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WO2025157565A1 - Sous-ensemble d'un dispositif d'administration de médicament - Google Patents

Sous-ensemble d'un dispositif d'administration de médicament

Info

Publication number
WO2025157565A1
WO2025157565A1 PCT/EP2024/088431 EP2024088431W WO2025157565A1 WO 2025157565 A1 WO2025157565 A1 WO 2025157565A1 EP 2024088431 W EP2024088431 W EP 2024088431W WO 2025157565 A1 WO2025157565 A1 WO 2025157565A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
medicament
rotator
sub
cap
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
PCT/EP2024/088431
Other languages
English (en)
Inventor
Daniel Carlsson
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 WO2025157565A1 publication Critical patent/WO2025157565A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2422—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M2039/167—Tube connectors; Tube couplings having provision for disinfection or sterilisation with energizing means, e.g. light, vibration, electricity
    • 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
    • A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
    • A61M2205/051—General characteristics of the apparatus combined with other kinds of therapy with radiation therapy
    • A61M2205/053—General characteristics of the apparatus combined with other kinds of therapy with radiation therapy ultraviolet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers

Definitions

  • a sub-assembly of a medicament delivery device A sub-assembly of a medicament delivery device.
  • the present disclosure generally relates to a sub-assembly of a medicament delivery device, and particularly to a sub-assembly of a medicament delivery device comprising an information tag and a tag reader.
  • Medicament delivery devices such as auto-injectors, inhalers, or on-body devices are generally known for the self-administration of a medicament by patients without formal medical training.
  • patients suffering from diabetes or people who are undergoing an artificial fertilization procedure may require repeated injections of insulin or hormones.
  • Other patients may require regular injections of other types of medicaments, such as a growth hormone.
  • those medicament delivery devices are designed for patients without formal medical training operation of those medicament delivery devices might be taking place in a patient's own house, which is usually not in a place of professional health/ medical care, e.g. hospital, clinic or health centres, there is a demand for automatically recording every single delivery operation that has been taken by the user.
  • the record can help the user to track his/ her medicament intake or as the basis of an alarm as the next operation reminder; the record can also help a medical doctor or a health care provider to track the compliance of the user regarding the therapeutic regimen.
  • Furthermore, to ensure users' safety in accessing/ using a medicament delivery device there is also a demand for stopping users from accessing or using a medicament delivery device which has been used.
  • Electronic medicament delivery devices have been developed for allowing patients to safely administer medicament, without the need for help from health professionals, and to allow transmission of data to the health professionals.
  • Data is generally transmitted by an electronic component that is powered by a battery integrated within the device or through a wired connection by an external power source.
  • the material cost of electronics that can provide the above-mentioned functions is reducing.
  • the cost of manufacture is increasing, by either the increasing cost of manpower or the increasing cost of making a more complicated automatic assembling machine, so there is still room for simplifying the assembling process for medicament delivery devices.
  • 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 members 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 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.
  • 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 relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component.
  • radial refers to a direction extending radially relative to the axis
  • rotation refers to rotation relative to the axis.
  • a sub-assembly of a medicament delivery device comprising: a housing extending along a longitudinal axis between a proximal end and a distal end; wherein the housing is configured to accommodate a medicament container containing medicament; a rotator having a body arranged within the housing; wherein the body of the rotator is configured to be rotated around the longitudinal axis; wherein the body of the rotator is configured to be operably connected to the medicament container such that a predetermined amount of contained medicament is expelled or selected in response to the rotation of the rotator; wherein the rotator comprises an information tag fixedly attached to the body of the rotator; a cap removably attached to the housing; wherein the cap comprises a tubular body at least partially enclosing the housing when the cap is attached to the housing; wherein the cap comprises a processor and a tag reader electrically connected to the processor; wherein the tag reader is configured to read information contained in the information tag;
  • the rotator is a rotational drive.
  • the body of the rotator is configured to be operably connected to the medicament container such that a predetermined amount of contained medicament is expelled in response to a proximal movement of the rotator in the direction of the longitudinal axis relative to the housing.
  • the rotational drive is a rotatable plunger rod configured to be in contact with the medicament container such that when the plunger rod is moved in the proximal direction relative to the housing by being rotated relative to the housing the predetermined amount of contained medicament is expelled.
  • the rotational drive is a rotatable driver configured to move a plunger rod in the proximal direction relative to the housing to expel the predetermined amount of contained medicament.
  • the rotatable driver comprises a driver body threadedly engaged with the plunger rod.
  • the rotatable driver is configured to be rotated by the user to select the predetermined amount of contained medicament.
  • the rotatable driver is configured to be moved in the proximal direction relative to the housing such that the plunger rod is proximally moved by the rotatable driver to expel the selected amount of the contained medicament.
  • the rotatable driver is configured to be manually moved in the proximal direction relative to the housing by the user.
  • the sub-assembly comprises an energy source accommodated within the housing; wherein the rotatable driver is configured to be moved in the proximal direction relative to the housing by the energy source.
  • the sub-assembly comprises a user dial movably attached to the housing.
  • the user dial is operably connected to the rotatable driver such that the rotatable driver is rotated by the user dial when the user dial is manually rotated around the longitudinal axis relative to the housing.
  • the housing comprises a powerpack housing extending along the longitudinal axis between the distal end of the housing and a proximal end of the powerpack housing.
  • the rotator is accommodated in the powerpack housing.
  • the housing comprises a container housing extending along the longitudinal axis between a distal end of the container housing and the proximal end of the housing.
  • the medicament container is accommodated in the container housing.
  • the powerpack housing is attached to the container housing.
  • the tag reader comprises two receiving units configured to read the information contained in the information tag.
  • the two receiving units are positioned opposite to one another in a direction transverse to the longitudinal axis.
  • the two receiving units are two RFID/NFC antennas.
  • the rotator is movable relative to the housing in the direction of the longitudinal axis between an initial position and a used position being proximally located to the initial position relative to the housing.
  • the information tag of the rotator is spaced apart from the tag reader when the rotator is positioned in the initial position and is lined up with the tag reader when the rotator is in the used position.
  • the cap comprises a switch configured to switch the processor to an active state from an inactive state when the cap is attached to the housing.
  • the switch is operably connected to the housing when the cap is attached to the housing such that the process is maintained in the active state when the cap is attached to the housing and is in the inactive state when the cap is removed from the housing.
  • the processor is configured to reset when the processor is in the active state and the information tag is spaced apart from the tag reader.
  • the processor is configured to receive the information related to the medicament delivery device from the information tag.
  • the tubular body of the cap comprises a proximal wall extending in the direction transverse to the longitudinal axis.
  • the proximal wall of the tubular body of the cap is configured to seal the proximal end of the housing.
  • the cap comprises an Ultraviolet (UV) emitting diode positioned on the proximal wall facing towards the proximal end of the housing such that the Ultraviolet (UV) emitting diode can emit Ultraviolet to the proximal end of the housing.
  • UV Ultraviolet
  • the tubular body of the cap comprises an Ultraviolet shield extending around the longitudinal axis.
  • the Ultraviolet shield is configured to shield the medicament container from Ultraviolet.
  • the container housing is enclosed by the Ultraviolet shield when the cap is attached to the housing.
  • the sub-assembly is used in a medicament delivery device.
  • the medicament delivery device comprises a medicament container containing medicament, and a medicament delivery member operably connected to the medicament container for delivering the contained medicament.
  • the medicament delivery member of the medicament delivery device is a needle or a spray nozzle.
  • the medicament container of the medicament delivery device is a syringe, a cartridge or a collapsible bag.
  • the medicament container of the medicament delivery device is made of glass material or plastic material.
  • the medicament delivery device is an injection device, an inhalation device, or a medical sprayer.
  • the medicament delivery device is an auto- injector.
  • the medicament delivery device is a hand-held, pen-type auto- injector.
  • 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, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies 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-1a multiple sclerosis
  • sumatriptan miraines
  • adalimumab rheumatoid arthritis
  • darbepoetin alfa anaemia
  • belimumab laupus
  • peginterferon beta-1 a' multiple sclerosis
  • sarilumab rheumatoid arthritis
  • semaglutide type 2 diabetes, obesity
  • dupilumab atopic dermatitis, asthma, nasal polyps, allergies
  • glucagon glucagon
  • ipilimumab nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab,
  • 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.
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or biooncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • an immuno-oncology or biooncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD- 1/PD-L1 inhibitors/modulators, B-lymphocyte antigen CD19 inhibitors, B-lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21 , Mini-CHOP, Maxi- CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, D
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those used for chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • chemotherapy such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.
  • Fig. 1 schematically shows a perspective view of a medicament delivery device comprising a sub-assembly of the invention
  • Fig. 2 schematically shows a perspective view of the sub-assembly of Fig. 1 comprising a housing and a cap;
  • Fig. 3 schematically shows a perspective view of elements of the medicament delivery device of Fig 1;
  • Fig. 4 schematically shows a perspective view of the cap of the sub-assembly of Fig. 2;
  • Figs 5A-5C schematically show perspective views of the sub-assembly in the first, second and third dose detection scenarios.
  • Figs 1-5C illustrate a sub-assembly of a medicament delivery device.
  • the medicament delivery device is a multi-use medicament delivery device.
  • the medicament delivery device is designed to be used by a user to deliver medicament more than one time.
  • the medicament delivery device can be a reusable medicament delivery device.
  • the user can exchange the medicament container after each medicament delivery operation; or the user can exchange the medicament container when predetermined doses of medicament from one medicament container have been delivered.
  • the medicament delivery device can be a disposable medicament delivery device.
  • the user can dispose of the entire medicament delivery device after a predetermined dose of medicament in the medicament delivery device has been delivered, e.g., the medicament delivery device is designed to be used for 3 times to deliver 3 identical predetermined doses each time, the user can dispose the medicament delivery device after 3 times of use.
  • the user is required to attach a medicament delivery member before each medicament delivery.
  • the user needs to attach a new pen needle before each injection when the medicament delivery device is a multi-use injector.
  • the sub-assembly comprises a housing 1 extending along a longitudinal axis L between a proximal end and a distal end.
  • the housing 1 is configured to accommodate a medicament container M containing medicament.
  • the medicament container is configured to be fluidly connected to a medicament delivery member to deliver the contained medicament to a medicament delivery site.
  • the medicament container is a syringe
  • the delivery member is a needle.
  • the needle is integral at a proximal end of the syringe.
  • the medicament container can be a cartridge, and the medicament delivery member is a needle that is preassembled or attachable (by a user of the medicament delivery device) to the medicament delivery device and is configured to fluidly communicate with the cartridge during use.
  • the medicament container is a collapsible bag connectable to a medicament delivery member, e.g., a needle and/or a tube and/or a soft cannula.
  • the medicament container is made of plastic.
  • the housing as shown in Fig. 5, the housing
  • I comprises a powerpack housing 10 extending along the longitudinal axis L between the distal end of the housing 1 and a proximal end of the powerpack housing 10.
  • a rotator 3 (which will be explained in detail later) is accommodated in the powerpack housing 10.
  • the housing 1 comprises container housing 11 extending along the longitudinal axis L between a distal end of the container housing
  • the medicament container M is accommodated in the container housing 11.
  • the powerpack housing 10 is attached to the container housing 11.
  • the distal end of the container housing 11 is attached to the proximal end of the powerpack housing 10.
  • the powerpack housing is releasably attached to the container housing, e.g., via a thread connection or a bayonet connection.
  • the powerpack housing and the container housing can be integrated as one piece; or connected via a snap-fit that cannot be released by the user.
  • the proximal end of the container housing 11 comprises a medicament delivery member attachment 13, e.g., a thread structure, as shown in Fig. 2.
  • the sub-assembly further comprises the rotator 3 having a body arranged within the housing 1.
  • the body of the rotator 3 is configured to be rotated around the longitudinal axis L.
  • the body of the rotator 3 is configured to be operably connected to the medicament container such that a predetermined amount of contained medicament is expelled or selected in response to the rotation of the rotator 3.
  • the rotator 3 comprises an information tag 9 fixedly attached to the body of the rotator 3.
  • the sub-assembly further comprises a cap 2 removably attached to the housing 1.
  • the cap 2 comprises a tubular body 20 at least partially enclosing the housing 1 when the cap 2 is attached to the housing 1.
  • the cap 2 comprises a processor 22 and a tag reader 23a, 23b electrically connected to the processor 22.
  • the tag reader 23a, 23b is configured to read information contained in the information tag 9.
  • the processor 22 is spaced apart from the tag reader 23a, 23b and is connected to the tag reader 23a, 23b via a wire 24, as shown in Fig. 4.
  • the processor 22 is configured to identify the expelled or selected amount of contained medicament by detecting a position of the information tag 9 via the tag reader 23a, 23b.
  • the position of the information tag 9 reflects the expelled or selected dose.
  • the processor can detect the position of the information tag 9 based on whether the tag reader 23a, 23b can read the information tag and/or receive a signal from the information tag with a predetermined signal strength and/or how many time that the information tag has been read.
  • the information tag can be barcodes, quickresponse codes (QR codes), and/or an RFID/NFC tag.
  • the sub-assembly can be used in a manual medicament delivery device or an automatic medicament delivery device.
  • the term ‘manual medicament delivery device ‘used herein refers to a medicament delivery device that the user needs to manually force the medicament to be expelled. Such as an insulin pen.
  • the term ‘automatic medicament delivery device ‘used herein refers to a medicament delivery device that comprises an energy source to force the medicament to be expelled. Such as an autoinjector, e.g., SurePalTM.
  • the energy source can be a spring, e.g., a compression spring, a torsion spring, a gas canister, or a motor.
  • Both the manual medicament delivery device and the automatic medicament delivery device may comprise a rotatable dose drum and/or a rotatable plunger rod and/or a rotatable driver to move a plunger rod in the proximal direction relative to the housing.
  • the rotatable dose drum is configured to rotate by the user to select a dose to be delivered; and the rotatable plunger rod is configured to be in contact with the medicament container, thus, when the plunger rod is moved in the proximal direction relative to the medicament container with a rotation that is caused by either the energy source or user’s hand force, a predetermined dose can be expelled.
  • the rotatable driver usually is a conjunction between the plunger rod and the dose drum.
  • the rotatable driver usually participates in both the amount of medicament selection operation and the selected medicament delivery operation.
  • the dose drum can be used to move the rotatable driver to a certain position and when the medicament delivery operation is triggered, the rotatable driver can be used to move the plunger rod in the proximal direction relative to the housing with a certain distant that is determined by the moved position of the rotatable driver by the dose drum.
  • the rotator is a rotational drive.
  • the body of the rotator is configured to be operably connected to the medicament container such that a predetermined amount of contained medicament is expelled in response to a proximal movement of the rotator in the direction of the longitudinal axis relative to the housing.
  • the rotator can be a dose drum configured to be used to set a dose to be delivered by the user.
  • the body of the rotator is configured to be operably connected to the medicament container such that a predetermined amount of contained medicament is selected in response to the rotation of the rotator.
  • the rotational drive can be the rotatable plunger rod of the medicament delivery device.
  • the rotatable plunger rod is in contact with a rubber stopper when the medicament container is a cartridge or a syringe and by urging the rubber stopper in the proximal direction relative to the medicament container, an amount of the contained medicament is expelled.
  • the rotational drive is a rotatable driver configured to move a plunger rod configured to be in contact with the medicament container such that the plunger rod is moved in the proximal direction relative to the housing by the rotatable driver to expel the predetermined amount of contained medicament.
  • the plunger rod is moved in the proximal direction relative to the housing by the rotation of the rotatable driver.
  • the plunger rod is moved in the proximal direction relative to the housing by the linear movement of the of the rotatable driver; in this example, the rotation of the rotatable driver is configured to select an amount of the contained medicament to be expelled.
  • the rotational drive is a rotatable driver 3 comprises a driver body threadedly engaged with the plunger rod 4.
  • the rotatable driver 3 is configured to be rotated by the user to select the predetermined amount of contained medicament.
  • the rotatable driver 3 is configured to be moved in the proximal direction relative to the housing 1 such that the plunger rod 4 is proximally moved by the rotatable driver to expel the selected amount of the contained medicament.
  • the rotatable driver is configured to be manually moved in the proximal direction relative to the housing by the user.
  • the sub-assembly comprises an energy source 6 accommodated within the housing 1.
  • the rotatable driver 3 is configured to be moved in the proximal direction relative to the housing 1 by the energy source 6.
  • the rotatable driver 3 is connected to a user dial 8.
  • the rotatable driver 3 is rotated by the user.
  • the rotatable driver 3 can be moved in the distal direction relative to the housing 1 by the rotation via the thread engagement between the rotatable driver 3 and the plunger rod 4.
  • the housing 1 may comprises a cam sleeve 12 having a helical cam engaged with a protrusion of the rotatable driver 3.
  • the rotatable driver 3 can be moved in the distal direction relative to the housing 1 via the engagement between the cam sleeve and the rotatable driver 3.
  • the energy source 6 is a spring positioned between a ledge of the housing 1 and the rotatable driver 3.
  • the rotatable driver 3 comprises a flexible arm having a proximally directed surface and the housing 1 comprises a retaining ledge configured to engage the proximally directed surface of the flexible arm.
  • the sub-assembly comprises a push button 7.
  • a wall of the button is configured to bend the flexible arm of the rotatable driver 3 such that the rotatable driver 3 is disengaged from the retaining ledge of the housing 1.
  • the spring 6 moves the rotatable driver 3 linearly along with the plunger rod 4 in the proximal direction relative to the housing 1.
  • the contained medicament is expelled.
  • the amount of medicament to be expelled is selected by the distal movement of the rotatable driver 3 and expelled by the proximal movement of the rotatable driver 3.
  • every medicament delivery operation of the medicament delivery device is configured to deliver the same amount of the contained medicament to the user, in this example, the distal movement of the rotatable driver 3 is used to select one single amount of the medicament.
  • the rotatable driver 3 distal movement of the rotatable driver 3 is achieved by the rotation of the rotatable driver 3 and the helical engagement between the protrusion of the rotatable driver 3 and the helical cam of the cam sleeve 12.
  • the rotator 3 is movable relative to the housing 1 in the direction of the longitudinal axis L between an initial position and a used position being proximally located to the initial position relative to the housing 1.
  • the information tag 9 of the rotator 3 is spaced apart from the tag reader 23a, 23b when the rotator 3 is positioned in the initial position and is lined up with the tag reader 23a, 23b when the rotator 3 is in the used position.
  • the information contained in the information tag 9 can only be read by the tag reader 23a, 23b when the rotator 3 is in the used position (when the information tag 9 is a barcode or QR code, for example).
  • the tag reader 23a, 23b only receives a relatively weak signal from the information tag 9 when the information tag 9 is spaced apart from the tag reader 23a, 23b (when the information tag 9 is an RFID/NFC, for example).
  • the sub-assembly is suitable to be reusable.
  • the user exchanges the medicament container after a predetermined doses are delivered and resets the device, e.g., moves the plunger rod and/or the rotational drive that is configured to rotate the plunger rod back to the initial position.
  • the rotator is the rotational drive.
  • the processor 22 can be used to calculate the how many doses that the user has already taken from one medicament container and reset, e.g., erase the record or start a new record of dose, when no information/information from a weak signal is read from the information tag 9 and the cap 2 is attached to the housing 1.
  • the processor 22 can be used to calculate the dose by comparing an identified expelled or selected amount of contained medicament with a recorded previously identified expelled or selected amount of contained medicament.
  • the residual doses of contained medicament can be detected; and/or the delivered dose accuracy can be detected.
  • the tag reader 23a, 23b comprise two receiving units 23a, 23b configured to read the information contained in the information tag.
  • the two receiving units 23a, 23b are positioned opposite to one another in a direction transverse to the longitudinal axis L, as shown in Figs 4-5C.
  • only one of the two receiving units 23a, 23b of the tag reader 23a, 23b can read the information tag 9 when the information tag 9 is lined up with one of the two receiving units 23a, 23b.
  • two receiving units 23a, 23b receive signals with different strengths from the information tag 9.
  • the tag reader can judge the position of the information tag by the signal strength from these two receiving units 23a, 23b; thus, the detection of the position of the information tag 9 can be more precise.
  • the processor can calculate the number of doses based on the detection from the two receiving units 23a, 23b. For example, Fig. 5A shows a first dose is delivered when the information tag 9 is lined up with one of the two receiving units 23a, 23b. Fig. 5B shows a second dose is delivered when the information tag 9 is lined up with the other one of the two receiving units 23a, 23b.
  • Fig. 5A shows a first dose is delivered when the information tag 9 is lined up with one of the two receiving units 23a, 23b.
  • Fig. 5B shows a second dose is delivered when the information tag 9 is lined up with the other one of the two receiving units 23a, 23b.
  • 5C shows a third dose is delivered when the information tag 9 is lined up again with one of the two receiving units 23a, 23b that has been lined up with the information tag 9 previously.
  • the processor can calculate the amount of used medicament, e.g., by detecting the position of the information tag 9 in the direction of the longitudinal axis L and/or by calculating how many doses have been delivered together with the predetermined data of the amount of each dose.
  • the cap 2 comprises a switch 25 configured to switch the processor 22 to an active state from an inactive state when the cap 2 is attached to the housing 1.
  • the switch 25 is operably connected to the housing 1 when the cap 2 is attached to the housing 1 such that the process 22 is maintained in the active state when the cap 2 is attached to the housing 1 and is in the inactive state when the cap 2 is removed from the housing 1.
  • the switch can be a mechanical contact switch configured to be moved by a part of the housing when the cap is attached to the housing.
  • the switch can be a non-contact switch, e.g., a reed switch.
  • the processor 22 is configured to receive the information related to the medicament delivery device from the information tag 9. Such as the name of the medicament, the prescribed dose, the manufacture information... etc.
  • the tubular body 20 of the cap 2 comprises a proximal wall 21 extending in the direction transverse to the longitudinal axis L.
  • the proximal wall 21 of the tubular body 20 of the cap is configured to seal the proximal end of the housing 1.
  • the cap comprises an Ultraviolet (UV) emitting diode 26 positioned on the proximal wall facing towards the proximal end of the housing such that the Ultraviolet (UV) emitting diode 26 can emit Ultraviolet to the proximal end of the housing.
  • UV Ultraviolet
  • the UV emitting diode 26 is configured to emit UV to the proximal end of the medicament container as most of the medicament containers have an opening configured to be connected with a medicament delivery member at the proximal end; as a result, the UV emitting diode 26 is configured to disinfect and/or suppress any potential bacteria ingress to the medicament container.
  • the tubular body 20 of the cap 2 comprises an Ultraviolet shield extending in around the longitudinal axis L.
  • the Ultraviolet shield is configured to shield the medicament container from Ultraviolet.
  • the medicament container comprises a transparent body
  • the Ultraviolet shield is configured to prevent the medicament contained within the medicament container from exposing to the environment Ultraviolet.
  • the housing 1 comprises the powerpack housing 10 and the container housing 11
  • the container housing 10 is enclosed by the Ultraviolet shield when the cap 2 is attached to the housing 1.
  • the cap may comprise an electronic set comprising the processor 22.
  • the electronic set comprises a communication unit.
  • the communication unit can be a short-range communication unit, such as RFID, NFC, infra-red, ZigBee, Bluetooth, Bluetooth beacon, and/or a long-range communication unit, such as 3G, 4G, CAT-M1 , NB-loT, LoRa, Sigfox, 5G, or GPRS.
  • the electronic set comprises a memory, and/or a clock, and/or an indicator and/ or a sensor.
  • the memory can be a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM) or a Flash memory, such as a compact Flash memory.
  • the indicator can be an acoustic indicator, such as a speaker or a buzzer.
  • the indicator can be a visual indicator, such as an e-ink display, an LCD or a LED light emitter and/or the indicator can be a haptic indicator, such as a vibrator.
  • the senor can be an orientation sensor, such as an accelerometer or a gyroscope, and/or the sensor can be an environmental condition sensor, such as a temperature sensor, vibration sensor or contact sensor.
  • the electronic set comprises a battery, e.g., a coin-sized battery or a thin film battery and/or a energy harvesting unit, e.g., a piezoelectric unit.
  • the housing may be provided with (i.e. , molded in, molded with) a compound featuring persistently antimicrobial, antifungal, and/or antiviral properties.
  • a compound featuring persistently antimicrobial, antifungal, and/or antiviral properties may be applied to the molded (i.e., finished) components through secondary processes (e.g., chemical vapor deposition), spraying, or dipping processes.
  • a sub-assembly of a medicament delivery device comprising: a housing extending along a longitudinal axis between a proximal end and a distal end; wherein the housing is configured to accommodate a medicament container containing medicament; a rotator having a body arranged within the housing; wherein the body of the rotator is configured to be rotated around the longitudinal axis; wherein the body of the rotator is configured to be operably connected to the medicament container such that a predetermined amount of contained medicament is expelled or selected in response to the rotation of the rotator; wherein the rotator comprises an information tag fixedly attached to the body of the rotator; a cap removably attached to the housing; wherein the cap comprises a tubular body at least partially enclosing the housing when the cap is attached to the housing; wherein the cap comprises a processor and a tag reader electrically connected to the processor; wherein the tag reader is configured to read the information contained in the information tag; and where
  • the rotator is a rotational drive; wherein the body of the rotator is configured to be operably connected to the medicament container such that a predetermined amount of contained medicament is expelled in response to a proximal movement of the rotator in the direction of the longitudinal axis relative to the housing.
  • the rotational drive is a rotatable plunger rod configured to be in contact with the medicament container such that when the plunger rod is moved in the proximal direction relative to the housing by being rotated relative to the housing the predetermined amount of contained medicament is expelled.
  • the rotational drive is a rotatable driver configured to move a plunger rod in the proximal direction relative to the housing to expel the predetermined amount of contained medicament.
  • the rotatable driver comprises a driver body threadedly engaged with the plunger rod; wherein the rotatable driver is configured to be rotated by the user to select the predetermined amount of contained medicament; and wherein the rotatable driver is configured to be moved in the proximal direction relative to the housing such that the plunger rod is proximally moved by the rotatable driver to expel the selected amount of the contained medicament.
  • subassembly according to any one of clauses 2-7, wherein the subassembly comprises a user dial movably attached to the housing; wherein the user dial is operably connected to the rotatable driver such that the rotatable driver is rotated by the user dial when the user dial is manually rotated around the longitudinal axis relative to the housing.
  • the housing comprises a powerpack housing extending along the longitudinal axis between the distal end of the housing and a proximal end of the powerpack housing; wherein the rotator is accommodated in the powerpack housing; wherein the housing comprises a container housing extending along the longitudinal axis between a distal end of the container housing and the proximal end of the housing; wherein the medicament container is accommodated in the container housing; and wherein the powerpack housing is attached to the container housing.
  • the tag reader comprises two receiving units configured to read the information contained in the information tag; and wherein the two receiving units are positioned opposite to one another in a direction transverse to the longitudinal axis.
  • the rotator is movable relative to the housing in the direction of the longitudinal axis between an initial position and a used position being proximally located to the initial position relative to the housing; and wherein the information tag of the rotator is spaced apart from the tag reader when the rotator is positioned in the initial position and is lined up with the tag reader when the rotator is in the used position.
  • the cap comprises a switch configured to switch the processor to an active state from an inactive state when the cap is attached to the housing; and wherein the switch is operably connected to the housing when the cap is attached to the housing such that the process is maintained in the active state when the cap is attached to the housing and is in the inactive state when the cap is removed from the housing.
  • the processor is configured to receive the information related to the medicament delivery device from the information tag.
  • the tubular body of the cap comprises a proximal wall extending in the direction transverse to the longitudinal axis; wherein the proximal wall of the tubular body of the cap is configured to seal the proximal end of the housing; and wherein the cap comprises an Ultraviolet (UV) emitting diode positioned on the proximal wall facing towards the proximal end of the housing such that the Ultraviolet (UV) emitting diode can emit Ultraviolet to the proximal end of the housing.
  • UV Ultraviolet
  • the tubular body of the cap comprises an Ultraviolet shield extending around the longitudinal axis; and wherein the Ultraviolet shield is configured to shield the medicament container from Ultraviolet.

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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)

Abstract

La présente invention concerne un sous-ensemble d'un dispositif d'administration de médicament, le sous-ensemble comprenant : un boîtier s'étendant le long d'un axe longitudinal entre une extrémité proximale et une extrémité distale ; le boîtier étant conçu pour recevoir un récipient de médicament contenant un médicament ; un rotateur ayant un corps disposé à l'intérieur du boîtier ; le corps du rotateur étant conçu pour être entraîné en rotation autour de l'axe longitudinal ; le corps du rotateur étant conçu pour être relié de manière fonctionnelle au récipient de médicament de telle sorte qu'une quantité prédéterminée de médicament contenu soit expulsée ou sélectionnée à la suite de la rotation du rotateur ; le rotateur comprenant une étiquette d'informations fixée à demeure au corps du rotateur ; un capuchon fixé de manière amovible au boîtier ; le capuchon comprenant un corps tubulaire entourant au moins partiellement le boîtier lorsque le capuchon est fixé au boîtier ; le capuchon comprenant un processeur et un lecteur d'étiquette raccordé électriquement au processeur ; le lecteur d'étiquette étant conçu pour lire des informations présentes sur l'étiquette d'informations ; et le processeur étant conçu pour identifier la quantité expulsée ou sélectionnée de médicament contenu par détection d'une position de l'étiquette d'informations au moyen du lecteur d'étiquette.
PCT/EP2024/088431 2024-01-26 2024-12-24 Sous-ensemble d'un dispositif d'administration de médicament Pending WO2025157565A1 (fr)

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Application Number Priority Date Filing Date Title
EP24154197.8 2024-01-26
EP24154197 2024-01-26

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190321547A1 (en) * 2004-10-21 2019-10-24 Novo Nordisk A/S Injection Device with a Processor for Collecting Ejection Information
US20200261654A1 (en) * 2017-10-31 2020-08-20 Ypsomed Ag Monitoring of disposable injection devices
US10751481B2 (en) * 2015-07-23 2020-08-25 Shl Medical Ag Variable single dose injector
US20200368375A1 (en) * 2019-02-12 2020-11-26 Becton, Dickinson And Company Medical device to disinfect a skin surface
US20210252229A1 (en) * 2018-09-28 2021-08-19 Becton, Dickinson And Company Universal smart cap for pen injectors
US20220226583A1 (en) * 2019-06-13 2022-07-21 Sanofi Apparatus for Detecting a Dose of Medicament Delivered from an Injection Device

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190321547A1 (en) * 2004-10-21 2019-10-24 Novo Nordisk A/S Injection Device with a Processor for Collecting Ejection Information
US10751481B2 (en) * 2015-07-23 2020-08-25 Shl Medical Ag Variable single dose injector
US20200261654A1 (en) * 2017-10-31 2020-08-20 Ypsomed Ag Monitoring of disposable injection devices
US20210252229A1 (en) * 2018-09-28 2021-08-19 Becton, Dickinson And Company Universal smart cap for pen injectors
US20200368375A1 (en) * 2019-02-12 2020-11-26 Becton, Dickinson And Company Medical device to disinfect a skin surface
US20220226583A1 (en) * 2019-06-13 2022-07-21 Sanofi Apparatus for Detecting a Dose of Medicament Delivered from an Injection Device

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