Intraurethral device

Abstract

An intraurethral device includes a valve configured to be actuated by an external magnet between an open configuration and a closed configuration; a conduit coupled in fluid communication with the valve such that actuation of the valve controls flow of fluid through the conduit; and a sealing member comprising at least one tubular collar and at least two circumferential annular annuluses extending from one or more of the at least one tubular collar, where a first of the circumferential annular annuluses has a first outer diameter or thickness, and a second of the circumferential annular annuluses has a second outer diameter or thickness. A first one of the circumferential annular rings has a first outer diameter or thickness, and a second one of the circumferential annular rings has a second outer diameter or thickness, the first outer diameter or thickness and the second outer diameter or thickness being different from each other.

Description

Cross-reference to related applications

[0001] This application claims priority and benefit to U.S. Provisional Application No. 63 / 452,356, filed March 15, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0002] The embodiments relate to urethral devices and insertion systems for placing urethral devices. Background Technology

[0003] Typically, it is desirable to provide an intraurethral device, such as a valve, that can selectively control the flow of fluid through it. For example, such a device may be needed for a patient with urinary retention defects.

[0004] An exemplary placement of this valve in a male patient can be seen in Figure 1, which is an excerpt from Figure 3 of US6066088. Reference numerals specifically referring to the prior art figures (Figures 1 and 2) will be presented in parentheses in this specification (reference numerals (without parentheses in this specification) will be used to refer to Figures 3 through 2). Figure 15 ).

[0005] As can be seen, Figure 1 shows a cross-section of the human male abdomen (30). The valve (1) may be located within the patient's bulbous urethra (26), generally at the bulge (17) and generally upstream of the pendulous urethra (27) (in relation to normal fluid flow through the urethra). The valve (1) is connected via a catheter (16) to a retention mechanism that defines a lumen (21) that serves as an outlet (25) at the valve (1) and an inlet defined by retention rings (28) of the retention mechanism. The retention mechanism is located in the bladder (29) and includes retention rings (28) that retain the retention mechanism in place relative to the bladder neck (22).

[0006] 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) and into the pendulous urethra 27.

[0007] Significant advancements in this area include the urethral magnetic valve of WO00 / 02499. For ease of reference, Figure 1 of that document is reproduced as Figure 2 of this application. The document teaches an urethral magnetic valve (1) for insertion into the human urethra of a person suffering from incontinence. The urethral magnetic valve (1) includes: a nonferromagnetic cylindrical housing (2); a valve seat assembly (36) attached to one end of the housing; a spherical magnetic valve element (14) configured for general movement within the housing; and an annulus (10) for retaining the valve element, the annulus being attached to the other end of the housing. The valve seat assembly (36) has a nonferromagnetic valve seat (4) and a ferromagnetic annulus (5). By attraction of the ferromagnetic annulus (5), the valve element (14) is held against the valve seat (4) in a closed check position, thereby restricting the flow of fluid through the valve (1). An external magnet is used to apply magnetic torque and attractive force to the valve element (14), thereby displacing it from the valve seat (4) and opening the valve to allow fluid flow. After the external magnet is removed, the valve element (14) returns to its closed check position on the valve seat (4).

[0008] The document also teaches a second embodiment in which the intraurethral magnetic valve (1) includes a mechanism with a spring for releasing excessive fluid pressure, wherein the valve seat assembly (36) is not attached to the housing but slides axially within the housing (2) against the force of the spring in the presence of excessive hydrostatic pressure to allow fluid to be released through a passage around the valve seat assembly (36).

[0009] This advanced intraurethral magnetic valve seeks to allow selective release of fluid from the bladder by using an external magnet; in other words, it allows a magnet outside the patient's body to be brought close to the internally located intraurethral magnetic valve to actuate it from a closed configuration to an open configuration.

[0010] However, even these intraurethral magnetic valves have their problems. For example, the valve may exhibit a poor seal around the catheter, between the outer portion of the catheter and the urethral wall. If a poor seal exists in this area, the valve may function correctly to prevent fluid flow through it unless it is actuated to the open configuration, but fluid may leak around the catheter, especially when the fluid pressure is relatively high.

[0011] The environment in which valves and catheters and their retention mechanisms are located can lead to crusting, such as mineralized biofilms of Proteus mirabilis or other microbial material. This can cause valve blockage or may affect the seal between the catheter and the wall of the urethra (which can cause leakage, as described above).

[0012] The placement of urethral valves is also a subject of development. Specifically, systems for placing urethral valves need to allow the valve, catheter, and associated retention mechanism to be pushed through the urethra into place. However, during this placement, it is not uncommon for the valve, catheter, and their retention mechanism to be pulled and twisted for accurate placement and navigation through the urethra. Typically, such placement systems require manipulation by a practitioner (e.g., a surgeon or other medically qualified person) and therefore do not enter the patient's urethra. All or part of this part of the placement system needs to be removable from the valve, catheter, and their retention mechanism after placement. Therefore, placement systems for urethral valve devices need to be able to navigate the valve, catheter, and their retention mechanism through the urethra into place and need to be at least partially removable after such placement.

[0013] One such example is WO2008 / 067557, which teaches a system for implanting a catheter in the urethra. The system includes a catheter having a magnetic internal urethral valve disposed at one end portion of the catheter. The system also includes a tool having an end member extending into an opening at the first end portion of the catheter to engage the tool with the catheter. The system also includes an element extending from the tool. The catheter has an internal path providing conduit for the element to extend through the valve to engage a second end portion of the catheter. The tool is adapted to use the element to apply stress to the catheter and stiffen the catheter along its length. Stiffening the catheter facilitates implantation into the urethra by achieving tensile, thrust, and torque forces.

[0014] Advances in the field of urethral valve placement can also be found in WO2011032150. This document teaches an insertion facilitator for facilitating the insertion of a tubular structure into a channel within a mammalian body. The device comprises: (a) an elongated reinforcement including a proximal portion and a distal portion, the reinforcement being adapted to: extend from its distal portion to its proximal portion within the lumen of the tubular structure, wherein the distal portion of the reinforcement is at least partially within the distal portion of the tubular structure and the proximal portion of the reinforcement is at least partially within the proximal portion of the tubular structure; provide stiffness to the tubular structure (stiffness with the reinforcement being greater than stiffness without the reinforcement); and axially displace relative to the tubular structure within the tubular structure; and (b) a coupling device, the coupling... The device is adapted to: releasably engage the reinforcement and the tubular structure in its engaged state, wherein the reinforcement extends within the lumen of the tubular structure such that either or both of the axial and radial displacement of the reinforcement relative to the tubular structure are substantially eliminated during insertion of the tubular structure into a body passage; and release the engagement between the reinforcement and the tubular structure in its disengaged state such that the reinforcement can be axially displaced at least within the lumen of the tubular structure and can be withdrawn at least from the tubular structure such that the proximal portion of the reinforcement is in or near the distal portion of the tubular structure.

[0015] As can be seen from the above documents, these systems for placing urethral valves are relatively complex, and there is an overall desire to simplify these systems.

[0016] As will be understood, positioning a valve device in a patient's urethra (male or female) can be uncomfortable. The valve device is pressed against the urethral wall for the purpose of forming a seal, see, for example, Figure 1. Furthermore, external forces can increase discomfort. For example, additional and / or different forces may act on the valve, catheter, and / or retention mechanism when the patient sits, walks, runs, or climbs stairs. These changes in force can alter the pressure on the urethral wall and surrounding tissues through the valve, catheter, and / or retention mechanism. This can increase the discomfort felt by the patient (in fact, the patient may only feel discomfort when performing certain activities, especially sitting). Therefore, there is a need to improve the overall comfort of using such valve devices. These and other issues were considered in the significant advances of WO2020089623. However, despite these advances, further progress and improved solutions continue to be needed for these and other issues related to intraurethral devices such as valve devices. Summary of the Invention

[0017] One aspect of the present invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet between an open configuration and a closed configuration; a conduit fluidly connected to the valve such that actuation of the valve controls the flow of fluid through the conduit; and a sealing member comprising at least one tubular collar and at least two circumferential annular rings extending from one or more of the tubular collars, wherein a first circumferential annular ring has a first outer diameter or thickness, and a second circumferential annular ring has a second outer diameter or thickness, the first outer diameter or thickness and the second outer diameter or thickness being different from each other.

[0018] At least two circumferential annular rings may include a third circumferential annular ring, wherein the first circumferential annular ring may be positioned away from the valve relative to the second circumferential annular ring, and the third circumferential annular ring may be positioned toward the valve relative to the second circumferential annular ring, such that the second circumferential annular ring may be positioned between the first circumferential annular ring and the third circumferential annular ring, and wherein the third circumferential annular ring may have a third outer diameter or thickness, which may be different from the second outer diameter or thickness.

[0019] The third outer diameter or thickness can be the same as the first outer diameter or thickness.

[0020] The third outer diameter or thickness can be the third outer diameter, the first outer diameter or thickness can be the first outer diameter, and the second outer diameter or thickness can be the second outer diameter.

[0021] The first outer diameter or thickness can be the first outer diameter, and the second outer diameter or thickness can be the second outer diameter.

[0022] The third outer diameter or thickness can be the third outer thickness, the first outer diameter or thickness can be the first outer thickness, and the second outer diameter or thickness can be the second outer thickness.

[0023] The first outer diameter or thickness can be the first outer thickness, and the second outer diameter or thickness can be the second outer thickness.

[0024] The sealing member may include one or more additional circumferential annular rings.

[0025] Each circumferential annular ring can be set on the same tubular collar.

[0026] One or more of the circumferential annular rings may be disposed on a tubular collar that is different from one or more other circumferential annular rings.

[0027] Each circumferential annular ring may include an annular groove, such that each circumferential annular ring has two circumferential portions.

[0028] Another aspect of the present invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet between an open configuration and a closed configuration; a conduit fluidly connected to the valve such that actuation of the valve controls the flow of fluid through the conduit; and a sealing member comprising a tubular collar and a first circumferential annular ring extending from the tubular collar, wherein the first circumferential annular ring includes a plurality of teeth.

[0029] The teeth may extend radially and be angled relative to the longitudinal axis of the tubular collar and / or conduit.

[0030] Each tooth may include a conical or truncated conical portion away from the tubular collar and / or conduit.

[0031] The device may further include a second circumferential annular ring extending from the tubular collar, wherein the second circumferential annular ring includes a plurality of teeth.

[0032] The device may further include an additional tubular collar and a second circumferential annular ring extending from the additional tubular collar, wherein the second circumferential annular ring includes a plurality of teeth.

[0033] Another aspect of the present invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet between an open configuration and a closed configuration; a conduit fluidly connected to the valve such that actuation of the valve controls the flow of fluid through the conduit; and a sealing member formed at least partially of a thermoplastic elastomer.

[0034] Thermoplastic elastomers can be styrene-ethylene-butene-styrene.

[0035] Another aspect of the present invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet between an open configuration and a closed configuration; a conduit fluidly connected to the valve such that actuation of the valve controls the flow of fluid through the conduit; and a sealing member having an outer wall at least partially defining a chamber configured to be at least partially inflated, wherein the chamber is at least partially filled with a foam material.

[0036] Another aspect of the present invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet between an open configuration and a closed configuration; a conduit fluidly connected to the valve such that actuation of the valve controls the flow of fluid through the conduit; and an extendable portion formed in the wall of the conduit by a plurality of annular corrugations such that the extendable portion can be compressed and extended by flexing the wall of the conduit around the annular corrugations.

[0037] Annular corrugations can form a series of annular regions with increasing outer diameters, interspersed with annular regions with decreasing outer diameters.

[0038] The extendable portion can be configured to expand radially under the force of fluid pressure within the catheter to help seal the catheter against the urethral wall during use.

[0039] Another aspect of the invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet between an open configuration and a closed configuration; a catheter fluidly connected to the valve such that actuation of the valve controls the flow of fluid through the catheter; a retention mechanism coupled to the catheter, wherein the retention mechanism is configured to unfold in the bladder; and a bladder seal or funnel coupled to the retention mechanism and configured to guide fluid from the bladder into the catheter and / or inhibit the movement of fluid from the bladder through the urethra surrounding the catheter.

[0040] The bladder seal or funnel may include an annular wall that extends outward from the catheter and is coupled to one or more arms or rings of the retention mechanism.

[0041] A ring-shaped wall can form a disk.

[0042] The disk can be connected to one or more rings or arms via one or more posts.

[0043] The annular wall can form a funnel.

[0044] Another aspect of the invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet between an open configuration and a closed configuration; a conduit fluidly connected to the valve such that actuation of the valve controls the flow of fluid through the conduit; and one or more of the following: a helical protrusion extending along a length of the conduit to provide a tortuous path for fluid flowing around the conduit; a mesh protrusion extending along a length of the conduit to provide a tortuous path for fluid flowing around the conduit; and a plurality of point protrusions extending radially and disposed along a length of the conduit to provide a tortuous path for fluid flowing around the conduit, wherein the point protrusions have a diameter and the spacing between adjacent point protrusions is less than the diameter.

[0045] Another aspect of the invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet between an open configuration and a closed configuration; a catheter fluidly connected to the valve such that actuation of the valve controls the flow of fluid through the catheter; a retention mechanism coupled to the catheter, wherein the retention mechanism is configured to unfold in the bladder; and a sheath configured to cover at least a portion of the retention mechanism during insertion of the device into the urethra.

[0046] After the device is assembled, the sheath in the urethra and / or bladder may be soluble or absorbable. Attached Figure Description

[0047] The features and advantages of the claimed subject matter will become clear from the following detailed description of the embodiments, consistent with the accompanying drawings, which should be considered in conjunction with the drawings.

[0048] Figure 1 shows the graph extracted from WO00 / 02499.

[0049] Figure 2 shows a graph extracted from US6066088.

[0050] Figure 3 illustrates a prior art intraurethral device.

[0051] Figures 4 and 5 show valves of the prior art.

[0052] Figure 6a and Figure 6b Views of some versions of the sealing component are shown.

[0053] Figure 7a and Figure 7b Views of some versions of the sealing component are shown.

[0054] Figure 8a and Figure 8b Views of some versions of the sealing component are shown.

[0055] Figure 9 Views of some versions of the sealing component are shown.

[0056] Figure 10 Views of some versions of the sealing component are shown.

[0057] Figure 11 Three versions of the device with extendable portions and / or sealing components are shown.

[0058] Figure 12a , Figure 12b and Figure 12c Three versions of the extendable portion and / or sealing component are shown.

[0059] Figure 13and Figure 14 A version with a bladder seal or funnel is depicted.

[0060] Figure 15 and Figure 16 Another version is depicted, featuring a bladder seal or funnel.

[0061] Figure 17 and Figure 18 A version depicting a tortuous flow path with spiral protrusions is described.

[0062] Figure 19 and Figure 20 Another version describes a tortuous flow path with features in the form of a network of protrusions.

[0063] Figure 21 and Figure 22 Another version describes the tortuous flow path with features in the form of point protrusions.

[0064] Figure 23 The device with a sheath is shown according to some versions, and Figure 24 The end of the valve is shown according to some versions.

[0065] To fully understand this disclosure, reference should be made to the following detailed description, including the appended claims, in conjunction with the foregoing drawings. Although this disclosure has been described in conjunction with exemplary embodiments, it is not intended to be limited to the specific forms listed herein. It should be understood that various omissions and equivalent substitutions are contemplated, as these may indicate or demonstrate advantages. Detailed Implementation

[0066] By way of summary, the present invention generally relates to an intraurethral device including a unique valve. Figures 3 to 4 of this application illustrate this. Figure 24 Various versions of intraurethral devices (specifically, device 1 including valve 11) are shown and mentioned. Valve 11 may be a magnetically actuated valve 11 for intraurethral placement. Thus, valve 11 may be an intraurethral magnetic valve 11.

[0067] Referring to Figures 4 and 5 (which are depictions of a prior art valve from WO2020 / 89623, the contents of which are incorporated herein by reference), valve 11 may, for example, include a valve body 111 defining an internal valve volume in which a spherical magnetic valve element 112 (hereinafter referred to as "valve element 112") is positioned. The internal valve volume has a length along a longitudinal axis of the valve body 111. The longitudinal axis of the valve body 111 extends from an inlet port 113 of the valve 11 to an 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.

[0068] Both inlet port 113 and outlet port 114 may have a width (e.g., diameter) smaller than the width of the internal valve volume.

[0069] The size of the internal valve volume is determined to receive valve element 112, for example, as depicted in Figures 3 and 4. The size of the internal valve volume can be determined to allow valve element 112 to move between a closed configuration and an open configuration, as described herein.

[0070] Facing the outlet port 114, there is a ferromagnetic member 115, which may be annular. The ferromagnetic member 115 defines a channel through which fluid can pass. The ferromagnetic member 115 is depicted in valve 11 in Figure 3.

[0071] The ferromagnetic component 115 can be a continuous ring of ferromagnetic material. Accordingly, the ferromagnetic component 115 can be generally tubular. In some versions, the ferromagnetic component 115 can be ring-shaped, because it can be formed not as a complete ring of ferromagnetic material, but as a ring structure formed by multiple segments of ferromagnetic material.

[0072] The ferromagnetic member 115 may have a first end facing the inner volume when it is in the valve 11 and a second end facing away from the inner volume (relative to the first end) when it is in the valve 11. The first end and the second end of the ferromagnetic member 115 may be opposite to each other across the length of the ferromagnetic member 115 (which may be parallel to the longitudinal axis of the valve 11 when the ferromagnetic member 115 is in the valve 11).

[0073] The ferromagnetic component 115 can be connected to the valve body 111, and this can be achieved in several different ways.

[0074] In some versions, the valve body 111 is formed of an elastomeric material, and may be formed solely of an elastomeric material. This elastomeric material can be selected for its biocompatibility and / or its ability to be impregnated with antimicrobial and / or antifungal agents. The ferromagnetic member 115 may be formed of a ferrous metal or a ferrous metal alloy. Therefore, compared to the ferromagnetic member 115, the valve body 111 can be formed of a relatively flexible material. In some versions, applying force to the valve body 111 can cause the valve body 111 to elastically deform and reduce the width of the internal valve volume (in the direction of the force). In other words, the body 111 can be resilient to the compressive forces it may be exposed to.

[0075] In some versions, the ferromagnetic member 115 may be embedded in at least a portion of the valve body 111, wherein the valve body 111 is 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, thus the ferromagnetic member may be placed inside the mold before the elastomeric material for the valve body 111 (or a portion thereof) is delivered to the mold (e.g., injected into a mold).

[0076] In some versions, the ferromagnetic member 115 can be secured within the valve body 111 by an interference fit. In such versions, the valve body 111 can be formed separately from the ferromagnetic member 115, wherein a recess defined by the valve body 111 is used to receive the ferromagnetic member 115. The ferromagnetic member 115 can then be inserted into the recess and held in place by, for example, an interference fit between one or more surfaces of the valve body 111 and the ferromagnetic member 115. In some versions, a plug of material (which may be an elastomeric material, such as the elastomeric material that can be used for the valve body 111) can be used to secure or assist in securing the ferromagnetic member 115 in place. This plug can be positioned toward the outlet port 114 of the valve 11 and can actually define the outlet port 114 (e.g., the plug may be annular in form), wherein the outlet port 114 is defined by the plug.

[0077] In some versions, the ferromagnetic member 115 can be fitted to the socket member of the valve body 111. The socket member can define a passage therethrough, and the ferromagnetic member 115 can slide into place on the socket member. A material plug can then be fitted onto the ferromagnetic member 115. The material plug can be generally annular in shape.

[0078] In some versions, adhesives may be used to secure or help secure the ferromagnetic component 115 to the valve body 111. In some versions, it will be understood that the socket component may be part of the valve body 111, and similarly, a material plug may form part of the valve body 111.

[0079] In some versions, the valve body 111 may be a tubular form with an open end, wherein a ferromagnetic member 115 is located at the opposite end (which forms an outlet, the width of which may be substantially smaller than the width of the open end). The open end may be configured to fit into another portion of the valve body 111 and / or the end of the conduit 12, which defines an inlet port 113 or an outlet of the conduit 12 forming the inlet port 113 of the valve 11. Thus, the valve element 112 can be positioned within the valve body via the open end of the valve body 111, after which the open end of the valve body is coupled to another portion of the body 111 and / or the end of the conduit 12 (the other portion of the body 111 may be coupled to the conduit 12). The conduit 12 may be integrally formed with at least a portion of the valve 11 (e.g., the body 111), or may be adhered to thereto, or may be joined using a cohesive process (e.g., insert molding).

[0080] In some versions where the valve body 111 is not molded around the ferromagnetic member 115 during manufacturing, the valve element 112 can be inserted through the outlet port 114 (or the end where the outlet port 114 of the valve body 111 will be located) before the ferromagnetic member 115 (and, for example, a plug) is inserted. For example, the elastomeric material of the valve body 111 can be configured to elastically deform to allow the valve element 112 to be inserted in this manner.

[0081] 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 a variety of different ways depending on the version. For example, in some versions, the valve seat 116 may be formed from the material that forms the valve body 111 where the ferromagnetic member 115 is located.

[0082] The portion of valve seat 116 configured to abut valve element 112 may have a radius that matches or substantially matches the outer radius of valve element 112. In some versions, the portion of valve seat 116 configured to abut valve element 112 may be configured to elastically deform upon contact with valve element 112. Such an arrangement may be configured to improve the seal between valve seat 116 and valve element 112.

[0083] In some versions, the separate ferromagnetic component 115 may not be used. For example, the valve seat 116 may be formed of an elastomer (e.g., silicone) that includes a filler material such as microsteel or iron balls or powder. In some versions, the ferromagnetic component 115 is provided as a separate piece relative to the valve seat 116, but is itself formed of an elastomer (e.g., silicone) that includes a filler material such as microsteel or iron balls or powder.

[0084] Therefore, in some versions, the end surface at the first end of the ferromagnetic member 115 can be covered by the material forming the valve body 111.

[0085] In some versions, the material of the valve body 11 covers the end surface of the first end of the ferromagnetic ring 5; however, in this version and some other versions, at least a portion of the passage through the valve 1 may be defined by the ferromagnetic ring 5, such that fluid passing through it may, for example, contact the ferromagnetic ring 5 (or at least a portion thereof). In these versions, the valve seat 4 may be formed of the material covering the end surface of the first end of the ferromagnetic ring 5.

[0086] In some versions, such as referring to Figure 5, the material of the valve body 111 covers the end surface of the ferromagnetic member 115 at its first end, but the remainder of the ferromagnetic member 115 is also substantially covered by the material of the valve body 111, such that fluid passing through it does not contact the ferromagnetic member 115 (or at least not most of it). In these versions, the valve seat 116 may be formed of the material covering the end surface of the ferromagnetic member 115 at its first end.

[0087] In some versions, a separate seat member is provided to form the seat 116. This separate seat member may be positioned adjacent to an end surface at a first end of the ferromagnetic member 115 and may be secured to the ferromagnetic member 115 and / or at least partially embedded in the material of the valve body 111. The seat member may be formed of, for example, an elastomeric material harder than the valve body 111, or may otherwise have one or more properties that enhance the seal between the valve element 112 and the seat 116 (compared to using the material of the valve body 111 for the seat 112). In some versions, the seat member may improve the consistency of the formation of the seat 116 (again, compared to using the material of the valve body 111 for the seat 112). The seat member may be formed of silicone with a different hardness than the valve body 111 (which may also be formed of silicone).

[0088] Device 1 (e.g., using valve 11) can be actuated between an open configuration and a closed configuration (e.g., by using an external magnet, which is outside device 1 and, when assembled, outside the body of the person to whom device 1 is assembled). In the open configuration, valve element 112 is spaced apart from valve seat 116 such that fluid can flow around valve element 112 and through outlet port 114. In the closed configuration, valve element 112 is seated against valve seat 116 such that outlet port 114 is substantially sealed and not in fluid communication with inlet port 113.

[0089] As will be understood, valve element 112 can be biased toward a closed configuration by magnetic attraction to ferromagnetic member 115. Additionally, when device 1 (e.g., valve 11) is positioned in the urethra as an intraurethral device (e.g., a valve) and oriented relative to the normal flow of fluid through it, in terms of fluid, inlet port 113 can be upstream of outlet port 114, such that fluid flow through valve 11 can also help bias valve element 112 toward a closed configuration.

[0090] Actuation of valve 11 to the open configuration can be achieved by using a magnetic component. The magnetic component can be positioned outside the patient to which valve 11 is fitted and moved to a relatively close proximity to valve 11 to achieve actuation from the closed configuration to the open configuration (by exposing valve 11 to the magnetic field of the magnetic component).

[0091] Actuation of the closed configuration can be achieved by the magnetic attraction between the valve element 112 and the ferromagnetic ring 115, and can be assisted by, for example, gravity and fluid flow through the valve 11, or both.

[0092] The valve 11 described herein can be fitted as an intraurethral magnetic valve 11 to a male or female patient. Referring to Figure 1, the valve 11 described herein can replace the valve (1) shown in Figure 1 and described in the document from which the figure is obtained, for details of the document, see above.

[0093] As described above, valve 11 can be coupled to catheter 12. Catheter 12 provides and defines a fluid flow path to valve 11, and particularly to the inlet port 113 of valve 11. Valve 11 may be an intraurethral valve, and catheter 12 may be correspondingly coupled to retention mechanism 14, which is configured to secure valve 11 and catheter 12 in a desired position. Some versions may omit retention mechanism 14 and may be held in place by the action of catheter 12 and / or valve 11 against the urethra.

[0094] The retention mechanism 14 can take many different forms and is configured to pass through the urethra to the desired location before being deployed. Upon deployment, the retention mechanism 14 helps to hold the catheter 12 and / or valve 11 in place. In some cases, deployment typically means the expansion or extension of at least a portion of the retention mechanism 14.

[0095] In some versions, the retention mechanism 14 may include a malecot, such as in Figure 3. Figure 6a , Figure 6b , Figure 7a , Figure 7b , Figure 8a , Figure 8b , Figure 9 , Figure 10 , Figure 11 and Figure 15 As shown. The retention mechanism 14 may include a plurality of arms, rings, or annexes that function when deployed to restrict movement of the conduit 12 and / or valve 11 coupled to the retention mechanism 14. Thus, the arms, rings, or annexes can move from a non-deployed or retracted configuration to a deployed or extended configuration. In this document, the arms, rings, or annexes are examples of deployable components of the retention mechanism 14, and this term will be used hereinafter.

[0096] Therefore, in some versions, device 1 is provided, which includes: valve 11, conduit 12 and retaining mechanism 14.

[0097] The length of the conduit 12 from the valve 11 to the retention mechanism 14 can be selected based on the desired placement of the valve 11, for example, as described herein.

[0098] As described above, the retention mechanism 14 may include a plurality of deployable members. These deployable members may extend radially outward relative to the catheter 12 such that they define a portion of the device 1 that is wider than the catheter 12 when deployed (but can retract to a width substantially the same as the catheter 12 when in an undeployed configuration). The deployable members may define spaces therebetween. These spaces may provide fluid communication between the volume surrounding the retention mechanism and the lumen defined by the catheter 12. In the case of an intraurethral system, this volume may be a bladder.

[0099] Accordingly, almost identical to that in Figure 1, the retention mechanism 14 can be positioned in the bladder neck, wherein the catheter 12 extends downward along the urethra (in the direction of normal fluid flow).

[0100] Some versions of valve 11 may be inserted or otherwise implanted using systems disclosed, for example, in WO00 / 02499 and / or WO2011 / 032150 and / or WO2020 / 089623, the details of which are incorporated herein by reference in their entirety.

[0101] Valve 11 may be, for example, the valve described in WO00 / 02499 and / or WO2011 / 032150 and / or WO2020 / 089623, the details of which are incorporated herein by reference in their entirety.

[0102] Magnetic components may be as described, for example, in WO00 / 02499 and / or WO2011 / 032150 and / or WO2020 / 089623, the details of which are incorporated herein by reference in their entirety.

[0103] Therefore, in use, device 1 can be located in the patient's bladder and urethra. In particular, retention mechanism 14 can be located in the bladder, wherein catheter 12 extends downward along the urethra, and valve 11 is positioned along the length of catheter 12 or at / towards the end of catheter 12 away from retention mechanism 14 (in some versions, the length of catheter 14 also extends from outlet port 113 of valve 11, such that valve 11 is located between two opposite ends of catheter 12).

[0104] seal In order for valve 11 to effectively control the flow of fluid (e.g., urine) through the urethra, the flow path of the fluid (or substantially all of the fluid) should be via catheter 12 and valve 11. Accordingly, a good seal is required between catheter 12 and the urethra.

[0105] Accordingly, in some versions (refer to Figures 6 to 12), at least one sealing member 15 is provided as part of the device 1. In some versions, there are multiple sealing members 15 that can be positioned along the length of the conduit 12 (between the valve 11 and the retention mechanism 14, i.e., upstream of the valve 11 in terms of the intended flow direction of urine). If multiple sealing members 15 are provided, more than one type of sealing member 15 can be provided, as described herein. At least one sealing member 15 can be positioned adjacent to the retention mechanism 14.

[0106] In some versions, the sealing member 15 is a tubular collar 151 assembled around the length of the conduit 12. The tubular collar 151 can slide onto the conduit 12 and be secured in place, for example, by any suitable arrangement (such as welding or adhesive).

[0107] In some versions, the tubular collar 151 includes a plurality of circumferential annular rings 152. These circumferential annular rings 152 may be spaced apart along the length of the tubular collar 151 and each may extend around the circumference of the conduit 12. In some versions, the outer diameter of each of the plurality of circumferential annular rings 152 may be substantially the same as each of the other circumferential annular rings 152 of the same tubular collar 151 or at least one other circumferential annular ring 152 of the tubular collar 151. Each circumferential annular ring 152 may have a rectangular or curved cross-sectional profile (e.g., cut through the diameter of the circumferential annular ring 152 and considering one 'end' of such a cross-section), see, for example, [link to relevant documentation]. Figure 6a and Figure 6b Therefore, each circumferential annular ring 152 can form a rib.

[0108] In some versions (see) Figure 7a and Figure 7bThe (radial) extension distance (e.g., height) of the circumferential annular ring 152 varies along the length of the tubular collar 151, such that the circumferential annular ring 152 has a greater extension height compared to another circumferential annular ring in the circumferential annular ring 152. In other words, the outer diameter of the circumferential annular ring 152 can differ between the circumferential annular rings 152 of the tubular collar 151 (the relative diameter of the circumferential annular ring 152 mentioned herein should be considered equivalent to the radial extension height of the circumferential annular ring 152). This extension distance can be measured relative to the tubular collar 151 (or the collars 151), but can be the extension distance from the central axis of the conduit 12. In some versions, the outer diameter of the first circumferential annular ring 152 facing the retention mechanism 14 is smaller (relative to the first circumferential annular ring 152) than the outer diameter of the second circumferential annular ring 152 positioned away from the retention mechanism 14. In practice, in some versions, the diameter of the circumferential annular ring 152 can increase with distance from the retaining mechanism 14. In some versions, the outer diameter of the circumferential annular ring 152 can reach a maximum value at a first distance from the retaining mechanism 14, and then decrease for circumferential annular rings 152 further away from the retaining mechanism 14 than the first distance. In some versions, there are an equal number of circumferential annular rings 152 on either side of the circumferential annular ring 152 with the largest diameter. In some versions, on either side of the circumferential annular ring 152 with the largest outer diameter, the outer diameter of the circumferential annular ring 152 gradually decreases uniformly relative to each other. In some versions, the circumferential annular ring 152 with the largest diameter is generally located in the middle of the tubular collar 151.

[0109] In some versions, the extension length of one circumferential annular ring 152 along the length of the tubular collar 151 and / or conduit 12 differs from that of another circumferential annular ring 152. In other words, the thickness (along the length of the tubular collar 151 or conduit 12) can vary from one circumferential annular ring 152 to another (of the same device 1). Therefore, this can affect the degree of flexibility of the circumferential annular ring 152, and this flexibility can vary along the length of the tubular collar 151 and / or conduit 12 (by changing the thickness or otherwise (e.g., by using different materials)), with one circumferential annular ring 152 having a different flexibility than the other or each of the other circumferential annular rings 152. In some versions, the flexibility decreases toward the retaining mechanism 14 or toward the valve 11. In some versions, the flexibility decreases toward the central circumferential annular ring 152 and then increases again (making the flexibility minimum at the central circumferential annular ring 152). In some versions, the flexibility increases toward the central circumferential annular ring 152, and then increases again (so that the flexibility is maximum at the central circumferential annular ring 152).

[0110] As will be understood, in some versions, one or more circumferential annular rings 152 may each be described as fins.

[0111] In some versions, each circumferential annular ring 152 includes a groove (see...) Figure 7a and Figure 7b The groove can be a circumferential groove. In some versions, the groove can be positioned around the midline of each circumferential annular ring 152. In this way, the groove can define two circumferential portions of each circumferential annular ring 152. Each of these two portions can be generally annular. This arrangement allows the two portions to move relative to each other during insertion and removal of the catheter 12 and can help retain the catheter 12 within the urethra. In some versions, there is more than one such groove, allowing more than two portions to be defined.

[0112] In some versions, the thickness of the circumferential annular ring 152, or each circumferential annular ring, is greatest near the tubular collar 151 and / or conduit 12, and decreases as the circumferential annular ring 152 extends away from the tubular collar 151 and / or conduit 12. In other words, each circumferential annular ring 152 may gradually taper (i.e. become thinner) as it extends away from the tubular collar 151 and / or conduit 12. As noted, the thickness of the circumferential annular ring 152 is the length of the circumferential annular ring 152 along the tubular collar 151 and / or conduit 12. This facilitates easy insertion of the device 1.

[0113] In some versions, each circumferential annular ring 152 has its own tubular collar 151, but the tubular collar 151 can be arranged to provide a corresponding arrangement of the circumferential annular rings 152, as described herein.

[0114] In some versions, each circumferential annular ring 152 is a generally uniform ring with a constant or substantially constant radius. However, in some versions (see...) Figure 8a and Figure 8bEach circumferential annular ring 152 may include one or more protrusions or teeth that project radially, such that the radius of the circumferential annular ring 152 varies around the circumference of the tubular collar 151. In some versions, each circumferential annular ring 152 is an annular ring with protrusions or teeth. Such protrusions may have rounded ends or pointed ends (such as forming teeth). In some versions, the protrusions or teeth may extend radially relative to the tubular collar 151 and / or the catheter 12. In some versions, the protrusions or teeth may be angled relative to the longitudinal axis of the tubular collar 151 or the catheter 12, such that they form barbs that impede movement of the tubular collar 151 and / or the catheter 12 in a direction away from the bladder. This can therefore help retain the catheter 12 in place. In some versions, circumferential annular rings 152 with protrusions or teeth alternate with one or more circumferential annular rings 152 having a constant or substantially constant radius to aid in sealing. In some versions, a circumferential annular ring 152, including teeth or protrusions, is disposed on its own tubular collar 151 as described above. The teeth may have a generally triangular shape with points designed to contact the urethra. In some versions, the teeth are generally cylindrical protrusions extending substantially radially from the tubular collar 151 and / or catheter 12. In some versions, the cylindrical protrusions taper gradually away from the ends of the tubular collar 151 and / or catheter 12. In some such versions, each tooth may include a conical or truncated conical portion away from the tubular collar 151 and / or catheter 12.

[0115] In some versions, there are two or more circumferential annular rings 152. In some versions, there are six or more circumferential annular rings 152. In some versions, there are ten or more circumferential annular rings 152. In some versions, there are fewer than twenty circumferential annular rings 152. In some versions, there are fewer than fifteen circumferential annular rings 152.

[0116] In some versions (see) Figure 9The sealing member 15 includes at least a portion formed of a thermoplastic elastomer (such as styrene-ethylene-butene-styrene), which may be mixed with additives (such as oils or fillers). The sealing member 15 formed of such a material may or may not include a circumferential annular ring 152. The sealing member 15 formed of such a material may be a tubular collar 151, or may include a tubular collar 151 as described herein. In some versions, the diameter of the sealing member 15 formed of such a material may increase as the sealing member 15 extends away from the retention mechanism 14, up to a maximum diameter. From the region of maximum diameter, the diameter of the sealing member 15 may decrease towards the valve 11. The sealing member 15 may be configured to conform to the urethra after insertion (and possibly during insertion) to provide a good seal between the urethra and the catheter 12.

[0117] In some versions (see) Figure 10 The sealing member 15 may be in the form of a tubular collar 151, which includes an outer wall 153 with a diameter larger than the outer diameter of the conduit 12. The outer wall 153 may include (e.g., by using adhesives or welding) an end connected to the conduit 12 and / or to the inner wall of the tubular collar 151, which is configured to surround the conduit 12 assembly (and may contact the conduit 12 along its length). Thus, this form of tubular collar 151 can define a chamber between the outer wall 153 and the inner wall or conduit 12. This chamber may be at least partially inflated and may be a sealed chamber. In some versions, the chamber may be fluidly connected to an inflation line via a chamber valve, which may be located within the chamber and may be a one-way valve (which allows fluid to enter the chamber but prevents or substantially prevents fluid from being released from the chamber via the inflation line). Accordingly, in some versions, after insertion with the chamber deflated, the chamber can be at least partially inflated, and this can be achieved by allowing air or another fluid through the inflation tube (or by pumping air or another fluid through the inflation tube). The inflation tube can be cut off after insertion and inflation so that it does not extend from the urethra.

[0118] In some versions, the chamber may be filled or partially filled with foam material. This can be open-cell foam material. The foam material can facilitate the inflation of the chamber. For example, the foam material can be compressed during insertion and can be allowed to expand during inflation.

[0119] In some of these versions, the inflation tube may be omitted.

[0120] In some versions, a portion of the catheter 12 (which may be a portion adjacent to the retention mechanism 14) may include an extendable portion 16 (see, for example, see...). Figure 11 and Figures 12a to 12cThe extendable portion 16 may be formed by the wall of the conduit 12 and may include a series of annular corrugations. The annular corrugations in the wall of the conduit 12 may define annular rings around which the wall of the conduit 12 may flex, allowing the extendable portion 16 to be compressed and extended (e.g., like a hexagonal accordion). In some versions, the annular rings may be formed at least partially by a conduit wall that is thinner than adjacent portions. Thus, the annular corrugations may form a series of annular regions with increasing outer diameters, interspersed with annular regions with decreasing outer diameters. In some versions, two or more such regions with increasing outer diameters may be present. In some versions, three or more such regions with increasing outer diameters may be present. In some versions, five or more such regions with increasing outer diameters may be present. The length of the corrugations along the conduit 12 and / or their diameter may be selected to achieve the desired degree of flexibility and extension.

[0121] The extendable portion 16 may allow for variations in the length of the catheter 12 and / or may help ensure that the device 1 remains in place (i.e., is secured). In some versions, the extendable portion 16 may also help provide a seal between the catheter 12 and the urethra. Therefore, in some versions, the extendable portion 16 may also be considered as the sealing member 15.

[0122] For example, the extendable portion 16 can be configured (e.g., by the thickness and / or flexibility of the material used for the portion 16, and / or by a design of annular corrugations) to expand radially under the influence of fluid pressure within the catheter 12. This can thus contribute to a seal between the catheter 12 and the urethra, particularly when the pressure of the fluid (e.g., urine) within the urethra is at its maximum.

[0123] When it comes to the removal of device 1, the extendable portion 16 can extend under a pulling force (e.g., a manual removal force) acting on device 1. This allows the extendable portion 16 to extend, which can have the effect of reducing its diameter, and thus this can facilitate the removal of device 1.

[0124] In some versions (see) Figures 13 to 16 Device 1 may include a bladder seal or funnel 141. The bladder seal or funnel 141 may be configured to be located within the bladder when assembled and may be used to inhibit or prevent the flow of fluid (e.g., urine) through the urethra surrounding the catheter 12 (instead of through the catheter 12) and / or to allow fluid (e.g., urine) through the funnel into the catheter 12.

[0125] The bladder seal or funnel 141 can be considered as part of the retention mechanism 14 (or as a feature coupled to the retention mechanism) and can be configured to be actuated together with the retention mechanism between a collapsing configuration and an extended configuration. Thus, the bladder seal or funnel 141 may include a wall, which may be an annular wall extending outward from the catheter 12. The wall can be connected to move together with portions of the retention mechanism 14 (such as rings or arms, which may be part of a Mahlecott fixation element) such that actuation of the retention mechanism 14 between a retracted and extended configuration also causes actuation of the bladder seal or funnel 141 between a collapsing and extended configurations. This can facilitate insertion of the device 1 and can be achieved by using a guidewire of the device 1 (which can be used in this and other versions to retract and extend the retention mechanism 14).

[0126] The bladder seal or funnel 141 may be in the form of a funnel (see, for example, see...). Figure 13 and Figure 14 The wall of the catheter 12 provides an annular surface that descends toward the catheter 12 in its normal assembly orientation to guide fluid (e.g., urine) toward the catheter 12.

[0127] The bladder seal or funnel 141 may be in the form of a disc (see, for example, see...). Figure 15 and Figure 16 The wall of the catheter 12 provides an annular surface that extends radially from the catheter 12 (i.e., generally perpendicular to the catheter extension). This version can provide a better seal near the bladder neck.

[0128] As can be seen, in some versions, the bladder seal or funnel 141 may be connected along the length of the arm or ring of the retention mechanism 14, or may be connected to it via a corresponding post. The use of the post 142 (which extends from the ring or arm to the wall of the bladder seal or funnel 141) allows the angle of the wall of the bladder seal or funnel 141 relative to the catheter 12 to be set by the length of the post 142.

[0129] This bladder seal or funnel 141 can be provided in combination with any other version of the technology described herein.

[0130] winding path In some versions (for example, see...) Figures 17 to 22 The tubular collar 151 can provide a tortuous path for fluid through the urethra surrounding the outer side of the catheter 12 (this tortuous path can be configured as a sealing member 15 or any other form of sealing member 15 besides that described herein). In some versions, the catheter 12 itself can be configured to provide such a tortuous path, and this tortuous path can provide another form of sealing member 15 besides that described herein.

[0131] The configuration of the tortuous path can be described with reference to the configuration provided by the conduit 12 itself, but the description will also apply to the same configuration that is set as part of the tubular collar 151, or in fact, to one of the tubular collars 151 that is set as part of the device 1.

[0132] In some versions, the meandering path can be represented by a spiral protrusion 121 (see, for example, see...). Figure 17 and Figure 18 The helical protrusion 121 extends around a portion of the length of the catheter 12. The helical protrusion 121 may be positioned adjacent to the retention mechanism 14 and / or adjacent to the valve 11. In some versions, the helical protrusion 121 is positioned along the entire length or substantially the entire length of the catheter 12, and in some versions, a sealing member 15 may be positioned on at least a portion of the helical protrusion 121. The helical protrusion 121 may provide a flow path for fluids (e.g., urine) from the bladder through the urethra, a path that is longer than would otherwise be (e.g., longer than a path directly downwards along the side of the catheter 12).

[0133] In some versions, the tortuous path can be provided by a mesh protrusion 122, which can provide diamond-shaped mesh protrusions extending from the conduit 12 (e.g., in...). Figure 19 and Figure 20 It is depicted as extending from the tubular collar 151 of the sealing member 15.

[0134] In some versions, the mesh protrusion 122 may be formed of an inflatable member, wherein the outer wall of the inflatable member provides the mesh protrusion, or the mesh protrusion 122 may be disposed on an inflatable tubular collar 151. The inflatable tubular collar 151 may be an inflatable sealing member 15 as described herein (i.e., see the version described as including an outer wall 153). In some versions, the mesh protrusion 122 may be provided as a compressible foam material or elastomer, such that the mesh protrusion 122 can deform upon contact with the urethra.

[0135] In some versions, the meandering path can be provided by multiple point protrusions 123 (see, for example, see...). Figure 21 and Figure 22 These point protrusions 123 may extend radially from the conduit 12 and / or the tubular collar 151. The point protrusions 123 may be closely spaced. For example, the spacing between adjacent point protrusions 123 may be less than the diameter of each point protrusion 123 (e.g., the point protrusions 123 may all have the same diameter).

[0136] The protrusion 123 may be positioned adjacent to the retaining mechanism 14 and / or the valve 11. In some versions, the protrusion 123 is positioned along the entire length or substantially the entire length of the catheter 12, and in some versions, the sealing member 15 may be positioned on at least some of the protrusions in the protrusion 123. The protrusion 123 may provide a flow path for fluids (e.g., urine) from the bladder through the urethra, a path that is longer than would otherwise be (e.g., longer than a path directly downward along the side of the catheter 12).

[0137] If the point protrusion 123 is a protrusion of the conduit 12, the point protrusion may be formed of the same material as the conduit 12, and if the point protrusion is a protrusion of the tubular collar 151, the point protrusion may be formed of the same material as the tubular collar 151.

[0138] In some versions, tortuous path features (e.g., point protrusions 123, spiral protrusions 121, and / or mesh protrusions 122, or any other suitable form of protrusion forming a tortuous path) may be formed during the molding process (e.g., when molding conduit 12). In some versions, tortuous path features may be provided by removing material from conduit 12 or from tubular collar 151 or both in the form of molding and cutting (e.g., cutting or grinding).

[0139] Insertion and Removal In some versions, see Figure 23 (For example, it is a schematic representation in cross-sectional form without depicting details of valve 11 or catheter 12), device 1 may be provided with a sheath 17. In some versions, sheath 17 may be provided as a component of device 1 within the urethra, but in other versions, sheath 17 may be considered to be provided separately from device 1, as explained herein.

[0140] In versions including sheath 17, sheath 17 can be provided to assist insertion. Thus, sheath 17 can be present during the insertion process and also shortly after insertion; however, sheath 17 may be absent for most of the lifespan of the device 1 when it is in use (i.e., the time during which the device 1 is fitted to the patient and in operation before final removal).

[0141] The sheath 17 may be configured to cover at least a portion of the retention mechanism 14 (which may be the retention mechanism 14 as described herein or some other retention mechanism not described herein). Thus, the retention mechanism 14 may include, for example, a bladder seal or a funnel 141.

[0142] The sheath 17 can be configured to help keep one or more portions of the retention mechanism 14 together with the retention mechanism 14 in an unextended or retracted configuration (e.g., before the retention mechanism 14 is changed to an extended or extended configuration).

[0143] The sheath 17 may be in the form of a tube, which in some versions is fitted around the entire circumference of the device 1 along at least a portion of its length. For example, the sheath 17 may be in the form of a tube having a closed end or an open end, as described herein. In the version with a closed end, the closed end may be positioned adjacent to the retention mechanism 14 (and the sealed end may be remote from the conduit 12 relative to the retention mechanism 14). The closed end may be a sealed or substantially sealed end.

[0144] The sheath 17 can be formed of a flexible material or a rigid material.

[0145] The sleeve 17 may extend around all or part of the retaining mechanism 14 and around all or part of the conduit 12. In some versions, the sleeve 17 may extend around all or part of the valve 11.

[0146] The sheath 17 may have an inner diameter smaller than the outer diameter of the retention mechanism 14 in its deployed configuration, so that the sheath 17 can help prevent the retention mechanism 14 from deploying. In some versions, the retention mechanism 14 is held in its undeployed configuration by a guide wire or the like. Therefore, in some versions, the sheath 17 may not be used to prevent the retention mechanism 14 from deploying, but rather to (e.g., through lubrication or by a lower coefficient of friction) facilitate the movement of the retention mechanism 14 through the urethra.

[0147] The sheath 17 may be coated with a lubricating material and / or an anti-corrosion material and / or an antibiotic material.

[0148] The sheath 17 can be formed of a soluble material. This material can be configured to dissolve within the patient's body (e.g., in the urethra and / or bladder). The sheath 17 can also be formed of an absorbable material. This material can be configured to be absorbed within the patient's body.

[0149] In some versions, the sheath 17 may be a woven structure formed of a soluble or absorbable material.

[0150] In some versions, the material used to form the sheath 17 can be the same as the material used for the dissolvable suture.

[0151] In some versions, the sheath 17 is formed from a polysaccharide polymer (such as pullulan), which can form a film (and is currently used in breath freshener tablets and drug delivery).

[0152] In some versions, exposure to urine after assembly (or during assembly) may help dissolve and / or absorb the sheath 17.

[0153] In some versions, the sheath 17 may be in the form of a tube with a closed end, which may include one or more portions made of a soluble or absorbable material, wherein the remainder of the sheath 17 is formed of a non-soluble or non-absorbable material, such that the one or more portions may weaken and break after insertion into the patient, allowing the sheath 17 to be retrieved using, for example, one or more tethers extending from it to the outside of the patient (where the device 1 is secured in the assembled configuration). Thus, these portions allow the closed end to open (or fully open to allow the device 1 to pass through).

[0154] In some versions, the sheath 17 can be configured to break or tear under the force that causes the retention mechanism 14 to change its deployed configuration. This may be the case in versions with or without the aforementioned soluble or absorbable material. The sheath 17 may have one or more weak lines, points, or areas to allow or facilitate breakage or tearing in this manner. The sheath 17 can be protected against premature breakage or tearing by, for example, guide wires or other elements that retain the retention mechanism in its undeployed configuration.

[0155] In some versions, the sleeve 17 can be fitted onto the device 1 (or a portion thereof) by inserting the device 1 (or a portion thereof) into the sleeve 17. In some versions, the sleeve 17 can be cast around the device 1 (in a mold).

[0156] Accordingly, the sheath 17 can be considered part of the device 1 when it is ready for insertion and possibly after insertion. However, the sheath 17 is intended to be removed for normal operation of the device 1. The sheath 17 can facilitate the insertion of the device 1 into and through the urethra.

[0157] In some versions, valve 11 may be the part of device 1 furthest from retention mechanism 14 (and therefore furthest from the bladder when assembled). Accordingly, to facilitate removal of device 1, some versions may include valve 11 with a tapered end surface. Consequently, as device 1 travels away from the urethra, the tapered end surface is less likely to cause discomfort or damage compared to the sharp edges between, for example, the outer circumferential surface of valve 11 (e.g., valve body 111) and the end surface of valve 11 (e.g., valve body 111). This is in Figure 24 The diagram is shown schematically (see also: for comparison). Figure 23 (The sharp edge on the end of valve 11).

[0158] When used in this specification and claims, the terms "comprising" and "including," and variations thereof, mean to include the specified features, steps, or integers. These terms should not be construed as excluding the presence of other features, steps, or components.

[0159] The invention may also broadly include any and all combinations of said parts, elements, steps, examples, and / or features that are individually or collectively mentioned or indicated in the specification as two or more 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 from any other embodiment described herein.

[0160] You may seek protection for any feature disclosed in any one or more public documents referenced in connection with this disclosure.

[0161] Although certain exemplary embodiments of the invention have been described, the scope of the appended claims is not intended to be limited to these embodiments. The claims should be interpreted literally and intentionally, and / or cover equivalents.

[0162] Throughout this specification, references to "an embodiment" or "an embodiment" mean that at least one embodiment includes a particular feature, structure, or characteristic described in connection with that embodiment. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, specific features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0163] The terms and expressions used herein are for descriptive purposes and not for limitation, and in using such terms and expressions, it is not intended to exclude any equivalents of the features (or portions thereof) described and illustrated, and it should be recognized that different modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

[0164] Incorporation Throughout this disclosure, other documents, such as patents, patent applications, patent publications, magazines, books, papers, and web content, have been referenced and cited. All of these documents are hereby incorporated in their entirety by reference for all purposes.

[0165] equivalent In addition to those shown and described herein, various modifications to the invention and many other embodiments thereof will become apparent to those skilled in the art from the entire contents of this document (including references to scientific and patent documents cited herein). The subject matter of this document contains important information, examples, and guidance applicable to the practice of the invention in its various embodiments and equivalents.

Claims

1. A urethral device, comprising: A valve configured to be actuated by an external magnet between an open configuration and a closed configuration; A conduit is connected in fluid communication with the valve, such that actuation of the valve controls the flow of fluid through the conduit; as well as A sealing member comprising at least one tubular collar and at least two circumferential annular rings extending from one or more of the at least one tubular collar, wherein a first circumferential annular ring has a first outer diameter or thickness, and a second circumferential annular ring has a second outer diameter or thickness, the first outer diameter or thickness and the second outer diameter or thickness being different from each other.

2. The urethral device as claimed in claim 1, wherein, The at least two circumferential annular rings include a third circumferential annular ring, wherein the first circumferential annular ring is positioned away from the valve relative to the second circumferential annular ring, and the third circumferential annular ring is positioned toward the valve relative to the second circumferential annular ring, such that the second circumferential annular ring is located between the first circumferential annular ring and the third circumferential annular ring, and wherein the third circumferential annular ring has a third outer diameter or thickness, the third outer diameter or thickness being different from the second outer diameter or thickness.

3. The urethral device as described in claim 2, wherein, The third outer diameter or thickness is the same as the first outer diameter or thickness.

4. The urethral device as claimed in claim 3, wherein, The third outer diameter or thickness is the third outer diameter, the first outer diameter or thickness is the first outer diameter, and the second outer diameter or thickness is the second outer diameter.

5. The urethral device as claimed in claim 3, wherein, The third outer diameter or thickness is the third outer thickness, the first outer diameter or thickness is the first outer thickness, and the second outer diameter or thickness is the second outer thickness.

6. The urethral device as claimed in claim 1, wherein, The first outer diameter or thickness is the first outer diameter, and the second outer diameter or thickness is the second outer diameter.

7. The urethral device as claimed in claim 1, wherein, The first outer diameter or thickness is the first outer thickness, and the second outer diameter or thickness is the second outer thickness.

8. The urethral device as claimed in claim 1, wherein, The sealing member includes one or more additional circumferential annular rings.

9. The urethral device as claimed in claim 1, wherein, Each circumferential annular ring is set on the same tubular collar.

10. The urethral device as claimed in claim 1, wherein, One or more of the circumferential annular rings are disposed on a tubular collar that is different from one or more other circumferential annular rings.

11. The urethral device as claimed in claim 1, wherein, Each circumferential annular ring includes an annular groove, such that each circumferential annular ring has two circumferential portions.

12. An intraurethral device, comprising: A valve configured to be actuated by an external magnet between an open configuration and a closed configuration; A conduit is connected in fluid communication with the valve, such that actuation of the valve controls the flow of fluid through the conduit; as well as A sealing member comprising a tubular collar and a first circumferential annular ring extending from the tubular collar, wherein the first circumferential annular ring comprises a plurality of teeth.

13. The urethral device as claimed in claim 12, wherein, The teeth extend radially and are angled relative to the longitudinal axis of the tubular collar and / or conduit.

14. The urethral device as claimed in claim 13, wherein, Each tooth includes a conical or truncated conical portion away from the tubular collar and / or the conduit.

15. The urethral device of claim 12, further comprising a second circumferential annular ring extending from the tubular collar, wherein, The second circumferential annular ring includes multiple teeth.

16. The urethral device of claim 12, further comprising an additional tubular collar and a second circumferential annular member extending from said additional tubular collar, wherein, The second circumferential annular ring includes multiple teeth.

17. An intraurethral device, comprising: A valve configured to be actuated by an external magnet between an open configuration and a closed configuration; A conduit is connected in fluid communication with the valve, such that actuation of the valve controls the flow of fluid through the conduit; as well as A sealing member, said sealing member being at least partially formed of a thermoplastic elastomer.

18. The urethral device as claimed in claim 17, wherein, The thermoplastic elastomer is styrene-ethylene-butene-styrene.

19. An intraurethral device, comprising: A valve configured to be actuated by an external magnet between an open configuration and a closed configuration; A conduit is connected in fluid communication with the valve, such that actuation of the valve controls the flow of fluid through the conduit; as well as A sealing member having an outer wall that at least partially defines a chamber configured to be at least partially inflated, wherein the chamber is at least partially filled with a foam material.

20. An intraurethral device, comprising: A valve configured to be actuated by an external magnet between an open configuration and a closed configuration; A conduit is connected in fluid communication with the valve, such that actuation of the valve controls the flow of fluid through the conduit; as well as An extendable portion is formed in the wall of the conduit by a plurality of annular corrugations, such that the extendable portion can be compressed and extended by flexing the wall of the conduit around the annular corrugations.

21. The urethral device as claimed in claim 20, wherein, The annular ripples form a series of annular regions with increasing outer diameters, interspersed with annular regions with decreasing outer diameters.

22. The urethral device as claimed in claim 17, wherein, The extendable portion is configured to expand radially under the force of fluid pressure within the catheter to facilitate sealing the catheter against the urethral wall during use.

23. An intraurethral device, comprising: A valve configured to be actuated by an external magnet between an open configuration and a closed configuration; A conduit is connected in fluid communication with the valve, such that actuation of the valve controls the flow of fluid through the conduit; A retention mechanism, connected to the catheter, wherein the retention mechanism is configured to deploy within the bladder; as well as A bladder seal or funnel, which is coupled to the retention mechanism and configured to guide fluid from the bladder into the catheter and / or inhibit the movement of fluid from the bladder through the urethra surrounding the catheter.

24. The urethral device as claimed in claim 23, wherein, The bladder seal or funnel includes an annular wall that extends outward from the catheter and is coupled to one or more arms or rings of the retention mechanism.

25. The urethral device as claimed in claim 24, wherein, The annular wall forms a disk.

26. The urethral device as claimed in claim 25, wherein, The disk is connected to the one or more rings or arms via one or more posts.

27. The urethral device as claimed in claim 24, wherein, The annular wall forms a funnel.

28. An intraurethral device, comprising: A valve configured to be actuated by an external magnet between an open configuration and a closed configuration; A conduit, which is fluidly connected to the valve such that actuation of the valve controls the flow of fluid through the conduit; and One or more of the following: A spiral protrusion extends along a section of the conduit to provide a tortuous path for fluid flowing around the conduit; A mesh protrusion extends along a section of the conduit to provide a tortuous path for fluid flowing around the conduit; as well as Multiple point protrusions, which extend radially and are disposed along a length of the conduit to provide a tortuous path for fluid flowing around the conduit, wherein the point protrusions have a diameter and the spacing between adjacent point protrusions is smaller than the diameter.

29. An intraurethral device, comprising: A valve configured to be actuated by an external magnet between an open configuration and a closed configuration; A conduit is connected in fluid communication with the valve, such that actuation of the valve controls the flow of fluid through the conduit; A retention mechanism, connected to the catheter, wherein the retention mechanism is configured to deploy within the bladder; as well as A sheath, configured to cover at least a portion of the retention mechanism during insertion of the device into the urethra.

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