CA2552468C - Medicament inhaler - Google Patents

Medicament inhaler Download PDF

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Publication number
CA2552468C
CA2552468C CA002552468A CA2552468A CA2552468C CA 2552468 C CA2552468 C CA 2552468C CA 002552468 A CA002552468 A CA 002552468A CA 2552468 A CA2552468 A CA 2552468A CA 2552468 C CA2552468 C CA 2552468C
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CA
Canada
Prior art keywords
yoke
cup
spool
inhaler according
ribbon
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.)
Expired - Lifetime
Application number
CA002552468A
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French (fr)
Other versions
CA2552468A1 (en
Inventor
Lawrence Keane
David O`Leary
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Norton Healthcare Ltd
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Norton Healthcare Ltd
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Publication date
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Publication of CA2552468A1 publication Critical patent/CA2552468A1/en
Application granted granted Critical
Publication of CA2552468C publication Critical patent/CA2552468C/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0005Details of inhalators; Constructional features thereof with means for agitating the medicament
    • A61M15/0006Details of inhalators; Constructional features thereof with means for agitating the medicament using rotating means
    • A61M15/0008Details of inhalators; Constructional features thereof with means for agitating the medicament using rotating means rotating by airflow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A61M15/0046Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier
    • A61M15/0048Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier the dosages being arranged in a plane, e.g. on diskettes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • A61M15/0068Indicating or counting the number of dispensed doses or of remaining doses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • A61M15/0068Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/007Mechanical counters
    • A61M15/0071Mechanical counters having a display or indicator
    • A61M15/0078Mechanical counters having a display or indicator on a strip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0086Inhalation chambers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0091Inhalators mechanically breath-triggered
    • A61M15/0093Inhalators mechanically breath-triggered without arming or cocking, e.g. acting directly on the delivery valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0091Inhalators mechanically breath-triggered
    • A61M15/0096Hindering inhalation before activation of the dispenser
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06MCOUNTING MECHANISMS; COUNTING OF OBJECTS NOT OTHERWISE PROVIDED FOR
    • G06M1/00Design features of general application
    • G06M1/04Design features of general application for driving the stage of lowest order
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06MCOUNTING MECHANISMS; COUNTING OF OBJECTS NOT OTHERWISE PROVIDED FOR
    • G06M1/00Design features of general application
    • G06M1/22Design features of general application for visual indication of the result of count on counting mechanisms, e.g. by window with magnifying lens
    • G06M1/24Drums; Dials; Pointers
    • G06M1/246Bands; Sheets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0091Inhalators mechanically breath-triggered
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/16Rotating swirling helical flow, e.g. by tangential inflows

Abstract

A new and improved inhaler includes an accurate and consistent mechanical dose metering system that dispenses dry powdered medicament in discrete amounts or doses for patient inhalation, a pressure relief system that manages pressure within a medicament reservoir of the inhaler to ensure consistently dispensed doses, and a dose counting system indicating the number of doses remaining in the inhaler

Description

MEDICAMENT INHALER

This is a divisional application of Canadian Patent Application No. 2,407,262 filed on June 23, 2001.
Field of the Disclosure The present disclosure relates to an apparatus and method for administering medicament for inhalation by a patient and, more particularly, to a dry powdered medicament inhaler.

Background of the Disclosure Metered dose medicament inhalers are well known for dispensing medicament to the lungs of a patient, for treating asthma for example. Existing types of medicament dispensing inhalers include pressurized propellant inhalers, aqueous solution inhalers, and dry-powdered inhalers.

U.S. Patent No. 5,503,144 to Bacon, for example, shows a dry powdered inhaler. The inhaler includes a reservoir for containing a dry powdered medicament, a metering chamber for removal of the powdered medicament from the reservoir in discrete amounts, and an air inlet for entraining the removed powdered medicament through a mouthpiece upon patient inhalation Another example is U.S. Patent No. 5,971,951 to Ruskewicz, which shows an inhaler including a motor driven cam mechanism for extruding aqueous medicament through a porous membrane to form a medicament aerosol for inhalation by a patient. The inhaler also includes sensors, circuitry and a microprocessor that determines the rate of patient inhalation and operates the extrusion mechanism only upon adequate inhalation levels.

A pressurized propellant, or "aerosol" inhaler is shown in U.S. Patent No.
5,447,150 to Bacon, which also discloses a siinple, mechanical actuation assembly for ensuring that medicatnent is dispensed from the inhaler only upon adequate inlialation by a patient. The actuation assembly worlcs by applying a pre-load to a valve of the aerosol container sufficient to cause a dose release, but prevents the release by applying a pneumatic resisting force. The dose of inedicament is then released upon a patient inhalation strong enough to move a door within the assembly, which in turn releases the pneumatic resisting force.

What is still desired, however, is a new and improved inhaler for admiiustering medicament for patient inhalation. Preferably, the new and improved inhaler can be used with dry powdered medicament. In addition, the new and improved inhaler will preferably include mechanical assemblies for metering doses of inedicanient, managing medicament reservoir pressure, and counting the number of doses remaining in the inhaler.

Summary of the Disclosure The present disclosure, therefore, provides a new and improved medicament inhaler having a unique dose metering system. The inhaler includes a mouthpiece for patient inhalation, a delivery passageway for directing an inhalation induced air flow through the mouthpiece, a chamiel extending from the delivery passageway, and a reservoir for contailling medicament, with the reservoir having a dispenser port connected to the channel. In a preferred form, the dose metering system includes a cup received in the channel, which is movable between the dispenser port and the delivery passageway, a cup spring biasing the cup towards one of the dispenser port and the passageway, and a yoke movable between at least two positions. The yoke includes a ratchet engaging the cup and preventing movement of the cup when the yoke is in one of the positions, and allowing movement of the cup when the yoke is in another of the positions.
3 l 066-3 The present disclosure also provides a medicament inllaler having a uniciue reservoir pressure system. The inhaler includes a sealed reservoir having a dispenser port, and a channel comnruidcatiuig with the dispenser port, and a cup assambl}, movably received in the channel. In a preferred form, the pressure system includes a pressure relief port in the chatmel, and a conduit providing fluid communication between an interior of th.e sealed reservoir and tlie pressure relief port of the chauiel. The cup assembly inclucles a recess adapted to receive medicatnent when aligned with tlle dispenser port, a first sealiulg surface. adapted to seal the dispenser port when the recess is mialigned with the dispenser port, and a second sealing stuface adapted to seal the pressure relief poi-t when the recess is aligned with the dispenser port and unseal the pressure relief port when the recess is unaligned with the dispenser port.

The present. disclosure additionally provides a medicament inhaler having a unique dose coLUiter. The inhaler includes a mouthpiece for patient inhalation, a dose metering system including a pawl movable along a predetermined path during the metering of a dose of inedicarnent to the mouthpiece by the dose metering system, and a dose counter.
In a preferred form, the dose counter includes a bobbin, a rotatable spool, and a rolled ribbon received on the bobbin, rotatable about ail axis of the bobbin. The ribbon has indicia thereon suocessively extending between a first end of the ribbon secured to the spool and a second end of the ribbon positioned on the bobbin. The dose counter also includes teeth extending radially outwardly from the spool into the predetermined path of the pawl so that the spool is rotated by the pawl and the ribbon advanced onto the spool during tlie inetering of a dose to the mouthpiece.

Thus, the present disclosure provides a new and improved inhaler including a sinlple, accurate and consistent mechanieal dose metering systenl that dispenses dry powdered -nedicwnent in discrete amounts or doses for patient inhalation, a reservoir pressure system that ensures consistently dispensed doses, and a dose cormter indicating the number of doses remaisiing in the inhaler.

In accordance with another aspect of the invention, there is provided a medicament inhaler comprising: a mouthpiece for patient inhalation; a delivery passageway for directing an inhalation induced air flow through the mouthpiece; a channel extending from the delivery passageway; a reservoir for containing medicament, the reservoir having a dispensing port connected to the channel; a cup received in the channel and movable between the dispensing port and the delivery passageway; a cup spring biasing the cup towards one of the dispensing port and the passageway; and a yoke movable between at least two positions and including a ratchet engaging the cup and preventing movement of the cup when the yoke is in one of the positions and allowing movement of the cup when the yoke is in another of the positions.

In accordance with yet another aspect of the invention, there is provided a medicament inhaler comprising: a mouthpiece for patient inhalation; a cover moveable to open and close the mouthpiece; a delivery passageway for directing an inhalation induced air flow through the mouthpiece; a channel extending from the delivery passageway; a reservoir for containing medicament, the reservoir having a dispensing port connected to the channel; a cup received in the channel and movable between the dispensing port and the passageway; a cup spring biasing the cup towards one of the dispensing port and the passageway; and a yoke movable between at least two positions and including a ratchet engaging the cup and preventing movement of the cup when the yoke is in one of the positions and allowing movement of the cup when the yoke is in another of the positions; at least one moveable cam including three successive cam surfaces; a spring biasing the yoke against the cam such that the movement of the cam 3a causes the yoke to successively engage the cam surfaces and move the yoke between three positions wherein the ratchet is adapted to prevent movement of the cup to the passageway when the yoke is in two of the three positions and allow movement of the cup when the yoke is in a third of the three positions; and wherein the at least one moveable cam is secured to the cover for movement therewith, whereby opening and closing the mouthpiece causes the yoke to move between the three positions of the yoke.

3b Further features and advantages of the presently disclosed inhaler will become more readily apparent to those having ordinary sltill in the art to which the present disclosure relates from the drawings and the detailed description.

Brief Description of the Drawings So that those having ordinaty skill in the art will more readily understand how to construct a dry powdered medicament inhaler in accordance witli the present disclosure, a preferred embod'unent is described below with reference to the drawing figures wherein:
FIG. 1 is a first side isometric view of a dry powdered medicament inhaler according to the present disclosure;

FIG. 2 is an exploded, second side isometric view of the inhaler of FIG. 1;

FIG. 3 is a second side isometric view of a main asseinbly of the inhaler of FIG. 1;
FIG. 4 is a second side isometric view of the main assembly of the inhaler of FIG.
1, shown with a yoke removed;

FIG. 5 is an exploded first side isometric view of the main assembly of the inhaler of FIG. 1;

FIG. 6 is an exploded enlarged isometric view of a medicatnent cup of the iiihaler of FIG. 1;

FIG. 7 is an exploded first side isometric view of a hopper and a de-agglomerator of the inhaler of FIG. 1;

FIG. 8 is an exploded second side isometric view of the hopper and a swirl cliamber roof of the de-agglomerator of the inhaler of FIG. 1;

FIG. 9 is an exploded first side isometric view of a case, cams and a moutlapiece cover of the inhaler of FIG. 1;
FIG. 10 is an enlarged side isometric view of one of the cams of the inhaler of FIG.
1;

FIG. 11 is a second side isometric view of the yoke of the inhaler of FIG. 1;

FIG. 12 is a first side isometric view of the yoke of the inhaler of FIG. 1, showing a ratchet and a push bar of the yoke;

FIG. 13 is a schematic illustration of lateral movement of a boss of the medicament cup in response to longitudinal movenlent of the ratchet and the push bar of the yoke of the inhaler of FIG. 1;

FIG. 14 is an enlarged isometric view of a dose counter of the inhaler of FIG.
1;
FIG. 15 is an exploded enlarged isometric view of the dose counter of the inhaler of FIG. 1; and FIG. 16 is an enlarged isometric view, partially in section, of a portion of the inhaler of FIG. 1 illustrating medicament inhalation through the inhaler.

Like reference characters designate identical or corresponding components and units throughout the several views.

Detailed Description of the Preferred Embodiments Referring to FIGS. 1 through 16, the present disclosure provides a new and iniproved ii-fllaler 10 for dispensiiig a dry-powdered medicament in metered doses for patient inhalation. The inhaler 10 of the present disclosure provides many beneficial features including but not limited to a dose metering system that dispenses dry powdered medicanient in discrete amounts or doses for patient inllalation, a medicament reservoir pressure system for managing pressure within the reservoir, and a dose counting system indicating the number of doses remaining in the iiilialer 10.

The ii-dlaler 10 generally includes a housing 18, and an asseinbly 12 received in the housing (see FIG. 2). The housing 18 includes a case 20 having an open end 22 and a mouthpiece 24 for patient inhalation, a cap 26 secured to and closing the open end 22 of the case 20, and a cover 28 pivotally mounted to the case 20 for covering the mouthpiece 24 (see FIGS. 1, 2 and 9). The housiiig 18 is preferably manufactured from a plastic such as polypropylene, acetal or moulded polystyrene, but may be manufactured from metal or aiother suitable material.

The internal assembly 12 includes a reservoir 14 for containing dry powered medicament in bulk form, a de-agglomerator 32 that brealcs down the rnedicanient between a delivery passageway 34 and the mouthpiece 24, and a spacer 38 connecting the reservoir to the de-agglomerator.
Reservoir The reservoir 14 is generally made up of a collapsible bellows 40 aud a hopper having an dispenser port 44 (see FIGS. 2-5 and 7-8) for dispensing medicament upon the bellows 40 being at least partially collapsed to reduce the internal voluine of the reservoir.
The hopper 42 is for holding the dry powder medicament in bulk form and has an open end 46 closed by the flexible accordion-like bellows 40 in a substantially air-tight manner.
An air filter 48 covers the open end 46 of the hopper 42 and prevents dry powder medicameiit froni lealcing from the hopper 42 (see FIG. 7).

S acer A base 50 of the hopper 42 is secured to a spacer 38, which is in turn secured to the de-agglomerator 32 (see FIGS. 3-5 and 7-8). The hopper 42, the spacer 38, and the de-agglomerator 32 are preferably manufactured from a plastic such as polypropylene, acetal or moulded polystyrene, but may be manufactured from metal or another suitable material.
The hopper 42, the spacer 38 and the de-agglomerator 32 are connected in a manner that provides ati air tiglit seal between the parts. For this purpose heat or cold sealing, laser welding or ultrasonic welding could be used, for example.

The spacer 38 and the hopper 42 togetller define the medicament delivery passageway 34, which preferably includes a venturi 36 (see FIG. 16) for creating an entraining air flow. The spacer 38 defines a slide channel 52 communicating with the dispenser port 44 of the hopper 42, and a chisnney 54 providing fluid communication between the medicament delivezy passageway 34 and a supply port 56 of the de-agglonlerator 32 (see FIGS. 7 and 8), The slide channel 52 extends generally normal with respect to the axis "A" of the inhaler 10.

De-A lomerator As its name implies, the de-agglomerator 32 brealts down agglomerates of dry powder medicament before the dry powder leaves the irllaler 10 throtigll the mouthpiece 24. The de-agglomerator includes a swirl cliamber 58 extending from the supply port 56 to an outlet port 60 aonnected to the mouthpiece 24 (see FIG. 16). The de-agglomerator 32 also includes two diametrically opposed inlet ports 62 that extend substantially tangential to the circular cross-section of the swirl chamber. Radial vanes 64 are positioned at the top of the swirl chamber and are sized such that at least a portion of breath-actuated air streams entering through the diametrically opposed inlet ports 62 collide with the vanes.

'It should be understood that although the inhaler 10 of the present disclosure is shown with a particular de-agglomerator 32, the inhaler 10 is not limited to use with the de-agglomerator shown and can be used with other types of de-agglomerators or a simple swirl chamber, Dose Meterinjz System The dose metering system includes a first yoke 66 and a second yoke 68 mounted on the uiternal assenibly 12 within the housing 18, and movable in a linear direction parallel with an axis "A" of the inhaler 10 (see FIG. 2). An actuation spring 69 is positioned between the cap 26 of the housing 18 and the first yolte 66 for biasing the yokes in a first direction towards the mouthpiece 24. In particular, the actuation spr.ulg 69 biases the first yolce 66 against the bellows 40 and the second yoke 68 against cams 70 mounted on the moutlipiece cover 28 (see FIG. 9).

The first yolce 66 includes an opening 72 that receives and retains a crown 74 of the bellows 40 such that the first yoke 66 pulls and expands the bellows 40 when moved towards the cap 26, i.e., against the actuation spring 69 (see FIG. 2). The second yoke 68 includes a belt 76, which receives the first yoke 66, and two cam followers 78 extending from the belt in a direction opposite the first yoke 66 (see FIGS. 3, 11 and 12), towards the cams 70 of the mouthpiece cover 28.

The dose metering system also uicludes the two cains 70 mounted on the mouthpiece cover 28 (see FIGS. 9 and 10), and movable with the cover 28 between open and closed positions. The canis 70 each include an opening 80 for allowing outwardly extending hinges 82 of the case 20 to pass tllerethrough and be received in first recesses 84 of the cover 28. The cams 70 also include bosses 86 extending outwardly and received in second recesses 88 of the cover 28, sucll that the cover 28 pivots about the hinges 82 and the cams 70 move witli the cover 28 about the hinges.

Each cam 70 also includes first, second arld third cam surfaces 90, 92, 94, and the cam followers 78 of the second yoke 68 are biased against the cam surfaces by the actuation spring 69. The cam surfaces 90, 92, 94 are ai.ranged such the cam followers 78 successively engage the first cam surfaces 90 when the cover 28 is closed, the second cam surfaces 92 when the cover 28 is partially opened, and the tliird cam surfaces 94 when the cover 28 is fully opened. The first cam surfaces 90' are spaced futther froin the hinges 82 than the second and the third cam surfaces, while the second cam surfaces 92 are spaced furtller from the hinges 82 than the third cain surfaces 94. The cams 70, therefore, allow the yolces 66, 68 to be moved by the actuation spring 69 parallel with the axis "A" of the iiihaler 10 in the first direction (towards the rnouthpiece 24) tlirough first, second and third positions as the cover 28 is opened. The cams 70 also push the yolces 66, 68 in a second direction parallel with the axis "A" (against the actuation spring 69 and towards the cap 26 of the housing 18) tlirough the third, the second and the first positions as the cover 28 is closed.
The dose metering system further includes a cup assembly 96 movable between the dispenser port 44 of the reservoir 14 and the delivery passageway 34. The cup assembly 96 includes a medicainent cup 98 mounted in a sled 100 slidably received in the slide chatmel 52 of the spacer 38 below the hopper 42 (see FIGS. 5 and 6). The medicament cup 98 includes a recess 102 adapted to receive medicament from the dispenser port 44 of the reservoir 14 and sized to hold a predetermined dose of dry powdered medicanient when filled. The cup sled 100 is biased along the slide channel 52 from the dispenser port 44 of the hopper 42 towards the delivery passageway 34 by a cup spring 104, which is secured on the hopper 42 (see FIGS. 4 and 5).

The dose metering system also includes a ratchet 106 and a push bar 108 on one of the cam followers 78 of the second yoke 68 that engage a boss 110 of the cup sled 100 (see FIGS. 5, 11 and 12). The ratchet 106 is mounted on a flexible flap 112 and is shaped to allow the boss 110 of the sled 100 to depress and pass over the ratchet 106, when the boss 110 is engaged by the push bar 108. Operation of the dose metering system is discussed below.

Reservoir Pressure System The reservoir pressure system includes a pressure relief conduit 114 in fluid communication with the interior of the reservoir 14 (see FIGS. 7 and 8), aiid a pressure relief port 116 in a wall of the slide cliaiuiel 52 (see FIGS. 5 and 8) providing fluid communication with the pressure relief conduit 114 of the hopper 42.

The medicament cup assembly 96 includes a first sealing surface 118 adapted to seal the dispenser port 44 upon the cup assembly being inoved to the delivery passageway 34 (see FIGS. 5 and 6). A sealing spring 120 is provided between the sled 100 and the cup 98 for biasing the medicament cup 98 against a bottom surface of the hopper 42 to seal the dispenser port 44 of the reservoir 14. The cup 98 includes clips 122 that allow the cup to be biased against the reservoir, yet retain the cup in the sled 100.

The sled 100 includes a second sealing surface 124 adapted to seal the pressure relief port 116 when the recess 102 of the cup 98 is aligned with the dispenser port 44, and an indentation 126 (see FIG. 6) adapted to unseal the pressure relief port 116 when the first sealing surface 118 is aligned with tlie dispenser port 44. Operation of the pressure system is discussed below.

Dose Counting Systein The dose counting system 16 is mounted to the hopper 42 and includes a ribbon 128, having suceessive numbers or other suitable indicia printed thereon, in alignment with a transparent window 130 provided in the housing 18 (see FIG. 2). The dose counting system 16 inch.ides a rotatable bobbin 132, an indexing spool 134 rotatable in a siiigle direction, and the ribbon 128 rolled and received on the bobbin 132 and having a first end 127 secured to the spool 134, wherein the ribbon 128 unrolls from the bobbin 132 so that the indicia is successively displayed as the spool 134 is rotated or advanced.

The spool 134 is arranged to rotate upon movement of the yokes 66, 68 to effect delivery of a dose of inedicament from the reservoir 14 into the delivery passageway 34, such that the number on the ribbon 128 is advanced to indicate that another dose has been dispensed by the inhaler 10. The ribbon 128 can be arrazged such that the numbers, or other suitable indicia, increase or decrease upon rotation of the spool 134.
For example, the ribbon 128 can be arranged such that the numbers, or other suitable indicia, decrease upon rotation of the spool 134 to indicate the number of doses remaining in the inhaler 10.
Alternatively, the ribbon 128 can be arranged such that the numbers, or other suitable indicia, increase upon rotation of the spoo1134 to indicate the number of doses dispensed by the inlialer 10.

The indexing spoo1134 preferably includes radially extending teeth 136, which are engaged by a pawl 138 extending from one of the cain followers 78 (see FIGS. 3 and 11) of the second yolce 68 upon movement of the yoke to rotate, or advance, the indexing spool 134. More particularly, the paw1138 is shaped and arranged such that it engages the teeth 136 and advances the indexing spool 134 only upon the moutlipiece 24 cover 28 being closed and the yokes 66, 68 moved back towards the cap 26 of the housing 18.

The dose counting system 16 also includes a chassis 140 that secures the dose counting system to the hopper 42 and includes shafts 142, 144 for receiving the bobbin 132 and the indexing spool 134. The bobbin shaft 142 is preferably forked and includes radially nubs 146 for creating a resilient resistance to rotation of the bobbin 132 on the shaft 142. A clutch spring 148 is received on the end of the indexing spool 134 and locked to the chassis 140 to allow rotation of the spool 134 in only a single direction (counter-clockwise as shown in FIG. 14). Operation of the dose counting system 16 is discussed below.

Operation FIG. 13 illustrates the relative movements of the boss 110 of the cup sled 100, and the ratehet 106 and the push bar 108 of the secoiid yoke 68 as the mouthpiece cover 28 is opened and closed. In the first position of the yokes 66, 68 (wherein the cover 28 is closed and the cain followers 78 are in contact with the first cam surfaces 90 of the cams 70), the ratchet 106 prevents the cup spring 104 from moving the cup sled 100 to the delivery passageway 34. The dose metering system is arranged such that when the yokes are in the first position, the recess 102 of the inedica.tnent cup 98 is directly aligned with the dispenser port 44 of the reservoir 14 and the pressure relief port 116 of the spacer 3 8 is sealed by the second sealing surface 124 of the cup sled 100.

Upon the cover 28 being partially opened such that the second cam surfaces 92 of the cams 70 engage the cam followers 78, the actuator spring 69 is allowed to move the yokes 66, 68 linearly towards the mouthpiece 24 to the second position and partially collapse the bellows 40 of the medicanient reservoir 14. The partially collapsed bellows 40 pressurizes the interior of the reservoir 14 and ensures medicanient dispensed from the dispenser port 44 of the reseivoir fills the recess 102 of the medicanient cup 98 such that a predetei-inined dose is provided. In the second position, however, the ratchet 106 prevents the cup sled 100 fiom being moved to the delivery passageway 34, such that the recess 102 of the medicanient cup 98 remains aligned with the dispenser port 44 of the reservoir 14 and the pressure relief port 116 of the spacer 38 remains sealed by the second sealing surface 124 of the cup asseinbly 96.

Upon the cover 28 being fully opened such that the third cam surfaces 94 engage the cam followers 78, the actuator spring 69 is allowed to move the yokes 66, 68 f-urther towards the mouthpiece 24 to the third position. When moved to the third position, the ratchet 106 disengages, or falls below the boss 110 of the cup sled 100 and allows the cup sled 100 to be moved by the cup spring 104, such that the filled recess 102 of the cup 98 is position in the venturi 36 of the delivery passageway 34 and the dispenser port 44 of the reservoir 14 is sealed by the first sealing surface 118 of the cup assembly 96. In addition, the pressure relief port 116 is tmcovered by the nidentation 126 in the side surface of the sled 100 to release pressure from the reservoir 14 and allow the bellows 40 to fiuther collapse and accomniodate the movement of the yokes 66, 68 to the third position. The inhaler 10 is then ready for iiilialation by a patient of the dose of inedicament placed in the delivery passageway 34.

As shown in FIG. 16, a breatll-induced air stream 150 diverted through the delivery passageway 34 passes through the venturi 36, entrains the medicament and carries the medicainent into the de-agglomerator 32 of the inhaler 10. Two other breath-induced air streams 152 (only one shown) enter the de-agglomerator 32 through the diametrically opposed inlet ports 62 and combine witll the medicanient entrained air stream 150 from the delivery passageway 34. The combined flows 154 and entrained dry powder medicament then travel to the outlet port 60 of the de-agglomerator and pass through the mouthpiece 24 for patient inhalation.

Once inlialation is completed, the moutlipiece cover 28 cal be closed. When the cover 28 is closed, the trigger cams 70 force the yokes 66, 68 upwardly such that the first yoke 66 expands the bellows 40, and the pawl 138 of the second yoke 68 advances the indexing spool 134 of the dose counting system 16 to provide a visual indication of a dose having been dispensed. In addition, the cup assembly 96 is forced baclc to the first position by the pusher bar 108 of the upwardly inoving second yoke 68 (see FIG. 13) such that the boss 110 of the cup sled 100 is engaged and retained by the ratcliet 106 of the second yoke 68.

It should be understood that the foregoing detailed description and preferred embodiment are only illustrative of inhalers constructed in accordance with the present disclosure. Various alternatives and modifications to the presently disclosed inllalers can be devised by those sltilled in the art without departing froin the spirit and scope of the present disclosure. For example, the medicanient cup could be provided on a rotary sled, advanced by movement of the yokes. In addition, the outlet port of the pressure relief could be provided in other locations than the side wall of the slide channel.
Furthermore, the dose counting system could be adapted to provide an audible indications in addition to a visual indication of a dispensed dose.

Claims (19)

CLAIMS:
1. A medicament inhaler comprising:

a mouthpiece for patient inhalation;

a cover moveable to open and close the mouthpiece;
a delivery passageway for directing an inhalation induced air flow through the mouthpiece;

a channel extending from the delivery passageway;
a reservoir for containing medicament, the reservoir having a dispensing port connected to the channel;

a cup received in the channel and movable between the dispensing port and the passageway;

a cup spring biasing the cup towards one of the dispensing port and the passageway; and a yoke movable between at least two positions and including a ratchet engaging the cup and preventing movement of the cup when the yoke is in one of the positions and allowing movement of the cup when the yoke is in another of the positions;

at least one moveable cam including three successive cam surfaces;

a spring biasing the yoke against the cam such that the movement of the cam causes the yoke to successively engage the cam surfaces and move the yoke between three positions wherein the ratchet is adapted to prevent movement of the cup to the passageway when the yoke is in two of the three positions and allow movement of the cup when the yoke is in a third of the three positions; and wherein the at least one moveable cam is secured to the cover for movement therewith, whereby opening and closing the mouthpiece causes the yoke to move between the three positions of the yoke.
2. An inhaler according to claim 1, wherein the cup spring biases the cup towards the delivery passageway.
3. An inhaler according to claim 2, wherein the yoke further includes a push bar adapted to return the cup to the dispensing port of the reservoir upon movement of the yoke to one of the positions.
4. An inhaler according to claim 3, further comprising:

at least one movable cam including at least two successive cam surfaces; and a spring biasing the yoke against the cam such that movement of the cam causes the yoke to successively engage the cam surfaces and move the yoke between the at least two positions of the yoke.
5. An inhaler according to claim 4, further comprising a cover movable to open and close the mouthpiece, wherein the at least one cam is secured to the cover for movement therewith, whereby opening and closing the mouthpiece causes the yoke to move between the three positions of the yoke.
6. An inhaler according to claim 4, wherein the cam is movable by rotation.
7. An inhaler according to claim 1, wherein the reservoir includes a volume of dry powdered medicament.
8. An inhaler according to claim 1, further comprising a de-agglomerator between the delivery passageway and the mouthpiece.
9. An inhaler according to claim 1, further comprising:

a pawl extending from the yoke;
a dose counter including, a bobbin, a rotatable spool, a rolled ribbon received on the bobbin and rotatable about an axis of the bobbin, the ribbon having indicia thereon successively extending between a first end of the ribbon secured to the spool and a second end of the ribbon positioned on the bobbin, and teeth extending radially outwardly from the spool into a predetermined path of the pawl during movement of the yoke between the at least two positions, so that the spool is rotated by the pawl and the ribbon is advanced onto the spool during movement of the cup.
10. An inhaler according to claim 1, wherein:
the channel includes a pressure relief port;

a conduit provides fluid communication between an interior of the reservoir and the pressure relief port; and the cup includes, a recess adapted to receive medicament when aligned with the dispensing port of the reservoir, a first sealing surface adapted to seal the dispensing port when the recess is unaligned with the dispensing port, and a second sealing surface adapted to seal the pressure relief port of the channel when the recess is aligned with the dispensing port and unseal the pressure relief port when the recess is unaligned with the dispensing port.
11. The medicament inhaler according to claim 1 further comprising:

a dose meter including a pawl movable along a predetermined path during the metering of a dose of medicament to the mouthpiece;

a dose counter including, a bobbin, a rotatable spool, a rolled ribbon received on the bobbin and rotatable about an axis of the bobbin, the ribbon having indicia thereon successively extending between a first end of the ribbon secured to the spool and a second end of the ribbon positioned on the bobbin, and teeth extending radially outwardly from the spool into the predetermined path of the pawl so that the spool is rotated by the pawl and the ribbon is advanced onto the spool during the metering of a dose.
12. The inhaler according to claim 11, wherein the spool rotates in a single direction.
13. The inhaler according to claim 11, wherein the dose counter includes a clutch spring secured to the spool and allowing rotation of the spool in a single direction.
14. The inhaler according to claim 11, wherein the indicia comprises numbers.
15. The inhaler according to claim 11, wherein the indicia are provided on a radially outwardly facing surface of the rolled ribbon.
16. The inhaler according to claim 11, wherein the predetermined path of the pawl is linear.
17. The inhaler according to claim 11, wherein the pawl moves in first and second directions along the predetermined path and is adapted to engage the teeth and advance the spool upon movement in the second direction.
18. The inhaler according to claim 11, further comprising a housing containing the dose counter and include a transparent window over the indicia of the ribbon.
19. The inhaler according to claim 11, wherein the indicia comprises numbers arranged to successively decrease as the ribbon is advanced onto the spool.
CA002552468A 2000-06-23 2001-06-23 Medicament inhaler Expired - Lifetime CA2552468C (en)

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US21338200P 2000-06-23 2000-06-23
US21366800P 2000-06-23 2000-06-23
US60/213,382 2000-06-23
US60/213,668 2000-06-23
CA002407262A CA2407262C (en) 2000-06-23 2001-06-23 Medicament inhaler

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