CONTAINER RETAINING MEMBER, DRUG DELIVERY DEVICE AND METHOD

Abstract

A container retaining member including (i) a retaining member body including an inner surface that limits a retaining space for a container, in which the retaining member body has an insertion opening through which the container is insertable into the retaining space, and (ii) a fixing member is described. The fixing member includes a connecting portion that is connected to the inner surface and extends inwardly from the inner surface of the retaining member body, a first fixing portion that extends from the connecting portion into the retaining space and includes a first free end, and a second fixing portion that extends from the connecting portion or from the first fixing portion into the retaining space and comprises a second free end. The first fixing portion and the second fixing portion are arranged and configured to engage the container in order to secure the container within the container retaining member, and the first free end is arranged closer to the insertion opening than the second free end.

Claims

1.-15. (canceled)

16. A container retaining member comprising: a retaining member body comprising an inner surface that limits a retaining space for a container, wherein the retaining member body has an insertion opening through which the container is insertable into the retaining space; and a fixing member comprising: a connecting portion that is connected to the inner surface and extends inwardly from the inner surface of the retaining member body, a first fixing portion that extends from the connecting portion into the retaining space and comprises a first free end, and a second fixing portion that extends from the connecting portion and/or from the first fixing portion into the retaining space and comprises a second free end, wherein the first fixing portion and the second fixing portion are arranged and configured to engage the container in order to secure the container within the container retaining member, and wherein the first free end is arranged closer to the insertion opening than the second free end.

17. The container retaining member of claim 16, wherein the connecting portion is movably connected to the inner surface of the retaining member body, wherein the fixing member is configured such that for switching between a first state and a second state the first free end and/or the second free end move(s) axially relative to an insertion axis that is arranged crosswise or perpendicular to the insertion opening, wherein in the first state no container is inserted within the container retaining member, and wherein in the second state the container is held within the container retaining member.

18. The container retaining member of claim 17, wherein for the switching between the first state and the second state the first free end and/or the second free end move(s) away from the insertion opening.

19. The container retaining member of claim 17, wherein the fixing member is configured such that in the second state the second fixing portion extends axially relative to the insertion axis and/or that in the second state the second fixing portion is arranged at a radial position relative to the insertion axis, wherein this radial position is radially inwardly offset from the inner surface of the retaining member body.

20. The container retaining member of claim 17, wherein the fixing member is configured such that in the second state the second fixing portion is arranged between the container and the inner surface of the retaining member body.

21. The container retaining member of claim 17, wherein the first fixing portion comprises a first surface that faces in the second state axially and/or distally relative to the insertion axis.

22. The container retaining member of claim 20, wherein the first surface and the second surface include an acute angle, preferably an angle that is in the range of 30 degrees to 85 degrees or in the range of 45 degrees to 75 degrees.

23. The container retaining member of claim 17, wherein the second fixing portion comprises a second surface that in the second state faces radially and/or inwardly relative to the insertion axis.

24. The container retaining member of claim 17, wherein the first fixing portion comprises a third surface that is configured to guide the container during the insertion of the container into the retaining space, and/or wherein in the second state the third surface faces into a direction that is different from the direction in which the first surface faces and/or that is different from the direction in which the second surface faces, and/or wherein in the second state the third surface of the fixing member is located closer to the insertion opening than the first surface.

25. The container retaining member of claim 16, wherein at least one of the first free end or the second free end has a shape of a long edge or wherein at least one of the first free end or the second free end has a round shape.

26. The container retaining member of claim 16, wherein the container comprises a container main body and a container cover, and wherein the container main body comprises glass and the container cover comprises metal.

27. The container retaining member of claim 16, wherein the second fixing portion is directly connected to the first fixing portion but not directly connected to the connecting portion and wherein the first fixing portion is configured to be deformed elastically into a lateral space during an insertion of the container, especially by a cap of the container, and wherein the lateral space is bounded by the first fixing portion and/or preferably by the connection portion and by the retaining member body, or wherein the first fixing portion is directly connected to the connecting portion and the second fixing portion is directly connected to the connecting portion and wherein there is a bifurcation from which the first fixing portion and the second fixing portion extend into the retaining space in the second state and wherein the first free end and the second free end are arranged to prevent each other from losing contact to the container in the second state, especially from losing contact to a cap of the container.

28. The container retaining member of claim 16, wherein a flexible portion is arranged between the inner surface of the retaining member body and the connecting portion.

29. The container retaining member of claim 28, wherein the flexible portion comprises a film hinge, and/or wherein at least one lateral flexible connection is arranged between the first connecting portion of the first fixing member and a second connecting portion of a second fixing member.

30. The container retaining member of claim 16, wherein the retaining member body is an elongated retaining member body, and wherein the fixing member is formed unitarily with the elongated retaining member body or wherein the fixing member is formed on a separate part that is connected to the elongated retaining member body.

31. The container retaining member of claim 16, wherein the retaining member body has a length that is shorter than the width of the retaining member body or shorter than the maximum outer diameter of the retaining member body and the fixing member is formed unitarily with the retaining member body.

32. The container retaining member of claim 16, wherein the container retaining member comprises three fixing members or at least four fixing members.

33. A drug delivery device comprising: a container retaining member comprising: a retaining member body comprising an inner surface that limits a retaining space for a container, wherein the retaining member body has an insertion opening through which the container is insertable into the retaining space; and a fixing member comprising: a connecting portion that is connected to the inner surface and extends inwardly from the inner surface of the retaining member body, a first fixing portion that extends from the connecting portion into the retaining space and comprises a first free end, and a second fixing portion that extends from the connecting portion and/or from the first fixing portion into the retaining space and comprises a second free end, wherein the first fixing portion and the second fixing portion are arranged and configured to engage the container in order to secure the container within the container retaining member, and wherein the first free end is arranged closer to the insertion opening than the second free end; the container comprising a drug, wherein the container is connected to the container retaining member, wherein the fixing member is in a second state that is different from a first state in which no container is connected to the container retaining member; a main housing part that is connected to an assembly of the container retaining member and the container; and a drive mechanism being retained in the main housing part, wherein the drive mechanism is operable to dispense drug from the container.

34. A method for using a container retaining member, the method comprising: providing a container retaining member that comprises: a retaining member body comprising an inner surface and an insertion opening, wherein the inner surface limits a retaining space for a container, and a fixing member comprising: a connecting portion that is connected to the inner surface, a first fixing portion that is connected to the connecting portion and comprises a first free end, a second fixing portion that is connected to the connecting portion and/or to the first fixing portion and comprises a second free end; inserting the container through the insertion opening into the retaining space; and moving or pivoting at least a part of the fixing member or the whole fixing member when the container abuts the fixing member during the insertion of the container, whereby at least a part of the fixing member is moved from a first state to a second state by moving the first free end and/or the second free end away from the insertion opening and axially relative to an insertion axis that is arranged crosswise or perpendicular to the insertion opening.

35. The method of claim 34, wherein the second fixing portion is directly connected to the first fixing portion but not directly connected to the connecting portion and wherein the first fixing portion is configured to be deformed elastically into a lateral space during an insertion of the container, especially by a cap of the container, and wherein the lateral space is bounded by the first fixing portion and/or preferably by the connection portion and by the retaining member body, or wherein the first fixing portion is directly connected to the connecting portion and the second fixing portion is directly connected to the connecting portion and wherein there is a bifurcation from which the first fixing portion and the second fixing portion extend into the retaining space in the second state and wherein the first free end and the second free end are arranged to prevent each other from losing contact to the container in the second state, especially from losing contact to a cap of the container.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0089] For a more complete understanding of the presently disclosed concepts and the advantages thereof, reference is now made to the following description in conjunction with the accompanying drawings. The drawings are not drawn to scale.

[0090] FIG. 1 shows a first embodiment of a container retaining member in a first state.

[0091] FIG. 2 shows the container retaining member of FIG. 1 in a second state.

[0092] FIGS. 3A and 3B illustrate cross sections of a second embodiment.

[0093] FIGS. 4A, 4B and 4C illustrate cross sections of a third embodiment.

[0094] FIG. 5 illustrates a drug delivery device.

DETAILED DESCRIPTION

[0095] FIG. 1 illustrates a first embodiment of a container retaining member 100 in a first state in which no container is inserted. Container retaining member 100 may have the shape of a closed ring. Alternatively, other shapes are possible as described below.

[0096] Two fixing members 120, 121 are shown in FIG. 1. However, there are more than two fixing members 120, 121 arranged on a retaining member body 150 of the container retaining member 100. The first fixing member 120 comprises: [0097] a connecting portion 130 that is connected to retaining member body 150, [0098] a first fixing portion 132 that is connected to the connecting portion 130, and [0099] a second fixing portion 142 that is connected to the first fixing portion 132 and/or to connecting portion 130.

[0100] Alternatively both fixing portions 132 and 142 may only be directly connected to connecting portion 130.

[0101] First fixing portion 132 may comprise a first free end. Second fixing portion 142 may comprise a second free end. The container may be hold between first fixing portion 132 and second fixing portion 142 or preferably between the first free end and the second free end. Examples for the detailed design of the fixing portions are shown in FIGS. 3A to 4C. Other designs are possible as well.

[0102] Second fixing member 121 may have the same shape as the first fixing member. Both fixing members 120 and 121 may extend axially inwardly in the state that is shown in FIG. 1. This may be a first state, for instance the state after container retaining member 100 is taken out of a mold for injection molding.

[0103] Optionally, there may be flexible connections 180, 182, 184 between the fixing members 120, 121 etc. The flexible connections 180, 182, 184 may be an integral part of container retaining member 100. Flexible connections 180, 182, 184 are set more radially outward than the fixing members 120 and 121. Thus, flexible connections 180, 182, 184 may form a thin belt. Free spaces or clearances are left between the fixing members 120, 121. The fixing members 120, 121 may have a trapezoid shape that allows bending of the fixing members 120, 121 without reducing the space between fixing members 120, 121 even if the distance between them would be reduced.

[0104] An optional fold line 186 may be used that may ease the bending of fixing members 120, 121 and/or of flexible connections 180, 182, 184. Connecting portions 130 may be made thinner at the kink line 186 along a continuous line or along of short lines that have distanced areas in between where the thickness of the surrounding area is maintained. Alternatively, a perforation may be applied, i.e. through holes may be used along kink line 186, for instance elongated or circular through holes.

[0105] The comparably short and compact retaining member body 150, i.e. whole container retaining member 100, may be inserted and/or fastened into an elongated container holder that defines the retaining space for the container or that surrounds it. Alternatively, container retaining member 100 may comprise a retaining member body 150 that has an elongated shape, see for instance FIGS. 3A to 4C.

[0106] FIG. 2 illustrates the container retaining member 100 of FIG. 1 in a second state. The second state may be a state in which a container is inserted into the container retaining member 100. However, the container is not shown in FIG. 2 in order to not to obscure the relevant features. Alternatively, the state that is shown in FIG. 2 may be reached by folding the fixing members 120, 121 and/or connections 180 to 182, for instance along fold line 186, using a special tool, for instance a mandrel having a cone shape. This intermediate step may ease the insertion of the container.

[0107] In the second state, first fixing portion 132 and second fixing portion 142 may protrude to the central axis of container retaining member 100 or of retaining member body 150 that are both arranged coaxially to each other. Thus, fixing portions 132 and 134 may hold and fix the container that is inserted into an insertion opening of retaining member body 150. This is explained in more detail for other embodiments below that are shown in FIG. 3A to 4C.

[0108] FIG. 2 also shows a film hinge 190 that connects first fixing member 120 and retaining member body 150. Film hinge 190 may have a thickness within the range that is stated in the first part of this document.

[0109] FIGS. 3A and 3B illustrate cross sections along an insertion axis A of a second embodiment of a container retaining member 300 having an elongated retaining member body 302. Container retaining member 300 may be in a first state in which no container is inserted. Alternatively, container retaining member 300 may be in a second state in which a container 310 is held within container retaining member 300. Container retaining member 300 and container 310 form a container retaining assembly 301 in the second state.

[0110] Container retaining member 300 comprises: [0111] a retaining member body 302 that may have a cylindrical shape, i.e. more precisely the shape of a hollow cylinder, [0112] an inner surface 304 of retaining member body 302, [0113] an outer surface 306 of retaining member body 302.

[0114] Inner surface 304 may surround or limit a retaining space 308 that may accommodate container 310. Retaining space 308 may have the same volume like container 310, a greater volume, for instance at most 10 percent greater, or a smaller volume, for instance at most 10 percent smaller.

[0115] Container 310 may comprise: [0116] a container body 312, for instance made of glass or comprising glass, [0117] a piston 314 at one end (proximal P) of container body 312, and [0118] a container cap 318 at the other end (distal D) of container body 312.

[0119] The container cap 318 may comprise for instance a metal or may be made of metal. The container cap 318 may have a through hole through which a needle may be inserted into the inside of container 310, see FIG. 5.

[0120] Container 310 may be filled with a drug 316. The drug may comprise insulin, hormones, antibodies, one of the drugs listed on the following pages or another drug.

[0121] 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 may be used on a regular basis for chronic disorders.

[0122] 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.

[0123] 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 container 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 container 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.

[0124] 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.

[0125] 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 codeable 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.

[0126] 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, Val 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.

[0127] 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-palmitoyl 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-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0128] 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 (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide/HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, 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, TT-401, BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN and Glucagon-Xten.

[0129] An examples of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia.

[0130] Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, and Berberine.

[0131] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0132] 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.

[0133] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigen-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 on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0134] 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 antigen-binding antibody fragments are known in the art.

[0135] 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.

[0136] 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).

[0137] 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.

[0138] 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.

[0139] Furthermore with regard to FIG. 3A, container retaining member 300 may comprise an optional distal stop element 319 that may be in physical contact with a distal face of container cap 318 in the second state. A distal end D of container retaining member 300 is the end that is close to container cap 318. Furthermore, an insertion axis A is shown that extends along the longitudinal axis of container retaining member 300 and also along the longitudinal axis of retaining member body 302. A radial direction R is directed radially outwardly from insertion axis A. Container 310 is inserted along insertion axis A into retaining space 308.

[0140] Fixing members 320, 321 etc. are arranged in the distal part of container retaining member 300. An area 322 around fixing member 320 is shown in FIG. 3B in more detail, i.e. magnified.

[0141] Still referring to FIG. 3A, there is a first portion 370 of retaining space 308. First portion 370 is located between optional distal stop element 319 and fixing members 320, 321. A second portion 372 of retaining space 308 is located between fixing members 320, 321 and the proximal end P of container retaining member 300. First portion 370 is much smaller than second portion 372. The first part of this documents specifies examples for the volume of second portion 372 if compared with the overall volume of retaining space 308. Fixing members 320, 321 may be formed integrally with retaining member body 302.

[0142] However, it is also possible to place fixing members 320, 321 in the middle portion of retaining member body 302 or at the proximal end of retaining member body 302. In both cases, the container 310 may be modified, e.g. the container may have notches or recesses on respective positions that correspond to the position of the fixing members.

[0143] FIG. 3B shows a magnification of the area 322 shown in FIG. 3A. First fixing member 320 may comprise in this sequence: [0144] a connecting portion 330, [0145] a first fixing portion 332, and [0146] a second fixing portion 342.

[0147] Connecting portion 330 may be connected to retaining member body 302. First fixing portion 332 may be connected to connecting portion 330 and may further comprise a first free end 334. Second fixing portion 342 may be connected only to first fixing portion 332 and may comprise a second free end 344.

[0148] A first planar surface SF1a may be formed on first fixing portion 332 and may face into the distal direction in the second state. In the second state, surface SF1a may be perpendicular relative to insertion axis A. Surface SF1a may also have another inclination relative to the insertion axis A as described in the first part of this document. Alternatively, surface SF1a may be a concave surface or a convex surface.

[0149] A second planar surface SF2a may be formed on second fixing portion 342 and may face into a direction that is opposite to the radial direction R in the second state. In the second state, surface SF2a may be parallel relative to insertion axis A. Surface SF2a may also have another inclination relative to the insertion axis A as described in the first part of this document. Alternatively, surface SF2a may be a concave surface or a convex surface. Second fixing member 342 may have a constant thickness. Alternatively other shapes are possible.

[0150] The angle between surfaces SF1a and SF2a is 90 degree in the example. However, other angles may be useful as well. The first part of the document specifies a range for this angle too, especially a range for an acute angle.

[0151] A third planar surface SF3a may be formed on first fixing portion 332 and may face proximally in the second state. In the second state, surface SF3a may be inclined relative to insertion axis A. Surface SF3a may also have another inclination compared with the inclination shown in FIG. 3B relative to the insertion axis A. This is also described in the first part of this document in more detail. Alternatively, surface SF3a may be a concave surface or a convex surface. Third planar surface SF3a may be used to guide the cap or head of container 310 into an insertion opening 354 that is formed by fixing members 320, 321 etc.

[0152] There may be an optional free space 352 or clearance between first fixing portion 332 and retaining member body 302. Alternatively, the first fixing portion 332 may contact the retaining member body 302, i.e. without forming a free space 352 (clearance).

[0153] In an alternative embodiment, retaining member body 350 may be used instead of retaining member body 302. Retaining member body 302 may be replaced by a cylindrical container holder in this alternative embodiment. The first embodiment may be used, i.e. container retaining member 100 that comprises retaining member body 150.

[0154] No axial movement of container cap 318 and of container 310 is possible any more, i.e. neither distally D nor proximately P. It is not possible to remove container 310, especially container cap 318, out of container retaining member 400 or out of retaining member body 302 without destroying container 310 and/or some or all of fixing members 320, 321 etc. Mechanical access to fixing members 320, 321 etc. is hindered or impossible because fixing members 320, 321 are enclosed from all sides by respective parts of container retaining member 300 and or of container 310.

[0155] FIGS. 4A, 4B and 4C illustrate cross sections along an insertion axis A of a third embodiment of a container retaining member 400 and more specifically the steps of the insertion of a container into container retaining member 400. FIG. 4A shows a first state in which no container 410 is placed in a retaining space 408. FIG. 4B shows the insertion of container 410. FIG. 4C shows a second state in which container 410 is placed and fixed within container retaining member 400.

[0156] Container retaining member 400 may comprise an elongated and preferably cylindrical retaining member body 402. Retaining member body 402 may comprise: [0157] an inner surface 404, and [0158] an outer surface 406.

[0159] Inner surface 404 may surround or limit a retaining space 408 that may retain the container 410 and/or a needle 510, see FIG. 5. Container 410 may comprise a cylindrical container body 412 made for instance made of glass and a container cap 418 that may comprise for instance border crimped metal. Container 410 may be filled with the same kind of drug as container 310, see the drug list that is mentioned above.

[0160] Within container retaining member 400 and on retaining member body 402 there is a plurality of fixing members, see for instance fixing member 420 and fixing member 421 that is only shown in FIG. 4C. First fixing member 420 may comprise: [0161] a connecting portion 430, [0162] a first fixing portion 432, and [0163] a second fixing portion 442.

[0164] The other fixing members, for instance 421, may be formed in the same way as fixing member 420, i.e. all fixing members 420, 421 etc. may have the same shape. Connecting portion 430 may be connected to retaining member body 402. First fixing portion 432 may be connected to connecting portion 430 and may further comprise a first free end 434. Second fixing portion 442 may also be connected to the connecting portion 430 and/or to first fixing portion 432 and may comprise a second free end 444. Second fixing portion 442 is arranged more distally compared to first fixing portion 432 in the first state and in the second state.

[0165] Between first fixing portion 432 and second fixing portion 442 there is a clearance in which a part of container cap 418 of the container 410 may be retained, see FIG. 4C, i.e. both fixing portions 432 and 442 abut against the container 410 in the second state. Container cap 418 is arranged between first free end 434 and second free end 444. One of the free ends 434 and 444 or both free ends 434 and 444 may abut container cap 418 in the second state, i.e. may make physical contact.

[0166] In the first state, there may be a free space 452 (clearance) between pivotable fixing member 420 and inner surface 404. Alternatively, fixing member 430 may have a different inclination relative to inner surface 404 than shown in FIG. 4A in the first state.

[0167] FIGS. 4A and 4C show an insertion opening 454 that is formed by the fixing members 420, 421 etc. Container 410 is inserted into insertion opening 454 along an insertion axis A, see FIG. 4C.

[0168] FIG. 4B shows an intermediate state between first state and second state. There are the following surfaces on fixing member 420: [0169] a first surface SF1b on first fixing portion 432, [0170] a second surface SF2b on second fixing portion 442, and [0171] a third surface SF3b on first fixing portion 432.

[0172] Container 410 is inserted through the insertion opening 454 thereby guiding along the third surface SF3. A force F1 is applied to container 410 on insertion. Insertion may be done manually or automatically. A part of force F1 is used to pivot fixing member 420 to inner surface 504, i.e. to move the first fixing portion 432 and the second fixing portion 442 axially and outwardly. Thereby a force F2 is applied to fixing member 420. The same pivoting happens to the other fixing members 421, etc. that form insertion opening 454. Free space 452 may be used to retain fixing member 420 during the insertion of container cap 418 into insertion opening 454. This means that fixing member 420 may contact inner surface 404, especially the second fixing portion 442 and/or a side of the fixing member 420 that faces to inner surface 404. Alternatively, no contact is made between fixing member 420 and inner surface 404 during the insertion of container 410.

[0173] As shown in FIG. 4C, first fixing portion 432 snaps behind cap 418 when the container cap 418 is inserted further along insertion axis A distally. At the same moment, second fixing portion 442 also abuts against container cap 418. Thus both fixing portions 432 and 442 hold a part of container cap 418 and fix it in its position. Both fixing portions 432 and 442 may prevent each other from losing contact to container 410 or more specifically to container cap 418. No axial movement of container cap 418 and of container 410 is possible any more, i.e. neither distally D nor proximately P. It is not possible to remove container 410, especially container cap 418, out of container retaining member 400 or out of retaining member body 402 without destroying container 410 and/or some or all of fixing members 420, 421 etc. Mechanical access to fixing members 420, 421 etc. is hindered or impossible because they are enclosed laterally and proximally by respective parts of container retaining member 400 and/or of container 410.

[0174] First surface SF1b may be a planar surface SF1b that may face into the distal direction in the second state. In the second state, surface SF1b may be perpendicular relative to insertion axis A. Surface SF1b may also have another inclination relative to the insertion axis A as shown in FIG. 4C and as mentioned in the first part of this document. Alternatively, surface SF1b may be a concave surface or a convex surface.

[0175] Second surface SF2b may be a planar surface SF2b and may face into a direction that is opposite to the radial direction R in the second state. In the second state, surface SF2b may be parallel relative to insertion axis A. Surface SF2b may also have another inclination relative to the insertion axis A as shown in FIG. 4C and as described in the first part of this document. Alternatively, surface SF2b may be a concave surface or a convex surface. Second fixing member 342 may have a thickness that varies depending on the distance to second free end 442. Alternatively other shapes are possible.

[0176] The angle between surfaces SF1b and SF2b may be 90 degree. However, other angles may be useful as well, especially acute angles as shown in FIG. 4C. The first part of the document specifies a range for this angle too.

[0177] Third surface SF3b may be a planar surface SF3a and may face proximally in the second state. In the second state, surface SF3b may be inclined relative to insertion axis A as shown in FIG. 4C. Surface SF3b may also have another inclination relative to the insertion axis A compared with the inclination shown in FIG. 4C. This is also described in the first part of this document in more detail. Alternatively, surface SF3b may be a concave surface or a convex surface.

[0178] Optional free space 452 or clearance between fixing member 420 and retaining member body 402 may again have a greater volume compared to the intermediate state shown in FIG. 4B. Alternatively, fixing member 420 may contact the inner surface 404 of retaining member body 402 in the second state, i.e. without forming a free space 452 (clearance). The material of fixing member 420 and/or of retaining member body 402 may have an appropriate flexibility and/or resiliency in this case without free space 352.

[0179] FIG. 5 illustrates a drug delivery device 500 that comprises a container retaining member 501 according to one of the embodiments shown in FIG. 1 to FIG. 4C. The drug delivery device 500 may comprise a main housing part 502 that houses the container retaining member 501 completely or partially and that comprises further parts of the drug delivery device 500. Alternatively the main housing part 502 may be connected to the container retaining member 501 but may not surround it and even may not surround a part of the container retaining member 501, see dashed line in FIG. 5.

[0180] Within the main housing part 502 the following may be arranged: [0181] a piston rod 504 that is adapted to move the piston of the container that is within container retaining member 501, [0182] a driving mechanism 506 for the piston rod 504. The driving mechanism 506 may comprise an energy storing element, for instance a spring, that is loaded manually or automatically, for instance during assembling of drug delivery device 500, [0183] for instance at an proximal end P, an actuating element 508 that is used for the initiation of a movement of the piston rod 504 into the container retaining member 501, whereby the driving mechanism 506 is used.

[0184] Drug delivery device 500 may be a single use or a multiple use device. Actuating element 508 may be part of a trigger mechanism that is triggered from the distal end, for instance if drug delivery device 500 is an auto injecting device.

[0185] The drug may be dispensed from the container through a needle 510 or a nozzle that is connectable and/or connected to the distal end D of the drug delivery device 500. The drug delivery device 500 may be a single use device or a multiple use device. The needle 510 may be changed before each use.

[0186] Spoken with other words a mechanism has been described for the fixation of a primary packing means, for instance a container or an ampoule.

[0187] Flexible latches (fixing members) may be embedded in the container holder (container retaining member) during primary shaping/molding. The flexible latch assembly may consist of multiple latches arranged on the inside of the container holder in a circular manner around the center of the container holder in the front section, e.g. where the needle interface is. These latches may have a certain shape so they provide a counter force during container assembly in order to be able to achieve a controlled assembly process. In the natural state (first state), these latches may have a certain clearance to the container holder's inner surface, so they can flex towards the inner surface to allow for the container to pass by so it can be placed in the correct position within the container holder during assembly (see for instance FIGS. 4A to 4C). The latches may be designed in such way that once the final position of the container within the container holder is reached, i.e. the crimp cap/top section of the container has passed the latch assembly, the latches may flip into the “lock” position by means of the material-inherent restoring force, see for instance FIG. 3B. A material-inherent restoring force is optional in the example that is shown in FIGS. 4A to 4C. Another word for “material-inherent restoring force” is “resiliency or elasticity. In this “lock” position, it may be only possible to remove the container by excessive force which leads to either deformation/breakage of the latches, or more likely but dependent on the detail design of the latches disintegration of the container. The details of the design may be thickness, latch/holder material properties and so on. This fixation mechanism may be considered “tamper proof” as it is not possible to remove the container without destruction of either latches or container. These flexible latches may also be produced as separate assemblies and may be assembled into the container holder or on the container. In this case, the container holder may be designed in a way to allow for arresting the flexible latch assembly in the required position, e.g. by means of a geometrical feature within the container holder. Alternatively, chemical fixation, for instance glue, may be used to combine container holder and flexible latch assembly.

[0188] For some applications containers may need to be fixed in a container holder so that they cannot be removed from it by usual means. Other concepts for container fixation may rely on the dimension and shape of the crimp cap and may show some weaknesses—namely the removal force level variation and the unclear status of the container cap after mechanical deformation during assembly. The dimension and shape of the crimp cap may be hard to control.

[0189] The proposed container retaining member may solve the above mentioned problems by using a flexible, yet powerful connection technique—flexible latches or flexible fixing members. A flexible member within the container holder may be used to hold the container in the neck section underneath the crimp cap. It is therefore rather independent of the crimp cap dimensions, for instance diameter and/or concentricity.

[0190] Although embodiments of the present disclosure and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes and methods described herein may be varied while remaining within the scope of the present disclosure. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the system, process, manufacture, method or steps described in the present disclosure. As one of ordinary skill in the art will readily appreciate from the disclosure of the present disclosure systems, processes, manufacture, methods or steps presently existing or to be developed later that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such systems, processes, methods or steps. Further, it is possible to combine embodiments mentioned in the first part of the description with examples of the second part of the description which relates to FIGS. 1 to 5.

LIST OF REFERENCE SIGNS

[0191] A insertion axis [0192] D distal end [0193] P proximal end [0194] R radial direction [0195] 100 container retaining member [0196] 120, 121 fixing member [0197] 130 first connecting portion [0198] 132 first fixing portion [0199] 142 second fixing portion [0200] 150 retaining member body [0201] 180, 182, 184 flexible connection [0202] 186 fold line [0203] 190 film hinge [0204] SF1a, SF1b first surface [0205] SF2a, SF2b second surface [0206] SF3a, SF3b third surface [0207] 300 container retaining member [0208] 301 assembly [0209] 302 retaining member body [0210] 304 inner surface [0211] 306 outer surface [0212] 308 retaining space [0213] 310 container [0214] 312 container body [0215] 314 piston [0216] 316 drug [0217] 318 container cap [0218] 319 distal stop element [0219] 320, 321 fixing member [0220] 322 area [0221] 330 connecting portion [0222] 332 first fixing portion [0223] 334 first free end [0224] 342 second fixing portion [0225] 344 second free end [0226] 350 retaining member body [0227] 352 free space [0228] 354 insertion opening [0229] 370 first portion [0230] 372 second portion [0231] 400 container retaining member [0232] 402 retaining member body [0233] 404 inner surface [0234] 406 outer surface [0235] 408 retaining space [0236] 410 container [0237] 412 container body [0238] 418 container cap [0239] 420, 421 fixing member [0240] 430 connecting portion [0241] 432 first fixing portion [0242] 434 first free end [0243] 442 second fixing portion [0244] 444 second free end [0245] 452 free space [0246] 454 insertion opening [0247] F1, F2 force [0248] 500 drug delivery device [0249] 501 container retaining member [0250] 502 main housing part [0251] 504 piston rod [0252] 506 driving mechanism [0253] 508 actuating element [0254] 510 needle