-
· This product is followed CE and FDA standard regulations.· For
more information, contact BM Korea Customer Service at (82) 31 451
9295
BM KOREA CO., LTD.104-907, SK Ventium, 166, Gosan-ro, Gunpo-si,
Gyeonggi-do, 15850, KoreaT.+82-31-451-9294,5 F.+82-31-451-9248
www.bmkmedi.com
MIS Screw System Surgical ManualWe will always make our best
endeavor for clients and patients.
GALAXY TM
-
BM KOREA CO., LTD. GALAXY TMMIS Screw System Surgical Manual
INTRODUCTIONThe GALAXYTM MIS Screw System is developed to
facilitate the surgical correction of spinal deformities by
providing temporary internal fixation and stabilization during bone
graft healing and/or fusion mass development. The GALAXYTM MIS
Screw System consists of GALAXYTM MIS Screw (cannulated poly
screws), GALAXYTM MIS ROD(straight type rods or pre-bent type rods)
and GALAXYTM Set Screw(set screw components) that can be used
through percutaneous surgical approach. The com-ponents are
available in a variety of diameters and lengths in order to
accommodate bodily structures of patients and are fabricated from
titanium alloy (ASTM F 136). The implants are provided with
non-sterile.
DESIGN CHARICTERICS The GALAXYTM MIS Screw System consists of
cannulated poly screws, straight type rods, pre-bent type rods, and
set screw. 1) MIS Screw(cannulated Poly screw) 3) Set Screw
2) Rod
▲ Straight Type ▲ Pre-bentType
INDICATIONS FOR USEThe GALAXYTM MIS Screw System is intended to
provide immobilization and stabilization of spinal segments in
skeletally mature patients as an adjunct to fusion in the treatment
of acute and chronic instabilities or deformities of the thoracic,
lumbar and sacral spine. And the GALAXYTM MIS Screw System can be
used in an open approach and a percutaneous approach with MIS
instrumentation.
The GALAXYTM MIS Screw System is intended for posterior,
non-cervical, spinal fixation in skeletally mature patients as an
adjunct to fusion for the following indications; degenerative disc
disease(de-fined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radio-graphic
studies);spondylolisthesis; trauma(i.e., fracture of dislocation);
spinal stenosis; curvatures (i.e.,scoliosis, kyphosis and/or
lordosis); tumor; pseudarthrosis; and/or failed previous fusion in
skele-tally mature patients.
When used in a posterior percutaneous approach with MIS
instrumentation, the GALAXYTM MIS Screw System is intended for
noncervical pedicle fixation for following indications:
degenerative disc disease(defined as back pain of discogenic origin
with degeneration of the disc confirmed by stenosis; deformities;
curvatures(i.e.,scoliosis, kyphosis, and/or lordosis);tumor,
pseudoarthrosis; and failed previous fusion in skeletally mature
patients.
PRINCIPLE OF OPERATION/MECHANISMMinimally invasive spinal
surgery techniques are rapidly evolving. Traditional spinal surgery
carries a risk for injury to back muscles and is associated with
significant blood loss, ong-term hospitalization and time of
recovery. Bus The GALAXYTM MIS Screw System indicates that
minimally invasive spinal surgery reduces these drawbacks.
ADVANTAGE• Anatomical shape• Minimally invasive procedure with
simple steps • Preservation of the supraspinous ligament and bone
tissue
GUARDIAN-SGTM KYPHOPLASTY SMALLER INSTRUMENT SYSTEM
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BM KOREA CO., LTD. GALAXY TMMIS Screw System Surgical Manual
01. PREPERATIONUse A/P view and lateral fluoroscopy to identify
and target the appropriate level(s).
02. PATIENT POSITIONINGThe Patient should be positioned prone
lying face down on the operating table.
03. FLUOROSCOPIC PLANNING OF INCISION POINTSTo determine the
incision point, identify the entry point of the pedicle, which is
at the intersection of the superior facet and the transverse
process, with the fluoroscopic imaging of the C-Arm on A/P View.The
incision point should be located at 1cm lateral or more depending
on patient body to the targeted pedicle entry point. This point
enables to achieve an ideal guide path for the pedicle screw by
considering muscles and the depth from the skin to the pedicle
entry point and then mark the incision point using a skin
marker.
04. PEDICLE TARGETING & GUIDEWIRE PLACEMENTInsert the
Starting Cannula and Trocar and then, remove the Starting Trocar
form the Starting Cannula. After that, insert the Guidewire through
the Starting Cannula, as the Guide-wire advances towards the base
of the pedicle, it should be ensured proper placement.
CAUTION : When the advancing the Guidewire under fluo-roscopy,
ensure the location of the Starting Cannula. Once the Guidewire is
in place, remove the Staring Cannula and leave the guidewire in
place.
05. DILATION & TAPPINGThree Dilators are used to gently make
a path of the appropri-ate dimension. Remove the Starting Cannula
and place the first Dilator 1(small) over the Guidewire;repeat it
with each Dilator 2, 3(medium, large) until all docked on the
pedicle. Once the final dilator is placed, remove two inner
dilators.
06. PEDICLE PREPARATIONAssemble Tapper and Ratchet Handle. Pass
the cannulated Tapper over the Guidewire, further perfo-rating
cortical bone and remove the Tapper.Fluoroscopy will be monitored
any nerve root irritation during procedure.
CAUTION : Choose an appropriate size Tapper by considering the
diameter of GALAXYTM MIS SCREW which will be used later.
07. MIS SCREW INSERTIONChoose the appropriate length, diameter,
and type of MIS Screw. Guide the Dilator and Screw Driver assembly
with Guidewire, and then insert it into the pedicle. Insert the MIS
Screw to the desired depth, and ensure the exact placement with
fluoroscopy. After MIS Screw’s placement, remove the Guide wire and
the Dilator from the vertebral body, leaving MIS Screw in the
vertebral body. Do the Step 1 through 7 for the second pedicle
through newly formed path. Fluoroscop-ically confirm accurate
pedicle target and place additional screws following the same
steps.
08. ROD PLACEMENT① Use a pre-bent rod, or choose the other rod
to bend.② Assemble end of the rod into Rod Holer, and then to
tight-en the rod locking. Verify that the Rod is securely attached
to the Rod Holder.③ With a rod holder, guide a rod down though the
sleeve of MIS Screw into the screw head. Fluoroscopically ensure
the appropriate rod positon. If the rod was not advanced to the
head of the screw enough, the Set Screw can be used to tighten the
rod and the head of the screw together.④ Advance the distal end of
the Rod straight down towards the Screw until it touches the top of
the Screw Head or it is as deep as the itssue will allow. Rotate
the handle of the Rod Holder toward the cephalad direction around
45°(Depending on the curvature of the spine, the Rod Holder may
need to be rotated along an arc that parallels that curvature of
the spine.)⑤ Continue to advance the Rod subfascially into the
adjacent Extensions by moving the Rod Holder towards each
subsequent Extension in a linear made. If you are unable to rotate
the Exten-sion, the Rod has properly passed within the
Extension.
09. SET SCREW INSERTIONPlace the set screw through the sleeve to
the screw head. The Set screw is tightened with audible click
handle and set screw driver. Assemble the T-handle (12N) with the
set screw driver and guide it through the sleeve into the set
screw. Turn the T-handle clockwise. Final tightening will be
completed when the T-handle is made a sound. Remove anti-torque
driver assembly and the T-handle. If difficulty is encountered
introducing the set screw into the Screw Head, the Rod may lie
above the Screw Head. Use Fluoroscopy to verify Rod placement.
10. REMOVAL OF SLEEVECut the tap with Tap Cutter completely, and
insert the sleeve cutter into the sleeve. Break the sleeve by
pulling or pushing with sleeve Cutter and remove the cut
sleeve.
Note. REMOVAL PROCEDURESTo remove a set screw form a MIS Screw,
attach the Torque limit-ing T-Handle to a set screw driver and use
the persuader or screw anti-torque device.Turn the handle counter
clockwise to loosen, and then remove the set screws completely. The
polyaxial screw housing can be remobilized with the set screw
driver guide. To remove a polyax-ial screw, use the screw driver
with the ratchet handle.
▲ Inserting Starting Cannula & Trocar
▲ Inserting Guidewire through the Starting Cannula
▲ Placing Dilator 1 / Dilator 1, 2, and 3 are placed
▲ Ratchet Handle and Tapper are assembled & Tapper is
inserted
▲ Assembled Screw driver and MIS screw
▲ Inserted MIS screw
▲ Assembled Rod holder and Rod
▲ Inserting a Rod into the sleeve of the Screw
▲ Assembled Rod, Set Screw and MIS screw
▲ Tab cutting
▲ Long-arm cutting
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BM KOREA CO., LTD. GALAXY TMMIS Screw System Surgical Manual
11. INSTRUMENTSAssembly instruments• Tapper(GXT 45/GXT55/GXT65)
& Ratchet Handle(SSRH) or T-Handle(GXTH)• Screw Driver(GXPSD)
& Ratchet Handle(SSRH) or T-Handle(GXTH)• Set Screw
Driver(GXSD) & Torque Limiting T-Handle(SSTLTH12)
Product name Model No.
Guide Wire GXGW
Dilator 1 GXD1
Dilator 2 GXD2
Dilator 3 GXD3
Product name Model No.
Tapper(4.5) GXT45
Tapper(5.5) GXT55
Tapper(6.5) GXT65
Product name Model No.
Screw Driver GXPSD
Product name Model No.
Set Screw Driver GXPSD
Product name Model No.
Rod Holder GXRH
Rod Holder Driver GXRH
Product name Model No.
Head Driver GXHD
Set Screw GXSDGDriver Guide
Product name Model No.
Screw Anti-Torque GXATD Device
Product name Model No.
01 T-Handle GXTH
02 Ratchet SSRH Handle
03 Torque Limiting SSTLTH12 T-Handle(12N)
04 Ratchet SSRIH I-Handle
Product name Model No.
Rod Bender GXRB
Product name Model No.
Long Arm Cutter GXLAC
Product name Model No.
Tap Cutter GXTC
Product name Model No.
Compressor GXC
Product name Model No.
Starting Cannula GXSCT Trocar
Dilator
Screw Anti-Torque Device
Handle
Rod Bender
Long Arm Cutter
Tap Cutter
Compressor
Starting Cannula Trocar
Tapper
Screw Driver
Set Screw Driver
Rod Holder
Driver
76 www.bmkmedi.com
-
· This product is followed CE and FDA standard regulations.· For
more information, contact BM Korea Customer Service at (82) 31 451
9295
BM KOREA CO., LTD.104-907, SK Ventium, 166, Gosan-ro, Gunpo-si,
Gyeonggi-do, 15850, KoreaT.+82-31-451-9294,5 F.+82-31-451-9248
www.bmkmedi.com
MIS Screw System Surgical ManualWe will always make our best
endeavor for clients and patients.
GALAXY TM
