Abstract:
A system for initiating urine flow in intraurethral bladder control devices having a housing, a flow lumen, a valve biased to close, a distal end disposed near the urethral meatus, and a proximal end disposed near the bladder. The system includes an actuator device to open the valve. One intraurethral bladder control device has a higher velocity flow region near the valve distal end, such that the Bernoulli effect generates a negative pressure on the valve, keeping the valve in an open position once urine flow commences. One valve includes a spring biased stopper in the urine flow lumen. One actuator device is a suction device adapted to mate to the intraurethral device distal end and capable of pulling the stopper into the open position. Suction devices include plungers, syringes, and squeezable bulbs. Another actuator device includes a magnet capable of moving a magnetically responsive stopper. Yet another actuator device includes an elongate member disposed within the device housing and operably coupled to the stopper. Grasping and manipulating a free distal end of the elongate member causes the stopper to open and initiate urine flow.

Description:
FIELD OF THE INVENTION 
     The present invention relates generally to medical devices and more particularly to intraurethral bladder control devices. Specifically, the invention relates to devices adapted to initiate urine flow in intraurethral devices and, more specifically, capable of initiating urine flow in users unable to generate sufficient bladder pressure due to atonic bladder disorder. 
     BACKGROUND OF THE INVENTION 
     The use of sphincter and bladder control devices is wide spread in the field of the present invention. See, for example, commonly assigned U.S. Pat. Nos. 5,512,032; 5,701,916; 5,701,916; and 5,722,932, herein incorporated by reference. Many existing intraurethral devices seek to duplicate the function of normal urinary sphincter control. This usually involves opening a valve in response to a user initiated stimulus, for example, an initial moment of high bladder pressure generated by the user of the device. In some devices, once begun, flow can be maintained without requiring continuing high bladder pressure. 
     There exists a class of potential users of these devices that cannot generate even a moment of sufficiently high bladder pressure to initiate flow through the aforementioned devices. Some users cannot generate pressure due to atonic bladder disorder. These individuals could maintain urination through some of the intraurethral devices, if the device could be initially opened to flow without requiring high bladder pressure. What has not been provided are devices and methods for initiating urine flow in devices in cases where the users can maintain flow through the devices, but cannot initiate urine flow. 
     SUMMARY OF THE PRESENT INVENTION 
     Devices and methods according to the present invention give a large number of people, previously unable to use intraurethral devices, the ability to deal with urinary incontinence using such devices. In particular, the present invention allows users of a class of intraurethral devices to initiate urine flow through the devices without having to generate high bladder pressure. One class of intraurethral devices within the scope of the present invention includes a substantially cylindrical housing having a wall, a proximal end having a proximal retainer, a distal end having a distal retainer, a valve therein, and a lumen therethrough. The proximal retainer is adapted to fit against the bladder wall and the distal retainer is adapted to fit against the urethral meatus. 
     The valve in a preferred device includes a stopper slidably disposed within the housing lumen and biased in a proximal direction so as to normally preclude urine flow. The stopper can typically rest proximally and tightly against a valve seat when closed and distally on standoffs against a retaining ring when open, leaving channels around the stopper for fluid flow. Once initiated, flow through the channels is of sufficiently high velocity so as to create a negative pressure on the stopper through the Bernoulli effect. In users not having significant bladder pressure problems, the user can initiate flow by forcing the stopper into a distal, open position with an initial moment of high bladder pressure. In users having significant problems, other methods and actuating devices according to the present invention can be used. 
     One system according to the present invention includes an intraurethral device as described above and a suction actuating device. One suction device includes a plunger having an end adapted to fit snuggly within the intraurethral device lumen, such that inserting the plunger within the lumen and rapidly withdrawing it generates a vacuum, causing the stopper to be pulled distally into the open position. Another suction device includes a syringe having an orifice adapted to mate to the intraurethral device lumen, such that forcing the syringe orifice against the intraurethral distal end and retracting the syringe plunger creates a negative pressure, thereby moving the stopper into the open position. Yet another suction device includes a squeezable bulb having an orifice adapted to mate to the intraurethral device distal end. The bulb can be squeezed or collapsed, the orifice can be forced against the intraurethral device distal end, and the bulb released, thereby generating suction and pulling the stopper into an open position. 
     One system according to the present invention includes an intraurethral device similar to that described above, but having a magnetically responsive stopper. A magnet can be included in the actuating device, such that the magnet can be used to force the stopper into the open position. In one system, the magnet is used to pull the stopper distally to open the valve. 
     In another system according to the present invention, an elongate member is disposed within the intraurethral device housing and coupled to the stopper. In one intraurethral device, the elongate member includes a flexible string or tape region, such that pulling on the elongate member causes tension in the elongate member and operates to force the stopper into the open position. In another intraurethral device, the elongate member includes a rod member capable of transmitting a compression force. 
     In use, the actuating device can be brought within an effective range of the intraurethral device and operated to force the stopper into the open position and allow urine flow to commence. Once urine is flowing within the device, high velocity flow through a channel of the valve generates a negative pressure through the Bernoulli effect. The negative pressure acts on the stopper to keep the stopper in the open position. Once urine flow drops below a certain threshold or stops altogether, the stopper, being biased to remain in the closed position, closes. 
    
    
     BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1 is a perspective view of a bladder control device for insertion in a female urethra; 
     FIG. 2 is cutaway, fragmentary side view of the bladder control device of FIG. 1 disposed in a female urethra, between the bladder and urethral meatus; 
     FIG. 3 is a cutaway, perspective view of the bladder control device of FIG. 1 having a urine flow lumen and a valve stopper in a proximal, closed position; 
     FIG. 4 is a cutaway, perspective view of the bladder control device of FIG. 3 having the valve stopper in a distal, open position; 
     FIG. 5 is a cutaway, side view of the device of FIG. 1 in closed position, having a plunger actuator in the process of being positioned in the flow lumen; 
     FIG. 6 is a cutaway, side view of the device of FIG. 6 in open position, after the plunger has been withdrawn and urine flow initiated; 
     FIG. 7A is a cutaway, side view of a bladder control device in closed position having a housing wall including a lumen therein, and an elongate actuating member disposed within the wall lumen; 
     FIG. 7B is a cutaway, side view of the bladder control device of FIG. 7A, having the elongate member distally moved, causing the valve stopper to open; 
     FIG. 8A is a cutaway, side view of a bladder control device in a closed position having a housing wall including a lumen therein, and an elongate member disposed within the wall lumen; 
     FIG. 8B is a cutaway, side view of the bladder control device of FIG. 8A, having the elongate member proximally pushed, causing the valve stopper to open; 
     FIG. 9 is a cutaway, side view of a bladder control device having a magnetically responsive valve stopper and an actuator magnet capable of forcing the stopper into an open position; 
     FIG. 10 is a cutaway, side view of a bladder control device inserted into a female urethra, having a suction device orifice mated to the flow control device distal end; 
     FIG. 11 is a fragmentary, perspective view of the distal end of a bladder control device and a suction device tube adapted to be inserted within the bladder control device lumen; and 
     FIG. 12 is a fragmentary, perspective view of the distal end of a bladder control device and a suction device tube adapted to abut the flow control device distal end. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1 illustrates a bladder control device  20  having a proximal end  22  and a distal end  24 , extending from a proximal retainer  26  through a housing  34  to a distal retainer  28 . Proximal retainer  26  can include a plurality of leafs springs  30 , preferably terminating in hemispheric safety pads  32 . Housing  34  includes a urine lumen  36  extending therethrough, and a valve within. FIG. 2 illustrates bladder control device  20  disposed within a female bladder  38  and a urethra  42 , extending between a bladder wall  40  and urethral meatus  43 . Proximal retainer  26  prevents bladder control device  20  from migrating out of the body, while distal retainer  28  prevents migration into the body. 
     Referring now to FIG. 3, bladder control device  20  is illustrated in greater detail, showing a flow control valve  44  in a closed position. Valve  44  including a valve seat  46 , a stopper  48 , and a spring  50 . In the embodiment shown, spring  50  biases stopper  48  against valve seat  46 , thereby closing valve  44  and precluding urine flow through lumen  36 . A spring mounting ring  52  retains spring  50  distally and a blind lumen  56  within stopper  48  bounds spring  50  proximally. A stopper retaining ring  54  limits the stopper distal travel and provides flow channels for urine between stopper  48  and stopper retaining ring  54 . Valve seat  46  has a narrowing shoulder portion  58  and a narrower, constricted portion  60 , leading to a lumen throat region  62 . Stopper  48  has a stopper shoulder region  64  and a stopper proximal nose region  66 . In the embodiment shown, in the closed position, stopper nose  66  fits snuggly within valve seat constricted region  60  and stopper shoulder  64  presses against valve seat shoulder  60 . 
     Referring now to FIG. 4, bladder control device  20  is shown having valve  44  in open position, with stopper  48  near stopper retaining ring  54 . Urine in flows through a channel  68  between stopper  48  and retaining ring  54 . Standoffs  70  may be seen keeping stopper  48  nominally centered, away from the walls of housing  34 , and away from retaining ring  54  allowing flow around the stopper, between the standoffs. As the cross sectional area available for flow is less than the area of throat  62 , the fluid velocity is greater in channels  68  than in throat  62 . The higher speed flow creates a negative pressure on stopper  48  through operation of the Bernoulli effect, acting to pull stopper  48  proximally, keeping valve  44  open. While open, valve stopper  48  has both nose  66  and shoulder  64  exposed to hydrostatic pressure. The greater amount of surface area exposed while open also serves to keep valve stopper  48  in open position. 
     In device users able to generate sufficient bladder pressure, an initial amount of bladder pressure is applied, bringing fluid pressure to bear on stopper  48 , forcing stopper  48  proximally against spring  52  and moving the stopper axially downward to rest on retaining ring  54 . The higher flow rate around stopper  48  between standoffs  70  and in channels  68  creates sufficient negative pressure on stopper  48  to hold valve  44  in the open position, even without any user applied bladder pressure. When the flow stops or decreases below a threshold, the negative pressure is no longer sufficient to oppose spring  50  and spring  50  forces stopper  48  to the closed position. Thus, while high bladder pressure is required to initially open valve  44 , normal flow is sufficient to hold valve  44  open. 
     In device users having an atonic bladder disorder, it may not be possible to generate bladder pressure sufficient to open valve  44 . Referring now to FIG. 5, bladder control device  20  is again illustrated. Device  20  includes a distal lumen region  74  having housing wall  76  and an inside diameter indicated by “D”. An actuator device in the form of a plunger  100  is inserted within distal lumen region  74 , fitting snuggly against wall  76 . In the embodiment shown, plunger  100  includes a head  102  having resilient outer edges  104 . Attached to head  102  is an elongate central member  106  secured to plunger head  102 . Elongate member  106  has a proximal portion  108 . In one embodiment, elongate member  106  is a rigid, capable of pushing plunger head into lumen  74 . In another embodiment, elongate member  106  is a flexible string or tape, secured to proximal portion  108  which is preferably rigid. In this tape embodiment, a finger or other member can be used to insert plunger head  102  within lumen region  74 . 
     After insertion, when urine voiding is desired, elongate member  106  can be grasped and pulled in a distal direction, away from bladder control device  20 . This action is illustrated in FIG.  6 . This action causes plunger head  102  to slide out of lumen region  74 , creating a suction or negative pressure. This suction causes stopper  48  to move axially and distally toward retaining ring  54 , allowing urine to flow past stopper  48 , thereby initiating the Bernoulli effect and the resultant negative pressure. The flow caused negative pressure should then be sufficient to maintain stopper  48  in open position until urine flow decreases below a threshold or stops. After urine voiding is complete, the previous plunger or a fresh plunger can be inserted. 
     Referring now to FIG. 7A, another embodiment is illustrated in a bladder control device  220 . Device  220  includes a housing  234 , a housing wall  235 , and a lumen  236  disposed within housing wall  235 . An actuator device in the form of an elongate member  238  is slidably disposed within lumen  236 . Elongate member  238  includes a distal portion  241  and a proximal portion  240 . Proximal portion  240  includes an arcuate, U-shaped portion  242  which includes a tip  243  which can be brought to bear on stopper  48 . In one embodiment, elongate member  238  is formed of a rigid material capable of bearing tension and compression forces without significant buckling. In another embodiment, U-shaped portion  242  can bear compression force while distal portion  241  is a string or tape which can transmit only tension force. 
     Referring now to FIG. 7B, use of bladder control device  220  and actuator elongate member  238  is illustrated. When urine voiding is desired, the externally accessible portion of member distal portion  241  can be grasped by the wearer and pulled away from device  220 . In one embodiment, lumen  236  includes a proximal, wide, slotted region  237 , allowing arcuate portion  242  some travel in a proximal-distal direction. Arcuate portion  242  is thereby pulled distally, brining tip  243  to bear on stopper  48 , thereby forcing stopper  48  away from valve seat  46  and toward retaining ring  54 , thereby opening the valve and initiating urine flow. Once urine flow commences, the forces previously discussed serve to keep stopper  48  in the open position until flow sufficiently decreases or stops. The coupling force between the grasped member and stopper  48  thus includes both tension and compression in the embodiment illustrated in FIG.  7 B. 
     Referring now to FIG. 8A, another embodiment is illustrated in a bladder control device  520 . Device  520  includes housing  234 , housing wall  235 , and lumen  236  disposed within housing wall  235 . An actuator device in the form of a pushable elongate member  538  is slidably disposed within lumen  236 . Elongate member  538  includes a distal portion  541  and a proximal portion  540 . Proximal portion  540  includes an arcuate, U-shaped portion  542  which includes a tip  543  which can be brought to bear on stopper  48 . In one embodiment, elongate member  538  is formed of a rigid material capable of bearing compressive forces without significant buckling. In particular, the portion of elongate member  538  near tip  543  should be capable of bearing compressive forces without buckling. 
     Referring now to FIG. 8B, use of bladder control device  520  and elongate actuator member  538  is illustrated. When urine voiding is desired, the externally accessible portion of member distal portion  541  can be grasped by the user and pushed into device  520 . Arcuate portion  542  is thereby subject to compression, forcing member  538  to slide through lumen  236  and forcing tip  543  to bear on topper  48 , thereby forcing stopper  48  away from valve seat  46 . In this embodiment, over most of its length, elongate member  538  is supported against buckling by lumen  236 . 
     Referring now to FIG. 9, another bladder control device  320  is illustrated. Device  320  uses a magnet  322  as an actuator and magnetic force as a coupling force. In device  320 , a magnetically responsive stopper  348  is included in the device. As used herein, “magnetically responsive” means capable of being attracted or repelled by a magnetic force. In one embodiment, stopper  348  if formed of a magnetically responsive material. In one embodiment, a magnetically responsive material is enclosed in a protective, polymeric layer. In another embodiment, a magnetically responsive material is embedded in a polymeric material. In yet another embodiment, a magnetic member is operably secured to the stopper. One class of magnetic materials suitable for use in a magnetic embodiment includes ferromagnetic materials. 
     In use, magnetic actuator  322  can be brought within its effective range, sufficiently close to exert an attractive force on stopper  348 . Magnet  322  can then be moved alongside or “swiped” over device  320 , substantially parallel to the longitudinal axis. The magnetic force acting on the stopper pulls the stopper away from valve seat  46  and toward retaining ring  54 . In another method, magnet  322  is disposed near distal end  24 , with the magnet having sufficient effective range to pull stopper  348  into an open position. After flow has been initiated, magnet  322  can be removed, and urine flow continues. 
     Referring now to FIG. 10, another bladder control device  420  is illustrated. Device  420  includes a distal end  428  in fluid communication with a urine flow lumen. An actuator in the form of a suction device  421  is illustrated, having a squeezable bulb  430  in communication with an inlet tube  440  and, preferably, an outlet tube  444 . The coupling force between bulb  430  and the bladder device is a negative pressure or suction. Inlet tube  440  has an orifice  442  adapted to mate to bladder device distal end  428 . Suction bulb  430  has an inlet end  432  and an outlet end  434 . Inlet end  432  has a one way valve  436 , and outlet end  434  also has a one way valve  438 . Inlet one way valve  436  allows fluid into the bulb and outlet valve  438  allows fluid out of the bulb into outlet tube  444 . 
     In use, inlet tube  440  can be mated to device distal end  428 . Bulb  430  can be squeezed, partially collapsing the bulb and forcing air out through outlet valve  438  while inlet valve  436  remains shut. When released, bulb  430  expands, outlet valve  438  is pulled shut by the vacuum, directing the vacuum through now open inlet valve  436 . Once urine flow is initiated, the urine can flow through bulb  430  and outlet valve  438 , through outlet tube  444 . In one embodiment, outlet valve  438  closes in the presence of vacuum in bulb  430 , but remains open in the absence of suction pressure. Outlet tube  444  can lead to a reservoir for holding urine. Suction device  421  is suitable for use in institutions in general, and for bed-ridden patients in particular. 
     Referring now to FIG. 11, bladder control device distal end  428  is further illustrated, having an inlet  429  adapted to receive a tip  431  of tube  442  within. In one embodiment, tip  431  has a plurality of ribs to secure tip  431  within device end  428 . Referring now to FIG. 12, another tip  443  is illustrated, having a pair of wings  445  for wrapping around a lip  447  on device distal end  428 . Wings  445  are preferably formed of an elastomeric, resilient material adapted to receive lip  447 . Tip  443  can be fit over lip  447  for the duration of the urine voiding and subsequently removed. 
     Numerous characteristics and advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size and ordering of steps without exceeding the scope of the invention. The invention&#39;s scope is, of course, defined in the language in which the appended claims are expressed.