BTG Visual-ICE, Руководство пользователя

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Visual-ICE™ Cryoablation System
1-1
1 SYSTEM OVERVIEW
WARNING. A thorough understanding of the technical principles, clinical applications,
and risk associated with cryoablation procedures is necessary before using this product.
Use of this device is restricted to use by or under the supervision of physicians trained in
cryoablation procedures with a Galil Medical Cryoablation System.
CAUTION.
All new users must be trained on the use of the Visual-ICE™ Cryoablation System
and cryoablation procedures prior to operating the system. Contact your local Galil Medical
representative to schedule training.
CAUTION. Carefully read all instructions prior to use. Failure to observe all warnings and
precautions may result in complications.
1.1 Brief Description
The Visual-ICE Cryoablation System is a mobile system intended for cryoablative tissue destruction
using a minimally invasive procedure. The system is computer-controlled with a touch screen
user interface that allows the user to control and monitor the procedure. The proprietary i-Flow™
Technology controls the system’s gas flow to maintain consistent gas flow rates for the strongest
possible ice, and to optimize performance for simultaneous activation of multiple needles. Innovative
gas dryers produce consistent iceballs and boost freezing performance for all needles.
The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed
gases. The Joule-Thomson effect is a change in the temperature of a compressed gas as it flows
through a narrow orifice and expands to a lower pressure. Certain gases, such as argon, decrease
in temperature due to the Joule-Thomson effect, while other gases, such as helium, increase in
temperature.
The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation
needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through
the needles or, alternatively, by the use of a heating element inside the cryoablation needle which
can be energized to cause thawing (i-Thaw™ Technology). The Visual-ICE System also controls the
heating element inside CX-type needles to provide active helium-free thawing (i-Thaw or FastThaw™)
and track ablation (Cautery).
When multiple cryoablation needles are placed into or near the target tissue and freezing is initiated,
an iceball grows around the distal end of the needle shafts. In time, the iceballs coalesce and
completely engulf the target tissue. An important benefit of cryoablation is that imaging procedures,
such as ultrasound and CT, are able to display the location and size of the iceball. This benefit of
cryoablation is used for proper control of the therapy. During use, the procedure must be monitored
via image guidance to ensure adequate tissue coverage and to avoid damage to adjacent structures.
In addition to image guidance, Galil Medical provides temperature sensors to aid in monitoring tissue
temperature near the target site and adjacent critical structures. These temperature sensors can
provide quantitative data to supplement the qualitative information provided by the imaging modality.
Needle tip temperature display for CX-type needles provides a visual means to monitor needle
performance.
Tissue ablation is achieved by repeated freeze and thaw cycles with both freezing and thawing
contributing to cell death. Generally, multiple freeze-thaw cycles are used to achieve complete
destruction of the target tissue.