Delivery of aerosol medications for inspiration

• US 5,826,570 A
• Filed: 04/23/1997
• Issued: 10/27/1998
• Est. Priority Date: 03/05/1991
• Status: Expired due to Fees

• Current Assignee: Aradigm Corporation
• Original Assignee: Aradigm Corporation
• Inventors: Rubsamen, Reid M., Goodman, David E.
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US08/847,327
• Time in Patent Office: 552 Days
• Field of Search: 128/200.14, 128/200.16, 128/200.23, 128/203.12, 128/204.21, 128/204.23, 128/205.23
• US Class Current: 128/200.14
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61M 11/002 by flow deviation causing inertial separation of transported particles
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 2205/6036 characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8212 : with means or measures taken for minimising energy consumption
• CPC Class Codes: B01F 23/2132 : using nozzles
• CPC Class Codes: B01F 35/71 : Feed mechanisms with proportioning B01F35/80
• CPC Class Codes: B01F 35/711 : for feeding a mixture of components, i.e. solids in liquid, solids in a gas stream
• CPC Class Codes: B01F 35/7179 : using sprayers, nozzles or jets
• CPC Class Codes: F16H 35/00 : Gearings or mechanisms with other special functional features
• CPC Class Codes: G01F 1/363 : with electrical or electro-mechanical indication G01F1/37 and G01F1/38 take precedence
• CPC Class Codes: G01F 1/40 : Details of construction of the flow constriction devices
• CPC Class Codes: G01F 1/44 : Venturi tubes
• CPC Class Codes: G01F 1/50 : Correcting or compensating means
• CPC Class Codes: G01F 13/006 : measuring volume in function of time
• CPC Class Codes: G01F 15/002 : for gases
• CPC Class Codes: G01F 25/10 : of flowmeters
• CPC Class Codes: G01F 7/005 : by measuring pressure or differential pressure, created by the use of flow constriction

Abstract

Apparatus and methods for delivering an amount of aerosolized medicine for inspiration by a patient in response to the occurrence of appropriate delivery point or points in the patient'"'"'s detected breath flow. The aerosol medication may be administered as one or more pulses having a pulse width, shape, and frequency that will maximize the respirable fraction of the aerosolized compound being administered. The delivery point or points may be predetermined or determined from a prior inspiratory flow for depositing the selected medication at one or more desired locations in the patient'"'"'s airway. Determined delivery points are recursively lowered for each inspiratory flow that does not satisfy one of the predetermined and previously lowered threshold. Changes in the patient'"'"'s breath flow patterns during the course of an aerosolized medication inspiration therapy program may be detected and used to adjust the controlled amount of medication to be delivered in a given administration and/or to inform the patient of the patient'"'"'s condition or change in condition. The device also may contain a library of administration protocols or operating parameters for different medications and a means for identifying from the canister the medicinal contents of the canister for customizing operation of the apparatus.

Claims

1. A drug delivery canister, comprising:

a cylindrical container having a valved opening therein which valve prevents release of container contents until actuated;

a pressurized formulation of a pharmaceutically active drug and pharmaceutically acceptable carrier in the container; and

a resistor having a set resistance value wherein the resistor identifies the pharmaceutically active drug.

2. The canister of claim 1 wherein the resistor identifies a method of administration of the formulation in the canister.

3. The canister of claim 2, wherein the method of administration comprises release of the formulation from the canister in an aerosol with desired particle size distribution for favorable deposition into desired locations in a patient'"'"'s pulmonary system.

4. The canister of claim 1, wherein the resistor identifies a method of release of formulation from the canister so as to obtain a desired delivery characteristic.

5. The canister of claim 1, further comprising:

a battery supply unit and electrodes for corresponding with electrodes on a device to which power is to be supplied.

6. A hand held device for delivering an aerosolized medication to a patient for inspiration, comprising:

a tube forming a flow path from an open end to a mouth end;

a canister comprising

a cylindrical container having a valved opening therein which valve prevents release of container contents until actuated;

a pressurized formulation of a pharmaceutically active drug and pharmaceutically acceptable carrier in the container;

a resistor having a set resistance value wherein the resistor identifies the pharmaceutically active drug;

a nozzle for releasing and aerosolizing medication from the canister to the open end of the tube;

a flow transducer for measuring the patient'"'"'s breath flow through the tube;

a microprocessor for calculating a medication delivery point based on information from the flow transducer; and

an actuating mechanism which initiates release of medication through the nozzle and into the tube upon receipt of a signal sent after the microprocessor has determined that the patient'"'"'s breath flow is at the delivery point.

7. The device of claim 6 wherein the delivery point is calculated to maximize the efficacy of the medication.

8. The device of claim 7, further comprising:

a means for detecting breath parameters of the patient including inspiratory flow and expiratory flow.

9. The device of claim 8, further comprising:

a visual indicator providing a visual display of detected breath parameters.

10. The device of claim 6, wherein the microprocessor includes a library of administration protocols for different medications.

11. The device of claim 6, further comprising:

a battery supply and electrodes electrically connected thereto.