IP Library Granted Patent US 12,478,757
Granted Patent B2
US 12,478,757 · App. 17/685,072 · Granted Nov 25, 2025

Compensating for disruptions in breathing gas flow measurement

Inventors: Jaron M. Acker (Madison, WI); Craig R. Tolmie (Stoughton, WI)
Assignee: Mallinckrodt Pharmaceuticals Ireland Limited
A61M16/125A61M16/0051A61M16/0069A61M16/024A61M2016/0033A61M2016/0039A61M2016/1025A61M2016/1035A61M16/104A61M2202/0275A61M2205/3334A61M2205/52A61M2230/435A61M2230/437
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Quick Facts
Patent No.
US 12,478,757
App. No.
17/685,072
Granted
Nov 25, 2025
Kind
B2
Abstract

The present disclosure generally relates to systems and methods for delivery of therapeutic gas to patients, using techniques to compensate for disruptions in breathing gas flow measurement, such as when breathing gas flow measurement is unavailable or unreliable. Such techniques include using historical breathing gas flow rate data, such as moving average flow rates, moving median flow rates and/or flow waveforms. At least some of these techniques can be used to ensure that interruption in therapeutic gas delivery is minimized or eliminated.

Claims (34)

1 . A nitric oxide gas delivery apparatus for use with a ventilator, the apparatus comprising:

an injector module operable to be placed in fluid communication with a breathing circuit affiliated with the ventilator, the injector module comprising:

a breathing gas flow inlet;

a nitric oxide (NO) flow inlet; and

a combined breathing gas and NO flow outlet operable to provide a combined flow of breathing gas and NO to a patient, in need thereof;

a breathing gas flow sensor configured to sense breathing gas flow rate;

one or more NO flow sensors operable to measure the flow of NO; and

a controller comprising:

a memory operable to store a record of historical commanded or input controlled flow rates; and

a controller operable to control the breathing gas flow rate based on a first mode, and to detect a disruption of breathing gas flow rate data from the breathing gas flow sensor,

wherein upon detection of the disruption in breathing gas flow rate data, the controller operates in a backup mode to control a delivery flow rate of the NO based on the record of historical commanded or input controlled flow rates.

2 . The apparatus of claim 1 , wherein the controller operating in backup mode controls the delivery flow rate of the NO at the historical commanded or input controlled flow rates.

3 . The apparatus of claim 1 , wherein the historical commanded or input controlled flow rate is referenced to calculate a desired NO flow rate for a new set dose of NO.

4 . The apparatus of claim 1 , wherein the backup mode controls the delivery flow rate of the NO based on the record of historical commanded or input controlled flow rates when historical measured flow rates are unavailable.

5 . The apparatus of claim 1 , further comprising a display, wherein when the controller is operating in the backup mode, the historical commanded or input controlled flow rate is displayed on the display.

6 . The apparatus of claim 1 , further comprising a control valve operable to regulate flow of the NO through a conduit to the injector module.

7 . The apparatus of claim 6 , wherein the one or more NO flow sensors are located upstream from the control valve and/or the conduit, and wherein the one or more NO flow sensors are operable to measure the flow of NO through the NO flow inlet into the injector module.

8 . The apparatus of claim 6 , wherein the one or more NO flow sensors are located downstream from the control valve and/or the conduit, and wherein the one or more NO flow sensors are operable to measure the flow of NO through the NO flow inlet into the injector module.

9 . The apparatus of claim 1 , wherein the controller is operable to automatically return to the first mode upon detection that the disruption has ended and/or that the breathing gas flow sensor has been at least one of reconnected, replaced, and/or serviced.

10 . The apparatus of claim 1 , wherein the controller is configured to automatically resume delivery of a flow of NO based on the first mode, upon detection and/or input that the breathing gas flow sensor has been at least one of reconnected, replaced, and/or serviced.

11 . A method for delivery of nitric oxide (NO) gas to a patient, the method comprising:

controlling, via a controller, a NO flow to a patient in a first mode;

receiving, via a breathing gas sensor, sensed flow rate of breathing gas flow;

receiving, via one or more NO flow sensors, a measured flow rate of NO flow;

storing in a memory a record of historical commanded or input controlled flow rates;

detecting a disruption of the sensed breathing gas flow rate data from the breathing gas sensor; and

controlling, via the controller, the NO flow in a backup mode instead of the first mode, based on the historical commanded or input controlled flow rates.

12 . The method of claim 11 , further comprising displaying the historical commanded or input controlled flow rates on a display when the controller is operating in the backup mode.

13 . The method of claim 11 , wherein when the controller is operating in backup mode, the record of historical commanded or input controlled flow rates controls the flow rate of the NO.

14 . The method of claim 11 , further comprising:

returning to the first mode when a discontinuance of the disruption is detected.

15 . The method of claim 14 , wherein:

receiving the sensed breathing gas flow rate includes receiving a first breathing gas flow rate data and a second breathing gas flow rate data, and

detecting the disruption includes detecting the disruption by comparing respective flow rate data between the first and second breathing gas flow rate data.

Assignments (11)
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 064709, FRAME 0055 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 065609/0860 →
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 064709/FRAME 0111 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; SPECGX LLC; STRATATECH CORPORATION; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0308 →
SECURITY INTEREST Recorded Aug 25, 2023
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT LLC; STRATATECH CORPORATION; OCERA THERAPEUTICS, INC.; SPECGX LLC
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 064709/0055 →
SECURITY INTEREST Recorded Aug 25, 2023
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT LLC; STRATATECH CORPORATION; OCERA THERAPEUTICS, INC.; SPECGX LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 064709/0111 →
SECURITY INTEREST Recorded Aug 25, 2023
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT LLC; STRATATECH CORPORATION; OCERA THERAPEUTICS, INC.; SPECGX LLC
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 064709/0070 →