Abstract: A device and method for treating female urinary incontinence is provided. A device in accordance with the invention includes a sheath having a distal portion, a proximal portion, and a lumen extending therebetween. A distal member is elastically hinged to the distal portion of the sheath. A flow control valve unit is disposed within a lumen of the sheath. The distal member may be urged into axial alignment with the sheath, and the device may be inserted into a female urethra. Once the device is inserted sufficiently distally into the female urethra, the distal member will return to a position which is not in axial alignment with the sheath.

Abstract: A device and method for treating female urinary incontinence is provided. A device in accordance with the invention includes a sheath having a distal portion, a proximal portion, and a lumen extending therebetween. A distal member is elastically S hinged to the distal portion of the sheath. A flow control valve unit is disposed within a lumen of the sheath. The distal member may be urged into axial alignment with the sheath, and the device may be inserted into a female urethra. Once the device is inserted sufficiently distally into the female urethra, the distal member will return to a position which is not in axial alignment with the sheath.

Abstract: A valve for a bladder control device including an elongate housing having a valve seat disposed therein. A stopper is also disposed within the housing and is moveable between a first position in which the stopper engages the valve seat and a second position wherein the stopper is moved distally of the valve seat. A tension spring can be connected to the stopper to biases the stopper toward the valve seat. A lumen is defined through the housing having a first portion disposed distally of the valve seat having a diameter approximately equal to a diameter of the stopper. A second portion of the lumen disposed distally of the first portion has a greater diameter than the first portion of the lumen. Yet a third portion of the lumen disposed distally of the second portion has a diameter less than that of the first portion.

Abstract: An improved self contained automatic bladder control device includes a valve assembly mount for releasibly receiving a valve assembly. The preferably cylindrical mount has a textured outer surface designed to interact with urethral tissue. Thus the mount can be placed nonsurgically into a urethra and in time it will be held against movement by the tissue interaction with the textured outer surface, yet the mount will still be removable without surgery. Two embodiments of valve assemblies are disclosed, each of which provides a sphincter-like operation of the bladder control apparatus. A first embodiment is designed to use Bernoulli's law to hold open the valve apparatus after a short period of muscle contraction. The second embodiment is designed to use the fact that the force generated by hydrostatic pressure is directly related to the area on which it impinges, to accomplish the desired valve holding period.

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.

Abstract: Insertion apparatus for a female bladder control device including an outer tube for insertion into the urethra of a patient, the outer tube having an inner lumen and a retention collar for limiting the depth of insertion of the outer tube. A dilator probe with a tapered end, the probe sized for slidable movement into the outer tube and the probe having stop means engagable by the first tube to limit the depth of insertion of the probe tapered end into the urethra. An applicator tube sized for slidable positioning within the outer tube and having an inner lumen for removably carrying a bladder control device for placement within the lumen. Also provided is an insertion device for moving the bladder control device into the second tube. The preferred embodiment described in this disclosure includes a spring-type retaining device mounted on one end of the placed bladder control device and an additional retainer on the other end for retaining the placed bladder control device within the urethra.

Abstract: An intraurethral bladder control apparatus including housing means having a fluid flow path therethrough, valve means mounted within the fluid valve path and normally bias closed, the valvings responsive to pressure from fluid within the bladder of the patient for opening to allow fluid flow from the bladder through the apparatus of this invention and out of the urethra. A pair of retaining devices are connected to each of the distal and proximal ends of the intraurethral bladder control apparatus. The retainer at the distal end of the apparatus preferably comprises a leaf spring having a plurality of leaves, in the preferred embodiment described herein the plurality comprising four leaves, with a safety device connected to the tip of each leaf to inhibit piercing of the bladder wall when the leaves of the distal end retainer automatically open within the bladder of the patient after placement of the intraurethral bladder control apparatus.

Abstract: A valve for a bladder control device including an elongate housing having a valve seat disposed therein. A stopper is also disposed within the housing and is moveable between a first position in which the stopper engages the valve seat and a second position wherein the stopper is moved distally of the valve seat. A tension spring can be connected to the stopper to biases the stopper toward the valve seat. A lumen is defined through the housing having a first portion disposed distally of the valve seat having a diameter approximately equal to a diameter of the stopper. A second portion of the lumen disposed distally of the first portion has a greater diameter than the first portion of the lumen. Yet a third portion of the lumen disposed distally of the second portion has a diameter less than that of the first portion.

Abstract: A device, system and method for treating female urinary incontinence is provided. A flexible sheath having distally deployed wings and proximal retainer contains a flow control valve unit within. The wings can be tucked into side access holes to reduce the profile of the sheath for insertion distally into a female urethra. Once inserted sufficiently distally into a female urethra, the wings can be deployed by inserting the flow control valve within sufficiently far to force the tucked wings out of the constraining access holes.

Abstract: A bladder control apparatus retaining device for placement within the urethra of a patient. The device includes a sheath having distal and proximal ends and an internal lumen for receiving a bladder control apparatus. Disposed at opposite ends are first and second retainers. The sheath and retainers are preferably a flexible polymer which can be coated or impregnated with an antibiotic.

Abstract: An intraurethral female bladder control apparatus and method for nonsurgically inserting the apparatus distally into a patient. A preferred apparatus has a rigid plastic inner housing with soft, flexible retainer attached distally and a flow control unit mounted within the inner housing lumen. A rigid, plastic outer housing having a softer proximal retainer and distal, upper tip, surrounds the inner housing and has the distal retainer within prior to insertion. In use, the upper tip is inserted through the urethra into the bladder and the inner housing advanced to deploy the distal retainer within the bladder floor.

Abstract: An improved intraurethral bladder control apparatus including housing means having a fluid flow path therethrough, valve means mounted within the fluid valve path and normally bias closed, the valvings responsive to pressure from fluid within the bladder of the patient for opening to allow fluid flow from the bladder through the apparatus of this invention and out of the urethra. A pair of retaining devices are connected to each of the distal and proximal ends of the intraurethral bladder control apparatus. The retainer at the distal end of the apparatus preferably comprises a leaf spring having a plurality of leaves, in the preferred embodiment described herein the plurality comprising four leaves, with a safety device connected to the tip of each leaf to inhibit piercing of the bladder wall when the leaves of the distal end retainer automatically open within the bladder of the patient after placement of the intraurethral bladder control apparatus.

Abstract: A device, system and method for treating female urinary incontinence is provided. A flexible sheath having distally deployed wings and proximal retainer contains a flow control valve unit within. The wings can be tucked into side access holes to reduce the profile of the sheath for insertion distally into a female urethra. Once inserted sufficiently distally into a female urethra, the wings can be deployed by inserting the flow control valve within sufficiently far to force the tucked wings out of the constraining access holes.

Abstract: Insertion apparatus for a female bladder control device including an outer tube for insertion into the urethra of a patient, the outer tube having an inner lumen and a retention collar for limiting the depth of insertion of the outer tube. A dilator probe with a tapered end, the probe sized for slidable movement into the outer tube and the probe having stop means engagable by the first tube to limit the depth of insertion of the probe tapered end into the urethra. An applicator tube sized for slidable positioning within the outer tube and having an inner lumen for removably carrying a bladder control device for placement within the lumen.Also provided is an insertion device for moving the bladder control device into the second tube. The preferred embodiment described in this disclosure includes a spring-type retaining device mounted on one end of the placed bladder control device and an additional retainer on the other end for retaining the placed bladder control device within the urethra.

Abstract: This apparatus is for testing valves, particularly those adapted for controlling incontinence. Microprocessor computer equipment and programs use specialized test programs and interface equipment to permit the operator to control, display and record a sequence of valve tests using screens, icons and keyboard entries. The tests are either directly computer controlled or computer directed. A manual mode permits the user to enter a specific valve test pressure versus time profile, while an automatic mode permits the user to have the profiles tests repeated automatically by the computer. Both modes provide liquid at controlled pressure to the valve under test and determines the valve's corresponding liquid output rates.

Abstract: An improved self contained automatic bladder control device includes a valve assembly mount for releasibly receiving a valve assembly. The preferably cylindrical mount has a textured outer surface designed to interact with urethral tissue. Thus the mount can be placed nonsurgically into a urethra and in time it will be held against movement by the tissue interaction with the textured outer surface, yet the mount will still be removable without surgery. Two embodiments of valve assemblies are disclosed, each of which provides a sphincter-like operation of the bladder control apparatus. A first embodiment is designed to use Bernoulli's law to hold open the valve apparatus after a short period of muscle contraction. The second embodiment is designed to use the fact that the force generated by hydrostatic pressure is directly related to the area on which it impinges, to accomplish the desired valve holding period.

Abstract: An improved intraurethral bladder control apparatus including housing means having a fluid flow path therethrough, valve means mounted within the fluid valve path and normally bias closed, the valvings responsive to pressure from fluid within the bladder of the patient for opening to allow fluid flow from the bladder through the apparatus of this invention and out of the urethra. A pair of retaining devices are connected to each of the distal and proximal ends of the intraurethral bladder control apparatus. The retainer at the distal end of the apparatus preferably comprises a leaf spring having a plurality of leaves, in the preferred embodiment described herein the plurality comprising four leaves, with a safety device connected to the tip of each leaf to inhibit piercing of the bladder wall when the leaves of the distal end retainer automatically open within the bladder of the patient after placement of the intraurethral bladder control apparatus.

Abstract: Insertion apparatus for a female bladder control device including an outer tube for insertion into the urethra of a patient, the outer tube having an inner lumen and a retention collar for limiting the depth of insertion of the outer tube. A dilator probe with a tapered end, the probe sized for slidable movement into the outer tube and the probe having stop means engagable by the first tube to limit the depth of insertion of the probe tapered end into the urethra. An applicator tube sized for slidable positioning within the outer tube and having an inner lumen for removably carrying a bladder control device for placement within the lumen. Also provided is an insertion device for moving the bladder control device into the second tube. The preferred embodiment described in this disclosure includes a spring-type retaining device mounted on one end of the placed bladder control device and an additional retainer on the other end for retaining the placed bladder control device within the urethra.

Abstract: An improved self contained automatic bladder control device includes a valve assembly mount for releasable receiving a valve assembly. The preferably cylindrical mount has a textured outer surface designed to interact with urethral tissue. Thus the mount can be placed nonsurgically into a urethra and in time it will be held against movement by the tissue interaction with the textured outer surface, yet the mount will still be removable without surgery. Two embodiments of valve assemblies are disclosed, each of which provides a sphincter-like operation of the bladder control apparatus. A first embodiment is designed to use Bernoulli's law to hold open the valve apparatus after a short period of muscle contraction. The second embodiment is designed to use the fact that the force generated by hydrostatic pressure is directly related to the area on which it impinges, to accomplish the desired valve holding period.