Cannula for minimizing dilution of dosing during nitric oxide delivery

• US 10,130,783 B2
• Filed: 05/07/2015
• Issued: 11/20/2018
• Est. Priority Date: 12/04/2012
• Status: Active Grant

• Current Assignee: Mallinckrodt Hospital Products IP Ltd. (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): Tsai, Michael
• Application Number:
  US14/706,449
• Publication Number:
  US 20150238720A1
• Time in Patent Office: 1,293 Days
• 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 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

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.