Heart valve steady-state leakage test device and use method thereof

Abstract

The invention discloses a heart valve steady-state leakage test device and a use method thereof, which belongs to the technical field of medical instrument inspection and comprises a water storage barrel and a water storage barrel which are communicated through a pipeline, and a test part tool for mounting a heart valve prosthesis is arranged on the pipeline so as to enable the heart valve prosthesis to be communicated with the pipeline. A front-end pressure sensor is installed on the front side of the test part tool, a rear-end pressure sensor is installed on the rear side of the test part tool, the water storage barrel is connected with an air source, and the water storage barrel is provided with a weighing device for weighing the mass change of liquid in the water storage barrel. The working method comprises the steps of calibrating, mounting the test part and measuring the static leakage rate. The technical scheme provided by the embodiment of the invention is used for carrying outthe steady-state leakage test of the artificial heart valve, is convenient to operate, meets standard requirements, and is accurate and reliable in result.

Description

technical field [0001] The invention relates to the technical field of medical device inspection, in particular to a heart valve steady-state leakage test device and a method for using the same. Background technique [0002] An artificial heart valve is a cardiac implant interventional medical device for the treatment of heart valve diseases or defects. Once a problem occurs, it will bring great risks and hidden dangers to the life safety of users, which must be identified and controlled in the pre-market quality inspection. [0003] In the quality inspection of artificial heart valves, the steady-state leakage test is a very important test item. In the industry standard GB12279-2008 "Artificial Heart Valves for Cardiovascular Implants", the test method for the steady-state leakage test is carried out. A normative overview, but no corresponding test setup is given. [0004] At present, when performing a steady-state leakage test, the artificial heart valve is generally ins...

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Problems solved by technology

[0005] 1. The relevant sensors of the assembled equipment are inconsistent with the standard requirements, which affects the accuracy of the test results;

[0006] 2. Directly pressurized by the water pump, the stability is not good;

[0007] 3. The test data is obtained by manual weighing, and the error is large, resulting in low accuracy of the result

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