THE TECHNOLOGY

The Technology
The Science behind RF energy
System specifications

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 homogeneous 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
 

Catheter System

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

Peltier system

Pump Peristaltic (variable flow)

RF Generator

Frequency 915 MHz (+ 50 KHz)
Maximum Power 60 Watts

 

Thermometry System

Sensors T-type thermocouples
Resolution 0.1°C  (0.18°F)

 

Personal Computer

Model Pentium 100 and above
Monitor 15” SVGA
Input Devices Membrane keyboard and touch-screen

Software

Version 9.29 and above A.29 and above
 

Power Requirements

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

 

Cooling

Forced air cooling
 

Environmental Requirements

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

 

Conformity

European Medical Device Directive 93/42/EEC
 

Classification

European Medical Device Directive

(93/42 EEC) Class IIa
IEC 601-1

Class I – Type B and BF with defibrillation protection
 

Compliance with Standards General – Electrical – Mechanical

EN 60601-1:1993, EN 60601-1-4:1996

Electromagnetic Compatibility

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)