# US 9,038,635 B2 · Ventilation mask with integrated piloted exhalation valve > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,038,635 B2 - Document ID: US9038635B2 - Status: Granted - Kind: B2 - Application number: 13/798,931 - Filed: 2013-03-13 - Published: 2013-07-25 - Granted: 2015-05-26 - Earliest claimed: 2011-06-22 - Assignees: Breathe Technologies, Inc. - Applicants: Breathe Technologies, Inc. - Inventors: Enrico Brambilla - Web page: https://patentgrep.com/patent/US9038635B2 ## CPC - 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)} - A61B 5/03: Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure {; Measuring pressure in body tissues or organs (determining bladder or urethral pressure A61B5/205)} - A61B 5/087: Measuring breath flow - A61B 5/097: Devices for facilitating collection of breath or for directing breath into or through measuring devices - A61M 16/0066: {Blowers or centrifugal pumps} - A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation} - A61M 16/0816: {Joints or connectors} - A61M 16/0833: {T- or Y-type connectors, e.g. Y-piece} - A61M 16/0858: {Pressure sampling ports} - A61M 16/0875: {Connecting tubes} - A61M 16/1045: {Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas} - A61M 16/20: Valves specially adapted to medical respiratory devices - A61M 16/201: {Controlled valves} - A61M 16/206: {Capsule valves, e.g. mushroom, membrane valves} - A61M 16/207: {Membrane valves with pneumatic amplification stage, i.e. having leader and follower membranes} - A61M 2210/0618: Nose - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract The disclosure is directed to various tubing arrangements and an associated Y-connector which may be used to facilitate the operative interface of the mask to a ventilator within a ventilation system. The tubing arrangement may comprise a pair of bi-lumen tubes. One end of each of the bi-lumen tubes is fluidly connected to the mask, with the opposite end being fluidly connected to the Y-connector. The Y-connector is in turn fluidly connected to one end of either a tri-lumen tube or a quad-lumen tube also included in the tubing arrangement, the opposite end of such tri-lumen tube or quad-lumen tube being fluidly connected to the ventilator. The Y-connector is uniquely configured to fluidly connect certain lumens of the tri-lumen tube or the quad-lumen tube to dedicated, corresponding ones of the lumens included in respective ones of the bi-lumen tubes, and to further allow for the selective detachment of the tri-lumen tube or the quad-lumen tube from the bi-lumen tubes. ## Claims ### Claim 1 A respiratory assistance system, comprising: a flow generator; a ventilation mask; and a fluid conduit fluidly coupling the flow generator to the ventilation mask, and comprising: a multi-lumen tube which 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 multi-lumen tube and the ventilation 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 multi-lumen tube and the ventilation mask. ### Claim 2 (depends on 1) The respiratory assistance system of claim 1 wherein: the multi-lumen tube defines at least 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 multi-lumen tube and the ventilation mask, and a pressure sensing lumen which is fluidly coupled to and extends between the pressure sensing lumen of the multi-lumen tube and the ventilation 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 multi-lumen tube and the ventilation mask, and a valve pilot lumen which is fluidly coupled to and extends between the valve pilot lumen of the multi-lumen tube and the ventilation mask. ### Claim 3 (depends on 2) The respiratory assistance system of claim 2 wherein the multi-lumen tube is a quad-lumen tube which has a generally circular cross-sectional configuration and further defines an auxiliary lumen. ### Claim 4 (depends on 3) The respiratory assistance system of claim 3 wherein the valve pilot, pressure sensing and auxiliary lumens of the quad-lumen tube are arranged about the gas delivery lumen thereof in equidistantly spaced intervals of about 120°. ### Claim 5 (depends on 4) The respiratory assistance system of claim 4 wherein the gas delivery lumen of the quad-lumen tube has a generally cloverleaf shaped cross-sectional configuration, and each of the pressure sensing, valve pilot and auxiliary lumens thereof has a generally circular cross-sectional configuration. ### Claim 6 (depends on 2) The respiratory assistance system of claim 2 further comprising: a Y-connector which is fluidly coupled to the multi-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 multi-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 multi-lumen tube and the first bi-lumen tube to each other, and facilitate the fluid coupling of the valve pilot lumens of the multi-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 multi-lumen tube from each of the first and second bi-lumen tubes. ### Claim 7 (depends on 6) The respiratory assistance system of claim 6 wherein: the Y-connector comprises male and female members; the male member of the Y-connector is coupled to the multi-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 gas delivery lumens of the multi-lumen tube and the first and second bi-lumen tubes are placed into fluid communication with each other, the pressure sensing lumens of the multi-lumen tube and the first bi-lumen tube are placed into fluid communication with each other, and the valve pilot lumens of the multi-lumen tube and the second bi-lumen tube are placed into fluid communication with each other. ### Claim 8 (depends on 2) 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. ### Claim 9 (depends on 8) The respiratory assistance system of claim 8 wherein the ventilation 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. ### Claim 10 (depends on 9) The respiratory assistance system of claim 9 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. ### Claim 11 A respiratory assistance system, comprising: a flow generator; a ventilation mask; and a fluid conduit fluidly coupling the flow generator to the ventilation mask, and comprising: a multi-lumen tube which defines at least 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 ventilation mask; and a second bi-lumen tube which defines a gas delivery lumen and a pilot lumen which are each fluidly coupled to the ventilation mask; and a Y-connector which is fluidly coupled to the multi-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 multi-lumen tube to the gas delivery lumens of the first and second bi-lumen tubes, the fluid coupling of the pressure sensing lumens of the multi-lumen tube and the first bi-lumen tube to each other, and the fluid coupling of the valve pilot lumens of the multi-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 multi-lumen tube from each of the first and second bi-lumen tubes. ### Claim 12 (depends on 11) The respiratory assistance system of claim 11 wherein: the Y-connector comprises male and female members; the male member of the Y-connector is coupled to the multi-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 gas delivery lumens of the multi-lumen tube and the first and second bi-lumen tubes are placed into fluid communication with each other, the pressure sensing lumens of the multi-lumen tube and the first bi-lumen tube are placed into fluid communication with each other, and the valve pilot lumens of the multi-lumen tube and the second bi-lumen tube are placed into fluid communication with each other. ### Claim 13 (depends on 11) The respiratory assistance system of claim 11 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. ### Claim 14 (depends on 13) The respiratory assistance system of claim 13 wherein the ventilation 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. ### Claim 15 (depends on 14) The respiratory assistance system of claim 14 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. ### Claim 16 A respiratory assistance system, comprising: a flow generator; a ventilation mask; and a fluid conduit fluidly coupling the flow generator to the ventilation 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 multi-lumen tube which defines at least a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the quad-lumen tube and the ventilation mask, and a pressure sensing lumen which is fluidly coupled to and extends between the pressure sensing lumen of the quad-lumen tube and the ventilation mask; and a second multi-lumen tube which defines at least a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the quad-lumen tube and the ventilation mask, and a valve pilot lumen which is fluidly coupled to and extends between the valve pilot lumen of the quad-lumen tube and the ventilation mask. ### Claim 17 (depends on 16) The respiratory assistance system of claim 16 further comprising: a Y-connector which is fluidly coupled to the quad-lumen tube and each of the first and second multi-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 multi-lumen tubes, the fluid coupling of the pressure sensing lumens of the quad-lumen tube and the first multi-lumen tube to each other, and the fluid coupling of the valve pilot lumens of the quad-lumen tube and the second multi-lumen tube to each other. ### Claim 18 (depends on 16) 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. ### Claim 19 (depends on 16) 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 a portion thereof. ### Claim 20 (depends on 16) The respiratory assistance system of claim 16 wherein: the gas delivery lumen of each of the first and second multi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration; and the pressure sensing and valve pilot lumens of the first and second multi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.