Systems and methods for delivering nitric oxide

Inventors

Miles, ChristopherHeirtzler, FrankHALL, Gregory W.Patel, SwetaScholz, Wolfgang

Assignees

Third Pole Inc

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Publication Number

US-11975139-B2

Patent

Publication Date

2024-05-07

Expiration Date


Abstract

Systems and methods are provided for delivering one or more drugs. In some embodiments, a drug delivery system includes a housing having a distal end with an inlet through which an inspiratory flow of air passes into the housing, a proximal end having a patient interface attached thereto, the patient interface being configured to interface with a user, and an inspiratory flow pathway extending from the distal end to the proximal end of the housing. A nitric oxide (NO) source is positioned within the housing and is configured to deliver NO-containing gas to the patient interface. A secondary drug source is positioned within the housing and is configured to deliver a secondary drug to the patient interface. A controller is configured to control an amount of NO-containing gas and an amount of the secondary drug delivered using a control scheme.

Core Innovation

A drug delivery system is provided that delivers a nitric oxide (NO)-containing gas and a secondary drug to a patient through a housing and a patient interface, where an inspiratory flow of air passes into the housing and travels through an inspiratory flow pathway to the proximal patient interface. An NO source positioned within the housing delivers NO-containing gas to the patient interface, and a secondary drug source positioned within the housing delivers the secondary drug to the patient interface.

A controller controls the amount of NO-containing gas delivered and the amount of the secondary drug delivered using a control scheme informed by inputs relating to the NO-containing gas, the secondary drug, the inspiratory flow pathway, and one or more inputs from the user, with the controller communicating with one or more sensors to collect information relating to the inputs. The controller utilizes the control scheme to deliver the NO-containing gas and the secondary drug in a treatment pattern in which the controller switches between delivery of the NO-containing gas, delivery of the secondary drug, and delivery of a gas without the NO-containing gas or the secondary drug to purge the inspiratory flow pathway.

The treatment pattern is derived by the controller using information related to at least one of a potential for interaction between the NO-containing gas and the secondary drug and a time for the NO-containing gas to wear off. In an electric NO implementation, the system includes an electric nitric oxide (NO) generator positioned in the housing to generate NO-containing gas in a plasma chamber by ionizing at least a portion of the inspiratory flow of air through the plasma chamber.

Claims Coverage

The independent claims cover three related drug delivery system configurations that share a controller-driven, sensor-informed treatment pattern with switching between NO-containing gas delivery, secondary drug delivery, and purge gas delivery, where the treatment pattern is derived using at least interaction potential and NO wear-off time. Across the independent claims, the main inventive features are centered on the housing/inspiratory-flow patient interface arrangement, the NO source type, the secondary drug source, and the controller’s treatment-pattern switching and derivation criteria.

Housing with inspiratory flow pathway and patient interface

A housing having a distal end with an inlet through which an inspiratory flow of air passes into the housing, a proximal end having a patient interface attached thereto, the patient interface being configured to interface with a user, and an inspiratory flow pathway extending from the distal end of the housing to the proximal end of the housing.

Nitric oxide source and secondary drug source within the housing

A nitric oxide (NO) source positioned within the housing, the NO source configured to deliver NO-containing gas to the patient interface, and a secondary drug source positioned within the housing, the secondary drug source configured to deliver a secondary drug to the patient interface.

Controller using control scheme with sensor and user inputs

A controller configured to control an amount of NO-containing gas delivered from the NO source and an amount of the secondary drug delivered from the secondary drug source using a control scheme, the control scheme having one or more inputs relating to at least one of the NO-containing gas, the secondary drug, the inspiratory flow pathway, and one or more inputs from the user, the controller configured to communicate with one or more sensors configured to collect information relating to the one or more inputs to the control scheme.

Treatment pattern switching with purging and derivation by interaction potential and wear-off time

The controller being configured to utilize the control scheme to deliver the NO-containing gas and the secondary drug in a treatment pattern such that the controller is configured to switch between delivery of the NO-containing gas, delivery of the secondary drug, and delivery of a gas without the NO-containing gas or the secondary drug to purge the inspiratory flow pathway, wherein the treatment pattern is derived by the controller using information related to at least one of a potential for interaction between the NO-containing gas and the secondary drug and a time for the NO-containing gas to wear off.

Electric nitric oxide generator via plasma chamber ionizing inspiratory air

An electric nitric oxide (NO) generator positioned in the housing and configured to generate NO-containing gas in a plasma chamber with one or more pairs of electrodes therein by ionizing at least a portion of the inspiratory flow of air through the plasma chamber.

Across independent claims, the coverage centers on a sensor-informed controller executing a treatment pattern that switches between NO-containing gas delivery, secondary drug delivery, and purging without NO and/or secondary drug, with the pattern derived using at least interaction potential between NO and the secondary drug and a wear-off time for the NO-containing gas. One independent claim further specifies an electric NO generator that ionizes inspiratory air in a plasma chamber using pairs of electrodes.

Stated Advantages

Enables delivery of NO-containing gas and a secondary drug in a treatment pattern with switching and purging of the inspiratory flow pathway based on interaction potential between NO-containing gas and the secondary drug and a time for the NO-containing gas to wear off.

In the electric generator configuration, NO-containing gas is generated by ionizing at least a portion of the inspiratory flow of air through a plasma chamber.

Documented Applications

Infection prevention/treatment use cases.

Asthma use case.

Nasal cavity use case.

Performance/rescue/ambulance scenario use context.

Altitude sickness use case.

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