IP Library Granted Patent US 11,950,590
Granted Patent B2
US 11,950,590 · App. 17/360,916 · Granted Apr 9, 2024

Methods to improve organ viability

Inventor: Jim Potenziano (Hazelwood, MO)
Assignee: Mallinckrodt Pharmaceuticals Ireland Limited
A01N1/021A01N1/0226A01N1/0247A61B17/00A61B2017/00969
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Quick Facts
Patent No.
US 11,950,590
App. No.
17/360,916
Granted
Apr 9, 2024
Kind
B2
Abstract

The present disclosure provides methods to improve the viability of an organ, or organs, by continuously administering a composition comprising NO x gas directly to the organ(s).

Claims (17)

1. A method to improve the viability of an organ intended for transplant or damaged by ischemia-reperfusion, the method comprising:

administering to the organ an initial dose of about 0.05 ppm to about 20 ppm of nitric oxide (NO) gas directly to the organ via an organ perfusion system or ventilation; and

incrementally increasing the dose of NO gas by increments of 0.1 ppm to 5 ppm until the viability of the organ is increased, the dose of NO gas exceeds 50 ppm, or a methemoglobin level exceeds 5%.

2. The method of claim 1 , where in the composition is administered for at least one hour but not more than 12 hours.

3. The method of claim 1 , wherein the composition is administered after the organ has been harvested from a donor.

4. The method of claim 1 , wherein the composition is administered while the organ is within a brain dead donor.

5. The method of claim 1 , wherein the organ is selected from the group consisting of lungs, heart, liver, kidney, pancreas, intestine, thymus, and cornea.

6. A method to improve the viability of an organ intended for transplant or damaged by ischemia-reperfusion, the method comprising:

administering to the organ an initial dose of about 0.05 ppm to about 20 ppm of nitric oxide (NO) gas directly to the organ via an organ perfusion system or ventilation; and

adjusting the dose of NO gas until the viability of the organ is increased, the dose of NO gas exceeds 50 ppm, or a methemoglobin level exceeds 5%.

7. The method of claim 6 , wherein the adjusting comprises incrementally adjusting the dose of NO gas by 5% to 200% relative to the last NO concentration, incrementally adjusting a flow rate of the NO gas, or incrementally increasing the dose of NO gas by increments of 0.1 ppm to 5 ppm.

8. The method of claim 6 , further comprising monitoring a nitric oxide marker selected from methemoglobin, NO, nitrite ions (NO 2 ), and nitrate ions (NO 3 ).

9. The method of claim 6 , further comprising decreasing the dose of NO gas when the dose of NO gas exceeds 50 ppm or the methemoglobin level exceeds 5%.

10. The method of claim 9 , further comprising providing an alarm if the dose of NO gas exceeds 50 ppm or the methemoglobin level exceeds 5%.

11. The method of claim 8 , wherein the NO gas is administered in a perfusion fluid.

12. The method of claim 11 , wherein the NO 2 is monitored in the perfusion fluid.

13. The method of claim 12 , further comprising removing NO 2 through the use of a reducing agent, scrubber, base, or other appropriate means.

Assignments (13)
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 Mar 30, 2025
From: POTENZIANO, JIM
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 070674/0347 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 070674/0362 →
CHANGE OF NAME Recorded Mar 30, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 070674/0403 →
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 →