Note: Descriptions are shown in the official language in which they were submitted.
WO 99/26699 PCT/CA97/00872
PSRINBOMETER FOR DONESTIC USE
IN PRBVENTION OF URINARY INCONTINffiNCE
FIELD OF THE INVENTION
This invention relates to a novel perineometer
for domestic use. More particularly, this invention
pertains to a novel perineometer which can be used by a
woman at home or in a non-medical environment for treatment
and rehabilitation of pelvic floor muscles by pelvic muscle
exercises (PME). The benefits include improved vaginal
tone after childbirth, maintenance of sexual health, and
prevention of some forms of urinary incontinence, specifi-
cally stress incontinence.
BACKGROUND OF THE INVENTION
Urinary incontinence is a major health problem
that affects 50 to 70 percent of the institutionalized
female elderly and up to 30 percent of all older female
adults. The most common form is stress urinary inconti-
nence. Stress urinary incontinence results from a sudden
rise in bladder pressure that exceeds urethral resistance.
This rise occurs under conditions such as coughing, sneez-
ing or lifting. Appropriate pelvic muscle exercises have
been found to strengthen the skeletal muscles, which
increases the capacity of these muscles to exert pressure
against the urethra, and thus reduce or eliminate urinary
incontinence.
It has been estimated that one million Canadians,
from all age groups, suffer from urinary incontinence and
only one in five seek medical help. Because of this, the
sale of adult diapers has ballooned into a multibillion-
dollar industry in North America, with advertisements
running on prime time television. Yet in most cases,
urinary incontinence can be either cured or significantly
improved. (Dr. Gary Naglie, a specialist in geriatric
medicine at the Toronto Hospital, Toronto, Ontario, claims
there are a variety of different treatments, including
CA 02311246 2000-05-19
CA 02311246 2005-06-20
2
pelvic exercises, medication and surgery.) It is widely
recognized among obstetricians and gynecologists that three
treatments exist for urinary incontinence, including pelvic
exercises, medication and surgery.
The number of people afflicted with incontinence is
bound to swell with North America's aging population. But it
can also strike those in middle age, particularly women whose
pelvic muscles have been stretched by childbirth. Hormonal
changes accompanying menopause can exacerbate the problem.
Indeed, incontinence might well become the next big health
concern for many baby boomers.
There are three general categories of urinary
incontinence - stress, urge and overflow. Each has a variety
of causes and treatments. Learning techniques for better
bladder control, or cutting back on caffeine, a bladder
irritant, might be all that some patients require.
Certain drugs used to relax an overly sensitive
bladder, which can be the underlying cause of urge
incontinence, may cause unwanted side effects, including dry
mouth, blurry vision, constipation and mental confusion. At
the Toronto Hospital, Dr. Sidney Radomski said he and Dr.
Naglie have found evidence that Nimodipine*, a drug used to
treat stroke patients, may relax the bladder without the
unwanted side effects of other medications.
Surgery is another form of treatment for stress
incontinence. Surgeons can now repair a sagging bladder by
inserting miniaturized viewing equipment and surgical instru-
ments through a few small incisions in the abdomen. Sometimes
leaky bladders can be corrected with artificial sphincters or
collagen injections. As a general rule, surgery should be
avoided if other treatments are effective.
*trademark
CA 02311246 2005-06-20
3
Arnold H. Kegel was among the first to document the
positive effects of isometric exercises on the pelvic floor
musculature. (Kegel, A.H. (1948) Progressive Resistance
Exercise in the Functional Restoration of the Perineal Muscles.
Am. J. Obst & Gynec, 56:238-248. Kegal, A.H. (1952)
Physiologic Therapy of Urinary Stress Incontinence. Monograph
on Surgery. Publisher: Williams and Wilkins, Baltimore, USA,
pp 120-129). Kegel recommended the use of perineometers for
biofeedback in pelvic muscle training.
Simultaneous exercise with biofeedback has been
proven successful and corroborated by several investigators. A
large variety of perineometer units is available for clinical
and physician office use. They generally use an intravaginal
balloon to record vaginal pressure. Some form of visual or
auditory feedback is displayed to the patient. This type of
device is simple to use and is relatively inexpensive. A
disadvantage is that careful training is required. Even so, the
exercises may be performed improperly notwithstanding careful
training. Patients who increase their intraabdominal pressure
will also elevate their vaginal pressure. This falsely
indicates the same measurable outcome as on isolated pelvic
contraction. Thus, patients under professional care using
perineometers must receive proper instructions and be evaluated
professionally from time to time to ensure that their efforts
result in a properly performed, isolated pelvic contraction.
Arnold H. Kegel, in his article entitled
"Progressive Resistance Exercise in the Functional Restoration
of the Perineal Muscles", which appeared in the American
Journal of Obstetrics and Gynecology, Vol. 56, 1948, disclosed
the first design of perineometer. A pneumatic apparatus was
devised specifically for the exercise of birth canal muscles,
with measurement of each muscular contraction visible to the
patient. A chart was provided to keep a record of the
accomplishment of each exercise period and serve as a progress
guide for both patient and physician. The apparatus consists of
a simple, balanced resistance pneumatic vaginal chamber
CA 02311246 2005-06-20
4
operating at atmospheric pressure and connected by means of
rubber tubing with a manometer calibrated from 0 to 100 mm. of
mercury. In construction, the vaginal chamber is an anode-
processed rubber cot of specified consistency, lightly
stretched over a rigid slender core with a flange at each end.
An air vent in the core connects the pneumatic chamber with
the tubing and manometer. The base of the chamber is fitted
with a round, semirigid rubber shield 8 cm. in diameter, which
limits placement in the vagina and permits pivoting into
position.
Two laboratory procedures have been developed for
the evaluation and treatment of pelvic muscle functions.
(Burgio, K.L., Robinson, J.C. & Engel, T. (1986) The Role of
Feedback in Kegel Exercise Training for Stress Urinary
Incontinence. Am. J. Obst & Gynec. 154: (1) 58-64) Burgio et
al. inserted catheters into the bladder to monitor bladder
pressure and pressure balloons into the anus and rectum to
monitor anal sphincter and intra-abdominal pressure,
respectively. Discrimination training involved contracting the
anal sphincter, which is commonly innervated with the
pubococcygeal and other pelvic muscles, while relaxing the
abdominal musculature.
A second medical laboratory and physician procedure
was used by Dougherty and her colleagues. (Dougherty, M.C.,
Abrams, K.R., McKey P.L. (1886) An Instrument to Assess the
Dynamic Characteristics of the Circumvaginal Musculature.
Nursing Research. 35: (4) 202-206). They developed a fluid-
filled intravaginal balloon device that is inserted vaginally
and is connected to a pressure transducer that provides digital
and visual information regarding pelvic muscle contractions.
They also developed a pressure-sensitive posterior balloon
device that is placed in the fornix of the vagina as a measure
of intra-abdominal pressures. (Dougherty, M.C., Bishop, K.R.,
Abrams, R.M., Batich, C.D., Gimotty, P.A. (1989). The Effect
of Exercise on the Circumvaginal Muscles in Postpartum Women.
J. Nurse Midwifery. 34:(1) 8-14). Using these devices, and in
company of physicians, or other qualified therapists, patients
CA 02311246 2005-06-20
learn to discriminate and enhance pelvic muscle contractions
while minimizing counterproductive abdominal contractions.
While Dougherty et al. have reported excellent
5 reliability and reproducibility using their technique, it is
unlikely that their technique will find widespread clinical use
because of its time-consuming nature. However, the technique
may be an important adjunct in clinical trials using pelvic
floor exercise as therapy for urinary incontinence.
H. Gordon et al., in an article entitled "Perineal
Muscle Function after Childbirth", (Gordon, H., Logue, M.
(1985). The Lancet, July 20, 123-125), disclose a perineometer
for measuring perineal muscle function in European women one
year after childbirth. The perineometer consists of a thin
rubber condom, without a terminal teat, which can be inserted
vaginally and inflated until the subject is just conscious of
pressure. This gives the zero reading and subsequent pressure
change is recorded on the gauge in cm water. The condom can be
changed for each subject so the need for sterilization is
eliminated, and it can be inflated to take account of
variations in vaginal capacity. Once initial pressure causes
the condom to inflate, the subsequent pressure needed to
increase the volume is very small.
A number of patents issued over the years disclose
various designs of instruments for use in measuring perineal
muscle strength, among other things.
U.S. Patent No. Issue Date
3,752,150 August 14, 1973
4,048,985 September 20, 1977
4,050,449 September 27, 1977
4,167,938 September 18, 1979
4,216,783 August 12, 1980
4,241,912 December 30, 1980
4,476,880 October 16, 1984
4,515,167 May 7, 1985
4,574,791 May 11, 1986
- 6 -
4,653,514 March 31, 1987
4,666,447 May 19, 1987
4,768,522 September 6, 1988
5,213,557 May 25, 1993
5,256,123 October 26, 1993
Foreian Patents
GB 1,532,360 November 15, 1978
GB 2,187,959 September 23, 1987
AU 92/17,573 December 30, 1992
DE 4,134,116 April 22, 1993
DE 41 39 241 A(J. Steindorf), 27 May 1993, dis-
closes a biofeedback apparatus which includes a micropro-
cessor (4) which is programmed by a physician (see Figure
1). The disclosed apparatus includes a probe (1) which is
primarily intended for use in the anus (see Figures 10 and
11, particularly). The probe (1) for anal use, as shown in
Figures 10 and 11, includes an inflatable bulb (61) . By
means of this apparatus, contraction exercises can be
prescribed by a physician for an incontinent patient,
coupled with a rectal expansion stimuli, whereby the
patient after each observed rectal expansion, makes a
contraction of the anal sphincter muscle and the pelvic
floor muscles. Figures 9 and 9A illustrate a profile of a
variable length probe sensor (1) which has an onion shape
sensing head (11), connected to a slender cylindrical
sensing stem (12), a depth limiting plate (13) and a handle
(14). This embodiment is theoretically adaptable for
vaginal use, but the stem (12) is not inflatable. The
device, by having at one end a bulb (11) of a diameter that
is larger than the stem (12), and a covering mesh (63),
coupled with the inability to inflate the stem (12), makes
the device unsuitable for enabling a patient to conduct
active vaginal muscle strenthening exercises at home by
squeezing the stem (12).
~~O~p ~EET
CA 02311246 2000-05-19
r I
- 7 -
EP-A-0 219 410 (M. Duhem), 22 April 1987, dis-
closes a monomeric catheter which is used, inter alia, for
active retraining of patients with urinary or anal inconti-
nence. The catheter is designed for insertion into a body
cavity (anus or vagina) and works in conjunction with the
sphincteral muscle mass which is to be retrained. The
catheter consists of a tubular, oblong elastically
stretchable canula (7) framed by rigid anterior (4) and
posterior (5) distal parts. The canula (7) contains an
orifice connecting with an outside medium which is
intended, when the catheter is functionally placed in the
cavity, to be filled with a fluid which serves as a pres-
sure transmission medium. The catheter includes a pair of
electrodes (26) which are attached to the outside surface
of the canula (7). The electrodes (26) contract and when
charged with electricity cause the anal or vaginal muscles
to contract. An apparatus (12) capable of monitoring
electrical discharges from the two electrodes (26) is
associated with the canula (7). A combination of the two
electrodes (26) and pressurized fluid in the catheter (7)
generates an outgoing signal. This signal is processed
through electrical means and the magnitude of the signal is
displayed on an illuminated display pad (26) corresponding
respectively to pre-established pressure thresholds. The
catheter (7) with the pair of electrodes (26), in combina-
tion with fluid filling the catheter, provides the correct
electrical contact required for the transmission of elec-
trical impulses to the adjacent muscular mass of the
cavity, the electrical impulses being provided by electri-
cal stimulation equipment.
The apparatus does not include a built-in train-
ing/exercise program. Moreover, the vaginal probe (cathe-
ter) requires exact positioning in the vagina because both
ends are rigid and only the middle portion can expand under
air pressure to provide resistance to the vaginal muscles.
The Duhem apparatus also is deficient for home use because
AMENDED SHEET
CA 02311246 2000-05-19
- 8 -
air pressure application is difficult, and potentially
dangerous. No safety valve is provided. Also, it is
debatable whether the syringe proposed as a source of
compressed air can maintain 273 mm Hg pressure, as quoted.
A further shortcoming is that Duhem states a
procedure where a given volume of air is placed in the
bulb, and the resultant pressure is zeroed. It is not
practical for the patient to begin exercises or tests at
the same pressure. Large differences in response will
result.
SUMMARY OF THE INVENTION
The subject invention relates to a novel perine-
ometer and accessories which can be used at home without
direct medical supervision.
A perineometer for enabling a user to conduct
pelvic muscle exercises under domestic conditions compris-
ing: (a) means for manually generating pneumatic pressure
in the perineometer; (b) flexible pneumatically inflatable
hollow vaginal bulb means connected pneumatically to the
manual pneumatic pressure means (a); and (c) instrument
support means connected to the pneumatic pressure means (a)
or vaginal bulb means (b), said support means supporting a
microprocessing means, a source of direct electrical
current, an electronic pneumatic pressure sensing means, a
manually manipulatable memory switch electronically con-
nected to the microprocessing means, an on-off switching
means controlling the transmission of electrical current
from the electricity storage means and the microprocessing
means, and an electronic digital readout display enabling
a domestic user of the perineometer to monitor the perform-
ance of the perineometer.
AiVIENDED SHEET
CA 02311246 2000-05-19
- 9 -
A pressure preset relief valve and a manual air
release means can be connected between the manual pneumatic
pressure means and the inflatable vaginal bulb. The
perineometer can include a program in the microprocessing
means to record past history of pneumatic pressure in the
perineometer and enable the microprocessing means to
instruct the perineometer to return to the historical
pneumatic pressure level.
The microprocessing means can include programming
to enable the domestic user to monitor time, fluctuations
in pneumatic pressure in the vaginal bulb due to vaginal
contractions of the domestic user, and count the frequency
and number of the vaginal contractions.
The vaginal bulb can include a resilient, hollow
inflatable shell, an internal elongated hollow air tube
means to enable air to be pumped into or exhausted from the
interior of the resilient vaginal bulb. The shell of the
vaginal bulb can have a sheath-like construction, with an
opening at one end, the end of the shell opposite the
opening having in the interior thereof a resilient means
for enabling the end of the vaginal bulb to retain its
shape and a resilient means at the interior region of the
shell proximate the opening, and a seal sealing the opening
of the vaginal bulb to the pneumatic pressure means. The
vaginal bulb of the perineometer means can include a
flexible cover which removably fits over the shell.
The perineometer can include a flange mounted
around the periphery of the air inlet and outlet tube means
adjacent the shell. The support means of the perineometer
can include manual button means for enabling the domestic
user to increase or decrease the pneumatic pressure in the
perineometer. An electric air pump which can be electri-
cally connected to the microprocessing means and enable the
microprocessing means to activate the electric air pump and
CA 02311246 2000-05-19 AMENDED SHGtj
- 10 -
pressurize the perineometer to a pressure programmed into
the microprocessing means.
The perineometer can include a plurality of
programmed pressure and relaxation sequences, which can be
displayed on an electronic display panel, and can enable
the domestic user to follow a program of perineal muscle
contraction and rehabilitation procedures.
The perineometer can include an adjustable belt
which can be worn by the domestic user to hold the vaginal
bulb means in place in the vagina of the domestic user.
The belt can include an adjustable length waist strap, an
adjustable length crotch strap, and a means in the crotch
strap for holding the vaginal bulb means. The waist strap
and the crotch strap can have fasteners thereon which
enable an end of the waist strap to be releasably secured
to a body portion of the waist strap and an end of the
crotch strap to be releasably secured to a body portion of
the crotch strap.
In another aspect, the invention is directed to
a method of conducting pelvic muscle exercises in a woman
under domestic conditions using a perineometer comprising:
(a) inserting flexible pneumatically inflatable hollow
vaginal bulb means into the vagina of the woman; (b)
manually generating pneumatic pressure in the bulb; (c)
activating a microprocessing means, an electronic pneumatic
pressure sensing means, a manually manipulatable memory
switch electronically connected to the microprocessing
means, and an electronic digital readout display with a
source of direct electrical current, and enabling the woman
to monitor the performance of pelvic muscle contractions on
the perineometer.
The method can include connecting a high pressure
preset relief valve means and a manual air release means
AMENDED sHEET
CA 02311246 2000-05-19
- 11 -
between the manual pneumatic pressure means and the inflat-
able vaginal bulb to prevent pressure in the bulb exceeding
a prescribed level.
The microprocessing means can be programmed with
a record of past history of pneumatic pressure in the
perineometer to enable the microprocessing means to command
the perineometer to return to the historical pneumatic
pressure level. The microprocessing means can also be pro-
grammed to enable the woman to monitor time, fluctuations
in pneumatic pressure in the vaginal bulb due to vaginal
contractions of the woman, and to count the frequency and
number of the vaginal contractions.
Manual button means can be included for enabling
the woman to activate an electric air pump which can be
electrically connected to the microprocessing means, the
electric air pump pressurizing the perineometer to a
pressure programmed into the microprocessing means. A
plurality of pressure and relaxation sequences can be
programmed into the microprocessor and displayed on an
electronic display panel which enables the woman to follow
a program of perineal muscle contraction and rehabilitation
procedures.
BRIEF DESCRIPTION OF THE DRAWINGS
In drawings which illustrate specific embodiments
of the invention, but which should not be construed as
restricting the spirit or scope of the invention in any
way:
Figure 1 illustrates a schematic view of a manual
perineometer according to the invention.
Figure 2 illustrates a detail schematic view of
a perineometer exercise bulb according to the invention.
CA 02311246 2000-05-19 AMENDED $HEET
- 12
Figure 3 illustrates a schematic view of elec-
tronics and instrumentation associated with the manual
perineometer according to the invention.
Figure 4 illustrates a schematic view of an
automatic perineometer according to the invention.
Figure 5 illustrates a detailed schematic view of
the electronics and instrumentation of the automatic
perineometer according to the invention.
Figure 6 illustrates a front view of perineometer
support belt according to the invention.
Figure 7 illustrates a perspective view of an
assembled perineometer support belt according to the
invention.
DETAILED DESCRIPTION OF SPECIFIC
EMBODIMENTS OF THE INVENTION
Referring to the drawings, Figure 1 illustrates
a schematic view of a manual perineometer according to the
invention. This is suitable for home use. Written
instructions, as well as optional video and CD-Rom instruc-
tions, are provided. Supervision by a physician, physio-
therapist or other health care provider is not required.
The perineometer is sold in association with detailed
instructions for use, as well as an optional instruction
video. The perineometer 2, of the invention, is con-
structed of a resilient inflatable vaginal bulb 4 which'has
a flange 6 which impinges against the vulva area of the
woman. The flange 6 prevents the patient over-inserting
the bulb 4 into the vagina and potentially causing physical
injury. A manually pressable air bulb 10, with a high
pressure relief valve and manual air release 12, is con-
nected to the vaginal bulb 4 by first air tube 14. A
AiVlEtVD~D SI ic~T
CA 02311246 2000-05-19
- 13 -
digital readout board is connected to the air bulb 10 by
second air tube 16.
= The valved air bulb 10 and the relief valve 12
are important because they prevent any possibility of over-
inflation of the vaginal bulb 4, which a home use patient
might do without professional supervision, even though full
instructions are provided. This overinflation is especial-
ly possible with a patient who is commencing the program.
The readout board 8 has thereon a number of
displays and manually controllable buttons. A manual on-
off switch 30 can be manipulated by the home user to start
or stop the electronics accompanying the perineometer 2.
A manually manipulatable start-count button 42 enables the
domestic user to start an electronic count to keep track of
time in seconds and to count the number of vaginal contrac-
tions over a given time. The pressure of inflation of the
flexible vaginal bulb 4 is disclosed in pressure readout
44. A running count of time in seconds is displayed in
time display 46. The number of vaginal contractual counts
is displayed on count 48.
As an option, the pressure indicator 44 can be
programmed to monitor a prescribed inflation pressure and
if the pressure exceeds that pressure, activate relief
valve 12 until the pressure is rectified by lowering the
air pressure to less than the specified pressure.
Figure 2 illustrates a detail schematic view of
a perineometer exercise bulb 4 according to the invention.
As seen in Figure 2, the vaginal bulb 4 is sheath-like and
adapted for insertion into the vagina. It includes a semi-
firm round-end cylindrical shell 17, which is sufficiently
stiff that it will not collapse when inserted in the
vagina. It can be constructed of a suitable plastic such
as polyethylene or latex. The air impermeable, semi-
AMENDED SHEET
CA 02311246 2000-05-19
aw. ._ vv= a.a a- nva. waauv~vi -- ' - ' as ` _ V . ..V = tYf-_ _ . _ _ .blMr
Oiil_ !}VC1-- liiayfl4f.lb C # !~
- ~.4 -
flexible and inflatable sheJ.l 17 su.pports a removable
covering 18, which is preferably constructed of-or covered
with a non-allergenic material such ae silicone rubber. If
need be, a conventional latex condom can be used, if
allergies are not a problem. The she1,1. 17 is open at one
end and has extending therein an air inlet and outlet tube
20, which has a number of air ports 22 along its length.
These allow air to pass into or out of the shell 17. Air
inlet and outlet tube 20 is connected at the end oppoeite
the vaginal, bulb 4 to first air tube 14, as seen in Figure
1.
To ease insertion into the vagina by providing
support, and for comfort, the sheath-like shell 17 has at
the closed end thereof, in the interior thereof, a resil-
ient end liner 24. A corresponding resilient inside liner
26 is contained within the and of the shell 17, proximate
to the flange 6. This provides comfort in the area of the
vaginal opening and eases withdrawal from the vagina. The
covering 19 fits over the edges of flange 6, as shown at
19.
While not shown, the shell 17 and covering 18 may
be of a laminated conetruction combining both strength and
resilience, if such a design is required. It is also
important that both the shell 17 and covering 18 have
sufficient resilience that they can conform to the shape of
the vagina of the individual patient, while at the same
time, they have sufficient overall strength not to over
inflate at any one particular region. Common balloons, for
instance, have weak areas and can be made to inflate at
certain areas, while other areas remain uninflated. This
uneven inflation phenomenon is to be avoided with the bulb
4. However, the structure of the walls of the bulb 4 and
shell 17 must be sufficiently flexible to ensure that the
AMENDED SNEEt
CA 02311246 2000-05-19
- 15 -
proper pelvic floor muscles are contracted or flexed on the
bulb 4 and true consistent measurements are obtained.
The cover 18 should either be washable after
single use or be removable and replaceable on a one-time
use basis for reliability and hygienic reasons. It shoulcl
also be of a material and design that it can be readily
installed over the shell 17 and flange 6, and readily
removable when desired.
Figure 3 illustrates a schematic view of elec-
tronics and instrumentation associated with the manual
embodiment of the perineometer according to the invention.
As seen in Figure 3, the electronics and instrumentation
for the manual perineometer include a battery 28, which
typically can be a rechargeable 2 to 12V cadmium battery,
or a small large capacity long life 2V-12V lithium battery.
The electronics should be such as to require only small
voltage, for example 2 to 12 volts. Electrical low voltage
current to operate the system can be delivered on an on-off
basis via on-off switch 30, and electrical wires 32 to a
microprocessor 34. The microprocessor 34 can be a conven-
tional silicon chip type. The microprocessor 34 can be
programmed using known programming techniques with operat-
ing instructions as well as a large almost unlimited number
of alternative vaginal perineal muscle rehabilitation
exercises if desired, or prescribed by a physician. For
instance, one program can be a periodic series of five or
ten second perineal muscle contractions, interrupted on a
sequential basis by fifteen second pauses or relaxation
periods. The length of each program in seconds and minutes
can also be programmed into the microprocessor 34. Alter-
nating periods of contraction and relaxation, the frequency
thereof, and the pressure thereof, can be prescribed by a
certified gynecologist.
AMENDED SNEET
CA 02311246 2000-05-19
- 16 -
The microprocessor 34 can also be programmed
according to known techniques to record and display the
perineal muscle rehabilitation history and progress of the
domestic user. This program can be called up by manipulat-
ing memory switch 36. Program data, and history data are
displayed on digital readout 8. A pressure sensor 38,
which can be a conventional pressure transducer, with
electronic converter, measures the air pressure in tube
connection 40, which is connected to second air tube 16 as
shown in Figure 1. A pressure safety limit can be pro-
grammed into the microprocessor 34 or can be built mechan-
ically or electronically into the pressure sensor 38 or
related hardware, according to known techniques.
Figure 4 illustrates a schematic view of an
automatic perineometer 50 according to the invention. The
automatic perineometer 50 as illustrated in Figure 4 does
not require a manually manipulatable valved air bulb 10
(see Figure 1), and is entirely electronically controlled.
A vaginal bulb 52, which is constructed in a manner similar
to the bulb 4 that is illustrated and discussed in associ-
ation with Figure 2, and a protective flange 54, are
connected via air tube 55 to electronic readout board 56.
The digital readout board 56 carries a trio of manually
manipulatable pressure set buttons 58. These buttons 58
can be used to increase, decrease or maintain specific air
pressures according to the needs of the domestic user or as
prescribed by a qualified physician. A maximum pressure
limit can also be programmed into the microprocessor for
the safety of the home user.
The digital display board 56 also carries a
manually manipulatable memory button 60, which the domestic
user can press to cause the electronic memory of the
microprocessor to automatically set air pressure in the
perineometer 50 to the same level as used by the domestic
user during a previous exercise. A manually operated
AINIEhDEJ SHEET
CA 02311246 2000-05-19
- 17 -
program button 62 can be used by the domestic user to call
up any one of a number of preset programs that can be
programmed in the microprocessor. A manually manipulatable
on-off switch 64 can be pressed by the user to either turn
on or off the perineometer 50. The readout board 56 also
carries a digital display panel which displays pneumatic
pressure 66, time 68, measured in seconds, and vaginal
contraction counts 70. Thus the domestic user can keep
track of vaginal muscle contractions and relaxation fre-
quencies and intervals, as well as pressure. The program,
pressure, time intervals, and the like can be changed at
any time.
Figure 5 illustrates a detailed schematic view of
the electronics and instrumentation of the automatic
perineometer 50 according to the invention. As can be seen
in Figure 5, the electronics for the automatic perineometer
50 include as a power source an electric battery 72, which
can typically be a long life lithium battery or a
rechargeable nickel cadmium battery of 2 to 12 volts.
Alternatively, the automatic perineometer can be powered
from a conventional 110 volt alternating current source,
with an adapter and transformer to reduce and alter the
electrical current to 6-12 volt direct current. The
electrical power supply to the perineometer from battery 72
is controlled via an on-off switch button 64 and flows
along wiring 74 to a microprocessor 75. The microprocessor
75 can be programmed using accepted program techniques with
a wide variety of selectable exercise and rehabilitation
programs according to the needs of the domestic user and as
prescribed by a qualified physician. Memory switch button
60, which causes the microprocessor 75 to command that the
perineometer return to a previous pneumatic pressure
reading or give a previous history, is manually
manipulatable by the domestic user.
WOJBct~ SHEET
CA 02311246 2000-05-19
CA 02311246 2005-06-20
18
Program switch button 62 can be used by the
domestic user to call up any one of a number of alternative
exercise and rehabilitation programs programmed into the
microprocessor. These are displayed on readout 66. If the
domestic user wants to change the pneumatic pressure, the user
can change the pneumatic pressure accordingly by manipulating
manual pressure set buttons 58. A pressure sensor 76, is
connected to the microprocessor 75 by line 81. By reading
electronic information data from the electronic pressure sensor
76, the microprocessor 75 is able to control the pressure in
the automatic perineometer to a previous level, maintain the
pressure, or decrease or increase the pressure according to
commands from the pressure set buttons 58.
A preset safety valve 78, which is positioned
between the air pump 80 and the pressure sensor 76, ensures
that pneumatic pressures in the automatic perineometer 50 do
not exceed predetermined safety levels. An electrically
activated bellows type air pump 80 is used to generate
pneumatic pressure in the automatic perineometer 50. As seen in
Figure 5, the bellows air pump 80 is controlled via line 84 by
microprocessor 75. Tube connection 82 connects the bellows air
pump 80, and other components, to air tubing 55, which is
illustrated in Figure 4.
Dougherty et al., in their article entitled "Graded
Pelvic Muscle Exercise", (Dougerty, M.C., Bishof, K.R., Mooney,
R., Gimitty, P.A., Williams, B. (1993) Graded Pelvic Muscle
Exercise. Effect on Stress Urinary Incontenence. Journal of
Reproductive Medicine. 38:(9) 684-691), utilized a pelvic
muscle exercise regimen for determining the effect of such
pelvic muscle exercise on stress urinary incontinence in
middleaged and elderly women. The protocol required 16 weeks of
exercise, 3 times per week, for a total of 48 sessions. The
PME protocol began with sessions requiring 15 repetitions of a
10-second contraction of the pelvic muscles. Ten repetitions
were added every four weeks, resulting in
- 19 -
45 repetitions during level 4. An audio cassette tape
recording was provided to guide PME sessions.
A similar regimen, as well as other programs, can
be programmed into either the microprocessor 34 of the
manually inflated perineometer 2 or the microprocessor 75
of the automatic perineometer 50.
G. Elia et al., in an article entitled "Pelvic
Muscle Exercises: When Do They Work?", which appeared in
the American Journal of Obstetrics and Gynecology, Vol. 81,
No. 2, February 1993, reported the results of an evaluation
conducted during a 6 month period on 36 women with genuine
stress urinary incontinence. Following clinical and
urodynamic evaluation, the patients started an active Kegel
exercise program. This was conducted by an experienced
physiotherapist who enhanced motivation by working on
positive clinical feedback and establishing a friendly
sympathetic relationship. The subjects were instructed to
contract the pelvic muscles for 10 seconds and then relax
for 10 seconds. Each cycle of contraction/relaxation was
performed in three different positions. The patients first
would contract the pelvic muscles standing on their toes,
then standing with legs abducted and elbows resting on a
chair, and last in the supinedecubitus position with both
hands on the abdomen to feel for abdominal muscle contrac-
tions. The purpose of the different positions was to avoid
Valsalva-type efforts. The adequacy of the contractions
was checked on a one-to-one basis by pelvic examination and
perineometer; when the patients were considered ready, they
started the group sessions. The training program lasted
for 3 months and consisted of biweekly group classes for
1.5 hours during the first 6 weeks, and weekly sessions
thereafter. The women were asked to perform the exercises
at home for 15 minutes four times a day.
AMENDED SHEET
CA 02311246 2000-05-19
- 20 -
Similar programs, as well as other programs, can
be programmed into either the microprocessor 34 of the
manually inflated perineometer 2 or the microprocessor 75
of the automatic perineometer 50.
L.J. McIntosh, et al., in an article entitled
"Pelvic Floor Rehabilitation in the Treatment of Inconti-
nence", reported in the Journal of Reproductive Medicine,
Vol. 38, No. 9, September 1993, reported the results and
effectiveness of a pelvic floor rehabilitation program
conducted on a sample of 48 women with follow-up interviews
from 6 to 3 years. Patients with genuine stress urinary
incontinence, unstable bladder and mixed incontinence
showed 66%, 33% and 50% respective improvement rate. The
strength and duration of pelvic muscle contraction was
significantly greater between the first and last visits of
all patients, regardless of the subjective improvement.
The study concluded that a pelvic floor rehabilitation
program was an effective alternative to surgical interven-
tion in reducing the frequency of urinary leakage.
The original perineometer proponent, Arnold H.
Kegel, in an article entitled "Early Genital Relaxation,
new technic of diagnosis and nonsurgical treatment", which
appeared in the November 1956, Vol. 8, No. 5, issue of the
American Journal of Obstetrics and Gynecology, recommended
the following regimen for using his original design of
perineometer. After 5 to 10 correct contractions, the
perineometer is inserted, and both physician and patient
watch the manometer to note the results of her efforts.
The woman may practise exercises with the apparatus in the
office for 5 or 10 minutes, during which time the physician
has an opportunity to check whether she is contracting
according to instructions. The patient is instructed to
exercise with the aid of the perineometer for 20 minutes,
2 or 3 times a day. Since frequent repetition is essential
for establishing a new reflex pattern, the woman is advised
Afl1ENDED SHEET
CA 02311246 2000-05-19
,... _ . .=.... , ...v~.._..ar.~.,a_._ . . - . _ a,-_ ~ ~ v . ~,v=uu_. _ . . _
_vvr, voi_ _rvot-= rra7 ot~ Gu.y~'tYOa1F I
- 21
-
to contract the same muscles without the apparatus 5 to 10
times every half hour, throughout the day, and to interrupt
the flow of urine several times whenever she voids. Any of
these programs, and others as well, can be programmed into
the microprocessor 75 of the automatic perineometer 50 or
the microprocessor 34 of the.manual perineometer 2.
Some patients using the manual perineometer 2 may find they have some
difficulty holding the perineometer 2
in position in the vagina while they are operating the air
bulb 10 and doing their exercises. zn this case, the
patient may wish to use a belt to hold the perineometer in
position.
Figure 6 illustrates a front view of perineometer
support belt according to the invention. Figure 7 illus-
trates a perspective view of an assembled perineotneter
support belt according to the invention. Ae eeen in Figure
6, the belt 86 is constructed of a flexible waist strap 88
and a right angle crotch strap 90. A conventional hook and
pile (velcro'''"i) fastener 94 is located at the free end of
the crotch strap 90 and enables the user to secure the
strap 90 snugly about her crotch. A slit 96 is located in
the mid-region of the crotch strap 90. This slit 96 fits
over the f lange 6 of the bulb 4 and holds the flange 6
against the surface area of the vagina and the bulb 4
inside the vag4.na. The slit 96 also enables the tube 20 of
the bulb 4 to protrude through the slit 96 and be connected
to the perineometer. The belt 86 can be constructed of any
number of flexible materials euch as leather, plastic or
cloth. Nylon woven belting that does not stretch is
especially suitable.
AMNOEp SNEET
CA 02311246 2000-05-19
