Devices and methods for nebulizing fluids for inhalation

• US 8,539,944 B2
• Filed: 04/08/2008
• Issued: 09/24/2013
• Est. Priority Date: 01/07/2002
• Status: Active Grant

• Current Assignee: Novartis Ag
• Original Assignee: Novartis Ag
• Inventors: Patel, Rajan, Klimowicz, Michael A.
• Primary Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US12/099,302
• Publication Number:
  US 20080184993A1
• Time in Patent Office: 1,995 Days
• Field of Search: 128/200.14, 128/200.17, 128/200.19, 128/200.21, 128/200.23, 128/203.12, 128/203.14, 128/203.15, 128/203.19, 12820323-20325, 128/203.28, 604/48, 604/59, 604/140, 604/141, 604/254, 604/275, 202/309, 202/390, 239/338
• US Class Current: 128/200.14
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0024 with an on-off output signal, e.g. from a switch
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: B05B 17/0646 Vibrating plates, i.e. plates being directly subjected to the vibrations, e.g. having a piezoelectric transducer attached thereto

Abstract

A method of delivering a nebulized fluid for inhalation, including providing an aerosol generator, providing a container containing a fluid to be nebulized, providing a reservoir in fluid communication with the container and with the aerosol generator, providing a moveable member positioned to act upon the container in a manner to elect fluid therefrom, providing a linkage mechanism operable through a range of operating positions that is coupled to the moveable member to selectively control a distance of movement of the moveable member, selecting the distance of movement of the moveable member, moving the moveable member to eject fluid from the container into the reservoir, and operating the aerosol generator to elect fluid from the reservoir as a nebulized fluid for inhalation.

Claims

1. A method of delivering a nebulized fluid for inhalation, comprising:

providing an aerosol generator;

providing a container having a tab and containing a fluid to be nebulized;

providing a reservoir assembly having a detent, comprising;

a reservoir in fluid communication with the aerosol generator; and

a cannula in fluid communication with the reservoir and the container;

wherein the reservoir assembly engages the container by interlocking the detent and the tab to hold together the container and the reservoir assembly,

providing a moveable member positioned to act upon the container in a manner to eject fluid therefrom;

providing a linkage mechanism operable through a range of operating positions that is coupled to the moveable member to selectively control a distance of movement of the moveable member;

selecting the distance of movement of the moveable member;

moving the moveable member to eject fluid from the container into the reservoir; and

operating the aerosol generator to eject fluid from the reservoir as a nebulized fluid for inhalation.

2. 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.

3. The method of claim 1, wherein the linkage mechanism comprises:

a dosing mechanism,

a screw mechanism, and

an actuator,

wherein the moveable member comprises a plunger,

wherein the dosing mechanism, the screw mechanism, the actuator, and the plunger together form a titration mechanism,

wherein the plunger is movable along a longitudinal axis within the titration mechanism,

wherein the actuator is movable a fixed distance X along the longitudinal axis defined by the plunger, and

wherein the dosing mechanism is rotatable in a plane substantially perpendicular to the longitudinal axis;

wherein the container comprises a vial mechanism, comprising;

a vial, the vial having a longitudinal axis; and

a movable seal movable along the longitudinal axis of the vial;

and further comprising;

inserting the vial mechanism into a housing coupled to 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 of travel Y of the plunger corresponding to the selected dose the proviso that longitudinal travel of the plunger is not imparted;

moving the actuator longitudinally the fixed distance X to move the plunger longitudinally the selected variable distance Y to move a movable stopper the variable distance Y; and

displacing a volume of liquid, corresponding to the selected dose, from the vial to contact the aerosol generator.

4. The method of claim 3, wherein the aerosol generator comprises:

an aerosolization element having a first face and a second face, each face having a plurality of apertures therethrough,

wherein operating the aerosol generator comprises vibrating the aerosolization element.

5. The method of claim 3, further comprising coupling the reservoir to the aerosol generator, wherein the volume of liquid is displaced from the vial into the reservoir to contact the aerosol generator.

6. The method of claim 1,

wherein the moveable member comprises a longitudinally moveable plunger, movement thereof defining a longitudinal axis,

wherein the linkage mechanism comprises:

a longitudinally moveable actuator to move the plunger, movement of the actuator being along the longitudinal axis;

a screw mechanism to set a distance of travel of the plunger; and

a rotatably mounted dosing mechanism, rotation thereof defining an axis of rotation; and

wherein the container comprises a vial mechanism, comprising;

a vial along the longitudinal axis; and

a moveable seal being moveable along the longitudinal axis.

7. The method of claim 6, further comprising:

providing a controller to control operation of the aerosol generator;

placing the vial mechanism within a housing coupled to 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.