IP Library Granted Patent US 8,893,717
Granted Patent B2
US 8,893,717 · App. 13/331,807 · Granted Nov 25, 2014

Systems and methods of administering a pharmaceutical gas to a patient

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Quick Facts
Patent No.
US 8,893,717
App. No.
13/331,807
Granted
Nov 25, 2014
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 (37)

1. A method of administering a therapy gas to a patient, the therapy gas being at least one gas selected from CO and NO, the method comprising:

determining a desired total quantity of therapy gas to be administered to the patient over a period of time over a plurality of breaths;

administering a quantity of therapy gas to the patient during inspiration every n th breath of the plurality of breaths, wherein n is 1 or greater; and

varying the quantity of therapy gas per n th breath to ensure that the desired total quantity over the period of time is administered independent of the respiratory pattern of the patient.

2. The method of claim 1 , wherein the quantity of therapy gas per n th breath is in the range of a minimum quantity of therapy gas per breath and a maximum quantity of therapy gas per breath.

3. The method of claim 2 , wherein the quantity of therapy gas per n th breath is a function of one or more of a first respiratory rate, a first tidal volume of the patient and the patient's ideal body weight.

4. The method of claim 3 , wherein when the quantity of therapy gas per n th breath to be delivered is greater than the minimum quantity of therapy gas per breath and less than the maximum quantity of therapy gas per breath, the quantity of therapy gas per breath is administered on the n th breath, or when the quantity of therapy gas per n th breath is less than the minimum quantity of therapy gas per breath, administration of the quantity of therapy gas per n th breath is skipped for that n th breath, or when the quantity of therapy gas per n th breath is greater than the maximum quantity of therapy gas per breath, one or more of an alarm is triggered or the maximum quantity is delivered on the nth breath and a difference between the quantity of therapy gas per n th breath to be delivered and the maximum quantity of therapy gas per breath is carried to one or more subsequent breaths.

5. The method of claim 4 , wherein when the quantity of therapy gas per n th breath is skipped, a new quantity of therapy gas per n th breath is calculated.

6. The method of claim 4 , wherein when the quantity of therapy gas per n th breath is greater than the maximum quantity of therapy gas per breath, the maximum quantity of therapy gas per breath is administered on the n th breath and the difference between the quantity of therapy gas per n th breath and the maximum quantity of therapy gas per breath is added to one or more subsequent breaths.

7. The method of claim 1 , wherein n is 2 or greater and the therapy gas is delivered during the n th breath.

8. The method of claim 7 , wherein no therapy gas is administered during the breaths that are not n th breaths.

9. The method of claim 7 , wherein the quantity of therapy gas per n th breath is in the range of a minimum quantity of therapy gas per breath and a maximum quantity of therapy gas per breath.

10. The method of claim 9 , wherein the quantity of therapy gas per n th breath is a function of one or more of a first respiratory rate, a first tidal volume of the patient and the patient's ideal body weight.

11. The method of claim 10 , wherein when the quantity of therapy gas per n th breath to be delivered is greater than the minimum quantity of therapy gas per breath and less than the maximum quantity of therapy gas per breath, the quantity of therapy gas per n th breath is administered on the n th breath, or when the quantity of therapy gas per n th breath is less than the minimum quantity of therapy gas per breath, administration of the quantity of therapy gas per n th breath is skipped for that n th breath, or when the quantity of therapy gas per n th breath is greater than the maximum quantity of therapy gas per breath, one or more of an alarm is triggered or the maximum quantity is delivered on the n th breath and a difference between the quantity of therapy gas per n th breath to be delivered and the maximum quantity of therapy gas per breath is carried to one or more subsequent breaths.

12. The method of claim 11 , wherein when the quantity of therapy gas per n th breath is skipped, a new quantity of therapy gas per n th breath is calculated.

13. The method of claim 12 , further comprising repeating the administration of the therapy gas on one or more subsequent breaths.

14. The method of claim 11 , wherein when the quantity of therapy gas per n th breath is greater than the maximum quantity of therapy gas per breath, the maximum quantity of therapy gas per breath is administered on the n th breath and the difference between the quantity of therapy gas per n th breath and the maximum quantity of therapy gas per breath is added to one or more subsequent breaths.

15. The method of claim 14 , further comprising repeating the administration of the therapy gas on one or more subsequent breaths.

16. The method of claim 11 , wherein when the quantity of therapy gas per n th breath is greater than the maximum quantity of therapy gas per breath, the maximum quantity of therapy gas per breath is administered on the n th breath and the difference between the quantity of therapy gas per n th breath and the maximum quantity of therapy gas per breath is administered over one or more subsequent breaths that are not an n th breath.

17. The method of claim 1 , wherein the therapy gas is delivered to the patient's alveoli.

18. The method of claim 1 , wherein the therapy gas is delivered to the patient during the first half of the inspiratory cycle.

19. A method of administering a therapy gas to a patient, the therapy gas being at least one of CO and NO, the method comprising:

a) determining a desired total quantity of therapy gas to be administered to the patient over a period of time over a plurality of breaths;

b) calculating a quantity of therapy gas to be administered to the patient every n th breath, calculating the quantity based on one or more of respiratory rate and quantity already given to the patient;

c) administering the quantity of therapy gas to the patient's alveoli during the first half of the inspiratory cycle for every n th breath of the plurality of breaths, n being greater than 1 averaged over the period of time; and

d) repeating steps b) and c) varying the quantity of therapy gas per n th breath to ensure that the desired total quantity over the period of time is maintained independent of the respiratory pattern of the patient.

20. The method of claim 19 , further comprising comparing the quantity of therapy gas to be delivered to determine if the quantity is in the range of a minimum quantity and a maximum quantity.

21. The method of claim 20 , wherein, if the quantity of therapy gas to be delivered is lower than the minimum quantity, then the quantity of therapy gas delivered during the breath is zero and the quantity of therapy gas to be delivered is added to one or more subsequent breaths.

22. The method of claim 20 , wherein if the quantity of therapy gas to be delivered is greater than the maximum quantity, then performing one or more of activating an alarm, determining the difference between the quantity of therapy gas to be delivered and the maximum quantity, administering the maximum quantity or adding the difference between the quantity of therapy gas to be delivered and the maximum quantity to one or more subsequent breaths.

23. A system for administering a therapy gas to a patient having a respiratory pattern, the therapy gas being at least one gas selected from CO and NO, the system comprising:

an inlet to connect to a source of the therapy gas;

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

a setting control to determine a desired total quantity of therapy gas to be administered to the patient over a period of time over a plurality of breaths;

and a gas control system to administer the desired total quantity of therapy gas to the patient during inspiration by the patient over the period of time is independent of the respiratory pattern of the patient, wherein the gas control system is configured to

a) calculate a quantity of therapy gas to be administered to the patient every n th breath, calculating the quantity based on one or more of respiratory rate and quantity already given to the patient,

b) administer the quantity of therapy gas to the patient's alveoli during the first half of the inspiratory cycle for every n th breath of the plurality of breaths, n being greater than 1 averaged over the period of time, and

c) repeat steps a) and b) varying the quantity of therapy gas per breath to ensure that the desired total quantity over the period of time is maintained independent of the respiratory pattern of the patient.

Assignments (32)
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 →
CHANGE OF NAME Recorded Aug 16, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 072477/0834 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 16, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 072040/0424 →
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 035454, FRAME 0768 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
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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 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 →
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 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 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: MALLINCKRODT CRITICAL CARE FINANCE INC.
To: MALLINCKRODT PHARMA IP TRADING DAC
Reel/Frame 038038/0009 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: MALLINCKRODT PHARMA IP TRADING DAC
To: MALLINCKRODT IP
Reel/Frame 038009/0058 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: MALLINCKRODT IP
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 038009/0016 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: INO THERAPEUTICS LLC
To: THERAKOS, INC.
Reel/Frame 038008/0956 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: THERAKOS, INC.
To: MALLINCKRODT CRITICAL CARE FINANCE INC.
Reel/Frame 038008/0824 →
SECURITY INTEREST Recorded Apr 19, 2015
From: INO THERAPEUTICS LLC
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 035454/0768 →
RELEASE OF SECURITY INTEREST Recorded Apr 17, 2015
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH
To: INO THERAPEUTICS LLC
Reel/Frame 035453/0513 →
RELEASE OF SECURITY INTEREST Recorded Apr 17, 2015
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH
To: INO THERAPEUTICS LLC
Reel/Frame 035453/0487 →
PATENT SECURITY AGREEMENT (FIRST LIEN) Recorded Mar 11, 2014
From: INO THERAPEUTICS LLC
To: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS ADMINISTRATIVE AGENT
Reel/Frame 032426/0747 →
PATENT SECURITY AGREEMENT (SECOND LIEN) Recorded Mar 11, 2014
From: INO THERAPEUTICS LLC
To: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS ADMINISTRATIVE AGENT
Reel/Frame 032426/0848 →
RELEASE OF SECURITY INTEREST Recorded Feb 18, 2014
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS COLLATERAL AGENT
To: INO THERAPEUTICS LLC
Reel/Frame 032274/0768 →
RELEASE OF SECURITY INTEREST Recorded Feb 14, 2014
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS COLLATERAL AGENT
To: IKARIA INC.; INO THERAPEUTICS LLC
Reel/Frame 032264/0517 →
SECURITY AGREEMENT Recorded Jul 10, 2013
From: IKARIA, INC.; IKARIA ACQUISITION INC.; INO THERAPEUTICS LLC
To: CREDIT SUISSE AG, AS COLLATERAL AGENT
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SECURITY AGREEMENT Recorded Jul 9, 2013
From: IKARIA, INC.; IKARIA ACQUISITION INC.; INO THERAPEUTICS LLC
To: CREDIT SUISSE AG, AS COLLATERAL AGENT
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ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 3, 2012
From: MONTGOMERY, FREDERICK J.; BATHE, DUNCAN P.L.
To: INO THERAPEUTICS LLC
Reel/Frame 028065/0780 →