Systems and methods for preventing and treating infections with nitric oxide

Inventors

Silkoff, Philip E. • HALL, Gregory W. • Scholz, Wolfgang

Assignees

Third Pole Inc

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Publication Number

US-11827989-B2

Patent

Publication Date

2023-11-28

Expiration Date


Abstract

System and methods for providing nitric oxide can include at least one pair of electrodes configured to generate a product gas containing nitric oxide from a flow of a reactant gas, and at least one controller configured to regulate an 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. One or more sensors are configured to collect information relating to at least one of patient information, the reactant gas, the product gas, and an inspiratory gas into which at least a portion of the product gas flows, the sensors configured to communicate the information to the controller to be used as the one or more parameters. The patient information includes information relating to a methemoglobin (MetHg) measurement collected from a MetHg sensor.

Core Innovation

The invention provides a system for providing nitric oxide by ionizing a reactant gas in at least one plasma chamber to generate a product gas containing nitric oxide. A controller regulates an amount of nitric oxide in the product gas generated in the at least one plasma chamber using one or more parameters as an input to the controller. The sensors collect information relating to at least one of patient information, the reactant gas, the product gas, and an inspiratory gas into which at least a portion of the product gas flows, and communicate the information to the controller for use as the one or more parameters.

At least one sensor is configured to collect patient information relating to a methemoglobin measurement. The system includes an injection pump in communication with the controller, and the controller controls a delivery of methylene blue from the injection pump based on the methemoglobin measurement and the amount of NO delivered to the inspiratory gas to decrease a methemoglobin level.

In some implementations reflected by dependent claims, the controller uses methemoglobin measurement information to gate, suspend, and resume nitric oxide generation based on methemoglobin reaching threshold levels, and to dynamically change a NO dose using the methemoglobin measurement so that methemoglobin stays below a threshold while maximizing the quantity of NO delivered. The system further includes regulatory concepts directed to reducing NO2 via gas handling and scrubbing and to monitoring product gas and inspiratory gas with gas analyzers and remote or inline gas measurement concepts.

Claims Coverage

The document provides two independent claim positions. Across these independent claims, the inventive features focus on plasma-chamber NO generation, controller-based NO regulation from sensor inputs including methemoglobin measurement, and controller-controlled methylene blue delivery by an injection pump based on methemoglobin and the amount of NO delivered.

Plasma chamber ionizing a reactant gas to generate NO product gas

At least one plasma chamber configured to ionize a reactant gas to generate a product gas containing nitric oxide.

Controller regulating NO amount using sensor parameters

At least one controller configured to regulate an amount of nitric oxide in the product gas generated in the at least one plasma chamber using one or more parameters as an input to the controller.

Sensors collecting methemoglobin measurement for controller inputs

One or more sensors configured to collect information relating to at least one of patient information, the reactant gas, the product gas, and an inspiratory gas into which at least a portion of the product gas flows, the sensors configured to communicate the information to the controller to be used as the one or more parameters, at least one of the one or more sensors being configured to collect patient information relating to a methemoglobin measurement.

Injection pump delivering methylene blue based on methemoglobin and NO delivered

An injection pump in communication with the controller, the controller configured to control a delivery of methylene blue from the injection pump based on the methemoglobin measurement and the amount of NO delivered to the inspiratory gas to decrease a methemoglobin level.

Sensor detecting methemoglobin measurement in patient

At least one sensor configured to detect a methemoglobin measurement in a patient to which at least a portion of the product gas is delivered.

Both independent claims share the core control architecture: a plasma chamber produces a NO-containing product gas, a controller regulates NO amount using sensor-derived parameters including methemoglobin measurement, and the controller controls an injection pump to deliver methylene blue based on the methemoglobin measurement and the amount of NO delivered to decrease methemoglobin.

Stated Advantages

Decreases a methemoglobin level in a patient using methylene blue delivery controlled based on methemoglobin measurement and the amount of NO delivered.

Keeps methemoglobin below a threshold while maximizing quantity of NO delivered (as reflected by dependent claim refinement concepts).

A defined minimum concentration requirement for NO in the product gas is explicitly stated (concentration of NO in the product gas is at least 150 ppm).

Documented Applications

Preventing or treating infections, including microbial, fungal, bacterial, viral infections (including COVID-19), using the system for providing nitric oxide.

A portable investigational device example is described as eNOX-200 with AUTO/MANUAL modes and a NO target range of 100–200 ppm.

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