PYREXAR Hyperthermia (HT)systems deliver therapeutic heating via noninvasive radiofrequency (RF) energy in the 75-140 MHz range (BSD-500 delivers at a fixed 915 MHz) During PYREXAR HT treatment; the cancerous tumor is gently warmed to 40˚-45˚C (104˚-113˚F) destroying malignant cells while preserving healthy tissues. Higher temperatures selectively damage cells that are hypoxic and have a low pH, a condition of cancer cells that is not present in healthy cells.
BSD-500 Superficial/Interstitial RF Hyperthermia System
The BSD-500 Superficial is a versatile, fully self-contained treatment system in a mobile configuration for maximum treatment flexibility of superficial tumors (within 1” of the skin surface).
- Generator: 915 MHz / 0-400 Watts total power and 0-60 Watts per channel / 8 Channels (no RF shielding required).
- Wave Guides: Three (3) external waveguide applicators for direct energy application to solid surface tumors (MA-120, MA-151, MA-100), including overhead suspension adjustable arm system.
- Thermometry: Eight (8) ports for thermistor type sensors, sensor simulator, and thermal probe calibration well.
- Workstation: Integrated PC with treatment planning software and touch screen monitor
Interstitial
Interstitial hyperthermia delivers heat directly to a tumor using arrays of up to 24 independent, flexible dipole antenna wires energized with eight (8) independent power channels. The BSD-500 is the most popular PYREXAR HT system in the US, with more than 50 in clinical use.
RF Generator for BSD-500
The generator develops high-frequency electrical power output from a conventional single-phase 115/220Vac source with a multi-channel independent phase and amplitude adjustment capability. An integrated computer controls forward and reflected power, phase, and power level on each channel. Frequency 915MHz.
BSD-500 Wave Guides
Using an electrical signal from the generator, the waveguide creates and projects the RF energy beam toward the treatment area. Tissue absorption of this energy beam causes warming by tissue excitation.
BSD-500 Single Source (915 MHz):
Model | Aperture (cm) | Treatment Field (cm) | Typical Power (Watts) | Configuration |
MA-100 | 10 w x 13 l | 8 w x 10 l x 2.5 d | 100 | Side-loaded |
MA-120 | 18 w x 24 l | 12.5 w x 19.5 l x 2.5 d | 250 | Side-loaded |
MA-151 | 4 w x 5 l | 2.5 w x 2.5 l x 2.0 d | 40 | Mini-Dual Ridge |
Interstitial Coaxial Wire (915 MHz):
The MA-251 is a semi-rigid 15.5 gauge wire coaxial cable providing an ellipsoidal heating pattern approximately 4.5 cm in length along the applicator shaft with heating to the wire tip. The MA-251 fits inside 5F catheters commonly used for brachytherapy.
Treatment Control Workstation
Treatments are planned and managed at a PC based workstation. The closed-loop feedback system provides automatic monitoring and control of treatment parameters, including power output, frequency (BSD-500 is fixed at 915MHz), amplitude and phase, tissue temperatures, core temperature, and treatment time.
- User-friendly, intuitive, color graphics interface with touch screen control. (Note touch screen control is in process for BSD-2000)
- Step-by-step guide for setup and treatment procedure.
- Icon selectable adjustments of treatment parameters.
- The system automatically records, displays and prints patient treatment data.
- Numerous checks are automatically performed to ensure safety for patients and the operator.
RF Shielding
All BSD-500 components are self-contained in a portable unit on swivel-locking casters with a generator, and computer assembly securely rack mounted. The rotating thermometry interface, thermal well, and interstitial coaxial wire cable applicator interface panel are oriented for easy access. The waveguide applicator support arm is mounted on a column that provides overhead suspension for superficial treatment waveguides applicators.
- Foot Print: 60 x 60cm (24” x 24”)
- Weight:
- Power Requirement: 115-230VAC +/-10% | 50-60 Hz | Current consumption < 10 amps
BSD-2000 Deep Regional RF Hyperthermia System
The BSD-2000 series systems use an annular phased array configuration of up to 8 dipole antennas to shape and focus thermal energy on targeted treatment area deep inside the pelvis, abdomen, limbs, or chest with 2D electronic focal steering with the 4 channel RF power generator. This product is available in the US under FDA HDE for cervical cancer and for all indications in Europe and Asia.
- Generator: 75 – 140 MHz / 0–325 or 0-450 Watts per channel / 4 Channels for BSD-2008B and BSD-2000U (RF shielding required).
- Phased Array Dipole Applicators: Sigma Ellipse and Sigma 60 (standard); Sigma 30 (optional in some countries).
- Sigma Base: Comfortably positions and supports the patient on sling inside phased array aperture.
- Thermometry: Eight (8) ports for thermistor type sensors, motorized thermal mapping, sensor simulator, and thermal probe calibration bath.
- Workstation: PC with treatment planning software and touch screen monitor.
- Generator: 75 – 140 MHz / 0–150 Watts per channel / 12 Channels (RF shielding required).
- Sigma Eye Applicator with 24 dipole antenna (8 dipoles per annular ring x 3 rings) to provide 3D electronic focus steering. Options allow for use with the other phased array applicators.
- Thermometry: Eight (8) ports for thermistor type sensors, motorized thermal mapping, sensor simulator, and thermal probe calibration bath.
- Integration with 1.5 Tesla MR system
- Generator: 100 MHz / 0–150 Watts per channel / 12 Channels (RF shielding required).
- Sigma Eye/MR 12 channel applicator with 24 dipole antenna (8 dipoles per annular ring x 3 rings) to provide 3D electronic focus steering
- MR image-guided real-time non-invasive thermometry
- External Water Heating/Chilling/ Circulation System
- Thermometry: Eight (8) ports for thermistor type sensors, motorized thermal mapping, sensor simulator, and thermal probe calibration well.
Components
The generator develops high-frequency electrical power output from a conventional three-phase 415Vac source with a multi-channel independent phase and amplitude adjustment capability. An integrated computer controls forward and reflected power, phase, and power level on each channel. The frequency range of 75-140MHz.
BSD-2000 Annular Phased Array (75 – 140 MHz):
Model | Aperture(cm) | Field Depth(cm) | Rings | Channels | Sources | Configuration |
Sigma 30 |
30 | 13 | 1 | 4 | 8 | Circular / single array |
Sigma 60 | 60 | 20 | 1 | 4 | 8 | Circular / single ring array |
Sigma Ellipse | 60 | 20 | 1 | 4 | 8 | Circular / single ring array |
Sigma EYE non-US |
54"Wx37"H | 20 | 3 | 12 | 24 | Ellipsoidal/triple ring array 100MHz |
Sigma EYE/MR non-US |
54"Wx37"H | 20 | 3 | 12 | 24 | Ellipsoidal/triple ring array 100MHz |
RF Shielding
Annular Phased Array waveguides use non-ISM frequencies and require RF shielding. Single Source and Interstitial Wire waveguides use the Industrial, Scientific, and Medical (ISM) radio band (915 MHz) and do not require RF Shielding.
Water Module
Water filled bolus on waveguide surface provides dielectric load and energy-confining medium.
- Modes: Fill, Drain, Circulate, Heat, and Cooling.
- Temperature Range: 25°C to 40°C
Sigma Base (BSD-2000)
The Sigma treatment base provides comfortable patient positioning and thorax-to-toe array aperture location possibilities.
- Hydraulic patient elevation/tilt.
- Dielectric patient isolation.
- Integrated hot and cold water reservoirs with quick drain capability.
Thermometry
Tumor tissue is monitored throughout treatment with temperature probes placed in interstitial catheters and/or nearby body cavities. PYREXAR HT systems use up to eight (8) TMP110 inherently stable thermistor type sensors that are non-perturbing and electromagnetically insensitive.
- The sensor diameter is approximately 1.1mm and is located at one end of a 33 cm (13 in) lead.
- Accuracy: +/- 0.2˚C over a range of 25 to 52˚C.
- The automated positioning system with the BSD-2000 allows Thermal Mapping along catheter length to measure and monitor temperature profile throughout tumor tissue.
- An integrated probe calibration system is accurate to +/- 0.05˚C over a range of 0 to 60˚C is provided with the BSD-2000, and an integral thermal well is supplied with the BSD-500.
The BSD-2000 3D/MRI employs real-time MR image-guided non-invasive thermometry using proton resonance frequency shift measurements, accurate within +/- 0.5˚C.
Treatment Control Workstation
Treatments are planned and managed at a PC based workstation. The closed-loop feedback system provides automatic monitoring and control of treatment parameters, including power output, frequency (BSD-500 is fixed at 915MHz), amplitude and phase, tissue temperatures, core temperature, and treatment time.
- User-friendly, intuitive, color graphics interface with touch screen control. (Note touch screen control is in process for BSD-2000)
- Step-by-step guide for setup and treatment procedure.
- Icon selectable adjustments of treatment parameters.
- The system automatically records, displays, and prints patient treatment data.
- Numerous checks are automatically performed to ensure safety for patients and the operator.