U.S. patent application number 10/195776 was filed with the patent office on 2003-05-08 for vaginal-pelvic muscle exerciser and birthing trainer.
Invention is credited to Barber, Richard A., Kring, Robert S..
Application Number | 20030087734 10/195776 |
Document ID | / |
Family ID | 26891318 |
Filed Date | 2003-05-08 |
United States Patent
Application |
20030087734 |
Kind Code |
A1 |
Kring, Robert S. ; et
al. |
May 8, 2003 |
Vaginal-pelvic muscle exerciser and birthing trainer
Abstract
A device for insertion into the birth canal of a female user,
comprising an asymmetrical, inflatable, bulb defining an outer
surface, the bulb sized and shaped so as to define a crease along
at least a portion of the surface adapted to be placed in registry
with the user's urethra when the bulb is inflated, the bulb further
sized and shaped to contact the bulbocavernous facia, pubococcygeal
facia and illiococcygeal facia when inflated, and means for
inflating and deflating the bulb.
Inventors: |
Kring, Robert S.; (Longwood,
FL) ; Barber, Richard A.; (Miami, FL) |
Correspondence
Address: |
Kevin P. Crosby
Brinkley, McNerney, Morgan Solomon & Tatum, LLP
New River Center
200 East Las Olas Blvd., Suite 1900
Fort Lauderdale
FL
33301
US
|
Family ID: |
26891318 |
Appl. No.: |
10/195776 |
Filed: |
July 12, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60330922 |
Nov 2, 2001 |
|
|
|
Current U.S.
Class: |
482/112 ;
482/113 |
Current CPC
Class: |
A63B 21/0085 20130101;
A63B 23/20 20130101; A63B 2023/006 20130101 |
Class at
Publication: |
482/112 ;
482/113 |
International
Class: |
A63B 021/008 |
Claims
I claim as follows:
1. A device for assisting a user to exercise the muscles of the
vaginal region comprising: an asymmetrical, inflatable, bulb
defining an outer surface, the bulb sized and shaped so as to
define a crease along a portion of said surface adapted to be
placed in registry with the user's urethra when first bulb is
inflated, the bulb further sized and shaped to contact the
bulbocavernous facia, pubococcygeal facia and the iliococcgygeal
facia when inflated; means for inflating and deflating the bulb;
means for indicating the deflection of the bulb brought about by
the contraction of one or more muscles of the user.
2. The device of claim 1, wherein the bulb is made of a
bio-compatible material.
3. The device of claim 2, wherein the material is silicone.
4. The device of claim 1, wherein the mans for indicating is a
pressure gauge.
5. The device of claim 1, wherein the means for inflating and
deflating the bulb is a hand operated pump.
6. The device of claim 5, wherein the pump includes a flexible
bladder pneumatically connected to the bulb by a fluid-tight
tube.
7. The device of claim 1, further including a bulb insertion guide
concentrically disposed within an interior cavity of the bulb, said
guide formed of a semi-rigid plastic and adapted to communicate the
interior cavity of the bulb with the means for inflating and
deflating the bulb.
8. The device of claim 1, further including means for permitting
the user to manipulate the bulb connected to the bulb.
9. The device of claim 7, further including a means for permitting
the user to manipulate the bulb connected to the bulb.
10. The device of claim 1, further including a stop-member adapted
to abut the users mons pubis when the bulb is inserted into the
user.
11. A method for allowing a user to exercise her pubococcygeous,
illiococcygeous and bulbocavernous muscles, the device including an
asymmetrical, inflatable, bulb sized and shaped so as to define a
ventral crease adapted to be placed in registry with the user's
urethra when the bulb is inflated and further sized and shaped to
contact the bulbocavernous facia, pubococcygeal facia and the
iliococcgygeal facia when inflated; means for inflating and
deflating the first bulb; means associated with the device for
indicating the deflection of the bulb brought about by the
contraction of one or more muscles of the user, the method
comprising the steps of: deflating the bulb and inserting the bulb
into a vagina; aligning the crease with the urethra of the user;
inflating the bulb so that the exterior surface of the bulb
contacts the pubococcygeous, illiococcgygeous and bulbocavernous
facia using the means for inflating and deflating; contracting the
levator ani muscles so as to deflect the bulb inwardly, displacing
fluid within the bulb out of the bulb and into the means for
indicating.
12. A device for insertion into the birth canal of a female user,
comprising: an asymmetrical, inflatable, bulb defining an outer
surface, the bulb sized and shaped so as to define a crease along
at least a portion of said surface adapted to be placed in registry
with the users urethra when the bulb is inflated, the bulb further
sized and shaped to contact the bulbocavernous facia, pubococcygeal
facia and illiococcygeal facia when inflated; means for inflating
and deflating the bulb. The device of claim 1, wherein the bulb is
made of a bio-compatible material. The device of claim 2, wherein
the material is silicone. The device of claim 1, wherein the means
for indicating is a pressure gauge. The device of claim 1, wherein
the means for inflating and deflating the bulb is a band operated
pump. The device of claim 5, wherein the pump includes a flexible
bladder pneumatically connected to the bulb by a fluid-tight tube.
The device of claim 1, further including a bulb insertion guide
concentricalyy disposed within an interior cavity of the bulb, said
guide formed of a semi-rigid plastic and adapted to communicate the
interior cavity of the bulb with the means for inflating and
deflating the bulb. The device of claim 1, further including means
for permitting the user to manipulate the bulb connected to the
bulb. The device of claim 7, further including a means for
permitting the user to manipulate the bulb connected to the
bulb.
13. A method for allowing a user to condition her birth canal, the
device including an asymmetrical, inflatable bulb sized and shaped
so as to define a ventral crease adapted to be placed in registry
with the users urethra when the bulb is inflated; means for
inflating and deflating the bulb; the method comprising the steps
of: deflating the bulb and inserting the bulb into a vagina;
aligning the crease with the urethra of the user; inflating the
bulb so that the exterior surface of the bulb contacts the
pubococcygeous, illiococcygeous and bulbocavernous facia using the
means for inflating and deflating.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application is based on co-pending Provisional Patent
Application No. 60/330,922 Filed Nov. 2, 2001
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates generally to muscle stretching and
exercise devices. More specifically, this invention relates to
devices for, in one case prepartal stretching, strengthening, and
in a another case, postpartal various muscles in the human female,
including the pubococcygeal, iliococcgygeal, and bulbocavernous
muscles as well as generally strengthening the vaginal area.
[0004] 2. Discussion of the Related Art
[0005] One of the principle drawbacks to natural childbirth is the
damage usually caused during childbirth caused by the sudden
stretching of the vaginal canal and remaining musculature and
tissue. In many cases, episiotomies are performed, with resultant,
undesired complications.
[0006] Exercising the pelvic floor musculature in women plays an
integral role in maintaining the relative health and well being of
the woman throughout her life. In addition, pelvic muscle
dysfunction is a costly and life-altering problem. Failure to treat
this dysfunction not only impairs quality of life, but also may
lead to more costly complications including incontinence, urinary
tract infections, skin breakdown, prolonged hospital stays,
depression, and decreased sexual libido. Like the rest of the body
muscle groups, the pelvic floor and vaginal muscles need to be
exercised and trained to avoid the problems and complications so
often associated with postpartum recuperation, maturing age,
incontinence, vaginismus, and inadequate sexual gratification.
[0007] In the 1940's, Dr. Arnold Kegel did pioneering work on this
dysfunction, producing a series of exercises that bear his name.
While Kegel exercises are the time-honored approach to treating
these problems, studies have demonstrated that this technique alone
is insufficient to effect real relief. Scientific literature shows
that better results are obtained when mechanical conformation of
the exercise device to the muscles is presented to the patient.
[0008] Previous devices divide easily into a number of broad
categories. Exercise may be either passive, where the device
exercises the muscle without exertion by the user, and active,
where the user exerts force with her muscles. The term "exercise"
refers to both stretching as well as strengthening activities.
[0009] The devices used for stretching are passive. One known
device for affecting a stretching of the relevant tissue and
musculature is known as the Epi-no.RTM. offered by Tecsana of
Munich, Germany, which is comprised of a hand-held inflation
bladder connected via an air inflation line to an inflatable bulb
adapted to be inserted into the birthing canal of a pregnant woman.
The bulb is shaped in the form of a symmetrical FIG. 8. The bladder
is squeezed, which causes the bulb to inflate, increasing in
diameter causing the stretching of the birthing canal. The concept
of stretching the birthing canal is quite well established
throughout the world, ranging anywhere from manual vaginal massage
which is readily used today in the United States and elsewhere to
the more primitive application, practiced among many tribes
throughout Africa and elsewhere, of inserting progressively larger
gourds into the canal to stretch the canal prior to delivery. The
concept of employing a silicone balloon was conceived as a modern
practical approach to individual training and exercise in
preparation for childbirth. The devices intended to minimize
birthing-related complications such as perineal damage to the
mother, and to facilitate the child's passage and safe delivery,
reducing the stress and physical complications on both mother and
child, and promoting safer and healthier births, and reducing
overall medical costs and complications. However, the bulb of the
Epi-No.RTM. device does not take into account the anatomical
configuration of the muscles which delineate the birthing
canal.
[0010] Among active devices are spring resistance exercisers. In
the spring type exercisers, the user resists the force of one or
more springs. In weight training, the user resists the force of
gravity.
[0011] Both types of exercise can be static, against a constant
resistance, or progressive, against an increasing resistance.
[0012] Prior devices can also be identified by the means for
measuring the resistance. Most devices use some form of fluid
pumped into an inflatable component. The inflatable component might
utilize a substance that expands a balloon or might be comprised of
a pleated or bellows device that fills out to its maximum size but
does not expand further. The pressure in the inflatable component
may be measured by a manometer, a Bourdon tube, a d'Arsonval meter,
a digital display, light emitting diodes, a liquid crystal display,
a graphic display, or any other indicator. In most cases, the
inflatable component is inflated with air but most descriptions use
the term "fluid" which could also encompass liquids. Some
inventions specifically teach use of liquids. Existing devices
differ in the means for inflating the inflatable component. Some
use a hand pump, some use a squeeze bulb, and some use a mechanical
pump. Devices also differ with respect to the material used for the
inflatable component. Early devices were usually rubber or latex,
but it has subsequently been determined that not everyone tolerates
latex well. Recently, there has been a shift to synthetics,
especially silicone-based materials.
[0013] With the above number of possibilities for each element, the
number of permutations is, indeed, quite high. However, no example
in the art teaches the solution to the problem of discomfort,
injury, or forced micturition caused by the inflatable component
pressing against the urethra prior to the disclosed invention.
[0014] U.S. Pat. No. 1,213,005 to Pillsbury teaches a C-shaped,
rubber-pad device used in veterinary practice, primarily for mares
and cows with a postpartum dislocated uterus. The device is
inserted with an inflating pipe so that the indentation of the
C-shape fits against the distal surface of the womb of the animal.
The tube is used to inflate the device using an air supply which is
not taught. Considering that the Pillsbury patent was issued in
1917 and that it was for farm use many years before rural
electrification, it is entirely possible the user was expected to
blow into the tube. No subsequent device teaches this method of
inflation. Releasing a check valve permits the device to be
deflated for removal.
[0015] The Pillsbury device differs from the disclosed invention in
a number of ways. The Pillsbury device is made of rubber while the
disclosed device is, in a preferred embodiment, made of a
silicone-based material. The Pillsbury device is designed as a
surgery substitute until natural postpartum atrophy ensues. The
disclosed device exercises vaginal and other muscles. Pillsbury
teaches no means for inflation and is not an exercise device. The
disclosed device teaches an apparatus-type pump in the preferred
embodiment. Pillsbury teaches no means for avoiding impingement on
the urethra while the disclosed device teaches a novel shape for
avoiding this impingement. Pillsbury teaches no means for
determining the pressure to which the inflatable component is
inflated. The disclosed invention teaches a variety of means for
determining the inflation pressure.
[0016] U.S. Pat. No. 4,050,449 to Castellana et al. teaches a
device for exercising the vaginal walls. The inflatable component
in Castellana is an elongated elastomeric balloon. When flaccid,
the balloon is sufficiently rigid to be vaginally inserted without
need for any stem member. Castellana teaches a device for inflating
the balloon with a gas or liquid after the balloon is inserted.
Further, Castellana teaches a pressure-indicating gauge. The
balloon is deflated for removal.
[0017] In contradistinction to the teachings of the disclosed
invention, Castellana does not teach any indentation in the balloon
for avoiding impingement of the inflatable device on the urethra.
Castellana also teaches a device with a shoulder which the user
must hold to prevent expulsion of the balloon. The disclosed device
is held in place by its unique shape. U.S. Pat. No. 4,167,938 to
Remih teaches a complex apparatus much of which is contained in a
box or cabinet. Remih teaches a stretchable bladder inserted into
the vagina and inflated by a compressed air source which may be a
squeeze bulb. Remih also teaches a manometer coupled with a
semicircular indicator to serve as a pressure indicator. The
bladder is alternately expanded and distended to provide passive
exercise and stretching to the muscles of the user. Remih teaches
coupling the bladder around a catenoidal spool.
[0018] The teachings of Remih differ from those of the disclosed
invention in that Remih does not teach the use of an indentation to
avoid impinging on the urethra, does not teach a stretchable
bladder of any particular shape as opposed to the oviform balloon
of the disclosed invention, and the disclosed invention does not
require a manometer in a cabinet. Remih teaches passive exercise
and stretching as opposed to the active exercise without stretching
taught by the disclosed invention.
[0019] U.S. Pat. Nos. 4,653,514 and 4,768,533 to Shapiro teach a
number of devices for exercising vaginal muscles, all of which are
composed of cuffed rods onto which are attached cylindrical
inflatable covers. The teachings of Shapiro differ from those of
the disclosed invention in not teaching an oviform balloon with an
indentation to prevent impinging on the urethra.
[0020] U.S. Pat. No. 5,256,123 to Reinbolt teaches a hollow,
longitudinal member which contracts alternately about its upper and
its lower girths. The member is filled with liquid which creates a
rhythmic action to exercise the vaginal muscles. The teachings of
Reinbolt differ from those of the disclosed invention in that
Reinbolt does not teach an oviform balloon with an indentation to
avoid impinging on the urethra nor does the disclosed invention
employ liquid, nor is it made with a hollow
longitudinally-extending member. Instead, the disclosed invention
expands generally radially, except with respect to the indented
area, from the core of the inserter to come into contact with the
walls of the vagina.
[0021] U.S. Pat. No. 5,674,238 to Sample et al. teaches a device
for measuring the strength of vaginal contractions. Sample refers
to his device as a perineometer. This term was used in the early
work of Arnold Kegel, see also U.S. Pat. No. 2,541,520 to Kegel.
Sample and Kegel teach an elongated probe which is inserted into
the vagina. The teachings of Sample and Kegel differ from those of
the disclosed invention in that Sample and Kegel do not teach any
device for strengthening vaginal area muscles nor do they teach any
inflatable balloon or oviform balloon with an indentation to avoid
impinging on the urethra. Sample and Kegel teach probe-like
measurement devices.
[0022] U.S. Pat. Nos. 6,063,045 and 6,217,529 B1 to Wax et al.
teach cylindrical devices for insertion into the vagina or rectum.
The cylindrical device for insertion into the vagina as taught by
Wax is described as a deformable probe which is connected to a
pressure transducer. This pressure transducer feeds information to
a display which may indicate the pressure against the probe as any
of a number of graphic figures, including curves. The teachings of
Wax differ from those of the disclosed invention in that Wax
teaches a generally hemispherical shape and the disclosed invention
teaches an oviform shape. Wax does not disclose a crease in the
probe or a bladder with any way of avoiding impinging on the
urethra.
[0023] Further comparison of the teachings of the above-identified
prior art, other prior art, and those of the disclosed device will
reveal numerous other distinctions.
SUMMARY OF THE INVENTION
[0024] The first aspect of the invention is found in the provision
of a prepartal device for assisting an expectant mother prepare her
birth canal for the act of birthing. The device enables her to
effectively train for birth and significantly reduce second stage
labor, lower birth anxiety/stress, reduce analgesic use, shorten
the period of parturition, increase apgras, reduce the incident of
perineal tears, and increase from an overall perspective a mother's
and baby's well being. The birth canal stretching device of this
invention is comprised of a bladder or other apparatus for creating
a supply of compressed fluid, such as air, an inflatable bladder,
and a fluid-tight conduit connecting the bladder to the inflation
device. A biofeedback mechanism is employed to provide the user
with a real-time readout of the level of progress being made. The
bulb, which is adapted to be inserted into the vagina, is in the
form of an asymmetrical oviform, defining an elongated crease along
an upper surface thereof adapted to be aligned with the woman's
urethra so as to avoid, or minimize, impingement upon the urethra
upon inflation of the bulb. The bulb is preferably made of a
medical grade silicon having a wall thickness in the range of
1.0-1.1 millimeters, and having a desired maximum therapeutic
inflation diameter of 10 centimeters.
[0025] A second aspect of the invention is a postpartal pelvic
floor muscle exerciser, which is a mechanical device with a
biofeedback mechanism that is distinguished from previous attempts
to effect a cure for atrophied and/or flaccid pelvic muscles
primarily by its protection of the urethra and its unique shape
which causes it to substantially uniformly contact the relevant
muscle areas when installed. The device allows for full exercise
and use of the muscles of the pelvic floor and also provides
greater awareness and voluntary control of those muscles. The
device includes an inflatable oviform asymmetrical bulb as in the
first embodiment but having a wall thickness in the range of 0.5 to
0.6 millimeters to facilitate a more sensitive bio-connection to
the muscle tissue/facia and subsequent corresponding biofeedback
during exercise.
[0026] The pelvic floor muscle exerciser is intended to promote and
maintain pelvic floor muscle strength and elasticity during all
stages of a woman's life. The device is designed to help support
the abdominal muscle structures for prevention of complications
later in life. In order to understand the design of the device, it
is necessary to understand the basic anatomy of the perineum and
pelvic diaphragm because the device, when inflated, assumes the
shape of the pelvic floor.
[0027] The central point of the perineum lies between the
urogenital diaphragm and the anal triangle muscle group. The
central point forms a shape similar to a figure "8" around the
vagina and rectum. These muscle groups are referred to as the
levator ani complex and the bulbocavernous muscle as well as the
pubococcygeous and illiococcygeous muscles. The levator ani complex
forms a hammock-like structure supporting the pelvic viscera as
well as aiding in the constriction of the vagina during coitus,
parturition, micturition, and defecation. The device is designed to
work the full levator ani complex and not just the bulbocavernous
muscle, the muscle which surrounds the vagina.
[0028] One distinguishing aspect of this device is its
asymmetrical, oviform shape with increased compliancy to allow the
device to touch the vaginal walls laterally without exerting undue
pressure ventrally toward the urethra while concurrently permitting
appropriate dorsal expansion. The asymmetrical shape of the bulb,
as opposed to a straight cylindrical shape, causes the bulb to make
contact with all of the relevant muscle groups within the vaginal
cavity upon inflation. In this way, when the bulb is inflated, its
exterior surface will be lodged gently against the pubococcygeal,
iliococcgygeal and bulbocavernous fascia.
[0029] Regarding the embodiment of the invention referred to above
for stretching the vaginal canal of a pregnant woman in
anticipation of the rigors of child birth, it is well known that,
by preparing the birth canal by pre-stretching same while an
expectant mother is pregnant, the act of giving birth can be made
dramatically easier and quicker. One way to accomplish this is to
modify the bulb of the exercise embodiment of the instant invention
by increasing the wall thickness thereof so that it can be inflated
and thereby expanded to 10 centimeters, or more, without bursting.
The device would also need to include a means for inflating and
deflating the bulb. To operate this feature of the device, the
deflated bulb is inserted into the vagina and inflated up to the
recommended maximum amount, typically 10 centimeters, depending
upon the advice of a physician. The diametrical expansion of the
bulb can be gradually increased from a nominal amount during the
beginning of treatment to a maximum amount, depending upon the
person. Such treatment should begin approximately 3-4 weeks prior
to giving birth. The scope and purpose of this feature of the
invention is to gradually and naturally stretch the vaginal
muscles, perineum and vulva prior to birth. This enables the
mother's muscles to become more flexible and dynamic, facilitating
the birth process and shortening the recovery period after
childbirth. In addition, the device will help the mother practice
the action of "pressing" or parturition phase, to help build a more
dynamic pelvic floor or muscle group, helping to prevent
incontinence problems after delivery, and significantly reducing
the need for a perineal tear.
[0030] To use the prepartal expansion device of this invention,
once the device is inserted into the vagina and the crease oriented
upwardly to generally align with the urethra, the bulb is inflated.
It is recommended that the inflation last from 30 seconds to up to
10 minutes. In this way, the muscles, perineal area and birth canal
are gently expanded over the course of 3 to 4 weeks. While the
balloon is inflated, the woman should try to compress/contract the
relevant muscles, noting the deflection on the pressure monitor
gauge. Also, the woman should try to expel or press out the balloon
by contracting the abdominal and vaginal muscles. This will help
the mother practice the delivery phase at birth. Gradually the
inflation size of the bulb should be increased, with 10-20
centimeters being the end point target. Training should be gauged
along the 3 to 4 week scheduling to coincide with the expected
birth of the child. Training should be carried out several times
each day. Each session should be limited to no more than 10-30
minutes. Once the session is completed, the pressure within the
bulb is released by opening a relief valve associated with the
device.
[0031] An object of this invention is to provide stretching and
exercising of the musculature of the vaginal region. It is
well-known that the general physical condition of many people needs
to be improved and maintained. That need extends to many parts of
the body including, in women, the vaginal region. Lack of
appropriate muscle condition which leads to such problems as
incontinence and diminished sexual satisfaction are overcome by use
of the disclosed vaginal and pelvic muscle exerciser.
[0032] Another object of this invention is to provide a vaginal and
pelvic muscle stretching and exercise device comprised of an
oviform, inflatable, balloon which can be inserted into the
vagina.
[0033] Another object of this invention is to provide a vaginal and
pelvic muscle stretching and exercise device in which the oviform,
inflatable, balloon expands to assume generally the shape of the
vagina but which is so designed as to define a ventral crease, said
crease being so located as to avoid or limit impingement on the
user's urethra.
[0034] Another object of this invention is to provide a vaginal and
pelvic muscle stretching and exercise device constructed of a
non-irritating, hypoallergenic material which will not cause
discomfort to the user. One material that may be used is
silicone.
[0035] Another object of this invention is to provide a vaginal and
pelvic muscle stretching and exercise device which includes a pump
for inflating the oviform balloon. The pump may be operated
manually or by other means.
[0036] Another object of this invention is to provide a vaginal and
pelvic muscle stretching and exercise device which includes a
handle with a positioning indicator. This handle may be used to
allow the user to insert and properly position the crease in the
oviform balloon so that impingement on the user's urethra is
limited or avoided.
[0037] Another object of this invention is to provide a vaginal and
pelvic muscle stretching and exercise device which includes a
mechanism for inflating the oviform balloon, which mechanism may be
a mechanical or hand-operated pump and may be a apparatus-like
mechanism.
[0038] Another object of this invention is to provide a vaginal and
pelvic muscle stretching and exercise device which includes a
mechanism for inflating the oviform balloon along with a check
valve to prevent unintended release of the pressure in the balloon
and a release valve to permit release of the pressure in the
balloon when the user so desires.
[0039] Another object of this invention is to provide a vaginal and
pelvic muscle exerciser with pressure readout indications on a
gauge to provide direct, realtime bio-feedback to the user of the
progress of the exercise.
[0040] Another object of this invention is to provide a vaginal and
pelvic muscle exerciser which a user may use in the privacy of her
home or other location without need for assistance of a technician
or technical or medical person.
[0041] Another object of this invention is to provide a vaginal and
pelvic muscle exercise device whose shape and form is anatomically
similar to the actual female anatomy; uniquely designed to more
accurately and efficaciously exercise the affected muscle
structures/groups.
[0042] A major benefit of the invention lies in the fact that the
shape and form closely represent actual female vaginal anatomy, to
more efficiently and efficaciously enable muscle exercise without
distortion or unnatural representation. One key objective is to be
able to exercise diverse muscle groups, and this can only be
accomplished via biofeedback of individual muscle responses. To
accomplish this task, it is imperative that the "device" be
anatomically correct, and be sensitive to each muscle group
individually; thus requiring the device to be similar/equal to
actual female anatomy. This premise is what differentiates our
device from all of the others, and needs to be clearly and
concisely so identified and presented in order to be granted patent
status.
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] FIG. 1A is a side elevational view of the inflatable
component of the invention with the distal end of the component on
the right.
[0044] FIG. 1B is a perspective exploded view of the component
shown in FIG. 1A.
[0045] FIG. 2 is a cross-sectional front elevational view of the
inflatable component with the crease portion of the component to
the top of the figure.
[0046] FIG. 3 is a cross-sectional front elevational view of the
inflatable component inserted in the vaginal area.
[0047] FIG. 4 is a top plan view of the inflatable
component/bulb.
[0048] FIG. 5 is a cross-sectional front elevational view of the
device showing the positioning handle.
[0049] FIG. 6 is a side elevational view showing the positioning
handle.
[0050] FIG. 7 is a top plan view showing the positioning handle
with the handle shown to the top of the figure.
[0051] FIG. 8 is a front elevational view of an example of an
inflation and pressure gauge mechanism suitable for use with the
invention.
[0052] FIG. 9 is a front elevational view of an alternative example
of an inflation and pressure gauge mechanism suitable for use with
the invention.
[0053] FIG. 10 is a front elevational view of a further alternative
inflation and pressure gauge mechanism suitable for use with the
invention.
[0054] FIG. 11 is a perspective exploded view of the alternative
embodiment shown in FIG. 10 showing the gauge element removed from
the handle.
[0055] FIG. 12 is a cross-sectional side elevational view of the
embodiment shown in FIG. 10.
[0056] FIG. 13 is a bottom plan view of the handle portion of the
embodiment shown in FIG. 10.
[0057] FIG. 14 is a right side elevational view of the handle of
the embodiment shown in FIG. 10.
[0058] FIG. 15 is a side elevational, exploded view of the
embodiment shown in FIG. 10.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0059] While this specification concludes with claims defining the
features of the invention that are regarded as novel, it is
believed that the invention will be better understood from a
consideration of the following description in conjunction with the
drawing figures.
[0060] The description with respect to FIGS. 1-7 which follows is a
applicable to both the birth training device as well as the
exercise device. FIG. 1 shows the inflatable component 20 which is
preferably a semi-flexible inflatable bulb with a distal end 24 to
the right in the drawing. The figure shows that the bulb 20 has an
oviform shape with the major axis 30 horizontal in the figure and
the minor axis 40 disposed vertically. At 50 is a positioning
handle having a proximal part of the inserter at 52. Tubing 80
connects the inflatable component 110 to the inflation components
of the invention described below.
[0061] FIG. 2 shows the bulb 20 with a crease or elongated V-shaped
relief 26 at the top. This crease 26 is positioned by the handle 50
so that the bulb 20 does not impinge upon the urethra. At 110 is
the distal end of an inserter 100.
[0062] FIG. 3 shows the bulb 20 inserted in a vagina (not shown)
viewed toward the distal end 24 with the portions of the bulb 20
which contact the areas of the respective muscles of the vaginal
area identified. The portion of bulb 20 which contacts the
bulbocavernous muscle is generally indicated by reference number
25, the pubococcygeous muscle at 27, the portion of bulb 20 that
contacts the illiococcygeous muscle is shown at 28, and, the
portion of bulb 20 that contacts the urethra is shown at 330.
[0063] FIG. 4 shows the bulb 20 inserted in the vagina with the
portions of the bulb 20 which contact the areas of the respective
muscles of the vaginal area identified as in FIG. 3. The portion of
the bulb 20 which contacts the bulbocavernous is shown at 25. The
bulb 20 defines a hollow inner cavity 21 for the inserter 100.
[0064] FIGS. 5-7 show the positioning handle 50 with a raised stop
member 52 to the top, the inserter 100 to the right, and the
graspable part of the inserter 53 to the left. A pair of lateral
stop members 54, 56 may also be used.
[0065] FIG. 8 shows an apparatus used for inflating and deflating
the inflatable bulb 20. Apparatus 120 may be an openable or
completely closed inflation/deflation device. By openable is meant
a system wherein cavity 21 of bulb 20 can be filled with
pressurized fluid, such as air, by a means of a bellows or other
air pressurizing device in connection with which is used an
"openable" and closeable relief valve (not shown). By "completely
closed" is meant a system, such as that shown in FIG. 8, wherein no
relief valve is utilized and the fluid within the system used to
pressure bulb 20 does not communicate with the ambient. Although
only a closed system is shown in FIG. 8 herein, it is to be
understood that either an openable or a completely closed device
may be utilized with the invention without departing from the scope
of the invention. Devices such as the squeeze bulb 1 and a
releaseable check valve 2 disclosed in U.S. Pat. No. 4,167,938 are
considered to be within the knowledge of those skilled in the art
and can be utilized as the openable pressure and release means
contemplated by this invention.
[0066] At 122 is the fitting which connects the apparatus to tubing
80, which in turn is fluidly and sealingly connected to bulb 20 via
handle 50 and inserter 100. Inserter 100 is, preferably,
manufactured of an atraumatic semi-rigid plastic, nylon or
polyoxymethalenes which is/are bio-compatible with the human body
The end 110 of inserter 100 is open fluidly communicating with
interior 21 of bulb 20 with conduit 80 and inflation device 120. At
124 is the handle or handle of the apparatus 120. At 126 is the
shaft of the apparatus shown with the handle 124 of the apparatus
in its fully extended position. At 130 in both FIG. 8 and FIG. 9 is
a muscle deflection indicating pressure gauge, which in the
embodiment shown in FIG. 9 includes a circular needle gauge which
is a visual, and may be color-coded, indicator of the extent of the
deflection of the bulb 20 brought about by the user contracting her
muscles. In this way, direct visual feedback is given to the user.
In the embodiment shown in FIG. 8, the indicator is a linear gauge,
which may utilize numerical gradations or color gradations such as
the blue, pink, orange and red zones shown at 130. A movable
indicator (not shown) within apparatus 120 will be moved or
deflected in response to the insertion of pressure on bulb 20 by
the user. IN this way, direct, real time, visual feedback is given
to the user during use. Gradually, the degree of deflection of the
indicator will be increased as the muscles are strengthened.
Alternatively, an illuminated indicator or audio indicator, or any
other suitable construction which will occur to one of skill in the
art. Alternatively, mechanism 120 can be a simple squeeze bulb,
hand or machine operated bellows, or pressurized air source.
[0067] The user deflates the bulb 20 by withdrawing the handle 124.
In another embodiment, a pressure release valve is opened to
release any pressure remaining in the bulb 20 above atmospheric.
Once bulb 20 is deflated, the user grasps the lower part of the
inserter 50 and inserts bulb 20 by pressing the distal end of bulb
20 against and through the vulva and labia until bulb 20 is fully
inserted into the vagina.
[0068] The user then rotates bulb 20, if necessary, using the
positioning handle 50 until the stop member 52 is ventrally
positioned such that the crease 26 is positioned so that bulb 20
will not impinge on the urethra 330.
[0069] The user then inflates bulb 20 by pushing down on the handle
124 of the apparatus 120, which forces air or other fluid through
the tubing 80. The tubing connects to the proximal part 53 of the
inserter 50.
[0070] Inflation of the bulb 20 can be brought about by either
moving handle 124 to the position immediately adjacent housing 120
shown in FIG. 8, by squeezing an inflation bulb or bellows, (not
shown), or by any other means which will occur to those of skill in
the art. The bulb 20 is sized and shaped in such a way that its
exterior surface will come into contact with the interior walls of
the woman adjacent the iliococcgygeal, pubococcygeal and
bulbocavernous and other pelvic floor muscles. Once the user has
inflated bulb 20, the user may undertake whatever exercise regimen
she or her practitioner selects. In general, contraction of the
relevant muscles by the user will cause bulb 20 to deflect
inwardly, decreasing the size of cavity 21 and forcing air or other
fluid back through tube 80 into apparatus 120. This, in turn,
raises the pressure within apparatus 120 causing the gauge 140 or
other visual or audio indicator to be deflected in correspondence
with the magnitude of deflection of bulb 20 by the user. In this
way, the user gets direct feedback as to the strength of her
musculature, and progress can be closely monitored. Upon
completion, the user deflates bulb 20 by withdrawing handle 124 or
releasing the fluid which has filled bulb 20 through any other
means such as a manual release valve. Then, by drawing upon the
inserter 50, withdraws bulb 20.
[0071] In one embodiment, bulb 20 is deflated by the user extending
handle 124 until it is positioned as shown in phantom in FIG. 8. In
other embodiments, the user simply opens a relief valve to release
the pressure. Inflation/measurement apparatus 120 can be calibrated
in such a way that only one stroke of handle 124 is required to
fully inflate or fully deflate bulb 20.
[0072] In some embodiments, the inflatable component 20 may have a
disposable cover. This cover assists in maintaining hygiene. In
other embodiments, the inflatable component 20 is sanitized after
each use, thus readying it for the next use.
[0073] The recommended wall thickness of the bulb for the exercise
embodiment is between 0.5 and 0.7 millimeters. The inflation range
for the utilization of the device as an exerciser is 2psi-6psi.
Consequently, gauge 130 in FIG. 8 or gauge 140 of FIG. 9 should be
calibrated accordingly. To utilize the invention as a stretching
device, the wall thickness of bulb 20 should be increased. The
recommended wall thickness for a silicone bulb is between 0.9 and
1.1 millimeters when used as a stretching device. The recommenced
inflation pressure range for use of the device as a stretching aid
is between 10 psi-30 psi, although other values may be appropriate
under appropriate circumstances.
[0074] It is to be understood that the gauges 130 and 140 need not
necessarily utilize numerals. All that is called for is to have a
visual or other indication of the magnitude of deflection of the
bulb 20 to provide bio-feedback in real time.
[0075] The bulb makes direct contact with the pubococcygeous muscle
frontal/anterior and lateral of the vagina. The bulb also makes
direct contact with the illiococcygeous muscle s posterior and
ventrally of the vagina. A low inflation pressure (2-3 psi) allows
for sensitive deflection of the wall of bulb 20 when muscle
contraction takes place. The bio-feedback via the pressure gauge
allows the patient to confirm the muscle contractions and better
determine muscular isolation and exercise. The effective exercise
and control of the pubococcygeous, bulbocavernous and
illiococcygeous muscles brought about by this device enhance sexual
gratification and reduce incidence of incontinence by strengthening
the overall pelvic floor muscles. The egg shape of the bulb 20 and
the exercise activity performed in connection herewith pull the
rectum and perineal body (muscles) toward the pubic bones and
squeeze the lumina of the pelvic viscera closed, coming in contact
with key muscle groups of the pelvis, the coccygeus muscles
(pubococcygeous and illiococcygeous), and furthermore promoting a
vaginal integrity via exercising the bulbocavernous muscle as well.
This total exercise function, with bio-feedback, permits the
patient (user) to actively exercise these muscle groups and promote
muscular elasticity and contractivity resulting in long term
benefits. The unique asymmetrical egg or ovoid shape of the bulb 20
simulates the actual anatomy facilitating direct muscle contact and
bio-feedback. When inflated the bulb 20 will expand laterally,
ventrally and dorsally, maximizing the muscular contact for
bio-feedback, yet preventing ventral pressure on the urethra, and
forming a compliant interface with muscles lateral/ventral and
dorsal. The unique shape of the bulb 20 also assists users in
overcoming vaginismus, the voluntary or involuntary contraction of
muscles around the opening of the vagina, by exercising or
controlling muscle contractions and relaxation, evidenced by the
bio-feedback gauge. The foregoing helps overcome fear, pain, trauma
or negative attitudes about sexual intercourse. The bulb
anatomically conforms to the female pelvic anatomy when inflated
and used as an exercise device. The bulb is designed to work the
full levator ani complex muscle group. The lower half of the bulb
20 will stimulate the illiococcgygeous muscle while the middle to
upper part will stimulate the pubococcygeal muscle and the
bulbocavernous muscle.
[0076] FIGS. 10 through 15 show an alternative embodiment 200 of
this invention which is comprised of a handle 210 to which is
removably connected a feed back indicator 220. A pump bladder 225
foldable communicates with bulb 20 (not shown) via conduit 80 as
herein before described.
[0077] This embodiment is directed to an ambidextrous hand-held
apparatus. The ambidextrousness is obtained by placing gauge
housing 205 upon extension 230 of hand-held 210 in a direction in
which the face 207 of gauge 205 faces the user. Thus, it can be
seen that when a right-handed user grasps handle 210 by placing
bulb 225 against the palm and the fingers against finger cutouts
211, gauge dial face 207 will face the user. Conversely, a
left-handed user will reverse the position of gauge 205 with
respect to that shown in FIG. 10 (FIG. 10 being the orientation
which a right-handed user would use). One embodiment of removable
attachment of gauge 205 to handle 210 is a dowel-and-groove
arrangement in which elongated cylindrical element 231 connected to
the bottom of gauge hosing 205 is adapted to the slidably removably
disposed within the correspondingly shaped slot 232 of handle
extension 230. A spring biased lock mechanism 234, or any other
suitable mechanism, may be employed to retain gauge housing 205 in
connection with handle extension 230. The housing 205, bladder 225,
fluid passage conduit 234, element 231 and release valve 237 are
all integrally connected in fluid tight relation such that all of
these parts can be removed as one unit, reversed and replaced on
handle 210 so that gauge 207 will be facing in the opposite
direction. An O-ring 228 or other means for sealing can be used to
render the connection between passageway 234 and chamber A fluid
tight. O-ring 228 is placed into annular O-ring band 268 when
conduit 234 is abutted against shoulder 266. The interior of
inflation bladder 225 is fluidly communicated both with the
interior of tubing 80 (and consequently with the interior 21 of
bulb 20), using fluid outlet nipple 239, as well as with the gauge
mechanism within housing 205 via fluid passage conduit 234. A
pressure release valve, such as needle valve 237, may be utilized
to deflate bulb 20 when desired.
[0078] It is to be appreciated that any suitable pressure indicator
may be employed as an alternative to gauge and dial 207, such as
the linear gauge shown in FIG. 8, the radial gauge shown in FIG. 9,
or any other audio or visual device which will serve the purpose of
informing the user of a degree of inflation of bulb 20 and, for the
exercise version of the device, if the level of muscle contraction
occurring.
[0079] Various modifications and alterations of this invention will
become apparent to those skilled in the art without departing from
the scope and spirit of this invention, and it is understood that
this invention is not limited to the illustrative embodiments set
forth hereinbefore.
* * * * *