1. Field of the Invention
The present invention relates to a swirl nozzle, particularly for delivering or atomizing a liquid, preferably a medicament formulation or other fluid, having inlet channels and an outlet channel, the inlet channels extending transversely to the outlet channel, to a method of using the swirl nozzle for atomizing a liquid medicament formulation, and to methods of producing a swirl nozzle and an atomizer comprising a swirl nozzle.
2. Description of Related Art
When atomizing a liquid medicament formulation, the intention is to convert as precisely defined an amount of active substance as possible into an aerosol for inhalation. The aerosol should be characterised by a low mean value for the droplet size, while having a narrow droplet size distribution and a low pulse (low propagation rate).
The term “medicament formulation” according to the present invention extends beyond medicaments to include therapeutic agents or the like, particularly every kind of agent for inhalation or other use. However, the present invention is not restricted to the atomizing of agents for inhalation but may also be used, in particular, for cosmetic agents, agents for body or beauty care, agents for household use, such as air fresheners, polishes or the like, cleaning agents or agents for other purposes, particularly for delivering small amounts, although the description that follows is primarily directed to the preferred atomization of a medicament formulation for inhalation.
The term “liquid” is to be understood in a broad sense and includes, in particular, dispersions, suspensions, so-called solutions (mixtures of solutions and suspensions) or the like. The present invention can also be generally used for other fluids. However, the description that follows is directed primarily to the delivery of liquid.
By the term “aerosol” is meant, according to the present invention, a preferably cloud-like accumulation of a plurality of drops of the atomized liquid with preferably substantially undirected or wide spatial distribution of the directions of movement and preferably with drops traveling at low speeds, but it may also be, for example, a conical cloud of droplets with a primary direction corresponding to the main exit direction or exit pulse direction.
U.S. Pat. Nos. 5,435,884, and 5,951,882 and European Patent EP 0 970 751 B1 are directed to the manufacture of nozzles for vortex chambers. A flat, key-shaped vortex chamber is etched into a plate-shaped piece of material, or component, together with inlet channels opening tangentially into the vortex chamber, starting from a flat side. In addition, an outlet channel is etched through the thin base of the vortex chamber in the centre thereof. The inlet channels are connected at the inlet end to an annular supply channel which is also etched into the component. The component with this etched structure is covered by an inlet piece and installed in a carrier. These vortex chamber nozzles are not ideal for higher pressures and for delivering small amounts or for producing very fine droplets.
The objective of the present invention is to provide a swirl nozzle, a use of a swirl nozzle and methods of producing swirl nozzles and an atomizer, so as to enable simple nozzle construction and/or ease of manufacture, while still allowing very small amounts of liquid to be delivered and/or very fine atomizing to be achieved, in particular.
This objective is achieved as described below.
According to a first aspect of the present invention, the inlet channels open directly and/or tangentially or at an angle between tangentially and radially into the outlet channel. The vortex chamber used in the prior art is not required. This makes the construction particularly compact and simple. In addition, it allows a more robust structure which will withstand higher pressures, in particular, as there is no longer any need for a vortex chamber with a base which is thin so as to ensure a short length of outlet channel. Instead, it is possible to improve the reinforcement of the material and the support around the outlet channel.
By dispensing with a vortex chamber, the volume of liquid to be received by the nozzle is reduced substantially. This is advantageous, for example, when delivering medicament formulations if very small amounts have to be metered very accurately. Moreover, the smallest possible volumes in the swirl nozzle are advantageous, for example, in order to counteract possible bacterial growth in the medicament formulation in the swirl nozzle and/or contamination of the swirl nozzle caused by the precipitation of solids.
In order to atomize a liquid medicament formulation, the medicament formulation is passed through the proposed swirl nozzle under high pressure, so that the medicament formulation is atomized into an aerosol or a fine spray mist, more particularly immediately on leaving the outlet channel. The resultant cloud is released in a substantially conical shape, in particular.
According to another aspect of the present invention which can be implemented separately, the spray nozzle comprises, upstream of the inlet channels, a filter structure having smaller cross-sections of passage than the inlet channels. This again allows a very small and in particular microfine construction of the swirl nozzle and permits very fine atomization even with small amounts of liquid, as any particles contained in the liquid which is to be atomized and which would otherwise be liable to block the inlet channels or even the outlet channel can be filtered out. Accordingly, high operational reliability is achieved even with a swirl nozzle of very small dimensions.
A first proposed method of producing a swirl nozzle is characterised in that at least one inlet channel is formed on a flat side of a first plate-shaped component and an outlet channel is formed which extends into the component and is initially still closed off at one end. Then, the first component is connected to a second, preferably also plate-shaped component, so that the second component at least partially covers the flat side of the first channel section containing the inlet channel. Only when the two pieces of material have been joined together is the first component machined, particularly ground away on the flat side remote from the second component, thereby opening up the outlet channel on this side. The second component stabilizes the first component during the machining and thereafter. This provides a simple manner of producing relatively thin or small structures, particularly a short outlet channel, with high stability, while also obtaining a swirl nozzle which is resistant to high fluid pressures or other stresses.
A second proposed method of producing a swirl nozzle is characterised in that at least one inlet channel is formed in a first, preferably plate-shaped component starting from a flat side, in that the outlet channel is at least partially formed in a second, preferably plate-shaped component, starting from a flat side and in particular extending transversely thereof, and the two pieces of material are joined together, so that the second component at least partially covers the flat side of the first component comprising the inlet channel. This provides a simple way of manufacturing even very fine structures. The manufacture of the at least one inlet channel and of the outlet channel independently of one another makes it possible to optimize the manufacturing processes involved.
According to a preferred further feature, the outlet channel is formed, particularly by etching, on only one side of the second component, while open, before the pieces of material are joined together. Then, the two pieces of material are joined together for the first time so that the opening of the outlet channel faces towards the first component. Only then is the second component machined, particularly ground away, on the flat side remote from the component, thereby opening up the outlet channel on this side. The first component may accordingly stabilize the second component even during the machining and thereafter.
Further aspects, features, properties and advantages of the present invention will become apparent from the following description of preferred embodiments with reference to the accompanying drawings.
In the figures, the same reference numerals have been used for identical or similar parts, even though the corresponding description may be omitted.
The swirl nozzle 1 also has an outlet channel 3 which in
It is proposed that the inlet channels 2 preferably open directly, radially and/or tangentially into the outlet channel 3, but the inlet channels 2 may also open into the outlet channel 3 at an angle between tangentially and radially, preferably more tangentially, particularly preferably in an angular range of 25° starting from the tangential. Thus, in particular, no (additional) vortex chamber is provided as is conventional in the prior art. This allows the structure of the swirl nozzle 1 to be kept simple, compact and particularly robust, as will become apparent from the description to follow. The swirl nozzle 1 may also have further structures upstream of the inlet channels 2; these therefore do not have to form an external inlet for the swirl nozzle 1 but are simply supply lines to the outlet channel 3.
The swirl nozzle 1 serves to deliver and, in particular, atomize a fluid, such as a liquid (not shown), particularly, a medicament formulation or the like. With the structure or arrangement shown in
The inlets of the inlet channels 2 are preferably at a spacing of preferably 50 to 300 μm, especially 90 to 120 μm, from the central axis M of the outlet channel 3. In particular, the inlets are uniformly arranged in a circle around the outlet channel 3 or its central axis M.
The inlet channels 2 extend towards the outlet channel 3 essentially in a radial or curved configuration, preferably with a curvature that is constant or that increases continuously towards the outlet channel 3, and/or with a decreasing channel cross-section. The direction of curvature of the inlet channels 2 corresponds to the direction of swirl of the swirl nozzle 1 or of the liquid (not shown) in the outlet channel 3.
Particularly preferably, the inlet channels 2 are curved at least substantially according to the following formula, which gives the shape of the sidewalls of the inlet channels 2 in polar coordinates (r=radius, W=angle):
wherein RA is the outlet radius and RE is the inlet radius of the inlet channel 2 and WA and WE are the corresponding angles.
The inlet channels 2 preferably all become narrower toward the outlet channel 3, in particular, by at least a factor based on the cross-sectional area through which fluid can flow.
The inlet channels 2 are preferably formed as depressions, particularly between guide means, partition walls, elevated sections 4 or the like. In the embodiment shown, the inlet channels 2 or the elevated sections 4 which form or define them are at least substantially crescent-shaped or half moon-shaped.
The depth of the inlet channels 2 is preferably 5 to 35 μm in each case. The outlets of the inlet channels 2 preferably each have a width of from 2 to 30 μm, particularly 10 to 20 μm.
The outlets of the inlet channels 2 are preferably each at a spacing from the central axis M of the outlet channel 3 which corresponds to 1.1 to 1.5 times the diameter of the outlet channel 3 and/or at least 1 μm. It can be inferred from the schematic sections shown in
The outlet channel 3 is preferably at least substantially cylindrical. This is true in particular of the above-mentioned inlet region as well. The outlet channel 3 preferably has an at least substantially constant cross-section. The entire (slight) enlargement in the inlet region is not regarded as essential in this sense. However, it is also possible for the outlet channel 3 to have a slight conicity over its length and/or in the inlet region or outlet region, caused particularly by the manufacturing method.
The diameter of the outlet channel 3 is preferably 5 to 100 μm, in particular 25 to 45 μm. The length of the outlet channel 3 is preferably 10 to 100 μm, particularly 25 to 45 μm, and/or preferably corresponds to 0.5 to 2 times the diameter of the outlet channel 3.
The swirl nozzle 1 preferably comprises, upstream of the inlet channels 2, a filter structure which in the embodiment shown is formed by elevated sections 5, and in particular. comprises passage cross-sections that are smaller than the inlet channels 2. The filter structure, which is shown not to scale in
With regard to the filter structure, it is pointed out that it has a plurality of parallel flow channels with the smaller cross-section, and therefore, preferably, substantially more flow paths than inlet channels 2 are provided, with the result that the flow resistance of the filter structure is preferably less than the flow resistance of the parallel inlet channels 2. This also ensures satisfactory operation even when individual flow paths of the filter structure are blocked by particles, for example.
The inlet channels 2 are attached at the inlet end to a common supply channel 6 which serves to distribute and supply the liquid which is to be atomized. In the embodiment shown, the supply channel 6 is preferably annular (cf.
The preferred production of the proposed swirl nozzle 1 described above will now be explained in more detail. However, the manufacturing methods described may theoretically also be used with other swirl nozzles, possibly even ones provided with a vortex chamber.
The inlet channels 2 and the outlet channel 3—preferably also the common supply channel 6 and/or the filter structure—are preferably formed in a one-piece or multipart nozzle body 7. Two proposed methods and embodiments are described more fully hereinafter.
The nozzle body 7 is made in two parts in the first embodiment. It comprises a first, preferably plate-like component 8 and a second, preferably also plate-like component 9.
In the first embodiment, first of all, the desired structures are formed at least partly and, in particular, at least substantially completely in the first component 8 starting from a flat side, particularly by etching, as described, for example, in the prior art mentioned hereinbefore. In particular, at least one inlet channel 2 and preferably all of the inlet channels 2 and the outlet channel 3 are recessed in the first component 8, starting from the flat side, and more particularly, are formed as depressions by etching. The inlet channels 2 extend parallel to the flat side in particular. The outlet channel 3 extends at right angles to the flat side and is initially recessed or formed only as a recess closed at one end (blind bore).
In addition, all the other desired structures or the like can be simultaneously formed in the first component 8, especially the common supply channel 6, the filter structure and/or other feed lines or the like.
The first component 8 preferably is made of silicon or some other suitable material.
Then, the first component 8 is joined to the second component 9, so that the second component 9 at least partially covers the flat side of the first component 8 which has the inlet channel or channels 2, so as to form the desired sealed hollow structures of the swirl nozzle 1.
The components 8, 9 are joined together, in particular, by so-called bonding or welding. However, theoretically any other suitable method of attachment or a sandwich construction is possible.
In a particularly preferred alternative embodiment, a plate member (not shown), particularly a silicon wafer is used, from which a plurality of first components 8 are used for a plurality of swirl nozzles 1. Before being broken down into individual components 8 or swirl nozzles 1, preferably the structures, especially depressions or recesses, are initially produced starting from a flat side of the plate member for the plurality of first components 8 or swirl nozzles 1. In particular, this is done by a treatment or etching of fine structures as is conventional in semiconductor manufacture, and consequently reference is hereby made in this respect to the prior art relating to the etching of silicon or the like.
Particularly preferably, the second component 9, like the first component 8, is made from a plate member which is broken down or separated into a plurality of second components 9. To produce the first components 8, it is particularly preferable to use a silicon wafer as the plate member, as explained above. The plate member used to produce the second components 9 may also be a silicon wafer or some other kind of wafer, a sheet of glass or the like.
If a plate member is used to produce both the first components 8 and the second components 9, it is particularly preferable to join the plate members together before they are broken down into the individual components 8, 9. This makes assembly and positioning substantially easier.
In order to assist with the positioning of the plate members relative to one another, it is particularly preferable to use plate members of the same size and shape. For example, if a disc-shaped silicon wafer is used to form the first components 8, it is recommended to use a disc-shaped plate member of the same size, e.g., made of glass, to form the second components 9. Obviously, other plate shapes may be used and joined together, such as rectangular plate members, for example. Circular discs are particularly recommended, however, as wafers of silicon or other materials are obtainable particularly cheaply. It should be noted that the plate members which are joined together may, if required, be of different shapes or sizes.
After the two components 8, 9 or the plate members which form them have been joined together, either before or after the separation or breaking down of the plate members into the individual components 8, 9 or into the swirl nozzles 1, the first component 8 or the corresponding plate member is machined, particularly ground away on the flat side remote from the second component 9 or the plate member thereof. In this way, the thickness of the first component 8 is substantially reduced. For a conventional silicon wafer, the initial thickness D1 is usually about 600 to 700 μm. This thickness D1 is substantially reduced, for example, to a thickness D2 of about 150 μm or less. This results in the opening up of the outlet channels 3, which were initially closed on one side, from the machining side. The length of the outlet channels 3 is thus determined by the thickness D2 to which the first component 8 or the plate member forming the components 8 is machined.
The method of manufacture described above makes it easy to produce the first component 8 very thinly and at the same time achieve very high stability and resistance for the swirl nozzle 1, particularly to high fluid pressures, as the second component 9 forms a unified whole with the first component 8 and ensures the required stability or stabilization of the first component 8, even when it is very thin.
Moreover, the fact that there is preferably no vortex chamber between the inlet channels 2 and the outlet channel 3 also contributes to the high stability or load-bearing capacity of the first component 8, even when it has a very low thickness D2. Instead, the elevated sections 4 or other webs or the like which delimit or define the inlet channels 2 may extend directly to the outlet channel 3, which has a substantially smaller diameter than a normal vortex chamber. Accordingly, the section of the first component 8 which is unsupported in this region is essentially reduced to the diameter of the outlet channel 3.
The plate members joined together are finally broken down into the preferably rectangular or square or optionally round components 8, 9, respectively, i.e., into the finished swirl nozzles, particularly by sawing or other machining.
A second embodiment of the proposed swirl nozzle 1 and a second embodiment of the preferred method of production will now be described with reference to
In the second embodiment, the outlet channel 3 is formed at least partially, particularly at least essentially, in the second component 9. The remainder of the structure of the swirl nozzle 1, particularly at least one inlet channel 2, is formed in the first component 8. Consequently, it is possible to produce the outlet channel 3 at least largely independently of the manufacture of the remaining structure of the swirl nozzle 1, particularly the inlet region of the swirl nozzle 1.
In the second embodiment, before the two components 8, 9 are joined together, the outlet channel 3 is at least partly recessed in the second component 9, starting from a flat side and extending in particular at right-angles to the flat side, in the form of a recess, preferably by etching. However, it is theoretically also possible to form or recess the outlet channel 3 only after the two components 8, 9 have been joined together.
Particularly preferably, the outlet channel 3 is recessed initially only on one side, particularly by etching, in the second component 9 while it is open, before the two components 8 and 9 are joined together, i.e. as a blind bore as in the first embodiment, but in this case in the second component 9 and not in the first component 8.
Optionally, the surfaces can then be ground, polished or otherwise thinned, e.g. by spin etching. Then the two components 8 and 9 are joined together. Preferably, once again, this is done by joining together the plate members, each of which forms a plurality of components 8 or 9.
Finally, the second component 9 or the plate member forming the second components 9 is then thinned, particularly ground, on the flat side remote from the first component 8. This causes the outlet channel 3 or outlet channels 3 to be opened up from the machining side. The machining and/or opening may, however, also be carried out before the components are joined together.
The thinning of the second component 9 or of the corresponding plate member is preferably done to a thickness D2 as explained in the first embodiment, with the result that the remarks made previously apply here.
In the second embodiment, silicon is preferably used for the second component 9 as well. In particular, a silicon wafer or the like is used as a plate member for forming the second components 9.
The proposed manufacturing methods described are not restricted to the manufacture of the swirl nozzle 1 proposed or shown but may also be used generally for other swirl nozzles 1 and also for vortex chamber nozzles, i.e., swirl nozzles with vortex chambers.
During manufacture, etching is preferably used to work on the material, particularly to thin it. In this way, very precise, very fine structures can be obtained, particularly recesses, channels and the like, most preferably in the μm range of 50 μm, particularly 30 μm or less. However, in addition or alternatively, other methods of machining material and/or shaping, such as laser treatment, mechanical treatment, casting and/or embossing may also be used.
Preferably, the swirl nozzle 1 is at least substantially flat and/or plate-shaped. The main direction of flow or the main supply direction of the liquid (not shown) runs essentially in the main direction of extent, corresponding in particular to the planes of the plates of the components 8, 9 or the joined-together surfaces of the components 8, 9 or a plane parallel thereto. The outlet channel 3 preferably extends transversely, especially perpendicularly, to the main plane of extent or plane of the plate of the spray nozzle 1, to the main inflow direction of the liquid and/or to the main extent of the filter structure. The main direction of extent of the outlet channel 3 and the main direction of delivery of the swirl nozzle 1 preferably extend in the direction of the central axis M.
The inlet channels 2, the supply channel 6, the filter structure and/or other inflow regions for the liquid formed in the swirl nozzle 1 are preferably at least substantially arranged in a common plane and most preferably are formed only on one side, in particular, starting from a flat side or surface of the component 8.
Theoretically, a plurality of outlet channels 3 or even a plurality of swirl nozzles 1 may be formed on a component 8, 9. The structures are then adapted accordingly.
Individual features and aspects of the various embodiments may also be combined with one another as desired.
The proposed swirl nozzle 1 is most preferably used to atomize a liquid medicament formulation, the medicament formulation being passed through the swirl nozzle 1 under high pressure, so that the medicament formulation emerging from the outlet channel 3 is atomized into an aerosol (not shown), more particularly having particles or droplets with a mean diameter of less than 10 μm, preferably 1 to 7 μm, particularly substantially 5 μm or less.
Preferably, the proposed swirl nozzle 1 is used in an atomizer 10 which will be described hereinafter. In particular, the swirl nozzle 1 serves to achieve very good or fine atomizing while at the same time achieving a relatively large flow volume and/or at relatively low pressure.
The swirl nozzle 1 is preferably installed in the atomizer 10, particularly a holder 11. Thus, a nozzle arrangement 22 is obtained.
The atomizer 10 is used to atomize a fluid 12, particularly a highly effective medicament, a medicament formulation or the like. When the fluid 2, which is preferably a liquid, especially a medicament, is atomized, an aerosol 24 is formed which can be breathed in or inhaled by a user (not shown). Normally, the inhalation is carried out at least once a day, more particularly several times a day, preferably at prescribed intervals, depending on the patient's condition.
The atomizer 10 has an insertable and preferably replaceable container 13 containing the fluid 12. The container 13 thus constitutes a reservoir for the fluid 2 which is to be atomized. Preferably, the container 13 contains a sufficient quantity of fluid 12 or active substance to be able to provide up to 300 dosage units, for example, up to 300 sprays or applications.
The container 13 is substantially cylindrical or cartridge-like and can be inserted in the atomizer 10 from below, after the atomizer has been opened, and can optionally be replaced. The container is of rigid construction, the fluid 12 preferably being held in a fluid chamber 14 in the container 13, consisting of a collapsible bag.
The atomizer 10 also comprises a conveying device, preferably a pressure generator 15 for conveying and atomizing the fluid 12, particularly in a predetermined, optionally adjustable metered dosage.
The atomizer 10 or pressure generator 15 has a holding device 16 for the container 13, an associated drive spring 17, which is shown only in part, having a locking element 18 which can be manually operated to release it, a conveying tube 19 preferably in the form of a thick-walled capillary with an optional valve, particularly a non-return valve 20, a pressure chamber 21 and the nozzle arrangement 22 in the region of a mouthpiece 23. The container 13 is fixed in the atomizer 10 by means of the holding device 16, more particularly by engagement, such that the conveying tube 19 is immersed in the container 13. The holding device 16 may be constructed so that the container 13 can be released and replaced.
During the axial tensioning of the drive spring 17 the holding device 16 is moved downwards in the drawings together with the container 13 and conveying tube 19, and fluid 12 is sucked out of the container 13 through the non-return valve 20 into the pressure chamber 21 of the pressure generator 15.
During the subsequent release after actuation of the locking element 18, the fluid 12 in the pressure chamber 21 is put under pressure, by moving the conveying tube 19 with its now closed non-return valve 20 upwards again by releasing the drive spring 17 and it now acts as a pressure ram or piston. This pressure forces the fluid 12 out through the nozzle 22, where it is atomized into an aerosol 24, as shown in
A user or patient (not shown) can inhale the aerosol 24, while a supply of air can preferably be sucked into the mouthpiece 23 through at least one air inlet opening 25.
The atomizer 10 has an upper housing part 26 and an inner part 27 which is rotatable relative to it (
The housing part 28 can be rotated relative to the upper housing part 26, carrying with it the lower part 27b of the inner part 27 which is lower down in the drawing. As a result the drive spring 17 is tensioned in the axial direction by means of a gear (not shown) acting on the holding device 16. During tensioning the container 13 is moved axially downwards until the container 13 assumes an end position as shown in
It should be mentioned in general that, in the proposed atomizer 10, the container 13 can preferably be inserted into the atomizer 10, i.e., can be installed therein. Consequently, the container 13 is preferably a separate component. However, the container 13 or fluid chamber 14 may theoretically also be formed directly by the atomizer 10 or part of the atomizer 10 or in some other way integrated in the atomizer 10 or may be connectable thereto.
By contrast with free-standing equipment or the like, the proposed atomizer 10 is preferably constructed to be portable and/or manually operated, and in particular, it is a movable hand-held device.
It is particularly preferable for atomization to take place on each actuation for a period of about 1 to 2 breaths. However, theoretically, it is also possible for the atomization to be longer-lasting or continuous.
Particularly preferably, the atomizer 10 is constructed as an inhaler, especially for medicinal aerosol treatment. Alternatively, however, the atomizer 10 may also be designed for other purposes, and may preferably be used to atomize a cosmetic liquid and particularly as a perfume atomizer. The container 13 accordingly contains, for example, a medicament formulation or a cosmetic liquid such as perfume or the like.
Examples of atomizers of the type in which the swirl nozzle of the present application is usable can be found in commonly-owned U.S. Patent Application Publication Nos. 2007/0029475 and 2006/0027233, among others.
However, the proposed solution may be used not only in the atomizer 10 specifically described here but also in other atomizers or inhalers, e.g., powder inhalers or so-called metered dose inhalers.
The atomizing of the fluid 12 through the swirl nozzle 1 is preferably carried out at a pressure of about 0.1 to 35 MPa, in particular, about 0.5 to 20 MPa, and/or with a flow volume of about 1 to 300 μl/s, in particular about 5 to 50 μl/s.
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