METHOD FOR ASSEMBLING DISPENSING DEVICES AND DISPENSING DEVICE

Description

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

[0002] In particular, the present invention relates to the arrangement or assembly of a sealing element in a receiving space of the dispensing device associated with the sealing element. The sealing element preferably serves to seal a conveying element for conveying a medicament from a container of the dispensing device. For this purpose, the sealing element in the fully assembled dispensing device lies sealingly against the conveying element. The conveying element is preferably movable relative to the sealing element. In particular, the conveying element is moved relative to the sealing element to convey the medicament.

[0003] 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.

[0004] Achieving a reliable seal in both static conditions, where the sealing element is stationary relative to the conveying element, and dynamic conditions, where the conveying element is moving relative to the sealing element, can present different, even conflicting, requirements. A particularly effective static seal can be achieved by ensuring 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 to move the conveying element relative to the sealing element, or even slower movement of the conveying element.

[0005] Furthermore, for a good static seal, 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 stroke 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, with each component forming a groove-shaped receiving space for the sealing element, and the different groups of components varying 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 process requires increased storage space for the different batches of sealing elements and the various groups of components. Furthermore, the process is not flexible enough to be used with different sealing materials.

[0009] 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 the dispensing of a medicinal product.

[0010] The above object is achieved by a method according to claim 1 or a dispensing device according to claim 19. Advantageous further developments are the subject of the subclaims.

[0011] According to the proposal, a sealing element is or will be installed in a dispensing chamber of a dispensing device with a previously determined assembly parameter.

[0012] The assembly parameter can be determined individually for each sealing element or randomly for a batch of sealing elements.

[0013] 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. For this purpose, the test facility preferably has a receiving chamber which, in particular, has the same dimensions as the receiving chamber of the dispensing device.

[0014] In particular, the present invention relates to a method for assembling dispensing devices for dispensing a medicament and to a dispensing device for dispensing a medicament, wherein a sealing element with the specific assembly parameter is arranged and fixed in the receiving space of the dispensing device.

[0015] Preferably, the sealing element arranged in the receiving space of a dispensing device or testing 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.

[0016] After determining the assembly parameter, the sealing element or another sealing element to be assembled is fixed in the receiving space of a dispensing device using the assembly parameter.

[0017] 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.

[0018] 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 manufacture or assembly of a large number of dispensing devices, especially in an automated process.

[0019] 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 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.

[0020] Preferably, several sealing elements are present in batches. Preferably, an assembly parameter is determined separately for each batch based on a sample of sealing elements from that batch. This assembly parameter determined for the batch is preferably used each time a sealing element from the batch is fixed in a receiving space.

[0021] Preferably, the assembly parameter for a batch is determined separately or independently, in particular temporally and / or spatially separated, from the assembly of sealing elements or dispensing devices, preferably in a different facility than the assembly of sealing elements or dispensing devices. In other words, the assembly parameter is determined and the assembly of dispensing devices is preferably carried out separately from one another. This method is also referred to below as the "batch method."

[0022] The assembly parameter is preferably selected such that the same deformation value of the sealing element in the receiving space results for different batches or regardless of the batch of fully assembled dispensing devices. The deformation value is, in particular, a measure of the degree to which 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 production or assembly of a large number of dispensing devices, especially in an automated process.

[0023] During assembly, the deformation value is preferably adjusted by means of a position, particularly an axial position, of a fixing element or contact element with which the sealing element is deformed. In particular, a specific deformation value of the sealing element is thus achieved by means of the assembly parameter.

[0024] To determine the assembly parameter of a batch, an assembly parameter is preferably first determined separately for each sealing element in the sample, and an average of these assembly parameters determined separately or for individual sealing elements is defined 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 of several assembly parameters. This makes it easy to consider or compensate for manufacturing tolerances as well as size and / or material differences of sealing elements, ensuring a reliable seal or sealing effect. This contributes to consistent quality in the manufacture or assembly of a large number of dispensing devices, particularly in an automated process.

[0025] 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.

[0026] 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. The use of the central element offers the advantage that the deformation of the sealing element during the determination of the assembly parameter corresponds to a deformation that the sealing element has in the fully assembled dispensing device, without the conveyor element having to be already installed when the assembly parameter is determined. The use of the central element therefore contributes to a simple and permissible determination of the assembly parameter and / or ensures a reliable seal or sealing effect. Furthermore, the use of the central element makes it possible to determine the assembly parameter independently of the assembly of the sealing element or before the assembly of the sealing element and / or in a different system than the assembly of the sealing element.This is beneficial for an optimal process when determining the assembly parameters and / or assembling the sealing element, especially in an automated process.

[0027] It is preferred that a diameter of the central element corresponds to a diameter of a conveying element of the dispensing device, which is designed to convey medicaments, in particular from a container of the dispensing device, and / or which is assigned to or connected to a discharge device of the dispensing device for generating an aerosol. This promotes reliable sealing and / or a sealing effect.

[0028] The number of sealing elements in the sample is preferably 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 in the batch. This allows for minimal effort in determining the assembly parameter or a quick and efficient determination of the assembly parameter.

[0029] Alternatively or additionally, the volumes of the sealing elements in a batch preferably deviate by less than 10%, in particular less than 5%, particularly preferably less than 4%, from the target volume or average volume of the sealing elements in the batch. This promotes consistent quality in the manufacture or assembly of a large number of dispensing devices, particularly in an automated process.

[0030] The features explained above related in particular to a process, also referred to below as a "batch process", in which the sealing elements are manufactured or are present in batches and, for each batch, an assembly parameter is initially determined on the basis of a sample, this assembly parameter being later used for the assembly of each sealing element of the batch.

[0031] 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 the determined assembly parameter. This is particularly independent of whether the sealing elements are available or were manufactured in batches and / or whether the individual sealing elements differ significantly from one another. The method explained below, which will also be referred to as the "individual method" in the following, is therefore particularly advantageous when individual sealing elements differ significantly from one another, but can also be implemented for any sealing elements, especially those that are very similar within a batch.

[0032] 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.

[0033] 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.

[0034] The aspects explained in more detail below apply preferably to both the method in which the assembly parameters for all sealing elements of a batch are first determined on the basis of 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).

[0035] It is preferred that the assembly parameter represents or corresponds to a position, in particular an axial position, of a fixing element and / or abutment element relative to a guide element of a dispensing device, or that the (relative) position of the fixing element and / or abutment element is defined or fixed by the assembly parameter. In this case, the guide element preferably comprises the receiving space or forms it, at least partially. Furthermore, the receiving space is preferably delimited by the fixing element or abutment element.

[0036] Preferably, the fixing element or contact element is designed to fix the sealing element in the receiving space, or the fixing element or contact element fixes the sealing element in the receiving space. Particularly preferably, the contact element is arranged or can be arranged between the sealing element and the fixing element, wherein the contact element directly contacts the sealing element and fixes it in the receiving space. The contact element is preferably fixed or can be fixed by means of the fixing element. In particular, the contact element is directly fixed by means of the fixing element, and thus indirectly fixes the sealing element in the receiving space. Alternatively, the contact element can also be formed integrally with the fixing element. This makes it easy to take manufacturing tolerances as well as size and / or material differences of sealing elements into account or compensate for, and to ensure reliable sealing or a sealing effect.This contributes to consistent quality in the manufacture or assembly of a large number of dispensing devices, especially in an automated process.

[0037] Different assembly parameters preferably correspond to different volumes of the receiving space or to different differences between the volumes of the sealing element and the receiving space. The assembly parameters therefore allow the volume of the receiving space to be adjusted or varied, allowing manufacturing tolerances as well as size and / or material differences of the sealing elements and / or the receiving space to be compensated. This contributes to reliable sealing and / or sealing effectiveness and consistent quality in the production of a variety of dispensing devices, particularly in an automated process.

[0038] 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, which differ, for example, in their external shape and / or the material from which they are made. The threshold value is preferably predetermined or can be predetermined. In this way, a reliable seal or sealing effect, and thus consistent quality, can be achieved in the production of a variety of dispensing devices in a simple manner. Furthermore, the method is adaptable to different sealing elements and can therefore be used flexibly.

[0039] The deformation value is preferably a measure of how strongly the sealing element is deformed. During deformation of the sealing element in the, in particular annular, receiving space, for example by a plunger, a deformation of the sealing element, in particular an elastic deformation, preferably initially occurs. During the deformation, the volume of the sealing element preferably remains at least approximately constant and at least substantially only the outer geometric shape of the sealing element changes. During this deformation or deformation of the sealing element, the shape of the sealing element adapts to the shape of the receiving space and visibly fills it further. This continues until the sealing element at least approximately completely fills the receiving space and / or the shape of the sealing element at least approximately corresponds to the shape of the receiving space.

[0040] If the sealing element is further deformed or compressed, or pressed into the receiving space, volume compression of the sealing element preferably sets in. During volume compression, the volume of the sealing element decreases—in contrast to (elastic) deformation.

[0041] In summary, the behavior of the sealing element during deformation in the receiving space can be divided at least approximately into two phases, with the first phase essentially involving deformation at constant volume, while the second phase involves volume compression.

[0042] Of course, it cannot be ruled out that a (slight) volume compression already sets in towards the end of the first phase or during the deformation.

[0043] The aforementioned threshold value or threshold value for the deformation value—i.e., 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 value of the deformation value at which volume compression of the sealing element begins. This ensures reliable sealing. Furthermore, excessive wear or abrasion is avoided. This is beneficial for consistent quality during manufacture or assembly of a variety of dispensing devices, particularly in an automated process.

[0044] Preferably, the sealing element is deformed by moving a plunger and / or the contact or fixing element relative to the sealing element. The plunger can act on the contact or fixing element, thereby indirectly moving the contact or fixing element relative to the sealing element and thus deforming the sealing element via the contact or fixing element. However, it is also possible to act directly on the sealing element with the plunger, thereby deforming the sealing element.

[0045] 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.

[0046] To determine or investigate the deformation behavior of the respective sealing element, the force required for deformation is determined (directly or indirectly) for different deformations or deformation values ​​of the sealing element, in particular measured. 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 in particular a characteristic value from which the deformation value can be determined, calculated or derived. Alternatively, the force causing the deformation can also be specified and the deformation or the feed or axial position of the plunger and / or contact element or fixing element corresponding to the deformation or in particular the height of the receiving space can be determined, in particular measured.

[0047] Alternatively or in addition to determining or investigating the deformation behavior of the sealing element, as already mentioned at the beginning, the friction behavior of the sealing element can also be determined or investigated. 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 one another and, for different deformations or deformation values ​​of the sealing element, the friction force between the sealing element and the boundary is determined, in particular measured. The measured force preferably represents the characteristic value from which the deformation value can be or is determined, calculated or derived. Preferably, the boundary of the receiving space 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 back-and-forth 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.

[0048] At different times during the deformation, the sealing element in the receiving space is preferably deformed to different degrees. The different times therefore preferably correspond to different feed rates or positions of the fixing element or contact element.

[0049] 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 course of the force-displacement curve. This facilitates a simple, rapid, and / or accurate determination of the assembly parameter.

[0050] 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 moved relative to the sealing element.

[0051] The path in the force-path curve is preferably the feed of the ram or fixing element or contact element or the height of the receiving space or a path corresponding thereto.

[0052] The sealing element is preferably designed to seal a conveying element for conveying the medicament against a guide element having or forming the receiving space in which the conveying element is guided.

[0053] Preferably, the sealing element is annular or a shaped seal or a sealing ring, in particular an O-ring.

[0054] The sealing element is preferably a separate component that can be inserted into the receiving space. The sealing element is preferably made 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, in particular less than 10 MPa.

[0055] The sealing elements from different batches can be made of different materials and / or have different deformation properties, different compression sets and / or different creep behavior or different creep moduli. The process, in which an assembly parameter is determined separately for each batch, ensures that a reliable seal or sealing effect is achieved even for such different sealing elements or batches of sealing elements. In particular, the precise adjustment of the volume of the receiving space made possible by this process also allows materials for sealing elements to be used that are partially plastic or have comparatively high creep behavior - such as thermoplastic elastomers (TPE). Such sealing elements require receiving spaces that are particularly precisely designed or adapted to the respective sealing element.

[0056] According to a further aspect, which can also be implemented independently, the present invention relates to a dispensing device for dispensing a medicament. The dispensing device has a conveying element, which is in particular axially movable, for conveying the medicament from a container of the dispensing device, a guide element for guiding the conveying element, and a sealing element, which is in particular annular, for arrangement in a receiving space of the guide element. The sealing element is preferably designed to seal the conveying element against the guide element and in particular as a sealing ring. Furthermore, the sealing element can preferably be fixed in the receiving space by means of a fixing element or contact element which can be fastened to the guide element. Preferably, the guide element forms the pressure chamber of a piston pump, or the guide element has the pressure chamber, wherein the conveying element forms the piston of the piston pump.

[0057] The fixing element or contact element can preferably be fastened to the guide element in various axial positions relative to the guide element. This makes it possible and intended that the sealing element is or will be fixed with an adapted, specific assembly parameter. This makes it easy to consider or compensate for manufacturing tolerances as well as size and / or material differences of sealing elements, ensuring a reliable seal or sealing effect. This contributes to consistent quality in the manufacture or assembly of a variety of dispensing devices, particularly in an automated process.

[0058] 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.

[0059] Alternatively or additionally, the fixing or positioning element and / or the guide element preferably includes a positioning device for positioning the fixing or positioning element relative to the guide element. The positioning device particularly preferably includes or is formed by one or more detent elements, especially detent cams. This facilitates the assembly and / 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, ensuring a reliable seal. This contributes to consistent quality in the manufacture and assembly of a large number of dispensing devices, especially in an automated process.

[0060] 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.

[0061] The positioning device is preferably arranged on the end face of the fixing or mounting element and / or the guide element.

[0062] 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.

[0063] 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, so 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.

[0064] The above and following aspects and features of the present invention can be combined with each other in different combinations, but can also be realized independently of each other.

[0065] Further aspects, features, advantages, and characteristics of the present invention will become apparent from the claims and the following description of preferred embodiments with reference to the drawings. It shows: Fig. 1 shows a schematic section of a dispensing device according to the invention in a first state; Fig. 2 shows a schematic, 90° opposite Fig. 1 rotated section of the dispensing device in a second state; 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; Fig. 4B shows a schematic section through the pressure generator during a second situation when determining the assembly parameter; Fig. 4C shows a schematic section through the pressure generator according to Fig. 4A During the first situation when determining the assembly parameter, the sealing element has a different size than in Fig. 4A Fig. 4 shows a schematic section through the pressure generator according to Fig. 4Cduring the second situation when determining the assembly parameter; Fig. 4E a schematic section through the pressure generator after fixing the sealing element; Fig. 5A a schematic representation of the course of a measured value during a deformation or determination of an assembly parameter; Fig. 5B a schematic section through an undeformed sealing element; Fig. 5C a schematic section through a deformed sealing element; and Fig. 6 a schematic side view of the pressure generator according to a further embodiment.

[0066] 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.

[0067] Fig. 1 and Fig. 2show a proposed dispensing device 1 for dispensing a medicament 2. In particular, the dispensing device 1 is designed as an atomizer or for atomizing the medicament 2. The medicament 2 is preferably a fluid, in particular a liquid.

[0068] Fig. 1 shows the dispensing device 1 in a schematic section in a first state, here in the non-triggering state and Fig. 2 in a second state, here in the ready-to-release state.

[0069] The dispensing device 1 is preferably designed as a portable, portable and / or mobile dispensing device 1.

[0070] When the medicament 2 is atomized by the dispensing device 1, an aerosol 14 is preferably formed, in particular, the aerosol 14 being inhalable or inhalable by a user (not shown). The dispensing device 1 is therefore preferably designed as an inhaler.

[0071] Inhalation is usually carried out at least once a day, in particular several times a day, preferably at predetermined intervals, for example depending on the patient's illness.

[0072] The aerosol 14 is preferably a particle-air mixture with solid and / or liquid particles which are particularly preferably respirable, i.e. in particular at least partially or on average smaller than 5 µm in diameter.

[0073] The dispensing device 1 is preferably propellant-free, i.e., it preferably operates without propellant gas. 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 2, thereby generating the aerosol 14 when it is dispensed from a dispensing nozzle 12. However, the dispensing device 1 can also be driven or operate in other, preferably mechanical, ways.

[0074] The dispensing device 1 has a preferably insertable and preferably replaceable container 3 containing the substance or medicinal product 2. The container 3 preferably forms a reservoir for the medicinal product 2 to be atomized.

[0075] Preferably, the container 3 contains a sufficient amount of medicament 2 to provide, for example, up to 200 dosage units, i.e., to enable, for example, up to 200 nebulizations or applications. A typical container 3, as disclosed in WO 96 / 06011 A2 or WO 00 / 49988 A2, holds a volume of approximately 2 ml to 10 ml.

[0076] The container 3 is preferably at least substantially cylindrical or cartridge-like. In the illustrated example, it can be inserted into the dispensing device 1 from below after opening it, and can be replaced if necessary. However, it can also be non-replaceable, and the dispensing device 1 can be a disposable product.

[0077] 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.

[0078] Preferably, the drug substance 2 is contained in a fluid space 4 formed by a collapsible bag in the container 3.

[0079] The dispensing device 1 preferably further comprises the preferably mechanical pressure generator 5 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.

[0080] The pressure generator 5 preferably has a drive spring 7—only partially shown in the illustrated example—for driving the pressure generator 5. The drive spring 7 is preferably designed to store energy, in particular mechanically, and to deliver it to the pressure generator 5, so that the pressure generator 5 pressurizes the medicament 2, whereby the aerosol 14 is formed from the medicament 2 when discharged from the discharge nozzle 12. The pressure generator 5 is thus driven by the drive spring 7 or the energy provided by the drive spring 7.

[0081] The pressure generator 5 preferably has a holder 6 for the container 3, the associated drive unit, which is only partially shown, in particular in the form of the drive spring 7, as well as a particularly tubular conveying element 9, a check valve 10 and / or a pumping or pressure chamber 11.

[0082] The dispensing device 1 preferably has a locking tensioning mechanism or locking element 8, which is designed to preferably automatically lock the drive spring 7 after energy has been introduced into the drive spring 7. The energy is preferably introduced into the drive spring 7 by stretching, expanding, compressing or, in particular, compressing the drive spring 7. For the sake of simplicity, this will be summarized below under the term "tensioning" of the drive spring 7, and the state of the drive spring 7 achieved thereby will be assigned the attribute "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 held in a higher or lower energy state by the locking element 8, which can in particular be manually actuated.kept in a charged or tensioned state, wherein the energy stored in the drive spring 7 - in particular by tensioning - is released or used to generate pressure in the pressure generator 5 by actuating the locking element 8 (directly or preferably via a release button 8a).

[0083] Preferably the drive spring 7 is a spiral or helical spring, wherein energy is stored or injected by means of axial compression of the drive spring 7.

[0084] Preferably the dispensing device 1 or the pressure generator 5 has a discharge nozzle 12, particularly in the area of ​​an optional mouthpiece 13.

[0085] The container 3 is preferably fixed in the dispensing device 1 or fluidly connected to the conveying element 9 via the holder 6, in particular in a locking manner, 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 removed and replaced.

[0086] When energy is introduced into the drive spring 7 or the drive spring 7 is tensioned, the holder 6 with the container 3 and the conveying element 9 is moved downwards in the illustrations (i.e. in the example shown the drive spring 7 is axially compressed or compressed) and the medicament 2 is sucked from the container 3 via the check valve 10 into the pressure chamber 11 of the pressure generator 5.

[0087] During the subsequent unloading 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 by the drive spring 7 moving the conveying element 9, with its now closed check valve 10, back upwards or into the pressure chamber 11, thereby 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 described in Fig. 1 indicated.

[0088] If the conveying element 9 or the check valve 10 functions as a pressure stamp, a movement of the conveying element 9 or the container 3 corresponds to a volume displaced in the pressure chamber 11 or a discharged or dischargeable amount of medicament.

[0089] 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.

[0090] In the illustrated example, the dispensing device 1 preferably has an upper housing part 16 and an inner part 17 rotatable relative to it (inner housing part) (see figure). Fig. 2 ) with an upper part 17a and a lower part 17b (cf. Fig. 1 ) on. A lower housing part (lower housing part) 18 or a cap, preferably detachably or permanently attached by means of a retaining element 19, is preferably attached to the inner part 17, in particular by means of a retaining element 19.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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 loaded, in particular compressed, via a gear mechanism (not shown) acting on the holder 6. During this tensioning process, the container 3 is preferably moved axially downwards until the container 3 reaches a certain pressure. Fig. 2 The container 3 assumes the indicated end position. In this state, the drive spring 7 is charged, or the dispensing device 1 is ready to dispense. During the atomization process, the container 3 is preferably moved back (upwards) to its initial position by the drive spring 7.

[0095] The container 3 preferably performs an axial movement or lifting movement during the addition of energy or during the clamping process or for fluid withdrawal and / or during the atomization or dispensing of the medicinal product 2.

[0096] Preferably, a ventilation opening of the container 3 is opened upon initial loading or initial tensioning of the drive spring 7. This is preferably done by means of a device that 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 upon initial installation for ventilation.

[0097] Preferably, the piercing element 22 is arranged on an axially acting spring 20, which comes into contact with the bottom of the container 21 during the first loading.

[0098] In Fig. 3 The pressure generator 5 of the dispensing device 1 is shown in more detail, but schematically and not to scale.

[0099] 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 µl, in particular more than 5 µl, and / or less than 1 ml, in particular less than 500 µl, in particular less than 100 µl, most preferably less than 30 µl, and in particular substantially 10 to 20 µl, per piston stroke.

[0100] 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.

[0101] The dispensing device 1 or the pressure generator 5 preferably has an axis A. The axis A preferably corresponds to a principal 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.

[0102] The terms "axial" and "radial" refer in particular to the axis A. An "axial" direction, extension, movement, or the like is therefore preferably parallel to the axis A, and a "radial" direction, extension, movement, or the like is preferably radial to the axis A.

[0103] 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 space 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 space 27.

[0104] In the (fully assembled) dispensing device 1, the sealing element 24 is arranged in the receiving chamber 27.

[0105] 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.

[0106] Preferably, the fixing element 25 is designed to fix or secure the sealing element 24 in the receiving space 27.

[0107] 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.

[0108] 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 in Fig. 3 indicated by way of example.

[0109] In the example shown, the fixing element 25 and the contact element 26 are formed by two separate components.

[0110] The two-part design of the fixing element 25 and the contact element 26, for example, has the advantage that the fixing element 25 and the contact element 26 can be better optimized for the respective requirements. For example, a particularly good fit with small tolerances in the receiving space 27 is important for the contact element 26 to reliably ensure good sealing. Therefore, the contact element 26 should have the smallest 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, form-fitting, or force-fitting connection with the pressure generator 5 or guide element 23 or another component - in particular for determining the axial position.

[0111] Furthermore, the contact element 26 and the fixing element 25 can be manufactured from different materials when designed as separate components. For example, the contact element 26 can be made from a more dimensionally stable and / or stiffer or harder material, and / or the fixing element 25 can be made from a softer or more ductile material than the other component. A "more ductile material" is, in particular, a material with greater ductility, where the term "ductility" refers to the property of a material to permanently deform, in particular plastically deform, under shear stress before fracture. Overall, the flexibility in the manufacture and / or use of separate components is increased, and the manufacturing processes can be optimized.

[0112] A further advantage of designing the contact element 26 and the fixing element 25 as separate components is that the requirements placed on the components can be better met by selecting different materials for these components. A harder or more dimensionally stable material for the contact element 26 is preferred because this enables permanent or consistent fixation of the sealing element 24 in the receiving space 27, thus ensuring permanent or consistent sealing 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 deforming attachment of the fixing element 25 to the guide element 23, in particular by pressing or crimping. Overall, therefore, selecting different materials for the contact element 26 and the fixing element 25 is advantageous for meeting the requirements.

[0113] However, it is also possible for the contact element 26 to be formed integrally with the fixing element 25 or vice versa, and / or for the contact element 26 to represent or form a section of the fixing element 25. The integral design results in fewer components, but is only optional.

[0114] 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.

[0115] 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 a part thereof.

[0116] The conveying element 9 preferably defines a pumping chamber or the pressure chamber 11 in the guide element 23, as in Fig. 3 indicated. 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.

[0117] In the illustrated example, the preferably hollow conveying element 9 forms a supply channel 28 for the medicament 2 or has the supply channel 28. With a corresponding axial movement, the medicament 2 can be conveyed, in particular sucked, through the supply channel 28 via the inlet or check valve 10 into the pressure chamber 11.

[0118] On the printing or output side, the printing 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.

[0119] 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 by the conveying element 9 through the feed channel 28 into the pressure chamber 11 or pressurized there and dispensed via the discharge nozzle 12, thereby being applied, preferably atomized, i.e., a spray mist or aerosol 14 is formed from the drug 2, as shown in Fig. 3 indicated.

[0120] In the Fig. 1 The depicted non-triggerable state is pressure chamber 11 compared to the one shown in Fig. 2The actuating element 9 or piston is preferably reduced in size or minimized in the actuating state shown. In other words, in the non-actuating state, the conveying element 9 or piston preferably immerses itself in the pressure chamber 11. In the actuating state, the conveying element 9 or piston is preferably further away from the discharge nozzle 12 and / or withdrawn from the pressure chamber 11 than in the actuating state shown. Fig. 1 depicted non-triggerable state.

[0121] 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.

[0122] It is preferred that the guide element 23 has or forms the receiving space 27 (at least partially) or at least partially delimits it, in particular on the outside and / or on an axial or end face, preferably on the discharge side or facing the pressure chamber 11 and / or discharge nozzle 12.

[0123] 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 the guide element 23 or surrounds it.

[0124] The receiving space 27 is designed in particular as a recess in the guide element 23, particularly preferably as a groove or annular groove, annular shoulder or as a bushing.

[0125] 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 height H of the receiving space 27.

[0126] Preferably, the receiving space 27 is delimited—at least partially—by the guide element 23 and the contact element 26 or fixing element 25. The guide element 23 can form a cylindrical or hollow-cylindrical guide or receptacle for the contact element 26 or fixing element 25.

[0127] Preferably, the receiving space 27 surrounds the conveying element 9 radially and / or annularly.

[0128] The conveying element 9 preferably forms an inner radial boundary of the receiving space 27.

[0129] Preferably, the guide element 23 forms an axial and / or radial outer boundary for the receiving space 27.

[0130] 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.

[0131] The conveying element 9 is preferably made of metal, in particular stainless steel. It is designed, in particular, as a hollow element or capillary.

[0132] The conveying element 9 is preferably drawn and accordingly has a relatively small tolerance with regard to its diameter.

[0133] 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.

[0134] The sealing element 24 is preferably designed to be continuously annular or as a shaped seal or sealing ring, in particular adapted for accommodation in the receiving space 27.

[0135] The sealing element 24 preferably has an opening 24a, in particular a central opening.

[0136] In particular, the sealing element 24 is an O-ring with an at least substantially circular cross-section in the non-installed or non-deformed state, as shown in Fig. 5B However, the sealing element 24 can also be designed as another shaped seal, in particular with a non-circular cross-section in the non-deformed state.

[0137] In its undeformed state, the sealing element 24 preferably has a different cross-section or volume than the receiving space 27 of the (fully assembled) dispensing device 1. Therefore, the sealing element 24 is preferably deformed during assembly of the dispensing device 1, in particular during attachment of the contact element 26 or fixing element 25 to the guide element 23. The deformation of the sealing element 24 creates an elastic prestress in the sealing element 24, which contributes to an optimal sealing effect of the sealing element 24 and / or through which a seal can be achieved by means of the sealing element 24.

[0138] The deformation or deformation value of the sealing element 24 is preferably not directly determinable or adjustable, but is determined in particular by means of a corresponding characteristic value or derived from a characteristic 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.

[0139] 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.

[0140] Particularly preferably, the volumes of the sealing elements 24 of a batch deviate by less than 10%, particularly less than 5%, particularly preferably less than 4% or 2% from the mean volume or target volume of the sealing elements 24 of the batch.

[0141] In a specific example, the sealing elements 24 have a nominal volume or mean volume of more than 5 mm 3< and / or less than 10 mm 3<, particularly preferably about 7 mm 3< to 8 mm 3<, wherein all sealing elements 24 of the batch have a volume that deviates by no more than 0.3 mm 3< from this nominal volume or mean volume.

[0142] 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.

[0143] Preferably, the sealing element 24 is a single part or separate component, particularly in the form of an O-ring or sealing ring. Alternatively, however, the sealing element 24 can also be molded directly 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 therein or thereon, instead of merely sealing elements 24, as explained above.

[0144] The sealing elements 24 can vary from batch to batch, in particular 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 quality), material-related or process-related dimensions such as compressibility can also vary.

[0145] The sealing elements of 24 different batches preferably differ only in manufacturing tolerances that arise from production in different batches.

[0146] However, it is also possible that the sealing elements of different batches differ more significantly from each other, 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 residues.

[0147] The sealing element 24 is preferably designed to seal the conveying element 9 against the guide element 23 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, especially no gas and / or liquid, can escape from the pressure chamber 11 and / or between the guide element 23 and the conveying element 9.

[0148] 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.

[0149] The sealing element 24 is preferably made 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, in particular less than 10 MPa.

[0150] The sealing element 24 is preferably made of a rubber-elastic material or rubber suitable for pharmaceuticals or foodstuffs. The sealing element 24 is preferably made of silicone, fluororubber (FKM), a thermoplastic elastomer (TPE), ethylene-propylene-diene rubber (EPDM), chloroisobutene-isoprene rubber or chlorobutyl rubber (CIIR), bromobutyl rubber (BIIR), polyurethane (PUR), and / or nitrile rubber (NBR).

[0151] Different materials that can be considered for the sealing element 24 have different properties. On the one hand, there are materials that exhibit an increased leak rate and / or reduced diffusion tightness upon contact with a pharmaceutical, at elevated temperature and / or pressure. In other words, it is possible that upon contact with a pharmaceutical or at elevated temperature or pressure, the sealing effect of the sealing element 24 is reduced due to increased diffusion through the sealing element 24.

[0152] With a sealing element 24 made of such a material, static sealing or good bearing tightness is hampered by the fact that 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 extension of the sealing element 24 in the direction of diffusion.

[0153] Furthermore, there are materials in which, at elevated temperature and / or elevated pressure, the contact stress on the sealing surfaces of the sealing element 24 decreases, particularly the surfaces that are in contact with the boundary of the receiving space 27. In other words, creep of the material or sealing element 24 is observed in these materials under elevated pressure and / or elevated temperature.

[0154] In this case, a bearing leak or poor static seal arises in particular because, if the compressive stress of the sealing material or sealing element 24 on the opposite surface, in this case in particular the surface of the conveying element 9, is too low, the roughness or microporosity of the surface leads to a leak.

[0155] The problem with sealing the conveying element 9 by the sealing element 24 therefore lies in particular in meeting two somewhat competing requirements: On the one hand, a high preload pressure or a strong deformation of the sealing element 24 in the receiving space 27 is desirable or advantageous in that it can prevent bearing leaks or improve the static seal. On the other hand, however, a high preload pressure or a strong deformation of the sealing element 24 leads to a deterioration in the dynamic seal, i.e. the seal of the conveying element 9 during a movement of the conveying element 9 relative to the sealing element 24, since an increased preload pressure increases the creep or flow of the material and also increases the abrasion due to the relative movement between the conveying element 9 and the sealing element 24.In addition, excessive preload pressure not only leads to increased abrasion, but also to more difficult operation or movement of the conveying element 9. This can lead to the conveying element 9 not moving at all or not moving as intended, so that, for example, too small a dose of the medicament 2 is dispensed during one conveying stroke and / or insufficient atomization occurs.

[0156] In particular, the deformation value is a measure of how strongly the sealing element 24 is deformed or the relationship between the cross-section or volume of the (deformed) sealing element 24 and the cross-section or volume of the receiving space 27 in the fully assembled dispensing device 1. The deformation value is therefore, in particular, a measure of the strength of the elastic prestress of the sealing element 24 in the receiving space 27.

[0157] In particular, the sealing element 24 should be deformed or the deformation value of the sealing element 24 should be selected or adjusted such that the explained competing requirements are met as optimally as possible, i.e. on the one hand the deformation is sufficiently large that an elastic prestress prevails in the sealing element 24, by which a bearing leak can be avoided, and on the other hand the deformation is sufficiently small that a good dynamic seal is ensured or flow and / or creep of the material is prevented.

[0158] 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 arranged in the receiving chamber 27 or fixed in the receiving chamber 27 with such a preload pressure that both a good static seal and a dynamic seal are achieved. Furthermore, the proposed method is preferably suitable for a variety of materials or different materials.

[0159] In the installed state – i.e., with the pressure generator 5 mounted – the sealing element 24 is at least substantially contained in the receiving chamber 27, as shown in Fig. 3shown. The contact element 26 or fixing element 25 preferably bears axially against the sealing element 24 and fixes the sealing element 24 axially in the receiving space 27. Furthermore, the sealing element 24 preferably bears radially against the conveying element 9, which extends through the sealing element 24. The sealing element 24 is in particular clamped or compressed in the receiving space 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 one flat contact side facing the conveying element 9.

[0160] In order to achieve a good seal and correspondingly accurate dosing, the desired fill level, i.e. the "target fill level", is on average preferably more than 90%, in particular more than 95%, and / or less than 110%, in particular less than 105%, in particular at least substantially 100%, in particular with a tolerance of 4%, 2% or less.

[0161] The "filling level" corresponds to the quotient of the volume of the undeformed sealing element 24 (as particularly in Fig. 5B (represented) by the volume of the receiving space 27. The inventive method and the proposed dispensing device 1 are preferably designed to realize or reproduce this or any other desired fill level.

[0162] The volume of the receiving space 27 is preferably variable and / or adjustable or fixable by or during assembly.

[0163] In the illustrated example, the mounting element 26, 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 mounting element 26, and thus a defined axial length or height H of the receiving space 27 for the sealing element 24, can be achieved by means of corresponding axial or end-face contact surfaces.

[0164] The height H of the receiving space 27 is in particular the (axial) distance between a bottom 27a or the annular surface or shoulder of the receiving space 27 formed by the guide element 23 and the end face of the contact element 26 facing the bottom 27a or sealing element 24 or the end face of a contact section 26a of the contact element 26, as in Fig. 3 indicated.

[0165] Preferably, the fixing element 25 is cap-like and / or it overlaps the contact element 26 at one end face or at the free end.

[0166] The attachment element 26 is preferably at least substantially ring-shaped. Preferably, the attachment 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.

[0167] The contact 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 axial end section of the contact 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 space 27, or the contact section 26a clamps the sealing element 24a in the receiving space 27.

[0168] 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.

[0169] The contact section 26a is preferably annular, in particular circular, in cross-section (i.e. in section perpendicular to the axis A).

[0170] The contact element 26 preferably has a contact 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.

[0171] The fixing element 25 preferably has a counter surface 25a associated with the stop 26b in order to contact the stop 26b or to axially hold or fix the stop 26b and thus the contact element 26.

[0172] The contact element 26 preferably has a particularly conical insertion section 26c, which facilitates the insertion of the conveying element 9 into the contact 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 bevel and / or rounded portion or is formed thereby. In particular, a central opening of the contact element 26 is radially widened or enlarged toward the free end of the contact element 26 by the insertion section 26c or the bevel / rounded portion.

[0173] Preferably, the position, in particular the axial position, of the fixing element 25 is variable. The fixing element 25 can preferably be fastened to the guide element 23 in various, in particular axial, positions relative to the guide element 23. For this purpose, 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.

[0174] In the example illustration according to 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 designed differently, for example, by having or being formed with an adhesive surface.

[0175] Preferably, the fixing element 25 or the mounting 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 mounting element 26 and / or the guide element 23 or mounting section 23a.

[0176] The fixing element 25 can be attached, for example, by screwing or gluing as shown in Fig. 3 indicated or, for example, by deformation, in particular by forming one or more beads, and / or by, in particular, radial engagement preferably in one or more recesses 23c of the guide element 23, as shown in Fig. 4Eindicated, attachable to the guide element 23. In particular, the guide element 23 or the fastening section 23a can have several recesses 23c which are arranged at different axial positions.

[0177] In particular, the plurality of recesses 23c define or realize a plurality of discrete positions of the fixing element 25 or contact element 26 relative to the guide element 23. In other words, the fixing element 25 or contact element 26 can preferably be fastened to the guide element 23 in various discrete positions relative to the guide element 23 through the recesses 23c.

[0178] In particular, the axial position of the fixing element 25 or the contact element 26 and thus the height H and ultimately the volume of the receiving space 27 can be adjusted or varied.

[0179] In other words, it is preferred that in the fully assembled dispensing device 1, the fixing element 25 is fastened in a fixed or defined position to the guide element 23 or the fastening section 23a, or that the fixing element 25 and / or contact element 26 are fixed or secured in a fixed or non-changeable position relative to the guide element 23, wherein, however, when fixing or fastening the fixing element 25 and / or contact element 26, different, in particular axial and / or discrete, positions relative to the guide element 23 can be selected or realized. In particular, 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 can be selected or adapted to the sealing element 24. The variability of the position of the fixing element 25 orThe installation of the contact element 26 during assembly particularly constitutes an independently realizable aspect of the present invention.

[0180] In particular, the position of the fixing element 25 and / or the 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 the attachment element 26.

[0181] 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.

[0182] Preferred methods for fastening the fixing element 25 are screwing the fixing element 25 in place, (positive locking) fastening by means of pins, a forming fastening (for example casting or a material-locking fastening by means of curing resin, in particular by UV-curable resin, and / or an adhesive), a forming fastening (for example crimping or hot riveting), a machining fastening, welding, soldering or the like.

[0183] 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, in particular with a defined torque. Preferably, the threads used here are designed as steep threads and / or are not self-locking. This is exemplified in Fig. 3 indicated.

[0184] 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.

[0185] For this purpose, the guide element 23 can have one or more recesses 23c or be formed thereby. 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 the recesses 23c define different axial and / or discrete positions of the fixing element 25 or contact element 26. This is illustrated by way of example in Fig. 4A-E indicated.

[0186] 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.

[0187] At the Fig. 4A-E In the illustrated embodiment 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.

[0188] 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.

[0189] The fixing element 25 can already be preformed to engage in a recess 23c, for example, by having a peripheral edge or an edge otherwise configured to correspond to the recess 23c for engaging in the recess 23c. However, this is not absolutely necessary. Such a preforming of the fixing element 25 in combination with the recesses 23c also determines a discrete position of the fixing element 25 or contact element 26. It is also possible that the fixing element 25 does not have such a pre-shaping, but 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, for fastening or fixing the fixing element 25, a deformation tool deforms the fixing element 25 into the recess 23c.

[0190] According to a further 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.

[0191] 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 only established after the support element 26 has been positioned.

[0192] In the Fig. 4EIn the embodiment shown, the contact element 26 or its stop 26b has a groove or bead radially on the outside, wherein the fixing element 25 is deformed into this groove or bead by crimping or is fastened to the contact element 26.

[0193] 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 in Fig. 4E in a sectional view of the pressure generator 5, wherein the fixing element 25 is omitted and only the contact element 26 and the guide element 23 are shown.

[0194] According to the Fig. 6In the embodiment shown, the fixing or contact element 25, 26 can preferably be locked into place on the guide element 23 in various axial and / or discrete positions relative to the guide element 23. In particular, various discrete positions of the fixing or contact element 25, 26 relative to the guide element 23 are thereby fixed or can be fixed.

[0195] Preferably, the fixing or contact element 25, 26 and / or the guide element 23 has a positioning device 31 for positioning the fixing or contact element 25, 26 relative to the guide element 23. The positioning device 31 is preferably formed by mutually corresponding surfaces or sections of the contact element 26 and the guide element 23 or has such surfaces.

[0196] The positioning device 31 is preferably arranged on an end face of the contact element 26 assigned to or facing the guide element 23 and / or on an end face of the guide element 23 assigned to or facing the contact element 26.

[0197] In the illustrated example, the positioning device 31 is formed in particular by or comprises one or more helical structures 31a. Preferably, both the contact element 26 and the guide element 23 comprise a helical structure 31a.

[0198] 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.

[0199] However, instead of the helical structure 31a, only an inclined plane or sloping surface or the like may be provided.

[0200] Preferably, the axial position of the fixing element 25 or the contact element 26, particularly relative to the guide element 23, is determined or definable by the rotational position of the fixing element 25 or the contact element 26. This is preferably enabled or realized by the positioning device 31, in particular by the inclined plane or inclined surface or helical structure 31a.

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

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

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

[0204] Particularly preferably, the locking elements 31b are designed such that rotation of the contact 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 shown, by a corresponding design of the locking elements 31B with inclined and vertical surfaces.

[0205] 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, helical 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 clarity only, in Fig. 6 a distance between the contact element 26 and the guide element 23 is shown.

[0206] By means of the positioning device 31, in particular the inclined planes or helical structures 31a and / or locking elements 31b, preferably different discrete positions of the fixing or contact element 25, 26 relative to the guide element 23 are defined. In other words, the fixing element 25 or contact element 26 can be fastened, in particular latched, to the guide element 23 in different discrete positions relative to the guide element 23, preferably by means of the positioning device 31, in particular the inclined planes or helical structures 31a and / or locking elements 31b.

[0207] In the following, particular attention will be paid to proposed methods for assembling the dispensing device 1 or for assembling (a plurality of) dispensing devices 1.

[0208] In particular, an assembly method in which sealing elements 24 are present in batches is first described below. Within a batch, the variance with regard to the significant sizes of the sealing elements 24 is preferably small. In this method, an assembly parameter M is preferably first determined based on a sample of a small quantity of sealing elements 24 of the batch, and this assembly parameter M is then later used for each sealing element 24 during the assembly of the sealing elements 24 of the batch. In particular, the assembly parameter M is thus determined (batch-wise) before or independently of the actual assembly of sealing elements 24. This method is particularly referred to as a batch method.

[0209] 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.

[0210] First, however, we will take a closer look at the batch process.

[0211] 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.

[0212] 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, sealing elements 24, and / or less than 1,000,000, in particular less than 800,000, sealing elements 24.

[0213] The determination of the assembly parameter M is preferably carried out using a sample or subset of sealing elements 24 of the batch.

[0214] The sample comprises, in particular, a small number of sealing elements 24 from the batch, preferably at least 10, preferably at least 50, in particular at least 80 and / or at most 250, preferably at most 150, in particular at most 125. The size of the sample preferably depends on the size of the batch, with larger samples being used for larger batches.

[0215] The sample preferably comprises less than 50%, preferably less than 20%, in particular less than 10%, particularly preferably less than 5%, very particularly preferably less than 2% of the sealing elements 24 of the batch.

[0216] 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 system not shown.

[0217] The receiving space 27 of the test system preferably has the same dimensions as the receiving space 27 of the dispensing device 1. However, for the sake of simplicity, the method is described below using a receiving space 27 of the dispensing device 1.

[0218] Likewise, the system element does not have to be a 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 designed similarly or identically to the system element 26.

[0219] The test system preferably does not have a complete dispensing device 1 or a complete pressure generator 5, but merely a receiving space 27 with the same dimensions as the receiving space 27 of the dispensing device 1 or the pressure generator 5. Preferably, the receiving space of the test system is also made of the same material as the receiving space 27 of the dispensing device 1.

[0220] 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 like the contact element 26.

[0221] Furthermore, it is preferred that the testing system has a ram 29 or a central element 30. The ram 29 or the central element 30 preferably simulates the conveying element 9. It is preferred that the ram 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 the axis A as the conveying element 9. The ram 29 and the central element 30 will be described in more detail later.

[0222] Preferably, components of the dispensing device 1 or the pressure generator 5 that are not relevant for sealing the receiving space 27, for example the discharge nozzle 12 or all parts that are not part of the pressure generator 5, are omitted in the test system, or the test system does not have such components.

[0223] In this sense, the receiving space 27 or the pressure generator 5 or the dispensing device 1 is preferably only simulated in the test system.

[0224] In the batch method or the 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. The mean value is then preferably 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.

[0225] The assembly parameter M is preferably selected or adjusted such that for different batches of sealing elements 24 - at least substantially - 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. In other words, the assembly parameter M is preferably selected such that each time a dispensing device 1 is assembled, the same deformation value or filling level of the sealing element 24 results in the receiving space 27. The seal or sealing effect is significantly determined by the deformation value or filling level, so that reliable sealing can be achieved even when there are differences between the sealing elements 24 of different batches.

[0226] An "equal" or "at least substantially equal" deformation value or degree of filling preferably refers to degrees of filling or deformation values ​​that differ only slightly from one another and / or are identical within a tolerance. In this respect, it is possible that identical deformation values ​​or degrees of filling do not exactly match or differ slightly from one another. Two deformation values ​​or degrees of filling are considered equal in particular if they differ from one another by less than 10%, preferably less than 5%, in particular less than 2%, most preferably less than 1%.

[0227] The assembly parameter M is preferably an adjustable, in particular geometric, value that must be observed during assembly of the dispensing device 1 and / or is realized in the fully assembled dispensing device 1. The assembly parameter M can preferably be specified variably in the settings of an assembly process. 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. The assembly parameter M is preferably 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 contact element 26, as explained above, preferably correlates to the volume of the receiving space 27 and thus preferably also to a deformation of the sealing element 24, the (batchwise) use or specification of the assembly parameter M can easily ensure that a reliable sealing of the conveying element 9 by the sealing element 24 is achieved with different batches of sealing elements 24.

[0228] It is also possible that the assembly parameter M corresponds only indirectly to a position of the fixing element 25 or contact element 26, for example in that the assembly parameter M is defined or formed by a feed path which is traversed by a part of a device for assembling the dispensing device 1 or for fastening the fixing element 25 to the guide element 23 or the like.

[0229] According to a further example, in which the assembly parameter M corresponds in particular only indirectly to a position of the fixing element 25 or contact 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 union nut, as explained above by way of example. By specifying a rotation angle or screw drive, in particular the end position of the component or the nut and thus indirectly its axial position or the height of the receiving space 27 can be determined.

[0230] 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 heights H of the receiving space 27. In other words, each assembly parameter M or each value of the assembly parameter M preferably corresponds to a specific volume of the receiving space 27 or a specific height H of the receiving space 27.

[0231] 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 height H of the receiving space 27 is 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 a height H 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 a specific height H of the receiving space 27.

[0232] The volume or height H of the receiving space 27 can preferably be adjusted or fixed using 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 space 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 seal is achieved for different sealing elements 24 or batches of sealing elements 24.

[0233] Preferably, the assembly parameter M for a batch is initially determined based on a subset or sample of sealing elements 24 of the batch. Subsequently, the determined or selected assembly parameter M is preferably used for each assembly of a dispensing device 1 or each fixation of a sealing element 24 of the respective batch in a receiving space 27. In particular, the assembly parameter M is a value that can be (simply) set during assembly of the dispensing device 1 and / or does not need to be measured or determined, thus enabling fast and efficient, in particular automated, assembly of a plurality of dispensing devices 1.

[0234] 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.

[0235] 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. In particular, several hundred or several thousand dispensing devices 1 are assembled per hour.

[0236] For assembly, a sealing element 24 is first inserted into a receiving space 27 of a dispensing device 1. Subsequently, a fixing element 25 and / or abutment element 26 is inserted into the receiving space 27. As already described above, the fixing element 25 and the abutment 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 illustrated in the figures, the fixing element 25 and the abutment element 26 are formed by two separate components. In this case, the abutment element 26 is inserted into the receiving space 27.

[0237] The fixing element 25 or contact 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 predetermined assembly parameter M is used, which preferably determines how far the fixing element 25 or contact element 26 is moved into the receiving element 27 or in which position the fixing element 25 and / or contact element 26, in particular the contact element 26, is to be fixed by means of the fixing element 25.

[0238] Preferably, the contact element 26 is moved into the desired position by means of a punch or ram. The punch or ram can, for example, be basically similar to the ram 29 described in more detail below, which is used in determining the assembly parameter M and in the Fig. 4A-Dis shown. Preferably, however, the punch or tappet used during assembly does not have a central element 30 and / or the punch or tappet does not penetrate the contact element 26 and / or the sealing element 24 during assembly.

[0239] The fixing element 25 is preferably pushed over the contact element 26 and / or the guide element 23 after the contact element 26 has been positioned in the position corresponding to the assembly parameter M or defined by the assembly parameter M.

[0240] However, it is also possible that the fixing element 25 is already pushed over the contact element 26 when the contact element 26 is positioned and / or contacts the contact element 26, so that the fixing element 25 and the contact element 26 are moved simultaneously in the direction of the sealing element 24. In this case, the contact element 26 is moved indirectly via the fixing element 25 in the direction of the sealing element 24. In this case, the punch or plunger for moving the fixing element 25 and contact element 26 preferably contacts the fixing element 25 and acts only indirectly on the contact element 26 via the fixing element 25.

[0241] When the fixing element 25 and / or support element 26 have reached the desired position or the position defined by the assembly parameter M or corresponding to the assembly parameter M, the fixing element 25 is preferably fastened or fixed to the guide element 23.

[0242] It is preferred that the fixing element 25 is additionally fixed or fastened to the contact element 26.

[0243] The term "fixing" a sealing element 24 is understood, in particular, to mean the fixing or clamping of the sealing element 24 in the receiving space 27 in such a way that the sealing element 24 cannot move and / or be demolded in the receiving space 27, in particular, that it cannot return to its undeformed initial shape. This is preferably achieved by fixing 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 against the sealing element 24 and thus deforms it, so that the sealing element 24 bears against the boundaries of the receiving space 27, in particular against the guide element 23 and / or the fixing element 25 or contact element 26, over a large area or as far as possible on all sides.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.

[0244] The sealing element 24 is preferably fixed by fixing the mounting element 26 and / or by attaching the fixing element 25 to the guide element 23 and / or mounting element 26. Preferably, the height H and / or the volume of the receiving space 27 is defined, determined, or fixed by attaching the fixing element 25 to the guide element 23.

[0245] After securing the fixing element 25 and / or the contact element 26, the conveying element 9 is preferably mounted. For this purpose, the conveying element 9 is inserted into the channel 23b through the fixing element 25, the contact element 26 and / or the sealing element 24. In principle, however, the assembly or insertion of the conveying element 9 can also take place before securing the fixing element 25 and / or the contact element 26.

[0246] Preferably, during the assembly of the dispensing device, the relative position of the fixing element 25 and / or the support element 26 with respect to the guide element 23 can be predetermined or adjusted by means of the assembly parameter M. Preferably, a displacement or height measurement is performed during assembly, by means of which the height H of the receiving space 27 and / or the relative position of the fixing element 25 or support element 26, in particular relative to the receiving space 27 or its base 27a and / or the guide element 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.

[0247] In particular, by determining the assembly parameter M or its value in batches, it is not necessary to redetermine or adjust the assembly parameter M or its value each time a dispensing device 1 is assembled. Instead, the assembly parameter M or its value is preferably first determined for a batch (based on a subset or sample of sealing elements 24 of the batch) and then used for each sealing element 24 of that batch. This simplifies and accelerates the process for assembling dispensing devices 1.

[0248] The determination of the assembly parameter M will now be explained in more detail, particularly with reference to the Figures 4A to 4D and 5 .

[0249] 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.

[0250] This is in the Figures 4A-D shown. In Fig. 4A The figure shows that the system element 26 has already been inserted into the receiving chamber 27, but is not yet in contact with the sealing element 24. Fig. 4B The system element 26 was moved so far into the receiving space 27 that it is in contact with the sealing element 24.

[0251] The Fig. 4C shows the same situation as Fig. 4A . The Fig. 4D shows the same situation as Fig. 4B . The Figures 4C and 4D differ from the Figures 4A and 4B merely by the fact that the sealing element 24 is in the Figures 4C and 4Dhas a smaller volume, a smaller diameter, or a smaller cord thickness D than the sealing element 24 in the Figures 4A and 4B .

[0252] Subsequently, the sealing element 24 is preferably deformed in the receiving space 27, in particular by means of the fixing element 25 and / or contact element 26, or pressed into the receiving space 27. This is done in particular by exerting a force or pressure on the sealing element 24, in particular by means of the fixing element 25 and / or contact element 26. A deformation of the sealing element 24 by the contact element 26 for determining the assembly parameter M during or during the determination of the assembly parameter M is particularly in Figure 4D shown.

[0253] 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.

[0254] Preferably, the force or pressure is exerted on the sealing element 24 or the sealing element 24 is deformed by means of a plunger 29. In particular, the fixing element 25 or contact element 26 is moved in the direction of the sealing element 24 or into the receiving space 27 by means of the plunger 29, so that the fixing element 25 or contact element 26 contacts the sealing element 24 and deforms it by exerting a force or pressure on the sealing element 24. The plunger 29 is shown, for example, in Fig. 4A-D shown.

[0255] Preferably, the plunger 29 acts only indirectly on the sealing element 24. It is preferably provided that the plunger 29 acts or presses, in particular axially, on the fixing element 25 and / or contact element 26. In particular, the plunger 29 is moved axially relative to 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.

[0256] The plunger 29 is preferably not part of the dispensing device 1, but part of a testing system in which the determination of the assembly parameter M is carried out.

[0257] For or during the determination of 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, for example, in Fig. 4A-D shown.

[0258] In particular, the central element 30 represents an inner radial boundary of the receiving space 27 during the correlation measurement or determination of the assembly parameter M.

[0259] The central element 30 preferably has the same diameter or the same external dimensions in the radial direction as the conveying element 9.

[0260] Preferably, the central element 30 is a portion 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 form a separate component.

[0261] The central element 30 can be tapered, conical, and / or rounded at least in one section, so that upon axial advancement of the central element 30, the radial extent or width B of the receiving space 27 delimited 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.

[0262] In principle, the central element 30 can also be formed by the conveying element 9.

[0263] 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.

[0264] 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.

[0265] 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.

[0266] The deformation value "exceeding" the threshold value is understood to mean both when the deformation value is initially smaller than the threshold value and subsequently reaches a value that is larger 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 that is smaller than the threshold value.

[0267] 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.

[0268] 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 a measure that indicates how strongly and / or in what manner the sealing element 24 is deformed and / or compressed. The deformation value is preferably determined indirectly based on a characteristic value, as will be explained in more detail below.

[0269] In the Figures 5B and 5C The deformation of the sealing element 24 is shown schematically.

[0270] Fig. 5B The undeformed sealing element 24 is shown, particularly before being inserted into the receiving chamber 27. In the illustration example according to Fig. 5B The sealing element 24 has a circular cross-section with a diameter or a cord thickness D. In principle, however, the sealing element 24 or its cross-section can have any shape.

[0271] In Fig. 5Ca deformed sealing element 24 is shown. In particular, the illustration in Figure 5C a sealing element 24 inserted and fixed in a fully assembled dispensing device 1 or its receiving space 27. As can be seen from Fig. 5C As can be seen, the sealing element 24 was compared to the initial situation in Fig. 5B deformed and is adapted, in particular in its external shape, to the shape of the receiving space 27.

[0272] 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 external shape of the sealing element 24 is changed or adapted to the receiving space 27. Typically, with a further increase in the pressure or force applied or deformation of the sealing element 24, a volume compression, i.e., a change or reduction in the volume, of the sealing element 24 occurs following the pure shape change, in particular in addition to the primary pure shape change.

[0273] Particularly 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 or starts. Depending on the material of the sealing element 24, however, it may also be desirable or advantageous to select a value as the threshold value that is specifically above or below the value at which the 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 volume compression does not yet begin.

[0274] 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.

[0275] The investigation or determination of the deformation behavior and / or friction behavior is subsequently carried out using the following: Fig. 4A-D and 5 explained in more detail.

[0276] 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.

[0277] To investigate or determine the friction behavior, a boundary of the receiving space 27, in particular the central element 30, and the sealing element 24 are preferably moved relative to one another and the friction force between the sealing element 24 and the boundary is determined at several points in time during the deformation.

[0278] 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 need 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.

[0279] To investigate the deformation and / or friction behavior, a characteristic value is preferably measured. The characteristic value can be used, in particular, to draw conclusions about the deformation value or to determine the deformation value. 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. Thus, preferably, each value of the characteristic value corresponds to a specific deformation value.

[0280] 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.

[0281] The force is preferably related to a specific area, in particular the area of ​​the receiving space 27 or the base 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."

[0282] The deformation behavior is preferably determined by the force or pressure exerted on the sealing element 24 for deformation. Alternatively or additionally, the deformation behavior is determined (indirectly) by a position, in particular an axial one, of the plunger 29 and / or the fixing or contact element 25, 26.

[0283] The position of the plunger 29 and / or fixing or contact element 25, 26 determines in particular a height H of the receiving space 27.

[0284] In particular, the height H of the receiving space 27 or a value correlated therewith, such as a feed or axial position of the plunger 29 and / or the fixing or contact element 25, 26, can be specified or adjusted, and the corresponding force can be determined or measured. In a reversal of this principle, however, it is also possible to specify or adjust the force and determine or measure the height H of the receiving space 27 corresponding to the respectively set or specified force, or the value correlated therewith.

[0285] The force or pressure and / or position of the plunger 29 are preferably measured. However, it is also possible for the force, pressure, and / or position to be known, predetermined, or calculable or determinable without an 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.

[0286] Alternatively or additionally to determining the deformation behavior of the sealing element 24 during deformation, the friction behavior can also be determined while the sealing element 24 is being deformed, as already mentioned. The deformation of the sealing element 24 in the receiving space 27 can also be determined (indirectly) by measuring an auxiliary parameter such as 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. As the contact pressure of the sealing element 24 on the boundary increases, the frictional force also increases. The increase in the frictional force 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, with increasing deformation of the sealing element 24, the contact pressure increases, resulting in a changed, in particular increased, frictional force between the sealing element 24 and the boundary of the receiving space 27. Initially, there is 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 or gradient of the frictional force is greater during compression of the sealing element 24 than during elastic deformation of the sealing element. The friction behavior thus makes it possible to draw conclusions about the deformation or deformation behavior of the sealing element 24, in particular to determine the deformation or deformation behavior of the sealing element 24 (indirectly or indirectly).

[0287] 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) auxiliary measurement quantity, preferably represents the characteristic value from which the deformation value and thus in particular also the threshold value is determined, calculated or derived.

[0288] In this method, it is preferably provided that the fixing element 25 or attachment element 26 is connected by means of a further element in the Fig. 4A-D fixed by the plunger (not shown) or moved or pressed into the receiving space 27.

[0289] In principle, however, the frictional force can also be measured in another way, for example by rotating the plunger 29 or the central element 30 relative to the sealing element 24 and / or about the axis A and measuring the torsional friction or torsional friction force occurring in the process.

[0290] 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.

[0291] 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 medicament sprayed as aerosol 14 using the dispensing device 1.

[0292] In particular, a force-displacement curve is recorded to investigate or determine the deformation behavior or friction behavior and / or to determine the assembly parameter M. Most preferably, the assembly parameter M is determined based on the shape of the force-displacement curve.

[0293] In Fig. 5A An example of a force-displacement curve is shown. A displacement is plotted on the x-axis and a force F is plotted on the y-axis.

[0294] In Figure 5AThe path is represented by the height H of the receiving space 27. However, the path can also correspond to the traveled path or the position of the plunger 29 and / or the fixing or contact element 25, 26, with which the sealing element 24 is deformed. The path can be measured or known in some other way, for example from a control parameter, such as an electrical voltage or the like, by which a feed of the plunger 29 and / or the fixing or contact element 25, 26 is controlled or regulated. In particular, a specific value of the path or height H corresponds to a specific volume of the receiving space 27.

[0295] The force F is, for example, the force already explained that is exerted on the sealing element 24 to deform it, or a corresponding quantity such as the pressure exerted 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.

[0296] A specific deformation or a specific deformation value of the sealing element 24 preferably corresponds to a specific force required to achieve this deformation or this deformation value, and / or to a specific height H of the receiving space 27 or a value correlated therewith at which this deformation or this deformation value is achieved. In particular, the deformation value can therefore be determined using the force and / or the height H.

[0297] Examples include Fig. 5ATwo different forces F1, F2 and the corresponding paths or heights H1, H2 are shown. The path or height H is preferably correlated with the traveled path or the position of the plunger 29, with which the sealing element 24 is deformed.

[0298] The Fig. 5A is explained below "from right to left", i.e. starting with large values ​​of H. The force-displacement curve starts 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, particularly preferably the cord thickness of a toroidal sealing element 24, as for example in Fig. 5B At this point, the fixing element 25 or contact element 26 contacts the still undeformed sealing element 24, as shown for example in Fig. 4BAt this point, the force F has the value zero, since no deformation has yet occurred or no force is exerted on the sealing element 24.

[0299] For the deformation or (elastic) deformation of the sealing element 24, preferably only a small force is initially required. With increasing deformation, the force initially increases 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 advance of the plunger 29 in the direction of the sealing element 24 and / or receiving space 27, the volume of the receiving space 27 is reduced and, accordingly, the sealing element 24 is pressed further or more firmly into the receiving space 27 and is deformed in the process.

[0300] Due to the elasticity of the sealing element 24, the force required for the pure change in shape or deformation is relatively low.

[0301] As the height H decreases, the volume of the receiving space 27 decreases and thus the degree of filling, i.e. the ratio between the volume of the sealing element 24 and the receiving space 27.

[0302] The force F increases with decreasing height H or decreasing volume of the receiving space 27.

[0303] In particular, as the height H continues to decrease, compression of the sealing element 24 begins, as already explained. When compression begins, the gradient of the force-displacement curve increases, since a greater force is required to compress the sealing element 24 than to simply change its shape.

[0304] The deformation, in particular the onset of compression, can therefore be read or determined in particular from the force-displacement curve or its course, in particular its gradient and / or curvature.

[0305] In particular, the gradient and / or curvature of the force-displacement curve changes when the volume compression of the sealing element 24 begins. This occurs in the example shown in Fig. 5A in particular approximately between the positions H1 and H2 or values ​​F1 and F2 shown there. If the height H is reduced even further, a volume compression essentially or predominantly occurs. This requires a high force, so that in the left area in Fig. 5A high forces F are reached or the force-displacement curve has a high gradient or rises steeply (towards smaller values ​​of H).

[0306] 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.

[0307] To determine the assembly parameter M, it is preferably determined or ascertained on the basis of the force-displacement curve 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 to the onset of the volume compression.

[0308] In other words, the specific characteristic value K is in particular that value of the characteristic value at which the volume compression of the sealing element 24 begins.

[0309] As explained above, volume compression begins particularly at the point where the force-displacement curve exhibits its greatest curvature and / or a kink. The specific characteristic value K therefore preferably corresponds to the force at which the force-displacement curve exhibits its (at least substantially) greatest curvature and / or a kink, and correlates in the illustrative example according to Fig. 5A with a height HM desired or preferred during assembly, which in turn correlates to the desired assembly parameter M.

[0310] For different sealing elements 24 or batches of sealing elements 24, different courses of the force-displacement curve and thus different specific characteristic values ​​K or height HM or assembly parameters M can result.

[0311] The assembly parameter M is preferably selected or determined such that it corresponds to an onset of volume compression of the sealing element 24. In accordance with the above explanations, the assembly parameter M is therefore preferably selected such that the height of the receiving space 27 in the fully assembled dispensing device 1 at least substantially corresponds to the height HM at which the force-displacement curve exhibits the greatest curvature and / or a kink. In particular, the assembly parameter M corresponds to the height HM of the receiving space 27 at which the volume of the (deformed) sealing element 24 corresponds to the volume of the receiving space 27 or a fill level of at least substantially 100% is achieved.

[0312] However, the assembly parameter M can also be selected or determined such that it corresponds to a different deformation or deformation value of the sealing element 24, for example, 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.

[0313] The assembly parameter M can therefore also correspond to other filling levels or correspond to a filling level other than 100%, for example, a (random) filling 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 better sealing and / or service life than a filling level of 100%.

[0314] Preferably, for each batch, a sample is used to determine under which conditions or at which specific characteristic value K, in particular at which force in the force-displacement curve, the deformation value reaches or exceeds a desired threshold value. The assembly parameter M is then selected such that when a sealing element 24 of the batch is assembled, the deformation value reaches or exceeds the threshold value. The assembly parameter M therefore corresponds in particular to the corresponding height HM or the specific characteristic value K. The assembly parameter M is preferably selected such that at or by the position in which the fixing element 25 is fastened to the guide element 23 orthe contact element 26 is fixed in a position, the same volume of the receiving space 27 is realized as is the case when, when determining 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 assumes the threshold value. In other words, the assembly parameter M is preferably selected such that the height (and thus in particular the volume) of the receiving space 27 of the fully assembled dispensing device 1 has the same value as the travel or height HM in the force-travel curve, which corresponds to the specific characteristic value K.

[0315] To determine or when determining the assembly parameter M, the deformation value to which the selected or determined assembly parameter M corresponds is preferably exceeded. For example, the Fig. 5AThe value F2 shown is the maximum force exerted on the sealing element 24 when determining the assembly parameter M and which is in Fig. 5A The assembly parameters M shown are the selected or specific assembly parameters M.

[0316] To determine the assembly parameter M, the force-displacement curve is preferably traversed beyond a height H to which the assembly parameter M corresponds. This is particularly due to the fact that the greatest curvature or gradient can only be reliably determined once the point of greatest curvature or gradient has already been exceeded.

[0317] In the batch process explained so far, as described above, the assembly parameter M for a batch of sealing elements 24 is first determined in a separate process, in particular based on a sample, and then used in the assembly of the sealing elements 24 of the batch.

[0318] However, the separation of the steps of determining the assembly parameter M and the actual assembly of a dispensing device 1 is not mandatory.

[0319] 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.

[0320] The individual method is particularly advantageous when, during an assembly of dispensing devices 1, in particular an automatic or serial assembly, work is to be carried out without 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 variables 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 cannot be ensured by determining a single assembly parameter M for all sealing elements 24 of the batch.

[0321] Nevertheless, the individual method described in more detail below is also generally applicable if the sealing elements 24 are present in batches and the sealing elements 24 of a batch differ so little from one another that the batch method would also be generally applicable.

[0322] The determination of the assembly parameter M in the individual process is preferably - at least essentially - carried out as described above for the batch process in connection with Fig. 4A-E and 5 described, in particular by determining the deformation behavior and / or friction behavior of the sealing element 24 during a deformation in the receiving space 27 or by the course of a force-displacement curve.

[0323] The above statements regarding the determination of the assembly parameter M therefore preferably also apply to the individual method.

[0324] In contrast to the one in Fig. 4A-D The plunger 29 shown, which is used in the batch process, preferably does not have a central element 30 in the individual process, or the plunger 29 is not passed through the mounting element 26 and / or the sealing element 24.

[0325] Preferably, however, instead of the central element 30, the conveying element 9 is 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.

[0326] As described in the batch process, the sealing element 24 is also deformed in the individual process for determining the assembly parameter M, whereby the desired deformation of the sealing element 24 or the desired deformation value of the sealing element 24 is exceeded when determining the assembly parameter M.

[0327] Accordingly, after the determination of the assembly parameter M has taken place or been completed, the plunger and thus the fixing element 25 or contact element 26 are preferably moved back a little, i.e. in particular in the direction of the fixing element 25 or contact element 26 facing away from the sealing element 24. In particular, the fixing element 25 or contact element 26 is thereby positioned such that the assembly parameter M is realized or the position of the fixing element 25 and / or contact element 26 corresponds to the determined assembly parameter M. This ensures that the sealing element 24 assumes the desired deformation value or the desired deformation value is realized.

[0328] In this position, the fixing element 25 or contact element 26 or sealing element 24 is then preferably fixed, in particular by fixing or fastening 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 fastened as described above, for example by crimping.

[0329] 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.

[0330] 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.

[0331] 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 an agent having properties for curing, alleviating or preventing human or animal diseases or pathological conditions, or which can be applied to the human or animal body or administered to a human or animal either to restore, correct or influence physiological functions through a pharmacological, immunological or metabolic action or to make a medical diagnosis.

[0332] 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 corresponds only indirectly to a position of the fixing element or contact element, for example in that the assembly parameter is defined or formed by a feed path that is traversed by a part of a device for assembling the dispensing device or for fastening the fixing element to the guide element, or the like.

[0333] 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.

[0334] 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 predefinable. 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. However, depending on the material of the sealing element, 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.

[0335] 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 from the characteristic value. The characteristic value can, for example, be a force (in particular a compressive force or a frictional force), a pressure, or a position, in particular a measured force. In particular, the characteristic value is therefore a measured value from which conclusions can be drawn about the deformation value.

[0336] A "compression set" within the meaning of the present invention is preferably a material property of a material from which a sealing element is made. In particular, the compression set is a measure of how the material, in particular an elastomer, behaves under prolonged and / or constant compression deformation and preferably subsequent relaxation. The compression set is preferably determined according to DIN ISO 815-1:2016-09. To determine the compression set, a cylindrical test specimen is preferably compressed, in particular by 25%, and stored at a specific temperature for a specific period of time. After the load is removed, preferably 30 minutes after the load is removed, the permanent deformation of the test specimen is determined by comparing the height of the test specimen before compression and the height of the test specimen after unloading.In particular, 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.

[0337] The "creep behavior" or "creep" of a material or sealing element within the meaning of the present invention is specifically the behavior of the material or sealing element under constant load. In particular, the creep behavior or creep is a time- and / or temperature-dependent plastic deformation under a constant load. The creep behavior or creep is determined or characterized in particular by the creep modulus.

[0338] A "fixing" 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 or cannot deform further in the receiving space.

[0339] The aspects and features explained above can be implemented independently of one another, but also in various combinations. In particular, the batch process and the individual process can be combined. In other words, steps explained in connection with the batch process can also represent steps of the individual process, and vice versa. List of reference symbols:

[0340] 1 Dispensing device 26b stop 2 drug 26c Introductory section 3 container 27 recording room 4 Fluid space 27a Floor 5 Pressure generator 28 feed channel 6 bracket 29 pestle 7 Drive spring 30 Central element 8 Locking element 31 Positioning device 8a shutter button 31a Helix structure 9 Conveying element 31b locking elements 10 Check valve 11 pressure chamber A axis 12 Discharge nozzle B Width 13 mouthpiece D Cord thickness 14 aerosol F Power 15 Supply air opening K specific characteristic value 16 (upper) housing part H Height 17 inner part HM Height for mounting 17a upper part (inner part) M Assembly parameters 17b lower part (inner part) 18 (lower) housing part 19 Holding element 20 Feather 21 Container bottom 22 piercing element 23 Guide element 23a Fastening section 23b channel 23c recess 24 Sealing element 24a opening 25 Fixing element 25a Opposite surface 26 Investment element 26a Contact section 26a

Claims

1. A method for assembling dispensing devices (1) for dispensing a medicament (2), wherein the dispensing devices (1) which are to be assembled each comprise a conveying element (9) which can be moved in particular axially for conveying the medicament (2), a guide element (23) for guiding the conveying element (9), and a preferably ring-shaped sealing element (24) 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), wherein according to the method, a preferably ring-shaped sealing element (24) is arranged in a receiving space (27) of the dispensing device (1) or in a receiving space (27) in a test system, wherein the receiving space in the test system has the same dimensions as the receiving space of the dispensing device, characterized in that the sealing element (24) arranged in the receiving space (27) is deformed, and an assembling process parameter (M) is determined in the process on the basis of the deformation behavior and / or friction behavior of the sealing element (24) during the deformation, wherein the sealing element (24), or a different sealing element (24) to be installed, is fixed in a receiving space (27) of a dispensing device (1) using the assembling process parameter (M).

2. The method according to claim 1, characterized in that a plurality of sealing elements (24) is provided in batches, and an assembling process parameter (M) is determined separately for each batch using a random sample of sealing elements (24) of the given batch, wherein the assembling process parameter (M) determined for this batch is used for each fixing of a sealing element (24) of the batch in a receiving space (27).

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

4. The method according to claim 2 or 3, characterized in that, to determine the assembling process parameter (M) of a batch, an assembling process parameter (M) is first determined separately for each sealing element (24) in the random sample, and a mean value of these assembling process parameters (M) determined separately is defined as the assembling process parameter (M) for all sealing elements (24) of this batch.

5. The method according to any of claims 2 to 4, characterized in that, to determine the assembling process parameter (M), a central element (30) is guided through an opening (24a) in the sealing element (24) and / or through the receiving space (27), and the volume of the receiving space (27) is reduced or delimited by the central element (30).

6. The method according to any of claims 2 to 5, characterized in that the number of sealing elements (24) in the random sample is less than 50‰, preferably less than 20‰, in particular less than 10‰, particularly preferably less than 5‰, very particularly preferably less than 2‰ of the number of sealing elements (24) of the batch, and / or in 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. The method according to claim 1, characterized in that immediately after the deformation and determination of the assembling process parameter (M), the sealing element (24) is finally fixed in the receiving space (27) by means of a fixing element (25) or contact element (26) acting on the sealing element (24).

8. The method according to claim 1 or 7, characterized in that the assembling process parameter (M) is determined separately for each sealing element (24) to be installed and is used in each case only when fixing the sealing element (24) for which it was determined.

9. The method according to any of the preceding claims, wherein the assembling process parameter (M) is a particularly adjustable and / or geometric value which is prespecified for and / or implemented in the assembly of the dispensing device (1), preferably wherein the assembling process parameter (M) can be prespecified in a preferably variable manner in the configurations of an assembling process.

10. The method according to any of the preceding claims, characterized in that the assembling process parameter (M) is a position, in particular an axial position, of a fixing element (25) or contact element (26) relative to the receiving space (27) and / or to a guide element (23) of the dispensing device (1), or that a position, in particular an axial position, of a fixing element (25) or contact element (26) relative to the receiving space (27) and / or to a guide element (23) of the dispensing device (1) is defined by the assembling process parameter (M), in particular wherein the guide element (23) at least partially delimits the receiving space (27), and the fixing element (25) or contact element (26) is used for fixing the sealing element (24) in the receiving space (27).

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

12. The method according to any of the preceding claims, characterized in that the assembling process parameter (M) is selected or determined in such a manner that, when the sealing element (24) is fixed 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. The method according to any one of the preceding claims, characterized in that, to determine the deformation behavior and / or friction behavior of each of the sealing elements (24) with different deformations, in each case 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. The method according to claim 13, characterized in that the characteristic value is a force, in particular a frictional force or a compressive force, a pressure, or a position.

15. The method according to any of the preceding claims, characterized in that, to determine the deformation behavior of each of the sealing elements (24), the force required for deformation is determined in each case for different deformations.

16. The method according to any of the preceding claims, characterized in that, to determine the friction behavior of each of the sealing elements (24), the sealing element (24) and a boundary of the receiving space (27) are moved relative to one another, and the frictional force between the sealing element (24) and the boundary is determined in each case for different deformations.

17. The method according to any 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 assembling process parameter (M), preferably wherein the assembling process parameter (M) is determined on the basis of the profile and / or the curvature of the force / displacement curve.

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

19. A dispensing device (1) for dispensing a medicament (2), having a conveying element (9) which can be moved in particular axially for conveying the medicament (2), a guide element (23) for guiding the conveying element (9), and a particularly ring-shaped sealing element (24) 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) which can be fastened to the guide element (23), characterized in that the fixing and / or contact element (25, 26) can be fastened to the guide element (23) in different discrete positions, and the sealing element (24) can thereby be fixed with a previously determined assembling process parameter (M), wherein the fixing and / or contact element (25, 26) can be locked on the guide element (23) in the different discrete positions and wherein the different discrete positions are axially different positions of the fixing and / or contact element (25, 26) relative to the guide element (23).

20. The dispensing device according to claim 19, characterized in that the fixing and / or contact element (25, 26) and / or the guide element (23) has / have a positioning device (31) for positioning the fixing and / or contact element (25, 26) relative to the guide element (23), wherein the positioning device (31) has or is formed by one or more locking elements (31b).

21. The dispensing device according to claim 20, characterized in that the positioning device (31) has or is formed by an inclined plane or helix structure (31a).

22. The dispensing device according to any of claims 19 to 21, characterized in that the rotational position of the fixing and / or contact element (25, 26), in particular relative to the guide element (23) or the dispensing device (1), defines the axial position of the fixing and / or contact element (25, 26).

23. The dispensing device according to any of claims 19 to 22, characterized in that the position of the fixing and / or contact element (25, 26) defines a deformation of the sealing element (24) and / or a size of the receiving space (27), 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 contact element (26).