IP Library Granted Patent US 9,956,364
Granted Patent B2
US 9,956,364 · App. 15/341,142 · Granted May 1, 2018

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
A61M16/0051A61M16/0003A61M16/085A61M16/1005A61M16/12A61M16/201G01N27/4163G01N33/0006G01N33/0008G01N33/0037A61M16/16A61M2016/102A61M2016/1035A61M2202/0275A61M2205/18A61M2205/27A61M2205/33A61M2205/502A61M2205/52A61M2205/581A61M2205/583A61M2205/70A61M2205/702
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 9,956,364
App. No.
15/341,142
Granted
May 1, 2018
Kind
B2
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 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 (53)

1. A method for compensating for sensor drift in a nitric oxide delivery system, the method comprising:

storing, in memory associated with the nitric oxide delivery system, a baseline calibration value and a calibration schedule;

initiating a boot-up sequence of the nitric oxide delivery system;

performing a baseline calibration after initiating the boot-up sequence;

receiving a checkout instruction from a user, wherein the checkout instruction is input by the user during the boot-up sequence;

running the checkout, wherein the checkout is run during, and in parallel with, the baseline calibration, wherein the checkout requires access to a gas monitor associated with the nitric oxide delivery system;

verifying, during an attempt to access the gas monitor during the checkout, that the baseline calibration has completed; and

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

wherein the calibration schedule is modified based upon a change in the predetermined dosage of nitric oxide being delivered to the patient, and

wherein a calibration, according to the calibration schedule, occurs with greater frequency as the change in the predetermined dosage is larger.

2. The method of claim 1 wherein if the baseline calibration has not completed, the method further comprises notifying the user that delivery of nitric oxide to the patient must be postponed until the baseline calibration has completed.

3. The method of claim 2 wherein the user is further prevented from proceeding to a next step via notifying the user by displaying a notification that the measuring of the nitric oxide gas concentration is off-line and includes displaying notification for an additional period of time after performing the calibration.

4. The method of claim 3 wherein the next step comprises performing delivery and performance monitoring tests.

5. The method of claim 4 wherein the delivery and performance monitoring tests are performed with the gas monitor.

6. The method of claim 1 wherein if it is verified that the baseline calibration has completed, the system is operable to allow the user to proceed to a next step.

7. The method of claim 1 further comprising:

determining that the sensor is calibrated; and

determining that the baseline value stored in memory is accurate.

8. The method of claim 1 wherein the baseline calibration begins before a user enters an initial set dose.

9. The method of claim 1 wherein the baseline calibration completes before a user enters an initial set dose.

10. The method of claim 1 wherein the baseline calibration is performed to reset the baseline calibration value.

11. The method of claim 1 wherein the baseline calibration is performed to compensate for sensor desaturation.

12. The method of claim 1 wherein the baseline calibration is performed upon powering on the nitric oxide delivery system.

13. The method of claim 1 wherein the baseline calibration is performed prior to initiating a therapy session.

14. The method of claim 1 further comprising performing a default calibration upon boot-up, wherein the default calibration is performed every 24 hours.

15. A method for compensating for sensor drift in a nitric oxide delivery system, the method comprising:

storing, in memory associated with the nitric oxide delivery system, a baseline calibration value and a calibration schedule;

initiating a boot-up sequence of the nitric oxide delivery system;

performing a baseline calibration after initiating the boot-up sequence;

receiving a checkout instruction from a user, wherein the checkout instruction is input by the user during the boot-up sequence;

running the checkout, wherein the pre-use checkout is run during, and in parallel with, the baseline calibration, and wherein the checkout requires access to a gas monitor associated with the nitric oxide delivery system;

verifying, during an attempt to access the gas monitor during the pre-use checkout, that baseline calibration has not completed;

notifying the user that delivery of nitric oxide to the patient must be postponed until baseline calibration has been completed; and

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

wherein the calibration schedule is modified based upon a change in the predetermined dosage of nitric oxide being delivered to the patient, and

wherein a calibration, according to the calibration schedule, occurs with greater frequency as the change in the predetermined dosage is larger.

16. The method of claim 15 wherein the user is prevented from performing delivery and monitoring performance tests until baseline calibration has completed via notifying the user by displaying a notification that the measuring of the nitric oxide gas concentration is off-line and includes displaying notification for an additional period of time after performing the calibration.

17. The method of claim 15 further comprising:

determining that the sensor is calibrated; and

determining that the baseline value stored in memory is accurate.

18. The method of claim 15 wherein the baseline calibration begins before a user enters an initial set dose.

19. A method for compensating for sensor drift in a nitric oxide delivery system, the method comprising:

storing, in memory associated with the nitric oxide delivery system, a baseline calibration value and a calibration schedule;

initiating a boot-up sequence of the nitric oxide delivery system;

performing a baseline calibration after initiating the boot-up sequence;

receiving a checkout instruction from a user, wherein the checkout instruction is input by the user during the boot-up sequence;

verifying, during an attempt to access the gas monitor during the checkout, that baseline calibration has not completed;

notifying the user that delivery of nitric oxide to the patient must be postponed until baseline calibration has been completed, wherein the notifying includes displaying a notification that the measuring of the nitric oxide gas concentration is off-line and includes displaying notification for an additional period of time after the performing of the calibration is completed;

preventing the checkout from running until the baseline calibration has completed; and

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

wherein the calibration schedule is modified based upon a change in the predetermined dosage of nitric oxide being delivered to the patient, and

wherein a calibration, according to the calibration schedule, occurs with greater frequency as the change in the predetermined dosage is larger.

20. The method of claim 19 wherein the baseline calibration is performed upon powering on the nitric oxide delivery system.

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 20170074845A1 · Mar 16, 2017