# US 10,307,553 B2 · Non-invasive breathing assistance apparatus and method

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- Number: US 10,307,553 B2
- Document ID: US10307553B2
- Status: Granted
- Kind: B2
- Application number: 14/085,708
- Filed: 2013-11-20
- Published: 2014-03-20
- Granted: 2019-06-04
- Earliest claimed: 2010-10-05
- Assignees: CareFusion 207, Inc.
- Applicants: CareFusion 207, Inc.
- Inventors: Christopher M. Varga; Geoffrey C. Wise
- Web page: https://patentgrep.com/patent/US10307553B2

## 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)}
- A61M 16/00: Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators (iron lungs A61H31/02); Tracheal tubes
- A61M 16/0672: {Nasal cannula assemblies for oxygen therapy}
- A61M 16/0858: {Pressure sampling ports}
- A61M 16/127: {by Venturi effect, i.e. entrainment mixers}
- A61M 2240/00: Specially adapted for neonatal use
- 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)}

## Abstract

An nCPAP device for assisting patient breathing includes a generator body forming an inlet, a chamber, and first and second flow circuits. The chamber directs pressurized gas from the inlet to the flow circuits. The flow circuits each include a nozzle, a channel, and at least one port. The nozzle emits a jet stream into the channel in a direction of a patient side thereof. The port fluidly connects the channel to ambient, and promotes entrainment of ambient air with the jet stream. In some embodiments, the channel forms a ramp feature directing exhaled air toward the jet stream in an angular fashion. The generator body requires reduced driving pressures to achieve target CPAP levels and reduces total imposed WOB as compared to conventional designs.

## Claims

### Claim 1

A method for establishing and delivering a continuous positive airway pressure to a patient, the method comprising:
fluidly connecting a generator body to nares of a patient, the generator body forming first and second flow circuits each including a nozzle, a channel forming first and second ramp regions, and an open port, the open port fluidly connecting the corresponding channel with ambient at a port location between an outlet end of the corresponding nozzle and a patient side of the corresponding channel, the open port angularly aligned above the first ramp region, wherein the first ramp region is a first sloped surface that extends from a location opposite the open port to a transition location that is not opposite the open port, and wherein the second ramp region is a second sloped surface that extends from the transition location toward the patient side;
forcing gas from a source of pressurized gas at a driving pressure to an inlet end of each of the nozzles;
directing a jet stream from each the nozzles toward the patient's nares via the corresponding channel to establish a continuous positive airway pressure in the patient's airway;
during periods of patient inhalation, the jet stream delivering gas flow to the patient and establishing recirculating flow along the second ramp region, wherein the transition location is located downstream from the first ramp region and upstream from the second ramp region with respect to the gas flow during the periods of patient inhalation; and
during periods of patient exhalation, exhaled air from the patient being directed by the second ramp region to divert the jet stream to the corresponding open port.

### Claim 2 (depends on 1)

The method of claim 1, wherein the driving pressure is not greater than 110 cm H2O and the established continuous positive airway pressure level is 20 cm H2O.

### Claim 3 (depends on 2)

The method of claim 2, wherein the driving pressure is not greater than 60 cm H2O.

### Claim 4 (depends on 1)

The method of claim 1, wherein the driving pressure is not greater than 25 cm H2O, the established continuous positive airway pressure is 5 cm H2O, and a total imposed work-of-breathing for a 9 mL tidal volume patient during the periods of inhalation and exhalation is not greater than 140 mJ/L.

### Claim 5 (depends on 4)

The method of claim 4, wherein the driving pressure is not greater than 18 cm H2O.

### Claim 6 (depends on 4)

The method of claim 4, wherein the total imposed work-of-breathing is not greater than 80 mJ/L.

### Claim 7 (depends on 1)

The method of claim 1, wherein the driving pressure is not greater than 25 cm H2O, the established continuous positive airway pressure is 5 cm H2O, and a total imposed work-of-breathing for a 24 mL tidal volume patient during the periods of inhalation and exhalation is not greater than 200 mJ/L.

### Claim 8 (depends on 7)

The method of claim 7, wherein the driving pressure is not greater than 18 cm H2O.

### Claim 9 (depends on 7)

The method of claim 7, wherein the total imposed work-of-breathing is not greater than 130 mJ/L.

### Claim 10 (depends on 1)

The method of claim 1, wherein the source of pressurized gas is a ventilator.

### Claim 11 (depends on 1)

The method of claim 1, wherein in longitudinal cross-section, the channel of each of the flow circuits is defined by a lower wall surface opposite an upper wall surface, the corresponding open port being formed in the upper wall surface, and further wherein the ramp regions are defined along the lower wall surface including the first sloped surface of the first ramp region and the second sloped surface of the second ramp region, and further wherein the lower wall surface is non-parallel with the upper wall surface along at least the second sloped surface of the second ramp region.

### Claim 12 (depends on 11)

The method of claim 11, wherein the lower wall surface projects toward the upper wall surface in extension to the transition location along the first ramp region, and the lower wall surface projects away from the upper wall surface in extension from the transition location toward the patient side along the second ramp region.

### Claim 13

A method for establishing and delivering a continuous positive airway pressure to a patient, the method comprising:
fluidly connecting first and second flow circuits of a generator body to naris, respectively, of a patient,
forcing gas from a source of pressurized gas at a driving pressure of not greater than 25 cm H2O to an inlet side of the generator body;
converting the gas to a jet stream within a channel of each of the circuits to establish a continuous positive airway pressure in the patient's airway of 5 cm H2O; and
providing entrainment of ambient air and/or exhaust of exhaled air through an open port angularly aligned above the channel such that, during periods of patient inhalation and exhalation, a total imposed work-of-breathing for a 9 mL tidal volume patient is not greater than 140 mL/J,
wherein each channel comprises first and second ramp regions in a lower wall surface that is opposite an upper wall surface, wherein the open port of each flow circuit comprises an opening in the upper wall surface that fluidly connects the corresponding channel with ambient at a port location between an outlet end of a corresponding nozzle and a patient side of the corresponding channel, wherein the open port of each flow circuit is angularly aligned above the first ramp region of the corresponding channel, wherein the first ramp region is a sloped surface that extends from a location opposite the opening in the upper wall surface to a transition location opposite a portion of the upper wall surface away from the open port, wherein the second ramp region extends from the transition location toward the patient side, and wherein the transition location is located downstream from the first ramp region and upstream from the second ramp region with respect to gas flow during periods of patient inhalation.

### Claim 14 (depends on 13)

The method of claim 13, wherein the total imposed work-of-breathing for a 24 mL patient is not greater than 200 mJ/L.

### Claim 15 (depends on 13)

The method of claim 13, wherein each open port comprises a primary open port formed through a thickness of the generator body and defined by a leading end wall and a trailing end wall, wherein the leading end wall is proximate a nozzle, projects radially outwardly in extension from the corresponding channel to an exterior aperture, and tapers inwardly from the exterior aperture.

### Claim 16 (depends on 15)

The method of claim 15, wherein each open port further comprises a secondary open port that extends from the corresponding channel at a secondary port location generally opposite that of the primary port.
