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WO2025134082A1 - Régulation du passage de l'urine dans l'urètre - Google Patents

Régulation du passage de l'urine dans l'urètre Download PDF

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Publication number
WO2025134082A1
WO2025134082A1 PCT/IB2024/063089 IB2024063089W WO2025134082A1 WO 2025134082 A1 WO2025134082 A1 WO 2025134082A1 IB 2024063089 W IB2024063089 W IB 2024063089W WO 2025134082 A1 WO2025134082 A1 WO 2025134082A1
Authority
WO
WIPO (PCT)
Prior art keywords
free end
appliance
conveyance
urethra
magnetic force
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/063089
Other languages
English (en)
Inventor
Jacob HASKI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Yachad ShSTR Ltd
Original Assignee
Yachad ShSTR Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Yachad ShSTR Ltd filed Critical Yachad ShSTR Ltd
Publication of WO2025134082A1 publication Critical patent/WO2025134082A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0022—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed deep in the body opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
    • A61F2/0018—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body magnetic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K31/00—Actuating devices; Operating means; Releasing devices
    • F16K31/02—Actuating devices; Operating means; Releasing devices electric; magnetic
    • F16K31/06—Actuating devices; Operating means; Releasing devices electric; magnetic using a magnet, e.g. diaphragm valves, cutting off by means of a liquid
    • F16K31/0644—One-way valve
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K31/00—Actuating devices; Operating means; Releasing devices
    • F16K31/02—Actuating devices; Operating means; Releasing devices electric; magnetic
    • F16K31/06—Actuating devices; Operating means; Releasing devices electric; magnetic using a magnet, e.g. diaphragm valves, cutting off by means of a liquid
    • F16K31/08—Actuating devices; Operating means; Releasing devices electric; magnetic using a magnet, e.g. diaphragm valves, cutting off by means of a liquid using a permanent magnet
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K31/00—Actuating devices; Operating means; Releasing devices
    • F16K31/02—Actuating devices; Operating means; Releasing devices electric; magnetic
    • F16K31/06—Actuating devices; Operating means; Releasing devices electric; magnetic using a magnet, e.g. diaphragm valves, cutting off by means of a liquid
    • F16K31/08—Actuating devices; Operating means; Releasing devices electric; magnetic using a magnet, e.g. diaphragm valves, cutting off by means of a liquid using a permanent magnet
    • F16K31/084—Actuating devices; Operating means; Releasing devices electric; magnetic using a magnet, e.g. diaphragm valves, cutting off by means of a liquid using a permanent magnet the magnet being used only as a holding element to maintain the valve in a specific position, e.g. check valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/047—Urethrae

Definitions

  • 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.
  • 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.
  • 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.
  • the magnetic force can be applied by a magnet adapted therefor and disposed extracorporeally.
  • 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.
  • 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.
  • the biasing force is effective to return the free end to the closed position upon removal of the magnetic force.
  • the flat coil spring can be integrally formed with a member of the fluid conveyance.
  • a method 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.
  • 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.
  • the extracorporeal applying of the magnetic force can include extracorporeally positioning a magnet adapted therefor.
  • the method can additionally comprise: removing the magnetic force to allow the biasing force to reposition the free end to the closed position.
  • a method 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.
  • the deploying of the urethral catheter at the second time is in the absence of the attractive magnetic force.
  • a method 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Fig. 4A is a schematic illustration of a flat coil spring having a three-dimensional free end, according to embodiments of the present invention.
  • Fig. 4B is a schematic illustration of a gasket for use in an implantable appliance, according to embodiments of the present invention.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Subscripted reference characters 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • free end means the portion of the flat coil spring extending outwardly from the coil portion.
  • 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.
  • 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.
  • 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’).
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a method 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:
  • Step SOI includes implanting, in the urethra 40, the appliance 100 as described in any one or more of the embodiments disclosed herein.
  • the appliance 100 is implanted in a portion of the urethral plenum 41 at least partly surrounded by the urinary sphincter muscle 20.
  • the appliance 100 is implanted in a minimally invasive procedure, e.g., in an endoscopic procedure.
  • 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.
  • 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.
  • the method additionally includes Step S03:
  • 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.
  • the method comprises the two method steps Sil and S12:
  • 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.
  • 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.
  • 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.
  • 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.
  • Step Sil and Step S12 are carried out at different times.
  • a method for regulating downstream passage of urine 97 through a urethra 40.
  • 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.
  • the method comprises at least the method step S21:
  • 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.
  • the method additionally includes Step S22:
  • 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.
  • the method additionally includes Step S23:
  • 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.
  • Steps S21, S22 and S23 are all carried out at different times.
  • an extension tube can be implanted in order to place the appliance 100 in communication with the bladder 10 through the extension tube.
  • the extension tube can comprise a hydrophobic material such as, e.g., polytetrafluoroethylene (PTFE).
  • PTFE polytetrafluoroethylene
  • the extension tube can be connected to the implanted appliance using a flare, such as, e.g., a conic flare.
  • 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.
  • An appliance for regulating downstream passage of a fluid 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Inventive concept 10 The method of Inventive concept 9, wherein the appliance is implantable and is implanted in an endoscopic procedure.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Urology & Nephrology (AREA)
  • General Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Mechanical Engineering (AREA)
  • External Artificial Organs (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un appareil intra-urétral implantable permettant de réguler le passage en aval de l'urine à travers l'urètre. L'appareil comprend un transport de fluide doté d'au moins une surface interne plane, le système de transport étant formé et dimensionné pour être implanté dans l'urètre, par exemple, pour être entourée par le muscle sphincter. Un ressort hélicoïdal plat est disposé à l'intérieur du moyen de transport sur la surface interne plane, une extrémité libre du ressort s'étendant en amont de l'enroulement et étant sollicitée dans une direction aval vers une position fermée bloquant le transport. L'extrémité libre est constituée d'un matériau ferromagnétique et peut ainsi être repositionnée par une force magnétique appliquée de l'extérieur vers une position ouverte dans laquelle le transport n'est pas complètement bloqué.
PCT/IB2024/063089 2023-12-21 2024-12-22 Régulation du passage de l'urine dans l'urètre Pending WO2025134082A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB2319721.3A GB2636761A (en) 2023-12-21 2023-12-21 regulation of the passage of urine through a urethra
GB2319721.3 2023-12-21

Publications (1)

Publication Number Publication Date
WO2025134082A1 true WO2025134082A1 (fr) 2025-06-26

Family

ID=89768065

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2024/063089 Pending WO2025134082A1 (fr) 2023-12-21 2024-12-22 Régulation du passage de l'urine dans l'urètre

Country Status (2)

Country Link
GB (1) GB2636761A (fr)
WO (1) WO2025134082A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5004454A (en) * 1989-02-15 1991-04-02 Technion Research And Development Foundation Ltd. Auxiliary intra-urethral magnetic valve for persons suffering from urinary incontinence
US5366506A (en) * 1993-04-05 1994-11-22 Davis Phillip J Proximity intraurethral valve using permanent magnet check
WO2022153064A1 (fr) * 2021-01-18 2022-07-21 Steaton Limited Perfectionnements apportés ou se rapportant à des systèmes de gestion de fluide

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10295713A (ja) * 1997-04-23 1998-11-10 Honda Seiki Kk 人工尿道バルブ及びその保持器具
US9622848B2 (en) * 2011-02-23 2017-04-18 Boston Scientific Scimed, Inc. Urethral stent system and method
DE102017115288A1 (de) * 2017-01-16 2018-07-19 Friedrich-Alexander-Universität Erlangen-Nürnberg Künstlicher Schließmuskel

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5004454A (en) * 1989-02-15 1991-04-02 Technion Research And Development Foundation Ltd. Auxiliary intra-urethral magnetic valve for persons suffering from urinary incontinence
US5366506A (en) * 1993-04-05 1994-11-22 Davis Phillip J Proximity intraurethral valve using permanent magnet check
WO2022153064A1 (fr) * 2021-01-18 2022-07-21 Steaton Limited Perfectionnements apportés ou se rapportant à des systèmes de gestion de fluide

Also Published As

Publication number Publication date
GB202319721D0 (en) 2024-02-07
GB2636761A (en) 2025-07-02

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