The present invention relates to a powder inhaler device, and more particularly to a dry-powder inhaler.
Inhalers are well known in the prior art. Various types exist. A first type of inhaler contains a reservoir receiving many doses of powder, the inhaler being provided with metering means making it possible, on each actuation, to remove one dose of said powder from the reservoir, so as to bring said dose into an expulsion duct in order to be dispensed to the user. Inhalers including individual reservoirs, such as capsules, that are loaded into the inhaler just before said reservoir is used are also described in the prior art. The advantage of such devices is that it is not necessary to store all of the doses inside the appliance, such that said appliance can be compact. However, the inhaler is more difficult to use, since the user is obliged to load a capsule into the inhaler before each use. Another type of inhaler consists in packaging the doses of powder in individual predosed reservoirs, then in opening one of the reservoirs each time the inhaler is actuated. That implementation seals the powder more effectively since each dose is opened only when it is about to be expelled. In order to make such individual reservoirs, various techniques have already been proposed, such as an elongate blister strip or blisters disposed on a rotary circular disk. All existing types of inhalers, including those described above, present both advantages and drawbacks associated with their structures and with their types of operation. Thus, with certain inhalers, there is the problem of metering accuracy and reproducibility on each actuation. In addition, the effectiveness of the dispensing, i.e. the fraction of the dose that effectively penetrates into the user's lungs in order to have a beneficial therapeutic effect, is also a problem that exists with a certain number of inhalers. A solution for solving that specific problem has been to synchronize the expulsion of the dose with the inhalation of the patient. Once again, that can create drawbacks, in particular in that type of device, the dose is generally loaded into an expulsion duct before inhalation, then expulsion is synchronized with inhalation. That means that if the user drops, shakes, or manipulates the inhaler in an undesirable or inappropriate manner between the moment when the user loads the dose (either from a multidose reservoir or from an individual reservoir) and the moment when the user inhales, then the user risks losing all or part of the dose, with said dose possibly being spread about inside the appliance. In that event, there can exist a high risk of overdosing the next time the device is used. The user who realizes that the dose is not complete will load a new dose into the appliance, and while the new dose is being inhaled, a fraction of the previous dose that was lost in the appliance could thus be expelled at the same time as the new dose, thereby causing an overdose. In the treatments envisaged, such overdosing can be very harmful, and the authorities in all countries are issuing ever-stricter requirements to limit the risk of overdosing as much as possible. With regard to opening the individual reservoirs, it has been proposed to peel off or to unstick the closure layer. That presents the drawback of difficulty in controlling the forces to be applied in order to guarantee complete opening, without running the risk of opening the next reservoir, particularly if the opening means need to be actuated by inhalation.
In order to dispense the powder in a finely pulverized form, document U.S. Pat. No. 6,715,486 describes a dispersion chamber containing one or more balls that are driven in rotation by the flow of air and powder directed from the open reservoir towards the dispenser orifice. The dispersion chamber breaks up clumps of the powder in satisfactory manner, and has a positive effect on flow resistance by reducing it. However, the balls require a certain amount of energy in order to set them into motion, and it is only after this initial stage that they produce their maximum effect. In addition, the action of the inhalation flow on the balls is not uniform throughout the dispersion chamber, generally being greater at the inlet of the chamber compared with the opposite end, such that the ball(s) located remote from said inlet do not act in optimum manner. The action, and thus the effectiveness, of the balls also depends on the kind of powder to be expelled, and on the inhalation flow created by the user that may vary greatly from one use to another. This creates undesirable variability in the expulsion characteristics and performances.
Documents U.S. Pat. No. 5,577,497, U.S. Pat. No. 7,185,648, WO 01/51112, WO 2007/132441, and FR 2 881 118 describe prior-art devices.
An object of the present invention is to provide a fluid dispenser device, in particular a dry-powder inhaler, that does not have the above-mentioned drawbacks.
In particular, an object of the present invention is to provide such an inhaler that is simple and inexpensive to manufacture and to assemble, that is reliable in use, guaranteeing metering accuracy and metering reproducibility on each actuation, providing an optimum yield with regard to the effectiveness of the treatment, by making it possible to dispense a substantial fraction of the dose to the zones to be treated, in particular the lungs, avoiding, in safe and effective manner, any risk of overdosing, and that is as compact as possible, while guaranteeing sealing and absolute integrity of all of the doses up to their expulsion.
Another object of the present invention is to provide such an inhaler that guarantees good metering accuracy and good metering reproducibility on each actuation, regardless of the orientation of the inhaler and/or regardless of the inhalation flow created by the user and/or regardless of the kind of powder to be expelled.
The present invention thus provides a powder inhaler device comprising: a body provided with a dispenser orifice; at least one reservoir containing a dose of powder to be dispensed; reservoir opening means for opening a reservoir on each actuation; a dispersion chamber including an outlet that is connected to said dispenser orifice, and an inlet that is connected to said reservoir opening means and that receives the dose of powder from said open reservoir, said dispersion chamber containing at least one movable element, said at least one movable element including at least one peripheral hollow sleeve on which at least one projecting element is fastened.
Advantageously, said movable element includes a central sleeve that is mounted on a central rotary shaft.
Advantageously, said at least one projecting element extends in radial projection relative to said central sleeve.
Advantageously, said movable element includes an intermediate sleeve that is coaxial with said central sleeve and that is connected thereto by first radial spacers, said at least one projecting element extending in radial projection relative to said intermediate sleeve.
Advantageously, said at least one projecting element is a ball.
Advantageously, said at least one ball is disposed at the outer radial end of radial spacers that extend radially from said central sleeve and/or from said intermediate sleeve.
Advantageously, said at least one ball is disposed on an outer sleeve that is coaxial with said central sleeve and that is connected thereto via first and/or second radial spacers.
In a variant, said at least one projecting element is a curved branch.
Advantageously, said at least one curved branch extends in curved manner away from said central sleeve.
Advantageously, said movable element includes an intermediate sleeve that is coaxial with said central sleeve and that is connected thereto by first radial spacers, said at least one curved branch extending in curved manner from said intermediate sleeve.
Advantageously, said at least one movable element is connected to drive means, the activation of said drive means causing said at least one movable element to move in said dispersion chamber.
Advantageously, said at least one movable element includes a central sleeve that is mounted on a rotary shaft of said drive means.
Advantageously, said drive means are activated on inhalation.
Advantageously, the device includes at least one sensor, such as a flow sensor and/or a pressure sensor, said sensor detecting inhalation and simultaneously activating said drive means.
Advantageously, said sensor activates said drive means starting from the detection of an inhalation flow having at least one threshold rate, such as 5 liters per minute (L/min).
Advantageously, said drive means cause said movable element to turn in said dispersion chamber at a speed of at least 3000 revolutions per minute (rpm), preferably of at least 5000 rpm.
Advantageously, the speed of movement of said at least one movable element in said dispersion chamber is independent of the inhalation rate, said drive means imparting to said at least one movable element, a speed that is substantially constant.
Advantageously, said drive means comprise a motor.
Advantageously, said drive means include a resilient element, such as a pre-primed or pre-stressed spring.
Advantageously, said movable element includes a plurality of projecting elements that are distributed over the periphery.
Advantageously, said movable element includes six balls, with all of the balls being of the same shape and size.
Advantageously, said movable element includes four curved branches, with all of the curved branches being of the same shape and size.
Advantageously, said at least one movable element includes a plurality of projecting elements that are made in the form of balls, said balls being interconnected via a peripheral outer sleeve.
Advantageously, said opening means are perforator means comprising a needle that is adapted to perforate a reservoir on each actuation.
Advantageously, said opening means are controlled by the user inhaling, such that the reservoir is opened and emptied simultaneously, the powder driven by the inhalation flow passing through said dispersion chamber before being expelled through the dispenser orifice.
These characteristics and advantages and others of the present invention appear more clearly from the following detailed description, given by way of non-limiting example, and with reference to the accompanying drawings, and in which:
Inside the body 10 there is provided a strip (not shown) of individual reservoirs, also known as blisters, said strip being made in the form of a flexible elongate strip on which the blisters are disposed one behind another, in manner known per se. Before first use, the blister strip can be rolled-up inside the body 10, preferably in a storage portion, and first displacement means for displacing the strip 30 are provided for progressively unrolling the blister strip and for causing it to advance. Second displacement means 50, 51 are provided for bringing a respective blister or individual reservoir into a dispensing position each time the device is actuated. The strip portion including the empty reservoirs is advantageously adapted to be rolled-up at another location of said body 10, preferably a reception portion.
The inhaler includes reservoir opening means 80 (that are shown only in very diagrammatic manner in
The first displacement means are adapted to cause the blister strip to advance before and/or during and/or after each actuation of the device. The second displacement means are adapted to displace the reservoir to be emptied against said perforator and/or cutter means during actuation. The second displacement means can be urged, via stressing means 800, by a resilient element 510, such as a spring or any other equivalent resilient element, said resilient element being suitable for being pre-stressed while the device is being opened. The first displacement means preferably comprise an indexer wheel 30 that receives and guides the blisters. Turning the indexer wheel causes the blister strip to advance. In a particular angular position, a given reservoir is always in a position facing the opening means. The second displacement means can include a rotary support element 50 that turns about an axis of rotation 51, said indexer wheel 30 being rotatably mounted on said support element.
An actuation cycle of the device can be as follows. While the device is being opened, the two cap-forming lateral portions are moved apart by pivoting on the body in order to open the device and thus pre-stress the device. In this position, the indexer wheel cannot be displaced towards the needle, since the second displacement means are held by appropriate blocking means 100, 110. Preferably, it is while the user is inhaling through the mouthpiece that the blocking means are unblocked, thereby causing said support element 50 to pivot and thus said indexer wheel 30 to move towards the needle, and thereby causing a reservoir to be opened.
As explained above, it is desirable for the opening means to be actuated by the user inhaling. In order to trigger the reservoir opening means by inhalation, an inhalation trigger system can be provided that advantageously comprises a unit 60 that is displaceable and/or deformable under the effect of inhalation, the unit being adapted to release the blocking means 100, 110, e.g. via a rod 101. The unit advantageously comprises a deformable air-chamber 61. Inhalation by the user causes said deformable air-chamber to deform, thereby making it possible to release said blocking means and to enable the displacement of the second displacement means, and therefore of a respective reservoir towards its opening position. The reservoir is therefore opened only on inhalation, such that it is emptied simultaneously. Thus, there is no risk of any of the dose being lost between opening the reservoir and emptying it.
In a variant, other inhalation trigger means could also be used, e.g. using a pivotable valve flap that, while the user is inhaling, pivots under the effect of the suction created by the inhalation, with pivoting of the valve flap causing the blocking means blocking the movable support means to be released, thereby causing the reservoir to be displaced towards the opening means.
The inhaler further includes a dispersion chamber 70 for receiving the dose of powder after a respective reservoir 21 has been opened. The dispersion chamber 70 is provided with at least one movable element 75, preferably a single movable element, as shown in
The dispersion chamber 70 is preferably circular or elliptical in shape, with an inlet 710 that is preferably tangential in said chamber, and an outlet 720 that is perpendicular, preferably oriented along a vertical axis that passes approximately through the center of said dispersion chamber 70. Preferably, the dispersion chamber 70 is formed of two portions, a base portion 701 and a cover portion 702 that are assembled together during assembly of the device. Advantageously, the outlet 720 is formed on the cover portion 702, while the inlet 710 is formed by both portions, namely the base portion 701 and the cover portion 702. As visible in
In the invention, said at least one movable element 75 includes at least one peripheral hollow sleeve on which at least one projecting element is fastened.
Thus, in the embodiments shown in the figures, which show the preferred embodiments of the invention, the movable element 75 includes a central sleeve 755 that advantageously co-operates with drive means, such as a motor 1000. Nevertheless, the present invention also applies to a movable element that is rotated merely by the user inhaling. In this configuration, the movable element 75 need not include a central sleeve. For example, it could include a plurality of balls, e.g. six, that are interconnected merely via an outer sleeve. The balls are thus fastened relative to one another, thereby guaranteeing uniform and identical rotation of the balls, regardless of their position in the dispersion chamber.
Preferably however, drive means are provided so as to act on, and turn, said at least one movable element 75. An aim is to make the movement, and in particular the speed of rotation, of the movable element 75 more independent of the flow rate or of the inhalation flow created by the user. On each use, the inhalation created by the user varies. However, it is desirable to have consistency in pharmaceutical performance on each use of the inhaler. The invention makes it possible to satisfy this requirement by making the movement of the movable element 75 in the dispersion chamber 70 constant on each use, regardless of the rate of the inhalation flow. In addition, by sparing the inhalation flow from acting on its own to perform the task of setting the movable element(s) into motion (in addition to actuating the opening means and to expelling the powder to the dispersion chamber), the operating range of the inhaler is increased, with said inhaler thus being able to operate with lower inhalation rates. In addition, by imparting a high speed of rotation to the movable element, the invention makes it possible to guarantee consistency of performance, independently of the powder to be expelled, by smoothing its powder break-up performance. By always guaranteeing the same speed of rotation, independently of the inhalation rate, and independently of the kind of powder, the invention makes it possible to optimize the reliability of the inhaler.
Typically, the maximum speed of rotation of the movable element 75 may be greater than 4000 rpm, advantageously at least 5000 rpm, and the maximum speed may be reached very quickly on activating the drive means.
Preferably, the drive means comprise a motor. This variant is described more fully below. In a variant, the drive means could also comprise resilient means, e.g. a leaf spring, which means are pre-stressed or pre-primed, e.g. while the device is being opened, and transmit an appropriate speed of rotation to said at least one movable element 75 on being activated.
Advantageously, the motor 1000 includes a rotary shaft 1005 that is rotated while the motor is activated, and the movable element 75 includes a central sleeve 755 that is assembled on said rotary shaft 1005 so as to be driven by said shaft. From the central sleeve 755, at least one projecting element extends radially outwards. Preferably, a plurality of projecting elements are distributed around said central sleeve 755. In particular, the projecting elements may be formed of balls 751 or of curved branches 759, as described in greater detail below.
The motor 1000 may be powered by any appropriate power source.
Advantageously, the motor 1000 is controlled by inhalation and is activated from the start of inhalation. Advantageously, for this purpose, it is possible to provide one (or more) flow and/or pressure sensor(s) 2000, visible in
After inhalation, when the user closes the device, all of the components return to their initial, rest position. The device is thus ready for a new utilization cycle.
The present invention therefore makes it possible to provide a dry-powder inhaler that performs the following functions:
Other functions are also provided by the device of the invention as described above. It should be observed that the various functions, even if they are shown as being provided simultaneously on the various embodiments of the inhaler, could be implemented separately. In particular, the inhalation trigger mechanism could be used regardless of the type of reservoir opening means, regardless of the use of a dose indicator, regardless of the way in which the individual reservoirs are arranged relative to one another, regardless of the shape of the dispersion chamber, etc. The cocking means and the inhalation trigger system could be made in some other way. The same applies for other component parts of the device.
Various modifications may also be envisaged by a person skilled in the art, without going beyond the ambit of the present invention, as defined by the accompanying claims.
Number | Date | Country | Kind |
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09 53860 | Jun 2009 | FR | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/FR2010/051125 | 6/8/2010 | WO | 00 | 11/4/2011 |