US5906202A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device and method for directing aerosolized mist to a specific area of the respiratory tract
Assignee: Aradigm Corp
•
Filing: 1996-11-21
•
Granted: 1999-05-25
•
Expires: 2016-11-21
Abstract
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.
Inventors
- 👤 Jeffrey A. Schuster
- 👤 Igor Gonda
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 07:46
CPC Classifications
A; A61; A61M; A61M15/00; A61M15/0028; A61M15/0045; A61M11/00; A61M11/001; A61M15/0046; A61M15/0051; A61M15/0065; A61M15/0068; A61M15/008; A61M15/0083; A61M16/00; A61M16/10; A61M16/14; A61M16/142; A61M15/0081; A61M16/1075; A61M16/16; A61M16/0003; A61M2016/0015; A61M2016/0018; A61M2016/0021; A61M2205/00; A61M2205/50; A61M2205/52
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
209 words
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.
Claim 2
Independent Claim
209 words
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.
Claim 3
Dependent Claim
28 words
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.
Claim 4
Dependent Claim
27 words
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.
Claim 5
Dependent Claim
39 words
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.
Claim 6
Dependent Claim
29 words
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.
Claim 7
Dependent Claim
40 words
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.
Claim 8
Dependent Claim
56 words
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.
Claim 9
Dependent Claim
20 words
The method of claim 1, wherein further flow through the channel is prevented (f) mechanically by means of a valve.
Claim 10
Dependent Claim
26 words
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.
Claim 11
Dependent Claim
12 words
The method of claim 1, wherein the drug is a respiratory drug.
Claim 12
Dependent Claim
17 words
The method of claim 1, wherein the drug comprises genetic material which expresses a therapeutically effective peptide.
Claim 13
Dependent Claim
16 words
The method as claims in claim 11, wherein the genetic material comprises a biologically active endonuclease.
Claim 14
Dependent Claim
13 words
The method as claimed in claim 11, wherein the genetic material is DNAse.
Claim 15
Dependent Claim
124 words
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.
References Cited (Backward Citations)
DE272606C
Cited
US4116387A
Cited
US4106503A
Cited
US5038769A
Cited
US4677975A
Cited
EP0358002A2
Cited
US5027806A
Cited
EP0430566A2
Cited
DE4036244A1
Cited
WO1992011050A1
Cited
FR2673142A1
Cited
US5404871A
Cited
US5450336A
Cited
US5333106A
Cited
FR2700697A1
Cited
WO1994027653A2
Cited
US5544646A
Cited
US5660166A
Cited
US5394886A
Cited
US5522385A
Cited
US5586550A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2002-05-24 | 2002-11-23 | 2003-05-25 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-05-24 | 2006-11-23 | 2007-05-25 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-05-24 | 2010-11-23 | 2011-05-25 | $7700.00 | Window Closed / Lapsed |