BSD-2000/3D Hyperthermia System
The BSD-2000/3D provides targeted deep regional therapeutic hyperthermia to solid tumors by applying radiofrequency (RF) energy. The BSD-2000/3D delivers energy to a patient using a power source and an array of multiple antennae that surround the patient’s body. The twenty-four dipole antennas of the Sigma Eye maximize the 3D energy convergence at the targeted treatment location.
During a treatment, the cancerous tumor is heated to 40 and 45°C (104 -113 °F). Hyperthermia damages cells in solid tumors, without damaging normal tissues, because higher temperatures selectively damage cells that are hypoxic and have low pH, a condition of tumor cells and not a condition of normal cells. Hyperthermia has been shown to inhibit cellular repair mechanisms, induce heat-shock proteins, denature proteins, induce apoptosis, and inhibit angiogenesis.
The BSD-2000/3D was designed to provide an optimized heating zone targeted to the tumor region by utilizing the adjustment of frequency, phase, and amplitude from multiple power sources. Dynamic 3D control and steering of the heating pattern size, shape, depth and position provides optimized heating since the electromagnetic energy can be targeted specifically at the tumor region. The focus is not fixed at the center of the applicator but may be targeted at any specific area, providing the system operator with significantly more freedom in positioning the applicator's heating region. The BSD 2000/3D hyperthermia system is designed particularly for treating tumors in hard-to-reach locations.
The targeted treatment area of the patient's body is enclosed by an eye-shaped applicator. Phase and amplitude steering is utilized to create the heating focus within the applicator. The 3D technology utilizes 24 dipole antennas of the Sigma Eye driven by 12 RF power channels to optimize the targeted heating. The 24 dipoles are arranged in three rings of eight antennas each. By varying the phase and amplitude of each of the 12 input channels, the operator can enhance the heating in the tumor and reduce the heating in non-target tissues.
The BSD-2000/3D consists of four major subsystems:
- RF power delivery subsystem.
- Proprietary, thermistor-based, thermometry subsystem.
- Computerized monitoring and control subsystem.
- Applicator subsystem that includes an applicator and patient support system.
- Various accessories, including a tissue equivalent QA lamp phantom that provides verification of the energy focus, pattern steering, and system operations.
- Solid-state amplifier with 12-channel independent phase and amplitude adjustment capability.
- Maximum power output of 0 to 500 watts per channel.
- Phase accuracy within a 10 degree tolerance.
- Computer automatically monitors and controls forward and reflected power, phase, and power on each channel.
- Optimized treatment settings are calculated through the use of treatment planning software tools provided with the system.
- Non-perturbing, electromagnetically insensitive, temperature sensors with an accuracy of +0.2°C over a range of 25 to 52°C.
- Automated positioning system allows the operator to map the sensor along the length of the catheter in order to determine the temperature profile.
- Precise calibration capabilities - accurate to 0.05°C over a range of 0°C to 60°C.
- Optimized power coupling.
- Optimized patient comfort.
- Water system automatically fills the bolus and controls the bolus water temperature.
- Fabric sling comfortably supports patient inside the applicator.
- Easy patient access and handling.
- Quick drain capability allows fast access to the patient – 15 seconds for patient access and 30 seconds for a complete drain.
The entire BSD 2000/3D hyperthermia system is controlled by a PC that is interfaced to all system modules. A large, user-friendly LCD color monitor, keyboard and mouse create an ergonomic operating environment. The system includes a high-resolution color inkjet printer for instant hardcopy treatment reports. The system software incorporates a color Graphic User Interface, automatically guiding the operator through the set-up and treatment procedures and featuring menu-driven selection of treatment parameters.
- User friendly, intuitive, color graphics interface.
- Step-by-step guide for setup and treatment procedure.
- Icon selectable adjustments of the treatment parameters.
- Tabs allow operator to easily switch between screen displays.
- Closed -loop feedback system provides automatic monitoring and control of treatment parameters, including power output, frequency, amplitude and phase, tissue temperatures, core temperature, and treatment time.
- System automatically records, displays, and prints patient treatment data.
- Control of power and tissue temperature to within ±0.1°C.
- Data regarding temperatures, RF power level, and RF power control updated every 2 seconds.
- Control algorithms smoothly adjust heating and cooling rates.
- The system controls the applied power level in accordance with operator inputs and automatically adjusts the level of power to maintain the operator selected temperatures throughout the treatment.
- The computer automatically performs numerous safety checks to ensure proper operation of the system and ensure safety for the patient and the operator.
The Sigma Eye is an elliptically shaped annular phased array applicator that is comprised of a clear plastic shell, 24 radiating dipoles, and a bolus membrane. The Sigma Eye provides improved comfort for patients. The twenty-four dipole antennas of the Sigma Eye maximize the 3D energy convergence at the targeted treatment location.
- Advanced annular phased array principles create a central focusing of energy, which significantly overcomes the penetration losses of the energy radiated into the body.
- Phased array applicators allow the operator to shape the heating pattern to the targeted treatment area and achieve selective power targeting at depth for treatment of deep tumors.
- Dipoles are covered by a thin dielectric layer to prevent contact with the bolus water.
- Water filled bolus dielectrically loads the individual antennas and provides an energy-confining medium that directs the RF energy into the body.
- Quick and easy patient setup.
- Plastic shell provides a clear view of the patient’s surface to allow visual verification of the applicator positioning and to facilitate monitoring of any skin color changes, which would be indicative of surface hot spots.
The BSD 2000/3D and the BSD 2000/3D/MR are not approved by the FDA for use within the United States.