FR3096574A1 - METHOD FOR DETERMINING THE WEAR OF AN ORTHESIS - Google Patents

Abstract

Method for determining the wearing of an orthosis The invention relates to a method for determining the wearing of an orthosis (10) by a user comprising the following steps: - providing an orthosis (10) comprising at least a first sensor ( 12) measuring at least one parameter relating to a possible interaction of the orthosis (10) with a user and at least one second sensor (14) measuring at least one parameter relating to the user's actimetry, - acquisition of first data by at least one first sensor (12), - acquisition of second data by at least one second sensor (14), and - simultaneous processing of the first data provided by at least one first sensor (12) and second data supplied by the at least one second sensor (14) to determine whether the orthosis (10) is worn. Figure 1

Description

Procedure for determining the wearing of an orthosis

The present invention relates to a method for determining the wearing of an orthosis by a user.

Such a process notably allows a patient to have feedback on his use of the orthosis or to verify that he is indeed following a given treatment and/or a medical practitioner to ensure the follow-up of said patient.

Document US 9,839,553 describes a compression belt comprising a tightening system using a cable. It is detected that the belt is not worn when there is no tension in said cable.

However, in some situations, the cable is likely to be stretched even if the belt is not worn. For example, if the belt is stowed with the cable held taut by an external object, it is likely to be misinterpreted that the belt is worn by the user.

Furthermore, not all belts include a tightening system using a cable, so that such a system is not suitable for other types of belt or for other orthoses without a tightening cable.

An object of the invention is therefore to propose a method for determining the wearing of an orthosis that is reliable and adaptable to different types of orthosis.

To this end, the subject of the invention is a method for determining the wearing of an orthosis by a user comprising the following steps:

- supply of an orthosis comprising at least a first sensor measuring at least one parameter relating to a possible interaction of the orthosis with the user and at least a second sensor measuring at least one parameter relating to the actimetry of the user ,

- acquisition of first data by the at least one first sensor,

- acquisition of second data by the at least one second sensor, and

- simultaneous processing of the first data provided by the at least one first sensor and the second data provided by the at least one second sensor to determine whether the orthosis is worn.

The use of these two types of sensors allows a better reliability of detection of the wearing of the orthosis by crossing the data obtained. Furthermore, such a system can be adapted for any type of orthosis by providing said sensors.

The determination method may also have one or more of the characteristics below, considered individually or in all technically possible combinations:

- the at least one parameter relating to a possible interaction of the orthosis with the user is the pressure applied by the orthosis on a user, the elongation of the orthosis, the closure of the orthosis, the magnetic field surrounding the first sensor and/or the temperature surrounding the first sensor;

- during the data processing step, if, during a first period greater than a first minimum period, the parameter relating to a possible interaction of the orthosis with the user measured by the first sensor is greater than a first value predetermined value and if, during a second period greater than a second minimum period, the parameter relating to the actimetry is greater than a second predetermined value, it is determined that the orthosis is worn;

- during the data processing step, if, during a first period greater than a first minimum period, the parameter relating to a possible interaction of the orthosis with the user measured by the first sensor is less than a first value predetermined value or if, during a second period greater than a second minimum period, the parameter relating to actimetry is less than a second predetermined value, it is determined that the orthosis is not worn;

- a low-pass frequency filter is applied to the first data before the step of simultaneous processing of the first data and/or a band-pass frequency filter is applied to the second data before the step of simultaneous processing of the first data;

- during the data processing step, the second data is compared with one or more patterns corresponding to different types of movements so as to recognize the nature of any movement made by the user;

- if, during the step of simultaneous data processing, it is determined that the orthosis is worn, then the method comprises a step of determining a level of tightness of the orthosis;

- the orthosis comprises a module comprising a processor, the at least one first sensor and the at least one second sensor being connected to the processor, the method comprising the steps of:

- transmission of the parameter relating to a possible interaction of the orthosis with the user from the at least first sensor to the processor, and

- transmission of at least one parameter relating to the user's actimetry from at least one second sensor to the processor,

the simultaneous data processing step being carried out by the processor;

- the module comprises a radio wave transmitter connected to the processor, the method comprising a step of transmitting at least one result of the step of simultaneous processing of the data from the processor of the module to an external computer by the transmitter;

- the method includes a step of transmitting the tightening level of the processor of the module to the external computer by the transmitter; and or

- the orthosis has an identifier, the identifier being associated with mechanical characteristics of the orthosis parameters of the simultaneous data processing step depending on said mechanical characteristics;

Other characteristics and advantages of the invention will appear on reading the following description of embodiments of the invention, given by way of example only and with reference to the drawings in which:

FIG. 1 is a schematic view of an example of an assembly comprising an orthosis seen from the outside of said orthosis and an external computer,

Figure 2 is a schematic view of the orthosis of Figure 1 seen from the inside, and

Figure 3 is a schematic block view of an embodiment of the method of the invention.

The invention relates to a method for determining the wearing of an orthosis by a user.

An exemplary embodiment of the method includes the following steps:

- supply 110 of an orthosis 10 comprising at least a first sensor 12 and at least a second sensor 14,

- acquisition 120 of first data by the at least one first sensor 12,

- acquisition 130 of second data by the at least one second sensor 14, and

- 130 simultaneous processing of the first data provided by the first sensor 12 and the second data provided by the second sensor 14 to determine whether the orthosis 10 is worn.

An example of orthosis 10 provided, in the form of a lumbar belt, is represented in FIGS. 1 and 2. It is understood that the invention applies to any other type of orthosis, such as a knee brace, an elbow brace, ankle brace or other. In the remainder of the description and for reasons of simplicity, the orthosis 10 will be described as being a lumbar belt.

The orthosis 10 is, for example, associated with an identifier, for example unique. The identifier is associated with the mechanical characteristics of the orthosis, such as its nature (belt, knee pad, etc.) and/or the precise model of the orthosis. The identifier takes for example the form of a series of alphanumeric or other signs.

The orthosis 10 comprises an orthosis body 16 intended to surround at least a part of the body of a user when the orthosis 10 is worn by this user.

The orthosis body 16 comprises a first end 15A and a second end 15B, the first end 15A and the second end 15B being attached to each other in a reversible manner, for example using Velcro strips provided with a system of textile hooks and loops, when the orthosis body 16 is worn by a user, so as to surround said part of the body.

The orthosis body 16 is, for example, woven or knitted.

The orthosis body 16 here comprises at least one elastic part 17.

The elastic part 17 is located in a distal part, here ventral, of the orthosis body 16, here close to the second end 15B.

The first sensor 12 is irremovably fixed to the orthosis body 16 at a given location.

It is, for example, integrated into said orthosis body 16.

“Integrated” means that the first sensor 12 is incorporated into the orthosis body 16. It is, for example, inserted into the fabric or knit forming the orthosis body 16. Alternatively, the first sensor 12 does not is not inserted into the fabric or the knit, but all the connections of said first sensor 12 are.

Alternatively, the first sensor 12 is removably attached to the orthosis body 16 at a given location. The given location is fixed on the orthosis body 16, so as to allow repeatability of the measurements.

The first sensor 12 is here fixed to the elastic part 17.

The first sensor 12 measures at least one parameter relating to a possible interaction of the orthosis with the user

The first sensor 12 measures, for example, the pressure applied by the orthosis to a user or the elongation of the orthosis.

The first sensor 12 is, for example, a capacitive pressure sensor, that is to say it has a capacity which increases when pressure is applied to the sensor, said capacity being measured to calculate the corresponding pressure.

Alternatively, the first sensor 12 is a resistive pressure sensor.

Additionally or alternatively, the first sensor is capable of measuring the elongation of a wire or of a portion of the orthosis 10. The term elongation of the orthosis 10 is then understood to mean the elongation of said wire or of said portion of orthosis 10.

The first sensor 12 is, for example, able to measure the elongation in the elastic part 17.

The first sensor 12 is, for example, an inductive elongation sensor or a resistive elongation sensor based on an elastic optical fiber integrating conductors as described in WO 2017137945 A1 or WO2014047660 A1.

The orthosis 10 advantageously comprises an additional temperature sensor capable of measuring the temperature of the first sensor 12 or around it. This makes it possible in particular to adjust the measurement of the first sensor 12 as a function of the temperature, in cases where a variation in temperature would be likely to cause a drift in the measurements made by the first sensor 12.

Alternatively, the measurement performed by the first sensor 12 is not sensitive to temperature, at least over a range of use. The orthosis does not include an additional temperature sensor capable of measuring the temperature of the first sensor 12 or around it.

Alternatively, the first sensor 12 measures the detection of the closure of the orthosis, the magnetic field surrounding the sensor and/or the temperature surrounding the sensor.

The magnetic field and/or the temperature surrounding the first sensor vary when a user is wearing the orthosis compared to when the orthosis is not worn.

The second sensor 14 measures at least one parameter relating to the actimetry of the user.

The second sensor 14 is, for example, a motion sensor operating along 3 axes, that is to say able to measure the movement along three axes forming a space, or a gyroscope.

The parameter relating to the actimetry is for example a measurement on each axis of the acceleration, i.e. three measurements.

The second sensor 14 is, for example, removably fixed to the orthosis body 16. More particularly, the second sensor 14 is fixed to a fixed given location on the orthosis body 16.

More particularly, in the embodiment represented, the orthosis comprises a module 18 comprising the second sensor 14. Said module 18 is here fixed in a removable manner to the body of the orthosis 16.

The module 18 is fixed close to the first sensor 12, more particularly in the elastic part 17 of the orthosis body 16.

Module 18 also includes a processor 20.

The processor 20 is able to process data coming from the first sensor 12 and from the second sensor 14 by software.

Processor 20 has a 32-bit architecture.

The processor 20 is associated with a memory, in particular to store the data coming from the first sensor 12 and from the second sensor 14.

The processor 20 is advantageously associated with an internal clock.

The processor 20 is, for example, a microprocessor.

The first sensor 12 and the second sensor 14 are each connected to the processor 20, so as to allow the transmission of data from each of said sensors 12, 14 to said processor 20.

The second sensor 14 is here connected directly to the processor 20 within the module 18, for example, by wire.

The first sensor 12 is wired to the processor 20.

In the embodiment represented, the module 18 comprises a connection interface 22 connected by wire to the processor 20. The first sensor 12 is able to be connected in a removable manner to the connection interface 22. More particularly, at least one electrical connection wire 26 is connected at a first end to the first sensor 12 and at a second end to a connection terminal provided to be connected in a reversible manner to the connection interface.

The electrical connection wire is, for example, integrated into the orthosis body 16, more particularly in the fabric or the knit forming the orthosis body 16.

The additional temperature sensor is also connected to said processor 20, more particularly by wire to connection interface 22 of module 18.

Alternatively, the first sensor 12, the second sensor 14 and/or the additional temperature sensor are connected to the processor 20 wirelessly, for example by a wireless communication means such as by radio waves or by near field communication ( or NFC of “ Near Field Communication ”).

The module 18 further comprises a transmitter 24 connected to the processor 20, for example, by wired connection within the module 18.

The transmitter 24 uses, for example, radio waves. It follows, for example, the Wi-Fi ^TM protocol or the Bluetooth ® standard.

Alternatively, the transmitter 24 uses near field communication (or NFC for “ Near Field Communication ”).

Transmitter 24 is capable of transmitting a signal comprising data transmitted by processor 20.

In an alternative embodiment not shown, the first sensor of the orthosis provided is integrated into the module, the module being designed to be removably fixed to the body of the orthosis similar to above. The first sensor is then connected directly to the processor within the module, for example, by wire.

During the first data acquisition step 120, the at least one first sensor 12 acquires first data corresponding to at least one parameter relating to a possible interaction of the orthosis with the user, as described previously.

The measurements are taken by the first sensor 12 at regular intervals.

Alternatively, the first sensor 12 acquires measurements continuously.

The first data is then transmitted to the processor 20.

The first data is likely to undergo one or more data pre-processing by the processor 20 after the transmission.

Alternatively, the preprocessing(s) are carried out before or during the transmission by the processor 20, for example, using processing module(s) located on the connection between the first sensor 12 and the processor 20. In In this case, the first transmitted data means the first pre-processed and transmitted data.

The preprocessing(s) correspond, for example, to denoising in particular by frequency filtering.

Denoising by frequency filtering corresponds, for example, to the application of a low-pass filter, more particularly which removes or attenuates frequencies above a given frequency.

During the second data acquisition step 130, the at least one second sensor 14 acquires second data corresponding to at least one parameter relating to the actimetry of the user, as described previously.

As seen previously, the at least one parameter relating to the actimetry is for example a measurement on each of three axes of the second sensor 14 of the component of the acceleration. The second data then therefore includes the components of the acceleration in a given space.

The measurements are taken by the second sensor 14 at regular intervals, for example, with a frequency of 25 Hz.

Alternatively, the second sensor 14 acquires measurements continuously.

The second data is then transmitted to the processor 20.

The second data is likely to undergo one or more data pre-processing by the processor 20 after the transmission.

Alternatively, the pre-processing(s) are carried out before or during the transmission, for example, using processing module(s) located on the connection between the second sensor 14 and the processor 20. In this case, means by the second data transmitted, the second data preprocessed and transmitted.

The preprocessing(s) correspond, for example, to denoising in particular by frequency filtering.

Denoising by frequency filtering corresponds, for example, to the application of a band-pass filter. More particularly, the filter suppresses or attenuates, for each parameter, the frequencies higher than a given maximum frequency and the frequencies lower than a given minimum frequency.

The maximum frequencies for each of the components of the acceleration are, for example, equal to each other. They are here of the order of 10 Hz. It is thus considered that a movement presenting a frequency higher than 10 Hz is not carried out by a human. This is, for example, the vibration of a machine such as a car.

If a user wears the orthosis in a car, the band-pass filter then makes it possible to attenuate or eliminate the part of the signal of the second data corresponding to the vibration of the car, in order to make it possible to isolate the movement of said user.

The first and second transmitted data are then processed.

The simultaneous data processing step 140 is here performed by the processor 20.

The processor 20 considers, for example, initially that the orthosis is not worn.

If a first wearing condition and a second wearing condition are fulfilled concurrently, then it is determined that the orthosis 10 is worn.

The first wearing condition here is that during a first period greater than a first minimum period, the pressure or the elongation measured by the first sensor 12 is greater than a first predetermined value MinP.

The first predetermined value MinP corresponds here to a minimum pressure or to a minimum elongation.

More particularly, the first data are here acquired at regular intervals with a given step.

If, for a first measurement number greater than a first number NbP, the parameter relating to a possible interaction of the orthosis with the user measured by the first sensor 12 is greater than a first predetermined value, then it is considered that the first port condition is met.

The second wearing condition here is that during a second period greater than a second minimum period Tobs, the parameter relating to the actimetry is greater than a second predetermined value.

The second predetermined value corresponds to a minimum movement value on each of the axes.

Thus, the respective component of the movement recorded on each of the axes is greater than a respective given value MinX, MinY, MinZ.

It is thus considered that a human always presents a minimal movement, including when he does not move or does not perform large gestures.

Alternatively, the second condition is met when at least one of the respective components of the movement recorded on each of the axes is greater than the respective given value MinX, MinY, MinZ.

The first period is included in the second period or the second period is included in the first period.

Here the first period and the second period coincide.

In a particular embodiment, the fulfillment of the first condition is looked at only if a movement is detected, that is to say if at least one parameter relating to the actimetry is greater than an activation value. More particularly, the first sensor is activated so as to acquire measurements only if the parameter relating to the actimetry is greater than the activation value.

Parameters such as the first period or the first number NbP, the first value MinP, the second value MinX, MinY, MinZ and/or the second period Tobs depend, for example, on the mechanical characteristics of the orthosis associated with the identifier.

Said parameters are recorded beforehand in the memory associated with the processor.

The parameters are likely to be updated by connecting the processor to a remote database. The update will, for example, be carried out automatically when the processor is connected to a suitable external computer.

This makes it possible in particular to adjust the parameters as best as possible and to provide, for example, a learning process.

In a particular case, the processor knowing the identifier, the data processing is automatically adapted to the orthosis, for example, to its nature or to the given model.

Alternatively, the nature and/or the orthosis model are previously configured in the processor.

When the wearing of the orthosis is detected whereas previously the orthosis was indicated as not worn, the processor records an event corresponding to the start of wearing the orthosis to which a date provided by the internal clock is associated.

The event is recorded in the memory connected to the microcontroller.

When the orthosis is previously detected worn, but one of the first and second conditions for removal is fulfilled, then it is detected that the orthosis is no longer worn.

The first condition here is that during a first period greater than a first minimum period, the parameter relating to a possible interaction of the orthosis with the user measured by the first sensor 12 is less than a first predetermined value MinP.

The first period and the first associated number NbP and the first predetermined value MinP are here identical to those of the first condition.

The second condition here is that during a second period greater than a second minimum period Tobs, the parameter relating to the actimetry is less than a second predetermined value.

The second period Tobs and the second predetermined value MinX, MinY, MinZ are here identical to those of the first condition.

The processor then records an event corresponding to the end of wearing of the orthosis with which a date provided by the internal clock is associated.

The event is recorded in the memory connected to the microcontroller.

Furthermore, if, during the simultaneous data processing step, it is determined that the orthosis is worn, then the method further comprises a step of determining a level of tightness of the orthosis.

Further, during processing step 140, the second data is analyzed to recognize a particular movement.

For example, one or more patterns corresponding to different types of movements, such as walking or running, are recorded beforehand in the memory connected to the microcontroller, the microcontroller comparing the second data to the different patterns, so as to identify the possible nature of a movement performed by a user.

Following the processing step 140, the method advantageously comprises a step 150 of transmitting at least one result of the step 140 of simultaneous processing of the data from the processor of the module 18 to an external computer 30 by the transmitter 24.

The at least one result transmitted to the external computer 30 includes the events of the start and end of wearing the orthosis and the associated dates, and advantageously the respective tightness level.

The external computer 30 is capable of displaying the at least one result transmitted to allow follow-up, for example, for the user and/or for a medical practitioner following said user.

Advantageously, the external computer 30 calculates additional information from the at least one result transmitted by the transmitter 24, in particular the wearing time of the orthosis.

Advantageously, the microcontroller goes into standby automatically after a given period during which no movement is detected. In particular, this makes it possible to limit electrical consumption as long as the seat belt is not detected as being worn.

In the event of movement, the microcontroller is taken out of standby mode as soon as a start of movement is detected.

Such a system makes it possible, for example, to have an autonomy of several days of operation with a battery of approximately 100mAh/3V with a reduced volume.

In an embodiment not shown, the orthosis comprises a plurality of first sensors 12 measuring the at least one parameter relating to a possible interaction of the orthosis with the user and/or a plurality of second sensors 14 measuring at least a parameter relating to the actimetry of the user.

In the case of a plurality of first sensors 12, one considers, for example, the at least one parameter relating to a possible interaction of the orthosis with the measured user as a point of comparison in the step of simultaneous processing of the data. Indeed, if one of the first sensors measures, for example, a low pressure or elongation, it can be considered that the pressure or the elongation is only applied at a given location and not on the whole of the orthosis, unlike the case where the orthosis surrounds a part of the user's body.

In the case of a plurality of second sensors 14, the second data is crossed to better characterize and/or quantify the movement of the user.

It is understood that the invention applies to any other type of orthosis, such as a knee brace, an elbow brace, an ankle brace or the like, with similar first and second sensors.

In particular, if an orthosis does not include an elastic part, the first sensor will be a sensor of the pressure applied by the orthosis on the user.

The use of two types of sensors and the simultaneous processing of the data allow a better reliability of detection of the wearing of the orthosis by crossing the data obtained and by more reliably detecting the situation at a given moment.

This allows in particular to have better data for the medical follow-up of a patient or a better feedback to a user.

The repetition of measurements makes it possible in particular to check compliance with a treatment. In addition, the data obtained by the orthosis can be linked to other information, such as the pain or discomfort felt by the patient, to know if the orthosis is effective.

Claims (10)

Method for determining the wearing of an orthosis (10) by a user comprising the following steps:
- supply of an orthosis (10) comprising at least one first sensor (12) measuring at least one parameter relating to a possible interaction of the orthosis (10) with a user and at least one second sensor (14) measuring at least a parameter relating to the actimetry of the user,
- acquisition of first data by the at least one first sensor (12),
- acquisition of second data by the at least one second sensor (14), and
- simultaneous processing of the first data provided by the at least one first sensor (12) and the second data provided by the at least one second sensor (14) to determine whether the orthosis (10) is worn. Method according to claim 1, in which the at least one parameter relating to a possible interaction of the orthosis with the user is the pressure applied by the orthosis (10) on a user, the elongation of the orthosis ( 10), the closure of the orthosis (10), the magnetic field surrounding the first sensor (12) and/or the temperature surrounding the first sensor (12). Method according to claim 1 or 2, in which, during the data processing step, if, during a first period greater than a first minimum period, the at least one parameter relating to a possible interaction of the orthosis with the user measured by the first sensor (12) is greater than a first predetermined value and if, during a second period greater than a second minimum period, the parameter relating to actimetry is greater than a second predetermined value, it is determined that the orthosis (10) is worn. Method according to any one of Claims 1 to 3, in which, during the step of processing the data, if, during a first period greater than a first minimum period, the at least one parameter relating to a possible interaction of the orthosis with the user measured by the first sensor (12) is less than a first predetermined value or if, during a second period greater than a second minimum period, the parameter relating to the actimetry is less than a second predetermined value , it is determined that the orthosis (10) is not worn. A method according to any one of claims 1 to 4, wherein a low pass frequency filter is applied to the first data before the step of simultaneously processing the first data and/or a band pass frequency filter is applied to the second data before the step of simultaneous processing of the first data. Method according to any one of claims 1 to 5, in which during the step of processing data, the second data is compared with one or more patterns corresponding to different natures of movements so as to recognize the nature of a movement possibly made by the user. A method according to any of claims 1 to 6, wherein if, during the step of simultaneously processing the data, it is determined that the orthosis (10) is worn, then the method comprises a step of determining a level of tightening of the orthosis (10). A method according to any of claims 1 to 7, wherein the orthosis (10) comprises a module (18) comprising a processor (20), the at least one first sensor (12) and the at least one second sensor (14) being connected to the processor (20), the method comprising the steps of:
- transmission of the pressure applied by the orthosis on a user or of the elongation of the orthosis from the at least first sensor (12) to the processor (20), and
- transmission of at least one parameter relating to the user's actimetry from the at least one second sensor (14) to the processor (20),
the simultaneous data processing step being performed by the processor (20). Method according to claim 8, in which the module (18) comprises a radio wave transmitter (24) connected to the processor (20), the method comprising a step of transmitting at least one result of the step of simultaneously processing the data from the processor (20) of the module (18) to an external computer (30) by the transmitter (24). A method according to claims 7 and 9, wherein the method includes the step of transmitting the tightness level of the processor (20) of the module (18) to the external computer (30) by the transmitter (24).