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WO1999030635A1 - Appareil uretral muni d'une soupape grand debit et procedes d'utilisation dudit appareil - Google Patents

Appareil uretral muni d'une soupape grand debit et procedes d'utilisation dudit appareil Download PDF

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Publication number
WO1999030635A1
WO1999030635A1 PCT/US1998/026509 US9826509W WO9930635A1 WO 1999030635 A1 WO1999030635 A1 WO 1999030635A1 US 9826509 W US9826509 W US 9826509W WO 9930635 A1 WO9930635 A1 WO 9930635A1
Authority
WO
WIPO (PCT)
Prior art keywords
proximal
valve
bladder
bellows
distal
Prior art date
Application number
PCT/US1998/026509
Other languages
English (en)
Inventor
Lloyd K. Willard
Mark J. Whalen
Original Assignee
Abbeymoor Medical, Inc.
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 Abbeymoor Medical, Inc. filed Critical Abbeymoor Medical, Inc.
Priority to AU18227/99A priority Critical patent/AU1822799A/en
Publication of WO1999030635A1 publication Critical patent/WO1999030635A1/fr

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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

Definitions

  • the present invention relates generally to apparatuses for placement in the urethra and methods of using such apparatuses, and more particularly to apparatuses that can be positioned in the urethra for short-term or long-term use and that provide functions such as valving for flow control.
  • Urinary problems include urine retention, incontinence, and difficult urination Inability to evacuate retained urine may lead to damage of the epithelium and detrusor muscles associated with the urethra and to an increased potential for bacterial invasion and urinary tract infection Incontinence, which is the inability to retain urine because of the paralysis or relaxation of sphincter muscles or because of the contraction of longitudinal muscular layers of the bladder, is not only a social problem but also one of the leading causes of institutionalization of the elderly Difficult urination or dysuria can lead to problems similar to those of urine retention Devices have been developed and used in attempts to correct the problems of urine flow
  • One conventional device is the indwelling Foley catheter
  • the Foley catheter has an inflatable balloon attached at one end
  • the Folev catheter is positioned in the urethra with the proximal end in the bladder
  • the inflatable balloon is used to anchor the proximal end of the Foley catheter in the bladder Urine enters the Foley catheter through drainage holes which are located along
  • Figure 1 is an expanded elevational view of a present embodiment of an indwelling urethral device positioned within the bladder and urethra
  • Figure 2 shows a partial sectional view of the embodiment of Figure 1
  • Figure 3 is an expanded elevational view of the urethral device of Figure I positioned within the bladder and urethra shown in another stage of operation
  • Figure 4a is an expanded distal end view of the actuator rod of Figure 2
  • Figuie 4b is an expanded side view of the actuator rod of Figure 2
  • Figure 4c is a expanded proximal end view of the actuator rod of Figure 2
  • *> is an expanded elevational view of another alternate embodiment ot an indwelling ui ethral device
  • Figure 6 show s an expanded elevational v iew of another embodiment ol an indwelling urethral device positioned within the bladder and extending into the bladder neck and urethra.
  • Figure 7 shows a partial sectional view of the urethral device of Figure 6
  • Figure 8 shows a further expanded view of the proximal portion of the urethral device of Figures 6 and 7
  • Figure 9 shows an expanded partial sectional view of the urethral device of Figures 6, 7, and 8 and an external magnet causing the urethral device to be the in another stage of operation
  • Figure 10 shows a side view of a third embodiment of an indwelling urethral device.
  • Figure 1 1 is a sectional view of the proximal portion of the embodiment of Figure 10
  • Figure 12 is a sectional view of the proximal portion of a fourth embodiment of an indwelling urethral device
  • the first embodiment includes a urethral device and associated method of use that provide for the voluntary control of urine removal from the bladder of an individual who suffers from urinary incontinence or other urine-control problems
  • the individual may be either a male or female human, or alternatively, embodiments of the device may be used in other mammals or even other non-mammal animals with suitable changes in dimensions
  • the urethral device of the first embodiment is hydraulically activated
  • the device includes a pressure-sensitive actuator which is operated by voluntary application of pressure to the bladder region
  • the pressure can be either externally applied (e g pressing the abdomen in the region of the bladder with the fingers) or internally applied (e g contracting the muscles in the region of the bladder as one would do during normal urination)
  • the actuator requires the sustained application of pressure to the region of the bladder for a suitably long duration of time to open a valve to discharge urine from the bladder through the device This provides for the damp
  • the sealing rings 29 may be located along a proximal pan of the main po ⁇ ion 87 adjacent to the first casing 88
  • the sealing rings 29 are used to form a fluid barrier between the urethral device 10 and the urethra 4 to limit or reduce leakage of urine around the outside of the urethral device
  • the main po ⁇ ion 87 of the device 10 is produced using a composite construction of a base tube and cast external features
  • a base tube is constructed as a braid reinforced silicone tube using a stainless steel wire braid and Shore A 60 durometer silicone compound as the tube polymer (tubing produced by New England Electric Wire Corp Portugal)
  • the internal diameter of the base tube is 0 160 inches using a braid core diameter of 0.180 inches
  • the external diameter of the base tube is 0 210 inches
  • the urethral apparatus 10 has an overall length such that it resides entirely within the urinary tract of the patient, preferably primarily within the urethra, except to the extent to which the proximal end 13
  • the exterior distal shape of the plug 41 is slightly tapered so that an outer diameter of the plug 41 is less at its distal end than at its proximal end.
  • the exterior of the plug 41 may be tapered along its entire length (e.g., frusto-conical) or alternatively, the taper may begin at an intermediate location along the length of the plug.
  • the tapered, distally facing exterior surface of the plug 41 forms an angular flange 40
  • the angular flange 40 forms a proximal valve seat against which the ultrasoft ring 38 moves to form a seal to prevent fluid from entering into the proximal opening 39 defined by the ultrasoft ring 38
  • the bellows valve 42, and in particular the proximal end of the bellows valve 42, is displaceable along the axis 17
  • the bellows valve 42 may be formed of a spring 44 encapsulated by a very thin plastic sleeve or layer 45
  • the layer 45 may be composed of a suitably strong, yet flexible
  • the urethral device 10 is positioned in the urethra 4 Positioning may be accomplished using conventional techniques Alternatively, the urethral device may be positioned in the urethra using the techniques and/or equipment disclosed in the referenced copending application entitled “URETHRAL APPARATUS WITH POSITION INDICATOR AND METHODS OF USE THEREOF " After the urethral device 10 is successfully positioned in the urethra 4 of the individual, it is used to control urine flow from the bladder 1 When the urethral device 10 is in place and the pressure of the urine in the bladder is below a predetermined threshold for a predetermined period of time, unne is prevented from entering into the urethral device 10 by the seal formed by the annular ring 38 against the angular flange 40 Under these conditions the proximal spring 56 biases the domed retainer 54 in a proximal direction away from the barrier wall 64 causing the domed retainer 54 to be moved to a proximal position, as shown
  • the actuator rod 72 begins moving distally when sufficient pressure is applied against the proximal surface 74 of the disk 77 of the actuator rod 72 by the distal membrane 68 As fluid 58 continues to fill the distal reservoir 62, the distal membrane 68 continues to move distally, bearing against the proximal surface 74 of the disk 77 of the actuator rod 72 and causing the actuator rod 72 to move distally along the axis 17 Because the distal ring 78 of the actuator rod 72 is fixed to the annular ring 38, distal axial movement of the actuator rod 72 causes the annular ring 38 to likewise move distally.
  • the tubing 84 of the main body portion 87 of the urethral device is formed of a silicone tubing reinforced with a stainless steel wire-braid
  • the tubing has an outside diameter of approximately 5 3 mm ( 210 inches) and an inside diameter of approximately 4 1 mm ( 160 inches)
  • the length of the tubing is selected and/or varied to conform to the anatomical features of the individual in whom the device is positioned
  • the overall length can vary from less than 10 cm for male users to less than 5 cm for female users although lengths greater than these may be provided
  • the silicone material of the tubing is a blend of NuSil MED 41 15 and MED 41 16 in a 1 1 mix ratio to achieve a Shore A 60 durometer hardness
  • the stainless steel wire braid is 3 16L wire braided at 14 picks per inch 2 ends per carrier and 16 carriers using a braid core diameter of approximately 4 6 mm ( 180 inches)
  • the exterior features such as the anchors 27 used to anchor the device in the urethra and the sealing rings 29, are formed
  • the diameter of the domed retainer is approximately 4.3 mm ( 170 inches) 1
  • the proximal spring 56 may be composed of a compression spring formed from 302 stainless steel wire Its spring constant is approximately 19 25 N/m ( 1 1 lbf/in) using approximately 15 mm ( 006 inches) wire wound with 3 active coils and 2 dead coils
  • the proximal spring 56 is installed within the reservoir 60 formed by the 5 proximal membrane 52. The proximal membrane is sealed so that the spring is 6 preloaded to approximately 73 grams of force.
  • the geometry of the spring can be 7 varied to provide different spring constants that result in the domed retainer 54 moving 8 at different pressure thresholds 9
  • the proximal spring may be omitted in alternative () embodiments Among some patient populations, it may not be necessary to provide 1 the biasing force of the proximal spring and the device may be restored to a closed 2 position using the biasing force of the bellows spring alone 3
  • the fluid 58 performs the function of transferring the pressure acting on the 4 surface of the proximal membrane 52 to the surface of the distal membrane 68
  • the 5 fluid 58 is essentially incompressible
  • the fluid moves through the fluid passageway 6 66 in the barrier wall 64 to fill the distal reservoir 62
  • the diameter, length, entrance 7 angle and roughness of the fluid passageway 66 control the rate of fluid flow
  • the S viscosity of the fluid 58 also affects the flow rate.
  • the fluid mav be composed of 0 bio-compatible oils, for example, with viscosities higher than water, to achieve a 1 reduction in flow rate through the passageway 66
  • the barner plate 64 is made from 304 stainless steel and the passagewav 66 has a diameter of approximately 3 mm ( 013 inches) This diameter is sized to provide the desired amount of fluid volume through the orifice over a time period of approximately 3 seconds The range of orifice sizes can vary greatly to allow for various time damping effects to the distal po ⁇ ions of the device
  • the barrier plate 64 is formed of an injection-molded plastic pan with the passageway hole 66 formed using a secondary operation to ensure an accurate hole diameter size and burr-free construction.
  • the fluid passageway geometry and dimensions affect the performance characteristics of the passageway These aspects can be modified to tune the passageway performance to desired specifications
  • the outside perimeter surface of the barrier plate 64 is relieved to facilitate forming a seal with the extruded bag used to form the proximal and distal reservoirs
  • a two-piece construction may be used for the barrier plate 64
  • a relatively hard material whose dimensions can be precisely controlled, is used to form the fluid passageway 66, and another, softer material is used for the rest of the barrier plate 64.
  • a stainless steel tube can be used to provide the fluid passageway 66, and an outer ring of silicone rubber can be cast over the stainless steel tube to form the rest of the barrier plate 64
  • a two-piece embodiment of the barrier plate 64 provides the advantage that the outside po ⁇ ion can be formed of a more flexible material to facilitate placement and use of the device
  • the actuator rod 72 and the proximal disk 77 are formed from a 304 stainless steel wire and disk, respectively
  • the diameter of the wire is approximately 51 mm ( 020 inches) and the thickness of the disk is approximately 51 mm ( 020 inches)
  • the mounting flange 80 is formed of a sho ⁇ tubular section of medical grade polycarbonate In one embodiment, the mounting flange has an outside diameter of approximately 3 9 mm ( 154 inches) and an inside diameter of approximately 3 4 mm ( 134 inches)
  • the marker 90 is formed from a relatively radiopaque or acoustically opaque mate ⁇ al, such as a metal wire coil In one embodiment the marker 90 is formed using 304 stainless
  • the embodiments of the urethral device described above include several advantages One of the advantages is that the device is able to provide a fluid seal with a relatively very low force, for example less than approximately 8 grams This enables the device to use very low pressures in the bladder to accomplish fluid sealing This feature is provided by one or more of the following factors the ability of annular ring 38 to stretch and conform to the shape of the angular flange 40, the proximal profile of the annular ring 38 that is exposed to urine pressure, and the shape and material characteristics of angular flange 40 The ability of the annular ring 38 to stretch and conform is a function of both its material and design In one embodiment, the annular ring 38 is constructed of soft silicone rubber that allows the annular ring to stretch easily The wall thickness and length of the annular ring 38 also influence its stiffness and/or its ability to stretch The wall thickness of the annular ⁇ ng directly influences the stiffness of the ⁇ ng and the length of ring inversely influences its stiffness For example an annular ⁇ ng with a
  • the shape, cylindrical taper, and material characteristics of the angular flange 40 assist in minimizing the amount of sealing or axial force applied to the annular ring 38
  • the taper angle increases the normal force (or stretch force) component of the axial force applied to the annular ring 40 This increase in normal force increases the amount of friction between the annular ring 38 and the angular flange 40
  • the use of a low-friction material for the angular flange 40 reduces the amount of friction between the annular ring 38 and the angular flange 40
  • the reduction in friction force allows a greater po ⁇ ion of the axial force to be used to stretch the annular ring 38
  • Sealing an annular ring of the size disclosed above to an angular flange with a 15-degree taper requires approximately 1 to 2 grams of axial force to form a fluid-tight seal at approximately 70 cm of water pressure The ability to achieve a fluid-tight seal at this magnitude of axial force
  • the seal is further capable of sealing at pressures from approximately 0 cm to approximately 150 cm of H 2 0 which the bladder can generate.
  • the length of the angular flange 40 also influences the performance of the device. During initial distal movement of the annular ring 38, the angular flange 40 is in the urine flow. The length of the angular flange 40 influences how much travel is required by the annular ring 38 to clear the angular flange in order to achieve the desired flow rate. A short angular flange 40 improves device performance with regard to flow rate and magnitude of the annular ring displacement.
  • the ability of the bladder to produce sufficient pressure to initiate the drainage of urine is limited to voluntary control by the individual due to normal micturition urges, contractions, or external Crede methods.
  • This pressure which is externally applied to the bladder, is transformed into a force that can be used to place the device in an open condition by the separation of the annular ring 38 from the angular flange 40.
  • the force on the domed retainer 54 which has a diameter of approximately . 180 inch, were to transform a bladder pressure of 50 cm of water pressure completely to force, the device would generate 8.2 grams of force.
  • 8.2 grams of force would be the maximum amount of force available to open the system. This is a relatively small amount of force.
  • the device closes and, conversely, opens at forces of less than approximately 10 grams and preferably at forces less than approximately 5 grams
  • Another advantageous feature of the disclosed embodiment is the use of the flexible bellows valve.
  • the flexible bellows valve allows the proximal end of the annular ring 38 to be displaceable along the axis 17 without incurring substantial frictional losses inherent to other movable sealing methods (i.e., shaft seals).
  • the flow-control actuator components e.g., the fluid barrier plate and spring
  • the flow-control actuator components are not in the exit flow path of urine (via the drainage ports 16 in the first casing). This provides several advantages. First, encrustation on the actuation components is reduced since these critical components are not in the urine flow path. In addition, since these components are outside the flow path, the size of the flow path can be increased, thereby permitting 1 a high flow rate of urine through the device
  • FIG. 30 3 1 Alternative embodiment Figure 5 shows an alternative embodiment of the urethral device of Figure 1
  • the main portion 87 A includes seminal pons 97 These seminal po ⁇ s provide a relatively unobstructed pathwav for seminal fluids to pass from the seminal ducts to the urethra 4
  • the seminal ports 97 are formed by a stamping process that precisely locates and shapes them The size shape, and position of the seminal ports 97 can be configured to the anatomical requirements of the individual
  • FIG. 6-9 A second embodiment of an indwelling urethral device used to control urine flow in an individual is shown in Figures 6-9
  • the second embodiment includes some components which are similar to those in the first embodiment, and such similar components are indicated by the same numerals incremented by "200 "
  • the second embodiment differs from the first embodiment in that it uses a magnetic actuator assembly instead of a hydrau cally actuated assembly to control fluid access into the internal fluid-flow passageway of the device
  • a first magnet which is located external of the body of the individual in whom the device is positioned, is brought into proximity of the abdominal region of the individual close to the indwelling device
  • the magnetic field of the first magnet is used to rotate a second magnet located inside the indwelling intraurethral device
  • the second magnet effects operation of the valve of the indwelling intraurethral device to allow urine to flow through the device
  • the flow-control mechanism used in the second embodiment requires very little force tor activation and thus offers the advantage that the sizes of the sizes of the sizes of
  • urethral device 210 is positioned w ithin the bladder 201 the bladder neck 202 and urethra 204
  • the device 210 has a body 220 with a proximal po ⁇ ion 212 terminating at a proximal end 213 and with a distal po ⁇ ion 214 terminating at distal
  • the body 220 has a wall 222 with an external surface 224 and has a generally tubular shape around an axis 217
  • the cross-sectional shape of the body 220 mav be generally round or may be flattened to conform to the anatomical shape of urethra 204
  • the body 220 includes a 'ain po ⁇ ion 287 and a first casing 288
  • the first casing 288 has drainage po ⁇ s 216
  • the bellows valve 242 is connected at its proximal end to the annular ring 238 and is attached at its distal end to a mounting flange 280
  • the mounting flange 280 is connected to the first casing 288, as in the first embodiment
  • the bellows valve 242 is deformable in length along the
  • the distal pin 266 extends through the distal wall of the proximal cavity 226 into a flange cavity 271
  • the distal end of the distal pin 266 is connected at its distal end to a barrel cam 268 which is located in the flange cavity 271
  • a cam housing 270 is located in the flange cavity 271
  • a proximal end of the central shaft po ⁇ ion 273 of an actuator rod 272 extends into the flange cavity 271 through an opening centrally located in a distal wall of the flange cavity 271 (Unlike the actuator rod 72 in the first embodiment, the actuator rod 272 in the second embodiment does not include a proximal disk )
  • the central shaft po ⁇ ion 273 of the actuator rod 272 is slidable relative to the distal wall of the flange cavity 271
  • the cam housing 270 is connected at its distal end to the
  • the urethral device 210 is positioned in the urethra 204 using any of the techniques described above in connection with the first embodiment
  • Figure 6 shows the urethral device 210 after it has been positioned in the urethra
  • the urethral device 210 is in the closed position
  • urine is prevented from entering the urethral device 210 by the sealing of the inner surface of the annular ring 238 to the angular flange 240
  • an external actuation magnet 326 is positioned close to the urethral device 210.
  • the external magnet 326 is positioned within approximately five inches of urethral device 210 and approximately perpendicular to the axis 2 17
  • the internal magnet 291 of the urethral device 10 rotates because its south-poled surface 296 is magnetically attracted and drawn towards the no ⁇ h-poled surface 328 of the external actuation magnet 326
  • the speed of rotation of the internal magnet 291 is controlled by the viscosity of the fluid 295 in the sealed proximal cavity 226 and the clearance between the magnet 291 and the internal surface 227 of the second casing 289
  • the control of the rotation of magnet 291 provides a time delay mechanism in the device
  • the distal pin 266 of the internal magnet 291 is connected at its distal end to the ba ⁇ el cam 268 so that rotation of the internal magnet 291 results in similar angular displacement of the barrel cam 268
  • the distal cam face 277 of the barrel cam 268 slidably engages the follower 275, causing the cam housing 270 to displace the actuator rod
  • actuator rod 272 likewise causes the cam housing 270 to rotate the barrel cam 268
  • the angular flange 240 acts as a sealing surface to the annular ring 238
  • the proximal po ⁇ ion of the angular flange 240 is a stepped, 1 cylind ⁇ cal surface to interface with the bellows valve 242 and the bellows spring 244 2
  • the outer diameter of the angular flange is approximately 5 3 mm ( 210 inches ) and 3 3 8 mm ( 149 inches )
  • the internal follower is sized and shaped to cooperate with the 4 helix of barrel cam 268 5
  • the fluid 295 is preferably a medical grade glycerin with an ambient viscosity 6 of approximately 800 centi-poise at 70 degrees Fahrenheit The fluid 295 is retained
  • the flexible bellows valve 242 is constructed from a bellows spring 244 within
  • ⁇ > bellows spring 244 is formed from 302 stainless steel wire The spring constant of the
  • 24 bellows spring 244 is approximately 4 5 N/m ( 026 lbf/in) using an approximately 15
  • the bellows valve 242 may be constructed from Shore A 30 durometer 2S medical grade silicone rubbei ( I e NuSil MED 4-4220) In this construction the
  • 29 bellows valve 242 provides a sealed interface between the angular flange 240 and the
  • the bellows valve 242 is constructed with
  • the proximal pin 262 is formed from nonmagnetic.
  • Both the proximal journal 264 and distal journal 269 are cylindrical components made from a Teflon TFE and Acetal (Del ⁇ n AF) blend
  • the proximal journal 264 is press fit into the proximal wall of the second casing 289
  • the distal pin 266 is formed from a nonmagnetic, 304 stainless steel wire, approximately 020 inches in diameter Its length is sufficient to engage the barrel cam 268 in order to transmit rotation of the internal magnet 291 to the barrel cam
  • the barrel cam 268 is a cylindrical component with an external helix
  • the external helix acts as a guide rail upon which the follower 275 slides
  • the barrel cam is constructed from a Teflon TFE and Acetal (Del ⁇ n AF) blend
  • the barrel cam is press fit onto the distal end of distal pin 266
  • the internal magnet 291 is a Neodymium 45 ceramic material purchased from PERMAG, a division of Dexter Magnetic Materials, as pan number PN45C0140B magnet
  • the second embodiment includes many of the same advantages as the first embodiment
  • the magnetically actuated embodiment has its actuation components located outside the urine fluid flow path This provides the advantage that the dimensions of the urine fluid flow passageway can be relatively large thereby providing for a correspondingly high flow rate and relativelv complete voiding of the bladder This is advantageous for reducing discomfort and the risk of infection
  • One adv antage provided bv the magnetically actuated embodiment is that its operation is controlled bv the external magnet Therefore, the second embodiment would be useful for those individuals who might be unable to exe ⁇ the necessary muscular activity to operate the first embodiment
  • the external magnet is used to positively activate the device to effect voiding of the bladder Because of viscous shear damping effects created by the magnet 291 rotating in the fluid 295, the external magnet 326 is positioned in close proximity to the indwelling device for a preset duration of time, e g 3-5 seconds or more, to cause the device to open to let urine to flow through it This avoids unintentional
  • the opposing force provided by the latch spring 456 is relatively larger than the force provided by the bellows spring 444
  • the device opens to allow urine to flow from the bladder into the drainage po ⁇ s 416, through the device 410 out the body of the person in whom the device is positioned.
  • a substantially non- linear force opposing opening of the device results
  • the device is closed in a manner similar to the first embodiment
  • the flow through the device diminishes
  • the individual relaxes so that relatively high bladder pressure is not sustained
  • This has the effect of reducing the force applied to the proximal membrane 452 below the opposing force of the bellows spring 444
  • This causes the plunger 465 which is connected to the bellows, to move proximally and likewise causes the fluid 458 which had been in the distal reservoir 462 to flow to the proximal reservoir 460 through the opening 466
  • the latch sp ⁇ ng 456 engages the distal edge of the plunger 465 secu ⁇ ng it in the proximal position
  • the ring 438 is seated on the angular flange 440 and the device is sealed to prevent flow of urine
  • the latching mechanism is described as being formed of a latching spring
  • FIG. 12 A fou ⁇ h embodiment of an indwelling urethral device 610 used to control urine flow in an individual is shown in Figure 12
  • the components in the fou ⁇ h embodiment are similar or identical to those in the second embodiment, except as noted below
  • this embodiment includes a magnetic actuator and like the third embodiment, the embodiment of Figure 12 includes a latching mechanism that provides for a non-linear force which is required to be overcome to open the device to allow urine to be drained from the bladder
  • the fou ⁇ h embodiment 610 includes a second casing 689 located at a proximal po ⁇ ion 612 of the body 620
  • the second casing 689 includes actuation po ⁇ s 618 which are located along the second casing 689 (similar to those shown in Figure 10)
  • Located inside the second casing 689 is a sealed cavity 626 having a proximal po ⁇ ion 660 and a distal po ⁇ ion 662
  • the sealed cavity 626 is filled with a fluid 658 A flexible
  • this embodiment has the advantage that the latching mechanism provides a well defined operating threshold to allow u ⁇ ne to be drained from the device This may make the device easier to adapt for different individuals and may make the device easier to use for some individuals
  • the magnetic actuator provides for positive actuation which may be desired by some individuals who do not have sufficient muscle control to use the hydraulically actuated embodiments
  • a significant advantage provided by this embodiment is that is has a relatively low activation threshold which permits the internal and external magnets to be relatively small and convenient to use
  • Another significant advantage of this embodiment is that despite the relatively low activation threshold, it is relatively insensitive to brief, transient pressure surges which may occur due to exercise, coughing, etc
  • Still another advantage of this embodiment is that once a magnetic field of sufficient strength and duration is applied, the device opens all the wav relatively quickly due to the non-linear characteristics provided by the latching mechanism Still tu ⁇ her once the device is open it stays fully open due to the damping characteristics associated with the magnetic actuator thereby providing tor complete v oiding of the

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

Abstract

L'invention concerne un appareil et un procédé pour contrôler l'incontinence urinaire d'un individu. L'appareil comprend un dispositif tubulaire (10) qui se place dans l'urètre de l'individu. Une partie proximale (12) du dispositif tubulaire est adaptée pour communiquer avec la vessie et une partie distale (15) dudit dispositif est située à l'extrémité opposée de la partie proximale. Une lumière (21) s'étend à travers le dispositif entre une ouverture distale (19) située dans la partie distale et une ouverture proximale située dans la partie proximale. Le dispositif inclut un actionneur (22) qui réagit lorsqu'il est soumis à une force ou pression de déclenchement. L'actionneur agit sur une soupape (42) qui ouvre ou ferme l'ouverture proximale. Dans un aspect de l'invention, cette soupape est constituée d'un soufflet souple pouvant se déplacer alternivement entre une première position et une deuxième position pour ouvrir ou fermer l'ouverture proximale. Dans un autre aspect de l'invention, l'actionneur est amorti si bien qu'il ne peut agir sur la soupape que lorsqu'il y est contraint par une force ou pression de déclenchement pendant un laps de temps prédéterminé. Dans une forme de réalisation, la pression de déclenchement résulte d'une pression fluidique à l'intérieur de la vessie. Dans une forme de réalisation différente, la force de déclenchement résulte de l'application d'un champ magnétique.
PCT/US1998/026509 1997-12-18 1998-12-14 Appareil uretral muni d'une soupape grand debit et procedes d'utilisation dudit appareil WO1999030635A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU18227/99A AU1822799A (en) 1997-12-18 1998-12-14 Urethral apparatus with high flow valve and methods of use ther eof

Applications Claiming Priority (2)

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Cited By (7)

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Publication number Priority date Publication date Assignee Title
US7044980B2 (en) 2000-02-03 2006-05-16 Boston Scientific Scimed, Inc. Facilitating drainage
US7347866B2 (en) 2003-03-10 2008-03-25 Boston Scientific Scimed, Inc. Medical stent and related methods
DK201470306A1 (en) * 2014-05-28 2015-12-14 Magcath Aps A urine flow control system and a magnetic actuator device
CN110545758A (zh) * 2017-03-10 2019-12-06 西方创新公司 组织工程支架
US20200384167A1 (en) * 2014-01-07 2020-12-10 Potrero Medical, Inc. Systems, devices and methods for draining and analyzing bodily fluids
CN114007503A (zh) * 2019-06-26 2022-02-01 科洛普拉斯特公司 包括组合阀和传感器的导管
WO2022153064A1 (fr) * 2021-01-18 2022-07-21 Steaton Limited Perfectionnements apportés ou se rapportant à des systèmes de gestion de fluide

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US3812841A (en) * 1972-08-21 1974-05-28 L Isaacson Urethra magnetic valve structure
US4553533A (en) * 1983-11-08 1985-11-19 Leighton Stephen B Intra-urethral prosthetic sphincter valve
US5476434A (en) * 1992-05-27 1995-12-19 Kalb; Irvin M. Female incontinence device including electronic sensors

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Publication number Priority date Publication date Assignee Title
US3812841A (en) * 1972-08-21 1974-05-28 L Isaacson Urethra magnetic valve structure
US4553533A (en) * 1983-11-08 1985-11-19 Leighton Stephen B Intra-urethral prosthetic sphincter valve
US5476434A (en) * 1992-05-27 1995-12-19 Kalb; Irvin M. Female incontinence device including electronic sensors

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7044980B2 (en) 2000-02-03 2006-05-16 Boston Scientific Scimed, Inc. Facilitating drainage
US7347866B2 (en) 2003-03-10 2008-03-25 Boston Scientific Scimed, Inc. Medical stent and related methods
US20200384167A1 (en) * 2014-01-07 2020-12-10 Potrero Medical, Inc. Systems, devices and methods for draining and analyzing bodily fluids
DK201470306A1 (en) * 2014-05-28 2015-12-14 Magcath Aps A urine flow control system and a magnetic actuator device
CN110545758A (zh) * 2017-03-10 2019-12-06 西方创新公司 组织工程支架
CN110545758B (zh) * 2017-03-10 2022-08-09 西方创新公司 组织工程支架
CN114007503A (zh) * 2019-06-26 2022-02-01 科洛普拉斯特公司 包括组合阀和传感器的导管
WO2022153064A1 (fr) * 2021-01-18 2022-07-21 Steaton Limited Perfectionnements apportés ou se rapportant à des systèmes de gestion de fluide

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