Aerosol generator component

Abstract

The invention provides an improved exchangeable aerosol generator component (10) for a vibrating mesh nebulizer (20) wherein the aerosol generator component (10) houses the vibrating mesh (120) and electrical contacts (130+, 130-) for electrically connecting the vibrating mesh (120) with the vibration generator, and wherein the casing (100) of the aerosol generator component (10) further houses a flow-control element (140) capable of limiting a flow rate of an air flow to a predefined target flow rate or target flow rate range. The invention provides an improved vibrating mesh nebulizer (20) comprising the aerosol generator component (10).

Description

[0001] TITLE: AEROSOL GENERATOR COMPONENT

[0002] Description

[0003] The invention relates to an aerosol generator component (occasionally abbreviated herein as AGC), in particular, to an aerosol generator component combining both a vibrating mesh as well as flow-control means in a small, simplified and readily exchangeable part, allowing for easy and straightforward customization of the vibrating mesh nebulizer according to the needs of the aerosol therapy.

[0004] BACKGROUND OF THE INVENTION

[0005] Vibrating mesh nebulizers (occasionally abbreviated herein as VMN), i.e., nebulizers which transfer a liquid formulation into an aerosol of liquid droplets for inhalation via means of a vibrating mesh, or vibrating membrane, have been known in the prior art for some time, both stationary table-top devices with a VMN-handset as well as portable, handheld devices (the latter typically battery-operated). In the past, initial attempts have already been made to render these devices as suitable for layperson use as possible, for instance, by reducing the number of components to be assembled and / or by providing features such as asymmetries that allow assembly of components only in a defined orientation, such as described in e.g., EP2724741B1 or W02016003738A1.

[0006] However, these devices still offer several disadvantages, especially with respect to adapting a VMN to different types of aerosol therapies in sustainable ways. For instance, when switching a user, or patient, from a solution formulation to a suspension one, or when switching from a low viscosity formulation to a high(er) viscosity one, oftentimes the mesh, or membrane, needs to be changed, and most of the prior art devices have said mesh soldered, or otherwise permanently affixed, to larger components of the nebulizer, such as the liquid reservoir in EP2724741B1 or W02016003738A1. This means that whenever a new membrane is required, either due to age and / or damage to the old one, or in case of a change in the aerosol therapy, the whole reservoir gets discarded along with the mesh, leading to unnecessary waste. Furthermore, with the membrane soldered, or otherwise permanently affixed, to larger components of the nebulizer, recycling of the mesh (commonly made from metals) and the plastic components of the nebulizer that the mesh comes with is challenging, if not rendered impossible. Moreover, customized aerosol therapy does not only reside in choosing meshes suited to achieve a desired droplet- or particle size range for the aerosol but also involves choosing a desired, predefined target flow rate (typically expressed in liters per minute (L / min), or flow rate range, depending on where in the lungs the aerosol generated by the VMN is to be deposited upon inhalation. For instance, faster flow rates (e.g., >15 L / min for adults) are typically more suited to deliver aerosol to the upper airways, oftentimes aiming for more local drug therapy, whereas slower flow rates (e.g., up to 15 L / min for adults) more commonly target the deeper lungs, oftentimes aiming for a more systemic drug delivery. While the specific flow rate values or ranges, and the regions of the lungs targeted by the choice of the desired, predefined target flow rates, may vary depending on e.g., age, sex, or health status, medical caregivers, such as pulmonologists, are able to select predefined target flow rates for specific intended therapeutic settings. The term 'predefined’ in the context of the present disclosure thus means that the value or range is selected in advance, typically by medical caregivers, and is then controlled by the nebulizer, not by the user.

[0007] Some devices offer a feedback function, such as a visual or acoustic feedback, to the user, or patient, to guide and train them in using the right flow rate for their specific, predefined target flow rate. The more reliable and less user-dependent approach, though, is to provide flow-control means, or more specifically flow rate control means, such as valves which limit how fast a user, or patient, can inhale (i.e., capping the flow rates at a predefined target flow rate range), or in other words, which cause the flow rate during inhalations to level, or plateau, at a predefined target flow rate or flow rate range.

[0008] A different approach to aid more efficient lung deposition - though one that is typically less suited for targeting specific regions of the lung, such as upper airways versus deep lung - is the use of flow-resistance means instead of the flow-control means as described above, for instance, restrictor plates (i.e., perforated disks), such as taught in W02016003738A1, positioned upstream of the vibrating mesh so as to create a laminar air flow in the flow path into which the nebulized formulation is then injected. Laminar air flow is considered to improve lung deposition by reducing impactive losses of the nebulized formulation (typically losses within the device, usually in the mouthpiece, but also in the throat region). However, since the size and shape of the opening(s) in these restrictor plates are fixed, increased inhalation efforts by a user equate to increased flow rates. Since increased inhalation efforts by a user also result in increased flow-resistance, the flow rates may be capped to some degree at an upper limit based on which level of flow- resistance said user feels comfortable with. However, this upper flow rate limit is then user-dependent at best, not predefined, nor controlled by the nebulizer. Hence, nebulizers with restrictor plates typically do not allow for limiting the flow rate to a predefined target value or target range and thus do not allow for a targeted drug delivery to specific regions of the lung. Also, the flow rates and flow resistance fluctuating with a user’s inhalation efforts may negatively impact both the steadiness of breathing and the overall perceived comfort during inhalation therapies, which in turn can lead to poor compliance as well as irregular drug deposition patterns in the lung. Moreover, the need to position these flowresistance means upstream of the vibrating mesh inherently increases the size of the component that would need to be exchanged when aiming to exchange, or replace, the vibrating mesh and the flow-resistance means at the same time.

[0009] Unfortunately, most prior art devices, if not all, offer either no flow rate control at all, or have flow-control means that are built into the main body of the nebulizer, and thus cannot be exchanged or replaced in any convenient manner. This leaves aerosol therapists with less flexibility in finding both the right droplet- or particle size range for the aerosol (usually choice of vibrating mesh) and the right predefined flow rate (mainly choice of flow-control means) for a specific drug product and aerosol therapy.

[0010] It is thus an object of the present invention to provide devices that avoid these drawbacks of the prior art; for instance, by providing components or devices with limited parts, improved recyclability, as well as easier to use and exchange. This object is achieved by the subject matter of the present invention as set forth in the claims.

[0011] SUMMARY OF THE INVENTION

[0012] In a first aspect, the invention provides an aerosol generator component (10) for a vibrating mesh nebulizer (20) comprising a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized, a vibrating mesh (120), a vibration generator capable of causing vibrations of the vibrating mesh (120), thereby nebulizing the liquid formulation (30) housed in the nebulizer’s reservoir (211), and a user interface component (220) with a user interface (221), such as a mouthpiece (222) or facemask (223), from which a user can inhale the nebulized formulation in the form of an aerosol, wherein:

[0013] - the aerosol generator component (10) is provided as an exchangeable component of the vibrating mesh nebulizer (20), - the aerosol generator component (10) comprises a casing (100) which houses the vibrating mesh (120) and electrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with the vibration generator, characterized in that the casing (100) of the aerosol generator component (10) further houses a flow-control element (140) capable of limiting a flow rate of an air flow through said flow-control element (140) to a predefined target flow rate or target flow rate range.

[0014] In a second aspect, the invention provides a vibrating mesh nebulizer (20) comprising a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized, a user interface component (220) with a user interface (221), such as a mouth-piece (222) or a facemask (223), from which a user can inhale the nebulized formulation in the form of an aerosol, a main body (240) comprising electronic components for the operation of the nebulizer (20), including a vibration generator capable of causing vibrations of the vibrating mesh (120), thereby nebulizing the liquid formulation (30) housed in the nebulizer’s reservoir (211), and the aerosol generator component (10) according to the first aspect of the invention, the casing (100) of which houses the nebulizer’s vibrating mesh (120) and electrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with the vibration generator.

[0015] Further objects, aspects, useful embodiments, applications, beneficial effects, and advantages of the invention will become apparent on the basis of the description of the invention, the examples, figures and claims below.

[0016] DESCRIPTION OF THE FIGURES

[0017] The following examples and figures serve to illustrate the invention in exemplary embodiments; however, they should not be understood as restricting the scope of the invention. Any reference signs used in the claims or throughout the description should not be construed as a limitation to the embodiments represented in any of the figures. Further details on the figures follow in the detailed description section below.

[0018] It should further be understood that the figures provided herein represent depictions of the devices and components discussed herein which have been simplified to a degree that allows discussion of said devices and components with respect to their functions, effects and interrelations, yet without necessarily depicting each and every minor detail that may additionally be present in the devices or systems of the present invention. The description may thus contain details not all of which are necessarily visible in the drawings.

[0019] Figure 1A depicts an exploded view of an exemplary embodiment of an aerosol generator component (10) according to the first aspect of the invention, abbreviated herein as AGC, depicted with the rear end (102) of the AGC’s casing (100) on the left-hand side, and the front end (101) on the right-hand side. The casing (100) comprises two releasably connectable units, a front frame unit (103) providing the front end (101), and a rear frame unit (104) providing the rear end (102). Wedged, or clamped between these two casing units, sits a flow-control element (140) in the form of a flow-control plate (141) as well as a vibrating mesh component with a vibrating mesh (120), an annular piezo-element (125), and electrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with a vibration generator (the latter separate from the AGC and not depicted in Fig. 1A). In the depicted embodiment, the flow-control plate (141) comprises a flexible flap (142), here a square-shaped one, surrounded by a slit (143) surrounding three of the four sides of the square-shaped flap, with the fourth side functioning as a hinge securing the flexible flap (142) to the flow-control plate (141) and allowing its bending and / or tilting movement in response to an air flow; typically, the air flow pulled into and through the casing (100) through one or more inlet opening(s) (105) at the rear end (102) during an inhalation. The depicted flow-control plate (141) further comprises a spout (146) for fluidly connecting the AGC, in a leak-tight manner, to a fluid outlet opening (212) of the nebulizer’s reservoir (211); see e.g., Fig. 5B for the latter. The spout (146) is received in, and fits through, a corresponding spout receiving opening (108) in the rear frame unit (104). The flow-control plate (141) further comprises a pressure sensing duct (147), here a borehole running through the flow-control plate (141), for connecting the inner volume of the casing (100) with a pressure sensor (250) provided in the vibrating mesh nebulizer (20) so as to allow for inhalation-triggered aerosol generation upon sensing an inhalation manoeuvre during use of the nebulizer. In the depicted embodiment, the pressure sensing duct (147) is shaped as a protrusion extending from the flow-control plate (141). In Fig. 1A, a similarly shaped blind duct protrusion (here without a borehole) is extending from the flow-control plate (141). The casing’s rear frame unit (104) is provided with corresponding openings (109) for receiving therein the pressure sensing duct (147) and the blind duct so as to ensure a snug fit thereof within the AGC’s casing (100). In the depicted embodiment, the casing’s front frame unit (103) is equipped with a flap-stop element (144) in the form of a bridge (145), or ridge, extending from its inner surface (107f) and being positioned between two outlet openings (106) through which air flow exits the casing (100) at the front end (101) during an inhalation. This flapstop element (144), as implied by its name, stops the bending and / or tilting movement of the flexible flap (142) during inhalation so that the one or more outlet openings (106), here two, are not covered and closed completely but effect a flow restriction to a target range of about 12-30 L / min, or about 12-25 L / min, or about 15-20 L / min. The casing’s front frame unit (103) is further equipped with contact-support pins (160a, 160b), at least one per outer electrical contact (130+, 130 ). These contact-support pins (160a, 160b) provide structural support to the electrical contacts (130+, 130 ), more specifically to the outer connecting sections (132+, 132 ) thereof and their outer contact ends (133+, 133 ), i.e., the parts of the electrical contact (130+, 130 ) that extend from the AGC’s casing (100) and provide for the electric connection to the vibration generator in the vibrating mesh nebulizer (20) when the AGC (10) is inserted therein. The rear frame unit (104) is equipped with corresponding support-pin through-holes (161a, 161b) through which, upon and after assembly of the AGC (10), the contact-support pins (160a, 160b) along with the outer contact ends (133+, 133 ) are inserted in such a way that the outer contact ends (133+, 133 ) get pressed onto, over, or around, the contact-support pins (160a, 160b) and held in place by the inner perimeter of the support-pin through-holes (161a, 161b), with the outer contact ends (133+, 133 ) then being exposed, at the rear end (102) and thus accessible for electrical connection with a vibration generator.

[0020] Preferably, and as shown for the embodiment depicted in Fig. 1A, the AGC is combined with a sealing element (170). The sealing element (170) is made of a flexible material and can be attached to the AGC’s front frame unit (103) in such a way that upon assembly of the AGC in the vibrating mesh nebulizer (20) it sits between a front end (101) of the AGC’s casing (100) and the nebulizer’s user interface component (220) to provide, or improve, a leak- tight fit of the AGC within the nebulizer (20).

[0021] Figure IB shows an exploded view of the aerosol generator depicted in Fig. 1A but rotated approx. 180°, i.e., with the rear end (102) of the AGC’s casing (100) now being on the righthand side, and the front end (101) on the left-hand side. Figures 2 A and 2 B show a frontal view and a side view, respectively, of the exemplary AGC (10) of figures 1 A and IB in assembled state, looking at its front end (101). Figures 2C and 2D show a frontal view and a side view, respectively, of the same AGC (10) in assembled state, looking at its rear end (102).

[0022] Figures 3A and 3B show cross-sectional views of the AGC (10) in assembled state along the B-B axis and the A-A axis indicated in Fig. 2A, respectively.

[0023] Figures 4A-4D depict front- and side views of the flow-control plate (141) of the AGC (10) depicted in Fig. 1A and B, i.e., with the flexible flap (142) being provided as an integral part thereof, here in square shape, and surrounded by a slit (143) surrounding three of the four sides of the square-shaped flap, with the fourth side functioning as a hinge securing the flexible flap (142) to the flow-control plate (141) and allowing its bending and / or tilting movement in response to an air flow. Moreover, the spout (146) for fluidly connecting the AGC (10), in a leak-tight manner, to the fluid outlet opening (212) of the nebulizer’s reservoir (211) is also provided as an integral part of the flow-control plate (141), extending from the plate’s surface facing the AGC’s rear end (102). As can best be seen in Fig. 4B, the spout (146) is shaped such as to provide a snap-fit upon its insertion in, or through, the corresponding spout receiving opening (108) in the rear frame unit (104). This is done, inter alia, to render flow-control plate (141) and the rear frame unit (104) readily connectable during manufacture without the two coming apart too easily. Furthermore, as can best be seen in Fig. 4D, the flow-control plate (141) exhibits a pressure sensing duct (147), here a borehole running through the flow-control plate (141), as well as a blind duct that in the depicted embodiment does not have said borehole.

[0024] Figures 5A-5C depict side views of an exemplary embodiment of a vibrating mesh nebulizer (20) according to the second aspect of the invention, occasionally abbreviated herein as VMN, comprising a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized (liquid not depicted); a user interface component (220) with a user interface (221), such as a mouthpiece(222), from which a user can inhale the nebulized formulation in the form of an aerosol; and - as an exchangeable component of the VMN (20) - the aerosol generator component (10; AGC) according to the first aspect of the invention. As described above, the AGC (10) comprises the vibrating mesh (120) as well as the flow-control element (140) combined in a small, simplified and readily exchangeable part.

[0025] As seen in Fig. 5A, the reservoir component (210) and the user interface component (220) are connected to each other via a first hinge (235); and a reservoir lid (213), provided to prevent spillage of the liquid formulation (30) from the reservoir (211), is connected to the reservoir component (210) via a second hinge (236). These hinges allow for easy cleaning of the respective components (e.g., rinsing everything with water) while at the same time preventing, or reducing the risk of, misplacement and / or misassembly of the components. Moreover, as can also be seen in Fig. 5A, the reservoir component (210) is shaped and sized in such a way that it fits intuitively onto the nebulizer’s main body (240). Once the reservoir component (210) is fitted onto the nebulizer’s main body (240), all the user has to do, is to insert the AGC (10) and close the user interface component (220) as shown in Fig. 5B, locking the latter to the VMN’s main body (240) for instance via a snap- fit mechanism (260’). This secures the AGC (10) in place within the nebulizer (20), connects the outer contact ends (133+, 133 ) of the electrical contacts (130+, 130 ) to their counter-contacts (230+, 230 ) in the main body (240), and provides leak-tight connections (i) between a fluid outlet opening (212) of the reservoir (211) and the AGC’s spout (146) at the rear end (102), and (ii) between the sealing element (170) and the user interface / mouthpiece (221, 222) at the front end (101). All three components (the AGC (10) as well as the VMS’s reservoir component (210) and user interface component (220)) are shaped and sized in such a way that misassembly of the AGC (10) in the nebulizer is prevented; for instance, the user interface component (220) would not close, or fit into its snap- fit (260’) if the AGC (10) were to be oriented incorrectly.

[0026] While not visible as such in Fig. 5A-5C, the main body (240) also houses a battery to operate the nebulizer (20), a pressure sensor (250), and the vibration generator capable of causing vibrations of the vibrating mesh (120), e.g., via an annular piezo element (125), and thereby nebulize the liquid formulation (30).

[0027] Figure 6A depicts an exploded view of an alternative embodiment of the aerosol generator component (10) of Fig. 1. Similar to the AGC depicted in Fig. 1A, the casing (100) shown in Fig. 6A comprises two releasably connectable units, a front frame unit (103) providing the front end (101), and a rear frame unit (104) providing the rear end (102); and wedged, or clamped between these two casing units, sits a flow-control element (140) in the form of a flow-control plate (141) as well as a vibrating mesh component with a vibrating mesh (120), an annular piezo-element (125), and electrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with a vibration generator (not depicted). In the depicted embodiment, the flow-control plate (141) comprises a flexible flap (142), here a flap that is surrounded by a U-shaped slit (143) on three of the four sides of the flap, with the fourth side functioning as a hinge securing the flexible flap (142) to the flowcontrol plate (141) and allowing its bending and / or tilting movement in response to an air flow pulled into and through the casing (100) through one or more inlet opening(s) (105) at the rear end (102) during an inhalation. The depicted flow-control plate (141) further comprises a spout (146) for fluidly connecting the AGC, in a leak-tight manner, to a fluid outlet opening (212) of the nebulizer’s reservoir (211); see e.g., Fig. 5B for the latter. The spout (146) is received in, and fits through, a corresponding spout receiving opening (108) in the rear frame unit (104). The flow-control plate (141) further comprises a pressure sensing duct (147), here a borehole running through the flow-control plate (141), for connecting the inner volume of the casing (100) with a pressure sensor (250) provided in the vibrating mesh nebulizer (20) to allow for inhalation-triggered aerosol generation upon sensing an inhalation manoeuvre during use of the nebulizer. In the depicted embodiment, the pressure sensing duct (147) is shaped as a protrusion extending from the flow-control plate (141). In Fig. 6A, a similarly shaped blind duct protrusion (here without a borehole) is extending from the flow-control plate (141). The casing’s rear frame unit (104) is provided with corresponding openings (109) for receiving therein the pressure sensing duct (147) and the blind duct so as to ensure a snug fit thereof within the AGC’s casing (100).

[0028] The depicted embodiment of Fig. 6A differs from that of Fig. 1A insofar as here the flapstop element (144) is provided in the form of a peg (148), or stud, that is an integral part of, the casing’s rear frame unit (104); hidden from view in Fig. 6A, see Fig. 6B instead. The peg (148), or stud, extends from an inner surface (107r) of the rear frame unit (104) towards the inner volume of the casing (100), and in order for it to be able to stop, or limit, the bending and / or tilting movement of the flexible flap (142) during inhalation, the flowcontrol plate (141) is respectively equipped with a peg hole (149) of appropriate size and shape to fit the peg (148) sealingly therethrough, such that in an assembled state of the AGC (or with at least the rear frame unit (104) and the flow-control plate (141) being wedged together), the peg, or stud, ends up being located behind the flexible flap (142) in the direction of air flow during an inhalation (see e.g., Fig. 10).

[0029] The depicted embodiment of Fig. 6A further differs from that of Fig. 1A in that here the two contact-support pins (160a, 160b), one per outer electrical contact (130+, 130 ), are provided not with the front frame unit (103) itself but instead with a sealing element (170) that is to be attached to the AGC’s front frame unit (103). The rear frame unit (104) is equipped with corresponding support-pin through-holes (161a, 161b) through which, upon and after assembly of the AGC (10), the contact-support pins (160a, 160b) along with the outer contact ends (133+, 133 ) are inserted in such a way that the outer contact ends (133+, 133 ) get pressed onto, over, or around, the contact-support pins (160a, 160b) and held in place by the inner perimeter of the support-pin through-holes (161a, 161b), with the outer contact ends (133+, 133 ) then being exposed, at the rear end (102) and thus accessible for electrical connection with a vibration generator.

[0030] Optionally, the contact-support pins (160a, 160b) can be provided as integral parts of the sealing element (170), as shown in Fig. 6A, meaning that while said pins still need to be formstable, or inherently stable, enough to provide the intended structural support to the electrical contacts (130+, 130 ), they also can be formed from the flexible material of the sealing element (170). Moreover, as also shown in Fig. 6 A, the contact-support pins (160a, 160b) can be provided with a V-shaped leaf spring mechanism which provides both (i) a degree of flexibility when shaping the outer contact ends (133+, 133 ) onto, over, or around them and during insertion through the support-pin through-holes (161a, 161b), and (ii) a subtle contact pressure holding the outer contact ends (133+, 133 ) in place after insertion through the support-pin through-holes and improving electrical contact with a vibration generator once the AGC is assembled in a vibrating mesh nebulizer (20).

[0031] Figure 6B shows an exploded view of the aerosol generator depicted in Fig. 6A but rotated approx. 180°, i.e., with the rear end (102) of the AGC’s casing (100) now being on the righthand side, and the front end (101) on the left-hand side. Here, the above-mentioned peg (148), or stud, of the rear frame unit (104) is visible.

[0032] Figures 7A and 7B show a frontal view and a side view, respectively, of the exemplary AGC (10) of Fig. 6A and 6B in assembled state, looking at its front end (101). Figures 7C and 7D show a frontal view and a side view, respectively, of the same AGC (10) in assembled state, looking at its rear end (102). In the depicted embodiment, both the pressure sensing duct (147) and the blind duct protrusions extending from the flowcontrol plate (141) exhibit a borehole.

[0033] Figures 8A-8E depict side views of a further exemplary embodiment of a vibrating mesh nebulizer (20; VMN) according to the second aspect of the invention, including a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized (liquid not shown); a user interface component (220) with a mouthpiece (222) as the user interface (221); and an aerosol generator component (10; AGC) according to the first aspect of the invention. As described above, the AGC (10) comprises the vibrating mesh (120) as well as the flow-control element (140) combined in a small, simplified and readily exchangeable part. The AGC (10) further comprises one or more ear-shaped handles (111), two in Fig. 8A-D, to facilitate grabbing and holding of the AGC (10) and easier insertion or removal of the AGC (10) into or from the nebulizer (20).

[0034] Unlike depicted in Fig. 5A or 5B, the reservoir component (210) and the user interface component (220) are connected to each other via a first hinge (235) that is positioned at a bottom end of the reservoir component (210) such as to open the gap for inserting the AGC (10) into the nebulizer (20) from the top; i.e., similar to inserting an audio tape into the tape-deck of a recorder. This arrangement may allow for even easier handling during AGC-insertion than the embodiment shown in Fig. 5. Again, a reservoir lid (213) is provided to prevent spillage of the liquid formulation (30) from the reservoir (211) and is connected to the reservoir component (210) via a second hinge (236). These hinges (235, 236) allow for easy cleaning of the respective components (e.g., rinsing everything with water) while at the same time preventing, or reducing the risk of, misplacement and / or misassembly of the components. Moreover, the reservoir component (210) is shaped and sized in such a way that it fits intuitively onto the nebulizer’s main body (240), e.g., the bottom-face of the reservoir component (210) sliding over and onto the top-face of the main body (240). Once the reservoir component (210) is fitted onto the nebulizer’s main body (240), all the user has to do, is to insert the AGC (10) and close the user interface component (220) as shown in Fig. 8A-E, locking the latter to the VMN’s main body (240), for instance via a snap-fit mechanism (260’), and to the reservoir component (210) via a further, or second, snap-fit mechanism (260”). This secures the AGC (10) in place within the nebulizer (20) as depicted in Fig. 9, connects the outer contact ends (133+, 133 ) to their respective counter-contacts (230+, 230 ) in the main body (240), and provides leak-tight connections (i) between a fluid outlet opening (212) of the reservoir (211) and the AGC’s spout (146) at the rear end (102), and (ii) between the sealing element (170) and the user interface / mouthpiece (221, 222) at the front end (101). A third snap-fit mechanism (260”’) is provided with the reservoir component (210) to close, or lock, the hinged reservoir lid (213) in a leak-tight manner.

[0035] All three components - the AGC (10), the reservoir component (210) and the user interface component (220) - are shaped and sized in such a way that misassembly of the AGC (10) in the nebulizer is prevented; for instance, the user interface component (220) would not close, or fit into its snap-fits (260’, 260”) if the AGC (10) were to be oriented incorrectly.

[0036] Figure 9 shows a cross-sectional view of the nebulizer (20) and AGC (10) of Figure 8A-E in assembled state.

[0037] Figure 10 shows an enlarged cross-sectional view of the AGC (10) of Figures 6 to 9 in assembled state. As can be seen here, upon assembly the peg (148), or stud, of the rear frame unit (104) is inserted through the peg hole (149) in the flow-control plate (141) so that it ends up being located behind the flexible flap (142) in the direction of air flow during an inhalation.

[0038] Figures 11A-11D depict side views of a further exemplary embodiment of a vibrating mesh nebulizer (20; VMN) according to the second aspect of the invention. The nebulizer (20) shown in Fig. 11A-D is similar to the embodiment depicted in Fig. 8A-E but differs from the latter insofar as the second and third snap-fit mechanisms (260” and 260’”) are provided not with the reservoir component (210) but as integral parts of the aerosol generator component (10; AGC) instead. For instance, the second snap-fit mechanism (260”) is now provided with the AGC (10) so that said AGC can already be snap-fitted securely into place in the user interface component (220) after sliding the AGC (10) in from the top as depicted in Fig. 11B. This set-up advantageously reduces the risk of the AGC accidentally being dropped or lost during assembly.

[0039] In addition, the ends of the two ear-shaped handles (111’) of the AGC (10), which facilitate grabbing and holding the AGC upon insertion into and removal from the nebulizer (20), are shaped as the male members of the third snap-fit mechanism (260’”) which interlock with the respective female counterparts in the form of two openings in the lid (213) of the reservoir component (210). This means that, when the AGC (10) is inserted in the nebulizer (20) shown in Fig. 11A-D, the third snap-fit mechanism (260’”) both closes, or locks, the hinged reservoir lid (213) in a leak-tight manner and also securely interlocks the AGC (10) and user interface component (220) with the reservoir component (210), as depicted in Fig. 11C and 11D. This advantageously reduces the risk of unintentionally releasing / opening the closed reservoir lid (213) and spilling liquid formulation remaining in the reservoir (211) upon detaching the three conjoined parts (namely, AGC (10), user interface component (220) and reservoir component (210)) from the more moisturesensitive main body (240) of the vibrating mesh nebulizer (20) after use, as depicted in Fig. 12A. For cleaning purposes, the AGC (10), the user interface component (220) and reservoir component (210) can then easily be opened and taken apart as shown in Fig. 12 B and rinsed with water as needed, without risking any water-damage to the sensitive main body (240).

[0040] All depicted embodiments show one of the preferred set-ups of the aerosol generator component (10; AGC) wherein during operational use of the vibrating mesh nebulizer (20; VMN), the vibrating mesh (120) is oriented vertically, or in other words sits upright inside the VMN (20), and wherein further the vibrating mesh (120) is arranged in the same plane, or essentially the same plane, as the flow-control element (140) rather than the two being arranged perpendicular to one another (herein, the flow-control element (140) is depicted in the form of a flow-control plate (141) with a flexible flap (142) and a flap-stop element (144)). This distinguishes the vibrating mesh nebulizer (20) of the present disclosure from prior art devices in which the vibrating mesh (120) is oriented horizontally and in which the mesh and the flow-control means (or, as the case may be, the flow-resistance means) are spaced apart along the nebulizer’s flow path and often perpendicular to one another. One of the benefits achieved by this preferred set-up is that the size, and hence the material requirements, of the AGC (10) can be reduced further.

[0041] DEFINITIONS

[0042] The following expressions as used herein should normally be interpreted as outlined in this section unless the description provides a different meaning in a specific context.

[0043] The terms 'a’, 'an’ or 'the’ do not exclude a plurality, i.e., these singular forms should be understood such as to include plural referents unless the context clearly indicates or requires otherwise. In other words, all references to singular characteristics or limitations of the present disclosure shall include the corresponding plural characteristic or limitation, and vice versa, unless explicitly specified otherwise or clearly implied to the contrary by the context in which the reference is made. The terms 'a’, 'an’ or 'the’ thus have the same meaning as 'at least one’ or as 'one or more’ unless defined otherwise.

[0044] The expressions 'one embodiment’, 'an embodiment’, 'a specific embodiment’ and the like mean that a particular feature, property or characteristic, or a particular group, or combination, of features, properties or characteristics, as referred to in combination with the respective expression, is present in at least one of the embodiments of the invention. The occurrence of these expressions in various places throughout this description do not necessarily refer to the same embodiment. Moreover, the particular features, properties or characteristics may be combined in any suitable manner in one or more embodiments.

[0045] Terms such as 'about’, 'approximately’, 'ca.', 'essentially’, or 'substantially’ are meant to compensate for the variability allowed for in the technical field concerned and inherent in the respective products (e.g., in the pharmaceutical industry and in pharmaceutical products), such as differences in content due to manufacturing variation and / or time- induced product degradation. The terms in connection with an attribute or value include the exact attribute or precise value, as well as any attribute or value typically considered to fall within a normal range or variability accepted in the technical field concerned.

[0046] The term 'comprise’ is to be construed in an open and inclusive sense, as 'including, but not limited to’. The expressions 'substantially consisting of or 'essentially consisting of’ mean that no further components are added other than those listed.

[0047] The term 'unreleasable' is understood to mean that the respectively connected components of the aerosol generator component (10) or of the nebulizer (20) are not releasable, or separable, from one another without requiring brute force and / or without breaking, or risking breaking, the components.

[0048] Terms such as 'drug’, 'active agent’, 'active ingredient’, 'active pharmaceutical ingredient’ (API), or the like are used synonymously herein and refer to a compound or combination of compounds which are pharmaceutically active against an undesired condition. The term 'pharmaceutically acceptable’ means that a material is useful in preparing a pharmaceutical composition that is generally safe, non-toxic and exhibits neither biologically nor otherwise undesirable properties which would prevent, or exclude, it from pharmaceutical use in humans.

[0049] Terms designating a position, orientation, or direction, such as left, right, front, rear, back, top, bottom, up, down and the like, should be understood with reference to the orientation of the disclosed devices or their components under normal operational conditions (i.e., use as intended), and typically from the perspective of the user.

[0050] The term 'flow-control element’ as used herein refers to a technical means that is capable of limiting the flow rate of an air flow to a predefined target rate or target range (e.g., about 12-30 L / min, 12-25 L / min, or 15-20 L / min). In other words, the flow-control element as defined herein refers to a technical means that causes the flow-rate of an air-flow - more specifically the flow rate of a user’s inhalation through the nebulizer - to level, or plateau, at a predefined target value or target range. While initially, right at the start of an inhalation manoeuvre, a user inhaling faster will briefly lead to a respective increase in flow rates, the flow-control element according to this disclosure then ensures that a predefined target flow rate or target flow rate range cannot be surpassed during regular, unlabored inhalation manoeuvres, and that the flow-resistance is kept essentially steady once said predefined value or range is reached. Only upon a user attempting to purposefully and forcefully exceed said target flow rate range would the flow-resistance noticeably increased. Ensuring this upper flow rate limitation without the user having to pay attention to e.g., audible or visual feedback systems, or having to self-regulate their inhalations into a desired target flow rate or flow rate range in other ways, improves user comfort and reproducibility of lung deposition patterns.

[0051] A single unit may fulfil the functions of several features recited in the claims. DETAILED DESCRIPTION OF THE INVENTION

[0052] In a first aspect, the invention provides an aerosol generator component (10) for a vibrating mesh nebulizer (20) comprising a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized, a vibrating mesh (120), a vibration generator capable of causing vibrations of the vibrating mesh (120), thereby nebulizing the liquid formulation (30) housed in the nebulizer’s reservoir (211), and a user interface component (220) with a user interface (221), such as a mouthpiece (222) or facemask (223), from which a user can inhale the nebulized formulation in the form of an aerosol, wherein:

[0053] - the aerosol generator component (10) is provided as an exchangeable component of the vibrating mesh nebulizer (20),

[0054] - the aerosol generator component (10) comprises a casing (100) which houses the vibrating mesh (120) and electrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with the vibration generator, characterized in that the casing (100) of the aerosol generator component (10) further houses a flow-control element (140) capable of limiting a flow rate of an air flow through said flow-control element (140) to a predefined target flow rate or target flow rate range.

[0055] As mentioned above, the term 'predefined’ in the context of the present disclosure means that the value or range that is considered the target is (i) selected in advance, typically by medical staff and with an eye to the desired region of the lungs to be reached by the nebulized formulation; and (ii) is then controlled by the vibrating mesh nebulizer, not by the user inhaling through it; in other words, the term 'predefined’ also means 'user / patient-independent'. Since in the majority of cases, inhaling too slow is not an issue and far more often users, or patients, inhale too fast (resulting in impactive losses in the device and throat as well as the nebulized formulation not reaching the deeper lung), the target value for the flow rate, as used herein, is an upper limit, and the flow-control element (140) according to the present disclosure is the technical means that is capable of limiting the flow rate of an air flow to the predefined target flow rate or target flow rate range, i.e., causing the air flow rate to level, or plateau, at said predefined target. This distinguishes the flow-control element (140) according to the present disclosure from e.g., flow-resistance means, such as perforated disks (occasionally called restrictor plates) which are positioned in the flow path of some nebulizers, upstream of the vibrating mesh, to achieve laminar air flow. These restrictor plates cannot effectively control the flow rate to level, or plateau, at a predefined target value or target range since the shape and size of their opening(s) are fixed; thus, increased inhalation efforts by a user equate to increased flow rates.

[0056] To the best of the inventors’ knowledge, there currently exists no vibrating mesh nebulizer which allows not only the exchange of the vibrating mesh (120) but also the exchange of the flow-control element (140) as described above. Yet, both features are important for providing successful aerosol therapies which are optimized with respect to the formulation to be nebulized as well as the area of the lungs that is targeted. For instance, the option to easily exchange the mesh - and without either wasting larger components of the nebulizer and / or having to revise the vibrating mesh nebulizer as a whole in order to do so - allows aerosol therapists to choose between meshes of different pore geometries (inlet- and outlet diameters, internal structures like 'stepped’ vs. smooth pores) and / or pore counts per area, based on e.g., whether the formulation to be nebulized is a solution, emulsion or suspension, as well as which droplet size they aim to emit from the nebulizer. Similarly, the option to easily exchange the flow-control element (140) allows for a more readily available targeting of upper vs. deeper lung regions using flow-control elements that yield faster and slower flow rates, respectively.

[0057] In one embodiment, the aerosol generator component (10) is provided physically separate from the nebulizer’s reservoir component (210) and / or the user interface component (220), or in other words, the aerosol generator component (10) is fully releasable from at least one of these two components, and preferably fully releasable and physically separate from both, as depicted, for instance, in figures 5A, 5B, 8A, 8B, and 11A. In yet other words, the aerosol generator component (10) is not an integral, or permanently affixed, part of the nebulizer’s reservoir component (210) and / or the user interface component (220). The aerosol generator component (10) thus functions like an exchangeable (spare)part in a vibrating mesh nebulizer (20) that can be assembled in said nebulizer together with the reservoir component (210) and the user interface component (220) as will be explained in more detail below. This offers, inter alia, the benefit that the vibrating mesh (120) and the flow-control element (140) can easily be replaced without discarding, for instance, the larger reservoir and / or user interface components (210, 220) as is currently the case with most of the prior art devices, such as W02016003738A1. It also allows for an easy and straightforward customization of an aerosol therapy when both the flow rates and / or the droplet size of the nebulized liquid can be adjusted readily (via the flow-control element and the mesh, respectively) by simply exchanging the small, compact aerosol generator component (10) while being able to keep all other parts of the vibrating mesh nebulizer the same.

[0058] In one embodiment, the casing (100) of the aerosol generator component (10) comprises a front end (101) facing towards the nebulizer’s user interface (220), e.g., a mouthpiece, and a rear end (102) facing towards the nebulizer’s reservoir (211), when the aerosol generator component (10), the user interface component (220), and the reservoir component (210) are assembled in the vibrating mesh nebulizer (20). The casing (100), also referred to as outer casing, comprises (i) one or more inlet openings (105) at the rear end (102) for air flow to the flow-control element (140) of the aerosol generator component (10) during inhalations of a user, (ii) one or more outlet openings (106) at the front end (101) for air flow from the flow-control element (140) of the aerosol generator component (10), and (hi) a flow passage (110) formed inside and through the casing (100) between these inlet- and outlet-openings (105, 106), directing the air flow from the reservoir (211), past the aerosol generator component (10) and towards the user interface (221).

[0059] The casing (100) is structurally stable, or form-stable, so that the sensitive mesh and electrical contacts encased therein are both supported and prevented from potential damage, especially while handling the aerosol generator component (10) and / or during storage and shipping thereof while not assembled within the nebulizer (20).

[0060] In one embodiment, the casing (100) of the aerosol generator component (10) is formed by at least two outer frame units (103, 104): a front frame unit (103) providing the front end (101) of the casing (100), and a rear frame unit (104) providing the rear end (102) of the casing (100). In a specific embodiment, the two outer frame units (103, 104) are joined by heat stacking, ultra sonic welding, over-moulding, or a snap- fit mechanism, preferably the snap-fit mechanism. Moreover, in this embodiment, the casing’s inlet- and outlet-openings (105, 106) are provided in the rear frame unit (104) and the front frame unit (103), respectively, i.e., during use, when a user inhales at the user interface (220), e.g., a mouthpiece, air enters the aerosol generator component (10) through the inlet opening(s) (105) in the rear frame unit (104) and exits the aerosol generator component (10) through the outlet-opening(s) (106) in the front frame unit (103), flowing towards the user’s airways. In one embodiment, where the casing (100) of the aerosol generator component (10) is formed by at least two outer frame units (103, 104), the vibrating mesh (120) and the electrical contacts (130+, 130 ), are positioned between these two frame units (103, 104).

[0061] In order for the casing (100) to be structurally stable, or form-stable, as indicated above, the front frame unit (103) and the rear frame unit (104) are made of a form-stable material, such as polypropylene (PP), acrylonitrile butadiene styrene (ABS), or the like.

[0062] In one embodiment of the aerosol generator component (10) according to the first aspect, the flow-control element (140) comprises:

[0063] - a flow passage (110) formed inside and through the casing (100) and allowing an air flow from the reservoir (211) towards the user interface (221) during inhalations of a user, the flow passage (110) comprising one or more inlet openings (105) at the casing’s rear end (102), optionally in the rear frame unit (104), and one or more outlet openings (106) at the casing’s front end (101), optionally in the front frame unit (103),

[0064] - a flexible flap (142) inside the flow passage (110) that is movable in response to the inhalative air flow in a bending and / or tilting manner, and

[0065] - a flap-stop element (144) providing an endpoint to this movement of the flexible flap (142).

[0066] In a specific embodiment, the flexible flap (142) and the flap-stop element (144) are adapted such that upon inhalation of a user, the flap (142) is bent and / or tilted in response to the inhalative air flow and pressed against the flap-stop element (144) in such a way that the one or more outlet openings (106) at the front end (101) of the casing (100), optionally in the front frame unit (103), get partially blocked (i.e., not covered and closed completely) so as to limit a flow rate of an air flow through the flow-control element (140) to a predefined target flow rate or target flow rate range. This can be achieved, for instance, either by adjusting the Shore hardness of the flexible flap (142) and / or by adjusting the dimensions of the flap-stop element (144), i.e., how far the flexible flap (142) can move.

[0067] In one embodiment, the flexible flap (142) is provided in a flow-control plate (141) that is positioned between the casing’s front- and rear ends (101, 102), optionally as an integral part of the flow-control plate (141). Typically, the flow-control plate (141) is physically separate from the front- and rear frame units (103, 104) and positioned, or wedged, between the two. This renders the flow-control plate (141) and the flexible flap (142) provided therewith readily adjustable; for instance, during production of the aerosol generator component (10), flow-control plates of varying properties (e.g., flexible flaps of varying designs and / or Shore hardnesses) can be placed, or wedged, between the same front- and rear frame units (103, 104) of the casing (100).

[0068] In a specific embodiment, the flow-control plate (141) is made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar. This is especially true in cases where the flexible flap (142) is an integral part of the flow-control plate (141), so as to allow for the flap’s bending and / or tilting movement. However, providing a flow-control plate (141) made of a flexible material is also beneficial for the provision of the spout (146) on the flow-control plate (141), as will be detailed further below. In a further specific embodiment, as depicted e.g., in Fig. 1A, Fig. 4A-D or Fig. 6A, the flexible flap (142) is formed in the flow-control plate (141) by a slit (143) surrounding at least parts of the outer perimeter of the flexible flap (142), with the respective part of the perimeter not surrounded by the slit (143) functioning as a hinge securing the flexible flap (142) to the flow-control plate (141) and allowing its bending and / or tilting movement in response to an air flow. In a more specific embodiment, the flexible flap (142) is square-shaped, and the slit (143) is provided surrounding three of the four sides of the square-shaped flap, with the fourth side functioning as a hinge securing the flexible flap (142) to the flow-control plate (141) and allowing its bending and / or tilting movement in response to an air flow. This square can either be completely straight on all four sides (i.e., a rectangular flap as in Fig. 1A or 4A-D), or one side could be convexly curved, or rounded, with a U-shaped slit (143) surrounding three of the four sides, as exemplarily depicted in Fig. 6A.

[0069] Based on the Shore hardness of the flexible material chosen for the flexible flap (142) (or for the flow-control plate (141) as a whole if the flexible flap (142) is an integral part thereof) different flow rate ranges can be achieved, for instance, with a lower Shore hardness (i.e., a more flexible, more supple material) providing a flexible flap (142) that is adapting more closely to, or more closely against, the flap-stop element (144), thereby causing a bigger surface fraction of the one or more outlet openings (106) to be covered and thus resulting in a lower flow rate and a higher flow resistance, or flow restriction, in the flow passage (110).

[0070] As mentioned above, both the vibrating mesh (120) and its electrodes (130+, 130 ) as well as the flow-control plate (141) are typically physically separate from the front- and rear frame units (103, 104) and positioned, or wedged, between the two. While this approach of (i) providing a front- and a rear frame unit, and (ii) positioning the mesh, electrodes and flow-control plate therebetween is in no way mandatory, it offers additional benefits in terms of ease of production and assembly of the AGC (10) in the factory, benefits for recycling and sustainability purposes, as well as more flexibility for providing AGC’s (10) that are adaptable to a wider variety of aerosol therapies. For instance, the two outer frame units (103, 104) may be joined by a snap-fit mechanism tight enough that a user cannot easily separate them, but a recycling facility can do so, and then recycle the different parts as needed (e.g., the metal of the mesh and / or the flexible materials of the flow control element separate from the form-stable materials of the frame units). Similarly, different types of meshes and / or flow-control elements can be easily combined between the two frame units (103, 104), like pages in a binder, based on the specific aerosol therapy’s requirements in terms of droplet size and predefined target flow rate.

[0071] In one embodiment, the flap-stop element (144) is made of a form-stable material, such as polypropylene (PP), acrylonitrile butadiene styrene (ABS), or the like. Other materials, namely flexible materials, such as liquid silicone rubber (LSR), thermoplastic elastomer (TPE), or similar, may be suited as well as long as their hardness provides sufficient rigidity to the flap-stop element (144) for it to actually perform its function of stopping the flexible flap’s bending and / or tilting movement at a defined position (equalling a target flow rate range). For this purpose, the flap-stop element (144) is typically positioned in the flow passage (110) between the flexible flap (142) and the one or more outlet openings (106) at the casing’s front end (101) in such a way that the flexible flap (142) is prevented from fully covering the one or more outlet openings (106) even at the flap’s maximum bend and / or tilt.

[0072] In one embodiment, the flap-stop element (144) is provided as a part of, optionally an integral part of, the front frame unit (103). In a specific, embodiment the flap-stop element (144) is provided in the form of a bridge (145), or ridge, extending from an inner surface (107f) of the front frame unit (103), as depicted for instance in Fig. 1A. In a specific embodiment, the flow-control element (140) comprises two outlet openings (106) at the casing’s front end (101), and the flap-stop element (144) is provided in the form of a bridge (145), or ridge, positioned between the two outlet openings (106). As indicated above, the dimensions of the flap-stop element (144), here for instance the height of the bridge (145), can be used - together with the Shore hardness of the flexible flap (142) - to adjust the flow rate to a target flow range: the higher the bridge (145), or, in other words, the further it extends from the inner surface (107f) of the front frame unit (103), the less surface area of the one or more outlet openings (106) is covered, or closed, during an inhalation, thus effecting less flow restriction.

[0073] In an alternative embodiment, the flap-stop element (144) is provided as a part of, optionally an integral part of, the rear frame unit (104). In a specific, embodiment the flapstop element (144) is provided in the form of a peg (148), or stud, extending from an inner surface (107r) of the rear frame unit (104), said peg, or stud (148) being curved or flexed, as depicted e.g., in Fig. 6A. In this embodiment, the flow-control element (140) or, as the case may be, the flow-control plate (141), equipped with the flexible flap (142), is then further equipped with a corresponding peg hole (149), as shown in Fig. 6A and 6B. Said peg hole (149) is adapted in shape and size to sealingly receive therethrough, upon assembly of the AGC, the peg, or stud (148) in such a way that it ends up behind the flexible flap (142) in the direction of air flow during an inhalation (see e.g., Fig. 6B), and thus can stop, or limit, the flap’s bending or tilting motion in response to an inhalative air flow.

[0074] In a further alternative embodiment, the flap-stop element (144) is provided as a part of, optionally an integral part of, a sealing element (170) that is attached to the front frame unit (103), as will be explained in further detail below.

[0075] In one embodiment, the aerosol generator component (10) further comprises a spout (146) for fluidly connecting, in a leak-tight manner, the aerosol generator component (10) to a fluid outlet opening (212) ofthe reservoir (211). This spout (146) can for instance be provided as a part of, optionally as an integral part of the flow-control plate (141), as depicted e.g., in Fig. 4A-D, with the flow-control plate (141) preferably being positioned between the casing’s front- and rear ends (101, 102) and / or made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar. In a specific embodiment, the spout (146) is shaped as a protrusion extending from the flow-control plate (141), and the rear frame unit (104) is provided with a corresponding spout receiving opening (108) for receiving therein the spout (146), thereby allowing to correctly assemble the aerosol generator component (10) and securing the flow-control plate (141) in place within the casing (100). Choosing a flexible material for the flow-control plate (141) - and, where the spout (146) is provided as an integral part thereof, for the spout (146) - is beneficial insofar as flexible materials are better for providing leak-tightness than rigid materials. Moreover, as described above for Fig. 4B, the spout (146) is shaped such as to provide a snap-fit upon its insertion in, or through, the corresponding spout receiving opening (108) in the rear frame unit (104) to facilitate easy assembly during manufacture. Since the casing’s rear frame unit (104) is best prepared from a form-stable material, the insertion of the spout (146) through receiving opening (108) is easier when the spout (146) offers at least some flexibility. Once inserted, the snap-fit between the spout (146) and the rear frame unit (104) helps the latter to firmly press the spout (146) against the fluid outlet opening (212) of the reservoir (211) when the AGC (10) is assembled in the vibrating mesh nebulizer (20). The liquid to be nebulized (30) can then travel from the reservoir (211), through the spout’s central bore to the vibrating mesh (120) without spillage or leakage.

[0076] In one embodiment, the aerosol generator component (10) further comprises a pressure sensing duct (147) for connecting the inner volume of the casing (100) with a pressure sensor (250) provided in the vibrating mesh nebulizer (20), optionally, a pressure sensor (250) provided in the nebulizer’s main body (240), so as to allow for inhalation- triggered aerosol generation upon sensing an inhalation manoeuvre during use of the nebulizer. The pressure sensing duct (147) can, for instance, be provided in the form of a borehole running through the flow-control plate (141), and same as the spout (146), the pressure sensing duct (147) can be provided as a part of, optionally as an integral part of, the flow-control plate (141), with the flow-control plate (141) preferably being positioned between the casing’s front- and rear ends (101, 102) and / or made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar. In a specific embodiment, the pressure sensing duct (147) is shaped as a protrusion extending from the flow-control plate (141), and the rear frame unit (104) is provided with a corresponding opening (109) for receiving the pressure sensing duct (147), thereby allowing to correctly assemble the aerosol generator component (10) and securing the flow-control plate (141) in place within the casing (100). Optionally, similar protrusions, with or without the borehole therethrough, so-called blind ducts (because they do not provide fluid communication with a pressure sensor (250) housed in the nebulizer’s main body (240)), can be provided, with the rear frame unit (104) then being provided with further corresponding openings (109) for receiving not only the pressure sensing duct (147) but the blind duct as well. The embodiment of a flow-control plate (141) with said blind ducts offers the benefit that it stabilizes and secures the flow-control plate (141) in place within the casing (100) more evenly and ensures optimal airtightness of the AGC’s inner compartment and a snug fit of flow-control plate (141) between front- and rear frame units (103, 104). The blind ducts can also be beneficial for symmetry- and manufacturing reasons, for instance, ensuring a less off-set point of gravity of the flow-control plate (141) in automated / machine sorting- and / or assembly processes.

[0077] In one embodiment, the flow-control element (140) of the aerosol generator component (10) according to the first aspect of the invention limits the flow rate to a predefined target of no more than 30 L / min during inhalation. In a specific embodiment, the flow-control element (140) limits the flow rate to a predefined target range of about 12-30 L / min, or about 12-25 L / min, or about 15-20 L / min. In a more specific embodiment, when the flow-control element (140) limits the flow rate to the predefined target or target range, the underpressure is in the range of about 2-10 mbar, or of about 4-8 mbar, preferably 6 mbar ± 1 mbar. As mentioned above, the specific flow rate values or ranges, and the regions of the lungs targeted by the choice of the desired, predefined target flow rates, may vary depending on e.g., age, sex, or health status; yet, medical caregivers, such as pulmonologists, are able to select predefined target flow rates for specific intended therapeutic settings; for instance, faster flow rates for aerosol delivery predominantly to the upper airways (e.g., when aiming for a more local drug therapy), and slower flow rates when targeting the deeper lungs and more systemic drug delivery.

[0078] In one embodiment, the aerosol generator component (10) comprising:

[0079] - a front frame unit (103) and a rear frame unit (104), forming the casing (100) when joined, and providing the casing’s front end (101) and rear end (102), respectively, and

[0080] - a flow-control plate (141) positioned between the front frame unit (103) and the rear frame unit (104), wherein the vibrating mesh (120) and the electrical contacts (130+, 130 ) required to operate the vibrating mesh (120) are positioned between the flow-control plate (141) and the front frame unit (103).

[0081] In a specific embodiment, the vibrating mesh (120) and the electrical contacts (130+, 130 ) are wedged, or clamped, in place between the flow-control plate (141) and the front frame unit (103) upon joining the front- and rear frame units (103, 104), for instance, when joining the front- and rear frame units (103, 104) by heat stacking, ultra sonic welding, over-moulding, or a snap-fit mechanism, preferably the snap-fit mechanism. This offers benefits during manufacturing of the AGC (10) since different meshes (e.g., different mesh materials, different in- or outlet sizes and / or inner geometries of the through-holes in the mesh, etc.) can easily be used in the AGC (10) without needing to adapt the components thereof. It also offers benefits in terms of recyclability insofar as the mesh and the electrical contacts - both of which may contain valuable metals - are not permanently affixed to or joined with any plastic components of the AGC (10) as is often the case with prior art devices. Once the front- and rear frame units (103, 104) of the casing have been separated, the vibrating mesh (120) and the electrical contacts (130+, 130 ) are loose and can easily be retrieved.

[0082] In one embodiment, the electrical contacts (130+, 130 ) comprise outer connecting sections (132+, 132 ) extending to and protruding from the outside of the casing (100) for electric connection of the vibrating mesh (120) with the nebulizer’s vibration generator, wherein each outer connecting section (132+, 132 ) is provided with an outer contact end (133+, 133 ). The latter refers to the area of the outer connecting section (132+, 132 ) that comes into direct physical contact with the corresponding electrical countercontacts (230+, 230 ) ofthe vibrating mesh nebulizer (20), when the AGC (10) is assembled in said nebulizer.

[0083] In one embodiment, the electrical contacts (130+, 130 ) are provided in the form of flexible printed-circuit boards (PCB).

[0084] In one embodiment, the electrical contacts (130+, 130 ) comprise electroconductive copper layers, preferably equipped at least partially with a resistant top-layer, such as a gold-plating, to prevent oxidation and corrosion of the underlying copper-layers. For instance, in one specific embodiment, at least the outer contact ends (133+, 133 ) of the electrical contacts (130+, 130 ) are equipped with a resistant top-layer, such as a gold- plating, for instance, to prevent, or reduce the risk of, corrosion. In a further embodiment, the electrical contacts (130+, 130 ) comprise inner connecting sections (131+, 131 ) located within the casing (100), and the inner connecting sections (131+, 131 ) are equipped with a resistant top-layer, such as a gold-plating. In a specific embodiment, both the outer contact ends (133+, 133 ) and the inner connecting sections (131+, 131 ) are equipped with a resistant top-layer, such as a gold-plating.

[0085] In one embodiment, the aerosol generator component (10) is provided with contactsupport pins (160a, 160b), at least one per outer connecting section (132+, 132 ), so as to provide structural support to the outer connecting sections (132+, 132 ) and their outer contact ends (133+, 133 ) and ensure reliable electric connection to the vibration generator when the aerosol generator component (10) is inserted in the vibrating mesh nebulizer (20). In one embodiment, the contact-support pins (160a, 160b) are made of a form-stable material, such as polypropylene (PP), acrylonitrile butadiene styrene (ABS), or the like. For instance, in one embodiment, these contact-support pins (160a, 160b) are provided with the front frame unit (103) of the AGC’s casing (100), as parts thereof, optionally as integral parts thereof (as depicted e.g., in Fig. 1A), since the front frame unit (103) is typically made of a form-stable material and thus renders the contact-support pins (160a, 160b) form-stable, too.

[0086] Other materials, namely flexible materials, such as liquid silicone rubber (LSR), thermoplastic elastomer (TPE), or similar, may be suited as well as long as their hardness provides sufficient rigidity to the contact-support pins (160a, 160b) for them to actually perform their function of providing structural support to the outer contact ends (133+, 133 )of the outer connecting sections (132+, 132 ). Thus, in an alternative embodiment the contact-support pins (160a, 160b) can, for instance, also be provided as parts of, optionally integral parts of, the flow-control plate (141). In a further alternative embodiment, the contact-support pins (160a, 160b) can be provided as parts of, optionally integral parts of, a sealing element (170) that is attached to the front frame unit (103), as will be explained in further detail below.

[0087] In an optional embodiment, the contact-support pins (160a, 160b) can be provided with a spring mechanism, for instance, a simple, V-shaped leaf spring mechanism as shown e.g., in Fig. 6A and 6B. This spring mechanism provides a degree of flexibility when shaping the outer contact ends (133+, 133 ) of the outer connecting sections (132+, 132 ) onto, over, or around the contact-support pins (160a, 160b), and during insertion of the contactsupport pins (160a, 160b) and the outer contact ends (133+, 133 ) through corresponding support-pin through-holes (161a, 161b; as described further below), thereby reducing the risk of damaging the outer contact ends (133+, 133 ) during these assembly steps. The spring mechanism further provides a subtle contact pressure holding the outer contact ends (133+, 133 ) in place after their insertion through the support-pin through- holes (161a, 161b) and improving their electrical contact with a vibration generator once the AGC is assembled in a vibrating mesh nebulizer (20). Where present, the spring mechanism is not attached to the contact-support pins but formed as an integral part thereof; for instance, during an injection moulding process.

[0088] In one embodiment, the outer contact ends (133+, 133 ) of each outer connecting section (132+, 132 ) are shaped to fit onto, over, or around, the contact-support pins (160a, 160b), and are optionally affixed thereto, preferably without the need for soldering.

[0089] One of the preferred options to affix the outer contact ends (133+, 133 ) to the contactsupport pins (160a, 160b) is where, in one embodiment, the aerosol generator component (10) is further equipped with corresponding support-pin through- holes (161a, 161b) through which, upon and after assembly of the aerosol generator component (10), the contact-support pins (160a, 160b) along with the outer contact ends (133+, 133 ) are inserted in such a way that the outer contact ends (133+, 133 ) get pressed onto, over, or around, the contact-support pins (160a, 160b) and held in place by the inner perimeter of the support-pin through-holes (161a, 161b). In one embodiment, these support-pin through-holes (161a, 161b) are provided with, or through, the rear frame unit (104) of the casing (100) (as depicted e.g., in Fig. 1A), since the rear frame unit (104) is typically made of a formstable material and thus renders the support-pin through-holes (161a, 161b), and specifically the inner perimeter thereof, formstable, too. Yet, in an alternative embodiment and depending on how the flow-control plate (141) is manufactured (e.g., the Shore hardness of the flow-control plate’s flexible material), the support-pin through-holes (161a, 161b) can also be provided with, or through, the flowcontrol plate (141).

[0090] Alternatively, or in addition to the support-pin through-holes (161a, 161b) solution described above, the outer contact ends (133+, 133 ) of the electrical contacts (130+, 130 ) can also be glued to the contact-support pins (160a, 160b).

[0091] As indicated above, in one embodiment, the outer contact ends (133+, 133 ) of the electrical contacts (130+, 130 ) are not soldered to the contact-support pins (160a, 160b). Moreover, in a further embodiment, the contact-support pins (160a, 160b) do not comprise, nor require, additional metal clamps- or springs affixed - e.g., soldered - thereto. This differentiates the device of the present invention from most prior art devices and is beneficial insofar as it allows for bigger ease of manufacturing, lower number of different components, less material use / waste, and lower cost of goods, thus fostering access to high quality therapy to larger patient populations. In contrast, prior art devices often use more componentry utilizing different materials that require a multitude of manufacturing methods and / or manufacturing steps.

[0092] In one embodiment, as depicted e.g., in Fig. 5A, the vibrating mesh (120) is oriented vertically, or substantially vertically, and / or perpendicular to the surface of a liquid formulation (30) filled into the nebulizer’s reservoir (211), when the aerosol generator component (10) is inserted in the vibrating mesh nebulizer (20). This distinguishes the vibrating mesh nebulizer (20) of the present disclosure from prior art devices in which the vibrating mesh is oriented horizontally and / or in parallel with the surface of a liquid formulation filled into the nebulizer’s reservoir. One advantage of the vertical mesh orientation is that it allows for more distinct electromechanical signals once the reservoir is emptied, or only a very small residual volume of the to-be-nebulized liquid formulation remains at the lowest point of mesh and can then switch off the vibration of the mesh in time and to thus prevent excess strain when effective aerosol formation is no longer taking place. In contrast, empirical observation with horizontal meshes showed that a comparatively larger residual volume remains on top of the horizontal mesh which cannot further be nebulized but at the same time causes an electromechanical signal similar to a filled reservoir. This can result in delayed, or omitted, empty-detection and the nebulizer running at higher vibrating amplitudes for longer than intended or necessary and thereby aging or damaging the mesh prematurely due to more extensive mechanical strain.

[0093] According to the present disclosure, the vibrating mesh (120) is oriented vertically, or substantially vertically, and in addition is arranged in the same plane, or essentially the same plane, as the flow-control element (140) when the aerosol generator component (10) is assembled, rather than the mesh and the flow-control element being perpendicular to one another. For instance, figures 3B or 10 show a flow-control element (140) in the form of a flow-control plate (141) provided with a flexible flap (142) that is arranged in the same plane, or essentially the same plane, as the vibrating mesh (120), similar to stacked pages in a binder that is held together by the front- and rear frame units (103, 104) of the casing(100). This distinguishes the vibrating mesh nebulizer (20) of the present disclosure from prior art devices in which the vibrating mesh (120) is oriented horizontally and in which the mesh and the flow-control means - or, as the case may be, the flow-resistance means - are spaced apart along the nebulizer’s flow path (e.g., flow-resistance means positioned upstream of the mesh) and often arranged perpendicular to one another. One of the benefits achieved by this 'stacked pages’ set-up, or 'in same plane’ set-up, is that the size, and hence the material requirements, of the AGC (10) can be reduced.

[0094] In one embodiment, the aerosol generator component (10) is intended for multiple-use.

[0095] As mentioned above, the aerosol generator component (10) according to the first aspect of the invention is a small, simplified and readily exchangeable part intended for use in a vibrating mesh nebulizer and allowing for the easy and straightforward customization thereof based on the needs of the aerosol therapy. In one embodiment, the aerosol generator component (10) exhibits a small size of only about 35-45 mm height (e.g., about 40 mm), about 30-35 mm width (e.g., about 33 mm), and about 8-12 mm thickness (e.g., about 10 mm); dimensions which are achieved inter alia by the above- mentioned 'same plane’ arrangement of the mesh and the flow-control element and which are not possible if, for instance, a flow-resistance means such as a perforated disk, or restrictor plate, needs be placed upstream and with a certain distance from the mesh in order to achieve the desired laminarization of air flow at the position of the mesh, such as in W02016003738A1, or if a flow-restrictor is even housed separate from the aerosol generator component in the nebulizer’s main body instead, such as in EP2724741B1.

[0096] Besides being exchangeable and thus adaptable to various aerosol therapies and formulations to be nebulized, the small size of the aerosol generator component (10) offers the added advantage of requiring fewer materials, for instance less plastic, than prior art devices. Moreover, while prior art nebulizer’s such as those described in EP2724741B1 or W02016003738A1 occasionally offer exchangeable mesh-components, they often have the mesh soldered, or otherwise affixed, to larger components (such as the mesh being permanently affixed to the reservoir component), and thus waste far more plastic when the mesh needs to be changed, either for 'age reasons’ and / or for reasons of requiring a different mesh based on the liquid formulation (30) to be nebulized (e.g., different pore sizes for different viscosities and / or different pore sizes for solutions vs. emulsions or suspensions).

[0097] Optionally, for instance to improve leak-tightness of the nebulizer by ensuring that no air or nascent aerosol can escape the nebulizer (20) other than via its user interface component (220), such as via the mouthpiece (222), a sealing element (170) can be provided at a front end (101) of the AGC’s casing (100); optionally adjoined to the front frame unit (103) thereof.

[0098] In one embodiment, the sealing element (170) is made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar.

[0099] This sealing element (170) can be provided together with the aerosol generator component (10) and is preferably shaped in such a way that it can be attached to the casing (100) at its front end (101), typically to the casing’s front frame unit (103). The sealing element (170) may for instance be made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar, and shaped such as to fit into openings of the front frame unit (103) via a snap-fit, as depicted e.g., in Fig. 1A and Fig. 3 A and 3B.

[0100] Depending on the hardness of the flexible material chosen for the manufacture of the sealing element (170), said sealing element can also take over functions in addition to improving leak-tightness of the nebulizer. For instance, in one embodiment, the sealing element (170) is provided with a flap-stop element (144), optionally in the form of a bridge (145), or ridge, extending from an inner surface (107s) of the sealing element (170); or, in other words, the flap-stop element (144), or bridge (145), are provided as a part of, optionally an integral part of, the sealing element (170) that is attached to the front frame unit (103). It is clear that for this embodiment, the sealing element is then not optional but a required part of the aerosol generator component (10).

[0101] Fig. 1A depicts a similar embodiment where the flap-stop element (144) is provided in the form of a bridge (145), or ridge, extending from an inner surface (107f) of the front frame unit (103) and positioned between two outlet openings (106); the latter being provided in both the front frame unit (103) and the sealing element (170). As can be seen in Fig. 1A, the two outlet openings of the sealing element fit through the two outlet openings of the front frame unit (103). In the above-mentioned alternative embodiment, the flap-stop element (144) would still be provided as a bridge (145), or ridge, flanked on either side by two outlet openings (106), but the bridge (145) and the two outlet openings (106) would be joined as part of the sealing element (170) and snap-fitted as a whole through a wider receiving opening in the front frame unit (103). In a further embodiment, the sealing element (170) is provided with the contact-support pins (160a, 160b); or, in other words, the contact-support pins (160a, 160b) are provided as integral parts of the sealing element (170), as shown in Fig. 6A. This can be done, for instance, if the flexible material of the sealing element (170) is still sufficiently formstable to provide the intended structural support to the electrical contacts (130+, 130 ). In a specific embodiment, also shown in Fig. 6A, the contact-support pins (160a, 160b) can then additionally be provided with a V-shaped leaf spring mechanism as described above.

[0102] Optionally, the aerosol generator component (10) according to the first aspect of the invention may also be equipped with an RFID-tag (Radio Frequency Identification) which may, for instance, contain identifying information such as a specific drug, or a list of drugs and / or drug formulations, that the AGC (10) is particularly suited for in terms of the mesh (droplet size) it houses, and / or the flow restriction it provides. The vibrating mesh nebulizer (20) may in turn comprise the respective RFID -reader capable of receiving and reading the information stored in the RFID-tag; for instance, so as to control the dose(s) administered and other parameters related to the operation of the vibrating mesh nebulizer (20).

[0103] In one embodiment, the aerosol generator component (10) according to the first aspect of the invention, as described above, may further be equipped with one or more ear-shaped handles (111, 111’), for instance two as depicted in Fig. 8A-D or in Fig. 11A-D, to facilitate grabbing and holding of the AGC (10) and easier insertion or removal of the AGC (10) into or from the nebulizer (20). In a specific embodiment, as depicted e.g., in Fig. 11A-D, the one or more ear-shaped handles (111’) of the AGC (10) serve not only as a means to comfortably hold and position the AGC (10) but additionally act as a member of a snap-fit mechanism interlocking with a respective counterpart provided on the reservoir component (210) and / or on the user interface component (220). For instance, in the embodiment shown in Fig. 11A-D, the one or more ear-shaped handles (111’) of the AGC (10) act as the male member of the third snap-fit mechanism (260’”) which interlocks with the respective female counterpart provided as two openings in the lid (213) of the reservoir component (210). When the AGC (10) is inserted in the nebulizer (20) shown in Fig. 11A-D, the third snap-fit mechanism (260’”) both closes, or locks, the hinged reservoir lid (213) in a leak-tight manner and also securely interlocks the AGC (10) and user interface component (220) with the reservoir component (210), as depicted in Fig. 11C and 11D. This advantageously reduces the risk of unintentionally releasing / opening the closed reservoir lid (213) and spilling liquid formulation remaining in the reservoir (211) upon detaching the three conjoined parts (AGC (10), user interface component (220) and reservoir component (210)) from the more moisture-sensitive main body (240) of the vibrating mesh nebulizer (20) after use, as depicted in Fig. 12 A. For cleaning purposes, the AGC (10), the user interface component (220) and reservoir component (210) can then easily be opened and taken apart as shown in Fig. 12B and rinsed with water as needed.

[0104] In a second aspect, the present invention provides a vibrating mesh nebulizer (20) comprising:

[0105] - a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized,

[0106] - a user interface component (220) with a user interface (221), such as a mouthpiece (222) or a facemask (223), from which a user can inhale the nebulized formulation in the form of an aerosol,

[0107] - a main body (240) comprising electronic components for the operation of the nebulizer (20), including a vibration generator capable of causing vibrations of the vibrating mesh (120), thereby nebulizing the liquid formulation (30) housed in the nebulizer’s reservoir (211), and

[0108] - the aerosol generator component (10) according to the first aspect of the invention, the casing (100) of which houses the nebulizer’s vibrating mesh (120) and electrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with the vibration generator.

[0109] Since the vibrating mesh nebulizer (20) according to the second aspect of the invention (occasionally abbreviated herein as VMN, or referred to shortly as nebulizer) comprises the aerosol generator component (10) according to the first aspect of the invention (occasionally abbreviated herein as AGC), any embodiments, or specific or preferred embodiments, disclosed herein in connection with the aerosol generator component (10) according to the first aspect of the invention, may be applied to the vibrating mesh nebulizer (20) according to this second aspect of the invention.

[0110] Besides being equipped with the AGC (10) (i.e., a small, simplified and readily exchangeable part of the vibrating mesh nebulizer, allowing for easy and straightforward customization based on the needs of the aerosol therapy), the vibrating mesh nebulizer (20) as such has also been adapted for maximum user comfort and lowest risk of misassembly or other handling mistakes. For instance, in one embodiment, the nebulizer (20) comprises a mouthpiece (222), and the mouthpiece (222) is an integral part of the user interface component (220), thus reducing the number of components to be assembled by a user. In a further embodiment, the reservoir component (210) and the user interface component (220) are provided in joint form, with the two components being connected via a first hinge (235), thus (further) reducing the number of components to be assembled by a user.

[0111] This first hinge (235) can be positioned either (i) as depicted in Fig. 5A or 5B (i.e., with the first hinge being located at a top- or upper end of the reservoir component (210) when the device is held, or looked at, in its operating orientation); or (ii) as depicted in Fig. 8A-E and Fig. 11A-D (i.e., with the first hinge being located at a bottom- or lower end of the reservoir component (210) when the device is held, or looked at, in its operating orientation) such as to open the gap for inserting the AGC (10) into the nebulizer (20) from the top; similar to inserting an audio tape into the tape-deck of a recorder. Depending on preferences and / or dexterity of the user(s), the 'tape-deck’ arrangement depicted in Fig. 8A-E and Fig. 11A-D may allow for even easier handling during AGC-insertion than the arrangement shown in Fig. 5.

[0112] In one embodiment, the reservoir component (210) comprises a reservoir lid (213) to prevent spillage of the liquid formulation (30) from the reservoir (211). In a specific embodiment, the reservoir component (210) and the reservoir lid (213) are provided in joint form, with the two components being connected via a second hinge (236), thus (further) reducing the number of components to be assembled by a user.

[0113] In an alternative embodiment, the reservoir component (210), the reservoir lid (213), and the user interface component (220) are provided in joint form, with all three components being connected via a first hinge (235), thus (further) reducing the number of components to be assembled by a user.

[0114] In an optional embodiment, the reservoir lid (213) is adapted to open automatically upon detachingthe joint reservoir / user interface assembly (210, 220) from the nebulizer’s main body (240), thus allowing for easy access to, and cleaning of, the reservoir (211), and reminding the user that the reservoir component (210), and in particular the reservoir (211), should be cleaned after use, for instance by rinsing it under a tap. Since the reservoir component (210) and the user interface component (220) are preferably provided in joint form, as described above, rinsing the reservoir component (210) automatically leads the user to also clean the user interface component (220), e.g., the mouthpiece (222). In a more preferred embodiment, though, the reservoir lid (213) is adapted to remain locked upon detaching the conjoined AGC / reservoir / user interface assembly (10, 210, 220) from the main body (240) of the vibrating mesh nebulizer (20) after use (as depicted in Fig. 12A) so as to prevent unintentionally spilling any liquid formulation still remaining in the reservoir (211) onto the more moisture-sensitive main body (240) which houses most of the electronics. In the embodiment shown in Fig. 11A-D, this locking of the reservoir lid (213) is achieved, for instance, by shaping the one or more ear-shaped handles (111’) of the AGC (10) in such a way that they can act as the male member of the third snap-fit mechanism (260”’) which interlocks with the respective female counterpart provided as two openings in the lid (213); see Fig. 11C and 11D. For cleaning purposes, the AGC (10), the user interface component (220) and reservoir component (210) can then easily be opened and taken apart as shown in Fig. 12B and rinsed with water as needed, without risking any water-damage to the sensitive main body (240).

[0115] In one of the preferred embodiments, the nebulizer is delivered to the user, e.g., upon purchase, in a pre-assembled form, i.e., with the aerosol generator component (10), the reservoir component (210), the user interface component (220), and the main body (240) already assembled as required for immediate use. This could for instance be the case in a starter kit for a user with all components needed for initiation of the aerosol therapy included and the right assembly being shown. Typically, this starter kit also comprises printed or computer-readable instructions for assembly and use of the device.

[0116] Alternatively, a starter kit could, of course, contain the aerosol generator component (10), the reservoir component (210), the user interface component (220), and the main body (240) individually packed, or packed separate from one another, such as in a shrinkwrap package with the components being spaced apart within the same primary packaging. In this case, the 'starter kit’ should comprise printed or computer-readable instructions for assembly and use of the device to allow for correct use. Optionally, the packaging could house the components in a manner resembling the exploded view as depicted e.g., in Fig. 5A to allow for an intuitive understanding how they belong together.

[0117] In addition to starter-kits comprising all components, each component can also be obtained individually by the user, in particular the aerosol generator component (10), to account for replacements advisable either due to age and / or damage to the component(s) or, more importantly, to allow for adaptations to the aerosol therapy; for instance, when the lung performance of a user, or patient, improves and he / she can tolerate an increased flow resistance; or when a change of the formulation to be nebulized necessitates a different mesh (120), or the like.

[0118] According to the invention, the vibrating mesh (120) is not permanently affixed to, or provided as an integral part of, the reservoir component (210), as is often the case with prior art devices. Instead, the vibrating mesh (120) is housed within the far smaller AGC (10), as described above, and can thus be replaced less wasteful than in the past.

[0119] In one embodiment, the vibrating mesh (120) is brought in fluid connection with a fluid outlet opening (212) of the reservoir (211) only when the aerosol generator component (10) is inserted in the vibrating mesh nebulizer (20). In one embodiment, the fluid connection between the vibrating mesh (120) and the fluid outlet opening (212) of the reservoir (211) is provided in a leak-tight manner via a spout (146) comprised in the aerosol generator component (10). In a specific embodiment, this spout (146) is provided as a part of, optionally as an integral part of, a flow-control plate (141) which is positioned between front- and rear ends (101, 102) of the AGC’s casing (100), and which is made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar. In a more specific embodiment, the spout (146) is shaped as a protrusion extending from the flow-control plate (141), and the fluid outlet opening (212) of the reservoir (211) is shaped such as to receive the spout (146) therein.

[0120] In one embodiment, the aerosol generator component (10) is positioned, optionally wedged / clamped, between the reservoir component (210) and the user interface component (220), as can be seen e.g., in Fig. 5, Fig. 8, Fig. 9, or Fig. 11.

[0121] In one embodiment, a sealing element (170) is provided between a front end (101) of the casing (100) of the aerosol generator component (10), optionally the front frame unit (103), and the user interface component (220). This sealing element can be beneficial to improve leak-tightness of the nebulizer and ensure, for instance, that no air or nascent aerosol can escape the nebulizer other than via the user interface component (220), such as via the mouthpiece (222). In one embodiment, the sealing element (170) is made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar. In one embodiment, the vibrating mesh nebulizer (20) is equipped with a pressure sensor (250), optionally a pressure sensor housed within the nebulizer’s main body (240), to allow for inhalation-triggered aerosol generation upon sensing an inhalation manoeuvre during use of the nebulizer. Access to this pressure sensor is provided via the AGC’s pressure sensing duct (147).

[0122] In one embodiment, the vibrating mesh nebulizer (20) is a portable, handheld device, i.e., a device whose size and weight render it suitable to be carried comfortably and for extended periods of time (such as the whole day and / or on a daily basis) by human users of said product without additional help; for instance, by simply holding it in one hand or by placing it in the pockets of trousers or coats or in a handbag.

[0123] In one embodiment, the vibrating mesh nebulizer (20) is battery-operated. In a specific embodiment, said battery is located in the nebulizer’s main body (240).

[0124] Optionally, the vibrating mesh nebulizer (20) comprises an RFID-reader capable of receiving and reading information stored in an RFID -tag comprised in the aerosol generator component (10); for instance, so as to control the dose(s) administered and other parameters related to the operation of the vibrating mesh nebulizer (20).

[0125] The following list of numbered items are embodiments comprised by the present invention:

[0126] Item list

[0127] 1. An aerosol generator component (10) for a vibrating mesh nebulizer (20) comprising a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized, a vibrating mesh (120), a vibration generator capable of causing vibrations of the vibrating mesh (120), thereby nebulizing the liquid formulation (30) housed in the nebulizer’s reservoir (211), and a user interface component (220) with a user interface (221), such as a mouthpiece (222) or facemask (223), from which a user can inhale the nebulized formulation in the form of an aerosol, wherein:

[0128] - the aerosol generator component (10) is provided as an exchangeable component of the vibrating mesh nebulizer (20),

[0129] - the aerosol generator component (10) comprises a casing (100) which houses the vibrating mesh (120) and electrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with the vibration generator, characterized in that the casing (100) of the aerosol generator component (10) further houses a flow-control element (140) capable of limiting a flow rate of an air flow through said flow-control element (140) to a predefined target flow rate or target flow rate range.

[0130] 2. The aerosol generator component (10) according to item 1, wherein said component is provided physically separate from the nebulizer’s reservoir component (210) and / or the user interface component (220).

[0131] 3. The aerosol generator component (10) according to items 1 or 2, wherein the casing (100) comprises a front end (101) facing towards the user interface (220), and a rear end (102) facing towards the reservoir (211), when the aerosol generator component (10), the user interface component (220), and the reservoir component (210) are assembled in the vibrating mesh nebulizer (20).

[0132] 4. The aerosol generator component (10) according to item 3, wherein the casing (100) comprises one or more inlet openings (105) at the rear end (102) for air flow to the flow-control element (140) of the aerosol generator component (10) during inhalations of a user, one or more outlet openings (106) at the front end (101) for air flow from the flowcontrol element (140) of the aerosol generator component (10), and a flow passage (110) formed inside and through the casing (100) between these inlet- and outlet-openings (105, 106), directing the air flow from the reservoir (211) towards the user interface (221).

[0133] 5. The aerosol generator component (10) according to items 3 or 4, wherein the casing (100) is formed by at least two outer frame units (103, 104): a front frame unit (103) providing the front end (101) of the casing (100), and a rear frame unit (104) providing the rear end (102) of the casing (100), wherein optionally the two outer frame units (103, 104) can be joined, for instance, by heat stacking, ultra sonic welding, over-moulding, or a snap-fit mechanism, preferably the snap-fit mechanism

[0134] 6. The aerosol generator component (10) according to item 5, wherein the inlet- and outlet-openings (105, 106) are provided in the rear frame unit (104) and the front frame unit (103), respectively. The aerosol generator component (10) according to items 5 or 6, wherein the vibrating mesh (120), and the electrical contacts (130+, 130 ), are positioned between the two frame units (103, 104). The aerosol generator component (10) according to any one of items 5 to 7, wherein the front frame unit (103) and the rear frame unit (104) are joined by heat stacking, ultra sonic welding, over-moulding, or a snap-fit mechanism, preferably by the snap- fit mechanism. The aerosol generator component (10) according to any one of items 5 to 8, wherein the front frame unit (103) and the rear frame unit (104) are made of a form-stable material, such as polypropylene (PP), acrylonitrile butadiene styrene (ABS), or the like. The aerosol generator component (10) according to any one of items 4 to 9, wherein the flow-control element (140) comprises:

[0135] - a flow passage (110) formed inside and through the casing (100) and allowing an air flow from the reservoir (211) towards the user interface (221) during inhalations of a user, the flow passage (110) comprising one or more inlet openings (105) at the casing’s rear end (102), optionally in the rear frame unit (104), and one or more outlet openings (106) at the casing’s front end (101), optionally in the front frame unit (103),

[0136] - a flexible flap (142) inside the flow passage (110) that is movable in response to the inhalative air flow in a bending and / or tilting manner, and

[0137] - a flap-stop element (144) providing an endpoint to this movement of the flexible flap (142). The aerosol generator component (10) according to item 10, wherein the flexible flap (142) and the flap-stop element (144) are adapted such that upon inhalation of a user, the flap (142) is bent and / or tilted in response to the inhalative air flow and pressed against the flap-stop element (144) in such a way that the one or more outlet openings (106) at the front end (101) of the casing (100), optionally in the front frame unit (103), get partially blocked so as to limit a flow rate of an air flow through the flow-control element (140) to a predefined target value or target range. The aerosol generator component (10) according to items 10 or 11, wherein the flexible flap (142) is provided in a flow-control plate (141) that is positioned between the casing’s front- and rear ends (101, 102), optionally as an integral part of the flow-control plate (141). The aerosol generator component (10) according to item 12, wherein the flowcontrol plate (141) is made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar. The aerosol generator component (10) according to items 12 or 13, wherein the flexible flap (142) is formed in the flow-control plate (141) by a slit (143) surrounding at least parts of the outer perimeter of the flexible flap (142), with the respective part of the perimeter not surrounded by the slit (143) functioning as a hinge securing the flexible flap (142) to the flow-control plate (141) and allowing its bending and / or tilting movement in response to an air flow. The aerosol generator component (10) according to item 14, wherein the flexible flap (142) is square-shaped, and the slit (143) is provided surrounding three of the four sides of the square-shaped flap, with the fourth side functioning as a hinge securing the flexible flap (142) to the flow-control plate (141) and allowing its bending and / or tilting movement in response to an air flow. The aerosol generator component (10) according to items 12 to 15, wherein the flow-control plate (141) is physically separate from the front- and rear frame units (103, 104) and positioned between the two. The aerosol generator component (10) according to items 10 to 16, wherein the flapstop element (144) is made of a form-stable material, such as polypropylene (PP), acrylonitrile butadiene styrene (ABS), or the like, or alternatively other materials, such as liquid silicone rubber (LSR), thermoplastic elastomer (TPE), or similar, as long as they provide sufficient rigidity, and wherein optionally the flap-stop element (144) is positioned in the flow passage (110) between the flexible flap (142) and the one or more outlet openings (106) at the casing’s front end (101) in such a way that the flexible flap (142) is prevented from fully covering the one or more outlet openings (106) even at the flap’s maximum bend and / or tilt. The aerosol generator component (10) according to item 17, wherein the flap-stop element (144) is provided in the form of a bridge (145), or ridge, extending from an inner surface of the front frame unit (103). The aerosol generator component (10) according to item 18, wherein the flowcontrol element (140) comprises two outlet openings (106) at the casing’s front end (101), and wherein the flap-stop element (144) is provided in the form of a bridge (145), or ridge, positioned between the two outlet openings (106). The aerosol generator component (10) according to any one of items 1 to 19, further comprising a spout (146) for fluidly connecting, in a leak-tight manner, the aerosol generator component (10) to a fluid outlet opening (212) of the reservoir (211). The aerosol generator component (10) according to item 20, wherein the spout (146) is provided as a part of, optionally as an integral part of the flow-control plate (141), with the flow-control plate (141) preferably being positioned between the casing’s front- and rear ends (101, 102) and / or made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar. The aerosol generator component (10) according to item 21, wherein the spout (146) is shaped as a protrusion extending from the flow-control plate (141), and wherein the rear frame unit (104) is provided with a corresponding opening (108) for receiving therein the spout (146), thereby allowing to correctly assemble the aerosol generator component (10) and securing the flow-control plate (141) in place within the casing (100). The aerosol generator component (10) according to any one of items 1 to 22, further comprising one or more pressure sensing duct(s) (147) for connecting the inner volume of the casing (100) with a pressure sensor (250) provided in the vibrating mesh nebulizer (20) so as to allow for inhalation-triggered aerosol generation upon sensing an inhalation manoeuvre during use of the nebulizer. The aerosol generator component (10) according to item 23, wherein the one or more pressure sensing duct(s) (147) are provided as part(s) of, optionally as integral part(s) of, the flow-control plate (141), with the flow-control plate (141) preferably being positioned between the casing’s front- and rear ends (101, 102) and / or made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar.

[0138] 25. The aerosol generator component (10) according to item 24, wherein the one or more pressure sensing duct(s) (147) are shaped as protrusions extending from the flow-control plate (141), and wherein the rear frame unit (104) is provided with corresponding openings (109) for receiving therein the one or more pressure sensing duct(s) (147), thereby allowing to correctly assemble the aerosol generator component (10) and securing the flow-control plate (141) in place within the casing (100).

[0139] 26. The aerosol generator component (10) according to any one of items I to 25, wherein the flow-control element (140) limits the flow rate to a predefined target of no more than 30 L / min during inhalation.

[0140] 27. The aerosol generator component (10) according to any one of items 1 to 26, wherein the flow-control element (140) limits the flow rate to a predefined target range of about 12-30 L / min, or about 12-25 L / min, or about 15-20 L / min.

[0141] 28. The aerosol generator component (10) according to items 26 or 27, wherein, when the flow-control element (140) limits the flow rate to the predefined target or target range, the underpressure is in the range of about 2-10 mbar, or of about 4-8 mbar, preferably 6 mbar ± 1 mbar.

[0142] 29. The aerosol generator component (10) according to any one of items 1 to 28, the aerosol generator component (10) comprising:

[0143] - a front frame unit (103) and a rear frame unit (104), forming the casing (100) when joined, and providing the casing’s front end (101) and rear end (102), respectively, and

[0144] - a flow-control plate (141) positioned between the front frame unit (103) and the rear frame unit (104), wherein the vibrating mesh (120) and the electrical contacts (130+, 130 ) required to operate the vibrating mesh (120) are positioned between the flow-control plate (141) and the front frame unit (103).

[0145] 30. The aerosol generator component (10) according to item 29, wherein the vibrating mesh (120) and the electrical contacts (130+, 130 ) are wedged, or clamped, in place between the flow-control plate (141) and the front frame unit (103) upon joining the front- and rear frame units (103, 104), for instance, when joining the front- and rear frame units (103, 104) by heat stacking, ultra sonic welding, over-moulding, or a snap-fit mechanism, preferably the snap-fit mechanism.

[0146] 31. The aerosol generator component (10) according to items 1 to 30, wherein the electrical contacts (130+, 130 ) comprise outer connecting sections (132+, 132 ) extending to and protruding from the outside of the casing (100) for electric connection of the vibrating mesh (120) with the nebulizer’s vibration generator, wherein each outer connecting section (132+, 132 ) is provided with an outer contact end (133+, 133 ).

[0147] 32. The aerosol generator component (10) according to any one of items I to 31, wherein the electrical contacts (130+, 130 ) are provided in the form of flexible printed-circuit boards (PCB).

[0148] 33. The aerosol generator component (10) according to any one of items 1 to 32, wherein the electrical contacts (130+, 130 ) comprise electroconductive copper layers, preferably equipped at least partially with a resistant top-layer, such as a gold-plating, to prevent oxidation and corrosion of the underlying copper-layers.

[0149] 34. The aerosol generator component (10) according to item 33, wherein at least the outer contact ends (133+, 133 ) of the electrical contacts (130+, 130 ) are equipped with a resistant top-layer, such as a gold-plating.

[0150] 35. The aerosol generator component (10) according to any one of items 1 to 34, wherein the electrical contacts (130+, 130 ) comprise inner connecting sections (131+, 131 ) located within the casing (100), and wherein the inner connecting sections (131+, 131 ), or optionally both the outer contact ends (133+, 133 ) and the inner connecting sections (131+, 131 ), are equipped with a resistant top-layer, such as a gold-plating.

[0151] 36. The aerosol generator component (10) according to any one of items I to 35, wherein the aerosol generator component (10), optionally the front frame unit (103) of the casing (100) or a sealing element attached to the front frame unit (103), is provided with contact-support pins (160a, 160b), at least one per outer connecting section (132+, 132 ), to provide structural support to the outer connecting sections (132+, 132 ) and their outer contact ends (133+, 133 ) and ensure reliable electric connection to the vibration generator when the aerosol generator component (10) is inserted in the vibrating mesh nebulizer (20).

[0152] 37. The aerosol generator component (10) according to item 36, wherein the contactsupport pins (160a, 160b) are made of a form-stable material, such as polypropylene (PP), acrylonitrile butadiene styrene (ABS), or the like, or alternatively other materials, such as liquid silicone rubber (LSR), thermoplastic elastomer (TPE), or similar, as long as they provide sufficient rigidity.

[0153] 38. The aerosol generator component (10) according to items 36 or 37, wherein the outer contact ends (133+, 133 ) of each outer connecting section (132+, 132 ) are shaped to fit onto, over, or around, the contact-support pins (160a, 160b), and are optionally affixed thereto, preferably without the need for soldering.

[0154] 39. The aerosol generator component (10) according to item 38, wherein the aerosol generator component (10), optionally the rear frame unit (104) of the casing (100), is further equipped with corresponding support-pin through-holes (161a, 161b) through which, upon and after assembly of the aerosol generator component (10), the contact-support pins (160a, 160b) along with the outer contact ends (133+, 133 ) are inserted in such a way that the outer contact ends (133+, 133 ) get pressed onto, over, or around, the contact-support pins (160a, 160b) and held in place by the inner perimeter of the support-pin through-holes (161a, 161b).

[0155] 40. The aerosol generator component (10) according to items 38 or 39, wherein the outer contact ends (133+, 133 ) of the electrical contacts (130+, 130 ) are glued to the contact-support pins (160a, 160b).

[0156] 41. The aerosol generator component (10) according to any one of items 36 to 40, wherein the outer contact ends (133+, 133 ) of the electrical contacts (130+, 130 ) are not soldered to the contact-support pins (160a, 160b).

[0157] 42. The aerosol generator component (10) according to items 36 to 41, wherein the contact-support pins (160a, 160b) do not comprise, nor require, additional metal clamps- or springs affixed - e.g., soldered - thereto.

[0158] 43. The aerosol generator component (10) according to any one of items 1 to 42, wherein when the aerosol generator component (10) is inserted in the vibrating mesh nebulizer (20), the vibrating mesh (120) is oriented vertically, or substantially vertically, and / or perpendicular to the surface of a liquid formulation (30) filled into the nebulizer’s reservoir (211). The aerosol generator component (10) according to any one of items 1 to 43, wherein the aerosol generator component (10) is intended for multiple-use. The aerosol generator component (10) according to any one of items 1 to 44, wherein the aerosol generator component (10) exhibits a small size of only about 35-45 mm height (e.g., about 40 mm), about 30-35 mm width (e.g., about 33 mm), and about 8-12 mm thickness (e.g., about 10 mm). A vibrating mesh nebulizer (20) comprising:

[0159] - a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized,

[0160] - a user interface component (220) with a user interface (221), such as a mouthpiece (222) or a facemask (223), from which a user can inhale the nebulized formulation in the form of an aerosol,

[0161] - a main body (240) comprising electronic components for the operation of the nebulizer (20), including a vibration generator capable of causing vibrations of the vibrating mesh (120), thereby nebulizing the liquid formulation (30) housed in the nebulizer’s reservoir (211), and

[0162] - the aerosol generator component (10) according to any one of items 1 to 45, the casing (100) of which houses the nebulizer’s vibrating mesh (120) and electrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with the vibration generator. The vibrating mesh nebulizer (20) according to item 46, wherein the nebulizer comprises a mouthpiece (222), and wherein the mouthpiece (222) is an integral part of the user interface component (220), thus reducing the number of components to be assembled by a user. The vibrating mesh nebulizer (20) according to item 46 or 47, wherein the reservoir component (210) and the user interface component (220) are provided in joint form, with the two components being connected via a first hinge (235), thus (further) reducing the number of components to be assembled by a user. The vibrating mesh nebulizer (20) according to any one of items 46 to 48, wherein the reservoir component (210) comprises a reservoir lid (213) to prevent spillage of the liquid formulation (30) from the reservoir (211). The vibrating mesh nebulizer (20) according to item 49, wherein:

[0163] - the reservoir component (210) and the reservoir lid (213) are provided in joint form, with the two components being connected via a second hinge (236), or

[0164] - the reservoir component (210), the reservoir lid (213), and the user interface component (220) are provided in joint form, with the three components being connected via a first hinge (235), thus (further) reducing the number of components to be assembled by a user. The vibrating mesh nebulizer (20) according to items 49, or 50, wherein the reservoir lid (213) is adapted to open automatically upon detaching the joint reservoir / user interface assembly (210, 220) from the nebulizer’s main body (240). The vibrating mesh nebulizer (20) according to any one of items 46 to 51, wherein the nebulizer is delivered to the user, e.g., upon purchase, in a pre-assembled form. The vibrating mesh nebulizer (20) according to any one of items 46 to 52, wherein the vibrating mesh (120) is not permanently affixed to, or provided as an integral part of, the reservoir component (210). The vibrating mesh nebulizer (20) according to any one of items 46 to 53, wherein the vibrating mesh (120) is brought in fluid connection with a fluid outlet opening (212) of the reservoir (211) only when the aerosol generator component (10) is inserted in the vibrating mesh nebulizer (20). The vibrating mesh nebulizer (20) according to item 54, wherein the fluid connection between the vibrating mesh (120) and the fluid outlet opening (212) of the reservoir (211) is provided in a leak-tight manner via a spout (146) comprised in the aerosol generator component (10). The vibrating mesh nebulizer (20) according to item 55, wherein the spout (146) is provided as a part of, optionally as an integral part of, a flow-control plate (141) which is positioned between front- and rear ends (101, 102) of the casing (100), and which is made of a flexible material, such as silicone (more specifically liquid silicone rubber; LSR), thermoplastic elastomer (TPE), or similar. I . The vibrating mesh nebulizer (20) according to item 56, wherein the spout (146) is shaped as a protrusion extending from the flow-control plate (141), and wherein the fluid outlet opening (212) of the reservoir (211) is shaped such as to receive the spout (146) therein. 58. The vibrating mesh nebulizer (20) according to any one of items 46 to 57, wherein the aerosol generator component (10) is positioned, optionally wedged / clamped, between the reservoir component (210) and the user interface component (220).

[0165] 59. The vibrating mesh nebulizer (20) according to any one of items 46 to 58, wherein a sealing element (170) is provided between a front end (101) of the casing (100) of the aerosol generator component (10) and the user interface component (220).

[0166] 60. The vibrating mesh nebulizer (20) according to any one of items 46 to 59, wherein the nebulizer is equipped with a pressure sensor (250), optionally a pressure sensor housed within the nebulizer’s main body (240), to allow for inhalation-triggered aerosol generation upon sensing an inhalation manoeuvre during use of the nebulizer.

Claims

1. CLAIMS1. An aerosol generator component (10) for a vibrating mesh nebulizer (20) comprising a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized, a vibrating mesh (120), a vibration generator capable of causing vibrations of the vibrating mesh (120), thereby nebulizing the liquid formulation (30) housed in the nebulizer’s reservoir (211), and a user interface component (220) with a user interface (221), such as a mouthpiece (222) or facemask (223), from which a user can inhale the nebulized formulation in the form of an aerosol, wherein:- the aerosol generator component (10) is provided as an exchangeable component of the vibrating mesh nebulizer (20),- the aerosol generator component (10) comprises a casing (100) which houses the vibrating mesh (120) and electrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with the vibration generator, characterized in that the casing (100) of the aerosol generator component (10) further houses a flow-control element (140) capable of limiting a flow rate of an air flow through said flow-control element (140) to a predefined target flow rate or target flow rate range.

2. The aerosol generator component (10) according to claim 1, wherein the casing (100) comprises a front end (101) facing towards the user interface (220), and a rear end (102) facing towards the reservoir (211), when the aerosol generator component (10), the user interface component (220), and the reservoir component (210) are assembled in the vibrating mesh nebulizer (20), wherein the casing (100) comprises- one or more inlet openings (105) at the rear end (102) for air flow to the flowcontrol element (140) of the aerosol generator component (10) during inhalations of a user,- one or more outlet openings (106) at the front end (101) for air flow from the flow-control element (140) of the aerosol generator component (10), and- a flow passage (110) formed inside and through the casing (100) between these inlet- and outlet-openings (105, 106), directing the air flow from the reservoir (211) towards the user interface (221);and wherein the flow-control element (140) comprises:- a flexible flap (142) inside the flow passage (110) that is movable in response to the inhalative air flow in a bending and / or tilting manner, and- a flap-stop element (144) providing an endpoint to this movement of the flexible flap (142).

3. The aerosol generator component (10) according to claim 2, wherein the flexible flap (142) and the flap-stop element (144) are adapted such that upon inhalation of a user, the flap (142) is bent and / or tilted in response to the inhalative air flow and pressed against the flap-stop element (144) in such a way that the one or more outlet openings (106) at the front end (101) of the casing (100), get partially blocked so as to limit a flow rate of an air flow through the flow-control element (140) to a predefined target value or target range.

4. The aerosol generator component (10) according to claims 2 or 3, wherein the flexible flap (142) is provided in a flow-control plate (141) that is positioned between the casing’s front- and rear ends (101, 102), optionally as an integral part of the flow-control plate (141).

5. The aerosol generator component (10) according to claim 4, wherein the flexible flap (142) is formed in the flow-control plate (141) by a slit (144) surrounding at least parts of the outer perimeter of the flexible flap (142), with the respective part of the perimeter not surrounded by the slit (143) functioning as a hinge securing the flexible flap (142) to the flow-control plate (141) and allowing its bending and / or tilting movement in response to an air flow; wherein optionally the flexible flap (142) is square-shaped, and the slit (144) is provided surrounding three of the four sides of the square, with the fourth side functioning as a hinge securing the flexible flap (142) to the flow-control plate (141) and allowing its bending and / or tilting movement in response to an air flow.

6. The aerosol generator component (10) according to any one of claims 4 or 5, further comprising a spout (146) for fluidly connecting, in a leak-tight manner, the aerosol generator component (10) to a fluid outlet opening (212) of the reservoir (211), wherein the spout (146) is optionally provided as a part of the flow-control plate (141).

7. The aerosol generator component (10) according to any one of claims 1 to 6, further comprising one or more pressure sensing duct(s) (147) for connecting the inner volume of the casing (100) with a pressure sensor (250) provided in the vibrating mesh nebulizer (20) so as to allow for inhalation-triggered aerosol generation upon sensing an inhalation manoeuvre during use of the nebulizer, wherein optionally the one or more pressure sensing duct(s) (147) are provided as part(s) of the flow-control plate (141).

8. The aerosol generator component (10) according to any one of claims 1 to 7, wherein the flow-control element (140) limits the flow rate to a predefined target of no more than 30 L / min during inhalation; and optionally to a predefined target range of about 12-30 L / min, or about 12-25 L / min, or about 15-20 L / min.

9. The aerosol generator component (10) according to any one of claims 1 to 8, the aerosol generator component (10) comprising:- a front frame unit (103) and a rear frame unit (104), forming the casing (100) when joined, and providing the casing’s front end (101) and rear end (102), respectively, and- a flow-control plate (141) positioned between the front frame unit (103) and the rear frame unit (104), wherein the vibrating mesh (120) and the electrical contacts (130+, 130 ) required to operate the vibrating mesh (120) are positioned between the flow-control plate (141) and the front frame unit (103); optionally wedged, or clamped, in place between the flow-control plate (141) and the front frame unit (103).

10. The aerosol generator component (10) according to claims 1 to 9, wherein the electrical contacts (130+, 130 ) comprise outer connecting sections (132+, 132 ) extending to and protruding from the outside of the casing (100) for electric connection of the vibrating mesh (120) with the nebulizer’s vibration generator, wherein each outer connecting section (132+, 132 ) is provided with an outer contact end (133+, 133 ), and wherein the aerosol generator component (10), optionally a front frame unit (103) of the casing (100) or a sealing element attached to the front frame unit (103), is provided with contact-support pins (160a, 160b), at least one per outer connecting section (132+, 132 ), to provide structural support to the outerconnecting sections (132+, 132 ) and their outer contact ends (133+, 133 ) and ensure reliable electric connection to the vibration generator when the aerosol generator component (10) is inserted in the vibrating mesh nebulizer (20).

11. The aerosol generator component (10) according to claim 10, wherein the outer contact ends (133+, 133 ) of each outer connecting section (132+, 132 ) are shaped to fit onto, over, or around, the contact-support pins (160a, 160b), and are optionally affixed thereto, preferably without the need for soldering.

12. The aerosol generator component (10) according to claims 10 or 11, wherein the aerosol generator component (10), optionally the rear frame unit (104) of the casing (100) or the flow-control plate (141), is further equipped with corresponding support-pin through-holes (161a, 161b) through which, upon and after assembly of the aerosol generator component (10), the contact-support pins (160a, 160b) along with the outer contact ends (133+, 133 ) are inserted in such a way that the outer contact ends (133+, 133 ) get pressed onto, over, or around, the contact-support pins (160a, 160b) and held in place by the inner perimeter of the support-pin through-holes (161a, 161b).

13. The aerosol generator component (10) according to any one of claims 1 to 12, wherein the aerosol generator component (10) exhibits a small size of only about 35-45 mm height, about 30-35 mm width, and about 8-12 mm thickness.

14. A vibrating mesh nebulizer (20) comprising:- a reservoir component (210) with a reservoir (211) for housing a liquid formulation (30) to be nebulized,- a user interface component (220) with a user interface (221), such as a mouthpiece (222) or a facemask (223), from which a user can inhale the nebulized formulation in the form of an aerosol,- a main body (240) comprising electronic components for the operation of the nebulizer (20), including a vibration generator capable of causing vibrations of the vibrating mesh (120), thereby nebulizing the liquid formulation (30) housed in the nebulizer’s reservoir (211), and- the aerosol generator component (10) according to any one of claims 1 to 13, the casing (100) of which houses the nebulizer’s vibrating mesh (120) andelectrical contacts (130+, 130 ) for electrically connecting the vibrating mesh (120) with the vibration generator.

15. The vibrating mesh nebulizer (20) according to claim 14, wherein the vibrating mesh (120) is not permanently affixed to, or provided as an integral part of, the reservoir component (210).

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