# US 10,946,163 B2 · Systems and methods for generating nitric oxide

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- Number: US 10,946,163 B2
- Document ID: US10946163B2
- Status: Granted
- Kind: B2
- Application number: 16/909,722
- Filed: 2020-06-23
- Published: 2020-12-17
- Granted: 2021-03-16
- Earliest claimed: 2017-02-27
- Assignees: Third Pole, Inc.
- Applicants: Third Pole, Inc.
- Inventors: Ian J. Gillerman; Gregory W. Hall; Wolfgang Scholz; David G. Zapol
- Web page: https://patentgrep.com/patent/US10946163B2

## 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 1

A nitric oxide (NO) generation system, comprising:
at least one pair of electrodes configured to generate a product gas containing nitric oxide from a flow of a reactant gas;
at least one controller configured to regulate the amount of nitric oxide in the product gas generated by the at least one pair of electrodes using one or more parameters as an input to the controller, the one or more parameters including information from a plurality of sensors configured to collect information relating to at least one of the reactant gas, the product gas, and an inspiratory gas into which at least a portion of the product gas flows; and
wherein a first portion of the product gas is injected into an inspiratory gas and a second portion of the product gas is recirculated to the NO generation system to form a recirculation loop of the product gas.

### Claim 2 (depends on 1)

The NO generation system of claim 1, wherein a flow rate of the product gas from the NO generation system is higher than a flow rate of the first portion of the product gas injected into the inspiratory gas to reduce transit time and NO2 formation in the injected product gas.

### Claim 3 (depends on 1)

The NO generation system of claim 1, further comprising a recirculation pump for pumping a mixture of the product gas and recirculated product gas through the recirculation loop.

### Claim 4 (depends on 3)

The NO generation system of claim 3, further comprising a scrubber configured to continuously remove NO2 from the mixture of product gas and recirculated product gas as the recirculation pump pumps the gas mixture through the recirculation loop.

### Claim 5 (depends on 1)

The NO generation system of claim 1, wherein the second portion of the product gas is recirculated to the at least one pair of electrodes.

### Claim 6 (depends on 1)

The NO generation system of claim 1, further comprising a scrubber for removing NO2 is positioned downstream of the at least one pair of electrodes.

### Claim 7 (depends on 1)

The NO generation system of claim 1, further comprising a valve for controlling the injection of the first portion of the product gas into the inspiratory gas.

### Claim 8 (depends on 1)

The NO generation system of claim 1, further comprising a valve configured to direct the first portion of the product gas to the inspiratory gas by closing on a return leg of the recirculation of the second portion of the product gas.

### Claim 9 (depends on 1)

The NO generation system of claim 1, wherein the recirculation loop is in a nasal cannula.

### Claim 10 (depends on 1)

The NO generation system of claim 1, wherein the concentration of NO in the product gas is between 5 ppm and 5000 ppm.

### Claim 11 (depends on 1)

The NO generation system of claim 1, wherein a flow of the first portion of the product gas is timed with an inspiratory event.

### Claim 12

A nitric oxide (NO) generation system, comprising:
at least one pair of electrodes configured to generate a product gas containing nitric oxide from a flow of a reactant gas;
at least one controller configured to regulate the amount of nitric oxide in the product gas by the at least one pair of electrodes using one or more parameters as an input to the controller, the one or more parameters including information from a plurality of sensors configured to collect information relating to at least one of the reactant gas, the product gas, and an inspiratory gas into which at least a portion of the product gas flows;
a valve configured to direct a first portion of the product gas to an inspiratory gas and a second portion of the product gas to a recirculation path back to the NO generation system; and
a scrubber configured to continuously remove NO2 from a combination of product gas from the at least one pair of electrodes and the second portion of the product gas.

### Claim 13 (depends on 12)

The NO generation system of claim 12, wherein the second portion of the product gas is recirculated to the at least one pair of electrodes.

### Claim 14 (depends on 12)

The NO generation system of claim 12, wherein the concentration of NO in the product gas is between 5 ppm and 5000 ppm.

### Claim 15 (depends on 12)

The NO generation system of claim 12, wherein the recirculation loop is in a nasal cannula.

### Claim 16

A method of generating nitric oxide (NO) comprising:
ionizing a reactant gas using at least one pair of electrodes to generate a plasma for producing a product gas containing nitric oxide within a flow comprising a reactant gas;
controlling the amount of nitric oxide in the product gas using one or more parameters as input to a control algorithm used by one or more controllers to control the electrodes, at least one of the one or more parameters being related to information from a plurality of sensors configured to collect information relating to at least one of the reactant gas, the product gas, and an inspiratory gas into which at least a portion of the product gas flows;
injecting a first portion of the product gas into an inspiratory gas; and
recirculating a second portion of the product gas into the NO generation system to form a recirculation loop therein.

### Claim 17 (depends on 16)

The method of claim 16, wherein NO2 formation in the first portion of the product gas is reduced by utilizing a recirculation loop flow rate that is greater than or equal to an injected flow rate.

### Claim 18 (depends on 16)

The method of claim 16, wherein the second portion of the product gas is recirculated continuously.

### Claim 19 (depends on 16)

The method of claim 16, wherein the flow rate through the recirculation loop is constant.

### Claim 20 (depends on 16)

The method of claim 16, wherein the flow of reactant gas is a continuous variable flow.
