EP4688049A1 - A drug container enclosure with an rfid label - Google Patents

A drug container enclosure with an rfid label

Info

Publication number
EP4688049A1
EP4688049A1 EP24710459.9A EP24710459A EP4688049A1 EP 4688049 A1 EP4688049 A1 EP 4688049A1 EP 24710459 A EP24710459 A EP 24710459A EP 4688049 A1 EP4688049 A1 EP 4688049A1
Authority
EP
European Patent Office
Prior art keywords
medicament
drug container
rfid label
container enclosure
marks
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24710459.9A
Other languages
German (de)
French (fr)
Inventor
Rasmus RENSTAD
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SHL Medical AG
Original Assignee
SHL Medical AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by SHL Medical AG filed Critical SHL Medical AG
Publication of EP4688049A1 publication Critical patent/EP4688049A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • GPHYSICS
    • G06COMPUTING OR CALCULATING; COUNTING
    • G06KGRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
    • G06K19/00Record carriers for use with machines and with at least a part designed to carry digital markings
    • G06K19/06Record carriers for use with machines and with at least a part designed to carry digital markings characterised by the kind of the digital marking, e.g. shape, nature, code
    • G06K19/067Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components
    • G06K19/07Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components with integrated circuit chips
    • G06K19/077Constructional details, e.g. mounting of circuits in the carrier
    • G06K19/07749Constructional details, e.g. mounting of circuits in the carrier the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card
    • G06K19/07798Constructional details, e.g. mounting of circuits in the carrier the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card part of the antenna or the integrated circuit being adapted for rupturing or breaking, e.g. record carriers functioning as sealing devices for detecting not-authenticated opening of containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • A61M2005/005Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403Ampoule inserted into the ampoule holder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3569Range sublocal, e.g. between console and disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14546Front-loading type injectors

Definitions

  • the present disclosure generally relates to medicament delivery devices, and particularly concerns drug container enclosure for accommodating a medicament container.
  • the medications could be related to advanced treatments in a home-setting, e.g. oncology.
  • the medications and order are determined by the Physician or medical practitioner, which submits the prescription to the Pharmacy. The Pharmacist prepares and packages the medication for the patient. However, state of the art procedure is that the patient needs to identify and correct administer the medication.
  • An objective of the present disclosure is to provide a drug container enclosure for accommodating a medicament container, which solves, or at least mitigates problems of the prior art.
  • a drug container enclosure for accommodating a medicament container, the drug container enclosure comprising: a designated portion comprising a set of marks to indicate positioning for an RFID label, an RFID label attached in the designated portion according to the set of marks, the RFID label comprising processing circuitry and circuit loops each with a circuit path aligned with a respective one mark of the designated portion, wherein penetrating the marks causes rupture of the respective circuit loops.
  • Embodiments of the present disclosure advantageously provides for an information system for medicaments that can be entered by manually penetrating the marks. This relieves the user from, e.g., a patient, from relying on written instructions. Instead, the pharmacist or provider of the medicament can enter the information directly to the RFID label of the drug container enclosure.
  • the marks of the drug container enclosure facilitate positioning of the RFID label. Rupturing of the respective circuit loop is made with less effort due to the design and structure of the marks.
  • distal direction refers to the direction pointing away from the dose delivery site during use of the medicament delivery device.
  • distal part/end refers to the part/end of the delivery device, or the parts/ends of the components thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site.
  • proximal direction refers to the direction pointing towards the dose delivery site during use of the medicament delivery device.
  • proximal part/end refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site.
  • longitudinal refers to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and/or component.
  • transverse refers to a direction generally perpendicular to the longitudinal direction.
  • circumference refers to a circumference or a circumferential direction 301 relative to an axis 102, typically a central axis extending in the direction of the longest extension of the device and/or component.
  • radial or “radially” refer to a direction 302 extending radially relative to the axis
  • rotation refers to rotation relative to the axis.
  • medication information may be readable from the RFID label, where the medication information depends on which respective circuit loop is ruptured.
  • the RFID label may contains predetermined information, such as unique identifier and other information that can be written to the memory of the RFID label. Manipulating the RFID label provides for entering information to the RFID label without the need for a RFID writer system that is validated. Such RFID writer system is expensive and cumbersome to implement.
  • the RFID label may comprise visual labels to guide the pharmacist to penetrate the correct marks for entering the desired medication information.
  • the visual labels assist the user in penetrating the correct marks for entering the intended medication information.
  • the visual labels may be printed on a separate layer of the RFID label that is attached to the circuit layer comprising the circuit loops.
  • a label or tab may be added on top of the RFID label and the visual labels to lock-out the possibility to penetrate and rupture the remaining circuit loops.
  • the medication information may comprise which order the current medicament container has in a present medicament sequence. The order may be if the current medicament container is e.g, the first, second, third, etc. medicament is the current sequence. Thus, the user is assisted in injecting or administering the medicaments in the current order.
  • the drug delivery device may read the RFID label to check whether the correct drug container enclosure is provided.
  • the medication information may advantageously comprise a total number of injections to administer in the present medicament sequence.
  • the marks may comprise a set of holes or voids in the drug container enclosure.
  • By having holes or voids in the material of the drug container enclosure reduces the amount of force needed for penetrating the marks.
  • the tool used for penetrating the marks thereby enters or punctures the holes or voids.
  • the set of marks may comprise a set of weak spots in the drug container enclosure.
  • the weak spots may be of a different material than the rest of the drug container enclosure, such as a void or hole filled with a weaker material that is easier to penetrate than the bulk material of the drug container enclosure.
  • Another embodiment would be label tabs containing circuits that can be teared off.
  • the RFID label may be attached to the drug container enclosure by an adhesive. That is, the RFID label may be a flexible multilayer label that is glued to the drug container enclosure in the designated portion.
  • the drug container enclosure may be mountable in a medicament delivery device comprising an RFID reader.
  • a medicament delivery device configured to receive a drug container enclosure according to any one the herein described embodiments, the medicament delivery device comprising an RFID reader including processing circuitry configured to: read medicament information and compare the read medicament information with on device stored medicament information, and provide an indication of the comparison to a user via a user interface.
  • an RFID label configured to be attached to a drug container enclosure, the RFID label comprising: processing circuitry; and at least one circuit loop, wherein end portions of each circuit loop is electrically connected with the processing circuitry, the circuit loops are configured to be ruptured by penetration of the RFID label by an external tool for entering medicament information, and the processing circuitry is configured to detect whether the circuit loops are complete or ruptured.
  • rupturing of a circuit loop may provide medicament information to the processing circuitry.
  • the RFID label may comprise visual labels to guide a user, i.e., a pharmacist, to penetrate the correct positions for entering the desired medication information.
  • the medication information may comprise which order the current medicament container has in a present medicament sequence.
  • the medication information may comprise a total number of injections to administer in the present medicament sequence.
  • Fig. 1A is a perspective view of a medicament delivery device according to embodiments of the present disclosure
  • Fig. 1B is a perspective view of a medicament delivery device and drug container enclosure according to embodiments of the present disclosure
  • Fig. 2A illustrates a drug container enclosure body according to embodiments of the present disclosure
  • Fig. 2B illustrates a drug container enclosure with an RFID label according to embodiments of the present disclosure
  • Fig. 2C illustrates a drug container enclosure with an RFID label and visual labels according to embodiments of the present disclosure
  • Fig. 3 illustrates a signal level read by the processing circuitry depending on the state of the circuit loops
  • Fig. 4 is an exploded view of drug container enclosure according to embodiments of the present disclosure.
  • Fig. 5 is an exploded view of drug container enclosure according to embodiments of the present disclosure.
  • Fig. 6 schematically illustrates a medicament delivery device configured to receive a drug container enclosure.
  • Fig 1A shows an example of a medicament delivery device 1 such as an autoinjector according to embodiments of the present disclosure.
  • the medicament delivery device 1 is configured to expel medicament from a medicament container via a medicament delivery member such as a needle, to a user at a dose delivery site.
  • the medicament delivery device 1 extends from a proximal end la to a distal end lb relative to the axis 102.
  • the medicament delivery device 1 comprises a housing 3 with a window 4.
  • the housing 3 has a proximal end 3a and a distal end 3b.
  • a needle shield 6 configured to cover a needle extends out from the proximal end 3a of the housing 3.
  • a medicament container is placed inside the housing 3 from which medicament is expelled under the action of a spring-loaded plunger.
  • Fig 1B shows another example of a medicament delivery device 1 such as an autoinjector of an injection device according to embodiments of the present disclosure.
  • the medicament delivery device 100 is configured to expel medicament from a medicament container via a medicament delivery member such as a needle 2, to a user at a dose delivery site.
  • the medicament delivery device 100 extends from a proximal end la to a distal end lb relative to the axis 102.
  • the medicament delivery device 1 comprises a housing 3 and is connectable to a drug container enclosure 4 having a proximal end 4a and a distal end 4b.
  • the drug container enclosure 4, which may be a disposable cassette is in this example connected to an infusion set 7 comprising a flexible tube 8 connected to a through hole of the disposable cassette 4 at the proximal end 4a.
  • the needle 2 attached via a pad 9.
  • the infusion set 7 is optional for embodiments of the present disclosure.
  • the disposable cassette 4 is adapted to accommodate a medicament container which can be of different volumes, for example ranging from about 1 ml to about 10 ml.
  • the medicament delivery device 1 comprises a receiving interface 11 configured to received and lock the disposable cassette to the proximal end la of the medicament delivery device 1.
  • the drug container enclosure 4 is adapted for accommodating a medicament container holding a medicament.
  • Autoinjectors and other types of products for delivering medicaments to a user provide efficient means for administrating the medicaments.
  • a new level of complexity is added.
  • the user involvement increases to make sure the medicaments are injected, or administered, in the correct order.
  • the most common solution is in state of the art is to communicate the drug delivery sequence to the user through oral, and/or written instructions and labelling.
  • this solution relies on the user being able to correctly interpret and execute the instructions correctly.
  • One advantage of the proposed solution is it does not require patients to rely on instructions, Pharmacies to design IT system with API’s that communicate drug type and sequence remotely to drug delivery systems (from different manufacturers), or personnel to directly program the device system.
  • the latter would require the patient to send or bring the system to the pharmacy before each administration round.
  • the former would require that the device system and pharmacy backend have reliable remote communication, wired or wireless.
  • Fig. 2A schematically illustrates a drug container enclosure 10.
  • the drug container enclosure io is adapted for accommodating a medicament container holding a medicament.
  • the drug container enclosure io may be provided in various forms such as e.g., a box, a plastic container, or as a disposable cassette 4 shown in fig. 1B, etc, that holds a medicament container.
  • the drug container enclosure 10 comprises a designated portion 12 comprising a set of marks 14 (only one is numbered) to indicate positioning for an RFID label.
  • the drug container enclosure 10 comprises six marks 14.
  • the marks 14 may comprise a set of holes or voids in the drug container enclosure 10. That is, pre-made holes or voids in the bulk material of the drug container enclosure 10 may form the marks.
  • the marks may further comprise a visual indication of the location of the hole of void.
  • the set of marks 14 may comprises a set of weak spots in the drug container enclosure 10.
  • the weak spots are penetrable by a force for example sticking a pen in the mark by hand by a user, i.e., a pharmacist.
  • the drug container enclosure 10 further comprises an RFID label 16 attached in the designated portion 12 according to the set of marks 14.
  • the RFID label comprising processing circuitry 18 and circuit loops 20 each with a circuit path aligned with a respective one mark 14 of the designated portion 12.
  • the enclosure 10 without the RFID label 16 is added to shown how the circuit loops 20 are aligned with the marks 14.
  • the alignment between the marks 14 and the respective circuit loop 20 is such that if the marks 14 are penetrated from the layer of the RFID label 16, the respective circuit loop 20 is ruptured. Thus, penetrating the marks 14 causes rupture of the respective circuit loops 20.
  • Fig. 2C illustrates the drug container enclosure 10 with the RFID label 16, but here also equipped with visual labels 22 to guide a user, such as a pharmacist, to penetrate the correct marks 14 for entering the desired medication information.
  • the labels include, in the bottom row, which order the current medicament container has in a present medicament sequence, and in the upper row comprises a total number of injections to administer in the present medicament sequence.
  • the pharmacist penetrates the correct marks 14 according to the labels 22 to enter the number of injections and the order in the injection sequence for each medicament container.
  • the drug container enclosure 10 is mountable in a medicament delivery device comprising an RFID reader.
  • the medication information is readable from the RFID label 16, where the medication information depends on which respective circuit loop 20 is ruptured.
  • the processing circuitry evaluates, when powered, whether the circuit loops are complete or are ruptured. Depending on whether the circuit loop is connected or not, that is, whether it is complete or not, the processing circuitry reads a different resistance or voltage which also results in a different signal, i.e., high or low, or 1 or o.
  • Fig. 3 illustrates a signal read by the processing circuitry 18 depending on the state of the circuit loops 20.
  • Each of the loops here denoted A-F is associated with a piece of medication information.
  • circuit loops A, B, C refer to the number of total injections, for example one, two, and three respectively.
  • circuit loops E, F, G may refer to which order in the sequence a specific medication is to be administered, that is, first, second, or third, respectively. If a circuit loop is ruptured, a high signal, digital 1, is registered, and if a circuit loop is complete, a low signal, a digital o, is registered.
  • the medication information would be that the total number of injections in the present sequence is 3, and the present medication is the second one in that sequence.
  • the RFID label 16 is read by the medicament delivery device, this information is received and can be checked against previous injections to make sure the correct medication, in the present sequence, is being loaded in the medicament delivery device.
  • Fig. 4 is an exploded view of a drug container enclosure 10.
  • the drug container enclosure comprises the designated portion 12 on a body 25 of the drug container enclosure 10.
  • the set of marks 14 that may be provided as voids, holes, or weak spots that are penetrable by a pointy tool.
  • the RFID label 16 is attached to the drug container enclosure body 25, for example by an adhesive.
  • the RFID label 16 is attached to the designated portion 12 which is the bottom layer.
  • the RFID label 16 comprises the processing circuitry 18 and the circuit loops 20 that are electrically connected with the processing circuitry 18.
  • the circuit loops 20 reach to the marks 14 so that a portion of the circuit loops are aligned with the marks.
  • the processing circuitry 18 is configured to detect whether the circuit loops are complete or ruptured.
  • visual labels 22 are arranged, either as part of the RFID label, that is, printed on the RFID label, or as a separate layer attached to the RFID label 16.
  • the labels 22 guide a pharmacist to penetrate the correct positions for entering the desired medication information.
  • the labels 22 typically include written information to instruct the user.
  • the circuit loops 20 are shown as planar circuits that lay in a horizontal plane, i.e., in a single plane parallel with the main plane of the RFID label 16. In other possible embodiments, the circuit loops may be dual plane circuit loops with a vertical connection.
  • Fig. 5 illustrates a possible sequence for using embodiments of the present disclosure.
  • a drug container enclosure io is provided as described above.
  • a user typically a pharmacist or similar, uses a pointy tool 27 to penetrate the correct marks 14 based on which medicament information is desired to enter and as guided by visual labels 22.
  • the visual labels 22 are in the top layer and the marks 14 are in the bottom layer, the RFID label is sandwiched between the marks 14 and the visual labels 22.
  • the total number of containers is 2 and the present container 10 is the first in the sequence.
  • Penetration of the marks 14 causes the circuit loops 20 corresponding to that the total number of containers is 2 and that the present container 10 is the first in the sequence.
  • the processing circuitry 18 of the RFID label 16 has access to instructions that a given circuit loop corresponds to a given piece of medicament information.
  • Fig. 6 illustrates a medicament delivery device 30 configured to receive a drug container enclosure 10.
  • the medicament delivery device which may be or various kinds and is not limited to autoinjectors, comprises an RFID reader 32 including processing circuitry 34 configured to read medicament information from the RFID label 16.
  • the processing circuitry 34 thus reads information of which order the present container is in the present sequence of medication, and the total number of injections in the present sequence.
  • the processing circuitry 34 can compare the read medication information to stored medicament information, for example related to the prior administered injection, or to compare a unique identifier of the present container with prestored IDs related to the drug to be administered, and to make sure that same container is not inserted twice.
  • the processing circuitry 34 provides an indication of the comparison to a user via a user interface 36.
  • the user interface 36 may be for example an audio, a visual, or a haptic interface.
  • the device 30 can read out whether the inserted container 10 is in the correct order versus the information given by the label and comparing to data from previous injections processed and stored locally in the device 30 system.
  • Embodiments of the present disclosure may be applied to various medicament delivery devices.
  • the medicament delivery maybe an autoinjector.
  • a medicament delivery device may generally include various other components.
  • a sensor unit which may recognize medicament delivery events, such as the needle inserted into an attachment portion of e.g., a pad, injection started, and medicament delivery operation ends
  • a memory unit which is configured to store the recorded data during the medicament delivery operation
  • a connectivity unit configured to transmit the stored data to a smart device or the network directly
  • a processing unit configured to control the entire system and processes the data before transmitting it
  • user interface units that are configured to provide feedback to the patient, such as status LEDs, haptic, and/or audio feedback.
  • the sensors inside of the pad are configured to recognize the event and give feedback to the patient via haptic/visual or audio elements.
  • the sensors are configured to recognize the event and give feedback to the patient again. Further, the collected data is stored in the memory unit and may be transmitted to the smart device/ network via the connectivity unit after the medicament delivery event finishes.
  • the sensor can be one of or the combination of the following: a mechanical switch, a Hall-effect sensor, an accelerometer.
  • the mechanical switch, hall-effect sensor, or accelerometer can be used for detection of the insertion of a needle into an injection port.
  • the accelerometer can be used for detecting medicament delivery events.
  • Possible wireless communication methods include Bluetooth and Cellular Networks.
  • Bluetooth connectivity requires a smart device to transmit the stored data to the network and it requires a pairing action between the pad and the smart device before being able to use the supporting pad in case of 2-way connection. But it’s a cheaper alternative and it requires less space on PCB. A l-way connection does not require pairing.
  • the cellular network does not require any pairing process, it can be used as a plug-n-play device, no prior setup is needed, but it’s more expensive and it requires more space on PCB.
  • processing units or processing circuitry may comprise a logic circuit or control unit including a microprocessor, microcontroller, programmable digital signal processor or another programmable device.
  • the processing circuitry may also, or instead, each include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor.
  • the processing circuitry includes a programmable device such as the microprocessor, microcontroller or programmable digital signal processor mentioned above, the processor may further include computer executable code that controls operation of the programmable device.
  • the medicament delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders.
  • exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies.
  • Exemplary types of drugs that could be included in the medicament delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, and/or protein derivatives.
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g.
  • evolocumab hypercholesterolaemia
  • exenatide type 2 diabetes
  • secukinumab psoriasis
  • erenumab mimerase
  • alirocumab rheumatoid arthritis
  • methotrexate amethopterin
  • tocilizumab rheumatoid arthritis
  • interferon beta-ia multiple sclerosis
  • sumatriptan miraines
  • adalimumab rheumatoid arthritis
  • darbepoetin alfa anaemia
  • belimumab lupus
  • peginterferon beta-ia' multiple sclerosis
  • sarilumab rheumatoid arthritis
  • semaglutide type 2 diabetes, obesity
  • dupilumab atopic dermatitis, asthma, nasal polyps, allergies
  • glucagon glucagon
  • compositions including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier.
  • Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Microelectronics & Electronic Packaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Computer Hardware Design (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Theoretical Computer Science (AREA)
  • Diabetes (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The present disclosure generally relates to medicament delivery devices such as autoinjectors or infusers, and particularly concerns drug container enclosure (10) for accommodating a medicament container.

Description

A DRUG CONTAINER ENCLOSURE WITH AN RFID LABEL
TECHNICAL FIELD
The present disclosure generally relates to medicament delivery devices, and particularly concerns drug container enclosure for accommodating a medicament container.
BACKGROUND
A number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and infusion devices for large volume injections. Although many of these devices have enabled major improvements in the management of a number of medical conditions, various limitations do still exist in the current technology. Not least amongst these are the difficulties faced by patients that require frequent. In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, for example concerning multi-medication scenarios where it is important that the medications are administered in a predetermined order, which are set out in more detail below. The medications could be related to advanced treatments in a home-setting, e.g. oncology. The medications and order are determined by the Physician or medical practitioner, which submits the prescription to the Pharmacy. The Pharmacist prepares and packages the medication for the patient. However, state of the art procedure is that the patient needs to identify and correct administer the medication.
SUMMARY
An objective of the present disclosure is to provide a drug container enclosure for accommodating a medicament container, which solves, or at least mitigates problems of the prior art.
According to a first aspect of the present disclosure, there is provided a drug container enclosure for accommodating a medicament container, the drug container enclosure comprising: a designated portion comprising a set of marks to indicate positioning for an RFID label, an RFID label attached in the designated portion according to the set of marks, the RFID label comprising processing circuitry and circuit loops each with a circuit path aligned with a respective one mark of the designated portion, wherein penetrating the marks causes rupture of the respective circuit loops.
Embodiments of the present disclosure advantageously provides for an information system for medicaments that can be entered by manually penetrating the marks. This relieves the user from, e.g., a patient, from relying on written instructions. Instead, the pharmacist or provider of the medicament can enter the information directly to the RFID label of the drug container enclosure.
The alternative to electronically write sequence order directly into the RFID chip would require that Pharmacies would have invested in the hardware and software capabilities. The high investment cost for such a system and its validation would be very high and hard to motivate for specific device use.
Furthermore, the marks of the drug container enclosure facilitate positioning of the RFID label. Rupturing of the respective circuit loop is made with less effort due to the design and structure of the marks.
In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the components thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site. Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and/or component.
Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.
Further, the terms “circumference”, “circumferential”, “circumferentially” refer to a circumference or a circumferential direction 301 relative to an axis 102, typically a central axis extending in the direction of the longest extension of the device and/or component. Similarly, “radial” or “radially” refer to a direction 302 extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.
According to one embodiment, medication information may be readable from the RFID label, where the medication information depends on which respective circuit loop is ruptured. Advantageously, the RFID label may contains predetermined information, such as unique identifier and other information that can be written to the memory of the RFID label. Manipulating the RFID label provides for entering information to the RFID label without the need for a RFID writer system that is validated. Such RFID writer system is expensive and cumbersome to implement.
According to one embodiment, the RFID label may comprise visual labels to guide the pharmacist to penetrate the correct marks for entering the desired medication information. Advantageously, the visual labels assist the user in penetrating the correct marks for entering the intended medication information. The visual labels may be printed on a separate layer of the RFID label that is attached to the circuit layer comprising the circuit loops.
In some implementations, a label or tab may be added on top of the RFID label and the visual labels to lock-out the possibility to penetrate and rupture the remaining circuit loops. According to one embodiment, the medication information may comprise which order the current medicament container has in a present medicament sequence. The order may be if the current medicament container is e.g, the first, second, third, etc. medicament is the current sequence. Thus, the user is assisted in injecting or administering the medicaments in the current order. The drug delivery device may read the RFID label to check whether the correct drug container enclosure is provided.
According to one embodiment, the medication information may advantageously comprise a total number of injections to administer in the present medicament sequence.
According to one embodiment, the marks may comprise a set of holes or voids in the drug container enclosure. By having holes or voids in the material of the drug container enclosure reduces the amount of force needed for penetrating the marks. The tool used for penetrating the marks thereby enters or punctures the holes or voids.
According to one embodiment, the set of marks may comprise a set of weak spots in the drug container enclosure. The weak spots may be of a different material than the rest of the drug container enclosure, such as a void or hole filled with a weaker material that is easier to penetrate than the bulk material of the drug container enclosure. Another embodiment would be label tabs containing circuits that can be teared off.
According to one embodiment, the RFID label may be attached to the drug container enclosure by an adhesive. That is, the RFID label may be a flexible multilayer label that is glued to the drug container enclosure in the designated portion.
According to one embodiment, the drug container enclosure may be mountable in a medicament delivery device comprising an RFID reader.
According to a second aspect, there is provided a medicament delivery device configured to receive a drug container enclosure according to any one the herein described embodiments, the medicament delivery device comprising an RFID reader including processing circuitry configured to: read medicament information and compare the read medicament information with on device stored medicament information, and provide an indication of the comparison to a user via a user interface.
Further effects and features of the second aspect of the present disclosure are largely analogous to those described above in connection with the first aspect of the present disclosure.
According to a third aspect, there is provided an RFID label configured to be attached to a drug container enclosure, the RFID label comprising: processing circuitry; and at least one circuit loop, wherein end portions of each circuit loop is electrically connected with the processing circuitry, the circuit loops are configured to be ruptured by penetration of the RFID label by an external tool for entering medicament information, and the processing circuitry is configured to detect whether the circuit loops are complete or ruptured.
According to one embodiment, rupturing of a circuit loop may provide medicament information to the processing circuitry.
According to one embodiment, the RFID label may comprise visual labels to guide a user, i.e., a pharmacist, to penetrate the correct positions for entering the desired medication information.
According to one embodiment, the medication information may comprise which order the current medicament container has in a present medicament sequence.
According to one embodiment, the medication information may comprise a total number of injections to administer in the present medicament sequence.
Further effects and features of the second aspect of the present disclosure are largely analogous to those described above in connection with the first aspect and the second aspect of the present disclosure. Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a/an/the member, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the member, apparatus, component, means, etc., unless explicitly stated otherwise.
BRIEF DESCRIPTION OF THE DRAWINGS
The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:
Fig. 1A is a perspective view of a medicament delivery device according to embodiments of the present disclosure;
Fig. 1B is a perspective view of a medicament delivery device and drug container enclosure according to embodiments of the present disclosure;
Fig. 2A illustrates a drug container enclosure body according to embodiments of the present disclosure;
Fig. 2B illustrates a drug container enclosure with an RFID label according to embodiments of the present disclosure;
Fig. 2C illustrates a drug container enclosure with an RFID label and visual labels according to embodiments of the present disclosure;
Fig. 3 illustrates a signal level read by the processing circuitry depending on the state of the circuit loops;
Fig. 4 is an exploded view of drug container enclosure according to embodiments of the present disclosure;
Fig. 5 is an exploded view of drug container enclosure according to embodiments of the present disclosure; and
Fig. 6 schematically illustrates a medicament delivery device configured to receive a drug container enclosure. DETAILED DESCRIPTION
The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.
Fig 1A shows an example of a medicament delivery device 1 such as an autoinjector according to embodiments of the present disclosure. The medicament delivery device 1 is configured to expel medicament from a medicament container via a medicament delivery member such as a needle, to a user at a dose delivery site. The medicament delivery device 1 extends from a proximal end la to a distal end lb relative to the axis 102.
The medicament delivery device 1 comprises a housing 3 with a window 4. The housing 3 has a proximal end 3a and a distal end 3b. A needle shield 6 configured to cover a needle extends out from the proximal end 3a of the housing 3.
A medicament container is placed inside the housing 3 from which medicament is expelled under the action of a spring-loaded plunger.
Fig 1B shows another example of a medicament delivery device 1 such as an autoinjector of an injection device according to embodiments of the present disclosure. The medicament delivery device 100 is configured to expel medicament from a medicament container via a medicament delivery member such as a needle 2, to a user at a dose delivery site. The medicament delivery device 100 extends from a proximal end la to a distal end lb relative to the axis 102.
The medicament delivery device 1 comprises a housing 3 and is connectable to a drug container enclosure 4 having a proximal end 4a and a distal end 4b. The drug container enclosure 4, which may be a disposable cassette is in this example connected to an infusion set 7 comprising a flexible tube 8 connected to a through hole of the disposable cassette 4 at the proximal end 4a. At the other end of the tube 8 is the needle 2 attached via a pad 9. The infusion set 7 is optional for embodiments of the present disclosure.
The disposable cassette 4 is adapted to accommodate a medicament container which can be of different volumes, for example ranging from about 1 ml to about 10 ml.
The medicament delivery device 1 comprises a receiving interface 11 configured to received and lock the disposable cassette to the proximal end la of the medicament delivery device 1.
The drug container enclosure 4 is adapted for accommodating a medicament container holding a medicament.
Autoinjectors and other types of products for delivering medicaments to a user provide efficient means for administrating the medicaments. In case of multi-medicament administration, a new level of complexity is added. Especially, the user involvement increases to make sure the medicaments are injected, or administered, in the correct order. The most common solution is in state of the art is to communicate the drug delivery sequence to the user through oral, and/or written instructions and labelling. However, this solution relies on the user being able to correctly interpret and execute the instructions correctly.
Herein, a drug container enclosure and RFID label is proposed that at least partly alleviates the drawbacks of prior art.
One advantage of the proposed solution is it does not require patients to rely on instructions, Pharmacies to design IT system with API’s that communicate drug type and sequence remotely to drug delivery systems (from different manufacturers), or personnel to directly program the device system. The latter would require the patient to send or bring the system to the pharmacy before each administration round. The former would require that the device system and pharmacy backend have reliable remote communication, wired or wireless.
Fig. 2A schematically illustrates a drug container enclosure 10. The drug container enclosure io is adapted for accommodating a medicament container holding a medicament. The drug container enclosure io may be provided in various forms such as e.g., a box, a plastic container, or as a disposable cassette 4 shown in fig. 1B, etc, that holds a medicament container.
The drug container enclosure 10 comprises a designated portion 12 comprising a set of marks 14 (only one is numbered) to indicate positioning for an RFID label. In this example embodiment, the drug container enclosure 10 comprises six marks 14.
The marks 14 may comprise a set of holes or voids in the drug container enclosure 10. That is, pre-made holes or voids in the bulk material of the drug container enclosure 10 may form the marks. The marks may further comprise a visual indication of the location of the hole of void.
In other embodiments, the set of marks 14 may comprises a set of weak spots in the drug container enclosure 10. The weak spots are penetrable by a force for example sticking a pen in the mark by hand by a user, i.e., a pharmacist.
Turning to fig. 2B, the drug container enclosure 10 further comprises an RFID label 16 attached in the designated portion 12 according to the set of marks 14. The RFID label comprising processing circuitry 18 and circuit loops 20 each with a circuit path aligned with a respective one mark 14 of the designated portion 12. In fig. 2A, the enclosure 10 without the RFID label 16 is added to shown how the circuit loops 20 are aligned with the marks 14.
The alignment between the marks 14 and the respective circuit loop 20 is such that if the marks 14 are penetrated from the layer of the RFID label 16, the respective circuit loop 20 is ruptured. Thus, penetrating the marks 14 causes rupture of the respective circuit loops 20.
Fig. 2C illustrates the drug container enclosure 10 with the RFID label 16, but here also equipped with visual labels 22 to guide a user, such as a pharmacist, to penetrate the correct marks 14 for entering the desired medication information.
In this example, the labels include, in the bottom row, which order the current medicament container has in a present medicament sequence, and in the upper row comprises a total number of injections to administer in the present medicament sequence. In other words, to program the processing circuitry 18 with medication information, the pharmacist penetrates the correct marks 14 according to the labels 22 to enter the number of injections and the order in the injection sequence for each medicament container.
The drug container enclosure 10 is mountable in a medicament delivery device comprising an RFID reader. The medication information is readable from the RFID label 16, where the medication information depends on which respective circuit loop 20 is ruptured.
The processing circuitry evaluates, when powered, whether the circuit loops are complete or are ruptured. Depending on whether the circuit loop is connected or not, that is, whether it is complete or not, the processing circuitry reads a different resistance or voltage which also results in a different signal, i.e., high or low, or 1 or o.
Fig. 3 illustrates a signal read by the processing circuitry 18 depending on the state of the circuit loops 20. Each of the loops, here denoted A-F is associated with a piece of medication information. For the sake of example, let’s assume circuit loops A, B, C, refer to the number of total injections, for example one, two, and three respectively. Further, circuit loops E, F, G may refer to which order in the sequence a specific medication is to be administered, that is, first, second, or third, respectively. If a circuit loop is ruptured, a high signal, digital 1, is registered, and if a circuit loop is complete, a low signal, a digital o, is registered. In this particular example, if the processing circuitry 18 reads the circuit loops 20, the medication information would be that the total number of injections in the present sequence is 3, and the present medication is the second one in that sequence. When the RFID label 16 is read by the medicament delivery device, this information is received and can be checked against previous injections to make sure the correct medication, in the present sequence, is being loaded in the medicament delivery device.
Fig. 4 is an exploded view of a drug container enclosure 10. The drug container enclosure comprises the designated portion 12 on a body 25 of the drug container enclosure 10. In the designated portion 12, the set of marks 14 that may be provided as voids, holes, or weak spots that are penetrable by a pointy tool.
In a separate layer, the RFID label 16 is attached to the drug container enclosure body 25, for example by an adhesive. The RFID label 16 is attached to the designated portion 12 which is the bottom layer. The RFID label 16 comprises the processing circuitry 18 and the circuit loops 20 that are electrically connected with the processing circuitry 18. The circuit loops 20 reach to the marks 14 so that a portion of the circuit loops are aligned with the marks. The processing circuitry 18 is configured to detect whether the circuit loops are complete or ruptured.
In the top layer, visual labels 22 are arranged, either as part of the RFID label, that is, printed on the RFID label, or as a separate layer attached to the RFID label 16. The labels 22 guide a pharmacist to penetrate the correct positions for entering the desired medication information. The labels 22 typically include written information to instruct the user.
In fig. 4, the circuit loops 20 are shown as planar circuits that lay in a horizontal plane, i.e., in a single plane parallel with the main plane of the RFID label 16. In other possible embodiments, the circuit loops may be dual plane circuit loops with a vertical connection. Fig. 5 illustrates a possible sequence for using embodiments of the present disclosure. A drug container enclosure io is provided as described above. A user, typically a pharmacist or similar, uses a pointy tool 27 to penetrate the correct marks 14 based on which medicament information is desired to enter and as guided by visual labels 22. The visual labels 22 are in the top layer and the marks 14 are in the bottom layer, the RFID label is sandwiched between the marks 14 and the visual labels 22.
In this case, the total number of containers is 2 and the present container 10 is the first in the sequence. Penetration of the marks 14 causes the circuit loops 20 corresponding to that the total number of containers is 2 and that the present container 10 is the first in the sequence. The processing circuitry 18 of the RFID label 16 has access to instructions that a given circuit loop corresponds to a given piece of medicament information.
Fig. 6 illustrates a medicament delivery device 30 configured to receive a drug container enclosure 10. The medicament delivery device, which may be or various kinds and is not limited to autoinjectors, comprises an RFID reader 32 including processing circuitry 34 configured to read medicament information from the RFID label 16.
The processing circuitry 34 thus reads information of which order the present container is in the present sequence of medication, and the total number of injections in the present sequence.
The processing circuitry 34 can compare the read medication information to stored medicament information, for example related to the prior administered injection, or to compare a unique identifier of the present container with prestored IDs related to the drug to be administered, and to make sure that same container is not inserted twice.
The processing circuitry 34 provides an indication of the comparison to a user via a user interface 36. The user interface 36 may be for example an audio, a visual, or a haptic interface. Thus, the device 30 can read out whether the inserted container 10 is in the correct order versus the information given by the label and comparing to data from previous injections processed and stored locally in the device 30 system.
Embodiments of the present disclosure may be applied to various medicament delivery devices. In one possible implementation, the medicament delivery maybe an autoinjector.
A medicament delivery device (such as an autoinjector) may generally include various other components. For example, a sensor unit which may recognize medicament delivery events, such as the needle inserted into an attachment portion of e.g., a pad, injection started, and medicament delivery operation ends, a memory unit which is configured to store the recorded data during the medicament delivery operation, a connectivity unit configured to transmit the stored data to a smart device or the network directly, a processing unit configured to control the entire system and processes the data before transmitting it, and/or user interface units that are configured to provide feedback to the patient, such as status LEDs, haptic, and/or audio feedback.
When the medicament delivery device is placed into the attachment portion, the sensors inside of the pad are configured to recognize the event and give feedback to the patient via haptic/visual or audio elements.
When the medicament delivery finishes, the sensors are configured to recognize the event and give feedback to the patient again. Further, the collected data is stored in the memory unit and may be transmitted to the smart device/ network via the connectivity unit after the medicament delivery event finishes.
The sensor can be one of or the combination of the following: a mechanical switch, a Hall-effect sensor, an accelerometer.
The mechanical switch, hall-effect sensor, or accelerometer can be used for detection of the insertion of a needle into an injection port.
The accelerometer can be used for detecting medicament delivery events. Possible wireless communication methods include Bluetooth and Cellular Networks.
Bluetooth connectivity requires a smart device to transmit the stored data to the network and it requires a pairing action between the pad and the smart device before being able to use the supporting pad in case of 2-way connection. But it’s a cheaper alternative and it requires less space on PCB. A l-way connection does not require pairing.
The cellular network does not require any pairing process, it can be used as a plug-n-play device, no prior setup is needed, but it’s more expensive and it requires more space on PCB.
Depending on the requirements of the product any of those two technologies can be used.
Such processing units or processing circuitry may comprise a logic circuit or control unit including a microprocessor, microcontroller, programmable digital signal processor or another programmable device. The processing circuitry may also, or instead, each include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor. Where the processing circuitry includes a programmable device such as the microprocessor, microcontroller or programmable digital signal processor mentioned above, the processor may further include computer executable code that controls operation of the programmable device.
The medicament delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies. Exemplary types of drugs that could be included in the medicament delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, and/or protein derivatives. Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-ia (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-ia' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)). Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.
The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

Claims

1. A drug container enclosure (io) for accommodating a medicament container, the drug container enclosure (io) comprising: a designated portion (12) comprising a set of marks (14) to indicate positioning for an RFID label (16), an RFID label (16) attached in the designated portion (12) according to the set of marks (14), the RFID label (16) comprising processing circuitry (18) and circuit loops (20) each with a circuit path aligned with a respective one mark (14) of the designated portion (12), wherein penetrating the marks (14) causes rupture of the respective circuit loops.
2. The drug container enclosure according to claim 1, wherein medication information is readable from the RFID label (16), where the medication information depends on which respective circuit loop is ruptured.
3. The drug container enclosure according to any one of claims 1 and 2, wherein the RFID label (16) comprises visual labels (22) to guide a user to penetrate the correct marks for entering the desired medication information.
4. The drug container enclosure according to any one of claims 2 and 3, wherein the medication information comprises which order the current medicament container has in a present medicament sequence.
5. The drug container enclosure according to any one of claims 2 and 3, wherein the medication information comprises a total number of injections to administer in the present medicament sequence.
6. The drug container enclosure according to any one of the preceding claims, wherein the marks comprise a set of holes or voids in the drug container enclosure.
7. The drug container enclosure according to any one of the preceding claims, wherein the set of marks comprises a set of weak spots in the drug container enclosure.
8. The drug container enclosure according to any one the preceding claims, wherein the RFID label is attached to the drug container enclosure by an adhesive.
9. The drug container enclosure according to any one the preceding claims, mountable in a medicament delivery device comprising an RFID reader.
10. A medicament delivery device (1, 30) configured to receive a drug container enclosure (10) according to any one the preceding claims, the medicament delivery device comprising an RFID reader (32) including processing circuitry (34) configured to: read medicament information and compare the read medicament information with on device stored medicament information, and provide an indication of the comparison to a user via a user interface.
11. An RFID label (16) configured to be attached to a drug container enclosure, the RFID label comprising: processing circuitry (18); and at least one circuit loop (20), wherein end portions of each circuit loop is electrically connected with the processing circuitry, the circuit loops (20) are configured to be ruptured by penetration of the RFID label by an external tool for entering medicament information, and the processing circuitry is configured to detect whether the circuit loops are complete or ruptured.
12. The RFID label according to claim n, wherein rupturing of a circuit loop provides medicament information to the processing circuitry.
13. The RFID label according to claim 12, wherein the RFID label comprises visual labels to guide a user to penetrate the correct positions for entering the desired medication information.
14. The RFID label according to claim 13, wherein the medication information comprises which order the current medicament container has in a present medicament sequence.
15. The RFID label according to any one of claims 13 and 14, wherein the medication information comprises a total number of injections to administer in the present medicament sequence.
EP24710459.9A 2023-03-28 2024-03-14 A drug container enclosure with an rfid label Pending EP4688049A1 (en)

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US202363455080P 2023-03-28 2023-03-28
EP23177240 2023-06-05
PCT/EP2024/056833 WO2024200030A1 (en) 2023-03-28 2024-03-14 A drug container enclosure with an rfid label

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US7176900B2 (en) * 2002-10-18 2007-02-13 Pitney Bowes Inc. Method and apparatus for field programming radio frequency identification devices
US7876222B2 (en) * 2007-08-30 2011-01-25 Symbol Technologies, Inc. Customizable mechanically programmable RFID tags
GB201218913D0 (en) * 2012-10-22 2012-12-05 Ucb Pharma Sa Auto-injector and drive unit therefor
EP3240200A1 (en) * 2016-04-26 2017-11-01 Novartis Ag Container arrangement including a wireless communication device and method for operating the same

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