Note: Descriptions are shown in the official language in which they were submitted.
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A DEVICE FOR CONTROLLING
FEMALE INCONTINENCE
Field of the Invention
This invention relates to medical devices used
for controlling ~rinary stress incontinence in
women, and more particularly to a device totally
inserted into the vaginaO By supporting the vaginal
tissue on each side of the urethra, the device will
ensure that the tissue, which is beyond the urethra
as seen from the abdominal cavity, is stretched
d~lring an increase in the intra-abdominal pressure.
The stretching makes the tissue more capable in
offering counter pressure, whereby an increased
intra-abdominal pressure will be more completely
transmitted down to the stretched tissue, and the
tissue above, including the upper urethra, will be
affected by the increased intra-abdominal pressure.
This will help to prevent the difference in pressure
existing at rest, between upper urethra and bladder,
from being reduced during coughing or other activity
which causes a sudden increase in intra-abdominal
pressure. If the patient is continent at rest, she
should remain 80 regardless of how intra-abdominal
pres3ure is altered.
Back~round of the Invention
Urinary incontinence in women is a common
problem, potentially serious from a social point of
view. Repeated loss of urine may cause skin
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irritation, and may be an embarrassment to the
woman. Most often the incontinence is of the stress
type, characterized by a loss of urine during
coughing, sneezing, laughing and physical exercise.
Sometimes the problem will only occur occasionally
when intra-abdominal pressure is raised excessively.
In other cases, a minimally exerted stress will
cause incontinence, particularly when standing.
One way of coping with urinary incontinence is
to use absorbent pads in the genital region.
However, these pads are unacceptable due to the
limited volume of urine they can absorb, the
associated odor, and the high probability that skin
infection and inflammation will follow.
It is desirable to control stress incontinence
and thus it is necessary to consider now continence
is achieved. Urinary continence is achieved by
pressure in a section of the urethra being higher
than what it simultaneously is in the bladder. ~t
rest pressure is higher in the upper third of the
urethra than in the bladder due to tone of the
urethra's circular smooth musculature which acts as
* sphincter. An increase in intra-abdominal
pressure, as occurs during coughing, will normally
raise pressure equally in the upper urethra and the
bladder. Pressure thereby stays higher in the upper
urethra than in the bladder and the patient remains
continent. With increasing age, causing tissue
atrophy, and as a result of childbirth, there may be
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tissue derangement so that when pressure is suddenly
raised in the abdomen, it will no longer be fully
transmitted to the urethra as it is to the bladder.
1'he difference in-pressure between urethra and
bladder may then be reduced to zero. Nothing is
then preventing leakage of urine, and therefore
incontinence i5 manifested.
In the past stress incontinence has been
controlled through the application of the Rennedy
stitch which is described at column 1, lines 44 et
seq. of U.S. Patent No. 4,139,006. The Kennedy
stitch does not provide the necessary support to the
anterior wall of the vagina, which support has been
lost due to a diminished muscle tone, a tissue
atrophy, and in some cases due to the trauma of
childbirth. Rather, the Kennedy stitch reduces the
width of the urethra, thereby making incontinence
less likely.
It has been proposed that urinary incontinence
can be regulated by a device which alters the
angular relationship between the urethra and
bladder. Thus, it has been observed that by making
the urethrove~ical angle, i.e., the angle between
the urethra and the bladder base, more acute,
urinary incontinence can often be reduced. U.S.
Patent Nos. 3,705,575 to Edwards and 4,139,006 to
Corey are based on this principle. Edwards
disclose~ an incontinence device that changes the
urethrovesical angle. The device includes a first
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member which is adapted to fit within the vagina and
which applies pressure to the urethra and a second
member adapted to bear against the external pubic
area of the female body. However, this device is
uncomfortable to wear and may cause irritation to
the vaginal mucosa. Furthermore, the device is not
likely to stay in place when inserted into the
vagina just inside the introitus and is not
inflatable, and therefore, can not be expanded to
give just the right amount of support.
Corey, in U.S. patent No. 4,139,006, discloses
a device completely inserted into the vagina for
displacing a surface of the anterior wall of the
vagina, and an intermediate section of the urethra
adjacent thereto, toward the pubic bone, thereby
reducing the urethrovesical angle for restoring the
patient's natural control of the flow of urine
through the urethra from the bladder to the urethral
opening. However this device is not likely to stay
in place when inserted into the vagina only just
inside the introitus, is not inflatable and,
therefore, can not be expanded to give just the
right amount of support.
Another incontinence device is that disclosed
25 in U.S. patent No. 3,554,184 to Habib. The
incontinence device is formed from silicon rubber
and designed to be inserted into the external region
of the vagina. The patient must wear a belt,
coupled to the member, whereby the latter is thrust
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against the anterior wall of the vagina with a
sufficient magnitude to efficiently block the flow
of urine through the urethra. However, besides
involving the wearing of an uncomfortable belt, the
device is only partially contained within the vagina
and may therefore cause irritation of the labia.
Bonner in U.S. patent No. 3,646,929 discloses a
female incontinence device which comprises a
generally flat support adapted for insertion into
the vagina. A flexible diaphragm is coupled to the
support and is inflated to expand in an upward
direction against the anterior wall of the vagina
for applying pressure thereupon to block the
urethra. However, this device blocks all flow of
urine from the bladder. Therefore, when a patient
needs to urinate the device must be deflated and
then inflated after urination.
As previously indicated, surgery offers another
solution to the problem. Almost all surgical
procedures for controlling stress incontinence
improve support to the upper urethra which is
thereby better exposed to changes in intra-abdominal
pressure. When pressure is raised in the abdomen by
a stress condition such as coughing, the increased
pressure will be transmitted after the operation,
not only to the bladder, but also to the same, or
almost the same, extent to the upper urethra. Thus,
a higher pressure in the upper urethra than in the
bladder will be maintained regardless of pressure
changes in the abdomen. Digital support on each
side of the upper urethra, Bonney's maneuver, has
often been tried by the physician examining prior to
surgery. If such support inhibits incontinence
caused by coughing it has been felt that the patient
would be a good candidate for surgery. However,
surgical procedures are often not to be considered
due to the patient's age or medical status.
Accordingly, it is desirable that a device be
developed for controlling urinary incontinence which
overcomes the problems associated with the prior art
devices disclosed herein, and which can be used
temporarily until an operation can be carried out,
or permanently if the patient is a poor operative
risk. The device should permanently offer the same
support as the examining physician's fingers are
offering when Bonney's maneuver is carried out.
Objects and Summary of the Invention
The primary object of the present invention is
to provide an inflatable device which is completely
inserted into the vagina and will control female
stress incontinence, which device will prevent
incontinence during stress conditions such as
coughing, sneezing, laughing and physical exercise
by improving transmission of intra-abdominal
pressure to the upper urethra.
Another object of the present invention is to
provide such a device which does not exert a
permanent pressure over the urethra and therefore
does not require removal or deflation to allow
urination.
Another object of the present invention is to
provide such a device which exerts support on each
side of the upper urethra.
Another object of the present invention is to
provide such a device which is adjustable by
inflation and thereby can be given a large volume
and size when inserted but a reduced size during the
actual insertion or removal.
Another object of the present invention is to
provide such a device which is malleable so as to
retain some shape and stiffness when not inflated.
Another object of the present invention is to
provide an easily insertable device cau~ing minimal
discomfort and irritation to the patient.
Another object of the present invention is to
provide a device of such a shape that it will grip
to the walls of the vagina, thereby restricting the
relative movement therebetween.
Another object of the present invention is to
provide a device which is of such shape that it will
allow drainage from the cervix to the introitus of
the vagina.
Another object of the present invention is to
provide a device which will counteract prolapse of
the uterus and vagina.
The device in accordance with the present
invention does not primarily intend to affect the
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urethrovesical angle, nor exert a persisting
pressure over the urethra, but it increases
transmittance of intra-abdominal pressure to the
upper urethra. More specifically, this invention
s operates by providing adequate support to the
anterior wall of the vagina so that when abdominal
pressure is suddenly raised, as it will be during
coughing, the increase in pressure of this stress
will be transferred to the anterior wall of the
vagina, which then provides adequate support to the
urethra. The circular muscles are then able to
maintain a pressure in the urethra which is higher
than in the bladder. Stated another way, the device
of this invention will ensure that when pressure is
lS raised in the abdomen, it will be increased, not
only in the bladder, but also in the urethra so that
pressure remains higher in the urethra than in the
bladder, and stress incontinence will not occur. By
having such an effect, "closure pressure" (defined
herein as the greatest difference between
intra-urethral and simultaneous bladder pressure)
will remain positive regardless of the changes in
the intra-abdominal pressure, and continence will be
preserved.
The female incontinence device is inserted into
the vagina for controlling female stress
incontinence. The device includes an annular or
oval inflatable body section and two projections for
supporting the vaginal tissue on each side of the
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upper urethra so that the tissue between the
projections of support will be stretched and can
offer counter pressure when there is a sudden
increase in intra-abdominal pressure. This will
preserve continence since the urethra between the
points of support will be more readily exposed to
increase in abdominal pressure, thereby causing
closure pressure to remain positive. The body
section has means for deflation and inflation.
Because every human body is diÇferent, it is
necessary that the Applicant' 5 design be
manufactured in different sizes. The sizes in
between can be obtained by varying the inflation
pressure. The device is effectively inserted into
the vagina when it is deflated. When in the vagina,
it is partly inflated and placed in the proper
location. Once digital examination has assured that
the device is correctly located, the inflation is
completed, as desired. The effectiveness of the
device can be tested by the patient herself. With
the bladder full, the patient can make sure that she
has become continent even when she is coughing
strenuously. If not completely continent, she may
have to adjust the position of the device or the
inflation pressure used. To keep the device in the
position found to be optimal, the exterior surface
is roughened, which reduces movement between the
device and the vaginal wall.
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In the Applicant's design a hammock-like
support is provided by the two projections and the
tissue in between. The urethra is resting in this
hammock, which causes an increased intra-abdominal
pressure to reach the urethra more completely. It
may be desirable to modify the support provided by
the two projections. This can be achieved if the
projections have a wall thickness which is less than
that of the remaining body section. The two
projections may then enlarge more than the body when
pressure is raised during inflation. Alternatively,
the projections may have the shape of bellows. The
body section includes a roughened surface around the
exterior portion thereof, capable of contacting the
walls of the vagina to restrict the relative
movement of the body section when positioned within
the vagina. The body section also includes an
aperture extending therethrough which reduces the
total volume of the device, allows drainage of
uterine secretions, and further restricts the
relative movement of the body section when
positioned within the vagina. The means for
inflating and deflating the body section include a
tubing extending from the body section, and a valve
housed within the tubing or within the body section
for regulating the flow of air into and out of the
body section. For deflation of the device, the
valve can be opened by digital compression carried
out by an attendant or the patient herself.
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Thç device described in detail, for which
patent is applied, is similar in shape to rings used
for the control of prolapse, uterine or vaginal~
There is a significant difference though, in that
the Applicant's design has projections that
specifically support the anterior vaginal wall on
each side of the urethra.
The above will become more apparent to those
skilled in the art after a consideration of the
following detailed description taken in conjunction
with the accompanying drawings in which a preferred
form of this invention is illustrated.
Brie-DescriPtion of the Drawinq
FIG. l illustrates a sagittal section of the
female pelvis.
FIG. 2 is a view similar to FIG. l showing the
device of the presen~ invention within a vagina
FIG. 3 illustrates a top view of the device of
the present invention when inflated.
FIG. 4 is a view taken generally along the line
4-4 in FIG. 2.
D~etailed Description of the Preferred Embodiment
The device in accordance with the present
invention is used in controlling urinary
incontinence in women. The device is completely
inserted into the vagina for supporting the tissue
of the vaginal wall on each side of the upper
urethra so that, when the intra-abdominal pressure
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is suddenly increased, the vaginal tissue between
the points of support will be stretched like a
hammock and the tissue will offer counter pressure
to the increasi-ng intra-abdominal pressure. This
will allow intra-abdominal pressure to be
transmitted to the upper urethra so that the closure
pressure, i.e., the greatest difference between
intra-urethral and simultaneous bladder pressure,
will remain positive regardless of the changes in
the intra-abdominal pressure, and continence will be
preserved. The support afforded to each side of the
urethra allows the tissue between the points of
support to function like a hammock such that the
tissue will offer counter pressure to sudden
increases in intra-abdominal pressure which occur
during coughing, sneezing, laughing and physical
exercise. Thus, the urethra, resting in this
hammock, will be more completely affected by
increases in intra-abdominal pressure and retain a
pressure greater than in the bladder, such that the
closu~e pressure will remain positive and continence
will be preserved.
With reference to FIG. 1, there is shown a
sagittal section of the female pelvic organs which
contact the device of the present invention. The
organs of interest include the vagina 10, the uterus
12, the cervix 14 at the lower end of the uterus 12
opening into vagina 10, the bladder 16 and urethra
18. Bladder 16 stores the urine and passes it
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through the urethra to the urethral opening 20 for
discharge. When due to an activity such as
coughing, sneezing, laughing or physical exercise,
intra-abdominal pressure is suddenly raised,
pressure in the bladder 16 is totally affected by
this pressure increment. In women who suffer from
stress incontinence the increased intra-abdominal
pressure is only incompletely transmitted to the
urethra and, at the peak of the stress situation,
pressure is no longer higher in the urethra 18 than
in the bladder 16, as it normally should be.
Consequently there is nothing to prevent the urine
from being extruded out through the urethral opening
20. The present device will correct this situation.
It will improve transmittance of intra-abdominal
pressure to the urethra which will thereby maintain
a pressure which is higher than that in the bladder
regardless of changes in intra-abdominal pressure.
With reference to FIGS. 2-4, the device of the
present invention is indicated generally at 22 and
includes a body section 24 having the form of a
doughnut or ring, circular or oval. Body section 24
defines a roughened surface 28 on the axially
exterior portion thereof and an axially inner
surface 30. Surface 30 defines the outer diameter
of an aperture 32 which extends through body section
24. The aperture 32 allows drainage to migrate from
the uterus and out of vagina 10. A projection
section, indicated generally at 36, is attached to
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and is formed as an integral part of body section 24
and includes two anterior projections 34 spaced
along external surface 28 of body section 24. While
the projections 34 described herein are formed
integral to the body section 24, it is within the
scope of the present invention to have projections
which are separately attached to body section 24.
The projections 34 provide support to the tissue of
the anterior vaginal wall 38 (FIG. 4) on each side
of the urethra 18 when device 22 is inserted in the
vaglna .
Projections 34 form a U-shaped surface 40
therebetween. Projections 34, the contour of the
~-shaped surface 40 and the overall dimensions of
body section 24 are constructed to be comfortable
and compatible with the structures of the female
anatomy. The device 22 is molded as a smooth single
unit composed of a pliable, resiliently deformable
material such as an elastomer. The material should
include characteristics which will readily deform
when device 22 is folded for insertion within vagina
10 and during normal physical activity, but
continually provide the required support to the
tissue of the anterior vaginal wall 38 on each side
of the urethra 18. When the device is installed,
there may be a void 42 as shown in FIG. 4 between
the projections 34.
With reference to FIG. 3, an inflation means,
indicated generally at 43, is provided. The
,
inflation means is operated by a syringe or a pump
(not shown) and includes a tubing 44 connected to
body section 24 at circumferential surface 30 and a
one-way ball valve 46. Tubing 44 may extend outside
the vagina for easy access. If so, it may have a
spiral "memory'l, i.e., it is made of elastic
material. At rest it forms a spiral close to the
body section 24 in the vagina. The valve 46 at the
end of tube 44 can be pulled through the introitus.
When the valve is released again after inflation or
deflation, the tube returns inside the vagina.
Alternatively, once the device 22 has been inflated,
tubing 44, which originally is of considerable
length to allow easy inflation, may be shortened by
being cut off with scissors. For deflation, the
valve 46 can be opened by digital compression
carried out by an attendant or by the patient
herself. It is understood that an alternative valve
mechanism is possible and that any sufficient method
of inflating and deflating body section 24 can be
substituted herein and still be within the scope of
the present invention.
The device 22 is inserted within vagina 10 so
that projections 34 are on each side of the urethra
18 and exert no pressure on urethra 18. Projections
34 will offer support to the connective tissue of
the anterior vaginal wall which is between the
urethra and the vaginal mucosa. This tissue will
act like a hammock and offer counter pressure to an
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increasing intra-abdominal pressure. Further,
projections 34 enhance the natural gripping ability
of the vaginal walls for retaining the device 22 in
its proper location during most types of physical
activity.
With reference to FIG. 2, the device 22 may be
inserted into the vagina 10 in the doctor's office
or by the patient at home. First, the doctor (or
patient) grasps body section 24 of device 22 and
squeezes the body section which will fold sagittally
along the major diameter thereof. The device will
then, when deflated, have the shape of a section of
a sphere. The concavity of the section should be
facing the patient when she, her doctor or nurse
introduces the maximally deflated device into the
vagina until it reaches the posterior fornix. The
insertion is similar to that of a diaphragm. As
device 22 approaches the proper location, the device
is partially inflated and one should make sure that
the projections 34 are on each side of the urethra
and that the ring rests on the pubic arch and the
levator muscles. When the correct position is
secured device 22 is further inflated until it is
noted that coughing no longer causes leakage. The
diameter of device 22 may vary between 50 and 95 mm
depending upon its original size and the degree of
inflation.
` The supporting pressure exerted against the
vagina, laterally and adjacent to each side of the
urethra, will allow the tissue 42 between the
vaginal mucosa and the urethra 18 to function like a
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hammock, as shown in FIG. 4, and the tissue will
offer counter pressure when intra-abdominal pressure -
is suddenly raised as it is during coughing,
sneezing, laughing-and physical exercise. Thus, the
intra-abdominal pressure is transmitted to the upper
urethra so that the closure pressure remains
positive regardless of changes in the
intra-abdominal pressure, causing continence to be
preserved.
The patient may proceed with normal physical
activities characteristic of everyday life after
device 22 is inserted within the vagina.
Consequently, the patient may participate in
physical activities which formerly would have been
prohibited due to the danger of an unanticipated
loss of urine responsive to the increased
intra-abdominal pressure caused by the stress
activities. The device may be worn continuously
within the vagina of the patient without the removal
thereof when the patient desires to urinate. For
cleaning the device can be removed at the end of the
day or, like other prolapse devices, it can be
retained for up to one month.
It will be understood that the foregoing
description and illustrations are by way of example
only and that such modifications and changes as may
suggest themselves to those skilled in the art are
intended to fall within the scope of the present
invention as defined by the appended claims.
What is claimed is:
