A sub-assembly of a medicament delivery device.

Abstract

A sub-assembly of a medicament delivery device, the sub-assembly 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; and wherein the processor is configured to identify the expelled or selected amount of contained medicament by detecting a position of the information tag via the tag reader.

Description

[0001] TITLE

[0002] A sub-assembly of a medicament delivery device.

[0003] TECHNICAL FIELD

[0004] 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.

[0005] BACKGROUND

[0006] 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. For example, 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.

[0007] As 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.

[0008] 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. Nowadays, the material cost of electronics that can provide the above-mentioned functions is reducing. However, 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.

[0009] SUMMARY

[0010] The invention is defined by the appended claims, to which reference should now be made.

[0011] 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 members 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.

[0012] 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.

[0013] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0014] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer 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. Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis. There is hence provided a sub-assembly of a medicament delivery device, the subassembly 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; and wherein the processor is configured to identify the expelled or selected amount of contained medicament by detecting a position of the information tag via the tag reader.

[0015] Preferably, according to another embodiment, the rotator is a rotational drive.

[0016] Preferably, according to another embodiment, 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.

[0017] Preferably, according to another embodiment, 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.

[0018] Alternatively, according to another embodiment, 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.

[0019] Preferably, according to another embodiment, the rotatable driver comprises a driver body threadedly engaged with the plunger rod. Preferably, according to another embodiment, the rotatable driver is configured to be rotated by the user to select the predetermined amount of contained medicament.

[0020] Preferably, according to another embodiment, 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.

[0021] Preferably, according to another embodiment, the rotatable driver is configured to be manually moved in the proximal direction relative to the housing by the user.

[0022] Alternatively, according to another embodiment, 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.

[0023] Preferably, according to another embodiment, the sub-assembly comprises a user dial movably attached to the housing.

[0024] Preferably, according to another embodiment, 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.

[0025] Preferably, according to another embodiment, 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.

[0026] Preferably, according to another embodiment, the rotator is accommodated in the powerpack housing.

[0027] Preferably, according to another embodiment, 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.

[0028] Preferably, according to another embodiment, the medicament container is accommodated in the container housing.

[0029] Preferably, according to another embodiment, wherein the powerpack housing is attached to the container housing. Preferably, according to another embodiment, the tag reader comprises two receiving units configured to read the information contained in the information tag.

[0030] Preferably, according to another embodiment, the two receiving units are positioned opposite to one another in a direction transverse to the longitudinal axis.

[0031] Preferably, according to another embodiment, the two receiving units are two RFID / NFC antennas.

[0032] Preferably, according to another embodiment, 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.

[0033] Preferably, according to another embodiment, 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.

[0034] Preferably, according to another embodiment, 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.

[0035] Preferably, according to another embodiment, 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.

[0036] Preferably, according to another embodiment, 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.

[0037] Preferably, according to another embodiment, the processor is configured to receive the information related to the medicament delivery device from the information tag.

[0038] Preferably, according to another embodiment, the tubular body of the cap comprises a proximal wall extending in the direction transverse to the longitudinal axis.

[0039] Preferably, according to another embodiment, the proximal wall of the tubular body of the cap is configured to seal the proximal end of the housing. Preferably, according to another embodiment, 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.

[0040] Preferably, according to another embodiment, the tubular body of the cap comprises an Ultraviolet shield extending around the longitudinal axis.

[0041] Preferably, according to another embodiment, the Ultraviolet shield is configured to shield the medicament container from Ultraviolet.

[0042] Preferably, according to another embodiment, the container housing is enclosed by the Ultraviolet shield when the cap is attached to the housing.

[0043] Preferably, according to another embodiment, 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.

[0044] Preferably, according to another embodiment, the medicament delivery member of the medicament delivery device is a needle or a spray nozzle.

[0045] Preferably, according to another embodiment, the medicament container of the medicament delivery device is a syringe, a cartridge or a collapsible bag.

[0046] Preferably, according to another embodiment, the medicament container of the medicament delivery device is made of glass material or plastic material.

[0047] Preferably, according to another embodiment, the medicament delivery device is an injection device, an inhalation device, or a medical sprayer.

[0048] Preferably, according to another embodiment, the medicament delivery device is an auto- injector.

[0049] Preferably, according to another embodiment, 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. 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-1a (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-1 a' (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)) , 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, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. 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.

[0050] 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.

[0051] 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, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B-lymphocyte cell adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 0X40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapies, or TOR therapies.

[0052] 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, DHAX, CALGB 8811 , HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini- BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0053] 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. 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.

[0054] Furthermore, 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 element, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.

[0055] BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0057] 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;

[0058] Fig. 3 schematically shows a perspective view of elements of the medicament delivery device of Fig 1;

[0059] Fig. 4 schematically shows a perspective view of the cap of the sub-assembly of Fig. 2; and

[0060] Figs 5A-5C schematically show perspective views of the sub-assembly in the first, second and third dose detection scenarios.

[0061] DETAILED DESCRIPTION

[0062] Figs 1-5C illustrate a sub-assembly of a medicament delivery device. Preferably, the medicament delivery device is a multi-use medicament delivery device. Namely, the medicament delivery device is designed to be used by a user to deliver medicament more than one time. For example, the medicament delivery device can be a reusable medicament delivery device. In this example, 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. In another example, the medicament delivery device can be a disposable medicament delivery device. In this example, 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. In this example, it is common that the user is required to attach a medicament delivery member before each medicament delivery. For example, the user needs to attach a new pen needle before each injection when the medicament delivery device is a multi-use injector.

[0063] As shown in Figs 1-2, 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. In one example, the medicament container is a syringe, and the delivery member is a needle. In this example, the needle is integral at a proximal end of the syringe. Alternatively, 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. Alternatively, 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. In one example, the medicament container is made of plastic. In a preferred example, as shown in Fig. 5, the housing

[0064] 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

[0065] I I and the proximal end of the housing 1. The medicament container M is accommodated in the container housing 11. The powerpack housing 10 is attached to the container housing 11. In a preferred example, the distal end of the container housing 11 is attached to the proximal end of the powerpack housing 10. In one example where the user can exchange the medicament container, the powerpack housing is releasably attached to the container housing, e.g., via a thread connection or a bayonet connection. Alternatively, in one example where the medicament delivery device is designed not to let the user exchange the medicament container, 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. In another preferred example, 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.

[0066] 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.

[0067] The sub-assembly further comprises a cap 2 removably attached to the housing 1.

[0068] As shown in Fig. 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. As shown in Fig. 4, 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. In a preferred example, 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. As the predetermined amount of contained medicament is expelled or selected in response to the rotation of the rotator 3, 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.

[0069] 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. On the other hand, 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., SurePal™. The energy source can be a spring, e.g., a compression spring, a torsion spring, a gas canister, or a motor.

[0070] 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. Usually, 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. On the other hand, the rotatable driver usually is a conjunction between the plunger rod and the dose drum. Namely the rotatable driver usually participates in both the amount of medicament selection operation and the selected medicament delivery operation. For example, 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.

[0071] In one example, the rotator is a rotational drive. In this example, 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. Alternatively, the rotator can be a dose drum configured to be used to set a dose to be delivered by the user. In this example, 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.

[0072] In one example, the rotational drive can be the rotatable plunger rod of the medicament delivery device. For example, 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. Alternatively, 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. In one example, the plunger rod is moved in the proximal direction relative to the housing by the rotation of the rotatable driver. Alternatively, 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.

[0073] In a preferred example, as shown in Fig. 3, 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. In one example, the rotatable driver is configured to be manually moved in the proximal direction relative to the housing by the user. Alternatively, in one example where the sub-assembly is used in the automatic medicament delivery device, 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. In one example, the rotatable driver 3 is connected to a user dial 8. Thus, when the user rotates the user dial 8 around the longitudinal axis L, the rotatable driver 3 is rotated by the user. As a result, 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. Alternatively, or additionally, the housing 1 may comprises a cam sleeve 12 having a helical cam engaged with a protrusion of the rotatable driver 3. In this example, 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. In one example where the sub-assembly comprises the energy source 6, the energy source 6 is a spring positioned between a ledge of the housing 1 and the rotatable driver 3. When the rotatable driver 3 is moved in the distal direction relative to the housing 1 as mentioned above, the spring 6 is tensioned between the rotatable driver and the housing 1. In a preferred example, 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. As a result, when the flexible arm of the rotatable driver 3 is distally moved past the retaining ledge of the housing 1 , the rotatable driver 3 is blocked from moving in the proximal direction relative to the housing 1 by the retaining ledge. In this example, the sub-assembly comprises a push button 7. When the user moves the push button in the proximal direction relative to the housing 1 , 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. As a result, the spring 6 moves the rotatable driver 3 linearly along with the plunger rod 4 in the proximal direction relative to the housing 1. Thus, the contained medicament is expelled. In the example, 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. In a preferred example, 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. In this example, preferably, 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.

[0074] In a preferred example, 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. Thus, in one example, 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). Alternatively, 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). In these two examples, the sub-assembly is suitable to be reusable. In this example, 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. In this example, the rotator is the rotational drive. As a result, when a new medicament container is accommodated within the housing 1, no information from the information tag can be read by the processor; or only a weak signal from the information tag can be detected by the processor. In this example, 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. Thus, the residual doses of contained medicament can be detected; and / or the delivered dose accuracy can be detected. Furthermore, in another example, 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. In one example, 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. In another example, two receiving units 23a, 23b receive signals with different strengths from the information tag 9. As a result, 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. As the information tag 9 is fixedly attached to the rotator 3, 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. 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. As a result, 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.

[0075] Furthermore, in another example, 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. Alternatively, or additionally, the switch can be a non-contact switch, e.g., a reed switch.

[0076] 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. Furthermore, in another example, 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. In one example, 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. In one example where the sub-assembly is used in a multi-use medicament delivery device, 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.

[0077] In another example, 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. As it is common that 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. In one example where the housing 1 comprises the powerpack housing 10 and the container housing 11 , when the cap 2 is attached to the housing 1 , the container housing 10 is enclosed by the Ultraviolet shield when the cap 2 is attached to the housing 1.

[0078] Furthermore, the cap may comprise an electronic set comprising the processor 22. In one example, 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.

[0079] In one example, the electronic set comprises a memory, and / or a clock, and / or an indicator and / or a sensor. In one example, 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. In one example, the indicator can be an acoustic indicator, such as a speaker or a buzzer. For example, 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. In one example, the sensor 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. In one example, 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.

[0080] Furthermore, the housing, as mentioned in any example, may be provided with (i.e. , molded in, molded with) a compound featuring persistently antimicrobial, antifungal, and / or antiviral properties. Alternatively, 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.

[0081] 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.

[0082] Some other aspects of the invention are defined by the following clauses.

[0083] 1. A sub-assembly of a medicament delivery device, the sub-assembly 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 wherein the processor is configured to identify the expelled or selected amount of contained medicament by detecting a position of the information tag via the tag reader. The sub-assembly according to clause 1 , wherein 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 sub-assembly according to clause 2, wherein 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 sub-assembly according to clause 2, wherein 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 sub-assembly according to clause 4, wherein 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. The sub-assembly according to clause 5, wherein the rotatable driver is configured to be manually moved in the proximal direction relative to the housing by the user. The sub-assembly according to clause 5, wherein the sub-assembly comprises an energy source accommodated within the housing; and wherein the rotatable driver is configured to be moved in the proximal direction relative to the housing by the energy source. The sub-assembly 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 sub-assembly according to any one of the preceding clauses, wherein 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 sub-assembly according to any one of the preceding clauses, wherein 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 sub-assembly according to any one of the preceding clauses, wherein 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 sub-assembly according to any one of the preceding clauses, wherein 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 sub-assembly according to a combination of clause 11 and clause 12, wherein 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 sub-assembly according to any one of the preceding clauses, wherein the processor is configured to receive the information related to the medicament delivery device from the information tag. The sub-assembly according to any one of the preceding clauses, wherein 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. The sub-assembly according to any one of the preceding clauses, wherein 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. The sub-assembly according to a combination of clauses 9 and 16, wherein the container housing is enclosed by the Ultraviolet shield when the cap is attached to the housing.

Claims

CLAIMS1. A sub-assembly of a medicament delivery device, the sub-assembly 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 wherein the processor is configured to identify the expelled or selected amount of contained medicament by detecting a position of the information tag via the tag reader.

2. The sub-assembly according to claim 1, wherein 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.

3. The sub-assembly according to claim 2, wherein 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.

4. The sub-assembly according to claim 3, wherein the rotatable driver comprises a driver body threadedly engaged with the plunger rod; whereinthe 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.

5. The sub-assembly according to claim 4, wherein the sub-assembly comprises an energy source accommodated within the housing; and wherein the rotatable driver is configured to be moved in the proximal direction relative to the housing by the energy source.

6. The sub-assembly according to any one of claims 2-5, 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.

7. The sub-assembly according to any one of the preceding claims, wherein 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.

8. The sub-assembly according to any one of the preceding claims, wherein 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.

9. The sub-assembly according to any one of the preceding claims, wherein the rotator is movable relative to the housing in the direction of the longitudinalaxis 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.

10. The sub-assembly according to any one of the preceding claims, wherein 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.

11. The sub-assembly according to a combination of claim 9 and claim 10, wherein 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.

12. The sub-assembly according to any one of the preceding claims, wherein the processor is configured to receive the information related to the medicament delivery device from the information tag.

13. The sub-assembly according to any one of the preceding claims, wherein 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.

14. The sub-assembly according to any one of the preceding claims, wherein 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.

15. The sub-assembly according to a combination of claims 7 and 14, wherein the container housing is enclosed by the Ultraviolet shield when the cap is attached to the housing.

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