EP1973512B1 - A container for a blister package - Google Patents

A container for a blister package Download PDF

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Publication number
EP1973512B1
EP1973512B1 EP20070700173 EP07700173A EP1973512B1 EP 1973512 B1 EP1973512 B1 EP 1973512B1 EP 20070700173 EP20070700173 EP 20070700173 EP 07700173 A EP07700173 A EP 07700173A EP 1973512 B1 EP1973512 B1 EP 1973512B1
Authority
EP
European Patent Office
Prior art keywords
blister package
container
compartment
user
ejection structure
Prior art date
Legal status (The legal status 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 status listed.)
Not-in-force
Application number
EP20070700173
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German (de)
French (fr)
Other versions
EP1973512A1 (en
Inventor
Ulf ÅHAG
Ulf Blom
George Sioustis
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ALK Abello AS
Original Assignee
ALK Abello AS
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 ALK Abello AS filed Critical ALK Abello AS
Publication of EP1973512A1 publication Critical patent/EP1973512A1/en
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Publication of EP1973512B1 publication Critical patent/EP1973512B1/en
Not-in-force legal-status Critical Current
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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
    • B65D83/0445Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments
    • B65D83/0463Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments formed in a band or a blisterweb, inserted in a dispensing device or container
    • 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
    • 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

Definitions

  • Document DE3514312 discloses a container comprising all the technical features of the preamble of claim 1.
  • the switch may provide a tactile indication, or indication may be given by means of an electrically or mechanically generated sound.
  • the container registers "compliance" for the interval, and if not, it registers "non-compliance” for the interval. After a certain amount of intervals, the number of compliances or non-compliances out of a number of intervals may be presented to the user or transmitted via an interface to an external device.
  • more than one registration of non-compliance out of five may result in a red light signal or a warning tone to be transmitted to the user, whereas one or less non-compliances out of five may result in a green colour, or no warning tone being transmitted to the user.
  • the container could be adapted always to calculate the compliance from a period comprising a fixed number of intervals. I.e. each time a new interval is started, the evaluation of compliance is based on the latest interval and a fixed number of previous intervals. This provides a moving average, i.e. an average over a fixed preceding period of time.
  • cover means for covering an opening of the container in a closed condition of the container are provided, the cover means being movable between a closed end position and an open end position, the cover means in the open end position having been rotated about a longitudinal axis of the container in order to form a stand for positioning of the container in an inclined position on a horizontal surface.
  • at least part of the movement of the cover means from the closed end position to the open end position actuates movement of the ejection structure from an idle position to an ejected position, and vice versa.
  • the container has a timer, and the following functions are performed by processing means in the container:
  • the container is adapted to determine interactive compliance as follows:

Description

    INTRODUCTION
  • The present invention relates to a container for a blister package e.g. containing doses of a pharmaceutical composition, the container comprising a housing forming a compartment for the blister package, means for indicating towards a user an appropriate time of taking a dose of the pharmaceutical composition, and means for detecting a user's access to the blister package and thereby access to the pharmaceutical composition.
  • BACKGROUND OF THE INVENTION
  • A blister package is typically a transparent, moulded piece of plastic forming a cavity or a plurality of cavities which are sealed with a peelable or breakable foil or a sheet of cardboard. Blister packages are typically used to package and display an item of merchandise or for packing doses of pharmaceutical compositions, sweets, chewing gum etc. A blister package is sometimes referred to as a bubble pack.
  • In connection with blister packages with pharmaceutical compositions, dispensers and containers exist with timer means for noticing the user when to take a dose. Some of the existing systems automatically record the removal of a dose from a blister package, or record compliance of the removed doses with a prescribed medication plan for the pharmaceutical composition in question. The user may e.g. receive a signal which indicates when to take a dose of the medical composition, or which indicates how much overdue the last dose is.
  • WO 03/003970 discloses a method for identifying blister packages with medicaments, and WO 99/43283 discloses a device for indicating an event of administration.
  • Document DE3514312 discloses a container comprising all the technical features of the preamble of claim 1.
  • DESCRIPTION OF THE INVENTION
  • It is an object of the present invention to improve the existing containers for blister packages. The invention provides a container of the kind mentioned in the introduction in which the container further comprises an ejection structure or rejection structure to which the blister package can be fixed as claimed in claim 1. Ejection structure" and "rejection structure" are to be understood as interchangeable expressions in the following specification. The ejection structure is movable towards an open position for moving the blister package in an outward direction out of the compartment and movable towards a closed position for moving the blister package in an inward direction into the compartment.
  • Since the blister package is moved into, and out of the compartment by the ejection structure which forms part of the container, sliding contact between the container and the blister package during insertion or removal of the blister package from the compartment may be avoided completely. This enables enhanced functioning of the container, e.g. with an improved guiding of the blister package into and out of the compartment and in particular with respect to the use of blister packages of various kinds, sizes and conditions. Due to the guided insertion of the blister package into the compartment, the user may feel more certain about correct positioning of the blister package in the compartment, and sensors for detecting presence of a blister package or a user's access to a blister package may operate more reliably. Furthermore, the avoidance of direct sliding contact between the blister package and the container may increase the protection of the blister package, and unwanted opening and exposure of a dose of a pharmaceutical compound due to wear can be avoided.
  • The ejection structure may be guided by sliding contact between a surface of the ejection structure and a surface of the housing, and to improve the ease of movement, matching surfaces could form a sliding bearing or a linear roller bearing. The ejection structure may preferably be guided in the housing by a linear slide allowing a linear movement of the ejection structure relative to the housing, and the position of the ejection structure may preferably be supported by friction between a surface of the ejection structure and a surface of the housing. In one embodiment, the ejection structure moves back and forth in a slot which is dimensioned to receive the blister package - i.e. the compartment is formed by a slot in the housing. To facilitate insertion of the blister package into the slot, the slot may form an opening with a bevelled or chamfered edge which guides the blister package into the slot.
  • The linear slide may define an end-stop beyond which further movement of the ejection structure relative to the housing is prevented. Separation of the ejection structure from the housing is thereby prevented.
  • User-access to the blister package may be detected e.g. by surveillance of the blister package itself in the device, e.g. by mechanical, optical or other means which is triggered by movement of the blister package itself. Blister packages may, however, be of varying size, type and condition. As an example, the size or shape of the blister packages may be different from blister package to blister package, and some users may already have removed a portion of a blister package before inserting the remaining portion into the compartment. The varying conditions of blister packages render detection of movement of the blister package difficult and inaccurate. In one embodiment of the invention, the user-access is detected by detection of movement of the ejection structure rather than by surveillance of the blister package itself. Accordingly, increased safety in the detection of the user-access may be obtained independent on the type, size and condition of the blister package. The user-access may be detected by any mechanical switching means, by an optical detector, by a magnetically triggered switch or by magnetic-inductive means arranged to detect movement of the ejection structure relative to the housing. As an example, user-access may be determined by a mechanical switch which is embedded in the linear guide, or which is located along the linear guide to be triggered when the ejection structure is moved in the outward or inward direction.
  • The user-access may also be detected optically, e.g. by interruption of a beam of electromagnetic radiation, by a magnetically sensitive switch located on one of the housing and the ejection structure or by electrical induction triggered by the movement of the ejection structure relative to the housing.
  • User-access may also be registered by manual activation of an alternative registration structure, e.g. a compliance button switch etc.
  • To provide a clear indication to the user that the user-access has been recorded, the switch may provide a tactile indication, or indication may be given by means of an electrically or mechanically generated sound.
  • In one embodiment, user-access is only registered by movement of the ejection structure in one of the outward and inward directions. As an example, user-access may not be registered upon movement of the ejection structure out of the compartment but only when the ejection structure and thus also the blister package are moved into the compartment.
  • In one embodiment, the container is adapted to store a blister package containing doses of a pharmaceutical composition, e.g. pills, tablets, capsules, suppositories, dragées, chewing gums, powder, granule, gels, a liquid etc., e.g. for parenteral use, such as adapted for buccal or sublingual administration. If such a composition is designed for administration at a fixed time interval, in the following refereed to as "in accordance with a medication plan", i.e. not too often or seldom, support may be provided to the user by a compliance structure adapted to indicate a time at which the latest user-access occurred, i.e. when the user gained access to the blister package latest. The compliance structure may further be adapted to provide the duration since last user-access.
  • In a more advanced embodiment, the compliance structure contains information relating to a medication plan and automatically alerts the user when it is time to take a dose of the pharmaceutical composition. As an example, the compliance structure could be adapted to switch between an attentive state in which the user is supposed to take a dose of the drug compound, and a non-attentive state in which the user is supposed to wait for the state to change to the attentive state before taking further doses. The switching from the non-attentive state to the attentive state could be triggered by a timer which is programmed in accordance with medication plan for the drug compound in question. The switching from the attentive state to the non-attentive state could be triggered by user-access, e.g. by registration of movement of the ejection structure. User-access may thereby reset the timer which once again counts when the next dose of the pharmaceutical composition is due and switches the container to the attentive state.
  • In one embodiment, user-access is only registered when the compliance structure is in the attentive state. When the compliance structure is in the non-attentive state, i.e. when it is not time for the next dose of the pharmaceutical composition, neither movement of the ejection structure, nor manual operation of a push button switch resets the timer which counts the time until the next dose of the pharmaceutical composition is due. In another embodiment, user-access may only be registered, and the timer thus be reset, by manual operation of the push button switch when the compliance structure is in the attentive state. I.e. movement of the ejection structure does not reset the timer. This reduces the electrical consumption of the device if the user moves the blister package into or out of the container when the compliance structure is in the non-attentive state, and the feature thus saves battery and further allows replacement of the blister package without resetting the timer.
  • In a more advanced embodiment, the compliance structure is adapted to read a medication plan from the blister package, e.g. by means of any technique for electronic reading known in the art, e.g. magnetically, optically etc. In one embodiment, the container comprises a plurality of reading sensors, e.g. adapted to read individual medication plans for a plurality of doses included in a blister package. In this embodiment, the sensors could also be utilised for recording the history of the medication, e.g. that dose no. 1 was taken at a specific point in time, dose no. 2 at another point in time etc. This feature facilitates documentation of a medication which is based on a number of different doses included in a single blister package.
  • The user may indicate a desire for obtaining information relating to the compliance in a very simple way by use of a push button switch. As an example, the user may push a pre-specified number of times, e.g. three times to request information about the state of the compliance structure, i.e. if it is time for a new dose of the pharmaceutical composition or optionally - when it is time for the next dose.
  • To indicate towards the user if the ejection structure and thus also the blister package are not in the closed position, the container may further comprise a second timer adapted to determine a period of time in which the ejection structure has not been in the closed position. The compliance structure may be adapted only to switch from the attentive state to the non-attentive state if the timer has determined that the ejection structure has not been in the closed position in a time interval which is longer than a pre-specified time interval.
  • The attentive state may be indicated to the user by a notification signal such as a light, sound, or vibration signal, or a combination there between, or the container may even transmit a notification signal by wireless communication, e.g. via Bluetooth communication to an external device. Wireless communication of the notification signal facilitates remote surveillance of a patient, e.g. at a hospital or at a home for people who require care.
  • The user may not notice the notification signal, e.g. due to noise or other circumstances. In order to save battery or in order not to disturb unnecessarily, the notification signal may be transmitted as repeated signals at pre-specified periods of time after the shift of the compliance structure from the non-attentive state to the attentive state. In one embodiment, the pre-specified period of time increases between each transmission. As an example, one notification signal lasting e.g. 15 seconds may be transmitted once the compliance structure switches to the attentive state, after 5 minutes a subsequent notification signal may be transmitted if the container is still in the attentive state. After e.g. 15 minutes yet another notification signal could be transmitted etc.
  • If the user ignores the signal, the container may be adapted, e.g. after a pre-selected number of repeated signals, to shift automatically back to the non-attentive state. In this case, the container may record a non-compliance insignia for that period. According to medication instructions for a specific pharmaceutical composition, a number of subsequent "correct" points in time at which a dose of the pharmaceutical composition is to be taken, i.e. a specific interval between "correct" user-accesses. The container may be adapted for each interval to determine if user-access has been established, i.e. e.g. if the ejection structure has been moved. If the ejection structure has been moved, the container registers "compliance" for the interval, and if not, it registers "non-compliance" for the interval. After a certain amount of intervals, the number of compliances or non-compliances out of a number of intervals may be presented to the user or transmitted via an interface to an external device.
  • The number of compliances within a period could be transformed into a more easily understandable identifier of the compliance, e.g. numeral score, or into a signal given by illumination of a light emitting diode (LED) or similar light on an outer surface of the container, e.g. in a accordance with a colour code, or a sound signal may be transmitted in accordance with a code which indicates the number of compliances or non-compliances for a period involving a certain number of intervals.
  • As an example, more than one registration of non-compliance out of five may result in a red light signal or a warning tone to be transmitted to the user, whereas one or less non-compliances out of five may result in a green colour, or no warning tone being transmitted to the user. The container could be adapted always to calculate the compliance from a period comprising a fixed number of intervals. I.e. each time a new interval is started, the evaluation of compliance is based on the latest interval and a fixed number of previous intervals. This provides a moving average, i.e. an average over a fixed preceding period of time.
  • In one embodiment, the container comprises an interface structure e.g. based on an USB interface etc by which the container may communicate with an external computer system. As an example, the compliance data may be communicated to a computer, e.g. at health centre, in order to monitor the medication and compliance. Alternatively, or additionally, the container could be adapted for wireless communication or it may comprise a memory module which is replaceable, e.g. an SD-memory module of the kind known from electronic appliances. This would allow the user to forward the compliance date to an external computer system e.g. by regular mail.
  • To increase the area of visual appearance of a light signal on an outer surface of the container, the light may be generated by illuminating means such as an LED which is arranged to transmit the light transversely into a prism, e.g. a prism which forms part of a front cover of the container. The prism may spread the light and make the signal more easily detectable.
  • In one embodiment, the prism may form a shape which indicates the type of drug substance for which the medication instructions are provided and which is comprised in the blister package.
  • The blister package is fixed to the ejection structure by a gripping means comprising two parts forming a slot into which the blister package is inserted. The gripping means comprises a back member and an adjacent front member located relative to each other so that a blister card can be received there between. The back member and front member may e.g. be movable relative to each other in a direction towards and away from each other in a manner corresponding to a clip or clothes-pin. The clip-like gripping means may be dimensioned relative to the slot into which the blister package is received so that the back and front members are pressed together by the inner surfaces of the slot.
  • In one embodiment, the gripping means is adapted to support a blister package of the kind wherein a number of doses, e.g. tablets or pills are located in individual bulges or cavities in a surface of the blister package. In this embodiment, at least one of the back and front members may comprise a gripping structure adapted at least partly to encircle a portion of one of the bulges in the surface of the blister package. The gripping means may in particular prevent rotation of the blister package during the movement of the ejection structure into and out of the container. As an example, the gripping means may comprise one or more support profiles which extend along one or more outer edges of the blister package and thus prevent rotation of the blister package relative to the ejection structure. The support profiles may e.g. comprise grooves in which the edges of the blister package are received.
  • In one embodiment, the container comprises detection means capable of detecting presence of a blister package which is fixed to the ejection structure. As an example, the detection means may alert the user if no blister package is present in the container for a certain amount of time. In another embodiment, the container may comprise detection means capable of determining the content, e.g. the number of doses which remains in a blister package, and to inform the user when a certain level is reached. This will allow the user to procure a new blister package in due time. The detection means could form part of the gripping means. In one embodiment, the detection means is divided into two separate sensors which register the contents of a blister with two rows of doses. In this embodiment, the sensors may e.g. determine the number and locations of doses in each of the two rows of doses.
  • The container may be adapted to accommodate further blister packages, e.g. in separate compartments.
  • The container may comprise a tearing-off edge along which a portion of the blister package may be torn off. This may e.g. facilitate removal of one single dose or one row of doses from the blister package. For this purpose, the ejection structure moves between different locations which are determined by tactile indications. By movement between two of these locations, one row of doses is moved across the tearing off edge whereby that row of doses may be tom off.
  • In one embodiment, the container is shaped so that it can be located in an upright position on a table, e.g. as a frame for a picture with an un-foldable stand on a back surface or like a book which can be unfolded. In the embodiment wherein the container is opened like a book, the opening of the container may register the user-access.
  • In one embodiment, the container comprises one single operation button by which various functions may be controlled depending on a number of times the button is operated. As an example, a single activation may indicate user-access, three activations within a certain time, e.g. three activations within 5 seconds may indicate that the user requests data concerning compliance, and a larger number of activations, e.g. 5 may indicate a desire of switching the compliance structure off. In this case, the container may be used as a regular container for storing blister packages.
  • In one example, cover means for covering an opening of the container in a closed condition of the container are provided, the cover means being movable between a closed end position and an open end position, the cover means in the open end position having been rotated about a longitudinal axis of the container in order to form a stand for positioning of the container in an inclined position on a horizontal surface. Preferably, at least part of the movement of the cover means from the closed end position to the open end position actuates movement of the ejection structure from an idle position to an ejected position, and vice versa. These features provide an easy-to-use, very functional and aesthetically appealing container with a cheap structure that can be easily manufactured.
  • In a second aspect, the invention provides a container with a compartment for a blister package, and a blister package as claimed in claims 1, said blister package forming at least one row of cavities with doses, the row extending between a first end portion and a second end portion, characterized in that at least one of the end portions and an adjacent cavity cooperate with gripping means of the container to facilitate movement of the blister package into the compartment and out of the compartment. In one embodiment, the blister package comprises a plurality of weakening lines facilitating division of the blister package between each of the cavities whereby the user may tear off a used portion of the blister package when removing a dose. In this embodiment, it is an object not to provide the weakening line between at least one of the end portions and an adjacent cavity. This facilitates that the user can not, by accident, remove that end portion from the blister package, and that end portion may thus serve for engagement with the gripping means of the container.
  • DETAILED DESCRIPTION OF THE INVENTION
  • In the following, preferred embodiments of the invention will be described in further details with reference to the drawing in which:
    • Fig. 1 shows three different views of a first embodiment of a container according to the present invention,
    • Fig. 2 shows a variant of the container of Fig. 1 with a removable stand,
    • Fig. 3 shows a logic flow diagram of the container of Fig. 1,
    • Fig. 4 shows another variant of the container of Fig. 1 wherein the second compartment is opened,
    • Fig. 5 shows the slots into first and second compartments of the container of Fig. 1,
    • Fig. 6 shows yet another variant of the container of Fig. 1 with a tear-off edge for separation of one row of doses from a blister package in the container,
    • Figs 7 to 9 show three different views of an example of a container, Fig. 10 shows a partial cross section of parts of the example of Figs 7 to 9, and
    • Fig. 10a shows a detail of Fig. 10.
    • Figs 1, 2 and 4 - 6 show a first embodiment of a container 1 according to the invention.
  • As shown in Fig. 1, the container 1 of the first embodiment comprises a first slot 2 forming an opening into a first compartment and a second slot 3 forming an opening into a second compartment. The first compartment is for storing a first blister package and the second compartment is for storing a second blister package. The first blister package is an active blister package from which a pharmaceutical composition is consumed, and the second blister package is a "spare" blister package which can be moved to the first compartment when the blister package stored in the first compartment is empty. The container comprises a housing 4, means for indicating towards a user an appropriate time of accessing the blister package, e.g. by means of a sound signal, fixing means 5 for holding the blister package, and means for detecting a users access to a blister package in the compartment.
  • Insertion and withdrawal of the blister into an out of the first compartment is facilitated by an ejection structure which is operated by the handle 6 which can slide back and forth on the outer surface of the container and thereby moves the blister package into and out of the compartment. The rejection structure is movable towards an open position for moving the package in an outward direction out of the first compartment and movable towards a closed position for moving the package in an inward direction into the first compartment. When the user moves the rejection structure, the movement is registered as being a users access to the blister package in the first compartment. The rejection structure is attached to the housing via a linear guide providing linear sliding of the rejection structure relative to the housing.
  • The container comprises a single compliance push button switch 7 by which the user may activate various functions depending on the number of activations of the switch within a pre-specified period of time.
  • The container comprises signal transmitting means 8 which transmits a coloured light signal where the colour indicates the compliance of the user, i.e. how many times within a specified period the user has complied with a medication plan. In addition, the container comprises a transmitter to transmit a sound signal which indicates when it is time for a user to take a dose of the pharmaceutical composition in the blister package. In this embodiment, the container shifts from a non-attentive to an attentive state. When the user moves the rejection structure out of the closed position and back into the closed position, i.e. when moving the blister package back into the first compartment after having taken the dose, the container shifts back from the attentive state to the non-attentive state and compliance is registered for the interval in which the dose is taken in accordance with the medication plan.
  • To support correct medication, the container has a timer, and the following functions are performed by processing means in the container:
    • A time which is counted by the timer is reset by registration of user-access to the blister package. In practise this registration is achieved either by moving the rejection structure to an open position and back to the closed position or by a users activation of compliance button 7.
    • Alarm is transmitted after a specific period, e.g. after 24 hours when the medication plan prescribes a dose of the pharmaceutical composition once a day.
    • Snooze function if dose is not taken after 15 minutes and 30 minutes from the first alarm
    • Remind alarm if dose is not taken within 6 hours after first alarm.
    • Remind alarm if dose is not taken within 12 hours after first alarm.
    • If dose is not taken later within 24 hours+ 12 hours, a count is set to "out of compliance"
  • In addition, the container is adapted to determine interactive compliance as follows:
    • "Adherence" is defined as the sum of compliance and persistence
    • "Compliance" is taking the medication as prescribed by the medication plan, e.g. once daily.
    • "Persistence" is staying on treatment over the whole treatment regiment
    • "Compliance time" is defined as 24 hours plus reminder time, max 12 hours (total 24+12=36 hours). Compliance time starts always from default time (start time set by user when resetting the device). "Default time" is defined as the time the user sets as alarm time by pressing compliance button > 5 seconds. "Compliance time frame" = "compliance time" - 6 hours to "compliance time" +12 hours.
  • Example of alarm time (4 times reminding alarm after the first alarm for the worst case)
    First day XX:XX Default time + Sound 1
    Second day XX:XX Alarm 2. Not taken (as example)
    Second day, snooze XX:XX+15min Alarm 2. Not taken (as example)
    Second day, snooze XX:XX +30min Alarm 2. Not taken (as example)
    Second day XX:XX +12 hours Alarm 2.
    - Not taken: Not compliance
    - Taken: Compliance
    Third day XX:XX Alarm 2. First alarm on default time.
    Etc.
  • The device communicates compliance with the user according to the logarithm shown below. The compliance logarithm shall be counted seven days moving average. When restarted/reset the compliance shall start the calculation with a full 7 days compliance in the log. See example below. The numbers below represents the sum of taken tablets during compliance time. Seven days back (if restarted /reset calculating with the fictive seven day full compliance):
    5 - 7 days inside compliance (Green)
    3 - 4 days Attention compliance (Orange)
    0 - 2 days Out of compliance (Red)
  • Example of compliance function
  • Figure imgb0001
  • The signal transmitting means 8 comprises a light emitting diode (LED). The LED illuminates a prism with a shape which indicates the type of pharmaceutical composition for which the medication plan is programmed in the compliance structure. In the present embodiment, the shape indicates a straw, and the pharmaceutical compound is directed towards allergy against grass. Three-color codes shall be used to signalize compliance: Green, Orange and Red. Green means "Inside compliance", Orange means "Attention compliance", and Red means "Out of compliance".
  • The transmitter to transmit a sound is adapted to transmit a sound level at 74 dB with background 65 dB measured 8 inches from the device. Alarm is activated in 30 seconds or recommended action is performed.
  • Following alarms/sounds shall be used:
    Alarm Sound description Comment
    Alarm/sound 1 xx "Default time set" Two short peeps within 0,5seconds
    Alarm 2 xx-xx-xx-xx-xx- "Take a dose"
    Alarm 3 xxx-xxx-xxx-xxx "Push blister package back into the compartment"
    Alarm 4 xx---xx---xx---xx--- "Press compliance button"
  • The container is adapted to be operated on batteries 9.
  • The container is specifically made for a blister package 10 comprising two columns 11, 12 of doses in tablet form. Each column forms a row with 5 doses, and between each row, the blister package comprises a weekend line 13 at which the row may be tom off from the remaining portion of the blister package.
  • The gripping structure comprises a front member and a back member which is located on the opposite side of the blister package 10 (not visible in Fig. 1). The front member comprises two elements 14, 15, one of which comprises an arched portion which partly encircles a protruding portion of the blister package, i.e. partly encircles one of the portions in a last row in one of the columns.
  • Fig. 2 shows a variant of the container according to the first embodiment of the invention with a removable stand 16 which is attachable to the back surface of the container and allows the container to be positioned in an upright position on a table.
  • Fig. 3 shows a logic flow diagram.
  • Fig. 4 shows another variant of the container according to the first embodiment wherein a lid 17 is hinged to the housing 4 and enables complete opening of one of the compartments, in this case the second compartment.
  • Fig. 5 shows the slots 2, 3 into the first and second compartments. The first slot comprises first and second enlarged openings 18, 19 and an intermediate portion 20. The slot thus matches the shape of a blister package 10 of the kind disclosed in Fig. 1, i.e. with two rows with doses, e.g. tablets or pills.
  • Fig. 6 shows yet another variant of the container according to the first embodiment with a tear-off edge 21 for separation of one row 22 of doses from the blister package. In this variant, the handles 23, 24 for moving the rejection structure and thus the blister package into and out of the compartment is provided with a tactile indication of the locations at which the doses in the blister package is in a correct position relative to the tear-off edge 21, e.g. when a weakened line of the blister package is located adjacent the tear-off edge.
  • Figs 7 to 10a show an example of a container Similar reference numerals refer to similar elements or elements of the same function as in the embodiment of figs 1 to 6.
  • The container 1 comprises a housing 4, which may on its front side shown in Fig. 7 comprise not shown indicating means such as an LED or LCD and/or a compliance structure such as has been described in the above, e.g. in the form of a push button or the like. The housing 4 is in the form of a sheet of material, such as plastic, bent to form a compartment for a blister package 10. An ejection structure in the form of an ejection sheet 30 is housed inside the housing 4 in a closed end position of the container 1 shown in Fig. 7. In an intermediate position shown in Fig. 8 and in an open end position shown in Fig. 9 the ejection sheet 30 has been ejected from the housing 4 to project from the side of the housing 4. Fig. 10 shows the ejection sheet 30 in the ejected position corresponding to Figs 8 and 9, and Fig. 10a shows a detail of the ejection sheet 30 of Fig. 10.
  • The ejection sheet 30, which is seen best in Figs 9 and 10, has been bent such that a front side 30b and a back side 30c lie substantially coplanar with a front side 4b and a back side 4c, respectively, of the housing 4. A curved connection portion 30a of the ejection sheet 30 abuts a similarly shaped connection portion 4a of the housing 4 in the closed end position of the container 1 shown in Fig. 7. The ejection sheet 30 comprises a linear slide in the form of a slot 31 engaging a inward facing projection 32 of the front side 4b of the housing 4 to ensure a smooth and linear movement of the ejection sheet 30 between the open and closed end positions of the container 1. The projection 32 may form a stop, e.g. in the form of a wider portion (not shown), to ensue that the ejection sheet 30 at all times remains attached to the housing 4.
  • The ejection sheet 30 further comprises fixing means in the form of an insert 33 for securing the blister package 10 to the ejection sheet 30. As is shown in Fig. 10a the insert 33 comprises two projections, which are able to hold a blister package 10 inserted as shown by means of the arrow of Fig. 10a, i.e. a sheet portion of the blister package 10 is forced to enter a secured or fixed position. In the secured or fixed position of the blister package the projections push against each other on either side of the sheet portion of the blister package 10. In a not shown variant of the second embodiment of the invention two blister packages are held in the insert 33, the second blister package for example being held between one of the projections and a third projection of the insert.
  • The ejection sheet 30 comprises a recess 35, which provides a better grip on the blister package 10.
  • The back side 30c of the ejection sheet 30 may as an alternative or supplement comprise further fixing means in the form of apertures (not shown) corresponding to tablet projections 10a of the blister package 10 in order to provide an even better attachment of the blister package 10 on the ejection sheet 30. In case of a blister package 10 with ten tablet projections the back side would comprise ten correspondingly positioned and shaped apertures. In this variant the projections face the back side 30c of the ejection sheet 30, they may however in other embodiments face the opposite way. In another not shown variant the apertures are provided on a separate sheet positioned to be coplanar with the back side 30c of the ejection sheet 30.
  • In a not shown variant of the example not part of the invention the ejection structure does not comprise the front and back sides 30b, 30c. In this variant the insert 33 in itself pushes the blister package 10 out of the housing during the ejecting movement. However, the shown variant is preferred since the front and back sides 30b, 30c provide support for the blister package 10.
  • Means for detecting when a user gains access to the container 1 may as examples be provided as a sensor in the insert 33 or at an end of the projection 32.
  • The container 1 further comprises cover means in the form of a cover 34 for covering an opening of the container 1 in a closed condition of the container 1 as is shown in Fig. 7. As can be seen from Figs 8 and 9 the opening extends from a top edge along a side edge and to a bottom edge of the housing 4. Parts 34a, 34b and 34c correspond to the top, side and bottom edges, respectively. The cover 34 is movable between the closed end position of Fig. 7 and the open end position of Fig. 9, the cover 34 being in the intermediate position of Fig. 8 between the said two end positions. The cover 34 is attached to the ejection sheet 30 by means of stub shafts (not shown) embedded in corresponding apertures 36 of a side portion of the ejection sheet 30. In an alternative not shown variant the stub shafts are replaced by a through-going shaft extending through both apertures 36.
  • When wanting to open the container 1 in order to gain access to a tablet, a user moves the cover 34 from the closed end position of Fig. 7 to the intermediate position of Fig. 8. This may be done by gripping the housing 4 with one hand and the cover 34 with the other, pulling them away from each other. This provides a linear slide of the cover 34 actuating movement of the ejection sheet 30 from its idle position in the housing 4 by pulling it out of the side edge opening of the housing 4 by means of the stub shafts. The housing 4 is formed such that when the cover 34 and ejection sheet 30 enter the intermediate position of the container 1 of Fig. 8, the cover 34 is released from the linear slide and is able to rotate about a longitudinal axis of the container 1 defined by the stub shafts. The user then rotates the cover 34 to the second end position shown in Fig. 9. Now, easy access to the blister package 10 is provided. The user takes out the blister package 10, breaks off or pushes out a tablet, and reinserts the blister package 10 into the insert 33. In order to close the container 1 an inverse operation is carried out by the user such as to bring the container 1 from the open end position to the closed end position.
  • In the open end position shown in Fig. 9 the rotated cover 34 forms a stand for positioning of the container 1 in an inclined position on a horizontal surface such as a table (not shown). The container 1 preferably comprises spring means (not shown) or other suitable retaining means known to the skilled person for retaining the cover 34 in the rotated position shown in Fig. 9 such as to not collapse when positioned on said horizontal surface.
  • In variants of the example not part of the invention further spring means may be provided for biassing the ejection sheet 30 towards the ejected position, such spring means for example being actuated by means of a button or the like.

Claims (13)

  1. A container (1) for a blister package (10), the container (1) comprising:
    - a housing (4) forming a compartment for the blister package (10),
    - means for indicating towards a user an appropriate time of accessing the blister package (10), and
    - means for detecting a user's access to a blister package (10) in the compartment,
    wherein the container (1) further comprises an ejection structure to which the blister package (10) may be fixed, the ejection structure being movable towards an open position for moving the package (10) in an outward direction out of the compartment and movable towards a closed position for moving the package in an inward direction into the compartment,
    characterized in that
    i) the blister package (10) can be fixed to the ejection structure by a gripping means comprising two parts forming a slot into which the blister package (10) is inserted, wherein the gripping means (5,14,13) for fixing the blister package (10) to the ejection structure comprises a back member and an adjacent front member, the gripping means being adapted to receive a blister card between the back member and the front member,
    wherein the back member and front member are movable relative to each other in a direction towards and away from each other and
    ii) the container (1) further comprises a handle (6) for operating the ejection structure, wherein the handle (6) can slide back and forth on the outer surface of the container (1) and thereby move the blister package (10) into and out of the compartment.
  2. A container (1) according to claim 1, wherein the user's access to the blister package (10) in the compartment is detected by detection of movement of the ejection structure relative to the housing (4).
  3. A container (1) according to claims 1-2, wherein the ejection structure is attached to the housing (4) via a linear slide (31) allowing a linear movement of the ejection structure relative to the housing (4).
  4. A container (1) according to claims 1-3, wherein separation of the ejection structure from the housing (4) is prevented.
  5. A container (1) according to any of the preceding claims, further comprising detection means capable of detecting presence of a blister package (10) fixed to the ejection structure.
  6. A container (1) according to any of the preceding claims, further comprising a compliance structure adapted to indicate a time at which the user latest gained access to the blister package (10) in the compartment.
  7. A container (1) according to any of the preceding claims, further comprising processing means adapted to determine a compliance level indicating a difference between a desired consumption frequency for the substance and a frequency of receipts of the registration signal.
  8. A container (1) according to any of the preceding claims, further comprising a timer adapted to determine a period of time in which the ejection structure has not been in the closed position.
  9. A container (1) according to claim 8, wherein the compliance structure is adapted only to switch from the attentive state to the non-attentive state if the timer has determined that the ejection structure has not been in the closed position in a time interval which is longer than a pre-specified time interval.
  10. A container (1) according to any of claim 9, wherein at least one of the back and front members comprises a gripping structure adapted at least partly to encircle a protruding portion of the blister package (10).
  11. A container (1) according to any of the preceding claims, further comprising a supplementary compartment for an additional blister card.
  12. A combination comprising a container (1) according to any of claims 1-11 with a compartment for a blister package (10) and a blister package (10), said blister package (10) forming at least one row of cavities with doses of a pharmaceutical composition, the row extending between a first end portion and a second end portion, at least one of the end portions and an adjacent cavity cooperate with gripping means of an ejection structure adapted to move the blister package (10) into or out of the container (1).
  13. A combination according to claim 12, wherein the blister package (10) comprises a plurality of weakening lines facilitating division of the blister package (10) between each of the cavities whereby the user may tear off a used portion of the blister package (10) when removing a dose.
EP20070700173 2006-01-18 2007-01-18 A container for a blister package Not-in-force EP1973512B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US75962106P 2006-01-18 2006-01-18
DKPA200600079 2006-01-18
PCT/DK2007/050003 WO2007082543A1 (en) 2006-01-18 2007-01-18 A container for a blister package

Publications (2)

Publication Number Publication Date
EP1973512A1 EP1973512A1 (en) 2008-10-01
EP1973512B1 true EP1973512B1 (en) 2012-10-17

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EP20070700173 Not-in-force EP1973512B1 (en) 2006-01-18 2007-01-18 A container for a blister package

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US (2) US20100236973A1 (en)
EP (1) EP1973512B1 (en)
CN (1) CN101384237B (en)
CA (1) CA2637212A1 (en)
HK (1) HK1126955A1 (en)
WO (1) WO2007082543A1 (en)

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Also Published As

Publication number Publication date
EP1973512A1 (en) 2008-10-01
WO2007082543A1 (en) 2007-07-26
US20130008818A1 (en) 2013-01-10
HK1126955A1 (en) 2009-09-18
CN101384237B (en) 2012-08-22
US20100236973A1 (en) 2010-09-23
CN101384237A (en) 2009-03-11
CA2637212A1 (en) 2007-07-26

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