Bladder control device actuator

Details Bladder control device actuator Bladder control device actuator

1998-11-20

2001-04-10

Lacyk, John P. (Department: 3736)

Surgery

Body inserted urinary or colonic incontinent device or...

Reexamination Certificate

active

06213936

ABSTRACT:

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.


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