IP Library Granted Patent US 10,835,696
Granted Patent B2
US 10,835,696 · App. 16/058,402 · Granted Nov 17, 2020

Systems and method for delivery of therapeutic gas to patients, in need thereof, receiving breathing gas from a ventilator that varies at least pressure and/or flow using enhanced therapeutic gas (NO) flow measurement

Inventors: Jaron M. Acker (Madison, WI); Craig R. Tolmie (Stoughton, WI)
Assignee: Mallinckrodt Hospital Products IP Limited
A61M16/00A61M16/0003A61M16/0057A61M16/024A61M16/06A61M16/12A61M16/122A61M16/201A61M2016/003A61M2016/0039A61M2202/0275A61M2202/0283A61M2205/15A61M2205/3334A61M2205/35
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Quick Facts
Patent No.
US 10,835,696
App. No.
16/058,402
Granted
Nov 17, 2020
Kind
B2
Abstract

The present disclosure generally relates to systems and methods for delivery of therapeutic gas to patients, in need thereof, receiving breathing gas from a high frequency ventilator using at least enhanced therapeutic gas (e.g., nitric oxide, NO, etc.) flow measurement. At least some of these enhanced therapeutic gas flow measurements can be used to address some surprising phenomenon that may, at times, occur when wild stream blending therapeutic gas into breathing gas a patient receives from a breathing circuit affiliated with a high frequency ventilator. Utilizing at least some of these enhanced therapeutic gas flow measurements the dose of therapeutic gas wild stream blended into breathing gas that the patient receives can at least be more accurate and/or under delivery of therapeutic gas into the breathing gas can be avoided and/or reduced.

Claims (35)

1. A method of delivering a therapeutic gas into a breathing gas in an inspiratory limb of a patient breathing circuit affiliated with a high frequency ventilator or ventilation techniques which provide reverse and/or oscillations in inspiratory pressure or flow, the method comprising:

providing, through at least one control valve of a nitric oxide delivery system, a flow of therapeutic gas containing nitric oxide (NO) to an injector module configured to inject the therapeutic gas into the breathing gas in the inspiratory limb of the patient breathing circuit;

measuring, using at least one NO flow sensor, NO flow at the at least one control valve, wherein the NO flow sensor is in fluid communication with a therapeutic gas inlet of the injector module;

receiving, using a control system in communication with the at least one NO flow sensor, flow information from the at least one NO flow sensor;

wherein the control system is operable to:

(i) detect use of the high frequency ventilator;

(ii) compensate for false NO flow phenomenon by treating the flow information generated by the high frequency ventilator as noise and filtering this noise out and/or using noise reduction techniques;

(iii) identify the flow information as missing and interpolates the missing flow information; and/or

(iv) identify the flow information as reverse flow and inverts the value of the flow information.

2. The method of claim 1 , wherein the control system is operable to detect false NO flow phenomenon by analyzing user input information, using a noise detection algorithm, and/or signal recovery algorithm.

3. The method of claim 1 , wherein the control system is operable to use the flow information to ensure that a desired dose of NO is delivered into the injector module, and in turn into patient breathing gas in the inspiratory limb of the breathing circuit.

4. The method of claim 1 , wherein the control system is operable to use the flow information to ensure that a desired dose of NO is not under delivered and/or under dosed.

5. The method of claim 1 , further comprising opening or closing a check valve in response to false NO flow, wherein the check valve is one or more of (i) in fluid communication with the therapeutic gas inlet of the injector module and (ii) is integral to the injector module.

6. The method of claim 1 , wherein the control valve is upstream of the NO flow sensor in the nitric oxide delivery system.

7. The method of claim 1 , wherein the therapeutic gas inlet receives the flow of therapeutic gas via a conduit, and the conduit one or more of (i) has internal cross-sectional diameter of about 1/32 of an inch to about ¼ of an inch and (ii) has an internal portion within the nitric oxide delivery system and an external portion outside the nitric oxide delivery system, the internal portion of the conduit having a cross-sectional diameter that is substantially the same as a cross-sectional diameter of the external portion of the conduit.

8. The method of claim 1 , further comprising:

measuring, using at least a second NO flow sensor, NO flow, wherein the second NO flow sensor is in fluid communication with the therapeutic gas inlet and in communication with the control system,

wherein the control system is operable to receive flow information from the NO flow sensors and detects a leak when the flow information from the NO flow sensors does not match.

9. The method of claim 8 , wherein the flow of therapeutic gas is increased if a leak is detected.

10. A method for delivering a therapeutic gas into a breathing gas in an inspiratory limb of a patient breathing circuit affiliated with a high frequency ventilator or ventilation techniques which provide reverse and/or oscillations in inspiratory pressure or flow, the method comprising:

providing, using at least one control valve of a nitric oxide delivery system, a flow of therapeutic gas;

measuring, using at least one bi-directional NO flow sensor, NO flow in a forward direction and in a reverse direction through a therapeutic gas inlet of an injector module, wherein the least one bi-directional NO flow sensor is in fluid communication with the therapeutic gas inlet of the injector module; and

receiving, using a control system in communication with the at least one bi-directional NO flow sensor, bi-directional flow information comprising at least forward flow information and reverse flow information from the at least one bi-directional NO flow sensor.

11. The method of claim 10 , wherein the control system is operable to detect false NO flow phenomenon by analyzing user input, detection algorithm, and/or signal recovery.

12. The method of claim 10 , wherein the control system is operable to use the bi-directional flow information to compensate for false NO flow phenomenon by treating flow information generated by the high frequency ventilator as noise and filtering this noise out and/or using noise reduction techniques.

13. The method of claim 10 , wherein the control system is operable to use the bi-directional flow information to ensure that a desired dose of NO is delivered into the injector module, and in turn into patient breathing gas in the inspiratory limb of the breathing circuit.

14. The method of claim 10 , wherein the control system is operable to use the bi-directional flow information to ensure that a desired dose of NO is not under delivered and/or under dosed.

15. The method of claim 10 , further comprising opening or closing a check valve in response to false NO flow, wherein the check valve that is one or more of (i) in fluid communication with the therapeutic gas inlet of the injector module and (ii) is integral to the injector module.

16. The method of claim 10 , wherein the therapeutic gas comprises one or more of (i) nitric oxide and (ii) a nitric-oxide releasing agent.

17. The method of claim 10 , wherein the control valve is upstream of the NO flow sensor in the nitric oxide delivery system.

18. The method of claim 10 , wherein the therapeutic gas inlet receives the flow of therapeutic gas via a conduit, and the conduit one or more of (i) has internal cross-sectional diameter of about 1/32 of an inch to about ¼ of an inch and (ii) has an internal portion within the nitric oxide delivery system and an external portion outside the nitric oxide delivery system, the internal portion of the conduit having a cross-sectional diameter that is substantially the same as a cross-sectional diameter of the external portion of the conduit.

19. The method of claim 10 , further comprising:

measuring NO flow using at least a second NO flow sensor in fluid communication with the therapeutic gas inlet and in communication with the control system,

wherein the control system receives flow information from the NO flow sensors and detects a leak when the flow information from the NO flow sensors does not match.

20. The method of claim 19 , wherein the flow of therapeutic gas is increased if a leak is detected.

Assignments (14)
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 →
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 →
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 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 →