WO2015067747A1 - Apparatus with language reset feature and method for controlling such an apparatus - Google Patents

Apparatus with language reset feature and method for controlling such an apparatus Download PDF

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Publication number
WO2015067747A1
WO2015067747A1 PCT/EP2014/074030 EP2014074030W WO2015067747A1 WO 2015067747 A1 WO2015067747 A1 WO 2015067747A1 EP 2014074030 W EP2014074030 W EP 2014074030W WO 2015067747 A1 WO2015067747 A1 WO 2015067747A1
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WO
WIPO (PCT)
Prior art keywords
language
user input
user
input
predefined
Prior art date
Application number
PCT/EP2014/074030
Other languages
French (fr)
Inventor
Ilona Eggert
Michael Caspers
Original Assignee
Sanofi-Aventis Deutschland Gmbh
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Publication date
Application filed by Sanofi-Aventis Deutschland Gmbh filed Critical Sanofi-Aventis Deutschland Gmbh
Publication of WO2015067747A1 publication Critical patent/WO2015067747A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT 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
    • G16H40/60—ICT 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
    • G16H40/63—ICT 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 local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2485—Ampoule holder connected to rest of syringe
    • A61M2005/2496—Ampoule holder connected to rest of syringe via pivot
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M2005/31588—Constructional features or modes of drive mechanisms for piston rods electrically driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F9/00—Arrangements for program control, e.g. control units
    • G06F9/06—Arrangements for program control, e.g. control units using stored programs, i.e. using an internal store of processing equipment to receive or retain programs
    • G06F9/44—Arrangements for executing specific programs
    • G06F9/451—Execution arrangements for user interfaces
    • G06F9/454—Multi-language systems; Localisation; Internationalisation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT 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
    • G16H20/17—ICT 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 via infusion or injection

Definitions

  • the invention relates to an apparatus having a language setting feature.
  • the invention relates to a medical device or apparatus, such as an injection device or an analyte measurement device (e.g. a glucose meter) which allows a first set language to be reset at a later time.
  • a medical device or apparatus such as an injection device or an analyte measurement device (e.g. a glucose meter) which allows a first set language to be reset at a later time.
  • the device or apparatus may have a user interface for outputting messages to a user, having at least two input elements, each input element being actuatable by a user action, having a control unit for controlling the apparatus as a function of a user input by means of the input elements, and having a storage for storing a message language setup variable, wherein the control unit is configured to perform a language setting step, during which the value of the message language setup variable is selected as a function of a user input, and wherein the control unit is configured to select the language of messages to be output by means of the user interface as a function of a message language setup variable.
  • the apparatus may be a medical device, in particular a medicament injection device.
  • the medical device or apparatus can be an injector, for example a hand-held injector, especially a pen-type injector, that is an injector of the kind that provides for administration by injection of medicinal products from one or more multidose cartridges.
  • an injector for example a hand-held injector, especially a pen-type injector, that is an injector of the kind that provides for administration by injection of medicinal products from one or more multidose cartridges.
  • the present invention relates to such injectors where a user may set the dose.
  • the drug agents may be contained in two or more multiple dose reservoirs, containers or packages, each containing independent (single drug compound) or pre-mixed (co-formulated multiple drug compounds) drug agents.
  • Certain disease states require treatment using one or more different medicaments. Some drug compounds need to be delivered in a specific relationship with each other in order to deliver the optimum therapeutic dose.
  • the present patent application is of particular benefit where combination therapy is desirable, but not possible in a single formulation for reasons such as, but not limited to, stability, compromised therapeutic performance and toxicology.
  • a diabetic with a long acting insulin (also may be referred to as the first or primary medicament) along with a glucagon-like peptide-1 such as GLP-1 or GLP-1 analog (also may be referred to as the second drug or secondary medicament).
  • the proposed drug delivery device provides separate storage containers or cartridge retainers for two or more active drug agents. These active drug agents are then combined and/or delivered to the patient during a single delivery procedure. These active agents may be administered together in a combined dose or alternatively, these active agents may be combined in a sequential manner, one after the other.
  • the drug delivery device also allows for the opportunity of varying the quantity of the medicaments. For example, one fluid quantity can be varied by changing the properties of the injection device (e.g., setting a user variable dose or changing the device's "fixed" dose). The second medicament quantity can be changed by manufacturing a variety of secondary drug containing packages with each variant containing a different volume and/or
  • the drug delivery device may have a single dispense interface.
  • This interface may be configured for fluid communication with a primary reservoir and with a secondary reservoir of medicament containing at least one drug agent.
  • the drug dispense interface can be a type of outlet that allows the two or more medicaments to exit the system and be delivered to the patient.
  • the combination of compounds from separate reservoirs can be delivered to the body via a double-ended needle assembly.
  • This provides a combination drug injection system that, from a user's perspective, achieves drug delivery in a manner that closely matches the currently available injection devices that use standard needle assemblies.
  • One possible delivery procedure may involve the following steps:
  • a dispense interface to a distal end of the electro-mechanical injection device.
  • the dispense interface comprises a first and a second proximal needle.
  • the first and second needles pierce a first reservoir containing a primary compound and a second reservoir containing a secondary compound, respectively.
  • a dose dispenser such as a double-ended needle assembly, to a distal end of the dispense interface. In this manner, a proximal end of the needle assembly is in fluidic communication with both the primary compound and secondary compound.
  • GUI graphical user interface
  • the micro-processor controlled control unit may determine or compute a dose of the secondary compound and preferably may determine or compute this second dose based on a previously stored therapeutic dose profile. It is this computed combination of medicaments that will then be injected by the user.
  • the therapeutic dose profile may be user selectable. Alternatively, the user can dial or set a desired dose of the secondary compound.
  • the device may be placed in an armed condition.
  • the optional armed condition may be achieved by pressing and/or holding an ⁇ " or an "Arm" button on a control panel.
  • the armed condition may be provided for a predefined period of time during which the device can be used to dispense the combined dose.
  • the user will insert or apply the distal end of the dose dispenser (e.g. a double ended needle assembly) into the desired injection site.
  • the dose of the combination of the primary compound and the secondary compound (and potentially a third medicament) is administered by activating an injection user interface (e.g. an injection button).
  • Both medicaments may be delivered via one injection needle or dose dispenser and in one injection step. This offers a convenient benefit to the user in terms of reduced user steps compared to administering two separate injections.
  • Complex devices such as the drug delivery device described above, analyte measurement devices such as glucose meter, and / or the like, usually comprise user interfaces by means of which the device outputs messages to the user to inform him about the device operation status, to offer him a selection of possible operation steps, to request a particular operation step to be performed by the user, and / or the like. Since those devices are usually sold in more than one country or in countries with more than one official language, many devices have the capability to prompt these messages in different languages. For example, some devices perform a language setting step when the device is powered up for the first time, during which the user may select his preferred language from a language selection menu. The device may then be configured to output messages in the language selected by the user during the language setting step. Alternatively, the language may also be preselected by the manufacturer or by the vendor of the device. If the device is for example intended to be sold in Germany, the vendor may preselect the language "German" for the device.
  • Devices that are capable of outputting messages in different languages are advantageous in that they may be sold in different countries without the need of providing it with new software that is adapted to a particular language.
  • an object of the present invention to provide an apparatus such as a medical device for example for ejecting a fluid, which provides the possibility to reset the language of the messages output on a user interface, in particular without interfering the regular operation of the apparatus.
  • An object of the present invention is also to provide a method for controlling such an apparatus.
  • an apparatus in particular a medical device, such as a device for ejecting a fluid, measuring analyte data etc., having a user interface for outputting messages to a user, having at least two input elements, each input element being actuatable by a user action, having a control unit configured to control the apparatus, for example based at least in part on a user input by means of the input elements, and having a storage for storing a message language setup variable, wherein the control unit is configured to perform a language setting step, during which a value of the message language setup variable is selected as a function of a user input, wherein the control unit is configured to select the language of messages to be output by means of the user interface as a function of the message language setup variable, and wherein the control unit is further configured to perform the language setting step upon detection of a predefined user input, the predefined user input comprising actuation of at least two of the input elements.
  • a method for controlling such an apparatus comprising the steps of: performing a language setting step, during which the value of a message language setup variable is selected as a function of the user input; and outputting messages on a user interface, wherein the language of the messages is selected as a function of the message language setup variable, wherein the language setting step is performed upon detection of a predefined user input, the predefined user input comprising actuation of at least two input elements.
  • the apparatus may be a delivery device, especially a drug delivery device such as a medical device configured to eject a drug agent (e.g. a dose of a medicament) such as an infusion device or an injection device, for instance an insulin injection pen.
  • a drug agent e.g. a dose of a medicament
  • injection devices may be used either by medical personnel or by patients themselves.
  • type-1 and type-2 diabetes may be treated with patients themselves by injection of insulin doses for example once or several times per day.
  • the apparatus may be a medical device configured to deliver (i.e. eject) at least two drug agents from separate cartridges situated in two separate retainers.
  • the apparatus may for instance be configured to deliver (i.e. eject) a two- component adhesive from separate cartridges comprising a first component of the two- component adhesive (i.e. a binder) and a second component of the two-component adhesive (i.e. a hardener) respectively.
  • a first component of the two- component adhesive i.e. a binder
  • a second component of the two-component adhesive i.e. a hardener
  • the apparatus has a user interface for outputting messages to a user.
  • the user interface may in particular comprise a display such as an LCD or TFT display to present messages containing text and/or graphic pictograms or the like to a user.
  • the user interface may also comprise a speaker to output a sound, in particular a voice message.
  • the apparatus has at least two input elements, each input element being actuatable by a user action.
  • Such an input element may for example be a button like as a push button, a slide button or a rotary button that may be actuated by the user by pressing, sliding or turning the button.
  • Such a button may also be actuated by holding the button for a predefined time such as holding down a push button, holding displaced a slide button or holding rotated a rotary button for a predefined time.
  • a user input element may also be a sensor such as an optical sensor, a magnetic sensor, a mechanical sensor, in particular a proximity sensor or an acceleration sensor or the like.
  • Such a sensor may be configured to be activatable by a particular user action. For example, the sensor may be configured to detect whether the user manipulates, attaches or detaches a component of the apparatus such as for example a cap.
  • the apparatus comprises a control unit for controlling the apparatus.
  • the control unit is preferably a micro-processor control unit comprising a micro-processor and a storage containing commands for controlling the apparatus.
  • the control unit is configured to control the apparatus as a function of user input by means of the input elements. This is understood to mean, that the control units is configured such that at least some steps performed by the control unit to control the apparatus are a function of user input by means of the input elements.
  • the control unit may be configured such that a particular control step is performed if the user activates a particular input element. For example, if the apparatus is a medicament injection device, medicament ejection may be triggered by the control unit if a user presses a particular ejection button of the device.
  • the apparatus has a storage for storing a message language setup variable.
  • the storage may for example be a RAM, a ROM, a flash memory, a hard disk or the like.
  • the value of the message language setup variable indicates a selected language of the apparatus or indicates that no language has been selected yet.
  • the message language setup variable may be a variable of numerical type, such as an integer type, wherein a particular number value of the variable is attributed to a particular language, such as "0" for "no language selected", "1 " for English, "2” for German, "3” for French etc.
  • the language setup variable may also be of a string type, wherein a particular string value of the variable is again attributed to a particular language, such as "NN” for “no language selected”, "EN” for English, “DE” for German, “FR” for French etc.
  • a particular string value of the variable is again attributed to a particular language, such as "NN” for “no language selected”, "EN” for English, “DE” for German, “FR” for French etc.
  • Other implementations of the message language setup variable are of course possible as well.
  • the control unit is configured to perform a language setting step, during which the value of the message language setup variable is selected as a function of a user input. Such a step is often performed on the first use of an apparatus, so that the user may select his preferred language on the first use. Alternatively, such a language setting step may also be performed with the manufacturer or vendor to preselect a language.
  • the user may for example select one of a number of languages from a menu by actuating particular buttons of the apparatus.
  • the apparatus may comprise an "UP” and a “DOWN” button to navigate within a language selection menu and an "OK” button to confirm a language that is currently selected in the menu.
  • the control unit is configured to set the value of the message language setup variable as a function of the user input, for example to "DE” or "2" if the user selects "German" during the language setting setup.
  • the control unit is configured to select the language of messages to be output by means of the user interface as a function of the message language setup variable.
  • the control unit may be configured to select from a number of messages stored in a storage a message with the appropriate content and with the language according to the value of the message language setup variable.
  • the storage may contain messages with a particular content such as "Press OK for confirmation" in different languages.
  • the user interface comprises a speaker
  • the storage may contain voice messages with a particular content in different languages so that the control unit may select a voice message with the appropriate content and with the selected language and output the message by means of the speaker.
  • the control unit is configured to perform the language setting or resetting step upon detection of a predefined user input, the predefined user input comprising actuation of at least two of the input elements.
  • Actuation of at least two of the input elements means that the user has to actuate at least a first and a second input element during a single user input, for example by simultaneously and/or sequentially actuating the at least two input elements.
  • the predefined user input may comprise simultaneous actuation of a first and of a second button of the device.
  • a single user input means that actuation of the at least two input elements triggers one particular step controlled by the control unit, presently the language setting or resetting step.
  • sequential actuation of input elements wherein each actuation causes a step controlled by the control unit is not regarded as a predefined user input comprising actuation of at least two of the input elements but rather as multiple user inputs. For example, navigation in a menu by pressing "UP” and “DOWN” buttons several times is not regarded as a predefined user input comprising actuation of at least two of the input elements since after each single actuation of either the "UP” or "DOWN” button the control unit controls another menu item to be selected.
  • the apparatus described above allows a user to select a different language for the messages output on the user interface during regular operation of the apparatus, i.e. after the language setup variable has already been set, for example during a language setting step performed on first use.
  • the apparatus does not have to be equipped with an additional button to trigger the language setting step.
  • the predefined user input does not occupy the original function of the at least two of the input elements, as these input elements may still be configured for another function when pressed alone or at least independently from the predefined user input.
  • actuation of only one of the at least two of the input elements may cause a step to be performed that occurs more frequently during normal operation of the apparatus.
  • the language setting step is only performed if both of these at least two of the input elements are actuated according to the predefined user input. This control takes into account that apparatuses usually only comprise a limited number of input elements.
  • An inadvertent triggering of the language setting or resetting step may be rendered even less likely if the apparatus comprises more than two, for example at least three or at least four input elements, and if the predefined user input comprises actuation of more than two, for example at least three or at least four of the input elements.
  • the predefined user input comprises sequential actuation of at least two of the input elements. This is understood to mean that the user first has to actuate a first input element and subsequently a second input element in order to trigger the language setting step to be performed.
  • the predefined user input may in particular comprise sequential actuation of at least two input elements within a predefined maximum time interval.
  • the control unit may distinguish between the predefined user input and multiple user inputs in which the user individually actuates these input elements. For example the user may have to press a first button and then a second button within 1 s after pressing the first button in order to trigger the language setting step to be performed. If he presses the second button more than 1 s after pressing the first button, the control unit will detect two separate user inputs.
  • Such a sequential actuation in particular within a maximum time interval is less likely to be performed inadvertently by the user.
  • the two input elements may trigger different control steps to be performed if actuated alone or with a time difference longer than a predefined maximum time interval.
  • the predefined user input comprises actuation of a first input element and subsequent actuation of a second input element while still actuating the first input element.
  • the predefined user input may comprise pressing and holding down a first button and then actuating another input element, while still holding down the first button. Actuation of one input element while at the same time still actuating another input element will often require the user to operate the apparatus with both hands. It is therefore very unlikely that the user triggers the language setup step when operating the apparatus with one hand only.
  • This embodiment is therefore in particular advantageous for apparatuses such as medical injection devices which are designed to be operated during normal operation with one hand only.
  • the predefined user input may in particular comprise actuation of two input elements which are located remote from each other, for example on two different sides of the apparatus. This increases the likelihood that a user needs two hands to actuate both of the input elements so that unintentional actuation of both elements is unlikely.
  • the predefined user input comprises actuation of at least one input element for a predefined time period.
  • the predefined user input may comprise actuation of a button for a predefined time period such as pressing and holding down the button for a predefined time period such as for example at least 400 ms.
  • the apparatus comprises a coupling portion for attaching thereto a detachable element and an input element configured as a sensor to detect attachment or detachment of the detachable element, and wherein the predefined user input comprises attaching of the detachable element to the coupling portion and/or detaching the detachable element from the coupling portion.
  • the apparatus may comprise a coupling portion for attaching thereto a cap to protect parts of the apparatus when not in use.
  • the apparatus may furthermore comprise a sensor like an optical or magnetic sensor to determine whether the cap is attached to the coupling portion or not. Attachment or detachment of the cap may then be regarded as user action to actuate the sensor, the sensor constituting the input element.
  • the predefined user input may comprise pressing a first button of the apparatus and then detaching the cap from the apparatus while still holding down the first button.
  • the apparatus comprises a portion being movable relative to the apparatus by rotation and/or translation and an input element configured as a sensor to detect movement of said portion, and wherein the predefined user input comprises moving said portion.
  • said portion may be a cover or door part movable between an open and a closed position for accessing a component within the apparatus such as a medicament cartridge within a medicament injection device.
  • the apparatus may for example comprise a hinge or a guide track for moving a cover or door part.
  • a sensor provided for detecting movement of said portion may be used as input element that is actuated by the user moving the portion, in particular as part of a predefined user input for triggering the language setting step.
  • This embodiment as well allows complex user input sequences to be defined as predefined user input for triggering the language setting or resetting step which are easy to remember and to perform by the user but unlikely to be performed inadvertently.
  • the predefined user input comprises the following, preferably in the given order:
  • the storage is configured to store user operation related data in at least one user operation data variable and wherein the control unit it is configured to maintain the value of the at least one user operation data variable during the control sequence performed upon detection of the predefined user input.
  • User operation related data is understood to designate data, which is directly connected to the use of the apparatus by the user.
  • Such user operation related data may in particular include data that is used by risk mitigation functions of the apparatus such as by a function tracking the total operation time of the apparatus or by a function monitoring medicament cartridge expiring.
  • the user operation related data may also include data with specific user-related information such as the daily bolus, the user's name, age or weight or the like.
  • the language of the apparatus may also be reset by means of a hard reset, during which the apparatus is reset to the original factory settings.
  • the first use of the apparatus after a hard reset is often similar to the original first use of the apparatus, so that an initial language selection may be possible.
  • all user operation related data is deleted from the apparatus and thus lost. This may raise safety concerns, in particular for medical devices, as the further operation of the apparatus is no more adapted to the actual needs of the user.
  • the embodiment described above instead allows resetting the message language setup variable while at the same time maintaining the user operation related data.
  • data which is important for a safe use of the device is unchanged after resetting the language.
  • the control unit is configured to output a confirmation message, in particular a confirmation sound, upon detection of the predefined user input.
  • a confirmation message in particular a confirmation sound
  • the apparatus is a medical device, in particular a medicament injection device. If a medical device is set to an incorrect language, the user may be hindered to use the device anymore or his security may even be at risk when he uses the device improperly because he does not understand the messages output on the user interface. The possibility of resetting the language therefore in particular improves the user safety of medical devices.
  • the apparatus is hand-held.
  • Hand-held apparatuses in particular hand-held medical devices, are often use by a layman such as patients
  • Fig. 1 illustrates a perspective view of a delivery device with an end cap of the
  • Fig. 2 illustrates a perspective view of the delivery device distal end showing the cartridge
  • Fig. 3 illustrates a perspective view of the delivery device illustrated in Fig. 1 or 2 with one cartridge retainer in an open position;
  • Fig. 4 illustrates a dispense interface and a dose dispenser that may be removably mounted on a distal end of the delivery device illustrated in Fig. 1 ;
  • Fig. 5 illustrates the dispense interface and the dose dispenser illustrated in Fig. 4 mounted on a distal end of the delivery device illustrated in Fig. 1 ;
  • Fig. 6 illustrates one arrangement of a needle assembly that may be mounted on a distal end of the delivery device
  • Fig. 7 illustrates a perspective view of the dispense interface illustrated in Fig. 4;
  • Fig. 8 illustrates another perspective view of the dispense interface illustrated in Fig.
  • Fig. 9 illustrates a cross-sectional view of the dispense interface illustrated in Fig. 4.
  • Fig. 10 illustrates an exploded view of the dispense interface illustrated in Fig. 4;
  • Fig. 1 1 illustrates a cross-sectional view of the dispense interface and needle
  • a drug delivery device such as the device illustrated in Fig. 1 ;
  • Fig. 12 illustrates a perspective view of a delivery device comprising a sensor for detecting whether the cap is attached to the device or not;
  • Fig. 13 shows a flow chart for detection of a predefined user input;
  • Fig. 14 shows a flow chart of an exemplary language setting step.
  • the drug delivery device illustrated in Fig. 1 comprises a main body 14 that extends from a proximal end 16 to a distal end 15. At the distal end 15, a removable end cap or cover 18 is provided. This end cap 18 and the distal end 15 of the main body 14 work together to provide a snap fit or form fit connection so that once the cover 18 is slid onto the distal end 15 of the main body 14, this frictional fit between the cap and the main body outer surface 20 prevents the cover from inadvertently falling off the main body.
  • the main body 14 contains a micro-processor control unit, an electro-mechanical drive train, and at least two medicament reservoirs.
  • a dispense interface 200 is mounted to the distal end 15 of the main body 14, and a dose dispenser (e.g., a needle assembly) is attached to the interface.
  • the drug delivery device 10 can be used to administer a computed dose of a second medicament (secondary drug compound) and a variable dose of a first medicament (primary drug compound) through a single needle assembly, such as a double ended needle assembly.
  • the drive train may exert a pressure on the bung of each cartridge, respectively, in order to expel the doses of the first and second medicaments.
  • a piston rod may push the bung of a cartridge forward a pre-determined amount for a single dose of medicament.
  • the piston rod is retracted completely inside the main body 14, so that the empty cartridge can be removed and a new cartridge can be inserted.
  • a control panel region 60 is provided near the proximal end of the main body 14.
  • this control panel region 60 comprises a digital display 80 along with a plurality of human interface elements that can be manipulated by a user to set and inject a combined dose.
  • the control panel region comprises a first dose setting button 62, a second dose setting button 64 and a third button 66 designated with the symbol ⁇ ."
  • an injection button 74 is also provided (not visible in the perspective view of Fig. 1 ).
  • the user interface of the drug delivery device may comprise additional buttons, such as a "menu” button, a "back” button, or a "light” button to switch on an illumination of the display.
  • the cartridge holder 40 can be removably attached to the main body 14 and may contain at least two cartridge retainers 50 and 52. Each retainer is configured so as to contain one medicament reservoir, such as a glass cartridge. Preferably, each cartridge contains a different medicament.
  • the drug delivery device illustrated in Fig. 1 includes a dispense interface 200.
  • this dispense interface 200 includes a main outer body 212 that is removably attached to a distal end 42 of the cartridge housing 40.
  • a distal end 214 of the dispense interface 200 preferably comprises a needle hub 216.
  • This needle hub 216 may be configured so as to allow a dose dispenser, such as a conventional pen type injection needle assembly, to be removably mounted to the drug delivery device 10.
  • the digital display 80 shown in Fig. 1 illuminates and provides the user certain device information, preferably information relating to the medicaments contained within the cartridge holder 40.
  • the user is provided with certain information relating to both the primary medicament (Drug A) and the secondary medicament (Drug B).
  • the first and second cartridge retainers 50, 52 may be hinged cartridge retainers. These hinged retainers allow user access to the cartridges.
  • Fig. 3 illustrates a perspective view of the cartridge holder 40 illustrated in Fig. 1 with the first hinged cartridge retainer 50 in an open position.
  • Fig. 3 illustrates how a user might access the first cartridge 90 by opening up the first retainer 50 and thereby having access to the first cartridge 90.
  • a dispense interface 200 can be coupled to the distal end of the cartridge holder 40.
  • Fig. 4 illustrates a flat view of the dispense interface 200 unconnected to the distal end of the cartridge holder 40.
  • a dose dispenser or needle assembly 400 that may be used with the interface 200 is also illustrated and is provided in a protective outer cap 420.
  • dispense interface 200 illustrated in Fig. 4 is shown coupled to the cartridge holder 40.
  • the axial attachment means 48 between the dispense interface 200 and the cartridge holder 40 can be any known axial attachment means to those skilled in the art, including snap locks, snap fits, snap rings, keyed slots, and combinations of such
  • connection or attachment between the dispense interface and the cartridge holder may also contain additional features (not shown), such as connectors, stops, splines, ribs, grooves, pips, clips and the like design features, that ensure that specific hubs are attachable only to matching drug delivery devices. Such additional features would prevent the insertion of a non-appropriate secondary cartridge to a non-matching injection device.
  • Fig. 5 also illustrates the needle assembly 400 and protective cover 420 coupled to the distal end of the dispense interface 200 that may be screwed onto the needle hub of the interface 200.
  • Fig. 6 illustrates a cross sectional view of the double ended needle assembly 400 mounted on the dispense interface 200 in Fig. 5.
  • the 6 comprises a double ended needle 406 and a hub 401 .
  • the double ended needle or cannula 406 is fixedly mounted in a needle hub 401.
  • This needle hub 401 comprises a circular disk shaped element which has along its periphery a circumferential depending sleeve 403.
  • a thread 404 is provided along an inner wall of this hub member 401 . This thread 404 allows the needle hub 401 to be screwed onto the dispense interface 200 which, in one preferred arrangement, is provided with a
  • a double ended needle 406 is mounted centrally through the protrusion 402 and the needle hub 401 .
  • This double ended needle 406 is mounted such that a first or distal piercing end 405 of the double ended needle forms an injecting part for piercing an injection site (e.g., the skin of a user).
  • a second or proximal piercing end 408 of the needle assembly 400 protrudes from an opposite side of the circular disc so that it is concentrically surrounded by the sleeve 403.
  • the second or proximal piercing end 408 may be shorter than the sleeve 403 so that this sleeve to some extent protects the pointed end of the back sleeve.
  • the needle cover cap 420 illustrated in Fig. 4 and 5 provides a form fit around the outer surface 403 of the hub 401. Referring now to Fig. 4 to 1 1 , one preferred arrangement of this interface 200 will now be discussed. In this one preferred arrangement, this interface 200 comprises:
  • valve seal 260 f. a valve seal 260, and g. a septum 270.
  • the main outer body 210 comprises a main body proximal end 212 and a main body distal end 214.
  • a connecting member is configured so as to allow the dispense interface 200 to be attached to the distal end of the cartridge holder 40.
  • the connecting member is configured so as to allow the dispense interface 200 to be removably connected the cartridge holder 40.
  • the proximal end of the interface 200 is configured with an upwardly extending wall 218 having at least one recess.
  • the upwardly extending wall 218 comprises at least a first recess 217 and a second recess 219.
  • the first and the second recesses 217, 219 are positioned within this main outer body wall so as to cooperate with an outwardly protruding member located near the distal end of the cartridge housing 40 of the drug delivery device 10.
  • this outwardly protruding member 48 of the cartridge housing may be seen in Fig. 4 and 5.
  • a second similar protruding member is provided on the opposite side of the cartridge housing.
  • the outwardly protruding members will cooperate with the first and second recess 217, 219 to form an interference fit, form fit, or snap lock.
  • any other similar connection mechanism that allows for the dispense interface and the cartridge housing 40 to be axially coupled could be used as well.
  • the main outer body 210 and the distal end of the cartridge holder 40 act to form an axially engaging snap lock or snap fit arrangement that could be axially slid onto the distal end of the cartridge housing.
  • the dispense interface 200 may be provided with a coding feature so as to prevent inadvertent dispense interface cross use. That is, the inner body of the hub could be geometrically configured so as to prevent an inadvertent cross use of one or more dispense interfaces.
  • a mounting hub is provided at a distal end of the main outer body 210 of the dispense interface 200. Such a mounting hub can be configured to be releasably connected to a needle assembly.
  • this connecting means 216 may comprise an outer thread that engages an inner thread provided along an inner wall surface of a needle hub of a needle assembly, such as the needle assembly 400 illustrated in Fig. 6.
  • Alternative releasable connectors may also be provided such as a snap lock, a snap lock released through threads, a bayonet lock, a form fit, or other similar connection arrangements.
  • the dispense interface 200 further comprises a first inner body 220. Certain details of this inner body are illustrated in Fig. 8-1 1.
  • this first inner body 220 is coupled to an inner surface 215 of the extending wall 218 of the main outer body 210.
  • this first inner body 220 is coupled by way of a rib and groove form fit arrangement to an inner surface of the outer body 210.
  • the extending wall 218 of the main outer body 210 is provided with a first rib 213a and a second rib 213b.
  • This first rib 213a is also illustrated in Fig. 10.
  • These ribs 213a and 213b are positioned along the inner surface 215 of the wall 218 of the outer body 210 and create a form fit or snap lock engagement with cooperating grooves 224a and 224b of the first inner body 220.
  • these cooperating grooves 224a and 224b are provided along an outer surface 222 of the first inner body 220.
  • a proximal surface 226 near the proximal end of the first inner body 220 may be configured with at least a first proximally positioned piercing needle 240 comprising a proximal piercing end portion 244.
  • the first inner body 220 is configured with a second proximally positioned piercing needle 250 comprising a proximally piercing end portion 254.
  • Both the first and second needles 240, 250 are rigidly mounted on the proximal surface 226 of the first inner body 220.
  • this dispense interface 200 further comprises a valve arrangement.
  • Such a valve arrangement could be constructed so as to prevent cross contamination of the first and second medicaments contained in the first and second reservoirs, respectively.
  • a preferred valve arrangement may also be configured so as to prevent back flow and cross
  • dispense interface 200 includes a valve arrangement in the form of a valve seal 260.
  • a valve seal 260 may be provided within a cavity 231 defined by the second inner body 230, so as to form a holding chamber 280.
  • cavity 231 resides along an upper surface of the second inner body 230.
  • This valve seal comprises an upper surface that defines both a first fluid groove 264 and second fluid groove 266.
  • Fig. 9 illustrates the position of the valve seal 260, seated between the first inner body 220 and the second inner body 230.
  • this seal valve 260 helps to prevent the primary medicament in the first pathway from migrating to the secondary medicament in the second pathway, while also preventing the secondary medicament in the second pathway from migrating to the primary medicament in the first pathway.
  • this seal valve 260 comprises a first non-return valve 262 and a second non-return valve 268.
  • the first non-return valve 262 prevents fluid transferring along the first fluid pathway 264, for example a groove in the seal valve 260, from returning back into this pathway 264.
  • the second non-return valve 268 prevents fluid transferring along the second fluid pathway 266 from returning back into this pathway 266.
  • This holding chamber 280 is defined by an inner chamber defined by a distal end of the second inner body both the first and the second non return valves 262, 268 along with a pierceable septum 270. As illustrated, this pierceable septum 270 is positioned between a distal end portion of the second inner body 230 and an inner surface defined by the needle hub of the main outer body 210.
  • the holding chamber 280 terminates at an outlet port of the interface 200.
  • This outlet port 290 is preferably centrally located in the needle hub of the interface 200 and assists in maintaining the pierceable seal 270 in a stationary position.
  • the output fluid path allows both medicaments to be in fluid communication with the attached needle assembly.
  • the hub interface 200 further comprises a second inner body 230. As can be seen from Fig. 9, this second inner body 230 has an upper surface that defines a recess, and the valve seal 260 is positioned within this recess. Therefore, when the interface 200 is assembled as shown in Fig.
  • the second inner body 230 will be positioned between a distal end of the outer body 210 and the first inner body 220. Together, second inner body 230 and the main outer body hold the septum 270 in place.
  • the distal end of the inner body 230 may also form a cavity or holding chamber that can be configured to be fluid communication with both the first groove 264 and the second groove 266 of the valve seal.
  • Fig. 1 1 illustrates the dispense interface 200 after it has been mounted onto the distal end 42 of the cartridge holder 40 of the drug delivery device 10 illustrated in Fig. 1.
  • a double ended needle 400 is also mounted to the distal end of this interface.
  • the cartridge holder 40 is illustrated as having a first cartridge containing a first medicament and a second cartridge containing a second medicament.
  • the proximal piercing end 244 of the first piercing needle 240 pierces the septum of the first cartridge 90 and thereby resides in fluid communication with the primary medicament 92 of the first cartridge 90.
  • a distal end of the first piercing needle 240 will also be in fluid communication with a first fluid path groove 264 defined by the valve seal 260.
  • the proximal piercing end 254 of the second piercing needle 250 pierces the septum of the second cartridge 100 and thereby resides in fluid communication with the secondary medicament 102 of the second cartridge 100.
  • a distal end of this second piercing needle 250 will also be in fluid communication with a second fluid path groove 266 defined by the valve seal 260.
  • Fig. 1 1 illustrates a preferred arrangement of such a dispense interface 200 that is coupled to a distal end 15 of the main body 14 of drug delivery device 10.
  • a dispense interface 200 is removably coupled to the cartridge holder 40 of the drug delivery device 10.
  • the dispense interface 200 is coupled to the distal end of a cartridge housing 40.
  • This cartridge holder 40 is illustrated as containing the first cartridge 90 containing the primary medicament 92 and the second cartridge 100 containing the secondary medicament 102.
  • the dispense interface 200 essentially provides a mechanism for providing a fluid communication path from the first and second cartridges 90, 100 to the common holding chamber 280.
  • This holding chamber 280 is illustrated as being in fluid communication with a dose dispenser.
  • this dose dispenser comprises the double ended needle assembly 400.
  • the proximal end of the double ended needle assembly is in fluid
  • the dispense interface is configured so that it attaches to the main body in only one orientation, that is it is fitted only one way round.
  • the primary needle 240 can only be used for fluid communication with the primary medicament 92 of the first cartridge 90 and the interface 200 would be prevented from being reattached to the holder 40 so that the primary needle 240 could now be used for fluid communication with the secondary medicament 102 of the second cartridge 100.
  • Such a one way around connecting mechanism may help to reduce potential cross contamination between the two medicaments 92 and 102.
  • Figure 12 shows a perspective view of an alternative embodiment of the delivery device shown in Fig. 1 .
  • the delivery device shown in Fig. 12 differs from the delivery device in Fig. 1 in that the device further comprises a sensor 502 to detect whether end cap 18 is attached to the distal end 15 of main body 14. Cap 18 here constitutes to a detachable element and the distal end 15 acts as the coupling portion for attaching thereto the detachable element.
  • the delivery device shown in Fig. 12 furthermore comprises door opening buttons 504, 506 for opening cartridge retainers 50, 52.
  • Sensor 502 may be for example a reed or hall sensor and the cap 18 may comprise a corresponding magnet 508 which creates a magnetic field that is detected by sensor 502 when cap 18 is properly attached to the device.
  • Magnet 508 may for example be embedded into the cap material as illustrated in Fig. 12.
  • Sensor 502 is therewith configured to detect attachment or detachment of cap 18 to or from the distal end 15 of the main body 14.
  • the device shown in Fig. 12 has a plurality of human interface elements such as in particular first dose setting button 62, second dose setting button 64, an ⁇ " button 66 and buttons 504, 506 and a return button (not shown) to go back one step in almost all situation and a injection button 74 to start and stop / pause the injection and a sound button (not shown) to choose between 4 sound volume level.
  • These buttons all constitute input elements of the device being actuatable by a user action, namely by pressing the respective buttons.
  • sensor 502 may constitute an input element which the user may actuate by attaching or detaching cap 18 to or from distal end 50.
  • Digital display 80 of the delivery device constitutes an output interface for outputting messages to a user, in particular text and/or graphical messages.
  • the user is usually requested to select a language for the messages to be displayed on digital display 80 during operation of the device.
  • the device offers a possibility to reset the language during a language setting or resetting step. Since the delivery device in Fig. 12 only has a limited number of input elements, there is no particular input element exclusively available to trigger the language setting or resetting step. Moreover, the language setting step shall not be triggered inadvertently during regular operation of the apparatus. Therefore, the control unit of the delivery device in Fig. 12 is configured to perform the language setting or resetting step upon detection of a predefined user input, the predefined user input comprising actuation of at least two of the input elements of the device.
  • Fig. 13 shows a flow chart for detection of predefined user input by the control unit of the device in Fig. 12.
  • the predefined user input may be performed from any state or operation of the delivery device (step 602). However, it may be advantageous to exclude some status or operations, such as during an injection or during a motor movement. During such a status or operation it is then not possible for the user to trigger the language setting or resetting step by performing the predefined user input.
  • the predefined user input may comprise the following in the given order:
  • cap 18 is detached from the delivery device
  • injection button 74 is pressed and hold down by the user
  • buttons 62 and 74 are hold down together for a minimum time of at least 400 ms before the user releases said buttons.
  • the device then continues to the language setting or resetting step or enters the language change function. At this time, the device may generate a confirmation tone or sound.
  • the control unit From the initial state 602 the control unit first determines by sensor 502 whether the cap 18 is attached to the distal end 15 and whether button 62 is pressed and held down by the user (step 604). If this is the case, the control unit then determines by means of sensor 502 whether the user removes the cap while still holding down button 62 (step 606). If this is the case, the control unit then determines whether the user presses ejection button 74 while still holding down button 62 (step 608). If this is the case, the control unit detects whether buttons 62 and 74 are hold down together for a time period of at least 400 ms before the buttons 62 and 74 are released (step 610). If this is also the case, the control unit has detected the predefined user input and therefore performs the language setting or resetting step (step 612).
  • control unit If at any of steps 604, 606, 608 and 610 the control unit detects that one of the respective conditions is not fulfilled, the control unit returns to the initial state 602, so that the user would have to perform the predefined user input from the start for triggering the language setting step.
  • one of the door opening buttons 504, 506 may have to be pressed in step 608 instead of the ejection button 74.
  • predefined user input being a complex sequence as the sequence described above, it is very unlikely that the predefined user input is performed inadvertently, i.e. when the user does not intend to perform the language setting step. However, such a predefined user input is still simple enough to be remembered and performed by a user.
  • Figure 14 shows a flow chart of an exemplary language setting step, such as the language setting or resetting step 612 triggered by the predefined user input described above.
  • the language setting step starts in step 702.
  • the control unit causes digital display 80 to display a menu with several languages as menu items such as "English”, “Deutsch”, “Frangais” etc. each language menu item in its own language.
  • the current selection of the language i.e. the language corresponding to the current value of the message language setup variable is highlighted, for example by underlining, or by bold type. For example, if the message language setup variable is numeric and "1 " corresponds to "English”, “2” corresponds to "German” and "3" corresponds to "French", the menu item "German” is highlighted if the value of the message language setup variable equals "2".
  • step 706 the control unit determines whether the user presses a particular button of the delivery device. If the user presses "UP” button 62 or "DOWN” button 64, control unit continues with step 708, in which it changes the value of the message language setup variable accordingly. For example, the control unit may increase a numeric message language setup variable by "1 " if the user has pressed “UP” button 62, and decrease it by “1 “ if the user has pressed “DOWN” button 64. The control unit then continues with step 704 and again displays the menu in which now a different language is highlighted.
  • control unit ends the language setting step (step 710), so that the value of the message language setup variable keeps the value previously selected by the user during the language setting step.
  • drug or “medicament”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further
  • Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl- des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N- lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(oo-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(oo-
  • Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H His-Gly-Glu- Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-lle-Glu- Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
  • Exendin-4 derivatives are for example selected from the following list of compounds: H-(Lys)4-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,
  • Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
  • Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Goserelin.
  • a polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof.
  • An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • Antibodies are globular plasma proteins (-150 kDa) that are also known as immunoglobulins which share a basic structure.
  • each antibody As they have sugar chains added to amino acid residues, they are glycoproteins.
  • the basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.
  • Ig immunoglobulin
  • the Ig monomer is a "Y"-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-1 10 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two ⁇ sheets create a "sandwich" shape, held together by interactions between conserved cysteines and other charged amino acids.
  • Ig heavy chain There are five types of mammalian Ig heavy chain denoted by ⁇ , ⁇ , ⁇ , ⁇ , and ⁇ .
  • the type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
  • Distinct heavy chains differ in size and composition; a and ⁇ contain approximately 450 amino acids and ⁇ approximately 500 amino acids, while ⁇ and ⁇ have approximately 550 amino acids.
  • Each heavy chain has two regions, the constant region (CH) and the variable region (VH).
  • the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes.
  • Heavy chains ⁇ , a and ⁇ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains ⁇ and ⁇ have a constant region composed of four immunoglobulin domains.
  • the variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone.
  • the variable region of each heavy chain is approximately 1 10 amino acids long and is composed of a single Ig domain.
  • a light chain has two successive domains: one constant domain (CL) and one variable domain (VL).
  • CL constant domain
  • VL variable domain
  • the approximate length of a light chain is 21 1 to 217 amino acids.
  • Each antibody contains two light chains that are always identical; only one type of light chain, ⁇ or ⁇ , is present per antibody in mammals.
  • variable (V) regions are responsible for binding to the antigen, i.e. for its antigen specificity.
  • VL variable light
  • VH variable heavy chain
  • CDRs Complementarity Determining Regions
  • an "antibody fragment” contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from.
  • Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab).
  • the Fc contains carbohydrates, complement-binding, and FcR-binding sites.
  • F(ab')2 is divalent for antigen binding.
  • the disulfide bond of F(ab')2 may be cleaved in order to obtain Fab'.
  • the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv).
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • Acid addition salts are e.g. HCI or HBr salts.
  • Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1 )(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6- C10-aryl group, or an optionally substituted C6-C10-heteroaryl group.
  • solvates are for example hydrates.

Abstract

The invention relates to a medical apparatus, in particular for ejecting a fluid, having a user interface for outputting messages, having at least two input elements, having a control unit for controlling the apparatus as a function of a user input by means of the input elements, and having a storage for storing a message language setup variable, wherein the control unit is configured to perform a language setting or resetting step, during which the value of the message language setup variable is selected as a function of a user input, wherein the control unit is configured to select the language of messages to be output as a function of the message language setup variable, and wherein the control unit is further configured to perform the language setting or resetting step upon detection of a predefined user input, the predefined user input comprising actuation of at least two of the input elements.

Description

Description
Apparatus with language reset feature and method for controlling such an apparatus
The invention relates to an apparatus having a language setting feature. In particular, the invention relates to a medical device or apparatus, such as an injection device or an analyte measurement device (e.g. a glucose meter) which allows a first set language to be reset at a later time.
The device or apparatus may have a user interface for outputting messages to a user, having at least two input elements, each input element being actuatable by a user action, having a control unit for controlling the apparatus as a function of a user input by means of the input elements, and having a storage for storing a message language setup variable, wherein the control unit is configured to perform a language setting step, during which the value of the message language setup variable is selected as a function of a user input, and wherein the control unit is configured to select the language of messages to be output by means of the user interface as a function of a message language setup variable. For example, the apparatus may be a medical device, in particular a medicament injection device.
The medical device or apparatus can be an injector, for example a hand-held injector, especially a pen-type injector, that is an injector of the kind that provides for administration by injection of medicinal products from one or more multidose cartridges. In particular, the present invention relates to such injectors where a user may set the dose.
The drug agents may be contained in two or more multiple dose reservoirs, containers or packages, each containing independent (single drug compound) or pre-mixed (co-formulated multiple drug compounds) drug agents.
Certain disease states require treatment using one or more different medicaments. Some drug compounds need to be delivered in a specific relationship with each other in order to deliver the optimum therapeutic dose. The present patent application is of particular benefit where combination therapy is desirable, but not possible in a single formulation for reasons such as, but not limited to, stability, compromised therapeutic performance and toxicology. For example, in some cases it may be beneficial to treat a diabetic with a long acting insulin (also may be referred to as the first or primary medicament) along with a glucagon-like peptide-1 such as GLP-1 or GLP-1 analog (also may be referred to as the second drug or secondary medicament).
Accordingly, there exists a need to provide devices for the delivery of two or more
medicaments in a single injection or delivery step that is simple for the user to perform without complicated physical manipulations of the drug delivery device. The proposed drug delivery device provides separate storage containers or cartridge retainers for two or more active drug agents. These active drug agents are then combined and/or delivered to the patient during a single delivery procedure. These active agents may be administered together in a combined dose or alternatively, these active agents may be combined in a sequential manner, one after the other. The drug delivery device also allows for the opportunity of varying the quantity of the medicaments. For example, one fluid quantity can be varied by changing the properties of the injection device (e.g., setting a user variable dose or changing the device's "fixed" dose). The second medicament quantity can be changed by manufacturing a variety of secondary drug containing packages with each variant containing a different volume and/or
concentration of the second active agent.
The drug delivery device may have a single dispense interface. This interface may be configured for fluid communication with a primary reservoir and with a secondary reservoir of medicament containing at least one drug agent. The drug dispense interface can be a type of outlet that allows the two or more medicaments to exit the system and be delivered to the patient.
The combination of compounds from separate reservoirs can be delivered to the body via a double-ended needle assembly. This provides a combination drug injection system that, from a user's perspective, achieves drug delivery in a manner that closely matches the currently available injection devices that use standard needle assemblies. One possible delivery procedure may involve the following steps:
1 . Attach a dispense interface to a distal end of the electro-mechanical injection device. The dispense interface comprises a first and a second proximal needle. The first and second needles pierce a first reservoir containing a primary compound and a second reservoir containing a secondary compound, respectively. 2. Attach a dose dispenser, such as a double-ended needle assembly, to a distal end of the dispense interface. In this manner, a proximal end of the needle assembly is in fluidic communication with both the primary compound and secondary compound.
3. Dial up/set a desired dose of the primary compound from the injection device, for example, via a graphical user interface (GUI).
4. After the user sets the dose of the primary compound, the micro-processor controlled control unit may determine or compute a dose of the secondary compound and preferably may determine or compute this second dose based on a previously stored therapeutic dose profile. It is this computed combination of medicaments that will then be injected by the user. The therapeutic dose profile may be user selectable. Alternatively, the user can dial or set a desired dose of the secondary compound.
5. Optionally, after the second dose has been set, the device may be placed in an armed condition. The optional armed condition may be achieved by pressing and/or holding an ΌΚ" or an "Arm" button on a control panel. The armed condition may be provided for a predefined period of time during which the device can be used to dispense the combined dose.
6. Then, the user will insert or apply the distal end of the dose dispenser (e.g. a double ended needle assembly) into the desired injection site. The dose of the combination of the primary compound and the secondary compound (and potentially a third medicament) is administered by activating an injection user interface (e.g. an injection button).
Both medicaments may be delivered via one injection needle or dose dispenser and in one injection step. This offers a convenient benefit to the user in terms of reduced user steps compared to administering two separate injections.
Complex devices such as the drug delivery device described above, analyte measurement devices such as glucose meter, and / or the like, usually comprise user interfaces by means of which the device outputs messages to the user to inform him about the device operation status, to offer him a selection of possible operation steps, to request a particular operation step to be performed by the user, and / or the like. Since those devices are usually sold in more than one country or in countries with more than one official language, many devices have the capability to prompt these messages in different languages. For example, some devices perform a language setting step when the device is powered up for the first time, during which the user may select his preferred language from a language selection menu. The device may then be configured to output messages in the language selected by the user during the language setting step. Alternatively, the language may also be preselected by the manufacturer or by the vendor of the device. If the device is for example intended to be sold in Germany, the vendor may preselect the language "German" for the device.
Devices that are capable of outputting messages in different languages are advantageous in that they may be sold in different countries without the need of providing it with new software that is adapted to a particular language.
Problems with such devices may however occur if for example the user inadvertently selects the wrong language during first use of the device or if the wrong language was already preset by the manufacturer or by the vendor. Also in case of a software error, the language of the device may be set incorrectly.
Even if the language was preset correctly by the manufacturer or vendor for a particular country in which the device was sold, for example "German" for an apparatus sold in Germany, some users may still prefer a different language over the preselected language such as for example French people living in Germany preferring the French language over German.
In all these scenarios, it would be desirable for the user to be able to change the language selection of the device. Devices such as the medicament injection device described above however only have a very limited number of input elements such as buttons or the like due to the limited size of the device or production cost limitations or in order not to overload and complicate the device with a vast number of input elements, which would otherwise render them difficult to operate for the user. Therefore, it is often not possible to designate a particular button of the device for triggering a language setting step to select another language. Moreover, the selection of another language ought to be necessary only once or twice during the whole life time of the device and many users will probably never need it. Therefore, it is undesirable to occupy a specific one of the limited number of input elements to perform a language selection which then would not be available for other operational steps that occur more frequently. It is also undesirable if the language selection may easily be triggered inadvertently during regular operation of the apparatus, for example by the user inadvertently pressing a particular button.
In light of the aforementioned, it is inter alia an object of the present invention to provide an apparatus such as a medical device for example for ejecting a fluid, which provides the possibility to reset the language of the messages output on a user interface, in particular without interfering the regular operation of the apparatus. An object of the present invention is also to provide a method for controlling such an apparatus. These objects are at least in part solved by an apparatus, in particular a medical device, such as a device for ejecting a fluid, measuring analyte data etc., having a user interface for outputting messages to a user, having at least two input elements, each input element being actuatable by a user action, having a control unit configured to control the apparatus, for example based at least in part on a user input by means of the input elements, and having a storage for storing a message language setup variable, wherein the control unit is configured to perform a language setting step, during which a value of the message language setup variable is selected as a function of a user input, wherein the control unit is configured to select the language of messages to be output by means of the user interface as a function of the message language setup variable, and wherein the control unit is further configured to perform the language setting step upon detection of a predefined user input, the predefined user input comprising actuation of at least two of the input elements.
These objects are also at least in part solved by a method for controlling such an apparatus comprising the steps of: performing a language setting step, during which the value of a message language setup variable is selected as a function of the user input; and outputting messages on a user interface, wherein the language of the messages is selected as a function of the message language setup variable, wherein the language setting step is performed upon detection of a predefined user input, the predefined user input comprising actuation of at least two input elements.
The apparatus may be a delivery device, especially a drug delivery device such as a medical device configured to eject a drug agent (e.g. a dose of a medicament) such as an infusion device or an injection device, for instance an insulin injection pen. Injection devices may be used either by medical personnel or by patients themselves. As an example, type-1 and type-2 diabetes may be treated with patients themselves by injection of insulin doses for example once or several times per day.
In particular, the apparatus may be a medical device configured to deliver (i.e. eject) at least two drug agents from separate cartridges situated in two separate retainers.
Alternatively, the apparatus may for instance be configured to deliver (i.e. eject) a two- component adhesive from separate cartridges comprising a first component of the two- component adhesive (i.e. a binder) and a second component of the two-component adhesive (i.e. a hardener) respectively.
The apparatus has a user interface for outputting messages to a user. The user interface may in particular comprise a display such as an LCD or TFT display to present messages containing text and/or graphic pictograms or the like to a user. Alternatively, or in addition to that, the user interface may also comprise a speaker to output a sound, in particular a voice message. The apparatus has at least two input elements, each input element being actuatable by a user action. Such an input element may for example be a button like as a push button, a slide button or a rotary button that may be actuated by the user by pressing, sliding or turning the button. Such a button may also be actuated by holding the button for a predefined time such as holding down a push button, holding displaced a slide button or holding rotated a rotary button for a predefined time. A user input element may also be a sensor such as an optical sensor, a magnetic sensor, a mechanical sensor, in particular a proximity sensor or an acceleration sensor or the like. Such a sensor may be configured to be activatable by a particular user action. For example, the sensor may be configured to detect whether the user manipulates, attaches or detaches a component of the apparatus such as for example a cap.
The apparatus comprises a control unit for controlling the apparatus. The control unit is preferably a micro-processor control unit comprising a micro-processor and a storage containing commands for controlling the apparatus. The control unit is configured to control the apparatus as a function of user input by means of the input elements. This is understood to mean, that the control units is configured such that at least some steps performed by the control unit to control the apparatus are a function of user input by means of the input elements. The control unit may be configured such that a particular control step is performed if the user activates a particular input element. For example, if the apparatus is a medicament injection device, medicament ejection may be triggered by the control unit if a user presses a particular ejection button of the device. The apparatus has a storage for storing a message language setup variable. The storage may for example be a RAM, a ROM, a flash memory, a hard disk or the like. The value of the message language setup variable indicates a selected language of the apparatus or indicates that no language has been selected yet. For example, the message language setup variable may be a variable of numerical type, such as an integer type, wherein a particular number value of the variable is attributed to a particular language, such as "0" for "no language selected", "1 " for English, "2" for German, "3" for French etc. Alternatively the language setup variable may also be of a string type, wherein a particular string value of the variable is again attributed to a particular language, such as "NN" for "no language selected", "EN" for English, "DE" for German, "FR" for French etc. Other implementations of the message language setup variable are of course possible as well.
The control unit is configured to perform a language setting step, during which the value of the message language setup variable is selected as a function of a user input. Such a step is often performed on the first use of an apparatus, so that the user may select his preferred language on the first use. Alternatively, such a language setting step may also be performed with the manufacturer or vendor to preselect a language.
During the language setting step the user may for example select one of a number of languages from a menu by actuating particular buttons of the apparatus. For example, the apparatus may comprise an "UP" and a "DOWN" button to navigate within a language selection menu and an "OK" button to confirm a language that is currently selected in the menu. The control unit is configured to set the value of the message language setup variable as a function of the user input, for example to "DE" or "2" if the user selects "German" during the language setting setup.
The control unit is configured to select the language of messages to be output by means of the user interface as a function of the message language setup variable. If for example the user interface comprises a display for outputting text messages to the user, the control unit may be configured to select from a number of messages stored in a storage a message with the appropriate content and with the language according to the value of the message language setup variable. To this end, the storage may contain messages with a particular content such as "Press OK for confirmation" in different languages. Accordingly, if the user interface comprises a speaker, the storage may contain voice messages with a particular content in different languages so that the control unit may select a voice message with the appropriate content and with the selected language and output the message by means of the speaker.
The control unit is configured to perform the language setting or resetting step upon detection of a predefined user input, the predefined user input comprising actuation of at least two of the input elements. Actuation of at least two of the input elements means that the user has to actuate at least a first and a second input element during a single user input, for example by simultaneously and/or sequentially actuating the at least two input elements. For example, the predefined user input may comprise simultaneous actuation of a first and of a second button of the device.
A single user input means that actuation of the at least two input elements triggers one particular step controlled by the control unit, presently the language setting or resetting step. In contrast to that, sequential actuation of input elements wherein each actuation causes a step controlled by the control unit is not regarded as a predefined user input comprising actuation of at least two of the input elements but rather as multiple user inputs. For example, navigation in a menu by pressing "UP" and "DOWN" buttons several times is not regarded as a predefined user input comprising actuation of at least two of the input elements since after each single actuation of either the "UP" or "DOWN" button the control unit controls another menu item to be selected.
The apparatus described above allows a user to select a different language for the messages output on the user interface during regular operation of the apparatus, i.e. after the language setup variable has already been set, for example during a language setting step performed on first use.
As the predefined user input comprises actuation of at least two of the input elements, the apparatus does not have to be equipped with an additional button to trigger the language setting step. In particular, the predefined user input does not occupy the original function of the at least two of the input elements, as these input elements may still be configured for another function when pressed alone or at least independently from the predefined user input. For example, actuation of only one of the at least two of the input elements may cause a step to be performed that occurs more frequently during normal operation of the apparatus. The language setting step is only performed if both of these at least two of the input elements are actuated according to the predefined user input. This control takes into account that apparatuses usually only comprise a limited number of input elements.
Furthermore, by triggering the language setting or resetting step with such a complex predefined user input comprising actuation of more than one input element, it is less likely that the language setting or resetting step is triggered by an inadvertent user input.
An inadvertent triggering of the language setting or resetting step may be rendered even less likely if the apparatus comprises more than two, for example at least three or at least four input elements, and if the predefined user input comprises actuation of more than two, for example at least three or at least four of the input elements.
A number of embodiments of the apparatus and of the method will be described in the following. Although these embodiments are described in particular with reference to the apparatus, they are not limited to the apparatus, but also apply accordingly for the method for controlling such an apparatus.
According to a first embodiment of the apparatus the predefined user input comprises sequential actuation of at least two of the input elements. This is understood to mean that the user first has to actuate a first input element and subsequently a second input element in order to trigger the language setting step to be performed. The predefined user input may in particular comprise sequential actuation of at least two input elements within a predefined maximum time interval. By defining a maximum time interval for the sequence of input element actuation the control unit may distinguish between the predefined user input and multiple user inputs in which the user individually actuates these input elements. For example the user may have to press a first button and then a second button within 1 s after pressing the first button in order to trigger the language setting step to be performed. If he presses the second button more than 1 s after pressing the first button, the control unit will detect two separate user inputs.
Such a sequential actuation in particular within a maximum time interval is less likely to be performed inadvertently by the user. Moreover, the two input elements may trigger different control steps to be performed if actuated alone or with a time difference longer than a predefined maximum time interval.
According to a further embodiment of the apparatus the predefined user input comprises actuation of a first input element and subsequent actuation of a second input element while still actuating the first input element. For example, the predefined user input may comprise pressing and holding down a first button and then actuating another input element, while still holding down the first button. Actuation of one input element while at the same time still actuating another input element will often require the user to operate the apparatus with both hands. It is therefore very unlikely that the user triggers the language setup step when operating the apparatus with one hand only. This embodiment is therefore in particular advantageous for apparatuses such as medical injection devices which are designed to be operated during normal operation with one hand only. The predefined user input may in particular comprise actuation of two input elements which are located remote from each other, for example on two different sides of the apparatus. This increases the likelihood that a user needs two hands to actuate both of the input elements so that unintentional actuation of both elements is unlikely. According to a further embodiment of the apparatus, the predefined user input comprises actuation of at least one input element for a predefined time period. For example the predefined user input may comprise actuation of a button for a predefined time period such as pressing and holding down the button for a predefined time period such as for example at least 400 ms.
According to a further embodiment of the apparatus, the apparatus comprises a coupling portion for attaching thereto a detachable element and an input element configured as a sensor to detect attachment or detachment of the detachable element, and wherein the predefined user input comprises attaching of the detachable element to the coupling portion and/or detaching the detachable element from the coupling portion.
For example, the apparatus may comprise a coupling portion for attaching thereto a cap to protect parts of the apparatus when not in use. The apparatus may furthermore comprise a sensor like an optical or magnetic sensor to determine whether the cap is attached to the coupling portion or not. Attachment or detachment of the cap may then be regarded as user action to actuate the sensor, the sensor constituting the input element. For example, the predefined user input may comprise pressing a first button of the apparatus and then detaching the cap from the apparatus while still holding down the first button. This embodiment allows rather complex input sequences for triggering the language setting step which are still easy to remember and to perform by the user but nearly impossible to be performed inadvertently. According to a further embodiment the apparatus comprises a portion being movable relative to the apparatus by rotation and/or translation and an input element configured as a sensor to detect movement of said portion, and wherein the predefined user input comprises moving said portion. For example, said portion may be a cover or door part movable between an open and a closed position for accessing a component within the apparatus such as a medicament cartridge within a medicament injection device. The apparatus may for example comprise a hinge or a guide track for moving a cover or door part. A sensor provided for detecting movement of said portion may be used as input element that is actuated by the user moving the portion, in particular as part of a predefined user input for triggering the language setting step.
This embodiment as well allows complex user input sequences to be defined as predefined user input for triggering the language setting or resetting step which are easy to remember and to perform by the user but unlikely to be performed inadvertently.
According to a further embodiment of the apparatus, the predefined user input comprises the following, preferably in the given order:
pressing and holding a first button,
- detaching or attaching a detachable element,
pressing and holding a second button,
holding the first and second button for a predefined time, and
releasing the first and second button. It was found that with such a complex sequence used as the predefined user input to trigger the language resetting step it is nearly impossible that the language resetting step is triggered inadvertently. However, the sequence is still easy enough to be remembered and to be performed by the user to intentionally initiate the language setting step. According to a further embodiment of the apparatus, the storage is configured to store user operation related data in at least one user operation data variable and wherein the control unit it is configured to maintain the value of the at least one user operation data variable during the control sequence performed upon detection of the predefined user input. User operation related data is understood to designate data, which is directly connected to the use of the apparatus by the user. Such user operation related data may in particular include data that is used by risk mitigation functions of the apparatus such as by a function tracking the total operation time of the apparatus or by a function monitoring medicament cartridge expiring. Moreover, the user operation related data may also include data with specific user-related information such as the daily bolus, the user's name, age or weight or the like.
Sometimes, the language of the apparatus may also be reset by means of a hard reset, during which the apparatus is reset to the original factory settings. The first use of the apparatus after a hard reset is often similar to the original first use of the apparatus, so that an initial language selection may be possible. However, during a hard reset all user operation related data is deleted from the apparatus and thus lost. This may raise safety concerns, in particular for medical devices, as the further operation of the apparatus is no more adapted to the actual needs of the user.
The embodiment described above instead allows resetting the message language setup variable while at the same time maintaining the user operation related data. Thus, data which is important for a safe use of the device is unchanged after resetting the language.
According to a further embodiment of the apparatus, the control unit is configured to output a confirmation message, in particular a confirmation sound, upon detection of the predefined user input. In this way the user is informed when he has correctly performed the predefined user input to initiate the language resetting step. Furthermore, if the predefined user input was input inadvertently, the user is warned that the language resetting step has been triggered. According to a further embodiment of the apparatus, the apparatus is a medical device, in particular a medicament injection device. If a medical device is set to an incorrect language, the user may be hindered to use the device anymore or his security may even be at risk when he uses the device improperly because he does not understand the messages output on the user interface. The possibility of resetting the language therefore in particular improves the user safety of medical devices.
According to a further embodiment, the apparatus is hand-held. Hand-held apparatuses, in particular hand-held medical devices, are often use by a layman such as patients
themselves, who often have to rely on the messages displayed on the output interface in order to properly operate the device. The possibility of resetting the language is therefore in particular advantageous for such hand-held apparatuses. These as well as other advantages of various aspects of the present invention will become apparent to those of ordinary skill in the art by reading the following detailed description, with appropriate reference to the accompanying drawings, in which:
Fig. 1 illustrates a perspective view of a delivery device with an end cap of the
device removed;
Fig. 2 illustrates a perspective view of the delivery device distal end showing the cartridge;
Fig. 3 illustrates a perspective view of the delivery device illustrated in Fig. 1 or 2 with one cartridge retainer in an open position;
Fig. 4 illustrates a dispense interface and a dose dispenser that may be removably mounted on a distal end of the delivery device illustrated in Fig. 1 ;
Fig. 5 illustrates the dispense interface and the dose dispenser illustrated in Fig. 4 mounted on a distal end of the delivery device illustrated in Fig. 1 ;
Fig. 6 illustrates one arrangement of a needle assembly that may be mounted on a distal end of the delivery device;
Fig. 7 illustrates a perspective view of the dispense interface illustrated in Fig. 4;
Fig. 8 illustrates another perspective view of the dispense interface illustrated in Fig.
4;
Fig. 9 illustrates a cross-sectional view of the dispense interface illustrated in Fig. 4;
Fig. 10 illustrates an exploded view of the dispense interface illustrated in Fig. 4;
Fig. 1 1 illustrates a cross-sectional view of the dispense interface and needle
assembly mounted onto a drug delivery device, such as the device illustrated in Fig. 1 ;
Fig. 12 illustrates a perspective view of a delivery device comprising a sensor for detecting whether the cap is attached to the device or not; Fig. 13 shows a flow chart for detection of a predefined user input; and
Fig. 14 shows a flow chart of an exemplary language setting step.
The drug delivery device illustrated in Fig. 1 comprises a main body 14 that extends from a proximal end 16 to a distal end 15. At the distal end 15, a removable end cap or cover 18 is provided. This end cap 18 and the distal end 15 of the main body 14 work together to provide a snap fit or form fit connection so that once the cover 18 is slid onto the distal end 15 of the main body 14, this frictional fit between the cap and the main body outer surface 20 prevents the cover from inadvertently falling off the main body.
The main body 14 contains a micro-processor control unit, an electro-mechanical drive train, and at least two medicament reservoirs. When the end cap or cover 18 is removed from the device 10 (as illustrated in Fig. 1 ), a dispense interface 200 is mounted to the distal end 15 of the main body 14, and a dose dispenser (e.g., a needle assembly) is attached to the interface. The drug delivery device 10 can be used to administer a computed dose of a second medicament (secondary drug compound) and a variable dose of a first medicament (primary drug compound) through a single needle assembly, such as a double ended needle assembly.
The drive train may exert a pressure on the bung of each cartridge, respectively, in order to expel the doses of the first and second medicaments. For example, a piston rod may push the bung of a cartridge forward a pre-determined amount for a single dose of medicament. When the cartridge is empty, the piston rod is retracted completely inside the main body 14, so that the empty cartridge can be removed and a new cartridge can be inserted.
A control panel region 60 is provided near the proximal end of the main body 14. Preferably, this control panel region 60 comprises a digital display 80 along with a plurality of human interface elements that can be manipulated by a user to set and inject a combined dose. In this arrangement, the control panel region comprises a first dose setting button 62, a second dose setting button 64 and a third button 66 designated with the symbol ΌΚ." In addition, along the most proximal end of the main body, an injection button 74 is also provided (not visible in the perspective view of Fig. 1 ). The user interface of the drug delivery device may comprise additional buttons, such as a "menu" button, a "back" button, or a "light" button to switch on an illumination of the display. The cartridge holder 40 can be removably attached to the main body 14 and may contain at least two cartridge retainers 50 and 52. Each retainer is configured so as to contain one medicament reservoir, such as a glass cartridge. Preferably, each cartridge contains a different medicament.
In addition, at the distal end of the cartridge holder 40, the drug delivery device illustrated in Fig. 1 includes a dispense interface 200. As will be described in relation to Fig. 4, in one arrangement, this dispense interface 200 includes a main outer body 212 that is removably attached to a distal end 42 of the cartridge housing 40. As can be seen in Fig. 1 , a distal end 214 of the dispense interface 200 preferably comprises a needle hub 216. This needle hub 216 may be configured so as to allow a dose dispenser, such as a conventional pen type injection needle assembly, to be removably mounted to the drug delivery device 10.
Once the device is turned on, the digital display 80 shown in Fig. 1 illuminates and provides the user certain device information, preferably information relating to the medicaments contained within the cartridge holder 40. For example, the user is provided with certain information relating to both the primary medicament (Drug A) and the secondary medicament (Drug B). As shown in Fig. 3, the first and second cartridge retainers 50, 52 may be hinged cartridge retainers. These hinged retainers allow user access to the cartridges. Fig. 3 illustrates a perspective view of the cartridge holder 40 illustrated in Fig. 1 with the first hinged cartridge retainer 50 in an open position. Fig. 3 illustrates how a user might access the first cartridge 90 by opening up the first retainer 50 and thereby having access to the first cartridge 90.
As mentioned above when discussing Fig. 1 , a dispense interface 200 can be coupled to the distal end of the cartridge holder 40. Fig. 4 illustrates a flat view of the dispense interface 200 unconnected to the distal end of the cartridge holder 40. A dose dispenser or needle assembly 400 that may be used with the interface 200 is also illustrated and is provided in a protective outer cap 420.
In Fig. 5, the dispense interface 200 illustrated in Fig. 4 is shown coupled to the cartridge holder 40. The axial attachment means 48 between the dispense interface 200 and the cartridge holder 40 can be any known axial attachment means to those skilled in the art, including snap locks, snap fits, snap rings, keyed slots, and combinations of such
connections. The connection or attachment between the dispense interface and the cartridge holder may also contain additional features (not shown), such as connectors, stops, splines, ribs, grooves, pips, clips and the like design features, that ensure that specific hubs are attachable only to matching drug delivery devices. Such additional features would prevent the insertion of a non-appropriate secondary cartridge to a non-matching injection device. Fig. 5 also illustrates the needle assembly 400 and protective cover 420 coupled to the distal end of the dispense interface 200 that may be screwed onto the needle hub of the interface 200. Fig. 6 illustrates a cross sectional view of the double ended needle assembly 400 mounted on the dispense interface 200 in Fig. 5. The needle assembly 400 illustrated in Fig. 6 comprises a double ended needle 406 and a hub 401 . The double ended needle or cannula 406 is fixedly mounted in a needle hub 401. This needle hub 401 comprises a circular disk shaped element which has along its periphery a circumferential depending sleeve 403. Along an inner wall of this hub member 401 , a thread 404 is provided. This thread 404 allows the needle hub 401 to be screwed onto the dispense interface 200 which, in one preferred arrangement, is provided with a
corresponding outer thread along a distal hub. At a center portion of the hub element 401 there is provided a protrusion 402. This protrusion 402 projects from the hub in an opposite direction of the sleeve member. A double ended needle 406 is mounted centrally through the protrusion 402 and the needle hub 401 . This double ended needle 406 is mounted such that a first or distal piercing end 405 of the double ended needle forms an injecting part for piercing an injection site (e.g., the skin of a user).
Similarly, a second or proximal piercing end 408 of the needle assembly 400 protrudes from an opposite side of the circular disc so that it is concentrically surrounded by the sleeve 403. In one needle assembly arrangement, the second or proximal piercing end 408 may be shorter than the sleeve 403 so that this sleeve to some extent protects the pointed end of the back sleeve. The needle cover cap 420 illustrated in Fig. 4 and 5 provides a form fit around the outer surface 403 of the hub 401. Referring now to Fig. 4 to 1 1 , one preferred arrangement of this interface 200 will now be discussed. In this one preferred arrangement, this interface 200 comprises:
a. a main outer body 210,
b. an first inner body 220,
c. a second inner body 230,
d. a first piercing needle 240,
e. a second piercing needle 250,
f. a valve seal 260, and g. a septum 270.
The main outer body 210 comprises a main body proximal end 212 and a main body distal end 214. At the proximal end 212 of the outer body 210, a connecting member is configured so as to allow the dispense interface 200 to be attached to the distal end of the cartridge holder 40. Preferably, the connecting member is configured so as to allow the dispense interface 200 to be removably connected the cartridge holder 40. In one preferred interface arrangement, the proximal end of the interface 200 is configured with an upwardly extending wall 218 having at least one recess. For example, as may be seen from Fig. 8, the upwardly extending wall 218 comprises at least a first recess 217 and a second recess 219.
Preferably, the first and the second recesses 217, 219 are positioned within this main outer body wall so as to cooperate with an outwardly protruding member located near the distal end of the cartridge housing 40 of the drug delivery device 10. For example, this outwardly protruding member 48 of the cartridge housing may be seen in Fig. 4 and 5. A second similar protruding member is provided on the opposite side of the cartridge housing. As such, when the interface 200 is axially slid over the distal end of the cartridge housing 40, the outwardly protruding members will cooperate with the first and second recess 217, 219 to form an interference fit, form fit, or snap lock. Alternatively, and as those of skill in the art will recognize, any other similar connection mechanism that allows for the dispense interface and the cartridge housing 40 to be axially coupled could be used as well.
The main outer body 210 and the distal end of the cartridge holder 40 act to form an axially engaging snap lock or snap fit arrangement that could be axially slid onto the distal end of the cartridge housing. In one alternative arrangement, the dispense interface 200 may be provided with a coding feature so as to prevent inadvertent dispense interface cross use. That is, the inner body of the hub could be geometrically configured so as to prevent an inadvertent cross use of one or more dispense interfaces. A mounting hub is provided at a distal end of the main outer body 210 of the dispense interface 200. Such a mounting hub can be configured to be releasably connected to a needle assembly. As just one example, this connecting means 216 may comprise an outer thread that engages an inner thread provided along an inner wall surface of a needle hub of a needle assembly, such as the needle assembly 400 illustrated in Fig. 6. Alternative releasable connectors may also be provided such as a snap lock, a snap lock released through threads, a bayonet lock, a form fit, or other similar connection arrangements. The dispense interface 200 further comprises a first inner body 220. Certain details of this inner body are illustrated in Fig. 8-1 1. Preferably, this first inner body 220 is coupled to an inner surface 215 of the extending wall 218 of the main outer body 210. More preferably, this first inner body 220 is coupled by way of a rib and groove form fit arrangement to an inner surface of the outer body 210. For example, as can be seen from Fig. 9, the extending wall 218 of the main outer body 210 is provided with a first rib 213a and a second rib 213b. This first rib 213a is also illustrated in Fig. 10. These ribs 213a and 213b are positioned along the inner surface 215 of the wall 218 of the outer body 210 and create a form fit or snap lock engagement with cooperating grooves 224a and 224b of the first inner body 220. In a preferred arrangement, these cooperating grooves 224a and 224b are provided along an outer surface 222 of the first inner body 220.
In addition, as can be seen in Fig. 8-10, a proximal surface 226 near the proximal end of the first inner body 220 may be configured with at least a first proximally positioned piercing needle 240 comprising a proximal piercing end portion 244. Similarly, the first inner body 220 is configured with a second proximally positioned piercing needle 250 comprising a proximally piercing end portion 254. Both the first and second needles 240, 250 are rigidly mounted on the proximal surface 226 of the first inner body 220. Preferably, this dispense interface 200 further comprises a valve arrangement. Such a valve arrangement could be constructed so as to prevent cross contamination of the first and second medicaments contained in the first and second reservoirs, respectively. A preferred valve arrangement may also be configured so as to prevent back flow and cross
contamination of the first and second medicaments.
In one preferred system, dispense interface 200 includes a valve arrangement in the form of a valve seal 260. Such a valve seal 260 may be provided within a cavity 231 defined by the second inner body 230, so as to form a holding chamber 280. Preferably, cavity 231 resides along an upper surface of the second inner body 230. This valve seal comprises an upper surface that defines both a first fluid groove 264 and second fluid groove 266. For example, Fig. 9 illustrates the position of the valve seal 260, seated between the first inner body 220 and the second inner body 230. During an injection step, this seal valve 260 helps to prevent the primary medicament in the first pathway from migrating to the secondary medicament in the second pathway, while also preventing the secondary medicament in the second pathway from migrating to the primary medicament in the first pathway. Preferably, this seal valve 260 comprises a first non-return valve 262 and a second non-return valve 268. As such, the first non-return valve 262 prevents fluid transferring along the first fluid pathway 264, for example a groove in the seal valve 260, from returning back into this pathway 264. Similarly, the second non-return valve 268 prevents fluid transferring along the second fluid pathway 266 from returning back into this pathway 266. Together, the first and second grooves 264, 266 converge towards the non-return valves 262 and 268 respectively, to then provide for an output fluid path or a holding chamber 280. This holding chamber 280 is defined by an inner chamber defined by a distal end of the second inner body both the first and the second non return valves 262, 268 along with a pierceable septum 270. As illustrated, this pierceable septum 270 is positioned between a distal end portion of the second inner body 230 and an inner surface defined by the needle hub of the main outer body 210.
The holding chamber 280 terminates at an outlet port of the interface 200. This outlet port 290 is preferably centrally located in the needle hub of the interface 200 and assists in maintaining the pierceable seal 270 in a stationary position. As such, when a double ended needle assembly is attached to the needle hub of the interface (such as the double ended needle illustrated in Fig. 6), the output fluid path allows both medicaments to be in fluid communication with the attached needle assembly. The hub interface 200 further comprises a second inner body 230. As can be seen from Fig. 9, this second inner body 230 has an upper surface that defines a recess, and the valve seal 260 is positioned within this recess. Therefore, when the interface 200 is assembled as shown in Fig. 9, the second inner body 230 will be positioned between a distal end of the outer body 210 and the first inner body 220. Together, second inner body 230 and the main outer body hold the septum 270 in place. The distal end of the inner body 230 may also form a cavity or holding chamber that can be configured to be fluid communication with both the first groove 264 and the second groove 266 of the valve seal.
Axially sliding the main outer body 210 over the distal end of the drug delivery device attaches the dispense interface 200 to the multi-use device. In this manner, a fluid communication may be created between the first needle 240 and the second needle 250 with the primary medicament of the first cartridge and the secondary medicament of the second cartridge, respectively. Fig. 1 1 illustrates the dispense interface 200 after it has been mounted onto the distal end 42 of the cartridge holder 40 of the drug delivery device 10 illustrated in Fig. 1. A double ended needle 400 is also mounted to the distal end of this interface. The cartridge holder 40 is illustrated as having a first cartridge containing a first medicament and a second cartridge containing a second medicament.
When the interface 200 is first mounted over the distal end of the cartridge holder 40, the proximal piercing end 244 of the first piercing needle 240 pierces the septum of the first cartridge 90 and thereby resides in fluid communication with the primary medicament 92 of the first cartridge 90. A distal end of the first piercing needle 240 will also be in fluid communication with a first fluid path groove 264 defined by the valve seal 260. Similarly, the proximal piercing end 254 of the second piercing needle 250 pierces the septum of the second cartridge 100 and thereby resides in fluid communication with the secondary medicament 102 of the second cartridge 100. A distal end of this second piercing needle 250 will also be in fluid communication with a second fluid path groove 266 defined by the valve seal 260.
Fig. 1 1 illustrates a preferred arrangement of such a dispense interface 200 that is coupled to a distal end 15 of the main body 14 of drug delivery device 10. Preferably, such a dispense interface 200 is removably coupled to the cartridge holder 40 of the drug delivery device 10. As illustrated in Fig. 1 1 , the dispense interface 200 is coupled to the distal end of a cartridge housing 40. This cartridge holder 40 is illustrated as containing the first cartridge 90 containing the primary medicament 92 and the second cartridge 100 containing the secondary medicament 102. Once coupled to the cartridge housing 40, the dispense interface 200 essentially provides a mechanism for providing a fluid communication path from the first and second cartridges 90, 100 to the common holding chamber 280. This holding chamber 280 is illustrated as being in fluid communication with a dose dispenser. Here, as illustrated, this dose dispenser comprises the double ended needle assembly 400. As illustrated, the proximal end of the double ended needle assembly is in fluid
communication with the chamber 280.
In one preferred arrangement, the dispense interface is configured so that it attaches to the main body in only one orientation, that is it is fitted only one way round. As such as illustrated in Fig. 1 1 , once the dispense interface 200 is attached to the cartridge holder 40, the primary needle 240 can only be used for fluid communication with the primary medicament 92 of the first cartridge 90 and the interface 200 would be prevented from being reattached to the holder 40 so that the primary needle 240 could now be used for fluid communication with the secondary medicament 102 of the second cartridge 100. Such a one way around connecting mechanism may help to reduce potential cross contamination between the two medicaments 92 and 102.
Figure 12 shows a perspective view of an alternative embodiment of the delivery device shown in Fig. 1 . The delivery device shown in Fig. 12 differs from the delivery device in Fig. 1 in that the device further comprises a sensor 502 to detect whether end cap 18 is attached to the distal end 15 of main body 14. Cap 18 here constitutes to a detachable element and the distal end 15 acts as the coupling portion for attaching thereto the detachable element. The delivery device shown in Fig. 12 furthermore comprises door opening buttons 504, 506 for opening cartridge retainers 50, 52.
Sensor 502 may be for example a reed or hall sensor and the cap 18 may comprise a corresponding magnet 508 which creates a magnetic field that is detected by sensor 502 when cap 18 is properly attached to the device. Magnet 508 may for example be embedded into the cap material as illustrated in Fig. 12. Sensor 502 is therewith configured to detect attachment or detachment of cap 18 to or from the distal end 15 of the main body 14.
The device shown in Fig. 12 has a plurality of human interface elements such as in particular first dose setting button 62, second dose setting button 64, an ΌΚ" button 66 and buttons 504, 506 and a return button (not shown) to go back one step in almost all situation and a injection button 74 to start and stop / pause the injection and a sound button (not shown) to choose between 4 sound volume level. These buttons all constitute input elements of the device being actuatable by a user action, namely by pressing the respective buttons.
Furthermore, also sensor 502 may constitute an input element which the user may actuate by attaching or detaching cap 18 to or from distal end 50.
Digital display 80 of the delivery device constitutes an output interface for outputting messages to a user, in particular text and/or graphical messages. During the first use of the delivery device, the user is usually requested to select a language for the messages to be displayed on digital display 80 during operation of the device.
If the user selects the wrong language or if the wrong language was preset by the
manufacturer or vendor of the device or if a wrong language is selected due to a software error, the user may not be able to read the messages output on the digital display 80. For such a case, the device offers a possibility to reset the language during a language setting or resetting step. Since the delivery device in Fig. 12 only has a limited number of input elements, there is no particular input element exclusively available to trigger the language setting or resetting step. Moreover, the language setting step shall not be triggered inadvertently during regular operation of the apparatus. Therefore, the control unit of the delivery device in Fig. 12 is configured to perform the language setting or resetting step upon detection of a predefined user input, the predefined user input comprising actuation of at least two of the input elements of the device.
An example for such a predefined user input is now illustrated with reference to Fig. 13, which shows a flow chart for detection of predefined user input by the control unit of the device in Fig. 12.
Generally, the predefined user input may be performed from any state or operation of the delivery device (step 602). However, it may be advantageous to exclude some status or operations, such as during an injection or during a motor movement. During such a status or operation it is then not possible for the user to trigger the language setting or resetting step by performing the predefined user input.
According to a specific example, the predefined user input may comprise the following in the given order:
in a status, in which the cap 18 is attached to the distal end 15, the "UP" button 62 is pressed and hold down by the user,
then cap 18 is detached from the delivery device,
then injection button 74 is pressed and hold down by the user,
- then buttons 62 and 74 are hold down together for a minimum time of at least 400 ms before the user releases said buttons.
The device then continues to the language setting or resetting step or enters the language change function. At this time, the device may generate a confirmation tone or sound.
A possible control sequence for detecting such a predefined user input is now explained with reference to Fig. 13. From the initial state 602 the control unit first determines by sensor 502 whether the cap 18 is attached to the distal end 15 and whether button 62 is pressed and held down by the user (step 604). If this is the case, the control unit then determines by means of sensor 502 whether the user removes the cap while still holding down button 62 (step 606). If this is the case, the control unit then determines whether the user presses ejection button 74 while still holding down button 62 (step 608). If this is the case, the control unit detects whether buttons 62 and 74 are hold down together for a time period of at least 400 ms before the buttons 62 and 74 are released (step 610). If this is also the case, the control unit has detected the predefined user input and therefore performs the language setting or resetting step (step 612).
If at any of steps 604, 606, 608 and 610 the control unit detects that one of the respective conditions is not fulfilled, the control unit returns to the initial state 602, so that the user would have to perform the predefined user input from the start for triggering the language setting step.
In an alternative embodiment, one of the door opening buttons 504, 506 may have to be pressed in step 608 instead of the ejection button 74.
With the predefined user input being a complex sequence as the sequence described above, it is very unlikely that the predefined user input is performed inadvertently, i.e. when the user does not intend to perform the language setting step. However, such a predefined user input is still simple enough to be remembered and performed by a user.
Figure 14 shows a flow chart of an exemplary language setting step, such as the language setting or resetting step 612 triggered by the predefined user input described above.
The language setting step starts in step 702. In step 704, the control unit causes digital display 80 to display a menu with several languages as menu items such as "English", "Deutsch", "Frangais" etc. each language menu item in its own language. The current selection of the language, i.e. the language corresponding to the current value of the message language setup variable is highlighted, for example by underlining, or by bold type. For example, if the message language setup variable is numeric and "1 " corresponds to "English", "2" corresponds to "German" and "3" corresponds to "French", the menu item "German" is highlighted if the value of the message language setup variable equals "2".
In step 706, the control unit determines whether the user presses a particular button of the delivery device. If the user presses "UP" button 62 or "DOWN" button 64, control unit continues with step 708, in which it changes the value of the message language setup variable accordingly. For example, the control unit may increase a numeric message language setup variable by "1 " if the user has pressed "UP" button 62, and decrease it by "1 " if the user has pressed "DOWN" button 64. The control unit then continues with step 704 and again displays the menu in which now a different language is highlighted.
If the user in step 706 finally presses the "OK" button 66, control unit ends the language setting step (step 710), so that the value of the message language setup variable keeps the value previously selected by the user during the language setting step.
The term "drug" or "medicament", as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1 ) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.
Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin. Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl- des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N- lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(oo-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(oo-carboxyhepta-,decanoyl) human insulin.
Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H His-Gly-Glu- Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-lle-Glu- Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
Exendin-4 derivatives are for example selected from the following list of compounds: H-(Lys)4-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,
H-(Lys)5-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,
des Pro36 [Asp28] Exendin-4(1 -39),
des Pro36 [lsoAsp28] Exendin-4(1 -39),
des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39),
des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1 -39),
des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39),
des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1 -39),
des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1 -39),
des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1 -39); or des Pro36 [Asp28] Exendin-4(1 -39),
des Pro36 [lsoAsp28] Exendin-4(1 -39),
des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39),
des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1 -39),
des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39),
des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1 -39),
des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1 -39),
des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1 -39),
wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative of the sequence
H-(Lys)6-des Pro36 [Asp28] Exendin-4(1 -39)-Lys6-NH2, des Asp28 Pro36, Pro37, Pro38Exendin-4(1 -39)-NH2,
H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1 -39)-NH2,
H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-NH2,
des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-(Lys)6-des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Trp(02)25] Exendin-4(1 -39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39)-Lys6-NH2,
des Met(0)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1 -39)-NH2,
H-(Lys)6-desPro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25] Exendin-4(1 -39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(S1 -39)-(Lys)6- NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)- (Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative.
Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. Antibodies are globular plasma proteins (-150 kDa) that are also known as immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.
The Ig monomer is a "Y"-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-1 10 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two β sheets create a "sandwich" shape, held together by interactions between conserved cysteines and other charged amino acids.
There are five types of mammalian Ig heavy chain denoted by α, δ, ε, γ, and μ. The type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
Distinct heavy chains differ in size and composition; a and γ contain approximately 450 amino acids and δ approximately 500 amino acids, while μ and ε have approximately 550 amino acids. Each heavy chain has two regions, the constant region (CH) and the variable region (VH). In one species, the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes. Heavy chains γ, a and δ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains μ and ε have a constant region composed of four immunoglobulin domains. The variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 1 10 amino acids long and is composed of a single Ig domain.
In mammals, there are two types of immunoglobulin light chain denoted by λ and κ. A light chain has two successive domains: one constant domain (CL) and one variable domain (VL). The approximate length of a light chain is 21 1 to 217 amino acids. Each antibody contains two light chains that are always identical; only one type of light chain, κ or λ, is present per antibody in mammals.
Although the general structure of all antibodies is very similar, the unique property of a given antibody is determined by the variable (V) regions, as detailed above. More specifically, variable loops, three each the light (VL) and three on the heavy (VH) chain, are responsible for binding to the antigen, i.e. for its antigen specificity. These loops are referred to as the Complementarity Determining Regions (CDRs). Because CDRs from both VH and VL domains contribute to the antigen-binding site, it is the combination of the heavy and the light chains, and not either alone, that determines the final antigen specificity.
An "antibody fragment" contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab). The third fragment, similar in size but containing the carboxyl terminal half of both heavy chains with their interchain disulfide bond, is the crystalizable fragment (Fc). The Fc contains carbohydrates, complement-binding, and FcR-binding sites. Limited pepsin digestion yields a single F(ab')2 fragment containing both Fab pieces and the hinge region, including the H-H interchain disulfide bond. F(ab')2 is divalent for antigen binding. The disulfide bond of F(ab')2 may be cleaved in order to obtain Fab'. Moreover, the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv).
Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1 )(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6- C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology.
Pharmaceutically acceptable solvates are for example hydrates.

Claims

Claims 1 . A medical apparatus,
having a user interface for outputting messages to a user,
having at least two input elements, each input element being actuatable by a user action,
having a control unit configured to control the apparatus, and
- having a storage for storing a message language setup variable,
wherein the control unit is configured to perform a language setting step (612), during which a value of the message language setup variable is selected as a function of a user input, and
wherein the control unit is configured to select the language of messages to be output by means of the user interface as a function of the message language setup variable, characterized in that
the control unit is further configured to perform the language setting step (612) upon detection of a predefined user input, the predefined user input comprising actuation of at least two of the input elements during a single user input.
2. The medical apparatus according to claim 1 ,
wherein the predefined user input comprises sequential actuation of at least two of the input elements.
The medical apparatus according to claim 1 or 2,
wherein the predefined user input comprises actuation of a first input element and subsequent actuation of a second input element while still actuating the first input element.
The medical apparatus according to any one of claims 1 to 3,
wherein the predefined user input comprises actuation of at least one input element for a predefined time period, in particular pressing a button for a predefined time period.
The medical apparatus according to any one of claims 1 to 4,
wherein the apparatus comprises a coupling portion for attaching thereto a detachable element and an input element configured as a sensor (502) to detect attachment or detachment of the detachable element, and wherein the predefined user input comprises attaching of the detachable element to the coupling portion and/or detaching the detachable element from the coupling portion.
The medical apparatus according to any one of claims 1 to 5,
wherein the apparatus comprises a portion being movable relative to the apparatus by rotation and/or translation and an input element configured as a sensor to detect movement of said portion, and wherein the predefined user input comprises movement of said portion.
The medical apparatus according to any one of claim 1 to 6,
wherein the predefined user input comprises the following in the given order:
pressing and holding a first button (62, 64, 66, 74, 504, 506),
detaching or attaching a detachable element,
pressing and holding a second button (62, 64, 66, 74, 504, 506), holding the first and second button for a predefined time, and
releasing the first and second button (62, 64, 66, 74, 504, 506).
The medical apparatus according to any one of claims 1 to 7,
wherein the storage is configured to store a value of user operation related data in at least one user operation data variable and wherein the control unit is configured to maintain the value of the at least one user operation data variable during the control sequence performed upon detection of the predefined user input.
The medical apparatus according to any one of claims 1 to 8,
wherein the control unit is configured to output a confirmation message, in particular a confirmation sound, upon detection of the predefined user input.
The medical apparatus according to any one of claims 1 to 9,
wherein the medical apparatus is a medicament injection device.
The medical apparatus according to any one of claims 1 to 10,
wherein the medical apparatus is hand-held. 12. Method for controlling a medical apparatus according to one of claims 1 to 1 1 ,
comprising the steps of: performing a language setting step, during which a value of a message language setup variable is selected as a function of a user input; and
outputting messages on a user interface, wherein the language of the messages is selected as a function of the message language setup variable,
characterized in that
the language setting step is performed upon detection of a predefined user input, the predefined user input comprising actuation of at least two input elements.
PCT/EP2014/074030 2013-11-07 2014-11-07 Apparatus with language reset feature and method for controlling such an apparatus WO2015067747A1 (en)

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EP13191982 2013-11-07

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