IP Library Granted Patent US 11,412,731
Granted Patent B2
US 11,412,731 · App. 16/856,632 · Granted Aug 16, 2022

Administration and monitoring of nitric oxide in ex vivo fluids

Inventors: Jim Potenziano (Binghamton, NY); Douglas R. Hansell (Easton, PA); Jeff Griebel (Arora, CO); Eddie Costa (San Diego, CA); Lisa Cooper (Upper Black Eddy, PA); David William Newman (Lebanon, NJ)
Assignee: Mallinckrodt Pharmaceuticals Ireland Limited
A01N1/0247A01N1/0226A61M1/1698A61M2016/1035A61M2202/0275A61M2230/30A61M2230/437
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Quick Facts
Patent No.
US 11,412,731
App. No.
16/856,632
Granted
Aug 16, 2022
Kind
B2
Abstract

Described are systems and methods for monitoring administration of nitric oxide (NO) to ex vivo fluids. Examples of such fluids include blood in extracorporeal membrane oxygenation (ECMO) circuits or perfusion fluids used for preserving ex vivo organs prior to transplanting in a recipient. The systems and methods described herein provide for administering nitric oxide to the fluid, monitoring nitric oxide or a nitric oxide marker in the fluid, and adjusting the nitric oxide administration.

Claims (21)

1. A system for delivering and monitoring nitric oxide (NO) to an ex vivo lung, comprising:

a container operable for storing the lung and filled with a perfusion fluid for perfusing the lung;

a NO delivery device operable to administer NO to the perfusion fluid; and

a monitoring device operable to monitor methemoglobin in the perfusion fluid,

wherein the monitoring device is in communication with the NO delivery device, and the NO delivery device is operable to adjust the NO administration based on the monitoring of the methemoglobin.

2. The system of claim 1 , wherein the monitoring device is a separate component from the NO delivery device.

3. The system of claim 1 , wherein the monitoring device is integrated with the NO delivery device.

4. The system of claim 3 , wherein the monitoring device is further operable to monitor at least one additional parameter of the perfusion fluid selected from at least one of NO, a NO marker, and an indicator of tissue damage.

5. The system of claim 1 , wherein the perfusion fluid includes NO or an NO donor.

6. The system of claim 5 , wherein the monitoring device is further operable to monitor at least one additional parameter of the perfusion fluid including at least one of NO, a NO marker and an indicator of tissue damage.

7. The system of claim 6 , wherein the NO delivery device is further operable to adjust the amount of NO or NO donor provided to the lung according to the methemoglobin and the additional parameter monitored.

8. The system of claim 5 , wherein the monitoring device is further operable to monitoring at least one secondary parameter including at least one of pulmonary vascular resistance (PVR), pulmonary capillary wedge pressure (PCWP) and mean pulmonary arterial pressure (mPAP).

9. The system of claim 8 , wherein the NO delivery device is further operable to adjust the amount of NO or NO donor provided to the lung according to the monitored secondary parameter.

10. The system of claim 1 , further comprising a catheter operable to be connected to the lung, the catheter operable to inject a persufflation gas into the lung.

11. The system of claim 10 wherein the system is operable to perfuse and persufflate the lung simultaneously.

12. The system of claim 10 , wherein the perfusion fluid has a first composition and the container is filled with a preservation fluid having a second composition used to store the lung during persufflation.

13. The system of claim 1 , further comprising a ventilator operable to ventilate the lung.

14. The system of claim 13 , wherein the system is operable to perfuse and ventilate the lung simultaneously.

15. The system of claim 1 , wherein the perfusion fluid includes red blood cells.

16. The system of claim 1 , wherein the perfusion fluid includes at least one of a histidine-tryptophan-ketoglutarate solution and a colloid-containing, extracellular-type low K+ electrolyte solution.

17. The system of claim 1 , wherein the monitoring device is operable to monitor methemoglobin in the perfusion fluid continuously.

Assignments (10)
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 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 →
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 →