Device and method for directing aerosolized mist to a specific area of the respiratory tract

• US 5,906,202 A
• Filed: 11/21/1996
• Issued: 05/25/1999
• Est. Priority Date: 11/21/1996
• Status: Expired due to Fees

• Current Assignee: Aradigm Corporation
• Original Assignee: Aradigm Corporation
• Inventors: Schuster, Jeffrey A., Gonda, Igor
• Primary Examiner(s): Asher, Kimberly L.
• Application Number:
  US08/752,946
• Time in Patent Office: 915 Days
• Field of Search: 128/203.12, 128/203.14, 128/203.21, 128/203.23, 128/203.24
• US Class Current: 128/203.23
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 16/1075 by influencing the temperature A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/142 with semi-permeable walls separating the liquid from the respiratory gas
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient

Abstract

Methodology and devices for delivering aerosolized formulation to target areas of a patient'"'"'s respiratory tract are disclosed. The device is a hand-held, self-contained unit which is readily portable and capable of measuring a variety of parameters including the patient'"'"'s total respiratory tract capacity, inspiratory flow rate and inspiratory volume. The device is loaded with a container which includes a drug formulation in a liquid form which container includes an opening which is covered, at least in part, by a porous membrane. The pore sizes are designed so as to provide aerosolized particle sizes which are tailored in size for delivery to the specific target area of the respiratory tract. The device can allow the patient to inhale a predetermined volume of unaerosolized air followed by a predetermined volume of aerosol after which flow can be shut off completely or followed by additional aerosol free air. By precisely determining the particle size of the aerosols in combination with precisely determining the volume of aerosol and aerosol free air allowed into the respiratory tact it is possible to target a particular area of the respiratory tract and medicate that area with effective treatment of formulations. In certain circumstances it may be desirable to heat the air surrounding aerosolized particles in order to evaporate away a liquid carrier resulting in particles of a desired size range for delivery to the particular target area of the respiratory tract.

Claims

1. A method for delivering a volume of aerosol to a target area of a lung, comprising:

(a) drawing particle free air through a channel;

(b) measuring a volume of particle free air inhaled into the lungs of the patient;

(c) continuing to draw air wherein the air is drawn over a surface of a porous membrane having pores with a diameter in the range of about 0.5 to about 4.0 microns;

(d) forcing formulation comprised of a pharmaceutically active drug and a carrier through the pores of the membrane to create a volume of aerosol;

(e) drawing a measured volume of aerosol through the channel and into the respiratory tract of the patient;

(f) preventing further flow through the channel; and

(g) repeating steps (a)-(f) using a new disposable membrane in each step (c);

wherein the membrane is flexible and the forcing is carried out with sufficient force as to protrude the flexible membrane outward in a convex configuration away from the formulation and toward the air drawn through the channel; and

further wherein the flexible membrane protrudes outward beyond a boundary layer of air flow created in the channel and the air is drawn over the protruded membrane to a channel end, via a substantially linear flow path.

2. The method of claim 1, further comprising:

(h) inhaling additional particle free air into the respiratory tract of the patient after the measured volume of aerosol is inhaled.

3. The method of claim 2, wherein the additional particle free air is inhaled in a volume sufficient to fill the upper region of the patient'"'"'s respiratory tract.

4. The method of claim 1, wherein the measured volume (b) of particle free air inhaled into the respiratory tract is equal to a volume in the range of about 20% to 40% of the patient'"'"'s total respiratory tract volume.

5. The method of claim 1, wherein the volume of aerosol (d) inhaled into the patient'"'"'s respiratory tract is a volume in the range of 50 cc to 400 cc.

6. The method of claim 1, wherein the total amount of particle free air and aerosol drawn into the patient'"'"'s respiratory tract is equal to a volume in the range of 60% to 80% of the patient'"'"'s total respiratory tract volume.

7. The method of claim 1, further comprising:

heating the aerosol in an amount sufficient to evaporate away carrier from the pharmaceutically active drug; and

inhaling a volume of particle free air equal to a volume in the range of 20% to 40% of the patient'"'"'s total respiratory tract volume prior to inhaling the volume of aerosol.

8. The method of claim 1, wherein further flow through the channel is prevented (f) mechanically by means of a valve.

9. The method of claim 1, wherein further flow through the channel is prevented (f) by a signal means which signal prompts the patient to halt inhalation.

10. The method of claim 1, wherein the drug is a respiratory drug.

11. The method of claim 1, wherein the drug comprises genetic material which expresses a therapeutically effective peptide.

12. The method as claims in claim 11, wherein the genetic material comprises a biologically active endonuclease.

13. The method as claimed in claim 11, wherein the genetic material is DNAse.

14. The method of claim 1, wherein the forcing occurs at an inspiratory flow rate in the range of about 0.10 to about 4.0 liters/second and an inspiratory volume in the range of about 0.15 to about 3.0 liters, the method further comprising:

adding energy to the aerosolized particles by actively heating air brought into contact with the particles; and

inhaling the particles into the respiratory tract of a patient;

wherein energy is added in an amount such that 50% or more of the carrier in the particles when formed is evaporated prior to the particles reaching the patient and wherein the energy is added by actively heating air by moving air through a heated material which material is heated prior to the patient'"'"'s inhalation.