Delivery System for Metered Dose Inhalers

Abstract

An accessory device for delivering medications from attached press-and-breathe metered-dose inhalers (MDIs), including those medications containing hydrofluoroalkane propellants. The device includes a collapsible flexible bag to which is attached a bidirectional mouthpiece and an adaptor that receives the MDI. The mouthpiece contains a reed that functions as an audible signal. The adaptor positions the MDI at an angle to direct the aerosol spray toward the center of the bag. When triggered, the MDI discharges the aerosolized medication into the center of the bag, which medication may then be inhaled by the user through the mouthpiece. The user's inhalation causes the bag to collapse. The reed emits an audible sound if the user inhales above a pre-determined flow rate. A cap seals a gap between the adaptor and an attached canister, making the device in combination with the MDI into a closed-bag system.

Claims

1. An accessory delivery device for a press-and-breathe metered dose inhaler (MDI), the MDI having a pressurized canister inserted in an actuator, the device comprising: a flexible collapsible bag having an open top end and a closed bottom end; 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; 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; a warning indicator constructed and adapted to provide an audible signal based on a predetermined inhalation flow rate through the tubular mouthpiece is exceeded; 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; 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 the actuator of the press-and-breathe metered dose inhaler; and a cap constructed and adapted to seal a gap between an inner wall of the actuator and the canister, wherein, 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.

2. The device of claim 1, wherein, when attached to the MDI, the cap prevents air flow through the gap between the inner wall of the actuator and the canister.

3. The device of claim 2, wherein, when attached to the MDI, the cap provides access to a top portion of the canister to allow user activation of the MDI.

4. The device of claim 1, further comprising a tether attached to the cap at a first end of the tether, wherein the tether comprises a ring at a seconds end thereof, said ring connecting said tether to said collar.

5. The device of claim 1, wherein tubular mouthpiece protrudes vertically from the top surface of the top end cap.

6. The device of claim 1, wherein the adaptor is constructed and adapted to fit multiple different sized inhaler actuators.

7. The device of claim 1, wherein the fixed angle is offset from perpendicular to the top surface of the top end cap when the device is in use.

8. The device of claim 1, wherein the first portion of the actuator comprises an actuator exit tube of the actuator.

9. The device of claim 1, and further comprising a flexible sealing member mounted in the centrally disposed flexible member having a slot to receive the press-and-breathe metered dose inhaler in fluid tight engagement.

10. The device of claim 1, and further comprising a bottom end cap sealing the bottom end of the flexible collapsible bag.

11. The device of claim 10, wherein the top end cap and bottom end cap comprise high density polyethylene.

12. The device of claim 1, wherein the warning indicator is mounted in the tubular mouthpiece.

13. The device of claim 1, wherein said warning indicator produces an audible sound when a flow rate of air passing through the tubular mouthpiece exceeds the predetermined inhalation flow rate.

14. The device of claim 13, wherein the warning indicator comprises a reed that vibrates to produce said audible sound when a flow rate of air passing through the tubular mouthpiece exceeds the predetermined inhalation flow rate.

15. The device of claim 13, wherein said warning indicator produces a whistling sound when the flow rate of air passing through the tubular mouthpiece from the flexible collapsible bag exceeds the predetermined inhalation flow rate.

16. The device of claim 1, wherein the flexible collapsible bag comprises low density polyethylene.

17. The device of claim 16, wherein the flexible collapsible bag comprises is metallocene low density polyethylene.

18. The device of claim 1, wherein the flexible collapsible bag provides a visual indication that an appropriate amount of the aerosol spray containing the drug has been inhaled when the flexible collapsible bag is collapsed.

19. The device of claim 1, and further comprising a channel in the press-and-breathe metered dose inhaler adaptor that receives the collar to securely attach the press-and-breathe metered dose inhaler adaptor to the collar.

20. (canceled)

21. The device of claim 1, wherein the fixed angle of the collar to the top surface of the top end cap is between 8 to 18 degrees.

22. The device of claim 1, wherein an airtight seal is provided between the top end cap and the open top end of the flexible collapsible bag.

23. The device of claim 22, wherein the airtight seal is provided by a seal surrounding the top end cap.

24. The device of claim 1, wherein the bottom end of the flexible collapsible bag is sealed to prevent passage of air into or out from the flexible collapsible bag from the bottom end.

25. The device of claim 1, further comprising: a filter within the tubular mouthpiece.

Description

DESCRIPTION OF THE DRAWINGS

[0045] 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:

[0046] FIG. 1 illustrates aspects of a conventional press-and-breathe MDI showing a drug/propellant-containing canister seated in an actuator;

[0047] FIG. 2 depicts aspects of an exploded view of a delivery device according to exemplary embodiments hereof;

[0048] FIGS. 3 and 4 are top and top perspective views, respectively, of a top end cap of a device according to exemplary embodiments hereof, with a mouthpiece and adaptor attached;

[0049] FIG. 5A is a side view of the mouthpiece shown in FIGS. 2-4;

[0050] FIG. 5B is a rear perspective view of the mouthpiece of FIG. 5A showing aspects of a screen component of the mouthpiece;

[0051] FIGS. 6A and 6B are side views of an alternate mouthpiece according to exemplary embodiments hereof;

[0052] FIGS. 7 and 8 are top and bottom views, respectively, of a reed attachment according to exemplary embodiments hereof;

[0053] FIGS. 9 and 10 are top and bottom perspective views, respectively, of an adaptor according to exemplary embodiments hereof;

[0054] FIG. 11 is a cross sectional view of exemplary the adaptor, taken along lines X-X of FIG. 9;

[0055] FIG. 12 is a top perspective view of a top end cap according to exemplary embodiments hereof;

[0056] FIG. 13 is cross-sectional view of the exemplary cap of FIG. 12;

[0057] FIGS. 14 and 15 are bottom and top views, respectively, of a bottom end cap according to exemplary embodiments hereof;

[0058] FIGS. 16 and 17 are front perspective views of a collapsible flexible bag according to exemplary embodiments hereof;

[0059] FIG. 18 is a front perspective view of an assembled device according to exemplary embodiments hereof; and

[0060] FIG. 19 is a perspective view of a device according to exemplary embodiments hereof, with a press-and-breathe MDI actuator inserted into the adaptor;

[0061] FIG. 20 is a bottom view of the top end cap with an MDI actuator inserted;

[0062] FIG. 21 is a front perspective view of an assembled device according to exemplary embodiments hereof, using the mouthpiece of FIGS. 6A-6B;

[0063] FIGS. 22A-22C depict aspects of a cap according to exemplary embodiments hereof;

[0064] FIGS. 23A-23C depict aspects of a tether for a cap according to exemplary embodiments hereof;

[0065] FIGS. 24A and 24B depict aspects of an exemplary delivery device using a tethered cap according to exemplary embodiments hereof; and

[0066] FIGS. 25A-25B shows the exemplary device of FIGS. 24A and 24B in use.

DESCRIPTION OF THE PRESENTLY PREFERRED EXEMPLARY EMBODIMENTS

[0067] FIG. 2 depicts aspects of an exploded view of an exemplary delivery device 120 for press-and-breathe metered dose inhalers (e.g., the MDI 100 of FIG. 1).

[0068] 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 FIG. 5B).

[0069] The mouthpiece 122 may contain a filter in its central channel (e.g., a screen 136, best seen in FIGS. 3 and 6).

[0070] 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.

[0071] The mouthpiece 122 may have a reed attachment 124, described in greater detail below, inserted into a lower end 126 thereof.

[0072] A pair of vertically disposed keyways 140 are cut into the wall of the collar 138. An adaptor 142 (seen also FIGS. 9-11) is mounted on the collar 138. Keys 144 (best seen in FIG. 10) may be received in the keyways 140 to properly align the adaptor 142 with the collar 138 so that the MDI's actuator (e.g., actuator 106 in FIG. 1) is properly positioned for use in the adaptor 142. A channel 145 in the MDI adaptor (best seen in FIG. 11) receives the collar 138 in tight engagement to firmly, but releasably retain the adaptor 142 on the collar 138.

[0073] 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.

[0074] A collapsible flexible bag 146 is located below the top end cap 128.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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).

[0079] FIGS. 3 and 4 illustrate aspects of an exemplary mouthpiece 122 and adaptor 142, according to exemplary embodiments hereof, mounted on the top end cap 128. Airtight seals are preferably provided between the mouthpiece 122 and the top end cap 128 and between the adaptor 142 and the collar 138.

[0080] With reference now to FIGS. 5A and 5B, locking tabs 150 are positioned at opposite sides of the bottom of the mouthpiece 122. As shown in FIG. 5B, the mouthpiece 122 may include an internal collar 152 for a reed attachment, to receive and correctly position the reed attachment 124 within the bottom of the mouthpiece 122.

[0081] FIGS. 6A and 6B are side views of an alternate mouthpiece 122 according to exemplary embodiments hereof. The mouthpiece 122 may connect to the top end cap 128 in the same way as mouthpiece 122, and may have similar internal structure to mouthpiece 122, except that the top end of mouthpiece 122 tapers to an oval shape for easier insertion into a user's mouth.

[0082] As shown, e.g., in FIGS. 7 and 8, a reed attachment 124 according to exemplary embodiments hereof may include a pair of vibrating members 154 mounted in slots 156. One end of the each of the vibrating members 154 is fixed to the reed body while the opposite end is free to vibrate. The purpose of the reed attachment is to produce an audible sound if the inhalation air flow through the mouthpiece exceeds a preset level. Those of skill in the art will understand, upon reading this description, that other mechanisms and/or types of reed designs may be used.

[0083] FIGS. 9-11 illustrate aspects of an adaptor 142 according to exemplary embodiments hereof. The adaptor 142 is preferably made from a flexible material that is sufficiently rigid to retain its shape when inserted onto the collar 138. The adaptor 142 has an innermost ring 158 (seen also in FIG. 13) with a centrally disposed slot that is flexible enough to receive various size MDI actuator exit tubes 116. The MDI actuator is snugly received in the slot in the innermost ring 158 so that there are no gaps between the innermost ring and the MDI actuator thus forming a substantially airtight seal between the innermost ring 158 and the adaptor 142.

[0084] As shown, e.g., in FIGS. 2 and 12, an opening 130 with slots 132 is cut in the top end cap 128. These slots 132 receive the corresponding locking tabs 150 in the bottom of the mouthpiece 122 (and best seen in FIG. 6). Once the locking tabs 150 are inserted through the slots 132, the mouthpiece may be rotated so that the locking tabs 150 firmly lock the mouthpiece to the top end cap 128.

[0085] As also shown, e.g., in FIGS. 2 and 12, the collar 138 has keyways 140 constructed to receive the corresponding keys 144 (seen best in FIG. 10) in the underside of the adaptor 142.

[0086] FIG. 13 is a cross-sectional view of a portion of an exemplary adaptor 142 mounted to a collar 138 which is mounted to or integrally formed with the top end cap 128.

[0087] FIGS. 14 and 15 are bottom and top views, respectively, of a bottom end cap 148 according to exemplary embodiments hereof. As seen, e.g., in FIG. 15, the bottom end cap 148 preferably has is an upstanding collar or rim that closely receives, in an airtight fitting, the bottom of the bag 146.

[0088] FIGS. 16 and 17 illustrate aspects of the cylindrical shape of the bag 146 according to exemplary embodiments hereof, with the bag 146 being shown in the drawings in its fully expand form.

[0089] FIG. 18 illustrates an assembled delivery device 200 according to exemplary embodiments hereof. As shown in the drawing in FIG. 18, the mouthpiece 122 and adaptor 142 are fitted onto the top end cap 128. Inside of the mouthpiece 122, and not visible from the outside, are the reed 124 and screen 136. The bag 146 is securely fitted to the top end cap 128 and bottom end cap 148.

[0090] FIG. 19 shows an exemplary device 200, similar to FIG. 18, with an MDI (e.g., the MDI 100 of FIG. 1) inserted into the adaptor 142.

[0091] As seen in the drawings, e.g., in FIGS. 2, 4, 13, 18, and 19, the collar 138 is angularly disposed at an angle (denoted a) with respect to the center line along the axis of the bag 146. Since the adaptor is inserted into the collar, the adaptor will also be at an offset angle (a) from perpendicular to the top end cap 128. Those of skill in the art will understand, upon reading this description, that configuring the adaptor 142 at an offset angle from perpendicular to the top end cap 128 may improve ease of use of the device and may optimize aerosol delivery into the collapsible bag (See, e.g., the Provisional Application, item 11, pg. 5).

[0092] In some presently preferred implementations, the angle is between 8 to 18, preferably 13.

[0093] The angle 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 FIG. 1) is between 0.984 inches to 1.122 inches as denoted in FIG. 20 by the letter B.

[0094] FIG. 21 is a front perspective view of an assembled device 200 according to exemplary embodiments hereof, using the mouthpiece 122 of FIGS. 6A-6B. The device 200 is shown in the drawing with the flexible bag 146 being partially collapsed.

[0095] A Cap

[0096] 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 FIG. 1, an MDI has a gap (G in FIG. 1) between the canister 102 and the inner wall of the actuator 106. The gap allows air to enter into the actuator body and means that the combination device/MDI does not form a closed-bag system. Furthermore, as also noted above, manufacturers vary the size of the gap from product to product.

[0097] Accordingly, with reference now to FIGS. 22A-22C, embodiments hereof may incorporate a cap 160 sized to fit over the top of an actuator 106 with an installed canister 102. The cap 160 covers the top of the combined actuator/canister, closing or sealing the gap (G) between the canister 102 and the inner wall of the actuator 106. Preferably the cap 160 forms an air-tight seal of the gap (G). The combination of a device 120 with an actuator/canister having cap 160 thereon forms a closed-bag system.

[0098] FIG. 22A shows a cap 160 and an actuator/canister combination, and FIG. 22B shows the cap 160 installed or positioned on the actuator/canister combination.

[0099] As shown best in FIG. 22C, the cap 160 may have a hole 162 in the top thereof to aid in a user triggering the inhaler. However, the hole 162 preferably does not allow air to enter the system once the cap is installed or positioned on the actuator/canister combination. The cap is shown in the drawings as being circular in shape. However, those of skill in the art will understand, upon reading this description, that the cap may be any shape, including rectangular or some other polygonal shape, as long as it fits on an actuator/canister combination and closes or seals the gap between the canister and the inner wall of the actuator.

[0100] The cap 160 may have an outer ridge portion 164 to aid in removal of the cap from the actuator/canister combination.

[0101] 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 FIGS. 23A-23C, embodiments hereof may incorporate a flexible tether 166 having a cap 160 on one end thereof and a ring 168 on the other end. The ring 168 may be sized to fit between the collar 138 and the adaptor 142, with the ring being held in place by the adaptor 142 (as shown, e.g., in FIG. 24A). The cap 160 is sized to fit over the actuator/canister combination an MDI as described above (e.g., MDI 100 as shown in FIG. 24B).

[0102] 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.

[0103] Using the Device

[0104] To use the device 120 with a particular MDI (e.g., MDI 100 shown in FIG. 1) the mouthpiece 122 is inserted via the locking tabs 150 into slots 132 and rotated to lock the mouthpiece to the top end cap 128. The actuator 106 is inserted into the innermost ring 158 so that it is properly aligned with the opening in the innermost ring 158 and the collar 138. The user fully opens the bag 146 and then depresses the canister 102, 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.

[0105] 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.

[0106] 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).

[0107] 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.

[0108] Usage with a Cap

[0109] To use the device 120 with a cap 160 and with a particular MDI (e.g., MDI 100 as shown in FIG. 1) the mouthpiece 122 is inserted via the locking tabs 150 into slots 132 and rotated to lock the mouthpiece to the top end cap 128. The actuator 106 is inserted into the innermost ring 158 so that it is properly aligned with the opening in the innermost ring 158 and the collar 138.

[0110] The cap 160 is positioned over the end of the actuator 106 and the associated canister 102, as shown in FIGS. 22B and 24B.

[0111] 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.

[0112] 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.

[0113] 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).

[0114] 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.

[0115] FIGS. 25A and 25B show the exemplary device of FIGS. 24A and 24B in use, where FIG. 25A shows the device in expanded mode (e.g., prior to the user's inhalation), and FIG. 25B shows the device closed (e.g., at or near the end of the user's inhalation).

[0116] 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.

[0117] 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.

[0118] The exemplary device provides two indicators for the user to ensure proper usagethat 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).

CONCLUSION

[0119] 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.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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).

[0126] 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.

[0127] 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.

[0128] 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.