Method and apparatus of delivery of inhaled nitric oxide to spontaneous-breathing and mechanically-ventilated patients

A device for delivering nitric oxide to a spontaneous-breathing patient comprising:

• a source of an oxygen-containing gas connected via tubing to a patient inspiration interface device;
• a source of an nitric oxide-containing gas connected via tubing to the patient inspiration interface device;
• a first proportional flow controller located between the source of oxygen-containing gas and the patient inspiration interface device for varying the flow rate of the oxygen-containing gas to the patient inspiration interface device;
• a second proportional flow controller located between the source of nitric oxide-containing gas and the patient inspiration interface device for varying the flow rate of the nitric oxide-containing gas to the patient inspiration interface device;
• an inspiration flow profile sensor that measures the inspiration flow profile of the inspiration breath of the patient;
• and
• a controller for controlling the first and second proportional flow controllers in response to the inspiration flow profile from the inspiration flow profile sensor, the first and second proportional flow controllers being controlled such that the oxygen-containing gas has a flow profile that tracks the inspiration flow profile, and wherein the nitric oxide-containing gas has a flow profile that is proportionally less than the oxygen-containing gas throughout inspiration.

A method of delivering a non-constant concentration of nitric oxide to a mechanically-ventilated patient via single controller, the mechanical ventilator having an inspiration limb and an expiration limb, the method comprising the steps of:

• setting the desired inspiration flow profile in the controller;
• varying the flow rate of an oxygen-containing gas in accordance with the inspiration flow profile by delivering a first signal from said controller to a first control valve controlling the rate of flow of an oxygen-containing gas to the patient, thereby creating a flow profile of oxygen-containing gas;
• varying the flow rate of a nitric oxide-containing gas in accordance with the inspiration profile by delivering a second signal from said controller to a second control valve controlling the rate of flow of the nitric oxide-containing gas to the patient, creating a flow profile of nitric oxide-containing gas that is less than, but closely tracks the oxygen-containing gas flow profile in the beginning of the inspiration, wherein the difference between the flow profiles of the oxygen-containing gas and the nitric oxide-containing gas progressively increases through the remainder of inspiration;
• and
• monitoring the concentration of one or more of the following gases in the inspiration limb oxygen, nitric oxide, and nitrogen dioxide.

A device for delivering nitric oxide to a patient that is mechanically-ventilated comprising;

• a source of an oxygen-containing gas connected to a patient inspiration limb;
• a source of a nitric oxide-containing gas connected to the patient inspiration limb;
• a first proportional flow control valve located between the source of oxygen-containing gas and the patient for varying the flow rate of the oxygen-containing gas to the patient;
• a second proportional flow controller located between the source of nitric oxide-containing gas and the patient for varying the flow rate of the nitric oxide-containing gas to the patient;
• a controller including instructions for the inspiration flow profile, the controller further controlling the first and second proportional flow controllers in response to the inspiration flow profile, the first and second proportional flow controllers being controlled such that the oxygen-containing gas has a flow profile that tracks the inspiration flow profile, and wherein the nitric oxide-containing gas has a flow profile that is proportionally less than the oxygen-containing gas throughout inspiration.

A device for delivering nitric oxide to a patient that is mechanically-ventilated comprising;

• a source of an oxygen-containing gas connected to a patient inspiration limb;
• a source of a nitric oxide-containing gas connected to the patient inspiration limb;
• a first proportional flow control valve located between the source of oxygen-containing gas and the patient for varying the flow rate of the oxygen-containing gas to the patient;
• a second proportional flow controller located between the source of nitric oxide-containing gas and the patient for varying the flow rate of the nitric oxide-containing gas to the patient;
• a controller including instructions for the inspiration flow profile, the controller further controlling the first and second proportional flow controllers in response to the inspiration flow profile, the first and second proportional flow controllers being controlled such that the oxygen-containing gas has a flow profile that tracks the inspiration flow profile, and wherein the nitric oxide-containing gas flow profile is less than, but closely tracks the oxygen-containing gas flow profile in the beginning of the inspiration, wherein the difference between the flow profiles of the oxygen-containing gas and the nitric oxide-containing gas progressively increases through the remainder of inspiration.

A device for delivering nitric oxide to a patient that is mechanically-ventilated comprising;

• a source of an oxygen-containing gas connected to a patient inspiration limb;
• a source of a nitric oxide-containing gas connected to the patient inspiration limb;
• a first proportional flow control valve located between the source of oxygen-containing gas and the patient for varying the flow rate of the oxygen-containing gas to the patient;
• a second proportional flow controller located between the source of nitric oxide-containing gas and the patient for varying the flow rate of the nitric oxide-containing gas to the patient;
• a controller including instructions for the inspiration flow profile, the controller further controlling the first and second proportional flow controllers in-response to the inspiration flow profile, the first and second proportional flow controllers being controlled such that the oxygen-containing gas has a flow profile that tracks the inspiration flow profile, and wherein the nitric oxide-containing gas flow profile having a flow profile that is substantially less than the oxygen-containing gas flow profile at the beginning of inspiration, and wherein the difference between the flow profile of the oxygen-containing gas and the nitric oxide-containing gas progressively decreases throughout the remainder of inspiration.

A device for delivering nitric oxide to a spontaneous-breathing patient comprising:

• a source of an oxygen-containing gas connected via tubing to a patient inspiration interface device;
• a source of an nitric oxide-containing gas connected via tubing to the patient inspiration interface device;
• a first proportional flow controller located between the source of oxygen-containing gas and the patient inspiration interface device for varying the flow rate of the oxygen-containing gas to the patient inspiration interface device;
• a second proportional flow controller located between the source of nitric oxide-containing gas and the patient inspiration interface device for varying the flow rate of the nitric oxide-containing gas to the patient inspiration interface device;
• an inspiration flow profile sensor that measures the inspiration flow profile of the inspiration breath of the patient;
• and
• a controller for controlling the first and second proportional flow controllers in response to the inspiration flow profile from the inspiration flow profile sensor, the first and second proportional flow controllers being controlled such that the oxygen-containing gas has a flow profile that tracks the inspiration flow profile, and wherein the nitric oxide-containing gas flow profile having a flow profile that is substantially less than the oxygen-containing gas flow profile at the beginning of inspiration, and wherein the difference between the flow profile of the oxygen-containing gas and the nitric oxide-containing gas progressively decreases throughout the remainder of inspiration.

A device for delivering nitric oxide to a spontaneous-breathing patient comprising:

• a source of an oxygen-containing gas connected via tubing to a patient inspiration interface device;
• a source of an nitric oxide-containing gas connected via tubing to the patient inspiration interface device;
• a first proportional flow controller located between the source of oxygen-containing gas and the patient inspiration interface device for varying the flow rate of the oxygen-containing gas to the patient inspiration interface device;
• a second proportional flow controller located between the source of nitric oxide-containing gas and the patient inspiration interface device for varying the flow rate of the nitric oxide-containing gas to the patient inspiration interface device;
• an inspiration flow profile sensor that measures the inspiration flow profile of the inspiration breath of the patient;
• and
• a controller for controlling the first and second proportional flow controllers in response to the inspiration flow profile from the inspiration flow profile sensor, the first and second proportional flow controllers being controlled such that the oxygen-containing gas has a flow profile that tracks the inspiration flow profile, and wherein the nitric oxide-containing gas flow profile having a flow profile that is substantially less than the oxygen-containing gas flow profile at the beginning of inspiration, and wherein the difference between the flow profile of the oxygen-containing gas and the nitric oxide-containing gas progressively decreases throughout the remainder of inspiration.

A method of delivering nitric oxide via delivery means to a mechanically or spontaneously breathing patient having a certain inspiration profile comprising the steps of:

• supplying in a first breath a mixture of oxygen-containing gas and a nitric oxide-containing gas to the delivery means, the oxygen-containing gas and a nitric oxide-containing gas having a flow profile proportional or quasi proportional to the inspiration flow profile;
• supplying in at least one next breath, a source of enriched oxygen-containing gas having a flow profile that is proportional or quasi-proportional to the inspiration flow profile;
• and
• supplying a source of air at or near the end of the first and next breaths to flush the delivery means of enriched oxygen and nitric oxide.

A method of delivering a non-constant concentration of nitric oxide to a spontaneously breathing patient via delivery means comprising the steps of:

• detecting the onset of inspiration;
• determining the inspiration flow profile for an individual breath;
• supplying an oxygen-containing gas to the delivery means, the oxygen-containing gas having a flow profile that tracks the inspiration flow profile;
• supplying an nitric oxide-containing gas to the delivery means, the nitric oxide-containing gas having a flow profile that is less than, but closely tracks the oxygen-containing gas flow profile at the beginning of inspiration, wherein the difference between the flow profile of the oxygen-containing gas and the flow profile of the nitric oxide-containing gas progressively increases through the remainder of inspiration;
• and
• wherein the delivery means is an endotracheal tube.

A method of delivering a non-constant concentration of nitric oxide to a spontaneously breathing patient comprising the steps of:

• detecting the onset of inspiration;
• determining the inspiration flow profile for an individual breath;
• supplying an oxygen-containing gas to the delivery means, the oxygen-containing gas having a flow profile that tracks the inspiration flow profile;
• supplying an nitric oxide-containing gas to the delivery means, the nitric oxide-containing gas having a flow profile that is substantially less than the oxygen-containing gas flow profile at the beginning of inspiration compared to the end of inspiration, and wherein the difference between the flow profile of the oxygen-containing gas and the flow profile of the nitric oxide-containing gas progressively decreases throughout the remainder of inspiration;
• and
• wherein the delivery means is an endotracheal tube.

A method of delivering nitric oxide to a spontaneously breathing patient via delivery means comprising the steps of:

• detecting the onset of inspiration;
• supplying an oxygen-containing gas to the delivery means, the oxygen-containing gas having a pre-programmed flow profile;
• and
• supplying an nitric oxide-containing gas to the delivery means, the nitric oxide-containing gas having a pre-programmed flow profile that is proportional or quasi-proportional to the flow profile of the oxygen-containing gas throughout inspiration.

A device for delivering nitric oxide to a spontaneous-breathing patient comprising:

• a source of an oxygen-containing gas connected via tubing to a patient inspiration interface device;
• a source of an nitric oxide-containing gas connected via tubing to the patient inspiration interface device;
• a first proportional flow controller located between the source of oxygen-containing gas and the patient inspiration interface device for varying the flow rate of the oxygen-containing gas to the patient inspiration interface device;
• a second proportional flow controller located between the source of nitric oxide-containing gas and the patient inspiration interface device for varying the flow rate of the nitric oxide-containing gas to the patient inspiration interface device;
• an inspiration flow profile sensor that detects the onset of inspiration of the patient;
• and
• a controller for controlling the first and second proportional flow controllers in response to the detection of the onset of inspiration from the inspiration flow profile sensor, the first and second proportional flow controllers being controlled such that the nitric oxide-containing gas has pre-programmed flow profile that is proportional or quasi-proportional to the flow profile of the oxygen-containing gas throughout inspiration.