WO2004064902A1 - Dispositif permettant l'administration d'une dose predeterminee d'un produit liquide - Google Patents

Dispositif permettant l'administration d'une dose predeterminee d'un produit liquide Download PDF

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Publication number
WO2004064902A1
WO2004064902A1 PCT/CH2004/000027 CH2004000027W WO2004064902A1 WO 2004064902 A1 WO2004064902 A1 WO 2004064902A1 CH 2004000027 W CH2004000027 W CH 2004000027W WO 2004064902 A1 WO2004064902 A1 WO 2004064902A1
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WO
WIPO (PCT)
Prior art keywords
dose
scale
drive member
feed direction
sleeve
Prior art date
Application number
PCT/CH2004/000027
Other languages
German (de)
English (en)
Inventor
Fritz Kirchhofer
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
Publication of WO2004064902A1 publication Critical patent/WO2004064902A1/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
    • A61M5/31565—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
    • A61M5/3158—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 axially moving actuator operated by user, 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
    • A61M5/31533—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
    • A61M5/31555—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
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—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
    • 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
    • A61M5/31536—Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • 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
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston

Definitions

  • the present invention relates to a device for administering a predeterminable dose of a liquid product, preferably a disposable injection pen.
  • the dose to be administered is usually set with a protective cap.
  • the numbers from 1 to 20 are printed on the protective cap. After removing the protective cap, it is therefore not possible to say with absolute certainty which dose has actually been set. Replacing the protective cap can cause even more uncertainty because the protective cap can be replaced in any desired position.
  • the other integer multiples of the number 20, i.e. the numbers 20, 40, 60 ..., are printed on a dosing button, so that the dose scale consists of sections that are relatively far apart but can be read together, which makes handling even more difficult.
  • An effective dose setting is actually accomplished by twisting an ampoule sleeve relative to the pen mechanism. When the injection pen is screwed on, the ampoule sleeve can therefore be rotated, which means that the dosage is adjusted and the effective dosage can no longer be checked.
  • a device for example, from DE 199 00 827 C1 by the applicant.
  • the actually set dose is displayed in accordance with the principle described in WO 97/36 626 by the applicant, according to which a dosing arrow on a mechanical holder with one on one rotatable metering element interacts with the printed dose scale.
  • the reading accuracy is comparatively low. Problems with the reading accuracy occur in particular when larger numbers of dose units that are far in the double-digit dose unit range are to be clearly displayed.
  • the preferably sleeve-shaped mechanism holder has a viewing window on its outer circumference, in which there is at least a section of the dose scale, the section cooperating with a marking coupled to the dose setting mechanism in the interior of the mechanism holder in order to indicate the actually set dose of the device.
  • the viewing window which is designed as a recess or integrated on the outer circumference of the mechanism holder, can be closed off by a transparent material to protect the device mechanism.
  • the marking can be a color field contrasting in color with the other elements, a color marking, for example line or spiral marking.
  • the element which is provided with the marking preferably also serves as a stop which is axially adjustable, for example by axial displacement or by turning a threaded rod or the like, in order to limit a maximum stroke of the piston for injection. It is advantageous that the adjustment movement of the element or the stop element can be used automatically for the axial adjustment of the color marking, so that no further elements are required for a dose display.
  • the dose scale is preferably formed in two parts and comprises a first section which is used to display larger dose units, for example integer multiples of 10 dose units, and a second section which is used to display smaller dose units, for example fractions of the larger dose units, for example 1 unit Dose units with the numbers 1 to 9.
  • at least a section of the dose scale is arranged at the viewing window, preferably in the axial direction, ie in the direction of advance of the color marking, and along a long side of the viewing window.
  • the section indicating the smaller dose units is preferably a number which is distributed at equal angular intervals over the outer circumference of a sleeve-shaped, rotatable metering element.
  • the numbers 0 to 9 can be arranged on the front edge along the outer circumference of a metering element.
  • the adjustment length of the marking corresponds to a scale part of the section indicating the larger dose units, for example the 10-point scales, when the metering member rotates. It is advantageous that even larger dose units can be displayed precisely and clearly with this simple arrangement. Because even with a comparatively small diameter of the metering element, according to the invention the numbers 0 to 9 can be arranged clearly visible along the outer circumference. According to the invention, no higher digits, in particular no integer multiples of the larger dose units, have to be attached to the comparatively small outer circumference. This enables a clear and easy-to-use display of the actually set dose.
  • a drive device is constructed in two parts and comprises a drive member that can be moved in and against the feed direction of the piston and a driven member that can only be moved in the feed direction and locked against the feed direction.
  • the driven member is secured against displacement against the direction of advance of the piston relative to the mechanism holder, for which purpose latching means are provided on the rod body, which cooperate with correspondingly designed latching means which are connected to the mechanism holder.
  • the drive member comprises further correspondingly designed latching means which interact with latching means on the rod body.
  • FIG. 2 shows a plan view of the injection device according to FIG. 1 in a zero position and in a metering position
  • Fig. 3 shows an injection device according to a second embodiment of the present
  • FIG. 4 shows the injection device according to FIG. 3 in a top view in a zero position and in a metering position with a dose which is actually set and which is different from zero.
  • the injection device 1 shows a longitudinal section of an injection device, in the exemplary embodiment an injection pen, according to a first embodiment of the present invention.
  • the injection device 1 has a housing with a front housing sleeve 2 and a rear housing sleeve 7 that can be firmly connected to it, for example screwed on.
  • the front housing sleeve 2 serves as a receptacle for an ampoule 4 serving as a product container.
  • the ampoule 4 contains a liquid product, preferably a solution or suspension containing a therapeutic or medicinal active substance, for example insulin, the product being displaced axially in the ampoule longitudinally displaceable piston 5 is poured out of the outlet opening 3 of the ampoule.
  • the external thread of the threaded rod 6 has a sequence of sawtooth-shaped flanks pointing in the feed direction and essentially radially inwardly directed edges.
  • the locking hooks 9, 10 form an acute angle with the rotational and longitudinal axis L of the thread of the threaded rod 6, which corresponds to the angle of the flank of the external thread of the threaded rod 6.
  • the locking hooks 9, 10 end in the axial direction at different heights, corresponding to the pitch of the external thread. Due to the interaction of the front end of the locking hooks 9, 10 with the rear edge of a respective tooth flank, the driven member 6 is secured against displacement from axial pulling out. However, the locking means 9, 10 do not act on an axial advancement the threaded rod 6 counter.
  • the elastically designed locking means 9, 10 are bent radially outward when the threaded rod 6 is advanced in order to slide on the tooth flanks.
  • the angular position of the threaded rod 6 and the positions of the front ends of the locking means 9, 10 are coordinated with one another such that the locking means 9, 10 in the zero position shown in the upper part of FIG. 2, in which a vanishing dose is set, or in the case of integers Engage 10-packs (10, 20, 30 ...) completely on the back of the assigned tooth flank.
  • the sleeve-shaped drive member 19 When the dosing button 11 is rotated counter to the direction of rotation of the external thread of the output member 6, the sleeve-shaped drive member 19 also rotates due to the coupling through the sleeve part 13. Due to the thread engagement by the threaded nut formed by the two drivers 21, 22 at the front end of the drive member 19, the drive member 19 thus moves upward when the metering knob 11 is turned on the thread of the output member 6 and is thus adjusted axially outward.
  • a cam 20 gradually migrates into the empty space 18 formed with the sleeve-shaped stop element 16 until the axially rear end of the cam 20 has reached the front end of the stop sleeve 16. in which case a maximum administrable dose would be set.
  • the injection of the liquid contained in the ampoule 4 is effected by axially advancing the metering button 11 serving as an actuating element, which, due to the coupling through the sleeve part 13, ensures the rotationally fixed Drive member 19 axially advances.
  • the viewing window 17 can also be formed in the original molding process, for example in two-component injection molding from an opaque plastic component and a transparent one for the viewing window. In the zero position of the injection device shown in FIG. 1, i.e. when the dose actually set disappears, the rear end of the cam 20 is aligned with the front end of the viewing window 17 or with a zero marking provided on the viewing window 17 (not shown).
  • a marking (not shown) arranged on the outer peripheral surface of the drive member 19 in the region of the viewing window 17 can be aligned with the front end of the viewing window 17 or the aforementioned zero marking. In this way, the user is shown the zero position of the dosing device.
  • the cam 20 or the aforementioned mark provided on the outer circumferential surface of the drive member 19 moves further and further into the viewing window 17 when the drive member 19 is axially reset. According to the invention, this is used to display the actually set dose.
  • the outer peripheral surface of the cam 20 and the outer peripheral surface of the drive member 19 form a clearly perceptible color contrast in the region of the viewing window 17 behind the cam 20.
  • the outer peripheral surface of the drive member 19 has the same color as the outer peripheral surface of the rear housing sleeve 7 and the outer peripheral surface of the cam 20 forms a color contrast.
  • a color pattern with a perceptible contrast for example black and white
  • the 10th scale 25 acts with the one coupled with the dosing button 11 Mark on the outer peripheral surface of the cam 20 together to indicate the actually set dose. More precisely, the dose actually set is made up of the integer multiples of the number 10 read on the 10-scale 25 and the numerical value read on the 1-scale 24. Even with a small diameter of the rear housing sleeve 7, numbers that are sufficiently legible and range from 0 to 9 can be affixed to the outer peripheral surface of the front end 12 of the metering button 11. Thus, according to the invention, larger cans can also be set so that they are easy to read.
  • the numbers on the first scale 24 can also be arranged directly on the outer circumferential surface of the drive member 19 in the region of the viewing window 17 and / or on the outer circumferential surface of the cam 20 with sufficient contrast to the background.
  • the numerical values from 0 to 9 would be arranged in a spiral on said outer peripheral surface at uniform angular distances.
  • the injection device is brought into the zero position shown in FIG. 1 and in the upper part of FIG. 2, where a further axial advancement of the output member 6 towards the outlet opening 3 due to the abutment of the front end of the cam 20 at the rear end of the circumferential projection 8 is reliably prevented.
  • no product can be poured out of the ampoule 4 without renewed dosing.
  • the color marking on the outer circumferential surface of the cam 20 has moved out of the viewing window 17 in the zero position and shows the marking arrow 26 for the numerical value “0” on the first scale 24 at the front end of the operating button 11.
  • the dosing button 11 is turned so that the cam 20 is axially reset due to the thread engagement at the front end of the drive member 19 into the external thread of the output member 6.
  • the color marking on the outer circumferential surface of the cam 20 gradually moves into the viewing window 17.
  • the metering button 11 is moved back by the axially measured, clear metering distance X and gives a clear view of a stop 15 of the rear housing sleeve 7.
  • the user can adjust the actually set one Read off the dose at any time by reading the 1 scale 24 and the 10 scale 25. If the user has accidentally set a dose that is too large, he can reduce it again by turning back the dosing button 11, unless a locking means, not shown, prevents turning back of the dosing button 11 in a still further embodiment.
  • the dosing button 11 and the sleeve part 13 are connected to one another in such a way that the dose can be selected on the one hand by means of the dosing button 11, but on the other hand a relative rotation can take place between the dosing button 11 and the sleeve part 13 for the purpose of zeroing.
  • the dosing button 11 and the sleeve part 13 are not decoupled from one another, ie no slip clutch is provided.
  • the injection device in the event of a zeroing, the injection device must then be moved into the zero position shown by axially advancing the dosing button 11 in order to be able to reliably set a new dose.
  • the sleeve-shaped metering button 11 can be pulled out of the injection device 1 relative to the sleeve part 13 or the sleeve-shaped stop element 16 while maintaining its angular position.
  • latching means pressing against the inner circumference of the dosing button 11 radially advance on the outer circumferential surface of the sleeve 13.
  • the dosing button 11 is pushed back axially, the sleeve part 13 or sleeve-shaped stop element 16 coupled to the drive member 19 is then axially advanced.
  • the cam 20 stops again to reach the zero position the above-mentioned ones Latching means released, so that the dosing button 11 can completely return to its starting position.
  • a toothed rack 27 serves as the output member.
  • the toothed rack 27 is formed by a rod body which is rectangular in cross section and which is provided with a row of saw teeth on all four sides in a region at the front with respect to the feed direction.
  • two rows of teeth formed on opposite sides of the toothed rack 27, the blocking means 9, 10, are designated by 34 and 35.
  • the four rows of teeth have the same tooth pitch. They are arranged within a tooth pitch in relation to each other in an offset with respect to the feed direction, as is disclosed in detail in the applicant's referenced DE 199 00 827 C1.
  • the locking means 21, 22 or 9, 10 and two further locking means which cooperate with the respectively facing further rows of teeth, are at the same height with respect to the feed direction at 90 ° angular intervals. Because of the tooth row offset, only one of the locking means engages with a deepest tooth engagement in a tooth gap of the one facing it Row of teeth when the rack 27 is moved.
  • the three other locking means are each flanks of teeth of the rows of teeth facing them, so that these other locking means are elastically bent away from the rack 27.
  • a metering element 30 designed as a sleeve body is secured against displacement with the rear housing sleeve 7, for example due to the latching connection shown, but is rotatably connected about the common longitudinal axis.
  • the maximum dose path length that can be covered in the feed direction by the drive member 19 and the rack 27 is set, and thus also the maximum product dose that can be dispensed during an injection.
  • a front sleeve part 31 of the dosing member 30 is formed in a spiral circumferential manner on its front end face, ie the front sleeve part 31 progressively drops in a circumferential direction from a foremost end face section with respect to the longitudinal axis of the injection device 1.
  • the metering member 30 is rotated relative to the rear housing sleeve 7 until it has reached the desired metering position.
  • a clear metering distance remains between a further collar or cam 33, which also projects from the outer circumferential surface of the drive member 19, and the end face of the metering member 30 opposite these cams 33.
  • the drive member 19 can be withdrawn relative to the rear housing sleeve 7 and thus also relative to the piston 5 against the feed direction for product distribution. The withdrawal is carried out manually by axially pulling the cover 25 out of the injection device 1.
  • the dosing distance is equal to the dose path length in the subsequent product administration.
  • the toothed rack 27 When the drive member 19 is pushed back or pulled back, the toothed rack 27 remains in its displacement position previously assumed during the dosing process, relative to the housing, i.e., with proper operation, in the zero position shown in FIG. 3.
  • the rack 27 is secured against displacement against the feed direction by locking means 9, 10 formed on the rear housing sleeve 7.
  • the locking means 9, 10 are locking cams, which are each formed at a front end of an elastically flexible tongue and protrude radially inward from the tongue onto the rack 27.
  • the locking means 9, 10 each interact with one of the toothed rows of the rack 27 facing them, as described above, in such a way that they allow the rack 27 to be displaced in the feed direction and prevent a displacement against the feed direction by positive locking engagement.
  • the injection device in an initial position or zero position in which the rack 27 assumes its rearmost position relative to the rear housing sleeve 7 and also relative to the drive member 19.
  • the rear housing sleeve 7 is supplied completely assembled by the manufacturer with a toothed rack 27 and drive member 19 including cover 38 and metering member 30.
  • the starting position thus corresponds to the storage position of the injection device, in particular the drive and metering device of the injection device.
  • the injection device is a disposable pen. Reusability, ie replacement of the ampoule 4, can, however, be achieved with simple modifications.
  • the product dose to be administered with the first injection is set by the user.
  • the metering member 30 is rotated into a certain rotational position, which corresponds to the desired product dose.
  • the cam 33 of the drive member 19 has a clear metering distance from the front end face of the metering member 30 opposite it.
  • Only the locking means 9 is in the zero position on a tooth back of the row of teeth 34 on the locking stop. This also applies to the driver 21.
  • the other locking means and drivers are not completely in locking engagement with the assigned row of teeth.
  • the drive member 19 is pulled out of its foremost position with respect to the rear housing sleeve 7 against the feed direction by pulling the cover 38 out of the injection device 1.
  • the drive member 19 When the drive member 19 is retracted, its drivers 21, 22 slide over the tooth rows 34, 35 of the rack 27 facing them.
  • the rack 27 itself remains stationary since it is prevented from being taken along by the locking means 9 against the direction of advance.
  • the cover 38 and the drive member 19 coupled with it so that it cannot move are pulled out of the injection device 1 until the cam 33 comes to rest on the opposite front end face of the metering member 30. This tactile resistance is the signal to the user that the injection device 1 is charged and ready for injection.
  • the drive member 19 and thus also the rack 27 are shifted in the feed direction by pressing against the cover 38 by the preselected dose path length.
  • the rack 27 presses the piston 5 in the ampoule 4 on the Outlet 3 closed and product is poured out.
  • the distribution takes place until the collar or cam 29 protruding from the outer surface of the drive member 19 comes to a stop on the radially inward projection of the rear housing sleeve 7.
  • one of the locking means 9, 10 again engages completely in a tooth gap of the associated tooth rows 34 to 36 of the rack 27.
  • the locking means and drivers can all be arranged at the same height with respect to the direction of advance, which is described in detail in DE 199 00 827 C1 by the applicant.
  • FIG. 4 shows the injection device according to the second embodiment in a schematic plan view in two different dose positions, namely when 5 dose units are selected (upper part of FIG. 4) and when 37 dose units are selected (lower part of FIG. 4).
  • a viewing window 17 is provided in the outer lateral surface of the rear housing sleeve 7 serving as a mechanism holder, which provides a view into the interior of the rear housing sleeve 7.
  • the viewing window 17 there is preferably a window made of a transparent material, in particular plastic.
  • the spirally encircling front end face 32 of the front sleeve part 31 is clearly visible, which forms a line running obliquely to the viewing window 17 in the viewing window 17 in every rotational position of the metering member 30.
  • a suitable color marking can be provided on the spirally encircling front end surface 32, for example a color line with sufficient color contrast.
  • the front sleeve part 31 is colored in a clearly perceptible contrast to the rest of the metering element 30, so that the colored area 40 can be clearly perceived by the user.
  • the 10-scale 25 shown is provided, which shows how many tens dose units are preselected.
  • the scale of 10 forms the first part of the dose scale, which is also the 1-scale 24 comprises at the front end of the metering element 30.
  • the numbers on the 1-scale 24 (numbers 0 to 9) are preferably distributed at uniform angular intervals along the outer circumference of the metering element 30.
  • the 1-scale 24 is in turn formed by a plurality of 1-scale, which follow one another along the outer circumference of the metering element 30.
  • the several 1-scale scales of the scale 24 are each formed identically, each of these scales indicating the single dose units from 0 to 9.
  • the numbers on the 1-scale 24 can alternatively also be shown on the outer circumferential surface of the front sleeve part 31 in the area of the color marking 40 (with a color contrast to this) or in the area of the front sleeve part 31 contrasting in color (white in the lower part of FIG. 4) ) can be arranged, preferably also at uniform angular distances over an angular range of 360 °.
  • the numbers on the 1 scale 24 revolve in a spiral on the front sleeve part 31.
  • the numerical value of the 10th scale 25 is automatically within the range from 0 to 10.
  • a value other than zero is displayed on the 1-scale 24.
  • the 1-scale 24 is turned back to zero by rotating the metering element 30 before an injection.
  • the residual dose that may be produced is expelled.
  • the injection device 1 is then in the zero position, in which the next dose to be administered is set as follows.
  • the metering member 30 is rotated.
  • the numerals of the 1 st scale 24 run past the marking arrow 26 and the spirally encircling front end face 32 of the front sleeve part 31 gradually moves into the viewing window 17.
  • the desired dose is reached on the dose scales 24, 25.
  • the injection device is pulled out of the injection device 1 by pulling out the cover 38 and the drive member 19 coupled with it so that it is secured against displacement, until the cam 33 comes to rest on the end face of the metering member 30 opposite it.
  • the user then sticks the injection needle into the body tissue and administers the set dose by advancing the cover 38, which during the advancement advances the drive member 19 and the rack 27 which is in locking engagement therewith and the piston 5 by the set dose path length.
  • the aforementioned zero position is reached again, in which a new dose to be administered can be set again.
  • the color marking on the front sleeve part 31 can alternatively also be formed spirally itself.
  • An injection device is preferably constructed from plastic parts produced by injection molding and is preferably used for diabetes treatment by injecting preselected doses of insulin into the subcutaneous fatty tissue of a patient. In principle, however, any other liquid substances, in particular those containing a medicinal or therapeutic agent are administered.
  • a Gauge 31 or Gauge 30 injection needle is preferably placed on the front end of the front housing sleeve 2.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Dispositif permettant l'administration d'une dose prédéterminée d'un produit liquide, de préférence un stylo jetable. Ledit dispositif comporte un récipient pour le produit, dans lequel est placé un piston pouvant coulisser longitudinalement dans un sens d'avance, ainsi qu'un support de mécanisme en forme de manchon, un élément entraîné pouvant coulisser longitudinalement dans le support de mécanisme et agissant sur le piston, un dispositif d'entraînement pouvant être ajusté par rapport au support de mécanisme, dans le sens d'avance et dans le sens opposé, qui entraîne avec lui l'élément entraîné en cas de coulissement dans le sens d'avance, et un mécanisme de réglage de dose pourvu d'une graduation destinée à indiquer la dose effectivement réglée. Ledit dispositif se caractérise en ce que le support de mécanisme possède sur sa périphérie externe une fenêtre sur laquelle se trouve au moins un segment de la graduation qui coopère avec un marquage couplé au mécanisme de réglage de dose, à l'intérieur du support de mécanisme, pour afficher la dose effectivement réglée.
PCT/CH2004/000027 2003-01-21 2004-01-19 Dispositif permettant l'administration d'une dose predeterminee d'un produit liquide WO2004064902A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE2003102163 DE10302163A1 (de) 2003-01-21 2003-01-21 Vorrichtung zur Verabreichung einer vorgebbaren Dosis eines flüssigen Produkts
DE10302163.9 2003-01-21

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WO2004064902A1 true WO2004064902A1 (fr) 2004-08-05

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Cited By (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1704887A1 (fr) * 2005-03-26 2006-09-27 Tecpharma Licensing AG Dispositif de dosage avec fonction d'amorç age
WO2008148864A1 (fr) * 2007-06-08 2008-12-11 Tecpharma Licensing Ag Dispositif d'administration doté d'un élément d'affichage axialement mobile
US7727201B2 (en) 2005-04-29 2010-06-01 Tecpharma Licensing Ag Dosing device with priming function
WO2010139630A1 (fr) * 2009-06-01 2010-12-09 Sanofi-Aventis Deutschland Gmbh Mécanisme doseur pour la distribution de médicament présentant une dose maximale variable
US8257319B2 (en) 2009-06-01 2012-09-04 Sanofi-Aventis Deutschland Gmbh Drug delivery device inner housing having helical spline
US8585656B2 (en) 2009-06-01 2013-11-19 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for priming a drug delivery device
US8672896B2 (en) 2009-06-01 2014-03-18 Sanofi-Aventis Deutschland Gmbh Inner housing for a drug delivery device
US8728043B2 (en) 2009-06-01 2014-05-20 Sanofi-Aventis Deutschland Gmbh Drive mechanism for a drug delivery device
US8790315B2 (en) 2009-06-01 2014-07-29 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for a drug delivery device
US8974423B2 (en) 2009-06-01 2015-03-10 Sanofi-Aventis Deutschland Gmbh Resettable drug delivery device
CN104436375A (zh) * 2014-12-30 2015-03-25 江苏华阳电器有限公司 一种注射笔
US9005171B2 (en) 2009-06-01 2015-04-14 Sanofi-Aventis Deutschland Gmbh Resettable drug delivery device
WO2015082303A1 (fr) * 2013-12-05 2015-06-11 Novo Nordisk A/S Boîtier pour un dispositif d'injection médical
US9108007B2 (en) 2009-06-01 2015-08-18 Sanofi-Aventis Deutschland Gmbh Spindle and bearing combination and drug delivery device
US9125994B2 (en) 2009-06-01 2015-09-08 Sanofi—Aventis Deutschland GmbH Drug delivery device with dose dial sleeve rotational stop
US9238106B2 (en) 2009-06-01 2016-01-19 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for priming a drug delivery device
WO2016055619A1 (fr) * 2014-10-09 2016-04-14 Sanofi Boîtier et dispositif d'administration de médicament le comprenant, et procédé de production de boîtier
US9352097B2 (en) 2009-06-01 2016-05-31 Sanofi-Aventis Deutschland Gmbh Spindle for a drug delivery device
US9415165B2 (en) 2009-10-16 2016-08-16 Owen Mumford Limited Injector apparatus having a clutch to inhibit forward movement of the plunger
US9457150B2 (en) 2009-06-01 2016-10-04 Sanofi-Aventis Deutschland Gmbh Biasing mechanism for a drug delivery device
US9463283B2 (en) 2009-06-01 2016-10-11 Sanofi-Aventis Deutschland Gmbh Dosing mechanism for a drug deliver device
US9950116B2 (en) 2009-06-01 2018-04-24 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for priming a drug delivery device
US10799644B2 (en) 2015-06-01 2020-10-13 Novo Nordisk A/S Method for moulding a polymeric housing for a medical injection device

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EP1645301A1 (fr) 2004-10-11 2006-04-12 Novo Nordisk A/S Dispositif d'injection
ATE439156T1 (de) 2004-12-01 2009-08-15 Novo Nordisk As Injektionsvorrichtung
US8257318B2 (en) 2005-02-11 2012-09-04 Novo Nordisk A/S Injection device having a rotatable scale drum
DE102006061992B3 (de) * 2006-12-21 2008-06-12 Ghz Matra Ag Dosiervorrichtung

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DE4013769A1 (de) * 1990-04-28 1991-10-31 Adamaszek Franz Heinz Automatisches insulin-injektionsgeraet
FR2684880A1 (fr) * 1991-12-17 1993-06-18 Micro Dose Pharma Dispositif mecanique a afficheur d'une indication visuelle, telle qu'une graduation.
WO1997036626A1 (fr) 1996-04-02 1997-10-09 Disetronic Licensing Ag Dispositif d'injection
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DE20013579U1 (de) * 2000-08-08 2001-03-29 Adamaszek Franz Heinz Dosier- und automatisches Injektionsgerät

Cited By (46)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1704887A1 (fr) * 2005-03-26 2006-09-27 Tecpharma Licensing AG Dispositif de dosage avec fonction d'amorç age
US7727201B2 (en) 2005-04-29 2010-06-01 Tecpharma Licensing Ag Dosing device with priming function
WO2008148864A1 (fr) * 2007-06-08 2008-12-11 Tecpharma Licensing Ag Dispositif d'administration doté d'un élément d'affichage axialement mobile
US9238106B2 (en) 2009-06-01 2016-01-19 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for priming a drug delivery device
US10195354B2 (en) 2009-06-01 2019-02-05 Sanofi-Aventis Deutschland Gmbh Resettable drug delivery device
US8257319B2 (en) 2009-06-01 2012-09-04 Sanofi-Aventis Deutschland Gmbh Drug delivery device inner housing having helical spline
US9345840B2 (en) 2009-06-01 2016-05-24 Sanofi-Aventis Deutschland Gmbh Drug delivery dose setting mechanism with variable maximum dose
US8317757B2 (en) 2009-06-01 2012-11-27 Sanofi-Aventis Deutschland Gmbh Drug delivery device inner housing having helical spline
US8585656B2 (en) 2009-06-01 2013-11-19 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for priming a drug delivery device
US8672896B2 (en) 2009-06-01 2014-03-18 Sanofi-Aventis Deutschland Gmbh Inner housing for a drug delivery device
US8728043B2 (en) 2009-06-01 2014-05-20 Sanofi-Aventis Deutschland Gmbh Drive mechanism for a drug delivery device
US8790315B2 (en) 2009-06-01 2014-07-29 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for a drug delivery device
AU2010255805B2 (en) * 2009-06-01 2014-11-13 Sanofi-Aventis Deutschland Gmbh Drug delivery dose setting mechanism with variable maximum dose
US8974423B2 (en) 2009-06-01 2015-03-10 Sanofi-Aventis Deutschland Gmbh Resettable drug delivery device
US11654243B2 (en) 2009-06-01 2023-05-23 Sanofi-Aventis Deutschland Gmbh Inner housing for a drug delivery device
US9005171B2 (en) 2009-06-01 2015-04-14 Sanofi-Aventis Deutschland Gmbh Resettable drug delivery device
US11559628B2 (en) 2009-06-01 2023-01-24 Sanofi-Aventis Deutschland Gmbh Drug delivery device inner housing having helical spline
US9108007B2 (en) 2009-06-01 2015-08-18 Sanofi-Aventis Deutschland Gmbh Spindle and bearing combination and drug delivery device
US9352097B2 (en) 2009-06-01 2016-05-31 Sanofi-Aventis Deutschland Gmbh Spindle for a drug delivery device
US9125994B2 (en) 2009-06-01 2015-09-08 Sanofi—Aventis Deutschland GmbH Drug delivery device with dose dial sleeve rotational stop
US9149583B2 (en) 2009-06-01 2015-10-06 Sanofi-Aventis Deutschland Gmbh Drug delivery dose setting mechanism with variable maximum dose
US9199040B2 (en) 2009-06-01 2015-12-01 Sanofi-Aventis Deutschland Gmbh Drug delivery device last dose lock-out mechanism
WO2010139630A1 (fr) * 2009-06-01 2010-12-09 Sanofi-Aventis Deutschland Gmbh Mécanisme doseur pour la distribution de médicament présentant une dose maximale variable
US11471602B2 (en) 2009-06-01 2022-10-18 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for priming a drug delivery device
JP2012528619A (ja) * 2009-06-01 2012-11-15 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 可変の最大用量を備えた薬物送達の用量設定機構
US9125993B2 (en) 2009-06-01 2015-09-08 Sanofi-Aventis Deutschland Gmbh Inner housing for a drug delivery device
US9408978B2 (en) 2009-06-01 2016-08-09 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for priming a drug delivery device
US10391254B2 (en) 2009-06-01 2019-08-27 Sanofi-Aventis Deutschland Gmbh Inner housing for a drug delivery device
US9457150B2 (en) 2009-06-01 2016-10-04 Sanofi-Aventis Deutschland Gmbh Biasing mechanism for a drug delivery device
US9463283B2 (en) 2009-06-01 2016-10-11 Sanofi-Aventis Deutschland Gmbh Dosing mechanism for a drug deliver device
US9623187B2 (en) 2009-06-01 2017-04-18 Sanofi-Aventis Deutschland Gmbh Resettable drug delivery device
US10279116B2 (en) 2009-06-01 2019-05-07 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for priming a drug delivery device
US9950116B2 (en) 2009-06-01 2018-04-24 Sanofi-Aventis Deutschland Gmbh Dose setting mechanism for priming a drug delivery device
US10034982B2 (en) 2009-06-01 2018-07-31 Sanofi-Aventis Deutschland Gmbh Spindle for a drug delivery device
CN102458525A (zh) * 2009-06-01 2012-05-16 赛诺菲-安万特德国有限公司 具有可变最大剂量的给药剂量设定机构
US9415165B2 (en) 2009-10-16 2016-08-16 Owen Mumford Limited Injector apparatus having a clutch to inhibit forward movement of the plunger
US10806865B2 (en) 2009-10-16 2020-10-20 Owen Mumford Limited Injector apparatus having a clutch to inhibit forward movement of the plunger
US11033690B2 (en) 2009-10-16 2021-06-15 Owen Mumford Limited Injector apparatus having a clutch to inhibit forward movement of the plunger
US11819668B2 (en) 2009-10-16 2023-11-21 Owen Mumford Limited Injector apparatus having a clutch to inhibit forward movement of the plunger
US11241544B2 (en) 2013-12-05 2022-02-08 Novo Nordisk A/S Housing for a medical injection device
WO2015082303A1 (fr) * 2013-12-05 2015-06-11 Novo Nordisk A/S Boîtier pour un dispositif d'injection médical
CN107106770A (zh) * 2014-10-09 2017-08-29 赛诺菲 壳体和具有其的药物输送装置和壳体的生产方法
WO2016055619A1 (fr) * 2014-10-09 2016-04-14 Sanofi Boîtier et dispositif d'administration de médicament le comprenant, et procédé de production de boîtier
CN104436375A (zh) * 2014-12-30 2015-03-25 江苏华阳电器有限公司 一种注射笔
US10799644B2 (en) 2015-06-01 2020-10-13 Novo Nordisk A/S Method for moulding a polymeric housing for a medical injection device
US12017049B2 (en) 2015-06-01 2024-06-25 Novo Nordisk A/S Housing for a medical injection device

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