Ventilation mask with integrated piloted exhalation valve

• US 8,839,791 B2
• Filed: 03/02/2012
• Issued: 09/23/2014
• 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:
  US13/411,407
• Publication Number:
  US 20120325206A1
• Time in Patent Office: 935 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

In accordance with the present disclosure, 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 disclosure 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 disclosure may further include a heat and moisture exchanger (HME) which is integrated therein.

Claims

1. A respiratory assistance system, comprising:

a flow generator;

a nasal pillows mask including a piloted exhalation valve; and

a fluid conduit fluidly coupling the flow generator to the nasal pillows mask, and comprising;

a tri-lumen tube defining a gas delivery lumen, a valve pilot lumen and a pressure sensing lumen which are each fluidly coupled to the flow generator;

a first bi-lumen tube defining a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the tri-lumen tube and the nasal pillows mask, and a pressure sensing lumen which is fluidly coupled to and extends between the pressure sensing lumen of the tri-lumen tube and the nasal pillows mask; and

a second bi-lumen tube defining a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the tri-lumen tube and the nasal pillows mask, and a valve pilot lumen which is fluidly coupled to and extends between the valve pilot lumen of the tri-lumen tube and the nasal pillows mask.

2. The respiratory assistance system of claim 1 wherein the tri-lumen tube is fluidly coupled to a Y-connector which bifurcates the gas delivery lumen of the tri-lumen tube and facilitates the fluid coupling thereof to the gas delivery lumens of the first and second bi-lumen tubes, facilitates the fluid coupling of the pressure sensing lumens of the tri-lumen tube and the first bi-lumen tube to each other, and facilitates the fluid coupling of the valve pilot lumens of the tri-lumen tube and the second bi-lumen tube to each other.

3. The respiratory assistance system of claim 2 wherein the nasal pillows mask comprises:

a cushion defining an internal fluid chamber, a valve pilot lumen which is fluidly connected to the valve pilot lumen of the second bi-lumen tube, a pair of pillow portions which each fluidly communicate with the fluid chamber, a pair of gas delivery lumens which each fluidly communicate with the fluid chamber and are fluidly connected to respective ones of the gas delivery lumens of the first and second bi-lumen tubes, and a pressure sensing lumen which fluidly communicates with the fluid chamber and is fluidly connected to the pressure sensing lumen of the first bi-lumen tube;

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

4. The respiratory assistance system of claim 3 further comprising a heat and moisture exchanger disposed within the fluid chamber of the cushion proximate the pillow portions thereof.

5. The respiratory assistance system of claim 3 wherein the exhalation valve comprises a diaphragm which is movable between the closed and open positions, and is normally biased to the open position.

6. The respiratory assistance system of claim 5 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 of the cushion, 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.

7. The respiratory assistance system of claim 1 wherein:

the gas delivery lumen of the tri-lumen tube and the gas delivery lumens of the first and second bi-lumen tubes are each provided with an inner diameter in the range of from about 2 mm to 15 mm; and

the pressure sensing and valve pilot lumens of the tri-lumen tube, the pressure sensing lumen of the first bi-lumen tube, and the valve pilot lumen of the second bi-lumen tube are each provided with an inner diameter in the range of from about 0.5 mm to 2 mm.

8. The respiratory assistance system of claim 7 wherein the gas delivery lumen of the tri-lumen tube and the gas delivery lumens of the first and second bi-lumen tubes are each provided with an inner diameter in the range of from about 4 mm to 10 mm.

9. The respiratory assistance system of claim 7 wherein the tri-lumen tube is provided with an outer diameter of less than about 17 mm, and a length of about 2 m.

10. A respiratory assistance system, comprising:

a flow generator;

a nasal pillows mask including a piloted exhalation valve; and

a fluid conduit fluidly coupling the flow generator to the nasal pillows mask, and comprising;

a main bi-lumen tube defining a gas delivery lumen and a pressure sensing lumen which are each fluidly coupled to the flow generator;

a first bi-lumen tube defining a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the main bi-lumen tube and the nasal pillows mask, and a pressure sensing lumen which is fluidly coupled to and extends between the pressure sensing lumen of the main bi-lumen tube and the nasal pillows mask; and

a second bi-lumen tube defining a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the main bi-lumen tube and the nasal pillows mask, and a valve pilot lumen which is fluidly coupled to and extends between the gas delivery lumen of the main bi-lumen tube and the nasal pillows mask.

11. The respiratory assistance system of claim 10 wherein the main bi-lumen tube is fluidly coupled to a Y-connector which bifurcates the gas delivery lumen of the main bi-lumen tube and facilitates the fluid coupling thereof to the gas delivery lumens of the first and second bi-lumen tubes, facilitates the fluid coupling of the pressure sensing lumens of the main bi-lumen tube and the first bi-lumen tube to each other, and facilitates the fluid coupling of the gas delivery lumen of the main bi-lumen tube and the valve pilot lumen of the second bi-lumen tube to each other.

12. The respiratory assistance system of claim 11 wherein the nasal pillows mask comprises:

a cushion defining an internal fluid chamber, a valve pilot lumen which is fluidly connected to the valve pilot lumen of the second bi-lumen tube, a pair of pillow portions which each fluidly communicate with the fluid chamber, a pair of gas delivery lumens which each fluidly communicate with the fluid chamber and are fluidly connected to respective ones of the gas delivery lumens of the first and second bi-lumen tubes, and a pressure sensing lumen which fluidly communicates with the fluid chamber and is fluidly connected to the pressure sensing lumen of the first bi-lumen tube;

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

13. The respiratory assistance system 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 respiratory assistance system of claim 12 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 respiratory assistance system 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 of the cushion, 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 respiratory assistance system of claim 10 wherein:

the gas delivery lumen of the main bi-lumen tube and the gas delivery lumens of the first and second bi-lumen tubes are each provided with an inner diameter in the range of from about 2 mm to 10 mm; and

the pressure sensing lumen of the main bi-lumen tube, the pressure sensing lumen of the first bi-lumen tube, and the valve pilot lumen of the second bi-lumen tube are each provided with an inner diameter in the range of from about 0.5 mm to 2 mm.

17. The respiratory assistance system of claim 16 wherein the gas delivery lumen of the tri-lumen tube and the gas delivery lumens of the first and second bi-lumen tubes are each provided with an inner diameter in the range of from about 4 mm to 7 mm.

18. The respiratory assistance system of claim 16 wherein the main bi-lumen tube is provided with an outer diameter of less than about 11 mm, and a length of about 2 m.

19. A respiratory assistance system, comprising:

a flow generator;

a nasal pillows mask including;

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

a piloted 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;

a fluid conduit fluidly coupling the flow generator to the nasal pillows mask, the fluid conduit being configured in manner wherein the at least one gas delivery lumen, the valve pilot lumen, and the pressure sensing lumen of the nasal pillows mask are each fluidly coupled to discrete portions of the fluid conduit, and fluid pressure introduced into the valve pilot lumen varies from that introduced into the gas delivery lumen in accordance with at least one prescribed functional parameter of the valve.

20. The respiratory assistance system of claim 19 further comprising a heat and moisture exchanger disposed within the fluid chamber of the cushion.