Apparatus and method for monitoring nitric oxide delivery

Patent metadata

Field	Value
Publication number	US-10773046-B2
Application number	US-201715683290-A
Country	US
Kind code	B2
Filing date	Aug 22, 2017
Priority date	Nov 7, 2011
Publication date	Sep 15, 2020
Grant date	Sep 15, 2020

Abstract

Described is an apparatus for monitoring nitric oxide delivery, wherein such apparatus comprises an indicator to inform a user of the apparatus when the flow of breathing gas rises above or falls below a predetermined level or range. Also described is a method of monitoring nitric oxide delivery, wherein the flow of breathing gas is measured and displayed. In some embodiments, an alert is provided when the flow of breathing gas rises above or falls below a predetermined level or range.

First claim

What is claimed is:

1. An apparatus to deliver therapeutic gas to a patient, the apparatus comprising:
a therapeutic gas supply comprising nitric oxide;
a therapeutic gas injector module comprising a first inlet in fluid communication with the therapeutic gas supply, a second inlet in fluid communication with a breathing gas delivery system that provides a breathing gas, and an outlet in fluid communication with the first inlet and the second inlet to supply a mixture of the breathing gas and the therapeutic gas to the patient, the therapeutic gas injector module in communication with the therapeutic gas supply to control the flow of therapeutic gas to the patient and achieve a desired dose of therapeutic gas administered to the patient;
a flow sensor operable to measure the flow of the breathing gas;
a display in communication with the therapeutic gas injector module; and
a control circuit in communication with the therapeutic gas injector module and the display, the control circuit operable to calculate a delivery concentration of the therapeutic gas and operable to send data to the display to produce an indicator to inform the user of the apparatus when the calculated delivery concentration is 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 control circuit includes a CPU and a flow controller.

3. The apparatus of claim 2 , wherein the CPU sends and receives signals to the flow sensor and the flow controller such that the control circuit maintains a minimum flow of therapeutic gas to the patient.

4. The apparatus of claim 3 , wherein the control circuit further comprises clinical decision support software.

5. The apparatus of claim 4 , wherein the clinical decision support software comprises instructions to reset any upper and lower limits of maximum and minimum dose to avert shutdown of the apparatus.

6. The apparatus of claim 2 , wherein the flow of the breathing gas is detected by the flow sensor and the flow of therapeutic gas delivered to the therapeutic gas injector module is controlled by the CPU and flow controller to a achieve the desired dose of the therapeutic gas to the patient based on the detected flow rate of the breathing gas and the concentration of nitric oxide in the therapeutic gas supply.

7. The apparatus of claim 1 , wherein the indicator provides an alert when the flow of breathing gas rises above or falls below a predetermined level.

8. The apparatus of claim 7 , wherein the alert includes one or more of an audible alert, a visual alert and a text alert.

9. The apparatus of claim 7 , wherein the predetermined level is the level at which the apparatus shuts down.

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

11. The apparatus of claim 10 , wherein the visual and/or numeric indication includes one or more of volumetric flow rate, tidal volume, and minute ventilation.

12. The apparatus of claim 10 , wherein the indicator is an icon or graphic on the display that provides the visual and/or numeric indication of the volumetric flow of breathing gas.

13. The apparatus of claim 10 , wherein the volumetric flow of breathing gas is one or more of an average flow rate, an instantaneous flow rate, a peak flow rate and a minimum measured flow rate.

14. The apparatus of claim 10 , wherein the display comprises a visual indication of the calculated delivery concentration of nitric oxide as a percentage of the desired delivery concentration.

15. The apparatus of claim 1 , further comprising a sample block that analyzes the concentration of nitric oxide, oxygen, and/or nitrogen dioxide in the gas mixture.

16. The apparatus of claim 15 , wherein the display provides a visual indication of the concentration of nitric oxide, oxygen, and/or nitrogen dioxide in the gas mixture.

17. The apparatus of claim 15 , wherein the sample block draws a volume of combined therapeutic and breathing gas of less than or equal to 250 mL/min, less than or equal to 100 mL/min, than or equal to 50 mL/min, or than or equal to 20 mL/min.

18. The apparatus of claim 1 , wherein the therapeutic gas injector module is a neo-injector module operable to determine flow rates below 2 L/min.

19. The apparatus of claim 18 , wherein the the second inlet has an inner diameter of 14 mm to 20 mm.

20. The apparatus of claim 18 , wherein the neo-injector module has an internal taper diameter of 4 mm to 7 mm between the second inlet and the outlet.

21. The apparatus of claim 18 , wherein the neo-injector module and flow sensor are adapted to determine flow of breathing gas as low as 0.25 L/min.

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

23. The apparatus of claim 1 , further comprising a therapeutic gas flow sensor operable to measure the flow rate of the therapeutic gas; and a CPU operable to calculate the delivered concentration of the therapeutic gas in the combined flow.

24. The apparatus of claim 1 , wherein the flow sensor is in fluid communication with and downstream of the second inlet and monitors the flow of breathing gas through the therapeutic injector module.

25. The apparatus of claim 1 , wherein the flow sensor is part of the therapeutic injector module.

26. The apparatus of claim 1 , wherein the display provides a visual indication of the nitric oxide concentration in the therapeutic gas supply.

Assignees

• Mallinckrodt Hospital Products Ip Ltd

Inventors

• Schnitman Robert
• Medicis Joseph J
• Potenziano Jim
• Acker Jaron
• Schmidt Jeffrey

Classifications

• A61M16/0051 Primary

  with alarm devices · CPC title

• A61M16/024

  including calculation means, e.g. using a processor · CPC title

• A61M2016/102

  Measuring a parameter of the content of the delivered gas · CPC title

• A61M16/12

  by mixing different gases · CPC title

• A61M2205/18

  with alarm · CPC title