Apparatus and method for monitoring nitric oxide delivery

• US 10,426,913 B2
• Filed: 03/13/2013
• Issued: 10/01/2019
• Est. Priority Date: 11/07/2011
• Status: Active Grant

• Current Assignee: Mallinckrodt Critical Care Finance Inc (Mallinckrodt plc), Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc), Therakos, Inc (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Hospital Products IP Ltd. (Mallinckrodt plc)
• Inventors: Tolmie, Craig R., Schnitman, Robert, Medicis, Joseph J., Potenziano, Jim, Acker, Jaron, Schmidt, Jeffrey
• Primary Examiner(s): Ho, Tan-Uyen T
• Assistant Examiner(s): Murphy, Victoria
• Application Number:
  US13/800,287
• Publication Number:
  US 20130192595A1
• Time in Patent Office: 2,393 Days
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/085 Gas sampling
• CPC Class Codes: A61M 16/12 by mixing different gases
• 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 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2205/16 with back-up system in case of failure
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback

Abstract

Described is an apparatus for monitoring nitric oxide delivery, wherein such apparatus comprises a display that provides a visual and/or numeric indication of the calculated dose of nitric oxide. Also described is a method of monitoring nitric oxide delivery, wherein the breathing gas flow rate and therapeutic gas flow rate are measured and used to determine the calculated dose of nitric oxide, which is then displayed. In some embodiments, an alert is provided when the calculated dose rises above or falls below a predetermined level or range.

Claims

1. An apparatus to deliver therapeutic gas to a patient, the apparatus comprising:

a first inlet to be placed in fluid communication with a therapeutic gas supply providing a continuous flow of nitric oxide at a therapeutic gas supply concentration;

a second inlet to be placed in fluid communication with a breathing gas delivery system providing a continuous flow of a breathing gas to the patient;

a therapeutic gas injector module to be placed in fluid communication with the first inlet and the second inlet to provide a combined continuous flow of breathing gas and therapeutic gas;

an outlet in fluid communication with the therapeutic gas injector module to supply the combined continuous flow of breathing gas and therapeutic gas to the patient;

a control circuit including a first flow sensor to measure the continuous flow of breathing gas from the breathing gas delivery system and a second flow sensor to measure the continuous flow of therapeutic gas, wherein the control circuit determines a calculated dose of nitric oxide based on the measured flow of breathing gas and either the measured flow of therapeutic gas or a known continuous flow of therapeutic gas; and

a display in communication with the control circuit that provides a visual and/or numeric indication of the calculated dose of nitric oxide, wherein the visual and/or numeric indication of the calculated dose of nitric oxide is provided as a percentage of a desired delivery concentration to be delivered to the patient, wherein the desired delivery concentration is set by a user; and

wherein the visual and/or numeric indication of the calculated dose of nitric oxide as the percentage of the desired delivery concentration is indicated on the display as being in one of a target delivery region, an under-delivery of nitric oxide region, and an over-delivery of nitric oxide region.

2. The apparatus of claim 1, wherein the calculated dose of nitric oxide is one or more of an average calculated dose, an instantaneous calculated dose, a maximum calculated dose and/or a minimum calculated dose.

3. The apparatus of claim 1, further comprising an indicator that provides an alert when the flow of breathing gas or calculated dose of nitric oxide rises above or falls below a predetermined level.

4. The apparatus of claim 3, wherein the alert includes one or more of an audible alert, a visual alert and/or a text alert.

5. The apparatus of claim 3, wherein the indicator is an icon or graphic on the display that provides a visual and/or numeric indication of the measured flow of breathing gas.

6. The apparatus of claim 1, wherein the display also provides a visual and/or numeric indication of the measured flow of breathing gas.

7. The apparatus of claim 6, wherein the visual and/or numeric indication of the measured flow of breathing gas includes one or more of volumetric flow rate, tidal volume, and/or minute ventilation.

8. The apparatus of claim 6, wherein the measured flow of breathing gas is one or more of an average flow rate, an instantaneous flow rate, a peak flow rate and/or a minimum measured flow rate.

9. The apparatus of claim 1, wherein the breathing gas delivery system comprises a ventilation apparatus.

10. The apparatus of claim 1, wherein the control circuit further comprises clinical decision support software to reset any upper and lower limits of maximum and minimum calculated dose to avert shutdown of the apparatus.

11. The apparatus of claim 1, wherein the display further provides a chart that provides a predicted nitric oxide concentration as a function of the measured flow of breathing gas.

12. A method of monitoring the delivery of therapeutic gas to a patient comprising:

providing a continuous flow of breathing gas;

providing a continuous flow of therapeutic gas comprising nitric oxide;

measuring the continuous flow of breathing gas to obtain a measured flow of breathing gas;

measuring the continuous flow of therapeutic gas comprising nitric oxide to obtain a measured flow of therapeutic gas or obtaining a known continuous flow of therapeutic gas;

receiving from a user a desired delivery concentration of the therapeutic gas to be delivered to the patient;

delivering the breathing gas and therapeutic gas to the patient;

determining a calculated dose of nitric oxide based on the measured flow of breathing gas and either the measured flow of therapeutic gas or the known continuous flow of therapeutic gas; and

displaying a visual and/or numeric indication of the calculated dose of nitric oxide on a display module, wherein the calculated dose of nitric oxide is provided as a percentage of the desired delivery concentration;

wherein the visual and/or numeric indication of the calculated dose of nitric oxide as the percentage of the desired delivery concentration is indicated on the display as being in one of a target delivery region, an under-delivery of nitric oxide region, and an over-delivery of nitric oxide region.

13. The method of claim 12, further comprising comparing the calculated dose of nitric oxide to a predetermined limit and providing an alert if the calculated dose of nitric oxide is above or below the predetermined limit.

14. The method of claim 13, wherein the alert includes one or more of an audible alert, a visual alert and/or a text alert.

15. The method of claim 13, wherein the predetermined limit comprises a delivery error greater than or equal to about 25%.

16. The method of claim 12, wherein the calculated dose of nitric oxide is one or more of an average calculated dose, an instantaneous calculated dose, a maximum calculated dose and/or a minimum calculated dose.

17. The method of claim 12, further comprising displaying the measured flow of breathing gas.

18. The method of claim 17, wherein displaying the measured flow of breathing gas includes displaying one or more of volumetric flow rate, tidal volume, and/or minute ventilation.

19. The method of claim 17, wherein the measured flow of breathing gas is one or more of an average flow rate, an instantaneous flow rate, a peak flow rate and/or a minimum measured flow rate.