IP Library Granted Patent US 12,257,391
Granted Patent B2
US 12,257,391 · App. 18/084,113 · Granted Mar 25, 2025

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 12,257,391
App. No.
18/084,113
Granted
Mar 25, 2025
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 (28)

1. A method of testing reactor cartridges to determine an expected lifetime, comprising:

assembling a number of reactor cartridges, comprising;

providing a plurality of conversion cartridge shells;

placing a first retainer on a support within the shell to partition off a section of the internal space;

introducing a volume of a consumable conversion media into at least a portion of the internal volume of the conversion cartridge;

placing a second retainer within the shell, that is held in position against the volume of consumable conversion media by a force-applying member;

closing an inlet end of the conversion cartridge shell with an inlet end wall,

wherein an end of the force-applying member is in contact with the inlet end wall and an opposite end of the force-applying member is in contact with the second retainer, so that a force is applied to the volume of a consumable conversion media; and

closing an outlet end of the conversion cartridge shell with an outlet end wall;

randomly selecting a number of reactor cartridges from the plurality of assembled reactor cartridges, where the number of cartridges selected for testing is less than the number of cartridges assembled;

installing a randomly selected reactor cartridge into a NO gas delivery system;

testing the installed reactor cartridge by a process comprising:

flowing a gas containing a predetermined concentration of NO 2 through the installed reactor cartridge;

measuring the amount of NO 2 -containing gas fed into the reactor cartridge with a flow meter;

detecting the presence of NO 2 at the outlet of the reactor cartridge; and

calculating the amount of NO 2 converted to NO by the reactor cartridge up to the time NO 2 was detected at the outlet of the of the reactor cartridge with a computer; and

replacing the installed reactor cartridge with a subsequent randomly selected cartridge and repeating the testing process until all randomly selected reactor cartridges have been tested.

2. The method of testing reactor cartridges of claim 1 , which further comprises:

calculating the amount of consumable conversion media used up to convert the amount of NO 2 converted to NO;

averaging the calculated amount of consumable conversion media used up for each tested reactor cartridge;

calculating the average amount of NO 2 that would be converted to NO for the untested plurality of assembled conversion cartridges.

3. The method of testing reactor cartridges of claim 1 , which further comprises:

affixing a memory chip comprising a non-transient computer readable medium, and configured to communicate with a computer, to each of the conversion cartridge shells; and

storing the average amount of NO 2 that would be converted to NO on the non-transient computer readable medium.

4. The method of testing reactor cartridges of claim 1 , which further comprises:

measuring the amount of H 2 O present in the consumable conversion media with a H 2 O sensor, and comparing the measured amount of H 2 O against a predetermined acceptable range for the reactor cartridge.

5. The method of testing reactor cartridges of claim 1 , which further comprises:

measuring the differential gas pressure across the consumable conversion media to determine if there is a low pressure differential due to channeling or a crack in the conversion media.

Assignments (25)
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 Feb 21, 2025
From: MALLINCKRODT CRITICAL CARE FINANCE INC.
To: MALLINCKRODT PHARMA IP TRADING DAC
Reel/Frame 070296/0726 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2025
From: MALLINCKRODT PHARMA IP TRADING DAC
To: MALLINCKRODT IP
Reel/Frame 070296/0850 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2025
From: INO THERAPEUTICS LLC
To: THERAKOS, INC.
Reel/Frame 070296/0639 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 070297/0014 →
CHANGE OF NAME Recorded Feb 21, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 070721/0536 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2025
From: MALLINCKRODT IP
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 070296/0903 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2025
From: ACKER, JARON M.; KOHLMANN, THOMAS
To: INO THERAPEUTICS LLC
Reel/Frame 070296/0058 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2025
From: THERAKOS, INC.
To: MALLINCKRODT CRITICAL CARE FINANCE INC.
Reel/Frame 070296/0658 →
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: ACKER, JARON M.; KOHLMANN, THOMAS
To: INO THERAPEUTICS LLC
Reel/Frame 065932/0740 →
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 →
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 →
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: INO THERAPEUTICS LLC; 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
Reel/Frame 065609/0860 →
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 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 →
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: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 064709/0070 →
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 →