WO2014029725A1 - Mécanisme de commande pour un dispositif d'administration de médicament ayant un levier pivotant - Google Patents

Mécanisme de commande pour un dispositif d'administration de médicament ayant un levier pivotant Download PDF

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Publication number
WO2014029725A1
WO2014029725A1 PCT/EP2013/067223 EP2013067223W WO2014029725A1 WO 2014029725 A1 WO2014029725 A1 WO 2014029725A1 EP 2013067223 W EP2013067223 W EP 2013067223W WO 2014029725 A1 WO2014029725 A1 WO 2014029725A1
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WO
WIPO (PCT)
Prior art keywords
piston rod
lever
drive mechanism
cartridge
mechanism according
Prior art date
Application number
PCT/EP2013/067223
Other languages
English (en)
Inventor
Axel Teucher
Michael Jugl
Original Assignee
Sanofi-Aventis Deutschland Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi-Aventis Deutschland Gmbh filed Critical Sanofi-Aventis Deutschland Gmbh
Publication of WO2014029725A1 publication Critical patent/WO2014029725A1/fr

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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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31555—Mechanically operated dose setting member by purely axial movement of dose setting member, e.g. during setting or filling of a syringe
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3156—Mechanically operated dose setting member using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31563—Mechanically operated dose setting member interacting with a displaceable stop member
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • A61M5/31581—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle
    • 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
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir

Definitions

  • the present invention relates to a drive mechanism of a drug delivery device, in particular of an injection device, such like a pen-type injector.
  • the drive mechanism has at least one pivotable or pivot-mounted lever for setting and/or dispensing of a dose of a medicament typically provided in a cartridge.
  • Drug delivery devices allowing for multiple dosing of a required dosage of a liquid medicament, such as liquid drugs, and further providing administration of the medicament to a patient, are as such well-known in the art.
  • a liquid medicament such as liquid drugs
  • Such devices have substantially the same purpose as that of an ordinary syringe. They may be designed as an injection device, e.g. as a pen-type injector.
  • Drug delivery devices of this kind have to meet a number of user specific requirements. For instance in case of those with diabetes, many users will be physically infirm and may also have impaired vision. Therefore, these devices need to be robust in construction, yet easy to use, both in terms of the manipulation of the parts and understanding by a user of its operation. Further, the dose setting must be easy and unambiguous and where the device is to be disposable rather than reusable, the device should be inexpensive to manufacture and easy to dispose. In order to meet these requirements, the number of parts and steps required to assemble the device and an overall number of material types the device is made from have to be kept to a minimum.
  • the medicament to be administered is provided in a cartridge that has a moveable piston or bung mechanically interacting with a piston rod of a drive mechanism of the drug delivery device.
  • a predefined amount of the medicament can be expelled from the cartridge.
  • Drug delivery devices of e.g. pen-injector type typically comprise a distal housing component that serves as a cartridge holder and further comprise a proximal housing component or body to engage with the distal housing component and being further adapted to accommodate a drive mechanism to operably engage with the cartridge for dispensing a predefined amount of the medicament provided therein.
  • drug delivery devices such like pen-type injectors of disposable or reusable type a needle assembly comprising a needle hub and a double-tipped injection needle is to be removably arranged on a distal dispensing end of the housing of the drug delivery device.
  • the distal end of the device may serve as a cartridge holder comprising an access opening to receive a proximally extending portion of the needle.
  • the cartridge located in the distal housing portion or cartridge holder typically comprises a pierceable seal, such like a septum being penetrable by the injection needle.
  • a user has to depress a dose button, typically located at a proximal end section of the pen housing, in an axial distal direction.
  • the dose button is to be depressed by a user's thumb while the residual fingers of the same hand grip the housing of the drug delivery device.
  • an injection force is exclusively to be derived from a user-applied driving force
  • the handling of a proximal dose button can become problematic, in particular for users suffering side effects or being otherwise handicapped to appropriately depress the dose button.
  • Document DE 10 2005 026 129 A1 discloses an injection pen having a pivot mounted lever with a driving member near a pivot axis thereof.
  • the driving member comprises a somewhat circular shaped toothed profile that meshes with a correspondingly toothed profile of a linearly displaceable driven member.
  • the driven member is threadedly engaged with a piston rod.
  • a lever-induced distally directed displacement of the driven member therefore transfers to a combined rotational and distally directed displacement of the piston rod.
  • the mutual engagement of toothed surfaces requires a very accurate and precise design and/or assembly of the respective interacting components of the drive mechanism.
  • Geometric tolerances of the inter-engaging components as well as tolerances in the process of assembly may eventually lead to malfunction or to an operational heaviness when operating the lever.
  • a meshed engagement of mutually corresponding geared or toothed surfaces in close proximity to a pivot axis comes along with comparatively high mechanical loads that are due to by the leverage-effect of the pivoting lever.
  • the drive mechanism should be robust and reliable even in a long-term use.
  • the drive mechanism and/or the respective drug delivery device should comprise a comparatively simple and low-maintenance structure.
  • the drive mechanism and the device should be cost-efficient to manufacture and to assemble.
  • a drive mechanism for a drug delivery device which is adaptable and operable for dispensing of a dose of a medicament.
  • the drive mechanism comprises an elongated body extending in an axial direction.
  • the body may be of arbitrary shape but preferably comprises a substantially cylindrical or tubular geometry.
  • the body serves as a housing to accommodate various components of the drive mechanism which interact in such a way, that a well-defined dose or amount of a medicament can be set and subsequently dispensed from a container or cartridge at least partially filled with the medicament.
  • the drive mechanism further comprises a piston rod, substantially extending in axial direction that serves to engage with a piston of a cartridge containing the medicament.
  • the piston rod is movably disposed in the elongated body in axial direction with respect to said body.
  • the piston rod is movably disposed in an axial and distal direction, hence to a dispensing end of the drive mechanism to exert a respective distally directed pressure to the piston of the cartridge.
  • the piston which is movably arranged in a barrel of the cartridge, can be accordingly displaced in distal direction, thereby expelling a pre-defined amount or dose of the medicament therefrom.
  • the proximal direction relates to the direction opposite the distal direction and faces away from the dispensing end of the drive mechanism of the drug delivery device, respectively.
  • the drive mechanism further comprises at least one lever pivotally arranged relative to the body.
  • a dispensing or injection force provided by a user of the device can be received and transferred into the drive mechanism as a driving force, which, at the end, is transferred into a distally directed displacement of the piston rod for expelling a dose of the medicament from the cartridge.
  • the interconnection between the at least one lever and the piston rod is provided by at least one lever linkage which is operably engaged with the piston rod and which is pivotally connected to the lever. By means of the lever linkage, a pivoting displacement of the lever can be effectively transferred to a desired axial displacement of the piston rod.
  • the axial displacement of the piston rod is a pure sliding motion induced by an inwardly directed pivoting of the at least one lever.
  • lever linkage By means of the lever linkage, an axially directed component of the pivoting movement of the lever can be extracted and can be selectively transferred to a respective displacement of the piston rod in a rather direct and unaltered way.
  • a direct control and feedback between the pivotally arranged lever and the piston rod can be provided.
  • mechanical forces and point loads inside the drive mechanism can be substantially reduced, thus allowing to implement rather filigree and delicate components of the drive mechanism.
  • a down-sizing of the drive mechanism may be achieved.
  • the pivot axis of the at least one lever extends in a plane substantially perpendicular to the axial direction.
  • the pivot axis may extend in tangential direction with respect to the tubular-shaped body.
  • the pivot axis of the lever may coincide with the body and may be directly arranged at or in the outer circumference of the body.
  • the body comprises a radially inwardly extending recess or a
  • the pivot axis or the mounting point of the lever may be provided on or at an outwardly, e.g. radially outwardly extending protruding portion of the body.
  • the at least one lever, which is preferably attached to the body may be pivoted between an initial state, in which the lever substantially co-aligns with the outer circumference of the body and an activated position or orientation, in which the lever is pivoted outwardly and at least partially protrudes from the body.
  • the at least one lever linkage is pivotally connected to the at least one lever at a pre-defined distance from the pivot axis.
  • a leverage effect of the lever-induced operation of the drive mechanism can be modified and controlled accordingly.
  • a proximal end of the lever linkage is pivotally connected with the at least one lever while an oppositely located distal end of the lever linkage is pivotally connected with a drive member.
  • the drive member in turn is operably engaged with the piston rod to transfer a distally directed axial displacement of the lever linkage to the piston rod.
  • the lever linkage may comprise a single rod of rather straight and elongated shape.
  • the lever linkage may also comprise a bended shape or may comprise a plurality of mutually connected and/or pivot-mounted links.
  • the drive member is at least unidirectionally axially engageable with the piston rod in order to transfer a distally directed sliding displacement of the drive member into a corresponding distally directed sliding displacement of the piston rod.
  • the drive member and/or the at least one lever linkage is axially engaged with the piston rod in such a way, that at least a distally directed component of a movement of the lever linkage can be effectively and unalteredly transferred into a corresponding distally directed displacement of the piston rod.
  • the drive member axially abuts with the piston rod to transfer a lever-induced, distally directed displacement of the drive member directly and unaltered into a corresponding, distally directed displacement of the piston rod.
  • Mutual axial abutment of the drive member and the piston rod may either take place at a single of at a plurality of pre-defined axial positions of the piston rod.
  • the piston rod at least in sections comprises a toothed outer profile with a plurality of consecutively arranged teeth.
  • the toothed profile comprises a saw-toothed shape, such that a mutual relative displacement of drive member and piston rod is allowed in one direction but is blocked or locked in the opposite direction.
  • a mutually engaging or interlocking configuration is provided when the drive member is displaced in distal direction relative to the body. Due to an interlock feature, said distal displacement of the drive member can be unalteredly transferred to a corresponding distal displacement of the piston rod.
  • the drive member comprises at least one radially inwardly extending portion to engage with at least one tooth of the piston rod.
  • the inwardly extending portion of the drive member preferably extends at a pre-defined angle inwardly and in distal direction so as to get in axial abutment configuration with a stop face of a tooth of the piston rod, which may extend in radial direction with regard to the axial elongation of the piston rod.
  • the various consecutive teeth of the toothed profile of the piston rod may each comprise a bevelled surface extending from a radial inwardly directed position towards a radially outwardly protruding position in proximal direction, thereby forming the radial stop surface between a proximal outer portion of a first tooth and a radially inwardly located portion of a consecutive second tooth located proximally from the first tooth.
  • the drive member acts as a ratchet, which is displaceable in proximal direction relative to the piston rod.
  • proximally directed displacement is typically accompanied by a flexible deformation of the inwardly extending portion of the drive member.
  • the drive member comprises a ring or an annular shape extending in a plane perpendicular to the axial direction.
  • the drive member preferably comprises a plurality of inwardly extending portions engaging with the teeth of the piston rod.
  • the drive mechanism also comprises a stop element to limit a proximally directed displacement of the drive member relative to the body. By limiting the distally directed displacement of the drive member, the maximum angle, the lever can be lifted from its initial position can be modified. Accordingly, the position of the stop element has a direct impact on the activated position of the lever. Depending on the axial position of the stop element, the activated or pivoted orientation of the at least one lever may vary accordingly.
  • the number of teeth along which the drive member can be proximally moved when displacing the lever from its initial into its activated position may vary.
  • the stop element is fixable to the body in well-defined discrete axial positions, which correspond with the size and the number of teeth of the piston rod.
  • the drive mechanism further comprises a blocking element axially fixed to the body and having at least one radially inwardly extending portion to engage with the piston rod and to impede a proximally directed displacement of the piston rod relative to the body.
  • the blocking element may comprise a similar shape and geometry compared to the drive member. It may comprise a ring-like or annular shape and may entirely surround the toothed piston rod.
  • the blocking element may also comprise inwardly extending slanted portions to engage with a stop face of consecutive teeth of the piston rod. However and in contrast to the drive member the blocking element is axially fixed to the body.
  • the blocking element is particularly suitable for disposable drug delivery devices, when a reset of the drive mechanism, i.e. a proximally directed returning of the piston rod into an initial position should be effectively disabled.
  • the drive mechanism provides an effective means to antagonize product-counter fighting.
  • the above-described embodiment refers to a uni-directional engagement and mechanical coupling of the drive member and the piston rod to provide a ratchet-like drive mechanism.
  • the lever-operated drive mechanism and the lever linkage may also support a bidirectional and permanent coupling of at least the lever linkage with the piston rod.
  • the piston rod typically comprising a radially widened pressure foot at a distal end abuts with a piston of a cartridge positioned in a cartridge holder.
  • a cartridge holder of the drive mechanism comprises an outer threaded shaft portion which is threadedly engaged with a distally located receptacle of the body. This way, the cartridge holder as a whole can be threadedly inserted in proximal direction into the body during setting of a dose of the medicament.
  • the piston rod with its pressure foot is in direct axial abutment with the piston of the cartridge.
  • the cartridge with its piston and the piston rod operably engaged therewith experiences a correspondingly directed proximal displacement relative to the body.
  • This proximally directed displacement of the piston rod then induces an outwardly directed pivoting motion to the at least one lever linkage and the pivoting lever connected therewith.
  • the pivoting angle is directly correlated to the magnitude of the relative axial displacement between the cartridge holder and the body of the drive mechanism.
  • the pivoting lever is pivoted in an activated or outwardly pointing position, in which it can be gripped by a plurality of fingers or a palm of the hand of a user.
  • the at least one lever is pivoted back into its initial configuration, thereby inducing an opposite, distally directed displacement of the piston rod relative to the body. Since the cartridge holder and the body and/or its receptacle remain axially fixed during such a dose dispending action, the piston of the cartridge then receives a corresponding distally directed displacement, thereby expelling a pre-defined amount of the medicament from the cartridge.
  • the threaded engagement of the cartridge holder and the receptacle of the body is of self-locking type. Hence, axially directed forces between cartridge holder and body do not lead to a rotation of the cartridge holder relative to the receptacle of the body. This way, it can be ensured, that cartridge holder and body remain mutually fixed during such a lever-induced dose dispensing.
  • the piston rod which is in axial abutment with the piston of the cartridge is displaced in proximal direction in response to a further or repeated proximally directed displacement of the cartridge holder relative to the body.
  • the proximally displaced piston rod induces an outwardly directed pivoting motion to the at least one lever linkage and hence to the at least one lever. Since axial relative displacement of cartridge holder and body is achieved by a threaded engagement, cartridge holder and body can be axially displaced in a rather continuous and stepless way.
  • the dose size can be reduced even prior to an injection procedure by screwing the cartridge holder and body in an opposite sense of rotation. This way, the size of a set dose can be arbitrarily corrected prior to a dose dispensing or injection procedure.
  • the cartridge holder further comprises a radially widened socket near its distal end.
  • the socket comprises a stop face which is intended to axially abut with a rim of the body's receptacle in a final dose position.
  • a further relative rotation of screwing of the cartridge holder into the body is effectively impeded.
  • mutual abutment of the stop face with the receptacle coincides with a configuration of the cartridge, wherein the cartridge's piston approaches a distal or outlet end of the cartridge, i.e. when the medicament contained in the cartridge is typically used up.
  • levers and lever linkages may be used.
  • two diametrically or oppositely disposed levers and respective lever linkages may be implemented and used in order to transfer lever-pivoting induced forces in a rather homogeneous and smooth way into an axial displacement of the piston rod.
  • a two-fold lever- and lever linkage-arrangement might be beneficial.
  • the drive mechanism may work and may be
  • a drug delivery device such like a pen-type injector which comprises a drive mechanism as described above.
  • the drug delivery device also comprises a cartridge being filled with a medicament.
  • the cartridge typically comprises a tubular barrel made from a vitreous or plastic material and having a pierceable seal at a distal end thereof.
  • an axially displaceable piston which seals the inner volume of the cartridge, is provided, by way of which the
  • medicament contained therein can be expelled via the distally provided seal when pierced or penetrated by an injection needle or when otherwise connected with a fluid transferring structure.
  • drug or “medicament”, as used herein, 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, atherosclerosis and/or rheumatoid arthritis, wherein in a further
  • Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin; 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-(oo-carboxyheptadecanoyl) human insulin.
  • Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H-His-Gly-Glu- Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-lle-Glu- Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
  • Exendin-4 derivatives are for example selected from the following list of compounds:
  • H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-N H2,
  • 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 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, 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 ( ⁇ 150kDa) that are also known as
  • immunoglobulins 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 intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-1 10 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 (C H ) and the variable region (V H ).
  • the constant region is essentially identical 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
  • 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.
  • 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.
  • Fig. 1 shows a first embodiment of a drive mechanism for a drug delivery device in cross section with lifted or activated levers
  • Fig. 2 illustrates the drive mechanism according to claim 1 with the levers in an initial configuration after a dose dispensing procedure
  • Fig. 3 perspectively illustrates another embodiment of a drive mechanism
  • Fig. 4 shows the embodiment according to Fig. 3 in an exploded view
  • Fig. 5 illustrates a perspective view of the drive mechanism with a partially removed body
  • Fig. 6 shows the device according to Fig. 5 in longitudinal cross section
  • Fig. 7 perspectively illustrates the drive mechanism during a dose setting procedure
  • Fig. 8 shows the device according to Fig. 7 in longitudinal cross section
  • Fig. 9 shows a longitudinal cross section of the device according to Fig. 8 after dose dispensing
  • Fig. 10 shows the configuration of the device with a cartridge holder in a last dose position
  • Fig. 1 1 shows the device configuration according to Fig. 10 in a longitudinal cross
  • Fig. 12 is illustrative of a final configuration of the drive mechanism after dispensing of a last or final dose from a cartridge.
  • Fig. 1 is illustrative of a drive mechanism of a drug delivery device 10 comprising a tubular shaped body 12. Inside the elongated body, which extends in an axial direction, which is characterized by a distal direction 1 and an opposite proximal direction 2, a piston rod 36 is disposed. The piston rod 36 is adapted to engage with a piston 1 14 of a cartridge 1 12 filled with a medicament to be dispensed. Figs. 4 to 12. With the embodiment according to Figs. 1 and 2, a cartridge 1 12 is to be axially secured relative to the body 12. The drive mechanism as shown in Figs.
  • the levers 16 are substantially symmetrically shaped and comprise a stopper 18, preferably of polymeric or elastic material, by way of which a defined abutment with the outer circumference of the body 12 can be realized, as shown in Fig. 2.
  • the levers 16 comprise a substantially straight and elongated shape but may also comprise a bended or curved shape, which might be advantageous from an ergonomic point of view.
  • a lever linkage 20 is pivotally arranged and connected to the respective lever 16.
  • a respective pivot axis 22 extends
  • lever linkage 20 With its opposite end, the lever linkage 20 is pivot mounted and pivotally connected with a drive member 48. Also there, the pivot axis 24 by way of which the lever linkage 20 and the drive member 48 are pivotally interconnected may extend substantially parallel to the pivot axis 14 and/or to the pivot axis 22.
  • the drive member 48 which may either comprise a plurality of separate elements or which may comprise a ring substantially surrounding the piston rod 36 is axially displaceable with respect to the body 12. Such axial displacement of the drive member 48 in either distal direction 1 or proximal direction 2 can be governed and is typically accompanied by a respective pivoting of the lever and/or of the lever linkage.
  • the body 12 comprises a recessed portion or a through opening 26, e.g. in form of a longitudinal slit, through which the lever linkage 20 extends from the outside located lever 16 into the body 12.
  • a distally directed displacement of the drive member 48 can be induced by lifting the outer levers 16 from their initial configuration as shown in Fig. 2 into a lifted or activated configuration according to Fig. 1 . Since the pivot axis 14 of the lever 16 is arranged proximal compared to a distal free end of the lever 16, lifting of the lever 16 is accompanied by a respective outwardly and proximally directed displacement, hence a combined rotational and longitudinal displacement of the lever linkage 20. Since the drive member 48 is somewhat restrained-guided inside the body, only the proximally directed component of the movement of the lever linkage 20 is transferred into a linear movement of the drive member 48.
  • the drive member 48 which may resemble a ratchet disc, further comprises radially inwardly and distally pointing protrusions 50, which engage with consecutive teeth 38 of the piston rod 36.
  • a blocking element 28 at a distal end section of the body 12.
  • the blocking element 28 may comprise a similar or even identical shape and geometry compared to the drive member 48.
  • the blocking element 28 is axially fixed to the body 12.
  • both components, the blocking element 28 and the drive member 48 may be designed and may comprise a kind of a ratchet nut.
  • the various teeth 38 of the piston rod 36 comprise a saw-toothed profile.
  • each tooth 38 comprises a bevelled or slanted side face 40 or shank, which extends from distal 1 to proximal direction 2 radially outwardly.
  • a socket portion having a radially inwardly extended stop face 42.
  • a distal and radially inwardly extended portion of the protrusions 30, 50 of the blocking element 28 and the drive member 48 engage with the stop face 42 of a particular tooth 38. Since the blocking element 28 is axially fixed to the body 12, a proximally directed displacement of the piston rod 36 relative to the body 12 is substantially blocked and impeded.
  • the drive member 48 however may be displaced in proximal direction 2 with regard to both, the body 12 and the uni-directionally fixed piston rod 36. Such proximally directed displacement of the drive member 48 can be achieved by lifting the outer levers 16 from their initial configuration according to Fig. 2 to their lifted configuration according to Fig. 1 .
  • a proximally directed displacement of the drive member 48 the radially inwardly and distally extending protrusions 50 thereof mesh with consecutive teeth 38 of the piston rod 36, which cannot move in proximal direction 2 due to the engagement with the blocking element 28.
  • a user may apply radially inwardly directed pressure to at least one or to both radially protruding levers 16. This way, the drive member 48 being uni-directionally engaged with the piston rod 36 induces a correspondingly directed distal displacement of the piston rod 36 relative to the body 12.
  • the piston rod 36 can be driven in distal direction 1 , thereby exerting a respective distally directed pressure to a piston 1 14 of a cartridge 1 12 for expelling the medicament therefrom.
  • the ratchet-like mutual engagement of the piston rod 36 with the drive member 48 and/or with the blocking element 28 allows to dispense discrete amounts of the medicament wherein the various discrete steps correlate with the axial size of the teeth 38 of the piston rod 36.
  • the drive mechanism according to Figs. 1 and 2 also comprises a stop element 44, which may comprise a sleeve-like or tubular shape.
  • the stop element 44 is disposed proximal to the drive member 48 and serves as a limiting element for the axiall displacement of the drive member 48.
  • the stop element 44 comprises a distally located stop face 46, which, in the configuration according to Fig. 1 abuts with a proximal stop face 52 of the drive member 48.
  • the stop element 44 may therefore serve as a maximum dose limiting feature.
  • the stop element 44 may be displaceably arranged at various axial positions in the body 12. This way, the maximum dose to be set with the present drive mechanism can be varied. However, such axial variations of the stop element should only be conducted by authorized staff or by trained customer service but not by the patient or user of the device himself.
  • the drive mechanism and the device 10 as indicated by Figs. 1 and 2 is particularly adaptable for repeatedly or regularly dispensing doses of equal size.
  • this embodiment is suitable for a fixed dose drug delivery device, such like a fixed-dose pen- type injector.
  • the embodiment according to Figs. 3 to 12 differs from the drive mechanism according to Figs. 1 and 2 in that oppositely located levers 1 16 are permanently and non-releasably connected to a piston rod 136.
  • the device 100 or its drive mechanism as illustrated in Fig. 3 comprises a body 102, a distally located grip 1 10 as well as a cartridge holder 104 mounted at a distal end of the body 102.
  • the cartridge holder 104 serves to receive a tubular shaped cartridge 1 12 having a piston 1 14 slidably disposed therein and sealing the interior volume of the cartridge 1 12.
  • a cartridge which may comprise a vial or a carpule further comprises a pierceable seal or a septum 1 13 as indicated in Fig. 6.
  • the distally located head of the cartridge 1 12 is located inside a stepped down and threaded neck portion or socket 108 of the cartridge holder 104.
  • the outer thread of the socket 108 is adapted to threadedly receive a correspondingly shaped needle assembly having a needle hub with a corresponding and mating inner thread and further having a double- tipped needle, which by assembly of the needle assembly onto the threaded socket 108 penetrates the septum 1 13, thereby gaining access to the inner volume of the cartridge 1 12.
  • the cartridge holder 104 comprises a threaded shaft 106 which is threadedly engaged with a receptacle 134 of the body 102.
  • the entire cartridge holder 104 with the cartridge 1 12 assembled therein can be screwed into the body 102 as becomes apparent from a comparison of e.g. Fig. 5 and Fig. 10.
  • the piston rod 136 having a distally located pressure foot 139 and being in direct abutment with the proximal end face of the piston 1 14 of the cartridge 1 12 experiences a proximally directed displacement as illustrated in Fig. 7 when the cartridge holder 104 is screwed into the body 102 in proximal direction 2.
  • the piston rod 136 comprises an axially extending pin or head at its proximal end as illustrated in Fig. 4.
  • the piston rod can be axially engaged with a drive member 122, such that the piston rod 136 during a dose setting and during a screwing motion of the cartridge holder 104 relative to the body 102 may freely rotate with respect to its longitudinal axis in the drive member 122.
  • the drive member 122 further comprises radially extending lobes 132 that form a hinge-like interconnection with a lever linkage 120.
  • the lever linkage 120 is pivot mounted to the drive member 122 with a distal end portion.
  • the lever linkage 120 is pivotally connected with a proximal end portion of the lever 1 16.
  • the oppositely located levers 1 16 comprise radially inwardly extending support structures 146 that form a hinge-joint with the proximal end of the two lever linkages 120.
  • the outer levers 1 16 are pivotally connected to the receptacle 134 which comprises an annular structure with diametrically oppositely disposed radially outwardly extending protruding portions 132.
  • the levers 16 comprise a correspondingly shaped bracket 130 at their distal end to mate and to receive these protrusions 132.
  • the levers 1 16 are hinge-joint with the receptacle structure 134.
  • the body 102 comprises an upper cover 1 18 and a lower cover 1 19.
  • the two covers 1 18, 1 19 comprise a number of through openings 140 at their distally located edge, by way of which the two covers 1 18, 1 19 can be assembled with correspondingly shaped protruding pins 138 provided around the outer circumference of the receptacle structure 134.
  • the oppositely disposed support structures 146 are directly mutually interconnected via a tension spring element 142, which in the event of a dose setting procedure provides a radially inwardly directed counter force to keep the oppositely disposed levers 1 16 in a well-defined configuration.
  • lever linkages 120 are slightly tilted or slanted and extend somewhat radially outwardly in proximal direction, a proximally directed displacement of the piston rod 136 will lead to a respective spreading of the lever linkages 120, thereby pivoting the outer levers 1 16 from their initial
  • a user may apply radially inwardly directed forces or pressure to the oppositely disposed levers 1 16, thereby inducing a distally directed displacement of the piston rod 136 relative to the receptacle 134 and relative to the cartridge holder 104.
  • the threaded engagement of the threaded shaft 106 of the cartridge holder 104 and the receptacle 134 of the body 102 is of self-locking type.
  • applying a distally directed force to the piston 1 14, cartridge 1 12 and consequently onto the cartridge holder 104 does not lead to a rotative counter-directional displacement of cartridge holder 104 and body 102, respectively.
  • the threaded shaft 106 of the cartridge holder 104 terminates at a proximally facing stop face 144 adjacent a gripping structure of the cartridge holder 104.
  • the stop face 144 is adapted to engage with the outer rim of the receptacle 134 when a last dose configuration, as illustrated in Fig. 10, is reached. Once the stop face 144 abuts with the receptacle structure 134 and/or with the body 102, a further proximally directed displacement of the cartridge holder 104 relative to the body 102 and/or relative to the receptacle 134 is no longer given.
  • this last dose configuration coincides with a position of the piston 1 14 close to a distal head- or outlet portion of the cartridge 1 12.
  • the levers 1 16 cannot be pivoted any further radially outwardly.
  • a final or terminal configuration of the drug delivery device 100 can be attained in Fig. 12.
  • the piston 1 14 is near a distal outlet of the cartridge 1 12 and the medicament disposed in the cartridge 1 12 may have been almost completely dispensed from the cartridge 1 12.

Abstract

La présente invention concerne l'administration de médicament et un mécanisme de commande pour un tel dispositif d'administration de médicament pour administrer une dose d'un médicament. Le mécanisme de commande comprend : un corps allongé (12 ; 102) s'étendant dans une direction axiale (1, 2), une tige de piston (36 ; 136) destinée à venir en prise avec un piston (114) d'une cartouche (112) contenant le médicament et étant disposée de façon mobile dans la direction axiale (1, 2) par rapport au corps (12, 102), au moins un levier (16 ; 126) agencé de façon pivotante par rapport au corps (12 ; 102), et au moins une liaison mécanique de levier (20 ; 120) en prise de façon fonctionnelle avec la tige de piston (36 ; 136) et reliée de façon pivotante au levier (16 ; 126) pour transférer un déplacement pivotant du levier (16 ; 126) dans un déplacement axial de la tige de piston (36 ; 136).
PCT/EP2013/067223 2012-08-20 2013-08-19 Mécanisme de commande pour un dispositif d'administration de médicament ayant un levier pivotant WO2014029725A1 (fr)

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EP12180963 2012-08-20
EP12180963.6 2012-08-20

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WO2017114612A1 (fr) * 2015-12-30 2017-07-06 Carebay Europe Ltd Dispositif d'administration de médicament
WO2019016345A1 (fr) * 2017-07-21 2019-01-24 Becton Dickinson France Dispositif d'injection assisté pour l'injection d'une composition contenue dans un récipient médical

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EP0080793A1 (fr) * 1981-11-12 1983-06-08 John Joseph Jacklich Seringue dentaire
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EP0080793A1 (fr) * 1981-11-12 1983-06-08 John Joseph Jacklich Seringue dentaire
WO2000069488A2 (fr) * 1999-05-12 2000-11-23 Pharmacia Ab Dispositif d'injection et son mode de fonctionnement
EP1714667A1 (fr) * 2005-04-20 2006-10-25 Medisize Schweiz AG Système de dosage avec un gouteur ou pulvérisateur et deux bras articulés et la méthode de fabrication
WO2006130098A1 (fr) * 2005-06-01 2006-12-07 Shl Medical Ab Administrateur de doses posologiques
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Publication number Priority date Publication date Assignee Title
WO2017114612A1 (fr) * 2015-12-30 2017-07-06 Carebay Europe Ltd Dispositif d'administration de médicament
US11400228B2 (en) 2015-12-30 2022-08-02 Shl Medical Ag Medicament delivery device
WO2019016345A1 (fr) * 2017-07-21 2019-01-24 Becton Dickinson France Dispositif d'injection assisté pour l'injection d'une composition contenue dans un récipient médical
CN111032124A (zh) * 2017-07-21 2020-04-17 贝克顿迪金森法国公司 用于注射容纳在医疗容器中的组合物的辅助注射装置
CN111032124B (zh) * 2017-07-21 2022-03-15 贝克顿迪金森法国公司 用于注射容纳在医疗容器中的组合物的辅助注射装置
US11534549B2 (en) 2017-07-21 2022-12-27 Becton Dickinson France Assisted injection device for injecting a composition contained in a medical container

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