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Fragmentation, emulsification and aspiration of soft tissue in the neurosurgery field.

The DISSECTRON is an ultrasonically vibrating hand-held surgical aspirator designed to precisely fragment and emulsify unwanted neurosurgical tissue, layer by layer, with preservation of major blood vessels, nerves, and elastic fibers. The DISSECTRON's selective effect on tissue is the result of three combined factors: Ultrasonic fragmentation, Irrigation, and, Suction. The DISSECTRON's principle of operation is tissular fragmentation which is achieved through uitrasonic longitudinal vibrations at an oscillation amplitude varying from 120 to 300um, at an operating frequency comprised between 23 and 35 kHz at the tip of the handpiece. The ultrasonic power is transmitted via a piezoelectric transducer, housed in the handpiece, which extends into a titanium sonotrode which is in direct contact with the tissue. It is possible to precisely dissect tissue with less surrounding tissue invasion and blood loss with DISSECTRON. Simultaneous irrigation is provided to the distal end of the tip. Sterile saline is routed from the drip holder to the control unit to the tip of the electrostrictive handpiece. A vacuum pump aspirates emulsified tissue in the pressure range of 650 hPa. Irrigating fluid and fragmented tissue particles are continuously aspirated through the distal end of the hollow titanium sonotrode (tip) and transported, via disposable tubing, to a collection bottle ("receptacle"). The DISSECTRON, a compact, portable, tabletop ultrasonic surgical aspirator installed in the surgical suite within the user's reach, consists of three primary components: the base console, the hand-piece unit, (with 2 sonotrode dedicated extensions, and, the control pedal (footswitch). The base console is controlled by a microprocessor and provides various indicators and controls designed to lead the operator through the sequential procedures needed for safe operation. Touch screen controls and displays provide the surgeon with a user friendly device. The lightweight electrostrictive handpiece is equipped with a titanium sonotrode, which acts as an ultrasonic transmitter, and is fitted with central suction and concentric irrigation. The foot pedal has two footswitches, a right switch, and a left switch, respectively, to control the Suction, Irrigation, and Ultrasound power.

The intended use of the Olympus USU is identical to the currently marketed CUSA® system 200 which was cleared for marketing in 510(k)#s K#910696 and K#921251. Both systems are used for smashing and aspirating disease tissues in the Neuro surgery field. The Olympus Ultrasonic System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field.

The Olympus USU is specially designed for open procedure in the Neurosurgery field, in order to smash and aspirate disease tissue such as cerebral tumor, cerebral hematoma, cerebral aneurysm/varicosity. Actuation mechanisms of the above systems is the same as the USU based as the following: The small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe which is mounted on the edge of hand piece. The tissue is smashed by the shock force exchanged from the vibration on the probe with pushing to the tissue. The smashed tissue is taken out by the suction space between the probe and sheath of hand piece. The Olympus USU mainly is used in microscopic surgery.