Female urinary drainage device

A noninvasive urinary drainage device is described which includes a urethral tube with a slanted upper end shaped to seal against the urethral area of a female user. This tube serves to support two stacked discs, each of which is flat, plate-like, and flexible. These two discs are configured to mechanically engage the labia minora and majora of the user. The lower end of the urethral tube is secured to a drainage tube adapted to conduct urine away from the user into a suitable receptacle. The urethral tube is held in place on the user by means of a pad which is provided with an indentation shaped to receive the larger of the two discs. This pad is formed of an absorbent material and can, for example, be held in place by means of a suitable belt. The ends of the pad are formed by an elastic net which supplies a gentle, even pressure holding the urinary drainage device in place.

BACKGROUND OF THE INVENTION 
The present invention relates to a non-invasive urinary drainage device for 
a female user suffering from incontinence or stress incontinence. 
A wide variety of urinary drainage devices is known to the prior art. The 
devices disclosed in Breece, U.S. Pat. No. 3,194,238, Cooney, U.S. Pat. 
No. 4,198,979, Anderson, U.S. Pat. No. 4,194,508, Michaud, U.S. Pat. No. 
4,270,539, and Moss, U.S. Pat. No. 3,601,125 disclose a number of such 
prior art devices. The Breece, Michaud and Moss devices are non-invasive, 
and are in each case held in place by means of belts. 
In spite of the large amount of activity in this area, a need presently 
exists for an improved urinary collection device for use by female users 
which provides effective sealing in a simple, reliable and economical 
manner, and which is comfortable and nonirritating in use. 
SUMMARY OF THE INVENTION 
The present invention is directed to an improved urinary device which is 
particularly simple in construction, which operates in an effective and 
comfortable manner, and which minimizes problems related to contamination 
and infection. 
According to this invention, a noninvasive urinary drainage device for a 
female user is provided which comprises a conforming elastomeric urethral 
tube having a lower end and a slanted upper end shaped to conform to and 
seal around the urethral region of the user. A first flat disc is formed 
of a conforming elastomeric material and defines a first central opening. 
A second oval-shaped flat disc is provided, also formed of a conforming 
elastomeric material, and the second disc defines a second central opening 
positioned in an offset manner in the second disc. The first and second 
discs are shaped to mechanically engage the labia minora and majora, 
respectively, of the user. The tube passes through the first and second 
openings and is secured to the first and second discs adjacent the 
openings. The upper end of the tube defines a posterior end and an 
anterior end, and the posterior end extends farther from the first disc 
than does the anterior end. The second opening is situated in the second 
disc such that the posterior end of the tube is situated nearer the 
perimeter of the second disc than is the anterior end of the tube. The 
tube and discs cooperate to hold the slanted upper end of the tube in a 
sealing relationship against the urethral region of the user in a 
noninvasive manner. A replaceable pad which is formed of an absorbent 
disposable material is used to secure the drainage device in place. 
Preferably, the pad is indented to receive the device, and the pad is 
formed of a stretchable material which provides a gentle, even pressure 
holding the device in place. 
The preferred embodiment of the present invention has been found to provide 
a particularly effective, noninvasive urinary drainage device which is 
comfortable in use and simple in manufacture. This simplicity of 
construction results in a device which is relatively inexpensive to 
produce. 
The invention itself, together with further objects and attendant 
advantages, will best be understood by reference to the following detailed 
description, taken in conjunction with the accompanying drawings.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENT 
Turning now to the drawings, FIGS. 1-3 show three views of a presently 
preferred embodiment of the urinary drainage device of this invention. 
FIGS. 4 and 5 show the device as used with a pad and belt to hold the 
device in place. 
In the figures, the reference numeral 10 is used to refer generally to the 
illustrated embodiment of this invention. This embodiment 10 is made up 
essentially of four parts; a urethral catheter or tube 20, a circular disc 
30, an oval disc 40, and a drainage tube 50. The device is held in place 
as shown in FIGS. 4 and 5 by a pad 80 and a belt 88. 
As best shown in FIGS. 1-3, the urethral tube 20 defines an oval-shaped 
slanted upper end 22 and a lower end 28. The upper end 22 is slanted as 
shown in FIG. 1 and it defines a posterior end 24 and an anterior end 26. 
The urethral tube 20 is longer at the posterior end 24 than it is at the 
anterior end 26. The tube 20 forms the central structural connecting 
member of the entire embodiment 10. 
A circular, flexible disc 30 is provided which defines a central opening 32 
sized to fit over an intermediate portion of the urethral tube 20. The 
central disc 30 is secured to the tube 20 by means of a suitable adhesive 
at the point where the tube 20 passes through the central opening 32. The 
disc 30 need not be precisely circular; its shape is selected to 
mechanically engage the labia minora of the user. 
An oval disc 40 is also provided which defines a central opening 42 sized 
to fit over the urethral tube 20. As before, the oval disc 40 is secured 
firmly to the urethral tube 20 by means of a suitable adhesive at the 
point where the tube 20 passes through the opening 42. As used herein, the 
term "oval" is intended in its broad sense to encompass a wide range of 
elliptical and other elongated shapes. The disc 40 need not be shaped 
precisely as shown in the drawings; its shape is selected to mechanically 
engage the labia majora of the user. 
As shown in FIGS. 1-3, the urethral tube 20 is not precisely centered in 
the oval disc 40. Rather, the tube 20 is offset in the oval disc 40, and 
is situated on a major axis 44 of the disc 40. This major axis 44 
corresponds to a maximum diameter of the oval disc 40 and extends between 
a posterior end 41 and an anterior end 43 of the oval disc 40. The disc 40 
is provided with an array of perforating holes 46,48 which extend 
completely through the oval disc 40 as shown in FIG. 1. It should be 
understood that the circular and oval discs 30,40 are both secured to the 
urethral tube 20, but that otherwise the two discs 30,40 are independent 
of one another and free to flex, fold and bend with respect to one 
another. 
A drainage tube 50 is secured to the lower end 28 of the urethral tube 20, 
as for example by means of a suitable adhesive. This drainage tube 50 is 
adapted for connection to an extension tube 60, as for example by means of 
a standard connector fitting as shown in FIG. 1. In use, the extension 
tube is typically connected to a sealed container such as a collapsed bag. 
In alternate embodiments of this invention, the drainage tube 50 can be 
provided with an extended length, and the extension tube 60 can be 
entirely eliminated. 
As shown in FIGS. 1-3, the circular and oval discs 30,40 are pliable, 
planar, and plate-like, and they are provided with parallel upper and 
lower surfaces which are co-extensive with the respective discs, 30,40. No 
ridges or rims of any type are provided, in order not to interfere with 
the conformability and flexibility of the discs 30,40. 
Merely by way of illustration and not by way of limitation, the following 
details regarding materials and dimensions are provided to clarify the 
structure of the illustrated embodiment. In this embodiment, the urethral 
tube 20 has a length of 2 centimeters and a maximum width across the upper 
end 22 of 1.5 centimeters. The posterior end 24 extends away from the 
circular disc 30 by 1.5 centimeters, and the anterior end 26 extends away 
from the circular disc 30 by 1 centimeter. In this embodiment, the 
urethral tube 20 is made of a flexible, conformable, elastomeric silicone 
material of approximately 30 durometer. 
In the illustrated embodiment, the circular disc 30 has a diameter of 2.5 
centimeters and a central opening sized to fit over the tube 20. The disc 
30 is approximately 3 millimeters in thickness and is formed of a 
semiflexible elastomeric silicone material of approximately 45 durometer. 
The oval disc 40 in the illustrated embodiment has a greatest length of 7.5 
centimeters, a greatest width of 4.7 centimeters, a thickness of 3 
millimeters, and is formed of a flexible silicone material of 
approximately 30 durometer. In this embodiment the perforating holes 46,48 
are 1/8th inch in diameter. 
In the illustrated embodiment, the drainage tube 50 does not contact the 
user, and therefore can be made of a more rigid material, such as a 
silicone material of 160 durometer. The entire embodiment 10 should 
preferably be formed of sterilizable materials which can be disinfected in 
a simple and reliable manner. 
As shown in FIGS. 4 and 5, the embodiment 10 is held in place against the 
body of the user by means of an indented pad 80. As shown in FIG. 5, this 
pad 80 is formed of a central absorbent cotton mass 82 which is surrounded 
by an elastic tubular mesh or net 84. This net 84 defines two ends 86 
which are adapted for connection to a belt 88. The belt 88 can, for 
example, be a standard sanitary belt known to the art. The pad 80 defines 
an indentation 90 sized to receive the oval disc 40, as well as a passage 
92 sized to receive the drainage tube 50. As shown in FIG. 5, in use the 
embodiment 10 fits within the indentation 90 formed in the pad 80 in order 
to position the embodiment 10 properly. The pad 80, and in particular the 
tubular net 84, serve to provide a gentle, even pressure to hold the 
embodiment 10 properly in place. If desired, the pad 80 can be impregnated 
with an antibacterial agent to retard infection. Preferably, both the 
embodiment 10 and the pad 80 are formed to avoid the rectal and vaginal 
areas of the user (when the anterior end 43 of the oval disc 40 is 
positioned anteriorly on the user) in order to avoid as much as possible 
contact with rectal and vaginal discharges. 
In use, the illustrated embodiment has been found to provide a particularly 
effective urinary drainage device. The urethral tube 20 is shaped to seal 
against the urethral region of the user, around the urethral opening, in a 
reliable yet comfortable manner. The circular and oval discs 30,40 are 
shaped so as to mechanically engage the labia minora and majora, 
respectively, so as to position the urethral tube 20 properly while 
avoiding disadvantages related to the use of invasive catheters. The 
disclosed embodiment is comfortable and relatively nonirritating in use, 
and it minimizes infection of the type typically associated with invasive 
catheters. The two-point support for the pad 80 provides gentle, even 
pressure tending to orient the collection device properly without 
excessive irritation. The perforating holes 46,48 allow air circulation 
and ventilation, thereby minimizing skin irritation. 
Furthermore, the disclosed embodiment is particularly simple to 
manufacture. It is formed of readily available materials, and the flat, 
plate-like structure of the discs 30,40 contributes to the remarkable 
simplicity of this embodiment. Furthermore, this embodiment is simple in 
structure in that the two discs 30,40 as well as the drainage tube 50 are 
all secured to the central urethral tube 20. The discs 30,40 are flexible 
and are movable independently of one another in view of their lack of 
interconnection except around the urethral tube 20. 
The disposable pad 80 provides important advantages in that it can be 
replaced readily and inexpensively, without replacing the discs 30,40 or 
the tube 50, if it is necessary to extend wearing time of the urinary 
drainage device. 
From the foregoing, it should be apparent that an improved urinary 
collection device has been described which is particularly simple in 
construction and effective in operation. Of course, it will be apparent to 
those skilled in the art that a wide range of changes and modifications 
can be made to the preferred embodiment described above. It is therefore 
intended that the foregoing detailed description be regarded as 
illustrative rather than limiting, and that it be understood that it is 
the following claims, including all equivalents, which are intended to 
define the scope of this invention.