EP2440273A1

EP2440273A1 - Powder inhalation device

Info

Publication number: EP2440273A1
Application number: EP10737963A
Authority: EP
Inventors: Jean-Marc Pardonge
Original assignee: Valois SAS
Current assignee: Aptar France SAS
Priority date: 2009-06-11
Filing date: 2010-06-08
Publication date: 2012-04-18
Also published as: US20120048270A1; FR2946538A1; WO2010142905A1; FR2946538B1

Abstract

The invention relates to a powder inhalation device that comprises a body (10) with a dispensing opening (15), at least one tank containing a powder dose to be dispensed, tank opening means (80) for opening a tank upon each actuation, a dispersion chamber (70) comprising an outlet (720) connected to the dispensing opening (15) and an inlet (710) connected to said tank opening means and receiving the powder dose from said open tank, said dispersion chamber (70) containing at least one mobile member (75), such as a bead, wherein said device comprises moveable means remote from said at least one mobile member (75), the moveable means acting without contact on said at least one mobile member (75) for moving the same in said dispersion chamber (70).

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 in order 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 inhalateu r 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 better tightness of the powder, since each dose is open only 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 placed 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 some 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 changed the dose (either from a multi-dose tank or from an individual tank) and when he inhales, he may lose some or all 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 realizes 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 a 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 orifice. distribution. This dispersion chamber provides good deagglomeration of the powder, and has a positive effect on the flow resistance by decreasing it. However, the beads require some energy to be set in motion, and it is only after this initial phase that they provide their maximum effects. In addition, the action of the inhalation flow on the beads is not homogeneous in the dispersion chamber, generally being greater than the level of the inlet of this chamber relative to the opposite side, so that the ball or balls disposed away from said inlet do not act optimally. The action, and therefore the effectiveness, of the beads is also dependent on the user-created inhalation flow, which can vary greatly from one use to another, and the nature of the powder to be expelled. This creates undesirable variability in expulsion characteristics and performance. Documents EP-2 022 526, US Pat. No. 6,328,033 and US Pat. No. 7,185,648 describe other devices of the state of the art.

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 q ui is simple and inexpensive to manufacture and assemble, reliable use, ensuring dosing accuracy and reproducibility of the dosage at each actuation, providing optimal performance the effectiveness of the treatment, by allowing a large part of the dose to be distributed to the areas to be treated, in particular the lungs, safely and effectively avoiding the risks of overdoses, of as small a size as possible, while guaranteeing a tightness and absolute integrity of all the doses until their expulsion.

Another object of the present invention is to provide such an inhaler which ensures good dosing accuracy and good dose reproducibility at each actuation, irrespective of the orientation of the inhaler and / or independently of the inhalation flow. provided by the user and / or regardless of the nature of the powder to be expelled.

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 actuation, 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 at least one movable element, such as a ball, said device comprising means for displacing said at least one movable element remotely moving said contactless acting means on said at least one movable element so as to move it in motion. adite dispersion chamber, said remote displacement means comprising at least one magnet and / or at least two electrodes and / or at least one coil.

Advantageously, said at least one movable element is made of or coated with a ferromagnetic material.

Advantageously, said remote displacement means comprise at least one magnet, in particular an electromagnet.

Advantageously, said displacement means comprise two arcuate electromagnets arranged around a portion of the periphery of the dispersion chamber.

Advantageously, said displacement means comprise at least two electrodes arranged above and below said dispersion chamber.

Advantageously, said displacement means comprise at least one coil creating a magnetic field, in particular disposed close to said dispersion chamber. Advantageously, said remote displacement means are activated at the moment of inhalation.

Advantageously, the device comprises at least one sensor, such as a flow sensor and / or a pressure sensor, said sensor detecting inhalation and simultaneously activating said remote displacement means.

Advantageously, said flux sensor activates said remote displacement means from the detection of an inhalation flow having at least a threshold flow rate, such as 5 l / min.

Advantageously, said remote displacement means act on I edit at least one movable element to rotate in said dispersion chamber at a speed of at least 3000 rpm, preferably at least 5000 rpm. Advantageously, the movement speed of said at least one movable element in said dispersion chamber is independent of the inhalation flow rate, said remote displacement means providing said at least one moving element with a substantially constant speed. Advantageously, said dispersion chamber contains a plurality of balls, in particular six.

Advantageously, all the balls are of the same dimensions.

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 flow 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:

FIG. 1 is a diagrammatic cross-sectional view of a powder inhaler,

FIG. 2 represents a schematic perspective view of part of the inhalation device of FIG. 1, according to an advantageous embodiment of the invention,

FIG. 3 is a diagrammatic cross-sectional side view of a portion of the inhalation device of FIG. 1, according to another advantageous embodiment of the invention,

FIG. 4 is a view similar to that of FIG. 3, according to yet another advantageous embodiment of the present invention, and FIG. 5 is a servo-control diagram according to an alternative embodiment of the invention. FIG. 1 shows an advantageous variant embodiment of a dry powder inhaler. This hanger 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 includes a mouthpiece or inhalation end defining a dispensing orifice 15 through which the user will inhale during actuation of the device. The covers may open by pivoting for a common axis of rotation, but any other means of opening the device is possible. Alternatively, the device could have 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. Prior to first use, the blister band may be wound within the body 10, preferably in a storage portion, and first tape moving means 30 is provided to progressively unwind and advance. this blister strip. Second displacement means 50, 51 are provided for bringing a respective individual or blister reservoir into a dispensing position each time the device is actuated. The part of tape comprising the empty tanks is advantageously adapted to wind in another location of said body 10, preferably a receiving part. The inhaler comprises reservoir opening means 80 (which are shown 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 solicited, 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 moving 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 operating cycle of the device may be as follows. When the device is opened, the two lateral parts forming a cover are spaced apart from one another and pivoted on the body to open the device, and thus charge 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, 110. Preferably, it is during the inhalation by the user through the mouthpiece that these locking means are unlocked, which then causes the pivoting ment of said support member 50 and thus the displacement of said wheel. indexing 30 towards the needle, and therefore the opening of a reservoir.

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 deformed under the effect of inhalation, this unit being adapted to release the locking means 100, 110, for example v ia 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 locking means and thus to allow the displacement of the second displacement means, and therefore a respective reservoir to its open position. 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 the opening of a respective reservoir 21. This dispersion chamber 70 is provided with at least one movable element 75, preferably made under the shape of a ball. Preferably, there are six balls as shown in FIG. 2. These balls move inside said chamber 70, to improve the distribution of the air and powder mixture after the opening of a reservoir, in order to increase the efficiency 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 cover portion 702 assembled one upon the other at the time of assembling the device. Advantageously, the exit

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 702. The dispersion chamber 70 comprises a ball path 730, which preferably follows the shape of the latter, namely a circle or an ellipse depending on the case. This ball path 730 advantageously comprises a substantially flat bottom surface and two side edge walls curved or curved to allow rapid movement of the balls. This ball path 730 can be defined radially internally by an appropriate profile 740 provided on the cover portion 702, as shown in FIGS. 3 and 4. As a variant, it would be possible to provide a central projection made on the part of bottom 701 facing the exit 720 of the dispersion chamber 70. This would be advantageous especially for the assembly, the balls 75 automatically coming into the ball path 730 before the attachment of the cover portion 702 on the bottom portion 701. Exit 720 preferably has one or more restrictions 725 within the channel to prevent expulsion of ball (s) 75 provided in the dispersion chamber 70. This is a security in the event that a ball 75 had to 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. As seen in FIG. 2, the inlet 710 connects the dispersion chamber 70 to the piercing element 80 via a channel 69. In the variants shown, the balls 75 rotate in one direction, 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 in the opposite direction to the inside the dispersion chamber. Similarly, the entry 710 is not necessarily perfectly tangential, and depending on the case, it could even it would be desirable to provide an input 710 slightly offset from the tangent.

According to the invention, displacement means, acting remotely and without contact with the ball or balls 75, are provided. One objective is to make the displacement, and in particular the rotational speed, of the balls 75 more independent of the flow rate of the flow or the inhalation flow created by the user. Indeed, with each use, the inhalation provided by the user varies. However, it is desirable to have a constant pharmaceutical performance with each use of the inhaler. The invention fulfills this requirement by making the movement of the balls 75 in the dispersion chamber 70 constant at each use, regardless of the flow rate of the inhalation flow. In addition, by removing from the flow of inhalation the task of setting the balls alone (in addition to the actuation of the opening means and the expulsion of the powder towards the dispersion chamber), it increases the operating range of the inhaler, so that it can operate with lower inhalation rates. Moreover, by providing the balls with high rotational speeds, the invention makes it possible to guarantee a constant performance, independently of the powder to be expelled, by smoothing the de-agglomeration performance. By always guaranteeing the same speed of rotation of the balls, regardless of the inhalation flow rate and regardless of the nature of the powder, the invention makes it possible to optimize the reliability of the inhaler. The remote displacement means of the present invention are therefore different from the simple inhalation described for example in document US Pat. No. 6,715,486. Advantageously, the balls 75 are made of or coated with a ferromagnetic material, and the displacement means may include one or more magnets, such as electromagnets. FIG. 2 shows two circular-arc magnets 1001, 1002 arranged around a part of the periphery of the dispersion chamber 70, operating in the manner of a particle accelerator to give the balls 75 their speed of rotation very quickly. maximum rotation. Typically, this speed of rotation can be greater than 4000 revolutions per minute (rpm), preferably at least 5000 rpm.

Alternatively, as shown in FIG. 3, electrodes 1010, 1020, which can be placed respectively above and below the dispersion chamber 70, are used to act on the balls 75. FIG. another variant, with a coil 1100, creating a magnetic field, disposed near the dispersion chamber 70. In all cases, the remote displacement means act without contact on the balls 75 to set them in motion and make them turn in the dispersion chamber 70, through the electromagnetic fields created during their activation. They can be powered by any suitable power source.

Advantageously, these remote displacement means 1001, 1002; 1010, 1020; 1100 are controlled by inhalation, and activated from the beginning of inhalation. Advantageously, provision can be made for this purpose one (or more) flow sensor and / or pressure (not shown), adapted to detect an inhalation flow. This sensor may for example comprise a piezoelectric sensor. This sensor may advantageously be disposed inside the inhaler, for example near the inhalation orifice. From a threshold flow, for example 5 liters per minute (l / min), the sensor activates the displacement means, and the rotation of the balls 75 is very fast. Advantageously, the balls already rotate in the dispersion chamber 70 when the powder arrives, driven by the inhalation flow after opening the blister. Of course, the rotation of the balls 75 can be obtained by the joint action of the remote displacement means and the inhalation flow.

FIG. 5 illustrates a diagram of the slaving of the inhalation flow in an exemplary embodiment. The goal is to manage the inhalation rate of the user, by measuring this flow rate in or near the dispersion chamber, then to compare it to a desired or desired flow rate or threshold, corresponding to optimal performance, and to act according to the measured difference. Q inha lation is the user's inhalation rate. The sensor of flow of the direct chain measures the inhalation flow, the objective being to align this flow rate with the value of the desired flow rate. Ic is an output quantity of the flow sensor (intensity), the latter representing a set inhalation flow rate, which is an optimum flow rate for obtaining good pharmaceutical performance. The comparator will make it possible to control the chain of action composed of an amplification and a flow motor generating a compensation of the missing flow to the user. The amplification will make it possible to amplify the difference between the setpoint flow rate and the actual measured flow rate in order to be able to exploit the information, the is the flow difference to be disturbed by the flow engine. The flow motor represents the remote displacement means whose action generates the inhalation flow rate missing from the user. K is an experimental data, namely a coefficient of proportionality between the speed of the balls and the flow rate in the dispersion chamber (Engine). Q Engine is the flow rate in the dispersion chamber representing the output data that is to be enslaved. The flow sensor of the return chain measures the flow rate in the dispersion chamber (Engine), and Im is the flux measured in the dispersion chamber.

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 individual sealed containers, for example 30 or 60 doses stored on a roll-wound strip;

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 drive means engaged with the blisters to effect the movement of the blister strip at each actuation, and to bring a new reservoir into a position in which it is intended to be opened by the appropriate opening methods;

• An effective and constant dispersion of the powder before its expulsion, to limit the powder retentions and to guarantee a good accuracy and reproducibility of dosage at each actuation, even in case of orientation or optimal inhalation, and independently of inhalation rate and the nature of the powder.

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 different 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 the way in which the individual reservoirs are arranged by compared to 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 the reservoir (80) for opening a reservoir at 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 open reservoir, said dispersion chamber (70) containing at least one movable element (75), such as a ball, characterized in that said device comprises remote displacement means (1001, 1002; 1010, 1020; 1100); said at least one movable member (75), said displacing means acting without contact on said at least one movable member (75) to move it into said dispersing chamber (70), said remote moving means comprising at least one minus a magnet and / or at least oins two electrodes and / or at least one coil.

2.- Device according to claim 1, wherein I edit at least one movable member (75) is made of or coated with a ferromagnetic material.

3.- Device according to claims 1 or 2, wherein said remote displacement means comprise at least one magnet, in particular an electromagnet.

4.- Device according to claim 3, wherein said displacement means comprise two arcuate electromagnets (1001, 1002) disposed around a portion of the periphery of the dispersion chamber (70).

5.- Device according to any one of the preceding claims, wherein said displacement means comprise at least two electrodes (1010, 1020) disposed above and below said dispersion chamber (70).

6. Device according to any one of the preceding claims, wherein said moving means comprise at least one coil (1100) creating a magnetic field, in particular disposed close to said dispersion chamber (70).

7. A device as claimed in any one of the preceding claims, wherein said remote moving means is activated at the time of inhalation.

8.- Device according to claim 7, comprising at least one sensor, such as a flow sensor and / or a pressure sensor, said sensor detecting inhalation and activating simultaneously said remote displacement means.

9.- Device according to claim 7, wherein said flow sensor activates said remote displacement means from the detection of an inhalation flow having at least a threshold flow, such as 5 l / min.

Apparatus according to any one of the preceding claims, wherein said remote displacement means acts on said at least one movable member (75) to rotate in said dispersion chamber (70) at a speed of at 3000 rpm, preferably at least 5000 rpm.

11. Apparatus according to any one of the preceding claims, wherein the speed of movement of said at least one movable element (75) in said dispersion chamber (70) is independent of the inhalation flow, said remote displacement means providing said at least one movable element with a substantially constant velocity.

12. Apparatus according to any one of the preceding claims, wherein said dispersi on 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 said means opening means (80) are piercing means comprising a needle adapted to pierce a reservoir at each actuation.

15.- Device according to any one of claims, wherein said opening means are controlled by the 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).