Method for assembling a dispensing device and dispensing device

Abstract

A method for assembling a dispensing device for dispensing a drug is proposed, for which a sealing element is fixed in a receiving space of the dispensing device using specific assembly parameters. A plurality of sealing elements are preferably produced in a batch, and all sealing elements of the batch are fixed using the same assembly parameters. Furthermore, a dispensing device for dispensing a drug is proposed.

Description

Technical Field

[0001] The present invention relates to a method of assembling a dispensing device for dispensing a drug according to the preamble of claim 1, and a dispensing device for dispensing a drug according to the preamble of claim 19.

[0002] In particular, the present invention relates to the arrangement or assembly of a sealing element within a receiving space of a dispensing device assigned to the sealing element. Preferably, the sealing element is used to seal a conveying element used to convey a drug from a container of the dispensing device. For this purpose, within a fully assembled dispensing device, the sealing element is in sealing contact with the conveying element. Preferably, the conveying element is movable relative to the sealing element. In particular, the conveying element is moved relative to the sealing element to convey the drug.

Background Art

[0003] When using a sealing element to seal a conveying element, various requirements must be met. On the one hand, a reliable seal must be ensured even when the dispensing device is stored over a long period or has a long service life. In other words, a permanent and reliable "static seal" of the conveying element must be achieved by the sealing element. On the other hand, when the dispensing device is in use, a reliable seal must be ensured, especially when the conveying element moves relative to the sealing element. That is, a so-called "dynamic seal" must be achieved.

[0004] Desirable seals in both the static case where the sealing element is stationary relative to the conveying element and the dynamic case where the conveying element is moved relative to the sealing element can impose different and conflicting requirements. In particular, good static sealing can be achieved by having the sealing element stationary relative to the conveying element over as large an area as possible and / or as rigidly as possible. However, this is disadvantageous for dynamic sealing because when the conveying element is moved relative to the sealing element, firm contact of the sealing element over a large area of the conveying element can lead to increased wear or damage to the sealing element and increased force consumption, or can lead to slow movement of the conveying element.

[0005] Furthermore, for good static sealing, the sealing of the conveying element by the sealing element should be as anti-diffusive as possible. Accordingly, diffusion through the sealing element should be prevented or at least minimized.

[0006] WO 2004 / 053362 A1 relates to a piston pump system having a piston guided within a guide tube and capable of performing a lifting movement along a longitudinal axis, with an O-ring seal held in a groove provided in the guide tube to seal the piston. It has been recognized that good sealing can be achieved when the filling degree of the seal in the groove is optimally adjusted. The "filling degree" corresponds to the ratio of the volume of the (undeformed) seal to the volume of the groove. It has been proposed to use a filling degree higher than 90%, i.e., to use a sufficiently voluminous sealing ring.

[0007] A method by which a reliable seal of the conveying element of the dispensing device is to be achieved is known, for example, from WO 2007 / 051536 A1 or US 2007 / 0282276 A1. It is recognized that the sealing elements are subject to certain manufacturing tolerances, as a result of which the sizes of the sealing elements of different batches are different, and for this reason a reliable seal becomes a problem. To eliminate this problem, the size of the sealing element corresponding to the volume in particular is determined for each batch of the sealing elements. Each batch of the sealing elements is assigned to a specific group of components of the dispensing device, and each of the components forms a groove-shaped receiving space for the sealing element, and the different groups of components have different sizes of the receiving space. Next, each batch of the sealing elements is combined with a specific group of components of the dispensing device so that a desired filling degree and thus a good seal by the sealing element are achieved.

[0008] In the above method, there are increasing storage requirements for storing different batches of the sealing elements and different groups of components. In addition to this, this method cannot be used flexibly for different sealing materials.

Prior Art Documents

Patent Documents

[0009]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Summary of the Invention

Problems to be Solved by the Invention

[0010] It is an object of the present invention to provide a simple and flexible solution for reliably and permanently sealing the transport elements of a dispensing device for dispensing drugs.

Means for Solving the Problems

[0011] The above object is achieved by the method according to claim 1 or the dispensing device according to claim 19. Advantageous refinements are the subject matter of the dependent claims.

[0012] According to the present proposal, the sealing element is installed in the dispensing chamber of the dispensing device using predetermined assembly parameters.

[0013] The assembly parameters can be determined individually for each sealing element or randomly for a batch of sealing elements.

[0014] The assembly parameters can be determined either in the receiving space of the dispensing device or, especially in the case of random determination, in a test system. For this purpose, preferably, the test system has a receiving space having the same dimensions as the receiving space of the dispensing device, in particular.

[0015] In particular, the present invention relates to a method for assembling a dispensing device for dispensing drugs and a dispensing device for dispensing drugs, and a sealing element having specific assembly parameters is arranged and fixed in the receiving space of the dispensing device.

[0016] The sealing element arranged in the receiving space of the dispensing device or the test system is preferably deformed, and the assembly parameters are determined in this step based on the deformation behavior and / or frictional behavior of the sealing element during deformation.

[0017] After the assembly parameters are determined, the sealing element or yet another sealing element to be installed is fixed in the receiving space of the dispensing device using the assembly parameters.

[0018] The assembled or sealed element-fixed dispensing device can be the same dispensing device with the sealing element disposed therein or in its receiving space to determine the assembly parameters. However, it is also possible that the assembled or sealed element-fixed dispensing device is a different dispensing device or a different replica of the same dispensing device from the dispensing device or receiving space used to determine the assembly parameters, or has a different replica of the same receiving space. This is especially the case for the batch method described in more detail below.

[0019] By determining and / or using the assembly parameters based on the deformation behavior and / or frictional behavior, the manufacturing tolerances of the sealing element, as well as differences in size and / or material, can be taken into account or compensated for in a simple manner, and a reliable seal and / or sealing effect can be guaranteed. This contributes to the consistent quality in the manufacture or assembly of a plurality of dispensing devices, especially in an automated process.

[0020] Preferably, the assembly parameters are adjustable and particularly geometric values that must be observed when the dispensing device is assembled and / or are implemented on the fully assembled dispensing device. Preferably, the assembly parameters are variably pre-specified in the configuration of the assembly process. Preferably, the assembly parameters are, for example, geometric parameters of the components, particularly preferably dimensions such as relative positions or the height of the receiving space of the dispensing device. In particular, the assembly parameter is the position of the fixing element relative to the guiding element, and the sealing element is fixed within the guiding element or in its receiving space using the fixing element.

[0021] A plurality of sealing elements are preferably provided in batches. Preferably, the assembly parameters for each batch are determined separately using a random sample of this batch. These assembly parameters determined for the batch are preferably used each time the sealing elements of the batch are fixed in the receiving space.

[0022] Preferably, the assembly parameters for a batch are preferably determined separately or independently of the assembly of the sealing element or dispensing device, in particular separately with respect to time and / or space, in a system different from the assembly of the sealing element or dispensing device. In other words, the determination of the assembly parameters and the assembly of the dispensing device are preferably carried out separately from each other. Below, this method is also particularly referred to as the "batch method".

[0023] Preferably, the assembly parameters are each selected such that the same deformation value of the sealing element is brought about in the receiving space for different batches or independently of the batch with a fully assembled dispensing device. The deformation value is, in particular, a measure of how much the sealing element is deformed, in particular compressed. As a result, the manufacturing tolerances of the sealing element, as well as differences in size and / or material, can be taken into account or compensated for in a simple manner, and a reliable seal and / or sealing effect can be ensured. This contributes to a consistent quality in the manufacture or assembly of a plurality of dispensing devices, particularly in an automated process.

[0024] During assembly, preferably, the deformation value is adjusted by the position, in particular the axial position, of the fixing element and / or contact element used to deform the sealing element. In particular, in this case, a specific deformation value of the sealing element is implemented using the assembly parameters.

[0025] To determine the assembly parameters of a batch, preferably, first the assembly parameters for each sealing element in a random sample are determined separately, and the average value of these assembly parameters determined for the separate or individual sealing elements is defined as the assembly parameters for all the sealing elements of this batch. In other words, preferably, the assembly parameters determined for a batch are an average value from a plurality of assembly parameters. As a result, the manufacturing tolerances of the sealing element, as well as differences in size and / or material, can be taken into account or compensated for in a simple manner, and a reliable seal and / or sealing effect can be ensured. This contributes to a consistent quality in the manufacture or assembly of a plurality of dispensing devices, particularly in an automated process.

[0026] During the determination of the assembly parameters, preferably, the central element is passed through the opening of the sealing element, and the volume of the receiving space is reduced or limited by the central element. This contributes to easy assembly and consistent quality, particularly in the manufacture or assembly of multiple dispensing devices in an automated process.

[0027] Preferably, the central element is removed from the receiving space and / or the opening of the sealing element after the sealing element has been fixed in place. The use of the central element offers the advantage that the deformation of the sealing element during the determination of the assembly parameters corresponds to the deformation that the sealing element has when the dispensing device is fully assembled, and there is no need to assemble the conveying element when determining the assembly parameters. Thus, the use of the central element contributes to an easy and reliable determination of the assembly parameters and / or contributes to ensuring a reliable seal and / or sealing effect. Furthermore, the use of the central element enables the determination of the assembly parameters independently of the assembly of the sealing element or before the assembly of the sealing element and / or in a system different from the assembly of the sealing element. This contributes to an optimal process, particularly in the determination of the assembly parameters in an automated process and / or during the assembly of the sealing element.

[0028] Preferably, the diameter of the central element corresponds to the diameter of the conveying element of the dispensing device that is designed to convey a drug, in particular from the container of the dispensing device, and / or is assigned to or connected to the discharge device of the dispensing device for generating an aerosol. This contributes to a reliable seal and / or sealing effect.

[0029] The number of sealing elements in the random sample is preferably less than 50‰, preferably less than 20‰, particularly less than 10‰, particularly preferably less than 5‰, and very preferably less than 2‰ of the number of sealing elements in the batch. This enables a minimal level of difficulty in the determination of the assembly parameters and an efficient determination of the assembly parameters.

[0030] Alternatively or in addition thereto, preferably, the deviation of the volume of the batch sealing element from the target volume or average volume of the batch sealing element is less than 10%, preferably less than 5%, and particularly preferably less than 4%. This contributes to consistent quality in the manufacture or assembly of a plurality of dispensing devices, particularly in an automated process.

[0031] The above-described features relate in particular to a method, also referred to below as the "batch method", in which the sealing elements are manufactured or available in batches, and in which the assembly parameters for each batch are first determined based on a random sample and are subsequently used for the installation of each sealing element of the batch.

[0032] However, first, the assembly parameters for the sealing element can be determined each time the sealing element is installed, and then the sealing element can be fixed in the receiving space using the assembly parameters determined, particularly immediately after the assembly parameters are determined. In particular, this determination and fixing is independent of whether the sealing elements are provided or manufactured in batches and / or whether the individual sealing elements differ significantly from each other. Thus, a method, described below and also referred to as the "individual method" in another explanation, is particularly advantageous when the individual sealing elements differ significantly from each other, but can be carried out for all sealing elements, particularly for those that are very similar within a batch.

[0033] As described above, in the individual method in which the sealing element arranged in the receiving space is preferably also deformed and the assembly parameters are determined during this deformation, the sealing element is deformed by the fixing element and / or the contact element acting on the sealing element, and is fixed in the receiving space immediately after the assembly parameters are determined. As a result, the manufacturing tolerances of the sealing element, as well as differences in size and / or material, can be taken into account or compensated in a simple manner, and a reliable seal and / or sealing effect can be ensured. This contributes to consistent quality in the manufacture or assembly of a plurality of dispensing devices, particularly in an automated process.

[0034] In an individual method of fixing a sealing element in a receiving space immediately after deforming the sealing element to determine assembly parameters, preferably, the assembly parameters are determined separately for each sealing element to be installed and are used only when fixing the sealing element for which the assembly parameters have been determined in each case. This is advantageous for ensuring a reliable seal and / or sealing effect in the case of sealing elements that are significantly different from each other.

[0035] Preferably, the embodiments described in more detail below apply to both a method (batch method) of first determining the assembly parameters for all the sealing elements of a batch using a random sample and performing the assembly (using the assembly parameters) separately from the determination of the assembly parameters, and a method (individual method) of determining the assembly parameters separately for each sealing element and fixing the sealing element in the receiving space using these assembly parameters immediately after the determination of the assembly parameters.

[0036] It is preferable that the assembly parameters represent or correspond to the position, in particular the axial position, of a fixing element and / or a contact element relative to a guiding element of a dispensing device, or that the (relative) position of the fixing element and / or the contact element is defined or specified by the assembly parameters. In this case, the guiding element preferably at least partially comprises or forms the receiving space. Furthermore, the receiving space is preferably delimited by the fixing element and / or the contact element.

[0037] Preferably, the fixing element and / or the contacting element is / are designed to fix the sealing element in the receiving space and / or fix the sealing element in the receiving space. Particularly preferably, the contacting element is or can be arranged between the sealing element and the fixing element and directly contacts the sealing element to fix it in the receiving space. Preferably, the contacting element is or can be fixed using the fixing element. Thus, in particular, the contacting element is directly fixed using the fixing element, and thus the sealing element is indirectly fixed in the receiving space. Alternatively, the contacting element can be designed as a single part together with the fixing element. As a result, the manufacturing tolerances of the sealing element, as well as differences in size and / or material, can be taken into account or compensated in a simple manner, and a reliable seal and / or sealing effect can be ensured. This contributes to consistent quality in the manufacture or assembly of a plurality of dispensing devices, particularly in an automated process.

[0038] Preferably, the different assembly parameters correspond to different volumes of the receiving space or a variable difference between the volume of the sealing element and the volume of the receiving space. Thus, the volume of the receiving space can be adjusted or changed by the assembly parameters so as to compensate for the manufacturing tolerances of the sealing element and / or the receiving space, as well as differences in size and / or material. This contributes to a reliable seal and / or sealing effect and consistent quality in the manufacture of a plurality of dispensing devices, particularly in an automated process.

[0039] Preferably, the assembly parameters are selected or determined such that when the sealing element is fixed, the deformation value corresponding to the deformation of the sealing element reaches or exceeds a threshold value. Preferably, for example, different threshold values are provided for sealing elements with different outer shapes and / or materials used. The threshold value is preferably pre-specified or can be so. In this way, a reliable seal and / or sealing effect, and thus consistent quality, can be achieved in a simple manner in the manufacture of a plurality of dispensing devices. Furthermore, the method can be adapted to different sealing elements and thus can be used flexibly.

[0040] Preferably, the deformation value is a measure of how much the sealing element is deformed. When the sealing element is deformed, especially within a ring-shaped receiving space, for example, by a plunger, preferably, elastic deformation of the sealing element occurs first. During this deformation, preferably, the volume of the sealing element remains at least approximately constant, and at least substantially only the outer shape of the sealing element changes. Due to this deformation of the sealing element, the shape of the sealing element adapts to the shape of the receiving space and gradually fills it. This adaptation and filling continue until the sealing element fills the receiving space at least approximately completely and / or until the shape of the sealing element at least approximately corresponds to the shape of the receiving space.

[0041] Next, when the sealing element is further deformed, compressed, or pressed within the receiving space, preferably, volumetric compression of the sealing element occurs. In contrast to (elastic) deformation, volumetric compression reduces the volume of the sealing element.

[0042] In summary, the behavior of the sealing element during deformation within the receiving space can be at least approximately divided into two phases. In the first phase, deformation occurs with a substantially constant volume, while in the second phase, volumetric compression occurs.

[0043] Of course, it cannot be ignored that near the end of the first phase and / or during deformation, (small) volumetric compression will already occur.

[0044] The above-mentioned threshold value and / or the threshold value for the deformation value, that is, the threshold value used to determine and / or select the assembly parameter, preferably corresponds to the start of volumetric compression of the sealing element. In other words, this threshold value is preferably the value of the deformation value when the volumetric compression of the sealing element begins. In this way, a reliable seal and / or sealing effect can be ensured. Furthermore, excessive wear or abrasion is prevented. This contributes to consistent quality in the manufacture or assembly of a plurality of dispensing devices, especially in an automated process.

[0045] Particularly preferably, the sealing element is deformed by the movement of a plunger and / or a contact element or a fixing element relative thereto. The plunger acts on the contact element and / or the fixing element, thereby indirectly moving the contact element and / or the fixing element relative to the sealing element, and thus deforming the sealing element by the contact element and / or the fixing element. However, it is also possible for the plunger to act directly on the sealing element and / or to deform the sealing element.

[0046] Preferably, the movement of the plunger and / or the contact element or the fixing element relative to the sealing element occurs in the axial direction and / or the radial direction. In particular, the sealing element is arranged in the receiving space such that the force or pressure acting on the sealing element using the plunger and / or the contact element or the fixing element achieves the deformation and / or compression of the sealing element within the receiving space.

[0047] To determine or examine the deformation behavior of each of the sealing elements, the force required for deformation in each case is determined (directly or indirectly), and in particular measured, for different deformations or deformation values of the sealing element. In this way, the force required for a specific deformation value can be determined. The force required for deformation, which is determined or measured, in particular constitutes an eigenvalue from which the deformation value can be determined, calculated, or derived or vice versa. Instead of this, the force to achieve the deformation can be specified, and the deformation and / or the movement path or the axial position of the corresponding plunger and / or contact element or fixing element or in particular the height of the receiving space can be determined, in particular measured.

[0048] Instead of or in addition to determining or examining the deformation behavior of the sealing element, as described above, the frictional behavior of the sealing element can be determined and / or scrutinized. To determine and / or scrutinize the frictional behavior of each of the sealing elements, preferably, the boundary between the sealing element and the receiving space is moved relative to each other, and the frictional force between the sealing element and the boundary is determined, in particular measured, for different deformations or deformation values of the sealing element in each case. Preferably, the force measurement value constitutes an eigenvalue from which the deformation value can be determined, calculated, or derived or can do so. The boundary of the receiving space that is moved relative to the sealing element is preferably the central element described above that is guided through the receiving space and / or the receptacle of the sealing element during the determination of the assembly parameters. In this case, preferably, the central element or the boundary is moved axially relative to the sealing element, in particular reciprocally or reciprocatingly. However, the sealing element can be rotated relative to the receiving space or the boundary, in particular the central element. In this case, the frictional force between the sealing element and the boundary is preferably the torsional frictional force. Accordingly, in this case, the force measured to determine the eigenvalue and / or the deformation is preferably the torsional frictional force.

[0049] At different times during deformation, preferably, the sealing element is deformed to a different extent in each case within the receiving space. Accordingly, preferably, the different times correspond to different movement distances or positions of the fixing element and / or the contact element.

[0050] In particular, a force / displacement curve is recorded to determine the deformation behavior or the frictional behavior and / or to determine the assembly parameters. Preferably, the assembly parameters are determined using the profile of the force / displacement curve. Such determination contributes to the simple, rapid, and / or accurate determination of the assembly parameters.

[0051] Preferably, the force in the force / displacement curve is the force used to deform the sealing element and / or the frictional force between the sealing element and the boundary of the receiving space that is moved relative thereto.

[0052] Preferably, the displacement in the force / displacement curve is the travel distance of the plunger or the fixed element and / or the contact element, the height of the receiving space, or a corresponding displacement.

[0053] Preferably, the sealing element is designed to seal a conveying element for conveying a drug against a guiding element that comprises or forms a receiving space in which the conveying element is guided.

[0054] The sealing element is preferably an annular and / or shaped seal, or a sealing ring, in particular an O-ring.

[0055] Preferably, the sealing element is an individual component that can be inserted into the receiving space. The sealing element is preferably composed of an elastic material. Preferably, the elastic material within the meaning of the present invention is a material having a modulus of elasticity of less than 100 MPa, preferably less than 50 MPa, particularly less than 10 MPa.

[0056] Sealing elements of different batches can be composed of different materials and / or can have different deformation characteristics, different compression set, and / or different creep behavior or creep modulus. A method of separately determining the assembly parameters for each batch ensures that a reliable seal and / or sealing effect is provided in each case even for such different sealing elements or their batches. In particular, due to the precise adjustment of the receiving space volume made possible by using this method, materials that are partially plastic or have a relatively high creep behavior such as thermoplastic elastomers (TPE) can be used for the sealing element. Such sealing elements require a receiving space that is specifically and precisely designed or adapted for each of the sealing elements.

[0057] In yet another aspect that can be implemented independently, the present invention relates to a dispensing device for dispensing a drug. The dispensing device has a conveying element for conveying the drug from a container of the dispensing device, in particular a conveying element movable in the axial direction, a guiding element for guiding the conveying element, and a sealing element, in particular a ring-shaped sealing element, suitable for placement within the receiving space of the guiding element. Preferably, the sealing element is designed as a sealing ring, in particular, to seal the conveying element against the guiding element. Further, preferably, the sealing element can be fixed in the receiving space using a fixing element and / or a contact element that can be fastened to the guiding element. Preferably, the guiding element forms or comprises a pressure chamber of a piston pump, and the conveying element forms the piston of the piston pump.

[0058] Preferably, the fixing element and / or the contact element can be fastened to the guiding element at different axial positions relative to the guiding element. As a result, the sealing element can be fixed or made to conform using specific assembly parameters that are intended for it. As a result, manufacturing tolerances of the sealing element, as well as differences in size and / or material, can be easily taken into account or compensated for, ensuring a reliable seal and / or sealing effect. This contributes to consistent quality in the manufacture or assembly of multiple dispensing devices, particularly in an automated process.

[0059] Preferably, the fixing element and / or the contact element can be locked onto the guiding element at different axial positions relative to the guiding element. This locking facilitates proper or desired positioning of the fixing element and / or the contact element, and thus contributes to easy and error-free assembly. This contributes to consistent quality in the manufacture or assembly of multiple dispensing devices, particularly in an automated process.

[0060] Instead of or in addition to this, preferably, the fixing element and / or the contact element, and / or the guiding element have a positioning device for arranging the fixing element and / or the contact element relative to the guiding element. Preferably, the positioning device has or is formed from one or more locking elements, in particular locking cams. This contributes to the easy assembly and / or positioning of the fixing element and / or the contact element. As a result, the manufacturing tolerances of the sealing element can be taken into account or compensated in a simple manner, and a reliable seal and / or sealing effect can be ensured. This contributes to a consistent quality in the manufacture or assembly of a plurality of dispensing devices, particularly in an automated process.

[0061] Preferably, the positioning device has or is formed from an inclined plane or a spiral structure. This contributes to the easy adjustment of the position of the fixing element and / or the contact element relative to the guiding element.

[0062] Preferably, the positioning device is arranged on the end face of the fixing element and / or the contact element, and / or the guiding element.

[0063] In particular, it is preferable that the rotational position of the fixing element and / or the contact element relative to the guiding element or the dispensing device determines the axial position of the fixing element and / or the contact element. In particular, the positioning device is designed accordingly.

[0064] Preferably, a specific deformation or deformation value of the sealing element, and / or the size or volume of the receiving space can be changed or adapted to each other by changing the position of the fixing element, such that they are determined by the position of the fixing element and / or the contact element relative to the guiding element.

[0065] The above and following aspects and features of the present invention can be combined with each other in different combinations, but can also be implemented independently of each other.

[0066] Still other aspects, features, advantages, and characteristics of the present invention will be found in the following description of the preferred embodiments with reference to the claims and the drawings.

Brief Description of the Drawings

[0067]

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 4E

Figure 5A

Figure 5B

Figure 5C

Figure 6

Mode for Carrying Out the Invention

[0068] In these drawings, which are not to exact scale but are only schematic, the same reference signs are used for equivalent or similar parts. Even when redundant descriptions are omitted for clarity purposes, corresponding or equivalent characteristics and advantages can be provided.

[0069] Figures 1 and 2 show the proposed dispensing device 1 for dispensing drug 2. In particular, the dispensing device 1 is designed as a nebulizer and / or to spray drug 2. Drug 2 is preferably a fluid, in particular a liquid.

[0070] Figure 1 shows a schematic cross - section of the dispensing device 1 in a first state, in this case the non - trigger - waiting state, and Figure 2 shows the dispensing device 1 in a second state, in this case the trigger - waiting state.

[0071] The dispensing device 1 is preferably designed as a portable, transportable, and / or mobile dispensing device 1.

[0072] When drug 2 is sprayed using the dispensing device 1, preferably an aerosol 14 is formed. In particular, the aerosol 14 can be inhaled by a user (not shown) by breathing. Thus, the dispensing device 1 is preferably designed as an inhaler.

[0073] Normally, this inhalation is preferably performed at least once a day, in particular several times a day, for a pre - specified period, preferably depending on the patient's illness.

[0074] Preferably, the aerosol 14 is particularly suitable for breathing, i.e., it is a particle / air mixture of solid particles and / or liquid particles with a diameter that is particularly at least partially or on average smaller than 5 μm.

[0075] The dispensing device 1 preferably does not require injection gas, that is, preferably operates without using injection gas. Instead, the dispensing device 1 preferably operates using a mechanical pressure generator 5 and / or a mechanism for generating the aerosol 14. In particular, it is a mechanically operated pump that places the drug 2 under pressure, and as a result, generates the aerosol 14 when the drug 2 is discharged from the discharge nozzle 12. However, in principle, the dispensing device 1 can be driven or operated in a different, preferably mechanical manner.

[0076] The dispensing device 1 has a preferably insertable and preferably replaceable container 3 containing a substance and / or the drug 2. Preferably, the container 3 forms a reservoir for the drug 2 to be sprayed.

[0077] Preferably, the container 3 can supply up to, for example, 200 dosing units, that is, contain a sufficient amount of the drug 2 to enable spraying or application up to, for example, 200 times. Typical containers 3 disclosed in WO 96 / 06011 A2 or WO 00 / 49988 A2 have a volume from about 2 ml to 10 ml.

[0078] The container 3 is preferably substantially cylindrical or cartridge-shaped. In the illustrated example, the container 3 can be inserted into the dispensing device 1 from below and optionally replaced after the dispensing device 1 is opened. However, the container 3 can be made non-replaceable, and the dispensing device 1 can be made disposable.

[0079] The container 3 is preferably at least substantially rigid. The container 3 is particularly preferably made of a plastic material, especially a thermoplastic material, very preferably polypropylene. The container 3 preferably has a flat surface on its bottom or a flat container bottom 21.

[0080] Preferably, the drug 2 is received in a fluid space 4 formed by a crushable pouch in the container 3.

[0081] Preferably, the dispensing device 1 also comprises a preferably mechanical pressure generator 5 for conveying and spraying a pre-specified and optionally adjustable dose of the drug 2 in each case. Preferably, the pressure generator 5 forms a high-precision pump or a dosing pump, in particular a piston pump.

[0082] Preferably, the pressure generator 5, which is only partially shown in this example, has a drive spring 7 for driving the pressure generator 5. Preferably, the drive spring 7 is designed to mechanically accumulate energy in particular and deliver it to the pressure generator 5 such that an aerosol 14 is formed from the drug 2 when the pressure generator 5 pressurizes the drug 2 and as a result the drug 2 is discharged from the discharge nozzle 12. Thus, the pressure generator 5 is driven by the drive spring 7 or the energy made available thereby.

[0083] Preferably, the pressure generator 5 has a container 3, an attached drive unit, in particular in the form of the drive spring 7 which is only partially shown, and a holder 6 for a tubular conveying element 9, a check valve 10, and / or a pump chamber and / or a pressure chamber 11 in particular.

[0084] Preferably, the dispensing device 1 has a clamping mechanism and / or a locking element 8 designed to preferably automatically lock the drive spring 7 after the injection of energy into the drive spring 7. Preferably, the injection of energy into the drive spring 7 is effected by stretching, pulling, pressing or in particular compressing the drive spring 7. For the sake of simplicity, in the following this operation will be summarized by the term "tensioning" of the drive spring 7, and the state of the drive spring 7 obtained by this tensioning will be assigned the attribute "tensioned" (irrespective of whether in a particular embodiment the particular drive spring is stretched or compressed for this purpose). After tensioning or compression, preferably the drive spring 7 is kept in an energetically highly charged state and / or a loaded state or a tensioned state by a locking element 8 which can be actuated in particular manually. In particular, the energy stored in the drive spring 7 by tensioning is released and / or utilized by actuation of the locking element 8 (either directly or preferably via the trigger button 8a) in order to generate pressure in the pressure generator 5.

[0085] The drive spring 7 is preferably a spiral spring or a helical spring, and energy is stored or introduced by axial compression of the drive spring 7.

[0086] Preferably, the dispensing device 1 and / or the pressure generator 5 has a discharge nozzle 12, in particular in the region of an optional mouthpiece 13.

[0087] Preferably, the container 3 is fixed in the dispensing device 1 by the holder 6 in a locking manner in particular or fluidly connected to the conveying element 9 such that the conveying element 9 enters the container 3. The holder 6 can be designed such that the container 3 can be detached and exchanged.

[0088] When energy is injected into the drive spring 7 and / or when the drive spring 7 is tensioned, the holder 6 is moved downwards in the drawing together with the container 3 and the conveying element 9 (i.e. in the example shown the drive spring 7 is axially compressed), and the drug 2 is sucked from the container 3 through the non-return valve 10 into the pressure chamber 11 of the pressure generator 5.

[0089] During the subsequent load removal or decompression of the drive spring 7 after triggering by the actuation of the blocking element 8, the drug 2 in the pressure chamber 11 is pressurized by the conveying element 9, pushed upward by the check valve 10 which is closed at this point of the conveying element 9, and / or transferred into the pressure chamber 11 by the drive spring 7. Thus, the conveying element 9 functions as a plunger. This pressure discharges the drug 2 through the discharge nozzle 12, where it is sprayed as shown in FIG. 1 to form the aerosol 14.

[0090] Since the conveying element 9 or the check valve 10 acts as a plunger, the movement of the conveying element 9 or the container 3 corresponds to the volume displaced within the pressure chamber 11 or the amount of drug released and / or releasable.

[0091] A user or patient not shown can inhale the sprayed drug 2 and / or the aerosol 14, and preferably can aspirate air into the mouthpiece 13 through at least one optional air supply opening 15.

[0092] In the example shown, preferably, the dispensing device 1 has an upper housing part 16 and an inner part 17 (inner housing part) (see FIG. 2) which is rotatable relative thereto and has an upper part 17a and a lower part 17b (see FIG. 1). A lower housing part 18 and / or a cap which can be actuated or rotated manually in particular are preferably fastened, in a separable or non-detachable manner, by a holding element 19 to this inner part 17.

[0093] To insert and / or replace the container 3, preferably, the lower housing part 18 can be detached from the dispensing device 1. However, the container 3 can be made non-replaceable.

[0094] The lower housing part 18 can preferably be rotated relative to the upper housing part 16 or with respect to the upper housing part 16 while carrying along the lower part 17b of the inner part 17 shown in the figure.

[0095] In particular, the lower housing part 18 is arranged on the inner part 17 in a rotationally fixed manner, preferably connected to the inner part 17 by positive engagement. In this way, the inner part 17 can be rotated relative to or with respect to the housing part 16 using the lower housing part 18. However, in this case, other solutions are also possible.

[0096] As a result of rotating the upper housing part 16 relative to the lower housing part 18 or the inner part 17, the drive spring 7 is axially loaded, in particular compressed, by a gear mechanism (not shown) acting on the holder 6. By means of a clamp, preferably the container 3 is moved axially downwards until it occupies the end position shown in Figure 2. In this state, the drive spring 7 is loaded and / or the dispensing device 1 is waiting for dispensing. During the spraying process, preferably the container 3 is pulled back (upwards) to the starting position by the drive spring 7.

[0097] Preferably, the container 3 performs axial movement or lifting movement during the addition of energy and / or during the clamping process and / or for removing fluid and / or during the spraying or dispensing of the drug 2.

[0098] Preferably, when the drive spring 7 is first loaded or tensioned, the ventilation opening of the container 3 is opened. Preferably, this opening is preferably made for ventilation during the first contact using a device having a piercing element 22 arranged in the housing part 18 and / or piercing a seal on the container 3 and / or its bottom surface. Preferably, the piercing element 22 is arranged on an axially acting spring 20 which comes into contact with the container bottom surface 21 when first loaded.

[0099] Figure 3 shows the pressure generator 5 of the dispensing device 1 in more detail, but not to scale.

[0100] Preferably, the dispensing device 1 and / or the pressure generator 5 are designed to dispense, in particular to pump-feed or administer, the drug 2, preferably a liquid. Particularly preferably, the pressure generator 5 is designed as a piston pump. In particular, the dispensing device 1 and / or the pressure generator 5 are designed for very small pump volumes or dosages. In the illustrated example, the pump volume is preferably greater than 1 μl, in particular greater than 5 μl, per piston stroke and / or less than 1 ml, in particular 500 μl, particularly preferably 100 μl, very preferably 30 μl, and in particular substantially between 10 and 20 μl.

[0101] It is necessary that air does not enter the pressure generator 5 when it is not in use, in particular so as to ensure accurate conveyance and administration of a desired volume when the dispensing device 1 is operated for the first time after a long period of non-use. Otherwise, the administration will no longer have the desired accuracy.

[0102] The dispensing device 1 and / or the pressure generator 5 preferably have an axis A. Preferably, the axis A corresponds to the main axis, longitudinal axis, and / or axis of symmetry of the pressure generator 5 or the conveying element 9, and / or the movement axis of the conveying element 9. In particular, the pressure generator 5 extends substantially longitudinally along the axis A.

[0103] The designations “axial direction” and “radial direction” refer in particular to the axis A. Thus, the direction, extension, or movement in the “axial direction” is preferably parallel to the axis A, and the direction, extension, or movement in the “radial direction” is preferably radial with respect to the axis A.

[0104] Preferably, the dispensing device 1 and / or the pressure generator 5 have a guide element 23 for guiding the conveying element 9, a sealing element 24, a receiving space 27 for receiving the sealing element 24, and fixing elements 25 and / or contact elements 26 for fixing or clamping and / or deforming the sealing element 24, in particular within the receiving space 27.

[0105] In the (fully assembled) dispensing device 1, the sealing element 24 is arranged in the receiving space 27.

[0106] Preferably, the fixing element 25 is fixed and / or fastened to the guiding element 23 and / or can be fixed or fastened to the guiding element 23 within the fully assembled dispensing device 1.

[0107] Preferably, the fixing element 25 is designed to fix or seat the sealing element 24 within the receiving space 27.

[0108] Preferably, the contact element 26 is designed to contact the sealing element 24 and / or to be brought into contact with the sealing element 24. Preferably, the contact element 26 can be arranged or is arranged between the sealing element 24 and the fixing element 25.

[0109] Preferably, the position of the contact element 26 can be fixed or determined by the fixing element 25. Preferably, the fixing element 25 can be fastened to the contact element 26, for example, by crimping, screwing, gluing, or welding. This fastening is shown in Figure 3.

[0110] In the illustrated example, the fixing element 25 and the contact element 26 are formed by two separate components.

[0111] The two-part design of the fixing element 25 and the contact element 26 has the advantage that, for example, the fixing element 25 and the contact element 26 can be more precisely optimized to meet each of these requirements. For example, for the contact element 26, a particularly good fit into the receiving space 27 with only low tolerances is important to ensure good sealing. Therefore, the contact element 26 should have the smallest possible manufacturing tolerances that are not as important for the fixing element 25. On the other hand, the fixing element 25 can be optimized, for example, to fit a material bond, a positive connection, or a non-positive connection with the pressure generator 5 or the guiding element 23 or another component, especially a component for fixing the axial position.

[0112] Furthermore, in one embodiment, the contact element 26 and the fixing element 25 can be manufactured as separate components from different materials. For example, the contact element 26 can be made of a material that is dimensionally more stable and / or tougher or harder than the fixing element 25, and / or the fixing element 25 can be made of a material that is softer or more ductile than the contact element 26. A "more ductile material" is in particular a material having a higher ductility, and the term "ductility" refers to the material property of permanently deforming, in particular plastically deforming, before breaking under shear stress. Overall, the flexibility in manufacturing and / or the use of the individual components is increased, and the manufacturing process can be optimized.

[0113] Another advantage of the contact element 26 and the fixing element 25 as separate components is that the requirements for the components can be more precisely met by selecting different materials for these components. A harder and / or dimensionally more stable material for the contact element 26 makes it possible to permanently and / or invariantly fix the sealing element 24 in the receiving space 27, and thus is preferable by ensuring a permanent and / or invariant seal by the sealing element 24. A softer and / or more ductile material for the fixing element 25 is preferable by facilitating or enabling preferably a deformation-based fastening of the fixing element 25 to the guiding element 23 by pressing or crimping. Thus, overall, the selection of different materials for the contact element 26 and the fixing element 25 is advantageous for meeting their requirements.

[0114] However, it is also possible to design the contact element 26 as a single part having the fixing element 25 or the fixing element 25 as a single part having the contact element 26, and / or for the contact element 26 to constitute or form a part of the fixing element 25. The single-part design achieves fewer components, but is only one option.

[0115] Preferably, the guide element 23 is designed as a guide tube and / or preferably forms a particularly elongated and / or straight channel 23b for receiving or guiding the conveying element 9 in a longitudinally displaceable manner. Preferably, the conveying element 9 can be arranged in the guide element 23 or, in the case of a pressure generator 5 or a dispensing device 1 that is completely assembled, can be arranged or guided within the guide element 23. Preferably, the conveying element 9 can be guided in a manner that moves relative to the guide element 23, particularly in a longitudinally or axially displaceable manner within the guide element 23 or the channel 23b.

[0116] Preferably, the conveying element 9 forms a piston and / or the guide element 23 forms a cylinder and / or a hollow cylinder. Preferably, the guide element 23 and the conveying element 9 together form a cylinder / piston arrangement, particularly a piston pump or a part thereof.

[0117] Preferably, as shown in FIG. 3, the conveying element 9 defines the boundary of the pump space and / or the pressure chamber 11 within the guide element 23. Preferably, the conveying element 9 is provided, in particular, with a check valve 10 arranged on the end of the conveying element 9 facing the pressure chamber 11.

[0118] In the illustrated example, preferably, the hollow conveying element 9 forms or includes a supply channel 28 for the drug 2. By corresponding axial movement, the drug 2 can be conveyed, particularly sucked, through the supply channel 28 and through the inlet valve or check valve 10 into the pressure chamber 11.

[0119] On the pressure side or the discharge side, the pressure generator 5 optionally has an outlet valve (not shown) and, in particular, a discharge nozzle 12 for dispensing and optionally spraying the drug 2.

[0120] The pressure generator 5 according to the proposal or the dispensing device 1 according to the proposal is in particular designed as a nebulizer or inhaler in the illustrated example. The drug 2 is alternately sucked into the pressure chamber 11 through the supply channel 28 by the conveying element 9 corresponding reciprocating movement, or pressurized in the pressure chamber 11 and discharged through the discharge nozzle 12, thereby being administered, preferably, sprayed. That is, as shown in FIG. 3, a spray mist or aerosol 14 is formed from the drug 2.

[0121] In the non-trigger standby state shown in FIG. 1, preferably, the pressure chamber 11 is reduced or minimized compared to the trigger standby state or the loading state shown in FIG. 2. In other words, preferably, the conveying element 9 and / or the piston enter into the pressure chamber 11 when the pressure chamber 11 is in the non-trigger standby state. In the trigger standby state or the loading state, preferably, the conveying element 9 and / or the piston are far away from the discharge nozzle 12 compared to the non-trigger standby state shown in FIG. 1, and / or retreat from the pressure chamber 11.

[0122] Preferably, the dispensing device 1, the pressure generator 5, and / or the guiding element 23 have a receiving space 27 for the sealing element 24 or in particular form or define the boundary of the receiving space 27 together with the contact element 26.

[0123] The guiding element 23 preferably (at least partially) has, forms or at least partially defines the receiving space 27 on the outer surface and / or the axial end or end face facing the dispensing end, the pressure chamber 11, and / or the discharge nozzle 12.

[0124] If necessary, the receiving space 27 can be formed separately from the guiding element 23. In this case, preferably, the receiving space 27 and / or the component having or forming it are in contact with or surround the guiding element 23.

[0125] The receiving space 27 is designed, in particular as a recess within the guide element 23, particularly preferably as a groove or annular groove, an annular shoulder portion, or a bushing.

[0126] Preferably, the volume of the receiving space 27 is established by the radial extent and / or width B of the receiving space 27 within the guide element 23 and the axial height H of the receiving space 27.

[0127] Preferably, the receiving space 27 is at least partially bounded by the guide element 23 and the contact element 26 and / or the fixing element 25. The guide element 23 can form a cylindrical or hollow cylindrical guide or receptacle for the contact element 26 and / or the fixing element 25.

[0128] Preferably, the receiving space 27 radially and / or annularly surrounds the conveying element 9.

[0129] Preferably, the conveying element 9 forms the inner radial boundary of the receiving space 27.

[0130] Preferably, the guide element 23 forms the axial and / or radial outer boundary for the receiving space 27.

[0131] In the illustrated example, the conveying element 9 has a circular cross-section with a diameter greater than 0.25 mm, preferably greater than 0.5 mm, particularly greater than 0.75 mm, and / or less than 4 mm, preferably less than 3 mm, particularly less than 2.25 mm.

[0132] Preferably, the conveying element 9 is made of metal, particularly stainless steel. The conveying element 9 is designed in particular as a hollow element or a capillary.

[0133] Preferably, the conveying element 9 is drawn and thus has a relatively small tolerance with respect to its diameter.

[0134] Preferably, the sealing element 24 is at least partially deformable. Preferably, the degree and / or manner of deformation of the sealing element 24 is specified by a deformation value.

[0135] Preferably, the sealing element 24 is designed in the form of a continuous ring or as a molded seal or sealing ring that is particularly adapted to be received within the receiving space 27.

[0136] Preferably, the sealing element 24 has an opening 24a, particularly a central opening.

[0137] In particular, the sealing element 24 is an O-ring that has at least substantially a circular cross-section in an uninstalled or undeformed state, as shown in Figure 5B. However, the sealing element 24 can in particular be embodied as any other form of seal that has a non-circular cross-section in an undeformed state.

[0138] In the undeformed state, preferably, the sealing element 24 has a different cross-section or different volume than the receiving space 27 of the dispensing device 1 (fully assembled). Thus, the sealing element 24 is preferably deformed during the assembly of the dispensing device 1, particularly when the contact element 26 and / or the fixing element 25 are fastened to the guiding element 23. The elastic tension of the sealing element 24 is brought about due to the deformation of the sealing element 24, and this elastic tension contributes to the optimal sealing effect of the sealing element 24 and / or enables or achieves the sealing using the sealing element 24.

[0139] Preferably, the deformation or deformation value of the sealing element 24 is not directly definable or adjustable, but is determined in particular using or derived from characteristic values that correlate with these. By using the assembly parameter M, in particular, it is possible to ensure that a desired deformation of the sealing element 24 is provided in the fully assembled dispensing device 1 and / or that the deformation value of the sealing element 24 assumes a desired value.

[0140] Preferably, the plurality of sealing elements 24 are manufactured in batches, i.e., in groups. In particular, the batches are manufactured from a specific amount of starting material that is as uniform as possible. Preferably, one batch of sealing elements 24 has only minor variations and / or a high level of reproducibility with respect to important variables such as ring diameter or effective ring diameter, cross-sectional area, volume, or compressibility.

[0141] Particularly preferably, the deviation of the volume of one batch of sealing elements 24 from the average volume or target volume of these sealing elements is less than 10%, particularly less than 5%, and particularly preferably less than 4% or 2%.

[0142] In a specific example, the sealing element 24 is greater than 5 mm 3 and / or less than 10 mm 3 and particularly preferably has a target volume or average volume of from about 7 mm 3 to 8 mm 3 and all of the sealing elements 24 of the batch have a volume that deviates from this target volume or average volume by a maximum of 0.3 mm 3 at most.

[0143] The sealing elements 24 are preferably manufactured by injection molding, in particular using an injection molding tool (not shown) having a plurality of cavities. Thus, a plurality of sealing elements 24 are manufactured during each injection molding process.

[0144] Preferably, the sealing elements 24 are individual parts and / or individual components, in particular in the form of O-rings or sealing rings. However, alternatively, the sealing elements 24 can be formed directly on the guide element 23 or the contact element 26, in particular using two-component injection molding. In this case, therefore, the batch is considered to consist not only of the sealing elements 24 as described above, but also of the guide element 23 or the contact element 26 on or in which the sealing elements 24 are formed.

[0145] The sealing element 24 can, in particular, vary from batch to batch with respect to important variables such as the ring diameter or the effective ring diameter, the cross-sectional area, the volume, or the compressibility. Variables such as the compressibility determined by the material or the technology, as well as the quantities determined by the tool (ring diameter, thickness, volume, surface properties) are variable.

[0146] Preferably, the sealing elements 24 of different batches differ only with respect to the manufacturing tolerances obtained in manufacturing in different batches.

[0147] However, the sealing elements of different batches can also differ significantly from one another, in particular, have fundamentally different (nominal) dimensions, be composed of different materials, have different deformation properties, for example, different compression elastic moduli, elastic moduli, compression hardnesses, and / or indentation hardnesses, and / or have different compression permanent deformations.

[0148] Preferably, the sealing element 24 is designed to seal the conveying element 9 from the guiding element 23, in particular, in an airtight manner or in an anti-diffusion sealing manner. In particular, the sealing element 24 is designed or arranged so that no drug 2 or fluid, in particular, no gas and / or liquid leaks from the pressure chamber 11 and / or between the guiding element 23 and the conveying element 9.

[0149] In the illustrated example, the cross-sectional area or the (effective) thickness D of the non-installed sealing element 24 is preferably greater than 0.3 mm, in particular, greater than 0.5 mm, particularly preferably greater than or equal to 1 mm, and / or less than 3 mm, less than 2 mm, more preferably less than 1.5 mm. Preferably, the inner diameter or the size of the central opening 24a of the sealing element 24 substantially corresponds to the outer diameter of the conveying element 9.

[0150] Preferably, the sealing element 24 is composed of an elastic material. Preferably, the elastic material within the scope of the meaning of the present invention is a material having an elastic modulus less than 100 MPa, preferably less than 50 MPa, particularly preferably less than 10 MPa.

[0151] Preferably, the sealing element 24 is composed of a rubber elastic material or natural rubber suitable for pharmaceuticals or foodstuffs. Preferably, the sealing element 24 is made of silicone, fluorinated rubber (FKM), thermoplastic elastomer (TPE), ethylene-propylene-diene rubber (EPDM), chloro-isobutene-isoprene rubber or chlorobutyl rubber (CIIR), bromobutyl rubber (BIIR), polyurethane (PUR), and / or nitrile rubber (NBR).

[0152] The different materials that can be considered for the sealing element 24 have different properties. On the one hand, there are materials that have a high leakage rate and / or low anti-diffusion sealing performance when in contact with pharmaceuticals at high temperatures and / or high pressures. Thus, in other words, when in contact with pharmaceuticals at high temperatures or high pressures, there is a high amount of diffusion through the sealing element 24, reducing the sealing effect of the sealing element 24.

[0153] Using a sealing element 24 composed of such materials makes it difficult to achieve static sealing or good storage sealing performance because substances can diffuse through the sealing material or the sealing element 24. In this case, preferably, the diffusion loss is proportional to the size of the free surface, in particular, and / or inversely proportional to the spread of the sealing element 24 in the diffusion direction.

[0154] Furthermore, there are materials in which the contact stress on the sealing surface of the sealing element 24, i.e., the surface in contact with the boundary of the receiving space 27 in particular, decreases at high temperatures and / or high pressures. In other words, creep of the material or the sealing element 24 is observed in these materials under high pressure and / or high temperature.

[0155] In this case, in particular, when the compressive stress of the sealing material or the sealing element 24 against the opposing surface, in this case, in particular, the surface of the conveying element 9, is excessively low, the roughness or porosity of this surface causes leakage, resulting in storage leakage and / or insufficient static sealing.

[0156] Accordingly, the problem associated with the sealing of the conveying element 9 by the sealing element 24 is to satisfy, in particular, two effectively opposing requirements. On the one hand, as long as storage leakage is avoided and / or the static seal can be improved, a high tensile pressure or strong deformation of the sealing element 24 within the receiving space 27 is desirable or advantageous. However, on the other hand, a high preload pressure or severe deformation of the sealing element 24 increases the preload pressure and the creep and / or flow of the material, and further increases the wear resulting from the relative movement between the conveying element 9 and the sealing element 24, meaning that the dynamic seal during the movement of the conveying element 9 with respect to the sealing element 24, i.e., the sealing of the conveying element 9, deteriorates. Furthermore, an overly high preload pressure not only causes an increase in wear but also makes the operation or movement of the conveying element 9 more difficult. This results in a conveying element 9 that does not move or does not move as desired, and thus, for example, in the delivery stroke, an overly small dose of the drug 2 may be released and / or only insufficient spraying may occur.

[0157] In particular, the deformation value is a measure of how much the sealing element 24 is deformed and / or the ratio between the cross-sectional area or volume of the (deformed) sealing element 24 and the cross-sectional area or volume of the receiving space 27 in the fully assembled dispensing device 1. Accordingly, the deformation value is, in particular, a measure of how strong the elastic tension of the sealing element 24 is in the receiving space 27.

[0158] The sealing element 24 must, in particular, be deformed and / or the deformation value of the sealing element 24 must be selected or adjusted such that the above-mentioned opposing requirements are satisfied optimally as much as possible. On the one hand, the deformation must be large enough so that there is elastic tension within the sealing element 24, and as a result, storage leakage can be prevented. On the other hand, the deformation must be small enough so that a good dynamic seal is ensured and / or creep of the material is prevented.

[0159] The proposed method for installing the sealing element 24 and the proposed dispensing device 1 are in particular intended to ensure that the sealing element 24 is placed in the receiving space 27 or fixed within the receiving space 27 using a preload pressure that enables both good static and dynamic sealing to be implemented or achieved. Furthermore, preferably, the proposed method is suitable for a number of materials and / or different materials.

[0160] In the assembled state, i.e., with the pressure generator 5 installed, the sealing element 24 is at least substantially received within the receiving space 27, as shown in FIG. 3. Preferably, the contact element 26 or the fixing element 25 is placed axially on the sealing element 24 to axially fix the sealing element 24 within the receiving space 27. Furthermore, preferably, the sealing element 24 is in sealing contact radially with the conveying element 9 passing through it. The sealing element 24 is in particular clamped or compressed, i.e., deformed, within the receiving space 27 in the installed state. In the installed state, preferably, the sealing element 24 has a substantially rectangular cross-sectional shape or at least one flat contact side facing the conveying element 9.

[0161] To achieve good sealing and corresponding accurate dosing, the desired filling degree, i.e., the "target filling degree", is preferably greater than 90% on average, in particular greater than 95%, and / or less than 110%, in particular less than 105%, with a tolerance of only 4%, 2%, or less. Particularly preferably, it is at least substantially 100%.

[0162] The "filling degree" corresponds to the ratio of the volume of the undeformed sealing element 24 (in particular shown in FIG. 5B) divided by the volume of the receiving space 27. Preferably, the method according to the invention and the proposed dispensing device 1 are designed to implement or reproduce this filling degree or any other desired filling degree.

[0163] Preferably, the volume of the receiving space 27 can be adjusted and / or fixed in a variable manner and / or by assembly or during assembly.

[0164] In the illustrated example, preferably, the contact element 26 is fixed or fastened to the guide element 23 by the fixing element 25, particularly at a position where the fixing element 25 is axially tensioned with respect to the sealing element 24. The defined position of the contact element 26, and thus the defined axial length or height H of the receiving space 27 with respect to the sealing element 24, can be achieved using corresponding axial and / or end face contact surfaces.

[0165] As shown in FIG. 3, the height H of the receiving space 27 is, in particular, the (axial) distance between the bottom surface 27a, the annular surface, or the annular shoulder portion of the receiving space 27 formed by the guide element 23, and the end face of the contact element 26 facing the bottom surface 27a and / or the sealing element 24, and / or the end face of the contact portion 26a of the contact element 26.

[0166] Preferably, the fixing element 25 is designed in a cap manner and / or overlaps the contact element 26 on the end face or on the free end.

[0167] Preferably, the contact element 26 is at least substantially ring-shaped. Preferably, the contact element has a central opening. Preferably, the diameter of the central opening corresponds to the diameter of the channel 23b or is larger than the diameter of the channel 23b and / or the conveying element 9.

[0168] Preferably, the contact element 26 has a contact portion 26a designed for direct contact with the sealing element 24. The contact portion 26a is formed, in particular, by the portion of the contact element 26 at the axial end. In the fully assembled dispensing device 1, preferably, the contact portion 26a contacts the sealing element 24 and / or fixes the sealing element 24 in the receiving space 27 or clamps the sealing element 24a in the receiving space 27.

[0169] The end face of the contact portion 26a facing the sealing element 24 is preferably curved in the radial direction and / or conforms to the shape of the sealing ring or sealing element 24. In this way, it is possible to reduce or minimize the voids, particularly the regions within the receiving space 27 that are not filled by the sealing element 24. Preferably, the contact portion 26a has a sealing lip portion facing the sealing element 24. Preferably, the sealing lip portion functions as a protruding barrier and / or is designed to prevent the sealing element 24 from creeping into the channel 23b.

[0170] Preferably, the contact portion 26a has a ring-shaped cross-section (i.e., a cross-section perpendicular to the axis A), particularly in the form of a circular ring.

[0171] Preferably, the contact element 26 has a contact surface and / or a stop 26b against the fixed element 25. In particular, the stop 26b is formed by an annular shoulder or flange of the fixed element 25.

[0172] Preferably, the fixed element 25 has an opposing surface 25a assigned to the stop 26b so as to contact the stop 26b and / or hold or fix the stop 26b, and thus the contact element 26, in the axial direction.

[0173] Preferably, the contact element 26 has a particularly conical insertion portion 26c that facilitates the insertion of the conveying element 9 into it. Instead of or in addition to this, the insertion of the plunger 29 or the central element 30 during the determination of the assembly parameter M is also facilitated by the insertion portion 26c. Preferably, the insertion portion 26c has or is formed by a bevel and / or rounding. In particular, the central opening of the contact element 26 is widened or enlarged by the bevel / rounding towards the insertion portion 26c and / or the free end of the contact element 26.

[0174] Preferably, the position of the fixing element 25, particularly the axial position, is variable. Preferably, the fixing element 25 can be fastened to the guiding element 23 at various, particularly axial positions relative to the guiding element 23. For this purpose, preferably, the guiding element 23 has a fastening portion 23a. Preferably, the fastening portion 23a is arranged or formed on the circumferential side surface of the guiding element 23.

[0175] In the example shown in FIG. 4, preferably, the fastening portion 23a has one or more engagement options such as a recess 23c or threading. However, the fastening portion 23a can have a different design, for example, it can have or be formed by an adhesive surface.

[0176] Preferably, the fixing element 25 and / or the contact element 26 can be fastened to the guiding element 23 at different discrete positions relative to the guiding element 23. The "discrete positions" within the scope of the present invention are positions defined or fixed, in particular, by the shape of the fixing element 25, the contact element 26, and / or the guiding element 23 and / or the fastening portion 23a.

[0177] The fixing element 25 is fixed, for example, by screwing or gluing as shown in FIG. 3, or, for example, by deformation while simultaneously forming one or more linear marks, and / or, as shown in FIG. 4E, preferably, it can be fastened to the guiding element 23 by engaging particularly radially within one or more recesses 23c of the guiding element 23. In particular, the guiding element 23 and / or the fastening portion 23a can have a plurality of recesses 23c arranged at different axial positions.

[0178] In particular, the plurality of discrete positions of the fixing element 25 and / or the contact element 26 relative to the guiding element 23 are defined or implemented by the plurality of recesses 23c. In other words, the fixing element 25 and / or the contact element 26 can be preferably fastened to the guiding element 23 by the recesses 23c at different discrete positions relative to the guiding element 23. In particular, the axial position of the fixing element 25 and / or the contact element 26, and thus the height H and ultimately the volume of the receiving space 27, can be adjusted or changed.

[0179] In other words, in the fully assembled dispensing device 1, it is preferred to fasten the fixing element 25 at a fixed or defined position on the guiding element 23 and / or the fastening part 23a, and / or to fix the fixing element 25 and / or the contact element 26 at a fixed and / or non - adjustable position relative to the guiding element 23. However, during the fixing and / or fastening of the fixing element 25 and / or the contact element 26, different, especially axial and / or discrete positions relative to the guiding element 23 can be selected and / or implemented. In this way, in particular, the ratio of the volume of the receiving space 27 to the volume of the sealing element 24, or to the volume of the receiving space 27 relative to the volume of the sealing element 24, can be selected and / or adapted. The function of changing the position of the fixing element 25 and / or the contact element 26 during assembly forms an aspect of the invention that can be carried out independently, in particular.

[0180] In particular, the position of the fixing element 25 and / or the contact element 26 is determined such that the deformation of the sealing element 24 and / or the size or volume of the receiving space 27 can be changed by changing the support of the fixing element 25 and / or the contact element 26.

[0181] Preferably, there are different options for fastening the fixing element 25 to the guiding element 23. The fixing element 25 can be fastened to the guiding element 23 in a non - indexing manner, an indexing manner, and / or a material - bonding manner.

[0182] Preferred options for fastening the fixing element 25 are screwing the fixing element 25, (indexing) fastening using a pin, primary - forming fastening (e.g., forming, or material bonding using a curable resin, especially a UV - curable resin and / or an adhesive), fastening by forming (e.g., crimping or heat caulking), milling, welding, or soldering, etc.

[0183] In one example, the fixing element 25 can be designed as a nut or a union nut and can be fastened to the guide element 23 by screwing with a specifically defined torque at a position specified by the assembly parameter M. Preferably, the thread used in this case is designed as a coarse thread and / or without an automatic locking function. This is shown by the example described in FIG. 3.

[0184] In yet another example, the fixing element 25 can be designed as a crimp sleeve and can be rigidly crimped at a position specified by the assembly parameter M on the guide element 23 and / or the fastening part 23a.

[0185] For this purpose, the guide element 23 can have or be formed by one or more recesses 23c. Preferably, the recesses 23c are arranged on the outer surface of the guide element 23. In particular, the recesses 23c correspond to different (axial) positions and / or discrete positions of the fixing element 25 and / or define different axial positions and / or discrete positions of the fixing element 25 and / or the contact element 26. This is shown by way of example according to FIGS. 4A to 4E.

[0186] Preferably, the recesses 23c are designed as grooves or striations. The recesses 23c, in particular the grooves or striations, can be continuous, and / or the guide element 23 can be formed to encircle the outer circumference, and / or can be formed by a plurality of individual recesses 23c that are separated from each other in the circumferential direction.

[0187] In the embodiment having a plurality of recesses 23c shown in FIGS. 4A to 4E, preferably, the fixing element 25 can be fastened or fixed on the guide element 23 at different discrete positions corresponding to the individual recesses 23c in particular.

[0188] Alternatively or in addition thereto, only one or exactly one such recess 23c or groove or striation can be provided, and a plurality of crimp sleeves having different axial lengths are provided such that different assembly parameters M correspond to different fixing elements 25 and / or such that crimp sleeves having different axial lengths are implemented by different fixing elements 25.

[0189] The fixing element 25 can be preformed to be suitable for engagement with the recess 23c, for example, by having a peripheral edge or an edge designed to correspond to the recess 23c in any other way for engaging the recess 23c. However, this preformation is not essential. The discrete positions of the fixing element 25 and / or the contact element 26 are also defined by such deformation of the fixing element 25 in combination with the recess 23c. The fixing element 25 does not have such a preformed shape, only the guiding element 23 and / or the fastening part 23a have one or more recesses 23c, the fixing element 25 is continuously displaceable relative to the guiding element 23 and / or the fastening part 23a, and it is also possible that a deformation tool deforms the fixing element 25 to insert it into the recess 23c in order to fasten or fix the fixing element 25.

[0190] In yet another example, the fixing element 25 can be fixed to the guiding element 23 by gluing or welding, in particular by laser welding, ultrasonic welding, and / or friction welding, at a position specified by the assembly parameter M.

[0191] Optionally, the fixing element 25 can be fastened to the contact element 26, in which case the fastening element 25 can be fastened to the contact element 26 in the same way as it is fastened to the guiding element 23. Accordingly, the above description regarding the fastening of the fixing element 25 to the guiding element 23 also applies equally to the fastening of the fixing element 25 to the contact element 26. Preferably, a firm connection between the contact element 26 and the fixing element 25 is manufactured only after the contact element 26 is arranged.

[0192] In the embodiment illustrated in FIG. 4E, the contact element 26 or its stop 26b has a groove or a striation on the radially outer surface, and the fixing element 25 is deformed by being crimped into this groove or striation or by fastening to the contact element 26.

[0193] FIG. 6 schematically shows a part of the dispensing device 1 and / or the pressure generator 5 according to yet another preferred embodiment. FIG. 6 is a side view of the pressure generator 5 shown in the cross-sectional view described in FIG. 4E, omitting the fixing element 25 and showing only the contact element 26 and the guiding element 23.

[0194] According to the embodiment illustrated in FIG. 6, preferably, the fixing element and / or the contact elements 25, 26 can be locked onto the guiding element 23 at different axial positions and / or discrete positions with respect to the guiding element 23. In particular, the different discrete positions of the fixing element and / or the contact elements 25, 26 with respect to the guiding element 23 can be defined or made in this way.

[0195] Preferably, the fixing element and / or the contact elements 25, 26, and / or the guiding element 23 have a positioning device 31 for arranging the fixing element and / or the contact elements 25, 26 with respect to the guiding element 23. Preferably, the positioning device 31 is formed by or has such surfaces corresponding to each other of the contact element 26 and the guiding element 23.

[0196] Preferably, the positioning device 31 is arranged on the end face of the contact element 26 assigned to or facing the guiding element 23 and / or on the end face of the guiding element 23 assigned to or facing the contact element 26.

[0197] In the illustrated example, the positioning device 31 is formed by or includes in particular one or more spiral structures 31a. Preferably, both the contact element 26 and the guiding element 23 include the spiral structure 31a.

[0198] The position of the contact element 26 relative to the guide element 23 (in particular in the axial direction) can preferably be adjusted or changed using the helical structure 31a. In particular, the position of the contact element 26 relative to the guide element 23 can be changed by rotating the contact element 26 around the axis A or by rotating the contact element 26 relative to the guide element 23. During such rotation, preferably, the helical structure 31a of the contact element 26 and the helical structure 31a of the guide element 23 slide along each other, thereby changing the axial position of the guide element 23 and the contact element 26 relative to each other.

[0199] However, instead of the helical structure 31a, it is possible to provide only an inclined plane or an inclined surface, etc.

[0200] Preferably, in particular, the axial position of the fixing element 25 and / or the contact element 26 relative to the guide element 23 can be fixed or made so by the rotational position of the fixing element 25 and / or the contact element 26. Preferably, this fixing of the axial position is made possible or implemented by the positioning device 31, in particular by an inclined plane or an inclined surface or the helical structure 31a.

[0201] Preferably, the positioning device 31 has or is formed by one or more locking elements 31b. In particular, the contact element 26 can be locked on the guide element 23 by the locking element 31b at a (defined) axial position relative to the guide element 23.

[0202] Preferably, the contact element 26 and the guide element 23 have corresponding locking elements 31b.

[0203] In particular, the locking element 31b of the contact element 26 and the locking element 31b of the guide element 23 are designed to engage or interact with each other.

[0204] Particularly preferably, the locking element 31b is designed such that the rotation of the contact element 26 relative to the guide element 23 is only possible in one rotational direction around the axis A, and rotation in the direction opposite to this rotational direction is prevented. As shown in FIG. 6, this design can be achieved by appropriately designing the locking element 31B having an inclined surface and a vertical surface.

[0205] When the contact element 26 is locked in the guide element 23 and / or after the dispensing device 1 is assembled, preferably, the positioning device 31, the helical structure 31a, and / or the locking element 31b of the contact element 26 and the positioning device 31, the helical structure 31a, and / or the locking element 31b of the guide element 23 contact and / or abut against each other. In FIG. 6, the distance between the contact element 26 and the guide element 23 is shown for clarity purposes only.

[0206] Preferably, the positioning device 31, in particular the inclined plane or the helical structure 31a, and / or the locking element 31b define different discrete positions of the fixing element and / or the contact elements 25, 26 relative to the guide element 23. In other words, the positioning device 31, in particular the inclined plane or the helical structure 31a, and / or the locking element 31b can be used to fasten, in particular lock, the fixing element 25 and / or the contact element 26 on the guide element 23 at different discrete positions relative to the guide element 23. The proposed method for assembling the dispensing device 1 or for assembling the (plural) dispensing devices 1 will be specifically described below.

[0207] In particular, below, an assembly method in which the sealing elements 24 are present in batches will be described first. In this case, preferably, the variance regarding the critical dimensions of the sealing elements 24 is low within the batch. In this method, preferably, first, the assembly parameter M is determined using a random sample of a small number of sealing elements 24 of the batch, and then this assembly parameter M is used for each sealing element 24 during the installation of the sealing elements 24 of the batch later. In particular, the assembly parameter M is determined before or independently of the actual installation of the sealing elements 24 (for each batch). This method is specifically referred to as a batch method.

[0208] In yet another assembly method described below after the batch method, preferably, the assembly parameter M is determined individually or separately for each sealing element 24 to be installed, and the sealing element 24 is installed using this assembly parameter M. In particular, the installation or fixing of the sealing element 24 is carried out during or immediately after the determination of the assembly parameter M. In this method, the sealing elements 24 can be quite different from each other with respect to their important dimensions and / or can be from different batches. Nevertheless, this method is batch - available and can be applied to sealing elements 24 having low variations with respect to important dimensions. This method is particularly called an individual method.

[0209] However, first, the batch method will be discussed in more detail.

[0210] Preferably, the assembly parameter M is determined separately for each batch of the sealing elements 24. Below, after presenting an overview of the overall batch method, the procedure for determining the assembly parameter M will be described in more detail.

[0211] Preferably, a batch has a plurality of sealing elements 24, preferably more than 10,000, preferably more than 100,000, particularly more than 200,000, and / or less than 1,000,000, particularly less than 800,000 sealing elements 24.

[0212] Preferably, the assembly parameter M is determined using a random sample or subset of the batch of sealing elements 24.

[0213] In particular, the random sample has a small number of the sealing elements 24 in the batch, preferably at least 10, preferably at least 50, particularly at least 80, and / or at most 250, preferably at most 150, particularly at most 125 sealing elements 24. Preferably, the size of the random sample depends on the size of the batch, and particularly, a larger random sample is used for larger batches.

[0214] Preferably, the random sample has sealing elements 24 that are less than 50‰, preferably less than 20‰, particularly less than 10‰, particularly preferably less than 5‰, and very preferably less than 2‰ of the batch of sealing elements 24.

[0215] Preferably, the assembly parameter M or its value is determined in a test system (not shown) separately from the actual assembly of the sealing element 24 or the dispensing device 1.

[0216] Preferably, the receiving space 27 of the test system has the same dimensions as the receiving space 27 of the dispensing device 1. However, for the purpose of simplification, in the following, the above method will be described with reference to the receiving space 27 of the dispensing device 1.

[0217] Similarly, the contact element does not have to be the contact element 26 of the dispensing device 1 and can be formed by the test element of the test system. In this case, preferably, the test element is designed similarly or equivalently to the contact element 26.

[0218] Preferably, the test system does not have a complete dispensing device 1 and / or a complete pressure generator 5 and has only a receiving space 27 having the same dimensions as the receiving space 27 of the dispensing device 1 and / or the pressure generator 5. Preferably, the receiving space of the test system is also made of the same material as the receiving space 27 of the dispensing device 1.

[0219] It is not essential for the test system to have a guiding element that is structurally equivalent to the guiding element 23 of the dispensing device 1 (which has or forms the receiving space 27), nor is it essential to form the receiving space of the test system by a guiding element that is structurally equivalent to the guiding element 23 used in the dispensing device 1. Rather, what is important regarding the simulation of the dispensing device 1 and / or the simulation of the deformation of the sealing element 24 in the dispensing device 1 and / or the receiving space 27 is simply that the receiving space simulated within the test system corresponds as accurately as possible in terms of dimensions and / or material to the receiving space 27 of the dispensing device 1. Thus, as described above, preferably, the test element of the test system is designed similarly or equivalently to the contact element 26. Preferably, the test element is made of the same material as the contact element 26 and / or has the same diameter and / or cross-sectional area as the contact element 26 perpendicular to the axis A.

[0220] Furthermore, it is preferable for the test system to have a plunger 29 and / or a central element 30. Preferably, the conveying element 9 is simulated by the plunger 29 and / or the central element 30. It is preferable for the plunger 29 and / or the central element 30 to be made of the same material as the conveying element 9 and / or to have the same diameter and / or cross-sectional area as the conveying element 9 perpendicular to the axis A. The plunger 29 and the central element 30 will be described in more detail later.

[0221] In the test system, components of the dispensing device 1 and / or the pressure generator 5 that are not relevant to the sealing of the receiving space 27, for example, the discharge nozzle 12, or all parts that are not part of the pressure generator 5, are preferably omitted, and / or the test system does not have such components.

[0222] In this sense, the receiving space 27, and / or the pressure generator 5 and / or the dispensing device 1 are preferably simulated only within the test system.

[0223] In the batch method and / or the determination of the assembly parameter M for each batch, preferably, first, the assembly parameter M for all the sealing elements 24 of the random sample is determined in the manner described below. Preferably, next, an average value is found from the assembly parameter M determined separately for the sealing elements 24 of the random sample. In this case, preferably, this average value becomes a component of the assembly parameter M of the batch and is particularly used for each installation of the sealing element 24 of the batch.

[0224] Preferably, the assembly parameter M is selected or set such that at least a substantially same ratio between the volume of the receiving space 27 and the volume of the sealing element 24 in the receiving space 27, and / or the same deformation value of the sealing element 24 is provided for different batches of the sealing element 24. In other words, preferably, the assembly parameter M is selected such that the same deformation value or filling degree of the sealing element 24 in the receiving space 27 is provided each time the dispensing device 1 is assembled. The sealing and / or the sealing effect is determined by the deformation value and / or the filling degree such that a reliable seal can be achieved even if there are differences between different batches of the sealing element 24.

[0225] Preferably, the "equal" or "at least substantially the same" deformation value or filling degree is understood to mean a filling degree or a deformation value that differs only slightly from each other and / or is equivalent within the tolerance. Therefore, the same deformation value or filling degree does not exactly match or may deviate slightly from each other in this regard. In particular, two deformation values or filling degrees are the same as the case where they deviate by less than 10% from each other, preferably less than 5% from each other, particularly less than 2% from each other, and very preferably less than 1% from each other.

[0226] Preferably, the assembly parameter M is an adjustable and in particular geometric value that must be observed when the dispensing device 1 is assembled and / or that is met by the fully assembled dispensing device 1. Preferably, the assembly parameter M can be variably pre-specified in the configuration of the assembly process. Preferably, the assembly parameter M represents the relative position of the fixing element 25 and / or the contact element 26 with respect to the guiding element 23. Preferably, the assembly parameter M is a geometric parameter. In particular, the assembly parameter M or its value is the axial position of the fixing element 25 and / or the contact element 26. In other words, preferably, this position is defined by the assembly parameter M or its value. The position of the fixing element 25 and / or the contact element 26 preferably correlates with the volume of the receiving space 27 as described above and thus preferably also correlates with the deformation of the sealing element 24, so that the use or specification of the assembly parameter M (per batch) enables the reliable sealing of the conveying element 9 by the sealing elements 24 belonging to different batches of the sealing element 24 to be ensured in a simple manner.

[0227] For example, it is also possible that the assembly parameter M only indirectly corresponds to the position of the fixing element 25 and / or the contact element 26 by defining or forming the assembly parameter M by the distance of the path along which a part of the device used to assemble the dispensing device 1 and / or to fasten the fixing element 25 to the guiding element 23 moves.

[0228] In yet another example where the assembly parameter M only indirectly corresponds to the position of the fixing element 25 and / or the contact element 26, the assembly parameter M can be defined or formed by, for example, the rotation angle or the screw movement position of the component to be fastened, in particular fastened by a screw. In particular, when the fixing element 25 is designed as a nut or a cap nut as described above by way of example, the assembly parameter M can be formed by, for example, the rotation angle or the screw movement position. By specifying the rotation angle or the screw movement position, the edge position of the component or the nut can be defined and thus its axial position and / or the height of the receiving space 27 can be indirectly defined.

[0229] Preferably, different assembly parameters M or different values thereof correspond to different volumes of the receiving space 27 and / or different heights H of the receiving space 27. In other words, preferably, each assembly parameter M or each value thereof corresponds to a specific volume of the receiving space 27 or a specific height H of the receiving space 27.

[0230] However, instead of or in addition to this, the assembly parameter M can also correspond to a specific force for deforming and / or fixing the sealing element 24 fixed within the receiving space 27. Preferably, the volume of the receiving space 27 or the height H of the receiving space 27 can be directly correlated with a specific force or pressure for deforming the sealing element 24 within the receiving space 27 in each case. Therefore, instead of geometric parameters such as the position of the contact element 26 or the height H of the receiving space 27, a specific force can be used to define the assembly parameter M or can be used as the assembly parameter M. In particular, in this case, this force corresponds to a specific volume or a specific height H of the receiving space 27.

[0231] Preferably, the volume or height H of the receiving space 27 can be set or fixed using the assembly parameter M. In particular, the volume of the receiving space 27 can be adapted to each of the sealing elements 24 or each batch of the sealing elements 24, and different assembly parameters M, more precisely different values of the assembly parameter M, can be selected for different sealing elements 24 or different batches of the sealing elements 24 so that the same filling degree or the same sealing effect or seal is provided for different sealing elements 24 or different batches of the sealing elements 24.

[0232] Preferably, the assembly parameter M for the batch is first determined using a subset or random sample of the sealing elements 24 of the batch. Thereafter, preferably, each time the dispensing device 1 is assembled or each time a given batch of sealing elements 24 is fixed within the receiving space 27, a specific or selected assembly parameter M is used. In particular, the assembly parameter M is a value that can be set (only once) during the assembly of the dispensing device 1 and / or may not be measured or determined, and thus a plurality of dispensing devices 1 can be assembled quickly and efficiently, especially in an automated manner.

[0233] Preferably, the sealing element 24 or the dispensing device 1 is assembled in a process separate from the determination of the assembly parameter M and / or in a system different from the determination of the assembly parameter M.

[0234] Preferably, the sealing element 24 or the dispensing device 1 is assembled in a fully automated process. In this case, in particular, a large number of dispensing devices 1 are assembled at high speed. In particular, hundreds or thousands of dispensing devices 1 are assembled per hour.

[0235] For assembly, first the sealing element 24 is placed in the receiving space 27 of the dispensing device 1. Next, the fixing element 25 and / or the contact element 26 are inserted into the receiving space 27. As described above, the fixing element 25 and the contact element 26 can either be formed by different individual components from each other or constitute different parts of a single component. In the preferred embodiment also shown in the above-mentioned plurality of figures, the fixing element 25 and the contact element 26 are formed by two individual components. In this case, the contact element 26 is inserted into the receiving space 27.

[0236] Preferably, the fixing element 25 and / or the contact element 26 are moved into the receiving space 27 to such an extent that the sealing element 24 is deformed, in particular to such a depth that the deformation value of the sealing element 24 reaches or exceeds a threshold value. In particular, the previously determined assembly parameter M is used for this purpose, preferably determining how deep the fixing element 25 and / or the contact element 26 are moved into the receiving element 27, or at which position the fixing element 25 and / or the contact element 26, in particular the contact element 26, are to be fixed by the fixing element 25.

[0237] Preferably, the contact element 26 is moved to a desired position using a stamp or a plunger. The stamp or the plunger can be designed, for example, in a manner similar to the plunger 29 in principle, which will be described in more detail later with respect to the plunger 29, and is used to determine the assembly parameter M and is shown in FIGS. 4A to 4D. However, preferably, the stamp or the plunger used during assembly does not have a central element 30 and / or does not penetrate the contact element 26 and / or the sealing element 24 during assembly.

[0238] Preferably, the fixing element 25 is pushed over the contact element 26 and / or the guiding element 23 after the contact element 26 is arranged at a position corresponding to the assembly parameter M or determined by the assembly parameter M.

[0239] However, it is also possible that the fixing element 25 is already pushed over the contact element 26 and / or in contact with the contact element 26 when the contact element 26 is arranged so that the fixing element 25 and the contact element 26 are simultaneously moved in the direction of the sealing element 24. In this case, the contact element 26 is indirectly moved by the fixing element 25 in the direction of the sealing element 24. In this case, the stamp or the plunger for moving the fixing element 25 and the contact element 26 preferably contacts the fixing element 25 and acts on the contact element 26 only indirectly through the fixing element 25.

[0240] When the fixing element 25 and / or the contact element 26 reaches a desired position and / or a position defined by or corresponding to the assembly parameter M, the fixing element 25 is preferably fastened or fixed to the guiding element 23.

[0241] In addition to this, the fixing element 25 is preferably also fixed or fastened to the contact element 26.

[0242] "Fixing" the sealing element 24 means, in particular, fixing or clamping the sealing element 24 in the receiving space 27 so that it cannot move therein and / or cannot be undeformed, i.e., in particular, cannot return to its undeformed original shape. Preferably, this fixing or clamping is achieved by the fixing element 25 and optionally further by the contact element 26 clamping or fixing the sealing element 24 in the receiving space 27, and the fixing element 25 and / or the contact element 26 pressing the sealing element 24 so that it presses against the boundaries of the receiving space 27 over a large area on all sides or as deep as possible, in particular against the guiding element 23, the fixing element 25, and / or the contact element 26, thereby deforming the sealing element 24. In the fully assembled dispensing device 1, preferably, the sealing element 24 abuts against the conveying element 9 guided therethrough. The receiving space 27 and / or the guiding element 23, the fixing element 25 and / or the contact element 26, and preferably the conveying element 9 preferably define the boundary of the sealing element 24 or prevent further deformation of the sealing element 24 after assembly.

[0243] Accordingly, preferably, the sealing element 24 is fixed by fixing the contact element 26 to the guiding element 23 and / or fastening the fixing element 25 to the guiding element 23 and / or the contact element 26. Preferably, the height H and / or the volume of the receiving space 27 are defined and / or fixed or determined by fastening the fixing element 25 to the guiding element 23.

[0244] After the fixing element 25 and / or the contact element 26 are fixed, preferably, the conveying element 9 is installed. For this purpose, the conveying element 9 penetrates the fixing element 25 and is inserted into the channel 23b passing through the contact element 26 and / or the sealing element 24. However, in principle, the conveying element 9 can be installed or inserted before fixing the fixing element 25 and / or the contact element 26.

[0245] During the assembly of the dispensing device, preferably, the relative positions of the fixing element 25 and / or the contact element 26 with respect to the guiding element 23 can be specified or adjusted using the assembly parameter M. Preferably, distance measurement or height measurement is performed during assembly, and by these measurements, the height H of the receiving space 27, and / or in particular the relative positions of the fixing element 25 and / or the contact element 26 with respect to the receiving space 27 or its bottom surface 27a and / or the guiding part 23 can be verified and / or controlled directly or indirectly. In this case, preferably, all general path measurement methods, for example, tactile methods, optical methods, or inductive methods, etc. can be used.

[0246] In particular, by determining the assembly parameter M or its value in batches, it is not necessary to re-determine or re-adjust the assembly parameter M or its value every time the dispensing device 1 is assembled. The assembly parameter M or its value is preferably determined first for each batch (based on a subset or random sample of the sealing elements 24 of the batch), and then used for each sealing element 24 of this batch. As a result, the method of assembling the dispensing device 1 can be simplified and speeded up.

[0247] Next, the determination of the assembly parameter M will be described in more detail below with particular reference to FIGS. 4A to 4D and FIG. 5.

[0248] To determine the assembly parameter M, first each of the sealing elements 24 is placed in or disposed within the receiving space 27. Next, preferably, the fixing element 25 and / or the contact element 26 are placed on or brought into contact with the sealing element 24.

[0249] These are shown in FIGS. 4A to 4D. FIG. 4A shows a location where the contact element 26 has already been inserted into the receiving space 27 but is still not in contact with the sealing element 24. In FIG. 4B, the contact element 26 has been moved deep enough into the receiving space 27 to be in contact with the sealing element 24.

[0250] FIG. 4C shows the same situation as FIG. 4A. FIG. 4D shows the same situation as FIG. 4B. FIGS. 4C and 4D differ from FIGS. 4A and 4B only in that the sealing element 24 described in these figures has a smaller volume, a smaller diameter, or a smaller thickness D than the sealing element 24 described in FIGS. 4A and 4B.

[0251] Next, preferably, the sealing element 24 is deformed or pushed into the receiving space 27, in particular by the fixing element 25 and / or the contact element 26. These are done, in particular, by applying a force or pressure to the sealing element 24 by the fixing element 25 and / or the contact element 26. The deformation of the sealing element 24 by the contact element 26 for determining the assembly parameter M during the determination of the assembly parameter M is particularly shown in FIG. 4D.

[0252] Preferably, the sealing element 24 is deformed by a force acting axially on the sealing element 24 or by a pressure acting axially on the sealing element 24. However, in principle, instead of or in addition to this, a radial force can be used to deform the sealing element 24. Preferably, in this case, a radially inwardly acting force is used after the boundary of the receiving space 27 has been defined axially (i.e., in particular, after the fixing element 25 and / or the contact element 26 have been arranged on the receiving space 27).

[0253] The force or pressure is preferably exerted on the sealing element 24 and / or the sealing element 24 is preferably deformed by the plunger 29. In particular, the fixing element 25 and / or the contact element 26 come into contact with the sealing element 24 and are moved in the direction of the sealing element 24 or into the receiving space 27 by the plunger 29 so as to deform the sealing element 24 by exerting a force or pressure thereon. The plunger 29 is shown in FIGS. 4A to 4D.

[0254] The plunger 29 preferably acts only indirectly on the sealing element 24. Preferably, the plunger 29 acts or presses particularly axially on the fixing element 25 and / or the contact element 26. In particular, the plunger 29 is moved axially with respect to the fixing element 25 and / or the contact element 26 such that the fixing element 25 and / or the contact element 26 are moved axially in the direction of the sealing element 24, thereby deforming the sealing element 24.

[0255] The plunger 29 is preferably not part of the dispensing device 1 but is part of a test system in which the assembly parameter M is determined.

[0256] During or for the determination of the assembly parameter M, preferably, the central element 30 is guided into the channel 23b and / or through the (central) opening 24a of the sealing element 24. The volume of the receiving space 27 is preferably reduced or bounded by the central element 30. The central element 30 is shown in FIGS. 4A to 4D.

[0257] In particular, the central element 30 constitutes the inner radial boundary of the receiving space 27 during the correlation measurement and / or determination of the assembly parameter M.

[0258] Preferably, the central element 30 has the same diameter or the same outer dimension as the conveying element 9 in the radial direction.

[0259] Preferably, the central element 30 is part of the plunger 29 or is formed as a single piece having the plunger 29. However, the central element 30 can be formed separately from the plunger 29 and / or can form an individual component.

[0260] When the central element 30 is pushed axially, at least one part of the central element 30 is tapered, conical, and / or rounded such that the radial spread or width B of the receiving space 27 defined by the central element 30 is reduced. In this way, the insertion of the central element 30 into the channel 23b and / or through the opening 24a of the sealing element 24 can be facilitated and / or damage to the sealing element 24 can be prevented.

[0261] In principle, the central element 30 can be formed by the conveying element 9.

[0262] During the measurement or determination of the correlation of the assembly parameter M, the sealing element 24 is preferably pressed against the central element 30 and is deformed in particular in this process.

[0263] After the determination of the assembly parameter M, preferably the central element 30 is removed again from the channel 23b or the opening 24a of the sealing element 24.

[0264] Preferably, the assembly parameter M is selected such that when the sealing element 24 is fixed, the deformation value corresponding to the deformation of the sealing element 24 reaches or exceeds a threshold value.

[0265] The deformation value that "exceeds" the threshold value is understood to mean the situation where the deformation value is first smaller than the threshold value and then reaches a value larger than the threshold value, and vice versa, i.e., the situation where the deformation value is first larger than the threshold value and then reaches a value smaller than the threshold value.

[0266] A plurality of threshold values can be specified. Preferably, the assembly parameter M is selected such that the deformation value falls between these threshold values. Thus, in particular, these threshold values can represent the maximum and minimum values for the deformation value.

[0267] The deformation value preferably corresponds to the deformation and / or compression of the sealing element 24. In other words, preferably, the deformation value is a value or measure of how much and / or how the sealing element 24 is deformed and / or compressed. As will be explained in more detail below, the deformation value is preferably determined indirectly using an eigenvalue.

[0268] The deformation of the sealing element 24 is schematically shown in FIGS. 5B and 5C.

[0269] FIG. 5B shows the undeformed sealing element 24, particularly before it is placed in the receiving space 27. In the example of FIG. 5B, the sealing element 24 has a circular cross-section with a diameter or thickness D. However, in principle, the sealing element 24 or its cross-section can be of any shape.

[0270] FIG. 5C shows the deformed sealing element 24. In particular, the view of FIG. 5C corresponds to the sealing element 24 inserted and fixed within the fully assembled dispensing device 1 and / or its receiving space 27. As can be seen from FIG. 5C, the sealing element 24 is deformed compared to the initial situation of FIG. 5B, and in particular its outer shape is adapted to the shape of the receiving space 27.

[0271] When the sealing element 24 is deformed, initially preferably an elastic deformation occurs, in which the volume of the sealing element 24 does not (significantly) change, or only the outer shape of the sealing element 24 is changed or adapted to the receiving space 27. Generally, following a simple shape change, the action of pressure and / or force, and / or a further increase in the deformation of the sealing element 24, in particular in addition to the mainly pure shape change, a volume compression of the sealing element 24, i.e., a change or reduction in volume, begins.

[0272] Particularly preferably, the threshold value corresponds to the deformation value corresponding to the start of this volume compression of the sealing element 24, or the deformation value at which volume compression begins or starts. However, depending on the material of the sealing element 24, it may be desirable or advantageous to select as the threshold value a value that specifically exceeds or falls below the value at which volume compression begins. For example, for materials with high creep behavior, such as thermoplastic elastomers (TPE), it can be advantageous to set a threshold value such that volume compression still does not begin.

[0273] Preferably, the assembly parameter M is determined based on the deformation behavior and / or frictional behavior of the sealing element 24 during the deformation of the sealing element 24 in the receiving space 27.

[0274] The inspection or determination of the deformation behavior and / or frictional behavior will be explained in more detail below with reference to FIGS. 4A to 4D and FIG. 5.

[0275] To inspect or determine the deformation behavior, preferably, a (growing) force is applied to the sealing element 24 by the plunger 29, the fixing element 25, and / or the contact element 26, thereby deforming the sealing element 24. In particular, for a plurality of different deformations or deformation values of the sealing element 24, the force required to achieve such a deformation or deformation value is determined in each case. Preferably, the displacement corresponding to this force is also determined.

[0276] To inspect or determine the frictional behavior, the boundary of the receiving space 27, in particular the central element 30 and the sealing element 24, are preferably moved relative to each other, and at several points during the deformation in each case, the frictional force between the sealing element 24 and the boundary is determined.

[0277] Preferably, the deformation value is determined at least indirectly by or during the inspection or determination of the deformation behavior and / or frictional behavior of the sealing element 24. However, the deformation value itself may not need to be determined directly or be known. For example, a specific deformation value corresponding to the force and / or frictional force between the sealing element 24 and the boundary required for this determination can be known from past tests.

[0278] The eigenvalue is preferably measured to inspect the deformation behavior and / or the frictional behavior. In particular, conclusions regarding the deformation value can be drawn from the eigenvalue, or the deformation value can be determined. In other words, preferably, the eigenvalue is a variable or value determined or measured to determine, calculate, and / or derive the deformation value therefrom. The eigenvalue is preferably correlated with the deformation value. Accordingly, a specific deformation value preferably corresponds to each value of the eigenvalue.

[0279] Preferably, the eigenvalue is the force and / or pressure acting on the sealing element 24 for the purpose of deformation, and / or the position of the plunger 29 used to deform the sealing element 24, in particular the axial position. In other words, preferably, the force and / or pressure for deforming the sealing element 24 is measured, and / or the position of the plunger 29 for deforming the sealing element 24 is measured. In particular, this force can be indirectly known from the position of the plunger 29. As a result, a desired deformation value for different sealing elements 24, or a reliable seal and / or sealing effect can be achieved as a result.

[0280] In each case, this force is preferably associated with a specific area, in particular the area of the receiving space 27 and / or the bottom surface 27a. In this regard, this force directly corresponds to the pressure in each case or is normalized or associated with the area in each case. The term "force" is also preferably interchangeable with the term "pressure".

[0281] Preferably, the deformation behavior is determined using the force or pressure acting on the sealing element 24 towards deformation. Instead of or in addition to this, the deformation behavior is determined (indirectly) using the position of the plunger 29, and / or the fixed element and / or the contact elements 25, 26, in particular the axial position. The position of the plunger 29, and / or the fixed element and / or the contact elements 25, 26, in particular the height H of the receiving space 27.

[0282] In particular, the height H of the receiving space 27 or a variable correlated therewith, for example, the plunger 29, and / or the movement path or axial position of the fixed element and / or the contact elements 25, 26 can be specified or set, and the corresponding force can be determined or measured. However, contrary to this principle, it is also possible to specify or set a force and determine or measure the height H of the receiving space 27 corresponding to or correlated with the particular force set or specified in each case.

[0283] The force, pressure, and / or position of the plunger 29 are preferably measured. However, the force, pressure, and / or position can also be known, pre-specified, or made computable or determinable without using a clear measured value from a magnitude such as a control parameter used to move the plunger 29, for example, an (electrical) voltage that controls or adjusts the force exerted by the plunger 29.

[0284] Instead of or in addition to determining the deformation behavior of the sealing element 24 during deformation, as described above, it is possible to determine the frictional behavior while the sealing element 24 is being deformed. The deformation of the sealing element 24 in the receiving space 27 can be measured (indirectly) by measuring an auxiliary measurement variable, for example, the frictional force that occurs between the sealing element 24 and the boundary of the receiving space 27 that contacts and moves relative to it. The frictional force increases when the contact pressure of the sealing element 24 against the boundary increases, and the increase in the frictional force depends on the deformation occurring within the sealing element 24 and / or the size of the contact surface between the sealing element 24 and the boundary of the receiving space 27. In particular, the contact pressure increases with an increase in the deformation of the sealing element 24, which results in a change, especially an increase, in the frictional force between the sealing element 24 and the boundary of the receiving space 27. First, at least mainly elastic deformation of the sealing element 24 occurs. This elastic deformation gradually changes to compression of the sealing element 24 when the deformation increases. In particular, the increase and / or gradient of the frictional force is greater when the sealing element 24 is compressed than when it undergoes elastic deformation. Therefore, conclusions can be drawn regarding the deformation or deformation behavior of the sealing element 24 through the frictional behavior, and in particular, the deformation or deformation behavior of the sealing element 24 can be determined (indirectly).

[0285] To determine the frictional behavior, preferably, the sealing element 24 is moved relative to the boundary of the receiving space 27. This movement can be performed, for example, by moving the plunger 29 or the central element 30 relative to the sealing element 24, especially in the axial direction or along the axis A. In this case, the central element 30 forms the boundary of the receiving space 27, and this boundary is moved relative to the sealing element 24. In this case, the plunger 29 or the central element 30 is preferably moved reciprocally or back and forth. In particular, the force required to move the plunger 29 or the central element 30 is measured. This force measurement preferably corresponds to or is correlated with the frictional force between the plunger 29 or the central element 30 and the sealing element 24. The characteristic value as an (especially indirect) axial measurement preferably represents the force measurement and / or the frictional force. From these, the deformation value and thus especially the threshold value are also determined, calculated, or derived.

[0286] In this method, preferably, the fixed element 25 and / or the contact element 26 are fixed, moved, or pressed into the receiving space 27 using yet another plunger (not shown in FIGS. 4A to 4D).

[0287] However, in principle, this frictional force can also be measured in another way, for example, by rotating the plunger 29 or the central element 30 relative to the sealing element 24 and / or around the axis A and measuring the resulting torsional friction or torsional frictional force.

[0288] The advantage of determining the frictional behavior during the deformation of the sealing element 24 is that the long-term behavior of the sealing element 24 in the dispensing device 1 can be predicted by a short-term test, namely, by measuring the frictional force.

[0289] Another advantage of determining the frictional behavior during the deformation of the sealing element 24 is that the threshold value and / or the assembly parameter M are directly determined using a parameter or eigenvalue that has an effect on the properties of the aerosol 14 generated using the dispensing device 1, namely, the frictional force. The greater the frictional force between the sealing element 24 and the conveying element 9 that occurs when the conveying element 9 is moved to generate the aerosol 14, the more a part of the total available energy is lost due to friction, so the energy available for generating the aerosol 14 from the fluid is less. Therefore, excessive frictional force means that the droplets of the generated aerosol 14 have a more uneven and / or smaller size and / or the duration of the spray burst is affected, especially shortened. These things have an adverse effect on the effect and accurate dosing of the medicine sprayed as the aerosol 14 using the dispensing device 1.

[0290] In particular, a force / displacement curve is recorded to inspect or determine the deformation behavior or frictional behavior and / or to determine the assembly parameter M. The assembly parameter M is very preferably determined using the profile of the force / displacement curve.

[0291] Figure 5A shows the force / displacement curve. In this figure, the displacement is plotted on the x-axis and the force F is plotted on the y-axis.

[0292] In Figure 5A, the displacement is represented by the height H of the receiving space 27. However, this displacement can also correspond to the travel distance or position of the plunger 29 used to deform the sealing element 24 and / or the fixed element and / or contact elements 25, 26. This displacement can be known from being measured or by any other method, for example, a control parameter such as a voltage used to control or adjust the travel distance of the plunger 29 and / or the fixed element and / or contact elements 25, 26. In particular, a specific value of the displacement or height H corresponds to a specific volume of the receiving space 27.

[0293] The force F is, for example, the above-mentioned force acting on the sealing element 24 for the purpose of deformation or a variable corresponding thereto, such as the acting pressure, and / or the frictional force generated during the relative movement between the sealing element 24 and the boundary of the receiving space 27 or the central element 30.

[0294] Preferably, a specific deformation or deformation value of the sealing element 24 corresponds to a specific force required to achieve this deformation or this deformation value, and / or a specific height H of the receiving space 27 or a variable correlated thereto when this deformation or deformation value is reached. Therefore, in particular, the deformation value can be determined by the force and / or the height H.

[0295] Figure 5A shows two different forces F1, F2, as well as the associated displacements and / or heights H1, H2. Preferably, the displacement or height H is correlated with the travel distance and / or position of the plunger 29 used to deform the sealing element 24.

[0296] In the following, FIG. 5A will be described "from right to left", i.e., starting with a large value of H. The force / displacement curve starts with a value D for the height H, where D is the axial height of the undeformed sealing element 24, in particular the axial height and / or cross-sectional height of the ring-shaped sealing element 24, and particularly preferably the thickness of the doughnut-shaped sealing element 24, as shown, for example, in FIG. 5B. At this point, the fixing element 25 and / or the contact element 26 still contact the undeformed sealing element 24, as shown, for example, in FIG. 4B. At this point, no deformation has yet occurred and / or no force has been applied to the sealing element 24, so the force F has a zero value.

[0297] For the deformation or (elastic) deformation of the sealing element 24, initially, preferably, only a small amount of force is required. As shown in FIG. 5A, when the deformation increases, the force initially increases slightly. This can be seen from the very slight increase in the force F from the point H = D to the point H = H1. For lower values of H and the corresponding axial movement path of the plunger 29 in the direction of the sealing element 24 and / or the receiving space 27, the volume of the receiving space 27 is reduced, and accordingly the sealing element 24 is pressed deeper or more firmly into the receiving space 27, thereby being deformed. Therefore, the lower value of H in this case corresponds to a greater deformation of the sealing element 24.

[0298] Due to the elasticity of the sealing element 24, the force required for purely shape change or deformation is relatively small.

[0299] When the height H decreases, the volume of the receiving space 27 decreases, and thus the filling degree, i.e., the ratio of the volume of the sealing element 24 to the receiving space 27, decreases.

[0300] The force F increases as the height H decreases and / or the volume of the receiving space 27 decreases.

[0301] In particular, when the height H continues to decrease, the compression of the sealing element 24 begins as described above. Once the compression begins, a greater force is required than for the pure shape change to compress the sealing element 24, so the gradient of the force / displacement curve becomes particularly large.

[0302] Thus, in particular, it is possible to read or determine the deformation, in particular the start of compression, from the force / displacement curve and / or its profile, in particular its gradient and / or curvature.

[0303] In particular, the gradient and / or curvature of the force / displacement curve changes when the volume compression of the sealing element 24 begins. In the example shown in FIG. 5A, this change occurs in particular between positions H1 and H2 shown in the drawing and / or between values F1 and F2. When the height H is further reduced, the volume compression occurs greatly or predominantly. This volume compression requires a strong force, and thus reaches a strong force F within the left-hand region of FIG. 5A, and the force / displacement curve has a strong gradient or increases steeply (towards smaller values of H).

[0304] The start of volume compression preferably corresponds to the strongest curvature of the force / displacement curve. When the volume compression begins, the force / displacement curve can have an inflection point or the like. Thus, in particular, the start of volume compression can be determined reliably and accurately by deriving the force / displacement curve, for example, by deriving a force / displacement curve having a discontinuity or other sharp change in the profile when the volume compression begins.

[0305] To determine the assembly parameter M, preferably, the point in time when the volume compression of the sealing element 24 begins is determined or established using the force / displacement curve, and / or a specific eigenvalue K corresponding to the start of the volume compression of the sealing element 24 and / or at the start of the volume compression is determined.

[0306] In other words, the specific eigenvalue K is, in particular, the value of the eigenvalue when the volume compression of the sealing element 24 begins.

[0307] From the above description, volume compression begins, in particular, at the point where the force / displacement curve has the strongest curvature and / or inflection point. Thus, preferably, a particular eigenvalue K corresponds to the force at the time when the force / displacement curve has (at least substantially) the strongest curvature and / or inflection point, and further in the example of FIG. 5A correlates with the desired or preferred height HM in the assembly, and further this height HM correlates with the desired assembly parameter M.

[0308] Different force / displacement curve profiles are provided for different sealing elements 24 or batches thereof, and thus different particular eigenvalues K, heights HM, and / or assembly parameters M may be provided.

[0309] Preferably, the assembly parameter M is selected or determined to correspond to the start of volume compression of the sealing element 24. Thus, from the above description, preferably, the assembly parameter M is selected such that the height of the receiving space 27 in the fully assembled dispensing device 1 at least substantially corresponds to the height HM when the force / displacement curve has the strongest curvature and / or inflection point. In particular, this assembly parameter M corresponds to the height HM of the receiving space 27 when the volume of the (deformed) sealing element 24 corresponds to the volume of the receiving space 27, or when at least substantially 100% filling is reached.

[0310] However, it is possible to select or determine an assembly parameter M corresponding to different deformations or deformation values of the sealing element 24, for example, when volume compression has not yet started, or when the sealing element 24 has not yet been compressed, and / or when the sealing element 24 has only undergone elastic deformation or at least mainly elastic deformation. Preferably, a defined difference can be selected between the deformation value corresponding to the assembly parameter M and the deformation value corresponding to the start of volume compression. Similarly, it is possible to select or determine an assembly parameter M corresponding to the deformation or deformation value of the sealing element 24 when volume compression has already started and / or when the sealing element 24 has already been compressed.

[0311] Accordingly, the assembly parameter M can also correspond to other filling degrees, or filling degrees other than 100%, for example, higher than 95% and / or lower than 105% (either). Depending on the material of the sealing element 24, these filling degrees may be more advantageous than the 100% filling degree or achieve good sealing and / or service life.

[0312] Preferably, for each batch, a random sample is used to determine the conditions under which the deformation value reaches or exceeds a desired threshold value, and / or specific characteristic values at that time, in particular the force in the force / displacement curve. Next, the assembly parameter M is selected such that the deformation value reaches or exceeds the threshold value when the sealing element 24 of the batch is installed. Accordingly, the assembly parameter M corresponds in particular to the corresponding height HM and / or specific characteristic value K. Preferably, the selection of the assembly parameter M is such that the same volume of the receiving space 27 is provided at or through the position where the fixing element 25 is fastened to the guiding element 23, and / or the deformation value corresponds to the threshold value when the assembly parameter M is determined by the deformation of the plunger 29, and / or the contact element 26 is fixed at the position where it is located, and / or the deformation value is assumed to be the threshold value. In other words, preferably, the assembly parameter M is selected such that the height (and thus in particular the volume) of the receiving space 27 of the fully assembled dispensing device 1 has the same value as the travel path or height HM corresponding to the specific characteristic value K in the force / displacement curve.

[0313] In determining and / or during the determination of the assembly parameter M, the deformation value corresponding to the selected or determined assembly parameter M is preferably exceeded. For example, the value F2 shown in FIG. 5A can be the maximum force acting on the sealing element 24 when the assembly parameter M is determined, and the assembly parameter M shown in FIG. 5A can be the selected or determined assembly parameter M. Accordingly, preferably, the determination of the assembly parameter M proceeds along the force / displacement curve until it is greater than the height H corresponding to the assembly parameter M. In particular, this is because the highest curvature or gradient can only be reliably determined after exceeding the point of its strongest curvature or gradient.

[0314] In the batch method described so far, as described above, first, the assembly parameter M for the batch of the sealing element 24 is determined in a separate process, in particular using random samples, and then it is used during the assembly of the sealing element 24 of this batch.

[0315] However, the separation between the stage of determining the assembly parameter M and the actual assembly of the dispensing device 1 is not essential.

[0316] In yet another aspect described below that can also be carried out independently, the present invention further relates to a method of assembling a dispensing device 1 that first determines the assembly parameter M for the sealing element 24, immediately fixes the sealing element 24 in the receiving space 27 immediately after this determination, and / or assembles the dispensing device 1 by carrying out the assembly of the dispensing device 1 immediately after this determination. In this case, in contrast to the batch method described above, the sealing element 24 is also fixed in the dispensing device 1 or the receiving space 27 for which the assembly parameter M has been determined. In particular, the determination of the assembly parameter M and the assembly of the dispensing device 1 are carried out successively immediately and / or within the same system. This method is particularly referred to as an individual method.

[0317] The individual method is particularly advantageous during assembly, in particular, automatic or continuous assembly of the dispensing device 1 is to be carried out without prior determination of the assembly parameter M. The individual method can particularly be the case where the batch of sealing elements 24 or their important dimensions deviate significantly from each other. In this case, a common assembly parameter M cannot be determined for all the sealing elements 24 of the batch, and / or it may not be possible to guarantee a reliable seal and / or sealing effect by determining a single assembly parameter M for all the sealing elements 24 of the batch.

[0318] Nevertheless, in principle, the individual method described in more detail below can also be used when the sealing elements 24 are present in a batch and the sealing elements 24 of the batch deviate only slightly from each other, and thus it is considered that the batch method can be used in principle.

[0319] In the individual method, preferably, the assembly parameter M is at least substantially similar to that described above with respect to FIGS. 4A-4E and FIG. 5 for the batch method, in particular, determined based on the deformation behavior and / or frictional behavior of the sealing element 24 during deformation in the receiving space 27, and / or the profile of the force / displacement curve.

[0320] Therefore, the above description regarding the determination of the assembly parameter M preferably also applies to the individual method.

[0321] In contrast to the plunger 29 shown in FIGS. 4A-4D used in the batch method, in the individual method, the plunger 29 preferably does not have a central element 30 and / or does not penetrate the contact element 26 and / or the sealing element 24.

[0322] However, preferably, instead of the central element 30, the conveying element 9 is already guided through the contact element 26 and / or the sealing element 24 and / or inserted into the channel 23b during the determination of the assembly parameter M. In this sense, the central element 30 is preferably replaced by the conveying element 9. Therefore, preferably, the above description regarding the central element 30 also applies to the method of using the conveying element 9 instead of the central element 30.

[0323] As described above for the batch method, in the individual method as well, the sealing element 24 is deformed to determine the assembly parameter M, and when the assembly parameter M is determined, it is greater than the desired deformation of the sealing element 24 or the desired deformation value of the sealing element 24.

[0324] Therefore, after the determination or completion of the assembly parameter M, preferably, the plunger, and thus the fixing element 25 and / or the contact element 26, are slightly retracted, i.e., retracted in a direction away from the sealing element 24. Thereby, in particular, the fixing element 25 and / or the contact element 26 are arranged such that this assembly parameter M is implemented and / or the position of the fixing element 25 and / or the contact element 26 corresponds to this specific assembly parameter M. As a result, the sealing element 24 takes on a desired deformation value and / or a desired deformation value is implemented.

[0325] Next, preferably, the fixing element 25 and / or the contact element 26 or the sealing element 24 are fixed in this position, in particular, by fixing or fastening the fixing element 25 to the guiding element 23 or the guiding portion 23a and / or to the contact element 26. Preferably, the fixing element 25 is fastened, for example, by crimping as described above.

[0326] In particular, in the case of an individual method, the fixing or assembly of the sealing element 24 or the dispensing device 1 is carried out immediately after the determination of the assembly parameter M and / or within the same system as the determination of the assembly parameter M.

[0327] In contrast to the batch method, in the individual method, the fixing element 25 is preferably incorporated during the determination of the assembly parameter M. In the batch method, as shown, in the embodiment of the fixing element 25 and the contact element 26 as individual parts, preferably, only the contact element 26 is inserted into the receiving space 27 and / or the sealing element 24 is deformed only by the contact element 26. In contrast, in the case of the individual method, preferably, the fixing element 25 is incorporated when the deformation of the assembly parameter M and / or the sealing element 24 is determined using the contact element 26, and thus, immediately after the assembly parameter M is determined and / or the contact element 26 and / or the fixing element 25 are correctly arranged, the fixing element 25 can be fixed in this position or fastened to the guiding element 23.

[0328] "Drug" within the scope of the meaning of the present invention is intended to be a substance or its preparation that has properties suitable for use in or on the body of a human or animal and that can cure, alleviate, or prevent a human or animal disease or pathological condition, or a substance or its preparation that can be applied or administered to the body of a human or animal for the purpose of restoring, correcting, or influencing physiological functions by means of pharmacological effects, immunological effects, or metabolic effects, or for the purpose of performing a medical diagnosis.

[0329] "Assembly parameter" within the scope of the meaning of the present invention is preferably an adjustable value and / or geometric value that is pre-specified and / or must be observed during the assembly of the dispensing device, or that can be executed or implemented on the fully assembled dispensing device. Preferably, the assembly parameter can be pre-specified in a variable manner in the configuration of the assembly process. Preferably, the assembly parameter is a geometric parameter, particularly preferably the relative position or linear dimension of components, for example, the height of the receiving space of the dispensing device. In particular, the assembly parameter is the position of the fixing element relative to the guiding element when the sealing element is fixed within the guiding element and / or in its receiving space using the fixing element. In other words, this position is preferably determined by the assembly parameter or its value. Similarly, it is also possible for the assembly parameter to correspond only indirectly to the position of the fixing element and / or the contact element, for example, by defining or forming the assembly parameter by means of a displacement path such as when a part of the device moves to assemble the dispensing device and / or to fasten the fixing element to the guiding element.

[0330] Preferably, the "deformation value" within the scope of the present invention is a measure of how severely the sealing element is deformed, particularly compressed. In particular, the deformation value is a value corresponding to the deformation of the sealing element or indicates the deformation of the sealing element. The deformation value can be determined, calculated, and / or derived from, for example, one or more measured values or characteristic values. Preferably, the deformation value indicates whether and / or to what extent the sealing element is (elastically) deformed and / or compressed. In particular, the deformation value cannot be directly measured or determined, but is preferably a (temporary) characteristic or temporary state of the sealing element determined, calculated, or derived from measured characteristic values.

[0331] Preferably, the "threshold value" within the scope of the present invention is a value or limit value used to select or determine assembly parameters. The threshold value is particularly a specific value or limit value of the deformation value. Preferably, the assembly parameters are selected or determined such that the deformation value reaches or exceeds the threshold value when the sealing element is fixed. Preferably, the threshold value can be pre-specified or can be made so. Preferably, the threshold value corresponds to the start of the volumetric compression of the sealing element and / or is the value of the deformation value when the volumetric compression of the sealing element begins. However, depending on the material of the sealing element, it may be desirable or advantageous to select as the threshold value a value that particularly exceeds or is below the value at which the volumetric compression begins.

[0332] Preferably, the "characteristic value" within the scope of the present invention is a value determined or measured to determine, calculate, and / or derive the deformation value from this value. The characteristic value can be, for example, a force (particularly pressure or frictional force), pressure, or position that is particularly measured. Thus, in particular, the characteristic value is a measured value that enables conclusions to be drawn regarding the deformation value.

[0333] Preferably, the "compression set" within the meaning of the present invention is a material property of the material making up the sealing element. In particular, the compression set is a measure of how this material, especially an elastomer, behaves during long-term non-temporary and / or steady-state compression deformation and preferably during subsequent relaxation. Preferably, the compression set is determined in accordance with DIN ISO 815-1:2016-09. To determine the compression set, preferably, a cylindrical test piece is compressed by especially 25% and stored at a specific temperature for a specific period. After removal of the load, preferably, 30 minutes after removal of the load, the permanent deformation of the test piece is determined from a comparison between the height of the test piece before compression and the height of the test piece after removal of the load. In particular, 0% compression set means that the test piece has completely regained its original height. 100% compression set means that this test body has completely deformed during the test and shown no recovery. In particular, the compression set is the ratio (L0-L2) / (L0-L1) when L0 is the height of the test piece before the test, L1 is the height of the test piece during the test, and L2 is the height of the test piece after the test.

[0334] The "creep behavior" or "creep" of a material or a sealing element within the meaning of the present invention is, in particular, the behavior of the material or the sealing element under a constant load. In particular, the creep behavior or creep is a time-dependent and / or temperature-dependent plastic deformation under a constant load. The creep behavior or creep is determined or characterized in particular by the creep modulus.

[0335] The "fixing" of a sealing element into a receiving space within the meaning of the present invention is, in particular, the fixing or securing of the sealing element into the receiving space such that the sealing element within the receiving space no longer undergoes or cannot undergo any further deformation.

[0336] The above-described aspects and features can be implemented independently of each other, but can also be implemented in various combinations. In particular, the batch method and the individual method can be combined with each other. In other words, the steps described with respect to the batch method can also constitute the steps of the individual method, and vice versa.

[0337] List of reference signs 1 Dispensing device 2 Drug 3 Container 4 Fluid space 5 Pressure generator 6 Holder 7 Driving spring 8 Locking element 8a Trigger button 9 Conveying element 10 Check valve 11 Pressure chamber 12 Discharge nozzle 13 Mouthpiece 14 Aerosol 15 Air supply opening 16 (Upper) housing part 17 Inner part 17a Upper part (inner part) 17b Lower part (inner part) 18 (Lower) housing part 19 Retaining element 20 Spring 21 Container bottom surface 22 Penetrating element 23 Guide element 23a Fastening part 23b Channel 23c Recess 24 Sealing element 24a Opening 25 Fixing element 25a Opposing surface 26 Contact element 26a Contact part 26b Stop 26c Insertion part 27 Receiving space 27a Bottom surface 28 Supply channel 29 Plunger 30 Central element 31 Positioning device 31a Spiral structure 31b Locking element A Axis B Width D Thickness F Force K Specific eigenvalue H Height HM Height suitable for assembly M Assembly parameter

Claims

1. A method of assembling a dispensing device (1) for dispensing a drug (2), comprising the steps of: placing a sealing element (24) in a receiving space (27) of the dispensing device (1); or placing a sealing element (24) in a receiving space (27) in a test system having the same dimensions as the receiving space (27) of the dispensing device (1); the sealing element (24) arranged in the receiving space (27) is deformed and an assembly parameter (M) is determined during the deformation based on a deformation behavior and / or a friction behavior of the sealing element (24) during the deformation in the receiving space (27), said sealing element (24) or a different sealing element (24) to be installed is fixed in the receiving space (27) of the dispensing device (1) using said assembly parameters (M), A method comprising:

2. The dispensing device (1) to be assembled comprises: a delivery element (9) movable to deliver said drug (2); a guide element (23) for guiding said conveying element (9); a sealing element (24) for sealing the conveying element (9) against the guide element (23); a fixing element (25) or a contact element (26) fastened to the guide element (23), the guiding element (23) at least partially defines the boundary of the receiving space (27) of the dispensing device (1) for receiving the sealing element (24), the sealing element (24) being fixed in the receiving space (27) by means of a fixing element (25) or a contact element (26), The method of claim 1.

3. The method described in claim 1 or claim 2, wherein the sealing element (24) is ring-shaped.

4. 4. The method according to claim 1, wherein a plurality of sealing elements (24) are provided in batches, and an assembly parameter (M) is determined separately for each batch using a random sample of the sealing elements (24) of a given batch, and the assembly parameter (M) determined for this batch is used for each fixation of the sealing elements (24) of the batch in the receiving space (27).

5. 5. The method according to claim 4, characterized in that the assembly parameters (M) are selected in each case such that the same deformation value of the sealing element (24) is produced for fully assembled dispensing devices (1) for different batches of sealing elements (24).

6. The method according to claim 5, characterized in that the deformation value is a measure of how much the sealing element (24) is deformed or compressed.

7. 7. The method according to claim 4, wherein to determine the assembly parameter (M) of a batch, an assembly parameter (M) is first determined separately for each sealing element (24) in the random sample, and an average value of these separately determined assembly parameters (M) is defined as the assembly parameter (M) for all sealing elements (24) of the batch.

8. 8. The method according to claim 4, characterized in that, for determining the assembly parameter (M), a central element (30) is guided through an opening (24a) in the sealing element (24) and / or through the receiving space (27), the volume of which is reduced or delimited by said central element (30).

9. the number of sealing elements (24) in the random sample is less than 50% of the number of sealing elements (24) in the batch; and / or the volume of the sealing element (24) of a batch deviates from the average volume of the sealing element (24) of the batch by less than 10%; 9. The method according to any one of claims 4 to 8.

10. The method described in claim 9, characterized in that the number of sealing elements (24) in the random sample is less than 20‰ of the number of sealing elements (24) in the batch.

11. The method described in claim 9, characterized in that the number of sealing elements (24) in the random sample is less than 10‰ of the number of sealing elements (24) in the batch.

12. The method described in claim 9, characterized in that the number of sealing elements (24) in the random sample is less than 5‰ of the number of sealing elements (24) in the batch.

13. The method described in claim 9, characterized in that the number of sealing elements (24) in the random sample is less than 2‰ of the number of sealing elements (24) in the batch.

14. The method according to claim 9, characterized in that the deviation of the volume of the sealing elements (24) of a batch from the average volume of the sealing elements (24) of the batch is less than 5%.

15. The method of claim 9, wherein the deviation of the volume of the sealing elements (24) of a batch from the average volume of the sealing elements (24) of the batch is less than 4%.

16. 2. The method according to claim 1, characterized in that the sealing element (24) is permanently fixed in the receiving space (27) immediately after the deformation and the determination of the assembly parameters (M) by means of a fixing element (25) or a contact element (26) acting on the sealing element (24).

17. 17. The method according to claim 1 or 16, characterized in that the assembly parameter (M) is determined separately for each sealing element (24) to be installed, the assembly parameter (M) being used in each case only when fixing the sealing element (24) for which the assembly parameter (M) was determined.

18. the assembly parameters (M) are adjustable and / or geometrical values ​​that are pre-specified and / or implemented for the assembly of the dispensing device (1); 18. The method according to any one of claims 1 to 17.

19. The method according to claim 18, characterized in that the assembly parameters (M) can be pre-specified in a variable manner in the configuration of the assembly process.

20. 20. The method according to any one of claims 1 to 19, characterized in that the assembly parameter (M) is a position of a fixing element (25) or a contact element (26) relative to the receiving space (27) and / or to a guide element (23) of the dispensing device (1), or the position of the fixing element (25) or the contact element (26) relative to the receiving space (27) and / or to the guide element (23) of the dispensing device (1) is determined by the assembly parameter (M).

21. The method according to claim 20, wherein the position is the axial position of the fixing element (25) or the contact element (26) relative to the receiving space (27) and / or the guide element (23).

22. A method as described in claim 20 or claim 21, characterized in that the guide element (23) at least partially defines the boundary of the receiving space (27) and the fixing element (25) or contact element (26) is used to fix the sealing element (24) in the receiving space (27).

23. 23. The method according to any one of claims 1 to 22, characterized in that the assembly parameter (M) corresponds to a volume of the receiving space (27) and / or to a deformation value at the start of a volumetric compression of the sealing element (24).

24. 24. The method according to claim 1, wherein the assembly parameter (M) is selected or determined in such a way that a deformation value corresponding to a deformation of the sealing element (24) when the sealing element (24) is fixed in the receiving space (27) reaches or exceeds a threshold value, the threshold value corresponding to the onset of volumetric compression of the sealing element (24).

25. 25. The method according to claim 1, wherein in order to determine the deformation behavior and / or friction behavior of each of the sealing elements (24) having different deformations, characteristic values ​​are measured in each case which correspond to the deformation values ​​of the sealing elements (24) and / or from which the deformation values ​​of the sealing elements (24) can be calculated, determined and / or derived.

26. 26. The method of claim 25, wherein the characteristic value is a force, a pressure, or a position.

27. The method of claim 26, wherein the eigenvalue is a frictional force or a compressive force.

28. 28. Method according to any one of the preceding claims, characterized in that, in order to determine the deformation behaviour of each of the sealing elements (24), the force required for deformation is determined in each case for different deformations.

29. 29. The method according to claim 1, wherein, to determine the friction behavior of each of the sealing elements (24), the sealing element (24) and the boundary of the receiving space (27) are moved relative to each other and the friction force between the sealing element (24) and the boundary is determined in each case for different deformations.

30. 30. The method according to any one of the preceding claims, characterized in that force / displacement curves are recorded in order to determine the deformation or friction behaviour and / or to determine the assembly parameter (M).

31. The method of claim 30, wherein the assembly parameter (M) is determined based on a profile and / or curvature of the force / displacement curve.

32. 32. The method according to any one of claims 1 to 31, characterized in that the sealing element (24) is designed to seal a conveying element (9) for conveying the drug (2) against a guide element (23) which comprises or forms the receiving space (27) and in which the conveying element (9) is guided.

33. a delivery element (9) that can be moved to deliver the drug (2); a guide element (23) for guiding said conveying element (9); a sealing element (24) for sealing the conveying element (9) against the guide element (23); a fixing element (25) or a contact element (26) fastened to the guide element (23), A dispensing device (1) for dispensing a drug (2), wherein the guide element (23) at least partially defines the boundary of a receiving space (27) for receiving the sealing element (24), and the sealing element (24) is fixed in the receiving space (27) by means of the fixing element (25) or the contact element (26), the guide element (23), the fixing element (25) and / or the contact element (26) have geometries that define different discrete positions for fastening the fixing element (25) and / or the contact element (26) to the guide element (23), said sealing element (24) is fixed using these discrete positions and with assembly parameters (M) determined during deformation based on the deformation behavior and / or friction behavior of said sealing element (24) during said deformation before fixing; A dispensing device (1) characterized in that

34. The dispensing device according to claim 33, characterized in that the fixing and / or contact elements (25, 26) can be locked on the guide element (23) in different discrete positions, the different discrete positions being different axial positions of the fixing and / or contact elements (25, 26) relative to the guide element (23).

35. A dispensing device as claimed in claim 33 or 34, characterized in that the fixing and / or contact elements (25, 26) and / or the guide element (23) have a positioning device (31) for positioning the fixing and / or contact elements (25, 26) relative to the guide element (23).

36. Dispensing device according to claim 35, characterized in that the positioning device (31) comprises or is formed by one or more locking elements (31b).

37. Dispensing device according to claim 35 or 36, characterized in that the positioning device (31) has or is formed by an inclined plane or a helical structure (31a).

38. A dispensing device according to any one of claims 35 to 37, characterized in that the positioning device (31) is arranged on an end face of the fixing and / or contact elements (25, 26) and / or on an end face of the guiding element (23).

39. A dispensing device as described in any one of claims 33 to 38, characterized in that the rotational position of the fixing and / or contact elements (25, 26) relative to the guide element (23) or the dispensing device (1) determines the axial position of the fixing and / or contact elements (25, 26).

40. A dispensing device according to any one of claims 33 to 39, characterized in that the positions of the fixing and / or contact elements (25, 26) are determined such that the deformation of the sealing element (24) and / or the size of the receiving space (27) can be changed by changing the position of the fixing element (25) or contact element (26).

41. A dispensing device according to any one of claims 33 to 40, characterized in that the fixing and / or contact element (25, 26) can be moved into the receiving space (27) to different degrees before it is fixed in the desired position.

42. Dispensing device according to any one of claims 33 to 41, characterized in that the sealing element (24) is a sealing ring and / or a separate component which can be inserted into the receiving space (27).

43. A dispensing device as described in Claim 42, characterized in that the sealing element (24) is made of an elastic material having an elastic modulus less than 100 MPa.

44. A dispensing device as described in Claim 42, characterized in that the sealing element (24) is made of an elastic material having an elastic modulus less than 50 MPa.

45. A dispensing device as described in Claim 42, characterized in that the sealing element (24) is made of an elastic material having an elastic modulus less than 10 MPa.

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