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
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/35—Communication
• • 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

Definitions

• the present disclosure relates to the field of add-on devices for injection devices, in particular to add on devices attachable to a pen-type injector.
• the disclosure relates to an injection system comprising an injection device and an add-on device.
• the disclosure relates to a method of configuring an add-on device in the course of assembly to an injection device.
• Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.
• a patient suffering from a particular disease may require a certain amount of a medicament to either be injected via a pen-type injection syringe.
• Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and injecting a dose previously set.
• Other injection devices provide setting and dispensing of a fixed dose.
• the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time.
• an external electronic device such as a mobile electronic device, e.g. implemented as a smartphone, a tablet computer, or a smart watch.
• a software application provided on such external electronic devices may interact with the user and may provide instructions or recommendations to the user of how to correctly use the injection device.
• the short range transceiver of the add-on device establishing or set up of a communication link between the machine-readable identification and the wireless near field transceiver of the add-on device may require a distance less than 5 cm, less than 2 cm, less than 1 cm or even less than 0.5 cm.
• a reading of the machine-readable identification of the injection device is only possible when the add-on device with its device body is suitably fastened to a dedicated portion of the injection device. It is only upon a correct mounting of the add-on device to the injection device that the machine-readable identification can be suitably extracted and processed by the electronic module of the add-on device for configuring or reconfiguring the user perceptible device identification of the add-on device.
• the add-on device comprises both, a wireless near field transceiver and a wireless local range transceiver.
• the add-on device may be operable to obtain and/or read the machine-readable identification of the injection device indirectly, e.g. via or by way of the wireless near field transceiver.
• the wireless local range transceiver the add-on device may communicate with the external electronic device, such as a portable and/or mobile electronic device.
• the electronic device that is operable to read the machine-readable identification of the injection device.
• the respective information is then transmittable to the addon device, e.g. via the communication link between the add-on device and the external electronic device.
• various device identifications or various identifiers may distinguish by at least one of a color, a brightness and/or a temporal variation, e.g. in form of a blinking or flashing light.
• the signals may distinguish by at least one a frequency, a volume and a temporal variation.
• the electronic signal generator may be typically implemented as a kind of a vibration generator, e.g. operable to generate vibration signal that distinguish in strength, vibration frequency and/or by their temporal variation.
• any user perceptible device identification or a respective identifier that can be generated by the electronic signal generator may be characteristic for a particular machine-readable identification of the add-on device. For instance, and for different types of medicaments there may be provided different types of machine-readable identifications on or in the injection device. For each one of these different medicaments there may be provided a unique device identification and/or a respective identifier that distinguish with regard to their color.
• the electronic signal generator comprises at least a first and a second light source, wherein the first and the second light sources are operable to emit light of different colors and/or frequency.
• the electronic signal generator may further comprise a kind of a light guide or an illumination surface optically coupled to the first and second light sources.
• a kind of a light guide or an illumination surface optically coupled to the first and second light sources there may be activated only one of the first and the second light sources or the other one of the first or second light sources, thereby providing identifiers and/or user- perceptible device identifications of different colors.
• respective acoustic signals such as characteristic sounds or jingles that are associated to the characteristics of different injection devices and/or different medicaments to be injected with such devices.
• characteristic haptic signals by way of a vibration generator.
• a characteristic encoding of the add-on device can be provided, e.g. by generating characteristic sounds featuring respective acoustic or haptic signals of varying duration and/or magnitude.
• the electronic signal generator may activate anonymously, e.g. when the add-on device is transferred from a sleep mode into an activated mode. This way and every time a user intends to use the injection device equipped with the add-on device the respective user-perceptible device identification will be generated or refreshed and provided to the user.
• the electronic signal generator may automatically switch off or may be transferred into a sleep mode, e.g. after lapse of a predefined time interval the add-on device has been used the last time.
• the add-on device comprises an electronic display coupled to the processor and operable to illustrate the device identification.
• the electronic display may comprise a display section that can be reconfigured in order to provide or to act as a user- perceivable device identification.
• the user-perceptible device identification may be provided by the electronic display of the device.
• a background color of the electronic display may be representative of the machine-readable identification of the injection device.
• a particular or characteristic display section may represent the user- perceptible device identification.
• the information as usually provided on or by the electronic display may be reproduced in this particular color-code or an information content as provided on the electronic display may be framed by the characteristic color-code of the injection device or medicament as encoded by the machine-readable identification thereof.
• the electronic display comprises an electrophoretic display exhibiting a particularly low electric power consumption, in particular when the add-on device is not in use.
• Such an electronic display may persistently or durably represent or provide the user-perceptible device identification, e.g. in form of a specific color and/or in form of a characteristic pattern or illustration on the electronic display.
• the device identification is persistently and/or durably perceivable from outside the add-on device.
• the device identification and/or the respective identifier may remain persistently and durably on the add-on device until it is reconfigured by the processor of the electronic module, e.g. in the course of detaching and re-attaching the add-on device to another injection device.
• the electronic module in particular its processor may be configured to configure or to reconfigure the device identification when detecting a machine-readable identification of the injection device, e.g. in the course of assembling or attaching the add-on device to the injection device.
• the device identification is arranged on or is integrated into the device body.
• the device identification may comprise a window located in a sidewall of the device body.
• the window may cover an electronic signal generator operable to generate at least a visual device identification and/or a visual identifier.
• the user perceptible device identification may comprise a kind of a light guide optically coupled with the light source or with numerous light sources of the electronic signal generator.
• a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases.
• API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.
• the drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device.
• the drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs.
• the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days).
• the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C).
• the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber.
• the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body.
• the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing.
• the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.
• the drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders.
• APIs for the treatment and/or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof.
• an insulin e.g., human insulin, or a human insulin analogue or derivative
• GLP-1 glucagon-like peptide
• DPP4 dipeptidyl peptidase-4
• the term ..derivative refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids.
• one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.
• insulin analogues examples include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
• an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.
• mipomersen sodium Korean, a benzyl alcohol, a benzyl ether, a benzyl ether, a benzyl ether, a benzyl-containing asen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.
• DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.
• hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.
• Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
• Somatropine Somatropin
• Desmopressin Terlipressin
• Gonadorelin Triptorelin
• Leuprorelin Buserelin
• Nafarelin Nafarelin
• Goserelin Goserelin.
• the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region.
• the term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).
• TBTI tetravalent bispecific tandem immunoglobulins
• CODV cross-over binding region orientation
• fragment refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and/or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen.
• Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments.
• Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies.
• SMIP small modular immunopharmaceuticals
• Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device.
• Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
• An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems.
• the container may be a replaceable container or an integrated non-replaceable container.
• a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
• Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
• Fig. 4 shows three further configurations of another example of an add-on device attached to the proximal end of an injection device
• Fig. 9 shows a mutual pairing between the add-on device and the external electronic device
• Fig. 10 illustrates a readout of the machine-readable identification of the injection device in the course of assembling the add-on device to the injection device
• Fig. 11 shows a configuration of the external electronic device after a successful mutual pairing between the add-on device, the injection device and the external electronic device
• Fig. 14 shows a block diagram of the add-on device, the injection device and the external electronic device and
• the injection device 1 comprises a housing 10.
• the housing 10 may comprise numerous housing components, such as a body 6 and a cartridge holder 7.
• the body 6 may be sized and configured to accommodate a drive mechanism 20.
• the cartridge holder 7 is sized and configured to accommodate a medicament container 21, e.g. implemented as a cartridge containing the liquid medicament 24.
• the medicament container 21 comprises a tubular-shaped barrel 22 sealed towards the distal end by a seal 23.
• the seal 23 may comprise a pierceable septum fixed to an outlet 25 of the medicament container 21.
• Towards a proximal end the interior of the barrel 22 is sealed by a piston 18 or stopper, which is slidably disposed inside the barrel 22.
• the cartridge holder 7 and hence a portion of the housing 10 is to be received in a protective cap 16, which is detachably connectable to the cartridge holder 7 or body 6.
• the fastening ribs 64 provide a friction fit with the dose dial 8 when the device body 60 is assembled to the dose dial 8 of the injection device 1.
• the receptacle 63 may be confined in longitudinal direction by a flange portion 62 protruding radially inwardly from the tubular-shaped sidewall 61 of the receptacle 63.
• the flange portion 62 is located proximally offset from the insert opening of the receptacle 63.
• the flange portion 62 may be of annular shape and may be configured to axially abut on a stepped down section at the proximal end of the dose dial 8.
• the user For dispensing of a dose the user has to depress the movable part 70, which may then be subject to a distally directed motion relative to the device body 60.
• the movable part 70 which may be in direct or indirect mechanical engagement with the trigger 9, may then apply a respective dispensing force onto the trigger 9 thereby initiating a dose dispensing action of the injection device 1.
• the add-on device 30 as schematically illustrated in Fig. 14 comprises an electronic module 34.
• the electronic module 34 comprises a printed circuit board 36.
• the electronic module 34 comprises a processor 44, an electronic memory 40 and a clock 42.
• the electronic module 34 comprises a power source 46 and the sensor 48.
• the electronic module 34 also comprises a signal generator 52 coupled to the processor 44 and/or coupled to the power source 46.
• the electronic module 34 further comprises at least one of a reader 37 and a wireless transceiver 38, 39.
• the add-on device 30 also comprises a user perceptible device identification 50.
• the device identification 50 comprises or includes the signal generator 52 coupled to the processor 44 and operable or reconfigurable by the processor 44.
• the device identification 50 comprises an electronic display 51 operable to visibly illustrate various identifiers 55 being indicative of the injection device 1 to which the add-on device 30 is connected or coupled to.
• the signal generator 52 is operable to generate at least one of a visual, an acoustic and a haptic device identification and hence produce or to generate a visual identifier, an acoustic identifier or a haptic identifier.
• the signal generator 52 may comprise a speaker operable to generate an acoustic signal, wherein the acoustic signal represents or constitutes an identifier, e.g. in form of an acoustic code or sequence being indicative of the injection device 1 or of the medicament 24 located inside a medicament container 21 of the injection device 1.
• the electronic signal generator 52 is coupled to the processor 44 of the add-on device 30 and in particular of the electronic module 34 of the add-on device 30.
• the processor 44 is configured to generate different acoustic signals in cooperation with the signal generator 52 implemented as a speaker.
• a first acoustic signal being indicative of a first injection device 1 or medicament 24 and at least a second acoustic signal being indicative of another injection device T or another medicament 24' can be generated.
• the first and second acoustic signals are audibly distinguishable by a user of the injection device 1.
• the movable part 70 forms or constitutes the reconfigurable and user-perceptible device identification 50.
• the add-on device 30 is configured to read a machine- readable identification 28 of the injection device 1.
• the machine-readable identification 28 may be implemented as an electronic identifier 29 as illustrated in Fig. 14 and may be configured to communicate with a suitable reader 37, e.g. with a short range transceiver 38 of the add-on device 30.
• the transceiver 38 being operable to read-out the machine-readable identification 28 of the injection device 1.
• the reader 37 or transceiver 38 is operably connected to the processor 44 and is hence operable to transfer the data obtained from the machine-readable identification 28 to the processor 44.
• the processor 44 is in turn operable to process the machine-readable information as obtained from the machine-readable identification 28 and is further operable to configure or to reconfigure the user perceptible device identification 50.
• the user perceptible device identification 50 comprises a signal generator 52, e.g. implemented as a light source operable to illuminate the movable part 70.
• the movable part 70 may comprise at least one of a window or a transparent portion through which an optical signal as generated by a light source of the electronic signal generator 52 becomes visible.
• the entirety of the movable part protruding from the device body 60 may be of a transparent or semitransparent material. It may comprise a frosted or translucent plastic material, e.g. providing an optical diffusion when illuminated by a light source. This way, the movable part may be homogenously illuminated.
• the processor 44 is operable to conduct a reconfiguration of the user-perceptible device identification 50, which may then produce or generate a first identifier 55 that is visible at or through the movable part 70.
• the movable part 70 may be illuminated in a first color thus forming or constituting the first identifier 55.
• the device identification 50 When attaching the add-on device 30" to a further add-on device 1" and upon read-out of a respective machine-readable a modification 28" the device identification 50 produces or generates a third identifier 55".
• the window 56 appears in a third color that distinguishes from the colors of the identifiers 55, 55'.
• the machine-readable identification 28, e.g. implemented as an electronic identifier readable by the reader 37 or by the short range transceiver 38 of the add-on device 30 may simply contain a code representing a color of the label 17.
• the injection system 120 comprises the injection device 1 and the add-on device 30.
• the display 51 is separated into first display section 53 surrounded by a second display section 54.
• the first display section 53 is configured to visually illustrate various device parameters of the injection device 1 and/or of the add-on device 30.
• the surrounding second display section 54 is operable to generate or to reproduce the variable identifier 55, 55'.
• the second display section 54 With the add-on device 30" and in a first configuration the second display section 54 is configured to generate a first identifier 55.
• the second display section 54 may be provided in a first color.
• the identifier 55' changes.
• the display section 54' is e.g. illuminated in a color that distinguishes from the color of the display section 54 of the addon device 30".
• the machine-readable identification 28 comprises an electronic identifier 29, such as a NFC tag that is readable by the short range transceiver 38 of the add-on device 30.
• the machine-readable identification 28 Upon readout of the machine-readable identification 28, which may be located inside or on an outside of the injection device 1 characteristic information being indicative of the type of the injection device 1 and/or of the type of the medicament 24 to be dispensed by the injection device 1 can be provided and transferred to the add-on device 30.
• the processor 44 of the add-on device 30 is operable to configure or to reconfigure the user perceptible device identification 50.
• the pairing of the add-on device 30 with the injection device 1 as well as the readout of the machine-readable identification 28 conducted by the add-on device 30 may be also transmitted to the external electronic device 100, which in turn may indicate to a user that the add-on device 30 has been suitably paired and/or mechanically connected to the injection device 1.
• the device identification 55 is integrated into the movable part 70 of the add-on device 30 and is operable to provide a visible identifier 55 in form of illuminating the movable part 70 in a characteristic color or by producing a characteristic temporal illumination sequence.
• a further configuration of the injection system 120 is illustrated.
• the movable part 70 may still be illuminated in a characteristic color.
• the notification 154 of the external electronic device 100 has changed to a notification 154'.
• the external electronic device 100 informs the user to conduct an injection procedure right now.
• the external electronic device 100 also provides information about the dosing of the medication.
• the communication link between the external electronic device 100 and the add-on device 30 may be further used to indicate to a user that an injection procedure is due, e.g. by a simple modification of the identifier 55'.
• the identifier 55' may comprise a flashlight or a blinking light.
• the external electronic device 100 may invoke generation of an acoustic signal or of a haptic signal as an identifier 55 on or by the add-on device 30.
• a flowchart of a method of configuring the add-on device 30 In a first step 200 an injection device 1 as described above is provided.
• the injection device 1 comprises a machine-readable identification 28 being indicative of the type of the injection device 1 and/or of a type of the medicament 24 located inside the injection device 1 or intended to be injected with the injection device 1.

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• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

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• 2023
  • 2023-08-28 JP JP2025512601A patent/JP2025529941A/ja active Pending
  • 2023-08-28 CN CN202380060746.9A patent/CN119947768A/zh active Pending
  • 2023-08-28 EP EP23761534.9A patent/EP4580701A1/de active Pending
  • 2023-08-28 WO PCT/EP2023/073460 patent/WO2024046932A1/en not_active Ceased

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