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Tubular Minimal Invasive Access System

Insight TubesSurgical Technique

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This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

Insight Tube Surgical Technique DePuy Synthes 1

Introduction Insight Tubes 2

AO Spine Principles 4

Intended Use and Indications 5

Surgical Technique Preparation 6

Surgical Technique 11

Product Information Insight Tubes 18

Instrument Sets 20

Additional Instrument Sets 22

Bibliography 23

Table of Contents

1 DePuy Synthes Insight Tube Surgical Technique

Insight Tubes

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 lum-

bar interbody fusion (TLIF/PLIF)

Advantage of Minimal Invasive Surgical (MIS) techniques:• Reduction of approach related

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

Tubular minimal invasive access

Dilator B 22 mm

Insight Tube B 22 mm, length 60 mm

Stable table fixation via Hudson Connector

Secure tube in desired position

Dark, non-glare coating

Designed to reduce glare light

Tubes made from aluminum

Radiolucent

Diameter

Wide range of sizes

Designed to increase fl exibility of working area

Length indication correlates with dilation system

For ease of selection of desired tube length


Insert dilators Insert Insight Tube Use instruments through tube

coronalaxial

sagittal


The four principles to be considered as the foundation for proper spine patient management underpin the design and delivery of the Curriculum: Stability – Alignment – Biology – Function.1,2

StabilityStabilization to achieve a specifi c therapeutic outcome

BiologyEtiology, pathogenesis, neural protection, and tissue healing

AlignmentBalancing the spine in three dimensions

FunctionPreservations and resto-ration of function to prevent disability

Copyright © 2012 by AOSpine

1 Aebi et al (1998)2 Aebi et al (2007)

AO Spine Principles


Intended Use and Indications

Intended UseInsight Tube Set is a surgical approach system. It helps in gaining access to the disc space and is used with a solid table fi xation (e.g. Flex Arm) to secure the desired posi-tion. It is designed for needs of various indications and/or surgical 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 and fusion type surgeries.

Warning: This surgical technique provides guide-lines for handling Insight Tubes only. In case the tubes are used in combination with implants or ad-ditional instruments, please refer to the respective surgical techniques for indications and contraindi-cations and specifi c surgical technique.


1. Patient positioning

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

Preparation


2. Set 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 the ease of use when working through a tubular ac-cess system, the table mounting is very important. Therefore it is recommended to always use the Insight Tubes in combination with the Synthes MIS support system which securely fixes the Insight Tubes to the OR table.

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


2a. Secure holding base

Install the holding base on the operative table by sliding in along a guide rail from the rail end. “TOP” must be visible on the clamp surface. Tighten the knob to secure it to the rail at the desired location.

Preparation


2b. Insert guiding tube into holding base

Insert a guiding tube into the holding base and lock it in place with the tightening knob.

2c. Insert flex arm bridge into guiding tube

Insert the tapered end of the flex arm bridge into the holding sleeve of the guiding tube until the desired shaft length is exposed.

Once the desired height is achieved, lock in place by us-ing the clamp handle.


2d. Attach flex arm to flex arm bridge

Slide the flex arm clamp into the flex arm bridge. Turn the clamp knob clockwise to tighten the flex arm clamp.

Note: Two flex arms may be used simultaneously on one Flex Arm – SynFrame Connection.

Flex arm tension should be fully released after each use to prevent instrument damage and allow proper instru-ment sterilization.

Preparation


1. Approach the spine

Instruments

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

02.606.003 Kirschner Wire B 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 muscle splitting within the multifidus and longissimus cleavage plane.

Determine the location of the skin incision using ana-tomic landmarks or radiographic imaging. Create an inci-sion. The incision length should match the respective tube diameter (B 16–28 mm), then cut through the sub-cutaneous tissue and make a fascial incision to the same length.

Position the Kirschner Wire in the incision and advance it carefully while controlling the position under fluoros-copy. Fix the Kirschner Wire in the bony structure where you plan to do the minimal invasive procedure.

Warning: Ensure the Kirschner Wires remain se-curely 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 pen-etrate dura or the nerve root.

Surgical Technique


2. Dilate incision

Instruments

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

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


03.610.004 Dilator B 16.0/19.0 mm for No. 03.610.003




Insert the 1.8/10.0 mm dilator over the Kirschner Wire. Continue dilation placing the 10.0/13.0 mm dilator over the 1.8/10 mm dilator. Then place the 13.0/16.0 mm dila-tor over the 10.0/13.0 mm dilator.

If a larger diameter is required continue to dilate the inci-sion by inserting dilator after dilator following the diam-eter sizes of the dilators.

Warning: Ensure the Kirschner Wire does not slip out before the tube is in place. The Kirschner Wires are long enough to be held in place by hand during soft tissue dilation.

Surgical Technique


3. Choose Insight Tube

Instruments

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





Etched markings on the dilators indicate the length of the appropriate tube. The soft tissue coverage can vary between 30 and 90 mm.


Choose the correct tube according to the last dilator. The etching of the dilator indicates the diameter of the tube and the etched ring marks indicate the length of the tube. Use the shortest allowable tube to access the posterior bony structures of the spine for uncompro-mised instrument mobility.

Surgical Technique


4. Insert Insight Tube

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

Place the tube so that the Hudson connector is pointed away from the surgeon. This allows for a wide working area and better visibility.


5. Connect 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 con-nector of the tube.

Position the tube in the desired working position and hold it in 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 de-sired position, then retighten the tension knob.

Surgical Technique


6. Remove Kirschner Wire and dilators

After securing the Insight Tube with the flexarm, the Kirschner Wire and dilators can be removed one after another.

Perform the procedure (laminectomy, discectomy, etc.) using instruments through the tube.

The rest of the surgical steps are described in the corre-sponding surgical techniques of the chosen system.


Insight Tubes

01.615.004 Insight Tubes Set

Art. No.

68.615.002 Vario Case for Insight Tubes, with Lid, without Contents

MIS Access Tubes B 16 mm

Art. No. Length

03.615.163 30 mm

03.615.164 40 mm

03.615.165 50 mm

03.615.166 60 mm

03.615.167 70 mm

03.615.168 80 mm

03.615.169 90 mm


Art. No. Length

03.615.193 30 mm

03.615.194 40 mm

03.615.195 50 mm

03.615.196 60 mm

03.615.197 70 mm

03.615.198 80 mm

03.615.199 90 mm


Art. No. Length

03.615.223 30 mm

03.615.224 40 mm

03.615.225 50 mm

03.615.226 60 mm

03.615.227 70 mm

03.615.228 80 mm

03.615.229 90 mm



Art. No. Length

03.615.253 30 mm

03.615.254 40 mm

03.615.255 50 mm

03.615.256 60 mm

03.615.257 70 mm

03.615.258 80 mm

03.615.259 90 mm


Art. No. Length

03.615.283 30 mm

03.615.284 40 mm

03.615.285 50 mm

03.615.286 60 mm

03.615.287 70 mm

03.615.288 80 mm

03.615.289 90 mm


Instrument Sets

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 B 1.8/10.0 mm, cannulated, for Guide Wire B 1.6 mm







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

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

Optional

03.809.860 Tissue Dissector


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


Additional Instrument Sets

The following sets can be used in combination with the Insight Tube access system.

Minimally Invasive Posterior Instruments (MIPI)

01.605.903 Set for MIS Posterior Instruments

The Minimally Invasive Posterior Instruments (MIPI) set is designed to facilitate discectomy, decompression and interbody work through the smaller access ports associ-ated with atraumatic posterior lumbar procedures.

For further information, please refer to surgical tech-nique DSEM/SPN/0115/0246.


Bibliography

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

Aebi M, Thalgott JS, Webb JK (1998): AO ASIF Principles in Spine Surgery. Berlin Heidelberg New York: Springer

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Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com ©

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