Method for monitoring a rehabilitation of the perineum of a person

EP4601542A1Pending Publication Date: 2025-08-20MUMMING
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Patent Information

Application Number
EP2023801819
Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-10-12
Filing Date
2023-10-11
Publication Date
2025-08-20

AI Technical Summary

Technical Problem

Current methods for monitoring perineal rehabilitation are based on subjective measurement data, which can vary significantly between individuals due to differences in finger sensation and force application, leading to inconsistent results.

Method used

A method involving an inflatable body inserted into the genital tract, where pressure and dimension measurements are taken to objectively assess perineal tonicity, allowing for personalized and comprehensive monitoring of both active and passive tonicity through automatic inflation and deflation controlled by processing means.

Benefits of technology

This approach provides objective and personalized monitoring of perineal rehabilitation progress, enabling accurate evaluation of perineal tonicity based on pressure and dimension measurements, overcoming the limitations of subjective methods.

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Abstract

The invention relates to a method for monitoring a rehabilitation of the perineum of a person. The present invention relates to a method for monitoring a rehabilitation of the perineum of a person, the method comprising the implementation, for example by processing means (80), of: a first measuring step in which an inflatable body (2) inserted at least partially into the genital tract of the person is inflated according to a predetermined pressure setpoint and a dimension of the inflatable body (2) is measured by first measuring means (6), and / or a second measuring step in which the inflatable body (2) inserted at least partially into the genital tract of the person is inflated according to a predetermined dimension setpoint and a pressure within the inflatable body (2) is measured by second measuring means (5).
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Description

Description Title of the invention: Method for monitoring the rehabilitation of a person's perineum. Technical Field

[0001] The present invention relates to a method for monitoring the progress of the effects of a person's perineal rehabilitation, as well as a system for implementing this method. Prior art

[0002] Pelvic floor rehabilitation, or perineal reeducation, is generally carried out in the case of urinary incontinence or after childbirth, for example, with a view to strengthening the perineum.

[0003] In this context, it is interesting to be able to monitor the evolution of the effects of rehabilitation on the person's perineum. Methods for monitoring such rehabilitation are known from the prior art. These methods, known as "testing," generally consist of an assessment of perineal tone. The assessment of perineal tone may include a passive assessment of perineal tone and / or an active assessment of perineal tone.

[0004] Active assessment can, for example, be performed manually by inserting two fingers into the person's genital tract and applying a contraction on both fingers by means of the perineum for as long as possible. A representative score of perineal tone can be derived from measuring the contraction duration and contraction strength reported on a scale known as the modified Oxford scale. The score generally consists of a value between zero, representative of unsatisfactory tone, and five, representative of very satisfactory tone.

[0005] Passive assessment can, for example, be performed manually by inserting two fingers into the person's genital tract, applying force to the perineum, for example, using the fingers, and analyzing the behavior of the perineum in response to this force.

[0006] A disadvantage of the tracking methods described above is that they rely on subjective measurement data. On the one hand, the feeling of contraction force may vary from person to person on the fingers, and on the other hand, the size of the fingers and the force that the fingers can apply may vary from person to person. Statement of the invention

[0007] The invention aims in particular to overcome at least in part one of these drawbacks and relates, according to a first aspect, to a method for monitoring the rehabilitation of a person's perineum, the method comprising the implementation, for example by treatment means:

[0008] of a first measuring step in which an inflatable body inserted at least partly into the genital tract of the person is inflated according to a predetermined pressure setpoint and the dimension of the inflatable body is measured by first measuring means and / or

[0009] a second measuring step in which the inflatable body inserted into the genital tract of the person is inflated according to a predetermined dimension setpoint and the pressure within the inflatable body is measured by second measuring means.

[0010] Thanks to the method according to the invention, it is possible to monitor the evolution of the effects of perineal rehabilitation from objective measurement data. Furthermore, the inflatable body makes it possible to adapt to the person's genital tract and to have personalized monitoring. In addition, the method makes it possible to monitor the evolution of the effects of perineal rehabilitation in a comprehensive manner; by an evaluation of the active tone and / or the passive tone of the person's perineum.

[0011] For example, the assessment of active tone can be carried out from the measurement of pressure within the inflatable body.

[0012] For example, passive tone assessment can be performed by measuring the inflatable body dimension. For example, the smaller the measured dimension, the more toned the perineum can be considered. Conversely, the larger the measured dimension, the less toned the perineum can be considered.

[0013] According to other characteristics of the invention, the method of the invention comprises one or more of the following optional characteristics considered alone or in all possible combinations.

[0014] The method comprises implementing the first measuring step and / or the second measuring step, by processing means.

[0015] The processing means comprise at least one processing unit configured to control at least a first part of the first measuring step and / or at least a first part of the second measuring step.

[0016] The inflation of the inflatable body of the first measuring stage is carried out automatically and / or the inflation of the inflatable body of the second measuring stage is carried out automatically.

[0017] For example, the automatic inflatable of the inflatable body is implemented by the processing means.

[0018] The method comprises an additional insertion step in which the at least one portion of an inflatable body is inserted into the genital tract of the person.

[0019] For example, during the insertion stage, only a first part of the inflatable body is inserted into a person's genital tract.

[0020] For example, the first part of the inflatable body corresponds to one half of the inflatable body.

[0021] For example, the method comprises the second measuring step, or the first measuring step and the second measuring step, the first measuring step being performed before the second measuring step.

[0022] For example, the method comprises the first measuring step and the second measuring step, the first measuring step being performed before the second measuring step.

[0023] For example, the method comprises, before the second measurement step, a step of determining the dimension setpoint by means of the dimension of the inflatable body measured during the first measurement step, the dimension setpoint being determined by the processing means.

[0024] For example, the method comprises between the first measuring step and the second measuring step, a step in which the inflatable body is, at least in part, for example in its entirety, deflated.

[0025] Deflation of the inflatable body can be implemented by the processing means.

[0026] For example, the second measurement step of the process includes:

[0027] a sub-step of inflating the inflatable body, for example automatically, according to a predetermined dimension instruction,

[0028] a sub-step of detecting the initiation of a first contraction applied to the inflatable body by the person's perineum, causing a recording of the pressure within the inflatable body, and

[0029] a sub-step of recording the pressure measured within the inflatable body.

[0030] The sub-step of recording the pressure within the inflatable body being caused by the detection of the initiation of the first contraction.

[0031] The inflation sub-step can be implemented by the processing means.

[0032] The detection sub-step is implemented by the processing means.

[0033] The recording of the measured pressure is implemented by the processing means.

[0034] The second measurement step may further include:

[0035] a sub-step of detecting a stoppage of the contraction applied to the inflatable body by the person's perineum causing the recording of the pressure within the inflatable body to stop.

[0036] The stop detection sub-step is implemented by the processing means.

[0037] The second measurement step may further comprise, for example after the step of detecting the cessation of the first contraction:

[0038] a sub-step of detecting an initiation of at least one second contraction applied to the inflatable body by the perineum of the person causing a recording of the pressure measured within the inflatable body by the second measuring means, and

[0039] a sub-step of recording the pressure measured within the inflatable body by the second measuring means caused by the detection of the initiation of the second contraction.

[0040] The detection sub-step is implemented by the processing means.

[0041] The recording of the measured pressure is implemented by the processing means.

[0042] The second measurement step may further include:

[0043] a sub-step of detecting a stoppage of the second contraction applied to the inflatable body by the person's perineum causing the recording of the pressure within the inflatable body to stop.

[0044] The stop detection sub-step is implemented by the processing means.

[0045] For example, the initiation of the first and / or second contraction may be detected from the measurement data of the first and second measuring means. The initiation of the first and / or second contraction is detected by the processing means.

[0046] For example, the stopping of the first and / or second contraction can be detected from the measurement data of the second measuring means, the stopping of the first and / or second contraction being detected by the processing means.

[0047] The method may comprise a succession of second measurement steps, the inflatable body inserted at least partially into the genital tract of the person being inflated according to a different predetermined dimension setting for each second measurement step.

[0048] For example, the method comprises between each second measuring step, a step in which the inflatable body is, at least in part, for example in its entirety, deflated.

[0049] Deflation of the inflatable body can be implemented by the processing means.

[0050] The method may comprise a step in which a perineal tone value is calculated or determined from the pressure measured within the inflatable body during the second measurement step. The perineal tone value is calculated or determined by the processing means.

[0051] For example, the tonicity value is calculated from the pressure measurement recorded during the second measurement step.

[0052] For example, the tonicity value is calculated or determined from an average of the recorded pressure (for example the average of the pressure values ​​reported in the second around the highest measured value).

[0053] For example, when several contractions are applied, the tonicity value is calculated or determined from an average of the pressure averages recorded for each of the contractions (for example the average of the pressure values ​​recorded in the second around the highest measured value).

[0054] For example, the method may comprise a step in which a signal, for example a visual signal, representative of a calculated tonicity value is emitted, for example by external equipment.

[0055] For example, the tonicity value may be calculated or determined from the recorded pressure measurement and a contraction duration measured during said recording.

[0056] For example, the duration of the contraction can be measured by the processing means.

[0057] The tone value is calculated or determined by the processing means.

[0058] For example, when several contractions are applied, the tonicity value is calculated or determined from an average of the pressure averages recorded for each of the contractions (for example the average of the pressure values ​​recorded in the second around the highest measured value) and the contraction durations measured during said recordings.

[0059] For example, the method may comprise a step in which a signal, for example a visual signal, representative of a calculated tonicity value is emitted, for example by external equipment.

[0060] According to another aspect, the invention relates to a system intended for monitoring a person's perineal rehabilitation, the system comprising processing means configured to implement the method as previously described.

[0061] For example, the system includes a device for monitoring a person's perineal rehabilitation, the device including:

[0062] an inflatable body intended to be placed at least partly in the genital tract of the person,

[0063] means of inflating and / or deflating the inflatable body,

[0064] first measuring means configured to measure a dimension of the inflatable body and / or second measuring means configured to measure a pressure within the inflatable body,

[0065] a processing unit configured to acquire measurement data from the first measuring means and the second measuring means, the processing means comprising the processing unit.

[0066] For example, the processing means are configured to calculate in real time a perineum tone value from the measurement data provided by the second measurement means, and transmit the tone value to external equipment, and / or the processing means are configured to transmit in real time measurement data provided by the second measurement means to the external equipment, the external equipment being configured to calculate in real time a tone value from the measurement data transmitted by the processing means.

[0067] The system may comprise a human-machine interface in communication with the processing unit of the device, configured to emit in real time a signal, for example a visual signal, representative of a perineum tone value calculated from the measurement data of the second measurement means.

[0068] The human-machine interface may be configured to emit in real time a first signal, for example a visual signal, representative of a first calculated tonicity value or a first range of calculated tonicity values, and at least one second signal different from the first signal, for example a visual signal, representative of a second calculated tonicity value different from the first calculated tonicity value or a second range of calculated tonicity values ​​different from the first calculated tonicity range.

[0069] The human-machine interface may comprise a mobile terminal in communication with the processing unit. The mobile terminal may be provided with a dedicated application configured to process data transmitted by the processing means. Brief description of the drawings

[0070] [Fig. 1] Figure 1 is an illustration of a device intended for monitoring the rehabilitation of a person's perineum according to the invention.

[0071] [Fig. 2] Figure 2 is a view of an inflatable body of the device according to the invention.

[0072] Figure 6 illustrates the inflatable body of the system according to an alternative embodiment.

[0073] [Fig. 3] Figure 3 illustrates the inflatable body of the system according to an alternative embodiment.

[0074] [Fig. 4] Figure 4 illustrates the inflatable body of the system according to an alternative embodiment.

[0075] [Fig. 5] Figure 5 illustrates the inflatable body of the system according to an alternative embodiment.

[0076] [Fig. 6] Figure 6 illustrates the inflatable body of the system according to an alternative embodiment.

[0077] [Fig. 7] Figure 7 illustrates the inflatable body of the system according to an alternative embodiment.

[0078] [Fig. 8] Figure 8 illustrates the inflatable body of the system according to an alternative embodiment.

[0079] [Fig. 9] Figure 9 illustrates the inflatable body of the system according to an alternative embodiment.

[0080] [Fig. 10] Figure 10 illustrates the device according to one embodiment of the invention.

[0081] [Fig. 11] Figure 11 illustrates the device according to one embodiment of the invention.

[0082] [Fig. 12] Figure 12 illustrates the device according to one embodiment of the invention.

[0083] [Fig. 13] Figure 13 illustrates a system according to one embodiment of the invention.

[0084] [Fig. 14] Figure 14 illustrates a human-machine interface in communication with the processing unit of the device, emitting in real time a visual signal, representative of a perineal tone value calculated from the measurement data of the second measurement means.

[0085] [Fig. 15] Figure 15 illustrates the device according to one embodiment of the invention. Description of the embodiments

[0086] In the remainder of the description of the method, device and system according to the invention, the same numerical references designate the same elements.

[0087] Figure 1 shows a device 1 intended for monitoring the rehabilitation of a person's perineum.

[0088] In the present disclosure, the device 1 is configured to implement a method for monitoring a person's perineal rehabilitation. The method according to the invention allows the person to monitor the progress of the effects of their perineal rehabilitation. The method according to the invention will be described in more detail below.

[0089] The device 1 comprises an inflatable body 2 intended to be placed at least partly in the genital tract of the person, means 4 for inflating and / or deflating the inflatable body 2, first measuring means 6 configured to measure a dimension of the inflatable body, and / or second measuring means 5 configured to measure a pressure within the inflatable body. The device 1 further comprises a processing unit 8 configured to acquire measurement data from the first measuring means 6 and the second measuring means 5.

[0090] The processing unit 8 can be supported by an electronic card 7, for example integrated into a housing of the device 1.

[0091] The inflatable body 2 is intended to be placed at least partially in the genital tract of the person. The inflatable body 2 may comprise a material compatible with the human body, for example the inflatable body 2 may comprise latex or silicone.

[0092] In the present disclosure, the inflatable body 2 may be inflated after being inserted, at least in part, into the genital tract of the person.

[0093] In the present disclosure, the inflatable body 2 is adapted to withstand contraction forces applied by the person's perineum to the inflatable body 2, for example when the inflatable body 2 is inflated.

[0094] As illustrated in Figure 2, the inflatable body 2 may comprise a wall 20 whose thickness is adapted to withstand contraction forces exerted on the inflatable body, for example by the person's perineum.

[0095] The inflatable body 2 is configured to be inflated, for example by filling the inflatable body with a fluid, for example air, and to be deflated, for example by emptying the inflatable body.

[0096] The wall 20 of the inflatable body 2 may comprise a first open end 22 intended to allow air to enter the inflatable body or air to exit the inflatable body and a second closed end 24 opposite the first end 22.

[0097] The inflatable body 2 can be inflated and / or deflated by inflation and / or deflation means 4 which are for example fluidically connected to the open end 204 of the inflatable body 2, for example by means of a conduit 12, for example a flexible hose.

[0098] The inflatable body can be inflated manually or automatically.

[0099] According to a first embodiment illustrated in Figure 1, the inflation device 4 comprises a manual inflation bulb (Figure 15). In this embodiment, the manual bulb may comprise a valve (not shown) allowing the inflatable body 2 to be slightly or completely deflated.

[0100] According to a second embodiment, the inflation and / or deflation means 4 can be motorized (figure 10).

[0101] For example, the inflation means may include a 4'' motor, the motor operating, for example, as an air pump.

[0102] For example, the motor is a solenoid electric motor with an adapter designed to pump air from the atmosphere through an opening provided for this purpose.

[0103] For example, the deflation means may comprise a solenoid valve 14 allowing the inflatable body 2 to be slightly or completely deflated.

[0104] The 4" motor and the solenoid valve 12 are connected to the processing unit 8 by means of conductive connections, for example by conductive wires 36, 37.

[0105] For example, automatic inflation may be implemented by the processing unit 8.

[0106] For example, the motor and / or the solenoid valve may be integrated into a housing of the device, for example in the same housing as that containing the electronic card 7 and / or the processing unit 8.

[0107] In the present disclosure, the inflatable body 2 may have a portion of constant or variable section when it is inflated.

[0108] For example, the wall 20 of the inflatable body has a tubular portion of constant or variable section.

[0109] Examples of wall shapes are shown in Figures 3 to 9 which illustrate longitudinal sectional views of the inflatable body 2 according to several embodiment variants.

[0110] In the example shown in Figure 1, the second end 24 of the wall may comprise a bulge 25. The bulge 25 allows a lubricated element to be fixed to the inflatable body to facilitate insertion of the inflatable body 2 into the genital tract of the person.

[0111] In the present disclosure, the inflatable body 2 may comprise means for facilitating the insertion of said at least one portion of the inflatable body 2 into the genital tract of the person, for example when the inflatable body is deflated.

[0112] For example, the inflatable body includes a central support 200 extending within the inflatable body 2.

[0113] For example, the central support 200 may be a rod, for example a semi-rigid rod. The semi-rigid rod may comprise a first free end portion 202 extending at a middle section of the inflatable body 2 and a second end portion 204 connected to the open end 22 of the inflatable body 2.

[0114] For example, the semi-rigid rod is fixed to a neck arranged at the open end 22 of the inflatable body. For example, the neck can form a handle 10 on which the inflatable body 2 is fixed, for example on which the open end 22 of the inflatable body is fixed.

[0115] The handle 10 is configured to allow the inflatable body to be manipulated and to guide the insertion of said at least one inflatable body part 2 into the genital tract of the person.

[0116] In the present disclosure, the device may comprise a gripping means 400 (figure 1) intended to allow optimization of the positioning of the inflatable body in the genital tract of the person and the removal of the inflatable body. For example, the gripping means being a semi-rigid handle.

[0117] In one example, the semi-rigid handle is telescopic. For example, the handle can have a maximum length of 40 cm in the extended position.

[0118] In the present disclosure, the pressure measuring means 5 may comprise at least one pressure sensor 34, for example two pressure sensors 34 (FIG. 10). The pressure sensor(s) is / are configured to measure in real time the pressure prevailing inside the inflatable body 2. For example, the pressure sensors 34 may be integrated into a housing of the device, for example in the same housing as that containing the electronic card 7 and / or the processing unit 8.

[0119] In the present disclosure, the processing unit 8 is configured to acquire measurement data from the pressure measuring means 5, for example pressure sensors 34. The measurement data is collected constantly and regularly.

[0120] The pressure measuring means 5, for example the pressure sensors 34, are for example connected to the processing unit 8 by means of conductive connections, for example conductive wires.

[0121] In the present disclosure, the inflatable body dimension measuring means 6 may be configured to measure a dimension of the inflatable body corresponding to a cross-section “T” of the inflatable body 2.

[0122] A cross-section “T” is understood to mean a section of the inflatable body considered transversely to a direction of insertion “d” of the inflatable body into the genital tract.

[0123] For example, the dimension measuring means 6 are configured to measure physical quantities making it possible to obtain a dimension of the inflatable body.

[0124] For example, the dimension measuring means 6 allow the device 1 to be arranged to determine a diameter “D” of the circular cross-section of the inflatable body as a function of the physical quantities measured by the measuring means 6.

[0125] According to a first embodiment illustrated in figures 11 and 12, the dimension measuring means 6 can be integrated into the inflatable body 2.

[0126] In this embodiment, the dimension measuring means 6 comprise at least one distance sensor 6'.

[0127] For example, the sensor 6' can be arranged on the central support 200 of the inflatable body 2. For example, the free end 202 of the central support 200.

[0128] The dimension measuring means 6 can be configured to measure a distance between the central support 200 and a point “P” located on an internal face of the wall 20 of the inflatable body.

[0129] This distance can correspond to a radius of the inflatable body.

[0130] For example, the 6' distance sensor is an infrared sensor.

[0131] The infrared sensor may include a transmitter and a receiver. The transmitter is configured to emit infrared light toward the wall of the inflatable body that is returned by the inflatable body and the receiver is configured to measure an amount of energy returned by the inflatable body.

[0132] In another example, the 6' distance sensor may be an ultrasonic sensor.

[0133] The ultrasonic sensor comprises a transmitter and a receiver. The transmitter is configured to transmit an ultrasonic signal towards the wall of the inflatable body which is returned by the inflatable body. The receiver is configured to count the time elapsed between the transmission of the ultrasonic signal and its reception to deduce a distance.

[0134] In yet another example, the 6' distance sensor may be a laser sensor. The laser sensor is a "time-of-flight" sensor comprising a transmitter and a receiver.

[0135] The transmitter is configured to emit laser radiation towards the wall of the inflatable body which is returned by the inflatable body. The receiver is configured to count the time elapsed between the emission of the laser radiation and its reception to deduce a distance.

[0136] In this example, the dimension measuring means 6 may comprise a light-emitting diode (LED) intended to provide illumination in the interior of the inflatable body.

[0137] In the example illustrated in Figure 12, said at least one distance sensor may be a camera such as a 6'' digital camera or camera and the inflatable body 2 comprises at least one pattern (not shown) or a rib 18 arranged on an internal face of the wall of the inflatable body.

[0138] The pattern can be, for example, a particular color or texture that is random or predetermined.

[0139] The pattern and rib are intended to allow the camera to detect distortion of the inflatable body.

[0140] For example, the inflatable body 2 comprises a plurality of ribs 18 arranged on the inner face of the wall of the inflatable body 2.

[0141] The imaging device makes it possible to know, in real time, a state of the internal face of the wall of the inflatable body. By comparing an image taken at a time T1, with an initial image taken at a time T0, it is possible to deduce, using image analysis, the increase in the dimension of the inflatable body. For example, the measuring device 6 may comprise a light-emitting diode (LED) 30 intended to provide lighting in the interior of the inflatable body.

[0142] For example, conductive wires can pass through the handles 10 (figures 11 and 12).

[0143] In the present disclosure, the processing unit 8 is configured to acquire measurement data from the distance measuring means 6, for example distance sensors.

[0144] The distance measuring means 6 are for example connected to the processing unit 8 by means of conductive connections, for example conductive wires.

[0145] For example, the distance sensors are used to measure a radius of the inflatable body. The diameter of the inflatable body can be obtained / calculated from the measured radius by means of the processing unit 8.

[0146] According to a second embodiment illustrated in figure 10, the means 6 for measuring the dimension of the inflatable body can be arranged outside the inflatable body 2.

[0147] In this embodiment, the measuring device 6 may comprise said at least one pressure sensor 34 of the pressure measuring means 5 and means 40 configured to calculate a quantity of air entering the inflatable body and / or leaving the inflatable body.

[0148] In the present disclosure, the means 40 configured to calculate a quantity of air entering the inflatable body and / or leaving the inflatable body may comprise a flow meter. For example, the flow meter 40 may be configured to measure a quantity of air entering the inflatable body using information communicated by the motor 4''. For example, the flow meter 40 may be configured to calculate a quantity of air leaving the inflatable body using information communicated by the solenoid valve 14.

[0149] In the present disclosure, the processing unit 8 is configured to acquire measurement data from the distance measuring means 6. The flow meter can be connected to the processing unit 8 by means of conductive connections.

[0150] In this embodiment, the dimension measuring means 6 are arranged to enable a dimension of the inflatable body to be obtained by the pressure measurement data and the air quantity measurement data, or by the pressure measurement data, the air quantity measurement data and the temperature measurement data.

[0151] For example, the dimension measuring means 6 may comprise a temperature sensor (not shown), for example connected to the processing unit.

[0152] The diameter of the inflatable body can be obtained / calculated from the measured data, by means of the processing unit 8 configured to process the acquired measurement data. For example, the dimension or diameter of the inflatable body can be obtained by the processing unit based on the ideal gas law and the relationship PV=nRT in which: P corresponds to the pressure which is determined by means of the pressure sensor 34; T corresponds to the temperature which is determined either by means of the temperature sensor, in this case the measuring device comprises at least one temperature sensor (not shown), or by an estimation of the ambient temperature; R corresponds to the universal ideal gas constant equal to 8.314 J mol 1 K 1 ; n corresponds to the quantity of air entering or leaving the inflatable body which is calculated by the calculator and which is determined via information communicated by the engine (the duration of ignition of the engine and its flow rate as a function of the pressure makes it possible to know the quantity of air blown in by the balloon) and / or via information communicated by the solenoid valve (the duration of opening of the solenoid valve and the pressure makes it possible to know the quantity of air leaving the balloon, to be deducted from the quantity of air blown in by the engine).

[0153] These parameters make it possible to deduce the volume of air present in the inflatable body. From this volume can be deduced the diameter of the inflatable body by knowing the shape of the inflatable body. Alternatively or in addition, from this volume can be deduced the diameter of the inflatable body by a series of tests, for example preliminary tests, making it possible to know the behavior of the inflatable body, the series of tests comprising for example the implementation by the processing means, for example as described below, of a series of measurements of the diameter and / or the pressure to deduce a behavior of the inflatable body as a function of the pressure.

[0154] Figure 13 represents a system 100 for monitoring perineal rehabilitation according to one embodiment. The system is configured to implement the method intended for monitoring a person's perineal rehabilitation which will be described in more detail later. The system further comprises processing means 80 configured to implement the method which will be described in more detail later.

[0155] The system 100 further comprises the device 1 as previously described and external equipment 9 comprising for example a processing unit 91.

[0156] The processing means 80 of the system comprise the processing unit 8 of the device and / or the processing unit of the external equipment 9.

[0157] The electronic card 7 of the device supports the processing unit 8 and means for recording and amplifying the measurement data of the first dimension measurement means 5 and the second pressure measurement means 6. The processing unit 8 is configured to acquire the measurement data from the pressure measurement means 6 and dimension measurement means 5 which are then processed by the processing unit 8. The processing unit 8 may be of the microprocessor or microcontroller type. The electronic card 7 may be powered by a battery, a battery or mains power. The processing unit 8 or the electronic card 7 is configured to be able to communicate with the external equipment 9. The external equipment 9 may comprise a human-machine interface 90, for example a mobile terminal such as a smartphone 900.

[0158] The processing unit 8 is connected to the external equipment 9, for example the human-machine interface 90, for example the mobile terminal or smartphone 900 by a wired or preferably wireless communication link, for example of the Bluetooth or BLE ("Bluetooth Low Energy") type. For example, the mobile terminal such as the smartphone 900 may include an application dedicated to monitoring the progress of the perineal rehabilitation. The screen of the mobile terminal or smartphone can thus be used to emit signals, for example visual signals, making it possible to monitor the progress of the effects of the rehabilitation as part of the method for monitoring a person's perineal rehabilitation.

[0159] The method for monitoring a person's perineal rehabilitation is described. The method is implemented, for example, using the device or system as previously described.

[0160] The method comprises an insertion step in which at least a portion of the inflatable body 2 is inserted into the genital tract of the person.

[0161] During the insertion step, for example, only a first part of the inflatable body 2 is inserted into the genital tract of a person.

[0162] For example, the first part of the inflatable body 2 corresponds to the part of the inflatable body with the largest diameter.

[0163] The insertion step is for example implemented so that the part of the inflatable body having the largest diameter is arranged at the entrance to the genital tract when the inflatable body 2 is inflated. This makes it possible to obtain an accurate assessment of the dimension of the genital tract.

[0164] The method may comprise a step in which the device 1, for example the processing unit 8 of the device, is connected to the external equipment such as the mobile terminal 900. The connection is made by communication, for example of the Bluetooth or BLE ("Bluetooth Low Energy") type.

[0165] The method may comprise a step in which the dedicated application of the external equipment, for example the mobile terminal, is launched.

[0166] The method may further comprise a measuring step, called the first measuring step, in which the inserted inflatable body is inflated, for example automatically, according to a predetermined pressure setpoint and the dimension of the inflatable body is measured by the first measuring means 6.

[0167] The processing unit 8 of the device can be configured to collect measurement data from the initiation of balloon inflation, for example.

[0168] For example, the first measurement step may include:

[0169] - an inflation sub-step in which the inflatable body is inflated, for example automatically, according to the predetermined pressure setpoint,

[0170] - a sub-step of detecting the initiation of a first contraction applied to the inflatable body by the person's perineum causing a stop, for example automatically, of the inflation of the inflatable body, and

[0171] - a sub-step of recording the dimension reached by the inflatable body.

[0172] For example, the detection sub-step is performed after the inflation sub-step and the recording sub-step is performed after the detection sub-step.

[0173] The detection sub-step can be implemented by the processing unit 8 of the device.

[0174] The recording sub-step can be implemented by the processing unit 8 of the device.

[0175] This first step consists of a so-called passive assessment of the perineum in the monitoring of the person's perineal rehabilitation.

[0176] When the inflatable body is inflated in the person's genital tract and a first contraction is detected, this means that the inflatable body has reached a size relative to that of the person's genital tract. The inflatable body then stops inflating. The size reached by the inflatable body makes it possible to deduce the passive tone of the person's perineum.

[0177] For example, the smaller the measured dimension, the more toned the perineum can be considered. Conversely, the larger the measured dimension, the less toned the perineum can be considered. A range of dimension values ​​can be between 1 cm and 8 cm, for example.

[0178] In the present disclosure, the pressure setpoint may be determined such that the inflatable body reaches a minimum dimension in the inflated state. This setpoint may, for example, be pre-recorded. For example, the pressure setpoint may be determined such that the inflatable body has a minimum diameter of between 1 and 5 cm, for example between 2 and 4 cm, for example 3 cm in the inflated state.

[0179] For example, the pressure setpoint may be an overpressure setpoint, for example in relation to an initial pressure and / or in relation to atmospheric pressure, for example a pressure setpoint between 5 and 30 kPa, for example between 5 and 20 kPa.

[0180] In the present disclosure, the initiation of the first contraction can be detected by the processing unit 8 of the device by means of the measurement data of the first dimension measuring means 6 and the second pressure measuring means 5 collected by the processing unit 8.

[0181] For example, the processing unit 8 may be arranged to detect an increase in pressure within the inflatable body while the size of the inflatable body no longer varies and to deduce therefrom an initiation of the contraction applied to the inflatable body 2 by the perineum. A contraction of the perineum is generally triggered when the size of the inflatable body reaches the size of the person's genital tract. In response to the stress caused by the inflatable body, the perineum contracts so as to resist further expansion of the inflatable body.

[0182] In the present disclosure, the sub-step of recording the dimension reached by the inflatable body can be processed by the processing unit 8 of the device.

[0183] Furthermore, the dimension reached by the inflatable body is obtained by the measurement data of the first measuring means 6 which are collected and processed by the processing unit 8.

[0184] The method may comprise, after the first measuring step, a step of displaying the dimension of the genital tract obtained from the dimension of the measured inflatable body.

[0185] The external equipment 9, for example the mobile terminal 900, can be configured to emit in real time a visual signal representative of the measured dimension.

[0186] The method may further comprise a measuring step, called the second measuring step, in which the inflatable body is inflated, for example automatically, according to a predetermined dimension setting and the pressure within the inflatable body is measured by the second measuring means.

[0187] The processing unit 8 of the device can be configured to collect measurement data from the initiation of balloon inflation, for example.

[0188] For example, the second measurement step may include

[0189] - a sub-step of inflating the inflatable body, for example automatically, according to the predetermined dimension instruction,

[0190] - a sub-step of recording the pressure, called initial pressure, measured within the inflatable body by the second measuring means when the inflatable body has reached the predetermined dimension,

[0191] - a sub-step of detecting the initiation of a first contraction applied to the inflatable body by the person's perineum, causing a recording of the pressure measured within the inflatable body by the second measuring means, and

[0192] - a sub-step of recording the pressure, called contraction pressure, measured within the inflatable body by the second measuring means caused by the detection of the initiation of the first contraction.

[0193] For example, the sub-step of recording the initial pressure measured within the inflatable body is carried out after the inflation sub-step, the detection sub-step is carried out after the sub-step of recording the initial pressure measured and the sub-step of recording the contraction pressure is carried out after the detection sub-step.

[0194] The inflation sub-step can be implemented by the processing unit 8 of the device.

[0195] The detection sub-step can be implemented by the processing unit 8 of the device.

[0196] The sub-steps of recording the initial pressure and the contraction pressure can be implemented by the processing unit 8 of the device.

[0197] This second measurement step also makes it possible to assess so-called active perineal tone in monitoring the person's perineal rehabilitation.

[0198] In this step, the person is asked to contract their perineum on the inflatable body voluntarily.

[0199] This second measurement step also makes it possible to measure the contraction force of the perineum by measuring the pressure applied by the person's perineum on the inflatable body.

[0200] For example, the method may comprise, after the step of recording the initial pressure, a step in which the external equipment emits a signal by example by means of a visual or audible signal indicating that at least one contraction can be applied by the person. The external equipment is configured to emit a signal to indicate that at least one contraction can be applied by the person.

[0201] In the present disclosure, the diameter setpoint may be determined so that the inflatable body has a minimum dimension, for example a minimum diameter in the inflated state. For example, the dimension setpoint may be determined so that the inflatable body has a diameter of between 1 and 8 cm, for example between 2 and 6 cm, for example 3 and 5 cm in the inflated state. The setpoint may be pre-recorded.

[0202] For example, the method may comprise, after the inflation sub-step, a sub-step of adjusting the dimension of the inflatable body, for example by plus or minus 1 cm. The adjustment of the dimension of the inflatable body 2 may be carried out using the dedicated application. The adjustment may be carried out by controlling the inflatable / deflated devices, for example by means of the control unit 8.

[0203] According to one embodiment, the method according to the invention may comprise the first measurement step and the second measurement step. For example, the first measurement step may be carried out before the second measurement step. Carrying out the first measurement step and the second measurement step allows for complete monitoring of the progress of the perineal rehabilitation (passive and active assessment).

[0204] The method may further comprise a step in which the inflatable body is deflated, for example completely, between the first measuring step and the second measuring step. The deflation of the inflatable body may be implemented by the control unit 8.

[0205] In this embodiment, the diameter setpoint can be determined by means of the dimension of the inflatable body which was measured during the first measuring step.

[0206] Thus the method can comprise, before the second measurement step, a step of determining the dimension setpoint by means of the dimension of the body. inflatable measured during the first measurement step. The dimension setpoint can be determined by the processing unit 8 of the device.

[0207] The inflatable body can then automatically inflate to the diameter predetermined during the first measurement step.

[0208] This also allows the person to have suitable and personalized monitoring.

[0209] For example, the initiation of the contraction can be detected by means of the measurement data of the second measuring means. The detection can be implemented by the processing unit 8 of the device.

[0210] For example, the processing unit 8 of the device can be configured to detect a change in pressure within the inflatable body relative to the value of the initial pressure measured and to deduce therefrom an initiation of the contraction applied by the person's perineum on the inflatable body.

[0211] In the present method, the contraction applied may be brief, for example of the order of 0.5 seconds.

[0212] In the present method, the contraction can be maintained over time. For example, for the maximum possible time.

[0213] In this case, the second measurement step may comprise a sub-step in which a contraction duration is measured. The contraction duration may for example be measured by the processing unit 8 of the device.

[0214] Contraction duration can be defined as the time between the measured contraction pressure exceeding the initial pressure measured in the second measurement step by more than 0.76 kPa (indicative of contraction initiation) and the measured pressure falling below 0.76 kPa of the initial pressure measured in the second measurement step (indicative of contraction cessation). A pressure of 0.7 kPa is considered a minimum pressure considered a contraction in scientific publications.

[0215] For example, the second measurement step may include a sub-step of recording the measured contraction duration. For example, the sub-step recording of the contraction duration is carried out at the same time as the sub-step of recording the measured contraction pressure.

[0216] The recording sub-steps can be implemented by the processing unit 8 of the device.

[0217] According to a first embodiment, the second measurement step may further comprise a sub-step of detecting a stoppage of the contraction applied to the inflatable body by the perineum of the person causing the recording of the pressure within the inflatable body and / or the duration of contraction to stop.

[0218] For example, the cessation of the contraction can be detected by means of the measurement data of the first and second measuring means. The determination of the cessation of the contraction can be implemented by the processing unit 8 of the device.

[0219] For example, the processing unit is configured to detect a return of pressure within the inflatable body around the value of the initial pressure measured and to deduce from this a cessation of the contraction applied by the person's perineum on the inflatable body.

[0220] According to another embodiment, the second measuring step may further comprise a sub-step of stopping the recording of the pressure within the inflatable body and / or the duration of contraction after a predetermined duration.

[0221] For example, the recording of the contraction pressure measurement or the recording of the contraction pressure measurement and the contraction duration may stop after a specified time has elapsed from the start of the recording. The time may be between 5 and 20 seconds, for example 10 and 15 seconds, for example 10 seconds.

[0222] In the method according to the invention, several contractions, for example brief or sustained over time, can be applied to the inflatable body.

[0223] For example, the second measurement step may include, for example after the recording stop step for the first contraction:

[0224] a sub-step of detecting an initiation of at least one second contraction applied to the inflatable body 2 by the perineum of the person causing a recording of the pressure measured within the inflatable body by the second measuring means, and

[0225] a sub-step of recording the pressure measured within the inflatable body 2 by the second measuring means.

[0226] These steps can be implemented by the processing unit 8.

[0227] For example, the second measurement step may include, for example, after the recording stop step for the second contraction:

[0228] a sub-step of detecting the initiation of a third contraction applied to the inflatable body by the person's perineum, causing a recording of the pressure measured within the inflatable body by the second measuring means, and

[0229] a sub-step of recording the pressure within the inflatable body by the second measuring means.

[0230] These steps can be implemented by the processing unit 8.

[0231] The method may comprise, for each contraction, a step of recording the contraction pressure or a step of recording the contraction pressure and the duration of contraction applied as previously described.

[0232] The method may comprise, before each step of determining a new contraction, a step of detecting a stoppage of the previous contraction.

[0233] These steps can be implemented by the processing unit 8.

[0234] For example, contractions can be spaced apart, for example, by at least 30 seconds, for example, by 60 seconds.

[0235] Furthermore, the method may comprise a succession of second measurement steps.

[0236] For example, for each second measurement step, the inflatable body inserted at least partially into the person's genital tract can be inflated according to a different predetermined dimension instruction. Tl

[0237] For example, the method may include a dimension measuring step in which the inflatable body may be inflated to a dimension setpoint, for example, a diameter of 3 cm and one or more contractions may be applied, then a dimension measuring step in which the inflatable body may be inflated to a dimension setpoint, for example, a diameter of 4 cm and one or more contractions may be applied, then a dimension measuring step in which the inflatable body may be inflated to a dimension setpoint, for example, a diameter of 5 cm and one or more contractions may be applied.

[0238] For example, the method may comprise between each second measuring step, a step in which the inflatable body is, at least in part, for example in its entirety, deflated.

[0239] Deflation of the inflatable body can be implemented by the processing unit 8 of the device.

[0240] The method according to the invention may further comprise a step in which, according to one embodiment, a perineal tone value is calculated or determined from the pressure measured within the inflatable body during the second measurement step. The perineal tone value may be calculated or determined by the processing unit 8 of the device.

[0241] For example, the step of calculating the tonicity value can be performed after the second measurement step.

[0242] For example, the tone value is calculated or determined from the contraction pressure recorded during the second measurement step.

[0243] For example, the tonicity value is calculated or determined from an average of the pressure values ​​measured and recorded during the second measurement step (for example the average of the pressure values ​​reported in the second around the highest measured value).

[0244] The tone value is determined based on the modified Oxford scale scoring technique (see [Tab. 1] below).

[0245] [Table 1]

[0246]

[0247] The tone value (absent, very low, low, average, good, very good) is deduced based on the value range in which the average of the recorded pressure values ​​is included.

[0248] For example, when several contractions are applied, the tonicity value is calculated or determined from an average of the pressure averages recorded for each of the contractions (for example the average of the pressure values ​​recorded in the second around the highest measured value).

[0249] For example, the method may comprise a step in which a signal, for example a visual signal, representative of a calculated tonicity value is emitted, for example by the external equipment 9, for example the smartphone 900.

[0250] For example, the method may comprise a step in which a signal, for example a visual signal, representative of a calculated tonicity value is displayed on a screen, for example of the external equipment 9, for example of the mobile terminal 900.

[0251] The external equipment 9 such as the interface 90 or the terminal 900 is thus configured to emit in real time a signal, for example a visual signal, representative of the calculated tonicity value.

[0252] For example, the signal may be a score between 0.0 and 5.0 representative of the calculated perineal tone value. A score equal to zero being representative of the “absent” tone value, and five being representative of the “very good” tone value. The external equipment 9 such as the interface 90 or the terminal 900 is thus configured to emit a signal in real time, the signal being a function of the calculated tone value.

[0253] For example, the human-machine interface is configured to emit in real time a first signal, for example a visual signal, representative of a first calculated tonicity value or a first range of calculated tonicity values, and at least one second signal different from the first signal, for example a visual signal, representative of a second calculated tonicity value different from the first calculated tonicity value or a second range of calculated tonicity values ​​different from the first calculated tonicity range.

[0254] According to another embodiment, the perineal tone value can be calculated from the pressure measured within the inflatable body, for example the contraction pressure and the duration of the contraction recorded during the second measurement step. The perineal tone value can be calculated or determined by the processing unit 8 of the device.

[0255] For example, the step of calculating the tonicity value can be performed after the second measurement step.

[0256] For example, the tone value is calculated or determined from the recorded contraction pressure and the recorded contraction duration in the second measurement step.

[0257] For example, the value is calculated from an average of the recorded pressure (for example, the average of the pressure values ​​recorded in the second around the highest measured value) and the contraction duration recorded during the second measurement step.

[0258] The tone value is determined based on the modified Oxford scale scoring technique (see [Tab. 2] below).

[0259] [Table 2] Table 2 allocation r F h lte O airté dh minimum of

[0261] The tone value (absent, weak, average, good, very good) is deduced based on the value range in which the average of the recorded pressure values ​​is included and the duration of the contraction or contraction durations.

[0262] To calculate or determine the tonicity value, the applied contraction must meet both the duration and pressure criteria of the corresponding value. For example, a contraction for which an average recorded pressure is measured at 1.50 kPa for less than one second will be rated 1. Similarly, a contraction lasting 3 seconds and for which the average recorded pressure is measured at 0.4 kPa will also be rated 1.

[0263] When several contractions, for example three contractions are applied by the person on the inflatable body, the tonicity value can be calculated for each contraction, for example for each contraction from the value range in which the average of the recorded pressure values ​​is included and the duration of the contraction among the contractions. In this way, each contraction can be noted distinctly to allow a detailed analysis by the person consulting the notations.The method may comprise a step of selection from the values ​​calculated for the different contractions, for example as a function of an input made by means of the human-machine interface 90, for example by an input made by a user choosing a value from the values ​​calculated and for example displayed by the external equipment 9, and for example recording the chosen value, the selection and recording step being for example implemented by the processing means. Alternatively or in addition, the tonicity value may be calculated from an average of the averages of the pressures of. contraction recorded during the second measurement step and the contraction duration and / or contraction durations and / or an average of the contraction durations, recorded during the second measurement step.

[0264] For example, the method may comprise a step in which a signal, for example a visual signal, representative of a calculated tonicity value is displayed on a screen, for example of the external equipment 9, for example of the mobile terminal 900.

[0265] The external equipment 9 such as the interface 90 or the terminal 900 is thus configured to emit in real time a signal, for example a visual signal, representative of the calculated tonicity value.

[0266] For example, the signal may be a score between 0.0 and 5.0 representative of the calculated perineal tone value. A score equal to zero being representative of the “absent” tone value, and five being representative of the “very good” tone value. The external equipment 9 such as the interface 90 or the terminal 900 is thus configured to emit a signal in real time, the signal being a function of the calculated tone value.

[0267] The method may comprise a step in which a first signal, for example a visual signal, is displayed on a screen of the human-machine interface 9, for example the mobile terminal 9 (figure 14), when the perineum tone value is included in a first range of perineum tone values, and at least one second signal different from the first signal, for example a visual signal, when the perineum tone value is included in a second range of perineum tone values, greater than the first range of perineum tone values.

[0268] The external equipment 9 such as the interface 90 or the terminal 900 is thus configured to emit signals in real time, for example signals, representative of a perineum tone value.

[0269] For example, the human-machine interface is configured to emit in real time a first signal, for example a visual signal, representative of a first calculated tonicity value or a first range of calculated tonicity values, and at least one second signal different from the first signal, for example a visual signal, representative of a second calculated tonicity value different from the first calculated tone value or a second range of calculated tone values ​​different from the first range of calculated tone values.

[0270] Furthermore, all or part of the processing described above as being carried out, implemented and / or performed by the processing unit 8 can be carried out by the external equipment such as the interface 90, for example the terminal 900. Thus, the processing unit 8 can be configured to calculate in real time a perineum tone value, and transmit in real time the calculated force value to the external equipment. The processing unit 8 can also be configured to collect and record the measurement data from the pressure 6 and / or dimension 5 measuring means, and transmit them to the external equipment.

Claims

Claims

1. Method for monitoring a rehabilitation of the perineum of a person, the method comprising the implementation, for example by processing means (80): of a measuring step in which the inflatable body (2) inserted at least partly into the genital tract of the person is inflated according to a predetermined dimension setting and a pressure within the inflatable body (2) is measured by second measuring means (5).

2. Method according to claim 1 in which the method comprises implementing a succession of measurement steps, the inflatable body inserted at least partly into the genital tract of the person being inflated according to a predetermined dimension setting different for each measurement step.

3. Method according to claim 2 in which the method comprises implementing between each measuring step, a step in which the inflatable body is, at least in part, for example in its entirety, deflated.

4. Method according to one of claims 1 or 2 in which the method comprises the implementation: of a first measuring step in which an inflatable body (2) inserted at least partly into the genital tract of the person is inflated according to a predetermined pressure setpoint and a dimension of the inflatable body (2) is measured by first measuring means (6).

5. Method according to claim 4 in which external equipment is configured to emit in real time a visual signal representative of the measured dimension.

6. Method according to claim 4 wherein the inflation of the inflatable body of the first measuring step is carried out automatically and / or the inflation of the inflatable body of the second measuring step is carried out automatically.

7. A method according to any preceding claim comprising a further step of insertion in which the at least part of an inflatable body (2) is inserted into the genital tract of the person.

8. A method according to claim 7 wherein during the insertion step, only a first portion of the inflatable body (2) is inserted into the genital tract of the person.

9. A method according to claim 8 wherein the first part of the inflatable body (2) corresponds to one half of the inflatable body (2).

10. A method according to any one of claims 4 to 9 comprising: the first measuring step, and the second measuring step, the first measuring step being carried out before the second measuring step.

11. Method according to claim 10 in which the method comprises, before the second measurement step, a step of determining the dimension setpoint, implemented by the processing means (80), by means of the dimension of the inflatable body (2) measured during the first measurement step.

12. Method according to any one of the preceding claims in which the second measuring step comprises: a sub-step of inflating the inflatable body (2) according to a predetermined dimension setpoint, a sub-step of detecting an initiation of a first contraction applied to the inflatable body (2) by the perineum of the person causing a sub-step of recording the pressure measured within the inflatable body, and the sub-step of recording the pressure measured within the inflatable body.

13. Method according to claim 12 in which the second measuring step comprises: a sub-step of detecting an initiation of at least one second contraction applied to the inflatable body by the perineum of the person causing a sub-step of recording the pressure measured within the inflatable body, and the sub-step of recording the pressure measured within the inflatable body.

14. A method according to any one of claims 12 or 13 wherein the initiation of the first and / or second contraction is detected by means of measurement data of the dimension of the inflatable body (2) and of pressure within the inflatable body (2).

15. Method according to any one of the preceding claims in which the method comprises a step of calculating a tone value, implemented by the processing means (80), in which a perineum tone value is calculated by means of the pressure measured within the inflatable body during the second measurement step.

16. System (100) for monitoring a person's perineal rehabilitation, the system comprising processing means (80) configured to implement the method according to any one of claims 1 to 6 and 10 to 15.

17. System according to claim 16, comprising a device for monitoring a rehabilitation of the perineum of a person, the device comprising: an inflatable body (2) intended to be placed at least partly in the genital tract of the person, means for inflating and / or deflating (4) the inflatable body (2), first measuring means (6) configured to measure a dimension of the inflatable body, and / or second measuring means (5) configured to measure a pressure within the inflatable body, a processing unit (8) configured to acquire measurement data from the first and second measuring means, the processing means (80) comprising the processing unit (8).

18. System according to the preceding claim, in which: the processing means (80) are configured to calculate in real time a perineum tone value from the measurement data provided by the second measurement means, and transmit the tone value to an external device (9), and / or the processing means (80) are configured to transmit in real time measurement data provided by the second measurement means to the external device (9), the external device being configured to calculate in real time a tone value from the measurement data transmitted by the processing unit.

19. System according to any one of claims 16 to 18, the system comprising a human-machine interface (90) in communication with the processing unit (8) of the device, configured to emit in real time a signal, for example a visual signal, representative of a perineum tone value calculated from the measurement data of the second measurement means.

20. The system (100) of claim 19, wherein the human-machine interface comprises a mobile terminal (900) in communication with the processing unit (8) of the device.

21. System (100) according to any one of claims 19 or 20, wherein the human-machine interface (90) is configured to emit in real time a first signal, for example a visual signal, representative of a first calculated tonicity value or a first range of calculated tonicity values, and at least one second signal different from the first signal, for example a visual signal, representative of a second calculated tonicity value different from the first calculated tonicity value or a second range of calculated tonicity values ​​different from the first calculated tonicity range.