The WaveClear TM Medical Device System
The WaveClear system comprises a generator that outputs a sinusoidal electrical signal at the desired frequency and a handpiece that converts the electrical energy to mechanical energy at the same frequency. Our generator is capable of outputting signals at a wide range of frequencies and has programmable output characteristics including:
- Constant current
- Amplitude modulation
- Phase tracking
The generator also includes an integrated irrigation pump and provides the user with an intuitive interface.
Longitudinal
Transverse
The electrical signal from the generator is converted into mechanical energy via an ultrasonic piezoelectric transducer contained in the handpiece that is tuned to resonate at 40 kHz. The transducer transmits longitudinal waves at 40 kHz down a flexible waveguide connected to it. As the waves travel down the waveguide their amplitude increases due to tapers along the length of the waveguide. The longitudinal waves create compressions and rarefactions in the waveguide as shown in the figure on the left. When the stress during a compression reaches or surpasses a threshold, the waveguide can no longer support the load and it buckles.
We have designed the waveguide to include a 10 cm active zone at the distal end to convert the longitudinal ultrasonic energy into 20 kHz transverse waves that deliver the therapeutic effects. We include a rotatable catheter so that the waveguide delivers energy 360° around the treatment zone.
The following animation shows a simulation of the waveguide in the active zone, demonstrating the transition from longitudinal motion to transverse motion. The colors indicate the velocity of the waveguide with red corresponding to high values and blue corresponding to low values.
The image below shows the active section of a catheter while the waveguide is undergoing transverse motion.
Treatment is effected through the following mechanisms:
- Cavitation: Selective ablation of thrombus
- Micro-streaming: re-circulates thrombus in treatment zone, producing small particulate size; fluid motion helps infuse lytic into thrombus
- Macro-motion: Wire motion reaches entire lumen, contacting and breaking apart the thrombus; low inertia of wire prevents damage to vessel walls
Our handpiece also includes two ports, one for continuous irrigation during operation and another for introduction of surgeon specified fluids such as thrombolytics or contrast agents.
WaveClear TM medical device services were established to meet the need for treatment technologies to combat vascular disease. WaveClear services particularly specialize in medical device design, research, and development, focusing on markets for ultrasonic therapeutic devices for the treatment of occlusive vasculature.