IT202300010233A1 - DEVICE FOR AUTOMATIC DISPENSING OF MEDICATIONS AT THE BED-SIDE IN HOSPITAL SETTINGS - Google Patents

Description

DEVICE FOR AUTOMATIC DISPENSING OF MEDICATIONS AT THE BED-SIDE IN HOSPITAL SETTINGS

State of the art

There are several known state-of-the-art devices configured for the delivery of drugs to patients, in the home or hospital setting.

One example is a commercialized device (Medication adherence solution, Philips Medication Dispenser) in which a dispenser is configured to receive a preloaded refill cartridge filled with unit-dose drug packs, and to remind patients with chronic conditions to take their medications at predetermined times. The preloaded drug refills are delivered directly to the patients' homes by a mail-order pharmacy. A second device, commercially known as the "Hero," allows multiple pills, loose and of a single drug, to be loaded into a device that then allows for automated dispensing.

Another example is the device commercially known as PIVOTELL ADVANCE, which contains 28 compartments for holding drugs, and at pre-set times the user is allowed, by turning the device upside down, to extract only the drug whose administration is scheduled at that moment. The mechanical configuration is such that the number of drugs that can be loaded is limited, and furthermore there is no possibility of sharing the use by more than one patient. Conceptually similar is the device known as MED-O-WHEEL or the devices commercially known as Med-Elert's or as TUNSTALL MEDICATION DISPENSER

A device known as MED-MINDER allows the dispensing of preloaded pills via trays inside the device.

These, and other similar devices known to the state of the art, are devices optimized for home use, and do not allow the automated delivery of multi-drug therapies to a plurality of patients in a hospital setting.

Even in the patent field, various ways of realizing devices for the automatic dispensing of drugs are described.

US20190130078 and US20210030626 describe devices equipped with a single reservoir for drugs, with the consequent impossibility of distinguishing between pills of different types. US10292906 describes a device configured to contain each multi-drug dose within a single reservoir compartment. This makes it impossible to both modify the therapy during the course of the procedure (since the therapy has already been preloaded) and to trace any errors in the composition of the therapy. Furthermore, it does not allow the traceability of individual pills or tablets, for their subsequent reuse. Similar limitations are present in the US11166879 device.

Similar disadvantages are present in US8068934, which also has a mechanical complexity. The device has a plurality of loading holes (one for each drug) that complicate the loading phase for the nurse, adding a possible source of error. Furthermore, the pills are inserted without blisters, leading to possible problems of drug conservation.

EP2355769 describes a device in which pills are organized in preloaded columns, with the possibility of dispensing only the pill that is in the lowest position in the column and therefore without any possibility of selecting the individual pill. US20210361531 describes a device for extracting pills from their blisters, which requires many manual actions by the user (there are several buttons, for cutting, moving the blisters, etc.).

Technical problem

None of the drug delivery devices known to the state of the art allows for the simultaneous achievement of all of the following advantages: ease of loading by the nurse; management of multiple drugs of different types; management of the therapy of multiple patients; traceability of the operations performed by the nurse and of the correct intake of the therapy by the patients; individual traceability of each single drug, also for the purpose of subsequent reuse; possibility of using drugs both loose and inside blisters; possibility of modifying the programmed therapy without having to empty the device.

Ultimately, none of the devices known to the state of the art allow for effective use in a hospital setting, where all these problems take on significant proportions, but are all limited - in essence - to exclusively domestic use.

Purpose of the invention

The present invention therefore concerns an automatic drug delivery system in a hospital setting that allows the preparation of single-drug and multi-drug doses for the administration of personalized therapies, which allows the traceability of the drugs contained in the device as well as the administration of the therapy, and a simple and rapid management of changes to the therapy in progress.

The aim of the invention is also to provide an automatic drug dispensing system in a hospital setting that allows, thanks to a unique identification of the drugs, the recovery of all the medicines loaded into the device at the time of the patient's discharge.

Furthermore, the purpose of the present invention is to provide a device that allows both the dispensing of "loose" drugs and of drugs contained within their own blisters, possibly pre-cut.

According to yet another purpose, the invention intends to provide an automatic drug dispensing system in a hospital setting that allows the traceability of the operations performed by each operator, of the medicines loaded and still present in the device, of the status of the device and of the dispensing performed, and of compliance with the planned therapy by each patient.

Brief description of the invention

The invention achieves the intended purposes since it is a device for the automatic storage and dispensing of drugs comprising: a drug warehouse (10) comprising a plurality of discs (101), each disc (101) comprising a plurality of compartments (1012) open at the top and equipped with an opening bottom, and a compartment (1013) without a bottom, said discs (101) being superimposed on each other in a coaxial manner and configured to be able to rotate with respect to each other, so that when said compartments (1013) without a bottom are superimposed on each other, a loading/unloading channel for the drugs is obtained, passing from the top to the base of said warehouse (10); a casing (1) equipped with a front opening (13) protected by a door (11) through which said drug warehouse (10) can be opened. be inserted inside said casing (1), and an upper opening (12), through which the drugs can be inserted into the magazine (10); a removable container (2) for collecting the drugs to be dispensed to the patient positioned inside said casing, underneath said drug magazine (10) and in correspondence with said upper opening (12), said door (11) being configured in such a way as to allow, even when closed, the extraction of said container (2) through a drug access area (111); automatic protection means for said drug access area (111) and said upper opening (12); an actuation system configured to allow the individual and independent rotation of each disc; control means configured to control: the opening of said automatic protection means for said drug access area (111) and said upper opening (12), said actuation system for the rotation of the discs and the opening of said compartments (1012) equipped with an openable bottom.

Description of the invention

The integrated system according to the invention comprises:

- At least one dispensing device (automatic dispenser), and preferably a plurality of dispensers;

- At least one wearable device (preferably a vibrating bracelet), uniquely associated with a respective patient;

- At least one main electronic control and management device (tablet or PDA or smart phone) for system management.

Preferably but not limited to, the system also includes at least one wearable device (preferably a vibrating bracelet or smart phone) associated with a healthcare professional.

The system also includes computer programs, loaded onto respective electronic computing devices and accessible via remote communication, and configured to manage the devices present in the system.

Figure 1 shows the scheme of logical connections between the various components of the system, in a preferred way of implementation.

From a logical point of view, the computer programs will preferably be cloud-based (i.e. installed on a remote processing device), and connected via a network connection with all the other nodes of the system, according to a "star" architecture. Data processing will therefore take place at a centralized level, with unilateral (from the platform to the bracelets) and bilateral (towards the dispenser, the tablet and third-party applications) exchange of commands and controls.

In a preferential way of implementation, computer programs are configured to allow the following exchanges of information between the various devices that make up the system.

1: Information exchanged between the electronic computing devices and the dispenser (and vice versa):

? Therapy: sequence of drugs and times of administration

? Therapy delivered correctly

? Therapy correctly taken from the dispenser

Therapy not delivered correctly

? Therapy not taken correctly

Dispenser battery low

? Other self-diagnostic signals of the dispenser, to be defined in detail

2: Information exchanged between the electronic computing means and the main electronic control and management device

? Therapy planning: sequence of drugs and times of administration for each patient

? Barcode read by the tablet camera or by a specific barcode reader connected to the tablet, for the single drug during the loading phase of the dispenser ? Drug corresponding to a specific barcode

? Confirmation of delivery

? Confirmation of correctly pre-washed therapy

? Alarms:

o Therapy not delivered correctly to a particular patient o Therapy not collected correctly from a patient

o Low battery of a dispenser

o Other dispenser self-diagnostic signals, to be defined in detail 3: Information exchanged between the dispenser and each wearable device uniquely associated with a respective patient:

? Therapy ready to be collected.

4: Information exchanged between electronic computing devices and each wearable device associated with a healthcare professional

? Alarm signal on a dispenser

5: Information exchanged between electronic computing devices and third-party applications:

? Barcode acquired while loading a dispenser

? Drug on the market corresponding to a specific barcode Furthermore, it cannot be ruled out a priori that some specific data may flow through different channels (for example, the application for accessing the national drug database could be installed directly on the department's tablet).

Furthermore, it is important to note that, in the event that the scanned barcode is not present in the national drug database, it will be possible for the nurse logged in with his/her credentials to force the insertion of the drug into the dispenser, avoiding the blocking of the procedure in the event that the national database is not completely updated. Figures 2, 3 and 4 show the operating diagrams of the system in the loading, dispensing and unloading phases.

The computer programs that manage the system according to the invention are also configured to perform the drug loading, drug storage, drug dispensing and drug unloading phases according to the procedures illustrated below.

(1000) Drug loading and storage phase

(1010) Patient association: A device is associated with at least one wearable device associated with a respective patient.

(1020) Creation of the prescription: after authentication via username and password, a healthcare professional enters into the system, via the main electronic control and management device, the data relating to the therapy that must be followed by each patient associated with the device in step (1010) based on the medical prescription, indicating for each drug that each patient must take:

- Name of the drug

- Dosage to take

- Frequency of administration

(1020) Calculation of the total quantities of drugs needed to be loaded into the device based on the prescriptions entered in step (1020)

(1030) Loading of each drug into the device, according to the specific procedure described below

(2000) Delivery phase

In conjunction with the time of administration of a drug for a patient, When the digital platform detects that the time of administration of the therapy has arrived for a certain patient, it remotely activates the dispenser for that patient

The dispenser through its internal control system activates the dispensing operations of the first drug of the multi-drug dose. The sensors on board the dispenser detect whether the drug has been dispensed correctly within a certain period of time.

a. If the medication has not been dispensed correctly, an error message is displayed on the user interface of the tablet and at the same time the nurse's bracelet vibrates. The nurse, after having verified the nature of the problem on the tablet, must take care of administering the therapy

b. If the drug has been dispensed correctly and it is the last drug in the multi-drug dose to be dispensed, the dispenser emits a confirmation light signal and at the same time the patient's cuff vibrates. The patient must withdraw the entire therapy and take it

c. If the drug has been dispensed correctly and it is not the last drug to be dispensed, drug dispensing continues until the last drug has been dispensed. When the entire multi-drug dose has been dispensed, the sensors on the device (see below for a detailed description) check whether it has actually been taken within a certain period of time, and whether the container has actually been emptied before being replaced.

d. If the therapy has not been taken correctly, an error message is displayed on the user interface in the tablet and at the same time the nurse's bracelet vibrates. The nurse, after having verified the nature of the problem on the tablet, must take care of administering the therapy

e. If the therapy was successfully taken, a confirmation message will be sent to said at least one primary device.

Without this being limiting for the purposes of the invention, the message of administration could be sent to a software application that manages the medical record, in order to record the administration of the drug. In the event of a lack of connection between the central software and the individual devices (e.g., due to temporary network problems), the system is configured to:

- Recognize the disconnection state

- Notify staff of disconnection status and disconnection duration Based on this information, department staff will be able to implement manual verification procedures for medication administration.

(3000) Unloading phase

The device is also configured to completely unload the dispenser, for example after a patient is discharged, but it allows the recovery of the drugs contained therein, for their subsequent use in order to avoid waste for the hospital. For this purpose, the management software will provide all the information relating to the single drug unloaded (description, quantity and optionally batch and/or expiry date) and can be connected to a printer for adhesive labels, which will be used as per the procedure described below.

1. The nurse sets the start of the unloading function for a specific dispenser on the tablet;

2. The management software sends a command to the dispenser to unload the first drug (Drug A), based on the current filling status (which is known, as the loading and dispensing phases are tracked by the management software)

3. The management software sends the printer the command to print a label containing the information on Drug A: name of the drug, quantity and optionally batch and/or expiration date. If the printer is not present (as it will be an optional component), the nurse himself will have to fill in the labels by hand, copying the data that will be displayed on the tablet, if the drug is to be recovered.

4. All the stations containing Drug A are unloaded one by one with the same mechanisms that govern the dispensing. One pill of Drug A is unloaded at a time, until the dispenser contains no more.

5. The nurse places each pill of Drug A in a container (a plastic bag or box), and places the adhesive label on the container to ensure future tracking of the contents.

6. Steps 2 to 5 are repeated on all types of medication (Drug B, Drug C, etc.) contained in the dispenser.

7. At the end of the procedure, the containers marked with adhesive labels are put away so that they can be reused, taking into account the batches and expiry dates.

(4000) Therapy on Demand

According to a preferred embodiment, the device is configured to allow the patient to request the delivery of a given drug at a given time, through recognition by the bracelet and the pressing of a button on the device or other command voluntarily activated by the patient.

Depending on the different medications, regulations and therapeutic prescriptions, the department staff will be able to set maximum limits for the dispensing of pills as needed within certain time frames (e.g., a maximum of 2 dispensings as needed of the drug "X" in a 24-hour period). Each dispensing of the drugs as needed will be recorded in the centralized digital platform and notified on the department tablet.

Mechanical description of the dispensing device

The preferred embodiment of the device for storing and distributing drugs according to the invention is now described with reference to Figures 5 to 17.

Figure 5 shows the basic disk unit of the drug warehouse; figure 6 shows the disks of the drug warehouse stacked together; figure 7 a and b shows two views of the system for opening the trap door of the n-th sector of a disk; figure 8 shows the disk actuation system; figure 9 shows the system for extracting the disks from the casing; figure 10 shows a preferential embodiment of the wearable device; figure 11 shows a embodiment of the system for attaching the device according to the invention to the patient's bed; figure 12 shows a schematic view of the Pick and place system and the vision system; figure 13 shows a schematic view of the mechanical part inside the deblistering module; figure 14 shows a schematic sectional view of the system for conveying the deblistered drugs inside the input channel of the device; figure 15 shows a schematic view of the system for conveying the deblistered drugs inside the input channel of the device; shown is the deblistering device assembled on the dispensing device; in figure 16 is shown the device during drug dispensing, with the container accessible; in figure 17 is shown a schematic view of the arrangement of the main components inside the casing, with the casing not shown for graphic clarity.

As shown in figure 5, the basic unit of the drug storage unit consists of a rotating disk (101), comprising a central through hole (1011) and an external circular crown divided into a plurality of compartments (1012) of equal shape and size, open at the top and equipped, except for one, with an openable bottom. The compartment (1013) which is not equipped with an openable bottom is completely without a bottom, and therefore constitutes a through hole inside the surface of the storage disk (101).

The bottom door (10121) of each compartment (1012) is installed on the bottom of the compartment (1012) so that it can rotate around a horizontal rotation axis (10122).

The door is normally in the closed position, in which position it is maintained by a spring system that pushes it upwards. The door (10121) also includes a lever (10123) which, when operated by an external device, causes the door (10121) to rotate around the horizontal axis of rotation (10122), thus opening the compartment (1012). When the external action on the release lever (10123) ceases, a spring (not shown in the figure) returns the door (10121) to the closed position.

A plurality of discs (101) is stacked to form a magazine (10), as visible in figure 6. The drug magazine (10) is contained inside a casing (1), equipped with a front opening (13) through which the drug magazine (10) can be inserted inside said casing (1) and an upper opening (12), through which the drugs can be inserted inside the magazine (10).

The opening (13) for the entrance to the drug warehouse is closed by a door (11), shown in the open position in figure 9.

The door (11), when closed, also allows access to the drug collection area (111), so that this area can be accessed even with the main door (11) closed. The device (1) also comprises automatic closing means of said drug collection area (111), configured to prevent, when closed, access to this area and to allow access when open.

The device (1) also comprises a plurality of actuators (14), one for each of the discs in the magazine. Each actuator (14) is configured to activate or not, depending on its position, the release lever 10123) associated with the disc compartment which, at that moment, is in proximity to the actuator itself.

In figure 7-a an actuator (14) is shown in a distal position with respect to the disk. The disk is not shown for graphic clarity, and only the door (10121) is shown.

With the actuator in the distal position, the lever in that position the disc can rotate without any interference between the release lever (10123) and the actuator (14).

In figure 7-b, an actuator is shown in a position proximal to the disk. With the actuator in this position, the release lever (10123) intercepts the actuator (14) as a result of the rotation of the disk. The rotation of the disk thus causes the opening of the door (10121) closing the compartment (1012). The actuator (14) associated with each disk is positioned so as to intercept, when operated, the release lever (10123) of the compartment which at that moment is located in correspondence with the loading/unloading column.

The control means present on the device are configured to individually operate each of the actuators, selectively opening the compartment of each disc located in correspondence with the loading/unloading channel.

The opening sequence of the bottom compartment includes:

- Positioning the disc with the compartment to be opened in the position adjacent to that of the loading/unloading column

- Positioning of the relevant actuator in a proximal position to the disc - Rotation of the disc so that the compartment to be opened is brought into line with the loading/unloading column.

During the last rotation of the disc, the release lever intercepts the actuator, and the movement of the disc rotates the door (10121) around the horizontal rotation axis (10122).

As visible in figure 8, the shape of the housing (15) of each disc (101) is such as to allow for easy extraction by horizontal translation, in order to easily sanitise it.

In the embodiment shown in figure 5 each disk (101) is divided into 11 compartments (1012), however embodiments with a different number of compartments may be created without departing from the scope of the invention.

Preferably, furthermore, in order to optimize the use of space, the compartments (1012) will be in the shape of a sector of a circular crown.

Each compartment (1012) is configured to accommodate a single dose of a single medicinal product, in pill, loose tablet or pre-cut blister form.

As shown in figure 6 and already anticipated, the device according to the invention comprises a plurality of disks (101), overlapped coaxially and configured in such a way as to allow them to rotate with respect to each other. The set of disks therefore develops the drug magazine (10) vertically. Figure 6 shows the presence of 5 different disks (101), however, embodiments with a different number of disks may be used without departing from the scope of the invention.

The device further comprises an actuation system configured to allow the individual and independent rotation of each disc, and control means that allow to control such individual rotation means. Preferably the device comprises a plurality of electric motors (16), one associated with each disc (101) of the magazine (10) and configured to rotate the relative disc by means of a worm screw (161) that acts on a special toothed surface (1014) present on the external edge of the disc itself.

In particular, the control means are configured to cause each disk, via said actuation system, to perform multiple angular movements of the angular size of each compartment (1012).

Having anticipated that in each disk (101) there is a single bottomless compartment (1013), it is observed that when the disks (101), coaxially superimposed on each other, are rotated so that all the bottomless compartments (1013) are in turn superimposed, a vertical passage channel is formed, hereinafter also referred to as the loading/unloading channel or loading/unloading line. When the unloading channel is aligned below the upper opening (12) of the casing (1) - in a configuration hereinafter identified as the basic configuration - and the closing means of said opening (12) are in a position whereby said opening (12) is open, it is possible to introduce the drugs into the device. From the basic configuration, by keeping all the actuators (14) in a distal position and rotating a single disk so as to position a specific compartment of said disk below the opening (12), a configuration is obtained in which the drug inserted from above inside the device falls into the compartment (1012) located below the opening (12). The possibility of loading a drug into any compartment (1012) of any of the disks (101) has therefore been obtained.

It is in fact important to underline that each compartment can be identified individually by the number of the disk to which it belongs and the number of angular steps that the disk must move, with respect to the basic configuration, to bring that compartment in correspondence with the loading/unloading channel. In other words, a pair of numbers uniquely identifies each compartment in the warehouse.

The casing (1) of the device, in the upper part and in correspondence with the opening of the loading/unloading channel, comprises an opening (12) covered by a mobile closure equipped with appropriate actuation means.

This prevents the accidental insertion of pills, since the electronic control means of the device will allow the opening of this mobile closure only during the loading phase of the drugs.

Having described the construction of the disks, we can now explain how they work when loading the n-th sector of the k-th disk.

The magazine (10) is brought to its basic configuration, in which all the discs are rotated until their bottomless compartment is on the same line, thus creating a loading line in correspondence with the upper opening (12).

The k-th disk is then rotated to position the n-th compartment along the loading line. Since all the disks positioned above it have their own bottomless compartment along the loading line, the passage of the drug is guaranteed, which is inserted from above, through the special opening on the device casing.

It is specified that the device is preferably configured to open and close the opening in the upper part of the device before and after loading each single dose of drug, and to perform the movements of the storage disk, whether functional to loading or unloading the device, with all the openings of the packaging closed.

This measure minimizes the possibility of device jamming or incorrect loading of medications.

Similarly, the unloading phase is carried out by bringing the compartment containing the pill to be dispensed to the position adjacent to the one corresponding to the unloading line, while all the disks below it are rotated until their bottomless compartment is on the same line. The actuator (14) corresponding to the disk (101) on which the compartment (1012) to be opened is then activated, and subsequently the compartment (1012) to be opened is brought, by rotating the disk, to correspond to the unloading line. This movement causes the bottom (10121) of the compartment (1012) to open, and the drug contained within it falls along the unloading line, below which a container (2) is conveniently positioned to collect the unloaded drugs. As visible in figure 16, the container is located in correspondence with the drug dispensing area (111), which is made accessible to the patient after all the drugs of the multi-drug dose are present in the container (12).

The loading and unloading channels are appropriately sensorized in order to monitor the passage of the pills.

In a preferential embodiment, there are photocells (17) positioned in such a way as to detect the passage of the pills in the loading phases and photocells (17) positioned in such a way as to detect the passage of the pills in the unloading phases. Preferably the device also comprises a load cell (18) configured to detect the weight variations of the cup (2) as a function of its contents.

The control means of the device are configured in such a way that the withdrawal of the container (2) from inside the casing is only permitted by bringing the bracelet (3) worn by the patient close to the device (1), and after checking that the device brought close is the one associated with the patient who must take the prepared dose. The closing means of the drug withdrawal area (111) will then be unlocked, allowing access to the dose withdrawal area.

The same bracelet (3), as anticipated in the previous section, is configured to signal to the patient, by means of acoustic, luminous or vibrational signals, that in the device (1) there is a dose of drugs that must be taken. Above all, it is the device that lights up/sounds while the bracelet vibrates, but let's leave it to the latter to also light up or sound.

The drug collection area is appropriately sensorized in order to monitor the collection of drugs by the patient.

In a first embodiment, the device comprises a load cell (18) that detects the weight of the container (2) in which the drug is dispensed to the patient. Conveniently, the device is configured to calibrate said load cell before starting the dispensing phase and to weigh the container placed back by the patient again after dispensing, verifying its actual emptying by weighing.

In another embodiment, the device comprises a housing for the container (2) that allows the positioning of the cup only if aligned with said housing. The housing can be rotated 180? by means of the device's control means, so that when repositioning the container (2), the container must necessarily be positioned with the opening facing downwards, to ensure that it is emptied. In yet another embodiment, the device comprises a camera configured to frame the bottom of the container (2), and the device comprises electronic control means and related computer programs configured to analyse the image of the container, identifying the presence of drugs inside it. The access area will close once the patient has correctly repositioned the empty cup.

Preferably but not limited to, the device (1) also comprises a button accessible from the outside, and the device is configured to deactivate said acoustic or luminous signalling means only after the container (2) has been placed back in its place and the patient has pressed said button, thus confirming that the dispensed drugs have been taken.

Alternatively, the device is configured to send a message to the wearable device of the patient to verify drug intake following withdrawal of the container (2), and to deactivate said light or acoustic signalling means only following the sending by the patient, via said wearable device, of a response confirming that the dispensed drugs have been taken.

Deblistering device.

A preferred but non-limiting embodiment of the device is described below, also including a deblistering unit, configured to process entire blister packs of drugs without constraints on size and type of drugs.

The deblistering unit (200) includes:

- a pick and place system (201)

- a pill extraction station (202)

The pick and place system, shown in Error. The reference source was not found., is configured to extract blisters stored in a warehouse and place them in the work area of a vision system, which identifies the position of individual pills in the blister. The blister is then placed in the pill extraction station shown in Figure 13.

The system acts mechanically on the blister, extracting the single pill with a system of actuators having dimensions and shape appropriate to those of the drug. The extracted pills are conveyed into the input channel of the device as shown in Error. The reference source was not found.. In Error. The reference source was not found. the deblistering device assembled on the device is shown.

As anticipated, the device is configured in such a way as to be able to autonomously and automatically produce a multidrug dose (i.e. the administration of a plurality of drugs together).

Inside the device, the different drugs are stored individually in separate compartments, and discharged from time to time into a dispensing compartment at the time of scheduled administration or on-demand administration.

The device includes electronic calculation and control means and a user interface, which allow:

- When loading, associate each compartment with the relevant drug stored there;

- During use, to automatically and automatedly produce the dose of drugs to be administered to the patient.

At the scheduled time, the device prepares the dose (single-drug or multi-drug) by dropping all the drugs that are scheduled to be taken into the dispensing compartment.

Once the dose has been discharged into the compartment, the signalling means indicate to the user that the dose is ready to be taken.

In a first embodiment the signalling means comprise warning lights, in other embodiments the signalling means comprise acoustic signalling means, such as the reproduction of a pre-recorded sound or voice.

In a preferred embodiment, the device is equipped with remote wireless communication means, and proximity communication means (NFC), and further comprises at least one device wearable by a patient, equipped with respective remote wireless communication means and proximity communication means, as well as signalling means, such as means for vibrating the same. Preferably, the device comprises a plurality of wearable devices, each assigned to a specific patient.

In this embodiment, the device is configured to activate the signaling means of the wearable device associated with the patient who must take the dose of drugs delivered, to inform the latter of the need to take the dose.

The device also includes means for closing the compartment into which the dose to be taken is discharged, and said control means are configured to allow the opening of said closing means following identification, via said proximity communication means, of the correct wearable device. This allows the presence of the patient who is to take the dose to be ascertained at the time the dose is made available, substantially reducing the risk of incorrect administration.

In other words, following the activation of the signaling means, to access the dose the patient must bring his/her wearable device (for example a bracelet) close to the NFC reader on the device, which will allow access to the dose after identifying the wearable device.

Preferably, the device is configured so that reading the wearable device stops the beeping and vibration on the bracelet, while the indicator lights on the bracelet remain on until the dose is removed from the compartment where it was dispensed.

Preferably, the device is also configured to turn off the indicator lights only after the removable container into which the dose was dispensed is placed back in the dispensing compartment.

Once the procedure is completed, the light signal turns off and access to the dispensing compartment closes.

The device is also configured to allow the delivery of “on demand” or “as needed” therapy for those medications that need to be taken not at pre-established time intervals, but rather following the onset of specific symptoms.

For this purpose the device is provided with at least one button, or other equivalent means to allow the user to formulate a command.

In this way, to deliver the therapy "as needed", the patient independently brings the bracelet close to the reader and presses the button to deliver the pill as needed.

In this case too, the light comes on after the drug has been dispensed, and the light remains on until the patient has taken the dose and, if applicable, placed the cup back in the administration compartment, and then closed the access to the administration compartment.

As anticipated in the introduction, one of the peculiarities of the device according to the present invention is the possibility of using - in addition to "loose" drugs - also "blistered" drugs, that is, still sealed inside their own blister.

The drug delivery system comprises at least one device of the type just described (and preferably a plurality of devices of the type just described), and a main electronic device that allows its management, on which are loaded computer programs that allow the management of all associated devices. The management software can possibly be loaded on remote control means, which the main electronic device can access by means of authentication on an intranet or web network.

The main electronic device includes a barcode reader (possibly implemented via a camera and software tools that allow the identification of the framed barcode), so that during the loading phase of the drug, the drug being loaded into the system can be uniquely identified.

Preferably, the main electronic device also includes a QR code reader, so as to automatically acquire not only the type of drug but also additional information, such as the batch number and expiry date, where such information is available on the drug packaging.

The procedure for loading drugs into the device is now described.

This procedure can be performed, via the main electronic device, by an authorized user (typically a nurse) in possession of suitable access credentials. Once logged in, via the barcode reader, the authorized user proceeds to associate the device according to the invention (which is equipped with a unique identification code) to at least one wearable device (also equipped with an identification code) uniquely associated with a patient.

In this way, a one-to-one correspondence between patients and wearable devices is defined, and a one-to-many correspondence between the delivery device and wearable devices associated with the patients.

At this point, the authorized user sets, via the interface of the main electronic device, the therapy prescribed for each patient.

Please note that this therapy may, alternatively, be imported automatically from department management software where it has been entered by a doctor, or entered manually by an authorized user. These are the aspects of computer implementation that may be varied without departing from the scope of the invention.

Since the indication relating to the dosage, quantity and frequency has been provided, manually or automatically, for each drug, the type and overall quantity of each drug necessary to administer the therapies to the patients associated with the delivery device is therefore known.

At this point the authorized user can recognize the drug by reading the barcode or QR code.

After identifying the drug, the software displays the name of the drug on the user interface, positions the first compartment to be loaded in correspondence with the loading channel and subsequently opens the upper opening for loading the dispensing device, allowing the nurse to load a dose of drug, and then closes the upper opening.

The nurse loads, in the individual spaces assigned to them, the administrations (pills, tablets or other) of that drug as a whole foreseen by the therapies of the patients associated with the dispensing device, and inserts as input the information relating to the production batch and the expiry date of the drug.

Once this operation is completed, the software closes access to the first loading compartment and prepares for loading the second and subsequent drugs, which occur in a manner similar to that just described.

It is noted that loading the individual administrations of the different drugs in separate spaces, and each type of drug inside a separate compartment, allows the recognition (and therefore the reuse) of the individual drug (and the relative production batch and expiration date) in the event of the device being emptied due to therapy interrupted earlier than expected or modified during hospitalization, circumstances that occur very often. The possibility of reusing drugs loaded into the device but not used therefore constitutes a great economic saving for the hospital structure.

The device loading procedure, in case of new therapy or modification of the same, can also be carried out when the delivery device is already inside the patient's room, by using a portable main electronic device (for example a PDA or a tablet).

The dispensing device is configured to communicate with the main electronic device, sending alerts in at least one of the following circumstances: failure of the patient to collect the dispensed dose, failure to complete the dose-taking procedure, jamming, low battery, lack of signal, lack of pills, exhausted SIM, errors of any nature and absence of pills to be dispensed.

In a preferred embodiment, the system also comprises a wearable device (e.g. a bracelet) entrusted to the operator supervising the department (nurse on duty), equipped with remote communication means and configured to receive said alerts.

Preferably, the device also includes a visual signaling device (indicator light) that is activated when one of the circumstances listed above occurs. Preferably, said indicator light is of a different color than the light that lights up to indicate the availability of the dose to be delivered.

The dispensing device is also configured to communicate with the main electronic device, sending alerts whenever a single medication dispensing occurs.

The computer programs loaded onto the main device are configured to provide staff with reports on the quality of the administrations carried out for each patient (administrations on time, delayed, skipped, etc.), as well as reports that allow the traceability of the users who have operated on the system and of the individual loading operations performed.

Conveniently, the dispenser device according to the invention has small dimensions, with a base of approximately 20 cm in width and 15 cm in depth, and a height of approximately 30 cm, so that it can be easily positioned even on a bedside table.

The device also includes removable anchoring means, which allow it to be anchored to a horizontal surface (e.g. suction cups) or to the patient's bed or other support.

The device also includes means of power supply by battery or mains, and preferably also includes a back-up battery that intervenes in the event of a flat main battery or absence of mains voltage.

Claims (24)

Claims 1. Device for the automatic storage and dispensing of drugs comprising: - a drug warehouse (10) comprising a plurality of discs (101), each disc (101) comprising a plurality of compartments (1012) open at the top and equipped with an opening bottom, and a compartment (1013) without a bottom, said discs (101) being coaxially superimposed on each other and configured to be able to rotate with respect to each other, so that when said compartments (1013) without a bottom are superimposed on each other, a loading/unloading channel for the drugs is obtained, passing from the top to the base of said warehouse (10); - a casing (1) equipped with a front opening (13) protected by a door (11) through which said drug magazine (10) can be inserted inside said casing (1), and an upper opening (12), through which the drugs can be inserted inside the magazine (10); - a removable container (2) for collecting the drugs to be administered to the patient positioned inside said casing, underneath said drug storage (10) and in correspondence with said upper opening (12), said door (11) being configured in such a way as to allow, even when closed, the extraction of said container (2) via a drug access area (111); - automatic protection means for said drug access area (111) and said upper opening (12); - an actuation system configured to allow individual and independent rotation of each disc; - control means configured to control: the opening of said automatic protection means of said drug access area (111) and of said upper opening (12), said actuation system for the rotation of the discs and the opening of said compartments (1012) equipped with an opening bottom. 2. Device according to claim 1 characterized in that the bottom door (10121) of each of said compartments (1012) is installed so as to be able to rotate around a horizontal rotation axis (10122), is kept in the closed position by a spring system and also comprises a lever (10123) which, when operated by an external organ, causes the door (10121) to rotate around its own horizontal rotation axis (10122), thus opening the compartment (1012). 3. Device according to claim 1 or 2 characterised by the fact that it further comprises a plurality of actuators (14), one for each of said discs of said magazine, each actuator (14) being movable between a first and a second position and being configured to activate, depending on its position and following the rotation of the disc with which it is associated, said release lever (10123) associated with the compartment of the disc which rotates in proximity to the actuator itself. 4. Device according to one of the preceding claims characterised in that said control means are configured to perform a sequence of opening the bottom of one of said compartments which comprises the steps of: - Positioning of the disc with the compartment to be opened in the position adjacent to that of the said loading/unloading channel; - Positioning of the relevant actuator in a proximal position to the disc - Rotation of the disc so that the compartment to be opened is brought into line with the loading/unloading column and that during the rotation the release lever intercepts the actuator, and the movement of the disc causes the door (10121) to rotate around the horizontal rotation axis (10122). 5. Device according to one of the preceding claims characterised in that said compartments (1012) have the shape of a sector of a circular crown. 6. Device according to one of the preceding claims characterised in that each compartment (1012) is configured to accommodate a single dose of a single medicinal product, in the form of a pill, loose tablet or pre-cut blister. 7. Device according to one of the preceding claims characterised in that said actuation system comprises a plurality of electric motors (16), one associated with each disc (101) of the magazine (10) and configured to rotate the relative disc by means of a worm screw (161) which acts on a special toothed surface (1014) present on the external edge of the disc itself. 8. Device according to one of the preceding claims characterised in that said loading and unloading channel comprises sensors capable of detecting the passage of pills loaded inside the device or unloaded from the same. 9. Device according to claim 8 characterised in that said sensors comprise photocells (17) positioned in such a way as to detect the passage of the pills in the loading phases and photocells (17) positioned in such a way as to detect the passage of the pills in the unloading phases. 10. A device according to one of the preceding claims further comprising a load cell (18) configured to detect changes in weight of said removable container. 11. A device according to one of the preceding claims characterised in that it further comprises wireless remote communication means and proximity communication means. 12. Integrated system for the delivery of medicines comprising: - At least one device according to one of the preceding claims - At least one wearable device (3), uniquely associated with a respective patient and equipped with remote communication means and acoustic, light or vibration signalling means; - At least one main electronic control and management device for system management. - computer programs, loaded onto respective electronic computing devices and accessible via remote communication, and configured to manage the devices present in the system. 13. The system of claim 12 further comprising at least one wearable device associated with a healthcare provider. 14. System according to claim 12 or 13 characterised in that the control means of each device (1) are configured in such a way that said automatic protection means of said drug access area (111) are unlocked, allowing the withdrawal of said container (2), only by bringing the wearable device (3) associated with the patient who must take the prepared dose close to the device (1). 15. System according to one of claims 12 to 14 characterised in that said device comprises sensors configured to verify the actual emptying of said container (2) by the patient. 16. System according to claim 15 characterised in that said at least one device comprises a load cell (18) configured to detect the weight of the container (2) in which the drug is dispensed to the patient, in that the device is configured to calibrate said load cell before starting the dispensing phase and to weigh the container placed back by the patient again after dispensing, verifying its actual emptying by weighing. 17. System according to claim 15 characterised by the fact that said device comprises a housing for the container (2) which allows the positioning of said glass only if aligned with said housing, by the fact that said housing can be rotated by 180° by means of the device's control means, and by the fact that said control means are configured so that, during the repositioning phase of the container (2), the latter must necessarily be positioned with the opening facing downwards, to ensure its emptying. 18. System according to claim 15 further comprising a camera configured to frame the bottom of the container (2), and the device comprises electronic control means and related computer programs configured to analyse the image of the container, identifying the presence of drugs inside it. 19. A system according to one of claims 12 to 18 further comprising a deblistering unit, positionable above said device and comprising: - a pick and place system, configured to extract blisters stored in a warehouse and place them in the working area of a vision system, which identifies the position of individual pills in the blister; - a pill extraction station, comprising a plurality of actuators configured to extract a single dose of medication and drop it, through said opening (12), into said drug magazine (10) 20. System according to one of claims 12 to 19 characterised by the fact that within said at least one device the different drugs are in fact stored individually in separate compartments and also comprising electronic calculation and control means and a user interface, which allow during the loading phase to associate each compartment with the relative drug stored therein; 21. System according to claim 20 characterised in that said electronic means of calculation and control are configured in such a way that the device, at the time set for the administration of one or more drugs, drops all the drugs that are expected to be taken into said removable container (2), and in such a way that, after the entire administration has been discharged into said container (2), the signalling means present on said wearable device (3) indicate to the patient that the dose is ready to be taken. 22. A system according to one of claims 12 to 21, characterized in that said device is further configured to allow the delivery of "on demand" therapy for those drugs that must be taken not at pre-established time intervals, but rather following the onset of specific symptoms and comprises at least one button, or other equivalent means to allow the user to formulate a command and is configured to deliver a drug following the actuation of said command by the user. 23. System according to one of claims 12 to 23 characterised in that said device (1) comprises a button accessible from the outside, and is configured to deactivate said acoustic or luminous signalling means only after the container (2) has been placed back in its place and the patient has pressed said button, thus confirming that the dispensed drugs have been taken. 24. System according to one of claims 12 to 23 characterised in that said device (1) is configured to send to the device worn by the patient (3) a message verifying the intake of the drug following the withdrawal of the container (2), and is also configured to deactivate said light or acoustic signalling means only following the sending by the patient, via said wearable device (3), of a response confirming the intake of the dispensed drugs.