METHOD FOR MONITORING THE DISPENSING OF A DROP AND ASSISTANCE DEVICE

Abstract

The invention relates to a method for monitoring the dispensing of a drop by a device for dispensing a liquid product in the form of drops, using liquid product detection means arranged in the vicinity of a drop dispensing orifice, and a system (40) for processing the information provided by the detection means, a monitoring method during which the processing system (40) receives information corresponding to the succession of the following steps: - a step of detecting the presence of liquid, during which the detection means detect the presence of liquid in the vicinity of the dispensing orifice, the detection means being configured so that the detection of the presence of liquid is significant of a drop being formed, in contact with the dispensing orifice,- a step of detecting the absence of liquid during which the detection means detect the absence of liquid in the vicinity of the dispensing orifice, and the processing system (40) processes this successive detection information of the presence and absence of liquid to provide information on the dispensing of a drop. The invention also relates to a device (10) for assisting in the use of a device for dispensing liquid product in the form of drops.,

Description

=1- Method for monitoring the distribution of a drop and assistance device

[0001] | The invention relates to a method for monitoring the distribution of a drop by a device for distributing a liquid product in the form of drops and a device for assisting in the use of such a distribution device.

[0002] When dispensing a liquid product in the form of drops, it can be useful to know whether the drop has been dispensed correctly. For example, in the administration of medical products, it is useful, both for the user and for monitoring administration, to detect the dispensing of a drop to control the amount of medication administered. For example, insufficient intake or an overdose of medication must be avoided to protect the patient's health, or it also allows the remaining quantity of product in the dispensing device to be known later.

[0003] US patent 2014 / 0257206 describes a control device for the instillation of ophthalmic fluid drops comprising a drop detector based on optical principles capable of detecting the passage of a drop. However, this method does not allow for the detection of actual drop distribution in the subject's eye.

[0004] … The invention aims in particular to provide a method for monitoring the distribution of a drop and an assistance device to better determine whether a drop has actually been distributed.

[0005] To this end, the invention relates in particular to a method for monitoring the distribution of a drop by a device for distributing a liquid product in the form of drops, using liquid product detection means disposed near a drop distribution orifice, and a system for processing the information provided by the detection means, a monitoring method during which the processing system receives information corresponding to the succession of the following steps: - a liquid presence detection step, during which the means of The detectors detect the presence of liquid in the vicinity of the dispensing orifice, detection methods being configured so that the detection of the presence of The liquid is indicative of a drop in the process of forming, in contact with the orifice distribution, - a liquid absence detection step, during which the means of detection detects the absence of liquid in the vicinity of the dispensing orifice, and the processing system handles this successive detection information of presence and absence of liquid to provide information on the dispensing of a drop.

[0006] | The monitoring method thus provides information regarding the disappearance of a droplet in the vicinity of the dispensing orifice, by observing the presence and then the absence of a droplet in the same location during two successive steps. This sequence of "presence, absence" of a droplet makes it possible to determine whether the formed droplet has actually fallen. In particular, it allows for the detection of cases of misuse of the dispensing device, which might not necessarily be detected by simply observing the appearance of a droplet without subsequently observing whether the droplet is absent, especially if it has detached from the dispensing orifice. For example, when the pressure applied to the dispensing device is too low, the detected droplet may not be dispensed and may remain in place as a residual droplet.The proposed monitoring method then makes it possible to detect this residual drop and to deduce that the drop has not detached, in order, for example, to signal this to the user and / or to avoid distorting the count of drops distributed or to be distributed.

[0007] … The information provided by the processing system at the end of the monitoring process is, for example, information allowing the correct distribution of a drop to be attributed, when the sequence "presence, absence" has been detected, and / or information allowing the incorrect distribution of a drop to be attributed, when this sequence is not detected.

[0008] It should be noted that the information processing may take into account other information made available to the processing system in order, for example, to supplement or improve the information provided. This information includes, for example, the pressure exerted on the dispensing device, the duration of the presence of the detected droplet in the vicinity of the dispensing orifice, etc.

[0009] It is understood that the detection means are configured not only so that the detection of the presence of liquid in the vicinity of the detection orifice is indicative of a drop in the process of forming, in contact with the distribution orifice, but also so that the detection of the absence of liquid in this same vicinity of the distribution orifice is indicative of a drop that has detached from the distribution orifice, and which is therefore no longer in contact with the distribution orifice. By A "drop in formation" is a drop of liquid that has not yet detached from the dispensing orifice. Thus, liquid that has been in contact with the dispensing orifice for a short or long period, and which has therefore not detached, is considered a "drop in formation".

[00010] The monitoring method may further include one or more of the following features, taken alone or in combination.

[00011] — The monitoring method includes, before the liquid presence detection step, referred to as the second detection step, a liquid absence detection step, referred to as the first detection step, during which the detection means detect the absence of liquid in the vicinity of the dispensing orifice. This first detection step is particularly advantageous in that it makes it possible to identify not only a drop that has detached from the dispensing orifice, but also the appearance of a drop in the vicinity of the dispensing orifice, thanks to the observation of an absence followed by a presence of a drop. Thus, the sequence of "absence, presence, absence" of a drop makes it possible to identify whether the drop is newly formed and has indeed fallen.In particular, this ensures that the dispensing orifice does not contain a residual droplet, which could pose a contamination risk if it has been present for some time, or which could indicate an unsuitable droplet size. A particularly advantageous feature is that, if this initial detection step fails, the assistance device can signal a malfunction, prompting the user to clean the dispensing orifice and remove the residual droplet.

[00012] — The monitoring method includes, prior to the liquid presence detection step, referred to as the second detection step, a step for detecting the activation of a drop dispenser, for example, following pressure applied to a support area or a certain tilt of the dispensing device. This prior activation detection step is advantageous because it ensures that the liquid detected during the second detection step originates from a deliberate activation of a drop dispenser. For example, if a drop is dispensed into one eye and then another into the second eye, it is possible that the absence of liquid may not be detected during the first detection step due to residual liquid remaining in the dispensing orifice between the dispensing into the first eye and that into the second eye.However, this residual liquid is not problematic because it is not exposed to air for long periods and therefore is not likely to be contaminated. Another advantage of this earlier activation detection step is that it's possible to activate the detection means only when the user begins using the assistive device and thus triggers the dispensing of a drop. This saves energy, as there may not be enough time to pass through a liquid absence detection phase before detecting the presence of liquid.

[00013] - The detection means emit a detection signal in the vicinity of the dispensing orifice, receive said emitted detection signal, and detect the presence of liquid by receiving a detection signal that is disturbed compared to a detection signal received in the absence of liquid. The detection signal is preferably an optical signal, for example, an infrared beam. "Optical" means any electromagnetic wave, whether in the visible or non-visible spectrum. The optical detection means used for this purpose are generally capable of emitting, receiving, and / or reflecting such a wave. The optical detection means comprise a transmitter and a receiver, either separate and preferably diametrically opposed with respect to the dispensing orifice, or combined or juxtaposed on the same component and receiving a detection signal by possible reflection off an opposite wall.

[00014] — The monitoring method includes a step in which the time elapsed between the start of the liquid presence detection step and the start of the liquid absence detection step is measured. The processing system assigns an incorrect drop distribution when the elapsed time is less than a first predetermined time threshold, and preferably, information corresponding to this incorrect or correct distribution is made available to a user. The viscosity of the liquid product and the drop formation time influence the drop volume. In particular, the drop volume deviates from an ideal or theoretical volume when the formation time is too short, for example, due to a very high pressure suddenly applied to the reservoir.Thus, when the droplet formation time is less than the first predetermined threshold, for example, 1 second, the processing system considers the amount of liquid dispensed to be significantly different from the optimal amount and therefore the distribution to be incorrect. Alternatively, the processing system can be configured to assign a correct distribution as long as liquid is dispensed, regardless of the droplet volume. In this case, the processing system can assign a correct distribution while still reporting a suboptimal droplet size. It is understood that the droplet formation time is the time. The time elapsed between the moment when no droplet formation begins and the moment the droplet detaches is measured. Since these two moments are difficult to detect, the measurement is taken of the time elapsed between the moment droplet formation begins (i.e., the start of the liquid presence detection step) and the moment the droplet detachment is detected by its absence due to its presence near the dispensing orifice (i.e., the end of the liquid presence detection step coinciding with the start of the liquid absence detection step). This applies throughout the description to any characteristic referring to the droplet formation time. Because the droplet formation time depends on the viscosity of the liquid product, the first predetermined time threshold is defined based on the viscosity of the liquid product used.

[00015] - The monitoring method includes a step in which the time elapsed between the start of the liquid presence detection step and the start of the liquid absence detection step is measured, and the processing system assigns an incorrect drop distribution when the elapsed time exceeds a second predetermined time threshold. Preferably, information corresponding to this incorrect distribution is made available to a user. || It is advantageous for the processing system to consider the drop distribution to be correct when the drop formation time is less than the second predetermined time threshold.Indeed, if the drop takes a long time to fall—that is, if drop formation exceeds the second predetermined time threshold—it can be assumed that the drop is not distributed to the receiving organ and that it is a residual drop eliminated afterward, for example, because the assistance device is not kept tilted long enough and / or the pressure exerted on the dispensing device to distribute the drop is too low. In this situation, the drop distribution can be considered invalid. By making this information readily available to the user, they can then be encouraged to dispense another drop to compensate for the deficiency.

[00016] - The two preceding embodiments can be combined. Thus, it is particularly advantageous for the processing system to consider the distribution of a droplet to be correct when the droplet formation time is between the first and second predetermined time thresholds. If the droplet formation time is greater than the first predetermined time threshold, the processing system can consider the volume of the detected droplet to be optimal, substantially equal to an ideal or theoretical volume, as explained previously. If in In addition to the fact that the drop formation time is shorter than the second predetermined time threshold, the treatment system can consider that the drop has been successfully delivered to the eye. Thus, through these comparisons with one or both of the first and second predetermined time thresholds, the monitoring process not only detects that a drop has indeed fallen, with the sequence "presence, absence," but also monitors that the drop fell with an optimal size and at the right time, therefore in the right place. This embodiment, in which comparison is made with the first and / or second predetermined time thresholds, is therefore particularly relevant.

[00017] - The monitoring method comprises the following steps: * a theoretical drop volume is determined, preferably based on the geometric characteristics of the dispensing orifice and the viscosity of the liquid product, and preferably also based on other characteristics of the dispensing device; * the time elapsed between the start of the liquid presence detection step and the start of the liquid absence detection step is measured; * this elapsed time is used to weight the theoretical drop volume and estimate the volume of the dispensed drop. In particular, the theoretical volume is weighted if the measured time is less than a first predetermined time threshold. Thus, the elapsed time can be used to estimate the volume of the dispensed droplet, and therefore the remaining dose. In particular, it is observed that for liquid products with relatively low viscosity, for example, less than 100 Cp, the volume of the dispensed droplet can be smaller when the droplet formation time is shorter. Conversely, for liquid products with higher viscosity, for example, greater than 100 Cp, the volume of the dispensed droplet can be larger when the droplet formation time is shorter. Therefore, to accurately determine the volume of the dispensed droplet, the theoretical droplet volume can be weighted by the measured time to obtain an estimated volume closer to the actual volume dispensed.Other characteristics of the dispensing device that can be taken into account in determining the theoretical volume may be chosen from: the resistance of the tank to the pressure exerted by the user, the flow limitation exerted by geometric shapes upstream of the dispensing orifice, the characteristics of a dispensing valve or other elements that may impact the relationship between the pressure exerted by a user on the tank and the drop of liquid product formed.

[00018] — The monitoring method includes a step in which the pressure exerted on a support area for activating a droplet dispensing mechanism is monitored, and the liquid product detection means are activated when the pressure exceeds a predetermined pressure threshold. The predetermined pressure threshold corresponds, for example, to the minimum pressure that must be exerted on the dispensing device to cause the formation of a droplet. By keeping the detection means inactive when the pressure is below the predetermined pressure threshold, their energy consumption is reduced without incurring the risk of failing to detect a droplet.Pressure is monitored, for example, using a pressure sensor which can be placed directly on a support area of ​​the assistance device or on a support area of ​​the dispensing device, or on an area designed to be attached to the dispensing device's reservoir and receiving a certain pressure when a drop of liquid is activated, or in any other area subjected to pressure when the user applies pressure to activate a drop of liquid. The threshold is, for example, 5 N or 15 N. A "support area" is defined as an area on which a user presses, either directly or via another element, to apply activation pressure to the reservoir in order to activate the dispensing of a drop of liquid. The support area can be located on the assistance device or on the dispensing device.

[00019] - The monitoring method includes a step in which the pressure exerted on a support area is monitored to activate a drop distribution, and the processing system assigns an incorrect drop distribution when the pressure is below a predetermined pressure threshold, preferably when the lower pressure is exerted for a duration exceeding a predetermined duration. Preferably, the processing system assigns an incorrect drop distribution when the pressure is below the predetermined pressure threshold at the beginning of the third detection step.Indeed, in the case of a dispensing device without droplet re-aspiration (a dispensing device that, after pressure release, does not re-aspirate a partially formed droplet), it is possible to form a droplet by applying several relatively low successive pressures, for example, by repeating pressures corresponding to the minimum pressure that must be applied to the dispensing device to induce droplet formation. The dispensing of a droplet can then be considered correct when this minimum pressure is applied at the beginning of the third detection stage. When the user applies pressure (i.e., force) to the contact area, it can thus be predicted that this pressure will exceed the predetermined pressure threshold, and preferably for a sufficient duration, to form and, more importantly, detach a droplet. Indeed, when the applied pressure is low, the detected sequence of "absence, presence, absence" can correspond with a certain probability to an incorrect dispensing. This might be due, for example, to a partially formed droplet detaching from the orifice because of unwanted agitation in a dispensing device without droplet re-aspiration, or to a partially formed droplet being re-aspirated back into the dispensing orifice in a dispensing device with re-aspiration. In both cases, the formed droplet will not be dispensed into the receiving organ, which is why the processing system considers the dispensing incorrect. Therefore, it is beneficial to be able to trigger an action such as alerting the user to an incorrect dispensing.We understand that in the case of non-re-aspiration drip delivery devices, the pressure applied to a support area required to deliver a correct drip distribution may be applied in several stages, for example, a first pressure below the predetermined pressure threshold, then a second pressure below the predetermined pressure threshold, but the sum of these two pressures being greater than the predetermined pressure threshold if each of the first and second pressures below the predetermined pressure threshold is nevertheless greater than a predetermined minimum pressure threshold. In this case, the treatment system can deliver a correct drip distribution, preferably if the first and second pressures below the predetermined pressure threshold are separated in time by a duration shorter than a predetermined duration.

[00020] - The monitoring method includes a step in which the displacement of a support area is monitored, preferably the duration of this displacement, for example by means of a first accelerometer mounted on the support area and a second accelerometer mounted on the reservoir of the dispensing device containing the liquid product. The processing system assigns an incorrect drop distribution when the displacement is less than a predetermined displacement threshold during the second detection step or when the duration of the displacement is less than a predetermined duration threshold. The displacement of the support area reflects the pressure exerted; therefore, by measuring it, the pressure exerted on the support area is indirectly measured, taking into account its mechanical resistance.Thus, by evaluating the displacement of the support zone, and preferably also the duration of this displacement, the processing system can determine whether a droplet has been successfully formed and dispensed. Furthermore, as with pressure measurement, the displacement of the support zone can also occur in several stages. In this case, the processing system considers the sum of these displacements, and preferably the sum of their durations, and preferably if these displacements are separated by a shorter interval. for a predetermined duration.

[00021] — During the liquid absence detection step, the absence of liquid is detected at a first distance from the dispensing orifice, and during a liquid presence detection step, simultaneous or subsequent to the liquid absence detection step, the presence of liquid is detected at a second distance from the dispensing orifice, the second distance being greater than the first distance. This liquid presence detection step is called the fourth detection step. The distance is defined in the direction from the dispensing orifice to the user's target device. Therefore, the absence of liquid is detected at a distance closer to the dispensing orifice than the presence of liquid.Thus, detecting the absence of liquid indicates that the drop has successfully left the dispensing orifice, while detecting the presence of liquid slightly further from the dispensing orifice indicates that the drop has been dispensed outside the orifice. In this way, the processing system detects when a drop is dispensed outside the dispensing device and eliminates, for example, cases where the drop is drawn back into the dispensing orifice. The liquid presence detection step, or fourth detection step, occurs simultaneously with the liquid absence detection step when the distance between the first and second distances is less than the drop size. The liquid presence detection step, or fourth detection step, occurs after the liquid absence detection step when the distance between the first and second distances is greater than the drop size.

[00022] — The monitoring method includes a step in which the inclination of the dispensing device is measured, and the processing system assigns an incorrect droplet distribution when the variation in inclination exceeds a predetermined value during the second detection step. Indeed, when the inclination of the dispensing device undergoes a significant change during droplet formation, the droplet is likely not being dispensed into the receiving organ. This is the case, for example, when the user makes a sudden movement of the dispensing device towards its vertical rest position during droplet formation. Advantageously, by combining the measurement of the inclination of the dispensing device and the measurement of the pressure exerted on a previously described support area, the processing system can perform a double validation of the droplet distribution.Indeed, this makes it possible to rule out, for example, the case in which the user exerts strong pressure on the dispensing device when the latter is in its vertical rest position or the case where the user keeps the dispensing device inclined without exerting any pressure. pressure on the dispensing device. In both cases, there is no correct droplet distribution. It is understood that it is possible to measure the acceleration of the dispensing device in the same way as its inclination, in order to take into account sudden movements without a change in inclination.

[00023] — The monitoring method includes a step in which the inclination of the dispensing device is measured, and the processing system deduces an estimate of the volume of the detected droplet. It is noted that the inclination of the dispensing device influences the volume of the droplet. More precisely, it is observed that the volume of the dispensed droplet increases with the angle of inclination of the dispensing device measured relative to the horizontal. Thus, by measuring this inclination, the processing system can weight a theoretical droplet volume to estimate the volume of the droplet actually dispensed. Furthermore, after obtaining the volume of the detected droplet, the processing system can optionally calculate a new value for the residual volume of liquid product in the dispensing device.

[00024] — The monitoring method comprises: * a step of determining the theoretical drop volume, preferably based on the geometric characteristics of the dispensing orifice and the viscosity of the liquid product, and preferably also based on other characteristics of the dispensing device, * a step of estimating the volume of the dispensed drop including a step of weighting the theoretical drop volume, during which at least one of the following parameters is taken into account for this weighting: the intensity of the activation pressure applied by the user on the reservoir to trigger droplet formation . the variation profile of this activation pressure over time, . the inclination of the assistance device and the distribution device, The duration of a disturbance in a signal provided by the detection means, - the measurement of the weight of the dispensing device. The theoretical volume preferably corresponds to a volume calculated from fixed data on the liquid product or the dispensing device, which do not vary according to the conditions of use of the latter. The fixed data can be determined by the information processing system, for example by reading the information carried by the dispensing device or by manual parameterization. By taking into account at least one of the parameters above, the calculated theoretical volume is adapted to the conditions of use of the dispensing device, which allows to obtain an estimate more in line with reality and therefore a more accurate determination accurate and reliable measurement of the quantity of liquid product dispensed.

[00025] — The monitoring method includes a step in which contact is detected between a bearing surface of a device assisting the use of the dispensing device and the subject's skin, and in which the processing system uses this information to assign a correct drop distribution, preferably when the contact detection is simultaneous with the beginning of the liquid absence detection step. The contact detection indicates that the receiving element is correctly positioned opposite the dispensing orifice. This ensures that a drop is dispensed at the desired location. This allows the system to prevent any drop distribution until contact is detected, to send information to the user, or to assign an incorrect drop distribution.

[00026] — The monitoring method includes a step in which the user is informed when the processing system does not receive the information corresponding to the sequence of the two steps of detecting the presence and absence of liquid, or when the processing system does not receive the information corresponding to the sequence of the three steps of detecting the absence of liquid, the presence of liquid, and the absence of liquid, or when the processing system assigns an incorrect drop distribution, for example, by a visual, audible, or tactile signal. By informing the user of an incorrect drop distribution, the user can, for example, dispense another drop to correct the previous incorrect distribution. The visual signal can be emitted by an LED or an alphanumeric display. The tactile signal can be in the form of vibrations.Alternatively or in combination, the user can be informed when the processing system receives information corresponding to the sequence of two or even three detection steps, or when the processing system assigns a correct droplet distribution.

[00027] — The method includes a step in which the weight of the dispensing device is measured to deduce the quantity of liquid product remaining in the device. Knowing the residual volume value obtained by measuring the weight, it is possible to deduce the quantity of liquid product dispensed. Thus, the weight measurement also allows validation of the estimated volume of the detected droplet or the translation of the quantity of liquid remaining into a theoretical number of remaining drops. The weight measurement step can be triggered conditionally based on the detected inclination, in particular based on maintaining a certain inclination of the device. dispensing device for a predetermined duration.

[00028] — For the cases presented above in which it is planned to measure the time elapsed between the beginning of the liquid presence detection step and the beginning of the liquid absence detection step, it is possible to alternatively measure the time elapsed in a time interval comprising another part of the liquid presence detection step and / or another part of the liquid absence detection step.

[00029] | The invention also relates to a device for assisting the use of a liquid product dispensing device in drop form for implementing the above monitoring method, comprising liquid product detection means, the processing system and at least one of the elements of the group comprising: - means for measuring the time elapsed between the start of the liquid presence detection step and the start of the liquid absence detection step, - means for measuring inclination, - means for detecting pressure on a support area, - means for detecting contact with a user's skin, - means for measuring weight, - means for indicating information to a user. Each of these means provides additional information to the treatment system to obtain information on droplet distribution, such as assigning a correct or incorrect distribution or quantifying the quantity of Liquid product dispensed or remaining.

[00030] | The invention also relates to a user assistance device of a device for distributing liquid product in the form of drops, comprising - means for detecting liquid product disposed in the vicinity of a drop distribution orifice, and - a system for processing the information provided by the detection means, the processing system being configured to provide information on the distribution of a drop, the liquid product detection means comprising first detection means configured to detect liquid at a first distance from the distribution orifice, and second detection means configured to detect liquid product at a second distance from the distribution orifice, the second distance being greater than the first distance. The first and second distances are defined in the direction from the dispensing orifice to the user's receiving device. Thanks to this assistance device, the detection means can detect the presence or absence of liquid, i.e., a drop, at two different distances from the dispensing orifice. Based on the result obtained by one of the first and second detection means, preferably obtained simultaneously by both, the processing system can deduce whether a drop of liquid product is formed, dispensed, remains, or is re-aspirated into the orifice.For example, if the first detection means detect the absence of liquid while the second detection means detect the presence of liquid, and the second detection means are further from the dispensing orifice than the first detection means, the processing system can deduce that a drop of liquid product has detached from the dispensing orifice.

[00031] The assistance device may further include means for blowing away residual droplets, for example by means of an air nozzle. Thus, if a residual droplet is detected, an airflow can be projected towards the dispensing orifice in order to expel the residual droplet from the end of the dispensing orifice.

[00032] We will now present specific embodiments of the invention given by way of non-limiting examples and in support of the accompanying figures in which: Figures 1A and 1B are perspective views of an assistance device according to one embodiment, Figure 1A representing the assistance device alone and Figure 1B representing the upper part of the entire assistance device and a distribution device attached to the assistance device, the assistance device being in the open position and the distribution device being provided with a protective cap for the distribution orifice, Figures 2A and 2B are schematic longitudinal cross-sectional views of different parts of the assembly shown in Figure 1B. Figure 3 is a set of three longitudinal cross-sectional views of the upper part of the distribution device shown in Figure 1B. Figure 4 is a graph showing information processed by the device assistance from figure 1A, Figure 5 is a graph showing the steps of a monitoring process according to a method of implementation.

[00033] Figure 1A illustrates an assistance device 10 for using a dispensing device 12 for a liquid product in drop form, the liquid product being contained in a reservoir of the dispensing device 12 (visible in Figure 1B). Figure 1B illustrates a dispensing kit comprising the assistance device 10 and the dispensing device 12 arranged inside the assistance device 10. The assistance device 10 includes means for securing it to the dispensing device 12 so that the assembly is fixed together. The securing means may include, for example, a snap-fit ​​mechanism for the dispensing device 12 into the assistance device 10.The assistance device 10 comprises a main body 14 into which the dispensing device 12 is placed, and a support structure 16 against the user's skin during the dispensing of drops into a target organ of the user (or subject), for example, an eye. The support structure 16 is, for example, removably mounted on the main body 14 between an open position for insertion of the dispensing device 12, visible in Figure 1B, and a closed position for use, for example by means of a hinge 18.The support structure 16 can be designed to be sufficiently flexible to ensure comfortable contact with the user's skin and to adapt to the contours near the target organ, and / or sufficiently rigid to provide support and impose a predetermined distance between the target organ and a dispensing orifice 20 (visible in Figures 2A and 2B) located in this example on the dispensing device 12, but which can be arranged in a variant on the assistive device 10. The support structure 16 includes an axial orifice 22 for allowing the passage of drops of liquid product from the dispensing orifice 20 to the user's organ. Optionally, the support structure 16 includes recesses 24 on two opposite sides and at its end, particularly to prevent the user's eye from being in darkness when the assistive device 10 is applied against the user's skin around their eye.The support structure 16 may have a closed or open contour, for example a C-shaped contour. The C-shaped contour allows, for example, the user to pass their finger through the opening of the C to pull down the lower eyelid, in order to open their eye further and ensure that the drop reaches the eye.

[00034] The assistance device 10 also includes a support area 26, intended both for gripping and for providing support to the user when dispensing the liquid product. The support area 26 is located on two opposite sides of the main body 14. Activation pressure exerted on the support area 26 is transmitted to the reservoir of the dispensing device 12, in particular at a contact area between the reservoir and the assistance device 10. The support area 26 may be made of a different material, in particular a more flexible one, than that of the rest of the main body 14. It It may also include raised features that facilitate gripping by the user. Furthermore, thanks to the presence of the support area 26, the assistance device 10 increases the user's gripping surface and the activation pressure on the reservoir compared to that of the dispensing device 12 alone, which is particularly advantageous for users with neuromuscular diseases.

[00035] The assistance device 10 includes liquid product detection means 28, 30, 36, 38 located in the vicinity of the dispensing orifice 20. Figures 2A and 2B show that these detection means include first detection means 28, 30 configured so that the detection of the presence of liquid is indicative of a drop in the process of formation, in contact with the dispensing orifice 20, and comprising optical means in the form of a transmitter 28 and a receiver 30 of an optical detection signal 32 (visible in Figure 3 and hereafter referred to as the optical signal 32) configured to detect the presence of liquid interfering with the optical signal 32 and to measure the duration of this presence. The transmitter 28 includes, for example, infrared emitting diodes, and the receiver 30 includes, for example, phototransistors capable of detecting infrared rays.The emitter 28 and receiver 30 thus detect the presence of a droplet passing through the optical signal 32 when the optical signal 32 is disturbed, for example by a variation in the intensity of this optical signal 32. The first detection means 28, 30 are preferably located at a distance of between 1 and 3 mm, preferably 2 mm, from the distribution orifice 20, detecting the presence of liquid in the detection zone located between the emitter 28 and the receiver 30 in the vicinity of the distribution orifice 20. The assistance device 10 advantageously includes second detection means 36, 38, comprising another pair of emitter 36 and receiver 38 located at a distance from the distribution orifice 20 greater than that of the first pair of emitter 28 and receiver 30. The operation of this second pair 36, 38 is similar to that of the first.Preferably, the second detection means 36, 38 are located at a distance of between 5 and 10 mm, for example close to 7 mm from the distribution orifice 20.

[00036] Furthermore, with a receiver 30, 38 of limited dimensions, it may be that, when the assistance device 10 is tilted, the passage of a drop is not detected by this receiver 30. To overcome this problem, the receiver 30, 38 may have a receiving zone for the optical signal 32 extending axially and / or circumferentially, the transmitter 28, 36 being configured to emit said optical signal 32 in the receiving zone, in order to guarantee the detection of the passage of a drop even when the assistance device 10 is tilted.

[00037] The assistance device 10 includes an information processing system 40, in particular for detection information provided by the detection means 28, 30, 36, 38. The processing system 40 is configured to provide information on the distribution of a droplet. The information processing system 40 is a system comprising a set of components (mechanical, electronic, chemical, photonic, and / or biological) capable of automatically processing information. It includes, for example, a printed circuit board (PCB), a set of transistors, and / or a computer.

[00038] | The assistance device 10 includes means 42 for measuring the duration of a drop's presence in the vicinity of the orifice, for example by measuring the duration of the signal disturbance from the detection means. The measuring means 42 include, for example, an electronic timer activated simultaneously with the detection means.

[00039] | The assistance device 10 further includes tilt measurement means 44 configured to provide information on the tilt of the distribution device 12 attached to the assistance device 10. In one example, the tilt measurement means 44 include an inclinometer such as an electronic gyroscope or an accelerometer. The tilt measurement means 44 are preferably located in the main body 14 or in the support structure 16, for example in an area intended to be located near the distribution port 20.

[00040] The assistance device 10 further includes means for measuring the activation pressure 46 exerted on a support area for the activation of a drop distribution, such as the support area 26, to trigger the detection means 28, 30, 36, 38 and / or provide information to the processing system 40. The means for measuring the activation pressure 46 can provide information on the intensity of the activation pressure applied to the support area and the duration of application of this activation pressure.The detection of this activation pressure can be direct, by measuring the pressure applied by the user to the support area 26 to activate the dispensing device 12, or indirect, for example, by measuring the pressure exerted on an area of ​​the assistive device 10 or the dispensing device 12 attached to the reservoir of the dispensing device 12 when the user activates the reservoir or another support area. In this second case, it may be the deformation of the reservoir that allows the activation of a drop dispensing, the activation pressure information being deduced from the way the reservoir is deformed. means for measuring activation pressure 46 include for example an FSR type pressure sensor, intended to be placed in contact with the reservoir of the distribution device 12, by being carried for example by the inner face of the assistance device.

[00041] The assistance device 10 includes contact detection means 48 for detecting contact with a user's skin, located on the support structure 16. The contact detection means 48 provide information to the treatment system 40 regarding the correct positioning of the target organ in relation to the distribution orifice 20 to ensure droplet distribution to the desired location. The contact detection means 48 can operate by optical principle (light sensor that detects the presence or absence of light on the surface of the support structure 16), by electrical principle (closure of an electrical circuit by the presence of skin), by mechanical principle, or by any other principle.

[00042] The assistance device 10 includes means for measuring the weight 50 of the dispensing device 12 attached to the assistance device 10, configured to provide information on the quantity of liquid product remaining in the reservoir of the dispensing device 12. The means for measuring the weight 50 include a weight sensor, for example a Force Sensing Resistor (FSR), disposed below or above the reservoir of the dispensing device 12, enabling the weight of the dispensing device 12 to be measured. From this weight, the weight of the liquid product in the reservoir, and therefore the volume, is deduced from the quantity of liquid product remaining. In one embodiment, the assistance device 10 has several weight sensors around the reservoir so as to be able to measure the weight of the dispensing device 12 attached to the assistance device 10 regardless of its inclination.

[00043] Advantageously, the assistance device 10 includes means 52 for indicating information provided by the processing system 40, for example, visual means 52, audible means, and / or tactile means. These include, for example, a display screen for information in alphanumeric form. In one embodiment, they further or alternatively include light-emitting diodes around the dispensing orifice 20 for providing a light signal to indicate, for example, correct or incorrect dispensing of a drop of liquid product.

[00044] Optionally, the assistance device 10 may also include means for blowing residual droplets, such as an air nozzle directed towards the distribution orifice 20.

[00045] The method of monitoring the distribution of a drop using the detection means 28, 30 arranged in the vicinity of the drop distribution orifice 20, and the system for processing the information provided by the detection means 28, 30, is now described. This monitoring method is illustrated in part by Figures 3 and 4.

[00046] Under normal operating conditions of the dispensing device 12, when a user applies pressure to the support area 26, a drop of liquid product is caused to form at the dispensing orifice 20.The detection means 28, 30 arranged in the vicinity of the distribution orifice 20 detect in a liquid absence detection step D1, referred to hereafter as the first detection step D1 (represented in Figure 3A), before drop formation, an absence of disturbance in the detection signal (by detecting, for example, a high-intensity infrared signal), meaning an absence of liquid and therefore of a drop in the detection area, and in a liquid presence detection step D2, referred to hereafter as the second detection step D2 (represented in Figure 3B), after the start of drop formation, a disturbance in the detection signal meaning the presence of liquid and therefore of a drop (by detecting a decrease in the intensity of the infrared signal).At the end of droplet formation, the droplet detaches from the dispensing orifice 20, and the detection signal disturbance disappears during a liquid absence detection step D3, referred to as the third detection step D3, shown in Figure 3C (the detection means 28, 30 again detect a high-intensity infrared signal). The detection means 28, 30 send this sequence of "absence, presence, absence" information to the processing system 40, which processes it to deduce the appearance and correct distribution of a droplet. If this "absence, presence, absence" sequence is not detected, the processing system 40 deduces that there is no correct droplet distribution, because no droplet has formed and / or the droplet has not detached from the dispensing orifice 20.

[00047] When the assistance device 10 includes secondary detection means 36, 38, an absence of liquid is detected during the third detection step D3 at the first distance from the dispensing orifice 20, thanks to the first detection means 28, 30, and simultaneously or successively, during a liquid presence detection step referred to hereafter as the fourth detection step, a liquid presence is detected at the second distance from the dispensing orifice 20, thanks to the secondary detection means 36, 38. As the absence of liquid is detected at a If the distance from the dispensing orifice 20 is less than the distance at which a presence of liquid is detected, the processing system 40 deduces that the drop has detached from the dispensing orifice 20 and has been correctly dispensed.

[00048] In the graph in Figure 4, curve C1 represents the disturbance of the detection signal as a function of time and curve C2 represents the pressure (i.e. the intensity of the force) exerted on the distribution device 12 as a function of time.

[00049] To obtain curve C1, in addition to measuring the disturbance by the detection means 28, 30, 36, 38, the duration of presence or absence of signal disturbance is also measured, representing the duration corresponding to each detection step. In particular, the elapsed time T between the beginning of the second detection step D2 and the beginning of the third detection step D3 is measured. The processing system 40 assigns an incorrect droplet distribution when the elapsed time is less than a first predetermined threshold T1, because the volume of the distributed droplet is considered to be different from a theoretical volume.When the elapsed time T exceeds a second predetermined time threshold T2, the treatment system assigns an incorrect distribution because it considers that the drop is probably not distributed to the target organ, as the drop may have detached while the user no longer had the dispensing device 12 in front of the eye. Thus, unless the treatment system 40 has received contrary information from other measurement or detection means related to the use of the dispensing device 12, when the elapsed time T is between a first predetermined time threshold T1 and a second predetermined time threshold T2 greater than T1, the treatment system 40 assigns a correct distribution. In each of these three cases, the user can be alerted by making corresponding information accessible via the indication means 52.

[00050] The duration T, which corresponds to the formation time of the liquid product droplet, can be used to estimate the volume of this droplet. To do this, a theoretical droplet volume is first determined, here based on the geometric characteristics of the distribution orifice 20 and the viscosity of the liquid product, and preferably also based on other characteristics of the distribution device 12. Then, the elapsed time T between the beginning of the second detection step D2 and the beginning of the third detection step D3 is measured, and this time is then used to weight the theoretical droplet volume and estimate the volume of the distributed droplet.

[00051] To obtain curve C2, the pressure exerted on the support area 26 of the distribution device 12 is monitored over time. When the pressure is lower at a predetermined pressure threshold P at the beginning of the third detection stage D3, or when pressure is exerted for a duration less than a predetermined duration, the processing system 40 assigns an incorrect drop distribution.

[00052] Alternatively, the pressure exerted on the support area 26 can be monitored to activate the liquid product detection means 28, 30, or other means of the assistance device 10, when the pressure exceeds a predetermined pressure threshold, a priori relatively low so that the detection means 28, 30, 36, 38 can detect the absence of a drop during the first detection step D1, before the start of the second detection step D2. Thus, the detection means 28, 30, 36, 38, or the other means of the assistance device 10, when not in use, can be put into standby mode. According to a variant of the monitoring method, the first detection step D1 can be replaced by a step for detecting the activation of a drop distribution, for example, following pressure exerted on a support area 26 or a certain inclination of the distribution device 12.In this case, the droplet can form before the activation of detection means 28, 30 and the first detection step D1 does not take place.

[00053] Alternatively, the inclination of the dispensing device 12 relative to the horizontal can be measured. When the change in inclination exceeds a predetermined value during the second detection step D2, meaning that the user makes a sudden movement of the dispensing device 12 attached to the assistance device 10 during the drop formation step, it can be assumed that the dispensing device 12 is in a position very different from the liquid product dispensing position, or that the drop fell due to agitation, and therefore that the situation is unfavorable for correct dispensing. In this case, the processing system 40 assigns an incorrect drop distribution.

[00054] The monitoring method further includes, or alternatively includes, a weighing step of the dispensing device 12 to determine the quantity of liquid product remaining in the reservoir. By comparing the weight obtained to the weight of the dispensing device 12 before drop dispensing, the processing system 40 can detect or validate the dispensing of a drop if there is a weight change.

[00055] Alternatively, contact between the bearing surface of the support structure 16 and the subject's skin can be detected, for example, by means of an electrical circuit that closes when the subject's skin allows two electrodes arranged on the bearing surface of the support structure 16 to be connected. When the processing system 40 receives a positive or negative information about the presence of contact, it can assign a correct or incorrect distribution of a drop, or even allow the distribution of liquid product only if contact is detected.

[00056] The user can be informed when the processing system 40 does not receive the information corresponding to the sequence of the three steps, or at least of the second detection step D2 and the third detection step D3, or when the processing system 40 assigns an incorrect drop distribution, for example by a visual, audible or tactile signal.

[00057] The quantity of liquid product dispensed can also be estimated by estimating the volume of each drop dispensed using the assistance device 10. To do this, a theoretical volume is first determined, for example, based on the geometric characteristics of the dispensing orifice 12 and the viscosity of the liquid product, and preferably based on other characteristics of the dispensing device 12. Then, the volume of the detected drop is estimated by weighting this theoretical volume, taking into account at least one of the parameters mentioned above, namely: - the intensity of the activation pressure applied by the user to the reservoir for to cause the formation of gout, - the variation profile of this activation pressure over time, - the inclination of the assistance device 10 and the distribution device 12, - the duration of a disturbance of a signal provided by the detection means 28, 30, 36, 38, - the measurement of the weight of the distribution device 12. To weight the theoretical volume, the information system calculates one or more coefficients from one or the combination of the above parameters and applies it by multiplication to the calculated theoretical volume.

[00058] An example of the steps in a monitoring method is described in Figure 5. The monitoring method begins with a first step E1 of detecting an activation pressure exerted by the user on the support area 26. When the detected activation pressure exceeds a predetermined threshold, for example 15 N, the detection means 28, 30 are then activated to detect a drop in a step E2. Other means of the support device 10 may also be activated at this time. The detection means 28, 30 monitor the drop formation area in the vicinity of the dispensing orifice 20 until they detect the presence of liquid. At step E3, corresponding to the second detection step D2, a timer is started at step E4 when the liquid is detected. Time is counted as long as the drop does not leave the formation zone monitored by the detection means 28, 30, and 36, and does not detach from the dispensing orifice 20. In step ES, the detection means 28, 30, 36, and 38 detect the absence of liquid during the third detection step D3, and a pressure test is performed. If, during this test, the pressure exerted on the support area 26 does not reach a predetermined pressure threshold, for example, 15 N, then it is considered that the drop did not detach due to optimal pressure, and the processing system 40 assigns an incorrect dispensing.If, during the test, the pressure exceeds the predetermined threshold, then the processing system assigns a correct dispensing (at step E6' unless the processing system 40 has received contrary information from other measurement or detection means related to the use of the dispensing device 12). The processing system 40 can also process information on the tilt of the dispensing device 12 attached to the support device 10 and / or information provided by the detection means 28, 30. For example, if there is no longer any disturbance in the optical signal but the processing system 40 receives information indicating a significant change in tilt, this means that the drop of liquid product has been dispensed in the wrong place, for example, it fell next to the dispensing orifice 20.Advantageously, if the processing system 40 still detects a disturbance of the optical signal 32 at step E4 after a predetermined time threshold, step E5 is launched and if the measured pressure is below the predetermined pressure threshold, then this means that there is a residual drop at the distribution orifice 20 and this is confirmed by the fact that we are still in the second detection step D2.

[00059] According to another embodiment not shown, the pressure test is carried out during the second detection step. If, during this test, the pressure exerted on the support area 26 does not exceed the predetermined pressure threshold for a predetermined duration, then the droplet is considered not to have detached due to optimal pressure, and the processing system 40 assigns an incorrect distribution.

[00060] | The invention is not limited to the embodiments presented and other embodiments will be obvious to a person skilled in the art.

Claims

Claims 1. Method for monitoring the dispensing of a drop by a dispensing device (12) of a liquid product in the form of drops, using liquid product detection means (28, 30, 36, 38) arranged in the vicinity of a drop dispensing orifice (20), and a system for processing the information (40) provided by the detection means (28, 30, 36, 38), monitoring method during which the processing system (40) receives information corresponding to the succession of the following steps: - a liquid presence detection step (D2), during which the detection means (28, 30, 36, 38) detect the presence of liquid in the vicinity of the dispensing orifice (20), the detection means being configured (28, 30, 36, 38) so that the detection of the presence of liquid is significant of a drop being formed, in contact with the dispensing orifice (20), - a liquid absence detection step (D3) during which the detection means (28, 30, 36, 38) detect the absence of liquid in the vicinity of the dispensing orifice (20), and the processing system (40) processes this successive detection information of presence and absence of liquid to provide information on the distribution of a drop.

2. Monitoring method according to the preceding claim, comprising, before the step of detecting the presence of liquid (D2), called the second detection step (D2), a step of detecting the absence of liquid (D1), called the first detection step (D1), during which the detection means (28, 30, 36, 38) detect the absence of liquid in the vicinity of the dispensing orifice (20).

3. Monitoring method according to claim 1, comprising, before the step of detecting the presence of liquid (D2), called the second detection step (D2), a step of detecting an activation of a drop dispensing, for example following pressure exerted on a support zone (26) or a certain inclination of the dispensing device (12).

4. Monitoring method according to any one of the preceding claims, wherein the detection means (28, 30, 36, 38) emit a detection signal (32) in the vicinity of the dispensing orifice (20), receive said emitted detection signal (32), and detect the presence of liquid by receiving a detection signal (32) disturbed with respect to a detection signal (32) received in the absence of liquid, the detection signal (32) preferably being an optical signal, for example an infrared ray.

5. Monitoring method according to any one of the preceding claims, during which the time elapsed between the start of the liquid presence detection step (D2) and the start of the liquid absence detection step (D3) is measured and the processing system (40) attributes an incorrect distribution of a drop when the time elapsed is less than a first predetermined duration threshold (T1), and preferably information corresponding to this incorrect distribution is made accessible to a user.

6. Monitoring method according to any one of the preceding claims, during which the time elapsed between the start of the liquid presence detection step (D2) and the start of the liquid absence detection step (D3) is measured and the processing system (40) attributes an incorrect dispensing of a drop when the elapsed time is greater than a second predetermined duration threshold (T2), and preferably information corresponding to this incorrect dispensing is made accessible to a user.

7. Monitoring method according to any one of the preceding claims, during which: - a theoretical drop volume is determined, preferably as a function of the geometric characteristics of the dispensing orifice (20) and the viscosity of the liquid product, and preferably from other characteristics of the dispensing device (12), - the time elapsed between the start of the liquid presence detection step (D2) and the start of the liquid absence detection step (D3) is measured, and - we use this elapsed time to weight the theoretical drop volume and estimate a volume of the distributed drop.

8. Monitoring method according to any one of the preceding claims, during which the pressure exerted on a support zone (26) is monitored for the activation of a drop dispensing and the liquid product detection means (28, 30, 36, 38) are activated when the pressure exceeds a predetermined pressure threshold.

9. Monitoring method according to any one of the preceding claims, wherein the pressure exerted on a support zone (26) is monitored for activation of a drop dispensing and the processing system (40) attributes an incorrect dispensing of a drop when the pressure is lower than a predetermined pressure threshold, preferably when the lower pressure is exerted for a duration greater than a predetermined duration.

10. Monitoring method according to any one of the preceding claims, during which the movement of a support zone is monitored, preferably the duration of this movement and the processing system (40) attributes an incorrect distribution of a drop when the elapsed time is less than a first predetermined duration threshold (T1), and preferably information corresponding to this incorrect distribution is made accessible to a user.

11. Monitoring method according to any one of the preceding claims, in which, during the step of detecting the absence of liquid (D3), the absence of liquid is detected at a first distance from the dispensing orifice (20), and during a step of detecting the presence of liquid, simultaneous or successive to the step of detecting the absence of liquid (D3), the presence of liquid is detected at a second distance from the dispensing orifice (20), the second distance being greater than the first distance.

12. Monitoring method according to any one of the preceding claims, during which the inclination of the dispensing device (12) is measured, and the processing system (40) attributes an incorrect drop dispensing when the variation in the inclination exceeds a predetermined value during the second detection step (D2).

13. Monitoring method according to any one of the preceding claims, during which the inclination of the dispensing device (12) is measured, and the processing system (40) deduces therefrom an estimate of the volume of the drop detected.

14. Monitoring method according to any one of the preceding claims, comprising: - a step of determining the theoretical drop volume, preferably as a function of the geometric characteristics of the dispensing orifice (20) and the viscosity of the liquid product, and preferably furthermore from other characteristics of the dispensing device (12) - a step of estimating the volume of the dispensed drop comprising a step of weighting of the theoretical drop volume, during which at least one of the following parameters is taken into account for this weighting: . the intensity of the activation pressure applied by the user to the reservoir to cause the formation of the drop, . the variation profile of this activation pressure over time, . the inclination of the assistance device (10) and the distribution device (12), . the duration of a disturbance of a detection signal provided by the detection means (28, 30, 36, 38), - measuring the weight of the distribution device (12).

15. Monitoring method according to any one of the preceding claims, during which contact is detected between a support surface of an assistance device (10) for using the dispensing device (12) and the skin of the subject and during which the processing system (40) processes this information to assign a correct dispensing of a drop, preferably when the contact detection is simultaneous with the start of the step of detecting the absence of liquid (D3).

16. Monitoring method according to any one of the preceding claims, during which the user is informed when the processing system (40) does not receive the information corresponding to the succession of the two steps of detecting the presence of liquid (D2) and the absence of liquid (D3), or even when the processing system (40) does not receive the information corresponding to the succession of the three steps of detecting the absence of liquid (D1), the presence of liquid (D2) and the absence of liquid (D1), or even when the processing system (40) assigns an incorrect drop distribution, for example by a visual, audible or tactile signal.

17. Monitoring method according to any one of the preceding claims, during which the weight of the dispensing device (12) is measured to deduce the quantity of liquid product remaining in the dispensing device (12).

18. Assistance device (10) for using a device (12) for dispensing liquid product in the form of drops for implementing a monitoring method according to any one of the preceding claims, comprising the liquid product detection means (28, 30, 36, 38), the processing system (40) and at least one of the elements of the group comprising: - inclination measuring means (44), - pressure detection means (46) on a support zone (26), - contact detection means (48) with the skin of a user, - weight measurement means (50).

19. Assistance device (10) according to the preceding claim, comprising means (42) for measuring the time elapsed between the start of the step of detecting the presence of liquid (D2) and the start of the step of detecting the absence of liquid (D3).

20. Assistance device (10) according to claim 18 or 19, comprising means for indicating information (52) to a user.

21. Assistance device (10) for using a device (12) for dispensing liquid product in the form of drops for implementing a monitoring method according to any one of claims 1 to 17, comprising the liquid product detection means (28, 30, 36, 38), the liquid detection means (28, 30, 36, 38) comprising first detection means (28, 30) configured to detect liquid at a first distance from the dispensing orifice (20) so that the detection of the presence of liquid is significant of a drop being formed, in contact with the dispensing orifice (20), and second detection means (36, 38) configured to detect liquid at a second distance from the dispensing orifice (20), the second distance being greater than the first distance.

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