WO2014111336A1 - Dispositif d'injection de médicament de type stylo et module de surveillance auxiliaire électronique pour surveiller et enregistrer le réglage et l'administration de dose - Google Patents

Dispositif d'injection de médicament de type stylo et module de surveillance auxiliaire électronique pour surveiller et enregistrer le réglage et l'administration de dose Download PDF

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Publication number
WO2014111336A1
WO2014111336A1 PCT/EP2014/050463 EP2014050463W WO2014111336A1 WO 2014111336 A1 WO2014111336 A1 WO 2014111336A1 EP 2014050463 W EP2014050463 W EP 2014050463W WO 2014111336 A1 WO2014111336 A1 WO 2014111336A1
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WO
WIPO (PCT)
Prior art keywords
injection device
supplemental
code
supplemental device
sensor
Prior art date
Application number
PCT/EP2014/050463
Other languages
English (en)
Inventor
Samuel STEEL
Paul Richard Draper
George Cave
David Richard Mercer
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 WO2014111336A1 publication Critical patent/WO2014111336A1/fr

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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
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • 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
    • A61M5/31525—Dosing
    • 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
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • 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
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
    • 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
    • A61M5/3129—Syringe barrels
    • A61M2005/3142—Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • 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
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • 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
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • 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
    • 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
    • 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
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • 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
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6045—General characteristics of the apparatus with identification means having complementary physical shapes for indexing or registration purposes
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/04—Tools for specific apparatus
    • 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

Definitions

  • the present invention relates to a supplemental device for attachment to an injection device.
  • Such injection can be performed by using injection devices, which are applied either by medical personnel or by patients themselves.
  • type-1 and type-2 diabetes can be treated by patients themselves by injection of insulin doses, for example once or several times per day.
  • a prefilled disposable insulin pen can be used as an injection device.
  • a re-usable pen may be used.
  • a reusable pen allows replacement of an empty medicament cartridge by a new one. Either pen may come with a set of one-way needles that are replaced before each use.
  • the insulin dose to be injected can then for instance be manually selected at the insulin pen by turning a dosage knob and observing the actual dose ("dialled dose") from a dose window or display of the insulin pen.
  • the injection device is then in a dialled state/mode.
  • the dose is then injected/dispensed by inserting the needle into a suitable skin portion and pressing an injection button of the insulin pen.
  • the injection device is then in a dispensed state/mode.
  • information related to a condition and/or use of the injection device such as for instance information on injected insulin type and dose.
  • a user undertaking self-administration of insulin will commonly need to administer between 1 and 80 International Units. It has been described, for instance in WO 201 1/1 17212 to provide a supplementary device comprising a mating unit for releasably attaching the device to an injection device.
  • the device includes a camera and is configured to perform optical character recognition (OCR) on captured images visible through a dosage window of the injection pen, thereby to determine a dose of medicament that has been dialled into the injection device.
  • OCR optical character recognition
  • a first aspect of the invention provides a supplemental device for releasable attachment to an encoded injection device, the supplemental device comprising:
  • a housing having a recess arranged to receive a protrusion provided on the outer surface of the injection device
  • the sensor of the supplemental device is rotationally aligned with the code of the injection device.
  • the supplemental device ensures that when a user attaches it to a complimentary injection device, an on-board sensor is correctly aligned with code provided on the injection device.
  • a protrusion/recess arrangement allows a user to ensure that the sensor is rotationally aligned with code provided on the injection device. Accordingly, the sensor is able to read the information provided by the code.
  • the supplemental device may be capable of reading, recording and displaying dialled, and in some cases dispensed, dose volumes as well as the mode state "e.g. dialled or dispensed" of the injection device.
  • the sensor of the supplemental device may be an optical sensor or a conductive sensor.
  • the encoded injection device may further comprise a code access aperture. The sensor may then read the code provided on a part of the injection device viewed through the aperture.
  • the code access aperture provided on the injection device may be a window/lens.
  • the code access aperture may also be the protrusion provided on the injection device.
  • the code access aperture and the protrusion provided on the injection device may be different. In one embodiment, where the code access aperture and the protrusion provided on the injection device are different, the sensor is not a colour sensor or a camera capable of reading numbers provided on the injection device.
  • the code provided on the injection device may be conductive code or optical code. That is, the injection device may be conductively encoded or optically encoded. Conductive code requires a physical interaction with metallic contacts on the supplemental device. Optical code is read by an optical sensor on the supplemental device. The encoded injection device provides code on the injection device that may provide information relating to the dialled, and in some cases
  • the supplemental device may comprise metallic contacts that, when the recess of the supplemental device is engaged with the protrusion of the injection device, are aligned with conductive code provided on the injection device.
  • the supplemental device may comprise an optical sensor that, when the recess of the supplemental device is engaged with the protrusion of the injection device, is aligned with optical code provided on the injection device.
  • the recess of the supplemental device may extend through the entire width of the housing.
  • the supplemental device may therefore comprise a housing having an open slot arranged to receive a protrusion provided on the encoded injection device so that when the protrusion is engaged with the slot the sensor of the supplemental device is rotationally aligned with code provided on the injection device.
  • the supplemental device may further comprise a clip comprising at least one flexible arm arranged to engage with a circumferential recess provided on the injection device, wherein when the flexible arm is engaged with the circumferential recess the sensor of the supplemental device is axially aligned with the code of the injection device.
  • the circumferential recess may extend around at least part or the entire circumference of the injection device.
  • the supplemental device may comprise such a clip comprising two flexible arms arranged to engage with the circumferential recess on opposite sides of the injection device.
  • a second aspect of the invention provides a system comprising a supplemental device according to the first aspect of the invention and an encoded injection device comprising code and a protrusion on its outer surface arranged to engage with the recess of the supplemental device.
  • the encoded injection device may comprise more than one, for example two, protrusions on its outer surface arranged to engage with the recess of the supplemental device.
  • the code provided on the injection device may be optical code or conductive code.
  • a third aspect of the invention provides a supplemental device for releasable
  • the supplemental device comprising at least one sensor, and a housing having at least one clip comprising at least one flexible arm arranged to engage with a discrete recess provided on the outer surface of the injection device,
  • the supplemental device ensures that when a user attaches it to a complimentary injection device, an on-board sensor is correctly aligned with code provided on the injection device.
  • the arrangement ensures that a user is able to attach the supplemental device to the injection device such that the sensor is both rotationally and axially aligned with code provided on the injection device. Accordingly, the sensor is able to read the information provided by the code.
  • the supplemental device may comprise a clip comprising two flexible arms arranged to engage with two discrete recesses provided on the injection device, wherein when the two flexible arms are engaged with the two discrete recesses of the injection device, the sensor of the supplemental device is axially and rotationally aligned with code provided on the injection device.
  • the two discrete recesses provided on the injection device may be provided on opposite sides of the injection device.
  • the sensor of the supplemental device may be an optical sensor or a conductive sensor.
  • a fourth aspect of the invention provides a system comprising a supplemental device according to the third aspect of the invention and an encoded injection device which comprises code and at least one discrete recess arranged to receive a flexible arm of the supplemental device.
  • a fifth aspect of the invention provides a supplemental device for releasable attachment to an encoded injection device, the supplemental device comprising:
  • a housing having a protrusion arranged to engage with a recess provided on the outer surface of the injection device
  • the sensor of the supplemental device is rotationally and axially aligned with code provided on the injection device.
  • the supplemental device ensures that when a user attaches it to a complimentary injection device, an on-board sensor is correctly aligned with code provided on the injection device.
  • a recess/protrusion arrangement allows a user to ensure that the sensor is rotationally aligned with code provided on the injection device. Accordingly, the sensor is able to read the information provided by the code.
  • the sensor of the supplemental device may be a conductive sensor or an optical sensor.
  • a sixth aspect of the invention provides a system comprising a supplemental device according to the fifth aspect of the invention and an encoded injection device comprising code and a recess on the outer surface of the injection device arranged to receive the protrusion of the supplemental device.
  • the code provided on the injection device may be conductive code or optical code.
  • a seventh aspect of the invention provides an encoded injection device comprising code, a housing having a code access aperture through which the code is accessed by a sensor provided on a supplemental device, and a removable cover over the code access aperture.
  • the removable cover denies access to the code access aperture before the injection device is used. This ensures that the internal workings of the injection device are not contaminated with dirt and other alien objects that may hinder the operation, and in particular the dispense mechanism, of the injection device.
  • the removable cover may be a tear-off tag or a label.
  • the label may be perforated.
  • the code of the encoded injection device may comprise optical code.
  • the supplemental device employed in the seventh aspect of the invention may be any supplemental device described above in the context of the first, third and fifth aspects of the invention.
  • An eighth aspect of the invention provides a system comprising:
  • an encoded injection device as defined in claim 16, wherein the code access aperture comprises a recess in the housing of the injection device and wherein the removable cover is a label, and
  • a supplemental device for releasable attachment to the encoded injection device comprising:
  • a ninth aspect of the invention relates to a supplemental device that is configured for releasable attachment to an encoded injection device according to the seventh aspect of the invention.
  • the supplemental device has a sensor configured to determine information relating to a dialed and/or dispensed dose volume of the injection device and further comprises
  • the protruding feature is configured to pierce a label and push the label aside to allow access to the the aperture
  • the protruding feature is configured to pierce a label and peel it away from the aperture.
  • protruding feature is located on a sprung arm.
  • the protruding feature is configured to engage with the access aperture to circumferentially/rotationally fix the supplemental device relative to the injection device
  • a tenth aspect of the invention relates to a system comprising an encoded injection device according to the seventh aspect, and a supplemental device according to the ninth aspect of the invention.
  • the supplemental device employed in the ninth and tenth aspect of the invention may be any supplemental device described above in the context of the first, third and fifth aspects of the invention.
  • Fig. 1 is an exploded view of an injection device
  • Fig. 2a a schematic illustration of a supplementary device to be releasably attached to the injection device of Fig. 1 according to an embodiment of the present invention
  • Fig. 2b a perspective view of a supplementary device to be releasably attached to the injection device of Fig. 1 according to various embodiments of the present invention
  • Fig. 2c a perspective view of a supplementary device to be releasably attached to the injection device of Fig. 1 according to other embodiments of the present invention
  • Figs. 3a and 3b possible distributions of functions among devices when using a supplementary device (such as the supplementary devices of Fig. 2a, 2b and 2c) together with an injection device;
  • a supplementary device such as the supplementary devices of Fig. 2a, 2b and 2c
  • Fig. 4 a schematic view of the supplementary device of Fig. 2a in a state where it is attached to the injection device of Fig. 1 ;
  • Figs. 5a and 5b illustrate a supplemental device according to the first aspect of the invention and a system according to the second aspect of the invention.
  • Fig. 6 provides a prospective view of some detail relating to Figs. 5a and 5b.
  • Figs. 7-10 illustrate embodiments of a supplemental device according to the first aspect of the present invention and a system according to the second aspect of the present invention.
  • Fig. 1 1 illustrates a supplemental device according to the third aspect of the invention and a system according to the fourth aspect of the invention.
  • Fig. 12 illustrates an encoded injection device useful in combination with a supplemental device according to either the first or third aspects of the invention, or useful in the context of a system according to the second or fourth aspects of the invention.
  • Figs. 13-15 illustrate a supplemental device according to the first aspect of the invention having a partly cylindrical hollow space to receive an injection device.
  • Fig. 16 illustrates an alternative embodiment of an encoded injection device useful in the context of the second aspect of the invention.
  • the injection device shown has two protrusions.
  • Figs. 17 and 18 illustrate an embodiment of the first and second aspects of the invention.
  • Fig. 19 illustrates an embodiment of the fifth and sixth aspects of the invention.
  • Figs. 20-23 illustrate embodiments of the seventh aspect of the invention.
  • FIG. 1 is an exploded view of an injection device 1 , which may for instance represent Sanofi's Solo Star® insulin injection pen.
  • the injection device of Fig. 1 is a pre-filled, disposable injection pen that comprises a housing 10 and contains an insulin container 14, to which a needle 15 can be affixed.
  • the needle is protected by an inner needle cap 16 and an outer needle cap 17, which in turn can be covered by a cap 18.
  • An insulin dose to be ejected from injection device 1 can be selected by turning the dosage knob 12 and the selected dose is then displayed by a dosage window 13, for instance in multiples of so-called International Units (IU), wherein 1 IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin (1/22mg).
  • An example of the selected dose displayed in dosage window 13 may for instance be 30 lUs, as shown in Fig. 1 . It should be noted that the selected dose may equally well be displayed differently, for instance by means of an electronic display.
  • dosage knob 12 causes a mechanical click sound to provide acoustical feedback to a user.
  • the numbers displayed in dosage window 13 are printed on a sleeve that is contained in housing 10 and mechanically interacts with dosage knob 12 during dose setting and with a piston rod (not shown) during dispense which is
  • This sleeve also has encoded information relating to the dose. Therefore, the position of the sleeve is indicative of the actual dose that a user has dialed in and that is displayed, as described before.
  • the encoded information is in the form of an optical gray code. Alternatively the information could be encoded differently, e.g. being a bar code, a matrix code or even glyphs. However, the code cannot be seen because it is hidden behind the outer housing of the injection device. In order to provide access to the code the device can have an opening, window, cut-out or the like. Such a code access aperture is described later on. Injection devices having a code access aperture are particularly configured to cooperate with particularly configured supplemental devices that are described in the context of particular embodiments.
  • injection button 1 1 When needle 15 is stuck into a skin portion of a patient, and then injection button 1 1 is pushed, the insulin dose displayed in display window 13 will be ejected from injection device 1 .
  • the needle 15 of injection device 1 remains for a certain time in the skin portion after the injection button 1 1 is pushed, a high percentage of the dose is actually injected into the patient's body. Ejection of the insulin dose also causes a mechanical click sound, which is however different from the sounds produced when using dosage knob 12.
  • Injection device 1 may be used for several injection processes until either insulin container 14 is empty or the expiration date of injection device (e.g. 28 days after the first use) is reached.
  • injection device 1 before using injection device 1 for the first time, it may be necessary to perform a so-called "prime shot” to remove air from insulin container 14 and needle 15, for instance by selecting two units of insulin and pressing injection button 1 1 while holding injection device 1 with the needle 15 upwards.
  • a so-called "prime shot” to remove air from insulin container 14 and needle 15, for instance by selecting two units of insulin and pressing injection button 1 1 while holding injection device 1 with the needle 15 upwards.
  • Fig. 2a is a schematic illustration of an embodiment of a supplementary device 2 to be releasably attached to injection device 1 of Fig. 1 .
  • Supplemental device 2 comprises a housing 20 with a mating unit configured to embrace the housing 10 of injection device 1 of Fig.
  • supplemental device 2 sits tightly on housing 10 of injection device 1 , but is nevertheless removable from injection device 1 , for instance when injection device 1 is empty and has to be replaced.
  • Fig. 2a is highly schematic, and details of the physical arrangement are described below with reference to Fig. 2b.
  • Supplemental device 2 contains sensors for gathering information from injection device 1 . Information is displayed via display unit 21 of supplemental device 2. Dosage window 13 of injection device 1 is obstructed by supplemental device 2 when attached to injection device 1 . Alternatively (not shown), the dosage window 13 of the injection device is not obstructed by supplemental device 2 when attached to injection device 1 .
  • Supplemental device 2 further comprises 3 user input transducers, illustrated
  • buttons 22 schematically as a button 22.
  • These input transducers 22 allow a user to turn on/off supplemental device 2, to trigger actions (for instance to cause establishment of a connection to or a pairing with another device, and/or to trigger transmission of information from supplemental device 2 to another device), or to confirm something.
  • Fig. 2b is a schematic illustration of a second embodiment of a supplemental device 2 to be releasably attached to injection device 1 of Fig. 1 .
  • Supplemental device 2 comprises a housing 20 with a mating unit configured to embrace the housing 10 of injection device 1 of Fig. 1 , so that supplemental device 2 sits tightly on housing 10 of injection device 1 , but is nevertheless removable from injection device 1 .
  • the dosage window 13 of injection device 1 is obstructed by supplemental device 2 when attached to injection device 1 .
  • the dosage window 13 of the injection device is not obstructed by supplemental device 2 when attached to injection device 1 .
  • Supplemental device 2 further comprises a touch-sensitive input transducer 35. It also comprises a single user input button or switch 22. Button 22 is a power on/off button, via which the supplemental device 2 may for instance be turned on and off.
  • the touch sensitive input transducer 35 can be used to trigger actions (for instance to cause establishment of the connection to or a pairing with another device, and/or to trigger transmission of information from supplemental device 2 to another device), or to confirm something.
  • Figs. 3a and 3b show possible distributions of functions among devices when using a supplemental device (such as the supplemental devices of Figs. 2a and 2b) together with an injection device.
  • the supplementary device 41 determines information from injection device 40, and provides this information (e.g. type and/or dose of the medicament to be injected) to a blood glucose monitoring system 42 (e.g. via a wired or wireless connection).
  • Blood glucose monitoring system 42 (which may for instance be embodied as desktop computer, personal digital assistance, mobile phone, tablet computer, notebook, netbook or ultrabook) keeps a record of injections the patient has received so far (based on the ejected doses, for instance by assuming that the ejected doses and the injected doses are the same, or by determining the injected doses based on the ejected doses, for instance by assuming that a predefined percentage of the ejected dose is not completely received by the patient). Blood glucose monitoring system 42 may for instance propose a type and/or dose of insulin for the next injection for this patient.
  • blood glucose meter 43 may be embodied as a separate device that is configured to receive a small blood probe (for instance on a carrier material) of a patient and to determine the blood glucose level of the patient based on this blood probe.
  • Blood glucose meter 43 may however be also be a device that is at least temporarily implanted into the patient, for instance in the patient's eye or beneath the skin.
  • Fig. 3b is a modified constellation 4' where the blood glucose meter 43 of Fig. 3a has been included into the blood glucose monitoring system 42 of Fig. 3a, thus yielding the modified blood glucose monitoring system 42' of Fig. 3b.
  • the functionalities of injection device 40 and supplemental device 41 of Fig. 3a are not affected by this modification.
  • the functionality of blood glucose monitoring system 42 and blood glucose meter 43 combined into blood glucose monitoring system 42' are basically unchanged, apart from the fact that both are now comprised in the same device, both as external wired or wireless communication between the device that is no longer necessary. However, communication between blood glucose monitoring system 42 and blood glucose meter 43 takes place within system 42'.
  • Fig. 4 shows a schematic view of the supplemental device 2 of Fig. 2a in a state where it is attached to injection device 1 of Fig. 1 .
  • a plurality of components are comprised. These are controlled by a processor 24, which may for instance be a microprocessor, a digital signal processer (DSP), application specific integrated circuits (ASIC), field programmable gate array (FPGA) or the like.
  • Processor 24 executes program code (e.g. software or firmware) stored in a program memory 240 and uses a main memory 241 , for instance to store intermediate results.
  • Main memory 241 may also be used to store a logbook on performed ejections/injections.
  • Program memory 240 may for instance be a read only memory (ROM), and main memory may for instance be a random access memory (RAM).
  • processor 24 interacts with a first button 22, via which supplemental device 2 may for instance be turned on and off.
  • a second button 33 of a communication button The second button may be used to trigger establishment of a connection to another device, or to trigger a transmission of information to another device.
  • a third button 34 is a confirmed or ok button. The third button 34 can be used to acknowledge information presented to a user of supplemental device 2.
  • Fig. 5a and Fig. 5b show an injection device 1 and a supplemental device 2 (separately or attached respectively).
  • the supplemental device comprises at least one sensor (not shown) and a housing 20 having a recess (not shown) arranged to receive a protrusion (not shown) provided on the injection device.
  • the supplemental device 2 is provided with a clip arrangement comprising two flexible arms 51 arranged so as to be received by a circumferential recess 52 provided on the injection device.
  • the injection device 1 comprises code (not shown) and a circumferential recess 52 arranged to receive the flexible arms 51 provided on the supplemental device.
  • the circumferential recess 52 provided on the injection device 1 receives the two flexible arms 51 provided on the supplemental device 2 such that the sensor (not shown) provided on the supplemental device 2 is axially aligned (in relation to an axis running the length of the injection device) with the code (not shown) provided on the injection device 1 .
  • the supplemental device 2 comprises a hollow cylindrical section 53 into which the injection device 1 will fit. The injection device 1 can be inserted into the hollow cylindrical section 53 of the supplemental device 2 by sliding the injection device 1 dosage knob end 54 first (as shown by the arrow in Fig. 5a). Once inserted to the required extent, the flexible arms 53 will engage with the circumferential recess 52 and the sensor provided in the supplemental device 2 is axially aligned with the code provided on the injection device 1 .
  • Fig. 6 illustrates a supplemental device 2 having a recess 61 arranged to receive a protrusion 62 provided on the injection device 1 .
  • the protrusion 62 provided on the injection device 1 is a code access aperture in the form of a
  • the window/lens and the recess 61 provided on the supplemental device 2 is arranged so as to receive the lens 62.
  • the recess 61 extends between one end of the hollow cylindrical section 53 of the supplemental device 2 and the protrusion/code access aperture 62 provided on the injection device 1 .
  • dosage knob end 54 As the injection device 1 is inserted dosage knob end 54 first into the hollow cylindrical section 53 of the supplemental device 2 the protrusion 62 engages with the recess 61 .
  • the recess 61 is arranged such that when it receives the protrusion 62 provided on the injection device, a sensor (not shown) provided on the supplemental device 2 is rotationally aligned (in relation to an axis running the length of the injection device) with the code (not shown) provided on the injection device 1 .
  • the supplemental device 2 also comprises flexible arms (not shown) arranged so as to engage with the circumferential recess 52 provided on the injection device 1 .
  • a sensor (not shown) provided on the supplemental device 2 is axially aligned with the code (not shown) provided on the injection device 1 .
  • the protrusion 62 is a window/lens through which code can be read.
  • the protrusion 62 is engaged with the recess 61 and the circumferential recess 52 is receiving flexible arms 51 .
  • a sensor (not shown) provided on the supplemental device 2 is both axially and rotationally aligned with the code (not shown) provided on the injection device 1 .
  • Fig. 7 shows a different perspective of the same embodiment illustrated in Fig. 6.
  • the supplemental device 2 comprises two flexible arms 51 engaged with a circumferential recess 52 provided on the injection device 1 .
  • the circumferential recess 52 provided on the injection device 1 and the flexible arms 51 provided on the supplemental device 2 are arranged such that when the flexible arms 51 are engaged with the circumferential recess 52, a sensor (not shown) provided on the supplemental device 2 is axially aligned with the code (not shown) provided on the injection device 1 .
  • Fig. 8 illustrates a different perspective of the supplemental device 2 shown in Figs. 6 and 7.
  • the device 2 has a hollow cylindrical section 53 into which an injection device (not shown) can be received.
  • the supplemental device 2 has a recess 61 that is arranged to receive a protrusion provided on the injection device. As described in relation to Figs. 6 and 7, the protrusion may be a window/lens through which code provided on the injection device can be read.
  • the supplemental device 2 also has two flexible arms 51 arranged to engage with a circumferential recess (not shown) provided on an injection device. The flexible arms 51 are provided at one end of the hollow cylindrical section 53 of the supplemental device 2.
  • the flexible arms 51 are located on the opposite sides of the circumference of the hollow cylindrical section 53 of the supplemental device 2.
  • the injection device is inserted into the hollow cylindrical section 53 of the supplemental device 2.
  • a protrusion provided on the injection device (not shown) engages with the recess 61 and the flexible arms 51 engage with a circumferential recess provided on the injection device (not shown).
  • the protrusion, the recess 61 , the flexible arms 51 , and the circumferential recess are arranged so that when the supplemental device 2 is attached to the injection device, a sensor (not shown) on the supplemental device 2 is axially and rotationally aligned with code provided on the injection device (not shown).
  • Fig. 9 illustrates an alternative embodiment of the invention in which the injection device 1 is assembled cartridge end 91 first into the cylindrical hollow section 53 of the supplemental device 2 (see arrow in Fig 9).
  • the supplemental device 2 also has two flexible arms 51 which when attached (not shown) to the injection device 1 are engaged with the circumferential recess 51 provided on the injection device 1 such that a sensor (not shown) provided by supplemental device 2 is axially aligned with the code (not shown) provided on the injection device 1 .
  • Fig. 10 illustrates a supplemental device 2 and an injection device 1 shown in a state where the supplemental device 2 is engaged with the injection device 1 ready for use.
  • the supplemental device 2 has a recess 61 arranged to receive a protrusion 62 provided on the injection device 1 .
  • the protrusion 62 is a lens/window through which can be seen a number scale providing information regarding the dialled dose volumes.
  • the recess 61 extends through the entire width of the housing 20 forming a slot through which the lens/window 62 is still visible to the user when the supplemental device 2 has been attached to the injection device 1 .
  • the injection device comprises additional code (not shown) that is read by the sensor (not shown) of the supplemental device 2.
  • the sensor of the supplemental device 2 is rotationally aligned with the additional code (not shown) provided on the injection device 1 .
  • the supplemental device further comprises flexible arms 51 arranged to engage with a circumferential recess 52 provided on the injection device 1 . As shown in Fig.
  • a sensor (not shown) provided on the supplemental device 2 is also axially aligned with the additional code (not shown) provided on the injection device 1 .
  • a sensor (not shown) provided on the supplemental device 2 is both axially and rotationally aligned with the additional code (not shown) provided on the injection device 1 .
  • Fig. 1 1 illustrates an injection device 1 that has no lens on the body of said injection device.
  • the supplemental device 2 has two flexible arms 51 arranged on opposite sides of the circumference of a hollow cylindrical section 53 of the supplemental device 2.
  • the injection device 1 is inserted into the hollow cylindrical section 53 of the supplemental device 2 injection end 91 first.
  • the injection device 1 has two corresponding local discrete recesses 1 1 1 arranged to receive the flexible arms 51 provided on the supplemental device 2.
  • the local recesses 1 1 1 and the flexible arms 51 are arranged such that when the flexible arms engage with the local recesses the sensor (not shown) provided on the supplemental device 2 is axially and rotationally aligned with the code (not shown) provided on the injection device 1 .
  • Fig. 12 illustrates an injection device 1 having a protrusion arranged to engage with a recess provided on a supplemental device (not shown).
  • the protrusion is arranged to engage with a recess provided on a supplemental device (not shown).
  • a code access aperture 121 through which the code provided on the injection device 1 can be read by a sensor provided in a supplemental device (not shown).
  • the code access aperture 121 is further provided with a male feature 122 around said aperture arranged to engage with a recess provided on the supplemental device (not shown) such that the supplemental device is correctly aligned with the injection device 1 .
  • the features that directly relate to the point of interaction between the sensor (not shown) on the supplemental device and the code (not shown) provided on the injection device are employed as the protrusion, rather than a separate
  • FIG 13 illustrates a supplemental device 2 and an injection device 1 in which the supplemental device 2 has a recess 61 arranged to receive a protrusion (not shown) provided on the injection device 1 such that when the protrusion (not shown) is engaged with recess 61 , a sensor (not shown) provided on the supplemental device 2 is
  • the supplemental device 2 is attached to the injection device 1 by pushing the injection device into a partly cylindrical hollow space 133 provided by the housing 134 of the supplemental device 2 (see arrow in Fig, 13).
  • the supplemental device 2 has flexible arms 132 which during insertion deflect away from the hollow space 133 that receives the injection device 1 to allow assembly. The flexible arms 132 then return to the at- rest-position, to retain the injection device 1 .
  • the supplemental device 2 provides an internal recess 61 arranged to receive a protrusion (not shown) provided on the injection device 1 . When the protrusion (not shown) is engaged with the recess 61 , a sensor (not shown) on the supplemental device is rotationally aligned to code (not shown) on the injection device 1 .
  • the supplemental device 2 contains a sensor (not shown) which is then able to read and interpret the code (not shown) provided through the lens on the device and to gather information regarding for example dialled dose volume.
  • the supplemental device 2 is axially aligned to the injection device 1 by revolved protrusions 131 at either end of the housing forming the partly cylindrical hollow space 133 provided by the supplemental device 2, which engage with corresponding circumferential recesses 52 provided on the injection device 1 as shown in Fig. 14.
  • Fig. 15 shows a different perspective of the same embodiment illustrated in Figs. 13 and 14.
  • the supplemental device 2 has a recess 61 arranged to receive a protrusion (not shown) provided on an injection device (not shown).
  • the supplemental device 2 also contains revolved protrusions 131 at either end of the supplemental device arranged to engage with corresponding circumferential recesses provided on the injection device.
  • the supplemental device 2 also has a set of flexible arms 132 which deflect away from the injection device (not shown) as the supplemental device 2 is pushed on to the injection device (not shown); the flexible arms 132 then return to the at-rest-position, to retain the injection device.
  • Fig. 16 shows an alternative arrangement in which two protrusions 62 on the injection device 1 are used to align the supplemental device (not shown) to the injection device 1 .
  • the supplemental device (not shown)
  • a benefit to using alternative features, rather than the lens 161 provided on the injection device 1 , to align the injection device 1 with the supplemental device 2, is that the injection device 1 could be assembled to the supplemental device 2, with the lens 161 facing out, visible to the user. This means the user could still use a standard number scale (not shown) through the lens 161 when dialling and dispensing.
  • Fig. 18 illustrates an embodiment in which the supplemental device 2 is required to interface (via a sensor - not shown) with code (not shown) provided on the injection device 1 to determine dialled dose volume.
  • the optical sensor (not shown) on the supplemental device 2 is required to align with the code access aperture 121 in order to read the code (not shown) provided on the injection device 1 .
  • Fig. 18 shows an example of how a male feature 122 on the injection device 1 , which has a direct relationship with the aperture 121 , can be used to align the sensor of the supplemental device 2 with the code of the injection device 1 .
  • Fig. 19 illustrates an injection device 1 having conductive code 191 .
  • a conductively coded injection device such as shown in Fig. 19 requires contacts on the supplemental device (not shown) to form an electrical connection with the code 191 .
  • Unique female slots 192 on the injection device 1 as shown in Fig. 19, can be used to engage with a protrusion provided on the supplemental device (not shown) so as to align the sensor (not shown) on the supplemental device 2 with the code 191 .
  • Both optically and conductively coded injection devices require apertures in the injection device housing to allow the supplemental device to read the code.
  • the code access aperture not be accessible. This is to ensure dirt and other alien objects are not inserted into the injection device, which may hinder the dispense mechanism.
  • Fig. 20 illustrates a first option for protecting the code provided on an injection device 1 in which a tear-off tag 201 is used to cover the code access aperture (not shown).
  • the tag 201 can be removed to reveal the code access aperture before the supplemental device (not shown) is attached to the injection device 1 .
  • Figs. 21 and 22 illustrate alternative embodiments for covering the code access aperture prior to attachment of a supplemental device to an injection device. Both Figs. 21 and 22 illustrate embodiments in which a perforated label 214 is employed over the code access aperture 213.
  • the label has perforated sections 21 1 which enclose the portion of the label 214 that requires removal to allow access to the code aperture 213.
  • Fig. 21 shows how a protruding feature 212 on the supplemental device 2 can be used to pierce the label 214 and move it to one side, such that the aperture 213 is not blocked. This arrangement is ideally suited to supplemental devices described in Figs. 13 and 18 above.
  • Fig. 21 shows how a protruding feature 212 on the supplemental device 2 can be used to pierce the label 214 and move it to one side, such that the aperture 213 is not blocked. This arrangement is ideally suited to supplemental devices described in Figs. 13 and 18 above.
  • FIG. 22 shows a protruding feature 221 located on a sprung arm 222 on the supplemental device 2 which pierces the label 214 and then peels it away from the code access aperture 213.
  • This arrangement is ideally suited for supplemental devices and injection devices illustrated in Figs. 5 to 12 above.
  • the protruding feature 212, 221 is configured to engage with the access aperture 213. This helps to align the
  • the protruding feature engages with the access aperture, this helps to circumferentially/rotationally fix the supplemental device relative to the injection device. In other words, this helps to fix the supplemental device relative to the injection device and prevent relative rotation between the two devices.
  • the protruding feature is configured to abut the code access aperture, thereby axially fixing the supplemental device relative to the injection device.
  • the supplemental device is axially fixed at least in one direction, e.g. along the length axis of the injection device.
  • the width of the protruding feature is adapted to fit the width of the code access aperture, such that the protruding feature abuts the code access aperture along two or three borders, when the
  • the protruding feature is configured to abut the code access aperture along three borders.
  • Fig. 23 the situation is shown for the embodiment of Fig. 21 .
  • the code access aperture 213 is indicated with a dashed line on the right hand side.
  • the protruding feature 212 is indicated by a solid line.
  • the part of label 214 that is pushed aside has been omitted for clarity reasons.
  • the protruding feature 221 abuts the lower edge of aperture 213 crushing the peeled part of label 214.
  • the protruding feature is adapted to fit the code access aperture it will further abut the left and right edge of the aperture.
  • the protruding feature 212 engaging with the code access area 213 provides an attachment means the helps finding the right position of the supplemental device before attaching, ensuring proper positioning during attachment, and holding the supplemental device in place while being attached to allow reliable reading of the code of the encoded injection device.
  • the protruding feature 212 on the supplemental device 2 can be used to pierce the label 214 and move it to one side, such that the aperture 213 is not blocked. Fig. 21 showing the steps before and just after the label is pierced.
  • protruding feature 212 When the supplemental device 2 is attached to the injection device 1 , protruding feature 212 has fully entered the code access aperture 213 (Fig. 23 left hand side), and the label 214 is moved to one side. The code access aperture 213 is not blocked and a sensor (not shown) is then aligned with the code accessible through the code access aperture 213.
  • the code is optical code, such as optical gray code and the sensor is an optical sensor.
  • the optical sensor is arranged behind the protruding feature 212 opposite to the code access area 213.
  • the protruding feature 212 preferably is made of material that allows the optical sensor to see through it.
  • the protruding feature is made of optically transparent material, such as polycarbonate, acryl, or glass.
  • the protruding feature may be designed as a hollow element having an open channel that provides that the optical sensor has access to the optical code through the hollow open channel of the protruding element and the code access aperture.
  • the protruding feature is further configured as a light guide.
  • a light is required to enable optical code detection.
  • the light could come from various sources. It may simply be ambient light, there could be a light source in the injection device, or there could be a light source in the supplemental device. Having the light source in the supplemental device would be beneficial, because the light source could be operated in coordination with the optical sensor. Having the protruding feature configured as a light guide reduces complexity of the supplemental device. Because no separate element is required to provide light to the code access are.
  • the protruding feature 212 provides several functions that however each add to a synergistic effect when the supplemental device is attached to the injection device:
  • the protruding feature 212 additionally provides the function to guide light to the code.

Abstract

La présente invention concerne un dispositif de surveillance auxiliaire (2) pour fixation amovible à un dispositif d'injection de médicament de type stylo (1), le dispositif supplémentaire comprenant un capteur pour détecter un codage sur le dispositif d'injection de médicament qui représente une quantité de dose réglée et/ou injectée, et un boîtier ayant un évidement (61) agencé pour recevoir une saillie (62) disposée sur la surface externe du dispositif d'injection, dans lequel, lorsque l'évidement du dispositif supplémentaire est engagé avec la saillie du dispositif d'injection, le dispositif supplémentaire et donc son capteur sont tous deux rigidement alignés, à la fois en rotation et axialement, avec le dispositif d'injection et donc son codage pour représenter la dose. Lors de la fixation du dispositif de surveillance au dispositif d'injection, un élément saillant transparent ou creux (212) sur le boîtier du premier enlève simultanément une étiquette perforée (214) sur le second d'une ouverture (213), afin de permettre l'accès du capteur au codage.
PCT/EP2014/050463 2013-01-15 2014-01-13 Dispositif d'injection de médicament de type stylo et module de surveillance auxiliaire électronique pour surveiller et enregistrer le réglage et l'administration de dose WO2014111336A1 (fr)

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JP2018506363A (ja) * 2015-02-27 2018-03-08 ノボ・ノルデイスク・エー／エス 取り付け安全特徴を有するアクセサリ装置
WO2017081051A1 (fr) * 2015-11-11 2017-05-18 Novo Nordisk A/S Dispositif d'administration de médicament avec capture d'informations
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CN108697857A (zh) * 2015-12-10 2018-10-23 赛诺菲-安万特德国有限公司 具有可移除地附接的传感器装置的药物输送装置
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US10967133B2 (en) 2016-05-30 2021-04-06 Novo Nordisk A/S Mounting feature for accessory device
US11464912B2 (en) 2016-05-30 2022-10-11 Novo Nordisk A/S Drug delivery device with zero position adjustment feature
US11596747B2 (en) 2017-09-22 2023-03-07 Novo Nordisk A/S Accessory device for drug delivery device
WO2019097191A1 (fr) * 2017-11-20 2019-05-23 Gilson Sas Accessoire fonctionnalise pour pipette mecanique de prelevement
FR3073755A1 (fr) * 2017-11-20 2019-05-24 Gilson Sas Accessoire fonctionnalise pour pipette mecanique de prelevement
CN111278566A (zh) * 2017-11-20 2020-06-12 吉尔松有限合伙公司 机械式采样移液管的功能附件
JP2021503365A (ja) * 2017-11-20 2021-02-12 ジルソン エスアーエス 機械的なサンプリングピペットのための機能化されたアクセサリ
JP7194731B2 (ja) 2017-11-20 2022-12-22 ジルソン エスアーエス 機械的なサンプリングピペットのための機能化されたアクセサリ
US11684722B2 (en) 2017-12-04 2023-06-27 Novo Nordisk A/S Drug delivery system with multipolar magnet and sensor system

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