Note: Descriptions are shown in the official language in which they were submitted.
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Title of the invention
DEVICE FOR PERINEUM REEDUCATION
Background of the invention
The present invention relates te the general field
of perineal rehabilitation devices.
More particularly, the present invention relates to
perineal rehabilitation devices comprising an endocavity
or an annuler applicator or probe locally supporting a
charging electrode and at least one stimulation electrode
either on its periphery or in its inside face, said
applicator including at least one energy storage unit
that is rechargeable via the charging electrode.
Such a probe or applicator is used, amongst other
possibilities, in particular for treating urinary
incontinence. Urinary incontinence is manifested by an
involuntary loss of urine that many people find
problematic.
There are two main types of urinary incontinence,
stress incontinence and urgent incontinence.
Stress incontinence corresponds te loss of urine as
a result of an increase in abdominal pressure on the
bladder. This increase in pressure may be due te
coughing, sneezing, laughing, or making a movement, in
particular lifting something heavy. Stress incontinence
is the most common type of incontinence and it mainly
affects women. It takes place in general when the
perineal muscles and the muscles of the floor of the
pelvis are weakened, e.g. by pregnancies, childbirth, or
the menopause.
Urgent incontinence corresponds te a sudden and
pressing need te urinate, followed by an immediate
contraction of the bladder. This contraction results in
an involuntary loss of urine. Both men and women may be
affected by this type of incontinence, in particular
among older people. One of the reasons for Such
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incontinence is a failure in the operation of the nervous
system controlling the bladder.
Mixed incontinence is a combination of stress
incontinence and of urgent incontinence.
In order to treat incontinence, it is known to make
use of electrical stimulation, e.g. using a vaginal
applicator, or in certain circumstances using surface
electrodes. The use of such electrical stimulation is
treatment that is well tolerated and that has
demonstrated good results in improving control over the
bladder and the intestines.
Thus, electrical stimulation via the pelvic nerves
is a recognized treatment alternative for urinary
incontinence. This treatment is aise proposed in order
to solve fecal incontinence due to dysfunction of the
floor of the pelvis.
When treating stress incontinence, the purpose of
electrical stimulation is to stimulate voluntary muscular
contraction and to improve the working of the muscles of
the floor of the pelvis. For urgent incontinence, the
purpose is to inhibit involuntary contractions of the
bladder by stimulating the nerves of the floor of the
pelvis. When treating mixed incontinence, particular
stimulation is used that is appropriate both for urgent
incontinence and for stress incontinence.
At present, devices exist that are suitable for
generating electrical stimulation for treating
incontinence. Some such appliances are based on using a
control platform connected by a wire to an endocavity
applicator carrying stimulation electrodes, or indeed
stimulation electrodes that are placed outside on the
skin. Such appliances are used in the offices of
physiotherapists or other health professionals. Such
devices are flot portable in any way.
Such wired devices used by physiotherapists make
many parameter modifications available. It is flot
possible to envisage the general public using such
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devices without the presence of a health professional.
Such prior art devices therefore cannot be used
individually at any location and in particular at a
user's home. Such wired appliances are also very
expensive and require special training for their use.
There also exists a wireless perineal electrical
stimulator that is rechargeable in a non-leaktight
charger box. The charger box is also used for
programming the applicator.
With that device, the applicator, or probe, is
programmed using the charger box while the probe is still
installed therein. Once the applicator is disconnected
from the charger, it is no longer possible to modify is
operation. Thus, once the applicator is programmed, it
is designed to remain inactive for three minutes, thereby
giving the user time to insert the applicator.
The device then runs the selected program. Such
automatic activation of the applicator after three
minutes of inactivity presents a certain number of
problems, or even dangers. In particular, if the
applicator is not inserted within three minutes following
its disconnection, but is inserted later, the user runs
the risk of electrocution since the program is already
running.
Furthermore, the user has no access to electrical
stimulation time ranges other than by means of the user's
own sensations. Unfortunately, it is known that useful
electrical stimulation is not necessarily perceived.
Consequently, muscle contraction exercises cannot be
performed thoroughly and reliably during electrical
stimulation.
Thus, blind operation of known portable devices
presents the advantage of enabling them to be used by the
general public and without prior knowledge. However
their operation is not without risk and does not enable
treatment to be optimized.
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Object and summary of the invention
A main object of the present invention is thus to
mitigate the drawbacks of the prior art by proposing a
perineal rehabilitation device comprising an applicator
that is either an endocavity applicator or an annular
applicator, locally supporting a charging electrode and
at least one stimulation electrode respectively on its
periphery or on its inside face, and including at least
one energy storage unit that is rechargeable via the
charging applicator, the applicator including at least
one microprocessor for executing an electrical
stimulation program, the device being characterized in
that the applicator is controlled by a control module in
the form of a remote control connected to the applicator
by a wireless connection and including a user interface
for enabling the user to input operating data for the
applicator and a control unit for controlling the
applicator by sending control signais thereto, the
applicator being suitable for receiving control signais
for modifying the intensity of stimulation while it is in
operation and for modifying its ongoing operation as a
function of such control signais.
Such a perineal rehabilitation device comprises flot
only the applicator but also a control module enabling
the intensity of stimulation to be modified while the
applicator is in operation, thereby limiting any risk of
electrocuting the user. The perineal rehabilitation
device of the invention enables the applicator to begin
operating at zero intensity, regardless of which
electrical stimulation program was selected previously.
With the invention, it is possible to make provision
for ail of the electrical stimulation programs to begin
at zero intensity. The intensity is modified solely by
the user taking action on the remote control. The use of
wireless communication between the control module and the
applicator is a characteristic that is essential for
implementing intensity modification of the stimulation.
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The use of such a wireless connection is never
mentioned in prior art devices. In prior art devices,
the applicator is programmed while it is in place in the
charger device. Thus, in prior art devices, program
5 selection is performed by communication with contact
between the applicator and the charger device.
The use of wireless communication between the
control module and the applicator is an original
characteristic of the invention. The fact that the
control module specifically enables the intensity of
stimulation to be modified remotely salves a particular
problem in the use of a wireless applicator for a
perineal rehabilitation device. The invention relates
specifically to such remote modification of the intensity
of stimulation.
With wired devices, the problem of electric shocks
does flot arise in the same way. Firstly, known wired
devices are designed to be handled by personnel having
training concerning electrical risks. Furthermore, the
structure of those devices, based on the use of multiple
electrodes, guarantees grounding, sa there is no risk of
the patient being electrocuted.
The particular intensity modification that is
provided in original manner by the invention using the
control module thus salves a particular problem that is
encountered only with wireless probes.
Thus, and advantageously, ail of the programs begin
electrical stimulation at zero intensity.
This characteristic should be understood as meaning
that programs begin at low intensity such that there is
no possibility of electrocuting the user. It is not
absolutely essentiel for the starting intensity to be
strictly zero.
According to an advantageous characteristic, the
control module includes means for indicating stimulation
operating ranges of the applicator.
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This characteristic enables the user to know when
the applicator is emitting electrical stimuli. This
enables the user to contract muscles at the same time,
thus optimizing treatment by performing exercises known
as Kegel exercises. This characteristic may be
implemented insofar as the device has an external remote
control connected to the probe or applicator via wireless
communication, and in particular when the connection is
bidirectional, thus enabling the probe to return
information about its stimulation operating ranges. In
other words, the control of the control module over the
probe of the invention can also enable this
characteristic to be implemented.
According to a particular characteristic of the
invention, the control module includes a memory for
storing time-stamped data concerning the operating
intensities and durations requested of the applicator.
In variant embodiments, it is also possible for the
applicator to include a memory.
The presence of such a memory makes it possible to
store data about the treatment ranges used by the user.
In particular, such a memory may be read by means of
dedicated software installed on a doctor's computer.
Reading this memory informs the doctor about ail of the
treatment ranges used by the patient, and also about
their characteristics.
Thus, according to a particular characteristic of
the invention, the control module includes at least one
connection port for transferring time-stamp data to a
computer.
According to a particular characteristic of the
invention, the control module includes means suitable for
sending control signais to the applicator, either
automatically or on user input, causing the applicator to
issue stimuli of increasing intensity, and the interface
includes means enabling the user to indicate the moment
when the stimuli begin to be felt.
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Advantageously, the intensity used when the user
indicates that the stimulation can be felt is stored
within the control module.
In particular when it is implemented at the
beginning of treatment, this characteristic makes it
possible to know the user's sensitivity to the stimuli.
Such data is useful in enabling the doctor to evaluate
how treatment is progressing.
This characteristic increases the intensity of the
stimuli progressively, starting from a stimulus of zero
intensity. This operating protocol makes it possible to
ensure that the patient does flot suffer any electric
shock.
The increase in the intensity of the stimuli may
take place automatically or it may be controlled by the
patient using buttons placed on the interface of the
contrai module. When the increase in intensity is
controlled by the user, the device is particularly
reliable from the point of view of absence of risk of
electrocution.
According to another particular characteristic of
the invention, the applicator, while in operation, is
suitable for taking measurements relating to the reaction
of the body.
The use of the applicator for taking measurements
relating to the reaction of the body provides feedback
concerning the user's reaction to the treatment. These
measurements may be taken by means of electrodes, or
alternatively, according to an advantageous
characteristic, by using a pressure sensor implemented on
the applicator to take measurements relating to the
reaction of the body.
In particular, such a pressure sensor makes it
possible to measure the reaction of the muscle during
electrical stimulation, in particular to measure its
contraction. The magnitude of the reaction of the muscle
to the stimuli enables the changes in user training to be
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tracked. This makes it possible to give information
about changes to the anatomical structures involved.
By way of example, the measurements relating to the
reaction of the body may be stored in a memory of the
applicator.
According to an advantageous characteristic, these
measurements may also be returned to the control module, .
providing the wireless connection is bidirectional.
Thus, when the wireless connection is bidirectional,
according to a particular characteristic of the
invention, the control module includes a "feedback" unit
for receiving measurements from the applicator, for
processing these measurements in real time, for
calculating an appropriate operating mode as a function
of the measurements, and for sending a control signal
corresponding to this mode of operation to the
applicator.
With this characteristic, it is ensured that the
applicator operates in a mode of operation that complies
with the reaction of the user's body. In particular,
this makes it possible to avoid strongly stimulating
muscles that present a reaction that has diminished as a
result of making repeated efforts, while nevertheless
continuing to apply some stimulation. This amounts to
providing the operation of the device with "biofeedback".
This particular characteristic makes it possible to
provide an appliance for training that is physical, and
flot necessarily medical. This makes it possible to
exercise muscles on fitness principles.
In addition, according to an advantageous
characteristic, the control module includes the memory
for storing the information relating to the reaction of
the body.
Such a memory serves to keep track of the reactions
of the patient's body and to provide fatigue curves for
the muscle. These reactions of the body may be used for
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adjusting subsequent operation of the applicator or
indeed for tracking variation in the muscle.
According to an advantageous characteristic of the
invention, the applicator includes an electrode for
detecting that it has been inserted or installed
correctly, which electrode is suitable for detecting
contact with the body, said electrode being suitable for
sending a signal to the microprocessor installed within
the applicator and/or the microprocessor installed within
the control module, the microprocessor being such as to
be suitable for causing stimulation to stop as soon as
the applicator is no longer in contact with the body.
This characteristic enables stimulation to be
stopped as soon as the applicator is no longer in place.
The invention also provides an endocavity applicator
locally supporting at least one charging electrode, and,
at its periphery, at least one stimulation electrode, and
at least one energy storage unit that is rechargeable via
the charging electrode, the applicator being for use with
a control module connected to the applicator by a
wireless communication connection for forming a perineal
rehabilitation device of the invention.
The invention also provides an annular applicator
locally supporting at least one charging electrode, and,
at its inside face, at least one stimulation electrode,
and at least one energy storage unit that is rechargeable
via the charging electrode, the applicator being for use
with a control module connected to the applicator by a
wireless communication connection for forming a perineal
rehabilitation device of the invention.
The invention also provides a control module
connected to an endocavity or an annular applicator of
the invention via a wireless communication connection and
including a user interface to enable the user to input
operating data for the applicator, and a control unit for
controlling the applicator by sending intensity-modifying
control signais thereto.
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Finally, the invention provides a method of
controlling an endocavity or an annular applicator, which
method is implemented in a perineal rehabilitation device
of the invention and comprises the following steps for
the control module:
= receiving applicator operation data input by the
user and relating to the intensity of stimulation; and
= sending control signais for modifying the
intensity of stimulation to the applicator;
10 and comprises the following steps for the applicator
while in operation:
- receiving control signais sent by the control
module; and
= modifying the ongoing operation.
According to an advantageous characteristic of the
invention, the method includes the following
initialization steps:
= for the control module, sending control signais to
the applicator causing it to issue stimuli of increasing
intensity, either automatically or under user control;
= for the applicator, receiving control signais and
issuing successive stimuli of increasing intensity;
= for the control module, receiving from the
interface actuated by the user a signal marking the
moment at which the stimuli begins to be felt; and
= for the control module, storing the intensity then
in use, representing the minimum intensity threshold felt
by the user.
According to a particular characteristic of the
invention, the method includes the following feedback
steps:
- for the applicator, using the electrodes while it
is in operation to take measurements relating to the
reaction of the user's body;
= for the control module, receiving measurements
from the applicator;
= processing the measurements in real time;
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= calculating an operating mode that is adapted as a
function of the measurements; and
= sending a control signal corresponding to said
mode of operation to the applicator; and
= for the applicator, modifying its ongoing
operation in accordance with the control signal.
In a preferred implementation, the various steps of
the method are determined by computer program
instructions.
Consequently, the invention also provides a computer
program including instructions for executing steps of the
method of the invention for controlling an endocavity or
an annular applicator when said program is executed by a
microprocessor computer.
The program may use any programming language, and it
may be in the form of source code, object code, or code
intermediate between source code and object code, such as
in a partially compiled form, or in any other desirable
form.
The invention also provides a storage medium
readable by a computer and having a computer program
stored thereon including instructions for executing steps
of the method of the invention for controlling an
endocavity or annular applicator.
The data medium may be any kind of entity or device
capable of storing the program. For example, the medium
may include storage means such as a read-only memory
(ROM), e.g. a compact disk (CD) or a micro-electronic
circuit ROM, or indeed magnetic storage means, e.g. a
floppy disk, a hard disk, a flash memory, etc.
Furthermore, the data medium may be a transmission
medium such as an electrical or an optical signal
suitable for being conveyed via an electrical or optical
cable, by radio, or by other means. The program of the
invention may in particular be downloaded from a network
of the Internet type.
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Alternatively, the data medium may be an integrated circuit in which
the program is incorporated, the circuit being adapted to execute or to
be used in the execution of the method in question.
The invention further provides a perineal rehabilitation device
comprising an endocavity applicator comprising: a locally supported
charging electrode, and at least one stimulation electrode on its
periphery, and including at least one energy storage unit that is
rechargeable via the charging electrode, the endocavity applicator
comprising at least one microprocessor for executing an electrical
stimulation program, wherein the device further comprising an external
control module configured as a remote control connected to the
endocavity applicator by a wireless connection, and including a user
interface for enabling a user to input operating data to the endocavity
applicator, and a control unit for controlling the endocavity applicator
by sending control signals thereto, the endocavity applicator further
comprising: an oblong portion designed for insertion into a body cavity,
said oblong portion being surrounded with annular electrodes, an
external portion constituting a handle for removing the applicator after
it has been inserted, and the oblong portion comprising a proximal
portion (P) provided with at least two said annular electrodes which are
stimulation electrodes to which sequences of electrical stimuli can be
applied, and the oblong portion comprising a distal portion (D) provided
with at least the annular electrodes for charging the applicator and
said annular electrode for detecting that the applicator has been
inserted into the body cavity, the control module capable of: selecting
a treatment program among various predetermined programs (P1-P7) to
carry out stimulations with different sequences continuously or during
different stimulation times, and selecting the duration of the
treatment, and modifying automatically or on user input an intensity of
stimulation, and indicating and storing the intensity of stimulation
when increasing intensity and that the stimuli begin to be felt by the
user, and storing in a memory time-stamped data concerning the operating
stimulation intensities and durations ordered to the applicator, and
stopping the stimulation at any moment.
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Brief description of the drawings
Other characteristics and advantages of the present invention
appear from the following description made with reference to the
accompanying drawings that show an embodiment having no limiting
character. In the figures:
- FIG. 1 shows an embodiment of a perineal rehabilitation device of
the invention;
- FIG. 2 shows a perineal rehabilitation device of the invention
during a charging stage;
- FIG. 3 shows an example of a display on the screen of the contrai
module of the invention;
- FIG. 4 is a flow chart showing the operation of the perineal
rehabilitation device of the invention;
- FIG. 5 shows a perineal rehabilitation device of the invention
while being connected to a computer;
- FIG. 6 shows an example of a display on the screen of a computer
of data stored in the control module; and
- FIG. 7 shows an example of an annular applicator of the arm band
type, of the invention.
Detailed description of an embodiment
FIG. I shows a perineal rehabilitation device of the invention.
FIG. lA shows an endocavity applicator 100 comprising an oblong portion
100a for inserting into the cavity, e.g. the vagina, and a long thin
portion 100b constituting a handle for removing the applicator after it
has been inserted. The endocavity applicator is advantageously leaktight
so as to be easy to clean.
The oblong portion 100a is provided with annular electrodes, here
five electrodes 101 to 105. Other
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electrode shapes, in particular as circular arcs could
possibly be implemented.
It should be observed at this point that any type of
wireless connection protocol may be used: preferably
Bluetooth or radiofrequency (RF), but various other
protocols could also be envisaged.
The distal portion referenced D of the oblong
portion 100a is provided with at least two electrodes 104
and 105 used for charging the applicator 100. A third
electrode 103 is advantageously added to detect that the
applicator 100 has been inserted in a body cavity, e.g.
the vagina. This avoids electric shocks.
The role of this detector electrode 103 is fo
provide a signal to a microprocessor that manages
stimulation within the applicator 100 so that the
stimulation does flot start or is stopped when the
applicator 100 is outside the body or when the applicator
100 is extracted from the vagina. In addition to this
sensor, the applicator is also advantageously such that
the electric current or intensity on ail of its channels
can be reduced to zero at any moment so as to be in a
position to remove the applicator at any moment.
The proximal portion referenced P of the oblong
portion 100a is provided with at least two stimulation
electrodes 101 and 102 to which sequences of electrical
stimuli are applied.
it should be observed at this point that the number
of stimulation electrodes could be greater.
Nevertheless, studies have shown that the ratio of the
number of electrodes to the effectiveness of stimuli is
very satisfactory when using two electrodes. The
stimulation electrodes occupy the first four centimeters
of the proximal portion P of the oblong portion 100b.
For vaginal use, it is in this location that the
stimulation is found to be the most effective, it being
understood that the device is designed for the applicator
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100 to be inserted in such a manner that the oblong
portion 100a is inserted in full.
The applicator 100 includes at least one
microprocessor for implementing the stimuli and for
managing them within the wirelessly-connected probe-
applicator.
Figure 1B shows a control module 200 in the form of
a remote control of the invention. In the embodiment
shown, the module 200 has a display screen 210 and a
certain number of control buttons, here eight buttons
referenced 201 to 208 and acting as an interface for the
user.
The control module 200 also includes a battery that
makes it independent, at least one microprocessor, and
units that are implemented in hardware or software.
It thus comprises an applicator control unit for
determining and sending control signais to the
applicator, and at least one memory for storing operating
data concerning the applicator.
A button 201 serves to switch the device on and off.
This button 201 is also used for stopping stimulation at
any moment. A button 204 enables treatment to be
started.
A button 203 serves to activate a window for
programming the duration of treatment. Typically, a
duration lying in the range 1 minute (min) to 45 min may
be selected, by using the + and - buttons 206 and 207.
A button 202 serves to activate a window for
selecting a stimulation program, e.g. from amongst seven
programs numbered Pl to P7. The program is selected by
using the + and - buttons 206 and 207.
A button 208 serves to confirm or cancel selection.
Two presses on the button 208 serve advantageously to
return to the menu that was previously selected on the
screen.
A button 205 serves to pause stimulation at any
moment. Pressing simultaneously on this button 205 and
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on the button 203 serves advantageously to cancel the
current programming.
The buttons 206 and 207 are also used during
operation of the applicator 100 in order to increase and
5 decrease the intensity of stimulation in accordance with
an essential and original characteristic of the
invention.
As described below, at least some of the buttons of
the control module 200, including the + and - buttons 206
10 and 207, may also be used for controlling a display of
data stored in the control module 200 on a computer that
is connected to the control module 200.
Figure 1C shows a preferred implementation of a
charger 300 used for an applicator 100 of the invention.
15 The charger 300 is advantageously suitable for containing
the applicator 100 for storage purposes. It contains a
recess 310 having the sanie shape as the applicator 100.
It presents contact electrodes 301 and 302 for charging
the applicator 100 as soon as it is placed in the charger
box 300. At least one third contact point 303 is used
for monitoring the level of charge of the battery.
Indicator lights 304 and 305 serve to provide
indication about the charging of the applicator 100.
Figure 2 shows the step of charging the applicator
100 inserted in the charger box 300 and of charging the
control module 200. The charger box 300 and the control
module 200 are advantageously provided with female
universal serial bus (USB) connectors, preferably of
small dimensions. These connectors are for connecting to
mains via a charger transformer 400 and two cables, each
provided with a male USB connector.
Figure 3 shows an example of a display on the screen
210. A pictogram 211 indicates that the wireless
connection with the applicator 100 is indeed established.
A pictogram 212 indicates the level of charge of the
battery of the control module 200. A pictogram 213
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indicates the level of charge of the battery of the
applicator 100.
A pictogram 214 specifies the program, in this
example "Pl", that is running or that has been selected.
A pictogram 215 indicates that a stimulation operating
range of the applicator is current. In this example, the
pictogram 215 is constituted by a circle with a disk at
its center that is lighted only when a stimulation is
running.
A display zone 216 displays a timer showing the
elapsed or remaining duration of the treatment. Where
appropriate, a pictogram 217 appears when the applicator
100 is paused.
A graduated zone 218 displays the intensity of the
current stimulation as a relative value. The display
zone 219 gives the exact value of the intensity of the
stimulation.
Figure 4 is a flow chart showing the operation of
the applicator 100 of the invention.
The control module 200 is switched on in a step El
using the button 201. The screen 210 then invites the
user to press on the button 202 in order to select a
program Pi in a step E2.
Once the button 202 has been pressed, the user can
select the program by using the buttons 206 and 207 to
select from a list of programs. The user confirms a
selection by pressing on the button 208 in a step E3.
Specifically, the user may select from among the
following programs:
The first programs Pl to P3 are dedicated to
treating stress incontinence.
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Pi Frequency Tpulse Tstim Trest Recommended
application
P1 50 hertz 200 3 seconds 6 s 30 min,
(Hz) microseconds (s) 3-5 times/week
(ps)
P2 50 Hz 200 ps 5 s 10 s 30 min,
3-5 times/week
P3 50 Hz 200 ps 10 s 20 s 30 min,
3-5 times/week
The following programs P4 to P6 are dedicated to
treating mixed incontinence.
Pi Frequency Tpulse Tstim Trest Recommended
application
P4 20 Hz 200 ps 3 s 6 s 30 min,
3-5 times/week
P5 20 Hz 200 us 5 s 10 s 30 min,
3-5 times/week
P6 20 Hz 200 ps 10 s 20 s 30 min,
3-5 times/week
Finally, the program P7 is dedicated to treating
urgent incontinence.
Pi Frequency Tpulse Tstim Trest Recommended
application
P7 10 Hz 180 ps Continuous 30 min,
2-5 times/week
Thereafter, the screen invites the user to press the
button 203 in order to select the duration of the
treatment in a step E4. Once the duration has been
selected using the buttons 206 and 207, the duration is
confirmed using the button 208 in a step E5.
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The screen 210 then invites the user to insert the
applicator 100 in a step E6. The sensor 103 then serves
to verify that the applicator 100 is indeed inserted
before beginning the treatment in a step E7.
Advantageously, the wireless connection between the
control module 200 and the applicator 100 is a
bidirectional connection, and the signal issued by the
sensor 103 is sent to the control module 200.
The screen 210 can then indicate whether or flot the
applicator 100 has been inserted correctly. When the
applicator is flot inserted correctly, the control module
200 returns to step E6. Otherwise, in a step E8, the
screen 210 invites the user to press on the key 204 in
order to start the stimulation program.
Advantageously, a sensitivity test sequence Ti to T4
then begins. This sequence constitutes an original and
advantageous characteristic of the invention. It makes
it possible flot only to begin stimulation at zero
intensity while giving a functional role to such
stimulation, but it also makes it possible to obtain
important medical data, namely the user's sensitivity
threshold. A health professional can then measure the
effectiveness of the treatment, knowing such data.
In this sequence, in a step Ti, the screen 210
invites the user to increase the intensity of stimulation
by using the + and - buttons 206 and 207. In another
possible embodiment, the increase in intensity may be
automatic. During these increments, a step T2 waits for
a signal indicating that the button 208 has been pressed.
In application of the instructions for use of the
device of the invention, once the patient feels the
electrical stimulation, she presses on the button 208.
This causes the intensity of the stimulation at that time
to be stored. The patient's sensitivity threshold
intensity is then accessible to the doctor.
The selected stimulation program is then put into
operation in a step T3. The patient then increases the
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intensity up to an intensity prescribed by the doctor,
30 milliamps (mA) in this example.
While the program is running, the center of the
pictogram 215 lights up each time a stimulation starts
and turns off when it stops. This enables the user to
know when stimulation is taking place in order to
contract muscles at the same time. In application of
Kegel exercises, such contraction encourages treatment
and restoration or reinforcement of muscular structures.
During the treatment, the intensity of the
stimulation remains accessible to the user who can modify
it as a function of her sensations or of the desired
intensity or of the intensity prescribed for the
exercise. These modifications are performed using the
buttons 206 and 207, e.g. over the range 0 mA to 60 mA.
Stimulation may be stopped at any moment, either by
pressing on the button 206 in order to decrease the
intensity, or by pressing on the pause button 205, or
indeed by pressing on the button 201, thereby stopping
stimulation completely.
According to the invention, it is also advantageous
for the software managing the operation of the applicator
100 to be such that stimulation is stopped as soon as the
sensor 103 detects that the applicator 100 is no longer
in contact with the body. This stopping of stimulation
may be under the control of the control module 200 to
which the signal issued by the sensor 103 is returned, or
indeed it may be stopped internally by the applicator
itself, with the microprocessor installed therein being
suitable for processing the data issued by the sensor 103
and for stopping stimulation.
The duration of stimulation and its intensity are
stored automatically in the memory of the control module
200.
Figure 5 shows a stage of connecting the control
module 200 to a computer 600. This connection is made
via a USB cable 500 having a male USB connector of small
CA 02735535 2016-04-18
size for connecting in the female connector 209 of the
control module, and a conventional USB connector suitable
for being connected to the computer.
The data stored in the memory of the control module
5 200 is then accessible to the computer, e.g. to the
computer of the attending doctor who prescribes the
treatment using the device of the invention.
The stored data preferably relates to the time and
date at which a program was applied, the type of program
10 that was selected, the duration of the application, a
report on whether the application ran properly
(applicator removed during treatment, incomplete
duration, in particular), mean applied intensity, and the
minimum sensitivity intensity, i.e. the result of the
15 sensitivity test performed at the beginning of
application. In the context of biofeedback applications,
it is advantageous also to store a so-called "fitness"
test showing the automatic adaptation of the intensity of
stimulation as a function of progress during the
20 application of the treatment. This provides information
about the fatigability of the muscle and about its
training.
The "viewing stored data on a computer" mode is
advantageously obtained by pressing simultaneously on the
button 202 and on the button 204 after the module 200 has
been connected to a computer 600. The display of a
particular treatment report as selected by the buttons
206 and 207 is obtained by pressing the button 204 on the
control module, for example.
It is also possible in the invention to transfer the
stored data to the computer 600. Under such
circumstances, the data is subsequently presented using a
format that is specific to software for reading that
data.
An example of such a display is shown in Figure 6.
In Figure 6A there can be seen a compact window that
CA 02735535 2016-04-18
21
shows the first une of a sub-window shown open in
Figure 6B, together with a summary of sensitivity tests.
Figure 6E shows the list of applications of
treatment performed by the patient. The summary of the
sensitivity tests in Figure 6A is in the form of a curve
of sensitivity threshold intensities detected by the
patient over the set of treatment applications listed in
Figure 6B.
Advantageously, the applicator includes a sensor
suitable for measuring the reactions of the patient's
body. In an advantageous embodiment, the sensor is a
pressure sensor suitable for measuring muscle
contraction. By way of example, the sensor may be
annular. In particular, it is possible to use a strain
gauge type sensor operating in compression.
The measurement of this contraction is then
transmitted in real time to the control module 200. The
control module has a unit, advantageously a software
unit, referred to as a feedback unit and suitable for
calculating a modification to the intensity of the
stimulation by taking account of the measured muscle
contraction.
This characteristic is original and made possible in
the invention by the combined use of a bidirectional
connection between the wireless applicator and the
control module and of a pressure sensor placed directly
on the wireless applicator.
Specifically, muscular contraction also weakens
after several successive contractions. It then becomes
pointless for the muscle that is fatigued or that is
becoming fatigued to be stimulated strongly with
electricity. This does not enable to work properly.
Thus, the invention enables the stimulation to be
adapted, while taking account of muscle fatigue, of its
magnitude, and of the rate at which it occurs.
Figure 7 shows an annular applicator 100' in the
form of an arm band. This applicator 100' is for use in
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22
perineal rehabilitation in a man. The band 100'
advantageously includes means for imparting an annular
shape to the applicator, e.g. strips 106a and 106b of
Velcro. This enables the applicator to be put into place
sa as to surround the erect penis. This applicator is
likewise advantageously leaktight.
The applicator 100' include at least one stimulation
electrode, here two electrodes 101' and 102', on its
inside face, and at least one charging electrode. Here
there are two charging electrodes 104' and 105' that are
installed on the outside face of the applicator 100'. An
electrode 103' is advantageously added to the inside face
of the band 100' in order to detect contact with the
body.
It should be observed here that the electrodes used
are flot strictly annular, but form a portion of a circle
when the applicator is in its annular configuration, in
particular when it is installed. Nevertheless, this does
flot raise any particular problem for stimulation or for
charging.
The charger box for the applicator 100' is
advantageously similar in shape to the box 300. A recess
for the applicator 100' is likewise formed inside the
box. Its shape naturally needs to be adapted to receive
the band 100' laid out flat or slightly curved.
Advantageously, closing the box presses the band 100'
between the two portions of the box sa as to ensure
contact between the charging electrodes 104' and 105' and
contactors of the same type as the contactors 301, 302,
and 304 of the box 300.
The operation and control of the applicator 100' is
similar to that described for the endocavity applicator
100. The applicator 100' is specifically advantageously
controlled with a control module similar to that used
with the endocavity applicator 100. Nevertheless, it
should be observed that different programs are
implemented since the treated dysfunctions may be
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23
different. In particular, the rehabilitation device of
the invention with an annular applicator may be used for
treating certain types of impotence.
Finally, it should be observed that various
implementations can be devised on the principles of the
invention. In particular, in the absence of a
stimulation test, ail of the programs could begin by
raising intensity progressively and with that rise being
stopped by the patient by pressing on a button of the
remote control, and with this flot involving any storage
of the corresponding stimulation intensity.
