Cannula for minimizing dilution of dosing during nitric oxide delivery

• US 9,795,756 B2
• Filed: 12/04/2013
• Issued: 10/24/2017
• 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: Mallinckrodt Hospital Products IP Ltd. (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): Stuart, Colin W
• Application Number:
  US14/096,548
• Publication Number:
  US 20140166009A1
• Time in Patent Office: 1,420 Days
• Field of Search: 12820718
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• 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 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2206/10 Flow characteristics
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production

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

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

a nitric oxide source;

an oxygen source;

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 comprising nitric oxide from the nitric oxide source to the patient,

the second lumen being a triggering lumen, and

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

a cannula nosepiece 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 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.

2. The nasal cannula of claim 1, 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.

3. 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 one or more of chronic obstructive pulmonary disease (COPD) and pulmonary arterial hypertension (PAH).

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 both of the second therapeutic gas lumen for delivering oxygen and the triggering lumen.

5. The nasal cannula of claim 1, wherein one or more of (i) the first therapeutic gas is nitric oxide and the first therapeutic gas lumen for delivering nitric oxide has an inner diameter of about 0.01 inches to about 0.08 inches and (ii) the triggering lumen has an inner diameter of about 0.05 inches to about 0.12 inches.

6. The nasal cannula of claim 1, wherein the nasal cannula is further comprising one or more of (i) a wall material having a low oxygen diffusion coefficient and (ii) at least one valve in fluid communication with the first therapeutic gas lumen.

7. 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 is adapted to deliver the first therapeutic gas to one nostril of the patient and the fourth lumen is adapted to deliver the first therapeutic gas to another nostril of the patient.

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

a nitric oxide source;

an oxygen source;

a first lumen and a second lumen;

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

the second lumen being a second therapeutic gas lumen for delivering a second therapeutic gas comprising oxygen from the oxygen source to the patient,

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

a cannula nosepiece allowing separate flow paths to the patient for each of (i) the combined first therapeutic gas and triggering lumen and (ii) the second therapeutic gas lumen; and

wherein the cannula nosepiece comprises a nitric oxide flow path having an inner diameter that is smaller than an inner diameter of the combined first therapeutic gas and triggering lumen.

9. The nasal cannula of claim 8, 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.

10. The nasal cannula of claim 8, wherein the nasal cannula delivers one or more of the first and second therapeutic gases to the patient for treatment of one or more of chronic obstructive pulmonary disease (COPD) and pulmonary arterial hypertension (PAH).

11. The nasal cannula of claim 8, wherein one or more of (i) the first therapeutic gas is nitric oxide and the combined first therapeutic gas and triggering lumen has an inner diameter of about 0.01 inches to about 0.08 inches and (ii) the first therapeutic gas is nitric oxide and the cannula nosepiece comprises a combined nitric oxide and triggering flow path having an inner diameter that is smaller than an inner diameter of the combined first therapeutic gas and triggering lumen.

12. The nasal cannula of claim 8, wherein the nasal cannula is further comprising one or more of (i) a wall material having a low oxygen diffusion coefficient and (ii) at least one valve in fluid communication with the first therapeutic gas lumen.

13. 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, wherein the pulse is administered through a nasal cannula comprising;

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

the first lumen being a first therapeutic gas lumen which delivers 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 which delivers a gas comprising oxygen to the patient; and

a cannula nosepiece 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 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.

14. The method of claim 13, 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.

15. The method of claim 13, wherein the nitric oxide flow path of the cannula nosepiece has a volume that is less than 10% of the volume of the pulse of the gas comprising nitric oxide.

16. The method of claim 13, wherein the nasal cannula comprises one or more of (i) a wall material having a low oxygen diffusion coefficient and (ii) at least one valve in fluid communication with the first therapeutic gas lumen.

17. The method of claim 13, wherein the nasal cannula is further comprising a fourth lumen:

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

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

18. 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, wherein the pulse is administered through a nasal cannula comprising;

a first lumen and a second lumen;

the first lumen being a combined first therapeutic gas and triggering lumen which both delivers a gas comprising nitric oxide to the patient and triggers, and

the second lumen being a second therapeutic gas lumen which delivers a gas comprising oxygen to the patient; and

a cannula nosepiece allowing separate flow paths to the patient for each of (i) the combined first therapeutic gas and triggering lumen and (ii) the second therapeutic gas lumen; and

wherein the cannula nosepiece comprising a nitric oxide flow path having an inner diameter that is smaller than an inner diameter of the combined first therapeutic gas and triggering lumen.

19. The method of claim 18, 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.

20. The method of claim 18, wherein the nitric oxide flow path of the cannula nosepiece has a volume that is less than 10% of the volume of the pulse of the gas comprising nitric oxide.

21. The method of claim 18, wherein the nasal cannula comprises one or more of (i) a wall material having a low oxygen diffusion coefficient and (ii) at least one valve in fluid communication with the first therapeutic gas lumen.