Electronic module for a bottle of a mechanically pumped liquid ophthalmic product, comprising a module and a bottle, and a device for monitoring treatment adherence.

Abstract

The invention relates to an electronic module (22) for detecting and transmitting or recording data relating to the actuation of a mechanical pump of a bottle (1) of a liquid ophthalmic product. The electronic module (22) is independent of the bottle, to which it can be attached and fixed. The electronic module (22) comprises an actuator (28) configured to be driven in motion by the movement of the moving part, and a sensor configured to be actuated by the movement of the actuator (28). This electronic module makes it possible to characterize user compliance with a treatment regimen. The invention also relates to an assembly comprising such a module installed on a bottle, and to a treatment compliance monitoring device further comprising computer equipment capable of communicating with the electronic module (22). Figure for the abstract: Fig. 6

Description

Title of the invention: Electronic module for a bottle of a liquid ophthalmic product with a mechanical pump, an assembly comprising a module and a bottle, and a device for monitoring treatment adherence.

[0001] The present invention relates to the field of distribution of ophthalmic products, including pharmaceutical solutions and other liquid ophthalmic preparations, in particular eye drops.

[0002] The invention relates in particular to the field of devices used to deliver ophthalmic drops from a reservoir using a mechanical pump. The present invention thus relates to liquid dispensing bottles, and more particularly to dispensing bottles equipped with a pump system to prime the dispensing of this liquid.

[0003] The principle of such sprayers has been described in document FR-2 739 294, in an application to nasal spray.

[0004] Document WO 2010 / 139883 filed by the Applicant discloses the use of such a sprayer for an ophthalmic application, with ergonomics adapted for this use.

[0005] Indeed, in this type of bottle, a pump mechanism is used in a known manner which is activated by pressing a moving part of the device.

[0006] In order to design a bottle with optimal ergonomics, which facilitates handling and allows the necessary force to be applied to the moving part to activate the pump, it is known to equip it with a cap to assist in the operation of the moving part and thus the pump. Such a cap has a cylindrical body that covers at least part of the bottle's reservoir and has a flat upper wall at its apex, pierced in its center to allow the passage of the bottle's dispensing nozzle. When the cap is in place on the bottle, the upper wall rests against the moving part of the pump. This increases the area on which pressure is applied to activate the pump and facilitates its long-term operation.

[0007] Different variants of caps can be used with the bottle to facilitate the actuation of the pump, taking for example the form as claimed in document WO 2010 / 139883 filed by the Applicant, which describes a two-part cap adapted to slide towards each other parallel to the axis of the pump and which each have a lateral gripping fin, which further facilitates the actuation of the pusher parts.

[0008] In this context, the Applicant also filed document WO 2014 / 170736, which proposes a liquid dispensing bottle with a cap that allows for simple and effective marking to warn the user of the first use of the bottle, i.e. allowing the user to see whether the bottle has already been opened or not, in order to facilitate the storage of bottles according to the recommendations for use.

[0009] Furthermore, the effectiveness of many ophthalmic treatments depends on several parameters, including adherence to the treatment dosage, and, in particular for bottles with a mechanical pump, the correct orientation of the bottle when instilling the liquid ophthalmic product.

[0010] In order to control the position of a bottle of ophthalmic product, with the aim of ensuring a correct instillation position, mechanical guides which impose a correct position on the bottle by application around the eye are known, for example through documents JP2003310710 and JP2008295880. These systems are nevertheless not very pleasant.

[0011] Document EP2912460 discloses a bottle incorporating a position sensor used to activate an optical drop sensor. When the bottle is correctly positioned, the device automatically triggers the product delivery control means. This system is complex, does not involve a mechanically pumped bottle, and does not allow the user to select the instillation time.

[0012] In addition to the aforementioned problems, the issue of monitoring adherence to dosage remains unresolved in the prior art. Furthermore, this strict monitoring of dosage adherence is not necessary for all treatments or for all patients, but can, on the contrary, be useful over a fairly long period during which several bottles of an ophthalmic product are used successively.

[0013] The present invention thus aims to provide a device to solve all or part of the aforementioned problems.

[0014] To this end, the invention proposes an electronic module for detecting and transmitting and / or recording data relating to the actuation of a mechanical pump of a bottle of a liquid ophthalmic product comprising a main body including a reservoir, a dispensing head and a mechanical pump, the dispensing head being mounted on the main body, the dispensing head including a movable part whose movement actuates the mechanical pump to draw the liquid ophthalmic product present in the reservoir,

[0015] characterized in that said electronic module is independent of said bottle to which it can be related, said module comprising an actuator configured so as to be driven into motion by the movement of the moving part, said module comprising a sensor configured so as to be actuated by the movement of the actuator.

[0016] An independent electronic module, designed to be attached to a bottle of ophthalmic product, offers numerous advantages. It allows a bottle to be equipped only when necessary. For example, when the patient has difficulty adhering to the prescribed dosage, or at the start of treatment when it is necessary to ensure that the dosage or other product administration parameters are correctly followed. Furthermore, the electronic module can be transferred from one bottle to another, in order to monitor a user's treatment over a longer period (exceeding the treatment duration provided by a single bottle). Finally, it is economical, as the module can be offered for a wide range of products without requiring different bottle ranges for each product and depending on whether transmission or storage of bottle actuation data is desired.

[0017] The module can be adapted in particular to a bottle in which the moving part is movable in axial translation relative to the main body. The sensor can be a contactor, the actuator being guided in translation along said axial direction and comprising a first bearing surface on the moving part and a second bearing surface on the contactor.

[0018] The actuator can be in the form of a rod extending along the axial direction, the rod having a first end forming the first bearing surface, and a second end, opposite to the first end, forming the second bearing surface.

[0019] The electronic module may include a spring tending to return the actuator to a rest position. The contactor is then advantageously open when the actuator is in the rest position.

[0020] A contactor is a simple and economical device that provides reliable information on the actuation of the pump in a mechanically pumped bottle. Furthermore, a contactor is relatively easy to implement with such a bottle because the axial actuation of the pump can be used to generate axial pressure on the contactor. A contactor also has the advantage of acting as a switch for the module, so that the module only consumes electrical energy, supplied by a battery, when the contactor is closed.

[0021] The electronic module may include a housing forming an internal volume for receiving at least one electronic card, said housing having a base and a cover, said base having an opening allowing the passage of the actuator.

[0022] The electronic module is thus properly protected from the external environment, with only the actuator protruding from the housing. In some embodiments, the housing cover may be removable, but it will more generally be fixed, for example, sealed during module assembly. The electronic module is maintenance-free. In preferred embodiments, it may, in particular, be equipped with a battery allowing the module to be powered for, for example, several weeks, several months, or even several years.

[0023] The electronic module may include at least one accelerometer configured to provide orientation information for the electronic module.

[0024] An accelerometer allows the orientation of the bottle equipped with the module to be characterized. The orientation of the bottle during product dispensing is important. In particular, for a mechanically pumped bottle with axial actuation, it is generally necessary for the bottle to be vertical when instilling the product into the eye. Instillation remains correct within a relatively limited angle range around the vertical, whereas an incorrect tilt of the bottle can lead to poor instillation (insufficient quantity of product delivered or received by the eye, imprecise drop point, etc.).

[0025] The orientation of the bottle during the distribution of the product is therefore an important parameter in the compliance of a treatment, and this information can be used to qualify compliance, and / or for teaching the user how to correctly use the bottle.

[0026] The electronic module may include an electronic memory adapted to store data relating to the actuations of the actuator, including the number, date and time of the actuations.

[0027] The measured data thus include the basic data to control adherence to treatment.

[0028] The electronic module may include a communication port, wired or wireless, suitable for transferring data to external computer equipment.

[0029] The electronic module can in particular be adapted to transfer data to external computer equipment according to a Bluetooth™ protocol.

[0030] Wireless transmission of the data measured and / or collected by the module allows the electronic module to interface with an external system, which enables the processing and visualization of the data. This may involve monitoring proper adherence to treatment by the patient or their doctor, or teaching the user how to perform correct, and therefore effective, instillations of the ophthalmic product.

[0031] The invention also relates to an assembly comprising a bottle of liquid ophthalmic product and an electronic module as previously defined. The bottle comprises a main body including a reservoir and a base, a dispensing head, and a mechanical pump. The dispensing head is mounted on the main body. The dispensing head includes a movable part whose movement actuates the mechanical pump to draw the liquid ophthalmic product from the reservoir. The electronic module is attached to and fixed either to the main body or to the dispensing head, such that the movement of the movable part relative to the main body to collect the liquid ophthalmic product present in the reservoir drives the actuator of the electronic module into motion.

[0032] The moving part of such a bottle can be movable in axial translation relative to the main body. This bottle can include a delivery assistance device, the main body comprising a first part of the delivery assistance device which cooperates with the reservoir, the first part of the delivery assistance device comprising a first lateral fin, the dispensing head comprising a second part of the delivery assistance device which cooperates with the moving part, the second part of the delivery assistance device comprising a second lateral fin, the first fin and the second fin being substantially opposite each other to allow axial movement of the moving part when a force is exerted between the two fins tending to bring them axially closer together.

[0033] In such an assembly, during the axial movement of the moving part, the actuator can bear on, and be actuated by, the second part of the delivery assistance device.

[0034] In particular, the first lateral fin may have a hole through which the actuator of the electronic module passes, said actuator bearing during the axial movement of the moving part on a radial protrusion of the second part of the delivery assistance device.

[0035] The electronic module that is the subject of the present invention can thus form, in association with a pre-existing type bottle, a bottle of ophthalmic product allowing the collection of data relating to the compliance of a treatment, or even a connected bottle.

[0036] The proposed electronic module does not require the development of a new pump bottle. It is particularly suitable for equipping a mechanical pump bottle with a dispensing assistance device, of a type already marketed by the Applicant.

[0037] The invention also relates to a device for monitoring adherence to a therapeutic treatment, comprising an electronic module as defined above of the type comprising a communication port, and external computer equipment adapted to communicate with said electronic module, the electronic module being configured to transmit data relating to the actuation of the actuator to the computer equipment, the computer equipment running software allowing temporal monitoring of the actuations of the actuator of the electronic module, which correspond to a delivery of the ophthalmic product.

[0038] In such a device, the computer equipment running the software allows for the recording of a dosage and the provision to the user of a comparison between the recorded dosage and the data relating to the actuation of the electronic module actuator transmitted to the computer equipment.

[0039] The invention thus proposes a complete solution allowing comparison of the treatment actually followed by the patient with the dosage prescribed to him.

[0040] In such a device for monitoring adherence to a therapeutic treatment, the electronic module being of the type defined above comprising an accelerometer, the module can be configured to transmit data relating to its orientation, and the computer equipment allows the user to view information as to the correct or incorrect orientation of the electronic module, and therefore in correspondence with a bottle equipped with said electronic module, during the actuations of the actuator.

[0041] In such a device, the computer equipment running the software can be adapted to emit in real time a signal indicating that the module has a correct orientation for the distribution of liquid ophthalmic product by a bottle equipped with said electronic module.

[0042] The computer equipment running the software can, in certain embodiments, calculate an compliance score based on the data transmitted by the module and indicate it to the user.

[0043] The invention thus allows the user to check that their instillation technique is correct. If not, the user can also correct it to improve the effectiveness of their treatment. The instillation timing data can be combined with data characterizing the instillation technique to calculate a "score" or "rating," which the user will naturally seek to improve during their treatment. The device thus has an educational, even playful, effect for the user.

[0044] The computer equipment can, for example, be a smartphone or a tablet, and the software is then an application.

[0045] Other features and advantages of the invention will become apparent in the following description.

[0046] To the attached drawings, given by way of non-limiting examples:

[0047] [Fig-1] Fig. 1 represents, in a schematic view, a bottle of product ophthalmic liquid comprising a mechanical pump, in a first configuration;

[0048] [Fig.2] Fig.2 represents, in a schematic view, the bottle of Fig.1 in a second configuration;

[0049] [Fig.3] [Fig.3] represents, in a schematic view, a bottle of product ophthalmic liquid comprising a delivery assistance device;

[0050] [Fig.4] [Fig.4] represents, according to a schematic three-dimensional view, the bottle of the [Fig.3];

[0051] [Fig. 5] [Fig. 5] represents, according to a schematic three-dimensional view, a electronic module conforming to an embodiment of the invention;

[0052] [Fig.6] [Fig.6] represents, according to a schematic three-dimensional view, the module of [Fig.5] installed on the bottle of [Fig.3];

[0053] [Fig.7] [Fig.7] represents, according to a detailed three-dimensional cross-sectional view partial, the whole of [Fig.6];

[0054] [Fig.8] [Fig.8] represents, according to a schematic three-dimensional view, another electronic module installed on a bottle similar to that in figures 3 and 4;

[0055] [Fig.9] [Fig.9] represents, according to a schematic three-dimensional view, a electronic module according to another embodiment of the invention installed on a bottle similar to that of figures 3 and 4;

[0056] [Fig. 10] [Fig. 10] represents, according to a schematic representation, an example of a first part of an application interface that can be implemented in the invention;

[0057] [Fig. 11] [Fig. 11] represents, according to a schematic representation, an example of a second part of an application interface that can be implemented in the invention;

[0058] [Fig. 12] [Fig. 12] represents, according to a schematic representation, an example of a third part of an application interface that can be implemented in the invention;

[0059] [Fig. 13] [Fig. 13] represents, according to a schematic representation, an example of a fourth part of an application interface that can be implemented in the invention.

[0060] Figure 1 shows a bottle of liquid ophthalmic product comprising a mechanical pump. Such a bottle is known in the prior art for dispensing a liquid nasal or ocular product. The bottle 1 comprises a main body 2 and a dispensing head 3. The main body 2 forms a reservoir 4, intended to contain a liquid product, for example, a liquid ophthalmic product. The dispensing head 3 has a nozzle 5, having at its end a dispensing orifice through which the liquid product is dispensed. The dispensing head 3 comprises a movable part 6 and a fixed part 7. The fixed part 7 being rigidly connected to the main body 2 of the bottle 1, the movable part 6 is movable relative to said main body 2. More specifically, the movable part 6 can be translated along an axial direction, determined by the principal axis A of extension of the bottle 1.In particular, bringing the moving part 6 closer to a base 8 of the main body activates a mechanical pump contained within the bottle. Activating the mechanical pump draws liquid from the reservoir 4 and dispenses it through the dispensing nozzle 5. To assist the user in operation... the pump, that is to say to bring the moving part 6 closer to the bottom 8, the moving part 6 has a collar 9 forming a support plane substantially orthogonal to the axial direction of actuation.

[0061] Fig. 1 represents bottle 1 in a resting configuration, which it tends to adopt in the absence of actuation.

[0062] [Fig.2] represents the bottle 1 of [Fig.1] in an actuation configuration, i.e. when the moving part is actuated by the creation of a force tending to bring it closer to the bottom 8. Such a force is obtained for example by pinching between the fingers of one hand of the user, positioned on the bottom 8 and under the collar 9. When the actuation configuration of [Fig.2] is reached, a drop 10 or a jet of product is delivered by the nozzle 5 of the bottle 1.

[0063] The bottle in Figures 1 and 2 constitutes a first example of a bottle to which the present invention can be applied.

[0064] Figures 3 and 4 represent a bottle of liquid ophthalmic product incorporating a dispensing assistance device. Indeed, the bottle in Figures 1 and 2 can prove difficult to operate, particularly when dispensing an ophthalmic product, as such dispensing requires precise positioning of the bottle.

[0065] Good positioning is achieved by improving the overall ergonomics of the bottle and facilitating the application of the force necessary for its actuation.

[0066] The principle developed in the bottle of figures 3 and 4 consists of equipping the bottle 1 with at least two lateral fins, substantially orthogonal to the axial direction of actuation of the pump and of the bottle 1.

[0067] In particular, the bottle 1 has a first lateral fin 11 for holding the fixed part 7 of the bottle 1 in position and a second lateral fin 12 for moving the movable part 6 of the bottle 1 along the axial direction. More generally, the approach between the first lateral fin 11 and the second lateral fin 12 along the axial direction actuates the mechanical pump of the bottle 1.

[0068] The first lateral fin 11 and the second lateral fin 12 are substantially opposite each other, in two axially distant planes. This facilitates the application of a force tending to bring them closer together. In the example shown here, the first lateral fin and the second lateral fin are substantially of identical length. Other fin configurations can be used and are compatible with the present invention.

[0069] In practice, the bottle in Figures 3 and 4 may include the bottle in Figures 1 and 2, to which a cap is added to facilitate pump operation. In particular, the bottle in Figures 1 and 2 is shown in dotted lines in the [Fig.4], installed in a two-part cap forming a delivery assistance device.

[0070] Thus, the main body of the bottle in Figures 3 and 4 comprises a first part of the delivery assistance device 13 including the first lateral fin 11, which is attached to the reservoir in Figures 1 and 2. In particular, the first part of the delivery device 13 forms the bottom 8 of the bottle 1. The first part of the delivery assistance device 13 can be configured (except for the first lateral fin 11) essentially in the form of a tank whose internal shape is adapted to receive the reservoir 4.

[0071] The dispensing head 3 of the bottle in Figures 3 and 4 comprises, in addition to the fixed part 7 and the movable part 6, a second part of the delivery assistance device 14. The second part of the delivery assistance device 14 comprises the second lateral wing 12. The second part of the delivery assistance device 14 is (except for the second lateral wing 12) essentially in the form of a barrel comprising a proximal area of ​​the bottom 8 cooperating with the first part of the delivery assistance device 13 and a distal rim 18 of the bottom 8 which bears against the collar 9 of the movable part 6 of the dispensing head.

[0072] The first part of the delivery assistance device 13 and the second part of the delivery assistance device 14 are, in the example shown, guided in axial translation relative to each other by means of a groove 15 of the second part of the delivery assistance device 14 in which a pin 16 of the first part of the delivery assistance device 13 is guided. A radial protrusion 17 of the second part of the delivery assistance device prevents the pin 16 from coming out of the groove 15.

[0073] The tip 5 of the bottle 1 protrudes from the distal open end 19 of the second part of the delivery assistance device 14. In figures 3 and 4, the bottle 1 is shown equipped with a cap 20 which closes and protects the tip 5. Other cap configurations are obviously known, including one with a visual indicator of first opening.

[0074] The bottle in Figures 3 and 4 constitutes a second example of a bottle to which the present invention can be applied, and constitutes a preferred application thereof.

[0075] As shown in [Fig. 4], the bottle 1 has a minor optional adaptation (compared to the commercially available bottle in the prior art) allowing the use on this bottle of an electronic module forming a preferred embodiment of the invention. This adaptation consists of forming a hole 21 in the first lateral fin 11, in the immediate vicinity of the wall of the main body 2 of the bottle 1, the use of which is explained below.

[0076] Figure 5 shows an electronic module 22 according to an embodiment of the invention. The electronic module 22 comprises one or more electronic boards 23, mounted in a housing 24. The housing comprises, in the example shown, a base 25 and a cover 26. Typically, the base 25 may include retaining and receiving pads for the electronic board 23. Once the electronic board 23 is positioned in the base, the housing is closed by placing the cover 26 on top. The cover 26 is advantageously (but not necessarily) sealed to the base 25, making any subsequent opening impossible. Fuse pads may be used to achieve this seal.

[0077] The base 25 has an opening 27 through which an actuator 28 extends from the housing 24. Since the shape of the opening corresponds to that of the actuator 28, the actuator 28 is, in the example shown, perfectly guided in translation within the opening 27. In this case, the actuator 28 is in the form of a cylindrical rod. A spring 29, in this case a helical spring, tends to return the actuator to a rest position in the absence of any external force applied to the actuator 28.

[0078] The electronic module 22 includes a sensor intended to be activated by the axial movement of the actuator 28. Advantageously, the sensor is a contactor. Thus, the rod-shaped actuator 28 of the embodiment shown here has, at its first end located outside the housing 24, a first bearing surface 30. The first bearing surface 30 is intended to come into contact with and bear against a moving part 6 of the distribution head. The rod-shaped actuator 28 has, at its second end located inside the housing 24, a second bearing surface 31, intended to come into contact with and press against the contactor. Thus, the second bearing surface 31 causes the contactor to press against or release when a force is applied to the first end 30 of the actuator 28, provided that this force is sufficient to compress the spring 29, and that the movement imposed on the actuator 28 has a sufficient amplitude.

[0079] Thus, in the rest position of the actuator 28, the contactor is open, while when the actuator is pushed into the housing, the contactor is closed. Depending on the contactor technology and the configuration of the electronic module 22, the contactor may be closed by pressing or releasing pressure on it.

[0080] The electronic module 22 includes an electrical power source, in the form of a cell or battery. A cell can provide the sensor with a very long operating time, lasting several weeks, several months, or even several years of processing. In particular, when the electronic module 22 includes a switch as a sensor, the electronic module 22 can be configured to consume energy only when the sensor is actuation. For example, when the sensor is closed corresponding to the detection of an actuation of the actuator, and therefore of the bottle on which it is mounted, can lead to the power supply of the electronic module 22.

[0081] Fig. 6 represents the module of Fig. 5 installed on the bottle similar to that of Figures 3 and 4. The bottle shown in Fig. 6 differs only from that of Figures 3 and 4 in that the cap 20 is of a different shape and has a ring 32 allowing visualization whether the bottle has already been opened or not.

[0082] In the example shown here, the electronic module 22 is attached to the base 8 of the bottle 1 by matching shape and by clipping onto the first lateral fin 11. Clipping the electronic module 22 onto the first part of the delivery assistance device 13 makes these two elements joined and fixed to each other. For this purpose, the base 25 of the housing 24 is provided with a notch 33 forming two fixing tabs 34 adapted to lock under the first lateral fin 11.

[0083] The actuator 28 passes through the hole formed in the first lateral fin 11. When the bottle is actuated by bringing the first lateral fin 11 and the second lateral fin 12 together in the axial direction (parallel to the main axis A of the bottle), the first bearing surface 30 of the actuator comes into contact with the radial protrusion 17 of the second part of the delivery assistance device 14. As the movement of the electronic module relative to the radial protrusion 17 continues, the latter applies a reaction force on the actuator 28, which pushes the actuator into the housing 24. The contactor of the electronic module 22 is then activated.

[0084] Obviously, fixing the module to the main body of the bottle, in a location other than its base and / or by a means other than clipping, is conceivable without going out of the scope of the invention.

[0085] The electronic module can, in particular, be configured so that its housing is installed on the side, and not at one end, of the equipped bottle. This limits the increase in bottle length associated with the installation of the electronic module.

[0086] Activation of the contactor (or other sensor) of the electronic module 22 causes either the recording of data relating to this activation, or the wireless transmission of this data, or both. The data may be recorded on a memory that the electronic module 22 may have.

[0087] Data transmission, in real time or at specific times after recording, is advantageously carried out wirelessly, for example using a Bluetooth™ protocol, advantageously Bluetooth Low Energy™. For this purpose, the electronic module 22 is equipped with a wireless communication system, including a wireless communication port for data transfer. In an alternative embodiment, communication via a wired port may be used.

[0088] In the embodiment of [Fig. 7], a contactor 35 is under pressure from the second bearing surface 31 of the actuator 28, by the effect of the spring 29, when the actuator is in its rest position. The movement of the actuator 28 when it bears, via the first bearing surface 30, on the radial protrusion 17 of the second part of the delivery assistance device 14, releases the pressure exerted on the contactor 35 by the second bearing surface 31, which causes the contactor to close, and the actuation of the bottle to be detected.

[0089] The actuation data can be of various kinds. The first type of data relates to the actuation information itself. This information can be associated with temporal information, typically the date and time of the detected actuation, or information relating to the time elapsed since the previous actuation. The actuation information can be accumulated over time in order to determine the number of actuations during a single dose (during an instillation sequence), or the total number of actuations.

[0090] The module may include one or more accelerometers. Alternatively or in addition, other position and orientation sensors, particularly gyroscopes, may be used. The accelerometer determines the orientation of the electronic module in space, and in particular its orientation relative to the vertical. For correct instillation, the bottle must be vertically oriented, meaning that the principal axis A of the bottle must be aligned with the vertical, or at least within a given range of angles around the vertical. This information is determined using the accelerometer at the moment the bottle is actuation and can be combined with actuation data, including time information.

[0091] The electronic module can thus, in certain embodiments, determine when an instillation has been carried out, how many drops of product were delivered on that occasion, and what the orientation of the bottle was for each drop delivered.

[0092] Figure 8 shows another electronic module installed on the bottle in the figures 3 and 4. This embodiment differs from that of Figures 5 to 7 in that the base 25 of the housing 24 of the electronic module 22 has larger clipping tabs 34 on the first lateral fin 11, which extend partially laterally under said first lateral fin 11. The optional convex shape of the first lateral fin 11 allows for easy clipping by axial pressure on the module 22, this pressure and said convex shape having the effect of spreading the tabs 34 apart. Removing the electronic module 22, for example to install it on another bottle, is done by spreading the tabs 34 apart, which releases the tabs of the first lateral fin 11. The module is then secured. electronic 22 is thus made more reliable, and the play between the electronic module 22 and the bottle is limited.

[0093] The invention has been illustrated in Figures 5 to 8 according to embodiments in which the electronic module 22 is fixed to the main body 2 of the bottle. Similarly, fixing the electronic module 22 to the dispensing head 3 is possible, in a configuration of the electronic module 22 in which the relative movement between the main body 2 and the moving part 6 allows the actuation of said electronic module 22. Such an embodiment is illustrated in [Fig. 9].

[0094] More specifically, in the embodiment shown in [Fig. 9], the electronic module 22 is clipped onto the dispensing head on the second part of the delivery assistance device 14, which cooperates with the moving part 6. To this end, the electronic module 22 is provided with two wide fixing tabs 34 that grip the end part of the second part of the delivery system 14. The housing 24 of the electronic module 22 covers, in the example shown here, the groove 15 and the pin 16 of the first part of the delivery system 13, which is guided in the groove 15. The pin 16 can be used to actuate the actuator of the electronic module (not visible in [Fig. 9], as it is located on the face of the housing 23 that is in contact with the bottle 1).The movement of the pin 16 in the groove 15, which translates the movement of the movable part 6 relative to the main body 2, causes the movement of the actuator of the module 22 and results in the instillation of product by the bottle.

[0095] The transmission, in real time or otherwise, of data from the electronic module allows for the monitoring of product instillation parameters and treatment adherence. The transmission is carried out to a computer device, for example, a computer, a server, a tablet, or a smartphone. The computer device runs software that retrieves, processes, and displays the data (raw or processed) from the electronic module 22 (or from several modules).

[0096] Figures 10 to 13 represent various parts of an application running on a smartphone connected to the electronic module 22. These different parts illustrate, by way of example, different functionalities that can be offered by the electronic module 22 and the application running.

[0097] Figure 10 represents a "calendar" panel 36 dedicated to monitoring adherence to treatment over time. According to the dosage indicated elsewhere in the application (see Figure 12 described below), this calendar panel 36 provides an overview of treatment adherence over time. The calendar panel can, in particular, offer a monthly view 37 (or alternatively, a weekly, two-week, etc.). For each day, a rectangle is displayed corresponding to a planned instillation (for example, for a morning instillation and an evening instillation, two rectangles are shown for each day). For correctly performed instillations, a visual indicator, here in the form of a white rectangle, is displayed. Of course, other indicators and / or other colors can be used. In particular, a green indicator is spontaneously associated with a positive action and can therefore advantageously represent a correct instillation. By correct instillation, we mean the detection of an actuation of the bottle within a given time range, or, where applicable, several actuations of the bottle corresponding to the number of drops to be delivered, and / or the detection, within the given time range, of the correct orientation of the bottle.

[0098] Conversely, an incorrect instillation is represented by a different indicator, here a hatched rectangle. Of course, other indicators and / or other colors can be used. In particular, a red indicator is spontaneously associated with a negative effect and can therefore advantageously represent an incorrect instillation.

[0099] An action (click, point, press) on a day of the monthly view 37 allows the display of details on the instillations of that day, in a detail area 38. The detail area can for example provide the exact time of delivery of each drop, other information such as whether or not the interval provided for in the treatment dosage was correctly respected, or various information related to possible errors in the system, measurement, etc.

[0100] Figure 11 represents an "education" panel 39, dedicated to monitoring and teaching the user the correct instillation technique. In certain embodiments, this panel indicates whether an insertion has been performed with the bottle correctly oriented, i.e., with its principal axis A correctly aligned with the vertical. The result can be displayed in real time, immediately after the bottle is activated, allowing the user to correct the bottle's position for the next insertion.

[0101] Different views concerning past instillations may be available in this panel. In the example shown here, a daily view 40 indicates the number of instillations performed with the correct orientation and the number of instillations performed with the incorrect orientation during the current day. In the example shown, a weekly view 41 provides information on the proportion of instillations performed with the correct orientation and the proportion of instillations performed with the incorrect orientation over the current week, or over a rolling week, or more generally over several days. The distribution is, for example, represented for each day by a histogram, with instillations performed with the correct orientation represented by a white bar, and instillations performed with the incorrect orientation by a black bar. Incorrect orientation is represented by a hatched bar. Other indicators and / or colors (e.g., green and red) may be used. Other categories may be illustrated, for example, instillations performed with a borderline or uncertain orientation (e.g., represented by an orange indicator).

[0102] One of the objectives of this educational component 39 is to enable the user to check whether the orientation given to the bottle when instilling eye drops is acceptable, and to correct this orientation if necessary throughout their treatment.

[0103] Figure 12 represents a "treatment" panel 42, dedicated to visualization and, where applicable, dosage determination. In particular, this panel can be used to program the treatment dosage, which will be used by the other panels.

[0104] This panel also includes a dosage reminder 43. It also features a dosage control area, which indicates the number of drops dispensed compared to the desired dosage, and whether the interval between two instillations is being observed (i.e., within an acceptable time range). Monitoring the interval is important, for example, when the user travels between different time zones, so simply tracking treatment based on local time is insufficient.

[0105] Figure 13 represents a "score" panel 45. The score panel 45 processes and consolidates the data received from the electronic module 22 to calculate a score, in the form of points, color, progress on a scale, etc., which reflects good adherence to treatment. This good adherence consists of respecting the prescribed dosage, but also of using the correct instillation technique (indicated by the correct orientation of the bottle when dispensing the ophthalmic product). It is primarily a fun way to encourage the user to follow their treatment as closely as possible, by consciously or unconsciously prompting them to improve their score. The score panel may include a reminder of the calculation rule used 46. The score panel includes a display area for the weekly score 47 (current week or rolling week).

[0106] The score for each week can be stored, so as to present the evolution of weekly scores in a score evolution zone 48. Finally, a cumulative score zone 49 presents a score based on the whole treatment, for example in the form of a progress bar or a slider indicating an average compliance score.

[0107] The module thus developed in the invention enables the detection of actuations of a mechanically pumped bottle, in particular one with axial actuation (along a principal axis of the bottle). The detection of actuations, coupled with temporal information (actuation time, intervals between actuations) and, where applicable, with information concerning the orientation of the bottle during The pump's activation allows for monitoring adherence to and the quality of instillation of a treatment, according to the prescribed dosage. The fact that the module is independent of the bottle offers several advantages. For example, the module can be transferred to multiple bottles during a long-term treatment. The module can be prescribed only to certain patients: patients prone to forgetting to follow their treatment, patients who may doubt after a few moments whether or not they have instilled the ophthalmic product, or patients starting treatment. Furthermore, it is possible to equip a pre-existing bottle, i.e., one already on the market, only when desired or necessary. Thus, without creating a new range of ophthalmic products, it is possible to offer the same bottle without a module or with an independent module, depending on the product contained in the bottle, the market (geographic area), etc.

[0108] The module can also teach the user the correct instillation technique, necessary for effective treatment. When the electronic module is linked, for example paired, with computer equipment running appropriate software, such as a smartphone running a dedicated application, the data obtained by the electronic module and transferred to the electronic equipment can be processed to characterize treatment adherence and, where appropriate, encourage the user to improve it.

Claims

Demands

1. Electronic module (22) for detecting and transmitting and / or recording data relating to the actuation of a mechanical pump of a bottle (1) of a liquid ophthalmic product comprising a main body (2) having a reservoir (4), a dispensing head (3) and a mechanical pump, the dispensing head (3) being mounted on the main body, the dispensing head (3) having a movable part (6) whose movement relative to the main body (2) actuates the mechanical pump to draw the liquid ophthalmic product present in the reservoir (4), characterized in that said electronic module (22) is independent of said bottle (1) so that it can be attached to and fixed thereto, said electronic module (22) having an actuator (28) configured to be driven in motion by the movement of the movable part (6), said module having a sensor configured to be actuated by the movement of the actuator (28),and in that the electronic module (22) comprises a housing (24) forming an internal volume for receiving at least one electronic card (23), said housing comprising a base and a cover, said base comprising an opening allowing the passage of the actuator (28).

2. Electronic module (22) according to claim 1, adapted to a bottle in which the moving part (6) is movable in axial translation relative to the main body (2), in which the sensor is a contactor (35), the actuator (28) is guided in translation along said axial direction, and the actuator (28) has a first bearing surface (30) on the moving part (6) and a second bearing surface (31) on the contactor (35).

3. Electronic module (22) according to claim 2, wherein the actuator (28) is in the form of a rod extending along the axial direction, the rod having a first end forming the first bearing surface (30), and a second end, opposite to the first end, forming the second bearing surface (31).

4. Electronic module (22) according to any one of the preceding claims, comprising a spring (29) tending to return the actuator (28) to a rest position.

5. Electronic module (22) according to claims 2 and 4 in which the contactor (35) is open when the actuator (28) is in the rest position.

6. Electronic module (22) according to any one of the preceding claims, comprising at least one accelerometer configured to provide orientation information for the electronic module (22).

7. Electronic module (22) according to any one of the preceding claims, comprising an electronic memory configured to store data relating to the actuations of the actuator (28), including the number, date and time of the actuations.

8. Electronic module (22) according to any one of the preceding claims, comprising a communication port, wired or wireless, configured for data transfer to external computing equipment.

9. Electronic module (22) according to claim 9, wherein the module is configured to transfer data to external computing equipment according to a Bluetooth™ protocol.

10. 10. An assembly comprising a bottle (1) of a liquid ophthalmic product and an electronic module (22) according to any one of the preceding claims, the bottle (1) comprising a main body (2) having a reservoir (4), a dispensing head (3), and a mechanical pump, the dispensing head (3) being mounted on the main body (2), the dispensing head (3) having a movable part (6) whose movement actuates the mechanical pump to withdraw the liquid ophthalmic product present in the reservoir (4), the electronic module (22) being attached and fixed either to the main body or to the dispensing head (3) such that the movement of the movable part (6) relative to the main body (2) to withdraw the liquid ophthalmic product present in the reservoir (4) causes the actuator (28) of the electronic module (22) to move.

11. Assembly according to claim 10, wherein the bottle (1) comprises a delivery-assist device and in which the moving part (6) is movable in axial translation relative to the main body (2), the main body (2) comprising a first part of the delivery assistance device (13) which cooperates with the reservoir (4) of said main body (2), the first part of the delivery assistance device (13) comprising a first lateral fin (11), the distribution head (3) comprising a second part of the delivery assistance device (14) which cooperates with the moving part (6), the second part of the delivery assistance device (14) comprising a second lateral fin (12), the first lateral fin (11) and the second lateral fin (12) being substantially opposite each other to allow axial movement of the moving part (6) when a force is exerted between the two lateral fins (11,12) tending to bring them axially closer together.

12. Assembly according to claim 11, wherein, during axial movement of the moving part (6), the actuator (28) bears against, and is actuated by, the second part of the delivery assistance device (14).

13. Assembly according to claim 12, wherein the first lateral fin (11) has a hole through which the actuator (28) of the electronic module (22) passes, said actuator (28) bearing during the axial movement of the moving part (6) on a radial protrusion (17) of the second part of the delivery assistance device (14).

14. A device for monitoring adherence to a therapeutic treatment, comprising an electronic module (22) according to claim 8 or claim 9, and external computer equipment configured to communicate with said electronic module (22), the electronic module (22) being configured to transmit data relating to the actuation of the actuator (28) to the computer equipment, the computer equipment running software enabling temporal tracking of the actuations of the actuator (28) of the electronic module (22), which correspond to a delivery of the ophthalmic product.

15. A device for monitoring adherence to a therapeutic treatment according to claim 14, wherein the computer equipment running the software is configured for recording of a dosage, and for providing the user with a comparison between the recorded dosage and the data relating to the actuation of the actuator (28) of the electronic module (22) transmitted to the computer equipment.

16. A device for monitoring adherence to a therapeutic treatment according to claim 14 or claim 15, the electronic module (22) further conforming to claim 7, the module being configured to transmit data relating to its orientation, wherein the computer equipment executing the software is configured to allow the user to view information as to the correct or incorrect orientation of the electronic module (22), and therefore in correspondence with a bottle (1) equipped with said electronic module (22), during the actuations of the actuator (28).

17. A device for monitoring adherence to a therapeutic treatment according to claim 16, wherein the computer equipment running the software is configured to emit in real time a signal indicating that the module has a correct orientation for the distribution of liquid ophthalmic product by a bottle (1) equipped with said electronic module (22).

18. A device for monitoring adherence to a therapeutic treatment according to any one of claims 14 to 17, wherein the computer equipment running the software is configured to calculate, on the basis of the data transmitted by the module, an adherence score and indicates it to the user.

19. Device for monitoring adherence to a therapeutic treatment according to any one of claims 14 to 18 wherein the computing equipment is a smartphone or tablet, and the software is an application.

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