Spray nozzle chip and a medicament delivery device comprising the same

Abstract

A spray nozzle chip is presented having: 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, and wherein the spray nozzle chip further has a sealing layer configured to rupture when the nozzle layer is deformed due to applied pressure during a spraying operation.

Claims

1. A spray nozzle chip comprising: a first layer provided with a first layer orifice; and a mechanically flexible nozzle layer positioned to directly face the first layer and is provided with a nozzle orifice, wherein the nozzle layer bears against the first layer when in a default non-pressurized state, wherein the spray nozzle chip having a valve functionality obtained by a flexing 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 the default non-pressurized 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, and wherein the spray nozzle chip further comprises a sealing layer that seals the nozzle orifice before initial use of the spray nozzle chip, where the sealing layer is ruptured when the nozzle layer is deformed due to applied pressure during the spraying operation.

2. The spray nozzle chip as claimed in claim 1, wherein the nozzle orifice has a nozzle orifice perimeter and wherein the nozzle orifice and the nozzle orifice perimeter are covered in the default non-pressurized state due to cooperation between the nozzle layer and the first layer.

3. The spray nozzle chip as claimed in claim 2, wherein the nozzle orifice perimeter is in contact with the first layer in the default non-pressurized state to thereby close the nozzle orifice.

4. The spray nozzle chip as claimed in claim 1, wherein the sealing layer is antibacterial.

5. The spray nozzle chip as claimed in claim 1, wherein the sealing layer comprises silver and/or a hydrophobic component.

6. The spray nozzle chip as claimed in claim 1, wherein the nozzle layer is mechanically more flexible than the first layer.

7. The spray nozzle chip as claimed in claim 1, wherein each of the first layer and the nozzle layer is a membrane layer.

8. The spray nozzle chip as claimed in claim 1, wherein the first layer is generally parallel with the nozzle layer.

9. The spray nozzle chip as claimed in claim 1, wherein 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-pressurized state to thereby cover the nozzle orifice and the nozzle orifice perimeter.

10. The spray nozzle chip as claimed in claim 1, wherein one of the first layer and the nozzle layer has a protruding structure which encircles the perimeter of the nozzle orifice and provides a sealing pressure to close the nozzle orifices in the default non-pressurized state.

11. The spray nozzle chip as claimed in claim 1, wherein one of the first layer a protruding structure; wherein the nozzle layer is in direct contact with and rest against the protruding structure when the nozzle layer returns to the default non-pressurized state.

12. The spray nozzle chip as claimed in claim 1, comprising a substrate supporting the first layer, which substrate is provided with a fluid supply orifice configured to supply fluid to the first layer orifice.

13. The spray nozzle chip as claimed in claim 1, wherein the cross-sectional area of the first layer orifice is smaller than the cross-sectional area of the nozzle orifice.

14. The spray nozzle chip as claimed in claim 1, wherein the first layer is a sieve layer comprising a plurality of first layer orifices configured to be in fluid communication with the nozzle orifice when the nozzle layer is deformed due to pressure during a spraying operation.

15. The spray nozzle chip as claimed in claim 1, wherein the spray nozzle chip 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.

16. The spray nozzle chip as claimed in claim 15, wherein the support layer is a thin film layer.

17. The spray nozzle chip as claimed in claim 1, wherein the first layer has a first surface which faces a second surface on the nozzle layer; wherein the first and/or the second surface is rounded or beveled in the axial direction; or ribbed or irregular.

18. The spray nozzle chip as claimed in claim 1, wherein the nozzle chip is configured to break a passing fluid jet up into micro droplets and wherein upon completion of the spraying operation the nozzle layer returns to the default non-pressurized state such that a portion of the sealing layer cooperates with the nozzle layer to close the nozzle orifice.

19. A medicament delivery device comprising a spray nozzle chip as claimed in claim 1.

20. The medicament delivery device as claim 19, wherein the medicament delivery device comprises a container holder and a medicament delivery member; wherein medicament delivery member comprises a nozzle device holder configured to hold the spray nozzle chip.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

(2) FIG. 1a schematically shows a section of a spray nozzle chip in a default non-pressurised state;

(3) FIG. 1b schematically shows the spray nozzle chip in FIG. 1a during a spraying operation;

(4) FIG. 2a schematically shows a longitudinal section of another example of a spray nozzle chip in a default non-pressurised state;

(5) FIG. 2b schematically shows the spray nozzle chip in FIG. 2a during a spraying operation;

(6) FIG. 3 schematically depicts a section of yet another example of a spray nozzle chip;

(7) FIG. 4a schematically shows longitudinal sections of another example of a spray nozzle chip in a default non-pressurised state and during a spraying operation, respectively;

(8) FIG. 4b schematically shows longitudinal sections of another example of a spray nozzle chip in a default non-pressurised state and during a spraying operation, respectively;

(9) FIG. 5a schematically shows longitudinal sections of yet another example of a spray nozzle chip in a default non-pressurised state and during a spraying operation, respectively;

(10) FIG. 5b schematically shows longitudinal sections of yet another example of a spray nozzle chip in a default non-pressurised state and during a spraying operation, respectively;

(11) FIG. 6a schematically shows a further example of spray nozzle chips with geometric surface modifications;

(12) FIG. 6b schematically shows a further example of spray nozzle chips with geometric surface modifications;

(13) FIG. 6c schematically shows a further example of spray nozzle chips with geometric surface modifications;

(14) FIG. 7a schematically shows section of the spray nozzle chip in FIGS. 2a and 2b during manufacturing thereof;

(15) FIG. 7b schematically shows a section of the spray nozzle chip in FIGS. 2a and 2b during manufacturing thereof;

(16) FIG. 7c schematically shows a section of the spray nozzle chip in FIGS. 2a and 2b during manufacturing thereof;

(17) FIG. 7d schematically shows a section of the spray nozzle chip in FIGS. 2a and 2b during manufacturing thereof;

(18) FIG. 8 shows an example of a particular manufacturing step of a spray nozzle chip; and

(19) FIG. 9 depicts an example of a container holder and a medicament delivery member of a medicament delivery device comprising a spray nozzle chip.

DETAILED DESCRIPTION

(20) 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.

(21) FIG. 1a shows an example of a spray nozzle chip. The spray nozzle chip 1 is configured to be installed in a medicament delivery device.

(22) 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.

(23) In FIG. 1a, the spray nozzle chip 1 is shown when the pressure acting on the first layer 7 is essentially zero. The nozzle layer 9 is thus in a default non-pressurised state. This is generally the case when the spray nozzle chip 1 is not being used.

(24) 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.

(25) 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.

(26) 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.

(27) 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 FIG. 1a due to the rather rough dimensioning of the support layer 11 in the drawing, the nozzle layer 9 bears against, i.e. is in direct contact with the first layer 7. In particular, the nozzle orifice perimeter 9b bears against the first layer 7. Since the first layer 7 defines a continuous surface 7b in the region which is aligned with the nozzle orifice 9a the nozzle orifice 9a and the nozzle orifice perimeter 9b are closed and covered by the first layer 7 in the default non-pressurised state of the nozzle layer 9 shown in FIG. 1a. This covering of the nozzle orifice 9 and the nozzle orifice perimeter 9a acts as a barrier against microbes when the spray nozzle chip 1 is not being used.

(28) 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.

(29) FIG. 1b shows the spray nozzle chip 1 during a spraying operation. The flow of a medicament fluid F is illustrated by a plurality of arrows. The fluid F flows through the fluid supply orifice 3a towards the first layer 7 and its plurality of first layer orifices 7a. The fluid F then flows through the first layer orifices 7a. This causes a pressure drop over the first layer 7. When the nozzle layer 9 is subjected to pressure in this situation, the nozzle layer 9 flexes away from the first layer 7. This leads to uncovering and thus opening of the nozzle orifice 9a, allowing the fluid F to flow through the nozzle orifice 9a. The nozzle layer 9 and the first layer 7 hence provide a valve functionality of the spray nozzle chip 1.

(30) 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.

(31) 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.

(32) FIG. 2a shows another example of a spray nozzle chip configured to be installed in a medicament delivery device. The spray nozzle chip 1-1 is similar in structure to the example provided in FIG. 1a. The spray nozzle chip 1-1 however further comprises a sealing layer 15. The sealing layer 15 is configured to seal, for example hermetically seal, the nozzle orifice 9a before initial use of the spray nozzle chip 1-1. The sealing layer 15 is provided, e.g. coated or deposited, on an outer surface of the nozzle layer 9. The outer surface of the nozzle layer 9 faces away from the first layer 7. The sealing layer 15 may follow the structure of the nozzle layer 9 and thus the sealing layer 15 may not entirely fill up the nozzle orifice 9a. The sealing layer 15 attaches to the continuous surface 7b of the first layer 7, which continuous surface 7b is aligned with the nozzle orifice 9a in a direction along the central axis A. According to one example, the sealing layer 15 may have an essentially uniform thickness along its extension on the nozzle layer 9.

(33) 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.

(34) 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 FIG. 2b. The fluid F will thus be atomised in the same manner as has been described with reference to FIG. 1b once the sealing layer 15 has ruptured. The rupturing of the sealing layer 15 may result in that a sealing layer portion 15a of the ruptured sealing layer 15 remains attached to the continuous surface 7b of the first layer 7. The sealing layer portion 15a forms a protruding structure on the first layer 7. The nozzle layer 9 may hence be in direct contact with and rest against the sealing layer portion 15a when the nozzle layer 9 returns to its default non-pressurised state. Hereto, the sealing layer portion 15a may act as a valve seat and may close the nozzle orifice 9a in the default non-pressurised state.

(35) FIG. 3 shows another example of a spray nozzle chip configured to be installed in a medicament delivery device. The spray nozzle chip 1-2 is similar to the example shown in FIGS. 1a and 1b. The spray nozzle chip 1-2 however has a different configuration of the nozzle layer 9. The exemplified nozzle layer 9 is curved towards the first layer 7. This curved, bent, or concave structure towards the first layer 7 may be a bimorph-structure or induced by residual stress in the layer during manufacturing. The nozzle layer 9 and the first layer 7 may for example during manufacturing be provided with different residual stress, e.g. by using different material for the two layers 7 and 9. By proper selection of the materials, this results in that the nozzle layer 9 is biased or pre-tensioned and bends towards the first layer 7, Additionally, or alternatively, another layer may be added onto the nozzle layer, which shows compressive stress and forces the nozzle layer towards the first layer. It is to be noted that the nozzle layer does not have to be curved or bent to obtain a valve functionality using built-in stress. Thus, the nozzle orifice perimeter 9b will by default be pressed towards the continuous surface 7b of the first layer 7 when the nozzle layer 9 is in the default non-pressurised state. When the spray nozzle chip 1-2 is in use, i.e. during a spraying operation, the nozzle layer 9 will flex away from the first layer 7 in a similar manner as in the previous two examples. Fluid may thus be dispensed via the spray nozzle chip 1-2. The pre-tensioned nozzle layer 9 provides a greater sealing force of the orifice perimeter 9b against the continuous surface 7b, which results in an improved seal of the nozzle orifice 9a when the nozzle layer 9 is in the non-pressurised state.

(36) In addition to the configuration shown in FIG. 3, the spray nozzle chip 1-2 could according to one variation also comprise a sealing layer, like in the example discussed with reference to FIGS. 2a and 2b.

(37) FIG. 4a shows another example of a spray nozzle chip. The spray nozzle chip 1-3 is similar to the previously described spray nozzle chip 1-2. The substrate 3-1 of the spray nozzle chip 1-3 however differs from the previously described substrate 3. The substrate 3-1 has a plurality of fluid supply orifices, namely a first fluid supply orifice 3-1a and a second fluid supply orifice 3-1b both of which extends to respective set of first layer orifices 7a. The substrate 3-1 has a separating wall 3-1c which separates the first fluid supply orifice 3-1a and the second fluid supply orifice 3-1b. The separating wall 3-1c is aligned with the nozzle orifice 9a, and supports the continuous surface 7b of the first layer 7. The continuous surface 7b is aligned with the nozzle orifice 9a. Thus, during the default non-pressurised state of the nozzle layer 9, the nozzle layer 9 rests against the continuous surface 7b and/or against a sealing layer portion of the ruptured sealing layer 15 if it remains attached to the continuous surface 7b after the sealing layer 15 has been ruptured. FIG. 4b shows the spray nozzle chip 1-3 in use, when the nozzle layer 9 flexes away from the first layer 7.

(38) FIG. 5a shows a spray nozzle chip 1-4 which is similar to the one disclosed in FIGS. 4a and 4b. The first layer 9 in this example however comprises fewer first layer orifices 7a. In the example shown in FIGS. 4a and 4b, the number of first layer orifices 7a corresponds to the number of fluid supply orifices of the substrate 1-3. FIG. 5b shows the spray nozzle chip 1-4 in use.

(39) FIGS. 6a to 6c show various examples of spray nozzle chips 1-5, 1-6, 1-7, which may or may not comprise any support layer. In case the support layer is present, the support layer can be made very thin, down to the order of Angstrom. In both cases, to ensure that the nozzle layer 9, 9-1 and the first layer 7-1, 7-2, 7-3 do not stick to each other, to allow flexing of the nozzle layer 9, 9-1 relative to the first layer 7-1, 7-2, 7-3 and thus the valve functionality, one or both of these layers have facing surfaces that have been geometrically modified. In the example in FIG. 6a, the first layer 7-1 has a surface which faces the nozzle layer 9 which has been geometrically modified. The same applies to the example in FIG. 6b. In FIG. 6a, the perimeters of the first layer orifices 7a have been rounded or bevelled in the axial direction. This reduces the surface area in contact with the opposing layer. In the example in FIG. 6b, the surface of the first layer 7-2, which faces the nozzle layer 9 has been made ribbed or irregular. In the example in FIG. 6c, the surface of the nozzle layer 9-1 facing the first layer 7 has been ribbed or made irregular. During manufacturing, the bonding between the nozzle layer and the first layer may in these cases be made by using for example fusion-bonding in selected area, i.e. laterally, so that the valve functionality is obtained. These examples may also comprise the sealing layer.

(40) An example of manufacturing a spray nozzle chip 1, 1-1, 1-2 will now be described with reference to FIGS. 7a-d. It should be noted that the spray nozzle chip 1, 1-1, 1-2 may be manufactured according to a plurality of different processes.

(41) 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.

(42) A second deposition, onto the first layer 7 to obtain the support layer 11 may then be performed.

(43) 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 FIG. 7a.

(44) Next, as shown in FIG. 7b, the support layer 11 is undercut to free the continuous surface 7b of the first layer 7, which is aligned with the nozzle orifice 9a. The undercutting may for example be made using wet or dry etching. Undercutting allows for the sealing layer deposited in the next step described herein to extend below the nozzle layer 9. An alternative to undercutting is to only remove the portion of the support layer 11 which is aligned with the nozzle orifice 9 to expose the continuous surface 7a below the nozzle orifice 9, and thus performing no undercutting.

(45) FIG. 7c shows a sealing layer deposition step. In this step, a fourth deposition onto the nozzle layer 9 is performed to obtain the hermetic sealing layer 15. The fourth deposition is performed such that the hermetic sealing layer 15 partially fills up the nozzle orifice 9a and bonds with the underlying continuous surface 7b which forms part of the first layer 7.

(46) Turning now to FIG. 7d, the substrate 3 is etched to obtain the fluid supply orifice 3a which extends from one side of the substrate 3 to an opposite side of the substrate 3. In particular, the fluid supply orifice 3a extends the entire distance to the first layer 7 and connects with the first orifices 7a.

(47) The support layer 11 is finally further undercut to free all of the first layer orifices 7a.

(48) In a manufacturing variation concerning the depositions, as shown in FIG. 8, the nozzle layer 9 and the first layer 7 may be bonded using two wafers or substrates, with an auxiliary substrate 17 being provided with the nozzle layer 9 and the substrate 3 being provided with the first layer 7 by means of transfer. The auxiliary substrate 17 and the substrate 3 may be Silicon on Insulator (SOI) wafers. The nozzle layer 9 and the first layer 7 may then be bonded whereby the transfer is performed, i.e. the nozzle layer 9 is separated from the auxiliary substrate 17. This eliminates the problem of having to etch an intermediate layer/support layer through the nozzle orifice(s).

(49) In any example herein, there may optionally be provided a silicon oxide layer between the first layer and the substrate.

(50) 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. FIG. 9 shows an example of a container holder and a medicament delivery member 19 of a medicament delivery device in a longitudinal section comprising the spray nozzle chip 1, 1-1, 1-2 attached to a nozzle device holder.

(51) 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.