Method for assembling dispensing devices, and dispensing device

Abstract

The invention relates to a method for assembling dispensing devices for dispensing a medicament, wherein, for assembly purposes, a sealing element is fixed in a receiving space of the dispensing device with a specific assembly parameter. Preferably, a plurality of sealing elements are produced in batches and all sealing elements in a batch are fixed with the same assembly parameter. The invention also relates to a dispensing device for dispensing a medicament.

Description

[0001] Method for assembling dispensing devices and dispensing device

[0002] The present invention relates to a method for assembling dispensing devices for dispensing a medicinal product according to the preamble of claim 1 and to a dispensing device for dispensing a medicinal product according to the preamble of claim 19.

[0003] The present invention relates in particular to the arrangement or assembly of a sealing element in a receiving chamber of the dispensing device associated with the sealing element. The sealing element preferably serves to seal a conveying element for dispensing a medicinal product from a container of the dispensing device. The sealing element then rests against the conveying element in a sealing manner in the fully assembled dispensing device. The conveying element is preferably movable relative to the sealing element. In particular, the conveying element is moved relative to the sealing element to dispense the medicinal product.

[0004] Several requirements must be met when sealing the conveying element with the sealing element. On the one hand, a reliable seal must be ensured even during long storage or service life of the dispensing device. In other words, a permanent and reliable "static seal" of the conveying element by the sealing element should be achieved. On the other hand, a reliable seal must be ensured during use of the dispensing device, especially when the conveying element moves relative to the sealing element; that is, a so-called "dynamic seal" should be achieved.

[0005] The desired seal, both in the static case where the sealing element is stationary relative to the conveying element, and in the dynamic case where the conveying element is moving relative to the sealing element, may present different, even conflicting, requirements. A particularly good static seal can be achieved by ensuring that the sealing element has the largest possible contact area and / or is firmly in contact with the conveying element. However, this is disadvantageous for dynamic sealing, as a large and firm contact area of ​​the sealing element with the conveying element can lead to increased abrasion or damage to the sealing element, as well as increased force required when moving the conveying element relative to the sealing element, or even to slower movement of the conveying element. Furthermore, for a good static seal, the sealing of the conveying element by the sealing element should be as diffusion-tight as possible.Diffusion through the sealing element should therefore be prevented or at least minimized.

[0006] WO 2004 / 053362 A1 concerns a piston pump system with a piston guided in a guide tube, which can perform a flub movement along its longitudinal axis. An O-ring seal, held in a groove within the guide tube, seals the piston. It was recognized that a good seal can be achieved by optimally adjusting the fill level of the seal in the groove. The "fill level" corresponds to the quotient of the volume of the (undeformed) seal and the volume of the groove. It is proposed to use a fill level of more than 90%, i.e., to employ a sufficiently voluminous sealing ring.

[0007] A method for achieving a reliable seal of a conveying element in a dispensing device is known, for example, from WO 2007 / 051536 A1 and US 2007 / 0282276 A1. It was recognized that the sealing elements are subject to certain manufacturing tolerances, which cause the sealing elements of different batches to differ in size, making a reliable seal problematic. To overcome this problem, a sealing element size corresponding to a specific volume is determined for each batch. Each batch of sealing elements is assigned to a specific group of components in the dispensing device, where each component forms a groove-shaped receiving space for the sealing element, and the different groups of components differ in the size of this receiving space.Each batch of sealing elements is then combined with a specific group of components of the dispensing device, so that a desired fill level and thus a good seal is achieved by the sealing element.

[0008] The aforementioned method requires increased storage space for the different batches of sealing elements and the various groups of components. Furthermore, the method is not flexible enough to be used with different sealing materials. It is an object of the present invention to provide a simple and flexible solution for the reliable and permanent sealing of a conveying element of a dispensing device for delivering a medicinal product. This object is achieved by a method according to claim 1 or a dispensing device according to claim 19. Advantageous embodiments are the subject of the dependent claims.

[0009] As proposed, a sealing element is installed in a discharge chamber of a discharge device with a previously determined assembly parameter.

[0010] The assembly parameter can be determined individually for each sealing element or by random sampling for a batch of sealing elements. The determination of the assembly parameter can be carried out either in a receiving chamber of the dispensing device or, particularly in the case of random sampling, in a test facility. Preferably, the test facility has a receiving chamber that has the same dimensions as the receiving chamber of the dispensing device.

[0011] In particular, the present invention relates to a method for assembling dispensing devices for dispensing a medicinal product and to a dispensing device for dispensing a medicinal product, wherein a sealing element with the specified assembly parameter is arranged and fixed in the receiving space of the dispensing device.

[0012] Preferably, the sealing element arranged in the receiving space of a dispensing device or test system is deformed, and the assembly parameters are determined based on the deformation behavior and / or friction behavior of the sealing element during the deformation.

[0013] After determining the assembly parameter, the sealing element or another sealing element to be mounted is fixed in the receiving space of a dispensing device using the assembly parameter.

[0014] The dispensing device that is assembled, or in which the sealing element is fixed, can be the same dispensing device in which, or in whose receiving space, the sealing element was positioned to determine the assembly parameter. However, it is also possible that the dispensing device that is assembled, or in which the sealing element is fixed, is a different dispensing device, a different instance of the same dispensing device, or has a different instance of the same receiving space than the dispensing device or receiving space used to determine the assembly parameter. This is particularly the case with the batch process described in more detail below.

[0015] By determining the assembly parameter based on the deformation and / or friction behavior, or by using the assembly parameter, manufacturing tolerances as well as size and / or material differences of sealing elements can be easily taken into account or compensated for, thus ensuring a reliable seal or sealing effect. This contributes to consistent quality in the production or assembly of a large number of dispensing devices, especially in an automated process.

[0016] The assembly parameter is preferably an adjustable, particularly geometric, value that must be adhered to during the assembly of the dispensing device and / or is realized in the fully assembled dispensing device. Preferably, the assembly parameter can be variably predefined in the settings of an assembly sequence. Preferably, the assembly parameter is a geometric parameter, in particular a, preferably relative, position of a component or a dimension, such as a dimension of the receiving space of the dispensing device. In particular, the assembly parameter is a position of a fixing element relative to a guide element, wherein the sealing element is fixed in the guide element or a receiving space of the guide element by means of the fixing element.

[0017] Preferably, several sealing elements are available in batches. For each batch, a mounting parameter is preferably determined separately using a sample of sealing elements from that batch. This mounting parameter, determined for the batch, is preferably used each time a sealing element from that batch is fixed in a receiving space.

[0018] Preferably, the determination of the assembly parameter for a batch is carried out separately or independently, in particular temporally and / or spatially, from the assembly of sealing elements or dispensing devices, preferably in a different system than the assembly of sealing elements or dispensing devices. In other words, the determination of the assembly parameter and the assembly of dispensing devices are preferably carried out separately from each other. This method is hereinafter also referred to as the "batch method". The assembly parameter is preferably selected such that, in fully assembled dispensing devices for different batches or regardless of the batch, the same deformation value of the sealing element in the receiving space results. The deformation value is, in particular, a measure of how much the sealing element is deformed, especially compressed.This allows manufacturing tolerances as well as size and / or material differences of sealing elements to be easily taken into account or compensated for, thus ensuring a reliable seal. This contributes to consistent quality in the manufacture and assembly of numerous dispensing devices, especially in automated processes.

[0019] The deformation value is preferably set during assembly by means of a fixing element or contact element, particularly an axial one, which deforms the sealing element. In particular, a specific deformation value of the sealing element is thus achieved by means of the assembly parameter.

[0020] Preferably, to determine the assembly parameter for a batch, an assembly parameter is first determined separately for each sealing element in the sample, and an average value of these separately determined assembly parameters is then set as the assembly parameter for all sealing elements in the batch. In other words, the assembly parameter determined for a batch is preferably an average value of several assembly parameters. This allows manufacturing tolerances as well as size and / or material differences of sealing elements to be easily taken into account or compensated for, and ensures a reliable seal. This promotes consistent quality in the manufacture or assembly of a large number of dispensing devices, especially in an automated process.

[0021] When determining the assembly parameter, a central element is preferably guided through an opening in the sealing element, whereby the volume of the receiving space is reduced or limited by the central element. This facilitates assembly and ensures consistent quality in the manufacture or assembly of a large number of dispensing devices, particularly in an automated process.

[0022] 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. Using the central element offers the advantage that the deformation of the sealing element during the determination of the assembly parameter corresponds to the deformation the sealing element exhibits in the fully assembled dispensing device, without requiring the conveying element to be mounted at the time of determining the assembly parameter. Therefore, using the central element facilitates a simple and reliable determination of the assembly parameter and / or ensures a reliable seal. Furthermore, using the central element allows the assembly parameter to be determined independently of the assembly of the sealing element, or even before the assembly of the sealing element, and / or in a different system than the assembly of the sealing element.This facilitates an optimal process for determining the assembly parameter and / or assembling the sealing element, particularly in an automated process. It is preferred that the diameter of the central element corresponds to the diameter of a conveying element of the dispensing device, which is designed for conveying pharmaceuticals, especially from a container of the dispensing device, and / or which is associated with or connected to a discharge device of the dispensing device for generating an aerosol. This promotes a reliable seal.

[0023] The number of sealing elements in the sample is preferably less than 50‰, more preferably less than 20‰, particularly less than 10‰, most preferably less than 5‰, and most preferably less than 2‰, of the number of sealing elements in the batch. This allows for minimal effort in determining the assembly parameter or a quick and efficient determination of the assembly parameter.

[0024] Alternatively or additionally, the volumes of the sealing elements in a batch preferably deviate by less than 10%, particularly less than 5%, and most preferably less than 4%, from the target volume or average volume of the sealing elements in the batch. This promotes consistent quality in the production or assembly of a large number of dispensing devices, especially in an automated process.

[0025] The features described above referred in particular to a process hereinafter also referred to as a "batch process", in which the sealing elements are manufactured or available in batches and an assembly parameter is first determined for each batch on the basis of a sample, whereby this assembly parameter is later used for the assembly of each sealing element of the batch.

[0026] However, it is also possible to first determine the assembly parameter for each sealing element during assembly and then, particularly immediately after determining the assembly parameter, to fix the sealing element in the receiving space using this parameter. This is particularly relevant regardless of whether the sealing elements are available or manufactured in batches and / or whether the individual sealing elements differ significantly from one another. The method described below, which will also be referred to as the "individual method," is therefore particularly advantageous when individual sealing elements differ significantly from one another, but can also be implemented for any sealing elements, including those that are very similar within a single batch.

[0027] In the individual process, in which the sealing element arranged in the receiving space is preferably also deformed and an assembly parameter is determined during the deformation as described above, the sealing element is fixed in the receiving space immediately after deformation and determination of the assembly parameter by means of a fixing element or contact element acting on the sealing element. This allows manufacturing tolerances as well as size and / or material differences of sealing elements to be easily taken into account or compensated for, and ensures a reliable seal or sealing effect. This contributes to consistent quality in the manufacture or assembly of a large number of dispensing devices, especially in an automated process.In the individual process, where the sealing element is fixed in the receiving space immediately after deformation and determination of the assembly parameter, the assembly parameter is preferably determined separately for each sealing element to be mounted and used only for fixing the sealing element for which it was determined. This is advantageous for ensuring a reliable seal or sealing effect with sealing elements that differ significantly from one another.

[0028] The aspects explained in more detail below preferably apply both to the method in which the assembly parameters for all sealing elements of a batch are first determined using a sample and the assembly (using the assembly parameter) is carried out separately from the determination of the assembly parameter (batch method), and to the method in which an assembly parameter is determined separately for each sealing element and the sealing element is fixed in the receiving space immediately after the determination of the assembly parameter using this assembly parameter (individual method). It is preferred that the assembly parameter represents, or corresponds to, a position, in particular an axial position, of a fixing element and / or contact element relative to a guide element of a dispensing device, or that the (relative) position of the fixing element and / or contact element is defined or determined by the assembly parameter.The guide element preferably includes or at least partially forms the receiving space. Furthermore, the receiving space is preferably limited by the fixing element or attachment element.

[0029] Preferably, the fixing element or mounting element is designed to fix the sealing element in the receiving space, or the fixing element or mounting element fixes the sealing element in the receiving space. Particularly preferably, the mounting element is arranged, or can be arranged, between the sealing element and the fixing element, with the mounting element directly contacting the sealing element and fixing it in the receiving space. The mounting element is preferably fixed, or can be fixed, by means of the fixing element. In particular, the mounting element is thus directly fixed by means of the fixing element, and the sealing element is thereby indirectly fixed in the receiving space. Alternatively, the mounting element can also be formed integrally with the fixing element. This allows manufacturing tolerances as well as size and / or material differences of sealing elements to be easily taken into account or compensated for, and a reliable seal or sealing effect to be ensured.This promotes consistent quality in the manufacture and assembly of numerous dispensing devices, particularly in automated processes. Different assembly parameters preferably correspond to different volumes of the receiving chamber or to different differences between the volumes of the sealing element and the receiving chamber. The assembly parameter thus allows the volume of the receiving chamber to be adjusted or varied, compensating for manufacturing tolerances as well as size and / or material differences of sealing elements and / or the receiving chamber. This ensures reliable sealing and consistent quality in the production of numerous dispensing devices, especially in automated processes.

[0030] The assembly parameter is preferably selected or determined such that, when the sealing element is fixed, a deformation value corresponding to the deformation of the sealing element reaches or exceeds a threshold value. Different threshold values ​​are preferably provided for different sealing elements that differ, for example, in their external shape and / or the material from which they are made. The threshold value is preferably predetermined or predefinable. In this way, a reliable seal and thus consistent quality can be achieved simply in the production of a large number of dispensing devices. Furthermore, the method is adaptable to different sealing elements and therefore flexibly replaceable.

[0031] The deformation value is preferably a measure of the degree to which the sealing element is deformed. When the sealing element is deformed in the receiving space, particularly annular space, for example by a plunger, an initial, preferably elastic, deformation of the sealing element preferably occurs. During this deformation, the volume of the sealing element preferably remains at least approximately constant, and at least substantially only the external geometric shape of the sealing element changes. During this deformation of the sealing element, its shape adapts to the shape of the receiving space and increasingly fills it. This continues until the sealing element at least approximately completely fills the receiving space and / or its shape at least approximately corresponds to the shape of the receiving space. If the sealing element continues to deform, the deformation value is then reduced.When the sealing element is compressed or pressed within the receiving space, volume compression of the sealing element preferably occurs. In volume compression, unlike (elastic) deformation, the volume of the sealing element decreases.

[0032] In summary, the behavior of the sealing element during deformation in the receiving space can be divided, at least approximately, into two phases, whereby in the first phase deformation essentially occurs at constant volume, while in the second phase volume compression occurs.

[0033] Of course, it is not impossible that a (slight) volume compression may already begin towards the end of the first phase or during the deformation.

[0034] The aforementioned threshold value, or threshold value for the deformation value—that is, the threshold value used to determine or select the assembly parameter—preferably corresponds to the onset of volume compression of the sealing element. In other words, the threshold value is preferably the deformation value at which volume compression of the sealing element begins. This ensures a reliable seal and sealing effect. Furthermore, excessive wear and abrasion are avoided. This contributes to consistent quality during the manufacturing and assembly of numerous dispensing devices, particularly in an automated process. The sealing element is preferably deformed by moving a plunger and / or the contact element or fixing element relative to the sealing element. The plunger can act on the contact element or fixing element, thereby indirectly affecting the contact element or fixing element.Move the fixing element relative to the sealing element, thereby deforming the sealing element over the contact or fixing element. However, it is also possible to directly act on the sealing element with the plunger, thus deforming the sealing element.

[0035] The movement of the plunger and / or contact element or fixing element relative to the sealing element preferably occurs in an axial and / or radial direction. In particular, the sealing element is arranged in the receiving space such that the force or pressure exerted on the sealing element by means of the plunger and / or contact element or fixing element results in a deformation and / or compression of the sealing element in the receiving space.

[0036] To determine or investigate the deformation behavior of a given sealing element, the force required for deformation (directly or indirectly) is determined, 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, represents a characteristic value from which the deformation value can be determined, calculated, or derived. Alternatively, the force causing the deformation can be specified, and the deformation or the corresponding feed or axial position of the plunger and / or contact element or fixing element, or in particular the dimensions of the receiving space, can be determined, and in particular measured.

[0037] Alternatively or additionally to determining or investigating the deformation behavior of the sealing element, the friction behavior of the sealing element can also be determined or investigated, as already mentioned. To determine or investigate the friction behavior of the respective sealing element, a boundary of the receiving space and the sealing element are preferably moved relative to each other, and the frictional force between the sealing element and the boundary is determined, in particular measured, at different deformations or deformation values ​​of the sealing element. The measured force preferably represents the characteristic value from which the deformation value can be determined, calculated, or derived. Preferably, the boundary of the receiving space, which is moved relative to the sealing element, is the aforementioned central element, which is guided through the receiving space or the receptacle of the sealing element during the determination of the assembly parameter.In this case, the central element or the boundary is preferably moved axially relative to the sealing element, particularly in an oscillatory or Flin-and-Fler motion. However, it is also possible for the sealing element to be rotated relative to the receiving space or the boundary, especially the central element. In this case, the frictional force between the sealing element and the boundary is preferably a torsional friction force. Accordingly, the characteristic value or the force measured to determine the deformation value is also preferably a torsional friction force. At different times during the deformation, the sealing element is preferably deformed to varying degrees within the receiving space. These different times therefore preferably correspond to different feed rates or positions of the fixing element or contact element.

[0038] In particular, a force-displacement curve is recorded to determine the deformation behavior and / or friction behavior and / or to determine the assembly parameter. Preferably, the assembly parameter is determined based on the shape of the force-displacement curve. This facilitates a simple, quick, and / or accurate determination of the assembly parameter.

[0039] The force in the force-displacement curve is preferably the force applied to deform the sealing element and / or the frictional force between the sealing element and the boundary of the receiving space moving relative to the sealing element.

[0040] The path in the force-displacement curve is preferably the advance of the plunger, fixing element, or attachment element, or the fleas of the receiving chamber, or a corresponding path. The sealing element is preferably designed to seal a conveying element for conveying the drug against a guide element that includes or forms the receiving chamber, in which the conveying element is guided.

[0041] Preferably, the sealing element is ring-shaped or a molded seal or a sealing ring, in particular an O-ring.

[0042] The sealing element is preferably a separate component that can be replaced within the receiving space. Preferably, the sealing element consists of an elastic material. An elastic material within the meaning of the invention is preferably a material with a modulus of elasticity of less than 100 MPa, preferably less than 50 MPa, and particularly less than 10 MPa.

[0043] Sealing elements from different batches can be made of different materials and / or exhibit different deformation properties, compression set, and / or different creep behavior or creep moduli. The process, in which a separate assembly parameter is determined for each batch, ensures a reliable seal for even these different sealing elements or batches. In particular, the precise adjustment of the receiving chamber volume possible with this process allows the use of materials for sealing elements that are semi-plastic or exhibit comparatively high creep, such as thermoplastic elastomers (TPE). Such sealing elements require receiving chambers that are precisely designed or adapted to the specific sealing element.According to a further aspect, which can also be implemented independently, the present invention relates to a dispensing device for delivering a medicinal product. The dispensing device comprises a conveying element, in particular axially movable, for conveying the medicinal product from a container of the dispensing device, a guide element for guiding the conveying element, and a sealing element, in particular annular, for arrangement in a receiving chamber of the guide element. The sealing element is preferably designed to seal the conveying element against the guide element and is particularly designed as a sealing ring. Furthermore, the sealing element is preferably fixable in the receiving chamber by means of a fixing element or contact element that can be attached to the guide element. Preferably, the guide element forms the pressure chamber of a piston pump, or the guide element comprises the pressure chamber, with the conveying element forming the piston of the piston pump.

[0044] The fixing element or mounting element can preferably be attached to the guide element in various axial positions relative to the guide element. This makes it possible and intended that the sealing element is fixed with a specific, adapted mounting parameter. In this way, manufacturing tolerances as well as size and / or material differences of sealing elements can be easily taken into account or compensated for, and a reliable seal or sealing effect can be ensured. This contributes to consistent quality in the manufacture or assembly of a large number of dispensing devices, especially in an automated process.

[0045] Preferably, the fixing or positioning element can be locked onto the guide element in various axial positions relative to the guide element. This facilitates the correct or desired positioning of the fixing or positioning element and thus contributes to simple and error-free assembly. This promotes consistent quality in the manufacture or assembly of a large number of dispensing devices, especially in an automated process.

[0046] Alternatively or additionally, the fixing or positioning element and / or the guide element preferably has a positioning device for positioning the fixing or positioning element relative to the guide element. The positioning device particularly preferably has or is formed by one or more detent elements, especially detent cams. This facilitates the assembly or fixing of the position of the fixing or positioning element. This allows manufacturing tolerances of sealing elements to be easily taken into account or compensated for, and ensures a reliable seal or sealing effect. This contributes to consistent quality in the manufacture or assembly of a large number of dispensing devices, especially in an automated process.

[0047] The positioning device preferably has or is formed by an inclined plane or helical structure. This facilitates easy adjustment of the position of the fixing or positioning element relative to the guide element. The positioning device is preferably arranged on the end face of the fixing or positioning element and / or the guide element.

[0048] It is preferred that the rotational position of the fixing or positioning element, particularly relative to the guide element or dispensing device, determines the axial position of the fixing or positioning element. In particular, the positioning device is designed accordingly.

[0049] Preferably, the position of the fixing or mounting element relative to the guide element defines a specific deformation or deformation value of the sealing element and / or a size or volume of the receiving space, such that the deformation of the sealing element and / or the size or volume of the receiving space can be varied or adapted to each other by varying the position of the fixing element. The aforementioned and subsequent aspects and features of the present invention can be combined with one another in different combinations, but can also be implemented independently of one another. Further aspects, features, advantages, and properties of the present invention will become apparent from the claims and the following description of preferred embodiments with reference to the drawing. The drawing shows:

[0050] Fig. 1 shows a schematic section of a dispensing device according to the invention in a first state;

[0051] Fig. 2 shows a schematic section of the dispensing device in a second state, rotated by 90° relative to Fig. 1;

[0052] Fig. 3 shows a schematic section through a pressure generator of the dispensing device; Fig. 4A shows a schematic section through the pressure generator during a first situation when determining the assembly parameter;

[0053] Fig. 4B shows a schematic section through the pressure generator during a second situation when determining the assembly parameter;

[0054] Fig. 4C shows a schematic section through the pressure generator according to Fig. 4A during the first situation when determining the assembly parameter, wherein the sealing element has a different size than in Fig. 4A;

[0055] Fig. 4D shows a schematic section through the pressure generator according to Fig. 4C during the second situation when determining the assembly parameter; Fig. 4E shows a schematic section through the pressure generator after fixing the sealing element;

[0056] Fig. 5A shows a schematic representation of the course of a measured value during a deformation or determination of an assembly parameter;

[0057] Fig. 5B shows a schematic section through an undeformed sealing element; Fig. 5C shows a schematic section through a deformed sealing element; and

[0058] Fig. 6 shows a schematic side view of the printing unit according to a further embodiment.

[0059] In the figures, which are partly not to scale and only schematic, the same reference symbols are used for identical or similar parts, whereby corresponding or comparable properties and advantages can be achieved, even if a repeated description is omitted for the sake of clarity.

[0060] Figures 1 and 2 show a proposed dispensing device 1 for dispensing a medicinal product 2. In particular, the dispensing device 1 is designed as an atomizer or for atomizing the medicinal product 2. The medicinal product 2 is preferably a fluid, especially a liquid.

[0061] Fig. 1 shows the dispensing device 1 in a schematic section in a first state, here in the not ready-to-trigger state, and Fig. 2 in a second state, here in the ready-to-trigger state.

[0062] The dispensing device 1 is preferably designed as a portable, portable and / or mobile dispensing device 1.

[0063] When the drug 2 is atomized by means of the dispensing device 1, an aerosol 14 is preferably formed, in particular wherein the aerosol 14 can be inhaled by a user (not shown). The dispensing device 1 is therefore preferably designed as an inhaler.

[0064] Inhalation is usually performed at least once a day, and in particular several times a day, preferably at predetermined intervals, for example depending on the patient's condition.

[0065] The aerosol 14 is preferably a particle-air mixture containing solid and / or liquid particles, which are particularly preferably respirable, i.e., in particular, at least partially or on average smaller than 5 pm in diameter. The dispensing device 1 is preferably propellant-free, i.e., preferably operates without propellant. Instead, the dispensing device 1 preferably operates with a mechanical pressure generator 5 or mechanism for generating the aerosol 14. In particular, this is a mechanically operated pump that pressurizes the drug substance 2, thereby generating the aerosol 14 when it is discharged from a dispensing nozzle 12. However, the dispensing device 1 can also be driven or operate in other, preferably mechanical, ways. The dispensing device 1 has a preferably removable and preferably replaceable container 3 containing the substance or drug substance 2.The container 3 preferably forms a reservoir for the drug 2 to be atomized.

[0066] Preferably, the container 3 contains a sufficient quantity of the medicinal product 2 to provide, for example, up to 200 dosing units, thus enabling up to 200 atomizations or applications. A typical container 3, as disclosed in WO 96 / 06011 A2 or WO 00 / 49988 A2, has a volume of approximately 2 ml to 10 ml. The container 3 is preferably at least substantially cylindrical or cartridge-shaped. In the illustrated example, it can be inserted into the dispensing device 1 from below after opening it and may be replaceable. However, it may also be non-replaceable, and the dispensing device 1 may be a disposable product.

[0067] The container 3 is preferably at least substantially rigid. The container 3 is particularly preferably made of plastic, in particular thermoplastic plastic, most preferably polypropylene. Preferably, the container 3 has a flat surface on its bottom or a flat container bottom 21.

[0068] Preferably, the medicinal product 2 is contained in a fluid chamber 4 formed by a collapsible bag within the container 3. The dispensing device 1 preferably also includes a pressure generator 5, preferably mechanical, for conveying and atomizing the medicinal product 2, in particular in a predetermined, optionally adjustable, dosage quantity. The pressure generator 5 preferably forms a high-precision pump or metering pump, in particular a piston pump.

[0069] The pressure generator 5 preferably has a drive spring 7 for driving the pressure generator 5 (only partially shown in the illustration). The drive spring 7 is preferably designed to store energy, particularly mechanically, and release it to the pressure generator 5, so that the pressure generator 5 pressurizes the drug substance 2, thereby forming the aerosol 14 from the drug substance 2 as it is dispensed from the dispensing nozzle 12. The pressure generator 5 is thus driven by the drive spring 7 or by the energy provided by the drive spring 7.

[0070] The pressure generator 5 preferably has a holder 6 for the container 3, the associated drive unit, shown only partially, in particular in the form of the drive spring 7, as well as a conveying element 9, in particular a tubular one, a check valve 10 and / or a pump or pressure chamber 11.

[0071] Preferably, the dispensing device 1 has a locking mechanism or locking element 8, which is designed to lock the drive spring 7, preferably automatically, after energy has been introduced into the drive spring 7. The energy is preferably introduced into the drive spring 7 by stretching, extending, compressing, or, in particular, compressing the drive spring 7. For the sake of simplicity, this is referred to below as "tensioning" the drive spring 7, and the resulting state of the drive spring 7 is described as "tensioned" (regardless of whether the specific drive spring in the respective embodiment was stretched or compressed for this purpose). Preferably, after tensioning or compression, the drive spring 7 is locked in a state of higher energy by the locking element 8, which can be operated manually.held in a charged or tensioned state, whereby the energy stored in the drive spring 7 - in particular by tensioning - is released or used for pressure generation in the print generator 5 by actuating the locking element 8 (directly or preferably via a release button 8a).

[0072] Preferably, the drive spring 7 is a spiral or helical spring, wherein energy is stored or supplied by means of axial compression of the drive spring 7. Preferably, the dispensing device 1 or the pressure generator 5 has a discharge nozzle 12, particularly in the area of ​​an optional mouthpiece 13.

[0073] The container 3 is preferably fixed in the dispensing device 1 via the holder 6, in particular by means of a locking mechanism, or fluidically connected to the conveying element 9, such that the conveying element 9 is immersed in the container 3. The holder 6 can be designed such that the container 3 can be detached and replaced.

[0074] When energy is applied to the drive spring 7, or when the drive spring 7 is tensioned, the holder 6 with the container 3 and the conveying element 9 is moved downwards in the illustrations (that is, in the illustrated example, the drive spring 7 is axially compressed), and the drug 2 is drawn from the container 3 through the check valve 10 into the pressure chamber 11 of the pressure generator 5. During the subsequent discharge or relaxation of the drive spring 7 after activation by actuating the locking element 8, the drug 2 in the pressure chamber 11 is pressurized. This occurs because the conveying element 9, with its now closed check valve 10, is moved upwards again by the drive spring 7, or back into the pressure chamber 11, acting as a pressure piston. This pressure forces the drug 2 out through the discharge nozzle 12, where it is atomized into the aerosol 14, as indicated in Fig. 1.

[0075] If the conveying element 9 or the check valve 10 functions as a pressure piston, a movement of the conveying element 9 or of the container 3 corresponds to a volume displaced in the pressure chamber 11 or to a quantity of drug discharged or dischargeable.

[0076] A user or patient (not shown) can inhale the atomized drug 2 or the aerosol 14, preferably with air being drawn into the mouthpiece 13 via at least one optional air inlet 15.

[0077] In the illustrated example, the dispensing device 1 preferably comprises an upper housing part 16 and an inner part 17 (inner housing part) (see Fig. 2) rotatable relative to it, with an upper part 17a and a lower part 17b (see Fig. 1). A lower housing part (lower housing part) 18 or a cap, preferably detachably or permanently attached to the inner part 17 by means of a retaining element 19, is preferably manually operable or rotatable, in particular by means of a snap-on fitting.

[0078] For inserting and / or replacing the container 3, the lower housing part 18 is preferably detachable from the dispensing device 1. However, the container 3 can also be non-replaceable.

[0079] The lower housing part 18 can be rotated against the upper housing part 16 or twisted relative to the upper housing part 16, preferably taking with it the lower part 17b of the inner part 17 shown in the illustration.

[0080] In particular, the lower housing part 18 is arranged to prevent rotation on the inner part 17, preferably by means of a positive locking connection. The inner part 17 can thus be rotated against the housing part 16 or twisted relative to the housing part 16 by means of the lower housing part 18. However, other solutions are also possible.

[0081] By rotating the upper housing part 16 relative to the lower housing part 18 or the inner part 17, the drive spring 7 is axially compressed, in particular compressed, via a gear mechanism (not shown) acting on the holder 6. During this compression, the container 3 is preferably moved axially downwards until it reaches an end position indicated in Fig. 2. In this state, the drive spring 7 is compressed, and the dispensing device 1 is ready for dispensing. During the atomization process, the drive spring 7 preferably returns the container 3 to its initial position (upwards).

[0082] The container 3 preferably performs an axial movement or lifting movement during the addition of energy or during the clamping process or for fluid extraction and / or during the atomization or dispensing of the drug 2.

[0083] Preferably, a ventilation opening of the container 3 is opened during the initial loading or initial tensioning of the drive spring 7. This is preferably done by means of a device, which is preferably arranged in the housing part 18 and / or has a piercing element 22 for piercing the container 3 or a bottom seal of the container 3 during the initial venting. Preferably, the piercing element 22 is arranged on an axially acting spring 20, which comes into contact with the bottom 21 of the container during the initial loading.

[0084] In Fig. 3, the pressure generator 5 of the dispensing device 1 is shown in more detail, but schematically and not to scale.

[0085] The dispensing device 1 or the pressure generator 5 is preferably designed for dispensing, in particular for pumping or dosing, the medicinal product 2, preferably a liquid. The pressure generator 5 is particularly preferably designed as a piston pump. In particular, the dispensing device 1 or the pressure generator 5 is designed for very small pump volumes or doses. In the illustrated example, the pump volume is preferably more than 1 pl, in particular more than 5 pl, and / or less than 1 ml, in particular less than 500 mL, in particular less than 100 mL, most preferably less than 30 mL, and in particular substantially 10 to 20 mL, per piston stroke.

[0086] In order to ensure precise delivery and dosing of the desired volume, especially when the dispensing device 1 is first activated after a prolonged period of non-use, no air may enter the pressure generator 5, particularly during periods of non-use, as otherwise the dosing can no longer be carried out with the desired accuracy.

[0087] The dispensing device 1 or the pressure generator 5 preferably has an axis A. The axis A preferably corresponds to a main axis, longitudinal axis and / or axis of symmetry of the pressure generator 5 or conveying element 9 and / or the axis of movement of the conveying element 9. In particular, the pressure generator 5 extends substantially longitudinally along the axis A.

[0088] The terms "axial" and "radial" refer in particular to axis A. An "axial" direction, extension, movement, etc. is therefore preferably parallel to axis A, and a "radial" direction, extension, movement, etc. is preferably radial to axis A.

[0089] The dispensing device 1 or the pressure generator 5 preferably has a guide element 23 for guiding the conveying element 9, a sealing element 24, a receiving chamber 27 for receiving the sealing element 24 and in particular a fixing element 25 and / or contact element 26 for fixing or clamping and / or deforming the sealing element 24 in the receiving chamber 27.

[0090] In the (fully assembled) dispensing device 1, the sealing element 24 is arranged in the receiving chamber 27.

[0091] The fixing element 25 can preferably be fixed or attached to the guide element 23, or, in the case of the fully assembled dispensing device 1, is fixed or attached to the guide element 23.

[0092] Preferably, the fixing element 25 is designed to fix or secure the sealing element 24 in the receiving space 27.

[0093] The contact element 26 is preferably designed to contact or be positioned against 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.

[0094] Preferably, the position of the mounting element 26 can be fixed or defined by means of the fixing element 25. The fixing element 25 can preferably also be attached to the mounting element 26, for example by crimping, screwing, gluing, welding, or the like. This is illustrated by way of example in Fig. 3.

[0095] In the illustration example, the fixing element 25 and the attachment element 26 are formed by two separate components.

[0096] The two-part design of the fixing element 25 and the mounting element 26 has the advantage, for example, that the fixing element 25 and the mounting element 26 can be better optimized for their respective requirements. For instance, a particularly good fit with low tolerances in the receiving space 27 is important for the mounting element 26 to reliably ensure a good seal. Therefore, the mounting element 26 should have the lowest possible manufacturing tolerances, which are less critical for the fixing element 25. The fixing element 25, on the other hand, can be optimized, for example, for a material-locking, form-locking, or force-locking connection with the pressure generator 5 or guide element 23 or another component – ​​especially for defining the axial position. Furthermore, the mounting element 26 and the fixing element 25 can be manufactured as separate components from different materials.For example, the assembly element 26 can be made of a more dimensionally stable and / or stiffer or harder material, and / or the fixing element 25 can be made of a softer or more ductile material than the other component. A "more ductile material" is, in particular, a material with greater ductility, where "ductility" refers to a material's property of permanently deforming under shear stress before fracture, especially plastic deformation. Overall, this increases flexibility in assembly and / or the use of separate components, and allows for optimization of assembly processes.

[0097] A further advantage of designing the mounting element 26 and the fixing element 25 as separate components is that the requirements for these components can be better met by selecting different materials for them. A harder or more dimensionally stable material for the mounting element 26 is preferred because this allows for a permanent or consistent fixation of the sealing element 24 in the receiving space 27, thus ensuring a permanent or consistent seal by the sealing element 24. A softer or more ductile material for the fixing element 25 is preferred because this facilitates or enables a preferably forming attachment of the fixing element 25 to the guide element 23, in particular by pressing or crimping. Overall, therefore, selecting different materials for the mounting element 26 and the fixing element 25 is advantageous for meeting the requirements.

[0098] However, it is also possible that the mounting element 26 is formed integrally with the fixing element 25, or vice versa, and / or that the mounting element 26 represents or forms a section of the fixing element 25. The integral design results in fewer components, but is only optional.

[0099] The guide element 23 is preferably designed as a guide tube and / or preferably forms a channel 23b, which is particularly elongated and / or straight, for receiving or longitudinally displacing the conveying element 9. The conveying element 9 is preferably arranged in the guide element 23 or, in the fully assembled pressure generator 5 or dispensing device 1, is arranged or guided in the guide element 23. Preferably, the conveying element 9 is movable relative to the guide element 23, in particular longitudinally or axially displaceable within the guide element 23 or the channel 23b.

[0100] Preferably, the conveying element 9 forms a piston and / or the guide element 23 forms a cylinder or hollow cylinder. The guide element 23 and the conveying element 9 preferably together form a cylinder-piston arrangement, in particular a piston pump or part thereof.

[0101] The conveying element 9 preferably defines a pumping chamber or the pressure chamber 11 in the guide element 23, as indicated in Fig. 3. The conveying element 9 is preferably provided with the check valve 10, which is arranged, in particular, at the end of the conveying element 9 facing the pressure chamber 11.

[0102] In the illustrated example, the preferably hollow conveying element 9 forms or has a feed channel 28 for the drug 2. With appropriate axial movement, the drug 2 can be conveyed, in particular by suction, through the feed channel 28 and via the inlet or check valve 10 into the pressure chamber 11. On the pressure or output side, the pressure generator 5 optionally has an outlet valve (not shown) and, in particular, the discharge nozzle 12 for dispensing and, if necessary, atomizing the drug 2.

[0103] The proposed pressure generator 5 or the proposed dispensing device 1 is, in the illustrated example, designed in particular as an atomizer or inhaler. The drug 2 is alternately drawn through the feed channel 28 into the pressure chamber 11 by the conveying element 9 during a corresponding axial forward and backward movement, or pressurized there and dispensed via the discharge nozzle 12 and thereby applied, preferably atomized, i.e., a spray mist or aerosol 14 is formed from the drug 2, as indicated in Fig. 3.

[0104] In the non-triggered state shown in Fig. 1, the pressure chamber 11 is preferably smaller or minimized compared to the trigger-ready or loaded state shown in Fig. 2. In other words, in the non-triggered state, the conveying element 9 or the piston preferably immerses itself in the pressure chamber 11. In the trigger-ready or loaded state, the conveying element 9 or the piston is preferably further away from the discharge nozzle 12 and / or withdrawn from the pressure chamber 11 than in the non-triggered state shown in Fig. 1.

[0105] The dispensing device 1 or the pressure generator 5 or the guide element 23 preferably has the receiving space 27 for the sealing element 24 or forms or limits this space, in particular together with the attachment element 26.

[0106] It is preferred that the guide element 23 has or forms (at least partially) the receiving space 27 or at least partially limits it, in particular on the outside and / or on an axial or end face, preferably facing the discharge side or the pressure chamber 11 and / or discharge nozzle 12.

[0107] If necessary, the receiving space 27 can also be formed separately from the guide element 23, preferably wherein the receiving space 27 or the component having or forming the receiving space 27 in this case rests against or surrounds the guide element 23.

[0108] The receiving space 27 is designed in particular as a recess in the guide element 23, especially preferably as a groove or annular groove, annular shoulder or as a bushing.

[0109] Preferably, the volume of the receiving space 27 is determined primarily by the radial extent or width B of the receiving space 27 in the guide element 23 and the axial dimension Fl of the receiving space 27.

[0110] Preferably, the receiving space 27 is – at least partially – bounded by the guide element 23 and the mounting element 26 or fixing element 25. The guide element 23 can form a cylindrical or hollow cylindrical guide or receptacle for the mounting element 26 or fixing element 25.

[0111] Preferably, the receiving chamber 27 surrounds the conveying element 9 radially and / or annularly.

[0112] The conveying element 9 preferably forms an inner radial boundary of the receiving space 27. Preferably, the guide element 23 forms an axial and / or radial outer boundary for the receiving space 27.

[0113] In the illustrated example, the conveying element 9 has a circular cross-section with a diameter of more than 0.25 mm, preferably more than 0.5 mm, in particular more than 0.75 mm and / or less than 4 mm, preferably less than 3 mm, in particular less than 2.25 mm.

[0114] The conveying element 9 is preferably made of metal, in particular stainless steel. It is designed in particular as a foil element or capillary.

[0115] The conveying element 9 is preferably drawn and therefore has a relatively low tolerance with respect to its diameter. The sealing element 24 is preferably deformable, at least partially. The extent and / or type of deformation of the sealing element 24 is preferably specified by a deformation value.

[0116] The sealing element 24 is preferably designed as a continuous ring or as a molded seal or sealing ring, in particular adapted for receiving in the receiving space 27.

[0117] The sealing element 24 preferably has an opening 24a, in particular a central one.

[0118] In particular, the sealing element 24 is an O-ring with a cross-section that is at least substantially circular in its uninstalled or undeformed state, as shown in Fig. 5B. However, the sealing element 24 can also be designed as another type of molded seal, particularly with a non-circular cross-section in its undeformed state.

[0119] In its undeformed state, the sealing element 24 preferably has a different cross-section or volume than the receiving chamber 27 of the (fully assembled) dispensing device 1. Therefore, the sealing element 24 is preferably deformed during the assembly of the dispensing device 1, particularly during the attachment of the mounting element 26 or fixing element 25 to the guide element 23. This deformation of the sealing element 24 creates an elastic preload, which promotes optimal sealing performance and / or enables or results in a seal. The deformation or deformation value of the sealing element 24 is preferably not directly determinable or adjustable, but is instead determined by means of a corresponding characteristic value or derived from such a value.By using an assembly parameter M, it can be ensured in particular that the desired deformation of the sealing element 24 is achieved in the fully assembled dispensing device 1, or that the deformation value of the sealing element 24 assumes the desired value.

[0120] The sealing elements 24 are preferably manufactured in batches – i.e., in groups. In particular, a batch is produced from a specific quantity of as homogeneous a starting material as possible. Preferably, the sealing elements 24 of a batch exhibit only low variance or high reproducibility with regard to their significant dimensions, such as ring diameter or effective ring diameter, cross-section, volume, compressibility, or the like. Particularly preferably, the volumes of the sealing elements 24 of a batch deviate by less than 10%, particularly less than 5%, and most preferably less than 4% or 2% from the mean volume or target volume of the sealing elements 24 of the batch. In a specific example, the sealing elements 24 have a target volume or mean volume of more than 5 mm³. 3 and / or less than 10 mm 3 , particularly preferably about 7 mm 3 up to 8 mm 3, wherein all sealing elements 24 of the batch have a volume that is increased by a maximum of 0.3 mm 3 deviates from this target volume or average volume.

[0121] The sealing elements 24 are preferably manufactured by injection molding, in particular by means of an injection mold (not shown) with a plurality of cavities. Accordingly, a plurality of sealing elements 24 are produced in each injection molding operation.

[0122] Preferably, the sealing element 24 is a single component or separate part, particularly in the form of an O-ring or sealing ring. Alternatively, however, the sealing element 24 can also be directly molded onto the guide element 23 or contact element 26, particularly by means of two-component injection molding. In this case, the batches would then consist of guide elements 23 or contact elements 26 with sealing elements 24 molded into them or on them, instead of, as explained above, only of sealing elements 24.

[0123] The sealing elements 24 can vary from batch to batch, especially with regard to significant dimensions such as ring diameter or effective ring diameter, cross-section, volume, compressibility, etc. In addition to the tool-related dimensions (ring diameter, thickness, volume, surface finish), material-related or process-related dimensions such as compressibility can also vary.

[0124] The sealing elements of 24 different batches differ preferably only by manufacturing tolerances that arise from production in different batches.

[0125] However, it is also possible that the sealing elements from different batches differ significantly from one another, in particular having fundamentally different (target) dimensions, being made of different materials, exhibiting different deformation properties – for example, different compression moduli, elastic moduli, compression hardness, and / or indentation hardness – and / or different compression set. The sealing element 24 is preferably designed to seal the conveying element 9 against the guide element 23 – in particular, in a gas-tight or diffusion-tight manner. In particular, the sealing element 24 is designed or arranged such that no pharmaceutical substance 2 or fluid, in particular no gas and / or liquid, can escape from the pressure chamber 11 and / or between the guide element 23 and the conveying element 9.

[0126] In the illustrated example, the cross-section or (effective) cord thickness D of the uninstalled sealing element 24 is preferably more than 0.3 mm, particularly more than 0.5 mm, particularly preferably 1 mm or more, and / or less than 3 mm, particularly less than 2 mm, particularly preferably less than 1.5 mm. The inner diameter or the size of the central opening 24a of the sealing element 24 preferably corresponds approximately to the outer diameter of the conveying element 9.

[0127] Preferably, the sealing element 24 consists of an elastic material. An elastic material within the meaning of the invention is preferably a material with a modulus of elasticity of less than 100 MPa, preferably less than 50 MPa, and in particular less than 10 MPa.

[0128] The sealing element 24 preferably consists of a rubber-elastic material or rubber suitable for pharmaceuticals or food products. Preferably, the sealing element 24 consists of silicone, fluororubber (FKM), a thermoplastic elastomer (TPE), ethylene propylene diene monomer (EPDM), chloroisobutene isoprene rubber or chlorobutyl rubber (CIIR), bromobutyl rubber (BIIR), polyurethane (PUR) and / or nitrile rubber (NBR).

[0129] Different materials suitable for the sealing element 24 exhibit different properties. On the one hand, some materials, when in contact with a pharmaceutical, at elevated temperature, and / or at increased pressure, show an increased leakage rate and / or reduced diffusion tightness. In other words, it is possible that the sealing effect of the sealing element 24 is reduced upon contact with a pharmaceutical, at elevated temperature, or at increased pressure due to increased diffusion through the sealing element 24. With a sealing element 24 made of such a material, achieving a static seal or good bearing tightness is made more difficult because substances can diffuse through the sealing material or sealing element 24.The diffusion loss is preferably proportional to the size of the free surface and / or inversely proportional to the extent of the sealing element 24 in the direction of diffusion.

[0130] Furthermore, there are materials where, at elevated temperature and / or pressure, the contact stress on the sealing surfaces of the sealing element 24 decreases, particularly the surfaces in contact with the boundary of the receiving chamber 27. In other words, creep of the material or sealing element 24 is observed in these materials under elevated pressure and / or temperature. In this case, a bearing leak or poor static seal occurs, especially because insufficient compressive stress of the sealing material or sealing element 24 on the opposing surface, in this case, specifically the surface of the conveying element 9, leads to a leak due to the roughness or microporosity of the surface.

[0131] The problem with sealing the conveying element 9 by the sealing element 24 therefore lies particularly in fulfilling two somewhat conflicting requirements: On the one hand, a high preload pressure or significant deformation of the sealing element 24 in the receiving space 27 is desirable or advantageous in that it prevents bearing leakage or improves the static seal. On the other hand, however, a high preload pressure or significant deformation of the sealing element 24 leads to a deterioration of the dynamic seal, i.e., the seal of the conveying element 9 during movement of the conveying element 9 relative to the sealing element 24, since increased preload pressure intensifies the creep or flow of the material and also increases abrasion due to the relative movement between the conveying element 9 and the sealing element 24.Furthermore, excessive preload pressure not only leads to increased abrasion but also to more difficult operation or movement of the conveying element 9. This can result in the conveying element 9 not moving at all or not moving as intended, so that, for example, too low a dose of the drug 2 is dispensed per conveying stroke and / or insufficient atomization occurs.

[0132] In particular, the deformation value is a measure of the degree to which the sealing element 24 is deformed, or rather, the ratio between the cross-section or volume of the (deformed) sealing element 24 and the cross-section or volume of the receiving chamber 27 in the fully assembled dispensing device 1. The deformation value is therefore, in particular, a measure of the elastic preload of the sealing element 24 in the receiving chamber 27.

[0133] The sealing element 24 should be deformed, or its deformation value should be selected or set, in such a way as to optimally fulfill the aforementioned competing requirements. This means that, on the one hand, the deformation must be sufficiently large to create an elastic preload in the sealing element 24, thus preventing bearing leakage, and on the other hand, the deformation must be sufficiently small to ensure a good dynamic seal and prevent material flow and / or creep. The proposed method for mounting the sealing element 24 and the proposed dispensing device 1 are intended, in particular, to ensure that the sealing element 24 is positioned in the receiving space 27, or fixed in the receiving space 27 with a preload pressure, in such a way as to achieve both a good static and a dynamic seal.Furthermore, the proposed method is preferably suitable for a large number of materials or different materials.

[0134] In the installed state – i.e., with the pressure generator 5 mounted – the sealing element 24 is at least substantially contained within the receiving chamber 27, as shown in Fig. 3. The contact element 26 or fixing element 25 preferably rests axially against the sealing element 24 and fixes the sealing element 24 axially within the receiving chamber 27. Furthermore, the sealing element 24 preferably rests radially against the conveying element 9, which extends through the sealing element 24, forming a seal. The sealing element 24 is, in particular, clamped or compressed within the receiving chamber 27, i.e., deformed in the installed state. In the installed state, the sealing element 24 preferably has a substantially rectangular cross-section or at least a flat contact surface facing the conveying element 9.

[0135] To achieve a good seal and correspondingly accurate dosing, the desired fill level, i.e., the "target fill level," is preferably on average more than 90%, particularly more than 95%, and / or less than 110%, particularly less than 105%, and particularly preferably at least substantially 100%, particularly with a tolerance of 4%, 2%, or less. The "fill level" corresponds to the quotient of the volume of the undeformed sealing element 24 (as shown particularly in Fig. 5B) divided by the volume of the receiving chamber 27. The method according to the invention and the proposed dispensing device 1 are preferably designed to achieve or reproduce this or any other desired fill level.

[0136] The volume of the receiving space 27 is preferably variable and / or adjustable or definable during assembly. In the illustrated example, the support element 26, particularly in its axially clamped position against the sealing element 24, is preferably fixed or fastened to the guide element 23 by the fixing element 25. A defined position of the support element 26, and thus a defined axial length or area Fl of the receiving space 27 for the sealing element 24, can be achieved by means of corresponding axial or end-face contact surfaces.

[0137] The distance Fl of the receiving chamber 27 is in particular the (axial) distance between a base 27a or the annular surface or shoulder of the receiving chamber 27 formed by the guide element 23 and the end face of the contact element 26 facing the base 27a or sealing element 24, or the end face of a contact section 26a of the contact element 26, as indicated in Fig. 3. Preferably, the fixing element 25 is cap-shaped and / or overlaps the contact element 26 at an end face or at the free end.

[0138] The system element 26 is preferably designed at least substantially in an annular form. Preferably, the system 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.

[0139] The attachment element 26 preferably has a contact section 26a designed for direct contact with the sealing element 24. The contact section 26a is formed, in particular, by an axially end-facing section of the attachment element 26. In the fully assembled dispensing device 1, the contact section 26a preferably contacts the sealing element 24, or the contact section 26a fixes the sealing element 24 in the receiving chamber 27, or clamps the sealing element 24a in the receiving chamber 27.

[0140] The end face of the contact section 26a facing the sealing element 24 is preferably radially curved and / or adapted to the shape of the sealing ring or sealing element 24. This allows the dead space, in particular the area of ​​the receiving chamber 27 not filled by the sealing element 24, to be reduced or minimized. Preferably, the contact section 26a has a sealing lip facing the sealing element 24. The sealing lip preferably serves as an extrusion barrier and / or is designed to counteract creep of the sealing element 24 into the channel 23b.

[0141] The contact section 26a is preferably ring-shaped in cross-section (i.e., in section perpendicular to axis A), in particular circular-shaped.

[0142] The mounting element 26 preferably has a mounting surface or a stop 26b for the fixing element 25. In particular, the stop 26b is formed by an annular shoulder or a flange of the fixing element 25.

[0143] The fixing element 25 preferably has a counter surface 25a associated with the stop 26b in order to contact the stop 26b and / or to axially hold or fix the stop 26b and thus the support element 26. The support element 26 preferably has a particularly conical insertion section 26c, which facilitates the insertion of the conveying element 9 into the support element 26. Alternatively or additionally, the insertion section 26c also facilitates the insertion of a plunger 29 or a central element 30 during the determination of an assembly parameter M. The insertion section 26c preferably has a chamfer and / or rounding or is formed by such a chamfer and / or rounding. In particular, a central opening of the support element 26 is radially widened or enlarged towards the free end of the support element 26 by the insertion section 26c or the chamfer / rounding. Preferably, the position of the fixing element 25, in particular its axial position, is variable.The fixing element 25 can preferably be attached to the guide element 23 in various, in particular axial, positions relative to the guide element 23. The guide element 23 preferably has a fastening section 23a. The fastening section 23a is preferably arranged or formed on a circumferential side of the guide element 23.

[0144] In the illustration shown in Fig. 4, the fastening section 23a preferably has one or more engagement points, such as recesses 23c or a thread. However, the fastening section 23a can also be configured differently, for example, by having or being formed with an adhesive surface. Preferably, the fixing element 25 or contact element 26 can be attached to the guide element 23 in various discrete positions relative to the guide element 23. A "discrete position" within the meaning of the present invention is, in particular, a position that is defined or determined by the geometric shape of the fixing element 25, the contact element 26, and / or the guide element 23 or fastening section 23a.

[0145] The fixing element 25 can be attached to the guide element 23, for example, by screwing or gluing as indicated in Fig. 3, or, for example, by deformation, in particular by forming one or more beads, and / or, in particular, by radial engagement, preferably in one or more recesses 23c of the guide element 23, as indicated in Fig. 4E. In particular, the guide element 23 or the fastening section 23a can have several recesses 23c arranged at different axial positions.

[0146] In particular, the multiple recesses 23c define or realize several discrete positions of the fixing element 25 or the contact element 26 relative to the guide element 23. In other words, the fixing element 25 or the contact element 26 can preferably be attached to the guide element 23 in various discrete positions relative to the guide element 23 by means of the recesses 23c.

[0147] In particular, the axial position of the fixing element 25 or attachment element 26 and thus the fleas Fl and ultimately the volume of the receiving space 27 can be adjusted or varied.

[0148] In other words, it is preferred that in the fully assembled dispensing device 1, the fixing element 25 is attached to the guide element 23 or the mounting section 23a in a fixed or defined position, or that the fixing element 25 and / or the contact element 26 are fixed or secured in a fixed or unchangeable position relative to the guide element 23, whereby, however, various positions, in particular axial and / or discrete positions, relative to the guide element 23 can be selected or realized when fixing or securing the fixing element 25 and / or the contact element 26. In particular, this allows the volume of the receiving space 27 or the ratio between the volume of the receiving space 27 and the volume of the sealing element 24 to be selected or adapted to the sealing element 24. The variability of the position of the fixing element 25 or the contact element 26 is thus possible.The assembly of the plant element 26 constitutes in particular an independently realizable aspect of the present invention.

[0149] In particular, the position of the fixing element 25 and / or attachment element 26 defines a deformation of the sealing element 24 and / or a size or volume of the receiving space 27, so that the deformation of the sealing element 24 and / or the size or volume of the receiving space 27 can be varied by varying the position of the fixing element 25 and / or attachment element 26.

[0150] There are preferably several ways to attach the fixing element 25 to the guide element 23. The fixing element 25 can be attached to the guide element 23 by force-fit, form-fit and / or material-fit.

[0151] Preferred methods for fastening the fixing element 25 are screwing the fixing element 25, a (form-fit) fastening by means of pins, a forming fastening (for example casting or a material-fit fastening by curing material, in particular by UV-curable material, and / or an adhesive), a forming fastening (for example crimping or riveting), a machining fastening, welding, soldering or the like.

[0152] According to one example, the fixing element 25 can be designed as a nut or cap nut and can be fastened to the guide element 23 in the position specified by the assembly parameter M by tightening it, in particular with a defined torque. Preferably, the threads used here are designed as steep threads and / or are not self-locking. This is indicated by way of example in Fig. 3.

[0153] According to another example, the fixing element 25 can be designed as a crimp sleeve and crimped onto the guide element 23 or the fastening section 23a in the position specified by the assembly parameter M. Furthermore, the guide element 23 can have or be formed by one or more recesses 23c. The recesses 23c are preferably arranged on the outside of the guide element 23. In particular, the recesses 23c correspond to different (axial) and / or discrete positions of the fixing element 25 or define different axial and / or discrete positions of the fixing element 25 or the mounting element 26. This is indicated by way of example in Fig. 4A-E.

[0154] The recesses 23c are preferably designed as grooves or beads. The recesses 23c, in particular grooves or beads, can be continuous or form a complete circumferential pattern around the guide element 23, or they can be formed circumferentially by several separate recesses 23c.

[0155] In the embodiment shown in Fig. 4A-E with several recesses 23c, the fixing element 25 can preferably be attached or fixed to the guide element 23 in various discrete positions, which in particular correspond to individual recesses 23c.

[0156] Alternatively or additionally, only one or exactly one such recess 23c or groove or bead can be provided, wherein several crimp sleeves with different axial lengths are provided, so that different assembly parameters M correspond to different fixing elements 25 or crimp sleeves with different axial lengths or are realized by different fixing elements 25.

[0157] The fixing element 25 can be pre-formed to engage in a recess 23c, for example, by having a circumferential or otherwise correspondingly shaped edge for engaging the recess 23c. However, this is not strictly necessary. Even such pre-formation of the fixing element 25 in combination with the recesses 23c defines a discrete position of the fixing element 25 or the contact element 26. It is also possible that the fixing element 25 does not have such a preform, but that only the guide element 23 or the fastening section 23a has one or more recesses 23c, wherein the fixing element 25 is continuously displaceable relative to the guide element 23 or fastening section 23a and a deformation tool deforms the fixing element 25 into the recess 23c to fasten or fix the fixing element 25.According to another example, the fixing element 25 can be glued or welded to the guide element 23 in the position specified by the assembly parameter M, in particular by laser welding, ultrasonic welding and / or friction welding.

[0158] Optionally, the fixing element 25 can be attached to the support element 26, whereby the fixing element 25 can be attached to the support element 26 in the same way as the fixing element 25 is attached to the guide element 23. The preceding descriptions for attaching the fixing element 25 to the guide element 23 therefore apply analogously to attaching the fixing element 25 to the support element 26. Preferably, a fixed connection between the support element 26 and the fixing element 25 is established only after the support element 26 has been positioned. In the embodiment shown in Fig. 4E, the support element 26 or its stop 26b has a groove or bead radially on its outer surface, wherein the fixing element 25 is formed into this groove or bead by crimping and thus attached to the support element 26. In Fig. 6, a part of the dispensing device 1 or the pressure generator 5 according to a further preferred embodiment is shown schematically.Fig. 6 shows a side view of the printing unit 5 shown in a sectional view in Fig. 4E, with the fixing element 25 omitted and only the contact element 26 and the guide element 23 shown.

[0159] According to the embodiment shown in Fig. 6, the fixing or positioning element 25, 26 can preferably be engaged in various axial and / or discrete positions relative to the guide element 23. In particular, this allows various discrete positions of the fixing or positioning element 25, 26 relative to the guide element 23 to be fixed or fixed.

[0160] Preferably, the fixing or positioning element 25, 26 and / or the guide element 23 has a positioning device 31 for positioning the fixing or positioning element 25, 26 relative to the guide element 23. The positioning device 31 is preferably formed by or has corresponding surfaces or sections of the positioning element 26 and the guide element 23. The positioning device 31 is preferably arranged on an end face of the fixing element 26 that is associated with or facing the guide element 23 and / or on an end face of the guide element 23 that is associated with or facing the fixing element 26.

[0161] In the illustrated example, the positioning device 31 is formed by or has one or more helical structures 31a. Preferably, both the mounting element 26 and the guide element 23 have a helical structure 31a.

[0162] The helical structure 31a allows the (especially axial) position of the support element 26 relative to the guide element 23 to be preferably adjustable or variable. In particular, the position of the support element 26 relative to the guide element 23 can be changed by rotating the support element 26 about the axis A or by rotating the support element 26 relative to the guide element 23. During such rotation, the helical structures 31a of the support element 26 and the guide element 23 preferably slide along one another, thus changing the relative axial position of the guide element 23 and the support element 26 to each other.

[0163] Instead of the helical structure 31a, however, only an inclined plane or sloping surface or the like may be provided. Preferably, the axial position of the fixing element 25 or contact element 26, in particular relative to the guide element 23, is determined or definable by the rotational position of the fixing element 25 or contact element 26. This is preferably enabled or realized by the positioning device 31, in particular by the inclined plane or sloping surface or helical structure 31a.

[0164] The positioning device 31 preferably has or is formed by one or more detent elements 31b. In particular, the detent elements 31b allow the contact element 26 to be engaged in a (defined) axial position relative to the guide element 23 on the guide element 23.

[0165] Preferably, the mounting element 26 and the guide element 23 have corresponding locking elements 31b. In particular, the locking elements 31b of the mounting element 26 and the guide element 23 are designed to engage with each other or to interact. Particularly preferably, the locking elements 31b are designed such that rotation of the mounting element 26 relative to the guide element 23 is only permitted in one direction of rotation about the axis A, and rotation in a direction opposite to this direction of rotation is prevented. This can be achieved, as shown in Fig. 6, by a corresponding design of the locking elements 31b with inclined and vertical surfaces.

[0166] When the attachment element 26 is engaged with the guide element 23, or after the dispensing device 1 has been assembled, the positioning devices 31, flexible structures 31a, and / or locking elements 31b of the attachment element 26 and guide element 23 are preferably in contact or abutting each other. For illustrative purposes only, a gap between the attachment element 26 and the guide element 23 is shown in Fig. 6.

[0167] The positioning device 31, in particular the inclined planes or flexible structures 31a and / or locking elements 31b, preferably defines various discrete positions of the fixing or contact element 25, 26 relative to the guide element 23. In other words, the fixing element 25 or contact element 26 can preferably be attached to the guide element 23 in various discrete positions relative to the guide element 23 by means of the positioning device 31, in particular the inclined planes or flexible structures 31a and / or locking elements 31b, and in particular can be locked into place.

[0168] The following section focuses in particular on proposed methods for assembling the dispensing device 1 or for assembling (a plurality of) dispensing devices 1.

[0169] In particular, an assembly method is described below in which sealing elements 24 are available in batches. Within a batch, the variance with respect to the significant dimensions of the sealing elements 24 is preferably low. In this method, an assembly parameter M is preferably first determined using a sample of a small quantity of sealing elements 24 from the batch, and this assembly parameter M is then subsequently used for each sealing element 24 during the assembly of the sealing elements 24 in the batch. In particular, the assembly parameter M is determined (batch by batch) before or independently of the actual assembly of the sealing elements 24. This method is specifically referred to as a batch method.

[0170] In a further assembly method described following the batch method, an assembly parameter M is preferably determined individually or separately for each sealing element 24 to be assembled, and the sealing element 24 is assembled using this assembly parameter M. In particular, the assembly or fixing of the sealing element 24 takes place during or immediately after the determination of the assembly parameter M. In this method, the sealing elements 24 can differ more significantly from one another with regard to their significant dimensions and / or originate from different batches. Nevertheless, this method can also be applied to sealing elements 24 that are available in batches and exhibit low variance with regard to their significant dimensions. This method is specifically referred to as the individual method.

[0171] First, however, the batch process will be discussed in more detail. Preferably, an assembly parameter M is determined separately for each batch of sealing elements 24. The procedure for determining the assembly parameter M is described in more detail below, after an overview of the entire batch process has been given. A batch preferably comprises a plurality of sealing elements 24, preferably more than 10,000, preferably more than 100,000, in particular more than 200,000, and / or fewer than 1,000,000, in particular fewer than 800,000, sealing elements 24. The assembly parameter M is preferably determined using a sample or subset of sealing elements 24 from the batch.

[0172] The sample comprises, in particular, a small number, 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, of sealing elements 24 from the batch. Preferably, the size of the sample depends on the size of the batch, in particular, larger samples being used for larger batches.

[0173] Preferably the sample has less than 50%, preferably less than 20%, in particular less than 10%, especially preferably less than 5%, most preferably less than 2%, of the sealing elements 24 of the batch.

[0174] Preferably, the determination of the assembly parameter M or its value is carried out separately from the actual assembly of the sealing elements 24 or the dispensing device(s) 1, in particular in a test facility not shown.

[0175] The receiving chamber 27 of the test system preferably has the same dimensions as the receiving chamber 27 of the dispensing device 1. However, for the sake of simplicity, the method is described below using a receiving chamber 27 of the dispensing device 1.

[0176] Likewise, the system element need not be system element 26 of the dispensing device 1, but can also be formed by a test element of the test system. In this case, the test element is preferably similar to or identical in design to system element 26.

[0177] The test system preferably does not include a complete dispensing device 1 or a complete pressure generator 5, but only a receiving chamber 27 with the same dimensions as the receiving chamber 27 of the dispensing device 1 or the pressure generator 5. Preferably, the receiving chamber of the test system is also made of the same material as the receiving chamber 27 of the dispensing device 1.

[0178] It is not essential that the test system has a guide element 23 of the dispensing device 1 that is structurally identical to the guide element 23 of the dispensing device 1 (which has or forms the receiving space 27), or that the receiving space of the test system is formed by a guide element that is structurally identical to a guide element 23 used in the dispensing device 1. Rather, what is decisive for a simulation of the dispensing device 1 or the deformation of the sealing element 24 in the dispensing device 1 or of the receiving space 27 is merely that the receiving space simulated in the test system corresponds as closely as possible to the receiving space 27 of the dispensing device 1 in terms of dimensions and / or material. Therefore, preferably, as mentioned, the test element of the test system is designed similarly to or identically to the system element 26. Preferably, the test element consists of the same material as the system element 26 and / or has the same diameter.Cross-section perpendicular to axis A as shown by the installation element 26.

[0179] Furthermore, it is preferred that the test setup includes a plunger 29 or a central element 30. The plunger 29 or the central element 30 preferably simulates the conveying element 9. It is preferred that the plunger 29 or the central element 30 is made of the same material as the conveying element 9 and / or has the same diameter or cross-section perpendicular to axis A as the conveying element 9. The plunger 29 and the central element 30 will be described in more detail later.

[0180] Preferably, the test system does not include components of the dispensing device 1 or the pressure generator 5 that are not relevant for sealing the receiving chamber 27, for example the discharge nozzle 12 or all parts that are not part of the pressure generator 5, or the test system does not have such components.

[0181] In this sense, the recording chamber 27 or the printing generator 5 or the dispensing device 1 is preferably only simulated in the test facility.

[0182] In the batch method, or batch-wise determination of the assembly parameter M, an assembly parameter M is preferably first determined for all sealing elements 24 of the sample in the manner described below. Preferably, the mean value is then calculated from the assembly parameters M determined separately for the sealing elements 24 of the sample. This mean value then preferably represents the assembly parameter M of the batch and is used, in particular, for each assembly of a sealing element 24 of the batch. The assembly parameter M is preferably selected or set such that for different batches of sealing elements 24, the 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 results – at least substantially.In other words, the assembly parameter M is preferably selected such that the same deformation value or fill level of the sealing element 24 in the receiving chamber 27 results with each assembly of a dispensing device 1. The sealing effect is largely determined by the deformation value or fill level, thus ensuring a reliable seal even with differences between the sealing elements 24 from different batches. A "same" or "at least substantially the same" deformation value or fill level is preferably understood to mean fill levels or deformation values ​​that differ only slightly from one another and / or are identical within a tolerance. Therefore, it is possible that identical deformation values ​​or fill levels do not correspond exactly or differ slightly from one another. Two deformation values ​​or...Fill levels are considered to be the same, in particular, if they differ from each other by less than 10%, preferably less than 5%, particularly less than 2%, and most preferably less than 1%.

[0183] The assembly parameter M is preferably an adjustable, in particular geometric, value that must be adhered to during the assembly of the dispensing device 1 and / or is realized in the fully assembled dispensing device 1. Preferably, the assembly parameter M can be variably specified in the settings of an assembly sequence. The assembly parameter M preferably represents or corresponds to a relative position of the fixing element 25 and / or contact element 26 with respect to the guide element 23. Preferably, the assembly parameter M is a geometric parameter. In particular, the assembly parameter M or its value is an axial position of the fixing element 25 and / or contact element 26. In other words, this position is preferably defined by the assembly parameter M or its value.Since the position of the fixing element 25 and / or the mounting element 26, as explained above, preferably correlates with the volume of the receiving space 27 and thus preferably also with a deformation of the sealing element 24, the (batch-wise) use or specification of the assembly parameter M can easily ensure that a reliable seal of the conveying element 9 is achieved by the sealing element 24 with different batches of sealing elements 24.

[0184] It is also possible that the assembly parameter M corresponds only indirectly to a position of the fixing element 25 or the mounting element 26, for example, by defining or forming the assembly parameter M through a feed path traversed by a part of a device for mounting the dispensing device 1 or for attaching the fixing element 25 to the guide element 23, or the like. According to another example, in which the assembly parameter M corresponds particularly only indirectly to a position of the fixing element 25 or the mounting element 26, the assembly parameter M can be defined or formed by a rotation angle, a screw drive, or the like of a component to be fastened, in particular to be screwed. In particular, the assembly parameter M can be formed by a rotation angle, a screw drive, or the like if the fixing element 25 is designed as a nut or cap nut, as explained above by way of example.By specifying a rotation angle or screw drive, the end position of the component or nut, and thus indirectly its axial position or the dimensions of the receiving space 27, can be determined.

[0185] Preferably, different assembly parameters M or different values ​​of the assembly parameter M correspond to different volumes of the receiving space 27 and / or to different fleas Fl of the receiving space 27. In other words, preferably each assembly parameter M or each value of the assembly parameter M corresponds to a specific volume of the receiving space 27 or a specific fleas Fl of the receiving space 27.

[0186] Alternatively or additionally, the assembly parameter M can also correspond to a specific force by which the sealing element 24, fixed in the receiving space 27, is deformed or fixed. Preferably, the volume of the receiving space 27 or the area Fl of the receiving space 27 are each directly correlated with a specific force or pressure with which the sealing element 24 is deformed in the receiving space 27. Therefore, instead of a geometric parameter such as a position of the mounting element 26 or an area Fl of the receiving space 27, a specific force can also be used to define the assembly parameter M or as the assembly parameter M. In particular, this force then corresponds to a specific volume or area Fl of the receiving space 27.

[0187] The volume or size Fl of the receiving chamber 27 can preferably be adjusted or determined by means of the assembly parameter M. In particular, 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 sealing elements 24, so that the volume of the receiving chamber 27 can be adapted to the respective sealing element 24 or the respective batch of sealing elements 24 and the same degree of filling or the same sealing effect or sealing is achieved for different sealing elements 24 or batches of sealing elements 24.

[0188] Preferably, the assembly parameter M for a batch is first determined using a subset or sample of sealing elements 24 from the batch. Subsequently, the determined or selected assembly parameter M is preferably used for each assembly of a dispensing device 1 or fixing of a sealing element 24 of the respective batch in a receiving chamber 27. In particular, the assembly parameter M is a value that can be (easily) set during the assembly of the dispensing device 1 and / or does not need to be measured or determined, thus enabling fast and efficient, and in particular automated, assembly of a large number of dispensing devices 1.

[0189] The assembly of the sealing elements 24 or dispensing devices 1 preferably takes place in a process separate from the determination of the assembly parameter M and / or in a different system than the determination of the assembly parameter M. Preferably, the assembly of the sealing elements 24 or dispensing devices 1 takes place in a fully automated process. In particular, a large number of dispensing devices 1 are assembled at a high rate. Specifically, several hundred or several thousand dispensing devices 1 are assembled per hour.

[0190] For assembly, a sealing element 24 is first inserted into a receiving chamber 27 of a dispensing device 1. Subsequently, a fixing element 25 and / or a positioning element 26 is inserted into the receiving chamber 27. As described above, the fixing element 25 and the positioning element 26 can either be formed by different, separate components or represent different sections of a single component. In a preferred embodiment, which is also shown in the figures, the fixing element 25 and the positioning element 26 are formed by two separate components. In this case, the positioning element 26 is inserted into the receiving chamber 27.

[0191] The fixing element 25 or mounting element 26 is preferably moved into the receiving space 27 to such an extent that the sealing element 24 is deformed and, in particular, the deformation value of the sealing element 24 reaches or exceeds the threshold value. For this purpose, the predefined assembly parameter M is used, which preferably determines how far the fixing element

[0192] 25 or attachment element 26 is moved into the receiving element 27 or in which position the fixing element 25 and / or attachment element 26, in particular the attachment element 26, is to be fixed by means of the fixing element 25.

[0193] Preferably, the mounting element 26 is moved into the desired position by means of a punch or plunger. The punch or plunger can, for example, be designed in a fundamentally similar way to the plunger 29 described in more detail later, which is used in determining the assembly parameter M and is shown in Figures 4A-D. Preferably, however, the punch or plunger used in the assembly does not have a central element 30 and / or the punch or plunger does not penetrate the mounting element 26 and / or the sealing element 24 during assembly.

[0194] The fixing element 25 is preferably pushed over the mounting element 26 and / or the guide element 23 after the mounting element 26 has been positioned in the position corresponding to or defined by the mounting parameter M.

[0195] However, it is also possible that the fixing element 25 is already pushed over the attachment element 26 and / or in contact with the attachment element 26 when the attachment element 26 is positioned, so that the fixing element 25 and the attachment element

[0196] The positioning element 26 is moved simultaneously in the direction of the sealing element 24. The positioning element 26 is moved indirectly via the fixing element 25 in the direction of the sealing element 24. In this case, the plunger or ram for moving the fixing element 25 and positioning element 26 preferably contacts the fixing element 25 and acts only indirectly on the positioning element 26 via the fixing element 25. When the fixing element 25 and / or positioning element 26 have reached the desired position, or the position defined by or corresponding to the assembly parameter M, the fixing element 25 is preferably attached to the guide element 23. It is preferred that the fixing element 25 is also attached to the positioning element 26.The term "fixing" a sealing element 24 refers in particular to securing or clamping the sealing element 24 in the receiving space 27 such that the sealing element 24 cannot move and / or be demolded in the receiving space 27, and in particular cannot return to its undeformed original shape. This is preferably achieved by securing or clamping the sealing element 24 in the receiving space 27 by means of the fixing element 25 and optionally by means of the contact element 26, wherein the fixing element 25 or contact element 26 presses on the sealing element 24 and thus deforms it, so that the sealing element 24 bears against the boundaries of the receiving space 27 over a large area or as completely as possible, in particular against the guide element 23 and / or the fixing element 25 or contact element 26.In the fully assembled dispensing device 1, the sealing element 24 preferably rests against the conveying element 9 guided by the sealing element 24. Further deformation of the sealing element 24 after assembly is preferably limited or prevented by the receiving chamber 27 or the guide element 23, the fixing element 25 or contact element 26, and preferably the conveying element 9.

[0197] The sealing element 24 is preferably fixed by fixing the support element 26 and / or by attaching the fixing element 25 to the guide element 23 and / or support element 26. Preferably, the attachment of the fixing element 25 to the guide element 23 defines, determines, or fixes the size Fl and / or the volume of the receiving space 27. After fixing the fixing element 25 and / or support element 26, the conveying element 9 is preferably mounted. The conveying element 9 is then inserted into the channel 23b by the fixing element 25, the support element 26, and / or sealing element 24. However, the mounting or insertion of the conveying element 9 can also take place before fixing the fixing element 25 and / or support element 26.

[0198] Preferably, during the assembly of the dispensing device, the relative position of the fixing element 25 and / or the contact element 26 with respect to the guide element 23 can be predetermined or adjusted by means of the assembly parameter M. Preferably, a displacement measurement or displacement measurement takes place during assembly, by means of which the displacement Fl of the receiving chamber 27 and / or the relative position of the fixing element 25 or contact element 26, in particular relative to the receiving chamber 27 or its base 27a and / or the guide part 23, can be directly or indirectly checked and / or controlled. All common displacement measurement methods are preferably applicable here, for example, tactile, optical, inductive methods, or the like. In particular, by determining the assembly parameter M or its value batchwise, it is not necessary to redetermine or adjust the assembly parameter M or its value for each assembly of a dispensing device 1, but rather the assembly parameter M or its value can be used continuously.Its value is preferably first determined for a batch (using a subset or sample of sealing elements 24 from the batch) and then used for each sealing element 24 of that batch. This simplifies and speeds up the assembly process for dispensing devices 1.

[0199] The determination of the assembly parameter M will now be explained in more detail, in particular with reference to Figures 4A to 4D and 5.

[0200] To determine the assembly parameter M, the respective sealing element 24 is first arranged in the receiving space 27 or inserted into the receiving space 27. Subsequently, the fixing element 25 or the contact element 26 is preferably placed onto the sealing element 24 or brought into contact with the sealing element 24.

[0201] This is illustrated in Figures 4A-D. Figure 4A shows that the attachment element 26 has already been inserted into the receiving chamber 27, but is not yet in contact with the sealing element 24. In Figure 4B, the attachment element 26 has been moved into the receiving chamber 27 far enough that it is in contact with the sealing element 24.

[0202] Figure 4C shows the same situation as Figure 4A. Figure 4D shows the same situation as Figure 4B. Figures 4C and 4D differ from Figures 4A and 4B only in that the sealing element 24 in Figures 4C and 4D has a smaller volume, a smaller diameter, or a smaller cord thickness D than the sealing element 24 in Figures 4A and 4B. The sealing element 24 is then preferably deformed or pressed into the receiving space 27, particularly by means of the fixing element 25 and / or contact element 26. This is achieved, in particular, by applying a force or pressure to the sealing element 24, particularly by means of the fixing element 25 and / or contact element 26. Deformation of the sealing element

[0203] 24 by the system element 26 for determining the assembly parameter M at or during the determination of the assembly parameter M is shown in particular in Figure 4D.

[0204] Preferably, the sealing element 24 is deformed by an axial force or pressure acting on it. However, it is also possible to deform the sealing element 24 alternatively or additionally by a radial force. Preferably, after the receiving space 27 has been defined in the axial direction (i.e., in particular after the fixing element 25 or the contact element 26 has been placed on it), a radially inward force is used. Preferably, the force or pressure is applied to the sealing element 24, or the sealing element 24 is deformed, by means of a plunger 29. In particular, the fixing element 25 or the contact element 26 is moved by means of the plunger 29 toward the sealing element 24 or into the receiving space 27, so that the fixing element 25 or the contact element 26 is deformed.

[0205] The sealing element 24 is contacted by the component 25 or the component 26, and the sealing element 24 is deformed by exerting a force or pressure on it. The plunger 29 is shown by way of example in Fig. 4A-D.

[0206] Preferably, the plunger 29 acts only indirectly on the sealing element 24. It is preferably provided that the plunger 29 acts, particularly axially, on or presses against the fixing element 25 and / or the contact element 26. In particular, the plunger 29 is moved axially towards the fixing element 25 or contact element 26, so that the fixing element 25 or contact element 26 is moved axially in the direction of the sealing element 24, thereby deforming the sealing element 24. The plunger 29 is preferably not part of the dispensing device 1, but rather part of a test system in which the assembly parameter M is determined.

[0207] To determine the assembly parameter M, a central element 30 is preferably guided into the channel 23b or through the (central) opening 24a of the sealing element 24. The volume of the receiving space 27 is preferably reduced or limited by the central element 30. The central element 30 is shown by way of example in Fig. 4A-D.

[0208] In particular, the central element 30 represents an inner radial boundary of the recording space 27 during the correlation measurement or determination of the assembly parameter M.

[0209] The central element 30 preferably has the same diameter or, in the radial direction, the same outer dimensions as the conveying element 9.

[0210] Preferably, the central element 30 is a section of the plunger 29 or formed integrally with the plunger 29. However, the central element 30 can also be formed separately from the plunger 29 or constitute a separate component. The central element 30 can be tapered, conical, and / or rounded in at least one section, so that when the central element 30 is axially advanced, the radial extent or width B of the receiving space 27, defined by the central element 30, is reduced. This can facilitate the insertion of the central element 30 into the channel 23b or through the opening 24a of the sealing element 24 and / or prevent damage to the sealing element 24.

[0211] In principle, the central element 30 can also be formed by the conveying element 9. Preferably, during the correlation measurement or determination of the assembly parameter M, the sealing element 24 is pressed against the central element 30 and, in particular, deformed in the process.

[0212] After determining the assembly parameter M, the central element 30 is preferably removed again from the channel 23b or the opening 24a of the sealing element 24.

[0213] The assembly parameter M is preferably selected such that, when the sealing element 24 is fixed, a deformation value corresponding to the deformation of the sealing element 24 reaches or exceeds a threshold value. A "threshold" value is defined as both when the deformation value is initially smaller than the threshold value and subsequently reaches a value greater than the threshold value, and vice versa, i.e., when the deformation value is initially larger than the threshold value and subsequently reaches a value less than the threshold value.

[0214] Multiple threshold values ​​can also be specified, with the assembly parameter M preferably being chosen such that the deformation value lies between the threshold values. In particular, the threshold values ​​can therefore represent a maximum and a minimum value for the deformation value.

[0215] The deformation value preferably corresponds to the deformation and / or compression of the sealing element 24. In other words, the deformation value is preferably a value or numerical measure that indicates the extent and / or manner in which the sealing element 24 is deformed and / or compressed. The deformation value is preferably determined indirectly using a characteristic value, as will be explained in more detail below.

[0216] Figures 5B and 5C show a schematic representation of the deformation of the sealing element 24.

[0217] Fig. 5B shows the undeformed sealing element 24, in particular before it is inserted into the receiving chamber 27. In the illustration shown in Fig. 5B, the sealing element 24 has a circular cross-section with a diameter or cord thickness D. However, the sealing element 24 and its cross-section can, in principle, be of any shape.

[0218] Figure 5C shows a deformed sealing element 24. In particular, the representation in Figure 5C corresponds to a sealing element 24 inserted and fixed in a fully assembled dispensing device 1 or its receiving chamber 27. As can be seen from Figure 5C, the sealing element 24 has been deformed compared to the initial situation in Figure 5B and, in particular, its outer shape has been adapted to the shape of the receiving chamber 27. During the deformation of the sealing element 24, a deformation preferably occurs first, preferably elastic, 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 chamber 27. Typically, with a further increase in the pressure or force applied or deformation of the sealing element 24, a volume compression occurs following the pure change in shape, i.e., a change in volume.Reduction of the volume of the sealing element 24, in particular in addition to the primarily pure change in shape.

[0219] Preferably, the threshold value corresponds to a deformation value that corresponds to the onset of volume compression of the sealing element 24, or at which the volume compression begins. However, depending on the material of the sealing element 24, it may also be desirable or advantageous to select a threshold value that is specifically above or below the value at which volume compression begins. For example, for a material with high creep behavior, such as a thermoplastic elastomer (TPE), it may be advantageous to set the threshold value so that no volume compression has yet begun.

[0220] The assembly parameter M is preferably determined based on the deformation behavior and / or friction behavior of the sealing element 24 during a deformation of the sealing element 24 in the receiving space 27.

[0221] The investigation or determination of the deformation behavior and / or friction behavior is explained in more detail below with reference to Figures 4A-D and 5.

[0222] To investigate or determine the deformation behavior, a (gradually increasing) force is preferably applied to the sealing element 24 by means of the plunger 29, fixing element 25 and / or contact element 26, thereby deforming the sealing element 24. In particular, for several different deformations or deformation values ​​of the sealing element 24, the force required to achieve each of these deformations or deformation values ​​is determined. Preferably, a displacement corresponding to the force is also determined.

[0223] To investigate or determine the friction behavior, preferably a boundary of the receiving space 27, in particular the central element 30, and the sealing element 24 are moved relative to each other, and the frictional force between the sealing element 24 and the boundary is determined at several points in time during the deformation. The deformation value is preferably determined at least indirectly through or during the investigation or determination of the deformation and / or friction behavior of the sealing element 24. However, the deformation value itself does not necessarily have to be directly determined or known. For example, it is possible that previous tests have revealed which forces or frictional forces required for deformation between the sealing element 24 and the boundary correspond to a specific deformation value.

[0224] To investigate the deformation and / or friction behavior, a characteristic value is preferably measured. This characteristic value allows conclusions to be drawn about the deformation value, or the deformation value can be determined directly. In other words, the characteristic value is preferably a quantity or value that is determined or measured in order to determine, calculate, and / or derive the deformation value from the characteristic value. The characteristic value is preferably correlated with the deformation value. Preferably, each value of the characteristic value corresponds to a specific deformation value.

[0225] The characteristic value is preferably a force and / or pressure exerted on the sealing element 24 to deform it, and / or a position, particularly axial, of the plunger 29 with which the sealing element 24 is deformed. In other words, preferably the force and / or pressure with which the sealing element 24 is deformed is measured, and / or the position of the plunger 29 with which the sealing element 24 is deformed is measured. In particular, the force can be known indirectly through the position of the plunger 29. This allows the desired deformation value, and thus a reliable seal or sealing effect, to be achieved for different sealing elements 24.

[0226] The force is preferably related to a specific area, in particular the area of ​​the receiving chamber 27 or the floor 27a. In this respect, the force corresponds directly to a pressure, or is a force normalized or related to an area. The term "force" is preferably also interchangeable with the term "pressure".

[0227] The deformation behavior is preferably determined by the force or pressure exerted on the sealing element 24 to deform it. Alternatively or additionally, the deformation behavior is (indirectly) determined by the position, particularly axial, of the plunger 29 and / or the fixing or contact element 25, 26. The position of the plunger 29 and / or the fixing or contact element 25, 26, in particular, defines a height H of the receiving space 27.

[0228] In particular, the height H of the receiving chamber 27 or a correlated quantity, such as the feed or axial position of the plunger 29 and / or fixing or mounting element 25, 26, can be specified or set, and the corresponding force can be determined or measured. Conversely, it is also possible to specify or set the force and determine or measure the height H of the receiving chamber 27 or the correlated quantity corresponding to the specified or set force.

[0229] The force or pressure and / or position of the plunger 29 are preferably measured. However, it is also possible that the force, pressure, and / or position are known, predetermined, or calculable / determinable without explicit measurement, for example, from the magnitude of a control parameter used to move the plunger 29, such as an (electrical) voltage or the like, by which the force exerted by the plunger 29 is controlled or regulated. Alternatively or additionally, to determine the deformation behavior of the sealing element 24 during deformation, the friction behavior can also be determined, as already mentioned, while the sealing element 24 is being deformed. The deformation of the sealing element 24 in the receiving space 27 can also be determined (indirectly) by measuring an auxiliary variable such as, for example,a frictional force that occurs between the sealing element 24 and a boundary of the receiving space 27 that is in contact with the sealing element 24 and moving relative to it. The frictional force increases with increasing contact pressure of the sealing element 24 against the boundary, the increase of which depends on the deformation of the sealing element 24 and / or the size of the contact area between the sealing element 24 and the boundary of the receiving space 27. In particular, the contact pressure increases with increasing deformation of the sealing element 24, resulting in a changed, especially increased, frictional force between the sealing element 24 and the boundary of the receiving space 27. Initially, this involves a (at least predominantly elastic) deformation of the sealing element 24, which gradually transitions into a compression of the sealing element 24 with increasing deformation. In particular, the increase orThe gradient of the frictional force during compression of the sealing element 24 is greater than during elastic deformation of the sealing element. Therefore, it is possible to draw conclusions about the deformation or deformation behavior of the sealing element 24 based on its frictional behavior, and in particular to determine the deformation or deformation behavior of the sealing element 24 (indirectly or indirectly).

[0230] To determine the friction behavior, the sealing element 24 is preferably moved relative to a boundary of the receiving space 27. This can be done, for example, by moving the plunger 29 or the central element 30 relative to the sealing element 24, particularly axially or along axis A. In this case, the central element 30 forms the boundary of the receiving space 27, which is moved relative to the sealing element 24. Preferably, the plunger 29 or the central element 30 is oscillated or moved back and forth. In particular, the force required to move the plunger 29 or the central element 30 is measured. This measured force 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 measured force orFrictional force, as a (particularly indirect) measuring aid, preferably represents the characteristic value from which the deformation value and thus, in particular, the threshold value is determined, calculated, or derived.

[0231] In this method, it is preferably provided that the fixing element 25 or the mounting element 26 is fixed or moved or pressed into the receiving space 27 by means of a further plunger not shown in Figures 4A-D.

[0232] In principle, the frictional force can also be measured in other ways, 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 torsional friction or torsional friction force that occurs.

[0233] One advantage of determining the friction 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 the measurement of the friction force.

[0234] A further advantage of determining the frictional behavior during the deformation of the sealing element 24 is that the threshold value or assembly parameter M can be determined directly based on a parameter or characteristic value, namely the frictional force, which affects the properties of the aerosol 14 generated by the dispensing device 1. The greater the frictional force between the sealing element 24 and the conveying element 9, which occurs when the conveying element 9 moves to generate the aerosol 14, the less energy is available for generating the aerosol 14 from the fluid, because some of the total available energy is lost through friction. Excessive frictional force therefore leads to the droplets of the generated aerosol 14 being less uniform and / or smaller in size and / or impairing, in particular shortening, the duration of a spray.This has a detrimental effect on the effectiveness and exact dosage of the drug sprayed as an aerosol 14 by the delivery device 1.

[0235] In particular, a [method / method] is used to investigate or determine the deformation behavior or friction behavior and / or to determine the assembly parameter M.

[0236] Force-displacement curve recorded. The assembly parameter M is particularly preferably determined based on the shape of the force-displacement curve.

[0237] Figure 5A shows an example of a force-displacement curve. Displacement is plotted on the x-axis and force F on the y-axis.

[0238] Figure 5A represents the path through the fleas Fl of the receiving chamber 27. However, the path can also correspond to the distance traveled or the position of the plunger 29 and / or fixing or contact element 25, 26 with which the sealing element 24 is deformed. The path can be measured or otherwise known, for example from a control parameter such as an electrical voltage or the like, by which a feed of the plunger 29 and / or fixing or contact element 25, 26 is controlled or regulated. In particular, a specific value of the path or the number of fleas Fl corresponds to a specific volume of the receiving chamber 27.

[0239] The force F, for example, is the force already described that is exerted on the sealing element 24 to deform it, or a corresponding quantity such as the applied pressure and / or the frictional force occurring during the relative movement between the sealing element 24 and the boundary of the receiving space 27 or the central element 30. A specific deformation or deformation value of the sealing element 24 preferably corresponds to a specific force required to achieve this deformation or deformation value, and / or to a specific height H of the receiving space 27 or a correlated quantity at which this deformation or deformation value is achieved. In particular, the deformation value can therefore be determined using the force and / or the height H.

[0240] Figure 5A shows two different forces F1 and F2 and their corresponding displacements and heights H1 and H2 as examples. The displacement and height H is preferably correlated with the distance traveled and the position of the plunger 29, which deforms the sealing element 24.

[0241] Figure 5A is explained below "from right to left," i.e., starting with large values ​​of H. The force-displacement curve begins at the value D for the height H, where D is the height of the undeformed sealing element 24, in particular the axial height or cross-sectional height of an annular sealing element 24, and most preferably the cord thickness of a torus-shaped sealing element 24, as shown, for example, in Figure 5B. At this point, the fixing element 25 or contact element 26 contacts the still undeformed sealing element 24, as shown, for example, in Figure 4B. At this point, the force F has the value zero, since no deformation has yet occurred or force is exerted on the sealing element 24.

[0242] Initially, only a small force is preferably required to deform or (elastically) deform the sealing element 24. As the deformation increases, the force initially rises slightly, as shown in Fig. 5A. This is evident from the slight increase in force F from point H=D to point H=H1. Smaller values ​​of H correspond to a greater deformation of the sealing element 24, since with smaller values ​​of H and corresponding axial movement of the plunger 29 towards the sealing element 24 and / or receiving space 27, the volume of the receiving space 27 is reduced, and consequently the sealing element 24 is pressed further or more firmly into the receiving space 27 and deforms in the process.

[0243] Due to the elasticity of the sealing element 24, the force required for a simple change in shape or deformation is relatively small. As the height H decreases, the volume of the receiving space 27 decreases, and thus the degree of filling decreases, i.e., the ratio between the volume of the sealing element 24 and the receiving space 27. The force F increases with decreasing height H or decreasing volume of the receiving space 27.

[0244] In particular, as the height H decreases further, compression of the sealing element 24 begins, as already explained. When compression begins, the slope of the force-displacement curve increases, since a greater force is required to compress the sealing element 24 than for a simple change in shape.

[0245] The deformation, in particular the onset of compression, can therefore be read or determined from the force-displacement curve or its course, especially its slope and / or curvature.

[0246] In particular, the slope and / or curvature of the force-displacement curve changes when the sealing element 24 undergoes volume compression. In the illustration shown in Fig. 5A, this occurs especially between the positions H1 and H2 indicated there, or between the values ​​F1 and F2. If the height H is reduced further, volume compression essentially or predominantly takes place. This requires a high force, so that high forces F are reached in the left region of Fig. 5A, and the force-displacement curve has a high slope or rises steeply (towards smaller values ​​of H).

[0247] The onset of volume compression preferably corresponds to the most pronounced curvature of the force-displacement curve. At the onset of volume compression, the force-displacement curve may also exhibit a kink or similar feature. In particular, the onset of volume compression can therefore be reliably and accurately determined by deriving the force-displacement curve, for example, by observing that the derivative of the force-displacement curve shows a discontinuity or other significant change in its shape at the onset of volume compression.

[0248] Preferably, the assembly parameter M is determined using the force-displacement curve, or it is established when a volume compression of the sealing element 24 begins, or a specific characteristic value K is determined at which the volume compression of the sealing element 24 begins or which correlates with the onset of volume compression.

[0249] In other words, the specific characteristic value K is in particular the value of the characteristic value at which the volume compression of the sealing element 24 begins.

[0250] As explained above, volume compression begins particularly at the point where the force-displacement curve exhibits the strongest curvature and / or a kink. The specific characteristic value K therefore preferably corresponds to the force at which the force-displacement curve exhibits the (at least substantially) strongest curvature and / or a kink, and, in the illustration shown in Fig. 5A, correlates with a desired or preferred height HM during assembly, which in turn correlates with the desired assembly parameter M. Different sealing elements 24 or batches of sealing elements 24 may exhibit different force-displacement curve profiles and thus different specific characteristic values ​​K, height HM, and assembly parameter M.

[0251] The assembly parameter M is preferably selected or determined such that it corresponds to an onset of volume compression of the sealing element 24. As explained above, the assembly parameter M is therefore preferably selected such that the height of the receiving chamber 27 in the fully assembled dispensing device 1 corresponds at least substantially to the height HM at which the force-displacement curve exhibits the strongest curvature and / or a kink. In particular, the assembly parameter M corresponds to the height HM of the receiving chamber 27 at which the volume of the (deformed) sealing element 24 corresponds to the volume of the receiving chamber 27, or at which a fill level of at least substantially 100% is reached. However, the assembly parameter M can also be selected or determined such that it leads to a different deformation or...a different deformation value of the sealing element 24 corresponds, for example, to a deformation value at which volume compression has not yet begun or at which the sealing element 24 is not yet compressed and / or at which the sealing element 24 is only or at least predominantly elastically deformed. Preferably, a defined difference can be selected between the deformation value corresponding to the assembly parameter M and the deformation value corresponding to the onset of volume compression. Likewise, it is possible to select or determine the assembly parameter M such that it corresponds to a deformation or deformation value of the sealing element 24 at which volume compression has already begun or the sealing element 24 is already compressed.

[0252] The assembly parameter M can therefore also correspond to other fill levels than 100%, for example, an (arbitrary) fill level of more than 95% and / or less than 105%. Depending on the material of the sealing element 24, this can be advantageous or lead to a better seal and / or service life than a fill level of 100%.

[0253] Preferably, for each batch, a sample is taken to determine the conditions under which the deformation value reaches or exceeds a desired threshold, or at which specific characteristic value K, particularly at which force in the force-displacement curve. Subsequently, the assembly parameter M is selected such that the deformation value reaches or exceeds the threshold when a sealing element 24 of the batch is assembled. The assembly parameter M therefore corresponds in particular to the corresponding fleas FIM or the specific characteristic value K. The selection of the assembly parameter M is preferably achieved by considering the position in which the fixing element 25 is attached to the guide element 23.When the assembly element 26 is fixed in a position, the same volume of the receiving space 27 is achieved as is the case when, during the determination of the assembly parameter M by means of the deformation of the plunger 29, the deformation value corresponds to the threshold value or the deformation value reaches the threshold value. In other words, the assembly parameter M is preferably selected such that the volume (and thus, in particular, the volume) of the receiving space 27 of the fully assembled dispensing device 1 has the same value as the displacement FIM in the force-displacement curve that corresponds to the specific characteristic value K.

[0254] To determine the assembly parameter M, the deformation value to which the selected or determined assembly parameter M corresponds is preferably exceeded. For example, the value F2 shown in Fig. 5A can be the maximum force exerted on the sealing element 24 when determining the assembly parameter M, and the assembly parameter M shown in Fig. 5A can be the selected or determined assembly parameter M. Preferably, to determine the assembly parameter M, the force-displacement curve is traversed beyond a height H to which the assembly parameter M corresponds. This is particularly necessary because the sharpest curvature or slope can only be reliably determined once the point of sharpest curvature or slope has already been passed.

[0255] In the batch process described above, the assembly parameter M for a batch of sealing elements 24 is first determined in a separate process, in particular on the basis of a sample, and then used in the assembly of the sealing elements 24 of the batch.

[0256] However, separating the steps of determining the assembly parameter M and the actual assembly of a dispensing device 1 is not absolutely necessary.

[0257] According to a further aspect, which can also be implemented independently and is described below, the present invention also relates to a method for assembling dispensing devices 1, in which an assembly parameter M is first determined for a sealing element 24 and the sealing element 24 is fixed in the receiving space 27 immediately after the determination of the assembly parameter M, or wherein the assembly of the dispensing device 1 takes place immediately after the determination of the assembly parameter M. In contrast to the batch process described above, the sealing element 24 is preferably fixed or secured in the dispensing device 1 or the receiving space 27 in which the determination of the assembly parameter M also takes place. In particular, the determination of the assembly parameter M and the assembly of the dispensing device 1 take place immediately one after the other and / or in the same system. This method is referred to in particular as an individual process.The individual method is particularly advantageous when, during the assembly of dispensing devices 1, especially in automated or serial production, work is to be carried out without a prior determination of an assembly parameter M. This can be the case, in particular, if the sealing elements 24 of a batch or their significant dimensions differ too greatly from one another. In this case, it may not be possible to determine a common assembly parameter M for all sealing elements 24 of the batch, or a reliable seal or sealing effect may not be ensured by determining a single assembly parameter M for all sealing elements 24 of the batch.

[0258] Nevertheless, the individual procedure described in more detail below is also generally applicable if the sealing elements 24 are available in batches and the sealing elements 24 of a batch differ so little from each other that the batch procedure would also be applicable in principle.

[0259] The determination of the assembly parameter M in the individual process is preferably carried out - at least essentially - as described above for the batch process in connection with Figs. 4A-E and 5, in particular on the basis of determining the deformation behavior and / or friction behavior of the sealing element 24 during a deformation in the receiving space 27 or on the basis of the course of a force-displacement curve.

[0260] The preceding statements regarding the determination of the assembly parameter M therefore preferably also apply to the individual procedure.

[0261] In contrast to the plunger 29 shown in Fig. 4A-D, which is used in the batch process, in the individual process the plunger 29 preferably does not have a central element 30 or the plunger 29 is not passed through the contact element 26 and / or the sealing element 24.

[0262] Preferably, however, instead of the central element 30, the conveying element 9 is already guided through the mounting element 26 and / or the sealing element 24 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, the preceding statements regarding the central element 30 preferably apply analogously to the method in which the conveying element 9 is used instead of the central element 30.

[0263] As described in the batch process, the sealing element 24 is also deformed in the individual process for determining the assembly parameter M. During the determination of the assembly parameter M, the desired deformation of the sealing element 24, or the desired deformation value of the sealing element 24, is exceeded. Accordingly, after the determination of the assembly parameter M has been carried out or is completed, the plunger, and thus the fixing element 25 or the contact element 26, is preferably moved back a short distance, i.e., in particular in the direction of the fixing element 25 or the contact element 26 away from the sealing element 24. In particular, this positions the fixing element 25 or the contact element 26 so that the assembly parameter M is realized, or the position of the fixing element 25 and / or the contact element 26 corresponds to the determined assembly parameter M. This ensures that the sealing element 24 assumes the desired deformation value.The desired deformation value is achieved.

[0264] In this position, the fixing element 25, the contact element 26, or the sealing element 24 is preferably fixed, in particular by fixing or attaching the fixing element 25 to the guide element 23 or guide section 23a and / or the contact element 26. The fixing element 25 is preferably attached as described above, for example by crimping.

[0265] In particular, in the individual process, the fixing or assembly of the sealing element 24 or the dispensing device 1 takes place immediately after the determination of the assembly parameter M and / or in the same system as the determination of the assembly parameter M.

[0266] In contrast to the batch process, in the individual process the fixing element 25 is preferably already guided during the determination of the assembly parameter M. When the fixing element 25 and the contact element 26 are designed as separate parts, as shown in the figures, in the batch process, as explained above, preferably only the contact element 26 is inserted into the receiving space 27 or the sealing element 24 is only deformed with the contact element 26. In the individual process, however, the fixing element 25 is preferably already guided during the determination of the assembly parameter M or the deformation of the sealing element 24 by means of the contact element 26, so that immediately after the determination of the assembly parameter M and / or correct positioning of the contact element 26 and / or fixing element 25, the fixing element 25 can be fixed in this position or attached to the guide element 23.

[0267] A “medicinal product” within the meaning of the present invention is a substance or a preparation of substances intended for use in or on the human or animal body and intended as a means with properties for curing, alleviating, or preventing human or animal diseases or pathological conditions, or which can be applied to or administered to a human or animal body in order to either restore, correct, or modify physiological functions by means of a pharmacological, immunological, or metabolic action, or to establish a medical diagnosis.

[0268] A "assembly parameter" within the meaning of the present invention is preferably an adjustable and / or geometric value that is specified and / or must be adhered to during the assembly of the dispensing device, or that is to be realized or is realized in the fully assembled dispensing device. Preferably, the assembly parameter can be variably specified in the settings of an assembly sequence. Preferably, the assembly parameter is a geometric parameter, in particular a position of a component, preferably relative, or a dimension, such as the height of the receiving space of the dispensing device. In particular, the assembly parameter is a position of a fixing element relative to a guide element, wherein the sealing element is fixed in the guide element or a receiving space of the guide element by means of the fixing element. In other words, this position is preferably defined by the assembly parameter or its value.It is also possible that the assembly parameter only indirectly corresponds to a position of the fixing element or mounting element, for example, by defining or forming the assembly parameter through a delivery path traversed by a part of a device for mounting the dispensing device or for attaching the fixing element to the guide element, or the like.

[0269] A "deformation value" within the meaning of the present invention is preferably a measure of the degree to which the sealing element is deformed, in particular compressed. Specifically, the deformation value is a value that corresponds to or indicates a deformation of the sealing element. The deformation value can, for example, be determined, calculated, and / or derived from one or more measured values ​​or characteristic values. The deformation value preferably indicates whether and / or to what extent the sealing element is (elastically) deformed and / or compressed. In particular, the deformation value is a (temporary) property or a temporary state of the sealing element that cannot be directly measured or determined, but is preferably determined, calculated, or derived from a measured characteristic value.

[0270] A "threshold" within the meaning of the present invention is preferably a value or limit value used to select or determine the assembly parameter. The threshold value is, in particular, a specific value or limit value of the deformation value. The assembly parameter is preferably selected or determined such that, upon fixing the sealing element, the deformation value reaches or exceeds the threshold value. Preferably, the threshold value is predetermined or predeterminable. Preferably, the threshold value corresponds to the onset of volume compression of the sealing element, or the threshold value is the value of the deformation value at which volume compression of the sealing element begins. Depending on the material of the sealing element, however, it may also be desirable or advantageous to select a threshold value that is specifically above or below the value at which volume compression begins.

[0271] A "characteristic value" within the meaning of the present invention is preferably a value that is determined or measured in order to determine, calculate, and / or derive the deformation value. The characteristic value can, for example, be a force (especially a compressive force or a frictional force), a pressure, or a position, particularly a measured force. In particular, the characteristic value is therefore a measured value from which conclusions about the deformation value can be drawn.

[0272] A "compression set" within the meaning of the present invention is preferably a material property of a material from which a sealing element is manufactured. In particular, the compression set is a measure of how the material, especially an elastomer, behaves under prolonged and / or constant compression and preferably subsequent relaxation. The compression set is preferably determined according to DIN ISO 815-1:2016-09. Preferably, to determine the compression set, a cylindrical test specimen is compressed, in particular by 25%, and stored at a specific temperature for a specific period of time. After unloading, preferably 30 minutes after unloading, the permanent deformation of the test specimen is determined by comparing its height before compression with its height after unloading.Specifically, a compression set of 0% means that the specimen has fully recovered its original height. A compression set of 100% means that the specimen was completely deformed during the test and shows no recovery. Specifically, the compression set is the quotient (L0 - L2) / (L0 - L1), where L0 is the height of the specimen before the test, L1 is the height of the specimen during the test, and L2 is the height of the specimen after the test.

[0273] The "creep behavior" or "creep" of a material or sealing element within the meaning of the present invention is, in particular, the behavior of the material or sealing element under a constant load. Specifically, creep behavior is a time- and / or temperature-dependent plastic deformation under a constant load. Creep behavior is determined or characterized, in particular, by the creep modulus.

[0274] A “fixation” of a sealing element in a receiving space within the meaning of the present invention is in particular a fixing or securing of the sealing element in the receiving space in such a way that the sealing element does not deform or cannot deform further in the receiving space.

[0275] The aspects and characteristics described above can be implemented independently or in various combinations. In particular, the batch process and the individual process can be combined. In other words, steps described in connection with the batch process can also be steps in the individual process, and vice versa.

[0276] Reference numeral list: Dispensing device 26b Drug stop 26c Inlet section Container 27 Fluid chamber 27a Pressure generator base 28 Feed channel Bracket 29 Plunger Drive spring 30 Central element Locking element 31 Positioning device a Release button 31a Helix structure Conveyor element 31b Detent elements 0 Check valve 1 Pressure chamber A Axis 2 Discharge nozzle B Width 3 Mouthpiece D Cord diameter 4 Aerosol F Force 5 Air inlet K Specific characteristic 6 (Upper) Housing part H Height 7 Inner part HM Height for mounting 7a Upper part (Inner part) M Mounting parameter 7b Lower part (Inner part) 8 (Lower) Housing part 9 Retaining element 0 Spring 1 Container base 2 Piercing element 3 Guide element 3a Mounting section 3b Channel 3c Recess 4 Sealing element 4a Opening 5 Fixing element 5a Counter surface 6 Contact element 6a Contact section 26a

Claims

Patent claims:

1. Method for assembling dispensing devices (1 ) for dispensing a medicinal product (2), wherein a preferably annular sealing element (24) is arranged in a receiving chamber (27), in particular a dispensing device (1), characterized in that the sealing element (24) arranged in the receiving chamber (27) is deformed and an assembly parameter (M) is determined based on the deformation behavior and / or friction behavior of the sealing element (24) during the deformation, wherein the sealing element (24) or another sealing element (24) to be assembled is fixed in a receiving chamber (27) of a dispensing device (1 ) using the assembly parameter (M).

2. Method according to claim 1, characterized in that several sealing elements (24) are available in batches and for each batch a mounting parameter (M) is determined separately on the basis of a sample of sealing elements (24) of the respective batch, wherein the mounting parameter (M) determined for this batch is used for each fixing of a sealing element (24) of this batch in a receiving space (27).

3. Method according to claim 2, characterized in that the assembly parameter (M) is selected in such a way that the same deformation value of the sealing element (24) results for different batches of sealing elements (24) in fully assembled dispensing devices (1), preferably wherein the deformation value is a measure of how much the sealing element (24) is deformed, in particular compressed.

4. Method according to claim 2 or 3, characterized in that, to determine the assembly parameter (M) of a batch, an assembly parameter (M) is first determined separately for each sealing element (24) of the sample and an average value of these separately determined assembly parameters (M) is set as the assembly parameter (M) for all sealing elements (24) of this batch.

5. Method according to one of claims 2 to 4, characterized in that, to determine the assembly parameter (M), a central element (30) is guided through an opening (24a) of the sealing element (24) or through the receiving space (27), wherein the volume of the receiving space (27) is reduced or limited by the central element (30).

6. Method according to one of claims 2 to 5, characterized in that the number of sealing elements (24) of the sample is less than 50‰, preferably less than 20‰, in particular less than 10‰, particularly preferably less than 5‰, most preferably less than 2‰, of the number of sealing elements (24) of the batch and / or that the volumes of the sealing elements (24) of a batch deviate by less than 10%, preferably less than 5%, particularly preferably less than 4%, from the mean volume of the sealing elements (24) of the batch.

7. Method according to claim 1, characterized in that the sealing element (24) is finally fixed in the receiving space (27) immediately after deformation and determination of the assembly parameter (M) by means of a fixing element (25) or attachment element (26) acting on the sealing element (24).

8. Method according to claim 1 or 7, characterized in that the assembly parameter (M) is determined separately for each sealing element (24) to be mounted and is used only when fixing the sealing element (24) for which it was determined.

9. Method according to one of the preceding claims, wherein the assembly parameter (M) is a value, in particular adjustable and / or geometric, which is specified and / or realized during the assembly of the dispensing device (1), preferably wherein the assembly parameter (M) is preferably variably predefinable in the settings of an assembly process.

10. Method according to one of the preceding claims, characterized in that the assembly parameter (M) represents a, in particular axial, position of a fixing element (25) or mounting element (26) relative to the receiving space (27) or a guide element (23) of the dispensing device (1), or this position is defined by the assembly parameter (M), in particular wherein the guide element (23) at least partially delimits the receiving space (27) and the The fixing element (25) or mounting element (26) is used to fix the sealing element (24) in the receiving space (27).

11. Method according to one of the preceding claims, characterized in that the assembly parameter (M) corresponds to a volume of the receiving space (27) and / or to a deformation value, in particular an onset of volume compression, of the sealing element (24).

12. A method according to one of the preceding claims, characterized in that the assembly parameter (M) is selected or determined such that, in the event of a Fixing the sealing element (24) in the receiving space (27) a deformation value corresponding to a deformation of the sealing element (24) reaches or exceeds a threshold value, preferably wherein the deformation value is a measure of how much the sealing element (24) is deformed, and the threshold value corresponds to an onset of volume compression of the sealing element (24).

13. Method according to one of the preceding claims, characterized in that, to determine the deformation behavior and / or friction behavior of the respective sealing element (24) at different deformations, a characteristic value is measured which corresponds to a deformation value of the sealing element (24) and / or from which the deformation value of the sealing element (24) can be calculated, determined and / or derived.

14. Method according to claim 12, characterized in that the characteristic value is a force, in particular a frictional force or a pressure force, a pressure or a Position is.

15. Method according to one of the preceding claims, characterized in that, in order to determine the deformation behavior of the respective sealing element (24) at different deformations, the force required for deformation is determined in each case.

16. Method according to one of the preceding claims, characterized in that, to determine the frictional behavior of the respective sealing element (24), a boundary of the receiving space (27) and the sealing element (24) are moved relative to each other and, at different deformations, the frictional force between the sealing element (24) and the boundary is determined.

17. Method according to one of the preceding claims, characterized in that a force-displacement curve is recorded to determine the deformation behavior or friction behavior and / or to determine the assembly parameter (M), preferably wherein the assembly parameter (M) is determined based on the course or curvature of the force-displacement curve.

18. Method according to one of the preceding claims, characterized in that the sealing element (24) is designed to seal a conveying element (9) for conveying the medicinal product (2) against a guide element (23) having or forming the receiving space (27) in which the conveying element (9) is guided.

19. Dispensing device (1) for dispensing a medicinal product (2), comprising a conveying element (9) that is in particular axially movable for conveying the medicinal product (2), a guide element (23) for guiding the conveying element (9), and a sealing element (24) that is in particular annular in shape for sealing the conveying element (9) against the guide element (23), wherein the guide element (23) at least partially delimits a receiving space (27) for receiving the sealing element (24), and the sealing element (24) can be fixed in the receiving space (27) by means of a fixing element (25) or contact element (26) that can be attached to the guide element (23), characterized in that the fixing or contact element (25, 26) can be attached to the guide element (23) in various axial and / or discrete positions relative to the guide element (23), and thereby the sealing element (24) can be fixed with a previously determined assembly parameter (M). 20.Dispensing device according to claim 19, characterized in that the various discrete positions are defined by the geometric shape of the guide element (23), the fixing element (25) and / or the contact element (26).

21. Dispensing device according to claim 19 or 20, characterized in that the fixing or contact element (25, 26) can be engaged in various axial and / or discrete positions relative to the guide element (23), in particular on the guide element (23).

22. Dispensing device according to one of claims 19 to 21, characterized in that the fixing or attachment element (25, 26) and / or the guide element (23) has or have a positioning device (31) for positioning the fixing or attachment element (25, 26) relative to the guide element (23).

23. Dispensing device according to claim 22, characterized in that the positioning device (31) has or is formed by one or more locking elements (31b).

24. Dispensing device according to claim 22 or 23, characterized in that the positioning device (31) has or is formed by an inclined plane or helical structure (31a).

25. Dispensing device according to any one of claims 22 to 24, characterized in that the positioning device (31) is arranged at the end face of the fixing or positioning element (25, 26) and / or at the end face of the guide element (23).

26. Dispensing device according to one of claims 19 to 25, characterized in that the rotational position of the fixing or positioning element (25, 26), in particular relative to the guide element (23) or the dispensing device (1), determines the axial position of the fixing or positioning element (25, 26).

27. Dispensing device according to one of claims 19 to 26, characterized in that the position of the fixing or attachment element (25, 26) causes a deformation of the sealing element (24) and / or a size of the receiving space (27) is defined, such that the deformation of the sealing element (24) and / or the size of the receiving space (27) can be varied by varying the position of the fixing element (25) or attachment element (26).

28. Dispensing device according to any one of claims 19 to 27, characterized in that the fixing or positioning element (25, 26) can be moved to a different extent into the receiving space (27) before being fixed in the desired position.

29. Dispensing device according to any one of claims 19 to 28, characterized in that the sealing element (24) is a sealing ring and / or a separate component that can be inserted into the receiving space (27), preferably wherein the sealing element (24) consists of an elastic material with a modulus of elasticity of less than 100 MPa, preferably less than 50 MPa, and in particular less than 10 MPa.

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