# US 8,770,199 B2 · Cannula for minimizing dilution of dosing during nitric oxide delivery

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- Number: US 8,770,199 B2
- Document ID: US8770199B2
- Status: Granted
- Kind: B2
- Application number: 14/096,629
- Filed: 2013-12-04
- Published: 2014-06-05
- Granted: 2014-07-08
- Earliest claimed: 2012-12-04
- Assignees: INO Therapeutics LLC
- Applicants: INO Therapeutics LLC
- Inventors: Craig Flanagan; Simon Freed; John Klaus; Thomas Kohlmann; Martin D. Meglasson; Manesh Naidu; Parag Shah
- Web page: https://patentgrep.com/patent/US8770199B2

## CPC

- A61M 16/0677: {Gas-saving devices therefor}
- 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)}
- 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)}
- A61M 16/0672: {Nasal cannula assemblies for oxygen therapy}
- A61M 16/0875: {Connecting tubes}
- A61M 16/10: Preparation of respiratory gases or vapours
- A61M 16/1005: {with O2 features or with parameter measurement}
- A61M 16/104: {specially adapted for anaesthetics (A61M16/18 takes precedence)}
- A61M 16/122: {with dilution}
- A61M 16/125: {Diluting primary gas with ambient air}
- A61M 16/204: {used for inhalation control}
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61M 16/101: {using an oxygen concentrator}
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2016/0027: {pressure meter}
- A61M 2202/0208: Oxygen
- A61M 2202/0266: Nitrogen (N)
- A61M 2202/0275: Nitric oxide [NO]
- A61M 2202/0283: Nitrous oxide (N2O)
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/3303: Using a biosensor
- A61M 2205/3331: Pressure; Flow
- A61M 2205/75: with filters
- A61M 2210/0618: Nose
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

The nasal cannula of claim 1, wherein the cannula comprises a wall material having a low oxygen transmission rate that is between
0.001
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10
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.

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 1)

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.

### Claim 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.

### Claim 14 (depends on 13)

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.

### Claim 15 (depends on 13)

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.

### Claim 16 (depends on 13)

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.

### Claim 17 (depends on 13)

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.

### Claim 18 (depends on 13)

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.

### Claim 19 (depends on 13)

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.

### Claim 20 (depends on 13)

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
)
(
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⁢
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)
⁢
(
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⁢
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in
2
)
⁢
(
ATM
)
and
10
⁢
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(
24
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hrs
)
⁢
(
100
⁢
⁢
in
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)
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(
ATM
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.

### Claim 21 (depends on 13)

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.

### Claim 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.

### Claim 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.

### Claim 24 (depends on 23)

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.

### Claim 25 (depends on 23)

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.

### Claim 26 (depends on 23)

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.

### Claim 27 (depends on 23)

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
)
.

### Claim 28 (depends on 23)

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.