IP Library Granted Patent US 10,827,969
Granted Patent B2
US 10,827,969 · App. 13/943,466 · Granted Nov 10, 2020

Breath test device and method

Inventors: Ilan Ben-Oren (Modiin, IL); Gil Guggenheim (Jerusalem, IL); Avraham Hershkowitz (Shimshon, IL); Yaron Ilan (Jerusalem, IL)
Assignee: EXALENZ BIOSCIENCE LTD.
A61B5/4244A61B5/0205A61B5/082A61B5/4866A61B5/7278A61K49/00A61K51/04A61K51/0402A61K51/1206G01N33/497G01N33/6848G06F19/00G16H50/20G01N2800/042G01N2800/085Y02A90/26
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Quick Facts
Patent No.
US 10,827,969
App. No.
13/943,466
Granted
Nov 10, 2020
Kind
B2
Abstract

There is provided a method of evaluating a liver condition of a subject, the method includes computing a fluctuation parameter from a liver breath test based on at least one of a percentage dose recovery (PDR) curve and a delta over baseline (DOB) curve of an isotope labeled methacetin, or a salt or a derivative thereof, and evaluating at least one liver condition of the subject, based at least on the fluctuation parameter. There is provided herein a method of evaluating a liver condition of a subject, the method includes computing a hepatic impairment score based at least on a breath test related parameter and on a demographic parameter.

Claims (22)

1. A method for non-invasively evaluating portal hypertension in a subject, comprising:

administering to a subject an isotope labeled methacetin or a salt or a derivative thereof comprising carbon-13, carbon-14, oxygen-18 or any combination thereof;

continuously collecting and analyzing, using a CO 2 sensor, changes in time of a level of a metabolic product of the labeled methacetin or the salt or the derivative thereof in multiple samples of the subject's breath;

receiving, in real-time, data indicative of magnitude of metabolization, percentage dose recovery (PDR), and cumulative PDR (CPDR);

deriving, from the data, PDR peak time, PDR height or physiological noise;

evaluating, via a processor, the portal hypertension based on an analysis of the derived PDR peak time, PDR height or physiological noise; and

outputting an indication of the evaluated portal hypertension in the subject.

2. The method of claim 1 , further comprising following-up on the portal hypertension after a predetermined period of time based on the isotope labeled methacetin breath test.

3. The method of claim 2 , wherein the predetermined period of time is between 0.5 minute and 4 hours.

4. The method of claim 1 , further comprising computing an output indication related to the evaluated portal hypertension.

5. The method of claim 1 , further comprising receiving a demographic parameter of the subject, wherein evaluating the portal hypertension is further based on the demographic parameter.

6. The method of claim 5 , wherein the demographic parameter comprises height, weight, age, gender, smoking habits, disease etiology, known information about complications, or any combination thereof.

7. A device for non-invasively evaluating portal hypertension, the device comprising:

a CO 2 sensor adapted to sense changes over time of an isotope level of a metabolic product of labeled methacetin or a salt or a derivative thereof in a breath of a subject having been administered isotope labelled methacetin or a salt or a derivative thereof comprising carbon-13, carbon-14, oxygen-18 or any combination thereof; and

a processor configured to:

receive, in real-time, data indicative of percentage dose recovery (PDR) and cumulative PDR (CPDR)

derive, from the data, PDR peak time, PDR height or physiological noise;

evaluate portal hypertension based on an analysis of a the derived PDR peak time, PDR height or physiological noise; and

output an indication of the evaluated portal hypertension in the subject.

8. The device of claim 7 , wherein the processor, after a predetermined period of time, is further adapted to receive follow-up data indicative of the isotope levels of the metabolic product of labeled methacetin and to derive from the follow-up data revised percentage dose recovery (PDR) value and to reevaluate portal hypertension based on the revised percentage dose recovery (PDR) value.

9. The device of claim 8 , wherein the predetermined period of time is between 0.5 minute and 4 hours.

10. The device of claim 7 , wherein said processor is further adapted to compute an output indication related to the portal hypertension.

Assignments (2)
CHANGE OF NAME Recorded Dec 12, 2022
From: EXALENZ BIOSCIENCE LTD.
To: MERIDIAN BIOSCIENCE ISRAEL LTD
Reel/Frame 062049/0131 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 18, 2014
From: GUGGENHEIM, GIL; HERSHKOWITZ, AVRAHAM; ILAN, YARON; BEN OREN, ILAN
To: EXALENZ BIOSCIENCE LTD.
Reel/Frame 032711/0459 →
Continuity (4)
Continuation 12219824 · Jul 29, 2008
Continuation In Part 12084629
Provisional Application 60735479 · Nov 11, 2005
Related Publication 20140024953A1 · Jan 23, 2014