IP Library Granted Patent US 11,833,299
Granted Patent B2
US 11,833,299 · App. 16/677,435 · Granted Dec 5, 2023

Clinical decision support system and methods

Inventors: Jaron Acker (New York, NY); Craig R. Tolmie (Stoughton, WI)
Assignee: Mallinckrodt Pharmaceuticals Ireland Limited
A61M16/0051A61M16/024A61M16/104A61M16/12G16H20/10G16H50/20A61M16/0672A61M2016/0039A61M2202/0275A61M2205/505A61M2205/581A61M2205/583
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Quick Facts
Patent No.
US 11,833,299
App. No.
16/677,435
Granted
Dec 5, 2023
Kind
B2
Abstract

The present invention provides clinical decision support that can be used with non-portable and portable systems when delivering and/or monitoring delivery of a therapeutic gas comprising nitric oxide to a patient. Further, clinical decision support can be used with non-portable and portable systems during delivery and/or monitoring of delivery of therapeutic gas when nebulized drugs may and/or may not be being delivered to a patient (e.g., when nebulizers are delivered upstream in the inspiratory limb of the breathing circuit, into a breathing gas delivery system, etc.).

Claims (50)

1. A delivery system, comprising:

a control module comprising one or more processors and a processor readable memory, the control module configured to control a flow of therapeutic gas comprising nitric oxide that is mixed with a flow of breathing gas to form a gas mixture into a nebulizer device for delivery of the gas mixture to a patient;

a sample block configured to evaluate a presence and concentration of one or more of nitric oxide, oxygen and nitrogen dioxide in the gas mixture; and

a display configured to display an option to activate a nebulizer mode and receive run information including start nebulizer mode information and duration run nebulizer mode information,

wherein the control module is configured to:

store logic based information for the nebulizer mode, the start nebulizer mode information, and the duration run nebulizer mode information,

cause the sample block to cease evaluating the gas mixture in response to an input that the nebulizer device is in use for a duration of time based on the received duration run nebulizer mode information while continuing to deliver the gas mixture to the patient through the nebulizer device,

return to evaluating the gas mixture after the duration of time, and

cause to be presented on the display a calculated delivery dose of nitric oxide when the sample block is not evaluating the gas mixture and a measured concentration of nitric oxide when the sample block is evaluating.

2. The delivery system of claim 1 wherein the input is a user input.

3. The delivery system of claim 1 wherein the sample block receives a portion of the gas mixture via a sample line.

4. The delivery system of claim 1 wherein the control module is configured to cause to be presented on the display a calculated delivery dose when the sample block is not evaluating the gas mixture.

5. The delivery system of claim 1 wherein the duration of time is input by a user.

6. The delivery system of claim 5 wherein the sample block is integrated with the control module.

7. A therapeutic gas delivery system

a source of a therapeutic gas comprising nitric oxide;

a control module configured to control a flow of therapeutic gas from the therapeutic gas source to a therapeutic injector module where the therapeutic gas is combined with a breathing gas to form a gas mixture for delivery into a nebulizer device for delivery of the gas mixture to a patient; and

a display configured to display an option to activate a nebulizer mode and receive run information including start nebulizer mode information and duration run nebulizer mode information,

wherein the control module is configured to:

test the gas mixture for at least one of nitric oxide concentration, oxygen concentration, and nitrogen dioxide concentration when the control module is not operating in the nebulizer mode,

not to test the gas mixture when the control module is operating in the nebulizer mode for a duration of time based on the received duration run nebulizer mode information while continuing to deliver the gas mixture to the patient through the nebulizer device,

return to testing the gas mixture after the duration of time, and

cause to be presented on the display a calculated delivery dose of nitric oxide when the gas mixture is not being tested and a measured concentration of nitric oxide when the gas mixture is being tested.

8. The therapeutic gas delivery system of claim 7 , wherein the control module is configured to cause to be presented on the display an indication that the control module is operating in the nebulizer mode.

9. The therapeutic gas delivery system of claim 8 wherein the control module is configured to enter the nebulizer mode in response to an input.

10. The therapeutic gas delivery system of claim 9 wherein the display is a touch screen display and the input is a user input to the touch screen display.

11. The therapeutic gas delivery system of claim 7 wherein the control module is configured to issue an alert when a calculated dosage of the therapeutic gas in the gas mixture is one of above a first threshold and below a second threshold.

12. A therapeutic gas delivery system, comprising:

a source of a therapeutic gas comprising nitric oxide;

a first inlet in fluid communication with the source of therapeutic gas;

a second inlet in fluid communication with a breathing gas delivery system configured to deliver breathing gas to a patient;

a therapeutic injector module in fluid communication with the first inlet, the second inlet, and an outlet leading to an inspiratory breathing hose;

the therapeutic injector module having a sensor configured to measure a flow rate of the breathing gas and being configured to deliver a gas mixture of the breathing gas and the therapeutic gas to the outlet for delivery into a nebulizer device for delivery of the gas mixture to the patient;

a control module including at least one processor, at least one memory and a sample block, and that is configured to control a flow of therapeutic gas into the first inlet;

a sample line in fluid communication with the inspiratory breathing hose and the sample block;

wherein the sample block is configured to selectively divert a portion of the gas mixture through the sample line and is configured to analyze one or more of concentration of nitric oxide, concentration of oxygen and concentration of nitrogen dioxide; and

wherein the control module is further configured to:

enter a nebulizer mode in response to an input, indicating that the nebulizer device is anticipated to influence the gas mixture,

cause the sample block to cease diverting the portion of the gas mixture while continuing to deliver the gas mixture to the patient through the nebulizer device,

return to testing the gas mixture after a duration of time, and

cause to be presented on the display a calculated delivery dose of nitric oxide when the gas mixture is not being tested and a measured concentration of nitric oxide when the gas mixture is being tested.

13. The therapeutic gas delivery system of claim 12 , further comprising:

a display;

wherein the control module is configured to determine a calculated delivery concentration of nitric oxide using the flow rate of the breathing gas and a flow rate of the therapeutic gas; and

wherein the calculated delivery concentration is presented on the display when the control module is in the nebulizer mode.

14. The therapeutic gas delivery system of claim 13 wherein when the control module is not in the nebulizer mode it is configured to cause to be presented on the display one of a concentration of nitric oxide, a concentration of oxygen and a concentration of nitrogen dioxide as determined by the sample block.

15. The therapeutic gas delivery system of claim 13 wherein the input is a user input into the control module.

16. The therapeutic gas delivery system of claim 12 wherein the control module is configured to exit the nebulizer mode after a predetermined interval.

17. The therapeutic gas delivery system of claim 16 wherein the predetermined interval is determined from user input.

18. The therapeutic gas delivery system of claim 12 wherein the control module causes the sample block to continuously analyze the gas mixture when the control module is not in the nebulizer mode.

Assignments (18)
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 SECURITY INTEREST Recorded Nov 30, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); STRATATECH CORPORATION
Reel/Frame 065712/0988 →
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 052456, FRAME 0158 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 065609/0133 →
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 →
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 →
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 Apr 22, 2020
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; OCERA THERAPEUTICS, INC.; ST SHARED SERVICES LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 052463/0396 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Apr 21, 2020
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 052456/0158 →
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 →