monarch st 2.2synthes.vo.llnwd.net/o16/llnwmb8/int mobile/synthes international... · introduction...
TRANSCRIPT
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Deformity - Degenerative
Interbody Fusion
Tumour - Trauma
Cervical
Emerging Technology
Surgical Technique
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Introduction & Philosophy 2
Surgical Technique
Monarch™ Bolts with Spine Plates 3
Pedicle Bolt Insertion 3
Washer Rules 4
Polyaxial Washer Insertion - ‘Dome Down’ 5
Polyaxial/Spacer Washer Application 6
Polyaxial Washer Insertion - ‘Dome Up’ 7
Domed Nut Application 9
Reduction - Spine Plates 10
Reduction Technique 11
Domed Nut Final Tightening 12
Monarch™ Bolts with Slotted Connectors 13
Polyaxial Washer Insertion - ‘Dome Down’ 13
VHG – Groove 14
Polyaxial Washer Insertion - ‘Dome Up’ 14
Slotted Connector Final Tightening - Step 1 15
Slotted Connector Final Tightening - Step 2 16
Slotted Connector Final Set Screw Tightening 17
Monarch™ Bolts with Polyaxial Band Clamps 18
Polyaxial Band Clamp 18
Polyaxial Screw Insertion 20
Monarch™ Polyaxial Screws 21
Polyaxial Screw Driver Application 21
Rod Insertion 23
Typhoon Cap Appplication 24
Rod Reduction - Typhoon Approximator 25
Rod Reduction - Rocker/Camlok 28
Typhoon Cap - Compression/Distraction 30
Typhoon Cap Final Set Screw Tightening 31
Typhoon Cap Final Set Screw Loosening 32
Monarch™ Hooks 34
Pedicle Hooks 34
Transverse Process Hooks 36
Laminar Hooks 37
Offset Hook Holder 38
Cephalad/Caudal Hook Holder (5.50 mm only) 39
MONARCH™ SPINE SYSTEM
Contents
1
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Building upon decades of cumulative
design history, clinical experience and
biomechanical performance of the
VSP™, Isola® and MOSS® Miami
systems, the Monarch™ Spine System
represents the combination of existing
design principles with revolutionary
new technology.
Monarch’s technique simplifying
designs, including a state of the art
internal closure mechanism and a
unique set of fixed or polyaxial implant
options, maximise performance to
meet the challenge of even the most
difficult pathologies.
Developed for comprehensive,
multi-pathology application, Monarch™
seamlessly integrates an unprecedented
breadth of versatile and complementary
components in a single implant system.
The Monarch™ Spine System offers
fine-tuned solutions derived from the
ultimate union of simplicity and
sophistication.
Primary Indications Include:
Use of pedicle screws, hooks, plates
and rods in situations of deformity
or spinal instability such as:
• Degenerative disc disease
(discogenic back pain with
degeneration of the disc)
• Idiopathic scoliosis
• Neuromuscular scoliosis/
kyphoscoliosis
• Scoliosis with deficient posterior
elements such as that resulting from
laminectomy or myelomeningocele
• Spondylolisthesis
• Instability following a previously
failed fusion
• Spinal fractures (acute reduction
or late deformity)
• Neoplastic disease
Contraindications Include:
• History of infection
• Bony abnormalities preventing safe
screw fixation (dysplastic pedicles)
• Patients who can be safely and
predictably managed without
internal fixation
• Morbid obesity
• Severe osteopenia
• Open wounds
INTRODUCTION & PHILOSOPHY
2
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Note: All bolts are self-tapping.
Taps are provided for
surgeon preference.
Note: See Pedicle Bolt Driver
Assembly on Page 4.
Bolts are inserted into the pedicle
using the Pedicle Bolt Driver.
Monarch™ Bolts with Spine Plates
Pedicle Bolt Insertion
3
Pedicle preparation is performed using
a selection of awls, pedicle probes,
ball tip feelers and bone taps.
Probes and bone taps are marked
to help bolt selection.
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Pedicle Bolt Driver Assembly:
The Pedicle Bolt Driver is placed over
the threaded post until seated firmly
into the integral nut drive feature.
Polyaxial ‘Dome Down’
Polyaxial ‘Dome Down’ is used
beneath either a Spine Plate or Slotted
Connector. A single Polyaxial Washer
must be placed ‘dome down’ into the
integral nut of a Pedicle or Reduction
Bolt, or the receiving portion of
a Spacer Washer.
Polyaxial ‘Dome Up’
Polyaxial ‘Dome Up’ issued where a
Polyaxial Washer has been placed
beneath a Spine Plate or Slotted
Connector. One must be placed above
in the opposite orientation, i.e. ‘dome
up’ to mate with the bottom of the
Domed Nut.
Spacer
Spacer Washers may only be placed
beneath a Spine Plate or Slotted
Connector, directly into the integral
nut of a Pedicle or Reduction Bolt.
Spacer Washers must not be placed
on top of Polyaxial Washers.
Note: A total of two washers
(two Spacer, or one Spacer
and one Polyaxial) is permitted
below a Spine Plate or Slotted
Connector on a Pedicle Bolt. If
additional Washers are required,
a Reduction Bolt must be used.
Washer Rules
4
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5
Appropriate selection and insertion of
Pedicle & Reduction Bolts is completed.
Where necessary, Polyaxial and/or
Spacer Washers are applied to Bolts.
Polyaxial Washers must be placed
‘dome down’ under the Spine Plate.
Polyaxial Washer Insertion - ‘Dome Down’
Note: See Polyaxial/Spacer
Washer Application on Page 6.
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Instrument Selection
Select the appropriate
Washer Inserter instrument.
Washer Loading
Rotate handle anti-clockwise until the
counter shows the number of washers
you want to apply to the bolts.
Select Washers ‘dome down’ or ‘dome
up’ from appropriate columns of the
caddy. Press tip of Washer Inserter into
each Washer until the selected number
of Washers have been retained.
Polyaxial/Spacer Washer Application
Spacer Washer Inserter Polyaxial Washer Inserter
Down Up
Note: ‘Dome Down’ shown.
6
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Washer Unloading
Washers are released onto Bolts with a
single clockwise rotation of the handle.
Note: ‘Dome Down’ shown.
Polyaxial Washer Insertion – ‘Dome Up’
7
Select appropriate Spine Plates to
place over selected Bolts and Washers.
Contour Spine Plates if necessary and
place over machine thread of Bolts.
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Where Polyaxial Washers were placed
on Bolts below the Spine Plate, a
second Washer must be placed ‘dome
up’ on each Bolt on top of the Spine
Plate. Spacer Washers must not be
placed above Spine Plates.
Domed Nut Loading
Domed nuts are easily removed from
the Washer/Nut Caddy using either
the Domed Nut Torque Shaft or the
Domed Nut Driver.
Note: See Polyaxial/Spacer
Washer Application on pages 6-7.
8
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Apply Domed Nuts using a Domed Nut
Driver or Domed Nut Torque Shaft.
Where reduction is necessary, first
apply the Domed Nuts to the
Stabilising Bolts (i.e. L4 and S1 Pedicle
Bolts as shown above). Then apply the
nuts to the Bolts that will perform the
reduction (i.e. the Reduction Bolts in
the L5 pedicle as shown above).
Provisionally tighten the Stabilising
Bolts prior to reduction.
Domed Nut Application
9
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Prior to tightening the Domed Nut
to reduce the vertebral body, the
Hexlobe Driver must be placed into the
hexlobe feature on the top of the
Reduction Bolt to prevent the Bolt
from advancing into the pedicle.
The reduction manoeuvre is
performed accordingly.
Reduction – Spine Plates
Note: See Reduction Technique
on Page 11.
10
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Bolt Compression/Distraction Option:
Compression or Distraction with Bolts
may be accomplished using the Bolt
Style Compressors or Distractors with
associated instruments in the set.
Reduction Technique
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Nut Torque Shaft inserted into the
T-Handle Torque Wrench, which is set
to 100 in-lb (11.3Nm).
The Hexlobe Driver is placed through
the cannula of the T-Handle Torque
Domed Nut Final Tightening
The T-Handle Torque Wrench is
always set to 100 in-lb (11.3Nm)
for Domed Nut tightening.
Domed Nut Final Tightening
Note: See Domed Nut Final
Tightening (below).
Wrench to prevent the Bolt advancing
into the pedicle. The T-Handle is then
rotated clock-wise until it clicks and
resistance is no longer evident.
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Pedicles are prepared as shown
previously for Spine Plates.
Appropriate selection and insertion
of Pedicle and Reduction Bolts
is completed.
Where necessary, Polyaxial and/or
Spacer Washers are applied to Bolts.
Polyaxial Washers must be
placed ‘dome down’ under
the Slotted Connectors.
Note: See Polyaxial/Spacer
Washer Application shown
previously for Spine Plates
(see Page 6-7).
Monarch™ Bolts with Slotted Connectors
Polyaxial Washer Insertion - ‘Dome Down’
13
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Note: See Polyaxial/Spacer
Washer Application
shown previously for Spine
Plates (page 6).
14
Where Polyaxial Washers were
placed on Bolts below the Slotted
Connectors, a second Washer must be
placed ‘dome up’ on each Bolt
on top of the Slotted Connector.
Spacer Washers must not be placed
above Slotted Connectors.
Appropriate style Slotted Connectors
are chosen for optimal connection
to each Bolt.
The Slotted Connectors are loosely
loaded onto the selected length
rod and placed over the threaded
posts of the Bolts.
Polyaxial Washer Insertion – ‘Dome Up’
VHG – Groove
VHG stands for V-Groove Hollow
Ground. The V-Groove is formed by
two distinct radiuses producing an
uneven oval. The rod is forced into a
smaller groove for superior fixation.
In addition, there are two raised shelves
that produce a Hollow Ground area
in the center that allows for multiple
fixation points with a curved rod.
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Note: See Domed Nut
Application shown previously
for Spine Plates (see Page 9).
Slotted Connector Final Tightening – Step 1
Final tightening is first performed on
the body of the Slotted Connector to
ensure proper seating of the rod into
the VHG groove.
The X25 Torque Shaft is inserted into
the T-Handle Torque Wrench, which is
set to 80 in-lb (9Nm).
15
The shaft is inserted through the
Closed Connection Stabiliser and
then into the Set Screw of the
Slotted Connector body.
Appropriate style Slotted Connectors
are chosen. Apply Domed Nuts and
gently tighten using a self-retaining
Domed Nut Driver or Domed Nut
Torque Shaft.
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The Stabiliser is passed down over the
body of the Slotted Connector and
onto the rod.
The T-Handle is then rotated clockwise
until it clicks and resistance is no
longer evident.
Note: See Domed Nut Final
Tightening shown previously
for Spine Plates (page 12).
Final tightening is then performed on
the Domed Nuts.
Slotted Connector Final Tightening – Step 2
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The T-Handle Torque Wrench is always
set to 80 in-lb (9Nm) for Set Screw
tightening (Figure 2).
Figure 1
Figure 2
Slotted Connector Final Set Screw Tightening
The Closed Connection Stabiliser is
used to prevent torsion of the construct
during final tightening (Figure 1).
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The Band Clamp’s integrated polyaxial
washers eliminate assembly.
The Band Clamps are easily
pre-loaded onto the spinal rod.
Pedicles are prepared as shown
previously for Spine Plates. Appropriate
selection and insertion of Pedicle and
Reduction bolts are completed.
Monarch™ Bolts with Polyaxial Band Clamps
Polyaxial Band Clamp
Bolts with Band Clamps
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Final tightening is then performed
on the Domed Nuts.
19
Utilising a Rod Holder, position
the Band Clamps and rod over the
Pedicle Bolts.
Final tightening is then performed on
the Domed Nuts.
Note: See Domed Nut Final
Tightening shown previously
for Spine Plates (page 12).
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Probes and Bone Taps are marked to
indicate appropriate length Polyaxial
Screw selection.
Polyaxial Screws are inserted utilising
the Polyaxial Screw Driver.
Polyaxial Screw heads are remobilised
with the Polyaxial Head Positioner
if necessary.
20
Polyaxial Screw Insertion
Note: See Polyaxial Screw
Driver Application (page 21).
Pedicle preparation is performed
utilising a selection of Awls, Pedicle
Probes, Ball Tip Feelers and Bone Taps.
All Screws are self-tapping. Taps are
provided for surgeon preference.
Monoaxial Screws
Monoaxial Screws may be used
according to surgeon preference.
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Step 3 – “Alignment Guide Loading”
Insert the screw (on the driver) into
the appropriate diameter hole in the
Alignment Guide. Push the screw
down until it is seated.
21
Monarch™ Polyaxial Screws
Polyaxial Screw Driver Application
Step 1
Step 2
Step 3
Note: Use of Alignment Guide
is not needed with
Monoaxial Screws.
Step 1 – “Off”
Assembly mechanism must be in the
“Off” position. Place onto head of
screw as shown with Tightener tip
withdrawn from shoulder of head.
Step 2 – “On”
Hold screw onto shaft while holding
shaft steady. Twist knurled knob from
“Off” indicator until etch line on knob
reaches “on.”
Polyaxial Screw Driver Loading/ Unloading
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Step 4 – “Screw Shank Locking”
Hold shaft and rotate driver handle
clockwise until tight.
The Loading Block will ensure that the
screw shank is straight (in line with
head). Remove the Screwdriver and
screw from the Loading Block.
Step 5 – “Removal”
Hold shaft and rotate driver handle
anti-clockwise (one turn). Continue to
hold shaft and rotate knurled knob to
“off” position to release.
Step 4
Step 5
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Choose the appropriate length rod
with desired lordosis. Place the rod
into implant heads.
Capture rod into implant by inserting
the Typhoon Cap.
23
Rod Insertion
Note: See Typhoon Cap Pick
and Insertion (page 24).
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Guide RemoveAlign
Typhoon Cap Application
Option 1
1 Insert
2 Twist
3 Retract
Option 2
1 Align 2 Insert
3 Twist
Typhoon Cap Insertion
Select the appropriate length Cap
Guide and hold firmly over the Polyaxial
Screw head and rod as shown. Select
the matching length Cap Inserter.
If resistance is felt when twisting the
Inserter, do not continue. The rod may
not be seated adequately and rod
reduction must be performed.
2. Align vertical etched line on
Inserter with line on Guide Block
and push into caddy until the
horizontal etched line mates
with top of Guide Block.
3. Remove Typhoon Cap.
Ensure Set Screw does not
protrude below bottom of
Typhoon Cap prior to insertion.
1. Place Guide Block over
Typhoon Caps.
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1. Hold Inserter in Guide in “Retract”
position. Place assembly over
Polyaxial Screw head so that the
Guide contacts the rod.
1 Retract
2 Insert
3 Twist
4 Remove
2. While holding Guide firmly onto rod,
press Inserter straight down to
bottom of J-slot.
3. Twist the Inserter anti-clockwise.
4. Remove Inserter and Guide.
Rod Reduction – Typhoon Approximator
Prep
T-Handle pin should be located at its
lowest point in the slot.
Outer sleeve should be in the retracted
(up) position.
With thumb over the T-Handle as
shown, the Typhoon Cap is picked
from the caddy and retracted into
the Approximator.
Typhoon Cap Removal
Ensure Typhoon Cap set screw is loosened.
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Connect
With the Barrel and T-Handle at their
highest positions, and the sleeve
retracted, the springs are connected to
the open implant head holding features.
The sleeve is then slid down over
the springs to lock the instrument
to the implant.
Reduce
The rod is reduced by turning the outer
barrel clockwise until the pin in the slot
meets the appropriate etch mark:
• 5.50 mm System – Green
Single etch line for all implants.
• 6.35 mm System – Blue
Polyaxial Screws: top etch line.
Monoaxial Screws/Open Hooks:
bottom etch line.
26
Option 1
Option 2
6.35mm
Polyaxial
Screws
Monoaxial
Screws,
Open Hooks
5.50mm
All Open
Implants
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Capture
The rod is captured into the open
implant head by turning the T-Handle
clockwise until the pin hits the opposite
side of the slot.
If resistance is felt when twisting the
T-Handle, further reduction may be
required.
Typhoon Cap Set Screw position
should be verified prior to additional
reduction attempts.
27
1
3
2
4
Retract the outer sleeve. Twist the
Approximator off of the screw with
the T-Handle.
Remove
Turn the Barrel anti-clockwise at least
three turns. Pull up on the T-Handle
until the pin hits the top of the slot.
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Attach the Rocker tips to the holding
feature on the sides of the implant head.
Lever the Rocker to fully seat the rod.
Rod Reduction – Rocker/Camlok
Cap Insertion
Align the vertical etch line on the
Cap Inserter with the etch line on
the implant head. Insert the Typhoon
Cap so that the tabs on the cap clear
the bottom of the locking tabs on the
implant head. Twist 1/8 turn clockwise
and remove the Inserter.
If resistance is felt when twisting
the Inserter, further reduction may
be required.
Typhoon Cap Set Screw position
should be verified prior to additional
reduction attempts.
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Attach the tips of the Camlok to the
holding feature on the sides of the
implant head using the lever. Turn the
reduction handle of the Camlok
clockwise until the rod is fully seated.
Cap Insertion
Align etch line of Inserter with etch line
on Camlok guide slot. Place the
Inserter through the guide slot. Insert
the Typhoon Cap so that the tabs on
the cap clear the bottom of the locking
tabs on the implant head. Twist 1/8 turn
clockwise and remove the Inserter.
If resistance is felt when twisting
the Inserter, further reduction may
be required.
Typhoon Cap Set Screw position
should be verified prior to additional
reduction attempts.
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Typhoon Cap - Compression/Distraction
Once the rod has been captured
into all of the Polyaxial Screw heads,
Compression and Distraction
manoeuvres can be easily
accomplished by simply loosening and
tightening the pre-loaded Set Screw
within the Typhoon Cap.
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Typhoon Cap Final Set Screw Tightening
Final tightening is performed with
the Hexlobe Shaft inserted into the
T-Handle Torque Wrench, which is
set to 80 in-lb (9Nm).
The shaft is then inserted through the
Open Connection Stabiliser and into
the Set Screw in the Typhoon Cap.
The Stabiliser is then slid down over
the head of the Polyaxial Screw and
onto the rod.
The T-Handle is rotated clockwise
until it clicks and resistance is no
longer evident.
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The Open Connection Stabilser is used
to prevent torsion of the construct
during final tightening.
The Torque setting handle is always set
to 80 in-lb for Set Screw tightening.
32
Typhoon Cap Set Screw Loosening
The Typhoon Cap Stabiliser should
cover the portion of implant head
above the rod but not rest directly
on top of rod.
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The Hexlobe Shaft of the Torque Wrench
Assembly is inserted through the Typhoon
Cap Stabiliser and into the Typhoon Cap
Set Screw.
The Torque Wrench Handle is set
to 80 in-lb.
The Typhoon Cap Stabiliser is then
slid down over the head of the
implant until snug. The Torque Handle
is rotated anti-clockwise until the
Set Screw is loosened.
Remove Typhoon Cap Stabiliser
and Torque Wrench Assembly.
Check to ensure Typhoon Cap
has remained in proper
“captured” orientation.
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The Hook Driver can be used in
conjunction with the Open Hook
Holder to position the Pedicle Hook.
The rod is captured into the Pedicle
Hook by inserting the Typhoon Cap.
Final tightening is performed.
Monarch™ Hooks
Pedicle Hooks
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35
Hook Site Preparation
Hook sites are chosen pre-operatively
or intra-operatively by the surgeon.
The appropriate Hook Starter is used
to prepare each selected hook site.
Closure Mechanism
See Typhoon Cap Application
(page 21).
Compression/Distraction
See Typhoon Cap Compression/
Distraction (page 30).
Final Tightening and Loosening
See Typhoon Cap Final Set Screw
Tightening and Loosening
(page 31-32).
Rod Reduction
See Rod Reduction (page 25-27).
Pedicle Hook Starter
Laminar Hook Starter
Transverse Process Hook Starter
Note: Short Cap Inserter and
Short Cap Guide are typically
recommended for Typhoon Cap
application in the Thoracic spine.
Open Hook Rules
Closed Hook Rules
Closure Mechanism
Pre-loaded Set Screw
Compression/Distraction
Compression/Distraction
maneuvers are facilitated
through interim tightening and
loosening of Set Screw.
Final Tightening and Loosening
See Slotted Connector Final Tightening
– Step 1 (page 11).
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The Hook Driver can be used in
conjunction with Open and Closed
Hook Holder to position an Open or
Closed Hook on the Transverse Process.
Open or Closed Hooks may be used
according to surgeon preference.
Closed
Ensure Closed Hook body is clear of the
Set Screw prior to insertion of the rod.
Open
The rod is captured into the Open
Hook by inserting the Typhoon Cap.
Final tightening is performed.
Transverse Process Hooks
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The Hook Driver can be used in
conjunction with the Open or Closed
Hook Holder to position an Open or
Closed Hook on the Lamina.
Open or Closed Hooks may be used
according to surgeon preference.
Closed
Ensure Closed Hook body is clear
of the Set Screw prior to insertion
of the rod.
Open
The rod is captured into the Open
Hook by inserting the Typhoon Cap.
Final tightening is performed.
Laminar Hooks
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The Offset Hook Holder may be used
to manipulate an Open Hook, reduce
the rod (with the Corkscrew) and insert
the Typhoon Cap.
Offset Hook Holder
low res
low res
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Cephalad/Caudal Hook Holder (5.50 mm only)
The Cephalad/Caudal Hook Holder
is connected to the C/C holding
features on the implant head to
avoid medial/ lateral obstruction.
A Typhoon Cap may be inserted with
the C/C Hook Holder engaged.
low res
low res
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Notes
40
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Cat No: 9081-57-000
DePuy Spine™, Monarch™ and VSP™ are trademarks and Isola® and MOSS® Miami are registered trademarks of DePuy Spine, Inc.
© 2004 DePuy International Limited. All rights reserved.
This publication is not intended for distribution in the USA
DePuy Spine™ is a joint venture with Biedermann Motech GmbH
0086
DePuy International LtdSt Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (113) 270 0461Fax: +44 (113) 272 4191