Cannula for minimizing dilution of dosing during nitric oxide delivery

• US 9,550,039 B2
• Filed: 06/23/2014
• Issued: 01/24/2017
• Est. Priority Date: 12/04/2012
• Status: Active Grant

• Current Assignee: Mallinckrodt Pharma Ip Trading DAC (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): MATTER, KRISTEN CLARETTE
• Application Number:
  US14/312,003
• Publication Number:
  US 20140299129A1
• Time in Patent Office: 946 Days
• US Class Current: 1/1
• 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, 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 comprising nitric oxide 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 comprising oxygen to the patient; and

a cannula nosepiece allowing separate flow paths to the patient for (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 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 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.

7. The nasal cannula of claim 1, wherein the cannula nosepiece comprises a nitric oxide flow path having a volume that is less than about 25% of a minimum pulse volume of the pulse of nitric oxide.

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, 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.

10. 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.

11. 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 comprising nitric oxide 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 comprising oxygen 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.

12. 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.

13. The nasal cannula of claim 11, wherein the nasal cannula at least one of inhibits mixing of nitric oxide and oxygen and reduces delivery of nitrogen dioxide to the patient.

14. 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.

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 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.

16. The nasal cannula of claim 11, wherein 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.

17. The nasal cannula of claim 11, wherein the cannula nosepiece comprises a nitric oxide flow path having a volume that is less than about 25% of a minimum pulse volume of the pulse of nitric oxide.

18. The nasal cannula of claim 11, wherein the cannula comprises a wall material having a low oxygen transmission rate that is between