Heart Valve Pulse Duplicator System ViVitro Labs’ Pulse Duplicator System is designed to assess heart valve prosthesis performance under simulated cardiac conditions. The system simulates the function of the heart’s ventricle which generates pulsatile flow through a prosthetic heart valve in a ViVitro Labs Model Left Heart. A Pulse Duplicator simulates physiological or other complex pressure variations which (when connected to the ViViTest software via sensors) provides detailed data return on prosthetic heart valve(s) and cardiac system performance. The ViVitro Labs Pulse Duplicator System is ideal for testing a variety of prosthetic heart valves. Standard and optional hardware components facilitate the mounting of mechanical, stented and stentless bioprostheses, percutaneous devices. The system is also suitable for other related cardiovascular purposes such as measurements of root compliance (in conjunction with video recording) or average coronary flow.

Heart Valve Pulse Duplicator - Hardware Features

  • Assessment of heart valve performance and function under simulated cardiac conditions.
  • View and monitor heart valves under simulated conditions via:
    • transparent parts and view ports to observe and video record valve function and adjacent flow fields;
    • aids in flow visualization studies;
    • thin acrylic windows permit ultrasound transmission for interrogation of flow fields in aortic and mitral regions;
    • transducer sites to measure wall pressures in the atrium, ventricle, aortic outflow tract, downstream of the aortic valve and upstream of the aortic and mitral valves.
  • Control pulsatile fluid flows to simulate various cardiac flow conditions to include arrhythmia, normal, hypo and hypertensive states at various cardiac outputs and beat rates.
  • Peripheral resistance and supplementary characteristic compliances to simulate cardiovascular character and resistance.
  • Control, create, download and playback cardiac waveforms at various physiological states and lower frequencies.
  • Quality data acquisition which meets verification and testing in accordance with ISO 13485 requirements and aids in the collection of data to meet ISO 5840 to FDA requirements through the use of ViViTest software.
  • Optional components enable:
    • Testing of various cardiac valve types and cardiac structures.
    • Viscoelastic simulated behavior to produce realistic ventricle pressure waveforms.
    • Operate test fluid at 37ºC to simulate physiological conditions.

Equipment Features:

• Digital precision control of a pump-in-cylinder designed linear actuator used to generate physiological flows • Stand-alone capability with five (5) preprogrammed cardiac waveforms created by user • Range of capable rates are 4 to 200 beats per minute • Range of stroke volume 0 to 150 ml • Digital controlled and created waveforms by ViViGen or ViViTest software • Control, create, input or store cardiac waveforms at various physiological states and frequencies through ViVitro software or other std waveform generating equipment

Waveform Acquisition • Waveform Analysis • Waveform Comparison• Waveform Review. One secondary utility:•Sensor Calibration; Shipped pre-installed on a PC. Components:•Laptop or Desktop PC (with monitor, keyboard and mouse)• I/O Module• NET 3.5 framework; Minimum computer software requirements: Microsoft Windows XP Professional SP3 • Windows 7 • Windows 8 • NET 3.5 framework.

Shipped pre-installed on a PC. Components: • Laptop or Desktop PC (with monitor, keyboard and mouse) • I/O Module • .NET 3.5 framework; Minimum hardware specifications: • LCD monitor capable of 1600 x 900 resolution • High throughput video card • I/O Module • 2GB RAM • 38GB Hard drive • Pentium 4 3.6 GHz Processor (single core) or better

Viscoelastic Impedance Adapter (VIA) to produce more physiological ventricular pressures: fixed resistive element, two adjustable compliance chambers • Heat exchangerto allow heating of test fluid with minimal interference of the fluid flow: Isolated inflow and outflow metal heat conducting channel transfers heat to the solution, maintains testing solution to desired temperature ± 0.5 °C • Heat Bath Temperature Controller: heated circulating baths feature a long life, high-wattage heater, optimized for the ViVitro Pulse Duplicator, Over temperature and low reservoir level cutoffs • Aortic Conduit Mount (formerly LVOT) to mount a compliant aorta and test percutaneous valves in the ViVitro Model Left Heart System: Variety of sizes from 12 mm to 29 mm ID • Transapical and Transfemoral Access for device deployment into the Pulse Duplicator; accommodate up to 26 Fr • Pressure manometer: handheld, digital pressure for calibration of pressure transducers, Accuracy: ±0.05% FS or optional ±0.025% FS • Model Left Heart: transparent parts to visualize valve function and adjacent flow fields. Ports for transducers to measure wall pressures in the left atrium, left ventricle, aortic outflow tract and downstream of the aortic valve