WO2008148864A1 - Dispositif d'administration doté d'un élément d'affichage axialement mobile - Google Patents

Dispositif d'administration doté d'un élément d'affichage axialement mobile Download PDF

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Publication number
WO2008148864A1
WO2008148864A1 PCT/EP2008/057039 EP2008057039W WO2008148864A1 WO 2008148864 A1 WO2008148864 A1 WO 2008148864A1 EP 2008057039 W EP2008057039 W EP 2008057039W WO 2008148864 A1 WO2008148864 A1 WO 2008148864A1
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WO
WIPO (PCT)
Prior art keywords
dose
indicator
display
scale
axis
Prior art date
Application number
PCT/EP2008/057039
Other languages
German (de)
English (en)
Inventor
Jürgen Wittmann
Aurèle HORISBERGER
Patrick Hostettler
Malte Kladiwa
Philippe Kohlbrenner
Peter Stettler
Stefan Meier
Martin Wittwer
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 WO2008148864A1 publication Critical patent/WO2008148864A1/fr

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Classifications

    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06M—COUNTING MECHANISMS; COUNTING OF OBJECTS NOT OTHERWISE PROVIDED FOR
    • G06M1/00—Design features of general application
    • G06M1/22—Design features of general application for visual indication of the result of count on counting mechanisms, e.g. by window with magnifying lens
    • 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
    • A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—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
    • 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
    • A61M5/31—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
    • A61M5/31541—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
    • A61M5/31561—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
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • A61M5/31595—Pre-defined multi-dose administration by repeated overcoming of means blocking the free advancing movement of piston rod, e.g. by tearing or de-blocking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps

Definitions

  • the invention relates to optically displaying a selectable dose of an injectable product in a device for administering the product.
  • WO 2006/037435 A1 discloses an administering device which, for indicating a set dose, has a first indicator member rotatable about an axis of rotation and a second indicator member rotatably movable together with the first indicator member and axially movable relative to the first indicator member along the axis of rotation ,
  • the second indicator member is threadedly coupled to a housing of the delivery device and rotates threadedly upon adjustment of the dose from the housing and returns to the housing upon dispense.
  • the first indicator member is rotatable relative to the housing but axially fixed.
  • the first indicator carries at its outer periphery a dose scale for the display of smallest adjustable dosage units.
  • the second indicator has at its outer periphery in spiral arrangement one behind the other several second dose scales for the display of tens of units of the dose.
  • the invention is based on a device for administering an injectable product comprising a housing with a receptacle for the product, a metering device for adjusting a dose of the product to be administered and a dispensing device for dispensing the dose.
  • the receptacle can directly form a container for the product itself or preferably serve as a receptacle for a container filled with the product, preferably an ampoule.
  • the metering device allows the setting of the dose preferably by means of a Einstellitchhoghoghoghoghoghoghoggereau an actuatable dosing.
  • such a dosing member may instead also be formed, for example, as a pushbutton or push button or pivoting arm, which allows adjustment of the dose by repeated actuation.
  • the dispensing device can have an axially movable delivery piston as a delivery member acting directly on the product.
  • the conveying member may also be, for example, a rotary conveying member or as known from perestaltic
  • the delivery device comprises a dose indicator having at least two relatively movable display members.
  • the at least two display members will hereinafter be referred to as the first display member and the second display member.
  • the first display element is provided with a first dose scale for the display of the dose in first scale steps.
  • the second indicator member is axially movable relative to the housing and relative to the first indicator member along a translation axis.
  • the second display element has a second dose scale extending axially along the translation axis for displaying the dose in second scale steps.
  • One of the dose scales indicates the dose in the smallest adjustable dosage units and has a label, preferably a digit, for each unit dose or a small multiple of the unit dose.
  • the other of the dose scales is used to display a larger multiple of the dose unit and their scale steps correspond to a certain multiple of the scale steps of the finer Dose scale.
  • the second dose scale is preferably also a numeric scale.
  • the finer dose scale is preferably a one-scale.
  • the coarser dose scale is preferably a tens scale.
  • the first indicator member is rotatably mounted about an axis of rotation relative to the second indicator member or also axially movable.
  • the first indicator member is rotated about the axis of rotation relative to the housing and the second indicator member, while the second indicator member is moved axially relative to the first indicator member and the housing.
  • the first indicator member is also axially moved relative to the housing and the second indicator member.
  • the housing forms a base or frame relative to which the display members are movable. This frame or housing surrounds the display members in preferred embodiments, but this is not required.
  • one of the display members may be an enveloping structure that partially or wholly surrounds the other display member and may also surround a portion of the housing understood as a stored rack.
  • the uniqueness of the reading during the setting of the dose is conducive when the display element with the coarser dose scale, which is a tenth scale in preferred embodiments, is driven at dose setting so that it only moves when the dose is around the Width of the scale steps changed on the coarser scale. If the display element with the coarser scale is moved back as preferred in the distribution towards a minimum dose position, preferably the zero dose position, this also applies accordingly to such a resetting of the dose indication.
  • the first display member executes only the rotational movement and the second display member only the axial translational movement.
  • the first indicator is relative to the housing in FIG Reference to its axis of rotation preferably axially fixed, in such embodiments relative to the housing so only a single degree of freedom of movement, namely that of the rotation about the axis of rotation.
  • the second display member is preferably straightened by an axial guide and secured against rotational movements, in such embodiments, therefore, only a single degree of freedom of movement relative to the housing, namely the axial mobility along its translation axis.
  • the rotation axis and the translation axis may in principle have an inclination to one another, they are more preferably at least substantially parallel to one another. Particularly preferably, the two axes coincide.
  • the second indicator member is thus axially movable parallel to the axis of rotation of the first display member.
  • the indicator members may well be disposed coaxially, for example by surrounding one another over at least a portion of its axial length.
  • the axis of rotation and a translational axis extending centrally through the second indicator are spaced parallel to one another.
  • the display members which are not arranged concentrically with respect to one another in such embodiments, may be arranged one inside the other over at least part of their axial length, relative to one another.
  • the display members are arranged side by side and relative to each other outboard, so that an outer peripheral surface of the one display member faces an outer peripheral surface of the other display member.
  • the numerals of the second dose scale can be arranged standing one above the other axially along the translation axis of the second indicator member or standing side by side transversely to the translation axis. If the first indicator is as preferred a rotary member and the numerals of the second dose scale with respect to
  • Circumferential around the axis of rotation of the first indicator member be particularly large and therefore easy and clear to read, or it can be increased the number of circumferentially juxtaposed digits to adjust the set dose per revolution of the first display member by as many dose units.
  • This is advantageous in particular for administration devices in which the distribution is effected by means of a drive spring, which is stretched when setting the dose.
  • a short spring travel of the drive spring is beneficial.
  • the first or the second indicator member may or may be arranged in adjusting the dose or distribution in a power flow of the dispenser to transmit a force required for dispensing to ultimately the conveying member acting directly on the product. More preferably, however, the indicator members are located outside of such a force flow so that they do not transmit force to the conveyor member upon discharge.
  • One of the indicator members or both indicator members may or may not be arranged in a force flow between the metering device and the dispenser when adjusting the dose, if a force should ever be transferred from the metering device to the dispenser during the adjustment of the dose.
  • the arrangement outside the respective power flow i. Outside of the power flow during the discharge or a possible force flow in the dose selection, opens constructive freedom in terms of the shape and arrangement of the display elements and in particular the dose scales.
  • the display elements can be designed structurally simpler. They only have to fulfill their actual function, namely to display the set dose.
  • the display members are preferably returned by the distribution back to an initial state, so that they show the complete dose of the set dose again the zero dose or any other deviating other minimum dose.
  • the display members are coupled with the Aus state worn in the distribution.
  • the power flow is preferably branched within the Aus structure worn in the distribution, with a branch through the entire Aus phase learned leads to the conveyor member and a side branch to the Display members.
  • the sidelobe may lead via the indicator members or one of the indicator members to another means of the delivery device, but preferably terminates at one of the indicator members.
  • the dispensing device comprises a transmission device, within which the power flow branches, in that the transmission device is coupled on its output side via a first coupling with the conveyor element and via another coupling with one of the display elements.
  • the dispenser may include a drive spring that is tensioned by increasing the dose at the time of adjustment and releases the absorbed spring energy upon dispense, thereby driving the conveyor.
  • the dispenser may be arranged so that the user must apply a portion of the force required for the dispensing and the drive spring only supports him. More preferably, however, only the triggering of the drive spring is required for the discharge, and the drive spring applies the force required for the discharge after the release alone.
  • the dispenser is decoupled in such embodiments after the release of the user. This has in administration devices in which the product is administered by means of a hypodermic needle, the advantage that the user does not have to apply in addition for the distribution of force after insertion of the needle and the trigger force in the longitudinal direction of the injection needle.
  • the drive spring may be a gas pressure based spring. More preferably it is a mechanical spring, for example a compression spring or even more preferably a torsion spring.
  • a torsion spring is particularly advantageous when the dose selection made by means of a Dosierwebglieds and the torsion spring is stretched around the axis of rotation of Dosiermosglieds.
  • the metering device is preferably coupled to the first indicator member, the coupling being formed such that movement that an actuatable metering member of the dose-setting metering device effects causes movement of the first indicator member.
  • the dosing member is the input member of the metering device. If the dosing member, as preferred, a dosing rotary member and the first indicator member as preferably rotatable, the rotational movement of the dosing member can be transmitted via a transmission to the first display member. Particularly preferred are the rotary dosing member and the rotatable display member coaxial, that is rotatable about the same axis of rotation. In such embodiments, the dosing member and the first indicator member can be connected to each other in a rotationally secured manner via the coupling.
  • the actuatable dosing member and the first indicator member may be arranged immovable relative to each other or even formed from one piece. More preferably, they are connected to each other via a Dosierkopplung, which is released in the distribution.
  • the dosing member is preferably coupled via the first indicator member to the second indicator member.
  • the force flow which causes the movements of the indicator members in the setting of the dose from the dosing member via the first display member to the second indicator member.
  • the dosing member can instead also be coupled to the first display element via the second display element.
  • the dosing member may be coupled to the first indicator member on the one hand and to the second indicator member while bypassing the first indicator member, on the other hand. Accordingly, in such embodiments, the flow of force downstream of the dosing member branches into a branch to the first indicator and another branch to the second indicator.
  • the indicator members may be interconnected via one or more coupling members to transmit movement of one of the indicator members to the other effected by adjustment of the dose by means of the metering device so as to perform its movement necessary to display the dose. More preferably, the two indicator members are directly engaged with each other, which couples the indicator members together so as to coordinate with respect to each other to perform their respective movement for indicating the dose.
  • one of the indicator members preferably the first indicator member, forms a track and the other an engaging member which is guided along the track.
  • the guideway is preferably shaped so that when a rotatable with an axially movable display member combination, the rotational movement of the rotatable display member in the axial movement of the axial movable display member is transformed.
  • the housing or a non-rotatably connected to the housing intermediate member leads the axially movable second indicator member thereby preferably secured against rotation.
  • the dispensing device is preferably decoupled from the metering device when setting the dose.
  • the dispensing device comprises an actuating member, preferably a push button, which is movable in the longitudinal direction of the administering device or transversely to the longitudinal direction.
  • the actuator is preferably decoupled in setting the dose of a conveying member of the Aus which heard.
  • the delivery device is equipped with a drive spring for the delivery, the drive spring and the delivery element are preferably decoupled in the setting of the dose and are coupled together for the distribution.
  • the administration device has a discharge coupling for decoupling in the dose selection and the coupling for the distribution.
  • the subject of the claimed invention is an administering device with a dose display with at least two display members, one of which is axially movable relative to the housing and the other is rotatable or axially movable.
  • a further subject of the invention is an administration device with a dose indicator with a display member which is axially movable relative to a housing of the device along a translation axis and rotationally secured with respect to the translation axis.
  • this indicator may correspond to the second indicator of the invention claimed herein. It may be the only indicator of the dose display or with one or more other display members form the dose display.
  • all embodiments of this application also apply to this further invention.
  • the axially movable display element also need not be provided with a dose scale. Instead, it can also have a window which can be moved along an otherwise formed, axially extended dose scale and through which this scale can be read. Instead of a window, it can also form a pointer movable along such a dose scale, whereas a window as a brand is preferred. Further advantageous features are described in the subclaims and their combinations.
  • FIG. 1 shows an administration device in a perspective view and with a dose display of a first embodiment
  • FIG. 2 shows the administration device with an exposed dose indicator
  • FIG. 3 shows a display element of the dose display
  • FIG. 4 shows the administering device in a first longitudinal section
  • FIG. 5 shows the administration device in a second longitudinal section
  • FIG. 6 shows a dose display of a second exemplary embodiment in a perspective view with components shown individually;
  • Figure 7 shows the dose display of the second embodiment in a longitudinal section in the assembled state
  • FIG. 8 shows the dose display of the second embodiment in a further perspective view in the assembled state.
  • Figure 1 shows in a perspective view a device for administration of an injectable product, for example insulin, a growth hormone or an osteoporosis preparation.
  • the administering device comprises a distal housing part 1 and a proximal housing part 2, which are firmly and non-detachably connected to each other and together form a slender, elongated housing.
  • Such delivery devices are also referred to as an injection pen because of their size and shape.
  • an ampoule is received, which contains the product to be administered.
  • a needle unit with a pointing in the longitudinal direction of the device injection needle can be fastened.
  • the housing part 1 at its distal end a thread for a screw fastening the Needle unit on.
  • the ampoule is visible through two lateral windows Ia, which are recessed in the housing part 1.
  • the administration device has a dosing member 4 and an actuating member 5 at its proximal end.
  • the dosing member 4 is on the housing part 2 about a central longitudinal axis
  • the dosing member 4 formed as a knob serves to select, i. the setting of an injectable dose of the product.
  • Actuator 5 is axially movable along the axis R and acts as a trigger, by the actuation of the set dose is distributed.
  • the actuator 5 is as
  • Push button formed i. the payout is made by pressure actuation of the
  • Actuator 5 causes in the distal direction.
  • the administering device has a dose display according to a first embodiment for displaying the set dose.
  • the dose display is a two-digit numerical display with a dose scale E and a dose scale Z, which is indicated by a
  • the two dose scales E and Z namely the one-scale E and the Z-scale Z, each consist of a sequence of
  • the housing 1, 2 in the embodiment, the housing part 2, has on one side an elongated along the axis R, shaped as a bulge
  • FIG. 2 shows the administering device in the same view as FIG. 1, however, the proximal housing part 2 has been removed, exposing the dose indicator.
  • the dose indicator includes a first indicator member 10 provided with the dose scale E and a second indicator member 12 provided with the dose scale Z.
  • the indicator member 10 is reciprocable about the axis R relative to the housing 1, 2 and display member 12.
  • the axis R is thus, the rotational axis of the display member 10.
  • the display member 12 is relative to the housing 1, 2 and the display member 10 along the axis R back and forth axially movable, ie the axis R forms a translational axis for the display member 12.
  • the housing in the exemplary embodiment, the housing part 2, surrounds both display members 10 and 12, forms a pivot bearing for the display member 10 and leads the display member 12 along the translation axis R axially straight.
  • the dosing member 4 and the first indicator member 10 are arranged coaxially with respect to the common axis of rotation R and connected during the adjustment of the dose torsionally rigid, so that they are rotatable together when setting about the rotation axis R.
  • the indicator members 10 and 12 are mechanically coupled to each other such that rotation of the indicator member 10 caused by adjustment of the dose causes axial movement of the indicator member 12 along the axis of rotation R in accordance with the scale steps of the two dose scales E and Z.
  • the display members 10 and 12 are directly coupled to each other by being in guiding engagement with each other.
  • the display member 10 is provided with a guide track 11 and the display member 12 is provided with an engaging member.
  • the track is formed as a recess on the outer peripheral surface of the indicator member 10. More specifically, it has two guideways formed by the two oppositely facing side walls of the recess. The one side wall guides the engagement member projecting into the recess when the indicator member 10 moves in the one direction of rotation, and the opposite side wall guides the engagement member and thus the indicator member 12 in the rotational direction of the indicator member 10 in the other direction of rotation.
  • FIG. 3 shows only the second display element 12.
  • the mentioned engagement element is recognizable and provided with the reference number 13.
  • the display member 12 is rod-shaped axially elongated. More specifically, it is shaped as a slender thin beam having a short cylindrical section shaped to conform to the peripheral surface of the indicator member 10. It is provided at its in the installed state outwardly facing top with the Dosisskala Z. The numerals of the dose scale Z are axially superimposed on the top and increasing in value from proximal to distal arranged.
  • the engagement member 13 protrudes in the proximal end region from the underside of the indicator member 12 and is formed as a simple, short cam.
  • the guideway 11 spirals on an outer peripheral surface of the display member 10 in a plurality of turns about the rotation axis R. It is formed on the peripheral surface of a groove. It runs continuously from a distal end to a proximal end, but changes the slope with respect to the axis of rotation R over several times.
  • the guideway 11 is composed of first guide sections I Ia and second guide sections I Ib, which follow one another alternately.
  • the guide portions 11a extend around the rotation axis R only in the tangential direction, i. they have the slope zero. They are axially spaced apart from each other and each extend over a larger part of the circumference of the display member 10.
  • the guide portions I Ib connect two guide portions I Ia.
  • the guide portions 1 Ib are inclined with respect to the rotation axis R and each have the same pitch. If the display member 10 performs a rotational movement, the display member 12 maintains its axial position as long as long as the engaging member 13 engages in one of the guide portions I Ia. If the engagement member 13 in the rotational movement of the display member 10 in the region of one of the guide sections I Ib, it and thus the display member 12 is imposed an axial movement corresponding to the pitch and the length of the guide portions 1 Ib, i. the display member 12 moves on by a predetermined axial distance on, when the engaging member 13 passes from one of the guide portions I Ia via one of the guide portions I Ib in the next following of the guide sections I Ia.
  • the guide track 11 has, in each winding extending over 360 ° about the rotation axis R, ie, per revolution, two guide sections I 1b inclined with respect to the rotation axis R.
  • the guide sections Ib follow each other in the circumferential direction about the rotation axis R at equal angular intervals, correspondingly the guide sections 11a are each of equal length.
  • the second indicator member 12 axially moves in two discrete steps in each complete revolution of the first indicator member 10, namely one movement step in each half revolution.
  • Both dose scales E each comprise a complete number or sequence of numbers from "0" to "9".
  • the numerals or numbers of the dose scale E are arranged in the circumferential direction one behind the other and in relation to the rotation axis R as the numbers or digits of the dose scale Z standing. Because of the upright orientation, the numbers or numbers of the dose scale E can be so large that they can be read easily and clearly, although in the circumferential direction two complete dose scales E are provided at the same axial height one behind the other on the outer peripheral surface of the display member 10. In alternative embodiments, the numerals or numbers of the dose scale E can be increased by assigning each discrete movement step of the second display element 12 at least one complete revolution of the first display element 10.
  • the guideway 11 per turn, ie per complete revolution about the axis of rotation R, in each case only one of the guide portions I Ib.
  • a correspondingly larger angle of rotation is required by which such a modified display member 10 must be rotated in the setting of the dose.
  • the guide track 11 extends over a rotation angle of 4 ⁇ 360 ° with 10 dose units per half revolution, so that the maximum adjustable and distributable dose corresponds to 80 dose units.
  • the dose scales E and Z always, but only then, move one scale step if the dose changes by the increment of the respective dose scale E or Z. This is achieved by the fact that the dose scale Z moves only when the dose is full
  • the set dose corresponds to that in the crossing area of the
  • Dose scales E and Z adjacent pair of digits This pair of digits can be read through the display window 14 (FIG. 1).
  • FIG. 4 shows the administering device in a longitudinal section in an initial state.
  • an ampoule 3 as is customary for example for the administration of insulin, added.
  • a needle unit with a hypodermic needle 19 is attached at the distal end of the housing part 1.
  • the injection needle 19 extends along the axis of rotation R.
  • the needle unit further comprises a protective cap for the injection needle 19, which is withdrawn before a first use of the injection needle 19.
  • an outer protective cap is further attached to the housing part 1, which surrounds the needle unit including the inner protective cap.
  • a conveyor member 9 is arranged.
  • the delivery member 9 is a piston which is displaceable in the ampoule 3 in the direction of the injection needle 19 in order to dispense product through the injection needle 19. By adjusting the dose of the stroke is determined, the conveyor member 9 travels per discharge.
  • the conveyor member 9 is part of a dispensing device and is its last, acting directly on the product Aus hereglied.
  • the discharge device comprises an output device with a first output member 7, a second output member 8 and the conveyor member 9.
  • the output member 8 acts directly on the conveyor member 9 and forms a piston rod in the embodiment.
  • the output members 7 and 8 are rotationally secured with respect to the axis of rotation R connected to each other, but relative to each other axially movable.
  • the second output member 8 has around the rotation axis R a thread 8a, in the exemplary embodiment, an external thread which is in threaded engagement with a mating thread of an engaging member 2a.
  • the engagement member 2 a is connected to the housing part 2 in a manner secured against rotation with respect to the axis of rotation R. It can be molded with the housing part 2 in one piece or secured against rotation attached to this.
  • the engaging member 2a is formed as a threaded nut.
  • the second output member 8 is in threaded engagement with the engaging member 2a rotatable about the rotation axis R and along the rotation axis R movable.
  • the first output member 7 is rotatable relative to the housing part 2 about the rotation axis R in a first rotational direction.
  • a rotational movement in the opposite second direction of rotation is prevented by an effective in the second direction of rotation reverse lock, which is a friction clutch in the embodiment.
  • the reverse rotation prevents the second output member 8 can perform an axial movement in the proximal direction in threaded engagement with the engaging member 2a, but leaves for the distribution in the distal Towards leading rotary motion.
  • the reverse rotation lock is formed by anti-rotation means 2b and 7b, which are in constant engagement with each other.
  • the anti-rotation means 2b are immobile relative to the housing part 2, but elastically yielding, and the anti-rotation means 7b are immovable relative to the output member 7.
  • the anti-rotation means 2b are formed on a shell inner surface of the housing part 2, and the anti-rotation means 7b are formed on a ring which is fixed or formed on the driven member 7.
  • the output members 7 and 8 are telescopic relative to each other. They overlap each other axially.
  • the output member 8 protrudes axially into the output member 7 and can be extended during the discharge from the output member 7.
  • the rotationally secured engagement of the output members 7 and 8 is formed by means of at least one axially extending groove of one of the output members and at least one rib extending on the other output member, which is guided axially in the groove and causes a rotational drive of the output member 8 in a rotary drive of the output member.
  • the dispensing device further comprises a transmission device 6, which forms an input member of the Aus pattern adopted by a transfer force causing the discharge is initiated in the transmission device 6.
  • the transmission device 6 is rotatable as a whole back and forth about the rotation axis R and along the rotation axis R axially movable back and forth. It is stretched by a return spring 17 in the proximal direction by the return spring 17 exerts on the transmission device 6 acting in the proximal direction spring force.
  • the return spring 17 acts as a compression spring and presses in the proximal direction on the transmission device. 6
  • a drive spring 15 is supported.
  • the drive spring 15 generates the drive force by exerting on the transmission device 6 a force acting in the circumferential direction about the axis of rotation R spring force.
  • the drive spring 15 is formed in the embodiment as a spiral spring with a plurality of wound around the rotation axis R and surrounding spring coils. It is supported at one end, in the exemplary embodiment with its inner end, on the transmission device 6 and with its other end, in the embodiment, the outer end, on a support 16, the non-rotatably connected to the housing part 2, relative to this but axially movable is.
  • the transmission device 6 is rotatable relative to the support 16 about the rotation axis R.
  • the transmission device 6 is connected secured against rotation with the first display element 10 with respect to the rotation axis R, but is axially movable relative to the display element 10.
  • the transmission device 6 and the display member 10 are engaged with each other, which prevents relative rotational movements and permits relative movements in the axial direction.
  • at least one axially extending groove and an axially extending rib are formed on mutually facing peripheral surfaces of the transmission means 6 and the display member 10 which engage with each other.
  • a plurality of such anti-rotation means are respectively formed on the transmission device 6 and on the display member 10.
  • the anti-rotation means of the display member 10 are denoted by 10 a and formed on an inner peripheral surface of the display member 10.
  • the anti-rotation means of the transmission means 6 engaged therewith are on an outer peripheral surface of the transmission means
  • the transmission device 6 forms together with the first output member 7 a discharge coupling.
  • the transmission device 6 has Aus detailkupplungsstoff 6a and the output member 7 has Aus thoroughlykupplungsstoff 7a which connect the transmission device 6 with respect to the rotation axis R against rotation with the driven member 7 in the clutch engagement, however, allow an axial relative movement of the transmission device 6.
  • the Aus thoroughlykupplungsstoff 6 a and 7 a are formed as axially extending grooves and engaging ribs. Basically, a single groove and a single rib would suffice.
  • the clutch engagement is made for the payout and maintained during the payout.
  • the dosing member 4 is connected secured against rotation with the actuator 5, as long as the actuator 5 as shown in Figure 4 assumes its proximal end position.
  • the dosing member 4 forms a translational stop on which the actuator 5 abuts in the proximal end position, the return spring 17 presses a stop surface of the actuator 5 against a counter-abutment surface of the dosing member 4.
  • Dosierkupplungsmittel 4a and 5a are formed, which produce the rotationally secured engagement of the dosing member 4 and the actuator 5 in the dose selection.
  • the dosing member 4 and the actuator 5 forms with their Dosierkupp treatment means 4a and 5a a Dosierkupplung which is releasable against the restoring force of the return spring 17 by the actuator 5 is moved relative to the housing part 2 in the distal direction, typically by a with the Thumb pressure applied.
  • the actuator 5 is connected non-rotatably connected to the transmission device 6 with respect to the rotation axis R.
  • the actuator 5 is also immovably connected to the transmission device 6 also axially in both directions.
  • the dosing member 4 is in a latching engagement with the housing part 2, which allows rotational movements of the dosing member 4 for the purpose of setting the dose.
  • the latching engagement generates a holding force sufficient to prevent rotational movement of the transmission device 6 due to the driving force of the drive spring 15 when the dosing clutch 4a, 5a is closed.
  • Figure 5 shows the administering device without ampoule 3 and without needle unit in a longitudinal section, which is rotated relative to the longitudinal section of Figure 4 by 90 °.
  • the device is also in the initial state.
  • the section of FIG. 5 also includes, in particular, the second display element 12.
  • the display element 12 is accommodated in a receptacle 2c formed by the housing part 2.
  • the receptacle 2 c further forms on both axial longitudinal sides of the display member 12 each have an axial guide to prevent movements of the display member 12 in the circumferential direction about the rotation axis R.
  • the guides are 2 d as axially elongated Molded guideways. In principle, however, only a selective intervention would be sufficient as long as sideways movements are prevented.
  • the user takes the delivery device in the initial state shown in Figures 4 and 5 in one hand and sets with the other hand by turning the dosing 4, the desired dose.
  • the dosing 4 locked in each case in a predetermined rotational locking position with the housing part 2.
  • the transmission device 6 rotates together with the actuator 5.
  • the first display member 10 rotates together with the transmission device 6.
  • the engaging in the guide track 11 indicator 12 is in accordance with the rotational angle adjustment of the display member 10 axially in the moved proximal direction.
  • the user reads the dose through the display window 14 in the crossing region of the two dose scales E and Z from.
  • the drive spring 15 When setting the dose, the drive spring 15 is stretched more when the dose is increased.
  • the metering device formed by the dosing member 4, the actuator 5 and the transfer device 6 also allows dose corrections, ie a decrease in the dose. In the case of a dose correction, the spring force of the drive spring 15 decreases.
  • the return spring 17 presses the transfer device 6 in the proximal direction and thus in the engagement of the dosing 4 a, 5 a.
  • the transmission device 6 is free in this axial position of the first output member 7. Rotational movements of the transmission device 6 are thus not transmitted to the output member 7 and the drive train in the downstream members 8 and 9 of the output device in this dosing.
  • the metering 4-6 therefore rotates freely of the output device 7-9, but always in engagement with the dose indicator E, Z.
  • the user removes the outer protective cap and also removes the inner protective cap of the needle unit so that the injection needle 19 projects freely at the distal end of the administering device.
  • the user holds the administering device with one hand and the hypodermic needle 19 facing the body. In this position, he can read the set dose comfortably and clearly and make sure in this way again that the dose was set correctly.
  • the actuator 5 presses in its axial movement, the transmission device 6 relative to the output member 7 in the distal direction.
  • the discharge coupling means 6a and 7a engage, so that the transfer device 6 and the output member 7 are connected to each other secured against rotation.
  • the dosing coupling is loosened in the further course of the axial movement in that the dosing coupling means 4a and 5a are released from the rotation-secured engagement.
  • the common release movement of the actuator 5 and the transmission device 6 is completed when the return spring 17 is compressed.
  • the drive spring 15 causes the transfer device 6 to rotate.
  • the transmission device 6 takes over the Aus detailkupplung 6a, 7a, the first output member 7, ie the transmission device 6 and the output member 7 rotate at the now onset of payout together about the rotation axis R. Because of the rotationally secured engagement rotates the second output member 8 together with the output member. 7 and threads in threaded engagement with the engaging member 2a relative to the driven member 7 in the distal direction.
  • the output member 8 presses in its advancing movement against the conveying member 9, so that this also advances in the ampoule 3 and product is discharged through the injection needle 19.
  • the payout is limited by a stop, preferably a twist stop, against which the transfer device 6 or a in the distribution and dosage with this jointly rotating other member in the circumferential direction about the rotation axis R comes to a stop.
  • a stop preferably a twist stop
  • a stop preferably a twist stop
  • the indicator member 10 Since the non-rotational engagement between the transmitter 6 and the indicator member 10 also exists during dispensing, the indicator member 10 is returned to the zero dose position and the indicator member 12 is also axially returned to its zero dose position in guiding engagement with the indicator member 10, i. H. the dose indicator E, Z is "zeroed" at the end of a proper distribution process.
  • the injection needle is pulled out of the tissue again, and the device is ready for a new injection, i. H. for the re-adjustment and distribution of a dose.
  • the stop member 18 enters a stop position and prevents further increase in the dose.
  • the dose indicator E, Z indicates the amount of product still in the ampoule.
  • Figures 6 to 7 show a dose display E, Z according to a second embodiment.
  • the dose indicator of the second embodiment may replace the dose indicator of the first embodiment with the administering device.
  • Figure 6 shows the components of the dose display of the second embodiment.
  • the numbers or numbers of the dose scale E are arranged lying with respect to the axis of rotation R.
  • the numbers or numbers of Dose scale Z are aligned accordingly, ie they are transverse to the axis of rotation R axially adjacent.
  • the numbers or digits of the dose scale E are arranged as in the first embodiment with respect to the axis of rotation R at the same axial height in the circumferential direction one behind the other.
  • only a dose scale E is arranged in the circumferential direction, ie a complete rotation of the dosing 4 causes the increase or decrease of the dose by 10 dose units.
  • a further modification is that the dose indicator of the second embodiment comprises a first indicator member 10 ', not only with respect to the
  • an inner sleeve 10 and an outer sleeve 20 includes.
  • the inner sleeve 10 has as in the first
  • the guideway 11 which has twice as many turns and per turn only a single inclined guide portion 1 Ib.
  • the outer sleeve 20 serves as a carrier of the dose scale E, which is provided on the outer circumference of the outer sleeve 20 at its distal end.
  • FIG. 7 shows the dose display of the second embodiment in the mounted state, wherein the other components of the administering device have been omitted for the sake of simplicity.
  • the outer sleeve 20 and in particular its dose scale E surrounds the display member 12.
  • the dose scale E is located radially outward with respect to the axis of rotation R than the dose scale Z.
  • the modified display member 10 is in particular the same as the display member

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Abstract

Dispositif d'administration d'un produit injectable, comprenant g) un boîtier (1,2) pourvu d'un logement (1) pour le produit, h) un dispositif de dosage pour régler une dose de produit, i) un dispositif d'administration pour administrer la dose, j) un premier élément d'affichage (10) comportant une première échelle de dosage (E) pour afficher la dose dans des premières graduations d'échelle, k) un deuxième élément d'affichage (12) qui, relativement au boîtier (1,2) et au premier élément d'affichage (10), est axialement mobile sur un axe de translation (R) et qui comporte une deuxième échelle de dosage (Z) s'étendant dans l'axe de translation (R) pour l'affichage de la dose dans des deuxièmes graduations d'échelle, le premier élément d'affichage (10) tournant relativement au deuxième élément d'affichage (12) autour d'un axe de rotation (R) ou étant axialement mobile l'axe de translation (R).
PCT/EP2008/057039 2007-06-08 2008-06-05 Dispositif d'administration doté d'un élément d'affichage axialement mobile WO2008148864A1 (fr)

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DE102007026560A DE102007026560A1 (de) 2007-06-08 2007-06-08 Verabreichungsvorrichtung mit axial beweglichem Anzeigeglied
DE102007026560.5 2007-06-08

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