EP2341965A1

EP2341965A1 - Powder inhalation device

Info

Publication number: EP2341965A1
Application number: EP09794038A
Authority: EP
Inventors: Jean-Marc Pardonge
Original assignee: Valois SAS
Current assignee: Aptar France SAS
Priority date: 2008-07-11
Filing date: 2009-07-10
Publication date: 2011-07-13
Also published as: JP2011527215A; FR2933620B1; FR2933620A1; CN102089028A; US20110120467A1; WO2010004229A1

Abstract

Powder inhalation device comprising a body (10) provided with a dispensing port, at least one reservoir containing a dose of powder to be dispensed, reservoir opening means for opening a reservoir upon each actuation, a dispersion chamber (70) comprising an outlet (720) connected to said dispensing port and an inlet (710) connected to said opening means and receiving the dose of powder from said open reservoir, wherein said dispersion chamber (70) contains at least one moving part (75), such as a ball, said dispersion chamber (70) comprises a peripheral ball track (730) and an air passage (760) separate from and concentric with said ball track (730) and positioned radially outwards therefrom.

Description

Powder inhalation device

The present invention relates to a device for inhalation of powder, and more particularly to a dry powder inhaler.

Inhalers are well known in the state of the art. There are different kinds. A first type of inhaler contains a reservoir receiving a multitude of doses of powder, the inhaler being provided with dosing means allowing each actuation to separate a dose of this powder from the reservoir to bring it into an expulsion conduit to to be distributed to the user. Inhalers with individual reservoirs, such as capsules, which are to be loaded into the inhaler just prior to use thereof have also been described in the state of the art. The advantage of these devices is that it is not necessary to store all the doses inside the device, so that it can be reduced in size. By cons, the use is more complex, since the user is obliged to load a capsule in the inhaler before each use. Another type of inhaler is to package the doses of powder in pre-dosed individual tanks, then to open one of these tanks each actuation of the inhaler. This implementation ensures a better seal of the powder, since each dose is open at the time of its expulsion. To make these individual tanks, various variants have already been proposed, such as an elongated blister strip or blisters arranged on a rotating circular disk. All types of inhalers described above and existing have advantages and disadvantages related to their structure and operation. Thus, with some inhalers, there is the problem of accuracy and reproducibility of the dosage at each actuation. Similarly, the effectiveness of the distribution, that is, the portion of the dose that actually enters the user's lungs to have a beneficial therapeutic effect, is also a problem with a number of inhalers. One solution to this specific problem has been to synchronize the expulsion of the dose with the inhalation of the patient. Again, this could cause drawbacks, that generally in this type of device, the dose is loaded into an expulsion conduit prior to inhalation, and then the expulsion is synchronized with the inhalation. This means that if the user drops, shakes or unwantedly or improperly handles the inhaler between the time he or she changed the dose (either from a multi-dose reservoir or from an individual reservoir) and when inhaling, it may lose all or part of this dose, it may be distributed inside the device. In this case, there may be a high risk of overdose during the next use of the device. The user who will realize that his dose is not complete will charge a new dose into the device, and when inhaling this new dose, part of the previous dose lost in the device could then be expelled at the same time as the new dose, causing an overdose. Depending on the treatments considered, this overdose can be very harmful and it is an increasingly strong requirement of the authorities of all countries to minimize this risk of overdose. Regarding the opening of the individual tanks, it has been proposed to peel or peel off the closure layer. This has the disadvantage of difficult control of the forces to be applied to ensure full opening without the risk of opening the next tank, especially if the opening means must be actuated by inhalation.

To ensure a finely powdered distribution of the powder, US 6,715,486 discloses a dispersion chamber containing one or more balls rotated by the flow of air and powder from the open reservoir to the dispensing orifice. . This dispersion chamber ensures good deamination of the powder, and has a positive effect on the flow resistance by decreasing it. The effects of this ball chamber, however, are relatively sensitive to the orientation of the inhaler at the time of inhalation, with yield, variability or resistance properties that can be affected in case of orientation not optimal, corresponding to the inhaler maintained otherwise than vertically.

The present invention aims to provide a fluid dispenser device, in particular a dry powder inhaler that does not reproduce the aforementioned drawbacks.

In particular, the present invention aims to provide such an inhaler that is simple and inexpensive to manufacture and assemble, reliable in use, ensuring a metering accuracy and reproducibility of the dosage at each actuation, providing optimal performance in the effectiveness of the treatment, allowing to distribute a large part of the dose in the areas to be treated, especially the lungs, safely and effectively avoiding the risks of overdoses, of dimensions as small as possible, while ensuring a seal and absolute integrity of all doses until their expulsion. The present invention also aims to provide such an inhaler which ensures good metering accuracy and good dosing reproducibility at each actuation, regardless of the orientation of the inhaler.

The subject of the present invention is therefore a device for inhaling powder, comprising a body provided with a dispensing orifice, at least one reservoir containing a dose of powder to be dispensed, means for opening a reservoir to open a reservoir for dispensing. each actuating a dispersion chamber having an outlet connected to said dispensing orifice and an inlet connected to said opening means and receiving the dose of powder from said open reservoir, said dispersion chamber containing at least one movable element, such as a ball, said dispersion chamber having a peripheral ball path and an air passage separated from said ball path and disposed radially outwardly thereof.

Advantageously, said ball path is circular or elliptical. Advantageously, said air passage extends along the outer edge of said dispersion chamber. Advantageously, said ball path is separated from said air passage by a peripheral wall.

Advantageously, said peripheral wall extends over part of the height of said dispersion chamber. Advantageously, said peripheral wall is interrupted at the inlet which connects the dispersion chamber to said opening means.

Advantageously, said ball path is defined between said peripheral wall and a central profile, preferably rounded.

Advantageously, said dispersion chamber comprises a bottom portion and a lid portion.

Advantageously, said central profile is formed on the bottom portion, substantially opposite the outlet of the dispersion chamber formed on the lid portion.

Advantageously, the ball path is separated from the air passage by a peripheral wall, a first portion of which is formed on said bottom portion and a second portion is formed on said cover portion.

Advantageously, said inlet is tangential in said dispersion chamber.

Advantageously, said dispersion chamber contains a plurality of balls, in particular six.

Advantageously, all the balls are of the same dimensions.

Advantageously, the width of said ball path is substantially constant by being greater than the diameter of the balls and less than twice said diameter. Advantageously, said opening means are piercing means comprising a needle adapted to pierce a reservoir at each actuation.

Advantageously, said opening means are controlled by inhalation of the user, so that the reservoir is simultaneously opened and emptied, the powder entrained by the inhalation gap passing through said dispersion chamber before being expelled to through the dispensing orifice. These and other features and advantages of the present invention will appear more clearly in the following detailed description, with reference to the accompanying drawings, given by way of non-limiting examples, in which: - Figure 1 is a diagrammatic view of cross section of a powder inhaler,

FIG. 2 is a diagrammatic cross-sectional side view of part of the inhalation device of FIG. 1, according to an advantageous embodiment of the invention, FIG. 3 is a view similar to that of FIG. FIG. 2, in cross section from above, and

FIG. 4 is an exploded perspective schematic of the part of the inhalation device of FIGS. 1 to 3.

In Figure 1 is shown an advantageous embodiment of a dry powder inhaler. This inhaler comprises a body 10 on which can be mounted sliding or pivoting two parts forming a cover (not shown) adapted to be opened to open and load the device. The body 10 may be approximately rounded in shape, but it could have any other suitable shape. The body 10 comprises a mouthpiece or inhalation defining a dispensing orifice 15 through which the user will inhale during the actuation of the device. The covers may open by pivoting about a common axis of rotation, but any other means of opening the device is possible. Alternatively, the device could comprise a single cover instead of two.

Inside the body 10, there is provided a band (not shown) of individual reservoirs, also called blisters, made in the form of an elongated flexible band on which the blisters are arranged one behind the other, in a known manner. Before the first use, the blister strip may be wound inside the body 10, preferably in a storage portion, and first tape moving means 30 are provided to progressively unwind and advance this tape. blister. Second displacement means 50, 51 are provided for bringing a respective individual reservoir or blister into a dispensing position each time the device is actuated. The band portion comprising the empty tanks is advantageously adapted to wind in another location of said body 10, preferably a receiving portion.

The inhaler comprises reservoir opening means 80 (which are indicated in FIG. 1 only very schematically) preferably comprising means for piercing and / or cutting the closure layer of the blisters. For example, the tank opening means advantageously comprise a needle, preferably fixed relative to the body 10, and against which a respective blister is moved at each actuation by the second displacement means. The blister is then pierced by said needle, which penetrates into said blister to expel the powder by means of the inhalation flow of the user. The first moving means are adapted to advance the blister strip before and / or during and / or after each actuation of the device. The second displacement means are adapted to move the reservoir to be emptied against said piercing and / or cutting means during actuation. These second displacement means can be biased, via loading means 800, by an elastic element

510, such as a spring or any other equivalent elastic element, said elastic element being preloadable during opening of the device. Preferably, the first displacement means comprise an indexing wheel 30 which receives and guides the blisters. Rotation of this indexing wheel advances the blister strip. In a particular angular position, a given reservoir is always in position opposite the opening means. The second displacement means may comprise a support member 50 rotatable about an axis of rotation 51, said indexing wheel 30 being rotatably mounted on said support member. An actuation cycle of the device may be the following. When opening the device, the two lateral parts forming the cover are spaced apart from each other by pivoting on the body to open the device, and thus load the device. In this position the indexing wheel can not move towards the needle because the second moving means are retained by appropriate locking means 100, 1 10. Preferably, it is during inhalation by the user through the mouthpiece that these locking means are released, which then causes the pivoting of said support member 50 and thus the displacement of said indexing wheel 30 in the direction of the needle, and thus the opening of a reservoir.

The optimum orientation of the inhaler during use corresponds to a substantially vertical position with the dispensing orifice 15 directed upwards, as shown in FIG.

As explained above, it is desirable that the actuation of the opening means is achieved by inhalation of the user. To effect this triggering by inhalation of the tank opening means, it is possible to provide a triggering system by inhalation, which advantageously comprises a unit 60 that can be moved and / or deformable by inhalation, this unit being adapted releasing the locking means 100, 1 10, for example via a rod 101. This unit advantageously comprises a deformable air chamber 61. The inhalation of the user causes the deformation of said deformable air chamber, thus making it possible to release said blocking means and thus to allow the displacement of the second displacement means, and thus of a respective reservoir towards its position of opening. The reservoir is therefore open only at the moment of inhalation, so that it is simultaneously emptied. There is therefore no risk of loss of dose between the opening of the tank and its emptying. Other means of triggering by inhalation could also be used alternatively, for example by using a pivoting valve which, when the user inhales, pivots under the effect of the depression created by this inhalation, the pivoting of this valve causing the release of the locking means of the movable support means and thus the displacement of the reservoir towards the opening means.

The inhaler further comprises a dispersion chamber 70 which is intended to receive the dose of powder after opening a reservoir respective 21. This dispersion chamber 70 is provided with at least one ball 75, preferably six balls as visible in FIGS. 3 and 4, which move inside said chamber 70 during inhalation, to improve the distribution of the mixture air and powder after opening a tank, in order to increase the effectiveness of the device.

This dispersion chamber 70 is preferably of circular or elliptical shape, with an inlet 710 preferably tangential in said chamber and a perpendicular outlet 720, preferably oriented along a vertical axis passing approximately in the center of said dispersion chamber 70. Preferably , the dispersion chamber 70 is formed of two parts, a bottom portion 701 and a lid portion 702 assembled one upon the other at the time of assembly of the device. Advantageously, the outlet 720 is formed on the cover portion 702, while the inlet 710 is formed by the two parts, namely the bottom portion 701 and the cover portion 702. The dispersion chamber 70 has a path of ball

730, which preferably follows about the shape thereof, namely a circle or an ellipse depending on the case. This ball path 730 advantageously comprises a substantially flat bottom surface and two curved or curved side edge walls. Preferably, this ball path 730 is defined radially inward by a central projection 740, which is preferably made on the bottom portion 701. This is particularly advantageous for the assembly, the balls 75 being automatically placed in the ball path 730 before the attachment of the cover portion 702 to the bottom portion 701. Alternatively, a suitable profile could be provided on the lid portion, as shown in FIG. The central profile 740 is preferably arranged facing the outlet 720 of the dispersion chamber 70, as can be seen in FIG. 2. The outlet 720 preferably has one or more restrictions 725 inside the channel to prevent an expulsion of the or balls 75 provided in the dispersion chamber 70. This is a security in the event that a ball 75 should escape the ball path, for example during assembly. In the preferred embodiment, the dispersion chamber 70 comprises a plurality of balls 75, preferably six, and these beads preferably have the same dimensions. To allow the balls 75 to move rapidly along the ball path 730, this ball path has a width that is greater than the diameter of the balls (or greater than the diameter of the largest ball if the balls have different dimensions). Ball paths 730 can be provided which are sufficiently wide to allow two balls to be arranged side by side in said ball path, but preferably the ball path 730 is designed to allow only one ball to pass through. that time. In this advantageous embodiment, the width of the ball path 730 is therefore less than twice the diameter of the balls. As can be seen in FIGS. 3 and 4, the inlet 710 connects the dispersion chamber 70 to the piercing element 80 via a channel 69. In the variants shown, the balls 75 turn counterclockwise. , but it is understood that the channel 69 which leads to the inlet of the dispersion chamber could be arranged in another orientation with the balls 75 rotating clockwise inside the dispersion chamber . Similarly, the inlet 710 is not necessarily perfectly tangential, and depending on the case, it may even be desirable to provide an inlet 710 slightly offset from the tangent. According to one embodiment of the invention, the ball path 730 is substantially cylindrical and of substantially constant width, and is defined between said central profile 740 and a peripheral wall 750, 751 offset from the radially outer edge of the dispersion chamber 70 , said peripheral wall 750, 751 defining with said outer edge an air passage 760 separated from said ball path 730. Said air passage 760 is disposed radially outside said ball path 730, so that the two flows flow concentrically with respect to each other. In other words, said passage 760 is concentric with said ball path 730, being radially outside said ball path 730. As can be seen in particular in FIG. 2, this peripheral wall extends over a portion from the periphery, and it is preferably interrupted at the inlet 710 of the dispersion chamber 70. Advantageously, the wall 750, 751 extends over more than half a turn starting from the entrance 710, and less than three quarters of a turn, as can be seen in FIGS. 3 and 4. This allows the separated air flows to to mix again before having made a complete turn, which is desirable when the majority of the powder is expelled through the exit 720 before having completed a complete revolution. This separate air passage 760 thus makes it possible to transmit a part of the flow of air that arrives through the inlet 710 in the ball path 730 to rotate the balls 75, and another part of the air flow in said passage 760. This flow of air passing through the separate air passage 760 disposed radially at the outer edge of the dispersion chamber 70 makes it possible to reduce the powder retention on the edge walls of this dispersion chamber 70, in particular in areas remote from entry 710 in the direction of flow. This ensures a better dosing accuracy as well as better dosing reproducibility, even if the inhaler is used in an orientation that is not optimal.

Advantageously, a first transverse wall portion 750 is formed on the bottom portion 701 and a second transverse wall portion 751 is formed on the cover portion 702, as shown in FIG. 2. After inhalation, when the user closes the device, all components return to their initial rest position. The device is then ready for a new cycle of use.

The present invention therefore makes it possible to provide a dry powder inhaler which notably provides the following functions:

A plurality of individual doses of powder stored in sealed individual reservoirs, for example 30 or 60 doses stored on a coil-wound web;

The powder released by means of a piercing actuated by the inhalation of the user, this piercing of the blister being carried out by means of an inhalation detection system coupled to a preloaded release system;

Appropriately shaped training means in engagement with the blisters for moving the blister strip to each actuation, and bring a new reservoir into a position in which it is intended to be opened by the appropriate opening means;

Effective dispersion of the powder prior to expulsion, to limit powder retentions and to ensure good accuracy and reproducibility of dosing at each actuation, even in case of non-optimal orientation of the inhalation.

Other functions are also provided by the device of the invention as previously described. It should be noted that the different functions, even if they were represented as provided simultaneously on the various embodiments of the inhaler, could be implemented separately from each other. In particular, the inhalation triggering mechanism could be used regardless of the type of tank opening means, regardless of the use of a dose indicator, regardless of how individual reservoirs are arranged relative to each other. others, regardless of the shape of the dispersion chamber, etc. The arming means and the trigger system by inhalation could be made differently. It is the same of the other constituent parts of the device.

Various modifications are also possible for a person skilled in the art without departing from the scope of the present invention as defined by the appended claims.

Claims

claims

1 .- Powder inhalation device, comprising a body (10) provided with a dispensing orifice (15), at least one reservoir containing a dose of powder to be dispensed, means for opening a reservoir (80) for opening a reservoir each actuation, a dispersion chamber (70) having an outlet (720) connected to said dispensing orifice (15) and an inlet (710) connected to said opening means and receiving the dose of powder from said reservoir open, said dispersion chamber (70) containing at least one movable element (75), such as a ball, characterized in that said dispersion chamber (70) comprises a peripheral ball path (730), and a passage of air (760) separated and concentric with said ball path (730) and disposed radially outwardly therefrom.

2.- Device according to claim 1, wherein said ball path (730) is circular or elliptical.

3.- Device according to claims 1 or 2, wherein said air passage (760) extends along the outer edge of said dispersion chamber (70).

4. A device according to any one of the preceding claims, wherein said ball path (730) is separated from said air passage (760) by a peripheral wall (750, 751).

5.- Device according to claim 4, wherein said peripheral wall (750, 751) extends over a portion of the height of said dispersion chamber (70).

6.- Device according to claims 4 or 5, wherein said peripheral wall (750, 751) is interrupted at the inlet (710) which connects the dispersion chamber to said opening means.

7.- Device according to any one of claims 4 to

6, wherein said ball path (730) is defined between said peripheral wall (750, 751) and a central profile (740), preferably rounded.

8. A device according to any one of the preceding claims, wherein said dispersion chamber (70) has a bottom portion (701) and a cover portion (702).

9. A device according to claims 7 and 8, wherein said central profile (740) is formed on the bottom portion (701), substantially opposite the outlet (720) of the dispersion chamber (70) formed on the cover portion (702).

10.- Device according to claims 8 or 9, wherein the ball path (730) is separated from the air passage (760) by a peripheral wall, a first portion (750) is formed on said bottom portion ( 701) and a second portion (751) is formed on said cover portion (702).

1 1 .- Device according to any one of the preceding claims, wherein said inlet (710) is tangential in said dispersion chamber (70).

12.- Device according to any one of the preceding claims, wherein said dispersion chamber (70) contains a plurality of balls (75), including six.

13.- Device according to claim 12, wherein all the balls (75) are of the same dimensions.

14.- Device according to any one of the preceding claims, wherein the width of said ball path (730) is substantially constant being greater than the diameter of the balls (75) and less than twice said diameter.

15.- Device according to any one of the preceding claims, wherein said opening means are piercing means comprising a needle adapted to pierce a reservoir at each actuation.

16.- Device according to any one of claims, wherein said opening means are controlled by inhalation of the user, so that the reservoir is simultaneously open and emptied, the powder driven by the flow of inhalation passing through said dispersion chamber (70) before being expelled through the dispensing orifice (15).