WO2011057677A1

WO2011057677A1 - Administering device having overload protection during dose adjustment

Info

Publication number: WO2011057677A1
Application number: PCT/EP2009/065255
Authority: WO
Inventors: Aurèle HORISBERGER; Patrick Hostettler; Malte Kladiwa; Stefan Meier; Peter Stettler; Jürgen Wittmann
Original assignee: Tecpharma Licensing Ag
Priority date: 2009-11-16
Filing date: 2009-11-16
Publication date: 2011-05-19

Abstract

The invention relates to an administering device for administering a preferably liquid medication, comprising a coupling (13) having a coupling input element (13a) and a coupling output element (13b), wherein the transmission of an input torque applied to the coupling input element (13a) to the coupling output element (13b) can be limited by means of the coupling (13).

Description

Delivery device with overload protection at dose setting

The invention relates to a coupling for an administration device for administering a preferably liquid or fluid product with a metering device for adjusting a dose amount of the product to be administered, in particular an injection device for a product administration to humans or animals.

A wide variety of fluid medical, pharmaceutical or cosmetic products must be administered subcutaneously in order to be effective. For this purpose, various administration devices are known, which are operated by a user himself or by a medical assistant for administration. For example, diabetes patients must be given insulin at regular intervals. As a rule, the insulin is injected by the patient himself with a delivery device. The fluid product is stored in the delivery device in a product container, such as a carpule. A discharge of the product from the product container takes place by the advancement of a piston in the product container by means of the discharge device. To adjust a dose level of the product to be administered, some delivery devices are equipped with a dose setting device that adjusts a desired dose level prior to injection. The set dose level of the product may be dispensed from the delivery device by means of a dispenser.

To set the dose to be administered, a rotary movement about the longitudinal axis can be performed on a dose setting element. The individual parts of the mechanism are moved to the position corresponding to a desired dose quantity. For most delivery devices, the paths of the dose adjuster are limited. On the one hand, because an injection should not administer more than the amount that makes medical sense. For another, because after several administrations only still a limited amount is available in the product container. To limit the dose setting a dose stop is usually provided.

When setting the dose, forces acting within the dose setting device that have a detrimental effect on the entire mechanics, as soon as the dose stop is reached and the user tries to override the stop by force. On the one hand, this damage can lead to complete destruction of the mechanism and, on the other hand, to an inaccurate setting of a dose. In particular, when the mechanism is constructed of both plastic parts, as well as metal parts, the action of excessive forces can adversely affect the individual parts. To remedy this problem, it is known to design the affected parts accordingly stable, whereby the size of the injection device tends to increase.

From WO 2004/020027 an overload protection for the metering mechanism of a product dispenser is described. A slip clutch acts as an overload protection in the event that too much torque is applied to the dosing mechanism by the dosing button. If a predetermined limit torque is reached, the dosing knob is decoupled from the transmission element, whereby further rotation of the dosing button does not damage the dosing mechanism. For the user of the product dispenser, it is not always clear whether the desired dose has already been set, whether the mechanism is damaged or whether he must turn the dosing knob further.

It is an object of the invention to provide an administering device for administering a fluid product which is handy and sturdily constructed.

This object is achieved by an administration device according to claim 1. Advantageous developments emerge from the dependent claims.

The invention is based on a coupling for or in an administration device for administering a preferably liquid product, in particular a medicament, such as, for example, insulin. The clutch comprises a clutch input member and a clutch output member, wherein with the clutch, the transmission of a on the Clutch input member exerted input torque is limited to the coupling output member.

The input torque may be the torque that is passed into the clutch. The input torque may be that exerted by the user, in particular on an element graspable by him, such as a Doseinstellelement, or exercisable torque, which, in particular as the input torque, preferably acts around the longitudinal axis of the device. In particular, the clutch input member may be rotatably connected to the dose setting, so that the clutch input member with the torque that the user exerts on the dose setting, can be acted upon. For example, the dose setting member and the clutch input member may be two separate parts that are indirectly connected, such as over another part, or directly, such as with at least rotationally fixed and optionally axially displaceable or axially fixed engagement. Preferably, the clutch input member may be the dose setting member, i. the coupling input element and the dose setting element form or act at least one part.

The dose setting member, which may be particularly sleeve-shaped, may have on its outer periphery a surface provided with a structure such as a knurl or longitudinal grooves to reduce slippage between the user's fingers and the dose setting member. Preferably, the dose setting is rotatable relative to the housing and axially connected to the housing. Optionally, the dosage setting member may also be rotatable and axially movable, in particular screw-mounted on the housing.

The output torque may be the torque that delivers the clutch toward a metering member. The coupling may be arranged kinematically between the dose setting element and the dosing member and / or be part of a dosing drive train. The output torque may preferably act around the longitudinal axis of the device.

The coupling can advantageously form an overload protection between the dosing member and the dose setting element. With appropriate design of the coupling can thus the Input torque no damage to the parts, which has the Dosierantriebsstrang, such as arise on the dosing. The parts can thus be made less strong, since the maximum load, which essentially corresponds to the maximum output torque, in the design, ie in the design of the clutch is predictable.

The limitation of the transmission of the input torque to the clutch output member can be made from a limit torque which is greater than zero and in particular is so high that the parts of the Dosierantriebsstrangs are to be protected against even higher loads. For example, with the clutch maximum output torque in the amount of the limit torque can be delivered. Preferably, up to the level of the limit torque, the input torque to the clutch output member transferable, in particular without appreciable, i. with no or negligible slip between the clutch input member and the clutch output member. From the limit torque, the torque transmitted to the clutch output member is less than the input torque, and the transmitted torque, i. Output torque can assume a value between zero and substantially the limit torque. The coupling is expediently designed so that the limit torque is at least so high that with it an output torque is deliverable, which is sufficient to achieve the required effect in the output side arranged mechanism, such as a dose setting.

Preferably, the clutch is a self-actuated clutch, wherein the self-actuation is particularly dependent on a torque. When the input torque of the clutch reaches the level of the limit torque, the clutch operates by itself, ie, except for the application of the input torque, without external intervention, whereby the clutch automatically limits the torque delivered to the clutch output member. A simple example of a self-actuable clutch is one Coupling in which a part which can withstand only a limited load is destroyed, such as a shear bolt or a predetermined breaking point. Another example of a self-actuatable clutch is a clutch in which the clutch input member and the clutch output member are coupled via a frictional engagement. Such a clutch may generally be referred to as a friction clutch. The frictionally engaged connection has a positive locking effect until the limit torque is reached and sliding frictional engagement from the limit torque. For example, the clutch input member may be rotated at any angle relative to the clutch output member when the input torque exceeds the limit torque or the output torque. The coupling may in particular be a multi-plate clutch or friction-friction clutch and / or purely frictionally engaged, ie without a positive connection between the clutch input member and the clutch output member. The coupling output member and the clutch input member can be pressed against each other with a fixed force, such as spring loaded.

Yet another preferred example of a self-actuable coupling is a coupling having a locking body, also referred to as a switching member. The switching member is a part which can move relative to the coupling input member and the coupling output member, in particular a separate part, wherein the switching member can be formed or fixed in principle via a flexible means on a coupling input member and coupling output member. The switching element may preferably engage positively in each case in the coupling input member and the coupling output member, in particular in the unactuated state of the coupling. The switching member rotatably couples the clutch input member and the clutch output member in the unactuated state, so that the input torque is transmitted from the clutch input member, in particular via the switching member to the clutch output member. The switching element is kinematically preferably between the clutch input member and the clutch output member.

Upon reaching the limit torque, ie upon actuation of the clutch, the switching member can be moved relative to at least one of the clutch input member and the clutch output member. In particular, when reaching the limit torque, the switching member of the clutch input member and / or of the Clutch output member are at least partially pushed out of engagement with the clutch input member or the clutch output member or pushed out of engagement with the clutch input member or the clutch output member or that the clutch input member is rotatable relative to the clutch output member, at least by a few degrees. For example, the clutch input member may be rotatable in a rotational direction at least or only so far relative to the coupling output member until the switching member is displaced. After moving the switching member, the clutch input member and preferably also the dose setting member is locked relative to the housing in one direction of rotation and not in the other. Alternatively, in the actuated state of the clutch, the clutch input member or dose setting member may be rotatable in both directions of rotation, although less preferred. Preferably, the switching member, the clutch input member and / or the clutch output member may be formed so that the switching member is displaced upon reaching the limit torque. For example, upon reaching the limit torque, the clutch input member or the clutch output member may rotate relative to the shift member. In particular, the engagement of the clutch input member with the shift member may be permanent, ie not be releasable, and the engagement of the shift member in the clutch output member be at least partially releasable, so that the clutch output member can perform a rotational movement relative to the switching member. It can also be provided the reverse case, that the switching element forms a permanent engagement with the coupling output member. Preferably, the switching member is pressed by the engagement pair of the switching member with the coupling output member out of engagement with the coupling output member. In preferred embodiments, the coupling output member may have at least one recess, in which engages the switching member. The recess may, for. B. have an edge on which the switching member can slide, so that it is at least partially or completely pushed out of engagement with the recess. The switching element may be displaceable with a movement transversely, in particular radially, or longitudinally, in particular parallel to the axis about which the input torque is applied. Accordingly, the flank of the recess can also be arranged. The switching element may have a corresponding to the flank of the recess counter-flank so that it better on the edge of the Can slide recess. The recess may have only a single edge, so that the switching member is moved only in one direction of rotation of the coupling input member. Optionally, the recess may have a second flank, which allows a displacement of the switching member when the clutch input member is rotated in the other, ie opposite direction of rotation and in particular a limit torque is achieved in the opposite direction of rotation. The limit torque in one direction of rotation may be different than the limit torque in the other direction. Preferably, the limit torques are the same in both directions of rotation. This can be achieved, for example, if the flanks of the recess are inclined to different degrees (different limit torques) or equal (same limit torques). It is generally preferred that the coupling of the transmission of the input torque to the clutch output member in both directions of rotation of the clutch input member is limited. For example, a single switching element may be provided for a single or a plurality of recesses. Alternatively, at least one switching element, in particular a plurality of switching elements may be provided which each engage in a recess.

Preferably, a spring element is provided for the switching element, which presses the switching member into engagement with the recess. Preferably, the limit torque depends at least on the slope of the edge and the spring force of the spring element. In particular, the limit torque may additionally be dependent on the coefficient of friction between the switching element and the flank of the recess or / and on the height of the flank. It goes without saying that the flank is inclined so that no self-locking occurs between the flank and the switching element. By a suitable choice of the spring force, the inclination of the flank and the friction pair, the limit torque can be set in a simple manner during the construction of the coupling , The spring element may be a helical spring such. B. metal or plastic, or be an arm at the end of the switching element is formed or arranged.

In a particularly preferred embodiment, with the switching member, the input torque at least partially, preferably the limit torque excessive proportion, in a housing or a housing-fixed element of the administering device be conductive. The housing-fixed element is at least rotationally fixed, preferably also axially fixed to the housing. When the limiting torque is reached, the switching element can be moved into an engagement, preferably in at least one direction, in a rotationally fixed engagement with the housing. In particular, the rotationally fixed engagement blocks a rotation in the direction of rotation in which the input torque is applied, which leads to the actuation of the clutch. The torque exerted on the clutch input member is at least partially conducted into the housing via the switching member, optionally via the housing-fixed member. As a result, on the one hand, the downstream of the switching member in the dosing strand parts are protected from overloading and on the other hand, a further rotation of the clutch input member and preferably also of the dose setting is prevented in a rotational direction. By this means, the user of the device notes, in contrast to a dose setting, which can rotate arbitrarily far in overload relative to the coupling output member, a defined rotation stop.

The engagement of the switching element in the housing or the housing-fixed element is preferably form-fitting. For example, the housing or the housing-fixed element, a stop, which preferably acts in the circumferential direction and therefore may be referred to as a rotation stop, have. In particular, upon reaching the limit torque, the switching member is moved to a position in which it is rotatable against the stop. If the input torque is less than the limit torque, the switching member is preferably in a position in which it is not rotatable against the stop. The switching member may preferably be moved past the rotation stop in such a position. For example, the switching member can be moved to a position in which it is in alignment, in particular a circular path escape with the stop. On the switching element adapted for the stop counter-stop can be formed or arranged. The stop may be the flank of a recess formed on the housing or the housing-fixed element. Preferably, over the circumference of the housing or the housing-fixed element more, z. B. evenly spaced stops and possibly recesses provided for the switching element. This stop can z. B. act in a first direction of rotation. For example, at least one further stop can be provided, which forms a rotation stop in the second direction of rotation, ie the direction of rotation opposite to the first direction of rotation. This stop can z. B. from the first edge opposite edge of the recess or another depression may be formed.

Particularly preferably, the switching element is resiliently arranged and movable against the spring force in the preferably positive engagement with the housing or the housing-fixed element. In particular, the switching member along or transverse to the axis about which the input torque is applied, from a position in which the switching member is not movable against the stop, movable to the position in which the switching member is movable against the stop.

In preferred embodiments, the clutch input member and / or the clutch output member and / or the switching member is shaped, in particular provided with a Getriebefiäche that the switching member is displaceable by means of a relative movement between the clutch input member and the clutch output member. For example, the clutch input member forms a longitudinal guide, with which the switching member is permanently in a rotationally fixed engagement, wherein the switching member along the axis about which the input torque is applied, relative to the clutch input member is displaceable. Alternatively, the clutch input member may comprise a radial guide, with which the switching member is preferably permanently in a rotationally fixed engagement, wherein the switching member is movable with a movement radially to the axis about which the input torque can be applied. If the rotation in one direction of rotation is blocked in the dosing line below the coupling output member, the coupling output member preferably also blocks in this direction of rotation. Thereby, the switching member, which is acted upon via the clutch input member with the input torque, slide on the clutch output member, which provides the reaction torque for the input torque.

It is generally preferred that the coupling output member has a toothing, in which the switching member engages positively, wherein the clutch input member in a positive, in particular rotationally fixed engagement with the switching element. The input torque can be conducted via the switching element to the coupling output member. Upon reaching the limit torque, the switching member may slide on the clutch input member and / or the clutch output member by the force exerted by the clutch input member on the switching member and the force exerted by the clutch output member on the switching member reaction force.

The dosing member may comprise a part whose position relative to the housing determines the set dose amount and / or the length of a delivery stroke.

In preferred embodiments, the dosing member may alternatively or additionally comprise a dose indicator member which is directly or indirectly connected to the coupling output member and which may in particular be configured as a dose display drum. Preferably, the dose indicator is rotatable relative to the coupling output member and in particular axially displaceable.

The dose indicator member may have a preferably several revolutions circumferential scale from which through a window in or a mark on the housing the set product dose is readable. The dose indicator member may have an internal or external thread, which preferably engages in the housing or in a housing-fixed member and in particular has the same pitch as the helical circumferential scale. The dose indicator drum may be movable between a proximal end position and a distal end position, wherein in one end position the maximum adjustable dose and in the other end position the dose 0 is displayed. The value 0 is preferably displayed in the distal end position of the dose display drum. The end positions can each be formed by an end stop. The end stops may be stops acting in the axial direction or preferably stops acting in the direction of rotation, which counteract directly the rotational movement of the dose display drum. Depending on the indicated dose, the end positions of the dose indicator may be referred to as the zero dose position and the maximum dose position. The Dosieranzeigeglied can be configured, for example, as that of document DE 10 2008 011 881 AI, to which reference is made for advantageous developments. Optionally, the dose indicator may be a first dose indicator operatively connected to a second dose indicator. For example, the first dose indicator may have a one-revolution scale, which preferably shows the numerical values from 0 to 9 in one-step increments. The second dose indicator member may be a non-rotatable and longitudinally displaceable member relative to the housing of the device, which may have numerical values in increments of 0 to 6 or 8 or 9, for example. Preferably, the numerical values of the first dose indicator are ones of a two-digit dose value that can be displayed by the combination of the first and second dose indicator. The dose value is preferably readable in a window of the housing. The numerical values of the second dose indicator are preferably tens. In particular, the first dose indicator is coupled to the second dose indicator such that upon a full rotation of the first dose indicator, the second dose indicator is translated by such a path along the longitudinal axis of the device that the next adjacent value above or below the pre-shift value is combined with a value is displayed on the first dose indicator. For example, the second dose indicator member may engage a guideway formed by, for example, the first dose indicator member or a separate barrel member which is preferably non-rotatably connected to the first dose indicator member. In particular, the guide track may be formed on the outer circumference of the dose indicator member or the drum member. The guideway of the combination of the first dose indicator, the second dose indicator and optionally the barrel member, which may be generally referred to as a dosing member or as part of the dosing member, may for example be moved between a maximum dose position and a zero dose position, with an engaging member formed on the first dose indicating member at the end of the guideway a rotation stop strikes. Alternatively, the second dose indicator may strike an axial stop, for example, of the housing in a zero dose position and / or maximum dose position. Also in this embodiment, the rotation in the zero dose position is blocked in one direction of rotation and in the maximum dose position in the other direction of rotation in the dosing strand below the coupling output member. The dose indicator members can be designed, for example, as described in document DE 10 2007 026 560 A1, to which reference is made for advantageous developments. The doser, in preferred embodiments, may alternatively or additionally comprise a mechanism for preventing the setting of a dose exceeding the amount of drug contained in a product container of the administering device, the dose being adjusted by rotating the dose setting element, the mechanism being a limiting member having rotationally fixedly coupled to the coupling output member drive member and an acting on the product container output member. The limiting member is preferably coupled to the drive member and the driven member such that relative rotation between the drive member and the driven member forces the limiting member to move toward a stop position at a dose setting, the limiting member preventing the setting of a dose representing the amount exceeds the drug contained in the product container. The drive member may be a separate part or be formed by the coupling output member. Preferably, in the dose setting, the drive member is rotated relative to the output member, wherein in the dose distribution, the drive member and the output member are rotationally fixed. As a result, the limiting member is moved in the direction of stop position at a dose increase and moved away from the stop position at a dose reduction in the dose setting. As a result, the limiting member counts the distributed dose amount and the currently set dose together, whereby preferably the sum formed therefrom does not exceed the product quantity contained in the product container. In the stop position of the limiting member, the limiting member abuts against a stop, which is preferably formed as a rotation stop, on, whereby at a dosage, the rotation of the drive member is prevented relative to the driven member. But this also means that the coupling output member can not turn. If the torque is increased to the dose setting to the limit torque of the clutch, that is, trying to turn the dose setting further, the clutch operates itself, causing destruction z. B. the limiting member is prevented because the excess torque z. B. is derived in the housing. The limiting member may, for. B. may be a nut having an internal thread and a longitudinal guide on its outside. The longitudinal guide can z. B. in a corresponding longitudinal guide, which is attached to the inside of the dose indicator, engage, whereby the limiting member relative to the dose indicator member is rotationally fixed and longitudinally displaceable. The limiting member can with its thread directly into a thread z. B. a piston rod or with the piston rod rotatably and longitudinally displaceable connected intermediate or rotary sleeve engage. The output member may comprise at least one of piston rod and rotary sleeve. In preferred embodiments, with the clutch, the transmission of the input torque applied to the clutch input member to the clutch output member may be limited to only at least one of the zero dose position, the maximum dose position of the dose indicating member, and the stop position of the limiting member. A preferred device may therefore comprise a dose indicator and a limiting member. If the maximum dose is less than the amount of product contained in the product container, the dose indicator member may be rotated to the maximum dose limit stop, thereby blocking the dosing line. If the maximum dose exceeds the amount of product contained in the product container, the limiting member comes to its stop position, whereby the dosing line is also blocked in one direction of rotation. When the dose indicator is moved toward the zero dose position, the zero dose position end stop blocks the movement of the metering drive train in the opposite direction of the metering movement. In the device, therefore, the rotational movement can be blocked in three positions. In the states mentioned, the coupling can in each case prevent overloading of the parts arranged downstream of the coupling output member.

The blocking of the dose setting element is preferably detachable and acts in particular only in the direction of rotation which has led to actuation of the clutch. A reduction of the input torque below the limit torque or a reverse rotation results in the release of the lock. Despite blocking in one direction of rotation, the dose setting element is generally preferably rotatable in the opposite direction.

Preferably, a drive member may be arranged kinematically between the dosing member and the coupling output member. The drive member may be rotatable relative to the output member at the dose setting, while it is rotatably coupled to the output member in the dose distribution. In particular, the drive member may be an additional coupling, such. B. a part of a dog clutch, which rotatably coupled to the output member for dose distribution with the drive member. The drive member is preferred rotatably and axially displaceable, in particular by means of a longitudinal guide, connected to the dose indicator.

Alternatively or additionally, a torsion spring drive can be provided for a product discharge, which can be tensioned by rotating the dose setting element, in particular to increase the dose. In order to avoid overstressing the torsion spring drive, the clutch according to the invention can also be used.

The invention can be particularly preferably used in devices as described in DE 10 2008 011 881 AI or DE 10 2007 026 560 AI.

An example:

A preferred and exemplary administering device may include a housing, a dose-setting member movable relative to the housing for adjusting a dose of the fluid product to be administered, a metering device received by the housing with a metering member, and a coupling between the dose-setting member and the metering member being unconfirmed , in particular completely coupled state transmits an adjustment movement of the dose setting on the dosing include. In the housing, a product container for the fluid product may also be housed, in particular, this may be connected to the housing. In the product container is z. B. a piston is provided, which seals the product container and is moved to the distribution of the product. The product can be distributed by means of a dispensing mechanism via a hypodermic needle unit from the product container.

The administering device can be designed as a disposable device or as a reusable device. In disposable devices, the entire administration device is disposed of as soon as the product container is completely emptied or no further administration is required. In reusable devices, the housing typically consists of multiple housing parts that can be separated from one another to replace a deflated product container with a new, filled product container. Subsequently, the housing parts can be reassembled and the administering device can continue to be used. The dosage setting member of the administering device may be movably mounted on the housing or partially stored in the housing. A user of the delivery device grasps the dose setting element and can adjust a desired dose level of the fluid product by moving the element relative to the housing. For this purpose, the administration device preferably has a dose indicator element from which a currently set dose quantity can be read. The dose display can be done for example by a sequence of numbers, by strokes or by colors. The dose setting element can be rotatably mounted on the housing for adjusting the dose. Alternatively, however, it is also possible for the dose setting element to be displaced axially along the longitudinal axis of the housing or the administering device, for example pulled out of the housing or unscrewed. The metering device has a metering member which is mounted movably relative to the housing. The adjustment movement of the dose setting element is transferred to the dosing member so that it is moved relative to the housing according to a desired dose amount. The dosing member may for example be a threaded nut which is moved on a threaded rod and thereby moves in the axial direction relative to the housing according to a desired dose. The position of the dosing relative to the housing determines the set dose amount. The dosing member may preferably determine the length of a delivery stroke of the piston in the product container.

For example, the threaded rod, on which the threaded nut is arranged, serve as a feed rod for the piston in the product container. In this case, the threaded nut is moved on the threaded rod relative to a Ausschüttanschlag and the distance between the threaded nut and Ausschüttanschlag defines the Ausschütthub.

However, it is also possible that the dosing engages in a rack which serves as a feed element of a Ausschütteinrichtung. The axial movement of the dosing on the rack relative to the housing determines the delivery stroke and thus the set dose amount. The metering device can have at least one dose stop against which the metering member strikes when setting a maximum or minimum dose amount. The dose stop can be formed for example by a housing-fixed edge, a projection or a blind groove. The dose stop can limit the movement of the dosing member relative to the housing, so that no dose quantities can be set which are greater than the mechanics of the metering device allows. This can prevent overdosing or prevent incorrect dosing, which could occur due to a limited amount of product in the container. For example, the rotational movement of the metering threaded nut can be stopped on a threaded rod by the stop of the nut on a fixed part of the housing.

Likewise, for example, when correcting a too large selected dose, i. H. a setting movement to reduce the dose possible that the dosing abuts a dose stop, which corresponds to a minimum dose amount. The minimum dose amount may also be a zero dose.

In a dosing, which is due to the adjustment movement of the dose setting relative to the housing z. B. moves in an axial direction, ie z. B. for setting larger doses in the proximal direction and for setting smaller doses in the distal direction, at least one proximal dose stop and at least one distal dose stop can be provided.

The self-actuated coupling between the dose setting element and the dosing member transmits in its unactuated, in particular fully coupled state an adjustment movement of the dose setting on the dosing. It is in principle possible for the dose setting element to act directly on the dosing member through the coupling or for the setting movement to be transmitted to the dosing member via further elements of the dosing device. It is crucial that in the unactuated state of the clutch by the movement of the dose setting a desired dose amount can be set on the dosing of the metering device. In an actuated, in particular decoupled state of the clutch is an adjustment movement of the dose setting not transferred to the dosing unit. In the actuated state, the dosing remains in spite of an adjustment on the dose setting at rest.

The exemplary administering device has at least one housing-fixed adjustment stop, which blocks a setting movement of the dose setting when the clutch is actuated, in particular in an at least partially decoupled state. However, if the clutch in the unactuated state, there is no blocking of an adjustment movement of the dose setting. Accordingly, the dose setting element is rotatable relative to the housing in the unactuated state of the coupling in order to be able to set a dose quantity of the fluid product to be administered. However, if the clutch is in the actuated state, the dose setting element or the switching element of the coupling abuts against the at least one housing-fixed adjustment stop and a dose setting movement of the dose setting element in one of the two directions of rotation is not possible. The clutch changes from the unactuated state to the actuated state as soon as a torque in the amount of the limit torque is applied to the dose setting element, so that the dosing member abuts or is pressed against the at least one dose stop by a force predetermined by the limit torque. The force is exerted by the adjusting movement of the dose setting on the dosing and transferred from the dosing to the dose stop.

It is therefore possible for a user to immediately recognize whether a maximum or minimum possible dose amount has been set, since in this case the dose setting element is blocked via the setting stop fixed to the housing and can not be moved further at least in one direction of rotation. If, nevertheless, a force is applied by an attempted rotational movement on the dose setting element, this force or torque is transferred to the setting stop fixed to the housing and no longer to the dosing member. The housing-fixed adjustment stop can be given by a projection, an edge or a recess on the housing itself or on a firmly connected to the housing component. Destruction or damage to the delivery device due to excessive torque in the dose setting is avoided. The clutch input member of the clutch may be fixedly connected to the dose setting member or integrally formed with the dose setting member. Preferably, the switching member is axially movable along a longitudinal axis of the administering device or the dose setting and rotatably mounted on the dose setting. The longitudinal axis preferably corresponds to the longitudinal axis of the housing, which is generally formed sleeve-shaped. For example, the switching member may be at least partially movable in a longitudinally extending guide rail of the dose setting member along the dose setting member. Alternatively, it is also possible to arrange the switching element as a flexible member at a location of dose setting. The switching element is then z. B. flexibly deflectable or bendable relative to the dose setting.

The coupling output member of the coupling is preferably provided on a drive member of the metering device for driving the metering member at a dose setting. In this case, a dose setting movement of the dose setting is transmitted via the coupling to the drive member of the metering device. In principle, however, it is also possible that further elements are provided between the coupling output member and the drive member or between the drive member and the dosing member, which transmit the adjustment movement of the dose setting on the dosing. It is also possible to provide an over- or reduction of the adjustment movement relative to the movement of the dosing.

The coupling, such. B. in the form of a slip clutch, is preferably designed such that the clutch input member and the clutch output member in the unactuated state of the clutch frictionally engage, in particular frictionally engaged. Due to the non-positive engagement, the dose adjustment movement is transmitted to the dosing member. As soon as the limit torque is reached for the dose setting movement, the clutch input member and the clutch output member slide on each other, whereby the clutch is actuated. Once the clutch input member and the clutch output member have moved or moved relative to each other, the dose setting comes into abutment with the setting stop, directly or indirectly via other components, such. B. the switching element of the administering device. In the following, preferred embodiments of the invention will be described with reference to figures. The features disclosed in this case individually and in any combination, the invention advantageously further. 1 shows a longitudinal section through an administration device with a coupling according to a first embodiment;

an exploded view of the administering device of Figure 1; a perspective view of a portion of the delivery device of Figure 1 in an unactuated state of the clutch;

perspective view of a part of the administering device of Figure 1 in an actuated state of the coupling; and

a cross-sectional view of a coupling according to a second embodiment.

Figures 1 to 4 show an administering device or at least parts thereof with a coupling 13 according to a first embodiment of the invention. The administration device comprises a housing 5, to which the product container holder 3 can also be counted in the broader sense, which is detachably or non-detachably connected to the housing 5. The product container holder 3 receives a product container 2, which in this example is designed as a carpule. Alternatively, the product container 2 could be a syringe which, unlike the carpule, has an injection needle fixedly connected to the product container 2. On the product container holder 3, an injection needle unit 1 is detachably arranged, wherein the injection needle pierces a septum of the carpule and thus produces a fluid connection to the interior of the product container 2. The product container 2 supports a piston 9, which is displaceable in the product container 2 in the distal direction or delivery direction and sealingly abuts against the inner wall of the product container 2, so that the piston 9 displaces the product via the needle from the product container 2 in a movement in the delivery direction. In this example, a cap 4 at the distal end of the administering device and a needle cap are attached to the needle unit 1, which are detachable.

From the housing 5, a driven member 8 is received in the shape of a piston rod. The output member 8 has an external thread, which in a Internal thread of the housing 5 engages. By rotation of the output member 8, this is moved along the longitudinal axis of the administering device, so that by rotation of the output member 8, the piston 9 is slidable in the discharge direction. The output member 8 has at its periphery at least one longitudinal guide, in which a rotary sleeve 18 rotatably engaged, wherein the piston rod 8 is movable relative to the rotary sleeve in the longitudinal direction. In a broader sense, the rotary sleeve 18 and the piston rod 8 can be regarded as a driven member. The rotary sleeve 18 has at its outer periphery an external thread into which an internal thread of a limiting member 15 engages. The limiting member 15 is designed as a nut and has at its outer periphery Abragungen, which engage in longitudinal grooves which engage on the inner circumference of a dose display drum 14. The limiting member 15 is rotatable relative to the dose display drum 14 and axially displaceable.

The dose indicating drum 14 has on its outer circumference a helically extending scale whose pitch corresponds to a helical groove also formed on the outer periphery. The helical groove, which may also be referred to as a thread, engages with the housing 5 so that the dose indicating drum 14 can be screwed back and forth between a distal end position and a proximal end position. In the end positions, the movement of the dose indicating drum 14 is limited by rotational stops formed on the dose indicating drum 14 which abut against corresponding counterstops of the housing 5. By a reading window (not shown) in the housing 5, the currently set dose value can be read from the scale of the dose display drum 14. The dose indicating drum 14 enters a rotational stop in one of the two end positions, also referred to as the maximum dose position, and in the other of the two end positions, also referred to as the zero dose position. In the maximum dose position, the maximum value of the dose that can be administered with the administering device can be read. In the zero dose position the value 0 is readable. Rotationally and axially movable, such. B. via longitudinal guides, a drive member 12 is connected to the dose display drum 14. The drive member 12 has a coupling 19 which is drawn in Figure 1 in a disengaged state and the z. By protruding at the proximal end of the delivery device Actuator 7 is axially displaceable in the distal direction, whereby it rotatably coupled to the drive member 12 and the rotary sleeve 18.

On the drive member 12, an energy storage means 20 is fixed, which acts as a torsion spring. The torsion spring can be a helical spring or a watch spring or band-shaped helical spring, as shown in FIG. The energy storage means can be wound up by rotating the drive member 12, i. H. be charged with energy, wherein the energy storage means 20 in turn can deliver the energy to the drive member 12, in particular for driving the output member 8, 18 for a product distribution.

A rotatable element 6, which is rotatable and axially fixed relative to the housing 5, is indirectly, namely via a coupling 13, connected to the drive member 12, with the element 6 on the one hand a product dose to be administered is adjustable and on the other hand, the energy storage means 20 with torsional energy can be charged. For dose setting and for charging the energy storage means 20, the element 6 is rotatably connected to the drive member 12. In devices in which the element 6 serves only for mounting an energy storage means 20, it may be referred to as Aufziehelement. In devices in which a dose is adjustable with the element 6, it may be referred to as dose setting element 6. In the device of FIGS. 1 to 4, the element 6 serves as a dose setting element and will therefore also be referred to below in the following, with the dose setting element 6 also being able to supply the energy storage means 20 with energy.

To set the desired product dose, the dose setting element 6 is moved relative to the housing 5 in a first direction of rotation, which causes an increase in the dose. The dose display drum 14 is moved in the direction of maximum dose position. If the dose amount contained in the product container 2 is greater than the maximum adjustable dose, the dose indicating drum 14 may be moved to the maximum dose position where the dose indicating drum 6 abuts the housing 5. It is also possible to dose the set dose by rotating the dose setting element 6 in the direction of rotation opposite to the first direction of rotation, ie the second direction of rotation. Here is the Dose indicating drum 14 moves in the direction of the zero dose position, wherein the dose indicating drum 14 abuts the housing 5 in the zero dose position.

Is in the product container 2 contains a quantity of product which is less than the maximum dose generally adjustable with the device, device during dosing, d. H. when turning the dose setting 6 in the first direction of rotation, the limiting member 15 at a currently set dose corresponding to the remaining amount contained in the product container 2, in its stop position in which it abuts the dose display drum 14, the rotary sleeve 18 or the drive member 12. For this purpose, the limiting member 15 and the dose display drum 14, the rotary sleeve 18 or the drive member 12 each have a stop, which abut stops in the stop position and in particular as a rotational stops, d. H. are designed in the direction of rotation stops. As a result, a rotation of the dose indicating drum 14 necessary for the dose adjustment is blocked relative to the piston rod 8 or the rotary sleeve 18. A rotation of the dose setting 6 in the first direction of rotation is then no longer possible, but only a rotation in the second direction of rotation, d. H. for dosing.

Without the coupling according to the invention, the device could be overloaded, namely by an excessive torque applied to the dose setting element 6. Overload would be z. In the following situations: in the zero dose position in attempting to rotate the dose setting element in the second direction of rotation; in the maximum dose position, in an attempt to rotate the dose setting member in the first direction of rotation; in the stop position of the restricting member 15, in an attempt to rotate the dose setting member 6 in the first rotational direction; and / or when mounting the energy storage means 20 upon rotation of the element 6 in the first direction of rotation, if the energy storage means 20 would be exposed to an excessive load, such. B. if the spring 20 would be mounted over a permissible value.

In order to avoid the above overloading, according to the invention, a coupling 13 is kinematically inserted between dose setting element 6 and drive member 12. The clutch 13 comprises a clutch input member 13 a, a clutch output member 13 b and a switching member 13 c. The clutch input member 13a is in this example on the Dose setting 6 formed, ie dose setting 6 and clutch input member 13 a are one piece. The coupling output member 13b is rotatably connected to the drive member 12, wherein the drive member 12 is axially displaceable relative to the coupling output member 13b. The switching member 13c is rotatably and axially slidably connected to the clutch input member 13a.

The annular switching member 13c has on its facing the coupling output member 13b end face a plurality of evenly distributed over the circumference of teeth 13d, which form a toothing and engage correspondingly formed recesses 13f of a counter toothing formed on the switching member 13c facing end face of the coupling output member 13b are. The recesses 13f of the coupling output member 13b and the teeth 13d of the switching member 13c engage each other in a form-fitting manner. The switching member 13c is pressed or held in engagement with the coupling output member 13b by a plastic spring 11 designed as a compression spring and acting in the axial direction. A rotation of the dose setting element 6 is transmitted to the drive member 12 via the positive engagement of the switching member 13c in the coupling output member 13b. If one of the above situations occurs for an overload, d. H. when the input torque applied to the dose setting member 6 becomes larger than a predetermined limit torque of the clutch 13, the shift member 13c slides on the flanks of the recesses 13f of the clutch output member 13b, whereby the shift member 13c makes axial movement, namely movement in the distal direction against the force the spring 11 executes. The switching member 13c is pressed by the axial movement from a position that it occupies in an unactuated state of the clutch 13 (Figure 3) in a position in which it with a rotation stop 10, which is formed by the housing 5 in a stop device (Figure 4). As a result, further rotation of the dose setting in the direction of rotation, which would generate an overload prevented. The input torque is at least partially, in particular derived with the above-limit torque share in the housing 5. The kinematically downwards the clutch 13 lying parts 12, 14, 15 are thus protected from overloading.

The rotation stops 10 are formed by flanks of a plurality of recesses 5 a, which are arranged uniformly over the circumference of the housing 5. The plurality of recesses 5a preferably forms part of a dog clutch 5a, 13e. To the jaw clutch 5a, 13e include corresponding counter jaws 13e, which are designed as Abragungen and arranged on the facing in the direction of discharge end face of the switching element 13c. The switching member 13c has at its pointing in the direction of discharge end face a plurality of such projections 13e uniformly distributed over the circumference, which can engage in the recesses 5e, the flanks of which form the rotation stops 10. The switching member 13c is thus part of a dog clutch 5 a, 13 e, which engages only in case of overload, ie at an input torque which is greater than the limit torque, and otherwise disengaged. The depressions 5e have the same or a multiple of the pitch with which the projections 13e are divided over the circumference.

As an alternative to the coupling 13 shown in FIGS. 1 to 4, the coupling 13 shown in FIG. 5 can be used in the described administering device. The parts of the coupling 13 of Figure 5, which are denoted by the same reference numerals as the parts of the coupling of Figures 1 to 4, perform substantially the same task as the parts of Figures 1 to 4. The clutch input member 13a is non-rotatable with the dose setting 6, is sleeve-shaped and has a plurality of evenly distributed over its circumference openings, in each of which a switching member 13 c is arranged. The apertures of the coupling input member 13a form a guide for the respective switching member 13c, with which the switching member 13c transverse to the longitudinal axis, ie in the radial direction can be guided. The switching member 13c is sandwiched and guided on both sides by the coupling input member 13a with respect to the circumferential direction. The switching member 13c is resiliently disposed on an arm (not shown) which biases the switching member 13c toward the longitudinal axis or the coupling output member 13b, ie, pushes. The coupling output member 13b is at least rotationally fixed to the at least one metering member 14, 15 or the drive member 12 is connected. The coupling output member 13b is enclosed by the coupling input member 13a and has at its periphery a recess 13f for the switching member 13c. The recess 13f for the switching member 13c forms flanks on both sides, which serve as a gear surface on which the switching member 13c can slide. The switching member 13c or the tooth 13d formed thereon is conically shaped towards the coupling output member 13b, preferably at the angle at which the flanks of the recess 13f are inclined relative to each other. If, in one of the situations described above, in which an overload can take place, an input torque is applied to the clutch input member 13a which is greater than the limit torque of the clutch 13, the clutch input member 13a is rotated relative to the clutch output member 13b by a minimum amount. The clutch input member 13 a takes the at least one switching member 13 c in its rotational movement, whereby the switching members 13 c slide on an edge of the recesses 13 f of the coupling output member 13 b and thus perform a movement radially outward against the bias of the resilient arms. The switching member 13 c is moved radially outward to a position in which it is movable into engagement with the rotation stopper 10. The rotation stops 10 are formed by the flanks of a plurality of recesses 5 a formed uniformly over the inner circumference of the housing 5. The recesses form part of a radially acting claw coupling 5a, 13e. The other part of the radially acting claw coupling 5a, 13e forms the at least one switching element 13c, in particular its radially outwardly facing side, are formed on the projections 13e for the depressions 5a, which form the stops 10. The input torque is at least partially derived from the clutch input member 13a via the switching member 13c, the positive engagement of the switching member 13c in the housing 5, in particular with the proportion exceeding the limit torque in the housing 5. As a result, an overload of the metering mechanism of the administering device is also avoided.

As is generally preferred, the first and second embodiments of the clutch 13 have in common that a reduction in the input torque below a value of the limit torque or a rotation of the dose setting 6 in the direction opposite to the direction of rotation, which has led to actuation of the clutch 13, to a disengagement of the engagement of the switching element 13c or the switching elements 13c from the housing 5 and from the recesses 5a, which form the stops 10 leads. In particular, the one or more switching elements 13c or the teeth 13d formed thereon are again moved back into the position when the clutch 13 is unactuated, in particular by the force of the spring 11 or the arms. Generally speaking, the engagement of the switching member 13c in the housing 5 is releasable. LIST OF REFERENCE NUMBERS

1 injection needle unit

Product container / reservoir

3 product container holder

protective cap

5 housing

6 dose setting element

7 actuator / release button

7a footbridge

8 output member / piston rod or threaded rod

9 pistons

10 stop / setting stop

11 spring element

I Ia distal sleeve ring

12 drive member

13 clutch

13a clutch input member

13b Coupling output member

13c switching element

13d engaging member / tooth

13e pronunciation

13f recess

14 dose display drum

15 limiting member

18 rotating sleeve / driven member

19 clutch claws

0 energy storage agent / spring drive

Claims

claims

An administering device for administering a preferably liquid medicament comprising a coupling (13) having a coupling input member (13a) and a coupling output member (13b), the coupling (13) transmitting an input torque to the coupling input member (13a) to the coupling output member (13b) is limited.

2. Administration device according to the preceding claim, characterized in that up to the level of a limit torque, the input torque to the coupling output member (13b) is transferable and from the limit torque to the coupling output member (13b) transmittable torque is smaller than the input torque, in particular zero.

3. Administration device according to one of the preceding claims, characterized in that the coupling (13) is a self-actuated clutch, wherein the self-actuation is dependent in particular on a torque.

4. Administration device according to one of the preceding claims, characterized in that the coupling (13) has a switching member (13c) with which the input torque at least partially into a housing (5) or a housing-fixed element (10) of the administering device is conductive.

5. administering device according to the preceding claim, characterized in that the switching member (13 c) is arranged resiliently and against the spring force and / or in a preferably positive engagement with the housing (5) or the housing-fixed element is movable and in particular that the Switching member (13c) along, in particular parallel, or transversely, in particular radially, is movable to the axis about which the input torque can be applied.

Delivery device according to one of the two preceding claims, characterized in that the coupling input member (13a) and / or the coupling output member (13b) and / or the switching member (13c) are shaped, in particular provided with a gear surface, that the switching member (13c) by means of a relative movement between the clutch input member (13a) and the clutch output member (13b) is displaceable.

Delivery device according to the preceding claim, characterized in that the clutch input member (13a) in a direction of rotation only so far relative to the coupling output member (13b) is rotatable until the switching member (13c) is displaced.

Delivery device according to one of the five preceding claims, characterized in that the coupling output member (13b) has a toothing (13d), in which the switching member (13c) engages positively, wherein the coupling input member (13a) in a form-locking engagement with the switching member (13c) is, wherein the input torque via the switching member (13c) to the coupling output member (13b) is conductive and wherein upon reaching a limit torque, the switching member (13c) on the clutch input member (13a) and / or the clutch output member (13b) by the clutch input member (13a) force applied to the switching member (13c) and the reaction force exerted on the switching member (13c) by the coupling output member (13b).

Administration device according to one of claims 1 to 4, characterized in that the coupling input member (13a) and the coupling output member (13b) are coupled via a frictional connection, wherein the frictional connection is frictional locking until reaching a limit torque, and from the limit torque is gleitreibschlüssig , where the Coupling input member (13 a) is rotatable relative to the coupling output member (13 b) preferably at an arbitrary angle.

10. Administration device according to one of the preceding claims, characterized in that with the coupling (13), the transmission of the input torque to the coupling output member (13b) in both directions of rotation of the clutch input member (13b) can be limited.

11. Administration device according to one of the preceding claims, characterized in that the clutch input member (13a) is connected to a Doseinstellelement (6), which is tangible by the user of the administering device and with a torque, in particular the input torque acted upon.

12. Administration device according to one of the preceding claims, characterized in that the coupling output member (13b) with a dosing, in particular dose indicator member (14), in particular a dose display drum, connected between a proximal end position and a distal end position, each by an end stop be formed, is movable.

13. Administration device according to one of the preceding claims, characterized by a dosing member, in particular a dose-setting prevention mechanism which exceeds the amount of drug contained in a product container (2) of the administering device, the dose being adjusted by rotating a dose-setting member (10). 6), wherein the mechanism comprises a limiting member (15), a drive member (16) non-rotatably coupled to the coupling output member (13b) and an output member (8) acting on the product container, the limiting member (15) being connected to the drive member (16) and Output member (8) is coupled so that a relative rotation between the drive member and the output member forces the limiting member (15) at a dose setting to move towards a stop position, wherein the limiting member (15) the setting of a Prevents dose which exceeds the amount of drug contained in the product container (2).

14. Administering device according to one of the two preceding claims, wherein the coupling (13) transmits the input torque exerted on the coupling input member (13a) to the coupling output member (13b), in particular only in at least one of the proximal end position of the dose indicator member (14). , the distal end position of the dose indicator member (14) and the stop position of the limiting member (15) can be limited.

15. Administration device according to one of the preceding claims wherein a drive member (16) is arranged kinematically between a dosing member (15) and coupling output member (13b), and in particular for the dose distribution rotationally fixed to the output member (8) can be coupled.