Heart Valve Pulse Duplicator - ViVitro Labs Model Left Heart System Components

 

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