Reusable drug delivery device

Abstract

The present disclosure relates to a drug delivery device (20) for dispensing a fluid from a container () with flexible side walls, e.g. a BFS container. The drug delivery device (20) comprises a body (12) configured for receiving and retaining at least one container (10) with a flexible side wall, a plunger (22) movable relative to the body (21), and at least one actuator (23) arranged in the body (21) and coupled to the plunger (22) such that the at least one actuator (23) is moved relative to the flexible side wall of the container (10) if the plunger (22) is moved relative to the body (21).The at least one actuator (23) is preferably coupled to the plunger (22) by means of a geared interface (26, 27, 28) and the actuator (23) may be moved towards the flexible side wall of the container (10) if the plunger (22) is moved relative to the body (21).

Description

[0001] SANOFI PAT25025

[0002] Description

[0003] REUSABLE DRUG DELIVERY DEVICE

[0004] The present disclosure is generally directed to improvements in a reusable drug delivery device, in particular to improvements in a drug delivery device suitable for injection of a fluid from a flexible liquid container.

[0005] There is a need for reliably working drug delivery devices for administering drugs, e.g. vaccines, at reasonable costs. Pre-filled, single-use injection devices manufactured as a so-called blow-fill-seal (BFS) container are known to dispense a small dose of a drug by manually squeezing the flexible container which may be provided with a threaded interface for attaching an injection needle. For some applications, it may be difficult to dispense a drug from these containers and some users prefer a syringe-type operation over squeezing a BFS container.

[0006] US 10,933,190 B2 discloses a fluid injector device for dispensing liquid from a BFS syringe container. The fluid injector device comprises a piston acting on the flexible BFS syringe. The flexible syringe sidewall rolls upon itself when acted upon by the piston such that an outer surface of the sidewall is folded in a radially inward direction as the piston is advanced from the proximal end to the distal end, and unfolded in a radially outward direction as the piston is retracted from the distal end to the proximal end. Other examples of flexible BFS containers which can be dispensed by an axially acting deformation force of a drug delivery device are known from WO 2023 / 049213 A1 or WO 2022 / 269651 A1.

[0007] Further, WO 2016 / 168137 A1 discloses a drug delivery device comprising a flexible container, e.g. a BFS container, capable of being compressed into a single plane. The device further comprises a plunger with a pair of protrusions which are capable of compressing the drug container as the plunger moves towards the proximal end of the drug deliverydevice, by applying a force to the drug container that is perpendicular to the movement of the plunger.

[0008] Still further, WO 2022 / 135945 A1 discloses a another drug delivery device for delivering liquid from a flexible container, e.g. a BFS container, wherein the device comprises a pair of rollers driven by an actuator via a gear teeth interface. The actuator is configured to be moved linearly causing the first rollers to be translated along a housing linear gear to squeeze liquid from the flexible container. Devices with a similar working principle are described in US 2024 / 091451 A, CA 2401 388 A1 and US 2014 / 171871 A.

[0009] US 2023 / 158229 A1 discloses a gripping mechanism for clamping and retracting a portion of a rolling diaphragm syringe having a flexible sidewall.

[0010] Some of these known devices are single-use devices which have to be discarded together with the container after dispensing one dose of the drug from the container because it is not possible to replace an empty container by a new container.

[0011] It is an object of the present disclosure to provide an improved drug delivery device providing a syringe-like experience that facilitates drug delivery from a flexible container, like a blow-fill-seal (BFS) container.

[0012] This object is solved with a drug delivery device according to claim 1.

[0013] A drug delivery device according to the present disclosure is suitable for dispensing a fluid from a container with flexible side walls, especially from a blow-fill-seal (BFS) container with deformable side walls. The drug delivery device may comprise a body, a plunger and an actuator. The body may define a longitudinal axis and is configured for receiving and retaining such a container with a flexible side wall, e.g. in a compartment within the body. In an example, the body may fully encase the container with the exception of a dispensing end, e.g. a threaded outlet interface for attaching a needle. The plunger is movable relative to the body parallel to the longitudinal axis. That is, the body and the plunger may be operated like a syringe by pushing the plunger into the body. The at least one actuator is arranged within the body and may be coupled to the plungersuch that the at least one actuator is moved relative to the flexible side wall of the container upon actuation of the plunger, i.e. if the plunger is moved relative to the body parallel to the longitudinal axis.

[0014] According to an aspect of the present disclosure, the at least one actuator may be coupled to the plunger by means of a geared interface such that the at least one actuator is moved relative to the flexible side wall of the container in a direction substantially perpendicular to the longitudinal axis if the plunger is moved relative to the body parallel to the longitudinal axis. In other words, upon actuation of the plunger, i.e. pushing the plunger into the body, the actuator is moved in a direction suitable for exerting pressure on the flexible side wall(s) of the container in order to squeeze out the fluid contained in the container. The direction of movement of the actuator may be perpendicular to the longitudinal axis of the body but is not limited to a movement which is exactly perpendicular to the longitudinal axis. Rather, the direction of movement of the actuator may be along a circular path however with the direction of the movement being predominantly perpendicular to the longitudinal axis.

[0015] The drug delivery device facilitates manual injection from a BFS container. The BFS can be inserted into the body of the drug delivery device, and potentially removed after the injection. The movements of the mechanism are preferably fully reversible, i.e. the actuator may be moved away from the container by pulling the plunger out of the body, thus creating a reusable device which permits replacing an empty container by a new one. It is a benefit of the drug delivery device that the experience and feeling of a syringe during manual administration can be replicated by pressing a plunger rod with a thumb, and a grip (e.g. a flange or handle) for index and middle finger.

[0016] In an example of the present disclosure, the plunger comprises at least one linear gear meshing with at least one gear wheel operationally coupled to the at least one actuator. Thus, an axial displacement of the plunger can be translated into a clamping or squeezing movement of the actuator(s) which is substantially perpendicular to the longitudinal axis of the body. In other words, the action of pressing a plunger rod activates a mechanism of gears that squeezes the inserted BFS container which may be coupled with a needle to allow injection.Dispensing a fluid from the container by squeezing the flexible sidewall(s) of the container may be effected by providing a lever which comprises or carries the actuator. In other words, in the drug delivery device the at least one actuator may be provided on a lever which may be supported in a swivel bearing for rotation about a swivel axis which is perpendicular to the longitudinal axis. Thus, translation of the plunger may be translated into a rotation of the lever which in turn results in a movement of the actuator substantially perpendicular to the longitudinal axis and towards the sidewall of the container. For example, the at least one linear gear of the plunger meshes with at least one gear wheel which carries the lever. The action of pressing a plunger rod with its teeth activates a gear mechanism inside the body of the device. The teeth of the plunger engage with a mechanism of gears that moves levers and squeezes the inserted BFS flexible container. The mechanism activated by pressing the plunger rod is fully reversible by pulling the plunger rod back.

[0017] According to an example of the present disclosure, the drug delivery device may comprise two actuators which are moved relative to each other and relative to the flexible side wall of the container in a direction substantially perpendicular to the longitudinal axis if the plunger is moved relative to the body parallel to the longitudinal axis. In other words, the container may be squeezed interposed between the two actuators like by a pair of tongues. This may be achieved by the plunger comprising two linear gears, e.g. one on each side, each meshing with a respective gear wheel. Each gear wheel may then carry one respective lever with one actuator. As an alternative, two different gear wheels may mesh with the same linear gear of the plunger such that an additional linear gear may be omitted.

[0018] According to an alternative example of the present disclosure, the drug delivery device may further comprise a support fixed in the body such that the container is interposed between the support and the actuator. The force of the actuator squeezing the container is reacted by the support on the opposite side of the container.

[0019] An addition-al gear wheel may be provided interposed between the linear gear of the plunger and the gear wheel operationally coupled to the at least one actuator. Thisadditional gear wheel serves for moving the lever and the actuator in the direction towards the container if the plunger is pressed into the body in the case where the lever and the actuator are arranged on the same side as the linear gear of the plunger. Further, the additional gearwheel may be used to adapt the stroke of the actuator with a given stroke of the plunger, e.g. in order to increase pressing forces. As an alternative to providing an additional gear wheel, a portion of the lever and the actuator may be arranged on the opposite side of the linear gear of the plunger while the gear wheel and the swivel bearing are arranged on the same side as the linear gear of the plunger.

[0020] Operation of the drug delivery device may be facilitated by providing a radially extending flange, a handle or at least one finger ring, e.g. two rings, on the body. This allows holding the body e.g. between index finger and middle finger to provide a syringe like operation.

[0021] The container, e.g. a BFS container with a tail end, may be held in the drug delivery device. For example, the body may comprise at least one retaining clip for releasably securing the container within the body. With the container being arranged in a predetermined position within the body, the container may be held such that squeezing by means of the actuator(s) can be effected in a proper way, i.e. with the actuator(s) acting on flexible and / or collapsible portions of the container. The at least one retaining clip may be biased by a spring or the like to hold e.g. the container tail while permitting to withdraw the container from the body and the at least one retaining clip after dispensing fluid from the container.

[0022] The drug delivery device may comprise a body with an opening for introducing and / or removing the container. This opening may be provided at a distal end of the body such that the distal end of the container which may have a threaded interface for a needle may be accessible and / or protrude from the body.

[0023] Several concepts of arranging the container and / or the plunger within the body are possible. For example, the body, the plunger and the actuators with its levers may be arranged internally symmetrically. For example, the body may be configured to retain the container substantially coaxially with the plunger. As an alternative, a non-symmetricand / or off-set arrangement is possible. For example, the body may be configured to retain the container parallel to and off-set from the plunger.

[0024] In addition, further modification can be performed to have a more friendly-user reusable device, as caps for the device when it is empty, or special tweezers to remove the BSF after the injection.

[0025] The container may be filled with an, e.g. liquid, drug.

[0026] 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.

[0027] 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.

[0028] 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 leastone 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.

[0029] 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.

[0030] 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 residueoccurring 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-codea-ble, have been added to the naturally occurring peptide.

[0031] 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.

[0032] 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.

[0033] 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 (Efpegle-natide), HM-15211, CM-3, GLP-1 Eligen, ORMD-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 (Pega-pamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tir-zepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0034] 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.

[0035] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Sax-agliptin, Berberine.

[0036] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Fol litropi n, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0037] 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 (Synvisc®), a sodium hyaluronate.

[0038] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an anti-gen-binding 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 ontetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region anti-body-like binding protein having cross-over binding region orientation (CODV).

[0039] 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, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigenbinding antibody fragments are known in the art.

[0040] 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.

[0041] 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).

[0042] 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.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 of the present invention, which encompass such modifications and any and all equivalents thereof.

[0043] 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 multidose 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.

[0044] 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). 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).

[0045] In the following, non-limiting, examples of a drug delivery device are described in more detail by making reference to the drawings, in which:

[0046] Figure 1 shows a perspective view of a BFS container with a needle;Figure 2 shows a sectional view of a reusable drug delivery device according to a first example of the present disclosure;

[0047] Figure 3 shows a sectional view of a reusable drug delivery device according to a second example of the present disclosure;

[0048] Figure 4 shows a sectional view of a reusable drug delivery device according to a third example of the present disclosure; and

[0049] Figure 5 shows a sectional view of a reusable drug delivery device according to a fourth example of the present disclosure.

[0050] Figures 2 to 5 show different examples of a reusable drug delivery device suitable to dispense liquid, e.g. a drug or vaccine, from a container with flexible side walls, for example from a so-called blow-fill-seal (BFS) container 10 as depicted in Figure 1. Such a BFS container 10 comprises a reservoir 11 containing a liquid, a tail 12 and an outlet portion, which is in the depicted example a threaded interface 13 for attaching a needle 14. The reservoir 11 and its side walls are made from a thin plastic material which is deformable when applying a force, e.g. when a user squeezes the reservoir 11 as indicated in Figure 1. In other words, the liquid contained in the reservoir 11 may be dispensed by pressing on the flexible side walls of the reservoir 11.

[0051] In Figures 2 to 5 examples of drug delivery devices according to the present disclosure are shown with such a BFS container 10 without a needle attached. A drug delivery device 20 according to the present disclosure may comprise a body 21, a plunger 22 and at least one actuator 23 with a lever 24. Optionally, the drug delivery device 20 may further comprise a retaining clip 25, at least one first gear wheel 26 and, in some examples, at least one second gear wheel 27.

[0052] The body 21 may be a housing partially or fully encasing the BFS container 10, the actuator 23, the lever 24, the retaining clip 25 and the gear wheel(s) 26, 27. The body 21 may be an elongate component part with a longitudinal axis I. The plunger 22 is guidedin the body 21 and is axially movable parallel to the longitudinal axis I, i.e. the plunger 22 may be pushed further into the body 21 or may be retracted from the body 21. A linear gear 28 is provided on the plunger 22, either on both sides as shown in Figure 2 or on only one side as shown in Figures 3 to 5.

[0053] The at least one first gear wheel 26 is rotatable about a swivel bearing (not shown) with an axis extending perpendicular to the longitudinal axis I. While the example of Figure 2 comprises two first gear wheels 26, Figures 3 to 5 show examples with only one first gear wheel 26. Each first gear wheel 26 meshes with the linear gear 28 provided on the plunger 22 such that axial movement of the plunger 22 is translated into a rotation of the first gear wheel 26.

[0054] The actuator 23 may have a shape adapted to the outer contour of the reservoir 11 of the BFS container 10, especially to the flexible sidewall(s) of the reservoir 11. While the example of Figure 2 comprises two actuators 23, Figures 3 to 5 show examples with only one actuator 23. Each actuator 23 is attached to a respective lever 24 which in turn is coupled to a respective first gear wheel 26 which in turn is coupled to the linear gear 28, either indirectly via a second gear wheel 27 as in Figures 2 and 3 or directly as in Figures 4 and 5. Thus, rotation of the first gear wheel 26 causes a pivoting movement of the lever 24 and the actuator 23. The orientation and position of the actuator 23 and the lever 24 are such that the pivoting movement causes a movement of the actuator 23 which is substantially perpendicular to the longitudinal axis I as indicated by an arrow in Figures 2 to 5. In other words, the movement of the actuator is predominantly in a direction perpendicular to the longitudinal axis I and towards the side wall of the reservoir 11 if the plunger 22 is pushed into the body 21 or in a direction away from the side wall of the reservoir 11 if the plunger 22 is retracted from the body 21.

[0055] If the drug delivery device 20 comprises two actuators 23 as shown in Figure 2, the actuators 23 squeeze the reservoir 11 like a pair of tongs if the plunger 22 is pushed into the body 21. If the drug delivery device 20 comprises only one actuator 23 as shown in Figures 3 to 5, the actuator 23 pushes on the reservoir 11 and this force may be reacted either directly by the body 21 or by a support 29. Preferably, the support 29 is positioned within the body 21 such that the BFS container 10 is interposed between the support 29and the actuator 23 to squeeze out the contents of the reservoir 11 if the plunger 22 is pushed into the body 21.

[0056] The tail 12 of the container 10 may be clamped in the retaining clip 25 which comprises a pair of, e.g. spring loaded, arms for holding the container 10 in a predetermined position within the body 21. However, the container 10 may be removed from the body 21, for example through a (not shown) opening, after dispensing the contents of the reservoir 11 and replaced by a new container 10.

[0057] The body 21 may be provided with a radially protruding flange 30 (Figures 2 to 4) acting as a handle or finger rest or with one or more finger rings 31 (Figure 5). Thus, the drug delivery device 20 may be held and actuated similar to a syringe.

[0058] At least one end stop 32 for limiting the movement of the plunger 22 either in the distal direction or in the proximal direction or in both directions (as indicated in Figure 3) may be provided in the drug delivery device 20. The plunger 20 may have a corresponding flange, e.g. at its distal end as indicated in Figures 2 to 5, configured to abut the end stop 32, thereby limiting movement in one direction. In addition or alternatively, a flange of the plunger may interact with a gear wheel in order to limit the axial movement of the plunger 20.

[0059] Turning now to the different examples of Figures 2 to 5 in more detail, the internal mechanism for forcing liquid out of the reservoir 11 may be substantially symmetric as in Figure 2, or non-symmetric as in Figures 3 to 5, either with the plunger 22 substantially aligned with the longitudinal axis I as in Figures 2 to 4 or with the plunger 22 arranged off-set from the longitudinal axis I as shown in Figure 5.

[0060] The lever 24 may be straight (Figures 2, 3 or 5), curved or angled (Figure 4). The lever 24 may be permanently secured to the respective actuator 23 or may be a unitary part thereof. Further, the lever 24 may be permanently secured to the respective gearwheel 25, 26 or may be a unitary part thereof.Reference Numerals

[0061] 10 BFS container

[0062] 11 reservoir

[0063] 12 tail

[0064] 13 threaded interface 14 needle

[0065] 20 drug delivery device 21 body

[0066] 22 plunger

[0067] 23 actuator

[0068] 24 lever

[0069] 25 retaining clip

[0070] 26 first gear wheel 27 second gear wheel 28 linear gear

[0071] 29 support

[0072] 30 flange

[0073] 31 finger ring

[0074] 32 end stop

[0075] I longitudinal axis

Claims

SANOFI PAT25025Claims1. A drug delivery device for dispensing a fluid from a container (10) with flexible side walls, the drug delivery device comprising:a body (21) having a longitudinal axis (I) and being configured for receiving and retaining at least one container (10) with a flexible side wall,a plunger (22) movable relative to the body (21) parallel to the longitudinal axis (I), and at least one actuator (23) arranged in the body (21) and coupled to the plunger (22) such that the at least one actuator (23) is moved relative to the flexible side wall of the container (10) if the plunger (22) is moved relative to the body (21) parallel to the longitudinal axis (I),characterized in that the at least one actuator (23) is coupled to the plunger (22) by means of a geared interface (26, 27, 28) and in that the at least one actuator (23) is moved relative to the flexible side wall of the container (10) in a direction substantially perpendicular to the longitudinal axis (I) in order to squeeze out fluid contained in the container if the plunger (22) is moved relative to the body (21) parallel to the longitudinal axis (I).

2. The drug delivery device according to claim 1 , wherein the plunger (22) comprises at least one linear gear (28) meshing with at least one gearwheel (26, 27) operationally coupled to the at least one actuator (23).

3. The drug delivery device according to claim 1 or 2, wherein the at least one actuator (23) is provided on a lever (24) which is supported in a swivel bearing for rotation about a swivel axis which is perpendicular to the longitudinal axis (I).

4. The drug delivery device according to claims 2 and 3, wherein the at least one linear gear (28) of the plunger (22) meshes with the at least one gear wheel (26) which carries the lever (24).

5. The drug delivery device according to any one of the preceding claims comprising two actuators (23) which are moved relative to each other and relative to the flexible side wall of the container (10) in a direction substantially perpendicular to the longitudinal axis (I) if the plunger (22) is moved relative to the body (21) parallel to the longitudinal axis (I).

6. The drug delivery device according to claim 5, wherein the plunger (22) comprises two linear gears (28) each meshing with a respective gear wheel (26), wherein each gear wheel (26) carries one lever (24) with one actuator (23).

7. The drug delivery device according to any one of claims 1 to 4 further comprising a support (29) fixed in the body (21) such that the container (10) is interposed between the support (29) and the actuator (23).

8. The drug delivery device according to claim 2 and any one of claims 3 to 7, wherein an additional gear wheel (27) is provided interposed between the linear gear (28) of the plunger (22) and the gear wheel (26) operationally coupled to the at least one actuator (23).

9. The drug delivery device according to any one of the preceding claims, wherein the body (21) further comprises a flange (30), a handle or at least one finger ring (31).

10. The drug delivery device according to any one of the preceding claims further comprising at least one retaining clip (25) for releasably securing the container (10) within the body (21).

11. The drug delivery device according to any one of the preceding claims, wherein the body (21) further comprises an opening for introducing and / or removing the container (10).

12. The drug delivery device according to any one of the preceding claims, wherein the body (21) is configured to retain the container (10) coaxially with the plunger (22).

13. The drug delivery device according to any one of claims 1 to 11 , wherein the body (21) is configured to retain the container (10) parallel to and off-set from the plunger (22).

14. The drug delivery device according to any one of the preceding claims further comprising the container (10) which is filled with a drug.

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