IP Library Granted Patent US 11,291,794
Granted Patent B2
US 11,291,794 · App. 16/598,786 · Granted Apr 5, 2022

Compensating for disruptions in breathing gas flow measurement

Inventors: Jaron M. Acker (Madison, WI); Craig R. Tolmie (Stoughton, WI)
Assignee: Mallinckrodt Pharmaceuticals Ireland Limited
A61M16/125A61M16/0051A61M16/0069A61M16/024A61M16/104A61M2016/0033A61M2016/0039A61M2016/1025A61M2016/1035A61M2202/0275A61M2205/3334A61M2205/52A61M2230/435A61M2230/437
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Quick Facts
Patent No.
US 11,291,794
App. No.
16/598,786
Granted
Apr 5, 2022
Kind
B2
Abstract

The present disclosure generally relates to systems and methods for delivery of therapeutic gas to patients, using techniques to compensate for disruptions in breathing gas flow measurement, such as when breathing gas flow measurement is unavailable or unreliable. Such techniques include using historical breathing gas flow rate data, such as moving average flow rates, moving median flow rates and/or flow waveforms. At least some of these techniques can be used to ensure that interruption in therapeutic gas delivery is minimized or eliminated.

Claims (41)

1. A nitric oxide gas delivery apparatus for use with a ventilator, the apparatus comprising:

an injector module operable to be placed in fluid communication with a breathing circuit affiliated with the ventilator, the injector module comprising:

a breathing gas flow inlet;

a nitric oxide (NO) flow inlet; and

a combined breathing gas and NO flow outlet operable to provide a combined flow of breathing gas and NO to a patient, in need thereof;

a breathing gas flow sensor configured to sense breathing gas flow rate;

one or more NO flow sensors operable to measure the flow of NO; and

a controller comprising:

a memory operable to track and store historical NO flow rate data by the one or more NO flow sensors; and

a processor operable to calculate a historical average NO flow rate from the historical NO flow rate data in a first mode and detect a disruption of breathing gas flow rate data from the breathing gas flow sensor,

wherein upon detection of the disruption in breathing gas flow rate data, the controller operates in a backup mode to control a delivery flow rate of the NO based on the historical average NO flow rate.

2. The apparatus of claim 1 , wherein the controller operating in backup mode controls the delivery flow rate of the NO at the historical average NO flow rate.

3. The apparatus of claim 1 , wherein the historical average NO flow rate is referenced to calculate a desired NO flow rate for a new set dose of NO.

4. The apparatus of claim 1 , further comprising a user input, wherein when the controller is operating in backup mode, a record in the memory from the user input controls the delivery flow rate of the NO.

5. The apparatus of claim 1 , further comprising a display, wherein when the controller is operating in the backup mode, the historical average NO flow rate is displayed on the display.

6. The apparatus of claim 1 , further comprising a control valve operable to regulate flow of the NO through a conduit to the injector module.

7. The apparatus of claim 6 , wherein the one or more NO flow sensors are located upstream from the control valve and/or the conduit, and wherein the one or more NO flow sensors are operable to measure the flow of NO through the NO flow inlet into the injector module.

8. The apparatus of claim 6 , wherein the one or more NO flow sensors are located downstream from the control valve and/or the conduit, and wherein the one or more NO flow sensors are operable to measure the flow of NO through the NO flow inlet into the injector module.

9. The apparatus of claim 1 , wherein the controller is operable to automatically return to the first mode upon detection that the disruption has ended and/or that the breathing gas flow sensor has been at least one of reconnected, replaced, and/or serviced.

10. The apparatus of claim 1 , wherein the controller is configured to automatically resume delivery of a flow of NO based on the first mode, upon detection and/or input that the breathing gas flow sensor has been at least one of reconnected, replaced, and/or serviced.

11. The apparatus of claim 1 , wherein the historical NO flow rate data is stored over a period in the range from 10 seconds to 5 minutes.

12. The apparatus of claim 1 , wherein the sensed breathing gas flow rate data is received from the injector module and/or the ventilator.

13. The apparatus of claim 1 , wherein the sensed breathing gas flow rate data comprises first breathing gas flow rate data and second breathing gas flow rate data, and wherein the first breathing gas flow rate data is received from the injector module and/or the second breathing gas flow rate data is received from the ventilator.

14. The apparatus of claim 13 , wherein the controller compares respective flow rate data from the first breathing gas flow rate data with the second breathing gas flow rate data.

15. The apparatus of claim 1 , wherein the controller is further operable to utilize at least one of data smoothing and/or low-pass filtering to remove outlying stored flow data points.

16. A method for delivery of nitric oxide (NO) gas to a patient, the method comprising:

controlling, via a controller, a NO flow to a patient in a first mode;

receiving, via a breathing gas sensor, sensed flow rate of breathing gas flow;

receiving, via one or more NO flow sensors, measured flow rate of NO flow;

storing in a memory historical NO flow rate data related to the received NO flow rate by the one or more NO sensors;

calculating, via a processor, a historical average NO flow rate from the historical NO flow rate data in the first mode;

detecting a disruption of the sensed breathing gas flow rate data from the breathing gas sensor; and

controlling, via the controller, the NO flow in a backup mode instead of the first mode, based on the historical average NO flow rate.

17. The method of claim 16 , further comprising displaying the historical average NO flow rate on a display when the controller is operating in the backup mode.

18. The method of claim 16 , wherein when the controller is operating in backup mode, a record in the memory from a user input controls the flow rate of the NO.

19. The method of claim 16 , wherein storing the historical NO flow rate data includes storing the historical NO flow rate data over a period in the range from 10 seconds to 5 minutes.

20. The method of claim 16 , further comprising:

returning to the first mode when a discontinuance of the disruption is detected.

21. The method of claim 20 , wherein:

receiving the received breathing gas flow rate data includes receiving a first breathing gas flow rate data and a second breathing gas flow rate data, and

detecting the disruption includes detecting the disruption by comparing respective flow rate data between the first and second breathing gas flow rate data.

Assignments (11)
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 051231, FRAME 0961 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 065609/0811 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2021
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 056433/0640 →
CHANGE OF NAME Recorded Jun 3, 2021
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 056476/0162 →
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 Dec 9, 2019
From: MALLINCKRODT LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT PHARMA IP TRADING D.A.C.
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 051231/0961 →