Powder inhaler and powder inhalation set

Abstract

The invention relates to a powder inhaler and to a powder inhaler set that contains the powder inhaler. The powder inhaler comprises two half-shells (3, 4), which can be or are articulated to each other and which enclose an air inlet region, a powder deposition region and powder release region, and an outlet region in a joined arrangement, through which regions a fluid path extends. At least one of the half shells (3, 4) has at least one air inlet opening (8) in the air inlet region, and at least one air-swirling structure (5) is present in the air inlet region, which air-swirling structure defines the fluid path between the at least one air inlet opening (8) and the powder deposition and release region. Furthermore, one of the half-shells (3, 4) has at least one powder-accommodating recess (9) in the powder deposition region and powder release region, while the outlet region has at least one deagglomeration structure (17, 17) and an outlet for aerosol, which outlet is formed by the half-shells (3, 4).

Claims

1. A powder inhaler (1), comprising: two flat, elongate half shells (3, 4) connectable or connected to each other by an articulated connection and, in a joined arrangement of the half shells, enclosing an air inlet area, a powder deposition and release area, and an outlet area through which a fluid path is extending, wherein the half shells (3, 4) each are rimmed by sidewalls (32, 42) and a wall section (31, 41) opposite the outlet area; wherein, in the air inlet area, at least one of the half shells (3, 4) comprises at least one air inlet opening (8), which is arranged on the wall section (31, 41), and wherein at least one air supply channel delimited by guide webs (6) extends from the at least one air inlet opening (8) to the powder deposition and release area, wherein the at least one air supply channel has a cross-section that is tapering in a direction toward the powder deposition and release area, and wherein the at least one air supply channel defines the fluid path between the at least one air inlet opening (8) and the powder deposition and release area; wherein at least one air swirling structure (5) is disposed in the at least one air supply channel; wherein, in the powder deposition and release area, one of the half shells (3, 4) comprises at least one powder receiving depression (9) for receiving an active ingredient depression (101) of a blister element (100), wherein guide walls (7) are provided that, in the joined arrangement, frame the at least one powder receiving depression (9) along the fluid path on two sides and extend away from outermost guide webs (6) extending to the at least one powder depression (9); wherein a cross-section of the fluid path between the powder deposition and release area and the outlet area widens downstream of a passage through the powder receiving depression (9) delimited by the guide walls (7); wherein the outlet area has a tapering outlet end and an outlet for aerosol is formed by the half shells, wherein the outlet area comprises one or more de-agglomeration structures (17, 17); wherein, for opening an active ingredient depression (101) of a blister element (100) inserted into the powder inhaler (1), a pricker is provided that is elastically supported in the powder inhaler relative to the at least one powder receiving depression (9) and/or the sidewalls (32, 42) of the half shells (3, 4) delimit between them an opening at the level of the at least one powder receiving depression (9) in the joined arrangement of the half shells (3, 4), wherein, when a blister element (100) is inserted into the powder inhaler, a cover plate that closes off an active ingredient depression (101) of the blister element (100) is projecting outwardly from the opening.

2. The powder inhaler (1) according to claim 1, wherein the half shells (3, 4) comprise a substantially rectangular, trapezoidal, drop-shaped or oval base rimmed by the sidewalls (32, 42) and the wall section (31, 41), and wherein the guide webs (6), provided on at least one of the half shells (3, 4) and extending from the wall section (31, 41) and/or from the sidewalls (32, 42) neighboring the wall section (31, 41) all the way to the at least one powder receiving depression (9), have a height extending all the way to the other half shell (3, 4) or all the way to the guide webs (6) of the other half shell (3, 4) for forming the at least one air supply channel, wherein two side by side neighboring guide webs (6) form an air supply channel, respectively.

3. The powder inhaler (1) according to claim 1, further comprising at least two powder receiving depressions (9), wherein at least one air inlet channel extends to each one of the powder receiving depressions (9), respectively.

4. The powder inhaler (1) according to claim 1, wherein the air swirling structure (5) is formed by an elliptical truncated cone (51) to be arranged in the at least one air supply channel between the guide webs (6) that are neighboring each other and comprising at least one projection (52) that extends in a spiral shape along a wall surface of the elliptical truncated cone (51), or several transverse stays (53) that extend between the guide webs (6) that are neighboring each other, wherein the transverse stays (53) are arranged in both half shells (3, 4) such that in the joined arrangement they extend oppositely oriented relative to each other.

5. The powder inhaler (1) according to claim 4, wherein the truncated cone (51) comprises a base surface and is connected by the base surface to the wall section (31, 41) of one of the half shells (3, 4).

6. The powder inhaler (1) according to claim 4, wherein the elliptical truncated cone (51) is connected by at least one film hinge (16) to the wall section (31, 41) of one of the half shells (3, 4).

7. The powder inhaler (1) according to claim 1, wherein the articulated connection of the half shells (3, 4) is a hinge (15) connecting the sidewalls (32, 42) on one side of the half shells or is a pivot joint (15, 15).

8. The powder inhaler (1) according to claim 7, wherein the pivot joint (15, 15) is arranged in an area between one of the sidewalls (32, 42) and the wall section (31, 41).

9. The powder inhaler (1) according to claim 1, wherein the one or more de-agglomeration structures (17) are formed by a group of profiled elements arranged in a ring shape about a full cylinder structure that extends between the two half shells (3, 4), wherein the one or more de-agglomeration structures (17) are arranged on one of the half shells (3, 4) or several of the de-agglomeration structures (17) are distributed at different locations in the outlet area on each one of the half shells (3, 4), or the one or more de-agglomeration structures (17) are formed by two half structures (17), respectively, and one of the half structures (17) is arranged on each half shell (3, 4), respectively, so that the half structures (17) in the joined arrangement of the half shells (3, 4) form the one or more de-agglomeration structures (17) extending between the two half shells (3, 4).

10. The powder inhaler (1) according to claim 1, further comprising an elastic insert (14), wherein the pricker is a plunger (10) connected to the elastic insert (14), wherein the elastic insert (14) with the plunger (10) is arranged in the half shell (3, 4) without the at least one powder receiving depression (9) in the powder deposition and release area at a location which is positioned opposite the at least one powder receiving depression (9), and the plunger (10) is moveable by the elastic insert (14) in the direction toward the at least one powder receiving depression (9).

11. The powder inhaler (1) according to claim 1, wherein the opening is formed by a cutout (32) on the sidewall of a first one of the half shells (3, 4) at the level of the powder receiving depression (9), wherein a width and a height of the cutout corresponds to a width and a height of a blister element (100) dimensioned for reception into the powder inhaler (1), wherein a second one of the half shells (3, 4) comprises a projection (32) on the sidewall (42) that, in a joined arrangement of the half shells (3, 4), is positioned above the cutout (32), wherein the projection (32) is designed to close off the cutout (32) when a blister element (100) is received in the powder inhaler (1).

12. The powder inhaler (1) according to claim 11, wherein the sidewalls (32, 42) of the half shells (3, 4) arranged opposite the cutout (32) and opposite the projection (32) comprise a ribbing (18) at the level of the powder receiving depression (9), wherein a width of the ribbing corresponding to a width of a blister element (100) dimensioned for reception in the powder inhaler (1).

13. The powder inhaler (1) according to claim 11, wherein the first half shell (3, 4) comprises a projection that is designed to engage a corresponding cutout (103) of the blister element (100) dimensioned for reception in the powder inhaler (1).

14. The powder inhaler (1) according to claim 13, wherein the projection is a dome-shape projection.

15. The powder inhaler (1) according to claim 11, wherein the first half shell (3, 4) comprise at least one stop (12) arranged for framing a blister element (100) when inserted in the powder inhaler (1).

16. The powder inhaler (1) according to claim 1, wherein the half shells (3, 4, 15) comprise locking means for releasably joining the half shells (3, 4).

17. A powder inhalation set (1, 100) comprising a powder inhaler (1) according to claim 11 and a blister element (100) dimensioned for reception in the powder inhaler (1), wherein the blister element (100) comprises a support film with at least one depression (101) that is formed for receiving at least one active ingredient powder that is inhalable, and a cover plate that closes off the depression (101), wherein the at least one depression (101) of the blister element (100) in size and position is formed to be received in a powder receiving depression (9) of the powder inhaler (1).

18. The powder inhalation set (1, 100) according to claim 17, wherein, for opening the depression (101), the cover plate is designed to be removable from the support plate through the opening at the level of the powder receiving depression (9) of the powder inhaler (1), and/or the cover plate is penetrable by the pricker embodied as a plunger (10), which is arranged opposite the powder receiving depression (9) and is elastically moveable.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) In this context, it is shown in:

(2) FIG. 1 a perspective view of the powder inhaler according to the invention of two half shells that are connected to each other by a hinge in open state with connected air swirling structure;

(3) FIG. 2 a view according to FIG. 1 with inserted blister;

(4) FIG. 3 a perspective view of the powder inhaler of FIG. 1 with inserted air swirling structure,

(5) FIG. 4 a longitudinal section view of the closed powder inhaler without blister;

(6) FIG. 5 a perspective view of the two half shells of a further powder inhaler according to the invention with pivot joint connection;

(7) FIG. 6 a perspective view of the powder inhaler with two half shells of FIG. 5 in half-open position;

(8) FIG. 7 a longitudinal section view of the powder inhaler of FIG. 6 in closed state without blister;

(9) FIG. 8 schematic plan view of the air swirling structure of transverse stays of the powder inhaler of FIGS. 6/7;

(10) FIG. 9 a perspective plan view of the powder inhaler according to the invention in closed state with mouthpiece as outlet;

(11) FIG. 10 a perspective plan view of a powder inhaler according to the invention in closed state with nose piece as outlet.

DESCRIPTION OF PREFERRED EMBODIMENTS

(12) The device according to the invention relates to a powder inhaler for inhaling delivery through mouth or nose of an active ingredient in powder form which is stored in a blister, wherein the active ingredient may be a medicament but also an active ingredient which is not necessarily defined as a medicament and which is inhaled by a person.

(13) FIG. 1 shows two half shells 3, 4 of a powder inhaler 1 according to the invention for inhaling delivery, wherein the half shells 3 and 4 are connected by a hinge 15 in an articulated manner. One of the half shells, presently the lower half shell 4, is connected by a film hinge 16 with a spiral-like air swirling structure 5 which is comprised of an elliptical truncated cone-shaped base member 51 about which a projection 52 is winding so that the air stream from the inlet openings 8 must follow the spiral 52 and therefore is caused to rotate and be turbulent. After folding the air swirling structure 5 into the space between the guide webs 6 (compare FIG. 3), the half shells 3, 4 in the folded state form the ready to use powder inhaler. In order to transfer the powder inhaler 1 into the ready to use state, the blister element 100 is inserted into a place provided for this purpose (compare FIG. 2). After folding in the air swirling structure 5 and folding closed the two half shells 3 and 4 (compare FIG. 4), the powder inhaler 1 is ready to use; only the medicament depression 101 of the blister element 100 must be opened.

(14) FIGS. 5 to 8 show a further powder inhaler 1 according to the invention with an alternative air swirling structure 5 and a pivot joint 15, 15 as an articulated connection of the two half shells 3 and 4. In this context, the air swirling structure 5 is formed by transverse stays 53 which extend in a zigzag line between the guide webs 6 of each half shell 3, 4 so that the transverse stays 53 in the joined arrangement of the half shells 3, 4 cross each other (compare FIG. 8) and thereby guide the air stream from the air inlet openings 8 alternatingly into the lower half shell 4 and the upper half shell 3 with respective directional change so that turbulences are also generated here.

(15) FIG. 9 shows a powder inhaler 1 in the folded closed state in which the outlet is formed as a spout 20 as in FIGS. 1 to 8. Generally, it is however conceivable for both embodiments of the powder inhaler 1 to form the outlet as a nose tube 21, as illustrated in FIG. 10.

(16) All powder inhalers 1 according to the invention can be divided roughly into three partial areas: the air supply area which extends from the back wall 31 provided with air inlets 8, i.e., the wall present on the base of the half shell 3 and facing away from the outlet area, all the way to the blister chamber 11 and which comprises the funnel-shaped air supply channel provided with the air swirling structure 5 and delimited by the guide webs 6, and the powder deposition and release area which comprises the blister chamber 11 with the powder receiving depression 9 in which active ingredient depression 101 of a blister element 100 can be received; the outlet area with respective de-agglomeration structures 17, 17 and a formed mouthpiece or nose piece.

(17) The configuration according to the invention of the three partial areas ensures that, upon inhalation, an optimal air stream for delivery of the active ingredient, in the following also referred to as medicament, is generated, independent of the way the patient is inhaling. In this way, the medicament can be optimally inhaled and thereby best possible effect achieved.

(18) The air supply area in the embodiments illustrated in the figures is formed by the air supply channel which is delimited by the guide webs 6 and is tapering toward the powder receiving depression 9 into which air is flowing in through the air inlets 8 when the patient breathes in with the mouth piece 20 received in the mouth. The air inlets 8 are provided in the back wall 31 of the half shell 3 as well as at the contact surface of the back walls 31, 41 between both half shells 3, 4 (compare FIG. 5). The tapering air supply channel and the air swirling structure 5 respectively arranged therein cause turbulence and increase the speed of the air supply stream prior to entry into the powder receiving depression 9.

(19) Of course, the number of air supply channels and air swirling structures which are arranged therein in other embodiments, in particular also in embodiments with more than one powder receiving depression, can be varied by appropriate increase of the number of guide webs.

(20) For arranging the blister 100 (compare FIG. 2.), the half shell 4 in one sidewall 42 has a cutout 32 through which the inserted blister 100 with folded over pulling tab 102 of the cover film of the blister element 100 is extending. This cutout 32 is air-tightly closed by the projection 32 at the other half shell 3. The active ingredient depression 101 of the blister 100 which can also be referred to as a capsule is received in the depression 9 which is formed in the half shell 4. For position-precise arrangement of the blister 100, stops 12 are moreover provided in the half shell 4.

(21) For securing the blister element 100 so as to be immobile in the powder inhaler 1 when, for opening the active ingredient depression 101, one pulls on the section 102 of the cover film of the blister element 100 projecting out of the powder inhaler 1, the end of the support plate of the blister element 100 which is facing away therefrom is received between the sidewall sections 32, 42 of the half shells 3, 4 opposite the cutout 32 and the projection 32. For this purpose, this section of the sidewalls 32, 42 is provided with ribbing 18.

(22) For guiding the air stream through the inserted, open active ingredient depression 101, at appropriate location in the half shell 3, on both sides of the powder receiving depression 9 or the active ingredient depression 101, guide walls 7 are arranged (FIG. 1, FIG. 7) which extend away from the longitudinal webs 6 and guide the airstream out of the air inlet area through the powder receiving depression 9 or the open depression 101 of the blister element 100 arranged therein and filled with powder.

(23) The blister chamber 11 is adjoined by the outlet area through which the now formed aerosol of air and medicament powder is released. The blister chamber 11 in the outlet area is delimited by the de-agglomeration structures 17, 17 by means of which the air stream, now laden with the active ingredient, cannot directly reach the outlet but, due to the further deflection, turbulences are generated in order to prevent deposition or agglomeration of the powder medicament. However, downstream of the passage through the powder receiving depression 9 narrowly delimited by the guide walls 7, a cross-sectional widening initially causes a reduction of the flow speed and creates in this way a spacer effect, i.e., the active ingredient particles are distributed uniformly within the air stream. The de-agglomeration of the active ingredient particles is subsequently enhanced on the other hand by the de-agglomeration structures 17, 17 in the outlet end that is tapering by means of the wall sections 22 and provided with mouthpiece 20.

(24) In the figures, the powder inhalers 1 each have three de-agglomeration structures 17, 17 wherein in the embodiment in FIGS. 1 to 4 a de-agglomeration structure 17 is arranged in the lower half shell 4 and two de-agglomeration structures 17 in the upper half shell 3. Generally, it is however also possible to provide more or fewer de-agglomeration structures; also, they can all be provided in one of the half shell or distributed differently on the two half shells.

(25) The or each de-agglomeration structure 17, 17 in the outlet area can be formed by a group of profiled elements, e.g. lamellas, that are arranged in a ring shape about a cylinder. These lamellas can have an airfoil-like profile in order to impart defined turbulence to the air stream.

(26) In the embodiment according to FIGS. 5 to 7, the three de-agglomeration structures are each formed by two half structures 17 in each of the half shells 3, 4. The half structures 17 extend only to the partition plane defined by the half shells 3, 4 so that they can be pivoted about the pivot joint 15 and cutout 15. Generally, in this embodiment care must taken that none of the elements and structures in the interior of the half shells 3, 4, also the guide walls 7 and the transverse stays 53, project past the partition plane. For this reason, the sidewall 32 of the half shell 3 also does not have a projection relative to the cutout 32 at the sidewall 42 of the half shell 4; the cutout 32 is therefore designed with a reduced depth so that the half shells 3, 4 seal tightly at this location with inserted blister element. Only the section of the sidewall 32 or half shell 3 with ribbing 18 projects past the partition plane and the corresponding section with the ribbing 18 at the sidewall 42 of the lower half shell 4 is appropriately lowered.

(27) This arrangement is associated with pivoting of the upper half shell 3 for opening in clockwise direction and for closing in counterclockwise direction. If the ribbed projection were provided at the lower half shell and an appropriately lowered ribbed section at the upper half shell, the pivot directions for opening and closing would be exactly reversed. In order to make the use of the device easy for the user, appropriate information, for example, markings by arrows, can be provided on the exterior side of the half shells.

(28) A powder inhaler 1 comprised of two half shells 3 and 4 according to the invention can advantageously be produced quickly and inexpensively by injection molding of a plastic material. All required structures are positioned in the half shells or, in case of the truncated cone shaped spiral, are formed as one piece with one of the half shells. The assembly of the half shells at the longitudinal hinge or the pivot joint is not complicated; no further individual parts are required.

(29) Advantageously, the powder inhaler 1 of two half shells 3, 4, after insertion of a blister element 100 in the open state, can be easily transferred by folding or pivoting into the ready to use state. Due to the flat configuration, the powder inhaler 1 can be carried along in a simple and comfortable way without pockets of clothing being excessively bulged. When administration of the medicament is required, it is only necessary to pull off the end section 102 for opening the powder depression 101 and the medicament can be inhaled.

(30) As can be seen in FIGS. 1 to 4, moreover an additional or alternative opening mechanisms for the active ingredient depression 101 of a blister element 100 can be provided which comprises a plunger 10 that is designed as a pricker. The pricker 10 is secured in the half shell 3 by an elastic insert 14 which has a curvature 14 in outward direction (see FIG. 4) and which indicates to the user the pressure point that must be actuated in order to penetrate an inserted blister depression 101 with the pricker 10. After actuation of the pressure point by the user, the pricker 10 is returned again by the elastic insert 14 into its initial position and deflects moreover the air stream into the powder receiving depression or the active ingredient depression. The manufacture of this powder inhaler can be realized in that first the elastic insert 14 is injection molded and the remaining inhaler shape is injection molded onto the elastic insert 14, or vice versa, for example, by a 2C injection molding method. Of course, a powder inhaler with longitudinal hinge and insertable air swirling structure can also be formed without plunger so that opening of the active ingredient depression is realized only by pulling off the pulling tab of the cover film of the blister element that is projecting out off the powder inhaler.

(31) Moreover, FIG. 4 shows in longitudinal section view that the air supply channel not only tapers in regard to width but also to height in the direction toward the blister chamber 11 wherein the wall thickness of the half shells 3 and 4 is increased at the same time. The air stream which is entering through the air inlets 8 is caused to rotate (similar to a tornado) along the coil-shaped or spiral-shaped path that is predetermined by the air swirling structure 5. By rotation centrifugal forces and pressure phenomena are generated which are important for the complete entrainment of the powder out of the powder receiving depression 9.

(32) TABLE-US-00001 List of Reference Numerals 1 powder inhaler 3 first half shell 4 second half shell 5 air swirling structure 6 guide web 7 guide wall 8 air inlet opening 9 powder receiving depression 10 plunger 11 blister chamber 12 stop 14, 14 elastic insert with pressure dome 15, 15 pivot joint 15 longitudinal hinge 16 film hinge 17 de-agglomeration structure 17 half structure 18 ribbing 20 mouthpiece 21 nose tube 22 outlet wall 31, 41 back wall of the half shells 32, 42 sidewall of the half shells 32 cutout 32 projection 51 elliptical truncated cone 52 spiral-shaped projection 53 transverse stay 100 blister 101 active ingredient depression 102 folded over pulling tab of the cover film