefore, in some versions, the end face at the first end of the ferromagnetic member 115 may be covered by the material forming the valve body 111.

[0071] In some versions, the material of the valve body 111 covers the end face at the first end of the ferromagnetic ring 5, but in this version and several other versions, at least a portion of the passage through the valve 11 is defined by the ferromagnetic ring 5, and the fluid passing through it may come into contact with, for example, the ferromagnetic ring 5 (or at least a portion thereof). In these versions, the valve seat 116 may be formed of the material covering the end face at the first end of the ferromagnetic ring 5.

[0072] In some versions, as shown in Figure 5, for example, the material of the valve body 111 covers the end face of the first end of the ferromagnetic member 115, but the rest of the ferromagnetic member 115 is also substantially covered by the material of the valve body 111, so that the fluid passing through it does not come into contact with the ferromagnetic member 115 (or at least not with its main part). In these versions, the valve seat 116 may be formed from the material covering the end face of the first end of the ferromagnetic member 115.

[0073] In some versions, a separate valve seat member is provided to form the valve seat 116. This separate valve seat member may be positioned adjacent to the end face at the first end of the ferromagnetic member 115, fixed to the ferromagnetic member 115, and / or at least partially embedded in the material of the valve body 111. The valve seat member may be formed of an elastomer material that is harder than the valve body 111, or may have one or more properties that enhance the sealing performance between the valve element 112 and the valve seat 116 (compared to using the material of the valve body 111 as the valve seat 116). In some versions, the valve seat member may improve the consistency of the formation of the valve seat 116 (again, compared to using the material of the valve body 111 as the valve seat 116). The valve seat member may be formed of silicon with a different durometer than the valve body 111 (the valve body 111 may also be formed of silicon).

[0074] Device 1 (for example, using valve 11) can be operated between an open configuration and a closed configuration (for example, by the use of an external magnet, the external magnet being outside device 1 and, if attached, outside the body of the person to whom device 1 is attached). In the open configuration, the valve element 112 is separated from the valve seat 116, and the fluid flows around the valve element 112 and through the outlet port 114. In the closed configuration, the valve element 112 is seated on the valve seat 116, and the outlet port 114 is substantially sealed or sealed from fluid communication with the inlet port 113.

[0075] As can be understood, the valve element 112 can be biased toward a closed configuration by magnetic attraction to the ferromagnetic member 115. Furthermore, with the device 1 (e.g., valve 11) positioned in the urethra as an intraurethral device (e.g., valve) and oriented toward the normal flow of fluid passing through it, the inlet port 113 may be upstream of the outlet port 114 with respect to the fluid, and consequently, the fluid flow through the valve 11 may also help bias the valve element 112 toward a closed configuration.

[0076] The operation of valve 11 to the open configuration can be achieved through the use of a magnetic member. The magnetic member is located outside the patient to which valve 11 is installed and is moved to a relatively close position to valve 11 in order to achieve operation from the closed configuration to the open configuration (due to the exposure of the magnetic member of valve 11 to a magnetic field, the magnetic field being strong enough to achieve operation).

[0077] Actuation to the closed configuration can be achieved by the magnetic attraction between the valve element 112 and the ferromagnetic ring 115, and may be assisted, for example, by gravity and / or the fluid flow through the valve 11.

[0078] The valve 11 described herein may be fitted to a male or female patient as an intraurethral magnetic valve 11. Referring to Figure 1, the valve 11 described herein may be used in place of valve (1) shown in Figure 1 and described in the reference from which the figure is cited, for further details of the reference.

[0079] As described above, the valve 11 may be coupled to the catheter 12. The catheter 12 provides and defines a fluid passage to the valve 11, particularly to the inlet port 113 of the valve 11. The valve 11 may be an intraurethral valve 11, and the catheter 12 may be coupled to a retaining mechanism 14 configured to fix the valve 11 and the catheter 12 in a desired position or to assist in fixing them. Some versions do not include the retaining mechanism 14 and may be held in place by the action of the catheter 12 and / or valve 11 on the urethra.

[0080] The retaining mechanism 14 may take various forms and is configured to pass through the urethra to a desired position before being deployed. Deployment helps the retaining mechanism 14 hold the catheter 12 and / or valve 11 in place. In some cases, deployment generally means the expansion or extension of at least a portion of the retaining mechanism 14.

[0081] In some versions, the retaining mechanism 14 may include a Malcott, as shown in Figures 3 and 12. The retaining mechanism 14 may include a plurality of arms, loops, or rings that, when deployed, function to restrict the movement of the catheter 12 and / or valve 11 coupled to the retaining mechanism 14. Thus, the arms, loops, or rings are movable from a non-deployed or retracted configuration to a deployed or extended configuration. Here, arms, loops, or rings are examples of deployable members of the retaining mechanism 14, and this term will be used hereafter.

[0082] Therefore, in some versions, device 1 is provided that includes a valve 11, a catheter 12, and a retention mechanism 14.

[0083] The length of the catheter 12 from the valve 11 to the retaining mechanism 14 can be selected based on a desired arrangement of the valve 11, for example, as described herein.

[0084] The retaining mechanism 14 may include a plurality of deployable members, as described above. These deployable members may extend radially outward from the catheter 12, and when deployed, they define a portion of the device 1 that is wider than the catheter 12 (however, in the non-deployed configuration, they may be retracted, for example, substantially the same width as the catheter 12). The deployable members may define spaces between them. These spaces may provide fluid communication between the volume surrounding the retaining mechanism and the lumen defined by the catheter 12. In the case of an intraurethral system, this volume may be the bladder.

[0085] Therefore, as in Figure 1, the holding mechanism 14 may be located in the bladder neck, and the catheter 12 extends downward through the urethra (in terms of the normal direction of fluid flow).

[0086] Several versions of the valve 11 may be inserted or embedded using, for example, the systems disclosed in Patent Document 2 and / or Patent Document 4 and / or Patent Document 5, the details of which are incorporated as a whole by reference.

[0087] Valve 11 may be, for example, a valve as described in Patent Document 2 and / or Patent Document 4 and / or Patent Document 5, the details thereof being incorporated as a whole by reference.

[0088] The magnetic members may be, for example, those described in Patent Document 2 and / or Patent Document 4 and / or Patent Document 5, and their details are incorporated as a whole by reference.

[0089] Therefore, when in use, device 1 can be positioned within the patient's bladder and urethra. In particular, the retaining mechanism 14 may be positioned within the bladder, the catheter 12 extending downward through the urethra, and the valve 11 positioned along the length of the catheter 12, or at the end of the catheter 12 furthest from the retaining mechanism 14 (in some versions, the length of the catheter 12 also extends from the outlet port 114 of the valve 11, and the valve 11 is positioned between the two opposing ends of the catheter 12).

[0090] urethral atresia Referring to Figures 6-11, in some versions, the outlet port 114 of the valve 11 may be in fluid communication with the urethral closure member 3 (which may be referred to herein, for example, as “closure member 3”).

[0091] The closing member 3 is connected to the outlet port 114 in fluid communication and may include a tube 31 configured such that, with the holding mechanism 14 positioned inside the bladder, the distal portion of the tube 31 of the closing member 3 can extend to the urethral opening and be positioned outside the urethra.

[0092] The distal portion of the tube 31 (the proximal portion is, for example, the portion connected to the valve 11) may be accompanied by a flange 32. The flange 32 may have an outer diameter larger than the outer diameter of the tube 31. The flange 32 may also, or alternatively, have an outer diameter larger than the outer diameter of the valve 11. The flange 32 may have an outer diameter sized to reduce the risk of the flange 32 moving beyond the urethral opening into the urethra.

[0093] In some versions, the tube 31 may be formed from the same material as the valve body 111 and / or catheter 12. In some versions, the tube 31 is formed integrally with the valve 11. In some versions, the tube 31 extends over the valve 11 (e.g., over the valve body 111) to cover the valve 11 (or at least a portion thereof). The tube 31 may be bonded or welded to the valve 11, for example.

[0094] In some versions, the flange 32 is formed integrally with the tube 31 (the tube 31 may be formed integrally with the valve 11 as described herein). In some versions, the flange 32 is formed from the same material as the tube 31. In some versions, the flange 32 is formed from a different material than the tube 31. In some versions, the flange 32 is formed from a harder material than the tube 31, which may help, for example, prevent the flange 32 from bending and entering the urethra. In some versions, the flange 32 is glued or welded to the tube 31. In some versions, the flange 32 is provided in the form of multiple parts, i.e., two annular parts. Multiple parts of such versions of the flange 32 may be configured to receive a portion of the tube 31 between them, and the joining of the two parts (e.g., by gluing, welding, or interference fit) may capture a portion of the tube 31 (e.g., its wall around it) to join the flange 32 to the tube 31. In some versions, part of the flange 32 is an annular or mushroom-shaped member defining an opening, another part of the flange 32 is a tubular insert configured to fit into the annular or mushroom-shaped member, and part of the tube 31 is sandwiched between them (adhesive or welding may also be used).

[0095] In some versions, tube 31 may have an inner diameter that defines a passage for the flow of urine passing through it (urine passing through valve 11 into tube 31).

[0096] The inner diameter may be substantially constant throughout the entire length of the tube 31 (see, for example, Figures 6 and 7). The outer diameter of the tube 31 may follow the inner diameter along the length of the tube 31. In some such versions, the outer diameter may be approximately the same as the outer diameter of the valve 11, and as a result, there is no substantial increase or decrease in the outer diameter of the device 1 between the valve 11 and the tube 31. In some versions, the flange 32 is provided by a mushroom-shaped member, and the neck portion 321 of the mushroom-shaped member is received inside the tube 31 (for example, it may be shaped and sized to be received in this way, and thus may have an outer diameter that is approximately the same as or slightly smaller than the inner diameter of the tube 31). The neck portion 321 may be bonded or welded to the tube 31 (for example, inside the tube 31).

[0097] The neck portion 321 extends beyond the tube 31 and can support a flange portion 322 having a larger outer diameter than the neck portion 321.

[0098] The tube 31 has an internal shape at its distal end (i.e., at the flange 32). This shape may be defined by the tube 31 itself or by a portion of the flange 32 that can hold the tube 31 in such a shape. In other versions, the flange 32 forms the distal end of the closure member 3. In either case, the tube 31 or the flange 32 forms the distal end of the closure member 3, and either may define the internal shape of the passage through which urine will pass. This may be referred to herein, for example, as the distal end shape of the passage.

[0099] The passage also has a shape along a portion of its length between its distal end and the valve 11, which may be referred to as the intermediate passage portion shape. This portion of the length may not include the distal end. The distal end of the passage may have a length of 2-30 mm (consequently, the intermediate passage portion may be located at this distance from the distal end of the tube 31 and / or flange 32 and / or closing member 3).

[0100] The distal end shape of the passage may be circular, elliptical, or amygdala-shaped (see Figures 10 and 11). The intermediate section shape of the passage may be circular, elliptical, or amygdala-shaped.

[0101] In some versions, the shape of the passages in these sections is such that they pass through the cross section of the closing member 3 perpendicular to its longitudinal axis (i.e., the cross section perpendicular to the direction of urine flow during normal use).

[0102] In some versions, the distal end shape of the passage extends (or alternatively, is provided) along the length of the tube 31 toward the valve 11 and away from the flange 32.

[0103] In some versions, the distal end shape of the passage is circular, and the middle section of the passage may be elliptical or amygdala-shaped.

[0104] Therefore, in some versions, at least part of the shape of the passage may be elliptical or amygdala-shaped.

[0105] In some versions, the external shape of tube 31 matches or corresponds to the internal shape of tube 31.

[0106] In some versions, the cross-sectional area of ​​the passage at the distal end, or toward the distal end, is smaller than the cross-sectional area at the proximal end (i.e., the end adjacent to the valve 11). In some versions, the passage has its smallest cross-sectional area at the point between the flange 32 and the valve 11 (see Figures 8-11). Thus, in some versions, the tube 31 may narrow along the length between the valve 11 and the flange 32, and then expand. This change in size may be a change in the internal cross-sectional area of ​​the passage and / or the external cross-sectional area of ​​the tube 31.

[0107] The passage at or toward the distal end of the tube 31 and / or flange 32 may be smaller than the outlet port 113 of the valve 11.

[0108] A smaller size of the passage at or toward the distal end of tube 31 and / or flange 32 may help reduce the risk of contaminants entering the passage and reaching valve 11 and / or catheter 12, for example. In versions with a tonsillar-shaped passage, this (if tube 31 is formed from a sufficiently flexible material) may be able to open or close at least partially with a decrease or increase in external force (e.g., muscle). This may help control urine and / or avoid contaminants. For example, the pressure of urine flowing through the passage may help open any blockage of the passage in this area.

[0109] The flange 32 is an example of a movement-preventing member, i.e., a member that prevents the device from moving into the bladder. Other forms of movement-preventing members may be positioned toward the end or end of the device 1 opposite the retaining mechanism 14 (which prevents the device 1 from moving out of the urethra through the urethral opening).

[0110] Size adjustment In the use of device 1 in the female urinary tract, the length of the urethra between the bladder and the urethral opening is more important than in the male urinary tract. This is because the retaining mechanism 14 is positioned in the bladder, and in some versions, an anti-movement member is positioned in the urethral opening. If device 1 is too long, it may protrude excessively and cause discomfort. If device 1 is too short, it may not fit properly or may be uncomfortable due to the pressure applied to the bladder by the retaining mechanism 14.

[0111] In some versions, the catheter 12 may include a foldable portion 4 (see Figure 12) along at least a portion of its length. The foldable portion 4 is configured to be folded to shorten the length of the device 1 or expanded to increase the length of the device 1. The foldable portion 4 may include one or more circumferential folds in the wall of the catheter 12 (for example, forming a concertina portion).

[0112] In some versions, there may be an end piece 5 (see Figures 13–18) configured to be attached to the end of device 1 that is positioned closest to the urethra when device 1 is installed. In some versions, this may be a valve 11. The end piece 5 may be configured to be interchangeably attached to that end of device 1, so that one end piece 5 can be removed and another end piece 5 can be attached. In some versions, that end of device 1 is configured to be connected to one of several different end pieces 5, each end piece 5 may be of a different size and / or shape. In the illustrated examples, Figures 13 and 14 show the shortest drawn end piece, and Figures 17 and 18 show the longest drawn end piece 5.

[0113] In some versions, the end of device 1 located closest to the urethral opening (e.g., the end of valve 11 with outlet port 114) may be provided with a threaded insert or a twistlock (e.g., bayonet) fitting. Thus, in some versions, the end piece 5 (which may be one of a number of end pieces 5, which may be of different sizes and / or shapes) may include a corresponding threaded member or a twistlock (e.g., bayonet) fastener, and as a result, the end piece 5 may be selectively attached to the end of device 1. Thus, the end piece 5 may include a mounting element 52 configured to engage with a corresponding part of device 1, which may be a part of device 1 (e.g., valve 11), and the threaded member and twistlock fastener are illustrative examples.

[0114] The end piece 5 may include a flange 51 configured to function as an anti-movement member, and the flange 51 may be round, oval, or other shape to fit the body adjacent to the urethral opening. In some versions, the flange 51 may be configured to be cut to allow for customization of the shape for comfort (i.e., the flange 51 may be formed from a material that can be made to a certain size by hand using scissors or a knife). In some versions, the flange 51 may be molded so that a custom mold is made for a particular patient and the flange 51 is manufactured according to that mold.

[0115] The flange 51 of the end piece 5 defines an opening through which urine passes during use. The opening is connected to the mounting element 52 by a duct 53, which may be connected to the mounting element 52 and to the opening through the flange 51 for fluid communication. Thus, the mounting element 52 may also define a passage for fluid communication with the duct 53 and the opening in the flange 51. In some versions, urine can pass through the valve 11, through the mounting element 52 of the end piece 5, through the duct 53, and out through the opening defined by the flange 51 of the end piece 5.

[0116] The duct 53 may taper towards the mounting element 52.

[0117] In some versions, multiple different end pieces 5 may be provided, which may have different lengths for the duct 53. The selection of different end pieces 5 allows for different lengths of the device 1 to be realized. Thus, the device 1 can be customized to fit a particular woman's urinary tract.

[0118] In some cases, the end piece 5 may be configured to be replaced in situ (i.e., while device 1 is in place within the patient). Periodic replacement of the end piece 5 (which may be replacement with the same end piece 5) would help prevent contaminants that could cause infections.

[0119] Insertion In some versions, an insertion system 2 is provided, configured for use in inserting device 1 into the urethra (see, for example, Figures 19–21). The insertion system 2 may include an insertion tube 21 configured into which device 1 is fitted, and a retaining mechanism 14 is located within the insertion tube 21. In some versions, the end of the retaining mechanism 14 may extend from the open end of the insertion tube 21 with device 1 housed in the insertion tube 21, but the retaining mechanism 14 may be in a folded state and may be held in that state by the insertion tube 21 (this may limit the expansion of the retaining mechanism 14).

[0120] Therefore, device 1 is provided at least partially within the insertion tube 21, which can be inserted into the urethra. The insertion tube 21 may have a circular outer cross-section and may be generally smooth, which may facilitate insertion of the tube 21 into the urethra (compared, for example, to attempting to insert device 1 into the urethra). This may be particularly useful in examples where a sealing member is provided around at least a portion of device 1.

[0121] The insertion system 2 may include a plunger member 22 configured to be at least partially received by the insertion tube 21. The plunger member 22 may include an engaging end configured to engage with the device 1. Thus, the engaging end may include a portion configured to be at least partially received by a valve 11 or a portion of the catheter 12. In some versions, the engaging end may include a portion configured to at least partially receive a valve 11 or a portion of the catheter 12. The engaging end may engage with the device 1, and the movement of the plunger member 22 will result in the movement of the device 1. Thus, with the device 1 at least partially received by the insertion tube 21, the plunger member 22 may engage with the device 1 (a portion of the plunger member 22 extends from one end of the insertion tube 21), and the movement of the plunger member 22 through the insertion tube 21 may push the device 1 out from the opposite end of the insertion tube 21. Thus, the end of the plunger member 22 (which is opposite the engaging end) may include a plate configured to assist the user in manually pushing the plunger member 22. In some versions, the insertion tube 21 may include one or more (e.g., two) finger protrusions, and the user may use the fingers of one hand to hold the insertion tube 21 and press the plunger member 22 (e.g., with the thumb) in much the same way that a syringe is operated.

[0122] This insertion system 2 may provide a relatively simple system for inserting device 1. Insertion system 2 may be pre-lubricated, and the lubrication may include lubrication of both the inner and outer surfaces of the insertion tube 21, or lubrication of only one of these surfaces.

[0123] The insertion tube 21 can be a rigid member, or it can be more rigid than the device 1. Therefore, the insertion tube 21 can assist in the insertion of the device 1.

[0124] To be understood, the deployment of device 1 from the insertion system 2 involves pushing device 1 out of the insertion tube 21 (using the plunger member 22). Once the retaining mechanism 14 is released from its restraint on the insertion tube 21, the retaining mechanism 14 can expand or deploy (e.g., into the bladder). The plunger member 22 is then released from device 1 and removed from the urethra, leaving device 1 retained within the urethra (and bladder).

[0125] The engagement between the engaging end and device 1 may take various forms, including screw-in or twist-fit engagements (e.g., bayonet). In some versions, all that is provided between the engaging end and device 1 is a simple contact. In some versions, the engagement between the engaging end and device 1 uses the same part of the device used to connect the end piece 5 as described herein. Thus, in some versions, the engaging end may include the mounting element 52 as described herein.

[0126] Mounting elements Referring to Figures 12-18 as well as Figures 22-32, the use of mounting elements 52 is illustrated, for example, with respect to both the end piece 5 and the plunger member 22. Various different mounting elements 52 are possible. For example, a mounting element 52 may include a male threaded portion configured to engage with a female threaded portion of the valve 11 (or some other part of the device 1) (see Figures 12-18). The female threaded portion may be, for example, an insert that is embedded (e.g., overmolded) during the formation of the valve 11.

[0127] As described herein, twist-fit engagements are also possible in some versions (e.g., bayonet fittings).

[0128] Next, with reference to Figures 22-32, several exemplary twist-fit engagement mounting elements 52 and corresponding elements 117 of device 1 (e.g., valve 11) that correspond to the mounting elements 52 will be described.

[0129] In some versions, the mounting element 52 is pushed beyond the position of the corresponding element 117 and then rotated relative to the corresponding element 117 to lock the mounting element 52 to the corresponding element 117. Once locked together, axial movement of the mounting element 52 in at least one direction (both axial directions in some versions) will result in a corresponding movement of the corresponding element 117.

[0130] In some versions, the corresponding element 117 may define an opening 1171 configured to receive the head portion 521 through it. In some versions, the corresponding element 117 includes a frame 1172 that defines, if not completely, the opening 1171 through the corresponding element 117 at least partially. The corresponding element 117 may also include a contact portion 1173. In some versions, the contact portion 1173 may be part of the frame 1172 or may be coupled to the frame 1172 or other part of the valve 11.

[0131] The head portion 521 of the mounting element 52 may be configured to be received by an opening 1171 through the corresponding element 117 and then rotated around an axis (relative to the corresponding element 117), so that the head portion 521 (originally aligned with the opening 1171) aligns with a contact portion 1173, and the head portion 521 and the contact portion 1173 come into contact to prevent or block the removal of the mounting element 52 from the corresponding element 117. In such a configuration, axial movement of the mounting element 52 will result in axial movement (in the same direction) of the corresponding element 117 via the contact between the head portion 521 and the contact portion 1173. Thus, in such a configuration, the mounting element 52 and the corresponding element 117 are coupled (and therefore can generally be said to be coupled).

[0132] Rotation of the mounting element 52 around the axis of the corresponding element 117 to reposition the head portion 521 with respect to the opening 1171 of the corresponding element 117 then allows the head portion 521 to pass through the opening 1171 and the mounting element 52 can be detached. This allows one or more elements coupled to the device 1 through the use of the mounting element 52 and the corresponding element 117 to be removed from the device, which may include, for example, the removal of a part of device 1 from another part of device 1.

[0133] The head portion 521 of the mounting element 52 and the corresponding element 117 may take on a number of different forms.

[0134] In some examples (see, for example, Figures 22–25), the mounting element 52 includes a shaft 522 and a head portion 521. The head portion 521 may be in the shape of a member extending radially from the shaft 522. In some versions, the head portion 521 is semicircular (for example, the center of the circle is aligned with the central longitudinal axis of the shaft 522).

[0135] The corresponding element 117 may include a frame 1172 in the shape of an annular ring, having an inner diameter equal to or slightly larger than the outer diameter of the head portion 521, through which the head portion 521 can pass. The corresponding element 117 may include a contact portion 1173, which is substantially semicircular and may extend across about half of the opening defined by the frame 1172. Thus, the opening 1171 is defined by the frame 1172 and the contact portion 1173, and the opening 1171 is substantially semicircular. The contact portion 1173 may include a slot through which the shaft 522 passes, configured to receive at least a portion of the shaft 522, and the slot may be semicircular in shape. The slot may typically be located in the center of the opening in the frame 1172.

[0136] Therefore, in some such versions, the mounting element 52 may be presented to the corresponding element 117 with the head portion 521 and the opening 1171 substantially aligned. The head portion 521 may pass through the opening 1171 (the shaft 522 is at least partially received in the slot of the contact portion 1173). The mounting element 52 may then be rotated (for example, around the axis) relative to the corresponding element 117, and the head portion 521 moves to contact the contact portion 1173, in which position the head portion 521 is prevented from returning through the opening 1171.

[0137] In some versions, the contact portion 1173 and the head portion 521 may each be in the form of a part of a disk (i.e., having flat, opposing sides).

[0138] In some versions, the head portion 521 is provided with a hinge connecting it to the shaft 522, and the head portion 521 can rotate between a position in which it extends perpendicularly to the shaft 522 (as shown) and a position in which it folds adjacent to the shaft (not shown). This can, for example, assist in insertion.

[0139] In some versions, the contact portion 1172 and the head portion 521 include their respective engaging structures 1174, 5211. The engaging structures 1174, 5211 are configured to engage with each other to prevent rotation of the contact portion 1172 and the head portion 521 relative to each other when the two portions 1172, 521 are in contact with each other. In some versions, the engaging structures 1174, 5211 include, for example, corresponding projections and recesses that connect with each other. In some versions, the projections may be substantially circular, and the recesses may also be substantially circular. The engaging structures 1174, 5211 may be spaced apart from the axis of rotation of the mounting element 52 during use.

[0140] The mounting element 52 and / or the corresponding element 117 may be formed from a plastic material or steel (e.g., stainless steel).

[0141] As can be understood, this contact between the contact portion 1172 and the head portion 521 can restrict or prevent axial movement in one direction. Axial movement in the other direction can be blocked or substantially prevented by the contact of the head portion 521 with respect to a portion of the valve 11 adjacent to the contact portion 1172 (resulting in a channel for the head portion 521 being defined between the contact portion 1172 and the portion of the valve 11). Axial movement in the other direction can be blocked or substantially prevented by the contact between the mounting element 52 to which the mounting element 52 is attached or forms part thereof, and a portion of the valve 11 or another part of the device 1 (such elements may be, for example, the end piece 5, or, for example, the closing member 3, or, for example, the plunger member 22).

[0142] To ensure understanding, the roles of the mounting element 52 and the corresponding element 117 can be reversed (for example, the valve 11 may include the corresponding element 117 or be mounted on the corresponding element 117, while the mounting element 52 is part of another element (e.g., the end piece 5, the closing member 3, or the plunger member 22) or is mounted on another element).

[0143] In some versions, the head portion 521 may have a different shape from some of the versions described above (see, for example, Figures 26-29). For example, the head portion 521 may be roughly rectangular in shape (with its shorter side curved). The head portion 521 may be symmetrical in use (about the axis of rotation, i.e., the longitudinal axis of the shaft 522).

[0144] In some versions, the frame 1172 may be in the shape of an annular member with two chord-shaped beams positioned on either side of the center of the annular member and extending across the opening defined by the annular member. Thus, the two chord-shaped beams may define a gap between them (together with a portion of the annular member), in which the center of the opening is located, and this gap may provide the opening 1171 (for example, this gap may be the opening 1171). The head portion 521 may be shaped in correspondence with this gap (i.e., employing a circle sized to correspond with the opening defined by the annular member, where two chords of the circle are the two opposing edges of the head portion 521, and the other two opposing edges may be part of the circumference of the circle). The shaft 522 may extend from a central position relative to the head portion 521, as understood.

[0145] Therefore, the head portion 521 can be passed through the opening 1171 and then rotated as described above. The head portion 521 can then come into contact with the string beam, so that the string beam has a contact portion 1173 in such a version.

[0146] In some versions, the engagement structures 1174, 5211 may include one or more projections 5211 extending from each portion of the head portion 521 and abutting against the string beam or each edge of each string beam. Thus, in such versions, the string beam may also form an engagement structure, and in particular, the edges of the string beam may form an engagement structure.

[0147] In some versions, only one string-shaped beam may exist.

[0148] In some versions, the mounting element 52 may have a different shape (see, for example, Figures 30-32) and may include two or more protrusions (for example, protrusions extending radially from the element to which the mounting element 52 is attached, or from an element that forms part of the mounting element 52, or protrusions extending from the tubular body portion of the mounting element 52). These protrusions may be cylindrical. Each of these protrusions forms a head portion 521, and therefore, in some versions, there may be multiple head portions 521.

[0149] In some such versions, the corresponding element 117 includes a frame 1172 in the form of an annular member defining L-shaped slots around it. Each of these L-shaped slots may include an opening for receiving the respective projection of the mounting element 52. These L-shaped slots may define the respective channels from their openings passing through a bend (e.g., a 90-degree bend), and the axial movement of the mounting element 52 relative to the corresponding element 117 results in the acceptance of the projection of the mounting element 52 through the opening defined by the corresponding element 117. The mounting element 52 is then rotated about an axis relative to the corresponding element 117, and the projection can move along the respective channels within the corresponding element 117 and around the bend. In some such versions, the portion of the frame 1172 defining the L-shaped slots forms a contact portion 1173.

[0150] For ease of reference, the version of Device 1 is described in reference to the passage and flow of urine. As should be understood, other fluids may pass through Device 1, and therefore it is appropriate to refer to the flow and passage of fluids in general.

[0151] As used herein and in the claims, the terms “includes” and “contains” and their variations mean that the identified feature, step, or whole is included. The terms should not be construed to exclude the presence of other features, steps, or components.

[0152] The present invention may also broadly consist of parts, elements, steps, examples, and / or features individually referred to or shown herein, or collectively, any combination of two or more such parts, elements, steps, examples, and / or features. In particular, one or more features in any embodiment described herein may be combined with one or more features in any other embodiment described herein.

[0153] Protection may be sought for any feature disclosed in any one or more published documents referenced herein in combination with this disclosure.

[0154] Although specific embodiments of the present invention have been described, the scope of the appended claims is not intended to be limited to these embodiments only. The claims should be interpreted literally, in line with the purpose, and / or to encompass equivalents.

[0155] Throughout this specification, any reference to “one embodiment” or “one embodiment” means that a particular feature, structure, or characteristic described in relation to an embodiment is included in at least one embodiment. Therefore, occurrences of the phrase “in one embodiment” or “in one embodiment” in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, a particular feature, structure, or characteristic may be combined in any suitable manner in one or more embodiments.

[0156] The terms and expressions used herein are for illustrative purposes only and not for limitation, and in the use of such terms and expressions there is no intention to exclude equivalents of the illustrated and described features (or parts thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to encompass all such equivalents.

[0157] Embedding by reference Throughout this disclosure, references and citations are made to other documents, including patents, patent applications, patent publications, journals, books, articles, and web content. All such documents are incorporated herein by reference in their entirety for any purpose.

[0158] equivalent In addition to those shown and described herein, various modifications of the invention and many further embodiments thereof will be apparent to those skilled in the art from the entirety of this document, including references to the scientific and technical literature and patent documents cited herein. The subject matter of this specification includes important information, examples and guidance that can be adapted to the practice of the invention in its various embodiments and equivalents.

Claims

1. An intraurethral device, wherein the intraurethral device is A valve configured to be operated between an open configuration and a closed configuration by an external magnet, An intraurethral device comprising: a tube extending from the outlet port of the valve, wherein the tube defines a passage for fluid flow, and at least a portion of the passage is elliptical or amygdala-shaped.

2. An intraurethral device according to claim 1, further comprising a flange attached to the tube and configured to prevent movement of the device.

3. An intraurethral device according to claim 2, wherein the flange has a generally circular outer shape.

4. An intraurethral device according to claim 1, characterized in that the passage at its distal end is circular.

5. An intraurethral device according to claim 1, wherein the tube extends over at least a portion of the valve.

6. An intraurethral device according to claim 1, wherein the tube includes an outer shape that narrows between the valve and the distal end of the passage.

7. An intraurethral device according to claim 1, characterized in that the tube is flexible.

8. An intraurethral device, wherein the intraurethral device is A valve configured to be operated between an open configuration and a closed configuration by an external magnet, A catheter connected to the valve in fluid communication, wherein the operation of the valve controls the flow of fluid through the catheter, and the catheter and A retaining mechanism connected to the catheter, wherein the retaining mechanism is configured to deploy within the bladder, An intraurethral device comprising an end piece including a mounting element, the end piece being configured to be attached to a corresponding element of the other part of the device facing the retaining mechanism, the length of the device being defined between the retaining mechanism and the end piece, and the mounting element being configured to be detachably attached to the other part of the device.

9. An intraurethral device according to claim 8, characterized in that the mounting element and the corresponding element are correspondingly threaded elements configured to engage with each other.

10. An intraurethral device according to claim 8, wherein the mounting element and corresponding element form a twist-lock mounting configuration.

11. An intraurethral device according to claim 10, wherein the mounting element includes a head portion configured to pass through an opening defined by the corresponding element, and the head portion is configured to rotate to contact a contact portion of the corresponding element.

12. An intraurethral device according to claim 11, wherein the corresponding element includes a frame defining the opening.

13. An intraurethral device according to claim 12, wherein the frame defines a substantially semicircular opening or a substantially rectangular opening.

14. An intraurethral device according to claim 13, wherein the frame includes at least one string-shaped beam.

15. An intraurethral device according to claim 14, wherein the frame includes two string-shaped beams.

16. An intraurethral device according to claim 11, wherein the contact portion and the head portion include corresponding engagement structures, and the engagement structures are configured to prevent rotation of the contact portion and the head portion relative to each other when engaged with each other.

17. An intraurethral device according to claim 16, wherein the engagement structure includes at least one projection and a recess.

18. An intraurethral device according to claim 8, characterized in that the mounting element is configured to rotate about an axis with respect to the corresponding element.

19. An intraurethral device according to claim 8, wherein the mounting element and corresponding element include a passage through which a fluid flow from the valve through the end piece is permitted.

20. An intraurethral device, wherein the intraurethral device is A valve configured to be operated between an open configuration and a closed configuration by an external magnet, An intraurethral device comprising a corresponding element coupled to the valve, wherein the corresponding element is configured to be detachably attached to the other part or other element of the device in a twist-lock mounting arrangement by engagement of the corresponding element with a mounting element of the other part or other element of the device.

21. An intraurethral device according to claim 20, wherein the corresponding element defines an opening configured to receive the head portion of the mounting element, the head portion passes through the opening, and the corresponding element has a contact portion configured to contact the head portion following rotation of the head portion relative to the corresponding element.

22. An intraurethral device according to claim 20, wherein the corresponding element includes a frame defining an opening.

23. An intraurethral device according to claim 22, wherein the frame defines a substantially semicircular opening or a substantially rectangular opening.

24. An intraurethral device according to claim 23, wherein the frame includes at least one string-shaped beam.

25. An intraurethral device according to claim 24, wherein the frame comprises two string-shaped beams.

26. An intraurethral device according to claim 20, wherein the contact portion and the head portion include corresponding engagement structures, the engagement structures being configured to prevent rotation of the contact portion and the head portion relative to each other when engaged.

27. An intraurethral device according to claim 26, wherein the engagement structure includes at least one projection and a recess.

28. An intraurethral device according to claim 20, characterized in that the mounting element is configured to rotate about an axis with respect to the corresponding element.

29. An intraurethral device according to claim 20, wherein the mounting element and corresponding element include a passage through which a fluid flows from the valve through the end piece.

30. An insertion system for an intraurethral device, wherein the insertion system is An insertion tube configured to at least partially receive the intraurethral device, An intraurethral device comprising a plunger member configured to be at least partially received by the insertion tube, wherein the movement of the plunger member through the insertion tube pushes the intraurethral device out of the insertion tube.

31. An insertion system according to claim 30, further comprising the intraurethral device, wherein the intraurethral device includes a valve configured to be operated between an open configuration and a closed configuration by an external magnet, and a catheter coupled to the valve in fluid communication, wherein the operation of the valve controls the flow of fluid through the catheter.

32. A combination of an intraurethral device and an insertion system, The insertion system is, An insertion tube configured to receive the urethral device, at least in part, A plunger member configured to be at least partially received by the insertion tube, wherein the movement of the plunger member through the insertion tube is configured to push the urethral device out of the insertion tube, the plunger member comprises: The aforementioned intraurethral device is A valve configured to be operated between an open configuration and a closed configuration by an external magnet, A combination comprising: a corresponding element coupled to the valve, wherein the corresponding element is configured to be removably attached to the other part or other element of the device in a twist-lock mounting configuration by engagement of the corresponding element with a mounting element of the other part or other element, and the plunger member includes the mounting element, the corresponding element and the plunger member.

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