The Synergo System is a computer-embedded intravesical irrigation system combined with an energy-delivering unit. The System includes an RF generator that delivers radio-frequency (heat) energy at 915 MHz, a drug circulating unit, and a microprocessor with application specific software.
The user interface consists of a computer, monitor with touch screen, keyboard, and bar-code reader. Application specific software monitors and records treatment parameters during an actual session and provides a user interface that instantly alerts the user if parameters are "out-of-range".
A sterile triple lumen, silicone, transurethral Foley catheter is used for drug intravesical instillation. It has thermocouples for bladder wall temperature monitoring, and an RF antenna that radiates the bladder walls, causing them to be heated to the desired temperature.
Hyperthermia is being used in many medical fields.
Synergo uses a unique combination of local microwave energy hyperthermia (heating) with simultaneous instillation of cooled chemotherapeutic drug. The target of hyperthermia is to reach effective temperature inside the tissue to enable higher drug penetration and accelerate drug-DNA reactions.
Tissue heating should be adjusted per patient and dynamically maintained during treatment while the tissue temperature is constantly measured and closely followed.
Conduction is governed by the Boltzmann equation: Heat conduction is proportional to a constant K which cannot be changed: (for example: Kfat=0.2, Kmuscle=0.38, Ksilver=420)
Since the bladder wall acts as a good thermal insulator, heat penetration from heated liquid is not efficient (conduction/convection heating). On the other hand, during microwave heating the energy is absorbed directly deep in the tissue to enable efficient homogenous heating, real-time measurement and follow-up on the tissue temperature and dynamic adjustment of the transmitted energy for each per patient over time (e.g. when blood flow in tissue is increased due to heating).*
Warm liquid does not allow any simple adjustments in order to tailor heating per patient over time (e.g. different patients have different blood circulation, different tissues, dynamic changes that occur over time such as vasodilation etc.)
Moving from hot liquid to microwave radiation in the Synergo systems was based on previous experience, as well as on articles already published by other researchers.
*These had been submitted to and recently approved by the FDA.
System Model: SYNERGO® SB-TS 101.1
Bio-compatible, single-use, 20F, silicone, custom-made, loaded with antenna and thermocouples
Drug Circulating Unit
Tubing Line PVC, single-use with reservoir
Heat Exchanger Temperature controlled
Pump Peristaltic (variable flow)
Frequency 915 MHz (+ 50 KHz)
Maximum Power 60 Watts
Sensors T-type thermocouples
Resolution 0.1°C (0.18°F)
Model Pentium 100 and above
Monitor 15” SVGA
Input Devices Membrane keyboard and touch-screen
Version 9.29 and above A.29 and above
Supply Voltage 115 and 230 VAC
Frequency 50 / 60 Hz
Line Regulation + 10%
Maximum Peak Current 5 Amp (230 VAC)
Fuses 6.3 AT 6.3x32 mm
Forced air cooling
Temperature Range Operation:
15 – 35°C (59 – 95°F)
Storage: 10 – 40°C (50 – 104°F)
Humidity Range 45 – 75%
Atmospheric Pressure 700 – 1060 hPa
European Medical Device Directive 93/42/EEC
European Medical Device Directive
(93/42 EEC) Class IIa
Class I – Type B and BF with defibrillation protection
Compliance with Standards General – Electrical – Mechanical
EN 60601-1:1993, EN 60601-1-4:1996
EN 60601-1-2:1993, EN 55011: class A,
IEC 1000-4-2 (at 3 and 8 kV),
IEC 1000-4-3 (level 2, 3 V/m),
IEC 1000-4-4, IEC 1000-4-5
Graphic Symbols & Alarms
IEC 878 (1998), EN 980 (1997)