WO2009062684A1 - Système d'injection muni d'un mécanisme à encliquetage pouvant être désaccouplé - Google Patents

Système d'injection muni d'un mécanisme à encliquetage pouvant être désaccouplé Download PDF

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Publication number
WO2009062684A1
WO2009062684A1 PCT/EP2008/009542 EP2008009542W WO2009062684A1 WO 2009062684 A1 WO2009062684 A1 WO 2009062684A1 EP 2008009542 W EP2008009542 W EP 2008009542W WO 2009062684 A1 WO2009062684 A1 WO 2009062684A1
Authority
WO
WIPO (PCT)
Prior art keywords
injection device
coupling member
section
threaded portion
engagement
Prior art date
Application number
PCT/EP2008/009542
Other languages
German (de)
English (en)
Inventor
Eric Hattler
Jürg HIRSCHEL
Ulrich Moser
Markus Tschirren
Original Assignee
Tecpharma Licensing Ag
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 Tecpharma Licensing Ag filed Critical Tecpharma Licensing Ag
Priority to EP08850963A priority Critical patent/EP2219714A1/fr
Priority to CN200880124682XA priority patent/CN101909678A/zh
Publication of WO2009062684A1 publication Critical patent/WO2009062684A1/fr

Links

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
    • A61M5/31525—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
    • 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
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M2005/3152—Piston or piston-rod constructions, e.g. connection of piston with piston-rod including gearings to multiply or attenuate the piston displacing force
    • 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
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
    • 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
    • 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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31561—Mechanically operated dose setting member using freely adjustable volume steps
    • 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
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
    • 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
    • A61M5/31591—Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means

Definitions

  • the invention relates to an injection device for administering a particular liquid product, such as. B. a drug.
  • a particular liquid product such as. B. a drug.
  • insulin preparations, growth hormones, or other similar medicaments to be administered to a human or animal patient can be administered with the injection device.
  • the injection device can be distributed together or separately with a separate drug which is inserted into the injection device by the user of the injection device.
  • the injection device is distributed with a drug contained in the injection device, whereby the injection device can also be regarded as a disposable injection device, which is disposed of after complete release of the product.
  • Injection devices are known from the prior art which produce sensible or audible clicking sounds when setting a product dose. Normally, a force or torque must be applied to create a clicking sound. However, such a force or torque can make it difficult to distribute the product.
  • the injection device comprises a locking member and a coupling member.
  • the locking member can in the z. B. sleeve-shaped coupling member engage.
  • the locking member are held by a spring force in the engagement.
  • This force can be generated, for example, by a separate spring acting on the detent member or by a spring arm on which the detent member is disposed and which is rotatable and preferably axially movable on an element relative to which the coupling member is, such as, for example a housing of the injection device can be arranged.
  • the locking member is acted upon by a radially inwardly acting force, which presses the locking member into engagement with the outer periphery of the coupling member.
  • the coupling member has at its periphery, in particular at its outer periphery, at least one profile section and at least one threaded portion.
  • the profile section is designed such that - if the locking member engages in the profile section - at a relative rotation between locking member and coupling member, the locking member snaps over the profile section, with a tactile or audible click can be perceived.
  • the advantage of the latching engagement is that on the one hand an unconscious rotation of the coupling member is prevented, that is, for example, an external torque that can be applied by the hand of a user to the coupling member should act on the coupling member to make a conscious rotation of the coupling member and to overcome the resistance provided by the latching engagement.
  • the at least one profile section can also be designed such that, in the case of a relative axial displacement between the coupling member and the latching member, the latching member does not perform any latching movement. This makes it easier for the user of the device to move the coupling member.
  • the at least one profile section has a plurality of grooves extending in the longitudinal direction of the coupling member and arranged side by side in the circumferential direction. The locking member preferably engages in one of the grooves, wherein their flanks prevent undesired rotation.
  • the locking member In one, in particular conscious, rotation of the coupling member relative to the locking member, the locking member is pressed by a flank of the groove and engages in the adjacent groove, whereby the click is generated. Due to the elongated configuration of the grooves, an axial displacement of the coupling member relative to the locking member is possible without a clicking sound.
  • the flanks of the grooves and / or the locking member are preferably designed so that the locking member upon rotation of the coupling member is pushed out of the groove.
  • the radially outwardly projecting flank separating two adjacent grooves is symmetrical in cross-section to the radial axis of rotation of the coupling member.
  • flanks and / or the locking member are designed so that a rotation of the coupling member relative to the locking member in both directions of rotation is possible.
  • the applied torque for rotation of the coupling member in a first direction of rotation may be different in magnitude from the torque in the other direction of rotation.
  • the torques required for the rotation are substantially the same for both directions of rotation.
  • the at least one threaded portion of the coupling member is preferably configured such that it limits the at least one profile section, preferably in both axial directions, at least in one axial direction.
  • the at least one threaded portion extends at least partially helically over the circumference of the coupling member.
  • the at least one profile section extends helically, at least partially over the circumference of the coupling member.
  • the profile section and / or the at least one threaded section can wind multiple times or only around a part of the circumference of the coupling member.
  • the at least one profile section and / or the at least one threaded section can be interrupted in the circumferential direction, so that a plurality of profile sections and / or threaded sections are formed.
  • the at least one threaded portion or its bottom which is formed by the outer circumference of the coupling member in the region of the at least one threaded portion, may have at least a less pronounced profile than the profile portion and may therefore be referred to as low profile.
  • the torque required for a rotation of the coupling member is reduced or / and simultaneously generates a weak audible or tactile click during rotation, provided that the locking member is located in the at least one threaded portion.
  • the profilarme threaded portion may be profile-free, ie that the bottom of the threaded portion a z. B. forms smooth sliding surface or is.
  • the invention is characterized in that the coupling member from a position, in which engages the locking member in the at least one profile section, in a position in which engages the locking member in the at least one threaded portion, displaceable, in particular axially displaceable.
  • the locking member is located in the at least one threaded portion - no or at least a weaker click is perceived as in an engagement of the locking member in the at least one profile section.
  • the reason of the at least one threaded portion may be smooth.
  • the bottom of the at least one threaded section can have ribs, grooves, cams or the like, these elements preferably being less pronounced than the grooves of the at least one profile section.
  • the at least one threaded portion may be groove-shaped, wherein the groove flanks of the flanks, d. H. formed between the grooves ribs are formed. It is preferred that the bottom of the groove transitions flatly into the bottom of the at least one threaded portion.
  • the bottom of the at least one threaded portion and the bottom of the grooves may each be equidistant from the longitudinal axis of the coupling member.
  • the coupling member is preferably arranged in the injection device such that it carries out an axial movement in addition to the rotational movement during rotation.
  • This can apply in particular for a dosage in which the locking member engages in the at least one profile section, and / or for an actuation or product dispensing, for which the locking member engages in the at least one threaded section.
  • this combination of rotational and axial movement via a threaded engagement of the coupling member or a preferably rotatably coupled to the coupling member guide member into the surrounding the coupling member sleeve, in particular the housing of the Inj etechnischs device can be achieved.
  • the surrounding sleeve may have a thread into which a cam of the guide member or the coupling member engages, the z. B. can be formed gewindeabitessf ⁇ rmig.
  • this thread engagement is separate from the engagement of the locking member in the coupling member.
  • the pitch of the thread, which causes the combination of rotational and axial movement, and the pitch of the at least one threaded portion of the coupling member may be equal.
  • the pitch is so great that in a force applied axially to the coupling member, in particular in the dispensing or distal direction, no self-locking occurs, but rather a rotational movement of the coupling member is effected.
  • a spring member is provided against the force of the coupling member is axially displaceable.
  • the spring member may be a separate spring member or a spring member formed on the coupling member or, if present, a spring member formed on the guide member.
  • the coupling member may cooperate with the guide member such that the coupling member is movable only about the coupling stroke relative to the guide member.
  • the limited mobility can be carried out, for example, by means of stops formed on the coupling member and on the guide member, wherein a first cooperating stop pair blocks the movement in the proximal direction and a second cooperating stop pair blocks the movement in the distal direction.
  • the coupling member is part of an actuator.
  • the actuating device may in particular also comprise the guide member.
  • the coupling member may be part of an actuating device which is in threaded engagement with a sleeve surrounding the coupling member, in particular the housing of the injection device, so that a rotation of the coupling member relative to the housing causes an axial movement relative to the housing and vice versa.
  • the coupling member may be axially displaceable relative to the force of a spring member, wherein the guide member is threadedly engaged with the housing and wherein the coupling member and the guide member are rotatable relative to each other.
  • the injection device in particular the actuating device may comprise an engagement member which engages in the output device in the position in which engages the locking member in the at least one threaded portion of the engagement member in the output device is preferably such that the actuating device, in particular the coupling member rotationally fixed is connected to the output device.
  • the engagement member in the output device is preferred that a relative movement between the actuating device and the output device in the axial or longitudinal direction of the injection device is possible, ie, for example, that the actuating device is movable relative to the output device in the axial direction.
  • the actuator when actuated for discharge, may perform a combined rotational and axial movement, wherein only the rotational movement is transmitted to the output device.
  • the output device or at least a part thereof is axially fixed and rotatable relative to the housing.
  • the engaging member In an unactuated state of the actuating device, ie when the locking member is in the at least one profile section of the coupling member, the engaging member is preferably decoupled from the output device, ie disengaged.
  • the actuating device can be rotated or axially displaced in this position relative to the output device, so that the output device is not influenced by the movement of the actuating device.
  • the actuating device may comprise a dosing member, in particular in the form of a dose-indicating drum, which may be connected to the coupling member in a rotationally and axially fixed manner, for example.
  • the dosing member may, for example, have a scale arranged on its circumference, at which the product dose set by rotation can be read.
  • the housing of the injection device can have a window through which a discrete value of the scale can be read.
  • the dose scale can be arranged helically around the dosing member. The slope of the Helix preferably corresponds to the pitch of the threaded engagement of the actuator into the housing which effects the combined rotational and axial movement.
  • the actuator may have an actuator at its proximal end, which may be pressed, for example, by the thumb of the user, thereby actuating the actuator.
  • Clutch stroke i. During the drive stroke, the actuator preferably performs a rotational movement, which is why it is advantageous that the actuator relative to the
  • Clutch member is freely rotatable so as to e.g. to decouple the user's thumb from the rotation.
  • the coupling member may preferably axially fixed to the
  • Coupling member or be connected to the dosing.
  • the output device comprises circumferentially distributed and extending in the longitudinal direction of the injection device grooves.
  • the engaging member is movable into engagement, wherein in this engagement between the engaging member and the output device, an axial relative movement is possible and a rotational movement is locked.
  • d. H. Screwing which aussselt the actuator during its operation, in particular during the drive stroke, preferably takes place between the engaging member and the output device only an axial relative movement. It is generally preferred that in the coupled state of the engagement member, the actuator and the output device perform a rotational movement acting in the same direction.
  • the output device may be one or more parts.
  • the output device on actuation of the coupling member axial movement in the discharge direction on a piston which acts on a product run.
  • the output device in particular a piston rod, apart from a flange acting on the piston, be integrally formed, wherein the piston rod at its outer periphery of the above grooves for engagement of the engaging member and a thread which is superimposed on the grooves , having.
  • the regions disposed between two adjacent threads may form the grooves exhibit.
  • the thread of the piston rod may be in engagement with the housing of the injection device, wherein the piston rod during its rotation a dispensing movement, ie aussselt one on the product to be dispensed or acting on the product piston.
  • the output device is multi-part and comprises at least one output member and a piston rod.
  • the output device may have an output member, which is, for example, sleeve-shaped.
  • the output device may have a piston rod, which is preferably surrounded by the output member.
  • Output member and piston rod may be connected to each other so that a rotational movement of the output member causes axial movement of the piston rod.
  • the output member is rotatable and axially fixed relative to the housing of the injection device.
  • the piston rod for example, engage with a thread in the driven member, so that a rotational movement of the driven member relative to the piston rod causes an axial movement of the piston rod relative to the housing and the driven member.
  • the piston rod can in this case be accommodated relative to the housing in a rotationally fixed and axially displaceable manner in the housing or be supported therefrom. Suitable means for this are extending in the longitudinal direction of the piston rod groove or flattening.
  • the thread with which the piston rod engages in the driven member in this case can be opposite to the thread with which the actuating device engages in the housing.
  • the output member is non-rotatably connected to the piston rod, wherein the piston rod is axially movable relative to the output member. Suitable means for this are extending in the longitudinal direction of the piston rod groove or flattening.
  • the piston rod engages with its thread in the housing, so that a transmitted to the piston rod rotational movement of the output member screws the piston rod in the distal direction.
  • the thread of the piston rod has the same sense of rotation as the thread with which the actuating device engages in the housing. It is generally preferred that the thread of the piston rod has a smaller pitch than the thread with which the actuating device engages in the housing.
  • a stop member may be provided which serves at the last dose setting to allow only the setting of a product dose equal to the rest of the product contained in the injection device equivalent.
  • the stop member is preferably in threaded engagement with the actuator.
  • the stop member is sleeve-shaped and arranged between the actuating device, in particular the coupling member, which may have, for example, the thread for the stop member, and the output device, in particular the output member.
  • the thread in which the stop member engages preferably has a smaller pitch than the thread with which the actuator is in engagement with the housing and also preferably but not necessarily a smaller pitch than the thread with which the output means is in engagement with the housing.
  • the stop member is preferably in engagement with the output device in such an engagement that the stop member is rotatably and longitudinally movable relative to the output device. Preferably, this engagement, as well as the engagement in the thread of the actuator permanently.
  • the actuator is rotatable relative to the output device and also relative to the stop member. Due to the threaded engagement of the actuator with the stop member and the longitudinal displaceability of the stop member relative to the output device, the stop member is axially displaced during dose setting.
  • the injection device preferably comprises a stop, which may be formed, for example, by the actuating device to which the stop member is displaced a little further with each dosing.
  • the stop member is moved into engagement with the stop. A further metering is therefore no longer possible, since the stop member located in the stop with the actuating device increases the number Product dose locks. This ensures that no higher product dose can be set than can actually be distributed, which can be used to avoid misuse.
  • the at least one profile section and / or the at least one threaded section are bounded in the circumferential direction by a section extending in the longitudinal direction, which can be profile-poor or even profile-free - a special case of low profile.
  • the coupling member has two profilme sections extending in the longitudinal direction.
  • a profilmenmen section is preferably so long that it extends over the axial length of at least one profile section, in particular over the axial length of all profile sections.
  • the at least one profilme section can extend in the longitudinal direction over the length over which profile sections are arranged.
  • the several profilarmen sections are preferably evenly distributed over the circumference.
  • the at least one profilme section has, in particular, a width extending in the circumferential direction of the coupling member which may be larger or smaller, but preferably equal to the width of the at least one profile section extending in the circumferential direction.
  • the at least one profile section and the at least one profiled section extend in the circumferential direction approximately by the same arc length.
  • the angles which span the arc lengths of the two profile sections and of the two profiled sections are each about 90 °, irrespective of the at least one threaded section.
  • the at least one profilme section such as the at least one threaded portion be groove-shaped, wherein the groove flanks are formed by the at least one profile section, in particular by the flanks of the grooves.
  • the at least one profiled section and the at least one threaded section can each form sliding surfaces for the locking member, which have the same distance to the longitudinal axis of the coupling member.
  • the sliding surfaces are preferably formed by the outer circumference of the coupling member. Due to the configuration of the coupling member with at least one profilarmen section, the production of the coupling member is much easier because not over the entire circumference a profile needs to be arranged, which facilitates the demoulding of preferably injection-molded coupling member from the tool and also simplifies the production of the tool.
  • the locking member is a first locking member, wherein the injection device in addition to the first locking member has a second locking member, wherein the first and second locking member are arranged so that one, preferably only one, engages the two locking members in a profile section.
  • the other locking member namely that which does not engage in the profile section, engage in a profilarmen section. It is therefore preferred that the first locking member and the second locking member are arranged according to, in particular offset in the circumferential direction.
  • the first and the second locking member in the circumferential direction and / or offset from each other in the axial direction.
  • the first and second locking member to each other in the circumferential direction by an angle - or a suitable multiple thereof - offset, which corresponds to the angle which spans the arc length of the profilarmen section or the profile section.
  • this angle may be approximately 90 ° in a coupling member with two profilarmen sections.
  • the first and second locking member engages in the axial displacement of the coupling member to the coupling stroke in a threaded portion
  • the first and second locking member are axially offset from one another.
  • the first and second locking member are axially offset relative to the product of the pitch of the at least one threaded portion and the angular offset of the locking members in the circumferential direction with respect to 360 °.
  • the first and second locking member lie on a helical line, which has the slope of the at least one threaded portion.
  • FIGS. 2 A to 2D show different views of the injection device from FIGS. 1A to 1D in a state with a set product dose
  • FIGS. 3 A to 3 D show different views of the injection device from FIGS. 1A to 1D in a state after the coupling stroke has taken place
  • FIG. 4 shows a perspective view of a housing and a housing
  • Figure 5 is a perspective view of a housing and a
  • Figure 7 shows different views of an injection device with in
  • FIG. 8 shows different views of the injection device from FIG. 7 after a completed coupling stroke
  • FIG. 9 shows an actuating device with a circumferential direction
  • Figure 10 shows different views of an injection device with in
  • Circumferentially extending arms for an engaging member and before a coupling stroke
  • FIG. 11 shows different views of the injection device from FIG. 10 after the coupling stroke has taken place
  • Figure 12 is a coupling member, a guide member and a combination thereof with itself in the longitudinal direction of the I ⁇ jetechnischsvorraum extending arm for an engaging member, and
  • Figure 13 is a coupling member, a guide member and a combination thereof and a circumferentially extending arm for a
  • the injection device comprises an actuating device 6, 7, 12, 13, which is arranged in a multi-part housing 1, 2, 3.
  • the housing 1, 2, 3 has an outer housing 1, an inner housing 2, which is rotatably and axially fixed to the outer housing 1 and a functional sleeve 3, which is also rotationally and axially fixed to the outer housing 1 and the inner Housing 2 is connected.
  • the housing could be formed in one piece. Due to the multi-part of the housing, however, there are advantages during assembly.
  • a product container 4 is arranged, which has a distal, provided for a needle end and a proximal, with a displaceable piston 4a closed end.
  • the product container 4 is closed by a septum which can be perforated by the needle when attached to the housing.
  • the injection device shown is delivered with an inserted product container 4.
  • Product container 4 is not interchangeable, so it is a so-called Disposable injection device is. In principle, the product container 4 could also be formed directly by the outer housing 1.
  • the injection device further comprises an output device 9, 10, 11, which has a driven member 9, a received in the driven member 9, provided with an externally threaded piston rod 10 and disposed at the distal end of the piston rod 10 flange 11. Via the flange 11 a dispensing movement is transmitted to the piston 4a in the distal direction for product distribution.
  • the flange 11 is freely rotatable relative to the piston rod 10 and axially fixedly coupled to the piston rod 10.
  • the piston rod 10 has flats into which engages the sleeve-shaped output member 9 and thus permanently prevents rotation of the piston rod 10 relative to the output member 9, but an axial displacement of the piston rod 10 relative to the output member 9 allows.
  • the output member 9 is rotatably and axially fixed relative to the housing 1, 2, 3 by means of a rotary bearing 3a formed on the housing 1, 2, 3, in particular on the functional sleeve 3.
  • the threaded rod 10 engages with its external thread in the internal thread 3 c of the functional sleeve 3 a.
  • the piston rod 10 engage with its thread in an inner thread formed on the tubular output member 9 and, e.g. with its flattening, rotationally fixed and axially displaceable can be received by the function sleeves 3.
  • the piston rod 10 then has a thread with a sense of rotation, which is opposite to the direction of rotation of the thread in the embodiment described first.
  • a rotation of the output device, ie the output member 9 and the piston rod 10 in one direction causes an axial displacement of the piston rod 10 in the distal direction due to the threaded engagement of the piston rod 10 with the thread of the functional sleeve 3 c or - alternatively - the output member 9.
  • the piston rod 10 screws in the distal direction.
  • the screwing movement of the piston rod 10 in an axial movement of the piston 4a that is transferred to a delivery stroke, whereby the product is distributed.
  • Each saw-toothed rib 9a has a flat and steep flank.
  • the flat flank makes it possible to rotate the output member 9 in a direction in which the piston rod 10 is displaced in the distal direction.
  • the steep flank prevents rotation of the output member 9 in the other direction of rotation, whereby the piston rod 10 would be screwed in the proximal direction. This ensures that the piston rod 10 can only be screwed in the distal direction, ie in the dispensing direction.
  • the sawtooth-shaped ribs 9a are arranged distally of the region of the output member 9 which is arranged in the rotary support 3a.
  • the output member 9 evenly distributed over its circumference and extending in the longitudinal direction of the injection device grooves, as can be seen for example from Figure Ic.
  • These grooves are in the scholarsfo ⁇ n shown sawtooth, but may also have other shapes, in particular symmetrical tooth shapes.
  • the grooves serve as a security against rotation and as a longitudinal guide for a sleeve-shaped stop member 8, which surrounds the output member 9 and engages with its inside in the grooves of the output member 9
  • the stop member 8 relative to the output member 9 permanently rotatable and axially displaceable.
  • the grooves arranged on the outer circumference of the output member 9 furthermore serve, in particular predominantly, for preventing rotation between the two
  • Actuating 6, 7, 12, 13 and the output device 9, 10, 11 optionally to produce a rotational movement of the actuator 6, 7, 12, 13 on the
  • the Betschistsemcardi 6, 7, 12, 13 is used in the embodiment shown also for dose adjustment, which is why they can also be referred to as metering and actuating device 5, 6, 7, 12, 13.
  • Actuator 5, 6, 7, 12, 13 comprises a dose display drum 5, which in a
  • the dose display drum 5 has a helical around the
  • Dose display drum 5 running dose scale on.
  • the currently set product dose can be read by the window Ia (FIG. 1A) formed in the outer housing 1.
  • a handle is formed ( Figure IA), at which the user of the I ⁇ jetechnischsvortechnisch by gripping and turning a torque on the Dose indicating drum 5 and thus on the metering and actuating device 5, 6, 7, 12, 13, in particular for dose adjustment exercise.
  • the dose-indicating drum 5 also has, at its proximal end region, a shoulder formed radially inward, on which, for example, a stop 5a for the proximal end of the stop member 8 can be formed. The function of the stop member 8 will be described later in more detail.
  • a trained as a button actuator 12 is at the proximal end of the actuator 5, 6, 7, 12, 13, freely rotatable and axially fixed
  • the actuator 12 relative to Housing 1, 2, 3 as an adapter for eg a thumb of the user of the device relative to the housing 1, 2, 3 are fixed, while the rest of the actuator 5, 6, 7, 12, 13 relative to the housing 1, 2, 3 performs a rotational movement.
  • the actuating device 5, 6, 7, 12, 13 further comprises a sleeve-shaped coupling member 6 axially and rotationally locked to the dose indicating drum 5.
  • the coupling member 6 has an internal thread on its inner circumference, which in particular is permanent in an external thread of the stop member 8 , engages.
  • the thread has a relatively small pitch, which is preferably only so large that the thread is self-locking.
  • the coupling member 6 On the outer circumference of the coupling member 6 distributed over the circumference arranged profile sections 6b, which have a plurality of juxtaposed, extending in the longitudinal direction and a profile forming ribs or grooves 6a arranged.
  • the coupling member 6 has, in cross section, two profile sections 6b and two profiled sections, here profile-free or smooth sections 6c, over the circumference.
  • Each profile section 6b is peripherally bounded on each side by a profile-free section 6c.
  • Each profile section 6b has a plurality of grooves 6a arranged uniformly next to each other.
  • the profile sections 6b and the profile-free sections 6c extend in cross-section of the coupling member 6 over substantially the same circular arc section length.
  • each of the sections 6b, 6c is about one quarter of the circumference of the coupling member 6 long.
  • the grooves 6a are formed by radially outwardly projecting ribs, which also extend in the longitudinal direction, wherein between two adjacent ribs, a groove is arranged.
  • the ribs or the grooves 6a have flattened flanks, so that a locking element 2b engaging in the groove, which is preferably designed as a locking cam 2b, is pressed out of engagement with a groove 6a when the torque applied to the coupling member 6 is sufficient the engagement with the next groove 6a device. This will create an audible or tactile click.
  • the locking cam 2b is formed on the inner housing 2 via a resilient arm which presses the locking cam 2b against the outer periphery of the coupling member 6.
  • the inner housing 2 has a total of two such locking cams, wherein the two locking cams are offset axially in the circumferential direction by 90 ° and in the axial direction by a quarter of the way that performs the coupling member 6 in a complete rotation. Since the profile sections 6b and the profile-free sections 6c each extend approximately 90 ° over the circumference, it is ensured that during the rotation of the coupling member 6 always one of the two locking cams 2b in a profile section 6b and the other of the two locking cams 2b in the profile-free Section 6c intervenes. The fact that the profile sections 6a extend only partially over the circumference of the coupling member 6, a simple production of the coupling member 6 is made possible.
  • the coupling member 6 has at its periphery further threaded portions 6d, in particular threaded guides or thread grooves which extend through the profile sections 6b, i. extend in sections over the circumference of the coupling member 6.
  • the threaded portions 6d are at least as wide in the longitudinal direction of the injection device, as the locking cam 2b.
  • the metering and actuating device 5, 6, 7, 12, 13 further comprises a guide member 7, which is rotatably connected in this exemplary embodiment with the coupling member 6.
  • the coupling member 6 is axially, ie along the longitudinal axis of the injection device in particular by a Kupplungshub h displaced.
  • the guide member 7 has at least one, in this example, two radially projecting engagement cam 7a, which extend in sections over the circumference of the guide member 7.
  • the inner housing 2 has an internal thread 2a in the form of a helically encircling groove into which the engagement cam 7a extends.
  • the Eingrifmocken 7a therefore, although it only partially extends over the circumference of a corresponding helical form or slope to fit into the thread 2a.
  • a rotational movement of the guide member 7 thus causes its axial movement and vice versa.
  • the path traveled by the actuating device 5, 6, 7, 12, 13 in one revolution corresponds to the pitch of the thread 2a.
  • the threaded sections 6d preferably also have the same pitch as the thread 2a.
  • the thread 2a is a double-threaded thread, wherein a first Eingrifmocken 7a engage in the first thread and a second Eingrifmocken 7a in the other thread.
  • the coupling member 6 is limited along the longitudinal axis relative to the guide member 7 in both directions and movable to the Kupplungshub h. To fall out of the
  • Actuator 5, 6, 7, 12, 13 to prevent from the proximal end of the housing 1, 2, 3, a movement of the coupling member 6 relative to the guide member 7 in the proximal direction by axially engaging, on the coupling member 6 and
  • Clasp trained spring member 15 which surrounds a cam b hook-shaped and is attached to the coupling member 6, take over.
  • the coupling member 6 and the guide member 7 are pressed apart as far as the above-mentioned travel limits allow it.
  • the coupling member 6 can be displaced by a coupling stroke h relative to the guide member 7 in the distal direction, wherein the spring member 15 ( Figures 12 and 13) is tensioned.
  • the actuating device 5, 6, 7, 12, 13 has an engaging member 13.
  • the engagement member 13 may, as shown in Figures 6-8 and 12 or 9-11 and 13, be arranged in various ways. However, the arrangements shown have in common that the engagement member 13 in the movement of the coupling member 6 relative to the guide member 7 in the distal direction radially inwardly, d. H. is pressed in the direction of the longitudinal axis of the injection device.
  • the inwardly pressed engagement member 13 engages with its engagement portion 13a ( Figures 12 and 13) in the grooves formed on the outer circumference of the output member 9.
  • an anti-rotation between output member 9 and engaging member 13 is formed, the engaging member 13 is in turn rotationally fixed to the dosing actuator 5, 6, 7, 12, 13, d. H. connected to the coupling member 6 ( Figure 12) or the guide member 7 ( Figure 13).
  • the engagement members 13 shown in Figures 6-8 and 12 or 9-11 and 13 also have in common that they are arranged in particular at the end of a resilient arm.
  • the resilient arm is in particular integrally formed on the coupling member 6 ( Figure 12) or on the guide member 7 ( Figure 13). The arm makes it possible that the engagement member 13 is pressed in the distal direction during displacement of the coupling member 6 by the Kupplungshub h and moved when moving the coupling member 6 in the coupling stroke h opposite direction out of engagement with the output member 9.
  • the engagement member 13 has a first gear member 13b, which faces radially outward.
  • the first gear element 13b has a gear surface, which is formed according to the mechanism of action of an inclined plane.
  • the transmission element 13b is brought into engagement with a second transmission element 14 during the execution of the clutch stroke, which may be formed by the guide member 7 (FIG. 12) or the coupling member 6 (FIG. 13).
  • the second transmission element 14 has a radially inwardly facing gear surface, which can also act according to the laws of an inclined plane.
  • the engagement member 13 may, as shown in Figure 12 along the longitudinal axis of the injection device have.
  • the arm on which the engaging member 13 is disposed is fixed to the coupling member 6.
  • the arm pointing along the longitudinal axis could be arranged on the guide member 7, in which case the second transmission element 14 could be arranged on the coupling member 6 instead of on the guide member 7.
  • the engagement member 13 may be formed on a circumferentially extending arcuate arm, as shown in FIG. The curvature corresponds to the radius at which the arm is spaced from the longitudinal axis.
  • the arm 13 is formed on the guide member 7, and the second transmission member 14 is formed on the coupling member 6.
  • the extending in the circumferential direction arm could be arranged on the coupling member 6, in which case the second transmission element 14 could be arranged on the guide member 7.
  • serpentine spring elements 15 or, as shown in FIG. 13, spring elements 15 designed as clasp have proven to be particularly advantageous.
  • the injection device is preferably delivered in the state shown in Figures IA to ID.
  • the coupling member 6 is pressed by the spring member 15 shown in Figure 12 or 13 relative to the guide member 7 in the proximal direction and held there.
  • the metering and actuating device 5, 6, 7, 12, 13 is in this case still unconfirmed.
  • One dose is not yet set.
  • At least one locking cam 2b engages in a profile section 6b of the coupling member 6.
  • the metering and actuating device 5, 6, 7, 12, 13 and the output device 9, 10 are not rotatably coupled in this state.
  • the handle formed at the proximal end of the dose indicating drum 5 is applied with a torque by the user of the injection device.
  • the metering and actuating device 5, 6, 7, 12, 13 is set in rotation, whereby they screwed out of the housing 1, 2, 3 in the proximal direction due to the threaded engagement 7a, 2a.
  • One of the two latching cams 2b engages in a profile section 6b, ie in a groove 6a, the other latching cam 2b engaging in a profile-free section 6c.
  • an audible or tactile signal is generated, which indicates the rotation of the metering and actuating device 5, 6, 7, 12, 13.
  • the output device 9, 10 performs during the dosage no rotational movement, since the engagement member 13 does not engage in the output member 9. An unintentional rotation, z. B. caused by the clicking vibrations is prevented by the latching engagement of the locking element 3b in the output member 9.
  • the stop member 8 is shown in Figures 2 and 3 differing from Figure 1 only in the representations C, but this is not to say that no stop member 8 is present.
  • FIG. 4 shows how the inner housing 2 and the coupling member 6 cooperate at the end of a dose setting and before actuation of the metering and actuating device 5, 6, 7, 12, 13.
  • a cam 2b engages in the grooves 6a of the profile section 6b.
  • Figures 2 A to 2D show the Injelichsvorrichrung in an inflated state in which the desired product dose in the window Ia is read.
  • the dosing actuator 5, 6, 7, 12, 13 is actuated and First, as shown in Figures 3A to 3D, the coupling member 6 is moved together with the actuator 12 and the dose display drum 5 in the distal direction by the coupling stroke h relative to the guide member 7.
  • FIGS. 3A to 3D show the injection device in a state shifted by the coupling stroke h.
  • the dose indicator drum 5, the coupling member 6 and the guide member 7 due to the threaded engagement 7a, 2a screwed distally in the housing 1, 2, 3 and offset due to the engagement of the engaging member 13 in the output member 9, the piston rod 10 in one of the same direction of rotation directed rotation, alternatively - in a threaded engagement between the piston rod and driven member - in no rotation.
  • the distance between the proximal end of the stop member 8 and the stop 5 a remains constant.
  • the stop member 8 is moved back towards the stop 5a. This can be repeated until the stop member 8 abuts against the stop 5a, wherein at this moment an increase in the product dose is no longer possible, even if the scale value of the Dose indicator drum 5 still allow another dosage.
  • the distance of the stop member 8 to the stop 5 is adjusted so that the stop member 8 then abuts against the stop 5 a, when the piston 4 a assumes its most distal position in a distribution then carried out.
  • Figures 6, 7 and 8 show the injection device in the embodiment with an axially extending arm for the engagement member 13, wherein the arm is attached to the coupling member 6.
  • FIG. 7 shows the injection device with an unactivated metering and actuating device 5, 6, 7, 12, 13 d. H. that the engagement member 13 does not engage in the output member 9.
  • a displacement of the coupling member 6 by the coupling stroke h ( Figure 7) causes the engagement member 13 engages the output member 9, whereby the coupling member 6 is rotatably coupled relative to the output member 9 ( Figure 8).
  • Figs. 9, 10 and 11 the injection device in the embodiment with a circumferentially extending arm for the engaging member 13 is shown.
  • the arm is arranged on the guide member 7 in this example.
  • the injection device is shown in an unactuated state, d. h., That the engaging member 13 does not engage in the output member 9.
  • the engagement member 13 is pressed due to the interaction of the transmission elements 13b and 14 radially inwardly into a rotationally fixed engagement with the output member 9.

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  • Engineering & Computer Science (AREA)
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  • Biomedical Technology (AREA)
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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un système d'injection permettant l'administration d'un produit, lequel système comprend : a) un élément à encliquetage (2b) et b) un élément d'accouplement (6) présentant, sur son pourtour, au moins une section profilée (6b) et au moins une section filetée (6d), c) ledit élément d'accouplement (6) pouvant être amené d'une position, dans laquelle l'élément à encliquetage (2b) s'engage dans ladite au moins une section profilée (6b), à une position, dans laquelle ledit élément à encliquetage (2b) s'engage dans ladite au moins une section filetée (2d).
PCT/EP2008/009542 2007-11-13 2008-11-12 Système d'injection muni d'un mécanisme à encliquetage pouvant être désaccouplé WO2009062684A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP08850963A EP2219714A1 (fr) 2007-11-13 2008-11-12 Système d'injection muni d'un mécanisme à encliquetage pouvant être désaccouplé
CN200880124682XA CN101909678A (zh) 2007-11-13 2008-11-12 具有可脱耦的咔嚓机构的注射装置

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102007054020.7 2007-11-13
DE102007054020A DE102007054020A1 (de) 2007-11-13 2007-11-13 Injektionsvorrichtung mit entkuppelbarem Klickmechanismus
DE102007054019A DE102007054019A1 (de) 2007-11-13 2007-11-13 Injektionsvorrichtung mit betätigungsaktivierter Kupplung

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WO2009062684A1 true WO2009062684A1 (fr) 2009-05-22

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PCT/EP2008/009544 WO2009062686A1 (fr) 2007-11-13 2008-11-12 Système d'injection à accouplement activé par actionnement

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US8257319B2 (en) 2009-06-01 2012-09-04 Sanofi-Aventis Deutschland Gmbh Drug delivery device inner housing having helical spline
BR112012000786A2 (pt) * 2009-07-15 2016-02-23 Sanofi Aventis Deutschland conjunto de mancal de impulso, sistema de direção, e dispositivo de envio de medicamento
DE102009048497A1 (de) * 2009-09-26 2011-03-31 Haselmeier Gmbh Injektionsgerät
DK2506890T3 (da) * 2009-12-01 2020-09-21 Becton Dickinson Co Injektionspen med tilbagetræknings- og sidste-dosis-styring
TWI459984B (zh) * 2010-11-18 2014-11-11 Shl Group Ab 藥物輸送裝置
SG10201700601VA (en) 2011-03-16 2017-03-30 Becton Dickinson Co Multiple use disposable injection pen
US11577029B2 (en) 2012-03-15 2023-02-14 Becton, Dickinson And Company Multiple use disposable injection pen
DE102011116054A1 (de) * 2011-09-30 2013-04-04 Avenida Gmbh & Co. Kg Dosierspender
US8807399B2 (en) 2011-09-30 2014-08-19 Avenida Gmbh & Co. Kg Dispenser
CN104010677B (zh) 2011-10-17 2016-08-24 Shl集团有限责任公司 药物输送装置
EP3068471B1 (fr) * 2013-11-15 2020-01-01 Sanofi-Aventis Deutschland GmbH Élément et ensemble pour dispositif d'administration de médicament, dispositif de distribution de médicament et utilisation d'un élément
RU2696459C1 (ru) * 2019-02-21 2019-08-01 Общество с ограниченной ответственностью «НЭКСТ БИО» Инъекционное устройство

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WO2009062686A1 (fr) 2009-05-22
DE102007054020A1 (de) 2009-05-14

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