U.S. patent number 3,554,184 [Application Number 04/721,959] was granted by the patent office on 1971-01-12 for pubo-vaginal incontinence device.
Invention is credited to Henry N. Habib.
United States Patent |
3,554,184 |
Habib |
January 12, 1971 |
PUBO-VAGINAL INCONTINENCE DEVICE
Abstract
A pubo-vaginal device for females afflicted with urinary
incontinence. The device consists of a silicone rubber unit
provided with an element adapted to be removably inserted in the
vagina and an exterior member integral with the element and
designed to lie against the pubic region of the wearer. A
supporting belt having straps secured to the member engaging the
pubic area maintains the unit in a location so that the element is
normally held in a position causing the same to exert an upward
thrust against the anterior wall of the vagina of sufficient
magnitude to block flow of urine from the bladder through the
urethra to the urethral opening.
Inventors: |
Habib; Henry N. (Kansas City,
MO) |
Family
ID: |
24899962 |
Appl.
No.: |
04/721,959 |
Filed: |
April 17, 1968 |
Current U.S.
Class: |
600/29; D24/125;
128/98.1; 128/835; D24/105; 128/DIG.25 |
Current CPC
Class: |
A61F
2/005 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61f 005/48 () |
Field of
Search: |
;128/1,160,168,98,295,346 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Claims
I claim:
1. A pubo-vaginal device for controlling female urinary
incontinence comprising:
an elongated resilient element adapted to be inserted in the vagina
of the incontinent female and removable therefrom at will;
a member connected to said element and cooperating therewith to
present a generally U-shaped monolithic unit with the element
disposed at an acute angle relative to the member, and adapted to
lie against the pubic region of the wearer of the device when the
element is fully inserted in the vagina, said element and the
member being resiliently interconnected and located in relative
dispositions prior to insertion of the element in the vagina of the
wearer causing the angle between the element and said member to be
less than the angle between the anterior wall of the vagina and
said pubic region of said wearer, said member being of a length
that upon full insertion thereof in the vagina, the member is
operable to hold the element in a position causing the same to
exert an upward thrust against the anterior wall of the vagina of
sufficient magnitude to block flow of urine from the bladder
through the urethra to the urethral opening; and
means joined to said member for normally holding the latter firmly
against the pubic region to retain the element in said position
thereof.
2. A device as set forth in claim 1, wherein said element is
positioned at an angle of about 60.degree. relative to the member
prior to insertion of the element in the vagina of the wearer.
3. A device as set forth in claim 1, wherein said member is of
generally L-shaped configuration and has an elongated primary leg
adapted to lie against the pubic region and a secondary leg shorter
than said primary leg joined to the normally outermost extremity of
the element for connecting the latter to said primary leg of the
member.
4. A device as set forth in claim 3, wherein said secondary leg is
of a length substantially equal to the length of the pubic
symphysis of the wearer of said device.
5. A device as set forth in claim 1, wherein said means for holding
the member comprises a belt for encircling the body above the
member and a series of straps suspended from the belt and joined to
said member to hold the latter against said pubic region.
6. A device as set forth in claim 5, wherein is provided front
straps secured to the normally uppermost end portion of the member
and to the front section of the belt, and rear straps secured to
the normally lowermost portion of the member and to the rear
section of the belt.
7. A device as set forth in claim 6, wherein said rear straps are
longitudinally elastic to facilitate removal of the element from
the vagina for voiding of urine without the necessity of removing
the device from the wearer's body.
8. A device as set forth in claim 6, wherein said member is
provided with holes therein for receiving the front and rear straps
respectively.
9. A pubo-vaginal device for controlling female urinary
incontinence comprising:
an elongated resilient element adapted to be inserted in the vagina
of the incontinent female and removable therefrom at will;
a member connected to said element in supporting relationship
thereto and adapted to be against the pubic region of the wearer of
the device when the element is fully inserted in the vagina, said
element and the member being of pliable synthetic resin material
and the element being of a length that upon insertion thereof in
the vagina and the member is in engagement with said pubic region,
the terminal end portion of the element is located to press against
the anterior wall of the vagina adjacent the junction of the
urethra and the bladder to push the base portion of the bladder
upwardly and forwardly toward the pubic bone in conjunction with
compression of the urethra to block flow of urine from the bladder
through the urethra to the urethral opening; and
means joined to said member for normally holding the latter against
the pubic region to retain the element in the urethra blocking
position thereof.
10. A device as set forth in claim 9, wherein said material is
silicone rubber.
11. A pubo-vaginal device for controlling female urinary
incontinence comprising:
an elongated resilient J-shaped element adapted to be inserted in
the vagina of the incontinent female and removable therefrom at
will;
a member connected to said element in supporting relationship
thereto and adapted to lie against the pubic region of the wearer
of the device when the element is fully inserted in the vagina,
said member being operable to hold the element in a position
causing the same to exert an upward thrust against the anterior
wall of the vagina of sufficient magnitude to block flow of urine
from the bladder through the urethra to the urethral opening;
and
means joined to said member for normally holding the latter firmly
against the pubic region to retain the element in said position
thereof.
12. A device as set forth in claim 11, wherein said element is
disposed with the opening to the loop thereof facing toward the
member and constructed and arranged to the terminal end portion
thereof to press against the anterior wall of the vagina at a
location to compress the urethra and prevent flow of urine
therethrough from the wearer's bladder.
Description
This invention relates to a pubo-vaginal device for controlling
urinary incontinence in women as well as young girls and has
particular application in those instances where corrective surgery
is not practical, must be postponed, simply will not be consented
to by the patient, or involves the problem of juvenile
enuresis.
Urinary incontinence in the female is a particularly vexatious and
troublesome problem because persons so afflicted have no ability to
retain any significant volume of urine in the bladder especially
under stress conditions which involve nothing more complicated than
standing and performing normal daily tasks that require moving
about in an upright stance. Even women who can walk about without
uncontrolled voiding of the bladder but are inclined to
incontinence will often involuntarily release urine from the
urethral opening when stress is placed on the area of the bladder
as for example by coughing or sneezing. Stress incontinence is
characterized by a spurt of urine from the urethra when any type of
pressure is placed on the bladder.
Although surgery is the preferred method of correcting female
urinary incontinence this is often not the practical solution,
especially where previous surgery has failed, the patient is
markedly obese and usually severely hypertensive thus making
surgical correction undesirable, and in small girls who suffer from
nervous disorders or paralysis of the muscles which control the
normal functioning of the bladder and urethra. In these instances,
it has heretofore been necessary for patients suffering from
urinary incontinence to wear pads in the nature of diapers or
employ a catheter connected to a bag suspended from the wearer's
leg or a belt around her waist. Pads are not a satisfactory
solution overall because they rapidly become moist, can cause
infection and inflammation of the skin that is exposed to the
urine, and also rapidly cause an undesirable uriniferous odor.
Catheters are not recommended because they also cause infection,
can result in the formation of stones in the urinary system,
product tissue irritation, can relatively easily plug up and are
not compatible with normal activity. In addition the patient must
return frequently to the hospital for removal and replacement of
the catheter in an effort to avoid a serious infection which would
rapidly become serious if left untreated.
Operations for the most part consist of a retropubic procedure in
which the urethra and vesico-urethra angle and anterior bladder
wall are attached to the periosteum of the pubis and the fascia of
the rectus with interrupted catgut sutures. postoperative effect of
this surgical procedure is elongation of the urethra and angulation
of the vesical neck.
There is a need though for means to control urinary incontinence in
women and young girls without resort to surgery for reasons noted
above as well as during the time period which may elapse before an
operation can be performed. This time factor is often dictated by
the convenience of the patient, availability of hospital beds and
the schedule of the surgeon even though it is contemplated that an
incontinent condition ultimately be repaired by surgery.
It is therefore the primary object of the present invention to
provide a pubo-vaginal device for controlling various types of
urinary incontinence in females and which in various embodiments
thereof is effective to control such incontinence notwithstanding
differences in their age and physical condition. Thus, the device
may be used by patients awaiting surgery as well as those who
cannot tolerate surgery for medical or psychological reasons. In
addition the device may serve as a means for controlling juvenile
enuresis and as a test for patients whose urinary incontinence is
mechanical and who are definite candidates for surgery but require
detailed medical examination and observation before it can be
definitely determined that the person is a candidate for corrective
surgery.
It is another very important object of the invention to provide a
resilient pubo-vaginal unit for a device useful in the treatment of
urinary incontinence and having an element adapted to be inserted
in the patient's vagina and supported therein by an external member
connected thereto that is suspended from a body encircling belt and
strap assembly in disposition such that the vaginal element is
disposed to produce an upward thrust on the anterior wall of the
vagina in a direction and with sufficient force to block flow of
urine from the bladder to the urethral opening while the device is
in place.
It is another important object of the invention to provide a
pubo-vaginal device which may be constructed of a highly stable,
resilient, nonallergenic and nonirritating synthetic resin material
such as silicone rubber which has been fully approved for use in
medical applications and is known to be noninjurious to tissue even
if used thereagainst for extended periods of time.
Another important object of the invention is to provide an
incontinence control device which may be easily placed in position
by the patient herself without assistance from a doctor after
initial fitting thereof and which may be just as easily removed for
voiding of the bladder, or when retiring for the evening.
An equally important object of the invention is to provide a
pubo-vaginal incontinence device which is adapted to be constructed
of a resilient nonirritating, nonallergenic synthetic resin
material such as a silicone rubber to thereby permit construction
of each device by the attending physician so that it will very
precisely fit the individual patient for which it is sized.
A still further important aim of the invention is to provide a
device for controlling female urinary incontinence which may be
constructed in various forms depending upon the physiological
condition of the particular patient causing the incontinence
problem and which is operable to either compress the urethra so as
to block flow of urine therethrough, to close the vesical-urethra
junction and thereby prevent release of urine from the bladder, or
both as dictated by the particular circumstances unique to each
individual patient.
A further important object of the invention is to provide a device
as described which is completely effective to prevent involuntary
release of urine from the person's bladder during wearing of the
device and which may be manufactured and distributed at a
reasonable cost thus making the assembly available to all patients
afflicted with the problem without significant regard to their
financial status.
In the drawing:
FIG. 1 is a perspective view of a pubo-vaginal device constructed
in accordance with the preferred principles of the present
invention and showing the resilient unit having an element adapted
to be received in the wearer's vagina and an external member
engageable with the pubic region to retain the element in blocking
relationship to the flow of urine from the bladder to the urethral
opening, and with preferred supporting belt and strap structure
being illustrated for retaining the resilient unit in an operative
position;
FIG. 2 is an essentially schematic representation of a sagittal
section of an incontinent woman wearing the resilient unit of the
pubo-vaginal device and showing the relationship of the vaginal
element to the external pubic member portion thereof to prevent
flow of urine from the bladder through the urethra to the urethral
opening;
FIG. 3 is a side elevational view of a modified pubo-vaginal unit
constructed in accordance with the present invention with the
supporting belt and strap structure therefor not being shown for
clarity of illustration;
FIG. 4 is a schematic diagram similar to FIG. 2 and showing a
sagittal section of a incontinent woman wearing the unit of FIG.
3;
FIG. 5 is a perspective view of a pubo-vaginal unit generally
similar to the one shown in FIG. 1, but in this case employing
different means for selective securing of the belt and strap
support structure thereto; and
FIG. 6 is a side elevational view of a pubo-vaginal resilient unit
of the type especially usable with young girls suffering from
enuresis or nervous disorders that result in urinary
incontinence.
A pubo-vaginal device made in accordance with the preferred
embodiment of the invention is illustrated in FIGS. 1 and 2 and
broadly designated by the numeral 10. The principal components of
device 10 comprise a resilient unit 12 and supporting structure 14
therefor adapted to encircle the body of the wearer.
The unit 12 is generally U-shaped and has an elongated, smooth
surfaced, preferably transversely circular element 16 integral with
an external member 18 of generally L-shaped configuration and
thereby having an elongated primary leg 18 adapted to lie against
the pubic region in form engagement therewith, along with an
intermediate secondary leg 18b which normally spans the pubic
symphysis. The member 18 is also preferably smooth surfaced and of
a shape to overlie the pubic region directly adjacent to the pubic
bone thereunder.
Structure 14 for supporting the resilient unit 12 comprises an
elastic belt 20 adapted to encircle the wearer at the top of the
hips. The rear strap assembly 22 is of elastic material which
extends through an opening 24 in secondary leg 18b of member 18 at
the zone of juncture thereof with element 16. As a consequence,
strap assembly 22 has a pair of separate sections 22a and 22b which
are attached to the rear part of belt 20 by fasteners 25.
The front strap assembly 26 extends through an opening 28 in the
normally uppermost end of leg 18a of member 18 and has a pair of
spaced sections 26a and 26b slidably joined to the front part of
belt 20 for sliding movement therealong. The ends of sections 26a
and 26b are looped over belt 20 and adjustably received in retainer
buckles 26c. Snap fasteners 26d interposed in sections 26a and 26b
below buckles 26c permit selective disconnection of the lower parts
of sections 26a and 26b from belt 20.
It is preferred that the unit 12 be constructed of a resilient
synthetic resin material of the nonirritating, nonallergenic type
which has been approved for use in medical applications where it is
in direct contact with tissue and especially moist, easily
irritated tissue of the type found within the vaginal cavity. An
especially useful synthetic resin for this purpose has been found
to be a product sold by Dow Corning Corporation, East Lansing,
Michigan under the trade designation of "Silastic" type No. 802
which is produced from S-2000 grade "Silastic" dough. This product
may be purchased in the form of a block one-half inch thick and
measuring 31/2inches by 4 inches. A block of this size is ideal for
preparing unit 12, or the synthetic resin material may be molded in
roughly the correct, generally U-shaped configuration and then
carved to size. In both instances, the preferred material readily
lends itself to being carved with a surgical knife to the desired
final shape and size.
The resilient unit 12 is initially constructed so that there is
approximately a 60.degree. angle between element 16 and primary leg
18a of member 18. However, this angle increases upon insertion of
element 18 into the vaginal cavity which is an important feature of
device 10 so that proper pressure is exerted on the anterior
vaginal wall as will be hereinafter explained.
In preparing the pubo-vaginal device 10 for an individual patient,
the physician first makes a digital examination to determine the
relationship of the base of the patient's bladder relative to the
entrance to the vaginal cavity. After locating this point and
determining the distance thereof from the opening of the vagina,
the physician then shapes the element 16 so as to present a smooth
outer surface preferably somewhat circular in cross section and of
a length so that the outer extremity of the element is adapted to
engage the anterior wall of the vagina adjacent the junction of the
patient's bladder with the urethra. The relationship of element 16
in preferred form to the bladder and urethra are illustrated in the
sagittal section of FIG. 2.
In the use of device 10, the belt 20 is slipped into position and
element 16 inserted into the vagina with L-shaped member 18
positioned in firm engagement with the pubic area directly
overlying the pubic bone. The strap sections 26a and 26b are drawn
downwardly through the buckles 26c until the straps force the unit
12 into firm engagement with the pubic region as best shown in FIG.
2. The straps 26 are also shifted along the front section of belt
20 until a comfortable fit is obtained. As a consequence, the
element 16 is forced into engagement with the anterior wall surface
of the wearer's vagina and member 18 is pressed into firm
engagement with the pubic region in disposition where support
therefor is provided by the pubic bone. The element 16 is thus held
in a position causing the same to exert an upward thrust against
the anterior wall of the vagina of sufficient magnitude to block
flow of urine from the bladder through the urethra to the urethral
opening. This mechanical blocking action is believed to occur
because of (1) obstruction of the urethra by pressure thereagainst
especially at the part thereof which merges with the opening into
the bladder, (2) vesical-urethra kinking with the outer extremity
of element 16 producing a forward and upward thrust against the
base of the bladder, and (3) simple support for the bladder which
is especially useful when it approaches being filled to
capacity.
It is important that the supporting structure 14 hold the L-shaped
member 18 in a fixed position against the pubic region of the
wearer of device 10 so as to prevent movement of element 16 out of
critical position thereof blocking flow of urine from the bladder
through the urethra. This blockage is enhanced not only because of
the disposition of the element 16 as shown in FIG. 2, but also by
virtue of the fact that even though element 16 integral with leg
member 18 is held relatively immobile, the element 16 is able to
move slightly as necessary to compensate for changes in the angle
of the vagina during normal movements of the wearer in performing
functions such as bending over, sitting down or lifting
objects.
The connection of rear strap sections 26a and 26b to secondary leg
18d of unit 12 adjacent the zone of merger thereof with element 16
is especially important because the tension on the unit provided by
the elastic straps causes the element 16 to be slightly rotated
counterclockwise viewing FIG. 2 upon insertion of the element in
the vaginal cavity. As a result, the outer end of element 16 is
moved toward the anterior wall of the vagina a sufficient extent to
produce the necessary upward and forward forces on the urethra and
junction thereof with the bladder to effectively block flow of
urine through the urethral canal.
After fitting of the device 10 by the physician, he makes certain
that it is effective by having the patient cough or simulate a
sneeze to place stress on the muscles surrounding the bladder and
urethra. If the device is of proper size and positioned in a
correct location, no urinary leakage will occur.
The unit 12 may be easily shifted to a position for voiding of the
bladder by simply disconnecting fasteners 26b and moving the unit
12 downwardly until the element 16 is completely out of the vagina.
The resilient straps 22a and 22b permit such downward movement of
the unit 12 while at the same time providing the necessary bias on
member 18 when the unit 12 is in an operative disposition.
The modified pubo-vaginal device illustrated in FIGS. 3 and 4
utilizes supporting structure similar to structure 14, but employs
a resilient U-shaped unit 112 of somewhat different shape than unit
12. The L-shaped member 118 of unit 112 is similar to that found in
unit 12, but the J-shaped element 116 is located so that the
opening to the loop thereof faces the rear side of the juncture
between primary leg 118a and secondary leg 118b of member 118. Unit
112 is also preferably constructed of the silicone rubber material
described above and in this case, the outer part of element 116 is
shaped so as to provide pressure against the anterior wall of the
vagina in compressing relationship to the urethra below the
junction thereof with the bladder. As a consequence, the urethra is
blocked off so that urine cannot flow therethrough but an upward
compressive force is not placed against the junction of the bladder
with the urethra as is the case with element 16 of unit 12. Unit
112 has particular application where the patient has a spastic
bladder and the compression of the urethra is adequate to prevent
involuntary flow of urine from the urethral opening.
The resilient unit 212 shown in FIG. 5 is of a shape similar to
that of unit 12 except that flat segments 218c and 218d are
provided on the primary leg 218a and secondary leg 218b of member
218. These flat segments serve as mounting points for the male
sections 230 of conventional snap fasteners, the female sections of
which are mounted on the straps of the supporting structure
therefor similar to structure 14. The use of snap fasteners has a
special utility where essentially nonresilient straps are used for
suspension of the unit 212 from a belt, to permit selective
disengagement of the straps from the resilient unit 212 for removal
thereof.
The resilient unit 312 of FIG. 6 comprises another embodiment of
the invention and which has a special utility in the case of
urinary incontinence in young girls caused by nervous disorders or
paralysis. In addition, device 312 has utility in alleviating the
problems associated with juvenile enuresis.
In the case of unit 312, the element 316 is at a much more acute
angle relative to the L-shaped member 318 and is of much smaller
size to be accommodated in the vaginal cavity of the small child.
Preferred means for supporting unit 312 is again an assembly
similar to supporting structure 14. Note should particularly be
taken of the relatively short secondary leg 318b connected to the
primary leg 318a of member 318 to accommodate the relatively small
pubic area of the small girl suffering from any type of urinary
incontinence.
Various grades of the silicone rubber material may be used
depending upon the pressure needed to block the urethra and the
proper hardness may be employed for a particular application. For
example, where a small and thin vaginal element 16 is required as
for example in the case of element 316 of unit 312, a somewhat less
resilient silicone rubber composition may be used with relatively
firm "Silastic" type No. 803 being preferred. In all instances
though, the material should lend itself to sizing for each patient
based on vaginal examination to determine the most effective place
for application of pressure to the urethra or bladder or both.
* * * * *