Note: Descriptions are shown in the official language in which they were submitted.
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Improvements In and Relating to Pelvic Floor Muscle
Exercisers & Indicators
Field of the Invention
This invention relates to pelvic floor muscle (PFM)
exercisers, indicators and kits thereof. Readers will be
aware that such PFM exercisers have been used in the past
to cure or at least ameliorate feminine stress
to incontinence, which is commonly attributable to the
weakening of the PFMs with age, as a result of childbirth
or as women approach the menopause.
Although the following description concentrates on the use
of devices for increasing strength of pelvic floor muscles
with regard to preventing, curing or alleviating stress
incontinence, it is to be mentioned that the devices
hereinafter described may equally be used to test or
improve the strength of pelvic floor muscles for other
2o reasons. Indeed, as has been proposed in the past, PFM
exercisers can provide a valuable means of assessing the
strength of PFMs as women have heretofore been generally
unable to provide suitable information, often being
unaware of their existence. Accordingly, the invention is
not to be considered limited to its particular application
in the field of curing, alleviating or preventing stress
incontinence, although it is this application to which the
invention is ideally suited.
CONFIRMATION COPY
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Background to the Invention
PFM exercisers and their use in preventing or at least
reducing stress incontinence are both well known and
adequately described in the prior art.
For instance, GB-A-2058571 describes a device for
exercising the perineal muscles which comprises a shaft
having a tapered portion with an enlarged spherical end
l0 for insertion into the vagina and includes provision for
suspending various different weights from the alternate
end of the shaft.
US-A-4241912 describes an isometric vaginal exercise
device comprising a rounded shaft having a flange at one
end thereof. The shaft has a concave portion adjacent the
flange, wherein the diameter of the concave portion
decreases to a minimum value and then increases to a
maximum value with increasing distance from the flange.
The concave portion allows gripping of the device by
perivaginal muscles of the user. The flange is oval to
permit accommodation between the legs of the user. A
handle is attached to the flange end of the device.
EP-A-0198641 describes a set of parts for testing and/or
strengthening the PFMs of wearers wherein the set
comprises a number of substantially identically shaped and
sized devices all adapted for insertion into the vagina
beyond the PFMs so that the PFMs are automatically caused
to contract in an attempt to prevent the device from
falling from the vagina. It is the nature of such muscles
to automatically contract which can be used to strengthen
same beneficially to aid or cure incontinence, as
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substantially the same muscle set can be used to control
or prevent the flow of urine from the bladder. This
patent further describes that within the set of devices,
each device is of a different weight so that the PFMs can
be strengthened progressively by using progressively
heavier weights, each device having a lower conical
portion which is in use supported by the PFMs and an upper
rounded tip. The patent also mentions that the devices
may be formed from a combination of materials such as for
1o example a plastic such as polymethylmethacrylate or nylon
and a metal such as brass or steel provided with a
suitable physiologically acceptable coating, such as may
be deposited by chromium plating.
This device is useful as far as satisfactorily determining
the heaviest weight supportable by the PFMs of a wearer is
concerned, but the devices are not generally intended for
domestic use nor for use in the treatment of stress
incontinence. In the form described in the patent, the
above devices would meet with significant resistance from
and limited market acceptance by the female public on
account of the clinical nature of each of the devices and
the lack of facility for changing the particular weight of
one of the devices.
EP-A-392854 describes a PFM exerciser consisting of a
casing having two parts which can be sealingly connected
together to define a cavity in which one or more
differently shaped weights can be provided to increase or
decrease the overall weight of the PFM exerciser as
required. Moreover, the patent mentions that the device
is less expensive than existing products such as those
described above because only a single device is proved for
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insertion, and furthermore only the casing need be of a
physiologically acceptable material. In this manner,
although the casings can of course be sterilised and re-
used. Also, an appropriate set of weights can also be
provided depending on the extent to which the PFM are
required to be strengthened.
Although the above device is useful and has been widely
accepted in the market place, it is unnecessarily fiddly
l0 to configure as both the casing and the weights tend to be
small and may therefore pose difficulties as far as
assembly is concerned for less dexterous people.
There is also some suggestion of multi-part PFM exercisers
coming apart or breaking in a woman's vagina.
A user can often find it difficult to locate and contract
her PFMs. PFM exercisers can be inserted past the PFMs so
it does little good. Further, even when correctly
inserted many women are not consciously aware of their
PFMs and how to work them.
The design of PFM exercisers is in general dictated by the
following important factors. Firstly the device must be
of a suitable shape and size for insertion into the
vagina. This effectively limits the maximum diameter and
its shape which is best described as being conical at one
end, cylindrical through the middle and having a
hemispherical other end. Secondly, the weight of the
exerciser must be capable of being altered to suit
particular conditions or to provide more or less strenuous
exercise of the PFMs.
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A further design criteria of PFM exercisers which has not
been as intensively assessed as those mentioned above is
the physiological aspect of the device. It will be
appreciated that there is resistance among women to use a
5 PFM exerciser which although fully sterilised, has been
prior used. Additionally, the types of material used in
the past for such plastics have typically been plastics
which although capable of being sterilised safely are hard
and inflexible and thus aesthetically unappealing.
l0
Users are often also reluctant to use exercisers that
require repeated cleaning for fear of infection and
because of the time consuming nature of such a task.
It is an aim of the preferred embodiments of this
invention to provide an improved PFM exerciser.
Suxtmnary of the Invention
According to the present invention in a first aspect,
there is provided a PFM exerciser kit comprising a first
PFM exerciser and a second PFM exerciser, each PFM
exerciser comprising a head for insertion into a user's
vagina and a tail extending from the head, the first PFM
exerciser being heavier than the second PFM exerciser and
the first PFM exerciser having a smaller head than the
second PFM exerciser and/or a more gradually tapered
region from the head to the tail.
Suitably, a PFM exerciser kit according to claim 1, in
which the kit comprises a third PFM exerciser, which third
PFM exerciser has a head fox insertion into a user's
vagina and a tail extending from the head, and which is
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heavier than the first PFM exerciser and has a smaller
head than the first PFM exerciser and/or a more gradually
tapered region from the head to the tail.
Suitably, the different exerciser weights are
differentiated by different visual markings.
Suitably, between the head and the distil end of each tail
there is provided a stop indicator for indicating to a
user the amount of insertion of the exerciser required.
Suitably, the stop indicator comprises a change in the
diameter of each tail.
Suitably, each stop indicator comprises a bulge in the
tail.
Suitably, each stop indicator is annular about the tail.
According to the present invention in a second aspect,
there is provided a kit comprising a PFM exerciser and a
physiologically acceptable sheath in which the PFM
exerciser can be inserted for insertion into a user's
vagina.
Suitably, the sheath is provided in an infection resistant
packaging.
Suitably, the sheath comprises a condom.
According to the present invention in a third aspect,
there is provided a PFM exerciser comprising a head for
insertion into a user's vagina and a tail extending from
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the head, the tail being formed from at least in part from
a flexible material, and means for adjusting the angle of
the tail for providing a self-supporting bend in the tail
of the PFM exerciser.
Suitably, a tail angle adjuster comprises a jig into which
the tail is inserted.
Suitably, the jig is a curved receptacle for the tail.
Suitably, the jig is generally U-shaped in cross-section.
Suitably, a flexible shape-retaining material can be
provided at a bend region of the tail.
Suitably, the material is embedded in the tail.
Suitably, the tail is substantially self supporting.
Suitably, the tail is flexible along its entire length.
Suitably, the PFM exerciser comprises a rubber or plastics
physiologically acceptable outer layer.
Suitably, a weight is embedded inside the PFM exerciser.
Suitably, a plurality of weights are distributed about the
head or entire exerciser.
According to the present invention in a fourth aspect,
there is provided a method of use of a PFM exerciser the
method comprising the steps of arranging a physiologically
acceptable sheath at least partly about a PFM exerciser
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and inserting the sheath covered PFM exerciser into a
user's vagina.
Suitably, the PFM exerciser and sheath are a kit according
to the second aspect of the present invention.
Suitably, the sheath is discarded after use.
Suitably, the method comprises the steps of using the tail
angle adjusting means to adjust the tail angle and
inserting the PFM indicator into a user's vagina.
In such a configuration a user can use the PFM exerciser
to locate their pelvic floor muscles (PFMs). With the
tail in the straight configuration generally it is
difficult for a user to see the tail so when they flex
their pelvic floor muscles and therefore move the tail it
is difficult to tell whether such movement has occurred.
However with the tail in a bent configuration the tail can
be positioned such a way that a user can see the tail
moving when their PFMs are exercised.
It will be appreciated that the various aspects of the
present invention can be combined together.
Brief Description of the Drawings
The present invention will now be described, by way of
example only, with reference to the drawings that follow;
in which:
Figure 1 is a plan view of a PFM exerciser according to an
embodiment of the present invention.
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Figure 2 is a plan view of a PFM exerciser kit according
to an embodiment of the present invention.
Figure 3 is a plan view of a PFM exerciser kit according
to another embodiment of the present invention.
Figure 4 is a schematic perspective illustration of a tail
adjuster for use with a PFM exerciser.
Figure 5 is a side view of a PFM exerciser used in a PFM
indicator configuration.
Figure 6 is a schematic illustration of a PFM exerciser
according to a yet further embodiment of the present
invention.
Descri tion of the Preferred Embodiments
Referring to Figure 1 of the drawings that follow, there
is shown a PFM exerciser 2 comprising a head 4 and a tail
6. The exerciser 2 is circular symmetrical about its
longitudinal axis.
The head 4 is generally conically shaped and is suitable
for insertion into a user's vagina. The tail 6 extends
from the head 4 to a distil end 8. Intermediate the head
4 and distil end 8 is a stop indicator 10 comprising an
annular bulge in the tail. This stop indicator bulge 10
changes the diameter of the tail in such a way that it can
be felt by a user during insertion. A further bulge 12 is
provided at the distal end 8. The bulge 12 can be useful
for withdrawing the PFM exerciser 2, especially if the
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tail 6 has been lubricated; the bulge 12 provides purchase
for a user to grip the PFM exerciser 2.
The PFM exerciser 2 is formed by injection moulding a
5 SANTOPRENE (Trade Mark) thermoplastic rubber material to
encapsulate a weight (indicated by dashed lines 14)
therein. SANTOPRENE from 35 Shore A to 40 Shore D is
preferred as a physiologically acceptable material that
users find satisfactory from a tactile perspective. This
l0 ensures the tail is substantially self-supporting. A
degree of bend in the tail is permissible. This
manufacturing process creates a line 16 that provides a
convenient delineation between head 4 and tail 6.
Strictly there is no absolute distinction between the two.
It is noted that there is a narrowing tapered section 18
graduating head 4 into tail 6.
In use the head 4 of PFM exerciser 2 is manually inserted
2o into the user's vagina until the user feels the stop
indicator 10 indicating that the exerciser 2 has been
inserted sufficiently into the user's vagina. The act of
holding the exerciser in the user's vagina exercises the
PFMs.
In practice it has been found that users vary greatly in
their ability to hold a given exerciser in position.
Further, as a user progresses with the exerciser the
improvement they gain diminishes because their improved
3o PFMs are not being worked as hard with an initial
exerciser. In the prior art this has been addressed by
providing means for adjusting the weight of a single PFM
exerciser, usually by the insertion therein of weights of
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varying masses into an exerciser capable of disassembly
and re-assembly. However, it is believed that on occasion
such exercisers, especially if not done up properly, can
become disassembled in use leading to difficulties for the
user.
Accordingly, with reference to Figure 2 of the drawings
that follow there is shown a PFM exerciser kit 20
comprising a first PFM exerciser 22, a second PFM
exerciser 24 and a third PFM exerciser 26. Each PFM
exerciser 22-26 is similar to PFM exerciser 2 of Figure 1
(similar reference numerals are used for like parts)
except for variations in the shape of the head 4 and mass
of the exerciser (governed primarily by mass 14 (not shown
in Figure 2)).
Thus in Figure 2, first exerciser 22 has the largest head
4 and lowest mass (compared with second and third
exercisers 24, 26, respectively). Second exerciser 24 has
2o a head 4 size and mass intermediate first and third
exercisers 22, 26, respectively and third exerciser 26 has
a smaller head 4 and higher mass than first and second
exercisers 22, 24, respectively.
For a user, f first exerciser 22 is the easiest to hold in
place due to the larger head 4 and lower weight . Second
exerciser 24 and third exerciser 26 become progressively
harder to hold in place as their head sizes diminish and
weight increases. Thus, a user can work her way through
the PFM kit using progressively harder to hold exercisers
22, then 24 and then 26. As the weight of the PFM
exerciser increases in the kit, so the size of the head 4
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decreases. This can be done without disassembly/re-
assembly of the exerciser being required.
Although the kits shown include three exercisers, it will
be appreciated that any number of exercisers from 2
upwards can provide benefits. However three or four
exercisers in a kit is thought to be preferable for
providing a suitable range of exercisers for the majority
of users. The different weights can be differentiated by
1o visual markings, such as by being different colours eg
darker colours being heavier weights.
Referring to Figure 3 of the drawings that follow, there
is shown a PFM exerciser kit 30 comprising a first PFM
exerciser 32, a second PFM exerciser 34 and third PFM
exerciser 36. Each PFM exerciser 32, 34, 36 is similar to
that shown in Figure 1, except for variations in the shape
of the head 4, the taper 18 and the weight of the
respective exerciser, and similar reference numerals are
used for like parts.
Use of the kit 30 shown in Figure 3 is substantially
similar to that shown in Figure 2. However, the
difference in ease of holding for a user between the
exercisers 32, 34, 36 is exacerbated by their different
narrowing tapers 18 from head 4 to tail 6. First
exerciser 32 (the lightest) has an almost stepped taper 18
making it the easiest to hold. Second exerciser 34 has a
move gradual narrowing taper 18 making it harder to hold
than first exerciser 32. Third exerciser (the heaviest)
36 has a long gradual taper 18 making it harder to hold
than exercisers 32 and 34.
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Thus the difficulty of holding can be controlled through
heavier exercisers by smaller heads and/or a more
gradually tapered tail.
Another difficulty users have experienced with PFM
exercisers is the problem of locating and being able to
flex or work their PFMs. A woman is often not consciously
aware of flexing of her PFMs.
1o Referring to Figure 4 of the drawings that follow, there
is shown a PFM indicator tail angle adjuster 40 which is a
curved jig, generally U-shaped in cross-section, but so as
to receive more than half of the perimeter of the tail
jig. Thus tail angle adjuster 40 provides a channel 42
into which the tail is inserted. The tail angle adjuster
40 is a polypropylene moulding.
Referring to Figure 5 of the drawings that follow there is
shown a PFM indicator 50 that can also be used as a PFM
2o exerciser. The PFM indicator 50 is substantially the same
as the PFM exerciser 2 shown in Figure 1.
The PFM indicator 50 has had its tail 6 inserted through
into channel 42 of tail angle adjuster 40 to create the
approximate 90° angle in the tail 6. The tail angle
adjuster,40 is applied between stop indicator 10 and the
distal end 8. The SANTOPRENE (trade mark) material of the
tail 6 is substantially self supporting so with the tail
angle adjuster 40 attached, the PFM indicator 50 adopts
substantially the configuration shown in Figure 5.
For use as a PFM indicator, the device is inserted into
the user's vagina until the stop indicator 10 is reached.
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The stop indicator 10 thus can serve a double purpose of
avoiding the tail angle adjuster 40 contracting a user's
vaginal area. When the stop indicator 10 is felt the end
8 of the PFM indicator can be seen by a user because of
the angle at which the tail 6 is held. A user then
attempts various muscle contractions until the end 8 of
tail 6 is seen to twitch or move, a sign of PFM movement.
The user can then recognise the muscle
flexing/contractions required for PFM exercises ie to hold
in the various PFM exercisers described herein.
An alternative tail angle adjuster can be provided by a
flexible shape retaining strip, typically a metal strip in
a bending region of the tail 6. Such a strip can be
embedded in the tail 6 during the injection moulding
manufacturing process. A strip 52 is shown
diagrammatically in Figure 6 (see below) for ease of
reference.
Referring to Figure 6 of the drawings that follow, there
is shown a PFM exerciser 60 substantially similar to PFM
exerciser 2 of Figure 1 (similar reference numerals are
used for like parts). Additionally in Figure 6 there is
shown a physiologically acceptable sheath 62, such as a
condom into which at least the head 4 of PFM exerciser 60
is inserted for subsequent insertion into a user's vagina.
Thus the sheath 62 protects the PFM exerciser 60 from
contact with the user's vagina. After use the sheath 62
can be discarded and the PFM exerciser 60 re-used without
time-consuming cleaning. It will be appreciated that the
sheath 62 can be used with PFM indicators as well. The
sheath 62 can be provided in a foil, plastics or other
infection resistant packaging.
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The reader's attention is directed to all papers and
documents which are filed concurrently with or previous to
this specification in connection with this application and
5 which are open to public inspection with this
specification, and the contents of all such papers and
documents are incorporated herein by reference.
All of the features disclosed in this specification
to (including any accompanying claims, abstract and
drawings), and/or all of the steps of any method or
process so disclosed, may be combined in any combination,
except combinations where at least some of such features
and/or steps are mutually exclusive.
Each feature disclosed in this specification (including
any accompanying claims, abstract and drawings), may be
replaced by alternative features serving the same,
equivalent or similar purpose, unless expressly stated
otherwise. Thus, unless expressly stated otherwise, each
feature disclosed is one example only of a generic series
of equivalent or similar features.
The invention is not restricted to the details of the
foregoing embodiment(s). The invention extends to any
novel one, or any novel combination, of the features
disclosed in this specification (including any
accompanying claims, abstract and drawings), or to any
novel one, or any novel combination, of the steps of any
method or process so disclosed.
