Systems And Methods For Indicating Lifetime Of An NO2-to-NO Reactor Cartridge Used To Deliver NO For Inhalation Therapy To A Patient

• US 20150328429A1
• Filed: 05/14/2015
• Published: 11/19/2015
• Est. Priority Date: 05/14/2014
• Status: Active Grant

• Current Assignee: Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc)
• Original Assignee: INO Therapeutics LLC (Mallinckrodt plc)
• Inventors: Acker, Jaron, Flanagan, Craig, Ridley, Sarah Jayne, Schweighardt, Frank Kenneth, Asif, Muhammad, Greene, Douglas Alan, Sheu, Lien-Lung
• Granted Patent: US 10,525,226 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0063 Compressors
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/161 with means for measuring the humidity
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 2016/003 with a flowmeter
• CPC Class Codes: A61M 2016/1035 the anaesthetic agent concentration
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/584 : having a color code
• CPC Class Codes: A61M 2205/707 : Testing of filters for clogging
• CPC Class Codes: B01D 2253/106 : Silica or silicates
• CPC Class Codes: B01D 2257/404 : Nitrogen oxides other than dinitrogen oxide
• CPC Class Codes: B01D 2259/4533 : for medical purposes
• CPC Class Codes: B01D 53/0415 : Beds in cartridges
• CPC Class Codes: B01D 53/0446 : Means for feeding or distributing gases
• CPC Class Codes: C01B 21/24 : Nitric oxide (NO) C01B21/203 takes precedence

Abstract

The principles and embodiments of the present invention relate to methods and systems for safely providing NO to a recipient for inhalation therapy. There are many potential safety issues that may arise from using a reactor cartridge that converts NO₂ to NO, including exhaustion of consumable reactants of the cartridge reactor. Accordingly, various embodiments of the present invention provide systems and methods of determining the remaining useful life of a NO2-to-NO reactor cartridge and/or a break-through of NO₂, and providing an indication of the remaining useful life and/or break-through.

Claims

1. A system for safely delivering a supply of NO to a recipient, comprising:

a gas source that supplies a gas;

a gas conduit connected to and in fluid communication with the gas source;

a NO₂-to-NO reactor cartridge connected to and in fluid communication with the gas conduit, so as to allow gas to flow from the gas source to an inlet end of the NO₂-to-NO reactor cartridge;

a means of monitoring the functioning of the NO₂-to-NO reactor cartridge operatively associated with the NO₂-to-NO reactor cartridge;

a delivery conduit connected to and in fluid communication with an outlet end of the NO₂-to-NO reactor cartridge that allows NO gas from the NO₂-to-NO reactor cartridge to flow to a recipient;

a computer in electronic communication with the monitoring means over a communication path, wherein the computer is configured to receive electronic signals from the monitoring means and calculate a performance value; and

a regulating means in electronic communication with the computer over a communication path.

2. The system of claim 1, which further comprises a flow meter for measuring the amount of gas entering the NO₂-to-NO reactor cartridge.

3. The system of claim 1, which further comprises a flow meter for measuring the amount of gas being delivered to the recipient.

4. The system of claim 1, which further comprises an NO₂ sensor operationally associated with the delivery conduit to determine the presence of an unacceptable level of NO₂ in the gas being directed to the recipient.

5. The system of claim 1, wherein the gas supplied by the gas source is NO₂ or NO.

6. The system of claim 1, wherein the performance value is calculated and utilized for comparison with a predetermined threshold value, the computer is configured to generate an actuating signal when the performance value falls below the threshold value, and the regulating means is configured to receive an actuating signal from the computer, wherein the regulating means halts the delivery of the gas to a recipient when the actuating signal is received from the computer.

7. The system of claim 6, wherein the NO₂-to-NO reactor cartridge comprises a consumable conversion media, and the threshold value indicates that a predetermined amount of the consumable conversion media has been reached, and wherein the computer is configured to alert a user through a display, an audible alarm, or both that the NO₂-to-NO reactor cartridge is exhausted or compromised.

8. The system of claim 7, wherein the means of monitoring the functioning of the NO₂-to-NO reactor cartridge operatively associated with the NO₂-to-NO reactor cartridge comprises one or more sensor(s) embedded into the consumable conversion media.

9. The system of claim 8, wherein the means of monitoring the functioning of the NO₂-to-NO reactor cartridge operatively associated with the NO₂-to-NO reactor cartridge further comprises a meter configured to detect and/or measure various characteristics of the NO₂-to-NO reactor cartridge and/or gas streams.

10. The system of claim 9, wherein the meter is configured to detect and/or measure the concentration of ascorbic acid, the concentration of dehydroascorbic acid, the concentration of water (H₂O), the concentration of NO₂, the concentration of NO, the concentration of O₂, the concentration of HNO₃, the pH of at least a portion of the NO₂-to-NO reactor cartridge, the redox potentials of chemical species in the NO₂-to-NO reactor cartridge, the mass flow rate of gases, the conductance at the surface of the silica gel, and/or the humidity of incoming and outgoing gases.

11. A method of monitoring the performance of an NO₂-to-NO reactor cartridge which comprises:

incorporating one or more sensor probe(s) into an NO₂-to-NO reactor cartridge comprising a conversion media, wherein the one or more sensor probes are operatively associated with the NO₂-to-NO reactor cartridge and operatively associating at least one meter with the at least one sensor probe.

12. The method of claim 11, which further comprises incorporating the NO₂-to-NO reactor cartridge into an NO delivery system, wherein the NO₂-to-NO reactor cartridge is connected to and in fluid communication with a gas source conduit that is configured to contain and direct a gas from a gas source to the NO₂-to-NO reactor cartridge.

13. The method of claim 12, which further comprises detecting physical and/or chemical characteristics of the conversion media with the sensor probe(s);

measuring the detected physical and/or chemical characteristics with the operatively associated meter;

communicating the measured physical and/or chemical characteristics to a computer; and

monitoring the communicated characteristics with the computer.

14. The method of claim 11, wherein the one or more sensor probe(s) is a flow sensor, a spectrophotometric sensor, a chemical sensor, an electrochemical sensor, a pH sensor, a moisture sensor, or a combination of one or more sensors.

15. The method of claim 14, wherein the one or more sensor probe(s) are operatively associated with the NO₂-to-NO reactor cartridge, and provide chemically and/or physically sampling the NO₂-to-NO reactor cartridge, wherein the sensor probe(s) include an optical fiber, a window, a carbon nanotube, a micro pH electrode, a cannula, a thermistor, a thermocouple, alone or in combination with a color-active agent, a sensitizing reagent, a chemical indicator.

16. The method of claim 14, wherein the one or more sensor probe(s) are operatively associated with the conversion media.

17. The method of claim 16, wherein the conversion media comprises a packing material coated with ascorbic acid, alpha tocopherol, or gamma tocopherol, and a color agent.

18. A system for safely delivering a supply of NO to a recipient, comprising:

a gas source that supplies a gas, wherein the gas is NO₂ or NO;

a gas conduit connected to and in fluid communication with the gas source;

a NO₂-to-NO reactor cartridge connected to and in fluid communication with the gas conduit, so as to allow gas to flow from the gas source to an inlet end of the NO₂-to-NO reactor cartridge;

a means of monitoring the functioning of the NO₂-to-NO reactor cartridge operatively associated with the NO₂-to-NO reactor cartridge;

a delivery conduit connected to and in fluid communication with an outlet end of the NO₂-to-NO reactor cartridge that allows NO gas from the NO₂-to-NO reactor cartridge to flow to a recipient;

a computer in electronic communication with the monitoring means over a communication path, wherein the computer is configured to receive electronic signals from the monitoring means and calculate a performance value for comparison with a predetermined threshold value, and configured to generate an actuating signal when the performance value falls below the threshold value; and

a regulating means in electronic communication with the computer over a communication path, wherein the regulating means is configured to receive an actuating signal from the computer, and wherein the regulating means halts the delivery of the gas to a recipient.

19. The system of claim 18, wherein the NO₂-to-NO reactor cartridge comprises an outer reactor shell, an inlet, an outlet, and a consumable conversion media including solid packing material coated with consumable reactant.

20. The system of claim 18, wherein the gas source is encased within an outer housing.