IP Library Granted Patent US 8,616,204
Granted Patent B2
US 8,616,204 · App. 13/942,136 · Granted Dec 31, 2013

System and method of administering a pharmaceutical gas to a patient

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Quick Facts
Patent No.
US 8,616,204
App. No.
13/942,136
Granted
Dec 31, 2013
Kind
B2
Abstract

A method and system for delivering a pharmaceutical gas to a patient. The method and system provide a known desired quantity of the pharmaceutical gas to the patient independent of the respiratory pattern of the patient. The preferred pharmaceutical gases are 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 any further delivery of the pharmaceutical gas or can activate an alarm to alert the user that the known quantity has been delivered. The system also has alarm functions to alert the user of possible malfunctions of the system.

Claims (37)

1. A pharmaceutical gas delivery system, comprising:

an inlet to connect to at least one gas source;

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

a first flow valve and a first flow orifice in fluid communication with the inlet and the outlet, wherein the first flow valve and the first flow orifice deliver at a first fixed flow rate;

a second flow valve and a second flow orifice in fluid communication with the inlet and the outlet, wherein the second flow valve and the second flow orifice deliver at a second fixed flow rate that is higher than the first fixed flow rate; and

a delivery control system that delivers the pharmaceutical gas over a plurality of breaths by opening one or more of the first flow valve and the second flow valve, wherein the delivery control system delivers the pharmaceutical gas during at least part of the first half of the patient's inspiratory cycle.

2. The system of claim 1 , wherein one or more of the first fixed flow rate is about 1 L/min and the second fixed flow rate is about 6 L/min.

3. The system of claim 1 , wherein the device that introduces the pharmaceutical gas to the patient is one or more of (1) in fluid communication with a ventilator and (2) comprising one or more of a nasal cannula, an endotracheal tube, and a face mask.

4. The system of claim 1 , wherein one or more of (1) the pharmaceutical gas that is delivered to the patient comprises nitric oxide and (2) the at least one gas source comprises nitric oxide in a known concentration in a carrier gas.

5. The system of claim 4 , wherein the delivery control system controls the volume of pharmaceutical gas delivered during the patient's breath based upon the concentration of the nitric oxide in the carrier gas.

6. The system of claim 1 , further comprising a patient trigger sensor that senses the beginning of a patient's inspiratory cycle.

7. The system of claim 1 , wherein the first flow valve and the second flow valve are arranged in parallel.

8. The system of claim 1 , wherein the first flow valve and the second flow valve are not open at the same time.

9. The system of claim 1 , wherein the pharmaceutical gas delivered opening the first flow valve and the pharmaceutical gas delivered opening the second flow valve are delivered to the patient in different breaths.

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

11. The system of claim 1 , wherein one or more of the first flow valve and the second flow valve open providing at least one of a range of doses, a desired flow rate, a desired volume, and a desired dose.

12. The system of claim 1 , wherein the delivery control system at least one of determines or allows setting of one or more of (1) a desired quantity of the pharmaceutical gas to be delivered to the patient over the plurality of breaths, (2) an amount of the pharmaceutical gas per breath to be delivered to the patient, (3) a duration of time to deliver the pharmaceutical gas to the patient, and (4) a number of breaths to deliver the pharmaceutical gas to the patient.

13. The system of claim 1 , wherein the pharmaceutical gas is delivered for one or more of (1) a duration of time and (2) a number of breaths.

14. The system of claim 1 , wherein an amount of the pharmaceutical gas delivered in at least one breath varies from an amount of the pharmaceutical gas delivered in at least one other breath in the plurality of breaths.

15. The system of claim 14 , wherein the amount of the pharmaceutical gas varies in response to the patient's respiratory rate.

16. A method of administering a pharmaceutical gas to a patient, the method comprising:

providing a gas delivery system having a first flow valve and a first flow orifice and a second flow valve and a second flow orifice, wherein opening the first flow valve delivers the pharmaceutical gas at a first fixed flow rate and opening the second flow valve delivers the pharmaceutical gas at a second fixed flow rate higher than the first flow rate;

delivering the pharmaceutical gas over a plurality of breaths to the patient during inspiration by opening one or more of the first flow valve and the second flow valve, wherein the pharmaceutical gas is delivered during at least part of the first half of the patient's inspiratory cycle.

17. The method of claim 16 , wherein one or more of the first fixed flow rate is about 1 L/min and the second fixed flow rate is about 6 L/min.

18. The method of claim 16 , wherein the device that introduces the pharmaceutical gas to the patient is one or more of (1) in fluid communication with a ventilator and (2) comprising one or more of a nasal cannula, an endotracheal tube, and a face mask.

19. The method of claim 16 , wherein one or more of (1) the pharmaceutical gas that is delivered to the patient comprises nitric oxide and (2) the at least one gas source comprises nitric oxide in a known concentration in a carrier gas.

20. The method of claim 19 , wherein the volume of pharmaceutical gas delivered during the patient's breath is based upon the concentration of the nitric oxide in the carrier gas.

21. The method of claim 16 , wherein the first flow valve and the second flow valve are in fluid communication with a gas source comprising nitric oxide in a carrier gas.

22. The method of claim 16 , wherein the first flow valve and the second flow valve are arranged in parallel.

23. The method of claim 16 , wherein the first flow valve and the second flow valve are not open at the same time.

24. The method of claim 16 , wherein the pharmaceutical gas delivered opening the first flow valve and the pharmaceutical gas delivered opening the second flow valve are delivered to the patient in different breaths.

25. The method of claim 16 , wherein the pharmaceutical gas is delivered to the patient every breath.

26. The method of claim 16 , wherein one or more of the first flow valve and the second flow valve open providing at least one of a range of doses, a desired flow rate, a desired volume, and a desired dose.

27. The method of claim 16 , further comprising at least one of setting or determining one or more of (1) a desired quantity of the pharmaceutical gas to be delivered to the patient over the plurality of breaths, (2) an amount of the pharmaceutical gas per breath to be delivered to the patient, (3) a duration of time to deliver the pharmaceutical gas to the patient, and (4) a number of breaths to deliver the pharmaceutical gas to the patient.

28. The method of claim 16 , wherein the pharmaceutical gas is delivered for one or more of (1) a duration of time and (2) a number of breaths.

29. The method of claim 16 , wherein an amount of the pharmaceutical gas delivered in at least one breath varies from an amount of the pharmaceutical gas delivered in at least one other breath in the plurality of breaths.

30. The method of claim 29 , wherein the amount of the pharmaceutical gas varies in response to the patient's respiratory rate.

Assignments (13)
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 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 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
Reel/Frame 065610/0035 →
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 →