USRE43174E1 - Aerosol delivery apparatus - Google Patents

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

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No. 09/833,019, filed Apr. 11, 2001, now U.S. Pat. No. 6,557,549, which claims the benefit of U.S. Provisional Application No. 60/196,555, filed Apr. 11, 2000, wherein the entirety of each of the aforementioned applications are incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to an apparatus and method for performing Positive Expiratory Pressure (PEP) therapy. More particularly, this invention relates to a method and apparatus for performing PEP therapy alone or in conjunction with an aerosol delivery apparatus.

BACKGROUND

PEP therapy is used primarily in pulmonary secretion removal. Devices used to perform PEP therapy provide positive pressure during expiration. The patient or user exhales against a fixed orifice resistor and generates a pressure ranging approximately from 10-20 cm H₂O. The resistance orifice is an important consideration and frequently is initially set by a physician, veterinarian, or a skilled practitioner in the art. An orifice that is too large may result in a short exhalation that will not produce proper expiratory pressure. An orifice that is too small may result in a longer expiratory phase that raises the pressure above approximately 20 cm H₂O and ultimately increases the work of breathing.

During the exhalation phase of PEP therapy, the airway is splinted open by the pressure. This causes the movement of secretions from the peripheral airways into the larger airways where they can be expelled. PEP therapy usually lasts for about 10-20 minutes and is performed as required, generally 1-4 times per day. Typically, the patient performs 10-20 PEP breaths, removes the device from their mouth and follows this with a forceful exhalation. This final exhalation triggers a cough that loosens secretions.

Studies indicate that PEP therapy dilates the airways and improves the distribution of ventilation, resulting in a better deposition of an inhaled substance, such as, but not limited to, a medicine or remedy. As used herein, the term “aerosol delivery apparatus” means any apparatus capable of producing and/or delivering a substance, such as, but not limited to, a medicine, in a form suitable for inhalation by a patient and includes, without limitation, an aerosol holding chamber, nebulizer, spacer with integrated actuator, a dry powder inhaler, and a metered dose inhaler.

SUMMARY OF THE INVENTION

One aspect of the present invention is directed to a positive respiratory pressure apparatus including a patient respiratory system interface and a valve assembly in fluid communication with the patient respiratory system interface. The valve assembly has a valve configured to pass a fluid traveling in a predetermined direction from a first side to a second side of the valve, and a variable resistance bypass window positioned adjacent the valve and having a resistance to a fluid traveling in a direction opposed to the predetermined direction, where the variable resistance bypass window is continuously adjustable between a first fluid resistance and a second fluid resistance.

According to another aspect of the invention an apparatus is disclosed that is capable of performing positive expiratory pressure (PEP) therapy alone or in combination with providing a substance, generally in aerosol form. The apparatus includes a positive pressure (PP) valve having a continuously variable respiratory window. As used herein, the term respiratory is intended to encompass both inhalation and exhalation. Whether inhalation resistance or exhalation resistance is called for will be known to one skilled in the art. The valve may be located at or near the output end of an aerosol delivery apparatus. U.S. application Ser. No. 08/938,686 filed Sep. 26, 1997 in the name of Engelbreth et al. and Ser. No. 09/287,997 filed on Apr. 7, 1999 in the name of Schmidt et al. describe exemplary embodiments of an aerosol delivery apparatus and the disclosures of these references are incorporated herein by reference. Further, U.S. Pat. No. 4,470,412 to Nowacki et al., describing a spacer or expansion chamber, is additionally incorporated herein by reference. The aerosol delivery apparatus with the PP apparatus may be used alone or in combination with a mask or mouthpiece.

In one embodiment, the PP apparatus is associated with a mask. The mask with the PP apparatus may be used alone or in combination with an aerosol delivery apparatus. In another embodiment, the PP apparatus is associated with a mouthpiece. The mouthpiece with the PP apparatus may be used alone or in combination with an aerosol delivery apparatus. In a further embodiment, the PP apparatus is associated with a nebulizer. The nebulizer with the PP apparatus may be used alone or in combination with a patient respiratory system interface, such as a mask or mouthpiece. In yet another embodiment, the PP apparatus is associated with a spacer chamber with an integrated actuator. The spacer chamber with the integrated actuator associated with the PP apparatus may be used alone or in combination with a mouthpiece or mask.

In another embodiment, a pressurized metered dose inhaler canister is capable of association with an aerosol holding chamber having a PP valve associated therewith. In yet a further embodiment, a pressurized metered dose inhaler canister is capable of association with an aerosol holding chamber engageable with a mouthpiece or mask having a PP valve associated therewith.

Another aspect of the invention is directed to a kit for performing positive expiratory pressure including an aerosol delivery apparatus, a mouthpiece and/or mask attachable to the output end of the aerosol delivery apparatus, and a PP apparatus. The PP apparatus may be located on the aerosol delivery apparatus or the mouthpiece and/or mask. In alter- native embodiments, the PP apparatus may be attached to the aerosol delivery apparatus or integrally formed with the apparatus. The aerosol delivery apparatus, mouthpiece, and PP valve can be combined so as to accomplish positive expiratory therapy and administration of a substance, such as, but not limited to, a medicine in aerosol form. Any aerosol delivery apparatus may be used. In further embodiments of the kit, a backpiece is included for association with an aerosol delivery apparatus. A pressurized metered dose inhaler can engage with the backpiece for delivery of a medicament.

One embodiment of a method of performing positive expiratory pressure therapy includes providing a PP apparatus with a valve that is capable of providing a continuously variable expiratory window. The method further 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 substance, such as a medicament, may be provided for inhalation into the respiratory system. In an alternative embodiment of method, the PP valve may be positioned so as to provide positive inspiratory pressure upon inhalation into the apparatus.

A further aspect of another embodiment includes association of a PP apparatus associable with a mask or mouthpiece engageable with a backpiece device. The backpiece device includes a plastic or an elastomeric adapter suited to receive the mouthpiece of a pressurized metered dose inhaler.

One embodiment of a method of performing positive expiratory pressure therapy includes providing a positive expiratory pressure apparatus having a valve capable of providing a continuously variable resistance window, performing a series of breaths including inhalation and exhalation; exhaling so that the exhalant is directed through the continuously variable resistance window, performing a therapeutic cough triggering the loosening of secretions, and providing an inhaleable medicament.

Another embodiment of a method of performing positive expiratory pressure therapy includes providing a positive respiratory pressure apparatus having a valve capable of providing a continuously adjustable resistance to exhalation, where the valve is located in a mouthpiece attachable to a chamber. A patient then executes a series of therapeutic breaths, including inhalation and exhalation, wherein the exhalant is directed through the continuously adjustable resistance window, the patient performs a therapeutic cough triggering the loosening of secretions, and medicament is provided via the chamber.

According to another aspect of the invention, a method of performing positive expiratory pressure therapy in combination with providing an aerosolized medicament includes providing a positive expiratory pressure apparatus having a positive expiratory pressure valve capable of providing a continuously variable resistance window, where the valve is positionable in a mouthpiece and the mouthpiece attachable to an aerosol holding chamber. A series of therapeutic breaths, including inhalation and exhalation, are then taken where the exhalant is directed through the continuously variable resistance window. The continuously variable resistance window is preferably capable of providing a variable back pressure to the exhalant. A therapeutic cough capable of triggering the loosening of sections is performed and aerosolized medicament from the aerosol holding chamber is administered through inhalation.

One embodiment of an apparatus capable of performing positive respiratory pressure therapy in combination with providing an aerosolized medicament includes a positive respiratory pressure valve having a continuously variable resistance window; and an aerosol holding chamber having an output end, the positive respiratory pressure valve locatable at the output end.

Another embodiment of an apparatus capable of performing positive respiratory pressure therapy includes a positive respiratory pressure valve having a slide control, the slide control providing a continuously variable resistance window; and a mouthpiece, the mouthpiece having a first and a second end, the second end capable of association with the positive respiratory pressure valve.

Yet another embodiment of an apparatus capable of performing positive respiratory pressure therapy in combination with providing an aerosolized medicament includes a positive respiratory pressure valve having a continuously variable resistance window; an aerosol holding chamber having an input end and an output end, the positive respiratory pressure valve locatable at the output end; and a metered dose inhaler canister capable of association with the input end of the aerosol holding chamber.

A still further embodiment of a kit for performing positive expiratory pressure includes an aerosol holding chamber having an inlet and an outlet. A backpiece is attachable to the inlet of the aerosol holding chamber with a metered dose inhaler capable of association with the backpiece. A mouthpiece is attachable to the outlet of the aerosol holding chamber. A positive expiratory pressure valve is generally locatable at the outlet end of the aerosol holding chamber, wherein the aerosol holding chamber, backpiece, mouthpiece, and positive expiratory pressure valve can be combined so as to accomplish positive expiratory therapy and administration of an aerosolized medicament.

An additional embodiment of an apparatus capable of performing positive expiratory pressure therapy in combination with providing an aerosolized medicament includes a positive expiratory pressure valve having a continuously variable resistance window, a mouthpiece, the positive expiratory pressure valve associable with the mouthpiece, and a nebulizer having an input end and an output end, the positive expiratory pressure valve associable with the output end.

Further embodiments include a mouthpiece wherein the improvement comprises a positive pressure valve. An additional embodiment includes a nebulizer wherein the improvement comprises a positive pressure valve. Moreover, an embodiment includes an aerosol holding chamber wherein the improvement comprises a positive pressure valve. A yet further embodiment includes a pressurized metered dose inhaler wherein the improvement comprises a positive pressure valve.

The invention will best be understood by reference to the following detailed description of the preferred embodiment, taken in conjunction with the accompanying drawings. The discussion below is descriptive, illustrative and exemplary and is not to be taken as limiting the scope defined by any appended claims.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a cross sectional view of a mouthpiece associable with a chamber in conjunction with a PP apparatus.

FIG. 2 is a perspective view of a mouthpiece associable with a chamber in conjunction with the PP apparatus.

FIG. 3 is an exploded view of the preferred embodiment.

FIG. 4a is a front view of one embodiment of the PP apparatus.

FIG. 4b is a cross section drawn along line A-A ofFIG. 4a .

FIG. 4c is a back view of one embodiment of the PP apparatus.

FIG. 4d is a cross section drawn along line B-B ofFIG. 4a.

FIG. 4e is a sectional cross section drawn along line C-C ofFIG. 4a.

FIG. 4f is a rear perspective view of the embodiment ofFIG. 4a.

FIG. 5 is a rear perspective of a mouthpiece according to a preferred embodiment.

FIG. 6 is a front perspective view of a mouthpiece with one embodiment of the PP apparatus.

FIG. 7a is a front view of the fitting and manometer port.

FIG. 7b is a cross section drawn along line A-A ofFIG. 7a of the fitting and port.

FIG. 8a is a top view of one embodiment of the slide control.

FIG. 8b is a side view of one embodiment of the slide control.

FIG. 8c is a perspective view of one embodiment of the slide control.

FIG. 8d is a cross section drawn along line A-A ofFIG. 8a.

FIG. 9 is a top perspective view of one embodiment of the slide control.

FIG. 10 is a perspective view of an alternative embodiment of the PP apparatus ofFIGS. 1-3 showing detent notches in conjunction with a mouthpiece.

FIG. 11 is an exploded view of one embodiment showing a slide control having a port.

FIG. 12 is one embodiment of the slide control having a port.

FIG. 13 is one embodiment of the mouthpiece showing the annular sealing ring.

FIG. 14 is one embodiment showing a plurality of detent notches.

FIG. 15 is a side view of one embodiment of the control valve showing the port.

FIG. 16 is a concave perspective view of the slide control showing the port.

FIG. 17 is a concave bottom view of the slide control showing the port.

FIG. 18 is an exploded view of an alternative embodiment of the PP apparatus ofFIGS. 8-10.

FIG. 19 is a cross-sectional view of the PP apparatus ofFIG. 18.

FIG. 20 is a perspective view of a duck-bill valve used in the PP apparatus ofFIGS. 18-19.

FIG. 21 is a cross-sectional view of the duck-bill valve ofFIG. 20.

FIG. 22a is a front exploded view of one embodiment of the PP apparatus in conjunction with a mouthpiece and associable with a spacer.

FIG. 22b is a rear exploded view of one embodiment of the PP apparatus in conjunction with a mouthpiece and associable with a spacer.

FIG. 22c is a front view of one embodiment of a valve showing the baffle.

FIG. 23 is a perspective view of one embodiment of a PP apparatus in association with a nebulizer.

FIG. 24 is an exploded view of one embodiment of the PP apparatus and a mouthpiece.

FIG. 25 is a perspective view of one embodiment of the PP apparatus in an open position and a mouthpiece.

FIG. 26 is a perspective view of one embodiment of the PP apparatus in a semi-open position and a mouthpiece.

FIG. 27 is an exploded view of one embodiment of the PP apparatus showing the disc and a mouthpiece.

FIG. 28a is a top view of one embodiment of the PP apparatus and a mouthpiece.

FIG. 28b is a cross section of one embodiment of the PP apparatus and a mouthpiece showing a plurality of prongs holding the PP apparatus.

FIG. 29 is an exploded view of a PP apparatus associated with a mouthpiece and having an inhalation valve.

FIG. 30 is an exploded view of a PP apparatus associated with a mouthpiece and having an exhalation valve.

FIG. 31 is a further perspective view of one embodiment of the PP apparatus in conjunction with a mask having an opening for association with a chamber.

FIG. 32a is a close up of one embodiment of the PP apparatus in a fully open position in conjunction with a mask.

FIG. 32b is a cross section of one embodiment of the PP apparatus in a fully open position in conjunction with a mask.

FIG. 33a is a close up of one embodiment of the PP apparatus in a partially open position in conjunction with a mask.

FIG. 33b is a cross section of one embodiment of the PP apparatus in a partially open position in conjunction with a mask.

FIG. 34a is a close up of one embodiment of the PP apparatus having a plurality of variable sized flow ports, in conjunction with a mask.

FIG. 34b is a cross section of one embodiment of the PP apparatus having a plurality of variable sized flow ports, in conjunction with a mask.

FIG. 35a is a front exploded view of a close up of one embodiment of the PP apparatus having a plurality of variable sized flow ports, in conjunction with a mask.

FIG. 35b is a rear exploded view of a close up of one embodiment of the PP apparatus having a plurality of variable sized flow ports, in conjunction with a mask.

FIG. 36 is a front view of one embodiment of the PP apparatus showing resistance setting indicia.

FIG. 37 shows a perspective view of a spacer for a pressurized metered dose inhaler with one embodiment of the PP apparatus.

FIG. 38a is a perspective view of one embodiment of the resistance window in the open position.

FIG. 38b is a perspective view of the embodiment ofFIG. 38a with the resistance window in a closed position.

FIG. 39a is a perspective view of one embodiment of the resistance window in the open position.

FIG. 39b is a perspective view of one embodiment of the resistance window in the closed position.

FIG. 40 illustrates an alternative embodiment of the apparatus ofFIGS. 37-39.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

FIGS. 1-3 show one embodiment of an assembly10 for performing positive expiratory pressure (PEP) therapy where the assembly incorporates a positive pressure (PP) device having a PP valve12. The assembly10 includes an aerosol delivery apparatus, such as anaerosol holding chamber14, and a patient respiratory system interface, such as amouthpiece16 and/or mask attachable to the output end of the aerosol delivery apparatus. The PP valve12 may be located on the aerosol delivery apparatus or the patient respiratory system interface. The assembly10 combines the aerosol delivery apparatus, mouthpiece, and PP valve into a tool for use in both positive expiratory therapy and administration of a substance, such as a medicament, in aerosol form. Any aerosol delivery apparatus suitable for generating an aerosol of the desired substance may be used.

In the embodiment ofFIGS. 1-3, abackpiece18 is attachable to theinlet20 of theaerosol holding chamber14. A metered dose inhaler (not shown) may be connected with thebackpiece18. Themouthpiece16 is attachable to the outlet end22 of theaerosol holding chamber14. The PP valve12 is generally locatable at the outlet end22 of theaerosol holding chamber14.FIG. 3 depicts an exploded view of the PEP assembly showing anannular valve24 positioned between theoutlet end22 and themouthpiece16. More details on theaerosol holding chamber14 disclosed inFIGS. 1-3 may be found in U.S. Pat. No. 4,470,412 and U.S. patent application Ser. No. 09/287,997 incorporated above.

In the embodiment depicted inFIGS. 1 and 2, theaerosol holding chamber14 is provided with anannular valve24 located at itsoutlet end22. Theannular valve24 allows the user to inhale medicament from thechamber14, but prevents exhalation back through the chamber. As illustrated inFIGS. 1-3, and in more detail inFIGS. 4a-4f,5 and6, a PP valve12 may be formed in amouthpiece16. The PP valve12 includes aslide control26 that is movably positioned relative to aresistance window28. Theslide control26 is variably maneuverable to cover or uncover theresistance window28 in a continuous manner. Further, the movement of theslide control26 includes, but is not limited to, covering or uncovering, and/or opening or closing, theresistance window28 or any variations thereof.

The PP valve12 may be located on or in conjunction with amouthpiece16. An exemplary embodiment of themouthpiece16 shown inFIGS. 4a-4f has adistal end30 and aproximal end32. Commonly, theproximal end32 of the mouthpiece is inserted or associated with the mouth or nostrils of the user. Additionally, thedistal end30 of a mouthpiece may or may not be associated with an aerosol delivery apparatus and the mouthpiece alone may be configured to constitute a PEP device.

Generally, in one exemplary embodiment, the PP valve12 may be located at or near thedistal end30 of themouthpiece16. Although, it is understood that the PP valve12 may be located anywhere on the mouthpiece1 and its location is not to be limited. In an alternative embodiment, the PP valve12 may be located at or near theoutput end20 of the aerosol delivery apparatus, such as, but not limited to, theaerosol holding chamber14 ofFIGS. 1-3. Generally, the direction of travel of any fluid, particularly an aerosol or nebulizer medicament, is in the direction from theinput end20, through the channel or chamber body, and to or out theoutput end22. This direction of travel frominput end20 to output end22 is referred to as travel from downstream to upstream.

In a preferred embodiment themouthpiece16 is formed of plastic. The plastic may be either rigid or soft. Other materials that can also be used for themouthpiece16 include metal or other materials known to one in the art. In the embodiment depicted inFIGS. 1-3,4a,4b,4c, and4f, atab34 is provided allowing for the connection of acap36, as shown inFIG. 2, to cover theproximal end32 of themouthpiece16. In a preferred embodiment, themouthpiece16 may includeindicia35, or setting indications, representing the resistance setting. Theindicia35 may be in the form of numbers, bars, colors, a series of dots or the like.

In a further embodiment, as shown inFIGS. 7a and 7b, the PP apparatus10 may includes a fitting39 sized for placement over the proximal end of the mouthpiece. The fitting39 includes amanometer port41 extending from the fitting over which a manometer can be attached. In a preferred embodiment the fitting39 is formed of a plastic. The plastic may be either rigid or soft. Other materials that can also be used to form the fitting include metal.

FIGS. 3,8a-8d and9 show an embodiment of theslide control26 of the PP apparatus10. As shown inFIG. 9, in the illustrated embodiment, theslide control26 is of a semi-circular, quarter moon shape. Theslide control26 has a firstlateral side38 concave in shape and a secondlateral side40 opposite thefirst side38. Theslide control26 also has a top42 and a bottom44 surface. From thetop surface42 of theslide control26 extends a tab setting46.

In the illustrated embodiment, the tab setting46 is a uniformly molded projection from theslide control26. In a preferred embodiment, the tab setting46 has smooth edges for easy engagement with the finger, thumb or appendix of the user. The tab setting46 may also have a serrated edge or any other edge known in the art. When assembled with themouthpiece16, the tab setting46 projects through the mouthpiece from thetab window48. The user of the device manipulates the tab setting46 in such a manner as to cause, either directly or indirectly, the movement of theslide control26 thereby varying the opening of theresistance window28.

In the embodiment ofFIGS. 1-3,4a-4f,5 and6, thetab window48 is arcuate in shape, parallel to the contour of the circumference of themouthpiece16. Referring toFIG. 4f, theslide control26 is preferably seated in achannel50 located on themouthpiece16. Theslide control26 is held within thechannel50 by at least one tooth52. Located on one or both of the walls of thechannel50 is a steppedsurface54 as shown inFIG. 5.

In the embodiment shown inFIGS. 8a and 6, thecontrol arm56 of theslide control26 is shown having afinger protection58 from one end of theslide control26. In another embodiment, theslide control26 may have acontrol arm56 located on both ends of theslide control26. Thefinger projection58 is capable of engagement with the steppedsurface54 inside the mouthpiece shown inFIGS. 4c and 5. In the illustrated embodiment, the steppedsurface54 includes a series of ribs extending a variable length of the internal diameter of themouthpiece16. In another embodiment, as shown inFIG. 30, the steppedsurface54 may also be located along thetab window48. Therefore, the location of the steppedsurface54 may vary while remaining engageable by thecontrol arm56. Additionally, the steppedsurface54 may be located on either or both of the internal walls of thechannel46. In the embodiment ofFIGS. 4a-4f and8a-8d, theslide control26 is of a flexible material so that thecontrol arm56 can slide across the uppermost surface of the ribs projecting from the steppedsurface54. When the desired opening of theresistance window28 is obtained, thecontrol arm56 engages in a semi-locked manner the ribs projecting from the steppedsurface54.

The end of theslide control26 opposite thecontrol arm56 may either be provided with afinger projection58 or may be smooth. The length of theslide control26 extending from the tab setting46 to the end of thecontrol arm56 opposite theprojection58 is generally the length of theresistance window28. Thisresistance control length60 is at least the length that theresistance window28 can be opened allowing for exhalant to exit thewindow28. In a preferred embodiment, theslide control26 is manufactured of a plastic. The plastic may be either rigid or soft. Other materials that can also be used for theslide control26 include metal or other materials known in the art.

In general, as shown inFIG. 5, theresistance window28 may be an opening of any size or shape in the walls defining thechannel46 in themouthpiece16 which, in conjunction with the illustrated embodiment of theslide control26, provides an opening in themouthpiece16 to produce sufficient pressure during exhalation of the patient performing PEP therapy. For example, theresistance window28 may be formed with straight or slanted edges. If the edges are slanted, this provides a steeped effect to theresistance window28. If the desired exhalation pressure is determined to range from 10-20 cm H₂O, then theresistance window28 in conjunction with theslide control26, acting as a cover or closure mechanism for theresistance window28, are sized in such a manner as to provide an appropriate opening for the desired exhalation pressure to be produced. As one example, if theresistance window28 is generally narrow, then the length of the window may be of a longer length so as to provide a large enough opening through which PEP therapy is performed. Interdependent in the relationship is theresistance window length60 of thecontrol arm26. In the above example, theresistance window length60 of thecontrol arm26 is generally longer to cover the desired amount of theresistance window28. Thecontrol arm26 may provide a continuously adjustable variable resistance window between a first position where the control arm completely blocks thewindow28, to a second position where the control arm leaves the window completely open.

An alternative embodiment of anassembly100 for performing PEP therapy is shown inFIGS. 10-17. This embodiment is similar to the embodiment ofFIGS. 11-13, but utilizes a variation of the resistance window and slide control in thePP valve112. In theassembly100 ofFIGS. 10-17, theresistance window128 andslide control126 are positioned in themouthpiece116. The tab setting146 of theslide control126 is of a flexible material. Adetent158 protrudes from the firsttab setting face156 located on theconcave side125 of theslide control126. As shown inFIG. 15, aposition indicating rib159 is located on the tab setting146 opposite thedetent158. In the illustrated embodiment, therib159 is shown as a generally rectangular protrusion from the surface of the tab setting146. Yet, therib159 may be any shape protrusion, such as but not limited to circular, triangular. Further, therib159 may not be a protrusion at all but rather is a concave marking on the surface of the tab setting146. Therib159 has at least the function of indicating to the user the extent of the opening of theresistance window128. Therefore, one skilled in the art can envision a variety of marking, shapes, indents or protrusions, or colors which serve at least the function of indicating the extent of the opening of theresistance window28.

Thedetent158 located on the tab setting146 is associated with at least onedetent notch154 as shown inFIGS. 10 and 14. The flexible tab setting146 is movable within thetab window148. The one ormore detent notches154 are preferably located along the boundary of thetab window148 andindicia135, representative of exhalation effort corresponding to the position of theslide control126, are arranged adjacent the respective detent positions.FIGS. 10 and 14 show a plurality ofdetent notches154. In operation, the flexible tab setting146 is moved along thetab window148. Thedetent154 located on the first tabfitting face125 of the tab setting146 moves into and out of engagement with thedetent notches154. Movement along the boundary and engagement with thedetent notches154 removably fixes theslide control126 in a variety of positions. Each varied position provides for a further opening or closing of theresistance window128. Further, in operation, thedetent158 is not limited to being engaged with a detent notch but may be engaged or seated at any point along the boundary. Engagement with, or seating within, adetent notch154 of adetent158 provides for a variable securely fixed opening of theresistance window128. Eachdetent notch154 may correspond to a particular size opening or pre-set opening of theresistance window128. Therefore, by engagement of thedetent158 within thedetent notch154, the user may be provided with a presetresistance window opening128. Yet, thedetent notch154 may also be positioned anywhere along the boundary providing for a continuously variableresistance window opening128.

Theslide control126, as shown inFIGS. 15,16 and17 has located therein aport143. Theport143 may be of any size or shape and in the illustrated embodiment is generally a rounded triangle having an elongated point. Theport143 operates in conjunction with theresistance window128. In the embodiment illustrated inFIGS. 10-17, the size of the opening through which the exhalant passes is determined by how much of theport143 is left uncovered or open and aligned with theresistance window128. Theslide control126 is provided with aclosure area145, as shown inFIG. 16. Further, theslide control126 is provided additionally with aport area160. When theresistance window128 is closed or not open and thereby not allowing for the exiting of any exhalant, theclosure area145 of theslide control126 is congruent with or aligned with theresistance window128. As theslide control126 is gradually moved, theport area160 containing theport143 is brought into alignment with theresistance window128 in themouthpiece116. In this manner, a continuously variable opening is provided. For example, as theslide control126 moves aligning a greater and greater amount of theport143 with theresistance window128, a greater opening or path for the exhalant is provided.

As described above, and similar to the embodiment ofFIGS. 1-3, theslide control126 is seated in achannel150 located on themouthpiece116. Theslide control126 is slidably movable within thechannel150 in the manner described above so as to continuously variably align theport160 with theresistance window128. In the embodiment of theslide control126 illustrated inFIGS. 13,16, and17, a retainingridge162 fits into thechannel150 thereby holding theslide control126 in its desired position throughout its range of motion in the mouthpiece. The desired position of theslide control126 is as close as possible to theannular sealing ring164 shown inFIG. 13. One function of theannular sealing ring164 is to prevent leakage of the exhalant to ensure that the exhalant to the greatest extent exits from theresistance window128. In a further embodiment, thePP valve112 may optionally be provided with at least one locating ring or post166 to help maintain theslide control126 in alignment. As with the embodiment ofFIGS. 1-3, a patient's exhalation effort is controlled by adjusting the slide control over the resistance window so that the patient's exhaled air, which is prevented from entering theaerosol chamber114 by theannular valve124 and a baffle (not shown), must exit through the resistance window and provide a desired exhalation resistance. More specifically, during inhalation theinner diameter127 of the annular valve124 (FIG. 11) unseats from the baffle (not shown) on theoutput end122 of the aerosol holding chamber and permits passage of fluid. Substantially simultaneously, theexhalation flange186 of thevalve124 flexes to seal against the outer ridge188 (FIG. 13) formed inside themouthpiece116 to prevent ambient air from entering the mouthpiece. During exhalation, the process is reversed and theinner diameter127 prevents exhalant from entering the aerosol holding chamber while theexhalation flange186 flexes away from theouter ridge188. Thus, the exhalant preferably passes through theresistance window128 and may escape to the outside between the exhalation flange and the mouthpiece, and then through the gap between the mouthpiece and aerosol holding chamber.

Referring toFIGS. 18-21, an alternative embodiment of anassembly210 for PEP therapy combined with an aerosol delivery apparatus is shown. The aerosol delivery apparatus includes achamber housing214 having aninput end220 and anoutput end222. Thechamber housing214,input end220, andoutput end222 define aninterior space223. The apparatus may also include an elastomeric backpiece which may be similar to the backpiece in the embodiment shown inFIGS. 1-3. Theoutput end222 of thechamber housing214 is shaped to receive themouthpiece216 and includes lockingtabs281 and aprotrusion283. Theprotrusion283 is preferably annular in shape. The lockingtabs281 are spaced apart around the outside of theoutput end222.

Referring toFIGS. 18-19, themouthpiece assembly216 is preferably substantially similar to that illustrated inFIGS. 10-15. The mouthpiece assembly includes anannular sealing ring224, and a resistance window defined by agap225 in the sealing ring. Aslide control226 is slidably seated in achannel250 between the annular sealing ring and support posts or a support ring. The tab setting246 protrudes from thetab window248 in themouthpiece216. The continuously variable resistance function is achieved as described above, using either embodiment of slide control and nozzle described above.

Themouthpiece assembly216 is connected to theoutput end222 of thechamber housing214 by placing theapertures284 over the lockingtabs281. As with the embodiment ofFIGS. 1-3 and10-17, in the embodiment ofFIGS. 18-21 acontainment baffle275 may be integrally formed with thechamber housing214 from a single piece of material and located near theoutlet end222. As shown inFIG. 18, thecontainment baffle275 includes connectingmembers276 that extend from the edge of the containment baffle to the inner diameter of theoutput end222 in the chamber housing.Vents277 are defined between the outer perimeter of the containment baffle and the inner diameter of the outlet end of the chamber housing and are separated by the connecting members. Thevents277 are arcuate in shape and conform to the outer perimeter of thecontainment baffle275. In a preferred embodiment, the containment baffle is dome-shaped where the concave end points towards thechamber223. In alternative embodiments, the containment baffle may be any of a number of geometric shapes.

Avalve278 having avalve member279 and avalve seat280 is shown. Thevalve seat280 preferably comprises the rim of the valve and the corresponding raisedlip283 on theoutlet end222 of thechamber housing214. The valve member has a sealing surface that preferably forms between two parallel portions, or lips, of the valve. In a preferred embodiment, the valve material seals against itself when fluid flows against a predetermined flow direction of the valve. In the embodiment shown, the valve is a duck-bill valve where thevalve seat280 is positioned axially away from the valve opening. Thevalve278 defines a central open area toward the end having the valve seat. Thevalve member279, shown as parallel sealing lips inFIGS. 18-21, acts to allow passage of fluid on inhalation, but upon exhalation, the lips of the valve member are held together by the force of fluid (e.g. exhaled air) pressing against thewalls285 of the valve member and collapsing the lips of thevalve member279 against each other in a closed position. Thevalve seat280 also provides a seal against thechamber housing214 during exhalation so that exhalant from a patient must be directed through the continuously variable resistance window in the mouthpiece.

In one preferred embodiment, the duck-bill valve278 has a central open area274 at its base that has a diameter of approximately 26.09 millimeters (mm). The width of the lips that form thevalve member279 is approximately 21.35 mm and the angle at which thewalls285 converge is approximately 72 degrees. Also, the height of the duck-bill valve278 measured from theupper portion282 of the valve seat to thevalve member279 is approximately 18.8 mm. Themouthpiece216 for containing thisvalve278 preferably includes aresistance widow gap225 having a length of 59 degrees of arcuate cut in theannular sealing ring224, where the annular sealing ring is approximately 31.4 mm in diameter and has a height of 4.5 mm.

The operation of the apparatus will now be discussed generally with reference to the embodiments ofFIGS. 1-3,10-17 and18-21. At rest, the valve is adjacent to the output end of the chamber housing. In the annular valve embodiment ofFIGS. 1-3 and10-17 the inner portion of the valve covers the vents at the outlet end of the chamber housing. In the duck-bill embodiment ofFIGS. 18-21, the entire outlet end is covered by the valve. For either valve embodiment, the mouthpiece and outlet end of the chamber housing traps the valve in place. Inhalation by the patient causes the sealing portion of the annular valve to move, or alternatively the lips of the duckbill valve to separate, and permit fluid to pass. Fluid from the chamber housing may be inhaled into the patient's respiratory system through the mouthpiece. The patient may then exhale into the mouthpiece.

Exhalation by the patient results in air traveling through the mouthpiece in a direction opposite the predetermined inhalation flow path of the valve. This air, which is blocked from passage through the valve along the inhalation path, then passes along a second path through the resistance window in the mouthpiece. Also, the force of the exhaled air causes the outer portion of the valve to move away from the mouthpiece in a direction towards the chamber housing. As a result, an exhalation pathway is created between the outer portion of the valve and the mouthpiece through which the exhaled air passes out to the atmosphere or some other predetermined location. As described above, the amount of effort that exhalation requires is set by the slide control, which may be set to block the appropriate amount of the resistance window to achieve the desired resistance.

Referring specifically to the duck-bill valve embodiment ofFIGS. 18-21, the duck-bill valve278 assists both in preventing inhalation of ambient air through theresistance window225 and providing an exhalation path for exhalant. When theapparatus210 is assembled (FIG. 19), theupper portion282 of the valve seat seals against theannular sealing ring224 except for the gap in theannular sealing ring224 defining theresistance window225. During inhalation, fluid flows through the central opening274 and out the lips of thevalve member279. Also, theexhalation flange286 flexes toward the proximal end of the mouthpiece and provides a secondary seal against theouter ridge288 inside the mouthpiece. Theouter ridge288 is preferably continuous around the inner circumference of the mouthpiece. Upon exhalation, the lips of thevalve member279 close, the exhalant passes through the resistance window under theupper portion282 of the valve seat positioned adjacent the resistance window opening, and the exhalation flange flexes away from theouter ridge288 and out between theaerosol holding chamber214 andmouthpiece216.

As shown inFIGS. 22a-22c, an embodiment of anapparatus310 for performing PEP therapy is disclosed that may be used with or without an aerosol delivery apparatus. In contrast to the embodiments discussed above, the PEP apparatus ofFIGS. 22a-22c is a standalone PEP device in a mouthpiece incorporating the previously discussed continuous variable resistance window with slide control, and variations thereof, along with a self containedvalve378 that may be similar to that disclosed in the previous embodiments. Thus, thevalve378 need not be found on the outlet end of aseparate chamber extension314 but may be positioned on thedistal end330 of the mouthpiece. As best shown inFIGS. 22b-22c, thevalve378 may be an annular valve. The378 is preferably retained toward thedistal end330 of the apparatus by acentral baffle385 supported byradial spokes386. In one embodiment, thePEP apparatus310 is formed of anattachable mouthpiece section316 and abaffle section317. The mouthpiece and bafflesections316,317 may be removably joined using snap-fit, threaded or other known attachment schemes. In another alternative embodiment, the mouthpiece and bafflesections316,317 may be integrally molded or welded shut to form a non-removable, unitary piece. Anextended inlet314, without any valves, may be used with the stand-alone PEP device310 to enhance delivery of any medicine to the patient's respiratory system. One function of the extended inlet is to provide a chamber for the dispensed particles from the pressurized metered dose inhaler. When desired, a pressurized metered dose inhaler may be coupled to the extended inlet with a backpiece and medicament supplied from the pressurized metered dose inhaler can be delivered directly to the user.

Although the embodiments ofFIGS. 1-22 illustrate annular and duck-bill valves24,124,278,378, any of a number of other valve configurations may be used. A preferred valve is capable of passing a fluid moving in a first direction along a first path and also capable of passing a fluid moving in an opposite direction along a second path. In the example valves discussed above, inhalation draws fluid through a central opening in the valve while the perimeter of the valve prevents fluid flow. In the above examples, exhalation closes the path through the central opening and directs fluid along a second path around the perimeter of the valve. Other paths may also be used.

FIGS. 23-28 illustrate another embodiment of aPEP apparatus410. As best shown inFIG. 23, thePEP apparatus410 has a patient respiratory system interface, such as amouthpiece416, on aproximal end432 and may be connected with an aerosol delivery apparatus, in this example anebulizer414, at adistal end430. The PEP apparatus includes aPP valve412 positioned on top of themouthpiece416. ThePP valve412 preferably consists of acover417 that may be removably attached to a receiving area419 (FIG. 24) on themouthpiece416. The cover has aresistance window428 and atab window448 extending through a top surface. Aslide control426 in the form of a disk withvents460 extending through the thickness of the disk is movably positioned under thecover417. A one-way valve423 is positioned between theslide control426 and the top of themouthpiece416 to allow air exhaled into theproximal end432 to escape through theresistance window428 while preventing any air from entering through the resistance widow during inhalation.

InFIGS. 23-28, theresistance window428 is shown generally as a pie-slice shaped cut-out with the point of the pie-slice removed so as to form a concave edge. Theresistance window428 may be any shape and should not be limited by the illustrated embodiment. Further, a plurality ofresistance windows428 may form thePP valve412. The number ofwindows428 is not intended to be limited by the illustrated embodiment. In the illustrated embodiment ofFIGS. 23-28, and particularlyFIG. 27, theslide control426 is shown as a circular disc having a pie-slice shaped cut-outs with the point of the pie-slice openings therein which correspond to the openings of theresistance window428. In operation, aligning theopenings460 of the disc with theresistance window428 controls the opening of the continuouslyvariable resistance window428. When theresistance windows428 are aligned with thedisc openings460, theresistance windows428 are opened to their fullest extent allowing the resistance of the exhalant exiting thePP valve412 to be lower. When only a small amount of theresistance windows428 are aligned with thedisc openings460, the resistance of the exhalant exiting thePEP apparatus410 is increased. By moving the tab setting446 in thetab window448, the vents may be adjusted in thedisk417 to any of a number of positions, thereby providing a continuously adjustable resistance. In this manner, positive expiratory pressure is controlled.

Referring again toFIG. 23, where thePEP apparatus410 is connected at its distal end to thenebulizer414, the operation of this embodiment will be described. Upon inhalation, the nebulizer will provide an aerosol to the inhaling patient via the mouthpiece. A suitable nebulizer for use with thePEP apparatus410 is a breath-actuated nebulizer such as disclosed in U.S. Pat. No. 6,044,841 issued Apr. 4, 2000 and entitled “Breath Actuated Nebulizer with Valve Assembly Having Relief Piston”, the entirety of which is incorporated herein by reference. During inhalation from thenebulizer414, apiston452 is drawn down by negative pressure created by the inhalation in the nebulizer and ambient air is drawn throughopenings454 in thelid456 of thenebulizer414. The one-way valve459 in thePP valve assembly412 remains shut during inhalation.

Upon exhalation into theproximal end430 of themouthpiece416, a positive pressure builds in thenebulizer414 and the piston acts as a one-way valve to close off the flow of air out of the nebulizer. Now, the exhalant must travel through the one-way valve in thePP valve assembly412, through the slide control and out the resistance window. Preferably theslide control426 under theresistance window428 has been set to the appropriate position for the patient so that effective PEP therapy may be provided. Although the PEP apparatus ofFIGS. 23-27 uses an aerosol delivery apparatus such as thenebulizer414 to restrict air flow through any opening other than thePP valve assembly412, other embodiments, such as shown inFIG. 29 discussed below, are contemplated where a second one-way valve is associated with thedistal end432 of thePEP apparatus410 so that the PEP apparatus may be used in a standalone fashion for PEP therapy. The illustrated embodiment ofFIGS. 23-28 show animproved nebulizer414 associated with aPEP apparatus410 having aPP valve412. The nebulizer may be used alone or in combination with a mouthpiece mountedPP valve412 or mask mounted version of the PP valve discussed below.

FIG. 29 shows an alternative embodiment of thePEP apparatus410 ofFIGS. 23-28 that may be used alone or coupled to a nebulizer or other aerosol delivery apparatus. As shown inFIG. 29, the mouthpiece462 is provided with a one-way inhalation valve assembly463 having a membrane464 captured in an outlet cover465 attached to the distal end466 of the mouthpiece. The flexible membrane preferably covers vents in the outlet cover465 during exhalation and flexes to allow fluid flow during inhalation. As with the embodiment ofFIGS. 23-28, a PP valve assembly467 is positioned on top of the mouthpiece. The PP valve assembly467 differs from thePP valve assembly412 inFIGS. 23-28 in that the slide control468 contains a circular opening469 that is moved by the tab setting469 under a tear-drop shaped resistance window471 in the cover472. The inhalation valve463 allows for fluid to enter the mouthpiece462 but prevents fluid from exiting the mouthpiece. The exhalation valve473 allows for exhalation through the resistance window471 but prevents inhalation of particles or fluid. When assembled, a gap is present between the exhalation valve473 and the slide control468 in order to allow the exhalation valve473 to open upon exhalation. In this manner, the mouthpiece462 is adapted to be used alone and not in conjunction with a nebulizer or other aerosol delivery apparatus.

Although positive expiratory devices have been shown in detail, embodiments of positive inspiratory devices are also contemplated.FIG. 30 shows one embodiment, similar in concept to the embodiment ofFIG. 29, but with thePP valve475 attached in series with the one-way inhalation valve476, rather than in series with the one-way exhalation valve, to provide for resistance upon inhalation only. The arrows drawn inFIG. 30 depict the direction of travel from the downstream end of the mouthpiece478 to the upstream end of the mouthpiece showing that all inhalation must pass through the continuousvariable resistance window480 and theport482 of theslide control484. If desired, in other embodiments PP valves may be placed in series with both the one-way input and one-way output valves to allow for simultaneous control of positive inspiratory and expiratory pressures at the same or different levels.

As discussed above, embodiments of patient respiratory system interfaces aside from the mouthpiece configurations already disclosed are contemplated. APP apparatus510 utilizing amask512 as the interface is illustrated inFIGS. 31-35. The mask may be a standard mask sized for adults or children and constructed of any of a number of materials such as silicon rubber. Themask512 may have a frusto-conical shapedmain section514 sized to cover the patient's mouth and anosepiece section516 sized to cover a patient's nose. Acentral opening518 in themask512 may be used to attach with an aerosol delivery apparatus such as theaerosol holding chamber14 shown inFIGS. 1-3, and other aerosol delivery apparatus. Alternatively, themask512 may be fitted with a one-way valve in thecentral opening518 for use as either a positive expiratory pressure device or a positive inspiratory pressure device. As with the embodiment ofFIGS. 23-28 and29-30, aPP valve assembly520 is positioned on the device so that inspiration and exhalation paths travel off-axis from one another. ThePP valve assembly520 has an adjustablevalve assembly cover534 withtab window522 andresistance window528 openings positioned on it. Theresistance window528 is generally an oblong, tear-drop shape and thetab window522 defines an arcuate opening in thePP valve cover534. The tab window and resistance window may alternatively be rectangular, oval or any other shape. Although the above embodiments illustrate atab window522 located approximately on a top surface of a mouthpiece or on top of a mask positioned approximately adjacent the nose, thetab window522 may be located anywhere on the mouthpiece or mask.

Referring toFIGS. 35a and 35b, thePP valve assembly520 has a fixedopening530 and a set ofdetents532 positioned on a disk-shapedplatform526 that connects to the nosepiece section of the mask throughcomplementary tab542 and slot544 connectors. As best shown inFIG. 35b, thePP valve cover534 has aprotrusion536 sized to cooperate with thedetents532 on theplatform526 so that the valve cover may be moved to predetermined spots when the valve cover is rotated against the platform. Anaxle538 on the valve cover fits into acentral opening540 in theplatform526 so that theresistance window528 is rotatably positionable over theexhalation port530 and thetab window522 lines up with the tab extending from theplatform526.

This embodiment depicts theresistance window528 as a curved tear-drop like shape. Theplatform526 is shown as a circular disc having at least oneport opening530. Theport opening530 may vary in size and shape. The opening formed for the exhalant to pass through is related to the alignment of theresistance window528 with theport opening530. In this embodiment, the resistance window is moveably mounted relative to a fixed slide control portion attached to the mask.Tabs542 on theplatform526 preferably mate withtab receiving regions544 on the end of thenosepiece section516 to retain the platform in a fixed position relative to the mask. Moving the tear-drop shapedresistance window528 past thepart opening530 vanes the exhalant path. In other embodiments, a plurality ofresistance window openings528 may be moved past theport530. Alternatively, there may be a plurality of ports in theslide control526.

As shown inFIGS. 31 and 32a, one end of the tear-drop shapedresistance window528 matches the size of the largest port opening530 at a maximum flow position thereby providing a maximum flow and least resistance in that position. When the valve cover is rotated so that theresistance window528 covers a greater portion of the port, as shown inFIGS. 33a-33b, a smaller exhalant path is created providing greater resistance. As shown inFIGS. 34a-34b, moving the valve cover until the tab reaches the opposite end of the tab window results in the smallest amount of the port being open, the highest airflow resistance and the least flow. It is envisioned that a plurality of size and shape port openings and resistance windows may be used and the disclosure is not to be limited to that depicted in the drawings. Referring toFIG. 36, an embodiment is shown of avalve cover550 havingindicia552 representative of a resistance setting. Theindicia552 are arranged to cooperate with thetab extension554 on the platform to indicate the current resistance setting.

In alternative embodiments, PEP therapy maybe performed with a mouthpiece or mask having the PP valve associated with a backpiece. The mask or mouthpiece may have an extended inlet for association with the backpiece.

Asthmatic medications are commonly supplied in metered dose inhalers, frequently referred to as pressurized metered dose inhalers. Pressurized metered dose inhalers are generally cylindrical canisters with axially extending vent tubes from internal valves. When the external tube or stem of a pressurized metered dose inhaler canister 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 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 inFIG. 37, aPP apparatus600 may be associated with the pressurized metered dose inhaler or the pressurized metered dose inhaler with an aerosol holding chamber. In thePP apparatus600 ofFIGS. 37-39, an L-shapedadapter portion602 holds the pressurized canister and ahorizontal outlet section604 receives the medicament released in aerosol form. A one-way valve606, which may be a flexible membrane, a rigid membrane, hinged door, or other commonly known valve mechanism is positioned at theproximal end608 of thehorizontal outlet section604. To provide the positive expiratory pressure, the one-way valve606 permits inhalation and blocks exhalation so that substantially all exhalation is routed through thevariable resistance window610 adjacent the one-way valve606. Aslide control612 is movable in theresistance window610 by atab614 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 andFIGS. 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. Theproximal end608 of the metereddose inhaler600 with PP functionality may be used by a patient directly or fitted to an adapter on an aerosol chamber such as shown inFIG. 3.FIG. 40 illustrates another embodiment of a pressurized metered doesinhaler620 with a roundproximal end628 that may be used without the need for special mouthpieces or aerosol holding chambers. As with the embodiment ofFIGS. 37-39, the alternative PEP enabled pressurized metereddose inhaler620 has a one-way valve626 that shunts exhalant through aresistance window622 that is continuously adjustable with aslide control624 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 toFIGS. 1-3,5 and9. Particularly, thearrow2 inFIG. 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 fitting39 to the mouthpiece. A manometer is then attached to thefitting port41 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 fitting39 can be removed from the mouthpiece. This fitting39 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 (33)

What is claimed is:

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 ofclaim 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 ofclaim 1, wherein the bypass window and window opening adjustment mechanism are movable into a plurality of overlapping positions.

4. The apparatus ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 6, wherein the window opening adjustment mechanism is positioned over the bypass window.

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

9. The apparatus ofclaim 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 ofclaim 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 ofclaim 1, wherein the patient respiratory system interface comprises a mouthpiece.

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

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

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

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

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

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

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

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

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

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

22. A respiratory apparatus comprising:

a holding chamber extending in a longitudinal direction and comprising input and output ends;

a mouthpiece in fluid communication with and connected to said output end, wherein said mouthpiece comprises:

a first annular wall arranged around and defining an inhalation passageway and extending longitudinally away from an output end of said mouthpiece and towards said holding chamber in said longitudinal direction, said first annular wall having an inner side surface and an outer side surface, wherein said first annular wall has a window formed therein, wherein said window is formed by a notch defined in an edge of said first annular wall, and wherein said inner side surface of said annular wall defines an entirety of an exhaust conduit upstream of said window;

a second annular wall disposed laterally outwardly of said first annular wall and forming a gap between said first and second annular walls;

a one-way inhalation valve member disposed in said inhalation passageway; and

a flow control member extending in said longitudinal direction and positioned in said gap between said first and second annular walls immediately adjacent said outer side surface of said first annular wall, wherein said flow control member is moveable between a first position, wherein at least a portion of said window is open such that exhaust gases can escape through said window during exhalation, and a second position, wherein said flow control member is positioned over and closes said window.

23. The apparatus of claim 22 wherein said one-way inhalation valve member is configured as a duck-bill valve.

24. The apparatus of claim 22 wherein said mouthpiece comprises a patient interface component and a connector component, wherein said connector component is coupled to said output end of said holding chamber.

25. The apparatus of claim 24 wherein said one-way inhalation valve comprises a base portion.

26. The apparatus of claim 25 wherein said base portion is secured between said patient interface component and said connector component.

27. The apparatus of claim 25 wherein said first annular wall seals against said base portion of said one-way inhalation valve member.

28. The apparatus of claim 24 wherein said patient interface component and said connector component are releasably connected.

29. The apparatus of claim 28 wherein said patient interface component and said connector component are releasably connected with a snap-fit.

30. The apparatus of claim 22 wherein said mouthpiece comprises a first opening mating with said holding chamber and a second opening axially spaced from said first opening, wherein said second opening is smaller than said first opening.

31. The apparatus of claim 22 wherein a portion of said mouthpiece has a dome- shaped interior surface.

32. The apparatus of claim 22 wherein said mouthpiece comprises a mask.

33. The apparatus of claim 22 further comprising a backpiece disposed at said input end, said backpiece having an opening shaped and adapted to receive a metered dose inhaler.

Images