IP Library Granted Patent US 10,894,140
Granted Patent B2
US 10,894,140 · App. 15/281,512 · Granted Jan 19, 2021

Device and method for diffusing high concentration NO with inhalation therapy gas

Inventors: John C. Falligant (Mount Horeb, WI); Craig R. Tolmie (Stoughton, WI)
Assignee: Mallinckrodt Hospital Products IP Unlimited Company
A61M16/12A61M11/00A61M16/0875A61M16/203A61M2202/0208A61M2202/0275A61M2205/3334
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Quick Facts
Patent No.
US 10,894,140
App. No.
15/281,512
Granted
Jan 19, 2021
Kind
B2
Abstract

Systems and methods of the present invention can enable high concentration NO to be delivered into ventilator breathing circuits, via a diffusing device, without generating undesirably large amounts of NO 2 .

Claims (35)

1. A diffusing device for injecting a high concentration gas into a transverse gas stream, the diffusion device comprising:

a body comprising a wall having a thickness, an outer surface, and an inner surface surrounding a hollow internal region;

a projection extending from the inner surface of the body and into the hollow internal region; and

an injection channel passing through the wall and projection to an injection port such that the injection port injects the high concentration gas into the transverse gas stream at a distance from the inner surface of the body, wherein the injection port has an outlet recessed from a center of the hollow internal region, and wherein an orifice is located within the flow path of the injection channel and injection port, and the orifice size provides a ratio of the velocity of the transverse gas and the velocity of the high concentration gas, wherein the ratio is less than 2:1.

2. The diffusing device of claim 1 , wherein the hollow internal region has a diameter, and a length of the projection from the inner surface to the injection port outlet is in the range of about 30% to about 45% of the diameter of the hollow internal region.

3. The diffusing device of claim 1 , wherein the injection port has an inside diameter in the range of about 0.7 mm to about 2.4 mm.

4. The diffusing device of claim 1 , wherein the body is an annular body comprising a cylindrical wall having an outside diameter in the range of about 10 mm to about 25 mm, and an inside diameter in the range of about 10 mm to about 25 mm, wherein the inside diameter is smaller than the outside diameter by the thickness of the cylindrical wall.

5. The diffusing device of claim 4 , wherein the thickness of the cylindrical wall is in the range of about 1 mm to about 3.175 mm, and the injection channel forms an angle in the range of about 60° to about 120° with a longitudinal axis of the hollow internal region.

6. The diffusing device of claim 1 , wherein the diffusing device is configured and dimensioned for insertion into respiratory tubing.

7. The diffusing device of claim 1 , wherein the diffusing device is integral to an injector module comprising a flow sensor.

8. The diffusing device of claim 1 , wherein the diffusing device comprises a plurality of injection ports.

9. The diffusing device of claim 1 , wherein one or more of (i) the injection channel or (ii) the injection port has a proportional valve or a variable orifice.

10. The diffusing device of claim 1 , further comprising a mixing device comprising a plurality of blades, plates and/or fins.

11. The diffusing device of claim 1 , wherein the projection comprises a nozzle.

12. The diffusing device of claim 1 , further comprising a female connector configured and dimensioned for connection to a delivery tube carrying the high concentration gas.

13. A method of diffusing a high concentration gas into a transverse gas stream, comprising:

passing at least a portion of a first gas through a hollow internal region of a body having an inner surface surrounding the hollow internal region; and

passing a second gas stream through an injection channel to an injection port projecting into the hollow internal region of the body, wherein the second gas stream enters and at least partially diffuses with the first gas stream within the hollow internal region,

wherein the first gas stream has a first velocity and the second gas stream has a second velocity, and the ratio of the first velocity to the second velocity is less than 2:1.

14. The method of claim 13 , wherein the second gas stream initially enters the first gas stream at an angle in the range of about 60° to about 120°.

15. The method of claim 13 , wherein the first gas is a breathable gas comprising molecular N 2 and molecular O 2 , and the second gas comprises molecular NO and molecular N 2 .

16. The method of claim 15 , wherein the concentration of NO in the second gas is in the range of greater than 400 ppm to about 10,000 ppm.

17. The method of claim 13 , wherein the flow rate of the second gas is linearly proportional to the flow rate of the first gas.

18. The method of claim 13 , wherein the ratio of the first velocity to the second velocity is less than or equal to about 1:1.

19. The method of claim 18 , wherein the ratio of less than or equal to about 1:1 is provided when the first gas stream has a volumetric flow rate of less than 2 SLPM.

20. The method of claim 13 , wherein the second gas stream enters the first gas stream at or near the central midpoint of the highest velocity of the first gas stream.

21. The method of claim 13 , wherein the second gas stream is injected into the first gas stream as a plurality of pulses.

22. A method of diffusing a high concentration NO-containing gas into a transverse oxygen-containing gas stream, the method comprising:

receiving a dose of NO from a user;

receiving a first gas stream comprising oxygen through a hollow internal region of a body having an inner surface surrounding the hollow internal region; and

passing a second gas stream comprising NO through an injection channel to an injection port projecting into the hollow internal region of the body, wherein the second gas stream enters and at least partially diffuses with the first gas stream within the hollow internal region, wherein the injection port has an outlet recessed from a center of the hollow internal region and wherein an orifice is located within the flow path of the injection channel and injection port, and the orifice size provides a ratio of the velocity of the first gas and the velocity of the second gas, wherein the ratio is less than 2:1.

23. The method of claim 22 , wherein the ratio of less than 2:1 is provided when the first gas stream has a volumetric flow rate of less than 2 SLPM.

24. The method of claim 22 , further comprising selecting an orifice size of a variable-sized orifice.

25. The method of claim 22 , further comprising selecting an orifice from a plurality of orifices having varying orifice diameters.

26. The method of claim 22 , wherein the second gas stream is injected into the first gas stream as a plurality of pulses to provide the set dose of NO in a combined gas stream of the first gas stream and the second gas stream.

Assignments (18)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2026
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED COMPANY
Reel/Frame 075393/0608 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 16, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 072040/0424 →
CHANGE OF NAME Recorded Aug 16, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 072477/0834 →
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: SPECGX LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS 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 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 043601, FRAME 0025 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 065610/0233 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2018
From: FALLIGANT, JOHN C.; TOLMIE, CRAIG R.
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 046001/0703 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Aug 18, 2017
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 043601/0025 →
Continuity (2)
Provisional Application 62235798 · Oct 1, 2015
Related Publication 20170095633A1 · Apr 6, 2017