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US-12616608-B2 - Device and method for monitoring compliance with a therapeutic ophthalmic treatment

US12616608B2US 12616608 B2US12616608 B2US 12616608B2US-12616608-B2

Abstract

Disclosed is a device for monitoring compliance with a therapeutic ophthalmic treatment using an electronic module intended to detect and transmit to a computer system data related to the actuation of a mechanical pump of a vial of an ophthalmic product. The electronic module is independent of the vial, to which it may be attached and secured. The electronic module further includes an orientation sensor. This electronic module makes it possible to characterize compliance with a treatment by the user of the vial. Also disclosed is a corresponding method for monitoring compliance with a therapeutic ophthalmic treatment, with such a module installed on a vial, and an item of computer equipment that can communicate with the electronic module.

Inventors

  • Fabrice Mercier

Assignees

  • LABORATOIRES THEA

Dates

Publication Date
20260505
Application Date
20210302
Priority Date
20200303

Claims (8)

  1. 1 . A method for monitoring compliance with an ophthalmic therapeutic treatment, the method comprising: providing an ophthalmic product vial and a device configured to monitor compliance with an ophthalmic therapeutic treatment, the device comprising an external computer equipment, and an electronic module configured to detect data relating to an actuation of a mechanical pump of a vial of a liquid ophthalmic product including 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 portion a movement of which relative to the main body actuates the mechanical pump to sample the liquid ophthalmic product present in the reservoir, the electronic module being independent of said vial so that the electronic module is configured to be attached and fastened therein, the electronic module including an actuator configured to be set in motion by the movement of the movable portion, a sensor configured to be actuated by the movement of the actuator, an orientation sensor configured to provide information relating to its orientation, and a wired or wireless communication port configured to transfer data relating to the actuation of the mechanical pump of the vial and the data relating to its orientation towards an external computer equipment, fastening the electronic module on the ophthalmic product vial; determining, over time, correct product instillations and incorrect product instillations, according to compliance parameters including a detection, within a specific time frame, of one or more actuations of the vial and a detection of a correct orientation of the vial; providing a user with the results of the determining the correct product instillations and the incorrect product instillations; calculating a compliance score as a function of the compliance parameters, the compliance score being a mark in a form of one of points, a color, and a level on a scale, the compliance score reflecting a proper compliance with the ophthalmic therapeutic treatment, the proper compliance including complying with the prescribed dosage and adopting a proper orientation of the vial when dispensing the ophthalmic product; and indicating the calculated compliance score to the user, wherein said external computer equipment is configured to communicate with said electronic module, the external computer equipment executing software enabling temporal monitoring of the actuations of the actuator of the electronic module, which correspond to a delivery of the ophthalmic product, the external computer equipment being configured to provide the user with information on the correct or incorrect orientation of the electronic module, and therefore accordingly of the vial equipped with said electronic module, when the actuator is actuated, the external computer equipment executing the software being configured to calculate, based on the data transmitted by the electronic module, the compliance score and indicate the compliance score to the user.
  2. 2 . The method for monitoring compliance with the ophthalmic therapeutic treatment according to claim 1 , further comprising: informing the user on a temporal progression of said compliance score.
  3. 3 . The method for monitoring compliance with the ophthalmic therapeutic treatment according to claim 1 , wherein the information on the correct or incorrect orientation of the electronic module includes visual information.
  4. 4 . The method for monitoring compliance with the ophthalmic therapeutic treatment according to claim 1 , wherein the information on the correct or incorrect orientation of the electronic module includes audible information.
  5. 5 . The method for monitoring compliance with the ophthalmic therapeutic treatment according to claim 1 , further comprising emitting in real-time a signal indicating that the electronic module has the correct orientation to dispense a liquid ophthalmic product by the vial equipped with said electronic module.
  6. 6 . The method for monitoring compliance with the ophthalmic therapeutic treatment according to claim 1 , further comprising transferring the data towards the external computer equipment according to a Bluetooth™ protocol.
  7. 7 . The method for monitoring compliance with the ophthalmic therapeutic treatment according to claim 1 , further comprising storing, by an electronic memory of the electronic module, data relating to the actuations of the actuator.
  8. 8 . The method for monitoring compliance with the ophthalmic therapeutic treatment according to claim 1 , further comprising recording a dosage and providing the user with a comparison between the recorded dosage and the data relating to the actuation of the actuator of the electronic module transmitted to the external computer equipment.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S) This application is the U.S. national phase of International Application No. PCT/EP2021/055167 filed Mar. 2, 2021, which designated the U.S. and claims priority to FR 2002157 filed Mar. 3, 2020, the entire contents of each of which are hereby incorporated by reference. BACKGROUND OF THE INVENTION Field of the Invention The present invention relates to the field of dispensing ophthalmic products, comprising pharmaceutical solutions and other liquid ophthalmic preparations, in particular eyewashes. In particular, the invention relates to the field of devices used to deliver ophthalmic product drops from a reservoir using a mechanical pump. Thus, the present invention relates to liquid dispensing vials, and more particularly to dispensing vials equipped with a pump system to initiate the dispense of this liquid. The principle of such sprayers has been described in document FR-2 739 294, in an application to nasal spraying. Description of the Related Art The document WO 2010/139883 filed by the Applicant discloses the use of such a sprayer for an ophthalmic application, with ergonomics suitable for this use. Indeed, in this vial type, a pump mechanism which is actuated by pressing a movable portion of the device is used in a known manner. In order to design a vial with optimal ergonomics, which facilitates handling and which allows applying on the movable portion the force necessary for the activation of the pump, it is known to equip it with a cap to help in manoeuvring the movable portion and therefore the pump. Such a cap includes a cylindrical body which at least partially covers the reservoir of the vial, and which has at its top a planar upper wall pierced at its centre to enable the passage of the diffuser endpiece of the vial. When the cap is in place on the vial, the upper wall bears against the movable portion of the pump. Thus, the extent of the area over which one presses to actuate the pump is increased and its long-term operation is facilitated. Different variants of caps can be used with the vial to facilitate actuation of the pump, for example in the form as claimed in the document WO 2010/139883 filed by the Applicant, which describes a cap in two portions adapted to slide towards each other parallel to the axis of the pump and each having a lateral gripping fin, which further facilitates the actuation of the portions of the pusher. In this context, the Applicant has also filed the document WO 2014/170736, which proposes a liquid dispensing vial including a cap which enables a simple and effective marking aimed at warning the user of the first use of the vial, i.e. enabling the user to notice whether the vial has already been opened or not, in order to facilitate the conservation of the vials according to the recommendations for use. Moreover, the effectiveness of many ophthalmic treatments depends on several parameters, in particular on compliance with the treatment dosage, and, in particular for vials with a mechanical pump, on the correct orientation of the vial during instillation of the liquid ophthalmic product. In order to control the position of an ophthalmic product vial, in order to guarantee a correct instillation position, mechanical guides which impose a correct position on the vial by application around the eye are known, for example through the documents JP2003310710 and JP2008295880. Nevertheless, these systems are barely pleasant. The document EP2912460 discloses a vial including a position sensor which is used to activate a drop optical sensor. When the position of the vial is correct, the device automatically triggers the means for controlling the product delivery. This system is complex, it does not involve a vial with a mechanical pump, and does not enable the user to select the instillation time. Besides the aforementioned problems, the matter of monitoring compliance with the dosage remains unresolved in the prior art. Moreover, this strict control of compliance with the dosage turns out to be not necessary for all treatments or for all patients, but could on the contrary be useful over a quite long period during which several vials of an ophthalmic product are successively used. Thus, the present invention aims to propose a device allowing solving all or part of the aforementioned problems. SUMMARY OF THE INVENTION To this end, a device for monitoring compliance with an ophthalmic therapeutic treatment is proposed in the invention. This device includes an electronic module intended to detect data relating to the actuation of a mechanical pump of a vial of a liquid ophthalmic product including 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 portion a movement of which relative to the main body actuates the mechanical pump to sample the liquid ophthalmic product present in the reservoir. In the proposed device for