Ventilation mask with integrated piloted exhalation valve

• US 9,038,634 B2
• Filed: 08/10/2012
• Issued: 05/26/2015
• 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, Aguirre, Joey
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/572,368
• Publication Number:
  US 20120325218A1
• Time in Patent Office: 1,019 Days
• Field of Search: 128/207.13, 128/201.13, 128/205.24, 128/207.18
• 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: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• 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 16/0816 Joints or connectors
• 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 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 16/206 Capsule valves, e.g. mushroom, membrane valves
• CPC Class Codes: A61M 16/207 Membrane valves with pneumatic amplification stage, i.e. having master and slave membranes
• CPC Class Codes: A61M 2210/0618 Nose

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. The mask of the present invention 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; and

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

a tri-lumen tube which has a generally elliptical, oval-shaped cross-sectional configuration, and is fluidly coupled to the flow generator;

a first bi-lumen tube which has a generally teardrop-shaped cross-sectional configuration, and is fluidly coupled to and extends between the tri-lumen tube and the nasal pillows mask; and

a second bi-lumen tube which has a generally teardrop-shaped cross-sectional configuration, and is fluidly coupled to and extends between the tri-lumen tube and the nasal pillows mask.

2. The respiratory assistance system of claim 1 wherein:

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

the first bi-lumen tube defines 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

the second bi-lumen tube defines 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.

3. The respiratory assistance system of claim 2 further comprising:

a Y-connector which is fluidly coupled to the tri-lumen tube and each of the first and second bi-lumen tubes, the Y-connector being sized and configured to facilitate the fluid coupling of the gas delivery lumen of the tri-lumen tube to the gas delivery lumens of the first and second bi-lumen tubes, facilitate the fluid coupling of the pressure sensing lumens of the tri-lumen tube and the first bi-lumen tube to each other, and facilitate the fluid coupling of the valve pilot lumens of the tri-lumen tube and the second bi-lumen tube to each other;

the Y-connector including at least first and second members which are releasably connectable to each other as allows for the selective detachment and separation of the tri-lumen tube from each of the first and second bi-lumen tubes.

4. The respiratory assistance system of claim 3 wherein:

the Y-connector comprises male and female members;

the male member of the Y-connector is fluidly coupled to the tri-lumen tube;

the female member of the Y-connector is fluidly coupled to each of the first and second bi-lumen tubes; and

the male and female members are configured so as to be releasably attachable to each other only in a manner wherein the pressure sensing lumens of the tri-lumen tube and the first bi-lumen tube are placed into fluid communication with each other, and the valve pilot lumens of the tri-lumen tube and the second bi-lumen tube are placed into fluid communication with each other.

5. The respiratory assistance system of claim 2 wherein the gas delivery lumen of the tri-lumen tube has a generally elliptical, oval shaped cross-sectional configuration, and each of the pressure sensing and valve pilot lumens thereof has a generally circular cross-sectional configuration.

6. The respiratory assistance system of claim 2 wherein:

the gas delivery lumen of each of the first and second bi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration;

the pressure sensing and valve pilot lumens of respective ones of the first and second bi-lumen tubes each have a generally circular cross-sectional configuration; and

the pressure sensing and valve pilot lumens of the first and second bi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.

7. The respiratory assistance system of claim 6 wherein the nasal pillows mask comprises:

a first connector and a pressure port disposed in side-by-side relation to each other, the first connector having a generally circular cross-sectional configuration;

a second connector and a pilot port disposed in side-by-side relation to each other, the second connector having a generally circular cross-sectional configuration;

the relative orientations between the first connector and the pressure port, the second connector and the pilot port, the gas delivery and pressure sensing lumens of the first bi-lumen tube, and the gas delivery and pilot lumens of the second bi-lumen tube being specifically selected so as to achieve a prescribed offset between the axes of the first and second connectors and corresponding ones of the gas delivery lumens of the first and second bi-lumen tubes when the pressure and pilot ports of the mask are coaxially aligned with respective ones of the pressure sensing and pilot lumens of the first and second bi-lumen tubes, as facilitates the resilient compression of the web portion of each of the first and second bi-lumen tubes when the first and second connectors are advanced into respective ones of the gas delivery lumens of the first and second bi-lumen tubes.

8. The respiratory assistance system of claim 7 wherein:

the relative orientations of the gas delivery and pressure sensing lumens of the first bi-lumen tube are the same as those of the gas delivery and pilot lumens of the second bi-lumen tube; and

the relative orientations of the first connector and the pressure port are the same as those of the second connector and the pilot port.

9. A respiratory assistance system, comprising:

a flow generator;

a nasal pillows mask; and

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

a tri-lumen tube which defines 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 which defines a gas delivery lumen and a pressure sensing lumen which are each fluidly coupled to the nasal pillows mask; and

a second bi-lumen tube which defines a gas delivery lumen and a pilot lumen which are each fluidly coupled to the nasal pillows mask; and

a Y-connector which is fluidly coupled to the tri-lumen tube and each of the first and second bi-lumen tubes, the Y-connector being sized and configured to facilitate the fluid coupling of the gas delivery lumen of the tri-lumen tube to the gas delivery lumens of the first and second bi-lumen tubes, facilitate the fluid coupling of the pressure sensing lumens of the tri-lumen tube and the first bi-lumen tube to each other, and facilitate the fluid coupling of the valve pilot lumens of the tri-lumen tube and the second bi-lumen tube to each other;

the Y-connector including at least first and second members which are releasably connectable to each other as allows for the selective detachment and separation of the tri-lumen tube from each of the first and second bi-lumen tubes.

10. The respiratory assistance system of claim 9 wherein:

the Y-connector comprises male and female members;

the male member of the Y-connector is fluidly coupled to the tri-lumen tube;

the female member of the Y-connector is fluidly coupled to each of the first and second bi-lumen tubes; and

the male and female members are configured so as to be releasably attachable to each other only in a manner wherein the pressure sensing lumens of the tri-lumen tube and the first bi-lumen tube are placed into fluid communication with each other, and the valve pilot lumens of the tri-lumen tube and the second bi-lumen tube are placed into fluid communication with each other.

11. The respiratory assistance system of claim 9 wherein:

the gas delivery lumen of each of the first and second bi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration; and

the pressure sensing and valve pilot lumens of the first and second bi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.

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

a first connector and a pressure port disposed in side-by-side relation to each other, the first connector having a generally circular cross-sectional configuration;

a second connector and a pilot port disposed in side-by-side relation to each other, the second connector having a generally circular cross-sectional configuration;

the relative orientations between the first connector and the pressure port, the second connector and the pilot port, the gas delivery and pressure sensing lumens of the first bi-lumen tube, and the gas delivery and pilot lumens of the second bi-lumen tube being specifically selected so as to achieve a prescribed offset between the axes of the first and second connectors and corresponding ones of the gas delivery lumens of the first and second bi-lumen tubes when the pressure and pilot ports of the mask are coaxially aligned with respective ones of the pressure sensing and pilot lumens of the first and second bi-lumen tubes, as facilitates the resilient compression of the web portion of each of the first and second bi-lumen tubes when the first and second connectors are advanced into respective ones of the gas delivery lumens of the first and second bi-lumen tubes.

13. The respiratory assistance system of claim 12 wherein:

the relative orientations of the gas delivery and pressure sensing lumens of the first bi-lumen tube are the same as those of the gas delivery and pilot lumens of the second bi-lumen tube; and

the relative orientations of the first connector and the pressure port are the same as those of the second connector and the pilot port.

14. A respiratory assistance system, comprising:

a flow generator;

a nasal pillows mask; and

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

a quad-lumen tube which is fluidly coupled to the flow generator and defines a gas delivery lumen, a valve pilot lumen, a pressure sensing lumen and an auxiliary lumen;

a first bi-lumen tube which defines 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 which defines 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.

15. The respiratory assistance system of claim 14 further comprising:

a Y-connector which is fluidly coupled to the quad-lumen tube and each of the first and second bi-lumen tubes, the Y-connector being sized and configured to facilitate the fluid coupling of the gas delivery lumen of the quad-lumen tube to the gas delivery lumens of the first and second bi-lumen tubes, facilitate the fluid coupling of the pressure sensing lumens of the quad-lumen tube and the first bi-lumen tube to each other, and facilitate the fluid coupling of the valve pilot lumens of the quad-lumen tube and the second bi-lumen tube to each other.

16. The respiratory assistance system of claim 14 wherein the gas delivery lumen of the quad-lumen tube includes a central portion which has a generally cloverleaf cross-sectional configuration, and an opposed pair of end portions which each have a generally circular cross-sectional configuration.

17. The respiratory assistance system of claim 16 wherein the valve pilot, pressure sensing and auxiliary lumens of the quad-lumen tube are separated from each other by intervals of approximately 120°

, and each have a generally circular cross-sectional configuration.

18. The respiratory assistance system of claim 16 wherein the quad-lumen tube includes a reinforcement ribbon which is embedded therein and extends along at least the central portion of the gas delivery lumen thereof.

19. The respiratory assistance system of claim 14 wherein:

the gas delivery lumen of each of the first and second bi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration; and

the pressure sensing and valve pilot lumens of the first and second bi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.

20. The respiratory assistance system of claim 19 wherein the nasal pillows mask comprises:

a first connector and a pressure port disposed in side-by-side relation to each other, the first connector having a generally circular cross-sectional configuration;

a second connector and a pilot port disposed in side-by-side relation to each other, the second connector having a generally circular cross-sectional configuration;

the relative orientations between the first connector and the pressure port, the second connector and the pilot port, the gas delivery and pressure sensing lumens of the first bi-lumen tube, and the gas delivery and pilot lumens of the second bi-lumen tube being specifically selected so as to achieve a prescribed offset between the axes of the first and second connectors and corresponding ones of the gas delivery lumens of the first and second bi-lumen tubes when the pressure and pilot ports of the mask are coaxially aligned with respective ones of the pressure sensing and pilot lumens of the first and second bi-lumen tubes, as facilitates the resilient compression of the web portion of each of the first and second bi-lumen tubes when the first and second connectors are advanced into respective ones of the gas delivery lumens of the first and second bi-lumen tubes.