technique guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/llnwmb8/int mobile/synthes...

48
Transpalatal Distractor. A bone-borne modular distraction device for surgically assisted, rapid, palatal expansion. Technique Guide

Upload: others

Post on 01-Aug-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor. A bone-bornemodular distraction device for surgicallyassisted, rapid, palatal expansion.

Technique Guide

Page 2: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –
Page 3: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

Bibliography

Transpalatal Distractor 2

AO Principles 6

Intended Use, Indications and Contraindications 7

Preoperative Planning 8

Transpalatal Distractor Placement 10

Postoperative Considerations – Distraction Protocol 24

Consolidation Period 32

Transpalatal Distractor Removal 33

Implants 35

Instruments 37

Case 39

Additionally Available 40

42

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use ofthe product. Instruction by a surgeon experienced in handling this product ishighly recommended.

Reprocessing, Care and Maintenance of Synthes InstrumentsFor general guidelines, function control and dismantling of multi-part instruments,please refer to: www.synthes.com/reprocessing

Page 4: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

The Transpalatal Distractor is a modular,intraoral distraction system available inthree widths.

Right, blue footplate Distractor body = right, blue threaded pin + central body + left, gold threaded pin

Left, gold footplate

Transpalatal Distractor. A bone-bornemodular distraction device for surgicallyassisted, rapid, palatal expansion.

Transpalatal Distractor

2 Synthes Transpalatal Distractor Technique Guide

Page 5: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal distractor body– Central body with two telescopic

threaded pins– Available in three widths– Titanium alloy

Central ring for central placement andretention of activation instrument.

Open position

Closed position

The numbers 1, 2, 3 control/monitorthe distractor expansion.Arrows indicate the direction of rota-tion for distractor expansion (cranial tocaudal direction).

Three “L“ markings indicate the leftside of the patient.

Three threaded holes for blockingscrew. The blocking screw prevents dis-tractor rotation and turns the distractorfrom an expander into a retainer duringlatency and consolidation periods.

Features and Benefits

Transpalatal Distractor Technique Guide Synthes 3

TranspalatalDistractor Body

Length in ClosedPosition (mm)

Length in OpenPosition (mm)

Total DistractorExpansion (mm)

04.509.005 16 24 8

04.509.006 20 36 16

04.509.007 24 48 24

Page 6: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

��

� �

� ���

� �

Threaded pins– Left, gold– Right, blue– Contains � 0.6 mm hole for the � 0.4 mm titanium

safety wire

Footplates– Left, gold footplate to be assembled with the gold

threaded pin– Right, blue footplate to be assembled with the blue

threaded pin– Allows horizontal placement of the distractor body:

angled socket �– Easy-entry opening facilitates engagement with the

threaded pin �– Tapered edges minimize soft tissue damage and facilitate

footplate slippage under the palatal mucosa �– Large external contact surface facilitates handling with

instruments �– 2 bone screw holes � 2.1 mm, 8 mm apart �– 4 spikes located underneath footplate improve bone grip �– Etched “L” on the left, gold footplate and “R” on the

right, blue footplate for correct placement in the patient’smouth �

– Pure titanium

4 Synthes Transpalatal Distractor Technique Guide

Page 7: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Blocking screw– Blocks the left, gold threaded pin– Prevents unintentional distractor rotation– Titanium alloy

Titanium safety wires– � 0.4 mm safety wires anchor the distractor to the teeth

during the treatment period– Length 140 mm– Pure titanium

Transpalatal Distractor Technique Guide Synthes 5

Page 8: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

AO Principles

In 1958, the AO formulated four basic principles, which havebecome the guidelines for internal fixation.1

Anatomic reductionFracture reduction and fixation to restore anatomical rela-tionships.

Stable fixationFracture fixation providing absolute or relative stability, as re-quired by the “personality” of the fracture, the patient, andthe injury.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone bygentle reduction techniques and careful handling.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injuredpart and the patient as a whole.

1 M. E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger. Manual of InternalFixation, 3rd Edition. Berlin: Springer-Verlag. 1991.

6 Synthes Transpalatal Distractor Technique Guide

Page 9: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Intended Use, Indications andContraindications

Intended useThe Synthes Transpalatal Distractor is intended for use as abone-borne maxillary expander and retainer for surgically as-sisted, rapid, palatal expansion.

The Synthes Transpalatal Distractor is intended for single useonly.

IndicationsThe Synthes Transpalatal Distractor is indicated in surgicallyassisted, rapid, palatal expansion (SARPE) for correction ofmaxillary transverse deficiencies in skeletally mature patients.

ContraindicationsThe Synthes Transpalatal Distractor is not indicated for pa-tients with flat and/or scarred cleft palates.

Precaution: The hard palate cleft or alveolar cleft is likely toopen if the scar is disrupted by the distractor when used incleft maxillae with steep slopes.

Transpalatal Distractor Technique Guide Synthes 7

Page 10: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

A

B

A and B: Two possible placement options for the transpalatal distractor.

Surgical TechniquePreoperative Planning

Instruments

03.509.005 Plate Holder, curved

03.509.015 Transpalatal Distractor Sizer, L 16 mm

03.509.016 Transpalatal Distractor Sizer, L 20 mm

03.509.017 Transpalatal Distractor Sizer, L 24 mm

Determine the post-distraction anatomical goal by conduct-ing an evaluation of the craniofacial pathology through clini-cal exams, CT scan, frontal cephalogram and/or x-ray. Dentalmodels are beneficial for selecting the appropriate distractorsize, determining the location of the corticotomies andplacement of the distractor footplates.

8 Synthes Transpalatal Distractor Technique Guide

Page 11: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal distractor sizers are available for preoperativeplanning in each distractor’s closed position size: 16, 20 and24 mm.

Sizers can be used to:– Select the appropriate distractor size for the patient’s

anatomy– Determine the location of the footplate incisions– Determine the available distractor expansion

measurement

Evaluate:– Desired vector of movement and the magnitude of the

desired skeletal correction – Palatal mucosa thickness– Anatomic abnormalities of the distraction site (e.g. low

maxillary sinuses) and bone quality; especially in youngpatients, cleft patients and patient’s with edentulous maxillae

– Necessary space for distractor placement and movementof the activation instrument during the entire course oftreatment

– Surgical access for osteotomy (e.g. proximity of the inci-sors)

– Patient cooperation with device activation process andoral hygiene

Explain the treatment process to the patient before surgery,including the corticotomies, the application and functionalityof the transpalatal distractor and the time needed for thedistraction and consolidation periods.

Transpalatal Distractor Technique Guide Synthes 9

Page 12: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

10 Synthes Transpalatal Distractor Technique Guide

1Perform corticotomies

Perform the planned corticotomies for surgically assisted,rapid, palatal expansion.1, 2, 3, 4, 5

Precautions– The distractor is not designed or intended to break bone

and / or complete an osteotomy.– Avoid causing damage to the palatal blood vessels and

critical structures during progressive expansion.

Surgical Technique

Transpalatal Distractor Placement

Page 13: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 11

Assembly of the distractor body with the footplates

2Assemble transpalatal distractor

Instrument

03.509.005 Plate Holder, curved

Manually adjust the length of the threaded pins to span thepalate where the distractor placement is planned. Allow3 mm on each side for the footplate thickness.

Assemble the distractor body with both footplates. Assemblethe blue threaded pin with the blue footplate and goldthreaded pin with the gold footplate. Alternatively, matchthe left side of the main distractor body with the left foot-plate.

Precaution: Do not touch the spikes underneath the foot-plates. Handle the footplates with the plate holder includedin the set.

Note: There is a light press fit between the footplate hexa-gonal hole and the distractor threaded pins to keep the partstogether as one construct.

Page 14: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

12 Synthes Transpalatal Distractor Technique Guide

Surgical TechniqueTranspalatal Distractor Placement

3Fit transpalatal distractor

Instrument

03.509.005 Plate Holder, curved

Hold the central body with the plate holder.

Place the expanded distractor in the planned location.

Note: Expand the distractor symmetrically until the footplatespikes contact the palatal mucosa.

Place the footplates with the easy-entry openings facing an-teriorly. Place the left, gold footplate (marked “L”) on the leftside of the palate and the blue footplate (marked “R”) onthe right side of the palate.

Note: Actual placement may vary depending on the patient’sclinical situation. Be sure to consider areas where more expansion is required, i.e., parallel or V-shape expansion.

Page 15: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 13

Mark the locations of the footplate holes or of the inferiorfootplate edge on the palatal mucosa. These markings areused later as reference points for the incision lines.

Remove the distractor from the patient’s mouth.

Precautions– When possible, use the tooth roots behind the footplates

as additional reinforcement of palatal bone.– Be sure to evaluate bone quality and any anatomic abnor-

malities of the distraction site; especially in young patients,cleft patients, and patients with overdeveloped maxillarysinuses or edentulous maxillae.

– Confirm that plate positioning allows for adequate clear-ance of the tooth roots and critical structures while drillingor inserting the screws.

– Do not touch the spikes underneath the footplates. Handle the footplates with the plate holder included inthe set.

– Do not place the distractor in a location where it interfereswith the lower teeth in occlusion.

– Symmetrically expand both threaded pins so that the cen-tral body is kept in the center/midline.

– Make sure that there is sufficient space for placement offootplates and for movement of the activation instrumentduring the activation period.

Page 16: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

14 Synthes Transpalatal Distractor Technique Guide

Surgical TechniqueTranspalatal Distractor Placement

Cross-shaped mucoperiosteal incision at the level of the second premolar or firstmolar

4Make incisions for footplate placement

Mark the incision lines on the palatal mucosa using the previ-ous marks as reference points.

Make the mucoperiosteal incisions. For a cross-shaped inci-sion, use the hole marking; for a T incision, use the footplateedge marking.

Page 17: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 15

5Place footplates

Instruments

311.007 Handle, large, with Hexagonal Coupling

03.503.203 Screwdriver Shaft MatrixMIDFACE, long, self-holding, length 96 mm, with Hexagonal Coupling

03.509.240 Drill Bit � 1.1 mm, length 110/16 mm, 2-flute, for J-Latch Coupling

03.509.005 Plate Holder, curved

Disengage the distractor body from the footplate.– Use the plate holder to grab the footplate.– Slip the footplate under the mucoperiosteal flap with the

easy-entry opening facing the incisors.– Place the blue footplate marked R on the right side of the

palate.– Press the footplates into the palatal bone using finger

pressure to partially insert the spikes into the bone.

Page 18: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Surgical TechniqueTranspalatal Distractor Placement

16 Synthes Transpalatal Distractor Technique Guide

Keep the footplate in place with the plate holder and drillthrough the anterior hole in the footplate hole.

Insert the screw on the footplate without fully tightening toavoid possible screw extrusion caused by the insertion forcesof the second screw.

Page 19: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 17

Drill the posterior hole. The plate holder can be removed toimprove visibility.

Tighten the screws in an alternating fashion until they arefully inserted into the bone.

Page 20: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Surgical TechniqueTranspalatal Distractor Placement

18 Synthes Transpalatal Distractor Technique Guide

Repeat the above steps to place the gold footplate marked“L+ on the left side of the palate.

Precautions– Do not touch the spikes on the underside of the foot-

plates. Handle the footplates with the plate holder in-cluded in the set.

– Do not bend the footplates.– Confirm that plate positioning allows for adequate clear-

ance of the tooth roots and other critical structures whiledrilling or inserting the screws.

– Irrigate adequately to prevent overheating of the drill bitor the bone.

– Always use two screws with each footplate to ensure ade-quate distractor stability.

Notes– The distractor can be used alternatively as an all-in-one

device.– If the distractor is used as an all-in-one device and the

posterior screw is difficult to insert, remove the distractorbody from the footplates.

– Use the distractor as a three-piece device (footplates sepa-rate from the distractor body) if you need more room tohandle the instruments in the patient’s mouth.

– Self-drilling and self-tapping screws are available in the set.– � 1.85 mm MatrixORTHOGNATHIC screws could be used

as optional screws. See the optional screws and their� 1.4 mm drill bits on page 40.

Page 21: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 19

6Place distractor body

Instrument

03.509.005 Plate Holder, curved

Manually adjust the length of the threaded pins by rotatingthe threaded pins so that the distractor body bridges thespan between the footplate’s easy-entry openings.

Hold the central body with the plate holder and place thethreaded pins in the footplates. Assemble the blue threadedpin with the blue footplate and the gold threaded pinwith the gold footplate (or match the “L” side of the maindistractor body with the “L” footplate).

Note: If the palatal mucosa is very thick and covers thesafety wire holes of the distractor, place the safety wires inthe distractor before the distractor body is placed into thefootplates.

Precautions– Hold the central body with the front tip of the plate

holder to avoid harm to the palatal mucosa.– Place the distractor body so that the hole for the safety

wire is in a horizontally accessible position.– Symmetrically expand both threaded pins so that the cen-

tral body is kept in the center/midline.

Page 22: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Surgical TechniqueTranspalatal Distractor Placement

20 Synthes Transpalatal Distractor Technique Guide

7Confirm activation of transpalatal distractor

Instruments

03.509.002 Activation Instrument for Transpalatal Distractor

03.509.003 Patient Instrument for Transpalatal Distractor

Confirm stability of the device by verifying the pins’ insertionin the footplates.

Check that expansion takes place when the distractor centralbody is rotated from the cranial to the caudal position, as thearrows on the central body indicate.

Confirm symmetrical movement of both palatal halves.

Page 23: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 21

8Secure transpalatal distractor with safety wires

Instrument

03.509.005 Plate Holder, curved

Using the plate holder, insert a � 0.4 mm titanium safetywire in each hole of the threaded pin necks. Anchor eachside of the distractor to the teeth with the titanium safetywires.

Warning: At any time while the distractor is in the patient‘smouth, both sides of the distractor must be secured to theteeth with the safety wires in order to avoid hazard of swal-lowing or choking.

Precaution: If the palatal mucosa is very thick and coversthe safety wire holes of the distractor, place the safety wiresinto the holes before the distractor body is placed into thefootplates.

Page 24: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

22 Synthes Transpalatal Distractor Technique Guide

Surgical TechniqueTranspalatal Distractor Placement

9Lock transpalatal distractor

Instruments

03.503.203 Screwdriver Shaft MatrixMIDFACE, long, self-holding, length 96 mm, with Hexagonal Coupling

311.007 Handle, large, with Hexagonal Coupling

Remove the green blocking screw from the case with thescrewdriver blade or the blade with sleeve.

Ensure proper blade engagement with the screw recess.

Page 25: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 23

Tighten the blocking screw in one of the three holes of thecentral body until it contacts the threaded pin to preventcentral body rotation during the latency period.

Precautions– When inserting the screw, rotate the screwdriver shaft

using your fingertips. Note: The screwdriver handle is notattached to the shaft. Once the blocking screw is properlyengaged, the screwdriver handle may be mounted to theshaft to further tighten the blocking screw.

– Place gauze in the mouth to prevent ingestion in theevent the blocking screw drops from the screwdriver blade.

Notes– Maintain a clear view of the hole.– Place the blocking screw perpendicular to the distractor.

Page 26: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

24 Synthes Transpalatal Distractor Technique Guide

1Blocking screw removal

Instruments

03.503.206 Screwdriver Shaft MatrixMIDFACE, long, with Holding Sleeve, length 95 mm, with Hexagonal Coupling

311.007 Handle, large, with Hexagonal Coupling

Following the latency period, remove the green blockingscrew from the central body of the distractor with the screw-driver.

Precaution: Place gauze in the mouth to prevent ingestionin the event the blocking screw drops from the screwdriverblade.

Surgical Technique

Postoperative Considerations –Distraction Protocol

Page 27: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 25

2Suggested distraction protocol

Instrument

03.509.002 Activation Instrument for Transpalatal Distractor

Optional instrument

03.509.003 Patient Instrument for Transpalatal Distractor

Activate the device 0.33 mm per day (2 activation instrumentstrokes), after a 7 day latency period.

To open the distractor 0.33 mm, the central body must berotated in the direction of the arrows (from the cranial to thecaudal position); from one number to the next (e.g. from 1to 2, from 2 to 3 or from 3 to 1).

Follow the steps below to accomplish 0.33 mm distractor expansion.

Page 28: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Surgical TechniquePostoperative Considerations – Distraction Protocol

26 Synthes Transpalatal Distractor Technique Guide

Two instrument activations, as described below, arenecessary to expand the distractor by 0.33 mm.

A number is visible on the front surface of the distractor cen-tral body.

Hold the activation instrument by its handle and push itspivot head forward.

Center and fully engage the tip on top of the distractor cen-tral body. The instrument head has a slot that must matewith the central body ring �.

Push the activation instrument handle forward along a hori-zontal plan � � until its head comes to a stop �. The in-strument head together with the distractor central body willrotate 60˚ exposing the next distractor surface �.

Carefully slide the activation instrument downward off thedistractor central body and remove it from the mouth.

After this first activation sequence, a new distractor front sur-face is visible. This surface is not marked with a number.

Repeat the above steps to rotate the distractor central bodyand to expose the surface marked with the next number (e.g.from 1 to 2, from 2 to 3 or from 3 to 1).

The next number must be visible on the distractor front sur-face.

Page 29: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 27

Precautions– Carefully plan the rate and frequency of the distraction in

order to avoid injuries to important neurovascular struc-tures that may result from forces associated with the max-illary expansion.

– Do not force the instrument after it comes to a stop. Itshead may slip off the distractor central body causing dam-age to the soft tissue of the mouth.

– Do not activate the distractor central body in reverse dur-ing palatal distraction.

Notes– A full (360°) rotation of the central body will expand the

distractor 1 mm (e.g. the central body is rotated from 1 to1, from 2 to 2 or from 3 to 3).

– The patient activation instrument (wrench design) couldalso be used in case of unrestricted mouth opening.The head of the wrench is turned upside down after every rotation.

Page 30: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Patient Care Schedule

Physician’s Name

Physician’s Phone Number

Patient’s Name

Starting Latency Date

Next Appointment

Starting Distraction Date

Next Appointment Next Appointment

Next Appointment Next Appointment

Starting Consolidation Date

Next Appointment

Distractor Removal Date

Instructions for patientFill in the dates from the beginning of distraction through com-

pletion as instructed by your physician.

Follow the physician’s daily instructions and mark your progress

on the distraction calendar.

Follow a soft diet during the entire distraction treatment.

Maintain daily oral hygiene. Care should be taken not to acciden-

tally activate the distractor with a toothbrush or your tongue

during the distraction time.

Do not tamper the distractor with the toothbrush, tongue, finger

or any foreign object.

Keep follow-up appointments. Regular follow-up visits are essen-

tial for long-term clinical success.

Return this schedule to your physician when you have finished

distraction.

Dear Patient

You have been fitted with a distractor to gain palatal bone and

expand the dental arch. Distraction is an ongoing procedure

which requires daily activation of the distractor with a special

activation instrument.

Under instructions from your physician, you need to activate the

distractor each day.

Please follow the steps within this guide.

Should you have any nose-bleeding, missing or brokensafety wires, redness, drainage, undue pain, questions orconcerns, contact your physician immediately.

Please remember to practice good oral hygiene.

036.

001.

126

vers

ion

AA

08

/201

1 60100320

© S

ynth

es,

Inc.

or

its

aff

iliate

s Subje

ct t

o m

odific

ation

Syn

thes

is a

tra

dem

ark

of

Syn

thes,

Inc.

or

its

aff

iliate

s

Manufacturer:

Synthes GmbH

Eimattstrasse 3

CH-4436 Oberdorf

Ö036.001.126öAA}ä

Patient Care Guide.Transpalatal Distractor.

��

Daily instructions

�0.3 mm distractor expansion per day

time(s) per day

Distraction CalendarDistractor Activation

To open the distractor 0.33 mm, its central body must be rotated in

the direction of the arrow from one number to the next number

(e.g. from 1 to 2, or from 2 to 3 or from 3 to 1). Please see the pic-

tures on the next page.

Activation stepsTwo activation instrument strokes, as described below, are neces-

sary to expand the distractor by 0.33 mm.

– A number is visible on the front surface of the distractor (1, 2 or

3).

– Hold the activation instrument by its handle and push the pivot

head forward.

– Center and fully engage the instrument head on top of the cen-

tral body. The instrument head has a slot that must mate with

the central body ring �.

– Push the activation instrument handle forward along a horizontal

plane � � until its head comes to a stop �. The instrument

head together with the distractor central body will rotate expos-

ing the next distractor surface �.

– Carefully slide the activation instrument downward off the cen-

tral body and remove it from the mouth.

– After this first activation stroke, a new distractor front surface is

visible. This surface is not marked with a number.

– For the second activation stroke, repeat the above steps to rotate

the central body again and to expose the surface marked with

the next number (e.g. from 1 to 2, from 2 to 3, or from 3 to 1).

The next number must be visible on the distractor front surface.

Write down this number on the patient care guide.

You have achieved 0.33 mm expansion.

Repeat these steps as described in the daily instructions, if neces-

sary.

Note: The patient activation instrument (wrench design) could also

be used in case the mouth opening is not restricted. The instru-

ment head is turned upside down after every rotary movement.

Observe arrow direction when operating

the distractor.

MO

ND

AY

TU

ESD

AY

WED

NESD

AY

TH

URSD

AY

FRID

AY

SA

TU

RD

AY

SU

ND

AY

WEEK

1

WEEK

2

WEEK

3

WEEK

4

WEEK

5

MO

ND

AY

TU

ESD

AY

WED

NESD

AY

TH

URSD

AY

FRID

AY

SA

TU

RD

AY

SU

ND

AY

WEEK

6

WEEK

7

WEEK

8

WEEK

9

WEEK

10

MO

ND

AY

TU

ESD

AY

WED

NESD

AY

TH

URSD

AY

FRID

AY

SA

TU

RD

AY

SU

ND

AY

WEEK

11

WEEK

12

WEEK

13

WEEK

14

WEEK

15

28 Synthes Transpalatal Distractor Technique Guide

Surgical TechniquePostoperative Considerations – Distraction Protocol

3Document patient progress

Distraction progress must be observed by documenting thechanges in the intended diastema. The Patient Care Guide isincluded in the system to help the patient record and moni-tor distractor activation. This Patient Care Guide must beprovided to the patient.

Page 31: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 29

4Patient care

Accept the transpalatal distractor as a foreign body in yourmouth:– Do not tamper with, remove or activate the distractor

with the tongue, finger, toothbrush or other foreign objects.

– Comply fully with your doctor’s instructions. Regular follow-up visits are essential for long term clinical success.

– Observe arrow direction when operating the distractor.– Follow a soft diet during the entire distraction period.– Careful oral hygiene is indicated during the entire treat-

ment.

Page 32: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Surgical TechniquePostoperative Considerations – Distraction Protocol

30 Synthes Transpalatal Distractor Technique Guide

5Optional: Exchange distractor body during distractionperiod

Instruments

03.509.005 Plate Holder, curved

03.509.003 Patient Instrument for Transpalatal Distractor

It is possible to exchange the distractor body with the nextavailable size when further expansion of the maxilla is de-sired.

Rotate the distractor central body with the plate holder orpatient instrument from the caudal to the cranial positionuntil the threaded pins disengage from the footplates.

Cut the safety wires from around the teeth.

Remove the distractor body from the patient’s mouth.

Select the next size distractor body.

Repeat steps 6– 8 to place and secure the distractor in thepatient’s mouth.

Follow the distraction steps according to the distraction pro-tocol.

Warning: At any time while the distractor is in the patient’smouth, both sides of the distractor must be secured to theteeth with the safety wires.

Page 33: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 31

Precautions– Press plate holder against the footplate while removing

the threaded pin from the footplate socket to prevent ex-trusion of the bone screws.

– Hold the central body with the front tip of the plateholder to avoid harm to the palatal mucosa during rota-tion of the central body.

– Place the new distractor body so that the holes for the titanium safety wires are in a horizontally accessible posi-tion.

– Symmetrically expand both threaded pins so that the cen-tral body is kept in the center/midline.

– If the palatal mucosa is very thick and it covers the safetyholes of the distractor, place the safety wires into theholes before the distractor body is placed into the foot-plates.

Page 34: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

32 Synthes Transpalatal Distractor Technique Guide

Instruments

311.007 Handle, large, with Hexagonal Coupling

03.503.206 Screwdriver Shaft MatrixMIDFACE, long, with Holding Sleeve, length 95 mm, with Hexagonal Coupling

Once the planned expansion is accomplished, the new bonemust be given time to consolidate.

Surgical Technique

Consolidation Period

Insert the green blocking screw using the screwdriver bladewith holding sleeve and handle. The blocking screw mustcontact the threaded pin to prevent rotation during the con-solidation time.

Precaution: Place gauze in the mouth to prevent ingestionin the event the blocking screw drops from the screwdriverblade.

Notes– Allow the bone to consolidate for 12 weeks. This time

period may vary in relation to patient age and to accom-plished palatal expansion.

– Active orthodontic treatment may possibly start aftersix weeks.

Page 35: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 33

Instruments

311.007 Handle, large, with Hexagonal Coupling

03.503.206 Screwdriver Shaft MatrixMIDFACE, long, with Holding Sleeve, length 95 mm, with Hexagonal Coupling

03.503.203 Screwdriver Shaft MatrixMIDFACE, long, self-holding, length 96 mm, with Hexagonal Coupling

03.509.003 Patient Instrument for Transpalatal Distractor

03.509.005 Plate Holder, curved

Remove the green blocking screw from the distractor centralbody using the screwdriver shaft with holding sleeve andhandle.

Cut the titanium safety wires.

Remove the distractor body. Rotate the central body counter-clockwise using the plate holder or the patient instrumentuntil the threaded pins disengage from both footplates.

Surgical Technique

Transpalatal Distractor Removal

Page 36: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

34 Synthes Transpalatal Distractor Technique Guide

Remove both footplates by incising the palatal mucosa, exposing the footplates and removing the four bone screws with the long screwdriver shaft with handle.

Precautions– Hold the central body with the front tip of the plate

holder to avoid harm to the palatal mucosa during rota-tion of the central body.

– Place gauze in the mouth to prevent ingestion in theevent the blocking screw and / or the bone screws dropfrom the screwdriver blade.

Note: The timing for distractor removal should be deter-mined by clinical evaluation and radiographic or CT evidenceof bone healing (minimum 4 months).

Surgical TechniqueTranspalatal Distractor Removal

Page 37: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 35

Implants

Distractor implants

04.509.008 Blocking Screw for Implant,for Transpalatal Distractor

04.509.001 Foot Plate, right, for Transpalatal Distractor

04.509.002 Foot Plate, left, for Transpalatal Distractor

04.509.010.02 Titanium Wire, � 0.4 mm, L 140 mm,pack of 2 units

04.509.005 Transpalatal Distractor Body,16– 24 mm

04.509.006 Transpalatal Distractor Body, 20– 36 mm

04.509.007 Transpalatal Distractor Body, 24– 48 mm

Page 38: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Screws

1.5 mm MatrixMIDFACE Self-Drilling Screw, 4 in clip*

04.503.225.04C length 5 mm

04.503.226.04C length 6 mm

04.503.228.04C length 8 mm

1.5 mm MatrixMIDFACE Self-Tapping Screw, 4 in clip*

04.503.205.04C length 5 mm

04.503.206.04C length 6 mm

04.503.208.04C length 8 mm

36 Synthes Transpalatal Distractor Technique Guide

1.8 mm MatrixMIDFACE Emergency Screw, 1 in clip

04.503.235.01C length 5 mm

04.503.236.01C length 6 mm

04.503.238.01C length 8 mm

*Screws are also available in packs of 1 screw in clip. Substitute 04C with 01C inthe part number to order.

Implants

Page 39: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 37

Instruments

311.007 Handle, large, with Hexagonal Coupling

03.503.203 Screwdriver Shaft MatrixMIDFACE, long,self-holding, length 96 mm,with Hexagonal Coupling

03.503.206 Screwdriver Shaft MatrixMIDFACE, long,with Holding Sleeve, length 95 mm,

with Hexagonal Coupling

03.509.002 Activation Instrument for TranspalatalDistractor

03.509.003 Patient Instrument for TranspalatalDistractor

Page 40: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

38 Synthes Transpalatal Distractor Technique Guide

03.509.240 Drill Bit � 1.1 mm, length 110/16 mm, 2-flute, for J-Latch Coupling

03.509.280 Drill Bit � 1.1 mm, length 110/16 mm,2-flute, for Quick Coupling

03.503.248 Drill Bit � 1.1 mm with Stop, length44.5/8 mm, for J-Latch Coupling

03.503.288 Drill Bit � 1.1 mm with Stop, length44.5/8 mm, for Mini Quick Coupling

03.509.015 Transpalatal Distractor Sizer, L 16 mm

03.509.016 Transpalatal Distractor Sizer, L 20 mm

03.509.017 Transpalatal Distractor Sizer, L 24 mm

03.509.005 Plate Holder, curved, complete

Instruments

Page 41: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 39

68.509.001 Module for Transpalatal Distractor System, 2/3, with Lid, without Contents

01.509.001 Transpalatal Distractor Set

Cases

Page 42: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

40 Synthes Transpalatal Distractor Technique Guide

Additionally Available

Screws

MatrixORTHOGNATHIC Screws, Titanium Alloy (TAN)

Self-tapping screws � 1.85 mm*

04.511.205.04C length 5 mm

04.511.206.04C length 6 mm

04.511.208.04C length 8 mm

Self-drilling screws � 1.85 mm*

04.511.225.04C length 5 mm

04.511.226.04C length 6 mm

04.511.228.04C length 8 mm

Matrix screws � 2.1 mm, self-tapping

04.511.235.01C length 5 mm

04.511.236.01C length 6 mm

04.511.238.01C length 8 mm

*Screws are also available in packs of 1 screw in clip. Substitute 04C with 01C inthe part number to order.

Page 43: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 41

Drill bits

Matrix Drill Bits � 1.4 mm, for J-Latch Coupling

03.511.244 Drill Bit with Stop, length 44.5/4 mm

03.511.246 Drill Bit with Stop, length 44.5/6 mm

03.511.248 Drill Bit with Stop, length 44.5/8 mm

Matrix Drill Bits � 1.4 mm, for Mini Quick Coupling

03.511.284 Drill Bit with Stop, length 44.5/4 mm

03.511.286 Drill Bit with Stop, length 44.5/6 mm

03.511.288 Drill Bit with Stop, length 44.5/8 mm

Page 44: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

42 Synthes Transpalatal Distractor Technique Guide

Bibliography

1. Mommaerts MY. “Transpalatal distraction as a method ofmaxillary expansion.“ Br. J. Oral Maxillofac. Surg., 37 (4)(1999):268-72.

2. Pinto PX, MY Mommaerts, G Wreakes, and WV Jacobs,“Immediate postexpansion changes following the use of thetranspalatal distractor.“ J. Oral Maxillofac. Surg. 59 (9)(2001):994-1000.

3. Matteini C, MY Mommaerts. “Posterior transpalatal dis-traction with pterygoid disjunction: a short-term modelstudy.“ Am. J. Orthod. Dentofacial Orthop. 120 (5)(2001):498-502.

4. Koudstaal MJ, LJ Poort, KG van der Wal, EB Wolvius,B Prahl-Andersen, A J Schulten. “Surgically assisted rapidmaxillary expansion (SARME): a review of the literature.“Int. J. Oral Maxillofac. Surg. 34 (7) (2005):709-14.

5. Suri L, P Taneja. “Surgically assisted rapid palatal expan-sion: a literature review.“ Am. J. Orthod. Dentofacial Orthop.133 (2) (2008): 290-302.

Page 45: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

Transpalatal Distractor Technique Guide Synthes 43

Page 46: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

44 Synthes Transpalatal Distractor Technique Guide

Page 47: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –
Page 48: Technique Guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · of the activation instrument during the entire course of treatment –

0123All technique guides are available as PDF files at www.synthes.com/lit

Ö036.001.125öAArä

036.

001.

125

vers

ion

AA

08

/201

160

0800

26

© S

ynth

es, I

nc. o

r its

aff

iliat

es

Subj

ect

to m

odifi

catio

n Sy

nthe

s is

a t

rade

mar

ks o

f Sy

nthe

s, In

c. o

r its

aff

iliat

es