Urinary Control Valve and Method of Using Same

Incontinence is a problem for many people including older adults. Present day approaches to dealing with incontinence such as the Foley catheter often times causes urinary tract infection. A bag for urine is required and smell becomes a problem. The chances of infection are increased each time the bag is changed. The cost for the Foley catheters and pads is substantial.

What is needed is a simple inexpensive device for controlling urine flow in the urethra which is compatible to the body and will not cause discomfort or infection.

A disposable urethral valve of soft silicone material is placed in the orifice of the urethra. Oppositely disposed blade valve elements extend from the side walls of a tube laterally and longitudinally inwardly into engagement with each other in a normally closed position. The tube side walls are enlarged outwardly from the valve blade elements and their connection to the side walls thereby providing cavities between the blade elements and the side walls for urine to accumulate and build up pressure on the laid elements to keep them engaged and the valve closed. Pressure on the outside of the enlarged tube portion will spread the free ends of the blade elements and allow flow of urine from the bladder through the valve.

In the male, the entire valve is positioned in the orifice end of the urethra while in the female the enlarged bulb portion of the tube is disposed outwardly of the orifice in the labia majora such that access by the user's hand is possible for operation of the valve.

Serrations are provided on the outer tube side wall to increase the resistance to flow around the tube between the tube and the inside surface of the urethra.

In the male, the bulb or enlarged portion of the tube is positioned in the fossa navicularis and a portion of the tube extends outwardly to the end of the urethra.

Indica is provided on the opposite sides of the tube for orientation purposes such that it is known when it is inserted into the urethra where pressure needs to be applied to operate the valve. Ordinarily it would be positioned so pressure is applied on the top and bottom or on opposite sides. In the male, the pressure is applied to the opposite sides of the penis and will be transmitted to the opposite sides of the bulb in the tube for opening the valve. The pressure points on the bulb are in a plane extending through the interface plane of the blade elements.

FIG. 1 is a perspective view of the urinary control valve.

FIG. 2 is a side elevational view thereof.

FIG. 3 is a cross-sectional view taken along line 3--3 in FIG. 2.

FIG. 4 is an enlarged cross-sectional view taken along line 4--4 in FIG. 3.

FIG. 5 is a cross-sectional view taken along line 5--5 in FIG. 4 showing the valve in its normally closed position.

FIG. 6 is a cross-sectional view similar to FIG. 5, but showing the valve in its open position.

FIG. 7 is a fragmentary cross-sectional view of the valve in the orifice of the urethra in a male penis, and

FIG. 8 is a fragmentary cross-sectional view of the valve in the orifice of the urethra in a female.

The urethra urinary control valve in this invention is referred to generally in FIG. 1 by the reference numeral 10 and includes an elongated tube 12 having a forward end, inlet tube portion 14 and a rear or outer end outlet tube portion 16 interconnected by an enlarged valved body bulb portion 18

In the enlarged bulb portion 18 are oppositely disposed wedge shaped blade valve elements 20 which are integral with the tube side wall and extend laterally inwardly and longitudinally forwardly as seen in FIG. 4. The blade elements 20 meet along their forward free ends along a straight line 22 to seal the tube against liquid flow from the right to the left as seen in FIG. 4 and indicated by the arrow 24. The blade elements 20 are substantially flat along at least their free ends to maximize the surface area 26 facing the inside tube wall surface 28 forming a cavity 30 between the blade elements 20 and the enlarged wall portion 28.

It is seen that urine in the forward tube portion 12 will fill the cavities 30 and apply pressure to the surface areas 26 of the blade elements 20 to maintain them in a closed position. Thus as they urine pressure increases, the pressure to keep the blade elements closed increases making for a foolproof valve.

The opening of the valve is accomplished by applying pressure on opposite sides of the bulb enlarged tube portion at pressure points 34 in a plane extending through the interface plane of the blade elements as seen in FIG. 5. This pressure will spread the free ends of the blade elements 20 apart to form a passageway 40 as seen in FIG. 6 whereby flow through the valve is possible.

Annular serrations 42 are provided on the outside of the tube portions 14 and 16 and thus enhance the resistance to flow of urine around the outside of the tube between the tube and the inside surface of the wall of the urethra 46 as seen in FIG. 7 in the male and the urethra 48 in FIG. 8 in the female.

When used by the male as seen in FIG. 7, it is placed in the outlet orifice of the urethra such that the valved body bulb portion 18 is positioned in the fossa navicularis with the outer portion 16 extending outwardly to the distal end of the urethra.

When used by the female, the inner tube portion 14 is inserted into the orifice 50 of the urethra 48 up to the bulb portion 18 which along with the outer tube portion 16 is positioned in the labia majora where the valve is protected against unintended operation and is concealed against inadvertent contact with clothing and the like.

Thus in operation, it is seen that orientation indicia 60 is provided on the top and bottom surfaces of the tube portion 14 or in any other convenient location to indicate the relative position of the pressure points 34 such that when inserted the user will know where to apply pressure. Ordinarily the valve would be orientated so that pressure would be applied on the top and the bottom or on opposite sides. In the male, pressure is applied to the outside of the penis directly opposite the pressure points 34 as indicated by the arrows 70 in FIG. 7. This will cause the free ends of the blades 20 to spread apart as seen in FIG. 6 allowing urine flow through the passageway 40 formed by the spaced apart blades 20. In the female, as seen in FIG. 8, access is provided to the bulb 18 in the labia majora such that pressure may be applied to the pressure points 34 to open the valve. When pressure is removed the valve will normally close due to the memory of the elastomer silicone material. Elastomer silicone of a 50 or 55 durometer from Dow Corning, Midland, Mich., is recommended as it is compatible with the human body. While the valve may have varying dimensions to suit particular needs, it is suggested that it be three centimeters long with a 2 millimeter wall thickness for use in the typical urethra having a 6 millimeter internal diameter. A gel, such as Zylocain may be used for ease of inserting into the urethra.