ViVitro Labs Model Left Heart System Components
Heart Valve Pulse Duplicator: Features
- Dual chamber pulse duplicator
- 3 independent activation systems for optimum ventricular, atrial, and systemic circulation
- Accurate ventricle and atrium anatomical models
- Versatile configuration for valve hydrodynamic performance in left and right heart
- 2 distinct valve positions - Aortic and Mitral
- Fulfill ISO 5840 and FDA guidelines requirements
- Multiple Electromagnetic flow meter and pressure transducers positions
- Compatible with valve leaflets kinematics assessment systems: high speed video
- Compatible with flow kinematics assessment systems: Particle Image Velocimetry and Echo Doppler
Measured parameters
- Valve pressure gradient measurements
- Geometric Orifice Area (valve opened) determination
- Regurgitation Orifice Area (valve closed) assessment
- Effective Orifice Area (EOA) assessment
- Regurgitant volumes measurements
Scope
- Hydrodynamic performance of artificial heart valves prosthesis - Aortic, Mitral, Pulmonary
- Hydrodynamic performance of any valvular prosthesis
- Hydrodynamic performance of surgical, transapical, TAVI and any transcatheter valves
- Hydrodynamic performance of biological, polyester, mechanical valves
Associated heart valve performance tests
- Flow characterization studies (PIV & Echo Doppler)
- Device pre-conditioning - Simulated use on IDTE 2000
- Accelerated Stent Fatigue Testing
- Post deflection, Burst pressure, Valve migration
- Accelerated Wear and Tear
- Corrosion resistance
- Steady Flow Testing
- Leaflet kinematics
- Ring integrity, Ring push off, Ring torque
- Stent creep (polymeric stent)
- Leaflet impingement & escape force (mechanical valve)
Heart Valve Pulse Duplicator:
Dual chamber pulse duplicator for hydrodynamic performance testing of heart valves. 3 independent pump activation systems for ventricular, atrial, and systemic circulation. Anatomical ventricle and atrium models. The pressure difference and the regurgitant volume can be evaluated in-vitro under different flow conditions. Ventricular stroke volume, heart rate and diastolic and systolic aortic pressures can easily be modified to customer’s requirements. The repeatability of measurements is ensured by a servo-control, which also monitors pressure and flow waveforms.
Heart Valve Pulse Duplicator: Specifications
- Custom anatomically accurate ventricle, atrium and aortic root models
- Accurate ventricle and atrium anatomical models
- Versatile configuration for valve hydrodynamic performance in left and right heart
- Custom rigid or soft aortic or mitral fixture adaptable to all valves
- Simulation of cardiac output from 2 to 7 L/min
- Tunable systolic ejection volume (30 up to 130 ml)
- Tunable heart rate (40 up to 130 cycles/min)
- Tunable systolic duration (for example: 35+/-5% of cycle at 70+/-10 c/min)
- Tunable systemic and pulmonary compliances and resistances allowing tunable aortic and pulmonary pressures waveforms
- Variable-compliance aortic chamber for stentless valve
- Compatible with high speed video systems, PIV equipment and echo doppler equipment
- GLP Qualified test bench and software
- Provided with full IQOQPQ plan and documents
Control module specifications
- High fidelity pressure difference sensor (accuracy +/- 1 mmHg FS)
- Accurate electromagnetic flow measurement (accuracy +/- 1 mL/s FS) allowing volume measurement of +/- 2mL
- Embedded temperature sensor (accuracy +/- 1° C)
- Compatible with blood analog (4 +/- 0.2 cP at test temperature) test fluid
- High speed simultaneous data acquisition of pressure, flow and temperature levels
- External trigger for echocardiographic or PIV synchronization
- Indirect real time closed-loop PID activation control system
Software specifications
- Actual pressure, flow and temperature measured, displayed and graphed
- Raw data and test parameters recorded to a CSV file