Ventilation mask with integrated piloted exhalation valve and method of ventilating a patient using the same

• US 9,616,194 B2
• Filed: 03/27/2012
• Issued: 04/11/2017
• Est. Priority Date: 06/22/2011
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Allum, Todd W., Cipollone, Joseph, Kassanis, George A.
• Primary Examiner(s): Ho, Tan-Uyen (Jackie) T
• Assistant Examiner(s): Boecker, Joseph D
• Application Number:
  US13/431,827
• Publication Number:
  US 20120325211A1
• Time in Patent Office: 1,841 Days
• Field of Search: 12820421, 12820423, 12820524
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• 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 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 16/207 Membrane valves with pneumatic amplification stage, i.e. having master and slave membranes
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate

Abstract

In accordance with the present invention, there is provided a mask for achieving positive pressure mechanical ventilation (inclusive of CPAP, ventilator support, critical care ventilation, emergency applications), and a method for a operating a ventilation system including such mask. The mask of the present invention includes a piloted exhalation valve that is used to achieve the target pressures/flows to the patient. The pilot for the valve may be pneumatic and driven from the gas supply tubing from the ventilator. The pilot may also be a preset pressure derived in the mask, a separate pneumatic line from the ventilator, or an electro-mechanical control. Additionally, the valve can be implemented with a diaphragm or with a flapper.

Claims

1. A method of ventilating a patient utilizing a direct nasal interface mask worn by the patient and fluidly connected to a ventilator adapted to supply a pressurized, breathable gas to the direct nasal interface mask, the method comprising the steps of:

a) providing the direct nasal interface mask with a housing defining at least one flow passage, and a piloted exhalation valve is integrated into the housing and fluidly coupled to the flow passage; and

b) applying a pilot pressure to the exhalation valve via the ventilator and in a manner which facilitates the selective movement thereof from an open position to which it is normally biased and wherein at least a portion of the flow passage is vented to ambient air, to a closed position wherein fluid flow between the flow passage and ambient air is at least partially obstructed thereby.

2. The method of claim 1 wherein step (a) comprises configuring the exhalation valve to completely obstruct fluid flow between the flow passage and ambient air when moved to the closed position in step (b).

3. The method of claim 1 wherein step (a) comprises configuring the exhalation valve to vent the entirety of the flow passage to ambient air when moved to the open position in step (b).

4. The method of claim 1 wherein step (a) comprises configuring the exhalation valve to adjust fluid flow between the flow passage and ambient air when disposed between the closed position and open position in step (b).

5. The method of claim 1 wherein step (a) comprises configuring the housing to include a pressure sensing port, and step (b) comprises sensing pressure within the flow passage through the use of the pressure sensing port to facilitate at least one of achieving and monitoring a therapeutic pressure level therein.

6. The method of claim 1 wherein step (a) comprises configuring the exhalation valve to include a diaphragm which is movable between the closed and open positions in step (b).

7. The method of claim 1 wherein step (a) comprises configuring the exhalation valve to include at least one flapper which is movable between the closed and open positions in step (b).

8. The method of claim 1 wherein step (b) comprises initially supplying no pressurized, breathable gas from the ventilator to the patient via the direct nasal interface mask.

9. The method of claim 8 further comprising the step of:

c) initiating the delivery of the pressurized, breathable gas from the ventilator to the patient at a prescribed therapeutic pressure level upon an occurrence of a predetermined event.

10. The method of claim 9 wherein the predetermined event of step (c) is at least one of:

an elapse of a set time interval;

a detection of a patient breathing pattern indicative of an airway obstruction in the patient; and

a detection of a patient breathing pattern indicative of the patient falling asleep.

11. A method of ventilating a patient using a direct nasal interface mask worn by the patient and fluidly connected to a ventilator adapted to supply a pressurized, breathable gas to the direct nasal interface mask, the method comprising the steps of:

a) providing the direct nasal interface mask with a housing at least partially defining a valve chamber which fluidly communicates with ambient air, a pilot port which fluidly communicates with the valve chamber, at least one flow passage which is selectively placeable into fluid communication with the valve chamber, and a diaphragm which is disposed within the valve chamber and selectively movable from an open position to which it is normally biased and wherein the flow passage is vented to ambient air via the valve chamber, to a closed position wherein fluid flow between the flow passage and the valve chamber is obstructed thereby; and

b) using the pilot port to selectively apply a pilot pressure from the ventilator to the diaphragm in a manner facilitating the movement thereof to the closed position.

12. The method of claim 11 wherein step (a) comprises configuring the housing to include a pressure sensing port which fluidly communicates with the flow passage, and step (b) comprises sensing pressure within the flow passage through the use of the pressure sensing port to facilitate at least one of achieving and monitoring a therapeutic pressure level therein.

13. The method of claim 11 wherein step (b) further comprises initially supplying no pressurized, breathable gas from the ventilator to the patient via the direct nasal interface mask, and initially supplying no pilot pressure from the ventilator to the diaphragm.

14. The method of claim 13 further comprising the step of:

c) initiating the delivery of the pressurized, breathable gas from the ventilator to the patient at a prescribed therapeutic pressure level upon an occurrence of a predetermined event.

15. The method of claim 14 wherein the predetermined event of step (c) is at least one of:

(i) an elapse of a set time interval;

(ii) a detection of a patient breathing pattern indicative of an airway obstruction in the patient; and

(iii) a detection of a patient breathing pattern indicative of the patient falling asleep.

16. The method of claim 13 further comprising the steps of:

c) initiating the delivery of the pressurized, breathable gas from the ventilator to the direct nasal interface mask through the use of tubing having an inner diameter in the range of from about 1 mm to about 9 mm; and

d) delivering the pressurized, breathable gas from the ventilator to the direct nasal interface mask through the tubing at a delivery pressure level which exceeds a prescribed therapeutic pressure level for the delivery of the pressurized, breathable gas from the direct nasal interface mask to the patient.