Microstructured Nozzle

Abstract

The present invention provides a microstructured nozzle (1) for a device (100) intended for generating an inhalable aerosol of a medically active fluid (2), the microstructured nozzle (1) having a primary filter (21), an inlet (3) for unfiltered fluid, and an outlet (4) for filtered fluid, the inlet and outlet defining a fluid flow direction (X) from the inlet to the outlet, the nozzle comprising a substantially flat base plate (5) and a cover plate (6) attachable thereto, a primary filter region (20) including the primary filter (21), a filtrate outlet region (30) disposed in the flow direction between the primary filter and the outlet, and a fluid distribution region (40) disposed in the flow direction between the inlet and the primary filter region, wherein a secondary structure (41) is disposed in the fluid distribution region, the secondary structure comprising a plurality of columnar built-in elements (42) extending transversely from the base plate and / or cover plate to the flow direction. The present invention further provides an inhalation device (100) for inhalation therapy comprising such a microstructured nozzle.

Description

[Technical Field]

[0001] The present invention relates to the field of inhalation devices for medically active fluids. In particular, the present invention relates to a microstructured nozzle for a device intended for generating inhalable aerosols of medically active fluids, as well as to an inhalation device comprising such a microstructured nozzle. [Background technology]

[0002] Nebulizers or other aerosol generators for liquids have been known in the art for many years. Such devices are used, inter alia, in medicine and therapy. In these fields, they function as inhalation devices for administering active ingredients in the form of aerosols, i.e., small droplets contained in a gas. Such an inhalation device is known, for example, from EP 0 627 230 B1. The essential components of this inhalation device are a reservoir containing the liquid to be aerosolized, a pump device for generating a pressure high enough to atomize the liquid, and an atomizing device in the form of a nozzle. The pump device draws the liquid from the reservoir in discrete, i.e., non-continuous, amounts and supplies it to the nozzle. The pump device operates without a propellant and generates pressure mechanically.

[0003] To obtain a sufficiently homogeneous and fine droplet mist, relatively high pressures are usually required, such as 10 bar up to about 300 bar. To keep the amount of vaporized liquid in each dose acceptably low, atomizing nozzles usually contain one or several channels, each a few μm in diameter. 2 (square micrometer) order, e.g., 2 μm 2 ~200μm 2 The channel is present in the nozzle body and is often fabricated using micro-technical fabrication techniques such as micro-etching, micro-lithography, and the like.

[0004] A specific example of a nozzle implemented in a particular nebulizer is disclosed in U.S. Patent Application Publication No. 2005 / 0001076. The disclosed microstructured nozzle consists of several channels created by microstructuring a plate-like member. In the nozzle, the channels are arranged in a row and are located between protrusions extending from a base plate. The microstructured base plate is covered by a cover plate. The channels are precisely defined in terms of shape, cross-sectional area, and length. The disclosed nozzle contains a zigzag-shaped filter as a primary structure and a secondary structure downstream of the filter.

[0005] Due to the plate-like configuration of the disclosed microstructured nozzles having an inlet slot for the inflow of pressurized fluid, it has proven difficult to provide a uniform flow of pressurized fluid to be atomized across the entire width of the inlet slot, especially considering the fact that the pressurized liquid to be atomized is usually supplied by a circular tube or other connection to a pump or pressure generator, which results in an uneven distribution of the pressurized liquid within the nozzle which may particularly affect the contact of the fluid with the filter element, which may be zigzag shaped or have another configuration.

[0006] It is therefore an object of the present invention to provide an improved microstructured nozzle that provides a more uniform distribution of pressurized fluid atomized within the nozzle structure, particularly with respect to a filter structure provided in such a microstructured nozzle. Further objects of the present invention will become apparent based on the following description of the invention, examples and claims. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] European Patent No. 0627230 [Patent Document 2] US Patent Application Publication No. 2005 / 0001076 Summary of the Invention

[0008] In a first aspect, the present invention relates to a microstructured nozzle (1) for a device (100) intended for the generation of 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 to the outlet defining a direction (X) of fluid flow from the inlet to the outlet, the nozzle comprising: a substantially flat base plate (5) and a cover plate (6) that can be attached thereto; a main filter area (20) including a primary constructed main filter (21) having a plurality of main filter projections (22) arranged side by side in at least one row (23), each main filter projection being formed as an integral component of and projecting from a base plate, the main filter projections being spaced apart by main filter channels (24) forming a path for fluid through the nozzle from the inlet to the outlet, and a cover plate covering the main filter projections and the main filter channels when attached to the base plate; a filtrate outlet area (30) arranged in the direction of flow between the main filter and the outlet, and a fluid distribution area (40) arranged in the direction of flow between the inlet and the main filter area; Equipped with The fluid distribution region has a secondary structure (41) disposed therein that comprises a plurality of columnar embedded elements (42) extending transversely to the flow direction from the base plate and / or cover plate.

[0009] In a second aspect, the present invention provides an inhalation device for inhalation therapy comprising a microstructured nozzle according to the first aspect of the invention. [Brief explanation of the drawings]

[0010] [Figure 1] 1 shows a cross-sectional view of an exemplary inhalation device (100) comprising a microfluidic nozzle (1). [Figure 2]1 shows one embodiment of the base plate (5) of the microfluidic nozzle (1) of the present invention viewed from the side, initially in an open state, which may then be covered with a cover plate (6) (not shown). [Figure 3] An enlarged top view of a portion of a secondary structural post-shaped embedded element (42) is shown as it appears in cross section in a fluid distribution area (40). [Figure 4] 1 shows an enlarged top view of a cross section of the main filter (21). [Figure 5A] Figure 1 shows a perspective view of a microstructured nozzle (1) according to the invention, comprising a base plate (5) and a cover plate (6) attached to each other. [Figure 5B] Figure 1 shows a perspective view of a microstructured nozzle (1) according to the invention, comprising a base plate (5) and a cover plate (6) attached to each other. [Figure 6] FIG. 3 shows a perspective view of a cross section of the base plate (5) of the microstructure nozzle (1) shown in the top view of FIG. 2. DETAILED DESCRIPTION OF THE INVENTION

[0011] The following terms or expressions used herein should generally be interpreted as outlined in this section, unless otherwise defined by the specification or unless the particular context indicates or requires otherwise.

[0012] The terms "comprise," "comprises," and "comprising," and similar expressions, are to be interpreted in an open and inclusive sense in the present specification and claims, such as "including, but not limited to." In contrast, the terms "consist of," "consists of," and "consisting of," as used herein, are closed words, meaning that only the referenced elements are present.

[0013] The terms "a" or "an" should be understood to refer to the plural, i.e., the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates or requires otherwise. In other words, all references in this disclosure to singular features or limitations shall include the corresponding plural features or limitations, and vice versa, unless expressly specified otherwise or clearly implied otherwise by the context in which the reference is made. Thus, the terms "a," "an," and "the" have the same meaning as "at least one" or "one or more," unless otherwise defined.

[0014] The phrases "one embodiment," "an embodiment," "particular embodiment," and the like mean that the particular feature, characteristic, or characteristic, or particular group or combination of features, characteristics, or characteristics, referenced in connection with the respective phrase, is present in at least one embodiment of the invention. The appearances of these phrases in various places throughout this specification do not necessarily refer to the same embodiment. Furthermore, the particular features, characteristics, or characteristics may be combined in any suitable manner in one or more embodiments.

[0015] Terms such as "essentially," "about," "approximately," "substantially," and the like, in connection with an attribute or value, include the exact attribute or exact value, as well as any attribute or value that would normally be considered to be within the normal range or variability accepted in the relevant technical field. For example, the term "about," as used herein in connection with a value or range of values, is intended to mean that such value or range of values ​​includes a typical deviation from such value of up to + / -5% (absolute value), or up to + / -4%, or up to + / -3%, or up to + / -2%, or up to + / -1%, or up to + / -0.5%.

[0016] According to a first aspect, the present invention provides a microstructured nozzle (1) for a device (100) intended for the generation of 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 to the outlet defining a direction (X) of fluid flow from the inlet to the outlet, the nozzle comprising: a substantially flat base plate (5) and a cover plate (6) that can be attached thereto; a main filter area (20) including a primary constructed main filter (21) having a plurality of main filter projections (22) arranged side by side in at least one row (23), each main filter projection being formed as an integral component of and projecting from a base plate, the main filter projections being spaced apart by main filter channels (24) forming a path for fluid through the nozzle from the inlet to the outlet, and a cover plate covering the main filter projections and the main filter channels when attached to the base plate; a filtrate outlet area (30) arranged in the direction of flow between the main filter and the outlet, and a fluid distribution area (40) arranged in the direction of flow between the inlet and the main filter area (for distribution of unfiltered fluid before contact with the main filter); Equipped with The fluid distribution region has a secondary structure (41) disposed therein that comprises a plurality of columnar embedded elements (42) extending transversely to the flow direction from the base plate and / or cover plate.

[0017] The present invention provides a microstructured nozzle for a device intended to generate an inhalable aerosol of a medically active fluid. Such inhalation devices, or nebulizers, intended to generate an inhalable aerosol of a medically active fluid are described in the prior art, for example, in the aforementioned U.S. Patent Application Publication No. 2005 / 0001076 and the references cited therein. Another inhalation device is disclosed in WO 2018 / 197730, the entire contents of which are incorporated herein by reference. These inhalation devices are typically small enough to be held in one hand and operated by a user. They typically comprise a reservoir for holding the medically active fluid to be aerosolized and administered, a pump unit for pressurizing the medically active fluid, an actuation mechanism, and a nozzle unit through which the medically active fluid pressurized by the pump unit is aerosolized, or in other words, atomized. According to the present invention, such a nozzle unit may comprise a microstructured nozzle, as described in more detail below.

[0018] The microstructured nozzles according to the present invention are suitable for generating inhalable aerosols of medically active fluids, the term "medically active fluid" as used herein refers to a pharmaceutically acceptable liquid compound or composition, particularly a liquid compound or composition that has or is pharmacologically active and is capable of ameliorating or preventing the associated symptoms of a disease, disorder, or condition, particularly a disease, disorder, or condition of the respiratory system, such as a lung disease, lung disorder, or pulmonary condition, in a subject, particularly a warm-blooded animal or a human, particularly a human. Specific examples of such diseases, disorders, or conditions include, but are not limited to, pulmonary diseases or conditions such as asthma and / or chronic obstructive pulmonary disease (COPD), particularly COPD, or interstitial lung diseases affecting the interstitium of the lungs and lung tissue, such as those associated with the airways and / or air sacs (surface sacs), e.g., pulmonary fibrosis such as idiopathic pulmonary fibrosis (IPF), interstitial pneumonia, or sarcoidosis.

[0019] Furthermore, the term "inhalable aerosol" refers to an aerosol having respirable particles or droplets, preferably such particles or droplets having a mass median aerodynamic diameter (measured by laser diffraction) of about 10 μm or less, particularly about 7 μm or less, or about 5 μm or less, respectively.

[0020] In certain embodiments, the term "medically active fluid" as used herein refers to a medically active fluid or liquid in the form of a pharmaceutical composition comprising at least one active pharmaceutical ingredient (API), more particularly at least one inhalable API. More particularly, such at least one inhalable API may be selected, for example, from inhaled long-acting muscarinic antagonists (LAMAs), long-acting beta agonists (LABAs), and inhalable glucocorticosteroids (ICSs), as well as anti-inflammatory and anti-diabetic agents, either alone or in combination with one another.

[0021] Examples of long-acting inhaled anticholinergics (LAMAs) include, but are not limited to, aclidinium bromide, glycopyrronium salts such as glycopyrronium bromide, lebefenacin, tiotropium such as tiotropium bromide, umeclidinium bromide, oxitropium bromide, flutropium bromide, ipratropium bromide, tropium chloride, and tolterodine.

[0022] Examples of long-acting beta-agonists (LABAs) include, but are not limited to, albuterol, alloformoterol, bambuterol, bitolterol, broxaterol, carbuterol, clenbuterol, fenoterol, formoterol, hexoprenaline, ibuterol, indacaterol, indacterol, isoetharine, isoprenaline, levosalbutamol, mabuterol, melaudrine, metaproterenol, olodaterol, orciprenaline, pirbuterol, procaterol, reproterol, rimiterol, ritodrine, salmeterol, salmefamol, soterenoto, sulfonterol, tialamide, terbutaline, and terbuterol.

[0023] Examples of inhalable glucocorticosteroids (ICS) include, but are not limited to, prednisolone, prednisone, butixocort propionate, flunisolide, beclomethasone, triamcinolone, budesonide, fluticasone, mometasone, ciclesonide, rofleponide, dexamethasone, etiprednisolone dichloroacetate, deflazacort, etiprednol, loteprednol, RPR-106541, NS-126, and ST-26.

[0024] Furthermore, the drug substance may be selected from an opioid anti-inflammatory analgesic (e.g., morphine, fentanyl) or a non-opioid anti-inflammatory analgesic (e.g., salicylic acid derivatives, such as acetylsalicylic acid derivatives), or a cannabinoid (e.g., tetrahydrocannabinol), or an antidiabetic drug, or insulin.

[0025] The medically active fluid that can be atomized or aerosolized by the microstructured nozzles of the present invention can include at least one pharmaceutically active ingredient as described above, but can also include a mixture of two or more pharmaceutically active ingredients that can be administered by inhalation.

[0026] The medically active fluids referred to herein may be in the form of dispersions, e.g., suspensions comprising a liquid continuous phase and a solid dispersed phase, and solutions, particularly aqueous solutions. Furthermore, the medically active fluids referred to herein may optionally contain one or more physiologically acceptable excipients suitable for inhalation use. Excipients that may characterize the medically active fluids referred to herein may include, but are not limited to, one or more of the following: buffers for adjusting or controlling the pH of the solution, salts, flavoring agents, surfactants, lipids, antioxidants, preservatives, and cosolvents (which may be used to increase or improve solubility), such as water, alcohols, particularly alcohols having 2 to 4, or preferably 2 or 3, carbon atoms, e.g., ethanol, propanol, or isopropanol, or glycols, e.g., propylene. In certain embodiments, the medically active fluids may be essentially free of, or even free of, propellants, such as hydrofluoroalkanes (HFAs).

[0027] In certain embodiments, the medically active fluid referred to herein comprises at least one pharmaceutically active ingredient as described above dissolved in an alcoholic or aqueous liquid vehicle or solvent. In preferred embodiments, such liquid vehicle or solvent comprises water and / or ethanol, preferably ethanol. In even more specific embodiments, such liquid vehicle or solvent comprises, or preferably consists of, ethanol or a mixture of ethanol and water, where ethanol may be present in an amount, for example, at least about 50% by weight, or at least about 60% by weight, or at least about 70% by weight or even more, and water may be present in a corresponding amount, up to about 50% by weight, or up to about 40% by weight, or up to about 30% by weight or less. In certain embodiments, the liquid vehicle or solvent comprises or consists of ethanol in an amount of about 60 to about 80% by weight, e.g., about 70% by weight, and water in an amount of about 40 to about 20% by weight, e.g., about 30% by weight. In more particular embodiments, the liquid vehicle or solvent may comprise, essentially comprise, or consist of, for example, water in an amount of about 80% by weight or about 90% by weight to about 100% by weight (based on the total weight of the liquid vehicle), e.g., about 85% by weight, or about 90% by weight, or about 95% by weight, or even about 97% by weight to about 98% by weight, or about 99% by weight, or about 99.5% by weight, and an additional solvent, or a mixture of additional solvents, preferably an alcohol or glycol, specifically ethanol, added up to 100% by weight of the liquid vehicle.

[0028] In accordance with the present invention, the microstructured nozzle has a filter, an inlet for the entry of unfiltered fluid, and an outlet for the delivery and atomization of filtered fluid. The inlet and outlet of the microstructured nozzle define the direction of fluid flow from the inlet to the outlet, which in turn defines the direction in which the medically active liquid is delivered downstream.

[0029] The dimensions of the microstructured nozzles of the present invention are typically very limited to allow implementation in a sprayer or inhaler device that is particularly portable and suitable for operation with one or both hands of a user. In many cases, the microstructured nozzles of the present invention have a small size, with a diameter and / or edge length much less than 10 mm, or even much less than 5 mm, as described in more detail below. Accordingly, the microstructures provided in the microstructured nozzles, as described in more detail below, typically have dimensions that are one or more orders of magnitude smaller than that.

[0030] According to the present invention, a microstructured nozzle comprises a substantially flat base plate and a cover plate that can be attached to the base plate. The base plate is preferably structured by etching techniques in a manner known to those skilled in the art, e.g., AA Ayon et al. 2001 Smart Mater. Struct., 10, 1135. In some embodiments, the base plate has a generally square or rectangular plate shape with an edge length of up to about 5 mm, e.g., about 0.5 to about 4 mm, or about 1 mm to about 4 mm, or about 1.5 mm to about 3 mm, or about 2 to 3 mm. In some embodiments, the base plate has a width (perpendicular to the flow direction) of about 1.5 mm or about 2 mm to about 3 mm, e.g., about 2.5 mm, and a length (along the flow direction) of about 1.5 mm to about 2.5 mm, e.g., about 2 mm. The height of the base plate is typically in the range of about 0.2 mm to about 2 mm, e.g., 0.6 mm to about 1.2 mm, or about 0.9 mm to about 1.8 mm, or about 1.2 mm to about 1.5 mm. The height of the microstructures (primary, secondary, and tertiary structures) described in more detail below is, in some embodiments, selected within the range of about 2 μm to about 40 μm (measured based on such microstructures on the base plate), typically about 3 μm to about 20 μm, preferably about 4 microns to about 14 microns, particularly about 5 μm to about 8 μm, or even about 5 μm to about 7 μm. When the cover plate does not include any microstructures, i.e., in other words, is provided in the form of a flat cover, the height of such microstructures as referred to above corresponds to the height of the channels provided in the microstructure nozzles. Due to available manufacturing methods, in certain embodiments, the heights (measured from the surface of the base plate in the direction of the cover plate) of all microstructures (including primary structures, secondary structures, and tertiary structures as described in detail below) provided on the base plate are, in some embodiments, the same or substantially the same.

[0031] A material that can be used for the base plate is preferably single crystal silicon, as it is inexpensive, available in a sufficiently flat and parallel state with little surface roughness (i.e., within a wafer), and can be attached to the cover plate without the need for additional adhesive or other materials during the subsequent connection process. To fabricate multiple nozzle arrangements in a parallel fashion, multiple structured base plates can be fabricated from a silicon wafer.

[0032] The microstructured nozzle of the present invention consists of at least two sheets, preferably two sheets of glass and / or silicon, firmly fixed together, at least one of which has one or more microstructured channels connecting the nozzle inlet to the nozzle outlet. The nozzle outlet with an outlet opening, i.e., in other words, the microstructured nozzle's discharge channel, is preferably located on the opposite side of the nozzle inlet. The nozzle inlet can have only one fluid inlet or multiple fluid inlets. After passing through the inlet and any coarse filter, the fluid flows through a filtrate distribution area, as described in detail below, followed by a main filter formed by multiple main filter protrusions. Behind the main filter, i.e., in the direction of flow ("downstream"), between the main filter and the microstructured nozzle's outlet, is a filtrate collection chamber for the already filtered fluid. From the fluid collection chamber, the fluid proceeds to an outlet with one or more, preferably two, discharge channels, preferably manufactured in the form of a nozzle opening.

[0033] The microstructured nozzle of the present invention further includes a cover plate corresponding to the second of the at least two sheets. Suitable cover plates may be sheets of glass, such as alkali borosilicate glass, e.g., Pyrex (Corning) or Tempax (Schott). These may be attached to the base plate, for example, by anodic bonding of silicon and glass.

[0034] In some embodiments, the inlet of the microstructured nozzle of the present invention may be located at the inlet end of the base plate and the outlet may be located at the opposite outlet end of the base plate, the inlet and outlet being connected by opposite sidewalls, and the inlet and outlet may define a flow path through which the medically active fluid flows in the direction of flow (X), i.e., in the downstream direction. In some embodiments, the outlet comprises at least one ejection channel for ejection of a jet of the medically active fluid. In other embodiments, the outlet comprises at least two ejection channels adapted to eject at least two jets of the medically active fluid. In still further embodiments, these at least two liquid jets intersect or collide with each other to form an inhalable aerosol of the medically active fluid. In still further embodiments, the one or more ejection channels may each have a cross-section having a width of about 5 μm to about 15 μm, or about 6 μm to about 10 μm, e.g., about 8 μm, and a height of about 2 μm to about 40 μm, typically about 3 μm to about 20 μm, preferably about 4 to about 14 microns, particularly about 5 μm to about 8 μm, or even about 5 μm to about 7 μm, corresponding to the height of the primary, secondary, and tertiary microstructures described in detail below.

[0035] The microstructured nozzle according to the present invention includes a main filter region that includes a primary filter fabricated as a primary structure. The main filter is disposed in the main filter region of the microstructured nozzle of the present invention and may be formed on the base plate and / or cover plate, preferably, however, only on the base plate. In a preferred embodiment, the main filter is disposed in and formed on the main filter region of the base plate, as described in more detail below. As used herein, the term "region," which is connected to the main filter region but also to further regions, such as the filtrate outlet region, the fluid distribution region, and the first and second boundary regions, as described in more detail below, refers to a specific part or section of the microstructured nozzle of the present invention, specifically a specific section of the surface of the microstructured nozzle of the present invention, and more specifically a specific surface section that forms the flow path of the microstructured nozzle of the present invention. More specifically, the term "region" can refer to a section of the surface of the base plate that forms the flow path, i.e., faces the flow path. Even more specifically, the term "region" can refer to a section of the surface of the base plate that forms the flow path of the microstructured nozzle of the present invention, i.e., faces the flow path, having an essentially rectangular or square shape, preferably an essentially rectangular shape. In some embodiments, such a rectangular or square, preferably rectangular, section of the flow path may have a width spanning the entire flow path from one sidewall to the opposing sidewall, and a length spanning a portion of the entire length of the flow path connecting the inlet and outlet of the microstructured nozzle of the present invention. The primary filter includes a plurality of primary filter protrusions arranged in at least one row, while each primary filter protrusion may form an integral component of and protrude from the base plate. Furthermore, the primary filter protrusions are spaced apart from one another by a primary filter channel that forms a pathway for fluid through the nozzle from the inlet to the outlet, while the cover plate, when attached to the base plate, covers the primary filter protrusions and the primary filter channel.

[0036] In some embodiments, the main filter protrusion (and thus the main filter region) extends across the entire width of the flow channel from one opposing sidewall to the other opposing sidewall. The term "width," as used herein in reference to 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 direction of flow, e.g., in the case of a base plate of the present invention, from one sidewall to the opposing sidewall perpendicular to the direction of flow. In contrast, the term "length," as used herein in reference to a particular structure having such a length, refers to the extension of such a structure in the plane of the flow channel in the direction of flow, e.g., in the case of a base plate of the present invention, from the inlet to the outlet. Finally, the term "height," as used herein in reference to a particular structure having such a height, refers to the extension of such a structure perpendicular to the width, as well as perpendicular to the length of such a structure.

[0037] In some embodiments, the primary filter region can have a width (perpendicular to the direction of flow) of up to about 5 mm, e.g., about 0.5 to about 4 mm, or about 1 to about 4 mm, or about 1.5 to about 2.5 mm, or about 2 to 3 mm, and a length (in the direction of flow) of about 0.5 to about 1.5 mm, or about 0.75 to about 1.25 mm. In some embodiments, the primary filter region can have a constant width throughout its entire length, or in other words, from the upstream end or inlet of the primary filter region to the downstream end or outlet of the primary filter region.

[0038] In certain embodiments, in a microstructure nozzle according to this aspect of the invention, the primary filter includes a plurality of zigzag protrusions extending transversely to the flow direction from the base plate, defining a plurality of channels and forming spikes in the inlet and outlet directions. In even more specific embodiments, the protrusions of the primary filter are arranged side by side across the entire width of the filter, or in other words, from one side wall of the base plate to the opposing side wall of the base plate. Thus, in some embodiments, the primary filter includes a plurality of zigzag protrusions extending transversely to the flow direction that extend across the entire width of the flow passage from one side wall of the base plate to the opposing side wall of the base plate.

[0039] As described above, the primary filter includes a plurality of protrusions arranged in a row, preferably in a zigzag configuration, protruding from a preferably flat base plate and thereby forming an integral part of the base plate. The base plate may be completely covered by a preferably flat cover plate, which forms a plurality of channels between the protrusions and the base plate and the cover plate. These channels form a passageway from the inlet end to the outlet end of the filter nozzle. The spacing between the base plate in the area around the primary filter protrusions and the cover plate within the 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. Unfiltered fluid enters the primary filter through an inlet, which may be in the form of one or more elongated inlet slots. The one or more inlet slots may be approximately the same height as the protrusions protruding from the base plate on the inlet side of the filter.

[0040] In alternative embodiments, the protrusions of the main filter may be arranged in several cascading rows. The protrusions located closer to the inlet side of the filter may be larger than the protrusions located more frequently on the outlet side of the filter. Again, the spacing between the flat base plate and the flat cover plate in the region around each cascading row of main filter protrusions may be approximately the same as the width of the channel on the side of the protrusion where the fluid enters the row of channels. This spacing may be between half and twice the width of the channel. This spacing may decrease from row to row when viewed in the direction of flow. The main filter channel may thus have a substantially square cross-section at the inlet end. In all embodiments, the spacing between the flat base plate in the region around the protrusions and the flat cover plate within the row of main filter protrusions may be constant. The spacing may be larger in the region of the end of the row closer to the outlet side of the main filter than in the region of the end of the row closer to the inlet side of the filter. This spacing preferably increases substantially linearly from one end of the row of protrusions to the other.

[0041] In some embodiments, the spacing between adjacent primary filter projections, and therefore the width of the primary filter channel, can be selected within the range of about 1 μm to about 25 μm, or about 1.5 μm to about 15 μm, or about 2 μm to about 10 μm. In preferred embodiments, the spacing between adjacent primary filter projections is selected from about 2 μm to about 5 μm. In some embodiments, adjacent primary filter elements are equally spaced so that all of the primary filter channels have equal widths.

[0042] The microstructured nozzle of the present invention further comprises a filtrate outlet region disposed in the direction of flow between the main filter (or main filter region) and the outlet of the microstructured nozzle (downstream of the main filter region).

[0043] In certain embodiments, the filtrate outlet region is a region formed on the base plate and / or cover plate, preferably, but only on the base plate, that includes a hollow space that receives filtrate (i.e., filtered medically active fluid) after it has passed through the primary filter, i.e., after it has left the primary filter region. In some embodiments, the filtrate outlet region extends across the entire width of the flow path from one opposing sidewall to the other, and thus may have a width ranging from about 5 mm to about 5 mm, e.g., 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. The length of the filtrate outlet region (in the direction of flow) may be 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. While the width of the filtrate outlet region can vary within wide limits, e.g., as described above, in more specific embodiments, the filtrate outlet region has (approximately) the same width as the primary filter region located upstream of the filtrate outlet region, or in other embodiments, the same width as the downstream end of the primary filter region located upstream of the filtrate outlet region. In even more specific embodiments, the upstream end of the filtrate outlet region has (approximately) the same width as the (downstream end of) the primary filter region located upstream of the filtrate outlet region.

[0044] In more specific embodiments, the filtrate outlet region does not include structural elements disposed in the interior volume (of the hollow space) of the filtrate outlet region, such as primary or secondary structures contained in the main filter region and fluid distribution region. In still further embodiments, the filtrate outlet region does not overlap with the main filter region (and consequently, does not overlap with the fluid distribution region disposed upstream of the main filter region). In other words, in preferred embodiments, the filtrate outlet region is a hollow space for receiving filtered medically active fluid, which in some embodiments may have a volume of about 5 to about 10% of the total interior volume of the microstructured nozzle.

[0045] In certain embodiments, the filtrate outlet region may have the same width as the (downstream end of) the main filter region described above, and may narrow gradually or discontinuously in the direction towards the outlet end of the microstructured nozzle, or in more particular embodiments, may open into at least one outlet channel of the microstructured nozzle of the present invention.

[0046] The microstructured nozzle according to this aspect of the invention further comprises a fluid distribution region disposed between the inlet and the main filter region (in the direction of flow), which is particularly suitable for distribution or diffusion of pressurized unfiltered fluid to be atomized / aerosolized prior to contact with the main filter, as described in more detail below.

[0047] In certain embodiments, the fluid distribution region is a region formed on the base plate and / or cover plate, preferably but only on the base plate, that includes a hollow space in which secondary structures are disposed, as described in more detail below. The fluid distribution region, in some embodiments, extends across the entire width of the flow channel from one sidewall to the opposing sidewall, and thus may have a width ranging from about 5 mm to about 5 mm, e.g., 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 about 3 mm, etc. The length of the fluid distribution region (in the direction of flow) may be 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, or from about 0.3 mm to about 0.4 mm. While the width of the fluid distribution region can vary within broad ranges, e.g., as noted above, in more specific embodiments, the fluid distribution region can have (approximately) the same width as the primary filter region located downstream of the fluid distribution region, or in alternative embodiments, the same width as the upstream end of the primary filter region. In some embodiments, the fluid distribution region has an essentially constant or uniform width throughout the entire length of the fluid distribution region. In even more specific embodiments, the fluid distribution region has a height (perpendicular to the width and length) of about 2 μm to about 40 μm, typically about 3 μm to about 20 μm, preferably about 4 to about 14 μm, particularly about 5 μm to about 8 μm, or even about 5 μm to about 7 μm.

[0048] In the fluid distribution region of the microstructure nozzle of the present invention, a secondary structure is disposed transverse to the flow direction, including a plurality of columnar built-in elements extending to the base plate and / or cover plate, preferably extending only from the base plate. To form the secondary structure in the fluid distribution region, additional columnar built-in elements are manufactured. Preferably, these built-in elements of the secondary structure are in the form of cylindrical ridges extending from the bottom of the base plate to the cover plate. 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 microstructure nozzle of the present invention are disposed in the fluid distribution region. Thus, in these embodiments, none of the columnar built-in elements of the secondary structure are disposed in at least one of the main filter region and the filtrate outlet region, and specifically none of the columnar built-in elements of the secondary structure are disposed in the filtrate outlet region.

[0049] In certain embodiments, the height of the built-in element corresponds to the height of the fluid distribution area described above. In further embodiments, the built-in element may be formed external to the base plate or as an integral part of the cover plate. In preferred embodiments, the built-in element is formed as an integral part of the base plate. In yet further embodiments, all of the main filter projections (of the primary structure) and all of the built-in elements (of the secondary structure) are formed as an integral part on the base plate.

[0050] In alternative embodiments, the built-in elements may be formed externally to the base plate and externally to the cover plate. For example, some built-in elements may be formed entirely from the base plate and some built-in elements may be formed entirely from the cover plate. In further alternative embodiments, the built-in elements may be formed partially by the base plate and partially by the cover plate, such that corresponding portions of the built-in elements are bonded to the final built-in element when the cover plate covers the base plate. In a preferred embodiment, the columnar built-in elements extend from the base plate to the cover plate.

[0051] In certain embodiments, the dimensions of the columnar built-in elements of the secondary structure are selected so that they do not substantially increase flow resistance. This can be achieved by creating spaces between the built-in elements, each of which forms a through-flow channel for the passing liquid, so that the resulting cross-sectional area perpendicular to the flow direction that is effectively permeable to the liquid is greater than the corresponding effective cross-sectional area of ​​the through-flow channel formed by the filter structure, more specifically the primary structure of the main filter. Thus, the flow characteristics of the liquid inside the nozzle are most strongly influenced by the (primary) structure of the main filter.

[0052] Thus, in a preferred embodiment, one or more spacings between the columnar built-in elements form a flow-through channel for the liquid passing through each of them, but these are such that the resulting cross-sectional area transverse to the direction of flow that is effectively permeable to the liquid is greater than the corresponding effective cross-sectional area of ​​the main filter channel formed by the protrusions of the main filter, so that the built-in elements do not substantially increase flow resistance.

[0053] The cross section of the built-in elements is preferably selected to minimize the flow resistance of the flowing fluid. For this, round, circular or elliptical cross sections are preferred. As an alternative to the above cross sections, they can also be triangular, trapezoidal or rectangular, while the angles must be aligned with the direction of flow. However, in a preferred embodiment, the built-in elements of the secondary structure of the fluid distribution area have cylindrical peripheral walls. However, as an alternative, it can also be advantageous to construct built-in elements with concave or alternatively convex peripheral walls.

[0054] In a further preferred embodiment, the dimensions, spacing and arrangement of the columnar built-in elements of the secondary structure relative to one another are such that the resulting arrangement of the columnar built-in elements allows the formation of an interface between the medically active liquid and the surrounding atmosphere, particularly on the upstream or downstream end, specifically on the downstream end of the secondary structure, so as to allow the formation of forces caused by the surface tension of the medically active liquid when in contact with the secondary structure.

[0055] In preferred embodiments, the built-in elements of the secondary structure are arranged in parallel rows in an ABAB configuration, with preferably equidistant spacing within and between rows A and B. Adjacent rows A and B are preferably displaced in the direction of flow by the diameter of the built-in element. The use of built-in elements with circular cross-sections can therefore create a pattern (a hexagonal pattern) in which each built-in element forms the center of a regular hexagon, with each angle formed by an adjacent built-in element. In some embodiments, at least some built-in elements form a regular hexagonal pattern, with each center of the hexagonal pattern formed by a built-in element and each angle of each hexagonal pattern formed by an adjacent built-in element.

[0056] Obviously, this only applies to built-in elements that are surrounded by a regular hexagon, and therefore does not apply to built-in elements that are located on the edges, i.e., in other words, adjacent to the upstream or downstream ends of the secondary structure or to opposite side walls of the secondary structure.

[0057] In certain embodiments, the columnar built-in elements of the secondary structure can be spaced from one another at a distance selected from the range of about 5 μm to about 50 μm, or about 5 μm to about 20 μm, or about 5 μm to about 15 μm, or about 7.5 μm to about 12.5 μm, e.g., 10 μm, thereby forming channels of the secondary structure. In even more specific embodiments, the columnar built-in elements of the secondary structure are uniformly and regularly distributed throughout the fluid distribution region. In even more specific embodiments, the spacing between adjacent columnar built-in elements is the same throughout the fluid distribution region. In even further embodiments, the multiple channels of the secondary structure have a constant diameter throughout the height of the secondary structure.

[0058] According to more specific embodiments, the columnar embedded elements have a diameter selected within the range of about 5 μm to about 50 μm, or about 5 μm to about 20 μm, or about 5 μm to about 15 μm, or about 7.5 μm to about 12.5 μm, for example, in the range of 10 μm. In preferred embodiments, the columnar embedded elements of the secondary structure have the same cross-sectional shape, preferably a round cross-sectional shape. In further preferred embodiments, the columnar embedded elements of the secondary structure have the same (cross-sectional) diameter and, in addition, the same height. In further preferred embodiments, as outlined above, the spacing between the columnar embedded elements of the secondary structure must be greater than the minimum spacing of the structures forming the preferably zigzag-shaped filter structure of the primary filter located downstream of the secondary structure in the fluid distribution region.

[0059] In advantageous embodiments, the plurality of columnar embedded elements may be arranged in parallel rows, transverse to the direction of flow, preferably extending from one side wall of the base plate to the opposing side wall. Furthermore, in certain embodiments, the plurality of columnar embedded elements are arranged in parallel rows extending from one side wall to the opposing side wall at a density of about 40 to about 70, preferably about 50 to 60, elements per mm (of the length of the secondary structure in the direction of flow).

[0060] In still further embodiments, the plurality of columnar built-in elements of the secondary structure may be arranged in about 10 to about 30, preferably about 15 to about 25, parallel rows extending perpendicular to the direction of flow from one sidewall to the opposing sidewall. In further embodiments, each row of columnar built-in elements of the secondary structure may contain about 40 to about 60, preferably about 45 to about 55, built-in elements per mm. In certain embodiments, each row of columnar built-in elements of the secondary structure may contain about 80 to about 120, preferably about 90 to about 110, built-in elements per row per mm.

[0061] In these embodiments, particularly when the rows are arranged relative to one another in the ABAB configuration described above, the dense columnar embedded elements may be spaced apart from one another by more than 1 cm (relative to the surface of the fluid distribution area). 2This can be achieved with secondary structures disposed within the fluid distribution area ranging from about 200,000 (two hundred thousand) to about 300,000, or from about 250,000 to about 300,000 embedded elements per cm. Thus, in preferred embodiments, embedded elements are disposed within the fluid distribution area. 2 Approximately 200,000 to 300,000 pieces per 1cm 2 The number of the particles is about 250,000 to about 300,000 per fluid distribution area.

[0062] As already described in detail above, the fluid distribution region is disposed between the medically active fluid inlet and the primary filter region in the direction of flow. In preferred embodiments, however, the fluid distribution region does not overlap with the primary filter region, although in certain embodiments, the fluid distribution region may be adjacent to the primary filter region. In other words, in some embodiments, the downstream end of the fluid distribution region may contact the upstream end of the primary filter region. However, in further embodiments, the columnar built-in elements of the fluid distribution region do not contact the primary filter region, and in particular do not contact the protrusions of the primary structure disposed within the primary filter region.

[0063] The fluid distribution region of the microstructured nozzle of the present invention, or more specifically the secondary structure including the arrangement of post-shaped built-in elements therein, in preferred embodiments allows for a more equal, or in other words, homogeneous distribution of the medically active fluid to be filtered and atomized uniformly across or into a wider segment of the overall width of the primary filter, particularly when the medically active fluid does not enter the inlet of the microstructured nozzle uniformly across the entire width of the fluid channel extending from one sidewall to the opposing sidewall. This is particularly advantageous when pressurized medically active fluid is delivered to the inlet of the microstructured nozzle from a pump unit or other source of pressure by tubing 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 secondary structure of the fluid distribution region at its upstream end (facing the inlet of the microstructure 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, particularly when, according to preferred embodiments of the microstructure nozzle of the present invention, the spacing between the built-in elements of the secondary structure is such that the resulting cross-sectional area across the direction of flow that is effectively permeable to the medically active fluid is greater than the corresponding effective cross-sectional area of ​​the main filter channel formed by the protrusions of the main filter.

[0064] Furthermore, in preferred embodiments, as described in detail above, the secondary structures provided in the fluid distribution region, particularly when provided in the form of parallel rows in an ABAB configuration with preferably equidistant spacing within and between rows A and B, allow the formation of a fluid-gas interface when the medically active fluid to be atomized moves or retreats upstream, i.e., from the main filter region toward the inlet of the microstructured nozzle, preferably at the most downstream row of columnar built-in elements. This may be relevant, for example, when, after ejection and atomization of the pressurized medically active fluid through at least one ejection channel, the pressure acting on the medically active fluid is (partially) relieved or even reversed. Furthermore, this occurs when the medically active fluid remaining in the microstructured nozzle is exposed to negative pressure, i.e., under pressure, for example, under pressure generated by a pump unit comprising a pump chamber and a piston that are mutually movable within, for example, during the priming phase of the pump. In these cases, the secondary structure containing the columnar built-in elements may function as a microfluidic valve that avoids or reduces backflow of the medically active liquid in the upstream direction, following capillary forces acting between the medically active liquid and the array of columnar built-in elements at the fluid-gas interface at the downstream end of the fluid distribution region.

[0065] In a preferred embodiment, the secondary structures disposed within the liquid distribution region are provided in a manner such that the force acting between the medically active fluid and the array of cylindrical built-in elements is defined and, as far as possible, uniform, regardless of the actual location of the boundary line between the medically active fluid and the surrounding atmosphere. When the array of cylindrical built-in elements is provided in the form of equidistant parallel rows, this is particularly true when the boundary line is located in the most downstream row of built-in elements. However, when multiple cylindrical built-in elements with uniform dimensions are uniformly distributed throughout the fluid distribution region, the force acting between the medically active fluid and the cylindrical structures at the boundary line (corresponding to the Laplace pressure of the medically active fluid contacting the multiple cylindrical built-in elements) can be uniform regardless of the actual location of the boundary line (assuming the medically active fluid forms a linear or approximately linear boundary line or meniscus perpendicular to the flow direction between opposite sides of the liquid channel). Thus, in a preferred embodiment as already outlined above, the secondary structure is provided in the form of an array of uniform columnar embedded elements with cylindrical circumferential walls arranged in equidistant parallel rows, preferably in an ABAB configuration, as described in detail above.

[0066] As outlined above, it may be advantageous if the force acting between the medically active fluid and the array of columnar built-in elements is defined, and as uniform as possible, independent of the actual position of the boundary line (corresponding to the fluid-gas interface) between the medically active fluid and the surrounding atmosphere, particularly when the secondary structure of the columnar built-in elements acts as a microfluidic valve or interruption, regulating the backflow of the medically active liquid in the upstream direction as described above. To provide a uniform and defined force acting on the medically active fluid and the array of columnar boundary elements, it may be advantageous when the width of the fluid distribution area, specifically the width of the array of columnar boundary elements provided in the fluid distribution area, is constant or substantially constant over the entire length of the fluid distribution area. Furthermore, in advantageous embodiments, the cross-sectional area of ​​the fluid distribution area (perpendicular to the direction of flow), i.e., more specifically, the portion of the flow path across the fluid distribution area, is constant or substantially constant over the entire length of the fluid distribution area. However, if the height of the flow path is constant or substantially constant, this may be achieved with a constant width over the entire length of the flow path.

[0067] Furthermore, positioning the array of secondary structural columnar embedded elements in an area upstream of the main filter area, i.e., on the higher pressure side of the main filter area where the pressurized medically active fluid impinges on the main filter, can be advantageous as this provides further stabilization of the connection between the base plate and the cover plate of the microstructure nozzle of the present invention. This can be particularly beneficial in mitigating or preventing potential deformation of the base plate and / or cover plate by highly pressurized medically active fluid (up to 300 bar or more), which, in addition to the positioning of the microstructures provided on the base plate, could severely affect their connection to the cover plate and therefore the airtightness of the microstructure nozzle of the present invention or the flow channels provided therein.

[0068] In more specific embodiments, the microstructured nozzle of the present invention may further comprise a first boundary region disposed between (the outlet or downstream end of) the fluid distribution region and (the inlet or upstream end of) the main filter region in the direction of flow, the first boundary region being free of structural elements disposed therein, thereby assisting in the formation of a fluid-gas interface at the outlet side of the distribution region.

[0069] In certain embodiments, such a first boundary region may be a hollow space disposed between fluid distribution regions having a width and height that essentially corresponds to the width and height of the upstream end of the main filter region disposed downstream of the first boundary region, in addition to the width and height of the downstream end of the fluid distribution region disposed upstream of the first boundary region, both of which are described in detail above. However, in alternative embodiments, the first boundary region may also have different dimensions, e.g., a narrower width than one or both of the adjacent regions but the same height as the adjacent regions. In some embodiments, the first boundary region may extend across the entire width of the flow path from one opposing sidewall to the other opposing sidewall, and thus may have a width in the range of up to about 5 mm, e.g., 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. In further embodiments, the length of the first boundary region, i.e., in other words the distance separating the main filter region and the liquid distribution region, may vary within a wide range and may be selected, for example, within the range of about 0.01 mm to about 0.5 mm, or about 0.01 mm to about 0.1 mm or about 0.05 mm.

[0070] In more specific embodiments, the microstructured nozzle of the present invention may further include a second boundary region disposed between the inlet (of the microstructured nozzle of the present invention) and (the inlet or upstream end of) the fluid distribution region, the second boundary region similarly being free of structural elements disposed within the second boundary region, thereby assisting in the formation of a fluid-gas interface on the inlet side of the fluid distribution region.

[0071] In certain embodiments, such a second boundary region may be a hollow space disposed between (the inlet or upstream end of) the fluid distribution region, having a width and height that essentially correspond to the width and height of the inlet (of the microstructured nozzle of the present invention) and the fluid distribution region disposed upstream of the second boundary region, in addition to the width and height of the fluid distribution region disposed downstream of the second boundary region, both of which are described in detail above. However, in alternative embodiments, the second boundary region may also have different dimensions, e.g., a width narrower than the inlet or fluid distribution region, but a height the same as that of the inlet and fluid distribution region. In some embodiments, the second boundary region may extend across the entire width of the flow channel from one opposing sidewall to the other opposing sidewall, and thus may have a width in the range of up to about 5 mm, e.g., 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. In further embodiments, the length of the second boundary region, i.e., in other words the distance separating the inlet of the microstructured nozzle and the liquid distribution region, may vary within a wide range and may be selected, for example, within the range of about 0.01 mm to about 0.5 mm, or about 0.01 mm to about 0.1 mm or about 0.05 mm.

[0072] In still further embodiments, the microstructured nozzle of the present invention may include a coarse filter region disposed between the inlet (of the microstructured nozzle of the present invention) and (the inlet or upstream end of) the fluid distribution region or (if present) the second boundary region, wherein the coarse filter region comprises a coarse filter manufactured as a tertiary structure, wherein a plurality of coarse filter protrusions are arranged in at least one row, each formed as an integral component of and protruding from the base plate, the protrusions being spaced apart from one another by coarse filter channels that form a pathway for fluid through the nozzle from the inlet to the outlet, while the cover plate, when attached to the base plate, covers the coarse filter protrusions and the coarse filter channels.

[0073] According to these embodiments, the optional coarse filter region of the microstructure nozzle of the present invention includes a coarse filter region that includes a coarse filter fabricated as a tertiary structure. If present, the coarse filter is preferably disposed in and formed on the coarse filter region of the base plate, as described in more detail below. In some embodiments, the coarse filter includes a plurality of coarse filter protrusions arranged in at least one row, preferably in a single row, while preferably each coarse filter protrusion may constitute an integral component of the base plate and protrude therefrom. Furthermore, if present, the coarse filter protrusions may be separated from one another by coarse filter channels that form multiple paths for the fluid from the inlet to the outlet (via the second boundary region (if present), the fluid distribution region, the first boundary region (if present), and the main filter region), while the cover plate, when attached to the base plate, covers the coarse filter protrusions and the coarse filter channels.

[0074] The coarse filter region, in some embodiments, extends across the entire width of the flow channel from one opposing sidewall to the other opposing sidewall, and thus may have a width in the range of up to about 5 mm, e.g., 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 to 3 mm, and a length (in the direction of flow) of from about 0.05 mm to about 0.5 mm, or from about 0.1 mm to about 0.3 mm, or about 0.2 mm.

[0075] In certain embodiments, in a microstructured nozzle according to this aspect of the invention, the coarse filter includes a plurality of protrusions extending transversely to the flow direction from the base plate to define a plurality of coarse filter channels. In preferred embodiments, the coarse filter protrusions can have a rectangular or square cross-sectional shape, although other shapes, such as circular, elliptical, or irregular shapes, are also possible. In more specific embodiments, the coarse filter protrusions are arranged side by side across the entire width of the coarse filter area, i.e., from one sidewall of the base plate to the opposing sidewall of the base plate. In some embodiments, the coarse filter protrusions can have a width perpendicular to the direction of flow of about 0.01 mm to about 0.1 mm, or about 0.025 mm to about 0.075 mm, and a length (in the direction of flow) of about 0.05 mm to about 0.3 mm, or about 0.1 mm to about 0.3 mm, or about 0.2 mm. In further embodiments, the coarse filter protrusions can be uniformly distributed across the entire width of the flow channel, preferably at a density of about 3 to about 7 protrusions per centimeter. In further embodiments, the coarse filter channel may provide a width of about 0.05 mm to about 0.3 mm, or about 0.1 mm to about 0.2 mm.

[0076] As described in detail above, the microstructure nozzle of the present invention has at least an inlet, an outlet, and a flow direction between the inlet and the outlet. a fluid distribution region including a secondary structure of columnar built-in elements arranged downstream of the inlet; a primary filter region including a primary filter as a primary structure disposed downstream of the fluid distribution region; and - including a filtrate outlet region located downstream of the main filter region.

[0077] In a further embodiment, the microstructured nozzle of the present invention has at least an inlet, an outlet, and a flow direction between the inlet and the outlet, a fluid distribution region including a secondary structure of columnar built-in elements arranged downstream of the inlet; a first boundary region located downstream of the fluid distribution region; a primary filter region including a primary filter as a primary structure disposed downstream of the first boundary region; and - including a filtrate outlet region located downstream of the main filter region.

[0078] In a further embodiment, the microstructured nozzle of the present invention has at least an inlet, an outlet, and a flow direction between the inlet and the outlet, a second boundary region located downstream of the inlet, a fluid distribution region including a secondary structure of columnar embedded elements disposed downstream of the second boundary region; a first boundary region located downstream of the fluid distribution region; a primary filter region including a primary filter as a primary structure disposed downstream of the first boundary region; and - including a filtrate outlet region located downstream of the main filter region.

[0079] In yet a further embodiment, the microstructured nozzle of the present invention comprises at least an inlet, an outlet, and, disposed in the direction of flow between the inlet and the outlet, a coarse filter region comprising a coarse filter as a tertiary structure, which is arranged downstream of the inlet; a second boundary region located downstream of the coarse filter region; a fluid distribution region including a secondary structure of columnar embedded elements disposed downstream of the second boundary region; a first boundary region located downstream of the fluid distribution region; a primary filter region including a primary filter as a primary structure disposed downstream of the first boundary region; and - including a filtrate outlet region located downstream of the main filter region.

[0080] As already mentioned above, the microstructured nozzle of the present invention may be comprised in an inhalation device, in other words a nebulizer or atomizer for inhalation therapy. Thus, in a second aspect, the present invention provides an inhalation device for inhalation therapy comprising a microstructured nozzle according to the first aspect of the invention. For the avoidance of doubt, it is to be noted that all features, embodiments, explanations or combinations thereof as detailed above in relation to the microstructured nozzle of the first aspect of the invention, wherever applicable, apply equally to the inhalation device of this second aspect of the invention.

[0081] As already mentioned above, inhalation devices intended for generating inhalable aerosols of medically active fluids have been described in the prior art, for example, in the aforementioned U.S. Patent Application Publication No. 2005 / 0001076 and the cited references. Another inhalation device is disclosed in WO 2018 / 197730, the entire contents of which are incorporated herein by reference. These inhalation devices are usually small enough to be held in one hand and operated by a user. They typically comprise a reservoir for holding the medically active fluid to be aerosolized and administered, a pump unit for pressurizing the medically active fluid, specifically a pump unit adapted to generate discrete, defined volumes of highly pressurized medically active fluid, an actuation mechanism, and a nozzle unit through which the medically active fluid pressurized by the pump unit is aerosolized, or in other words, atomized. The predetermined volume of medically active fluid to be aerosolized may be selected within a broad range, in some embodiments, from about 1 μL to about 50 μL, or from about 10 μL to about 25 μL, e.g., about 15 μL. According to a second aspect of the present invention, an inhalation device of the present invention comprises a microstructured nozzle according to the first aspect of the present invention, as described in detail above. Due to the advantages of the microstructured nozzle according to the first aspect of the present invention, as described in detail above, an inhalation device according to this second aspect of the present invention allows for a simplified design of such an inhalation device, in addition to the advantageous features of the microstructured nozzle interacting with further functional units of the inhalation device of the present invention, which may extend its operational life. These advantageous features may include, but are not limited to, advantageous filtration properties, which, in addition to increased mechanical robustness, allow for a simplified design of further units of the inhalation device, e.g., a pump unit, among others.

[0082] In particular, the present invention relates to the following specific embodiments: 1. A microstructured nozzle (1) for a device (100) intended for the generation of 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 direction (X) of fluid flow from the inlet to the outlet, the nozzle comprising: a substantially flat base plate (5) and a cover plate (6) that can be attached thereto; a main filter area (20) including a main filter (21) manufactured as a primary structure, having a plurality of main filter projections (22) arranged side by side in at least one row (23), each main filter projection being formed as an integral component of and projecting from a base plate, the main filter projections being spaced apart by main filter channels (24) forming a path for fluid through the nozzle from the inlet to the outlet, while a cover plate, when attached to the base plate, covers the main filter projections and the main filter channels; a filtrate outlet area (30) arranged in the direction of flow between the main filter and the outlet, and a fluid distribution area (40) arranged in the direction of flow between the inlet and the main filter area (for distribution of unfiltered fluid before contact with the main filter); Equipped with A microstructure nozzle (1) in which a secondary structure (41) is disposed in the fluid distribution region, the secondary structure (41) comprising a plurality of columnar built-in elements (42) extending transversely to the flow direction from the base plate and / or cover plate.

[0083] 2. A microstructured nozzle according to item 1, wherein the inlet is located at the inlet end (7) of the base plate and the outlet is located at the opposite outlet end (8) of the base plate, the inlet and outlet being connected by opposite side walls (9, 10), the inlet and outlet defining a flow path (11) through which the medically active fluid flows in the direction of flow (X), and the outlet comprising at least one ejection channel (12) for ejection of a jet of medically active fluid.

[0084] 3. The microstructure nozzle (1) according to item 2, wherein the protrusion (22) of the main filter (21) is arranged laterally from one of the side walls (9) of the base plate (5) to the opposing side wall (10) of the base plate (5).

[0085] 4. The microstructured nozzle according to any one of items 1 to 3, wherein the outlet comprises at least two ejection channels adapted to eject at least two jets of medically active fluid such that the at least two jets intersect with each other to form an inhalable aerosol.

[0086] 5. The microstructure nozzle according to any one of items 1 to 4, wherein the main filter comprises a plurality of zigzag protrusions extending from the base plate transversely to the flow direction, defining a plurality of channels (24) and forming spikes (25) in the inlet and outlet directions.

[0087] 6. The microstructured nozzle of any one of items 1 to 5, wherein the filtrate outlet region does not include a structural element disposed within the interior volume of the filtrate outlet region.

[0088] 7. The microstructure nozzle of any one of items 1 to 6, wherein one or more spacings between the built-in elements of the secondary structure form flow-through channels for the liquid passing therethrough, and the resulting cross-sectional area transverse to the direction of flow that is effectively permeable to the liquid is greater than the corresponding effective cross-sectional area of ​​the main filter channel formed by the protrusions of the main filter such that the built-in elements do not substantially increase flow resistance.

[0089] 8. The microstructured nozzle according to any one of items 1 to 7, wherein the built-in element of the fluid distribution region has a cylindrical peripheral wall.

[0090] 9. The microstructured nozzle according to any one of items 1 to 8, wherein the built-in elements are spaced from each other by about 0.005 mm to about 0.02 mm.

[0091] 10. The microstructure nozzle according to any one of items 1 to 9, wherein the diameter of the built-in element is from about 0.005 mm to about 0.02 mm.

[0092] 11. The microstructure nozzle according to any one of items 1 to 10, wherein the columnar built-in element extends from the base plate to the cover plate.

[0093] 12. A microstructure nozzle according to any one of items 1 to 11, wherein the protrusions of the main filter are arranged side by side across the entire width of the filter.

[0094] 13. The microstructured nozzle according to any one of items 1 to 12, wherein the built-in element is formed as an integral part of the base plate.

[0095] 14. The microstructured nozzle of any one of items 1 to 13, wherein all of the main filter projections and all of the built-in elements are formed as an integral part of the base plate.

[0096] 15. A microstructure nozzle according to any one of items 1 to 14, wherein the plurality of columnar built-in elements are arranged in a plurality of parallel rows (33) and are arranged transversely to the direction of flow.

[0097] 16. A microstructure nozzle according to any one of items 1 to 15, wherein the plurality of columnar built-in elements are arranged in about 40 to 70 parallel rows per mm (relative to the length of the secondary structure in the direction of flow), preferably about 50 to 60 parallel rows per mm, and extend from one side wall to the opposing side wall.

[0098] 17. A microstructure nozzle according to any one of items 1 to 16, wherein the plurality of columnar built-in elements are arranged in parallel rows of about 10 to about 30, preferably about 15 to about 25, extending from one of the side walls to the opposing side wall perpendicular to the direction of flow.

[0099] 18. A microstructure nozzle according to any one of items 1 to 17, wherein each row of columnar built-in elements of the secondary structure contains about 40 to about 60, preferably about 45 to about 55, built-in elements per mm.

[0100] 19. A microstructure nozzle according to any one of items 1 to 18, wherein each row of columnar built-in elements of the secondary structure contains about 80 to about 120, preferably about 90 to about 110 built-in elements per row.

[0101] 20. A microstructure nozzle according to any one of items 1 to 19, wherein at least some of the built-in elements form a regular hexagonal pattern, the center of each of the hexagonal patterns being formed by a built-in element, and each angle of each of the hexagonal patterns being formed by an adjacent built-in element.

[0102] 21. Built-in element is 1cm 2 21. The microstructure nozzles according to any one of items 1 to 20, wherein the microstructure nozzles are provided in the fluid distribution region in a number of about 200,000 to about 300,000 per nozzle.

[0103] 22. The microstructured nozzle of any one of items 1-21, wherein the fluid distribution area does not overlap with the main filter area.

[0104] 23. The microstructured nozzle of any one of items 1 to 22, wherein the built-in elements of the secondary structure of the fluid distribution region do not contact the primary filter region.

[0105] 24. A microstructure nozzle according to any one of items 1 to 23, wherein the width of the fluid distribution region, specifically the width of the array of columnar boundary elements provided in the fluid distribution region, is constant or substantially constant over the entire length of the fluid distribution region.

[0106] 25. A microstructured nozzle according to any one of items 1 to 24, comprising a first boundary region (50) disposed between the fluid distribution region and the main filter region in the direction of flow, wherein the first boundary region does not include any structural elements disposed within the first boundary region.

[0107] 26. The microstructured nozzle according to any one of items 1 to 25, comprising a second boundary region (60) disposed between the inlet and the fluid distribution region in the direction of flow, wherein the second boundary does not include a structural element disposed within the second boundary region.

[0108] 27. A microstructure nozzle according to any one of items 1 to 26, comprising a coarse filter region (70) arranged between the inlet and the fluid distribution region or the second boundary region, the coarse filter region comprising a coarse filter (71) manufactured as a tertiary structure having a plurality of coarse filter protrusions (72) arranged in at least one row, each formed as an integral component of a base plate and protruding therefrom, the protrusions being spaced apart from one another by coarse filter channels (73) that form a pathway for fluid through the nozzle from the inlet to the outlet, while a cover plate, when attached to the base plate, covers the coarse filter protrusions and the coarse filter channels.

[0109] 28. An inhalation device (100) for inhalation therapy, comprising a microstructured nozzle according to any one of items 1 to 27.

[0110] Detailed Description of the Drawings 1 shows an inhaler device (100) including an inhaler unit (110) and a replaceable reservoir (120) containing a medically active fluid (2) in the form of a cartridge that is inserted into the inhaler device (100). The inhaler unit (110) has a housing (111) with a lower portion (112) that is detachable from the inhaler unit (110) and that is removed to open the housing (111), thereby allowing access to a receiving unit (113) into which the replaceable reservoir in the form of a cartridge (120) can be inserted. The receiving unit (113) further has a connection unit (114) adapted to removably and fluidly connect to a connection port of the replaceable reservoir (120).

[0111] The inhaler unit 110 further comprises a microstructured nozzle 1 disposed at the downstream end of the inhaler unit 110 for nebulization of the medically active fluid 2. The inhaler 100 further comprises a pump unit 130 disposed within the housing 111. As described in detail above, the pump unit 130 is fluidly connected to the reservoir 120 (via the connection unit 114 of the receiving unit 113) and to the nozzle 1, and is adapted to pump the medically active fluid downstream from the reservoir 120 to the nozzle 1.

[0112] The pump unit (130) has an upstream end (131) fluidly connected to the replaceable reservoir (120) and a downstream end (132) fluidly connected to the nozzle (1), and the pump unit (130) further comprises: (i) a riser pipe (133) having an upstream end (134), the riser pipe (133) adapted to function as a piston in the pump unit (130), the riser pipe (133) being firmly fixed to the user-facing (downstream) side of the housing (111) so as to be immovable relative to the housing (111); and (ii) a hollow cylinder (135) arranged upstream of the riser pipe (133), the upstream end (134) of the riser pipe being inserted into the cylinder (135) so as to be longitudinally movable relative to the riser pipe (133).

[0113] As also shown in FIG. 1 , the pump unit (130) comprises (iii) lockable means for storing potential energy (136) when locked and for releasing the stored energy when unlocked, the means (136) being disposed outside of and mechanically coupled to the cylinder (135) such that unlocking the means (136) results in longitudinal propulsive movement of the cylinder (135) towards the downstream end (132) of the pump unit, thereby causing ejection of pressurized medically active fluid (2) through the microstructured nozzle (1).

[0114] Figure 2 shows one embodiment of the base plate (5) of the microfluidic nozzle (1) of the present invention, viewed from the side (see Figures 5A / 5B), which is initially in an open state and may subsequently be covered with a cover plate (6). The microfluidic nozzle (1) has an inlet (3) disposed at the inlet end (7) of the base plate, as well as an outlet (4) disposed on the outlet end (8) of the base plate (5), while the inlets (3, 7) and outlets (4, 8) define a flow direction (X) of the medically active fluid in a downstream direction from the inlets (3, 7) to the outlets (4, 8). The outlet (4) includes two ejection channels (12) through which jets of medically active fluid may be expelled.

[0115] As can be seen in Figure 2, the base plate (5) includes a primary filter region (20) that includes a primary filter (21) fabricated as a primary structure. The primary filter (21) includes a plurality of primary filter projections (22) arranged side by side in at least one row (23) (shown in more detail in Figure 4) that are folded in a zigzag configuration to form spikes (25) and extend from one side wall (9) to the opposing side wall (10), thereby spanning the entire width of the flow passage (11). Each primary filter projection (22) is formed as an integral component of the base plate and projects therefrom (perpendicular to the plane of the projection). As also shown in the enlarged detail of Figure 4, the primary filter projections (22) are spaced apart by primary filter channels (24) that define a path for fluid through the nozzle from the inlets (3, 7) to the outlets (4, 8). The inlets (3, 7) and outlets (4, 8) are connected by opposing side walls (9, 10) of the base plate (5), thereby defining a flow path (11) through which the medically active fluid flows from the inlets (3, 7) in a downstream direction to the outlets (4, 8), and more specifically to the discharge channel (12).

[0116] The base plate (5) further comprises a filtrate outlet region (30) arranged in the direction of flow between the main filter region (20) or main filter (21) and the outlets (4, 8) with the discharge channel (12). As can be seen in the embodiment of Figure 2, the filtrate outlet region (30) is a hollow space or volume without any structural elements therein, connecting the downstream end of the main filter region (20) with the outlets (4, 8) and the discharge channel (12).

[0117] Furthermore, the base plate (5) as shown in the embodiment of Figure 2 includes a fluid distribution area (40) disposed between the inlets (3, 7) and the main filter area (20) in the direction of flow. The fluid distribution area (40) has a secondary structure (41) in the form of an array of uniformly spaced cylindrical built-in elements (42) extending from the base plate (5). Due to the top view of the cylindrical built-in elements (42) of the secondary structure (41), they are shown in Figure 2 as circles corresponding to the top surfaces of multiple cylindrical columns (42) with circular cross sections. As can be best seen in the enlarged detail of Figure 3, the multiple cylindrical built-in elements (42) as shown in this embodiment are arranged in multiple parallel rows (43) and are disposed transversely to the direction of flow (X). Moreover, in the particular embodiment shown, the columns (43) of columnar built-in elements (42) are arranged in an "ABAB" configuration, preferably equidistantly spaced, within columns A and B and between columns A and B, such that the built-in elements (42) that are not located adjacent the upstream or downstream ends of the fluid distribution area (40) or adjacent the opposing sidewalls (9, 10) form a regular hexagonal pattern, with the center of each hexagonal pattern formed by a built-in element (42) and each angle of each hexagonal pattern formed by an adjacent built-in element (42). The columnar built-in elements (42) of the secondary structure (41) are spaced from one another by channels (44) of the secondary structure.

[0118] As can be seen in Figure 2, the fluid distribution region (40) does not overlap with the primary filter region (20), and more specifically, the columnar built-in elements (42) disposed in the fluid distribution region (40) do not contact the primary filter region (20). Furthermore, in the embodiment shown in Figure 2, the fluid distribution region (40) comprises a uniform array of columnar built-in elements (42). Furthermore, the width of the fluid distribution region (40) perpendicular to the direction of flow (X), as well as the width of the array of columnar built-in elements (42) disposed in the fluid distribution region (40), are constant or substantially constant over the entire length of the fluid distribution region (40), extending from one of the opposing sidewalls (9) to the other of the opposing sidewalls (10).

[0119] The base plate (5) as shown in Figure 2 further includes a first boundary region (50) disposed in the direction of flow (X) between the fluid distribution region (40) and the main filter region (20). As can be seen in this embodiment, the first boundary region (50) does not include any structural elements disposed therein, thereby creating a hollow space or volume that separates and connects the downstream end of the fluid distribution region (40) with the upstream end of the main filter region (20) and the main filter (21) disposed therein.

[0120] Additionally, the base plate (5) as shown in Figure 2 further includes a second boundary region (60) disposed in the direction of flow (X) between the inlets (3, 7) and the fluid distribution region (40). As can be seen in this embodiment, the second boundary region (60) does not include any structural elements disposed therein, thereby creating hollow spaces or volumes that separate and connect the inlets (3, 7), or more specifically, the coarse filter region (70), as described below, to the columnar built-in elements (42) disposed at the upstream end of and within the fluid distribution region (40).

[0121] The base plate (5) according to the embodiment shown in FIG. 2 further includes a coarse filter region (70) located in the flow direction (X) between the inlets (3, 7) and the fluid distribution region (40), or more specifically, between the inlets (3, 7) and the second boundary region (60). The coarse filter region (70) includes a coarse filter (71) manufactured as a tertiary structure with a plurality of coarse filter protrusions (72). In the embodiment shown in FIG. 2, the coarse filter protrusions (72) are integrally formed with the base plate (5) as the protrusions (22) of the main filter (21) and the columnar built-in elements (42) of the secondary structure, and are provided in the form of rectangular structures protruding perpendicular to the plane of the protrusions of the base plate (5). In the embodiment shown in FIG. 2, the coarse filter protrusions (72) are arranged in a row of uniformly sized and shaped protrusions, each formed as an integral component of and protruding from the base plate. The coarse filter protrusions (72) are spaced apart from one another by coarse filter channels (73) that form a pathway for medically active fluid through the nozzle from the inlets (3, 7) to the outlets (4, 8), while a cover plate (6, see Figures 5A / 5B) covers the coarse filter protrusions (72) and the coarse filter channels (73) when attached to the base plate (5).

[0122] As is also evident from FIG. 2, the width of the coarse filter channels (73), perpendicular to the direction of flow (X), in some embodiments is an order of magnitude larger than the width of the channels (44) between the columnar built-in elements (42), filtering coarse physical impurities or debris potentially contained in the medically active fluid before contact with the secondary structures of the fluid distribution region (40) or the main filter (21).

[0123] FIG. 3 shows an enlarged top view of the columnar-shaped built-in elements (42) of the secondary structure as provided in a cross section of the fluid distribution region (40), specifically showing enlarged detail of a portion of the secondary structure adjacent the left sidewall (9) and adjacent to the first boundary region (50) located downstream of the fluid distribution region (40) and adjacent to the second boundary region (60) located upstream. In the embodiment shown in FIG. 3, the columnar-shaped built-in elements (42) of the secondary structure are provided in the form of an array including a plurality of equidistant rows (43) of uniformly spaced built-in elements (42) in an ABAB configuration as described in detail above. In this embodiment, the top or bottom row of columnar-shaped built-in elements corresponds to row A, the second bottom row corresponds to row B, followed by another row A. Most notably, this configuration results in only two distinct distances between the sidewall (9) and corresponding sets of rows, thereby creating defined capillary forces acting between the sidewall, the columnar-shaped built-in elements (42), and the medically active fluid.

[0124] Figure 4 shows an enlarged top view of a cross section of a primary filter (21) located in a primary filter region (20) with primary filter protrusions (22) arranged in a row (23) and separated by primary filter channels (24). More specifically, Figure 5 shows spikes (25) of the primary filter (21) in a zigzag shape as shown in Figure 2.

[0125] Figures 5A and 5B show perspective views of a microstructured nozzle (1) according to the present invention, comprising a base plate (5) and a cover plate (6) attached together to form the fully assembled microstructured nozzle (1). More specifically, Figure 5A shows the upstream end (7) of the assembled microstructured nozzle (1) comprising the inlet (3) and coarse filter protrusion (72), as well as the coarse filter channel (73), while Figure 5B shows the opposite downstream end (8) of the assembled microstructured nozzle (1) having two outlet channels (12).

[0126] Finally, Figure 6 shows a perspective view of a cross section of the base plate (5) of the microstructure nozzle (1) shown in the top view of Figure 2. The cross section shown includes the portion of the primary filter (21) located in the primary filter region (20), the secondary structure (41) of the fluid distribution region (40) with cylindrical built-in elements (42) spaced apart by channels (44) of the secondary structure, and the coarse filter protrusions (72) with coarse filter channels (73). The perspective projection allows one to see the height of the primary, secondary, and tertiary structures, i.e., the height of the primary filter protrusions (22) of the cylindrical built-in elements (42), as well as the height of the coarse filter protrusions (73) perpendicular to the base plate (5). [Explanation of symbols]

[0127] 1 Microstructure nozzle 2 Medically active fluids 3. Inlet (of microstructure nozzle) 4 (microstructure nozzle) outlet 5 Base Plate 6 Cover Plate 7 Inlet end (of base plate) 8 (Base putty) outlet end 9,10 Opposite side walls (of the base plate) 11 (microstructure nozzle) flow path 12 Discharge Channel 20 Main filter area 21 Main filter 22 Main filter protrusion 23 Main filter protrusion row 24 Main Filter Channels 25 (Main filter) spikes 30 Filtrate outlet area 40 Fluid distribution area 41 Secondary structure (of fluid distribution region) 42 (Secondary structure) columnar built-in element 43 Built-in element row 44 Secondary Structure Channels 50 First Boundary Region 60 The Second Boundary Region 70 Coarse filter area 71 Coarse Filter 72 Coarse filter protrusion 73 Coarse Filter Channels 100 Inhaler 110 Inhaler unit 111 Cabinet 112 Bottom of the housing 113 Receptor Unit 114 Connection Unit 120 Replaceable Reservoir 130 Pump Unit 131 upstream end of pump unit 132 downstream end of pump unit 133 Riser Pipe 134 Upstream end of riser pipe 135 Hollow Cylinder 136 Lockable means X Flow direction

Claims

1. A microstructured nozzle (1) for a device (100) intended for the generation of an inhalable aerosol of a medically active fluid (2), said microstructured nozzle (1) having a main filter (21), an inlet (3) for an unfiltered fluid (2) and an outlet (4) for a filtered fluid (2), said inlet (3) and said outlet (4) defining a direction (X) of flow of said fluid (2) from said inlet (3) to said outlet (4), said nozzle (1) comprising: a substantially flat base plate (5) and a cover plate (6) that can be attached thereto; a main filter area (20) comprising said main filter (21) manufactured as a primary structure, having a plurality of main filter projections (22) arranged side by side in at least one row (23), each main filter projection (22) being formed as an integral component of said base plate (5) and projecting therefrom, said main filter projections (22) being spaced apart from one another by main filter channels (24) forming a path for said fluid (2) passing through said nozzle (1) from said inlet (2) to said outlet (3), while said cover plate (6), when attached to said base plate (5), covers said main filter projections (22) and said main filter channels (24); a filtrate outlet area (30) located between said main filter (21) and said outlet (4) in the direction of flow (X), and a fluid distribution area (40) arranged in the direction of flow (X) between said inlet (3) and said main filter area (20); Equipped with A microstructure nozzle (1), in which a secondary structure (41) is arranged in the fluid distribution area (40) and which comprises a plurality of columnar built-in elements (42) extending transversely to the flow direction from the base plate (5) and / or the cover plate (6).

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

3. 3. The microstructure nozzle (1) according to claim 1 or 2, wherein all of the columnar built-in elements (42) of the secondary structure provided in the microstructure nozzle (1) of the present invention are arranged in the fluid distribution region (40).

4. The microstructure nozzle (1) according to any one of claims 1 to 3, wherein the columnar built-in elements (42) of the secondary structure are uniformly and regularly distributed over the entire fluid distribution area.

5. The microstructured nozzle (1) according to any one of claims 1 to 4, wherein the filtrate outlet region (30) does not comprise any structural element disposed within an interior volume of the filtrate outlet region (30).

6. 6. The microstructured nozzle (1) according to any one of claims 1 to 5, wherein the filtrate outlet region (30) has the same width as the (downstream end) of the main filter region (20), optionally narrowing gradually or discontinuously in a direction towards the outlet end (4) of the microstructured nozzle (1).

7. 7. The microstructured nozzle (1) of any one of claims 1 to 6, wherein the inlet (3) is arranged at the inlet end (7) of the base plate (5) and the outlet (4) is arranged at an opposite outlet end (8) of the base plate (5), the inlet (3) and the outlet (4) being connected by opposite side walls (9, 10), the inlet (3) and the outlet (4) defining a flow path (11) through which the medically active fluid (2) flows in the flow direction (X), and the outlet (4) comprising at least one ejection channel (12) for ejection of a jet of the medically active fluid (2).

8. 8. The microstructured nozzle (1) according to any one of claims 1 to 7, wherein the outlet (4) comprises at least two discharge channels (12) adapted to expel at least two jets of the medically active fluid (2) so that the jets intersect with each other to form the inhalable aerosol.

9. 9. The microstructure nozzle (1) of claim 1, wherein one or more spacings between the built-in elements (42) of the secondary structure, each forming a through-flow channel (44) for the liquid (2) passing therethrough, have a resulting cross-sectional area transverse to the direction of flow that is effectively permeable to the liquid (2) greater than a corresponding effective cross-sectional area of ​​the main filter channel (24) formed by the protrusions (22) of the main filter (21), such that the built-in elements (42) do not substantially increase flow resistance.

10. The microstructure nozzle (1) according to any one of the preceding claims, wherein the built-in element (42) of the fluid distribution area has a cylindrical peripheral wall.

11. The microstructure nozzle (1) according to any one of the preceding claims, wherein the built-in elements (42) are spaced from each other by between about 0.005 mm and about 0.02 mm.

12. The microstructure nozzle (1) according to any one of the preceding claims, wherein the diameter of the built-in element (42) is between about 0.005 mm and about 0.02 mm.

13. The microstructure nozzle (1) according to any one of the preceding claims, wherein the pillar-shaped built-in element (42) extends from the base plate (5) to the cover plate (6).

14. The microstructure nozzle (1) according to any one of claims 1 to 13, wherein the protrusions (22) of the main filter (21) are arranged side by side across the entire width of the main filter (21).

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

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

17. The microstructure nozzle (1) according to any one of claims 1 to 16, wherein the plurality of columnar built-in elements (42) are arranged in a plurality of parallel rows (43) arranged transversely to the direction of flow.

18. 18. The microstructure nozzle (1) according to any one of the preceding claims, wherein the plurality of columnar built-in elements (42) are arranged in about 40 to about 70 parallel rows (43) per mm (relative to the length of the secondary structure in the direction of flow), preferably about 50 to 60 parallel rows (43) per mm, extending from one of the side walls (9) to the opposing side wall (10).

19. 19. The microstructure nozzle (1) according to any one of claims 1 to 18, wherein the plurality of columnar built-in elements (42) are arranged in about 10 to about 30, preferably about 15 to about 25, parallel rows (43) extending from one side wall (9) to the opposing side wall (10) perpendicular to the flow direction.

20. The microstructure nozzle (1) according to any one of claims 1 to 19, wherein each row (43) of columnar built-in elements (42) of the secondary structure (41) comprises about 40 to about 60, preferably about 45 to about 55, built-in elements (42) per mm.

21. The microstructure nozzle (1) according to any one of claims 1 to 20, wherein each row (43) of columnar built-in elements (42) of the secondary structure (41) comprises about 80 to about 120, preferably about 90 to about 110 built-in elements (42) per row.

22. A microstructure nozzle (1) according to any one of claims 1 to 21, wherein at least some of the built-in elements (42) form a regular hexagonal pattern, the center of each of the hexagonal patterns being formed by a built-in element (42), and each angle of each of the hexagonal patterns being formed by an adjacent built-in element (42).

23. The built-in element (42) is 1 cm ２ The microstructure nozzle (1) of any one of claims 1 to 22, wherein the microstructure nozzle (1) is provided in the fluid distribution area (40) in a number of about 200,000 to about 300,000 per nozzle.

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 microstructure nozzle (1) according to any one of the preceding claims, wherein the built-in element (42) of the secondary structure (41) of the fluid distribution area (40) is not in contact with the main filter area (20).

26. 26. A microstructure nozzle (1) according to any one of claims 1 to 25, wherein the width of the fluid distribution area (40), in particular the width of the array of columnar 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. 27. The microstructure nozzle (1) according to any one of claims 1 to 26, comprising a first boundary region (50) arranged between the fluid distribution region (40) and the main filter region (20) in the direction of flow, the first boundary region (50) not comprising any structural element arranged within the first boundary region (50).

28. 28. The microstructure nozzle (1) of any one of claims 1 to 27, comprising a second boundary area (60) arranged between the inlet (3) and the fluid distribution area (40) in the direction of flow, wherein the second boundary area (60) does not include any structural element arranged within the second boundary area (60).

29. The microstructured nozzle (1) has at least an inlet (3), an outlet (4), and is arranged between the inlet (3) and the outlet (4) in the direction of flow. a fluid distribution area (40) comprising a secondary structure of pillar-shaped built-in elements (42) located downstream of said inlet (3); a first boundary region (50) located downstream of said fluid distribution region (40); a main filter region (20) located downstream of said first boundary region (50) and comprising a main filter (21) as said primary structure; and a filtrate outlet region (30) located downstream of said main filter region (20); A microstructure nozzle (1) according to any one of the preceding claims, comprising:

30. 30. The microstructure nozzle (1) of any one of claims 1 to 29, comprising a coarse filter region (70) arranged between the inlet (3) and the fluid distribution region (40) or the second boundary region (60), the coarse filter region (70) comprising a coarse filter (71) manufactured as a tertiary structure having a plurality of coarse filter protrusions (72) arranged side by side in at least one row, each formed as an integral component of the base plate (5) and protruding therefrom, the protrusions (72) being spaced apart by coarse filter channels (73) forming a path for fluid passing through the nozzle (1) from the inlet (3) to the outlet (4), while the cover plate (6) covers the coarse filter protrusions (72) and the coarse filter channels (73) when attached to the base plate (5).

31. The microstructured nozzle (1) has at least an inlet (3), an outlet (4), and is arranged between the inlet (3) and the outlet (4) in the direction of flow. a coarse filter region (70) comprising a coarse filter (71) as a tertiary structure arranged downstream of said inlet (3), a second boundary region (60) located downstream of said coarse filter region (70), a fluid distribution area (40) comprising a secondary structure of pillar-shaped embedded elements (42) located downstream of said second boundary area (60); a first boundary region (50) located downstream of said fluid distribution region (40); a main filter region (20) comprising a main filter (21) as said primary structure, located downstream of said first boundary region (50), and a filtrate outlet region (30) located downstream of said main filter region (20); A microstructure nozzle (1) according to any one of the preceding claims, comprising:

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

33. 33. The inhalation device (100) of claim 32, wherein the inhalation device (100) is a handheld inhalation device.

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