Single-Dose Powder-Medication Inhaler
20200230334 ยท 2020-07-23
Inventors
Cpc classification
A61M15/0028
HUMAN NECESSITIES
A61M15/0043
HUMAN NECESSITIES
A61M2205/0205
HUMAN NECESSITIES
A61M2206/14
HUMAN NECESSITIES
International classification
Abstract
The present invention provides a single-dose powder-medication inhaler (10) for nasal application, comprising a flat inhaler housing consisting of two flat housing parts (1, 2) connected to one another along a connecting plane (E). Formed in the two flat housing parts are: a medication chamber (11) having at least one powder receiving hollow (11); an air inlet opening (14); and an air channel delimited by walls (7), the air channel extending from the air inlet opening (14), via the medication chamber (11) to a discharge opening (12). According to the invention the air inlet opening (14) does not lie on a side facing away from the discharge opening (12), whereby the air channel provides a direction change of an air flow through the air inlet opening (14) relative to the discharge opening (12). The outlet section (13) of the air channel between the medication chamber (11) and the discharge opening (12) has more than one bend (6). Furthermore a nose piece (4), designed for inserting in only one nostril or in both nostrils, is formed on the discharge opening (12).
Claims
1.-9. (canceled)
10. A single-dose powder inhaler (10) for nasal application, the single-dose powder inhaler comprising: a flat inhaler housing comprised of two planar housing parts (1, 2) connected to each other along a connecting plane (E) and comprising, integrally formed therein as shaped regions, a medicament chamber (11) with a powder-receiving hollow (11), an air inlet opening (14), an outlet opening (12), and an air channel delimited by a wall (7) and extending from the air inlet opening (14) via the medicament chamber (11) to the outlet opening (12); a nosepiece (4), configured to be received in a nostril or in both nostrils, integrally formed at the outlet opening (12); wherein the air inlet opening (14) is not arranged on a side of the inhaler housing facing away from the outlet opening (12); wherein the air channel is configured to cause an air flow flowing from the air inlet opening (14) to the outlet opening (12) to undergo a directional change; wherein the air channel comprises an outlet portion (13) arranged between the medicament chamber (11) and the outlet opening (12), wherein the outlet portion (13) comprises first windings and no deagglomerating structure.
11. The single-dose powder inhaler (10) as claimed in claim 10, wherein the air inlet opening (14) and the outlet opening (12) are arranged in a neighboring position next to each other or are arranged offset from each other by 90 or by an angle between 90 and the neighboring position.
12. The single-dose powder inhaler (10) as claimed in claim 10, wherein the air inlet opening (14) and the outlet opening (12) are arranged next to each other perpendicularly to or parallel to the connecting plane (E) of the housing parts (1, 2).
13. The single-dose powder inhaler (10) as claimed in claim 10, wherein one of the air inlet opening (14) and the outlet opening (12) is arranged parallel to the connecting plane (E) of the housing parts (1, 2) and the respective other one of the air inlet opening (14) and the outlet opening (12) is arranged perpendicularly to the connecting plane (E) of the housing parts (1, 2).
14. The single-dose powder inhaler (10) as claimed in claim 10, wherein the outlet portion (13) of the air channel is a meandering channel and the first windings include at least three curves, or the outlet portion (13) of the air channel comprises a spiral-shaped channel with at least two of the first windings.
15. The single-dose powder inhaler (10) as claimed in claim 10, further comprising at least one tear-off film element (3) comprising a closure tab (30) closing the powder-receiving hollow (11) in the medicament chamber (11) and further comprising a tear-off tab (31) which extends away from the closure tab (30) out of the medicament chamber (11) and out of the air inlet opening (14) by passing through an inlet portion (18) of the air channel that is disposed between the air inlet opening (14) and the medicament chamber (11).
16. The single-dose powder inhaler (10) as claimed in claim 15, wherein the inlet portion (18) of the air channel comprises a powder-retaining structure (15), wherein the powder-retaining structure (15) narrows a channel cross section of the air channel and is at least one barrier (15) that extends into the air channel transversely to a flow direction of the air flow.
17. The single-dose powder inhaler (10) as claimed in claim 15, wherein the inlet portion (18) of the air channel comprises second windings such that the air flow guided through the inlet portion (18) changes the flow direction several times.
18. The single-dose powder inhaler (10) as claimed in claim 10, further comprising at least one tear-off film element (3) comprising a closure tab (30) closing the powder-receiving hollow (11) in the medicament chamber (11) and further comprising a tear-off tab (31) which extends away from the closure tab (30) out of the medicament chamber (11) and out of a tab opening (16) by passing through a tab channel (17) which extends between the tab opening (16) and the medicament chamber (11).
19. The single-dose powder inhaler (10) as claimed in claim 18, wherein the tab channel (17) comprises a powder-retaining structure (15), wherein the powder-retaining structure (15) narrows a channel cross section of the tab channel (17) and is at least one barrier (15) that extends into the tab channel (17) transversely to a flow direction of the air flow.
20. The single-dose powder inhaler (10) as claimed in claim 10, wherein the medicament chamber (11) comprises two or more of said powder-receiving hollow (11), wherein the two or more of said powder-receiving hollow (11) each contain a partial dose of a pulverulent medicament.
21. The single-dose powder inhaler (10) as claimed in claim 20, further comprising a tear-off film element (3) for each one of the two or more of said powder-receiving hollow (11), wherein the tear-off film element comprises a closure tab (30) closing the respective powder-receiving hollow (11) and further comprising a tear-off tab (31) which extends away from the closure tab (30) out of the medicament chamber (11) to an exterior of the flat inhaler housing.
22. The single-dose powder inhaler (10) as claimed in claim 20, further comprising a tear-off film element (3) for the two or more of said powder-receiving hollow (11), wherein the tear-off film element comprises a closure tab (30) closing the two or more of said powder-receiving hollow (11) and further comprising a tear-off tab (31) which extends away from the closure tab (30) out of the medicament chamber (11) to an exterior of the flat inhaler housing.
23. The single-dose powder inhaler (10) as claimed in claim 10, wherein the housing parts (1, 2) are plate elements connected to each other in a planar manner in the connecting plane (E) outside the shaped regions.
24. The single-dose powder inhaler (10) as claimed in claim 10, wherein the housing parts (1, 2) are shell elements with circumferential edges (9) connected to each other in the connecting plane (E) at least at the circumferential edges (9).
25. The single-dose powder inhaler as claimed in claim 10, wherein the housing parts (1, 2) are injection-molded plastic parts comprised of a plastic material, wherein the plastic material is biodegradable and/or contains a marker and/or is antiseptic and/or antimicrobial.
26. The single-dose powder inhaler as claimed in claim 10, wherein the housing parts (1, 2) are shaped or thermoformed from a pharmaceutically acceptable single-type plastic film, wherein a plastic material of the plastic film is biodegradable and/or contains a marker and/or is antiseptic and/or antimicrobial.
27. The single-dose powder inhaler as claimed in claim 10, wherein the housing parts (1, 2) comprise an antiseptic and/or antimicrobial coating at least along the air channel.
28. The single-dose powder inhaler as claimed in claim 10, wherein at least one of the housing parts (1, 2) is comprised of a transparent plastic material.
Description
[0033] In the figures:
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
[0047]
[0048]
[0049]
[0050]
[0051]
[0052]
[0053]
[0054] The device according to the invention concerns a single-dose powder inhaler which is simple and cost-effective to produce, whose housing consists of only two housing parts and which is optimized for nasal application. The single-dose powder inhaler according to the invention can be embodied in the manner of a visibility or blister pack, wherein one of the housing parts or both of them can be transparent and thus make it possible to see into the powder inhaler, in particular into the medicament chamber. It is thus possible to check the content or the complete emptying of the content after use.
[0055] As is shown in a number of illustrative embodiments in the figures, the housing of a single-dose powder inhaler 10 according to the invention is flat and of small dimensions; the inhaler is so small that it can be imagined as being about the size of a stack of 5 check cards. It can thus be easily carried around in a handbag or even in a coat pocket. The housing consists of two planar housing parts 1, 2 which are connected to each other along a connecting plane E. A medicament chamber 11 with at least one powder-receiving hollow 11 for a dose of pulverulent medicament is formed in the housing parts 1, 2. In the examples shown in the figures, a single powder-receiving hollow 11 is formed in a housing part 1. However, in contrast to what is shown, it is also possible to provide more than one powder-receiving hollow for partial doses or for components that are to be mixed together only at the time of use. A second or further powder-receiving hollow can be formed in the same housing part 1 or in the other housing part 2.
[0056] Moreover, an air inlet opening 14 and an outlet opening 12, and also an air channel delimited by a wall 7 on both sides, are formed in the housing parts 1, 2, which air channel connects the air inlet opening 14 to the medicament chamber 11 and connects the latter to the outlet opening 12. The arrangement of the air inlet opening 14 and of the outlet opening 12 in relation to each other is here chosen in such a way that an air inlet flow direction L.sub.E, which is defined by the arrangement of the air inlet opening 14, does not correspond to the air outlet flow direction L.sub.A, which is defined by the arrangement of the outlet opening 12, such that, in the case of use when the user arranges the outlet opening 12 facing upward at the nostrils, the air inlet opening 14 does not face downward, and therefore no powder can fall out of the air inlet opening 14.
[0057] Moreover, the single-dose powder inhaler 10 according to the invention has an outlet channel portion 13, which extends by more than one winding 6 from the medicament chamber 11 as far as the outlet opening 12, such that the air flow guided through the outlet channel portion 13 is subjected to several changes of direction, and a turbulent air flow is thus generated by which the powder entrained in the medicament chamber 11 is transported in a uniformly distributed manner. Moreover, for the nasal application, no deagglomerating structures are required or desirable in the outlet channel if the powder particles are intended to be deposited in the nasal mucosa and are therefore not intended to be comminuted any further.
[0058] The illustrative embodiments concern a number of variants as regards the arrangement of air inlet opening 14 and outlet opening 12 and also as regards the configuration of the sinuous outlet channel portion 13.
[0059]
[0060] The housing part 1, with the powder-receiving hollow 11 formed in the medicament chamber 11, can be seen clearly in
[0061] Although not shown in the figures, the nosepiece can in principle also have two courses, in order to be used by both nostrils. The air flow from the outlet channel portion 13, which has a widening 12 toward the outlet opening 12 in order to slow down the flow, can in this case be divided into two subsidiary flows.
[0062] The figures do not show nosepiece variants which are designed to be received in one nostril or are designed with two nozzle extensions for both nostrils but still represent nosepieces within the meaning of the invention.
[0063] As is indicated in
[0064] By breathing in through the nose at the nosepiece 4, the user then generates an air flow through the air channel which is provided in the inhaler 10 and which is composed of an inlet channel portion 18, the medicament chamber 11 and the outlet channel portion 13, which are delimited by walls 7. These inner walls 7 of the air channel are also depicted in the figures, although they do not have to be visible from the outside, for example if the inhaler is produced from opaque material.
[0065] The air flow entering through the air inlet opening 14 upon inhalation at the nosepiece passes through the inlet channel portion 18 into the medicament chamber 11 and there entrains the powder, freed after removal of the film element 3, through the outlet channel portion 13, which opens into the outlet opening 12. The outlet channel portion 13 is here designed as a meandering channel with several curves 6. It will be appreciated that a meandering channel within the meaning of the invention can also differ from the depicted course, in terms of the number, curvature, radius and direction of the curves, without departing from the scope of protection.
[0066] Toward the outside, the inlet opening 14 has a funnel-shaped widening 14, especially in relation to the shell base 8 of the housing parts 1, 2, as can be seen from
[0067] On a side of the powder inhaler 10 directed away from the outlet opening 12/nosepiece 4, a ribbed structure 8 is provided on the surface in the shell base 8 of each of the housing parts 1, 2, which ribbed structure 8 serves for an improved grip of the inhaler 10 when it is held by a user.
[0068] For the embodiments described in connection with the further figures, only those features that differ from the example described with reference to
[0069]
[0070] It will be noted that the slit-shaped air inlet opening shown can also be differently configured; instead of a slit, another geometry can be chosen, or further openings are present in the manner of a bypass opening.
[0071] As the block arrows in
[0072] The outlet channel portion 13 of the powder inhaler from
[0073]
[0074] The embodiment of a single-dose powder inhaler 10 according to the invention shown in connection with
[0075] The single-dose powder inhaler 10 shown in
[0076] In
[0077] Except for the mouthpiece, the inhalers described in connection with
[0078] The outlet opening 12 and the inlet opening 14 of the single-dose powder inhaler 10 shown in
[0079]
[0080] In the embodiments described as examples in connection with the figures, the air inlet opening 14 and the outlet opening 12 are in each case arranged in relation to each other in such a way that the air inlet flow direction L.sub.E and the air outlet flow direction L.sub.A run at an angle of 90 to each other or at 180 (oppositely directed). However, it will be appreciated that arrangements can also be provided which differ from this and which lie within the scope of protection of the invention as long as air inlet opening and outlet opening do not lie in the straight-ahead direction but are instead moreover preferably arranged such that the air inlet flow direction L.sub.E and the air outlet flow direction L.sub.A span an angle of at least 90, in order to effectively prevent escape of the powder in the position of use of the inhaler with the outlet opening directed substantially perpendicularly upward.
[0081] Particularly if the inhaler housing does not have a substantially rectangular base (or a shape composed of rounded rectangle and trapezium) as in the examples shown, but instead has, for example, an oval or regular hexagonal shape, the air inlet opening and outlet opening can deviate from the illustrated arrangements with flow directions offset by 90 or 180.
[0082] Moreover, the illustrative embodiments shown in the figures show housing parts with a shell base 8, wherein an outer surface of the housing is substantially plane except for the powder-receiving hollow and the widenings to inlet opening and outlet opening. The figures do not show embodiments of a single-dose powder inhaler according to the invention in which the housing parts are based on a plate base. However, as a person skilled in the art can readily imagine, the corresponding structures in the housing parts are then formed in plate elements instead of in shell elements, such that the structures rise from the flat plate base. While the housing parts 1, 2 on shell base 8 are connected to each other at their edges 9 and at the wall 7 delimiting the air channel and the medicament chamber 11, housing parts on a plate base can be connected to each other in a planar manner in the connecting plane outside the shaped regions.
[0083] The housing parts of a single-dose powder inhaler according to the invention can be welded to each other by heat, but adhesive bonding, clamping connections (wherein the edge of one housing part is bent around the edge of the other housing part), latching connections or stitched connections also come into question.
[0084] The powder inhaler according to the invention is provided for single use, and therefore the inhaler housing cannot be used again after the powder-receiving hollow has been opened and the dose of powder has been inhaled, and this also serves to protect against misuse. In addition to the good recyclability or the biodegradability, the increased volume of packaging waste, which is considered a drawback from the point of view of environmental protection, is also offset, however, by the reduced use of multidose inhalers, the disposal of which is more complicated since residual quantities of the pulverulent medicament are usually contained therein.
[0085] The single-dose powder inhaler according to the invention permits economical use for various indications, for instance when only a few uses are necessary, or when the inhaler is used only when required. The powder inhaler according to the invention is hygienic, and undesired influences such as high air humidity or soiling on account of misuse are largely ruled out. By virtue of the cost-effective production, the powder inhaler according to the invention is also suitable for use in the Third World and in crisis regions.
[0086] In fact, the powder inhaler according to the invention is so favorable in terms of its production that a patient-specific medicament blister pack can be realized in an economically justifiable manner. The composition and dosing of the pulverulent medicament (or plurality of medicaments) can thus be filled into the powder inhaler according to the invention in a specific manner tailored to each patient.
[0087] The plastic used to produce a powder inhaler according to the invention, designed as a disposable item, can preferably be a biodegradable plastic. Moreover, the plastic can be either a plastic with antiseptic or antibacterial and/or antimicrobial properties or can be provided at least partially with an antiseptic or antibacterial and/or antimicrobial coating. Thus, in particular the air inlet channel, medicament chamber and air outlet channel can be coated in order that no germs are inhaled when using the inhalation device. However, on account of the easier application, it is also possible for the entire inhalation device to be coated. An example of such a coating is Perlazid from Rilit-Lackfabrik GmbH, Endingen, Germany.
[0088] A powder inhaler according to the invention can also be marketed for example in an outer packaging which ensures that the powder inhaler is clean or sterile and thus immediately ready for use. Alternatively, it may also be conceivable for a cover element to be provided at the air inlet opening and the outlet opening, with which cover element the openings can be closed, for example, in the manner of a yogurt pot lid.
[0089] Finally, the plastic used to produce a powder inhaler according to the invention can have a marker for the identification thereof, in order for it to be possible to identify counterfeits that do not contain the marker.
LIST OF REFERENCE CHARACTERS
[0090] 1 housing part with powder capsule [0091] 2 housing part [0092] 3 film element [0093] 30 closure tab [0094] 31 tear-off tab [0095] 4 nosepiece [0096] 6 winding [0097] 7 air channel wall [0098] 8 shell base [0099] 8 ribbing [0100] 9 edge [0101] 10 single-dose powder inhaler [0102] 11 medicament chamber [0103] 11 powder-receiving hollow [0104] 12 outlet opening [0105] 12 widening [0106] 13 outlet channel [0107] 14 air inlet opening [0108] 14 widening [0109] 15 powder-retaining structure [0110] 15 barrier [0111] 16 tab opening [0112] 17 tab channel [0113] 18 inlet channel [0114] 19 mouthpiece [0115] 20 baffle wall [0116] E connecting plane [0117] L.sub.A air outlet flow direction [0118] L.sub.E air inlet flow direction