Adjustment tool for a pre-filled handheld device for dispensing a pharmaceutical substance, arrangement of the handheld device in the adjustment tool and method of adjustment by the adjustment tool

Abstract

The present invention relates to an adjustment tool (1) for adjusting the position of an adjustment component (2) during the installation of an adjustment component (2) into a pre-loaded handheld device (5) for dispensing a drug substance in multiple doses, wherein the handheld device (5) comprises: a housing (6) having an outer shell component (7), an inner shell component (8), and a mouthpiece (9) for the user to inhale the drug substance; and a drug cartridge (11) contained in the housing (6) and containing the drug substance, wherein the inner shell component (8) is movably arranged within the outer shell component (7), wherein the drug cartridge (11) is movably arranged within the inner shell component (8), and wherein the adjustment component (2) is movably connected to the inner shell component (8) to apply force to the drug cartridge (11). To provide automatic adjustment of the adjustment component (2) to accommodate different medicine cartridges (11), an adjustment tool (1) is proposed, comprising a positioning component (13) for mounting at least a portion of a handheld device (1) and applying force to the adjustment component (2) of the handheld device (1), wherein the positioning component (13) includes an indicator element (14) movably arranged on a support component (27) of the positioning component (13) to indicate the current position of the adjustment component (2) relative to the medicine cartridge (11).

Description

Technical Field

[0001] This invention relates to an adjustment tool for adjusting the position of an adjustment component when it is installed in a pre-loaded handheld device for dispensing medication. The handheld device includes: a housing having an outer shell component, an inner shell component, and a mouthpiece for the user to inhale the medication; and a cartridge containing the medication and housed within the housing, wherein the inner shell component is movably disposed within the outer shell component, the cartridge is movably disposed within the inner shell component, and the adjustment component is movably connected to the inner shell component to apply force to the cartridge.

[0002] Furthermore, the present invention also relates to an arrangement of a handheld device having a pharmaceutical cartridge containing a pharmaceutical substance, the arrangement being located in an adjustment tool for adjusting the force applied to the pharmaceutical cartridge.

[0003] Furthermore, the present invention relates to a method for adjusting the position of an adjusting component in a pre-loaded handheld device for dispensing drug substances in multiple doses using an adjusting tool, wherein the handheld device comprises: a housing having an outer shell component and an inner shell component movably disposed within the outer shell component; a drug cartridge containing the drug substance surrounded by the inner shell component; and the adjusting component. Background Technology

[0004] The handheld device specifically described herein is referred to as an inhaler. Such an inhaler should deliver the substance to the user only at the dispensing position of the handheld device when the user has already placed the mouthpiece in their mouth and is inhaling. During inhalation, the cartridge moves from a rest position to the dispensing position relative to the housing of the handheld device. When moved to the dispensing position, the valve of the cartridge is pressed into the cartridge against the force of a valve spring, thereby drawing a predetermined amount of the drug substance from the cartridge. This substance is typically under pressure. For example, references can be made to EP2275479A1 and US2016 / 0084385A1 regarding such cartridges and valves. These descriptions are equally important for the handheld devices disclosed herein.

[0005] To ensure the dispensing of the drug substance, an adjusting component (such as a spring element) is used to apply force to the cartridge. This can compensate for minor height tolerances between different cartridges (especially those from different manufacturers).

[0006] Differences in the height of the cartridge can cause various problems with the performance of the handheld device. Therefore, the adjustment components preferably need to be positioned differently within the housing of the handheld device to apply optimal pressure to the cartridge, thereby enabling the cartridge to move from a rest position to a dispensing position and thus to extract a predetermined amount of substance from the cartridge.

[0007] Typically, the individual height of the medicine cartridge to be placed in the handheld device needs to be manually checked in order to adjust the position of the adjustment components within the handheld device housing. However, this is both inconvenient and time-consuming. Summary of the Invention

[0008] Therefore, the present invention aims to provide an adjustment tool for determining and adjusting the position of an adjustment component in a handheld device.

[0009] To achieve this objective, an adjustment tool is proposed, comprising a positioning member for clamping at least a portion of a handheld device and applying force to an adjustment member of the handheld device, wherein the positioning member includes an indicator element movably arranged on a support member of the positioning member to indicate the current position of the adjustment member relative to the drug cartridge.

[0010] This adjustment tool allows for manual or automatic assembly of the handheld device with respect to the position of the adjustment component within the housing. The adjustment tool may also provide, for example, a base component for mounting a first portion of the handheld device, and a positioning component for holding at least a second portion of the handheld device. The base component is typically used to mount the lower portion of the handheld device, which contains a mouthpiece through which the user can inhale a medication. The positioning component is preferably designed to mount the top side of the handheld device opposite the mouthpiece. This top side of the handheld device can, in particular, be opened by the manufacturer to insert a medication cartridge into the handheld device and to insert the adjustment component into the housing. The top side of the housing is typically closed by a cap. The base component is not necessarily a mandatory component of the adjustment tool itself. Instead, the base component can be part of other devices or tools.

[0011] The positioning component of the adjustment tool can be moved relative to the handheld device, particularly by moving the positioning component along a guide (e.g., a guide connecting the positioning component to the base component of the adjustment tool or other tools or devices). The adjustment tool is preferably operated by an actuator or includes an actuator capable of moving the positioning component. A guide can be used, such as a guide comprising one or more supports connected to both the base component and the positioning component of the adjustment tool. For example, the supports of the base component can be inserted into corresponding bushings or through holes in the positioning component. However, other types of connections between the base component and the positioning component can also be used, such as mortise and tenon joints or others. The key point is that the positioning component can be easily moved relative to the base component to individually fix its position relative to the base component. This also allows force to be applied to the positioning component to adjust the position of the adjustment component within the handheld device housing.

[0012] The positioning component includes an indicator element for indicating the position of the adjusting component within the housing (particularly relative to the cartridge). This ensures that the adjusting component can apply sufficient force to the cartridge, regardless of the individual height of the cartridge and thus the position of the top of the cartridge in the dispensing position. Proper adjustment of the adjusting component's position within the handheld device housing ensures that the cartridge reaches the same dispensing position regardless of its individual height. This, in turn, ensures that the same amount of medication is dispensed from the cartridge with every operation of the handheld device.

[0013] The indicating element is part of the positioning component and is movable relative to the support component of the positioning component. Based on the current position of the indicating element relative to the support component, the adjustment tool can infer the current position of the adjustment component relative to the drug cartridge, thereby determining whether the adjustment component is correctly assembled within the handheld device housing.

[0014] The indicating element is positioned against the inner housing of the handheld device so that the current position of the adjusting member is indicated by the movement of the inner housing relative to the adjusting member. When the adjusting member (e.g., screwed in) moves into the inner housing, the inner housing will not move relative to the positioning member as long as the adjusting member has not contacted the cartridge and / or the cartridge has not reached its lowest position within the handheld device housing. This means, for example, that the adjusting member is screwed into the internal thread of the inner housing until it contacts the top of the cartridge. Then, since the cartridge and the adjusting member can no longer move further into the inner housing, they stop moving, and the inner housing receives the movement and moves in the opposite direction relative to the immovable adjusting member. This upward movement of the inner housing also causes the adjusting tool's indicating element to move upward away from the cartridge due to the contact between the inner housing of the handheld device and the indicating element of the adjusting tool.

[0015] Preferably, the indicating element is coupled to a displacement sensor or a portion thereof. Specifically, the displacement sensor can be an optical sensor or an inductive sensor. Alternatively, other types of displacement sensors can also be used. An optical sensor can be, for example, a photoelectric barrier. According to one embodiment, the inductive sensor can be a linear variable differential transformer (LVDT), in which the indicating element is coupled to a movable iron core.

[0016] Furthermore, it is proposed that the indicating element be floatingly mounted in a groove of the positioning member. This floating mounting allows the indicating element to move freely relative to the support member of the positioning member. The groove may, for example, be a through-hole in the support member that at least partially surrounds the indicating element. Preferably, the groove has an inner diameter on at least one front side smaller than the widest outer diameter of the indicating element, so as to secure the indicating element within the groove and prevent it from detaching from the support member. However, depending on the contact between the indicating element and the inner housing member of the handheld device, the indicating element can move relative to the support member, i.e., move within the groove of the positioning member.

[0017] Preferably, the indicating element is biased by the spring force of a spring element that is supported on both the support member and the indicating element. The spring element can be, for example, a helical spring inserted into a cylindrical groove in the positioning member. The restoring force of the spring element moves the indicating element to the front side of the positioning member abutting against the top of the handheld device. Thus, in a fully relaxed state, the indicating element can contact the inner housing of the handheld device. Furthermore, in addition to helical springs, other types of spring elements, such as leaf springs, can also be used.

[0018] According to another possible embodiment, the adjustment tool includes a guide for guiding the movement of the positioning component (particularly relative to the base component). The positioning component can be moved, in particular, by an actuating element of a pneumatic actuator or motor. The guide can be designed in various ways, for example, as one or more pillars on the base component that engage with through holes or bushings of the positioning component. Alternatively, mortise and tenon joints or other methods can be used. The guide guides the movement of the positioning component and adjusts it relative to the handheld device, thereby enabling the adjustment tool (particularly the positioning component of the adjustment tool) to precisely engage with the top of the handheld device housing.

[0019] Furthermore, it is proposed that the positioning component includes an adjustment element that can be inserted into a corresponding slot in the handheld device's adjustment component. The adjustment element can be, for example, an adjustment element like a hexagonal wrench, inserted into a corresponding hexagonal slot in the adjustment component to screw the external threads of the adjustment component into the internal threads of the handheld device's inner housing component. The adjustment element is advantageously inserted into the cavity or recess of an indicating element, which itself is preferably inserted into the cavity or recess of the positioning component of the adjustment tool.

[0020] Preferably, the indicating element has a cylindrical shape, allowing the adjusting element to rotate within the cavity or groove of the indicating element. Since the outer contour of the adjusting element matches or at least corresponds to the shape of the inner contour of the indicating element, the adjusting element can also be precisely positioned relative to the adjustment components of the handheld device.

[0021] Most preferably, the adjusting element, the indicating element, and the positioning part of the adjusting tool can be coaxially aligned. Furthermore, ideal positioning of the adjusting element relative to the groove of the adjusting part can be achieved.

[0022] Furthermore, it is proposed that the adjustment element includes an indicator pin, which is floatingly mounted in a recess within the adjustment element. This indicator pin is specifically associated with a sensor for measuring the position or movement of the indicator pin relative to the recess of the adjustment element. The adjustment element provides support for the indicator pin. The indicator pin is guided within the recess of the adjustment element to move up and down relative to the recess. The indicator pin is specifically used to measure the position or movement of the cartridge within the inner housing of the handheld device.

[0023] When the adjusting element moves toward the handheld device, the indicator pin first inserts into the through hole of the handheld device's adjusting component. This hole is preferably a through hole located in the central portion of the adjusting component's groove. Thus, not only the indicator pin, but the adjusting element itself is also adjusted relative to the handheld device's adjusting component. Depending on the diameter of the hole and the outer diameter of the indicator pin, the adjusting element can be precisely inserted into the groove.

[0024] As the cartridge moves downward due to the adjusting member being screwed into the internal thread of the inner housing, the indicator pin follows the movement of the cartridge under the influence of, for example, gravity acting on it. Alternatively, the restoring force of a spring element can be used to bias the indicator pin. In this way, the function (especially the movement) of the indicator pin is independent of the direction of the adjusting tool relative to gravity. The tip of the indicator pin rests against the top of the cartridge and follows the movement of the cartridge as the adjusting member moves deeper into the inner housing. Thus, it is possible to monitor when the cartridge reaches a defined end position within the handheld device housing.

[0025] The movement or position of the indicator pin can be monitored by sensors such as optical or capacitive sensors. The indicator pin thus provides an additional safety feature and can be used as an add-on function. However, this function is not mandatory for the functionality of the adjustment tool.

[0026] In addition to the adjustment tool, a handheld device arrangement is provided, having a cartridge containing a drug substance. This arrangement is located within an adjustment tool for adjusting the force applied to the cartridge, which is movable between a rest position and a dispensing position, the rest position being blocked by a removable retaining member. The handheld device includes a housing having an outer shell component, an inner shell component, and a mouthpiece for the user to inhale the drug substance. The inner shell component applies a force to the cartridge to move it from the rest position to the dispensing position. The handheld device also includes an adjustment member movable relative to the inner shell component and in contact with the cartridge. The adjustment tool has a positioning component for moving the inner shell component in the adjustment position and an adjustment element for adjusting the position of the adjustment member relative to the inner shell component by moving the adjustment member into contact with the cartridge. The movement of the inner shell component caused by the contact between the adjustment member and the cartridge can be detected to determine the correct position of the adjustment member relative to the inner shell component.

[0027] The arrangement includes an adjustment tool (particularly an adjustment tool according to any of the foregoing embodiments) and a pre-loaded handheld device for dispensing the drug substance in portions, wherein the handheld device includes: a housing having an outer shell component, an inner shell component, and a mouthpiece for the user to inhale the drug substance; and a cartridge containing the drug substance and housed within the housing, wherein the inner shell component is movably disposed within the outer shell component. The cartridge is movably disposed within the inner shell component, and wherein the adjustment component is movably attached to (particularly screwed into) the inner shell component to apply force to the cartridge.

[0028] The adjustment tool provides an indicator element for determining the correct position of the handheld device adjustment component relative to the inner housing component, ensuring optimal functionality of the handheld device regardless of the specific dimensions (especially the height) of the cartridge. Since the indicator element contacts the inner housing component of the handheld device and floats on the support component of the positioning component, it preferably follows the movement of the inner housing component due to gravity and / or the restoring force of the spring element. When the handheld device adjustment component moves into the inner housing component (especially when screwed into the internal threads of the inner housing component), if the cartridge is at its lowest position within the handheld device housing, the adjustment component eventually contacts the top of the cartridge and stops there. As the adjustment component subsequently rotates further, it cannot move further downward due to contact with the cartridge; therefore, the inner housing component moves upward relative to the adjustment component in a direction away from the cartridge, particularly by twisting upward. This movement causes the indicator element to move relative to the support component of the positioning component, as the indicator element abuts against the moving inner housing component of the handheld device.

[0029] Furthermore, a method is proposed for adjusting the position of an adjustment component in a pre-loaded handheld device for dispensing drug substances using an adjustment tool. The handheld device includes: a housing having an outer shell component and an inner shell component movably disposed within the outer shell component; a cartridge containing the drug substance surrounded by the inner shell component; and the adjustment component. The method includes the following steps: mounting the handheld device to a positioning component of the adjustment tool; contacting the outer shell component of the handheld device via a support component of the positioning component; contacting the inner shell component of the handheld device via an indicator element floating on the support component of the positioning component; inserting the adjustment element of the positioning component into a corresponding slot in the adjustment component of the handheld device; moving the adjustment component relative to the inner shell component; and detecting, via a displacement sensor, the movement of the indicator element relative to the support component of the positioning component caused by the movement of the inner shell component of the handheld device relative to the outer shell component of the handheld device.

[0030] First, the pre-assembled handheld device, including the cartridge and adjustment components, is positioned relative to the adjustment tool, preferably between the base component and the positioning component of the adjustment tool. Then, the positioning component is moved toward the handheld device until the indicating element contacts the inner housing component of the handheld device. The support component of the positioning component continues to move downwards until it contacts the outer housing component of the handheld device.

[0031] The movement of the positioning component is preferably caused by an actuating element or a motor (especially a motor). When the support component and the indicating element abut against their respective components of the handheld device, an adjusting element (e.g., a screwdriver) inserts into the slot of the adjusting component and pushes / tightens it (preferably along the internal thread) deeper into the inner housing component. This causes the indicating element to follow the movement of the adjusting component toward the cartridge. The adjusting component eventually contacts the cartridge and stops there. By, for example, further rotating the adjusting component (in its lowest position), the inner housing component receives the movement and twists upward relative to the adjusting component, away from the cartridge. This causes the inner housing component to move toward the positioning component. Consequently, the indicating element also moves relative to the support component of the positioning component. This movement can be detected by a displacement sensor, indicating the position of the adjusting component relative to the inner housing component. Based on the detection signal, the downward movement of the adjusting element can be stopped. Attached Figure Description

[0032] The invention will now be described in more detail with reference to exemplary embodiments. In the accompanying drawings:

[0033] Figure 1 A set of components including adjustment tools and a pre-loaded handheld device for dispensing drug substances in multiple doses;

[0034] Figure 2 : Exploded perspective view of the handheld device (with housing, medicine cartridge and adjustment components);

[0035] Figure 3 :along Figure 1 Cross-sectional view of the adjustment tools and handheld device for Line III;

[0036] Figure 4 Cross-sectional view of the adjustment tools and handheld device during the first assembly step;

[0037] Figure 5 Cross-sectional view of the adjustment tools and handheld device during the second assembly step;

[0038] Figure 6 Cross-sectional view of the adjustment tools and handheld device during the third assembly step;

[0039] Figure 7 Cross-sectional view of the adjustment tools and handheld device during the fourth assembly step;

[0040] Figure 8 Cross-sectional view of the adjustment tools and handheld device during the fifth assembly step;

[0041] Figure 9 Cross-sectional view of the adjustment tools and handheld device during the sixth assembly step;

[0042] Figure 10 Side view of the pre-installed handheld device with the medicine cartridge in its lowest position;

[0043] Figure 11a : The lower part of the handheld device of the inner shell component coupling arm when the pre-filled position of the medicine cartridge is displayed;

[0044] Figure 11b Detailed view of the coupling arm with an elongated hole;

[0045] Figure 12a : The lower part of the handheld device of the inner shell component coupling arm when the reagent cartridge is fully assembled;

[0046] Figure 12b Detailed view of the coupling arm with an elongated hole. Detailed Implementation

[0047] refer to Figure 1 and Figure 2 The arrangement of a handheld device 5 and an adjustment tool 1 for adjusting the position of the adjustment component 2 of the handheld device 5 during assembly is shown and described.

[0048] The handheld device 5 is used to preferably dispense the drug substance in a spray-like manner in multiple applications. The substance contains... Figure 2 The medicine container 11 shown. According to, for example Figure 10 The medicine cartridge 11 has a valve 29, which rests in the valve seat 30 of the handheld device 5 and releases the substance when pressed into the medicine cartridge 11. Typically, the valve is pressed into the medicine cartridge 11 by pressing the opposite side of the cartridge 11. Movement of the medicine cartridge 11 from a rest position to a dispensing position can be achieved by a mechanism (not shown) of the handheld device 5 acting on a stop member 34 of the medicine cartridge 11.

[0049] The substance in cartridge 11 is normally under pressure, so when the valve is pressed into cartridge 11, a portion of the substance is ejected. A predetermined amount of substance is then drawn from cartridge 11 and inhaled by the user of handheld device 5. In order to eject the next portion of substance, cartridge 11 must first be depressurized again, and valve 29 returns to its initial position (the resting position of cartridge 11).

[0050] Pressing the opposite side of the medicine cartridge 11 is initiated, for example, by opening the sealing cap 10 covering the nozzle 9 of the handheld device 5. Pressing the opposite side of the medicine cartridge 11 by opening the sealing cap 10 is caused by the mechanical connection between the cap 10 and the inner shell component 8 of the housing 6 of the handheld device 5. Specifically, as... Figures 10 to 1 As shown in Figure 2, the inner shell component 8 has at least one (preferably two) coupling arm 32, which has an elongated hole 33 into which the eccentric shaft 31 of the closing cover 10 is embedded.

[0051] The housing 6 of the handheld device 5 also has an outer shell component 7. The inner shell component 8 and the outer shell component 7 are preferably cylindrical and coaxially arranged. The inner shell component 8 is movably (i.e., floating and sliding) arranged within the outer shell component 7. The inner shell component 8 comprises—according to Figure 3 An example of this is the internal thread 28 and the internal groove for receiving the medicine cartridge 11.

[0052] The handheld device 5 also includes an adjustment member 2, which is screwed into the thread 28 of the inner housing member 8, for example. Here, the adjustment member 2 has, for example, an external threaded portion 3 that engages with the thread 28 of the inner housing member 8. The adjustment member 2 also has a support portion 4 connected to the threaded portion 3. The support portion 4 is configured to abut against the top side of the medicine cartridge 11 when the handheld device 5 is finally assembled.

[0053] According to an exemplary embodiment of the handheld device 5, the medicine cartridge 11 moves from a rest position to a dispensing position by unscrewing the cap 10 from the nozzle 9. This movement is operated, for example, by a mechanism connecting the cap 10 to the inner shell component 8. The adjustment component 2 of the fully assembled handheld device 5 is controlled by a spring element 26 (see...). Figure 3 The restoring force of the spring element 26 acts on the medicine cylinder 11, and the spring element 26 is located between the threaded portion 3 and the support portion 4 of the adjusting component 2.

[0054] In an exemplary embodiment, and preferably, the coupling arm 32 of the inner shell component 8 can interact with an eccentric shaft 31 formed on the cap 10 of the closed suction nozzle 9. For this purpose, please refer to... Figures 10 to 1 2. The eccentric shaft 31 is preferably housed in an elongated hole 33 on each coupling arm 32.

[0055] When the nozzle cap 10 moves to the open position, the inner shell component 8 is pulled downward toward the valve seat 30, entering the clamped position. As a result, the spring element 26 deforms and is stretched, applying corresponding pressure to the drug cartridge 11.

[0056] The force applied to the medicine cartridge 11 is preferably adjustable. Adjustment can be achieved by changing the effective distance between the adjusting member 2 and the medicine cartridge 11. This is particularly advantageous if the handheld device 5 is equipped with medicine cartridges 11 of different heights. The adjusting member 2 can be adjusted relative to the medicine cartridge 11 using the corresponding threads of the adjusting member 2 and the inner shell member 8, namely the threaded portion 3 of the adjusting member 2 and the thread 28 of the inner shell member 8, as described below.

[0057] Basically, even in the initial position ( Figure 12a and 12b The reagent cartridge 11 may also bear a certain load. However, preferably, the reagent cartridge 11 is not loaded in the initial position.

[0058] The housing 6 is preferably formed as a sleeve, more preferably a cylindrical sleeve. The housing 6 includes an inner housing component 8 and a coaxially aligned outer housing component 7. The inner housing component 8 and the adjusting component 2 are preferably arranged in a nested manner, with the adjusting component 2 located inside the inner housing component 8. The housing 6 can also be designed as two or more parts with respect to the longitudinal extension of the handheld device 5. For example, the lower part may contain a suction nozzle 9 and a valve seat 30, while the upper part supports the adjusting component 2. These two or more parts can snap together.

[0059] During the assembly of the handheld device 5, the housing 6 of the handheld device 5 contains a medicine cartridge 11. Since the medicine cartridge 11 is not typically supplied by the manufacturer of the handheld device 5, the supplied medicine cartridge 11 may have a certain height variation. Furthermore, manufacturing processes and other variables lead to an increase in the height tolerance of the medicine cartridge. This may cause various problems with the performance of the handheld device 5 itself.

[0060] Therefore, the adjustment tool 1 is used to adapt the handheld device 5 to the drug cartridge 11 at different heights during the assembly process.

[0061] according to Figure 1 The exemplary adjustment tool 1 of the embodiment includes a base component 12 and a positioning component 13. However, the base component 12 is not necessarily a mandatory component of the adjustment tool 1 itself. The base component 12 is mounted, for example, at the lower part of the handheld device 5. The positioning component 13 is exemplarily mounted at the top side of the handheld device 5 and provides a mechanism for adjusting the adjustment component 2 of the handheld device 5 relative to the medicine cartridge 11.

[0062] The positioning component 13 can move relative to the base component 12, preferably by means of an actuator (not shown), such as a pneumatic actuator or a motor (especially a motor).

[0063] The positioning component 13 has an indicating element 14. The indicating element 14 is, for example, coaxially mounted in a groove 17 of the support component 27 of the positioning component 13. The groove 17 of the positioning component 13 preferably contains a spring element 15, which acts on a portion of the indicating element 14 and a portion of the support component 27. The indicating element 14 is floatingly mounted within the groove 17 and can slide up and down.

[0064] The positioning component 13 also includes a displacement sensor 16 for detecting the current position of the indicating element 14 relative to the support component 27 of the positioning component 13. The displacement sensor 16 is merely an example here; it could be an optical sensor such as a grating. The function of this displacement sensor 16 will be described later. Alternatively, other types of sensors, such as other optical sensors or different types of sensors, such as inductive sensors, capacitive sensors, or magnetic sensors, could be used.

[0065] The base component 12 of the adjustment tool 1 has, for example, two guides 18 in the form of pillars, which engage with corresponding bushings of the positioning component 13.

[0066] The indicating element 14 of the adjusting tool 1 is preferably also cylindrical and provides an inner cylindrical cavity to specifically support the base component 35 of the adjusting element 19. The adjusting element 19 is, for example, a screwdriver. The base component 35 of the adjusting element 19 also preferably has a corresponding outer cylindrical shape and is coaxially positioned within the internal volume of the indicating element 14.

[0067] According to this embodiment, the adjusting element 19 also has an indicator pin 21. The indicator pin 21 is slidably arranged in the internal volume (groove 22) of the adjusting element 19 (particularly the base component 35 of the adjusting element 19). The indicator pin 21 is configured to rest on the top side of the medicine cartridge 11 of the handheld device 5 when the positioning component 13 contacts the handheld device 5. The functional aspects of the indicator pin 21 will be described later.

[0068] Actuating element 23 (e.g., a component of a motor) can be as follows: Figure 1 It is coupled to the adjustment element 19 as shown.

[0069] Figure 2 An exploded view of the components of the pre-installed handheld device 5 is shown, namely the housing assembly, the medicine cartridge 11, and the adjustment component 2. The housing assembly here includes, for example, an outer shell component 7, an inner shell component 8, a nozzle 9, and a cap 10. The adjustment component 2 has a threaded portion 3 and a support portion 4. The support portion 4 is configured in the final adjustment position ( Figure 12a and 12b ) Contact the top surface of the reagent cartridge 11.

[0070] The support portion 4 is biased against the threaded portion 3 by the spring element 26. The spring element 26 is supported on the lower surface of the threaded portion 3 on one hand, and on the inner surface of the front side of the support portion 4 on the other hand. The support portion 4 is, for example, cup-shaped and accommodates a portion of the threaded portion 3 biased by the spring element 26. Therefore, the spring element 26 is surrounded at least circumferentially by the cup-shaped support portion 4.

[0071] The threaded portion 3 of the adjusting component 2 has a central groove 20, here in the form of a hexagonal groove 20, for use with hexagonal tools. However, the groove 20 can be formed in other forms to correspond to the corresponding adjusting element 19. The groove 20 is formed as a through hole 24, the diameter of its upper part (groove 20) being larger than the lower part facing the support portion 4 and the reagent cartridge 11.

[0072] The support portion 4 of the adjusting component 2 also has, for example, a corresponding guide 25 for inserting an indicator pin 21 that is floatingly mounted in the groove 22 of the adjusting element 19. The guide 25 is also formed as a through hole and is arranged coaxially with respect to the groove 20 and the through hole 24.

[0073] The adjustment of the adjustment component 2 inside the housing 6 of the handheld device 5 using the adjustment tool 1 is now described in more detail.

[0074] First, the pre-installed handheld device 5 is installed into the base component 12 of the adjustment tool 1. At this stage, the handheld device 5 includes a housing 6, a medicine cartridge 11, and an adjustment component 2. The adjustment component 2 may have been pre-screwed slightly into the corresponding internal thread 28 of the inner housing component 8 of the handheld device 5. However, the adjustment component 2 has not yet been adjusted according to the specific height of the medicine cartridge 11.

[0075] In order to mount the handheld device 5 onto the adjustment tool 1, the base component 12 of the adjustment tool 1 preferably includes a groove 17, the shape of which corresponds to the outer contour of the housing 6 of the handheld device 5 (including, for example, the nozzle 9 and its cover 10).

[0076] Then, the positioning component 13 of the adjustment tool 1 moves toward the base component 12. This can be done manually by the user of the adjustment tool 1 or automatically by the actuating element 23 (e.g., using an actuator, such as a motor). This movement is guided by the guide 18 connecting the base component 12 and the positioning component 13.

[0077] according to Figure 4 In the exemplary embodiment shown, firstly, the indicator element 14 of the adjustment tool 1 contacts the inner shell component 8 of the handheld device 5. Since the indicator element 14 is floatingly mounted in the support component 27 of the positioning component 13, it moves under the action of gravity and the spring element 15 of the positioning component 13. Figure 1 and Figure 3The lowest position shown (relative to support member 27) is until, for example, a mechanical force from an actuator or motor acts on the support member 27 of the positioning member 13, moving the support member 27 toward the base member 12, as... Figure 5 As shown. In its lowest position, the indicator element 14 protrudes slightly from the adjacent area of ​​the support member 27.

[0078] As the positioning component 13 moves further downward toward the base component 12, the support component 27 also begins to contact the housing 6 (i.e., the outer shell component 7) of the handheld device 5 (e.g., ...). Figure 5 (As shown). When the support member 27 moves downward, the indicating element 14 remains in the same position as before (relative to the inner shell member 8) due to its floating mounting. The indicating element 14 remains in contact with the inner shell member 8. Under the restoring force of the spring element 15 and / or its weight, the indicating element 14 pushes the inner shell member 8 into the outer shell member 7.

[0079] exist Figure 5 As shown, the displacement sensor 16 can measure the position of the indicating element 14 relative to the positioning member 13 and the support member 27. This position here corresponds, for example, to... Figure 5 The distance “a” between the indicating element 14 and the support member 27 is shown. This position will be defined as the zero point and will serve as the reference for all subsequent measurements by the displacement sensor 16. However, the reference measurement is not required, as will be clear below. It is merely an optional feature.

[0080] As a non-mandatory feature, the indicator pin 21 is optionally used to indicate the movement of the cartridge 11 relative to the housing 3. Thus, the adjustment element 19 is moved manually or by an actuator or motor toward the handheld device 5 until the tip of the indicator pin 21 touches the top surface of the cartridge 11. The indicator pin 21 is therefore slidably mounted in the groove 22 of the adjustment element 19. The indicator pin 21 moves buoyantly within the adjustment element 19 under the influence of gravity. The position of the indicator pin 21 relative to the base component 35 of the adjustment element 19 can be measured by a sensor (e.g., an optical or electromagnetic sensor (not shown)). According to one embodiment, the sensor can be an inductive sensor, such as an LVDT (Linear Variable Differential Transformer).

[0081] After positioning the tip of adjusting element 19 into slot 20 (both are hexagonal), adjusting element 19 begins to rotate, either manually or automatically. Figure 7 The adjusting component 2 of the handheld device 5 is rotated clockwise, for example, and further into the internal thread 28 of the inner shell component 8, until the support portion 4 of the adjusting component 2 contacts the medicine cartridge 11. Figure 8 ).

[0082] Since the adjusting component 2 cannot be screwed further into the medicine cartridge 11, and the coupling arm 32 of the inner shell component 7 is in a position as Figure 11a and 11b The lowest position is shown, therefore the direction of rotation is reversed, for example, counterclockwise. This means that the inner housing component 8 is rotated upward relative to the now stationary adjusting component 2 until the coupling arm 32 of the inner housing component 8 reaches the lowest position shown. Figure 12a and 12b The position shown. The upward movement of the inner shell component 8 is possible because the inner shell component 8 is floatingly mounted within the outer shell component 7 of the handheld device 5.

[0083] After the upward movement of the inner shell component 8 is detected, continuing to rotate the adjusting component 2 clockwise will compress the medicine cartridge 11. To prevent the adjusting component 2 from being overtightened and damaging the medicine cartridge 11, an indicator pin 21 is used to indicate the movement of the medicine cartridge 11. The indicator pin 21 is preferably connected to a displacement sensor (not shown), such as an LVDT. If the sensor detects the movement of the medicine cartridge 11, counterclockwise rotation of the adjusting component 2 can be initiated to avoid applying a load to the medicine cartridge 11.

[0084] The inner housing component 8 can, for example, move upward toward the positioning component 13 by a fraction of a millimeter or up to one millimeter or more, depending on the dimensions of the elongated bore 33 and the eccentric shaft 31. Here, for example, a movement distance of 0.5 millimeters can be achieved.

[0085] Figure 9 A distance a' is displayed, which relates to the distance traveled compared to the initial distance a between the indicating element 14 and the support member 27. The difference between distance a' and distance a can be measured by the displacement sensor 16 as an indication of the current position of the adjusting member 2 relative to the inner shell member 8, that is, indicating the perfect positioning of the adjusting member 2 relative to a specific height of this medicine cartridge 11.

[0086] However, comparing distances a' and a is not necessary, because the upward movement of the inner shell component 8 itself, combined with the potential reach of the inner shell component 8, is as follows: Figure 12a and 12b The highest position shown is the indication of the correct position of the adjusting component 2. Once the displacement sensor 16 detects the upward movement of the indicating element 14, the perfect position of the adjusting component 2 relative to the medicine cartridge 11 can be assumed, and the movement of the adjusting element 19 can be stopped.

[0087] Here, displacement sensor 16 is an optical sensor. However, other sensors, such as inductive sensors like LVDTs, can also be used.

[0088] An optional evaluation device connected to the displacement sensor 16 can evaluate the movement of the indicating element 14, thereby evaluating the optimal position of the adjusting component 2 relative to the reagent cartridge 11.

[0089] Then, the positioning part 13 of the adjustment tool 1 is finally lifted relative to the base part 12, and the assembled handheld device 5 can be removed from the adjustment tool 1.

[0090] The foregoing statements are used to explain the overall solutions covered by this application, each of which independently advances the prior art through the following combinations of features, wherein two, more, or all of these combinations of features may also be combined, specifically:

[0091] An adjustment tool, characterized in that the adjustment tool 1 includes a positioning member 13 for clamping at least a portion of the handheld device 1 and applying force to an adjustment member 2 of the handheld device 1, wherein the positioning member 13 includes an indicator element 14 movably arranged on a support member 27 of the positioning member 13 to indicate the current position of the adjustment member 2 relative to the medicine cartridge 11.

[0092] An adjustment tool, characterized in that the indicating element 14 abuts against the inner shell component 8 so as to indicate the current position of the adjustment component 2 by means of movement of the inner shell component 8 relative to the adjustment component 2.

[0093] An adjustment tool, characterized in that the indicating element 14 is coupled to or is part of a displacement sensor 16, particularly an optical sensor or an inductive sensor.

[0094] An adjustment tool, characterized in that the indicating element 14 is floatingly mounted in the groove 17 of the positioning member 13.

[0095] An adjustment tool is characterized in that the indicating element 14 is biased by the spring force of a spring element 15, which is supported on the support member 27 on one side and on the indicating element 14 on the other side.

[0096] An adjustment tool, characterized in that the adjustment tool 1 includes a guide 18 for guiding the positioning member 13 to move relative to a base member 12, wherein the positioning member 13 is particularly moved by an actuating element 23 of a pneumatic actuator or motor.

[0097] An adjustment tool, characterized in that the positioning component 13 includes an adjustment element 19, which can be inserted into a corresponding slot 20 of the adjustment component 2 of the handheld device 5.

[0098] An adjustment tool is characterized in that the adjustment element 19 includes an indicator pin 21, which is floatingly mounted in a groove 22 of the adjustment element 19, wherein the indicator pin 21 is specifically associated with a sensor for measuring the position or movement of the indicator pin 21 relative to the groove 22 of the adjustment element 19.

[0099] A handheld device 5 is arranged in an adjustment tool 1. The handheld device 5 has a cartridge 11 containing a drug substance for adjusting the force applied to the cartridge 11. The cartridge 11 is movable between a rest position and a dispensing position, the rest position being blocked by a removable retaining member. The handheld device 5 includes a housing 6 having an outer shell member 7, an inner shell member 8, and a mouthpiece 9 for the user to inhale the drug substance. The inner shell member 8 applies a force to the cartridge 11 to move the cartridge 11 from the rest position to the dispensing position. The handheld device 5 also includes an adjustment member 2 movable relative to the inner shell member 8 and in contact with the cartridge 11. The adjustment tool 1 has a positioning member 13 for moving the inner shell member 8 in the adjustment position and an adjustment element 19 for adjusting the position of the adjustment member 2 relative to the inner shell member 8 by moving the adjustment member 2 into contact with the cartridge 11. The movement of the inner shell member 8 caused by the contact between the adjustment member 2 and the cartridge 11 can be detected to determine the correct position of the adjustment member 2 relative to the inner shell member 8.

[0100] A method for adjusting the position of an adjusting member 2 in a pre-loaded handheld device 5 for dispensing drug substances in multiple doses using an adjusting tool 1, characterized in that the handheld device 5 comprises: a housing 6 having an outer shell component 7 and an inner shell component 8 movably arranged within the outer shell component 7; a drug cartridge 11 containing the drug substance surrounded by the inner shell component 8; and the adjusting member 2. The method includes the following steps: mounting the handheld device 5 to a positioning component 13 of the adjusting tool 1; contacting the outer shell component 7 of the handheld device 5 via a support component 27 of the positioning component 13; contacting the inner shell component 8 of the handheld device via an indicator element 14 floatingly mounted on the support component 27 of the positioning component 13; inserting an adjusting element 19 of the positioning component 13 into a corresponding slot 2 of the adjusting member 2 of the handheld device 5; moving the adjusting member 2 relative to the inner shell component 8; and detecting, by a displacement sensor 16, the movement of the indicator element 14 relative to the support component 27 of the positioning component 13 caused by the movement of the inner shell component 8 of the handheld device 5 relative to the outer shell component 7 of the handheld device 5.

[0101] A method characterized in that the adjusting member 2 moves toward the medicine cylinder 11 until the adjusting member 2 contacts the medicine cylinder 11, wherein after contact, the inner shell member 8 automatically moves away from the medicine cylinder 11.

[0102] List of reference numerals

[0103] 1. Adjustment tools

[0104] 2 Adjustment components

[0105] 3. Threaded portion

[0106] 4. Supporting components

[0107] 5. Handheld devices

[0108] 6. Shell

[0109] 7. Housing components

[0110] 8. Inner shell components

[0111] 9. Suction nozzle

[0112] 10 lids

[0113] 11. Medicine container

[0114] 12 Basic Components

[0115] 13 Positioning components

[0116] 14 Indicating elements

[0117] 15 Spring elements

[0118] 16 Displacement Sensors

[0119] 17 Grooves

[0120] 18 Guide components

[0121] 19 Adjustment elements

[0122] 20 slots

[0123] 21 Indicator Pin

[0124] 22 Grooves

[0125] 23 Actuating elements

[0126] 24 through holes

[0127] 25 Guide components

[0128] 26 Spring elements

[0129] 27 Support components

[0130] 28 thread

[0131] 29 valves

[0132] 30 Valve seat

[0133] 31 Eccentric Shaft

[0134] 32 coupling arms

[0135] 33. Oblong hole

[0136] 34 Stopping components

[0137] 35 Basic Components

[0138] a distance

[0139] a' distance

Claims

1. An adjustment tool (1) for adjusting the position of the adjustment component (2) during the process of installing the adjustment component (2) into a pre-loaded handheld device (5) for dispensing drug substances in portions, wherein the handheld device (5) comprises: A housing (6) having an outer shell component (7), an inner shell component (8), and a mouthpiece (9) for a user to inhale a drug substance; and a cartridge (11) contained in the housing (6) and containing the drug substance, wherein the inner shell component (8) is movably disposed within the outer shell component (7), wherein the cartridge (11) is movably disposed within the inner shell component (8), and wherein the adjusting component (2) is movably attached to the inner shell component (8) to apply force to the cartridge (11), wherein the adjusting tool (1) includes a positioning component (13) for clamping at least a portion of the handheld device (1) and applying force to the adjusting component (2) of the handheld device (1), wherein the positioning component (13) includes an indicating element (14) movably disposed on a support component (27) of the positioning component (13) to indicate the current position of the adjusting component (2) relative to the cartridge (11).

2. The adjustment tool (1) according to claim 1, wherein, The indicating element (14) abuts against the inner shell component (8) so as to indicate the current position of the adjusting component (2) by the movement of the inner shell component (8) relative to the adjusting component (2).

3. The adjustment tool (1) according to claim 1 or 2, wherein, The indicating element (14) is coupled to the displacement sensor (16) or a part of the displacement sensor (16), particularly an optical sensor or an inductive sensor.

4. The adjustment tool (1) according to any one of the preceding claims, wherein, The indicator element (14) is floatingly mounted in the groove (17) of the positioning component (13).

5. The adjustment tool (1) according to any one of the preceding claims, wherein, The indicating element (14) is biased by the spring force of the spring element (15), which is supported on the support member (27) on one side and on the indicating element (14) on the other side.

6. The adjustment tool (1) according to any one of the preceding claims, wherein, The adjustment tool (1) includes a guide (18) for guiding the positioning component (13) to move relative to the base component (12), wherein the positioning component (13) is moved in particular by an actuating element (23) of a pneumatic actuator or motor.

7. The adjustment tool (1) according to any one of the preceding claims, wherein, The positioning component (13) includes an adjustment element (19) that can be inserted into a corresponding slot (20) of the adjustment component (2) of the handheld device (5).

8. The adjustment tool (1) according to claim 7, wherein, The adjustment element (19) includes an indicator pin (21) that is floatingly mounted in a groove (22) of the adjustment element (19), wherein the indicator pin (21) is specifically associated with a sensor for measuring the position or movement of the indicator pin (21) relative to the groove (22) of the adjustment element (19).

9. The arrangement of the handheld device (5) in the adjustment tool (1) for adjusting the force applied to the drug cartridge (11), the drug cartridge (11) containing a drug substance, the drug cartridge (11) being movable between a rest position and a dispensing position, the rest position being blocked by a removable retaining member, the handheld device (5) including a housing (6) having an outer shell member (7), an inner shell member (8) and a mouthpiece (9) for the user to inhale the drug substance, the inner shell member (8) applying force to the drug cartridge (11) to move the drug cartridge (11) from the rest position to the dispensing position, the handheld device (5) also including The adjustment tool (1) includes an adjustment member (2) movable relative to the inner shell component (8) and in contact with the medicine cartridge (11). The adjustment tool (1) has a positioning member (13) for moving the inner shell component (8) in an adjustment position and an adjustment element (19) for adjusting the position of the adjustment member (2) relative to the inner shell component (8) by moving the adjustment member (2) into contact with the medicine cartridge (11). The movement of the inner shell component (8) caused by the contact between the adjustment member (2) and the medicine cartridge (11) can be detected to determine the correct position of the adjustment member (2) relative to the inner shell component (8).

10. A method for adjusting the position of an adjusting component (2) in a pre-loaded handheld device (5) for dispensing drug substances in multiple doses by means of an adjusting tool (1), wherein the handheld device (5) comprises: A housing (6) having an outer shell component (7) and an inner shell component (8) movably arranged within the outer shell component (7); The method comprises the following steps: a pharmaceutical cartridge (11) containing the pharmaceutical substance, surrounded by the inner shell component (8); and the adjusting component (2). The handheld device (5) is mounted onto the positioning component (13) of the adjustment tool (1); The supporting member (27) of the positioning member (13) contacts the outer shell member (7) of the handheld device; The inner shell component (8) of the handheld device is contacted by an indicator element (14) floating on the support component (27) of the positioning component (13); Insert the adjusting element (19) of the positioning component (13) into the corresponding slot (2) of the adjusting component (2) of the handheld device (5); The adjusting member (2) is moved relative to the inner shell member (8); The displacement sensor (16) detects the movement of the indicator element (14) relative to the support member (27) of the positioning member (13) caused by the movement of the inner shell member (8) of the handheld device (5) relative to the outer shell member (7) of the handheld device (5).

11. The method according to claim 10, wherein, The adjusting component (2) moves toward the medicine cylinder (11) until the adjusting component (2) contacts the medicine cylinder (11), wherein after contact, the inner shell component (8) automatically moves away from the medicine cylinder (11).

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