Disclosed is a medicament dispenser (1) for delivering a medicament (9, 53) to a user (2), the medical dispenser (1) comprising one or more internal storages (3, 52) for storing one or more medicaments (9, 53); a dispensing unit (10, 101) configured to access said one or more internal storages (3, 52) and dispense the medicament (9; 53) based on a predefined dispensing protocol (18); a control unit (13) comprising a user recognition unit (12, 19), adapted to collect user authentication data (76); and a communication module (14), configured to send/receive said user authentication data (76) and a delivery control data (16) associated to said predefined dispensing protocol (18) to/from a remote server (15); wherein said control unit 5 (13) is configured to enable/disable said dispensing unit (10, 101) based on said user authentication data (76) and said delivery control data (16). Also disclosed is a medicament re-filling apparatus (32) for the use with a medicament dispenser (1) upon authentication and validation of its user (2) condition.

The present invention relates to a medicament dispenser for delivering a medicament to a user.

BACKGROUND OF THE INVENTION

In medicine there is often the need to control and/or monitor correct intake of medication, such as drugs and medicine which are typically prescribed for conditions concerning the nervous system, especially the brain, peripheral nerves, and spinal cord, due to a broad scope of medical situations. Within this scope there are drugs and medicine described and listed by FDA (United States Food and Drug Administration) as Neurology Drugs and Nervous System Drugs, including medication for pain relief purposes, such as opioids, and for which there is the need of rigorous control and monitoring of related effects. Concerning medicines for pain relief purposes, like opioids, those will be referred in this document their four subcategories: opiates, semi-synthetic opioids, synthetic opioids, and endogenous opioids.

Drugs and medicine described above may have a large spectrum of applications for different types of patients' conditions concerning, but not only, post-surgery, cancer treatments, as well as brain and nervous system conditions such as: Alzheimer's Disease, Attention Deficit Hyperactivity Disorder (ADHD), Carpal Tunnel Syndrome, Huntington's Disease, dementia, memory loss, multiple sclerosis, muscular dystrophy, Parkinson's Disease, Tourette's Syndrome, and others, which they all require to careful follow related prescription and its effects.

FDA list of approved drugs for neurology and the nervous system includes a plurality of types of such medication supposed to be prescribed to patients by their medical doctors, as such medicines are considered “prescription drugs” or “prescription strong medicines”, which include:Opioids, as Opiate pain relievers, such as methadone, morphine, oxycodone (OxyContin), fentanyl, sufentanil, levorphanol, oxymorphone, hydromorphone, meperidine (Demerol), and tramadol, as well as any chemical variation or combination of those;Medicines that can be prescribed to be used with opiate pain relievers. Such medicines are usually prescribed to help pain medicine performance treating patient's symptoms, or they are specifically prescribed for certain types of pain. These medicines include, but not only: Bisphosphonates (e.g. dexamethasone, and prednisone), Anti-inflammatory drugs and corticosteroids, local anesthetics (e.g. lidocaine, and capsaicin, to help pain in skin and surround tissues), Anticonvulsants, Antidepressants, and other medicines aiming to have similar effects.
The medicines described above are given to patients in several ways depending of the specific conditions of each patient, and in general they are given by mouth. Although, in several circumstances, for example when the patient may have difficulties, or related problems, in swallowing capsules, these types of medicines may be taken in several other ways, including in cases when faster pain relief is needed.

In general, there are the following common ways of taking these medicines:

a) By mouth: such as pills, capsules, tablets, liquids, and medicines that dissolve on the tongue or under the tongue, as well as through aerosol to be absorbed via the mouth and respiratory system into the body;

b) Using skin patches: the patch has medicine incorporated that is absorbed into the body through the skin;

c) With rectal suppositories: such as in pills, or capsules, which are put inside the rectum and absorbed into the body;

d) With needles: such as injections, or into a vein (IV—intravenous). A patient taking medicines via IV may be able to use a Patient Controlled Analgesia (PCA) pump, which lets the patient control pain medicines in some limited ways;

e) With infusion pumps, as pain relief pumps: which are placed under the skin of the patients to deliver pain medicine directly to their spine;

f) Into the spine: when medicine is put into the area around the spinal cord, such as with epidural or spinal anesthesia.

Taking into consideration that the ways d), e) and f) require support from third parties, namely certified health professionals or others equivalent, for the first set-up as well as for further control and monitoring, ways a), b) and c) are manners commonly used when patients have conditions of total or partial autonomy.

Due to the specificity of these types of medicines there are potential problems and risks to the patients that are associated to hazardous situations of its misuse, including those of not following defined medical prescription, and which may occur by the following main failure modes:Lack of self-control of the patient on the frequency and/or quantity of intake of the specific medicine or pharma product containing opioids to be administrated according medical prescription;Deliberately wrong intake by the patient of the specific medicine or pharma product containing opioids, out of the quantity and/or frequency as medically prescribed;Unconscious intake, or deliberately conscious intake, by individuals which are not the intended patient and user of the specific medicine or pharma product according medical prescription.
Such main failure modes described above can directly, or indirectly, cause situations that may put in danger the life of individuals that take the medicines or pharma product containing opioids, as well as it may put in danger the life of other individuals that may directly, or indirectly, be affected by any conscious, or unconscious, action of misconduct in any circumstances of such person, including wrong action, or lack of action, on professional duty. These are problems that manufacturers and medical authorities that prescribe related medicines or pharma products, or devices that deliver such products currently on the market, could not yet solve in a robust and reliable way, and accidental intakes of such products keep often occurring in an increasing and alarming way, as published statistics by governmental and independent health authorities show. Just referring to U.S.A., according to governmental official data of Centers for Disease Control and Prevention, “overdose deaths involving prescription opioids have quadrupled since 1999, and so have sales of these prescription drugs. From 1999 to 2015, more than 183,000 people have died in the U.S.A. from overdoses related to prescription opioids, in 2014 around 2 million Americans abused or were dependent on prescription opioids, and every day, over 1,000 people are treated in hospital emergency departments for misusing prescription opioids”.

The main failure modes leading to related to prescription strong medicines also apply to any other medicine drugs or pharma products, with strong effect in human body for specific medical purposes which are mostly taken by mouth, such as pills, capsules, tablets, liquids, or aerosols, and which require proper control and compliance with the prescribed doses and intake scheduling.

As explained, due to several reasons, including social and cultural factors, the intake of the several types of medicines described above is often not compliant to the prescription, resulting in serious health problems to those affected, including death, and every year thousands of such cases are reported by national health authorities worldwide. This reality affects mostly developed countries, in particular United States of America, Canada, European Union, Japan, and other countries, also following a worldwide trend of increasing elder population, and related consumption of prescribed pain relievers medicines.

SUMMARY

Purpose of the present invention is to overcome the above-mentioned drawbacks by providing a medicament dispenser as substantially defined herein.

Further object of the present invention is to provide an auxiliary device as substantially herein.

Further object of the present invention is to provide a medicament re-filling apparatus as substantially defined herein.

Further objects of the present invention is to provide an inhaler as substantially defined herein.

Further object of the present invention is to provide a medical system as substantially defined herein.

Further preferred characteristics are defined in the corresponding dependent claims.

According to a first aspect of the present invention, it is provided a medical dispenser for delivering a medicament to a user, the medical dispenser comprising:

one or more internal storages for storing one or more medicaments;

a dispensing unit configured to access the one or more internal storages and dispense the medicament based on a predefined dispensing protocol;

a control unit comprising:a user recognition unit adapted to collect user authentication data; anda communication module, configured to send/receive user authentication data and delivery control data associated to said predefined dispensing protocol to/from a remote server;
wherein the control unit is configured to enable/disable the dispensing unit based on user authentication data and delivery control data.

In an exemplary embodiment, the communication module is configured to send/receive the delivery control data and the user authentication data through wireless means.

In an exemplary embodiment, the control unit is further configured to collect health data associated to the user.

In an exemplary embodiment, the communication module is further configured to send/receive the health data to/from the remote server, the delivery control data being adjusted based on the user health data.

In an exemplary embodiment, the communication module is configured such to send/receive the health data through wireless means.

In an exemplary embodiment, the medicament dispenser comprises a camera for detecting user's visual data associated to user's physical characteristics, the control unit being configured to process the visual data such to obtain the health data. The camera can also be used to timely perform pupilometry and correlate with the effects of medicine intake.

In an exemplary embodiment, the control unit is configured to receive/send health data associated to the user from/to an auxiliary external device.

In an exemplary embodiment, the internal storage is an elongate compartment having a top end and a bottom end, the elongate compartment being adapted to accommodate a plurality of medicaments in the form of a pile.

In an exemplary embodiment, the dispensing unit comprises an ejector configured to slide along a transversal direction R with respect to an axis A of the elongate compartment, the ejector being slidable from an inner position where it collects a medicament located at the bottom end of the compartment to an outer position where the ejector protrudes out of the dispenser to deliver the medicament and vice/versa.

In an exemplary embodiment, the medicament dispenser comprises a resilient means located at the top end of the compartment, the resilient means being arranged to exert a pressure on the pile such to ensure that the medicament located at the bottom end of the compartment is intercepted by the ejector for delivery when the latter is in the inner position.

In an exemplary embodiment, the medicament dispenser further comprises a blocking device associated to the ejector, the blocking device being adapted to prevent/allow a movement of the ejector when activated/de-activated by the control unit.

In an exemplary embodiment, the activation/de-activation of the blocking system is operated by the control unit based on the user authentication data and the delivery control data

In an exemplary embodiment, the activation/de-activation of the blocking system is operated by the control unit based on the health data.

In an exemplary embodiment, the ejector is connected to a slidable button located on an external wall of the medicament dispenser, the slidable button being operable by the user.

In an exemplary embodiment, the internal storage is configured to accommodate a canister that is adapted to store the medicament in a form such to be delivered as an inhalable aerosol.

In an exemplary embodiment, the dispensing unit comprises a movable shutter for allowing/preventing access to the canister.

In an exemplary embodiment, the movable shutter is connected to a slidable lever of the medicament dispenser and operable by the user.

In an exemplary embodiment, the canister comprises an upper component adapted to be connected to an inhaler, for inhaling the aerosol.

In an exemplary embodiment, the medicament dispenser comprises a cover for accessing the internal storage, wherein the cover is removably connected to a main body of the medicament dispenser by a locking/unlocking means.

In an exemplary embodiment, the locking/unlocking means is configured to cooperate for connecting/removing the cover with an external medicament re-filling apparatus, when the latter is located in physical proximity with the medicament dispenser.

In an exemplary embodiment, the medicament dispenser further comprises a safety clamping mechanism configured to irreversibly prevent unlocking of the cover.

In an exemplary embodiment, the safety clamping mechanism is activable by the control unit upon reception of a service termination order from the remote server.

In an exemplary embodiment, the safety clamping mechanism is associated to an internal electric circuit arranged to detect a local attempt of forcing the medicament dispenser to access the internal storage, wherein the safety clamping system is activated if such attempt is detected.

In an exemplary embodiment, the safety clamping mechanism comprises an electro-mechanical switch including a component having a slidable pin, the pin being arranged when activated to project into a receiving groove of the cover to prevent its removal.

In an exemplary embodiment, the medicament dispenser further comprises a destruction system of the medicaments.

In an exemplary embodiment, the destruction system is activable by the control unit upon reception of a service destruction order from the remote server.

In an exemplary embodiment, the destruction system is associated to an internal electric circuit arranged to detect a local attempt of forcing the medicament dispenser to access the internal storage, wherein the destruction system is activated if such attempt is detected.

In an exemplary embodiment, the destruction system comprises a reservoir disposed within the internal storage, the reservoir having frangible walls and containing a medicament-neutralizing agent.

In an exemplary embodiment, the medicament dispenser may comprise a puncher element configured to break, when activated, the frangible walls, wherein the reservoir is arranged within the internal storage such that upon breakage of the frangible walls the medicament-neutralizing agent is released within the internal storage.

In an exemplary embodiment, the destruction system comprises an electro-mechanical switch including a component having a slidable pin such that, when activated, the slide of the pin triggers a release of the puncher element for breaking the reservoir walls.

In an exemplary embodiment, the electro-mechanical switch is arranged such that the slide of the pin causes both its projection into the receiving groove of the cover for preventing its removal and the release of the puncher element for breaking the reservoir walls.

According to a further aspect of the present invention, it is provided a medicament dispenser for delivering a medicament to a user, comprising:a connector for connecting the medicament dispenser to an external storage adapted to store a medicament;a control unit comprising:a user recognition unit adapted to collect user authentication data; anda communication module, configured to send/receive said user authentication data and a delivery control data to/from a remote server, the delivery control data being associated to a predefined dispensing protocol of the user;
wherein the control unit is configured to enable/disable delivery of medicament from the external storage to the user based on the user authentication data and the delivery control data.

A further aspect of the present invention provides an auxiliary device for use with the medicament dispenser for monitoring health of a user, the auxiliary device being configured to collect health data of the user and to send/receive the health data to the medicament dispenser.

In an exemplary embodiment, the auxiliary device is a wearable device.

A further aspect of the present invention provides an inhaler for use with the medicament dispenser.

A further aspect of the present invention provides a medicament re-filling apparatus for use with the medicament dispenser.

In an exemplary embodiment, the medicament re-filling apparatus comprises a communication system configured to exchange validation data with the control unit of the medicament dispenser and/or a remote server for authenticating the medicament dispenser.

In an exemplary embodiment, the medicament re-filling apparatus comprises a base with a receiving slot for internally receiving at least a portion of the medicament dispenser.

In an exemplary embodiment, the communication system is configured to exchange validation data with the control unit and/or the remote server through wireless means.

A further aspect of the present invention provides medical system for a medicament intake and monitoring, comprising the medicament dispenser and the auxiliary device.

DETAILED DESCRIPTION OF THE DRAWINGS

Making reference toFIG.1, it is schematically and synthetically depicted the present invention according to exemplary embodiments.

In particular, it is illustrated an exemplary embodiment of a medicament dispenser, according to the present invention, denoted with numeral reference1.

Medicament dispenser1enables real-time control and monitoring of medicine or drugs (in this document generally referred to as “medicament”) for a user2in accordance to a medical prescription, per each single delivery and per dose. It may also apply to pharmaceutical products in general as detailed above.

As it will be described in details in the following, the medicament dispenser1comprises means for communicating data with a remote server15.

The remote server15may be typically located in a hospital/clinic facility or in general at a location accessible to a doctor/medical staff180, as administrators of the device, or by automatic programmed decision making based on predefined situations, such to enable monitoring and/or control of single, or set, of deliveries and enabling the doctor/medical staff to know when the patient effectively took the defined/prescribed medicament, as well as monitoring the effects of such intake in patient's body.

The medicament dispenser according to the invention additionally enables the remote control and monitoring of exceptional deliveries of doses out of standard dose, as well as out of prescribed scheduled timing.

User2authenticates him/herself by inputting in the medicament dispenser1user authentication data76.

User2is associated to a dispensing protocol, generally indicated with numeral reference18. Dispensing protocol18includes a set of pre-determined rules tailored on the user's medical needs, such as type and quantity of medicament to be taken at a fixed time schedule. Dispensing protocol18is generally defined by the doctor based on user's medical conditions. In some embodiments, medicament dispenser1enables the dispensing protocol18to be remotely varied by the doctor/medical staff180based on the real-time remote monitoring of user's medicament intake. Based on the dispensing protocol18, a delivery control data16is elaborated and exchanged, along with user authentication data76, between the medicament dispenser1and the remote server15. Delivery control data16may generally be identified as a signal corresponding to medicament delivery instructions as well as stored information in the medicament dispenser1related to the occurred medicament delivery based on such instructions. Such data is sent/received from the medicament dispenser1to/from the remote server15to enable a real-time monitoring of the user's status.

Based on this monitoring activity, dispensing protocol18may be varied, and this may be reflected in the delivery control data16.

In some embodiments, user2may also communicate to the medicament dispenser1health data17relative to his current physical state. As it will be described in the following, such health data17may be collected through an auxiliary device or via the medicament dispenser1itself, collecting for example user's visual data20, for example by means of a camera as it will be described in the following. Health data17, along with user's visual data20may also be exchanged between medicament dispenser1and remote server15for remotely monitoring user's physical conditions related to medicament intake based on the current dispensing protocol18. Moreover, patient's conditions before and after medicament intake may be also monitored by pupilometry still by means of a camera.

In some embodiments, remote server15may establish to remotely terminate the delivery service via sending a signal corresponding to a service termination order40to the medicament dispenser1, which disables the delivery of the medicaments. Service termination order40may be triggered in case, for example, of recorded abnormal usage of the medical dispenser1or in case of detected worsening of user's physical conditions.

In some embodiments, additionally or alternatively, remote server15may also send a signal corresponding to a destruction service order46, which operates the internal physical destruction of the medicaments contained in the medicament dispenser1.

Hence, medicament dispenser1according to the invention assures that the deliveries of medicines, namely strong medicines such as opioids pharma products, or other similar pharma products used for similar purposes, only occur according to its specific medical prescription, in terms of dose per delivery, and its frequency, to the specific user as the known patient, recognized as so by the doctor/medical staff through the remote server15, as well as it enables to monitor and control such deliveries by one, or more, administrative authorized personnel that may also control the dose, and change it if necessary upon extraordinary situations which can be identified in real time, and assessed remotely while remotely accessing to health data of the user as patient. These core features enable that a third party such as a medical professional individual, or equivalent professional working in a clinic/hospital, may access critical health data of the patient and take the most adequate medical decisions towards his/her health and wellbeing in the specific situation, in a safe way, also enabling monitoring of the results of such decisions, and act accordingly in case of any exceptional abnormal situation.

Still with reference toFIG.1, in accordance to a further aspect of the present invention, it is illustrated a medicament re-filling apparatus32for use with the medicament dispenser1. Medicament re-filling apparatus32is configured to operate a re-fill of medicaments into the medicament dispenser1and it is typically located at authorized sites such as pharmacies or the like. To this aim, medical dispenser according to the invention is advantageously provided in the form of a portable device, which allows the use to conveniently carry it to the authorized site for re-filling operations.

More in particular, re-filling apparatus32is configured to exchange validation data35between the medicament dispenser1and/or the remote server15for running the necessary check for recognition of the medicament dispenser1, the user2and the pre-defined dispensing protocol18. If all the checks are successful, then re-filling apparatus32may send an authorization signal36to unlock the medicament dispenser1in order to allow the medicament re-filling operations.

With now reference toFIG.2, it is illustrated in more details the scheme ofFIG.1.

In some embodiments, medicament dispenser1may be configured to exchange data, such data comprising (but not limited to) control delivery data16, health data17, user's visual data20, service termination order40, destruction service order46, through wireless means. More in particular, known communication media may be used for the purpose, such as a Bluetooth and/or a Wi-Fi type of connections, an accessible Cloud storage on the internet or through smart devices connection, enabling communication between medicament dispenser1and remote server15. Similar types of communication interfaces may be used for authenticating the medicament dispenser1for re-filling operations: medicament re-filling apparatus32may exchange data with the medicament dispenser1and/or the remote server15through above-mentioned known communication interfaces.

It will be appreciated that those who are skilled in the art have the sufficient knowledge to implement such technologies into the present invention to enable data communication between, for example, the medicament dispenser1, the remote server15and the medicament re-filling apparatus32.

In some embodiments, user2may also be equipped with auxiliary devices, generally denoted with numeral reference21, configured to collect vital health data17from the user2. Auxiliary devices21may include a wearable device21, configured for such purpose. Advantageously, medicament dispenser1may also be provided together with an auxiliary device21in combination, in order to provide user2with a complete medical system.

It will be appreciated that such technology, namely wearable devices capable of monitoring the physical being of a user2by collecting characteristics such as the heartbeat, are known to those who are skilled in the art and a detailed description thereof will be omitted in the present document.

In some embodiments, auxiliary device21may exchange health data17with (but not limited to) the medicament dispenser1, the medicament re-filling apparatus32and the remote server15through wireless means, as detailed above.

With reference toFIG.3, it is shown a medical dispenser1in a lateral, front and top view according to an exemplary embodiment.

Generally, medicament dispenser1comprises a main body30and a removable cover29. In this exemplary embodiment, main body30internally includes a storage for storing medicaments.

Removable cover29is adapted to be removed only under pre-defined conditions, which will be better detailed in the following, to enable access to the internal storage of the medicament dispenser1and operate re-filling of medicaments.

In the embodiment shown as a non-limiting example, medicament dispenser1is configured to accept medicaments in the form of a tablet9.

However, still remaining within the inventive concept underlying the present invention, medicaments may have different forms other than tablets.

As a non-limiting example, medicament dispenser1may deliver medicament containing one or more active agents in the following forms:Solids: tablets and pills, compressed in any type of geometric shapes and sizes, including:coated tablets;multilayer tablets with combination of different active agents;chip tablets, smart tablets of any form, including IEM (Ingestible Event Markers);enteric coated tablets, including MUPS (Multiple Unit Pellet Systems);Powders: including as salts, in micro and/or nano particles sizes, including:inside capsules;encapsulated in micro-capsules in capsules;granulated as granules in capsules; andas free powder in canisters or cartridges, including with compressed air or gases.Liquids: in several viscosity and fluidity forms, including:in containers, including in blistered containers, canisters, and cartridges; andin capsules.

Liquid forms may be used for intravenous injection, or for inhaled aerosol route via the mouth, or mouth and nose.

Medicine in aerosol forms, namely produced by thermal aerosolization based on electrical resistive heat or induction heating systems, or nozzles dispersing liquids from pressurized containers, pumps or micro-pumps, as well as aerosols produced using ultrasound systems, may be used in case of patients requiring opioids for:the relief of dyspnea due to chronic pulmonary or cardiac disease;the relief of dyspnea due to primary or metastatic pulmonary neoplastic disease;the prevention or relief of pain due to neoplastic disease.

Concerning medication in tablet forms, depending of the targeted organ, or organs, where the active agent, or agents, are supposed to be delivered, absorbed and/or adsorbed, active agents in tables may be intended for standard use as tablets, including as dispersible tablets, as well as for sublingual intake.

Broadly speaking, medicament dispenser according to the present invention may use several types of medicaments, as consumables, including:One, or more, types of consumables with one, or more, type of active agent(s).

Example 1: a pain medicine, such as an opioid, as consumable “A” in a form of tablet, and a medicine to help pain medicine performance, as consumable “B”, such as a bisphosphonate (e.g. dexamethasone), in a form of tablet.

Example 2: a pain medicine, such as an opioid, as consumable “A” in a form of Film, dermatologic patch, and a medicine to help pain medicine performance, such as a bisphosphonate (e.g. dexamethasone), as consumable “B” also in a form of tablet.

Example 3: a pain medicine, such as an opioid, as consumable “A” in a form of tablet, in a dose of 10 mg, and the same or similar type of medicine in a form of tablet but with a stronger dose of 20 mg, as consumable “B”. Alternatively, such extraordinary dose may be of a lighter dosage of the same medicament, or a defined dose of a different medicament, as a complementary medicament, such as an analgesic, etc.

Still with reference toFIG.3, medicament dispenser1comprises a dispensing unit10. Dispensing unit10is configured to access the internal storage of the medicament dispenser1(not visible in the figure) and dispense the medicament9. In this exemplary embodiment, dispensing unit10comprises an ejector11which is connected to a slidable button23, manually operable by the user, to extract medicament9. As shown, slidable button23is located on an external wall24of the medicament dispenser23.

Making now reference to followingFIG.4, which shows a front view of the medical dispenser1, also revealing its internal parts.

More in particular, main body30of medicament dispenser1includes an internal storage, now visible and depicted with numeral reference3, for storing one or more medicaments9. In the exemplary embodiment shown, medicament dispenser1comprises two internal storages3, however it will be appreciated that the medicament dispenser1according to the present invention may comprise any number of internal storages. Description will follow relative to one storage, because the same description shall apply to any storage shall the dispenser1include more than one.

In this exemplary embodiment, internal storage3is in the form of an elongated compartment, having a top end5and a bottom end6. The compartment3is adapted to accommodate a plurality of tablets9in the form of a pile7.

Ejector11of dispensing unit10is configured to slide in a reciprocating fashion along a direction R, which is transversal to an axis A of the elongated compartment3. In the specific, ejector11is slidable from an inner position inside the main body30where it collects the medicament9located at the bottom end6, to an outer position where the ejector11protrudes out of the dispenser1to deliver the tablet9for user intake.

Advantageously, compartment3further includes a resilient means8located at the top end5such to exert a pressure on the tablet pile7and to ensure that the tablet9located at the bottom end6of the compartment3is intercepted by the ejector11when in the inner position for medicament delivery. Ejector11is operable by the user by a slidable button23located on the external wall24of the main body30. With reference to the figure, the slide of button23in the direction of the arrow causes delivery of a tablet, whilst a slide in the opposite direction is needed for loading the ejector of a tablet still within the pile7for a next delivery.

In the figure, it is depicted by way of example a normal tablet9and chip tablet91, including an ingestible event marker911.

In some preferred embodiments, medicament dispenser1may also comprise a sensor58adapted to detect presence of medicaments in the bottom position just before delivery for consumption. In case of usage of chip tablets91, sensors may also recognize those tablets91by chip reading/connectivity.

In some preferred embodiments, medicament dispenser1may comprise a microphone57for audio signal input, a loudspeaker59for audio output and a display54for enhancing/optimizing the user interface with the dispenser1.

Medicament dispenser1comprises a control unit13, powered by a power supply, such as a battery,55.

Control unit13includes a user recognition unit, generally indicated with numeral reference12, for collecting user authentication data. User recognition unit12may use different types of existing technologies for this purpose. In this exemplary embodiment, user recognition unit12includes a fingerprint reader for bio-metric authentication. Alternatively or additionally, user recognition unit12may include the display54, which may be equipped with touch-screen capabilities, for enabling the user to input a password and thus being recognized.

Control unit13further includes a communication module14configured to send/receive user authentication data and delivery control data associated to the predefined dispensing protocol to/from the remote server.

Control unit13is a processor which is adapted to receive/elaborate user's authentication data gathered from the fingerprint reader12and to drive the communication module14for sending/receiving delivery control data and user authentication data associated the predefined dispensing protocol to/from the remote server.

In this exemplary embodiment, communication module14is configured to send/receive delivery control data and user authentication data to/from the remote server through wireless means, as above explained. Control unit13further comprises a storage unit for storing historical data about medicaments delivery and consumption. Advantageously, historical data is also exchanged with the remote server15, in order to enable doctor/medical stuff to monitor the user's intake throughout his/her medical treatment.

In some preferred embodiments, medicament dispenser1may also comprise a camera19for detecting user's visual data which is associated to user's physical characteristics. In such embodiments, advantageously, control unit13may also be configured to process visual data in order to obtain health data of the user. For example, the degree of dilatation of the pupil, which may be controlled by camera19, may be an indication of the state of being of the user. Control unit13is adapted to enable/disable the dispensing unit10based on user authentication data and delivery control data exchanged with the remote server. Said differently, if user's recognition is not successful, and/or the dispensing protocol for the particular user does not include delivery instructions, then dispensing unit10is not be enabled for medicament delivery.

To this aim, with reference to this exemplary embodiment, medicament dispenser1comprises a blocking device associated to the ejector11of dispensing unit10, which is adapted to prevent/allow movement of the ejector11when activated/de-activated by the control unit13.

NextFIG.5shows an exemplary embodiment of a blocking device associated to the dispensing unit10.FIG.5shows a top-view section of medicament dispenser1. Particularly, two different exemplary embodiments are shown: on the left a medicament dispenser having two compartments where ejectors11are operable by slidable buttons23located on the same external wall24of the dispenser, and on the right a medicament dispenser having two compartments where ejectors are operable by slidable buttons23located on opposite walls of the dispenser, that is walls24and25. Description of blocking device will be directed to a single ejector11, and the same applies to all the ejectors11in any configuration.

Blocking device comprises a blocking pin22which is receivable into a correspondent hole positioned in the ejector11. Blocking pin22is movable between a delivery position, where it is released from the ejector11and allows its movement (driven by the user through slidable button23) to eject a tablet9(by movement in the direction indicated by arrow R), and a blocking position where it is inserted into the ejector hole, thus preventing its movement. Position of blocking pin is driven by the control unit, based on data collected by the user and exchanged with the remote server associated to dispensing protocol.

Alternatively, button23may be in the form of a rotatable knob. More specifically, its rotation may drive the slide of the associated ejector11to dispense tablet9as above detailed.

With now reference toFIG.6, it is illustrated the medicament dispenser1and schematically illustrated an exemplary usage thereof.

User2accesses the medicament dispenser1and authenticates his identity by input of his/her user authentication data76. In some embodiments, health data17collected by the wearable device21may also be input into the medicament dispenser. In some embodiments, medicament dispenser1may also be provided with a camera19for detecting user's visual data20. Control unit13collects user authentication data76and user health data17and exchange such piece of information through communication module14with the remote server15. Remote server15elaborates the information and, based on the dispensing protocol established with the user2, inputs control delivery data16. It will be appreciated that, based on current user's health data17, dispensing protocol18may be varied, thus affecting the delivery control data16. As an example, if health data17is considered abnormal, medicament delivery may be interrupted.

If all conditions are met and control delivery data16contains instructions for a medicament delivery, then control unit13de-activates blocking device of the ejector11. User2may act on slidable button24to guide extractor11out of the dispenser1and collect the medicament.

In some preferred embodiments, communication module14may further comprise a sub-unit configured to enable voice communication and/or text communication and/or video communication between the user2and the medical staff180, namely the doctor who is remotely monitoring the dispensing protocol18of the user2.

For example, sub-unit of communication module14may include a cellular module configured to enable a voice call and/or text messages and/or a video call over a cellular network between user2and the doctor180. Alternately or additionally, sub-unit may be further configured to enable communication over an internet connection, for example through a Wi-Fi type of connection.

Advantageously, the monitoring of the effective intake of the medicine, as well as the general medical conditions of the authenticated user2, may be possible by assessing the health data17acquired by the auxiliary external devices21interfacing with the medicament dispenser1.

Additionally or alternatively, the monitoring of the effective intake may also be assessed by a direct voice and/or visual remote interaction between the user2and the administrator180. Specifically, this is made possible by the sub-unit of communication module14enabling such type of remote communication.

Said differently, sub-unit of communication module14adds to the medicament dispenser1functionalities currently existing in known mobile phones.

This further technical feature is particularly advantageous in the following exemplary scenario.

User2may be in the strong need of an additional medicament intake, which may not be included in the current dispensing protocol18. He/she may have the option of directly contacting medical staff180by means of a voice or a video call, using the portable medicament dispenser1according to the present invention which is equipped with sub-unit of communication module14enabling a voice call. To this aim, the above-underlined portability of the medicament dispenser according to the invention is particularly useful because it enables the user to utilize the dispenser1as a normal mobile phone. In this way, user2may directly inform the medical staff180about the urge, and a decision may remotely be taken in a timely fashion. To this purpose, user2may be required to collect current health data17and send such data to the remote server15so that his/her physical state may be promptly evaluated by medical staff180. This may be achieved by collecting user's pupil characteristics via the camera19of the medicament dispenser1, as above detailed.

After health data17has been provided, a decision concerning an extra dose may be taken.

If a further intake is allowed, then it may be advantageous to require the user to collect health data17immediately after the intake of the extra dose and to send the latter to the remote server15.

The entire procedure may advantageously occur with the help of a voice communication between the user2and the medical staff180.

Furthermore, medicament dispenser1may advantageously also include a geo-localization system. Hence, location of the user2may easily be assessed by the medical staff180particularly in case of medical urgency, or in case of misuse of the dispenser.

With now reference to nextFIG.7, it is depicted the medicament dispenser1for a medicament re-filling operation. Medicament dispenser1, as already mentioned, comprises a main body30, including one or more storages for accommodating medicaments, and a removable cover29for accessing the storages. Removable cover29is connected to main body30by locking/unlocking means.

When cover29of the medicament dispenser1is removed, it enables the access to the compartment(s) that contain the medicaments, and therefore enabling to load the medicament dispenser with consumables for the first time as well as to reload/refill the dispenser with medicaments.

In some embodiments, locking/unlocking means associated to cover29may include RFID or AM/RFID, fitted with an ultra-high frequency (UHF) RFID antenna for use in AM EAS and AM RFID, used in common magnetic or electromagnetic systems for unlock and detach secured locking devices as well as in electronic tag surveillance. It will be appreciated that such locking/unlocking means is known to those who are skilled in the art, and in this document a detailed description thereof will be omitted.

Advantageously, locking/unlocking means is configured to cooperate, for connecting/removing the cover29, with the external medicament re-filling apparatus32, only when the latter is located in physical proximity with the medicament dispenser1.

Medicament re-filling apparatus32comprises a detaching system (not shown) adapted to cooperate with the locking/unlocking means of the medical dispenser1to lock/unlock the cover29, thus allowing access to the internal storages for re-filling operations.

Apparatus32comprises a communication system, schematically indicated with numeral reference34, to exchange, preferably through wireless means, validation data35with the remote server15and/or the control unit of the medicament dispenser1. Validation data35is needed to enable/disable the detaching system of the apparatus32and thus allowing removal of the cover29.

In some embodiments, re-filling apparatus32comprises a base37and a receiving slot38for internally receiving a portion of the medicament dispenser1. In this exemplary embodiment, detaching system is located within the receiving slot38which physically matches medicament dispenser1. A portion of medicament dispenser1including the cover29is inserted therein.

After insertion, communication system34of the apparatus32exchanges validation data35between the control unit13of medicament dispenser1and the remote server15, to authenticate the medicament dispenser1to be re-filled and to preferably also collect information about the associated dispensing protocol18, needed by the authorized personnel for completing the re-filling operations.

Detaching system is enabled/disabled based on the validation data35. More in the specific, if all checks are successful, detaching system is activated by an authorization signal36to unlock the cover29.

With reference to nextFIG.8, it is shown an example of re-filling operation. Two piles7of medicaments9are positioned on top of the cover29. Next, medicament dispenser1is positioned back on the cover29. Lastly, detaching system of apparatus32locks the cover29and the user may, at this point, leave the authorized site with the portable medicament dispenser1now re-filled with medicaments and ready to be used.

In some embodiments, making now reference to nextFIG.9, a pile7of medicaments9may be provided within a tubular cartridge60, suitable for insertion within the elongated compartment3, which may be manufactured, for example, in metallic or polymeric materials. Advantageously, pile7of medicaments9may be contained between a lower groove61and an upper groove63. Correspondently, compartment3comprises an upper projection62which enters, during insertion of pile7, into upper groove63such to stably hold the cartridge60therein.

Insertion of cartridge60into compartment3is depicted in sequence with reference to nextFIG.10. In the figure, it is clearly shown that insertion of cartridge60compresses the resilient means8until upper projection62enters into upper groove63. Insertion of projection62into groove63resembles a snap-fit type connection.

Making now reference to followingFIG.11, cartridge60is further equipped with a disarming ring64. As it will be shown in the following, disarming ring64is forced within cartridge60such to disable lower groove61and enable delivery of tablets9.

NextFIG.12shows insertion of cartridge60into compartment3of the medicament dispenser1. Resilient means8is compressed until upper protrusion62of compartment3fits into upper groove63of cartridge60. Subsequently, disarming ring64is put in portion in correspondence of lower groove61. At this point, disarming ring64may be forced into the cartridge60manually by the user.

Alternatively, in some exemplary embodiments, as illustrated in nextFIG.13, forcing of disarming ring64into cartridge60may be operated automatically during connection of the main body30to the removable cover29operated by the re-filling apparatus32, as detailed below. In the figure, which shows a front section of medicament dispenser1, cover29and apparatus32, the sequence of operation is shown from left to right.

Disarming rings64are firstly inserted in correspondence of lower groove64still without enlarging the cartridge60in a sufficient way such to allow delivery of the tablets. In this exemplary embodiment, cover29internally includes movable pins291which are free to project upward. Correspondently, re-filling apparatus includes within its receiving slot protrusions321. Next, main body30is connected to cover29. At this point, medicament dispenser is pushed inside the receiving slot of the re-filling apparatus32such to enable locking means for connecting the main body30to the cover29. At the same time, protrusion321push upwards movable pins291which in turn act on disarming ring64and force the latter into the cartridge60such to disable lower groove63. In this way, tablets may now be collected by dispensing unit10, namely the ejector, for delivery.

In some embodiments, with reference to followingFIG.14, medicament dispenser1may also comprise a safety clamping mechanism, generally denoted with numeral reference39, which is configured to irreversibly prevent unlocking of the cover29.

Safety clamping mechanism39may be activated by control unit13upon reception of the service termination order40sent by the remote server15. Such service termination order40may be sent to the medical dispenser1in response, for example, to abnormal health data received from the user. In some scenarios, doctor/medical stuff may decide to immediately interrupt medicament delivery to assess user's physical conditions, without the risk of further medicaments intake.

In this exemplary embodiment, safety clamping mechanism39comprises an electro-mechanical switch42, which includes a component431having a slidable pin43. When the pin43is activated, it irreversibly slides along direction of arrow B into a groove44located on a portion441integral to the cover29. The insertion of pin43into groove44prevents opening of the cover29.

More in the specific, slidable pin43is constantly subject to a resilient force and it is maintained in the position depicted in the figure, namely out of the groove44, by an electric circuit, schematically indicated with numeral41, which produces a force opposed to the resilient one and keeps it in balance. Upon reception of service termination order40, control unit13disables the electric circuit41.

In this way, resilient force determines the irreversible slide of pin43within the groove44and thus the permanent unlocking of the cover29.

In some embodiments, alternatively or additionally, the internal electric circuit41, may advantageously be arranged in the medicament dispenser1such to detect a local attempt of hacking for removing the cover29and thus accessing the medicaments for unmonitored and uncontrolled intake. Safety mechanism39is activated is such attempt is detected. In fact, electric circuit41is advantageously located at an interface between main body and cover29, and therefore an attempt of forcing the latter for its removal would cause breakage of circuit41and consequently the slide of the pin43within the groove44.

In some embodiments, with reference to nextFIG.15, medicament dispenser may comprise a destruction system45of the medicaments contained therein.

In some embodiments, destruction system45may be activated by control unit13upon reception of a service destruction order46from the remote server15.

In some scenarios, doctor/medical stuff may decide to remotely neutralize the medicaments contained in the medical dispenser, if there is a risk that user may be in some way capable of accessing its internal storage for uncontrolled and hence dangerous intake.

Destruction system45comprises a reservoir47disposed within the internal storage3, which has internal frangible walls48and contains a medicament-neutralizing agent49.

Destruction system45further includes a puncher element50which is configured to break, when activated, the internal frangible walls48and release the medicament-neutralizing agent49within the internal storage3, thus coming into contact with the medicaments and neutralizing the active principle.

In this exemplary embodiment, puncher element50is kept in balance between two opposed forces: a spring72which forces the puncher50in the direction of arrow S and a an opposed force exerted by a crank71which mechanically engages a step501of puncher50in correspondence of its upper end. Lower end of crank71abuts to a movable pin43of an electro-mechanical switch42. When the pin43is activated, it irreversibly slides along direction of arrow D. The slide of pin43causes crank71to remove engagement with puncher50and cease the force exerted to the latter to keep it in balance against spring force72. This causes a sudden slide of the puncher element50along direction of arrow S towards an impulse transmission element73, which is connected to the main body of the dispenser by a support74. The impulse is then transmitted towards the internal frangible walls48of reservoir47, thus causing release of neutralizing agent49in the storage and consequent destruction of medicaments.

More in the specific, slidable pin43is constantly subject to a resilient force and it is maintained in the position depicted in the figure, by an electric circuit, schematically indicated with numeral41, which exerts a force opposed to the resilient one and keeps it in balance. Upon reception of service destruction order46, control unit13disables the electric circuit41. In this way, resilient force determines the slide of pin43along direction of arrow D and thus the sudden movement of puncher50in the direction of arrow S.

In some exemplary embodiments, as depicted in the figure, electro-magnetic switch431may be advantageously arranged between the lower end of crank71and the portion441of cover29in correspondence of its groove44. In this way, service destruction order46causes both its projection into the receiving groove44for permanently preventing removal of the cover29, and the release of the puncher50for breaking the reservoir frangible walls48.

This arrangement may be particularly advantageous in case neutralizing agent49is harmful for the user. In this case, in addition to medicaments destruction, it is ensured that internal storage is still not accessible by the user to prevent user come into contact with neutralizing agent49.

In this exemplary embodiment, internal walls48of reservoir47define the internal storage3where the medicaments are accommodated and the reservoir47is therefore located around the storage3. However, other embodiments may be considered where, for example, reservoir is entirely contained within the internal storage and arranged such that its breakage causes release of agent49therein.

In this exemplary embodiment, reservoir internal walls48may be made of a material which may be transparent, and which is fragile under certain mechanical stress conditions, and which can be glass, such as normal glass, as silicate glass or similar, composed of approximately 75% silicon dioxide (SiO2), sodium oxide (Na2O), calcium oxide (CaO), and additives, as well as thermal treated glass to have defined physical mechanical behavior upon specific mechanical stress, such as breaking and fragmenting according to specific pattern, etc. The material of internal walls48can be made of other types of glass, such as fluoride glasses, aluminosilicates, phosphate glasses, borate glasses, and chalcogenide glasses, glass-ceramics, as well as it can be made of polymeric materials, or compounds, which have similar physical properties, namely a hard material that is normally breakable when submitted to mechanical stress within the range of force needed to break the material according to its specific material characteristics and its specific design in terms of its surface.

With reference to nextFIG.16, internal reservoir walls48may include pre-cut lines in one or more directions in order to facilitate breakage of the material. For example, internal walls48may be provided with diagonal/helical lines481, or crossing/diamond lines482, or longitudinal lines483.

Calculation of necessary force Ftto be applied by puncher50to the impulse transmission element73may be measured using a standard testing apparatus75, as illustrated inFIG.17. Such force may be comprised in the range 6 N to 120 N, preferably from 15 to 50 N.

With now reference to nextFIG.18, it is shown a further exemplary embodiment of the medicament dispenser1according to the invention. In this embodiment, the internal storage of the medicament dispenser, where medicament is stored, may accommodate a canister52which is adapted to store the medicament in a form such to be delivered to the user as an inhalable aerosol53. The main components of dispenser1are the same as the one already detailed, so the detailed description will be omitted.

In this embodiment, medicament dispenser1is couplable to an inhaler,51, which may be disposable or re-usable. To this aim, inhaler51includes an end portion511which is configured to be coupled to an upper component28of canister52for inhaling the medicament in form of the aerosol53.

In this exemplary embodiment, medicament dispenser1includes two independent canisters A and B, each one carrying a different type of medicament. However, it will be appreciated that medicament dispenser1may comprise canisters52in any number, for storing the same type of medicament53or, differently, each canister52may include a different type of medicament, depending on the specific user's dispensing protocol.

In this embodiment, similarly to previously described embodiment, internal storages of medicament dispenser1may be charged or refilled via the cover29with canisters52,

In this embodiment, the usage of two different types of medicaments advantageously enables the controlled delivery of each medicament independently, or with correlated delivery, according to the dispensing protocol, and in such cases the geometrical cross-section of the internal storages and related canisters' embodiments may differ between them to enable easier and safer recognition.

In this embodiment, medicament dispenser1may have aerosol producing components, such as a homogenizer chamber81which may have specific cross-section for the purpose of better homogenization of the aerosol, including axially converging towards the outlet, like conical funnel, or converging and diverging, like converging conical and diverging conical towards the outlet of the inhaler51. When the inhaler51is coupled with the medicament dispenser1via the upper component28(threaded, bayonet, or other) the inhaler cross-section may extend the feature and effect of homogenization chamber.

With reference to nextFIG.19, it is described an exemplary usage of medicament dispenser1according to this embodiment. User2accesses the medicament dispenser1and authenticates his identity by input of his/her user authentication data76. Health data17collected by the wearable device21may also be input into the medicament dispenser1. Control unit13collects user authentication data76and user health data17and exchange such piece of information through communication module14with the remote server15. Remote server15elaborates the information and, based on the dispensing protocol established for the authenticated user2, inputs control delivery data16. It will be appreciated that, based on current user's health data17, dispensing protocol18may be varied, thus affecting the delivery control data16. As an example, if health data17is considered abnormal, medicament delivery may be interrupted.

In this embodiment, dispensing unit101comprises a movable shutter26, movable by the user2through a slidable lever27, to access internal storage which contains canisters52provided with a medicament in a form such to be delivered as inhalable aerosol for medicament intake.

If all conditions are met and control delivery data16contains instructions for a medicament delivery, then control unit13enables opening of shutter26with slidable lever27. Once shutter26has been opened, user may connect the inhaler51to the medicament dispenser1by coupling end portion511of the inhaler51to the upper component28of the dispenser1, as clearly shown in the figure. In this configuration, medicament dispenser1is ready to be used and deliver predefined doses of inhalable gas to the user in accordance to the predefined dispensing protocol.

In such cases of medicaments (for example opioids) in aerosol forms, those aerosols may be produced by thermal aerosolization based on electrical resistive heat or induction heating systems, or nozzles spraying or dispersing liquids from pressurized containers, pumps or micro-pumps, as well as aerosols produced using ultrasound systems. In any case of the use of the aerosols, for example opioids based pain relief medicine, medicament dispenser1is advantageously provided with metering capabilities to assure the delivery of a specified dose, such as using metered pump aerosolizing devices which deliver a fixed volume. In the case of the medicament dispenser using thermal aerosolization systems, such as electrical resistive heat or induction heating systems using canisters/cartridges with liquid forms of medicine for the purpose of thermal aerosolization, a reliable way of metering the dose and control the delivery may be obtained by controlling the time of activation of the heating unit, and therefore knowing the volume of liquid consumed in such activation and therefore the aerosol produced and inhaled by the user. In this way, control unit13of dispenser1controls the delivery and consumption of the medicament, and the effective consumption, in accordance to the dispensing protocol18. As already mentioned, general condition of user2and the effects of the specific consumption can be monitored remotely by the doctor/medical stuff via heath data17, including via pupilometry, using camera19of the medicament dispenser1to obtain data related to the status of the pupila of the user before and after the intake of the medicament.

With reference to nextFIG.20, it is shown yet a further embodiment of medicament dispenser1. In this example, medicament dispenser1includes two internal storages3, wherein one storage3accommodates a canister for medicament delivery in the form of inhalable aerosol, while the other storage3is configured to store tablets9in the form of a pile7.

This embodiment enables the use of controlled delivery of tablets9for a specific medicament, as well as the controlled delivery of a medicament to be inhaled via aerosol, such as opioids. This embodiment is therefore very advantageous in cases of users suffering debilitating dyspnea and sever bronchogenic, where opioids administered in aerosol form can be effective pain relief, including users with lung cancer, strongly supporting those patients in cases of gradual deterioration in quality of life.

Each storage of medicament dispenser1according to this embodiment operates as previously described, so a further description of such hybrid embodiment of the medicament dispenser will be omitted.

Broadly speaking, medicament dispenser1according to the invention may comprise any number of internal storages for storing medicaments, wherein each medicament stored in the respective storage may be provided in any forms and/or types.

Making now reference toFIG.21, it is depicted yet a further embodiment of the medicament dispenser according to the invention, indicated with numeral reference200. In this example, medicament dispenser200comprises a connector203for connecting the medicament dispenser200to an external storage204, in turn adapted to internally store a medicament, indicated with numeral201in the figure. Medicament dispenser200further includes a control unit13which comprises a user recognition unit adapted to collect user authentication data76and a communication module14, configured to send/receive the user authentication data76and a delivery control data16to/from a remote server15, wherein the delivery control data16is associated to a predefined dispensing protocol18of the user2.

It will be appreciated that the main difference of this embodiment with previous embodiments above described resides in the fact that medicament storage204is no longer an inner portion of the dispenser200, but it is a detachable external component. In this case, control unit13is configured to enable/disable delivery of medicament201from the external storage204to the user2, when connected to the dispenser200, based on the user authentication data76and the delivery control data16.

In this example, connector203is a female slot adapted to engage with a male component206of the external storage204enabling stable and robust physical and electrical connection between the dispenser200and an external storage204which carries the medicament201.

In this example, external storage204may be configured for aerosol production and delivery trough a mouthpiece205, External storage204may comprise an independent power source, such us at least one battery, and electronics (not shown) interfacing with the electronics, namely the control unit13, of the medicament dispenser200(namely control unit13) and/or the auxiliary device21.

Alternatively, external storage204may use the electronics and power supply of medicament dispenser200.

In some embodiments, operative functions may be displayed on display54, which may also have touch-screen capabilities.

The present invention has hereto been described with reference to a preferred embodiment. It is to be understood that there may be other embodiments afferent to the same inventive concept, and all falling within the scope of protection of the claims below.