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Set of 3
needles that make the Spirotome. The set is
designed to take large core (8 to 12 Gauge macro-)
biopsies from virtually every soft tissue, in
particular from the breast. The material is
non-magnetic and can be used clinically, with
ultrasound, CT and MRI. The lengths of the set can
be up to 10, 8 and 6 cm with 3 dimensions: 3
(minor), 4 (standard) and 5 (jumbo) millimetre
maximal diameter. The sets are available as
reusable and single use. The single use versions
have a valve mechanism to create reversible vacuum
in the helix during penetration, cutting and
harvesting.
The
Spirotome is manually usable. There is no shooting,
avoiding vital or impenetrable organs to be
accidentally touched as bones, longs, vascular
vessels etc. The procedure can be stopped at every
moment by unscrewing the Spirotome from the
tissues. The Spirotome can be used for every soft
tissue biopsy (breast, gland….) no matter what the
dept of the diseased area is. It can be used for
superficial tumours or deeper situated tumours,
tumours near to the thorax, to the bone etc. The
procedure can be done virtually everywhere: on a
simple operating table, bed, private praxis etc.
without or with little assistance. The biopsy takes
only 10 minutes, local anesthesia included. The
biopsy specimen is large compared to the diameter of
the needle set. 2 to 3 mm specimens are obtained
with a needle with a maximum diameter of 4 mm. The
Jumbo can produce specimen up to 4 mm diameter. The
reusable Spirotome can be sterilized up to 10
times. No accessories are needed. The tissue is
not damaged because it is protected through the
helix before, during and after cutting. The helix
has high visibility on ultrasound and other imaging
techniques. Hereby, the examiner can see under
ultrasound how and to what extent the helix
penetrates the diseased area. It brings absolute
medico-legal proof that the diseased area indeed is
harvested. Usually one insertion of the needle is
necessary for a representative biopsy so that
seeding of tumour cells can be overcome. .The skin
entering part is a trocar but the tumour entering
part is a very tiny point of the helix. This is an
advantage for example, a fibroadenoma can first be
'hooked up' before the cutting action is exerted.
The system is proofed to be ideal for stereotactic
tables and MRI imaging. For the stereotactic
tables, the Spirotome was elected as most performing
for regular use at the tables. Since the Spirotome
is the only system with no magnetic characteristics
its use in MRI imaging is obvious. The breast array
coil is adapted for the Spirotome.
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