EP4676570A1

EP4676570A1 - A subassembly of a medicament delivery device

Info

Publication number: EP4676570A1
Application number: EP24708867.7A
Authority: EP
Inventors: Stephan Müller; René ZANDER; Felix NAEGELI
Original assignee: SHL Medical AG
Current assignee: SHL Medical AG
Priority date: 2023-03-08
Filing date: 2024-03-08
Publication date: 2026-01-14
Also published as: JP2026507216A; CN120916803A; TW202500207A; KR20250155614A; TW202533845A; MX2025010329A; WO2024184513A1; TWI886829B; AU2024232758A1

Abstract

A subassembly (2) of a medicament delivery device (1) comprises a hub (22), which is adapted to displace a piercing element (212) from a first position distant from a membrane (82) of a medicament container (8) to a second position, in which the membrane (82) is pierced by the piercing element (212), such that the medicament container (2) is fluidly connected to a medicament 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 medicament delivery element (211) are adapted to engage with each other in such a way that a rotation of the cap (23) about a longitudinal axis (235) results in a displacement of the hub (22) along the longitudinal axis (235) and of the piercing element (212) from the first position to the second position.

Description

A SUBASSEMBLY OF A MEDICAMENT DELIVERY DEVICE

TECHNICAL FIELD

The present invention generally relates to medicament delivery devices, such as cartridge injection devices, and particularly concerns a subassembly of such a medicament delivery device.

BACKGROUND

Cartridge injection devices, for example cartridge auto-injectors, typically have a sealed medicament container, which forms a cartridge and contains a medicament. The device usually further comprises a needle that is initially separated from the medicament container. Before use of the injector device, the medicament container is pierced by a piercing portion of the needle, in order to establish a fluid connection between the medicament container and a medicament delivery portion of the needle. A plunger can then be moved into the medicament container, in order to dispense medicament through the needle for injection to a user.

A particular challenge relates to the development of medicament delivery devices that are not only easy to handle for the user, but that are also particularly safe. Especially for inexperienced patients or for patients who require frequent injections, there is the problem that incorrect handling or a malfunction of the device can lead, for example, to an incorrect dosage of the injected medicament, a defect in the device or even an injury. In this context, the medicament delivery element in particular, i.e. the needle through which the medicament is injected subcutaneously, poses a risk of patient injury. In cartridge injection devices, it is therefore desirable to achieve the necessary piercing of the cartridge by the needle in a manner that is as safe and simple as possible for the user.

In this context, WO 2013/089616 Al discloses a device with a cap for covering a needle attached to a hub. When screwing off the cap, the hub is rotated with the cap and thereby screwed into an opposite inner thread, causing the needle to approach the cartridge and eventually pierce it. Similar mechanisms are disclosed by WO 2020/120087 Al, WO 2021/148176 Al, WO 2014/076225 Al and WO 2009/150078 Ai. Mechanisms with opposite threads as disclosed by these documents often have the disadvantage that after removing the cap, the needle can be removed from the device by rotating the hub in the counter direction.

Further cartridge injection devices with a mechanism for piercing the cartridge by means of a needle are for example disclosed in WO 2022/106121 Al and WO 2019/106202 Al.

US 2020/0368436 Ai discloses an injector device with a housing that has a guide slot for guiding a slot engagement portion of a needle unit that carries the needle. For piercing the membrane of the cartridge by means of the needle, the needle unit needs to be rotated relative to the housing and along the guide slot. Thus, in order to use the injector, a further step in addition to the removal of the cap is required.

US 2018/0344934 Ai discloses a device with a cartridge holder having a guide pin that engages with a guide groove provided on a tubular member of an end cap. When rotating the end cap for removing it from the device, a needle holder is pressed onto the cartridge by the tubular member due to the guidance of the guide pin in the guide groove. Consequently, a membrane of the cartridge is pierced by the needle before the cap can be removed. Since the cap first needs to be moved further onto the device before it can be removed from it, the mechanism has disadvantages in terms of intuitiveness for the user. The design as proposed by this document also requires complex components and a complicated assembly process.

SUMMARY

It is an object of the present invention to provide a subassembly of a medicament delivery device, which is not only safe to use, but also particularly intuitive and easy to handle. In addition, the subassembly should preferably be simple to manufacture. This object is solved by a subassembly as claimed in claim 1. Further embodiments of the subassembly are provided in the dependent claims. A medicament delivery device comprising such a subassembly is indicated in claim 12.

The present invention thus provides a subassembly of a medicament delivery device for delivering a medicament from a medicament container to a human or animal patient, wherein the subassembly comprises:

- a medicament delivery element with a proximal end, through which the medicament can be delivered to the patient; - a piercing element for piercing a membrane of the medicament container in order to fluidly connect the medicament delivery element to the medicament container;

- a hub, which is adapted to displace the piercing element from a first position, in which the piercing element is arranged distant from the membrane of the medicament container, to a second position, in which the membrane is pierced by the piercing element; and

- a cap for covering the proximal end of the medicament delivery element prior to the use of the medicament delivery device.

The hub has a first guide structure and the cap has a second guide structure. The first guide structure and the second guide structure are adapted to engage with each other in such a way that a rotation of the cap about a longitudinal axis results in a displacement of the hub along the longitudinal axis and of the piercing element from the first position to the second position.

By providing the cap with a guide structure for displacing the hub, it is possible to translate the movement for removing the cap directly into a displacing of the hub and, thus, into a piercing of the membrane by means of the piercing element. Thus, no intermediate part is required, in order to transmit the removal movement of the cap to the displacement of the hub. Since the cap directly drives the hub, the transmission of the movement is particularly effective. As a result, the required force by the user for removing the cap from the device and at the same time piercing the membrane can be kept minimal. Furthermore, a desired movement transmission behaviour can be achieved by designing the first and second guide structures accordingly. For example, the guide structures can be designed such that an unscrewing movement of the cap along the proximal direction is translated into a displacement of the hub in the distal direction, which results in a particularly intuitive and easy handling of the device for the user. Since not intermediate parts are required for the motion transmission, the subassembly can also be manufactured with a minimum number or components and, thus, in a particularly simple manner. In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the medicament delivery device is/are located furthest away from the dose or medicament delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the medicament delivery device is/are located closest to the dose delivery site.

Further, unless otherwise indicated, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer, to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and/or component.

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

The medicament delivery device is preferably a cartridge injection device. Thus, the medicament container, which comprises a membrane, can typically be removed from the rest of the medicament delivery device, in particular from the housing, e.g. after delivery of the medicament, in order to be replaced by another filled medicament container, which is used for a subsequent injection. The membrane serves to seal the interior of the medicament container, in which the medicament is stored, towards the outside. For enabling an injection of the medicament to the patient, the membrane is pierced by the piercing element usually immediately prior to the injection.

The medicament delivery device can for example be an autoinjector, a pen injector or an on-body device. The medicament delivery element is usually a cannula or hollow needle, also abbreviated as a needle. The medicament delivery device is preferably adapted to be inserted into the skin of the patient with its proximal end first, in order to subcutaneously inject the medicament to the desired place inside of the patient's body. The medicament is usually delivered from the medicament container to the patient, by means of forwarding a plunger inside of the container in the proximal direction. The forwarding of the plunger can be effected manually, motor-driven, or, what is preferred here, by means of a spring, in particular a spiral spring.

The medicament delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies. Exemplary types of medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, and/or protein derivatives. Exemplary medicaments that could be included in the medicaments delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-ia (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-ia' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)). Pharmaceutical formulations including, but not limited to, any medicament described herein are also contemplated for use in the medicament delivery devices described herein, for example pharmaceutical formulations comprising a medicament as listed herein (or a pharmaceutically acceptable salt of the medicament) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising a medicament as listed herein (or a pharmaceutically acceptable salt of the medicament) may include one or more other active ingredients, or may be the only active ingredient present.

Further exemplary disorders include, but are not limited to: dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hi dradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behget's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, 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 immunodeficiency, 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.

In an embodiment that is particularly simple in construction, the medicament delivery element and the piercing element are fixedly attached to the hub.

The piercing element is usually a cannula or hollow needle, also abbreviated as a needle. At least after piercing the membrane, in most embodiments also before, a fluid connection is present between the piercing element and the medicament delivery element. In a particularly simple to manufacture and therefore preferred embodiment, the medicament delivery element and the piercing element are formed by a common needle, which has a proximal end, that forms a part of the medicament delivery element, and a distal end, that forms a part of the piercing element. Thus, the medicament delivery element and the piercing element are in this case together formed by a needle having an inner lumen that runs continuously from the piercing element to the medicament delivery element. The needle is preferably made as a whole in one piece. In this case, by piercing the membrane, the inner lumen of the needle, i.e. of the medicament delivery element and the piercing element, opens into the interior of the medicament container, which allows the medicament to be expelled through the needle. Other embodiments are also conceivable, however, in which the piercing element does not have an inner lumen, but instead is formed by e.g. a spike element that serves to pierce the membrane, in order to establish a fluid connection between the interior of the medicament container and the medicament delivery element via a separate pathway, i.e. outside of the spike element.

In its first position, the piercing element is arranged distant from the membrane, such that the membrane is intact and the interior of the medicament container is sealed towards the outside. In the second position, the piercing element has been displaced, with regard to the first position, towards the membrane, such that it extends through the membrane, i.e. the membrane is pierced by the piercing element.

The hub is a component of the subassembly that serves to displace the piercing element, in order to pierce the membrane of the medicament container. The hub is preferably fixedly attached to the piercing element. In a particularly preferred embodiment, the hub is fixedly attached to a needle, which forms both the piercing element and the medicament delivery element. Embodiments are, however, also conceivable, in which the hub is not fixedly attached to the piercing element, but instead forms a separate part that can be moved independently to the piercing element at least in certain states of the device. Manufacturing of the hub is particularly simple, if it is made as a whole in one piece and advantageously injection moulded from a plastics material.

The cap preferably serves to cover the medicament delivery element or at least its proximal end both radially and proximally, in order to prevent the user from accidentally contacting the medicament delivery element before and/or after injection. In addition, the cap can also serve to keep the medicament delivery element in a sterile condition before injection. The cap is preferable made as a whole in one piece and advantageously injection moulded from a plastics material.

The first guide structure is preferably integrally moulded onto the hub. The second guide structure is preferably integrally moulded onto the cap. The first and the second guide structures are designed such that due to the guide structures, a rotation of the cap about a longitudinal axis effects a displacement of the hub along the same longitudinal axis. The second guide structure of the cap can particularly be formed by a helical groove, which is advantageously provided on the inner surface of the cap. Because of the displacement of the hub, the piercing element is displaced from the first to the second position. The longitudinal axis as mentioned is preferably formed by the central main longitudinal axis of the cap, which advantageously coincides with the longitudinal main axis of the medicament delivery device extending from the proximal end to the distal end of the medicament delivery device.

In a preferred embodiment, the cap is attached to the further components of the subassembly by means of a thread connection or a bayonet connection. Thus, for removing the cap, a rotation about the longitudinal axis as defined by the thread or the bayonet connection is preferably required.

In a particularly preferred embodiment, the subassembly additionally comprises a guide nut having a first guiding element, which is engageable with a second guiding element of the cap in such a way that the rotation of the cap about the longitudinal axis results in a proximal displacement of the cap relative to the guide nut. Thus, due to the preferred provision of the first and second guiding elements, the rotational movement of the cap is overlaid by a simultaneous proximal displacement.

The cap is preferably arranged radially inside of the guide nut. The guide nut is preferably fixedly attachable to the housing of the medicament delivery device. Embodiments are conceivable, in which the guide nut is made in one piece with the housing. Preferred, however, is an embodiment, in which the guide nut forms a separate independent part, which can be attached to the housing, either directly or indirectly, i.e. via further components.

The first and second guiding elements can for example be in the form of threads. Preferably, however, is an embodiment, in which the first guiding element of the guide nut is in the form of a helical inner groove or in the form of a helical slot. The second guiding element of the cap is then preferably in the form of one, two or more outwardly directed protrusions, which can for example be formed by a nose, a lug or a tab, which is adapted to engage with the groove or slot of the guide nut.

A rotation of the cap about the longitudinal axis preferably results in a displacement of the cap in the proximal direction and of the hub in the distal direction. This can particularly be achieved, if the first or second guide structure is in the form of a helical groove or slot and if the first or second guiding element is also in the form of a helical groove, wherein the two helical grooves are oriented in opposite directions. The guide structures and the guiding elements are preferably designed such that the hub is displaced further in the distal direction than the cap in the proximal direction. In this way, an optimal piercing of the membrane can be guaranteed. The first guiding element and the second guiding element are preferably designed such that a 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. In this way, it can be guaranteed that when the cap is removed, the membrane is pierced and the medicament delivery device is thus ready for injection. The subassembly preferably additionally comprises a retainer having a guide slot, which is engageable with a guide lug of the hub, in order to guide the displacement of the hub, in particular to guide the displacement of the hub along the main longitudinal axis of the medicament delivery device. Thus, the guide slot preferably extends along the main longitudinal axis of the medicament delivery device. In a preferred embodiment, the hub comprises two guide lugs, which are advantageously arranged on diametrically opposite positions of the hub. The retainer is preferably made as a whole in one piece and advantageously injection moulded from a plastics material.

In a particularly preferred embodiment, the guide lug or guide lugs not only serve to guide the hub along the guide slot of the retainer, but also form the first guide structure of the hub. Thus, the guide lug(s) in this case not only engage with the guide slot of the retainer, but also with the second guide structure of the cap. This can easily an in a constructively simple manner be achieved, in that the guide lug(s) extend through the guide slot of the retainer and further into the second guide structure of the cap.

The retainer preferably serves to fixate the subassembly to a housing of the medicament delivery device. The fixation of the retainer to the housing is preferably effected by means of a snap-on connection, in order to facilitate the assembly of the device. Fastening hooks are advantageously provided on the retainer, in order to enable a particularly simple attachment of the retainer on the housing. The attachment of the retainer on the housing is preferably such that the retainer cannot be rotated relative to the housing. The retainer preferably also serves to attach the guide nut and comprises corresponding attachment means for this purpose. The attachment of the guide nut on the retainer is preferably effected by means of a snap- on connection. The guide nut and the retainer could basically also be made together in one piece. In order to facilitate or even enable the assembly of the device, a design of the guide nut and the retainer in the form of two separate parts is preferred. The retainer preferably comprises a circumferential seal, in order to seal the retainer against the guide nut and/or against the cap, when the subassembly is it its assembled state. The circumferential seal can, but does not need to be, made in one piece with the rest of the retainer.

In order to lock the piercing element in the second position, the hub preferably comprises a first snap element and the retainer comprises a second snap element, which are adapted to engage with each other as soon as the piercing element adopts 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, formed in particular by means of apertures. Thus, due to the first and second snap elements, the hub and, thus, the needle, which preferably forms the medicament delivery element and the piercing element, is locked when the piercing element is in its second position. As a result, the user preferably cannot remove the medicament delivery element from the device anymore, which considerably increases the safety of the medicament delivery device. In a preferred embodiment, the hub is V-shaped in cross-sectional view, such that a longitudinal groove is formed, which is open towards one side. The longitudinal groove preferably serves to accommodate the needle therein, which results in a particularly easy placement and subsequent bonding, i.e. gluing, of the needle to the hub in the assembly process.

The subassembly can additionally comprise an outer cap, which is attached to the cap via a latching mechanism that allows a rotation of the outer cap relative to the cap about the longitudinal axis in only one rotation direction. The provision of the outer cap and the latching mechanism can effectively prevent incorrect manipulation of the subassembly by forcibly turning the cap in the wrong direction of rotation.

The present invention further provides a medicament delivery device comprising the subassembly as indicated.

Exemplary types of drugs or medicaments that could 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, reversal agents, radioligand therapies, radioisotopes and/or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti- apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C 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 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 A (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 domains (TIGIT) modulators, V-domain Ig suppressor 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; also known as cluster of differentiation 223 or 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-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 (CDwi23) 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 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta- lb, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, 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, ixekizumab, and immune globulins. Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as 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, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

Exemplary drugs that could 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 limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5- fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

Exemplary drugs that could 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]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U/mL Heparin Lock Flush Solution, or 5000 U/mL Heparin Lock Flush Solution.

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

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA/CO, EMA/EP, EP/EMA, TP/TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a/an/the element, apparatus, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.

Figure 1 shows a perspective view of a subassembly of a medicament delivery device according to a first inventive embodiment;

Figure 2 shows the subassembly of Fig. 1, with the guide nut removed;

Figure 3 shows the subassembly of Fig. 2, with the cap removed;

Figure 4 shows the isolated hub with the needle of the subassembly of Fig. 1;

Figure 5 shows the subassembly of Fig. 1, with the cap rotated and with the needle in a piercing position, the cap shown transparent for illustration purposes;

Figure 6 shows the subassembly of Fig. 5, with the cap removed;

Figure 7a shows a central cross-sectional view through the guide nut of the subassembly of Fig. 1;

Figure 7b shows a central cross-sectional view through the guide nut of the subassembly of Fig. 1 onto the plane Vllb-VIIb marked in Fig. 7a;

Figure 8a shows a central cross-sectional view through the cap of the subassembly of Fig. 1;

Figure 8b shows a central cross-sectional view through the cap of the subassembly of Fig. 1 onto the plane Vlllb-VIIIb marked in Fig. 8a;

Figure 9a shows a central cross-sectional view through the retainer of the subassembly of Fig. 1;

Figure 9b shows a central cross-sectional view through the retainer of the subassembly of Fig. 1 onto the plane IXb-IXb marked in Fig. 9a;

Figure 10 shows a central cross-sectional view through the subassembly of Fig. 1, with the needle being in a first position distant from the membrane of the medicament container;

Figure 11 shows the same cross-sectional view as in Fig. 10, but with the cap rotated and with the needle in a second position piercing the membrane of the medicament container; Figure 12 shows the same cross-sectional view as in Fig. 11, but with the cap removed;

Figure 13 shows a perspective view of a medicament delivery device comprising a subassembly according to a second inventive embodiment;

Figure 14 shows the medicament delivery device of Fig. 13, with the outer cap removed;

Figure 15 shows the medicament delivery device of Fig. 14, with the cap removed;

Figure 16 shows the medicament delivery device of Fig. 15, with the housing removed;

Figure 17 shows the medicament delivery device of Fig. 16, with the cover sleeve and the cover ring removed;

Figure 18 shows the medicament delivery device of Fig. 17, with the cover spring, the rotator and the guide nut removed;

Figure 19 shows the medicament delivery device of Fig. 18, with the latching unit and the cartridge holder removed;

Figure 20 shows the medicament delivery device of Fig. 19, with the retainer removed;

Figure 21a shows a perspective view of the cap of the medicament delivery device of Fig. 13;

Figure 21b shows a central cross-sectional view through the cap of Fig. 21a;

Figure 21c shows a central cross-sectional view through the cap of Fig. 21a onto the plane XXIc-XXIc marked in Fig. 21b;

Figure 22a shows a partial side view of the hub with the needle of another inventive variant of a subassembly;

Figure 22b shows a partial side view of the same hub and needle as in Fig. 22a, but from a perpendicular viewing angle with respect to the one of Fig. 22a;

Figure 22c shows a partial perspective view of the same hub and needle as in Fig. 22a;

Figure 23a shows a side view of another variant of a retainer adapted to be used in combination with the hub and needle as shown in Fig. 22a;

Figure 23b shows a central cross-sectional view of the retainer of Fig. 23a;

Figure 23c shows a perspective view of the retainer of Fig. 23a; Figure 24 shows a perspective view of a subassembly of a medicament delivery device according to a third inventive embodiment, without guide nut and cap;

Figure 25a shows the isolated hub with the needle of the subassembly of Fig. 24a, from a first viewing direction;

Figure 25b shows the isolated hub with the needle of the subassembly of Fig. 24a, from a second viewing direction; and

Figure 25c shows a cross-sectional view of the isolated hub with the needle of the subassembly of Fig. 24a.

Figure 26 shows a perspective view of a subassembly of a medicament delivery device according to a fourth inventive embodiment;

Figure 27 shows an exploded perspective view of the subassembly shown in Figure 26;

Figure 28 shows an exploded perspective view of a retainer of the subassembly shown in Figure 26;

Figure 29 shows a cross-sectional view of the sub-assembly shown in Figure 26;

Figures 30a and 30b show cross-sectional views of the sub-assembly shown in Figure 26 with a medicament container;

Figure 31 shows a perspective view of a subassembly of a medicament delivery device according to a fifth inventive embodiment;

Figure 32 shows an exploded perspective view of the subassembly shown in Figure 3i;

Figures 33a and 33b show perspective views of a cap of the subassembly shown in Figure 31;

Figure 34 shows a cross-sectional view of the subassembly shown in Figure 31.

DETAILED DESCRIPTION

The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example 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 parts of different examples, embodiments or variants, but having the same or a similar function are designated by the same reference numerals in the figures.

Figures 1 to 12 show a first inventive embodiment of a subassembly 2 of a medicament delivery device in different views and states. The subassembly 2 comprises a needle 21, a hub 22, cap 23, a guide nut 24 and a retainer 25, as can be seen in Figures 1 to 4.

The needle 21, which as a whole is made in one piece, comprises a first proximal portion that forms a medicament delivery element 211 and a second distal portion that forms a piercing element 212. The needle 21 has a continuous inner lumen that opens proximally at a pointed proximal end 2111 formed by the medicament delivery element 211 and distally at a pointed distal end 2121 formed by the piercing element 212.

The needle 21 extends along a longitudinal direction through the hub 22, as it is shown in Figure 4. The needle 21 is fixedly attached to the hub 22 in such a manner, e.g. by means of a suitable adhesive, that it cannot be displaced or rotated relative to the hub 22.

The hub 22 is made as a whole in one piece, in particular by means of injection moulding and from a plastics material. The hub 22 comprises two guide lugs 221 that are transversally projecting outwardly on opposite sides of the needle 21. The hub 22 further comprises two flexible arms 222, which extend in parallel to each other and to the needle 21 in proximal direction. On each of the flexible arms 222, a snap hook 223 is provided which projects outwardly on opposite sides of the needle 21 in a perpendicular direction with respect to the guide lugs 221. Each of the snap hooks 223 forms a stop surface facing in the proximal direction.

The cap 23 is adapted to cover the needle 21 in both the radial and the proximal direction, in order to keep the needle 21 in a sterile condition and to reduce the risk for the user to accidentally get into contact with the needle 21 before the injection. For this purpose, the cap 23 comprises a proximal top surface and an approximately cylindrical lateral surface. A marker 231 is provided on the top surface, in order to visualize the rotational state of the cap 23 in the figures. Thus, the marker 231 only serves for illustration purposes. At the inner face of the cylindrical lateral surface of the cap 23, a guide track 232 is provided. The guide track 232 is formed by a helical groove extending longitudinally from the distal end to just about the middle of the cap 23. The longitudinal direction of the cap 23 is defined by the central main longitudinal axis 235 of the cap 23, which also forms the central main longitudinal axis of the helical guide track 232. At the distal end of the cap 23, two guide protrusions 233 are provided that radially extend outwardly on opposite sides of the cap 23. The cap 23 is made as a whole in one piece, preferably from a plastics material by means of injection moulding.

The guide nut 24, which is shown in isolation in Figures 7a and 7b, overall has a hollow cylindrical design and is made as a whole in one piece, preferably from a plastics material by means of injection moulding. In two rectangular apertures formed on opposite sides in a distal region of the guide nut 24, a latching hook 241 is provided in each case. The latching hooks 241 extend in proximal direction and comprise a radially inwardly directed stop surface at their free ends, which faces in the proximal direction in each case. The latching hooks 241 have a certain flexibility that allows them to slightly flex inwardly.

In the proximal region, the guide nut 24 comprises two helical guide slots 242 which extend on opposite sides of the guide nut 24 over an angular area of not quite 180° in each case. The proximal ends of the guide slots 242 are each arranged slightly distant from the proximal end of the guide nut 24 and open into a proximal longitudinal groove 243. Along the distal direction, the guide slots 242 extend to just about the middle of the guide nut 24, where the ends of the guide slots 242 in each case open into a distal longitudinal groove 244. The proximal longitudinal grooves 243 and the distal longitudinal grooves 244 are provided on the inner surface of the guide nut 24 and each extend along the longitudinal direction.

The retainer 25, which is shown in isolation in Figures 9a and 9b, comprises a central through-going opening extending along the longitudinal direction. From a central cylindrical portion 250 of the retainer 25, two fastening hooks 251 extend on diametrically opposite sides in distal direction. The fastening hooks 251 in each case comprise a radially outwardly directed stop surface at their free ends, which faces the proximal direction and serve to fixate the retainer 25 and, thus, the subassembly 2 on a housing of the medicament delivery device. A longitudinal web 252 is provided on the outer surface of each fastening hook 251. The longitudinal webs 252, which extend only a short distance in the distal direction, serve to prevent a rotation of the retainer 25 relative to the housing in the assembled state of the medicament delivery device. From the proximal end of the central cylindrical portion 250 of the retainer 25, a proximal cylindrical portion extends in proximal direction. The proximal cylindrical portion has a considerably smaller diameter than the central cylindrical portion 250 of the retainer 25 and is divided by a longitudinal guide slot 257 that is provided along the entire longitudinal extension of the proximal cylindrical portion and transversally extends through the proximal cylindrical portion. The longitudinal guide slot 257 serves to guide the guide lugs 221 of the hub 22. At its proximal end, the longitudinal guide slot 257 comprises a constriction 258, which serves to latch the guide lugs 221 in the proximal position of the hub 22, when the needle 21 is arranged distant from the membrane 82 of the cartridge 8, i.e. when the membrane 82 is still intact (see e.g. Figures 3, 9a and 10 and the explanations further below). In the region of the proximal end of the proximal cylindrical portion of the retainer 25, two rectangular apertures 253 are provided on diametrically opposite sides of the retainer 2. By means of engagement with the snap hooks 223, the apertures 253 serve to lock the hub 22 in its distal position, when the membrane 82 of the cartridge 8 is pierced by the piercing element 212 (see e.g. Figures 6 and 11 and the explanations further below).

For fastening the guide nut 24 to the retainer 25, retaining protrusions 255 are provided on diametrically opposite sides on the proximal end of the central cylindrical portion of the retainer 25. The retaining protrusions 255 extend radially outwards and comprise a stop surface facing in the distal direction, in order to retain latching hooks 241 of the guide nut 24, as shown in e.g. Figure 10. In order to prevent a rotation of the guide nut 24 relative to the retainer 25, the retainer 25 comprises a radially extending radial knob 256 that is positioned within a distally open aperture provided in the side wall of the guide nut 24, when the guide nut 24 is fastened to the retainer 25.

In order to seal the retainer 25 against the cap 23, a circumferential seal 259 is provided at the proximal end of the central cylindrical portion 250 of the retainer 25. The circumferential seal 259 comprises a plurality of circumferential ribs and is preferably made of a softer material than the rest of the retainer 25. The circumferential seal 259 can be moulded onto the central cylindrical portion 250, e.g. in a two-component injection moulding process. For assembly of the subassembly 2, in a first step, the hub 22 with the needle 21 is connected to the retainer 25 by engaging the guide protrusions 223 in the constriction 258 provided at the proximal end of the longitudinal guide slot 257 (see Figure 10). In a second step, the cap 23 is moved in the distal direction onto the proximal cylindrical portion of the retainer 25. When the guide track 232 engages the guide lugs 221, the cap 23 is moved further onto the retainer 25 by a screwing movement, until its distal end is pressed onto the circumferential seal 259. In a further step, the guide nut 24 is moved in the distal direction onto the retainer 25 until the latching hooks 241 come into engagement with the retaining protrusions 255. In doing so, the guide protrusions 233 of the cap 23 engage the distal longitudinal grooves 244 of the guide nut 24 and eventually the distal end of the guide slot 242. As a result, the subassembly 2 adopts an assembled, initial stage as shown in Figures 1 to 3 and 10. In this initial stage, the subassembly 2 can be transported and stored. By means of the fastening hooks 251, the subassembly 2 can be fastened to the housing of a medicament delivery device, which can be done before or after transport and storage.

In use, the medical personnel or the user basically simply needs to screw off the cap

23, in order to prepare the subassembly 2 for the injection. In doing so, the guide protrusions 233 of the cap 23 are guided along the guide slots 242 of the guide nut

24, which results in a proximal movement of the cap 23 relative to the guide nut 24. At the same time, due to the engagement of the guide lugs 221 of the hub 22 with the guide track 232 of the cap 23, the hub 22 is displaced distally with the attached needle 21. During this displacement of the hub 22, the guide lugs 221 are guided by the longitudinal guide slot 257 of the retainer 25, which also prevents a rotation of the hub 22 relative to the retainer 25. Due to this distal displacement of the hub 22, the piercing element 212 pierces the membrane 82 and gets into fluid connection with the interior of the cartridge 8. The subassembly is in a state as shown in Figure 11. After the cap 23 has been fully rotated, the guide protrusions 233 engage 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 (Figure 12).

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

On the cap 23 of the subassembly 2, an outer cap 26 is attached, as shown in Figure 13. The cap 26 is such engaged by an outer latching element 234 of the cap 23 (Figures 14 and 21a), that, similar to a free wheel, 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 medicament delivery device 1 as shown in Figures 13 to 21c is identical or at least similar to the one of Figures 1 to 12.

As can be seen in Figures 13 to 15, the medicament delivery device 1 comprises a cylindrical outer housing 3. The housing 3 comprises windows 31 on diametrically opposite sides, in order to allow the user to see the filling level of the medicament container, i.e. the cartridge 8.

Inside of the housing 3, a cover unit 4 is provided, as can be seen in Figure 16. The cover unit 4 serves to radially cover the needle 21, in order to prevent the user from accidentally contacting the medicament delivery element 211 before and after injection. For this purpose, the cover unit 4 comprises 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 to 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, in which the medicament delivery element 211 is radially covered before and after the injection. For the injection, the medicament delivery device 1 is pressed with its proximal end 11 against the body of the user, which causes the cover sleeve 41 and the cover ring 42 to be retracted against the force exerted by cover spring 43, as it is shown in Figure 16. Due to the retraction of the cover unit 4, the medicament delivery element 211 is exposed and ready for the injection. The cover sleeve 41 has windows 413, in order to allow the user to see the filling level of the cartridge 8 through the windows 31 of the housing 3. Radially inside of the cover sleeve 41, a rotator 5 is provided in the distal end of the medicament delivery device 1, as shown in Figure 17. The rotator 5 has a guiding track 51 on its radial outer side, which is in engagement with a guide protrusion 412 on the inner side of the cover sleeve 41. Owing to the engagement of the guiding track 51 and the guide protrusion 412, the cover sleeve 41 is locked in its longitudinal position after it has been retracted distally and then extended proximally relative to the housing 3, i.e. after the injection has been completed and the device has been removed from the patient's body.

Arranged proximally of the rotator 5 is the cartridge holder 6 (Figures 17 and 18). The cylindrical cartridge holder 6, which forms an inner space for accommodating a cartridge 8, is rotationally and radially centralized by means of longitudinal ribs 61 forming a longitudinal indentation at the outer side and a longitudinal elevation at the inner side of the cartridge holder 6. Towards the inside, the longitudinal ribs 61 serve to radially centralize the cartridge 8 and towards the outside, the longitudinal ribs 61 mate with respective longitudinal ribs 411 of the cover sleeve 41, in order to prevent a rotation of the cartridge holder relative to the cover sleeve 41.

The cartridge holder 6 comprises a stop element 62 that radially protrudes outwardly through a longitudinal aperture 414 of the cover sleeve 41 (see Figure 16) and an aperture 32 of the housing 3 (see Figure 15). Due to the engagement of the stop element 62 with the aperture 32 of the housing 3, the cartridge holder 6 is fixated to the housing 3 in such a way, that it can neither be rotated nor displaced relative to the housing 3. The engagement of the stop element 62 with the longitudinal aperture 414 of the cover sleeve 41 effects a longitudinal guidance for the cover sleeve 41 relative to the cartridge holder 6 in such a way, that the cover sleeve 41 cannot be rotated relative to the cartridge holder 6.

At its proximal end, the cartridge holder 6 has longitudinal and proximally open slits 64 on diametrically opposite sides, that mate with the longitudinal webs 252, in order to prevent a rotation of the retainer 25 relative to the cartridge holder 6. A retaining element 65 in the form of a radially inwardly protruding latching hook serves to distally retain the cartridge 8 inside of the cartridge holder 6.

In the interior of the cartridge holder 6, the cartridge 8 is arranged which usually has an overall elongated cylindrical shape with a neck and a proximal cartridge head 81, as it is shown in Figures 19 and 20. The proximal surface of the cartridge head 81 forms an opening which is sealed by a membrane 82. For the injection, the membrane 82 is pierced by the needle 21, as shown in Figure 20.

The actual injection is triggered by the retraction of the cover sleeve 41, which releases an injection unit 9 that causes a plunger to be forwarded into the cartridge 8 by means of an injection spring 91 (see Figures 19 and 20). By means of the forward movement of the plunger, the medicament is expelled from the inside of the cartridge 8 through the needle 21 and into the body of the patient. The injection spring 91 is longitudinally guided by a spring guide 92 that longitudinally extends from the distal end into the injection spring. The release of the injection unit 9 by means of the cover sleeve 41 is based on a mechanism well known to the skilled person.

Arranged radially inside of the rotator 5 and of the cartridge holder 6, but outside of injection spring 91 is a cylindrical latching sleeve 7, which has a longitudinally extending latching rail 71 on its outer surface, as can be seen in Figure 18. The latching sleeve 7 serves to adjust the distance between the distal end and the proximal end and thus the pretension of the injection spring 91 in the pretensioned, i.e. compressed, state of the injection spring 91. This is achieved by means of a latching nose 66 of the cartridge holder 6 engaging with the latching rail 71. Radially outwardly extending protrusions 72 arranged at diametrically opposite sided at the distal end of the latching sleeve 7 engage respective indentations at the outer side of the rotator 5, in order to limit the rotational movement of the rotator 5.

Figures 22a to 22c show a variant of a hub 22 with a needle 21 according to another also inventive embodiment of a subassembly 2. The hub 22 as shown in Figures 22a to 22c is adapted to interact with the variant of a retainer 25 as shown in Figures 23a to 23c. In contrast to the previous embodiments, the one of Figures 22a to 22c comprises a hub 22, which does not have any flexible arms 222 with snap hooks 223. Instead, the hub 22 here comprises guide lugs 221 with snap notches 224. The snap notches 224 are adapted to be engaged by retaining hooks 254 provided at the longitudinal guide slot 257 of the retainer 25, in order to lock the hub 22 in its distal position after having pierced the membrane 8. The retainer 25 thus differs from the one of the previous embodiments by having retaining hooks 254 instead of apertures 253- Figure 24 shows a needle 21 attached to a hub 22 that is held by a retainer 25 of a subassembly according another inventive embodiment. The embodiment of Figure 24 differs from the ones of Figures 1 to 23c in particular by the design of the hub 22. As can be seen in Figures 25a and 25b and in particular in Figure 25c, the hub 22 is V-shaped in cross-sectional view, such that a longitudinal groove is formed, which is open towards one side. During assembly, the longitudinal groove allows particularly easy placement and subsequent bonding, i.e. gluing, of the needle 21 to the hub 22. Furthermore, the hub 22 of the embodiment of Figures 24 to 25c has the advantage of being suitable for carrying needles 21 of different diameters. In contrast, the hub designs of e.g. Figures 4 and 22a-22c require a dedicated hub 22 for each diameter of a needle 21, in order to maintain proper gaps for the glue to enter and not to allow too much play to prevent excessive tilt of the needle axis relative to the retainer axis. Also, with the embodiment of Figures 24 to 25c, thanks to the 'side loading', the mounting of the needle 21 to the hub 22 can be done without the need to have a mechanical contact with either the proximal end 2111 or the distal end 2121 of the needle 21. Inserting the needle 21 into a through-going hole as is done in the embodiments of Figures 4 and 22a-22c, requires some sort of mechanical stop, which means that one of the ends 2111 and 2121 needs to be contacted, which might result in some deformation, which in turn might affect the piercing performance. Figures 26 to 30b show a variant of the medicament delivery device 1 in which the retainer 22 is modified. In most respects, the embodiment illustrated in Figures 26 to 30b is identical to the embodiment illustrated in Figures 1 to 12. However, in the embodiment illustrated in Figures 26 to 30b, the retainer 25 comprises an interface 280 and an adapter 281. Moreover, the retainer 25 serves not only to receive the medicament container 8 at the distal end of the sub-assembly 2, but to secure the medicament container 8 to the subassembly 2. This can avoid the need for additional securing means to be provided elsewhere in the medicament delivery device 1 to secure the medicament container 8 in place.

In more detail, the retainer 25 of the embodiment illustrated in Figures 26 to 30b comprises a port 260 for accommodating the head 81 of the medicament container 8. Two protrusions 261 are provided on an inside wall of the port 260. The protrusions 261 are integrally formed with the retainer 25. The protrusions 261 may be deflected when the head 81 of the medicament container 8 is accommodated in the port 260 so as to provide a biasing force that urges the head 81 in a proximal direction to secure the head 81 in the port 260. Specifically, as can be seen most clearly in Figure 30b, the protrusions 261 grip a distally facing surface of the head 81 of the medicament container 8. Since the protrusions 261 extend radially inwardly and are inclined in a proximal direction they may snap-fit into the position shown in Figure 30b. The protrusions 261 taper in a radially inwardly direction. This assists with locating the protrusions 261 in their position between the head 81 of the medicament container 8 and a shoulder of the body of the medicament container 8.

In the illustrated embodiment, two protrusions 261 are provided. However, in other embodiments, other numbers of protrusions 261, e.g. two or more, may be present. Typically, the protrusions 261 are spaced equally in a circumferential direction.

One or more distally facing surfaces 284 are provided for engaging the head 81 of the medicament carrier 8. The protrusions 261 and distally facing surfaces 284 are arranged such that the head 81 is held between the one or more distally facing surfaces 284 and the protrusion(s) 261. In the illustrated embodiment, each of the distally facing surfaces 284 is a surface of a tab extending radially inwardly from a wall of the retainer 25. It can also be seen that he protrusions 261 and the distally facing surfaces 284 are offset from one another circumferentially. In other embodiments, the distally facing surface 284 may be annular.

The retainer 25 comprises an interface 280 and an adapter 281. The port 260 and protrusions 261 are provided on the adapter 281 and the adapter 281 is mountable to the interface 280. The distally facing surface(s) 284 are provided on the interface 280, although in other embodiments these may be provided on the adapter 281. This means that differently sized and shaped medicament containers 8 may be accommodated using different adapters 281, but the interface 280 and other components of the subassembly can be common to a variety of differently sized and shaped medicament containers 8. This reduces manufacturing costs and simplifies assembly.

In the illustrated embodiment, the adapter 281 snap-fits to the interface 280. In more detail, the adapter 281 has mounting protrusions 282 and the interface 280 has mounting recesses 283. The mounting protrusions 282 and mounting recesses 283 cooperate with one another to secure the adapter 281 to the interface 280. Specifically, the mounting protrusions 282 and mounting recesses 283 snap-fit to one another. In the illustrated embodiment, there are four mounting protrusions 282 and four mounting recesses 283, but in other embodiments different numbers of mounting protrusions 282 and mounting recesses 283 may be utilised. In yet 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 fixings may be provided for attaching the adapter 281 to the interface 280.

Figures 31 to 34 show a variant of the medicament delivery device 1 in which the operation of the sub-assembly is modified. In most respects, the embodiment illustrated in Figures 31 to 34 is identical to the embodiment illustrated in Figures 1 to 12. However, in the embodiment illustrated in Figures 31 to 31, the cap 23 is adapted to be displaced axially in a proximal direction to cause the piercing element 212 to pierce the membrane 82 of the medicament container, and to not rotate. In more detail, a guide nut 24 disposed between the hub 22 and the cap 23. The hub 22 has the first guide structure 221 an the cap 23 has the second guide structure 232. The first guide structure 221 and the second guide structure 232 are adapted to engage with the guide nut 24 in such a way that axial displacement of the cap 23 along a longitudinal axis 235 in a proximal direction results in a rotation of the guide nut 24 that in turn causes displacement of the hub 22 along the longitudinal axis 235 in a distal direction and displacement of the piercing element 212 from the first position to the second position.

The retainer 25 has a guide slot 257 which is engageable with the first guide structure 221 of the hub 22 to guide 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. The first guide structure 221 on the hub 22 comprises two lugs, and the guide nut 24 has one or more inwardly directed helical grooves 322, each inwardly directed helical groove 322 cooperating with one of the lugs. The second guide 232 structure on the cap 23 is one or more radially inwardly directed helical grooves, and the guide nut 24 has one or more radially outwardly directed lugs 323 each for cooperating with one of these radially inwardly directed helical grooves of the cap 23. The one or more inwardly directed helical grooves 322 of the guide nut 24 are oriented oppositely to the one or more inwardly facing helical grooves of the cap 23. That is, one may progress clockwise in say the proximal direction and the other may extend counterclockwise in that direction. In other embodiments, different numbers of lugs and helical grooves may be provided, e.g. one or more. It will also be appreciated that in other embodiments the lugs may be replaced with slots and the grooves with threads for much the same effect.

As the cap 23 is displaced along the longitudinal axis 235 in a proximal direction, the lugs of the guide nut 24 are urged circumferentially by the helical grooves of the cap 23, causing the guide nut 24 to rotate. The cap 23 is prevented from rotating due to the presence of ribs 320 on its outer surface that cooperate with grooves 321 provided in the cover unit 42, which itself is secured against rotation elsewhere. Also, the guide nut 24 is prevented from being displaced axially by the retainer 25, e.g. by proximally and distally facing retaining surfaces provided on the retainer 25 to cooperate with the guide nut 24. As the guide nut 24 rotates, the lugs of the hub 22 travel in the helical grooves of the guide nut 24, causing the hub 22 to be displaced along the longitudinal axis 235 in a distal direction from the first position to the second position.

The cap 23 has a knob 310 at a proximal end for facilitating gripping of the cap 23 by a user to apply a force that causes the axial displacement of the cap 23.

The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims. It is particularly to be noted that the combinations of elements, components and parts as shown in the figures are merely to be understood as non-limiting examples. The individual elements, components and parts of the various embodiments as described and/or shown in the figures can basically be interchanged with each other as desired and supplemented, for example, with further elements.

Claims

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

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

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

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

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

6. The subassembly (2) of any of the preceding claims, additionally comprising a retainer (25) having a guide slot (257) which is engageable with a guide lug (221) of the hub (22), in order to guide the displacement of the hub (22).

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, in order to lock the piercing element (212) in the second position.

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

9. The subassembly (2) of any of the preceding claims, additionally comprising an outer cap (26) which is attached to the cap (23) via a latching mechanism that allows a rotation of the outer cap (26) relative to the cap (23) about the longitudinal axis (235) in only one rotation direction.

10. The subassembly (2) of any of the preceding claims, wherein the medicament delivery element (211) and the piercing element (212) are fixedly attached to the hub (22), which is preferably made as a whole in one piece.

11. The subassembly (2) of any of the preceding claims, wherein the second guide structure (232) of the cap (23) is formed by a helical groove.

12. A medicament delivery device (1) comprising the subassembly (2) as set out in any one of the preceding claim.

13. A subassembly (2) of a medicament delivery device (1) for delivering a medicament from a medicament container (8) to a human or animal patient, wherein the subassembly (2) comprises: a medicament delivery element (211) with a proximal end (2111), through which the medicament can be delivered to the patient; a piercing element (212) for piercing a membrane (82) of the medicament container (8), in order to fluidly connect the medicament delivery element (211) to the medicament container (8); a hub (22), which is adapted to displace the piercing element (212) from a first position, in which the piercing element (212) is arranged distant from the membrane (82) of the medicament 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 medicament delivery element (211) prior to the use of the medicament delivery device (1); and a retainer (25) that serves to receive the medicament container (8) at a distal end of the sub-assembly (2), which retainer (25) comprises a port (260) for accommodating a head (81) of the medicament container (8) and one or more protrusions (261) that is/are deflected, when the head (81) is accommodated in the port (260), to provide a biasing force that urges the head (81) in a proximal direction to secure the head (81) in the port (260).

14. The subassembly (2) of claim 14, wherein there is more than one protrusion (261) and the protrusions (261) are spaced equally in a circumferential direction.

15. The subassembly (2) of claim 13 or claim 14, wherein the protrusion(s) (261) extend radially inwardly and inclined in a proximal direction.

16. The subassembly (2) of any one of claims 13 to 15, wherein the protrusion(s) (261) taper(s) in a radially inwardly direction.

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

18. The subassembly (2) of any one of claims 13 to 17, further comprising a one or more distally facing surfaces (284) for engaging the head (81) of the medicament carrier (8), such that the head (81) is held between the one or more distally facing surfaces (284) and the protrusion(s) (261).

19. The subassembly (2) of claim 18, wherein each of the distally facing surfaces (284) is a surface of a tab extending radially inwardly 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), wherein the port (260) and protrusion(s) (261) are provided on the adapter (281) and the adapter (281) is mountable to the interface (280).

21. The subassembly (2) of claim 20, wherein the adapter (281) snap-fits to the interface (280).

22. 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 mounting recess (283) cooperating with one another to secure the adapter (281) to the interface (280).

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 mounting recesses (283) cooperating with one another to secure the adapter (281) to the interface (280).

24. The subassembly (2) of claim 22 or claim 23, where the mounting protrusion(s) (282) and mounting recess(es) (283) snap-fit to one another.

25. A subassembly (2) of a medicament delivery device (1) for delivering a medicament from a medicament container (8) to a human or animal patient, wherein the subassembly (2) comprises: a medicament delivery element (211) with a proximal end (2111), through which the medicament can be delivered to the patient; a piercing element (212) for piercing a membrane (82) of the medicament container (8), in order to fluidly connect the medicament delivery element (211) to the medicament container (8); a hub (22), which is adapted to displace the piercing element (212) from a first position, in which the piercing element (212) is arranged distant from the membrane (82) of the medicament 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 medicament delivery element (211) prior to the use of the medicament delivery device (1); and a guide nut (24) disposed between the hub (22) and the cap (23), wherein the hub (22) has a first guide structure (221), the cap (23) has a second guide structure (232), and the first guide structure (221) and the second guide structure (232) are adapted to engage with the guide nut (24) in such a way that axial displacement of the cap (23) along a longitudinal axis (235) in a proximal direction results in a rotation of the guide nut (24) that in turn causes displacement of the hub (22) along the longitudinal axis (235) in a distal direction and displacement of the piercing element (212) from the first position to the second position.

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

27. The subassembly (2) of claim 26, wherein the guide nut (24) is mounted on the retainer (25) so as to be rotatable about the longitudinal axis (235).

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

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

30. The subassembly (2) of any one of claims 25 to 29, wherein the second guide (232) structure is one or more radially inwardly directed helical grooves.

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

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 one another to prevent rotation of the cap (23) about the longitudinal axis (252) whilst allowing the axial displacement of the cap (23).

33. The subassembly (2) of claim 32, wherein the other component of the subassembly is a cover unit (42) for covering the medicament 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 for facilitating gripping of the cap (23) by a user to apply a force that causes the axial displacement of the cap (23)