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

• US 6,581,599 B1
• Filed: 11/24/1999
• Issued: 06/24/2003
• Est. Priority Date: 11/24/1999
• Status: Expired due to Term

• Current Assignee: Advanced Inhalation Therapies (AIT) Ltd
• Original Assignee: Sensormedics Corporation (Becton, Dickinson & Co)
• Inventors: Stenzler, Alex
• Primary Examiner(s): Ruhl, Dennis
• Assistant Examiner(s): PATEL, MITAL B
• Application Number:
  US09/449,240
• Time in Patent Office: 1,308 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 2016/102 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. The flow profiles of the oxygen-containing gas and the NO-containing gas are controlled by the controller. In one aspect of the invention, the flow profile of the NO-containing gas is proportional to the flow profile of the oxygen-containing gas throughout patient inspiration. In this regard, the patient receives a steady concentration of NO. In another aspect of the invention, the flow profile of the NO-containing gas is quasi-proportional to the flow profile of the oxygen-containing gas. In this regard, the NO-containing gas flow profile is altered to provide an increased concentration of NO either at the beginning or end of inspiration. In one aspect, the delivery device is used with mechanically-ventilated patients. In the other aspect of the delivery device, the device is used with spontaneously-breathing patients. The device and method, in a preferred embodiment, further contemplates using a gas purge or air flush feature to remove enriched-oxygen and/or NO from the device.

Claims

1. 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 an inspiration flow profile for an individual breath;

supplying an oxygen-containing gas to the delivery means, the oxygen-containing gas having a flow profile determined based on the inspiration flow profile; and

supplying an nitric oxide-containing gas to the delivery means, the nitric oxide-containing gas having a flow profile that is less than the oxygen-containing gas flow profile at the onset 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 throughout inspiration.

2. A method according to claim 1, further including the step of monitoring the concentration of one or more of the following gases prior to the delivery means:

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 such that the oxygen-containing gas purges the inspiration limb of nitric oxide-containing gas.

4. A method according to claim 1, wherein the delivery means is a nasal cannula.

5. A method according to claim 1, wherein the delivery means is a face mask.

6. A method according to claim 1, wherein a delivery means is a transtracheal catheter.

7. 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 an inspiration flow profile for an individual breath;

supplying an oxygen-containing gas to the delivery means, the oxygen-containing gas having a flow profile determined based on the inspiration profile; and

supplying an nitric oxide-containing gas to the delivery means, the nitric oxide-containing gas having a flow profile that is less than the oxygen-containing gas flow profile at the onset 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 inspiration.

8. A method according to claim 7, wherein the method further includes the step of monitoring the concentration of one or more of the following gases prior to the delivery means:

oxygen, nitric oxide, and nitrogen dioxide.

9. A method according to claim 7, wherein the flow profile of the nitric oxide-containing gas is zero at the beginning of inspiration and the flow profile of the oxygen-containing gas is positive.

10. A method according to claim 7, wherein the delivery means is a nasal cannula.

11. A method according to claim 7, wherein the delivery means is a face mask.

12. A method according to claim 7, wherein the delivery means is a transtracheal catheter.

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

setting a desired inspiration flow profile in the controller;

varying a 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; and

varying a 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, said flow profile of the nitric oxide-containing gas being proportionally less than the flow profile of the oxygen-containing gas throughout patient inspiration.

14. A method according to claim 13, 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 the flow profile of the oxygen-containing gas is greater than zero such that the oxygen-containing gas purges the inspiration limb of nitric oxide-containing gas.

15. A method according to claim 13, 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 such that the oxygen-containing gas purges the inspiration limb of nitric oxide-containing gas.

16. A method according to claim 13, 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, wherein when the nitric oxide-containing gas flow reaches zero and the flow profile of the oxygen-containing gas is greater than zero the oxygen-containing gas purges the inspiration limb of nitric oxide-containing gas.

17. A method according to claim 13, further including the step of monitoring the concentration of one or more of the following gases in the inspiration limb:

oxygen, nitric oxide, and nitrogen dioxide.

18. A method according to claim 13, further comprising the step of truncating the flow profile of the nitric oxide-containing gas to zero near the end of patient inspiration.

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

setting a desired inspiration flow profile in the controller;

varying a 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; and

varying a 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 the oxygen-containing gas flow profile in the onset of inspiration, wherein the difference between the flow profiles of the oxygen-containing gas and the nitric oxide-containing gas progressively increases throughout inspiration.

20. A method according to claim 19, 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 such that the oxygen-containing gas purges the inspiration limb of nitric oxide-containing gas.

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

setting a desired inspiration flow profile in the controller;

varying a 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; and

varying a 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, the nitric oxide-containing gas having a flow profile that is 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 inspiration.

22. A method according to claim 21, wherein the flow profile of the nitric oxide-containing gas is zero at the beginning of inspiration and the flow profile of the oxygen-containing gas is positive.

23. A method according to claim 21, further including the step of monitoring the concentration of one or more of the following gases in the inspiration limb:

oxygen, nitric oxide, and nitrogen dioxide.

24. A method of delivering a steady concentration of nitric oxide to a spontaneously breathing patient via delivery means having an inspiration limb comprising the steps of:

detecting the onset of inspiration;

determining an inspiration flow profile for an individual breath;

supplying an oxygen-containing gas to the delivery means, the oxygen-containing gas having a flow profile determined based on 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 proportionally less than the flow profile of the oxygen-containing gas throughout inspiration; and

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 such that the oxygen-containing gas purges the inspiration limb of nitric oxide-containing gas.

25. A method of delivering a steady concentration of nitric oxide to a spontaneously breathing patient via delivery means having an inspiration limb comprising the steps of:

detecting the onset of inspiration;

determining an inspiration flow profile for an individual breath;

supplying an oxygen-containing gas to the delivery means, the oxygen-containing gas having a flow profile determined based on 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 proportionally less than the flow profile of the oxygen-containing gas throughout inspiration; and

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 such that the oxygen-containing gas purges the inspiration limb of nitric oxide-containing gas.

26. A method of delivering a steady concentration of nitric oxide to a spontaneously breathing patient via delivery means having an inspiration limb comprising the steps of:

detecting the onset of inspiration;

determining an inspiration flow profile for an individual breath;

supplying an oxygen-containing gas to the delivery means, the oxygen-containing gas having a flow profile determined based on 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 proportionally less than the flow profile of the oxygen-containing gas throughout inspiration; and

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, wherein when the nitric oxide-containing gas flow reaches zero and the flow profile of the oxygen-containing gas is greater than zero the oxygen-containing gas purges the inspiration limb of nitric oxide-containing gas.