# US 8,333,194 B2 · High flow therapy device utilizing a non-sealing respiratory interface and related methods

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- Number: US 8,333,194 B2
- Document ID: US8333194B2
- Status: Granted
- Kind: B2
- Application number: 11/638,981
- Filed: 2006-12-14
- Published: 2007-08-02
- Granted: 2012-12-18
- Earliest claimed: 2005-09-12
- Assignees: Mergenet Medical, Inc.
- Inventors: Charles A. Lewis; Robert M. Landis
- Web page: https://patentgrep.com/patent/US8333194B2

## CPC

- A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation}
- A61J 11/0005: {having additional ports, e.g. for connecting syringes or straws (devices for administering medicines orally A61J7/00)}
- A61M 16/0051: {with alarm devices}
- A61M 16/0057: {Pumps therefor}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/0493: {with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block}
- 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 16/0677: {Gas-saving devices therefor}
- A61M 16/085: {Gas sampling}
- A61M 16/0858: {Pressure sampling ports}
- A61M 16/107: {in the inspiratory path}
- A61M 16/1075: {by influencing the temperature (A61M16/1045 takes precedence)}
- A61M 16/109: {the humidifying liquid or the beneficial agent}
- A61M 16/1095: {in the connecting tubes}
- A61M 16/12: by mixing different gases
- A61M 16/125: {Diluting primary gas with ambient air}
- A61M 16/142: {with semi-permeable walls separating the liquid from the respiratory gas}
- A61M 16/16: Devices to humidify the respiration air {(A61M16/1045 takes precedence)}
- A61M 16/20: Valves specially adapted to medical respiratory devices
- A61M 16/203: {Proportional}
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 16/18: Vaporising devices for anaesthetic preparations
- A61M 2016/0024: {with an on-off output signal, e.g. from a switch}
- A61M 2016/0027: {pressure meter}
- A61M 2016/1025: {the O2 concentration}
- A61M 2016/103: {the CO2 concentration}
- A61M 2202/0208: Oxygen
- A61M 2205/18: with alarm
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/3653: by Joule effect, i.e. electric resistance
- A61M 2205/50: with microprocessors or computers
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/42: Rate
- A61M 2230/432: partial CO2 pressure (P-CO2)
- A61M 2230/435: partial O2 pressure (P-O2)
- A61M 2230/50: Temperature
- 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)}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

A high flow therapy system including a microprocessor, a heating element a non-sealing respiratory interface and a sensor is disclosed. The heating element is disposed in electrical communication with the microprocessor and is capable of heating a liquid to create a gas. The non-sealing respiratory interface is configured to deliver the gas to a patient. The sensor is disposed in electrical communication with the microprocessor and is configured to measure pressure in an upper airway of the patient.

## Claims

### Claim 1

A high flow therapy system for delivering pressurized, heated and humidified respiratory gas to an airway of a patient, the system comprising:
a respiratory gas flow pathway for delivering the pressurized respiratory gas to the airway of the patient by way of a non-sealing respiratory interface; wherein flow rate of the pressurized respiratory gas is controlled by a microprocessor; a mixing area for mixing oxygen and air in the respiratory gas flow pathway; a humidification area for humidifying respiratory gas in the respiratory gas flow pathway; a heated delivery conduit for minimizing condensation of humidified respiratory gas; a pressure pathway
for monitoring pressure of the airway of the patient and communicating the monitored pressure to the microprocessor; and,
a sensor disposed in communication with the pressure pathway, the sensor further disposed in communication with the microprocessor and configured to measure pressure in the airway of the patient,
wherein the system is configured for controlling the flow rate of the respiratory gas delivered to the patient based on the monitored pressure of the airway of the patient during use.

### Claim 2 (depends on 1)

The high flow therapy system of claim 1, wherein the non-sealing respiratory interface includes a nasal cannula.

### Claim 3 (depends on 1)

The high flow therapy system of claim 1, wherein the sensor is disposed at least partially within the upper airway of the patient.

### Claim 4 (depends on 1)

The high flow therapy system of claim 1, wherein the sensor is disposed adjacent the oral cavity of a patient.

### Claim 5 (depends on 1)

The high flow therapy system of claim 1, further including a fluid conduit extending to the airway of the patient.

### Claim 6 (depends on 5)

The high flow therapy system of claim 5, further including a gas analyzer disposed in communication with the microprocessor.

### Claim 7 (depends on 5)

The high flow therapy system of claim 5, further including a pump disposed in mechanical cooperation with a portion of the conduit and being configured to pump air from the airway of the patient to the high flow therapy system.

### Claim 8 (depends on 5)

The high flow therapy system of claim 5, further including a pump disposed in mechanical cooperation with a portion of the conduit and being configured to pump fluid from the high flow therapy system towards the patient.

### Claim 9 (depends on 5)

The high flow therapy system of claim 5, further including a valve in mechanical cooperation with the fluid conduit, the fluid conduit being configured to allow gas to travel towards the patient.

### Claim 10 (depends on 1)

The high flow therapy system of claim 1, further including a conduit extending between the oral cavity of the patient and the sensor.

### Claim 11 (depends on 1)

The high flow therapy system of claim 1, wherein at least one of respiration rate, tidal volume and minute volume are calculated by the microprocessor using data from the airway pressure sensor.

### Claim 12 (depends on 1)

The high flow therapy system of claim 1, wherein the microprocessor is configured to control at least one of the temperature of the gas, the humidity of the gas, the amount of oxygen in the gas, the flow rate of the gas and the volume of the gas delivered to the patient.

### Claim 13 (depends on 1)

The high flow therapy system of claim 1, further comprising a blower disposed in mechanical cooperation with the non-sealing respiratory interface and capable of advancing the gas at least partially through the non-sealing respiratory interface.

### Claim 14 (depends on 13)

The high flow therapy system of claim 13, wherein the blower is configured for providing a patient with gas flow rates of up to 60 liters per minute.

### Claim 15 (depends on 13)

The high flow therapy system of claim 13, further including an oxygen inlet configured to connect to an external source of oxygen.

### Claim 16 (depends on 1)

The high flow therapy system of claim 1, wherein the sensor is configured to measure inspiration pressure and expiration pressure of the patient.

### Claim 17 (depends on 1)

The high flow therapy system of claim 1, wherein the microprocessor is configured to adjust flow rates based on at least one of a pre-programmed algorithm and a setting inputted by an operator.

### Claim 18 (depends on 1)

The high flow therapy system of claim 1, further including an oxygen inlet configured to connect to an external source of oxygen.

### Claim 19 (depends on 1)

The high flow therapy system of claim 1, further including a gas analyzer disposed in communication with the microprocessor.

### Claim 20 (depends on 1)

The high flow therapy system of claim 1, further including an alarm in communication with the microprocessor for signaling when patient airway conditions deviate from pre-determined criteria.

### Claim 21 (depends on 20)

The high flow therapy system of claim 20, wherein the alarm provides at least one of visual and auditory feedback.

### Claim 22 (depends on 1)

The high flow therapy system of claim 1, wherein the pressure pathway is at least partially enclosed within the gas flow pathway.

### Claim 23 (depends on 1)

The high flow therapy system of claim 1, wherein the pressure pathway and the gas flow pathway are provided by a dual lumen conduit.

### Claim 24

A high flow therapy device for delivering pressurized, heated and humidified respiratory gas to an airway of a patient, the high flow therapy device, comprising:
a microprocessor configured to control a flow rate of the pressurized respiratory gas;
a respiratory gas flow pathway; a mixing area for mixing oxygen and air in the respiratory gas flow pathway; a humidification area for humidifying respiratory gas in the respiratory gas flow pathway; a heated delivery conduit for minimizing condensation of humidified respiratory gas; a first interface
configured to deliver the gas to a patient; and
a sensor disposed in communication with the microprocessor and configured to measure pressure in an airway of the patient; and
a second interface configured to facilitate measuring pressure of the airway of the patient disposed in mechanical communication with the sensor.

### Claim 25 (depends on 24)

The high flow therapy device of claim 24, further including at least one conduit extending between a portion of the second interface and the sensor.

### Claim 26 (depends on 24)

The high flow therapy device of claim 24, wherein the second interface includes a mouthpiece.

### Claim 27

A high flow therapy system for delivering pressurized, heated and humidified respiratory gas to an airway of a patient, the system comprising:
a respiratory gas flow pathway for delivering the pressurized respiratory gas to the airway of the patient by way of a non-sealing respiratory interface; wherein flow rate of the pressurized respiratory gas is controlled by a microprocessor; a mixing area for mixing oxygen and air in the respiratory gas flow pathway; a humidification area for humidifying respiratory gas in the respiratory gas flow pathway; a heated delivery conduit for minimizing condensation of humidified respiratory gas; and,
a pressure pathway for monitoring pressure of the airway of the patient and communicating the monitored pressure to the microprocessor;
wherein the system is configured to provide for adjustment of the flow rate of the respiratory gas so that the flow rate of the respiratory gas is one of equals and exceeds the inspiratory flow rate of the patient during use.

### Claim 28 (depends on 27)

The high flow therapy system of claim 27, wherein the non-sealing respiratory interface includes a nasal cannula.

### Claim 29 (depends on 27)

The high flow therapy system of claim 27, wherein the system is configured for controlling the flow rate of the respiratory gas delivered to the patient based on the monitored pressure of the airway of the patient during use.

### Claim 30 (depends on 27)

The high flow therapy system of claim 27, further including an alarm in communication with the microprocessor for signaling when patient airway conditions deviate from pre-determined criteria.

### Claim 31 (depends on 27)

The high flow therapy system of claim 27, further including a sensor disposed in communication with the pressure pathway, the sensor further disposed in communication with the microprocessor and configured to measure pressure in the airway of the patient.

### Claim 32 (depends on 31)

The high flow therapy system of claim 31, wherein at least one of respiration rate, tidal volume and minute volume are calculated by the microprocessor using data from the airway pressure sensor.

### Claim 33 (depends on 31)

The high flow therapy system of claim 31, wherein the sensor is configured to measure inspiration pressure and expiration pressure of the patient.

### Claim 34 (depends on 27)

The high flow therapy system of claim 27, wherein the system is configured for providing a patient with gas flow rates of up to 60 liters per minute.

### Claim 35

A high flow therapy system for delivering pressurized, heated and humidified respiratory gas to an airway of a patient, the system comprising:
a respiratory gas flow pathway for delivering the pressurized respiratory gas to the airway of the patient by way of a non-sealing respiratory interface; wherein flow rate of the pressurized respiratory gas is controlled by a microprocessor; a mixing area for mixing oxygen and air in the respiratory gas flow pathway; a humidification area for humidifying respiratory gas in the respiratory gas flow pathway; a heated delivery conduit for minimizing condensation of humidified respiratory gas; and,
a pressure pathway for monitoring pressure of the airway of the patient and communicating the monitored pressure to the microprocessor;
wherein the system is configured to provide for adjustment of the flow rate of the respiratory gas so that the monitored inspiratory pressure of the airway of the patient during use is one of equals and exceeds the ambient air pressure.

### Claim 36 (depends on 35)

The high flow therapy system of claim 35, wherein at least one of respiration rate, tidal volume and minute volume are calculated by the microprocessor using data from the monitored airway pressure.

### Claim 37

A high flow therapy system for delivering pressurized, heated and humidified respiratory gas to an airway of a patient, the system comprising:
a respiratory gas flow pathway for delivering the pressurized respiratory gas to the airway of the patient by way of a non-sealing respiratory interface; wherein flow rate of the pressurized respiratory gas is controlled by a microprocessor; a mixing area for mixing oxygen and air in the respiratory gas flow pathway; a humidification area for humidifying respiratory gas in the respiratory gas flow pathway; a heated delivery conduit for minimizing condensation of humidified respiratory gas; and,
a pressure pathway for monitoring pressure of the airway of the patient and communicating the monitored pressure to the microprocessor;
wherein the system is configured to provide for adjustment of the flow rate of the respiratory gas so that entrainment of ambient air by the patient during use is one of minimized and eliminated.

### Claim 38 (depends on 37)

The high flow therapy system of claim 37, wherein the system is configured for controlling the flow rate of the respiratory gas delivered to the patient based on the monitored pressure of the airway of the patient during use.

### Claim 39 (depends on 37)

The high flow therapy system of claim 37, wherein at least one of respiration rate, tidal volume and minute volume are calculated by the microprocessor using data from the monitored airway pressure.

### Claim 40 (depends on 37)

The high flow therapy system of claim 37, further including an alarm in communication with the microprocessor for signaling when patient airway conditions deviate from pre-determined criteria.

### Claim 41 (depends on 37)

The high flow therapy system of claim 37, wherein the system is configured for providing a patient with gas flow rates of up to 60 liters per minute.
