Hydrodynamic Testing

Ylabs provides professional hydrodynamic testing services either for fast turnaround design iteration feedback or for full regulatory approval. Testing is conducted on all types of heart valve substitutes (aortic, mitral, pulmonary, tricuspid) in accordance with the most updated ISO 5840 standard (2021).

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Pulsatile Flow Testing

The purpose of the pulsatile flow testing is to obtain key indicators of valve performance including regurgitant fraction, effective orifice area, and numerous others. Ylabs standard test methods include testing at various beat rates, cardiac outputs, and back pressures. In addition to pass/fail information in accordance with ISO 5840, these methods can show design parameters such as closing volume, leakage volume, and forward flow pressure drop. Along with quantitative data, Ylabs can provide video and photography of a device while operating, providing key information on valve performance and leaflets motion.

Using the BDC HDT-500 Pulse Duplicator we are able to document pressure and flow performance characteristics of your device at:

• Valve diameter: up to 65 mm

• Cardiac Outputs of 1 - 10 L/min

• Beat rates of 2-240 BPM

• Driving waveform: sinusoidal, arbitrary

• Back pressures up to 350 mmHg 

Steady Back-Flow Leakage Testing

The purpose of the steady back-flow leakage testing is to provide, in tabular and graphic form, the static leakage volume flow rate of the heart valve substitute as a function of back pressure.

Ylabs steady back-flow leakage test apparatus is capable to generate constant back pressures, appropriate to the intended device application, and accurately measure the leakage flow rate at this conditions.

Steady Forward Flow Testing

The purpose of the steady forward flow testing is to evaluate the pressure difference across the heart valve substitute as a function of the steady forward flow in the range of 5 to 30 l/min, increasing in increments of 5 l/min.

Ylabs steady forward flow test apparatus is capable to generate flow rates  of up to 30 l/min and accurately measure the differential pressure across the sample been tested.

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Simulated Conduit

Pulsatile flow and steady back-flow leakage testing shall be performed while the heart valve substitute is deployed in a simulated conduit representing the intended implant site and deployed device diameters. Ylabs provides design, manufacturing and rationale for the simulated conduit required for your device testing.