Cap removal aid and assembly therewith

Abstract

The present disclosure is generally directed to a cap removal aid (10) for an injection device (1) and to an assembly with such a cap removal aid (10). The injection device (1) comprises a removable cap (2) and a body (3) having a distal injection end with a needle and an opposite proximal end and defining a longitudinal axis (X), wherein the removable cap (2) is configured for encasing the needle at least partially. The cap removal aid (10) comprises an attachment portion suitable for attaching the cap removal aid (10) to the cap (2) of an injection device (1) and an operating portion with at least one ring (13) suitable to be gripped by a user.

Description

[0001] Sanofi-Aventis Deutschland GmbH

[0002] Description

[0003] CAP REMOVAL AID AND ASSEMBLY THEREWITH

[0004] The present disclosure is generally directed to a cap removal aid which is configured to be attached to a drug delivery device, for example to injection pens which may allow a user to inject, e.g. spring driven and automatically, a preset fixed dose of a medicament (so called auto injectors) or which may allow a user to individually select and inject a fixed dose of a medicament (so called variable dose pens). Such injection devices typically comprise a removable cap and a body having a distal injection end with a needle and an opposite proximal end and defining a longitudinal axis, wherein the removable cap is configured for encasing the needle at least partially.

[0005] Some patients suffer from physical limitations that make it difficult to operate such a device which is often relatively small, similar to the size of a fountain pen. Rheumatism patients may for example not be able to remove a needle cap from a drug delivery device if the removal force exceeds a range of small forces. Taking into account that such drug delivery devices are often disposable devices which are intended to be discarded after use, it is undesired to enlarge these drug delivery device although this may facilitate operation for some users. A more bulky design would increase the packaging size resulting in an increase of transport, packaging and component costs. In addition, bulky drug delivery devices are less accepted by patients who often have to carry the devices with them.

[0006] It is an object of the present disclosure to provide a solution facilitating use of drug delivery devices, especially auto injectors, by impaired patients.

[0007] This object is solved by a cap removal aid as defined in claim 1. The present disclosure is based on the idea that operation of a standard drug delivery device or an only marginally adapted drug delivery device may be significantly facilitated by an, e.g. invention disposable and re-usable, cap removal aid configured to be attached to a drug delivery device, like an auto injector. Such a cap removal aid may comprise at least one additional component configured to interact with the cap of the drug delivery device. The cap removal aid may be delivered with each disposable device or may be provided as re-usable device. The cap removal aid may be configured to be mounted or assembled by the user before injection or upon preparation of a new drug delivery device.

[0008] In more detail, a cap removal aid according to the present disclosure is suitable to be used with an injection device as mentioned above which comprises a removable cap and a body. The cap removal aid comprises an attachment portion suitable for attaching the cap removal aid to the cap of an injection device and an operating portion suitable to be gripped by a user, wherein the operating portion comprises at least one ring. The cap removal aid may consist of a recycled, biodegradable or eco-friendly material. The cap removal aid may be attached to the cap of the injection device and the provision of a ring as an operating portion suitable to be gripped by a user makes it much easier to remove the cap from the device. For example, the at least one ring may have an opening diameter between 1.5 cm and 5 cm, preferably between 2 cm and 3 cm, e.g. about 2.5 cm, which allows a patient to put a finger, e.g. their index finger, through the ring to remove the cap.

[0009] In addition to the improvements in operation of injection devices, such a cap removal aid has the benefit of reduced packaging and transport costs compared to more bulky injection devices. Further, there are reduced component costs if the cap removal aid is designed as a re-usable device. Patient assembling minimizes the handling effort of the final production of injection devices.

[0010] According to an independent aspect of the present disclosure, the cap removal aid may comprise an electronic module, e.g. an electronic dose recording system, configured for determining, storing and / or transmitting data indicative of at least a condition of the drug delivery device or its use. For example, an electronic module may be designed to support treatment adherence by means of a re-usable cap removal aid which may detect cap removal through a sensor, e.g. a mechanical sensor and / or a cap removal force sensor, and which may store and / or transmit data, preferably utilizing a wireless mode of connection, like a Bluetooth Low Energy (BLE) beacon. The electronic module may comprise a proprietary firmware programmed to facilitate the seamless, encrypted transfer of injection data from the cap removal aid to a patient’s electronic device, like a smartphone, thereby allowing patients better control of their treatment regimens. For example, such an electronic module may be configured to capture e.g. cap removal date and time, prevent clogging, issue injection reminders and / or may read out an RFID tag.

[0011] The attachment portion of the cap removal aid may comprise at least one elastically deformable mushroom head configured to be inserted into an opening of the cap of the injection device for permanently or removably fixing the cap removal aid to the cap. In addition or as an alternative, the attachment portion may comprise at least one threaded portion configured to be screwed into an opening of the cap of the injection device. In other words, attachment portion may be configured to be attached to the cap essentially parallel to the longitudinal axis of the device.

[0012] As a further alternative, the attachment portion may comprise a web with lateral protrusions, for example with a dove-tail cross section, configured to be inserted into a groove of the cap of the injection device. In a similar manner, the attachment portion may comprise a guide channel with an internal groove configured to receive a flange or lateral protrusion of the cap of the injection device. For example, the guide channel comprises a rounded clamping surface and / or a snap hook for securing the cap removal aid on the cap. In these examples, the cap removal aid is configured to be attached to the cap essentially perpendicular to the longitudinal axis of the device.

[0013] Still further, the attachment portion may comprise a sleeve configured to encase a portion of the body and / or the cap concentrical with the longitudinal axis. The sleeve may be short in the direction of the longitudinal axis, e.g. like a ring, or may have a length in the direction of the longitudinal axis being up to or even exceeding its diameter. In other words, the sleeve of the cap removal aid may be placed on the device in the same way as a ring is placed on a finger. The operating portion may comprise the at least one ring arranged laterally offset from the sleeve. The sleeve may be configured to engage at least one pin or a flange or a portion having an increased outer diameter of the cap. For example, the attachment portion comprises a slide in ramp supported by an elastically deformable exposed area.

[0014] According to a further alternative, the attachment portion may comprise a swivel bearing configured to receive a bearing pin of the cap of the injection device such that the at least one ring can be swiveled from a storing position in which the ring is concentrically arranged with respect to the longitudinal axis of the injection device and an actuation position in which the ring is arranged parallel to the longitudinal axis. This pivotable connection between the cap and the cap removal aid may be permanent and allows a user to arrange the cap removal aid in the storing position where the cap removal aid does not significantly protrude from the cap or in the actuation position for facilitating cap removal.

[0015] In some injection devices, the cap may be provided with a removable lid closing one end of the cap. If the attachment portion comprises a cap lid having a snap-in interface configured to close and to attach to the cap of the injection device, the cap removal aid could replace such a removable lid.

[0016] According to one aspect, the object may also be solved by an assembly comprising an injection device and a cap removal aid as mentioned above. More specifically, the injection device may comprise a body having a distal injection end with a needle and an opposite proximal end and defining a longitudinal axis, a removable cap configured for encasing the distal end and / or the needle at least partially, a container received in the body and configured to receive a drug or a cartridge filled with a drug, and a dose delivery unit comprising a plunger configured to be axially moved with respect to the container parallel to the longitudinal axis. In this assembly, the cap of the injection device comprises a mounting section and the attachment portion of the cap removal aid is, e.g. removably or permanently, attached to the mounting section of the cap of the injection device. The mounting section of the cap may comprise at least one of an opening, a groove, a laterally protruding pin, a lateral protrusion and a flange adapted to the attachment portion of the cap removal aid.

[0017] In addition or as an alternative to the provision of a cap removal aid as described above, an injection device may comprise a ring or the like operation aid at the proximal end of the body. For example, a ring of the cap removal aid may be attached to the cap and a further ring may be attached to the proximal end of the body such that a user may grip and pull both rings apart to remove the cap from the injection device body.

[0018] As mentioned above, the cap removal aid of the present disclosure is suitable to be used with various different types of drug delivery devices, especially with any kind of injection device having a cap which has to be removed prior to use of the device. An exemplary injection device suitable for use with the cap removal aid is the auto injector device known from EP 3 122400 B1 . Auto injector devices aim to make self-injection easier for patients. A conventional autoinjector may provide the force for administering the injection by a spring, and trigger button or other mechanism may be used to activate the injection. Auto injectors may be single-use or reusable devices. In an example, an autoinjector may comprise a body adapted to hold a medicament container having a needle; a needle shroud telescopically coupled to the body and movable between a first extended position relative to the body in which the needle is covered and a retracted position relative to the body in which the needle is exposed; and a plunger rotationally and slidably disposed in the body. The plunger may be rotatable relative to the body between a first rotational position in which the plunger is engaged to the body and a second rotational position in which the plunger disengages the body. The needle shroud may engage the plunger to rotate the plunger from the first rotational position to the second rotational position when the needle shroud translates from the first extended position to the retracted position. Further, the auto-injector comprises a cap removably coupled to the body.

[0019] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders. As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0020] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0021] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0022] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0023] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0024] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-pal- mitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)- des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl- des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glu- tamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0025] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Vic- toza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rEx- endin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, GRMD-0901 , NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0026] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0027] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Sax- agliptin, Berberine. Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutro- pin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Ter- lipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0028] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Syn- visc®), a sodium hyaluronate.

[0029] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region anti- body-like binding protein having cross-over binding region orientation (CODV).

[0030] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and immunoglobulin single variable domains. Additional examples of antigen-binding antibody fragments are known in the art.

[0031] The term “immunoglobulin single variable domain” (ISV), interchangeably used with “single variable domain”, defines immunoglobulin molecules wherein the antigen binding site is present on, and formed by, a single immunoglobulin domain. As such, immunoglobulin single variable domains are capable of specifically binding to an epitope of the antigen without pairing with an additional immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Hence, the antigen binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

[0032] An immunoglobulin single variable domain (ISV) can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavychain antibody), including a camelized VH or humanized VHH. For example, the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb" or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.

[0033] “VHH domains”, also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e., of “antibodies devoid of light chains”; Hamers-Caster- man et al. 1993 (Nature 363: 446-448). The term “VHH domain” has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VL domains”). For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).

[0034] For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341 : 544), to Holt et al. 2003 (Trends Biotechnol. 21 : 484); as well as to WO 2004 / 068820, WO 2006 / 030220, WO 2006 / 003388. It should also be noted that, although less preferred in the context of the present invention because they are not of mammalian origin, single variable domains can be derived from certain species of shark (for example, the so-called “IgNAR domains”, see for example WO 2005 / 18629).

[0035] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0036] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0037] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0038] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0039] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608- 1 :2014(E), needle-based injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0040] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0041] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0042] The terms “axial”, “radial”, or “circumferential” as used herein may be used with respect to a longitudinal axis of the injection device, the cartridge, the body, the cartridge holder or the cap. "Distal" is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards dispensing end of the injection device. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged to face away from or point away from the dispensing end. The dispensing end may be the needle end where a needle unit is or is to be mounted to the device, for example.

[0043] In the following, non-limiting, examples of the electronic add-on module, the drug delivery device and the assembly of the drug delivery device and the electronic add-on module are described in more detail by making reference to the drawings, in which:

[0044] Figure 1A shows a drug delivery device with a separate cap removal aid according to a first alternative of the present disclosure;

[0045] Figure 1 B shows a drug delivery device with attached cap removal aid of Figure 1A;

[0046] Figure 1C in sectional views a detail of Figure 1 B;

[0047] Figure 1 D in a sectional view an alternative to Figure 1C;

[0048] Figure 2A shows a drug delivery device with a separate cap removal aid according to a second alternative of the present disclosure;

[0049] Figure 2B shows a drug delivery device with attached cap removal aid of Figure 2A;

[0050] Figure 2C shows an alternative drug delivery device with attached cap removal aid of Figure 2B;

[0051] Figure 3A shows a drug delivery device with a separate cap removal aid according to a third alternative of the present disclosure;

[0052] Figure 3B shows a drug delivery device with attached cap removal aid of Figure 3A;

[0053] Figure 3C shows an alternative cap removal aid; Figure 4A shows a drug delivery device with a separate cap removal aid according to a fourth alternative of the present disclosure;

[0054] Figure 4B shows a drug delivery device with attached cap removal aid of Figure 4A;

[0055] Figure 4C shows an alternative to Figure 4B;

[0056] Figure 4D shows a further alternative to Figure 4B;

[0057] Figure 5A shows a drug delivery device with a separate cap removal aid according to a fifth alternative of the present disclosure;

[0058] Figure 5B shows a sectional view of the drug delivery device with attached cap removal aid of Figure 5A;

[0059] Figure 5C shows an alternative drug delivery device;

[0060] Figure 5D shows a sectional view of the drug delivery device of Figure 5C with attached cap removal aid;

[0061] Figure 6A shows a cap removal aid according to a sixth alternative of the present disclosure;

[0062] Figure 6B shows a drug delivery device with pre-assembled cap removal aid of Figure 6A;

[0063] Figure 6C shows the drug delivery device with the cap removal aid of Figure 6A in a further configuration;

[0064] Figure 7A shows a drug delivery device with pre-assembled cap removal aid according to a seventh alternative of the present disclosure; Figure 7B shows the drug delivery device with the cap removal aid of Figure 7A in a further configuration;

[0065] Figure 8A shows components of a drug delivery device and a cap removal aid according to an eighth alternative of the present disclosure;

[0066] Figure 8B shows the cap of the drug delivery device of Figure 8A; and

[0067] Figure 8C shows the cap removal aid of Figure 8A attached to a component of.

[0068] In the Figures, identical elements and components as well as identical elements and components in different examples or embodiments, i.e. elements and components acting identical or provided for the same purposes but belong to different examples, are provided with the same reference signs.

[0069] Figures 1A and 1 B schematically depict an injection device 1 having a distal end (left lower end in the Figures) and an opposite proximal end (right upper end in the Figures). The injection device may be substantially cylindrical with a central longitudinal axis X extending between the distal end and the proximal end.

[0070] A cap 2 is provided on the distal end removably attached to a body 3 of the injection device 1. A needle (not shown) may be provided at the distal end of the body 3 covered by the cap 2. A cartridge containing a liquid medicament may be arranged within the body 3. The injection device 1 may comprise a dose delivery unit with a plunger which when moved distally expels the liquid medicament from the cartridge via the needle. The plunger may be driven by a spring which may be released by a trigger or button. In the depicted example, a window 4 is provided in the body 3 through which an indicator is visible which may move distally during expulsion of the medicament. For example, the injection device 1 may be an auto injector device having a general working principle as described e.g. in EP 3 122 400 B1.

[0071] Figure 1A shows an additional cap removal aid 10 configured to be attached to the cap 2 of the injection device 1 by means of a permanent or releasable connection, e.g. a click connection. As shown in Figures 1A, 1C and 1 D, the cap 2 is provided with a central opening 5 at its distal end. The cap removal aid 10 comprises an attachment portion suitable for attaching the cap removal aid 10 to the cap 2 and an operating portion suitable to be gripped by a user. The attachment portion may comprise an elastically deformable mushroom head 11 (Figure 1C) configured to be inserted into the opening 5 of the cap 2 such that the attachment portion may be pushed in and pulled out to re-use or to dispose the cap removal aid 10 after use. As an alternative, the attachment portion comprises a threaded portion 12 (Figure 1 D) configured to be screwed into the opening 5 of the cap 2 or to be pushed into the opening 5 which may also have a threaded portion and screwed out.

[0072] In the depicted examples, the operating portion comprises a ring 13. When attached to the cap 2, the ring 13 of the cap removal aid 10 has its opening arranged such that a center axis of the opening extends substantially perpendicular to the longitudinal axis X of the device 1. The ring 13 has an opening diameter between 1.5 cm and 5 cm, preferably between 2 cm and 3 cm, for example about 2.5 cm.

[0073] Although not depicted in the Figures, the cap removal aid 10 may further comprise an electronic dose recording system configured for determining, storing and / or transmitting data indicative of at least a condition of the drug delivery device or its use. For example, the electronic dose recording system may be configured to detect removal of the cap 2 from the body 3 which is indicative of an injection event.

[0074] In the example depicted in Figures 2A to 2C, a dove-tail and groove connection is provided between the cap 2 and the cap removal aid 10. The attachment portion of the cap removal aid 10 comprises a web with lateral, i.e. radially extending, protrusions 14 configured to be inserted into a groove 6 of the cap 2. A snap hook or a clamping section may be provided to prevent that the protrusions 14 unintentionally slides out of the groove 6. Figure 2C depicts a further alternative with a second ring element 7 assembled to the proximal end of the body 3.

[0075] In Figures 3A and 3B, a pin connection is provided to retain the cap removal aid 10 on the cap 2. The cap 2 is provided with at least one, in the depicted example two, pin(s) 8 extending radially from the cap 2. The cap removal aid 10 comprises an attachment portion with short sleeve 15 dimensioned to be put on the cap 2. In the depicted example, there are two webs each carrying a ring 13 arranged on opposite lateral sides of sleeve 15. The cap removal aid 10 may be made of an elastically deformable material, e.g. polypropylene, permitting deflection of the webs such that the pins 8 are allowed to engage in holes in the webs as shown in Figure 3B. As an alternative, the webs may be provided with slide in ramps 16 supported by an elastically deformable exposed area.

[0076] In a further alternative, the cap 2 may be provided with a radially protruding flange 9 or collar as shown in Figures 4A, 4B, 5A, 5B, 5C and 5D. In Figures 4A, 4B, the cap removal aid 10 is simply a ring 13 which may be put over the cap 2 until an inner edge of the ring 13 which forms the attachment portion of the cap removal aid 10 abuts the flange 9. The ring 13 also provides a finger flange being the operating portion of the cap removal aid 10.

[0077] In Figures 4C and 4D, a sleeve 15 with lateral rings 13 is put over the cap 2 until an inner edge of the sleeve 15 which forms the attachment portion of the cap removal aid 10 abuts the flange 9. Figures 4C and 4D differ in the orientation of the rings 13 in that the rings 13 depicted in Figure 4C have an opening substantially parallel to the longitudinal axis X whereas in Figure 4D the rings are arranged with the openings substantially perpendicular to the longitudinal axis X.

[0078] While the flange 9 is not located at the most distal end of cap 2 in Figures 4A to 4D, Figures 5A to 5D depict examples of a cap 2 having the flange 9 located at the most distal end. The attachment portion of the cap removal aid 10 comprises a guide channel 17 with a groove 18 configured to receive and clamp the flange 9 when the cap removal aid 10 is attached to the cap 2. In the examples of Figures 5A to 5D the cap removal aid 10 is attached in a direction substantially perpendicular to the longitudinal axis X of the injection device 1. Again, a clamping surface on the cap collar or flange 9 may retain the cap removal aid 10 on the cap 2. In Figures 5A and 5B the flange 9 is substantially rectangular in cross section, whereas in Figures 5C and 5D the flange is rounded. Figures 6A to 6C depict an alternative which is similar to the example of Figures 3A to 3C. A sleeve 15 is provided as the attachment portion of the cap removal aid 10. In this example, only one pin 8 is provided and the cap removal aid 10 comprises only one ring 13 arranged on a lateral side of sleeve 15. Figure 6B shows the cap removal aid 10 in a pre-assembled storing position which is proximally retracted compared to a more distal actuation position shown in Figure 6C. In the storing position, the overall length of the injection device 1 and the cap removal aid 10 is reduced.

[0079] Figures 7A and 7B depict an example in which the cap removal aid 10 is permanently attached to the cap 2. The cap 2 is provided with a pin 8 arranged on a web at the distal end of the cap 2. The pin 8 acts as a bearing pin for a swivel bearing 19 of the cap removal aid 10. The swivel bearing 19 is the attachment portion and the at ring 13 can be swiveled from a storing position in which the ring 13 is concentrically arranged with respect to the longitudinal axis X (Figure 7A) and an actuation position in which the ring 13 is arranged parallel to the longitudinal axis X (Figure 7B). This example has the advantage of a reduced packaging size if the ring 13 is in its storing position.

[0080] In Figures 8A to 8C the cap 2 of the injection device 1 is closed on one end by a cap lid which may be removed as show in Figure 8B. The cap removal aid 10 comprises as the attachment portion a cap lid 20 having a snap-in interface configured to close and to attach to the cap 2 of an injection device 1. In other words, the cap removal aid 10 with its ring 13 is intended to replace the original cap lid of the cap 2.

[0081] Reference Numerals

[0082] 1 injection device

[0083] 2 body

[0084] 3 cap

[0085] 4 window

[0086] 5 opening

[0087] 6 groove

[0088] 7 ring

[0089] 8 pin

[0090] 9 flange

[0091] 10 cap removal aid

[0092] 11 mushroom head

[0093] 12 threaded portion

[0094] 13 ring

[0095] 14 protrusion

[0096] 15 sleeve

[0097] 16 slide in ramp

[0098] 17 guide channel

[0099] 18 groove

[0100] 19 swivel bearing

[0101] 20 cap lid

[0102] X longitudinal axis (injection device)

Claims

Claims1. A cap removal aid (10) for an injection device (1), which injection device (1) comprises a removable cap (2) and a body (3) having a distal injection end with a needle and an opposite proximal end and defining a longitudinal axis (X), wherein the removable cap (2) is configured for encasing the needle at least partially, wherein the cap removal aid (10) comprises an attachment portion suitable for attaching the cap removal aid (10) to the cap (2) of an injection device (1) and an operating portion suitable to be gripped by a user, wherein the operating portion comprises at least one ring (13).

2. The cap removal aid (10) according to claim 1 , wherein the at least one ring (13) has an opening diameter between 1.5 cm and 5 cm, preferably between 2 cm and 3 cm.

3. The cap removal aid (10) according to anyone of the proceeding claims, further comprising an electronic dose recording system configured for determining, storing and / or transmitting data indicative of at least a condition of the drug delivery device or its use.

4. The cap removal aid (10) according to anyone of claims 1 to 3, wherein the attachment portion comprises at least one elastically deformable mushroom head (11) configured to be inserted into an opening (5) of the cap (2) of an injection device and / or at least one threaded portion (12) configured to be screwed into an opening (5) of the cap (2) of an injection device.

5. The cap removal aid (10) according to anyone of claims 1 to 3, wherein the attachment portion comprises a web with lateral protrusions (14) configured to be inserted into a groove (6) of the cap (2) of an injection device.

6. The cap removal aid (10) according to anyone of claims 1 to 3, wherein the attachment portion comprises a sleeve (15) configured to encase at least a portion of the cap (2) concentrically with the longitudinal axis (X).

7. The cap removal aid (10) according to claim 6, wherein the sleeve (15) is configured to engage at least one pin (8) or a flange (9) of the cap (2) of an injection device and wherein the operating portion comprises at least one ring (13) arranged laterally offset from the sleeve (15).

8. The cap removal aid (10) according to claim 6 or 7, wherein the attachment portion comprises a slide in ramp (16) supported by an elastically deformable exposed area.

9. The cap removal aid (10) according to anyone of claims 1 to 3, wherein the attachment portion comprises a guide channel (17) with an internal groove (18) configured to receive a flange (9) or lateral protrusion of the cap (2) of an injection device.

10. The cap removal aid (10) according to claim 9, wherein the guide channel (17) comprises a rounded clamping surface and / or a snap hook.

11. The cap removal aid (10) according to anyone of claims 1 to 3, wherein the attachment portion comprises a swivel bearing (19) configured to receive a bearing pin (8) of the cap (2) of an injection device such that the at least one ring (13) can be swiveled from a storing position in which the ring (13) is concentrically arranged with respect to the longitudinal axis (X) and an actuation position in which the ring (13) is arranged parallel to the longitudinal axis (X).

12. The cap removal aid (10) according to anyone of claims 1 to 3, wherein the attachment portion comprises a cap lid (20) having a snap-in interface configured to close and to attach to the cap (2) of an injection device.

13. An assembly comprising a injection device (1) and a cap removal aid (10) according to any one of the preceding claims configured for attachment to the injection device (1), wherein the injection device comprises:• a body (3) having a distal injection end with a needle and an opposite proximal end and defining a longitudinal axis (X),• a removable cap (2) configured for encasing the distal end and / or the needle at least partially,• a container received in the body (3) and configured to receive a drug or a cartridge filled with a drug, and• a dose delivery unit comprising a plunger configured to be axially moved with respect to the container parallel to the longitudinal axis (X), characterized in that the cap (2) of the injection device (1) comprises a mounting section, and in that the attachment portion of the cap removal aid (10) is attached to the mounting section of the cap (2) of the injection device (1).

14. The assembly according to claim 14, wherein the mounting section of the cap (2) comprises at least one of an opening (5), a groove (6), a laterally protruding pin (8), a lateral protrusion and a flange (9).

15. The assembly according to claim 13 or 14, further comprising a ring (7) at the proximal end of the body (3).

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