WO2012013723A1 - Pharmaceutical product dispenser - Google Patents

Pharmaceutical product dispenser Download PDF

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Publication number
WO2012013723A1
WO2012013723A1 PCT/EP2011/062940 EP2011062940W WO2012013723A1 WO 2012013723 A1 WO2012013723 A1 WO 2012013723A1 EP 2011062940 W EP2011062940 W EP 2011062940W WO 2012013723 A1 WO2012013723 A1 WO 2012013723A1
Authority
WO
WIPO (PCT)
Prior art keywords
dispenser
dispensing
pharmaceutical
communication
container body
Prior art date
Application number
PCT/EP2011/062940
Other languages
French (fr)
Inventor
Guy De Sévaux
Original Assignee
Dsm Ip Assets B.V.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dsm Ip Assets B.V. filed Critical Dsm Ip Assets B.V.
Publication of WO2012013723A1 publication Critical patent/WO2012013723A1/en

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00Containers or packages with special means for dispensing contents
    • B65D83/04Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills
    • B65D83/0409Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills the dispensing means being adapted for delivering one article, or a single dose, upon each actuation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0481Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/30Compliance analysis for taking medication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0418Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with electronic history memory
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0436Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system resulting from removing a drug from, or opening, a container
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2583/00Containers or packages with special means for dispensing contents
    • B65D2583/04For dispensing annular, disc-shaped or spherical or like small articles or tablets
    • B65D2583/0472For dispensing annular, disc-shaped or spherical or like small articles or tablets characterised by the dispensing action
    • B65D2583/0477For dispensing annular, disc-shaped or spherical or like small articles or tablets characterised by the dispensing action the container is maintained in the same position during the dispensing of several successive articles or doses
    • B65D2583/0481One reciprocating action, e.g. to or from

Definitions

  • the invention relates to a pharmaceutical dispenser, especially a pocket dispenser, comprising a container consisting of a container body shell and a container cover shell which are attached to each other, wherein the container body shell incorporates an insertable and/or exchangeable cartridge member containing a supply of pharmaceutical products to be dispensed.
  • the invention further relates to a system comprising a dispenser and an external database.
  • Solid pharmaceutical preparations or pharmaceutical products are generally prescribed by a physician to the patient; however some pharmaceutical preparations/products can be obtained without prescription (so-called "over- the- counter- medication”) .
  • over- the- counter- medication Whether the medication is prescribed by a physician or obtained free over-the-counter, best results are generally obtained when the medication is taken at regular intervals so that the effective ingredient in the medication is replenished at regular and precise intervals and/or at fixed moments in time, for example before going to sleep.
  • Increased adherence will generate medical savings already by the fact that less medication needs to be prescribed as for example a treatment will be shorter. Savings will additionally come from the fact that . not- consumed medication must be disposed of in a sensible way, giving rise to additional costs. The not-consumed medication can pose a health risk when it is not brought back to the pharmacy or is not disposed of in another sensible way. Additionally the presence of the medication in some system can generate immunity against the active ingredient in the medication.
  • Increased adherence can thus increase the patient's well-being and health, decrease the negative side effects, decrease the risk of immunity, increase the effectiveness of the therapy, decrease secondary medical costs such as emergency services, decrease the amount of medication that needs to be treated as waste because it is not consumed, it overall decreases the costs of the health care system in a country.
  • dispensers for dispensing discrete items as for instance pharmaceuticals are known. Also a lot of dispensers equipped with electronic components which are suitable for detecting and controlling the dispensing of pharmaceuticals contained in the dispenser and which are able to store the respective data and to communicate with remote information systems are known.
  • a pharmaceutical dispenser especially a pocket dispenser, comprising a clamshell container comprising a container body shell and a container cover shell which are swivel-mounted attached to each other, wherein the container body shell incorporates an insertable and exchangeable cartridge member containing a supply of pharmaceutical products and incorporates an, especially insertable and exchangeable, dispensing member having a pharmaceutical product receiving chamber and cooperating with and/or being a part of a dispenser slider, which dispensing member is arranged to bring by lateral movement of the dispenser slider alternately a receiving opening of the product receiving chamber in receiving communication with a discharge opening of the cartridge member and a discharge opening of the product receiving chamber in dispensing communication with a dispensing opening provided in the container body shell.
  • the object is also achieved by a system comprising a dispenser according to one ore more of the claims 1-14 and an external database .
  • the invention provides a dispenser in the form of a claitipshell container which looks discreet and personal and does not look medical. It is further easy and convenient to handle because it is only necessary to open the shell, move the slider and shake the box to move a pharmaceutical from the cartridge member into the product receiving chamber of the receiving member and to operate the dispenser slider for dispensing a dose of pharmaceutical product.
  • This dispenser is easy to use for patients, pharmacies and throughout the whole logistic channel. Due to the insertable and exchangeable cartridge member containing a supply of pharmaceutical products it is easy to provide packages containing such cartrigde members and to control the use of the correct medication. Until opened to use the cartridge member of the dispenser and the package or packaging is tamper proof closed.
  • the dispenser also comprises a preferably insertable and/or exchangeable dispensing member having a pharmaceutical product receiving chamber cooperating with a dispenser slider it is cost-efficient to produce and adaptable to differently sized pharmaceutical products.
  • the discharge opening of the product receiving chamber can be brought into dispensing communication with a receiving opening of a dispensing channel or of a passage, which dispensing channel or passage is formed in the container body shell.
  • the dispensing channel or the passage is arranged and designed to be in a delivery communication with a receptacle and/or the dispensing opening provided in the container body shell.
  • the pharmaceutical dispenser comprises a container body shell which comprises at least one chamber or a volume containing electronic components .
  • the container body shell comprises a dispensing detecting component for detecting and/or monitoring the dispensing of each pharmaceutical product, which is dispensed.
  • the insertable cartridge member comprises a pharmaceutical product containing chamber of a height to accommodate only one layer of pharmaceutical products.
  • the pharmaceutical dispenser is further characterized by a pharmaceutical product receiving chamber wherein the pharmaceutical product receiving chamber of the respectively used dispensing member is adapted to the size and the amount of the pharmaceutical product to be received and to be dispensed by the product receiving chamber during a dispensing cycle.
  • Such a dispenser is flexible with regard to pill sizes and/or dosage.
  • the dispenser is modular built.
  • the insertable and/or exchangeable cartridge member and/or the dispensing member are module components of a modular concept which are formed to be inserted into the container body shell.
  • the electronics may be module components of the modulor concept.
  • the invention further proposes a pharmaceutical dispenser, wherein the dispenser slider and/or the dispensing member is moved against the force of a spring from a position where the discharge opening of the product receiving chamber is in dispensing communication with the dispensing opening to a position where the receiving opening of the product receiving chamber is in receiving communication with the discharge opening of the cartridge member.
  • the dispenser slider may be manually operated.
  • the cartridge member is equipped with guiding elements separating and guiding one pharmaceutical product contained in the cartridge member towards the discharge opening of the cartridge member.
  • the dispenser according to the invention may further comprise an electronic circuit and/or an energy supply for monitoring, controlling, indicating and/or communication, especially data communication .
  • the dispenser may be equipped with electronic components and/or an electronic circuit, which comprises:
  • a sensor or a dispensing detecting component configured to detect a dispensing event of a single dose of the medication/pharmaceutical product from the dispenser
  • a memory that stores information associated with the dispensing event ;
  • transceiver that, preferably wirelessly, transmits the information associated with the dispensing event to an external device.
  • the dispenser may comprise an electronic circuit, which is configured to receive information and/or commands from an external source or an external device.
  • the dispenser may be equipped with a user interface comprising a screen which may be interactive and/or a buzzer and/or a user-operable switch and/or a light.
  • the discharge opening of the dispensing cartridge member may be closed by a removable sealing foil and the closure of the clamshell container may be of a child resistant construction so that the pharmaceutical dispenser is tight and child resistant .
  • a "pharmaceutical product” is understood to be a synonym for all kinds of medication and pills offered in a non liquid form or a rigid form or an application form to be stored within the dispensing cartridge member which pharmaceutical product may be for instance a tablet, a capsule or of another pharmaceutical form.
  • the proposed pharmaceuticals dispensing device or dispenser is aimed at a population of, especially chronically, ill people who regularly have to take a dose of medication.
  • the pharmaceutical dispenser provided with the respective electronic elements and/or components is able to measure the medication actually taken from the dispenser, to feed back the information to the patient and to send this data on demand to a central information system and/or an external database.
  • a system/database comprising and being based on the pharmaceutical dispenser according to the invention enables the medical infrastructure (doctors, caretakers, pharmacists) to follow up on the status of the patient.
  • Such a system may communicate with the pharmaceutical dispenser throughout the period that the medication has to be taken.
  • the pharmaceutical dispenser according to the present invention is different in the sense that it offers a discreet and easy-to-use way for patients to take their medication. All indications that this device is a medical device are hidden inside .
  • the pharmaceutical dispenser may also be a modular device which uses a holder or clamshell container consisting of a container body shell and a container cover shell which are swivel-mounted attached to each other and comprising an insertable and/or exchangeable cartridge member containing a supply of pharmaceutical products, a dispensing mechanism consisting of an, especially insertable and/or exchangeable, dispensing member having a pharmaceutical product receiving chamber cooperating with a dispenser slider arranged to bring alternately by lateral movement of the dispenser slider a receiving opening of the product receiving chamber in receiving communication with a discharge opening of the cartridge member and a discharge opening of the product receiving chamber in dispensing communication with a receiving opening of a dispensing channel formed in the container body shell and being in delivery communication with a dispensing opening provided in the container body shell.
  • the pharmaceutical dispenser according to the present invention may be constructed and designed as a communication and measuring device, which additionally, if desired, comprises the communication and measuring means as separate interchangeable parts.
  • the pharmaceutical dispenser may due to an adequate equipment with electric and/or electronic components and means read the authentication information provided on the cartridge member and communicate with a central authentication server to verify whether the medication which is entered in the respective cartridge member inserted into the pharmaceutical dispenser is an authentic medication and especially no counterfeit.
  • using the dispenser can be time controlled, and this control can be executed from the system.
  • the dispenser can only be opened between preset time intervals.
  • the dispenser can only be opened after a message from the system has been received.
  • the dispenser can only be used 24 hours after the previous usage.
  • FIG. 1 a perspective view of a pharmaceutical dispenser according to a first embodiment of the invention in its closed position,.
  • Fig. 2 a perspective view of the pharmaceutical dispenser according to Fig. 1 in its open position
  • Fig. 3 a section view of a container body shell according to the embodiment of Fig. 1 and 2,
  • Fig. 4 a schematic view of the embodiment of a pharmaceutical dispenser according to Fig. 1-3,
  • Fig. 5 a schematic perspective view of a first embodiment of a cartridge member of a pharmaceutical dispenser according to the invention
  • FIG. 6 some schematic views of positions of the pharmaceutical dispenser according Fig. 1-4 during its use, a second embodiment of a pharmaceutical dispenser according to the invention, a perspective view of the cartridge member, push buttons of the child resistant closure and a spring and switch member of the second embodiment of a pharmaceutical dispenser according to the invention, a perspective view of an insertion part and a dispensing member and a dispenser slider of the second embodiment according Fig. 7 and 8,
  • Fig. 10 a perspective view of the dispensing member and the dispensing slider of the second embodiment
  • Fig. 11 a plan view onto the container body shell of the second embodiment with the dispensing member/dispenser slider separated therefrom
  • Fig. 12 diagrammatically a block diagram of the electronic monitoring and communication means of a dispenser
  • Fig. 13 diagrammatically the/a dispenser in association with a docketing station for the exchange of monitoring and communication data
  • Fig. 14 diagrammatically a block diagram of the docking station of Fig. 13, and
  • Fig. 15 diagrammatically a therapy compliance monitoring and communication system.
  • Figur 1 shows a pharmaceutical product dispenser, in short a pharmaceutical dispenser 1, in its closed position with the container cover shell 2 of a clamshell container 3 resting on the container body shell 4.
  • the container cover shell 2 and the container body shell 4 are swivel-mounted attached to each other by means of a hinge 5, so that the clamshell container 3 can be opened in its open position as shown in Figure 2.
  • the container cover shell 2 is provided with a child resistant closure 6 and a holder 7 for holding an insert 8.
  • On the inner side of the container cover shell 2 a pharmacy label 9 is attached.
  • the container body shell 4 incorporates an insertable and/or exchangeable cartridge member 10 containing a supply of pharmaceutical products 11.
  • the container body shell 4 further comprises a dispensing member 12, which preferably, if desired, is also of an insertable and exchangeable kind and which has a pharmaceutical product receiving chamber 13 cooperating with a dispenser slider 14 connected thereto.
  • the cartridge member 10 is of a transparent or translucent material, so that it is possible to observe the pharmaceutical products 11 contained therein.
  • the pharmaceutical product receiving chamber 13 is covered by a window 15, which is closed with a transparent or translucent material and which is formed in the dispenser slider 14, so that it is possible to identify whether a pharmaceutical product 11 has reached the pharmaceutical product receiving chamber 13 by looking at the window 15.
  • the receiving chamber 13 may be an opening in the cover wall 14a of the dispenser slider 14.
  • the pharmaceutical product receiving chamber 13 has a receiving opening 16 and a discharge opening 17.
  • the pharmaceutical product receiving chamber 13 is alternately movable between a position where the receiving opening 16 of the product receiving chamber 13 is in receiving communication with a - and the only - discharge opening 18 of the cartridge member 10 and a position where the discharge opening 17 of the product receiving chamber 13 is in dispensing communication with a dispensing opening 25 provided in the cover elements 23 and/or the container body shell 4.
  • this dispensing communication is realized by a dispensing channel 20 formed and constituted in the container body shell 4 and provided with a receiving opening 19.
  • the dispensing channel 20 is built by sidewalls of opposing chambers 21, 22 containing electronics, electronic components and/or an energy source like a battery, by the bottom of the container body shell 4 and a cover element 23.
  • the dispensing channel 20 is in delivery communication with a receptacle 24 and said dispensing opening 25 provided in the cover element 23 and/or the container body shell 4.
  • a light emitting element 26 arranged and in the other of the opposing chambers 22 is crossing through the dispensing channel 20 a light receiving and detecting element 27 arranged, wherein the elements 26, 27 constitute a dispensing detecting component which detects dispensing of a pharmaceutical product 11 delivered through the dispensing channel 20.
  • One of the chambers 21, 22 may also contain a buzzer (not shown) .
  • the cartridge member 10 comprises and/or constitutes a pharmaceutical product containing chamber 28 of such a height that it can contain only one layer of pharmaceutical products 11.
  • the pharmaceutical product receiving chamber 13 is adapted to the size and the amount of the pharmaceutical product 11 which will and shall be received by the pharmaceutical product receiving chamber 13. Normally it is of a dimension to hold only one piece of pharmaceutical product 11. But it can also be of a dimension which allows to hold two or more pieces of pharmaceutical products.
  • insertable and exchangeable cartridge member 10 and/or the, if desired, insertable and exchangeable dispensing member 12 may be module components of a modular concept which are formed to be inserted into the container body shell 4.
  • the dispenser slider 14 is moved against the force of a spring 29 which is attached to the dispensing member 12.
  • the cartridge member 10 and more specifically the pharmaceutical product 11 containing chamber 28 is equipped with guiding elements, i.e. a funnel, (not shown) separating and guiding one pharmaceutical product 11 contained in the cartridge member 10 towards the discharge opening 18 of the cartridge member 10.
  • guiding elements i.e. a funnel, (not shown) separating and guiding one pharmaceutical product 11 contained in the cartridge member 10 towards the discharge opening 18 of the cartridge member 10.
  • the container body shell 4 comprises an inner wall 30 for receiving, holding and supporting the sidewall section of the cartridge member 10 which comprises the discharge opening 18.
  • the dispenser slider 14 is or can be provided with a finger print recognition 31 and the cover element 23 is or can be provided with a display unit or screen 32. Further, the cover element 23 can be equipped with a software operating button 33.
  • the cartridge member 10 comprises a seal or seal foil 34 which closes the discharge opening 18 tightly and which is part of a cartridge closure liner 35.
  • the cartridge member 10 further comprises an authentication mark.
  • the dispensing member 12 can be equipped with an authentication reader, an authentication button and a lock and unlock activator.
  • the pharmaceutical dispenser 1, especially the chamber 21, houses a dispensing reader on output, the electronics, an antenna, batteries, a battery charging device and a LED blinking light. All this may be provided on one or two printed circuit boards (PCB) , which are inserted into the container body shell 4.
  • PCB printed circuit boards
  • All parts of the clamshell container 3 with the exception the electronics may be produced from plastic materials injection moulding.
  • a patient receives a pharmaceutical dispenser 1 and a number of prescribed cartridge members 10.
  • the pharmacist enters the patient pharmacy label 9 on the inside of the container cover shell 2 and attaches the insert 8 to the attachment element or holder 7.
  • the cartridge member 10 is a disposable element. It may consist of at least one transparent wall 36 which enables the user to recognize the tablets or pharmaceutical products and to see them move whilst dispensing, a non-transparent bottom 37 which may be made of desiccant material and which may hold a label which can be printed with medical information, a tamper-evident cartridge seal 34 and an authentication mark.
  • the tamper-evident seal 34 is taken off the cartridge member 10.
  • the cartridge member 10 is then placed into the container body shell 4 and clicks to its position.
  • a cartridge door closes the cartridge member 10 discharge opening 18 tightly by pressing a non-ferrous metal closure liner 35 against the elastomer lined discharge opening 18 of the cartridge member 10. In this way, the medication is well protected against environmental influences, e.g. humidity.
  • Placing the cartridge member 10 in the container body shell 4 also may press an authentication button, which starts an electronic authentication system of the pharmaceutical dispenser 1.
  • the pharmaceutical dispenser 1 reads the authentication mark and sends the read information to a central server for approval.
  • the electronics unlock the dispenser mechanism of the dispensing member 12 through the lock and unlock activator and the pharmaceutical dispenser 1 is ready to use.
  • the patient has to take a tablet or pharmaceutical product 11 each time the regimen prescribes him/her to do so.
  • the system comprising the pharmaceutical dispenser 1 may set alarms to remind the patient to take medication and/or to send data to the system. These reminders may be stored in the components of the system or in the pharmaceutical dispenser 1 itself.
  • Reminders may be communicated visually via the screen 32 or the blinking light (LED) or audibly via a buzzer.
  • the patient opens the pharmaceutical dispenser 1 by pushing the child resistant closure or lock 6 and folding the container cover shell 2 and the container body shell 4 in their open position as shown by Figure 2. Then, the user shakes the pharmaceutical dispenser 1 a little to make sure a pharmaceutical product 11 coming from the pharmaceutical product containing chamber 28 of the cartridge member 10 is ready to be dispensed. He can see this through the transparent side wall 36 of the cartridge member 10. Then, he moves the dispensing slider 14 from the left side to the right side as indicated by the arrow 38 as shown in Fig. 6, which will start the electronics and open the cartridge door. When having reached the position as shown in Fig.
  • the receiving opening 16 of the pharmaceutical product receiving chamber 13 has come in receiving communication with the discharge opening 18 of the cartridge member 10 and a pharmaceutical product 11 falls into the pharmaceutical product receiving chamber 13 of the dispensing member 12. This can be seen through the transparent window 15 of the dispensing slider 14.
  • the patient now moves the dispensing slider 14 back in the direction indicated by arrow 39, which will transport the receiving chamber 13 and the pharmaceutical product 11 contained therein towards the dispensing channel 20 and the receptacle 24.
  • the pharmaceutical product 11 is dispensed through the dispensing opening 25.
  • the electronic components 26, 27 measure the movement of the pharmaceutical product 11, and store the event's time and date in the memory of the pharmaceutical dispenser 1. After a preset time the electronics switch off automatically.
  • the pharmaceutical dispenser 1 only dispenses one pharmaceutical product 11 per push of the dispensing slider 14. Pharmaceutical products 11 or tablets which are pushed back in the dispensing member 12 are recorded by the electronics. In this event, no pharmaceutical product 11 enters the dispensing channel 20 although the slider 14 has been pushed or moved.
  • the patient may have to authenticate himself with a finger print authentication system.
  • the patient puts his finger on the fingerprint recognition 31 which will unlock the activator.
  • the pharmaceutical dispenser 1 may be time- locked.
  • a patient can only dispense a pharmaceutical product 11 when the activator is unlocked. Unlocking takes place automatically during a programmed times pan entered in the back end system. This time span can depend on many variables, such as the regimen, the time the last pill was taken, the maximum amount of pills to be taken per day.
  • the patient can ask the doctor to unlock the pharmaceutical dispenser 1, and the doctor may send per data exchange an unlock message to the pharmaceutical dispenser 1.
  • the pharmaceutical dispenser 1 After each event, or on preset times, the pharmaceutical dispenser 1 needs to communicate with a system of which it is a part.
  • the pharmaceutical dispenser 1 can hold different communication principles to set up communication with other parts of the system.
  • the pharmaceutical dispenser 1 holds an NFC (Near Field Communication) interface in the electronics and an antenna that communicate with a dedicated program (midlet) on an NFC-enabled mobile phone. This phone sends event data to the system or other parts or embodiments of the system and can receive data back to unlock the dispensing device 1.
  • NFC Near Field Communication
  • the pharmaceutical dispenser 1 holds a Bluetooth interface and antenna that works in the same way as the NFC interface.
  • the pharmaceutical dispenser 1 holds all the GSM ⁇ Global System for Mobile Communications) elements needed to make it function as a mobile data device.
  • the pharmaceutical dispenser 1 is autonomous and can communicate directly with the system, without a mobile phone .
  • the energy source, especially the battery, of the pharmaceutical dispenser 1 can be either normal batteries, or rechargeable . In the latter case, recharging may be wireless, via the NFC or Bluetooth antenna; or wired with an additional charger. In another configuration a solar charger is applied.
  • the pharmaceutical dispenser 1 has a user interface that helps the user to take his medication, understand the proper functioning of the pharmaceutical dispenser 1, and helps communicating with the system.
  • this interface is limited to a blinking multi-coloured light (e.g., LED) that offers different messages.
  • a buzzer is added which gives alarm sounds.
  • a screen 32 is presented which indicates the different functions with text and logos .
  • buttons which activate the different signal and communication functions. For example, when pressing the button 33 the software will start operation, or the device LED will turn green when it's time to take a pill, and red when such is not the case. Alternatively buttons may activate the screen 32 and help the user to navigate a menu .
  • cartridge member can also be realized in the form of a blister package.
  • the cartridge member 10 may be provided with an RFID-Chip for identification .
  • the battery may be permanently switched “on”. It is also possible, that the battery will be switched to “on” when the cartridge is inserted into the container body shell 4 and that it is switched to “off” when the cartridge is removed from the container body shell 4. Communication may also take place via the bluetooth ANT protocol, which is a low voltage communication protocol.
  • the holder 7 may be provided with a magnifier .
  • An alternative embodiment of a pharmaceutical dispenser 1, which is represented by Fig. 7, comprises instead of a wall 30 and opposing chambers 20, 21 a section which comprises an insertion part 40 and the dispensing chamber 12, both housed and covered by a cover 41 and side wall sections and bottom sections of the container body shell 4.
  • the insertion part 40 is provided with the necessary electronics and data communication devices and power sources, which are preferably arranged at a Printed Circuit Board (PCB) .
  • PCB Printed Circuit Board
  • This embodiment comprises a child resistant closure 6, which has two push buttons 42a, 42b which are opposing each other arranged in the side wall of the container body shell 4 and which are in closing and releasable connection with corresponding protrusions or recesses built in the container cover shell 2.
  • These push buttons 42a, 42b comprise resilient parts so that they may be pushed in a direction to the inside of the pharmaceutical dispenser 1 thereby releasing corresponding closure parts provided in the container cover shell 2.
  • This pharmaceutical dispenser 1 comprises a discharge opening 18 provided at the cartridge member 10, wherein the discharge opening 18 is surrounded by an elastomer liner 35, 43, which is built from a soft material which is formed during injection moulding of this side wall of the cartridge member 10.
  • This side wall may be constructed as a closure part inserted into an injection moulded box like cartridge member 10.
  • the closure part may comprise additional section, which are equipped with a soft liner or a soft material.
  • the outer rim portion 45 of the closure part 44 may be made of a soft material for providing a tight seal to the cartridge member and to the neighbouring dispensing member 12 when the cartridge has been inserted into the container body shell 4.
  • the discharge opening 18 is covered by a closure member 46 of the dispensing member 12, which outer rim portion 47 is of a form, which matches the form of the elastomer liner 43 surrounding the discharge opening 18, wherein the outer rim portion 47 is in the closure position in a closing contact with the elastomer liner 43.
  • the dispensing member 12 has to be moved by a first step of a dispensing cycle a little bit in the direction as indicated by an arrow 48 to remove the outer rim portion 47 and elastomer liner 43 from each other.
  • the dispensing member 12 has to be slided in a direction perpendicular to the first direction, which direction is indicated by an arrow 49.
  • This second movement is stopped when the receiving opening 16, is in a position in front of the discharge opening 18, which is indicated by an abutment of a rib 50 extending from the dispensing member 12 against a rim part 51 of an opening 52 provided within the cover 41.
  • These two steps of movement have to be conducted against the force of a spring 53.
  • the spring 53 has an arc-like form and is with its one end attached to the insertion part 40 and with its opposing end attached to the dispensing member 12.
  • the spring 43 is arranged in such a way that as well the movement in the directions as indicated by arrow 48 as the movement as indicated by arrow 49 is conducted against the force of the spring 41, which therefore has to be compressed when moving the dispensing member 12 in this way.
  • one spring 53 it would also be possible to have an arrangement of two springs, each being attached to the insertion part 40 and the dispensing member 12, respectively and each providing a spring force directed against one of the direction as indicated by arrows 48, 49.
  • Fig. 9 represents the position of the dispenser slider 14 after the first step of a dispensing cycle comprising the movement in direction of the arrow 48 has been completed. On the other hand this is the same position when the dispensing member 12 has been pushed back against the direction as indicated by the arrow 49.
  • the pharmaceutical product receiving chamber 13 comprises a bottom wall 54, a top wall 55, which constitutes a window of the dispenser slider 14 or the dispensing member 12, and two opposing side walls 56, 57. All these parts are made of a transparent or translucent material.
  • the pharmaceutical product receiving chamber 13 comprises no front wall, because this part of the receiving chamber 13 constitutes the receiving opening 16.
  • the back side wall of the pharmaceutical product receiving chamber 13 is constituted by a wall member 58 extending from the insertion part 40 as can be seen from Fig. 11.
  • the wall member 58 prevents a pharmaceutical product to fall out of the pharmaceutical product receiving chamber 13 when being dispensed through the discharge opening 18 of the cartridge member 10.
  • the insertion part 40 furthermore comprises two opposing guiding walls 59, 60 also extending from the surface of the insertion part and constituting a passage for a pharmaceutical product leaving the pharmaceutical product receiving chamber 13 in a position of the dispensing member 12, where the discharge opening 17 of the pharmaceutical product receiving chamber 13 is in dispensing communication with the receptacle 24 and/or the dispensing opening 25 of the pharmaceutical dispenser 1.
  • the two guiding walls 59, 60 providing a passage constitute a special form of a dispensing channel 20.
  • the insertion part 40 comprises two slots 61, 62 wherein the dispensing member 12 or dispenser slider 14 is guided with a foot-like protrusion 63, 64, respectively, which foot-like protrusions 63, 64 are inserting in a respective slot 61, 62.
  • Another foot-like protrusion 65 is also arranged at a rim portion of the dispenser slider 14 and is used to switch on two switches arranged on a Printed Circuit Board (PCB) , which is arranged backside the insertion part 40, wherein the switches switch the electronics "on” and “off”.
  • the foot-like protrusion 65 is inserted in and guided by a further slot 66. In the starting and end position of the dispensing slider 14 and the dispensing member 12, which is shown in Fig. 7, each of the foot-like protrusions 63, 64, 65 rest and are blocked by an extension provided in the respective slot 61, 62 and 66.
  • the pharmaceutical product receiving chamber 13 and/or the dispenser member 12 and the insertion part 40 which by position of the wall member 58 altogether define the size of the pharmaceutical product receiving chamber 13, are exchanged and interchanged but all parts are nevertheless dimensioned to fit with the size of the pharmaceutical dispenser 1, i.e. the container body shell 4. In this sense the parts are module components of a modular system.
  • the insertion part 40 further comprises a spring and switch member 69, which is slidable arranged in a slot of the insertion part 40 and which is provided with a resilient arm 70.
  • a spring and switch member 69 which is slidable arranged in a slot of the insertion part 40 and which is provided with a resilient arm 70.
  • the pharmaceutical products 11 and/or the dispensing event detecting means constituted by a light emitting element 26 and a light receiving and detecting element 27 or others are situated at such a distance to each other that during the whole movement of the dispensing member 12/dispenser slider 14 during a dispensing cycle the product receiving chamber 13 remains permanently between the two opposing detecting means 26, 27. Due to such an arrangement it is possible to detect via the detecting means 26, 27 the event that a pharmaceutical product 11 falls into the pharmaceutical product receiving chamber 13, the event that a pharmaceutical product 11 is still contained in the pharmaceutical product receiving chamber 13 and the event, that a pharmaceutical product 11 has been dispensed from the pharmaceutical product receiving chamber 13.
  • Fig. 12 shows a block diagram of an electronic circuit 2500 for use in a pharmaceutical dispenser 1 according to the invention and for use in monitoring and controlling administration of medications and for communication.
  • the electronic circuit 2500 includes a processor 2502, which may, for example, be an 8-bit microcontroller, such as a P89LPC936, available from NXP Semiconductors Netherlands B. V. Of course, it will be understood that other processors or microcontrollers may also be used in the electronic circuit 2500.
  • the processor 2502 may be clocked by an external clock or crystal 2503.
  • the processor 2502 may include a memory 2504, for storing programmed instructions for the processor 2502 and/or data used by the electronic circuit 2500.
  • the memory 2504 may include one or more external memory devices (not shown) .
  • the memory 2504 may include non-volatile memory, such as flash memory, EEPROM memory, or static memory, and/or volatile memory, such as DRAM.
  • the electronic circuit 2500 is powered by a battery 2506, which may have its electrical characteristics adapted to the needs of the electronic circuit 2500 by a power regulator 2508.
  • the battery 2506 may be a conventional replaceable battery, or a rechargeable battery, which may be recharged, for example, when the device is connected to a docking station (see below) .
  • the power regulator 2508 may also include the ability to detect the status of the battery 2506, and provide the status information to the processor 2502. In some embodiments, an additional battery measuring device ⁇ not shown) may be used to measure the status of the battery 2506.
  • the processor 2502 communicates with a first transceiver 2510, which communicates wirelessly with other electronic devices via a first antenna 2512.
  • the first transceiver 2510 uses radio frequency (RF) -based communication, such as Near Field Communication (NFC) or other wireless communication technologies suitable for short-range and/or low-power wireless communication, such as other RFID technologies, Bluetooth, or ZigBee. Where power considerations permit longer range communications, other wireless communications technologies, such as Wi-Fi, WiMAX, or various cellular technologies may be employed.
  • RF radio frequency
  • the processor 2502 may further include a display driver 2516, to operate the display 2514.
  • the display driver 2516 may be implemented at least in part as driver software.
  • the display driver 2516 may be a separate device (not shown) , rather than being included in the processor 2502.
  • an optical detector 26, 27, 2518 such as a laser detector, an LED and detector, an infrared LED and detector, or other opto-electronic detection device, is used to determine when a solid preparation, such as a pill, has been dispensed by the device.
  • a signal from the optical detector 2518 is provided to the processor 2502 for evaluation.
  • signals from each of these the optical detectors are provided to the processor 2502.
  • the electronic circuit 2500 may also include numerous control switches for adjusting the settings of the processor 2502 and/or of the electronic circuit 2500.
  • a first switch 2520 can be used to activate or deactivate the electronic monitoring and communication.
  • a second switch 2522 can be used to detect tampering with the dispenser device by detection its removal from the container.
  • Third and fourth switches 2524 and 2526 may be used, for example, for setting the time in hours (third switch 2524) and minutes (fourth switch 2526) .
  • a fifth switch 2528 may be used to select use of an audible alarm, such as a buzzer 2530, which may be sounded when, for example, a patient has forgotten to dispense a medication at the time that he is supposed to take it, or when temperature and/or humidity sensors indicate that the medication is being improperly stored. It will be understood that, depending on the user interface needs of the embodiment, the control switches may be assigned to other functions.
  • the electronic circuit 2500 may also optionally include alarm devices, such as the buzzer 2530 and/or a vibration device 2532. These alarm devices may be activated by the processor 2502 separately or in unison, to alert a user to a variety of conditions. In some embodiments, the buzzer 2530 may be controlled to produce a variety of different sounds to alert a user to various conditions.
  • alarm devices such as the buzzer 2530 and/or a vibration device 2532.
  • one sound may be used to warn the user that he should take a dose of a medication
  • another sound may be used to warn the user that he is attempting to dispense additional medication before it is safe to take another dose
  • a further sound may be used to warn the user that the medication in the container is running low
  • another sound may be used to indicate that the battery is low
  • still another sound may be used to indicate to the user that temperature and/or humidity sensors are indicating that the medication is not being properly stored.
  • the buzzer 2530 may be a small speaker, capable of producing sounds including buzzing noises, speech, musical tones, or other sounds, depending on the message to be conveyed to the user.
  • the timing of the sounds or vibrations produced by the buzzer 2530 and/or vibration device 2532 may be controlled by the processor 2502 to convey particular meanings or warnings.
  • the processor 2502 may be programmed to use the buzzer 2530 to produce a warning sound at a predetermined time after the solid preparation should have been dispensed. For example, a short beep could be generated every minute during one hour following the time when the solid preparation should have been dispensed.
  • the processor 2502 may be programmed to cease such warnings when the solid preparation has been dispensed through the dispenser.
  • the processor 2502 may be programmed to use the vibration device 2532 in a similar manner. For example, the vibration device 2532 may be switched on for one second at the time that the solid preparation should be dispensed. This may be repeated, for example, sixty minutes later, if the solid preparation is not dispensed.
  • the electronic circuit 2500 may optionally be connected to a blocking mechanism 2534.
  • the blocking mechanism 2534 prevents the dispenser 1 from dispensing a solid preparation. This can be achieved, for example, by sending electrical signals to a motor or solenoid to move a stopper notch between a locked and an unlocked position, as described above.
  • the blocking mechanism 2534 may be used, for example, to prevent a user from dispensing a further dose of a medication during a time period over which a further dose is not needed or could be dangerous, or from dispensing medication which may have been damage by exposure to temperatures or humidity levels outside of an acceptable range.
  • the electronic circuit 2500 may further include additional sensors, such as an optional humidity sensor 2536 and/or an optional temperature sensor 2538, positioned in such a way that they are able to detect the humidity and/or temperature of the pills, capsules, or other solid preparations stored in the dispenser 1 device.
  • the humidity sensor 2536 may, for example, be a capacitive humidity sensor, a resistive humidity sensor, a thermal conductivity humidity sensor, or other suitably small, commercially available electronic humidity detection device.
  • the temperature sensor 2538 may be a thermistor or other resistance temperature detector, or any other suitably small, commercially available electronic temperature detector. These sensors should be positioned so that they measure the temperature and/or humidity of the pills, capsules, or other solid preparations stored in the container, bottle, or dispenser .
  • the electronic circuit 2500 may be configured to fit within a portion of the dispenser mechanism, as shown in earlier figures above. Individual components of the electronic circuit 2500 may be built into other portions of the dispenser, depending on their function.
  • the humidity detector 2536 and temperature detector 2538 may be positioned so that they measure the humidity and/or temperature in the locations where pharmaceutical products 11 such as pills, capsules, or other solid preparations are stored .
  • the dispenser mechanism may include an identity detection device 31.
  • an identity detection device may be connected to the electronic circuit 2500 to permit the user of the dispenser to be identified.
  • An example of such an identity detection device is a fingerprint reader and identifier 31.
  • the processor 2502 may be programmed to accept signals from such a fingerprint reader (not shown) , and to activate the dispenser only when the fingerprint read by the fingerprint reader matches a stored fingerprint.
  • the stored fingerprint may be stored in the memory 2504, or in a memory associated with the fingerprint reader (not shown) . Since fingerprints are unique, the fingerprint of the authorized user of the device may be stored, so that only the authorized user of the device is able to activate the dispenser and to dispense a solid preparation.
  • Other identity detection devices could also be used, including other (preferably small/portable) biometric devices, or security measures such as requiring the user to enter a combination or a personal identification number (PIN) .
  • an identity function may be implemented for the dispenser.
  • This identity function makes it possible that only an authorized or intended user, such as the patient or a caregiver, can activate the dispenser. Using this feature, the solid preparation could not be dispensed, for example, by a child who finds the device. Additionally, the identity function may reduce the risk of taking the wrong medication, for example if there are several such dispensers being used by different people in a single household.
  • the electronic circuit 2500 may be connected to an RFID reader (not shown ⁇ in the dispenser 1.
  • Some medication containers or cartridge members 10 may be equipped with RFID chips (not shown ⁇ that can contain information on the medication in the container.
  • RFID chips may be placed on or built into the container when the container is manufactured, or at a later time, such as when a pharmacist provides the container containing medication to the patient.
  • the RFID chip in such a container may be a standard MIFARE RFID chip, or any other type of RFID chip or tag.
  • a drug manufacturer, physician, and/or pharmacist may store information on the RFID chip.
  • the RFID chip may include the date and time of packing a medication in the container, the content of the container, the drug type and number of pills, the expiration date of the medication, a unique identification number, patient medication intake times, length of the course of treatment, pharmacist license number, prescribing physician license number, proper storage temperature and humidity ranges, and/or other information pertaining to the solid preparation contained in the container .
  • the RFID reader may be used to read this information from the RFID chip attached to the container when the dispenser is attached to the container.
  • the information can then optionally be stared in the memory 2504, and used by the processor 2502 for a variety of purposes.
  • the dispenser includes a display, such as the display 2514, the information read by the RFID reader may be displayed. This can reduce the risk of taking the wrong medication or medication that has passed its "use by" date. The risk of taking the wrong medication may be especially pronounced when a patient needs to take two or more types of medication.
  • an RFID reader in the dispenser is used with an RFID chip on the container, the patient is able to read on the display which of his medications is contained in the container.
  • the processor 2502 may use the information read from an RFID chip on the container for purposes such as displaying the drug contained in the container, determining when the container is almost empty (based on pill count) , automatically programming the times that the solid preparation should be dispensed or accessed so that the processor 2502 may generate alarms at the proper times, producing a warning when a medication has expired or has been stored at an unacceptable temperature and/or humidity level, preventing a user from dispensing or accessing the solid preparation at the wrong times, after it has expired, after a course of treatment has been completed, if improper temperature and/or humidity conditions may have affected the medication, and other uses for such information.
  • the RFID reader may also store information back into the RFID chip on the container. This means that compliance or adherence information may be available in the container chip when it is returned to the pharmacist, for example for a refill.
  • a docking station 2602 is used for electronic data communication and electronic data transfer between the dispenser and a computer (not shown) or other communication device (not shown) . Additionally, in some embodiments, the docking station 2602 may be used to recharge a rechargeable battery in the dispenser.
  • the docking station 2602 may include a wired connection 2604, such as a USB connection or other wired connection for transferring data between the docking station 2602 and a computer or other communication device.
  • the docking station 2602 may include a wireless communication device (not shown) to allow the docking station 2602 to communicate via a wireless connection, such as through a cellular network, a wireless wide area network, or a wireless local area network.
  • the docking station may be powered using an AC mains adapter 2606, or through power received over the wired connection 2604.
  • the docking station 2602 is also eguipped with an electronic reader-writer device (described below) , for reading and writing data from the dispenser.
  • an electronic reader-writer device described below
  • the dispenser is able to communicate directly with a wide area network or cellular network, or where the communication is handled by a portable reader, such as a mobile phone equipped with an NFC reader, the docking station 2602 may not be needed for the dispenser to communicate its data.
  • Fig. 14 shows a block diagram of an electronic reader-writer device 2700 suitable for use in the docking station 2602 of Fig. 26.
  • the reader-writer device 2700 includes a second transceiver 2702 with a second antenna 2704 for communicating with the first transceiver 2510 in the dispenser, as shown in Fig. 12.
  • the dispenser may preferably use a low power, short range communication technology, such as Near Field Communication (NFC) , Bluetooth, or ZigBee.
  • NFC Near Field Communication
  • Bluetooth Bluetooth
  • ZigBee ZigBee
  • Other communications technologies suitable for longer range wireless communications may also be used, such as WiFi or other wireless local area network (WLAN) technology.
  • WLAN wireless local area network
  • the communication technology used by the reader- writer should be compatible with the communication technology used by the dispenser.
  • a physical electrical connection between the dispenser and the docking station could be used, assuming that the dispenser includes an appropriate interface.
  • the dispenser has a USB interface, it may be possible to connect it to the docking station ⁇ or directly to a USB-equipped external computer) using the USB interface.
  • a physical interface such as a USB interface, may also be useful for charging a rechargeable battery in the dispenser.
  • the reader-writer device 2700 also may include a wired connection interface 2706.
  • the wired connection interface 2706 may be, for example, a USB interface through which the reader- writer device connects the docking station to an external computer system.
  • Other types of wired connections such as a serial connection or a wired Ethernet connection could also be used.
  • the reader-writer device 2700 may be powered from an AC adapter (not shown) through a voltage regulator 2708. Alternatively power may be received from other sources, such as through the wired connection interface 2706.
  • the external computer can transfer the data to a remote computer via a wide area network, such as the Internet.
  • the dispenser may also receive data via a wide area network through an external computer (and, possibly a docking station) .
  • programming or instructions for the electronic circuit 2500 of the dispenser may be sent from a computer at a remote location, and communicated to the dispenser via the Internet or other wide area network.
  • the remote computer may, for example, be accessible by a physician, pharmacist, or other medical professional who is overseeing the therapy compliance or adherence of the patient who is using the dispenser.
  • the dispenser may be able to connect to the Internet and/or the remote computer system without using an external computer or docking station to establish the connection. It will also be understood that in some embodiments / a mobile device, such as an NFC-equipped mobile telephone may be used to communicate between the remote computer and the dispenser.
  • a mobile device such as an NFC-equipped mobile telephone may be used to communicate between the remote computer and the dispenser.
  • the system 2800 of Fig. 15 includes one or more dispensers 2802, which include the electronic circuitry 2500 as shown in Fig. 12.
  • these dispensers include NFC communication circuitry, which allows them to transfer data between a dispenser 2802 and an NFC-equipped mobile telephone 2804.
  • the NFC-equipped telephone 2804 can wirelessly communicate via a wide area network 2806, such as a cellular communication network or the Internet with a remote database 2808, which collects and stores information from the dispenser (s) 2802.
  • the remote database 2808 can be accessed (through the wide area network 2806 or a different wide area network) by a remote computer 2810, which may also remotely send instructions to the dispenser (s) 2802 through the wide area network 2806 and the mobile telephone 2804.
  • the communication path may be somewhat different, depending on the technology used.
  • the dispenser may use a docking station ⁇ not shown) connected to a computer (not shown ⁇ to communicate with the remote database 2808 and/or the remote computer 2810.
  • the dispenser may be able to directly connect to the wide area network, and communicate with the remote database 2808 and/or the remote computer 2810 without using an NFC-equipped mobile telephone or a docking station.
  • the therapy compliance or adherence monitoring and communication means provided can be mobile.
  • the dispenser 2802 is arranged for monitoring the therapy compliance or adherence of a patient, and for remotely allowing or disabling the dispensing of a solid preparation, to help ensure therapy compliance or adherence.
  • Wired and/or wireless communications can be used to report therapy compliance or adherence to the remote computer 2810, which may be used by a physician, pharmacist, or other medical caregivers to monitor compliance or adherence. Additionally, administration of therapy may be controlled or adjusted from the remote computer 2810, depending on the therapy compliance or adherence reporting received.
  • other communication technologies may be used in the remote surveillance and control of therapy compliance or adherence, including mobile platforms, such as the mobile telephone 2804, and the like.
  • the dispenser 2802 When a container with a solid preparation is issued by a pharmacist, the dispenser 2802 according to an embodiment of the invention is put in place on the container, such that solid preparations may be taken from the container by pushing a button on the dispenser 2802.
  • the dispenser 2802 has a built-in clock/calendar so that when the button is operated and a solid preparation, such as a pill or tablet is dispensed, the date and time of this event are stored in a memory in the dispenser 2802. Similarly, the times of other events, such as recording of temperature and or humidity readings can be stored.
  • the dispenser 2602 may optionally be programmed so that the solid preparation may only be dispensed at pre-programmed times, depending on the medication prescribed, and the instructions of the physician and/or pharmacist.
  • this option of programming the dispenser provides the opportunity to register and regulate a combination therapy, whereby more than one type of medication must be taken, as will be described in greater detail below.
  • the date and time stamp at which a dose was dispensed, and/or other information, such as temperature and/or humidity data are transferred over the wide area network, which may be a mobile telephone network, such as GSM or GPRS, to the patient's record in the remote database 2808.
  • this transfer may be accomplished by reading the data from the dispenser using a Near Field Communication (NFC ⁇ mobile phone 2804, or by using another gateway for conversion of data from NFC or Bluetooth devices into SMS and GPRS data. It will be understood that other communication options, as described above are also possible.
  • other data collected by the dispenser may also be transferred along with the compliance or adherence data. For example, data concerning the temperature and humidity of the stored medication may be transferred.
  • the data may indicate whether the pills, capsules, or other solid preparations are being stored in appropriate conditions. This information may be used to send the patient and/or the pharmacist or physician a warning if the medication is being stored at an inappropriate temperature or humidity. This data could also be used, for example, to dynamically adjust the expiration date of a medication, depending on its storage conditions, or to prevent a patient from taking medications which could become dangerous if stored for a period of time in an inappropriate manner. Other information, such as the battery status may also be transferred. This data may, for example, be used to warn the patient or pharmacist if a non- rechargeable battery in the dispenser device will need to be replaced.
  • the patient record in the database 2808 contains various kinds of patient information, including the therapy compliance records for the patient received from one or more dispensers.
  • This information can be securely accessed by physicians, pharmacists, or other authorized medical caregivers from a remote computer 2810 over a wide area network, such as the Internet.
  • the compliance or adherence data may be correlated and analyzed in the remote database 2808 or on the remote computer 2810, and if mal- compliance/adherence or non-compliance/adherence are detected, the patient can be warned, for example via an SMS service or the like.
  • a call centre, pharmacist, and/or care organization may receive an instruction to call the patient to discuss his mal- or noncompliance/adherence .
  • a dispenser according to an embodiment of the invention can also communicate with another dispenser, either directly, through a docking station, or through a network.
  • An advantage of such a dispenser is that it is possible to regulate an order in which two or more medications are taken.
  • a combination of drugs may be prescribed, which need to be taken in a strict order and according to a strict time schedule.
  • the prescription schedule can specify that a first medication should be taken first, followed within one hour by a second medication. If the patient forgets that he has already taken the required dosage of the first medication, he may try to "correct” this by taking another dose of the first medication.
  • Such noncompliance/adherence can have serious effects on the health of the patient and on the effectiveness of the treatment.
  • a first dispenser for a container containing the first medication can block further dispensing of the first medication until it receives a communication indicating that a second dispenser for a container containing the second medication has dispensed a dose of the second medication.
  • a new dose of the first medication can only be taken after the required dose of the second medication has been taken.
  • the time for taking the second medication can be set by the second dispenser receiving a communication indicating that the first medication has been dispensed by the first dispenser, causing the second dispenser to set a buzzer or other alarm feature to provide a warning one hour later that the second medication should be taken.
  • communication between the dispensers can be achieved directly between the dispensers, or via an indirect method.
  • the dispensers may communicate through a base station, or through a wireless network.
  • the dispensers could communicate indirectly through a database, such as the remote database 2808 shown in Fig. 15, or through another computer or communication device that receives and sends communications to dispensers in accordance with various embodiments of the invention.
  • the dispenser according to the invention can be used for dispensing various sizes and shapes of solid preparations. This feature makes it possible to use the dispenser several times for different solid preparations.
  • the dispenser according to the invention can be used in combination with many types of cartridge members 10, providing a reservoir for the solid preparations 11 to be dispensed through the dispenser 1.
  • a cartridge member 10 has such dimensions that the dispenser 1 can be carried by a patient .
  • the detector can be a laser detector.
  • a dispenser system can comprise a dispenser 1 including an electronic circuit and an energy supply for monitoring, controlling and/or communication.
  • the energy supply includes a battery and the electronic circuit includes a microcontroller, wherein the electronic circuit preferably includes a first transceiver.
  • Such an embodiment may further comprise an alarm signal generator, wherein the alarm signal generator can be selectable to generate an audible signal by means of a buzzer.
  • the alarm signal generator can include a vibrator.
  • a dispenser system can further comprise an electromechanical blocking mechanism.
  • the dispenser system can further include an LCD display for transferring messages.
  • the system can comprise a docking station. In this case, the docking station has a communication link for the exchange of data with an auxiliary data communication device.
  • the docking station is arranged for data communication with an auxiliary device in the form of a mobile platform, such as a mobile phone.
  • the system comprising an electronic circuit and a first transceiver may comprise a docking station which includes a second transceiver, wherein the first and second transceiver use Near Field Communication technology.
  • the docking station can also include an USB interface, wherein the communication link includes an USB- connection.
  • a cartridge member 10 and a clamshell container 3 may cooperate as a dispenser device.
  • a method of monitoring a patient's medication compliance or adherence can comprise
  • dispenser system which dispenser system tracks at least one type of patient medicine compliance/adherence data, said dispenser system being connected to a pharmaceutical dispenser 1,
  • the pharmaceutical dispenser 1 may be equipped with an absorber function obtained by an absorber component.

Abstract

The invention discloses a pharmaceutical product dispenser (1), especially a pocket dispenser, comprising a clamshell container (3) having a container body shell (4) which incorporates an insertable and exchangeable cartridge member (10) containing a supply of pharmaceutical products (11) and incorporates dispensing member (12) having a pharmaceutical product receiving chamber (13) and cooperating with and/or being a part of a dispenser slider (14), which dispensing member (12) is arranged to bring by lateral movement of the dispenser slider (14) alternatively a receiving opening (16) of the product receiving chamber (13) in receiving communication with a discharge opening (18) of the cartridge member (10) and a discharge opening (17) of the product receiving chamber (13) in dispensing communication with a dispensing opening (25) provided in the container body shell (4). The dispenser also includes electronic components for monotoring the dispensing of the products.

Description

Pharmaceutical Product Dispenser
The invention relates to a pharmaceutical dispenser, especially a pocket dispenser, comprising a container consisting of a container body shell and a container cover shell which are attached to each other, wherein the container body shell incorporates an insertable and/or exchangeable cartridge member containing a supply of pharmaceutical products to be dispensed.
The invention further relates to a system comprising a dispenser and an external database.
Solid pharmaceutical preparations or pharmaceutical products are generally prescribed by a physician to the patient; however some pharmaceutical preparations/products can be obtained without prescription (so-called "over- the- counter- medication") . Whether the medication is prescribed by a physician or obtained free over-the-counter, best results are generally obtained when the medication is taken at regular intervals so that the effective ingredient in the medication is replenished at regular and precise intervals and/or at fixed moments in time, for example before going to sleep.
Daily or otherwise regular usage is not only important in the normal use of medication so as to have an as regular dosage pattern as possible, but it is even more important in clinical trials. Before any drug is allowed to be prescribed by a physician, the drugs must be registered at local agencies, such as the FDA (Food and Drug Administration) in the USA and the EMA (European Medicines Agency) in Europe. Only after registration the drugs may be prescribed and put on the market and sold. To pass the registration procedure lots of data regarding the drug need to be collected and supplied to the authorities. Part of these data is the result of clinical trials. In several phases of the clinical trials, patients are administered a certain dose of the drug. The effects of the drug on the patient are carefully followed, so as to be able not only to determine the effect of the drug but also possible side effects. For the correct determination of the side effects it is important that the patient strictly follows the prescribed medication regime, or in other words that he complies with the regime. When he deviates from the regime he is considered not to be compliant.
With "compliance" or "adherence" is here and hereinafter meant the behaviour of a patient to follow a prescribed medication regime in a therapy.
Increased adherence will generate medical savings already by the fact that less medication needs to be prescribed as for example a treatment will be shorter. Savings will additionally come from the fact that . not- consumed medication must be disposed of in a sensible way, giving rise to additional costs. The not-consumed medication can pose a health risk when it is not brought back to the pharmacy or is not disposed of in another sensible way. Additionally the presence of the medication in some system can generate immunity against the active ingredient in the medication.
Increased adherence can thus increase the patient's well-being and health, decrease the negative side effects, decrease the risk of immunity, increase the effectiveness of the therapy, decrease secondary medical costs such as emergency services, decrease the amount of medication that needs to be treated as waste because it is not consumed, it overall decreases the costs of the health care system in a country.
For the reasons described above, either separately or combined, it is desirable to have means available to aid for example a patient, researcher, physician and/or pharmacist and other to increase the rate of compliance or adherence for taking medication. Possibly it not only increases the rate, but also increases the convenience, that is "the ease" with which compliance or adherence can be reached. In addition to the mentioned persons, it could also be advantageous for family and/ or friends and/ or other care- takers around the patient who are involved in some way in the medical treatment of a patient. Therefore it is an object of the invention to provide means which could increase the rate of patient's compliance (adherence) .
Further a number of manually operable dispensers for dispensing discrete items as for instance pharmaceuticals are known. Also a lot of dispensers equipped with electronic components which are suitable for detecting and controlling the dispensing of pharmaceuticals contained in the dispenser and which are able to store the respective data and to communicate with remote information systems are known.
Nevertheless there is still a need and a demand for dispensers which have an attractive and pleasant form, are easy to handle and which are easy and cost-efficient to produce.
It is therefore an object of the invention to provide an improved dispenser that is convenient to handle and cost- efficient to produce.
This object is achieved by a pharmaceutical dispenser, especially a pocket dispenser, comprising a clamshell container comprising a container body shell and a container cover shell which are swivel-mounted attached to each other, wherein the container body shell incorporates an insertable and exchangeable cartridge member containing a supply of pharmaceutical products and incorporates an, especially insertable and exchangeable, dispensing member having a pharmaceutical product receiving chamber and cooperating with and/or being a part of a dispenser slider, which dispensing member is arranged to bring by lateral movement of the dispenser slider alternately a receiving opening of the product receiving chamber in receiving communication with a discharge opening of the cartridge member and a discharge opening of the product receiving chamber in dispensing communication with a dispensing opening provided in the container body shell.
Further advantageous and appropriate embodiments are subject of the dependent claims.
The object is also achieved by a system comprising a dispenser according to one ore more of the claims 1-14 and an external database .
The invention provides a dispenser in the form of a claitipshell container which looks discreet and personal and does not look medical. It is further easy and convenient to handle because it is only necessary to open the shell, move the slider and shake the box to move a pharmaceutical from the cartridge member into the product receiving chamber of the receiving member and to operate the dispenser slider for dispensing a dose of pharmaceutical product. This dispenser is easy to use for patients, pharmacies and throughout the whole logistic channel. Due to the insertable and exchangeable cartridge member containing a supply of pharmaceutical products it is easy to provide packages containing such cartrigde members and to control the use of the correct medication. Until opened to use the cartridge member of the dispenser and the package or packaging is tamper proof closed. Due to that fact that the dispenser also comprises a preferably insertable and/or exchangeable dispensing member having a pharmaceutical product receiving chamber cooperating with a dispenser slider it is cost-efficient to produce and adaptable to differently sized pharmaceutical products. In one advantageous arrangement of the pharmaceutical dispenser according to the invention, the discharge opening of the product receiving chamber can be brought into dispensing communication with a receiving opening of a dispensing channel or of a passage, which dispensing channel or passage is formed in the container body shell.
In such an embodiment of the invention it is further purposeful, that the dispensing channel or the passage is arranged and designed to be in a delivery communication with a receptacle and/or the dispensing opening provided in the container body shell.
In another aspect of the invention the pharmaceutical dispenser comprises a container body shell which comprises at least one chamber or a volume containing electronic components .
Especially in connection with this embodiment it is further possible that the container body shell comprises a dispensing detecting component for detecting and/or monitoring the dispensing of each pharmaceutical product, which is dispensed.
Due to these electronic components it is possible to select such kind of electronic components which can measure the patients compliance or adherence and which can communicate with remote information systems. This enables high level authenticity measures when using the dispenser according the present invention.
To make it possible to have a dispenser of a small size and to design it as a pocket dispenser it is a further aspect of the invention that the insertable cartridge member comprises a pharmaceutical product containing chamber of a height to accommodate only one layer of pharmaceutical products. To make the dispenser adaptable to different pill sizes and to different dosages to be dispensed the pharmaceutical dispenser is further characterized by a pharmaceutical product receiving chamber wherein the pharmaceutical product receiving chamber of the respectively used dispensing member is adapted to the size and the amount of the pharmaceutical product to be received and to be dispensed by the product receiving chamber during a dispensing cycle. Such a dispenser is flexible with regard to pill sizes and/or dosage.
Further it is possible that the dispenser is modular built. For this purpose, according to another aspect of the invention, the insertable and/or exchangeable cartridge member and/or the dispensing member are module components of a modular concept which are formed to be inserted into the container body shell. Also the electronics may be module components of the modulor concept.
For easy dispensing of a pharmaceutical product the invention further proposes a pharmaceutical dispenser, wherein the dispenser slider and/or the dispensing member is moved against the force of a spring from a position where the discharge opening of the product receiving chamber is in dispensing communication with the dispensing opening to a position where the receiving opening of the product receiving chamber is in receiving communication with the discharge opening of the cartridge member. The dispenser slider may be manually operated.
For easy removal of a pharmaceutical product out of the cartridge member into the product receiving chamber of the receiving member the cartridge member is equipped with guiding elements separating and guiding one pharmaceutical product contained in the cartridge member towards the discharge opening of the cartridge member.
The dispenser according to the invention may further comprise an electronic circuit and/or an energy supply for monitoring, controlling, indicating and/or communication, especially data communication .
Further, the dispenser may be equipped with electronic components and/or an electronic circuit, which comprises:
a sensor or a dispensing detecting component, configured to detect a dispensing event of a single dose of the medication/pharmaceutical product from the dispenser;
a memory that stores information associated with the dispensing event ;
and a transceiver that, preferably wirelessly, transmits the information associated with the dispensing event to an external device.
Finally, the dispenser may comprise an electronic circuit, which is configured to receive information and/or commands from an external source or an external device.
The dispenser may be equipped with a user interface comprising a screen which may be interactive and/or a buzzer and/or a user-operable switch and/or a light.
The discharge opening of the dispensing cartridge member may be closed by a removable sealing foil and the closure of the clamshell container may be of a child resistant construction so that the pharmaceutical dispenser is tight and child resistant .
A "pharmaceutical product" is understood to be a synonym for all kinds of medication and pills offered in a non liquid form or a rigid form or an application form to be stored within the dispensing cartridge member which pharmaceutical product may be for instance a tablet, a capsule or of another pharmaceutical form.
The proposed pharmaceuticals dispensing device or dispenser is aimed at a population of, especially chronically, ill people who regularly have to take a dose of medication. The pharmaceutical dispenser provided with the respective electronic elements and/or components is able to measure the medication actually taken from the dispenser, to feed back the information to the patient and to send this data on demand to a central information system and/or an external database. Such a system/database comprising and being based on the pharmaceutical dispenser according to the invention enables the medical infrastructure (doctors, caretakers, pharmacists) to follow up on the status of the patient. Such a system may communicate with the pharmaceutical dispenser throughout the period that the medication has to be taken.
The pharmaceutical dispenser according to the present invention is different in the sense that it offers a discreet and easy-to-use way for patients to take their medication. All indications that this device is a medical device are hidden inside .
The pharmaceutical dispenser may also be a modular device which uses a holder or clamshell container consisting of a container body shell and a container cover shell which are swivel-mounted attached to each other and comprising an insertable and/or exchangeable cartridge member containing a supply of pharmaceutical products, a dispensing mechanism consisting of an, especially insertable and/or exchangeable, dispensing member having a pharmaceutical product receiving chamber cooperating with a dispenser slider arranged to bring alternately by lateral movement of the dispenser slider a receiving opening of the product receiving chamber in receiving communication with a discharge opening of the cartridge member and a discharge opening of the product receiving chamber in dispensing communication with a receiving opening of a dispensing channel formed in the container body shell and being in delivery communication with a dispensing opening provided in the container body shell.
With the help of electronic elements and/or electronic components the pharmaceutical dispenser according to the present invention may be constructed and designed as a communication and measuring device, which additionally, if desired, comprises the communication and measuring means as separate interchangeable parts.
Next to this, the pharmaceutical dispenser may due to an adequate equipment with electric and/or electronic components and means read the authentication information provided on the cartridge member and communicate with a central authentication server to verify whether the medication which is entered in the respective cartridge member inserted into the pharmaceutical dispenser is an authentic medication and especially no counterfeit.
As an option, using the dispenser can be time controlled, and this control can be executed from the system. For example, the dispenser can only be opened between preset time intervals. Or the dispenser can only be opened after a message from the system has been received. Or the dispenser can only be used 24 hours after the previous usage.
The invention is explained in more detail with the help of an exemplary embodiment as shown by Figures 1-15. The illustrations show in Fig. 1 a perspective view of a pharmaceutical dispenser according to a first embodiment of the invention in its closed position,.
Fig. 2 a perspective view of the pharmaceutical dispenser according to Fig. 1 in its open position,
Fig. 3 a section view of a container body shell according to the embodiment of Fig. 1 and 2,
Fig. 4 a schematic view of the embodiment of a pharmaceutical dispenser according to Fig. 1-3,
Fig. 5 a schematic perspective view of a first embodiment of a cartridge member of a pharmaceutical dispenser according to the invention,
Fig. 6 some schematic views of positions of the pharmaceutical dispenser according Fig. 1-4 during its use, a second embodiment of a pharmaceutical dispenser according to the invention, a perspective view of the cartridge member, push buttons of the child resistant closure and a spring and switch member of the second embodiment of a pharmaceutical dispenser according to the invention, a perspective view of an insertion part and a dispensing member and a dispenser slider of the second embodiment according Fig. 7 and 8,
Fig. 10 a perspective view of the dispensing member and the dispensing slider of the second embodiment, Fig. 11 a plan view onto the container body shell of the second embodiment with the dispensing member/dispenser slider separated therefrom
Fig. 12 diagrammatically a block diagram of the electronic monitoring and communication means of a dispenser,
Fig. 13 diagrammatically the/a dispenser in association with a docketing station for the exchange of monitoring and communication data,
Fig. 14 diagrammatically a block diagram of the docking station of Fig. 13, and
Fig. 15 diagrammatically a therapy compliance monitoring and communication system.
Figur 1 shows a pharmaceutical product dispenser, in short a pharmaceutical dispenser 1, in its closed position with the container cover shell 2 of a clamshell container 3 resting on the container body shell 4. The container cover shell 2 and the container body shell 4 are swivel-mounted attached to each other by means of a hinge 5, so that the clamshell container 3 can be opened in its open position as shown in Figure 2. The container cover shell 2 is provided with a child resistant closure 6 and a holder 7 for holding an insert 8. On the inner side of the container cover shell 2 a pharmacy label 9 is attached. The container body shell 4 incorporates an insertable and/or exchangeable cartridge member 10 containing a supply of pharmaceutical products 11. The container body shell 4 further comprises a dispensing member 12, which preferably, if desired, is also of an insertable and exchangeable kind and which has a pharmaceutical product receiving chamber 13 cooperating with a dispenser slider 14 connected thereto. The cartridge member 10 is of a transparent or translucent material, so that it is possible to observe the pharmaceutical products 11 contained therein. Also the pharmaceutical product receiving chamber 13 is covered by a window 15, which is closed with a transparent or translucent material and which is formed in the dispenser slider 14, so that it is possible to identify whether a pharmaceutical product 11 has reached the pharmaceutical product receiving chamber 13 by looking at the window 15. Alternatively, it is also possible to make the receiving chamber 13 of a transparent or translucent material, wherein the receiving chamber 13 comprises at least a bottom wall, a top wall, and two opposing side walls. In this case, the window 15 may be an opening in the cover wall 14a of the dispenser slider 14.
The pharmaceutical product receiving chamber 13 has a receiving opening 16 and a discharge opening 17. By manually operated lateral movement (it is also possible to have this movement motorized) of the dispenser slider 14 the pharmaceutical product receiving chamber 13 is alternately movable between a position where the receiving opening 16 of the product receiving chamber 13 is in receiving communication with a - and the only - discharge opening 18 of the cartridge member 10 and a position where the discharge opening 17 of the product receiving chamber 13 is in dispensing communication with a dispensing opening 25 provided in the cover elements 23 and/or the container body shell 4. In the embodiment according to Fig. 1-4 and 6 this dispensing communication is realized by a dispensing channel 20 formed and constituted in the container body shell 4 and provided with a receiving opening 19. The dispensing channel 20 is built by sidewalls of opposing chambers 21, 22 containing electronics, electronic components and/or an energy source like a battery, by the bottom of the container body shell 4 and a cover element 23. The dispensing channel 20 is in delivery communication with a receptacle 24 and said dispensing opening 25 provided in the cover element 23 and/or the container body shell 4.
Within one of the opposing chambers 21 is a light emitting element 26 arranged and in the other of the opposing chambers 22 is crossing through the dispensing channel 20 a light receiving and detecting element 27 arranged, wherein the elements 26, 27 constitute a dispensing detecting component which detects dispensing of a pharmaceutical product 11 delivered through the dispensing channel 20. One of the chambers 21, 22 may also contain a buzzer (not shown) .
The cartridge member 10 comprises and/or constitutes a pharmaceutical product containing chamber 28 of such a height that it can contain only one layer of pharmaceutical products 11.
The pharmaceutical product receiving chamber 13 is adapted to the size and the amount of the pharmaceutical product 11 which will and shall be received by the pharmaceutical product receiving chamber 13. Normally it is of a dimension to hold only one piece of pharmaceutical product 11. But it can also be of a dimension which allows to hold two or more pieces of pharmaceutical products.
The insertable and exchangeable cartridge member 10 and/or the, if desired, insertable and exchangeable dispensing member 12 may be module components of a modular concept which are formed to be inserted into the container body shell 4.
During its lateral movement from the position where the receiving opening 16 of the product receiving chamber 13 is in receiving communication with the discharge opening IB of the cartridge member 10 to a position where the discharge opening 17 of the product receiving chamber 13 is in dispensing communication with the dispensing opening 25 or, according to the embodiment of Fig. 1-4 and 6 where the receiving chamber 13 is in dispensing communication with the receiving opening 19 of the dispensing channel 20, the dispenser slider 14 is moved against the force of a spring 29 which is attached to the dispensing member 12.
The cartridge member 10 and more specifically the pharmaceutical product 11 containing chamber 28 is equipped with guiding elements, i.e. a funnel, (not shown) separating and guiding one pharmaceutical product 11 contained in the cartridge member 10 towards the discharge opening 18 of the cartridge member 10.
Further, the container body shell 4 comprises an inner wall 30 for receiving, holding and supporting the sidewall section of the cartridge member 10 which comprises the discharge opening 18.
The dispenser slider 14 is or can be provided with a finger print recognition 31 and the cover element 23 is or can be provided with a display unit or screen 32. Further, the cover element 23 can be equipped with a software operating button 33.
The cartridge member 10 comprises a seal or seal foil 34 which closes the discharge opening 18 tightly and which is part of a cartridge closure liner 35. The cartridge member 10 further comprises an authentication mark.
The dispensing member 12 can be equipped with an authentication reader, an authentication button and a lock and unlock activator. The pharmaceutical dispenser 1, especially the chamber 21, houses a dispensing reader on output, the electronics, an antenna, batteries, a battery charging device and a LED blinking light. All this may be provided on one or two printed circuit boards (PCB) , which are inserted into the container body shell 4.
All parts of the clamshell container 3 with the exception the electronics may be produced from plastic materials injection moulding.
The general working of the pharmaceutical dispenser 1 is explained with the help of the illustrations, especially Figure 6.
A patient receives a pharmaceutical dispenser 1 and a number of prescribed cartridge members 10.
The pharmacist enters the patient pharmacy label 9 on the inside of the container cover shell 2 and attaches the insert 8 to the attachment element or holder 7.
The cartridge member 10 is a disposable element. It may consist of at least one transparent wall 36 which enables the user to recognize the tablets or pharmaceutical products and to see them move whilst dispensing, a non-transparent bottom 37 which may be made of desiccant material and which may hold a label which can be printed with medical information, a tamper-evident cartridge seal 34 and an authentication mark.
First, the tamper-evident seal 34 is taken off the cartridge member 10. The cartridge member 10 is then placed into the container body shell 4 and clicks to its position. A cartridge door closes the cartridge member 10 discharge opening 18 tightly by pressing a non-ferrous metal closure liner 35 against the elastomer lined discharge opening 18 of the cartridge member 10. In this way, the medication is well protected against environmental influences, e.g. humidity.
Placing the cartridge member 10 in the container body shell 4 also may press an authentication button, which starts an electronic authentication system of the pharmaceutical dispenser 1. The pharmaceutical dispenser 1 reads the authentication mark and sends the read information to a central server for approval.
Upon receipt of the approval that this is the right medication, the electronics unlock the dispenser mechanism of the dispensing member 12 through the lock and unlock activator and the pharmaceutical dispenser 1 is ready to use.
The patient has to take a tablet or pharmaceutical product 11 each time the regimen prescribes him/her to do so. The system comprising the pharmaceutical dispenser 1 may set alarms to remind the patient to take medication and/or to send data to the system. These reminders may be stored in the components of the system or in the pharmaceutical dispenser 1 itself.
Reminders may be communicated visually via the screen 32 or the blinking light (LED) or audibly via a buzzer.
To take a tablet or pharmaceutical product 11, the patient opens the pharmaceutical dispenser 1 by pushing the child resistant closure or lock 6 and folding the container cover shell 2 and the container body shell 4 in their open position as shown by Figure 2. Then, the user shakes the pharmaceutical dispenser 1 a little to make sure a pharmaceutical product 11 coming from the pharmaceutical product containing chamber 28 of the cartridge member 10 is ready to be dispensed. He can see this through the transparent side wall 36 of the cartridge member 10. Then, he moves the dispensing slider 14 from the left side to the right side as indicated by the arrow 38 as shown in Fig. 6, which will start the electronics and open the cartridge door. When having reached the position as shown in Fig. 2, the receiving opening 16 of the pharmaceutical product receiving chamber 13 has come in receiving communication with the discharge opening 18 of the cartridge member 10 and a pharmaceutical product 11 falls into the pharmaceutical product receiving chamber 13 of the dispensing member 12. This can be seen through the transparent window 15 of the dispensing slider 14. The patient now moves the dispensing slider 14 back in the direction indicated by arrow 39, which will transport the receiving chamber 13 and the pharmaceutical product 11 contained therein towards the dispensing channel 20 and the receptacle 24. From the receptacle 24 the pharmaceutical product 11 is dispensed through the dispensing opening 25. When the pharmaceutical product 11 falls through the dispensing channel 20 into the receptacle 24 the electronic components 26, 27 measure the movement of the pharmaceutical product 11, and store the event's time and date in the memory of the pharmaceutical dispenser 1. After a preset time the electronics switch off automatically.
The pharmaceutical dispenser 1 only dispenses one pharmaceutical product 11 per push of the dispensing slider 14. Pharmaceutical products 11 or tablets which are pushed back in the dispensing member 12 are recorded by the electronics. In this event, no pharmaceutical product 11 enters the dispensing channel 20 although the slider 14 has been pushed or moved.
As an option, the patient may have to authenticate himself with a finger print authentication system. For this purpose the patient puts his finger on the fingerprint recognition 31 which will unlock the activator.
As an option, the pharmaceutical dispenser 1 may be time- locked. A patient can only dispense a pharmaceutical product 11 when the activator is unlocked. Unlocking takes place automatically during a programmed times pan entered in the back end system. This time span can depend on many variables, such as the regimen, the time the last pill was taken, the maximum amount of pills to be taken per day.
Alternatively, the patient can ask the doctor to unlock the pharmaceutical dispenser 1, and the doctor may send per data exchange an unlock message to the pharmaceutical dispenser 1.
After each event, or on preset times, the pharmaceutical dispenser 1 needs to communicate with a system of which it is a part. The pharmaceutical dispenser 1 can hold different communication principles to set up communication with other parts of the system.
In one configuration, the pharmaceutical dispenser 1 holds an NFC (Near Field Communication) interface in the electronics and an antenna that communicate with a dedicated program (midlet) on an NFC-enabled mobile phone. This phone sends event data to the system or other parts or embodiments of the system and can receive data back to unlock the dispensing device 1.
In another configuration, the pharmaceutical dispenser 1 holds a Bluetooth interface and antenna that works in the same way as the NFC interface.
In another configuration, the pharmaceutical dispenser 1 holds all the GSM {Global System for Mobile Communications) elements needed to make it function as a mobile data device. In this configuration the pharmaceutical dispenser 1 is autonomous and can communicate directly with the system, without a mobile phone .
The energy source, especially the battery, of the pharmaceutical dispenser 1 can be either normal batteries, or rechargeable . In the latter case, recharging may be wireless, via the NFC or Bluetooth antenna; or wired with an additional charger. In another configuration a solar charger is applied.
The pharmaceutical dispenser 1 has a user interface that helps the user to take his medication, understand the proper functioning of the pharmaceutical dispenser 1, and helps communicating with the system.
In one configuration this interface is limited to a blinking multi-coloured light (e.g., LED) that offers different messages. In a second configuration a buzzer is added which gives alarm sounds. In a third configuration a screen 32 is presented which indicates the different functions with text and logos .
There may be one or more interrogation buttons which activate the different signal and communication functions. For example, when pressing the button 33 the software will start operation, or the device LED will turn green when it's time to take a pill, and red when such is not the case. Alternatively buttons may activate the screen 32 and help the user to navigate a menu .
Although the invention has been described in relation to a cartridge member, this cartridge member can also be realized in the form of a blister package.
The cartridge member 10 may be provided with an RFID-Chip for identification .
The battery may be permanently switched "on". It is also possible, that the battery will be switched to "on" when the cartridge is inserted into the container body shell 4 and that it is switched to "off" when the cartridge is removed from the container body shell 4. Communication may also take place via the bluetooth ANT protocol, which is a low voltage communication protocol.
For making the insert 8 or a leaflet positioned in the holder 7 better readable the holder 7 may be provided with a magnifier .
An alternative embodiment of a pharmaceutical dispenser 1, which is represented by Fig. 7, comprises instead of a wall 30 and opposing chambers 20, 21 a section which comprises an insertion part 40 and the dispensing chamber 12, both housed and covered by a cover 41 and side wall sections and bottom sections of the container body shell 4. The insertion part 40 is provided with the necessary electronics and data communication devices and power sources, which are preferably arranged at a Printed Circuit Board (PCB) .
This embodiment comprises a child resistant closure 6, which has two push buttons 42a, 42b which are opposing each other arranged in the side wall of the container body shell 4 and which are in closing and releasable connection with corresponding protrusions or recesses built in the container cover shell 2. These push buttons 42a, 42b comprise resilient parts so that they may be pushed in a direction to the inside of the pharmaceutical dispenser 1 thereby releasing corresponding closure parts provided in the container cover shell 2.
This pharmaceutical dispenser 1 according to Fig. 8 comprises a discharge opening 18 provided at the cartridge member 10, wherein the discharge opening 18 is surrounded by an elastomer liner 35, 43, which is built from a soft material which is formed during injection moulding of this side wall of the cartridge member 10. This side wall may be constructed as a closure part inserted into an injection moulded box like cartridge member 10. The closure part may comprise additional section, which are equipped with a soft liner or a soft material. For instance, the outer rim portion 45 of the closure part 44 may be made of a soft material for providing a tight seal to the cartridge member and to the neighbouring dispensing member 12 when the cartridge has been inserted into the container body shell 4. In their non-dispensing position relative to each other the discharge opening 18 is covered by a closure member 46 of the dispensing member 12, which outer rim portion 47 is of a form, which matches the form of the elastomer liner 43 surrounding the discharge opening 18, wherein the outer rim portion 47 is in the closure position in a closing contact with the elastomer liner 43. To bring the receiving opening 16 of the pharmaceutical product receiving chamber 13 into a dispensing communication with the discharge opening 18 of the cartridge member 10, the dispensing member 12 has to be moved by a first step of a dispensing cycle a little bit in the direction as indicated by an arrow 48 to remove the outer rim portion 47 and elastomer liner 43 from each other. Then, in a second step, the dispensing member 12 has to be slided in a direction perpendicular to the first direction, which direction is indicated by an arrow 49. This second movement is stopped when the receiving opening 16, is in a position in front of the discharge opening 18, which is indicated by an abutment of a rib 50 extending from the dispensing member 12 against a rim part 51 of an opening 52 provided within the cover 41. These two steps of movement have to be conducted against the force of a spring 53. The spring 53 has an arc-like form and is with its one end attached to the insertion part 40 and with its opposing end attached to the dispensing member 12. The spring 43 is arranged in such a way that as well the movement in the directions as indicated by arrow 48 as the movement as indicated by arrow 49 is conducted against the force of the spring 41, which therefore has to be compressed when moving the dispensing member 12 in this way. Instead of one spring 53 it would also be possible to have an arrangement of two springs, each being attached to the insertion part 40 and the dispensing member 12, respectively and each providing a spring force directed against one of the direction as indicated by arrows 48, 49. After a pharmaceutical product 11 has been introduced into the pharmaceutical product receiving chamber 13 the dispensing member 12 is pushed back in a lateral direction against the direction as indicated by arrow 49 and then in a longitudinal direction against the direction as indicated by the arrow 48 to reach the starting position again where the closure member 46 closes the discharge opening IB of the cartridge member 10. Fig. 9 represents the position of the dispenser slider 14 after the first step of a dispensing cycle comprising the movement in direction of the arrow 48 has been completed. On the other hand this is the same position when the dispensing member 12 has been pushed back against the direction as indicated by the arrow 49.
When the dispensing member 12 is back in the starting and end position closing the discharge opening 18 the discharge opening 17 of the pharmaceutical product receiving chamber 13 is in dispensing communication with the receptacle 24 and the dispensing opening 25 of the pharmaceutical dispenser 1.
As can be seen from Fig. 10, the pharmaceutical product receiving chamber 13 comprises a bottom wall 54, a top wall 55, which constitutes a window of the dispenser slider 14 or the dispensing member 12, and two opposing side walls 56, 57. All these parts are made of a transparent or translucent material. The pharmaceutical product receiving chamber 13 comprises no front wall, because this part of the receiving chamber 13 constitutes the receiving opening 16. The back side wall of the pharmaceutical product receiving chamber 13 is constituted by a wall member 58 extending from the insertion part 40 as can be seen from Fig. 11. The wall member 58 prevents a pharmaceutical product to fall out of the pharmaceutical product receiving chamber 13 when being dispensed through the discharge opening 18 of the cartridge member 10. The insertion part 40 furthermore comprises two opposing guiding walls 59, 60 also extending from the surface of the insertion part and constituting a passage for a pharmaceutical product leaving the pharmaceutical product receiving chamber 13 in a position of the dispensing member 12, where the discharge opening 17 of the pharmaceutical product receiving chamber 13 is in dispensing communication with the receptacle 24 and/or the dispensing opening 25 of the pharmaceutical dispenser 1. The two guiding walls 59, 60 providing a passage constitute a special form of a dispensing channel 20.
The insertion part 40 comprises two slots 61, 62 wherein the dispensing member 12 or dispenser slider 14 is guided with a foot-like protrusion 63, 64, respectively, which foot-like protrusions 63, 64 are inserting in a respective slot 61, 62. Another foot-like protrusion 65 is also arranged at a rim portion of the dispenser slider 14 and is used to switch on two switches arranged on a Printed Circuit Board (PCB) , which is arranged backside the insertion part 40, wherein the switches switch the electronics "on" and "off". The foot-like protrusion 65 is inserted in and guided by a further slot 66. In the starting and end position of the dispensing slider 14 and the dispensing member 12, which is shown in Fig. 7, each of the foot-like protrusions 63, 64, 65 rest and are blocked by an extension provided in the respective slot 61, 62 and 66.
For adapting the pharmaceutical dispenser 1 to different forms of pills or pharmaceutical products 11, the pharmaceutical product receiving chamber 13 and/or the dispenser member 12 and the insertion part 40, which by position of the wall member 58 altogether define the size of the pharmaceutical product receiving chamber 13, are exchanged and interchanged but all parts are nevertheless dimensioned to fit with the size of the pharmaceutical dispenser 1, i.e. the container body shell 4. In this sense the parts are module components of a modular system.
The insertion part 40 further comprises a spring and switch member 69, which is slidable arranged in a slot of the insertion part 40 and which is provided with a resilient arm 70. In case that no cartridge member 10 is inserted in the container body shell 4, the end head 71 extends beyond the surface 72 of the insertion part 40, which faces a cartridge member 10, when inserted in the container body shell 4. When a cartridge member 10 is inserted in the container body shell 4, the cartridge member 10 abuts against the end head 71 and pushes the spring and switch member 69 against the force of the resilient arm 70 and moves the spring and switch member 69 in the direction as indicated by the arrow 48. During this movement the spring and switch member 69 is guided in a slot provided within the insertion board 40, wherein a foot-like protrusion 73 is inserted in the slot. Caused by this movement end wall 74 pushes a device, for instance a button, which indicates that a cartridge member 10 is inserted into the container body shell 4. When the cartridge member 10 has been taken out from the container body shell 4 again, the resilient arm 70 moves the spring and switch member 69 back into the position as shown in Fig. 9 and releases said button or device .
As can be seen in Fig. 11, the pharmaceutical products 11 and/or the dispensing event detecting means constituted by a light emitting element 26 and a light receiving and detecting element 27 or others are situated at such a distance to each other that during the whole movement of the dispensing member 12/dispenser slider 14 during a dispensing cycle the product receiving chamber 13 remains permanently between the two opposing detecting means 26, 27. Due to such an arrangement it is possible to detect via the detecting means 26, 27 the event that a pharmaceutical product 11 falls into the pharmaceutical product receiving chamber 13, the event that a pharmaceutical product 11 is still contained in the pharmaceutical product receiving chamber 13 and the event, that a pharmaceutical product 11 has been dispensed from the pharmaceutical product receiving chamber 13.
Fig. 12 shows a block diagram of an electronic circuit 2500 for use in a pharmaceutical dispenser 1 according to the invention and for use in monitoring and controlling administration of medications and for communication. The electronic circuit 2500 includes a processor 2502, which may, for example, be an 8-bit microcontroller, such as a P89LPC936, available from NXP Semiconductors Netherlands B. V. Of course, it will be understood that other processors or microcontrollers may also be used in the electronic circuit 2500. In some embodiments, the processor 2502 may be clocked by an external clock or crystal 2503.
The processor 2502 may include a memory 2504, for storing programmed instructions for the processor 2502 and/or data used by the electronic circuit 2500. Alternatively, the memory 2504 may include one or more external memory devices (not shown) . The memory 2504 may include non-volatile memory, such as flash memory, EEPROM memory, or static memory, and/or volatile memory, such as DRAM.
The electronic circuit 2500 is powered by a battery 2506, which may have its electrical characteristics adapted to the needs of the electronic circuit 2500 by a power regulator 2508. The battery 2506 may be a conventional replaceable battery, or a rechargeable battery, which may be recharged, for example, when the device is connected to a docking station (see below) . The power regulator 2508 may also include the ability to detect the status of the battery 2506, and provide the status information to the processor 2502. In some embodiments, an additional battery measuring device {not shown) may be used to measure the status of the battery 2506.
The processor 2502 communicates with a first transceiver 2510, which communicates wirelessly with other electronic devices via a first antenna 2512. The first transceiver 2510 uses radio frequency (RF) -based communication, such as Near Field Communication (NFC) or other wireless communication technologies suitable for short-range and/or low-power wireless communication, such as other RFID technologies, Bluetooth, or ZigBee. Where power considerations permit longer range communications, other wireless communications technologies, such as Wi-Fi, WiMAX, or various cellular technologies may be employed.
In some embodiments, where the device includes an optional display 32, 2514, the processor 2502 may further include a display driver 2516, to operate the display 2514. In some embodiments, the display driver 2516 may be implemented at least in part as driver software. In some embodiments, the display driver 2516 may be a separate device (not shown) , rather than being included in the processor 2502.
As discussed above, an optical detector 26, 27, 2518, such as a laser detector, an LED and detector, an infrared LED and detector, or other opto-electronic detection device, is used to determine when a solid preparation, such as a pill, has been dispensed by the device. A signal from the optical detector 2518 is provided to the processor 2502 for evaluation. In some embodiments, where there are multiple optical detectors (not shown} , such as where there are multiple dispensing paths for pills, in which case one such detector may be present in each such path, signals from each of these the optical detectors are provided to the processor 2502.
The electronic circuit 2500 may also include numerous control switches for adjusting the settings of the processor 2502 and/or of the electronic circuit 2500. For example, a first switch 2520 can be used to activate or deactivate the electronic monitoring and communication. A second switch 2522 can be used to detect tampering with the dispenser device by detection its removal from the container. Third and fourth switches 2524 and 2526 may be used, for example, for setting the time in hours (third switch 2524) and minutes (fourth switch 2526) . A fifth switch 2528 may be used to select use of an audible alarm, such as a buzzer 2530, which may be sounded when, for example, a patient has forgotten to dispense a medication at the time that he is supposed to take it, or when temperature and/or humidity sensors indicate that the medication is being improperly stored. It will be understood that, depending on the user interface needs of the embodiment, the control switches may be assigned to other functions.
The electronic circuit 2500 may also optionally include alarm devices, such as the buzzer 2530 and/or a vibration device 2532. These alarm devices may be activated by the processor 2502 separately or in unison, to alert a user to a variety of conditions. In some embodiments, the buzzer 2530 may be controlled to produce a variety of different sounds to alert a user to various conditions. For example, one sound may be used to warn the user that he should take a dose of a medication, another sound may be used to warn the user that he is attempting to dispense additional medication before it is safe to take another dose, a further sound may be used to warn the user that the medication in the container is running low, another sound may be used to indicate that the battery is low, and still another sound may be used to indicate to the user that temperature and/or humidity sensors are indicating that the medication is not being properly stored. In some embodiments, the buzzer 2530 may be a small speaker, capable of producing sounds including buzzing noises, speech, musical tones, or other sounds, depending on the message to be conveyed to the user.
The timing of the sounds or vibrations produced by the buzzer 2530 and/or vibration device 2532 may be controlled by the processor 2502 to convey particular meanings or warnings. For example, the processor 2502 may be programmed to use the buzzer 2530 to produce a warning sound at a predetermined time after the solid preparation should have been dispensed. For example, a short beep could be generated every minute during one hour following the time when the solid preparation should have been dispensed. The processor 2502 may be programmed to cease such warnings when the solid preparation has been dispensed through the dispenser.
The processor 2502 may be programmed to use the vibration device 2532 in a similar manner. For example, the vibration device 2532 may be switched on for one second at the time that the solid preparation should be dispensed. This may be repeated, for example, sixty minutes later, if the solid preparation is not dispensed.
In some embodiments, the electronic circuit 2500 may optionally be connected to a blocking mechanism 2534. When activated, the blocking mechanism 2534 prevents the dispenser 1 from dispensing a solid preparation. This can be achieved, for example, by sending electrical signals to a motor or solenoid to move a stopper notch between a locked and an unlocked position, as described above. The blocking mechanism 2534 may be used, for example, to prevent a user from dispensing a further dose of a medication during a time period over which a further dose is not needed or could be dangerous, or from dispensing medication which may have been damage by exposure to temperatures or humidity levels outside of an acceptable range.
In some embodiments, the electronic circuit 2500 may further include additional sensors, such as an optional humidity sensor 2536 and/or an optional temperature sensor 2538, positioned in such a way that they are able to detect the humidity and/or temperature of the pills, capsules, or other solid preparations stored in the dispenser 1 device. The humidity sensor 2536 may, for example, be a capacitive humidity sensor, a resistive humidity sensor, a thermal conductivity humidity sensor, or other suitably small, commercially available electronic humidity detection device. Similarly, the temperature sensor 2538 may be a thermistor or other resistance temperature detector, or any other suitably small, commercially available electronic temperature detector. These sensors should be positioned so that they measure the temperature and/or humidity of the pills, capsules, or other solid preparations stored in the container, bottle, or dispenser .
Generally, the electronic circuit 2500 may be configured to fit within a portion of the dispenser mechanism, as shown in earlier figures above. Individual components of the electronic circuit 2500 may be built into other portions of the dispenser, depending on their function. For example, the humidity detector 2536 and temperature detector 2538 may be positioned so that they measure the humidity and/or temperature in the locations where pharmaceutical products 11 such as pills, capsules, or other solid preparations are stored .
In addition to the features described above, the dispenser mechanism may include an identity detection device 31. Such an identity detection device may be connected to the electronic circuit 2500 to permit the user of the dispenser to be identified. An example of such an identity detection device is a fingerprint reader and identifier 31. The processor 2502 may be programmed to accept signals from such a fingerprint reader (not shown) , and to activate the dispenser only when the fingerprint read by the fingerprint reader matches a stored fingerprint. The stored fingerprint may be stored in the memory 2504, or in a memory associated with the fingerprint reader (not shown) . Since fingerprints are unique, the fingerprint of the authorized user of the device may be stored, so that only the authorized user of the device is able to activate the dispenser and to dispense a solid preparation. Other identity detection devices could also be used, including other (preferably small/portable) biometric devices, or security measures such as requiring the user to enter a combination or a personal identification number (PIN) .
By adding such an identity detection device to the electronic circuit 2500, an identity function may be implemented for the dispenser. This identity function makes it possible that only an authorized or intended user, such as the patient or a caregiver, can activate the dispenser. Using this feature, the solid preparation could not be dispensed, for example, by a child who finds the device. Additionally, the identity function may reduce the risk of taking the wrong medication, for example if there are several such dispensers being used by different people in a single household. Further, the electronic circuit 2500 may be connected to an RFID reader (not shown} in the dispenser 1. Some medication containers or cartridge members 10 may be equipped with RFID chips (not shown} that can contain information on the medication in the container. Such RFID chips may be placed on or built into the container when the container is manufactured, or at a later time, such as when a pharmacist provides the container containing medication to the patient. The RFID chip in such a container may be a standard MIFARE RFID chip, or any other type of RFID chip or tag. A drug manufacturer, physician, and/or pharmacist may store information on the RFID chip. For example, the RFID chip may include the date and time of packing a medication in the container, the content of the container, the drug type and number of pills, the expiration date of the medication, a unique identification number, patient medication intake times, length of the course of treatment, pharmacist license number, prescribing physician license number, proper storage temperature and humidity ranges, and/or other information pertaining to the solid preparation contained in the container .
The RFID reader may be used to read this information from the RFID chip attached to the container when the dispenser is attached to the container. The information can then optionally be stared in the memory 2504, and used by the processor 2502 for a variety of purposes. For example, if the dispenser includes a display, such as the display 2514, the information read by the RFID reader may be displayed. This can reduce the risk of taking the wrong medication or medication that has passed its "use by" date. The risk of taking the wrong medication may be especially pronounced when a patient needs to take two or more types of medication. When an RFID reader in the dispenser is used with an RFID chip on the container, the patient is able to read on the display which of his medications is contained in the container. This may be particularly useful when the labelling of the container has faded, for example due to frequent use or contact with water or solvents . The processor 2502 may use the information read from an RFID chip on the container for purposes such as displaying the drug contained in the container, determining when the container is almost empty (based on pill count) , automatically programming the times that the solid preparation should be dispensed or accessed so that the processor 2502 may generate alarms at the proper times, producing a warning when a medication has expired or has been stored at an unacceptable temperature and/or humidity level, preventing a user from dispensing or accessing the solid preparation at the wrong times, after it has expired, after a course of treatment has been completed, if improper temperature and/or humidity conditions may have affected the medication, and other uses for such information.
Additionally, in some embodiments, the RFID reader may also store information back into the RFID chip on the container. This means that compliance or adherence information may be available in the container chip when it is returned to the pharmacist, for example for a refill.
Referring now to Fig. 13, a system 2600 for communicating with a dispenser 1, 2601 is described. A docking station 2602 is used for electronic data communication and electronic data transfer between the dispenser and a computer (not shown) or other communication device (not shown) . Additionally, in some embodiments, the docking station 2602 may be used to recharge a rechargeable battery in the dispenser.
In some embodiments, the docking station 2602 may include a wired connection 2604, such as a USB connection or other wired connection for transferring data between the docking station 2602 and a computer or other communication device. In some embodiments, the docking station 2602 may include a wireless communication device (not shown) to allow the docking station 2602 to communicate via a wireless connection, such as through a cellular network, a wireless wide area network, or a wireless local area network. The docking station may be powered using an AC mains adapter 2606, or through power received over the wired connection 2604.
The docking station 2602 is also eguipped with an electronic reader-writer device (described below) , for reading and writing data from the dispenser. In some embodiments, where the dispenser is able to communicate directly with a wide area network or cellular network, or where the communication is handled by a portable reader, such as a mobile phone equipped with an NFC reader, the docking station 2602 may not be needed for the dispenser to communicate its data.
Fig. 14 shows a block diagram of an electronic reader-writer device 2700 suitable for use in the docking station 2602 of Fig. 26. The reader-writer device 2700 includes a second transceiver 2702 with a second antenna 2704 for communicating with the first transceiver 2510 in the dispenser, as shown in Fig. 12. When used with the reader-writer device 2700 in a docking station, the dispenser may preferably use a low power, short range communication technology, such as Near Field Communication (NFC) , Bluetooth, or ZigBee. Other communications technologies suitable for longer range wireless communications may also be used, such as WiFi or other wireless local area network (WLAN) technology. Of course, the communication technology used by the reader- writer should be compatible with the communication technology used by the dispenser. Alternatively, a physical electrical connection between the dispenser and the docking station could be used, assuming that the dispenser includes an appropriate interface. For example, if the dispenser has a USB interface, it may be possible to connect it to the docking station {or directly to a USB-equipped external computer) using the USB interface. A physical interface, such as a USB interface, may also be useful for charging a rechargeable battery in the dispenser.
The reader-writer device 2700 also may include a wired connection interface 2706. The wired connection interface 2706 may be, for example, a USB interface through which the reader- writer device connects the docking station to an external computer system. Other types of wired connections, such as a serial connection or a wired Ethernet connection could also be used.
The reader-writer device 2700 may be powered from an AC adapter (not shown) through a voltage regulator 2708. Alternatively power may be received from other sources, such as through the wired connection interface 2706.
Once the data are transferred from the dispenser to an external computer (through a docking station, such as the docking station 2602, shown in FIG. 13, when the dispenser is unable to communicate directly with the external computer) , the external computer can transfer the data to a remote computer via a wide area network, such as the Internet. The dispenser may also receive data via a wide area network through an external computer (and, possibly a docking station) . Further, programming or instructions for the electronic circuit 2500 of the dispenser, as shown in Fig. 12, may be sent from a computer at a remote location, and communicated to the dispenser via the Internet or other wide area network. The remote computer may, for example, be accessible by a physician, pharmacist, or other medical professional who is overseeing the therapy compliance or adherence of the patient who is using the dispenser. It will be understood that in some embodiments, where the dispenser includes wide- area networking or cellular communication capabilities, the dispenser may be able to connect to the Internet and/or the remote computer system without using an external computer or docking station to establish the connection. It will also be understood that in some embodiments/ a mobile device, such as an NFC-equipped mobile telephone may be used to communicate between the remote computer and the dispenser.
Such a system is shown in Fig. 15. The system 2800 of Fig. 15 includes one or more dispensers 2802, which include the electronic circuitry 2500 as shown in Fig. 12. For purposes of illustration, these dispensers include NFC communication circuitry, which allows them to transfer data between a dispenser 2802 and an NFC-equipped mobile telephone 2804. The NFC-equipped telephone 2804 can wirelessly communicate via a wide area network 2806, such as a cellular communication network or the Internet with a remote database 2808, which collects and stores information from the dispenser (s) 2802. The remote database 2808 can be accessed (through the wide area network 2806 or a different wide area network) by a remote computer 2810, which may also remotely send instructions to the dispenser (s) 2802 through the wide area network 2806 and the mobile telephone 2804.
It will be understood that the communication path may be somewhat different, depending on the technology used. For example, if no NFC-equipped mobile phone is available, the dispenser may use a docking station {not shown) connected to a computer (not shown} to communicate with the remote database 2808 and/or the remote computer 2810. Alternatively, in some embodiments, the dispenser may be able to directly connect to the wide area network, and communicate with the remote database 2808 and/or the remote computer 2810 without using an NFC-equipped mobile telephone or a docking station.
As can be seen in Fig. 15, the therapy compliance or adherence monitoring and communication means provided can be mobile. The dispenser 2802 is arranged for monitoring the therapy compliance or adherence of a patient, and for remotely allowing or disabling the dispensing of a solid preparation, to help ensure therapy compliance or adherence. Wired and/or wireless communications can be used to report therapy compliance or adherence to the remote computer 2810, which may be used by a physician, pharmacist, or other medical caregivers to monitor compliance or adherence. Additionally, administration of therapy may be controlled or adjusted from the remote computer 2810, depending on the therapy compliance or adherence reporting received. Further, as can be seen, in addition to the Internet, other communication technologies may be used in the remote surveillance and control of therapy compliance or adherence, including mobile platforms, such as the mobile telephone 2804, and the like.
When a container with a solid preparation is issued by a pharmacist, the dispenser 2802 according to an embodiment of the invention is put in place on the container, such that solid preparations may be taken from the container by pushing a button on the dispenser 2802. The dispenser 2802 has a built-in clock/calendar so that when the button is operated and a solid preparation, such as a pill or tablet is dispensed, the date and time of this event are stored in a memory in the dispenser 2802. Similarly, the times of other events, such as recording of temperature and or humidity readings can be stored. The dispenser 2602 may optionally be programmed so that the solid preparation may only be dispensed at pre-programmed times, depending on the medication prescribed, and the instructions of the physician and/or pharmacist. This may prevent a patient from taking too many doses, since the dispenser 2802 is blocked after a dosage is taken, and will only dispense a further dose when the next dosage should be taken. It should also be noted that this option of programming the dispenser provides the opportunity to register and regulate a combination therapy, whereby more than one type of medication must be taken, as will be described in greater detail below.
Next, the date and time stamp at which a dose was dispensed, and/or other information, such as temperature and/or humidity data are transferred over the wide area network, which may be a mobile telephone network, such as GSM or GPRS, to the patient's record in the remote database 2808. As shown in the figure, in some embodiments, this transfer may be accomplished by reading the data from the dispenser using a Near Field Communication (NFC} mobile phone 2804, or by using another gateway for conversion of data from NFC or Bluetooth devices into SMS and GPRS data. It will be understood that other communication options, as described above are also possible. In some embodiments, other data collected by the dispenser may also be transferred along with the compliance or adherence data. For example, data concerning the temperature and humidity of the stored medication may be transferred. These data may indicate whether the pills, capsules, or other solid preparations are being stored in appropriate conditions. This information may be used to send the patient and/or the pharmacist or physician a warning if the medication is being stored at an inappropriate temperature or humidity. This data could also be used, for example, to dynamically adjust the expiration date of a medication, depending on its storage conditions, or to prevent a patient from taking medications which could become dangerous if stored for a period of time in an inappropriate manner. Other information, such as the battery status may also be transferred. This data may, for example, be used to warn the patient or pharmacist if a non- rechargeable battery in the dispenser device will need to be replaced. The patient record in the database 2808 contains various kinds of patient information, including the therapy compliance records for the patient received from one or more dispensers. This information can be securely accessed by physicians, pharmacists, or other authorized medical caregivers from a remote computer 2810 over a wide area network, such as the Internet. The compliance or adherence data may be correlated and analyzed in the remote database 2808 or on the remote computer 2810, and if mal- compliance/adherence or non-compliance/adherence are detected, the patient can be warned, for example via an SMS service or the like. In some embodiments, when non- compliance/adherence or mal-compliance/adherence are detected, a call centre, pharmacist, and/or care organization may receive an instruction to call the patient to discuss his mal- or noncompliance/adherence .
A dispenser according to an embodiment of the invention can also communicate with another dispenser, either directly, through a docking station, or through a network. An advantage of such a dispenser is that it is possible to regulate an order in which two or more medications are taken. For example, in AIDS treatment, a combination of drugs may be prescribed, which need to be taken in a strict order and according to a strict time schedule. For example, the prescription schedule can specify that a first medication should be taken first, followed within one hour by a second medication. If the patient forgets that he has already taken the required dosage of the first medication, he may try to "correct" this by taking another dose of the first medication. Such noncompliance/adherence can have serious effects on the health of the patient and on the effectiveness of the treatment. By communicating with each other, the dispensers according to an embodiment of the invention can reduce this problem. Using the above-described example, a first dispenser for a container containing the first medication can block further dispensing of the first medication until it receives a communication indicating that a second dispenser for a container containing the second medication has dispensed a dose of the second medication. Thus, a new dose of the first medication can only be taken after the required dose of the second medication has been taken. The time for taking the second medication can be set by the second dispenser receiving a communication indicating that the first medication has been dispensed by the first dispenser, causing the second dispenser to set a buzzer or other alarm feature to provide a warning one hour later that the second medication should be taken. By use of dispensers that are able to communicate with each other, according to an embodiment of the invention, a strict medication regime can be followed with reduced effort by the patient and with an increased rate of compliance/adherence.
It should be noted that in accordance with various embodiments of the invention, communication between the dispensers can be achieved directly between the dispensers, or via an indirect method. For example, the dispensers may communicate through a base station, or through a wireless network. Also, the dispensers could communicate indirectly through a database, such as the remote database 2808 shown in Fig. 15, or through another computer or communication device that receives and sends communications to dispensers in accordance with various embodiments of the invention.
The dispenser according to the invention can be used for dispensing various sizes and shapes of solid preparations. This feature makes it possible to use the dispenser several times for different solid preparations. The dispenser according to the invention can be used in combination with many types of cartridge members 10, providing a reservoir for the solid preparations 11 to be dispensed through the dispenser 1. Preferably a cartridge member 10 has such dimensions that the dispenser 1 can be carried by a patient .
The detector can be a laser detector. Further, a dispenser system can comprise a dispenser 1 including an electronic circuit and an energy supply for monitoring, controlling and/or communication. In such an embodiment the energy supply includes a battery and the electronic circuit includes a microcontroller, wherein the electronic circuit preferably includes a first transceiver. Such an embodiment may further comprise an alarm signal generator, wherein the alarm signal generator can be selectable to generate an audible signal by means of a buzzer. The alarm signal generator can include a vibrator. Further, a dispenser system can further comprise an electromechanical blocking mechanism. The dispenser system can further include an LCD display for transferring messages. Further, the system can comprise a docking station. In this case, the docking station has a communication link for the exchange of data with an auxiliary data communication device. Further, the docking station is arranged for data communication with an auxiliary device in the form of a mobile platform, such as a mobile phone. The system comprising an electronic circuit and a first transceiver may comprise a docking station which includes a second transceiver, wherein the first and second transceiver use Near Field Communication technology. Additionally, the docking station can also include an USB interface, wherein the communication link includes an USB- connection. A cartridge member 10 and a clamshell container 3 may cooperate as a dispenser device. A method of monitoring a patient's medication compliance or adherence can comprise
a. providing a dispenser system which dispenser system tracks at least one type of patient medicine compliance/adherence data, said dispenser system being connected to a pharmaceutical dispenser 1,
b. providing a wave energy transmitter and a power source to drive said transmitter for transmission of said patient's medicine compliance/adherence data to a remote location, said transmitter being electronically connected to said dispenser system for said transmission and said data transmitter and power source being connected to said pharmaceutical dispenser 1,
c. providing a receiver at said remote location and providing a computer to which said receiver inputs patient compliance/adherence data,
d. having either said dispenser system or said computer programmed to store the prescribed medicine dosage and regime of said pharmaceutical dispenser 1,
e. having either said system, dispenser or computer programmed to calculate compliance/adherence requirements for each dosage administration for the prescription period of the medicine and for comparing the actual medicine consumption or dispenser usage with the compliance/adherence requirements .
Finally, the pharmaceutical dispenser 1 may be equipped with an absorber function obtained by an absorber component.

Claims

Claims
Pharmaceutical dispenser (1) , especially a pocket dispenser, comprising
a clamshell container (3) comprising a container body shell (4) and a container cover shell (2) which are swivel- mounted attached to each other,
wherein the container body shell (4) incorporates an insertable and exchangeable cartridge member (10) containing a supply of pharmaceutical products (11) and incorporates an, especially insertable and exchangeable, dispensing member (12) having a pharmaceutical product receiving chamber (13) and cooperating with and/or being a part of a dispenser slider (14), which dispensing member
(12) is arranged to bring by lateral movement of the dispenser slider (14) alternatively a receiving opening
(16) of the product receiving chamber (13) in receiving communication with a discharge opening (18) of the cartridge member {10} and a discharge opening (17) of the product receiving chamber (13) in dispensing communication with a dispensing opening (25) provided in the container body shell (4) .
Pharmaceutical dispenser (1) according to claim 1, wherein the discharge opening (17) of the product receiving chamber (13) can be brought into dispensing communication with a receiving opening (19) of a dispensing channel (20) or of a passage, which dispensing channel or passage is formed in the container body shell (4) .
Pharmaceutical dispenser (1) according to claim 2, wherein the dispensing channel (20) or the passage is arranged and designed to be in a delivery communication with a receptacle (24) and/or the dispensing opening (25) provided in the container body shell (4) .
Pharmaceutical dispenser (1) according to claim 1, wherein the container body shell (4) comprises at least one chamber (21, 22) or a volume containing electronic components .
Pharmaceutical dispenser (1) according to claim 1 or 2, wherein the container body shell (4) comprises a dispensing detecting component (26, 27) for detecting and/or monitoring the dispensing of each pharmaceutical product (11) , which is dispensed.
Pharmaceutical dispenser (1) according to one of the preceding claims, wherein the insertable cartridge member (10) comprises a pharmaceutical product containing chamber (28) of a height to accommodate only one layer of pharmaceutical products (11) .
Pharmaceutical dispenser (1) according to one of the preceding claims, wherein the pharmaceutical product receiving chamber (13) of the respectively used dispensing member (12) is adapted to the size and the amount of the pharmaceutical product (11) to be received and to be dispensed by the product receiving chamber (13) during a dispensing cycle.
Pharmaceutical dispenser (1) according to one of the preceding claims, wherein the insertable and/or exchangeable cartridge member (10) and/or the dispensing member (12) are module components of a modular concept which are formed to be inserted into the container body shell (4) .
Pharmaceutical dispenser (1) according to one of the preceding claims, wherein the dispenser slider (14) and/or the dispensing member (12) is moved against the force of a spring (29, 53) from a position where the discharge opening (17) of the product receiving chamber (13) is in dispensing communication with the dispensing opening (25) to a position where the receiving opening (16) of the product receiving chamber (13) is in receiving communication with the discharge opening (18) of the cartridge member (10).
10. Pharmaceutical dispenser (1) according to one of the preceding claims, wherein the dispenser slider (14) is manually operated.
Pharmaceutical dispenser (1) according to one of the preceding claims, wherein the cartridge member (10) is equipped with guiding elements separating and guiding one pharmaceutical product (11) contained in the cartridge member (10) towards the discharge opening (18) of the cartridge member (10).
Dispenser (1) according to one of the preceding claims, further comprising an electronic cicuit (2500) and/or an energy supply for monitoring, controlling, indicating and/or communication, especially data communication.
Dispenser (1) according to claim 4 or claim 12, wherein the electronic components and/or the electronic circuit (2500) comprise:
a sensor (25, 18) or dispensing detecting components (26, 27) configured to detect a dispensing event of a single dose of the medication/pharmaceutical product (11) from the dispenser;
a memory (2504) that stores information associated with the dispensing event; and
a transceiver (2510) that, preferably wirelessly, transmits the information associated with the dispensing event to an external device. Dispenser (1) according to claims 12 or 13, wherein the electronic circuit (2500) is configured to receive information and/or commands from an external source or an external device.
System (2600, 2800) comprising a dispenser (1) according to one or more of the claims 1-14 and an external database (2800) .
PCT/EP2011/062940 2010-07-29 2011-07-27 Pharmaceutical product dispenser WO2012013723A1 (en)

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