# US 2019/0314596 A1 · Systems and methods for generating nitric oxide

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- Number: US 2019/0314596 A1
- Document ID: US20190314596A1
- Status: Published application
- Kind: A1
- Application number: 16/388,464
- Filed: 2019-04-18
- Published: 2019-10-17
- Earliest claimed: 2017-02-27
- Assignees: Third Pole, Inc.
- Applicants: Third Pole, Inc.
- Inventors: David G. Zapol; Gregory W. Hall; Wolfgang Scholz
- Web page: https://patentgrep.com/patent/US20190314596A1

## CPC

- A61M 16/12: by mixing different gases
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61M 16/0057: {Pumps therefor}
- A61M 16/0093: {by adsorption, absorption or filtration}
- A61M 16/022: {Control means therefor}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/04: Tracheal tubes (catheters in general A61M25/00)
- 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 16/101: {using an oxygen concentrator}
- A61M 16/107: {in the inspiratory path}
- A61M 16/202: {electrically actuated}
- C01B 21/32: Apparatus
- A61M 2202/0275: Nitric oxide [NO]
- A61M 2202/0283: Nitrous oxide (N2O)
- A61M 2205/05: combined with other kinds of therapy
- A61M 2205/054: with electrotherapy
- A61M 2205/125: with incorporated filters
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/80: voice-operated command
- A61M 2205/8206: battery-operated
- A61M 2209/088: on the body
- 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)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C01B: NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; {METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C}

## Abstract

Systems and methods for nitric oxide generation are provided. In an embodiment, an NO generation system can include a controller and disposable cartridge that can provide nitric oxide to two different treatments simultaneously. The disposable cartridge has multiple purposes including preparing incoming gases for exposure to the NO generation process, scrubbing exhaust gases for unwanted materials, characterizing the patient inspiratory flow, and removing moisture from sample gases collected. Plasma generation can be done within the cartridge or within the controller. The system has the capability of calibrating NO and NO2 gas analysis sensors without the use of a calibration gas.

## Claims

### Claim at position 1

1-21. (canceled)

### Claim 22

A nitric oxide generation system, comprising:
one or more plasma chambers configured to ionize a reactant gas to generate a plasma for producing a product gas containing nitric oxide (NO) using a flow of the reactant gas through the one or more plasma chambers;
a controller configured to regulate the amount of nitric oxide in the product gas in the one or more plasma chambers using one or more parameters as input to a control algorithm, at least one of the one or more parameters being related to a target concentration of NO in a combination of the product gas and a medical gas into which the product gas flows;
a flow controller configured to provide a controlled variable flow of the reactant gas into the one or more plasma chambers based on a measurement associated with the medical gas; and
one or more scrubber paths configured to remove NO2 from the product gas generated by the one or more plasma chambers,
wherein the target concentration of NO in the combination of the product gas and the medical gas is a variable target concentration.

### Claim 23 (depends on 22)

The system of claim 22, wherein the measurement associated with the medical gas is the flow rate of the medical gas such that the flow of the reactant gas through the one or more plasma chambers is proportional to the flow rate of the medical gas.

### Claim 24 (depends on 22)

The nitric oxide generation system of claim 22, further comprising a reactant gas source that is configured to provide reactant gas flow to the one or more plasma chambers.

### Claim 25 (depends on 24)

The nitric oxide generation system of claim 24, wherein the reactant gas source is in the form of a pressurized reservoir.

### Claim 26 (depends on 24)

The nitric oxide generation system of claim 24, wherein the reactant gas source is in the form of a pump.

### Claim 27 (depends on 22)

The nitric oxide generation system of claim 22, wherein the flow controller is selected from the group consisting of one or more pumps, one or more proportional valves, one or more digital valves, and a combination of at least one proportional valve and at least one digital valve.

### Claim 28 (depends on 22)

The nitric oxide generation system of claim 22, further comprising one or more filters positioned to receive NO-enriched air from the one or more scrubber paths and configured to filter the NO-enriched air.

### Claim 29 (depends on 22)

The nitric oxide generation system of claim 22, further comprising a signal processor that generates a continuous, customizable control AC waveform as an input to a high voltage circuit.

### Claim 30 (depends on 29)

The nitric oxide generation system of claim 29, wherein the signal processor is configured to control the shape of the AC waveform by controlling at least one of its frequency and duty cycle.

### Claim 31

A nitric oxide generation system, comprising:
one or more plasma chambers configured to ionize a reactant gas to generate a plasma for producing a product gas containing nitric oxide (NO) using a flow of the reactant gas through the one or more plasma chambers;
a controller configured to regulate the amount of nitric oxide in the product gas in the one or more plasma chambers using one or more parameters as input to a control algorithm, at least one of the one or more parameters being related to at least one of a target concentration of NO in a combination of the product gas and a medical gas into which the product gas flows and a gas flow rate measurement of at least one of the medical gas and the reactant gas; and
a flow controller configured to provide a controlled variable flow of the reactant gas based on a measurement associated with a medical gas into which the product gas flows.

### Claim 32 (depends on 31)

The system of claim 31, wherein the gas flow rate measurement of the medical gas is the flow rate of the medical gas such that the air flow of the reactant gas through the one or more plasma chambers is proportional to the flow rate of the medical gas.

### Claim 33 (depends on 31)

The nitric oxide generation system of claim 31, further comprising one or more scrubber paths configured to remove NO2 from the product gas generated by the one or more plasma chambers.

### Claim 34 (depends on 31)

The nitric oxide generation system of claim 31, further comprising a reactant gas source that is configured to provide reactant gas flow to the one or more plasma chambers

### Claim 35 (depends on 34)

The nitric oxide generation system of claim 34, wherein the reactant gas source is in the form of a reservoir.

### Claim 36 (depends on 34)

The nitric oxide generation system of claim 34, wherein the reactant gas source is in the form of a pump.

### Claim 37 (depends on 34)

The nitric oxide generation system of claim 34, wherein the reactant gas source is a compressed gas source.

### Claim 38 (depends on 34)

The nitric oxide generation system of claim 34, wherein the reactant gas source is a ventilator.

### Claim 39 (depends on 31)

The nitric oxide generation system of claim 31, wherein the control algorithm input parameters are selected from the group consisting of concomitant treatment parameters, patient parameters, ambient environment parameters, device parameters, and NO treatment parameters.

### Claim 40 (depends on 39)

The nitric oxide generation system of claim 39, wherein the concomitant treatment parameters include flow, pressure, gas temperature, or gas humidity information relating to one or more devices being used in conjunction with the NO generation system.

### Claim 41 (depends on 39)

The nitric oxide generation system of claim 39, wherein the patient parameters include inspiratory flow rate, SpO2, breath timing, tidal volume, minute volume, or expiratory NO2.

### Claim 42 (depends on 39)

The nitric oxide generation system of claim 39, wherein the ambient environment parameters include ambient temperature, ambient pressure, ambient humidity, ambient NO, or ambient NO2.

### Claim 43 (depends on 39)

The nitric oxide generation system of claim 39, wherein the device parameters include plasma chamber pressure, plasma chamber flow, plasma chamber temperature, plasma chamber humidity, electrode temperature, electrode type, electrode gap, electrode age, internal enclosure humidity, or secondary circuit resonant frequency.

### Claim 44 (depends on 39)

The nitric oxide generation system of claim 39, wherein the NO treatment parameters include at least one of target NO concentration, measured NO concentration, indicated NO2 concentration, and estimated NO production.

### Claim 45 (depends on 31)

The nitric oxide generation system of claim 31, further comprising one or more scrubber paths configured to remove NO2 from the product gas generated by the one or more plasma chambers.

### Claim 46 (depends on 31)

The nitric oxide generation system of claim 31, wherein the reactant gas source is in the form of a reservoir.

### Claim 47 (depends on 31)

The nitric oxide generation system of claim 31, wherein the target concentration of NO in the combination of the product gas and the medical gas is a variable target concentration.

### Claim 48

A method for generating nitric oxide, comprising:
ionizing a reactant gas inside one or more plasma chambers to generate a plasma for producing a product gas containing nitric oxide (NO) using a flow of the reactant gas through the one or more plasma chambers;
controlling the amount of nitric oxide in the product gas in the one or more plasma chambers using one or more parameters as input to a control algorithm used by a controller to control the one or more plasma chambers, at least one of the one or more parameters being related to a target concentration of NO in a combination of the product gas and a medical gas into which the product gas flows; and
controlling the flow of the reactant gas through the one or more plasma chambers based on at least one of medical gas flow rate, target dilution of the medical gas, and the target concentration of NO in the combination of the product gas and the medical gas;
wherein the target concentration of NO in the combination of the product gas and the medical gas is a variable target concentration.
