Patent Application
20200402631
The present invention concerns a system designed to monitor and/or control medication-taking by a patient.
More specifically, the present invention concerns a system designed to monitor and/or control the taking of medications in the form of pills by a patient.
The invention concerns also a method for managing said system for monitoring and/or controlling correct medication-taking by a patient.
Devices are known, which serve as an aid for the taking of medications by patients suffering from a disease.
Document U.S. Pat. No. 4,660,991 describes a device which is suited to be associated with a pack of pills, commonly known as blister pack. The device is suited to receive said blister pack and is capable of periodically warning the patient when he/she must take the medication, for example through an audio or video signal. The device is capable of detecting when the patient extracts the pill from the blister pack by means of suitable sensors and is capable of storing the time when the pills are taken, of displaying these values and, if necessary, of signalling that the pill has not been taken at the scheduled time.
Further pills detection systems are known from documents WO 2017/130207 A1, EP 3 061 438 A1, US 2017/004284 A1, US 2017/247401 A1 and WO 2012/136989 A1.
It is the object of the present invention to improve the systems of the known type in order to allow the correct taking of medications by patients and the control of said medication-taking.
It is another object of the present invention to propose a solution which allows third-party operators in addition to the patient, for example the doctor who prescribed said medications or a relative who takes care of the patient, to monitor and, if necessary, adjust the correct taking of medications by patients.
The present invention is based on the general consideration that it is desirable to provide a system for monitoring and/or controlling the taking of one or more medications packaged in a blister pack by a patient, said system comprising an identification unit that serves to identify the condition of the blister pack and the wireless transmission of the information regarding the condition of the blister pack to a service provider.
According to a first aspect of the present invention, therefore, the subject of the same is a system for monitoring and/or controlling the taking of one or more medications by a patient, wherein said one or more medications are packaged in a blister pack, said system comprising:
In a preferred embodiment, the system comprises also a casing suited to receive said blister pack, said casing comprising detection means suited to detect how many and/or which of said one or more medications are extracted from said blister pack.
Preferably, the system comprises a connection module interposed between the casing and the identification unit.
According to a preferred embodiment of the invention, the identification unit is part of said casing and communicates with the management unit wirelessly.
In a preferred embodiment, the connection module, the identification unit, the management unit and the wireless communication unit belong to a device which is suited to be used by the patient and to be connected to the casing that receives the blister pack.
Preferably, the device comprises an interface for the patient. More preferably, the interface comprises a display unit for the patient.
According to a preferred embodiment of the invention, the management unit and the wireless communication unit belong to a device, preferably a smartphone, more preferably a smartphone with a dedicated APP.
Preferably, the device communicates wirelessly with the identification unit that identifies the condition of the blister pack, preferably through a type of communication belonging to the group of types of communication including the following: BT communication, NFC communication, ZIGBEE communication, WIFI communication, UHF communication.
In a preferred embodiment of the invention, the identification unit is integrated in said blister pack.
Preferably, the service provider manages one or more interfaces for third-party operators.
The wireless communication unit and the service provider preferably communicate through a wide range communication network, for example one among the following networks: GSM, 3G, 4G, 5G, Sigfox, LoRa.
In a preferred embodiment, the management unit comprises storage means suited to store the patient's details.
According to a preferred embodiment of the invention, the blister pack comprises an identification system suited to generate an identification code for the type of medication received inside it.
According to a preferred embodiment of the invention, the casing comprises an identification system suited to generate an identification code suited to identify the type of blister pack or the type of medication that it can receive.
In a preferred embodiment, said identification system comprises a bar code or a RFID or a NFC.
Preferably, the identification unit comprises means for reading said identification code. More preferably, the reading means comprise a bar code reader, a RFID reader, a NFC reader.
According to a preferred embodiment of the invention, the management unit and/or the service provider is suited to determine when said medications have been extracted from the blister pack.
Preferably, said blister pack comprises one or more deformable cavities closed by one or more respective covers.
According to a second aspect of the present invention, the subject of the same is a method for monitoring and/or controlling the taking of one or more medications by a patient within a system of the type described above, comprising the following steps:
In a preferred embodiment, the method comprises a step during which information is communicated to the patient based on the result produced by the information processed by the management unit.
In a preferred embodiment, the method comprises a step during which data are transmitted to the management unit by the service provider through said wireless communication unit.
According to a preferred embodiment of the invention, the data transmitted by said service provider modify the information concerning the patient that are contained in said management unit.
In a preferred embodiment, the service provider interacts with one or more third-party operators.
According to a preferred embodiment of the invention, the method comprises a step during which the management unit and/or the service provider determine/s when said medications have been extracted from the blister pack.
Preferably, the method comprises a step during which the type of blister pack is identified univocally.
According to a third aspect of the present invention, the subject of the same is a casing suited to receive a blister pack for one or more medications, said casing comprising detection means suited to detect when one of said one or more medications is extracted from said blister pack, wherein the casing comprises an identification unit that identifies the condition of said blister pack, said identification unit being suited to identify how many and/or which of said one or more medications are extracted from said blister pack and wherein the casing communicates with another unit wirelessly.
According to a fourth aspect of the present invention, the subject of the same is a blister pack for one or more medications, comprising:
Preferably, said blister pack comprises one or more deformable cavities closed by one or more respective covers.
In a preferred embodiment, the blister pack is suited to determine when said medications have been extracted from the blister pack itself.
Further advantages, objects and characteristics, as well as further embodiments of the present invention, are defined in the claims and will be illustrated in the following description, with reference to the enclosed drawings; in the drawings, corresponding or equivalent characteristics and/or components of the present invention are identified by the same reference numbers. More specifically, in the drawings:
The present invention will be further clarified by means of the following detailed description of its preferred embodiments illustrated in the drawings. It should however be noted that the present invention is not limited to the particular embodiments described below and illustrated in the drawings; rather, it should be noted that the embodiments described below and illustrated in the drawings clarify some aspects of the present invention, the scope of which is defined in the claims. The present invention must therefore be considered as including all those variants and/or modifications that will be clear for the expert in the art.
The system 1 according to the present invention concerns the taking of one or more medications P by a patient, preferably medications in the form of pills P, said medications P being packaged in a blister pack 10.
As is known, correct medication-taking is a delicate and important aspect, for example in the treatment or prevention of diseases. In many cases, the patient is required to follow a precise schedule in the taking of the medication, in terms of both quantity and times.
In general terms, therefore, a patient's profile can be defined as the combination of information which includes the patient's identifier, for example name and surname or taxpayer identification number, the type of medication to be taken and the times when said medication must be taken.
The present description makes reference to medications packaged in blister packs.
As is known, a blister pack comprises one or more deformable cavities closed by one or more respective covers, the medication being received in said cavities. The cavity preferably comprises a sufficiently deformable material, such as plastic and aluminium, and the cover is preferably made of yielding paper, plastic or aluminium.
According to the above, in the context of the present invention a medication is generally intended to be a dose of a drug suited to be received in a blister pack, such as a pill, a dose of a drug available in the form of granules or of a powder, etc.
The medication P is extracted from the blister pack 10 by pressing against the deformable cavity with a finger: the pressure exerted by the finger on the medication P breaks the cover and allows the medication to be expelled.
With reference to
The identification unit 20 that identifies the condition of the blister pack 10 preferably represents a unit capable of determining how many and/or which medications P are extracted from the blister pack 10.
The management unit 30, which communicates with the identification unit 20, receives and processes the information transmitted by the identification unit 20 regarding how many and/or which medications P have been extracted from the blister pack 10.
In a preferred embodiment, the management unit 30 is also capable of determining when the medications P were extracted from the blister pack 10.
The wireless communication unit 40, which communicates with the management unit 30, transmits and/or receives wireless data to/from the service provider 50. More specifically, it transmits data concerning how many and/or which medications P were extracted from the blister pack 10.
In a preferred embodiment, the management unit 30 transmits also data concerning when the medications P were extracted from the blister pack 10.
The service provider 50 receives said wireless data from the wireless communication unit 40 and/or transmits wireless data to the wireless communication unit 40. More specifically, it receives data concerning how many and/or which medications P were extracted from the blister pack 10.
In a preferred embodiment, the service provider 50 receives also data concerning when the medications P were extracted from the blister pack 10.
In a further preferred embodiment, the service provider 50 itself determines when the medications P were extracted from the blister pack 10.
The wireless communication unit 40 and the service provider 50 preferably communicate through a wide range communication network, preferably a network of the type GSM, 3G, 4G, 5G, Sigfox, LoRa.
As explained in greater detail below, the service provider 50, which has said data available, is preferably capable of managing one or more interfaces for third-party operators, for example the operators indicated by U1, U2, U3 in
A third-party operator may be, for example, the pharmaceutical company U1, which produces a specific medication P and may be interested in knowing the quantity of said medication P that has been taken or the period when it was taken, and/or a doctor U2, who prescribed and/or follows the patient's therapy, or any other person U3 involved, for example a relative or the patient himself/herself.
Furthermore, one of said third-party operators U1, U2, U3 can interact with the management unit 30 through the service provider 50, for example for the purpose of controlling and/or setting the functions that are specific of the management unit 30.
In the drawing, component parts corresponding or equivalent to those indicated in the general diagram of
The system 101 comprises a set 12 defined by a casing 14 which receives the blister pack 10, a device 110 suited to be used by the patient and suited to receive the set 12, a service provider 50 and three interfaces for third-party operators U1, U2, U3.
The device 110 preferably incorporates the identification unit 20 that identifies the condition of the blister pack 10, the management unit 30 and the wireless communication unit 40 previously described.
The device 110, as shown in particular in
The casing 14, as shown in
In a preferred embodiment, the casing 14 comprises a first substrate 14a on which a layout, schematically illustrated and indicated by 16 in
In a preferred embodiment, the layout 16 is printed on both faces of the first substrate 14a.
The casing 14 comprises a second substrate 14b on which holes 17 are defined, said holes being preferably made in a position which is aligned with the position of the medications P in the blister pack 10 when the latter is received in the casing 14.
At the moment of extraction of a medication from the blister pack 10, the patient presses with a finger against the deformable cavity of the blister pack 10 and the pressure exerted by the finger on the medication P causes the breakage of the cover of the blister pack 10 itself and at the same time the breakage of one or more tracks of said layout 16 associated with the casing 14. This leads to a modification of the layout 16, which makes it possible to detect which medication P contained in the blister pack 10 has been extracted.
Preferably, the substrates 14a, 14b are made of paper, or cardboard, plastic, plastic film, aluminium, metallic foils, coupled materials, etc. The shapes and dimensions of the substrates can be different and suited to allow the blister pack 10 to be correctly received therein. The conductive ink can have different origins and colours, with a conductive base constituted by metal powder or alloys such as gold, silver, copper alloys and so on, or by other conductive elements dispersed in vehicles suitable for application with traditional or digital printing systems.
The printing techniques used for the application of the ink and the composition of the layout are preferably the following, direct or indirect: embossing, lithography, screen printing, intaglio printing such as, for example, letterpress printing, flexography, offset printing, serigraphy, rotogravure; of the hot or cold transfer type; of the digital type.
The ink can be preferably protected with paints, inks, decorative prints, lamination films, or coupled with materials such as paper, cardboard, plastic film, metallic foils.
Furthermore, preferably, the casing 14 can be directly coupled with the blister pack 10 or can be available in the existing package so that it can be coupled by the patient.
The casing 14 is preferably coupled with the blister pack 10 by means of glues, double-sided adhesives, adhesive labels.
In a preferred embodiment, the set 12 may comprise destruction systems suited to avoid any re-use of the casing 14 with other blister packs 10, for example a system that causes the irreversible breakage of the layout 16 so as to make it unusable if the blister pack 10 is extracted from the casing 14.
In order to allow the coupling between the casing 14 and the device 110 to be carried out, terminals 19 are preferably defined which are conveniently connected to the detection layout 16.
The device 110 in turn comprises a connection module 112 providing an interface with said terminals 19. The connection module 112 communicates with the identification unit 20.
The connection module 112 provides an interface with the terminals 19 of the casing 14 and is capable of reading the information present on the detection layout 16. In a preferred embodiment, the connection module 112 is capable of reading the tracks both on the upper side and on the underside in the case where both faces of the first substrate 16a are provided with a layout.
In a preferred embodiment, the connection module 112 comprises a connector with bayonet joint closing like an alligator's mouth.
The connection module 112 is thus capable of reading the condition of the blister pack 10 by means of the casing 14, meaning that it is capable of reading how many and/or which medications P were extracted from the blister pack 10.
In a preferred embodiment, the casing 14 comprises a unique identification code capable of identifying the type of blister pack 10 or the type of medication that it can receive.
The identification code preferably comprises a specific code printed on the layout.
In variant embodiments, the identification code can be of a different type, for example a bar code, an RFID code, an NFC code, etc.
In a different preferred embodiment, the blister pack 10 itself comprises a unique identification code which is suited to identify the type of medication contained therein.
The identification code preferably comprises a specific code such as, for example, a bar code, an RFID code, an NFC code, etc.
The device 110 will be preferably provided with reading means capable of detecting said identification code associated with the casing 14 or with the blister pack 10.
The reading means preferably comprise a bar code reader, an RFID reader, an NFC reader, etc.
The device 110 furthermore comprises an interface 114 for the patient. The interface 114 preferably comprises a display unit 116, or display, and a control button 118. In different embodiments, the interface 114 may comprise an acoustic alarm and/or a voice warning device.
According to the above, the management unit 30 of the device 110, which communicates with the identification unit 20, receives and processes the information transmitted by the identification unit 20 regarding how many and/or which medications P were extracted from the blister pack 10.
For example, as illustrated in
Furthermore, the device 110, and in particular the management unit 30, as explained above, is capable of determining also when the medications P were extracted from the blister pack 10, for example thanks to an internal clock.
Preferably, the management unit 30 comprises storage means suited to store one or more patient profiles.
The patient profile is capable of identifying the patient, for example through his/her name and surname or tax code, the type of medication to be taken and preferably the medicine taking times.
The management unit 30 provides for coordinating all the aspects of the operation of the device 110. The management unit 30 preferably provides for:
Furthermore, the management unit 30 is capable of receiving and managing the information transmitted by the service provider 50, such as, for example, the configuration parameters of the device 110, the updates of the user profile/profiles, etc. Such updates can be preferably requested by one or more of the third-party operators U1, U2, U3, for example in the case where the doctor U2 who follows the patient U2 deems it necessary to modify the administration times or the type of medication.
Such updates can also be preferably requested by the service provider 50 itself.
A possible operating mode of the system 1 according to the invention includes the following steps.
First of all, there is an initialization procedure for the device 110 through the registration of the patient, which is intended to associate a specific device 110 with a specific patient, for example by entering his/her name and surname or tax code. This data is advantageously sent to the service provider 50 and/or to one or more of the third-party operators U1, U2, U3, which therefore will be aware that a given device is associated with a specific patient.
At this point a patient profile is created, in which the type of medication to be taken by the patient is identified. This profile can be directly stored in the device 110 through the specific interface 114, for example by the patient himself/herself, or remotely by the service provider 50 and/or by one of the third-party operators U1, U2, U3. For example, the doctor U2 can define the profile of a patient by specifically indicating that the patient needs to take an antibiotic pill every 4 hours.
The patient then introduces the blister pack 10 containing the prescribed medication (for example, the antibiotic) inside the casing 14. Then, he/she proceeds to take the medication, extracting it from the blister pack 10 and thus from the set 14.
He/she successively introduces the set 14 inside the device 110, as shown for example in
The device 110 is able to immediately provide useful information to the patient, such as:
Furthermore, the device 110 can:
Other information can be displayed, for example a warning indicating that the battery is down or that there are connectivity problems towards the service provider.
Furthermore, to advantage, the device 110 transmits the information that the medication has been taken to the service provider 50 and/or to one of the third-party operators U1, U2, U3. In particular, the doctor U2 can monitor the correct progress of the treatment and, if necessary, decide to modify it, for example by changing the administration interval between two pills. The doctor U2 can remotely update the patient profile directly inside the device 110.
Other advantageous aspects related to the operation of the system 1 include the possibility to directly check whether the set being used, that is, the casing 14 and/or the blister pack 10, is exactly the one requested by the treatment.
Thanks to the presence of the identification codes associated with the casing and/or the blister pack, as described above, the device 110 is capable of double-checking whether the medication being taken corresponds to that prescribed for the treatment according to the patient profile stored inside it.
This may lead to immediate notification to the patient through the interface 114 and/or notification to the service provider 50 and/or to one of the third-party operators U1, U2, U3. For example, advantageously, the doctor and/or a relative can intervene immediately in order to remedy an anomalous situation.
In the drawing, component parts corresponding or equivalent to those indicated in the general diagram of
This embodiment of the system 201 differs from the system previously described in that all the modules 20, 30 and 40, 112 previously incorporated in the device 110 are now integrated in two separate devices 210 and 230 which communicate with each other. From the functional point of view, the two devices 210 and 230 as a whole serve the same functions as the device 110, in accordance with the description provided above.
The system 201 thus preferably comprises a set 12 defined by a casing 14 which receives the blister pack 10, a first device 210 suited to receive the set 12, a second device 230, a service provider 50 and three interfaces for third-party operators U1, U2, U3.
The first device 210 preferably incorporates the identification unit 20 that identifies the condition of the blister pack 10 and the connection module 212 for interfacing with the set 12. The second device 230 preferably incorporates the management unit 30 and the wireless communication unit 40 previously described.
The first and the second device 210, 230 preferably communicate with each other through a wireless connection. The two devices 210, 230 preferably communicate through a technology of the known type, for example a BT, NFC, ZIGBEE, WIFI, UHF technology, etc.
In a preferred embodiment, the second device 230 comprises a cellular phone, preferably a smart phone, provided with a specific program installed therein, for example an App suited to serve the same functions as the management unit 30 and the wireless communication unit 40.
The display of the cellular device preferably serves as an interface towards the user.
In the drawing, component parts corresponding or equivalent to those indicated in the general diagram of
Such embodiment of the system 301 differs from the systems previously described in that the identification unit 20 that identifies the condition of the blister pack 10, the management unit 30 and the wireless communication unit 40 are distributed differently.
The system 301 preferably comprises a set 312 defined by a casing 14 which receives the blister packs 10 and in which the identification unit 20 is integrated. In this case the connection module is omitted, since the identification unit 20 is integrated in the casing 14.
The system 301 preferably comprises also a second device 230, a service provider 50 and three interfaces for third-party operators U1, U2, U3.
The second device 230 is a device carried out as described above with reference to the embodiment of
The identification unit 20 of the set 312 and the second device 230 preferably communicate with each other through a wireless connection. Preferably, communication takes place through a technology of the known type, for example a BT, NFC, ZIGBEE, WIFI, UHF technology, etc.
In a preferred embodiment, as already explained above, the second device 230 comprises a cellular phone, preferably a smart phone, provided with a specific program installed therein, for example an App suited to serve the same functions as the management unit 30 and the wireless communication unit 40.
The display of the cellular device preferably serves as an interface towards the user.
In the drawing, component parts corresponding or equivalent to those indicated in the general diagram of
Such embodiment of the system 401 differs from the previous embodiment described with reference to
The system 401 thus preferably comprises a blister pack 410 that integrates the identification unit 20, a second device 230, a service provider 50 and three interfaces for third-party operators U1, U2, U3.
The second device 230 is a device carried out as described above with reference to the embodiments of
The identification unit 20 that identifies the blister pack 410 and the second device 230 preferably communicate with each other through a wireless connection. Preferably, communication takes place through a technology of the known type, for example a BT, NFC, ZIGBEE, WIFI, UHF technology, etc.
In a preferred embodiment, as already explained above, the second device 230 comprises a cellular phone, preferably a smart phone, provided with a specific program installed therein, for example an App suited to serve the same functions as the management unit 30 and the wireless communication unit 40.
The display of the cellular device preferably serves as an interface towards the user.
As far as the blister pack 410 is concerned, it will be provided with suitable electronics installed thereon and suited to detect any breakage of the covers of the cavities when the medication is extracted. A suitable energy source will be provided in order to supply power to said electronics, such as, for example, batteries or photovoltaic cells.
In a preferred embodiment, the blister pack 410 comprises a unique identification code suited to identify the type of medication contained in its cavities.
The identification code preferably comprises a specific code such as, for example, a bar code, an RFID code, an NFC code, etc.
The operating modes of the systems according to
The extraction of a medication from the blister pack and the assumed taking of the same are detected by the system, which is capable of providing information to the patient himself/herself or to a third party involved. Furthermore, the system makes it possible to intervene even remotely in order to check the correct progress of the treatment and to make any adjustments.
It has thus been shown, by means of the description provided, that the system carried out according to the present invention allows the set objects to be achieved. More specifically, the monitoring and/or control system according to the present invention makes it possible to monitor and, if necessary, adjust the taking of medications by patients.
Even if the present invention has been illustrated above by means of the detailed description of some embodiments represented in the drawings, the present invention is not limited to the embodiments described above and represented in the drawings; on the contrary, further variants of the embodiments described above fall within the scope of the present invention, which is defined in the claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 102018000001807 | Jan 2018 | IT | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2018/060676 | 12/28/2018 | WO | 00 |
