# US 2014/0194504 A1 · Diagnosis and treatment methods for entry of gastrointestinal contents into respiratory tract

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- Number: US 2014/0194504 A1
- Document ID: US20140194504A1
- Status: Published application
- Kind: A1
- Application number: 14/204,826
- Filed: 2014-03-11
- Published: 2014-07-10
- Earliest claimed: 2010-06-17
- Assignees: The Regents of the University of California; Aradigm Corporation
- Applicants: The Regents of the University Of California; Aradigm Corporation
- Inventors: Igor Gonda; Homer A. Boushey
- Web page: https://patentgrep.com/patent/US20140194504A1

## CPC

- A61K 31/352: condensed with carbocyclic rings, e.g. methantheline {(cannabinoids A61K31/658)}
- A61B 5/082: {Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath (A61B5/083, A61B5/091 take precedence)}
- A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06)
- A61B 5/14507: {specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045)}
- A61B 5/4211: {Diagnosing or evaluating reflux}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- A61B 5/14: {Devices for taking samples of blood (hypodermic syringes A61M5/00); Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood (measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06)}
- A61B 5/150015: {Source of blood}
- G01N 2800/06: Gastro-intestinal diseases
- Y10T 436/142222: Hetero-O [e.g., ascorbic acid, etc.]
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A method of diagnosing in a subject for the purpose of determining if the subject's gastrointestinal contents has entered the subject's respiratory tract. The qualitative analysis can be also expanded into quantitative analysis, enabling the estimation of either the concentration, or the amount, or both, of the gastrointestinal contents that entered the respiratory tract. The invention also provides methods of treatment based on the identification of aspiration using the methods of the invention.

## Claims

### Claim 1

A method of treating a subject suffering from entry of gastrointestinal fluid into
the respiratory tract, comprising:
orally administering to a subject a diagnostic formulation comprising a plurality of particles, wherein the particles comprise a biocompatible material that is not destroyed in the gastrointestinal or respiratory tracts and a detectable label;
allowing the formulation to remain in the subject over a period of time during which the subject would be expected to aspirate the formulation from the gastrointestinal tract into the respiratory tract;
accessing respiratory fluid from the subject;
analyzing the respiratory fluid to determine the concentration of label in the respiratory fluid;
identifying a concentration of label in the respiratory fluid indicative of an aspiration of gastrointestinal fluid into the respiratory tract requiring medical treatment; and
providing an intervention to prevent or reduce such aspirations in the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the biocompatible material comprises carnauba wax and the formulation comprises an aqueous carrier.

### Claim 3 (depends on 1)

The method of claim 1, wherein the detectable label is selected from the group consisting of a fluorescent label, a radioactive label, a magnetic label and a UV label.

### Claim 4 (depends on 1)

The method of claim 1, wherein the body fluid is collected prior to analyzing the respiratory fluid.

### Claim 5 (depends on 4)

The method of claim 4, wherein the collecting is carried out by a method selected from the group consisting of bronchoscopy, spontaneous sputum collection and induced sputum production.

### Claim 6 (depends on 1)

The method of claim 1, wherein the detectable label comprises a label encapsulated in a material which is not degraded in the respiratory and gastrointestinal tracts.

### Claim 7 (depends on 6)

The method of claim 6, wherein the detectable label is encapsulated in carnauba wax.

### Claim 8 (depends on 1)

The method of claim 1, wherein the detectable label is fluorescein.

### Claim 9 (depends on 1)

The method of claim 1, wherein the analyzing comprises determining a number of labels per unit volume of respiratory fluid obtained from the subject.

### Claim 10 (depends on 1)

The method of claim 1, wherein the respiratory fluid is obtained by taking a sample of fluid from the respiratory tract of the subject.

### Claim 11 (depends on 1)

The method of claim 1, further comprising:
determining the respiratory fluid contains a concentration of gastric fluid indicative of aspiration of gastrointestinal contents into the respiratory tract, and
administering to the subject a medical treatment to reduce or prevent such aspirations.

### Claim 12 (depends on 1)

The method of claim 1, further comprising
determining the bodily fluid other than respiratory fluid contains an amount of gastric fluid indicative of aspiration of gastrointestinal contents into the respiratory tract, and
providing to the subject a medical treatment to reduce or prevent such aspirations.

### Claim 13 (depends on 1)

The method of claim 1, further comprising:
administering a control formulation comprising the same particles found in the diagnostic formulation to the subject during a period of time when the subject would not be expected to aspirate the formulation from the gastrointestinal tract into the respiratory tract;
accessing respiratory fluid from the subject following the administration of the control dose;
analyzing the respiratory fluid to determine the concentration of label in the respiratory fluid; and
determining that the concentration of label following administration of the diagnostic formulation is indicative of an aspiration of gastrointestinal fluid into the respiratory tract requiring intervention by comparing it to the concentration of label following administration of the control formulation.

### Claim 14

A method of diagnosing respiratory fluid in a subject suffering from gastroesophageal reflux disease (GERD), comprising:
orally administering to a subject suspected of suffering from gastro esophageal
reflux disease (GERD) a formulation comprised of a plurality of particles comprised of fluorescein and carnauba wax;
allowing the formulation to remain in the subject over a period of time during
which the subject would be expected to aspirate the formulation from the gastrointestinal tract into the respiratory tract;
accessing respiratory fluid from the subject; and
analyzing the respiratory fluid to determine the presence of fluorescein, thereby determining if the subject aspirates gastrointestinal contents into the respiratory tract.

### Claim 15 (depends on 14)

The method of claim 14, wherein the analyzing comprises determining a number of fluorescein particles per unit volume of respiratory fluid obtained from the subject.

### Claim 16 (depends on 14)

The method of claim 14, wherein the respiratory fluid is accessed by collecting fluid from lungs of the subject.

### Claim 17 (depends on 14)

The method of claim 14, further comprising:
determining the respiratory fluid contains a concentration of gastric fluid indicative of aspiration of gastrointestinal contents into the respiratory tract, and
providing an intervention to prevent or reduce such aspirations in the subject.

### Claim 18

A diagnostic formulation for determining the presence of gastrointestinal contents in respiratory fluid, comprising:
an ingestible liquid carrier; and
a plurality of particles comprised of carnauba wax and a detectable label.

### Claim 19 (depends on 18)

The diagnostic formulation of claim 18, wherein the formulation comprises an aqueous carrier.

### Claim 20 (depends on 18)

The diagnostic formulation of claim 18, wherein the labels are selected from the group consisting of a fluorescent label, a radioactive label, a magnetic label and a UV label.

### Claim 21 (depends on 18)

The diagnostic formulation of claim 18, wherein the particles comprise fluorescein encapsulated in carnauba wax.

### Claim 22 (depends on 18)

The diagnostic formulation of claim 18, wherein the particles comprise a radioactive material encapsulated in carnauba wax.

### Claim 23

A method of treating a subject suffering from entry of gastrointestinal contents into the respiratory tract, comprising:
orally administering to a subject a formulation comprising a plurality of particles, wherein the particles comprise a biocompatible material that is not destroyed in the gastrointestinal or respiratory tracts and a detectable label;
allowing the formulation to remain in the subject over a period of time during which the subject would be expected to aspirate the formulation from the gastrointestinal tract into the respiratory tract;
accessing respiratory fluid from the subject; and
analyzing the respiratory fluid to determine the concentration of detectable label in the respiratory fluid;
determining if the concentration of detectable label in the respiratory fluid is indicative of aspiration of gastrointestinal contents into the respiratory tract requiring medical treatment, and
administering to the subject a medical treatment to reduce or prevent such aspirations.

### Claim 24 (depends on 23)

The method of claim 23, wherein the body fluid is collected prior to analyzing the respiratory fluid.

### Claim 25 (depends on 23)

The method of claim 23, wherein respiratory fluid is collected using a method selected from the group consisting of bronchoscopy, spontaneous sputum collection and induced sputum production.

### Claim 26 (depends on 23)

The method of claim 23, wherein the biocompatible material comprises carnauba wax and the formulation comprises an aqueous carrier.

### Claim 27 (depends on 23)

The method of claim 23, wherein the label comprises a label encapsulated in a material which is not degraded in the respiratory and gastrointestinal tracts.

### Claim 28 (depends on 27)

The method of claim 27, wherein the labels are selected from the group consisting of a fluorescent label, a radioactive label, a magnetic label and a UV label.

### Claim 29 (depends on 27)

The method of claim 27, wherein the label is fluorescein.

### Claim 30 (depends on 27)

The method of claim 27, wherein the label is encapsulated in carnauba wax.

### Claim 31 (depends on 23)

The method of claim 23, wherein the analyzing comprises determining a number of labels per unit volume of respiratory fluid obtained from the subject.

### Claim 32

A method of treating a subject suffering from entry of gastrointestinal fluid into the respiratory tract, comprising:
orally administering to a subject a diagnostic formulation comprising a plurality of particles, wherein the particles comprise a detectable label encapsulated in carnauba wax;
allowing the diagnostic formulation to remain in the subject over a period of time during which the subject would be expected to aspirate the formulation from the gastrointestinal tract into the respiratory tract;
accessing respiratory fluid from the subject;
analyzing the respiratory fluid to determine the concentration of label in the respiratory fluid;
identifying a concentration of label in the respiratory fluid indicative of an aspiration of gastrointestinal fluid into the respiratory tract requiring medical treatment; and
providing an intervention to prevent or reduce such aspirations in the subject.

### Claim 33 (depends on 32)

The method of claim 32, further comprising:
administering a control formulation comprising the same particles found in the diagnostic formulation to the subject during a period of time when the subject would not be expected to aspirate the formulation from the gastrointestinal tract into the respiratory tract;
accessing respiratory fluid from the subject following the administration of the control dose;
analyzing the respiratory fluid to determine the concentration of label in the respiratory fluid; and
determining that the concentration of label following administration of the diagnostic formulation is indicative of an aspiration of gastrointestinal fluid into the respiratory tract requiring medical treatment by comparison to the concentration of label following administration of the control formulation.

### Claim 34 (depends on 32)

The method of claim 32, wherein the intervention comprises administering to the subject a medical treatment to reduce or prevent such aspiration.