IP Library Granted Patent US 12,138,396
Granted Patent B2
US 12,138,396 · App. 16/537,955 · Granted Nov 12, 2024

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 PHARMACEUTICALS IRELAND LIMITED
A61M16/12A61M16/0051A61M16/024A61M2016/0039A61M16/0666A61M16/085A61M2016/102A61M2202/0275A61M2205/16A61M2205/18A61M2205/3334A61M2205/502A61M2205/581A61M2205/583
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Quick Facts
Patent No.
US 12,138,396
App. No.
16/537,955
Granted
Nov 12, 2024
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 a therapeutic gas to a patient, the apparatus comprising:

a therapeutic gas injector module comprising:

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

a second inlet in fluid communication with a breathing gas delivery system providing a flow of a breathing gas; and

an outlet to supply a combined flow of the breathing gas and the therapeutic gas to the patient;

a control circuit including a first flow sensor to measure the flow of the breathing gas from the breathing gas delivery system, wherein the control circuit comprises a backup mode in which a known constant flow of the therapeutic gas is independent of a breathing gas flow rate, wherein when the control circuit is in the backup mode, it is operable to deliver the known constant flow of the therapeutic gas and estimate a backup dose based on the known constant flow of the therapeutic gas and the measured flow of the breathing gas, wherein the control circuit is operable to store a breathing gas flow rate history; and

a display, in communication with the control circuit, that provides the estimate of the backup dose,

wherein the display is further configured to display the breathing gas flow rate history, wherein the breathing gas flow rate history comprises a peak and/or average breathing gas flow rate for a period of time;

wherein the display is further configured to display a chart and/or graphic comprising a plurality of breathing gas flow rates and a predicted dose for each of the plurality of breathing gas flow rates.

2. The apparatus of claim 1 , wherein the control circuit assigns a set flow rate based on the constant flow of the therapeutic gas.

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

4. The apparatus of claim 3 , wherein the visual and/or numeric indication of the measured flow of the breathing gas includes one or more of volumetric flow rate, tidal volume, and/or minute ventilation.

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

6. The apparatus of claim 3 , wherein the measured flow of the 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.

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

8. The apparatus of claim 7 , wherein the ventilation apparatus comprises a user input operable to set a certain flow rate or pressure control to achieve a desired therapeutic gas concentration for the backup mode.

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

providing a flow of a breathing gas;

providing a flow of the therapeutic gas comprising nitric oxide;

measuring the flow of the breathing gas to obtain a measured flow of the breathing gas;

obtaining a known constant flow of the 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 the therapeutic gas to the patient;

storing a breathing gas flow rate history;

estimating, via a backup mode in which the known constant flow of the therapeutic gas is independent of a breathing gas flow rate, a backup dose of nitric oxide based on the measured flow of breathing gas and the known constant flow of therapeutic gas;

displaying the estimated backup dose; and

displaying the breathing gas flow rate history, wherein the breathing gas flow rate history comprises a peak and/or average breathing gas flow rate for a period of time;

displaying a chart and/or graphic comprising a plurality of breathing gas flow rates and a predicted dose for each of the plurality of breathing gas flow rates.

10. The method of claim 9 , wherein the known constant flow of the therapeutic gas is a set flow rate.

11. The method of claim 9 , further comprising displaying the measured flow of the breathing gas.

12. The method of claim 11 , wherein displaying the measured flow of the breathing gas includes displaying one or more of volumetric flow rate, tidal volume, and/or minute ventilation.

13. The method of claim 11 , wherein the measured flow of the 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.

14. The apparatus of claim 1 , wherein the control circuit is further configured to store an estimated backup dose history and the display is configured to display the estimated backup dose history for a period of time.

15. The method of claim 9 , the method further comprising storing an estimated backup dose history and displaying the estimated backup dose history for a period of time.

Assignments (17)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2026
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED COMPANY
Reel/Frame 075393/0361 →
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 051231, FRAME 0961 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 065609/0811 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2021
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 056433/0640 →
CHANGE OF NAME Recorded Jun 3, 2021
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 056476/0162 →
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 Dec 9, 2019
From: MALLINCKRODT LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT PHARMA IP TRADING D.A.C.
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 051231/0961 →
Continuity (4)
Continuation 13800287 · Mar 13, 2013
Continuation In Part 13671057 · Nov 7, 2012
Provisional Application 61556525 · Nov 7, 2011
Related Publication 20190374739A1 · Dec 12, 2019
Cited By (1)
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