Inverted nozzle fixture and method

Abstract

The present invention provides an apparatus for clamping a fluid component subjected to fluctuating fluid pressure, the fluid component having a downstream end, an opposite upstream end, and an outer contour, the apparatus comprising a holder, an elastomer molding, and a mating portion, the elastomer molding having at least one compensation surface, the at least one compensation surface in the assembled state not contacting the mating portion or at least one protrusion of the mating portion.

Description

[Technical Field]

[0001] The present invention is in the field of fluid components intended for inhalation devices. More particularly, the invention relates to a device for clamping small fluid components, such as nozzles, which are subjected to varying fluid pressures under normal operation. The invention further relates to an inhalation device for administering medically active liquids by inhalation, the inhalation device including such a clamping device. [Background technology]

[0002] Nebulizers or other aerosol generators for liquids have been known in the art for a long time. These devices are used, inter alia, in medicine and therapy. In this case, they function as inhalation devices for administering an active ingredient in the form of an aerosol, i.e., small droplets embedded in a gas. Such an inhalation device is known, for example, from European Patent No. 0 627 230. The essential components of this inhalation device are a reservoir containing the liquid to be aerosolized, a pump unit for generating a pressure high enough to nebulize the liquid, and an atomizing device in the form of a nozzle.

[0003] An improvement to such an inhalation device is disclosed in patent application EP 3 615 111 filed by the same applicant as the present invention, the contents of which are incorporated herein in their entirety.

[0004] To achieve a sufficiently homogeneous and fine mist of droplets, relatively high pressures are usually required, such as 10 bar or up to 100 bar or even up to 1000 bar. To keep the amount of vaporized liquid in each dose acceptably low, the atomizing nozzle usually comprises one or more channels, each of which has a diameter of a few μm. 2 Approximately, for example, 2 μm 2 to 200 μm 2 The channels are present within the nozzle body and are often fabricated using micro-engineering manufacturing techniques such as micro-etching, microlithography, etc.

[0005] However, these techniques often involve hard and brittle materials such as silicon, glass, or metal, and the nozzle body is often made of a very rigid material to avoid any undesired deformation of the nozzle body when exposed to the high pressure. However, this delicate and essential element of the entire device must be firmly fixed within the device. This involves liquid-tightness as well as mechanical safety. Therefore, fixing the nozzle body within the inhalation device requires special care.

[0006] From document EP 0 853 498 B1, a nozzle fixture is known which comprises a pot-shaped holder having an internal recess and an elastomer molding adapted to fit into this recess. The molding itself has an opening designed to receive the nozzle body. When inserted into the recess, one surface of the molding (and nozzle body) is exposed to high pressure during use. The holder has a small orifice at its base which aligns with the nozzle outlet, and the matching walls of both the holder and the molding are frustum-shaped.

[0007] A more recent document, DE 10 2004 001 451, suggests that the aforementioned solution works well at medium and high pressures, but does not provide sufficient tightness at low pressures, e.g., below 10 bar. Therefore, the latter document proposes a solution in which the holder is complemented on the high-pressure side with a counterpart that closes the holder, the counterpart having a circumferential ridge that, when assembled, displaces the elastic material of the molded body when pressed against it. Furthermore, on the high-pressure side, the molded body is not flat, but has a centrally inclined recess, resulting in a bevel or chamfer that is inclined toward the centrally located nozzle body.

[0008] Similarly, WO 03 / 097139 discloses a nozzle system for a liquid dispensing device, comprising a nozzle and a device for fixing the nozzle in the dispensing device. The nozzle fixing device can be fixed by a second fixing device, for example in the form of a cap nut. The side of the fixing device facing the nozzle outlet is provided with a specific geometric shape that minimizes the portion of the dispensed liquid that accumulates on the fixing device.

[0009] WO 2019 / 102002 discloses a nozzle fixing assembly for an inhalation device comprising an elastically deformable sealing element having a continuous opening capable of receiving a nozzle body, the high pressure sides of the sealing element being substantially flat and being chamfered such that in an assembled state the distance between the high pressure sides is greater in a central region than in peripheral regions.

[0010] The latter solution was claimed to provide increased liquid tightness even at low pressures, but its high-pressure side elastomeric deformable seal is exposed to the sprayed liquid, which has proven to be a disadvantage, especially for certain combinations of elastic seal material and sprayed liquid.

[0011] The object of the present invention is to provide a device that avoids the drawbacks of the known art. In particular, the nozzle fixture should be sufficiently liquid-tight throughout the typical pressure range of an inhalation device, and the components should be easy to manufacture and assemble. Furthermore, direct contact between the elastomeric sealing material and the liquid to be sprayed should be minimized. [Prior art documents] [Patent documents]

[0012] [Patent Document 1] European Patent No. 0 627 230 [Patent Document 2] European Patent No. 3 615 111 [Patent Document 3] European Patent No. 0 853 498 [Patent Document 4] DE 10 2004 001 451 A1 [Patent Document 5] International Publication No. 03 / 097139 [Patent Document 6] International Publication No. 2019 / 102002 Summary of the Invention

[0013] In a first aspect, the present invention relates to an apparatus (10) for clamping a fluid component (20) subjected to a fluctuating fluid pressure, said fluid component (20) having a downstream end (21), an opposite upstream end (22) and an outer contour (23), said apparatus comprising: - a holder (30) having a downstream end (31) and an opposite upstream end (32) and an inner contour (33), in which, in an assembled state, a fluid component is placed inside the holder, the downstream end (21) of the fluid component (20) being supported by the downstream end (31) of the holder; - an elastomeric molding (40) having a downstream end (41) and an opposite upstream end (42) and an inner contour (43) and an outer contour (44), the inner contour (43) of the elastomeric molding (40) surrounding and contacting the outer contour (23) of the fluid component; - a fitting (50) adapted to be fixed to the upstream end (32) of the holder (30), the fitting (50) having a downstream end (51) and an opposite upstream end (52) and an outer contour (53), the outer contour (52) of the fitting being adapted to the inner contour (33) of the holder, the fitting (50) comprising at least one protrusion (55) that projects into the holder and contacts and deforms the elastomeric molding; Including, The elastomeric molding comprises at least one compensation surface (45), which in the assembled state does not come into contact with the mating part or the at least one projection of the mating part.

[0014] In a second aspect, the present invention provides a fluid assembly, such as a nozzle assembly, comprising an apparatus for clamping a fluid component, such as a nozzle, according to the first aspect of the invention, and a fluid component, in particular a nozzle, clamped by the apparatus.

[0015] In a third aspect, the present invention provides an inhalation device for administering by inhalation a medically active liquid in atomized form, the inhalation device comprising a device according to the first aspect of the invention, more particularly a fluid assembly according to the second aspect of the invention.

[0016] In a fourth aspect, the present invention relates to a method for clamping a fluidic component, in particular a nozzle such as an impingement nozzle, or in other words a method for the preparation of a fluidic assembly according to the second aspect of the invention, comprising: a) An apparatus for clamping fluid components according to a first aspect of the invention, comprising: - holder, - an elastomer molding having at least one compensation surface; - fluid components, in particular nozzles such as impingement nozzles, and - a mating portion having at least one protrusion providing a part of the apparatus comprising: b) assembling the device, b1) introducing an elastomer molding into a holder and subsequently introducing a fluid component into the elastomer molding; or b2) introducing the fluid component into the elastomer molding, and then introducing the elastomer molding holding the fluid component into the holder. and assembling the c) compressing the elastomeric molding by fixing the fitting in a holder, thereby bringing at least one protrusion of the fitting into contact with (the upstream surface of) the elastomeric molding; The present invention provides a method comprising: [Brief explanation of the drawings]

[0017] [Figure 1]1 shows an apparatus for clamping a fluid component having an elastomeric molding with a compensating surface facing the fluid component and the fluid component introduced into the elastomeric molding before final assembly. [Figure 2] 2 shows the device of FIG. 1 and a fluid assembly according to the invention in a final assembled state. [Figure 3] 1 shows a device for clamping a fluid component with an elastomer molding having a compensation surface facing the inner contour of the holder before assembly. [Figure 4] 4 shows the device of FIG. 3 and a fluid assembly according to the invention in a final assembled state. [Figure 5] 1 shows a device for clamping a fluid component with an elastomer molding having an internal compensation surface in the form of a hollow space located inside the elastomer molding before assembly. [Figure 6] 6 shows the device of FIG. 5 and a fluid assembly according to the invention in a final assembled state. [Figure 7] 1 shows a perspective view of one embodiment of a fitting having a continuous circular protrusion.

[0018] [Figure 8] 1 illustrates a perspective view of one embodiment of a fitting having multiple protrusions arranged in the form of discontinuous circular rings. [Figure 9] 1 shows a schematic cross-sectional view of an exemplary inhalation device for inhalation administration of a medically active liquid in atomized form, comprising a clamping device for clamping fluid components. DETAILED DESCRIPTION OF THE INVENTION

[0019] In a first aspect, the present invention provides an apparatus for clamping a fluid component subjected to fluctuating fluid pressure, the fluid component having a downstream end, an opposite upstream end, and an outer contour, the apparatus comprising: a holder having a downstream end and an opposite upstream end and an inner contour, wherein, in an assembled state, the fluid component is disposed inside the holder and the downstream end of the fluid component is supported by the downstream end of the holder; and - an elastomeric molding having a downstream end and an opposite upstream end and an inner contour and an outer contour, the inner contour of the elastomeric molding surrounding and contacting the outer contour of the fluid component; - a fitting adapted to be fixed to the upstream end of the holder, the fitting having a downstream end and an opposite upstream end and an outer contour, the outer contour of the fitting being adapted to an inner contour of the holder, the fitting comprising at least one protrusion, the protrusion projecting into the holder and contacting and deforming the elastomeric molding (in the final assembled state); Including, The elastomeric molding comprises at least one compensation surface, which in the assembled state does not contact the mating portion or the at least one protrusion of the mating portion.

[0020] Alternatively stated, according to a first aspect, the present invention provides an apparatus for clamping a fluid component subjected to fluctuating fluid pressure, said fluid component having a downstream end, an opposite upstream end and an outer contour, said apparatus comprising: a holder having a downstream end and an opposite upstream end and an inner contour, wherein, in an assembled state, the fluid component is disposed inside the holder and the downstream end of the fluid component is supported by the downstream end of the holder; and - an elastomeric molding having a downstream end and an opposite upstream end and an inner contour and an outer contour, the inner contour of the elastomeric molding surrounding and contacting the outer contour of the fluid component; - a fitting adapted to be fixed to the upstream end of the holder, the fitting having a downstream end and an opposite upstream end and an outer contour, the outer contour of the fitting being adapted to an inner contour of the holder, the fitting comprising at least one protrusion, the protrusion projecting into the holder and contacting and deforming the elastomeric molding (in the final assembled state); Including, The elastomeric molding includes at least one compensation surface, the at least one compensation surface being located at the downstream end of the elastomeric molding or within the elastomeric molding.

[0021] In other words, in this alternative description, the first aspect of the invention relates to a device as defined above, in which at least one compensating surface is not located at the upstream end of the elastomeric moulding.

[0022] The device according to this first aspect of the present invention (hereinafter also referred to as "clamping device") is suitable for clamping, in other words, fixing or firmly holding a fluid component. The term "fluid component" as used herein can be broadly understood as a component that can be used or incorporated into a fluidic device for the delivery, administration, or transport of a fluid or liquid, particularly a fluidic device for medical purposes, such as a pump for a medically active liquid or fluid, an inhalation device nebulizer, etc. In the context of the present invention, a preferred fluid component is a component for an inhalation device, specifically a nebulizer for aerosolizing and administering a medically active liquid in nebulized or aerosolized form. In certain embodiments, such a nebulizer can include a microfabricated part, such as a nozzle for nebulizing or aerosolizing a liquid.

[0023] Thus, in certain embodiments of the device, the fluid component is a nozzle for atomization or aerosolization of a liquid. In even more specific embodiments, the fluid component is a nozzle for atomization or aerosolization (used interchangeably herein) of a medically active liquid to be administered by inhalation to a subject in need thereof, as described in more detail below. In even more specific embodiments, the fluid component, or more specifically, the nozzle, may be of the type used in so-called soft mist inhalers (SMIs) and configured to emit at least two jets of a liquid that collide to form an aerosol of droplets dispersed in the air. Such impingement nozzles are adapted to function at relatively high pressures, such as in the range of about 10 bar to about 100 bar, or even about 300 bar, although the pressure is typically generated by a pump unit instead of a pressurized gas or other propellant. An example of that type of inhalation device is described in WO 2018 / 197730, the entire contents of which are incorporated herein by reference. Thus, in certain embodiments, the fluid component clamped or secured by the device of the present invention is an impingement nozzle.

[0024] In certain embodiments, fluid components clamped or secured by the device of the present invention may be microfabricated or miniaturized components, and may have small external dimensions, typically ranging from a few centimeters to 1 mm or less, as appropriate. Thus, typical dimensions of nozzles, particularly the impingement nozzles described above, range from about 2 mm to about 20 mm, for example, relative to the longest side of a rectangular parallelepiped structure. Fluid components clamped or secured by the device of the present invention can have a variety of shapes, such as cylindrical or rectangular, or truncated conical. However, in certain embodiments, the fluid components have a cylindrical or rectangular shape. Fluid components clamped by the clamping device of the present invention, particularly the nozzles or impingement nozzles described above, are typically hard and wear-resistant, and in certain cases are fabricated from brittle materials such as glass or silicon.

[0025] Due to the miniaturized dimensions, not only single but also multiple fluid components such as those described above may be clamped or secured by the device of the present invention. In that regard, the term "fluid component" as used herein also refers to a single fluid component of multiple identical or different fluid components. Thus, in certain embodiments, the device of the present invention is adapted to clamp multiple components, such as two to four components, or two or three components, specifically two components.

[0026] Under normal circumstances, fluid components clamped by the device of the present invention are subjected to fluctuating or even rapidly fluctuating fluid pressures, for example, up to 200 bar or more, applied to the fluid component, specifically the nozzle, with a sudden drop in pressure immediately upon expulsion of the liquid or fluid dispensed by the fluid component from the nozzle. However, in general, the term "fluctuating fluid pressure" as used herein should be understood broadly to mean that the pressure exerted on the fluid component is not constant but varies (increases or decreases) over time, either continuously or discontinuously, while the pressure change may be a single event or may be repeatedly applied to the fluid component, as in the case of the nozzle of the suction device described above.

[0027] The device according to the invention is preferably adapted to be substantially gas-tight and liquid-tight, meaning that no leakage or only very small, negligible leakage is desired despite the typically high pressures that may be applied to a fluid component such as a nozzle during normal use, in particular the device is adapted to be gas-tight and liquid-tight when a fluid component such as a nozzle body is inserted, i.e. when the device is in an assembled state as described in more detail below.

[0028] Fluid components clamped or secured by the apparatus of the present invention have a downstream end and an opposite upstream end. The terms "downstream" and "upstream" as used herein with respect to various components of the apparatus should be understood to define opposite sides or ends of the respective components relative to the direction in which fluid or liquid is delivered or conveyed relative to the fluid component, with "downstream" referring to the side or direction in which the fluid or liquid is delivered and "upstream" referring to the side or direction in which the fluid or liquid is delivered.

[0029] When the fluid component is a nozzle, as described above, the upstream side or end of the nozzle receives high pressure from the liquid to atomize the fluid or liquid, and thus may be referred to as the "high-pressure" side. The liquid to be aerosolized or atomized is typically forced through one or several channels, such as an inlet channel, which may include a filter or the like. The opposite end of the channel terminates at the actual nozzle outlet, where an inhalable mist is generated upon activation of the device. This downstream end is surrounded by ambient pressure and may therefore be referred to as the "low-pressure" side.

[0030] Furthermore, the fluid component has an outer contour or surface, which may be understood as one or more outer faces or sidewalls of the fluid component extending between the upstream end and the opposite downstream end of the fluid component. Depending on the general design and geometry of the fluid component described above, the contour may be generally circular or elliptical (e.g., when the fluid component has a cylindrical or frusto-conical shape), or may have multiple substantially flat sidewalls (e.g., when the fluid component has a rectangular or polygonal shape). In certain embodiments, the fluid component has a cylindrical or rectangular shape. Furthermore, the contour or outer surface of the fluid component may have an irregular shape, such as a star shape.

[0031] The device of the present invention further comprises a holder having a downstream end and an opposite upstream end (as defined above in connection with the fluid component). The holder further has an inner contour or inner surface, which should be understood as the inner contour or surface of the holder's sidewall extending from the downstream end to the upstream end of the holder. In certain embodiments, particularly when the clamping device of the present invention is implemented in an inhalation device such as a handheld inhalation device, the holder can have an outlet opening located at the downstream end through which the dispensed liquid or fluid can be discharged. Generally, the holder can have a variety of external shapes, such as an overall rectangular, cylindrical, polygonal, or irregular shape, but the upstream end of the holder is preferably open, resulting in an overall cup-like or bowl-like shape that allows for the introduction of additional components, such as a fluid component or an elastomeric molding or fitting, as described below. In certain embodiments, the holder is open, or in other words, has an access opening at its upstream end or upstream side across its entire inner diameter, thereby allowing access to the holder's internal cavity. Thus, the fluid component and additional components of the device can be inserted into the holder through the access opening.

[0032] In the assembled state, the fluid component is positioned inside the holder such that the downstream end of the fluid component is supported by the downstream end of the holder. In certain embodiments, particularly when the fluid component is a nozzle secured within an inhalation device, the fluid component may be positioned within the holder such that the nozzle's ejection channel is co-located with the holder's outlet opening, enabling ejection and atomization of liquid. The term "supported by the downstream end of the holder" in relation to a fluid component means that the fluid component may directly contact the downstream end (inner contour or surface) of the holder or may indirectly contact the holder, for example, via an additional seal or other connection and / or buffer structure disposed between the fluid component and the downstream end (inner contour) of the holder. In certain embodiments, the holder may include means for establishing a connection to a mating portion, for example, by establishing a form-fit or press-fit connection, such as a snap-fit ​​connection, or by a screw thread, as described in more detail below, although such means may preferably be located at the upstream end of the holder.

[0033] The device of the present invention further includes an elastomeric molding having a downstream end and an opposite upstream end (as defined above in relation to the fluid component). The elastomeric molding can have a generally ring-like shape with an inner opening that can accommodate the fluid component and be clamped or secured after final assembly of the device. The outer surface or contour of the elastomeric molding can generally be adapted to the inner contour of the holder, and more specifically, as described in more detail below, has a size and shape that fits into the inner lumen of the holder both before assembly and in the assembled state of the device. Thus, in certain embodiments, the total volume of the elastomeric molding is equal to or less than the total volume of the inner lumen of the holder. Due to its generally ring-like shape, after insertion of the fluid component, the elastomeric molding has an inner contour or surface that surrounds and contacts the outer contour of the fluid component, preferably around the entire circumference of the fluid component, after assembly or final assembly of the device. However, before assembly, the cross-section of the inner opening of the elastomeric molding may be slightly larger than the cross-section of the fluid component to be enclosed or secured. For example, the cross-sectional diameter of the inner opening may be about 10 μm to about 2 mm or about 1 mm larger than the corresponding cross-sectional diameter of the fluidic component.

[0034] However, as described in more detail below, the outer surface or contour of the fluid component may or may not completely contact the inner contour of the elastomeric molded portion, particularly prior to final assembly of the device or fluid assembly. In certain embodiments, the entire outer contour of the fluid component (corresponding to the surface of the fluid component's sidewall) contacts the inner contour of the elastomeric molded portion. However, in alternative embodiments, when the fluid component is introduced into the elastomeric molded portion, but before the device is assembled as described in more detail below, only about 50% to about 99%, or about 60% to about 95%, or about 70% to about 90% of the outer contour or surface of the fluid component contacts the inner surface of the elastomeric molded portion.

[0035] In certain embodiments, the elastomeric molding is made of an elastically deformable material that can deform when subjected to external pressure applied to the outer surface of the elastomeric molding, such as a deformation pressure applied by at least one protrusion of the mating portion, as described in more detail below. In further specific embodiments, the elastomeric molding is made of a material with a low compressibility that allows pressure applied to one side or surface of the elastomeric molding to be transmitted to its other or other surface. In other words, depending on the compressibility of the elastomeric molding, deformation of one surface or side of the elastomeric molding results in expansion of another surface or side of the same element, preferably expansion of at least one compensating surface, as described in more detail below.

[0036] Thus, the elastomeric molding may comprise or consist essentially of a wide variety of elastomeric materials, such as fluoropolymer materials, e.g., Viton®, nitrile butadiene rubber (NBR), ethylene propylene diene monomer rubber (EPDM), polytetrafluoroethylene (PTFE), synthetic rubbers such as silicone or liquid silicone rubber (LSR).

[0037] The device according to the present invention further comprises a fitting adapted to be secured to the upstream end of the holder, and in certain embodiments, secured to the upstream end of the holder in the final assembled state of the device. The fitting has a downstream end, an opposite upstream end, and an outer contour or surface. The outer contour or surface of the fitting is adapted to the inner contour of the holder, specifically the inner contour of the holder surrounding the access opening of the holder. As described above, the fitting can be secured to the holder, particularly by inserting the fitting into the access opening of the holder. In certain embodiments, the connection of the fitting to the holder can be established by a form-fit or press-fit connection, specifically a snap-fit ​​connection or a screw thread, but for example, the fitting can be screwed into the (access opening) of the holder. Thus, the inner cavity of the holder can be closed and further reduced by securing the fitting to the holder as described above. The term "finally assembled" as used herein refers to the state of the clamping device when all of the parts of the device have been assembled and the fittings have been secured to the holder, i.e., the device is ready for use. However, the term "assembled" as used herein refers to the state of the device when all of the parts of the device have been assembled and the fittings have not yet been secured to the holder.

[0038] In certain embodiments, during assembly of a device according to the present invention, the elastomeric molding can be introduced into the holder through an access opening in the holder, followed by introducing the fluid component into the inner opening of the elastomeric molding. Alternatively, the fluid component can be inserted into the inner opening of the elastomeric molding, and then the assembled elastomeric molding and fluid component can be introduced into the inner cavity of the holder. In either case, after the elastomeric molding and fluid component are introduced into the holder through the access opening, the access opening can be closed by securing the mating portion to the holder as described above.

[0039] In some embodiments, the mating portion can have a generally flat shape, such as a rectangular or square board or a circular, oval, or even irregular disk. However, in certain embodiments, particularly when the mating portion has threads for establishing a connection to the holder, the mating portion may have the form of a flat disk with a round circumference for fitting into a corresponding round access opening in the holder. The mating portion can also have a fluid opening that allows access for the fluid to be delivered or sprayed into a fluid component, such as a nozzle.

[0040] The fitting further comprises at least one protrusion disposed on the downstream end, more specifically, on the surface of the downstream end of the fitting and attached to the downstream end. Thus, in the final assembled state, or in other words, when the fluid element and the elastomeric molding are introduced into the holder (the lumen) and the fitting is secured to the holder, the protrusion protrudes into the holder and contacts and deforms the elastomeric molding housed in the holder. In certain embodiments, the at least one protrusion contacts and deforms the upstream portion of the elastomeric molding, causing the elastomeric molding to be deformed and / or compressed, as described in more detail below.

[0041] The at least one protrusion located on the downstream surface of the mating portion may generally have a different form or shape suitable for deforming and compressing the elastomeric molded portion. In other words, a suitable shape of the at least one protrusion is mechanically stable enough to compress and deform the elastomeric molded portion under the pressure applied by the mating portion when secured to the holder. Furthermore, a suitable shape of the protrusion allows for effective compression and deformation of the elastomeric molded portion, for example, without puncturing the elastomeric molded portion. However, in some embodiments, particularly when multiple protrusions having different or irregular shapes are implemented, some degree of puncturing of the elastomeric molded portion may be advantageous to enable fixation of the elastomeric molded portion. In certain embodiments, as already mentioned above, the protrusion may be in the form of a single protrusion or in the form of multiple protrusions, for example, 2 to about 100, or about 75, or about 50 protrusions, or 2 to 25 protrusions, for example, 2 to about 20, or 3 to about 15, or about 4 to about 10 protrusions.

[0042] In the case of multiple protrusions, the protrusions may have the same form or shape, or may have different forms or shapes independently of one another. Suitable forms or shapes include, but are not limited to, dots, rings, bars, e.g., parallel bars, or intersecting bars, e.g., honeycomb structures, and irregular shapes. Rings and bars may be continuous or discontinuous, such as multiple bars oriented radially relative to the central major axis of the device. When provided in the form of a ring or multiple rings, the rings may preferably have a circular shape centered on the major longitudinal axis of the device connecting the downstream end (center) of the device with the upstream end (center) of the device. In certain embodiments, at least one protrusion of the mating portion may have the form of at least one annular ring. In further specific embodiments, the multiple annular rings may have different diameters and may be concentrically arranged around the same center. In further embodiments, at least one protrusion may have the form of a meandering line, either circular or non-circular, such as a collar.

[0043] In some embodiments, at least one protrusion of the fitting can have a uniform or continuous height measured from the downstream face of the fitting, regardless of the general shape as described above with respect to the horizontal dimension, i.e., horizontally relative to the major axis of the device as described above. In further embodiments, at least one protrusion can have a non-uniform height, meaning that in the case of a single protrusion, such as an annular ring, the protrusion can have a varying height, or in the case of multiple protrusions, the protrusions can have different heights measured from the downstream face of the fitting.

[0044] Furthermore, at least one protrusion can have different cross-sectional shapes when viewed in a vertical cross section, i.e., along a plane perpendicular to the downstream end of the mating portion. In some embodiments, at least one protrusion can have, for example, a rounded, pointed, cubic, or trapezoidal shape that defines a width at the upstream end of the protrusion (contacting the downstream surface) of the mating portion, and an equal or different, i.e., smaller, width at the opposite downstream end. In certain embodiments, the height of at least one protrusion (as measured from the downstream end of the mating portion) can be in the range of about 100 μm to about 20 mm, e.g., about 500 μm to about 6 mm, or about 500 μm to about 2 mm. In even more specific embodiments, the maximum width of at least one protrusion, i.e., the width at the base of the protrusion facing the downstream end of the mating portion, can be in the range of about 100 μm to about 20 mm, e.g., about 500 μm to about 6 mm, or about 500 μm to about 2 mm. In a further particular embodiment, the plurality of protrusions have equal heights and / or widths.

[0045] Thus, the at least one protrusion as defined above may have a total volume Vp, which should be understood as the overall internal volume of a single protrusion measured from the downstream face of the mating portion, or in the case of multiple protrusions as the sum of the individual volumes of the multiple protrusions.

[0046] The holder and, independently thereof, the fitting with the at least one protrusion may be made of a material with sufficient mechanical stability or rigidity, such as a metal like stainless steel or a thermoplastic polymer, which allows for the manufacture of the respective parts by injection molding. In certain embodiments, the holder and / or the fitting and / or the at least one protrusion comprise or consist essentially of stainless steel, polyethylene, polystyrene, polyetheretherketone (PEEK), acrylonitrile butadiene styrene (ABS), polycarbonate and polyamide, in particular PEEK.

[0047] The elastomeric molding of the device according to the invention comprises at least one compensation surface. As used herein, the term "compensation surface" of the elastomeric molding defines a surface or contour of the elastomeric molding that, after the elastomeric molding and the fluid component are introduced into the holder as described above, but before the access opening of the holder is closed by fastening the fitting to the (upstream end) of the holder (i.e., in the assembled state), does not contact the inner surface of the holder or the outer surface of the fluid component, thereby defining a hollow space (hereinafter referred to as a "compensation volume") into which the elastomeric molding can expand when compressed by the fitting and / or at least one protrusion of the fitting (in the final assembled state).

[0048] In an equivalent description, the compensation surface is a surface or surface area of ​​the elastomer molding that is not in contact with the inner surface of the holder and / or the outer surface of the fluid component in the assembled state (when the elastomer molding and the fluid component are introduced into the holder), but that is in contact with the inner surface of the holder and / or the outer surface of the fluid component in the final assembled state when the fitting is fixed to the holder, thereby deforming and compressing the elastomer molding.

[0049] In yet another equivalent description, the term "compensating surface" refers to a surface or surface area of ​​an elastomeric molding that is deformable, more specifically expandable, upon contact and deformation of the elastomeric molding by a mating portion (in the final assembled state). However, as explained in more detail below, the compensating surface does not contact the mating portion or at least one projection of the mating portion.

[0050] It should be noted that the compensation surfaces referred to in this specification allow for effective, pressure- and liquid-tight clamping and fixing of fluid components held by the elastomeric molding, without the risk of deformation or damage to the particulate and often delicate fluid components, especially when such fluid components are made of brittle materials such as glass or silicon.

[0051] In certain embodiments, the compensation surface is located at the downstream (low pressure) end of the elastomeric molding. In further certain embodiments, the compensation surface is formed by at least a portion of the downstream surface of the elastomeric molding being inclined or sloped or chamfered (with respect to a plane perpendicular to the major axis of the device) towards the inner and / or outer contour of the elastomeric molding.

[0052] The terms "inclined" or "sloped" or "chamfered" as used in this context mean that the distance (perpendicular to the main axis of the device) between the compensating surface and either the outer surface of the fluid component (if the compensating surface faces the fluid component) or the inner surface of the holder (if the compensating surface faces the holder) is, as the case may be, greater at the downstream end and decreases continuously or discontinuously, for example linearly, from the downstream end to the upstream end after the elastomeric molding is introduced into the holder but before the fitting is fixed to the holder.

[0053] Thus, the elastomeric molding can have one compensating surface or multiple compensating surfaces. For example, in some embodiments, the downstream surface of the elastomeric molding (before assembly of the apparatus as described above) can be inclined, sloped, or chamfered toward the inner contour of the elastomeric molding, resulting in a hollow space (i.e., compensation volume) bounded by the holder, elastomeric molding, and fluid components. In further embodiments, the downstream surface of the elastomeric molding (before assembly of the apparatus as described above) can be inclined, sloped, or chamfered toward the outer contour of the elastomeric molding, resulting in a hollow space (i.e., compensation volume) bounded only by the holder and elastomeric molding. In yet another particular embodiment, the downstream surface of the elastomer molding (before the device is assembled) may be inclined, sloped or chamfered towards the inner contour of the elastomer molding and towards the outer contour of the elastomer molding, resulting in two hollow spaces (or compensation volumes) separated from each other and confined by either the holder, the elastomer molding and the fluid component, or only by the elastomer molding and the holder.

[0054] The term "compensation volume" as used herein may also be understood to refer to a hollow space defined and limited by the compensation surface of the elastomer molding that does not contact the inner surface of the holder or the outer surface of the fluid component after the elastomer molding and the fluid component have been introduced into the holder as described above, but before the access opening of the holder is closed by fixing the fitting to (the upstream end of) the holder, thereby defining a hollow space into which the elastomer molding can expand when compressed by the fitting and / or at least one protrusion of the fitting.

[0055] In further specific embodiments, the compensation surface of the elastomeric molding can be an internal space or volume disposed within the elastomeric molding, or an internal surface formed by multiple internal spaces or volumes. Thus, in certain embodiments, the compensation surface is formed by at least one hollow space disposed within the elastomeric molding, and in certain embodiments, does not contact the ambient atmosphere, the outer surface of the fluid component, or the inner surface of the holder, or, in other words, is completely surrounded by the material of the elastomeric molding. In these cases, the compensation volume defined above can be referred to as an "internal compensation volume," and correspondingly, the compensation surface can be referred to as an "internal compensation surface."

[0056] In some embodiments, the internal compensation volume within the elastomeric molding may be a single hollow space, such as an internal channel that surrounds the inner contour of the elastomeric molding. Thus, in certain embodiments, the internal compensation volume is formed by a hollow annular space disposed within the elastomeric molding.

[0057] In other particular embodiments, the internal compensation volume may be in the form of a plurality of individual hollow spaces, e.g., spherical or elliptical hollow spaces distributed within the elastomeric molding, or may be aligned, for example, along a circumference surrounding the inner contour of the elastomeric molding.

[0058] In further particular embodiments, the internal compensation volume or volumes may have one or more channels connecting the internal compensation volume to the ambient atmosphere to provide pressure compensation within the internal compensation volume.

[0059] It should be noted that if the compensating surface is an internal compensating surface, the outer contour or surface of the elastomeric molding may be molded to completely fill the internal volume of the holder, in other words, no (external) compensating surface is required. However, in other embodiments, it may be advantageous to combine at least one (external) compensating surface with at least one internal compensating surface.

[0060] As described above for at least one protrusion, the compensation volume or internal compensation volume defined above can have a total volume Vc, which should be understood as the overall internal volume of a single compensation volume or internal compensation volume, or, in the case of multiple compensation volumes and / or internal compensation volumes, as the sum of the individual volumes of the multiple internal compensation volumes. Typically, the total volume Vc may be selected within a range of about 5% to about 80%, or about 15% to about 30% of the total volume of the elastomeric molding.

[0061] According to the invention, the at least one compensation surface (in the fully assembled state of the device, or in other words in the fluid assembly according to the invention) does not come into contact with the fitting and / or the at least one protrusion of the fitting, in other words, as mentioned above, the at least one compensation surface is located at the downstream end of the elastomeric molding or inside the elastomeric molding.

[0062] In certain embodiments, the at least one compensation volume or surface does not contact the mating portion and at least one protrusion of the mating portion, preferably, in the case of multiple protrusions, all of the multiple protrusions. In other embodiments, the at least one compensation volume or surface does not contact the mating portion or at least one protrusion of the mating portion, preferably, in the case of multiple protrusions, all of the multiple protrusions.

[0063] In other words, once the elastomeric molding and the fluid component contained therein are introduced into the holder, the holder may be closed, and the device of the present invention, more specifically, the fluid assembly including the device and the fluid component, may be completed by attaching or fixing the fitting to the holder without the fitting and / or at least one protrusion contacting any of the compensation surfaces or volumes of the elastomeric molding. As also described above, at least one protrusion of the fitting protrudes into the holder and contacts the (upstream surface) of the elastomeric molding. While attaching or fixing the fitting to the holder, the at least one protrusion of the fitting compresses the elastomeric molding, so that the fluid element surrounded by the (inner surface of) the elastomeric molding is firmly clamped and fixed within the elastomeric molding, and the compensation surface is deformed so that the corresponding compensation volume is reduced or completely filled.

[0064] However, it has surprisingly been found that if the compensating volume or surface is not located at the upstream end of the elastomeric molding, the fluid component can be effectively secured without risk of damaging or deforming the fluid component. Thus, in certain embodiments of the present device, the compensating surface of the elastomeric molding is not located at the upstream end of the elastomeric molding.

[0065] As already mentioned above, the compensation surface may be located at the downstream end of the elastomeric molding, and may be formed by at least a portion of the downstream surface of the elastomeric molding being inclined, sloped, or chamfered (with respect to a plane perpendicular to the main axis of the device) toward the inner and / or outer contour of the elastomeric molding. In other embodiments, as also mentioned above, the compensation surface may be defined by a hollow space within the elastomeric molding (as an internal compensation surface). In both cases, at least one compensation surface of the elastomeric molding provides a space or compensation volume into which the elastomeric molding can expand when compressed by the mating portion and / or at least one protrusion of the mating portion.

[0066] In certain embodiments, the surface, or more specifically the entire surface of the upstream end of the elastomeric molding, contacts the downstream surface of the mating portion and / or at least one protrusion, but since a compensation surface or volume is not located at the upstream end of the elastomeric molding, the mating portion, or more specifically the downstream surface of the mating portion and / or at least one protrusion located thereon, does not contact said compensation area or surface.

[0067] In further specific embodiments where the elastomeric molding includes a compensating surface and optionally an additional internal compensating surface as defined above, all other outer surfaces of the elastomeric molding are surrounded by and in contact with the internal surface of the holder or fitting. In still further specific embodiments where the elastomeric molding includes only an internal compensating surface as defined above, all outer surfaces of the elastomeric molding are surrounded by and in contact with the internal surface of the holder or fitting.

[0068] Regardless of the specific location of the compensation surface as described above according to the present invention, the internal pressure generated within the elastomeric molding when compressed by at least one protrusion of the fitting portion can be effectively and uniformly distributed throughout the entire elastomeric molding portion by allowing the elastomeric molding portion to expand into a compensation volume or internal compensation volume generated by an internal compensation surface that is not in contact with the compensation surface or the fitting portion or at least one protrusion, in other words, located away from the upstream surface of the elastomeric molding portion that is deformed by the fitting portion or its at least one protrusion.

[0069] In further particular embodiments of the device according to the invention, at least one protrusion has a total volume Vp, the compensation volume or internal compensation volume has a total volume Vc, and the total volume Vp of at least the protrusions is matched to the total volume Vc of the compensation volume or internal compensation volume. In further particular embodiments, the total volume Vp of at least the protrusions (in sum) amounts to at least about 10% of the total compensation volume Vc, for example, from about 10% to about 50%, or from about 20% to about 30%.

[0070] As described above, the device according to the present invention allows for effective clamping of fluid components, particularly nozzles, in a reliable, pressure-tight, and accurate manner within the inhalation device, particularly when the inhalation device is a handheld device and the fluid component is a miniaturized multi-channel impingement nozzle that is clamped and secured within a soft mist inhalation device operating at fluid pressures of at least 10 bar, often in the range of about 50 to about 250 bar. Surprisingly, fluid components such as miniature nozzles can be effectively clamped by the elastomeric molding when neither the mating portion nor the protruding portion is in direct contact with the compensating surface, and this design has proven beneficial to the assembly process, particularly for delicate fluid components such as nozzles, when the fluid component is assembled with or introduced into the elastomeric molding prior to insertion into the holder.

[0071] In a further aspect, the present invention provides a fluid assembly, such as a nozzle assembly, comprising an apparatus for clamping a fluid component, such as a nozzle, according to the first aspect of the invention as described in detail above, and a fluid component, in particular a nozzle, clamped by the apparatus.

[0072] Accordingly, the present invention provides a fluid assembly comprising a device for clamping a fluid component subjected to varying fluid pressure, said fluid component having a downstream end, an opposite upstream end and an outer contour, said device comprising: a holder having a downstream end and an opposite upstream end and an inner contour, wherein, in an assembled state, the fluid component is disposed inside the holder and the downstream end of the fluid component is supported by the downstream end of the holder; and - an elastomeric molding having a downstream end and an opposite upstream end and an inner contour and an outer contour, the inner contour of the elastomeric molding surrounding and contacting the outer contour of the fluid component; - a fitting adapted to be fixed to the upstream end of the holder, the fitting having a downstream end and an opposite upstream end and an outer contour, the outer contour of the fitting being adapted to the inner contour of the holder, the fitting comprising at least one protrusion, the protrusion projecting into the holder and contacting and deforming the elastomeric moulding (in the final assembled state), the elastomeric moulding comprising at least one compensating surface, the at least one compensating surface in the assembled state not contacting the fitting or the at least one protrusion of the fitting; Fluid parts such as nozzles clamped by a clamping device Includes:

[0073] It should therefore be noted that all definitions, features, embodiments and combinations thereof described above in relation to the device of the first aspect of the invention (or alternatives to the first aspect of the invention) apply to the fluidic assembly of the second aspect and all further aspects.

[0074] In particular embodiments, the fluid assembly of this aspect of the invention corresponds to a device for clamping a fluid component, such as a nozzle according to the first aspect of the invention, with the fluid component, in particular a nozzle, clamped by the device, and therefore corresponds to a device according to the first aspect of the invention in its final assembled state as described above. In further particular embodiments, the fluid assembly may be a nozzle assembly including a nozzle holder in the form of a device according to the first aspect of the invention with a nozzle fixture clamped therein. Such a nozzle assembly may be advantageously incorporated into inhalation devices, such as inhalation devices for administering medically active liquids, which are typically provided with nozzle structures subjected to rapidly fluctuating pressures.

[0075] Thus, in a further aspect, the present invention provides an inhalation device for inhalation administration of a medically active liquid in atomized form, the inhalation device comprising a device according to the first aspect of the invention, more particularly a fluid assembly or nozzle holder according to the second aspect of the invention.

[0076] In certain embodiments, the inhalation device of this aspect of the invention may be a handheld inhalation device, specifically a soft mist inhaler (SMI) comprising an impingement type nozzle having at least two channels through which two jets of medically active liquid are ejected, the trajectories of the at least two channels intersecting such that when ejected at high pressure the medically active liquid is atomized at the intersection.

[0077] In a still further aspect, the present invention relates to a method for clamping a fluidic component, in particular a nozzle such as an impingement nozzle, or in other words a method for the preparation or manufacture of a fluidic assembly according to the second aspect of the invention, comprising: a) a device for clamping a fluid component as described above in relation to the first aspect of the invention, comprising: - holder, - an elastomer molding having at least one compensation surface; - fluid components, in particular nozzles such as impingement nozzles, and - a mating portion having at least one protrusion providing a part of the apparatus comprising: b) assembling the device, b1) introducing an elastomer molding into a holder and subsequently introducing a fluid component into the elastomer molding; or b2) introducing the fluid component into the elastomer molding, and then introducing the elastomer molding holding the fluid component into the holder. and assembling the c) compressing the elastomeric molding by fixing the fitting in a holder, thereby bringing at least one protrusion of the fitting into contact with (the upstream surface of) the elastomeric molding; The present invention provides a method comprising:

[0078] As described above, the method according to this aspect of the invention and the apparatus of the first aspect of the invention allow for advantageous assembly of clamping devices, and more particularly fluid assemblies of the invention, such that the clamping force required to secure the fluid components is evenly distributed within the elastomeric moulding, thus allowing for air-tight and liquid-tight clamping of the fluid components while minimising mechanical stress on the (potentially fragile and delicate) fluid components.

[0079] Below is a list of numbered items that are embodiments encompassed by the present invention.

[0080] 1. A device (10) for clamping a fluid component (20) subjected to fluctuating fluid pressure, said fluid component (20) having a downstream end (21), an opposite upstream end (22), and an outer contour (23), said device comprising: - a holder (30) having a downstream end (31) and an opposite upstream end (32) and an inner contour (33), in which, in an assembled state, a fluid component is placed inside the holder, the downstream end (21) of the fluid component (20) being supported by the downstream end (31) of the holder; - an elastomeric molding (40) having a downstream end (41) and an opposite upstream end (42) and an inner contour (43) and an outer contour (44), the inner contour (43) of the elastomeric molding (40) surrounding and contacting the outer contour (23) of the fluid component; - a fitting (50) adapted to be fixed to the upstream end (32) of the holder (30), the fitting (50) having a downstream end (51) and an opposite upstream end (52) and an outer contour (53), the outer contour (52) of the fitting being adapted to the inner contour (33) of the holder, the fitting (50) comprising at least one protrusion (55) that projects into the holder and contacts and deforms the elastomeric molding; Including, The elastomeric molding comprises at least one compensation surface (45), which in the assembled state does not come into contact with the mating part or the at least one projection of the mating part.

[0081] 2. The apparatus according to item 1, wherein the compensation surface is located at the downstream end of the elastomer molding or inside the elastomer molding.

[0082] 3. The apparatus of claim 1 or 2, wherein the compensation surface is not located at the upstream end of the elastomeric molding.

[0083] 4. The device according to any one of items 1 to 3, wherein the compensation surface is formed by at least a portion of the downstream surface of the elastomeric molding being inclined or sloped (with respect to a plane perpendicular to the main axis of the device) towards the inner and / or outer contour of the elastomeric molding.

[0084] 5. The device according to any one of items 1 to 4, wherein the compensation surface is formed by at least a portion of the downstream (low pressure) surface of the elastomeric molding being inclined or sloped (with respect to a plane perpendicular to the main axis of the device) towards the inner contour of the elastomeric molding.

[0085] 6. The device according to any one of items 1 to 5, wherein the compensation surface (45) is formed by at least one hollow space arranged inside the elastomeric molding (40).

[0086] 7. The device according to item 6, wherein the compensation surface (45) is formed by a hollow space arranged inside the elastomeric molding (40).

[0087] 8. The device according to any one of items 1 to 7, wherein at least one protrusion (55) of the fitting portion (50) has the form of at least one annular ring.

[0088] 9. The device according to any one of items 1 to 8, wherein at least one protrusion (55) of the fitting portion (50) is in the form of multiple protrusions.

[0089] 10. The device according to item 9, wherein the plurality of protrusions (55) have equal heights and / or widths.

[0090] 11. The device according to any one of items 1 to 10, wherein at least one protrusion (55) has a total volume Vp, and the compensation volume (56) or the internal compensation volume has a total volume Vc, and the total volume Vp of at least the protrusion (55) is adapted to the total volume Vc of the compensation volume (56) or the internal compensation volume.

[0091] 12. The device according to item 11, wherein the total volume Vp of at least the protrusions (55) is about 10% to about 50% of the total compensation volume Vc.

[0092] 13. The device according to any one of items 1 to 12, wherein the entire surface of the upstream end (42) of the elastomeric molding (40) contacts the downstream surface (51) of the mating portion (50) and / or at least one protrusion (55).

[0093] 14. The device according to any one of items 1 to 13, wherein the fluid component (20) is a nozzle for atomizing or aerosolizing a liquid.

[0094] 15. The device according to any one of items 1 to 14, wherein the fluid component (20) is a nozzle for nebulized aerosolization of a medically active liquid to be administered by inhalation to a subject in need thereof.

[0095] 16. The device according to any one of items 1 to 15, wherein the fluid component (20) is an impingement nozzle.

[0096] 17. The device according to any one of items 1 to 16, wherein the fluid component (20) has a cylindrical or rectangular shape.

[0097] 18. The device according to any one of items 1 to 17, adapted to clamp a plurality of fluidic components (20), preferably two fluidic components (20).

[0098] 19. The apparatus of any one of items 1 to 18, wherein the elastomeric molding (40) comprises or consists essentially of synthetic rubber, a fluoropolymer material, nitrile butadiene rubber (NBR), ethylene propylene diene monomer rubber (EPDM), polytetrafluoroethylene (PTFE), silicone, or liquid silicone rubber (LSR).

[0099] 20. The device according to any one of items 1 to 19, wherein the holder (30) and / or the fitting (50) and / or the at least one protrusion (55) comprises or consists essentially of stainless steel, polyethylene, polystyrene, polyetheretherketone (PEEK), acrylonitrile butadiene styrene (ABS), polycarbonate and polyamide.

[0100] 21. An inhalation device (60) for administering medically active liquids by inhalation in aerosol form, comprising a device according to any one of items 1 to 20.

[0101] 22. A method for clamping a fluid component, comprising: a) A device for clamping a fluid component (20) according to any one of items 1 to 20, - holder (30), - an elastomeric molding (40) having at least one compensation surface (45), - fluid components (20), in particular nozzles such as impingement nozzles, and - a fitting (50) comprising at least one projection (55) providing a part of the apparatus comprising: -b) assembling the device, b1) introducing the elastomeric molding (40) into the holder (30) and subsequently the fluidic component (20) into the holder (30); or b2) introducing the fluid component (20) into the elastomer molding (40), and then introducing the elastomer molding (40) holding the fluid component (20) into the holder (30); and assembling the c) compressing the elastomeric molding (40) by fixing the fitting (50) to the holder (30) and thereby bringing at least one protrusion (55) of the fitting (50) into contact with the upstream surface of the elastomeric molding (40); A method comprising:

[0102] Detailed Description of the Drawings FIG. 1 shows a cross-sectional view of an apparatus 10 for clamping a fluid component 20 with an elastomeric molding 40 having a compensating surface 45 facing the fluid component 20 before final assembly. In the embodiment shown in FIG. 1a and the following figures, the fluid component has the form of a nozzle, more specifically, an impingement nozzle having at least two ejection channels 24 (two ejection channels are shown) and a downstream end 21, an opposite upstream end 22, and an outer contour or surface 23. As already described in detail above, the apparatus 10 enables gas-tight and liquid-tight clamping and fixation of a fluid component, such as a nozzle 20, even under fluctuating fluid pressures. In FIG. 1, the apparatus of the present invention is shown before final assembly, and thus the fluid component is not (yet) gas-tight and liquid-tight clamped and fixed.

[0103] The apparatus 10 further comprises a holder 30 having a downstream end 31 and an opposite upstream end 32, and an inner contour or surface 33 corresponding to the inner surface of a sidewall 35 of the holder 30. The holder further comprises an outlet opening 34 through which a liquid or fluid may be delivered, particularly if the liquid or fluid is to be sprayed by a nozzle as a fluid component. Opposite the outlet opening 34, the holder 30 as shown in FIG. 1 has an access opening 36 located at the upstream end 32 of the holder 30, through which further components of the apparatus 10, such as the fluid component 20 and the elastomeric molding 40 described below, may be introduced into the holder 30.

[0104] As shown in FIG. 1, the fluid part 20 is disposed inside the holder 30 , and the downstream end 21 of the fluid part 20 is supported by the downstream end 31 of the holder 30 .

[0105] The apparatus 10 of the present invention further comprises an elastomeric molding 40 having a downstream end 41 and an opposite upstream end 42, as well as an inner contour 43 and an outer contour 44. As can be seen in FIG. 1 , the inner contour 43 of the elastomeric molding 40 surrounds and contacts the outer contour 23 of the fluid component 20. However, it should be noted that in the embodiment shown in FIG. 1 , the inner contour 43 of the elastomeric molding does not contact the entire outer contour 23 of the fluid component 20. Since FIG. 1 presents a cross-sectional view of the apparatus 10, which may have, for example, a generally cubic or circular shape as already described above, the elastomeric molding 40, although shown in FIG. 1 and the following figures as two separate mirror-symmetrical units, could instead belong to a single elastomeric molding 40, for example, in the form of a ring.

[0106] The apparatus 10 further includes a mating portion 50 adapted to be secured to the upstream end 32 of the holder 30. As shown in the embodiment of FIG. 1, the mating portion may be secured to an inner surface of the upstream end 32 of the holder 30. However, in other embodiments, the mating portion may also be adapted to be secured to other areas of the holder, such as the upstream face of the upstream end 32 of the holder 30. As noted above, FIG. 1 illustrates a cross-sectional view of the clamping apparatus 10, which may have, for example, a generally cubic or circular shape. Thus, the retaining element 50 shown in FIG. 1 and in the following figures as two separate parts may actually belong to the same holder 30, which has a generally flat circular shape around the central, primary rotation axis X of the apparatus 10 (see FIG. 2) and surrounds a fluid opening 54 through which fluid or liquid to be delivered to the fluid-use component can enter the clamping apparatus.

[0107] The mating portion 50 also has a downstream end or surface 51, an opposite upstream end or surface 52, and an outer contour 53. As shown in Figure 1, the outer contour 52 of the mating portion 50 is adapted to the inner contour 33 of the holder, so that the mating portion can be secured to the holder, particularly in a position where at least one projection 55 of the mating portion contacts and compresses the elastomeric molding in the final assembled state of the clamping device, as will be described below.

[0108] As described above, the fitting 50 includes at least one protrusion 55 disposed on or attached to the downstream surface 51 of the fitting 50 such that the at least one protrusion 55 protrudes into the (inner cavity) of the holder 30 and contacts and deforms the elastomeric molding 40 in its final and fully assembled position. In the embodiment shown in FIG. 1 , the at least one protrusion 55 is already in contact with the elastomeric molding 40, but has not yet deformed the elastomeric molding 40 because the fitting 50 is not in its final and fully assembled position and is fixed to the upstream end of the holder 30. As described above in connection with the fitting 50, the protrusions 55 shown in FIG. 1 may be part of the same protrusion, for example, a circular ring-like structure, or may be two separate protrusions, for example, two protrusions in the form of knobs or bars, located at opposite (lateral) ends of the fitting 50.

[0109] The elastomeric molding 50 of the device 10 of the present invention further includes at least one compensating surface 45. As shown in FIG. 1, the at least one compensating surface 45 does not contact the mating portion 50 and / or the at least one protrusion 55 of the mating portion 50. In this regard, however, it should also be noted that FIG. 1 does not show the device 10 in its final assembled state, in which the mating portion 50 is secured to the holder 30 and the fluid component 20 is firmly clamped by the device 10. In the device shown in FIG. 1, the fluid component 20 and the elastomeric molding 40 have already been introduced into the lumen of the holder 30, but the mating portion 50 and the protrusion 55 are not yet in their final positions.

[0110] As seen in the embodiment shown in FIG. 1 , the compensating surface(s) 45 of the elastomeric molding 40 is located at the downstream end 41 of the elastomeric molding 40. Specifically, the compensating surface(s) 45 of the elastomeric molding 40 is not located at the upstream end 42 of the elastomeric molding 40. Furthermore, in the embodiment shown in FIG. 1 , the compensating surface 45 is formed by at least a portion of the downstream surface 41 of the elastomeric molding 40 being inclined or sloped (with respect to a plane perpendicular to the major axis X (see FIG. 2 ) of the apparatus) toward the inner contour 43 of the elastomeric molding 40. In this configuration, the compensating surface 45 of the elastomeric molding 40, together with the outer contour 23 of the fluid component 20 and the inner surface of the downstream end 31 of the holder 30, define and limit a compensation volume 56 into which the elastomeric molding 40 can expand when compressed by the fitting 50 and / or at least one protrusion 55 of the fitting 50.

[0111] FIG. 2 shows the device 10 shown in FIG. 1 in a final assembled state, with the mating portion 50 secured to the holder 30, although some of the elements and components described in FIG. 1 have been omitted for clarity. Thus, FIG. 2 (like FIGS. 4 and 6) also illustrates an embodiment of the fluid assembly 15 of the present invention. As can be seen, at least one protrusion 55 and the mating portion 50 itself contact the upstream end of the elastomeric molding 40. This causes the at least one protrusion 55 to reach and deform the elastomeric molding 40. Due to the distribution of pressure exerted by the protrusion 55, which deforms the elastomeric molding 40 at its upstream end or surface 42, the elastomeric molding is deformed on the opposite side by expanding and extending the compensation surface 45 of the elastomeric molding 40 into the compensation volume 56, resulting in a decrease in the compensation volume (Vc). However, this results in an even distribution of pressure throughout the elastomer molding 40, specifically throughout the inner contour 43 of the elastomer molding 40 that contacts the outer contour 23 of the fluid component 20, thereby effectively clamping the fluid component 20 liquid-tight and airtight without the risk of damaging the clamped fluid component 20.

[0112] FIG. 3 shows another embodiment of the device 10 for clamping a fluid component 20 with an elastomeric molding 40 having a compensation surface 45 facing the inner contour 33 of the holder 30 before assembly. As in FIG. 2, the parts of the device correspond to those described in FIG. 1, with some reference numerals omitted to avoid redundancy. As mentioned above, according to this embodiment, the compensation surface 45 is also not in contact with the mating part 50 and / or its at least one protrusion 55 in the assembled state, but is located at the downstream end 41 of the elastomeric molding 40. However, in contrast to the embodiment shown in FIGS. 1 and 2, the compensation surface 45 of the elastomeric molding 40 is formed by at least a portion of the downstream surface 41 of the elastomeric molding 40 being inclined or tilted (with respect to a plane perpendicular to the main axis X of the device) toward the outer contour 44 of the elastomeric molding 40. In this configuration, the compensation surface 45 of the elastomeric molding 40, together with the inner surface 33 of the downstream end 31 of the holder 30, define and limit a compensation volume 56 into which the elastomeric molding 40 can expand when compressed by the mating portion 50 and / or at least one protrusion 55 of the mating portion 50. In this embodiment, contact between the inner contours 43 of the elastomeric molding 40 is maximized from the outset, as the inner contours 43 of the elastomeric molding fully contact and surround the outer contour 23 of the fluid component 20.

[0113] 4 shows the embodiment of the device 10, and thus the fluid assembly 15, of FIG. 3 in a final assembled state in which the mating portion 50 is secured to the holder 30, although some of the elements and components described in FIG. 1 have been omitted for clarity. Just as in the embodiment shown in FIG. 2, the at least one protrusion 55 and the mating portion 50 itself contact the upstream end of the elastomeric molding 40. This causes the at least one protrusion 55 to reach and deform the elastomeric molding 40, or more specifically, the compensation surface 45 of the elastomeric molding 40. Due to the distribution of pressure exerted by the protrusion 55, which deforms the elastomeric molding 40 at its upstream end or surface 42, the elastomeric molding is deformed on the opposite side by the expansion and extension of the compensation surface 45 of the elastomeric molding 40 into the compensation volume 56, resulting in a reduction in the compensation volume (Vc).

[0114] Figure 5 shows a further embodiment of an apparatus 10 for clamping a fluid component on an elastomeric molding 40 having an internal compensation surface 45 in the form of a hollow space or internal compensation volume 57 located inside the elastomeric molding 40 before final assembly. As in the embodiment shown in Figure 3, parts of the apparatus (10) correspond to the components described in Figure 1, with some reference numbers omitted to avoid redundancy.

[0115] As mentioned above, according to this embodiment, the compensating surface 45 is also not in contact with the mating part 50 and / or its at least one protrusion 55 in the assembled state, but is located inside the elastomeric molding. However, in contrast to the embodiment shown in Figures 1 to 4, the compensating surface 45 of the elastomeric molding 40 is formed by at least one hollow space located inside the elastomeric molding and therefore not in contact with the ambient atmosphere.

[0116] In this embodiment, too, contact between the inner contours 43 of the elastomeric moldings 40 is maximized from the start, as the inner contours 43 of the elastomeric moldings fully contact and surround the outer contour 23 of the fluid component 20. Furthermore, contact between all outer surfaces of the elastomeric moldings 40 and the holder 30, the mating portion 50 and its at least one protrusion 55, as well as the surrounding surfaces of the fluid component 20 is maximized, resulting in effective clamping and fixation of the fluid component 20 in the final assembled state. In this embodiment, the internal compensation surface 45 surrounding the internal compensation volume 57 is formed by a hollow annular space located inside the elastomeric molding.

[0117] 6 shows a further embodiment of the device 10, and thus the fluid assembly 15, of FIG. 5 in a final assembled state in which the mating portion 50 is secured to the holder 30, although some of the elements and parts described in FIG. 1 have been omitted for clarity. Just as in the embodiment shown in FIGS. 2 and 4, at least one protrusion 55, as well as the mating portion 50 itself, contacts the upstream end 42 of the elastomeric molding 40. This causes the at least one protrusion 55 to reach and deform the elastomeric molding 40. Due to the distribution of pressure exerted by the protrusion 55, which deforms the elastomeric molding 40 at its upstream end or surface 42, the elastomeric molding is deformed on the opposite side by the expansion of the internal compensation surface 45 of the elastomeric molding 40 into the internal compensation volume 57, resulting in a reduction in the internal compensation volume (Vc).

[0118] In all embodiments shown in Figures 1 to 6, the compensation volume 56 or internal compensation volume 57 is (slightly) larger than the total volume Vp of the at least one protrusion 55, resulting in a remaining smaller compensation volume 56 or internal compensation volume 57 after complete and final assembly of the device by fixing the fitting 50 to the holder 30.

[0119] Figure 7 shows a perspective view of one embodiment of a fitting 50 having a continuous circular protrusion 55. The fitting 50 shown in Figure 7 has a downstream face 51, an exterior contour or surface 53, and a fluid opening 54 that allows the passage of a fluid or liquid to be delivered to a fluid-containing component clamped by the clamping apparatus of the present invention. The downstream face 51 of the fitting 50 is provided with an annular protrusion 55 that is centered about the primary axis of rotation X of the clamping apparatus.

[0120] Figure 8 shows a perspective view of an alternative embodiment of the mating portion 50. In this embodiment, the continuous circular projection 55 shown in the embodiment of Figure 7 is replaced with multiple projections 55 arranged in the form of discontinuous circular rings as in Figure 7, centered about the primary axis of rotation X (see Figure 7). As can be seen in Figure 8, all of the multiple projections 55 have equal height and width.

[0121] FIG. 9 shows a schematic cross-sectional view of an exemplary inhalation device 60 for inhalation administration of a medically active liquid in aerosol form, including a clamping device 10 and, more specifically, a fluid assembly 15 including such a clamping device. The inhalation device 60 includes a housing 61, preferably shaped and sized so that it can be held in one hand and manipulated with one finger, e.g., a thumb (not shown). A reservoir 62 for storing the medically active liquid is disposed inside the housing 61. The illustrated reservoir 62 is designed to be collapsible. This means that the elastic or at least calcareous walls buckle during emptying, resulting in little or no increase in the negative pressure required to extract a given amount of liquid. Furthermore, the inhalation device 60 includes a pump unit 63 within the housing 61, including a piston 63A and a pump chamber 63B, for generating the desired pressure required to expel and nebulize the medically active liquid. The pump chamber 63B is fluidly connected to the reservoir 62 by an inlet check valve 64. Check valve 64 functions to allow the inflow of medically active fluid into pump chamber 63B and prevents backflow of fluid into reservoir 62 upon release of a locking mechanism, not shown. A spring 65 is provided as a means for storing and delivering potential energy, coupled to one end (facing upward) of pump unit 63 and supported by housing 61 (bottom of illustration).

[0122] The clamping device 10 or fluid assembly 15 including the fluid component, or more specifically the nozzle 20, is placed on the upper edge of the housing 61 of the suction device 60 so that the nozzle 20 is in fluid connection with the pump unit. In the illustrated embodiment, the fitting is formed by the outer surface of the housing 61. However, in further embodiments, it is also possible to design the fitting 50 as a separate element and to attach such a fitting 50 or fluid assembly 15 to the suction device 60, as shown above in Figures 1 to 8. [Explanation of symbols]

[0123] 10 Clamping device 15 Fluid Assembly 20 Fluid parts, nozzles 21 downstream end of fluid component 22 Upstream end of fluid component 23 Outer contour of fluid components 24 Fluid component drain channel 30 Holder 31 downstream end of holder 32 upstream end of holder 33 Inner contour of holder 34 Holder outlet opening 35 Holder side wall 36 Access opening of holder 40 Elastomer molding part 41 Downstream end of elastomer molding part 42 Upstream end of elastomer molding part 43 Inner contour of elastomer molding 44 Outer contour of elastomer molding 45 Compensation surface of elastomer molding 50 Fitting part 51 Downstream surface of fitting 52 Upstream face of fitting 53 Outer contour of mating part 54 Fluid opening of mating part 55 Protrusion of mating part 56 Compensation volume 57 Internal compensation volume X - the main axis of rotation of the device 60 Inhaler 61 Housing 62 Reservoir filled with drug solution 63 Pump Unit 63A Piston 63B Pump Room 64 valves 65 Spring

Claims

1. 1. An apparatus (10) for clamping a fluid component (20) subjected to fluctuating fluid pressure, said fluid component (20) having a downstream end (21), an opposite upstream end (22) and an outer contour (23), said apparatus comprising: a holder (30) having a downstream end (31) and an opposite upstream end (32) and an inner contour (33), in which, in an assembled state, the fluid component is placed inside the holder and the downstream end (21) of the fluid component (20) is supported by the downstream end (31) of the holder; an elastomeric molding (40) having a downstream end (41) and an opposite upstream end (42) and an inner contour (43) and an outer contour (44), said inner contour (43) of said elastomeric molding (40) surrounding and contacting said outer contour (23) of said fluid component; a fitting (50) adapted to be fixed to the upstream end (32) of the holder (30), the fitting (50) having a downstream end (51) and an opposite upstream end (52) and an outer contour (53), the outer contour (52) of the fitting being adapted to the inner contour (33) of the holder, the fitting comprising at least one protrusion (55) which projects into the holder and which deforms in contact with the elastomeric moulding; Equipped with The elastomer molding comprises at least one compensation surface (45) which, before being in an assembled state, defines a hollow space between the compensation surface (45) and at least the holder (30) at the downstream end (41) of the elastomer molding (40) or defines an internal compensation volume (57) which expands when the elastomer molding (40) is in an assembled state, and the at least one compensation surface (45) in the assembled state does not contact the fitting portion or the at least one protrusion of the fitting portion.

2. 2. The device according to claim 1, wherein the compensation surface (45) is located inside the elastomeric molding (40).

3. 3. The device of claim 1 or 2, wherein the compensation surface is a surface or surface area of ​​the elastomeric molding configured to deform upon contact with the mating portion or the at least one protrusion of the mating portion.

4. The device according to any one of claims 1 to 3, wherein the compensation surface is not located at the upstream end of the elastomeric moulding.

5. 5. The device according to claim 1, wherein the compensation surface (45) is formed from at least a portion of the surface of the downstream end of the elastomeric molding (40) and is inclined or sloped towards the inner contour (43) and / or the outer contour (44) of the elastomeric molding (40).

6. 6. The device according to claim 1, wherein the compensation surface (45) is formed from at least a portion of the surface of the downstream end of the elastomeric molding (40) and is inclined or sloped towards the inner contour (43) of the elastomeric molding (40).

7. 7. Device according to any one of the preceding claims, wherein the compensation surface (45) is formed by at least one hollow space arranged inside the elastomeric moulding (40).

8. 8. The device according to claim 7, wherein the compensation surface (45) is formed by a hollow space arranged inside the elastomeric molding (40).

9. 9. The device according to any one of the preceding claims, wherein the at least one protrusion (55) of the fitting (50) has the form of at least one annular ring.

10. 10. The device according to any one of claims 1 to 9, wherein the at least one protrusion (55) of the fitting (50) is in the form of a plurality of protrusions.

11. 11. The device of claim 10, wherein the plurality of protrusions (55) have equal heights and / or widths.

12. 12. The device according to claim 1, wherein the at least one protrusion (55) has a total volume Vp and the hollow space defines a compensation volume (56) or the internal compensation volume having a total volume Vc, and the total volume Vp of the at least one protrusion (55) is adapted to the total volume Vc of the compensation volume (56) or the internal compensation volume.

13. 13. The device according to claim 12, wherein the total volume Vp of the at least one protrusion (55) amounts to about 10% to about 50% of the total volume Vc of the compensation volume (56) or the internal compensation volume.

14. 14. The device according to claim 1, wherein the entire surface of the upstream end (42) of the elastomeric molding (40) contacts the downstream surface (51) of the fitting portion (50) and / or the at least one protrusion (55).

15. 15. The device according to any one of claims 1 to 14, wherein the fluid component (20) is a nozzle for atomizing or aerosolizing a liquid.

16. 16. The device according to any one of claims 1 to 15, wherein the fluid component (20) is a nozzle for nebulization or aerosolization of a medically active liquid to be administered by inhalation to a subject in need thereof.

17. 17. The device of any one of claims 1 to 16, wherein the fluid component (20) is an impingement nozzle.

18. 18. The device according to any one of claims 1 to 17, wherein the fluid component (20) has a cylindrical or rectangular shape.

19. 19. The device according to any one of the preceding claims, adapted to clamp a plurality of fluid components (20).

20. 20. The apparatus of any one of claims 1 to 19, wherein the elastomeric molding (40) comprises or consists essentially of synthetic rubber, a fluoropolymer material, nitrile butadiene rubber (NBR), ethylene propylene diene monomer rubber (EPDM), polytetrafluoroethylene (PTFE), silicone, or liquid silicone rubber (LSR).

21. 21. The device according to any one of claims 1 to 20, wherein the holder (30) and / or the fitting (50) and / or the at least one protrusion (55) comprise or consist essentially of stainless steel, polyethylene, polystyrene, polyetheretherketone (PEEK), acrylonitrile butadiene styrene (ABS), polycarbonate and polyamide.

22. A fluid assembly comprising a device for clamping a fluid component according to any one of claims 1 to 21 and a fluid component clamped by said device.

23. 23. The fluid assembly of claim 22, wherein the device for clamping the fluid component is a nozzle holder and the fluid component is a nozzle.

24. An inhalation device (60) for administering by inhalation a medically active liquid in aerosol form, comprising a device (10) according to any one of claims 1 to 21 or a fluid assembly according to claim 22 or 23.

25. 24. A method for clamping a fluidic component or for manufacturing a fluidic assembly according to claim 22 or 23, comprising the steps of: a) a device (10) for clamping a fluid component (20) according to any one of claims 1 to 21, - holder (30), an elastomer molding (40) having at least one compensation surface (45); - a fluid component (20), and a fitting (50) comprising at least one projection (55); Providing a component of the device (10) comprising: b) assembling the device, b1) introducing the elastomeric molding (40) into the holder (30) and subsequently introducing the fluid component (20) into the elastomeric molding (40); or b2) introducing the fluid component (20) into the elastomer molding (40), and subsequently introducing the elastomer molding (40) holding the fluid component (20) into the holder (30). and assembling the c) fixing said fitting (50) to said holder (30), thereby compressing said elastomeric molding (40) by bringing said at least one projection (55) of said fitting into contact with the surface of said upstream end of said elastomeric molding (40); A method comprising:

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