IP Library Granted Patent US 10,960,169
Granted Patent B2
US 10,960,169 · App. 16/156,453 · Granted Mar 30, 2021

System and method of administering a pharmaceutical gas to a patient

Inventors: Frederick J. Montgomery (Sun Prairie, WI); Duncan P. Bathe (Fitchburg, WI)
Assignee: Mallinckrodt Hospital Products IP Limited
A61M16/12A61M16/0003A61M16/0051A61M16/024A61M16/04A61M16/0666A61M16/105A61M16/201A61M16/107A61M2016/003A61M2016/0015A61M2016/0021A61M2016/0027A61M2016/0039A61M2202/0233A61M2202/0275A61M2205/18A61M2205/3334A61M2205/50A61M2205/75
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Quick Facts
Patent No.
US 10,960,169
App. No.
16/156,453
Granted
Mar 30, 2021
Kind
B2
Abstract

Methods and systems for delivering a pharmaceutical gas to a patient. The methods and systems provide a known desired quantity of the pharmaceutical gas to the patient independent of the respiratory pattern of the patient over a plurality of breaths every n th breath, where n is greater than or equal to 1. The pharmaceutical gases include CO and NO, both of which are provided as a concentration in a carrier gas. The gas control system determines the delivery of the pharmaceutical gas to the patient to result in the known desired quantity (e.g. in molecules, milligrams or other quantified units) of the pharmaceutical gas being delivered. Upon completion of that known desired quantity of pharmaceutical gas over a plurality of breaths, the system can either terminate, continue, activate and alarm, etc.

Claims (27)

1. A method of administering a pharmaceutical gas to a patient, wherein the pharmaceutical gas comprises at least one of nitric oxide or carbon monoxide, the method comprising:

delivering a first quantity of the pharmaceutical gas to the patient in a first breath;

monitoring the patient's respiratory rate or changes in the patient's respiratory rate;

varying the quantity of pharmaceutical gas delivered to the patient in one or more subsequent breaths based on the monitored respiratory rate or changes in the patient's respiratory rate.

2. The method of claim 1 , wherein the quantity delivered in the subsequent breath is greater than the first quantity in response to a decrease in the patient's respiratory rate.

3. The method of claim 1 , wherein the quantity delivered in the subsequent breath is less than the first quantity in response to an increase in the patient's respiratory rate.

4. The method of claim 1 , wherein varying the quantity of pharmaceutical gas delivered to the patient avoids high unsafe doses or doses too low to be effective.

5. The method of claim 1 , wherein the pharmaceutical gas is delivered to the patient every breath.

6. The method of claim 1 , wherein the pharmaceutical gas is delivered to the patient every nth breath, wherein n is 1 or greater.

7. The method of claim 1 , wherein at least one breath is skipped such that pharmaceutical gas is not administered during the breath.

8. The method of claim 7 , wherein when the breath is skipped, a new quantity of pharmaceutical gas per nth breath is calculated.

9. The method of claim 1 , wherein when the quantity of pharmaceutical gas to be delivered in a breath is greater than a maximum quantity of pharmaceutical gas per breath, the maximum quantity of pharmaceutical gas per breath is administered and the difference between the quantity of pharmaceutical gas to be delivered in the breath and the maximum quantity of pharmaceutical gas per breath is added to one or more subsequent breaths.

10. The method of claim 1 , wherein one or more of the first quantity and the quantity delivered in the subsequent breath is delivered during the first half of inspiration.

11. A gas delivery system comprising:

an inlet to connect to a source of pharmaceutical gas comprising at least one of nitric oxide or carbon monoxide;

an outlet to connect to a device that introduces the pharmaceutical gas to a patient;

a breath trigger sensor to measure a patient's respiratory rate; and

a gas control system in communication with the breath trigger sensor that delivers a varying quantity of pharmaceutical gas to the patient based on changes in the patient's respiratory rate.

12. The system of claim 11 , wherein a quantity delivered in a subsequent breath is greater than a quantity delivered in a previous breath in response to a decrease in the patient's respiratory rate.

13. The system of claim 11 , wherein a quantity delivered in a subsequent breath is less than a quantity delivered in a previous breath in response to an increase in the patient's respiratory rate.

14. The system of claim 11 , wherein the gas control system delivers the quantity of pharmaceutical gas during the first half of the patient's inspiratory cycle.

15. The system of claim 11 , wherein the gas control system delivers the pharmaceutical gas to the patient every breath.

16. The system of claim 11 , wherein delivering a varying quantity of pharmaceutical gas to the patient avoids high unsafe doses or doses too low to be effective.

17. The system of claim 11 , wherein the pharmaceutical gas is delivered to the patient every nth breath, wherein n is 1 or greater.

18. The system of claim 11 , wherein at least one breath is skipped such that pharmaceutical gas is not administered during the breath.

19. The system of claim 18 , wherein when the breath is skipped, a new quantity of pharmaceutical gas per nth breath is calculated.

20. The system of claim 11 , wherein when a quantity of pharmaceutical gas to be delivered in a breath is greater than a maximum quantity of pharmaceutical gas per breath, the maximum quantity of pharmaceutical gas per breath is administered and the difference between the quantity of pharmaceutical gas to be delivered in the breath and the maximum quantity of pharmaceutical gas per breath is added to one or more subsequent breaths.

Assignments (15)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2026
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED COMPANY
Reel/Frame 075393/0608 →
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 →
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 →
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: SPECGX LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS 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 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 049822, FRAME 0674 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 065609/0454 →
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 →
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 Jul 22, 2019
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 049822/0674 →
Continuity (7)
Continuation 14551186 · Nov 24, 2014
Continuation 13331807 · Dec 20, 2011
Continuation In Part 12430220 · Apr 27, 2009
Continuation In Part 13287663 · Nov 2, 2011
Continuation 13284433 · Oct 28, 2011
Continuation 11231554 · Sep 21, 2008
Related Publication 20190038864A1 · Feb 7, 2019