U.S. patent number 3,661,155 [Application Number 05/013,684] was granted by the patent office on 1972-05-09 for female urinary incontinence device.
Invention is credited to Rosemary Lindan.
United States Patent |
3,661,155 |
Lindan |
May 9, 1972 |
FEMALE URINARY INCONTINENCE DEVICE
Abstract
A female urinary incontinence device including a pessary-like
support, a deformable loop extending outward from the support and a
flexible container removably secured to and opening through the
loop. The deformable loop is adapted to encircle the urethral
orifice of a wearer to hold the container in a desired position
when the pessary-like support is received and retained within the
vagina.
Inventors: |
Lindan; Rosemary (Cleveland,
OH) |
Family
ID: |
21761176 |
Appl.
No.: |
05/013,684 |
Filed: |
February 24, 1970 |
Current U.S.
Class: |
604/329;
128/835 |
Current CPC
Class: |
A61F
5/455 (20130101) |
Current International
Class: |
A61F
5/451 (20060101); A61F 5/455 (20060101); A61f
005/44 () |
Field of
Search: |
;128/127-128,294-295 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Claims
What is claimed is:
1. A female urinary incontinence device comprising a wholly
vaginal-insertable supporting portion resilient and flexible so as
to be distortable from a stable shape and capable of self-support
by expansion against surrounding vaginal wall portions, and means
carried by said supporting portion for extending about the urethral
orifice of a wearer.
2. A female urinary incontinence device comprising a wholly
vaginal-insertable pessary-like supporting portion resilient and
flexible so as to be distortable from a stable shape and capable of
self-support by expansion against surrounding vaginal wall
portions, and deformable means carried by said supporting portion
for extending about the urethral orifice of a wearer.
3. A female urinary incontinence device comprising a vaginally
insertable supporting portion resilient and flexible from a stable
shape, constructed to be received entirely posteriorly of the
urethral orifice of a wearer and to be resiliently retained in
place by expansion against surrounding vaginal wall portions, and a
urine receiver attached to and extending from said means, adapted
to be held adjacent the urethral orifice of a wearer.
4. A female urinary incontinence device comprising a wholly
vaginal-insertable pessary-like supporting portion, resilient and
flexible so as to be distortable from a stable shape and capable of
self-support by expansion against surrounding vaginal wall
portions, and a receiver portion carried by said supporting portion
for extending about the urethral orifice of a wearer, at least a
part of which receiver portion is essentially non-resilient and
deformable, said receiver portion being adapted to receive urine
voided by the wearer.
5. A device as set forth in claim 4 wherein the receiver portion
includes a receptacle portion.
6. A female urinary incontinence device comprising a vaginally
insertable ring portion, a deformable loop portion extending from
said ring portion, of a shape and size that will extend about the
urethral orifice of a wearer and adapted to be held in place by
said ring portion, and a flexible receiver portion connected to and
opening through said loop portion.
7. A female urinary incontinence device comprising a vaginally
insertable portion, a malleable or plastic loop portion extending
from said insertable portion, of a shape and size that will extend
about the urethral orifice of a wearer inside the labia minora and
adapted to be held in place by said insertable portion, and a
flexible receiver portion connected to and opening through said
loop portion.
8. A female urinary incontinence device comprising: a pessary-like
support, resilient and flexible so so to be distortable from a
stable shape and capable of self-support by expansion against
surrounding vaginal wall portions, adapted to be received wholly
within the vagina of the wearer; a loop portion projecting
outwardly from said support in an adjustable position adapted to
extend about the urethral orifice of the wearer within the labia
minora, adapted to extend partially into the vaginal introitus, and
capable of being deformed to and retaining a shape that will
substantially follow the contour of the body portion of the wearer
about the urethral orifice; and flexible urine-receiver connected
to said loop and opening therethrough.
9. A female urinary incontinence device comprising: a resilient
supporting ring adapted to be worn within the vagina of a human
female; a formable, i.e., plastic or malleable, loop connected to
and supported by said ring in a stable, adjustable, position, said
loop having a smaller periphery than said ring, a non-planar
configuration, extending outwardly from the ring with the general
disposition of the loop being angular with respect to the plane of
said ring so that the loop will be positioned during use to
encircle the urethral orifice of the wearer and extend partially
into the vaginal entroitus; and a urine-receiver connected to said
loop and having an opening communicating through said loop.
10. A female urinary incontinence device comprising: a resilient
supporting ring adapted to be worn within the vagina of a human
female; a formable, i.e., plastic or malleable, loop secured to and
supported by said ring in a stable, adjustable, position, said loop
having a smaller periphery than said ring, a non-planar
configuration, and extending outwardly from the ring with the
general disposition of the loop being angular with respect to the
plane of said ring so that the loop will be positioned during use
to encircle the urethral orifice of the wearer and extend partially
into the vaginal entroitus; and a flexible elongated receptacle
attached to said loop, a first opening at one end of said
receptacle communicating through said loop and a second opening
adjacent an opposite end of said receptacle adapted to be
selectively closed, and means attached to said receptacle to secure
the receptacle to the leg of a wearer.
11. A female urinary incontinence device comprising: a resilient
supporting ring adapted to be worn within the vagina of a human
female; a formable, i.e., plastic or malleable, loop secured to and
supported by said ring in a stable, adjustable position, said loop
having a smaller periphery than said ring, a non-planar
configuration, and extending outwardly from the ring with the
general disposition of the loop being angular with respect to the
plane of said ring so that the loop will be positioned during use
to encircle the urethral orifice of the wearer and extend partially
into the vaginal entroitus; and a flexible generally tubular
thin-walled receptacle having an opening at one end, the end
portion of the receptacle forming the open end extending through
said loop and being folded back over the loop, and adhesive means
temporarily securing the receptacle to the loop with the folded
over portion.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a urine receptacle for women.
2. Prior Art
Female urinary devices adapted to be worn by the patient and having
a urinary receptacle with or without a drain are known. Such
devices are intended to eliminate the need for catheterizing or
diapering female patients who are incontinent, due for example to
paralysis, senility, or other causes. Known devices of this type
are secured in place in various ways, including external straps or
vaginally insertable portions that resiliently clasp the body.
These devices require frequent cleaning or complete disposal after
use, with accompanying bother or expense, and risk displacement
when the patient moves or is moved. Furthermore, devices for this
purpose must readily accommodate the anatomical differences that
exist among individuals, especially in the specific location of the
urethral orifice. The failure of known devices to satisfactorily
fulfill the existing needs is evidenced by the generally continued
practice of catheterizing incontinent bed-ridden patients. A need
exists for a compact, easily constructed, economical, device that
can be reliably retained in place, that is comfortable to wear and
easy to clean, that accommodates the significant variations among
individuals in the specific location of the urethral orifice, and
that preferably includes a low-cost, disposable, receiver that is
readily removed from and replaced on a supporting portion of the
device.
SUMMARY OF THE INVENTION
Devices embodying the present invention include a vaginal
pessary-like support portion, a formable loop portion extending
therefrom and adapted to encircle the urethral orifice of the
wearer, and a urinary receiver portion extending from the loop
portion. The pessary-like support portion and the loop portion are
selected of a size to fit the particular wearer, with the loop
portion being of a shape and of a sufficient size to accommodate a
wide variation in the actual location of the urethral orifice and
to in part extend into the vaginal introitus. In addition, the loop
portion is constructed to be variably positioned and to be
conformed to a shape that follows the contour of the body to assure
a close fit of the receiver portion about the urethral orifice,
inside the labia minora. In the preferred embodiment, the
pessary-like support portion is a resilient ring that is easily
inserted and that expands after insertion to securely, reliably and
comfortably retain the loop portion and receiver portion in place.
The receiver portion may suitably be a tubular plastic or rubber
member with an upper urine-receiving opening. In the preferred
embodiment, the receiver is a receptacle or container and can
include a closable discharge orifice for convenience in emptying.
Alternatively, the receiver portion may be a part of or connected
directly to a drain, with little or no capacity for urine storage.
The upper portion of the receiver, defining the opening, is
preferably constructed to facilitate the temporary attachment and
removal of the receiver-receptacle to the loop portion.
The present device is readily fabricated from available items, for
example, a spring ring of the type used in diaphragms and coated
with latex is especially suitable as the support, the loop can be
formed of malleable wire with a plastic covering, and the receiver
portion can be made from thin rubber or plastic film, such as
polyethylene. The ring and loop are easily cleaned and can be
reused. The receiver portion can be conveniently and inexpensively
replaced, thereby eliminating the need for cleaning and minimizing
any risk of infection or objectionable odor. In use, the device
ensures separation of the periurethral area of urinary collection
from the perianal area, and prevents wetting of the skin of the
perineum, buttocks and thighs. If the receiver portion is in the
form of or includes a receptacle, it can be worn during the day and
can be emptied easily and conveniently when filled. When a larger
storage capacity is required, such as during the night, the
receiver-receptacle, if provided with a discharge orifice, can be
connected to a conventional leg bag or to a bed bag without
detaching or removing the device itself. If not provided with a
discharge orifice, or if a patient is completely bed-ridden, a
receiver without storage capacity and constructed primarily for
connection to a drain and drainage bag can be used.
The above and other features and advantages of this invention will
become more apparent from the detailed description that follows,
when considered in connection with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a diagram of a sagittal section of a human female pelvis
showing a urinary incontinence device embodying the present
invention in place;
FIG. 2 is a perspective view of a preferred embodiment of the
incontinence device of the present invention with a receptacle
portion disassociated from a supporting portion;
FIG. 3 is a partial perspective view similar to FIG. 2, showing the
receptacle portion attached to the supporting portion; and
FIG. 4 is a partial perspective view of another embodiment of the
present invention.
DESCRIPTION OF A PREFERRED EMBODIMENT
A female urinary incontinence device embodying the present
invention is indicated generally at 10 and is shown in place in the
sagittal section diagram of a female pelvis depicted in FIG. 1. The
device 10 includes a supporting portion 12 and a receiver portion
14. The supporting portion 12 is constructed to be at least
partially received within the vagina and serves to support and
secure the receiver portion to the wearer in proper position
adjacent the urethra, as shown in FIG. 1. The receiver portion 14
is in the form of a flexible container adapted to be removably
secured to the supporting portion in contact with the wearer around
the urethral orifice, inside the labia minora, and serves to
receive and collect urine. Alternatively, as shown in FIG. 4, a
receiver portion 14' can be constructed without storage capacity,
primarily for connection to a drain or conduit.
As best shown in FIG. 2, the supporting portion 12 includes a
vaginal pessary-like support 16 and an attached loop 18. In the
preferred embodiment shown, the pessary-like support is in the form
of a vaginal spring pessary, more particularly a spring diaphragm
ring 19 or the like, typically circular, and covered with a latex
coating 20 to reduce irritation to the wearer. As an alternative,
malleable or otherwise formable material can be used for the ring
and be formed to the particular shape required for the individual.
The attached loop 18 is somewhat smaller than the ring 16 and
extends outwardly from the ring. The loop 18 is constructed to
conform or to be conformed to the contour of the body about the
urethral orifice and to that end is, in the preferred embodiment,
made of a malleable or plastic material, i.e., a material capable
of being molded or shaped without breaking or returning to its
original shape, including material that may require the application
of heat or other softening agent to facilitate shaping. As shown,
the loop 18 is a malleable copper wire 21, with a tubular
protective plastic covering 23 or alternatively a latex coating or
other suitable padding over its surface and is secured to the ring
by its end portions 18a, 18b, which are spaced slightly apart, bent
tightly over the ring, and recessed with respect to the latex
coating 20 to avoid causing discomfort. Other known techniques for
securing the support 16 and loop 18 may be used, depending upon the
material from which the parts are made, to satisfactorily connect
the two parts. It would be appreciated that where the ring 16 is
not resilient, a one-piece construction can be utilized and could,
for example, be of plastic or the like. In use, the exact shape of
the loop must vary somewhat for different individuals and the
malleable or plastic material should be individually adjusted to
follow the contour of the patient's body about the urethral
orifice. In a typical adjusted position, as shown in FIGS. 1 and 2,
the ring 16 is substantially planar and loop 18 is elongated and
curved longitudinally to extend first downward and outward from the
ring 16 in the orientation of FIGS. 1 and 2 and then extends across
the plane of the ring so as to follow the adjacent contour of the
body of the wearer. In its general extent, the loop 18 is somewhat
angularly related to the plane of the ring in a typical adjustment,
as shown. The loop is substantially larger than the urethral
orifice and extends into the vaginal introitus or opening, as
illustrated in FIG. 1, and the ends 18a, 18b are spaced apart on
the ring 16 to provide a large opening to the receiver-receptacle
portion 14, all of which features serve to accommodate the
significant variations that exist in the location of the urethral
orifice among different individuals and to assure that the
receptacle is properly positioned regardless of such variations.
Typically, the ring 16 will be of a diameter between 35 to 100
millimeters and the loop will be of a length between 30 and 70
millimeters with a corresponding width at the point of maximum
separation of 15 to 40 millimeters, respectively, and of 5 to 10
millimeters, respectively, where connected to the ring. The loop
proportions remain about the same for various sizes and the largest
loops are typically used with the largest rings, although not
necessary.
The combination receiver and receptacle portion 14 includes a
disposable, flexible bag 22 of thin plastic or rubber, or the like.
In the preferred embodiment shown, the bag 22 is elongated,
generally tubular in form and completely open at one end 22a, which
is the upper end as worn and as shown in the orientation of the
drawings. The lower end 22b optionally includes an orifice 24 in
which case a piece of tubing 26 projecting through the orifice is
also provided. A fluid-tight seal is provided between the bag and
tubing piece, which can be accomplished with a heat seal, an
adhesive, or by applying a band that tightly encircles a part of
the bag about the tube. Alternatively, the tube portion can be
formed integrally with the bag. The tube can be occluded by a plug,
clamp or band (not shown) so that the bag retains any urine that
may be voided by the wearer, or can be connected to a standard
drainage bag.
The upper open end 22a of the bag is dimensioned to fit, when open,
within the loop 18. That is, the periphery of the bag at the open
end is approximately the same length as the periphery of the loop.
As best shown in FIG. 3, the bag is removably connected to the loop
with the upper end extending through the loop and an upper marginal
portion 22m folded over the loop and over a portion of the ring 16
between the ends 18a, 18b of the loop, and back down about the
upper part of the bag. This marginal portion is adhered to the
outside surface of the bag, as with a strip of pressure sensitive
adhesive tape 28. With this arrangement, the opening to the bag
follows the contour of the loop, which in turn is formed to closely
follow the contour of the wearer. As a result, the upper end of the
bag is in substantially fluid-tight relation with the area directly
surrounding the urethral orifice. Other means of securing the bag
may be used. For example, pressure sensitive adhesive may be
provided on the outer surface of the bag about the upper edge so
that the edge, when folded over the loop, will adhere to the
outside surface of the bag without tape. Alternatively, a
permanently attached skirt may be provided on the loop and the bag
may be adhesively affixed to the skirt, as by a continuous
circumferential strip of tape.
Two flaps 30, 32 project laterally from the bag 22 in opposite
directions approximately midway along the length of the bag for
attaching a strap 34. A slot 35 in the flap 30 and a slot 36 in the
flap 32 receive the strap 34, which is adapted to surround the leg
of the wearer and secure the portion of the bag 22 that depends
from the loop 18 in a relatively fixed position along the leg of
the wearer. Preferably, the strap is of plastic material and a
surface 34a that faces the leg of the wearer is coated or covered
with a soft fabric or fluff for comfort. Most advantageously, the
ends of the strap have interlocking fastening material 38, 39, such
as Velcro or the like, on surfaces that oppose each other when the
strap encircles the leg of the wearer to adjustably secure the bag
against the leg.
In use, the formable loop 18 is first shaped to conform to the
wearer and a bag 22 is attached by slipping the upper end 22a of
the bag through the loop, folding the top marginal portion 22m over
the loop and adhering it to the outside of the bag with adhesive,
preferable pieces of pressure sensitive adhesive tape 28 at spaced
locations about the periphery of the loop. The support portion 12,
is selected of the appropriate size for the wearer. This support
and the upper edge of the bag 22 along the loop 18 are lubricated
with a surgical lubricating jelly, preferably one containing a mild
antiseptic agent. The device is then grasped in the usual way for
pessary insertion, with the loop and receptacle towards the wrist
of the inserting hand, and inserted in the vagina like a cervical
diaphragm, i.e., to a position where the posterior lip of the ring
16 rests against the superior, posterior wall of the vagina
immediately posterior to the cervix uteri while the anterior lip
rests on the anterior, inferior vaginal wall, just inside the
vaginal orifice, as shown in FIG. 1. The loop 18, properly
adjusted, fits snugly around the urethral orifice and inside the
labia minora. This is not a watertight seal but, because the loop
and the mouth of the bag 22 are considerably larger than the
urethral orifice, there is no backflow of urine around the
periurethral skin, provided that an initial gravity flow into the
receptacle is provided by proper positioning. The device is removed
as required for cleaning and the attachment of a fresh bag. The bag
can be emptied through the tube 26 when required. For larger
capacity, the tube 26 can be attached to a conventional leg bag or
to a bed bag, without detaching or removing the device.
In the alternative embodiment shown in FIG. 4 the receiver portion
14' is funnel-like in shape with little or no storage capacity and
terminates in a tube portion 27'. The receiver portion can be made
of thin, flexible, rubber or plastic and can be attached to the
loop 18 in the same manner as the receiver portion 14, and the tube
portion 26' can be constructed in the same manner as the tube
portion 26. As shown, however, a modified construction is
contemplated in which the receiver portion 14' is of one-piece
construction, is relatively stiff about an upper edge portion 40 to
form the loop portion and is made of a material that is formable,
i.e., capable of being molded, such as readily softenable plastic
material. The tube portion 41 is secured in use to a drain tube 41
and separate receptacle.
From the above description it will be apparent that a reliable and
relatively comfortable female urinary incontinence device has been
provided, which is easily fabricated, which properly fits the
wearer, which facilitates the use of disposable bags, which can be
readily secured in place or removed, and which can be emptied
without removal.
While a preferred embodiment of this invention has been described
in detail, it will be apparent that modifications or alterations
can be made therein without departing from the spirit and scope of
the invention set forth in the appended claims.
* * * * *