# US 2008/0184993 A1 · Devices and methods for nebulizing fluids for inhalation

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- Number: US 2008/0184993 A1
- Document ID: US20080184993A1
- Status: Published application
- Kind: A1
- Application number: 12/099,302
- Filed: 2008-04-08
- Published: 2008-08-07
- Earliest claimed: 2002-01-07
- Assignees: Aerogen, Inc.
- Inventors: Rajan Patel; Michael A. Klimowicz
- Web page: https://patentgrep.com/patent/US20080184993A1

## CPC

- A61M 15/0085: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 11/005: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 11/007: {Syringe-type or piston-type sprayers or atomisers}
- A61M 15/0065: {Inhalators with dosage or measuring devices (A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52)}
- A61M 15/0066: {with means for varying the dose size}
- B05B 17/0646: {Vibrating plates, i.e. plates being directly subjected to the vibrations, e.g. having a piezoelectric transducer attached thereto}
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2016/0024: {with an on-off output signal, e.g. from a switch}
- A61M 2205/50: with microprocessors or computers
- A61M 2205/583: by visual feedback
- A61M 2205/584: having a color code
- A61M 2205/8206: battery-operated
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B05B: SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES (spray-mixers with nozzles B01F25/72; processes for applying liquids or other fluent materials to surfaces by spraying B05D)

## Abstract

A nebulizer comprising an aerosol generator and a titration mechanism comprising a dosing mechanism, a screw assembly, a plunger and an actuator, wherein the dosing mechanism is rotatably mounted in the nebulizer and the plunger is mounted in the nebulizer to travel along a longitudinal axis substantially perpendicular to the plane of rotation of the dosing mechanism. The actuator is mounted to the nebulizer to travel in the direction of the longitudinal axis. The screw mechanism allows the rotation of the dosing mechanism to fix a variable distance of travel of the plunger based on the selected dose, without moving the plunger longitudinally. This allows the user to verify and if necessary correct the selected dose prior to any drug being released from the vial. Operation of the actuator causes longitudinal movement, through the screw mechanism, to the plunger. The actuator always moves a fixed distance along the longitudinal axis, while the plunger always moves a variable distance depending on rotation of the dosing mechanism to a selected dose.

## Claims

### Claim 1

A method of delivering a nebulized fluid for inhalation, comprising the steps of:
providing an aerosol generator, a container containing a fluid to be nebulized, a reservoir in fluid communication with the container and with the aerosol generator, a moveable member positioned to act upon the container in a manner to eject fluid therefrom, and a linkage mechanism coupled to the moveable member to selectively control the distance of movement of the moveable member,
selecting a distance of travel of the of the moveable member,
moving the moveable member to eject fluid from the container into the reservoir,
operating the aerosol generator to eject fluid from the reservoir as a nebulized fluid for inhalation.

### Claim 2

A nebulizer comprising a titration mechanism, a dispensing mechanism aerosol generator;
the titration mechanism comprises:
a housing configured to receive a medicine vial defining a central axis therein,
a plunger movably mounted within the housing to travel to and fro substantially parallel to the central axis of a vial when such a vial is received within the housing,
an actuator button configured to move the plunger when said actuator button is pressed by a user;
a titration control mechanism operable to selectively control the distance of travel of the plunger when the actuator button is pressed, and
wherein the dispensing mechanism comprises:
a cannula, a reservoir comprising a lumen defined by a wall, and a delivery tube in fluid communication between the cannula and the reservoir lumen wherein the cannula is configured to engage in fluid communication with a medicine vial and wherein fluid can be moved from a medicine vial through the cannula and through the delivery tube to the reservoir; and
wherein the aerosol generator is mounted within the lumen wall of the reservoir such that when the aerosol generator is operated, fluid within the reservoir is moved from the reservoir and released therefrom as a mist.

### Claim 3 (depends on 2)

The nebulizer of claim 2, wherein the titration control mechanism comprises a numerical indicator capable of providing a numerical value corresponding the distance of travel of the plunger that the titration control mechanism will provide for a selected numerical value provided by the numerical indicator.

### Claim 4 (depends on 3)

The nebulizer of claim 3, wherein the numerical indicator is capable of providing a plurality of numerical values corresponding to discrete distances of travel of the plunger that the titration control mechanism will provide for a selected numerical value provided by the numerical indicator.

### Claim 5 (depends on 3)

The nebulizer of claim 3, wherein the plurality of numerical values of the numerical indicator are indexed to discrete volumetric amounts corresponding to the volume of fluid displaced by a predetermined distance of travel of the plunger when a vial containing fluid is received within the titration control mechanism housing.

### Claim 6 (depends on 3)

The nebulizer of claim 3, wherein the plurality of numerical values of the numerical indicator are indexed to discrete volumetric amounts corresponding to the volume of fluid displaced by a predetermined distance of travel of the plunger when a vial containing fluid is received within the titration control mechanism housing.

### Claim 7 (depends on 2)

The nebulizer of claim 2 wherein the titration control mechanism further comprises a screw assembly that allows the plunger to travel a selected distance by a fixed distance of movement of the actuator button.

### Claim 8 (depends on 7)

The nebulizer of claim 7, wherein the titration control mechanism comprises a numerical indicator capable of providing a numerical value corresponding the distance of travel of the plunger that the titration control mechanism will provide for a selected numerical value provided by the numerical indicator.

### Claim 9 (depends on 1)

The method of claim 1, wherein the container defines a longitudinal axis and the moveable member is moveable in a direction substantially parallel to the longitudinal axis.

### Claim 10 (depends on 1)

The method of claim 1, further comprising:
providing a titration mechanism in the aerosol generator, the titration mechanism comprising a dosing mechanism, a screw mechanism, an actuator and a plunger, the plunger movable along a longitudinal axis within the aerosol generator, the actuator movable a fixed distance X along the axis defined by the plunger and the dosing mechanism rotatable in a plane substantially perpendicular to the longitudinal axis;
providing a vial mechanism comprising a vial, the vial having a longitudinal axis and a movable seal movable along the longitudinal axis;
inserting the vial mechanism into the aerosol generator such that the longitudinal axis of the vial is substantially parallel to the longitudinal axis of the plunger;
rotating the dosing mechanism to select a dose, operating the screw mechanism, by rotating the dosing mechanism, to set a variable distance Y of travel of the plunger corresponding to a selected dose without imparting longitudinal travel of the plunger;
moving the actuator longitudinally the fixed distance X to move the plunger longitudinally the selected variable distance Y;
moving a movable stopper the variable distance Y by movement of the plunger the selected variable distance Y; and
displacing a volume of liquid, corresponding to the selected dose, from the vial to contact the aerosol generator.

### Claim 11 (depends on 10)

The method of claim 10, wherein the aerosol generator comprises an aerosolization element having a first face, a second face and a plurality of apertures therethrough and wherein operating the aerosol generator comprises vibrating the aerosolization element.

### Claim 12 (depends on 10)

The method of claim 10, further comprising inserting a reservoir into the aerosol generator, and wherein the liquid is displaced from the vial into the reservoir.

### Claim 13 (depends on 1)

The method of claim 1, further comprising:
providing a titration mechanism comprising a longitudinally moveable plunger, the movement thereof defining a longitudinal axis, a longitudinally moveable actuator to move the plunger, the movement of the actuator defining a longitudinal axis, and a screw mechanism to set the distance of travel of the plunger;
providing a rotatably mounted dosing mechanism, the rotation thereof defining an axis of rotation; and
providing a vial mechanism comprising a vial defining a longitudinal access and a moveable seal moveable along the longitudinal access of the vial.

### Claim 14 (depends on 13)

The method of claim 13, further comprising:
providing a controller to control operation of the aerosol generator;
placing the vial mechanism within the aerosol generator such that the longitudinal axis of the vial is substantially coaxial with the axis of rotation of the dosing mechanism;
rotating the dosing mechanism to select a dose; and
moving the actuator to move the plunger such that fluid is dispensed from the vial.

### Claim 15 (depends on 7)

The nebulizer of claim 7, wherein the screw assembly is further operable through a range of operating positions situated to act upon the moveable member to selectively limit the distance of movement of the moveable member, and the screw assembly is set to a distance of movement of the moveable member to a selected operating position.

### Claim 16 (depends on 7)

The nebulizer of claim 7, further comprising a visual indicator linked to the screw assembly such that operation of the screw assembly causes a visual indication corresponding to the distance of movement the moveable member can move for a selected position of operation of the screw assembly.

### Claim 17 (depends on 16)

The nebulizer of claim 16, wherein the visual indicator is one of a liquid crystal display and a light emitting diode and the visual indicator is linked to the screw assembly by an electronic circuitry such that operation of the screw assembly causes the visual indicator to display one of a range of numerical values that corresponds to the distance of movement of the moveable member for a selected position of operation of the screw assembly.

### Claim 18 (depends on 17)

The nebulizer of claim 17, wherein each of the numerical values correspond to a precalculated fluid volume to be displaced from the container by movement of the moveable member a distance based on a selected position of operation of the screw assembly.

### Claim 19 (depends on 17)

The nebulizer of claim 17, wherein the selecting of the distance of movement of the moveable member by operating the screw assembly to a selected operating position is carried out by selecting a position of operation of the screw assembly based on a displayed numerical value.

### Claim 20 (depends on 17)

The nebulizer of claim 17, further comprising a selection knob linked to the screw assembly and the visual indicator linked to the selection knob such that operation of the selection knob causes operation of the screw assembly and operation of the visual indicator.
