Ventilation mask with integrated piloted exhalation valve

• US 8,844,533 B2
• Filed: 03/02/2012
• Issued: 09/30/2014
• 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, Brambilla, Enrico, Cipollone, Joseph
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/411,348
• Publication Number:
  US 20120325205A1
• Time in Patent Office: 942 Days
• Field of Search: 128/207.13, 128/201.13, 128/205.24, 128/207.18, 128/204.18
• US Class Current: 128/207.13
• 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

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 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. The mask of the present invention may further include a heat and moisture exchanger (HME) which is integrated therein.

Claims

1. A nasal pillows mask, comprising:

a cushion defining at least one flow passage and a valve pilot lumen; and

an exhalation valve cooperatively engaged to the cushion and fluidly coupled to the flow passage;

the exhalation valve being piloted and selectively movable between a closed position wherein fluid flow between the flow passage and ambient air is at least partially obstructed thereby, and an open position wherein at least a portion of the flow passage is vented to ambient air, the valve pilot lumen being adapted to selectively apply a pilot fluid pressure to the exhalation valve in a manner facilitating the movement thereof to the closed position.

2. The nasal pillows mask of claim 1 wherein the exhalation valve is configured to completely obstruct fluid flow between the flow passage and ambient air when in the closed position.

3. The nasal pillows mask of claim 1 wherein the exhalation valve is configured to vent the entirety of the flow passage to ambient air when in the open position.

4. The nasal pillows mask of claim 1 wherein the exhalation valve is configured to adjust fluid flow between the flow passage and ambient air when disposed between the closed position and open position.

5. The nasal pillows mask of claim 1 wherein the exhalation valve is configured to be normally biased to the open position.

6. The nasal pillows mask of claim 5 wherein the exhalation valve comprises a diaphragm which is fabricated from a resilient material and movable between the closed and open positions.

7. The nasal pillows mask of claim 6 wherein:

the exhalation valve defines a valve chamber; and

the diaphragm resides within the valve chamber and is sized and configured relative thereto such that the valve chamber is maintained in constant fluid communication with ambient air and the valve pilot lumen, is placed into fluid communication with the flow passage when the diaphragm is in the open position, and is substantially fluidly isolated from the flow passage when the diaphragm is in the closed position.

8. The nasal pillows mask of claim 7 wherein:

the exhalation valve comprises a seat member and a cap member which are attached to each other and collectively define the valve chamber thereof;

the seat member defines a fluid conduit between the valve chamber and the flow passage; and

the diaphragm is configured to establish and maintain a sealed engagement with the seat member when in the closed position in a manner substantially blocking the fluid conduit.

9. The nasal pillows mask of claim 8 wherein the seat member further includes a plurality of exhaust vents which are formed therein and fluidly communicate with the valve chamber.

10. The nasal pillows mask of claim 1 further comprising a heat and moisture exchanger disposed within the flow passage.

11. A nasal pillows mask, comprising:

a cushion defining an internal fluid chamber, a valve pilot lumen, a pair of pillow portions which each fluidly communicate with the fluid chamber, and at least one gas delivery lumen which fluidly communicates with the fluid chamber; and

an exhalation valve cooperatively engaged to the cushion in a manner wherein the valve pilot lumen is fluidly coupled thereto, the exhalation valve being fluidly coupled to the fluid chamber;

the exhalation valve being piloted, and selectively movable between a closed position wherein fluid flow between the fluid chamber and ambient air is at least partially obstructed thereby, and an open position wherein at least a portion of the fluid chamber is vented to ambient air.

12. The nasal pillows mask of claim 11 wherein the cushion further defines a pressure sensing lumen which fluidly communicates with the fluid chamber.

13. The nasal pillows mask of claim 12 further comprising a heat and moisture exchanger disposed within the fluid chamber of the cushion proximate the pillow portions thereof.

14. The nasal pillows mask of claim 11 wherein the exhalation valve comprises a diaphragm which is movable between the closed and open positions, and is normally biased to the open position.

15. The nasal pillows mask of claim 14 wherein:

the exhalation valve defines a valve chamber; and

the diaphragm resides within the valve chamber and is sized and configured relative thereto such that the valve chamber is maintained in constant fluid communication with ambient air and the valve pilot lumen, is placed into fluid communication with the fluid chamber when the diaphragm is in the open position, and is substantially fluidly isolated from the flow passage when the diaphragm is in the closed position.

16. The nasal pillows mask of claim 15 wherein:

the exhalation valve comprises a seat member and a cap member which are attached to each other and collectively define the valve chamber thereof;

the seat member defines a fluid conduit between the valve chamber and the fluid chamber; and

the diaphragm is configured to establish and maintain a sealed engagement with the seat member when in the closed position in a manner substantially blocking the fluid conduit.

17. The nasal pillows mask of claim 16 wherein the seat member further includes a plurality of exhaust vents which are formed therein and fluidly communicate with the valve chamber.

18. A nasal pillows mask, comprising:

a cushion defining an internal fluid chamber, a valve pilot lumen, and at least one gas delivery lumen which fluidly communicates with the fluid chamber;

a heat and moisture exchanger disposed within the fluid chamber of the cushion and configured to provide an increased measure of elasticity thereto; and

an exhalation valve cooperatively engaged to the cushion in a manner wherein the valve pilot lumen is fluidly coupled thereto, the exhalation valve being fluidly coupled to the fluid chamber;

the exhalation valve being piloted, and selectively movable between a closed position wherein fluid flow between the fluid chamber and ambient air is at least partially obstructed thereby, and an open position wherein at least a portion of the fluid chamber is vented to ambient air.

19. The nasal pillows mask of claim 18 wherein the exhalation valve comprises a diaphragm which is movable between the closed and open positions, and is normally biased to the open position.