The present disclosure relates to metered-dose inhalers, and more particularly to dilution spacers for use with metered-dose inhalers.
A metered-dose inhaler (MDI) is a device that delivers a measured quantity of aerosolized medication.
Referring now to
Inhaling directly from a metered-dose inhaler can be difficult, and patients may use a tube having a mouthpiece at one end and a receptacle that receives the actuator mouthpiece 116 at the other end. These tubes, referred to as holding chambers or spacers, function as a reservoir to contain the metered dose inhaler plume 120, making it easier to inhale. However, such holding chambers or spacers are generally large and cumbersome.
In one aspect, a dilution spacer for a metered-dose inhaler comprises an enclosure defining a dilution chamber, an actuator inlet configured to securely releasably interengage a metered-dose inhaler actuator mouthpiece, an ambient air inlet and an outlet. Each of the actuator inlet, the ambient air inlet and the outlet are in fluid communication with the dilution chamber. The ambient air inlet is positioned opposite the outlet whereby suction through the outlet from outside the enclosure draws ambient air into the enclosure through the ambient air inlet to generate an airflow path from the ambient air inlet through the dilution chamber and out of the outlet. The actuator inlet is positioned relative to the ambient air inlet and the outlet so that a metered-dose inhaler plume entering the dilution chamber through the actuator inlet intersects the airflow path thereto, whereby airflow along the airflow path entrains and redirects at least a portion of the metered-dose inhaler plume toward the outlet.
The dilution spacer may be incorporated into an assembly further comprising a metered-dose inhaler actuator whose actuator mouthpiece is securely releasably interengaged in the actuator inlet. The actuator mouthpiece may, for example, be friction fit in the actuator inlet or be interference fit in the actuator inlet.
The assembly may further comprise a metered-dose inhaler canister received in the body of the metered-dose inhaler actuator, and the valve stem of the metering valve sealed to the metered-dose inhaler canister may be received by the actuator nozzle of the metered-dose inhaler actuator. The actuator nozzle is configured to generate a metered-dose inhaler plume from contents of the metered-dose inhaler canister and direct the metered-dose inhaler plume into the dilution chamber through the actuator mouthpiece and the actuator inlet. In certain preferred embodiments, the actuator nozzle is configured to direct the metered-dose inhaler plume at an oblique angle to the valve stem.
In some embodiments, the enclosure is generally parallelepipedic, the actuator mouthpiece of the metered-dose inhaler actuator is at an oblique angle to the body of the metered-dose inhaler actuator and the body of the metered-dose inhaler actuator is substantially flush with an edge of the enclosure in which the actuator inlet is formed.
In certain preferred embodiments, the metered-dose inhaler plume entering the dilution chamber through the actuator inlet intersects the airflow path non-parallel thereto, and in certain particular embodiments, the airflow redirects at least a portion of the metered-dose inhaler plume by about 103.5 degrees.
In some embodiments, the outlet comprises a dilution spacer mouthpiece projecting outwardly from the enclosure.
In another aspect, a metered-dose inhaler actuator comprises an enclosure defining a dilution chamber, a receptacle having an actuator nozzle and configured to receive a metered-dose inhaler canister so that the valve stem of the metering valve sealed to the metered-dose inhaler canister is received by the actuator nozzle, and further comprises an ambient air inlet and an outlet. Each of the actuator nozzle, the ambient air inlet and the outlet are in fluid communication with the dilution chamber. The ambient air inlet is positioned opposite the outlet whereby suction through the outlet from outside the enclosure draws ambient air into the enclosure through the ambient air inlet to generate an airflow path from the ambient air inlet through the dilution chamber and out of the outlet. The actuator nozzle is configured to generate a metered-dose inhaler plume from contents of the metered-dose inhaler canister and direct the metered-dose inhaler plume into the dilution chamber. The actuator nozzle is positioned relative to the ambient air inlet and the outlet so that the metered-dose inhaler plume intersects the airflow path, whereby airflow along the airflow path entrains and redirects at least a portion of the metered-dose inhaler plume toward the outlet.
In some embodiments, the outlet comprises a mouthpiece projecting outwardly from the enclosure.
The metered-dose inhaler actuator may be incorporated into an assembly further comprising a metered-dose inhaler canister received within the receptacle with the valve stem of the metering valve of the metered-dose inhaler canister received by the actuator nozzle. In certain preferred embodiments, the actuator nozzle is configured to direct the metered-dose inhaler plume at an oblique angle to the valve stem.
In certain preferred embodiments, the metered-dose inhaler plume entering the dilution chamber through the actuator inlet intersects the airflow path non-parallel thereto, and in certain particular embodiments, the airflow redirects at least a portion of the metered-dose inhaler plume by about 103.5 degrees.
These and other features will become more apparent from the following description in which reference is made to the appended drawings wherein:
Reference is now made to
An actuator inlet 242 is formed through one of the edge walls 238, and is in fluid communication with the dilution chamber 234. The actuator inlet 242 is configured to securely releasably interengage an actuator mouthpiece 116, as shown in
An ambient air inlet 248 is formed through one of the end walls 236 and an outlet 250 is formed through the other one of the end walls 236 and positioned opposite the ambient air inlet. In the illustrated embodiment, the outlet 250 comprises a dilution spacer mouthpiece 252 projecting outwardly from the respective end wall 236 and hence outwardly from the enclosure 232; in alternate embodiments the dilution spacer mouthpiece may have a wide range of different shapes or may be omitted and the outlet may consist of a simple aperture through the respective end wall. The ambient air inlet 248 and the outlet 250 are in fluid communication with the dilution chamber 234.
Reference is now made to
Operation of the assembly comprising the dilution spacer 230 and metered-dose inhaler 100 will now be described with reference to
While inhaling, the user would push the canister 102 toward the actuator nozzle 118 so as to move the valve stem 112 (relative to the canister 102) into the dispensing position and release the metered quantity of medication 108 into the actuator nozzle 118 to generate the plume 120, as shown in
The extremely fast aerosol plume 120 from the actuator nozzle 118 has adequate distance to disperse and develop before it then encounters a fast air jet of comparable velocity, namely the airflow along the fast airflow path FAP. This competitive air speed efficiently entrains the aerosol particles 126 that are small enough to penetrate deeply into the lungs, leaving only large particles (which would have ended up in the user's throat with unaided MDI use) to impact the edge wall 238 opposite the actuator nozzle 118. However, because the fast airflow path FAP is narrow and makes up a minority of the volume of the dilution chamber 234, the volumetric flow rate is low. This has the advantage of prolonging and slowing the inhalation cycle and extending the time over which the aerosol particles are delivered. More particularly, because some of the air drawn into the enclosure 232 bleeds off of the fast airflow path FAP and recirculates in the air recirculation zone ARZ with small aerosol particles 126 entrained therein, the effective inhalation cycle is prolonged. As a user continues to inhale after completion of the discharge from the actuator nozzle 118, he or she can continue to inhale dispersed medication as the medicated air from the air recirculation zone ARZ rejoins the fast airflow path FAP. The relative dimensions of the dilution chamber 234 and the position and orientation of the fast airflow path FAP between the ambient air inlet 248 and the outlet 250 facilitates high velocity flow to effectively entrain small aerosol particles 126, but low volumetric flow rate. This is of particular importance for the effective administration of aerosol medication, because it significantly reduces the impact of the timing of MDI actuation relative to the inhalation cycle. As long as MDI actuation occurs after commencement of inhalation and during the early part of a long and slow deep inhalation, the aerosol particles 126 recirculate until depleted or until the user has fully expanded their lungs and cannot further inhale. An additional benefit is that a given dose of aerosol medication is dispersed within a larger volume of inhaled air (as compared to direct inhalation from the MDI or from a conventional holding chamber or spacer), which can increase tolerability of the medication.
Reference is now made to
The metered-dose inhaler actuator 1130 comprises an enclosure 1132 formed by a pair of opposed outwardly curved end walls 1136, a pair of opposed generally planar edge walls 1138 and a pair of opposed generally planar side walls 1140. While the illustrative enclosure 1132 is generally parallelepipedic, it may have other suitable shapes as well. The enclosure 1132 defines a dilution chamber 1134.
An ambient air inlet 1148 is formed through one of the end walls 1136 and an outlet 1150 is formed through the other one of the end walls 1136 opposite the ambient air inlet. The ambient air inlet 1148 and the outlet 1150 are in fluid communication with the dilution chamber 1134. In the illustrated embodiment, the outlet 1150 comprises an outwardly projecting dilution mouthpiece 1152; in other embodiments the mouthpiece may have different shapes or be omitted entirely.
The metered-dose inhaler actuator 1130 further comprises a receptacle 1160 having an actuator nozzle 1118 and configured to securely releasably receive a metered-dose inhaler canister 102 so that a valve stem 112 of a metering valve 104 sealed to the canister 102 is received by the actuator nozzle 1118, as shown in
The actuator nozzle 1118 is configured to generate a plume 120 (
Operation of the metered-dose inhaler actuator 1130 shown in
Without being limited by theory, and without promising any particular utility, it is believed that the technology disclosed herein enables a slowing of the ordinarily high inhalation air volumetric flow rate with coincident slowing, dispersion and entrainment of the medication in the plume 120, reducing the timing sensitivity of actuation of the metering valve 104. Instead of having to time inhalation and actuation to be substantially coincident (to achieve inhalation instead of having the medication impact the inside of the mouth or settle inside of a conventional holding chamber or spacer), the user can begin a slow, deep inhalation and then actuate the metering valve 104 while continuing to inhale. Thus, again without being limited by theory, and without promising any particular utility, it is believed that the technology disclosed herein enables a more prolonged inhalation cycle, which facilitates deep lung penetration of the medication while reducing oropharyngeal deposition and dose losses by impaction on the holding chamber or spacer walls, all while maintaining a compact and discreet overall geometry. In the illustrated embodiment, the desired geometry is achieved by turning the aerosol plume 120 by entrainment to flow substantially parallel to the longitudinal axis of the canister 102. Thus, in the illustrated embodiments, the plume 120 entering the dilution chamber 234, 1134 intersects the fast airflow path FAP non-parallel (and also non-perpendicular) thereto and the airflow along the fast airflow path FAP redirects at least a portion of the metered-dose inhaler plume 120 by about 103.5 degrees. In this context, the direction of the plume 120 is defined by a notional centroid line of the plume.
While the illustrated embodiments redirect (at least part of) the plume 120 by about 103.5 degrees, redirection by smaller or larger angles, up to 180 degrees, is also contemplated. In the case of a redirection by 180 degrees (i.e. a reversal of direction), the airflow would surround and move past the canister, but in the opposite direction from that of the plume. In each case, the airflow generated by inhalation is not flowing in the same direction as the plume leaving the actuator nozzle, and in a preferred embodiments the airflow is substantially parallel to the longitudinal axis of the canister.
Certain illustrative embodiments have been described by way of example. It will be apparent to persons skilled in the art that a number of variations and modifications can be made without departing from the scope of the invention as defined in the claims.
Filing Document | Filing Date | Country | Kind |
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PCT/CA2018/050814 | 7/4/2018 | WO |
Publishing Document | Publishing Date | Country | Kind |
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WO2019/006547 | 1/10/2019 | WO | A |
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Number | Date | Country | |
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20200222643 A1 | Jul 2020 | US |
Number | Date | Country | |
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Parent | 15644641 | Jul 2017 | US |
Child | 16628972 | US |