Ventilation mask with integrated piloted exhalation valve

• US 9,327,092 B2
• Filed: 03/04/2013
• Issued: 05/03/2016
• 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: Brambilla, Enrico
• Primary Examiner(s): Douglas, Steven
• Application Number:
  US13/784,561
• Publication Number:
  US 20130184602A1
• Time in Patent Office: 1,156 Days
• Field of Search: 128/207.13, 128/201.13, 128/205.24, 128/207.18, 128/204.18
• US Class Current: 1/1
• 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 ventilation mask, comprising:

a housing sized and configured to be positionable between a patient'"'"'s nose and mouth in contact with the patient'"'"'s nose, the housing defining an internal fluid chamber, at least one gas delivery lumen which fluidly communicates with the fluid chamber, and a valve pilot lumen; and

a piloted exhalation valve attached to the housing and at least partially residing within the fluid chamber thereof, the exhalation valve comprising;

a valve housing defining a valve chamber which fluidly communicates with the fluid chamber, the pilot lumen and ambient air; and

a diaphragm disposed within the valve chamber, the diaphragm normally being biased to an open position wherein the fluid chamber fluidly communicates with ambient air via the valve chamber, and a closed position wherein fluid communication between the fluid chamber and ambient air is blocked thereby, the movement of the diaphragm from the open position to the closed position being facilitated by the selective pressurization of at least a portion of the valve chamber via the pilot lumen.

2. The ventilation mask of claim 1 wherein the housing further defines a pressure sensing lumen which fluidly communicates with the fluid chamber.

3. The ventilation mask of claim 1 wherein the housing is a resilient cushion including a spaced pair of hollow pillow portions which each fluidly communicate with the fluid chamber and are adapted to engage respective ones of the nostrils of the patient'"'"'s nose.

4. The ventilation mask of claim 3 further comprising a heat and moisture exchanger disposed within the fluid chamber between the exhalation valve and the pillow portions of the cushion.

5. The ventilation mask of claim 3 wherein the valve housing comprises:

a seat member; and

a cap member attached to the seat member, the seat and cap members collectively defining the valve chamber;

the diaphragm being captured between the seat and cap members in a manner wherein the diaphragm effectively segregates the valve chamber into a pilot section which fluidly communicates with the pilot lumen and an exhaust section which fluidly communicates with the fluid chamber in ambient air.

6. The ventilation mask of claim 5 wherein the diaphragm and the seat member define complimentary seating surfaces which are sized and configured relative to each other such that the movement of the diaphragm to the closed position facilitates the placement of the seating surfaces into sealed engagement with each other in a manner blocking fluid communication between the fluid chamber and ambient air.

7. The ventilation mask of claim 6 wherein the seat member includes a plurality of vents which are disposed therein and collectively define a fluid conduit between the fluid chamber and the exhaust section of the valve chamber.

8. The ventilation mask of claim 7 wherein the vents of the seat member reside within the fluid chamber of the cushion.

9. The ventilation mask of claim 8 further comprising a shield plate attached to the cushion and partially defining the fluid chamber, the shield plate including an opening therein which is sized and configured to accommodate a portion of the seat member.

10. The ventilation mask of claim 9 further comprising a reinforcement frame member which is attached to the cushion, the frame member spanning the shield plate and including an opening therein which is coaxially aligned with the opening of the shield plate and is size and configured to accommodate a portion of the seat member.

11. A ventilation mask, comprising:

a housing sized and configured to be positionable between a patient'"'"'s nose and mouth in contact with the patient'"'"'s nose, the housing defining an internal fluid chamber; and

an exhalation valve attached to the housing and at least partially residing within the fluid chamber thereof, the exhalation valve comprising;

a valve housing defining a valve chamber which fluidly communicates with the fluid chamber via at least one vent and with ambient air via at least one outlet conduit; and

a diaphragm disposed within the valve chamber, the diaphragm being selectively movable between an open position wherein the fluid chamber fluidly communicates with ambient air via the valve chamber, and a closed position wherein fluid communication between the fluid chamber and ambient air is blocked thereby;

the vent of the valve housing residing and being enclosed within the fluid chamber, with the outlet conduit of the valve housing protruding from the fluid chamber.

12. The ventilation mask of claim 11 wherein the housing is a resilient cushion including a spaced pair of hollow pillow portions which each fluidly communicate with the fluid chamber and are adapted to engage respective ones of the nostrils of a patient'"'"'s nose.

13. The ventilation mask of claim 12 further comprising a heat and moisture exchanger disposed within the fluid chamber between the exhalation valve and the pillow portions of the cushion.

14. The ventilation mask of claim 12 wherein the valve housing comprises:

a seat member defining the vent and the outlet conduit; and

a cap member attached to the seat member, the seat and cap members collectively defining the valve chamber;

the diaphragm being captured between the seat and cap members in a manner wherein the diaphragm effectively segregates the valve chamber into at least two sections, one of which fluidly communicates with the vent and the outlet conduit.

15. The ventilation mask of claim 14 wherein the diaphragm and the seat member define complimentary seating surfaces and are sized and configured relative to each other such that the movement of the diaphragm to the closed position facilitates the placement of the seating surfaces into sealed engagement with each other in a manner blocking fluid communication between the vent and the outlet conduit.

16. The ventilation mask of claim 15 wherein the seat member includes a plurality of vents which collectively define a fluid conduit.

17. The ventilation mask of claim 15 further comprising a shield plate attached to the cushion and partially defining the fluid chamber, the shield plate including an opening therein which is sized and configured to accommodate a portion of the seat member which defines the outlet conduit thereof.

18. The ventilation mask of claim 17 further comprising a reinforcement frame member which is attached to the cushion, the frame member spanning the shield plate and including an opening therein which is coaxially aligned with the opening of the shield plate and is sized and configured to accommodate the portion of the seat member which defines the outlet conduit thereof.

19. A ventilation mask, comprising:

a housing sized and configured to be positionable between a patient'"'"'s nose and mouth in contact with the patient'"'"'s nose, the housing defining an internal fluid chamber, at least one gas delivery lumen which fluidly communicates with the fluid chamber, and a valve pilot lumen; and

an exhalation valve at least partially residing within the fluid chamber of the housing, the exhalation valve including;

a valve chamber which fluidly communicates with the fluid chamber, the pilot lumen and ambient air; and

a diaphragm which is disposed within the valve chamber, the diaphragm being movable between an open position wherein the fluid chamber fluidly communicates with ambient air via the valve chamber, and a closed position wherein fluid communication between the fluid chamber and ambient air is blocked thereby;

the movement of the diaphragm from the open position to the closed position being facilitated by the selective pressurization of at least a portion of the valve chamber via the pilot lumen.

20. The ventilation mask of claim 19 wherein the housing further defines a pressure sensing lumen which fluidly communicates with the fluid chamber.