Nozzle holder for inhalation device

Abstract

The present invention relates to the field of inhalation devices for liquids. In particular, the present invention relates to a holder for a spray nozzle used in such an inhalation device. A nozzle fixing assembly (1) for an inhalation device, comprising an elastically deformable sealing element (2), the sealing element having a continuous opening (3) capable of accommodating a nozzle body (4), the sealing element (2) and the nozzle body (4) respectively having a high-pressure side (2A, 4A) and an outlet side (2B, 4B); and a pressure element (5) having a high-pressure side (5A), the side being arranged to face the high-pressure side (2A) of the sealing element (2); wherein (i) the high-pressure side (2A) of the sealing element (2) is substantially flat, and (ii) in the assembled state, the high-pressure side (5A) of the pressure element (5) is chamfered in such a way that the distance between these high-pressure sides (2A, 5A) is higher in a central area (C) than in a peripheral area (P).

Description

Technical Field

[0001] The present invention relates to the field of inhalation devices for liquids. In particular, the present invention relates to a holder for a spray nozzle used in such an inhalation device. Background Art

[0002] In the art, aerosols or other aerosol generators for liquids have been used for a long time. Among other things, this type of device has also been used in medical science and treatment. Here, they are used as suction devices to apply active ingredient in aerosol (that is, the droplets embedded in the gas) form. For example, known this suction device from document EP 0627230B1. The essential parts of this suction device are a container for liquid to be atomized, a pumping unit for generating a sufficiently high pressure for atomization, and a spray device in the form of a nozzle.

[0003] An improvement of such an inhalation device is disclosed in patent application EP 17168869 filed by the same applicant as the present invention, the entire content of which is incorporated herein by reference.

[0004] In order to obtain a sufficiently uniform and fine droplet mist, a relatively high pressure is usually required, such as 10 bar, up to 1000 bar. In order to keep the amount of evaporated liquid for each dose at an acceptably low level, the spray nozzle usually comprises one or several channels, each channel having a diameter of only a few μm. 2 Step (e.g., from 2 μm 2 to 200μm 2 ) cross section. Passage is present in the nozzle body, and is usually manufactured using micro-process manufacturing techniques such as micro-etching, micro-photolithography, etc. However, these technologies are usually targeted at hard and brittle materials (such as silicon, glass or metal), and in order to avoid any undesirable deformation of the nozzle body when bearing the high pressure, the nozzle body is usually made of very rigid material. However, this vulnerable and indispensable element of the whole device must be firmly fixed in the whole device. This relates to liquid tightness and mechanical safety. Therefore, the fixing of the nozzle body in the suction device needs special attention.

[0005] EP 0 853 498 B1 discloses a nozzle holder comprising a pot-shaped holder having a recessed interior and a resilient molded part configured to fit into the recessed interior. The molded part itself has an opening designed to receive the nozzle body. When inserted into the recessed interior, one of the surfaces of the molded part (and the nozzle body) is exposed to high pressure during use. The bottom of the holder has a small hole aligned with the nozzle outlet, and the mating walls of both the holder and the molded part are frusto-conical in shape.

[0006] According to the latest document DE 10 2004 001 451 A1, filed by the same applicant as EP 0 853 498 B1, the aforementioned solution is suitable for both medium and high pressures, but provides insufficient sealing for low pressures, for example, less than 10 bar. Therefore, the latter document proposes a solution in which the retainer is supplemented on the high-pressure side with a counterpart that closes the retainer and has circumferential ridges designed to displace the elastic material of the molded part when it is pressed against the retainer during assembly. Furthermore, the molded part is not flat on its high-pressure side, but rather has an inclined recess in the center, resulting in a bevel or chamfer that is angled toward the centrally located nozzle body.

[0007] Although the latter solution is claimed to result in improved liquid tightness also at low pressure, the manufacture of the elastic molding becomes more complicated. Furthermore, since the high-pressure side and the low-pressure side are different from each other, the installation of the molding in the holder requires special attention.

[0008] The object of the present invention is to provide a device which avoids the disadvantages of the known art. In particular, the nozzle holder should provide adequate liquid tightness over the entire typical pressure range of an inhalation device and its components should be easy to manufacture and assemble. Summary of the Invention

[0009] The object is solved by a device according to claim 1. Advantageous embodiments are described in the respective dependent claims, in the subsequent description, and in the figures.

[0010] The nozzle holder assembly is for use in an inhalation device for generating an aerosol of a medically active liquid, and in particular an inhalable aerosol of such a liquid.

[0011] In a further aspect, the present invention relates to a medical inhaler or nebulizer for medical fluids, comprising a nozzle securing assembly as described herein and all its embodiments.

[0012] The nozzle retaining assembly, or simply the assembly, is adapted to be substantially pressure-tight, meaning that during normal use, no or very small, negligible leakage occurs despite the high pressures typically present upstream of the nozzle. The nozzle retaining assembly is particularly adapted to be pressure-tight when inserted into the nozzle body.

[0013] The assembly comprises an elastically deformable sealing element having a continuous opening capable of receiving a nozzle body, wherein the sealing element and the nozzle body respectively have a high-pressure side and an outlet side. In other words, the sealing element has an opening into which the nozzle body can be inserted. The opening is typically a through hole connecting the high-pressure side and the outlet side of the sealing element. Preferably, the cross-section of the opening is slightly larger than the cross-section of the nozzle body (e.g. 10 μm to 1 mm) so that the nozzle body can be easily inserted. The opening may have parallel walls, or it may have a slight wall angle that is narrower on the outlet side of the nozzle body. In one embodiment, the opening has a longitudinal axis that coincides with the longitudinal axis of the sealing element. In some embodiments, the nozzle fixing assembly comprises a nozzle body.

[0014] In one embodiment, the nozzle is of the type used in so-called soft mist inhalers and is configured to emit at least two jets of liquid to be atomized, such as an aerosol for colliding in air and forming dispersed droplets. Such a nozzle is suitable for functioning at relatively high pressures, such as in the range of about 10 bar to about 100 bar.

[0015] The nozzle body has a side (the high-pressure side) that is subjected to the high-pressure liquid when the device is actuated. The liquid is forced into one or more channels, which may optionally include a filter, etc. The opposite end of the channel(s) terminates at the actual nozzle outlet, where the inhalable mist is produced when the device is actuated. This end is surrounded by ambient pressure and is therefore referred to as the outlet or low-pressure side.

[0016] The sealing element is made of an elastically deformable material or includes a layer of elastically deformable material. Therefore, when subjected to high external pressure, the sealing element will deform and / or internal stresses will be built up, resulting in outward pressure. Typically, the external pressure can be the result of physical contact with another object or contact of a pressurized liquid with the surface of the sealing element. If the material of the sealing element is essentially incompressible, the volume remains constant. Pressurization of one surface will cause other surfaces to expand. If the material is compressible, the volume will decrease after pressurization, but the pressure will still be "transferred" throughout the material to the other surfaces, which will expand if the available space allows, or if suppressed, a certain counterpressure will be built up.

[0017] Furthermore, the assembly includes a pressure element having a high-pressure side, also referred to as a downstream side, disposed facing the high-pressure side of the sealing element. The pressure element is positioned opposite the high-pressure sides of both the sealing element and the nozzle body. The purpose of the pressure element is to apply pressure to the sealing element. This can be accomplished in various ways while achieving comparable results, as discussed in detail below.

[0018] Obviously, the pressure element must be configured to allow the liquid flowing into or diverted to the nozzle to be vaporized. This can be achieved, for example, by a central opening in the pressure element or by a plurality of openings that allow fluid communication between the liquid supply (e.g. from a container arranged further upstream) and the space between the pressure element and the sealing element (i.e. downstream of the pressure element).

[0019] Furthermore, the high-pressure side of the sealing element is substantially flat and lies in a plane perpendicular to the longitudinal axis of the sealing element.

[0020] According to the invention, the high-pressure side of the pressure element is chamfered in such a way that, in the assembled state, provided that the sealing element has not undergone any substantial deformation, the distance between the two high-pressure sides is greater in the central region than in the peripheral region. In other words, there is a central region (i.e., a region that is closer to the longitudinal axis) and a peripheral region (i.e., a region that is further away from the longitudinal axis and therefore closer to the end or edge of the side). "Chamfering" means that the distance between the surface of the high-pressure side and the high-pressure side of the sealing element decreases from the center of the surface towards the corner or circumference. In the context of the present invention, chamfering is used synonymously with skewing or tilting relative to the surface of the high-pressure element.

[0021] In a particular embodiment, the pressure element is chamfered in such a way that, in the assembled state, the distance between the high-pressure side of the sealing element and the pressure element is greater in a central region than in a peripheral region, wherein, when following the longitudinal axis, the central region corresponds to the region facing the continuous opening. In some embodiments, the central region is the region oriented toward the longitudinal axis of the sealing element.

[0022] In the sense of the present invention, a chamfer or a deflection or an inclination means that the thickness of the pressure element is greater than in a central region when the thickness is measured in the direction of the longitudinal axis.

[0023] Thus, in the assembled state, the chamfer can result in a void or void volume with a greater height in the central region than in the border or peripheral regions. This shape, in turn, results in a permanent or temporary application of pressure in the periphery of the high-pressure side of the sealing element. Consequently, the sealing element deforms and effectively seals against the nozzle body and, preferably, also against the solid surface on the other side.

[0024] According to one embodiment, the assembly further includes a holder (e.g., a can-shaped or cup-shaped) having a recess, within which a sealing element, a nozzle body, and a pressure element are arranged. In other words, the holder serves as a housing for the other elements. The holder includes a low-pressure surface that, in the assembled state, contacts the outlet side of the nozzle (i.e., the interior of the "front wall" forming the "front side") where the atomized liquid exits the assembly. The holder further includes an internal profile that matches the external profile of the elastic molded part, such that the gap between the profiles becomes smaller, thereby making it easier to perform a liquid seal. Furthermore, the holder has a high-pressure end that contains at least the high-pressure side of the pressure element. The recess in the holder is arranged in such a way that the sealing element (optionally, together with the nozzle housed in the opening in the sealing element) is inserted from the high-pressure side of the holder. Typically, the sealing element is fully inserted into the recess, and the pressure element can be partially or completely inserted into the holder. Its high-pressure side points to the inside of the holder and, thus, toward the high-pressure space.

[0025] This embodiment allows and advantageously facilitates the installation of the components into the device. Furthermore, testing and replacing the components are more easily accomplished.

[0026] In one embodiment, the recess has a truncated cone shape, which may also serve the purpose of easing assembly. Alternatively, the sealing element may have a corresponding truncated cone shape.

[0027] In one embodiment, in the assembled state, the high-pressure side of the pressure element is in at least partial physical contact with the high-pressure side of the sealing element. Mechanical pressure is applied to the high-pressure side of the sealing element, deforming the element and providing a permanent seal (as long as the physical contact is not lost). This solution provides excellent control over the amount of pressure applied to form the seal. Furthermore, even when the device is not actuated, residual liquid remains in the aforementioned space.

[0028] In one embodiment, in the assembled state, the distance is zero in the peripheral region (or at least a portion of the peripheral region) and greater than zero in the central region. In other words, the high-pressure side of the pressure element contacts the high-pressure side of the sealing element in the peripheral region rather than in the central region.

[0029] In another embodiment, in the assembled state, the high-pressure side of the pressure element is spaced apart from the high-pressure side of the sealing element so that no physical contact is established. In this embodiment, sealing is implemented by deformation of the sealing element, and the deformation is the result of the concentration of high-pressure pulses inside the above-mentioned space. Since the height of the space in the central area is greater than the height in the boundary area (periphery), the pressure pulses that occur when the actuating device form higher and higher pressures, thereby narrowing the space. Therefore, the pressure applied to the high-pressure side of the sealing element increases from the central area to the periphery. In other words, the pressure applied to the high-pressure side of the sealing element is uneven, but greater at the periphery. Therefore, the sealing element is pressed against the side wall of the nozzle body, thereby sealing it tightly. Further, a portion of the pressure is also distributed toward the front wall mentioned above, thereby also leading to sealing of the corresponding surface in order to block possible diversion to the nozzle channel.

[0030] In one embodiment, the chamfered surface has a rectilinear shape in a cross section along the longitudinal axis, which means that the angle between the longitudinal axis (or the surface of the high-pressure side of the sealing element) and a line extending from the center of the high-pressure side of the pressure element to its periphery is substantially constant.

[0031] In another embodiment, the line follows a concave curve, ie a curve having steep angles at the periphery and flat angles in the center.

[0032] In yet another embodiment, the wire follows a convex profile.

[0033] In one embodiment of the nozzle holding assembly, the high-pressure side of the pressure element is substantially completely chamfered. This means that from the center, or more precisely, from the edge of the high-pressure side serving as a possible opening for flow diversion to the pressure element, to the periphery, or more precisely, to the circumferential corners of the high-pressure side of the pressure element, the corresponding surfaces are inclined relative to the flat surface of the sealing element.

[0034] In another embodiment, the entire high-pressure side of the pressure element does not consist of a beveled or chamfered surface, but rather has a substantially flat central region, i.e., parallel to the high-pressure side of the sealing element. Consequently, the inner region of the side is substantially parallel to the aforementioned flat surface. However, the sealing effect still occurs due to the aforementioned effect of reducing the spatial height in the relevant, i.e., peripheral, regions.

[0035] In another embodiment, the pressure element acts as a closure for the high pressure end of the holder, thereby fulfilling the function of a closure or cap. Thus, no additional components are required to provide a compact assembly that is less susceptible to contamination than an open assembly.

[0036] In another embodiment, a separate cap is provided that can be attached to the high-pressure end. The cap pushes against the upstream side of the pressure element and holds it in the same position relative to the sealing element. Depending on the respective configuration, this can mean that the high-pressure side of the pressure element is spaced apart from the high-pressure side of the sealing element, or that it merely contacts or physically presses against the high-pressure side of the sealing element (see above).

[0037] According to another embodiment, the nozzle fixing assembly further comprises a gasket, which is arranged between the sealing element and the two high-pressure sides of the pressure element, and has one or more continuous openings for fluidically connecting the high-pressure space with the nozzle inlet. The opening(s) are arranged on the high-pressure side of the nozzle body so as to provide one or more corresponding split flows for the liquid.

[0038] Generally speaking, the purpose of the gasket is to serve as a means for further controlling the pressure exerted on the high pressure side of the sealing element.

[0039] The gasket has a first side for contacting the high-pressure side of the sealing element, the first side being substantially flat, and an opposite second side facing the high-pressure side of the pressure element. In other words, the gasket rests flatly on the sealing element, while the opposite side of the gasket is not flat and points toward the aforementioned space.

[0040] The second side of the gasket is chamfered in such a way that in the assembled state the distance between the second side and the high-pressure side of the sealing element is greater in the central region than in the peripheral region. Thus, a gap is provided between the second side of the gasket and the high-pressure side of the pressure element.

[0041] The void is narrower at its periphery than at its center.

[0042] In other words, the shape of the second side together with the relatively high pressure side of the pressure element reduces the above-mentioned space to some extent, but the remaining gap still allows the above-mentioned physical effect of pressure concentration.

[0043] At the same time, by adjusting the exact shape and size of the gasket, the specific effect on the effect can be precisely adjusted. This may be necessary when the device is adapted to atomize different liquids, which may have different fluid properties. Thus, to obtain the best sealing effect again, not the entire assembly, but only one of the components must be modified.

[0044] In another embodiment, in a cross-section along the longitudinal axis, the second surface of the gasket has a profile that is similar to the negative of the profile of the chamfered surface of the pressure element. This means that the profile of the second side of the gasket is the negative of the profile of the high-pressure side of the pressure element. This results in partially parallel surfaces; however, in the peripheral areas of the volume or void, there is still a reduction in the height of the void, meaning that in these areas, its height is shallower than in the more central areas.

[0045] In a particular embodiment, the present invention relates to a nozzle retaining assembly for an inhalation device, said assembly being adapted to maintain a substantially pressure-tight seal against a nozzle body when inserted into said nozzle body, said assembly comprising:

[0046] - an elastically deformable sealing element having

[0047] - longitudinal axis;

[0048] - a continuous opening along said axis capable of receiving said nozzle body;

[0049] - a high pressure side having a surface;

[0050] -Export side;

[0051] a pressure element having a surface on its high-pressure side, said high-pressure side being arranged facing the high-pressure side of the sealing element;

[0052] in

[0053] (i) the surface of the high pressure side of the sealing element is substantially flat and lies in a plane perpendicular to the longitudinal axis of the sealing element, and

[0054] (ii) The surface of the high-pressure side of the pressure element is chamfered or inclined in such a way that, in the assembled state, the distance between the surface of the high-pressure side of the sealing element and the surface of the high-pressure side of the pressure element is higher in a central area than in a peripheral area, wherein the central area is an area positioned toward the longitudinal axis of the sealing element and the peripheral area is an area positioned circumferentially with respect to the longitudinal axis of the sealing element.

[0055] Optionally, the nozzle mounting assembly further comprises a nozzle body. In other words, in this embodiment, the nozzle body is already part of the assembly and can be easily inserted into the aforementioned opening of the sealing element. Preferably, the outlet side of the nozzle body is aligned with the outlet side of the sealing element and / or aligned with the high-pressure side of the pressure element.

[0056] As explained, the present invention overcomes the shortcomings of the known technology. Especially, the nozzle holder assembly provides enough liquid tightness in the whole typical pressure range of the suction device, and its parts are easy to manufacture and assemble. In addition, in one embodiment, the assembly allows enhanced control of the sealing pressure. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] FIG1 shows a schematic cross-sectional view of a nozzle fixing assembly known in the art.

[0058] Figure 2 A schematic cross-sectional view of a nozzle fixation according to the invention is shown.

[0059] Figure 3 A schematic cross-sectional view of another nozzle fixation according to the present invention is shown.

[0060] In FIG. 1 , a schematic cross-sectional view of a nozzle fixing assembly 1 with a sealing element known in the art is shown.

[0061] Nozzle mounting assembly 1' includes an elastically deformable sealing element 2, as is known in the art. This sealing element 2 has a continuous opening 3, into which a nozzle body 4 is inserted. The depicted nozzle body 4 consists of two halves, drawn in white and black. The interface between these two halves contains a channel structure (not depicted) that connects the upstream end (bottom of the image) to the downstream end (top of the image) of the nozzle body 4.

[0062] The sealing element 2 and the nozzle body 4 have a high pressure side 2A, 4A and an outlet side 2B, 4B, respectively.

[0063] Furthermore, pressure element 5 has a high-pressure side 5A. This side 5A is arranged to face the high-pressure side 2A of the sealing element and the high-pressure side 4A of the nozzle body 2. Between sides 2A / 4A and 5A, there is a space 6, which is temporarily loaded with high-pressure liquid during actuation of the device (not depicted). Pressure element 5 is configured to allow a diversion of the liquid to be vaporized into space 6. In the example, this is achieved via a central opening 7.

[0064] In assembly 1 , high-pressure side 2A of sealing element 2 is chamfered. Viewed in the direction of longitudinal axis X (dash-dotted line), all surfaces of high-pressure side 2B of sealing element 2 are inclined toward this axis and are not perpendicular to it. Meanwhile, high-pressure side 5A of pressure element 5 is flat, i.e., its surfaces are substantially perpendicular to axis X.

[0065] exist Figure 2, a schematic cross-sectional view of a nozzle fixing assembly 1 according to the present invention is shown. In contrast to the assembly of FIG. 1 , the high-pressure side 2A of the sealing element 2 is essentially flat, i.e., it lies in a plane perpendicular to the longitudinal axis X of the sealing element 2. Furthermore, the high-pressure side 5A of the pressure element 5 is chamfered in such a way that, in the depicted assembled state, the distance between these high-pressure sides 2A, 5A is greater in the central region C than in the peripheral region P. This distance is measured parallel to the longitudinal axis X.

[0066] The depicted embodiment further includes a pot-shaped holder 8 having a recess. Within this recess are arranged the sealing element 2 with the nozzle body 4 and the pressure element 5. The holder 8 includes a low-pressure surface 8B that contacts the (low-pressure) outlet side 4B of the nozzle 4. To minimize the gap around the sealing element 2, which also must be sealed, the holder 8 has an internal profile that matches the external profile of the sealing element 2. At its high-pressure end 8A, the holder 8 contains the entire pressure element 5, which has its high-pressure side 5A.

[0067] As can be seen, outside the periphery P, the high-pressure side 5A of the pressure element 5 is only slightly in physical contact with the high-pressure side 2A of the sealing element 2. Thus, the pressure element 2 secures the sealing element 2 in its position. Similarly, if the pressure element 2 is pushed further into the recess (not shown), permanent physical pressure is exerted on the sealing element 2, causing it to deform (not depicted). However, even in the absence of any significant physical contact, when the pressure pulse enters the space 6, the further it travels toward the periphery P, the more concentrated the pulse becomes. Consequently, at the periphery P, a greater pressure is exerted than in the center C, temporarily causing the deformation again.

[0068] In both cases, the deformation is such that the wall of the continuous opening 3 in contact with the nozzle body 4 moves (permanently or temporarily) against said body, sealing it against liquid that might otherwise bypass the internal passage of the nozzle body 4 .

[0069] As can be seen, in this example, in the depicted cross-section extending along the longitudinal axis X, the chamfered surface has a straight line shape or profile. However, other profiles (not depicted) are also possible. The effect can be maintained as long as the rule that the space at the periphery is always shallower than the space in the center is followed. In the example, the high-pressure side 5A of the pressure element 5 is substantially completely chamfered.

[0070] If the outer wall of the holder 8 has a thread (not shown), the pressure element 5 can be screwed into a matching thread (not shown) of the holder 8 so that it acts as a closure for the high-pressure end 8A of the holder 8 .

[0071] Figure 3A further example of a nozzle assembly 1 is shown including an optional gasket 8. Not all reference numerals are given in this drawing.

[0072] A gasket 9 is arranged between the sealing element 2 and the two high-pressure sides 2A, 5A of the pressure element 5. The gasket 9 has a continuous opening (without reference numeral) for the fluid connection of the space 6 and the nozzle body 4.

[0073] The first side 9B for contacting the high-pressure side 2A of the sealing element 2 is substantially flat.

[0074] The opposite second side 9A, which faces the high-pressure side 5A of the pressure element 5, is chamfered in such a manner that the distance between the second side 9A and the high-pressure side 2A of the sealing element 2 is greater in the central region C than in the peripheral region P. Consequently, a gap is provided between the second side 9A of the gasket 8 and the high-pressure side 5A of the pressure element 5. The gap is narrower at its periphery P than at its center C. Thus, the above-described pressure concentration effect is maintained.

[0075] As can be seen, the second surface 9A of the gasket 9 has a profile similar to the negative image of the profile of the chamfered surface of the pressure element 5. However, other profile combinations are also possible, for example such combinations in which the aforementioned distances are larger in the center and / or smaller at the periphery compared to the depicted example.

[0076] Reference List

[0077] 1,1' nozzle fixing assembly

[0078] 2 Sealing elements

[0079] 2A high voltage side

[0080] 2B exit side

[0081] 3 continuous opening

[0082] 4 nozzle body

[0083] 4A high voltage side

[0084] 4B exit side

[0085] 5Pressure elements

[0086] 5A high voltage side

[0087] 6 Space

[0088] 7 center opening

[0089] 8 holders

[0090] 8A high voltage terminal

[0091] 8B low pressure surface

[0092] 9 washers

[0093] 9A Second Side

[0094] 9B first side

[0095] X longitudinal axis

[0096] C Central area, center

[0097] P peripheral area, peripheral

Claims

1. A medical inhaler or medical nebulizer for use with a medical fluid comprising a nozzle retaining assembly, the assembly being adapted to be substantially pressure-tight when inserted into a nozzle body, the assembly comprising: an elastically deformable sealing element having a continuous opening capable of receiving a nozzle body, the sealing element and the nozzle body each having a high-pressure side and an outlet side; a pressure element having a high-pressure side, the high-pressure side of the pressure element being arranged facing the high-pressure side of the sealing element; in (i) the high pressure side of the sealing element is substantially flat and lies in a plane perpendicular to a longitudinal axis of the sealing element, wherein the longitudinal axis follows the continuous opening, and (ii) the high-pressure side of the pressure element comprises a central area having a central opening and a peripheral area surrounding the central area, the high-pressure side of the pressure element being inclined in such a manner that, in the assembled state, the distance between the surface of the high-pressure side of the pressure element and the high-pressure side of the sealing element decreases from the central opening of the surface to the outer edge of the surface, wherein the central area is the area facing the continuous opening when following the longitudinal axis. 2 . The medical inhaler or medical nebulizer for medical fluid comprising a nozzle fixing assembly according to claim 1 , the inhaler additionally comprising the nozzle body, wherein the nozzle body is inserted into the continuous opening.

3. A medical inhaler or medical nebulizer for medical fluids comprising a nozzle fixing assembly according to claim 1 or 2, the inhaler further comprising a holder having a recess in which the sealing element and the pressure element are arranged, the holder comprising (i) a low-pressure surface which contacts the outlet side of the nozzle body in an assembled state, and (ii) an internal contour which matches the external contour of the sealing element, and (iii) a high-pressure end which contains at least the high-pressure side of the pressure element.

4. The medical inhaler or medical nebulizer for medical fluids comprising a nozzle fixing assembly according to claim 1, wherein in an assembled state, the high-pressure side of the pressure element is at least partially in physical contact with the high-pressure side of the sealing element.

5. The medical inhaler or medical nebulizer for medical fluids comprising a nozzle fixing assembly according to claim 1, wherein in an assembled state, the distance is zero in the peripheral area and is greater than zero in the central area.

6. A medical inhaler or a medical nebulizer for medical fluids comprising a nozzle fixing assembly according to claim 1, wherein in an assembled state, the high-pressure side of the pressure element is spaced apart from the high-pressure side of the sealing element so that no physical contact is established.

7. The medical inhaler or medical nebulizer for medical fluid comprising a nozzle fixing assembly according to claim 1, wherein the inclined surface of the pressure element has a straight, concave or convex profile in a cross section along the longitudinal axis.

8. A medical inhaler or a medical nebulizer for medical fluids comprising a nozzle fixing assembly according to claim 1, wherein the high-pressure side of the pressure element is substantially inclined as a whole, or has a central area that is substantially flat and parallel to the high-pressure side of the sealing element.

9. A medical inhaler or a medical nebulizer for medical fluids comprising a nozzle fixing assembly according to claim 1 , wherein in the assembled state the pressure element serves as a closure for the high-pressure end of the holder, or wherein a cap is provided which can be attached to the high-pressure end.

10. The medical inhaler or medical nebulizer for medical fluids comprising a nozzle fixing assembly according to claim 1, further comprising a gasket, the gasket being arranged between the two high-pressure sides, the gasket having one or more continuous openings for fluid connection between the space and the nozzle body, wherein the gasket has - a first side for contacting the high-pressure side of the sealing element, the first side being substantially flat, and - an opposite second side, which faces the high-pressure side of the pressure element, wherein the second side is inclined in such a way that, in the assembled state, the distance between the second side and the high-pressure side of the sealing element is higher in its central region than in its peripheral region, and - providing a gap between the second side of the gasket and the high-pressure side of the pressure element.

11. The medical inhaler or medical nebulizer for medical fluid comprising a nozzle fixing assembly according to claim 10, wherein the gap is narrower at its periphery than at its center.

12. The medical inhaler or medical nebulizer for medical fluid comprising a nozzle fixing assembly according to claim 10, wherein in a cross section along the longitudinal axis, the second side of the gasket has a profile that is a negative image of a profile of the inclined surface of the pressure element.

13. The medical inhaler or medical nebulizer for medical fluid comprising a nozzle fixing assembly according to claim 3, wherein the recess and / or the sealing element has a truncated cone shape.

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