IP Library Granted Patent US 10,130,783
Granted Patent B2
US 10,130,783 · App. 14/706,449 · Granted Nov 20, 2018

Cannula for minimizing dilution of dosing during nitric oxide delivery

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Quick Facts
Patent No.
US 10,130,783
App. No.
14/706,449
Granted
Nov 20, 2018
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 (86)

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

a first lumen, a second lumen and a cannula nosepiece:

the first lumen being a nitric oxide lumen connected to a nitric oxide source, the second lumen being a trigger lumen and/or an oxygen lumen; and

the first lumen and the second lumen aggregating at the cannula nosepiece, the cannula nosepiece having separate flow paths to the patient for the first lumen and the second lumen such that the nitric oxide and the oxygen do not mix in the cannula nosepiece, wherein the first lumen has an inner diameter that is smaller than the inner diameter of the second lumen but larger than an inner diameter of the flow path for the first lumen at the cannula nosepiece.

2. The nasal cannula of claim 1 , wherein the flow path for the first lumen at the cannula nosepiece comprises a first prong, a second prong and a backplane, with the first prong being in fluid communication with the second prong via the backplane and the total volume of the first prong, the second prong and the backplane being less than 0.035 mL.

3. The nasal cannula of claim 1 , wherein the nasal cannula (i) reduces dilution of one or more of the nitric oxide and the oxygen 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.

4. The nasal cannula of claim 1 , wherein the nasal cannula reduces delivery of nitrogen dioxide to the patient.

5. The nasal cannula of claim 1 , wherein the nasal cannula delivers one or more of the nitric oxide and the oxygen gases to the patient for treatment of pulmonary hypertension.

6. The nasal cannula of claim 5 , wherein the nasal cannula delivers one or more of the nitric oxide and the oxygen gases to the patient for treatment of at least one of pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD), pulmonary hypertension as pulmonary arterial hypertension (PAH), pulmonary hypertension secondary to idiopathic pulmonary fibrosis (IPF), and pulmonary hypertension secondary to sarcoidosis.

7. The nasal cannula of claim 1 , wherein the first lumen is six feet to eight feet in length having an inner diameter of 0.01 inches to 0.10 inches.

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

(

cc

)

(

mil

)

(

24

hrs

)

(

100

in

2

)

(

ATM

)

and

10

(

cc

)

(

mil

)

(

24

hrs

)

(

100

in

2

)

(

ATM

)

.

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

10. The nasal cannula of claim 1 , wherein the cannula nosepiece is further comprising a flexible support bridge that cushions the patient's the nasal septum.

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

a first lumen and a second lumen:

the first lumen connected to a nitric oxide source and being a combined first therapeutic gas and triggering lumen for both delivering a first therapeutic gas comprising nitric oxide to a patient and triggering, and

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

the first lumen and the second lumen aggregating at a cannula nosepiece, the cannula nosepiece having separate flow paths to the patient for (i) the combined first therapeutic gas and triggering lumen and (ii) the second therapeutic gas lumen such that the first therapeutic gas and the second therapeutic gas do not mix in the cannula nosepiece;

the combined first therapeutic gas and triggering lumen having an inner diameter that is smaller than an inner diameter of the second therapeutic gas lumen; and

the inner diameter of the combined first therapeutic gas and triggering lumen being larger than an inner diameter of the flow path for the combined first therapeutic gas and triggering lumen at the cannula nosepiece.

12. The nasal cannula of claim 11 , wherein the flow path for the combined first therapeutic gas and triggering lumen at the cannula nosepiece comprises a first prong, a second prong and a backplane, with the first prong being in fluid communication with the second prong via the backplane and the total volume of the first prong, the second prong and the backplane being less than 0.035 mL.

13. 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.

14. The nasal cannula of claim 11 , wherein the nasal cannula reduces delivery of nitrogen dioxide to the patient.

15. The nasal cannula of claim 11 , wherein the nasal cannula delivers one or more of the first and second therapeutic gases to the patient for treatment of pulmonary hypertension.

16. The nasal cannula of claim 15 , wherein the nasal cannula delivers one or more of the first and second therapeutic gases to the patient for treatment of at least one of pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD), pulmonary hypertension as pulmonary arterial hypertension (PAH), pulmonary hypertension secondary to idiopathic pulmonary fibrosis (IPF), and pulmonary hypertension secondary to sarcoidosis.

17. The nasal cannula of claim 11 , wherein the combined first therapeutic gas and triggering lumen is six feet to eight feet in length having an inner diameter of 0.01 inches to 0.10 inches.

Assignments (13)
SECURITY INTEREST Recorded Oct 28, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 073375/0395 →
CHANGE OF NAME Recorded Aug 16, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 072477/0834 →
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 →
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 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
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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
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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.)
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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
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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
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