Delivery System for Metered Dose Inhalers

Abstract

An accessory device for delivering medications from press and breath metered-dose inhalers (pMDIs), 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 press and breath MDI. The mouthpiece contains a reed that functions as an audible signal, and a screen to prevent inhalation of unwanted particles. The adaptor positions the press and breath MDI at an angle to direct the aerosol spray toward the center of the collapsible flexible bag. When the press and breath MDI is triggered, it discharges the aerosolized medication into the center of the collapsible flexible bag which is then inhaled by the user through the mouthpiece. This collapses the bag. The reed emits an audible sound if the user inhales above a pre-determined flow rate to maximize medication delivery and ensure dose-to-dose consistency.

Claims

1. An accessory delivery device for press and breath metered dose inhalers for providing a drug to a user through inhalation, the device comprising: a flexible collapsible airbag having an open top end and a bottom end, the bottom end sealed to prevent the passage of air into or out from the flexible collapsible airbag from the bottom end, a top end cap having a top surface, the top end cap having first and second openings in the top surface, sealing means surrounding the top end cap for providing an airtight seal between the top end cap and the open top of the flexible collapsible airbag, a tubular mouthpiece having a proximal end suitable for the user to place the proximal end in the user's mouth, and a distal end mounted in the first of said openings, the tubular mouthpiece in fluid communication with the flexible collapsible airbag, a filtering screen within the tubular mouthpiece; an air actuated audible sounding mechanism mounted in the tubular mouthpiece for providing an audible signal when a predetermined inhalation flow rate of air passing through the audible sounding mechanism is exceeded, signaling the user to decrease the inhalation flow rate to maximize the utilization of the drug, an upstanding collar in the second of said openings in the top end cap, the upstanding collar being disposed at an angle of between 8 to 18 degrees to the top surface of the top end cap, a press and breath metered dose inhaler adaptor mounted on the collar, the metered dose inhaler adaptor having a centrally disposed flexible member, an opening in the centrally disposed flexible member adapted for receiving a press and breath metered dose inhaler, the press and breath metered dose inhaler dispensing an aerosol spray containing a drug through the press and breath metered dose inhaler adaptor in a direction away from the top end cap and into the flexible collapsible airbag when activated, whereby the user inhales the aerosol spray containing the drug through the mouthpiece and the filtering screen, and the audible sounding mechanism provides an audible signal when inhaling from the flexible collapsible airbag through the mouthpiece exceeds the predetermined inhalation flow rate.

2. The accessory delivery device for press and breath metered dose inhalers of claim 1, and further comprising a flexible sealing member mounted in the centrally disposed flexible member having a slot for receiving the press and breath metered dose inhaler in substantially fluid tight engagement.

3. The accessory delivery device for press and breath metered dose inhalers of claim 1, and further comprising a bottom end cap for sealing the bottom end of the flexible collapsible airbag to the bottom end cap.

4. The accessory delivery device for press and breath metered dose inhalers of claim 3, wherein the top end cap and bottom end cap are manufactured from high density polyethylene.

5. The accessory delivery device for press and breath metered dose inhalers of claim 1, wherein said audible sounding mechanism is a reed that vibrates producing an audible sound when the flow rate of the air from the flexible collapsible airbag exceeds the predetermined inhalation flow rate.

6. The accessory delivery device for press and breath metered dose inhalers of claim 5, wherein said reed produces a whistling sound when the flow rate of the air from the flexible collapsible airbag exceeds the predetermined inhalation flow rate.

7. The accessory delivery device for press and breath metered dose inhalers of claim 4, wherein the flexible collapsible airbag is low density polyethylene.

8. The accessory delivery device of claim 7, wherein the flexible collapsible airbag is metallocene low density polyethylene.

9. The accessory delivery device for press and breath metered dose inhalers of claim 1, wherein the mouthpiece has locking tabs in the distal end and the first of said openings has slots to receive the locking tabs whereby the mouthpiece is removably attached to the first of said openings for ease of installation for use and removal for cleaning.

10. The accessory delivery device for press and breath metered dose inhalers of claim 1, wherein the collar has keyways and the metered dose inhaler adaptor has internal keys that are received in the keyways to align the press and breath metered dose inhaler adaptor with the top end cap so that the opening in the centrally disposed flexible member is aligned to receive the press and breath metered dose inhaler.

11. The accessory delivery device for press and breath metered dose inhalers of claim 1, wherein the flexible collapsible airbag gives the user a visual indication that all of the aerosol spray containing the drug has been inhaled when the collapsible flexible collapsible airbag is substantially collapsed.

12. The accessory delivery device for press and breath metered dose inhalers of claim 1, and further comprising a channel in the press and breath metered dose inhaler adaptor that receives the collar to securely attach the press and breath metered dose inhaler adaptor to the collar.

13. The accessory delivery device for press and breath metered dose inhalers of claim 1, wherein the flexible collapsible airbag has a volume of between 42.11-42.72 cubic inches when in a fully expanded position.

Description

DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 illustrates the prior art of a press and breath MDI showing the drug/propellant containing canister seated in an actuator.

[0015] FIG. 2 is an exploded view of the inventive delivery device for press and breath metered dose inhalers.

[0016] FIG. 3 is a top view of the top end cap of the device with the mouthpiece and adaptor attached.

[0017] FIG. 4 is a top perspective of the top end cap with the adaptor and mouthpiece attached,

[0018] FIG. 5 is a side view of the mouthpiece.

[0019] FIG. 6 is a rear perspective view of the mouthpiece showing the screen component of the mouthpiece.

[0020] FIG. 7 is top view of the reed.

[0021] FIG. 8 is a bottom view of the reed.

[0022] FIG. 9 is a top perspective view of the pMDI adaptor.

[0023] FIG. 10 is a bottom perspective view of the pMDI adaptor.

[0024] FIG. 11 is a cross sectional view of the adaptor taken along lines 11-11 of FIG. 9.

[0025] FIG. 12 is a top perspective view of the top end cap.

[0026] FIG. 13 is cross sectional view taken along line 13-13 of FIG. 12.

[0027] FIG. 14 is a bottom view of the bottom end cap.

[0028] FIG. 15 is a top view of the bottom end cap.

[0029] FIG. 16 is a front perspective view of the collapsible flexible bag.

[0030] FIG. 17 is a front perspective view of the collapsible flexible bag when in a horizontal position.

[0031] FIG. 18 is a front perspective view of the assembled device in the vertical position.

[0032] FIG. 19 is a perspective view of the inventive device in the horizontal position with the press and breath MDI actuator inserted into the adaptor.

[0033] FIG. 20 is a bottom view of the top end cap with the pMDI actuator inserted.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0034] As described above, FIG. 1 illustrates the components of the intact press and breath MDI (pMDI) 10. Turning to FIG. 2, there is illustrated an exploded view of a delivery device 20 for press and breath metered dose inhalers 10. There is a mouthpiece 22, containing a screen 48, that has a reed 24 inserted into a lower end 26 of the mouthpiece 22. The mouthpiece 22 is inserted into a top end cap 28 through opening 30. The opening 30 has two opposite rectangular slots 32 which receive locking tabs 34 at the lower end 26 of the mouthpiece 22 (seen in FIG. 6).

[0035] The top end cap 28 also has an upstanding collar 36 angularly disposed with respect to the top planar surface of the top end cap 28. The top end cap 28 is 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. There are a pair of vertically disposed keyways 38 cut into the wall of the upstanding collar 36. A pMDI adaptor 40 is mounted on the collar 36. There are keys 42 (FIG. 10) that are received in the keyways 38 to properly align the pMDI adaptor 40 with the collar 36 so that the pMDI actuator 13 is properly positioned for use in the pMDI adaptor 40. There is a channel 41 in the pMDI adaptor that receives the collar 36 in tight engagement to firmly, but releasably retain the pMDI adaptor 40 on the collar 36. A collapsible flexible bag 44 is located below the top end cap 28. The collapsible flexible bag 44 is preferably made from a low density metallocene polyethylene (LDPE) However other similar materials exhibiting the same characteristics may also be available. At the bottom of the metallocene LDPE bag 44 is a bottom end cap 46. The top end cap 28 has a circumferential collar that closely receives the top of the metallocene LDPE bag 44. The bottom end cap 46 has a similar circumferential collar that receives the bottom of the metallocene LDPE bag 44. The low density metallocene polyethylene exhibits at least two important characteristics. First it allows the collapsible flexible bag 44 to attach to the top end cap 28 and bottom end cap 46 which are made from high density polyethylene (HDPE). This creates an airtight seal between the top and bottom end caps 28 and 46 and the collapsible flexible bag 44. Second the metallocene LDPE exhibits antibacterial properties. The volume of the collapsible flexible bag 44 when in the expanded position should preferably be between 42.11-42.72 cubic inches (approximately 690-700 cubic cm).

[0036] As seen in FIG. 3, the mouthpiece 22 contains the screen 48 in its central channel. FIGS. 3 and 4 illustrate the mouthpiece 22 and pMDI adaptor 40 mounted on the top end cap. An airtight seal is provided between the mouthpiece 22 and the top end cap 28 and the pMDI adaptor 40 and the upstanding collar 36.

[0037] FIGS. 5 and 6 more clearly illustrate the mouthpiece 22. The locking tabs 34 are clearly illustrated at opposite sides of the bottom of the mouthpiece 22. As seen in FIG. 6, there is an internal collar 50 for the reed attachment that receives and correctly positions the reed 24 within the bottom of the mouthpiece 22. FIGS. 7 and 8 illustrate the reed 24. There are a pair of vibrating members 52 mounted in slots 54. One end of the each of the vibrating members 52 is fixed to the reed body while the opposite end is free to vibrate. Other types of reed designs can be used as is commonly known in the art. The purpose of the reed is to vibrate and produce an audible sound if the air flow past the reed exceeds a preset level.

[0038] FIGS. 9-11 illustrate the pMDI adaptor. The adaptor 40 is preferably made from a flexible material that is sufficiently rigid to retain its shape when inserted onto the collar 36 but has an innermost ring 56 with a centrally disposed slot that is flexible enough to receive various size pMDI actuator exit tubes 18. The pMDI actuator is snugly received in the slot in the innermost ring 56 so that there are no gaps between the innermost ring and the pMDI actuator thus forming a substantially airtight seal between the innermost ring 56 and the pMDI adaptor 40.

[0039] FIG. 12 clearly illustrates the opening 30 with the slots 32 cut in the top end cap 28. These receive the locking tabs 34 in the bottom of the mouthpiece 22. Once the locking tabs 34 are inserted, the mouthpiece is rotated so that the locking tabs 34 firmly lock the mouthpiece to the top end cap 28. The collar 36 is also shown with the keyways 38. These receive the keys 42 in the underside of the pMDI adaptor 40.

[0040] FIG. 13 is a cross sectional view of a portion of the pMDI adaptor 40 mounted to the collar 36 which in turn is mounted to or integrally formed with the top end cap 28. FIGS. 14 and 15 illustrate bottom end cap 14. As seen in FIG. 15 there is an upstanding collar or rim that closely receives in an airtight fitting the bottom of the flexible bag 44.

[0041] FIGS. 16 and 17 illustrate the cylindrical shape of the metallocene LDPE flexible bag 44. FIG. 18 illustrates the assembled delivery device for pMDIs 20. The mouthpiece 22 and pMDI adaptor 40 are fitted onto the top end cap 28. Inside of the mouthpiece 22 are the reed 24 and screen 48. The metallocene LDPE flexible bag 44 is securely fitted to the top end cap 28 and bottom end cap 46.

[0042] FIG. 19 is similar to FIG. 18 except that a pMDI 10 is inserted into the pMDI adaptor 40. As see in FIG. 2, the upstanding collar 36 is angularly disposed at an angle A of between 8 to 18 and preferably 13 with respect to the center line along the axis of the flexible bag 44. The angle is determined by the location of the collar 36 from the perimeter of the end cap 28 so that the spray or plume of medication from the canister is disbursed into the center of the flexible bag 44 when the flexible bag 44 is in the expanded position in a direction toward the center of the bottom end cap 46. This optimizes spray plume distribution within the flexible bag 44 and minimizes the spray hitting the side walls of the flexible bag 44. For example, when the device 20 is held horizontally, and with a diameter of the end cap being 3.085 inches, the distance from the circumference of the end cap 28 to a line extending horizontally from the center of actuator nozzle 16 is between 0.984 inches to 1.22 inches as illustrated in FIG. 20 by the letter B.

[0043] To use the device 20, the mouthpiece 22 is inserted via the locking tabs 34 into slots 32 and rotated to lock the mouthpiece to the top end cap 28. The user inserts the pMDI actuator 13 into the innermost ring 56 so that it is properly aligned with the opening in the innermost ring 56 and the collar 36. The user opens the bag 44 fully. The user then depresses the pMDI canister 11, which then generates an aerosolized plume of medication into the metallocene LDPE bag 44. As the actuator exit tube 18 is properly aligned in the collar 36, it results in the plume 17 being directed toward the center of the metallocene flexible bag 44. The user inhales through mouthpiece 22, generating negative pressure in bag 44 and causing aerosolized medication to flow into the user's respiratory tract, thereby collapsing the metallocene flexible bag 44. The inspiratory flow reed 24 signals if the user inhales above the predetermined flow rate, above 1.0 liter/sec. After inhalation and 10 second breathhold, the user manually opens and expands the bag 44 to allow for a subsequent pMDI actuation cycle. The device 20 provides two indicators if the device is used properly. 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 is 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.

[0044] Thus, there has been provided a delivery assist device for press and breath metered dose inhalers for providing aerosolized drug to a user through inhalation that provides for the receipt of various sized original manufactured, pre-assembled pMDIs. It also provides two indicators for the user to make sure that the full dose of medication is inhaled and that the rate of inhalation is not at a flow rate that exceeds recommended flow rates. While the invention has been described in conjunction with a specific embodiment, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, it in intended to embrace all such alternatives, modifications and variations as fall within the spirit and scope of the claims.