# US 11,534,082 B2 · System for collecting exhaled particles

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- Number: US 11,534,082 B2
- Document ID: US11534082B2
- Status: Granted
- Kind: B2
- Application number: 16/628,844
- Filed: 2018-07-04
- Published: 2020-07-16
- Granted: 2022-12-27
- Earliest claimed: 2017-07-10
- Assignees: Pexa AB
- Applicants: Pexa AB
- Inventors: Svante Höjer
- Web page: https://patentgrep.com/patent/US11534082B2

## CPC

- A61B 5/097: Devices for facilitating collection of breath or for directing breath into or through measuring devices
- A61B 5/082: {Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath (A61B5/083, A61B5/091 take precedence)}
- G01N 33/497: of gaseous biological material, e.g. breath
- A61B 2560/02: Operational features
- A61B 2560/04: Constructional details of apparatus
- G01N 33/4975: {other than oxygen, carbon dioxide or alcohol, e.g. organic vapours}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The disclosure pertains to a system 100 and method for collecting and measuring particles in exhaled air. The system 100 is arranged to allow for examination of the full or substantially the full volume of each exhalation of a subject.

## Claims

### Claim 1

A system for collecting exhaled particles, said system comprising:
a) a reservoir having a first opening and a second opening;
b) a two-way mouthpiece and a one-way valve configured to open to permit the user to inhale through said mouthpiece via said one-way valve and to close thereafter, thereby preventing outside air from entering the system when the user exhales through said mouthpiece;
c) an inertial impactor having an inlet and an outlet, said impactor being arranged to pass a gas stream comprising particles between said inlet and said outlet, said inlet of said inertial impactor being connected to said first opening of said reservoir, and said outlet of said inertial impactor being connected to said second opening of said reservoir;
d) a pump having an inlet and an outlet, said pump being arranged to maintain a constant gas stream flow through said impactor;
e) a first valve disposed between said mouthpiece and said inertial impactor; and
f) a further valve disposed between said first valve and said inertial impactor and configured to allow exhaled air to enter said impactor and/or said reservoir, or to be let out of the system, wherein
said first opening of said reservoir is connected to said mouthpiece via said first valve and said further valve,
said pump is located downstream of said impactor,
said second opening of said reservoir is connected to said outlet of said pump, and
the system is configured to collect exhaled particles in the exhaled air without permitting outside air to be added to the reservoir.

### Claim 2 (depends on 1)

The system according to claim 1 further comprising a second valve, wherein
said second opening of said reservoir is connected to said outlet of said pump upstream of said second valve.

### Claim 3 (depends on 1)

The system according to claim 1, further comprising a first flow meter arranged to measure said gas stream flow through said impactor and said pump.

### Claim 4 (depends on 3)

The system according to claim 3, wherein said first flow meter is arranged downstream of said pump.

### Claim 5 (depends on 3)

The system according to claim 3, further comprising a second flow meter arranged to measure a total volume of an exhalation by a subject.

### Claim 6 (depends on 1)

The system according to claim 1, further comprising a particle counter.

### Claim 7 (depends on 1)

The system according to claim 1, wherein said mouthpiece, said impactor and/or said reservoir are thermostatted.

### Claim 8 (depends on 1)

The system according to claim 1, wherein said further valve is arranged to be operated manually or is a one-way valve.

### Claim 9 (depends on 1)

The system according to claim 1, further comprising a line for gas including a particle filter and another one-way valve.

### Claim 10 (depends on 9)

The system according to claim 9, wherein the line for gas further includes a flow meter.

### Claim 11 (depends on 1)

A method for detecting a biomarker associated with a medical condition in a patient, comprising the steps of
collecting exhaled particles from the patient using the system of claim 1; and
assaying the particles to detect the presence of the biomarker.

### Claim 12 (depends on 11)

The method according to claim 11, wherein said biomarker is selected from the group consisting of proteins, phospholipids, bacteria, RNA, and DNA.

### Claim 13 (depends on 11)

The method according to claim 11, wherein said medical condition is selected from the group consisting of asthma bronchiale, cystic fibrosis, chronic obstructive pulmonary disease (COPD), interstitial lung-disease, sarcoidosis, pulmonary engagement in systemic disease, pulmonary infections, bacterial colonization, viral infections, heart failure, hypercholesterolemia, diabetes, metabolic syndrome, a condition associated with organ transplant rejection, and increased genetic susceptibility to disease or exposure.

### Claim 14 (depends on 13)

The method according to claim 13, wherein the pulmonary infection is pneumonia.
