Patent Application
20200261669
This invention relates to systems for delivering aerosolized medication from metered-dose inhalers.
Delivery of pharmaceuticals via inhalation has long been considered the standard of care for the treatment patients with acute and chronic respiratory diseases such as asthma and chronic obstructive pulmonary disease (“COPD”). Press-and-breathe metered-dose inhalers (“MDIs”) have become the mainstay of inhaled treatment for such patients and are widely known and used by the medical profession. Experience clearly shows that while widely prescribed, many patients cannot or will not use MDIs as intended.
Suboptimal MDI inhalation techniques contribute to poor lung deposition of medication, poor disease control, adverse asthma and COPD outcomes, and increased medical costs. Studies demonstrate the inability of both patients and healthcare providers to use MDIs properly or effectively.
A number of devices (so-called “spacers”) have been proposed to assist in MDI use. In laboratory test conditions, many Spacers have appeared to improve MDI aerosol delivery to the lower airways; however, outside of the laboratory, experience demonstrates that many patients cannot consistently use these spacers as intended. A major factor contributing to the lack of MDI spacer user consistency is that device users cannot determine if they have consistently both (1) fully inhaled the complete dose following MDI actuation, and (2) inhaled at a sufficiently low inspiratory flow rate necessary for effective delivery of aerosolized medication from MDIs.
Once a MDI canister is triggered, the most important patient-centered factors that relate to optimal lung delivery of medication are: (1) initiation of inhalation prior to 80% of total lung capacity (within approximately the first 1-2 seconds after medication is aerosolized), and (2) that the user generates a sufficiently low inspiratory flow rate to effectively deliver proper sized optimal aerosol particles into the lung alveoli. The subjective terms “long” or “slowly” are common instructions by manufacturers on MDI medication inserts, but these terms have been of little value in ensuring proper patient inhalation technique. Spacer and MDI devices which lack an effective inspiratory flow signal or fail to provide effective visual and auditory feedback regarding complete dose inhalation may result in medication dosing that is not constant dose-to-dose or patient-to-patient.
To aid in this discussion, a conventional pressurized press-and-breathe MDI is described with reference to
In order to deliver a correct, accurate, and consistent drug doses, manufacturers carefully match canisters, metering valve stems (part of the canister) with actuators. For example, after chlorofluorocarbons (“CFCs”) were banned, the change in propellants (to hydrofluoroalkanes (“HFAs”)) required design of new pressurized press-and-breathe MDI medication canisters, metering valve stems, and actuators.
As should be appreciated, an MDI medication canister is distinct from the actuator within which it is mounted. However, separating MDI medication canisters from the actuators with which they were specifically matched will lead to inconsistent and arbitrary doses. Systems that separate a medication canister from its actuator are not capable of ensuring dose accuracy per puff or puff-to-puff dose equivalency. This is one reason the U.S. Food and Drug Administration (FDA) considers each pressurized MDI drug canister and associated actuator device as a unique “combination product,” where each such product is subject to individual approval and regulation.
There is a gap (denoted G) between the inside walls of the actuator 106 and the canister 102. During operation of the MDI, air enters the gap (G) and may mix with the dispensed drug substance/propellant 104. Different MDI drug canister and actuator combinations may have different gap sizes, and may thus have different amounts of external air that may mix with the dispensed drug substance/propellant 104.
It is therefore desirable and an object hereof to provide a delivery system for metered dose inhalers that works with an MDI device without separating the drug canister and its associated actuator device.
It is desirable and an object hereof to provide a device to be used with intact, originally manufactured press-and-breathe MDI combination products to assist in the proper delivery of aerosolized medication from those products.
The present invention is specified in the claims as well as in the below description. Preferred embodiments are particularly specified in the dependent claims and the description of various embodiments.
One general aspect includes an accessory delivery device for press-and-breathe metered dose inhalers. The device may also include a flexible collapsible bag having an open top end and a closed bottom end. The device may also include a top end cap having a top surface, and having a first opening and a second opening in the top surface, the top end cap being connected to the open top end of the flexible collapsible bag. The device may also include a tubular mouthpiece having a proximal end suitable to place in a user's mouth, and a distal end mounted in the first opening of said top surface, the tubular mouthpiece in fluid communication with the flexible collapsible bag. The device may also include a warning indicator constructed and adapted to provide an audible signal based on a predetermined inhalation flow rate through the tubular mouthpiece is exceeded. The device may also include an upstanding collar in the second opening in the top end cap, the upstanding collar being disposed at a fixed angle offset from perpendicular to the top surface of the top end cap. The device may also include an adaptor mounted on the upstanding collar, the adaptor having a centrally disposed flexible member, an opening in the centrally disposed flexible member adapted to receive a first portion of an actuator of a press-and-breathe metered dose inhaler. The device may also include a cap constructed and adapted to seal a gap between an inner wall of the actuator and a canister inserted in the actuator. The device may also include where, when activated, the press-and-breathe metered dose inhaler dispenses an aerosol spray containing a drug through the adaptor in a direction away from the top end cap and into the flexible collapsible bag.
Implementations may include one or more of the following features, alone and/or in combination(s):
Thus, in some aspects, I describe a device to be used with intact, originally manufactured press-and-breathe MDI combination products to assist in the proper delivery of aerosolized medication from MDIs.
Embodiments hereof provide a simple, efficient, easy to use device for patients to consistently deliver containing medications from MDIs. Embodiments ensure consistent puff-to-puff delivery of inhaled medications via an adaptor optimized for MDI medications, and an effective inspiratory flow signal.
The above features along with additional details of the invention are described further in the examples herein, which are intended to further illustrate the invention but are not intended to limit its scope in any way.
Various other objects, features and attendant advantages of the present invention will become fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the several views, and wherein:
A mouthpiece 122 is inserted into a top end cap 128 through an opening 130. The opening 130 may have two opposite rectangular slots 132 to receive corresponding locking tabs 134 at the lower end 126 of the mouthpiece 122 (seen in
The mouthpiece 122 may contain a filter in its central channel (e.g., a screen 136, best seen in
The top end cap 128 has an upstanding collar 138 angularly disposed with respect to the top planar surface of the top end cap 128. The collar 138 may be formed separately from the top end cap 128 and then attached thereto, or the collar 138 and cap 128 may be integrally formed.
The mouthpiece 122 may have a reed attachment 124, described in greater detail below, inserted into a lower end 126 thereof.
A pair of vertically disposed keyways 140 are cut into the wall of the collar 138. An adaptor 142 (seen also
The top end cap 128 is preferably made from high density polyethylene (HDPE) and is substantially flat except for the perimeter that may have an upstanding or tapered edge or other surface imperfections due to the plastic molding process.
A collapsible flexible bag 146 is located below the top end cap 128.
At the bottom of the bag 146 is a bottom end cap 148. The top end cap 128 has a circumferential collar that closely receives the top of the bag 146, and the bottom end cap 148 has a similar circumferential collar that receives the bottom of the bag 146.
The bag 146 is preferably made from a low density metallocene polyethylene (“LDPE”). However other similar materials exhibiting the same characteristics may also be used.
The low density metallocene polyethylene exhibits at least two important characteristics. First it allows the bag 146 to attach to the top end cap 128 and bottom end cap 148 which are made from high density polyethylene (“HDPE”). This creates an airtight seal between the top and bottom end caps 128 and 148 and the bag 146. Second the metallocene LDPE exhibits antibacterial properties.
In a presently preferred implementation, the volume of the bag 146, when in the expanded position, should preferably be approximately 690-700 cubic cm. (i.e., between 42.11 and 42.72 cubic inches).
With reference now to
As shown, e.g., in
As shown, e.g., in
As also shown, e.g., in
As seen in the drawings, e.g., in
In some presently preferred implementations, the angle α is between 8° to 18°, preferably 13°.
The angle α may be determined by the location of the collar 138 from the perimeter of the end cap 128 so that the spray or plume of medication from the canister is disbursed into the center of the bag 146 when the bag 146 is in the expanded position in a direction toward the center of the bottom end cap 148. This optimizes spray plume distribution within the bag 146 and minimizes the spray hitting the side walls of the bag 146. For example, when the device 200 is held horizontally, and with a diameter of the end cap being 3.085 inches, the distance from the circumference of the end cap to a line extending horizontally from the center of actuator nozzle 112 (see
A Cap
In order to control the amount of medication dispensed, it is preferable and desirable for the device 120 in combination with a particular MDI to form a closed-bag system. However, as noted above, with reference to
Accordingly, with reference now to
As shown best in
The cap 160 may have an outer ridge portion 164 to aid in removal of the cap from the actuator/canister combination.
Since the cap 160 is generally to be used in combination with the device 120, the cap may be tethered to the device. For example, and with reference now to
The tether 166 may be made with any suitable flexible material, preferably a material that is safe for skin contact. In a presently preferred exemplary implementation, the tether 166 is made from a viscoelastic PU self-skinning molded foam (at about 3 pounds per cubic foot) and is about 3 mm thick.
Using the Device
To use the device 120 with a particular MDI (e.g., MDI 100 shown in
The user then inhales through mouthpiece 122, generating negative pressure in the bag 146 and causing the aerosolized medication to flow via the mouthpiece 122 into the user's respiratory tract, thereby also collapsing the bag 146.
As the user inhales through mouthpiece 122, the vibrating members 154 of the flow reed attachment 124 signal if the user inhales above a predetermined flow rate (e.g., above 1.0 liter/sec).
After inhalation and a 10 second breath hold, the user manually opens and expands the bag 146 to allow for a subsequent MDI actuation cycle.
Usage with a Cap
To use the device 120 with a cap 160 and with a particular MDI (e.g., MDI 100 as shown in
The cap 160 is positioned over the end of the actuator 106 and the associated canister 102, as shown in
The user fully opens the bag 146 and then depresses the canister 102 through the hole 162 in the top of the cap 160, which then generates an aerosolized plume of medication into the bag 146. With the actuator exit tube 116 properly aligned in the collar 138, the plume 114 is directed into the bag 146, preferably toward the center of the bag 146.
The user then inhales through mouthpiece 122, generating negative pressure in the bag 146 and causing the aerosolized medication to flow via the mouthpiece 122 into the user's respiratory tract, thereby also collapsing the bag 146.
As the user inhales through mouthpiece 122, the vibrating members 154 of the flow reed attachment 124 signal if the user inhales above a predetermined flow rate (e.g., above 1.0 liter/sec).
After inhalation and a 10 second breath hold, the user manually opens and expands the bag 146 to allow for a subsequent MDI actuation cycle.
The device 120 provides two indicators or signals of proper usage. The first signal is a visual signal that indicates whether the user has fully inhaled the medication. This is indicated by the user seeing that the bag is fully collapsed. The second indicator is an audio signal indicating if the user incorrectly inhaled the medication. This signal would be indicated by the reed in the device emitting a whistling or other audible sound if user inhales too fast for proper medication delivery to the lungs.
Thus is provided a delivery assist device for press-and-breathe metered dose inhalers for providing aerosolized drug to a user through inhalation that provides for the receipt of various sized original manufactured, pre-assembled MDIs.
The exemplary device provides two indicators for the user to ensure proper usage—that a full dose of medication is inhaled and that the rate of inhalation is not too fast (i.e., that the inhalation rate does not exceed a recommended flow rate).
As used herein, including in the claims, the phrase “using” means “using at least,” and is not exclusive. Thus, e.g., the phrase “using X” means “using at least X.” Unless specifically stated by use of the word “only,” the phrase “using X” does not mean “using only X.”
In general, as used herein, including in the claims, unless the word “only” is specifically used in a phrase, it should not be read into that phrase.
It should be appreciated that the words “first” and “second” in the description and claims are used to distinguish or identify, and not to show a serial or numerical limitation. Similarly, the use of letter or numerical labels (such as “(a)”, “(b)”, and the like) are used to help distinguish and/or identify, and not to show any serial or numerical limitation or ordering.
As used herein, including in the claims, singular forms of terms are to be construed as also including the plural form and vice versa, unless the context indicates otherwise. Thus, it should be noted that as used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
Throughout the description and claims, the terms “comprise”, “including”, “having”, and “contain” and their variations should be understood as meaning “including but not limited to”, and are not intended to exclude other components unless specifically so stated.
It will be appreciated that variations to the embodiments of the invention can be made while still falling within the scope of the invention. Alternative features serving the same, equivalent, or similar purpose can replace features disclosed in the specification, unless stated otherwise. Thus, unless stated otherwise, each feature disclosed represents one example of a generic series of equivalent or similar features.
The present invention also covers the exact terms, features, values, and ranges, etc. in case these terms, features, values, and ranges etc. are used in conjunction with terms such as “about,” “around,” “generally,” “substantially,” “essentially,” “at least,” etc. (i.e., “about 3” shall also cover exactly 3 or “substantially constant” shall also cover exactly constant).
As used herein, including in the claims, the phrase “based on” means “based in part on” or “based, at least in part, on,” and is not exclusive. Thus, e.g., the phrase “based on factor X” means “based in part on factor X” or “based, at least in part, on factor X.” Unless specifically stated by use of the word “only”, the phrase “based on X” does not mean “based only on X.”
Use of exemplary language, such as “for instance”, “such as”, “for example” (“e.g.,”) and the like, is merely intended to better illustrate the invention and does not indicate a limitation on the scope of the invention unless specifically so claimed.
While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.
This application is a continuation-in-part (CIP) of U.S. application Ser. No. 16/528,957, filed Aug. 1, 2019, which is a CIP of U.S. application Ser. No. 15/057,907 filed Mar. 1, 2016, which is based on and claims the priority of U.S. provisional patent application Ser. No. 62/126,973 filed Mar. 2, 2015 (“the Provisional Application”), the entire contents of each of which are hereby fully incorporated herein by reference for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 62126973 | Mar 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16528957 | Aug 2019 | US |
| Child | 16799631 | US | |
| Parent | 15057907 | Mar 2016 | US |
| Child | 16528957 | US |
