IP Library Granted Patent US 11,786,687
Granted Patent B2
US 11,786,687 · App. 16/785,978 · Granted Oct 17, 2023

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
A61M16/0677A61M16/009A61M16/0666A61M16/0672A61M16/0875A61M16/10A61M16/104A61M16/1005A61M16/122A61M16/125A61M16/204A61M16/208A61M16/101A61M2016/0021A61M2016/0027A61M2202/0208A61M2202/0266A61M2202/0275A61M2202/0283A61M2205/0216A61M2205/3303A61M2205/3331A61M2205/75A61M2210/0618
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Quick Facts
Patent No.
US 11,786,687
App. No.
16/785,978
Granted
Oct 17, 2023
Kind
B2
Abstract

The present invention generally relates to, amongst other things, systems, devices, materials, and methods that can improve the accuracy and/or precision of nitric oxide therapy by, for example, reducing the dilution of inhaled nitric oxide (NO). As described herein, NO dilution can occur because of various factors. To reduce the dilution of an intended NO dose, various exemplary nasal cannulas, pneumatic configurations, methods of manufacturing, and methods of use, etc. are disclosed.

Claims (145)

1. A nasal cannula for therapeutic gas delivered to a patient in need thereof, comprising:

a first lumen, a second lumen, and a third lumen;

wherein the first lumen is a first therapeutic gas lumen for delivering a first therapeutic gas to a patient in need thereof,

wherein the second lumen is a triggering lumen, and

wherein the third lumen is a second therapeutic gas lumen for delivering a second therapeutic gas to the patient; and

a cannula nosepiece allowing separate flow paths to the patient for at least one of (i) the first therapeutic gas lumen, (ii) the triggering lumen, and (iii) the second therapeutic gas lumen,

wherein the first therapeutic gas lumen comprises a material selected from the group consisting of polyvinylidene chloride (PVDC) and ethylene vinyl alcohol (EVOH),

wherein the first therapeutic gas lumen comprises a co-extrusion of polyvinyl chloride (PVC) and EVOH or a co-extrusion of PVC and PVDC.

2. The nasal cannula of claim 1 , wherein the nasal cannula (i) reduces dilution of one or more of the first and second therapeutic gases delivered to the patient or (ii) is configured to be placed in fluid communication with at least one system to deliver one or more of the first and second therapeutic gases to the patient, or both.

3. The nasal cannula of claim 1 , wherein the nasal cannula at least one of inhibits mixing of nitric oxide and oxygen and reduces delivery of nitrogen dioxide to the patient.

4. The nasal cannula of claim 1 , wherein the first therapeutic gas is nitric oxide and the second therapeutic gas is oxygen, and wherein the first therapeutic gas lumen for delivering nitric oxide is smaller than the second therapeutic gas lumen for delivering oxygen and the triggering lumen.

5. The nasal cannula of claim 1 , wherein the first therapeutic gas is nitric oxide and the first therapeutic gas lumen for delivering nitric oxide is about six feet to about eight feet in length having an inner diameter of about 0.01 inches to about 0.10 inches.

6. The nasal cannula of claim 1 , wherein the first therapeutic gas is nitric oxide and the cannula nosepiece comprises a nitric oxide flow path having an inner diameter that is smaller than an inner diameter of the first therapeutic gas lumen.

7. The nasal cannula of claim 1 , wherein the first therapeutic gas is nitric oxide and the cannula nosepiece comprises a nitric oxide flow path having a volume that is less than about 10% of a minimum pulse volume of a pulse of nitric oxide.

8. The nasal cannula of claim 1 , wherein the cannula comprises a wall material having a low oxygen transmission rate that is between

0.001

(

cm

3

)

(

mil

)

(

24

hrs

)

(

100

in

2

)

(

ATM

)

and

10

(

cm

3

)

(

mil

)

(

24

hrs

)

(

100

in

2

)

(

ATM

)

.

9. The nasal cannula of claim 1 , wherein the cannula is further comprising a fourth lumen:

the fourth lumen being another first therapeutic gas lumen for delivering the first therapeutic gas to the patient; and

wherein the first lumen delivers the first therapeutic gas to one nostril of the patient and the fourth lumen delivers the first therapeutic gas to another nostril of the patient.

10. The nasal cannula of claim 1 , further comprising one or more of: (i) at least one check valve in fluid communication with the first therapeutic gas lumen, (ii) a cannula key, (iii) a scavenging material, and (iv) a flexible support bridge.

11. A nasal cannula for therapeutic gas delivered to a patient in need thereof, comprising:

a first lumen, a second lumen, and a third lumen;

wherein the first lumen is a first therapeutic gas lumen for delivering a first therapeutic gas to a patient,

wherein the second lumen is a triggering lumen for triggering release of a pulse of the first therapeutic gas, and

wherein the third lumen is a second therapeutic gas lumen for delivering a second therapeutic gas to the patient;

the first therapeutic gas lumen, the triggering lumen, and the second therapeutic gas lumen aggregating at a cannula nosepiece, the cannula nosepiece allowing separate flow paths to the patient for each of the first therapeutic gas lumen, the triggering lumen, and the second therapeutic gas lumen; and

the first therapeutic gas lumen having an inner diameter that is one or more of (i) smaller than an inner diameter of the second therapeutic gas lumen and an inner diameter of the triggering lumen and (ii) larger than an inner diameter of the flow path for the first therapeutic gas lumen at the cannula nosepiece,

wherein the first therapeutic gas lumen comprises a material selected from the group consisting of polyvinylidene chloride (PVDC) and ethylene vinyl alcohol (EVOH),

wherein the first therapeutic gas lumen comprises a co-extrusion of polyvinyl chloride (PVC) and EVOH or a co-extrusion of PVC and PVDC.

12. The nasal cannula of claim 11 , wherein the nasal cannula (i) reduces dilution of one or more of the first and second therapeutic gases delivered to the patient or (ii) is configured to be placed in fluid communication with at least one system to deliver one or more of the first and second therapeutic gases to the patient, or both.

13. The nasal cannula of claim 11 , wherein the nasal cannula at least one of inhibits mixing of nitric oxide and oxygen and reduces delivery of nitrogen dioxide to the patient.

14. The nasal cannula of claim 11 , wherein the first therapeutic gas is nitric oxide and the first therapeutic gas lumen for delivering nitric oxide is about six feet to about eight feet in length having an inner diameter of about 0.01 inches to about 0.10 inches.

15. The nasal cannula of claim 11 , wherein the first therapeutic gas is nitric oxide and the cannula nosepiece comprises a nitric oxide flow path having a volume that is less than about 10% of a minimum pulse volume of a pulse of nitric oxide.

16. The nasal cannula of claim 11 , wherein the cannula comprises a wall material having a low oxygen transmission rate that is between

0.001

(

cm

3

)

(

mil

)

(

24

hrs

)

(

100

in

2

)

(

ATM

)

and

10

(

cm

3

)

(

mil

)

(

24

hrs

)

(

100

in

2

)

(

ATM

)

.

17. The nasal cannula of claim 1 , wherein the co-extrusion further comprises a tie layer.

18. The nasal cannula of claim 11 , wherein the co-extrusion further comprises a tie layer.

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 075393/0921 →
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 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 →
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 →
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 →
Continuity (7)
Continuation 15412348 · Jan 23, 2017
Continuation 14312003 · Jun 23, 2014
Continuation 14096629 · Dec 4, 2013
Provisional Application 61856367 · Jul 19, 2013
Provisional Application 61784238 · Mar 14, 2013
Provisional Application 61733134 · Dec 4, 2012
Related Publication 20200171259A1 · Jun 4, 2020