Cannula for minimizing dilution of dosing during nitric oxide delivery

• US 9,032,959 B2
• Filed: 12/04/2013
• Issued: 05/19/2015
• Est. Priority Date: 12/04/2012
• Status: Active Grant

• Current Assignee: Mallinckrodt Critical Care Finance Inc (Mallinckrodt plc), Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc), Therakos, Inc (Mallinckrodt plc)
• Original Assignee: INO Therapeutics LLC (Mallinckrodt plc)
• Inventors: Flanagan, Craig, Freed, Simon, Klaus, John, Kohlmann, Thomas, Meglasson, Martin D., Naidu, Manesh, Shah, Parag
• Primary Examiner(s): Yu, Justine
• Assistant Examiner(s): TSAI, MICHAEL JASPER
• Application Number:
  US14/096,910
• Publication Number:
  US 20140158121A1
• Time in Patent Office: 531 Days
• Field of Search: 128/200.24, 128/203.12, 128/203.22, 128/203.24, 128/204.18, 128/206.11, 128/207.13, 128/207.18
• US Class Current: 128/207.18
• CPC Class Codes: A61M 16/009 Removing used or expired gases or anaesthetic vapours filtering, sterilising or disinfecting the exhaust air in drainage systems A61M1/784; bacterial filters in the expiratory path A61M16/1065
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0672 Nasal cannula assemblies for oxygen therapy
• CPC Class Codes: A61M 16/0677 Gas-saving devices therefor
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/1005 with O2 features or with parameter measurement
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/104 specially adapted for anaesthetics A61M16/18 takes precedence
• CPC Class Codes: A61M 16/122 with dilution
• CPC Class Codes: A61M 16/125 Diluting primary gas with ambient air
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0266 Nitrogen (N)
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2202/0283 Nitrous oxide (N2O)
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/75 : with filters
• CPC Class Codes: A61M 2210/0618 : Nose

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

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

a nitric oxide lumen and an oxygen lumen;

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

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

the nitric oxide lumen and the oxygen lumen aggregating at a cannula nosepiece, the cannula nosepiece having separate flow paths to the patient for (i) the nitric oxide lumen and (ii) the oxygen lumen such that the flow path for the first therapeutic gas delivers the first therapeutic gas to both a first nostril and a second nostril of a patient and the flow path for the second therapeutic gas delivers the second therapeutic gas to both the first and second nostrils of the patient without mixing the first therapeutic gas and the second therapeutic gas in the cannula nosepiece when connected to a first gas source comprising nitric oxide and a second gas source comprising oxygen; and

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

2. The nasal cannula of claim 1, wherein the flow path for the first therapeutic gas at the cannula nosepiece has a first cross-sectional area and the flow path for the second therapeutic gas at the cannula nosepiece has a second cross-sectional area, wherein the ratio of the square root of the second cross-sectional area to the square root of the first cross-sectional area is greater than 1.2:

1.

3. The nasal cannula of claim 1, wherein the flow path for the first therapeutic gas 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.

4. 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.

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

6. 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.

7. The nasal cannula of claim 6, 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.

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

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

10. The nasal cannula of claim 1, further comprising one or more of:

(i) at least one check valve in fluid communication with the nitric oxide lumen, (ii) a cannula key, and (iii) a scavenging material.

11. 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.

12. The nasal cannula of claim 1, wherein one or more of the nitric oxide lumen and the oxygen lumen further provides triggering.

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

a nitric oxide lumen and an oxygen lumen;

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

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

the nitric oxide lumen and the oxygen lumen aggregating at a cannula nosepiece, the cannula nosepiece having separate flow paths to the patient for (i) the nitric oxide lumen and (ii) the oxygen lumen when connected to a first gas source comprising nitric oxide and a second gas source comprising oxygen;

the nitric oxide lumen having an inner diameter that is smaller than an inner diameter of the oxygen lumen; and

wherein the flow path for the first therapeutic gas 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 inner diameter of the nitric oxide lumen being larger than an inner diameter of the flow path for the first therapeutic gas at the cannula nosepiece.

14. The nasal cannula of claim 13, wherein cannula nosepiece comprises a nitric oxide flow path having a volume that is less than 0.035 mL and the flow path for the first therapeutic gas delivers the first therapeutic gas to both a first nostril and a second nostril of a patient and the flow path for the second therapeutic gas delivers the second therapeutic gas to both the first and second nostrils of the patient without mixing the first therapeutic gas and the second therapeutic gas in the cannula nosepiece.

15. 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.

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

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 pulmonary hypertension.

18. The nasal cannula of claim 17, 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.

19. The nasal cannula of claim 13, wherein the nitric oxide lumen is six feet to eight feet in length having an inner diameter of 0.01 inches to 0.10 inches.

20. The nasal cannula of claim 13, wherein the cannula nosepiece comprises a nitric oxide flow path having an inner diameter that is smaller than an inner diameter of the nitric oxide lumen.

21. The nasal cannula of claim 13, wherein the cannula comprises a wall material having a low oxygen transmission rate that is between

22. The nasal cannula of claim 13, further comprising one or more of:

(i) at least one check valve in fluid communication with the nitric oxide lumen, (ii) a cannula key, and (iii) a scavenging material.

23. The nasal cannula of claim 13, wherein the cannula nosepiece is further comprising a flexible support bridge that cushions the patient'"'"'s the nasal septum.

24. The nasal cannula of claim 13, wherein one or more of the nitric oxide lumen and the oxygen lumen further provides triggering.

25. 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 being a first therapeutic gas lumen for delivering a first therapeutic gas comprising nitric oxide gas to a patient when connected to a first gas source comprising nitric oxide, and

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

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 first therapeutic gas lumen and (ii) the second therapeutic gas lumen;

wherein the flow path for the first therapeutic gas 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 flow path for the first therapeutic gas at the cannula nosepiece has a volume that is less than 0.035 mL;

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

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

26. The nasal cannula of claim 25, wherein one or more of the first lumen and the second lumen further provides triggering.

27. A method for treating pulmonary hypertension, the method comprising:

administering a pulse of nitric oxide gas to a patient through a nasal cannula, wherein the nasal cannula comprises;

a first lumen and a second lumen;

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

the second lumen being a second therapeutic gas lumen for delivering a second therapeutic gas comprising oxygen to the patient when connected to a second gas source comprising oxygen, and

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 first therapeutic gas lumen and (ii) the second therapeutic gas lumen;

the flow path for the first therapeutic gas at the cannula nosepiece comprising a first prong, a second prong and a backplane, with the first prong being in fluid communication with the second prong via the backplane;

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

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

28. The method of claim 27, 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.

29. The method of claim 27, wherein the nasal cannula at least one of inhibits mixing of nitric oxide and oxygen and reduces delivery of nitrogen dioxide to the patient.

30. The method of claim 27, wherein the flow path for the first therapeutic gas has a volume at the cannula nosepiece that is less than 10% of a volume of the pulse of nitric oxide.

31. The method of claim 27, wherein the nasal cannula comprises a wall material having a low oxygen transmission rate that is between

32. The method of claim 27, wherein the nasal cannula is 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 a flexible support bridge that cushions the patient'"'"'s nasal septum.

33. The method of claim 27, wherein one or more of the first lumen and the second lumen further provides triggering.