WO1999020331A1 - Method and apparatus for delivering aerosolized medication - Google Patents

Method and apparatus for delivering aerosolized medication Download PDF

Info

Publication number
WO1999020331A1
WO1999020331A1 PCT/US1998/021667 US9821667W WO9920331A1 WO 1999020331 A1 WO1999020331 A1 WO 1999020331A1 US 9821667 W US9821667 W US 9821667W WO 9920331 A1 WO9920331 A1 WO 9920331A1
Authority
WO
WIPO (PCT)
Prior art keywords
die
conduit
air
canister
medication
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1998/021667
Other languages
English (en)
French (fr)
Inventor
Thomas Alex Armer
Bryce Burwick Evans
Nahed Mohsen Mohsen
Richard Matthew Pavkov
Atul M. Sudhalkar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SYSTEMIC PULMONARY DEVELOPMENT Ltd
Systemic Pulmonary Dev Ltd
Original Assignee
SYSTEMIC PULMONARY DEVELOPMENT Ltd
Systemic Pulmonary Dev Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to NZ504021A priority Critical patent/NZ504021A/xx
Application filed by SYSTEMIC PULMONARY DEVELOPMENT Ltd, Systemic Pulmonary Dev Ltd filed Critical SYSTEMIC PULMONARY DEVELOPMENT Ltd
Priority to MXPA00003766A priority patent/MXPA00003766A/es
Priority to JP2000516721A priority patent/JP2001520088A/ja
Priority to KR1020007004125A priority patent/KR20010031187A/ko
Priority to AU10847/99A priority patent/AU750459B2/en
Priority to CN98811903A priority patent/CN1285759A/zh
Publication of WO1999020331A1 publication Critical patent/WO1999020331A1/en
Anticipated expiration legal-status Critical
Priority to AU44363/02A priority patent/AU777488B2/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0086—Inhalation chambers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0086—Inhalation chambers
    • A61M15/0088—Inhalation chambers with variable volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A61M15/0095—Preventing manual activation in absence of inhalation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/16—Rotating swirling helical flow, e.g. by tangential inflows

Definitions

  • the present invention relates to methods and apparatus for delivering a
  • Aerosols are increasingly being used for delivering medication for therapeutic treatment of the lungs.
  • inhalers for example, in the treatment of asthma, inhalers
  • MDIs metered dose inhalers
  • DPIs dry powder inhalers
  • the medication is provided by the pharmaceutical manufacturer in a pressurized aerosol canister, with the medication being suspended or dissolved in a liquid propellant such as a chlorofluorocarbon (CFC) or
  • the canister includes a metering valve having a hollow
  • a typical MDI for use with such a canister includes a
  • the housing having an actuator and nozzle.
  • the canister is inserted into the housing with the hollow discharge stem of the canister being received in a bore in the actuator.
  • the housing further defines a flowpath in fluid communication with the nozzle, the flowpath having an outlet at a mouthpiece portion of the housing, such that the aerosolized medication may be inhaled after it exits the mouthpiece portion.
  • the patient either inserts the mouthpiece into the mouth with the lips closed around the mouthpiece, or holds the mouthpiece at a slight distance away from an open mouth. The patient then depresses the canister to discharge the medication, and simultaneously inhales.
  • Existing MDIs suffer from a number of significant disadvantages.
  • One problem with existing MDIs is poor delivery efficiency of the medication. It has been estimated that on average, with existing MDIs, only about 10 percent of the medication dose which is dispensed from the canister actually reaches the lungs where
  • metered dose being delivered in a form which cannot be inhaled into the lungs.
  • micron one-thousandth of a millimeter
  • mouthpiece results in a substantial fraction of the metered dose being delivered in the form of relatively large liquid droplets instead of fine dry particles and/or vapor. Such droplets cannot be inspired, but rather tend to impact the inside of the mouth
  • velocity of the aerosol substantially exceeds the velocity of the patient's breath.
  • spacers improve delivery efficiency, most of the drug which is discharged from the nozzle impacts and sticks on inner surfaces of the spacer, and is therefore unavailable for inhalation by the user. Thus, MDIs with spacers still suffer from unacceptably
  • DPIs still suffer from the problem of impaction and sticking of medication on the inner surfaces of the devices, particularly under certain environmental conditions such as high
  • fraction of the metered dose i.e., the fraction in the form of dry particles of the optimum size
  • the fraction in the form of dry particles of the optimum size is maximized at the exit of the apparatus.
  • velocity of the aerosol at the exit of the apparatus approximately matches the velocity of the patient's inspired breath. It has been another object of the invention to maximize dispersion and mixing of the drug particles in the bolus of an aerosol within an inhaler apparatus. It has been a still further object of the present invention to provide a
  • the bolus of aerosolized medication which exits the apparatus is as short as possible.
  • a further object of the invention has been to provide a method
  • Still another object of the invention has been to provide a method
  • the invention also provides an apparatus and method for synchronizing the actuation of the canister with the patient's inspiratory effort exerted on the mouthpiece of the apparatus. More specifically, the invention provides a metered dose inhaler
  • apparatus including a housing adapted to support a pressurized canister, the housing
  • the housing further including a. generally tubular conduit
  • a nozzle discharge orifice of the actuator and nozzle assembly being positioned
  • the conduit the air tube being oriented so that air flowing out of the air tube outlet is directed so as to impinge on a plume of aerosolized medication discharged from the canister through the nozzle discharge orifice.
  • the mouthpiece causes air to flow into the air tube inlet and out the air tube outlet to
  • the air jet from the air tube also causes the plume to slow down so mat the velocity of the aerosol exiting the device approximately matches the
  • the apparatus is configured so that
  • the nozzle discharge orifice directs a plume toward the open end of the mouthpiece.
  • the air mbe is arranged to direct an air jet away from the open end of the mouthpiece
  • the air tube is supported .within the conduit by one or
  • each spoke being connected at one end to a corresponding passage through the
  • conduit wall to ambient air outside the conduit and at the other end to the inlet of the air tube.
  • the canister is acmated to discharge a plume of aerosol toward the air jet.
  • the nozzle is positioned to direct a plume away from the open end of the mouthpiece toward the far end of the conduit, which end is substantially closed by an end wall.
  • the air mbe is mounted on
  • the apparatus provides an aerosol flow control apparatus, useful for
  • either MDI or DPI devices including a housing defining a conduit, the conduit
  • the medication is arranged within the housing to direct medication into the conduit.
  • dispenser may be a pressurized canister with actuator and nozzle, or alternatively may
  • the end wall includes a plurality of auxiliary air inlets in fluid communication with ambient air outside the conduit, the
  • auxiliary air inlets opening into the conduit adjacent the inner wall of the conduit, in a
  • the conduit furthermore
  • auxiliary air inlets includes a plurality of vortex generators mounted on the inner wall thereof downstream of the auxiliary air inlets, the auxiliary air inlets and vortex generators
  • the vortex generators preferably comprise inwardly directed vanes which are oriented at an angle to the axial direction so as to impart swirl and vorticity to the air flowing over them.
  • the invention further provides an aerosol flow control apparatus for
  • a housing adapted to support the canister between a first position in which the discharge stem of the canister is in an inoperative position to a second position in
  • the housing further including an outlet through which a user can
  • a canister restraint is arranged in
  • the housing is movable from a rest position in which relative movement between the canister body and discharge stem is prevented to a discharge position in which
  • the canister restraint forms a part of, or alternatively is
  • a device such as a bellows or a movable diaphragm piston assembly
  • variable-volume chamber which defines a variable-volume chamber.
  • the inhaler includes a resilient member which urges the canister into the second position upon movement of the canister restraint into its discharge position.
  • a secondary air passage extends through the housing between the primary air passage and ambient air outside the housing, the secondary air passage including a venmri.
  • the variable-volume chamber is in fluid communication with a throat of the venmri, whereby inhalation of a user through the outlet causes a low pressure in the venmri throat so as to evacuate air from the
  • the device can be designed to cause acmation of
  • the canister near the peak of a patient's inspiratory effort.
  • the device preferably further includes means for selectively varying the timing of acmation.
  • the device may include an adjustment screw
  • the screw one direction increases the amount of flow restriction, such that for a given
  • FIG.l is a perspective view of an inhaler in accordance with the
  • FIG. 2 is an exploded view of the inhaler of FIG. 1.
  • FIG. 3 is a cross-sectional view of the inhaler taken along lines 3-3 of
  • FIG. 3A is a partial cross-sectional view showing an alternative
  • FIG. 4 is a cross-sectional view similar to FIG. 3, showing an alternative embodiment of the inhaler.
  • FIG. 5 is a cross-sectional view similar to FIG. 3, showing yet another
  • FIG. 6 is cross-sectional view of the inhaler of FIG. 5 taken on a plane
  • FIG. 7 is a cross-sectional view of still another alternative embodiment
  • FIG. 8 is a perspective view of the trigger which engages and
  • FIG. 9 is side elevational view, partly in cross-section, of yet another embodiment of the invention, showing an alternative arrangement for achieving automatic acmation of a canister responsive to a patient's breath.
  • FIGS. 1-3 depict a first embodiment of an inhaler 10 in accordance
  • the inhaler 10 includes a housing 12 which has
  • a receptacle portion 14 connected to a conduit 16.
  • the receptacle portion 14 is in the
  • the canister 18 forms no part of the present invention.
  • the inhaler apparatus of the present invention is usable with any standard pressurized canister
  • the conduit 16 includes an open end 20 spaced from the receptacle
  • the end wall 24 preferably is generally conical or hemispherical in shape, with an apex of the end wall 24 forming the portion of the
  • the housing 12 further includes an actuator and nozzle assembly 26 supported by the end wall 24.
  • the actuator and nozzle assembly 26 includes a bore 28 which is adapted to receive the hollow discharge stem (not shown in FIGS. 1-3) of the canister 18, and a nozzle discharge orifice 30 in fluid communication with the bore 28.
  • the nozzle discharge orifice 30 is advantageously
  • the inhaler 10 includes an air mbe 34 supported within the conduit 16.
  • the air mbe 34 has an outlet 36 which is spaced downstream of and in opposing relationship with the nozzle
  • the air mbe 34 is a bent mbe which has a generally axial portion 40 which is generally aligned along the conduit's longitudinal axis 32, and a generally radial portion 42 which is attached to the inner wall 44 of the conduit 16.
  • a user exerts an inspiratory effort on the open end 20 of the conduit 16
  • air is drawn from outside the conduit 16 into the air mbe inlet 38, exiting the air mbe outlet 36 in a direction toward the nozzle discharge orifice 30.
  • the portion 40 of air mbe 34 is located and oriented within the conduit 16
  • metering valve of the canister 18 is acmated to discharge a plume of aerosolized
  • plume causes the plume to slow down and be dispersed so as to occupy a larger
  • particles of the optimum size of about one to five microns moving at a relatively low velocity that substantially matches the inspiratory breath velocity, as opposed to relatively large liquid droplets moving at a relatively high velocity. Impaction and sticking of medication within the mouth and tirroat are thereby reduced.
  • the air mbe 34 and conduit 16 can be integrally formed of one piece, with the internal passage of the air mbe 34 extending through the conduit 16 to establish fluid communication with air outside the conduit 16.
  • the air mbe 34 can be formed of a metal mbe bent into the appropriate configuration and attached to the conduit 16 at the inlet end 38.
  • portion 40 may be
  • an obmse angle i.e., between about 90 degrees and 180 degrees, 180
  • attaches to the conduit wall need not be radial, but can be oriented at an acute or
  • the invention further includes feamres which reduce the likelihood of
  • the inhaler 10 includes a plurality of
  • auxiliary air inlets 46 through the end wall 24 and circumferentially spaced therearound at at least two different radii from the nozzle orifice 30.
  • a first circumferential ring of auxiliary air inlets 46 are located adjacent the juncture 48 between the end wall 24 and the inner wall 44 of the conduit 16.
  • a second circumferential ring of auxiliary air inlets 47 are located radially between the juncture 48 and the nozzle orifice 30.
  • the inhaler 10 also includes a
  • vanes 54 are
  • each vane 54 advantageously
  • the vanes 54 are oriented at an angle to the axial direction defined by longitudinal axis 32, so that vorticity and swirl are imparted to air flowing over them.
  • the boundary layer air flow created by auxiliary air inlets 46 encounters the vanes 54, which impart vorticity and swirl to the boundary layer air flow. This vorticity and
  • the inhaler 10 includes a separate mouthpiece 56 which connects to the open end 20 of the conduit 16.
  • the mouthpiece 56 has a reduced diameter portion 58 adapted to be inserted into the mouth of a user of the inhaler 10. After completely exhaling, the user inserts the portion 58 into the mouth with the lips closed around the portion 58, and then begins to inhale, which establishes air flow from the air mbe 34 and through the auxiliary air inlets 46. Once these air flows are established and while continuing to inhale, the user depresses the
  • canister 18 to discharge a metered volume of medication and propellant mixture from
  • the housing 12 is formed in four sections
  • the housing 12 may alternatively be formed in fewer than four
  • the housing 12 may be formed in two sections, a first section
  • the housing 14 may be formed in two sections split on a longitudinal plane through the conduit, the two sections being generally mirror images of each other which are joined together along the plane of symmetry. Nevertheless, for illustration purposes, an embodiment
  • a first section 60 includes the receptacle portion 14, the end wall 24 and actuator and nozzle assembly 26, and a generally cylindrical portion 62 which forms a part of the conduit 16 and is connected to the end wall 24 at the juncture 48.
  • the first section 60 advantageously is integrally formed of one piece, although it may alternatively be formed in multiple pieces which are subsequently joined together.
  • a second section 64 includes a second generally cylindrical portion 66 whose inner and outer diameters are equal to those of the first generally cylindrical
  • the portion 68 has an inner
  • 64 preferably is integrally formed of one piece, although it may alternatively be formed in multiple pieces which are subsequently joined.
  • a third section 72 of the housing 12 includes a third generally cylindrical portion 74 whose inner and outer diameters are equal to those of the
  • second generally cylindrical portion 66 and a reduced diameter cylindrical portion 76 which is telescopingly received within the open downstream end of second generally cylindrical portion 66.
  • the outer diameter of portion 76 is approximately equal to the
  • portion 66 has a diameter which is approximately equal to the
  • the air mbe 34 is mounted on me inner surface of the third section 72 at the juncture between the inner surface 78 and the inner surface 80 of third cylindrical portion 74.
  • a hole 82 through the portion 74 mates with the internal passage of air mbe 34 to provide fluid communication between the inlet 38 of air mbe 34 and ambient air outside the conduit 16.
  • Third section 72 may be integrally formed of one
  • the fourth section of the housing 12 is the mouthpiece 56, which has a
  • the portion 84 is attached to an annular flange 86,
  • portion 84 is approximately equal to the outer diameter of portion 84
  • the housing 12 advantageously is formed of a plastic such as
  • the housing 12 may be manufactured by any suitable technique such as
  • FIG. 3 A shows an alterative embodiment of an actuator and nozzle
  • the actuator and nozzle assembly 26a includes two spaced-
  • impingement of the two plumes aids in creating smaller droplets, which
  • the bore 28a is shown as being elongated in die horizontal direction and
  • orifices 30a are shown as being spaced apart in the horizontal plane.
  • the bore 28a may simply be extended in the vertical
  • FIG. 4 depicts an alternative embodiment of an inhaler 10a in which
  • the hub 40a is analogous to the axial portion 40 of the air mbe 34, and the spokes 42a are analogous to the radial po ⁇ ion 42 of air mbe 34.
  • the hub 40a includes a central cavity 88 of a first diameter, and an outlet passage 36a of a second smaller diameter.
  • the outlet passage 36a is generally coaxial with the conduit 16 and oriented so that air flowing outward therefrom is directed toward the nozzle orifice 30.
  • the internal passages of spokes 42a are connected to outside air by a pair of holes 82a through the cylindrical portion 74a. In the embodiment of the inhaler 10a shown in FIG. 4, there is no section of the housing
  • FIGS. 5 and 6 illustrate yet another embodiment of an inhaler in
  • FIG. 5 schematically depicts
  • FIG. 3 a horizontal cross section analogous to FIG. 3, showing an inhaler 10b in which the aerosol plume is directed away from the user so that the aerosol must reverse
  • FIG. 6 schematically depicts a vertical cross section
  • the inhaler 10b includes a housing 12b defining a conduit 16b which has a first closed end defined by an end wall 90 and a second open end defined by a mouthpiece portion 58b adapted to be
  • the conduit 16b has a first larger internal cross
  • the housing further includes a receptacle portion 14b which penetrates into the conduit 16b at a location between the end wall 90 and the mouthpiece portion 58b.
  • the receptacle portion 14b receives a standard pressurized canister (not shown).
  • the housing 12b further includes an actuator and nozzle assembly 26 arranged at the bottom end of receptacle portion 14b such that the hollow outlet stem of the canister may be inserted into a bore 28 of the
  • actuator and nozzle assembly 26 The details of the actuator and nozzle assembly 26
  • the inhaler 10b includes an internal conduit 92 which is coaxially
  • the internal conduit 92 has an open end 94 spaced
  • the inhaler further includes an air mbe 34b attached to the end wall 90 and coaxially
  • the air mbe 34b intrudes part way into the inner conduit 92 toward the nozzle discharge orifice 30.
  • the inlet 38b of air mbe 34b is connected to ambient air outside the conduit 16b by a hole 98 through end wall 90.
  • mouthpiece will be substantially equal to the velocity of the user's inspired breath
  • FIG. 7 depicts yet another embodiment of the invention providing
  • An inhaler 10c includes a housing 12c having a conduit 16c within which an aerosol plume is created for
  • the conduit 16c is shown to include the air mbe 34 and the
  • auxiliary air inlets 46 may also include the vanes 54 of inhaler 10. Alternatively,
  • the conduit 16c may be a simple straight duct with an open end for the exit of aerosolized medication.
  • the conduit 16c must adapted
  • breath-synchronization feamres of the invention breath-synchronization feamres of the invention.
  • the housing 12c further includes a receptacle portion 14c which is connected to the conduit 16c.
  • the receptacle portion 14c comprises a generally cylindrical sleeve having a longimdinal axis 108 which is oriented at an oblique angle to the longimdinal axis of the conduit 16c.
  • a canister 18 resides within the receptacle portion 14c with its longimdinal axis aligned with the longimdinal axis of the
  • the 18 is an inner sleeve 100.
  • the inner sleeve 100 has an open top end 102 through
  • the sleeve 100 adjacent bottom end 104 has inwardly extending ledges 105 which abut the cap portion 106 of the canister.
  • the canister 18 is slidable within inner sleeve along the direction defined by the
  • the inner sleeve 100 is also slidable within the receptacle portion 14c
  • the receptacle portion 14c has four longimdinal slots 110 circumferentially spaced apart about 90 degrees, two of which receive a pair of diametrically opposite lugs or cam followers 112 extending outwardly from the outer surface of inner sleeve 100.
  • the receptacle portion 14c may have only two slots 110 spaced 180 degrees apart and receiving the lugs 112.
  • the inhaler includes a generally cylindrical cam ring 114 which fits
  • the cam ring 114 has an annular flange
  • Each cam track 120 presents a generally helical surface 124 in facing relationship with one of the lugs 112 protruding
  • cam tracks 120 causes the lugs 112 to ride along the helical surfaces 124 and thereby upwardly advance the inner sleeve 100 in the longimdinal direction
  • a compression spring 126 Resisting this upward movement of the canister 18 is a compression spring 126.
  • the spring 126 is attached to the inner surface of a removable end cap 128 which surrounds the top end 130 of the receptacle portion 14c and the top end 122 of the cam ring 114 to completely enclose the canister 18 in the housing.
  • the end cap 128 When the end cap 128 is thus installed, the spring 126 bears against the end of the canister 18, biasing the canister downward toward the actuator and nozzle
  • the inhaler 10c includes a mechanism which engages the
  • the inhaler 10c includes a piston assembly 132 which is
  • the piston assembly 132 includes a circular disc 136 having a
  • shaft 138 extending centrally therethrough coaxial with axis 134 and protruding outward from both sides of the disc 136.
  • a forked trigger 154 is attached to the head end 150.
  • the trigger 154 is attached to the head end 150.
  • axis 134 to approximately the longimdinal axis 108 of the receptacle portion 14c.
  • the prongs 156 are spaced apart by a distance D which is slightly smaller than the
  • the canister neck 158 contacts inner edge portions
  • canister neck 158 clears the prongs 156 so that movement of the canister 18 toward
  • the prongs 156 include portions 157 which slope gently away from the canister neck 158 in the direction along axis 134 toward the canister.
  • the portions 157 reduce the amount of force required for disengagement of the trigger 154 from the canister neck 158. Movement of the piston assembly 132 in the direction away from the canister is responsive to air pressure within a variable-volume chamber 162 within the
  • the chamber 162 is defined by the disc 136, the housing wall 144, and a flexible diaphragm 164 which connects the disc 136 to d e wall 144 in a substantially air-tight manner.
  • the diaphragm 164 includes a circular portion 166 which lies against the side of disc 136 facing the canister 18, and a skirt 168 which depends from the outer edge of the circular portion 166 and attaches to the housing wall 144.
  • the housing wall 144 comprises a removable
  • circular portion 166 of diaphragm 164 includes a central hole through which the shaft
  • the removable cover 170 includes a recess 172 facing the disc 136
  • conduit 16c is
  • the passage 174 terminates at the end of first section 62c which connects to second section 74c.
  • a passage 178 through a sidewall 180 of the second section 74c is fluidly connected with and forms an extension of passage 174.
  • the passage 178 extends into the internal passage 182 of the air mbe 34.
  • a venmri 184 is inserted into the air mbe passage 182.
  • the venmri 184 includes a restricted portion or throat 186.
  • Air passages 188 extend through the venmri wall in the vicinity of the throat 186.
  • the venmri 184 is disposed in passage 182 such that these air passages 188 align with the passage 178.
  • fluid communication is provided between the venmri throat 186 and the variable-volume chamber 162 by air passages 188, passage 178 in second
  • the trigger 154 begins to move so as to disengage the prongs 156 from the canister neck 158.
  • the decrease in volume is sufficient to move the trigger 154 far enough to totally disengage the prongs 156 from the neck 158, movement of the canister 18 toward the actuator 26 is no longer impeded, and the force of spring 126 moves the canister downward so as to cause
  • the user grasps the ring 114 and rotates it with respect to the housing 12c
  • the spring 152 urges the trigger 154 toward the canister 18 so that the trigger 154
  • inhaler 10c is then ready to be used again.
  • breath-synchronization feamres described above provide an inhaler in which discharge of medication is automatically responsive to the user's inspiratory effort, so that the user does not have to carefully coordinate manual depression of a canister with the inhalation. Furthermore, discharge of medication does not occur immediately upon the user beginning to inhale on the open end of the device, but rather is somewhat delayed until the volume of chamber 162 has decreased enough to cause acmation. It will also be appreciated that the degree of
  • time delay between initiation of a breath and acmation is dependent on a number of
  • the primary factors being the cross-sectional area of the chamber 162 and the
  • inhaler 10c may be designed with appropriate selection of these factors so as to
  • the inhaler 10c provides breath-responsive acmation of the
  • canister 18 which automatically adjusts to the user's rate of inhalation to discharge the medication near the peak of the inhalation, i.e., near the point at which 50 percent of the volume which the user will eventually inspire with a full inhalation has been
  • the inhaler 10c further includes an adjustment screw 190 which extends through the housing 12c into the passage 174 to form a restriction within passage 174. By turning the screw 190 one direction, the screw 190 extends farther into passage 174 to increase the restriction, and by turning the screw 190 the opposite
  • canister 18 in relation to a particular patient's inhalation may be varied by adjusting
  • variable- volume chamber 162 the variable- volume chamber 162
  • FIG. 9 depicts a subassembly of yet another embodiment of an inhaler having feamres for automatic breath acmation of discharge.
  • the forked trigger 154 is eliminated and the diaphragm piston assembly 132 is replaced
  • a resiliently compressible bellows 200 which is disposed between a fixed wall 202 of the housing (not shown) and the canister neck 158.
  • the bellows 200 itself acts as
  • the bellows 200 is advantageously made of stainless steel and has a blind end wall 204 at die end adjacent die canister neck 158, the end wall 204 being integrally formed with me accordion-folded side wall 206.
  • the bellows 200 has a second end wall 208 at d e end adjacent the housing wall 202, the end wall 208 also
  • the second end wall 208 is pierced
  • a tube or needle 210 which establishes an air passage into the interior of the
  • the needle 210 advantageously is a stainless steel mbe similar to a
  • hypodermic needle and is integrally affixed at one end to the end wall 208 by welding
  • the free end 212 of the needle 210 extends is attached
  • the venmri 216 is
  • the mbe 218 and venmri 216 may also be formed of stainless steel.
  • a support/release platform 224 is attached to die blind end wall 204 of
  • the support/release platform 224 contacts the canister neck 158
  • the canister 18 contains an internal spring (not shown) which acts between the canister body and the hollow outlet stem 19 in a direction tending to move the canister 18 away from the actuator 26.
  • the spring constant of the bellows 200 is selected such that the sum of die spring force exerted by the bellows 200 and die force exerted by die internal spring is slightly
  • the inhaler 10c which creates a low pressure within the throat 214 of venmri 216.
  • This low pressure is communicated via me extension mbe 213 and needle 210 to the
  • the pressure within the bellows 200 is less than the atmospheric pressure which surrounds the outside of the bellows 200, and therefore there is an air pressure force exerted on the blind end wall 204 in the
  • the bellows 200 preferably has a spring constant of about 1 pound per
  • the venmri 216 must be sized to create a gage pressure within the throat 214 of about one pound per square inch.
  • die venmri inlet in communication with ambient air via a passage through the conduit wall
  • die venmri inlet may alternatively draw air through one of the auxiliary air inlets 46 in the end wall 24, or through any arrangement having the venmri inlet outside the primary air passage
  • bellows 200 being attached to die forked trigger 154, and die spring 152 being

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  • Health & Medical Sciences (AREA)
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  • Anesthesiology (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicinal Preparation (AREA)
  • Nozzles (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Colloid Chemistry (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
PCT/US1998/021667 1997-10-17 1998-10-15 Method and apparatus for delivering aerosolized medication Ceased WO1999020331A1 (en)

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NZ504021A NZ504021A (en) 1997-10-17 1997-10-17 Method and apparatus for delivering aerosolized medication having air discharged through air tube directly into plume of aerosolized medication
MXPA00003766A MXPA00003766A (es) 1997-10-17 1998-10-15 Metodo y aparato para surtir medicamento en aerosol.
JP2000516721A JP2001520088A (ja) 1997-10-17 1998-10-15 エアロゾル化薬剤の送出方法と装置
KR1020007004125A KR20010031187A (ko) 1997-10-17 1998-10-15 에어로졸 화된 약품의 전달방법 및 그 장치
AU10847/99A AU750459B2 (en) 1997-10-17 1998-10-15 Method and apparatus for delivering aerosolized medication
CN98811903A CN1285759A (zh) 1997-10-17 1998-10-15 输送气雾化药品的方法及装置
AU44363/02A AU777488B2 (en) 1997-10-17 2002-05-23 Method and apparatus for delivering aerosolized medication

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US08/954,352 1997-10-17
US08/954,352 US5954047A (en) 1997-10-17 1997-10-17 Methods and apparatus for delivering aerosolized medication

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ES2348495T3 (es) 2010-12-07
CA2565964C (en) 2008-06-10
EP1627655A2 (en) 2006-02-22
TR200001033T2 (tr) 2000-11-21
US5954047A (en) 1999-09-21
JP2001520088A (ja) 2001-10-30
ATE311913T1 (de) 2005-12-15
EP1591137A2 (en) 2005-11-02
JP2009183734A (ja) 2009-08-20
JP5352630B2 (ja) 2013-11-27
MXPA00003766A (es) 2002-04-09
EP1591137A3 (en) 2005-11-23
JP2010115543A (ja) 2010-05-27
KR20010031187A (ko) 2001-04-16
CA2243175C (en) 2008-11-18
AU750459B2 (en) 2002-07-18
NO983631D0 (no) 1998-08-07
JP2011098224A (ja) 2011-05-19
EP1591137B1 (en) 2010-04-07
CA2243175A1 (en) 1999-04-17
DK0911048T3 (da) 2006-04-18
DK1591137T3 (da) 2010-07-05
AU1084799A (en) 1999-05-10
NZ504021A (en) 2003-04-29
CA2565964A1 (en) 1999-04-17
EP0911048B1 (en) 2005-12-07

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