Intraurethral devices

Abstract

The intraurethral device includes a valve configured to be actuated by an external magnet to switch between an open configuration and a closed configuration, a catheter coupled to the valve in fluid communication, wherein the actuation of the valve controls the flow of fluid through the catheter, and 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 the first of the circumferential annular rings has a first outer diameter or outer thickness, and the second of the circumferential annular rings has a second outer diameter or outer thickness, and the first and second outer diameters or outer thicknesses are different from each other.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 452,356, filed on Mar. 15, 2023, the content of which is hereby incorporated by reference in its entirety into this specification. Technical Field Embodiments relate to intraurethral devices, and insertion systems for placing intraurethral devices, among other things.

Background Art

[0002] Background Generally, there is a desire 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 obstruction disorders.

[0003] An exemplary placement of such a valve in a male patient can be seen 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 (FIG. 1 and FIG. 2) will be shown in parentheses (reference numerals will be used to refer to FIGS. 3 - 15 (without parentheses in this specification)).

[0004] As can be understood, FIG. 1 shows a cross - section of a human male abdomen (30). The valve (1) can generally be placed upstream of the pendulous urethra (27), generally at the bulge (17) within the bulbous urethra (26) of the patient, in view 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 states 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 hereby as Figure 2 for ease of reference. The document describes an intraurethral magnetic valve (1) for insertion into the urethra of a person suffering from incontinence. The intraurethral magnetic valve (1) includes 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, restrained position relative to the valve seat (4) by attraction to the ferromagnetic ring (5), thereby restricting the flow of fluid through the valve (1). The external magnet is used to apply 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 its closed, restrained position on the valve seat (4).

[0007] This document also teaches a second embodiment of the intraurethral magnetic valve (1) that includes a mechanism having a spring for releasing excess fluid pressure, in which case, if excess hydrostatic pressure is present, the valve seat assembly (36) is not attached to the housing (2) but is axially slidable within the housing against the force of the spring, allowing the fluid to be released through a passage around the valve seat assembly (36).

[0008] Such advanced intraurethral magnetic valves seek 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 can be brought close to an internally mounted intraurethral magnetic valve, resulting in the valve's operation from a closed configuration to an open configuration.

[0009] However, these urethral magnetic valves also have problems. For example, between the outer portion of the catheter and the wall of the urethra, the valve may exhibit poor sealing around the catheter. If poor sealing exists in this area, the valve will function correctly to block the flow of fluid through it unless it is then activated in an open configuration, but fluid may leak around the catheter, especially if the fluid pressure is relatively high.

[0010] The environment in which the valve, catheter, and their retaining mechanisms are positioned may contain hard deposits, such as calcified biofilms of Proteus mirabilis or other microbial materials. This can lead to valve blockage or affect the seal between the catheter and the urethral wall (which can lead to leakage, as described above).

[0011] The placement of urethral valves is also a subject of development. In particular, systems for the placement of urethral valves need to 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 guidance through the urethra. Typically, such placement systems require a part that is operated by a practitioner (e.g., a surgeon or other medically qualified person), and therefore this part does 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 retaining mechanism after the valve has been placed. Thus, a placement system for urethral valve devices needs to be able to guide the valve, catheter, and their retaining mechanism into place through the urethra and to be at least partially removable following such placement.

[0012] 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 urethral valve positioned at one end of the catheter. The system also includes a tool having a tip member that extends into an opening at the first end of the catheter and engages the tool with 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 that engages with a second end of the catheter. The tool is fitted to apply stress to the catheter using the element, thereby stiffening the catheter along its length. Stiffening the catheter facilitates its implantation in the urethra by allowing tensile, pushing, and torque forces.

[0013] 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 being fitted to extend from its distal end to its proximal end within the lumen of a tubular structure, the distal end of the reinforcing member being at least partially within the distal end of the tubular structure, 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 without the reinforcing member, and being axially displaceable within the tubular structure relative to the tubular structure, and (b) an engagement device for the reinforcing member extending into the lumen of a tubular structure, The engaging device comprises an engaging device that, in its engaged state, releasably engages a reinforcing member with a tubular structure, so that, as a result, one or both of the axial and radial displacements of the reinforcing member with respect to the tubular structure are substantially eliminated while the tubular structure is inserted into the internal passage, and in its disengaged state, disengages the reinforcing member from the tubular structure, so that, as a result, the reinforcing member is displaceable at least axially within the lumen of the tubular structure, and is adapted to be at least withdrawn from the tubular structure such that the proximal end of the reinforcing member is within or adjacent to the distal end of the tubular structure.

[0014] As can be understood from the aforementioned literature, these systems for the placement of urethral valves are relatively complex, and there is a general desire to simplify these systems. [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 Initiative] [Problems that the invention aims to solve]

[0016] As is understood, the placement of valve devices within a patient's urethra (male or female) can be uncomfortable. Valve devices compress the urethral wall due to the need to form a seal (see Figure 1, for example). Furthermore, external forces can increase discomfort. For example, when a patient sits, walks, runs, or climbs stairs, additional and / or different forces may be acting on the valve, catheter, and / or retaining mechanism. These changes in forces can alter the pressure exerted on the urethral wall and surrounding tissues by the valve, catheter, and / or retaining mechanism. This can increase the discomfort felt by the patient (in fact, a patient may simply feel uncomfortable when performing certain activities, especially when sitting, for example). Therefore, there is a need to improve the overall comfort of such valve devices during use. These and other issues were considered in the significant advances of Patent Document 5. However, despite these advances, there is still a continuing demand for further advances and improved solutions to these and other issues related to intraurethral devices such as valve devices. [Means for solving the problem]

[0017] overview One aspect of the present invention provides an intraurethral device comprising: a valve configured to be operated between an open and closed state 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 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 the first circumferential annular ring has a first outer diameter or outer thickness, and the second circumferential annular ring has a second outer diameter or outer thickness, and the first and second outer diameters or outer thicknesses are different from each other.

[0018] At least two circumferential annular rings may include a third circumferential annular ring, the first circumferential annular ring may be arranged spaced apart from the valve with respect to the second circumferential annular ring, the third circumferential annular ring may be arranged towards the valve with respect to the second circumferential annular ring, the second circumferential annular ring may be between the first circumferential annular ring and the third circumferential annular ring, and the third circumferential annular ring may have a third outer diameter or outer profile thickness that may be different from the second outer diameter or outer profile thickness.

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

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

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

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

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

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

[0025] Each circumferential annular ring may be provided on the same tubular collar.

[0026] One or more circumferential annular rings may be provided on a tubular collar different from one or more other circumferential annular rings.

[0027] Each circumferential annular ring may include an annular groove, and 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 to switch between an open configuration and a closed configuration; a catheter coupled to the valve in fluid communication, wherein the actuation of the valve controls the flow of fluid through the catheter; and a sealing member comprising a tubular collar and a first circumferential annular ring extending from the tubular collar, the first circumferential annular ring comprising a plurality of teeth.

[0029] The tooth portion extends radially and is angled relative to the longitudinal axis of the tubular collar and / or catheter.

[0030] Each tooth portion may include a conical or frustoconical portion separated from the tubular collar and / or catheter.

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

[0032] The apparatus may further include another tubular collar and a second circumferential annular ring extending from the other tubular collar, the second circumferential annular ring including 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 catheter coupled to the valve in fluid communication, wherein the actuation of the valve controls the flow of fluid through the catheter; and a sealing member formed at least partially from a thermoplastic elastomer.

[0034] The thermoplastic elastomer may be styrene-ethylene-butylene-styrene.

[0035] Another aspect of the present invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet to switch between an open configuration and a closed configuration; a catheter coupled to the valve in fluid communication, wherein the actuation of the valve controls the flow of fluid through the catheter; and a sealing member having an outer wall that at least partially defines a chamber configured to be at least partially inflated, the chamber being at least partially filled with a foaming material.

[0036] Another aspect of the present invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet to switch between an open configuration and a closed configuration; a catheter connected to the valve in fluid communication, wherein the operation of the valve controls the flow of fluid through the catheter; and an expandable portion formed in the wall of the catheter by a plurality of annular wavy portions, the expandable portion being compressible and expandable by bending of the catheter wall around the annular wavy portions.

[0037] The annular wavy portions may form a series of annular regions with increased outer diameters, with annular regions with reduced outer diameters in between.

[0038] The expandable portion may be configured to expand radially under the force of fluid pressure within the catheter, helping to seal the catheter against the urethral wall during use.

[0039] Another aspect of the present invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet to switch between an open configuration and a closed configuration; a catheter coupled to the valve in fluid communication, wherein the operation of the valve controls the flow of fluid through the catheter; a retaining mechanism coupled to the catheter, the retaining mechanism configured to deploy within the bladder; and a bladder seal or funnel portion coupled to the retaining mechanism, configured to direct fluid from the bladder to the catheter and / or to prevent the movement of fluid from the bladder through the urethra around the catheter.

[0040] The bladder seal or funnel portion may include an annular wall extending outward from the catheter and coupled to one or more arms or loops of the retention mechanism.

[0041] The annular wall can form a disk.

[0042] The disk may be connected to one or more loops or arms by one or more supports.

[0043] The annular wall can form a funnel-shaped section.

[0044] Another aspect of the present invention provides an intraurethral device comprising: a valve configured to be actuated by an external magnet to switch between an open configuration and a closed configuration; a catheter coupled to the valve in fluid communication, wherein the actuation of the valve controls the flow of fluid through the catheter; a spiral projection extending along the length of the catheter to provide a meandering passage for the flow of fluid around the catheter; a mesh-like projection extending along the length of the catheter to provide a meandering passage for the flow of fluid around the catheter; and a plurality of dot projections extending radially and provided along the length of the catheter to provide a meandering passage for the flow of fluid around the catheter, wherein the dot projections have a diameter, and the spacing between adjacent dot projections is less than their diameter.

[0045] 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 catheter coupled to the valve in fluid communication, wherein the actuation of the valve controls the flow of fluid through the catheter; a retaining mechanism coupled to the catheter, the retaining mechanism configured to unfold in the bladder; and a sheath configured to cover at least a portion of the retaining mechanism during insertion of the device into the urethra.

[0046] The sheath may be dissolvable or absorbable in the urethra and / or bladder after the device has been fitted.

[0047] The features and advantages of the claimed subject matter will become apparent from the following detailed description of embodiments consistent therewith, which should be considered with reference to the attached drawings. [Brief explanation of the drawing]

[0048] [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 is a diagram showing 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 6a] This figure shows views of several versions of the sealing member. [Figure 6b] This figure shows views of several versions of the sealing member. [Figure 7a] This figure shows views of several versions of the sealing member. [Figure 7b] This figure shows views of several versions of the sealing member. [Figure 8a] This figure shows views of several versions of the sealing member. [Figure 8b] This figure shows views of several versions of the sealing member. [Figure 9] This figure shows views of several versions of the sealing member. [Figure 10] This figure shows views of several versions of the sealing member. [Figure 11] This figure shows three versions of a device with expandable parts and / or sealing members. [Figure 12a] This figure shows one of three versions of the expandable portion and / or sealing member. [Figure 12b]This figure shows one of three versions of the expandable portion and / or sealing member. [Figure 12c] This figure shows one of three versions of the expandable portion and / or sealing member. [Figure 13] This figure shows a version with a bladder seal or funnel section. [Figure 14] This figure shows a version with a bladder seal or funnel section. [Figure 15] This figure shows another version with a bladder seal or funnel section. [Figure 16] This figure shows another version with a bladder seal or funnel section. [Figure 17] This figure shows a version with a meandering channel configuration in the shape of spiral protrusions. [Figure 18] This figure shows a version with a meandering channel configuration in the shape of spiral protrusions. [Figure 19] Another version is shown, featuring a meandering channel configuration with a mesh-like structure of protrusions. [Figure 20] Another version is shown, featuring a meandering channel configuration with a mesh-like structure of protrusions. [Figure 21] This figure shows another version with a meandering channel configuration in the shape of dot protrusions. [Figure 22] This figure shows another version with a meandering channel configuration in the shape of dot protrusions. [Figure 23] This figure shows a device with a sheath in several versions. [Figure 24] This diagram shows the valve ends in several versions. [Modes for carrying out the invention]

[0049] For a complete understanding of this disclosure, reference should be made to the following detailed description, including the accompanying claims and in relation 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 is understood that various omissions and substitutions of equivalents will be considered where circumstances suggest or where convenience may be warranted. Detailed explanation In summary, the present invention is generally directed toward intraurethral devices equipped with a unique valve. Various versions of intraurethral devices are shown and referred to in Figures 3-24 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.

[0050] As an example, with respect to Figures 4 and 5 (which are diagrams 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 that defines an internal valve volume, on which a spherical magnetic valve element 112 (hereinafter, "valve element 112") is arranged. 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] The ferromagnetic member 115 may be a continuous ring of ferromagnetic material. Therefore, the ferromagnetic member 115 may be generally tubular in shape. In some versions, the ferromagnetic member 115 may be ring-shaped in that it does not have to be a complete ring formed by the ferromagnetic material, but may form a ring-shaped structure formed from multiple segments of ferromagnetic material.

[0055] The ferromagnetic member 115 may have a first end that faces the internal volume when inside the valve 11, and a second end that is spaced 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, intersecting the length of the ferromagnetic member 115 (the length parallel to the longitudinal axis of the valve 11 when the ferromagnetic member 115 is positioned inside the valve 11).

[0056] The ferromagnetic member 115 can be coupled to the valve body 111, which can be achieved in several different ways.

[0057] 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. Thus, 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 elastically deforming and the width of the internal valve volume (in the direction of the force) being reduced. In other words, the body 111 may be resilient to the compressive forces it may be subjected to.

[0058] 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 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).

[0059] In some versions, the ferromagnetic member 115 may be fixed in place within the valve body 111 by interference fit. In such versions, the valve body 111 is formed separately from the ferromagnetic member 115, and a recess for receiving the ferromagnetic member 115 may be defined by the valve body 111. The ferromagnetic member 115 is then inserted into the recess and may 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 elastomer material used for the valve body 111) may be used to fix the ferromagnetic member 115 in place or to assist in fixing it. The plug is positioned toward the outlet port 114 of the valve 11 and, in fact, defines the outlet port 114, and the plug may be annular in shape, for example, having the outlet port 114 defined by the plug.

[0060] In some versions, the ferromagnetic member 115 may be attached to a spigot member of the valve body 111. The spigot member may define a passage through which the ferromagnetic member 115 can slide along the spigot member to a predetermined position. Next, a plug of material may be fitted onto the ferromagnetic member 115. The plug of material may generally be annular in shape.

[0061] In some versions, an adhesive may be used to fix the ferromagnetic member 115 to the valve body 111, or to assist in fixing it. In some versions, it will be understood that the spigot member may be part of the valve body 111, and similarly, a plug of material may form part of the valve body 111.

[0062] In some versions, the valve body 111 may be tubular in shape with one open end and a ferromagnetic member 115 positioned at the opposite end (the opposite end may generally be narrower in width than the open end, forming an outlet). The open end may be configured to be attached to the other 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 the inlet port 113 of the valve 11. Thus, the valve element 112 may be positioned within the valve body 111 via its open end before being coupled to the other part of the body 111 and / or the end of the catheter 12 (the other part of the 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., body 111), bonded thereto, or connected using a coupling process (e.g., insert molding).

[0063] 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, to allow the insertion of the valve element 112 in this manner.

[0064] 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.

[0065] The portion of the valve seat 116 configured to contact the valve element 112 may have a radius that matches or substantially matches 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.

[0066] In some versions, a separate ferromagnetic member 115 may not be used. For example, the valve seat 116 may be formed from an elastomer (e.g., silicon) containing a filler such as small steel or iron spheres or powder. In some versions, the ferromagnetic member 115 is provided as a separate component from the valve seat 116, but is itself formed from an elastomer (e.g., silicon) containing a filler such as small steel or iron spheres or powder.

[0067] 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.

[0068] 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 may be defined by the ferromagnetic ring 5, and the fluid passing through there may come into contact with, for example, the ferromagnetic ring 5 (or at least a portion thereof). In these versions, the valve seat 4 may be formed by the material covering the end face at the first end of the ferromagnetic ring 5.

[0069] In some versions, for example with respect to Figure 5, 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 by the material covering the end face of the first end of the ferromagnetic member 115.

[0070] In some versions, a separate valve seat member is provided to form the valve seat 116. This separate valve seat member may be positioned at the first end of the ferromagnetic member 115, adjacent to the end face, 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 between the valve element 112 and the valve seat 116 (compared to using the material of the valve body 111 for the valve seat 116). In some versions, the valve seat member may improve the stiffness (consistency) in forming the valve seat 116 (again, compared to using the material of the valve body 111 for the valve seat 116). The valve seat member may be formed of silicon with a different durometer than the valve body 111 (which may also be formed of silicon).

[0071] Device 1 (for example, using valve 11) can be operated between an open configuration and a closed configuration (for example, by an external magnet, the external magnet being outside of device 1 and, if attached to a person's body, outside the person's body to which device 1 is attached). In the open configuration, the valve element 112 is separated from the valve seat 116, and fluid can flow around the valve element 112 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 from fluid communication with the inlet port 113.

[0072] As can be understood, the valve element 112 can be biased toward a closed configuration by magnetic attraction to the ferromagnetic member 115. Furthermore, if the device 1 (e.g., valve 11) is placed 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 as a result, the fluid flow through the valve 11 may also help bias the valve element 112 toward a closed configuration.

[0073] The operation of valve 11 to an open configuration can be achieved by the use of a magnetic member. The magnetic member is placed outside the patient to which valve 11 is attached and moved relatively close to valve 11 to achieve operation from a closed configuration to an open configuration (by exposing valve 11 to the magnetic field of the magnetic member).

[0074] Actuation to a closed configuration can be achieved by the magnetic attraction between the valve element 112 and the ferromagnetic ring 115, and can be facilitated, for example, by gravity and / or the fluid flow through the valve 11.

[0075] The valve 11 described herein may be implanted in male or female patients as an intraurethral magnetic valve 11. Referring to Figure 1, the valve 11 described herein may replace valve (1) shown in Figure 1 and described in the reference from which the figure is cited (see above for details of the reference).

[0076] As described above, the valve 11 may be coupled to a catheter 12. The catheter 12 provides and defines a fluid flow path to the valve 11, in particular 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 in a desired position. Some versions may not include a retaining mechanism 14, and the catheter 12 and / or valve 11 may be held in place by their action against the urethra.

[0077] 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.

[0078] In some versions, the retaining mechanism 14 may include a Malecott, as shown in Figures 3, 6a, 6b, 7a, 7b, 8a, 8b, 9, 10, 11, and 15. 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. In this specification, arms, loops, or rings are examples of deployable members of the retaining mechanism 14, and this term will be used hereafter.

[0079] Therefore, in some versions, the device 1 is provided, which includes a valve 11, a catheter 12, and a retaining mechanism 14.

[0080] 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.

[0081] 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 stored to be substantially the same width as the catheter 12, for example). 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.

[0082] Therefore, as in Figure 1, the holding mechanism 14 may be located in the bladder neck, and the catheter 12 extends downstream of the urethra (with respect to the normal direction of fluid flow).

[0083] Several versions of valve 11 may be inserted or plugged in 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.

[0084] 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 of which are incorporated as a whole by reference.

[0085] The magnetic members may be, for example, those described 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.

[0086] Therefore, when in use, the device 1 can be positioned in the patient's bladder and urethra. In particular, the retaining mechanism 14 may be positioned in the bladder, the catheter 12 extending downstream through the urethra, and the valve 11 positioned along the length of the catheter 12, or at the end of the catheter 12 away from the retaining mechanism 14, or toward the end (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). sealing For valve 11 to be effective in controlling the flow of fluid (such as urine) through the urethra, the flow path of the fluid (or substantially all of that fluid) should be through catheter 12 and valve 11. Therefore, a good seal must be provided between catheter 12 and the urethra.

[0087] Therefore, in some versions (related to Figures 6-12), 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 catheter 12 (the length may be between the valve 11 and the retaining mechanism 14, i.e., upstream of the valve 11 with respect to the expected direction of urine flow). When multiple sealing members 15 are provided, more than one type of sealing member 15 may be provided, and multiple types of sealing members are described herein. At least one sealing member 15 may be positioned adjacent to the retaining mechanism 14.

[0088] In some versions, the sealing member 15 is a tubular collar 151 that fits around the length of the catheter 12. This tubular collar 151 is slid onto the catheter 12 and can be fixed in place by any suitable arrangement, such as welding or adhesive.

[0089] 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 outer circumference of the catheter 12. In some versions, the outer diameter of each of the plurality of circumferential annular rings 152 may be approximately 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 that tubular collar 151. Each circumferential annular ring 152 may have a cross-sectional profile that is rectangular or curved (for example, a cross-sectional profile obtained through the diameter of the circumferential annular ring 152, and considering one "end" of the ring 152 in such a cross-section) (see, for example, Figures 6a and 6b). Thus, each circumferential annular ring 152 may form a rib.

[0090] In some versions (see Figures 7a and 7b), the elongation (radial) distance (e.g., height) of the circumferential annular ring 152 varies along the length of the tubular collar 151, resulting in one circumferential annular ring 152 having a greater elongation height than another. In other words, the outer diameter of the circumferential annular ring 152 may differ between the circumferential annular rings 152 of the tubular collar 151 (referencing the relative diameter of the circumferential annular rings 152 should be considered herein equivalent to referring to the radial elongation height of the circumferential annular rings 152). This elongation distance may be measured relative to the tubular collar 151 (or multiple collars 151), but may be the elongation distance from the central axis of the catheter 12. In some versions, the outer diameter of the first circumferential annular ring 152 facing the retaining mechanism 14 is smaller than the outer diameter of the second circumferential annular ring 152 positioned further away from the retaining mechanism 14 (relative to the first circumferential annular ring 152). In fact, in some versions, the diameter of the circumferential annular rings 152 may increase with distance from the retaining mechanism 14. In some versions, the outer diameter of the circumferential annular rings 152 is maximum at a first distance from the retaining mechanism 14 and may 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, the outer diameters of the circumferential annular rings 152 taper equally to each other on either side of the circumferential annular ring 152 with the largest outer diameter. In some versions, the circumferential annular ring 152 with the largest diameter is positioned approximately in the center of the tubular collar 151.

[0091] In some versions, the elongation length of one circumferential annular ring 152 along the length of the tubular collar 151 and / or catheter 12 is different from that of another circumferential annular ring 152. In other words, the thickness (thickness along the length of the tubular collar 151 or catheter 12) may differ for each circumferential annular ring 152 (of the same device 1). This may therefore affect the degree of flexibility of the circumferential annular rings 152, which may vary along the length of the tubular collar 151 and / or catheter 12 (by variations in thickness, or by other means such as the use of different materials), and the flexibility of one circumferential annular ring 152 may differ from that of the other circumferential annular rings 152 or from that of each circumferential annular ring 152. In some versions, the flexibility decreases towards the retaining mechanism 14 or towards the valve 11. In some versions, the flexibility decreases towards the central circumferential annular ring 152, and then increases again (resulting in minimum flexibility at the central circumferential annular ring 152). In some versions, the flexibility increases towards the central circumferential annular ring 152, and then increases again (resulting in maximum flexibility at the central circumferential annular ring 152).

[0092] To ensure understanding, in some versions, the circumferential annular ring 152 or ring 152 may be described as a fin, respectively.

[0093] In some versions, each circumferential annular ring 152 includes a groove (see Figures 7a and 7b), which may be a circumferential groove. In some versions, the groove may be positioned around the centerline of each circumferential annular ring 152. Thus, the groove may define two circumferential portions with respect to each circumferential annular ring 152. Each of these two portions is generally annular. This arrangement allows the two portions to move relative to each other during insertion and removal of the catheter 12, assisting in the retention of the catheter 12 within the urethra. In some versions, more than one such groove may exist, and more than two portions may be defined.

[0094] In some versions, the thickness of the circumferential annular ring 152, or each circumferential annular ring 152, is greatest in the portion closest to the tubular collar 151 and / or catheter 12, and the thickness decreases as the circumferential annular ring 152 extends away from the tubular collar 151 and / or catheter 12. In other words, each circumferential annular ring 152 may taper (i.e., become thinner) as it extends away from the tubular collar 151 and / or catheter 12. As previously stated, the thickness of the circumferential annular ring 152 is the length along the tubular collar 151 and / or catheter 12 to which the circumferential annular ring 152 extends. This helps to facilitate the insertion of the device 1.

[0095] In some versions, each circumferential annular ring 152 has its own tubular collar 151, although the tubular collar 151 may be arranged to provide a corresponding arrangement of the circumferential annular rings 152, as described herein.

[0096] In some versions, each circumferential annular ring 152 is a nearly uniform ring with a constant or substantially constant radius. However, in some versions (see Figures 8a and 8b), each circumferential annular ring 152 may include one or more radially projecting projections or teeth such that the radius of the circumferential annular ring 152 varies around the circumference of the tubular collar 151. In fact, in some versions, each circumferential annular ring 152 is a ring of projections or teeth. Such projections may have rounded ends or pointed ends (so that they form teeth). In some versions, the projections or teeth may extend radially with respect to the tubular collar 151 and / or catheter 12. In some versions, the projections or teeth may be angled with respect to the longitudinal axis of the tubular collar 151 or catheter 12, so that they form barbs that resist movement of the collar 151 and / or catheter 12 away from the bladder. Therefore, this may help to hold the catheter 12 in place. In some versions, the circumferential annular rings 152 with projections or teeth are interspersed, with one or more circumferential annular rings 152 having a constant or substantially constant radius to assist in sealing. In some versions, the circumferential annular rings 152 including teeth or projections are provided on their own tubular collars 151, as described above. The teeth may have a generally triangular shape with a tip intended to contact the urethra. In some versions, the teeth are generally cylindrical projections extending substantially radially from the tubular collar 151 and / or catheter 12. In some versions, the ends of the cylindrical projections away from the tubular collar 151 and / or catheter 12 are tapered. In some such versions, each tooth may include a conical or frustoconical portion away from the tubular collar 151 and / or catheter 12.

[0097] 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 20 circumferential annular rings 152. In some versions, there are fewer than 15 circumferential annular rings 152.

[0098] In some versions (see Figure 9), the sealing member 15 includes at least a portion formed from a thermoplastic elastomer such as styrene-ethylene-butylene-styrene, which may be mixed with additives such as oil or fillers. The sealing member 15 formed from such material may or may not include a circumferential annular ring 152. The sealing member 15 formed from such material may be a tubular collar 151, or may include a tubular collar 151 as described herein. In some versions, the sealing member 15 formed from such material may increase in diameter as it extends from the retaining mechanism 14 to the maximum diameter portion. The sealing member 15 may decrease in diameter from the maximum diameter region toward the valve 11. The sealing member 15 may be configured to fit into the urethra after insertion (potentially during insertion) and provide a good seal between the urethra and the catheter 12.

[0099] In some versions (see Figure 10), the sealing member 15 may be in the form of a tubular collar 151, including an outer wall 153 with a diameter larger than the outer diameter of the catheter 12. The outer wall 153 may include an end joined (e.g., by the use of adhesive or welding) to the catheter 12 or the inner wall of the tubular collar 151 configured to fit around the catheter 12 (and which may be in contact with the catheter 12 along its length). Thus, in this form of the tubular collar 151, a chamber may be defined between the outer wall 153 and the inner wall or catheter 12. The chamber may be at least partially inflatable and sealed. In some versions, the chamber may be fluid-communicated with an expansion tube via a chamber valve located within the chamber, which may be a one-way valve (allowing fluid to flow into the chamber but preventing, or substantially preventing, the discharge of fluid from the chamber via an expansion tube). Therefore, in some versions, after insertion in a deflated state, the chamber may be inflated, at least partially, by allowing air or another fluid to pass through the expansion tube (or by injecting air or another fluid through the expansion tube). The expansion tube may be cut after insertion and inflation so that it does not protrude from the urethra.

[0100] In some versions, the chamber may be filled or partially filled with foam material. This may be an open-cell foam material. The foam material may facilitate the expansion of the chamber. For example, the foam material may be compressed during insertion and expanded during expansion.

[0101] In some versions, the expansion tube may not exist.

[0102] In some versions, the length of the catheter 12, which may be the length adjacent to the retaining mechanism 14, may include an expandable portion 16 (see, for example, Figures 11 and 12a-c). The expandable portion 16 may be formed from the wall of the catheter 12 and may have a series of annular undulations. The annular undulations of the wall of the catheter 12 may define an annular ring around which the wall of the catheter 12 may bend, and as a result, the expandable portion 16 may be compressed and expanded (for example, like a concertina). In some versions, the annular ring may be formed by a catheter wall that is at least partially thinner than the adjacent portion. Thus, the annular undulations may form a series of annular regions of enlarged outer diameter with annular regions of reduced outer diameter between them. In some versions, there may be two or more such regions of enlarged outer diameter. In some versions, there may be three or more such regions of enlarged outer diameter. In some versions, there may be five or more such regions of enlarged outer diameter. The length of the undulation along the catheter 12, and / or the diameter of the undulation, can be selected to achieve the desired degree of flexibility and expansion.

[0103] The expandable portion 16 may allow for changes in the length of the catheter 12 and / or may help ensure that the device 1 remains in place (i.e., is held). In some versions, the expandable portion 16 may also help provide a seal between the catheter 12 and the urethra. Thus, in some versions, the expandable portion 16 may also be considered a sealing member 15.

[0104] For example, the expandable portion 16 may be configured to expand radially under the action of fluid pressure within the catheter 12 (e.g., by the thickness and / or flexibility of the material used in this portion 16, and / or by the design of annular undulations). This can thus facilitate a seal between the catheter 12 and the urethra, in particular when the pressure of the fluid in the urethra (such as urine) is at its maximum.

[0105] When removing device 1, the expandable portion 16 may be stretched by a tensile force acting on device 1 (e.g., a manual removal force). This may stretch the expandable portion 16, which may have the effect of reducing its diameter, and thus may assist in the removal of device 1.

[0106] In some versions (see Figures 13–16), the device 1 may include a bladder seal or funnel member 141. The bladder seal or funnel member 141 may be configured to be positioned inside the bladder when fitted and may function to restrict or prevent the flow of fluid (e.g., urine) through the urethra around the catheter 12 (rather than through the catheter 12) and / or to deliver fluid (e.g., urine) into the catheter 12.

[0107] The bladder seal or funnel member 141 may be observed as part of (or coupled to) the retaining mechanism 14 and may be configured to act with the retaining mechanism 14 between a folded configuration and an extended configuration. Thus, the bladder seal or funnel member 141 may include an annular wall extending outward from the catheter 12. The wall may be connected to move with part of the retaining mechanism 14 (such as a loop or arm which may be part of the Malecot), and the operation of the retaining mechanism 14 between the contracted and extended configurations also results in the operation of the bladder seal or funnel member 141 between the contracted and extended configurations. This may assist in the insertion of the device 1 and may be achieved by the use of a guidewire of the device 1 (which, in this version and other versions, may be used to contract and extend the retaining mechanism 14).

[0108] The bladder seal or funnel member 141 may be funnel-shaped (see, for example, Figures 13 and 14), and its walls provide an annular surface that slopes toward the catheter 12 (in its normal orientation of insertion), directing the fluid (e.g., urine) toward the catheter 12.

[0109] The bladder seal or funnel member 141 may be disc-shaped (see, for example, Figures 15 and 16), and its walls may provide an annular surface extending radially from the catheter 12 (i.e., roughly perpendicular to the catheter 12). This version may provide an even greater sealing effect when positioned adjacent to the bladder neck.

[0110] As can be understood, in some versions, the bladder seal or funnel member 141 may be connected along the length of the arm or loop of the retaining mechanism 14, or coupled thereto via its respective post. The use of post 142 (which extends from the loop or arm to the wall of the bladder seal or funnel member 141) allows the angle of the wall of the bladder seal or funnel member 141 relative to the catheter 12 to be set by the length of post 142.

[0111] Such bladder seal or funnel member 141 may be provided in combination with any other version of the technology described herein. winding passage In some versions (see, for example, Figures 17–22), the tubular collar 151 may provide a meandering passage for fluid to pass through the urethra around the outside of the catheter 12 (the passage may be provided as a sealing member 15 or in addition to any other form of sealing member 15 described herein). In some versions, the catheter 12 itself may be configured to provide such a meandering passage, which may be provided in addition to another form of sealing member 15 described herein.

[0112] The configuration of the tortuous passage can be described with reference to the configuration provided by the catheter 12 itself, but the description will also be similar to the same configuration provided as part of the tubular collar 151, or in fact to several tubular collars 151 provided as part of the device 1.

[0113] In some versions, the meandering passage may be provided by a helical projection 121 (see, for example, Figures 17 and 18) extending around the length of the catheter 12. This helical projection 121 may be provided adjacent to the retaining mechanism 14 and / or adjacent to the valve 11. In some versions, the helical projection 121 may be provided along the entire length of the catheter 12, or substantially along the entire length, and in some versions, the sealing member 15 may be provided on at least a portion of the helical projection 121. The helical projection 121 may provide a passage for fluid (e.g., urine) from the bladder through the urethra, and the passage may be longer than it would otherwise be (e.g., longer than a direct path down the side of the catheter 12).

[0114] In some versions, the meandering passage may be provided by a mesh-like projection 122 that can provide a rhomboid mesh projection extending from the catheter 12 (for example, shown in Figures 19 and 20 as extending from the tubular collar 151 of the sealing member 15).

[0115] In some versions, the mesh projection 122 may be formed from an inflatable member having an outer wall that provides the mesh projection, or the mesh projection 122 may be provided on an inflatable tubular collar 151. This 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 projection 122 may be provided as a compressible foam material or elastomer, and the mesh projection 122 is deformable by contact with the urethra.

[0116] In some versions, the meandering passage may be provided by multiple dot projections 123 (see, for example, Figures 21 and 22). These dot projections 123 may extend radially from the catheter 12 and / or tubular collar 151. The dot projections 123 may be positioned close together. For example, the spacing between adjacent dot projections 123 may be smaller than the diameter of each dot projection 123 (for example, all dot projections 123 may have the same diameter).

[0117] The dot projections 123 may be provided adjacent to the retaining mechanism 14 and / or adjacent to the valve 11. In some versions, the dot projections 123 may be provided along the entire length of the catheter 12, or substantially along the entire length, and in some versions, the sealing member 15 may be provided on at least some of the dot projections 123. The dot projections 123 may provide a passage for fluid (e.g., urine) from the bladder through the urethra, and this passage may be longer than it would otherwise be (e.g., longer than a direct path down the side of the catheter 12).

[0118] The dot protrusions 123 may be formed from the same material as the catheter 12 if they are protrusions of the catheter 12, or from the same material as the tubular collar 151 if they are protrusions of the tubular collar 151.

[0119] In some versions, the features of a meandering passage (e.g., dot projections 123, spiral projections 121, and / or mesh projections 122, or any other suitable projections that form a meandering passage) may be formed during the molding process (e.g., when molding the catheter 12). In some versions, the features of a meandering passage may be provided by removing material from the catheter 12 or tubular collar 151 (e.g., cutting or grinding), or by a combination of molding and cutting. Insertion and removal In some versions, as can be seen in Figure 23 (which is a schematic diagram in the form of a cross-section, for example, where the valve 11 or catheter 12 is not shown in detail), the device 1 may be provided with a sheath 17. In some versions, the sheath 17 may be provided as a component of the intraurethral device 1, while in other versions, the sheath 17 may be considered to be provided separately from the device 1, as described herein.

[0120] In versions including sheath 17, sheath 17 may be provided to assist in insertion. Therefore, sheath 17 may be present during the insertion process and immediately after insertion, but sheath 17 may not be present for the majority of the device 1's lifespan (i.e., the time the device 1 is fitted to the patient and operating before final removal).

[0121] The sheath 17 may be configured to cover at least a portion of the retaining mechanism 14 (which may be the retaining mechanism 14 described herein, or several other retaining mechanisms not described herein). Thus, the retaining mechanism 14 may include, for example, a bladder seal or a funnel member 141.

[0122] The sheath 17 may be configured to help maintain some or more parts of the retaining mechanism 14 when the retaining mechanism 14 is in a non-deployed or retracted configuration (for example, before the retaining mechanism 14 changes to a deployed or extended configuration).

[0123] In some versions, the sheath 17 may be in the shape of a tube that fits 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 shape of a tube with 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 retaining mechanism 14 (relative to the retaining mechanism 14, the closed end may be farther away from the catheter 12). The closed end may be a sealed end or a substantially sealed end.

[0124] The sheath 17 may be formed from a flexible material or from a rigid material.

[0125] The sheath 17 may extend around all or part of the retaining mechanism 14 and around all or part of the catheter 12. In some versions, the sheath 17 may extend around all or part of the valve 11.

[0126] The sheath 17 may have an inner diameter smaller than the outer diameter of the retaining mechanism 14 when the retaining mechanism 14 is in its deployed configuration, and as a result, the sheath 17 may help to restrain the retaining mechanism 14 from deploying. In some versions, the retaining mechanism 14 is held in its non-deployed configuration by a guide wire or the like. Therefore, in some versions, the sheath 17 does not restrict the deployment of the retaining mechanism 14, but may function to assist the movement of the retaining mechanism 14 through the urethra (for example, by a lubricant or by a low coefficient of friction).

[0127] The sheath 17 may be coated with a lubricant and / or an antimicrobial and / or antibiotic material.

[0128] The sheath 17 may be formed from a soluble material. The material may be configured to dissolve in the patient's body (e.g., in the urethra and / or bladder). The sheath 17 may be formed from an absorbable material. The material may be configured to be absorbed into the patient's body.

[0129] In some versions, sheath 17 may be a woven structure formed from a soluble or absorbable material.

[0130] In some versions, the material used to form the sheath 17 may be the same as the material used for dissolvable sutures.

[0131] In some versions, sheath 17 is formed from a polysaccharide polymer such as pullulan, which can be formed into a thin film (which can now be used in breath strips and drug delivery).

[0132] In some versions, exposure to urine after (or during) insertion may aid in the dissolution and / or absorption of the sheath 17.

[0133] In some versions, the sheath 17 may be in the form of a tube with a closed end, the closed end may include one or more portions made of a soluble or absorbable material, and the rest of the sheath 17 may be formed of a material that is not readily soluble or absorbable, so that after insertion into the patient, one or more portions may be weakened and broken, and as a result the sheath 17 can be retrieved, for example, using one or more tethers extending from there out of the patient's body (device 1 is held in place in the fitting configuration). Thus, these portions allow the closed end to open (or open wide enough to pass through device 1).

[0134] In some versions, the sheath 17 may be configured to break or tear under the force of the retaining mechanism 14 changing to its deployed configuration. This may be the case in versions with or without the aforementioned soluble or absorbable material. The sheath 17 may thus have one or more weakening lines, points, or areas to enable or assist in the breaking or tearing of the sheath 17. The sheath 17 may be protected from premature breakage or tearing by, for example, a guidewire or other elements that maintain the retaining mechanism in its non-deployed configuration.

[0135] In some versions, the sheath 17 may be fitted onto the device 1 (or part thereof) by insertion of the device 1 (or part thereof) into the sheath 17. In some versions, the sheath 17 may be cast (in a mold) around the device 1.

[0136] Therefore, the sheath 17 can be considered part of the device 1, and the device 1 is prepared for insertion and potentially for post-insertion. However, the sheath 17 is intended to be removed for normal operation of the device 1. The sheath 17 may assist in the insertion of the device 1 into and through the urethra.

[0137] In some versions, the valve 11 may be part of the device 1, which is furthest from the retaining mechanism 14 (and therefore from the bladder when fitted). Therefore, to assist in the removal of the device 1, some versions may include a valve 11 with a tapered end face. Thus, when the device 1 moves out of the urethra, the tapered end face may be less likely to cause discomfort or injury compared to, for example, a sharp edge between the outer circumferential surface of the valve 11 (e.g., valve body 111) and the end face of the valve 11 (e.g., valve body 111). This is schematically shown in Figure 24 (for comparison, see the sharp edge at the end of the valve 11 in Figure 23).

[0138] As used herein and in the claims, the terms “contains” and “contains” and their variations mean that a particular configuration, step, or integer is included. These terms should not be construed as excluding the existence of other configurations, steps, or components.

[0139] The present invention may also broadly consist of parts, elements, steps, examples, and / or configurations that are individually referred to or shown herein, or collectively, any combination of two or more parts, elements, steps, examples, and / or configurations. In particular, one or more features of any embodiment described herein may be combined with one or more features of any other embodiment described herein.

[0140] Protection may be sought for any feature disclosed in one or more published documents referenced herein in conjunction with this disclosure.

[0141] Although specific exemplary embodiments of the present invention have been described, the appended claims are not intended to be limited to these embodiments only. The claims should be construed literally, in line with their purpose, and / or to encompass their equivalents.

[0142] 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.

[0143] The terms and expressions used herein are for illustrative purposes only, not for limitation, and in the use of such terms and expressions, there is no intention to exclude equivalents of the features (or parts thereof) illustrated and described, 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. Built-in 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 all purposes. Equal portions In addition to those shown and described herein, various modifications of the invention and many other embodiments thereof will be apparent to those skilled in the art from the entirety of this document, including references to the scientific and patent documents cited herein. The subject matter of this specification includes important information, examples, and guidance that can be applied to the practice of various embodiments of the invention and their 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, A catheter connected to the valve in fluid communication, wherein the operation of the valve controls the flow of fluid through the catheter, A urethral device comprising a sealing member including 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 the first circumferential annular ring has a first outer diameter or outer thickness, and the second circumferential annular ring has a second outer diameter or outer thickness, and the first outer diameter or outer thickness and the second outer diameter or outer thickness are different from each other.

2. An intraurethral device according to claim 1, wherein the at least two circumferential annular rings include a third circumferential annular ring, the first circumferential annular ring is positioned away from the valve relative to the second circumferential annular ring, the third circumferential annular ring is positioned toward the valve relative to the second circumferential annular ring, the second circumferential annular ring is located between the first circumferential annular ring and the third circumferential annular ring, and the third circumferential annular ring has a third circumferential diameter or thickness that is different from the second circumferential annular ring.

3. An intraurethral device according to claim 2, characterized in that the third outer diameter or outer thickness is the same as the first outer diameter or outer thickness.

4. An intraurethral device according to claim 3, characterized in that the third outer diameter or outer thickness is the third outer diameter, the first outer diameter or outer thickness is the first outer diameter, and the second outer diameter or outer thickness is the second outer diameter.

5. An intraurethral device according to claim 3, characterized in that the third outer diameter or outer thickness is the third outer thickness, the first outer diameter or outer thickness is the first outer thickness, and the second outer diameter or outer thickness is the second outer thickness.

6. An intraurethral device according to claim 1, characterized in that the first outer diameter or outer thickness is the first outer diameter, and the second outer diameter or outer thickness is the second outer diameter.

7. An intraurethral device according to claim 1, characterized in that the first outer diameter or outer thickness is the first outer thickness, and the second outer diameter or outer thickness is the second outer thickness.

8. An intraurethral device according to claim 1, wherein the sealing member comprises one or more other circumferential annular rings.

9. An intraurethral device according to claim 1, characterized in that each circumferential annular ring is provided on the same tubular collar.

10. An intraurethral device according to claim 1, characterized in that one or more circumferential annular rings are provided on a tubular collar that is different from one or more other circumferential annular rings.

11. An intraurethral device according to claim 1, characterized in that each circumferential annular ring is provided with an annular groove, and each circumferential annular ring has two circumferential portions.

12. 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, A urethral device comprising a sealing member comprising a tubular collar and a first circumferential annular ring extending from the tubular collar, wherein the first circumferential annular ring has a plurality of teeth.

13. An intraurethral device according to claim 12, characterized in that the teeth extend radially and are angled with respect to the longitudinal axis of the tubular collar and / or the catheter.

14. An intraurethral device according to claim 13, characterized in that each tooth portion comprises a conical or frustoconical portion separated from the tubular collar and / or the catheter.

15. An intraurethral device according to claim 12, further comprising a second circumferential annular ring extending from the tubular collar, wherein the second circumferential annular ring is provided with a plurality of teeth.

16. An intraurethral device according to claim 12, further comprising another tubular collar and a second circumferential annular ring extending from the other tubular collar, wherein the second circumferential annular ring is provided with a plurality of teeth.

17. 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, An intraurethral device characterized by comprising a sealing member formed at least partially from a thermoplastic elastomer.

18. An intraurethral device according to claim 17, characterized in that the thermoplastic elastomer is styrene-ethylene-butylene-styrene.

19. 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, An intraurethral device comprising: a sealing member having an outer wall that at least partially defines a chamber configured to be at least partially inflatable, wherein the chamber is at least partially filled with a foaming material; and the sealing member.

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, A catheter connected to the valve in fluid communication, wherein the operation of the valve controls the flow of fluid through the catheter, An intraurethral device characterized by comprising an expandable portion formed by a plurality of annular wavy portions on the wall of the catheter, wherein the expandable portion can be compressed and expanded by the bending of the wall of the catheter around the annular wavy portions.

21. An intraurethral device according to claim 20, characterized in that the annular wavy portion forms a series of annular regions with an increased outer diameter, each having an annular region with a reduced outer diameter in between.

22. An intraurethral device according to claim 17, characterized in that an expandable portion is configured to expand radially under the force of fluid pressure within the catheter, thereby assisting in sealing the catheter against the urethral wall during use.

23. 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, A retaining mechanism connected to the catheter, wherein the retaining mechanism is configured to deploy within the bladder, An intraurethral device comprising: a bladder seal or funnel portion coupled to the retaining mechanism and configured to direct fluid from the bladder to the catheter and / or to prevent the movement of fluid from the bladder through the urethra around the catheter.

24. An intraurethral device according to claim 23, wherein the bladder seal or funnel portion comprises an annular wall extending outward from the catheter and coupled to one or more arms or loops of the retaining mechanism.

25. An intraurethral device according to claim 24, wherein the annular wall forms a disc.

26. An intraurethral device according to claim 25, wherein the disc is connected to one or more loops or arms by one or more support columns.

27. An intraurethral device according to claim 24, wherein the annular wall forms a funnel.

28. 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, An intraurethral device comprising one or more helical projections extending along the length of the catheter to provide a meandering passage for fluid flow around the catheter; mesh-like projections extending along the length of the catheter to provide a meandering passage for fluid flow around the catheter; and a plurality of dot projections extending radially and provided along the length of the catheter to provide a meandering passage for fluid flow around the catheter, wherein the dot projections have a diameter, and the spacing between adjacent dot projections is less than their diameter.

29. 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, A retaining mechanism connected to the catheter, wherein the retaining mechanism is configured to deploy within the bladder, An intraurethral device comprising: a sheath configured to cover at least a portion of the retaining mechanism during insertion of the device into the urethra.

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