DE112016004690T5 - Adjustment mechanism for a dosing device - Google Patents

Abstract

Adjusting mechanism for a metering device, in particular for metering pharmaceutical or therapeutic fluids, the adjustment mechanism comprising: at least four interconnected rotatable elements, wherein: at least two rotatable elements (511, 502) are rotatable in adjusting or correcting a dosage for the metering device; a first rotatable member (511) is a receiving member and having corrugations (514); a second rotatable member (502) or a third rotatable member (531) or a fourth rotatable member (560) has corrugations coupled to the corrugations of the first rotatable member; wherein the corrugations are shaped to allow rotation of the at least four rotatable members during delivery of the dose by the metering device.

Description

TECHNICAL AREA

The present application relates to devices, actuation arrangements, delivery devices and adjustment mechanisms for use, in particular in dosing, comprising applicators of pharmaceutical or therapeutic substances, such as growth hormones. In particular, these devices are suitable for reducing the set dose.

BACKGROUND

The hitherto known applicators of pharmaceutical or therapeutic substances have various adjustment mechanisms for adjusting the amount of a substance to be dosed. Some of these mechanisms make it possible to reduce the set dose. A number of examples of these types of mechanisms will be discussed below.

A European patent EP 1351732 B1 discloses a device for adjusting a dose for use with a reservoir filled with a fluid, wherein the dose adjusting device is adapted to inject repeatedly from the reservoir individually adjusted fluid doses. The apparatus includes a housing, a drive member, a spring means, a metering assembly, and a locking and unlocking device coupled to the housing for holding the device in a set position independent of the operation of the spring means.

A European patent EP 1926514 B1 discloses an injection device comprising a housing having a reservoir for a product to be injected, a drive button that can be moved in one direction after setting a dose relative to the housing to increase the dose, and in one direction to increase the dose correct, a slip clutch with a latching element and a counter-locking element, which come into a mutual positive and non-positive engagement in discrete detent positions of the housing to lock the actuating head during movement in the dose setting direction or in the dose correction direction, and a spring element having a spring force which counteracts the movement of the actuating head in at least one direction.

A Polish patent PL 211266 B1 discloses a dose correcting mechanism of an automatic applicator having a double clutch assembly for adjusting and correcting the adjusted dose with a coupling sleeve connected to a locking sleeve and to a nut, the coupling sleeve being radially connected to the locking sleeve by a control recess and a locking sleeve Projection and a driver nut by latching arms which pass through through holes of the coupling sleeve is coupled.

The PCT application WO 2006/045526 discloses a downward rotation mechanism for a torsion spring injection device for assisting in the injection of a drug dose from the injection device, the down rotation mechanism having an up rotation cam arranged to receive and engage an up rotation torsion spring, the up rotation and up rotation rotational springs being formed to cooperate during rotation of a dose setting element in a first direction to stress the torsion spring of the injection device, and to provide a down rotation cam arranged to receive and engage a downward rotation spring.

A US patent application US 2015112274 A1 discloses an injection pen for the medicament having a housing; a dose setting button; a locking device disposed in the housing and having a locking member; and a driver having at least one gearing operating with the pawl member, wherein the engagement between the pawl member and the external gearing substantially prevents the driver from being disengaged relative to the dose adjusting knob during dose setting and dose correction rotates. Engagement between the pawl member and the at least one external tooth allows the driver to rotate during an injection with the dose knob.

The PCT application WO2014033195 has a reusable drug delivery device; for selecting and dispensing a number of user-defined doses of a medicament. It comprises a housing, a cartridge holder, a piston rod, a driver, an indication of the set dose; a clutch and an adjustment knob. ratchet + locking device

The PCT application WO2015055640 has a drug delivery device with a cartridge. This has a cylindrical portion, an outlet portion and an axially displaceable piston, an outflow arrangement, a rotatable driver assembly, which allows a user to set an amount to be dosed. And to load the drive according to a spring, a locking device that allows the drive assembly from an initial position in rotated in a first direction and held in a rotational position corresponding to a set dose.

There is now a need to improve the aforementioned devices in order to overcome at least some of the problems described above and to provide alternative solutions. The problems encountered in the hitherto known devices include among others: a large number of elements, a very complicated construction, high manufacturing costs, insufficient robustness, relatively low strength (especially in the elements which are fragile and fragile over time) become brittle). With regard to the practical use of the existing patents, it is possible to criticize: insufficient dosing accuracy, problems with uncontrolled discharge of the substance and inadequate ease of use for the user. Not all solutions meet the correct manufacturing conditions and some do not guarantee the safety of the patient during use. In the case of mechanisms based on a number of cam and wedge couplings, with respect to small sized devices, e.g. B. Injection devices, it has been found that cam-wedge designs of small size are not reliable - they tend to break during manufacture or during use.

In the known devices, the forces required to adjust and correct the dose are not homogeneous; in particular, the force required to reduce (correct) the dose is greater than the force for initially adjusting the dose. In addition, the required force can increase sharply when increasing the set dose. Some solutions require a locking device. Other solutions have no drive spring and are not automatic.

Therefore, there is a need to provide a mechanism that solves at least part of the above-mentioned problems and achieves, at least in part, the following effects: fewer elements, greater simplicity of construction, lower manufacturing costs, desirable strength during manufacture and use, reliability, durability , Dosing accuracy (in particular according to ISO 11608-1: 2014 ), low drip loss, ease of use for the user, easy operation, low dose setting or dose correction; Ensuring an identical force in dose setting and correction; a mechanism without a lock or piston which provides a means for effecting movement of a piston rod, ensures automatic dose delivery and requires little force from a user.

There is also a need to provide an improved method of delivering substances, particularly pharmacological substances.

SUMMARY

It concerns an adjustment mechanism for a metering device, in particular for a device for metering pharmaceutical or therapeutic substances, for example for a reusable injector, in particular for growth hormones. The adjustment mechanism may include at least four interconnected rotatable members, wherein at least two rotatable members may be rotatable during adjustment or correction of a dosage for the metering device. A first rotatable element may be a receiving element and have shafts. A second rotatable element or a third rotatable element or a fourth element may comprise corrugations coupled to the corrugations of the first rotatable element. The corrugations may be shaped to allow rotation of the at least four rotatable elements during delivery of the dose by the metering device.

In other words, it involves an adjustment mechanism for a dosing device, in particular for dosing pharmaceutical or therapeutic fluids, for example for a reusable injector, in particular for growth hormones. The adjustment mechanism may connect a control assembly for connecting the adjustment mechanism to a dose setting member of the metering device. The adjustment mechanism may further comprise a drive assembly for connecting the adjustment mechanism to a drive member of the metering device. The adjustment mechanism may further include a Dosing arrangement for connecting the adjustment mechanism with a metering of the metering device comprise. The control assembly may be coupled to the metering assembly by a spring member that may deform from a coupled position to a decoupled position during rotation of the dose adjusting knob, wherein in the decoupled position, the spring member may be configured to move therethrough A control arrangement relative to the metering assembly, and wherein in the coupled position, the spring member may be configured to block rotation of the control assembly for a metering assembly.

The rotatable elements may comprise: a control arrangement for connecting the adjustment mechanism to a dose setting element of the dosing device; a drive assembly for connecting the adjustment mechanism to a drive element of the metering device; and a metering arrangement for connecting the adjustment mechanism to a metering element of the metering device. The control assembly may be coupled to the metering assembly by a spring member that may deform from a coupled position to a decoupled position during rotation of the dose adjusting knob, wherein in the decoupled position, the spring member may be configured to move therethrough A control arrangement relative to the metering assembly, and wherein in the coupled position, the spring member may be configured to block rotation of the control assembly with respect to the metering assembly.

The mechanism may comprise at least two and preferably at least three rotatable elements which are rotatable with respect to the metering device, which are substantially fixed to each other.

The mechanism may comprise at least one rotatable element which is movable by axial or radial sliding.

The spring element can be separated from the drive element of the metering device.

The control arrangement and the metering arrangement may comprise corrugated elements which, in the coupled position, at least partially abut each other and which are spaced from each other in the decoupled position.

The corrugated elements may include axially projecting protrusions.

The corrugated elements can have friction surfaces or latching surfaces or toothed surfaces or connecting surfaces. The cooperating corrugated elements may be coaxial and have corrugations arranged in parallel planes. The mechanism may comprise at least two rows or rows of corrugated elements, preferably arranged in a circular array, on rotatable disc elements which preferably have a common center axis which abut one another or which are spaced apart from each other.

The waves of the at least two rows or rows of corrugated elements may have different heights or different angles of inclination.

The at least two or three rows of corrugated elements may be coupled with different thicknesses (in a particular case, the coupling strength of the corrugated elements may be the same).

The corrugated members may abut each other during rotation of the drive member in a dose setting direction and be separated from each other during rotation of the drive member in a dose correction direction.

The number of waves in the corrugated members of the control assembly may differ from the number of corrugations in the corrugated members of the metering assembly.

The mechanism may comprise at least one corrugated element which is indirectly or directly connected to the control arrangement, preferably by a coupling sleeve or by a coupling.

The spring element can be axially deformable. The control may be a disk.

The driving element may be a toothed disc arranged around the major axis.

Further, the mechanism may consist of a first clutch disc coaxial with the main axis of the mechanism and connected to the dose setting button.

The mechanism may also include a second clutch disc which may be coaxially connected to the main axis of the mechanism and may have teeth. This can be oriented opposite to the direction of the toothing of the first clutch disc. And it can be connected to the drive spring for expelling the dose. The mechanism may comprise a third clutch disc, which may be coaxially connected to the main axis of the mechanism and may have teeth aligned in the same direction as the teeth of the first clutch disc and axially movable along the main axis X of the clutch.

The mechanism may include a locking member that may have projections for coupling sliding with the inlets in the coupling, such that the coupling may be rotationally fixed relative to the locking member, but may move axially relative to the locking member and may engage with a latch on the latch be attached to the clutch disc of the spring.

The mechanism may include a nut that may be adapted to rotate the dose setting piston rod and may be dynamically connected to the locking element.

The mechanism may include a spring that may be mounted between the third clutch plate and the locking element and generates energy that urges the third clutch plate toward the second clutch plate.

The first clutch disc may be connected to the dose setting button by means of a rod. Opposite this rod, the first clutch disc is axially movable to the main axis of the mechanism.

Also, the mechanism may include a first clutch disc coaxial with the major axis which may be controlled by the dose setting knob and connected to the dose output driving spring.

The mechanism may comprise a second clutch disc which is coaxial with the major axis and may have teeth directed in the opposite direction to the direction of the teeth of the first clutch disc. The mechanism may comprise a third clutch disc which may be coaxial with the main axis of the mechanism, may have teeth directed in the same direction as the first clutch disc, and may be axially movable along the major axis of the mechanism.

The mechanism may comprise a third clutch disc which may be coaxial with the main axis of the mechanism and may have teeth directed in the same direction as the teeth of the first clutch disc and axially along the

The mechanism may include a latch assembly that may have projections for slidingly coupling with inlets in the first disk such that the disk may be immovable with respect to the latch member, but may be axially movable with respect to the latch member.

The mechanism may include a nut that may be adapted to rotate the dose-adjusting piston rod and may be connected to a fourth clutch plate. This is coaxial with the main axis of the mechanism and can be rotatably connected to the control or with other clutch discs.

The mechanism may include a spring that may be mounted between the first clutch plate and the control and that generates energy that urges the first clutch plate toward the second clutch plate.

Furthermore, the mechanism may have a housing which may be coaxial with the main axis of the mechanism and may be connected to a nut for dose adjustment.

The mechanism may comprise a first clutch disc coaxial with the main axis of the mechanism. On the opposite side of the teeth acts a barrier in the form of protrusions, which stands at a certain angle to the locking of the housing and whose position between the first clutch disc and the housing is to be arranged .. The mechanism can a Verdrill element between the first clutch disc and have the housing. The mechanism may comprise a second clutch disc which may be coaxial with the main axis of the mechanism and may be coupled to the first clutch disc and may have teeth directed in the opposite direction of the teeth of the first clutch disc.

The mechanism may include a nut that may be adapted to rotate the dose adjusting piston rod and may be neither rotatable nor movable connected to the second clutch disc.

Further, the mechanism may comprise a first clutch disc which may be coaxial with the main axis of the mechanism and which may be connected to the dose setting knob and may have raceways in which rolling elements are disposed.

The mechanism may comprise a second clutch disc which may be coaxially connected to the main axis X of the mechanism, which may comprise a spring element for urging the rolling elements against the rail. The track can be coaxial with that

Main axis of the mechanism and may have recesses with a radius corresponding to the radius of the rolling elements. The mechanism may include a nut that may be adapted to rotate the dose.

The mechanism may include a nut that may be adapted to rotate the dose setting piston rod and may be non-rotatably and non-movably connected to the second clutch disc.

Further, the mechanism may comprise a first clutch disc which may be coaxial with the main axis of the mechanism and which may be connected to the dose setting button and may have the raceways, in which rolling elements are arranged.

The mechanism may comprise a second clutch disc which may be coaxial with the main axis X of the mechanism, which may comprise a spring element for urging the rolling elements against the rail. The track can be coaxial with that

Main axis of the mechanism and may have recesses with a radius corresponding to the radius of the rolling elements. The mechanism may include a nut that may be adapted to rotate the dose setting piston rod and may be connected to the track.

The mechanism may comprise a first clutch disc which may be coaxial with the main axis of the mechanism and may be connected to the dose setting member.

The mechanism may comprise a second clutch disc, which may be coaxial with the main axis of the mechanism and may be formed on the inside of the cylindrical sleeve, which may have an inlet and an outlet delimited by a locking element and which overlaps with the first clutch disc Teeth of the second clutch disc may be coupled, which are directed in the direction opposite to the direction of the teeth of the first clutch disc.

The metering device exists according to the rotation of the dose setting element of the metering device in dose setting direction and / or in dose correction direction. The dose setting element may preferably be directly connected substantially to the same coupling element that couples the adjustment mechanism. The dosing arrangement may comprise a nut connected to the dosing element, preferably a piston, of the dosing device, the nut being connected to at least one rotatable element of the control arrangement and / or of the dosing arrangement. The control arrangement and the dosing arrangement can have at least one common element. The spring element may be a torsion spring, a compression spring or a torsional compression spring. The spring element can be radially deformable. The spring element can be axially deformable. The spring element may be an elastic fragment of the rotatable element which may be rotatable relative to the metering device. The rotatable elements may be configured to define a force acting in a directional motion according to a dose setting substantially equal to a force that provides for movement in a direction opposite to the dose setting direction. At least two rotatable elements and preferably three rotatable elements of the adjustment mechanism may be substantially immovable to each other, the mechanism may comprise a nut for driving the piston rod of the metering device, the nut being connected to a first or a second drive element. The control member may be a first clutch disc having shafts coaxial with the main axis of the mechanism, preferably with teeth disposed on a surface perpendicular to the main axis of the mechanism. The drive member may be a second clutch disc having shafts coaxial with the major axis of the mechanism, preferably with teeth opposite the teeth of the first disc. The first clutch plate may be axially movable with respect to the second disc along the major axis of the mechanism during rotation of the control member such that its mutual axial position changes from the coupled position to the decoupled position. The spring element can be axially deformable. The control may be a disc with protrusions. The drive element may be a disc with teeth arranged around the main axis.

Further, the mechanism may include a first clutch disc which may be coaxial with the main axis of the mechanism and may be connected to the dose setting button.

The mechanism may comprise a second clutch disc which may be coaxial with the main axis of the mechanism and may have teeth directed in a direction opposite to the direction of the teeth of the first clutch disc and may be connected to the drive spring for expelling the dose.

The mechanism may comprise a third clutch disc which may be coaxial with the main axis of the mechanism and may have teeth directed in the same direction as the teeth of the first clutch disc and axially movable along the main axis X of the clutch mechanism.

The mechanism may include a locking member which may have projections for coupling sliding with the inlets in the coupling, such that the coupling may be non-rotatable with respect to the locking member, but may move axially with respect to the locking member, and may engage with a latch on the pawl be attached to the clutch disc of the spring.

The mechanism may include a nut that may be adapted to the Dosstellstellkolbenstange to rotate, and may be rotatably connected to the locking element.

The mechanism may include a spring that can be mounted between the third clutch plate and the locking element and generates a force that presses the third clutch disc in the direction of the second clutch disc.

The first clutch disc may be connected to the dose setting knob by means of a rod against which the first clutch disc is axially movable with respect to the main axis of the mechanism.

Further, the mechanism may comprise a first clutch disc which may be coaxial with the major axis of the mechanism, which may be controlled by the dose setting knob and connected to the dose ejection drive spring.

The mechanism may comprise a second clutch disc which may be coaxial with the main axis of the mechanism and which may have teeth directed in the opposite direction of the teeth of the first clutch disc.

The mechanism may comprise a third clutch disc, which may be coaxial with respect to the main axis of the mechanism, may have teeth directed in the same direction as the first clutch disc, and may be axially movable along the major axis of the mechanism.

The mechanism may have a latching arrangement that may include projections for sliding engagement with inlets in the first disk such that the disk may be rotatably immovable with respect to the latching element but may move axially relative to the latching element.

The mechanism may include a nut that may be adapted to rotate the dose-adjusting piston rod, and may be connected to a fourth clutch disc, which may be coaxial with the main axis of the mechanism and rotatably connected to the control member, and other clutch discs.

The mechanism may include a spring that may be mounted between the first clutch plate and the control element and generates energy that urges the first clutch plate toward the second clutch plate.

Further, the mechanism may include a housing which may be coaxial with the main axis of the mechanism and may be connected to a nut for dose adjustment.

The mechanism may comprise a first clutch disc which may be coaxial with the main axis of the mechanism and may have on the side opposite its teeth a block in the form of a projection which abuts at a certain angle on a lock of the housing positioned between the first clutch disc and the housing.

The mechanism may include a twisting element between the first clutch plate and the housing.

The mechanism may comprise a second clutch disc which may be coaxial with the main axis of the mechanism and may be coupled to the first clutch disc and may have a toothing which is opposite to the direction of the teeth of the first clutch disc.

The mechanism may include a nut that may be adapted to rotate the dose adjusting piston rod and may be neither rotatable nor movable relative to the second clutch disc.

Further, the mechanism may comprise a first clutch disc which may be coaxial with the main axis of the mechanism and which may be connected to the dose setting knob and may have raceways in which rolling elements are disposed.

The mechanism may comprise a second clutch disc coaxially connected to the main axis X of the mechanism, which may comprise a spring element for urging the rolling elements against the rail. The track may be coaxial with the major axis and may have cuts of a radius corresponding to the rolling elements.

The mechanism may include a nut that may be adapted to rotate the dose adjusting piston rod and may be connected.

The mechanism may comprise a first clutch disc which may be coaxial with the major axis of the mechanism and connected to the dose.

The mechanism may comprise a second clutch disc, which may be coaxial with the main axis of the mechanism and on the Inside the cylindrical sleeve may be formed, which may have an inlet and an outlet which are delimited by a locking element and which can be coupled to the first clutch disc via the teeth of the second clutch disc. The toothing may be opposite to the direction of the teeth of the first clutch disc.

The toothing may protrude from the disc in a radial direction, with clamping elements for holding the first clutch disc in a middle position, coupled with the second clutch disc, between the first clutch disc and the locking elements.

The mechanism may include a nut that may be adapted to rotate the dose-adjusting piston rod and that may be connected to the second clutch disc. Also active is a metering device comprising the adjustment mechanism as described above and in the examples presented. The drive element of the device may be a torsion spring. The drive element may also be connected to the control arrangement.

The drive element may also be connected to the metering arrangement. The device may comprise at least two spring elements, the first spring element being a drive element for dispensing a liquid from a liquid container, and the second spring element being an element of the adjustment mechanism configured to act on the adjustment mechanism during dose setting and / or the dose correction. The release of energy accumulated in the first spring member may cause the second spring member to be rotated. a rotation corresponding to the metering assembly of the adjustment mechanism.

The proposed mechanism can be used in a method of injecting a pharmaceutical substance. The steps of: providing a dosing device comprising a reservoir having a plurality of doses of the substance; Adjusting a dose of the substance by rotating a dose setting element in a first direction, wherein during the dose setting the energy is stored in the device; Reducing the adjusted dose by rotating the dose setting member in a second direction, wherein during the reduction of the dose, the energy stored in the device is released.

The storage of energy in the device may be effected by the adjustment mechanism by placing the control assembly connected to the dose setting element and coupled to the drive assembly for releasing the energy stored in the device into the decoupled position. In this position, movement of the control assembly is observed with respect to the dosing assembly, which is either released or in a coupled position in which rotation of the control assembly with respect to the dosing assembly is blocked.

The storage of energy in the device may be effected by the adjustment mechanism in which at least two elements are rotatable during dose adjustment or descent and at least four elements are rotated during delivery of the dose during release of energy stored in the device.

The adjustment mechanism can be used in metering devices of various types. In pharmaceutical or therapeutic substance applicators reservoirs are used which comprise a certain substance, which are typically pre-filled, for example with a volume of 1.5 or 2.4 or 3.0 ml. The substance may be a liquid or a suspension, a drug , a vaccine or other ingredients. An example of substances commonly delivered in this manner are insulin and its analogs. Growth hormone, teriparatide, GLP 1 or other substances are also used. Overall, this may include drugs containing peptides, proteins, small molecules, biologically derived ingredients, active biologics.

Ingredients, hormonal ingredients, genetic ingredients or the like. The device can be used with any of these substances or with other substances. The adjustment mechanism may be used in metering devices (also known as injectors) of the "reusable" or "permanent" type as well as the "pre-filled" or "disposable" type.

Reusable devices allow a user to replace one used reservoir with another. On the other hand, disposable devices are equipped with a built-in reservoir that is not expected to be replaced. The substance is injected through a needle attached to the device by the flow through a perforated partition wall of the reservoir.

The adjustment mechanism can be used in manual or automatic dosing devices. In particular, in automatic devices, a drive spring is used for injecting the pharmacological substance. In a preferred embodiment, the solution offers the possibility of use in one automatic dosing device (an automatic injector), ie in a dosing device using spring means, preferably a torsion spring, for expelling the medicament, preferably by transferring the force to an axially movable piston, which is preferably connected to a knob. In the injector shown here, the spring acting as a drive spring may be a preloaded spring.

It is possible to use a relaxed spring. As spring means (in particular drive spring means) can be used any kind of means for collecting energy by deformation, in particular coil springs, coil springs, clock springs, compression springs, torsion springs or elastomer springs. The adjustment mechanism can be used in metering devices that allow delivery of variable doses, as well as in dosing devices that deliver a fixed dose. The adjustment mechanism may be used in metering devices that include a maximum dose limiter, plug, or other system that permits control of the last dose or prevents delivery of a larger dose than the dose remaining in the reservoir, such as, for example, about EP1458440B1 known injectors or out EP2274032B1 ,

The adjustment mechanism can be used in dosing devices that allow a reduction in the set dose. The reduction can be carried out by dose-resetting, such as in WO2013119132 described. The reduction can also be performed in other ways, using arrangements such as those described in U.S. Pat EP1954337 or WO2006126902 or other documents cited therein.

In particular, reducing the dose may allow for a reduction by any number of adjusted units. One or more operations will result in reaching the home position (normally referred to as 0).

The adjustment mechanism can be used in dosing devices that allow one dose to be selected in one direction only. For example, the movement of one of the discs in a direction opposite to the dose setting direction may be inhibited, the movement being inhibited opposite to the setting on the dose setting member. Or one or more elements responsible for the movement opposite to the dose setting direction allow unilateral movement of the adjustment mechanism.

The adjustment mechanism can be used in a device in which the release button is pressed until the end of the injection, wherein the stopping of the pressing leads to an automatic return of the release button to the initial position.

The adjustment mechanism may be used in metering devices, particularly for multiple injections of individually adjusted cans from a reservoir. This comprises: a housing, a drive element configured to eject a dose of fluid from a reservoir, spring means. The adjustment mechanism may be mounted in the housing and may be connected to spring means.

The device may include a dose setting member movable in a first direction to a selected position set with respect to the spring means. In this case, the movement of the dose setting element can be accompanied by the compression of a spring. In this case, the dose setting element can be movable in a second direction to selectively regulate the set dose. A latch assembly that holds the injection device in a fixed position with respect to the compression of the spring may be connected to the housing. In this case, the lock can be designed so that it triggers a control element for ejecting the set dose from the reservoir. The force to expel the adjusted dose may be provided by spring means.

The adjustment mechanism may be used in metering devices having a housing, a dose setting mechanism for adjusting the dose to be administered from the substance reservoir when the substance reservoir can be coupled to the housing, and further comprising a dose delivery mechanism.

The mechanism may include a dose-setting structure for adjusting the initial dose and a dose-indicating structure, wherein the dose-setting structure and the dose-indicating structure may be coupled to have correlated shifts with respect to the housing during the initial dose setting and during the dose delivery, wherein the correlated shifts during the dose setting are opposite in relation to the correlated shifts during the dose delivery, wherein the dose setting structure may be shifted to a prepared dose position to adjust the initial dose. The dose position is prepared and can be fixed with respect to the housing. The dose indicating structure during the dose delivery may be shifted to a dose stop position, wherein the dose stop position may be fixed with respect to the housing, and wherein the Dose display structure is selectively displaceable with respect to the housing when the dose setting structure can be located in the housing to allow adjustment of the initial dose and setting the final dose.

The mechanism may be used in a method of assisting a patient in injecting a pharmaceutical substance, which may include the following steps: instructions to the patient about the use of a dosing device comprising a reservoir with a plurality of substance doses and a drive element, and the Energy used. The patient gathers this knowledge to get the substance out of the dosing device; Information and instructions for adjusting the dose of substance by rotating the dose setting member in a first direction to the patient; Providing information and instructions to the patient that the dose may be reduced by rotating the dose-setting element in a second direction; Information and instructions to the patient to press an actuator of the device which releases the energy stored in the device during the dose setting and causes the expulsion of at least a portion of the substance from the reservoir (the actuator may automatically return to the previous state) releasing the contact).

The mechanism may also be used in a method of treating a disease that requires the injection of the medical substance without the help of others. This may include feeding a dosing device comprising a reservoir having a plurality of substance doses. The mechanism may also be used in a method in which an injection device may be provided, wherein the dose may be selected.

The dose setting direction generates accumulation energy for moving a piston rod, finally ejecting the set dose from the device, and there is an optional dose reduction by moving a dose setting element in a second direction (this direction can correct the dose ). The delivery of the energy stored in the device can in particular be effected by using a (preferably axial) device (activated or held) until the dose is expelled. The discharge after exceeding a limit value for activating the applied force substantially results in a constant velocity of the outflow of the substance, regardless of the extent of exceeding the limit value (without taking into account the initial movement differentiation and the speed increase until reaching the desired speed).

The mechanism is particularly useful in devices that essentially require a constant injection time for a particular dose. Preferably, the time for 20 IU injection is in the range of 0.9 to 1.8 seconds, and for 40 IU, the time is in the range of 2.1 to 3.6 seconds. Preferably, the injection force does not exceed 10 N and is preferably close to 5 N. Preferably, the injection force does not substantially change in accordance with the size of the selected (adjusted) dose.

BRIEF DESCRIPTION OF THE GRAPHIC ARTICLES

The attached drawing contains the following figures: - show examples of applicators in which the adjustment mechanisms of exemplary embodiments may be used; - show a construction of a mechanism and the - show their way of working; - show a construction of a mechanism according to another embodiment; . show another embodiment of a mechanism, and the . show an example of an applicator, this mechanism can be used, and - show their operating method in a partial cross-sectional view; - show another embodiment of a mechanism - show a construction of an example of an applicator, which mechanism can be used, and FIGS - show his way of working;

shows another embodiment of a mechanism, and 10A-1 OH show its operation; - show another embodiment of a mechanism, and the - show its functioning.

DETAILED DESCRIPTION

. show an example of the application of a mechanism in an automatic applicator for liquid pharmaceutical preparations, for example for growth hormones, for the repeated delivery of dosages of the liquid preparation from an exchangeable container by injection. shows a longitudinal sectional view of the applicator, and shows an exploded view. This type of applicator is in a patent document PL215310 described in detail his operating principles.

The applicator may comprise a two-part body, 11, which is provided with a housing, 12, a container is associated with a liquid pharmaceutical preparation (whether interchangeable or not does not matter here). The liquid preparation may be expelled from the container by a piston rod 4, which terminates in a piston connected to an adjustment device.

The mechanism is linearly movable by an adjustment mechanism, and may be of a type as described in detail with respect to the embodiments shown below. An adjustment mechanism, 200, like the one in and can be seen is in to see.

4C-4D, can be used in this applicator. The mechanism may be driven by a drive spring 3, in this example a coil spring.

The drive spring, 3, can be in the body 11 can be arranged and can by a dose adjustment button 1 be tense. The adjustment mechanism can by an actuator 14 to be activated. A printed scale (not shown in this illustration) may be graduated on a sleeve 16 put on and through an inspection opening 13 become visible.

The automatic applicator can work as follows. In the case of a reusable injector, to replace the liquid preparation container, the housing should 12 of the container, with the body 11 is connected, be unscrewed. After unscrewing the container 12 becomes the locking of the piston rod 4 decoupled from the enveloping element, which is effected by the pressure of the spring, by the locking of the piston rod in the axial direction is moved towards the piston. In both of the decoupled subject elements special cutouts are to install and to solve. This allows manual retraction of the piston rod 4 by the action of a force in the axial direction, whereby it is pressed into the body. The tip can be mounted on the piston rod so that it can rotate independently.

Because the connection between the piston rod 4 and a mother 61 can be done using a non-self-locking thread, while the piston rod is inserted into this thread, it is automatically in the driving nut 61 screwed. The force should be exerted on the piston rod 4 until the piston rod is completely in the body 11 hides and allows to install a new container with a liquid preparation.

If the applicator is of the disposable type, it can encompass a non-replaceable container and the housing 12 can not from the body 11 be unscrewed, and the above-mentioned aspects can be ignored.

The drive nut 61 and the piston rod 4 may be connected to each other by a thread having a pitch which allows the delivery of a correct dose of the liquid preparation. In addition, the drive nut can 61 be stored in the Hüllelement, preferably in a ball bearing.

Next, a needle (not shown) should be placed in the housing 12 the container is unscrewed (preferably by turning counterclockwise), after which the empty container for the growth hormone should be removed by removing it from the housing 12 is pushed out. And a new container should be installed in this location.

To install a new container, it should be placed in the container housing 12 be pushed, then by turning clockwise in the body 11 should be used. Next, a new needle should be mounted and the housing 12 should be pushed over, which may be a lock nut.

The dose setting can be adjusted by turning the knob 1 in a dose setting direction, for example clockwise. The currently set dose may be on a part of the cylindrical sleeve 16 through a window of the inspection opening 13 in the body 11 be visible, which together with the scale, in particular linearly below the locking projection, on a cylindrical sleeve 16 is applied.

The button 1 can be rigid with a coupling sleeve 2 be connected, and if the dose is to be increased, the coupling sleeve 2 be rotated in the dose setting direction, which has a tensioning of the drive spring by the adjustment mechanism according to their operating principle to action. The adjustment mechanism may preferably be rigid with a spring 3 connected with a castle 15 the spring can be connected.

The barrier 15 the feather 3 can be rigid with the body protected from rotation 11 be connected.

During the dose setting, the drive nut can 61 by an actuator 14 by means of rectangular grooves 62 located on the circumference of the drive nut 61 be held. A lead 63 of the actuating element 14 interacts with these grooves.

The working range of the applicator can be determined by the locking projection, directly on the peripheral surface of the sleeve 16 is arranged. It works with the projection on the inner part of the cylindrical surface of the body 11 which is located above or below the control window 13.

These projections may be on the opposite sides and at the same time slightly displaced axially. Such a location makes it possible to perform an incomplete rotation of the sleeve, which may comprise the projection.

After adjusting the dose, the dosage of the liquid preparation by moving the actuator 14 done in the direction of the needle.

During the entire time the substance is dispensed, the button can be held in a depressed position. The range of the actuator 14 can through the lead 63 in a groove 64 of the body 11 be determined.

After pushing the actuator 14 becomes the driving nut 61 by decoupling the arranged on the sprocket disc driver 61 Approved.

The mechanism starts due to a force of the spring 3 to turn. The rotation of the drive nut 61 causes a unscrewing of the piston rod 4 through a threaded connection. The piston rod 4 before rotation can be blocked by an inlet on the piston rod lock and a recess in the piston rod.

The piston rod 4 acts directly on the piston of the container with the liquid substance contained in the housing 12 the container is and causes an injection of the substance through the needle, which on the housing 12 the container is attached. At the same time the movement can be accompanied by retracting the entire adjustment mechanism to the starting position, ie the drive spring can be returned to the initial bias, and the sleeve 16 with the scale returns to the starting position (typically referred to as "0"). After completion of the dosage, the actuator can 14 be solved, due to the spring, which is located directly under the assembly of the actuator 14 can be located, automatically returns to its original position and the drive nut 61 blocked again.

APPLICATION EXAMPLE

. show an example of the application of the mechanism with another automatic applicator for liquid pharmaceutical preparations, for example for growth hormones, for the repeated injection of adjusted doses from a swap body. shows an applicator in a longitudinal sectional view and in an exploded view. An applicator of this kind is in the patent PL214940 and has a similar operating principle.

The applicator may comprise an array of at least two movably interconnected sleeves: a display sleeve 31 (which may be divided into an inner and an outer part or which may be integrated) and a drive sleeve 21 may include indicia on its outer surface (not shown in the drawings). The sleeve may be longitudinal with a pull-pressure control nut 41 be connected. The whole mechanism can be in one case 51 be arranged.

The indicator sleeve 31 can be slidable, longitudinal and coaxial on the drive sleeve 21 be mounted by means of a wedge-toothing, a coupling in the form of multiple projections. The latter include the keyways 23 the drive sleeve 21 and (not shown in the drawing) protrusions of the display sleeve 31 wherein the projections may be in the form of bayonet projections. The display sleeve 31 may be movably mounted between two end positions that define the working area of the indicator sleeve 31 determine. The drive sleeve 21 can be rotatably mounted.

The train-pressure control nut 41 can rotate on the drive sleeve 21 be fastened by means of a threaded connection, which consists of a thread groove 22 consists. In addition, there is a drive sleeve 21 and a thread 43 arranged and the control nut 41 , preferably non-self-locking thread.

The pull-pushing control nut 41 can in the case 51 the applicator be axially fixed by means of a recess connection; preferably by means of a plurality of protrusions coming from the keyways 52 of the housing 51 and protrusions 42 consist of the drawbar. The indicator sleeve 31 can by means of a lock, preferably a circumferential lock, which consists of a lock 32 the indicator sleeve 31 and a lock 44 the helm mother 41 consists longitudinally connected to the pulling-pushing control nut. The indicator sleeve 31 can be attached to the drive sleeve 21 with its outer surface at a fixed distance from the inner surface of the housing 51 be attached to the applicator. casing 51 can be a window of an inspection opening 53 include. And the outer surface of the display sleeve 31 may preferably exist in the form of display symbols which are spirally mounted.

The drive sleeve 21 may be connected to the drive element in the form of springs, preferably in the form of a cylindrical coil spring 3 , The attachment of the spring may be via arcuate portions of distal and proximal portions of the spring (eg, U-shaped, C-shaped) attached to openings in contact elements (not shown).

The spring may also be mounted on a projection or notch which is inserted or permanently fused to the mass with the resisting element.

The drive sleeve 21 may be connected to the drug dosing mechanism in the form of an assembly. This arrangement combines a dose setting element (button) 1 , a connecting element 2 of the button 1 with an adjustment mechanism, a spring element 3 , a lock of the spring element 56 , a piston rod 4 , an adjustment mechanism, release means (an actuator) 54, and a housing of a container 12 ,

The dose setting element essentially undergoes a rotatable movement. The release elements (or means) may be connected to the spring (drive) element (or means), also in the form of a trigger, an actuation button or other shapes (such as from the documents WO2009105909 . EP2451508 . WO2015071289 known).

The release device moves substantially in the axis of the injector. The release device may comprise an additional spring element which allows a return to the starting position.

The adjustment mechanism may operate in one of the embodiments illustrated herein.

In this example, there is the applicator with the adjustment mechanism 200 which is equivalent to that in the and shown mechanism 4C - 4D is (also corresponds to that shown in the 2C-2D).

The indicator assembly works as follows: When the dose is to be adjusted, the drive sleeve should 21 clockwise (increasing setting) or counterclockwise (correcting setting). The pulling-pushing control nut 41 moves along the drive sleeve and through a threaded coupling by means of the inner sleeve. The thread 43 slides in a thread groove 22 attached to the outer surface of the cylindrical drive sleeve 21 is cut. The rotation is done using the button 1 where the button 1 after completion of the injection during the opposite movement can take any angular position with respect to the housing. The movement can be blocked at the button, the housing.

Or on other elements of the mechanism, including adding more elements or elements. The control mother 41 can against the rotation by means of the projections 42 secured axially with respect to the keyways 52 Slip on the inner wall of the cylindrical housing 51 be generated.

Such a connection allows a greater clearance between the outer cylinder of the pulling-pushing control nut 41 and to maintain the inner cylinder Wali. As well as between the inner cylindrical walls of the housing 51 , as well as between the outer cylindrical part of the display sleeve 31 and the inner cylindrical wali of the housing 51 , It contributes to the elimination of friction between the cylindrical parts, which is much lower in the case of axial friction of the projections 42 in the keyways 52 that hold the display mechanism in the central pivot point.

The pull-pushing control nut 41 slides along the housing 51 and pulls during dose adjustment or reduction.

Or, conversely, during the dose correction, pushes the indicator sleeve 31 by means of the projections 42 with the latch 32 the indicator sleeve.

The indicator sleeve 31 Moves out of a compound movement because it passes through the control nut 41 can be pulled or pushed axially. And because they are at the same time with the drive sleeve 21 rotates because they are using the spline coupling 23 on the outside of Wali allows such a connection, an increased clearance between the outer cylinder of the drive sleeve 21 and the inner cylindrical wali of the indicator sleeve 31 , which contributes to the elimination of the friction between cylindrical parts, which is much lower in the case of axial friction in the splined shaft coupling 23 that holds the mechanism in the central pivot point.

The composite movement of the indicator sleeve is a spiral movement with respect to the window of the viewing aperture 53 in the case 51 What makes it possible for the display sleeve 31 in relation to the housing 51 in an axial range to move an arbitrary number of revolutions. To move the display sleeve 31 in relation to the drive sleeve 21 It should be noted that the direction of rotation can be changed so that the increasing adjustment during the rotation of the drive sleeve 21 can be achieved counterclockwise.

In such a configuration, the decreasing setting may occur during rotation of the drive sleeve 21 be achieved in a clockwise direction. The structure of the illustrated display mechanism is based on the principle of cooperating cylinders connected by the spline coupling so that there is substantially no friction between surfaces of cylindrical elements.

And thus, the forces coming from other spring (drive) elements can be smaller, which causes more uniform operation of the applicator during dose setting and delivery of the drug. The axial configuration of the can interact.

In the elements provided by multiple protrusions, the precision of drug delivery affects by eliminating the forces acting on the dosing elements during dose setting, which affects the flow of the liquid preparation and reduces the actual dose of liquid preparation in the dose setting phase.

A coupling of the display elements of the automatic applicator takes place. The indicator sleeve 31 acts with the drive sleeve 21 together. The train-pressure control nut 41 interacts with these elements. This allows for a precise, controlled reduction of an incorrectly adjusted excessive drug dose while maintaining the automatic delivery of the drug, thereby ensuring use in an automatic liquid preparation applicator, particularly growth hormone, for multiple injection delivery of ready-to-use dosages from a container.

AUDFÜHRUNGSFORM

. show one of the embodiments of the mechanism in an exploded view, and the - show the way of working.

The mechanism may comprise a first coupling element. In this example, it may be a first movable member, preferably rotatable, preferably a clutch disc 111 which may be coaxial with a major axis X of the mechanism. The first clutch disc 111 may be connected to a dose setting element, for example in the form of a button (not shown in this drawing). The dose setting element can be connected via a connecting element 102 be connected to the mechanism to transfer the power from the user to the mechanism.

The connecting element 102 For example, it may be a rod, sleeve, cylinder or other suitably shaped element. This connection is provided by the end portion of the connecting element, in this example by a first end portion 1021 the pole 102 ,

At a second end portion 1022 the pole 102 the first coupling element can be positioned, in this example the first coupling plate 111 , The Elements 102 and 111 can be removable or integrated. The pole 102 and the first clutch disc 111 therefore form the elements of the control arrangement 110 ,

The control arrangement 110 may be associated with the dose setting element with which the user can adjust or correct the dose to be applied. The elements may be connected by inlets, protrusions or other means ensuring secure attachment.

The mechanism may further comprise a second coupling element. It can be a second clutch disc 121 be positioned coaxially to the main axis X of the mechanism. The second clutch disc 121 can be coupled to the first clutch disc.

In this example, corrugated elements for interaction between the discs 121 and 111 care, preferably in a form of teeth 122 the second clutch disc 121 in the opposite direction to the teeth 112 the first clutch disc 111 point.

The second clutch disc 121 may be an element of the drive assembly 120 be connected to the drive spring (not shown in this drawing) for delivering the dose. The drive spring may directly or through additional connecting elements with the drive assembly 120 be connected.

The mechanism may also include a third coupling element. It can be a third clutch disc 131 may be coaxial with the main axis X of the mechanism.

The third clutch disc 131 can with the second clutch disc 121 be coupled. In this example, corrugated elements for interaction between the discs 131 and 121 care, preferably the teeth 132 , the third clutch disc 131 in the opposite direction to the teeth 122 the second clutch disc 121 point.

In other words, the third clutch disc 131 and the teeth 132 pointing in the same direction as the teeth 112 the first clutch disc 111 , The third clutch disc 131 can slide axially along the major axis X of the mechanism.

A locking element 171 can with the drive assembly 120 be connected. This connection can be made by a lock 172 be guaranteed, with a lock 123 or other connections. The locking element 171 fixes the third clutch disc 131 opposite the locking element 171 that does not turn. In addition, the locking element allows 171 an axial movement of the third clutch disc 131 opposite the locking element 171 ,

For example, for this purpose, projections 173 be provided, which sliding with inlets 133 in the third clutch disc 131 are coupled.

On the locking element 171 can directly or through additional elements a mother 161 connected, which is suitable for rotating the piston rod for dosing the set dose (not shown in this drawing). The mother 161 may therefore be an element of the dosing 160 of the mechanism.

Between the third clutch disc 131 and the locking element 171 may be a pressure element for pressing the third clutch disc 131 on the second clutch disc 121 be mounted. In this example, the pressure element may be a compression spring 151 but the pressure element may also be a spring element of another type which forms a separate element or an integral part of at least one of the additional elements. For example, these may be resilient projections that in the third clutch disc 131 or the locking element 171 are formed.

In this embodiment, the control clutch 110 therefore by the spring element 151 with the dosing arrangement 160 coupled, which deforms during the rotation of the dose setting knob in a decoupled position. And the one movement of the control arrangement 110 in terms of metering and in a coupled position the rotation of the control assembly 110 blocked with respect to the dosing arrangement 160 ,

In other words, in this embodiment, the adjustment mechanism may comprise at least four rotatable elements which are interconnected ( 102 . 111 . 121 . 131 , 151, 160, 171), at least two of them ( 102 . 111 . 121 ) can be rotatable when setting or reducing the dose f.

The first rotatable element ( 111 ) may be a receiving element and may have waves, and the second rotatable element ( 121 ) may have shafts which cooperate with the shafts of the first rotatable element, which shafts may be shaped to allow rotation of at least four 102 . 111 . 121 . 131 . 151 . 160 . 171 ) may comprise rotatable elements during delivery of the dose by the metering device.

The mechanism according to this embodiment operates as follows: During adjustment of the mechanism, the housing can be locked motionless with respect to the applicator, for example, the button 161 be designed motionless with respect to the housing of the applicator (by means of the locking or release device, for example by means of an actuating element).

If you want to dose, the button should 161 are released and the entire mechanism simultaneously rotates by means of the drive spring to deliver the dose and its elements maintain the same position relative to each other. Therefore, the mechanism works when the dose is adjusted or reduced (corrected).

The starting position is in shown. During the dose adjustment, the in is shown, the user starts the first clutch disc 111 to turn using a button. This happens in the dose setting direction indicated with a horizontal arrow and causes rotation of the second clutch disc 121 because the clutch discs 111 and 121 be reconciled with each other. Because the third clutch disc 131 can not turn, it starts to slide on the sloping wall of the teeth and simultaneously moves down, taking the spring 151 stressed.

This element moves axially. This happens until the tips of the teeth of the second clutch disc 121 and the third clutch disc 131 move, and then press the spring 151 the disc 131 back to the starting position, but one tooth further. The rotating clutch disc 121 Clamps the drive spring and thereby accumulates a force to eject the dose.

During the dose correction, the in is shown, the user starts the first clutch disc 111 using the button in the dose correction direction opposite to turn. At the dose rate, see: www.tis-gdv.de/tis_e/ware/nuesse/hasel/hasel.htm Setting direction, which is indicated by the horizontal line, begin the teeth 112 the first clutch disc 111 in terms of the teeth 122 the second clutch disc 121 to slide, indicating a downward movement of the first clutch disc 111 causes. Also the third clutch disc 131 and compression of the spring 151 come on the move.

To the distance between the panes: the second distance 121 and the first 111 and the third 131 are increasing.

The disks 132 the third disc 131 are not higher than the teeth 112 the first disc 111 and therefore would not decouple the first disc 111 cause. When the tips of the teeth of the second disc 121 and the third disc 131 pass each other, then the second disc can 121 from the coupling with the disc 111 and the second disc 121 be solved, like out is apparent. The third disc 131 begins to rotate due to the action of the drive spring, releasing the energy accumulated in the drive spring.

At the same time the spring causes 151 an axial return movement of the first disc 111 and the third disc 131 towards the second disc 121 and the entire mechanism can be corrected by one dose. Therefore, the third clutch disc moves 131 during dose adjustment and correction not. The third clutch disc 131 However, it rotates during the delivery of the dose when together with the mother 161 is turned.

The rotation of the second disc 121 in terms of the third disc 131 defines a degree of spring tension and the dose to be used. and show an embodiment of the adjustment mechanism, the elements of which may behave analogously to Example of 2A-2B, while the elements not shown may have other shapes. and resemble a clutch. The spring element 151 can be based on other types of elements than those in the example of 1 and 2 are shown, for example, by the housing of the device, an element of another mechanism, etc ..

Embodiment

- show another embodiment of the adjustment mechanism.

The mechanism differs from the embodiment of the and , 2x and 3x show that rod 202 and the first clutch disc 211 can be axially mutually movable elements. In this example, the first clutch disc 211 the shape of a ring with inlets 2111 have, which are formed inside in its inner band, and the longitudinal projections 2021 interact at the end of the pole 202 are positioned.

When the first clutch disc 211 Consequently, during operation of the mechanism, the rod can move axially 202 maintain their axial position. This contributes to a simplification, in part the rod 202 comprehensive mechanism and in particular its connection with the dose setting.

The remaining elements of this embodiment, which are designated by the reference numeral XXX, elements of the in the and correspond to the embodiment shown. 2x and 3x and designated by the reference numeral 1xx.

and show an adjustment mechanism, the elements of which may be ana-log to 4A-4B, wherein the elements not shown may have other shapes. The in the and is a dog clutch. In this mechanism, the clutch moves axially. The spring element 251 may be supported by elements other than 4A-4B, such as the housing of the device, an element of another mechanism, etc.

The rotatable elements shown may be configured to define substantially equal force acting both in the dose setting direction and in the opposite direction. Deviations in this range may result from the technical specification of the manufactured device, e.g. Manufacturing tolerances of components. Nevertheless, the principle of operation of the device should ensure essentially the same (equal) force (taking into account possible manufacturing deviations).

In another embodiment, the mechanism may be used to separate set dose levels in the dosing device in conjunction with a dog clutch. The metering device may include a coupling element in the form of a nut or ring with the ability to move to the selected setting position that is operatively connected to the mechanism. The movement of the dose setting element in the first dose setting direction may be accompanied by a tensioning of the drive spring, which provides a force for discharging the set dose. The apparatus may include means for releasing the nut which causes the mechanism to return to its initial position for driving the rod by unidirectional coupling to expel the set dose. The Apparatus may include an assembly of a large pitch (fast pitch) screw which is capable of converting the rotational movement of the mechanism into a linear movement of the piston rod. The movement of the piston rod can be achieved by using the energy stored in the drive element, which can preferably be rotated when the initially set dose of substance for injection can be adjusted by movement of the dose setting element in the first direction.

Preferably, the dose setting member may be a knob that performs a rotational movement that is substantially arranged in the end portion of the injector. The piston rod may have a non-circular cross-section and an external thread. A drive of the piston rod may comprise two elements, namely a piston rod guide and a nut, which may have an internal thread suitable for the thread of the piston rod. A unidirectional coupling may be provided between the nut and the piston rod guide, which permits rotation of these parts in one direction but not in the opposite direction, the rotation which has been allowed being the only one by which the piston rod is allowed to pass a circumferential direction to be carried in the device.

The clutch may be designed so that the initial resistance, which is large enough to withstand the torque acting on the clutch due to the adjustment of the dose, must be overcome for rotation to occur. In the mother, instead of the thread, a guideway may be present. In this case, the piston rotates and moves axially (during the injection).

Embodiment

. show another embodiment of the mechanism in an exploded view. Figures 5C, 50 show an example of an applicator, which mechanism can be used, and - show their functionality in a view in a partial cross-section.

The mechanism may comprise a first coupling element. In this case, it may be a first clutch disc 311 act, which may be coaxial with the main axis X of the mechanism. The first clutch disc 311 can be rotated by a dose setting element, for example in the form of a button (not shown in this drawing). The element that is the first clutch disc 311 connects to the dose setting element, a connecting element 302 may be, for example, a rod, a sleeve, a cylinder or other suitably shaped element. This connection can be made possible by an end part of the connecting element, for example first end part 3021 the pole 302 , At the other end part 3022 the pole 302 can be a case 371 (which may also be referred to as a) may be arranged.

The housing 371 , the pole 302 and the first clutch disc 311 may be the elements of the control arrangement 310 be. It may be connected to the dose setting element, which allows the user to adjust or correct the dose to be applied. The housing 371 may also be connected to a drive spring (not shown in this drawing) for delivery of the dose. In this embodiment, the housing 371 also an element of the drive arrangement 320 be.

The drive spring can thus both with the control arrangement 310 as well as with the drive assembly 320 be connected. The drive spring can be directly or through additional connection to the housing 371 be connected. The first clutch disc 311 may be movable axially along the main axis X of the mechanism. In this embodiment, the first clutch disc 311 on its outer edge inlets 313 have, with the longitudinal projections 373 on the inner surface of the cylindrical housing 371 interact.

The mechanism may further comprise a second coupling element. In this example there may be a second clutch disc 321 may be coaxial with the main axis X of the mechanism. The second coupling disc 321 can with the first coupling disc 311 be coupled. In this example, the element may have an interaction between the first disc 311 and the second disc 321 allows, consist of the following: The teeth 322 the second coupling disc 321 in the opposite direction of the teeth 312 the first clutch disc 311 and can be reconciled with them. In this case, the second clutch disc 321 axially movable along the main axis X of the mechanism. The second clutch disc 321 can with the first clutch disc 311 be movable.

The mechanism may also include a third coupling element. This embodiment may be a third clutch disc 331 act, which can be positioned coaxially to a major axis X of the mechanism and can be mounted on the other side of the ring on which the second clutch disc 321 can be arranged. In other examples, the second disc may be 321 and the third disc 331 be arranged on different elements. The third clutch disc 331 may be movable axially along the main axis X of the mechanism.

The housing 371 forms together with a stop ring 381 the elements of the locking arrangement within which the clutch discs move. Here is the first clutch disc 311 is not movable, but the other discs may be axially movable and may be rotatable with respect to the latching arrangement. In the locking arrangement can also be a mother 361 be provided, which is provided for rotating the piston rod and dosage of the dose (not shown in the drawing).

The mother 361 thus forms an element of the dosing 360 of the mechanism. The mother 361 can with a fourth clutch disc 341 be connected, which may be arranged coaxially to the main axis X of the mechanism. The fourth clutch disc 341 can be supplemented by other clutch discs: the third disc 331 , the second disc 321 and the first disc 311 come into question; between the first clutch disc 311 and the housing 371 that is rotatable with the drive assembly 310 are connected. In addition, a pressure element for pressing the first clutch disc 311 in the direction of the second clutch disc 321 ,

In this embodiment, the pressure element may be a compression spring 351 but it may also be another type of spring element which is a separate element or integral component of at least one of the remaining elements. For example, there may be elastic projections in the first clutch plate 311 or the housing 371 the control arrangement are formed. Thus, the first clutch disc 311 with the control arrangement 310 be connected to an axial movement of the first disc 311 to allow with respect to the control arrangement 310 , The control arrangement 310 may be during dose setting, dose correction and during use of the drug.

The second disc 321 and the third disc 331 can perform both a rotary and an axial movement. The fourth clutch disc 341 can be rigid with the mother 361 be connected. Between the case 371 and the first toothed disc 311 can a compression spring 351 which can be compressed during dose adjustment and correction. The stop-ring 381 Can be fixed to the case 371 be connected, resulting in that spring forces can be accommodated in this arrangement and are not transmitted to other parts of the applicator. In other words, in this embodiment, the adjustment mechanism may comprise at least four rotatable elements ( 302 . 311 . 321 . 331 . 341 . 351 . 361 . 371 ), which are connected to each other, wherein the rotatable elements ( 302 . 311 . 321 . 331 . 351 . 371 ) may be rotatable during dose setting or dose reduction on the dosing device.

The first rotatable element ( 311 ) can be a receiving element and have waves, and the second rotatable element ( 321 ) may have corrugations cooperating with shafts of the first rotatable member, which shafts may be shaped to allow rotation thereof; a total of at least four rotatable elements are involved ( 302 . 311 . 321 . 331 . 341 . 351 . 361 . 371 ).

Delivery of the dose through the metering device. The mechanism according to this example operates as follows: The mechanism operates using four coupling elements having cooperating corrugated surfaces, preferably toothed disks. The initial state is shown in Fig. 6A.

Delivery of the dose through the metering device.

The mechanism according to this example operates as follows: The mechanism operates using four coupling elements. During the dose adjustment, the housing 371 be the drive element. When the user starts to turn it by means of a button (in the direction indicated by the arrow in 68 is displayed), it causes a simultaneous rotation of the first rotatable disc 311 because the elements 371 and 311 with the fasteners 313 and can be connected. As the first disc 311 not in relation to the case 371 she turns along with her, and her teeth 312 start on the sloping walls of the teeth 322 the second toothed disc 321 and at the same time slide the first disc. 311 moves up and tightens the spring 351 , The second toothed disc 321 can be immobile with the third toothed disc 331 be connected.

The third toothed disc 331 can with the fourth toothed disc 341 to be consistent. The fourth toothed disc 341 can with the toothed wheel 361 connected his mother. Consequently, the movement of the second toothed disc 321 be impossible. This stays that way until the tips of the teeth are up 312 and 322 pass and then the spring 351 the first disc 311 pushes back to the initial position, but a section further (as in will be shown).

To correct the dose, the case should be 371 be rotated in the direction opposite to the dose setting direction (ie in the direction indicated by the arrow in 60 shown direction). The first clutch disc 311 So it can be relative to the case 371 do not turn.

These two elements are starting to turn. During the dose correction, the teeth can 312 the first disc 311 thus immovable with the teeth 322 the second disc 321 be engaged. The teeth 332 the third disc 331 that with the second disc 321 are connected to slide on the sloping walls of the teeth 342, that of the fourth disc 341 , This causes an upward movement of the third disc 331 , the second disc 321 and the first disc 311 and the spring 351 will be curious.

This happens until the tips of your teeth 332 and 342 pass between the elements and then press the spring 351 return the element to the initial position. This, however, a section earlier than before, shows the position. The design of the adjustment mechanism, in particular the rotatable elements, makes it possible to achieve their mutual configuration which defines substantially the same force acting both during movement in the dose setting direction and during movement in the opposite direction. It should be noted, however, that depending on manufacturing tolerances of the elements in a given device, significantly smaller or larger deviations in this range may occur.

The mechanism can be used in an applicator, as in and . . discussed. The elements shown in FIGS. 5C and 50 may correspond to the elements shown in FIGS. 1 and 2, 1C, 1D. Corrugated surfaces which interact with each other, preferably toothed pulleys; the initial state is in explained.

During the dose adjustment, the housing 371 be the drive element. When the user starts to turn it by means of a button (in the direction indicated by the arrow in 68 is displayed), it causes a simultaneous rotation of the first rotatable disc 311 because the elements 371 and 311 with the fasteners 313 and 373 can be connected. As the first disc 311 not in relation to the case 371 she turns along with her, and her teeth 312 start on the sloping walls of the teeth 322 the second toothed disc 321 and simultaneously slide the first disc 311 moves up and biases the spring 351 , The second toothed disc 321 can be immobile with the third toothed disc 331 be connected. The third toothed disc 331 can with the fourth toothed disc 341 engage. The fourth toothed disc 341 can with the toothed wheel 361 and the mother 361 get connected. Consequently, the movement of the second toothed disc 321 be impossible. This happens until the tips of your teeth 312 and 322 pass each other and then the spring 351 and the first disc 311 pushes back to the initial position, but continues a section as in 6C shown.

To correct the dose, the case should be 371 in the direction opposite to the dose setting direction (that is, in the direction indicated by the arrow in FIG 60 shown direction). The first clutch disc 311 So it can not be in relation to the case 371 rotate.

These two elements are starting to turn. During the dose correction, the teeth can 312 the first disc 311 thus immovable with the teeth 322 the second disc 321 be engaged. The teeth 332 the third disc 331 that with the second disc 321 begin to slide on the sloping walls of the teeth 342; namely the fourth disc 341 that is an upward movement of the third disc 331 , the second disc 321 and the first disc 311 and a tensioning of the spring 351 causes. This happens until the tips of your teeth 332 and 342 pass between the elements and then press the spring 351 Return the element to the initial position, but a section earlier, to the position as in shown.

The design of the adjustment mechanism, in particular the rotatable elements, makes it possible to achieve their mutual configuration which defines substantially the same force acting both during movement in the dose setting direction and during movement in the opposite direction. It should be noted, however, that depending on manufacturing tolerances of the elements in a given device, significantly smaller or larger deviations in this range may occur.

The mechanism can be used in an applicator, as in the US Pat and discussed. The elements shown in FIGS. 5C and 50 may correspond to the elements shown in FIGS. 1 and 2.

Embodiment

- show another embodiment of the mechanism; - show the structure of an example of an applicator, this mechanism can be used, and the - show his way of working.

The mechanism can be a housing 471 (which may also be referred to as a coupling), which may preferably be rigidly connected to a dose setting element, for example in the form of a button (not shown in the drawing). A connecting element 402 connects the housing 471 with the dose setting element. The connecting element 402 may be in the form of a rod, sleeve, cylinder or other suitably shaped element. The connection may be through an end part of the connecting element, in this case a first end part 4021 the pole 402 , to be provided.

The mechanism may comprise a first coupling element. In this case, it may be a first clutch disc 411 act (which may also be known as a latch), which may be coaxial with the main axis X of the mechanism. The first disc 411 Can on her teeth 412 opposite side a lock 413 in the form of a projection, preferably a trapezoid.

For a safe angular position between the first disc 411 and the housing 471 is the castle 413 at a castle 473 of the housing 471 which may also preferably have a trapezoidal shape or other shape of narrowing legs. Preferably, the locks 413 . 473 have a shape of a plurality of protrusions, for example, three protrusions uniformly on the circumference of the first disc 411 and the housing 471 are arranged. For another angular positional relationship between the first disc 411 and the housing 471 the barrier 413 the first disc 411 is not due to the lock 473 of the housing 471 indicating what an axial movement of the first disc 411 to the housing 471 allows.

Between the first disc 411 and the housing 471 may be a torsion element, preferably a spring 451 , preferably a torsion spring or a torsion spring, or an arrangement of a torsion and compression element may be provided. The feather 451 can have two inboard end sections 452 and 453 each having projections on 474 of the housing 471 and at the lead 414 the first disc 411 can be hung.

The housing 471 , the pole 402 , the feather 451 and the first clutch disc 411 can be elements of the control arrangement 410 be. It can be connected to the dose setting element which allows the user to adjust or correct the dose to be applied.

The mechanism may also include a second coupling element. It can be a second clutch disc 421 be (which may also be referred to as a lock), which may be coaxial with the main axis X of the mechanism. The second clutch disc 421 can with the first clutch disc 411 be coupled. In this example, the element may have an interaction between the first disc 411 and the second disc 421 provides, the following: The teeth 422 the second clutch disc 421 in the opposite direction of the teeth 412 the first clutch disc 411 point; and can be engaged with them. Instead of the teeth 412 . 422 Other corrugated elements may be used.

The second clutch disc 421 can by means of a bolt 425 that with a latch 475 of the housing 471 cooperates with respect to the housing 471 be mounted axially fixed. A mother 461 can with the second clutch disc 421 be non-rotatable and non-slidably connected, which may be configured to a piston rod 404 to turn to dose the dose. The mother 461 can thus be an element of the dosing 460 of the mechanism.

During dose adjustment or correction, the elements rotate 402 . 411 . 451 . 471 and others stay motionless. The mechanism can with respect to the housing of the device by means of an actuating element 491 be held motionless. After releasing the actuator 491 (as shown in Fig. 8H), the lock of the mechanism can be released and force can be released which has accumulated in the drive spring, causing movement of the piston 404 through the thread of the element 461 is effected.

A locking element 481 may be mounted in a set position with respect to the housing of the applicator, and preferably does not rotate during dose setting or correction or during dose dosing. It may preferably be a bearing element.

The mechanism according to this embodiment operates as follows:

In the in shown initial position, the first 411 and the second clutch disc 421 kept at rest and blocked by the latch 473 of the housing 471 and the lock 413 the first disc 411 , The initial tension of the spring 451 causes the setting of the position of the first disc 411 in relation to the housing 471 ,

During the dose setting, when the user turns the knob, it causes the housing to rotate 471 , This movement causes a movement of the housing 471 at a certain angle with respect to the first disc 411 , which is done by peeling off the spring 451 can be accompanied. At the same time, the locks can 473 and 413 also be moved by the same angle and the first disc 411 can no longer be blocked in the axial direction, as shown in FIG. 88.

The first disc 411 can through the lead 414 be predetermined, in a recess 475 the clutch 471 lies. When these elements reach their limit of movement, they continue to move together (as shown in Fig. 8C) in the axial direction. It moves so that his teeth 412 via a subsequent toothing 422 the second disc 421 jump and take subsequent engagement positions. The feather 451 may here be an axially flexible element that the first disc 411 causes them to move, as shown in FIG. 80 (first disc 411 is raised, the spring 451 is compressed) and in Fig. 8E is the first slice 411 to the second disc 421 pressed; the feather 451 is relaxed.

The rotation occurs as long as the user acts with force on the dose setting element. When the user completes his action, the spring causes 451 by means of the curved end sections 452 and 453 a locking of the device at the currently set value, ie it causes the projections 474 and 414 to return to their equilibrium state. The locking of the assembly is achieved by the latches 473 and 413 be arranged opposite each other again, as in the and shown. The correction movement is analogous, requiring rotation of the dose setting member by the user in a direction opposite to the dose setting direction. The forces that accompany both movements (adjusting and correcting) can be essentially the same. After adjusting the dose, it may be possible to trigger the delivery of the dose by the actuator 491 is pressed down, causing a Entblockierung the entire arrangement due to the force. The drive spring begins to rotate and is threadedly connected to the piston rod 404 moved to an appropriate value in the axial direction, resulting in 8H is shown.

In this embodiment, the housing 471 an element of the control arrangement 410 which can be connected to a dose setting element. And at the same time it may be an element of the drive assembly connected to the drive spring 420 be with the case 471 can be connected. mother 461 can with the second clutch disc 421 be an element of the dosing with the piston rod 404 connected to dose the dose. The control arrangement can with the dosing by means of a spring element 451 be coupled, which during the rotation of the dose setting button undergoes a deformation in the decoupled position and blocks a displacement of the control arrangement with respect to the dosing and in the coupled position blocked. In other words, in this embodiment, the adjustment mechanism can comprise at least four rotatable elements ( 402 . 411 . 421 . 451 . 461 . 471 ) which are interconnected.

The rotatable elements ( 402 . 411 . 451 . 471 ) may be rotatable during dose setting or reduction for a metering device. The first rotatable element ( 411 ) may be a receiving element having waves, and the second rotatable element ( 421 ) may comprise shafts which cooperate with the shafts of the first rotatable element, which shafts may be shaped to allow rotation: at least four ( 402 . 411 . 421 . 451 . 461 . 471 ) Rotatable elements during the dose delivery through the metering device.
++ =

After releasing the actuator 491 (as shown in FIG. 8H), the lock of the mechanism can be released and it can rotate through the force accumulated in the drive spring, causing movement of the piston 404 through the thread of the element 461 is effected.

A locking element 481 may be mounted in a set position with respect to the housing of the applicator, and preferably does not rotate during dose setting or correction or during dose dosing. It may preferably be a bearing element.

The mechanism according to this embodiment operates as follows.

In the in 8A shown initial position become the first clutch disc 411 and the second clutch disc 421 kept at rest and blocked by the latch 473 of the housing 471 and the lock 413 the first disc 411 , The initial tension of the spring 451 causes the setting of the position of the first disc 411 in relation to the housing 471 ,

During the dose setting, when the user turns the knob, it causes the housing to rotate 471 , This movement causes a movement of the housing 471 at a certain angle with respect to the first disc 411 what through one Pulling off the spring 451 can be accompanied. At the same time, the locks can 473 and 413 also be moved by the same angle, and the first disc 411 can no longer be blocked in the axial direction, as shown in FIG. 88.

A maximum angle of movement of the housing 471 concerning the first disc 411 can through the lead 414 be predetermined, which is in a recess 475 the clutch 471 emotional. As these elements reach their limit of movement, they continue to move together as shown in FIG 8C ,

Because the first disc 411 can be unlocked in the axial direction, it moves so that their teeth 412 over subsequent teeth 422 the second disc 421 jump, taking subsequent engagement positions. The feather 451 can here be a flexible element in the axial direction, which is the first disc 411 causes them to move, as shown in FIG. 80 (first disc 411 is raised, the spring 451 is compressed) and in Fig. 8E is the first slice 411 to the second disc 421 pressed, the spring becomes 451 solved).

The rotation occurs as long as the user applies force to the dose setting member. When the user finishes his action, the spring becomes 451 by means of
the curved end sections 452 and 453 cause blocking of the device at the currently set value,
H. it causes the protrusions 474 and 414 to return to their equilibrium state. The locking of the assembly is achieved by the latches 473 and 413 be arranged opposite each other again, as in the 3 and 4 shown. 8F and 8G.

The correction movement takes place in an analogous manner, requiring rotation of the dose setting element by the user in a direction opposite to the dose setting direction. The forces that accompany both movements (adjusting and correcting) can be essentially the same.

After adjusting the dose, it may be possible to trigger the delivery of the dose by the actuator 491 is pressed down, which causes a Entblockierung of the entire assembly, which begins to rotate due to the force of the drive spring and by a threaded connection with the piston rod 404 moves it by a suitable value in the axial direction, which is in 8H is shown.

In this embodiment, the housing 471 at the same time an element of the control arrangement 410 which may be connected to a dose setting element, and at the same time may be an element of the drive arrangement 420 be connected to the drive spring, which is connected to the housing 471 can be connected. The mother 461 can work together with the second clutch disc 421 the elements of the metering be that with the piston rod 404 connected to dose the dose. The control arrangement can with the dosing by means of a spring element 451 be coupled, which undergoes a deformation in the decoupled position during rotation of the dose setting knob and allows a shift of the control arrangement with respect to the dosing and in the coupled position blocks the control arrangement with respect to the dosing.

In other words, in this embodiment, the adjustment mechanism can comprise at least four rotatable elements (FIG. 402 . 411 . 421 . 451 . 461 . 471 ) connected to each other, the rotatable elements ( 402 . 411 . 451 . 471 ) may be rotatable during dose adjustment or reduction for a metering device. The first rotatable element ( 411 ) may be a receiving element having waves, and the second rotatable element ( 421 ) which cooperate with the shafts of the first rotatable member, which shafts may be shaped to allow rotation of at least four 402 . 411 . 421 . 451 . 461 . 471 ) Rotatable elements during the dose delivery through the metering device.

The mechanism may be in the applicator, as in the and discussed, be applied. 1C, 1D - those in Figs. 7F and 7G may be equivalent to those described in Figs 7 and 8th are shown.

Embodiment

shows a further embodiment of the mechanism, and 1 OA 1 OH shows his operation.

The mechanism may comprise a first coupling element. It may be the first clutch disc 511 (which may be referred to as a return plate), which may be coaxial with the main axis X of the mechanism and which may be connected to a dose setting element, for example in the form of a button (not shown in this drawing).

A connecting element 502 connects the disc 511 with the dose setting element. The connecting element 502 For example, it may be a rod, sleeve, cylinder or other suitably shaped element. The connection can be made through the end part of the connecting element, in this example, a first end part 5021 the pole 502 , to be provided. At the second end part of the connecting element projections can 5024 be present with the recesses 514 the first cooperate disc in which they can be arranged substantially without clearance.

The mechanism may further comprise a second and a third coupling element. This embodiment may be a second disc 521 act (which can be referred to as a drive disc) and the third disc 531 which may be coaxial with the major axis X of the mechanism and on the opposite sides of the first disc 511 can be arranged. In another example, only one plate may be provided. The working principle is based on the second disc 521 discussed, it should be remembered that the third disc 531 does an analogous work. The second disc 521 can be a spring element 522 comprise, in this example, an elastic arm, but it may also be another spring element, such as a torsion or compression spring.

In the slices 521 . 531 can recesses 524 and 534 be present with the tabs 5024 in the connecting element 502 cooperate and the torque from the dose setting on the discs 521 . 531 transfer. The recesses 524 . 534 can be larger than the protrusions 5024 , whereby a free rotation of the connecting element 502 in relation to the disc 521 . 531 in a certain limited area. In the first disc 511 can corrugations in the form of recesses (traces) 513 be present, which is possible in this embodiment.

Shaped wave elements may be arranged which preferably have matching recesses and protrusions which provide contact through cooperating surfaces, preferably in the form of rolling elements 581 , In this embodiment, they comprise a cylinder with a recess (which preferably provides symmetry) shown as a core 582 in a shape of a cylinder with a first diameter. Cylindrical heads 583 . 584 may be disposed at the end portions of the core (preferably symmetrical to each other) and have a second diameter which is larger than the first diameter.

The first disc 511 with the rod 502 Thus, elements of the control arrangement 510 of the mechanism.

The mechanism can also be a rail 571 (which may be referred to as a skid track) which may be coaxial with the major axis of the mechanism and may be a corrugated inner surface of the cylindrical ring. This element may have shaped surfaces (they may be corrugated, e.g., sinusoidal, in the form of a cam curvature or grooved, for example) that may be substantially symmetrical (the resistance of the contact surfaces may therefore be substantially the same). Consequently, movement in one direction as well as in the opposite direction (adjustment movement and motion reduction) may be accompanied by a substantially equal force.

The recesses 572 the train 571 preferably have a radius equal to the radius of the heads 583 . 584 the rolling elements 581 equivalent. They can also have a different shape - a rack in the return disc, a brake track and a rolling element. A nut (not shown to simplify the drawing) for driving the metering piston of the adjusted dose may be with the track 571 be connected. Thus, the track can 571 an element of the dosing arrangement 560 be.

The drive spring can directly or indirectly via an intermediate element with the second disc 521 and / or with the third disc 531 be connected. Thus, the second disc can 521 and / or the third disc 531 an element of the drive assembly 520 be.

In this embodiment, the control arrangement 510 thus with the metering device 560 be coupled by means of the spring element, which deforms during the rotation of the dose setting in the decoupled position and a movement of the control arrangement 510 in terms of dosage allows arrangement 560 and in the coupled position, the rotation of the control assembly 510 with respect to the dosing arrangement 560 To block.

In other words, in this embodiment, the adjustment mechanism can comprise at least four rotatable elements (FIG. 502 . 511 . 521 . 531 . 571 . 581 ) connected to each other, with rotatable elements ( 502 . 511 . 521 . 531 . 581 ) can also be rotated

Dose adjustment or reduction for the dosing device. The first rotatable element ( 511 . 571 ) may be a receiving element and may have waves, and the second rotatable element ( 581 ) may have waves which cooperate with waves of the first rotatable element, wherein the waves may be shaped so as to allow a rotation of the at least four ( 502 . 511 . 521 . 531 . 571 . 581 ) Rotatable elements during the dose delivery through the metering device.

The mechanism according to this embodiment operates as follows:

The main principle of operation is analogous to the functional principle of a unidirectional bearing, also called freewheel or directional clutch. The unidirectional bearing mechanism can be used to transmit torque in one direction and allows free relative movement in the second direction.

The rollers of the mechanism may be wedged between the outer ring and the inner ring, and the working surfaces of these rings may be a self-locking angle. The rollers can be pushed by means of push elements, such as springs and slides, individually on the track of the ring, which causes an immediate effect, wherein the resulting only from the elastic deformations of the coupling elements dead angle is close to zero.

The mechanism according to this embodiment operates as follows:

During rotation in the dose setting direction, the mechanism is free to move to subsequent angular positions. Upon rotation in the opposite direction - the reduction roll - between the outer web, preferably in the form of a cylinder, and the inner surface in the form of a portion of a sloped rail, a force wedges the working elements, such as rollers. Spheres or other elements that allow rolling, translation or rotation. The mechanism is blocking immediately. By modifying this solution, a locking effect of the mechanism can be achieved so that the drive spring force can not retract the set dose by itself.

The stopping of the mechanism in one position at each single dose may be due to the corrugated surface of the web 571 the brake be allowed, with the recesses 572 cause a locking of the mechanism in certain positions, as in 10A shown.

When the return disc 511 in a by the arrow in 10B moving at given direction, can be a pressure of the track 513 on the smaller core 582 of the rolling element 581 caused, wherein at the same time the spring element 522 is tense. This is possible because the drive pulley 521 and the return disc 511 different recesses 524 . 514 exhibit that with the projection 5024 interact of the connecting element.

Therefore, their mutual position under the action of the connecting element 502 change, like in the and is set forth. The drive pulley 521 may comprise spring elements - in the form of elastic and flexible arms (which may be formed in different shapes, or these may be different spring means, for example a spring, a bent material, etc.).

Therefore, the returning plate 511 during the entire movement of the connecting element 502 in both directions with the connecting element 502 connected, and the drive pulley 521 can with a small distance with the connecting element 502 be connected. The rolling elements 581 can simplify the manufacturing and assembly technology by a connecting element 591 be connected as in 10E shown. During delivery of the set dose, the entire mechanism rotates, especially after release of the spring drive means. The mother also turns. The adjustment mechanism acts radially. In particular, the spring elements act such that the elements act with shaped waves; especially those that block the mechanism (in this example, the rolling elements 581 polygonal, for example, triangular, be coupled in a rhombus).

They include surfaces which interact with the rotatable element (guide pulley, return pulley, brake track). The rotation of all elements in is ensured during injection. During adjustment or reduction, the above-mentioned elements rotate except for the track of the brake (it remains fixed with respect to the housing). In this example, two drive pulleys 521 . 531 be used. This makes it possible to compensate for forces acting on the rolling elements, in addition, so that there is no buckling, as in the and 3 shown.

FIGS. 11A-11D show another embodiment of the mechanism, and FIGS to show its functioning. The mechanism may comprise a first coupling element. It may be a first movable element, preferably rotatable, preferably a clutch disc 611 that can be coaxial with the main axis X of the mechanism. The first clutch disc 611 may be connected to a dose setting element, for example in the form of a button (not shown in this drawing).

The dose setting element can by means of a connecting element 602 be associated with the mechanism to transmit a force from a user to the mechanism. The connecting element 602 For example, it may be a rod, sleeve, cylinder or other suitably shaped element. The connecting element 602 and the first clutch disc 611 can be elements of the control arrangement 610 be. The control arrangement 610 may be connected to the dose setting element, by means of which the user can select or correct a dose to be applied. These elements may be connected by inlets / keys, protrusions or other means providing a secure connection.

The connecting element 602 and the first clutch disc 611 may be separate elements that are axially movable relative to each other. In this example, the first clutch disc 611 in the form of a ring with inlets 6111 be formed, which are formed in its inner path, with longitudinal projections 6021 cooperate, which at the end portion of the connecting element 602 are shaped.

The mechanism may also include a second coupling element. It can be a second clutch disc 621 which may be coaxial with the main axis X of the mechanism. The second clutch disc 621 can with the first clutch disc 611 be coupled. In this example, the element that controls the interaction between the discs 621 and 611 provides the corrugated element, preferably in the form of shaped waves, preferably in the form of teeth 622 the second clutch disc 621 are; in the opposite direction than the teeth 612 the first clutch disc 611 directed and engaged with these. In this embodiment, the teeth are 612 . 622 from the disc in the axial direction. The shape of the teeth 622 the second disc 621 must be the shape of the teeth 612 the first disc 611 but their count can be lower.

The drive spring (not shown in this drawing) can be connected to the connecting element 602 be connected, which is an element of the drive assembly 620 can be. The drive spring may directly or through additional connecting elements with the drive assembly 620 be connected.

A nut (not shown in this drawing) is present, with a shaped opening 624 can be coupled by a locking element 682 with the shaped opening 624 with the second clutch disc 621 get connected. The nut can be configured to rotate the piston and the rod meters the set dose (not shown in this drawing). The second clutch disc 621 may therefore be an element of the dosing 660 of the mechanism.

The second clutch disc 621 can on the inner surface of a cylindrical sleeve 623 be formed, the inlet and outlet may be limited by the lock.

Between the first clutch disc 611 and the locking elements 681 . 682 For example, pressure elements may be attached to the first clutch plate 611 in one with the second clutch disc 621 However, decoupling to allow both axial directions along the main axis X of the mechanism. In this example, the printing elements can be compression springs 651 . 652 but the pressure elements may also be another type of spring element which is a separate element or integral component of at least one of the other elements. For example, there may be elastic protrusions in the first clutch disc 6111 or other elements are formed.

In this embodiment, the control arrangement 610 therefore with the dosing 660 by means of the spring elements 651 . 652 be coupled, which deform during the rotation of the dose setting knob in a decoupled position and a movement of the control arrangement 610 allow - the metering arrangement 660 , and in the coupled position they block the rotation of the control assembly 610 with respect to the dosing arrangement 660 ,

The feathers 651 and 652 may rotate during dose adjustment or correction. They can also be integral with the element 611 connected (in this case, they turn simultaneously); Alternatively, they can also be integral with the elements 681 and 682 connected (in which case they will not rotate during the dose setting or correction).

In other words, in this embodiment, the adjustment mechanism can comprise at least four rotatable elements (FIG. 602 . 611 . 621 . 651 . 652 . 681 . 682 ), which are connected to each other, wherein the rotatable elements ( 602 . 611 . 651 ) while the dose setting is rotatable or reducing for the metering device. The first rotatable element ( 611 ) may be a receiving element and may have waves, and the second rotatable element ( 621 ) may also comprise shafts which cooperate with shafts of the first rotatable member, which shafts may be shaped to allow rotation thereof, at least four 602 . 611 . 621 . 651 . 652 . 681 . 682 ) rotatable elements are in play during the dose delivery by the metering device.

The mechanism according to this embodiment operates as follows.

The first clutch disc 611 is in its rest position with the second clutch disc 621 coupled and the discs can in this state through the springs 151 . 152 held simultaneously from both sides on both discs 611 . 621 just press the first disc 611 can move axially, the engaged arrangement remains in an in 12E shown equilibrium state. On the other hand, all elements stay in 11A rotatable (especially during injection).

The disks 611 . 621 include the tooth contact surfaces 612 . 622 , between them at a certain angle, during the dose adjustment by means of the rotation of the coupling element 602 they are in a direction caused by the movement between Fig. 12A and comes. A compression of a spring 652 (where the spring 651 not deformed in this case) and the first disc 611 moves axially in the compression direction of this spring 652 ( 128 ) - until the time of decoupling with the second disc 621 ( 12C ).

During the further rotation of the mechanism causes the spring 652 that the first disc 611 moved to the initial position and more teeth of the disc couples ( 120 ). The movement in the opposite direction may be analogous, but requires the rotation of the coupling element 602 ,

In the opposite direction, which is a movement of the first disc 611 in the direction it causes a compression of the second spring 651 causes (where the spring 652 not deformed). The configuration of the rotatable elements may account for an equal (substantially) force acting in the dose setting direction and in the opposite direction. In particular, the interaction of the two springs with the element 610 be substantially the same (ie, the pressing may be the same regardless of the direction). Possible differences in force could thus be caused by targeted selection of spring means with differentiated properties.

OTHER EMBODIMENTS

Possible further embodiments are possible, which comprise an arrangement of elements two or more of the embodiments described above.

Further, the rotatable elements may be a disk, a rim, a disk, a ring, a tire, a roller, a sleeve, a circular member, or another form of molded member that allows for rotation, irregular or non-circular shapes.

Further, the corrugations (substantially regularly) in corrugated members may take the form of teeth, deformations, burrs, bends, cams, inlets, protrusions, protrusions, depressions, depressions, reliefs, cutouts, notches, grooves, curves, claws, or as centers , Sprockets, ribs, hooks / hooks, inlets, protrusions or threads. They can be trapezoidal, V-shaped, triangular, curved, sinusoidal!

The shafts may be configured to abut each other at least partially, thereby ensuring rotation of a corrugated member through the abutting corrugated member.

The corrugations may be configured to require substantially the same force for dose adjustment and correction of the dose, in both a symmetrical and an asymmetric form.

The shafts may form a pawl, they may also not be latching, with play or no play, rubbing or interfering, connected vertically or horizontally, axially, forwards or radially.

The corrugated elements may be movable, including rotatable, axial, forward and radial.

The corrugated elements can be coaxial.

The corrugated elements may be symmetrical or asymmetrical. The corrugated elements may have differentiating ribs.

The corrugated elements may comprise connecting elements, connecting projections. They can include any shapes configured to connect and couple on contact.

The corrugated elements may be disposed on disks forming separate elements or on the housing of other elements of the mechanism or on the housing of the injector or other cooperating element.

The waves may be on the outer or inner surface of the element.

Number of waves or a different amount.

The cooperating corrugated elements may have corrugations of the same or different shape. The direction of the waves indicated in the respective examples can be changed be, preferably to the opposite shape. The mechanism may comprise at least two rows or rows of corrugated elements. The waves of at least two rows or rows of corrugated elements may have different heights, different slopes or different amplitude or period. At least two rows or rings of corrugated elements may have different coupling strengths. In a particular case, the coupling strength of corrugated elements is the same.

The number of waves on a corrugated surface may be a plurality of the number of corrugations on the cooperating second corrugated surface, for example when on a surface 7 Waves are present, then on the second surface 7 . 14 . 21 , etc. The locations of the waves on the cooperating elements may be interchangeable (especially if they differ in the number of waves, for example in the case of connections of mutually divisible waves, as discussed above).

The configuration of the rotatable elements, including those comprising corrugated elements, allows connections that define substantially the same force during adjustment and / or correction. Deviations and differentiations can e.g. the accuracy of manufacture and assumed (or actual) tolerances of certain components of the metering device; or the additional resistances that occur (eg, uneven wear of the elements) or interaction with other elements in the device. The clutch discs can take any desired engagement positions, which cooperate with at least one receiving surface (force-locking, latching).

The spring element of the mechanism may be any spring means such as a torsion spring, compression spring, disc spring, clock spring, disc spring, rebound spring, curved plate (suspension spring), coil spring, a molded elastic member of material having elastic properties, etc.

The coupling between the elements of the mechanism may take various forms, for example there may be claws / a dog clutch between the elements. The coupling mechanism can also be analogous to the publication US2667252 to be shown. The coupling may thus comprise at least three cooperating rotatable elements, including at least one disc.

Under the device for injecting the actuator are any Dosieraktivierungsmittel to understand, in the form of release means, locking means, locking means, in particular a button, a trigger, a trigger on the side cheek of the device.

The button can be moved between passive and active positions - when moved to the active position, the dose display can be rotated in one direction.

Zero dose and dose injection.

Returning the button to the passive position may cause the end of the dose injection. The device may include various types.

Dose indicators, including indicators of a digital type, a number-type, a letter-type or in the form of a line, which are positioned along a circle or a helix on a threaded scale. Or that slidingly moves, as a counting wheel in the device, may be performed by elements, mechanisms or drive elements using individual elements or their arrangements, including drive nuts.

The drive nut may be axially rotatable or movable. The piston rod driven by the nut may be axially movable or movable and rotatable. The injection device according to at least one of the discussed examples can be used as follows. A cap of the injector should be removed. A cartridge shield should be unscrewed counterclockwise from the injector body.

The insertion plate should be screwed clockwise to the housing of the injector. An outer needle shield should be screwed clockwise against the insertion plate. If priming is required, the dose setting element should be rotated clockwise. When a certain number appears in the dose display window (eg 2 units), the rotation of the dose selector ends.

The injector should be adjusted so that the needle points upwards. The actuator should be moved with a thumb towards the needle. The actuator should be held until the indicator (eg, in the form of a green dot) appears in a window of the injection end buzzer. If no drop of substance (e.g., growth hormone) appears at the end of the needle, the activities are repeated. If, after some attempts, no drop appears, the needle should be removed and a new needle should be attached.

Before using the injector for the first time, a test dose should be set after replacing the cartridge. To do this, the dose setting element should be rotated clockwise until the desired number appears in the window, which corresponds to the number of fluid preparation units. If one chooses too many units, the dose can be corrected. The end of the needle should be inserted into the subcutaneous tissue. The actuator should be pressed with a thumb in the direction of the needle. The actuator should be held until the end of the injection. The end of the injection may be indicated by the appearance of the indicator (eg a green dot) in the buzzer window. The user waits for a certain period of time, e.g. By counting to 10. At the end, the needle should be removed.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• EP 1351732 B1 [0003]
• EP 1926514 B1 [0004]
• PL 211266 B1 [0005]
• WO 2006/045526 [0006]
• US 2015112274 A1 [0007]
• WO 2014033195 [0008]
• WO 2015055640 [0009]
• EP 1458440 B1 [0088]
• EP 2274032 B1 [0088]
• WO 2013119132 [0089]
• EP 1954337 [0089]
• WO 2006126902 [0089]
• PL 215310 [0103]
• PL 214940 [0125]
• WO 2009105909 [0133]
• EP 2451508 [0133]
• WO 2015071289 [0133]
• US 2667252 [0294]

Cited non-patent literature

• ISO 11608-1: 2014 [0012]

Claims (31)

An adjustment mechanism for a metering device, in particular for metering pharmaceutical or therapeutic fluids, wherein the adjustment mechanism comprises at least four interconnected rotatable elements, wherein: - At least two rotatable elements in setting or correcting a dose for the metering device are rotatable; - A first rotatable element is a receiving element and having corrugations; a second rotatable element or a third rotatable element or a fourth rotatable element has corrugations which are coupled to the corrugations of the first rotatable element; wherein the corrugations are shaped to allow rotation of the at least four rotatable members during delivery of the dose by the metering device. Adjustment mechanism after Claim 1 wherein the rotatable elements form: a control arrangement for connecting the adjustment mechanism to a dose setting element of the dosing device; a drive arrangement for connecting the adjustment mechanism to a drive element of the dosing device; and a metering arrangement for connecting the adjustment mechanism to a metering element of the metering device; wherein the control assembly is coupled to the metering assembly by a spring member which can deform from a coupled position to a decoupled position during rotation of the metering adjustment knob, wherein in the decoupled position the spring member is configured to detect movement of the control assembly with respect to permitting the metering assembly, and wherein the spring member is configured in the coupled position so as to block rotation of the control assembly with respect to the metering assembly. The adjustment mechanism of any of the preceding claims, wherein the rotatable elements are configured to substantially define a force that acts during movement in a direction corresponding to a dose setting and is equal to a force opposing movement in one of the dose direction Direction ensures. Adjusting mechanism according to one of the preceding claims, wherein at least two rotatable elements and preferably three rotatable elements of the adjustment mechanism are substantially immovable to each other. Adjusting mechanism according to one of the preceding claims, wherein at least one rotatable element is a spring element or a member having an elastic portion. The adjustment mechanism of any one of the preceding claims, comprising at least five interconnected rotatable members, wherein at least three rotatable members are rotatable in adjusting a dose or reducing a dose for the dosator and at least two members having corrugations shaped to be during delivery of the dose by the metering device allow rotation of the at least five rotatable elements. Adjusting mechanism according to one of the preceding claims, comprising a nut which is connected to the first rotatable member or with the second rotatable member to drive a piston rod of the metering device. Adjustment mechanism according to one of the preceding claims, wherein at least one rotatable element of the adjustment mechanism is movable by axial or radial sliding. Adjusting mechanism according to one of the preceding claims, wherein the spring element is formed separately from the drive element of the metering device. Adjusting mechanism according to one of the preceding claims, wherein at least two rotatable elements are corrugated elements which at least partially abut each other in the coupled position, and which are spaced apart in the decoupled position. Adjustment mechanism after Claim 10 wherein the corrugated elements comprise axially projecting protrusions. Adjustment mechanism according to one of Claims 10 to 11 wherein the corrugated members comprise radially protruding protrusions. Adjustment mechanism according to one of Claims 10 to 12 wherein the corrugated elements have friction surfaces or detent surfaces or toothed surfaces or connection surfaces. Adjustment mechanism according to one of Claims 10 - 13 wherein the corrugated elements cooperating with each other are coaxial and have corrugations arranged on parallel planes. Adjustment mechanism according to one of Claims 10 to 14 comprising at least two Rows, series or rings of corrugated elements, preferably arranged in a circular arrangement, on rotatable disc elements, preferably with a common centering axis, which abut each other or are spaced from each other. Adjusting device according to Claim 15 wherein the corrugations of the at least two rows, series or rings of the corrugated elements have different heights or different angles of inclination. Adjustment mechanism according to one of the preceding claims, wherein at least one of the rotatable elements forms part of a dog clutch. Adjustment mechanism according to one of Claims 10 - 17 wherein the corrugated members abut each other during rotation of the drive member in a dose setting direction and are separated from each other during rotation of the drive member in a dose correction direction. Adjustment mechanism according to one of Claims 10 to 18 , wherein the number of corrugations in the corrugated elements of the control arrangement differs from the number of corrugations of the corrugated elements of the metering unit. Adjustment mechanism according to one of the preceding claims, wherein the spring element rotates in relation to the metering device according to the rotation of the dose setting element of the metering in dose setting and / or in the direction of dose correction. Adjusting mechanism according to one of the preceding claims, wherein the dose setting element is preferably substantially directly coupled to the same coupling element which couples the adjustment mechanism. Adjusting mechanism according to one of the preceding claims, wherein the metering arrangement comprises a nut connected to the metering device, preferably a piston of the metering device, wherein the nut is coupled to at least one rotatable element of the control arrangement and / or the metering device. Adjustment mechanism according to one of the preceding claims, wherein the control arrangement and the metering arrangement have at least one common element. Adjustment mechanism according to one of the preceding claims, wherein the spring element is a torsion spring, a compression spring or a spring torsional compression spring. Adjusting mechanism according to one of the preceding claims, wherein the spring element is radially deformable. Adjusting mechanism according to one of the preceding claims, wherein the spring element is axially deformable. Adjusting mechanism according to one of the preceding claims, wherein the spring element is an elastic portion of a rotatable member which is rotatable with respect to the metering device. Dosing device, in particular a reusable injector, in particular for growth hormones, comprising: a housing comprising a portion configured to receive a container of liquid to be dispensed; a dose setting element coupled to the housing; a piston for dispensing a set dose of the liquid; - elastic drive means providing energy to cause movement of the piston to cause the outflow of the substance; - The adjustment mechanism according to one of the preceding claims. Device after Claim 28 wherein the adjustment mechanism is configured to cooperate with at least one non-driving elastic member, the non-driving resilient member preferably influencing movement of a member having shaped corrugations, the surface of the formed corrugations contacting a surface of the non-driving elastic member; and wherein the non-driving elastic member is subjected to rotation during movement in a direction corresponding to or opposed to the adjustment direction. Device according to one of Claims 28 - 29 wherein the dose setting element, preferably directly, is substantially coupled to the same coupling element that couples the adjustment mechanism. Device according to one of Claims 28 to 30 , wherein the drive element is an elastic element, in particular a torsion spring.

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