Ventilation mask with integrated piloted exhalation valve
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.
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.