HIGH PRESSURE INHALATION DEVICE

Abstract

The invention relates to the field of inhalation devices for medically active liquids. In particular, the invention relates to an inhalation device providing a particularly high pressure for nebulization. The inhalation device comprises a housing (1), a reservoir (2), a pumping unit connected (3) to a means for the delivery of mechanical energy (4) to said pumping unit (3), and a nozzle (5). The pumping unit (3) comprises a hollow cylindrical part (3A) and a piston (3B), the cylindrical part (3A) having an interior space (3C) with a defined first cross section (A1) configured to receive an upstream end portion (3B′) of said piston (3B), wherein said cylindrical part (3A) and said piston (3B) are linearly moveable relative to one another such as to form a pumping chamber having a variable volume. According to the invention, the means for the delivery of mechanical energy (4) is a pressurised gas, wherein the device comprises a pressure chamber (6) having an internal volume for holding said pressurized gas, a wall of said pressure chamber (6) being provided by a plunger (7) which is configured to perform a reciprocating linear movement such as to change the internal volume of the pressure chamber (6), wherein the plunger (7) is mechanically coupled to the piston (3B) or to the cylindrical part (3A), and wherein the plunger (7) exhibits a cross section (A2) which is larger than the cross section (A1) of the pumping chamber. Further, a method for generation of an aerosol of a medically active liquid by means of said inhalation device is disclosed.

Claims

1. Inhalation device for generation of an aerosol of a medically active liquid, comprising: a housing, inside this housing a reservoir for storing said medically active liquid, downstream this reservoir a pumping unit for generation of a pressure connected to a means for the delivery of mechanical energy to said pumping unit, and downstream said pumping unit a nozzle; wherein the pumping unit comprises a hollow cylindrical part and a piston, the cylindrical part having an interior space with a defined first cross section configured to receive an upstream end portion of said piston, wherein said cylindrical part and said piston are linearly moveable relative to one another such as to form a pumping chamber having a variable volume, wherein the means for the delivery of mechanical energy is a pressurised gas, wherein the inhalation device comprises a pressure chamber having an internal volume for holding said pressurized gas, a wall of said pressure chamber being provided by a plunger which is configured to perform a reciprocating linear movement such as to change the internal volume of the pressure chamber, wherein the plunger is mechanically coupled to the piston or to the cylindrical part of the pumping unit, and wherein the plunger exhibits a cross section which is larger than the cross section of the pumping chamber.

2. Inhalation device according to claim 1, wherein the ratio of the cross section of the plunger to the cross section of the pumping chamber is greater than 2.

3. Inhalation device according to claim 1, wherein the ratio of the cross section of the plunger to the cross section of the pumping chamber is greater than 10.

4. Inhalation device according to claim 1, wherein the pressurised gas is provided by a container filled with pressurized and/or liquefied gas, or chamber which is manually pressurizeable, and which can temporarily hold and controllably release said pressurised gas.

5. Inhalation device according to claim 1, wherein the piston is hollow.

6. Inhalation device according to claim 1, wherein either, the piston is immobile and firmly attached to the housing or to the nozzle, and the hollow cylindrical part is moveable relative to the housing or to the nozzle, or the hollow cylindrical part is immobile and firmly attached to the housing or to the nozzle, and the piston is moveable relative to the housing or to the nozzle.

7. Inhalation device according to claim 1, wherein a check valve is arranged upstream the pumping chamber in order to block backflow of liquid in direction of the reservoir.

8. Inhalation device according to claim 1, wherein additionally, a mechanical lever mechanism is provided for further increasing the amplification effect of the aforesaid ratio.

9. Inhalation device according to claim 1, wherein a means for the temporary storage of mechanical energy is provided which is loadable by a propulsive movement of the plunger, and which is configured, by unloading its stored energy, to effect a retropulsive movement of the plunger.

10. Inhalation device according to claim 9, wherein said means for the temporary storage of mechanical energy is an elastic spring, a gas spring, or a magnetic spring.

11. Inhalation device according to claim 1, wherein the nozzle is of the impingement type.

12. Inhalation device according to claim 1, wherein the volume of the pumping chamber amounts to at least 30 μl, or at least 50 μl, or from about 100 to 250 μl.

13. Inhalation device according to claim 1, wherein the pumping unit is configured to provide a pressure of at least 100 bar inside the pumping chamber.

14. Inhalation device according to claim 1, wherein (i) the plunger and (ii) the piston and/or the cylindrical part are moveable in parallel directions.

15. Method for generation of an aerosol of a liquid by means of an inhalation device as defined in claim 1, wherein the method comprises the following steps: in a filling phase, providing a negative gauge pressure inside the pumping chamber by increasing its volume, and thereby filling the pumping chamber with liquid from the reservoir due to said negative gauge pressure; in an emission phase, providing a positive gauge pressure inside the pressure chamber having said second cross section, and thereby effecting a movement of the plunger; transferring said movement mechanically to the piston or to the cylindrical part, such that the volume of the pumping chamber is reduced, and a positive pressure is generated inside its interior space; and thus emitting the medically active liquid from the pumping chamber through the nozzle; wherein the pressure of the pressure chamber is amplified.

16. Method according to claim 15, wherein the pressure within the pressure chamber is provided by opening a valve to a container with a pressurized gas, or by manually pressurizing said pressure chamber.

17. Method according to claim 15, wherein, subsequent to the emission of liquid from the pumping chamber due to the reduction of its volume, a means for temporary storage of mechanical energy which has been loaded during the emission phase releases the stored energy, thus increasing the pumping chamber's interior space again, resulting in a generation of a negative pressure therein, thus refilling the pumping chamber with medically active liquid from the reservoir.

18. Method according to claim 15, wherein, at the beginning of the refilling phase, the pressure chamber's content is discharged to the atmosphere.

19. Method of inhalatively administering a medically active liquid to an animal or human, the method comprising inhalatively administering the medically active liquid in aerosolized form with the inhalation device of claim 1 to the animal or human.

20. Method for the treatment, stabilization or prevention of a pulmonary disease or condition by inhalative administration of a medically active liquid, wherein the medically active liquid is generated and administered by an inhalation device according to claim 1.

Description

DESCRIPTION OF FIGURES

[0098] In the following, the invention is described with the aid of accompanying figures. Herein,

[0099] FIG. 1 shows a schematic drawing of some components of one embodiment of an inhalation device;

[0100] FIG. 2 shows the device of FIG. 1 at the end of the filling phase;

[0101] FIG. 3 shows the device of FIG. 1 during the emission phase;

[0102] FIG. 4 shows the device of FIG. 1 during the refilling phase.

[0103] All drawings are not to scale and contain only a selection of components, and are presented only in the level of detail which is sufficient to explain the invention. It is clear that for a functioning sample, additional components are necessary which, however, are known to the artisan and omitted here for the sake of conciseness.

[0104] In FIG. 1, a schematic drawing of some components of one embodiment of an inhalation device is shown.

[0105] Depicted are components of an inhalation device which serves for generation of an aerosol. Inside a housing 1, a reservoir 2 is arranged for storing a liquid F. The depicted reservoir 2 contains a collapsible bag which in turn contains liquid F (liquid not depicted). Downstream reservoir 2, a pumping unit 3 is arranged. The pumping unit 3 is connected to a means for the delivery of mechanical energy 4 which feeds said energy to the pumping unit 3.

[0106] Downstream of said pumping unit 3, a nozzle 5 is arranged. In the depicted example, the nozzle 5 is of the impingement type.

[0107] As can be seen, the pumping unit 3 comprises a hollow cylindrical part 3A and a (in this case) hollow piston 3B. Hollow cylindrical part 3A is immobile and firmly attached to housing 1, and piston 3B is moveable relative to housing 1. In the depicted embodiment, plunger 7 and piston 3B are moveable in parallel, and in fact along collinear, directions.

[0108] The cylindrical part 3A has an interior space 3C with a defined first cross section A1. The cross section A1 can have any shape, but is preferably circular. The interior space 3C is configured to receive an upstream end portion 3B′ of said piston 3B. In case that the interior space 3C is wider, only that portion of the space 3C is taken in account which in fact serves for receiving piston 3B. Cylindrical part 3A and piston 3B are linearly moveable relative to one another such as to form a pumping chamber. Due to the possibility of said linear movement, the pumping chamber has a variable volume.

[0109] According to the invention, the means for the delivery of mechanical energy 4 is a pressurised gas, as described above. The inhalation device comprises a pressure chamber 6 having an internal volume for holding said pressurized gas. A wall of said pressure chamber 6 is provided by a plunger 7. Said plunger 7 is configured to perform a reciprocating linear movement (up- and downwards in the figure). The internal volume of the pressure chamber 6 is related to the position of the plunger, which is in turn dependent on the pressure inside the pressure chamber. An increase of pressure results in a propulsive movement (here, upwards), and a decrease of pressure in a retropulsive movement (here, downwards).

[0110] Plunger 7 is mechanically coupled to piston 3B; in a non-depicted embodiment, it can instead or additionally be coupled to cylindrical part 3A. As can be seen, plunger 7 exhibits a cross section A2 which is larger than cross section A1 of the pumping chamber. As a result, an amplification of pressure is achieved, i.e. the pressure in the pumping chamber is higher than in the pressure chamber 6 by an amplification factor or ratio, which is determined by the ratio of cross section A2 to A1.

[0111] In the depicted embodiment, the pressurised gas is provided by a container 8 comprising liquefied gas. Part of the gas is present in gaseous form (above level of liquid part, drawn in black). A valve 9 separates container 8 from pressure chamber 6.

[0112] A further valve 10 is arranged in a discharge duct of pressure chamber 6. A check valve 11 is arranged upstream the pumping chamber in order to block possible backflow of liquid in direction of the reservoir 2.

[0113] A means for the temporary storage of mechanical energy 12, in this embodiment realized by an elastic spring, is provided which is loadable by a propulsive (here, upward) movement of plunger 7. Means 12 is arranged and configured to effect, by unloading its stored energy, a retropulsive (here, downward) movement of the plunger 7 which will be shown below.

[0114] In this and the following figures, like reference numerals are used for like parts. In the following figures, some of the references are omitted for the sake of clarity. Also, further on, housing 1 is not shown.

[0115] FIG. 2 shows the situation at the end of the filling phase, with pumping chamber and pressure chamber volumes reset. Interior space 3C of pumping chamber is at a maximum, since piston 3B is at its maximally retracted position with respect to cylindrical part 3A. Plunger 7 is at its lowermost position, so that the volume of pressure chamber 6 is very small, or almost zero. The means for the temporary storage of mechanical energy 12 is relaxed and ready to be loaded with mechanical energy.

[0116] In FIG. 3, the emission phase is shown. Valve 9 is now open, such that pressurised gas can flow from container 8 into pressure chamber 6. Plunger 7 moves in direction of arrow 13 (here, upwards), transferring the force acting on the same to piston 3B. Liquid contained in the pumping chamber is therefore emitted through nozzle 5 under high pressure. Arrows 14 indicate two impinging liquid beams that result in the desired nebulization. Means 12 is being compressed, thus temporarily storing mechanical energy.

[0117] FIG. 4 shows the situation in the refilling phase. Now, valve 10 is open, such that the pressurized gas can be discharged from pressure chamber 6. No fresh gas can flow into said chamber 6, since valve 9 is now closed. A negative gauge pressure forms inside the pumping chamber which results in refilling the same from reservoir 2. The flow direction is indicated by arrow 15.

[0118] The retropulsive movement of the plunger, indicated by arrow 13, is driven by the means for the temporary storage of mechanical energy 12 which now releases its energy to the pumping unit 3, and more precisely, to plunger 7 which is connected with piston 3B. Due to check valve 11, a backflow of liquid from the outside into hollow piston 3B is prevented.

[0119] The movement of plunger 7 will come to an end when being in the reset position which is depicted in FIG. 2. The cycle is then complete and another cycle can start from the beginning.

LIST OF REFERENCE NUMBERS

[0120] 1 housing [0121] 2 reservoir [0122] 3 pumping unit [0123] 3A hollow cylindrical part [0124] 3B piston [0125] 3C interior space [0126] 4 means for the delivery of mechanical energy [0127] 5 nozzle [0128] 6 pressure chamber [0129] 7 plunger [0130] 8 container [0131] 9, 10 valve [0132] 11 check valve [0133] 12 means for the temporary storage of mechanical energy [0134] 13, 14, 15 arrow [0135] A1 first cross section [0136] A2 second cross section [0137] F liquid

[0138] The following list of numbered items are embodiments comprised by the present invention: [0139] 1. Inhalation device for generation of an aerosol of a medically active liquid, comprising: [0140] a housing (1), inside this housing (1) a reservoir (2) for storing said medically active liquid, downstream this reservoir (2) a pumping unit (3) for generation of a pressure connected to a means for the delivery of mechanical energy (4) to said pumping unit (3), and downstream said pumping unit (3) a nozzle (5); [0141] wherein the pumping unit (3) comprises a hollow cylindrical part (3A) and a piston (3B), the cylindrical part (3A) having an interior space (3C) with a defined first cross section (A1) configured to receive an upstream end portion (3B′) of said piston (3B), wherein said cylindrical part (3A) and said piston (3B) are linearly moveable relative to one another such as to form a pumping chamber having a variable volume, [0142] characterized in that [0143] the means for the delivery of mechanical energy (4) is a pressurised gas, wherein the inhalation device comprises a pressure chamber (6) having an internal volume for holding said pressurized gas, a wall of said pressure chamber (6) being provided by a plunger (7) which is configured to perform a reciprocating linear movement such as to change the internal volume of the pressure chamber (6), wherein the plunger (7) is mechanically coupled to the piston (3B) or to the cylindrical part (3A), and wherein the plunger (7) exhibits a cross section (A2) which is larger than the cross section (A1) of the pumping chamber. [0144] 2. Inhalation device according to item 1, wherein the ratio is greater than 10. [0145] 3. Inhalation device according to item 1 or 2, wherein the pressurised gas is provided by [0146] a container (8) filled with pressurized and/or liquefied gas, or [0147] a chamber which is manually pressurizeable, and which can temporarily hold and controllably release said pressurised gas. [0148] 4. Inhalation device according to any of items 1 to 3, wherein the piston (3B) is hollow. [0149] 5. Inhalation device according to any of the preceding items, wherein either, [0150] the piston (3B) is immobile and firmly attached to the housing (1) or to the nozzle (5), and the hollow cylindrical part (3A) is moveable relative to the housing (1) or to the nozzle (5), or [0151] the hollow cylindrical part (3A) is immobile and firmly attached to the housing (1) or to the nozzle (5), and the piston (3B) is moveable relative to the housing (1) or to the nozzle (5). [0152] 6. Inhalation device according to any of the preceding items, wherein a check valve (11) is arranged upstream the pumping chamber in order to block backflow of liquid in direction of the reservoir (2). [0153] 7. Inhalation device according to any of the preceding items, wherein additionally, a mechanical lever mechanism is provided for further increasing the aforesaid ratio. [0154] 8. Inhalation device according to any of the preceding items, wherein a means for the temporary storage of mechanical energy (12) is provided which is loadable by a propulsive movement of the plunger (7), and which is configured, by unloading its stored energy, to effect a retropulsive movement of the plunger (7). [0155] 9. Inhalation device according to item 8, wherein said means for the temporary storage of mechanical energy (12) is an elastic spring, a gas spring, or a magnetic spring. [0156] 10. Inhalation device according to any of the preceding items, wherein the nozzle (5) is of the impingement type, and/or wherein the volume of the pumping chamber amounts to at least 30 μl, or at least 50 μl, or from about 100 to 250 μl, respectively, and wherein the pumping unit (3) is configured to provide a pressure of at least 100 bar inside the pumping chamber. [0157] 11. Inhalation device according to any of the preceding items, wherein (i) the plunger (7) and (ii) the piston (3B) and/or the cylindrical part (3A) are moveable in parallel directions. [0158] 12. Method for generation of an aerosol of a liquid by means of an inhalation device as defined in item 1, wherein the method comprises the following steps: [0159] in a filling phase, providing a negative gauge pressure inside the pumping chamber by increasing its volume, and thereby [0160] filling the pumping chamber with liquid from the reservoir (2) due to said negative gauge pressure; [0161] in an emission phase, providing a positive gauge pressure inside the pressure chamber (6) having said second cross section (A2), and thereby [0162] effecting a movement of the plunger (7); [0163] transferring said movement mechanically to the piston (3B) or to the cylindrical part (3A), such that the volume of the pumping chamber is reduced, and a positive pressure is generated inside its interior space; and thus [0164] emitting the medically active liquid from the pumping chamber through the nozzle (5); [0165] wherein the pressure of the pressure chamber (6) is amplified. [0166] 13. Method according to item 11, wherein the pressure within the pressure chamber (6) is provided by opening a valve (9) to a container (8) with a pressurized gas, or by manually pressurizing said pressure chamber (6). [0167] 14. Method according to item 12 or 13, wherein, subsequent to the emission of liquid from the pumping chamber due to the reduction of its volume, a means for temporary storage of mechanical energy (12) which has been loaded during the emission phase releases the stored energy, thus increasing the pumping chamber's interior space again, resulting in a generation of a negative pressure therein, thus refilling the pumping chamber with medically active liquid from the reservoir (2). [0168] 15. Method according to any of items 12 to 14, wherein, at the beginning of the refilling phase, the pressure chamber's (6) content is discharged to the atmosphere.