Insight Tubes. Tubular minimal invasiveaccess system.

Technique Guide

Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

Insight Tubes 2

AO Principles 4

Intended Purpose and Indications 5

Preparation 6

Surgical Technique 8

Insight Tubes 15

Instrument Sets 17

Additional Instrument Sets 19

Image intensifier control

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

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

2 Synthes Insight Tube Technique Guide

The Insight Tube system allows to accomplish the goals of an open procedure in minimal space withreduced tissue damage.

The system can be used for:– Discectomy– Laminectomy– Transforaminal or posterior lumbar

interbody fusion (TLIF/PLIF)

Insight Tubes. Tubular minimalinvasive access system.

Advantage of Minimal InvasiveSurgical (MIS) techniques:– Reduction of approach related

morbidity– Reduced blood loss– Improved recovery time– Reduced scarring– Shorter hospital stay

Stable table fixation via Hudson Connector

Secure tube in desired position

Dark, non-glare coating

Reduced glare light

Tubes made from aluminum

Radiolucent

Diameter

Wide range of sizes

Increases flexibility of working area

Length indication correlates with dilationsystem

Easier selection of desired tube length

Tubular minimal invasive access

Dilator � 22 mmInsight Tube � 22 mm,length 60 mm

Synthes 3

Insert dilators Insert Insight Tube Use instruments through tube

4 Synthes Insight Tube Technique Guide

AO Principles

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

– Anatomical reduction– Stable internal fixation– Preservation of blood supply– Early, active pain-free mobilization

The fundamental aims of fracture treatment in the limbsand fusion of the spine are the same. A specific goal in thespine is returning as much function as possible to theinjured neural elements. 2

AO Principles as applied to the spine3

Anatomical alignmentRestoration of normal spinal alignment to improve the biomechanics of the spine.

Stable internal fixationStabilization of the spinal segment to promote bony fusion.

Preservation of blood supplyCreation of an optimal environment for fusion.

Early, active mobilizationMinimization of damage to the spinal vasculature, dura,and neural elements, which may contribute to pain reductionand improved function for the patient.

1Müller ME, Allgöwer M, Schneider R, Willenegger H (1995) Manual of InternalFixation. 3rd, expanded and completely revised ed. 1991. Berlin, Heidelberg,New York: Springer

2Ibid.3Aebi M, Arlet V, Webb JK (2007) AOSPINE Manual (2 vols), Stuttgart, New York: Thieme

Synthes 5

Intended Purpose and Indications

Intended PurposeInsight Tube Set is a surgical approach system. It helps ingaining access to the disc space and is used with a solidtable fixation (e.g. Flex Arm) to secure the desired position.It is designed for needs of various indications and/or surgi-cal techniques.

The system can be used for:– Discectomy– Laminectomy– Transforaminal or posterior lumbar

interbody fusion (TLIF/PLIF)

IndicationsThe system is indicated to be used with interbody fusion devices and instruments that allow for decompression andfusion type surgeries.

Warning: This technique guide provides guidelines for handling Insight Tubes only. In case the tubes are used incombination with implants or additional instrumentsplease refer to the respective technique guides for indicationsand contraindications and specific surgical technique.

6 Synthes Insight Tube Technique Guide

1Patient positioning

The patient is placed in a prone position. To facilitate in in-tra operative exposure of the posterior disc space, the spinecan be flexed.

Preparation

Synthes 7

2Set up MIS Support System

MIS Support System

387.346 SynFrame Holding Base, insulated, for OR Table, dark blue

387.343 SynFrame Guiding Tube, for Angled Rod No. 387.344, for Basic System

03.612.012 Flex Arm – SynFrame Connection

03.612.010 Flex Arm

For instructions please follow the assembly guide036.000.248.

For the ease of use when working through a tubular accesssystem, the table mounting is very important. Therefore itis recommended to always use the Insight Tubes in combina-tion with the Synthes MIS support system which securelyfixes the Insight Tubes to the OR table.

Note: Two flex arms may be used simultaneously on theFlex Arm – SynFrame Connection for bilateral approaches.

8 Synthes Insight Tube Technique Guide

1Approach the spine

Instruments

02.606.001 Kirschner Wire � 1.6 mm with trocar tip, length 480 mm, Stainless Steel

02.606.003 Kirschner Wire � 1.6 mm without trocar tip, length 480 mm, Stainless Steel

The mini-open approach uses paramedian incision made through the skin and fascia approximately 2 – 3 cm (for PLIF)or 3 – 4 cm (for TLIF) from the midline. This allows musclesplitting within the multifidus and longissimus cleavage plane.

Determine the location of the skin incision using anatomiclandmarks or radiographic imaging. Create an incision. The incision length should match the respective tube diame-ter (� 16 –28 mm), then cut through the subcutaneous tissue and make a fascial incision to the same length.

Position the Kirschner wire in the incision and advance itcarefully while controlling the position under fluoroscopy. Fixthe Kirschner wire in the bony structure where you plan todo the minimal invasive procedure.

Warning: Ensure the Kirschner wires remain securely in position throughout the entire duration of the procedure.The tip of the Kirschner wire should be monitored by fluoroscopy to ensure it does not slip off the bony structures(e.g. facet joint) and penetrate dura or the nerve root.

Surgical Technique

Synthes 9

2Dilate incision

Instruments

03.610.001 Dilator � 1.8/10.0 mm, cannulated, for Guide Wire � 1.6 mm

03.610.002 Dilator � 10.0/13.0 mm, for No. 03.610.001

03.610.003 Dilator � 13.0/16.0 mm, for No. 03.610.002

03.610.004 Dilator � 16.0/19.0 mm for No. 03.610.003

03.610.005 Dilator � 19.0/22.0 mm for No. 03.610.004

03.610.006 Dilator � 22.0/25.0 mm for No. 03.610.005

03.610.007 Dilator � 25.0/28.0 mm for No. 03.610.006

Insert the 1.8/10.0 mm dilator over the Kirschner wire. Continue dilation placing the 10.0/13.0 mm dilator over the1.8/10 mm dilator. Then place the 13.0/16.0 mm dilatorover the 10.0/13.0 mm dilator.

If a larger diameter is required continue to dilate the incisionby inserting dilator after dilator following the diameter sizesof the dilators.

Warning: Ensure the Kirschner wire does not slip out beforethe tube is in place. The Kirschner wires are long enoughto be held in place by hand during soft tissue dilation.

10 Synthes Insight Tube Technique Guide

3Choose Insight Tube

Instruments

03.615.163 – 169 MIS Access Tube, size 16�30 mm – 16�90 mm

03.615.193 – 199 MIS Access Tube, size 19�30 mm – 19�90 mm

03.615.223 – 229 MIS Access Tube, size 22�30 mm – 22�90 mm

03.615.253 – 259 MIS Access Tube, size 25�30 mm – 25�90 mm

03.615.283 – 289 MIS Access Tube, size 28�30 mm – 28�90 mm

Etched markings on the dilators indicate the length of theappropriate tube. The soft tissue coverage can vary between30 and 90 mm.

Surgical Technique

Synthes 11

Choose the correct tube according to the last dilator. Theetching of the dilator indicates the diameter of the tube andthe etched ring marks indicates the length of the tube.Use the shortest allowable tube to access the posterior bonystructures of the spine for uncompromised instrument mobility.

12 Synthes Insight Tube Technique Guide

4Insert Insight Tube

The selected Insight Tube is inserted over the last dilator andpushed down.

Place the tube so that the Hudson connecter is pointed awayfrom the surgeon. This allows for an unlimited working areaand better visibility.

Surgical Technique

Synthes 13

5Connect Insight Tube to the flex arm

Connect the tube with the flex arm by pulling back the coupling on the flex arm and plug in the Hudson connectorof the tube.

Position the tube in the desired working position and hold itin place.

Turn the tension knob on the flex arm until it is secured.

To reposition the tube, release the flex arm tension by turning the tension knob back. Place the tube in the desiredposition, then retighten the tension knob.

14 Synthes Insight Tube Technique Guide

6Remove K-wire and dilators

After securing the Insight Tube with the flexarm, the K-wireand dilators can be removed one after another.

Perform the procedure (laminectomy, discectomy, etc.) us-ing instruments through the tube.

The rest of the surgical steps are described in the correspon-ding technique guides of the chosen system.

Surgical Technique

Synthes 15

01.615.004 MIS Access Tube Set, complete

Art. No.

68.615.002 Vario Case for MIS Access Tubes

Insight Tubes

Art. No. Length

03.615.163 30 mm

03.615.164 40 mm

03.615.165 50 mm

03.615.166 60 mm

Art. No. Length

03.615.167 70 mm

03.615.168 80 mm

03.615.169 90 mm

MIS Access Tubes � 19 mm

Art. No. Length

03.615.193 30 mm

03.615.194 40 mm

03.615.195 50 mm

03.615.196 60 mm

Art. No. Length

03.615.197 70 mm

03.615.198 80 mm

03.615.199 90 mm

MIS Access Tubes � 22 mm

Art. No. Length

03.615.223 30 mm

03.615.224 40 mm

03.615.225 50 mm

03.615.226 60 mm

Art. No. Length

03.615.227 70 mm

03.615.228 80 mm

03.615.229 90 mm

MIS Access Tubes � 16 mm

16 Synthes Insight Tube Technique Guide

MIS Access Tubes � 25 mm

Art. No. Length

03.615.253 30 mm

03.615.254 40 mm

03.615.255 50 mm

03.615.256 60 mm

Art. No. Length

03.615.257 70 mm

03.615.258 80 mm

03.615.259 90 mm

MIS Access Tubes � 28 mm

Art. No. Length

03.615.283 30 mm

03.615.284 40 mm

03.615.285 50 mm

03.615.286 60 mm

Art. No. Length

03.615.287 70 mm

03.615.288 80 mm

03.615.289 90 mm

Insight Access Tubes

Synthes 17

01.809.011 Dilation Instrument Set

Vario Case

68.615.003 Vario Case for Dilation Instruments, with Lid, without Contents

Instruments

03.610.001 Dilator � 1.8/10.0 mm, cannulated, for Guide Wire � 1.6 mm

03.610.002 Dilator � 10.0/13.0 mm, for No. 03.610.001

03.610.003 Dilator � 13.0/16.0 mm, for No. 03.610.002

03.610.004 Dilator � 16.0/19.0 mm for No. 03.610.003

03.610.005 Dilator � 19.0/22.0 mm for No. 03.610.004

03.610.006 Dilator � 22.0/25.0 mm for No. 03.610.005

03.610.007 Dilator � 25.0/28.0 mm for No. 03.610.006

02.606.001 Kirschner Wire � 1.6 mm with trocar tip, length 480 mm, Stainless Steel

02.606.003 Kirschner Wire � 1.6 mm without trocar tip, length 480 mm, Stainless Steel

Optional

03.809.860 Tissue Dissector

For further information please refer to technique guide036.001.005.

Instrument Sets

18 Synthes Insight Tube Technique Guide

Instrument Sets

MIS Support System

Vario Case

68.616.012 Vario case for MIS Support System

Instruments

387.346 SynFrame Holding Base, insulated, for OR Table, dark blue

387.343 SynFrame Guiding Tube, for Angled Rod No. 387.344, for Basic System

03.612.012 Flex Arm – SynFrame Connection

03.612.010 Flex Arm

Optional

03.612.031 Fibre Optic Cable for Light Strip

For further information please refer to technique guide036.000.248.

Synthes 19

Additional Instrument Sets

Following sets can be used in combination with the InsightTube access system.

Minimally Invasive Posterior Instruments (MIPI)

01.605.903 Set for Minimally Invasive Posterior Instruments

The Minimally Invasive Posterior Instruments (MIPI) set is de-signed to facilitate discectomy, decompression and interbodywork through the smaller access ports associated with atraumatic posterior lumbar procedures.

For further information please refer to technique guide036.000.465.

OPAL (Oblique Posterior Atraumatic Lumbar)

01.803.105 OPAL Instrument Set in Vario Case

OPAL is an implant system for an unilateral transforaminalapproach (TLIF). The design of the OPAL cage allows for selfdistraction.

The cage can be inserted with two different surgical techniques. The instruments are designed for minimally invasive surgeries.

For further information please refer to technique guide036.000.947.

20 Synthes Insight Tube Technique Guides

Additional Instrument Sets

Following sets can be used after removing of the tube andon the contralateral site.

SpiRIT

01.631.001 SpiRIT Set in Vario Case

01.631.005 SpiRIT Additional Instruments in Vario Case

01.631.004 MIS-Rods, radius 200 mm in Vario Case

01.624.004 Additional Pedicle Screws Pangea Polyaxial in Vario Case

SpiRIT is designed to minimize soft tissue trauma by using atransmuscular approach and subfacial rod insertion for thoracolumbar pedicle fixation.

For further information please refer to technique guide036.000.987.

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