Claims for Patent: 9,279,794

Summary for Patent: 9,279,794

Title:	Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
Abstract:	Described are systems and methods for compensating long term sensitivity drift of catalytic type electrochemical gas sensors used in systems for delivering therapeutic nitric oxide (NO) gas to a patient by compensating for drift that may be specific to the sensors atypical use in systems for delivering therapeutic nitric oxide gas to a patient. In at least some instances, the long term sensitivity drift of catalytic type electrochemical gas sensors can be addressed using calibration schedules, which can factor in the absolute change in set dose of NO being delivered to the patient that can drive one or more baseline calibrations. The calibration schedules can be used reduce the amount of times the sensor goes offline. Systems and methods described may factor in in actions occurring at the delivery system and/or aspects of the surrounding environment, prior to performing a baseline calibration, and may postpone the calibration and/or rejected using the sensor's output for the calibration.
Inventor(s):	Tolmie; Craig R. (Stoughton, WI), Milsap; Jeff (Cambridge, WI), Acker; Jaron M. (Madison, WI)
Assignee:	Mallinckrodt Hospital Products IP Limited (Dublin, IE)
Application Number:	14/626,409
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,279,794
Patent Claims:	1. A method for compensating for output drift of an electrochemical gas sensor exposed to nitric oxide in a controlled environment comprising: establishing, via a setting in a system controller, a dosage of a nitric oxide to be delivered to a patient; delivering, via a flow control valve, a therapeutic gas comprising nitric oxide to a breathing circuit for delivery to the patient; identifying a change in the setting the system controller; identifying, via the system controller, a sensor recalibration schedule stored in a system controller memory in response to the identified change; identifying, via the system controller, a time for executing a calibration from the sensor recalibration schedule stored in the system controller memory; detecting, via the system controller, if an alarm is active or has been active within a predetermined timeframe at the time the calibration is to be executed, wherein the calibration is postponed if the active alarm is detected or has been detected within the predetermined timeframe, and the calibration is executed if the active alarm is not detected or has not been detected within the predetermined timeframe; implementing, via the system controller, the sensor recalibration schedule identified; continuously measuring, via a first nitric oxide sensor, a concentration of the nitric oxide in the breathing circuit; communicating a signal representative of the nitric oxide concentration from the first nitric oxide sensor to the system controller over a communication path; and determining a response by the first nitric oxide sensor to the nitric oxide concentration after the change in the setting in the system controller. 2. The method of claim 1, which further comprises interrupting the continuous measuring of the nitric oxide concentration when indicated by the identified sensor recalibration schedule; exposing the first nitric oxide sensor to a gas having a zero concentration of nitric oxide for a period of time sufficient to detect the output value indicative of the zero concentration; and determining the response by the first nitric oxide sensor to the gas having a zero concentration of the nitric oxide. 3. The method of claim 2, wherein the sensor recalibration schedule comprises a set of values representing intended intervals between interruptions of the continuous measuring of the nitric oxide concentration. 4. The method of claim 3, wherein the intended intervals are larger for a smaller change in the setting in the system controller. 5. The method of claim 2, which further comprises storing the response of the first nitric oxide sensor to the gas having a zero concentration of nitric oxide in the system controller memory. 6. The method of claim 5, which further comprises accessing a slope of a previous calibration line stored in the system controller memory, and generating a new calibration line using the stored response of the first nitric oxide sensor to the gas having the zero concentration of nitric oxide and the slope of the previous calibration line. 7. The method of claim 2, which further comprises (i) detecting the presence of interfering gas, and postponing execution of the calibration by a predetermined time period if interfering gas is detected and/or (ii) detecting if a user is interacting or has interacted with the therapeutic gas delivery system within a predetermined timeframe at the time the calibration is to be executed. 8. The method of claim 2, which further comprises displaying a message to a user when measuring the concentration of nitric oxide in the breathing circuit with the first nitric oxide sensor is interrupted to execute the calibration. 9. The method of claim 2, which further comprises measuring the concentration of nitric oxide in the breathing circuit with a second nitric oxide sensor when measuring the concentration of nitric oxide in the breathing circuit with the first nitric oxide sensor is interrupted, so a measure of the nitric oxide concentration is displayed to a user during recalibration. 10. The method of claim 9, which further comprises exposing the second nitric oxide sensor to the gas having a zero concentration of the nitric oxide for the period of time sufficient to de-saturate and/or detect the output value indicative of the zero concentration after exposing the first nitric oxide sensor to the gas having a zero concentration of nitric oxide for the period of time sufficient to de-saturate and/or detect the output value indicative of the zero concentration, and comparing the output value from the second nitric oxide sensor to the output value of the first nitric oxide sensor to determine the difference in drift between the first and second nitric oxide sensors. 11. The method of claim 1, which further comprises identifying the type of first nitric oxide sensor continuously measuring a concentration of nitric oxide in the breathing circuit; storing the type of first nitric oxide sensor in the system controller; and utilizing the type of first nitric oxide sensor in identifying the sensor recalibration schedule. 12. The method of claim 11, wherein the first nitric oxide sensor is a three terminal electrochemical nitric oxide gas sensor or a four terminal electrochemical nitric oxide gas sensor. 13. The method of claim 12, which further comprises selecting a source of ambient air to flow to the first nitric oxide sensor when interrupting the continuous measuring of the nitric oxide concentration in the breathing circuit without disconnecting a sample line from an inspiratory side of the patient breathing circuit. 14. The method of claim 12, which further comprises switching a valve connected to and in fluid communication with the patient breathing circuit to allow ambient air to flow to the first nitric oxide sensor when interrupting the continuous measuring of the nitric oxide concentration in the breathing circuit without disconnecting a sample line from an inspiratory side of the patient breathing circuit. 15. The method of claim 14, which further comprises verifying the valve has switched to allow ambient air to flow to the sensor. 16. The method of claim 1, which further comprises postponing execution of the calibration by a predetermined time period, and detecting if an alarm is active or has been active within the predetermined timeframe after the predetermined time period has elapsed, wherein the calibration is postponed if the active alarm is detected or has been detected within the predetermined timeframe, and the calibration is executed if the active alarm is not detected or has not been detected within the predetermined timeframe. 17. A method for compensating for output drift of an electrochemical gas sensor exposed to nitric oxide in a controlled environment, comprising: delivering, via a flow control valve, a therapeutic gas comprising nitric oxide to a breathing circuit for delivery to a patient in need thereof; detecting, via a system controller, a change in set dose of the therapeutic gas; selecting, via the system controller, a sensor recalibration schedule stored in a system controller memory in response to the change in set dose; identifying, via a system controller, a time for executing a calibration from a sensor recalibration schedule stored in a system controller memory; detecting, via the system controller, if an alarm is active or has been active within a predetermined timeframe at the time the calibration is to be executed, wherein the calibration is postponed if the active alarm is detected or has been detected within the predetermined timeframe; detecting, via the system controller, if a user is interacting or has interacted with the therapeutic gas delivery system within a predetermined timeframe at the time the calibration is to be executed, wherein the calibration is postponed if the user is interacting or has interacted with the therapeutic gas delivery system within the predetermined timeframe; executing, via the system controller, the calibration (i) if the active alarm is not detected or has not been detected within the predetermined timeframe, and (ii) if the user is not interacting or has not interacted with the therapeutic gas delivery system within the predetermined timeframe. 18. A method for compensating for output drift of an electrochemical gas sensor exposed to nitric oxide in a controlled environment, comprising: delivering, via a flow control valve, a therapeutic gas comprising nitric oxide to a breathing circuit for delivery to a patient in need thereof; detecting, via a system controller, a change in set dose of the therapeutic gas; selecting, via the system controller, a sensor recalibration schedule stored in a system controller memory in response to the change in set dose; identifying, via the system controller, a time for executing a calibration from the selected sensor recalibration schedule; detecting, via the system controller, if an alarm is active or has been active within a predetermined timeframe at the time the calibration is to be executed, wherein the calibration is postponed if the active alarm is detected or has been detected within the predetermined timeframe; executing, via the system controller, the calibration if the active alarm is not detected or has not been detected within the predetermined timeframe; and displaying, via a display, a message to a user, when executing the calibration, indicating that the calibration is in effect and/or recording in an electronic medical record (EMR) the occurrence of the calibration to inform the user of the system's activity.