Urinary control with inflatable seal and method of using same

A urine tube extends through a balloon which is inflatable in the neck of a bladder to form a seal around the urine tube. The balloon has a shape corresponding to the shape of the bladder chamber at the urethra orifice to facilitate establishing a seal. A valve is provided on the outlet end of the urine tube and an air tube extends along the substantial length of the urine tube into the balloon. A hypodermic syringe or the like may be inserted into the inlet end of the air tube for inflating the balloon. A hydrogel collar is positioned around the urine tube against the body at the outlet end of the urethra to hold the balloon in tight engagement with the bladder neck at the urethra orifice.

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 bags is 
substantial. An inflatable conventional spherical balloon is used to keep 
the catheter in the bladder, but leakage around the catheter occurs and is 
a problem. It was not an object of this product to provide a seal around 
the catheter at the bladder orifice. 
In my co-pending application I have disclosed a urethral valve positioned 
in the orifice of the urethra. In some instances, leakage may occur around 
the outside of the valve. 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, infection and pass urine only through 
operation of the valve rather than around the outside of the catheter. 
SUMMARY OF THE INVENTION 
A urinary tube extends into the urethra and continues into the bladder. An 
inflatable balloon having a lower end portion extending into the urethra 
has a shape corresponding to the shape of the inner wall surface of the 
bladder at the orifice, extends around the bladder end of the urinary tube 
and an air line extends through the urine tube to outside the urethra 
where it is adapted to be connected to an air pump for inflating the 
balloon to provide a plug seal in the urethra around the urinary tube in 
the neck and orifice of the bladder. A valve is provided in the urinary 
tube outside of the urethra. 
An anchoring collar of hydrogel frictionally engages the exterior of the 
urinary tube and is positioned against the outer end of the urethra to 
hold the balloon lower end portion in tight sealing engagement in the 
urethra in the neck of the bladder. 
The urinary control of this invention when used by a male includes the 
additional use of a support shell around the penis to stabilize the 
urinary tube which extends through the penis. The anchoring collar of 
hydrogel is positioned against the outer end of the support shell. The 
shell is one piece but includes a plurality of sections to allow for 
fitting the support shell to penises of different sizes. A collar of 
hydrogel is also placed between the inner end of the shell sections and 
the pubic bone base of the penis. An accordion type section is included to 
give the shell flexibility in accommodating penises of different lengths 
and to permit them to be disposed at varying angles to the body. 
A hypodermic syringe or the like may function as an air pump when its 
needle is inserted into the air tube to inflate the balloon.

DESCRIPTION OF THE PREFERRED EMBODIMENT 
The urinary control of this invention is referred to generally by the 
reference numeral 10 as seen in FIG. 1 and includes a urine tube 12 in 
which a valve 14 is connected. The tube 12 has an outer outlet end 15 and 
an inner inlet end 16 with sidewall openings 18. 
An air tube 20 extends into the valve body 14 and along the length of the 
tube 12 towards the inlet end 16. The air tube 20 has an inlet end 22 and 
an outlet end 24 positioned in a balloon 26 formed in part by the 
sidewalls of the urine tube 14. Balloon chamber 28 is provided. The air 
tube outlet end includes an opening 30 in chamber 28. 
The valve body 14 includes a pair of oppositely disposed blade elements 32 
normally closed. Pressure on the opposite sidewalls of the valve body 14 
will cause the valve elements 32 to spread as seen in FIG. 5 and allow 
urine to flow toward the outlet end 14. 
An anchoring collar means 36 of hydrogel is provided around the urine tube 
12 outwardly of the balloon 26 and frictionally engages the outer surface 
of the urine tube 12 to hold the walls of the balloon 26 in tight sealing 
contact with the bladder orifice and neck 38 as seen in FIG. 2. The 
balloon 26 is shaped to correspond to the shape of the inner side walls of 
the bladder at the orifice to provide a seal around the catheter thereby 
preventing leakage. This shape is generally pear shape as seen in FIGS. 2 
and 6, the balloon 26 when inflated includes an enlarged upper portion 
which merges into a downwardly extending reduced in size lower portion. In 
the female, the collar 36 presses against the body around the opening to 
the urethra. A sleeve 42 also extends around the urine tube 12 and may be 
adjusted tightly against the collar 36 to assist in holding the collar 
tight against the person's body at the outlet end of the urethra. Rounded 
serrations 44 are provided along the outside of the urine tube 12 and 
register with serrations on the inside face of the collar 36 and serve to 
hold the collar 36 in place in turn holding the balloon seal 26 in place 
thereby preventing leakage around the tube 12. 
A hypodermic syringe 48 functions as an air pump and has a needle 50 which 
is inserted into the inlet end 22 of the air tube 20. The inlet end 22 has 
a passageway 52 normally closed except when opened by the needle 50 
thereby allowing air to be introduced into the tube to fill the balloon 26 
but when the needle 50 is removed the passageway is sealed preventing air 
from escaping and deflating the balloon. 
When the urinary control of this invention is used on a male, a one piece 
support shell 60 is provided around the penis 62 and includes an outer 
section 64 having an outer end 64A being rounded to the curvature of the 
head of the penis. An accordion pleats section 64B interconnects the outer 
section 64 with a base section 64C. The base section 64C presses against a 
hydrogel collar 66 which presses against the base (pubic bone) 68 of the 
penis. A second hydrogel collar 70 is positioned against the outer end of 
the rounded section 64A to hold the urine tube 12 in place such that the 
lower portion of the balloon 26 when inflated is pressed against the 
bladder neck 38 and into the urethra. Among the properties of hydrogel is 
that it is soft and pliable but yet firm. 
In use it is seen that the urine tube 12 will be inserted into the urethra 
of the male or female far enough that the of the balloon 26 will function 
as a retention means and the lower portion will be seated in the urethra 
at the neck 38 of the bladder and functions as a plug to prevent urine 
flow on the outside of the urine tube 12. Air is introduced into the air 
tube 20 through the use of a hypodermic syringe. A hydrogel collar is then 
positioned against the body at the outer end of the urethra to hold the 
balloon 26 in position to maintain the seal in the urethra the bladder 
neck 38. The balloon is inflated from the solid line position in FIG. 2 to 
the dash line inflated condition. When fully installed, no urine can leak 
around the urine tube 12 due to the seal the balloon 26 provides with the 
bladder neck 38. Urine can enter the openings 18 in the inlet end 16 of 
the urine tube 12 and pass into the valve 14 and upon actuation of the 
valve blades 32 by applying pressure to opposite sides of the valve 14, 
the valve will be open for drainage of the bladder through the outlet end 
15. 
The valve 14 and urine tube 12 are formed from elastomer silicone material 
of a 50 or 55 durometer from Dow Corning, Midland, Mich. Tubing of this 
material is flexible and longitudinally collapsible such that longitudinal 
compressive pressure applied to it will not unseat the balloon lower 
portion in the urethra at the neck and orifice of the bladder and cause 
leakage around the tubing. The balloon 26 may have a capacity of 
approximately 40 cc's.