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 are connected to each other by means of at least one film hinge and are formed as a single piece. In a joined arrangement, the two half-shells (3, 4) enclose an air inlet region, a powder deposition region and powder release region, and an outlet region, through which regions a fluid path extends, wherein at least one of the half-shells (3, 4) has at least one air inlet opening (8) in the air inlet 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: a first half shell and a second half shell (3, 4) that are connected to each other by at least one film hinge (16), the first and second half shells and the at least one hinge formed as one piece, wherein the first and second half shells (3, 4) in a joined arrangement, in which the first and second half shells are folded onto each other, enclose an air inlet area, a powder deposition and release area, and an outlet area through which a fluid path is extending; wherein at least one of the first and second half shells (3, 4) in the air inlet area comprises at least one air inlet opening (8); wherein the first half shell comprises one or more powder receiving depressions (9) in the powder deposition and release area, wherein the one or more powder receiving depressions (9) are configured to receive a depression (101) of a blister element (100) dimensioned to be received in the powder inhaler (1), the blister element (100) comprising a support film in which the depression (101) containing at least one active ingredient powder that is inhalable is formed and comprising a cover plate closing off the depression (101); wherein the outlet area comprises one or more de-agglomeration structures (17, 17) and an outlet for aerosol that is formed by the first and second half shells (3, 4); wherein the first and second half shells (3, 4) are flat and comprise an elongate substantially rectangular, trapezoidal, drop-shaped or oval base that is rimmed by sidewalls (32, 42) and a wall section (31, 41) that is opposite the outlet; wherein the at least one air inlet opening (8) is arranged on the wall section (31, 41); wherein on at least one of the first and second half shells (3, 4) two or more guide webs (6) are provided and extend in a fan shape from the wall section (31, 41) and/or from the sidewalls (32, 42) adjacent to the wall section (31, 41) all the way to the at least one powder receiving depression (9), wherein the guide webs (6) on the at least one of the first and second half shells (3, 4) have a height extending all the way to the other half shell (3, 4) or to the guide webs (6) provided on the other half shell (3, 4), wherein two side by side neighboring guide webs (6) form an air supply channel and delimit the fluid path in the air inlet area, respectively, wherein the air supply channels each comprise a cross-section that is tapering toward the one or more powder receiving depressions (9); wherein the one or more powder receiving depressions (9) are framed along the fluid path on two sides by guide walls (7) which extend away from the guide webs (6) that are outermost guide webs of the fan shape and lead to the one or more powder depressions (9); wherein the powder inhaler is further configured such that: in the powder deposition and release area, the second half shell comprises, at a location which is positioned opposite the one or more powder receiving depressions (9), a plunger (10) that is elastically moveably inserted in the second half shell in the direction toward the one or more powder receiving depression (9), wherein the plunger (10) is a pricker for opening an active ingredient depression (101) of a blister element (100) when inserted into the powder inhaler (1), and/or on one of the first and second half shells (3, 4) one of the sidewalls (32, 42) at the level of the one or more powder receiving depressions (9) comprises a cutout (32) having a width and a height corresponding to a width and a height of a blister element (100) dimensioned to be received in the powder inhaler (1), wherein on the sidewall (32, 42) that, in the joined arrangement, is positioned above the cutout (32), the other one of the first and second half shells (3, 4) that does not have the cutout (32) comprises a projection (32) that closes off the cutout (32) when a blister element (100) is inserted into the powder inhaler (1).

2. The powder inhaler (1) according to claim 1, wherein the powder inhaler (1) is an injection molded part.

3. The powder inhaler (1) according to claim 1, comprising a plurality of the powder receiving depressions, wherein at least one of the air supply channels extends to each one of the powder receiving depressions (9).

4. The powder inhaler (1) according to claim 1, further comprising air swirling structures wherein the air supply channels each have at least one of the air swirling structures arranged therein.

5. The powder inhaler (1) according to claim 4, wherein the air swirling structures each are formed by a plurality of vanes connected to the guide webs (6) and projecting from the guide webs (6) into the air supply channels, respectively.

6. The powder inhaler (1) according to claim 5, wherein the vanes (5) are alternatingly arranged on two oppositely positioned ones of the guide webs (6) and/or on side by side neighboring ones of the guide webs (6), respectively, and form obstacles for an air stream that is flowing along the fluid path.

7. The powder inhaler (1) according to claim 6, wherein the outlet is formed as a mouthpiece or a nose piece.

8. The powder inhaler (1) according to claim 7, wherein the mouthpiece is formed as a spout (20) or the nose piece is formed as a curved nose tube (21).

9. The powder inhaler (1) according to claim 8, wherein at least one of the de-agglomeration structures (17) is formed by webs (17) that extend from oppositely positioned wall sections (22) of the outlet area into the fluid path.

10. The powder inhaler (1) according to claim 9, wherein the webs (17) projecting into the fluid path are alternatingly arranged on the wall sections (22) of the outlet area.

11. The powder inhaler (1) according to claim 1, wherein at least one of the de-agglomeration structures (17) adjoins the powder deposition and release area and is formed by at least one deflection web (17) arranged in one of the first and second half shells (3, 4).

12. The powder inhaler (1) according to claim 11, wherein the at least one deflection web (17) is arranged in the first half shell.

13. The powder inhaler (1) according to claim 1, further comprising an elastic insert to which the plunger (10) is connected, wherein the elastic insert with the plunger is inserted into the second half shell so that the plunger is movable in a direction toward the one or more powder receiving depressions (9).

14. The powder inhaler (1) according to claim 1, wherein the first half shell comprises at least one stop that is provided for framing a blister element (100) when inserted into the powder inhaler (1).

15. The powder inhaler (1) according to claim 1, wherein the first and second half shells (3, 4) have a ribbing (18) at the sidewalls (32, 42) opposite the cutout (32) and the projection (32), wherein the ribbing (18) is arranged at the level of the one or more powder receiving depressions (9).

16. The powder inhaler (1) according to claim 1, wherein the first half shell has a projection that is configured to engage a corresponding cutout (103) of a blister element (100) when inserted into powder inhaler (1).

17. The powder inhaler (1) according to claim 16, wherein the projection is dome-shaped.

18. The powder inhaler (1) according to claim 1, further comprising at least one third half shell (15) connected by at least one hinge (16) to the first half shell or the second half shell.

19. The powder inhaler (1) according to claim 18, wherein the at least one third half shell (15) is connected to that one of the first and second half shells that does not comprise the at least one air inlet (8).

20. The powder inhaler (1) according to claim 18, wherein the third half shell (15) comprises a base corresponding to a shape of the base of the first and second half shells (3, 4) and having a size configured to store at least one blister element (100) dimensioned to be received in the powder inhaler (1).

21. The powder inhaler (1) according to claim 18, wherein the third half shell (15) comprises locking means for locking the third half shell (15) on at least one of the first and second half shells (3, 4).

22. The powder inhaler (1) according to claim 1, comprising locking means for locking the first and second half shells (3, 4) to each other.

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

24. The powder inhalation set (1, 100) according to claim 23, wherein, for opening the depression (101), the cover plate is designed to be removable from the support plate through the cutout (32) in the sidewall (32, 42) of the powder inhaler at the level of the powder receiving depression (9) of the powder inhaler, and/or the cover plate is penetrable by the plunger (10), which is arranged in the second half shell (3, 4) of the powder inhaler (1) opposite the one or more powder receiving depression (9) and is elastically moveable.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Further embodiments as well as some of the advantages that are associated with these and further embodiments will become more clear and easier to understand with the aid of the following detailed description referencing the attached figures. Elements or parts thereof which are substantially identical or similar can be provided with the same reference characters. The figures are only a schematic illustration of an embodiment of the invention. In this context, it is shown in:

(2) FIG. 1a and FIG. 1b perspective views of powder inhalers according to the invention for inhaling delivery through the mouth in open state, comprising in FIG. 1a) a ribbing FIG. 1b) a dome-shaped projection as abutment;

(3) FIG. 2a and FIG. 2b views according to FIGS. 1a) and 1b) with inserted blister;

(4) FIG. 3 a perspective view of the powder inhaler of FIG. 1a and FIG. 1b in closed state;

(5) FIG. 4 a perspective longitudinal section of the powder inhaler of FIG. 3;

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

(7) FIG. 6 a longitudinal section view of a further powder inhaler according to the invention for nasal delivery in closed state without blister;

(8) FIG. 7 a perspective view of the powder inhaler of FIG. 6;

(9) FIG. 8 a perspective view of the powder inhaler of FIGS. 6 and 7 in open state;

(10) FIG. 9 a plan view of the powder inhaler of FIGS. 6 to 8.

DESCRIPTION OF PREFERRED EMBODIMENTS

(11) 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.

(12) FIGS. 1a) and b) show powder inhalers 1 according to the invention for inhaling delivery in open state, comprised of two half shells 3 and 4 which in the folded closed state form a ready to use powder inhaler. The two powder inhalers 1 differ only with regard to the embodiment of the abutment for holding the blister element when pulling off the cover film. In the illustrated form, the powder inhaler 1 can be produced advantageously quickly and inexpensively as one piece with a single tool by injection molding of plastic material, for example. In order to convert the powder inhaler 1 into the ready to use state, a blister element 100 is inserted at a location provided for this purpose(see FIGS. 2a, b). After folding closed the two half shells 3 and 4 and opening of the medicament depression 101 of the blister element 100, the powder inhaler 1 is ready to use (FIG. 3).

(13) The powder inhaler 1 can be divided roughly into three partial areas: the outlet area with de-agglomeration structures 17, 17 which is formed as a mouthpiece in the embodiment illustrated in FIGS. 1 to 5, 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 channels separated 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 a blister element 100 with an active ingredient depression 101 can be received.

(14) 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 formed, independent of the way the patient is inhaling. In this way, the medicament can be optimally inhaled and thereby best possible action achieved.

(15) The air supply area in the examples illustrated in the figures is provided by three air supply channels that taper in the direction toward the powder receiving depression 9 and are delimited by guide webs 6 and into which through the air inlets 8 air is flowing in when the patient is inhaling through 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 the two half shells 3, 4 (compare FIG. 4). In each air supply channel, air swirling structures in the form of vanes 5 (deflection vanes 5) are arranged and are each projecting from the guide webs 6 of both half shells 3, 4 into the channels. The tapering air supply channels and the deflection vanes 5 provide turbulence and increase the speed of the air supply stream prior to entering the powder receiving depression 9.

(16) Of course, the number of the air supply channels in other embodiments, in particular also in embodiments with more than one powder receiving depression, can be varied.

(17) For arranging the blister 100 (compare FIG. 2a) and b), the half shell 4 has in a sidewall 42 a cutout 32 through which the inserted blister 100 is extending with a folded over pulling tab 102 of the cover film of the blister element 100. 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 element 100, which can also be referred to as capsule, is located in the depression 9 formed in the half shell 4. While FIGS. 1a) and 2a) show an embodiment in which the blister element 100 is secured by ribbing 18 in the sidewalls 32, 42 relative to the cutout 32 and the projection 32 in the half shells 3, 4, when the powder inhaler 1 is closed, the abutment of the powder inhaler 1 in FIGS. 1b) and 2b) is formed by a dome-shaped projection 18 positioned adjacent to the powder receiving depression 9 and penetrating an appropriately positioned opening 103 of the blister element 100 and ensuring a securing action immobilizing the blister element 20 in the powder inhaler 1 when, for opening the active ingredient depression 101, one pulls at the section 102 of the cover film of the blister element 100 (compare FIG. 3) that is projecting from the powder inhaler 1.

(18) For a position-precise arrangement of the blister element 100, moreover the stops 12 are provided in the half shell 4. The deflection web 17 functioning as a de-agglomeration device further assists in positioning the blister element 100.

(19) For guiding the air stream through the active ingredient depression 101 that is inserted into powder receiving depression 101 and is opened, guide walls 7 (FIG. 1) are provided at an appropriate location in the half shell 3 and extend from the outermost guide webs 6, when the powder inhaler 1 is closed, all the way to the blister element 100 so that the air stream is guided out of the air inlet area through the powder receiving depression 9 and the open powder-filled depression 101 of the blister element 100 arranged therein.

(20) The outlet area adjoins the blister chamber 11 and the now formed aerosol of air and medicament powder is delivered via it. The blister chamber 11 is delimited relative to the outlet area by the de-agglomeration device 17 which, together with the further de-agglomeration devices 17, prevents the air stream laden with the active ingredient from directly reaching the outlet in that turbulences are generated by deflections in order to de-agglomerate the powder and to prevent renewed deposition or agglomeration of the medicament powder. However, downstream of the passage narrowly delimited by the guide walls 7, a cross-sectional widening, effected by the powder receiving depression upstream of the deflection by de-agglomeration device 17, first 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. Subsequently, the de-agglomeration of the active ingredient particles is enhanced by the vane-shaped webs 17 projecting into the fluid path as de-agglomeration devices in the tapering mouthpiece 20. Generally, de-agglomeration devices can also be formed by other structures than the here illustrated webs 17, 17, for example, cyclones or bollards, as long as the structures ensure swirling of the air stream after having passed the powder receiving depression.

(21) In an advantageous simple way, the powder inhaler 1 comprised of the two half shells 3, 4 that are connected by a film hinge 16 can be transferred into the ready to use state by folding after insertion of the blister element 100 in the open state. Due to the flat configuration, the powder inhaler 1 can be carried along in a simple and comfortable way without pockets on clothing bulging excessively. When administration of the medicament is required, pulling off the end section 102 for opening the powder depression 101 or penetration of the cover film is required and the medicament can be inhaled.

(22) In order to be able to carry along in a simple way additional blisters, in the present example it is provided that a further half shell 15 is connected by means of film hinges 16 to the half shell 4. Generally, it is however also possible that this storage half shelf 15 is arranged also on the half shell 3. In this case, the air inlets 8, which in the illustrated example are present at the back wall 31 of the half shell 3, should be arranged in the other half shell 4. When the storage half shell 15 is pivoted onto the half shell 4, as shown in FIG. 4, a storage space 19 is delimited in which, for example, additional blisters can be carried along. Moreover, the gripping ergonomics when holding the powder inhaler 1 can be improved by the storage half shell 15.

(23) In an embodiment that is not illustrated, in place of a third half shell a swirling structure, or several swirling structures, can be connected by means of a hinge and can positioned by folding into the air channel/air channels.

(24) As can be seen in FIGS. 1 to 5, an alternative mechanisms, comprising a plunger 10 embodied as a pricker, for opening the active ingredient depression 101 of the blister element 100 can be provided instead of pulling off the cover film. The pricker 10 is secured by an elastic insert 14 in the half shell 3 wherein the elastic insert has an outwardly curved portion 14 which is indicating to the user the pressure point that must be actuated in order to penetrate the cover film of the blister depression 101 of the inserted blister element 100 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. Advantageously, the plunger 10 in this position guides the turbulent air stream out of the air inlet area into the powder receiving depression 9, or the active ingredient depression 101 contained therein. 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 then injection molded onto the elastic insert 14, or vice versa, for example, by a 2C injection molding process.

(25) It is possible that the powder inhaler according to the invention comprises both opening mechanisms, i.e., a plunger and an abutment, comprised of ribbing or bollards, in order to be able to open different blister types; however, it may also be sufficient when a powder inhaler according to the invention comprises only one of the alternatives.

(26) As can be seen in the sectioned side view of FIG. 5, the air supply channels taper not only in regard to their width but also in regard to their height in the direction toward the blister chamber 11 wherein the wall thickness of the half shells 3 and 4 increases correspondingly. The vanes 5 projecting into the air inlet channels provide for a worm-shaped or spiral-shaped path which causes the airstream to rotate (similar to a tornado). Due to the 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. Particularly effective in this context are oppositely oriented swirls that can be obtained, for example, by the central and right air supply channel in FIG. 9.

(27) The additional FIGS. 6 to 9 represent a further exemplary embodiment of the powder inhaler 1 according to the invention that is provided for nasal delivery. Therefore, the outlet is designed as a curved nose tube 21. In other respects, this powder inhaler 1 for nasal delivery corresponds mostly in configuration and function to the afore described powder inhaler 1 for inhaling delivery through the mouth, however, without the movable plunger. In this powder inhaler, opening of the active ingredient depression of the blister element is thus performed by pulling off the cover plate. Opposite the powder receiving depression 9, the half shell 3 has a thicker wall portion 34 between the guide walls 7 in order to avoid at this location a cross-sectional increase and to guide the turbulent air stream out of the air supply area into the powder receiving depression 9 or to the active ingredient depression received therein.

(28) Of course, a powder inhaler with nose piece can also be embodied with an elastically supported plunger for perforation of the blister. Generally, the elements (ribbing or projection) serving as abutments for the pulling off action, as well as the cutout and the corresponding projection in the sidewalls can be eliminated when only the plunger is to be used for opening the blister.

(29) Finally, it is not precluded that a powder inhaler according to the invention can also can be used without blister element in that, in the open state of the powder inhaler, a powder dose is directly introduced into the powder receiving depression and inhaled immediately after folding together the half shells.

LIST OF REFERENCE NUMERALS

(30) 1 powder inhaler 3 first half shell 4 second half shell 5 swirling structure, vane 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 storage half shell 16 film hinge 17, 17 de-agglomeration devices 18 ribbing on sidewall 18 dome-shaped projection 19 storage space 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 34 thicker wall portion opposite powder receiving depression 100 blister 101 active ingredient depression 102 folded over pulling tab of the cover film 103 positioning opening