IP Library Granted Patent US 10,918,819
Granted Patent B2
US 10,918,819 · App. 15/790,300 · Granted Feb 16, 2021

Cannula for minimizing dilution of dosing during nitric oxide delivery

Inventors: Craig Flanagan (Belmar, NJ); Simon Freed (Providence, RI); John Klaus (Cottage Grove, WI); Thomas Kohlmann (McFarland, WI); Martin D. Meglasson (Bloomsbury, NJ); Manesh Naidu (Randolph, NJ); Parag Shah (Morristown, NJ)
Assignee: Mallinckrodt Hospital Products IP Limited
A61M16/0677A61M16/06A61M16/0666A61M16/0672A61M16/0858A61M16/208A61M2202/0208A61M2202/0275A61M2206/10A61M2207/00
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Quick Facts
Patent No.
US 10,918,819
App. No.
15/790,300
Granted
Feb 16, 2021
Kind
B2
Abstract

Described are nasal cannulas that improve the precision of the delivered dose for nitric oxide therapy by reducing the dilution of nitric oxide. The nasal cannulas may reduce the total volume and potential for retrograde flow during nitric oxide therapy through the design of the specific dimensions of the flow path and/or having check valves in the nitric oxide delivery line and/or having a flapper or umbrella valve dedicated to nitric oxide delivery. The nasal cannulas may also use materials that limit oxygen diffusion through the cannula walls. The nosepiece for these cannulas may be manufactured by a molding technique.

Claims (38)

1. A method of administering nitric oxide for treating pulmonary hypertension, the method comprising:

administering a pulse of a gas comprising nitric oxide to a patient in need thereof, wherein the pulse is administered through a nasal cannula comprising a cannula nosepiece comprising a nitric oxide flow path having a volume that is less than 20% of a volume of pulse of the gas comprising nitric oxide.

2. The method of claim 1 , wherein the nasal cannula comprises:

a first lumen, a second lumen, and a third lumen:

the first lumen being a first therapeutic gas lumen for delivering the gas comprising nitric oxide to the patient,

the second lumen being a triggering lumen, and

the third lumen being a second therapeutic gas lumen for delivering a gas comprising oxygen to the patient; and

wherein the cannula nosepiece has separate flow paths to the patient for each of (i) the first therapeutic gas lumen, (ii) the triggering lumen, and (iii) the second therapeutic gas lumen.

3. The method of claim 1 , wherein the nitric oxide flow path comprises a first prong, a second prong and a prong spacing.

4. The method of claim 1 , wherein the nasal cannula comprises a first lumen for delivering the gas comprising nitric oxide to the patient and a second lumen, wherein the first lumen has a smaller inner diameter than an inner diameter of the second lumen.

5. The method of claim 1 , wherein the pulse of gas comprising nitric oxide has a volume less than 1 mL.

6. The method of claim 1 , wherein the nitric oxide flow path is less than 10% of the volume of pulse of the gas comprising nitric oxide.

7. The method of claim 1 , wherein the nitric oxide flow path has a volume less than or equal to 0.035 mL.

8. A method of administering nitric oxide for treating pulmonary hypertension, the method comprising:

administering a plurality of pulses of a gas comprising nitric oxide to a patient in need thereof, wherein the plurality of pulses are administered through a nasal cannula comprising a cannula nosepiece comprising a nitric oxide flow path having a volume that is less than 20% of a volume of each of the plurality of pulses of the gas comprising nitric oxide.

9. The method of claim 8 , wherein the nasal cannula comprises:

a first lumen, a second lumen, and a third lumen:

the first lumen being a first therapeutic gas lumen for delivering a gas comprising nitric oxide to the patient,

the second lumen being a triggering lumen, and

the third lumen being a second therapeutic gas lumen for delivering a gas comprising oxygen to the patient; and

wherein the cannula nosepiece has separate flow paths to the patient for each of (i) the first therapeutic gas lumen, (ii) the triggering lumen, and (iii) the second therapeutic gas lumen.

10. The method of claim 8 , wherein the nitric oxide flow path comprises a first prong, a second prong and a prong spacing.

11. The method of claim 8 , wherein the nasal cannula comprises a first lumen for delivering the gas comprising nitric oxide to the patient and a second lumen, wherein the first lumen has a smaller inner diameter than an inner diameter of the second lumen.

12. The method of claim 8 , wherein each of the plurality of pulses of the gas comprising nitric oxide has a volume less than 1 mL.

13. The method of claim 8 , wherein the nitric oxide flow path is less than 10% of the volume of each of the plurality of pulses of the gas comprising nitric oxide.

14. The method of claim 8 , wherein the nitric oxide flow path has a volume less than or equal to 0.035 mL.

15. A method of administering nitric oxide to a patient, the method comprising:

administering a plurality of pulses of a gas comprising nitric oxide to the patient, wherein the plurality of pulses are administered through a nasal cannula comprising a cannula nosepiece comprising a nitric oxide flow path having a volume that is less than 20% of a volume of each of the plurality of pulses of the gas comprising nitric oxide.

16. The method of claim 15 , wherein the nasal cannula comprises:

a first lumen, a second lumen, and a third lumen:

the first lumen being a first therapeutic gas lumen for delivering a gas comprising nitric oxide to the patient,

the second lumen being a triggering lumen, and

the third lumen being a second therapeutic gas lumen for delivering a gas comprising oxygen to the patient; and

wherein the cannula nosepiece has separate flow paths to the patient for each of (i) the first therapeutic gas lumen, (ii) the triggering lumen, and (iii) the second therapeutic gas lumen.

17. The method of claim 15 , wherein the nitric oxide flow path comprises a first prong, a second prong and a prong spacing.

18. The method of claim 15 , wherein the nasal cannula comprises a first lumen for delivering the gas comprising nitric oxide to the patient and a second lumen, wherein the first lumen has a smaller inner diameter than an inner diameter of the second lumen.

19. The method of claim 15 , wherein each of the plurality of pulses of the gas comprising nitric oxide has a volume less than 1 mL.

20. The method of claim 15 , wherein the nitric oxide flow path is less than 10% of the volume of each of the plurality of pulses of the gas comprising nitric oxide.

Assignments (15)
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 →
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 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 →
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 →
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 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 →
Continuity (4)
Continuation 14096548 · Dec 4, 2013
Provisional Application 61733134 · Dec 4, 2012
Provisional Application 61784238 · Mar 14, 2013
Related Publication 20180104432A1 · Apr 19, 2018