Drug Delivery Device Subassembly

Abstract

A subassembly of a medication delivery device, the subassembly comprising a tubular housing, a carrier, a cap, and a carrier retraction assembly, the tubular housing extending along a longitudinal axis between a distal end and a proximal end, the cap being removably attached to the tubular housing and at least partially surrounding the carrier, the carrier being configured to receive a medication container of the medication delivery device, and the carrier being movable relative to the tubular housing in the direction of the longitudinal axis by the carrier retraction assembly during removal of the cap from the tubular housing from a proximal position where the carrier is at least partially disposed within the tubular housing to a distal position where the carrier is further within the tubular housing.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to a subassembly of a medication delivery device, and more particularly to a subassembly that includes a carrier retraction assembly. [Background technology]

[0002] Drug delivery devices, such as manual or automatic injectors, are commonly known for self-administration of medication by patients without formal medical training. For example, a patient suffering from diabetes may require repeated insulin injections, or a patient may require regular injections of other types of medication, such as growth hormone.

[0003] There are types of drugs that are packed in containers, such as cartridges, syringes, ampoules, canisters, or the like, that contain drugs in a liquid state that can be stored for a long period of time and are ready for immediate use. However, other types of drugs are mixtures of two substances, namely the drug (e.g., a liquid lyophilized, a liquid powdered, or a concentrated liquid) and a diluent (e.g., water, a dextrose solution, or saline). These types of drugs cannot be premixed and stored for a long period of time, because the drugs are unstable and can deteriorate and lose their effectiveness quickly. Therefore, the mixing must be performed within a limited period of time by the user, such as the patient himself, a doctor, a nurse, a hospital staff member, or a trained person, before a dose of the drug is delivered to the patient. Furthermore, some drugs undergo chemical changes during mixing. Such highly reactive drugs require specific treatment when mixed with a diluent, because excessive mixing forces will deteriorate the drug.

[0004] To facilitate this mixing, some mixing containers with at least two chambers, known as multi-chamber containers, have been developed. These multi-chamber containers consist of at least one first chamber containing the drug and a second chamber containing the diluent. The chambers are sealed with stoppers so that the drug is separated from the diluent and does not deteriorate. When mixing the drugs, a redirection passage between the chambers is opened just before administration, usually by depressing the distal stopper of the container and then the partition stopper somewhat. This passage allows the drug and the diluent to mix, thereby preparing the drug for delivery.

[0005] To facilitate self-administration of prescribed doses of medication by patients in an easy, safe and reliable manner, as well as facilitate administration of medication by hospital personnel in an equally facilitated manner, several automated and semi-automated devices have been deployed that incorporate these multi-chamber solutions for pre-delivery medication mixing. Summary of the Invention [Problem to be solved by the invention]

[0006] Although many of the commercially available devices and those mentioned above have their advantages, there is still room for improvement, particularly with regard to the safe mixing of drugs and the automated use of components and functions dedicated to the mixing sequence. [Means for solving the problem]

[0007] The invention is defined by the following claims, to which reference should now be made.

[0008] In the present disclosure, when the term "distal direction" is used, it refers to the direction facing away from the dose delivery site during use of the drug delivery device. When the term "distal portion / end" is used, it refers to the portion / end of the delivery device or the portion / end of a member of the delivery device that is located farthest from the dose delivery site during use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, it refers to the direction facing towards the dose delivery site during use of the drug delivery device. When the term "proximal portion / end" is used, it refers to the portion / end of the delivery device or the portion / end of a member of the delivery device that is located closest to the dose delivery site during use of the drug delivery device.

[0009] Additionally, the terms "longitudinal," "longitudinally," "axially," or "axial" refer to a direction extending along a device or component thereof, typically in the direction of the device and / or component's longest extension, from the proximal end to the distal end.

[0010] Similarly, the terms "lateral" and "laterally" refer to a direction that is generally perpendicular to the longitudinal direction.

[0011] Additionally, the terms "circumferential," "circumferential," or "circumferentially" refer to the circumference or direction of circumference relative to an axis, typically a central axis extending in the direction of the longest extension of a device and / or component. Similarly, "radial" or "radially" refers to a direction extending radially relative to this axis, and "rotation," "rotational," and "rotationally" refer to rotation relative to this axis.

[0012] Accordingly, there is provided a medication delivery device subassembly comprising a tubular housing, a carrier, a cap, and a carrier retraction assembly, the tubular housing extending along a longitudinal axis between a distal end and a proximal end, the cap removably mounted to the tubular housing and at least partially enclosing the carrier, the carrier configured to receive a medication container of the medication delivery device, and the carrier retraction assembly configured to move the carrier relative to the tubular housing in the direction of the longitudinal axis from a proximal position where the carrier is at least partially disposed within the tubular housing to a distal position where the carrier is further within the tubular housing.

[0013] Preferably, according to another embodiment, the carrier retraction assembly comprises a prestressed elastic member disposed between the carrier and the tubular housing and configured to extend in the direction of the longitudinal axis, the carrier comprising a distal stop surface, and the subassembly comprising a proximal stop surface located adjacent to the distal stop surface of the carrier when the cap is attached to the tubular housing and offset relative to the distal stop surface during removal of the cap from the tubular housing, whereby the carrier is moved from a proximal position to a distal position by the prestressed elastic member during removal of the cap from the tubular housing.

[0014] Preferably, according to another embodiment, the tubular housing comprises a fastener and the cap comprises a counter fastener releasably mounted to the fastener, the cap being movable relative to the tubular housing between a mounted position in which the fastener is fixed to the counter fastener and a disengaged position in which the fastener is not fixed to the counter fastener.

[0015] Preferably, according to another embodiment, the fastener and the counter-fastener form a bayonet or screw engagement.

[0016] Preferably, according to another embodiment, the proximal stop surface is located on the cap.

[0017] Preferably, according to another embodiment, the subassembly includes an adapter attached to a portion of the cap, the proximal stop surface being disposed on the adapter, and the adapter being rotatable about a longitudinal axis relative to the carrier.

[0018] Alternatively, according to another embodiment, the proximal stop surface is disposed on the tubular housing, the cap is rotatably fixed to the carrier by rotational engagement, and the cap is rotatable about the longitudinal axis relative to the tubular housing during removal of the cap from the tubular housing.

[0019] Preferably, according to another embodiment, the carrier is rotatably fixed to the tubular housing by rotational engagement.

[0020] Preferably, according to another embodiment, the rotational engagement is formed by at least one of: engagement between ribs, engagement between ribs and recesses, and engagement between ribs and notches.

[0021] Preferably, according to another embodiment, the tubular housing has a distal surface and the carrier has a proximal surface, and the prestressing elastic member engages the distal surface of the tubular housing at a proximal end of the prestressing member and engages the proximal surface of the carrier at a distal end of the prestressing member.

[0022] Preferably, according to another embodiment, the tubular housing comprises a proximal surface, the carrier comprises a distal surface, and the prestressing elastic member engages the distal surface of the carrier at a proximal end of the prestressing member and engages the proximal surface of the tubular housing at a distal end of the prestressing member.

[0023] Preferably, according to another embodiment, the prestressed elastic member is a compression spring.

[0024] Preferably, according to another embodiment, the subassembly includes a rod disposed within the tubular housing, the rod extending along a longitudinal axis between a proximal end and a distal end, the rod being fixed relative to the tubular housing in the direction of the longitudinal axis during removal of the cap from the tubular housing, and the proximal end of the rod configured to move the stopper of the drug container when the carrier is in a distal position.

[0025] Preferably, according to another embodiment, the rod is configured to expel a medicament contained within the medicament container.

[0026] Preferably, according to another embodiment, the rod is configured to be at least partially surrounded by a spring configured to expel the medicament contained in the medicament container.

[0027] Preferably, according to another embodiment, the subassembly is used in a drug delivery device comprising a multi-chamber drug container disposed within a carrier.

[0028] Preferably, according to another embodiment, the drug delivery device is an injection device, an inhalation device, or a medical nebulizer.

[0029] Preferably, according to another embodiment, the drug delivery device is an auto-injector.

[0030] Preferably, according to another embodiment, the drug delivery device is a pen-type injection device.

[0031] Preferably, according to another embodiment, the medication delivery device comprises a reusable part and a disposable part.

[0032] Preferably, according to another embodiment, the disposable portion of the medication delivery device is a cassette and the tubular housing, the cap, the carrier, and the carrier retraction assembly are part of the cassette.

[0033] Preferably, according to another embodiment, the auto-injector is configured to provide subcutaneous, intramuscular, or intravenous injection.

[0034] Another aspect of the invention provides a method of operating a medication delivery device, the method comprising the steps of providing a medication delivery device comprising a tubular housing, a carrier for receiving a medication container, a cap, and a carrier retraction assembly, the tubular housing extending along a longitudinal axis between distal and proximal ends, the cap being removably mounted to the tubular housing and at least partially enclosing the carrier, and removing the cap from the tubular housing, thereby triggering the carrier retraction assembly to retract the carrier further within the tubular housing.

[0035] In general, the drug delivery devices described herein can be used for the treatment and / or prevention of one or more of a number of different types of disorders.

[0036] Exemplary diseases include rheumatoid arthritis, inflammatory bowel disease (such as Crohn's disease and ulcerative colitis), hypercholesterolemia and / or dyslipidemia, cardiovascular disease, diabetes (such as type 1 or type 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (such as age-related macular degeneration, diabetic macular edema, etc.), These include, but are not limited to, uveitis, infections, bone diseases (e.g., osteoporosis, osteopenia, etc.), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplants, acute hypoglycemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immune deficiencies, chronic inflammatory demyelinating polyneuropathy, etc.), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease, etc.), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, factor V Leiden), and cancer.

[0037] Exemplary drug types that may be provided in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody drug conjugates, neutralizing antibodies, antagonists, radioligand therapeutics, radioisotope and / or nuclear medicine agents, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogs, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapeutics, cell or gene therapy agents, oncolytic viruses, or immunotherapeutics.

[0038] Exemplary drugs that can be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology agents, such as, for example, immune checkpoints, cytokines, chemokines, cluster of differentiation, interleukins, integrins, growth factors, clotting factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T cell receptors, B cell receptors, or costimulatory proteins.

[0039] Exemplary drugs that can be included in the delivery devices described herein include, for example, human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, C1 esterase modulators, bradykinin modulators, CC chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signaling 2 (Trop-2) modulators, cluster of differentiation 52 (CCR4) modulators, and / or other modulators. D52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed cell death ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T -lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin domain-containing-3 (TIM-3) modulators, T-cell immunoreceptor containing Ig and ITIM domain (TIGIT) modulators, V-domain Ig inhibitor of T-cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte activation gene 3 (LAG3;Cluster of differentiation 223 (also known as CD223) antagonists, Cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, Cluster of differentiation 47 (CD47) antagonists, Cluster of differentiation 30 (CD30) modulators, Cluster of differentiation 73 (CD73) modulators, Cluster of differentiation 66 (CD66) modulators, Cluster of differentiation w137 (CDw137) agonists, Cluster of differentiation 158 (CD158) modulators, Cluster of differentiation 27 (CD27) modulators, Cluster of differentiation 58 (CD58) modulators, Cluster of differentiation 80 (CD80) modulators, Cluster of differentiation 33 (CD33) modulators, Cluster of differentiation 159 (CD159 or NKG2) modulators, Glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, Growth arrest specificity protein 6 (GAS6) / AXL pathway modulators These include, but are not limited to, agents exhibiting a proposed mechanism of action, such as modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation w123 (CDw123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cell receptor 2 (HAVCR2) antagonists, cancer testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or OX40) modulators, adenosine receptor modulators, inducible T cell costimulatory factor (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor infiltrating lymphocyte (TIL) therapeutics, or T-cell receptor (TCR) therapeutics;

[0040] Exemplary drugs that may be included in the delivery devices described herein include etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-1a, interferon beta-1b, peginterferon beta-1a, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaphrine ... These include, but are not limited to, lutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixezumab, and immune globulin.

[0041] Exemplary drugs that can be included in the delivery devices described herein include, for example, ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, and the like. Further include, but are not limited to, oncology therapeutics such as brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

[0042] Exemplary drugs that may be included in the delivery devices described herein include any of the "generic" or biosimilar equivalents described above, and the molecular names described above should not be construed as being limited to the respective "innovator" or "branded" versions, such as in the non-limiting examples of the innovator drug adalimumab and biosimilars, such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0043] Exemplary drugs that may be included in the delivery devices described herein further include, but are not limited to, drugs used for adjuvant or neoadjuvant chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Exemplary chemotherapeutic agents include, by way of example and without 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.

[0044] Exemplary drugs that may be provided in the delivery devices described herein further include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g., hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as, for example, sterile water for injection (SWFI), 0.9% normal saline, 0.45% normal saline, 5% dextrose in water, 0.45% normal saline plus 5% dextrose, lactated Ringer's solution, heparin lock flush solution, 100 U / mL heparin lock flush solution, or 5000 U / mL heparin lock flush solution.

[0045] In addition, any pharmaceutical preparation including, but not limited to, any of the agents described herein is expected to be used with the delivery device described herein.For example, pharmaceutical preparations including a drug (or a pharma-ceutically acceptable salt thereof) as listed herein and a pharma-ceutically acceptable carrier are included.Such preparations may include one or more other active ingredients (such as a combination of one or more active drugs), or may be the only active ingredient present, and may also include a dispersion enhancer (e.g., animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration adjuster or enhancer, stabilizer, buffer, or other excipient that is administered separately or formulated together.

[0046] Exemplary drugs that can be included in the delivery devices described herein include, for example, 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 These include, but are not limited to, multidrug treatment regimens such as 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, VeIP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0047] Moreover, all terms used in the claims are to be interpreted according to their ordinary meaning in the art, unless expressly stated otherwise herein. All references to "elements, devices, components, means, etc." are to be openly interpreted as referring to at least one example of that element, device, component, means, etc., unless expressly stated otherwise.

[0048] Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0049] [Figure 1] FIG. 1 is a schematic perspective view of a drug delivery device comprising a subassembly of the present invention; [Diagram 2] 2 is a schematic diagram of the subassembly of FIG. 1 with the cap removed from the tubular housing. [Figure 3A] FIG. 2 is a schematic cross-sectional view of the subassembly of FIG. 1 in one configuration. [Figure 3B] 2 is a schematic cross-sectional view of the subassembly of FIG. 1 in another configuration. [Figure 4] FIG. 2 is a schematic perspective view of a tubular housing and carrier of the subassembly of FIG. 1. [Diagram 5] FIG. 2 is a schematic perspective view of a cap of the subassembly of FIG. 1. [Figure 6] FIG. 6 is a schematic perspective view of the cap of FIG. 5 having an adapter. [Figure 7A] 2 is a schematic diagram illustrating an exemplary operation sequence of the subassembly of FIG. 1. [Figure 7B] 2 is a schematic diagram illustrating an exemplary operation sequence of the subassembly of FIG. 1. [Figure 7C] 2 is a schematic diagram illustrating an exemplary operation sequence of the subassembly of FIG. 1. [Figure 8A] 2 is a schematic cross-sectional view of a drug delivery device comprising the subassembly of FIG. 1. [Figure 8B] 2 is a schematic cross-sectional view of a drug delivery device comprising the subassembly of FIG. 1. [Figure 9] FIG. 10 is a schematic perspective view of the drive mechanism of the drug delivery device of FIG. [Figure 10] FIG. 10 is a schematic perspective view of components of the drive mechanism of FIG. [Figure 11] FIG. 10 is a schematic cross-sectional view of the drive mechanism of FIG. [Figure 12A] 4 is a schematic cross-sectional view of another example of a subassembly of the present invention. FIG. [Figure 12B] 4 is a schematic cross-sectional view of another example of a subassembly of the present invention. FIG. [Figure 12C] 4 is a schematic cross-sectional view of another example of a subassembly of the present invention. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0050] 1-11 show a subassembly of a drug delivery device. The subassembly includes a tubular housing 1, a carrier 3, a cap 2, and a carrier retraction assembly. The tubular housing 1 extends along a longitudinal axis L between a distal end and a proximal end. The cap 2 is removably mounted to the tubular housing 1 and at least partially surrounds the carrier 3. The carrier 3 is configured to receive a drug container of the drug delivery device. The carrier retraction assembly of the subassembly is configured to retract the carrier 3 further into the tubular housing 1 during removal of the cap 2 from the tubular housing 1. The carrier retraction assembly is configured to move the carrier 3 relative to the tubular housing 1 in the direction of the longitudinal axis L from a proximal position where the carrier is at least partially disposed within the tubular housing 1 to a distal position where the carrier 3 is further within the tubular housing 1. The cap 2 is configured to cover a drug delivery member, such as a spray nozzle or a syringe needle, when the cap 2 is mounted to the tubular housing 1. The cap 2 may also partially cover the carrier when it is in the proximal position.

[0051] This subassembly can be used with a drug delivery device that includes a pre-filled syringe or that includes a cartridge that requires the user to attach a separate drug delivery member before using the drug delivery device.

[0052] The carrier retraction assembly is configured to retract the carrier 3 further into the tubular housing 1 during removal of the cap 2 from the tubular housing 1. For example, the carrier is partially disposed in the tubular housing when the carrier is in a proximal position, and is fully disposed in the tubular housing when the carrier is in a distal position. In this example, the cap can be transparent or configured with an observation aperture. In this example, when the subassembly of the present disclosure is used with a pre-filled syringe, the user can observe the drug delivery member before use when the carrier is in a proximal position, so that the user can check whether the spray nozzle or injection needle is damaged before use. When the user removes the cap, the carrier will be retracted further into the tubular housing, i.e., the carrier is moved to a distal position. This allows the drug delivery member to be protected by the tubular housing to avoid any damage to the drug delivery member and also to avoid any injury to the user.

[0053] Further, the subassembly of the present disclosure can be used with a drug delivery device that requires the expulsion of any air contained within the drug container, i.e., a priming shot. Further, the subassembly of the present disclosure can be used with a drug container that includes two or more isolated chambers, i.e., a multi-chamber drug container. These chambers are typically isolated from one another by rubber stoppers. The subassembly can be used to perform an automatic mixing function between substances in different chambers. When the subassembly is used with a drug delivery device that requires a priming shot and / or has an automatic mixing function, the subassembly further includes a rod 6 disposed within the tubular housing 1. The rod is axially immovable relative to the tubular housing 1 when the automatic mixing and / or priming shot is performed. The rod can be configured to move into the drug container and expel the drug into the user's body. In this example, the rod is typically referred to as a plunger rod. Alternatively, the rod 6 can be configured to support the plunger rod or to support a spring configured to expel the drug contained within the drug container. In other words, the rod itself will not move proximally relative to the tubular housing to expel the contained drug. In this example, the rod 6 will generally be referred to as a guide rod 6. The plunger rod and guide rod are described in more detail below.

[0054] In one example where the subassembly of the present disclosure is used to perform an automatic mixing function on a multi-chamber drug container, the carrier retraction assembly is configured to move the carrier from a proximal position to a distal position during removal of the cap from the tubular housing, thereby allowing the rod of the subassembly to act against a drug container stopper located at the distal end of the drug container when the carrier is in the distal position, thereby allowing the materials contained in the different chambers to be mixed. Similarly, when the subassembly of the present disclosure is used to perform a priming shot, the rod of the subassembly acts against a drug container stopper located at the distal end of the drug container when the carrier is in the distal position, thereby evacuating air contained in the drug container.

[0055] Thus, when the user removes the cap, the drug in the drug delivery device having the subassembly is ready for use, e.g., fully mixed and / or primed, without the need for additional operational steps to mix multiple substances and / or perform a priming shot.

[0056] Furthermore, most multi-chamber drug containers are cartridges, which means that the user needs to attach the drug delivery member before use. If the user attaches the drug delivery member to the drug container before completing the mixing operation, the pressure build-up in the drug container may cause the drug to leak through the drug delivery member during the mixing operation. The subassembly of the present disclosure uses a cap to enclose the carrier, so that the user cannot access and attach the drug delivery member to the drug container before performing the mixing. When the cap is removed, the mixing operation is also completed because the carrier is retracted during the removal of the cap. This means that the risk of drug leakage can be mitigated.

[0057] In the example shown in Figures 3A-3B, the carrier retraction assembly comprises a prestressed elastic member 4, for example a spring or a flexible arm. In the example presented, this prestressed elastic member 4 is a coil spring, for example a compression spring or a tension spring, the detailed configuration of which will be described in detail below. Alternatively, in another example where the spring is a band spring, the carrier retraction assembly may comprise the band spring, a fixture for mounting an end of the band spring either to the carrier 3 or to the tubular housing 1, and a pin around which the band spring is wound. Once the fixture is attached to the carrier, the pin can be mounted to the housing. Alternatively, once the fixture is mounted to the housing, the pin can be mounted to the carrier.

[0058] Alternatively, the carrier retraction assembly may be formed in any suitable manner to retract the carrier further into the housing during removal of the cap. For example, the carrier retraction assembly may be a gear and rack. Both the gear and rack may be disposed between the cap and the carrier, such that as the cap moves in a proximal direction, the gear moves the carrier distally via the rack to a distal position. Alternatively, the carrier retraction assembly may be a motor gear having a switch configured to be turned on by removal of the cap, such that when the switch is turned on, the motor gear can move the carrier to a distal position.

[0059] In one embodiment where the retraction assembly comprises a prestressed resilient member, the cost of the subassembly can be reduced compared to embodiments where the retraction assembly comprises a gear and rack or a motor gear and switch.

[0060] It should be noted that how far the carrier should be retracted into the housing (i.e., the distance between the proximal and distal positions as measured in the direction of the longitudinal axis L) is design dependent. For example, if the subassembly is used in a drug delivery device configured to retract a prefilled syringe further into the housing during cap removal, the retraction distance of the carrier should be equal to or greater than the length of the drug delivery member. For example, the drug delivery member is a needle with a length of 13 mm. In this case, the retraction distance of the carrier can be set to 15 mm for the needle length of 13 mm. Alternatively, if the subassembly is used in a drug delivery device to perform a priming shot, the retraction distance of the carrier depends on the volume of the priming shot, which usually depends on the drug contained and the drug filling process, such as the amount of gas to be generated or the amount of air to be trapped in the drug container. Alternatively, when the subassembly is used in a drug delivery device, the subassembly is configured to perform an automatic mixing operation, and the retraction distance of the carrier depends on the length required to completely push the substance in one or two chambers into another chamber. This length depends on the type of substance, e.g., liquid or powder, viscosity, volume amount, and the number of chambers provided. The retraction distance of the carrier can be fixed by any suitable configuration. For example, the retraction distance of the carrier can be fixed by arranging ribs and grooves between the outer surface of the carrier and the inner surface of the tubular housing. Alternatively, the retraction distance of the carrier can be fixed by the carrier retraction assembly. For example, when the carrier retraction assembly includes a gear and a rack, the retraction distance of the carrier can be fixed by the length of the rack or the number of teeth of the gear. In another example, the retraction distance of the carrier can be changed by changing the accumulated force of the prestressed elastic member.

[0061] A preferred embodiment of the subassembly of the present disclosure will now be described in detail.

[0062] As shown in Figure 1, the tubular housing 1 extends along a longitudinal axis L between a distal end and a proximal end. The tubular housing 1 is configured to receive a carrier 3 and to couple to a drive mechanism of a drug delivery device, which will be described in detail below.

[0063] The carrier 3 is configured to receive the drug container of the drug delivery device and is partially disposed within the tubular housing 1 from the proximal end of the tubular housing 1 as shown in FIG. 2. In this example, the carrier 3 is generally cylindrical with a distal surface at its proximal inner section to support the shroud section of the drug container. Alternatively, the carrier 3 can be of any suitable shape capable of accommodating the drug container. For example, most drug containers are cylindrical, so the carrier can also be cylindrical. In another example, a drug container with two or more chambers has a bump on its outer surface as a bypass, so that when a substance in one chamber is pressed, the substance can flow through the bypass into another chamber. As a result, the carrier can be a tube or be dimensioned to receive the drug container, such that a drug container with one or more bumps can be received within the carrier. Alternatively, the carrier can be a ring or circlip clamped onto the outer surface of the drug container.

[0064] The cap 2 is removably attached to the tubular housing 1 as shown in Figs. 1-2 and partially surrounds the carrier 3. In a preferred example, the cap 2 and the carrier 3 are transparent so that the user can easily observe the drug container in the carrier 3. Alternatively, the cap comprises an observation window. In the example shown in Figs. 1-2, the cap 2 is tubular and has a generally elliptical cross section when viewed along the longitudinal axis L, so that the drug delivery device will not roll when placed on a flat surface. Alternatively, the cap 2 can be of any suitable shape depending on the shape of the carrier and / or the shape of the housing and / or the target user group. For example, the cap can be tubular, cup-shaped, or cone-shaped. Furthermore, in the example shown in Figs. 3A-3B, the cap 2 and the tubular housing 1 are configured to surround the entire carrier 3. In this example, the tubular housing 1 comprises a fastener 13 as shown in Fig. 4, and the cap 2 comprises a counter fastener 22 releasably attached to the fastener 13. The fastener 13 is arranged on the outer surface of the tubular housing wall and the counter fastener 22 is arranged on the inner surface of the cap wall. In this example, the cap 2 is movable relative to the tubular housing 1 between an attached position, in which the fastener 13 is fixed relative to the counter fastener 22, and a disengaged position, in which the fastener 13 is not fixed relative to the counter fastener 22. The fastener 13 and the counter fastener 22 form a bayonet or threaded engagement. In this example, the cap 2 is configured to be removed from the housing by rotation about the longitudinal axis L and a subsequent axial movement in the proximal direction relative to the tubular housing 1. Alternatively, in another example, the fastener can be a recess / notch and the counter fastener can be a bump positioned in the recess / notch. In this example, the cap 2 is configured to be removed from the tubular housing 1 by axial movement in the proximal direction relative to the tubular housing 1.

[0065] The carrier retraction assembly is configured to move the carrier 3 from a proximal position to a distal position during removal of the cap from the tubular housing 1. In this preferred embodiment, the carrier retraction assembly includes a prestressed resilient member 4 disposed between the carrier 3 and the tubular housing 1 as shown in Figures 3A-3B. In this embodiment, the carrier 3 includes a distal stop surface 32 and the subassembly includes a proximal stop surface that is adjacent to the distal stop surface 32 of the carrier 3 when the cap 2 is mounted on the tubular housing 1 and is offset relative to the distal stop surface 32 during removal of the cap 2 from the tubular housing 1. As discussed above, removal of the cap from the tubular housing may include rotational and axial movement of the cap relative to the tubular housing, or only axial movement of the cap relative to the tubular housing. The carrier retraction assembly can be actuated by rotational motion only, axial motion only, or both, i.e., the proximal stop surface is offset relative to the distal stop surface 32 when the cap is rotated about its longitudinal axis relative to the tubular housing, moved axially relative to the tubular housing, or both, depending on the design.

[0066] The distal stop surface 32 of the carrier 3 may be defined by a distal edge of the carrier, a protrusion 33 on the outer surface of the carrier 3 as shown in FIG. 4, or an edge of a recess / notch located in a sidewall of the carrier.

[0067] In one example, the proximal stop surface 12 is disposed on the tubular housing 1 as shown in FIG. 4, and the cap 2 is rotatably fixed to the carrier 3 via a rotational engagement (which may be formed as the rotational engagement of the above-mentioned example), so that the cap rotates with the carrier about the longitudinal axis L. For example, as shown in FIGS. 4-5, a rib 33 is formed on the outer surface of the side wall of the carrier 3, and a counter rib 21 is formed on the inner surface of the side wall of the cap 2. In this example, the cap 2 is rotatable about the longitudinal axis L relative to the tubular housing 1 during removal of the cap from the tubular housing 1. In this example, the cap 2, when rotating, further rotates the carrier 3 via the rotational engagement with the carrier 3. This rotates the carrier 3 to offset the distal stop surface 32 from the proximal stop surface 12 of the tubular housing 1 in the direction of the longitudinal axis L.

[0068] In another example, as shown in FIG. 6, the proximal stop surface 51 is disposed on the adapter 5, and rotation of the cap 2 results in rotation of the proximal stop surface 51 relative to the distal stop surface 32 of the carrier 3. In this example, there is no rotational connection between the cap 2 and the carrier 3, and as a result, the cap 2 can rotate relative to the carrier 3 about the longitudinal axis L. For example, the cap can have a diameter large enough such that the inner surface of the cap does not contact the outer surface of the carrier except for the proximal stop surface. Alternatively, in a preferred example, the carrier 3 is rotatably fixed to the tubular housing 1 through a rotational engagement. This rotational engagement can be formed by rib-to-rib engagement, rib-to-recess engagement, or rib-to-notch engagement. For example, the carrier includes a rib disposed on the outer surface of the carrier's sidewall, and a recess disposed on the inner surface of the tubular housing's sidewall. The rib of the carrier is positioned within the recess on the inner surface of the tubular housing's sidewall, such that the carrier cannot be rotated relative to the tubular housing. Alternatively, the rotational engagement may be a shape match between the carrier and the tubular housing, for example the carrier may be elliptical, rectangular, or triangular when viewed along the longitudinal axis L, and the tubular housing may be a corresponding elliptical, rectangular, or triangular shape when viewed along the longitudinal axis L.

[0069] Furthermore, in instances where the proximal stop surface 51 is located on the adapter 5, the subassembly need not be configured with a fixture on the tubular housing and a counter fixture on the cap as described above, since engagement between a distal stop surface on the carrier and a proximal stop surface on the cap or adapter allows the cap to remain attached to the tubular housing.

[0070] It should be noted that the proximal stop surfaces described above are also suitable for placement on the cap.

[0071] It is noted that this proximal surface may be located on any suitable component that is axially immovable relative to the housing, at least prior to removal of the cap from the housing. As discussed above, the proximal stop surface may be located on the cap, on the tubular housing, or on an adapter that is attached to the cap. The proximal stop surface may be defined by a ledge extending from an inner surface of a sidewall of the cap, tubular housing, or adapter, or by a recess / notch located in the wall of the cap, tubular housing, or adapter 5.

[0072] The proximal stop surface is configured to prevent distal movement of the carrier 3 in the direction of the longitudinal axis relative to the tubular housing 1 against a force from the prestressed elastic member 4 that moves the carrier 3 distally relative to the tubular housing 1. Relative rotation of the proximal and distal stop surfaces 32 of the carrier 3 about the longitudinal axis L is triggered during removal of the cap 2 from the tubular housing 1.

[0073] In one example where the cap 2 is configured to be removed from the tubular housing 1 by rotation about the longitudinal axis and axial movement in the proximal direction relative to the tubular housing 1, the proximal stop surface can be located on the cap, housing, or adapter 5. In a preferred example, the proximal stop surface is offset relative to the distal stop surface 32 when the cap 2 is rotated relative to the tubular housing 1 about the longitudinal axis L. In one example where the proximal stop surface 51 is located on the cap or adapter, the cap 2 is rotatable relative to the carrier, such that when the cap 2 is rotated relative to the tubular housing 1 about the longitudinal axis L to initiate removal of the cap, the rotation of the cap 2 causes the proximal stop surface 51 to be offset relative to the distal stop surface 32 of the carrier 3 in the direction of the longitudinal axis L.

[0074] Further, as shown in FIG. 4 and FIG. 6, the proximal stop surface 12(51) optionally comprises a concave portion 12a(51a) and / or a protruding portion 12b(51b). The concave portion 12a(51a) opens in the direction of the longitudinal axis L. The protruding portion 12b(51b) extends in the direction of the longitudinal axis L. The concave portion 12a(51a) is configured to prevent unintended relative rotation between the distal stop surface 32 of the carrier 3 and the proximal stop surface 12(51). In a preferred example, the distal stop surface 32 is convex, and the concave portion 12a(51a) of the proximal stop surface 12(51) is concave to match this convex surface. Thus, potential unintended relative rotation between the distal stop surface 32 of the carrier 3 and the proximal stop surface 12(51), for example when the subassembly is subjected to vibration, can be prevented. The protruding portion 12b;51b of the proximal stop surface 12(51) is configured to limit the rotational direction of the relative rotation between the distal stop surface 32 of the carrier 3 and the proximal stop surface 12(51). Thus, distal movement of the carrier to a distal position can be triggered only when the proximal stop surface 12(51) is rotated in one direction relative to the distal stop surface 32 of the carrier 3 or when the distal stop surface 32 of the carrier 3 is rotated in one direction relative to the proximal stop surface 12(51).

[0075] Further, in one example where the proximal stop surface 51 is disposed on the adapter 5, which is a component attached to the cap 2, the cap can be arranged to be removed from the housing by either rotational and axial motion or axial motion only. For example, the adapter (e.g., ring, circlip, or cylinder) is disposed within the cap. In one example, the adapter includes a helical track or helical cam surface, and the cap includes a protrusion extending from an inner surface of the side wall of the cap. This protrusion of the cap is configured to engage the helical track or helical cam surface. Thus, during removal of the cap from the tubular housing, the protrusion of the cap will move along the helical track or helical cam surface, which causes the axial motion of the cap to rotate the adapter. This rotation of the adapter positions the proximal stop surface offset relative to the distal stop surface of the carrier. Alternatively, the cap can be configured with a helical track or helical cam surface, and the adapter can be configured with a protrusion, depending on the design choice.

[0076] In another example, the adapter 5 is rotated by the cap 2 rotating relative to the tubular housing. In this example, the adapter can simply be fixed relative to the cap or can be arranged to rotate relative to the cap at a different speed or angle of rotation relative to the tubular housing. In an example where the adapter is fixed relative to the cap, this example can provide manufacturing efficiencies since the cap can be standardized for most drug delivery devices. In an example where the adapter is arranged to rotate relative to the cap at a different speed or angle of rotation relative to the tubular housing, this example can provide greater design freedom. For example, the adapter is configured with a circumferential groove and the cap includes a protrusion positioned within the groove, which allows the cap to first rotate relative to the adapter, then contact the edge of the groove, and then the cap and adapter rotate together. In this example, if the user begins to rotate the cap but then decides not to immediately perform the drug dispensing operation, retraction of the carrier will not be triggered. Alternatively, a similar effect can be achieved by a design with a length of the proximal stop surface in the circumferential direction.

[0077] In one example, the carrier retraction assembly comprises a prestressed elastic member 4 disposed between the carrier and the tubular housing. In one example, the prestressed elastic member is a compression spring 4, as shown in Figs. 3A-3B, which extends along a longitudinal axis between a proximal end and a distal end. As shown in Figs. 3A-3B, the tubular housing 1 comprises a distal surface 11 and the carrier 3 comprises a proximal surface 31. The prestressed elastic member 4 engages the distal surface 11 of the tubular housing 1 at its proximal end and engages the proximal surface 31 of the carrier 3 at its distal end. Thus, when the carrier 3 is in a proximal position as shown in Fig. 3A, the distal stop surface 32 of the carrier 3 is located adjacent to the proximal stop surface 12;51, the prestressed elastic member 4 is stressed, and the portion X1 of the carrier 3 is disposed within the tubular housing 1 as shown in Fig. 3A. When the distal stop surface 32 of the carrier 3 is offset relative to a proximal stop surface (e.g., on the housing, on the cap, or on the adapter), the compression spring 4 relaxes, thus pushing the carrier 3 to its distal position as shown in Fig. 3B. The carrier 3 is moved further into the tubular housing 1, and a portion X2 of the carrier 3 is disposed within the tubular housing 1. This portion X2 is longer than portion X1 as measured in the direction of the longitudinal axis L, and the retraction distance of the carrier 3 is defined by the difference between X1 and X2.

[0078] Alternatively, the prestressed elastic member is a flexible arm arranged between the tubular housing and the carrier in the direction of the longitudinal axis L. Alternatively, the prestressed elastic member 4 is a tension spring.

[0079] In one example where the prestressed elastic member is a tension spring, the tension spring extends along the longitudinal axis L between a proximal end and a distal end. The tubular housing has a proximal surface and the carrier has a distal surface. The prestressed elastic member engages the distal surface of the carrier at its proximal end and engages the proximal surface of the tubular housing at its distal end. Thus, when the distal stop surface of the carrier is offset relative to the proximal stop surface (e.g., on the housing, on the cap, or on the adapter), the tension spring can draw the carrier further into the tubular housing. The tension spring can be, for example, a coil tension spring or a stress band spring.

[0080] Another example of a subassembly of the invention as shown in Figures 12A-12C. In this example, the tubular housing 1' comprises an inner wall 10' facing towards the longitudinal axis L of the tubular housing 1'. In a preferred example, the inner wall 10' is located closer to the proximal end of the tubular housing 1' than to the distal end of the tubular housing 1'. The cap 2' is removably mounted to the tubular housing 1'. In this example, the carrier 3' is axially and bi-directionally movable relative to the tubular housing 1' in the direction of the longitudinal axis L. As mentioned above, the carrier 3' is configured to receive the medicament container. In a preferred example, the carrier 3' is configured to partially receive the medicament container. In this example, the cap 2' comprises a flexible wall 20'. A protrusion 21' extends from the flexible wall 20' of the cap 2' towards the longitudinal axis L. The flexible wall 20' is positioned between the inner wall of the tubular housing 1' and the carrier 3' when the cap 2' is mounted thereon. The protrusion 31' of the flexible wall 20' of the cap 2' is aligned with the inner wall 10' of the tubular housing 1' transversely to the longitudinal axis L. Thus, the flexible wall 20' is at least partially adjacent to the inner wall 10' of the tubular housing 1' when the cap 2' is mounted thereon. The cap 2' comprises a protrusion extending from the flexible wall towards the longitudinal axis L. The protrusion 31' defines a proximal surface. The carrier 3' comprises a distal surface. In one example, the carrier 3' comprises a protrusion 30' extending towards the flexible wall of the cap 2', the distal surface being defined by this protrusion of the carrier 3'. Alternatively, a recess / notch is disposed in the carrier and opens towards the flexible wall of the cap, in this example the distal surface being defined by an edge of the recess / notch.

[0081] 12A-12B, the proximal surface of the cap 2' lies adjacent to the distal surface of the carrier 3' when the cap 2' is mounted to the tubular housing 1'. When the cap 2' is moved proximally relative to the tubular housing 1', the proximal surface of the cap 2' engages the distal surface of the carrier 3'. The interface formed between the proximal surface of the cap 2' and the distal surface of the carrier 3' forms an oblique angle with respect to the longitudinal axis L.

[0082] In this example, the carrier retraction assembly includes a resilient member 4', such as a compression spring 4'. The compression spring 4' extends from a proximal surface of the carrier 3' to a distal surface of the tubular housing 1', and the compression spring 4' is compressible between the proximal surface of the carrier 3' and the distal surface of the tubular housing 1'. In this example, the cap 2' is configured to be removed from the tubular housing 1' by being moved proximally relative to the tubular housing 1'. In a preferred example, the cap 2' is configured to be manually pulled proximally relative to the tubular housing 1' by a user. When the flexible wall 20' of the cap 2' is located adjacent to the inner wall 10' of the tubular housing 1', the inner wall 10' of the tubular housing 1' prevents the flexible wall of the cap 2' from bending radially outward relative to the longitudinal axis L, as shown in FIG. 12A. The proximal surface of the cap 2' engages the distal surface of the carrier 3', causing the cap 2' and the carrier 3' to move together proximally relative to the tubular housing 1'. The proximal movement of the carrier 3' compresses the compression spring 4', as shown in FIG. 12B. When the cap 2' is moved proximally a first predetermined distance D' relative to the tubular housing 1', the protruding portion of the flexible wall 20' of the cap 2' is no longer aligned with the inner wall 10' of the tubular housing 1', causing the flexible wall of the cap 2' to flex radially outwardly relative to the longitudinal axis L. Thus, the proximal surface of the cap 2' disengages from the distal surface of the carrier 3', and thus the cap 2' is disengaged from the tubular housing 1'. When the cap 2' is disengaged from the tubular housing 1', the compressed compression spring 4' biases the carrier 3' relative to the tubular housing 1' in the longitudinal direction from a proximal position to a distal position, as shown in Fig. 12C. The carrier 3' is moved a distance D'' from the proximal position to the distal position to achieve a priming and / or mixing operation.

[0083] It should be noted that instead of disposing the compression spring 4' between the carrier 3' and the housing 1', it is also possible to dispose the compression spring 4' between the carrier 3' and another component. For example, the subassembly comprises a drug delivery member guard 8. The drug delivery member guard 8 is telescopic with respect to the proximal end of the tubular housing 1'. The drug delivery member guard 8 is configured to surround the drug delivery member of the drug delivery device, e.g., a syringe needle, before and after the drug delivery operation, thereby preventing the drug delivery member from being contaminated and preventing the user from suffering any injury from the drug delivery member. In this example, instead of the housing 1', the carrier retraction assembly comprises a compression spring 4'. The compression spring 4' extends from the proximal surface of the carrier 3' to the distal surface 80 of the drug delivery member guard 8, and the compression spring 4' is compressible between the proximal surface of the carrier 3' and the distal surface 80 of the drug delivery member guard 8. In this example, the compression spring 4' is able to perform two functions: to draw the carrier 3' further into the tubular housing 1' and to move the drug delivery member guard 8 out of the tubular housing 1', thereby enabling the drug delivery member guard 8 to surround the drug delivery member.

[0084] In a preferred example, the flexible wall 20' of the cap 2' is a flexible arm.

[0085] Further, instead of pulling the cap relative to the tubular housing, the cap can be rotated about its longitudinal axis relative to the tubular housing and moved proximally of the tubular housing, For example, the cap can be attached to the tubular housing by a threaded engagement or a helical camming interface formed between the cap and the tubular housing.

[0086] In another example, when the drug container is a cartridge, the subassembly includes a drug delivery member assembly 9. As shown in Figs. 12A-12C, the drug delivery member assembly 9 includes a drug delivery member 91, a hub 92 fixed to the drug delivery member 91, and a sheath 93 sealing the drug delivery member. The hub 92 includes a fixture 92a, and the carrier 3' includes a counter fixture 31' configured to be mounted to the fixture of the hub 92. The hub 92 is movable relative to the tubular housing 1' in the direction of the longitudinal axis L. In a preferred example, the drug delivery member assembly 9 is partially surrounded by a compression spring 4'. The drug delivery member 91 is aligned with the carrier 3' in the direction of the longitudinal axis L. When the cap 2' is mounted to the housing 1', the drug delivery member 91 is spaced from the carrier 3' and disposed proximally relative to the carrier 3'. In one example, the drug delivery member assembly 9 is disposed on a distal surface of the housing 1'. Alternatively, the drug delivery member assembly is disposed on the distal surface of the drug delivery member guard 8 when the cap 2' is attached to the housing 1'. Thus, when the cap 2' is moved proximally relative to the housing 1', the cap 2' further moves the carrier 3' proximally relative to the housing 1' as described above. Thus, the carrier 3' is moved towards the drug delivery member assembly as shown in Figs. 12A-12B. When the carrier 3' is moved a second predetermined distance D', the fixture 92a of the hub is attached to the counter fixture 31' of the carrier 3'. The engagement formed between the fixture and the counter fixture can be a snap-fit ​​engagement or a press-fit engagement as shown in Figs. 12A-12C. When the carrier 3' is attached to the hub of the drug delivery member assembly 9, the drug delivery member 91 is in fluid communication with the drug container in the carrier 3' as shown in Fig. 12C.

[0087] In a preferred example, the drug delivery member 91 is a syringe needle.

[0088] Note that this first predetermined distance can be the same or different from the second predetermined distance depending on the design.

[0089] Moreover, in one preferred example, the carrier 3' comprises a proximal support surface 32' configured to lie adjacent the distal end of the medicament container. Additionally, the carrier 3' optionally comprises a distal support surface 33' configured to lie adjacent the proximal shoulder of the medicament container.

[0090] 7A-7C show an operation sequence of one example of a subassembly. In this example, the cap 2 is configured to be removed from the tubular housing 1 by rotating it about its longitudinal axis L relative to the tubular housing 1 and axially moving it in a proximal direction relative to the tubular housing 1. FIG. 7A shows the carrier 3 in a proximal position. When the cap 2 is rotated about its longitudinal axis L relative to the tubular housing 1, a relative rotation is caused between the distal stop surface 32 and the proximal stop surface 12;51 of the carrier 3. Thus, the prestressed elastic member 4 moves the carrier 3 to a distal position, as shown in FIG. 7B.

[0091] In one example where the subassembly can perform automatic mixing or priming, the subassembly includes a rod 6. The rod 6 is disposed in the tubular housing 1. The rod 6 extends along a longitudinal axis L between a proximal end and a distal end. The rod 6 is fixed relative to the tubular housing 1 in the direction of the longitudinal axis during removal of the cap from the housing 1. As shown in FIG. 8B, the proximal end of the rod 6 is configured to move the stopper of the drug container when the carrier 3 is in a distal position. Furthermore, as shown in FIG. 8A, the proximal end of the rod 6 can engage the stopper of the drug container when the carrier 3 is in a proximal position, thereby preventing the impact that normally occurs when the rod 6 hits the stopper, which may damage the drug container. On the other hand, the proximal end of the rod can be spaced away from the stopper when the carrier is in a proximal position, so that when a drug delivery device having a subassembly of the present disclosure is transported by air cargo, even if the stopper moves due to changes in atmospheric pressure, the stopper will not be blocked by the rod (which could result in unintended drug release or mixing).

[0092] In the example as shown in Figures 8A-8B, the rod can be a guide rod 6 for a drug delivery device comprising the subassembly of the present disclosure, i.e. the rod 6 is configured to be surrounded by a spring 72 configured to expel a drug contained in a drug container. In this example, as shown in Figures 8A-8B, the guide rod 6 protrudes from a proximal end of a plunger rod 71 of the drug delivery device before the drug delivery operation is initiated. Alternatively, the rod is a plunger rod. The rod can be a plunger rod for a drug delivery device comprising the subassembly of the present disclosure, i.e. the rod is configured to expel a drug contained in a drug container.

[0093] In one example where the rod is a guide rod, this example is suitable for use with a drug delivery device in which the plunger rod is always subjected to a force for expelling the contained drug, such as a linear spring force, because when the plunger rod is pushed by the stopper of the drug container during retraction of the carrier, this pushing force may disengage the plunger rod from the retaining member (this will be described in detail below), which may cause an unintentional triggering of a drug delivery operation if the plunger rod is always subjected to a force for expelling the contained drug. In one example where the rod is a plunger rod, this example is suitable for use with a drug delivery device in which the plunger rod is not always subjected to a force for expelling the contained drug, such as a motor-driven power source or a gas-propelled power source, because these power sources / power sources do not normally output a force to the plunger rod unless the drug delivery device is triggered.

[0094] 8A-8B, the rod 6 is an elongated rod-shaped component. Alternatively, the rod 6 (plunger rod or guide rod) can be formed in any suitable shape depending on the design, for example depending on the power source selection of the drug delivery device and / or depending on the volumetric amount of drug to be contained.

[0095] The subassembly of the present disclosure can be used with a drug delivery device comprising a drive mechanism. The drive mechanism of the drug delivery device comprises a power source, a force transmitting member, and a trigger assembly. The power source is configured to provide a force for expelling a contained drug of the drug delivery device. The force transmitting member is configured to transmit force from the power source to the drug container. The trigger assembly is configured to either releasably hold the force transmitting member or control the output from the power source.

[0096] In a preferred example shown in Figs. 8A-11, the rod 6 of the subassembly is also a guide rod 6 for the drive mechanism. The plunger rod 71 described below is not part of the subassembly as mentioned above. In a preferred example shown in Figs. 9-10, the drive mechanism 7 includes a plunger rod 71 (in this example, the plunger rod is a force transmitting member), a plunger rod spring 72 (in this example, the plunger rod spring is a power source), an actuator 73, an actuator sleeve 74, and a button 75. In this example, a trigger assembly is formed by the actuator 73, the actuator sleeve 74, and the button 75. The button 75 is disposed at the distal end of the tubular housing 1 as shown in Fig. 11 and is axially movable relative to the tubular housing 1 between an initial position and a trigger position. The plunger rod 71 is configured to be biased by the plunger rod spring 72, thereby expelling the drug contained in the drug container when the button 75 is in the trigger position. The actuator 73 is configured to releasably engage with the plunger rod 71. The actuator sleeve 74 is configured to release the engagement between the actuator 73 and the plunger rod 71 when the button 75 is in the trigger position. The plunger rod 71 includes a distal support surface and a proximal retention surface 71a. The actuator 73 includes a body 731, 732 and a flexible arm 732a extending from the body 731, 732. The body 731, 732 includes a proximal support surface. The flexible arm 732a includes a distal retention surface adjacent to the proximal retention surface 71a of the plunger rod 71. The plunger rod spring 72 has a proximal end adjacent to the distal support surface of the plunger rod 71 and a distal end adjacent to the proximal support surface of the actuator 73. The actuator sleeve 74 includes a sleeve body aligned with the flexible arm 732a of the actuator 73 in a transverse direction to the longitudinal axis L. The drive mechanism 7 optionally includes a safety mechanism formed by a biasing member 76 disposed between the actuator 73 and the actuator sleeve 74 in the direction of the longitudinal axis L as shown in FIG. 9 and an enlarged portion on the outer surface of the flexible arm 732a of the actuator 73.Thus, the flexible arm 732a can only be offset relative to the sleeve body of the actuator sleeve by moving axially in the proximal direction relative to the actuator sleeve 74, and the biasing member 76 is configured to prevent the flexible arm 732a of the actuator 73 from unintentionally moving in the proximal direction relative to the actuator sleeve 74.

[0097] The button 75 is configured to move the flexible arm 732a of the actuator 73 to be axially offset relative to the sleeve body of the actuator sleeve 74 when the button 75 is moved from the initial position to the trigger position. In one example, the button 75 is configured to engage the bodies 731, 732 of the actuator 73 and move the bodies 731, 732 of the actuator 73 from the body sleeve of the actuator sleeve 74. Optionally, in this example, the bodies 731, 732 are formed by a proximal body 732 and a distal body 731. The flexible arm 732a extends from the proximal body 732. The distal body 731 includes a resilient arm 731a extending from the distal body 731. As shown in FIG. 10, the resilient arm 731a includes a protrusion 731b extending transversely to the longitudinal axis and a hook 731c including a proximal hook surface. In this example, the distal end of the carrier 3 is configured to engage the proximal end 74a of the actuator sleeve 74 and move the actuator sleeve distally relative to the tubular housing 1 when the carrier 3 is retracted further into the tubular housing 1. The distal portion of the sleeve body of the actuator sleeve 74 is configured to compress the resilient arm 731a radially relative to the longitudinal axis L when the carrier 3 moves the actuator sleeve 74 distally relative to the tubular housing 1. As shown in FIG. 11, the hook 731c will be blocked by the distal wall 14 of the tubular housing 1 when the button 75 pushes the actuator 73 proximally relative to the tubular housing 1 before the resilient arm 731a is radially compressed relative to the longitudinal axis L. The arrangement as defined in this example provides an optional safety mechanism, whereby the button 75 can be pressed to trigger a drug delivery operation only when the carrier is retracted further into the tubular housing 1.

[0098] Alternatively, in another example, the button is configured to engage and move the plunger rod proximally of the tubular housing, whereby the plunger rod moves the body of the actuator from the body sleeve of the actuator sleeve via engagement between the plunger rod and the actuator. In one preferred example, the actuator is configured to surround the plunger rod. The plunger rod includes an elongated body configured to releasably prevent the flexible arms of the actuator from flexing radially inward relative to the body of the actuator, whereby the actuator engages the actuator sleeve and is prevented from moving distally of the tubular housing until the elongated body of the plunger rod moves from the body of the actuator.

[0099] In another example, a drug delivery device having a drive mechanism as described above includes an indication mechanism. In this example, the plunger rod spring 72 is disposed between the plunger rod 71 and the actuator 73 as shown in FIG. 11. In this example, the flexible arm 732a of the actuator 73 includes an enlarged proximal end. When the plunger rod 71 is surrounded by the flexible arm 732a, the flexible arm 732a is blocked by the plunger rod 71 and thus cannot bend radially inward relative to the actuator sleeve 74. In this example, the actuator sleeve 74 is configured to engage the enlarged proximal end of the flexible arm 732a of the actuator 73 when the flexible arm 732a is supported by the plunger rod 71. In this example, the plunger rod spring 72 is configured to move the actuator 73 axially toward the distal end of the tubular housing 1, such that when the plunger rod 71 no longer supports the flexible arm 732a of the actuator 73, the flexible arm 732a flexes radially inward relative to the actuator sleeve 74. Thus, the enlarged portion of the flexible arm 732a of the actuator 73 is not blocked by the actuator sleeve 74. When the actuator impacts the inner surface of the tubular housing 1, an audible indication is generated. This audible indication can be a start indication or an end indication depending on the design, for example, by adjusting the length of the body of the actuator. For example, the actuator 73 is configured to provide an audible indication to indicate the end of the drug delivery operation. In this example, the flexible arm 732a of the actuator has a length measured in the direction of the longitudinal axis L that is approximately equal to the distance traveled by the plunger rod to empty the drug contained in the drug container in the direction of the longitudinal axis L. Thus, when the drug container is empty, the plunger rod is allowed to move completely out of the encircled state of the flexible arms 732 a of the actuator 73 , causing the flexible arms 732 a to flex radially inwardly relative to the actuator sleeve 74 .As a result, the actuator 73 may be biased in a distal direction relative to the tubular housing 1 by the plunger rod spring 72. When a portion of the actuator strikes a portion of the tubular housing, such as when the distal end of the protrusion 731b of the actuator 73 strikes the proximal end of the distal wall 14 of the tubular housing 1, an end indication, such as an end click, occurs.

[0100] It should be noted that, as an alternative to the above example, the drive mechanism of the drug delivery device may be formed in any other suitable manner. For example, instead of a plunger rod spring, the power source may be other types of springs, such as a torsion spring or a band spring. Alternatively, the power source may be a motor or a gas canister. Similarly, instead of being located in the tubular housing 1 as in the above example, the drive mechanism may be packaged in a separate power pack housing that couples to the tubular housing. In the example as shown in Figures 8A-8B, the tubular housing is cylindrical. Alternatively, it should be noted that the tubular housing 1 may be any suitable shape, depending for example on the size of the drive mechanism and the number of components of the drive mechanism. For example, the tubular housing may be rectangular or triangular when viewed along the longitudinal axis L.

[0101] Although the inventive concepts have been described above primarily with reference to certain examples, those skilled in the art will readily recognize that other embodiments than those disclosed above are equally possible within the scope of the inventive concepts, as defined by the appended claims.

[0102] In the following sections some further aspects of the invention are defined. 1. A subassembly of a drug delivery device comprising a tubular housing (1; 1'), a carrier (3; 3'), a cap (2; 2'), and a carrier retraction assembly (4; 4'). Equipped with The tubular housing (1;1') extends along a longitudinal axis (L) between a distal end and a proximal end, a cap (2;2') removably attached to the tubular housing (1;1') and at least partially surrounding the carrier (3;3'); the carrier (3;3') is configured to receive a drug container of a drug delivery device, The carrier retraction assembly is a subassembly configured to move the carrier (3;3') relative to the tubular housing in the direction of the longitudinal axis from a proximal position, where the carrier is at least partially disposed within the tubular housing (1;1'), to a distal position, where the carrier is further within the tubular housing. 2. The subassembly described in item 1, wherein the carrier (3) retraction assembly comprises an elastic member (4; 4'). 3. The subassembly described in item 2, wherein the prestressed elastic member (4) is disposed between the carrier (3) and the tubular housing (1) and is configured to extend in the direction of the longitudinal axis (L), the carrier (3) has a distal stop surface (32), and the subassembly has a proximal stop surface (12; 51) that is located adjacent to the distal stop surface (32) of the carrier (3) when the cap (2) is attached to the tubular housing (1) and that is offset relative to the distal stop surface (32) during removal of the cap (2) from the tubular housing (1). 4. The subassembly of any one of claims 1 to 3, wherein the tubular housing includes a fastener, the cap includes a counter fastener releasably mounted to the fastener, and the cap is movable relative to the tubular housing between an attached position in which the fastener is fixed to the counter fastener and a disengaged position in which the fastener is not fixed to the counter fastener. 5. The subassembly according to clause 4, wherein the fastener and the counter-fastener form a bayonet or threaded engagement. 6. The subassembly of any one of clauses 2 to 5, wherein the proximal stop surface is disposed on the cap. 7. A subassembly as described in any one of clauses 2 to 5, wherein the subassembly includes an adapter attached to a portion of the cap, the proximal stop surface being disposed on the adapter, and the adapter being rotatable about a longitudinal axis relative to the carrier. 8. The subassembly of any one of clauses 2 to 5, wherein the proximal stop surface is disposed on the tubular housing, the cap is rotatably secured to the carrier by rotational engagement, and the cap is rotatable about the longitudinal axis relative to the tubular housing during removal of the cap from the tubular housing. 9. The subassembly of any one of claims 1 to 7, wherein the carrier is rotatably fixed relative to the tubular housing by rotational engagement. 10. The subassembly of claim 8 or 9, wherein the rotational engagement is formed by at least one of engagement between ribs, engagement between ribs and recesses, and engagement between ribs and notches. 11. A subassembly as described in any one of paragraphs 3 to 10, wherein the tubular housing has a distal surface, the carrier has a proximal surface, and the prestressing elastic member engages the distal surface of the tubular housing at a proximal end of the prestressing member and engages the proximal surface of the carrier at a distal end of the prestressing member. 12. The subassembly of any one of claims 2 to 10, wherein the elastic member is a compression spring. 13. The subassembly of any one of clauses 1 to 12, wherein the subassembly includes a rod disposed within the tubular housing, the rod extending along a longitudinal axis between a proximal end and a distal end, the rod being fixed relative to the tubular housing in the direction of the longitudinal axis during removal of the cap from the tubular housing, and the proximal end of the rod is configured to move the stopper of the drug container when the carrier is in a distal position. 14. The subassembly of claim 14 or 15, wherein the rod is configured to be at least partially surrounded by a spring configured to expel a medicament contained within the medicament container. 15. The subassembly of claim 1 or 2, wherein the cap is configured to compress the resilient member during removal of the cap. 16. The subassembly of any one of paragraphs 1 to 15, comprising a drug delivery member guard that is telescopic relative to the tubular housing. 17. The subassembly according to claim 16, dependent on either claim 2 or a combination of claims 15 and 2, wherein the resilient member is configured to bias the drug delivery member guard in a proximal direction relative to the tubular housing. 18. A method of operating a drug delivery device, comprising: providing a medication delivery device comprising a tubular housing (1;1'), a carrier (3;3') for receiving a medication container, a cap (2;2') and a carrier retraction assembly (4;4'), the tubular housing (1;1') extending along a longitudinal axis (L) between a distal end and a proximal end, the cap (2;2') being removably mounted to the tubular housing (1;1') and at least partially surrounding the carrier (3;3'); removing the cap from the tubular housing, thereby triggering a carrier retraction assembly to retract the carrier further into the tubular housing; A method comprising: 19. The previous step of removing the cap is rotating the cap relative to the tubular housing about a longitudinal axis; pulling the cap in a proximal direction relative to the housing; 20. The method of claim 19, comprising, in the above order: [Explanation of symbols]

[0103] 1 Tubular housing 1' Tubular housing 2 Cap 2' Cap 3. Career 3' Carrier 4 Prestressed elastic member, compression spring, carrier retraction assembly 4' Elastic member, compression spring, carrier retraction assembly 5 Adapter 6 Rods, guide rods 7 Driving mechanism 8 Drug Delivery Component Guard 9 Drug Delivery Component Assembly 10 Inner wall 10' Inner wall 11 Distal Surface 12 Proximal Stop Surface 12a concave part 12b Projecting part 13 Fixtures 14 Distal wall 20 Flexible wall 20' flexible wall 21 Counter Rib 21' protrusion 22 Counter Fixtures 30 Protrusion 31 Proximal Surface 31' protrusion, counter fixing 32 Distal Stop Surface 32' Proximal Support Surface 33 Protrusions, ribs 33' Distal Support Surface 51 Proximal Stop Surface 51a Concave part 51b Projecting part 71 Plunger rod 71a Proximal Retention Surface 72 Plunger rod spring 73 Actuator 731 Distal body 731a Elastic Arm 731b Protrusion 731c Hook 732 Proximal Body 732a Flexible Arm 74 Actuator Sleeve 74a Proximal end 75 Button 76 Pressing member 80 Distal Surface 91 Drug delivery components 92 Hub 92a Fixture 93 Sheath X1 part X2 part

Claims

1. 1. A subassembly of a medication delivery device comprising: A tubular housing (1;1'), a carrier (3;3'), a cap (2;2'), and a carrier retraction assembly (4;4'). Equipped with The tubular housing (1;1') extends along a longitudinal axis (L) between a distal end and a proximal end, the cap (2;2') is removably attached to the tubular housing (1;1') and at least partially surrounds the carrier (3;3'); said carrier (3;3') is configured to receive a drug container of said drug delivery device, the carrier retraction assembly is a subassembly configured to move the carrier (3;3') relative to the tubular housing in the direction of the longitudinal axis from a proximal position, where the carrier is at least partially disposed within the tubular housing (1;1'), to a distal position, where the carrier is further within the tubular housing.

2. 2. The subassembly of claim 1, wherein the carrier (3) retraction assembly comprises a prestressed elastic member (4) disposed between the carrier (3) and the tubular housing (1) and configured to extend in the direction of the longitudinal axis (L), the carrier (3) comprises a distal stop surface (32), and the subassembly comprises a proximal stop surface (12; 51) located adjacent to the distal stop surface (32) of the carrier (3) when the cap (2) is mounted on the tubular housing (1), and the proximal stop surface (12; 51) is offset relative to the distal stop surface (32) during removal of the cap (2) from the tubular housing (1).

3. 3. The subassembly of claim 1 or 2, wherein the tubular housing includes a fastener, the cap includes a counter fastener releasably mounted to the fastener, and the cap is movable relative to the tubular housing between a mounted position in which the fastener is fixed to the counter fastener and a disengaged position in which the fastener is not fixed to the counter fastener.

4. The subassembly of claim 3 , wherein the fastener and the counter fastener form a bayonet or threaded engagement.

5. The subassembly of claim 2 , wherein the proximal stop surface is disposed on the cap.

6. 5. The subassembly of claim 2, further comprising an adapter attached to a portion of the cap, the proximal stop surface being disposed on the adapter, the adapter being rotatable about the longitudinal axis relative to the carrier.

7. 5. The subassembly of claim 2, wherein the proximal stop surface is disposed on the tubular housing, the cap is rotatably fixed to the carrier by rotational engagement, and the cap is rotatable about the longitudinal axis relative to the tubular housing during removal of the cap from the tubular housing.

8. The subassembly of claim 1 , wherein the carrier is rotatably fixed relative to the tubular housing by rotational engagement.

9. 9. The subassembly of claim 7 or 8, wherein the rotational engagement is formed by at least one of engagement between ribs, engagement between ribs and recesses, and engagement between ribs and notches.

10. 10. The subassembly of claim 2, wherein the tubular housing has a distal surface and the carrier has a proximal surface, and the prestressed elastic member engages the distal surface of the tubular housing at a proximal end of the prestressed elastic member and engages the proximal surface of the carrier at a distal end of the prestressed elastic member.

11. 11. The subassembly of claim 2, wherein the prestressed elastic member is a compression spring.

12. 12. The subassembly of claim 1, wherein the subassembly comprises a rod disposed within the tubular housing, the rod extending along the longitudinal axis between a proximal end and a distal end, the rod being fixed relative to the tubular housing in the direction of the longitudinal axis during removal of the cap from the tubular housing, and the proximal end of the rod configured to move a stopper of the drug container when the carrier is in the distal position.

13. 13. The subassembly of claim 12, wherein the rod is configured to be at least partially surrounded by a spring configured to expel a medicament contained within the medicament container.

14. 1. A method of operating a medication delivery device, comprising: providing a medication delivery device comprising a tubular housing (1;1'), a carrier (3;3') for receiving a medication container, a cap (2;2') and a carrier retraction assembly (4;4'), the tubular housing (1;1') extending along a longitudinal axis (L) between a distal end and a proximal end, the cap (2;2') being removably mounted to the tubular housing (1;1') and at least partially surrounding the carrier (3;3'); removing the cap from the tubular housing, thereby triggering the carrier retraction assembly to retract the carrier further into the tubular housing; A method comprising:

15. The step of removing the cap includes: rotating the cap relative to the tubular housing about the longitudinal axis; pulling the cap in a proximal direction relative to the housing; 15. The method of claim 14, comprising, in the above order:

Images