WO2019106583A1

WO2019106583A1 - Vial case

Info

Publication number: WO2019106583A1
Application number: PCT/IB2018/059434
Authority: WO
Inventors: Anna Lucia VALERI; Maria D'ORAZIO; Alessandro Ferroni; Glauco Bigini; Gabriele FAORO; Margherita Colleoni
Original assignee: Dompe' Farmaceutici S.P.A.
Priority date: 2017-12-01
Filing date: 2018-11-29
Publication date: 2019-06-06

Abstract

A case (100) for a vial (40) containing a drug (F) to be administered is described, said case comprising a container body (10) provided with a recess (11) for housing the vial (40) and a cap (20) which can be coupled to the container body (10) and is movable between a first open position of the case (100) and a second closed position of the case (100). The case (100) also comprises an electronic control unit (50); at least one first sensor (30) provided at the recess (11) of the container body (10) and configured to detect the insertion of the vial (40) inside the housing recess (11) and to transmit a respective first signal (s3o) to the electronic control unit (50); at least one second sensor (31) arranged between the container body (10) and the cap (20) and configured to detect the opening/closure of the cap (20) and to transmit a respective second signal (s3i) to the electronic control unit (50); and signaling means (32) for the user which can be activated by the electronic control unit (50) upon receiving of the first signal (s3o) and the second signal (s3i) by the electronic control unit (50) and based on dosage data (dp) of the drug (F) which can be stored in the electronic control unit (50). A method for the controlled administration of a drug (F) carried out using the aforementioned vial case (100) is also described.

Description

Vial case

DESCRIPTION

Technical field of the invention

The present invention relates, in general, to a case for a vial containing a drug, for example a drug for ophthalmic use. More particularly, the present invention relates to a vial case configured to allow the controlled administration of the drug contained in the vial, in order to obtain benefits from a drug therapy.

Background of the invention

The dosage forms a part of the medical prescription which indicates the doses and the time intervals for taking a drug and which is commonly also contained in the information leaflet supplied with the drug, also known as "package insert".

Many illnesses result in the need for patients to take a drug several times a day for short or long periods of time, based on the prescribed treatment. Moreover, during the treatment, the dosage may be subject to variations. For example, and with particular reference to eye diseases, and more particularly neurotrophic keratitis, a degenerative disease of the cornea, a patient may be required to self-administer eye drops, typically daily every two hours for the first two days and thereafter twice a day for the next fortnight.

Moreover, it is possible that a patient may suffer from a disease which requires the administration, during the day, of more than one drug, each of which has its own dosage.

Nowadays, moreover, the risk of a patient forgetting to administer one or more doses of a drug may increase owing to the hectic pace of life, with people continuously on the move and under pressure from many commitments. From the above it is clear that the user of a drug may experience difficulty in keeping to the prescribed dosage in a correct and totally autonomous manner. The user could forget to administer one or more doses of a drug, thus compromising the effectiveness of the therapy. In fact the failure to keep to the correct dosage, for example forgetting to take a dose and/or not respecting the time interval between one dose and the next, often has negative consequences. A therapy which is not properly carried out could in fact result in a reoccurrence or worsening of the illness. The aforementioned problem increases in the case where several drugs must be taken during the day.

The main object of the present invention is therefore to provide a case for a vial and a method for the controlled administration of a drug contained in the vial which are able to allow a user, during drug therapy, to administer the drug in accordance with the dosage indicated on the information leaflet for the drug contained inside the vial and/or as agreed with the doctor responsible for the treatment.

Another object of the present invention is to provide a case for a vial and a method for the controlled administration of a drug contained in the vial which are able to help the doctor to assess the actual effectiveness of the therapy in progress and make any suitable changes to it.

Yet another object of the present invention is to provide a case for a vial and a method for the controlled administration of a drug contained in the vial which are able to help the doctor check that the drug is being taken as prescribed. The bad practice of not following the prescription prepared by the doctor is in fact very common among patients.

Yet another object of the present invention is to provide a case for a vial which may be used in an easy and immediate manner by a user. In fact, it must be taken into account that the users of a drug may be of varying ages and often elderly people are unable to use particularly complex technological aids.

Last but not least, an object of the present invention is to provide a case for a vial which may be produced at a low cost.

These and other objects, which will appear more clearly from the present description below, are achieved by a case for a vial and by a method for the controlled administration of a drug contained in the vial according to the independent claims 1 and 1 1. Preferred features of the case and the method are described in the dependent claims 2 to 10 and 12 to 18, respectively.

According to a first aspect thereof, the invention therefore relates to a case for a vial containing a drug to be administered, comprising a container body provided with a recess for housing the vial and a cap which can be coupled to the container body and is movable between a first open position of the case and a second closed position of the case.

The case is characterized in that it comprises an electronic control unit; at least one first sensor provided at the recess of the container body and configured to detect the insertion of the vial inside the housing recess and to transmit a respective first signal to the electronic control unit; at least one second sensor arranged between the container body and the cap and configured to detect the opening/closure of the cap and to transmit a respective second signal to the electronic control unit; and signaling means for the user, which can be activated by the electronic control unit upon receiving of the first signal and the second signal by the electronic control unit and based on dosage data of the drug which can be stored in the electronic control unit. Owing to this combination of features, the case according to the present invention is able to signal to the user the moments during the day when administration of the drug F contained inside the vial is required, checking at the same time that administration has taken place. This ensures advantageously compliance with the dosage and the effectives of the prescribed therapy.

According to a second aspect thereof, the invention relates to a method for the controlled administration of a drug carried out using a case for a vial as described above, the method comprising the steps of:

- positioning a vial containing a drug in a recess of a container body of the case;

- detecting by means of at least one first sensor of the case the insertion of the vial in the case; and

- signaling to a user, by means of signaling means of the case, the need to proceed with administration of at least one dose of the drug according to drug dosage data which can be stored in the case.

In the following of the present description and in the attached claims, the expression "external data processing device" is understood as referring to any type of electronic device, which may or may not be portable, such as a smartphone, a palmtop computer or PDA (Personal Digital Assistant), a tablet, a portable computer, a computer and similar devices.

Brief description of the drawings

Further characteristics and advantages of the present invention will emerge more clearly from the following detailed description of preferred embodiments of a case for a vial and a method for use thereof, provided hereinbelow by way of a non-limiting example with reference to the accompanying drawings. In the drawings:

- Figure 1 a is a partial, schematic, cross-sectional view of a case for a vial according to a first embodiment of the present invention, in an open configuration and with a vial not yet inserted inside it; - Figure 1 b is a view, similar to that of Figure 1 a, with the case for a vial in the open configuration and the vial inserted inside it;

- Figure 1c is a view, similar to that of Figure 1 a, with the case for a vial in the closed configuration and the vial inserted inside it;

- Figure 2 is a perspective view of the case for a vial according to Figures 1 a to 1c, which shows an internal detail of the cap;

- Figure 3 is a functional block diagram, which shows the various electronic components of the case for a vial and the mode of interaction between them;

- Figure 4 is a schematic cross-sectional view of a case for a vial according to an alternative embodiment of the present invention, in an open configuration and with a vial inserted inside it; and

- Figure 5 is a flow diagram, which schematically illustrates the various steps of a method for using the case for a vial according to Figures 1 to 3, for correct administration of a drug contained inside the vial.

Description of preferred embodiments of the invention

With reference to Figures 1 a-1c to 3, these show a case for a vial according to a preferred embodiment of the present invention.

The vial case, which is denoted generally by the reference number 100, comprises a container body 10 closed by a cap 20.

The container body 10, which preferably has a substantially cylindrical shape, has a bottom 12 and a side surface 14 extending upwards from the bottom 12. The container body 10 has, defined inside it, a recess 1 1 provided with an aperture 17 for housing a vial 40 containing a drug F which is to be administered. The recess 1 1 has preferably dimensions corresponding to those of the vial 40 which it is intended to house and comprises a bottom surface 13 and a side wall 15. As shown in detail in Figure 1 a, the vial 40 has a main body 42 containing the drug F, provided with a base 41 , and a neck 44 protruding from the main body 42.

Preferably, the vial 40 contains a drug F in liquid form, more preferably a drug for ophthalmic use. Obviously, the vial 40 may contain also drugs which are not in liquid form, for example tablets.

The container body 10 may assume a wide variety of forms, for example it may have a prismatic form. Moreover, in some embodiments (not shown in the figures), the side surface 14 may be shaped in order to facilitate gripping of the case 100 by the user.

The cap 20 can be coupled to the container body 10 and is movable between a first position or open configuration of the case 100 - shown in Figures 1 a, 1 b and 2 - in which the cap 20 is partially or totally removed from the container body 10 so as to allow access to the recess 1 1 , and therefore to the vial 40 which may be housed inside it, and a second position or closed configuration of the case 100 - shown in Figure 1c - in which the recess 1 1 is bounded at the top by the cap 20, and the vial 40, once inserted inside the recess 1 1 , is stably confined inside the case 100.

In the embodiment shown, the cap 20 is removably coupled to the container body 10 by means of a hinge 22. However, other ways of joining together the cap 20 and the container body 10 are possible. For example, the cap 20 may be screwed or press- fitted onto the container body 10.

Preferably, the container body 10 and the cap 20 are made of plastic material, such as polyethylene terephthalate (PET). The use of PET allows in particular a vial case 100 which is light, strong, low-cost and recyclable to be obtained.

It is known that drugs, in particular those for ophthalmic use, independently of the season and the climatic conditions, must be stored at certain temperatures. In particular, it is necessary to avoid keeping the drugs in environments which are damp, hot or exposed to sunshine in order to prevent them from being heated to high temperatures. Moreover, some drugs may be very costly.

It therefore becomes important for the user to have an instrument which ensures optimum preservation of the drug. This is necessary in order to avoid, firstly, wastage of the drug itself and, secondly, the need to replace the drug which has deteriorated and therefore is no longer effective, something which would result in further expenditure on the part of the user.

To achieve this, preferably a gap 16 is defined between the side wall 14 of the container body 10 and the side wall 15 of the housing recess 1 1 . Moreover, as shown in detail in Figure 2, the cap 20 has, along an inner wall 24 thereof, a plurality of longitudinal fins 21.

When the vial 40 is housed inside the recess 1 1 , with the case 100 in the closed configuration, the main body 42 of the vial 40 is housed, preferably without clearance, inside the recess 1 1 , with the neck 44 of the vial 40 housed inside the cap 20.

In the case where the cap 20 has the fins 21 , the neck 44 of the vial 40 is embraced by said fins 21.

The gap 16 and the fins 21 create, in the aforementioned closed condition of the case 100, an air chamber which ensures that a correct temperature is maintained inside the case 100, with consequent optimum preservation of the drug F contained in the vial 40. This is particularly advantageous in the case where the user must take the drug F at certain moments during the day when he/she is in places far from his/her own home where correct storage of the drug, for example far heat sources and without direct exposure to light, is simpler. With particular reference to a vial for eye drops, said vial may be provided with a safety closure, for example a Luer lock closure.

In this case, when the cap 20 is closed onto the container body 10, the fins 21 formed inside it exert on the vial 40 a pressure sufficient to force the safety closure, with consequent opening of the vial 40.

Owing to the aforementioned configuration of the cap 20, it is not necessary for the user to open the vial 40 before inserting it into the case 100, since opening of the vial 40 occurs automatically when the cap 20 is closed.

This is particularly advantageous in the case of patients who suffer from illnesses which result in insensitivity of the tissue where topical treatment is performed, for example patients suffering from neurotrophic keratitis. In fact, these patients are unable to sense whether the topical administration of the eye drops has actually occurred and therefore are unable to determine whether the vial 40 has been opened or not.

Furthermore, when the closing cap 20 is closed onto the container body 10, the fins 21 push the vial 40 downwards, causing the base 41 of the main body 42 to press against the bottom 13 of the recess 1 1 . This allows advantageously correct positioning of the vial 40 inside the case 100.

The case 100 further comprises a first sensor 30, a second sensor 31 and an electronic control unit 50 in electrical communication with the first sensor 30 and the second sensor 31 .

The first sensor 30 is positioned at the bottom 13 of the recess 1 1 of the container body 10 and is designed to detect correct insertion of the vial 40 inside the recess 1 1 and to transmit a first signal s₃o (Figure 3) to the electronic control unit 50.

The second sensor 31 is arranged between the container body 10 and the cap 20 and is designed to detect closing of the cap 20 and to transmit a second signal s_3i (Figure 3) to the electronic control unit 50.

Preferably, the second sensor 31 is positioned on an edge portion of the cap 20 which is directed, during use, towards the container body 10. Alternatively, the second sensor 31 is positioned next to the aperture 17 of the recess 1 1 of the container body 10.

Preferably, the first sensor 30 and the second sensor 31 are pressure switches. Obviously it is possible to envisage using sensors made with different technologies, depending on the material from which the vial 40 is made. By way of example it is possible to envisage electrical contact sensors, for vials made of metallic material, or optical sensors, micro-switches, deformation sensors (strain gauges) and/or capacitive type sensors. Alternatively it is possible to use a greater number of sensors than those which are shown, while maintaining in any case their position and function, for variants where a greater detection reliability is required.

The electronic control unit 50 is housed inside the case 100 and, as shown in detail in Figure 3, comprises a processor 52, a timer 54 and a memory unit 56.

The memory unit 56 stores data dp relating to the dosage of the drug F contained inside the vial 40, in particular number N of daily administrations of the drug F and time interval DΪ_N-N+I between two successive administrations and duration D of the therapy.

The memory unit 56 may also store data relating to the mode of use of the case 100, such as: events involving opening and/or closing of the cap 20; events involving insertion and/or removal of the vial 40 into/from the recess 1 1 of the container body 10; intervals between successive opening of the cap 20; intervals between successive closing of the cap 20; and interval between insertion and removal of the vial 40 into/from the case 100. In addition to the events relating to direct use of the containing device, and as will be described in greater detail below in the continuation of the present description, the electronic control unit 50 may also be programmed to detect more complex events consisting of combinations of the aforementioned events combined with time scale detection. These compound events, for example, may consist of excessively long opening intervals, cap opening and closing frequencies beyond certain limit values, detection of anomalous opening and closing sequences and other kind of similar configuration.

The case 100 comprises moreover signaling means 32 arranged preferably on the side surface 14 of the container body 10 and designed to alert the user that it is time to take a dose of the drug contained inside the vial 40 and to indicate that this dose has been administered, thus ensuring that the prescribed dosage is complied with.

In particular, the signaling means 32 are controlled by the electronic control unit 50 depending on the signals received by the electronic control unit 50 from the first sensor 30 and from the second sensor 31 , as will be described in greater detail below with reference to Figures 3 to 5.

Preferably, as shown in greater detail in Figure 3, the signaling means consist of a luminous signaling device 32, typically an LED (light emitting diode) such as an RGB LED. However, it is possible to envisage signaling means of another type, for example acoustic, vibration and similar signaling means.

In the case where the signaling means 32 are of the acoustic or vibration type, the case 100 may comprise a pushbutton switch (not shown in the figures) which can be operated by the user in order to switch off the signaling means 32. Alternatively, the signaling means 32 may be switched off automatically when the cap 20 is opened. The case 100 may also comprise an additional sensor 34 located in the container body 10 at the recess 1 1 or, alternatively, inside the closing cap 20. This sensor may measure, depending on the vial design and monitoring characteristics, environmental parameters such as the temperature inside the cavity 1 1 , the relative humidity and the atmospheric pressure.

More particularly and as shown in detail in Figure 3, the additional sensor 34 is a temperature sensor able, during use, to measure the temperature of the drug F contained inside the vial 40 and/or the temperature of the recess 1 1 housing the vial 40 and to generate a corresponding temperature signal ST which is transmitted to the electronic control unit 50.

The electronic control unit 50 performs, in turn, a comparison between the temperature signal ST received from the temperature sensor 34 and a temperature value T_preserv for correct preservation of the drug F pre-set and stored in the memory 56 and, if the temperature signal s_T received is greater than the temperature value T_preserv stored, it activates corresponding signaling means 36 provided on the side surface 14 of the container body 10 of the case 100 and entirely similar, both structurally and functionally, to the signaling means 32 described above. In an alternative embodiment, the signaling means 32 and the signaling means 36 may coincide.

Preferably, the case 100 further comprises a pushbutton 64 positioned preferably on the container body 10 of the case 1 00 and, by operating this pushbutton, the user may check at any moment the state, for example the preservation temperature of the drug F contained inside the vial 40.

In particular, following pressing of the pushbutton 64 by the user, the additional sensor 34 is activated and, if the drug F is not being preserved properly, the electronic control unit 50 activates the signaling means 36. Furthermore, and as will be described in detail below, the pushbutton 64 may be pressed by the user in order to signal to the electronic control unit 50 the first daily administration of the drug F. Preferably, the case 100 may be provided with movement detection means 33, which are housed in the container body, in the cap or in the electric control unit 50 and are designed to detect, by means of inertial (accelerometric or gyroscopic) or magneto metric measurements, the orientation and the movements of the case 100 in space. In the embodiment shown, the movement detection means 33 consist of a gyroscope, in electrical communication with the electronic control unit 50 and designed to signal to the latter the movement of the case 100, for example whether the case 100 has been turned upside down by the user in order to administer the drug F.

The case 100 further comprises at least one battery unit 60 for powering the electronics. The battery unit 60 is positioned underneath the recess 1 1 of the container body 10 and is preferably formed by at least one battery rechargeable via a recharging circuit, for example a USB port 62, present in the case 100. The USB port 62 may also be used to connect the case 100 to an external data processing device 70 (shown in Figure 3). Alternatively, a dedicated USB port may be provided.

As shown in detail in Figure 3, the case 100 may be configured to interact with an external data processing device 70.

In the following of the present description, reference will be made to a smartphone 70 by way of external data processing device, but it is understood that any other external data processing device suitable for the purpose may also be used.

For this purpose, the electronic control unit 50 is provided with a wireless communication module 58 in communication with a corresponding wireless communication module 72 provided in the smartphone 70, in order to allow data exchange between the case 100 and the smartphone 70.

The wireless communication modules 58 and 72 are wireless communication modules of the type: Bluetooth®, NFC (Near Field Communication), Wi-Fi, 3G, etc. Preferably, the smartphone 70 is provided with a software application 74 which allows the user to select the drug F contained in the vial 40 to be inserted in the case 100 and the data d_P about its dosage associated therewith.

As described above, the data dp contains information about the duration D of the therapy treatment, the number N of daily doses to be taken and the time interval D_N __N+I between the administration of one dose and the next one. The data d_P is then transmitted from the smartphone 70 to the electronic control unit 50 and stored in the memory unit 56.

As described above, in addition to the data d_P relating to the dosage, a correct preservation temperature value T_preserv may be associated with the selected drug F. This value T_preserv may also be transmitted from the smartphone 70 to the electronic control unit 50 and stored in the memory unit 56.

The software application 74 acquires the data relating to the drug F, for example the correct preservation temperature value T_preServ, and the data d_P about the drug dosage by means of reading, by the smartphone 70, of an identification code 45 associated with the vial 40 containing the drug F.

Preferably, and as shown in Figure 3, the identification code 45 is positioned on the main body 42 of the vial 40.

In a preferred embodiment, the identification code consists of a QR (Quick Response) code 45 by means of which the software application 74 is able to access the main parameters d_P and T_preServ and, by means of interaction with a suitable file, access data identifying the drug F, such as batch production number, place of production, packaged drug F, expiry date of the drug F, dosage P for the drug F and other relevant information. The QR code identification system may be replaced by other marking systems, such as a bar code, a numerical code and the like, providing similar information. This additional information is also acquired by the software application 74 and preferably transmitted to the electronic control unit 50 and stored in the memory unit 56.

In an alternative embodiment, the software application 74 acquires the data dp and T _preserv by means of communication, via the Internet I, with a remote server S containing a database of the pharmaceutical company which produces the drug F. With reference to Figure 4, this shows an alternative embodiment of a case for a vial according to the present invention.

The vial case, which is indicated generally by the reference number 1 100, is very similar to the vial case 100 described above and illustrated in Figures 1 a-1c to 3 and differs from it with regard to the different positioning of the battery unit inside the container body. The battery unit is in fact positioned alongside the recess housing the vial.

In a similar manner to the case 100, the case 1 100 therefore comprises a container body 1 10 which has, defined inside it, a recess 1 1 1 housing a vial 40 containing a drug F. The container body 1 10 is closed by a cap 120, which is preferably removably coupled to the container body 1 10 by means of a hinge 122.

The case 1 100 further comprises a first sensor 130, a second sensor 131 and an electronic control unit 150 in electrical communication with the first sensor 130 and the second sensor 131.

The sensors 130 and 131 and the electronic control unit 150 correspond, in structural and functional terms, to those described and illustrated above with reference to the case 100 and therefore will not be further described.

The case 1 100 further comprises signaling means 132 which are controlled by the electronic control unit 150 depending on signals which the electronic control unit 150 receives from the first sensor 130 and the second sensor 131 and, preferably, an associated deactivation pushbutton.

Finally, the case 1 100 comprises a battery unit 160, preferably of the rechargeable type, and an associated recharging circuit 162, as well as an activation button 164.

As clearly shown in Figure 4, the battery unit 160 is positioned alongside the recess 1 1 1. Owing to this particular location of the battery unit 160 inside the container body 1 10 of the case 1 100, advantageously a vial case 1 1 10 with more compact dimensions than those of the vial case 100 may be obtained.

With reference to Figures 3 and 5, a method for the controlled administration of a drug F carried out using a vial case according to the present invention will now be described.

In the following of the present description reference will be made to the vial case 100, it being understood that the same also applies to the vial case 1 100.

The method starts with step S1 , where the user, if necessary after switching on the case 100, inserts the vial 40 inside the recess 1 1 of the container body 10 of the case 100 (arrow F1 , Figure 1 a) until the base 41 of the vial 40 makes contact with the bottom 13 of the recess 1 1 .

The step S1 is followed by a step S2 for activation of the first sensor 30, following contact between the base 41 and the bottom 13, and consequent transmission of the first signal s₃o to the electronic control unit 50.

The step S2 is followed by a step S3, where, upon receiving the first signal s₃₀, the electronic control unit 50, in particular its processor 52, resets the timer 54 and stores a zero time to in the memory unit 56.

The step S3 is followed by a step S4, where the electronic control unit 50 determines an event of first administration of the drug F and stores a corresponding time h _admin of first administration in the memory unit 56.

During the first administration, the user opens the cap 20 of the case 100, performs administration of the first prescribed dose of the drug F and closes the cap 20 once administration has been performed.

A situation may in fact arise where the user inserts the vial 40 in the case 100 without performing immediately administration of the first dose of the drug F. Furthermore, in the case where the vial 40 has a Luer lock aperture, in order to open the vial 40 it is necessary to close the cap 20, so that the first closing of the cap 20, and the consequent activation of the first sensor 30, does not correspond to the administration of the first dose of the drug F, but to opening of the vial 40.

In step S4, upon reception of the first signal s₃₀, the processor 52 activates the timer 54 (step S41 ) and waits (step S42) for a cap closure event Ci to occur within a predetermined time interval At, preferably of not more than 30 seconds, stored in the memory unit 56.

The occurrence of the event Ci within the time window At (step S42, YES) indicates that the user has inserted the vial 40 in the recess 1 1 of the case 100 and has immediately closed the cap 20, therefore without performing the first administration of the drug F. In this case the processor 52 assumes a standby mode (step S43) where it waits for the event of first administration of the drug F.

Alternatively, the event of first administration of the drug F may be manually confirmed by the user, for example by means of operation of the pushbutton 64 provided on the case 100. When the event of first administration of the drug F occurs (step S43, YES), in particular following closure of the cap 20 of the case 100, the second sensor 31 transmits (step S44) the second signal S₃₁ to the processor 52 of the electronic control unit 50, which stores (step S45) the time ti _admin of first administration in the memory unit 56.

If this is not the case (step S43, NO), namely if the event of first administration of the drug F does not occur, the timer 54 calculates (step S46) a waiting time t_wait for the first administration event. If the waiting time t_wait is greater than or equal to a predetermined threshold value t_{waitthreshoid} stored in the memory unit 54, equal to 2 hours (step S46, YES), the method proceeds to step S47, where the electronic control unit 50 transmits the activation signal S₃₂ to the signaling means 32 of the case 100, so as to alert the user to perform the first administration of the drug F.

The user, at this point, opens the cap 20 of the case 100 and proceeds to administer the first dose of the drug F and the method passes to step S44, where the second sensor 31 transmits the second signal S₃₁ to the processor 52 of the electronic control unit 50, and to the step S45, where the processor 52 of the electronic control unit 50 stores the time ti _admin of first administration in the memory unit 56. Otherwise (step S46, NO) the method proceeds directly to step S44 and from step S44 to step S45. Still with reference to the step S4 for determining the event Ci of first administration of the drug F, the absence of the event Ci within the time window At (step S42, NO) indicates that the user has inserted the vial 40 inside the recess 1 1 of the case 100, then proceeding to administer the first dose of the drug F. In this case, the method proceeds directly to step S44 and the time t₀ for resetting the timer 54 coincides with the time ti _admin for first administration of the drug F.

The step S4 is followed by a step S5, during which the case 100 alerts the user to proceed with the second administration of the drug F in accordance with the dosage data dp stored in the memory unit 56 of the electronic control unit 50.

In particular, the step S5 comprises a step S51 during which the processor 52 operates the timer 54 so as to calculate the time interval DΪ_N-N+I between two successive administrations of the drug F and, once this time interval At_{N N+i} has lapsed (step S51 , YES), transmits (step S52) the activation signal s₃₂ to the signaling means 32 of the case 100, in order to alert the user to proceed with the administration of the next dose of the drug F.

The user, at this point, proceeds to administer the next dose of the drug F and the method passes to step S52, where the second sensor 31 detects the closing of the cap 20 and transmits the second signal s_3i to the processor 52 of the electronic control unit 50.

The step S5 is repeated a number n1 of times equal to the number N of daily administrations of the drug F prescribed by the dosage and stored in the memory unit 56 of the electronic control unit 50.

Once the prescribed number N of daily doses has been reached (step S6, YES), the method passes to step S7, where the steps S4 to S6 are repeated a number n2 of times equal to the duration D of the prescribed therapy, which is stored in the memory unit 56 of the electronic control unit 50.

In the case where the case 100 is provided with the temperature sensor 34, the method according to the invention envisages preferably a step of checking the temperature of the drug F contained in the vial 40 housed in the recess 1 1 of the container 10.

As described above, this temperature checking step comprises the steps of:

- detecting the temperature of the drug F by means of the temperature sensor 34; - transmitting a corresponding temperature signal S_T to the electronic control unit 50;

- comparing, by means of the electronic control unit 50, the temperature signal S_T received from the temperature sensor 34 and a temperature value T_preserv for correct preservation of the drug F stored in the memory unit 56; and

- if the temperature signal s_T received is higher than the temperature value T_preserv stored, activating the signaling means 36, so as to signal to the user that the drug F is not stored correctly and could therefore deteriorate and become no longer effective.

The data d_P relating to the dosage of the drug F contained in the vial 40 to be inserted in the case 100, 1 100, as well as, for example, the correct preservation temperature T_preServ of the drug F and other data relating to the drug F, may be stored by the manufacturer in the memory unit 54 of the electronic control unit 50 or, as described above, may be transmitted to the case 100, 1 100, via cable or wirelessly, by means of an external data processing device, for example a smartphone 70. This allows, advantageously, the same case 100 to be used for administration of a different drug, provided that the vial 40 which contains it has dimensions such that it may be housed in the recess 1 1 of the case 100, 1 100. In this case, the administration method described above comprises, before the step S1 of inserting the vial 40 inside the case 100; 1 10, a preliminary step of storing, in the memory unit 56 of the electronic control unit 50, the data dp (N, DΪN_N₊I , D) , the temperature T_preServ and/or other data relating to the drug F.

In this case, and with reference, for example, to a smartphone 70, this preliminary step comprises the steps of:

- acquisition, by the application 74 present in the smartphone 70, of the data dp (N, DΪN_N₊I , D), of the temperature T_preserv and/or of other data relating to the drug F to be administered;

- transmission, by means of the wireless communication module 72 of the smartphone 70, of the data acquired to the corresponding wireless communication module 58 of the case 100, 1 100; and

- storage of the data received in the memory unit 56 of the case 100, 1 100.

The step of acquisition of the data by the application 74 of the smartphone 70 may be performed by means of reading, by the smartphone 70, of the identification code 45 present on the vial 40, for example the QR code, or, alternatively, by means of communication, via the Internet I, with the remote server S containing a database of the pharmaceutical company which produces the drug F.

In an alternative embodiment of the method, the electronic control unit 50 is configured to store the progression of the administration of the drug F by the user and to transmit, via cable or wirelessly, the data acquired to the external data processing device 70. More particularly, the user may create, on the application 74 of the smartphone 70, a personal profile containing the data about the mode of use of the case 100 saved in the memory unit 56 thereof and sent wirelessly to the smartphone 70; this personal profile of the patient may be stored on the server S and consulted by a doctor with the necessary authorization for consultation using a further external data processing device. In this way the doctor who prescribed the drug therapy may check that the drug F is being taken as prescribed, assess the actual effectiveness of the therapy and makes any suitable changes thereto.

The above description clearly illustrates the features of the vial case and the method for the controlled administration of a drug according to the present invention, as well as the associated advantages.

Further variants of the embodiments described above are possible, without departing from the teaching of the invention. For example, the smartphone 70 may act as an additional signaling means. In other words, at the moment of administration of the drug, the electronic control unit may transmit an alert signal to the smartphone which, via the application 74, may be made to vibrate or, alternatively or in addition, may display an administration alert message. Moreover all the details may be replaced by technically equivalent elements. Basically the materials used, as well as the dimensions, may be of any nature depending on the technical requirements.

Claims

1. A case (100; 1100) for a vial (40) containing a drug (F) to be administered, the case comprising a container body (10; 110) provided with a recess (11 ; 11 1 ) for housing the vial (40) and a cap (20; 120) which can be coupled to the container body (10; 1 10) and is movable between a first open position of the case (100; 1100) and a second closed position of the case (100; 1 100),

characterized in that it comprises:

- an electronic control unit (50; 150);

- at least one first sensor (30; 130) provided at said recess (1 1 ; 11 1 ) of the container body (10; 110) and configured to detect the insertion of the vial (40) inside the housing recess (1 1 ; 11 1 ) and to transmit a respective first signal (s₃o) to the electronic control unit (50);

- at least one second sensor (31 ; 131 ) arranged between said container body (10; 1 10) and said cap (20; 120) and configured to detect the opening/closure of the cap (20; 120) and to transmit a respective second signal (s_3i) to the electronic control unit (50); and

- signaling means (32; 132) for the user, which can be activated by the electronic control unit (50; 150) upon receiving of said first signal (s₃₀) and said second signal (s_3i) by the electronic control unit (50; 150) and based on dosage data (d_p) of the drug (F) which can be stored in the electronic control unit (50; 150).

2. A case (100; 1 100) according to claim 1 , wherein said first sensor (30; 130) is placed at a bottom (13) of said recess (1 1 ; 1 11 ).

3. A case (100; 1100) according to claim 1 or 2, wherein said second sensor (31 ; 131 ) is placed at an aperture (17) of said recess (1 1 ; 11 1 ) or on an edge portion of said cap (20; 120).

4. A case (100; 1 100) according to any one of the preceding claims, wherein a gap (16) is defined between the container body (10; 1 10) and the recess (1 1 ; 1 11 ) for housing the vial (40).

5. A case (100; 1 100) according to any one of the preceding claims, wherein the cap (20; 120) has an inner wall (24), which, in the closed position of the case (100; 1 100), is suitable for receiving a neck portion (44) of the vial (40).

6. A case (100; 1 100) according to claim 5, wherein a plurality of longitudinal fins (21 ) are formed in said inner wall (24) of the cap (20; 120), said longitudinal fins (21 ) being suitable for embracing said neck portion (44) of the vial (40) in the closed position of the case (100; 1 100).

7. A case (100; 1 100) according to any one of the preceding claims, wherein said signaling means (32; 132) are acoustic, visual or vibration signaling means.

8. A case (100; 1100) according to any one of the preceding claims, further comprising a temperature sensor (34) placed in the container body (10; 1 10) or in the cap (20; 120), and signaling means (36), the temperature sensor (34) being configured to measure the temperature of the drug (F) and to transmit a temperature signal (S_T) to the electronic control unit (50; 150) and the signaling means (36) being able to be activated by the electronic control unit (50; 150) if the measured temperature of the drug (F) is greater than a preset preservation temperature (Tpreserv) of the drug (F).

9. A case (100; 1 100) according to any one of the preceding claims, wherein said electronic control unit (50; 150) comprises a storage unit (56) for storing the dosage data (dp) of the drug (F) to be administered, a processor (52) and a timer (54) which is controllable by said processor based on the signals (s₃₀, s_3i) transmitted by the first sensor (30; 130) and the second sensor (31 ; 131 ).

10. A case (100; 1 100) according to any one of the preceding claims, wherein said electronic control unit (50; 150) further comprises a wireless communication module (58) which is configured to communicate with a respective wireless communication module (72) of an external data processing device (70) so as to allow data to be exchanged between the case (100; 1 100) and the external data processing device (70).

11. A method for the controlled administration of a drug (F) carried out by using a case (100; 1 100) for a vial (40) according to any one of the preceding claims, comprising the steps of:

- positioning (S1 ) the vial (40) containing a drug (F) in a recess (1 1 ; 1 1 1 ) of a container body (10; 110) of the case (100; 1 100),

- detecting (S2) by means of a first sensor (30; 130) the insertion of the vial (40) in the case (100; 1 100); and

- signaling (S4-S5) to a user, by means of signaling means (32; 132) of the case (100; 1 100), the need to proceed with administration of at least one dose of the drug (F) according to drug dosage data (dp) which can be stored in the case (100; 1 100).

12. A method according to claim 1 1 , wherein said signaling step (S4-S5) comprises:

- determining (S4) an event of first administration of the drug (F);

- calculating (S51 ) by means of the electronic control unit (50; 150) a time interval (Atii _N+i ) between two subsequent administrations of the drug (F) which is stored in the electronic control unit (50; 150);

- activating (S52) by means of the electronic control unit (50; 150) signaling means (32; 132) of the case (100; 1 100) so as to alert the user that it is necessary to proceed to administer a subsequent dose of the drug (F).

13. A method according to claim 12, wherein said step (S4) of determining an event of first administration of the drug (F) comprises the steps of:

- checking (S42) for the presence of a cap closing event (Ci) within a preset time interval (At) and, if present, waiting (S43) for an event of first administration of the drug (F);

otherwise

- determining (S44) an event of first administration of the drug (F); and

- storing a first administration time (ti_-admin) in the electronic control unit (50; 150).

14. A method according to claim 13, wherein said step (S43) of waiting for an event of first administration of the drug (F) comprises the steps of:

- calculating (S46) a waiting time (t_wait) for a first administration event; and

- if the waiting time (t_wait) is greater than or equal to a preset threshold value (tw_aitthreshoid), activating (S47) by means of the electronic control unit (50; 150) the signaling means (32; 132) of the case (100; 1 100) so as to alert the user that it is necessary to proceed with the first administration of the drug (F);

otherwise

- determining (S44) (31 , 131 ) an event of first administration of the drug (F); and

15. A method according to any one of claims 12 to 14, wherein said steps of calculating (S51 ) the time interval (DΪ_N-N+I ) between two successive administrations of the drug (F) and activating (S52) the signaling means (32) are repeated a number (n1 ) of times equal to the number (N) of daily administrations of the drug (F) indicated by dosage data (d_P) stored in the electronic control unit (50; 150).

16 A method according to any one of the claims 1 1 to 15, wherein said step (S4- S5) of signaling to a user to proceed with administration of at least one dose of the drug (F) is repeated a number (n2) of times equal to the duration (D) of the prescribed therapy provided by dosage data (dp) stored in the electronic control unit (50; 150).

17. A method according to any one of claims 1 1 to 16, further comprising a step of checking for the temperature of the drug (F) contained in the case (100; 1 100), said checking step comprising:

- detecting the temperature of the drug (F) by means of a temperature sensor (34);

- transmitting a temperature signal (S_T) to the electronic control unit (50; 150);

- comparing the received temperature signal (S_T) with a preset temperature value (T_preserv) for correct preservation of the drug (F); and

- if the received temperature signal (s_T) is greater than the preset temperature value (Tp_reserv), activating signaling means (36; 136).

18. A method according to any one of claims 1 1 to 17, further comprising upstream of the step (S2) of detecting the insertion of the vial (40) inside the case (100; 1 100), a preliminary step of storing in the electronic control unit (50; 150) the dosage data (dp) of the drug (F) to be administered, said preliminary step comprising the steps of:

- acquiring the dosage data (dp) from an external data processing device (70);

- transmitting the acquired dosage data (dp) to the electronic control unit (50; 150) of the case (100; 1 100); and

- storing the received dosage data (dp) in the electronic control unit (50; 150).