IP Library Granted Patent US 10,773,046
Granted Patent B2
US 10,773,046 · App. 15/683,290 · Granted Sep 15, 2020

Apparatus and method for monitoring nitric oxide delivery

Inventors: Robert Schnitman (Colchester, CT); Joseph J. Medicis (Syracuse, NY); Jim Potenziano (Binghamton, NY); Jaron Acker (Madison, WI); Jeffrey Schmidt (Oregon, WI)
Assignee: Mallinckrodt Hospital Products IP Limited
A61M16/104A61M16/0051A61M16/024A61M16/12A61M16/0666A61M16/085A61M2016/0039A61M2016/102A61M2202/0275A61M2205/18A61M2205/3334A61M2205/502A61M2205/581A61M2205/583F04C2270/041
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Quick Facts
Patent No.
US 10,773,046
App. No.
15/683,290
Granted
Sep 15, 2020
Kind
B2
Abstract

Described is an apparatus for monitoring nitric oxide delivery, wherein such apparatus comprises an indicator to inform a user of the apparatus when the flow of breathing gas rises above or falls below a predetermined level or range. Also described is a method of monitoring nitric oxide delivery, wherein the flow of breathing gas is measured and displayed. In some embodiments, an alert is provided when the flow of breathing gas rises above or falls below a predetermined level or range.

Claims (31)

1. An apparatus to deliver therapeutic gas to a patient, the apparatus comprising:

a therapeutic gas supply comprising nitric oxide;

a therapeutic gas injector module comprising a first inlet in fluid communication with the therapeutic gas supply, a second inlet in fluid communication with a breathing gas delivery system that provides a breathing gas, and an outlet in fluid communication with the first inlet and the second inlet to supply a mixture of the breathing gas and the therapeutic gas to the patient, the therapeutic gas injector module in communication with the therapeutic gas supply to control the flow of therapeutic gas to the patient and achieve a desired dose of therapeutic gas administered to the patient;

a flow sensor operable to measure the flow of the breathing gas;

a display in communication with the therapeutic gas injector module; and

a control circuit in communication with the therapeutic gas injector module and the display, the control circuit operable to calculate a delivery concentration of the therapeutic gas and operable to send data to the display to produce an indicator to inform the user of the apparatus when the calculated delivery concentration is in one of a target delivery region, an under-delivery of nitric oxide region, and an over-delivery of nitric oxide region.

2. The apparatus of claim 1 , wherein the control circuit includes a CPU and a flow controller.

3. The apparatus of claim 2 , wherein the CPU sends and receives signals to the flow sensor and the flow controller such that the control circuit maintains a minimum flow of therapeutic gas to the patient.

4. The apparatus of claim 3 , wherein the control circuit further comprises clinical decision support software.

5. The apparatus of claim 4 , wherein the clinical decision support software comprises instructions to reset any upper and lower limits of maximum and minimum dose to avert shutdown of the apparatus.

6. The apparatus of claim 2 , wherein the flow of the breathing gas is detected by the flow sensor and the flow of therapeutic gas delivered to the therapeutic gas injector module is controlled by the CPU and flow controller to a achieve the desired dose of the therapeutic gas to the patient based on the detected flow rate of the breathing gas and the concentration of nitric oxide in the therapeutic gas supply.

7. The apparatus of claim 1 , wherein the indicator provides an alert when the flow of breathing gas rises above or falls below a predetermined level.

8. The apparatus of claim 7 , wherein the alert includes one or more of an audible alert, a visual alert and a text alert.

9. The apparatus of claim 7 , wherein the predetermined level is the level at which the apparatus shuts down.

10. The apparatus of claim 1 , wherein the display provides a visual and/or numeric indication of the volumetric flow of breathing gas.

11. The apparatus of claim 10 , wherein the visual and/or numeric indication includes one or more of volumetric flow rate, tidal volume, and minute ventilation.

12. The apparatus of claim 10 , wherein the indicator is an icon or graphic on the display that provides the visual and/or numeric indication of the volumetric flow of breathing gas.

13. The apparatus of claim 10 , wherein the volumetric flow of breathing gas is one or more of an average flow rate, an instantaneous flow rate, a peak flow rate and a minimum measured flow rate.

14. The apparatus of claim 10 , wherein the display comprises a visual indication of the calculated delivery concentration of nitric oxide as a percentage of the desired delivery concentration.

15. The apparatus of claim 1 , further comprising a sample block that analyzes the concentration of nitric oxide, oxygen, and/or nitrogen dioxide in the gas mixture.

16. The apparatus of claim 15 , wherein the display provides a visual indication of the concentration of nitric oxide, oxygen, and/or nitrogen dioxide in the gas mixture.

17. The apparatus of claim 15 , wherein the sample block draws a volume of combined therapeutic and breathing gas of less than or equal to 250 mL/min, less than or equal to 100 mL/min, than or equal to 50 mL/min, or than or equal to 20 mL/min.

18. The apparatus of claim 1 , wherein the therapeutic gas injector module is a neo-injector module operable to determine flow rates below 2 L/min.

19. The apparatus of claim 18 , wherein the the second inlet has an inner diameter of 14 mm to 20 mm.

20. The apparatus of claim 18 , wherein the neo-injector module has an internal taper diameter of 4 mm to 7 mm between the second inlet and the outlet.

21. The apparatus of claim 18 , wherein the neo-injector module and flow sensor are adapted to determine flow of breathing gas as low as 0.25 L/min.

22. The apparatus of claim 1 , wherein the breathing gas delivery system comprises a ventilation apparatus.

23. The apparatus of claim 1 , further comprising a therapeutic gas flow sensor operable to measure the flow rate of the therapeutic gas; and a CPU operable to calculate the delivered concentration of the therapeutic gas in the combined flow.

24. The apparatus of claim 1 , wherein the flow sensor is in fluid communication with and downstream of the second inlet and monitors the flow of breathing gas through the therapeutic injector module.

25. The apparatus of claim 1 , wherein the flow sensor is part of the therapeutic injector module.

26. The apparatus of claim 1 , wherein the display provides a visual indication of the nitric oxide concentration in the therapeutic gas supply.

Assignments (14)
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: 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 →
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 →
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 →
Cited By (5)
US 12,509,349 US 12,522,501 US 12,569,628 US 12,576,234 US 12,606,436