The present application is a U.S. National Phase Application pursuant to 35 U.S.C. § 371 of International Application No. PCT/EP2018/083702 filed Dec. 5, 2018, which claims priority to European Patent Application No. 17209321.3 filed Dec. 21, 2017. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.
The present disclosure generally relates to a spray nozzle chip, in particular for a medicament delivery device.
A nozzle device may be configured to atomise a fluid, i.e. to make an aerosol of the fluid. A nozzle device of this type may comprise a sieve membrane provided for filtering out any undesired larger particles contained in the fluid to be atomised. The nozzle device may also include a nozzle membrane with one or more orifices. The nozzle membrane and the sieve membrane are configured to be in fluid communication. In the process of atomisation, the fluid first passes the sieve membrane. The filtered fluid subsequently passes through the one or more orifices of the nozzle membrane, whereby the fluid is atomised.
An example of a spray device is disclosed in WO 2017/095220 A1. The spray device comprises a spray nozzle body and a substantially planar membrane suspended over a nozzle cavity to generate microjets, in particular for pharmaceutical applications. The nozzle body contains a microbial barrier in form of a microvalve between a fluid supply channel and the nozzle cavity.
The nozzle cavity provides a risk with respect to microbial safety of the spray device, because the cavity is in contact with the outside environment. Additionally, the configuration disclosed in WO 2017/095220 A1 provides a single fluid flow to a plurality of nozzle orifices distributed circularly around the microvalve. The force required to open the valve is provided only in the valve seat, which covers only part of the membrane, thus requiring a relatively high fluid pressure during spraying to operate as intended.
WO 2016/203225 shows a nozzle assembly having a valve and filter functionality adapted for larger dimensions and higher pressures, which allows the use of other materials and processes than available for the present disclosure.
In view of the above, a general object of the present disclosure is to provide a spray nozzle chip which solves or at least mitigates problems of the prior art.
There is hence according to a first aspect of the present disclosure provided a spray nozzle chip, comprising: a first layer provided with a first layer orifice, a mechanically flexible nozzle layer provided with a nozzle orifice, the spray nozzle chip having a valve functionality obtained by movement of the nozzle layer relative to the first layer due to pressure changes, wherein the nozzle orifice is closed when the nozzle layer is in a default non-pressurised state and wherein the nozzle orifice is opened and set in fluid communication with the first layer orifice when the nozzle layer is deformed due to pressure during a spraying operation.
The relative movement between the first layer and the nozzle layer provides a closure of the nozzle orifice when the nozzle layer is in the default non-pressurised state. Since the nozzle orifice is closed in this state, the exposure to the outside environment is minimised with only the nozzle orifice being exposed. In WO 2017/095220 A1, the nozzle cavity below the nozzle orifice is also exposed to the outside world. The nozzle cavity will thereby be contaminated by drying fluid. If reused, the fluid has to pass the contaminated nozzle cavity. Hereto, the present spray nozzle chip may provide a better microbial protection.
The nozzle orifice and the first layer orifices diameters may for example be of the order of micrometres. More specifically, the nozzle orifice and/or the first layer orifices may have a diameter of 0.1-50 μm, or 0.1-25 μm, or 0.1-10 μm, or 0.1-5 μm, or 0.5-3 μm, or 0.5-1.5 μm. The length or depth of the nozzle orifice and/or the first layer orifices may for example be between 0.2-20 μm, or 0.2-10 μm, or 0.2-5 μm or 0.5-3 μm, or 0.5-2 μm.
The fluid may be a liquid, for example a liquid medicament.
According to one embodiment the nozzle orifice has a nozzle orifice perimeter and wherein the nozzle orifice and the nozzle orifice perimeter are covered in the default non-pressurised state due to cooperation between the nozzle layer and the first layer.
The nozzle orifice may be arranged symmetrically with respect to a fluid supply orifice causing the ventilation functionality in the region where the nozzle layer is deformed the most. This is where the lifting action is the greatest. The lifting force thus acts on a majority of the nozzle layer, in contrast to WO 2017/095220 A1, where the lifting action is limited to the central region of the membrane layer, where the microvalve is located. The same amount of nozzle layer displacement during a spraying operation opens the nozzle orifice more than is the case in WO 2017/095220. Lower pressure is hence necessary to obtain the necessary opening for fluid spraying.
According to one embodiment the nozzle orifice perimeter is in contact with the first layer in the default non-pressurised state to thereby close the nozzle orifice. The entire nozzle orifice perimeter may be in contact with the first layer during the default non-pressurised state. The contact with the first layer may be direct or indirect.
If the nozzle layer comprises a plurality of nozzle orifices, preferably each nozzle orifice is individually closed when the nozzle layer is in the default non-pressurised state and each nozzle orifice is opened and set in communication with the first layer orifice when the nozzle layer is deformed due to pressure during a spraying operation.
One embodiment comprises a sealing layer configured to seal the nozzle orifice before initial use of the spray nozzle chip, the sealing layer being configured to rupture when the nozzle layer is deformed due to applied pressure during a spraying operation. The sealing layer could be hermetic or non-hermetic, e.g. providing only a moisture, fluid or particle seal, or combinations thereof. By hermetically sealing the nozzle orifice before initial use, a medicament delivery device comprising the spray nozzle chip may be stored for a longer period of time than is possible today. Furthermore, it could enable the reuse of the spray nozzle chip for medical drug delivery.
According to one embodiment the sealing layer is antibacterial. The storage time may thereby be even further increased.
According to one embodiment the sealing layer comprises silver and/or a hydrophobic component. By using a hydrophobic component in the sealing layer, fluid droplets will be repelled from the sealing layer also after the hermetic sealing layer has ruptured. The risk of microbial growth may thereby be reduced. Additionally, the risk that the nozzle orifice becomes occluded is also reduced.
According to one embodiment the nozzle layer is mechanically more flexible than the first layer.
According to one embodiment each of the first layer and the nozzle layer is a membrane layer.
According to one embodiment the first layer is generally parallel with the nozzle layer.
The first layer may have a first layer inner surface and the nozzle layer may have a nozzle layer inner surface facing the first layer inner surface. The first layer inner surface and the nozzle layer inner surface may be configured to be in contact along essentially their entire respective surface areas when the nozzle layer is in the default non-pressurised state. In this case, portion of or the entire surface of one or both of the nozzle layer inner surface and the first layer inner surface may be geometrically or chemically modified so that they do not stick or attach to each other when in direct contact.
According to one embodiment the spray nozzle chip may comprise a support layer provided between a portion of the first layer and the nozzle layer to distance the nozzle layer from the first layer. The support layer may be in the order of Angstrom. The support layer may be a thin film layer.
According to one embodiment the nozzle orifice has a nozzle orifice perimeter, and the nozzle layer has an internal built-in stress that presses the nozzle layer to the first layer in the default non-pressurised state to thereby cover the nozzle orifice and the nozzle orifice perimeter. The nozzle layer may hence close the nozzle orifice as it is pressed against the first layer due to the internal stress in the default non-pressurised state, i.e. when the fluid is not pressurised. This may provide enhanced closing of the nozzle orifice when not in use. The built-in stress in the nozzle layer may for example be obtained by a bimorph structure or induced residual stress during manufacturing.
According to one embodiment one of the first layer and the nozzle layer has a protruding structure that encircles the perimeter of the nozzle orifice and provides a sealing pressure to close the nozzle orifice in the default non-pressurised state.
One embodiment comprises a substrate supporting the first layer, which substrate is provided with a fluid supply orifice configured to supply fluid to the first layer orifice.
The nozzle orifice may be centred with respect to the fluid supply orifice. The nozzle layer will thereby be deformed, or lifted, relative to the first layer maximally in the region of the nozzle orifice. Alternatively, the substrate may be provided with a plurality of fluid supply orifices and the nozzle orifice may be aligned with a separating wall between the fluid supply orifices, in the axial direction of the spray nozzle chip.
According to one embodiment the cross-sectional area of the first layer orifice is smaller than the cross-sectional area of the nozzle orifice.
According to one embodiment the first layer is a sieve layer comprising a plurality of first layer orifices configured to be in communication with the nozzle orifice when the nozzle layer is deformed due to pressure during a spraying operation.
The number of first layer orifices may be larger than the number of nozzle orifice(s). A lower pressure drop over the first layer may thereby be obtained.
The first layer orifice area formed by all the first layer orifices is preferably larger than the nozzle orifice area formed by all the nozzle orifice(s).
There is according to a second aspect of the present disclosure provided a medicament delivery device comprising a spray nozzle chip according to the first aspect.
According to one embodiment the medicament delivery device is an inhaler or an eye dispenser.
There is according to a third aspect of the present disclosure provided a method of manufacturing a spray nozzle chip according to the first aspect, wherein the method comprises: performing a first deposition onto a substrate to obtain a first layer, providing the first layer with a first layer orifice, performing a third deposition onto the first layer to obtain a nozzle layer, providing the nozzle layer with a nozzle orifice, and providing a fluid supply orifice in the substrate, the fluid supply orifice being set in fluid connection with the first layer orifice.
The first layer and the nozzle layer may for example be bonded together using fusion bonding, adhesive bonding, eutectic bonding, surface activated bonding, plasma activated bonding, etc. The bonding can be made selectively to enable the valve functionality of the spray nozzle chip. Hereto, the bonding is typically made in lateral regions of the first layer and the nozzle layer, usually in regions aligned with the substrate and distanced from the region which comprises the nozzle orifice and the first layer orifice(s).
One embodiment comprises performing a fourth deposition onto the nozzle layer to obtain a sealing layer, before providing a fluid supply orifice in the substrate.
According to one embodiment the fluid supply orifice may be provided in the substrate by means of etching.
One embodiment comprises performing a second deposition onto the first layer to obtain a support layer, after the first layer has been provided with a first layer orifice and before the third deposition. The support layer may for example form an intermediate, adhesive or eutectic bonding layer.
One embodiment may comprise creating a separation or distancing of the first layer and the nozzle layer by removing a portion of the support layer. The support layer may thus be undercut. The undercutting may for example be obtained using wet or dry etching.
Another method of manufacturing a spray nozzle chip according to the first aspect comprises: providing a first substrate with a first layer with first layer orifices, providing a second substrate with a nozzle layer with nozzle layer orifices, and transferring the nozzle layer onto the first layer to obtain the spray nozzle chip.
Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to “a/an/the element, apparatus, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc.”, unless explicitly stated otherwise.
The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:
The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like elements throughout the description.
The exemplified spray nozzle chip 1 comprises a substrate 3 having a fluid supply orifice 3a, which extends through the substrate 3. The substrate 3 may for example be made of a ceramic material such as silicon. The spray nozzle chip 1 furthermore comprises a first layer 7 and a nozzle layer 9. The nozzle layer 9 is mechanically flexible. In particular, it is mechanically more flexible than the first layer 7. According to the example, the first layer 7 is a membrane layer. The nozzle layer 9 is a membrane layer.
In
The first layer 7 is arranged on the substrate 3. The nozzle layer 9 is arranged on the first layer 7. In the present example, the spray nozzle chip 1 comprises a support layer, or intermediate layer, 11 configured to support the nozzle layer 9. The support layer 11 may be a thin film layer. The support layer 11 is arranged between a portion of the first layer 7 and the nozzle layer 9. The support layer 11 forms the attachment points of the nozzle layer 9, i.e. the nozzle layer 9 is attached to the support layer 11. Alternatively, the nozzle layer could be arranged directly on the first layer. In this case, it would be advantageous to modify the surface of at least one of the nozzle layer and the first layer so that they do not stick or attach to each other when the nozzle layer is to be deformed during a spraying operation.
The first layer 7 may be a sieve layer or filter layer. The first layer 7 comprises a plurality of first orifices 7a. The nozzle layer 9 comprises a nozzle orifice 9a. The nozzle orifice 9a has a nozzle orifice perimeter 9b. The nozzle orifice perimeter 9b discussed herein is the one which faces the underlying first layer 7.
Each first orifice 7a is smaller than or equal in size to the nozzle orifice 9a. In the former case, the cross-sectional area of any of the first orifices 7a is smaller than the cross-sectional area of the nozzle orifice 9a. The fluid supply orifice 3a has a larger cross-sectional area than the total cross-sectional area of the first orifices 7a. In the present example which comprises the support layer 11, the support layer 11 has a support layer orifice which has a larger cross-sectional area than the fluid supply orifice 3a. This does however not need to be the case.
The first orifices 7a and the nozzle orifice 9a are aligned with the fluid supply orifice 3a of the substrate 3. The fluid supply orifice 3a has a central axis A and the first orifices 7a and the nozzle orifice 9a all extend parallel with the central axis A. The first orifices 7a are arranged downstream of the fluid supply orifice 3a and the nozzle orifice 9a is arranged downstream of the first orifices 7a. The nozzle orifice 9a is in a direction parallel with the central axis A arranged aligned with a continuous surface of the first layer 7. Hereto, the nozzle orifice 9a is not aligned with any of the first orifices 7a. Although this is not shown in the schematic illustration in
In the present example, the nozzle orifice 9a is intersected by a plane containing the central axis A. This plane may be centralised relative to the nozzle orifice 9a. The nozzle orifice 9a may be centralised relative to the fluid supply orifice 3a.
After having passed the first layer orifices 7a the fluid F flows towards the nozzle orifice 9a. The fluid F exits the spray nozzle chip 1 through nozzle orifice 9a. Due to the aperture size of the nozzle orifice 9a and the pressure applied to the fluid, the exiting fluid jet breaks up into droplets 13, e.g. by Rayleigh breakup. Fluid F exiting through multiple nozzle orifices 9a forms an aerosol which may be inhaled, or applied as an eye spray, by a user. Once the spraying operation is completed and the pressure subsides, the nozzle layer 9 returns to its default non-pressurised state. The nozzle orifice 9a will thus again become closed.
As can be understood from the above, a plurality of first orifices 7a serves the nozzle orifice 9a. In particular, fluid F from a plurality of first orifices 7a serves the nozzle orifice 9a. For example, all of the first orifices 7a may serve a single nozzle orifice 9a. Further, multiple nozzle orifices 9a may be formed in the nozzle layer 9, but the number of first orifices 7a is always significantly greater than the number of nozzle orifices 9a.
The sealing layer 15 may be antibacterial. Hereto, the sealing layer 15 may for example comprise silver, or consist of silver. Alternatively, or additionally, the sealing layer 15 may comprise a hydrophobic component for repelling a fluid F.
When initially used, the pressure provided by the fluid F causes the nozzle layer 9 to flex away from the first layer 7 and the sealing layer 15 to rupture, as shown in
In addition to the configuration shown in
An example of manufacturing a spray nozzle chip 1, 1-1, 1-2 will now be described with reference to
In a first step a first deposition onto the substrate 3 is performed to obtain the first layer 7. Any material used in thin film depositions may be used as substrate, for example metals, silicon nitride, silicon, silicon dioxide. The first layer orifices 7a may be obtained using for example photolithography by providing a suitable patterned photoresist and etching the pattern of first layer orifices 7a into the first layer 7 using for instance reactive ion etching. The photoresist may be removed after the patterning of the first layer 7 has been completed.
A second deposition, onto the first layer 7 to obtain the support layer 11 may then be performed.
A third deposition, onto the support layer 11, is performed to obtain the nozzle layer 9. The bonding between the nozzle layer 9 and the first layer 7, via the support layer 11, may for example be via adhesive bonding or eutectic bonding. Next, the nozzle layer 9 is patterned to obtain the nozzle orifice 9a. The nozzle layer 9 may for example be patterned using photolithography by providing a suitable patterned photoresist and etching the pattern of the nozzle orifice 9a into the nozzle layer 9 using for instance reactive ion etching. The photoresist may be removed after the patterning of the nozzle layer 9 has been completed. The result of the above steps is depicted in
Next, as shown in
Turning now to
The support layer 11 is finally further undercut to free all of the first layer orifices 7a.
In a manufacturing variation concerning the depositions, as shown in
In any example herein, there may optionally be provided a silicon oxide layer between the first layer and the substrate.
The spray nozzle chip 1, 1-1, 1-2 may be used in medical applications. For instance, the spray nozzle chip 1, 1-1, 1-2 may be provided in a medicament delivery device such as an inhaler or an eye dispenser.
The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.
Number | Date | Country | Kind |
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17209321 | Dec 2017 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2018/083702 | 12/5/2018 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2019/121025 | 6/27/2019 | WO | A |
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Number | Date | Country | |
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20200385201 A1 | Dec 2020 | US |