IP Library Granted Patent US 8,770,199
Granted Patent B2
US 8,770,199 · App. 14/096,629 · Granted Jul 8, 2014

Cannula for minimizing dilution of dosing during nitric oxide delivery

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Quick Facts
Patent No.
US 8,770,199
App. No.
14/096,629
Granted
Jul 8, 2014
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 (228)

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:

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

the second lumen being a triggering lumen, and

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

a cannula nosepiece aggregating, and allowing 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; and

wherein the first lumen has an inner diameter that is smaller than an inner diameters of the second lumen and third 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 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 nasal cannula delivers one or more of the first and second therapeutic gases to the patient for treatment of pulmonary hypertension.

5. The nasal cannula of claim 1 , 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.

6. The nasal cannula of claim 1 , wherein the first therapeutic gas is nitric oxide and the second therapeutic gas is oxygen.

7. 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.

8. The nasal cannula of claim 1 , wherein the first therapeutic gas is nitric oxide.

9. 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 defined by the region extending between exits of a first and second nasal cannula nare that is less than about 10% of a minimum pulse volume of the pulse of nitric oxide.

10. 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

)

.

11. 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.

12. 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.

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

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

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

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

the third lumen being 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 (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.

14. The nasal cannula of claim 13 , 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.

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

16. The nasal cannula of claim 13 , wherein the nasal cannula delivers one or more of the first and second therapeutic gases to the patient for treatment of pulmonary hypertension.

17. The nasal cannula of claim 13 , 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.

18. The nasal cannula of claim 13 , 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.

19. The nasal cannula of claim 13 , wherein the first therapeutic gas is nitric oxide and the cannula nosepiece comprises a nitric oxide flow path having a volume defined by the region extending between exits of a first and second nasal cannula nare that is less than about 10% of a minimum pulse volume of the pulse of nitric oxide.

20. The nasal cannula of claim 13 , 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

)

.

21. The nasal cannula of claim 13 , 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.

22. A nasal cannula for therapeutic gas delivered to a patient, comprising:

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

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

the second lumen being a triggering lumen, and

the third lumen being a second therapeutic gas lumen for delivering one or more of oxygen gas and air 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;

the flow path for the first therapeutic gas lumen for delivering nitric oxide to the patient having a volume defined by the region extending between exits of a first and second nasal cannula nare at the cannula nosepiece that is less than about 10% of a minimum pulse volume of the pulse of nitric oxide;

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

the first therapeutic gas lumen having an inner diameter that is larger than an inner diameter of the flow path for the first therapeutic gas lumen at the cannula nosepiece.

23. A method for treating pulmonary hypertension, comprising:

administering nitric oxide gas to a patient through a nasal cannula, 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 nitric oxide gas to a patient,

the second lumen being a triggering lumen for sensing the onset of inspiration or a change in pressure, and

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

a cannula nosepiece aggregating, and allowing 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;

wherein the first lumen has an inner diameter that is smaller than an inner diameters of the second lumen and third lumen but larger than an inner diameter of the flow path for the first lumen at the cannula nosepiece.

24. The method of claim 23 , wherein the nasal cannula one or more of (i) reduces dilution of one or more of the first and second therapeutic gases delivered to the patient and (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.

25. The method of claim 23 , wherein the nasal cannula at least one of inhibits mixing of nitric oxide and oxygen and reduces delivery of nitrogen dioxide to the patient.

26. The method of claim 23 , wherein the cannula nosepiece comprises a nitric oxide flow path having a volume defined by the region extending between exits of a first and second nasal cannula nare that is less than about 10% of a minimum pulse volume of the pulse of nitric oxide.

27. The method of claim 23 , 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

)

.

28. The method of claim 23 , 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 that cushions the patient's nasal septum.

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SECURITY INTEREST Recorded Oct 28, 2025
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To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
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From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
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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
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