IP Library Granted Patent US 10,195,380
Granted Patent B2
US 10,195,380 · App. 15/341,262 · Granted Feb 5, 2019

Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide

Inventors: Craig R. Tolmie (Stoughton, WI); Jeff Milsap (Cambridge, WI); Jaron M. Acker (Madison, WI)
Assignee: Mallinckrodt Hospital Products IP Limited
A61M16/0051A61M16/0003A61M16/024A61M16/085A61M16/1005A61M16/12A61M16/201G01N27/4163G01N33/0006G01N33/0008G01N33/0037A61M16/16A61M2016/102A61M2016/1035A61M2202/0275A61M2205/18A61M2205/27A61M2205/33A61M2205/502A61M2205/52A61M2205/581A61M2205/583A61M2205/70A61M2205/702Y02A50/245
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Quick Facts
Patent No.
US 10,195,380
App. No.
15/341,262
Granted
Feb 5, 2019
Kind
B2
Abstract

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. 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 reduce the amount of times the sensor goes offline. Systems and methods may factor 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.

Claims (45)

1. A method for delivering notifications of a calibration status for a sensor associated with a therapeutic gas delivery device, the method comprising:

storing in memory a baseline calibration value, slope, and calibration schedule; monitoring a patient intake of therapeutic gas with the sensor;

delivering, via the therapeutic gas delivery device, a predetermined dosage of therapeutic gas to the patient;

measuring a concentration of therapeutic gas from the delivered predetermined dosage;

retrieving, from memory, the baseline calibration value, slope and calibration schedule;

performing a zero calibration according to the calibration schedule, wherein the zero calibration includes exposing the sensor to a zero concentration of the therapeutic gas and adjusting the baseline calibration value according to a sensor output value during the zero calibration;

determining, after a predetermined number of zero calibration attempts, that the zero calibration has failed; and

notifying a user that the zero calibration has failed.

2. The method of claim 1 wherein the therapeutic gas is nitric oxide.

3. The method of claim 1 wherein the user is notified with an alarm.

4. The method of claim 1 wherein the notifying includes displaying a message on a display screen.

5. The method of claim 1 wherein performing the zero calibration further comprises notifying the user that the zero calibration is currently in effect.

6. The method of claim 5 wherein the notifying the user further comprises displaying a notification that the measuring of therapeutic gas concentration is off-line.

7. The method of claim 1 wherein the predetermined number of zero calibration attempts is three.

8. The method of claim 7 wherein the three zero calibration attempts include a first initial calibration attempt, and two re-try zero calibration attempts.

9. The method of claim 8 wherein, after the first initial zero calibration attempt, the method further comprises re-trying the zero calibration attempt after a predetermined period of time has passed.

10. A method for delivering notifications of a calibration status for a sensor associated with a nitric oxide delivery device, the method comprising:

storing in memory a baseline calibration value, slope, and calibration schedule; monitoring a patient intake of nitric oxide with the sensor;

delivering, via the nitric oxide delivery device, a predetermined dosage of nitric oxide to the patient;

measuring a concentration of nitric oxide from the delivered predetermined dosage;

retrieving, from memory, the baseline calibration value, slope and calibration schedule;

performing a zero calibration according to the calibration schedule, wherein the zero calibration includes exposing the sensor to a zero concentration of the nitric oxide and adjusting the baseline calibration value according to a sensor output value during the calibration;

determining, after a zero calibration attempt, that calibration has failed;

notifying a user that the zero calibration has failed; and

re-attempting the zero calibration after a predetermined period of time.

11. The method of claim 10 wherein upon completion of the zero calibration, the method further comprises determining an actual concentration of nitric oxide delivered in the predetermined dosage to compensate for sensor drift by adjusting the value of the measured concentration based on the adjusted baseline value and the slope.

12. The method of claim 10 further comprising setting a maximum number of allowable zero calibration re-attempts.

13. The method of claim 12 wherein after the maximum number of allowable zero calibration re-attempts, the method further comprises performing a calibration lockout.

14. The method of claim 13 wherein the calibration lockout further comprises notifying the user with an alarm.

15. The method of claim 10 wherein the zero calibration failed because of an improperly functioning valve.

16. The method of claim 10 further comprising determining, after the re-attempted zero calibration, that the zero calibration failed as a result of both zero calibration attempts producing sensor output values outside an allowable threshold value range.

17. A method for delivering notifications of a calibration status for a sensor associated with a nitric oxide delivery device, the method comprising:

storing in memory a baseline calibration value, slope, and calibration schedule;

monitoring a patient intake of nitric oxide with the sensor;

delivering, via the nitric oxide delivery device, a predetermined dosage of nitric oxide to the patient;

measuring a concentration of nitric oxide from the delivered predetermined dosage;

retrieving, from memory, the baseline calibration value, slope and calibration schedule;

performing a zero calibration according to the calibration schedule, wherein the calibration includes exposing the sensor to a zero concentration of the nitric oxide and adjusting the baseline calibration value according to a sensor output value during the calibration;

determining, after a zero calibration attempt, that the zero calibration has failed;

determining that a sensor output values is outside an allowable threshold value range; and

re-attempting the zero calibration after a predetermined period of time;

transmitting a notification to a user that calibration has failed.

18. The method of claim 17 wherein the notification includes displaying the notification during the performing of the zero calibration, and further includes displaying the notification for an additional period of time after the performing of the zero calibration is completed.

19. The method of claim 18 wherein the additional period of time corresponds to an amount of time for the sensor to settle.

20. The method of claim 18 wherein the nitric oxide sensor is exposed to the gas having a zero concentration of nitric oxide for a predetermined interval before the calibration line is adjusted.

Assignments (21)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2026
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED COMPANY
Reel/Frame 075393/0608 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 73375 FRAME 395. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 075021/0263 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 72331 FRAME 1. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 075021/0204 →
SECURITY INTEREST Recorded Oct 28, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 073375/0395 →
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: SPECGX LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
SECURITY INTEREST Recorded Aug 1, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 072331/0001 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 060434, FRAME 0536 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; VTESSE LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; SUCAMPO PHARMA AMERICAS LLC
Reel/Frame 065601/0347 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 043601, FRAME 0025 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065610/0233 →
SECURITY INTEREST Recorded Nov 15, 2023
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 065595/0376 →
RELEASE OF SECURITY INTERESTS IN PATENTS AT REEL 060389/FRAME 0913 Recorded Nov 15, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0465 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jun 22, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 060434/0536 →
SECURITY INTEREST Recorded Jun 17, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 060389/0913 →
RELEASE OF SECURITY INTEREST Recorded Jun 17, 2022
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS, INC.; MALLINCKRODT LLC; MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY); SPECGX LLC; STRATATECH CORPORATION; VTESSE LLC (F/K/A VTESSE INC.)
Reel/Frame 060389/0839 →
SECURITY INTEREST Recorded Dec 10, 2019
From: MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 051256/0829 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Aug 18, 2017
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 043601/0025 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 2, 2016
From: TOLMIE, CRAIG R.; MILSAP, JEFF; ACKER, JARON M.
To: INO THERAPEUTICS LLC
Reel/Frame 040200/0857 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 2, 2016
From: INO THERAPEUTICS LLC
To: THERAKOS, INC.
Reel/Frame 040201/0045 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 2, 2016
From: THERAKOS, INC.
To: MALLINCKRODT CRITICAL CARE FINANCE INC.
Reel/Frame 040201/0139 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 2, 2016
From: MALLINCKRODT CRITICAL CARE FINANCE INC.
To: MALLINCKRODT PHARMA IP TRADING DAC
Reel/Frame 040201/0276 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 2, 2016
From: MALLINCKRODT PHARMA IP TRADING DAC
To: MALLINCKRODT IP
Reel/Frame 040201/0505 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 2, 2016
From: MALLINCKRODT IP
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 040201/0843 →
Continuity (4)
Continuation 15010999 · Jan 29, 2016
Continuation 14626409 · Feb 19, 2015
Provisional Application 61941725 · Feb 19, 2014
Related Publication 20170072157A1 · Mar 16, 2017