US20090308384A1 - Apparatus and methods for delivery of medicament to a respiratory system - Google Patents
Apparatus and methods for delivery of medicament to a respiratory system Download PDFInfo
- Publication number
- US20090308384A1 US20090308384A1 US12/583,256 US58325609A US2009308384A1 US 20090308384 A1 US20090308384 A1 US 20090308384A1 US 58325609 A US58325609 A US 58325609A US 2009308384 A1 US2009308384 A1 US 2009308384A1
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- reservoir
- medicament
- aerosol generator
- connector
- liquid medicament
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- 0 C**C(C*1C)C2=C1C(*)(C1C3CC(C**)C1)*1C=C3C(C(*)C(C)C)C(CC=CC(C)N)C1C2 Chemical compound C**C(C*1C)C2=C1C(*)(C1C3CC(C**)C1)*1C=C3C(C(*)C(C)C)C(CC=CC(C)N)C1C2 0.000 description 2
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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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
-
- 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
- A61M15/0085—Inhalators using ultrasonics
-
- 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
- A61M16/049—Mouthpieces
-
- 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
-
- 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8206—Internal energy supply devices battery-operated
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8262—Internal energy supply devices connectable to external power source, e.g. connecting to automobile battery through the cigarette lighter
-
- 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
- A61M2209/00—Ancillary equipment
- A61M2209/08—Supports for equipment
- A61M2209/082—Mounting brackets, arm supports for equipment
Definitions
- This invention relates to apparatus and methods for delivery of medicament to the respiratory system of a patient.
- the invention relates to apparatus and methods for use with a nebulizer.
- a nebulizer to create an aerosol of medication for delivery into the respiratory system of a patient.
- the medication is placed in a cup which is held over a reservoir of buffer water.
- a piezoelectric element is vibrated ultrasonically under the buffer water transferring energy to the water, thus causing an aerosol to be formed in the medication cup.
- Baffles are provided between the medication cup and the airway in an attempt to ensure large particles of medication rain out on the baffles and drip back down into the medication cup.
- nebulizers suffer from a number of disadvantages.
- medications have a range of different viscosities, but particle generation is not consistent across the range.
- the medication particle size is not accurately controlled and a broad range of particles pass into the patient airway.
- Impaction filters/baffles are often used to attempt to “rain-out” larger particles due to impact of the larger particles with the filters/baffles.
- Nebulized medication which rains out drips back into the cup only to be nebulized again. This impaction of the nebulized medication may degrade or destroy the medication, and this is particularly the case for long molecular structures, such as proteins.
- the medication in the cup is directly exposed to the airway. Therefore the nebulizer must be maintained substantially horizontal at all times to prevent medication spilling out into the patient airway. Also the ventilator pressure may be lost when the medication cup is removed to refill it.
- This method of aerosol generation requires a relatively large amount of energy.
- the response time of aerosol generation is therefore large.
- a considerable amount of heat is generated during use of the nebulizer, therefore to prevent patient discomfort or injury the nebulizer must be placed away from the patient.
- the generated heat degenerates the medication, which can be particularly harmful to protein based drugs.
- This invention is related to apparatus and methods for delivery of medicament to the respiratory system of a patient which overcome at least some of these disadvantages.
- an apparatus for delivery of a medicament to a respiratory system comprising a reservoir for a liquid medicament for delivery to a respiratory system, the reservoir having a liquid medicament inlet port and a medicament outlet; an aerosol generator at the medicament outlet of the reservoir for aerosolizing a liquid medicament; and a connector for entraining an aerosolized medicament from the aerosol generator with a gas.
- the inlet port is an upper inlet port and the outlet is a lower outlet for gravitational flow of a liquid medicament from the reservoir to the aerosol generator.
- the apparatus comprises a plug for selectively sealing the inlet port.
- the plug may be attached to the reservoir for movement between a sealed position and an open position.
- the plug is attached to the reservoir by an arm. The arm may be biased towards the open position.
- the arm defines a hinge for pivoting of the plug between the sealed position and the open position.
- the hinge may be a live hinge.
- the plug is integral with the arm.
- the arm is integral with at least part of the reservoir.
- the reservoir defines an access opening in a wall of the reservoir to facilitate access to an interior of the reservoir, and the reservoir comprises a cap for mounting at the access opening.
- the inlet port may be small relative to the access opening.
- the inlet port is provided through the cap.
- the plug is integral with the cap.
- the cap is mountable at the access opening in a snap-fit arrangement.
- the plug seals the inlet port in a snap-fit arrangement.
- An interior surface of the reservoir may be configured to promote flow of a liquid medicament towards the aerosol generator. Ideally the interior surface of the reservoir is inclined towards the aerosol generator.
- the reservoir may define a substantially conical shape at least in the region adjacent the aerosol generator.
- the connector comprises a gas conduit having an inlet and an outlet, and an aerosol supply conduit for delivering an aerosolized medicament from the aerosol generator into the gas conduit to entrain the aerosolized medicament with a gas.
- the aerosol supply conduit may subtend an angle of less than 90° with the inlet of the gas conduit. In one case the aerosol supply conduit subtends an angle of less than 80° with the inlet of the gas conduit. Ideally the aerosol supply conduit subtends an angle of about 75° with the inlet of the gas conduit.
- the aerosol supply conduit is co-axial with the inlet of the gas conduit.
- the inlet of the gas conduit may extend co-axially around the aerosol supply conduit.
- the aerosol supply conduit subtends an angle of 90° with the inlet of the gas conduit.
- the apparatus comprises a respiratory conduit for connecting the outlet of the gas conduit to a respiratory system.
- the respiratory conduit may be mounted to the connector at the outlet of the gas conduit.
- the respiratory conduit is releasably mounted to the connector at the outlet of the gas conduit.
- the respiratory conduit may be mounted to the connector by an interference fit between the respiratory conduit and the outlet of the gas conduit.
- the apparatus comprises an intermediate connector mounted between the respiratory conduit and the outlet of the gas conduit.
- the intermediate connector may have a lumen extending therethrough, and the cross-sectional area of the lumen may vary along the length of the lumen.
- the cross-sectional area of the lumen varies in a discontinuous manner along the length of the lumen.
- the respiratory conduit is mounted to the intermediate connector by an interference fit between the respiratory conduit and the intermediate connector.
- the intermediate connector is mounted to the outlet of the gas conduit by an interference fit between the intermediate connector and the outlet of the gas conduit.
- the intermediate connector comprises handle means for gripping the intermediate connector.
- the handle means may comprise one or more formations on the intermediate connector.
- the formation comprises a protruding flange.
- the handle means comprises two substantially diametrically opposed protruding flanges.
- the respiratory conduit is moveable relative to the gas conduit.
- the respiratory conduit is rotatable about the longitudinal axis of the outlet of the gas conduit.
- the respiratory conduit is selected from a group consisting of a mouthpiece, a face mask, and an inter-tracheal tube.
- the respiratory conduit may comprise an intermediate portion between the outlet of the gas conduit and the mouthpiece, or the face mask, or the inter-tracheal tube, the intermediate portion being moveable relative to the mouthpiece, or the face mask, or the inter-tracheal tube.
- the respiratory conduit defines a delivery path to a respiratory system, the delivery path being defined by a distance between the aerosol generator and the respiratory system, the delivery path having a length of less than about 500 mm.
- the respiratory conduit may have a delivery path of less than about 300 mm.
- the delivery path is substantially free of baffles and/or flow disrupters.
- the respiratory conduit includes a Y-shaped section which separates into a first arm for inhalation to a respiratory system and a second arm for exhalation from a respiratory system.
- the apparatus may comprise a ventilator conduit for connecting the inlet of the gas conduit to a ventilator.
- the ventilator conduit is mounted to the connector at the inlet of the gas conduit.
- the ventilator conduit is releasably mounted to the connector at the inlet of the gas conduit.
- the ventilator conduit may be mounted to the connector by an interference fit between the ventilator conduit and the inlet of the gas conduit.
- the apparatus comprises an intermediate connector mounted between the ventilator conduit and the inlet of the gas conduit.
- the intermediate connector may have a lumen extending therethrough, and the cross-sectional area of the lumen may vary along the length of the lumen.
- the cross-sectional area of the lumen varies in a discontinuous manner along the length of the lumen.
- the ventilator conduit is mounted to the intermediate connector by an interference fit between the ventilator conduit and the intermediate connector.
- the intermediate connector is mounted to the inlet of the gas conduit by an interference fit between the intermediate connector and the inlet of the gas conduit.
- the intermediate connector comprises handle means for gripping the intermediate connector.
- the handle means may comprise one or more formations on the intermediate connector.
- the formation comprises a protruding flange.
- the handle means comprises two substantially diametrically opposed protruding flanges.
- the apparatus comprises an aerosol generator housing in which the aerosol generator is held, and the connector is mounted to the aerosol generator housing.
- the connector may be releasably mounted to the aerosol generator housing.
- the connector is mounted to the aerosol generator housing by an interference fit between the aerosol generator housing and the aerosol supply conduit.
- the connector may be mounted to the aerosol generator housing by an interference fit between the aerosol generator housing and the inlet of the gas conduit.
- the aerosol generator housing is fixed to the reservoir.
- the aerosol generator housing may be integral with the reservoir.
- the apparatus comprises a signal interface to receive a control signal to control operation of the aerosol generator.
- the apparatus may comprise a controller to control operation of the aerosol generator, the controller being connectable to the signal interface.
- the controller has an on-board power source.
- the controller may comprise a power connector, the power connector being connectable to a remote power source.
- the controller comprises a timer to automatically switch the aerosol generator between an active state and a rest state.
- the timer may be selectively programmable.
- the controller ideally comprises a user interface to selectively control operation of the aerosol generator.
- the user interface may be remote from the aerosol generator housing.
- the controller comprises status indication means to indicate the operational state of the aerosol generator.
- the status indication means comprises at least one visual indicator.
- the controller comprises a housing having a support to receive a mounting device.
- the support may comprise a recess in the housing for receiving a mounting device.
- the support comprises at least one ledge overhanging the recess for engagement of a mounting device in the recess.
- the support may comprise two ledges on opposite sides of the recess.
- the apparatus comprises a mounting device to support the controller.
- the mounting device may comprise means for attaching the mounting device to a support; and hook means for supporting the housing, the hook means being configured to define a plurality of support surfaces for supporting the housing in an upright configuration.
- the support surfaces each comprise a lip protruding from a main body of the mounting device. The lip may be engagable in the recess in the housing to support the controller.
- the hook means defines four support surfaces. Each support surface may be substantially perpendicular to an adjacent support surface.
- the attachment means is releasable.
- the attachment means comprises a clamp.
- the hook means is movable relative to the attachment means to selectively disassociate the hook means from the attachment means.
- the attachment means may define a groove in which the hook means is slidable to selectively disassociate the hook means from the attachment means.
- the aerosol generator comprises a vibratable member having a plurality of apertures extending between a first surface and a second surface thereof.
- the first surface may be adapted to receive a liquid medicament from the reservoir.
- the aerosol generator is configured to generate an aerosol at the second surface.
- the vibratable member is dome shaped in geometry.
- the vibratable member may comprise a piezoelectric element.
- the apertures in the vibratable member are sized to aerosolize the medicament by ejecting droplets of medicament such that about 70% or more of the droplets by weight have a size in the range from about 1 to about 5 micrometers.
- kits for delivery of a medicament to a respiratory system comprising an apparatus of the invention; and a supply container for delivering a liquid medicament through the inlet port into the reservoir.
- the supply container defines a delivery tip configured to mate with the inlet port of the reservoir for delivering a liquid medicament through the inlet port into the reservoir.
- the delivery tip may be configured for insertion at least partially through the inlet port.
- the supply container has indication means to indicate the volume of liquid medicament delivered into the reservoir.
- the indication means may be provided by at least one marking on the supply container.
- the supply container comprises a nebule. In another case the supply container comprises a syringe.
- the invention provides a connector for entraining an aerosolized medicament with a gas to deliver the medicament to a respiratory system, the connector comprising a gas conduit having an inlet and an outlet; and an aerosol supply conduit for delivering an aerosolized medicament into the gas conduit to entrain the aerosolized medicament with a gas, the connector comprising a cap to selectively seal the aerosol supply conduit to maintain the pressure in the gas conduit when the connector is not in use.
- the cap is attached to the gas conduit.
- a method of delivering a medicament to a respiratory system comprising the steps of providing a reservoir for a liquid medicament to be delivered to a respiratory system; delivering a volume of the liquid medicament into the reservoir; providing an aerosol generator for aerosolizing the liquid medicament; arranging the aerosol generator beneath the reservoir for gravitational flow of the liquid medicament from the reservoir to the aerosol generator; aerosolizing the liquid medicament; delivering the aerosolized medicament to the respiratory system.
- the method comprises the step of entraining the aerosolized medicament with a gas before delivering the aerosolized medicament to the respiratory system.
- the aerosol generator may be mounted to the reservoir beneath the reservoir.
- the method comprises the step of vibrating at least part of the aerosol generator to aerosolize the liquid medicament.
- the method comprises the step of delivering a further volume of the liquid medicament into the reservoir.
- the further volume of the liquid medicament may be delivered into the reservoir after all of the liquid medicament in the reservoir has been aerosolized.
- the further volume of the liquid medicament may be delivered into the reservoir before all of the liquid medicament in the reservoir has been aerosolized.
- the method comprises the step of opening a port to deliver the volume of the liquid medicament through the port into the reservoir.
- the method may comprise the step of sealing the port after delivering the volume of the liquid medicament into the reservoir. Ideally the port is sealed before the step of aerosolizing the liquid medicament.
- the inlet port to the reservoir is distanced from the aerosol generator to create a sterile barrier between the carrier delivering the liquid medicament into the reservoir and the respiratory system of the patient.
- the liquid medicament flows by gravitational action from the reservoir to the aerosol generator.
- This arrangement provides a simple, consistent means of delivering liquid medicament to the aerosol generator, regardless of the viscosity of the liquid medicament.
- the reservoir is configured to promote flow of the liquid medicament towards the aerosol generator. This arrangement minimizes the residual volume of the liquid medicament remaining in the reservoir after use, and also enables the volume of the liquid medicament delivered to the respiratory system of the patient to be accurately controlled.
- the reservoir may be quickly and easily filled or refilled without requiring dismounting of any parts of the assembled apparatus.
- the apparatus of the invention may be quickly and easily cleaned, for example by autoclaving.
- the cap may be removed from the relatively large access opening to facilitate cleaning of the interior of the reservoir through the access opening, and also to facilitate egress of material and/or cleaning fluids out of the reservoir through the access opening.
- FIG. 1 is a side, cross-sectional view of an apparatus for delivery of a medicament to a respiratory system according to the invention
- FIG. 2 is an exploded, perspective view of the apparatus of FIG. 1 ;
- FIG. 3 is a perspective view of a cap of the apparatus of FIGS. 1 and 2 ;
- FIG. 4 is a perspective view of the cap of FIG. 3 mounted to a reservoir of the apparatus of FIGS. 1 and 2 ;
- FIGS. 5 and 6 are perspective views illustrating filling of the reservoir of FIG. 4 through the cap;
- FIG. 7 is a perspective view of a controller of the apparatus of FIGS. 1 and 2 ;
- FIG. 8 is a perspective view of an alternative connector of the apparatus of FIGS. 1 and 2 ;
- FIG. 9 is a perspective view from beneath of the connector of FIG. 8 mounted to an aerosol generator housing of the apparatus of FIGS. 1 and 2 ;
- FIG. 10 is a side view of the apparatus of FIG. 9 in use mounted to a face mask
- FIG. 11 is a side view of the apparatus of FIG. 9 in use mounted to a mouthpiece;
- FIG. 12 is a perspective view of the mouthpiece of FIG. 11 ;
- FIG. 13 is a side view of the apparatus of FIG. 9 in use mounted to an inter-tracheal tube;
- FIG. 14 is a perspective view of the apparatus of FIG. 9 in use in a breathing circuit
- FIG. 15 is a perspective view of the connector of FIG. 8 with a cap sealing an aerosol supply conduit of the connector;
- FIG. 16 is a perspective view of the cap of FIG. 15 ;
- FIG. 17 is a perspective view of the connector of the apparatus of FIGS. 1 and 2 with the cap of FIG. 16 sealing an aerosol supply conduit of the connector;
- FIG. 17( a ) is a perspective view of another alternative connector of the apparatus of FIGS. 1 and 2 ;
- FIG. 17( b ) is a cross-sectional view along line XVII-XVII in FIG. 17( a );
- FIG. 17( c ) is a perspective view of the connector of FIG. 17( a ) in a breathing circuit
- FIG. 17( d ) is a perspective view of an upstream intermediate connector of the apparatus of the invention.
- FIG. 17( e ) is a cross-sectional view along line XVIII-XVIII in FIG. 17( d );
- FIG. 17( f ) is a perspective view of a downstream intermediate connector of the apparatus of the invention.
- FIG. 17( g ) is a cross-sectional view along line XIX-XIX in FIG. 17( f );
- FIG. 17( h ) is a perspective view illustrating mounting of the intermediate connectors of FIGS. 17( d ) to 17 ( g ) to the connector of FIG. 17( a );
- FIG. 17( i ) is a perspective view of the intermediate connectors of FIGS. 17( d ) to 17 ( g ) and the connector of FIG. 17( a ) in a breathing circuit;
- FIG. 17( j ) is a perspective view of another upstream intermediate connector of the apparatus of the invention.
- FIG. 17( k ) is a perspective view of another downstream intermediate connector of the apparatus of the invention.
- FIG. 17( m ) is a perspective view illustrating mounting of the intermediate connectors of FIGS. 17( j ) and 17 ( k ) to the connector of FIG. 17( a );
- FIGS. 18 to 20 are flow diagrams illustrating operational arrangements for using the apparatus
- FIG. 21 is a plan view of a rear side of the controller of FIG. 7 ;
- FIG. 22 is a perspective view along the rear side of the controller of FIG. 21 ;
- FIG. 23 is a perspective view of a mounting device
- FIGS. 24 and 25 are perspective views of the mounting device of FIG. 23 supporting the controller of FIG. 21 ;
- FIG. 26 is an exploded, perspective view of another mounting device in use with the controller of FIG. 21 ;
- FIG. 27 is a side view of the apparatus of FIG. 9 in use with the controller of FIG. 21 and the mounting device of FIG. 26 .
- FIGS. 1 to 7 there is illustrated an apparatus 1 according to the invention for delivering a medicament to a respiratory system.
- the apparatus 1 comprises a reservoir 2 for a liquid medicament for delivery to a respiratory system, an aerosol generator 3 for aerosolizing the liquid medicament, and a connector 6 for entraining the aerosolized medicament from the aerosol generator 3 with a gas.
- the reservoir 2 comprises a lower portion 7 and an upper portion 8 , as illustrated in FIGS. 1 and 2 , the two portions 7 , 8 being fixed together.
- the two portions 7 , 8 are injection moulded separately, and are then ultrasonically welded together to form the reservoir 2 .
- the portions 7 , 8 could be integrally manufactured, such as by a CNC machining process.
- An access opening 9 is defined in a wall of the upper portion 8 of the reservoir 2 ( FIG. 2 ), the opening 9 facilitating access to the interior of the reservoir 2 , for example for cleaning the interior of the reservoir 2 .
- the reservoir 2 comprises a cap 10 for mounting at the access opening 9 to close the opening 9 when the apparatus 1 is in use ( FIG. 1 ).
- the cap 10 may define a suitable projecting annular lip 15 for snap-fit mounting of the cap 10 at the opening 9 .
- the reservoir 2 has an upper liquid medicament inlet port 11 for delivering the liquid medicament into the reservoir 2 .
- the inlet port 11 which is small relative to the access opening 9 , is provided through the cap 10 , as illustrated in FIG. 1 .
- a plug 12 is provided to seal the inlet port 11 , the plug 12 being attached to the cap 10 by an arm 13 for movement of the plug 12 between a sealed position ( FIG. 6 ) and an open position ( FIG. 5 ).
- the arm 13 includes a hinge for pivoting of the plug 12 between the sealed position and the open position, preferably the hinge is a live hinge to bias the arm 13 towards the open position.
- a suitable projecting annular shoulder 14 may be provided on the plug 12 for snap-fit sealing of the inlet port 11 by the plug 12 .
- the cap 10 , arm 13 and plug 12 may be integrally formed of a polymeric material in a molding process.
- a polymeric material is a silicone material with a Shore A hardness of between 60 and 80.
- the reservoir 2 has a lower medicament outlet 16 , and the aerosol generator 3 is positioned, when the apparatus 1 is assembled, at the outlet 16 ( FIG. 1 ). In use, the liquid medicament flows by gravitational action from the reservoir 2 to the aerosol generator 3 .
- the lower portion 7 of the reservoir 2 is substantially conical shaped, sloping towards the aerosol generator 3 to promote flow of the liquid medicament towards the aerosol generator 3 at the outlet 16 (Flow G), as illustrated in FIG. 1 . In this manner, the residual volume of the liquid medicament that remains in the reservoir 2 after use is minimised, and thus the volume of the liquid medicament which is delivered to the respiratory system of the patient is accurately controlled.
- a typical volume of liquid medicament that can be held in the reservoir is 10 mL, or 6 mL.
- the aerosol generator 3 comprises a vibratable member 40 and a piezoelectric element 42 .
- the vibratable member 40 has a plurality of tapered apertures extending between a first surface and a second surface thereof, as described in U.S. Pat. No. 5,164,740, U.S. Pat. No. 5,586,550, U.S. Pat. No. 5,758,637, U.S. Pat. No. 6,085,740, the entire contents of which are incorporated herein by reference.
- the first surface of the vibratable member 40 which in use faces upwardly, receives the liquid medicament from the reservoir 2 , and the aerosolised medicament is generated at the second surface of the vibratable member 40 by ejecting droplets of medicament upon vibration of the member 40 .
- the second surface faces downwardly.
- the apertures in the vibratable member 40 may be sized to produce an aerosol in which about 70% or more of the droplets by weight have a size in the range from about 1 to 5 micrometers.
- the vibratable member 40 is non-planar, and is preferably dome-shaped in geometry.
- the apparatus 1 comprises an aerosol generator housing 4 fixed to the lower portion 7 of the reservoir 2 , for example by integrally manufacturing the housing 4 and the lower portion 7 .
- the aerosol generator 3 is held within the aerosol generator housing 4 between an upper shield 41 and a lower retainer 44 .
- the shield 41 , the piezoelectric element 42 , and the retainer 44 have central apertures aligned to facilitate flow of the liquid medicament from the reservoir 2 to the aerosol generator 3 , and to facilitate passage of the aerosolized medicament from the aerosol generator 3 into a neck 30 of the aerosol generator housing 4 .
- An O-ring seal 46 and a sleeve 45 are provided between the retainer 44 and the wall of the aerosol generator housing 4 and the shield 41 is fixed to the lower portion 7 of the reservoir 2 .
- An anti-bacterial coating may be applied to the vibratable member 40 to ensure a sterile flow of aerosolized medicament into the neck 30 .
- the connector 6 comprises a gas conduit having an inlet 61 and an outlet 62 , and an aerosol supply conduit 60 for delivering the aerosolised medicament from the aerosol generator 3 into the gas conduit to entrain the aerosolised medicament with a gas, such as air, passing through the gas conduit.
- a gas such as air
- the connector 6 is of a general T-shape, the aerosol supply conduit 60 subtending an angle of about 75° with the inlet 61 of the gas conduit ( FIG. 1 ).
- the longitudinal axis of the inlet 61 of the gas conduit is co-axial with the longitudinal axis of the outlet 62 of the gas conduit, and the gas conduit tapers slightly outwardly between the inlet 61 and the outlet 62 .
- the angle subtended between the aerosol supply conduit 60 and the inlet 61 of the gas conduit may be any suitable angle in the range of from 60° to 90°, but preferably less than 90°, and most preferably from 60° to 80°, to induce the entrained aerosolized medicament/gas mixture to pass out of the gas conduit through the outlet 62 , in particular when the apparatus 1 is used in a floor use non-ventilator application.
- the aerosol supply conduit 60 and the gas conduit meet at a junction 63 ( FIG. 1 ).
- the aerosol supply conduit 60 of the connector 6 is releasably mounted to the neck 30 of the aerosol generator housing 4 by means of a push-fit arrangement. This enables the connector 6 to be easily dismounted from the aerosol generator housing 4 , for example for cleaning.
- the neck 30 at least partially lines the interior of the aerosol supply conduit 60 , as illustrated in FIG. 1 .
- the inlet 61 of the gas conduit may be connected to a ventilator 70 which pumps a gas, such as air, into the gas conduit, alternatively the apparatus 1 may be employed during manual breathing with the inlet 61 of the gas conduit being open to atmosphere.
- a ventilator 70 which pumps a gas, such as air, into the gas conduit
- the apparatus 1 may be employed during manual breathing with the inlet 61 of the gas conduit being open to atmosphere.
- the apparatus 1 also includes a controller 50 as illustrated in FIG. 7 , to control operation of and to supply power to the aerosol generator 3 .
- the reservoir 2 has a signal interface port 38 fixed to the lower portion 7 of the reservoir 2 to receive a control signal from the controller 50 .
- the controller 50 may be connected to the signal interface port 38 by means of a control lead 52 which has a docking member 51 for mating with the port 38 .
- a control signal and power may be passed from the controller 50 through the lead 52 and the port 38 to the aerosol generator 3 to control the operation of the aerosol generator 3 and to supply power to the aerosol generator 3 respectively.
- the power source for the controller 50 may be an on-board power source, such as a rechargeable battery, or a remote power source, such as a mains power source, or a ventilator power source.
- a remote power source such as a mains power source, or a ventilator power source.
- an AC-DC converter may be connected between the AC power source and the controller 50 .
- a power connection lead may be provided to connect a power socket 53 of the controller 50 with the remote power source.
- the controller 50 has a housing 57 , and a user interface to selectively control operation of the aerosol generator 3 .
- the user interface is provided on the housing 57 which, in use, is located remote from the aerosol generator housing 4 .
- the user interface may be in the form of, for example, an on-off button 54 , or a reset button.
- a selectively programmable timer may be provided by the controller 50 to automatically switch the aerosol generator 3 between an active state and a rest state.
- the timer may be configured to switch the aerosol generator 3 from an active state to a rest state after 15 minutes of aerosol generation.
- the timer may alternatively be configured to activate generation of the aerosol a short period after commencement of an inhalation cycle, for example within 20 milliseconds, and to cease generation of the aerosol a short period after commencement of an exhalation cycle, for example within 20 milliseconds.
- Status indication means are also provided on the housing 57 to indicate the operational state of the aerosol generator 3 .
- the status indication means may be in the form of two visible LED's, with one LED 55 being used to indicate a 15 minute timer cycle, and the other LED 56 being used to indicate a 30 minute timer cycle.
- one LED 55 may be used to indicate an operational state of the aerosol generator 3
- the other LED 56 may be used to indicate a rest state of the aerosol generator 3 .
- a fault indicator 58 is also provided in the form of an LED on the housing 57 .
- a battery charge indicator 59 in the form of an LED is provided at the side of the housing 57 .
- the cap 10 is mounted at the access opening 9 in a snap-fit manner to close the opening 9 .
- the plug 12 is then moved from the sealed position ( FIG. 6 ) to the open position ( FIG. 5 ) by hinging the arm 13 to the open position, and a volume of liquid medicament is delivered through the inlet port 11 into the reservoir 2 .
- a supply container such as a nebule 20 ( FIG. 5 ) or a syringe, is used to deliver the liquid medicament through the inlet port 11 into the reservoir 2 .
- a delivery tip 21 is defined at an end of nebule 20 for mating with the inlet port 11 by inserting the delivery tip 21 at least partially through the inlet port 11 .
- the volume of liquid medicament may be easily and quickly delivered into the reservoir 2 .
- the arm 13 When the desired volume of liquid medicament has been delivered into the reservoir 2 , the arm 13 is hinged to the closed position and the inlet port 11 is sealed by the plug 12 ( FIG. 6 ).
- the nebule 20 preferably includes markings to indicate the volume of liquid medicament delivered into the reservoir 2 . This provides an accurate means of measuring the volume of liquid medicament being delivered to the respiratory system of a patient.
- this arrangement creates a sterile barrier between the carrier delivering the liquid medicament into the reservoir 2 and the respiratory system of the patient.
- the liquid medicament in the reservoir 2 flows by gravitational action towards the aerosol generator 3 at the lower medicament outlet 16 (Flow G).
- the connector 6 is then releasably mounted to the aerosol generator housing 4 at the aerosol supply conduit 60 by means of an interference fit between the neck 30 of the aerosol generator housing 4 and the aerosol supply conduit 60 of the connector 6 ( FIG. 1 ).
- the docking member 51 of the control lead 52 is mated with the signal interface port 38 on the reservoir 2 to connect the controller 50 to the aerosol generator 3 .
- the controller 50 may then be activated to supply power and a control signal to the aerosol generator 3 , which causes the piezoelectric element 42 to vibrate the non-planar member 40 .
- This vibration of the non-planar member 40 causes the liquid medicament at the top surface of the member 40 to pass through the apertures to the lower surface where the medicament is aerosolized by the ejection of small droplets of medicament.
- the aerosolized medicament passes from the aerosol generator 3 into the neck 30 of the aerosol generator housing 4 (Flow A), which is mounted within the aerosol supply conduit 60 of the connector 6 , and into the gas conduit of the connector 6 (Flow B).
- the aerosolized medicament is entrained in the gas conduit with a gas, such as air, which passes into the gas conduit through the inlet 61 (Flow C).
- the entrained mixture of the aerosolized medicament and the gas then passes out of the gas conduit through the outlet 62 (Flow D) and on to the respiratory system of the patient.
- the reservoir 2 may be quickly and easily refilled by opening the seal at the inlet port 11 and delivering liquid medicament through the inlet port 11 into the reservoir 2 , as described previously with reference to FIGS. 5 and 6 . It is not necessary to dismount any parts of the apparatus 1 during refilling of the reservoir 2 .
- the generation of aerosolized medicament at the aerosol generator 3 may continue during refilling, or alternatively the generation may be temporarily stopped during refilling.
- the refill arrangement of the reservoir 2 enables the apparatus 1 to be reused many times.
- a suitable material for the connector 6 , and for the integral reservoir 2 and aerosol generator housing 4 is polysulphone. By manufacturing these components of the apparatus from polysulphone, this enables these components to be autoclaved for multiple use of the same apparatus.
- the connector 6 , the reservoir 2 and the aerosol generator housing 4 are suitable to be autoclaved up to 100 times.
- An alternative material for the connector 6 , and for the integral reservoir 2 and aerosol generator housing 4 is polycarbonate. This reduces the component cost, however the number of times these components can be autoclaved and re-used is also reduced by using polycarbonate.
- FIGS. 8 and 9 there is illustrated another connector 64 , which is similar to the connector 6 of FIGS. 1 and 2 , and similar elements in FIGS. 8 and 9 are assigned the same reference numerals.
- the connector 64 may be substituted for the connector 6 , and thereafter operation of the apparatus 1 of the invention using the connector 64 proceeds in a manner similar to that described previously with reference to FIGS. 1 to 7 .
- the gas conduit of the connector 64 has a smaller diameter and is longer than the gas conduit of the connector 6 of FIGS. 1 and 2 .
- a respiratory conduit such as a face mask 50 to assist breathing of a patient ( FIG. 10 ), or a mouthpiece 51 ( FIGS. 11 and 12 ), or an inter-tracheal tube 52 ( FIG. 13 ) may be provided to connect the outlet 62 of the gas conduit with the respiratory system of the patient.
- the respiratory conduit 50 , 51 , 52 may be mounted to the connector 64 at the outlet 62 of the gas conduit in a releasable manner, for example by means of an interference fit between the respiratory conduit 50 , 51 , 52 and the outlet 62 of the gas conduit ( FIGS. 10 , 11 , 13 ).
- the apparatus 1 is lightweight. By mounting the apparatus 1 to the face mask 50 which may be worn by a patient, the apparatus 1 may be used during movement of the patient. During such movement, the apparatus 1 is supported by the face mask 50 due to the interference fit between the face mask 50 and the outlet 62 of the gas conduit, the face mask 50 being in turn held in place on the patient by means of straps.
- the delivery path between the aerosol generator 3 and the respiratory system of the patient may be 500 mm or shorter, for example approximately 300 mm. No baffles or flow disrupters are provided along the delivery path.
- a ventilator conduit 53 may be provided to connect a ventilator to the inlet 61 of the gas conduit.
- the ventilator conduit 53 may be mounted to the connector 64 at the inlet 61 of the gas conduit in a releasable manner, for example by means of an interference fit between the ventilator conduit 53 and the inlet 61 of the gas conduit ( FIG. 14 ).
- the ventilator can be used to pump air, or oxygen, or any other suitable gas or gas mixture into the inlet 61 of the gas conduit.
- FIG. 14 illustrates the assembled apparatus 1 of the invention with the ventilator conduit 53 mounted to the inlet 61 of the gas conduit, and the respiratory conduit mounted to the outlet 62 of the gas conduit.
- the respiratory conduit includes a Y-shaped section 54 which separates into a first arm 55 for inhalation to the respiratory system of the patient (Flow E) and a second arm 56 for exhalation from the respiratory system (Flow F).
- any of the face mask 50 , or the mouthpiece 51 , or the inter-tracheal tube 52 may be provided between the first arm 55 and the respiratory system.
- a ventilator pumps a gas, such as air, through the ventilator conduit 53 into the inlet 61 of the gas conduit (Flow E).
- the generated aerosol of medicament passes from the aerosol generator 3 through the neck 30 of the aerosol generator housing 4 , which lines the aerosol supply conduit 60 of the connector 64 , and into the gas conduit of the connector 64 .
- the aerosolized medicament is entrained with the air in the gas conduit, and the entrained mixture passes out of the gas conduit through the outlet 62 and into an inlet tube 157 of the Y-shaped section 54 .
- the entrained mixture then passes through the first arm 55 to the respiratory system of the patient (Flow E).
- the exhaled gases pass from the respiratory system through the first arm 55 , on through the second arm 56 to the atmosphere (Flow F).
- Y-shaped section 54 may be provided upstream of the apparatus 1 in the ventilator circuit.
- a capping device 70 may be provided for the connector 64 to selectively seal the aerosol supply conduit 60 , as illustrated in FIGS. 15 and 16 .
- the capping device 70 comprises an insertion plug 71 connected to a mounting ring 73 by an arm 72 .
- the ring 73 is usually mounted around the gas conduit ( FIG. 15 ).
- the capping device 70 may be used to seal the aerosol supply conduit 60 by inserting the plug 71 into the aerosol supply conduit 60 when the aerosol generator housing 4 is dismounted from the connector 64 , as illustrated in FIG. 15 .
- This ensures that the pressure in the gas conduit is maintained when the aerosol generator housing 4 has been dismounted. This is particularly advantageous when the connector 64 is connected in position in a ventilator circuit, as illustrated in FIG. 14 , in which case the pressure in the ventilator circuit will be maintained by the capping device 70 when the aerosol generator housing 4 has been dismounted from the connector 64 .
- a tab 74 on the plug 71 enables ease of removal of the plug 71 from within the aerosol supply conduit 60 .
- the capping device 70 may simply hang from the ring 73 mounted around the gas conduit.
- the capping device 70 is also suitable for use with the connector 6 , as illustrated in FIG. 17 .
- capping device 70 may be used to seal any suitable part of a pressure circuit.
- FIGS. 17( a ) to 17 ( c ) there is illustrated another connector 300 , which is similar to the connector 6 of FIGS. 1 and 2 , and similar elements in FIGS. 17( a ) and 17 ( b ) are assigned the same reference numerals.
- the aerosol supply conduit 60 is substantially perpendicular to the gas conduit, the aerosol supply conduit 60 subtending an angle of approximately 90° with the inlet 61 of the gas conduit ( FIG. 17( b )).
- the gas conduit of the connector 300 has a substantially smaller diameter, for example approximately 15 mm, than the gas conduit of the connector 6 of FIGS. 1 and 2 .
- the connector 300 is thus particularly suitable for use in a pediatric care application.
- the diameter of the aerosol supply conduit 60 is the same for both the connector 300 and the connector 6 of FIGS. 1 and 2 .
- a suitable diameter for the aerosol supply conduit 60 may be, as an example, approximately 22 mm.
- FIG. 17( c ) illustrates the apparatus of the invention with a small diameter pediatric ventilator conduit 353 releasably mounted to the connector 300 at the inlet 61 of the gas conduit by means of an interference fit between the male ventilator conduit 353 and the female inlet part 61 .
- a small diameter pediatric Y-shaped respiratory section 354 is releasably mounted to the connector 300 at the outlet 62 of the gas conduit by means of an interference fit between the female inlet tube 157 of the Y-shaped section 354 and the male outlet part 62 .
- the Y-shaped section 354 separates into a first arm 55 for inhalation to the respiratory system of the patient (Flow E) and a second arm 56 for exhalation from the respiratory system (Flow F).
- the pediatric apparatus of FIG. 17( c ) operates in a manner similar to that described previously with reference to FIG. 14 .
- FIGS. 17( d ) and 17 ( e ) illustrate an upstream intermediate connector 400 having an upstream end 402 and a downstream end 403 .
- a lumen 406 extends through the intermediate connector 400 from the upstream end 402 to the downstream end 403 .
- the cross-sectional area of the lumen 406 increases along the length of the intermediate connector 400 from the upstream end 402 to the downstream end 403 in a discontinuous fashion at an elbow 408 .
- FIGS. 17( f ) and 17 ( g ) there is illustrated a downstream intermediate connector 401 having an upstream end 404 and a downstream end 405 .
- a lumen 407 extends through the intermediate connector 401 from the upstream end 404 to the downstream end 405 .
- the cross-sectional area of the lumen 407 decreases along the length of the intermediate connector 401 from the upstream end 404 to the downstream end 405 in a discontinuous fashion at two elbows 409 , 410 .
- the upstream intermediate connector 400 may be releasably mounted to the inlet 61 of the gas conduit of the connector 300 by means of an interference fit between the female inlet part 61 and the male downstream end 403 of the intermediate connector 400 ( FIG. 17( h )).
- the downstream intermediate connector 401 may be releasably mounted to the outlet 62 of the gas conduit of the connector 300 by means of an interference fit between the female upstream end 404 of the intermediate connector 401 and the male outlet part 62 ( FIG. 17( h )).
- a very small diameter for example approximately 7.5 mm, neo-natal ventilator conduit 420 may then be releasably mounted to the upstream end 402 of the upstream intermediate connector 400 by means of an interference fit between the female upstream end 402 of the upstream intermediate connector 400 and the male ventilator conduit 420 .
- a very small diameter for example approximately 7.5 mm, neo-natal bifurcated, i.e.
- Y-shaped, respiratory section 421 may be releasably mounted to the downstream end 405 of the downstream intermediate connector 401 by means of an interference fit between the male inlet tube 157 of the Y-shaped section 421 and the female downstream end 405 of the downstream intermediate connector 401 .
- the intermediate connectors 400 , 401 may be used to facilitate assembly of the connector 300 within a neo-natal breathing circuit, as illustrated in FIG. 17( i ).
- the upstream intermediate connector 400 provides a step-up in the cross-sectional area of the flow from the smaller diameter neo-natal ventilator conduit 420 to the larger diameter gas conduit of the connector 300 .
- the downstream intermediate connector 401 provides a step-down in the cross-sectional area of the flow from the larger diameter gas conduit of the connector 300 to the smaller diameter neo-natal Y-shaped respiratory section 421 .
- the Y-shaped section 421 separates into a first arm 55 for inhalation to the respiratory system of the patient (Flow E) and a second arm 56 for exhalation from the respiratory system (Flow F). Operation of the neo-natal apparatus of FIG. 17( i ) operates in a manner similar to that described previously with reference to FIG. 14 .
- the intermediate connectors 400 , 401 provide a bridging means between the connector 300 and the ventilator conduit 420 and the Y-shaped section 421 , so that a single connector 300 may be used for both pediatric care applications ( FIG. 17( c )) and neo-natal care applications ( FIG. 17( i )).
- the upstream intermediate connector 430 of FIG. 17( j ) has two diametrically opposed protruding flanges 431 on the elbow 408 of the intermediate connector 430 .
- the downstream intermediate connector 432 of FIG. 17( k ) has two diametrically opposed protruding flanges 431 on the elbow 409 of the intermediate connector 432 .
- the flanges 431 provide a handle means for gripping the intermediate connectors 430 , 432 to assist mounting and demounting of the intermediate connectors 430 , 432 to the connector 300 , as illustrated in FIG. 17( m ). This feature may be applied to any of the connectors.
- FIGS. 18 to 20 there are illustrated some possible arrangements for using the apparatus 1 , according to the invention, for delivering medicament to a respiratory system 203 of a patient.
- gas is pumped from a ventilator 200 into the inlet 61 of the gas conduit (line G).
- the power source for the controller 50 which controls operation of the apparatus 1 is provided by the ventilator 200 (line P).
- gas is pumped from the ventilator 200 into the inlet 61 of the gas conduit (line G).
- the power source for the controller 50 is provided by a battery 201 and/or a mains power source 202 (lines P).
- gas is drawn into the inlet 61 of the gas conduit directly from the atmosphere 204 (line G).
- the power source for the controller 50 is provided by the battery 201 and/or the mains power source 202 and/or the ventilator 200 (lines P).
- the apparatus 1 is highly mobile.
- the apparatus 1 may be worn or held by the patient as the patient takes exercise.
- FIG. 21 illustrates a rear side of the controller housing 57 .
- the housing 57 defines a recess 260 in the rear side of the housing 57 , and two opposed ledges 261 , 262 which overhang partially over recess 260 , as illustrated most clearly in FIG. 22 .
- the mounting device 250 comprises means for attaching the device 250 to a support, such as an intravenous (IV) pole or a medi-rail, and hook means for supporting a medical device, such as the controller housing 57 .
- a support such as an intravenous (IV) pole or a medi-rail
- hook means for supporting a medical device such as the controller housing 57 .
- the attachment means is provided, in this case, by a releasable clamp 251 .
- the attachment means may alternatively be provided by a clip, such as a belt-clip.
- the hook means is configured to define a plurality of, in this case four, support surfaces 252 for supporting the housing 57 in an upright configuration.
- the support surfaces 252 are provided by a lip 253 which protrudes from a main body 254 of the mounting device 250 .
- the lip 253 is spaced from the main body 254 by two legs 255 ( FIG. 23 ).
- the mounting device 250 is used to support the controller housing 57 , as illustrated in FIGS. 24 and 25 .
- the lip 253 of the mounting device 250 may be inserted into the wider end of the recess 260 in the rear side of the controller housing 57 and then slid along the recess 260 until the lip 253 is partially enclosed behind the ledges 261 , 262 .
- the controller housing 57 is releasably supported by the mounting device 250 ( FIGS. 24 and 25 ).
- the lip 253 comprises a plurality of support surfaces 252 . This arrangement enables the controller housing 57 , or any other suitable medical device, to be supported in an upright orientation when the mounting device 250 is clamped to a horizontal support, such as a medi-rail ( FIG. 24 ), or when the mounting device 250 is clamped to a vertical support, such as an IV pole ( FIG. 25 ).
- support surfaces 252 may be arranged at angles other than 90° relative to one another.
- FIGS. 26 and 27 there is illustrated another mounting device which is similar to the mounting device 250 of FIGS. 23 to 25 , and similar elements in FIGS. 26 and 27 are assigned the same reference numerals.
- the attachment means is provided by a sleeve 270 and the hook means may be moved relative to the sleeve 270 to selectively disassociate the hook means from the attachment means.
- the sleeve 270 defines a groove 271 in which the main body 254 may be slidably received ( FIG. 26 ).
- the sleeve 270 may be permanently or temporarily attached to a support, such as a medi-rail, or an IV pole, or a ventilator 200 , as illustrated in FIG. 27 , by means of fixing pins inserted through apertures 272 in sleeve 270 .
- FIGS. 28 to 30 there is illustrated another apparatus 100 according to the invention, which is similar to the apparatus 1 of FIGS. 1 to 27 , and similar elements in FIGS. 28 and 29 are assigned the same reference numerals.
- the connector 101 is of a general L-shape.
- the aerosol supply conduit is defined by the neck 30 of the aerosol generator housing 4 , and the inlet 102 of the gas conduit extends co-axially around the neck 30 .
- a plurality of inward protrusions 103 are provided on the inlet 102 of the gas conduit, spaced radially around the circumference of the inlet 102 ( FIG. 28 ).
- the connector 101 is releasably mounted to the aerosol generator housing 4 by means of an interference fit between the protrusions 103 and the neck 30 of the aerosol generator housing 4 .
- This arrangement facilitates passage of air into the inlet 102 of the gas conduit between the protrusions 103 .
- An intermediate elbow portion 104 is provided to connect the face mask 50 to the outlet 105 of the gas conduit.
- the elbow 104 is mounted to the face mask 50 in such a manner that movement of the face mask 50 relative to the elbow 104 is possible, in particular the face mask 50 is rotatable about the elbow 104 .
- the elbow 104 is also mounted to the outlet 105 of the gas conduit in a moveable manner, in particular rotation of the elbow 104 and the face mask 50 about the longitudinal axis of the outlet 105 of the gas conduit is possible, as illustrated in FIG. 28 .
- This arrangement facilitates use of the face mask 50 with a patient in a sitting/standing position, or in a lying position, or in any inclined position, while maintaining the reservoir 2 and the aerosol generator housing 4 assembly in a suitable orientation that enables gravitational flow of the liquid medicament from the reservoir 2 to the aerosol generator 3 .
- the apparatus 100 is also suitable for use with the mouthpiece 51 , as illustrated in FIG. 30 , or with any other suitable respiratory conduit, such as the inter-tracheal tube 52 .
- the power usage of the apparatus 1 is relatively low, in this case approximately 1.5 W, thus the associated heat generated during use is negligible.
- the apparatus 1 may therefore be placed as close to the patient as desired, even touching the patient for long periods of use without causing discomfort to the patient, or without burning the patient.
- the cap 10 is mounted to the reservoir 2 . Therefore, there are no loose parts which could be contaminated, broken or lost during filling or refilling of the reservoir 2 .
- the aerosol generator 3 produces an aerosol of medication with consistent mono-dispersed particles within a controlled range of aerosol particle sizes. No filters/baffles or flow disrupters are required between the aerosol generator and the respiratory system of the patient, and no degradation of the medication occurs as a result of the aerosol generation process.
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Abstract
Description
- This application claims priority the following U.S. Provisional Patent Applications, the entire disclosures of both of which are herein incorporated by reference in their entireties for all purposes: U.S. Prov. Pat. Appl. No. 60/344,484, entitled “APPARATUS AND METHODS FOR DELIVERY OF MEDICAMENTS TO A RESPIRATORY SYSTEM,” filed Nov. 1, 2001 by John S. Power et al.; and U.S. Prov. Pat. Appl. No. 60/381,830, entitled “APPARATUS AND METHODS FOR DELIVERY OF MEDICAMENT TO A RESPIRATORY SYSTEM,” filed on May 20, 2002 by John Power et al.
- This invention relates to apparatus and methods for delivery of medicament to the respiratory system of a patient. In particular, the invention relates to apparatus and methods for use with a nebulizer.
- It is known to use a nebulizer to create an aerosol of medication for delivery into the respiratory system of a patient. Typically the medication is placed in a cup which is held over a reservoir of buffer water. A piezoelectric element is vibrated ultrasonically under the buffer water transferring energy to the water, thus causing an aerosol to be formed in the medication cup. Baffles are provided between the medication cup and the airway in an attempt to ensure large particles of medication rain out on the baffles and drip back down into the medication cup.
- However, these nebulizers suffer from a number of disadvantages. In particular, medications have a range of different viscosities, but particle generation is not consistent across the range. Thus the medication particle size is not accurately controlled and a broad range of particles pass into the patient airway. Impaction filters/baffles are often used to attempt to “rain-out” larger particles due to impact of the larger particles with the filters/baffles. Nebulized medication which rains out drips back into the cup only to be nebulized again. This impaction of the nebulized medication may degrade or destroy the medication, and this is particularly the case for long molecular structures, such as proteins.
- The medication in the cup is directly exposed to the airway. Therefore the nebulizer must be maintained substantially horizontal at all times to prevent medication spilling out into the patient airway. Also the ventilator pressure may be lost when the medication cup is removed to refill it.
- This method of aerosol generation requires a relatively large amount of energy. The response time of aerosol generation is therefore large. A considerable amount of heat is generated during use of the nebulizer, therefore to prevent patient discomfort or injury the nebulizer must be placed away from the patient. This necessitates a long inhalation tube between the nebulizer and the patient, which increases drug loss through rain out along the inhalation tube, and further increases the response time to patient inspiration. Furthermore the generated heat degenerates the medication, which can be particularly harmful to protein based drugs.
- This invention is related to apparatus and methods for delivery of medicament to the respiratory system of a patient which overcome at least some of these disadvantages.
- According to the invention, there is provided an apparatus for delivery of a medicament to a respiratory system, the apparatus comprising a reservoir for a liquid medicament for delivery to a respiratory system, the reservoir having a liquid medicament inlet port and a medicament outlet; an aerosol generator at the medicament outlet of the reservoir for aerosolizing a liquid medicament; and a connector for entraining an aerosolized medicament from the aerosol generator with a gas.
- In one embodiment of the invention the inlet port is an upper inlet port and the outlet is a lower outlet for gravitational flow of a liquid medicament from the reservoir to the aerosol generator. In one case the apparatus comprises a plug for selectively sealing the inlet port. The plug may be attached to the reservoir for movement between a sealed position and an open position. Ideally the plug is attached to the reservoir by an arm. The arm may be biased towards the open position.
- In one embodiment the arm defines a hinge for pivoting of the plug between the sealed position and the open position. The hinge may be a live hinge.
- In another embodiment the plug is integral with the arm. Ideally the arm is integral with at least part of the reservoir.
- In another embodiment of the invention the reservoir defines an access opening in a wall of the reservoir to facilitate access to an interior of the reservoir, and the reservoir comprises a cap for mounting at the access opening. The inlet port may be small relative to the access opening. In one case the inlet port is provided through the cap. Ideally the plug is integral with the cap. In one case the cap is mountable at the access opening in a snap-fit arrangement.
- In one embodiment the plug seals the inlet port in a snap-fit arrangement.
- An interior surface of the reservoir may be configured to promote flow of a liquid medicament towards the aerosol generator. Ideally the interior surface of the reservoir is inclined towards the aerosol generator. The reservoir may define a substantially conical shape at least in the region adjacent the aerosol generator.
- In another embodiment of the invention the connector comprises a gas conduit having an inlet and an outlet, and an aerosol supply conduit for delivering an aerosolized medicament from the aerosol generator into the gas conduit to entrain the aerosolized medicament with a gas. The aerosol supply conduit may subtend an angle of less than 90° with the inlet of the gas conduit. In one case the aerosol supply conduit subtends an angle of less than 80° with the inlet of the gas conduit. Ideally the aerosol supply conduit subtends an angle of about 75° with the inlet of the gas conduit.
- In another embodiment the aerosol supply conduit is co-axial with the inlet of the gas conduit.
- The inlet of the gas conduit may extend co-axially around the aerosol supply conduit.
- In another embodiment of the invention, the aerosol supply conduit subtends an angle of 90° with the inlet of the gas conduit.
- In one embodiment of the invention the apparatus comprises a respiratory conduit for connecting the outlet of the gas conduit to a respiratory system. The respiratory conduit may be mounted to the connector at the outlet of the gas conduit. In one case the respiratory conduit is releasably mounted to the connector at the outlet of the gas conduit. The respiratory conduit may be mounted to the connector by an interference fit between the respiratory conduit and the outlet of the gas conduit.
- In another embodiment of the invention the apparatus comprises an intermediate connector mounted between the respiratory conduit and the outlet of the gas conduit. The intermediate connector may have a lumen extending therethrough, and the cross-sectional area of the lumen may vary along the length of the lumen. Preferably the cross-sectional area of the lumen varies in a discontinuous manner along the length of the lumen.
- In one case the respiratory conduit is mounted to the intermediate connector by an interference fit between the respiratory conduit and the intermediate connector. In another case the intermediate connector is mounted to the outlet of the gas conduit by an interference fit between the intermediate connector and the outlet of the gas conduit.
- Ideally the intermediate connector comprises handle means for gripping the intermediate connector. The handle means may comprise one or more formations on the intermediate connector. Preferably the formation comprises a protruding flange. Most preferably the handle means comprises two substantially diametrically opposed protruding flanges.
- In one embodiment the respiratory conduit is moveable relative to the gas conduit. Ideally the respiratory conduit is rotatable about the longitudinal axis of the outlet of the gas conduit.
- In one case the respiratory conduit is selected from a group consisting of a mouthpiece, a face mask, and an inter-tracheal tube. The respiratory conduit may comprise an intermediate portion between the outlet of the gas conduit and the mouthpiece, or the face mask, or the inter-tracheal tube, the intermediate portion being moveable relative to the mouthpiece, or the face mask, or the inter-tracheal tube. In one embodiment the respiratory conduit defines a delivery path to a respiratory system, the delivery path being defined by a distance between the aerosol generator and the respiratory system, the delivery path having a length of less than about 500 mm. The respiratory conduit may have a delivery path of less than about 300 mm.
- In one case the delivery path is substantially free of baffles and/or flow disrupters.
- In another embodiment the respiratory conduit includes a Y-shaped section which separates into a first arm for inhalation to a respiratory system and a second arm for exhalation from a respiratory system.
- The apparatus may comprise a ventilator conduit for connecting the inlet of the gas conduit to a ventilator. In one case the ventilator conduit is mounted to the connector at the inlet of the gas conduit. Ideally the ventilator conduit is releasably mounted to the connector at the inlet of the gas conduit. The ventilator conduit may be mounted to the connector by an interference fit between the ventilator conduit and the inlet of the gas conduit.
- In another embodiment of the invention the apparatus comprises an intermediate connector mounted between the ventilator conduit and the inlet of the gas conduit. The intermediate connector may have a lumen extending therethrough, and the cross-sectional area of the lumen may vary along the length of the lumen. Preferably the cross-sectional area of the lumen varies in a discontinuous manner along the length of the lumen.
- In one case the ventilator conduit is mounted to the intermediate connector by an interference fit between the ventilator conduit and the intermediate connector. In another case the intermediate connector is mounted to the inlet of the gas conduit by an interference fit between the intermediate connector and the inlet of the gas conduit.
- Ideally the intermediate connector comprises handle means for gripping the intermediate connector. The handle means may comprise one or more formations on the intermediate connector. Preferably the formation comprises a protruding flange. Most preferably the handle means comprises two substantially diametrically opposed protruding flanges.
- In one embodiment of the invention the apparatus comprises an aerosol generator housing in which the aerosol generator is held, and the connector is mounted to the aerosol generator housing. The connector may be releasably mounted to the aerosol generator housing. Ideally the connector is mounted to the aerosol generator housing by an interference fit between the aerosol generator housing and the aerosol supply conduit. The connector may be mounted to the aerosol generator housing by an interference fit between the aerosol generator housing and the inlet of the gas conduit.
- In one case the aerosol generator housing is fixed to the reservoir.
- The aerosol generator housing may be integral with the reservoir.
- In another case the apparatus comprises a signal interface to receive a control signal to control operation of the aerosol generator. The apparatus may comprise a controller to control operation of the aerosol generator, the controller being connectable to the signal interface. In one embodiment the controller has an on-board power source. The controller may comprise a power connector, the power connector being connectable to a remote power source.
- In another embodiment the controller comprises a timer to automatically switch the aerosol generator between an active state and a rest state. The timer may be selectively programmable.
- The controller ideally comprises a user interface to selectively control operation of the aerosol generator. The user interface may be remote from the aerosol generator housing.
- In another embodiment the controller comprises status indication means to indicate the operational state of the aerosol generator. The status indication means comprises at least one visual indicator.
- Ideally the controller comprises a housing having a support to receive a mounting device. The support may comprise a recess in the housing for receiving a mounting device. In one case the support comprises at least one ledge overhanging the recess for engagement of a mounting device in the recess. The support may comprise two ledges on opposite sides of the recess.
- In another case the apparatus comprises a mounting device to support the controller. The mounting device may comprise means for attaching the mounting device to a support; and hook means for supporting the housing, the hook means being configured to define a plurality of support surfaces for supporting the housing in an upright configuration. In one embodiment the support surfaces each comprise a lip protruding from a main body of the mounting device. The lip may be engagable in the recess in the housing to support the controller. Ideally the hook means defines four support surfaces. Each support surface may be substantially perpendicular to an adjacent support surface.
- In one case the attachment means is releasable. Ideally the attachment means comprises a clamp.
- In another embodiment the hook means is movable relative to the attachment means to selectively disassociate the hook means from the attachment means. The attachment means may define a groove in which the hook means is slidable to selectively disassociate the hook means from the attachment means.
- In another case the aerosol generator comprises a vibratable member having a plurality of apertures extending between a first surface and a second surface thereof. The first surface may be adapted to receive a liquid medicament from the reservoir. Ideally the aerosol generator is configured to generate an aerosol at the second surface. In one case the vibratable member is dome shaped in geometry. The vibratable member may comprise a piezoelectric element.
- In another embodiment the apertures in the vibratable member are sized to aerosolize the medicament by ejecting droplets of medicament such that about 70% or more of the droplets by weight have a size in the range from about 1 to about 5 micrometers.
- In another aspect of the invention, there is provided a kit for delivery of a medicament to a respiratory system, the kit comprising an apparatus of the invention; and a supply container for delivering a liquid medicament through the inlet port into the reservoir.
- In one embodiment of the invention the supply container defines a delivery tip configured to mate with the inlet port of the reservoir for delivering a liquid medicament through the inlet port into the reservoir. The delivery tip may be configured for insertion at least partially through the inlet port.
- In another embodiment the supply container has indication means to indicate the volume of liquid medicament delivered into the reservoir. The indication means may be provided by at least one marking on the supply container.
- In one case the supply container comprises a nebule. In another case the supply container comprises a syringe.
- According to another aspect, the invention provides a connector for entraining an aerosolized medicament with a gas to deliver the medicament to a respiratory system, the connector comprising a gas conduit having an inlet and an outlet; and an aerosol supply conduit for delivering an aerosolized medicament into the gas conduit to entrain the aerosolized medicament with a gas, the connector comprising a cap to selectively seal the aerosol supply conduit to maintain the pressure in the gas conduit when the connector is not in use.
- In one case the cap is attached to the gas conduit.
- In a further aspect of the invention, there is provided a method of delivering a medicament to a respiratory system, the method comprising the steps of providing a reservoir for a liquid medicament to be delivered to a respiratory system; delivering a volume of the liquid medicament into the reservoir; providing an aerosol generator for aerosolizing the liquid medicament; arranging the aerosol generator beneath the reservoir for gravitational flow of the liquid medicament from the reservoir to the aerosol generator; aerosolizing the liquid medicament; delivering the aerosolized medicament to the respiratory system.
- In one embodiment of the invention the method comprises the step of entraining the aerosolized medicament with a gas before delivering the aerosolized medicament to the respiratory system.
- The aerosol generator may be mounted to the reservoir beneath the reservoir.
- In another case the method comprises the step of vibrating at least part of the aerosol generator to aerosolize the liquid medicament.
- Ideally the method comprises the step of delivering a further volume of the liquid medicament into the reservoir. The further volume of the liquid medicament may be delivered into the reservoir after all of the liquid medicament in the reservoir has been aerosolized. Alternatively the further volume of the liquid medicament may be delivered into the reservoir before all of the liquid medicament in the reservoir has been aerosolized.
- In another embodiment the method comprises the step of opening a port to deliver the volume of the liquid medicament through the port into the reservoir. The method may comprise the step of sealing the port after delivering the volume of the liquid medicament into the reservoir. Ideally the port is sealed before the step of aerosolizing the liquid medicament.
- The inlet port to the reservoir is distanced from the aerosol generator to create a sterile barrier between the carrier delivering the liquid medicament into the reservoir and the respiratory system of the patient.
- The liquid medicament flows by gravitational action from the reservoir to the aerosol generator. This arrangement provides a simple, consistent means of delivering liquid medicament to the aerosol generator, regardless of the viscosity of the liquid medicament.
- The reservoir is configured to promote flow of the liquid medicament towards the aerosol generator. This arrangement minimizes the residual volume of the liquid medicament remaining in the reservoir after use, and also enables the volume of the liquid medicament delivered to the respiratory system of the patient to be accurately controlled.
- The reservoir may be quickly and easily filled or refilled without requiring dismounting of any parts of the assembled apparatus.
- The apparatus of the invention may be quickly and easily cleaned, for example by autoclaving. In particular, the cap may be removed from the relatively large access opening to facilitate cleaning of the interior of the reservoir through the access opening, and also to facilitate egress of material and/or cleaning fluids out of the reservoir through the access opening.
- The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which
-
FIG. 1 is a side, cross-sectional view of an apparatus for delivery of a medicament to a respiratory system according to the invention; -
FIG. 2 is an exploded, perspective view of the apparatus ofFIG. 1 ; -
FIG. 3 is a perspective view of a cap of the apparatus ofFIGS. 1 and 2 ; -
FIG. 4 is a perspective view of the cap ofFIG. 3 mounted to a reservoir of the apparatus ofFIGS. 1 and 2 ; -
FIGS. 5 and 6 are perspective views illustrating filling of the reservoir ofFIG. 4 through the cap; -
FIG. 7 is a perspective view of a controller of the apparatus ofFIGS. 1 and 2 ; -
FIG. 8 is a perspective view of an alternative connector of the apparatus ofFIGS. 1 and 2 ; -
FIG. 9 is a perspective view from beneath of the connector ofFIG. 8 mounted to an aerosol generator housing of the apparatus ofFIGS. 1 and 2 ; -
FIG. 10 is a side view of the apparatus ofFIG. 9 in use mounted to a face mask; -
FIG. 11 is a side view of the apparatus ofFIG. 9 in use mounted to a mouthpiece; -
FIG. 12 is a perspective view of the mouthpiece ofFIG. 11 ; -
FIG. 13 is a side view of the apparatus ofFIG. 9 in use mounted to an inter-tracheal tube; -
FIG. 14 is a perspective view of the apparatus ofFIG. 9 in use in a breathing circuit; -
FIG. 15 is a perspective view of the connector ofFIG. 8 with a cap sealing an aerosol supply conduit of the connector; -
FIG. 16 is a perspective view of the cap ofFIG. 15 ; -
FIG. 17 is a perspective view of the connector of the apparatus ofFIGS. 1 and 2 with the cap ofFIG. 16 sealing an aerosol supply conduit of the connector; -
FIG. 17( a) is a perspective view of another alternative connector of the apparatus ofFIGS. 1 and 2 ; -
FIG. 17( b) is a cross-sectional view along line XVII-XVII inFIG. 17( a); -
FIG. 17( c) is a perspective view of the connector ofFIG. 17( a) in a breathing circuit; -
FIG. 17( d) is a perspective view of an upstream intermediate connector of the apparatus of the invention; -
FIG. 17( e) is a cross-sectional view along line XVIII-XVIII inFIG. 17( d); -
FIG. 17( f) is a perspective view of a downstream intermediate connector of the apparatus of the invention; -
FIG. 17( g) is a cross-sectional view along line XIX-XIX inFIG. 17( f); -
FIG. 17( h) is a perspective view illustrating mounting of the intermediate connectors ofFIGS. 17( d) to 17(g) to the connector ofFIG. 17( a); -
FIG. 17( i) is a perspective view of the intermediate connectors ofFIGS. 17( d) to 17(g) and the connector ofFIG. 17( a) in a breathing circuit; -
FIG. 17( j) is a perspective view of another upstream intermediate connector of the apparatus of the invention; -
FIG. 17( k) is a perspective view of another downstream intermediate connector of the apparatus of the invention; -
FIG. 17( m) is a perspective view illustrating mounting of the intermediate connectors ofFIGS. 17( j) and 17(k) to the connector ofFIG. 17( a); -
FIGS. 18 to 20 are flow diagrams illustrating operational arrangements for using the apparatus; -
FIG. 21 is a plan view of a rear side of the controller ofFIG. 7 ; -
FIG. 22 is a perspective view along the rear side of the controller ofFIG. 21 ; -
FIG. 23 is a perspective view of a mounting device; -
FIGS. 24 and 25 are perspective views of the mounting device ofFIG. 23 supporting the controller ofFIG. 21 ; -
FIG. 26 is an exploded, perspective view of another mounting device in use with the controller ofFIG. 21 ; and -
FIG. 27 is a side view of the apparatus ofFIG. 9 in use with the controller ofFIG. 21 and the mounting device ofFIG. 26 . - Referring to the drawings and initially to
FIGS. 1 to 7 thereof, there is illustrated anapparatus 1 according to the invention for delivering a medicament to a respiratory system. - The
apparatus 1 comprises areservoir 2 for a liquid medicament for delivery to a respiratory system, anaerosol generator 3 for aerosolizing the liquid medicament, and aconnector 6 for entraining the aerosolized medicament from theaerosol generator 3 with a gas. - The
reservoir 2 comprises alower portion 7 and anupper portion 8, as illustrated inFIGS. 1 and 2 , the twoportions portions reservoir 2. Alternatively theportions - An access opening 9 is defined in a wall of the
upper portion 8 of the reservoir 2 (FIG. 2 ), theopening 9 facilitating access to the interior of thereservoir 2, for example for cleaning the interior of thereservoir 2. Thereservoir 2 comprises acap 10 for mounting at the access opening 9 to close theopening 9 when theapparatus 1 is in use (FIG. 1 ). Thecap 10 may define a suitable projectingannular lip 15 for snap-fit mounting of thecap 10 at theopening 9. - The
reservoir 2 has an upper liquidmedicament inlet port 11 for delivering the liquid medicament into thereservoir 2. Theinlet port 11, which is small relative to theaccess opening 9, is provided through thecap 10, as illustrated inFIG. 1 . - A
plug 12 is provided to seal theinlet port 11, theplug 12 being attached to thecap 10 by anarm 13 for movement of theplug 12 between a sealed position (FIG. 6 ) and an open position (FIG. 5 ). Thearm 13 includes a hinge for pivoting of theplug 12 between the sealed position and the open position, preferably the hinge is a live hinge to bias thearm 13 towards the open position. A suitable projectingannular shoulder 14 may be provided on theplug 12 for snap-fit sealing of theinlet port 11 by theplug 12. - The
cap 10,arm 13 and plug 12 may be integrally formed of a polymeric material in a molding process. One suitable material is a silicone material with a Shore A hardness of between 60 and 80. - The
reservoir 2 has alower medicament outlet 16, and theaerosol generator 3 is positioned, when theapparatus 1 is assembled, at the outlet 16 (FIG. 1 ). In use, the liquid medicament flows by gravitational action from thereservoir 2 to theaerosol generator 3. - The
lower portion 7 of thereservoir 2 is substantially conical shaped, sloping towards theaerosol generator 3 to promote flow of the liquid medicament towards theaerosol generator 3 at the outlet 16 (Flow G), as illustrated inFIG. 1 . In this manner, the residual volume of the liquid medicament that remains in thereservoir 2 after use is minimised, and thus the volume of the liquid medicament which is delivered to the respiratory system of the patient is accurately controlled. - A typical volume of liquid medicament that can be held in the reservoir is 10 mL, or 6 mL.
- The
aerosol generator 3 comprises avibratable member 40 and apiezoelectric element 42. The vibratablemember 40 has a plurality of tapered apertures extending between a first surface and a second surface thereof, as described in U.S. Pat. No. 5,164,740, U.S. Pat. No. 5,586,550, U.S. Pat. No. 5,758,637, U.S. Pat. No. 6,085,740, the entire contents of which are incorporated herein by reference. - The first surface of the vibratable
member 40, which in use faces upwardly, receives the liquid medicament from thereservoir 2, and the aerosolised medicament is generated at the second surface of the vibratablemember 40 by ejecting droplets of medicament upon vibration of themember 40. In use the second surface faces downwardly. In one case, the apertures in thevibratable member 40 may be sized to produce an aerosol in which about 70% or more of the droplets by weight have a size in the range from about 1 to 5 micrometers. - The vibratable
member 40 is non-planar, and is preferably dome-shaped in geometry. - The
apparatus 1 comprises anaerosol generator housing 4 fixed to thelower portion 7 of thereservoir 2, for example by integrally manufacturing thehousing 4 and thelower portion 7. - In the assembled apparatus of
FIG. 1 , theaerosol generator 3 is held within theaerosol generator housing 4 between anupper shield 41 and alower retainer 44. Theshield 41, thepiezoelectric element 42, and theretainer 44 have central apertures aligned to facilitate flow of the liquid medicament from thereservoir 2 to theaerosol generator 3, and to facilitate passage of the aerosolized medicament from theaerosol generator 3 into aneck 30 of theaerosol generator housing 4. - An O-
ring seal 46 and asleeve 45 are provided between theretainer 44 and the wall of theaerosol generator housing 4 and theshield 41 is fixed to thelower portion 7 of thereservoir 2. An anti-bacterial coating may be applied to the vibratablemember 40 to ensure a sterile flow of aerosolized medicament into theneck 30. - The
connector 6 comprises a gas conduit having aninlet 61 and anoutlet 62, and anaerosol supply conduit 60 for delivering the aerosolised medicament from theaerosol generator 3 into the gas conduit to entrain the aerosolised medicament with a gas, such as air, passing through the gas conduit. The entrained aerosolised medicament/gas mixture passes out of the gas conduit through theoutlet 62. - The
connector 6 is of a general T-shape, theaerosol supply conduit 60 subtending an angle of about 75° with theinlet 61 of the gas conduit (FIG. 1 ). The longitudinal axis of theinlet 61 of the gas conduit is co-axial with the longitudinal axis of theoutlet 62 of the gas conduit, and the gas conduit tapers slightly outwardly between theinlet 61 and theoutlet 62. - It will be appreciated that the angle subtended between the
aerosol supply conduit 60 and theinlet 61 of the gas conduit may be any suitable angle in the range of from 60° to 90°, but preferably less than 90°, and most preferably from 60° to 80°, to induce the entrained aerosolized medicament/gas mixture to pass out of the gas conduit through theoutlet 62, in particular when theapparatus 1 is used in a floor use non-ventilator application. - The
aerosol supply conduit 60 and the gas conduit meet at a junction 63 (FIG. 1 ). In the assembledapparatus 1, theaerosol supply conduit 60 of theconnector 6 is releasably mounted to theneck 30 of theaerosol generator housing 4 by means of a push-fit arrangement. This enables theconnector 6 to be easily dismounted from theaerosol generator housing 4, for example for cleaning. Theneck 30 at least partially lines the interior of theaerosol supply conduit 60, as illustrated inFIG. 1 . - The
inlet 61 of the gas conduit may be connected to aventilator 70 which pumps a gas, such as air, into the gas conduit, alternatively theapparatus 1 may be employed during manual breathing with theinlet 61 of the gas conduit being open to atmosphere. - The
apparatus 1 also includes acontroller 50 as illustrated inFIG. 7 , to control operation of and to supply power to theaerosol generator 3. Thereservoir 2 has asignal interface port 38 fixed to thelower portion 7 of thereservoir 2 to receive a control signal from thecontroller 50. Thecontroller 50 may be connected to thesignal interface port 38 by means of acontrol lead 52 which has adocking member 51 for mating with theport 38. A control signal and power may be passed from thecontroller 50 through thelead 52 and theport 38 to theaerosol generator 3 to control the operation of theaerosol generator 3 and to supply power to theaerosol generator 3 respectively. - The power source for the
controller 50 may be an on-board power source, such as a rechargeable battery, or a remote power source, such as a mains power source, or a ventilator power source. When the remote power source is an AC mains power source, an AC-DC converter may be connected between the AC power source and thecontroller 50. A power connection lead may be provided to connect apower socket 53 of thecontroller 50 with the remote power source. - The
controller 50 has ahousing 57, and a user interface to selectively control operation of theaerosol generator 3. Preferably the user interface is provided on thehousing 57 which, in use, is located remote from theaerosol generator housing 4. The user interface may be in the form of, for example, an on-off button 54, or a reset button. - A selectively programmable timer may be provided by the
controller 50 to automatically switch theaerosol generator 3 between an active state and a rest state. For example, the timer may be configured to switch theaerosol generator 3 from an active state to a rest state after 15 minutes of aerosol generation. The timer may alternatively be configured to activate generation of the aerosol a short period after commencement of an inhalation cycle, for example within 20 milliseconds, and to cease generation of the aerosol a short period after commencement of an exhalation cycle, for example within 20 milliseconds. - Status indication means are also provided on the
housing 57 to indicate the operational state of theaerosol generator 3. For example, the status indication means may be in the form of two visible LED's, with oneLED 55 being used to indicate a 15 minute timer cycle, and theother LED 56 being used to indicate a 30 minute timer cycle. Alternatively oneLED 55 may be used to indicate an operational state of theaerosol generator 3, and theother LED 56 may be used to indicate a rest state of theaerosol generator 3. - A
fault indicator 58 is also provided in the form of an LED on thehousing 57. Abattery charge indicator 59 in the form of an LED is provided at the side of thehousing 57. - In use, the
cap 10 is mounted at the access opening 9 in a snap-fit manner to close theopening 9. Theplug 12 is then moved from the sealed position (FIG. 6 ) to the open position (FIG. 5 ) by hinging thearm 13 to the open position, and a volume of liquid medicament is delivered through theinlet port 11 into thereservoir 2. - Typically a supply container, such as a nebule 20 (
FIG. 5 ) or a syringe, is used to deliver the liquid medicament through theinlet port 11 into thereservoir 2. In the case ofnebule 20, adelivery tip 21 is defined at an end ofnebule 20 for mating with theinlet port 11 by inserting thedelivery tip 21 at least partially through theinlet port 11. In this way, the volume of liquid medicament may be easily and quickly delivered into thereservoir 2. In particular, it is not necessary to dismount any parts of the assembledapparatus 1 to deliver the liquid medicament into thereservoir 2. - When the desired volume of liquid medicament has been delivered into the
reservoir 2, thearm 13 is hinged to the closed position and theinlet port 11 is sealed by the plug 12 (FIG. 6 ). - The nebule 20 preferably includes markings to indicate the volume of liquid medicament delivered into the
reservoir 2. This provides an accurate means of measuring the volume of liquid medicament being delivered to the respiratory system of a patient. - By distancing the
inlet port 11 to thereservoir 2 from theaerosol generator 3 at theoutlet 16, this arrangement creates a sterile barrier between the carrier delivering the liquid medicament into thereservoir 2 and the respiratory system of the patient. - The liquid medicament in the
reservoir 2 flows by gravitational action towards theaerosol generator 3 at the lower medicament outlet 16 (Flow G). - The
connector 6 is then releasably mounted to theaerosol generator housing 4 at theaerosol supply conduit 60 by means of an interference fit between theneck 30 of theaerosol generator housing 4 and theaerosol supply conduit 60 of the connector 6 (FIG. 1 ). - The docking
member 51 of thecontrol lead 52 is mated with thesignal interface port 38 on thereservoir 2 to connect thecontroller 50 to theaerosol generator 3. Thecontroller 50 may then be activated to supply power and a control signal to theaerosol generator 3, which causes thepiezoelectric element 42 to vibrate thenon-planar member 40. This vibration of thenon-planar member 40 causes the liquid medicament at the top surface of themember 40 to pass through the apertures to the lower surface where the medicament is aerosolized by the ejection of small droplets of medicament. - The aerosolized medicament passes from the
aerosol generator 3 into theneck 30 of the aerosol generator housing 4 (Flow A), which is mounted within theaerosol supply conduit 60 of theconnector 6, and into the gas conduit of the connector 6 (Flow B). The aerosolized medicament is entrained in the gas conduit with a gas, such as air, which passes into the gas conduit through the inlet 61 (Flow C). The entrained mixture of the aerosolized medicament and the gas then passes out of the gas conduit through the outlet 62 (Flow D) and on to the respiratory system of the patient. - As the aerosolized medicament is continuously delivered to the respiratory system of the patient, the volume of liquid medicament in the
reservoir 2 gradually decreases. Thereservoir 2 may be quickly and easily refilled by opening the seal at theinlet port 11 and delivering liquid medicament through theinlet port 11 into thereservoir 2, as described previously with reference toFIGS. 5 and 6 . It is not necessary to dismount any parts of theapparatus 1 during refilling of thereservoir 2. - The generation of aerosolized medicament at the
aerosol generator 3 may continue during refilling, or alternatively the generation may be temporarily stopped during refilling. - The refill arrangement of the
reservoir 2 enables theapparatus 1 to be reused many times. - A suitable material for the
connector 6, and for theintegral reservoir 2 andaerosol generator housing 4 is polysulphone. By manufacturing these components of the apparatus from polysulphone, this enables these components to be autoclaved for multiple use of the same apparatus. Preferably theconnector 6, thereservoir 2 and theaerosol generator housing 4 are suitable to be autoclaved up to 100 times. - An alternative material for the
connector 6, and for theintegral reservoir 2 andaerosol generator housing 4 is polycarbonate. This reduces the component cost, however the number of times these components can be autoclaved and re-used is also reduced by using polycarbonate. - Referring now to
FIGS. 8 and 9 , there is illustrated anotherconnector 64, which is similar to theconnector 6 ofFIGS. 1 and 2 , and similar elements inFIGS. 8 and 9 are assigned the same reference numerals. - The
connector 64 may be substituted for theconnector 6, and thereafter operation of theapparatus 1 of the invention using theconnector 64 proceeds in a manner similar to that described previously with reference toFIGS. 1 to 7 . The gas conduit of theconnector 64 has a smaller diameter and is longer than the gas conduit of theconnector 6 ofFIGS. 1 and 2 . - A respiratory conduit, such as a
face mask 50 to assist breathing of a patient (FIG. 10 ), or a mouthpiece 51 (FIGS. 11 and 12 ), or an inter-tracheal tube 52 (FIG. 13 ) may be provided to connect theoutlet 62 of the gas conduit with the respiratory system of the patient. Therespiratory conduit connector 64 at theoutlet 62 of the gas conduit in a releasable manner, for example by means of an interference fit between therespiratory conduit outlet 62 of the gas conduit (FIGS. 10 , 11, 13). - The
apparatus 1 is lightweight. By mounting theapparatus 1 to theface mask 50 which may be worn by a patient, theapparatus 1 may be used during movement of the patient. During such movement, theapparatus 1 is supported by theface mask 50 due to the interference fit between theface mask 50 and theoutlet 62 of the gas conduit, theface mask 50 being in turn held in place on the patient by means of straps. - The delivery path between the
aerosol generator 3 and the respiratory system of the patient may be 500 mm or shorter, for example approximately 300 mm. No baffles or flow disrupters are provided along the delivery path. - A ventilator conduit 53 (
FIG. 14 ) may be provided to connect a ventilator to theinlet 61 of the gas conduit. Theventilator conduit 53 may be mounted to theconnector 64 at theinlet 61 of the gas conduit in a releasable manner, for example by means of an interference fit between theventilator conduit 53 and theinlet 61 of the gas conduit (FIG. 14 ). The ventilator can be used to pump air, or oxygen, or any other suitable gas or gas mixture into theinlet 61 of the gas conduit. -
FIG. 14 illustrates the assembledapparatus 1 of the invention with theventilator conduit 53 mounted to theinlet 61 of the gas conduit, and the respiratory conduit mounted to theoutlet 62 of the gas conduit. The respiratory conduit includes a Y-shapedsection 54 which separates into afirst arm 55 for inhalation to the respiratory system of the patient (Flow E) and asecond arm 56 for exhalation from the respiratory system (Flow F). - It will be appreciated that any of the
face mask 50, or themouthpiece 51, or theinter-tracheal tube 52 may be provided between thefirst arm 55 and the respiratory system. - In use, a ventilator pumps a gas, such as air, through the
ventilator conduit 53 into theinlet 61 of the gas conduit (Flow E). The generated aerosol of medicament passes from theaerosol generator 3 through theneck 30 of theaerosol generator housing 4, which lines theaerosol supply conduit 60 of theconnector 64, and into the gas conduit of theconnector 64. The aerosolized medicament is entrained with the air in the gas conduit, and the entrained mixture passes out of the gas conduit through theoutlet 62 and into aninlet tube 157 of the Y-shapedsection 54. The entrained mixture then passes through thefirst arm 55 to the respiratory system of the patient (Flow E). Upon exhalation, the exhaled gases pass from the respiratory system through thefirst arm 55, on through thesecond arm 56 to the atmosphere (Flow F). - It will further be appreciated that the Y-shaped
section 54 may be provided upstream of theapparatus 1 in the ventilator circuit. - A capping
device 70 may be provided for theconnector 64 to selectively seal theaerosol supply conduit 60, as illustrated inFIGS. 15 and 16 . In this case, thecapping device 70 comprises aninsertion plug 71 connected to a mountingring 73 by anarm 72. Thering 73 is usually mounted around the gas conduit (FIG. 15 ). - The
capping device 70 may be used to seal theaerosol supply conduit 60 by inserting theplug 71 into theaerosol supply conduit 60 when theaerosol generator housing 4 is dismounted from theconnector 64, as illustrated inFIG. 15 . By sealing theaerosol supply conduit 60, this ensures that the pressure in the gas conduit is maintained when theaerosol generator housing 4 has been dismounted. This is particularly advantageous when theconnector 64 is connected in position in a ventilator circuit, as illustrated inFIG. 14 , in which case the pressure in the ventilator circuit will be maintained by the cappingdevice 70 when theaerosol generator housing 4 has been dismounted from theconnector 64. - A
tab 74 on theplug 71 enables ease of removal of theplug 71 from within theaerosol supply conduit 60. - When not in use, the
capping device 70 may simply hang from thering 73 mounted around the gas conduit. - The
capping device 70 is also suitable for use with theconnector 6, as illustrated inFIG. 17 . - It will further be appreciated that the
capping device 70 may be used to seal any suitable part of a pressure circuit. - Referring now to
FIGS. 17( a) to 17(c), there is illustrated anotherconnector 300, which is similar to theconnector 6 ofFIGS. 1 and 2 , and similar elements inFIGS. 17( a) and 17(b) are assigned the same reference numerals. - In this case, the
aerosol supply conduit 60 is substantially perpendicular to the gas conduit, theaerosol supply conduit 60 subtending an angle of approximately 90° with theinlet 61 of the gas conduit (FIG. 17( b)). - In addition, the gas conduit of the
connector 300 has a substantially smaller diameter, for example approximately 15 mm, than the gas conduit of theconnector 6 ofFIGS. 1 and 2 . Theconnector 300 is thus particularly suitable for use in a pediatric care application. The diameter of theaerosol supply conduit 60 is the same for both theconnector 300 and theconnector 6 ofFIGS. 1 and 2 . A suitable diameter for theaerosol supply conduit 60 may be, as an example, approximately 22 mm. -
FIG. 17( c) illustrates the apparatus of the invention with a small diameterpediatric ventilator conduit 353 releasably mounted to theconnector 300 at theinlet 61 of the gas conduit by means of an interference fit between themale ventilator conduit 353 and thefemale inlet part 61. A small diameter pediatric Y-shapedrespiratory section 354 is releasably mounted to theconnector 300 at theoutlet 62 of the gas conduit by means of an interference fit between thefemale inlet tube 157 of the Y-shapedsection 354 and themale outlet part 62. The Y-shapedsection 354 separates into afirst arm 55 for inhalation to the respiratory system of the patient (Flow E) and asecond arm 56 for exhalation from the respiratory system (Flow F). - The pediatric apparatus of
FIG. 17( c) operates in a manner similar to that described previously with reference toFIG. 14 . -
FIGS. 17( d) and 17(e) illustrate an upstreamintermediate connector 400 having anupstream end 402 and adownstream end 403. Alumen 406 extends through theintermediate connector 400 from theupstream end 402 to thedownstream end 403. As illustrated inFIG. 17( e), the cross-sectional area of thelumen 406 increases along the length of theintermediate connector 400 from theupstream end 402 to thedownstream end 403 in a discontinuous fashion at anelbow 408. - In
FIGS. 17( f) and 17(g) there is illustrated a downstreamintermediate connector 401 having anupstream end 404 and adownstream end 405. Alumen 407 extends through theintermediate connector 401 from theupstream end 404 to thedownstream end 405. As illustrated inFIG. 17( g), the cross-sectional area of thelumen 407 decreases along the length of theintermediate connector 401 from theupstream end 404 to thedownstream end 405 in a discontinuous fashion at twoelbows - The upstream
intermediate connector 400 may be releasably mounted to theinlet 61 of the gas conduit of theconnector 300 by means of an interference fit between thefemale inlet part 61 and the maledownstream end 403 of the intermediate connector 400 (FIG. 17( h)). Similarly the downstreamintermediate connector 401 may be releasably mounted to theoutlet 62 of the gas conduit of theconnector 300 by means of an interference fit between the femaleupstream end 404 of theintermediate connector 401 and the male outlet part 62 (FIG. 17( h)). - As illustrated in
FIG. 17( i), a very small diameter, for example approximately 7.5 mm,neo-natal ventilator conduit 420 may then be releasably mounted to theupstream end 402 of the upstreamintermediate connector 400 by means of an interference fit between the femaleupstream end 402 of the upstreamintermediate connector 400 and themale ventilator conduit 420. Similarly a very small diameter, for example approximately 7.5 mm, neo-natal bifurcated, i.e. Y-shaped,respiratory section 421 may be releasably mounted to thedownstream end 405 of the downstreamintermediate connector 401 by means of an interference fit between themale inlet tube 157 of the Y-shapedsection 421 and the femaledownstream end 405 of the downstreamintermediate connector 401. - In this manner, the
intermediate connectors connector 300 within a neo-natal breathing circuit, as illustrated inFIG. 17( i). In particular, the upstreamintermediate connector 400 provides a step-up in the cross-sectional area of the flow from the smaller diameterneo-natal ventilator conduit 420 to the larger diameter gas conduit of theconnector 300. Also the downstreamintermediate connector 401 provides a step-down in the cross-sectional area of the flow from the larger diameter gas conduit of theconnector 300 to the smaller diameter neo-natal Y-shapedrespiratory section 421. - The Y-shaped
section 421 separates into afirst arm 55 for inhalation to the respiratory system of the patient (Flow E) and asecond arm 56 for exhalation from the respiratory system (Flow F). Operation of the neo-natal apparatus ofFIG. 17( i) operates in a manner similar to that described previously with reference toFIG. 14 . - It is to be noted that the
intermediate connectors connector 300 and theventilator conduit 420 and the Y-shapedsection 421, so that asingle connector 300 may be used for both pediatric care applications (FIG. 17( c)) and neo-natal care applications (FIG. 17( i)). - The upstream
intermediate connector 430 ofFIG. 17( j) has two diametrically opposed protrudingflanges 431 on theelbow 408 of theintermediate connector 430. Similarly the downstreamintermediate connector 432 ofFIG. 17( k) has two diametrically opposed protrudingflanges 431 on theelbow 409 of theintermediate connector 432. - The
flanges 431 provide a handle means for gripping theintermediate connectors intermediate connectors connector 300, as illustrated inFIG. 17( m). This feature may be applied to any of the connectors. - Referring now to
FIGS. 18 to 20 , there are illustrated some possible arrangements for using theapparatus 1, according to the invention, for delivering medicament to arespiratory system 203 of a patient. - In the arrangement of
FIG. 18 , gas is pumped from aventilator 200 into theinlet 61 of the gas conduit (line G). The power source for thecontroller 50 which controls operation of theapparatus 1 is provided by the ventilator 200 (line P). - In the arrangement of
FIG. 19 , gas is pumped from theventilator 200 into theinlet 61 of the gas conduit (line G). The power source for thecontroller 50 is provided by abattery 201 and/or a mains power source 202 (lines P). - In the arrangement of
FIG. 20 , gas is drawn into theinlet 61 of the gas conduit directly from the atmosphere 204 (line G). The power source for thecontroller 50 is provided by thebattery 201 and/or themains power source 202 and/or the ventilator 200 (lines P). - In the case where the power source is provided by the
battery 201, and theinlet 61 is open to theatmosphere 204, theapparatus 1 is highly mobile. In particular, theapparatus 1 may be worn or held by the patient as the patient takes exercise. -
FIG. 21 illustrates a rear side of thecontroller housing 57. Thehousing 57 defines arecess 260 in the rear side of thehousing 57, and twoopposed ledges recess 260, as illustrated most clearly inFIG. 22 . - Referring now to
FIG. 23 , there is illustrated a mountingdevice 250. The mountingdevice 250 comprises means for attaching thedevice 250 to a support, such as an intravenous (IV) pole or a medi-rail, and hook means for supporting a medical device, such as thecontroller housing 57. - The attachment means is provided, in this case, by a
releasable clamp 251. The attachment means may alternatively be provided by a clip, such as a belt-clip. - The hook means is configured to define a plurality of, in this case four, support surfaces 252 for supporting the
housing 57 in an upright configuration. The support surfaces 252 are provided by alip 253 which protrudes from amain body 254 of the mountingdevice 250. Thelip 253 is spaced from themain body 254 by two legs 255 (FIG. 23 ). - In this case, the mounting
device 250 is used to support thecontroller housing 57, as illustrated inFIGS. 24 and 25 . Thelip 253 of the mountingdevice 250 may be inserted into the wider end of therecess 260 in the rear side of thecontroller housing 57 and then slid along therecess 260 until thelip 253 is partially enclosed behind theledges controller housing 57 is releasably supported by the mounting device 250 (FIGS. 24 and 25 ). - The
lip 253 comprises a plurality of support surfaces 252. This arrangement enables thecontroller housing 57, or any other suitable medical device, to be supported in an upright orientation when the mountingdevice 250 is clamped to a horizontal support, such as a medi-rail (FIG. 24 ), or when the mountingdevice 250 is clamped to a vertical support, such as an IV pole (FIG. 25 ). - It will be appreciated that the support surfaces 252 may be arranged at angles other than 90° relative to one another.
- Referring now to
FIGS. 26 and 27 there is illustrated another mounting device which is similar to the mountingdevice 250 ofFIGS. 23 to 25 , and similar elements inFIGS. 26 and 27 are assigned the same reference numerals. - In this case, the attachment means is provided by a
sleeve 270 and the hook means may be moved relative to thesleeve 270 to selectively disassociate the hook means from the attachment means. Thesleeve 270 defines agroove 271 in which themain body 254 may be slidably received (FIG. 26 ). - The
sleeve 270 may be permanently or temporarily attached to a support, such as a medi-rail, or an IV pole, or aventilator 200, as illustrated inFIG. 27 , by means of fixing pins inserted through apertures 272 insleeve 270. - Referring to
FIGS. 28 to 30 , there is illustrated anotherapparatus 100 according to the invention, which is similar to theapparatus 1 ofFIGS. 1 to 27 , and similar elements inFIGS. 28 and 29 are assigned the same reference numerals. - In this case, the
connector 101 is of a general L-shape. The aerosol supply conduit is defined by theneck 30 of theaerosol generator housing 4, and theinlet 102 of the gas conduit extends co-axially around theneck 30. - A plurality of
inward protrusions 103 are provided on theinlet 102 of the gas conduit, spaced radially around the circumference of the inlet 102 (FIG. 28 ). Theconnector 101 is releasably mounted to theaerosol generator housing 4 by means of an interference fit between theprotrusions 103 and theneck 30 of theaerosol generator housing 4. - This arrangement facilitates passage of air into the
inlet 102 of the gas conduit between theprotrusions 103. - An
intermediate elbow portion 104 is provided to connect theface mask 50 to theoutlet 105 of the gas conduit. Theelbow 104 is mounted to theface mask 50 in such a manner that movement of theface mask 50 relative to theelbow 104 is possible, in particular theface mask 50 is rotatable about theelbow 104. Theelbow 104 is also mounted to theoutlet 105 of the gas conduit in a moveable manner, in particular rotation of theelbow 104 and theface mask 50 about the longitudinal axis of theoutlet 105 of the gas conduit is possible, as illustrated inFIG. 28 . This arrangement facilitates use of theface mask 50 with a patient in a sitting/standing position, or in a lying position, or in any inclined position, while maintaining thereservoir 2 and theaerosol generator housing 4 assembly in a suitable orientation that enables gravitational flow of the liquid medicament from thereservoir 2 to theaerosol generator 3. - The
apparatus 100 is also suitable for use with themouthpiece 51, as illustrated inFIG. 30 , or with any other suitable respiratory conduit, such as theinter-tracheal tube 52. - The power usage of the
apparatus 1 is relatively low, in this case approximately 1.5 W, thus the associated heat generated during use is negligible. Theapparatus 1 may therefore be placed as close to the patient as desired, even touching the patient for long periods of use without causing discomfort to the patient, or without burning the patient. - The
cap 10 is mounted to thereservoir 2. Therefore, there are no loose parts which could be contaminated, broken or lost during filling or refilling of thereservoir 2. - The
aerosol generator 3 produces an aerosol of medication with consistent mono-dispersed particles within a controlled range of aerosol particle sizes. No filters/baffles or flow disrupters are required between the aerosol generator and the respiratory system of the patient, and no degradation of the medication occurs as a result of the aerosol generation process. - The invention is not limited to the embodiments hereinbefore described, with reference to the accompanying drawings, which may be varied in construction and detail.
Claims (15)
Priority Applications (2)
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US12/583,256 US20090308384A1 (en) | 2001-11-01 | 2009-08-17 | Apparatus and methods for delivery of medicament to a respiratory system |
US16/733,355 US20200197647A1 (en) | 2001-11-01 | 2020-01-03 | Apparatus and methods for delivery of medicament to a respiratory system |
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US38183002P | 2002-05-20 | 2002-05-20 | |
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US12/583,256 US20090308384A1 (en) | 2001-11-01 | 2009-08-17 | Apparatus and methods for delivery of medicament to a respiratory system |
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US16/733,355 Abandoned US20200197647A1 (en) | 2001-11-01 | 2020-01-03 | Apparatus and methods for delivery of medicament to a respiratory system |
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US20200197647A1 (en) | 2020-06-25 |
US20030150445A1 (en) | 2003-08-14 |
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