Method for monitoring perineal rehabilitation in a subject - Patent Application 20070122997

Abstract

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

Description

[Technical Field]

[0001] The present invention relates to a method for monitoring the progress of the effects of perineal rehabilitation and a system for implementing this method. [Background technology]

[0002] Perineal rehabilitation, or pelvic floor rehabilitation, is generally carried out in cases of urinary incontinence or after childbirth, for example, with the aim of strengthening the perineum.

[0003] In this context, it is of interest to be able to monitor the progress of the effect of perineal rehabilitation in a subject. Methods that allow for monitoring such rehabilitation are known from the prior art. These methods are known as "tests" and 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 be performed manually, for example, by inserting two fingers into the subject's genital tract and exerting perineal contractions on both fingers for as long as possible. A score representing perineal tone can be estimated from measurements of contraction duration and strength, reported on a scale known as the Modified Oxford Scale. This score generally ranges from 0, representing insufficient tone, to 5, representing very adequate tone.

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

[0006] A drawback of the above-mentioned monitoring methods is that they are based on subjective measurement data: on the one hand, the sensation of contraction force on the finger may vary from person to person, and on the other hand, the size of the finger and the amount of force it can exert may vary from person to person. Summary of the Invention

[0007] The present invention aims at at least partially to overcome in particular one of these drawbacks and, according to a first aspect, relates to a method for monitoring the rehabilitation of a subject's perineum, said method comprising, for example by means of processing means: a first measuring step in which an expandable body at least partially inserted into the subject's reproductive tract is expanded according to a predetermined pressure setpoint and the dimensions of the expandable body are measured by a first measuring means; and / or a second measuring step in which the expandable body inserted into the subject's reproductive tract is expanded according to a predetermined dimensional setting, and the pressure within the expandable body is measured by a second measuring means; This includes performing the following.

[0008] The method according to the present invention allows the progress of perineal rehabilitation to be monitored from objective measurement data. In addition, the inflatable body allows for adaptation to the subject's reproductive tract and provides personalized monitoring. Furthermore, the method allows for the complete monitoring of the progress of perineal rehabilitation through the assessment of the subject's active and / or passive perineal tone.

[0009] For example, an assessment of the active tension can be performed from measurements of the pressure within the inflatable body.

[0010] For example, an assessment of passive tone can be performed from measuring the dimensions of the inflatable body, e.g., the smaller the measured dimension, the more toned the perineum can be considered. Conversely, the larger the measured dimension, the more relaxed the perineum can be considered.

[0011] According to other features of the invention, the method according to the invention comprises one or more of the following optional features, which may be envisaged alone or in any possible combination:

[0012] The method includes implementing the first measuring step and / or the second measuring step by a processing means.

[0013] The processing means comprises at least one processing unit configured to control at least one first part of the first measurement step and / or at least one first part of the second measurement step.

[0014] Inflation of the expandable body in the first measuring step is performed automatically and / or inflation of the expandable body in the second measuring step is performed automatically.

[0015] For example, automatic inflation of the inflatable body may be achieved by the processing means.

[0016] The method includes an additional insertion step in which at least a portion of the expandable body is inserted into the subject's reproductive tract.

[0017] For example, during this insertion step, only a first portion of the expandable body is inserted into the subject's reproductive tract.

[0018] For example, the first portion of the expandable body corresponds to one half of the expandable body.

[0019] For example, the method may include a second measurement step, or a first measurement step and a second measurement step, the first measurement step being performed before the second measurement step.

[0020] For example, the method includes a first measuring step and a second measuring step, the first measuring step being performed before the second measuring step.

[0021] For example, the method may include, prior to the second measuring step, determining a set dimension value according to the dimensions of the expandable body measured during the first measuring step, the set dimension value being determined by the processing means.

[0022] For example, the method may include a step in which, between the first and second measuring steps, the expandable body is at least partially, eg completely, deflated.

[0023] Deflation of the expandable body may be achieved by a processing means.

[0024] For example, the second measurement step of this method may be: inflating the expandable body according to predetermined dimensional settings, e.g., automatically; detecting the onset of a first contraction exerted by the subject's perineum on the inflatable body; recording a pressure measured within the inflatable body after the substep of detecting the onset of the first deflation; Includes:

[0025] The substep of recording the pressure within the expandable body is triggered by detecting the onset of a first deflation.

[0026] The sub-step of expanding may be performed by a processing means.

[0027] The detecting sub-step is performed by a processing means.

[0028] The recording of the measured pressure is carried out by processing means.

[0029] The second measurement step is detecting cessation of contractions exerted by the subject's perineum on the inflatable body and ceasing recording of pressure within the inflatable body; It may further include:

[0030] The sub-step of detecting a stall is carried out by a processing means.

[0031] The second measuring step may, for example, be performed after the step of detecting the cessation of the first contraction. detecting the onset of at least one second contraction exerted on the inflatable body by the subject's perineum and causing a recording of pressure measured by the second measuring means within the inflatable body; recording the pressure measured by the second measuring means within the inflatable body resulting from the detection of the onset of the second deflation; It may further include:

[0032] The detecting sub-step is performed by a processing means.

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

[0034] The second measurement step is detecting cessation of a second contraction exerted by the subject's perineum on the inflatable body and ceasing recording of pressure within the inflatable body; It may further include:

[0035] The sub-step of detecting a stall is carried out by a processing means.

[0036] For example, the onset of the first contraction and / or the second contraction can be detected from the measurement data of the first measuring means and the second measuring means. The onset of the first contraction and / or the second contraction is detected by the processing means.

[0037] For example, the cessation of the first contraction and / or the second contraction may be detected from the measurement data of the second measuring means, and the cessation of the first contraction and / or the second contraction is detected by the processing means.

[0038] The method may include successive second measurement steps, wherein the expandable body, inserted at least partially within the subject's reproductive tract, is expanded according to different predetermined dimensional settings for each second measurement step.

[0039] For example, the method may include the step of the expandable body being at least partially, eg completely, deflated between each second measuring step.

[0040] Deflation of the expandable body may be achieved by a processing means.

[0041] The method may include the step of calculating or determining a value of perineal strain from the pressure measured in the inflatable body during the second measuring step, the value of perineal strain being calculated or determined by the processing means.

[0042] For example, the strain value is calculated from the pressure measurements recorded during the second measurement step.

[0043] For example, the strain value may be calculated or determined from the average value of the recorded pressures (for example, the average value of the pressure values ​​around the highest value measured in the second measurement step).

[0044] For example, when multiple contractions are applied, the tension value is calculated or determined from the average of the pressures recorded for each contraction (e.g., the average of the pressure values ​​near the highest value measured in the second measurement step).

[0045] For example, the method may include a step in which a signal, for example a visual signal, representing the calculated strain value is emitted, for example by an external device.

[0046] For example, the strain value may be calculated or determined from the recorded pressure measurements and the contraction period measured during that recording.

[0047] For example, the duration of contraction may be measured by the processing means.

[0048] The value of the tension is calculated or determined by the processing means.

[0049] For example, when multiple contractions are applied, the tension value is calculated or determined from the average of the pressures recorded for each contraction (e.g., the average of the pressure values ​​near the highest value measured in the second measurement step) and the contraction duration measured during that recording.

[0050] For example, the method may include a step in which a signal, for example a visual signal, representing the calculated strain value is emitted, for example by an external device.

[0051] According to another aspect, the invention relates to a system intended to monitor the rehabilitation of the perineum of a subject, said system comprising processing means adapted to implement the method described above.

[0052] For example, the system may include a device intended to monitor the rehabilitation of a subject's perineum, This device is an inflatable body intended to be at least partially disposed within the reproductive tract of a subject; means for inflating and / or deflating the expandable body; 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; a processing unit configured to acquire measurement data from the first measurement means and the second measurement means; The processing means comprises a processing unit.

[0053] For example, the processing means is configured to calculate a value of perineal tension in real time from the measurement data provided by the second measuring means and to transfer this tension value to an external device, and / or the processing means is configured to transfer the measurement data provided by the second measuring means to an external device in real time, and the external device is configured to calculate a value of tension in real time from the measurement data transferred by the processing means.

[0054] 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, representing the value of perineal tension calculated from the measurement data of the second measuring means.

[0055] The human-machine interface may be configured to emit in real time a first signal, e.g., a visual signal, representing a first calculated tension value or a first range of calculated tension values, and at least one second signal, e.g., a visual signal, different from the first signal, representing a second calculated tension value different from the first calculated tension value or a second range of calculated tension values ​​different from the first range of calculated tension values.

[0056] The human machine interface may comprise a mobile terminal in communication with the processing unit, the mobile terminal being provided with a dedicated application arranged to process data transferred by the processing means. [Brief explanation of the drawings]

[0057] [Figure 1] FIG. 1 is a diagram of an apparatus for monitoring the rehabilitation of a subject's perineum, according to the present invention. [Figure 2] FIG. 2 is a diagram of the inflatable body of a device according to the present invention. [Figure 3] FIG. 3 shows an inflatable body of a variant of the system. [Figure 4] FIG. 4 shows an inflatable body of a variant of the system. [Figure 5] FIG. 5 shows an inflatable body of a variant of the system. [Figure 6] FIG. 6 shows an inflatable body of a variant of the system. [Figure 7] FIG. 7 shows an inflatable body of a variant of the system. [Figure 8] FIG. 8 shows an inflatable body of a variant of the system. [Figure 9] FIG. 9 shows an inflatable body of a variant of the system. [Figure 10] FIG. 10 shows an apparatus according to an embodiment of the present invention. [Figure 11] FIG. 11 shows an apparatus according to an embodiment of the present invention. [Figure 12] FIG. 12 shows an apparatus according to an embodiment of the present invention. [Figure 13] FIG. 13 illustrates a system according to an embodiment of the present invention. [Figure 14] FIG. 14 shows a human-machine interface in communication with the processing unit of the device, which emits a visual signal in real time representing the value of perineal tension calculated from the measurement data of the second measurement means. [Figure 15] FIG. 15 shows an apparatus according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0058] In the following description of methods, apparatus, and systems according to the present invention, like reference numerals refer to like elements.

[0059] FIG. 1 shows a device 1 intended to monitor the rehabilitation of a subject's perineum (pelvic floor muscles).

[0060] In the present disclosure, the device 1 is configured to implement a method intended to monitor the rehabilitation of a subject's perineum. The method according to the invention allows the subject to monitor the progress of the effects of his or her perineum rehabilitation. The method according to the invention is described in more detail below.

[0061] The device 1 comprises an inflatable body 2 intended to be at least partially placed in the reproductive tract of a subject, means 4 for inflating and / or deflating the inflatable body 2, first measuring means 6 configured to measure the dimensions of the inflatable body and / or second measuring means 5 configured to measure the pressure within the inflatable body. The device 1 further comprises a processing unit 8 configured to obtain measurement data from the first measuring means 6 and the second measuring means 5.

[0062] The processing unit 8 may for example be supported by an electronic board 7 integrated into the housing of the device 1 .

[0063] The expandable body 2 is intended to be at least partially disposed within the reproductive tract of a subject. The expandable body 2 may comprise a material that is compatible with the human body. For example, the expandable body 2 may be made of latex or silicone.

[0064] In the present disclosure, the expandable body 2 may be expanded after being at least partially inserted into the subject's reproductive tract.

[0065] In the present disclosure, the expandable body 2 is configured to withstand contractile forces exerted on the expandable body 2 by the subject's perineum, for example, when the expandable body 2 is inflated.

[0066] 2, the inflatable body 2 may comprise a wall 20. The thickness of the wall 20 is configured to withstand contraction forces exerted on the inflatable body 2, for example, by the subject's perineum.

[0067] The expandable body 2 is configured to be expanded, for example, by filling the expandable body with a fluid, for example air, and to be deflated, for example, by emptying the expandable body.

[0068] The wall 20 of the inflatable body 2 may have a first open end 22 intended to allow air to enter or exit the inflatable body, and a second closed end 24 located opposite the first open end 22.

[0069] The expandable body 2 may be inflated and / or deflated by, for example, an inflation and / or deflation means 4 fluidly connected to the open end 204 of the expandable body 2 by, for example, a conduit 12, for example a flexible hose.

[0070] The expandable body can be expanded manually or automatically.

[0071] 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) that allows the inflatable body 2 to be slightly deflated or fully deflated.

[0072] According to a second embodiment, the inflation and / or deflation means 4 may be motor driven (FIG. 10).

[0073] For example, the inflation means comprises a motor 4'', which operates for example as an air pump.

[0074] For example, this motor is a solenoid motor including an adapter intended to admit air through an opening provided for admitting air from the surroundings.

[0075] For example, the deflation means may comprise a solenoid valve 14 that allows the inflatable body 2 to be slightly deflated or fully deflated.

[0076] The motor 4 ″ and the solenoid valve 12 are connected to the processing unit 8 by electrically conductive connections, for example by wires 36 , 37 .

[0077] For example, automatic inflation can be realized by the processing unit 8 .

[0078] For example, the motor and solenoid valves may be integrated into the housing of the device, for example in the same housing that contains the electronic board 7 and / or processing unit 8.

[0079] In the present disclosure, the expandable body 2 may have portions of constant cross section or portions of varying cross section when expanded.

[0080] For example, the wall 20 of the expandable body may have tubular portions of constant cross section or tubular portions of varying cross section.

[0081] Examples of wall shapes are shown in Figures 3-9, which show longitudinal cross sections of the expandable body 2 according to several variations.

[0082] 1, the second end 24 of the wall may include a protrusion 25. This protrusion 25 allows a lubricating element to be attached to the expandable body 2 to allow for easier insertion of the expandable body 2 into the subject's reproductive tract.

[0083] In the present disclosure, the expandable body 2 may comprise, for example, a means for facilitating insertion of at least a portion of the expandable body 2 into the reproductive tract of a subject when the expandable body is deflated.

[0084] For example, the expandable body includes a central support member 200 that extends into the expandable body 2 .

[0085] For example, the central support member 200 may be a rod, such as a semi-rigid rod, that may have a first free end 202 extending in a middle portion of the expandable body 2 and a second end 204 connected to the open end 22 of the expandable body 2.

[0086] For example, the semi-rigid rod is secured to a neck disposed at the open end 22 of the expandable body. For example, this neck may form a handle 10 to which the expandable body 2 is secured, e.g., to which the open end 22 of the expandable body is secured.

[0087] The handle 10 is configured to allow manipulation of the expandable body 2 and to allow guiding insertion of at least a portion of the expandable body 2 into the reproductive tract of a subject.

[0088] In the present disclosure, the device may comprise a gripping means 400 (FIG. 1) intended to allow for optimization of the positioning of the expandable body within the subject's reproductive tract and for removal of the expandable body, for example, the gripping means being a semi-rigid grip.

[0089] According to one example, the semi-rigid grip is telescoping, for example, the grip may have a maximum length of 40 cm in the deployed state.

[0090] In the present disclosure, the pressure measurement means 5 may comprise at least one pressure sensor 34, for example two pressure sensors 34 (Fig. 10), which pressure sensor(s) are configured to measure in real time the pressure inside the expandable body 2. For example, the pressure sensor 34 may be integrated into the housing of the device, for example the same housing that contains the electronic board 7 and / or the processing unit 8.

[0091] In the present disclosure, the processing unit 8 is configured to obtain measurement data from the pressure measurement means 5, for example the pressure sensor 34. This measurement data is collected continuously and periodically.

[0092] The pressure measuring device 5, eg a pressure sensor 34, is connected to eg a processing unit 8 by an electrically conductive connection, eg a wire.

[0093] In the present disclosure, the means for measuring a dimension of the expandable body 6 may be configured to measure a dimension of the expandable body corresponding to the cross section "T" of the expandable body 2.

[0094] Cross section "T" is understood to mean the cross section of the expandable body taken across the direction of insertion "d" of the expandable body into the reproductive tract.

[0095] For example, the dimension measuring means 6 are configured to measure physical quantities that make it possible to obtain the dimensions of the inflatable body.

[0096] For example, the dimension measuring means 6 enables the device 1 to be configured to determine the diameter “D” of a circular cross section of the expandable body as a function of the physical quantity measured by the measuring means 6 .

[0097] According to a first embodiment illustrated in FIGS. 11 and 12, the dimensioning means 6 may be integrated into the inflatable body 2 .

[0098] In this embodiment, the dimensioning means 6 comprises at least one distance sensor 6'.

[0099] For example, the sensor 6 ′ may be located at the central support member 200 of the inflatable body 2 , for example at the free end 202 of the central support member 200 .

[0100] The dimensioning means 6 may be configured to measure the distance between the central support member 200 and a point "P" located on the inner surface of the wall 20 of the inflatable body.

[0101] This distance may correspond to the radius of the expandable body.

[0102] For example, the distance sensor 6' is an infrared sensor.

[0103] The infrared sensor may include a transmitter and a receiver, the transmitter configured to emit infrared light toward a wall of the inflatable body where the infrared light is reflected by the inflatable body, and the receiver configured to measure the amount of energy reflected by the inflatable body.

[0104] According to another example, the distance sensor 6' can be an ultrasonic sensor.

[0105] The ultrasonic sensor may include a transmitter and a receiver, the transmitter configured to emit an ultrasonic signal toward a wall of the inflatable body, where the ultrasonic signal is reflected by the inflatable body, and the receiver configured to count the time elapsed between emitting the ultrasonic signal and receiving the ultrasonic signal to estimate distance therefrom.

[0106] According to yet another example, the distance sensor 6' can be a laser sensor, which is a "time of flight" sensor comprising a transmitter and a receiver.

[0107] The transmitter is configured to emit laser radiation towards a wall of the inflatable body, where the laser radiation is reflected by the inflatable body, and the receiver is configured to count the time elapsed between emitting the laser radiation and receiving the laser radiation and to infer distance therefrom.

[0108] In this example, the dimensioning means 6 may comprise a light emitting diode (LED) intended to provide illumination inside the inflatable body.

[0109] In the example illustrated in FIG. 12, the at least one distance sensor may be a camera such as a video camera or digital camera 6'', and the inflatable body 2 comprises at least one pattern (not shown) or rib 18 disposed on the inner surface of the inflatable body.

[0110] The pattern can be, for example, a color, a particular random texture, or a predetermined texture.

[0111] The pattern and ribs are intended to allow the camera to detect distortions in the inflatable body.

[0112] For example, the expandable body 2 comprises a plurality of ribs 18 disposed on the inner surface of the wall of the expandable body 2 .

[0113] This camera makes it possible to know in real time the condition of the inner surface of the wall of the inflatable body. By comparing an image taken at a given time T1 with an initial image taken at time T0, it is possible to estimate the increase in the dimensions of the inflatable body by means of image analysis. For example, the measuring device 6 may comprise a light-emitting diode (LED) 30 intended to provide illumination inside the inflatable body.

[0114] For example, the electrical leads may pass through the handle 10 (FIGS. 11 and 12).

[0115] In the present disclosure, the processing unit 8 is configured to obtain measurement data from the distance measurement means 6, for example a distance sensor.

[0116] For example, the distance measuring means 6 is connected to the processing unit 8 by an electrically conductive connection, for example a wire.

[0117] For example, the distance sensor makes it possible to measure the radius of the inflatable body, the diameter of which can be determined or calculated by the processing unit 8 from the measured radius.

[0118] According to a second embodiment illustrated in FIG. 10, the means 6 for measuring the dimensions of the inflatable body may be arranged outside the inflatable body 2 .

[0119] 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 the amount of air entering the inflatable body and / or the amount of air leaving the inflatable body.

[0120] In the present disclosure, the means 40 configured to calculate the amount of air entering and / or exiting the inflatable body may comprise a flow meter. For example, the flow meter 40 may be configured to measure the amount of air entering the inflatable body using information transmitted by the motor''4. For example, the flow meter 40 may be configured to calculate the amount of air exiting the inflatable body using information transmitted by the solenoid valve 14.

[0121] In the present disclosure, the processing unit 8 is configured to obtain measurement data from the distance measuring means 6. The flow meter may be connected to the processing unit 8 by a wire.

[0122] In this embodiment, the dimension measuring means 6 are configured to make it possible to determine the dimensions of the inflatable body from data representative of the pressure and data representative of the amount of air, or from data representative of the pressure, data representative of the amount of air and data representative of the temperature.

[0123] For example, the dimensioning means 6 may comprise a temperature sensor (not shown), for example connected to a processing unit.

[0124] The diameter of the inflatable body may be determined or calculated from the measured data by a processing unit 8 configured to process the acquired measurement data. For example, the dimension, i.e., diameter, of the inflatable body may be determined by the processing unit based on the ideal gas law and the equation of state PV=nRT, where: P corresponds to the pressure determined by the pressure sensor 34, T corresponds to the temperature determined either by the temperature sensor (not shown) if the measuring device is equipped with at least one temperature sensor, or by an estimate of the ambient temperature; R is 8.314 J mol -1 ·K -1 corresponds to the universal ideal gas constant, which is equal to n corresponds to the amount of air entering or leaving the inflatable body, which is calculated by the computer and determined via information transmitted by the motor (the motor's run time and air flow rate as a function of pressure are used to determine the amount of air blown into the balloon) and / or via information transmitted by the solenoid valve (the solenoid valve's open time and pressure are used to determine the amount of air leaving the balloon, which is subtracted from the amount of air blown into the balloon by the motor).

[0125] These parameters make it possible to estimate the volume of air present in the inflatable body. From this volume, the diameter of the inflatable body can be estimated by knowing the shape of the inflatable body. Alternatively, or additionally, the diameter of the inflatable body can be estimated from this volume by a series of tests, for example preliminary tests. This series of tests makes it possible to know the behavior of the inflatable body. For example, this series of tests comprises realizing by the processing means a series of diameter measurements and / or pressure measurements, for example as described below, from which the behavior of the inflatable body as a function of pressure is deduced.

[0126] 13 shows a system 100 for monitoring perineal rehabilitation according to one embodiment, configured to implement a method intended to monitor perineal rehabilitation in a subject, as will be described in more detail below. The system further comprises processing means 80 configured to implement this method, as will be described in more detail below.

[0127] The system 100 further comprises the device 1 as described above and an external device 9 comprising, for example, a processing unit 91 .

[0128] The processing means 80 of the system comprise a processing unit 8 of the device and / or a processing unit of an external device 9 .

[0129] An electronic board 7 of the device supports a processing unit 8 and means for recording and amplifying measurement data of the first dimension measuring means 5 and the second pressure measuring means 6. The processing unit 8 is configured to acquire measurement data from the pressure measuring means 6 and the dimension measuring means 5, which data are then processed by the processing unit 8. The processing unit 8 may be in the form of a microprocessor or microcontroller. The electronic board 7 may be powered by a cell, a battery or a power supply. The processing unit 8 or the electronic board 7 is configured to be able to communicate with an external device 9. The external device 9 may comprise a human-machine interface 90, for example a mobile terminal such as a smartphone 900.

[0130] The processing unit 8 is connected to an external device 9, for example a human-machine interface 90, for example a mobile terminal or smartphone 900, either by wire or preferably via a wireless communication connection, for example in the form of Bluetooth or BLE (Bluetooth Low Energy). For example, a mobile terminal such as smartphone 900 may be equipped with a dedicated application for monitoring the progress of perineal rehabilitation. Thus, the screen of the mobile terminal or smartphone may be used to emit signals, for example visual signals, allowing the progress of the rehabilitation effect to be monitored as part of a method for monitoring the rehabilitation of a subject's perineal tissue.

[0131] A method for monitoring the rehabilitation of a subject's perineum is described, which may be implemented, for example, by the device or system described above.

[0132] The method includes an insertion step in which at least a portion of the expandable body 2 is inserted into the subject's reproductive tract.

[0133] During the insertion step, for example, only the first portion of the expandable body 2 is inserted into the subject's reproductive tract.

[0134] For example, the first portion of the expandable body 2 corresponds to the portion of the expandable body having the largest diameter.

[0135] The insertion step is performed, for example, so that when the expandable body 2 is expanded, the part of the expandable body with the largest diameter is positioned at the entrance to the reproductive tract, which allows an accurate assessment of the dimensions of the reproductive tract to be obtained.

[0136] The method may comprise a step in which the device 1, for example the processing unit 8 of the device, is connected to an external device such as a mobile terminal 900. The connection is made by communication, for example Bluetooth or BLE (Bluetooth Low Energy).

[0137] The method may include a step in which a dedicated application on an external device, for example a mobile terminal, is launched.

[0138] The method may further comprise a measuring step, the so-called first measuring step, in which the inserted expandable body is inflated, for example automatically, according to a predetermined pressure setpoint and the dimensions of the expandable body are measured by first measuring means 6.

[0139] The processing unit 8 of the device may be configured to collect measurement data, for example, from the start of inflation of the balloon.

[0140] For example, the first measurement step is an inflation sub-step in which the inflatable body is inflated, for example automatically, according to a predetermined pressure set point; detecting the onset of a first contraction exerted by the subject's perineum on the inflatable body and causing, for example automatically, cessation of inflation of the inflatable body; the sub-step of recording the dimension reached by the expandable body; may include:

[0141] For example, the detecting substep is performed after the dilating substep, and the recording substep is performed after the detecting substep.

[0142] The detecting substep may be performed by a processing unit 8 of the device.

[0143] The recording sub-step may be performed by a processing unit 8 of the device.

[0144] This first step consists of a so-called passive assessment of the perineum in monitoring the rehabilitation of the subject's perineum.

[0145] The expandable body is expanded within the subject's reproductive tract, and when a first contraction is detected, this indicates that the expandable body has reached a dimension corresponding to the dimension of the subject's reproductive tract. The expandable body then stops expanding. The dimension reached by the expandable body allows for an estimation of the passive tension of the subject's perineum.

[0146] For example, the smaller the measured dimension, the more tense the perineum may be considered. Conversely, the larger the measured dimension, the more relaxed the perineum may be considered. The range of dimension values ​​may be, for example, between 1 cm and 8 cm.

[0147] In the present disclosure, the pressure setting value may be determined so that the expandable body reaches a minimum dimension in an expanded state. For example, this setting value may be pre-recorded. For example, the pressure setting value may be determined so that the expandable body has a minimum diameter in an expanded state comprised between 1 cm and 5 cm, for example comprised between 2 cm and 4 cm, for example 3 cm.

[0148] For example, the pressure set point may be a pressure set point that is higher than, for example, the initial pressure and / or higher than atmospheric pressure, for example, the pressure set point is comprised between 5 kPa and 30 kPa, for example between 5 kPa and 20 kPa.

[0149] In the present disclosure, the onset of the first contraction can be detected by the processing unit 8 of the device using the measurement data of the first dimension measuring means 6 and the second pressure measuring means 5 collected by the processing unit 8 .

[0150] For example, processing unit 8 may be configured to detect an increase in pressure within the expandable body when the expandable body ceases to change dimensions, and from this infer the onset of contraction exerted by the perineum on expandable body 2. Perineum contraction is generally triggered when the expandable body dimensions reach the dimensions of the subject's reproductive tract. In response to stresses exerted by the expandable body, the perineum contracts to resist further expansion of the expandable body.

[0151] In the present disclosure, the sub-step of recording the dimensions reached by the inflatable body may be handled by the processing unit 8 of the device.

[0152] Furthermore, the dimension reached by the inflatable body is determined by the measurement data of the first measuring means 6 , collected and processed by the processing unit 8 .

[0153] The method may include, after the first measuring step, displaying the dimensions of the reproductive tract determined from the measured dimensions of the expandable body.

[0154] The external device 9, for example a mobile terminal 900, may be configured to emit a visual signal in real time representing the measured dimension.

[0155] The method may further comprise a measuring step, a so-called second measuring step, in which the inflatable body is inflated, for example automatically, according to a predetermined dimensional setting and the pressure in the inflatable body is measured by a second measuring means.

[0156] The processing unit 8 of the device may be configured to collect measurement data, for example, from the start of inflation of the balloon.

[0157] For example, the second measurement step is inflating the inflatable body, e.g., automatically, according to a predetermined pressure set point; a sub-step of recording the pressure measured by the second measuring means in the inflatable body when the inflatable body reaches a predetermined dimension, the so-called initial pressure; detecting the onset of a first contraction exerted by the subject's perineum on the inflatable body; after the sub-step of detecting the onset of the first contraction, a sub-step of recording the pressure measured by the second measuring means in the inflatable body caused by the detection of the onset of the first contraction, the so-called deflation pressure; may include:

[0158] For example, the substep of recording the initial pressure measured within the inflatable body is performed after the substep of inflating, the substep of detecting is performed after the substep of recording the initial pressure measured, and the substep of recording the deflation pressure is performed after the substep of detecting.

[0159] The inflating sub-step may be carried out by the processing unit 8 of the device.

[0160] The detecting substep may be performed by a processing unit 8 of the device.

[0161] The sub-step of recording the initial pressure and the deflation pressure may be performed by the processing unit 8 of the device.

[0162] This second measurement step also makes it possible to assess the so-called active perineal tone when monitoring the rehabilitation of the subject's perineal tissue.

[0163] In this step, the subject is asked to voluntarily contract their perineum over the inflatable body.

[0164] This second measuring step also makes it possible to measure the contraction force of the perineum by measuring the pressure exerted by the subject's perineum on the inflatable body.

[0165] For example, the method may include, after the step of recording the initial pressure, the step of the external device emitting a signal, e.g., by a visual or audible signal, indicating that at least one contraction may be delivered by the subject, the external device being configured to emit the signal indicating that at least one contraction may be delivered by the subject.

[0166] In the present disclosure, a diameter setting may be determined so that the expandable body has a minimum dimension, e.g., a minimum diameter in an expanded state. For example, the size setting may be determined so that the expandable body has a diameter in an expanded state comprised between 1 cm and 8 cm, e.g., between 2 cm and 6 cm, e.g., between 3 cm and 5 cm. This setting may be pre-recorded.

[0167] For example, the method may comprise, after the inflating sub-step, a sub-step of adjusting the dimensions of the inflatable body, for example by adding or subtracting 1 cm. The adjustment of the dimensions of the inflatable body 2 may be performed using a dedicated application. This adjustment may be performed by controlling the inflation / deflation device, for example using the control unit 8.

[0168] According to some embodiments, the method of the present invention may include a first measurement step and a second measurement step. For example, the first measurement step may be performed before the second measurement step. Performing the first and second measurement steps allows for complete monitoring (passive and active assessment) of the progress of perineal rehabilitation.

[0169] The method may further comprise a step in which the inflatable body is, for example, fully deflated between the first and second measuring steps. Deflation of the inflatable body may be achieved by the control unit 8.

[0170] In this embodiment, the diameter set point may be determined using the dimensions of the expandable body measured during the first measuring step.

[0171] Thus, the method may comprise, prior to the second measuring step, a step of determining a set dimension value using the dimensions of the expandable body measured during the first measuring step, which set dimension value may be determined by a processing unit 8 of the apparatus.

[0172] The expandable body may then be automatically expanded to a predetermined diameter during the first measuring step.

[0173] This also allows subjects to receive tailored and personalized monitoring.

[0174] For example, the onset of a contraction may be detected using measurement data from the second measurement means, which may be realized by the processing unit 8 of the device.

[0175] For example, the processing unit 8 of the device may be configured to detect the change in pressure within the inflatable body relative to the initial pressure value measured and to deduce therefrom the onset of a contraction exerted by the subject's perineum on the inflatable body.

[0176] In this method, the contraction applied may be of short duration, for example, on the order of 0.5 seconds.

[0177] In this method, the contraction may be maintained for a certain period of time, for example, the maximum possible period of time.

[0178] In this case, the second measuring step may comprise a sub-step in which the contraction period is measured, which may be measured, for example, by the processing unit 8 of the device.

[0179] The contraction period may correspond to the time elapsed between when the measured contraction pressure is 0.76 kPa above the initial pressure measured during the second measurement step (indicating the start of contraction) and when the measured pressure is 0.76 kPa below the initial pressure measured during the second measurement step (indicating the cessation of contraction). A pressure of 0.7 kPa corresponds to the minimum pressure considered a contraction in the scientific literature.

[0180] For example, the second measuring step may include a substep for recording the measured contraction duration, e.g., the substep of recording the contraction duration is performed simultaneously with the substep of recording the measured contraction pressure.

[0181] This recording substep may be carried out by the processing unit 8 of the device.

[0182] According to the first embodiment, the second measuring step may further include a substep of detecting the cessation of contractions exerted by the subject's perineum on the inflatable body and ceasing to record the pressure within the inflatable body and / or the duration of the contractions.

[0183] For example, the cessation of contractions may be detected using measurement data from the first and second measurement means. The determination of the cessation of contractions may be realized by the processing unit 8 of the device.

[0184] For example, the processing unit is configured to detect a recovery of pressure within the inflatable body close to the value of the initial pressure measured, and from that to infer the cessation of contractions exerted by the subject's perineum on the inflatable body.

[0185] According to another embodiment, the second measuring step may further comprise the sub-step of ceasing to record the pressure in the inflatable body and / or the deflation period after a predetermined period of time.

[0186] For example, recording of deflation pressure measurements, or recording of deflation pressure measurements and deflation duration, may be stopped after a predetermined time has elapsed from the start of recording, which may be between 5 and 20 seconds, such as between 10 and 15 seconds, for example 10 seconds.

[0187] In the method of the present invention, multiple deflations, for example short deflations or deflations lasting for a long period of time, may be applied to the inflatable body.

[0188] For example, the second measuring step may be, for example, after the step of stopping recording for the first contraction: - detecting the onset of at least one second contraction exerted on the inflatable body (2) by the subject's perineum and recording the pressure measured by the second measuring means within the inflatable body; - recording the pressure measured by the second measuring means in the inflatable body (2); may include:

[0189] These steps may be performed by the processing unit 8.

[0190] For example, the second measuring step may be, for example, after the step of stopping recording for the second contraction: detecting the onset of a third contraction exerted on the inflatable body by the subject's perineum and recording the pressure measured by the second measuring means within the inflatable body; recording the pressure within the expandable body with a second measuring means; may include:

[0191] These steps may be performed by the processing unit 8.

[0192] The method may include the step of recording, for each contraction, the pressure of the contraction applied as described above, or recording the pressure of the contraction and the duration of the contraction.

[0193] The method may include the step of detecting cessation of a previous contraction before each step of determining a new contraction.

[0194] These steps may be performed by the processing unit 8.

[0195] For example, the time between contractions may be, for example, at least 30 seconds, such as 60 seconds.

[0196] Additionally, the method may include a subsequent second measurement step.

[0197] For example, for each second measuring step, the expandable body inserted at least partially within the subject's reproductive tract may be expanded according to a respective different predetermined dimensional setting.

[0198] For example, the method may include a dimensioning step in which the expandable body may be inflated to a set size, for example, 3 cm diameter, and one or more deflations may be applied, followed by a dimensioning step in which the expandable body may be inflated to a set size, for example, 4 cm diameter, and one or more deflations may be applied, followed by a dimensioning step in which the expandable body may be inflated to a set size, for example, 5 cm diameter, and one or more deflations may be applied.

[0199] For example, the method may include the step of the expandable body being at least partially, eg completely, deflated between each second measuring step.

[0200] Deflation of the inflatable body may be achieved by the processing unit 8 of the device.

[0201] The method according to the invention may, according to an embodiment, further comprise a step in which a value of the perineal strain is calculated or determined from the pressure measured in the inflatable body during the second measuring step. The value of the perineal strain may be calculated or determined by the processing unit 8 of the device.

[0202] For example, the step of calculating the strain value may be performed after the second measuring step.

[0203] For example, the tension value may be calculated or determined from the contraction pressure recorded during the second measurement step.

[0204] For example, the tension value may be calculated or determined from the average value of the pressure values ​​measured and recorded during the second measurement step (e.g., the average value of the pressure values ​​near the highest value measured in the second measurement step).

[0205] Tension values ​​are determined based on the modified Oxford scale assessment technique (see Table 1 below).

[0206] [Table 1]

[0207] The value of this tension (none, very weak, weak, average, good, very good) is estimated based on the range of values ​​that the average recorded pressure value falls within.

[0208] For example, when multiple contractions are applied, the tension value is calculated or determined from the average of the pressures recorded for each contraction (e.g., the average of the pressure values ​​near the highest value measured in the second measurement step).

[0209] For example, the method may include a step in which a signal, for example a visual signal, representing the calculated tension value is emitted, for example by an external device 9, for example a smartphone 900.

[0210] For example, the method may include a step in which a signal, for example a visual signal, representing the calculated strain value is displayed, for example on a display of an external device 9, for example a mobile terminal 900.

[0211] The external device 9, such as the interface 90 or the terminal 900, is thus configured to emit a signal, for example a visual signal, in real time, representing the calculated strain value.

[0212] For example, this signal can be a score between 0.0 and 5.0 representing the calculated Perineal tone value. A score equal to 0 represents a tone value of "none" and a score equal to 5 represents a tone value of "very good." The external device 9, such as the interface 90 or the terminal 900, is thus configured to emit a signal in real time, which signal is a function of the calculated tone value.

[0213] For example, the human-machine interface is configured to emit in real time a first signal, e.g., a visual signal, representing a first calculated tension value or a first range of calculated tension values, and at least one second signal, e.g., a visual signal, different from the first signal, representing a second calculated tension value different from the first calculated tension value or a second range of calculated tension values ​​different from the first range of calculated tension values.

[0214] According to another embodiment, the value of the perineal tension can be calculated from the pressure measured in the inflatable body recorded during the second measurement step, e.g. the pressure of the deflation and the duration of the deflation. The value of the perineal tension can be calculated or determined by the processing unit 8 of the device.

[0215] For example, the step of calculating the strain value may be performed after the second measuring step.

[0216] For example, the tension value may be calculated or determined from the recorded contraction pressure and contraction duration recorded during the second measurement step.

[0217] For example, this value is calculated from the average value of the recorded pressures recorded during the second measurement step (e.g., the average value of the pressure values ​​near the highest value measured in the second measurement step) and the contraction period.

[0218] Tension values ​​are determined based on the modified Oxford scale assessment technique (see Table 2 below).

[0219] [Table 2]

[0220] The value of this tension (none, weak, average, good, very good) is estimated based on the range of values ​​that the average recorded pressure value falls within and the duration of the contraction, i.e., contraction period.

[0221] To calculate or determine a strain value, the applied contraction must meet both the duration and pressure criteria for the corresponding value. For example, a contraction lasting less than 1 second with an average recorded pressure of 1.50 kPa would be scored as 1. Similarly, a contraction lasting 3 seconds with an average recorded pressure of 0.4 kPa would also be scored as 1.

[0222] When multiple contractions, e.g., three contractions, are applied to the inflatable body by the subject, a tension value can be calculated for each contraction based, for example, on the range of values ​​within which the average of the recorded pressure values ​​falls and the duration of that contraction within the group of contractions. In this way, each contraction can be individually evaluated, allowing for detailed analysis by a person using this evaluation. The method can include selecting from the values ​​calculated for the individual contractions, e.g., based on input made by the human-machine interface 90, e.g., by a user selecting a value from values ​​calculated and displayed by the external device 9, and recording, e.g., the selected value. The selecting and recording steps can be performed, for example, by a processing means. Alternatively, or additionally, the tension value can be calculated from the average of the average pressure values ​​of the contractions recorded during the second measurement step and the duration and / or duration of the contractions recorded during the second measurement step.

[0223] For example, the method may include a step in which a signal, for example a visual signal, representing the calculated strain value is displayed, for example on a display of the external device 9, for example on a display of the mobile terminal 900.

[0224] The external device 9, such as the interface 90 or the terminal 900, is thus configured to emit a signal, for example a visual signal, in real time, representing the calculated strain value.

[0225] For example, this signal may be a score between 0.0 and 5.0, representing the calculated Perineal tone value. A score equal to 0 represents a tone value of "none" and a score equal to 5 represents a tone value of "very good." The external device 9, such as the interface 90 or the terminal 900, is thus configured to emit a signal in real time, which signal is a function of the calculated tone value.

[0226] The method may include a step of displaying a first signal, e.g., a visual signal, on a display of a human-machine interface 9, e.g., a mobile terminal 9 (Figure 14), when the perineal strain value is within a first range of perineal strain values, and at least one second signal, e.g., a visual signal, different from the first signal, when the perineal strain value is within a second range of perineal strain values ​​that is greater than the first range of perineal strain values.

[0227] An external device 9, such as an interface 90 or a terminal 900, is thus configured to emit a signal in real time, for example a signal representative of the value of the perineal tone.

[0228] For example, the human-machine interface is configured to emit in real time a first signal, e.g., a visual signal, representing a first calculated tension value or a first range of calculated tension values, and at least one second signal, e.g., a visual signal, different from the first signal, representing a second calculated tension value different from the first calculated tension value or a second range of calculated tension values ​​different from the first range of calculated tension values.

[0229] Furthermore, all or part of the processes described above as being performed, realized and / or executed by the processing unit 8 may be executed by an external device such as the interface 90, e.g., the terminal 900. Thus, the processing unit 8 may be configured to calculate the perineal tension values ​​in real time and to transfer the calculated force values ​​in real time to the external device. The processing unit 8 may also be configured to collect and record measurement data from the pressure measuring means 6 and / or the dimension measuring means 5 and to transfer these to the external device.

Claims

1. 1. A method for monitoring perineal rehabilitation in a subject, comprising: The method comprises performing a measuring step, for example by a processing means (80), In the measuring step, an expandable body (2) at least partially inserted into the subject's reproductive tract is expanded according to a predetermined dimensional setting; The pressure within the inflatable body (2) is measured by a second measuring means (5). method.

2. The method includes performing the measuring steps continuously; the expandable body, at least partially inserted into the subject's reproductive tract, is expanded according to a different predetermined dimensional setting for each of the measuring steps; The method of claim 1.

3. the method comprising performing a step in which the expandable body is at least partially, e.g., completely, deflated between the measuring steps; The method of claim 2.

4. The method comprises: an inflatable body (2) at least partially inserted into the subject's reproductive tract is inflated according to a predetermined pressure setting; The dimensions of the inflatable body (2) are measured by a first measuring means (6), performing a first measuring step; 3. The method according to claim 1 or 2.

5. an external device configured to emit a visual signal in real time representative of the measured dimension; The method of claim 4.

6. Inflating the expandable body in the first measuring step is performed automatically, and / or inflating the expandable body in the second measuring step is performed automatically. The method of claim 4.

7. The method includes a further insertion step in which at least a portion of the expandable body (2) is inserted into the reproductive tract of the subject. The method according to any one of claims 1 to 6.

8. During the insertion step, only a first portion of the expandable body (2) is inserted into the reproductive tract of the subject. The method of claim 7.

9. the first portion of the inflatable body (2) corresponds to half of the inflatable body (2); The method of claim 8.

10. The method includes the first measuring step and the second measuring step, The first measuring step is performed before the second measuring step. The method according to any one of claims 4 to 9.

11. the method comprises, before the second measuring step, a step executed by the processing means (80) of determining the set value of the dimension according to the dimension of the expandable body (2) measured during the first measuring step, The method of claim 10.

12. The second measuring step a sub-step of inflating said expandable body (2) according to predetermined dimensional settings; the sub-step of detecting the onset of a first contraction exerted by the perineum of the subject on the inflatable body (2); and recording the pressure measured within the inflatable body after the substep of detecting the onset of the first deflation. The method according to any one of claims 1 to 11.

13. The second measuring step detecting the onset of at least one second contraction exerted by the perineum of the subject on the inflatable body; and recording the pressure measured within the expandable body after the substep of detecting the onset of the second deflation. The method of claim 12.

14. the onset of the first deflation and / or the onset of the second deflation is detected using data representative of the dimensions of the expandable body (2) and the pressure within the expandable body (2).

14. The method according to claim 12 or 13.

15. The method comprises a step, executed by the processing means (80), of calculating a value of the strain, In the calculating step, a value of perineal tension is calculated using the pressure within the expandable body measured during the second measuring step. The method according to any one of claims 1 to 14.

16. A system (100) intended to monitor the rehabilitation of a subject's perineum, comprising: The system comprises processing means (80) configured to carry out the method according to any one of claims 1-6 and 10-15. system.

17. The system comprises a device intended to monitor the rehabilitation of the perineum of a subject, The device comprises: an inflatable body (2) intended to be at least partially placed within the reproductive tract of the subject; means (4) for inflating and / or deflating said inflatable body (2); first measuring means (6) configured to measure the dimensions of the inflatable body and / or second measuring means (5) configured to measure the pressure within the inflatable body; a processing unit (8) configured to acquire measurement data from the first measurement means and the second measurement means; The processing means (80) comprises the processing unit (8), 17. The system of claim 16.

18. the processing means (80) are adapted to calculate in real time a value of the perineal tension from the measurement data provided by the second measuring means and to transfer said value of tension to an external device (9); and / or the processing means (80) is configured to transfer the measurement data provided by the second measuring means to the external device (9) in real time, the external device being configured to calculate a value of tension in real time from the measurement data transferred by the processing unit.

20. The system of claim 17.

19. the system comprises a human-machine interface (90) in communication with the processing unit (8) of the device, configured to emit in real time a signal, e.g. a visual signal, representative of the value of perineal tension calculated from the measurement data of the second measuring means; A system according to any one of claims 16 to 18.

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

21. The human-machine interface (90) comprises: a first signal, e.g., a visual signal, representing a first calculated strain value or a first range of calculated strain values; and at least one second signal, e.g., a visual signal, different from the first signal, in real time, representing a second calculated tension value different from the first calculated tension value or a second range of calculated tension values ​​different from the first range of calculated tension values.

21. A system (100) according to claim 19 or 20.

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