Our Technology
The WaveClear
Medical Device System
The WaveClear 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.
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 40 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 demonstration displays the active portion of the waveguide affecting calcium chalk.
Longitudinal
Transverse
Treatment is effected
through the following
mechanisms
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.
Peripheral Vascular Disease
Peripheral Vascular Disease (PVD) affects more than 20% of the population over 70, approximately 10 million people annually.
Artherosclerosis:
- Plaque integrates into the vessel wall
- Often calcified (hard)
- Plaque is site specific (not mobile)
- Treatment is re-opening using compression or excision and sometimes stenting.
Thrombosis:
- Vessel blockage
- Composed of fibrin and erythrocytes
- Sites vary as thrombi may be mobile (may migrate to lungs).
- Conventional treatment with anticoagulants prevents new clots forming, but does not address existing clot burden.
- Clot removal needed to restore patency.
PVD Treatment Dilemma
When left behind by conservative or inefficient treatment modalities, residual thrombus can result in long-term complications and diminished quality of life after an acute PE or DVT event.
Although many modalities attempt to remove thrombus burden, mechanical and aspiration thrombectomy are some of the newest and most promising because they avoid the usage of thrombolytics and associated bleeding risks. Despite advantages, one issue that continues to plague these devices is blood loss. The benefits of removing thrombus are clear, but there exists a trade-off between capturing all the thrombus and aspirating too much blood. The need to minimize blood loss during mechanical thrombectomy procedures forces physicians to end cases before all thrombus has been removed.
The animation below shows the vascular application of the WaveClear device.
