Regulation of the passage of urine through a urethra

Abstract

An implantable intraurethral appliance is provided for regulating downstream passage of urine through a urethra. The appliance comprises a fluid conveyance having at least one internal planar surface, the conveyance shaped and sized for implantation in the urethra, e.g., to be surrounded by the urinary sphincter muscle. A flat coil spring is disposed within the conveyance on the internal planar surface, a free end of the spring extending upstream of the coil and biased in a downstream direction to a closed position blocking the conveyance. The free end comprises a ferromagnetic material and thus is repositionable by an externally applied magnetic force to an open position in which the conveyance is not completely blocked.

Description

[0001] REGULATION OF THE PASSAGE OF URINE THROUGH A URETHRA

[0002] CROSS REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to UK patent application GB2319721.3, titled ‘Regulation of the passage of urine through a urethra’ and filed on December 21, 2023, the teachings of which are incorporated herein in their entirety.

[0004] FIELD OF THE INVENTION

[0005] The present invention relates to regulating passage of urine through a human urethra, and in particular to dual-mode intraurethral devices and methods operable magnetically and mechanically.

[0006] BACKGROUND

[0007] Artificial urinary sphincters of various designs are frequently implanted in order to prevent involuntary leakage of urine via the urethra, often in the case of a dysfunctional urinary sphincter. However, these designs do not provide solutions for persons who cannot exercise the urinary sphincter, such as, for example, persons suffering from various degrees of paralysis. Instead, such persons are largely limited to using urethral catheters to release the build-up of urine in the bladder. In addition to the medical and social drawbacks, the exclusive use of single-use catheters creates large amounts of waste and can be prohibitively expensive.

[0008] In the past, designs for a magnetically operated device for regulating urine flow have been proposed but not widely used. A drawback of such designs is a lack of a fallback mode, e.g., in the case of a magnet not being available to operate the device. In particular, a device designed to open ‘downstream’, i.e., away from the bladder in the direction of urine flow, is not readily adaptable to incorporate a fallback mode which may require deploying a foreign element such a catheter in an upstream direction. Another drawback of such designs is that manipulation of the magnet may be required for reclosing the opening mechanism of such an appliance.

[0009] Therefore, there is a need for an intraurethral device that can be conveniently operated to allow urine flow through the urethra on demand while offering a fallback mode that obviates dependence on a particular activation element such as an extracorporeal magnet. Further, there is a benefit in having such a device physically defaulting to returning to a closed position when an actuation mechanism, e.g., an extracorporeally positioned magnet, is removed. Moreover, it would be desirable for such a device to be useful not only in replacing the exercising of the urinary sphincter in order to release urine, but also for preventing involuntary leakage of urine.

[0010] SUMMARY

[0011] According to embodiments of the invention, an implantable appliance for regulating downstream passage of urine through a urethra comprises: (a) a fluid conveyance comprising an internal planar surface and shaped for implantation in the urethra; and (b) a flat coil spring disposed within the conveyance on the internal planar surface, a free end of the spring extending upstream of the coil and biased in a downstream direction to a closed position in which the free end is effective to block the conveyance. The free end comprises a ferromagnetic material so as to be repositionable to an open position in which the conveyance is not completely blocked, by an application of an attractive magnetic force sufficient to overcome a biasing force of the flat coil.

[0012] In some embodiments, the magnetic force can be applied by a magnet adapted therefor and disposed extracorporeally.

[0013] In some embodiments, the appliance can additionally comprise a gasket installed within the conveyance wherein, in the closed position, and the biasing force can be effective to maintain a seal between the gasket and at least a portion of a periphery of the free end.

[0014] In some embodiments, the free end can be repositionable to the open position, e.g., in the absence of the magnetic force, by advancing, in an upstream direction, a urethral catheter through the conveyance.

[0015] In some embodiments, it can be that the biasing force is effective to return the free end to the closed position upon removal of the magnetic force.

[0016] In some embodiments, the flat coil spring can be integrally formed with a member of the fluid conveyance.

[0017] In some embodiments, the appliance can be provided in a kit additionally comprising a magnet adapted for applying the magnetic force.

[0018] A method is disclosed, according to embodiments, for regulating downstream passage of urine through a urethra. The method comprises: (a) implanting, in the urethra, the appliance according to any one of the foregoing embodiments; and (b) extracorporeally applying the attractive magnetic force to overcome the biasing force and to reposition the free end to the open position.

[0019] In some embodiments, the appliance can be implanted in a portion of the urethra at least partly surrounded by a urinary sphincter muscle. In some embodiments, the appliance can be implanted in an endoscopic procedure.

[0020] In some embodiments, the extracorporeal applying of the magnetic force can include extracorporeally positioning a magnet adapted therefor. In some embodiments, the method can additionally comprise: removing the magnetic force to allow the biasing force to reposition the free end to the closed position.

[0021] A method is disclosed, according to embodiments, for regulating downstream passage of urine through a urethra in which the appliance of any one of the foregoing embodiments is implanted in the urethra. The method comprises: (a) at a first time, extracorporeally positioning a magnet to apply an attractive magnetic force to overcome the biasing force to reposition the free end to the open position; and (b) at a second time that is not the first time, deploying a urethral catheter to mechanically overcome the biasing force to reposition the free end to the open position.

[0022] In some embodiments, it can be that the deploying of the urethral catheter at the second time is in the absence of the attractive magnetic force.

[0023] A method is disclosed, according to embodiments, for regulating downstream passage of urine through a urethra having implanted therewithin an appliance comprising a fluid conveyance and a flat coil spring installed within the conveyance on an internal planar surface thereof, a free end of the spring extending upstream of the coil and biased in a downstream direction to block the conveyance, the free end comprising a ferromagnetic material, the method comprising: extracorporeally positioning a magnet to apply an attractive magnetic force to overcome a biasing force of the spring so as to reposition the free end to an open position in which the conveyance is not completely blocked.

[0024] In some embodiments, the method can additionally comprise: removing the magnet to allow the biasing force to reposition the free end to a closed position in which the conveyance is blocked. In some embodiments, the method can additionally comprise: deploying a urethral catheter to mechanically overcome the biasing force to reposition the free end to the open position.

[0025] BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The invention will now be described further, by way of example, with reference to the accompanying drawings, in which the dimensions of components and features shown in the figures are chosen for convenience and clarity of presentation and not necessarily to scale. In the drawings:

[0027] Figs. 1A and IB are respective schematic perspective and end views of an implantable appliance for regulating downstream passage of urine through a urethra, according to embodiments of the present invention.

[0028] Fig. 2 is a partial and schematic cross-sectional view of the appliance of Fig. 1A showing details of a flat coil spring disposed within the fluid conveyance with the free end of the spring biased to a closed position, according to embodiments of the present invention.

[0029] Fig. 3A is a schematic cross-sectional view of the appliance of Fig. 1A showing the free end of the spring, in the closed position, contacting a gasket disposed within the fluid conveyance, according to embodiments of the present invention.

[0030] Fig. 3B illustrates, within the cross-sectional view of Fig. 3 A, the repositioning of the free end of the spring to an open position using the attractive magnetic force of an external magnet, according to embodiments of the present invention.

[0031] Fig. 4A is a schematic illustration of a flat coil spring having a three-dimensional free end, according to embodiments of the present invention.

[0032] Fig. 4B is a schematic illustration of a gasket for use in an implantable appliance, according to embodiments of the present invention.

[0033] Fig. 4C is a schematic cross-sectional view of an implantable appliance incorporating the flat coil spring of Fig. 4A and the gasket of Fig. 4B, according to embodiments of the present invention.

[0034] Fig. 5 A is a schematic cross-sectional view of the appliance of Fig. 3 A implanted in the urethra of a subject, showing the free end of the spring in the closed position,, according to embodiments of the present invention. Fig. 5B is a schematic cross-sectional view of the appliance of Fig. 3 A, implanted in the urethra of a subject, showing the free end of the spring repositioned to the open position by the presence of an extracorporeal magnet, according to embodiments of the present invention.

[0035] Fig. 6 is a schematic illustration of a kit comprising the appliance of Fig. 1A and the magnet of Fig. 4B, according to embodiments of the present invention.

[0036] Fig. 7 is a schematic cross-sectional view illustrating the deployment of a urethral catheter to reposition the free end of the spring to the open position in the absence of a magnet, according to embodiments of the present invention.

[0037] Figs. 8 A, 8B, 9, 10A, 10B and 10C show flowcharts of methods and method steps for regulating downstream passage of urine through a urethra, according to embodiments of the present invention.

[0038] DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0039] The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. Throughout the drawings, like-referenced characters are generally used to designate like elements. Subscripted reference characters (e.g., 10i) may be used to designate multiple separate appearances of elements of a single species, whether in a drawing or not; for example: 10i is a single appearance (out of a plurality of appearances) of element 10. The same elements can alternatively be referred to without subscript (e.g., 10 and not 10i) when not referring to a specific one of the multiple separate appearances, i.e., to the species in general.

[0040] Some exemplary embodiments of the invention relate to an implantable appliance for regulating the flow in a urethra and methods for its use. The methods include, inter alia, operation of the appliance, implantation in a urethra and in situ operation of the appliance. The intraurethral appliance of the present embodiments comprises a fluid conveyance having an internal element spring-biased to a closed, blocking position. The internal element extends upstream and the biasing is in the downstream direction. Specifically, the biasing is effective to close the conveyance and block the flow of fluid, i.e., urine, from flowing further downstream through the urethra. The biasing is further effective to allow the conveyance to be reclosed simply by removing a magnetic or mechanical activation device following its use.

[0041] While the following description and attached drawings describe the exemplary related to regulating the flow in a urethra and methods for its use, some embodiments of the invention relate to an implantable appliance for regulating flow of a fluid in a body lumen, comprising a fluid conveyance having an internal element spring-biased to a closed, blocking position. The biasing is effective to close the conveyance and block the flow of fluid from flowing further downstream through the lumen. The biasing is further effective to allow the conveyance to be reclosed simply by removing a magnetic or mechanical activation device following its use. Further, some embodiments of the invention relate to an appliance for regulating flow of a fluid, comprising a fluid conveyance having an internal element spring-biased to a closed, blocking position. The biasing is effective to close the conveyance and block the flow of fluid from flowing further downstream. The biasing is further effective to allow the conveyance to be reclosed simply by removing a magnetic or mechanical activation device following its use.

[0042] According to some of the embodiments disclosed herein, the directionality of the internal element enables opening of the channel in either one of two non-overlapping modes: magnetically and mechanically. In a first mode, a magnet positioned externally to the subject’s body can overcome the biasing force of the spring and force the internal element to an open position - where the open position is any position where the fluid conveyance is not completely blocked by the internal element. Thus, an ‘open position’ as the term is used herein can also mean ‘a partly open position’ or ‘a not completely closed position’, the only criterion being that a fluid can flow past the internal element and downstream therefrom, either through the urethral lumen or through a catheter inserted therethrough. When the magnet is removed, e.g., distanced from its position, the spring bias returns the internal element to the closed position blocking the fluid flow through the conveyance. The second mode is intended to be exercised, although not exclusively, in the absence of the magnet. Depending on individual user preferences, the magnet may be preferred by a user because of the relative ease and convenience of use, as well as less material (e.g., plastic) waste and handling. The second mode involves using a mechanical force rather than a magnetic force to overcome the biasing force and to force the internal element to an ‘open position’. The mechanical force can be embodied by deployment of a urethral catheter, e.g., a single-use catheter, advanced in an upstream direction to push open the internal element and to push past it (up to and / or into the bladder) to allow fluid flow through the catheter along the length of the urethra. Should a magnet be forgotten or misplaced, for example, simply accessing a urethral catheter, e.g., from a personal supply or from a nearby pharmacy, can easily relieve the pressure of urine buildup in the bladder.

[0043] The terms ‘upstream’ and ‘downstream’ as used herein and in the appended claims are used relative to the regular direction of flow of urine from the bladder and through the urethra; the directions are illustrated by arrows in the relevant figures.

[0044] The dual-mode regulation of urine flow overcomes the shortcomings of current approaches both for people for whom voluntary exercise of the urinary sphincter muscle is not possible, e.g., because of partial paralysis, and for people suffering from involuntary urine leakage. It should be noted that the embodiments are relevant to both male and female persons, mutatis mutandis, despite the fact that some of the figures are specifically illustrative of male anatomy, e.g., showing the presence of a prostate.

[0045] Referring to the figures and in particular to Figs 1 A and IB, an implantable intraurethral appliance, shown schematically as appliance 100, is shaped and sized for implantation in a human urethra. An example of the appliance 100 being shaped and sized for implantation in a human urethra is a cylindrical shape with an outer diameter of 7 to 10 mm, or up to 20% more or less, and in some embodiments an outer diameter of 8 to 9 mm, or up to 10% more or less. The length of the appliance 100 can be in the range of 15 to 50 mm, or 20 to 40 mm, or 25 to 35 mm, and in some implementations longer or shorter. In a non-limiting and illustrative example, an appliance having an outer diameter of 9 mm and a length of 30 mm is employed. In some additional examples, the appliance is cigar shaped, e.g., thinner at one or both ends, and in other examples has an oval or elliptical cross-section.

[0046] The appliance comprises a fluid conveyance 110 with a curved outer surface 115 having at least one internal surface 120 that is planar, i.e., flat. In the illustrative example of Figs. 1A and IB, the conveyance 110 is shown having four internal surfaces 120 that are planar, but in other examples, not all of the four internal surfaces 120 are planar. In one example (not shown), only a first internal surface 120i is planar and the remaining surfaces 120 can be curved, or even shaped to form, in combination, a single continuous curved surface like a C-shape or a U-shape, opposite the planar surface 120i.

[0047] In some embodiments, as shown in the non-limiting example of Figs. 1A and IB, the outer surface 115 of the fluid conveyance 110 can be shaped to have roughness features such as grooves 118 and / or ridges (not shown). The roughness features when implemented are effective to inhibit or prevent rotation of the appliance 100 within the urethra. As will be discussed hereinbelow, a first mode of operation of the appliance 100 depends upon external placement of a magnet, and preventing rotation of the appliance can be desirable to ensure that repeated positioning of the magnet in the same location remains effective.

[0048] The fluid conveyance 110 can be formed from one or more biocompatible materials such as, without limitation, a biocompatible metal (or metal alloy) such as titanium or aluminum , a biocompatible polymer such as polypropylene, or any combination thereof. The fluid conveyance 110 can be produced in any suitable process such as, and not exhaustively: three-dimensional printing, electro-erosion, molding or machining.

[0049] We now refer to Fig. 2, a partial cross-sectional view of the appliance 100 of Fig. 1 A. This view reveals a spring-biased internal element in the form of a flat coil spring 150 disposed, e.g., attached or integrally formed therewith, on the planar surface 120i. The flat coil spring is a preferred example of a spring-biased internal element, but other configurations are included within the scope of the invention; for example, a separate plate member joined to a free end of a regular coil spring can be arranged in the same way and with the same functionality as the flat spring coil of Fig. 2.

[0050] It should be noted that the planar surface 120i is shown on the ‘bottom’ of the figures in the drawings but this is only for convenience and easy understanding of the drawings, and in fact the planar surface 120i might be in any orientation in accordance with a subject’s anatomy. The orientation of the cross-section of the appliance 100 of Fig. 2 is chosen in order to show the details of the spring-biased internal element, i.e., the flat spring coil 150.

[0051] The term ‘free end’ as used herein and in the appended claims means the portion of the flat coil spring extending outwardly from the coil portion. As shown, e.g., in Fig. 2, the ‘free end’ 155 of the spring 150 is arranged to extend in the upstream direction from the main coil 152, and is biased in the downstream direction to a closed position. As can be understood from the cross-sectional view of Fig. 2, the closed position is one in which the free end 155 of the spring 150 blocks the internal plenum of the fluid conveyance 110 to prevent the flow or leakage of fluid, i.e., urine, downstream from the free end 155. The free end 155 is suitably formed to have a shape matching the contour of the internal surfaces 120 of the fluid conveyance 110, for example, square as in Fig. 1A or C-shaped in the alternative example discussed hereinabove. In embodiments, the free end 155 is itself formed of a ferromagnetic material or alternatively incorporates a ferromagnetic component, such as, for example, a ferromagnetic insert 159.

[0052] We now refer to Figs. 3A and 3B. Fig. 3A shows an example of an appliance 100 in which a gasket 140 (also shown in Fig. 1 A) is disposed or installed within the fluid conveyance 110. As shown in Fig. 1 A, the gasket 140 can be disposed on all of the internal surfaces 120 of the fluid conveyance 110 except the planar surface 120i on which the coil spring 150 is disposed. In other examples (not illustrated), in which the spring- biased internal element is configured differently than the flat spring coil 150 of Figs. 3 A and 3B, the planar surface 120i can also be gasketed. As can be understood from Fig. 3A, a primary purpose of the gasket 140 is to improve the seal made between a peripheral edge 153 of the free end 155 and the internal surfaces 120 of the fluid conveyance 110. The seal is enhanced by the biasing force of the spring 150 pressing the periphery 153 against the gasket 140. It should be noted that the downstream length of the gasket 140 as shown, e.g., in Figs 3A and 3B, is not important, and can be shorter than that shown depending on the material and the manner of attachment or installation. The material of the gasket 140 can be any biocompatible polymer, and most likely one that is less hard than the interior surface 120 of the fluid conveyance 110 which can comprise a metal and / or a polymer, so as to provide a better seal. As schematically illustrated in Fig. 3B, an appropriately placed magnet 200 can be used to provide an attractive magnetic force 195 capable of overcoming the biasing force of the coil spring 150, repositioning the free end 155 to an open position, as the term has been defined hereinabove, and as illustrated by arrow 900 showing the maximum travel path of the free end 155 as it is repositioned (the travel path can be less since, as discussed above, the ‘open position’ does not necessarily mean ‘open all the way’).

[0053] Figs. 4A, 4B and 4C show an exemplary design of certain components of the implantable appliance 100. Fig. 4A is a schematic illustration of a coil spring 150 having a three-dimensional free end 155 for enhanced mechanical stability and rigidity. In the non-limiting example of Fig. 4A, the coil spring 150 is integrally formed with the adjacent internal planar surface 120i. A ferromagnetic portion can be provided, e.g., integrated, with this coil spring designed, but is not shown in Fig. 4A. Fig. 4B shows an exemplary gasket 140 designed to pair with the coil spring 150 of Fig. 4A. When the coil spring 150 of Fig. 4A is biased to the closed position, the open flow window 141 of the gasket 140 is closed by the presence of the downstream wall 158 of the coil spring 150. Fig. 4C is a schematic cross-sectional view of the coil spring 150 of Fig. 4A and the gasket 140 of Fig. 4B incorporated in an implantable appliance 100. Fig. 4C shows the open flow window 141 of the gasket 140 seated on the downstream wall 158 of the coil spring 150.

[0054] The function of the appliance 100 in a first mode of activation to magnetically unblock (open) the fluid conveyance 110 is illustrated in situ in Figs. 5 A and 5B. The urinary system (for convenience, of a male person) is illustrated as comprising a bladder 10 and a urethra 40, showing the urethral lumen 41 in cross-section. The appliance 100 is shown as implanted downstream of the bladder 10 and of the prostate 12, and at least partly or mostly surrounded by the urinary sphincter muscle 20. The repositioning of the free end 155 from blocking the fluid conveyance 110 is effective, according to embodiments relating to use by persons unable to exercise the urinary sphincter muscle 20, to cause the release of urine through a downstream end of the urethra 40 without exercising the urinary sphincter muscle 20. In the case of persons suffering from involuntary urine leakage, the repositioning of the free end 155 from blocking the fluid conveyance 110 is effective to allow urine to flow after having been blocked when the free end 155 was in the closed position.

[0055] Said repositioning of the free end 155 of the flat spring coil 150 is accomplished, in the example of Fig. 5B, by the extracorporeal positioning of a magnet 200 adapted for the purpose, providing an attractive magnetic force (shown in Fig. 3B). Magnetically repositioning the free end 155 depends both on the suitability of the magnet 200 and on its positioning. The term ‘extracorporeal’ as used herein means outside the subject’s body such that the wall of the urethra and the skin of the subject are between the magnet 200 and the flat spring coil 150. ‘Extracorporeal positioning’ of the magnet 200 means that the magnet 200 is located in proximity to the skin 30 and approximately opposite the flat spring coil 150 and the ferromagnetic portion 159 in a location similar to that illustrated in Fig. 5B, where the attractive magnetic force 195 is effective to cause repositioning of the free end 155.

[0056] The term ‘adapted for’ with respect to the magnet 200 means, inter alia, ‘sufficient to overcome a biasing force’, i.e., the magnet 200 is of appropriate size and strength to overcome the biasing force of the flat coil spring 150 when positioned extracorporeally in proximity to the skin 30 of the subject, e.g., in the direction indicated by Fig. 5B. Specifically, a magnet can be ‘adapted for’ the purpose by selecting a magnet either empirically, e.g., by testing the strength of the attractive magnetic force 195 with respect to repositioning a free end 155 comprising the ferromagnetic component 159, through tissue layers (real or emulated) of appropriate thicknesses, or analytically, by calculating or measuring the biasing force of the flat coil spring 150 and deriving therefrom the minimum parameters of the magnet 200 sufficient to overcome the biasing force to reposition the free end 155 in situ. Conversely, a magnet extracorporeally positioned as shown in Fig. 5B capable only of applying an attractive magnetic force 195 that is insufficient for the task would not be considered ‘adapted for’ the repositioning of the free end 155 to the open position.

[0057] In some embodiments, as illustrated in Fig. 6, an implantable, intraurethral appliance 100 according to the embodiments disclosed herein is provided, e.g., produced and / or sold in a kit 300 that includes, in addition to the appliance 100, one or more magnets 200 ‘adapted for’, i.e., shaped and sized for use in magnetically repositioning, e.g., in situ, the free end 155 of the flat spring coil 150 of the appliance 100. The function of the appliance 100 in a second mode of activation to mechanically unblock (open) the fluid conveyance 110 is illustrated in situ in Fig. 7. The free end 155 is configured to extend from the coil 152 in the upstream direction and to be biased by the spring-biasing force in the downstream direction, and thus can be repositioned (opened) mechanically, e.g., by being pushed to an open position by a catheter 90 inserted in the urethra 40 from the downstream end and advanced in the upstream direction until reaching the bladder 10. The urethral catheter 90, e.g., a single-use catheter, is then effective to drain urine 97 from the bladder 10 through the catheter 90. Fig. 7 shows an optional catheter bag 95 for drainage but depending on circumstances of use may not be required when using the catheter 90. In some embodiments, the second mode of activation, i.e., using a catheter (or other mechanical device) is particularly useful when the magnet 200 of the various embodiments is unavailable.

[0058] Referring now to Fig. 8 A, a method is disclosed for regulating downstream passage of urine 97 through a urethra 40. As illustrated by the flowchart in Fig. 8A, the method comprises at least the two method steps SOI and S02:

[0059] Step SOI includes implanting, in the urethra 40, the appliance 100 as described in any one or more of the embodiments disclosed herein. In some embodiments, the appliance 100 is implanted in a portion of the urethral plenum 41 at least partly surrounded by the urinary sphincter muscle 20. In some embodiments, the appliance 100 is implanted in a minimally invasive procedure, e.g., in an endoscopic procedure.

[0060] Step S02 includes extracorporeally applying an attractive magnetic force 195 to overcome the biasing force of the flat coil spring 150 and to reposition the free end 155 to the open position. In some embodiments, the extracorporeal applying of the magnetic force 195 includes extracorporeally positioning a magnet 200 adapted therefor as the expression is defined hereinabove, the positioning being, for example, as shown in Fig. 7.

[0061] In some embodiments, as illustrated by the flowchart in Fig. 8B, the method additionally includes Step S03:

[0062] Step S03 includes removing the magnetic force 195, e.g., distancing the magnetic force 195 from the appliance 100, to allow the biasing force to reposition the free end 155 to the closed position. In other words, all that is required to reclose the fluid conveyance 110 by blocking it with the free end 155 is to move the magnet 200 far enough away from its extracorporeal position. Referring now to Fig. 9, a method is disclosed for regulating downstream passage of urine 97 through a urethra 40. As illustrated by the flowchart in Fig. 9, the method comprises the two method steps Sil and S12:

[0063] Step Sil includes extracorporeally positioning a magnet 200 to apply an attractive magnetic force 195 to overcome the biasing force of the flat spring coil 150 to reposition the free end 155 to the open position. This step represents activating the appliance 100 magnetically, in the first mode of activation, as discussed hereinabove.

[0064] Step S12 includes deploying a urethral catheter 90 to mechanically overcome the biasing force to overcome the biasing force of the flat spring coil 150 to reposition the free end 155 to the open position. This step represents activating the appliance 100 mechanically, in the second mode of activation. In some embodiments, the deploying of the urethral catheter 90 at the second time is in the absence of the attractive magnetic force 195, i.e., in the absence of the magnet 200. For example, activating the appliance 100 can be a preferred mode for a user who cannot exercise the urinary sphincter 200, who deploys a catheter 90 only when the magnet 200 is not present.

[0065] According to the method, Step Sil and Step S12 are carried out at different times.

[0066] Referring now to Fig. 10A, a method is disclosed for regulating downstream passage of urine 97 through a urethra 40. According to the method, the urethra 40 has implanted therewithin an appliance 100 comprising a fluid conveyance 110 and a flat coil spring 150 installed within the conveyance 110 on an internal planar surface 120i thereof, a free end 155 of the spring 150 extends upstream of the coil 152 and is biased in a downstream direction to block the conveyance 110, and the free end 155 comprises a ferromagnetic material or component 159. As illustrated by the flowchart in Fig. 10A, the method comprises at least the method step S21:

[0067] Step S21 includes extracorporeally positioning a magnet 200 to apply an attractive magnetic force 195 to overcome a biasing force of the spring 150 so as to reposition the free end 155 to an open position in which the conveyance 110 is not completely blocked.

[0068] In some embodiments, as illustrated by the flowchart in Fig. 10B, the method additionally includes Step S22:

[0069] Step S22 includes: removing the magnet 200 to allow the biasing force to reposition the free end 155 to a closed position in which the conveyance 110 is blocked. In some embodiments, as illustrated by the flowchart in Fig. IOC, the method additionally includes Step S23:

[0070] Step S23 includes: deploying a urethral catheter 90 to mechanically overcome the biasing force so as to reposition the free end 155 to the open position.

[0071] In embodiments, Steps S21, S22 and S23 are all carried out at different times.

[0072] The steps of the various methods can be combined with any other method steps and carried out in any suitable order.

[0073] In some implementations of the embodiments, an extension tube can be implanted in order to place the appliance 100 in communication with the bladder 10 through the extension tube. In some embodiments, the extension tube can comprise a hydrophobic material such as, e.g., polytetrafluoroethylene (PTFE). In some embodiments, the extension tube can be connected to the implanted appliance using a flare, such as, e.g., a conic flare.

[0074] The skilled artisan will understand that the implantable appliance disclosed herein is suitable for and / or can be adapted for use in other applications, including other medical applications and other applications involving regulation of the flow of a fluid. In some examples, an appliance for other applications comprises a fluid conveyance having an internal element spring-biased to a closed, blocking position. The appliance can be implantable or designed for external use. The internal element of the element extends upstream and the biasing is in the downstream direction in terms of an existing and / or desired direction of flow of a fluid, e.g., through a body lumen, or other tube or pipe. The biasing is effective to close the conveyance and block the flow of the fluid from flowing further downstream. The biasing is further effective to allow the conveyance to be reclosed simply by removing a magnetic or mechanical activation device following its use. Features of the implantable appliances and methods for their use have largely been coached throughout the this disclosure in terms of urethral implantation and for regulating the flow of urine, but this is merely for convenience and clarity, and such features can be equally applied, mutatis mutandis, in other lumens and with other fluids. The designs and incentive concepts disclosed herein can also be applied to other applications for regulating flow of a fluid - for example, through a pipe where an electrically activated valve cannot be deployed, e.g., for safety reasons. The following paragraphs summarize additional inventive concepts disclosed herein.

[0075] Inventive concept 1. An appliance for regulating downstream passage of a fluid, the appliance comprising: a. a fluid conveyance comprising an internal planar surface and shaped for implantation in a body lumen, pipe, or tube; and b. a flat coil spring disposed within the conveyance on the internal planar surface, a free end of the spring extending upstream of the coil and biased in a downstream direction to a closed position in which the free end is effective to block the conveyance, wherein the free end comprises a ferromagnetic material so as to be repositionable to an open position in which the conveyance is not completely blocked, by an application of an attractive magnetic force sufficient to overcome a biasing force of the flat coil.

[0076] Inventive concept 2. The appliance of Inventive concept 1, wherein the magnetic force is applied by a magnet adapted therefor and disposed extracorporeally and / or outside the lumen, tube or pipe.

[0077] Inventive concept 3. The appliance of either one of Inventive concepts 1 or 2, additionally comprising a gasket installed within the conveyance wherein, in the closed position, the biasing force is effective to maintain a seal between the gasket and at least a portion of a periphery of the free end.

[0078] Inventive concept 4. The appliance of any one of the preceding Inventive concepts, wherein the free end is repositionable to the open position in the absence of the magnetic force by advancing, in an upstream direction, an elongated element through the conveyance.

[0079] Inventive concept 5. The appliance of any one of the preceding Inventive concepts, wherein the biasing force is effective to return the free end to the closed position upon removal of the magnetic force.

[0080] Inventive concept 6. The appliance of any one of the preceding Inventive concepts, wherein the flat coil spring is integrally formed with a member of the fluid conveyance.

[0081] Inventive concept 7. The appliance of any one of the preceding Inventive concepts, wherein the flat coil spring is integrally formed with at least a portion of the internal planar surface. Inventive concept 8. A kit comprising the appliance of any one of the preceding Inventive concepts, and additionally comprising a magnet adapted for applying the magnetic force.

[0082] Inventive concept 9. A method of regulating downstream passage of a fluid through a body lumen, tube or pipe, the method comprising: a. implanting, in the lumen, tube or pipe, the appliance of any one of Inventive concepts 1 to 8; and b. extracorporeally (or extra-luminally or otherwise externally to the lumen, tube or pipe) applying the attractive magnetic force to overcome the biasing force to reposition the free end to the open position.

[0083] Inventive concept 10. The method of Inventive concept 9, wherein the appliance is implantable and is implanted in an endoscopic procedure.

[0084] Inventive concept 11. The method of either one of Inventive concepts 9 or 10, wherein the extracorporeal or extra-luminal or external applying of the magnetic force includes extracorporeally or extra-luminally or otherwise externally positioning a magnet adapted therefor.

[0085] Inventive concept 12. The method of any one of Inventive concepts 9 to 11, additionally comprising: reducing the magnetic force to allow the biasing force to reposition the free end to the closed position.

[0086] Inventive concept 13. A method of regulating downstream passage of a fluid through a body lumen, tube or pipe, in which the appliance of any one of Inventive concepts 1 to 8 is deployed therein, the method comprising: a. at a first time, extracorporeally or extra-luminally or externally positioning a magnet to apply an attractive magnetic force to overcome the biasing force to reposition the free end to the open position; and b. at a second time, deploying an elongated element catheter to mechanically overcome the biasing force to reposition the free end to the open position.

[0087] Inventive concept 14. The method of Inventive concept 13, wherein the deploying of the elongated element at the second time is in the absence of the attractive magnetic force.

[0088] Inventive concept 15. A method of regulating downstream passage of a fluid through a lumen, tube or pipe having deployed therewithin an appliance comprising a fluid conveyance and a flat coil spring installed within the conveyance on an internal planar surface thereof, a free end of the spring extending upstream of the coil and biased in a downstream direction to block the conveyance, the free end comprising a ferromagnetic material, the method comprising: extracorporeally or extra-luminally or externally to the lumen, tube or pipe) positioning a magnet to apply an attractive magnetic force to overcome a biasing force of the spring so as to reposition the free end to an open position in which the conveyance is not completely blocked.

[0089] Inventive concept 16. The method of Inventive concept 15, additionally comprising: removing the magnet to allow the biasing force to reposition the free end to a closed position in which the conveyance is blocked.

[0090] Inventive concept 17. The method of Inventive concept 16, additionally comprising: deploying a catheter to mechanically overcome the biasing force to reposition the free end to the open position.

[0091] The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons skilled in the art to which the invention pertains.

Claims

CLAIMS1. An implantable appliance for regulating downstream passage of urine through a urethra, the appliance comprising: a. a fluid conveyance comprising an internal planar surface and shaped for implantation in the urethra; and b. a flat coil spring disposed within the conveyance on the internal planar surface, a free end of the spring extending upstream of the coil and biased in a downstream direction to a closed position in which the free end is effective to block the conveyance, wherein the free end comprises a ferromagnetic material so as to be repositionable to an open position in which the conveyance is not completely blocked, by an application of an attractive magnetic force sufficient to overcome a biasing force of the flat coil.

2. The appliance of claim 1, wherein the magnetic force is applied by a magnet adapted therefor and disposed extracorporeally.

3. The appliance of either one of claims 1 or 2, additionally comprising a gasket installed within the conveyance wherein, in the closed position, the biasing force is effective to maintain a seal between the gasket and at least a portion of a periphery of the free end.

4. The appliance of any one of the preceding claims, wherein the free end is repositionable to the open position in the absence of the magnetic force by advancing, in an upstream direction, a urethral catheter through the conveyance.

5. The appliance of any one of the preceding claims, wherein the biasing force is effective to return the free end to the closed position upon removal of the magnetic force.

6. The appliance of any one of the preceding claims, wherein the flat coil spring is integrally formed with a member of the fluid conveyance.

7. The appliance of any one of the preceding claims, wherein the flat coil spring is integrally formed with at least a portion of the internal planar surface.

8. A kit comprising the appliance of any one of the preceding claims, and additionally comprising a magnet adapted for applying the magnetic force.

9. A method of regulating downstream passage of urine through a urethra, the method comprising: a. implanting, in the urethra, the appliance of any one of claims 1 to 8; and b. extracorporeally applying the attractive magnetic force to overcome the biasing force to reposition the free end to the open position.

10. The method of claim 9, wherein the appliance is implanted in a portion of the urethra at least partly surrounded by a urinary sphincter muscle.

11. The method of either one of claims 9 or 10, wherein the appliance is implanted in an endoscopic procedure.

12. The method of any one of claims 9 to 11, wherein the extracorporeal applying of the magnetic force includes extracorporeally positioning a magnet adapted therefor.

13. The method of any one of claims 9 to 12, additionally comprising: reducing the magnetic force to allow the biasing force to reposition the free end to the closed position.

14. A method of regulating downstream passage of urine through a urethra in which the appliance of any one of claims 1 to 8 is implanted in the urethra, the method comprising: a. at a first time, extracorporeally positioning a magnet to apply an attractive magnetic force to overcome the biasing force to reposition the free end to the open position; and b. at a second time, deploying a urethral catheter to mechanically overcome the biasing force to reposition the free end to the open position.

15. The method of claim 14, wherein the deploying of the urethral catheter at the second time is in the absence of the attractive magnetic force.

16. A method of regulating downstream passage of urine through a urethra having implanted therewithin an appliance comprising a fluid conveyance and a flat coil spring installed within the conveyance on an internal planar surface thereof, a free end of the spring extending upstream of the coil and biased in a downstream direction to block the conveyance, the free end comprising a ferromagnetic material, the method comprising:extracorporeally positioning a magnet to apply an attractive magnetic force to overcome a biasing force of the spring so as to reposition the free end to an open position in which the conveyance is not completely blocked.

17. The method of claim 16, additionally comprising: removing the magnet to allow the biasing force to reposition the free end to a closed position in which the conveyance is blocked.

18. The method of claim 16, additionally comprising: deploying a urethral catheter to mechanically overcome the biasing force to reposition the free end to the open position.

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