IP Library Granted Patent US 11,554,242
Granted Patent B2
US 11,554,242 · App. 16/502,828 · Granted Jan 17, 2023

Systems and methods for manufacturing and safety of an NO

Inventors: Jaron M. Acker (Madison, WI); Thomas Kohlmann (McFarland, WI)
Assignee: Mallinckrodt Pharmaceuticals Ireland Limited
A61M16/122A61M16/0003A61M16/0051A61M16/0875A61M16/20B01J8/02G01F1/34A61M2016/003A61M2202/0275A61M2205/18A61M2205/3334A61M2205/35A61M2205/50B01J2208/00893B01J2208/02
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Quick Facts
Patent No.
US 11,554,242
App. No.
16/502,828
Granted
Jan 17, 2023
Kind
B2
Abstract

The principles and embodiments of the present invention relate to methods and systems for safely providing NO to a recipient for inhalation therapy. There are many potential safety issues that may arise from using a reactor cartridge that converts NO 2 to NO, including exhaustion of consumable reactants of the cartridge reactor. Accordingly, various embodiments of the present invention provide systems and methods of determining the remaining useful life of a NO 2 -to-NO reactor cartridge and/or a breakthrough of NO 2 , and providing an indication of the remaining useful life and/or breakthrough.

Claims (13)

1. A reactor cartridge for converting NO 2 to NO for delivery to a patient using a gas delivery system, comprising:

an outer reactor shell;

an inlet end wall that seals the inlet end of the reactor;

an outlet end wall that seals the outlet end of the reactor to form an internal volume within the reactor cartridge;

an inlet that facilitates connection of the reactor cartridge to a first gas conduit and allows passage of gas through the inlet end wall to the internal volume;

an outlet that facilitates connection of the reactor cartridge to a second gas conduit and allows passage of gas through the outlet end wall to exit the reactor cartridge;

a consumable conversion media retained within the internal volume of the reactor cartridge that facilitates conversion of an incoming NO 2 gas delivered to the inlet to an outgoing NO gas exiting at the outlet for delivery to the patient;

a back end retainer positioned towards the outlet of the reactor cartridge to prevent consumable conversion media from exiting the internal volume of the reactor cartridge through the outlet;

a front end retainer positioned towards the inlet of the reactor cartridge to prevent consumable conversion media from exiting the internal volume of the reactor cartridge through the inlet, wherein the consumable conversion media is retained between the front end retainer and the back end retainer;

a force-applying member positioned between the inlet end wall and the front end retainer to apply a pressure to the consumable conversion media; and

a memory chip affixed to the outer reactor shell, wherein the memory chip stores data relating to the conversion cartridge that the chip is affixed to on a non-transient computer readable medium, wherein the stored data comprises identification data, testing data, and cartridge life data, wherein the memory chip is configured to be in electronic communication with a computer and wherein the computer is configured to read the stored data and prevent the gas delivery system from entering an operational state if the identification data, testing data, or cartridge life data exceeds a stored average expected identification data, testing data, or cartridge life data, wherein the identification data includes a cartridge serial number, a lot and/or batch number, a production date, and/or an expiration date, the testing data includes a weight of consumable conversion media within the conversion cartridge, values of test results showing conversion efficiency of NO 2 to NO, pressure drop across the consumable conversion media, and/or a humidity level of the consumable conversion media, and the cartridge life data includes average expected cartridge life calculated from the testing data, total expected NO 2 conversion by weight, concentration, and/or volume, and/or expected duration of usage at an average gas flow rate.

2. The reactor cartridge of claim 1 , which further comprises an impact sensor affixed to and/or operatively associated with the reactor cartridge, wherein the impact sensor is configured to determine the number of impacts and/or the severity of the impact(s) experienced by the reactor cartridge.

3. The reactor cartridge of claim 1 , which further comprises an inlet with a keyed or polarized cartridge connector and/or an outlet with a keyed or polarized cartridge connector, wherein the keyed or polarized inlet and/or outlet connectors interact with a mechanical interlock to ensure the reactor cartridge is installed with the correct orientation in a gas delivery system.

Assignments (24)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2023
From: MALLINCKRODT IP
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 065933/0857 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2023
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065934/0292 →
CHANGE OF NAME Recorded Dec 21, 2023
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 066094/0405 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2023
From: ACKER, JARON M.; KOHLMANN, THOMAS
To: INO THERAPEUTICS LLC
Reel/Frame 065932/0740 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2023
From: INO THERAPEUTICS LLC
To: THERAKOS, INC.
Reel/Frame 065932/0847 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2023
From: THERAKOS, INC.
To: MALLINCKRODT CRITICAL CARE FINANCE INC.
Reel/Frame 065932/0988 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2023
From: MALLINCKRODT CRITICAL CARE FINANCE INC.
To: MALLINCKRODT PHARMA IP TRADING DAC
Reel/Frame 065933/0145 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2023
From: MALLINCKRODT PHARMA IP TRADING DAC
To: MALLINCKRODT IP
Reel/Frame 065933/0599 →
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 →
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 →
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 →
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 →
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 →