SYnaPSe™ oct SYSteM

Transcription

SYnaPSe™ oct SYSteM

SYnaPSe oct SYSteM
™
An enhanced set of instruments and implants
for posterior stabilization of the upper spine
SurgIcal technIque
Table of Contents
Introduction
Surgical Technique
SYNAPSE™ OCT System
2
AO Principles
5
Indications and Contraindications
6
Preparation7
Surgical Technique
9
Additional Techniques
20
Implant Removal
29
Assembly Guide
33
SYNAPSE OCT System Compatibility Matrix
38
Introduction
Occipital Cervical Fusion System
39
Surgical Technique
Preparation42
Occipital Plate Technique
44
Occipital Fusion Connectors
55
Occipital Clamp Technique
59
Occipital Plate/ Rod Technique
68
Implant Removal
74
OC Fusion System Compatibility Matrix
75
Image intensiﬁer control
DePuy Synthes Companies SYNAPSE OCT System Surgical Technique
dePuY SYntheS SPIne SYnaPSe™ oct SYSteM
the DePuy Synthes Spine SYnaPSe™ occipito-cervicothoracic Fixation System is an enhanced set of instruments
and implants, including clamps, top loading variable axis
screws, hooks, transconnectors, and transverse bars and rods,
designed for posterior stabilization of the upper spine. the
implants provide the flexibility required to accommodate
variations in patient anatomy.
the DePuy Synthes Spine SYnaPSe oct System uses 3.5 mm
and 4.0 mm rods, allowing components from SYnaPSe System,
aXon™ Pedicle Screw System, and DePuy Synthes Spine
occipital cervical Fusion systems to be interchanged.
additionally, tapered rods are available to extend
DePuy Synthes Spine SYnaPSe oct System constructs to
the lower spine using the DePuy Synthes Spine eXPedIuM®
Spine System.
System features
• 3.5 mm and 4.0 mm titanium* rods
• top-loading hooks
• Multiple implant options for crossing the
cervicothoracic junction
• Fully compatible with the oc Fusion System
• Square-threaded locking screws
• robust polyaxial screws
• top-loading transconnectors
*titanium-6% aluminum-7% niobium alloy
1
DePuy Synthes Spine Synapse OCT System
Top-loading transconnectors
• Head-to-head connection for increased stability
• Adjustable connector available in four variable lengths
to accommodate different patient anatomy
• Assemble on the head of any SYNAPSE Polyaxial Screw
• Straight and angled versions offer enhanced
flexibility options
DePuy Synthes Companies SYNAPSE OCT System Surgical Technique 3
dePuy Synthes Spine SYnaPSe oct System
Robust polyaxial screws
• top loading
• 4.0 screws accommodate 3.5 mm diameter and
4.0 mm diameter rods
• one-piece body
• Self-tapping
• three diameters with cancellous profile:
– 3.5 mm diameter
– 4.0 mm diameter (rescue screw)
– 4.5 mm diameter
• 3.5 mm diameter and 4.0 mm diameter cancellous screws
offer up to 50° angulation (4.0 mm diameter screws offer
up to 40° angulation)
50°
50°
Shaft screw
• lengths from 18 mm–50 mm* with a 10 mm
unthreaded shaft (2 mm increments)
• Self-tapping
• Shaft screws with cortical profile
• offers 40° angulation in all directions
the threaded driver eliminates driver
“sticking” to the bone screw.
*Screw length is total length.
1
AO Principles
In 1958, the AO formulated four basic principles, which have
become the guidelines for internal fixation.1
They are:
•Anatomic reduction
• Stable internal fixation
• Preservation of blood supply
•Early, active mobilization
The fundamental aims of fracture treatment in the limbs and
fusion of the spine are the same. A specific goal in the spine
is returning as much function as possible to the injured
neural elements.1,2
1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal
Fixation, 3rd Edition. Berlin: Springer-Verlag; 1991.
2. Aebi M, Thalgott JS, Webb JK. AO ASIF Principles in Spine Surgery.
Berlin: Springer-Verlag; 1998.
Indications AND CONTRAINDICATIONS
Indications
The SYNAPSE OCT System is indicated as follows:
The Synapse OCT System, including Synapse, OC Fusion, and Axon, is
intended to provide immobilization and stabilization of spinal segments
as an adjunct to fusion for the following acute and chronic instabilities of
the craniocervical junction, the cervical spine (C1 to C7) and the thoracic
spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations;
instability or deformity; failed previous fusions (eg, pseudarthrosis);
tumors involving the cervical/thoracic spine; and degenerative disease,
including intractable radiculopathy and/or myelopathy, neck and/or arm
pain of discogenic origin as confirmed by radiographic studies, and
degenerative disease of the facets with intability. The Synapse OCT
System is also intended to restore the integrity of the spinal column
even in the absence of fusion for a limited time period in patients
with advanced stage tumors involving the cervical spine in whom life
expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Axon and Synapse
Systems may be connected to the Synthes Universal Spinal System using
parallel connectors and tapered rods. The Synapse OCT System can also
be linked to the titanium DePuy EXPEDIUM Spine System using the
3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.
CONTRAINDICATIONS
Contraindications for the use of the Synapse OCT System include:
•Active systemic infection or an infection localized to the site of the
proposed implantation
• Severe osteoporosis may prevent adequate fixation of the screws and
preclude the use of this or any other spinal instrumentation system
• Patients who have been shown to be safely and predictably treated
without internal fixation
•Open wounds
• Foreign body sensitivity
Mental or physical impairment, which compromises or prevents a patient’s
ability to comply with necessary limitations or precautions, may place
that patient at a particular risk during postoperative rehabilitation.
Factors such as the patient’s weight, activity level, and adherence to
weight- bearing or load-bearing instructions have an effect on the
stresses to which the implant is subjected. Additional factors which may
preclude the possibility of fusion include any underlying physiological
conditions such as kidney dialysis, cancer, osteopenia, smoking, or
diabetes.
The Synapse OCT System (hooks) are contraindicated for use in
postlaminectomy cases.
WARNINGS
This device is not intended for screw attachment or fixation to the
posterior elements (pedicles) of the thoracic (T4-T12) or lumbar spine.
CoCr rods are not intended to be used with the Synapse System.
Additionally, CoCr tapered rods are not intended to connect the
Synapse System to the DePuy EXPEDIUM Spine System.
The safety and effectiveness of pedicle screw spinal systems have
been established only for spinal conditions with significant mechanical
instability or deformity requiring fusion with instrumentation. These
conditions are significant mechanical instability or deformity of the
thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis
(grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis
with objective evidence of neurologic impairment, fracture, dislocation,
scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The safety and effectiveness of these devices for any other conditions
are unknown.
Please refer to package insert for complete labeling.
For detailed cleaning and sterilization instructions of the instruments
used with the Synapse OCT System, please refer to:
www.synthes.com/cleaning-sterilization.
6 DePuy Synthes Companies SYNAPSE OCT System Surgical Technique
Preparation
1
Preparation
Required set
01.614.001E
SYNAPSE Instrument and Titanium
Implant Set
or
01.615.006ESYNAPSE 4.0 mm Instrument and
Titanium Implant Set
Optional set
01.601.020EOccipital Cervical Fusion Instrument and
Titanium Implant Set
01.601.023E OC Fusion Enhancement Set for
3.5 mm Rod
01.614.001
4.0 mm Rod
01.614.021E SYNAPSE Enhancement Instrument Set
01.614.020E 3.5 mm Ti Curved Rod Set for
SYNAPSE System
01.615.020E 4.0 mm Ti Curved Rod Set for
SYNAPSE System
Preparation
2
Preoperative planning
All necessary imaging studies should be available to plan
implant placement and visualize individual patient anatomy.
Use of cross sectional imaging (ie, CT and/or MRI) for posterior
cervical screw placement is recommended due to the unique
risks in the cervical spine. The use of planar radiographs
alone may not provide the necessary imaging to mitigate
the risk of improper screw placement. In addition, use of
intra-operative imaging should be considered to guide
and/or verify device placement, as necessary.
3
Position patient
Patient positioning is critical for cervical posterior fusion
procedures. Place the patient on the operating table in the
prone position with the patient’s head securely immobilized.
Proper patient position should be confirmed via direct
visualization prior to draping and by radiograph.
Always use caution when positioning the patient, as
physiologic alignment may not be attainable.
4
Approach
Use the standard surgical approach to expose the spinous
processes and laminae of the vertebrae to be fused.
5
Assemble instruments
The following instruments must be assembled prior to use:
•Screwdriver
•Persuader
•Drill Guide
•Depth Gauge
Assemble instruments according to the assembly
instructions found on page 33–37, or refer to
www.synthes.com/cleaning-sterilization.
Surgical Technique
1
Start screw hole
Instrument
388.397Awl
Determine the entry point and trajectory for the screw
and use the awl to create a pilot hole. This helps to prevent
displacement of the drill bit during initial insertion.
Screw Diameter Drill Bit
Drill Guide
3.5 mm
388.394
388.393
4.0 mm
388.394
388.393
4.5 mm
03.614.010
03.614.011
2
Select screw and drill guide
Instruments
388.394
Turn-to-Lock
Drill Guide
03.615.030
03.615.030
03.615.031
2.4 mm Drill Bit with 65 mm stop,
quick coupling
388.393Drill Guide with graduation, for 2.4 mm
Drill Bit
03.614.010
3.2 mm Drill Bit with 65 mm stop,
quick coupling
03.614.011Drill Guide with graduation, for 3.2 mm
Drill Bit
Alternative instruments
03.615.030*Turn-to-Lock Drill Guide for 2.4 mm Drill Bit
Select the drill bit and drill guide that correspond to the
screw diameter to be used. The 3.5 mm and 4.0 mm screws
have the same core diameter (2.4 mm) and require the use
of the same drill bit and drill guide, identified with a yellow
band. The 4.5 mm screws have a larger core diameter
(3.2 mm) and require the use of the drill bit and drill guide
identified with a light blue color band. See table to right.
*Additionally available.
Surgical Technique
3
Set drill guide depth
Instruments
Drill Bit
or
Drill Bit
To set the drill guide to the desired depth, slide back the
latch to release the inner tube; align the distal end of the
internal drill guide tube with the appropriate depth calibration
on the window. Release the latch to lock the drill guide at
the desired depth.
Alternative instrument
389.475*Drill Guide, 14 mm, for 2.4 mm drill bit
A drill guide with a fixed depth of 14 mm is additionally
available for both 3.5 mm and 4.0 mm screws.
Slide inner tube until desired depth aligns with markings.
To lock this drill guide, pull back the latch, rotate the tube
clockwise, and release the latch.
Surgical Technique
4
Drill hole
Instruments
Drill Bit
388.3942.4 mm Drill Bit, quick coupling,
with 65 mm stop
388.549
Straight Ball Tip Probe
Drill to the desired trajectory and depth, using the 2.4 mm
drill bit and drill guide. Use the straight ball tip probe to
confirm, by palpation, accurate placement within the pedicle.
Caution: Do not touch the latch when drilling.
Touching the latch could disengage the lock resulting in
uncontrolled depth and potential harm to the patient.
03.614.0103.2 mm Drill Bit with 65 mm stop,
quick coupling
Drill Bit
Alternative technique
Instruments
03.614.012
Pedicle Probe, 2.4 mm
03.614.013Curved Pedicle Probe, 2.4 mm
Pedicle preparation may also be performed using either the
pedicle probe or curved pedicle probe.
Surgical Technique
Optional technique
Instruments
389.473
Small Pedicle Marker, beaded
389.474
Small Pedicle Marker, long beaded
The small pedicle markers may be used to radiographically
confirm position and orientation of screw sites.
5
Measure
Instrument
03.161.028Depth Gauge
Use the depth gauge to confirm hole depth and select the
corresponding screw length. The depth gauge reading and
the screw length indicate actual bone purchase. The depth
gauge must sit directly on the bone.
Surgical Technique
6
Insert screw
Instruments
03.614.017Threaded Holding Sleeve, for polyaxial screws
03.614.018Cross Pinned StarDrive™ Screwdriver
Shaft, T15, self-retaining, quick coupling
324.107Quick Coupling Handle, with swivel cap
Optional instruments
03.614.036
Slip Sleeve, for Threaded Holding Sleeve
03.614.039Cross Pinned Hexagonal Screwdriver Shaft,
quick coupling
03.614.041*Ratchet T-Handle with Quick Coupling
03.688.505*
Small Ratchet Handle with Quick Coupling
Refer to page 33–34 for screwdriver assembly and implant
attachment instructions.
Insert the selected 3.5 mm or 4.5 mm self-tapping
DePuy Synthes Spine SYNAPSE OCT System screw. A 4.0 mm
emergency screw may be used if the primary 3.5 mm screw
has less than optimal fixation.
Note: The optional slip sleeve may be used to grip the
holding sleeve during screw insertion.
Surgical Technique
Instruments
03.614.015Tap for 4.5 mm Cancellous Bone Screws,
205 mm, 50 mm calibration
03.614.016
4.5 mm/3.5 mm Tap Sleeve
311.349Tap for 3.5 mm Cancellous Bone Screws,
50 mm calibration
389.477Tap for 3.5 mm Cortex Screws,
50 mm calibration
03.614.052Undersized Tap for 3.5 mm
Cancellous Screws
03.614.053Undersized Tap for 4.5 mm
Cancellous Screws
03.614.045
Short Tap for 3.5 mm Cancellous Bone
Screws with sharp tip
03.614.046
Short Tap for 4.5 mm Cancellous Bone
Screws with sharp tip
Dense bone may be tapped using the appropriate tap,
depending on the chosen screw.
The tap sleeve may be used as a tissue protector, and to
indicate tap depth.
Tap selection guide
Undersized*
Nominal
3.5 mm Cancellous Screw
03.614.045
311.349
03.614.045
311.349
N/A
03.614.053
03.614.015
03.614.046
3.5 mm Cortex Screw
N/A
389.477
*Undersized taps are 0.5 mm smaller than nominal, eg, the Undersized tap
for 3.5 mm screws has a diameter of 3.0 mm.
Surgical Technique
7
Place additional screws
Use the same technique to insert the remaining screws.
8
Contour template
Instrument
388.868Rod Template, 240 mm (for 3.5 mm and
4.0 mm rods)
Contour the rod template to fit the anatomy.
Surgical Technique
9
Bend and cut rod
Instruments
03.614.021Rod Cutter
03.614.022Rod/Plate Bender
Use the rod/plate bender to contour the rod to match the
curve of the template. The bend line arrow indicates where
the rod will be bent.
Use the rod cutter to cut the rod to the appropriate length.
Internal ledge
Shorter rod sections may be bent by placing one end of the
rod on the internal ledge of the bending feature.
03.614.024Bending Iron, left
03.614.025Bending Iron, right
The bending irons can also be used as pipe rod benders.
Insert the rod into the rear of each bending iron and lock
in place by turning the thumbwheels clockwise. With both
ends locked inside the irons, the rod may be contoured.
Caution: Repeated bending and notching may
weaken rod.
Surgical Technique
10
Insert rod
Instrument
388.407Holding Forceps
03.614.024Bending Iron, left
03.614.025Bending Iron, right
03.614.034Alignment Tool
03.614.047*Rod Pusher/Head Turner
Insert the rod into the variable axis heads of the screws using
the holding forceps. The alignment tool may be used to help
orient the heads to the correct position. The bending irons
may be used to adjust the curve of the rod.
11
Insert locking screw
Instruments
03.614.019
StarDrive Screwdriver Shaft, T15,
self-retaining, quick coupling
03.614.0352 Nm Torque Limiting Handle, with
quick coupling
Loosely fasten the locking screws using the StarDrive
Screwdriver Shaft with the 2 Nm torque limiting handle.
When inserting the locking screws, they may be turned
one-quarter to one-half turn counterclockwise to seat the
thread before tightening.
03.614.050* Dual Sided Locking Cap Inserter
Caution: Not meant to be used for final tightening.
Surgical Technique
Instrument
03.614.027Persuader
or
03.615.009
Persuader, for 4.0 mm rods
Use the persuader to introduce the titanium rod into the
variable axis head of the screw. Place the persuader over
the rod and onto the variable axis head so the tip of the
persuader sits below the screwhead reduction feature.
Squeeze the handle to engage the persuader and introduce
the rod into the head of the screw. Loosely fasten the
locking screws using the StarDrive Screwdriver Shaft with
the 2 Nm torque limiting handle through the cannulation of
the persuader. When inserting the locking screws, they may
be turned one-quarter to one-half turn counterclockwise to
seat the thread before tightening.
Optional instrument
03.615.042*Locking Persuader Handle
If using the Locking Persuader Handle, squeeze the handle to
engage the pursuader and introduce the rod into the head
of the screw. Thread the nut down to lock reduced position.
Optional technique
Instrument
03.614.023Rod Holder
If rotation of the rod is desired, it is recommended that the
rod holder be used.
Surgical Technique
Optional technique
Instruments
03.615.016*Rocker Fork for 4.0 mm Rod
03.614.049*Rocker Fork for 3.5 mm Rod
Place the open center of the rocker fork onto the top of the
rod, with the feet below the screw side notches. Lever the
fork back until the rocker fork engages the side notches of
the screw. In a slow and controlled way, lever the fork until
the rod is seated into the polyaxial head.
12
Lock construct
Instruments
03.614.019
03.614.026Countertorque
or
03.615.010Countertorque, for 4.0 mm rods
03.614.035
2 Nm Torque Limiting Handle
After final adjustment of the construct, fully tighten all
locking screws with the screwdriver shaft and the 2 Nm
torque limiting handle. The construct is now rigidly locked.
Final tightening should be accomplished after all locking
screws have been placed, and should be aided by the
countertorque tool.
Note: The persuader may be used in place of the
countertorque tool.
Surgical Technique
13
Apply compression or distraction
Instruments
03.614.028Distraction Forceps
03.614.029Compression Forceps
Compression or distraction with variable axis heads is only
possible if the locking screws have not been tightened. Use
the compression forceps to achieve compression, or the
distraction forceps to achieve distraction, and then tighten
the setscrew as described in Step 12.
Note: All setscrews are designed to be flush or recessed
from the top of the implant when locked. To ensure
proper implant and rod (3.5 mm or 4.0 mm) configuration,
please verify the part number of the implant.
A. Place top loading hooks
Instruments
03.614.019
03.614.030
Implant Holding Forceps
03.614.050*Dual Sided Cap Inserter
03.688.505*
Position hook
Attach implant holding forceps to the appropriate hook.
Place the hook in the desired location using the StarDrive
Screwdriver as an aid.
Insert rod
Insert locking screw
Tighten the locking screw using the StarDrive Screwdriver
Shaft with quick coupling handle. Turn the screwdriver
one-quarter to one-half turn counterclockwise to seat the
thread before tightening.
B. Insert top loading transconnectors
Note: The DePuy Synthes Spine SYNAPSE OCT System
Top Loading Transconnector, compatible only with the
SYNAPSE OCT System, is placed on top of two
mono-segmental variable axis screws to cover the
exposed spinal cord following laminectomy.
1
Insert transconnector locking screw
Instruments
03.614.019
03.614.035
Loosely fasten the transconnector locking screws using
the StarDrive Screwdriver Shaft and 2 Nm torque limiting
handle. When inserting the transconnector locking screws,
they may be turned one-quarter to one-half turn
counterclockwise to seat the thread before tightening.
2
Lock construct
Instruments
03.614.019
03.614.026Countertorque
03.614.035
03.614.027Persuader
03.615.042*Locking Persuader Handle
After final adjustment of the construct, fully tighten all locking
screws using the screwdriver shaft and 2 Nm torque limiting
handle. The construct is now rigidly locked. Final tightening
should be accomplished after all locking screws have been
placed, and should be aided by the countertorque tool.
Note: The persuader may be used in place of the
countertorque.
3
Insert transconnector
Instrument
Select a straight or angled transconnector of appropriate
length. Place the transconnector on the DePuy Synthes Spine
SYNAPSE OCT System Screw construct to assess fit. Hold the
transconnector with the holding forceps. Adjust as necessary.
Both sides of the transconnector should be placed over the
locking screws before proceeding.
Note: Ensure the etched band on the transconnector
shaft is not visible when implanting.
Caution: Do not bend the transconnector.
4
Tighten locking nut
Instruments
03.614.019
03.614.035
03.614.040Transconnector Nut Driver, 7.5 mm
Select and place the locking nut onto the transconnector
locking screw using the 7.5 mm nut driver. To provide
alignment, insert the StarDrive Screwdriver Shaft and 2 Nm
torque limiting handle into the cannula of the 7.5 mm nut
driver and engage the T15 recess.
Loosely thread the locking nut onto the transconnector locking
screw using the 7.5 mm nut driver. After all locking nuts have
been placed, firmly tighten them with the 7.5 mm nut driver,
using the StarDrive Screwdriver Shaft and 2 Nm torque
limiting handle as countertorque.
Tip: Use the 7.5 mm nut driver to help seat the
transconnector onto the transconnector locking screw.
Note: When inserting the locking nuts, they may be
turned one-quarter to one-half turn counterclockwise
to seat the thread before tightening. Ensure the nuts
are fully seated.
Caution: Use only one hand to tighten. Overtightening
may make removal difficult. Do not turn the
transconnector locking screw with the T15 while
final tightening.
Optional technique
Instruments
03.614.048 T15 Shaft for Torque Limiting Nut Driver*
03.615.040 2.5 Nm Torque Limiting Nut Driver*
To provide allignment, insert the T15 shaft for torque limiting
nutdriver into the cannula of the torque limiting nut driver.
After locking nuts have been placed, firmly tighten them
until the nut driver clicks.
* Additionally available.
5
Lock connection
Unlocked
Instrument
388.038Crimper, for use with Transconnector
Locked
Secure the locking sleeve with the crimper. When locking the
connection, ensure that the gold tip of the instrument is
touching the gold portion of the transconnector shaft. The
transconnector is now rigidly locked.
Notes: If necessary, the connection can be unlocked
using the same instrument with the gold tip touching
the blue portion of the transconnector.
Locking more than once may weaken the
transconnector.
C. Adding rod-to-rod transconnectors
Instruments
03.614.019
388.038Crimper for Transconnector
Position the transconnector
Place the transconnector on the DePuy Synthes Spine
SYNAPSE OCT System rod construct. The transconnector
may be held with the holding forceps.
Tighten clamp
Tighten the setscrew of the transconnector hook on the
rod with the StarDrive Screwdriver Shaft. Slide the rod
within the hook if necessary. Hold the second hook in the
appropriate position and tighten the setscrew.
Tip: The rod may be bent to accommodate the
anatomy. Locking one end of the transconnector
with the crimper may facilitate placement.
Note: All setscrews are designed to be flush or
recessed from the top of the implant when locked.
To ensure proper implant and rod (3.5 mm or 4.0 mm)
configuration, please verify the part number of
the implant.
Lock connections
Lock both bushing connections with the crimper. Ensure that
the gold tip of the instrument is facing medially when locking
the connection. The transconnector is now rigidly locked.
Note: If necessary, the connection can be unlocked
using the same instrument with the gold tip facing
laterally. The rod may be shortened with the rod cutter.
D. Adding transverse bars
Instruments
03.614.019
Place the opening of the appropriate titanium transverse bar
over the rod. Loosely attach the transverse bar to the rod.
Introduce the transverse bar into the variable axis head of
the screw. Insert the locking screw in the variable axis head
as described in Steps 11 and 12 of the SYNAPSE OCT System
technique. Tighten the setscrew of the transverse bar using
the StarDrive Screwdriver Shaft.
the implant.
E. Parallel connectors
Open parallel connectors allow side loading of the rods.
Either side of the connector may be connected first. Tighten
the setscrew on one side, then connect the remaining rod
and tighten the setscrews.
the implant.
F. Tapered rods
Tapered rods may be used to extend a DePuy Synthes Spine
SYNAPSE OCT System construct. Connect the 3.5 mm or
4.0 mm section to the SYNAPSE OCT System polyaxial screws
as instructed in Steps 8–10 of the surgical technique. Connect the 5.0 mm/6.0 mm end of the rod to the appropriate
USS Spinal System.
The DePuy Synthes Spine SYNAPSE OCT System may be
linked to the DePuy Synthes Spine EXPEDIUM 5.5 Titanium
Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm
titanium tapered rods.
G. Occipital fusion technique
Occipital plates or occipital clamps may be attached to the
occiput as described in the Occipital Cervical Fusion System
Technique. These plates or clamps can then be connected to
the DePuy Synthes Spine SYNAPSE OCT System.
IMPLANT REMOVAL
Implant removal
Instruments
03.614.019
03.614.039Cross Pinned Hexagonal Screwdriver Shaft,
quick coupling
All DePuy Synthes Spine SYNAPSE OCT System implants can
be removed with a T15 StarDrive Screwdriver. The
transconnectors also require that the crimper be used
for removal.
Note: SYNAPSE OCT System Polyaxial Screws may
also be removed with the cross pinned hex shaft, with
quick coupling.
Removing top loading transconnectors
Instrument
03.614.040Transconnector Nut Driver, 7.5 mm
Alternative Instrument
03.615.040*2.5 Nm Torque Limiting Nut Driver
Remove nut
To remove the top loading transconnector, remove the nut
using the 7.5 mm nut driver.
Implant Removal
Option A
Remove transconnector
Instruments
03.614.019
03.614.035
Use the StarDrive Screwdriver Shaft and 2 Nm torque
limiting handle to unlock the locking screw and remove
the transconnector.
Remove transconnector locking screw
Instruments
03.614.019
03.614.035
Use the StarDrive Screwdriver Shaft and 2 Nm torque
limiting handle to remove the transconnector locking screw.
Implant Removal
Option B
Instrument
03.615.041* Top Loading Implant Remover
First, remove the nuts from the top loading implant.
Ensure the inner shaft has not been advanced too far before
placing over the screw/transconnector interface, otherwise
instrument will not engage.
Engage the distal end of the instrument to bottom of the
implant. While aligning the implant remover to the axis of the
transconnector locking screw, slowly turn the knob to thread
the handle down. Continue turning slowly until the implant
become released from the transconnector locking screw.
*Additionally available
Implant Removal
Option C
Instruments
Remove the 7.5 mm locking nuts
Grip the transconnector loop midline using the holding forceps.
Loosen the interface by rocking the transconnector loop
cranially-caudally, as needed to release. Move to the
opposite loop and repeat. Once loosened, remove the
transconnector.
Assembly Guide
Screwdriver
Instruments
03.614.017Holding Sleeve with thread
03.614.039Hexagonal Screwdriver Shaft,
cross pinned
Button
324.107Handle with Quick Coupling
Optional instrument
03.614.036Outer Sleeve for Holding Sleeve
No. 03.614.017
•Add the outer sleeve to the holding sleeve. Insert the
holding sleeve through the slotted end of the outer sleeve
past the threads of the holding sleeve. Snap the outer
sleeve over the “speed bump.” (Fig 1)
• Insert the back end of the cross pinned hexagonal
screwdriver shaft through the distal tip of the holding
sleeve (Fig 2). Press the button on the holding sleeve while
inserting the screwdriver shaft. Ensure that the holding
sleeve has bottomed out on the cross pin at the distal
end of the screwdriver shaft.
•Connect the handle with quick coupling to the hexagonal
screwdriver shaft (Fig 3).
•Reset the driver by pressing the button on the sleeve and
pulling back on the sleeve until it hits the handle (Fig 4).
The green color band on the sleeve should not be visible.
Green
color
band
“Speed
bump”
Driver is ready for use.
Outer
sleeve
Figure 1
Figure 2
Figure 3
Figure 4
assembly guide
Screwdriver
Attach screwdriver to polyaxial screw
• ensure that the driver is in the reset position. the green
color band on the holding sleeve should not be visible.
• Insert the tip of the hexagonal screwdriver shaft into the
bone screw of the polyaxial screw (Fig 5).
• Slide the sleeve until it comes in contact with the body
of the polyaxial screw (Fig 6).
• rotate the sleeve clockwise until it bottoms out on the
cross pin of the hexagonal screwdriver shaft (Fig 7). the
green color band should be visible. the polyaxial screw is
ready for bone insertion.
Remove screwdriver from the polyaxial screw
• rotate the sleeve counterclockwise. before accepting
another polyaxial screw, the driver should be reset as
shown in Figure 4. the green color band on the holding
sleeve should not be visible.
Figure 5
31
DePuy Synthes Companies
SYNAPSE OCT System Surgical Technique
Figure 6
Figure 7
assembly guide
PerSuader InStruMent (03.614.027)
1
2
2
1
3
SYNAPSE OCT System
Surgical Technique
35
Assembly Guide
Drill guideS
1
Drill Guide with Graduation for 2.4 mm Drill Bit 388.393
2
1
2
1
Turn-to-Lock Drill Guide for 2.4 mm Drill Bit 03.615.030
1
3
2
Assembly Guide
Depth Gauge (03.161.028)
1
2
3
4
SYNAPSE OCT System Compatibility Matrix
SYNAPSE 4.0 mm Rod System
SYNAPSE 3.5 mm Rod System
Features and Design
Rods
4.0 mm Titanium Tapered Rod
3.5 mm Titanium Tapered Rod
4.0 mm Titanium Straight Rod
3.5 mm Titanium Straight Rod
4.0 mm Titanium Pre-Curved Rod
3.5 mm Titanium Pre-Curved Rod
ScrewsAccommodate 4.0 mm Rods and 3.5 mm RodsAccommodate 3.5 mm Rods
Polyaxial
One piece body
Top-loading
Square thread locking screw
T15 StarDrive Recess
3.5 mm Titanium Cancellous Screws 3.5 mm Titanium Cancellous Screws
8 mm – 50 mm (2 mm increments)
50° maximum angulation
3.5 mm Titanium Cortex Shaft Screw 3.5 mm Titanium Cortex Shaft Screw
Hooks
Side-loading Lamina Hooks not offered withLamina Hooks (side-loading)
the 4.0 systemLeft and right offset
T15 StarDrive Recess
Top-Loading Lamina Hooks
Left, right, and straight offsets
Short and long versions
Transconnector
Top-Loading Transconnector 4.0 mm Rod-to-Rod Transconnector 3.5 mm Rod-to-Rod Transconnector
Transconnector Locking Screw and 7.5 mm Locking Nut
Additional components
4.0 mm Transverse Bars and Open Parallel 3.5 mm Transverse Bars and Open
Connectors
Parallel Connectors
occIPItal cerVIcal FuSIon SYSteM
Implants and instruments designed to optimize fixation to the occiput
the DePuy Synthes SYnaPSe oct System additionally contains
implants and instruments that are intended to provide
immobilization and stabilization as an adjunct to fusion of
the occipitocervical junction. the oc Fusion System includes
a complete set of implants and instruments designed to
optimize fixation to the occiput and easily connect with
DePuy Synthes Spine cervical and thoracic Systems.
Instruments
• Slender design maximizes visualization
• universal joint and flexible instruments accommodate
minimal exposures
• depth control on drills and taps adapt to varying
patient anatomy
Features
the oc Fusion System offers the surgeon several implant
options to maximize fixation to the occiput and minimize
the implant footprint. the instrumentation is designed to
accommodate minimal exposures and varying patient anatomy.
Midline plate construct
Lateral wedge plate construct
SYNAPSE OCT System
Surgical Technique
39
occipital cervical Fusion System
One-hole clamp construct
Two-hole clamp construct
Plate/rod construct
11
SYNAPSE OCT System Surgical Technique
Occipital Cervical Fusion System
OC Fusion implants for
DePuy Synthes Spine SYNAPSE
OCT System 4.0 mm Rods
(or plate/rod)
When used in conjunction with the
DePuy Synthes Spine Synapse 4.0
System, specific 4.0 mm implants
are necessary.
4.0 mm Midline Plate
4.0 mm Lateral Wedge Plate
One-hole and Two-hole clamps for 4.0 mm rods
4.0 mm Plate/ Rods
4.0 Top Loading OC Connector
4.0 mm Pre-bent rods
Preparation
1
Preparation
Required sets
01.601.020EOccipital Cervical Fusion Instrument and Titanium Implant Set
01.614.001E
Synapse Instrument and Titanium
Implant Set
or
01.615.006E
Synapse 4.0 mm Rod Instrument and Titanium Implant Set
01.601.020
Optional sets
3.5 mm Rod
4.0 mm Rod
01.614.001
Preparation
2
Preoperative planning
All necessary imaging studies should be available to plan
occipital screw placement and accommodate varying
patient anatomy.
3
Position patient
Patient positioning is critical for occipitocervical fusion
procedures. The patient should be placed on the operating
table in the prone position with the patient’s head securely
immobilized. Confirm proper patient position by direct
visualization before draping, and by radiograph. Always
use caution when positioning the patient, as physiological
alignment may not be attainable.
4
Approach
Make a standard midline incision from the external occipital
protuberance and continue caudally, to appropriately expose
the cervical/thoracic levels to be surgically treated.
1
Attach bone anchors
Attach bone anchors to the cervical and thoracic spine as
described in the DePuy Synthes Spine SYNAPSE OCT System,
and AXON Pedicle Screw System technique guides.
2
Select occipital plate
Instruments
03.161.0xxTemplate, for Occipital Plate
387.689
Plate Holder
Select a template of the plate style and size estimated to best
fit the occiput, as determined by the separation of the rods.
Contour the template to fit the anatomy.
3
Contour plate
Instrument
03.161.042
Plate Bender
Use the plate bender to contour the plate to fit the anatomy,
using the template as a guide. The plate bender can be used
across any section of the plate, including the area lateral to
the rod attachment bodies.
Note: Reverse bending of the plates should not be
attempted. Extreme bending over the rod attachment
body travel slot will limit the amount of medial/lateral
adjustment in the rod attachment body.
391.88Locking Pliers
Locking pliers can be used to create more acute bends.
Note: Reverse bending of the plates should not be
attempted. Extreme bending over the rod attachment
body travel slot will limit the amount of medial/lateral
adjustment in the rod attachment body.
4
Instrument
03.161.023Adjustable Drill Guide
Set the adjustable drill guide to the desired depth. Slide back
the latch to release the inner tube. Align the indicator of the
inner tube with the appropriate depth calibration on the
outer tube. Release the latch to lock the drill guide at the
desired depth.
5
Drill
Instruments
03.161.024
3.2 mm Drill Bit
387.689
Plate Holder
Caution: Do not touch the latch when drilling. Touching
the latch could disengage the lock, resulting in
Drill a hole to the desired trajectory and depth, using the
3.2 mm drill bit through the adjustable drill guide. Drill to
the stop. Drilling must occur through the occipital plate to
ensure proper drilling depth.
03.161.104
3.2 mm Drill Bit with Flexible Shaft
03.161.105* 3.2 mm Drill Bit with Flexible Shaft (new)
3.2 mm drill bit with flexible shaft through the adjustable
drill guide. Drill to the stop. Drilling must occur through
the occipital plate to ensure proper drilling depth.
6
Measure
Instrument
7
Tap
Instruments
03.161.026Tap for 4.5 mm Occipital Screws
324.107Quick Coupling Handle
Caution: Do not touch the latch when tapping. Touching
the latch could disengage the lock resulting in
Tap through the adjustable drill guide and occipital plate, to
ensure proper tapping depth.
Note: Tapping is required for all screws.
Instruments
03.161.027Universal Joint Tap for 4.5 mm
Occipital Screws
the latch could disengage the lock resulting in
Set the tap depth by turning the tap sleeve to the desired
depth. Lock the tap sleeve by turning down the locking nut
to contact the tap sleeve. Finger-tighten the lock nut. Use
the holding forceps to provide axial force and stability.
Tapping must occur through the occipital plate to ensure
proper tapping depth.
8
Insert screw
Instruments
388.392
StarDrive, Locking Screwdriver Shaft, T15
Optional Instruments
03.688.505* Small Ratchet Handle with Quick Coupling
Insert the selected 4.5 mm occipital screw and
provisionally tighten.
Note: A 5.0 mm emergency screw may be used if the
primary screw has less than optimal fixation.
Instruments
03.161.031Universal Joint Screwdriver, T15
Use the universal joint screwdriver to insert the selected
screw. Use the holding forceps to provide axial force
and stability.
9
Insert additional screws
Insert remaining screws, as in Steps 4–8.
10
Contour rod template
Instrument
388.868Rod Template, 240 mm (3.5 mm and
4.0 mm rods)
Contour the rod template to fit the anatomy and to seat fully
in the cervical and upper thoracic bone anchors. Create the
occipitocervical bend and ensure sufficient rod length to
connect with the occipital plate.
11
Bend rod
Instruments
Contour the 3.5 mm or 4.0 mm rod to match the template.
Caution: Repeated bending may weaken the rod.
Optional technique
Instruments:
03.614.055* Template for OC Rod Angles
Measure the OC Angle Using Template for OC Rod Angles.
Select a rod to match the angle as revealed by the template.
Note: If template reading shows it to be between 2 sizes,
choose the larger angle.
12
Attach rods
Instruments
03.161.041
or
03.615.007
Positioning Tool
Positioning Tool, for 4.0 mm Rod
388.392
Insert rods into the rod attachment body. Ensure that the
rods extend slightly past the end of the plate. Use the locking
screwdriver shaft to insert the titanium locking screw. Use
the positioning tool to facilitate rod placement and locking
screw insertion.
03.614.050*Dual Sided Locking Cap Inserter
Use the universal joint screwdriver and holding forceps to
insert the titanium locking screw.
13
Final tightening
Instruments
388.392
Use the locking screwdriver shaft for final tightening of all
occipital screws and locking screws.
03.614.041* Ratchet T-Handle with Quick Coupling
03.688.505* Small Ratchet with Quick Coupling
Use the universal joint screwdriver and the holding forceps
for final tightening of all occipital screws and locking screws.
OCCIPITAL Fusion Connectors
Optional technique
From Step 9, follow the surgical technique below if OC fusion
connectors are used.
1
Insert transconnector locking screw
Instrument
03.614.019
self retaining, quick coupling
03.614.035 2 Nm Torque Limiting Handle, with
Quick Coupling
Loosely fasten the transconnector locking screws to the
sub-occipital bone anchors using the StarDrive Screwdriver
Shaft and 2 Nm torque limiting handle. When inserting the
transconnector locking screws, they may be turned one-quarter
to one-half turn counterclockwise to seat the thread
before tightening.
2
Trial using the rod template, by seating the template into the
occipital plate saddle and creating the bend angle necessary
to reach the sub-axial bone anchor.
Contour a straight or angled OC connector to match the
trialed rod.
Instruments
388.868Rod Template
Caution: Do not bend the loop/bushing interface.
OC Fusion Connectors
3
Insert Occipital Connector
Instrument
388.407Holding Foreceps
Place the top loading connector over the transconnector
locking screw using the holding forceps and adjust
as necessary.
4
Insert locking screw into the occipital plate
Instrument
388.392
Use the positioning tool to facilitate rod placement and
locking screw insertion. Provisionally tighten locking screw
(do not final tighten).
Caution: Ensure the rod is flush with the plate and the
bend of the rod does not interface with the locking screw.
5
Insert the locking nut
Instruments
03.614.040 Transconnector Nut Driver, 7.5 mm
03.614.048T15 Shaft for Torque Limiting Nut Driver
03.615.040*
2.5 Nm Torque Limiting Nut Driver
Place the locking nut onto the transconnector locking screw
using the torque limiting nut driver. Insert the straight
STARDRIVE, T15 Shaft, into the cannula. Provisionally tighten
locking nut (do not final tighten).
6
Final tighten the OC locking screw
Instruments
324.107 Quick Coupling Handle, with swivel cap
388.392 StarDrive, Locking Screwdriver Shaft, T15
occipital screws and locking screws.
7
Final tighten the locking nut
Instruments
03.614.048T15 Shaft for Torque Limiting Nut Driver
03.615.040
2.5 Nm Torque Limiting Nut Driver
03.614.040 Transconnector Nut Driver, 7.5 mm
03.688.505*
Final tighten both locking nuts using the 2.5 Nm Torque
Limiting Nut Driver.
Note: If removal is required, please refer to page 30–37
and follow the same removal technique as the
Transconnector.
1
Attach bone anchors
2
Instrument
388.868Rod Template, 240 mm (for 3.5 mm
and 4.0 mm rod)
Contour the rod template to fit the anatomy and to seat fully
in the cervical and upper thoracic bone anchors. Create the
occipitocervical bend and ensure sufficient rod length to
connect with the occipital clamp.
3
Bend rod
Instruments
4
Place clamp on rod
Instruments
388.392
Provisionally place the occipital clamp on the titanium rod by
tightening the setscrew in the clamp to engage the rod.
5
Instrument
desired depth.
6
Drill
Instruments
03.161.024
3.2 mm Drill Bit
3.2 mm drill bit through the adjustable drill guide. Drilling
must occur through the occipital clamp to ensure proper
drilling depth.
03.161.104
3.2 mm drill bit with flexible shaft through the drill guide.
Drilling must occur through the occipital clamp to ensure
proper drilling depth.
7
Measure
Instrument
8
Tap
Instruments
03.688.505*
Tap through the adjustable drill guide and occipital clamp, to
Instruments
03.161.027Universal Joint Tap for 4.5 mm Occipital
Screws
to contact the tap sleeve. Finger-tighten the lock nut. Use
the holding forceps to provide axial force and stability.
Tapping must occur through the occipital clamp to ensure
9
Insert screw
Instruments
388.392
03.688.505*
Insert the selected 4.5 mm occipital screw.
Note: A 5.0 mm rescue screw may be used if the
4.5 mm occipital screw. Use the holding forceps to provide
axial force and stability.
10
Insert additional screws and clamps
Insert remaining screws and clamps, as in Steps 4–9.
A minimum of 2 clamps per rod is required.
11
Final tightening
Instruments
388.392
occipital screws and clamp setscrews.
031.614.041 Ratchet T-Handle with Quick Coupling*
03.688.505 Small Ratchet Handle with Quick Coupling*
Use the universal joint screwdriver and the holding forceps
for final tightening of all occipital screws and clamp setscrews.
Occipital Plate/Rod Technique
1
Attach bone anchors
2
Instrument
03.161.003Template, for Occipital Plate/Rod
Contour the template to fit the anatomy and to seat fully in
the cervical and upper thoracic bone anchors.
3
Bend rod
Instruments
4
Instrument
desired depth.
5
Drill
Instruments
03.161.024
3.2 mm Drill Bit
3.2 mm drill bit through the adjustable drill guide. Drilling
must occur through the occipital plate/rod to ensure proper
drilling depth.
03.161.104
3.2 mm drill bit with flexible shaft through the adjustable
drill guide. Drilling must occur through the occipital plate/rod
to ensure proper drilling depth.
6
Measure
Instrument
7
Tap
Instruments
Tap through the adjustable drill guide and plate, to ensure
03.161.027Universal Joint Tap for 4.5 mm
Occipital Screws
to contact the tap sleeve. Finger-tighten the lock nut.
Tapping must occur through the occipital plate/rod to
8
Insert screw
Instruments
388.392
03.688.505*
Insert the selected 4.5 mm occipital screw.
Note: A 5.0 mm emergency screw may be used if the
4.5 mm occipital screw. Use the holding forceps to provide
axial force and stability.
9
Insert additional screws
Insert remaining screws as in Steps 4–8. A minimum of three
screws per plate/rod is required.
Implant removal
All Occipital Cervical Fusion System implants can be removed
with a T15 StarDrive Screwdriver.
OC Fusion System Compatibility Matrix
OC Fusion System with 4.0 mm Rod
OC Fusion System with 3.5 mm Rod
Occipital PlatesThe Occipital Plate is available as a medial or lateral wedge, 50 mm or 60 mm wide.
The plate attaches to occiput with screws
Low-profile plate, 2 mm thick Rod attachment height, 8.5 mm
Bend grooves
Bead-blasted to minimize slippage
15° screw angulation
Rod connection points are variable to allow for rotation and lateral/medial adjustment
Titanium Occipital Plate, medial, for 4.0 mm rodsTitanium Occipital Plate, medial,
for 3.5 mm rods
Titanium Occipital Plate, lateral wedge, for Titanium Occipital Plate, lateral wedge,
4.0 mm rods
for 3.5 mm rods
Occipital Screws
4.5 mm and 5.0 mm Titanium Occipital Screws, 4 mm–18 mm long in 2 mm increments
Lengths denote screw purchase
Larger screw core provides increased strength
Screw pitch reduced to provide additional purchase and tactile feedback during insertion
ClampsTitanium Occipital Clamp, 2 holes (4.0 mm)Titanium Occipital Clamp, 2 holes
(3.5 mm)
Titanium Occipital Clamp (4.0 mm)Titanium Occipital Clamp (3.5 mm)
RodsRods attach to plate with 4.0 mm capable Rods attach to plate with 3.5 mm
locking screws
capable locking screws
Straight and Pre-bent Rod
4.0 mm Rod, 240 mm 3.5 mm Rod, 240 mm
Rods attach to cervical spine with clamps, plates, or plate/rod
Locking Screw
SYNAPSE OCT System Locking Screw AXON Locking Screw
OC Fusion Connectors 4.0 mm Top Loading OC Fusion Connectors
3.5 mm Top Loading OC Fusion
Connectors
Limited Warranty and Disclaimer: DePuy Synthes Spine products are sold with a limited warranty to the original purchaser against defects in
workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.
WARNING: In the USA, this product has labeling limitations. See package insert for complete information.
CAUTION: USA law restricts these devices to sale by or on the order of a physician.
To order in the US, call Johnson & Johnson Health Care Systems Inc. Customer Support Services at 800-255-2500.
Not all products are currently available in all markets.
This surgical technique is not intended for distribution in Canada.
Manufactured or distributed
in the United States by:
Synthes USA, LLC
1101 Synthes Avenue
Monument, CO 80132
Tel: +1 (800) 227-6633
www.depuysynthes.com
© DePuy Synthes 2015. All rights reserved.
DSUS/SPN/1114/0576(1) 3/15 DV

SYnaPSe™ oct SYSteM

Transcription

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