Aerosol delivery apparatus and method for pressure-assisted breathing systems

• US 7,267,121 B2
• Filed: 09/30/2004
• Issued: 09/11/2007
• Est. Priority Date: 04/20/2004
• Status: Active Grant

• Current Assignee: Novartis Ag
• Original Assignee: Aerogen, Inc. (Nektar Therapeutics)
• Inventors: Ivri, Ehud
• Primary Examiner(s): Yu; Justine R.
• Assistant Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US10/957,321
• Publication Number:
  US 20050229929A1
• Time in Patent Office: 1,076 Days
• Field of Search: 128/200.16, 128/203.12, 128/204.18, 128/204.23, 128/200.14, 128/200.21, 128/203.16, 128/203.17, 128/203.22, 128/203.24, 128/204.14
• US Class Current: 128/203.17
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/08 Bellows; Connecting tubes having means for taking samples G01N1/22; Water traps; Patient circuits
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0033 electrical
• CPC Class Codes: A61M 2205/7518 bacterial

Abstract

A pressure-assisted breathing system is provided that comprises: a pressure-generating circuit for maintaining a positive pressure within the system; a patient interface device coupled to a patient'"'"'s respiratory system; a respiratory circuit for providing gas communication between the pressure-generating circuit and the patient interface device; means for introducing aerosol particles into the gas flow in the respiratory circuit; and means for discontinuing the introduction of aerosol particles into said respiratory circuit gas flow when the patient exhales. In one embodiment, a flow sensor is disposed in an auxiliary circuit in fluid communication with the respiratory circuit and electronically coupled with a nebulizer. The flow sensor is adapted to detect changes in the volumetric flow rate of gas in the auxiliary circuit when the patient exhales and stops exhaling and sends corresponding electronic signals to the nebulizer to turn off and turn on, respectively.

Claims

1. A CPAP apparatus for the delivery of an aerosolized medicament to a patient'"'"'s respiratory system comprising:

a pressure-generating circuit that maintains continuous positive pressure throughout the apparatus during the breathing cycle of the patient;

a patient interface device adapted to be coupled to a patient'"'"'s respiratory system;

a respiratory circuit that provides gas communication between the pressure-generating circuit and the patient interface device, whereby the patient breathes gas under continuous positive pressure;

a nebulizer that introduces aerosolized medicament into the gas flow in the respiratory circuit;

an auxiliary circuit in gas communication with the respiratory circuit whereby a portion of the gas flow in the respiratory circuit is diverted to the external atmosphere to provide a secondary gas flow;

a flow sensor disposed in the auxiliary circuit for measuring the flow rate of the secondary gas flow; and

electronic circuitry connecting the flow sensor to the nebulizer, whereby the flow sensor sends a first electronic signal that causes the nebulizer to turn off when the flow sensor detects an increase in the flow rate of the secondary gas flow as the result of the patient commencing exhalation.

2. Apparatus according to claim 1 wherein the flow sensor sends a second signal that causes the nebulizer to turn on when the flow sensor detects a decrease in the flow rate of the secondary gas flow as the result of the patient ceasing exhalation.

3. Apparatus according to claim 2 wherein each signal is a certain output voltage generated by the flow sensor.

4. Apparatus according to claim 1 wherein the flow sensor is adapted to measure a range of flow rates less than the flow rate of the secondary gas flow;

and further comprising a valve disposed in the auxiliary circuit for reducing the flow rate of the secondary gas flow to the measurement range of the flow sensor.

5. Apparatus according to claim 4 wherein the flow sensor has a flow range of 0 to 1 L/min and the valve regulates the flow of gas to about the middle of said range.

6. Apparatus according to claim 1 further comprising a disposable filter for trapping contaminants prior to passing through the flow sensor.

7. Apparatus according to claim 1 wherein the nebulizer comprises a reservoir for holding a liquid medicament to be delivered to the patient'"'"'s respiratory system, a vibrating aperture-type aerosol generator for aerosolizing the liquid medicament and a connector for connecting the nebulizer to the respiratory circuit so as to entrain the aerosolized medicament from the aerosol generator into the gas flowing through the respiratory circuit.

8. Apparatus according to claim 7 wherein said liquid medicament is a surfactant.

9. A method of delivering an aerosol to a patient'"'"'s respiratory system which comprises the steps of:

providing a CPAP system having a pressure-generating circuit that provides continuous positive pressure throughout the apparatus during the breathing cycle of the patient, a respiratory circuit coupled to a patient interface device whereby the patient breathes gas under continuous positive pressure and an auxiliary circuit in gas communication with the respiratory circuit that diverts a portion of the gas flow in the respiratory circuit to the external atmosphere to provide a secondary gas flow, the auxiliary circuit having disposed therein a flow sensor electronic ally connected to a nebulizer coupled to the respiratory circuit;

introducing a liquid into the nebulizer;

regulating the flow rate of the secondary gas flow to a range that can be measured by the flow sensor; and

turning on the nebulizer to introduce an aerosol of the liquid into the respiratory circuit, or turning off the nebulizer to cease introduction of aerosol into the respiratory circuit, in response to at least one change in the flow rate of secondary gas flow that the flow sensor detects in the auxiliary circuit.

10. A pressure-assisted breathing system comprising:

a pressure-generating circuit for maintaining a positive pressure throughout the apparatus during the breathing cycle of a patient;

a patient interface device adapted to be coupled to the patient'"'"'s respiratory system;

a respiratory circuit for providing gas communication between the pressure-generating circuit and the patient interface device, whereby the patient breathes gas under continuous positive pressure;

an auxiliary circuit in fluid communication with the respiratory circuit that diverts a portion of the reduced gas flow in the respiratory circuit to the external atmosphere to provide a secondary gas flow;

means for introducing aerosol particles into the gas flow in the respiratory circuit;

a flow sensor disposed in the auxiliary circuit that is adapted to measure gas flow rates less than the flow rate of the secondary gas flow, wherein the flow sensor is electronically coupled with the means for introducing the aerosol particles into the respiratory circuit gas flow; and

a valve disposed in the auxiliary circuit for reducing the secondary gas flow to a flow rate that can be measured by the flow sensor;

wherein said flow sensor is adapted to detect a change in the flow rate of the secondary gas flow when the patient exhales and inhales, and thereby send a corresponding electronic signal tat causes the means for introducing aerosol particles to turn off during exhalation and turn on during inhalation.

11. A system according to claim 10 wherein the auxiliary circuit further comprises a disposable filter for trapping contaminants in the flow of gas before it passes through the flow sensor.

12. A system according to claim 10 wherein the means for introducing aerosol particles comprises a nebulizer.

13. A system according to claim 12 wherein the nebulizer comprises a reservoir for holding a liquid medicament to be delivered to the patient'"'"'s respiratory system, a vibrating aperture-type aerosol generator for aerosolizing the liquid medicament and a connector for connecting the nebulizer to the respiratory circuit so as to entrain the aerosolized medicament from the aerosol generator into the gas flowing through the respiratory circuit.