Microstructure nozzle

Abstract

The invention provides a microstructured nozzle (1) for a device (100) for generating an inhalable aerosol of a medically active fluid (2), the microstructured nozzle having a main filter (21), an inlet (3) for unfiltered fluid and an outlet (4) for filtered fluid, the inlet and outlet defining a flow direction (X) of the fluid from the inlet to the outlet, the nozzle comprises a substantially flat base plate (5) and a cover plate (6) attachable thereto; a main filter zone (20) comprising a main filter (21); a filtrate outlet zone (30) arranged between the main filter and the outlet in the flow direction; and a fluid distribution zone (40) arranged in the flow direction between the inlet and the main filter zone wherein a second stage structure (41) is arranged in the fluid distribution zone, which second stage structure comprises a plurality of cylindrical built-in elements (42) extending transversely to the flow direction from the base plate and / or the cover plate. The invention also provides an inhalation device (100) for inhalation therapy comprising such a microstructured nozzle.

Description

Field of the Invention

[0001] The present invention relates to the field of inhalation devices for medicinally active fluids. In particular, the present invention relates to a microstructured nozzle of a device for generating an inhalable aerosol of a medicinally active fluid, and to an inhalation device comprising such a microstructured nozzle. Background Art

[0002] Atomizers or other aerosol generators for liquids have long been known in the art. Among other things, such devices are also used in medical science and therapy. There, they serve as inhalation devices for the application of active ingredients in the form of an inhalable aerosol, i.e., small liquid droplets embedded in a gas. Such inhalation devices are known, for example, from the document EP 0 627230B1. The main components of such an inhalation device include: a reservoir containing the liquid to be aerosolized; a pumping device for generating a high enough pressure to atomize the liquid; and a spraying device in the form of a nozzle. By means of the pumping device, the liquid is withdrawn from the reservoir in discrete amounts (i.e., discontinuously) and fed to the nozzle. The pumping device operates without a propellant and mechanically generates pressure.

[0003] To obtain a sufficiently homogeneous and fine droplet mist, relatively high pressures are usually required, such as from 10 bar to about 300 bar, or even higher. To keep the amount of vaporized liquid per dose at an acceptably low level, the atomizing nozzle usually includes one or several channels, each channel having a cross-section of only a few μm 2 (square micrometers) in magnitude, for example from 2 μm 2 to 200 μm 2 . The channel is present in the nozzle body and is usually produced using microtechnology manufacturing techniques, such as microetching, microlithography, etc.

[0004] US2005 / 0001076 A1 discloses a specific example of a nozzle used in a specific atomizer. The disclosed microstructured nozzle consists of several channels, which are produced by microstructuring a plate-like member. In the nozzle, the channels are located between projections that are arranged side by side and protrude from a bottom plate. The microstructured bottom plate is covered with a cover plate. The channels are narrowly defined in terms of shape, cross-sectional area, and length. The disclosed nozzle includes a zigzag filter as a primary structure and a secondary structure downstream of the filter.

[0005] Due to the plate-like layout of the disclosed microstructured nozzle, the microstructured nozzle has an inlet groove for the pressurized liquid to enter. It has proven difficult to uniformly provide the flow of pressurized liquid to be sprayed across the entire width of the inlet groove, especially considering the fact that the pressurized liquid to be sprayed is typically provided by a circular pipe or other device connected to a pump or pressure generator. This results in non-uniform distribution of the pressurized liquid within the nozzle, which particularly affects the contact of the fluid with the filter element, which can be in a zigzag or other form.

[0006] Accordingly, an object of the present invention is to provide an improved microstructured nozzle that can provide a more uniform distribution of the pressurized fluid to be sprayed within the nozzle structure, especially with respect to the filter structure provided in such a microstructured nozzle. Further objects of the present invention will become apparent from the following description, examples and claims of the present invention. Summary of the Invention

[0007] In a first aspect, the present invention relates to a microstructured nozzle (1) of an apparatus (100) for generating an inhalable aerosol of a pharmaceutically active fluid (2), the microstructured nozzle having a main filter (21), an inlet (3) for the unfiltered fluid and an outlet (4) for the filtered fluid, the inlet and the outlet defining a flow direction (X) of the fluid from the inlet to the outlet, the nozzle comprising: - a substantially flat bottom plate (5) and a cover plate (6) attachable thereto; - a main filter region (20) including a main filter (21) configured as a primary structure, having a plurality of main filter protrusions (22) arranged side by side in at least one row (23), each main filter protrusion being formed as an integral part of the bottom plate and protruding from the bottom plate, the main filter protrusions being spaced from each other by main filter channels (24), the main filter channels forming a path for the fluid to pass through the nozzle from the inlet to the outlet, and the cover plate, if attached to the bottom plate, covering the main filter protrusions and the main filter channels; - a filtrate outlet region (30) arranged between the main filter and the outlet in the flow direction; and - a fluid distribution region (40) arranged between the inlet and the main filter region in the flow direction, wherein a secondary structure (41) is provided in the fluid distribution region, the secondary structure including a plurality of cylindrical built-in elements (42) extending transversely to the flow direction from the bottom plate and / or the cover plate.

[0008] In a second aspect, the present invention provides an inhalation device for inhalation therapy, which includes the microstructured nozzle according to the first aspect of the present invention. Brief Description of the Drawings

[0009] Figure 1Describes a cross-sectional view of an exemplary inhalation device (100) including a microfluidic nozzle (1);

[0010] Figure 2 Describes an embodiment of the bottom plate (5) of the present microfluidic nozzle (1), as viewed from the initially open side, which can subsequently be covered with a cover plate (6) (not shown);

[0011] Figure 3 Shows an enlarged top view of a part of a cylindrical built-in element (42) of a secondary structure provided in a section of the fluid distribution area (40);

[0012] Figure 4 Shows an enlarged top view of a section of the main filter (21);

[0013] Figure 5A and 5B Shows a perspective view of the microstructured nozzle (1) according to the present invention, including a bottom plate (5) and a cover plate (6) attached to each other; and

[0014] Figure 6 Shows as Figure 2 A perspective view of a section of the bottom plate (5) of the microstructured nozzle (1) shown in the top view in. Detailed Description

[0015] Unless otherwise defined in the description or otherwise specified or required by the specific context, the following terms or expressions used in this section shall generally be interpreted as described in this section:

[0016] In this specification and the claims, the terms "comprise", "comprises", "comprising" and similar expressions shall be understood as "including but not limited to", being open and inclusive. In contrast, the terms "consist of", "consists of" and "consisting of" used herein are so-called closed-language terms, meaning that only the components mentioned exist.

[0017] The term "a" or "an" does not exclude the plural; that is, the singular forms "a", "an" and "the" shall be understood to include plural referents, unless the context clearly indicates or otherwise requires. In other words, unless otherwise clearly specified or there is an obvious contrary implication in the context of the reference, all singular features or limitations mentioned in this disclosure shall include the corresponding plural features or limitations, and vice versa. Therefore, the terms "a", "an" and "the" have the same meaning as "at least one" or "one or more", unless otherwise defined.

[0018] Expressions such as "one embodiment", "an embodiment", "a specific embodiment", etc. mean that in at least one embodiment of the present invention, there are specific features, properties or characteristics, or groups or combinations of specific features, properties or characteristics, which are mentioned in combination with the corresponding expressions. These expressions appearing throughout this specification do not necessarily refer to the same embodiment. In addition, in one or more embodiments, specific features, properties or characteristics can be combined in any suitable manner.

[0019] Terms such as "essentially", "about", "approximately", "substantially", etc., when associated with an attribute or a numerical value, include the exact attribute or precise numerical value, as well as any attribute or numerical value that is generally considered to be within the normal range or variability range acceptable in the relevant technical field. For example, the term "about" used herein in relation to a numerical value or a numerical range means that the numerical value or numerical range includes typical deviations from that numerical value, with a maximum deviation of + / - 5% (abs., absolute value), or a maximum of + / - 4%, or a maximum of + / - 3%, or a maximum of + / - 2%, or a maximum of + / - 1%, or a maximum of + / - 0.5%.

[0020] According to a first aspect, the present invention provides a microstructured nozzle (1) for an apparatus (100) for generating an inhalable aerosol (or aerosol) of a pharmaceutically active fluid (2), the microstructured nozzle having a main filter (21), an inlet (3) for unfiltered fluid, and an outlet (4) for filtered fluid, the inlet and the outlet defining a flow direction (X) of the fluid from the inlet to the outlet, the nozzle comprising: - a substantially flat bottom plate (5) and a cover plate (6) attachable thereto; - a main filter region (20) including a main filter (21) configured as a primary structure, having a plurality of main filter protrusions (22) arranged side by side in at least one row (23), each main filter protrusion being formed as an integral part of the bottom plate and protruding from the bottom plate, the main filter protrusions being spaced from each other by main filter channels (24), the main filter channels forming a path for the fluid to pass through the nozzle from the inlet to the outlet, and the cover plate, if attached to the bottom plate, covering the main filter protrusions and the main filter channels; - a filtrate outlet region (30) arranged in the flow direction between the main filter and the outlet; and - a fluid distribution region (40) arranged in the flow direction between the inlet and the main filter (for the distribution of unfiltered fluid before contact with the main filter), wherein in the fluid distribution region there is provided a secondary structure (41) which includes a plurality of cylindrical built-in elements (42) extending transversely to the flow direction from the bottom plate and / or the cover plate.

[0021] The present invention provides a microstructured nozzle for a device for generating an inhalable aerosol of a medicinally active fluid. Inhalation devices for generating an inhalable aerosol of a medicinally active fluid, or in other words, nebulizers, have been described in the prior art, such as, for example, US 2005 / 0001076 A1 discussed above and the references cited therein. Another inhalation device is disclosed in WO 2018 / 197730 A1, the content of which is incorporated herein by reference in its entirety. These inhalation devices typically have a small size so that they can be held and operated by a user with one hand. They generally include a reservoir for containing the medicinally active fluid to be aerosolized and administered, a pumping unit for pressurizing the medicinally active fluid, a drive mechanism, and a nozzle unit through which the medicinally active fluid pressurized by the pumping unit is aerosolized, or in other words, sprayed. According to the present invention, such a nozzle unit may include a microstructured nozzle described in more detail below.

[0022] The microstructured nozzle according to the present invention is adapted to generate an inhalable aerosol of a medicinally active fluid, where the term "medicinally active fluid" as used herein refers to a pharmaceutically acceptable liquid compound or composition, in particular a liquid compound or composition having a pharmacological activity or comprising a compound or composition having a pharmacological activity, which compound or composition is capable of improving or preventing symptoms associated with a disease, disorder or condition, in particular a disease, disorder or condition of the respiratory system, such as a disease, disorder or condition of the lungs of a subject, in particular a warm-blooded animal or a human, especially a human. Specific examples of such diseases, disorders or conditions include, but are not limited to, lung diseases or conditions such as asthma and / or chronic obstructive pulmonary disease (COPD), especially COPD, or interstitial lung diseases affecting the lung interstitium and lung tissue, such as lung diseases associated with the airways and / or air sacs (alveoli), such as pulmonary fibrosis, such as idiopathic pulmonary fibrosis (IPF), interstitial pneumonia or sarcoidosis.

[0023] Furthermore, the term "inhalable aerosol" refers to an aerosol having respirable particles or droplets, the mass median aerodynamic diameter (measured by laser diffraction) of which preferably does not exceed about 10 μm, in particular does not exceed about 7 μm or does not exceed about 5 μm, respectively.

[0024] In a specific embodiment, the term "medically active fluid" as used herein refers to a medically active fluid or liquid in the form of a pharmaceutical composition that comprises at least one active pharmaceutical ingredient (API), and more specifically, at least one inhalable active pharmaceutical ingredient. More specifically, such at least one inhalable active pharmaceutical ingredient may be selected from, for example, long-acting muscarinic antagonists (LAMA), long-acting beta agonists (LABA), and inhalable glucocorticosteroids (ICS), as well as from analgesics and antidiabetic drugs, and may be used alone or in combination with each other.

[0025] Examples of long-acting muscarinic antagonists (LAMA) include, but are not limited to: aclidinium bromide, glycopyrronium salts (such as glycopyrronium bromide), revefenaci, tiotropium (such as tiotropium bromide), umeclidinium bromide, oxitropium bromide, flutropium bromide, ipratropium bromide, trospium chloride, tolterodine.

[0026] Examples of long-acting β-agonists (LABA) include, but are not limited to: albuterol, arformoterol, bambuterol, bitolterol, broxaterol, carbuterol, clenbuterol, fenoterol, formoterol, hexoprenaline, ibuterol, indacaterol, indacterol, isoetharine, isoprenaline levosalbutamol, mabuterol meluadrine, metaproterenol, olodaterol, orciprenaline, pirbuterol, procaterol, reproterol, rimiterol, ritodrine, salmeterol, salmefamol, soterenot, sulphonterol, tiaramde, terbutaline, terbuterol.

[0027] Examples of inhaled corticosteroids (ICS) include, but are not limited to: prednisolone, prednisone, butixocort propionate, flunisolide, beclomethasone, triamcinolone, budesonide, fluticasone, mometasone, ciclesonide, rofleponide, dexamethasone, etiprednol-dichloroacetat, deflazacort, etiprednol, loteprednol, RPR-106541, NS-126, ST-26.

[0028] In addition, the active pharmaceutical ingredient can be selected from analgesics, such as opioid analgesics (such as morphine, fentanyl) or non-opioid analgesics (such as salicylic acid derivatives, such as acetylsalicylic acid) or cannabinoids (such as tetrahydrocannabinol) or antidiabetic drugs, such as insulin.

[0029] The medical active fluid that can be atomized or aerosolized through the present microstructured nozzle can include at least one of the above-mentioned active pharmaceutical ingredients, but can also include a mixture of two or more active pharmaceutical ingredients that can be administered by inhalation.

[0030] The medical active fluid described herein can be in the form of a dispersion, such as a suspension having a liquid continuous phase and a solid dispersed phase, or in the form of a solution, especially in the form of an aqueous solution. In addition, the medical active fluid mentioned herein can also include, optionally, one or more physiologically acceptable excipients suitable for inhalation use. The excipients characteristic of the medical active fluid described herein can include, but are not limited to, one or more of buffers, salts, taste-masking agents, surfactants, lipids, antioxidants, preservatives, and solubilizing agents that regulate or control the pH value of the solution. Solubilizing agents can be used to enhance or improve solubility, such as water, alcohols, especially alcohols having 2 to 4 carbon atoms, or preferably 2 or 3 carbon atoms, such as ethanol, propanol, or isopropanol, or ethylene glycol, such as propylene glycol. In a specific embodiment, the above-mentioned medical active fluid can be substantially free or even free of propellants, such as hydrofluoroalkane (HFA) propellants.

[0031] In a specific embodiment, the pharmaceutically active fluid mentioned herein includes at least one of the above-mentioned pharmaceutically active ingredients dissolved in an alcoholic or aqueous liquid carrier or solvent. In a preferred embodiment, such a liquid carrier or solvent includes water and / or ethanol, preferably ethanol. In a further specific embodiment, such a liquid carrier or solvent includes ethanol or a mixture of ethanol and water, or preferably consists of ethanol or a mixture of ethanol and water, wherein the content of ethanol can include, for example, an amount of at least about 50 wt.-%, or at least about 60 wt.-%, or at least about 70 wt.-%, or even more, while the corresponding content of water reaches an amount of about 50 wt.-%, or reaches an amount of about 40 wt.-%, or reaches an amount of about 30 wt.-%, or less. In a specific embodiment, the liquid carrier or solvent includes ethanol or consists of ethanol, with the content of ethanol being about 60 to about 80 wt.-%, such as about 70 wt.-%, and the content of water being about 40 to about 20 wt.-%, such as about 30 wt.-%. In a further specific embodiment, the liquid carrier or solvent can include water or consists essentially of water or consists of water, for example, the content of water ranges from about 80 wt.-%, or 90 wt.-% to about 100 wt.-% (relative to the total weight of the liquid carrier), such as from about 85 wt.-%, or from about 90 wt.-%, or from about 95 wt.-%, or even from about 97 wt.-% to about 98 wt.-%, or to about 99 wt.-%, or to about 99.5 wt.-%, and a further solvent or a mixture of further solvents, preferably an alcohol or ethylene glycol, especially ethanol up to 100 wt.-% of the liquid carrier.

[0032] According to the present invention, the microstructured nozzle has a filter, an inlet for the entry of unfiltered liquid, and an outlet for the delivery and atomization of the filtered liquid. The inlet and outlet of the microstructured nozzle define the flow direction of the fluid from the inlet to the outlet, or in other words, define the direction in which the pharmaceutically active fluid is delivered in the downstream direction.

[0033] The size of the present microstructured nozzle is generally very limited to facilitate use especially in an atomizer or inhalation device, which is portable and suitable for single-handed or two-handed operation by the user. In many cases, the microstructured nozzle according to the present invention has a micro-size with a diameter and / or edge length much less than 10 mm, and even much less than 5 mm as will be further described in detail below. Accordingly, the size of the microstructure provided in the microstructured nozzle as further described in detail below is generally one or more orders of magnitude lower than this.

[0034] According to the present invention, the microstructured nozzle comprises a substantially flat bottom plate and a cover plate attachable to the bottom plate. The bottom plate is preferably structured using etching techniques known to those skilled in the art, for example, AA Ayón et al. 2001 Smart Mater. Struct., 10, 1135. In some embodiments, the bottom plate is generally square or rectangular, with an edge length up to about 5 mm, such as from about 0.5 to about 4 mm, or from about 1 to about 4 mm, or from about 1.5 to about 3 mm, or from about 2 to about 3 mm. In certain embodiments, the bottom plate may have a width (perpendicular to the flow direction) of from about 1.5 mm or from about 2 mm to about 3 mm, such as about 2.5 mm, and a length (along the flow direction) of from about 1.5 mm to about 2.5 mm, such as about 2 mm. The height of the bottom plate generally ranges from about 0.2 mm to about 2 mm, such as from 0.6 mm to about 1.2 mm, or from about 0.9 mm to about 1.8 mm, or from about 1.2 mm to about 1.5 mm. The height of the microstructures (primary structure, secondary structure, and tertiary structure), as described in more detail below, is in some embodiments selected in the range from about 2 μm to about 40 μm, typically from about 3 μm to about 20 μm, preferably from about 4 μm to about 14 μm, particularly from about 5 μm to about 8 μm, or even from about 5 μm to about 7 μm (as measured on the basis of the microstructures on such a bottom plate). In the case where the cover plate does not include any microstructures, or in other words, the cover plate is provided in the form of a flat cover, the height of the above-mentioned microstructures corresponds to the height of the flow channels provided in the microstructured nozzle. Due to the available manufacturing methods, in certain embodiments, the height of all the microstructures provided on the bottom plate (including the primary structure, secondary structure, and tertiary structure described in detail below), as measured from the bottom plate surface in the direction of the cover plate, is the same or substantially the same in some embodiments.

[0035] The material that can be used for the bottom plate is preferably single-crystalline silicon because it is inexpensive and can be obtained in a parallel state with sufficient flatness and slight surface roughness (i.e., in the state of a silicon wafer), and can be attached to the cover plate without the need for additional adhesives or other materials during the subsequent connection process. In order to produce a plurality of nozzles in a parallel manner, a plurality of structured bottom plates can be made from a silicon wafer.

[0036] The microstructured nozzle of the present invention consists of at least two sheets, preferably two sheets, preferably glass and / or silicon, firmly fixed together, wherein at least one sheet has one or more microstructured channels connecting the nozzle inlet to the nozzle outlet. The nozzle with the outlet opening, or in other words, the ejection channel of the microstructured nozzle, is preferably on the opposite side of the nozzle inlet. The nozzle inlet can have only one fluid inlet or a plurality of fluid inlets. After passing through the inlet and an optional coarse filter, the fluid flows through the filtrate distribution area (described in detail below), followed by the main filter formed by a plurality of main filter protrusions. After the main filter, or in other words, when observed in the flow direction (in the "downstream" direction) between the main filter and the outlet of the microstructured nozzle, there is a filtrate collection chamber for collecting the filtered fluid. The fluid flows from the fluid collection chamber to the outlet, which is preferably configured in the form of a nozzle opening and has one or more ejection channels, preferably two ejection channels.

[0037] This microstructured nozzle further includes a cover plate corresponding to the second of the at least two sheets. For example, a suitable cover plate can be a glass sheet, such as an alkali borosilicate glass, such as Pyrex (Corning) or Tempax (Schott). For example, they can be attached to the bottom plate by anodic bonding of silicon and glass.

[0038] In some embodiments, the inlet of the microstructured nozzle of the present invention can be located at the inlet end of the bottom plate, and the outlet can be located at the opposite outlet end of the bottom plate, wherein the inlet and the outlet are connected by opposite side walls, and wherein the inlet and the outlet can define a flow channel through which the medically active fluid flows in the flow direction (X), or in other words, in the downstream direction. In certain embodiments, the outlet includes at least one ejection channel for ejecting the ejection flow of the medically active fluid. In other embodiments, the outlet includes at least two ejection channels adapted to eject at least two ejection flows of the medically active fluid. In further embodiments, such at least two liquid ejection flows are directed such that at least two ejection flows intersect or collide with each other to form an inhalable aerosol of the medically active fluid. In further embodiments, the cross-sectional width of the ejection channel or each ejection channel is from about 5 μm to about 15 μm, or from about 6 μm to about 10 μm, such as about 8 μm, and the height (corresponding to the height of the first-stage, second-stage, and third-stage microstructures described in detail below) is from about 2 μm to about 40 μm, generally from about 3 μm to about 20 μm, preferably from about 4 μm to about 14 μm, especially from about 5 μm to about 8 μm, or even from about 5 μm to about 7 μm.

[0039] The microstructured nozzle according to the present invention includes a main filter region that includes a main filter configured as a primary structure. The main filter is located within the main filter region of the microstructured nozzle according to the present invention and may be formed on the bottom plate and / or the cover plate, but preferably only on the bottom plate. In a preferred embodiment, as will be described in further detail below, the main filter is located and formed in the main filter region of the bottom plate. The term "region" as used herein, for example in connection with the main filter region, but also in connection with other regions such as the filtrate outlet region, the fluid distribution region, and the first and second interface regions described in detail below, refers to a specific part or section of the present microstructured nozzle, specifically a specific section of the surface of the present microstructured nozzle, and more specifically, a specific surface section that forms the flow channel of the present microstructured nozzle. More specifically, the term "region" may refer to the section of the bottom plate surface that forms the flow channel or, in other words, faces the flow channel. Even more specifically, the term "region" may refer to the section of the bottom plate surface that forms or faces the flow channel of the present microstructured nozzle, which is generally rectangular or square in shape, preferably generally rectangular. In some embodiments, such a rectangular or square, preferably rectangular, section of the flow channel may have a width that spans the entire flow channel from one sidewall to the opposite sidewall and may have a length that spans a fraction of the total length of the flow channel that connects the inlet and outlet of the present microstructured nozzle. The main filter includes a plurality of main filter protrusions arranged side by side in at least one row, and each main filter protrusion may be formed as a component of the bottom plate and protrude from the bottom plate. In addition, the main filter protrusions are spaced apart from each other by main filter channels that form a path for fluid to pass through the nozzle from the inlet to the outlet, while the cover plate, if attached to the bottom plate, covers the main filter protrusions and the main filter channels.

[0040] In some embodiments, the protrusions of the main filter (and the main filter region) extend across the entire width of the flow channel from one opposite sidewall to the other opposite sidewall. The term "width" as used herein, in connection with a structure having such a width, refers to the extension of such a structure in the plane of the flow channel but perpendicular to the flow direction. For example, in the case of the present bottom plate, it refers to the direction from one sidewall across to the opposite sidewall perpendicular to the flow direction. In contrast, the term "length" as used herein, in connection with a specific structure having such a length, refers to the extension of such a structure in the plane of the flow channel in the flow direction. For example, in the case of the present bottom plate, it refers to the direction from the inlet across to the outlet. Finally, the term "height" as used herein, in connection with a specific structure having such a height, refers to the extension of such a structure in a direction perpendicular to both the width and the length of such a structure.

[0041] In some embodiments, the main filter region can have a width ranging up to about 5 mm, such as from about 0.5 to about 4 mm, or from about 1 mm to about 4 mm, or from about 1.5 mm to about 2.5 mm, or from about 2 mm to about 3 mm (perpendicular to the flow direction), and a length (in the flow direction) from about 0.5 mm to about 1.5 mm, or from about 0.75 mm to about 1.25 mm. In some embodiments, the main filter region can have a constant width over the entire length of the main filter region, or in other words, from the upstream end or inlet of the main filter region to the downstream end or outlet of the main filter region.

[0042] In a specific embodiment, in the microstructured nozzle according to this aspect of the invention, the main filter includes a plurality of zigzag protrusions extending laterally from the bottom plate in a direction perpendicular to the flow direction, defining a plurality of channels and forming peaks in the inlet and outlet directions. In a further specific embodiment, the protrusions of the main filter are arranged side by side over the entire width of the filter, or in other words, from one side wall of the bottom plate to the opposite side wall of the bottom plate. Accordingly, in certain embodiments, the main filter includes a plurality of zigzag protrusions that extend in a direction perpendicular to the flow direction and extend across the entire width of the flow channel from one side wall of the bottom plate to the opposite side wall of the bottom plate.

[0043] As described above, the main filter includes a plurality of protrusions arranged in rows, preferably protruding in a zigzag manner from a preferably flat bottom plate and thus forming a part of the bottom plate. The bottom plate is preferably completely covered by a preferably flat cover plate. This forms a plurality of channels between the protrusions, the bottom plate, and the cover plate. These channels form the path of the filter nozzle from the inlet end to the outlet end. The spacing between the bottom plate in the area around the main filter protrusions and the cover plate inside a row of protrusions is approximately the same size as the width of the channels on the side of the protrusions, where the fluid enters the series of channels. The unfiltered fluid enters the main filter through an inlet, which can be one or more oval inlet slots. The inlet slot(s) has approximately the same height as the protrusions protruding from the bottom plate on the inlet side of the filter.

[0044] In an alternative embodiment, the protrusions of the main filter may be arranged in a cascade in several rows. The protrusions arranged closer to the inlet side of the filter may be larger than the protrusions arranged closer to the outlet side of the filter. Similarly, the spacing between the flat bottom plate and the flat cover plate in the surrounding area of each row of the protrusions of the main filter arranged in a cascade may be approximately the same size as the channel width on the side of the protrusion where the fluid enters the channel of that row. This spacing may be between half and twice the channel width. Viewed in the flow direction, the spacing may decrease row by row. Thus, the main filter channels may have a cross-section that is substantially square at their inlet end for the fluid. In all embodiments, the spacing between the flat bottom plate in the surrounding area of the protrusion and the flat cover plate inside the row of protrusions of the main filter may be constant. The spacing in the end region of the row closer to the outlet side of the main filter may be larger than the spacing in the end region of the row closer to the inlet side of the filter. The spacing preferably increases in a substantially linear manner from one end to the other end of the row of protrusions.

[0045] In some embodiments, the spacing between adjacent main filter protrusions, and correspondingly the width of the main filter channels, may be selected in the range from about 1 μm to about 25 μm, or from about 1.5 μm to about 15 μm, or from about 2 μm to about 10 μm. In a preferred embodiment, the spacing between adjacent main filter protrusions is selected to be from about 2 μm to about 5 μm. In some embodiments, the adjacent main filter elements are equally spaced apart such that all main filter channels have equal width.

[0046] The present microstructured nozzle further includes a filtrate outlet region, arranged between the main filter (or main filter region) and the microstructured nozzle outlet in the flow direction (downstream of the main filter region).

[0047] In certain embodiments, the filtrate outlet region is a region formed in the base plate and / or the cover plate, but preferably only in the base plate, which includes a hollow space into which the filtrate (i.e., the filtered medical active fluid) is received after passing through the main filter, or in other words, after leaving the main filter region. In some embodiments, the filtrate outlet region extends across the entire width of the flow channel from one opposing sidewall to the other opposing sidewall and, correspondingly, can have a width ranging up to about 5 mm, such as from about 0.5 to about 4 mm, or from about 1 to about 4 mm, or from about 1.5 to about 2.5 mm, or from about 2 to about 3 mm. The length (in the flow direction) of the filtrate outlet region can be from about 0.1 mm or from about 0.25 mm to about 1.5 mm, or from about 0.1 mm to about 0.6 mm, or from about 0.5 mm to about 1.25 mm. Although the width of the filtrate outlet region can vary within a broad range, for example as described above, in further specific embodiments, the filtrate outlet region has (approximately) the same width as the main filter region located upstream of the filtrate outlet region, or in other embodiments, has the same width as the downstream end of the main filter region located upstream of the filtrate outlet region. In further specific embodiments, the upstream end of the filtrate outlet region has (approximately) the same width as the (downstream end of the) main filter region located upstream of the filtrate outlet region.

[0048] In further specific embodiments, the filtrate outlet region does not include structural elements within the internal volume (of the hollow space) of the filtrate outlet region, such as primary or secondary structures included in the main filter region and the fluid distribution region. In yet further specific embodiments, the filtrate outlet region does not overlap with the main filter region (and thus also does not overlap with the fluid distribution region located upstream of the main filter region). In other words, in a preferred embodiment, the filtrate outlet region is a hollow space for receiving the filtered medical active fluid, which in certain embodiments can have a volume ranging from about 5% to about 10% of the total internal volume of the microstructured nozzle.

[0049] In certain embodiments, the filtrate outlet region can have the same width as the (downstream end of) the main filter region as described above and can gradually or discontinuously narrow in the direction towards the outlet end of the microstructured nozzle, or in further specific embodiments, can open into at least one outlet channel of the present microstructured nozzle.

[0050] The microstructured nozzle according to this aspect of the invention further includes a fluid distribution region which is arranged (in the flow direction) between the inlet and the main filter region. As will be further detailed below, the fluid distribution region is particularly suitable for distributing or diffusing the pressurized unfiltered fluid to be atomized / aerosolized before contacting the main filter.

[0051] In certain embodiments, the fluid distribution zone is an area formed on the bottom plate and / or the cover plate, preferably only on the bottom plate, which includes a hollow space in which a secondary structure as will be described in further detail below is provided. In some embodiments, the fluid distribution zone extends across the entire width of the flow channel from one sidewall to the opposite sidewall and may accordingly have a width ranging up to about 5 mm, such as from about 0.5 to about 4 mm, or from about 1 mm to about 4 mm, or from about 1.5 mm to about 2.5 mm, or from about 2 to 3 mm. The length (in the flow direction) of the fluid distribution zone may range from about 0.1 mm or about 0.25 mm to about 1.5 mm, or from about 0.1 mm to about 0.6 mm, or from about 0.5 mm to about 1.25 mm, preferably from about 0.1 mm to about 0.6 mm, or from about 0.2 mm to about 0.5 mm, or from about 0.3 mm to about 0.4 mm. Although the width of the fluid distribution zone can vary within a wide range, as described above, in further specific embodiments, the fluid distribution zone has the same width as (proximally) the main filter zone located downstream of the fluid distribution zone, or in alternative embodiments, has the same width as the upstream end of the main filter zone. In some embodiments, the fluid distribution zone has a generally constant or uniform width over the entire length of the fluid distribution zone. In further specific embodiments, the fluid distribution zone has a height (perpendicular to the above-mentioned width and length) of about 2 μm to about 40 μm, typically from about 3 μm to about 20 μm, preferably from about 4 to about 14 μm, particularly from about 5 μm to about 8 μm, or even from about 5 μm to about 7 μm.

[0052] A secondary structure is provided in the fluid distribution zone of the present microstructured nozzle, and the secondary structure includes a plurality of columnar built-in elements that extend laterally from the bottom plate and / or the cover plate in a direction transverse to the flow direction, preferably only from the bottom plate. To form the secondary structure in the fluid distribution zone, additional columnar built-in elements are constructed. Preferably, these built-in elements of the secondary structure extend from the bottom of the bottom plate to the cover plate in the form of a cylindrical facade. They are preferably cylinders with a circular cross-section. In certain embodiments, all of the columnar built-in elements of the secondary structure provided in the present microstructured nozzle are provided in the fluid distribution zone. Accordingly, in these embodiments, none of the columnar built-in elements of the secondary structure are provided in at least one of the main filter zone and the filtrate outlet zone, specifically, none of the columnar built-in elements of the secondary structure are provided in the filtrate outlet zone.

[0053] In a particular embodiment, the height of the built-in element corresponds to the height of the fluid distribution area as described above. In a further embodiment, the built-in element may be formed by the bottom plate or be part of the cover plate. In a preferred embodiment, the built-in element is formed as part of the bottom plate. In a still further embodiment, all main filter protrusions (of the primary structure) and all built-in elements (of the secondary structure) are formed as part of the bottom plate.

[0054] In an alternative embodiment, the built-in element may be formed by the bottom plate and by the cover plate. For example, some built-in elements may be formed entirely by the bottom plate and some built-in elements may be formed entirely by the cover plate. In a further alternative embodiment, the built-in element may be formed partly by the bottom plate and partly by the cover plate, such that when the bottom plate is covered by the cover plate, the respective parts of the corresponding built-in element are combined into the final built-in element. In a preferred embodiment, the cylindrical built-in element extends from the bottom plate to the cover plate.

[0055] In a particular embodiment, the size of the cylindrical built-in element of the secondary structure is selected such that it basically does not increase the flow resistance. This is achieved by creating a spacing between the built-in elements, with each spacing forming a flow-through channel for the liquid to pass through, such that the resulting cross-sectional area perpendicular to the flow direction (effectively permeable for the liquid) is greater than the corresponding effective cross-sectional area of the flow-through channel formed by the filter structure (more specifically, by the primary structure of the main filter). Therefore, the flow characteristics of the liquid in the nozzle are most affected by the main filter (primary) structure.

[0056] Accordingly, in a preferred embodiment, one or more spacings between the cylindrical built-in elements (each spacing forming a flow-through channel for the liquid to pass through) result in a resulting cross-sectional area transverse to the flow direction (effectively permeable for the liquid) that is greater than the corresponding effective cross-sectional area of the main filter channels formed by the main filter protrusions, such that the built-in element basically does not increase the flow resistance.

[0057] The cross-section of the built-in element is preferably selected such that the flow resistance during fluid flow is minimized. For this purpose, a cross-section that is preferably arcuate, circular or elliptical is selected. As an alternative to the above cross-sections, they may also be triangular, trapezoidal or rectangular, provided that the corners are aligned with the flow direction. However, in a preferred embodiment, the built-in element of the secondary structure of the fluid distribution area has a cylindrical peripheral wall. However, as an alternative, it may also be advantageously constructed with a concave or (alternatively) convex peripheral wall.

[0058] In a more preferred embodiment, the size, spacing, and arrangement of the cylindrical built-in elements of the second-stage structure relative to each other are such that the arrangement produced by the cylindrical built-in elements allows for the formation of an interface between the medically active fluid and the surrounding atmosphere, particularly at the upstream or downstream end, specifically at the downstream end of the second-stage structure, in order to allow for the formation of forces generated by surface tension when the medically active fluid comes into contact with the second-stage structure.

[0059] In a preferred embodiment, the built-in elements of the second-stage structure are arranged in parallel rows in an ABAB arrangement, which preferably has an equal-spacing interval both within rows A and B and between rows A and B. Adjacent rows A and B are preferably shifted in the flow direction by the diameter of the built-in elements. Accordingly, the use of built-in elements with a circular cross-section can produce a geometry where each built-in element forms the center of an equilateral hexagon, with each corner formed by an adjacent built-in element (hexagon design). In some embodiments, at least some of the built-in elements form an equilateral hexagon design, where the center of each hexagon design is formed by a built-in element and each corner of each hexagon design is formed by an adjacent built-in element.

[0060] Obviously, this only applies to a plurality of built-in elements surrounded by equilateral hexagons, and accordingly, does not apply to the built-in elements located at the edges, in other words, does not apply to the built-in elements adjacent to the upstream end, downstream end, or opposite sidewalls of the second-stage structure.

[0061] In a specific embodiment, the spacing of the cylindrical built-in elements of the second-stage structure can be selected in the range from about 5 μm to about 50 μm, or from about 5 μm to about 20 μm, or in the range from about 5 μm to about 15 μm, or from about 7.5 μm to about 12.5 μm, such as a spacing of 10 μm from each other to form the channels of the second-stage structure. In a further specific embodiment, the cylindrical built-in elements of the second-stage structure are uniformly and regularly distributed throughout the fluid distribution area. In a further specific embodiment, the spacing between adjacent cylindrical built-in elements is the same throughout the fluid distribution area. Even in a further embodiment, the plurality of channels of the second-stage structure have a constant diameter throughout the entire height of the second-stage structure.

[0062] According to a further specific embodiment, the cylindrical built-in elements have a diameter selected within a range from about 5 μm to about 50 μm, or from about 5 μm to about 20 μm, or in a range from about 5 μm to about 15 μm, or from about 7.5 μm to about 12.5 μm, such as 10 μm. In a preferred embodiment, all the cylindrical built-in elements of the secondary structure have the same cross-sectional shape, preferably a circular cross-sectional shape. In a further preferred embodiment, all the cylindrical built-in elements of the secondary structure have the same (cross-sectional) diameter and the same height. In a further preferred embodiment, as outlined above, the spacing between the cylindrical built-in elements of the secondary structure should be greater than the minimum spacing of the preferred zigzag filter structure of the main filter, which is located downstream of the secondary structure in the fluid distribution area.

[0063] In an advantageous embodiment, a plurality of cylindrical built-in elements can be arranged in a plurality of parallel rows, arranged transversely to the flow direction, and preferably extending from one side wall of the bottom plate to the opposite side wall. Further, in a specific embodiment, a plurality of cylindrical built-in elements are arranged in about 40 to about 70 parallel rows per mm (relative to the length of the secondary structure in the flow direction), preferably arranged in about 50 to 60 parallel rows per mm, extending from one side wall to the opposite side wall.

[0064] In a still further embodiment, a plurality of cylindrical built-in elements of the secondary structure can be arranged in about 10 to about 30 rows, preferably about 15 to about 25 parallel rows, with the rows extending from one side wall to the opposite side wall perpendicular to the flow direction. In a further embodiment, each row of cylindrical built-in elements of the secondary structure can include from about 40 to about 60 built-in elements per mm, most preferably from about 45 to about 55 built-in elements per mm. In a specific embodiment, each row of cylindrical built-in elements of the secondary structure can include from about 80 to about 120 built-in elements, preferably about 90 to about 110 built-in elements per row.

[0065] In these embodiments, especially in the case where the rows are arranged relative to each other in the ABAB arrangement as described above, a high density of cylindrical built-in elements can be achieved in the secondary structure located in the fluid distribution area, per cm 2 (with respect to the surface of the fluid distribution area) the number of built-in elements ranges from about 200,000 (two hundred thousand) to about 300,000, or from about 250,000 to about 300,000. Correspondingly, in a preferred embodiment, the number of built-in elements provided in the fluid distribution area is per cm 2 from about 200,000 to about 300,000, or per cm 2 from about 250,000 to about 300,000.

[0066] As detailed above, in the flow direction of the medically active fluid, the fluid distribution zone is arranged between the inlet and the main filter zone. However, in a preferred embodiment, the fluid distribution zone does not overlap with the main filter zone, while in a specific embodiment, it is possible for the fluid distribution zone to be adjacent to the main filter zone. In other words, in some embodiments, the downstream end of the fluid distribution zone may be in contact with the upstream end of the main filter zone. However, in a further embodiment, the cylindrical built-in element of the fluid distribution zone does not contact the main filter zone, in particular does not contact the protrusions of the primary structure located within the main filter zone.

[0067] In a preferred embodiment, the fluid distribution zone of the present microstructured nozzle, or more specifically, the second-stage structure including the arrangement of the cylindrical built-in elements provided therein, allows for a more uniform and equal (or in other words, homogeneous) distribution of the medically active fluid to be filtered and sprayed over a wider section or even the entire width of the main filter (especially in a situation where the medically active liquid cannot enter the inlet of the microstructured nozzle uniformly over the entire width of the fluid channel extending from one side wall to the other side wall). This can be particularly advantageous in cases where the pressurized medically active fluid is delivered to the inlet of the microstructured nozzle from a pumping unit or other pressure source through a pipe or other fluid connection having a cross-sectional diameter smaller than the width of the inlet of the microstructured nozzle. In these cases, the pressurized medically active fluid enters the second-stage structure of the fluid distribution zone at its upstream end (facing the inlet of the microstructured nozzle) and fills the fluid channels located between the cylindrical built-in elements before passing through the filter channels of the primary structure of the main filter, especially in a situation where, according to the preferred embodiment of the present microstructured nozzle, the spacing between the built-in elements of the second-stage structure results in a cross-sectional area effective transversely to the flow direction (effectively permeable for the medically active fluid) that is greater than the corresponding effective cross-sectional surface area of the main filter channels formed by the protrusions of the main filter.

[0068] In addition, in a preferred embodiment, the secondary structure provided in the fluid distribution zone, as described above, in particular, when provided in the form of parallel rows in an ABAB arrangement (with preferably equidistant spacing within rows A and B and between rows A and B), allows the formation of a fluid-gas interface, preferably at the most downstream row of the cylindrical in-built elements, in the case where the medical active fluid to be sprayed moves or retracts in the upstream direction (i.e., from the main filter zone towards the inlet of the microstructured nozzle). This can become relevant in the case where the pressure applied to the medical active fluid is (partially) released or even revoked, for example, after the injection and spraying of the pressurized medical active fluid through at least one injection channel. In addition, this becomes relevant in the case where the medical active fluid remaining in the microstructured nozzle is exposed to a negative pressure, or in other words, underpressure, for example, during the start-up phase of a pump, exposed to the underpressure generated by a pumping unit that includes a pumping chamber and a piston that can reciprocate therein. In these cases, according to the capillary forces acting between the medical active fluid and the array of cylindrical in-built elements at the fluid-gas interface at the downstream end of the fluid distribution zone, the secondary structure including the array of cylindrical in-built elements can act as a microfluidic valve to avoid or reduce the backflow of the medical active fluid in the upstream direction.

[0069] In a preferred embodiment, the secondary structure located within the fluid distribution region is provided in such a form that the forces acting between the medical active fluid and the array of cylindrical in-built elements are defined and as uniform as possible, independent of the actual position of the boundary line between the medical active fluid and the surrounding atmosphere. This is especially the case when the array of cylindrical in-built elements is provided in the form of equidistant parallel rows, in particular when the boundary line is located at the most downstream row of the in-built element array. However, in the case where a plurality of cylindrical in-built elements of the same size are evenly distributed throughout the fluid distribution zone, the forces acting between the medical active fluid and the cylindrical structure at the boundary line (corresponding to the Laplace pressure when the medical active fluid contacts the plurality of cylindrical in-built elements) may be uniform, independent of the actual position of the boundary line (assuming that the medical active fluid will form a linear or almost linear boundary line or meniscus perpendicular to the flow direction between the opposite sides of the liquid channel). Accordingly, in the preferred embodiment outlined above, the secondary structure is provided in the form of an array of uniform cylindrical in-built elements with a cylindrical peripheral wall, arranged in equidistant parallel rows, preferably in an ABAB configuration, as detailed above.

[0070] As described above, this can be advantageous if the forces acting between the medically active fluid and the array of cylindrical internal elements are defined and as consistent as possible, independent of the actual position of the boundary line between the medically active fluid and the surrounding atmosphere (corresponding to the fluid-gas interface), especially in the case where the second-level structure of the cylindrical internal elements acts as a microfluidic valve or gate regulating the backflow of the medically active fluid in the upstream direction, as described above. To provide consistent and defined forces acting on the medically active fluid and the array of cylindrical boundary elements, it can be advantageous when the width of the fluid distribution zone, especially the width of the array of cylindrical boundary elements provided in the fluid distribution zone, is constant or substantially constant over the entire length of the fluid distribution zone. Additionally, in an advantageous embodiment, the cross-sectional area of the fluid distribution zone (perpendicular to the flow direction), or more specifically, the part of the flow channel spanning the fluid distribution zone, is constant or substantially constant over the entire length of the fluid distribution zone. In the case where the height of the flow channel is constant or substantially constant, this can be achieved by a constant width over the entire length of the flow channel.

[0071] Furthermore, it has also been found that the positioning of the array of cylindrical internal elements of the second-level structure in the upstream region of the main filter zone, or in other words, on the high-pressure side of the main filter zone (the side where the pressurized medically active fluid impinges on the main filter), can advantageously provide further stabilization of the connection between the bottom plate and the cover plate of the present microstructured nozzle. This can be particularly beneficial in reducing or preventing potential deformation of the bottom plate and / or the cover plate under the action of the medically active fluid at high pressures (up to 300 bar and even higher), which can severely affect the positioning of the microstructures provided on the bottom plate and their connection to the cover plate, and correspondingly, can severely affect the tightness of the present microstructured nozzle or the flow channels provided therein.

[0072] In a further specific embodiment, the present microstructured nozzle can also include a first interface zone located in the flow direction between the (exit or downstream end) of the fluid distribution zone and the (entrance or upstream end) of the main filter zone, where the first interface zone does not include structural elements located within the first interface zone, thus supporting the formation of a fluid-gas interface at the exit side of the distribution zone.

[0073] In certain embodiments, this first interface region can be a hollow space located between fluid distribution regions, which in some embodiments has a width and height that are generally equivalent to the width and height of the fluid distribution region (at its downstream end) upstream of the first interface region, and equivalent to the width and height of the main filter region (at its upstream end) downstream of the first interface region, both as detailed above. In alternative embodiments, however, the first interface region can also have different dimensions, for example, a width that is narrower than one or both of the adjacent regions, while the height is the same as that of the adjacent regions. In some embodiments, the first interface region extends across the entire width of the flow channel from one opposing sidewall to the other opposing sidewall, and correspondingly, can have a width in the range of up to about 5 mm, such as from about 0.5 mm to about 4 mm, or from about 1 mm to about 4 mm, or from about 1.5 mm to about 2.5 mm, or from about 2 mm to about 3 mm. In further embodiments, the length of the first interface region, or in other words, the distance by which the main filter region and the fluid distribution region are spaced apart by it, can vary over a wide range, for example, can be selected in the range from about 0.01 mm to about 0.5 mm, or from about 0.01 mm to about 0.1 mm, or up to about 0.05 mm.

[0074] In a further specific embodiment, this microstructured nozzle can further include a second interface region located between the inlet of the microstructured nozzle and the inlet (or upstream end) of the fluid distribution region, where the second interface region also does not include structural elements located within the second interface region, thus supporting the formation of a fluid-gas interface at the inlet side of the fluid distribution region.

[0075] In certain embodiments, this second interface region can be a hollow space located between the inlet (of the microstructured nozzle) and the inlet (or upstream end) of the fluid distribution region, which in some embodiments has a width and height that are generally equivalent to the width and height of the fluid distribution region downstream of the second interface region, and equivalent to the width and height of the microstructured nozzle inlet upstream of the second interface region, both as detailed above. In alternative embodiments, however, the second interface region can also have different dimensions, for example, a width that is narrower than the inlet or the fluid distribution region, while the height is the same as the height of the inlet and the fluid distribution region. In some embodiments, the second interface region extends across the entire width of the flow channel from one opposing sidewall to the other opposing sidewall, and correspondingly, has a width in the range of up to about 5 mm, such as from about 0.5 to about 4 mm, or from about 1 to about 4 mm, or from about 1.5 to about 2.5 mm, or from about 2 to about 3 mm. In further embodiments, the length of the second interface region, or in other words, the distance by which the microstructured nozzle inlet and the fluid distribution region are spaced apart by it, can vary over a wide range, for example, can be selected in the range from about 0.01 mm to about 0.5 mm, or from about 0.01 mm to about 0.1 mm, or up to about 0.05 mm.

[0076] In a further embodiment, the microstructured nozzle may include a coarse filter region located between the inlet (of the microstructured nozzle) and the inlet or upstream end of the fluid distribution region or (if present) the second interface region. The coarse filter region includes a coarse filter configured as a third-level structure, having a plurality of coarse filter protrusions arranged side by side in at least one row, each protrusion being formed as part of the bottom plate and protruding from the bottom plate. The protrusions are spaced from each other by coarse filter channels, which form a path for the fluid to pass through the nozzle from the inlet to the outlet, while the cover plate, if attached to the bottom plate, covers the coarse filter protrusions and the coarse filter channels.

[0077] According to these embodiments, the optional coarse filter region of the microstructured nozzle includes a coarse filter region that includes a coarse filter configured as a third-level structure. The coarse filter, if present, is preferably located on and formed in the coarse filter region of the bottom plate, as will be further detailed below. In certain embodiments, the coarse filter may include a plurality of coarse filter protrusions arranged side by side in at least one row, preferably one row, and preferably each coarse filter protrusion is part of the bottom plate and may protrude from the bottom plate. Additionally, the coarse filter protrusions, if present, may be spaced from each other by coarse filter channels, which form a plurality of paths for the fluid to pass from the inlet to the outlet (through the second interface region (if present), the fluid distribution region, the first interface region (if present), and the main filter region), while the cover plate, if attached to the bottom plate, covers the coarse filter protrusions and the coarse filter channels.

[0078] In certain embodiments, the coarse filter region extends across the entire width of the flow channel from one opposing sidewall to the other opposing sidewall and, correspondingly, has a width that can range up to about 5 mm, such as from about 0.5 to about 4 mm, or from about 1 mm to about 4 mm, or from about 1.5 mm to about 2.5 mm, or from about 2 mm to 3 mm, and a length (in the flow direction) from about 0.05 mm to about 0.5 mm, or from about 0.1 mm to about 0.3 mm, or up to about 0.2 mm.

[0079] In a particular embodiment, in the microstructured nozzle according to this aspect of the invention, the coarse filter includes a plurality of protrusions extending transversely from the bottom plate in a direction perpendicular to the flow direction to define a plurality of coarse filter channels. In a preferred embodiment, the coarse filter protrusions may have a rectangular or square cross-sectional shape, but may also be other shapes, such as circular, oval or irregular shapes. In a further particular embodiment, the protrusions of the coarse filter are arranged side by side across the entire width of the coarse filter region, or in other words, from one side wall of the bottom plate to the opposite side wall of the bottom plate. In some embodiments, the width of the coarse filter protrusions perpendicular to the flow direction may be from about 0.01 mm to about 0.1 mm, or from about 0.025 mm to about 0.075 mm, and the length (in the flow direction) is from about 0.05 mm to about 0.3 mm, or from about 0.1 mm to about 0.3 mm, or up to about 0.2 mm. In a further embodiment, the coarse filter protrusions may be evenly distributed across the entire width of the flow channel, preferably at a density of from about 3 to about 7 protrusions per centimeter. In a further embodiment, the width of the coarse filter channels may be from about 0.05 mm to about 0.3 mm, or from about 0.1 mm to about 0.2 mm.

[0080] As detailed above, the present microstructured nozzle at least includes an inlet, an outlet, and, located between the inlet and the outlet in the flow direction: - A fluid distribution region located downstream of the inlet, including a second-stage structure of cylindrical built-in elements, - A main filter region located downstream of the fluid distribution region, including a main filter as a primary structure, and - A filtrate outlet region located downstream of the main filter region.

[0081] In a further embodiment, the present microstructured nozzle at least includes an inlet, an outlet, and, located between the inlet and the outlet in the flow direction: - A fluid distribution region located downstream of the inlet, including a second-stage structure of cylindrical built-in elements, - A first interface region located downstream of the fluid distribution region, - A main filter region located downstream of the first interface region, including a main filter as a primary structure, and - A filtrate outlet region located downstream of the main filter region.

[0082] In a further embodiment, the present microstructured nozzle at least includes an inlet, an outlet, and, located between the inlet and the outlet in the flow direction: - A second interface region located downstream of the inlet, - A fluid distribution region located downstream of the second interface region, including a second-stage structure of cylindrical built-in elements, - A first interface region located downstream of the fluid distribution region, - A main filter area downstream of the first interface area, including a main filter as a primary structure, and - A filtrate outlet area downstream of the main filter area.

[0083] In a further embodiment, the present microstructured nozzle at least comprises an inlet, an outlet and, between the inlet and the outlet in the flow direction: - A coarse filter area downstream of the inlet, including a coarse filter as a third-stage structure, - A second interface area downstream of the coarse filter area, - A fluid distribution area downstream of the second interface area, including a second-stage structure of a cylindrical built-in element, - A first interface area downstream of the fluid distribution area, - A main filter area downstream of the first interface area, including a main filter as a primary structure, and - A filtrate outlet area downstream of the main filter area.

[0084] As described above, the present microstructured nozzle can be included in an inhalation device, or in other words, an atomizer or nebulizer for inhalation therapy includes it. Accordingly, in a second aspect, the present invention provides an inhalation device for inhalation therapy, which device comprises a microstructured nozzle according to the first aspect of the present invention. To avoid doubt, it should be noted that all features, embodiments, explanations or combinations thereof related to the microstructured nozzle of the first aspect of the present invention described in detail above are equally applicable (where applicable) to the inhalation device of the second aspect of the present invention.

[0085] As described above, inhalation devices for generating an inhalable aerosol of a medicinally active fluid have been described in the prior art, such as US2005 / 0001076 A1 discussed above and the references cited therein. Another inhalation device has been disclosed in WO 2018 / 197730 A1, the content of which is incorporated herein by reference in its entirety. These inhalation devices generally have a small size so that they can be held and operated by a user with one hand. They typically include a reservoir for containing the medicinally active fluid to be aerosolized and administered, a pumping unit for pressurizing the medicinally active fluid, in particular a pumping unit adapted to generate a discontinuous, defined volume of highly pressurized medicinally active fluid, a drive mechanism, and a nozzle unit through which the medicinally active fluid pressurized by the pumping unit is aerosolized, or in other words, sprayed. The defined volume of the medicinally active fluid to be aerosolized can be selected within a wide range, and in certain embodiments, can be selected in the range from about 1 μL to about 50 μL, or from about 10 μL to about 25 μL, such as about 15 μL. According to a second aspect of the present invention, the inhalation device includes the microstructured nozzle according to the first aspect of the present invention described in detail above. Due to the advantages of the microstructured nozzle according to the first aspect of the present invention described above, the inhalation device according to the second aspect of the present invention allows for a simplified design of such an inhalation device, and due to the advantageous characteristics of the interaction of the microstructured nozzle with the other functional units of the inhalation device of the present invention, allows for a longer service life of the inhalation device. These advantageous characteristics can include, but are not limited to, enhanced mechanical robustness and advantageous filtration characteristics, which in particular allow for a simplified design of other units of the inhalation device (such as the pumping unit).

[0086] Among other things, the present invention also relates to the following specific embodiments:

[0087] 1. A microstructured nozzle (1) for a device (100) for generating an inhalable aerosol of a medicinally active fluid (2), the microstructured nozzle having a main filter (21), an inlet (3) for unfiltered fluid, and an outlet (4) for filtered fluid, the inlet and the outlet defining a flow direction (X) of the fluid from the inlet to the outlet, the nozzle comprising: - a substantially flat bottom plate (5) and a cover plate (6) attachable thereto; - a main filter region (20) including a main filter (21) configured as a primary structure having a plurality of main filter protrusions (22) arranged side by side in at least one row (23), each main filter protrusion being formed as an integral part of the bottom plate and protruding from the bottom plate, the main filter protrusions being spaced apart from each other by main filter channels (24) that form a path for the fluid to pass through the nozzle from the inlet to the outlet, and the cover plate, if attached to the bottom plate, covering the main filter protrusions and the main filter channels; - A filtrate outlet region (30), disposed between the main filter and the outlet in the flow direction; and - A fluid distribution region (40), disposed between the inlet and the main filter in the flow direction (for the distribution of unfiltered fluid before contacting the main filter), - wherein, a second-stage structure (41) is provided in the fluid distribution region, the second-stage structure includes a plurality of columnar built-in elements (42), and the built-in elements extend transversely to the flow direction from the bottom plate and / or the cover plate.

[0088] 2. The microstructured nozzle according to item 1, wherein the inlet is located at the inlet end (7) of the bottom plate, the outlet is located at the opposite outlet end (8) of the bottom plate, the inlet and the outlet are connected by opposite side walls (9, 10), the inlet and the outlet define a flow channel (11), and the medically active fluid passes through the channel in the flow direction (X), wherein the outlet includes at least one ejection channel (12) for ejecting an ejection flow of the medically active fluid.

[0089] 3. The microstructured nozzle (1) according to item 2, wherein the protrusions (22) of the main filter (21) are arranged to extend from one side wall (9) of the bottom plate (5) to the opposite side wall (10) of the bottom plate (5).

[0090] 4. The microstructured nozzle according to any one of the preceding items, wherein the outlet includes at least two ejection channels, adapted to eject at least two ejection flows of the medically active fluid, so that the at least two ejection flows intersect each other to form an inhalable aerosol.

[0091] 5. The microstructured nozzle according to any one of the preceding items, wherein the main filter includes a plurality of zigzag protrusions extending transversely to the flow direction from the bottom plate to define a plurality of channels (24) and form peaks (25) in the inlet and outlet directions.

[0092] 6. The microstructured nozzle according to any one of the preceding items, wherein the filtrate outlet region does not include a structural element located in the internal volume of the filtrate outlet region.

[0093] 7. The microstructured nozzle according to any one of the preceding items, wherein one or more spacings between the built-in elements (each spacing forms a flow-through channel for the liquid to pass through) are such that the resulting effective cross-sectional area of the liquid permeable transversely to the flow direction is greater than the corresponding effective cross-sectional area of the main filter flow channel formed by the protrusions of the main filter, so that the built-in elements basically do not increase the flow resistance.

[0094] 8. The microstructured nozzle according to any one of the preceding items, wherein the built-in elements in the fluid distribution region have a cylindrical peripheral wall.

[0095] 9. The microstructured nozzle according to any one of the foregoing, wherein the distance between the built-in elements is from about 0.005 mm to about 0.02 mm.

[0096] 10. The microstructured nozzle according to any one of the foregoing, wherein the built-in elements have a diameter of from about 0.005 mm to about 0.02 mm.

[0097] 11. The microstructured nozzle according to any one of the foregoing, wherein the cylindrical built-in elements extend from the bottom plate to the cover plate.

[0098] 12. The microstructured nozzle according to any one of the foregoing, wherein the protrusions of the main filter are arranged side by side across the entire width of the filter.

[0099] 13. The microstructured nozzle according to any one of the foregoing, wherein the built-in elements are formed as an integral part of the bottom plate.

[0100] 14. The microstructured nozzle according to any one of the foregoing, wherein all the main filter protrusions and all the built-in elements are formed as an integral part of the bottom plate.

[0101] 15. The microstructured nozzle according to any one of the foregoing, wherein a plurality of cylindrical built-in elements are arranged in a plurality of parallel rows (33) arranged transversely to the flow direction.

[0102] 16. The microstructured nozzle according to any one of the foregoing, wherein a plurality of cylindrical built-in elements are arranged in about 40 to 70 parallel rows per mm (relative to the length of the second-stage structure in the flow direction), preferably in about 50 to 60 parallel rows per mm, extending from one side wall to the opposite side wall.

[0103] 17. The microstructured nozzle according to any one of the foregoing, wherein a plurality of cylindrical built-in elements are arranged in about 10 to about 30 rows, preferably about 15 to about 25 rows, with the rows extending perpendicular to the flow direction from one side wall to the opposite side wall.

[0104] 18. The microstructured nozzle according to any one of the foregoing, wherein each row of cylindrical built-in elements of the second-stage structure includes about 40 to about 60 built-in elements per mm, preferably from about 45 to about 55 per mm.

[0105] 19. The microstructured nozzle according to any one of the foregoing, wherein each row of cylindrical built-in elements of the second-stage structure includes about 80 to about 120 built-in elements, preferably each row includes from about 90 to about 110.

[0106] 20. The microstructured nozzle according to any one of the preceding claims, wherein at least some of the built-in elements form an equilateral hexagon design, wherein the center of each hexagon design is formed by a built-in element, and each corner of each hexagon design is formed by an adjacent built-in element.

[0107] 21. The microstructured nozzle according to any one of the preceding claims, wherein the built-in elements are provided in the fluid distribution area in a number of about 200,000 to about 300,000 per cm 2 in the fluid distribution area.

[0108] 22. The microstructured nozzle according to any one of the preceding claims, wherein the fluid distribution area does not overlap with the main filter area.

[0109] 23. The microstructured nozzle according to any one of the preceding claims, wherein the built-in elements (of the second-level structure) in the fluid distribution area do not contact the main filter area.

[0110] 24. The microstructured nozzle according to any one of the preceding claims, wherein the width of the fluid distribution area, in particular the width of the array of cylindrical boundary elements provided in the fluid distribution area, is constant or substantially constant over the entire length of the fluid distribution area.

[0111] 25. The microstructured nozzle according to any one of the preceding claims, comprising a first interface area (50) located between the fluid distribution area and the main filter area in the flow direction, wherein the first interface area does not include structural elements located within the first interface area.

[0112] 26. The microstructured nozzle according to any one of the preceding claims, comprising a second interface area (60) located between the inlet and the fluid distribution area in the flow direction, wherein the second interface area does not include structural elements located within the second interface area.

[0113] 27. The microstructured nozzle according to any one of the preceding claims, comprising a coarse filter area (70) located between the inlet and the fluid distribution area or the second interface area, the coarse filter area including a coarse filter (71) configured as a third-level structure, having a plurality of coarse filter protrusions (72) arranged side by side in at least one row, each protrusion being formed as a part of the bottom plate and protruding from the bottom plate, the protrusions being spaced apart from each other by coarse filter channels (73), the coarse filter channels forming a path for the fluid to pass through the nozzle from the inlet to the outlet, and a cover plate covering the coarse filter protrusions and the coarse filter channels if the cover plate is attached to the bottom plate.

[0114] 28. An inhalation device (100) for inhalation therapy, comprising the microstructured nozzle according to any one of claims 1 to 27. Detailed description of the drawings

[0115] Figure 1There is shown an inhalation device (100), comprising an inhalation device unit (110) and an exchangeable reservoir (120), which is in the form of a cartridge insertable into the inhalation device (100) and contains a medically active fluid (2). The inhalation device unit (110) has a housing (111) with a lower part (112) that can be detached and removed from the inhalation device unit (110) to open the housing (111) and allow access to a receiving unit (113) into which the exchangeable reservoir (120) in the form of a cartridge can be inserted. The receiving unit (113) also has a connection unit (114) adapted for releasable and fluid connection with a connection port of the exchangeable reservoir (120).

[0116] The inhalation device unit (110) also has a microstructured nozzle (1) located at the downstream end of the inhalation device unit (110) for atomization of the medically active fluid (2). The inhalation device (100) also has a pumping unit (130) arranged within the housing (111). As detailed above, the pumping unit (130) is fluidly connected to the reservoir (120) (via the connection unit (114) of the receiving unit (113)) and the nozzle (1) and is adapted to pump the medically active fluid (2) in a downstream direction from the reservoir (120) to the nozzle (1).

[0117] The pumping unit (130) has an upstream end (131) fluidly connected to the exchangeable reservoir (120) and a downstream end (132) fluidly connected to the nozzle (1), wherein the pumping unit (130) further comprises (i) a riser (133) having an upstream end (134), wherein the riser (133) is adapted to function as a piston within the pumping unit (130), and wherein the riser (133) is firmly fixed to the user (downstream) side of the housing (111) so as to be stable and immovable relative to the housing (111), and (ii) a hollow cylinder (135) located upstream of the riser (133), wherein the upstream end (134) of the riser is inserted into the cylinder (135) such that the cylinder (135) is movable longitudinally along the riser (133).

[0118] As Figure 1 shown, the pumping device (130) comprises (iii) a lockable device (136) for storing potential energy upon locking and releasing the stored potential energy upon unlocking, which device (136) is arranged outside the cylinder (135) and is mechanically coupled to the cylinder such that unlocking the device (136) causes a propulsive longitudinal movement of the cylinder (135) towards the downstream end of the pumping unit (132), thereby causing ejection of the pressurized medically active fluid (2) through the microstructured nozzle (1).

[0119] Figure 2Describes an embodiment of the bottom plate (5) of the present microfluidic nozzle (1), which, when viewed from the side, is initially open and can subsequently be covered with a cover plate (6) (see Figure 5A / B). The microfluidic nozzle (1) has an inlet (3) located at the inlet end (7) of the bottom plate and an outlet (4) located at the outlet end (8) of the bottom plate (5), and the inlet (3, 7) and the outlet (4, 8) define the flow direction (X) of the medical active fluid in the downstream direction from the inlet (3, 7) towards the outlet (4, 8). The outlet (4) includes two injection channels (12) through which the injection flow of the medical active fluid can be ejected.

[0120] As Figure 2 shown, the bottom plate (5) includes a main filter area (20), and the main filter area (20) includes a main filter (21) configured as a primary structure. The main filter (21) includes a plurality of main filter protrusions (22), which are arranged side by side in at least one row (23) (as Figure 4 shown in more detail), folded into a zigzag-like structure, forming peaks (25), and extending from one side wall (9) to the opposite side wall (10), thus extending across the entire width of the flow channel (11). Each main filter protrusion (22) forms a component of the bottom plate and protrudes therefrom (perpendicular to the plane of the protrusion). As Figure 4 shown in the enlarged detail of, the main filter protrusions (22) are spaced from each other by main filter channels (24), and the main filter channels form a path for the fluid to pass through the nozzle from the inlet (3, 7) to the outlet (4, 8). The inlet (3, 7) and the outlet (4, 8) are connected through the opposite side walls (9, 10) of the bottom plate (5), thus defining the flow channel (11), and the medical active fluid flows through this flow channel from the inlet (3, 7) in the downstream direction towards the outlet (4, 8), and more specifically, towards the injection channels (12).

[0121] The bottom plate (5) further includes a filtrate outlet area (30), which is arranged between the main filter area (20) or the main filter (21) and the outlet (4, 8), and this outlet has injection channels (12) in the flow direction. As Figure 2 can be seen from the embodiment of, the filtrate outlet area (30) is a hollow space or volume, in which there is no structural element connecting the downstream end of the main filter area (20) to the outlet (4, 8) and the injection channels (12).

[0122] In addition, as Figure 2 shown in the embodiment of the bottom plate (5), it includes a fluid distribution area (40), which is arranged between the inlet (3, 7) and the main filter area (20) in the flow direction. In the fluid distribution area (40), a secondary structure (41) is provided, which is in the form of an array of a plurality of uniformly spaced columnar built-in elements (42) extending from the bottom plate (5). InFigure 2 In Figure 2 , since the plurality of cylindrical built-in elements (42) of the second-level structure (41) are in a top view, they are shown as circles corresponding to the top surfaces of the plurality of cylindrical struts (42) having a circular cross-section. From Figure 3 As can be best seen from the enlarged detail of Figure 3 , the plurality of cylindrical built-in elements (42) shown in this embodiment are arranged in a plurality of parallel rows (43), and the rows are arranged transversely to the flow direction (X). Further, in the specific embodiment shown, the rows (43) of the cylindrical built-in elements (42) are arranged in an "ABAB" arrangement, preferably with equal spacing within rows A and B and between rows A and B, such that the built-in elements (42) not adjacent to the upstream or downstream ends of the fluid distribution zone (40) or not adjacent to the opposite side walls (9, 10) form an equilateral hexagonal design, where the center of each hexagonal design is formed by a built-in element (42), and each corner of each hexagonal design is formed by an adjacent built-in element (42). The cylindrical built-in elements (42) of the second-level structure (41) are spaced from each other by channels (44) of the second-level structure.

[0123] From Figure 2 It can also be seen from Figure 2 that the fluid distribution zone (40) does not overlap with the main filter zone (20), and more specifically, the cylindrical built-in elements (42) located in the fluid distribution zone (40) do not contact the main filter zone (20). Further, in Figure 2 the embodiment shown, the fluid distribution zone (40) is uniformly equipped with an array of cylindrical built-in elements (42). Further, the width of the fluid distribution zone (40) perpendicular to the flow direction (X) and the width of the array of cylindrical built-in elements (42) provided within the fluid distribution zone (40) are constant or substantially constant throughout the length of the fluid distribution zone (40), and extend from one opposite side wall (9) to the other side wall (10).

[0124] As Figure 2 shown, the bottom plate (5) also includes a first interface zone (50) located between the fluid distribution zone (40) and the main filter zone (20) in the flow direction (X). As can be seen from this embodiment, the first interface zone (50) does not include structural elements located within the first interface zone (50) to create a hollow space or volume to space and connect the downstream end of the fluid distribution zone (40) from / to the upstream end of the main filter zone (20) and the main filter (21) located therein.

[0125] Further, as Figure 2As shown, the bottom plate (5) further includes a second interface region (60) that is located between the inlets (3, 7) and the fluid distribution region (40) in the flow direction (X). As can be seen from this embodiment, the second interface region (60) also does not include structural elements located within the second interface region (60) to create a hollow space or volume that spaces and connects the inlets (3, 7) (or more specifically, the coarse filter region (70) described later) from / to the upstream end of the fluid distribution region (40) and the cylindrical built-in element (42) located therein.

[0126] According to Figure 2 the embodiment shown, the bottom plate (5) further includes a coarse filter region (70) that is located between the inlets (3, 7) and the fluid distribution region (40) in the flow direction (X), or more specifically, between the inlets (3, 7) and the second interface region (60). The coarse filter region (70) includes a coarse filter (71) configured as a third-stage structure and having a plurality of coarse filter protrusions (72). In Figure 2 the embodiment shown, the coarse filter protrusions (72) are provided in the form of a rectangular structure, like the protrusions (22) of the main filter (21) and the cylindrical built-in element (42) of the second-stage structure, and are integrally formed with the bottom plate (5) and protrude perpendicular to the projection plane of the bottom plate (5). In Figure 2 the embodiment shown, the coarse filter protrusions (72) are arranged side by side in a row of protrusions of equal size and shape, and each protrusion forms a component part of the bottom plate and protrudes from the bottom plate. The coarse filter protrusions (72) are separated from each other by coarse filter channels (73), and the coarse filter channels (73) form a path for the pharmaceutically active fluid to pass from the inlets (3, 7) to the outlets (4, 8) through the nozzles, while the cover plate (6, see Figure 5A / B) covers the coarse filter protrusions (72) and the coarse filter channels (73) if attached to the bottom plate (5).

[0127] From Figure 2 it can also be seen that the width of the coarse filter channels (73) perpendicular to the flow direction (X) is greater than the width of the channels (44) between the cylindrical built-in elements (42), and in some embodiments, an order of magnitude greater, before the pharmaceutically active fluid contacts the second-stage structure or the main filter (21) of the fluid distribution region (40) to filter out any coarse physical impurities or debris it may contain.

[0128] Figure 3 An enlarged top view of the cylindrical built-in element (42) of the second-stage structure in the fluid distribution region (40) is shown, specifically adjacent to the left side wall (9), as well as adjacent to the first interface region (50) located downstream of the fluid distribution region (40), and an enlarged detail of a portion of the second-stage structure adjacent to the second interface region (60) located upstream. In as Figure 3In the illustrated embodiment, the cylindrical built-in elements (42) of the second-level structure are provided in an array that includes equidistant rows (43) of a plurality of equidistantly spaced built-in elements (42), such as the ABAB configuration described in detail above. In this embodiment, the top or most downstream row of cylindrical built-in elements corresponds to row A, where the second most downstream row corresponds to row B, followed by row A again, and so on. Most notably, due to this structure, there are only two different distances between the side wall (9) and the corresponding groups of rows, resulting in the formation of defined capillary forces acting between the side wall, the cylindrical built-in elements (42), and the medically active fluid.

[0129] Figure 4 Fig. 5 shows an enlarged top plan view of a portion of the main filter (21) located in the main filter area (20), having main filter protrusions (22) arranged in a row (23) and separated by main filter channels (24). More specifically, Fig. 5 shows Figure 2 the peaks (25) of the illustrated zigzag main filter (21).

[0130] Figure 5A and 5B Fig. 6 shows a perspective view of the microstructured nozzle (1) according to the invention, including a bottom plate (5) and a cover plate (6) attached to each other, thus forming the fully assembled microstructured nozzle (1). More specifically, Figure 5A Fig. 7 shows the upstream end (7) of the assembled microstructured nozzle (1), having an inlet (3) and a coarse filter protrusion (72) and a coarse filter channel (73), while Figure 5B Fig. 8 shows the opposite downstream end (8) of the assembled microstructured nozzle (1) having two injection channels (12).

[0131] Finally, Figure 6 Fig. 9 shows a perspective view of a section of the bottom plate (5) of the microstructured nozzle (1), such as Figure 2 shown in the top plan view. The shown section includes the main filter (21) located in the main filter area (20), the second-level structure (41) of the fluid distribution area (40) having columnar built-in elements (42) spaced by channels (44) of the second-level structure, and a portion of the coarse filter protrusion (72) having a coarse filter channel (73). Due to the perspective projection, the heights of the primary, second-level, and third-level structures can be seen, i.e., the heights of the main filter protrusions (22), the columnar built-in elements (42), and the coarse filter protrusions (73) protruding perpendicular to the bottom plate (5).

[0132] List of reference numerals:

[0133] 1 Microstructured nozzle

[0134] 2 Medically active fluid

[0135] 3 Inlets (of the microstructured nozzle)

[0136] 4 Outlets (of the microstructured nozzle)

[0137] 5 Base plate

[0138] 6 Cover plate

[0139] 7 Inlet end (of the base plate)

[0140] 8 Outlet end (of the base plate)

[0141] 9, 10 Opposite side walls (of the base plate)

[0142] 11 Flow channel (of the microstructured nozzle)

[0143] 12 Injection channel

[0144] 20 Main filter area

[0145] 21 Main filter

[0146] 22 Main filter protrusion

[0147] 23 Rows of main filter protrusions

[0148] 24 Main filter channels

[0149] 25 Peaks (of the main filter)

[0150] 30 Filtrate outlet area

[0151] 40 Fluid distribution area

[0152] 41 Second - level structure (of the fluid distribution area)

[0153] 42 Cylindrical built - in element (of the second - level structure)

[0154] 43 Rows of built - in elements

[0155] 44 Channels of the second - level structure

[0156] 50 First interface area

[0157] 60 Second interface area

[0158] 70 Coarse filter area

[0159] 71 Coarse filter

[0160] 72 Coarse filter protrusion

[0161] 73 Coarse filter channels

[0162] 100 Suction device

[0163] 110 Suction device unit

[0164] 111 housing

[0165] 112 lower part of the housing

[0166] 113 receiving unit

[0167] 114 connecting unit

[0168] 120 exchangeable reservoir

[0169] 130 pumping unit

[0170] 131 upstream end of the pumping unit

[0171] 132 downstream end of the pumping unit

[0172] 133 riser pipe

[0173] 134 upstream end of the riser pipe

[0174] 135 hollow cylinder

[0175] 136 lockable device

[0176] X flow direction

Claims

1. A microstructured nozzle (1) of a device (100) for generating an inhalable aerosol of a medically active fluid (2), the microstructured nozzle (1) having a main filter (21), an inlet (3) for the unfiltered fluid (2) and an outlet (4) for the filtered fluid (2), the inlet (3) and the outlet (4) defining a flow direction (X) of the fluid (2) from the inlet (3) to the outlet (4), the nozzle (1) comprising: - A substantially flat bottom plate (5) and a cover plate (6) attachable to the bottom plate; - A main filter area (20), including a main filter (21) configured as a primary structure, having a plurality of main filter protrusions (22) arranged side by side in at least one row (23), each main filter protrusion (22) being formed as a component of the bottom plate (5) and protruding from the bottom plate (5), the main filter protrusions (22) being spaced from each other by main filter channels (24) which form a path for the fluid (2) through the nozzle (1) from the inlet (2) to the outlet (3), while the cover plate (6), if attached to the bottom plate (5), covers the main filter protrusions (22) and the main filter channels (24); - A filtrate outlet area (30), arranged in the flow direction (X) between the main filter (21) and the outlet (4); and - A fluid distribution area (40), arranged in the flow direction (X) between the inlet (3) and the main filter area (20), wherein a secondary structure (41) is configured in the fluid distribution area (40), the secondary structure including a plurality of cylindrical built-in elements (42) extending transversely to the flow direction from the bottom plate (5) and / or the cover plate (6).

2. The microstructured nozzle (1) according to claim 1, wherein, The main filter (21) includes a plurality of zigzag protrusions (22) extending transversely to the flow direction from the bottom plate (5), defining a plurality of channels (24) and forming peaks (25) in the direction of the inlet (3) and the outlet (4).

3. The microstructured nozzle (1) according to claim 1 or 2, wherein, All the cylindrical built-in elements (42) of the secondary structure provided in the microstructured nozzle (1) are configured in the fluid distribution area (40).

4. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The cylindrical built-in elements (42) of the secondary structure are evenly and regularly distributed throughout the fluid distribution area.

5. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The filtrate outlet area (30) does not include structural elements located within the internal volume of the filtrate outlet area (30).

6. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The filtrate outlet area (30) has the same width as the main filter area (20) (downstream end), and optionally tapers gradually or discontinuously in the direction towards the outlet end (4) of the microstructured nozzle (1).

7. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The inlet (3) is located at the inlet end (7) of the base plate (5), and the outlet (4) is located at the opposite outlet end (8) of the base plate (5), and wherein the inlet (3) and the outlet (4) are connected by opposite side walls (9, 10), the inlet (3) and the outlet (4) defining a flow channel (11) through which the pharmaceutically active fluid (2) flows in a flow direction (X), wherein the outlet (4) includes at least one injection channel (12) for injecting a jet of the pharmaceutically active fluid (2).

8. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The outlet (4) includes at least two injection channels (12) adapted to inject at least two jets of the pharmaceutically active fluid (2) such that the at least two jets intersect each other to form the inhalable aerosol.

9. The microstructured nozzle (1) according to any one of the preceding claims, wherein, One or more spacings between the built-in elements (42) of the second-stage structure result in a cross-sectional area effective for permeation of the liquid (2) transverse to the flow direction that is greater than the corresponding effective cross-sectional area of the main filter channels (24) formed by the protrusions (22) of the main filter (21), such that the built-in elements (42) substantially do not increase the flow resistance, and each such spacing forms a flow-through channel (44) for the liquid (2) to pass through.

10. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The built-in elements (42) of the fluid distribution zone have a cylindrical peripheral wall.

11. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The spacing between the built-in elements (42) is from about 0.005 mm to about 0.02 mm.

12. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The diameter of the built-in elements (42) is from about 0.005 mm to about 0.02 mm.

13. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The cylindrical built-in elements (42) extend from the base plate (5) to the cover plate (6).

14. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The protrusions (22) of the main filter (21) are arranged side by side over the entire width of the main filter (21).

15. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The built-in elements (42) are formed as an integral part of the base plate (5).

16. The microstructured nozzle (1) according to any one of the preceding claims, wherein, All the main filter protrusions (22) and all the built-in elements (42) are formed as an integral part of the base plate (5).

17. The microstructured nozzle (1) according to any one of the preceding claims, wherein, A plurality of cylindrical built-in elements (42) are arranged in a plurality of parallel rows (43) that are arranged transverse to the flow direction.

18. The microstructured nozzle (1) according to any one of the preceding claims, wherein, A plurality of cylindrical built-in elements (42) are arranged in about 40 to about 70 parallel rows (43) per mm (relative to the length of the second-stage structure in the flow direction), preferably about 50 to 60 parallel rows per mm, and the rows extend from one side wall (9) to the opposite side wall (10).

19. The microstructured nozzle (1) according to any one of the preceding claims, wherein, Perpendicular to the flow direction and extending from one side wall (9) to the opposite side wall (10), a plurality of cylindrical built-in elements (42) are arranged in about 10 to about 30 parallel rows (43), preferably about 15 to about 25 parallel rows.

20. The microstructured nozzle (1) according to any one of the preceding claims, wherein, Each row (43) of the cylindrical built-in elements (42) of the second-stage structure (41) includes about 40 to about 60 built-in elements (42) per mm, preferably from about 45 to about 55 built-in elements per mm.

21. The microstructured nozzle (1) according to any one of the preceding claims, wherein, Each row (43) of the cylindrical built-in elements (42) of the second-stage structure (41) includes about 80 to about 120 built-in elements (42), preferably from about 90 to about 110 built-in elements.

22. The microstructured nozzle (1) according to any one of the preceding claims, wherein, At least some of the built-in elements (42) form an equilateral hexagonal design, with the center of each hexagonal design formed by a built-in element (42), and each corner of each hexagonal design formed by an adjacent built-in element (42).

23. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The built-in components (42) are arranged in the fluid distribution area (40) in a number of about 200,000 to about 300,000 per cm 2 or so.

24. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The fluid distribution area (40) does not overlap with the main filter area (20).

25. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The built-in elements (42) of the secondary structure (41) of the fluid distribution area (40) do not contact the main filter area (20).

26. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The width of the fluid distribution area (40), in particular the width of the array of cylindrical boundary elements (42) provided in the fluid distribution area (40), is constant or substantially constant over the entire length of the fluid distribution area (40).

27. The microstructured nozzle (1) according to any one of the preceding claims, comprising a first interface area (50) located between the fluid distribution area (40) and the main filter area (20) in the flow direction, wherein the first interface area (50) does not include structural elements located within the first interface area (50).

28. The microstructured nozzle (1) according to any one of the preceding claims, comprising a second interface area (60) located between the inlet (3) and the fluid distribution area (40) in the flow direction, wherein the second interface area (60) does not include structural elements located within the second interface area (60).

29. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The microstructured nozzle (1) at least comprises an inlet (3), an outlet (4), and, in the flow direction between the inlet (3) and the outlet (4): - A fluid distribution area (40) comprising a secondary structure of cylindrical built-in elements (42) downstream of the inlet (3), - A first interface area (50) located downstream of the fluid distribution area (40), - A main filter area (20) comprising a main filter (21) as a primary structure downstream of the first interface area (50), and - A filtrate outlet area (30) located downstream of the main filter area (20).

30. The microstructured nozzle (1) according to any one of the preceding claims, comprising a coarse filter area (70) located between the inlet (3) and the fluid distribution area (40) or between the inlet and the second interface area (60), the coarse filter area (70) comprising a coarse filter (71) configured as a tertiary structure, the coarse filter having a plurality of coarse filter protrusions (72) arranged side by side in at least one row, each of the coarse filter protrusions being formed as a part of the bottom plate (5) and protruding from the bottom plate (5), the protrusions (72) being spaced apart from each other by coarse filter channels (73), the coarse filter channels forming a path for fluid to pass through the nozzle (1) from the inlet (3) to the outlet (4), and the cover plate (6), if attached to the bottom plate (5), covering the coarse filter protrusions (72) and the coarse filter channels (73).

31. The microstructured nozzle (1) according to any one of the preceding claims, wherein, The microstructured nozzle (1) at least comprises an inlet (3), an outlet (4), and, in the flow direction between the inlet (3) and the outlet (4): - A coarse filter area (70) downstream of the inlet (3), including a coarse filter (71) as a third-stage structure, - A second interface area (60) downstream of the coarse filter area (70), - A fluid distribution area (40) downstream of the second interface area (60), including a second-stage structure of a cylindrical built-in element (42), - A first interface area (50) downstream of the fluid distribution area (40), - A main filter area (20) downstream of the first interface area (50), including a main filter (21) as a primary structure, and - A filtrate outlet area (30) downstream of the main filter area (20).

32. An inhalation device (100) for inhalation therapy, comprising the microstructured nozzle (1) according to any one of claims 1 to 31.

33. The inhalation device (100) according to claim 32, wherein, The inhalation device (100) is a hand-held inhalation device.

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