IP Library Granted Patent US 10,426,913
Granted Patent B2
US 10,426,913 · App. 13/800,287 · Granted Oct 1, 2019

Apparatus and method for monitoring nitric oxide delivery

Inventors: Craig R. Tolmie (Stoughton, WI); Robert Schnitman (Colchester, CT); Joseph J. Medicis (Syracuse, NY); Jim Potenziano (Binghamton, NY); Jaron Acker (New York, NY); Jeffrey Schmidt (Oregon, WI)
Assignee: Mallinckrodt Hospital Products IP Limited
A61M16/12A61M16/0051A61M16/024A61M16/0666A61M16/085A61M2016/0039A61M2016/102A61M2202/0275A61M2205/16A61M2205/18A61M2205/3334A61M2205/502A61M2205/581A61M2205/583
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 10,426,913
App. No.
13/800,287
Granted
Oct 1, 2019
Kind
B2
Abstract

Described is an apparatus for monitoring nitric oxide delivery, wherein such apparatus comprises a display that provides a visual and/or numeric indication of the calculated dose of nitric oxide. Also described is a method of monitoring nitric oxide delivery, wherein the breathing gas flow rate and therapeutic gas flow rate are measured and used to determine the calculated dose of nitric oxide, which is then displayed. In some embodiments, an alert is provided when the calculated dose rises above or falls below a predetermined level or range.

Claims (34)

1. An apparatus to deliver therapeutic gas to a patient, the apparatus comprising:

a first inlet to be placed in fluid communication with a therapeutic gas supply providing a continuous flow of nitric oxide at a therapeutic gas supply concentration;

a second inlet to be placed in fluid communication with a breathing gas delivery system providing a continuous flow of a breathing gas to the patient;

a therapeutic gas injector module to be placed in fluid communication with the first inlet and the second inlet to provide a combined continuous flow of breathing gas and therapeutic gas;

an outlet in fluid communication with the therapeutic gas injector module to supply the combined continuous flow of breathing gas and therapeutic gas to the patient;

a control circuit including a first flow sensor to measure the continuous flow of breathing gas from the breathing gas delivery system and a second flow sensor to measure the continuous flow of therapeutic gas, wherein the control circuit determines a calculated dose of nitric oxide based on the measured flow of breathing gas and either the measured flow of therapeutic gas or a known continuous flow of therapeutic gas; and

a display in communication with the control circuit that provides a visual and/or numeric indication of the calculated dose of nitric oxide, wherein the visual and/or numeric indication of the calculated dose of nitric oxide is provided as a percentage of a desired delivery concentration to be delivered to the patient, wherein the desired delivery concentration is set by a user; and

wherein the visual and/or numeric indication of the calculated dose of nitric oxide as the percentage of the desired delivery concentration is indicated on the display as being 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 calculated dose of nitric oxide is one or more of an average calculated dose, an instantaneous calculated dose, a maximum calculated dose and/or a minimum calculated dose.

3. The apparatus of claim 1 , further comprising an indicator that provides an alert when the flow of breathing gas or calculated dose of nitric oxide rises above or falls below a predetermined level.

4. The apparatus of claim 3 , wherein the alert includes one or more of an audible alert, a visual alert and/or a text alert.

5. The apparatus of claim 3 , wherein the indicator is an icon or graphic on the display that provides a visual and/or numeric indication of the measured flow of breathing gas.

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

7. The apparatus of claim 6 , wherein the visual and/or numeric indication of the measured flow of breathing gas includes one or more of volumetric flow rate, tidal volume, and/or minute ventilation.

8. The apparatus of claim 6 , wherein the measured flow of breathing gas is one or more of an average flow rate, an instantaneous flow rate, a peak flow rate and/or a minimum measured flow rate.

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

10. The apparatus of claim 1 , wherein the control circuit further comprises clinical decision support software to reset any upper and lower limits of maximum and minimum calculated dose to avert shutdown of the apparatus.

11. The apparatus of claim 1 , wherein the display further provides a chart that provides a predicted nitric oxide concentration as a function of the measured flow of breathing gas.

12. A method of monitoring the delivery of therapeutic gas to a patient comprising:

providing a continuous flow of breathing gas;

providing a continuous flow of therapeutic gas comprising nitric oxide;

measuring the continuous flow of breathing gas to obtain a measured flow of breathing gas; measuring the continuous flow of therapeutic gas comprising nitric oxide to obtain a measured flow of therapeutic gas or obtaining a known continuous flow of therapeutic gas;

receiving from a user a desired delivery concentration of the therapeutic gas to be delivered to the patient;

delivering the breathing gas and therapeutic gas to the patient;

determining a calculated dose of nitric oxide based on the measured flow of breathing gas and either the measured flow of therapeutic gas or the known continuous flow of therapeutic gas; and

displaying a visual and/or numeric indication of the calculated dose of nitric oxide on a display module, wherein the calculated dose of nitric oxide is provided as a percentage of the desired delivery concentration;

wherein the visual and/or numeric indication of the calculated dose of nitric oxide as the percentage of the desired delivery concentration is indicated on the display as being in one of a target delivery region, an under-delivery of nitric oxide region, and an over-delivery of nitric oxide region.

13. The method of claim 12 , further comprising comparing the calculated dose of nitric oxide to a predetermined limit and providing an alert if the calculated dose of nitric oxide is above or below the predetermined limit.

14. The method of claim 13 , wherein the alert includes one or more of an audible alert, a visual alert and/or a text alert.

15. The method of claim 13 , wherein the predetermined limit comprises a delivery error greater than or equal to about 25%.

16. The method of claim 12 , wherein the calculated dose of nitric oxide is one or more of an average calculated dose, an instantaneous calculated dose, a maximum calculated dose and/or a minimum calculated dose.

17. The method of claim 12 , further comprising displaying the measured flow of breathing gas.

18. The method of claim 17 , wherein displaying the measured flow of breathing gas includes displaying one or more of volumetric flow rate, tidal volume, and/or minute ventilation.

19. The method of claim 17 , wherein the measured flow of breathing gas is one or more of an average flow rate, an instantaneous flow rate, a peak flow rate and/or a minimum measured flow rate.

Assignments (30)
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: 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
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 049822, FRAME 0674 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 065609/0454 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 035454, FRAME 0768 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 065610/0035 →
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 →
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 →
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 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 →
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 INTELLECTUAL PROPERTY Recorded Jul 22, 2019
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 049822/0674 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: INO THERAPEUTICS LLC
To: THERAKOS, INC.
Reel/Frame 038008/0956 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: MALLINCKRODT IP
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 038009/0016 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: MALLINCKRODT PHARMA IP TRADING DAC
To: MALLINCKRODT IP
Reel/Frame 038009/0058 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: MALLINCKRODT CRITICAL CARE FINANCE INC.
To: MALLINCKRODT PHARMA IP TRADING DAC
Reel/Frame 038038/0009 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: THERAKOS, INC.
To: MALLINCKRODT CRITICAL CARE FINANCE INC.
Reel/Frame 038008/0824 →
SECURITY INTEREST Recorded Apr 19, 2015
From: INO THERAPEUTICS LLC
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 035454/0768 →
RELEASE OF SECURITY INTEREST Recorded Apr 17, 2015
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH
To: INO THERAPEUTICS LLC
Reel/Frame 035453/0487 →
RELEASE OF SECURITY INTEREST Recorded Apr 17, 2015
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH
To: INO THERAPEUTICS LLC
Reel/Frame 035453/0513 →
PATENT SECURITY AGREEMENT (FIRST LIEN) Recorded Mar 11, 2014
From: INO THERAPEUTICS LLC
To: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS ADMINISTRATIVE AGENT
Reel/Frame 032426/0747 →
PATENT SECURITY AGREEMENT (SECOND LIEN) Recorded Mar 11, 2014
From: INO THERAPEUTICS LLC
To: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS ADMINISTRATIVE AGENT
Reel/Frame 032426/0848 →
RELEASE OF SECURITY INTEREST Recorded Feb 18, 2014
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS COLLATERAL AGENT
To: INO THERAPEUTICS LLC
Reel/Frame 032274/0768 →
RELEASE OF SECURITY INTEREST Recorded Feb 14, 2014
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS COLLATERAL AGENT
To: IKARIA INC.; INO THERAPEUTICS LLC
Reel/Frame 032264/0517 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2014
From: TOLMIE, CRAIG R.; SCHNITMAN, ROBERT; MEDICIS, JOSEPH J.; POTENZIANO, JIM; ACKER, JARON; SCHMIDT, JEFFREY
To: INO THERAPEUTICS LLC
Reel/Frame 032079/0222 →
SECURITY AGREEMENT Recorded Jul 10, 2013
From: IKARIA, INC.; IKARIA ACQUISITION INC.; INO THERAPEUTICS LLC
To: CREDIT SUISSE AG, AS COLLATERAL AGENT
Reel/Frame 030764/0549 →
SECURITY AGREEMENT Recorded Jun 5, 2013
From: IKARIA, INC.; INO THERAPEUTICS LLC
To: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH AS COLLATERAL AGENT
Reel/Frame 030557/0948 →
Cited By (5)
US 12,509,349 US 12,522,501 US 12,569,628 US 12,576,234 US 12,606,436