DEVICE FOR PROVIDING A CONSTANT AMOUNT OF AEROSOL

Abstract

The invention relates to a device (10) for providing an aerosol from an aerosolizable material, the device comprising an aerosolization unit (300) through which pressure pulses of a carrier gas (60) are passed; a reservoir (100) comprising the aerosolizable material and which provides the aerosolizable material to the aerosolization unit (300) where the aerosolizable material is entrained by the carrier gas (60); a material providing valve (210) located between the reservoir (100) and the aerosolization unit (300) which opens in direction of the aerosolization unit (300) and which is opened and closed by a pressure difference between the reservoir (100) and the aerosolization unit (300) and which provides, in an open state, the aerosolizable material to the aerosolization unit (300).

Claims

1. A device (10) for providing an aerosol from an aerosolizable material, the device comprising: an aerosolization unit (300) through which pressure pulses of a carrier gas (60) are passed, a reservoir (100) comprising the aerosolizable material and which provides the aerosolizable material to the aerosolization unit (300) where the aerosolizable material is entrained by the carrier gas (60), a material providing valve (210) located between the reservoir (100) and the aerosolization unit (300) which opens towards the aerosolization unit (300) and which is configured to be opened and closed by a pressure difference between the reservoir (100) and the aerosolization unit (300) and which provides, in an open state, the aerosolizable material to the aerosolization unit (300).

2. The device (10) according to claim 1, wherein the material providing valve (210) is configured in such a way that it is closed when no pressure difference between the reservoir (100) and the aerosolization unit (300) exists and is open when the pressure difference between the reservoir (100) and the aerosolization unit (300) is larger than a predefined positive value

3. The device according to claim 1, wherein the material providing valve (210) is a duckbill valve.

4. The device according to claim 1, further comprising a control module (200) for controlling the material providing valve configured to control the amount of aerosolizable material provided to the aerosolization unit (300).

5. The device according to claim 4, wherein the control module (200) comprises a force applying element (250) providing a mechanical force applied to the material providing valve (210), the force applying element (250) via the applied mechanical force influencing the amount of aerosolizable material provided to the aerosolization unit (300) by controlling an opening degree of the material providing valve.

6. The device according to claim 3, wherein the force applying element (250) applies the mechanical force to a side surface (211) of the duckbill valve (210).

7. The device according to claim 5, wherein the control module (200) furthermore comprises a force translating unit (230) which translates a generated mechanical force to the force applying element which applies the mechanical force to the material providing valve.

8. The device according to claim 5, wherein the control module (200) furthermore comprises an actuating element (260) configured to generate and control the mechanical force applied to the material providing valve (210).

9. The device according to claim 7, wherein the actuating element (260) applies the generated mechanical force to the force translating unit (230) which transmits the generated mechanical force to the force applying element (250).

10. The device according to claim 6, wherein the force applying element is connected to the duckbill valve in such a way that it is configured to apply a pulling force to the duckbill valve to actively open the duckbill valve, and to apply a compression force in a direction opposite to the pulling force by which a preload is applied to the duckbill valve which controls the opening degree of the duckbill valve when the duckbill valve is opened by a pressure pulse.

11. The device according to claim 6, wherein the force applying element is fixedly connected to the duckbill valve and the actuating element is fixedly connected to the force applying element so as to apply a pulling force to the duckbill valve to actively open the duckbill valve, and to apply a compression force in a direction opposite to the pulling force by which a preload is applied to the duckbill valve which controls the opening degree of the duckbill valve when the duckbill valve is opened by a pressure pulse.

12. The device according to claim 1, wherein the reservoir (100) comprises an air inlet valve (120) which opens in the direction of the reservoir (100) and which is configured to keep an ambient air pressure in the reservoir (100).

13. The device according to claim 1, wherein the reservoir (100) comprises a pressure compensation valve (130) which connects the reservoir (100) with the aerosolization unit (300) and which is opened when the material providing valve remains stuck in an open state and which opens in direction of the aerosolization unit when a pressure in the reservoir (100) is higher than a pressure in the aerosolization unit.

14. The device according to claim 13, wherein the pressure compensation valve (130) is configured to open at a pressure difference that is 10 to 20 times lower than the pressure difference needed to open the material providing valve (210).

15. The device according to claim 1, further comprising a sensing element (500) configured to determine the amount of aerosolizable material in the generated aerosol.

16. The device according to claim 5, wherein the sensing element (500) is configured to control the force applying element (250) in dependence of a deviation of the determined amount of aerosolizable material in the generated aerosol from a predefined amount of aerosolizable material in the generated aerosol.

17. A control system comprising: a duckbill valve configured to supply a fluid in a flow direction and configured to prevent flow of the fluid in a direction opposite to the flow direction, a control module (200) configured to control the amount of fluid supplied by the duckbill valve (210) in the flow direction in an open state of the duckbill valve, wherein the control module (200) comprises a force applying element (250) configured to apply a mechanical force onto the duckbill valve (210), the force applying element (250), with the applied mechanical force, being configured to influence the amount of fluid provided by the duckbill valve in the open state.

18. The control system according to claim 17, wherein the force applying element (250) applies the mechanical force onto a side surface (211) of the duckbill valve, to control an opening degree of the duckbill valve.

19. The control system according to claim 17, wherein the control module (200) furthermore comprises a force translating unit (230) which translates a generated mechanical force to the force applying element which applies the mechanical force to the duckbill valve (210).

20. The control system according to claim 17, wherein the control module (200) furthermore comprises an actuating element (260) configured to generate and control the mechanical force applied to the duckbill valve (210).

21. The control system according to claim 19, wherein the actuating element (260) applies the generated mechanical force to the force translating unit (230) which transmits the generated mechanical force to the force applying element (250).

22. The control system according to claim 17, wherein the force applying element is connected to the duckbill valve in such a way that it is configured to apply a pulling force onto the duckbill valve to actively open the duckbill valve, and to apply a compression force in a direction opposite to the pulling force by which a preload is applied to the duckbill valve which controls the opening degree of the duckbill valve when the duckbill valve is opened by the pressure pulse.

23. The control system according to claim 17, wherein the force applying element is fixedly connected to the duckbill valve and the actuating element is fixedly connected to the force applying element so as to apply a pulling force to the duckbill valve to actively open the duckbill valve, and to apply a compression force in a direction opposite to the pulling force by which a preload is applied to the duckbill valve which controls the opening degree of the duckbill valve when the duckbill valve is opened by a pressure pulse.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG. 1 shows a schematic side elevation view of a device for providing an aerosol including a material providing valve,

[0024] FIG. 2 shows an exploded view of the different components of the device of FIG. 1,

[0025] FIG. 3 shows an exploded view of a control module with which the amount of aerosolizable material provided by the material providing device can be controlled,

[0026] FIG. 4 is a sectional view of the control module of FIG. 3 in an assembled state,

[0027] FIG. 5 is a schematic view of the pneumatics in the device of FIG. 1,

[0028] FIG. 6 is a schematic view of a sensing element configured to determine the amount of aerosolizable material in the generated aerosol,

[0029] FIG. 7 shows a schematic view of how the sensing element is incorporated into a device for aerosolization, and

[0030] FIG. 8 is a schematic view of how a feedback control circuit is generated with the sensing element to control the amount of aerosolizable material in the generated aerosol.

DETAILED DESCRIPTION

[0031] In connection with FIGS. 1 and 2, the device for providing an aerosol will be described in further detail, wherein in FIGS. 3 and 4 a control mechanism configured to control the amount of aerosolizable material provided to an aerosolization channel of the device will be explained in more detail.

[0032] The device for providing an aerosol comprises a reservoir 100 for the aerosolizable material, i.e. powdery material to be aerosolized. The reservoir 100 comprises an outer wall 101 and an inner cylindrical wall 102. The reservoir furthermore comprises a funnel-like tapered wall 103. Some or all of the walls 102, 103 can be self-exciting membranes made of e.g. medical grade silicone preferably having a wall thickness of about 0.5 mm. Where a wall is formed by a self-exciting membrane, there are spaces formed between the outer wall 101 and the cylindrical and conical walls 102 and 103. Regarding any details of the use of self-exciting membranes as inner walls of an aerosolization device, reference is made to WO 2010/122103 A1. At the bottom of the reservoir, an aperture 105 is located above an aerosolization unit 300 which comprises a capillary tube 350, a chamber, an aerosolization channel 360 and a dispersing nozzle 370. The aerosolization unit 300 is configured such that the capillary tube 350 is, via the chamber and the aerosolization channel 360, in fluid flow connection with the dispersing nozzle 370. In addition, the aerosolization unit 300 is configured such that, when the unit is in its operating position under the reservoir within the device for providing an aerosol and provided the material providing valve 210 is in an open state, the capillary tube 350 is, via the chamber and the aperture 105, in fluid flow connection with the reservoir 100. On top of the reservoir 100, a lid 106 is provided that tightly closes the reservoir. An air inlet valve 120 is provided which opens in the direction of the reservoir and which is configured to maintain an ambient air pressure in the reservoir. When aerosolizable material is provided through the aperture 105 to the aerosolization unit 300, the air inlet valve 120 provides the amount of air that is needed to keep the pressure inside the reservoir substantially unchanged.

[0033] Furthermore, a pressure compensation valve 130 is provided which connects the reservoir with the auxiliary air channel 30. The functioning of this pressure compensation valve will be explained in further detail below with reference to FIG. 5, where the pneumatic situation of the whole device is explained in more detail.

[0034] Referring to the embodiment of FIGS. 1 and 2, compressed carrier gas is fed in form of pulses to a capillary tube 350, the end of which protrudes into a chamber. On the opposite side the chamber opens out into an aerosolization channel 360, which in turn opens out into a dispersing nozzle 370 whose cross-section increases continuously in a direction extending away from the capillary tube 350. In operation, pressure pulses of the carrier gas enter the aerosolization channel 360 of the device through the capillary tube 350 and, due to the pressure difference created according to Venturi's principle between the gas exciting the capillary and the reservoir, aerosolizable material is sucked from the reservoir into the aerosolization channel 360, dispersed and entrained in the carrier gas. At the same time, this pressure pulse also acts on tapered membrane wall 103 at the bottom of reservoir 100 and on the membrane walls 401 and 402 of a spacer 400, causing them to bulge and oscillate according to the frequency of the pressure pulses. Thus, aerosolizable material adhering to the walls (if any) is loosened and free to be entrained by the carrier gas stream again. The dispersing nozzle 370 opens into the spacer which comprises a distal portion 410 with conical inner wall 411 and a proximal portion 420 with the conical inner wall 402 tapered proximally, the distal portion 410 and the proximal portion 420 being connected by a central portion 430 with cylindrical inner wall 401. Like the walls of the reservoir, the walls of the spacer can be self-exciting membranes made of, e.g., silicone. Further details of the device shown in FIGS. 1 and 2 can also be taken from WO 2010/122103 A1.

[0035] However, other than the device as disclosed in WO 2010/122103 A1, the device according to the invention in addition contains a material providing valve 210 which is shown in FIG. 3 and which is incorporated in a control module 200. The material providing valve 210 opens towards the aerosolization channel 360 and is mainly activated by a pressure difference between the pressure in the reservoir and the pressure in the aerosolization channel 360. When in accordance with Venturi's principle a pressure pulse is generated in the aerosolization channel 360, the pressure in the aerosolization channel will be lower than the pressure in the reservoir and the material providing valve 210 will be opened by this pressure difference.

[0036] In the embodiment of FIG. 3 the material providing valve is a duckbill valve (sometimes called a duckbill check valve). This duckbill valve allows a fluid to flow in one direction through a conduit, while closing and preventing back or reverse flow when the direction of the pressure gradient across the valve is reversed. The valve 210 provides an amount of aerosolizable material to the aerosolization channel 360. The amount of aerosolizable material provided by the duckbill valve can be controlled. To this end the control module 200 is provided which will be explained below with reference to FIGS. 3 and 4. The control module comprises a force applying element 250. As shown in FIG. 4, this force applying element can apply a mechanical force to the broad lateral side of the duckbill valve, having the effect of a preload. The preload applied to the duckbill valve can be controlled via an actuating element 260. The actuating element is connected to the force applying element 250, either directly or via a force translating unit 230. The force translating unit 230, which may be a component made of an elastomer, can be placed between the actuating element 260 and the force applying element 250. The force applied to the lateral side surface of the duckbill valve controls the opening degree of the duckbill valve when a pressure pulse in the aerosolization channel 360 occurs. The more preload the force applying element applies to the side surface of the duckbill valve, the smaller the opening degree of the duckbill valve will be. The control module 200 is provided in a housing 240 with a cylindrical side surface 270. The duckbill valve 210 is located on a seat 220 which comprises an opening 221 through which the aerosolizable material from the reservoir will be fed to the duckbill valve 210. A seal ring 280 will help to provide an airtight connection of the control module to the aerosolization channel 360. If desired, a unit formed of valve 210, seat 220, housing 240 and seal ring 280 can be manufactured in one piece, which optionally can also comprise force applying element 250.

[0037] The force applying element can not only apply a preload and thus a compression force onto the side surface 211 of the duckbill valve, but also a pulling force can be generated. To this end, the force applying element 250 can be fixedly connected (i.e., attached) to the duckbill valve 210. The actuating element which is also fixedly connected to the force applying element can now pull the valve's side surface 211 in such a way that the control module actively opens the duckbill valve. In normal use, the duckbill valve will be opened by the pressure difference generated by the pressure pulses. However, when aerosolizable material is stuck in the duckbill valve and when the opening of the duckbill valve is clogged with aerosolizable material, it may be necessary to actively open the valve to remove any particle agglomerations which are stuck in the duckbill valve and which impede the proper functioning of the valve.

[0038] In one embodiment, the force translating element 230 and the force applying element 250 may be made as a one-piece element, so that the actuating element 260 only needs to be fixedly connected to this one-piece element in order to be able to generate a pulling force which opens the valve.

[0039] The amount of aerosolizable material provided by the valve 210 can also be controlled by a proper selection of the material of the duckbill valve and by the selection of the duckbill's geometry and width. The actuating element may be a screw provided in a threaded opening in the control module. This screw may be actuated by a user or by a motor such as a linear motor.

[0040] In connection with FIGS. 6-8, an embodiment is disclosed in which the actuating element will be controlled by a sensing element 500 which is configured to determine the amount of aerosolized material in the generated aerosol. The determination of the amount of aerosolized material in the generated aerosol can be accomplished, e.g., by determining a scattering of a light by the aerosol. The aerosol exiting the device disclosed in connection with FIGS. 1 and 2 will be fed to the sensing element 500. The sensing element can comprise a light source and a detector for the scattered light. The sensing element may be a sensing element as described in DE 4 105 190 A1. The sensing element provided in a housing 510 has a light source 530 as indicated by the arrow in FIG. 6 and the light is fed through a transparent window 520. The particle concentration in the aerosol might be further determined by reduction of the light transmitted from light source 530 through the generated aerosol. It should be understood that any adherence of aerosolized particles to window 520 should be avoided. This might be achieved by using an appropriate form and material of the inner surface of the transparent window 520.

[0041] In the embodiment shown in FIG. 7, a connecting element 700 is provided through which the aerosol in the direction of the arrow enters the sensing element 500 and leaves the sensing element via connector 50 to which a tube can be connected further guiding the aerosol. The sensing element will determine the particle concentration in the aerosol. If the particle concentration is within a predefined range or if the particle concentration corresponds to a predefined value, no action is taken. If the determined particle concentration is too low, the sensing element may transmit this information to the control module, e.g. to a linear motor controlling the control element, and the linear motor may then control the actuating element 260 in such a way that the preload applied to the side surface 211 of the duckbill valve 210 is lowered. If the particle concentration in the aerosol is too high, the linear motor may be controlled in such a way that the actuating element transmits a higher force to the force applying element so that the preload onto the valve's side surface is increased. This increased preload will reduce the opening degree of the material providing valve when a pressure pulse arrives in the aerosolization unit 300, thus reducing the amount of aerosolizable material sucked into the aerosolization channel 360 by the pressure pulse.

[0042] In the embodiment of FIG. 8, the device for aerosolization is connected to a humidifier 600. As described in WO 2012/025496 A1, the generated aerosol may be humidified before it is administered to a patient. The humidification step helps to prevent the particles in the aerosol from agglomerating. In the embodiment of FIG. 8, the sensing element is provided directly at the exit 610 of the humidifier 600. However, it should be understood that the sensing element may also be provided directly at the exit 11 of the device for aerosolization as shown in FIG. 6, or at any other position of the aerosol's flow path.

[0043] In FIG. 5, a pneumatic plan of the device for aerosolization is shown. A source 20 of pressure gas transmits pressure pulses to the aerosolization unit 300 after having passed a filter 60. The reservoir 100 is schematically shown which is connected via an air inlet valve 120 to the ambient air, wherein a filter 70 may be provided before the ambient air enters the reservoir 100. As can be seen from FIG. 5, the air inlet valve opens in the direction of the reservoir. The material providing valve 210 is schematically shown between the reservoir 100 and the aerosolization unit 300. Furthermore, the actuating element 260 is schematically shown via which the amount of fluid provided by the valve can be controlled. The generated aerosol is fed from the aerosolization channel to spacer 400 which contains the inner walls 401.

[0044] Between the spacer and the aerosolization unit 300 an auxiliary connecting line 30 supplies unpulsed air to the spacer to thereby flush the spacer of residues of aerosolizable material. A filter 75 is provided to block contamination by undesired particles. A valve 35 is provided between the spacer and the supplied unpulsed air to prevent pressure pulses from propagating in the direction of the supplied air and to assure that the supplied air can be supplied to the device. As shown in FIG. 5, a pressure compensation valve 130 is provided which is connected between the reservoir 100 and the line connecting the aerosolization unit 300 to the spacer 400. This pressure compensation valve only opens in the direction of the spacer or aerosolization unit and can help to remove an undesired higher pressure from the reservoir. When the material providing valve is clogged with aerosolizable material, e.g. when the material agglomerates in the duckbill so that the duckbill cannot be closed anymore, the air supply of the unpulsed air 30 may generate a high pressure in the reservoir. For example, the unpulsed air may be supplied at a rate of 0.7 liter/min. This higher pressure in the reservoir 100 can be avoided with the use of pressure compensation valve 130. This pressure compensation valve may open at a pressure difference between the reservoir and the spacer or aerosolization unit of, e.g., 5 mbar. The pressure compensation valve opens when the pressure in the reservoir is higher than in the spacer or aerosolization unit and feeds the pressure back into the aerosolization channel via a return channel 150 shown in FIGS. 1 and 2. The pressure compensation valve 130 opens at a pressure difference which is much lower than the pressure difference needed to open the material providing valve if it worked properly. By way of example, the pressure difference needed to open the properly functioning material providing valve may be around 100 mbar. The pressure compensation valve transmits the generated pressure in the reservoir back into the system. This pressure compensation valve helps to make sure that the amount of additional aerosolizable material that is fed to the aerosolization unit is minimized.