WO2013149979A1 - Pen-type injector - Google Patents
Pen-type injector Download PDFInfo
- Publication number
- WO2013149979A1 WO2013149979A1 PCT/EP2013/056852 EP2013056852W WO2013149979A1 WO 2013149979 A1 WO2013149979 A1 WO 2013149979A1 EP 2013056852 W EP2013056852 W EP 2013056852W WO 2013149979 A1 WO2013149979 A1 WO 2013149979A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- cartridge holder
- pen
- type injector
- lug
- exendin
- Prior art date
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- GFIJNRVAKGFPGQ-LIJARHBVSA-N leuprolide Chemical compound CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)CC1=CC=C(O)C=C1 GFIJNRVAKGFPGQ-LIJARHBVSA-N 0.000 description 1
- 229960004338 leuprorelin Drugs 0.000 description 1
- XVVOERDUTLJJHN-IAEQDCLQSA-N lixisenatide Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)[C@@H](N)CC=1N=CNC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 XVVOERDUTLJJHN-IAEQDCLQSA-N 0.000 description 1
- 108010004367 lixisenatide Proteins 0.000 description 1
- 229960001093 lixisenatide Drugs 0.000 description 1
- 208000002780 macular degeneration Diseases 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- RWHUEXWOYVBUCI-ITQXDASVSA-N nafarelin Chemical compound C([C@@H](C(=O)N[C@H](CC=1C=C2C=CC=CC2=CC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1[C@@H](CCC1)C(=O)NCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H]1NC(=O)CC1)C1=CC=C(O)C=C1 RWHUEXWOYVBUCI-ITQXDASVSA-N 0.000 description 1
- 229960002333 nafarelin Drugs 0.000 description 1
- 229940055729 papain Drugs 0.000 description 1
- 235000019834 papain Nutrition 0.000 description 1
- 229940111202 pepsin Drugs 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 238000007639 printing Methods 0.000 description 1
- 125000001500 prolyl group Chemical group [H]N1C([H])(C(=O)[*])C([H])([H])C([H])([H])C1([H])[H] 0.000 description 1
- 230000002797 proteolythic effect Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- 229960004532 somatropin Drugs 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 241001223854 teleost fish Species 0.000 description 1
- 229960003813 terlipressin Drugs 0.000 description 1
- BENFXAYNYRLAIU-QSVFAHTRSA-N terlipressin Chemical compound NCCCC[C@@H](C(=O)NCC(N)=O)NC(=O)[C@@H]1CCCN1C(=O)[C@H]1NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC=2C=CC=CC=2)NC(=O)[C@H](CC=2C=CC(O)=CC=2)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)CN)CSSC1 BENFXAYNYRLAIU-QSVFAHTRSA-N 0.000 description 1
- CIJQTPFWFXOSEO-NDMITSJXSA-J tetrasodium;(2r,3r,4s)-2-[(2r,3s,4r,5r,6s)-5-acetamido-6-[(1r,2r,3r,4r)-4-[(2r,3s,4r,5r,6r)-5-acetamido-6-[(4r,5r,6r)-2-carboxylato-4,5-dihydroxy-6-[[(1r,3r,4r,5r)-3-hydroxy-4-(sulfonatoamino)-6,8-dioxabicyclo[3.2.1]octan-2-yl]oxy]oxan-3-yl]oxy-2-(hydroxy Chemical compound [Na+].[Na+].[Na+].[Na+].O([C@@H]1[C@@H](COS(O)(=O)=O)O[C@@H]([C@@H]([C@H]1O)NC(C)=O)O[C@@H]1C(C[C@H]([C@@H]([C@H]1O)O)O[C@@H]1[C@@H](CO)O[C@H](OC2C(O[C@@H](OC3[C@@H]([C@@H](NS([O-])(=O)=O)[C@@H]4OC[C@H]3O4)O)[C@H](O)[C@H]2O)C([O-])=O)[C@H](NC(C)=O)[C@H]1C)C([O-])=O)[C@@H]1OC(C([O-])=O)=C[C@H](O)[C@H]1O CIJQTPFWFXOSEO-NDMITSJXSA-J 0.000 description 1
- 229960004824 triptorelin Drugs 0.000 description 1
- VXKHXGOKWPXYNA-PGBVPBMZSA-N triptorelin Chemical compound C([C@@H](C(=O)N[C@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)NCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)C1=CC=C(O)C=C1 VXKHXGOKWPXYNA-PGBVPBMZSA-N 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2403—Ampoule inserted into the ampoule holder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2485—Ampoule holder connected to rest of syringe
- A61M2005/2488—Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3125—Details specific display means, e.g. to indicate dose setting
- A61M2005/3126—Specific display means related to dosing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/59—Aesthetic features, e.g. distraction means to prevent fears of child patients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
Definitions
- the invention refers to a pen-type injector equipped with a cartridge holder.
- the cartridge holder has a longitudinal axis and comprises a body for receiving a car- tridge.
- the body comprises engagement means at a proximal end for releasably coupling the cartridge holder to the drug delivery device, at least one latch member for releasably engaging a cap of the drug delivery device and at least one alignment element which is visual from the outer side of the body.
- Pen-type injectors are regularly used by persons who do not have formal medical training. Accordingly, the application comes along with circumstances that set a number of requirements for drug delivery devices of this kind. In case of improper use such as unintended disassembly actions there is the risk of malfunction and contamination of the medicament stored in the cartridge.
- the device must be robust in construction in order to prevent manipulation of the components.
- the cartridge holder which is connected to the housing of the drug delivery device, there is demand for a reliable connection easy to manufacture and to assemble but also safe regarding to any kind of manipulation or malfunction.
- a cartridge holder may either be permanently attached to the drug delivery device such that the drug delivery device has to be discarded if the cartridge is empty or the drug delivery device is a reusable device which allows detaching the cartridge holder to replace an empty cartridge by a new one. In the latter case it is inevitable to ensure that the cartridge holder is fully and firmly attached to the drug delivery device after replacing an empty cartridge.
- reusable pen injectors are known in which the cartridge holder is attached to the drug delivery device mechanism by means of a helical thread or a bayonet.
- visual features on the drug delivery device and/or on the cartridge holder to assist users in determining when the cartridge hold- er is fully engaged.
- visual features are provided on the outer surfaces of both the cartridge holder and an outer housing of the drug delivery device that lineup with each other only if the cartridge holder is fully locked to the drug delivery device.
- WO 2010/037828 A1 discloses an assembly comprising a drug delivery device and a monitoring device adapted to detect an action taking place in the drug delivery device.
- the drug delivery device comprises a main portion with coupling means for a cover.
- the monitoring device comprises a housing portion, means for detecting an action taking place in the drug delivery device, and coupling means adapted to en- gage the coupling means on the main portion.
- the monitoring device can be placed in a pre-determined position relative to the main portion when the coupling means engage each other, thus allowing transmission of information between the monitoring device and the main portion.
- the cover and the monitoring device use the same coupling means for attachment on the main portion, either the cover or the monitoring device may be attached at the same time.
- the coupling means thus, has the single function of attaching on of said components.
- the invention further aims at providing a cartridge holder which is simplified with respect to the mold construction and/or the number of printing operations required in production.
- the main aspect of the invention is the use of either an aperture or a cap retaining latch member of the cartridge holder as an alignment member.
- the aperture or the cap retain- ing latch member has a double function, thus reducing the number of separate elements on the cartridge holder.
- the latch member is the alignment member and at the same time the cap retaining member, thus fulfilling two different functions independent from each other at the same time.
- the alignment of the cartridge holder to the housing may be kept either with the cap attached or detached. In other words, it is not required to misalign the cartridge holder and the housing for attaching or detaching the cap.
- the injector or drug delivery device may be a re-usable device which allows to exchange an empty cartridge by a new one.
- the present invention is based on the idea that the function of the visual alignment feature which has to be provided on the cartridge holder is combined with an aperture or window in the cartridge holder and/or a latch member or detent feature for retain- ing the cap of the drug delivery device.
- the alignment element which is visual from the outer side of the body of the cartridge holder may have the form of a lug which constitutes the latch member for releasably engaging the cap of the drug delivery device.
- the cartridge holder visual alignment feature also serves as a cap detent feature. In the assembled state of the cartridge holder and the drug delivery device, the cap may be retained on the cartridge holder by corresponding catch or snap features provided on the cartridge holder and the cap, respectively.
- the lug has a trapezoidal (blunted triangle) or triangular shape in a cross section parallel to the longitudinal axis of the cartridge holder.
- the lug may have the form of an arrow or any other form, suitable to indicate a position of the lug relative to another visual alignment feature.
- the e.g. triangular shaped lug is preferably arranged such that a tip of the lug is facing towards the proximal end of the body and a side of the triangular lug is facing towards the distal end of the body.
- the triangular shape of the lug assists users in recognizing the correct alignment condition of the cartridge holder relative to the drug delivery device.
- the lug may have a chamfered outer surface such that the height of the lug increases in the direction of the longitudinal axis of the cartridge holder from the distal end to the proximal end.
- the lug may be provided on its outer surface with a cranked region or a protrusion.
- the cartridge holder alignment feature also serves as a cartridge grip aperture.
- the cartridge grip aperture may be a hole that is intended to allow users to retain control over the location of the cartridge when fitting or removing the cartridge holder from the housing of the drug delivery device to reduce the risk that the cartridge is inadvertently dropped.
- the aperture is a long hole or a slot having a longitudinal axis which is orientated parallel to the longitudinal axis of the cartridge holder.
- the body of the cartridge holder may consist of a transparent or translucent material to allow a user to view the cartridge content.
- a hole or slot may be provided in the cartridge holder to partly expose the cartridge.
- a pen-type injector according to the present invention may have a housing, a cap and a cartridge holder, wherein the housing is provided with engagement means for re- leasably coupling the cartridge holder to the drug delivery device and with an alignment element which is arranged such that it faces the alignment element of the body if the cartridge holder is fully attached to the housing via the engagement means.
- the housing of the pen-type injector may be an outer shell of the drug delivery device encasing at least partly mechanical components of the device.
- the housing may further be an inner housing provided at least in part within the outer shell of the drug delivery device or may be an insert fixed to an inner or outer housing of the drug delivery device.
- the present invention is not limited to embodiments, where the alignment element and the engagement means are provided on a single component.
- the alignment element may be provided on an outer shell (housing) of the pen-type injector, whereas the engagement means may be provided on an inner housing or insert.
- the alignment element of the pen-type injector has an identical or at least similar form and/or color as the alignment element of the cartridge holder. This assists users in recognizing the correct alignment condition.
- the alignment element of the pen-type injector may be a protrusion, a recess or an e.g. colored marking.
- the cap is provided with an annular notch on its inner surface for receiving the latch member of the body.
- a cap may be provided as a sleeve-like element which is closed on its distal end and open on its proximal end.
- the annular notch or groove is provided in the vicinity of the proximal end.
- the engagement means for retaining the cartridge holder on the pen-type injector may comprise a helical thread or a bayonet.
- the pen-type injector is a resettable injection device allowing to detach the cartridge holder.
- the drive mechanism of the pen-type injector may further include a piston rod which can be pushed back or wound back for replacing an empty cartridge by a new one.
- a cartridge containing a medicinal product such as a medicament within the cartridge holder.
- the term ..medicament means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, , an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever
- ACS acute coronary syndrome
- Lys(B3) Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; 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.
- Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; 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-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; ⁇ 29- ⁇ -( ⁇ - carboxyheptadecanoyl)-des(B30) human insulin and B29-N-( -carboxyhepta- decanoyl) human insulin.
- Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H-His-Gly-
- Exendin-4 derivatives are for example selected from the following list of compounds:
- Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
- Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
- Somatropine Somatropin
- Desmopressin Terlipressin
- Gonadorelin Triptorelin
- Leuprorelin Buserelin
- Nafarelin Goserelin.
- a polysaccharide is for example a glucosanninoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a deriva- tive thereof, or a sulphated, 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.
- Antibodies are globular plasma proteins (-1 50 kDa) that are also known as immuno- globulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins.
- the basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.
- Ig immunoglobulin
- the Ig monomer is a "Y"-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intra- chain disulfide bonds which stabilize their folding . Each chain is composed of structural domains called Ig domains. These domains contain about 70-1 1 0 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two ⁇ sheets create a "sandwich" shape, held together by interactions between conserved cysteines and other charged amino acids.
- Ig heavy chain There are five types of mammalian Ig heavy chain denoted by ⁇ , ⁇ , ⁇ , ⁇ , and ⁇ .
- the type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
- Distinct heavy chains differ in size and composition; a and ⁇ contain approximately 450 amino acids and ⁇ approximately 500 amino acids, while ⁇ and ⁇ have approximately 550 amino acids.
- Each heavy chain has two regions, the constant region (CH) and the variable region (V H ).
- the constant region is essentially identi- cal in all antibodies of the same isotype, but differs in antibodies of different isotypes.
- Heavy chains ⁇ , a and ⁇ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains ⁇ and ⁇ have a constant region composed of four immunoglobulin domains.
- variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone.
- the variable region of each heavy chain is approximately 1 10 amino acids long and is composed of a single Ig domain.
- a light chain has two successive domains: one constant domain (CL) and one variable domain (VL).
- CL constant domain
- VL variable domain
- the approximate length of a light chain is 21 1 to 217 amino acids.
- Each antibody contains two light chains that are always identical; only one type of light chain, ⁇ or ⁇ , is present per antibody in mammals.
- variable (V) regions are responsible for binding to the antigen, i.e. for its antigen specificity.
- VL variable light
- VH variable heavy chain
- CDRs Complementarity Determining Regions
- an "antibody fragment” contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from.
- Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab).
- the Fc contains carbohydrates, complement-binding, and FcR-binding sites.
- F(ab')2 is divalent for antigen binding.
- the disulfide bond of F(ab')2 may be cleaved in order to obtain Fab'.
- the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv).
- Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
- Acid addition salts are e.g. HCI or HBr salts.
- Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1 )(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 -C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6- C10-heteroaryl group.
- solvates are for example hydrates.
- Figure 1 shows a perspective view of a housing of a cartridge holder according to a first embodiment
- Figure 2 shows a sectional view of the cartridge holder of Figure 1 together with a housing and a cap;
- Figure 3 shows a perspective view of the cartridge holder of Figure 1 together with a housing in a not fully aligned position
- Figure 4 shows a perspective view of the cartridge holder of Figure 1 together with a housing in a fully aligned position
- Figure 5 shows a perspective view of a housing of a cartridge holder according to a second embodiment.
- FIG. 1 shows a cartridge holder 1 which can be attached to a drug delivery device (not shown).
- an outer housing 2 of the drug delivery device is partly depicted together with an insert or inner housing 3 which is also part of the drug delivery device.
- Figure 2 partly shows a cap 4 attached to the cartridge holder 1 .
- the cartridge holder 1 as depicted in Figure 1 comprises a sleeve-like body 5 defining a longitudinal axis and having a proximal end 6 and a distal end 7.
- the proximal end 6 is provided with a series of bayonet lugs 8 serving as engagement means for releasably coupling the cartridge holder 1 to the inner housing 3 of the drug delivery device.
- the distal end 7 of the cartridge holder 1 is provided with a threaded section 9 for attaching a needle assembly (not shown).
- a cartridge content scale 10 may be printed on the outer surface of the body 5 which may be made from a transparent or translucent material.
- a lug 1 1 is provided on the outer surface of the body 5 near its proximal end 6.
- the lug 1 1 has the shape of a blunted triangular (trapezoidal shape) with one (blunted) tip facing towards the proximal end 6 and one side facing in the distal direction.
- lug 1 1 has an inclined outer surface which is arranged such that the distal side of lug 1 1 protrudes less from the outer surface of the body compared with the proximal tip of lug 1 1 .
- lug 1 1 has a chamfered outer surface with its height increasing from its distal end to its proximal end.
- lug 1 1 is depicted in Figures 1 , 3 and 4, there may be additional lugs 1 1 on the cartridge holder.
- two lugs 1 1 are located on opposite sides of the body 5.
- Attach- ment of cartridge holder 1 in the inner housing 3 includes a relative rotational movement component.
- cartridge holder 1 has to be twisted relative to inner housing 3, i.e. relative to the drug delivery device. This can be seen from a comparison of Figures 3 and 4 wherein Figure 3 shows a state where the cartridge holder is not yet fully attached, while Figure 4 shows a state with the cartridge holder fully attached to the drug delivery device.
- lug 1 1 serves as an alignment element.
- a corresponding alignment element 12 is provided on the outer surface of the drug delivery device (in this embodiment the outer surface of the inner housing 3).
- the corresponding alignment element 12 may have a similar form and/or color as lug 1 1 .
- alignment element 12 has a triangular shape with one tip facing in the distal direction. Thus, it is easy for a user to control whether the tips of lug 1 1 and alignment element 12 face to each other to indicate that the cartridge holder is fully attached.
- lug 1 1 has a further function of retaining a cap 4 on the cartridge holder 1 .
- cap 4 is provided with an annular notch 13 on its inner surface. Notch 13 is located such that lug 1 1 snaps into place in notch 13 if the cap 4 is fully attached to the cartridge holder 1 and thus to the drug delivery device.
- FIG 5 A further embodiment is depicted in Figure 5 showing the cartridge holder of Figure 1 from a different point of view. The upper side of cartridge holder 1 of Figure 1 with the scale 10 is the lower side of the cartridge holder in Figure 5.
- a main aspect of the embodiment of Figure 5 is an aperture 14 provided in body 5 of the cartridge holder.
- Aperture 14 may be a hole allowing users to retain control over a cartridge (not shown) which may be received within the cartridge holder. Thus, the risk that the cartridge is inadvertedly dropped when fitting or removing the cartridge holder is reduced.
- aperture 14 serves as an alignment element assisting users to recognize the correct attachment of the cartridge holder.
- the drug delivery device for example its inner housing 3 or its outer housing 2
- Figure 5 shows the second embodiment which uses an aperture 14 as alignment feature such that the general design of the cartridge holder 1 is identical or at least similar to that described above with respect to Figure 1 .
- the cartridge holder of the second embodiment may have a different form, in particular it is not neces- sary for this second embodiment that the lug(s) 1 1 for retaining the cap are triangular.
- the cap may be retained by a bead or an annular rib on the cartridge holder or by respective features provided on the housing of the drug delivery device.
- the embodiment of Figure 1 does not necessarily require an aperture 14 or the like to use the lug(s) 1 1 as an alignment feature.
Landscapes
- Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Priority Applications (14)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
RU2014144353A RU2643081C2 (ru) | 2012-04-05 | 2013-04-02 | Инъектор карандашного типа |
JP2015503845A JP6339558B2 (ja) | 2012-04-05 | 2013-04-02 | ペン型注射器 |
MX2014011994A MX363321B (es) | 2012-04-05 | 2013-04-02 | Inyector de tipo pluma. |
DK13713198.3T DK2833945T3 (da) | 2012-04-05 | 2013-04-02 | Pensprøjte |
US14/388,549 US9849245B2 (en) | 2012-04-05 | 2013-04-02 | Pen-type injector |
PL13713198T PL2833945T3 (pl) | 2012-04-05 | 2013-04-02 | Wstrzykiwacz typu „pen” |
AU2013245105A AU2013245105B2 (en) | 2012-04-05 | 2013-04-02 | Pen-type injector |
HK15101754.7A HK1201220B (en) | 2012-04-05 | 2013-04-02 | Pen-type injector |
ES13713198T ES2820513T3 (es) | 2012-04-05 | 2013-04-02 | Inyector de tipo pluma |
CN201380015710.5A CN104519928B (zh) | 2012-04-05 | 2013-04-02 | 笔型注射器 |
EP13713198.3A EP2833945B1 (en) | 2012-04-05 | 2013-04-02 | Pen-type injector |
KR1020147028981A KR102144138B1 (ko) | 2012-04-05 | 2013-04-02 | 펜형 주사기 |
BR112014024651-3A BR112014024651B1 (pt) | 2012-04-05 | 2013-04-02 | Injetor tipo caneta |
IL234609A IL234609B (en) | 2012-04-05 | 2014-09-11 | A pen-like syringe |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP12163484 | 2012-04-05 | ||
EP12163484.4 | 2012-04-05 | ||
US201261666269P | 2012-06-29 | 2012-06-29 | |
US61/666,269 | 2012-06-29 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2013149979A1 true WO2013149979A1 (en) | 2013-10-10 |
Family
ID=49300028
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2013/056852 WO2013149979A1 (en) | 2012-04-05 | 2013-04-02 | Pen-type injector |
Country Status (11)
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KR20170074968A (ko) * | 2014-10-28 | 2017-06-30 | 바이엘 헬쓰케어 엘엘씨 | 자기 배향 압력 자켓 및 압력 자켓 대 주입기 인터페이스 |
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US10512720B2 (en) | 2014-10-28 | 2019-12-24 | Bayer Healthcare Llc | Self-orienting syringe and syringe interface |
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US11191893B2 (en) | 2018-01-31 | 2021-12-07 | Bayer Healthcare Llc | System and method for syringe engagement with injector |
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AU349331S (en) * | 2012-07-05 | 2013-06-20 | Sanofi Aventis Deutschland | Injection device |
USD752211S1 (en) * | 2012-08-01 | 2016-03-22 | Sanofi-Aventis Deutschland Gmbh | Injection device |
AR092276A1 (es) | 2012-08-31 | 2015-04-08 | Sanofi Aventis Deutschland | Dispositivo de administracion de farmacos |
AU2013310949A1 (en) * | 2012-08-31 | 2015-03-12 | Sanofi-Aventis Deutschland Gmbh | Drug delivery device |
CA155282S (en) * | 2013-09-04 | 2015-02-10 | Sanofi Aventis Deutschland | Injection device |
USD752738S1 (en) * | 2013-09-20 | 2016-03-29 | Sanofi-Aventis Deutschland Gmbh | Injection device |
USD743538S1 (en) * | 2014-01-17 | 2015-11-17 | Sanofi-Aventis Deutschland Gmbh | Injection device |
USD777908S1 (en) * | 2014-08-27 | 2017-01-31 | Merck Sharp & Dohme Corp. | Medical injector pen |
USD773646S1 (en) * | 2014-08-27 | 2016-12-06 | Merck Sharp & Dohme Corp | Medical injector pen |
USD777907S1 (en) * | 2014-08-27 | 2017-01-31 | Merck Sharp & Dohme Corp. | Medical injector pen |
CN107820447B (zh) * | 2015-06-08 | 2021-07-13 | 康宁股份有限公司 | 可读性和韧性得到改善的移液管 |
CN108837238B (zh) * | 2018-07-13 | 2023-09-01 | 江苏省人民医院(南京医科大学第一附属医院) | 一种玻尿酸注射针 |
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Cited By (13)
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US10792418B2 (en) * | 2014-10-28 | 2020-10-06 | Bayer Healthcare Llc | Self-orienting pressure jacket and pressure jacket-to-injector interface |
CN107106761A (zh) * | 2014-10-28 | 2017-08-29 | 拜耳医药保健有限公司 | 自定向压力护套以及压力护套到注射器的接口 |
US20170333624A1 (en) * | 2014-10-28 | 2017-11-23 | Bayer Healthcare Llc | Self-orienting pressure jacket and pressure jacket-to-injector interface |
US10245375B2 (en) | 2014-10-28 | 2019-04-02 | Bayer Healthcare Llc | Self-orienting syringe and syringe interface |
US10512720B2 (en) | 2014-10-28 | 2019-12-24 | Bayer Healthcare Llc | Self-orienting syringe and syringe interface |
AU2015339379B2 (en) * | 2014-10-28 | 2020-09-03 | Bayer Healthcare Llc | Self-orienting pressure jacket and pressure jacket-to-injector interface |
KR20170074968A (ko) * | 2014-10-28 | 2017-06-30 | 바이엘 헬쓰케어 엘엘씨 | 자기 배향 압력 자켓 및 압력 자켓 대 주입기 인터페이스 |
CN107106761B (zh) * | 2014-10-28 | 2020-11-03 | 拜耳医药保健有限公司 | 自定向压力护套以及压力护套到注射器的接口 |
US11129934B2 (en) | 2014-10-28 | 2021-09-28 | Bayer Healthcare Llc | Self-orienting pressure jacket and pressure jacket-to-injector interface |
US11419977B2 (en) | 2014-10-28 | 2022-08-23 | Bayer Healthcare Llc | Self-orienting syringe and syringe interface |
KR102497204B1 (ko) * | 2014-10-28 | 2023-02-06 | 바이엘 헬쓰케어 엘엘씨 | 자기 배향 압력 자켓 및 압력 자켓 대 주입기 인터페이스 |
US11577022B2 (en) | 2014-10-28 | 2023-02-14 | Bayer Healthcare Llc | Self-orienting syringe and syringe interface |
US11191893B2 (en) | 2018-01-31 | 2021-12-07 | Bayer Healthcare Llc | System and method for syringe engagement with injector |
Also Published As
Publication number | Publication date |
---|---|
MX2014011994A (es) | 2014-11-10 |
RU2014144353A (ru) | 2016-05-27 |
RU2643081C2 (ru) | 2018-01-30 |
JP2015516840A (ja) | 2015-06-18 |
HK1201220A1 (en) | 2015-08-28 |
EP2833945B1 (en) | 2020-09-02 |
JP6339558B2 (ja) | 2018-06-06 |
CN104519928A (zh) | 2015-04-15 |
EP2833945A1 (en) | 2015-02-11 |
MX363321B (es) | 2019-03-20 |
KR20150003198A (ko) | 2015-01-08 |
AU2013245105A1 (en) | 2014-10-23 |
PL2833945T3 (pl) | 2021-03-08 |
BR112014024651A2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) | 2017-06-20 |
CN104519928B (zh) | 2017-09-22 |
US20150057619A1 (en) | 2015-02-26 |
AU2013245105B2 (en) | 2017-10-19 |
BR112014024651B1 (pt) | 2021-09-21 |
KR102144138B1 (ko) | 2020-08-12 |
US9849245B2 (en) | 2017-12-26 |
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