Aerosol delivery apparatus

Abstract

An apparatus and method for performing positive pressure (PP) therapy alone or in combination with an aerosol delivery apparatus. The positive pressure apparatus includes a positive pressure valve having a continuously variable respiratory window. The PP valve may be associated with a patient respiratory system interface alone, such as, but not limited to, a mask or mouthpiece, or in combination with an aerosol delivery apparatus.

Description

700, as shown in FIG. 18, with axially extending vent tubes from internal valves. When the external tube or stem of a pressurized metered dose inhaler canister 700 is depressed it operates the internal valve to dispense a measured dose of medicine from the stem. The medicine is commonly packed in the canister with a suitable compressed gas to propel the medicine and gas from the stem or tube when the later is depressed. The medicine may be in gas, liquid, or solid form. The manufacturer or distributor of the pressurized metered dose inhaler canister generally supplies it with a substantially L-shaped adapter 602 which receives the canister in a substantially upright position, and has a substantial horizontal outlet portion for reception in the mouth of an asthmatic patient for inhalation of the medicine.

In order to address the problem of coordination and other problems known in the art with regard to pressurized metered dose inhalers, a spacer chamber with an integrated actuator, or an aerosol holding chamber, have been used in attempts to overcome inappropriate particle size. The aerosol holding chamber is generally provided at the upstream or entering end with a flexible, resilient adapter or backpiece made of rubber or the like material. A central aperture is provided for receipt of the horizontal outlet portion of the pressurized metered dose inhaler adapter.

One embodiment provides for an improved pressurized metered dose inhaler or pressurized metered dose inhaler with an aerosol holding chamber. As shown in FIG. 37, a PP apparatus 600 may be associated with the pressurized metered dose inhaler or the pressurized metered dose inhaler with an aerosol holding chamber. In the PP apparatus 600 of FIGS. 37-39, an L-shaped adapter portion 602 holds the pressurized canister and a horizontal outlet section 604 receives the medicament released in aerosol form. A one-way valve 606, which may be a flexible membrane, a rigid membrane, hinged door, or other commonly known valve mechanism is positioned at the proximal end 608 of the horizontal outlet section 604. To provide the positive expiratory pressure, the one-way valve 606 permits inhalation and blocks exhalation so that substantially all exhalation is routed through the variable resistance window 610 adjacent the one-way valve 606. A slide control 612 is movable in the resistance window 610 by a tab 614 to close off or open up as much of the resistance window as necessary to provide the desired expiratory pressure. FIGS. 38a and 39a illustrate the slide control in a completely open position and FIGS. 38b and 39b illustrate the slide control closing off the resistance window. The slide control may maintain its position in the resistance window through friction, detents or other known mechanisms for mechanically retaining one of multiple desired positions. The proximal end 608 of the metered dose inhaler 600 with PP functionality may be used by a patient directly or fitted to an adapter on an aerosol chamber such as shown in FIG. 3. FIG. 40 illustrates another embodiment of a pressurized metered does inhaler 620 with a round proximal end 628 that may be used without the need for special mouthpieces or aerosol holding chambers. As with the embodiment of FIGS. 37-39, the alternative PEP enabled pressurized metered dose inhaler 620 has a one-way valve 626 that shunts exhalant through a resistance window 622 that is continuously adjustable with a slide control 624 that can adjust the aperture of the resistance window.

Generally, a mouthpiece or mask may be associated the PP apparatus. In one configuration, an aerosol holding chamber may be attached to the mouthpiece or mask end and a metered dose inhaler may be positioned on a generally opposite end of the chamber via a backpiece. The user of the device may insert the mouthpiece into the mouth to obtain a dose of medicament. Further, the user may place the mask over the mouth and/or nose to inspire a dose of the medicament. In either situation, the mask or mouthpiece aids in the delivery of the medicament to the user.

As has been described, a method and apparatus from providing positive expiration or inhalation therapy, with or without separate aerosol generating devices, has been disclosed. In the embodiment where the positive expiratory pressure valve is located at or near the output end of the aerosol delivery apparatus, a one way inhalation valve can be located further downstream from the positive expiratory pressure valve. A mouthpiece and or mask can be affixed at or near the output end of the aerosol delivery apparatus. The positioning of the inhalation valve either upstream or downstream in respect to the positive expiratory pressure valve is well known to one skilled in the art. Further, it is envisioned that PEP therapy may be performed nasally with the positive expiratory pressure apparatus.

When the mouthpiece having the PP apparatus associated therewith is used alone to perform PEP therapy, and not in conjunction with a mechanism for the delivery of a substance, a one way inhalation valve is engageable with the mouthpiece. The inhalation valve functions so as to allow for inhalation by the patient into the mouthpiece. The exhalant of the patient is prevented from exiting via the inhalation valve and is directed to exit through the PP valve. Generally, an inhalation valve opens upon inhalation to allow a fluid, such as an aerosol, to enter a chamber or channel or the like but that closes upon exhalation to prevent exhaled fluids to enter into the chamber of the like. The drawings depict an exemplary embodiment of the one-way inhalation valve but are not to be limiting to the embodiments shown.

One aspect of the method of use of the PP apparatus can be understood by the following disclosure and reference to FIGS. 1-3, 5 and 9. Particularly, the arrow 2 in FIG. 1 indicates the direction of flow of the exhalant. The one-way valve shunts exhalant out between the mouthpiece and the aerosol chamber via the continuously variable resistance window. In carrying out the method, a physician may initially determine the proper resistance setting of the PP apparatus according to the patient's requirements. One manner in which the PP apparatus may be properly set is by attaching a fitting 39 to the mouthpiece. A manometer is then attached to the fitting port 41 and serves to measure the expiratory pressure. A patient will exhale into the mouthpiece and the pressure can be read from the manometer. The physician can the move the tab to one of the desired settings indicated on the mouthpiece. Once the proper resistance has been determined the fitting 39 can be removed from the mouthpiece. This fitting 39 will not be used again unless it is determined that the resistance should be adjusted.

The method of performing PEP therapy using the PP apparatus includes performing a series of breaths. When exhalation is performed, the exhalant is directed through the continuously variable expiratory window. Performance of a therapeutic cough triggers the loosening of secretions. Upon loosening of the secretions, a medicament may be provided for inhalation into the respiratory system. In one embodiment of PEP therapy, the user will exhale into the mouthpiece and/or mask, against the desired resistance. This is done either prior to or in combination with inhalation of the medicament. The exhaled gases exit through the resistance window. This process may be repeated as many times as prescribed by the patient's physician.

As has been described, a method and apparatus for providing positive expiration, or inhalation, pressure therapy, with or without separate aerosol generating devices, has been disclosed. The aerosol delivery apparatus with the PP apparatus may be used alone or in combination with a mask or mouthpiece. Also, an improved aerosol delivery apparatus with an integrated actuator has been shown, wherein the improvement comprises a PP valve. The discussion above is descriptive, illustrative and exemplary and is not to be taken as limiting the scope defined by any appended claims.

Claims

1. A positive respiratory pressure apparatus comprising:

a patient respiratory system interface;

a one-way valve positionable in the patient respiratory interface and configured to pass a fluid traveling in a predetermined direction from a first side to a second side of the one-way valve; and

wherein the patient respiratory system interface comprises a bypass window integral with, and defined by, the patient respiratory interface, the bypass window positioned adjacent the one-way valve, and wherein the patient respiratory interface further comprises a window opening adjustment mechanism movably disposed in the patient respiratory system interface and operable to change a size of an opening between the patient respiratory system interface and ambient air outside of the patient respiratory system interface, whereby the bypass window and window opening adjustment mechanism cooperate to selectively create one of a plurality of fluid resistances.

2. The apparatus of claim 1, wherein the bypass window and window opening adjustment mechanism are configured to cooperate with the one-way valve to provide an inspiratory pressure at the patient respiratory system interface.

3. The apparatus of claim 1, wherein the bypass window and window opening adjustment mechanism are movable into a plurality of overlapping positions.

4. The apparatus of claim 3, wherein the window opening adjustment mechanism comprises a tapered portion, and wherein the size of the opening is defined by an overlap position of the tapered portion relative to the bypass window.

5. The apparatus of claim 1, wherein an edge of the window opening adjustment mechanism is movable to overlap an edge wall of the bypass window at a non-perpendicular angle.

6. The apparatus of claim 1, wherein the fluid traveling in the predetermined direction comprises inhaled gas and the one-way valve comprises a one-way inhalation valve, and wherein the one-way inhalation valve is configured to cooperate with the bypass window and window opening adjustment mechanism to create a positive expiratory pressure at the patient respiratory system interface.

7. The apparatus of claim 6, wherein the window opening adjustment mechanism is positioned over the bypass window.

8. The apparatus of claim 6, wherein the window opening adjustment mechanism is positioned beneath the bypass window.

9. The apparatus of claim 8, wherein the bypass window comprises an opening in a curved wall formed in the patient respiratory interface, and the window opening adjustment mechanism is movably positioned adjacent the opening in the circular wall.

10. The apparatus of claim 6, wherein the opening defined by the bypass window and window opening adjustment mechanism is continuously adjustable between a first exhalation resistance and a second exhalation resistance.

11. The apparatus of claim 1, wherein the patient respiratory system interface comprises a mouthpiece.

12. The apparatus of claim 1, wherein the patient respiratory system interface comprises a mask.

13. The apparatus of claim 1, wherein the patient respiratory system interface is integrally formed with a metered dose inhaler.

14. The apparatus of claim 13, wherein the patient respiratory system interface defines a circular opening at a proximal end.

15. The apparatus of claim 13, wherein the patient respiratory system interface defines an oblong opening at a proximal end.

16. The apparatus of claim 13, wherein the bypass window is oriented perpendicular to the one-way valve.

17. The apparatus of claim 1, wherein the one-way valve comprises a duck-bill valve.

18. The apparatus of claim 1, wherein the one-way valve comprises an annular valve.

19. The apparatus of claim 1, further comprising an aerosol delivery apparatus in fluid communication with the patient respiratory interface.

20. The apparatus of claim 19, wherein the aerosol delivery apparatus comprises a nebulizer.

21. The apparatus of claim 19, wherein the aerosol delivery apparatus comprises an aerosol holding chamber.

22. A respiratory apparatus comprising:

a holding chamber having an input end and an output end and defining a longitudinal flow axis therebetween, the longitudinal flow axis extending in a longitudinal direction;

a patient respiratory system interface comprising a mouthpiece member and a retainer member, wherein the retainer member is disposed adjacent the output end of the holding chamber and wherein the mouthpiece member comprises an annular wall extending in a longitudinal direction and surrounding the longitudinal flow axis;

an inhalation flow control member positionable in the patient respiratory interface between the mouthpiece member and the retainer member, wherein the inhalation flow control member is self-contained in the patient respiratory system interface and is sealed between the mouthpiece member and the retainer member; and

an exhalation flow control member separate from the inhalation flow control member and moveably coupled to the mouthpiece member of the patient respiratory system interface, wherein the exhalation flow control member extends in the longitudinal direction;

wherein the patient respiratory system interface comprises an expiratory path window integral with, and defined by, the mouthpiece member of the patient respiratory system interface, wherein the expiratory path window is formed in the annular wall of the mouthpiece member, and wherein the exhalation flow control member is moveable between a first position, wherein at least a portion of the expiratory path window is open such that exhaust gases can escape through the expiratory path window during exhalation, and a second position, wherein the exhalation flow control member is positioned over and closes the expiratory path window.

23. The respiratory apparatus of claim 22 wherein the inhalation flow control member comprises a duck-bill valve.

24. The respiratory apparatus of claim 22 wherein the retainer member comprises an annular wall fitting over and mating with an annular shoulder formed on the output end of the holding chamber.

25. The respiratory apparatus of claim 22 wherein the retainer member is releasably coupled to the mouthpiece member.

26. The respiratory apparatus of claim 22 wherein the retainer member is coupled to the mouthpiece member with a snap-fit.

27. The respiratory apparatus of claim 22 wherein the retainer member is coupled to the mouthpiece member with a friction fit.

28. The respiratory apparatus of claim 22 wherein the mouthpiece and retainer members are permanently joined.

29. The respiratory apparatus of claim 22 further comprising an aerosol delivery device containing a medicament coupled to the input end of the holding chamber.

30. The respiratory apparatus of claim 29 wherein the aerosol delivery device comprises a pressurized metered dose inhaler.

31. The respiratory apparatus of claim 22 wherein the annular wall is non-circular.

32. The respiratory apparatus of claim 22 wherein the exhalation flow control member comprises a retaining portion secured to the mouthpiece member.

33. The respiratory apparatus of claim 32 wherein the retaining portion comprises a ridge fitting into a channel formed in the mouthpiece member.

34. The respiratory apparatus of claim 32 wherein the exhalation flow control member extends in the longitudinal direction from said retaining portion toward the input end of the holding chamber.

35. A respiratory apparatus comprising:

a holding chamber having an input end and an output end and defining a longitudinal flow axis therebetween, the longitudinal flow axis extending in a longitudinal direction;

a patient respiratory system interface comprising a mouthpiece member and a retainer member, wherein the retainer member is disposed adjacent the output end of the holding chamber, wherein the mouthpiece member comprises an annular wall extending in a longitudinal direction and surrounding the longitudinal flow axis, and wherein the mouthpiece member comprises a front wall facing the user and extending transverse to the longitudinal direction;

an inhalation flow control member positionable in the patient respiratory interface between the mouthpiece member and the retainer member; and

an exhalation flow control member separate from the inhalation flow control member and moveably coupled to the mouthpiece member of the patient respiratory system interface, wherein the exhalation flow control member extends in the longitudinal direction;

wherein the patient respiratory system interface comprises an expiratory path window integral with, and defined by, the mouthpiece member of the patient, respiratory system interface, wherein the expiratory path window is formed in the annular wall of the mouthpiece member, and wherein the exhalation flow control member is moveable between a first position, wherein at least a portion of the expiratory path window is open such that exhaust gases can escape through the expiratory path window during exhalation, and a second position, wherein the exhalation flow control member is positioned over and closes the expiratory path window, and wherein the exhalation flow control member comprises a portion extending through the front wall of the mouthpiece member so as to be exposed to a user.

36. The respiratory apparatus of claim 28 wherein the mouthpiece and retainer members are bonded.

37. A respiratory apparatus comprising:

a holding chamber having an input end and an output end and defining a longitudinal flow axis therebetween, the longitudinal flow axis extending in a longitudinal direction;

a patient respiratory system interface comprising a mouthpiece member and a retainer member, wherein the retainer member is disposed adjacent to the output end of the holding chamber;

an inhalation flow control member positionable in the patient respiratory interface between the mouthpiece member and the retainer member, wherein the inhalation flow control member is self-contained in the patient respiratory system interface and is sealed between the mouthpiece member and the retainer member, the inhalation flow control member comprising a base portion having a center hole, wherein said base portion remains stationary relative to the longitudinal direction during inhalation; and

an exhalation flow control member separate from the inhalation flow control member and moveably coupled to the mouthpiece member of the patient respiratory system interface, wherein the exhalation flow control member extends in the longitudinal direction:

wherein the patient respiratory system interface comprises an expiratory path window integral with, and defined by, the mouthpiece member of the patient respiratory system interface, wherein said expiratory path window is formed in a wall extending in the longitudinal direction, and wherein the exhalation flow control member is moveable between a first position, wherein at least a portion of the expiratory path window is open such that exhaust gases can escape through the expiratory path window during exhalation, and a second position, wherein the exhalation flow control member is positioned over and closes the expiratory path window.

38. The respiratory apparatus of claim 37 wherein the inhalation flow control member comprises a duck-bill opening downstream of the center hole during inhalation.

39. The respiratory apparatus of claim 37 wherein the retainer member comprises an annular wall fitting over and mating with an annular shoulder formed on the output end of the holding chamber.

40. The respiratory apparatus of claim 37 wherein the retainer member is releasable coupled to the mouthpiece member.

41. The respiratory apparatus of claim 37 wherein the retainer member is coupled to the mouthpiece member with a snap-fit.

42. The respiratory apparatus of claim 37 wherein the retainer member is coupled to the mouthpiece member with a friction fit.

43. The respiratory apparatus of claim 37 wherein the mouthpiece and retainer members are permanently joined.

44. The respiratory apparatus of claim 43 wherein the mouthpiece and retainer members are bonded.

45. The respiratory apparatus of claim 37 further comprising an aerosol delivery device containing a medicament coupled to the input end of the holding chamber.

46. The respiratory apparatus of claim 50 wherein the aerosol delivery device comprises a pressurized metered dose inhaler.

47. The respiratory apparatus of claim 37 wherein the exhalation flow control member comprises a retaining portion secured to the mouthpiece member.

48. The respiratory apparatus of claim 47 wherein the retaining portion comprises a ridge fitting into a channel formed in the mouthpiece member.

49. The respiratory apparatus of claim 47 wherein the exhalation flow control member extends in the longitudinal direction from said retaining portion toward the input end of the holding chamber.

50. A respiratory apparatus comprising:

a holding chamber having an input end and an output end and defining a longitudinal flow axis therebetween, the longitudinal flow axis extending in a longitudinal direction;

a patient respiratory system interface comprising a mouthpiece member and a retainer member, wherein the retainer member is disposed adjacent to the output end of the holding chamber, and wherein wherein the mouthpiece member comprises a front wall facing the user and extending transverse to the longitudinal direction;

an inhalation flow control member positionable in the patient respiratory interface between the mouthpiece member and the retainer member, the inhalation flow control member comprising a base portion having a center hole, wherein said base portion remains stationary relative to the longitudinal direction during inhalation and

an exhalation flow control member separate from the inhalation flow control member and moveably coupled to the mouthpiece member of the patient respiratory system interface, wherein the exhalation flow control member extends in the longitudinal direction;

wherein the patient respiratory system interface comprises an expiratory path window integral with, and defined by, the mouthpiece portion of the patient respiratory system interface, wherein said expiratory path window is formed in a wall extending in the longitudinal direction, and wherein the exhalation flow control member is moveable between a first position, wherein at least a portion of the expiratory path window is open such that exhaust gases can escape through the expiratory path window during exhalation, and a second position, wherein the exhalation flow control member is positioned over and closes the expiratory path window, and wherein the exhalation flow control member comprises a portion extending through the front wall of the mouthpiece member so as to be exposed to a user.