System for measuring contractions of the pelvic floor muscles of a patient, and method for measuring contractions of the pelvic floor muscles using such a system

Abstract

System (1) for measuring contractions of the pelvic floor muscles (MPP) of a patient, the system comprising: - A pelvic floor muscle probe configured to be positioned within an internal canal of the patient, - A data processing module (4) configured to compare a difference, denoted ΔT, between a pressure measurement time Tp and a position measurement time Tm and to compare the difference ΔT against a determined threshold value; in which the data processing module (4) is in communication with a notification device (5) for notifying the patient that, when the difference between the pressure measurement time Tp and the position measurement time Tm is less than or equal to the threshold value, the synergy between the movement of the body and the contraction of the pelvic floor muscles is suboptimal.

Description

DESCRIPTION Title: System for measuring pelvic floor muscle contractions performed on a patient and method for measuring pelvic floor muscle contractions using such a system FIELD OF INVENTION

[0001] The present invention relates to a system for performing exercises to strengthen the pelvic floor muscles of a patient.

[0002] More specifically, the invention relates to such a system for monitoring whether Kegel exercises are being performed correctly by the patient. TECHNOLOGICAL BACKGROUND

[0003] The pelvic floor muscles (PFM) are a group of muscles that extend from the coccyx to the pubic bone and, when contracted, support the internal pelvic organs (including the bladder, rectum, and anus) to ensure the closure of the anal and bladder sphincters and maintain continence. They therefore play an important role in the control of urine and stool. The pelvic floor muscles also play an important role in sexual function.

[0004] However, following pregnancy, childbirth, trauma, or simply with age, the pelvic floor muscles can weaken, impacting the patient's comfort and health. Several pathological conditions, such as cystocele (protrusion of part of the bladder through the vaginal wall), urinary incontinence, rectocele (protrusion of part of the rectum into the vagina), uterine prolapse (exteriorization of the uterus into the vagina), and bladder and sexual dysfunctions, can be caused by weakened pelvic floor muscles.

[0005] Therefore, exercises and instruments have been developed to strengthen the pelvic floor muscles. These exercises generally consist of a series of contractions and relaxations of these muscles, performed consciously by the patient, possibly with the help of a healthcare professional, and which help strengthen the pelvic floor muscles. These exercises are commonly called Kegel exercises. However, performing such exercises without monitoring their impact on the pelvic floor muscles is insufficient. Indeed, it is necessary to determine whether an exercise is being performed correctly, that is, to verify whether the muscle or group of muscles targeted by the exercise is being properly engaged, otherwise there is a risk of injury. not only fail to achieve the desired strengthening, but also further damage the pelvic floor muscles.

[0006] To ensure Kegel exercises are performed correctly, they are generally carried out under the supervision of a healthcare professional, who manually and / or visually determines whether the pelvic floor muscles are contracting properly, based on instructions they may provide. However, manual supervision can be incomplete. Furthermore, professional intervention makes these exercises difficult to perform frequently and regularly over the long term, and may also cause discomfort for the patient.

[0007] Therefore, there are devices that allow us to monitor Kegel exercises and detect when they are performed incorrectly, either by a professional or by the patient themselves at home.

[0008] The general principle of these devices is to detect pelvic floor muscle contractions by measuring, via a probe inserted into an internal canal (vaginal canal or anus) of the patient, the muscle activity or pressure generated by the pelvic floor muscles, and to verify that the timing of the contraction corresponds to the instructions given for the exercise. The intensity of the contractions can also be measured. Visualizing the contractions then allows the patient and / or the healthcare professional to assess the quality of the contractions.

[0009] Document CN110538432 describes an example of such a device for measuring pelvic floor muscle pressure in both a relaxed and a contracted state. By comparing the pressure values ​​in these two states, it becomes possible to assess the level of pelvic floor muscle contraction.

[0010] Document W02017 / 118461 describes an example of a device with a display system for visualizing contractions. Such a system includes pressure sensors that measure the pressure exerted on the device, and a device for visually translating these measurements as deformations of the device.

[0011] It is also known to propose visualizing contractions using a video game-like display, in which pelvic floor muscle contractions control interactions or behaviors within the game, for example, on a smartphone. Document WO2021 / 144270 describes an example of such a display.

[0012] During a pelvic floor muscle strengthening exercise, contractions of muscles other than the pelvic floor muscles occur, consciously or unconsciously. can occur. In this case, it involves the abdominal muscles, causing an increase in intra-abdominal pressure which in turn increases the pressure exerted on the pelvic floor.

[0013] Document WO2021 / 144270 proposes measuring two distinct pressures in the vaginal canal at two different depths within the patient's internal canal: one pressure in the midline and one pressure in the distal end. Comparing these two measurements at different depths allows for the determination of whether and to what extent abdominal pressure has been increased, thus indicating whether the pelvic floor muscle strengthening exercise was performed correctly. This additional information improves the evaluation of pelvic floor muscle strengthening exercises and enables the implementation of appropriate corrective measures.

[0014] Alternatively, it is known to detect improper contraction during pelvic floor muscle strengthening exercises by tracking the movements of a device. Document WO2016 / 119002, for example, proposes using a gyroscope, possibly combined with an accelerometer, in an intravaginal device to determine whether the muscle movement during an exercise is indeed an up-and-down motion. More specifically, the intravaginal device indicates the probe's orientation relative to a vertical reference direction within the vaginal canal to determine if the movement is correct. Data on the patient's position can also be used to categorize the results.

[0015] However, in real-life situations, pelvic floor muscle dysfunction can occur during patient movements, such as moving from a sitting to a standing position, and vice versa. Indeed, a patient's movements can put strain on the pelvic floor and cause discomfort, such as urinary or fecal incontinence, especially if the pelvic floor muscles are not functioning properly.

[0016] There is therefore a need for a new system to measure pelvic floor muscle contractions which allows, during exercise, verification of the effectiveness of pelvic floor muscle contractions during movement, in order to better assist the patient in performing pelvic floor muscle strengthening exercises.

[0017] A first object of the invention is to improve the quality of exercises for strengthening the pelvic floor muscles.

[0018] A second object of the invention is to correlate the movements of a patient with the contractions of the pelvic floor muscles.

[0019] A third object of the invention is to facilitate the performance of pelvic floor muscle strengthening exercises by the patient himself, without the help of a healthcare professional.

[0020] A fourth object of the invention is to ensure the patient's comfort during pelvic floor muscle strengthening exercises.

[0021] A fifth object of the invention is to facilitate the evaluation of the quality of pelvic floor muscle strengthening exercises.

[0022] SUMMARY OF THE INVENTION

[0023] Thus, according to a first aspect, the invention relates to a system for measuring pelvic floor muscle contractions performed on a patient. The system includes, in particular: a pelvic floor muscle probe configured to be positioned inside an internal canal, such as the vaginal canal or the anus and rectum, of the patient and in contact with the internal surface of said canal. The probe comprises a body, an external surface, at least one pressure sensor adapted to measure the pressure applied by the internal surface of the canal on the external surface of the probe, and at least one motion sensor adapted to detect and / or measure movement of the probe in a reference frame external to the probe; and a pressure measurement module configured to calculate at least one differential pressure, denoted AP, in the patient's internal canal from a pressure measurement.The differential pressure (AP) uses as a reference pressure values ​​measured in a relaxed state of the patient, in which the pelvic floor muscles are relaxed. The measurement module is configured to associate at least one AP differential pressure measurement with a pressure measurement time (Tp). Specifically, when the pressure measurement can be interpreted as a contraction of the pelvic floor muscles, the measurement module can associate a first time (Tp1) with the initiation of a contraction and a second time (Tp2) with the end of the same contraction. A motion measurement module is configured to detect at least one movement of the patient's body from a probe movement measurement and to associate the detected movement with at least one measurement time (Tm).In particular, when the movement measurement can be interpreted as a set of movements of the given patient's body, the measurement module can associate a first time Tm1 with the beginning of a set of movements and a second time Tm2 with the end of the same set of movements; A data processing module communicates with the pressure measurement module and the motion measurement module. The data processing module is configured to calculate a difference, denoted AT, between the pressure measurement time Tp and the motion measurement time Tm. The data processing module is further configured to verify that the difference AT meets a predetermined condition.

[0024] The data processing module is in communication with a notification device to notify the patient that, when the difference AT between the pressure measurement time Tp and the position measurement time Tm violates, i.e. does not respect, the determined condition to be respected, the synergy between the contractions of the abdominal muscles and the pelvic floor muscles is sub-optimal.

[0025] The condition should be understood here as any rule allowing the time Tp of pressure measurement to be compared with the time Tm of movement measurement, in order to verify the correct execution of a pelvic floor muscle strengthening exercise.

[0026] Thanks to these features, the system allows for the correlation of the patient's body movements—for example, when moving from a standing to a sitting position, or when walking or running—with the contractions of the pelvic floor muscles. Specifically, the use of a reference point external to the patient and the probe provides dynamic information, that is, information about the movements performed by the patient's body. By incorporating the monitoring of this correlation into the tracking of pelvic floor muscle strengthening exercises, the quality of the results obtained for pelvic floor muscle problems is improved. For example, the system can verify that the muscle contraction during the period defined by Tp1 and Tp2 is maintained throughout the entire set of movements performed during the period defined by Tm1 and Tm2.

[0027] In addition, by placing the motion sensor in the probe, the patient has a single device to insert and handle, limiting discomfort and facilitating use by the patient alone.

[0028] Depending on various aspects, it is possible to predict one and / or the other of the characteristics below taken alone or in combination.

[0029] According to one embodiment, the motion sensor can include at least one accelerometer that measures the probe's acceleration relative to gravitational acceleration. The motion measurement module can then be configured to detect movement of the body as a whole, in a frame of reference external to the probe and to the patient, when the measured acceleration is greater than or equal to a determined value.

[0030] Thus, the accelerometer can easily be small enough to be integrated into the probe, is readily available on the market, offers suitable measurement accuracy and limits costs.

[0031] In one embodiment, the probe can comprise at least two pressure sensors operating independently of each other, with distinct and non-overlapping detection zones. The processing module can thus measure a differential pressure in each detection zone.

[0032] The differential pressure difference in the two detection zones provides additional information on the quality of contractions during the performance of a pelvic floor muscle strengthening exercise and allows the patient to be guided to improve the performance of the exercise.

[0033] According to one embodiment, the processing module can be configured to calculate a first difference AT1 between a first pressure measurement time Tp1 and a first motion measurement time Tm1. A first condition to be met is that the first difference AT1 is contained within a predetermined time interval.

[0034] The term interval should be understood here as having at least one defined limit, the other limit being undefined, that is to say equal to plus or minus infinity.

[0035] Similarly, the processing module can be configured to calculate a second difference AT2 between a second pressure measurement time Tp2, following the first pressure measurement time Tp1, and a second motion measurement time Tm2, ​​following the first motion measurement time Tm1. A second condition to be met is that the second difference AT2 must fall within a specified time interval.

[0036] By configuring the pressure module so that the first pressure measurement time Tp1 corresponds to the initiation of a contraction and the second pressure measurement time Tp2 to the end of that contraction, and by configuring the movement module so that the first movement measurement time Tm1 corresponds to the beginning of a set of movements and the second movement measurement time Tm2 to the end of that set of movements, the system can detect whether a contraction is maintained throughout the set of movements. If the first and / or second condition is violated, the notification device can alert the patient that the synergy between abdominal and pelvic floor muscle contractions is suboptimal.

[0037] According to one embodiment, the probe may comprise a first section intended to be placed in a proximal area of ​​the patient's internal canal and a second section intended to be placed in a distal area of ​​the internal canal when the probe is inserted. The motion sensor can thus be housed in the second section of the probe, so that one measurement axis corresponds to the axis of a distal area of ​​the internal canal.

[0038] Thus, the movement detection reference frame closely corresponds to the patient's natural reference frame, namely up / down, front / back, and left / right. This facilitates the interpretation of the movement detection data.

[0039] In this case, the first section may include at least one first pressure sensor adapted to measure the pressure applied by the patient's channel on the external surface of the probe body in a proximal area of ​​the channel and the second section may include at least one second pressure sensor adapted to measure the pressure applied by the patient's channel on the external surface of the probe body in a distal area of ​​the channel.

[0040] It is therefore possible, by comparing the two differential pressures from the measurements by each pressure sensor, to detect a contraction of the intra-abdominal muscles which is unfavorable to the performance of a good exercise to strengthen the pelvic floor muscles, and to warn the patient.

[0041] In one embodiment, the probe can be elastically flexible, allowing it to assume a first position, called the initial position, in which the first section is inclined relative to the second section at a predetermined angle of inclination, called the rest position, and a second position, called the curved position, in which the angle of inclination deviates from the rest value due to its flexibility. For example, the value of the angle of inclination at rest is approximately 162°, and the value of the angle of inclination when the probe is in the curved position deviates from the rest value by a maximum of plus or minus 30°.

[0042] The probe can thus follow any movements of the internal canal during the exercises, limiting patient discomfort.

[0043] According to one embodiment, the notification device may include an interface for visually displaying data concerning contractions performed by the patient.

[0044] This allows the patient easy access to information about the exercises performed, preferably during the exercise itself, so they can correct their own form. This data is displayed, for example, in the form of a video game, making it easily accessible to the patient.

[0045] According to a second object, the invention provides a method for measuring pelvic floor muscle contractions (PFM) using a system as described above, the method comprising the following steps: calculating at least one differential pressure in the patient's canal, denoted AP, the differential pressure having as a reference pressure values ​​measured in a relaxed state of the patient in which the pelvic floor muscles are relaxed, and associating a measured differential pressure AP with a pressure measurement time Tp. In particular, when the pressure measurement is interpreted as a pelvic floor muscle contraction, a first time Tp1 can be associated with the initiation of the contraction and a second time Tp2 can be associated with the end of the contraction; detecting a movement of the patient's body from a measurement of the probe's movement and associating the detected movement with a measurement time Tm.In particular, when the movement measurement is interpreted as a movement of the patient's body, the measurement module associates a time Tm1 with the start of the movement and a time Tm2 with the end of the movement; calculate a difference AT between the pressure measurement time Tp and the position measurement time Tm and compare the difference AT with a determined condition; notify the patient that, when the difference between the pressure measurement time Tp and the position measurement time Tm violates, i.e., does not respect, the determined condition, the synergy between the contractions of the abdominal muscles and the pelvic floor muscles is suboptimal. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Embodiments of the invention will be described below with reference to the drawings, briefly described below:

[0048] [Fig. 1] represents a diagram illustrating a system for measuring contractions of the pelvic floor muscles according to an embodiment according to the invention;

[0049] [Fig. 2] represents a schematic three-dimensional view of one embodiment of a pelvic floor muscle probe for the system of Figure 1;

[0050] [Fig3a] and [Fig.3b] each represent a schematic example of curves obtained using the measurement system in Figure 1.

[0051] In the drawings, identical references designate identical or similar objects. DETAILED DESCRIPTION

[0052] Figure 1 schematically represents a system 1 for measuring pelvic floor muscle contractions, also denoted PFM. More specifically, such a system 1 can be used to track the performance of Kegel exercises, which strengthen the pelvic floor muscles, for personal use at home or with the assistance of a healthcare professional.

[0053] Such a system 1 includes in particular a probe 100, illustrated more precisely in figure 2. The probe 100 is intended to be inserted at least partially into an internal canal, and in particular the vaginal canal or the anus of a patient.

[0054] The following section focuses specifically on the case where the internal channel is the vaginal canal. However, the system described is also suitable for inserting the probe, for example, into the anus and rectum.

[0055] The probe 100 comprises a body 101 extending substantially in a longitudinal direction between a proximal end 102 and a distal end 103.

[0056] The adjectives "distal" and "proximal" are taken here in reference to the position of the 100 probe when inserted into the patient's internal canal, distal being towards the introitus and proximal being towards the cervix.

[0057] The body 101 includes an external surface 104, enveloping the body 101, made of biocompatible material, adapted to the anatomy of the human body so that it can be inserted into the vaginal canal, and made of liquid-proof material.

[0058] According to the embodiment illustrated in Figure 2, the body 101 of the probe 100 comprises three sections. A first section 105, substantially oblong in the shape of a ball, extends from the proximal end 102 and is separated from a second section 106 in the shape of an oblong ball also by a third section 107 of constriction, that is to say of diameter less than that of the first section 105 and the second section 106. The first section 105 and the second section 106 are substantially symmetrical of revolution, but not necessarily.

[0059] The probe 100 further includes a portion 108, referred to as the caudal portion, extending the second section 106 in the longitudinal direction. More specifically, the caudal portion 108 comprises a connecting section 109 attached to the second section 106, to the proximal end 103, and a substantially wire-shaped gripping section 110 extending to a free end 111, intended to be grasped by the patient. The connecting section 109 ensures continuity of shape between the second section 106 and the shaped section 110. The first portion 105 and the second portion 106 are intended to be inserted into the vaginal canal. The caudal portion 108 is intended to be partially inserted into the patient's vaginal canal, with at least part of the gripping section 110 remaining outside.Therefore, the caudal portion 108 is also covered, at least over a portion corresponding to that which will be inserted into the vaginal canal, and preferably over its entire surface, with an external surface 112 made of biocompatible material, adapted to the anatomy of the human body for insertion into the vaginal canal, and of a liquid-tight material. The caudal portion 108 may be continuous with the body 101. For example, the external surface 104 of the body 101 is continuous with the external surface 112 of the caudal portion 108, so that there is no surface discontinuity. Alternatively, the caudal portion 108 may be attached to the body 101, for example, assembled at the distal end 103 by any suitable means.

[0060] Thus, in other words, sections 105 and 106 form two successive bulbs, the overall undulating shape of probe 100 facilitating insertion into the patient's internal canal while minimizing discomfort once the probe is in place. The caudal section 108, and more specifically the grip portion 111, remains at least partially accessible outside the canal to facilitate the removal of probe 100 from the vaginal canal. Preferably, the caudal section 108 is at least partially, and preferably at least in the grip portion 111, flexible, meaning it deforms without breaking when manually manipulated by a user. When probe 100 is inserted into the vaginal canal, the caudal section 108 is thus easily positioned so as not to interfere with the patient's performance of the exercises.The external surface 104 encloses at least the first section 105 and the second section 106, so that the probe 100. is in contact with the internal wall of the vaginal canal at least by a portion of the external surface 104 around the first section 105 and the second section 106.

[0061] The length L of the body 101 can be defined as the sum of the length L1 of the distal section 106 and the length L2 of the proximal section 105. More precisely, the length L1 is, for example, measured between the distal end 102 and the center of the constricted section 107, and the length L2 is, for example, measured between the center of the constricted section 107 and the proximal end 103. In one embodiment, the length L of the body 101 of the probe 100 is approximately 66 mm (millimeters), so as to correspond on average to two-thirds of the length of the vaginal canal of a human patient. In practice, the probe 100 is sized so that the length of the inserted portion, which may include part of the caudal portion 108, in the vaginal canal corresponds to approximately 66 mm.Thus, the proximal end 102 of the probe 100 remains, from the opening of the vaginal canal, within the first two-thirds of the vaginal canal length, away from the last third of the vaginal canal length where the cervix is ​​located, and which is therefore a sensitive area. Patient comfort is thus ensured.

[0062] In one embodiment, the body 101 of the probe 100 is elastically flexible, meaning that it can deform without breaking under stress and return to its original shape when stress is removed. For example, the body 101 is flexible at least at the first constriction section 107, so that the first section 105 can be inclined relative to the second section 106. Thus, the probe 100 can assume a first position, called the initial position, corresponding to the position in the absence of stress, and a curved position. The initial position can correspond to an inclination between the first section 105 and the second section 106 at an angle α of a predetermined value, called the resting angle, adapted to human anatomy. For example, when probe 100 is intended to be inserted into a patient's vaginal canal, it has been determined that a rest angle of 162° is anatomically suitable.This angle α is measured between an extension axis A of the first portion 105, which is, for example, the axis of revolution, and an extension axis B of the second portion 106, which is again, for example, the axis of revolution. In order to correspond to the anatomy of the human body, the flexibility of the probe body 101 allows the angle α of inclination, when the probe 100 assumes a curved position, to vary by plus or minus 30° relative to the value at rest.

[0063] Due to its shape, the 100 probe, when inserted into the vaginal canal, closely follows the curvature of the vaginal canal, possibly using its flexibility properties, facilitating insertion and limiting discomfort for the patient.

[0064] The probe 100 includes at least one pressure sensor 113, which allows the pressure applied by the internal surface of the vaginal canal to be measured on the external surface 104 of the probe 100.

[0065] A pressure sensor here refers to any sensor or set of sensors that can collect information about pressure.

[0066] Preferably, the probe may include two pressure sensors, namely a first sensor housed in the first section 105 and a second sensor housed in the second section 106. The two sensors operate independently of each other; that is, the measurement taken by one is not influenced by the measurement taken by the other. Their detection zones are distinct and do not overlap; that is, each sensor measures the pressure exerted by a muscle or group of muscles on the probe that is different and distinct from the muscle or group of muscles exerting pressure on the second sensor. Each sensor thus measures the pressure of a distinct area of ​​the vaginal canal.Due to the positioning of the first section 105 and the second section 106, one sensor placed in the first section 105 is designed to measure the pressure exerted on the probe 100 in a so-called proximal zone of the vaginal canal, and the other sensor placed in the second section 106 is designed to measure the pressure exerted on the probe 100 in a so-called distal zone of the vaginal canal. The presence of the first constriction zone 107 contributes to the decoupling and separation of the measurements taken by the two sensors.

[0067] The 100 probe thus conforms to the probe described in the aforementioned document WO2021 / 144270. More specifically, by considering a reference pressure measured in a relaxed state of the patient, when the pelvic floor muscles are in a relaxed or slack state, it allows for the measurement of two so-called differential pressures. A comparison between these two differential pressures makes it possible, in particular, to detect contractions considered "bad." More precisely, it detects an increase in intra-abdominal pressure.

[0068] Indeed, contractions of the abdominal muscles can occur during pelvic floor exercises. Contraction of the abdominal muscles beyond a certain point may indicate that the pelvic floor exercise is not being performed correctly. Furthermore, contraction of the abdominal muscles can lead to increased intra-abdominal pressure.

[0069] To this end, the measurement system 1 includes a pressure measurement module 2 which is in communication with at least one sensor 113, and in practice with both pressure sensors of the probe in order to collect their measurements. In a As a preliminary step, the pressure measurement module 2 records at least one reference value, allowing it to calculate at least one differential pressure, denoted AP, at any given time. This differential pressure is then compared with a pressure threshold value to determine if the contractions are sufficient for the exercise being performed. In the case of two pressure sensors, the pressure measurement module 2 can calculate two differential pressures, denoted AP1 and AP2, each of which can be compared with a pressure threshold value, and which can then be compared to each other to detect any excessive increase in intra-abdominal pressure.

[0070] The pressure threshold value(s) used can be fixed, pre-recorded in the pressure measurement module 2, or customized, determined for example by a calibration step during implementation of the probe 100 on the patient and then recorded in the pressure measurement module 2.

[0071] The measurement module 2 can be integrated into the probe 100 or be remote, the pressure measurement data from the sensors being transmitted to the pressure measurement module 2 by a suitable transmission system, wired or wireless, or comprise a part integrated into the probe 2 and a remote part.

[0072] The probe 100 includes at least one motion sensor 114, which detects and / or measures movement of the probe 100 in a reference frame external to the probe 100 and external to the patient. The motion sensor 114 thus functions to detect and / or measure movements of the patient's body in this external reference frame when the probe 100 is inserted into the patient's vaginal canal. The movements detected and / or measured by the motion sensor 114 correspond not to internal muscle contractions of the patient, but rather to a displacement of all or part of the patient's body in the external reference frame. A movement must therefore be understood in a dynamic sense, for example, as a temporal succession of positions of the patient's body in the external reference frame.

[0073] The motion sensor 114 includes, for example, at least one accelerometer, which measures the acceleration of probe 100 relative to gravitational acceleration in three dimensions, that is, in a three-dimensional orthogonal frame of reference. Motion is recorded by the motion sensor 114 as a translation vector in the external frame of reference. As before, the term "motion sensor" here refers to a single sensor or a set of sensors capable of detecting motion and / or providing a measurement of that motion.

[0074] The motion sensor 114 is placed, for example, in the first section 105 or the second section 106 of the probe 100, each of which offers sufficient volume to accommodate it. In theory, however, the motion sensor 114 can be placed anywhere within the probe 100. In one embodiment, the sensor 114, when it includes an accelerometer, is placed in the distal section 106 of the probe body 101. Thus, one measurement axis of the accelerometer is aligned with the distal area of ​​the vaginal canal, a second measurement axis corresponds substantially to the left / right axis of the patient, and the third measurement axis corresponds substantially to the front / back axis of the patient's body. This facilitates the reading of the motion detection, thereby also simplifying adjustments for the patient.

[0075] By placing the motion sensor 114 in the body 101 of the probe 100 with the pressure sensors 113, it is not necessary to multiply the devices on the patient, the probe 100 including all the required instruments, limiting discomfort for the patient.

[0076] System 1 includes a motion measurement module 3, which communicates with the motion sensor 114 to detect movement of the patient's body. Specifically, the motion measurement module 3 receives the measurement from the motion sensor 114. This measurement can correspond to a detection signal, such as 0 in the absence of movement or 1 in the presence of movement, so that the motion measurement module 3 detects any movement of the patient indiscriminately. Alternatively, the movement measurement by the sensor 114 can correspond to a value dependent on the amplitude and / or direction of the movement. In this case, the motion measurement module 3 receives the measurement from the motion sensor 114 and compares it with a motion threshold value to determine whether the movement measurement has reached a sufficient value to consider it a significant movement.The motion threshold value can be fixed and pre-recorded in the motion measurement module 3. It can also be customized, determined through a calibration step based on one or more specific exercises performed by the patient while the 100 probe is inserted into the vaginal canal, and then recorded in the motion measurement module 3. The motion threshold value can also depend on the intended exercise, so several threshold values ​​are recorded and / or determined through calibration, and then the threshold value is selected for a given exercise. Thus, when the motion measurement module 3 determines that the measured movement is greater than or equal to the corresponding motion threshold value, it considers movement to be detected. Alternatively, or... In combination, the measurement of the movement by the motion sensor 114 can be recorded by the measurement module 3.

[0077] The detected movement is preferably a translation in the frame of reference external to the patient.

[0078] For example, the motion module 3 can detect a translation mainly along a vertical axis in the reference frame external to the probe and the patient, indicating a movement such as moving from a sitting to a standing position and vice versa, or a translation mainly along a horizontal axis in the reference frame external to the probe and the patient, indicating a movement such as walking, running, etc.

[0079] System 1 links pelvic floor muscle contractions to patient movements, integrating the dynamic concept of movement into pelvic floor muscle strengthening exercises and improving exercise quality. To this end, pressure measurement module 2 is configured to associate a time Tp with each differential pressure (AP) measurement that exceeds a threshold value. Similarly, movement measurement module 3 is configured to associate a time Tm with each detected movement. System 1 includes a data processing module 4, which communicates with both pressure measurement module 2 and movement measurement module 3. Data processing module 4 is configured to receive the Tp and Tm time data from modules 2 and 3 and to calculate the difference AT between these two times.The AT difference is then compared with a specific time condition to verify that the contraction and movement occur close enough together to validate the exercise. Thus, the condition applied to the AT difference can arise from various situations depending on the patient's needs. For example, the condition might require that AT not exceed or fall below a threshold value, as will be explained later. AT can be expressed as the absolute value of the difference between Tp and Tm.

[0080] Indeed, studies have shown that it is beneficial to consider the patient's movements during pelvic floor muscle strengthening exercises to verify the simultaneity between the contraction of certain pelvic floor muscles and the execution of a movement. In the case of female anatomy, synergy—that is, the temporal coincidence of contractions—of the pelvic floor muscles and the transverse abdominis muscle, for example, is observed more significantly in women who do not They do not present symptoms of urinary incontinence, unlike women who do have it.

[0081] The condition for the AT difference can be fixed and pre-recorded in a memory location on device 1, linked to the data processing module 4. Alternatively, the condition can be customized, determined through a calibration step based on specific exercises performed by the patient with the probe, and then recorded in the data processing module 4. It can also depend on the targeted pelvic floor muscle strengthening exercise. Thus, several conditions for the AT difference can be pre-recorded or determined through calibration.

[0082] For example, when the AT difference is greater than or equal to a time threshold value, system 1 may consider that the exercise is not being performed correctly, with the pelvic floor muscles contracting too early or too late relative to the time of the movement.

[0083] The system can also determine that, for a given movement, the contraction profile does not correspond to an expected profile, for example when the maximum level of contraction is reached at a time that does not coincide with the expected time when performing a movement.

[0084] System 1 can also detect a relaxation of the pelvic floor muscles during a movement, even when the movement is not fully completed.

[0085] The data processing module 4 then communicates with a notification device 5 to inform the patient that when the difference between the pressure measurement time Tp and the position measurement time Tm exceeds the predetermined condition, the synergy between abdominal and pelvic floor muscle contractions is suboptimal. The notification device 5 may, for example, include an interface to visually display data about the contractions performed to the patient and / or a healthcare professional. This could be, for example, a personal device such as a smartphone. Preferably, the notifications are displayed in real time, during the exercise(s).

[0086] The probe 100 may also include a translation sensor to measure the position of the probe 100 relative to the patient, along the axis of the vaginal canal which serves as a reference. In practice, when the motion sensor 114 includes an accelerometer, this same accelerometer can act as a translation sensor. System 1 may then also include an alert module, which receives the position measurements from the translation sensor and can calculate a difference AL is the difference between the position of probe 100 along the reference axis and a reference position along the reference curve. The alert module is, for example, a sub-module of the movement measurement module 3. An alert signal can then be generated, for example by the data processing module 4, when the AL difference in position reaches an alert threshold value. The signal can be transmitted to interface 5 to warn the patient that probe 100 has moved abnormally. This alert is particularly useful for notifying the patient and / or healthcare professional when probe 100 has moved in such a way as to exit the vaginal canal.

[0087] Each module 2, 3, and 4 can be fully or partially integrated into the probe 100. They can be physically separate from one another, or conversely, be part of the same computer system that performs all the functions described here. Each module 2, 3, and 4 can also be combined, fully or partially, with another module.

[0088] System 1 can thus be used to detect any potential problems in the synergy between body movement and pelvic floor muscle contraction. It can also be used to implement exercises designed to improve this synergy. In particular, the notification device 5 can be used to display an assessment of this synergy through a video game. For example, a character in a video game is controlled by the synergy, making the exercises fun and engaging for the patient.

[0089] More specifically, starting from a given exercise start time, the movement measurement module 3 can record multiple movement measurements at regular intervals and associate each measurement with a time Tm to describe a set of patient movements. Indeed, from these movement measurements, the processing module 4 can recognize a pattern stored in the device's memory that corresponds to a type of exercise, for example, a squat or a series of squats, walking or running, sitting down or standing up from a chair, etc. Simultaneously, starting from the same exercise start time, the pressure measurement module 2 can record multiple differential AP pressures at regular intervals when these exceed a threshold value and associate each with a time Tp.The processing module 4 can then compare the time-domain movement data and the time-domain pressure data over a set of patient movements.

[0090] According to a first embodiment, the processing module 4 can identify a time Tpmax for which the maximum differential AP pressure measurement is taken and compare this time Tpmax with a time Tme corresponding to a predetermined movement for the planned exercise. For example, the time Tme can corresponds to the movement time in which a translation along a vertical axis in the frame of reference external to the patient reaches a particular value. According to this example, the processing module 4 can choose the condition on the difference AT as expressed from a threshold value a in the following way: AT = |Tpmax — Tme| < a

[0091] According to a second example, the processing module 4 can identify a first time Tp1, marking the initiation of a contraction, as the first occurrence, from the start time, of a differential AP pressure measurement exceeding an associated threshold value, and a second time Tp2, marking the end of the same contraction, as the first subsequent occurrence of a differential AP pressure measurement below the threshold value. The contraction is then considered to be sustained between these two times, Tp1 and Tp2. Similarly, the processing module 4 can identify a first time Tm1, marking the beginning of a movement set, and a second time Tm2, ​​marking the end of the same movement set, based on the recorded patterns. System 1 can thus verify that the contraction between Tp1 and Tp2 is maintained at least for the entire duration of the movement set, that is, over the entire period between Tm1 and Tm2.

[0092] For example, to obtain this verification, the processing module 4 can then express two conditions to be met based on four threshold values ​​a11, a12, a21, a22 in the following way: A first condition: a11 < ATI = Tpi - Tml < a12, with a11 negative and a12 positive or zero A second condition: a21 < AT2 = Tp2 - Tm2 < a22, with a21 negative or zero and a22 positive

[0093] If either or both of these conditions are violated, then data processing module 4 sends information to notification device 5 to inform the patient that the exercise was not performed correctly: either the contraction of the pelvic floor muscles started too late, or it was released too early, or both. Data processing module 4 can distinguish between these situations.

[0094] Preferably, for a pelvic floor muscle strengthening exercise, it is acceptable for pelvic floor muscle contraction to be initiated well in advance of the start of movement, whereas the acceptable delay if it is initiated after the start of movement is comparatively very short, or even zero. Thus, for example, the threshold value a11 above may be several seconds, while the threshold value a12 may be on the order of microseconds, or even zero. Similarly, it is It is acceptable for the pelvic floor muscles to release their contractions well after the end of the movement, whereas the acceptable time if they are released before the end of the movement is comparatively very short, or even zero. Thus, for example, the threshold value a22 above can be several seconds, while the threshold value a21 can be on the order of microseconds, or even zero.

[0095] According to a particular embodiment, a11 may be undefined, and a12 may be zero. The first condition expressed above can then be written as:

[0096] ATI = Tpi - Tml < 0

[0097] Similarly, a21 may be zero and a22 may be undefined, so the second condition expressed above can be written:

[0098] 0 < AT2 = Tp2 - Tm2

[0099] An illustrative example will now be presented using figures 3a and 3b, in which the condition to be respected is that of the second example above: the contraction is maintained for the entire duration of the set of movements.

[0100] The patient is asked to perform an exercise in which they carry out a series of body movements, such as a squat. This exercise involves a specific pattern in the patient's body movement measurements, which is unique to them and can be identified, for example, by data processing module 4. Throughout the movement sequence, the patient is expected to contract their pelvic floor muscles, a process measured by pressure module 2.

[0101] Figures 3a and 3b schematically represent curve C, corresponding to the signal from the pressure measurement module 2 as a function of time, and curve D, corresponding to the signal from the movement measurement module 3 as a function of time. The exercise is identifiable by its pattern on the period E of curve D. The movement measurement module 3 associates a time Tm1 with the beginning of the set of movements and a time Tm2 with the end of the same set of movements, which frame portion E of curve D. Similarly, the pressure measurement module 2 associates a time Tp1 with the initiation of pelvic floor muscle contraction and a time Tp2 with the end of pelvic floor muscle contraction, which frame a period F on curve C, corresponding to a pelvic floor muscle contraction. The data processing module 4 can then compare Tm1, Tm2, ​​Tp1 and Tp2.

[0102] In the example of Figure 3a, Tp1 is less than or equal to Tm1 and Tm2 is less than or equal to Tp2, validating the exercise: throughout the duration of the body movement exerting pressure on the pelvic floor, a contraction The pelvic floor muscles are maintained to counteract this pressure and protect them. There is no time interval between Tm1 and Tm2 that is not also between Tp1 and Tp2.

[0103] In the example of Figure 3b, Tp1 is less than or equal to Tm1 but Tm2 is strictly greater than Tp2, the difference between Tm2 and Tp2 being greater than a threshold value, invalidating the exercise: there is a non-zero time interval between Tm1 and Tm2 which is not between Tp1 and Tp2, a contraction of the pelvic floor muscles is not maintained for the entire duration of the movement of the body exerting pressure on the pelvic floor.

[0104] One purpose of measurement system 1 may be to verify that the contraction of the pelvic floor muscles is maintained throughout the entire duration of the body movement, that is, throughout the exercise. In other words, system 1 seeks to verify that the pressure exerted by the pelvic floor muscles on probe 100 is maintained throughout the exercise.

[0105] An exercise will be considered incorrect when the contraction of the pelvic floor muscles is not maintained for the entire duration of the exercise, for example in the following cases: The contraction occurs before the start of the movement set, but it is not maintained throughout the exercise. In this case, the movement module 4 can detect that the time Tm1 of the measurement initiation of the movement set, beginning of period E, is indeed greater than or equal to the time Tp1 of the measurement initiation of the pressure increase, characteristic of a contraction of the pelvic floor muscles, beginning of period F, but that the time Tm2 of the measurement ending of the same movement set, end of period E, is strictly greater than the time Tp2 of the measurement ending of the contraction of the pelvic floor muscles, end of period F. The contraction occurs after the start of the movement sequence. In this case, the movement module 4 can detect that the time Tm1 of the movement initiation measurement, beginning of period E, is strictly less than the time Tp1 of the initiation measurement of the pressure increase, characteristic of a contraction of the pelvic floor muscles, beginning of period F. No contraction occurs. In this case, neither pressure measurement time Tp1 nor Tp2 is taken into account by processing module 4. Therefore, there is a time interval between Tm1 and Tm2 during which no pelvic floor muscle contractions occur, which is not included between Tp1 and Tp2, since Tp1 and Tp2 do not exist.

[0106] Conversely, an exercise will be considered correctly performed when a contraction is executed before the start of a set of movements or simultaneously with the start of the set of movements, and is maintained until at least the end of the set of movements. In this case, the processing module 4 can verify that Tp1 is less than or equal to Tm1 and that Tm2 is less than or equal to Tp2, thus validating the exercise: throughout the entire duration of the body movement exerting pressure on the pelvic floor, a contraction of the pelvic floor muscles is maintained to counteract this pressure and protect the pelvic floor muscles. In other words, there is no time interval between Tm1 and Tm2 that is not also between Tp1 and Tp2.

Claims

DEMANDS

1. System (1) for measuring pelvic floor muscle (PFM) contractions performed on a patient, the system comprising: A pelvic floor muscle probe (100) configured to be positioned inside an internal canal of the patient and in contact with the internal surface of said canal, said probe (100) comprising a body (101), an external surface (104), at least one pressure sensor (113) adapted to measure the pressure applied by the internal surface of the canal on the external surface (104) of the probe (100) and at least one motion sensor (114) adapted to detect and / or measure movement of the probe in a reference frame external to the probe (100) and the patient, A pressure measurement module (2) configured to calculate at least one differential pressure, denoted AP, in the patient's internal canal from a pressure measurement, the differential pressure AP having as a reference pressure values ​​measured in a relaxed state of the patient in which the pelvic floor muscles are relaxed, and the measurement module (2) being configured to associate at least one measured differential pressure AP with at least one pressure measurement time Tp; A motion measurement module (3) configured to detect at least one movement of the patient's body from a measurement of the movement of the probe (100) in a reference frame external to the probe (110) and the patient and configured to associate the detected movement with at least one measurement time Tm; A data processing module (4) in communication with the pressure measurement module (2) and the motion measurement module (3), the data processing module (4) being configured to calculate a difference denoted AT between the pressure measurement time Tp and the motion measurement time Tm, the data processing module (4) being further configured to check whether the difference AT complies with at least one specified condition; wherein the data processing module (4) is in communication with a notification device (5) to notify the patient that, when the difference AT between the pressure measurement time Tp and the position measurement time Tm violates the specified condition, the synergy between the contractions of the abdominal muscles and the pelvic floor muscles is suboptimal.

2. System (1) according to the preceding claim, wherein the motion sensor (114) comprises at least one accelerometer that measures an acceleration of the probe with respect to the gravitational acceleration, and wherein the motion measurement module (3) is configured to detect a body motion when the measured acceleration is greater than or equal to a determined value.

3. System (1) according to claim 1 or claim 2, wherein the probe (100) comprises at least two pressure sensors (113) operating independently of each other, and having distinct and non-overlapping detection zones, and wherein the processing module (4) measures a differential pressure in each detection zone.

4. System (1) according to any one of the preceding claims, wherein the processing module (4) is configured to calculate a first difference AT1 between a first time Tp1 of pressure measurement and a first time Tm1 of motion measurement, And in which a first condition to be respected is that the first difference AT1 is included in a determined time interval.

5. System (1) according to the preceding claim, wherein the processing module (4) is configured to calculate a second difference AT2 between a second pressure measurement time Tp2, following the first pressure measurement time Tp1, and a second motion measurement time Tm2, ​​following the first motion measurement time Tm1 And in which a second condition to be met is that the second difference AT2 is included in a determined time interval.

6. System according to the preceding claim, wherein the pressure module (2) is configured to detect the first pressure measurement time Tp1 as the initiation of a contraction and the second pressure measurement time Tp2 as the end of said contraction, and wherein the motion module (3) is configured to detect the first motion measurement time Tm1 as the beginning of a set of movements and the second motion measurement time Tm2 as the end of said set of movements.

7. A system according to any one of the preceding claims, wherein the probe (100) comprises a first section (105) intended to be placed in a proximal area of ​​the patient's internal canal and a second section (106) intended to be placed in a distal area of ​​the internal canal when the probe (100) is inserted therein, the motion sensor (114) being housed in the second section (106) of the probe (100), so that a measurement axis corresponds to the axis of a distal area of ​​the internal canal.

8. System according to claim 7, wherein the first section (105) comprises at least a first pressure sensor (113) adapted to measure the pressure applied by the patient channel on the external surface (104) of the body (101) of the probe (100) in a proximal area of ​​the channel and the second section (106) comprises at least a second pressure sensor (113) adapted to measure the pressure applied by the patient channel on the external surface (104) of the body (101) of the probe (100) in a distal area of ​​the channel.

9. System according to claim 7 or claim 8, wherein the probe is elastically flexible so that it can assume a first position called initial in which the first section (105) is inclined relative to the second section (106) by an angle (a) of inclination of a determined value called rest and a second position called curved in which the angle (a) of inclination deviates from the rest value by flexibility.

10. System according to the preceding claim, wherein the value of the angle (a) of inclination at rest is substantially equal to 162°, and wherein the value of the angle (a) of inclination when the probe (100) is in the curved position deviates from the value at rest by a maximum of plus or minus 30°.

11. System (1) according to any one of the preceding claims, wherein the notification device (5) includes an interface for visually displaying data concerning contractions performed by the patient.

12. A method for measuring pelvic floor muscle (PFM) contractions using a system according to any one of the preceding claims, the method comprising the following steps: measuring at least one differential pressure in the patient's canal, denoted AP, the differential pressure having reference pressure values measured in a relaxed state of the patient in which the pelvic floor muscles are relaxed and associate a measured differential pressure AP with a pressure measurement time Tp; detect a patient movement from at least one measurement of the probe movement and associate the detected movement with a measurement time Tm; calculate an AT difference between the pressure measurement time Tp and the position measurement time Tm and compare the AT difference with a determined condition; - notify the patient that, when the difference between the pressure measurement time Tp and the position measurement time Tm does not meet the determined condition, the synergy between body movement and pelvic floor muscle contraction is suboptimal.

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