Note: Descriptions are shown in the official language in which they were submitted.
~ XFlS
The device of this invention comprises a
substantially cylindrical elongated support
member which carries or in part defines an
inflatable cuff. The cuff extends longitu-
dinally less than one ~uarter the length ofthe support member. Means are provided for
inflating the cuff with a fluid such as a
gas, preferably air, ancl for transmitting
chanyes in pressure in the fluid within the
cuff to a display device such as a pressure
guage.
The elongated support member also carries
a flange optionally adjustable along the
length of the member. The elongated member
may also have markings or graduations so that
the flange position can be noted when the
device is first inserted~ for example by a
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medical practitioner, who will he able to locate
the cuff properly in relation to the particular
muscle whose tone is to be elevated or improved.
The user i.s then able to employ -the device without
the presence of the mcdical practitioner, having
noted the flange position, secure in the.knowledge
that the muscle oE i.nterest and not an adjacent
muscle is being monitorecl and excrcised.
Thus, for a female patient with urinary
incontinencc, the flange wi]l be placed in contact
with the external surfaces of -the labia majora
and the member adjusted to correctly locate the
cuff relative -to -the pubococcygus muscle.
Brief Description oE -the Drawings
Figure 1 illustrates one example of a device
according to the invention,
igure 2 illustrates a second example of a
device in accordance with the invention,
zo Figure 3 illustra-tes a third example of
- a device accordiny to the invention, and
Figure _ illustrates a fourth example of
a device according to the invention.
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XF15
This invention relates to a device for
assistiny a person to cxercise and stren~Jthen
and improve his or her co~trol of certain
internal muscles hereirl called sphincter-type
muscles.
In this specification, the term "sphincter-
type muscle" is used to mean any internal muscle
in the human body which plays a part in controlling
the excretory functions. ~xamples are the
anal sphincter muscle and the levatores ani
group of muscles of the pelvic floor, in
particular the pubococcygeus muscle.
Certain conflicting requirements desirably
' 15 should be met in a device of thls kind which
is intended for home use by relatively unskilled
and non-medical persons. Firstly, the device
must be stiff enough to insert to the required
distance, without it collapsing. Secondly~ the
device must be of a shape and surface texture that
is easily and comfortably inserted. Thirdly, it
must be sensitive enough to clearly register
muscle movements on.a display unit such as
a pressure guage even though only a very slight
muscle movement may have taken place.
The device of this invention by having an
inflatable cuff of limited longitudinal (i.e.,
axial) extent enables the user to monitor a
particular selected muscle. The device is very
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sensitive to slight m~scle rnovements as a result
of the relatively small internal volume of the
cuff. Thus,small changes in the volume of the
cuff register as a signi~icant propor-tional change
in the pressure reading on the guage.
According to a partic~lar embodioent of the
invention, the device inclucles a tube with one
closed and one open end forming a support rnember
and having an inflatah]e cuff near the closed
end, a second tube o~ening into the interior
of the inflatable cuff, a pressure guage attached
to the other end of the second tube, al-ld a va]ve
whereby air or gas can be allowed to enter the
second tube in order to inflate the cuff. The
tube may be made of latex rubber reinforced
over a major par-t of its length with fibre or
cord so as to impart the required stiffness to the
tube.
In a preferred version of the invention, the
inflatable cuff is formed by an internal wall
constituted by part of the support member and
an external wall which is freely stretchable.
The stretchable wall may be formed of thin
latex rubber. A conduit through which the
cuff is inflated may be formed by a second
tube or by the hollow center of the tube
constituting the support member.
In an alternative embodimen-t of the invention,
the inflatable cuff may be formed by a hollow
annular member of substantially -toroidal or
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5_
"doughnut" shape, slidable alon~ the length of
the elongated support member. The in-terior of
the cuff is then connected to a conduit so that
in:itially the cuff can he inEla-ted and thereafter
the changes in internal pressure therein produced
by spincter type muscle movement can be monitored
by a pressure gua~e~
Referring to Figure 1, a rubber -tube 10 has
reinforcement 12 over most of its length, and has
a rounded closed end 14. An inflatable cufE 16
is located near the end 14 and a second tube 18
is in communication wi-th the interior 17 of the
cuff. The tube 18 is connected to a T-piece 20
which is in turn connected to a valve 22 and a
pressure guage 24. The tube 10 has a flange 25
slidable along i-t which enables the user to
locate the device in the same position each time
it is used. As an optional refinement,
; 20 graduations 27 may be marked on the tube 10 so
that the user can note the position of the flange
25 when the cuff 16 is properly located relative
to the muscle being exercised. The~tube 10 is
preferably made of latex rubber by a dipping
process and may be amalgamated by this dipping
process with the second and thinner latex tube
18.
Referring now to Figure 2, the illustrated
device includes a first tube 40 and a floppy
cuff 42. An inflation lumen 48 is provided in
the tube 40 and opens into the interior of
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cuff 42 near i~s distal ~d. Tile lumen 4~ is
directly connected to an external thin
tube 50 incorpora-ting a test balloon 52. I'his
gives a visual indication to the user because
it is distended when the cuff is inflated. The
tube 50 leads to a valve and pressure guage
in same way as illustrated in the Figure 1
embodiment.
The tube 40 can be of rubber la-tex formed
by dippiny and including a nylon cord reinforcement
41 wound at about 24 turns per 25 rnm. oE tube
length. This reinforcement embedded in the tube
wall prevents collapse of the -tube 40 during
insertion. The floppy cuff 42 can be a thin
rubber latex wall and may have an axial length of
about 40 mm. The distal end of cuff 42 may be
spaced about 20 mm. from the closed distal end
46 of tube 40. The tube 40 may typically have
an inner diameter of about 9 mm. and an outer
diarneter of about 16 mm., and an overall length
of about 220 mm. The reinforcement 41 may extend
over the length of tube 40 except for about 10 mm.
at the distal end.
Tubes 10 and 40 can be made of materials other
than rubber. For example, synthetic polymeric
materials such as polyvinylchloride or polyurethane
with nylon or metal wire reinforcement may be
employed.
XF15
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The device illustrated in Fiyure 3 consists
of a substantially cylindrical solid rubber or
plastics mandrel 60 with a rounded end 62.
Typically, the mandrel may be about 150 mm. to
about 220 mm. in length and of a diameter oE
about 9 mm. to abou-t 12 mm~ The mandrel 60
carries a sleeve 64 of rubber or plastics
material which is s]idably mounted thereon.
Sleeve 64 has a thin flexible and e~tensible
latex rubber wall 66 fixed to i-t ln an air-tlght
fashion. Sleeve 64 and wall 66 together define
an inflatable cuff to the interior of which is
connected a thin-walled tube 68. The tube 68 may
be suitably fastened -to the mandrel 60 r in such a
way as to allow slidable movement of the cuff
along the mandrel. The tube 68 is connected to a
T-piece and valve 70 and then alternatively to a
pressure guage 72 or a manually operable inflater
bulb 74. An advantage of this construction is
that the inflatable cuff can readily be moved
along the mandrel 60, nearer to or further from
the end 62, as may be required to position it
appropriately in relation to the muscle whose
performance is to be monltored. A pressure
relief valve 76 prevents a pressure greater than
a predetermined limit being built up in the cuff
64, 66, even if the bulb 74 is continuously
operated.
X~'15
The device illustrated in Figure 4 includes
a hollow rubber latex tube 80 with a rounded end
82, its wall being of appropriate thickness
or suitably reinforced (for example as described
with reference to the device of Fi~ures 1 and 2)
to give the device a stiffness so that it can be
readily inserted witho~t discomfort and yet has
sufficient rigidity not to be deformed by -the
muscle movements being monitored. The tube 80
has a thin flexible and expansible annular rubber
la-tex wall 84, similar to the wall 16 of
Figure 1, defining with the tube 80 an inflatable
cuff 86. ~ hole 88 is provided in the wall of
the tube 80 leading into -the interior of the
annular cuff 86. The interior of the tube
~0 is connected by a line 90 to a T piece and
valve, bulb, pressure relief valve and guage
(all not shown) in the same way as illustrated
in Figure 3.
~lthough not shown in Figures 8 and ~, a
flange corresponding to the flange 25 in
Figure 1, slidable along the tube, is preferably
inclu~ed in the arr~ngements shown in ~igures 3
and 4.
Pressure guage 24 (or 72) may be mechanical,
electrical, or electronic. A muscular contraction
will show as an increase in pressure of about
1 to 8 mm. of mercury on the guage, and so will
be clearly noticeable to the patient.
XF15
_g_
The pressure ~uage may be an electFonic
pressure sensor unit capable of giving either
a numerical display of press~lre value or a
display of lights, for example of different
colors, triggered by the achievement of
certain pressure valves For example, with such
a unit it could be arrarlgcd using suitable
circuity that a given muscle contrac-tion (and
hence a given pressure) illuminates a lamp of
one color, a greatex contraction illuminates
a lamp of a second color, and a greater contraction
still illuminates a lamp of a third color. Such
a unit would preferably include a means of
controlling the sensitivity so that the particular
levels of pressure at which given lamps are
illustrated could be adjusted.
For improved sensitivity, it is preferred
- that tube 18 or tubes 50 and 48 or tube 68 be
thin. For example, the tube may have an inner
diameter of about O.S to about 1.5 mmO
The devices of this invention are employed
as follows. The device is inserted into the
body orifice to the desired depth as determined
by flange 25. The valve 22 or 70 is opened
and the cuff is inflated in any convenient
way to a light pressure, for example about 40
to 60 mm. of mercury. The valve is closed and
the patient then attempts to contract the
sphincter muscles. The resultant efforts show
clearly on t]le pressure guage.
