Analysis Method for Determining a Functional Parameter of an Organ Using Preferably an Aqueous 13c Methacetin Solution

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This patent describes a diagnostic method for determining organ function, particularly liver function, by administering a 13C-labeled methacetin solution—preferably intravenously—to a human or animal, and then measuring the 13CO2 content in the exhaled breath. A specially formulated aqueous solution of methacetin is used, and the change in 13CO2 is analyzed using zero-order enzyme kinetics to provide a highly quantitative assessment of liver functional capacity. The method includes a novel face mask that ensures reliable separation and collection of inhaled and exhaled air for precise measurement.

Use CasesContent extracted from patent full text and abstract with AI.

• Assessment of liver function before liver surgery (e.g., hepatectomy) to evaluate patient risk and plan procedures.
• Monitoring liver regeneration and function post-surgery or transplantation.
• Diagnosing and staging chronic liver diseases, such as cirrhosis or hepatitis, for individualized patient management.
• Evaluation of liver function in critically ill patients or in intensive care settings.
• Pharmacokinetic studies regarding liver enzyme activity and drug metabolism.
• Veterinary diagnostics for organ function in animals.

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• Provides truly quantitative, individualized results of liver functional capacity, unlike prior art methods.
• Enables rapid, non-invasive, and reliable assessment of liver function with high accuracy.
• Reduces uncertainty caused by patient-specific factors (like variable drug resorption or body weight) through intravenous administration and normalization processes.
• Facilitates early detection of subtle changes in liver function, supporting timely and more precise medical decision-making.
• Improves patient safety by identifying those at high risk for liver surgery or transplantation complications.
• Special face mask design ensures accurate sampling without contamination, making the diagnostic results more robust.

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Patent Abstract

The invention relates to an analysis method for determining a functional parameter of an organ of a human or animal individual by measuring the 13CO2 content in the air exhaled by the individual to which a substrate has been administered the reaction of which in the body of the individual enriches the air exhaled by the individual with 13CO2. The method is characterized by using a measuring device, the maximum reaction rate of the substrate in the body of the individual being determined via a change of the measured 13CO2 content in the air exhaled by the individual using zero-order enzyme kinetics. The invention also relates to an aqueous methacetin solution for use in said analysis method, the pH of the solution being greater 7.0. The invention also relates to a face mask (1) for use in the inventive method for separating the exhaled air from the air inhaled by an individual. Said face mask comprises a face mask body (2) and an air cushion (3) encircling the face mask body. Said air cushion is filled with a gas and establishes a substantially gas-tight contact between the face of the individual and the face mask (1) placed on the face of the individual so that the air required by the individual for breathing and the air exhaled by the individual has to flow essentially completely through the face mask (1). At least one exhalation valve (5) and at least one inhalation valve (4) are integrated into the face mask and allow a flow of inhaled and exhaled air through the face mask. The invention finally relates to a diagnostic method for determining the functional parameters of an organ of a human or animal individual.