Note: Descriptions are shown in the official language in which they were submitted.
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TITLE: FEMALE POSTERIOR WALL PROSTHESIS
BACKGROUND - FIELD
This application relates generally to medical devices, particularly to a
prosthesis constructed to
duplicate the posterior vaginal wall.
BACKGROUND - PRIOR ART
After an episiotomy, vaginoplasty or vaginal tear, the remaining healed scar
on the posterior
vaginal wall can be painful or the area on the posterior vaginal wall can be
hypersensitive. There is a
need for a sensitive area covering device that can be worn on the posterior
vaginal wall during coitus
to reduce the friction on this area to help with the hypersensitivity in this
area. Standard medical
practice when performing an episiotomy is to cut from the introitus towards
and into the perineum.
These areas are the site of various surgical and non-surgical traumas
comprising tears, occlusions,
sutures, scars, sores, genital warts and genital herpes all of which can cause
the posterior vaginal wall,
the introitus and the perineal area to be hypersensitive.
In addition, a woman's vagina and vaginal entrance naturally differ in size
from person to person.
Factors such as aging, overstretching from childbirth or sexual activities can
further cause the vagina
and vaginal entrance to lose elasticity. To help tighten her vagina, a woman
has a few options
available to choose from. These options have varying degrees of success and
risk.
Since early times, some women have used creams that claim to tighten the
vagina. Evidence
shows that noticeable tightening effects of these ointments are considered to
be ineffective.
Application of the cream to the interior walls of the vagina is difficult,
embarrassing, and must be
properly timed to correspond with sexual intercourse. Some of the creams
contain benzocaine, alum
or petroleum jelly, none of which are recommended for being inserted into the
vagina.
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Another prior art alternative is to perform an alum douche. Alum douches are
not recommended
by doctors, can be irritating and are associated with increased risk of pelvic
and vaginal infections.
Alum is an astringent that acts to contract the vagina walls, but there is no
way to judge how long the
constriction will last nor a way to control the extent of tightening.
Performing exercises designed to strengthen pubococcygeal muscles, such as the
exercises
developed by Dr. Arnold Kegel of the University of California, is a doctor
recommended way to
exercise the vaginal muscles to tighten the vagina. For those who find it
difficult to identify these
muscles, biofeedback systems can be useful. These muscles can also be
exercised using various
vaginal exercise devices (U.S. Pat. No. 4,241,912 to Mercer et al. (1980),
U.S. Pat. No. 4,048,985 to
Sasse (1977), U.S. Pat. No. 4,895,363 to Plevnik et al. (1990), U.S. Pat. No.
5,256,123 to Reinbolt
(1993), to name a few). One disadvantage to these exercise methods is that it
takes a long time, an
average of 6 to 12 weeks, to see results, so one must be dedicated to maintain
the muscle
development program long enough for it to be of benefit. In addition, like any
muscle, if the muscles
are not continually worked, the pubococcygeal muscles will lose their
strength. Another disadvantage
is that to be of benefit during sexual intercourse, the female must
consciously flex her interior
muscles, thus taking away from her ability to relax and enjoy the act of
intercourse itself.
Electrotherapy of the vagina such as described in U.S. Pat. No. 3,640,284 to
De Langis (1972),
reproduces the physical and chemical phenomenon connected with normal muscular
work. A small
electronic probe is placed in the vagina and painless, low frequency
electrical currents cause
contractions of the vaginal muscles. Alternatively, the vaginal muscles can be
exercised with
attractive magnets such as described in U.S. Pat. No. 6,672,996 to Ross et al.
(2004). Unfortunately,
both of these methods are expensive and not viable for use in home conditions.
Vaginoplasty is a surgical procedure that helps tighten the vaginal muscles as
well as the
supporting tissues of the vaginal wall. Any excess vaginal mucosal tissue is
excised or removed with a
laser. The result is an immediate decrease in the size of vaginal muscles.
This is a costly procedure,
and has the following risks: problems with anesthesia, bleeding, hematoma,
infection with swelling,
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soreness and tenderness and post operative scarring. There is also the risk of
losing sensitivity due to
complications within the vaginal wall area and muscles.
Canadian Patent Application Number 2,673,567, by Mark, filed June 26, 2008,
describes a sexual
aid device which is inserted within a human female's vagina to provide a
sensation of increased
fullness to the female and a sensation of increased tightness and friction to
a penis of a human male
during sexual intercourse.
Deficiencies in Mark's sexual aid device and method are as follows:
(a) Mark's device is not engineered or designed for shielding the posterior
vaginal wall, the
introitus or the perineum while in use (use here comprises sitting, walking,
normal daily
activities and coitus). Mark's device neglects to cover a broad area
comprising the posterior
vaginal wall, the introitus and the perineum, thus exposing women, who
experience
hypersensitivity, to frictional contact in these areas. The posterior vaginal
wall, the introitus
and the perineum are often the location of hypersensitivity, including but not
limited to, tears,
occlusions, sutures, scars, sores, warts and herpes. Furthermore, Mark's
device guarantees
frictional contact along the full extent of the posterior vaginal wall, the
introitus and the
perineum when the device is attached to a penis via a ring or a condom. This
frictional contact
further irritates hypersensitive areas.
(b) Mark's device is not engineered or designed to be used outside of coitus.
His device is not
designed to be retained exclusively by the vagina at all times. Within the
vagina, Mark's device
is designed with only one mechanism of retention, a bulbous head. When a
female uses
Mark's device, and is in a standing position, the device is susceptible to
movement by gravity
such that the bulbous head drops towards the vaginal entrance. Mark's
embodiment that has
an anal penetrator serves as a second means of retention, however, this form
of retention
complicates daily restroom activities and may otherwise not be suitable for
all day wear.
Mark's device is not designed to be comfortably worn all day and all night.
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(c) Mark's device does not have shape geometry that allows the device to seat
itself when being
inserted into the vagina and to remain seated during use without penetrating
the anus. When
Mark's device is positioned in a single orifice, his device is not self-
locating, is not self-retaining,
does not remain in a user defined position and does not resist rotation.
Mark's device does not
have a mechanism to unfurl which serves to pull the device into the vagina
when it passes the
vaginal entrance muscles nor does his device have shape and geometry to
prevent the device
from wholly entering the vagina while being inserted and while in use. Mark's
device does not
have features which retain the device in a user-defined, predetermined
position inside and
outside of the vagina.
(d) Mark's device is not engineered or designed to be exclusively retained by
the vagina to enable
a female to use a blood collection device, such as a tampon. Furthermore, his
device does not
function to support a method of transdermal medication delivery.
(e) Mark's device is not designed to accommodate insertable and removable
electronic devices.
His device has built-in electronic devices which increase the manufacturing
costs, limit the end
users' options, and render Mark's device not easily recyclable.
(f) Mark's embodiments that are manufactured from a single material stretch
the introitus
muscles when the device is inserted. To minimize stretching of the introitus
muscles, Mark
does have an embodiment that is cylindrically collapsible for insertion into
the vagina,
however, this embodiment requires at least two different types of materials
and a more
complex manufacturing process which complicates recycling of the device.
Mark's device does
not take advantage of an engineered shape that is simple to manufacture and
that can be
rolled by hand into a narrow cylinder for easy insertion into the vagina
without stretching the
introitus muscles.
Therefore, there is a need for some women for a non-surgical, cost-effective
solution to shield at
all times a sensitive area on the posterior vaginal wall, the introitus and
the perineal area, to restore
the sensation of a tightened vaginal entrance and to enable women with larger
vaginas to use a
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tampon. In this regard, the posterior vaginal wall prosthesis substantially
fulfills this need. The
posterior vaginal wall prosthesis according to the present invention
substantially departs from the
conventional concepts and designs of any prior art.
OBJECTS AND ADVANTAGES
Accordingly, several objects and advantages of the posterior vaginal wall
prosthesis are:
(a) to provide a prosthesis which is self-retaining, hands-free and ergonomic
which shields against
frictional contact on the posterior vaginal wall, the introitus and the
perineal area;
(b) to provide a prosthesis which effectively decreases the volume of the
vagina and decreases
the area of the vaginal opening, thus providing a non-surgical, cost-effective
solution to giving
a woman the sensation of a tightened vagina;
(c) to provide a prosthesis which will allow couples to achieve the desired
fit and desired
sensations during sexual intercourse, decreasing the need to look outside the
relationship for
the desired fit and sensations, thus decreasing the transmission of AIDS and
other sexually
transmitted diseases or infections;
(d) to provide a prosthesis which increases sensations for the male partner by
applying more
pressure around the penis;
(e) to provide a prosthesis which prevents tampons from falling out of larger
vaginas, thus
enabling the use of tampons;
(f) to provide a prosthesis which has design features to ensure that the
prosthesis remains in
place while the vagina is being penetrated by foreign objects;
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(g) to provide a prosthesis that rolls up into a cylindrical tube-like shape
that allows for easy
insertion into the female vagina, the vaginal entrance muscles not needing to
expand to
accommodate insertion of the prosthesis;
(h) to provide a prosthesis which naturally unfurls after insertion to provide
the necessary tension
in its unfurled state to self-retain, to self-locate and to remain in place in
the vagina;
(I) to provide a prosthesis that has a flared flattened handle that resides on
the outside of the
vaginal entrance that follows the natural contours of the perineal area
protecting this area;
(j) to provide a prosthesis that has a flared flattened handle that serves to
prevent the entire
device from entering the vagina;
(k) to provide a prosthesis which is retained simultaneously both inside and
outside of the
vagina;
(1) to provide a prosthesis which resists rotation after being inserted into
the vagina.
Further objects and advantages will become apparent from a consideration of
the ensuing
description and drawings.
DRAWINGS - Figures
FIG. 1 is an isometric view from above of the posterior vaginal wall
prosthesis with a
retention bulb in accordance with one embodiment.
FIG. 2 is an isometric view from below of the posterior vaginal wall
prosthesis of FIG. 1.
FIG. 3 is a top view of the posterior vaginal wall prosthesis of FIG. 1.
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FIG. 4 is a cross sectional view taken along line 4-4 of the posterior vaginal
wall prosthesis
of FIG. 3.
FIG. 5 is a cross sectional view taken along line 5-5 of the posterior vaginal
wall prosthesis
of FIG. 3.
FIG. 6 is a sagittal view showing the posterior vaginal wall prosthesis of
FIG. 1 in position in
the vaginal passage of a human female.
FIG. 7 is an isometric view from above of the posterior vaginal wall
prosthesis in
accordance with a second embodiment.
FIG. 8 is an isometric view from below of the posterior vaginal wall
prosthesis of FIG. 7.
FIG. 9 is a top view of the posterior vaginal wall prosthesis of FIG. 7.
FIG. 10 is a cross sectional view taken along line 10-10 of the posterior
vaginal wall
prosthesis of FIG. 9.
FIG. 11 is a cross sectional view taken along line 11-11 of the posterior
vaginal wall
prosthesis of FIG. 9.
FIG. 12 is an isometric view from above of the posterior vaginal wall
prosthesis in
accordance with a third embodiment.
FIG. 13 is an isometric view from below of the posterior vaginal wall
prosthesis of FIG. 12.
FIG. 14 is a top view of the posterior vaginal wall prosthesis of FIG. 12.
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FIG. 15 is a cross sectional view taken along line 15-15 of the posterior
vaginal wall
prosthesis of FIG. 14.
FIG. 16 is a cross sectional view taken along line 16-16 of the posterior
vaginal wall
prosthesis of FIG. 14.
DRAWINGS - Reference Numerals
100 pancake-shaped body
110 narrowed neck
120 flared flattened handle
130 mid-section bulb
140 protruding side wing
240 body retainer
250 handle retainer
260 body finger hole
270 handle finger hole
280 texture
290 recess
310 combined retainer
610 posterior vaginal wall
620 posterior fornix
630 perineum
640 introitus
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DETAILED DESCRIPTION - FIGS. 1-6 - FIRST EMBODIMENT
One embodiment of the posterior vaginal wall prosthesis which resembles a
paddle with a curved
handle is illustrated in FIGS. 1-5. This embodiment comprises a pancake-shaped
body 100, a narrowed
neck 110, a flared flattened handle 120, and a mid-section bulb 130. The
pancake-shaped body 100
includes two protruding side wings 140, 140. The narrowed neck 110 connects
the pancake-shaped
body 100 to the flared flattened handle 120 as illustrated in FIG. 1. This
embodiment comprises a
flexible, resilient, unitary structure wherein the pancake-shaped body 100 and
the flared flattened
handle 120 are disposed in divergent relation with an included angle in
between. Within this included
angle, the tear-drop shaped mid-section bulb 130 is positioned at the base of
the pancake-shaped
body 100 near the narrowed neck 110 with the largest part of the bulb placed
closest to the narrowed
neck 110 as shown in FIG. 2. The posterior vaginal wall prosthesis is sized
and configured to be placed
in a human female vagina as shown in FIG. 6 so that the end of the pancake-
shaped body 100 is
disposed towards the posterior fornix 620 of the vagina, the mid-section bulb
130 is positioned to
contact the posterior vaginal wall 610, the narrowed neck 110 is at the
introitus 640 and the flared
flattened handle 120 points towards the perineum 630. It is important to note
that the narrowed
neck 110 is crescent-shaped to allow sexual intercourse when the prosthesis is
thus positioned in a
vagina. The cross section of the narrowed neck 110 is illustrated in FIG. 5.
The preferred material for the manufacture of this embodiment is a medical-
grade silicone or an
elastomeric gel with a durometer measuring between 15-25 on the Shore 0 scale
of hardness.
Preferred elastomeric gels to be used are described in U.S. Pat. No. 5,807,360
to Shubin (1998). This
embodiment of the posterior vaginal wall prosthesis can be made with any other
material that
comprises the following characteristics. The material should be soft and
flexible and deformable by
human fingers. The material should have elastic memory to prevent permanent
deformation and
allow the prosthesis to naturally unroll after insertion into the vagina. The
material should also be
stable and capable of multiple washings without deterioration. The material
should also have the
density and tactile feel of human flesh and be capable of readily transmitting
vibrations and heat
throughout the material.
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The posterior vaginal wall prosthesis is molded using conventional liquid
injection molding
techniques and technologies.
Operation - FIGS. 1-6 - First Embodiment
Starting at one of the protruding side wings 140 and ending with the opposite
protruding side
wing 140, the pancake-shaped body 100 is rolled up with the mid-section bulb
130 on the outside.
The rolled up pancake-shaped body 100 is then inserted into the vagina until
the narrowed neck 110 is
positioned at the introitus 640 and the flared flattened handle 120 resides on
the exterior of the
vagina, adjacent the perineum 630 (see placement in human female vaginal
passage in FIG. 6). Once
inside the vaginal cavity, due to the prosthesis material's natural tendency
to return to its original
shape, the prosthesis will unroll. However, complete unfurling is not
necessary for the prosthesis to
function as intended. Slight minor displacements for comfort can be performed
by adjusting the
flared flattened handle 120. In this position, the prosthesis reduces the
volume of the internal cavity
and reduces the area of the vaginal entrance. In addition, various narrowed
neck geometrical
configurations can emulate a larger male sex organ. The mid-section bulb 130
and the shape of the
pancake-shaped body 100 act as a retention means to retain the prosthesis
within the vagina. The
shape of the flared flattened handle 120 acts as a prevention means to prevent
the flared flattened
handle 120 from entering the vagina.
To remove the prosthesis, the flared flattened handle 120 is clasped and the
prosthesis is gently
pulled out of the vagina. Due to the shape and the deformability of the
pancake-shaped body 100, the
prosthesis will naturally fold the wings 140 to allow the prosthesis to be
removed. The prosthesis can
then be cleaned and reused.
To use the posterior vaginal wall prosthesis with a tampon, the prosthesis is
placed in position as
described above and the tampon is next inserted into place following tampon
insertion instructions.
The tampon is then removed and changed as needed. The prosthesis can be
removed, washed and
reinserted as needed.
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Description - FIGS. 7-11 - Second Embodiment
Another embodiment of the posterior vaginal wall prosthesis is shown in FIGS.
7-11. The
embodiment shown in FIGS. 7-11 comprises texture 280 on the non-bulb side, a
deformable body
retainer 240 embedded in the pancake-shaped body 100, a deformable handle
retainer 250
embedded in the flared flattened handle 120, finger holes 260 and 270, and a
recess 290 in the mid-
section bulb 130. Texture 280 is provided on the pancake-shaped body 100 on
the non-bulb side and
serves to act as a further means of retention by creating a higher friction
surface. This surface texture
280 serves to enhance stimulation to the male sex organ and effectively
duplicate the texture of the
posterior vaginal wall 610. Note that localized texture 280 or texture 280 on
the entire surface of the
prosthesis aids to keep tampons in place. The deformable body retainer 240
applies continuous
pressure in an attempt to flatten out the pancake-shaped body 100 in the
vagina after insertion. The
shape of the pancake-shaped body 100, the mid-section bulb 130, the body
retainer 240, and the
texture 280 serve to hold the posterior vaginal wall prosthesis within the
vagina. The shape of the
flared flattened handle 120 and the handle retainer 250 reduce the tendency
for the prosthesis to
enter the vagina during sexual intercourse. If and/or when using lubricants,
the prosthesis may
become slippery; the body finger hole 260 and the handle finger hole 270 serve
as a means to locate
and more easily grasp the prosthesis.
The recess 290 can house a vibrating and/or pulsating device commonly known as
a "bullet"
vibrator (not shown). This comprises an electrically-driven motor with an
eccentrically-mounted load,
encapsulated in a generally cylindrical casing with a rounded tip. Such a
"bullet" may be powered and
controlled remotely and may or may not have electrical cabling, or may be
internally battery-powered.
Some versions merely vibrate; others have a range of selectable pulsating
modes. With the correct
choice of materials, the vibrations and/or pulses will be transmitted
throughout the prosthesis.
Alternatively, the recess 290 can house an electrically-powered warming
device, applied in the same
manner as is the pulsating/vibrating mechanism.
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The preferred material for the embodiment of the posterior vaginal wall
prosthesis illustrated in
FIGS. 7-11 is the same as the preferred material for the first embodiment,
with a different material
required for the body retainer 240 and the handle retainer 250.
The body retainer 240 and the handle retainer 250 are preferably constructed
from a similar
material used for the first embodiment, albeit more rigid. The preferred
material for the manufacture
of the retainers is a medical grade silicone with a durometer measurement of
between 25-75 on the
Shore A scale of hardness. The retainers can also be manufactured from any
material with
elastomeric properties that can be manually stressed to deform easily. The
material must be flexible
so that human fingers can roll the prosthesis into a tube-like shape prior to
insertion into the vagina
and yet resilient enough to flex back to, or close to, its original shape.
Other common shape memory
materials that can be used for the retainers comprise: plastics, rubbers,
nylons, and polyurethanes.
Round retainers 240 and 250 are illustrated in the embodiment of FIGS. 7-11,
however, rectangular,
triangular, or any other shape can be over-molded into the prosthesis to
facilitate the same flexural
function.
The retainers themselves can be manufactured using industry standard liquid
injection molding
technologies and techniques. However, the retainers can also be common,
standard, off the shelf,
ready-made silicone O-ring retainers as shown in the embodiment of FIGS. 7-11.
The prosthesis with retainers of FIGS. 7-11 is manufactured using conventional
liquid injection
over-molding techniques and technologies.
Operation - FIGS. 7-11 - Second Embodiment
To operate the embodiment from FIGS. 7-11, if so desired, the user first
inserts a "bullet" or a
warming device into the recess 290 of the prosthesis, securing the "bullet" or
warming device in the
recess 290 with a pressure fit. Then, the embodiment of FIGS. 7-11 is operated
in the same way as the
first embodiment of FIGS. 1-6. In addition, the user can grasp the handle
finger hole 250 of the
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posterior vaginal wall prosthesis embodiment of FIGS. 7-11 to pull the
prosthesis out of the vagina.
The body retainer 240 will deform due to its elastic nature to allow removal.
A string can also be
affixed to the handle finger hole 270 to aid in the removal of the prosthesis.
If the prosthesis slips entirely into the vagina, the handle finger hole 270
and the body finger hole
260 serve as a means to locate, grasp and remove the prosthesis. This is
especially useful if additional
lubricants are used.
Description - FIGS. 12-16 -Third Embodiment
The embodiment of FIGS. 12-16 illustrates an embodiment of the prosthesis with
a combined
retainer 310. The combined retainer 310 is a unitary retainer that combines
the body retainer 240
and the handle retainer 250 and passes through the narrowed neck 110. The
combined retainer has
the same purpose as the separate retainers, serving to unroll the prosthesis
after being rolled up and
inserted into the vagina. The combined retainer 310 also holds the pancake-
shaped body 100 in place
within the vagina and prevents the flared flattened handle 120 from entering
the vagina before,
during and after coitus.
The preferred material for the manufacture of this embodiment is the same
material as the
material described for the first embodiment shown in FIGS. 1-5. The combined
retainer 310 is made
of a similar and more rigid material to facilitate the added flexural
function. The preferred material
for the manufacture of the combined retainer 310 is that of the body retainer
240 material described
for the embodiment of FIGS. 7-11.
The combined retainer 310 is manufactured using conventional liquid injection
molding
techniques and technologies. The prosthesis with the combined retainer is
manufactured using
conventional liquid injection over-molding techniques and technologies.
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Operation -FIGS. 12-16 - Third Embodiment
The embodiment of FIGS. 12-16 is operated in the same manner as the embodiment
illustrated in
FIGS. 1-5 described above.
CONCLUSION, RAMIFICATIONS AND SCOPE
Accordingly, the reader will see that the posterior vaginal wall prosthesis
can be used to shield the
posterior vaginal wall, the introitus and the perineal area. Furthermore, the
prosthesis provides
women with a new, highly effective, economical, non-surgical means to reduce
the volume of the
vagina and decrease the area of the vaginal entrance. The prosthesis is simple
to use, is easily
adjusted for comfort and provides pleasure to both the female and the male
partner.
While the above figures and descriptions contain many specificities, the
reader should not
construe these as limitations on the scope of the invention, but merely as
exemplifications of several
preferred embodiments thereof. Various other embodiments are possible. For
example, different
flexible and resilient materials can be used for the prosthesis and retainers.
The pancake-shaped body
and flared flattened handle can be diamond-shaped, rectangular, triangular,
round or have various
other shapes. The thicknesses of the pancake-shaped body and the mid-section
bulb can be varied.
The flared flattened handle can have finger holes or not. Optionally, the
flared flattened handle may
further comprise a means of anal penetration for an added means of retention.
The narrowed neck
can have different thicknesses and can be shaped to cover more or less surface
area of the introitus
resulting in varying degrees of sensations of vaginal tightness. The mid-
section bulb can take on
different shapes and be placed higher or lower on the pancake-shaped body. The
mid-section bulb
can be eliminated. The body retainer and the handle retainer can also have
different shapes, vary in
cross-section and be made of different materials. The texture can take other
forms including dimples,
small finger-like projections, or wavy contours. The texture can be localized
or on the entire surface of
the prosthesis. Pigments, scents, anti-bacterial agents or medication can be
added to the material
that comprises the prosthesis. The prosthesis can be shaped and sized for use
in other sexually
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receptive orifices. Therefore, the reader is requested to determine the full
scope of the invention by
the appended claims and their legal equivalents, and not by the examples
given.
