Method and apparatus for delivery of inhaled nitric oxide to spontaneous-breathing and mechanically-ventilated patients with intermittent dosing

• US 7,516,742 B2
• Filed: 09/23/2005
• Issued: 04/14/2009
• Est. Priority Date: 11/24/1999
• Status: Expired due to Term

• Current Assignee: Advanced Inhalation Therapies (AIT) Ltd, Vyaire Medical 207 Incorporated
• Original Assignee: Cardinal Health 200 Incorporated (Cardinal Health, Inc.), Pulmonox Technologies Corp.
• Inventors: Miller, Christopher C., McMullin, Bevin, Stenzler, Alex
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US11/234,849
• Publication Number:
  US 20060207594A1
• Time in Patent Office: 1,299 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/202.22, 128/203.12, 128/203.13, 128/203.22
• US Class Current: 128/204.23
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/1015 using a gas flush valve, e.g. oxygen flush valve
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/203 Proportional
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/102 Measuring a parameter of the content of the delivered gas
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]

Abstract

A device and method is disclosed for delivering NO to a patient. The device utilizes a single controller that controls two separate flow controllers to deliver an oxygen-containing gas and a NO-containing gas to the patient to provide NO-containing gas at a flow profile that is proportional or quasi-proportional to a flow profile of the oxygen-containing gas throughout patient inspiration. The controller further comprises logic for setting a nitric oxide delivery profile comprising at least two different concentrations of nitric oxide containing gas and for automatically switching between the at least two different concentrations of nitric oxide containing gas on a timed basis.

Claims

1. A method of delivering nitric oxide to a patient comprising the steps of:

providing a source of nitric oxide-containing gas;

providing a source of oxygen-containing gas;

detecting the onset of inspiration;

determining the inspiration flow profile for an individual breath;

administering the oxygen-containing gas with a flow profile that tracks the inspiration flow profile; and

administering the nitric oxide-containing gas with a flow profile that is proportionally less than the flow profile of the oxygen-containing gas throughout inspiration;

wherein the nitric oxide-containing gas is cyclically administered to the patient at a first concentration ranging from about 80 ppm to about 400 ppm of nitric oxide for a first period of time and at a second concentration of nitric oxide lower than the first concentration for a second period of time.

2. A method according to claim 1, wherein the method further includes the step of monitoring the concentration of at least one of the gases selected from the group consisting of:

oxygen, nitric oxide, and nitrogen dioxide.

3. A method according to claim 1, wherein the flow profile of the nitric oxide-containing gas reaches zero flow at a time near the end of the patient inspiration flow profile, and wherein when said flow reaches zero, the flow profile of the oxygen-containing gas is greater than zero.

4. A method according to claim 1, wherein the flow profile of the nitric oxide-containing gas is zero flow at the beginning of the patient inspiration flow profile, and wherein when said flow is zero, the flow profile of the oxygen-containing gas is greater than zero.

5. A method according to claim 1, wherein the flow profile of the nitric oxide-containing gas is zero at the beginning of the patient inspiration profile while the flow profile of the oxygen-containing gas is greater than zero, and wherein at a time near the end of the patient inspiration flow profile, the flow profile of the nitric oxide-containing gas is zero while the flow profile of the oxygen-containing gas is greater than zero.

6. A method according to claim 1, further comprising the step of truncating the flow profile of the nitric oxide-containing gas to zero near the end of patient inspiration.

7. A method of claim 1 wherein the second period of time is longer than the first period of time.

8. A method of claim 1 wherein the first concentration of nitric oxide ranges from about 160 ppm to about 300 ppm.

9. A method of claim 1 wherein the second concentration of nitric oxide ranges from about 20 ppm to about 40 ppm.

10. A method of claim 1 wherein the first period of time is about 30 minutes and the second period of time is about 3.5 hours.

11. A method of delivering nitric oxide to a mammal, the method comprising the step of administering to a mammal a first concentration of nitric oxide gas for a number of time periods that are interspersed with intervals wherein a second concentration of nitric oxide gas is administered during the intervals;

wherein the administration of the nitric oxide gas is at a flow profile that is less than a flow profile of an oxygen-containing gas, and the flow profile of the oxygen-containing gas being administered to the patient tracks an inspiration flow profile of the patient; and

wherein the difference between the flow profile of the oxygen-containing gas and the flow profile of the nitric oxide gas progressively increases throughout inspiration.

12. A device for delivering nitric oxide to a patient comprising:

a source of an oxygen-containing gas connected via tubing to a patient inspiration interface device;

a source of a 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; and

wherein the controller comprises logic for setting a nitric oxide delivery profile comprising at least two different concentrations of nitric oxide-containing gas and for automatically switching between the at least two different concentrations of nitric oxide-containing gas on a timed basis.

13. A device for delivering nitric oxide to a patient 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 controller 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; and

wherein the controller comprises logic for setting a nitric oxide delivery profile comprising at least two different concentrations of nitric oxide-containing gas and for automatically switching between the at least two different concentrations of nitric oxide-containing gas on a timed basis.

14. A device for delivering nitric oxide to a patient 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 controller 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; and

wherein the controller comprises logic for setting a nitric oxide delivery profile comprising at least two different concentrations of nitric oxide-containing gas and for automatically switching between the at least two different concentrations of nitric oxide-containing gas on a timed basis.

15. A device for delivering nitric oxide to a patient who 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 controller 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 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; and

wherein the controller comprises logic for setting a nitric oxide delivery profile comprising at least two different concentrations of nitric oxide-containing gas and for automatically switching between the at least two different concentrations of nitric oxide-containing gas on a timed basis.

16. 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 a 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 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; and

wherein the controller comprises logic for setting a nitric oxide delivery profile comprising at least two different concentrations of nitric oxide-containing gas and for automatically switching between the at least two different concentrations of nitric oxide-containing gas on a timed basis.

17. 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 a 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 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

wherein the controller comprises logic for setting a nitric oxide delivery profile comprising at least two different concentrations of nitric oxide-containing gas and for automatically switching between the at least two different concentrations of nitric oxide-containing gas on a timed basis.