US5922610A
Expired / Lapsed
US
⏱️ 0.0 years remaining
System to be used for the determination of no levels in exhaled air and diagnostic methods for disorders related to abnormal no levels
Assignee: Niox AB
•
Filing: 1994-07-04
•
Granted: 1999-07-13
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Expires: 2014-07-04
Abstract
Abstract The present invention is drawn to a system to be used for measuring NO levels in exhaled breathing air. The system comprises: (i) a face mask that tightly covers the nose and/or mouth of the individual that the mask is intended to be used on; (ii) an inlet unit for inhaled breathing air, (iii) an outlet unit for exhaled breathing air, (iv) a non-rebreathing valve through which inhaled and exhaled breathing air, respectively, passes, and (v) a measuring unit for NO connected to the outlet unit. The present invention furthers encompasses a method for the diagnosis in mammals of inflammatory conditions in the airways. The characteristic feature is that nitric oxide NO is measured in exhaled breathing air and a found abnormal level is taken as an indication of an inflammatory condition in the airways.
Inventors
- 👤 Kjell Alving
- 👤 Edward Weitzberg
- 👤 Jan Lundberg
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-27 19:11
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/483; G01N33/497; G01N29/00; G01N29/02; G01N29/22; G01N29/222; G01N33/0004; G01N33/0009; G01N33/0026; G01N33/0027; G01N33/0036; G01N33/0037; G01N2291/00; G01N2291/02; G01N2291/021; G01N2291/0215; G01N2291/028; G01N2291/02845; G01N2291/04; G01N2291/042; G01N2291/0422; G01N2291/0427; Y; Y02; Y02A; Y02A50/00; Y02A50/20; Y10; Y10T; Y10T436/00; Y10T436/17; Y10T436/177692; Y10T436/25; Y10T436/25875
Claims Analysis
Total Claims: 54
Claim 1
Independent Claim
144 words
A system for separate measurement of endogenously produced NO in nasally or orally exhaled air, comprising: (i) a face mask comprising a mouth piece and/or a nose piece, and which face mask covers the nose and/or mouth of the individual that the mask is intended to be used on; (ii) an inlet unit for inhaled breathing air connected to one of said mouth piece or said nose piece; (iii) an outlet unit for exhaled breathing air connected to one of said mouth piece or said nose piece; (iv) a non-rebreathing valve connecting said inlet and outlet units, through which inhaled and exhaled breathing air, respectively, passes; (v) a flow regulator, through which the exhaled air passes; and (vi) a measuring unit for endogenously produced NO connected to said outlet unit for measuring endogenously produced NO in nasally exhaled air or in orally exhaled air.
Claim 2
Independent Claim
144 words
A system for separate measurement of endogenously produced NO in nasally or orally exhaled air, comprising: (i) a face mask comprising a mouth piece and/or a nose piece, and which face mask covers the nose and/or mouth of the individual that the mask is intended to be used on; (ii) an inlet unit for inhaled breathing air connected to one of said mouth piece or said nose piece; (iii) an outlet unit for exhaled breathing air connected to one of said mouth piece or said nose piece; (iv) a non-rebreathing valve connecting said inlet and outlet units, through which inhaled and exhaled breathing air, respectively, passes; (v) a flow regulator, through which the exhaled air passes; and (vi) a measuring unit for endogenously produced NO connected to said outlet unit for measuring endogenously produced NO in nasally exhaled air or in orally exhaled air.
Claim 3
Dependent Claim
37 words
The system according to claim 1, wherein said inlet unit for inhaled breathing air comprises tubing having an opening to ambient air, said tubing being equipped with a filter for removal of NO present in ambient air.
Claim 4
Dependent Claim
30 words
The system according to claim 1, wherein said inlet unit for inhaled breathing air comprises tubing connected to a pressurized container for breathing air, which contains non-significant levels of NO.
Claim 5
Dependent Claim
23 words
The system according to claim 3, wherein an elastic reservoir is connected to the tubing between the pressurized container and the non-rebreathing valve.
Claim 6
Independent Claim
40 words
The system according to any one of claims 2-4, wherein said outlet unit has cubing for exhaled breathing air comprising a T-connection for diverting sample flow air, which is a cart of the exhaled breathing air to the measuring unit.
Claim 7
Dependent Claim
41 words
The system according to claim 5, wherein said sample air flow is less than an average breathing flow rate (minute volume) of the individual to whom the system is intended to be applied so that contamination by ambient air is avoided.
Claim 8
Independent Claim
89 words
The system according to any one of claims 2-4, wherein at least one filter selected from the group consisting of: (i) a filter for drying exhaled air; (ii) a filter for the removal of CO 2 in exhaled breathing air; and (iii) a particle filter is connected to the tubing or situated in the outlet unit or integrated with the measuring unit, with the provision that the filter or filters are so placed that air targeting the detector will pass said at least one filter before entering the detector.
Claim 9
Independent Claim
62 words
The system according to any one of claims 2-4 further comprising at least one device selected from the group consisting of: (i) a flow meter; and (ii) an outlet valve preventing (a) the build up of pressure in the tubing for inhaled breathing air, and (b) the leakage of air from the inlet unit to the outlet unit via the non-rebreathing valve.
Claim 10
Independent Claim
102 words
A system for measurement of NO in exhaled air, comprising: (i) a face mask that covers the nose and/or mouth of the individual that the mask is intended to be used on; (ii) a nasal or oral inlet unit for inhaled breathing air; (iii) a nasal or oral outlet unit for exhaled breathing air; wherein if said inlet unit is nasal, said outlet unit is nasal, and if said inlet unit is oral, said outlet unit is oral; (iv) a non-rebreathing valve through which inhaled and exhaled breathing air passes; and (v) a measuring unit for NO connected to said outlet unit.
Claim 11
Independent Claim
102 words
A system for measurement of NO in exhaled air, comprising: (i) a face mask that covers the nose and/or mouth of the individual that the mask is intended to be used on; (ii) a nasal or oral inlet unit for inhaled breathing air; (iii) a nasal or oral outlet unit for exhaled breathing air; wherein if said inlet unit is nasal, said outlet unit is nasal, and if said inlet unit is oral, said outlet unit is oral; (iv) a non-rebreathing valve through which inhaled and exhaled breathing air passes; and (v) a measuring unit for NO connected to said outlet unit.
Claim 12
Independent Claim
38 words
A method for diagnosis of inflammatory conditions in airways of humans, comprising: separately measuring endogenously produced NO in nasally exhaled air or in orally exhaled air with a system according to any one of claims 2-4 and 9.
Claim 13
Independent Claim
72 words
A method for diagnosis of inflammatory conditions in the airways of humans, comprising: measuring endogenously produced NO in nasally exhaled air to obtain a measured value for endogenously produced NO in said nasally exhaled air; comparing the measured value against a reference value based on values typical for healthy individuals; and diagnosing a level higher than values typical for healthy individuals as an indication of an inflammatory condition in the upper airways.
Claim 14
Independent Claim
72 words
A method for diagnosis of inflammatory conditions in the airways of humans, comprising: measuring endogenously produced NO in nasally exhaled air to obtain a measured value for endogenously produced NO in said nasally exhaled air; comparing the measured value against a reference value based on values typical for healthy individuals; and diagnosing a level higher than values typical for healthy individuals as an indication of an inflammatory condition in the upper airways.
Claim 15
Dependent Claim
12 words
The method according to claim 11, wherein said inflammatory condition is rhinitis.
Claim 16
Independent Claim
74 words
A method for diagnosis of inflammatory conditions in airways of humans, comprising: measuring the level of NO in nasally exhaled air to obtain a measured value for endogenously produced NO in said nasally exhaled air; and comparing the measured value against a reference value based an values typical for healthy individuals, wherein a level lower than values typical for healthy individuals is taken as an indication of an acute inflammation in the upper airways.
Claim 17
Independent Claim
74 words
A method for diagnosis of inflammatory conditions in airways of humans, comprising: measuring the level of NO in nasally exhaled air to obtain a measured value for endogenously produced NO in said nasally exhaled air; and comparing the measured value against a reference value based an values typical for healthy individuals, wherein a level lower than values typical for healthy individuals is taken as an indication of an acute inflammation in the upper airways.
Claim 18
Dependent Claim
19 words
The method according to claim 13, further comprising diagnosing an airway epithelial disease or increased susceptibility for developing sinusitis.
Claim 19
Dependent Claim
12 words
The method of claim 14, wherein said epithelial disease is Kartagener's syndrome.
Claim 20
Independent Claim
88 words
A method for diagnosis of inflammatory conditions in an airway of a human having a mouth, a nasal cavity, an upper airway and a lower airway, comprising: inhaling through the mouth of said human when an indication of the condition of the lower airways is desired and determining the level of NO in orally exhaled air, and when an indication of thc condition of the upper airways is desired, determining the level of NO in nasally exhaled air or in an air sample taken from the nasal cavity.
Claim 21
Independent Claim
88 words
A method for diagnosis of inflammatory conditions in an airway of a human having a mouth, a nasal cavity, an upper airway and a lower airway, comprising: inhaling through the mouth of said human when an indication of the condition of the lower airways is desired and determining the level of NO in orally exhaled air, and when an indication of thc condition of the upper airways is desired, determining the level of NO in nasally exhaled air or in an air sample taken from the nasal cavity.
Claim 22
Independent Claim
67 words
A method for diagnosis of inflammatory conditions in upper airways of a human having a mouth, a nasal cavity, and upper airway and a lower airway, comprising: taking a gas sample from the nasal cavity; and determining the level of NO in said sample, wherein a level higher than values typical for healthy individuals is taken as an indication of an inflammatory condition in the upper airways.
Claim 23
Independent Claim
67 words
A method for diagnosis of inflammatory conditions in upper airways of a human having a mouth, a nasal cavity, and upper airway and a lower airway, comprising: taking a gas sample from the nasal cavity; and determining the level of NO in said sample, wherein a level higher than values typical for healthy individuals is taken as an indication of an inflammatory condition in the upper airways.
Claim 24
Independent Claim
67 words
A method for diagnosis of inflammatory conditions in upper airways of a human having a mouth, a nasal cavity, and upper airway and a lower airway, comprising: taking an air sample from the nasal cavity; and determining the level of NO in said sample wherein a level lower than values typical for healthy individuals is taken as an indication of an acute inflammation in the upper airways.
Claim 25
Independent Claim
67 words
A method for diagnosis of inflammatory conditions in upper airways of a human having a mouth, a nasal cavity, and upper airway and a lower airway, comprising: taking an air sample from the nasal cavity; and determining the level of NO in said sample wherein a level lower than values typical for healthy individuals is taken as an indication of an acute inflammation in the upper airways.
Claim 26
Dependent Claim
13 words
The method according to claim 16, for the diagnosis of airway epithelial diseases.
Claim 27
Independent Claim
38 words
The method according to any one of claims 17-19, wherein the gas sample taken from the nasal cavity is a sample aspirated from the nasal cavity or a sample obtained by flushing the nasal cavity with NO-free air.
Claim 28
Independent Claim
59 words
A method for the diagnosis of inflammatory conditions in airways of a human patient having a nasal cavity, comprising: taking a gas sample from the nasal cavity of the patient while the patient is holding his/her breath; and determining the level of NO in said gas sample in order to perform the diagnosis of inflammatory conditions in the airways.
Claim 29
Independent Claim
59 words
A method for the diagnosis of inflammatory conditions in airways of a human patient having a nasal cavity, comprising: taking a gas sample from the nasal cavity of the patient while the patient is holding his/her breath; and determining the level of NO in said gas sample in order to perform the diagnosis of inflammatory conditions in the airways.
Claim 30
Independent Claim
52 words
A method for diagnosis of inflammatory conditions in airways of a human having a nasal cavity, comprising: exhaling orally against a flow-regulator while a sample is taken from the nasal cavity; and determining the level of NO in said sample in order to perform the diagnosis of inflammatory conditions in the airways.
Claim 31
Independent Claim
52 words
A method for diagnosis of inflammatory conditions in airways of a human having a nasal cavity, comprising: exhaling orally against a flow-regulator while a sample is taken from the nasal cavity; and determining the level of NO in said sample in order to perform the diagnosis of inflammatory conditions in the airways.
Claim 32
Independent Claim
71 words
A method for diagnosis of inflammatory conditions in the airways of a human having lower and upper airways, comprising: determining the level of NO in nasally exhaled air; determining the level of NO in orally exhaled air; comparing said level of NO determined in nasally exhaled air to the level of NO determined in orally exhaled air; and determining the relative contribution of NO from the lower and upper airways, respectively.
Claim 33
Independent Claim
71 words
A method for diagnosis of inflammatory conditions in the airways of a human having lower and upper airways, comprising: determining the level of NO in nasally exhaled air; determining the level of NO in orally exhaled air; comparing said level of NO determined in nasally exhaled air to the level of NO determined in orally exhaled air; and determining the relative contribution of NO from the lower and upper airways, respectively.
Claim 34
Independent Claim
41 words
The method according to any one of claims 11-16, comprising determining the level of NO in nasally exhales air, determining the level of NO in orally exhaled air and determining relative contributions of NO from the lower and upper airways, respectively.
Claim 35
Independent Claim
83 words
A method for diagnosis of inflammatory conditions in the airways of humans, comprising: passing exhaled breathing air, which is nasally exhaled air or which is orally exhaled air, through at least one filter selected from the group consisting of: (i) a filter for drying exhaled air; (ii) a filter for the removal of CO 2 in exhaled breathing air; and iii) a particle filter; and thereafter measuring the amount of NO in said exhaled breathing air which has been passed through said filter.
Claim 36
Independent Claim
83 words
A method for diagnosis of inflammatory conditions in the airways of humans, comprising: passing exhaled breathing air, which is nasally exhaled air or which is orally exhaled air, through at least one filter selected from the group consisting of: (i) a filter for drying exhaled air; (ii) a filter for the removal of CO 2 in exhaled breathing air; and iii) a particle filter; and thereafter measuring the amount of NO in said exhaled breathing air which has been passed through said filter.
Claim 37
Independent Claim
48 words
A method for diagnosis of gastro-esophageal disorders in humans, comprising: determining the level of NO in regurgitated air and taking an altered level of NO in relation to a level typical for a healthy population as an indication of a disease associated with altered levels of NO production.
Claim 38
Independent Claim
48 words
A method for diagnosis of gastro-esophageal disorders in humans, comprising: determining the level of NO in regurgitated air and taking an altered level of NO in relation to a level typical for a healthy population as an indication of a disease associated with altered levels of NO production.
Claim 39
Independent Claim
49 words
A method for diagnosis of gastric reflux in humans, comprising; determining the level of NO in breathing air, over a predetermined period of time, wherein an occurrence of peak NO levels, compared to a baseline level during said period of tire, is taken as an indication of gastric reflux.
Claim 40
Independent Claim
49 words
A method for diagnosis of gastric reflux in humans, comprising; determining the level of NO in breathing air, over a predetermined period of time, wherein an occurrence of peak NO levels, compared to a baseline level during said period of tire, is taken as an indication of gastric reflux.
Claim 41
Independent Claim
37 words
A method for monitoring effects of treatment with drugs inhibiting gastric acid secretion, comprising: administering a drug to a subject; and determining the level of NO in regurgitated air of said subject after administration of said drug.
Claim 42
Independent Claim
37 words
A method for monitoring effects of treatment with drugs inhibiting gastric acid secretion, comprising: administering a drug to a subject; and determining the level of NO in regurgitated air of said subject after administration of said drug.
Claim 43
Dependent Claim
16 words
The method according to claim 17, wherein said inflammatory condition in the upper airways is rhinitis.
Claim 44
Dependent Claim
20 words
The method according to claim 19, wherein the airway epithelial disease is Kartagener's syndrome or increased susceptibility for developing sinusitis.
Claim 45
Dependent Claim
34 words
The method according to claim 27, which further comprises the steps of: subjecting said human to fasting conditions to establish said baseline level; and administering a substance which affects gastric reflux to said human.
Claim 46
Dependent Claim
15 words
The method according to claim 31, wherein said substance which affects gastric reflux is food.
Claim 47
Dependent Claim
16 words
The method according to claim 32, wherein said substance which affects gastric reflux is a drug.
Claim 48
Dependent Claim
28 words
The system according to claim 1, wherein said inlet unit and said outlet unit are connected to the same one of said mouth piece and said nose piece.
Claim 49
Independent Claim
108 words
A method for diagnosis of inflammatory conditions in lower airways of humans, comprising: causing a patient to inhale orally through the mouth and thereafter causing said patient to exhale orally through the mouth; and measuring endogenously produced NO in said orally exhaled air with a system comprising: (i) a mouth piece; (ii) an inlet unit for inhaled breathing air connected to said (iii) an outlet unit for exhaled breathing air connected to said mouth piece; (iv) a flow regulator, through which the exhaled air passes; and (v) a measuring unit for endogenously produced NO connected to said outlet unit for measuring endogenously produced NO in orally exhaled air.
Claim 50
Independent Claim
108 words
A method for diagnosis of inflammatory conditions in lower airways of humans, comprising: causing a patient to inhale orally through the mouth and thereafter causing said patient to exhale orally through the mouth; and measuring endogenously produced NO in said orally exhaled air with a system comprising: (i) a mouth piece; (ii) an inlet unit for inhaled breathing air connected to said (iii) an outlet unit for exhaled breathing air connected to said mouth piece; (iv) a flow regulator, through which the exhaled air passes; and (v) a measuring unit for endogenously produced NO connected to said outlet unit for measuring endogenously produced NO in orally exhaled air.
Claim 51
Dependent Claim
28 words
The method of claim 35, wherein said system further comprises a non-rebreathing valve connecting said inlet and outlet units through which inhaled and exhaled breathing air, respectively, passes.
Claim 52
Independent Claim
84 words
A system for diagnosis of inflammatory conditions in lower airways of humans, comprising: (i) a mouth piece through which a human can inhale and exhale; (ii) an inlet unit for inhaled breathing air connected to said mouth piece, (iii) an outlet unit for exhaled breathing air connected to said mouth piece; (iv) a flow regulator, through which the exhaled air passes; and (v) a measuring unit for endogenously produced NO connected to said outlet unit for measuring endogenously produced NO in orally exhaled air.
Claim 53
Independent Claim
84 words
A system for diagnosis of inflammatory conditions in lower airways of humans, comprising: (i) a mouth piece through which a human can inhale and exhale; (ii) an inlet unit for inhaled breathing air connected to said mouth piece, (iii) an outlet unit for exhaled breathing air connected to said mouth piece; (iv) a flow regulator, through which the exhaled air passes; and (v) a measuring unit for endogenously produced NO connected to said outlet unit for measuring endogenously produced NO in orally exhaled air.
Claim 54
Dependent Claim
26 words
The system of claim 37, which further comprises a non-rebreathing valve connecting said inlet and outlet units through which inhaled and exhaled breathing air, respectively, passes.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2002-07-12 | 2003-01-11 | 2003-07-13 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-07-12 | 2007-01-11 | 2007-07-13 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-07-12 | 2011-01-11 | 2011-07-13 | $7700.00 | Window Closed / Lapsed |