• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The present invention relates to an orthosis, in particular an elastic venous compression orthosis, equipped with a device for measuring the duration during which said orthosis is worn.
    公开号:FR3051354A1
    申请号:FR1654389
    申请日:2016-05-18
    公开日:2017-11-24
    发明作者:Sophie Bassez；Amina Ouchene；Jean Christophe Lourme；Gregory Vaucoux
    申请人:Laboratoires Innothera SAS；
    IPC主号:
    专利说明:

    ELASTIC VENOUS COMPRESSION ORTHESIS Technical Area
    The present invention relates to an elastic venous compression orthosis, or CVE, indicated in case of venous insufficiency of a lower limb of a patient.
    State of the art
    Elastic venous compression orthoses, formerly known as "compression stockings" or "compression stockings", are textile medical devices that produce a therapeutic effect by compressing the lower limbs as opposed to the lower stockings. maintenance "(or" low support "or" low anti-fatigue ") and" low mode ", which are not medical devices for therapeutic purposes.
    Elastic venous compression orthoses are designed to produce a therapeutic effect by compressing the lower limb over a greater or lesser extent, usually with a decreasing compression profile upwardly from the ankle. The effectiveness of a treatment using an orthosis is directly related to the respect of the medical prescription by the patient. In the absence of good adherence, the disease can worsen, which entails an additional risk for the patient, but also costs for the Social Security or funding bodies of care.
    Poor compliance also makes clinical studies more difficult, especially if the patient does not report periods of non-compliance.
    Finally, improving orthotics requires a precise identification of the conditions under which the orthoses are worn.
    To verify compliance, questionnaires are traditionally used. The answers are however imprecise, even erroneous.
    There is therefore a need for a solution to improve compliance, but also knowledge of the conditions under which an orthosis is worn.
    An object of the invention is to respond, at least partially, to this need. SUMMARY OF THE INVENTION The invention proposes an orthosis intended to be brought into contact with the skin of a patient, in particular an elastic venous compression orthosis, remarkable in that it is equipped with a device for measuring the duration during which the orthosis is worn. The invention also relates to such a measuring device, which can advantageously be fixed on an orthosis. In particular, the invention relates to a device for measuring the duration during which an elastic venous compression orthosis is worn, said device comprising a capacitive sensor set so as to transmit a detection signal only when the value of a capacitance of said capacitive sensor is in a service range, the service range preferably comprising potential values of said capacitance when the orthosis is in use. Such a measuring device may also include one or more of the optional features described below for the device equipping an orthosis according to the invention. The exploitation of the data measured by the device advantageously makes it possible to benefit from precise information on the observance of the treatment. This information is useful for the patient, who can better use the orthosis, but also for the manufacturer, who can improve the orthosis, and for the prescriber, who can verify that the treatment is correctly followed.
    An orthosis according to the invention may also comprise one or more of the following optional features: the device comprises a capacitive sensor set to transmit a detection signal when the value of a capacitance of said capacitive sensor is in a service range, preferably only when the capacitance value of said capacitive sensor is in a service range; the device comprises means for controlling the conditions of said measurement, said control means preferably comprising a temperature sensor and / or a pressure sensor and / or a force sensor; the measuring device is devoid of sharp angles; the measuring device comprises a communication module, preferably by radiofrequency; the measuring device comprises an encapsulating material which hermetically isolates the electronic components of the measuring device from the outside; - The measuring device has at least one large curved surface, preferably concave; - the orthotic is an elastic venous compression orthosis. The invention also relates to a kit comprising: an orthosis according to the invention and an external module, in particular a computer and / or a mobile phone and / or a tablet, the external module comprising a computer program comprising code instructions program for: O establishing communication, preferably remotely, with the communication module of the measuring device; and / or O activate and / or deactivate the measuring device; and / or controlling an exchange of information, and in particular an unloading of information stored in a memory of the measuring device. The invention also relates to a method for improving the compliance of a treatment based on the use of an elastic venous compression orthosis and / or to improve the performance of an elastic venous compression orthosis, said method comprising the steps successive successive: a) providing an orthosis according to the invention to a patient; b) activation of the measuring device; c) preferably after a treatment period exceeding one week, preferably longer than one month, or even more than three months, unloading the data stored in the measuring device, preferably in a computer or in a mobile phone or in a Tablet ; d) analyzing said data, so as to establish an evaluation of the compliance, and preferably a correlation between the compliance, the characteristics of the orthosis and the therapeutic effect of this orthosis.
    BRIEF DESCRIPTION OF THE FIGURES Other features and advantages of the invention will become apparent on reading the detailed description which follows, and on examining the appended drawing in which: FIG. 1 schematically represents an orthosis according to the invention; ; - Figure 2 shows schematically a measuring device according to the invention, in top view (Figure 2a) and front view (Figure 2b). Definitions - "Altitude" is a level in the vertical direction when the orthosis is worn by a patient standing upright. The adjectives "higher" and "lower" are related to this same reference system. - The "service position" of an orthosis corresponds to a position of use, that is to say in which it is worn, in particular strung on a lower limb of a patient. - Unless otherwise indicated, "comprising", "comprising", "having", "including" or variations thereof corresponding to a non-exclusive inclusion.
    detailed description
    In FIG. 1, reference numeral 10 generally designates an orthosis according to the invention. The orthotic 10, generally tubular in shape, comprises a foot portion 12 wrapping the foot and a leg portion 13 having an ankle portion 14 surrounding the ankle and a calf portion 16 surrounding the calf. The orthosis 10 extends to a level below the knee, in the case where the orthosis is a sock "mid-low" (or "low-hock"). In the latter case, the orthosis is terminated by a terminal knitted part called "edge-side" 18.
    The configuration in the form of a sock is not limiting, and the orthotic 10 can also be made in the form of a "lower thigh", extended by a portion of the thigh 20 compressive. The orthotic 10 can also be made in the form of a tights, and / or free of foot portion 12 (low or sticky type "open foot").
    The various adjoining parts of the orthosis 10 are preferably knitted continuously on a circular loom, according to conventional methods. Achieving the orthotic 10 does not require any assembly step for assembling the different parts, with the exception of sewing operations of the tip at the foot portion 12, if the latter is present.
    Measuring device
    According to the invention, the orthosis comprises a device 30 for measuring the duration during which the orthosis is worn.
    Preferably, the device 30 comprises a sensor, a control module 34, a communication module 36 and an energy source, for example a battery 38, fixed on a substrate 40, the assembly being preferably encapsulated.
    Preferably, the sensor is a capacitive sensor 32 or a combination of capacitive sensors.
    In principle, a capacitive sensor measures the effect of a local electric field and detects or measures any modification of this local electric field, and in particular, a modification resulting from the approximation of the capacitive sensor of the skin. In particular, a capacitive sensor can transform the electrical disturbance of the electric field into an electrical voltage, an image of the corresponding perturbation.
    Capacitive sensors are sensors widely used in the industry.
    A capacitive sensor 32 is advantageously easy to integrate into an orthosis. In particular, unlike an optical sensor, it works even if it is hidden. In addition, it works even without being in direct contact with the patient's skin. Finally, a capacitive sensor is particularly reliable.
    The capacitive sensor transmits to the control module 34 variable information depending on the capacitive environment of the device. In particular, in a preferred embodiment, it sends a binary signal depending on whether or not the capacitance of the sensor capacitor belongs to a specific "service" range. The service range is determined according to the influence, on said capacity, of the lower limb on which the capacitive sensor is disposed in use, but also according to the other components of the device, and in particular the encapsulation material.
    In a preferred embodiment, the device comprises several sensors, preferably several sensors of different natures. In particular, the device may comprise a temperature sensor 41. The analysis of the data provided by the different sensors advantageously makes it possible to determine more precisely the conditions under which the measurements were made. For example, when the orthotic is washed, it may have moisture that would cause the capacitive sensor 32 to conclude that the orthosis is worn. If, simultaneously, the temperature sensor 41 indicates a temperature that can not match the temperature of the body of the patient, it will be easy to correct this error.
    A pressure sensor and / or a force sensor, not shown, can also be used for this purpose.
    In addition, a pressure sensor makes it possible to check the state of the orthosis, and in particular, in the compressive regions of the orthotic, to verify that the pressure exerted in service is satisfactory.
    The control module 34 conventionally comprises a microprocessor 44 capable of managing the communication to the outside, via the communication module 36, but also of controlling the capacitive sensor 32 in order to receive and store in a memory 46 the data measured by said capacitive sensor.
    In one embodiment, the control module further comprises a clock 48 for timestamping the data measured by the capacitive sensor. Advantageously, it thus becomes possible not only to measure the span time, but also to determine when the orthosis has been worn.
    The measured duration may correspond to a count of pulses generated periodically. It can be provided in the form of a duration of use or a rate of use (ratio between the duration of use and the duration of availability of the orthosis).
    The communication module 36 is known per se and makes it possible to communicate activation data and / or connection data, and / or data measured and recorded by the control module, to an external module 49, for example a computer 50 and / or a telephone 51, including a doctor.
    The communication module 36 is preferably configured for radiofrequency communication complying with the communication standards, for example of the RFID type or, preferably, NFC (in English "near field communication"), in particular by WIFI or BLUETOOTH.
    The energy source is preferably rechargeable. Preferably, the energy source is configured to recharge by means of heat energy, preferably heat released by the patient, and / or by means of mechanical energy, preferably energy resulting from body movements. of the patient.
    In one embodiment, the energy is transmitted via wireless, for example inductive, power transmission technology.
    The energy source is preferably flat. It preferably has a thickness of less than 5 mm, preferably less than 4 mm, more preferably less than 3 mm, or even less than 2 mm.
    In one embodiment, the power source is a battery that is not rechargeable.
    The substrate 40 may be of the type used for the manufacture of printed circuits, for example a polyamide film, for example Kapton®. Electrically conductive tracks are conventionally printed on the substrate, in particular between the capacitive sensor, the control module and the communication module.
    The substrate preferably has a length of less than 10 cm, preferably less than 8 cm, preferably less than 5 cm, preferably less than 4 cm, and / or a width of preferably less than 5 cm, preferably less than 4 cm. cm, preferably less than 3 cm.
    More preferably, the substrate is flat and, preferably, its outline does not present acute angles. In particular, the contour of the substrate may be round, oval or rectangular, the four corners of the rectangular contour being rounded, as shown. Preferably, the radius of curvature R is greater than 0.5 mm, greater than 1 mm, greater than 2 mm at any point in the contour of the substrate.
    More preferably, the substrate has a thickness of less than 1 mm, preferably less than 0.5 mm. It can be rigid or flexible. Preferably, it is flexible, that is to say that it can be deformed by hand, without any particular effort. Preferably, the flexibility is sufficient so that, in the operating position, the substrate takes the shape of the body part of the patient with which it is in contact. The comfort is improved.
    More preferably, an antenna 52 is printed on the substrate in order to allow a contactless communication, preferably a radio frequency communication complying with the communication standards, for example of the RFID type or, preferably, NEC, in particular by WIFI or BLUETOOTH , especially with the computer 50 and / or the telephone 51.
    Preferably, the substrate and the components attached to the substrate are encapsulated, preferably in a sealed manner, more preferably by means of a biocompatible material. The biocompatible material may in particular be chosen from the group formed by polymers and silicones.
    The biocompatibility is preferably in accordance with the NF EN ISO 10993-1 standard. Encapsulation advantageously makes it possible to increase the service life of the device, subjected, in use, to severe constraints, in particular when the orthosis is washed.
    The encapsulating material defines preferably present, from the substrate, a layer having an average thickness of less than 2 mm, preferably less than 1 mm, or even less than 0.5 mm. Preferably, the encapsulation layer defines an outer surface that is smooth to the touch.
    Preferably, the encapsulating material is flexible, preferably deformable by hand. The comfort of use is improved. Advantageously, the flexibility also allows a good adaptation to the shape of the region of the body of the patient in contact with the device (measuring zone).
    In a preferred embodiment, the encapsulation material defines two large outer faces 56 and 58, respectively extending opposite the major faces of the substrate. More preferably, at least one of the large outer faces, preferably each of the large outer faces 56 and 58 of the device is curved, preferably so as to have a shape substantially complementary to that of the part of the lower member on which it is arranged in use.
    Preferably, the large outer face 56 oriented towards the inside of the orthosis, that is to say towards the X axis, is concave.
    Preferably, the large outer face 58 facing outwardly of the orthosis, is convex.
    Preferably, the device has a maximum thickness E less than 7 mm, preferably less than 5 mm, preferably less than 3 mm.
    The device can be attached to the orthosis by any means. In particular, it can be glued, stapled or sewn. Preferably, the device is fixed so as not to protrude from the outer surface of the orthosis in use. The risk that the device is torn off is thus reduced. The discretion of the device is also improved.
    The device is preferably fixed on the edge-side of the orthosis, and in particular, when the edge-edge comprises two fabric layers folded over each other, is preferably fixed between the two said layers.
    Operation In step a), the orthosis is delivered to the patient to be treated.
    The measuring device 30, integrated in the orthosis 10 and powered by the battery 38, is initially deactivated. In step b), the activation, ie the start-up, preferably results from the reception of "activation data" sent, preferably without contact, preferably by means of a communication. NFC type, by the external module 49, for example a computer or a mobile phone, provided with a suitable application. The activation can be performed by the pharmacist or be automatic, for example when the orthotic is removed from its packaging.
    In an embodiment which is not preferred, the device may also be activated by the patient.
    The service range for capacitance sensor capacitance values is preferably, before activation, the values that said capacitance can assume when the orthotic is in the service position.
    When the orthotic is threaded by the patient to be positioned in the operating position, the environment of the device, and in particular the proximity of the skin of the patient, changes the capacitance value of the capacitor of the capacitive sensor 32. value of the capacitance of this sensor therefore falls within the service range. Preferably, the capacitive sensor 32 then sends, periodically, a corresponding elementary information. The elementary information can be time stamped by means of the clock 48. The control module 34 calculates the total number of these elementary information.
    When the patient removes the orthotic, the value of said capacity comes out of said range of service and the transmitted elementary information is no longer taken into account. When the patient puts on the orthotic again, the elementary information transmitted by the capacitive sensor is again taken into account and the control module resumes the counting. The total number of basic information counted is thus in proportion to the total span time of the orthotic.
    In particular, when the orthotic is washed, the encapsulation material 54 protects the electronic components. The environment, during washing, and even more during drying, can lead to errors, the capacitive sensor 32 considering that the orthosis is in its service position. Tests have shown that such errors do not substantially modify the results obtained. In particular, the time during which the error occurs is very small in comparison with the span time.
    However, to improve the accuracy, the second sensor 41 can provide another measurement, and in particular a temperature measurement, or another capacitive sensor for detecting the error, and thus to filter the erroneous data. In step c), the measured data is discharged, for example to the external module 49.
    The data recorded by the control module 34 may be transmitted in real time and / or at regular intervals to the external module 49. Preferably, however, they are stored in the memory 46 until an NFC type communication is established. . The connection can in particular result from the reception of "connection data" sent by the external module. Preferably, the external module is a telephone or a dedicated terminal. The unloading of the data may in particular be carried out when the patient returns to see his doctor with the orthosis, preferably by the patient or the doctor. In step d), the analysis of the data received by the control module (data measured by the various sensors, time stamp data) can be performed by the microprocessor 44 of the control module and / or by the external module, after this data has been transmitted by the communication module 36.
    Depending on the richness of the data, it is possible to determine the "span time", but also the time ranges during which the orthosis was worn and / or the conditions in which the orthosis was worn, in particular. The analysis can also lead to an evaluation of the total span time and / or the number of washes and / or the washing conditions, and / or, if the measuring device comprises a pressure sensor, the pressure exerted locally by the orthosis. In one embodiment, the analysis of this information makes it possible to indicate whether the orthosis should be replaced, in particular if it is no longer effective.
    In one embodiment, all data relating to a patient is consolidated for a specified period, in particular to take into account the use of multiple orthoses during said period.
    The physician can analyze the data to improve the treatment, and / or transmit them, preferably anonymously, to the manufacturer of the orthotic so that he can improve the properties. In one embodiment, the physician also transmits information relating to the effectiveness of the treatment and / or relating to the feeling of the patient, particularly with regard to comfort. The manufacturer can thus establish links between the characteristics of the orthotic and this information, which makes it possible to accelerate the improvement of the orthosis. The analysis can lead to a diagnostic report, preferably providing recommendations to the patient, for example to indicate that the span time is insufficient or that the orthotic is not worn properly or that it must be replaced.
    If the recorded data are time-stamped, the analysis also makes it possible to detect the periods during which the orthosis is worn, but also to detect the time elapsed between the activation and the first use of the orthosis.
    Of course, the invention is not limited to the embodiments described and shown, provided for illustrative purposes only.
    In particular, several external modules can be implemented to activate the measuring device, connect the measuring device to discharge the stored data or analyze the received data.
    In addition, the invention is intended for an elastic venous compression orthosis, but is not limited to such an application. The invention does not however relate to implanted medical devices. An orthosis according to the invention is worn on the skin.
    权利要求:
    Claims (12)
    [1" id="c-fr-0001]
    An orthosis intended to be brought into contact with the skin of a patient, said orthosis being equipped with a device for measuring the duration during which said orthosis is worn.
    [2" id="c-fr-0002]
    2. An orthosis according to the immediately preceding claim, wherein the device comprises a capacitive sensor (32) set to transmit a detection signal when the value of a capacitance of said capacitive sensor is in a range of service.
    [3" id="c-fr-0003]
    3. An orthosis according to any one of the preceding claims, wherein the device comprises means for controlling the conditions of said duration measurement.
    [4" id="c-fr-0004]
    4. An orthosis according to the immediately preceding claim, wherein said control means comprise a temperature sensor (41) and / or a pressure sensor and / or a force sensor.
    [5" id="c-fr-0005]
    An orthosis according to any one of the preceding claims, wherein the measuring device is devoid of sharp angles.
    [6" id="c-fr-0006]
    An orthosis according to any one of the preceding claims, wherein the measuring device comprises a radio frequency communication module (36).
    [7" id="c-fr-0007]
    An orthosis according to any one of the preceding claims, wherein the measuring device comprises an encapsulating material (54) hermetically isolating the electronic components of the measuring device from the outside.
    [8" id="c-fr-0008]
    8. An orthosis according to any preceding claim, wherein the measuring device has at least one large curved surface (56; 58), preferably concave.
    [9" id="c-fr-0009]
    9. An orthosis according to any one of the preceding claims, the orthosis being an elastic venous compression orthosis.
    [10" id="c-fr-0010]
    10. Kit comprising: - an orthosis (10) according to any one of the preceding claims and - an external module (49), in particular a computer and / or a mobile phone and / or a tablet, the external module comprising a program computer system comprising program code instructions for: establishing a communication, preferably remotely, with the communication module of the measuring device; and / or O activate and / or deactivate the measuring device; and / or controlling an exchange of information, and in particular an unloading of information stored in a memory of the measuring device.
    [11" id="c-fr-0011]
    A method for improving adherence to treatment based on the use of an orthotic and / or to improve the performance of an orthotic, said method comprising the following successive steps: a) supplying a patient with an orthosis according to any one of claims 1 to 9; b) activation of the measuring device; c) preferably after a treatment period exceeding one week, preferably longer than one month, or even more than three months, unloading the data stored in the measuring device, preferably in a computer or in a mobile phone or in a Tablet ; d) analyzing said data, so as to establish an evaluation of the compliance, and preferably a correlation between the compliance, the characteristics of the orthosis and the therapeutic effect of this orthosis.
    [12" id="c-fr-0012]
    12. A device for measuring the duration during which an elastic venous compression orthosis is worn, said device comprising a capacitive sensor (32) set so as to transmit a detection signal only when the value of a capacitance of said capacitive sensor is in a service range, the service range preferably comprising potential values of said capacity when the orthosis is in use.
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    法律状态:
    2017-03-30| PLFP| Fee payment|Year of fee payment: 2 |
    2017-11-24| PLSC| Publication of the preliminary search report|Effective date: 20171124 |
    2018-03-30| PLFP| Fee payment|Year of fee payment: 3 |
    2019-04-30| PLFP| Fee payment|Year of fee payment: 4 |
    2020-04-27| PLFP| Fee payment|Year of fee payment: 5 |
    2021-03-31| PLFP| Fee payment|Year of fee payment: 6 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1654389A|FR3051354B1|2016-05-18|2016-05-18|ELASTIC VENOUS COMPRESSION ORTHESIS|
    FR1654389|2016-05-18|FR1654389A| FR3051354B1|2016-05-18|2016-05-18|ELASTIC VENOUS COMPRESSION ORTHESIS|
    RU2017116983A| RU2737879C2|2016-05-18|2017-05-16|Elastic venous compression orthesis|
    CA2967626A| CA2967626A1|2016-05-18|2017-05-17|Elastic venal compression orthotic|
    DE102017110817.3A| DE102017110817A1|2016-05-18|2017-05-18|Elastic venous compression orthosis|
    US15/598,953| US20170333256A1|2016-05-18|2017-05-18|Elastic venous compression orthosis|
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