Drug delivery device subassembly

Abstract

Disclosed is a subassembly (2) of a drug delivery device (1) including a hub (22) adapted to displace a piercing element (212) from a first position spaced apart from a membrane (82) of a drug container (8) to a second position where the membrane (82) is pierced by the piercing element (212), thereby fluidly connecting the drug container (2) to a drug delivery element (211) of the subassembly (2). A first guide structure (221) of the hub (22) and a second guide structure (232) of a cap (23) for covering the drug delivery element (211) are adapted to engage with each other in such a manner that rotation of the cap (23) about a longitudinal axis (235) results in displacement of the hub (22) along the longitudinal axis (235) and displacement of the piercing element (212) from the first position to the second position.

Description

[Technical Field]

[0001] The present invention relates generally to medication delivery devices, such as cartridge injection devices, and in particular to subassemblies for such medication delivery devices. [Background technology]

[0002] A cartridge injection device, such as a cartridge auto-injector, typically has a sealed drug container that forms a cartridge and contains a drug. The device typically further includes a needle that is initially separated from the drug container. Prior to use of the injection device, the drug container is punctured by the puncturing portion of the needle to establish a fluid connection between the drug container and the drug delivery portion of the needle. A plunger can then be moved into the drug container to dispense the drug through the needle for injection into a user.

[0003] A particular challenge concerns the development of a drug delivery device that is not only easy to handle for the user but also particularly safe. In particular, for inexperienced patients or patients who require frequent injections, incorrect handling or malfunction of the device can lead to, for example, an incorrect dosage of the injected drug, device defects, or even injury. In this context, the drug delivery element, i.e., the needle through which the drug passes and is injected subcutaneously, poses a risk of injury to the patient. Therefore, in a cartridge injection device, it is desirable to achieve the necessary puncture of the cartridge with the needle in a manner as safe and simple as possible for the user.

[0004] In this regard, WO 2013 / 089616 (A1) discloses a device having a cap for covering a needle attached to a hub. When the cap is unscrewed, the hub is rotated along with the cap, thereby threading into the opposite female thread, allowing the needle to approach and ultimately puncture the cartridge. Similar mechanisms are disclosed in WO 2020 / 120087 (A1), WO 2021 / 148176 (A1), WO 2014 / 076225 (A1), and WO 2009 / 150078 (A1). Mechanisms with counter-threading, such as those disclosed in these documents, often have the disadvantage that the needle can be removed from the device by rotating the hub in the opposite direction after removing the cap.

[0005] Further cartridge injection devices having a mechanism for puncturing the cartridge with a needle are disclosed, for example, in WO 2022 / 106121(A1) and WO 2019 / 106202(A1).

[0006] U.S. Patent Application Publication No. 2020 / 0368436(A1) discloses an injection device having a housing with a guide slot for guiding a slot-engaging portion of a needle unit carrying a needle. To puncture the membrane of the cartridge with the needle, the needle unit needs to be rotated relative to the housing and along the guide slot. Therefore, in order to use the syringe, an additional step is required in addition to removing the cap.

[0007] U.S. Patent Application Publication No. 2018 / 0344934(A1) discloses a device with a cartridge holder having a guide pin that engages with a guide groove on a tubular member of an end cap. When the end cap is rotated to remove it from the device, the guide pin guides the needle holder through the tubular member and presses it against the cartridge. As a result, the cap can be removed after the membrane of the cartridge is pierced by the needle. This mechanism is less intuitive for users because the cap must first be moved further onto the device before it can be removed from the device. The design proposed in this document also requires complex components and a complicated assembly process. Summary of the Invention

[0008] It is an object of the present invention to provide a sub-assembly of a medication delivery device that is not only safe to use but also particularly intuitive and easy to handle. Furthermore, the sub-assembly should preferably be simple to manufacture.

[0009] This object is solved by a subassembly as defined in claim 1. Further embodiments of the subassembly are defined in the dependent claims. A drug delivery device comprising such a subassembly is defined in claim 12.

[0010] Accordingly, the present invention provides a sub-assembly of a medication delivery device for delivering medication from a medication container to a human or animal patient, the sub-assembly comprising: a drug delivery element having a proximal end through which a drug can be delivered to a patient; a piercing element for piercing a membrane of the medicament container to fluidly connect the medicament delivery element to the medicament container; a hub adapted to displace the piercing element from a first position, in which the piercing element is positioned away from the membrane of the medicament container, to a second position, in which the membrane is pierced by the piercing element; a cap for covering the proximal end of the drug delivery element before use of the drug delivery device.

[0011] The hub has a first guide structure and the cap has a second guide structure, the first guide structure and the second guide structure adapted to engage with each other in a manner such that rotation of the cap about the longitudinal axis results in displacement of the hub along the longitudinal axis and displacement of the puncturing element from the first position to the second position.

[0012] By providing the cap with a guide structure for displacing the hub, the movement required to remove the cap can be directly converted into a displacement of the hub, and thus into a puncture of the membrane by the puncture element. Therefore, no intermediate components are required to transfer the cap removal movement to a displacement of the hub. Because the cap directly drives the hub, the motion transfer is particularly effective. As a result, the force required by the user to remove the cap from the device and simultaneously puncture the membrane can be minimized. Furthermore, by appropriately designing the first and second guide structures, the desired motion transfer behavior can be achieved. For example, the guide structures can be designed so that the unscrewing movement of the cap in the proximal direction is converted into a displacement of the hub in the distal direction, resulting in a particularly intuitive and easy handling of the device for the user. Because no intermediate components are required for motion transfer, the subassembly can also be manufactured with a minimal number of components, thus in a particularly simple manner.

[0013] In this disclosure, when the term "distal direction" is used, it refers to the direction away from the dose delivery site during use of the drug delivery device. When the term "distal part / end" is used, it refers to the part / end of the delivery device, or part / end of a member thereof, that is located furthest from the dose or drug delivery site during use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, it refers to the direction towards the dose delivery site during use of the drug delivery device. When the term "proximal part / end" is used, it refers to the part / end of the delivery device, or part / end of a member thereof, that is located nearest to the dose delivery site during use of the drug delivery device.

[0014] Additionally, unless otherwise indicated, the terms "longitudinal," "longitudinally," "axially," and "axial" refer to a direction extending along a device or component thereof from the proximal end to the distal end, typically in the direction of the longest extension of the device and / or component.

[0015] Similarly, the terms "transverse," "transversal," and "transversally" refer to a direction generally perpendicular to the longitudinal direction.

[0016] The medication delivery device is preferably a cartridge injection device. Thus, the medication container including the membrane can typically be removed from the rest of the medication delivery device, in particular from the housing, e.g., after delivery of the medication, to be replaced with another filled medication container to be used for a subsequent injection. The membrane functions to seal the interior of the medication container, in which the medication is stored, from the outside. To enable injection of the medication into the patient, the membrane is usually pierced by a piercing element immediately before injection.

[0017] The drug delivery device can be, for example, an auto-injector, a pen-type injector, or a body-worn device. The drug delivery element is typically a cannula or hollow needle, also referred to as a needle for short. The drug delivery device is preferably adapted to be inserted proximal end first into a patient's skin for subcutaneous injection of the drug at a desired location within the patient's body. The drug is typically delivered from the drug container to the patient by means of advancing a plunger inside the container in a proximal direction. The plunger advancement can be performed manually, motor-driven, or, as preferred herein, by a spring, particularly a helical spring.

[0018] The drug delivery devices described herein can be used to treat and / or prevent one or more of many different types of diseases.

[0019] Exemplary diseases include, but are not limited to, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia, diabetes (e.g., type 2 diabetes), psoriasis, migraine, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergies. Exemplary types of drugs that can be included in the drug delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogs, protein variants, protein precursors, and / or protein derivatives. Exemplary drugs that may be included in the drug delivery devices described herein include etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), 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), darbecause Drug delivery devices described herein include, but are not limited to (and are not limited to) the examples of relevant disorders in parentheses: poietin alfa (anemia), belimumab (lupus), peginterferon beta-1a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycemia), epinephrine (anaphylaxis), insulin (diabetes), atropine, and vedolizumab (inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)). Pharmaceutical formulations comprising, but not limited to, any of the agents described herein, for example, a pharmaceutical formulation comprising an agent listed herein (or a pharmaceutically acceptable salt thereof) and a pharmaceutically acceptable carrier, are also contemplated for use in the drug delivery devices described herein.Pharmaceutical formulations containing the agents named herein (or pharmaceutically acceptable salts of the agents) may contain one or more other active ingredients, or may be the only active ingredient present.

[0020] Further exemplary disorders include dyslipidemia, cardiovascular disease, diabetes (e.g., type 1 diabetes 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 syndrome, atopic dermatitis, retinal disease (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infection, bone disease (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycemia, obesity, anaphylaxis, allergy, sickle cell disease, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IGE), and the like. These include, but are not limited to, IgE-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immune deficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, factor V Leiden), and cancer.

[0021] In a particularly simple embodiment, the drug delivery element and the piercing element are fixedly attached to the hub.

[0022] The puncturing element is typically a cannula, i.e., a hollow needle, also referred to as a needle for short. At least after puncturing the membrane, and in most embodiments even before, a fluid connection exists between the puncturing element and the drug delivery element. In a particularly simple and therefore preferred embodiment, the drug delivery element and the puncturing element are formed by a common needle having a proximal end forming part of the drug delivery element and a distal end forming part of the puncturing element. Thus, in this case, the drug delivery element and the puncturing element are jointly formed by a needle having an inner lumen extending continuously from the puncturing element to the drug delivery element. The needle is preferably made as a whole. In this case, puncturing the membrane opens the inner lumen of the needle, i.e., of the drug delivery element and the puncturing element, into the interior of the drug container, thereby allowing the drug to be expelled through the needle. However, other embodiments are also conceivable in which the puncturing element does not have an inner lumen but is instead formed by a spike element that functions, for example, to puncture the membrane, to establish a fluid connection between the interior of the drug container and the drug delivery element via a separate path, i.e., outside the spike element.

[0023] In its first position, the piercing element is positioned away from the membrane such that the membrane is intact and the interior of the medication container is sealed from the outside, and in the second position, the piercing element is displaced toward the membrane relative to the first position such that the piercing element extends through the membrane, i.e., the membrane is pierced by the piercing element.

[0024] The hub is a component of the subassembly that functions to displace the piercing element to pierce the membrane of the drug container. The hub is preferably fixedly attached to the piercing element. In a particularly preferred embodiment, the hub is fixedly attached to a needle that forms both the piercing element and the drug delivery element. However, embodiments are also envisaged in which the hub is not fixedly attached to the piercing element, but instead forms a separate part that can be moved independently relative to the piercing element, at least in certain states of the device. Manufacturing of the hub is particularly simple if the hub is formed as a single unit, advantageously by injection molding from a plastic material.

[0025] The cap preferably functions to cover the drug delivery element, or at least its proximal end, both radially and proximally to prevent the user from accidentally contacting the drug delivery element before and / or after injection. Furthermore, the cap may also function to keep the drug delivery element sterile before injection. The cap is preferably formed as a single piece, advantageously injection molded from a plastic material.

[0026] The first guide structure is preferably integrally molded on the hub. The second guide structure is preferably integrally molded on the cap. The first and second guide structures are designed so that rotation of the cap about its longitudinal axis results in displacement of the hub along the same longitudinal axis. The second guide structure of the cap may be formed, in particular, by a spiral groove, which is advantageously provided on the inner surface of the cap. Displacement of the hub displaces the piercing element from the first position to the second position. The mentioned longitudinal axis is preferably formed by a central main longitudinal axis of the cap, which advantageously coincides with the main longitudinal axis of the drug delivery device, extending from the proximal end to the distal end of the drug delivery device.

[0027] In a preferred embodiment, the cap is attached to the further component of the subassembly by a threaded or bayonet connection, and therefore removal of the cap preferably requires rotation about the longitudinal axis as defined by the threaded or bayonet connection.

[0028] In a particularly preferred embodiment, the subassembly further includes a guide nut having a first guide element engageable with a second guide element of the cap in such a manner that rotation of the cap about the longitudinal axis results in proximal displacement of the cap relative to the guide nut. Thus, with the preferred provision of first and second guide elements, rotational movement of the cap is superimposed with simultaneous proximal displacement.

[0029] The cap is preferably arranged radially inward of the guide nut. The guide nut is preferably fixedly attachable to the housing of the medication delivery device. Embodiments in which the guide nut is formed integrally with the housing are also envisaged. However, embodiments in which the guide nut forms a separate, independent part that can be attached to the housing directly or indirectly, i.e. via a further component, are preferred.

[0030] The first and second guide elements may be in the form of, for example, a screw thread. However, preferred embodiments are those in which the first guide element of the guide nut is in the form of an internal helical groove or in the form of a helical slot. The second guide element of the cap is therefore preferably in the form of one, two or more outwardly directed protrusions, which may be formed, for example, by noses, lugs or tabs, adapted to engage with the grooves or slots of the guide nut.

[0031] Rotation of the cap about the longitudinal axis preferably results in proximal displacement of the cap and distal displacement of the hub, which can be particularly achieved when the first or second guide structure is in the form of a helical groove or slot and the first or second guide element is also in the form of a helical groove, with the two helical grooves oriented in opposite directions.

[0032] The guide structure and the guide element are preferably designed so that the hub is displaced further distally than the cap in the proximal direction, thus ensuring optimal puncture of the membrane.

[0033] The first and second guide elements are preferably designed such that removal of the cap from the guide nut is only possible when the piercing element is in the second position, but not when the piercing element is in the first position, thereby ensuring that the membrane is pierced when the cap is removed and thus the drug delivery device is ready for injection.

[0034] The subassembly preferably further includes a retainer having guide slots engageable with guide lugs of the hub to guide displacement of the hub, in particular along the main longitudinal axis of the medication delivery device. The guide slots therefore preferably extend along the main longitudinal axis of the medication delivery device. In a preferred embodiment, the hub comprises two guide lugs, which are advantageously arranged at diametrically opposite positions on the hub. The retainer is preferably made entirely in one piece and is advantageously injection molded from a plastic material.

[0035] In a particularly preferred embodiment, one or more guide lugs not only function to guide the hub along the guide slots of the retainer, but also form a first guide structure for the hub. Therefore, the guide lugs in this case not only engage with the guide slots of the retainer, but also with the second guide structure of the cap. This can be easily and structurally simple in that the guide lugs extend through the guide slots of the retainer and further into the second guide structure of the cap.

[0036] The retainer preferably serves to fix the subassembly to the housing of the medication delivery device. Fixation of the retainer to the housing is preferably effected by a snap-fit ​​connection so as to facilitate assembly of the device. Advantageously, the retainer is provided with fastening hooks to enable particularly easy mounting of the retainer to the housing. Mounting of the retainer on the housing is preferably such that the retainer cannot rotate relative to the housing. The retainer preferably also serves to mount the guide nut and is provided with corresponding mounting means for this purpose. Mounting of the guide nut to the retainer is preferably effected by a snap-on connection. The guide nut and the retainer can also basically be formed integrally. To facilitate or even enable assembly of the device, it is preferred to design the guide nut and the retainer in the form of two separate parts.

[0037] The retainer preferably includes a circumferential seal to seal the retainer against the guide nut and / or cap when the subassembly is in its assembled state. The circumferential seal may, but need not, be integrally formed with the remainder of the retainer.

[0038] To lock the puncture element in the second position, the hub preferably includes a first snap element and the retainer includes a second snap element, which are adapted to engage with each other as soon as the puncture element assumes its second position. The first snap element of the hub is preferably in the form of one or two snap hooks, and the second snap element of the retainer is preferably in the form of one or two stop surfaces, particularly formed by apertures. Thus, the first and second snap elements lock the hub, and thus preferably the drug delivery element and the needle forming the puncture element, when the puncture element is in its second position. As a result, the user preferably cannot further remove the drug delivery element from the device, thereby significantly increasing the safety of the drug delivery device.

[0039] In a preferred embodiment, the hub is V-shaped in cross section, resulting in a longitudinal groove that opens to one side, which preferably serves to accommodate the needle therein, so that the needle can be particularly easily placed in the hub and subsequently bonded, i.e., glued, during the assembly process.

[0040] The subassembly can further include an outer cap attached to the cap via a latch mechanism that allows rotation of the outer cap in only one rotational direction relative to the cap about the longitudinal axis. The provision of the outer cap and the latch mechanism can effectively prevent erroneous operation of the subassembly by forcibly rotating the cap in the wrong rotational direction.

[0041] The present invention further provides a medication delivery device comprising a subassembly as shown.

[0042] Exemplary types of drugs or agents that may be included 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 therapy, radioisotopes and / or nuclear 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 therapy, cell or gene therapy, oncolytic viruses, or immunotherapy.

[0043] Exemplary drugs that may be included in the delivery devices described herein include, but are not limited to, immuno-oncology or biologic oncology drugs such as immune checkpoints, cytokines, chemokines, differentiation clusters, 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.

[0044] Exemplary drugs that can be included in the delivery devices described herein include modulators of the human epidermal growth factor receptor 2 (HER-2) receptor, 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 (B-CFR) modulators, and the like. 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 signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor AA, PDGFRA modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed 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 with Ig and ITIM domain (TIGIT) modulators, V-domain Ig suppressor of T cell activation activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LYG) modulators3, LAG3; also known as cluster of differentiation 223 or CD223) antagonist, cluster of differentiation 276 (CD276 or B7-H3) antigen modulator, cluster of differentiation 47 (CD47) antagonist, cluster of differentiation 30 (CD30) modulator, cluster of differentiation 73 (CD73) modulator, cluster of differentiation 66 (CD66) modulator, cluster of differentiation w137 (CDw137) agonist, cluster of differentiation 158 (CD158) modulator, cluster of differentiation 27 (CD27) modulator, cluster of differentiation 58 (CD58) modulator, cluster of differentiation 80 (CD80) modulator, cluster of differentiation 33 (CD33) modulator, cluster of differentiation 159 (CD159 or NKG2) modulator, glucocorticoid-induced TNFR-related (GITR) protein modulator, killer Ig-like receptor (KIR) receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway 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 cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily member 4 (TNF-α) modulators,These include, but are not limited to, drugs that exhibit a proposed mechanism of action, such as (TNFRSF4 or OX40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocyte (TIL) therapy, or T-cell receptor (TCR) therapy.

[0045] 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, pegylated interferon beta-1a, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dutasteride, thiazolinone ... These include, but are not limited to, pilumab, 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, ixekizumab, and immune globulin.

[0046] Exemplary drugs that may be included in the delivery devices described herein include 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, blepharoplastycin, blinatumomab, blinatumomab, blinatumab-drugs ... Oncology treatments may also include, but are not limited to, ntuximab 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.

[0047] Exemplary drugs that may be included in the delivery devices described herein include "generic" or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as being limited to each "originator" or "brand" version, such as, by way of non-limiting example, the originator drug adalimumab, and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0048] Exemplary drugs that may be included in the delivery devices described herein also include, but are not limited to, those used in adjuvant or preoperative chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Exemplary chemotherapy drugs include, by way of example only, 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.

[0049] Exemplary drugs that may be included in the delivery devices described herein also 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)), antithrombolytic agents, or diluents such as sterile water for injection (SWFI), 0.9% saline, 0.45% saline, 5% dextrose in water, 5% dextrose in 0.45% saline, lactated Ringer's solution, heparin lock flush solution, 100 U / mL heparin lock flush solution, or 5000 U / mL heparin lock flush solution.

[0050] Pharmaceutical formulations, including, but not limited to, any of the drugs described herein, such as pharmaceutical formulations comprising a drug listed herein (or a pharmaceutically acceptable salt thereof) and a pharmaceutically acceptable carrier, are also contemplated for use in the delivery devices described herein. Such formulations may contain one or more other active ingredients (e.g., in combination with one or more active drugs), or may be the only active ingredient, and may also include dispersion enhancers (e.g., animal-derived, human-derived, or recombinant hyaluronidase enzymes), concentration adjusters or enhancers, stabilizers, buffers, or other excipients, administered separately or co-formulated.

[0051] Exemplary drugs that may be included in the delivery devices described herein include AC, high-dose 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-intensive 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.

[0052] In general, all terms used in the claims should be interpreted according to their ordinary meaning in the art unless expressly defined otherwise herein. All references to elements, devices, members, components, means, etc. should be openly interpreted as referring to at least one instance of the element, device, member, component, means, etc. unless expressly stated otherwise. [Brief explanation of the drawings]

[0053] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings in which: [Figure 1] 1 is a perspective view of a subassembly of a medication delivery device according to a first embodiment of the present invention; FIG. [Figure 2] 2 shows the subassembly of FIG. 1 with the guide nut removed. [Figure 3] 3 shows the subassembly of FIG. 2 with the cap removed. [Figure 4] 2 shows an isolated hub with a needle of the subassembly of FIG. 1; [Figure 5] 2 shows the subassembly of FIG. 1 with the cap rotated and the needle in the puncture position, the cap being shown transparent for illustrative purposes. [Figure 6] 6 shows the subassembly of FIG. 5 with the cap removed. [Figure 7a] FIG. 2 is a central cross-sectional view through a guide nut of the subassembly of FIG. 1; [Figure 7b] 7b is a central cross-sectional view through the guide nut of the subassembly of FIG. 1 on the plane VIIb-VIIb shown in FIG. 7a; [Figure 8a] FIG. 2 is a central cross-sectional view through the cap of the subassembly of FIG. 1. [Figure 8b] 8b is a central cross-sectional view through the cap of the subassembly of FIG. 1 on the plane VIIIb-VIIIb shown in FIG. 8a; [Figure 9a] FIG. 2 is a central cross-sectional view through a retainer of the subassembly of FIG. 1. [Figure 9b] 9b is a central cross-sectional view through the retainer of the subassembly of FIG. 1 on the plane IXb-IXb shown in FIG. 9a; [Figure 10] 2 is a central cross-sectional view through the subassembly of FIG. 1, with the needle in a first position away from the membrane of the drug container. [Figure 11] 11 is the same cross-sectional view as FIG. 10, but with the cap rotated and the needle in a second position, piercing the membrane of the medication container. [Figure 12] Same cross section as in Figure 11, but with the cap removed. [Figure 13] FIG. 10 is a perspective view of a medication delivery device comprising a subassembly according to a second embodiment of the present invention. [Figure 14] 14 shows the drug delivery device of FIG. 13 with the outer cap removed. [Figure 15] 15 shows the drug delivery device of FIG. 14 with the cap removed. [Figure 16] 16 shows the drug delivery device of FIG. 15 with the housing removed. [Figure 17] 17 shows the drug delivery device of FIG. 16 with the cover sleeve and covering removed. [Figure 18] 18 shows the drug delivery device of FIG. 17 with the cover spring, rotor, and guide nut removed. [Figure 19] 19 shows the medication delivery device of FIG. 18 with the latch unit and cartridge holder removed. [Figure 20] 20 shows the drug delivery device of FIG. 19 with the retainer removed. [Figure 21a] FIG. 14 is a perspective view of the cap of the medication delivery device of FIG. [Figure 21b] FIG. 21b is a central cross-sectional view through the cap of FIG. 21a. [Figure 21c] 21b is a central cross-sectional view through the cap of FIG. 21a on the plane XXIc-XXIc shown in FIG. 21b. [Figure 22a] FIG. 10 is a partial side view of a hub having a needle of another variation of the subassembly of the present invention. [Figure 22b] 22b is the same partial side view of the hub and needle as FIG. 22a, but from a viewing angle perpendicular to that of FIG. 22a. [Figure 22c] FIG. 22b is the same partial perspective view of the hub and needle as FIG. 22a. [Figure 23a] 22b is a side view of another variation of a retainer adapted for use in combination with the hub and needle shown in FIG. 22a. [Figure 23b] FIG. 23b is a central cross-sectional view of the retainer of FIG. 23a. [Figure 23c]FIG. 23b is a perspective view of the retainer of FIG. 23a. [Figure 24] FIG. 10 is a perspective view of a subassembly of a medication delivery device according to a third embodiment of the present invention, without the guide nut and cap. [Figure 25a] 24b shows the isolated hub with needle of the subassembly of FIG. 24a as viewed from a first viewing direction. [Figure 25b] 24b shows the isolated hub with needle of the subassembly of FIG. 24a from a second viewing direction. [Figure 25c] FIG. 24b is a cross-sectional view of an isolated hub with needle of the subassembly of FIG. 24a. [Figure 26] FIG. 10 is a perspective view of a sub-assembly of a medication delivery device according to a fourth embodiment of the present invention. [Figure 27] FIG. 27 is an exploded perspective view of the subassembly shown in FIG. 26. [Figure 28] FIG. 27 is an exploded perspective view of the retainer of the subassembly shown in FIG. 26. [Figure 29] FIG. 27 is a cross-sectional view of the subassembly shown in FIG. 26. [Figure 30a] FIG. 27 is a cross-sectional view of the subassembly shown in FIG. 26 with the drug container. [Figure 30b] FIG. 27 is a cross-sectional view of the subassembly shown in FIG. 26 with the drug container. [Figure 31] FIG. 10 is a perspective view of a subassembly of a medication delivery device according to a fifth embodiment of the present invention. [Figure 32] FIG. 32 is an exploded perspective view of the subassembly shown in FIG. 31. [Figure 33a] FIG. 32 is a perspective view of the cap of the subassembly shown in FIG. 31. [Figure 33b] FIG. 32 is a perspective view of the cap of the subassembly shown in FIG. 31. [Figure 34] FIG. 32 is a cross-sectional view of the subassembly shown in FIG. 31. DETAILED DESCRIPTION OF THE INVENTION

[0054] The inventive concept will now be described in further detail with reference to the accompanying drawings, in which exemplary embodiments are shown. However, the inventive concept may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided as examples so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Elements, components, and portions of different examples, embodiments, or variations, but which have the same or similar functionality, are indicated by the same reference numerals in the figures.

[0055] 1 to 12 show a first embodiment of the present invention of a subassembly 2 of a medication delivery device in different views and states. The subassembly 2 includes a needle 21, a hub 22, a cap 23, a guide nut 24, and a retainer 25, as seen in FIGS.

[0056] The needle 21, which is made as a whole, includes a first proximal portion forming the drug delivery element 211 and a second distal portion forming the piercing element 212. The needle 21 has a continuous inner lumen that opens proximally at a pointed proximal end 2111 formed by the drug delivery element 211 and distally at a pointed distal end 2121 formed by the piercing element 212.

[0057] Needle 21 extends longitudinally through hub 22, as shown in Figure 4. Needle 21 is fixedly attached to hub 22, for example by a suitable adhesive, so that it cannot shift or rotate relative to hub 22.

[0058] The hub 22 is made as a whole in one piece from a plastic material, particularly by injection molding. The hub 22 includes two guide lugs 221 that project outward laterally on either side of the needle 21. The hub 22 further includes two flexible arms 222 that extend parallel to each other and in a proximal direction relative to the needle 21. Each flexible arm 222 is provided with a snap hook 223 that projects outward on either side of the needle 21 perpendicular to the guide lugs 221. Each of the snap hooks 223 forms a stop surface facing proximally.

[0059] The cap 23 is adapted to cover the needle 21 both radially and proximally to maintain the needle 21 in a sterile condition and reduce the risk of a user accidentally touching the needle 21 before an injection. To this end, the cap 23 includes a proximal top surface and a generally cylindrical side surface. A marker 231 is provided on the top surface to visualize the rotational state of the cap 23 in the figures. Therefore, the marker 231 is for illustrative purposes only. The inner surface of the cylindrical side surface of the cap 23 is provided with a guide track 232. The guide track 232 is formed by a helical groove extending longitudinally from the distal end to approximately the center of the cap 23. The longitudinal direction of the cap 23 is defined by a central major longitudinal axis 235 of the cap 23, and the central major longitudinal axis 230 also defines the central major longitudinal axis of the helical guide track 232. The distal end of the cap 23 is provided with two guide projections 233 which extend radially outward on either side of the cap 23. The cap 23 is made as a whole in one piece from a plastic material, preferably by injection molding.

[0060] The guide nut 24, shown alone in Figures 7a and 7b, has a generally hollow cylindrical design and is made in one piece from a plastic material, preferably by injection molding. Two rectangular apertures formed on either side of the distal region of the guide nut 24 are provided with latch hooks 241 in each case. The latch hooks 241 extend proximally and include, at their free ends, radially inward stop surfaces facing proximally in each case. The latch hooks 241 have a certain flexibility that allows them to flex slightly inward.

[0061] In the proximal region, the guide nut 24 has two helical guide slots 242 that extend on either side of the guide nut 24 over an angular region that is not entirely 180° in either case. The proximal ends of the guide slots 242 are located slightly away from the proximal end of the guide nut 24 and open into proximal longitudinal grooves 243. In the distal direction, the guide slots 242 extend to approximately the center of the guide nut 24, where their ends open into distal longitudinal grooves 244 in either case. The proximal and distal longitudinal grooves 243 and 244 are located on the inner surface of the guide nut 24 and extend longitudinally.

[0062] The retainer 25, shown alone in Figures 9a and 9b, has a central through-opening extending along the longitudinal direction. Two fastening hooks 251 extend diametrically opposite from a central cylindrical portion 250 of the retainer 25 in the distal direction. The fastening hooks 251 each include a radially outward stop surface at their free end, which faces proximally and serves to secure the retainer 25, and thus the subassembly 2, on the housing of the drug delivery device. A longitudinal web 252 is provided on the outer surface of each fastening hook 251. The longitudinal web 252, which extends a short distance distally, serves to prevent rotation of the retainer 25 relative to the housing when the drug delivery device is assembled. A proximal cylindrical portion extends proximally from the proximal end of the central cylindrical portion 250 of the retainer 25. The proximal cylindrical portion has a diameter significantly smaller than the central cylindrical portion 250 of the retainer 25 and is separated by a longitudinal guide slot 257 that runs along the entire longitudinal extension of the proximal cylindrical portion and extends laterally through the proximal cylindrical portion. The longitudinal guide slot 257 functions to guide the guide lug 221 of the hub 22. At its proximal end, the longitudinal guide slot 257 includes a constriction 258 that functions to latch the guide lug 221 in a proximal position on the hub 22 when the needle 21 is positioned away from the membrane 82 of the cartridge 8, i.e., when the membrane 82 is still intact (see, e.g., FIGS. 3, 9a, and 10, and the description below).

[0063] The proximal end region of the proximal cylindrical portion of retainer 25 is provided with two rectangular apertures 253 on diametrically opposite sides of retainer 25. By engagement with snap hooks 223, apertures 253 function to lock hub 22 in its distal position when membrane 82 of cartridge 8 is pierced by piercing element 212 (see, e.g., FIGS. 6 and 11 and the description below).

[0064] Retention protrusions 255 are provided on diametrically opposed sides of the proximal end of the central cylindrical portion of retainer 25 for fastening guide nut 24 to retainer 25. Retention protrusions 255 extend radially outward and include distally facing stop surfaces for retaining latch hooks 241 of guide nut 24, as shown, for example, in FIG. 10 . To prevent rotation of guide nut 24 relative to retainer 25, retainer 25 includes radially extending radial knobs 256 that are located in distally opening apertures in the sidewalls of guide nut 24 when guide nut 24 is fastened to retainer 25.

[0065] A circumferential seal 259 is provided at the proximal end of central cylindrical portion 250 of retainer 25 to seal retainer 25 against cap 23. Circumferential seal 259 includes a plurality of circumferential ribs and is preferably made of a softer material than the remainder of retainer 25. Circumferential seal 259 may be molded onto central cylindrical portion 250 in, for example, a two-component injection molding process.

[0066] To assemble the subassembly 2, in a first step, the hub 22 with the needle 21 is connected to the retainer 25 by engaging the guide protrusion 223 in the constriction 258 at the proximal end of the longitudinal guide slot 257 (see FIG. 10 ). In a second step, the cap 23 is moved distally toward the proximal cylindrical portion of the retainer 25. Once the guide track 232 engages the guide lug 221, the cap 23 is further moved toward the retainer 25 by a threading motion until its distal end is pressed onto the circumferential seal 259. In a further step, the guide nut 24 is moved distally toward the retainer 25 until the latch hook 241 engages with the retention protrusion 255. In doing so, the guide protrusion 233 of the cap 23 engages the distal longitudinal groove 244 of the guide nut 24 and ultimately the distal end of the guide slot 242. As a result, the subassembly 2 is in an assembled initial state as shown in Figures 1-3 and 10. In this initial state, the subassembly 2 can be transported and stored. The fastening hooks 251 allow the subassembly 2 to be fastened to the housing of a medication delivery device, which can be done before or after transportation and storage.

[0067] In use, the medical professional or user essentially simply unscrews the cap 23 to prepare the subassembly 2 for injection. In doing so, the guide protrusions 233 of the cap 23 are guided along the guide slots 242 of the guide nut 24, resulting in the cap 23 moving proximally relative to the guide nut 24. At the same time, the engagement of the guide lugs 221 of the hub 22 with the guide tracks 232 of the cap 23 causes the hub 22, along with the attached needle 21, to be displaced distally. During this displacement of the hub 22, the guide lugs 221 are guided by the longitudinal guide slots 257 of the retainer 25, which also prevents rotation of the hub 22 relative to the retainer 25. This distal displacement of the hub 22 causes the piercing element 212 to pierce the membrane 82 and establish fluid communication with the interior of the cartridge 8. The subassembly is in the state shown in FIG. 11 . After the cap 23 is fully rotated, the guide protrusion 233 engages the proximal longitudinal groove 243 of the guide nut 24, which allows the cap 23 to be removed from the guide nut 24 and the retainer 25. The subassembly 2 is thus ready for injection (FIG. 12).

[0068] Figure 13 shows a medication delivery device 1 including a subassembly according to an embodiment of the present invention. The medication delivery device 1, here shown in a state for transport and storage, includes a main longitudinal axis 13 extending from a proximal end 11 and a distal end 12. The subassembly 2 is attached to a cartridge holder 6 of the medication delivery device 1 (see Figure 17). For this purpose, the cartridge holder 6 includes, in the proximal region, rectangular openings 63 on diametrically opposite sides, which are adapted to be engaged by fastening hooks 251 of the retainer 25.

[0069] An outer cap 26 is attached onto the cap 23 of the subassembly 2, as shown in Figure 13. The cap 26 is engaged by an outer latch element 234 (Figures 14 and 21a) of the cap 23, and similar to a freewheel, the outer cap 26 rotates together with the cap 23 in one rotational direction but is freely rotatable relative to the cap 23 in the opposite rotational direction. Except for the design of the cap 23, the subassembly of the drug delivery device 1 shown in Figures 13 to 21c is identical to, or at least similar to, that of Figures 1 to 12.

[0070] As can be seen in Figures 13 to 15, the medication delivery device 1 includes a cylindrical outer housing 3. The housing 3 includes windows 31 on diametrically opposite sides to allow a user to view the fill level of the medication container, i.e., cartridge 8.

[0071] As shown in FIG. 16 , a cover unit 4 is provided inside the housing 3. The cover unit 4 functions to radially cover the needle 21 to prevent the user from accidentally touching the drug delivery element 211 before and after injection. To this end, the cover unit 4 includes a cover sleeve 41, a cover ring 42, and a cover spring 43. The cover spring 43 applies a proximal force to the cover sleeve 41 and the cover ring 42 attached to the proximal end of the cover sleeve 41. As a result, the cover sleeve 41 and the cover ring 42 are in a proximal position where they radially cover the drug delivery element 211 before and after injection. For injection, the drug delivery device 1 is pressed against the user's body at its proximal end 11, causing the cover sleeve 41 and the cover ring 42 to retract against the force exerted by the cover spring 43, as shown in FIG. 16 . Retraction of the cover unit 4 exposes the drug delivery element 211, ready for injection. The cover sleeve 41 has a window 413 to allow the user to see the fill level of the cartridge 8 through the window 31 in the housing 3 .

[0072] 17, a rotor 5 is provided at the distal end of the medication delivery device 1, radially inward of the cover sleeve 41. The rotor 5 has a guide track 51 on its radially outer side, which engages with a guide protrusion 412 on the inside of the cover sleeve 41. Due to the engagement of the guide track 51 with the guide protrusion 412, the cover sleeve 41 is locked in its longitudinal position after it has been retracted distally relative to the housing 3 and then extended proximally, i.e., after the injection is completed and the device is removed from the patient's body.

[0073] Proximal to the rotor 5 is located the cartridge holder 6 (Figures 17 and 18). The cylindrical cartridge holder 6, which forms an interior space for accommodating the cartridge 8, is rotationally and radially centered by longitudinal ribs 61 that form a longitudinal recess on the exterior of the cartridge holder 6 and a longitudinal ridge on the interior. Toward the interior, the longitudinal ribs 61 serve to radially center the cartridge 8, and to the exterior, the longitudinal ribs 61 mate with respective longitudinal ribs 411 of the cover sleeve 41 to prevent rotation of the cartridge holder relative to the cover sleeve 41.

[0074] The cartridge holder 6 includes a stop element 62 that protrudes radially outward through a longitudinal aperture 414 in the cover sleeve 41 (see FIG. 16 ) and through an aperture 32 in the housing 3 (see FIG. 15 ). Due to the engagement of the stop element 62 with the aperture 32 in the housing 3, the cartridge holder 6 is fixed to the housing 3 in such a manner that it cannot rotate or be displaced relative to the housing 3. The engagement of the stop element 62 with the longitudinal aperture 414 of the cover sleeve 41 provides a longitudinal guide of the cover sleeve 41 relative to the cartridge holder 6 in such a manner that the cover sleeve 41 cannot rotate relative to the cartridge holder 6.

[0075] The cartridge holder 6 has longitudinally proximally opening slits 64 on diametrically opposite sides of its proximal end that mate with longitudinal webs 252 to prevent rotation of the retainer 25 relative to the cartridge holder 6. Retaining elements 65 in the form of radially inwardly projecting latch hooks function to distally retain the cartridge 8 inside the cartridge holder 6.

[0076] Disposed within cartridge holder 6 is cartridge 8, which typically has a generally elongated cylindrical shape with a neck and a proximal cartridge head 81, as shown in Figures 19 and 20. The proximal surface of cartridge head 81 forms an opening that is sealed by membrane 82. For injection, membrane 82 is pierced by needle 21, as shown in Figure 20.

[0077] The actual injection is triggered by retraction of the cover sleeve 41, which releases the injection unit 9, which in turn advances the plunger into the cartridge 8 by the injection spring 91 (see Figures 19 and 20). Forward movement of the plunger expels medicament from the interior of the cartridge 8, through the needle 21, and into the patient's body. The injection spring 91 is guided longitudinally by a spring guide 92 that extends longitudinally from its distal end into the injection spring. The release of the injection unit 9 by the cover sleeve 41 is based on mechanisms well known to those skilled in the art.

[0078] A cylindrical latch sleeve 7 is disposed radially inward of the rotor 5 and cartridge holder 6, but outside the injection spring 91. The latch sleeve 7 has a longitudinally extending latch rail 71 on its outer surface, as seen in FIG. 18. The latch sleeve 7 functions to adjust the distance between its distal and proximal ends, and thus the pretension of the injection spring 91 when the injection spring 91 is in a pretensioned, i.e., compressed, state. This is achieved by the latch nose 66 of the cartridge holder 6 engaging with the latch rail 71. Diametrically opposite the distal end of the latch sleeve 7, radially outwardly extending protrusions 72 engage with respective recesses on the outside of the rotor 5 to limit the rotor's rotational movement.

[0079] 22a-22c show a variant of the hub 22 with the needle 21 according to another, also inventive, embodiment of the subassembly 2. The hub 22 shown in FIGS. 22a-22c is adapted to interact with a variant of the retainer 25 shown in FIGS. 23a-23c. In contrast to the previous embodiment, one of FIGS. 22a-22c includes a hub 22 that does not have a flexible arm 222 with a snap hook 223. Instead, the hub 22 here includes a guide lug 221 with a snap notch 224. The snap notch 224 is adapted to be engaged by a retaining hook 254 provided in a longitudinal guide slot 257 of the retainer 25 to lock the hub 22 in its distal position after puncturing the membrane 8. The retainer 25 thus differs from one of the previous embodiments by having a retaining hook 254 instead of an aperture 253.

[0080] FIG. 24 illustrates a needle 21 mounted on a hub 22 held by a retainer 25 in a subassembly according to another embodiment of the present invention. The embodiment of FIG. 24 differs from the embodiment of FIGS. 1-23c particularly by the design of the hub 22. As seen in FIGS. 25a and 25b, and particularly in FIG. 25c, the hub 22 is V-shaped in cross section, thereby forming a longitudinal groove that opens toward one side. During assembly, the longitudinal groove allows the needle 21 to be particularly easily positioned on the hub 22 and subsequently bonded, i.e., glued. Furthermore, the hub 22 of the embodiment of FIGS. 24-25c has the advantage of being suitable for carrying needles 21 of different diameters. In contrast, the hub designs of, for example, FIGS. 4 and 22a-22c require a dedicated hub 22 for each diameter of needle 21 to maintain adequate clearance for adhesive entry and not allow too much play to prevent excessive tilting of the needle shaft relative to the retainer shaft. Also, in the embodiments of Figures 24-25c, "side loading" allows attachment of needle 21 to hub 22 without the need for mechanical contact with either proximal end 2111 or distal end 2121 of needle 21. Inserting needle 21 into the through-hole, as is done in the embodiments of Figures 4 and 22a-22c, requires some sort of mechanical stop, which means that one of ends 2111 and 2121 must be contacted, potentially resulting in some deformation, which may affect puncture performance.

[0081] 26 to 30b show a variation of the medication delivery device 1 in which the retainer 22 has been modified. In most respects, the embodiment shown in FIGS. 26 to 30b is identical to the embodiment shown in FIGS. 1 to 12. However, in the embodiment shown in FIGS. 26 to 30b, the retainer 25 comprises an interface 280 and an adapter 281. Furthermore, the retainer 25 not only receives the medication container 8 at the distal end of the subassembly 2, but also functions to secure the medication container 8 to the subassembly 2. This avoids the need for additional securing means elsewhere on the medication delivery device 1 to secure the medication container 8 in place.

[0082] More specifically, the retainer 25 of the embodiment shown in FIGS. 26-30b includes a port 260 for receiving the head 81 of the medicament container 8. The inner wall of the port 260 is provided with two protrusions 261. The protrusions 261 are integrally formed with the retainer 25. When the head 81 of the medicament container 8 is received within the port 260, the protrusions 261 are deflected to provide a biasing force that urges the head 81 proximally and secures the head 81 within the port 260. Specifically, as can be seen most clearly in FIG. 30b, the protrusions 261 grip the distally facing surface of the head 81 of the medicament container 8. The protrusions 261 extend radially inward and are angled proximally so as to be snap-fit ​​into the position shown in FIG. 30b. The protrusions 261 are tapered radially inward. This helps to locate the protrusions 261 in their position between the head 81 of the medicament container 8 and the shoulder of the body of the medicament container 8 .

[0083] In the illustrated embodiment, two protrusions 261 are provided. However, in other embodiments, there may be other numbers of protrusions 261, for example, two or more. Typically, the protrusions 261 are equally spaced circumferentially.

[0084] One or more distal-facing surfaces 284 are provided for engaging the head 81 of the medication carrier 8. The protrusions 261 and distal-facing surfaces 284 are arranged such that the head 81 is retained between the one or more distal-facing surfaces 284 and the protrusions 261. In the illustrated embodiment, each of the distal-facing surfaces 284 is a surface of a tab extending radially inward from the wall of the retainer 25. It can also be seen that the protrusions 261 and the distal-facing surfaces 284 are circumferentially offset from one another. In other embodiments, the distal-facing surfaces 284 may be annular.

[0085] Retainer 25 comprises an interface 280 and an adapter 281. Port 260 and protrusion 261 are provided on adapter 281, which is attachable to interface 280. Distal-facing surfaces 284 are provided on interface 280, although in other embodiments, they may be provided on adapter 281. This means that different sizes and shapes of drug containers 8 can be accommodated using different adapters 281, but interface 280 and other components of the subassembly may be common to a variety of different sizes and shapes of drug containers 8. This reduces manufacturing costs and simplifies assembly.

[0086] In the illustrated embodiment, the adapter 281 snaps into the interface 280. More specifically, the adapter 281 has mounting protrusions 282, and the interface 280 has mounting recesses 283. The mounting protrusions 282 and the mounting recesses 283 cooperate to secure the adapter 281 to the interface 280. Specifically, the mounting protrusions 282 and the mounting recesses 283 snap into one another. In the illustrated embodiment, four mounting protrusions 282 and four mounting recesses 283 are provided, although a different number of mounting protrusions 282 and mounting recesses 283 may be utilized in other embodiments. In still other embodiments, the mounting protrusions 282 may be provided on the interface 280 and the mounting recesses 281 may be provided on the adapter 281, or other fasteners may be provided to attach the adapter 281 to the interface 280.

[0087] Figures 31 to 34 show variations of the medication delivery device 1 in which the operation of the subassemblies is modified. In most respects, the embodiment shown in Figures 31 to 34 is identical to the embodiment shown in Figures 1 to 12. However, in the embodiment shown in Figures 31 to 31, the cap 23 is adapted to be displaced axially in the proximal direction to cause the piercing element 212 to pierce the membrane 82 of the medication container, but not rotate.

[0088] More specifically, guide nut 24 is disposed between hub 22 and cap 23. Hub 22 has first guide structure 221, and cap 23 has second guide structure 232. First guide structure 221 and second guide structure 232 are adapted to engage guide nut 24 in a manner such that axial displacement of cap 23 proximally along longitudinal axis 235 rotates guide nut 24, thereby displacing hub 22 distally along longitudinal axis 235 and displacing puncturing element 212 from a first position to a second position.

[0089] The retainer 25 has a guide slot 257 that is engageable with the first guide structure 221 of the hub 22 and guides the displacement of the hub 22. The guide nut 24 is mounted on the retainer 25 so as to be rotatable about the longitudinal axis 235.

[0090] The first guide structure 221 on the hub 22 includes two lugs, and the guide nut 24 has one or more inward spiral grooves 322, each cooperating with one of the lugs. The second guide structure 232 on the cap 23 is one or more radially inward spiral grooves, and the guide nut 24 has one or more radially outward lugs 323 for cooperating with one of the radially inward spiral grooves of the cap 23. The one or more inward spiral grooves 322 of the guide nut 24 are oriented opposite to the one or more inward spiral grooves of the cap 23. That is, one may proceed, for example, clockwise in the proximal direction, while the other may extend counterclockwise in that direction. In other embodiments, a different number of lugs and spiral grooves may be provided, for example, one or more lugs and spiral grooves. It will be understood that in other embodiments, the lugs may be replaced with slots and the grooves with threads to achieve substantially the same effect.

[0091] As cap 23 is displaced proximally along longitudinal axis 235, lugs on guide nut 24 are urged circumferentially by the helical grooves in cap 23, causing guide nut 24 to rotate. Cap 23 is prevented from rotating by the presence of ribs 320 on its outer surface that cooperate with grooves 321 in cover unit 42, and cover unit 42 itself is secured against rotation elsewhere. Guide nut 24 is also prevented from axial displacement by retainer 25, e.g., by proximally and distally facing retention surfaces on retainer 25 that cooperate with guide nut 24. As guide nut 24 rotates, lugs on hub 22 move within the helical grooves in guide nut 24, causing hub 22 to displace distally along longitudinal axis 235 from a first position to a second position.

[0092] The cap 23 has a knob 310 at its proximal end to facilitate a user's gripping the cap 23 and applying a force that causes axial displacement of the cap 23 .

[0093] The inventive concept has been described primarily with reference to a few examples. However, as will be readily apparent to those skilled in the art, other embodiments than those disclosed above are equally possible within the scope of the inventive concept as defined by the appended claims. In particular, it should be noted that the combinations of elements, components, and parts shown in the figures should be understood as non-limiting examples only. Individual elements, components, and parts of the various embodiments described and / or shown in the figures can essentially be interchanged with one another as desired, and can be supplemented, for example, with additional elements.

Claims

1. A subassembly (2) of a drug delivery device (1) for delivering a drug from a drug container (8) to a human or animal patient, comprising: a drug delivery element (211) having a proximal end (2111) through which the drug can be delivered to the patient; a piercing element (212) for piercing the membrane (82) of the drug container (8) to fluidly connect the drug delivery element (211) to the drug container (8); a hub (22) adapted to displace the piercing element (212) from a first position in which the piercing element (212) is positioned away from the membrane (82) of the drug container (8) to a second position in which the membrane (82) is pierced by the piercing element (212); a cap (23) for covering the proximal end (2111) of the drug delivery element (211) before use of the drug delivery device (1); The hub (22) has a first guide structure (221) and the cap (23) has a second guide structure (232), the first guide structure (221) and the second guide structure (232) adapted to engage with each other in such a manner that rotation of the cap (23) about a longitudinal axis (235) results in displacement of the hub (22) along the longitudinal axis (235) and displacement of the puncture element (212) from the first position to the second position.

2. 2. The subassembly (2) of claim 1, further comprising a guide nut (24) having a first guide element (242) engageable with a second guide element (232) of the cap (23) in a manner such that rotation of the cap (23) about the longitudinal axis (235) results in proximal displacement of the cap (23) relative to the guide nut (24).

3. 3. The subassembly (2) of claim 1 or 2, wherein rotation of the cap (23) about the longitudinal axis (235) results in displacement of the cap (23) in a proximal direction and displacement of the hub (22) in a distal direction.

4. 4. The subassembly (2) of claim 3, wherein the hub (22) is displaced further distally than the cap (23) in the proximal direction.

5. The subassembly (2) according to any one of claims 2 to 4, wherein the first guide element (242) and the second guide element (232) are designed such that removal of the cap (23) from the guide nut (24) is possible only when the piercing element (212) is in the second position, and is not possible when the piercing element (212) is in the first position.

6. The subassembly (2) of any one of claims 1 to 5, further comprising a retainer (25) having guide slots (257) engageable with guide lugs (221) of the hub (22) to guide displacement of the hub (22).

7. 7. The subassembly (2) of claim 6, wherein the hub (22) comprises a first snap element (223; 224) and the retainer (25) comprises a second snap element (253; 254), which are adapted to engage with each other to lock the puncture element (212) in the second position.

8. The subassembly (2) according to claim 6 or 7, wherein the retainer (25) serves to secure the subassembly (2) to the housing (3) of the medication delivery device (1) by means of a snap-on connection.

9. 9. The subassembly (2) of any one of claims 1 to 8, further comprising an outer cap (26), the outer cap (26) being attached to the cap (23) via a latch mechanism, the latch mechanism allowing the outer cap (26) to rotate relative to the cap (23) about the longitudinal axis (235) in only one rotational direction.

10. A subassembly (2) according to any one of claims 1 to 9, wherein the drug delivery element (211) and the piercing element (212) are fixedly attached to the hub (22), which is preferably made entirely in one piece.

11. The subassembly (2) according to any one of claims 1 to 10, wherein the second guide structure (232) of the cap (23) is formed by a spiral groove.

12. A drug delivery device (1) comprising a subassembly (2) according to any one of claims 1 to 11.

13. A subassembly (2) of a drug delivery device (1) for delivering a drug from a drug container (8) to a human or animal patient, comprising: a drug delivery element (211) having a proximal end (2111) through which the drug can be delivered to the patient; a piercing element (212) for piercing the membrane (82) of the drug container (8) to fluidly connect the drug delivery element (211) to the drug container (8); a hub (22) adapted to displace the piercing element (212) from a first position in which the piercing element (212) is positioned away from the membrane (82) of the drug container (8) to a second position in which the membrane (82) is pierced by the piercing element (212); a cap (23) for covering the proximal end (2111) of the drug delivery element (211) before use of the drug delivery device (1); a retainer (25) configured to receive the drug container (8) at a distal end of the subassembly (2), the retainer (25) including a port (260) for receiving a head (81) of the drug container (8) and one or more protrusions (261) that are deflected when the head (81) is received in the port (260) to urge the head (81) in a proximal direction and provide a biasing force that secures the head (81) to the port (260).

14. 15. The subassembly (2) of claim 14, wherein there are a plurality of protrusions (261), said protrusions (261) being equally spaced circumferentially.

15. 15. The subassembly (2) of claim 13 or claim 14, wherein the protrusions (261) extend radially inward and are angled proximally.

16. A subassembly (2) according to any one of claims 13 to 15, wherein the protrusions (261) are tapered radially inward.

17. The subassembly (2) according to any one of claims 13 to 16, wherein the protrusion (261) is integrally formed with the retainer (25).

18. A subassembly (2) according to any one of claims 13 to 17, further comprising one or more distally facing surfaces (284) for engaging with the head (81) of the medication carrier (8), whereby the head (81) is held between the one or more distally facing surfaces (284) and the protrusion (261).

19. 19. The subassembly (2) of claim 18, wherein each of the distally facing surfaces (284) is a surface of a tab extending radially inward from a wall of the retainer (25).

20. The subassembly (2) of any one of claims 13 to 19, wherein the retainer (25) comprises an interface (280) and an adapter (281), the port (260) and the protrusion (261) are provided on the adapter (281), and the adapter (281) is attachable to the interface (280).

21. 21. The subassembly (2) of claim 20, wherein the adapter (281) is a snap fit to the interface (280).

22. 21. The subassembly (2) of claim 20, wherein one of the interface (280) and the adapter (281) has a mounting protrusion (282) and the other of the interface (280) and the adapter (281) has a mounting recess (283), the mounting protrusion (282) and the mounting recess (283) cooperating with each other to secure the adapter (281) to the interface (280).

23. 23. The subassembly (2) of claim 22, wherein one of the interface (280) and the adapter (281) has two or more mounting protrusions (282), and the other of the interface (280) and the adapter (281) has two or more mounting recesses (283), the mounting protrusions (282) and the mounting recesses (283) cooperating with each other to secure the adapter (281) to the interface (280).

24. 24. The subassembly (2) according to claim 22 or 23, wherein the mounting projection (282) and the mounting recess (283) are snap-fit ​​together.

25. A subassembly (2) of a drug delivery device (1) for delivering a drug from a drug container (8) to a human or animal patient, comprising: a drug delivery element (211) having a proximal end (2111) through which the drug can be delivered to the patient; a piercing element (212) for piercing the membrane (82) of the drug container (8) to fluidly connect the drug delivery element (211) to the drug container (8); a hub (22) adapted to displace the piercing element (212) from a first position in which the piercing element (212) is positioned away from the membrane (82) of the drug container (8) to a second position in which the membrane (82) is pierced by the piercing element (212); a cap (23) for covering the proximal end (2111) of the drug delivery element (211) before use of the drug delivery device (1); a guide nut (24) disposed between the hub (22) and the cap (23); The hub (22) has a first guide structure (221) and the cap (23) has a second guide structure (232), the first guide structure (221) and the second guide structure (232) adapted to engage with the guide nut (24) in a manner such that axial displacement of the cap (23) in a proximal direction along a longitudinal axis (235) results in rotation of the guide nut (24), thereby causing displacement of the hub (22) in a distal direction along the longitudinal axis (235) and displacement of the puncture element (212) from the first position to the second position.

26. 26. The subassembly (2) of claim 25, further comprising a retainer (25) having a guide slot (257) engageable with the first guide structure (221) of the hub (22) and guiding the displacement of the hub (22).

27. 27. The subassembly (2) of claim 26, wherein the guide nut (24) is mounted to the retainer (25) for rotation about the longitudinal axis (235).

28. The subassembly (2) according to any one of claims 25 to 27, wherein the first guide structure (221) is one or more lugs.

29. 29. The subassembly (2) of claim 28, wherein the guide nut (24) has one or more inward spiral grooves (322), each inward spiral groove (322) cooperating with one of the one or more lugs.

30. A subassembly (2) according to any one of claims 25 to 29, wherein the second guide (232) structure is one or more radially inward spiral grooves.

31. 31. The subassembly of claim 30, wherein the guide nut (24) has one or more radially outwardly extending lugs (323), each of the lugs cooperating with one of the one or more radially inwardly extending spiral grooves.

32. 32. The subassembly (2) of any one of claims 25 to 31, wherein one of the cap (23) and another component of the subassembly (2) has one or more ribs (320) and the other of the cap (23) and another component of the subassembly (2) has one or more grooves (321), the one or more ribs (320) and the one or more grooves (321) cooperating with each other to prevent rotation of the cap (23) about the longitudinal axis (252) while allowing the axial displacement of the cap (23).

33. 33. The subassembly (2) according to claim 32, wherein another component of the subassembly is a cover unit (42) for covering the drug delivery element (211).

34. The subassembly (2) of any one of claims 25 to 33, wherein the cap (23) has a knob (310) at a proximal end to facilitate a user gripping the cap (23) and applying a force that causes the axial displacement of the cap (23).

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