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> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography Step by Step Description of the TESSYS ® Technique Product Usage Guide joimax ® Product Usage Guide · 08_2009 · PUGTEEN · Printed on chlorine-free paper · Vegetable-based colors were used for printing Literature 1. Darzi A, Mackay S; Recent Advances in Minimal Access Surgery. In: BMJ, Vol 324, pp 31-34, 2002 2. Krzok G; Early Results after Posterolateral Endoscopic Discectomy with Thermal Annuloplasty. In: Program Abstract at the 17th Annual Meeting of the International Intradiscal Therapy Society, Munich, 2004 3. Levinkopf M, Caspi I et al; Posterolateral Endoscopic Discectomy. In: Program Abstract at the 18th Annual Meeting of the International Intradiscal Therapy Society, San Diego, 2005 4. Iprenburg M; Percutaneous Transforaminal Endoscopic Discectomy; The Learning Curve to Achieve a more than 90% Success Rate. In: Program Abstract at the 19th Annual Meeting of the International Intradiscal Therapy Society, Phoenix, 2006 5. Alfen FM; Lauerbach B; Ries W; Developments in the Area of Endoscopic Spine Surgery. In: European Musculoskeletal Review, 2006 6. Schubert M, Hoogland T; Endoscopic Transforaminal Discectomie for Recurrent Lumbar Disc Herniation. In: SPINE Volume 33, Number 9, 2008 7. AWMF Online, „Leitlinien der Deutschen Gesellschaft für Neurochirurgie“ Iprenburg M; Transforaminal Endoscopic Surgery – Technique and Provisional Results in Primary Disc Herniation. In: European Musculoskeletal Review, Issue 2, 2007 Lewandrowski KU; Yeung CA; Spoonamore MJ; McLain RF; Minimally Invasive Spinal Fusion Techniques, 2008 Iprenburg M, Godschalx A; Transforaminal Endoscopic Surgery in Lumbar Disc Herniation in an Economic Crisis – The TESSYS Method. In: US Musculoskeletal Review, 2008 joimax ® GmbH An der RaumFabrik 33a, Amalienbadstraße 36 76227 Karlsruhe - Germany PHONE +49 (0) 721 255 14-0 FAX +49 (0) 721 255 14-920 MAIL [email protected] NET www.joimax.com joimax ® , Inc. 275 E. Hacienda Avenue Campbell, CA 95008 USA PHONE +1 408 370 3005 FAX +1 408 370 3015 MAIL [email protected] NET www.joimaxusa.com This document contains information protected by copyright and property law and may not be copied in full or in parts thereof or transferred to a further medium in any form. Distribution to third parties is prohibited. joimax ® , Vitegra ® , Camsource ® , TESSYS ® , iLESSYS TM , CESSYS TM , Legato TM , Shrill TM and SPOT TM are registered brands of joimax ® . Other products and names used here may be the registered brands of other companies. Patents are registe- red. Copyright ® 2009 joimax GmbH. All rights reserved. CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

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Page 1: Product Usage Guide - Lindare Medical Ltdlindaremedical.co.uk/wp-content/uploads/2017/07/joimax_OPB_EN_l… · Disc Herniation. In: SPINE Volume 33, Number 9, 2008 7. AWMF Online,

> Fragmentectomy> Foraminoplasty> Decompression> Nucleotomy> Annuloplasty> Discography

Step by Step Description of theTESSYS® Technique

Product Usage Guide

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Literature

1. Darzi A, Mackay S; Recent Advances in Minimal Access Surgery. In: BMJ, Vol 324, pp 31-34, 20022. Krzok G; Early Results after Posterolateral Endoscopic Discectomy with ThermalAnnuloplasty. In: Program Abstract at the 17th Annual Meeting of the InternationalIntradiscal Therapy Society, Munich, 20043. Levinkopf M, Caspi I et al; Posterolateral Endoscopic Discectomy. In: Program Abstract at the 18th Annual Meeting of the International Intradiscal Therapy Society, San Diego, 20054. Iprenburg M; Percutaneous Transforaminal Endoscopic Discectomy; The Learning Curve toAchieve a more than 90% Success Rate. In: Program Abstract at the 19th Annual Meeting of the International Intradiscal Therapy Society, Phoenix, 2006 5. Alfen FM; Lauerbach B; Ries W; Developments in the Area of Endoscopic Spine Surgery.In: European Musculoskeletal Review, 20066. Schubert M, Hoogland T; Endoscopic Transforaminal Discectomie for Recurrent LumbarDisc Herniation. In: SPINE Volume 33, Number 9, 20087. AWMF Online, „Leitlinien der Deutschen Gesellschaft für Neurochirurgie“

Iprenburg M; Transforaminal Endoscopic Surgery – Technique and Provisional Results in Primary Disc Herniation. In: European Musculoskeletal Review, Issue 2, 2007

Lewandrowski KU; Yeung CA; Spoonamore MJ; McLain RF; Minimally Invasive Spinal Fusion Techniques, 2008

Iprenburg M, Godschalx A; Transforaminal Endoscopic Surgery in Lumbar Disc Herniationin an Economic Crisis – The TESSYS Method. In: US Musculoskeletal Review, 2008

joimax® GmbHAn der RaumFabrik 33a, Amalienbadstraße 3676227 Karlsruhe - GermanyPHONE +49 (0) 721 255 14-0FAX +49 (0) 721 255 14-920MAIL [email protected] www.joimax.com

joimax®, Inc.275 E. Hacienda AvenueCampbell, CA 95008 USA

PHONE +1 408 370 3005FAX +1 408 370 3015MAIL [email protected] www.joimaxusa.com

This document contains information protectedby copyright and property law and may not becopied in full or in parts thereof or transferredto a further medium in any form. Distributionto third parties is prohibited. joimax®,Vitegra®, Camsource®, TESSYS®, iLESSYSTM,CESSYSTM, LegatoTM, ShrillTM and SPOTTM areregistered brands of joimax®. Other productsand names used here may be the registeredbrands of other companies. Patents are registe-red. Copyright ® 2009 joimax GmbH. All rights reserved.

CAUTION: U.S. FEDERAL LAW RESTRICTSTHIS DEVICE TO SALE BY OR ON THE ORDEROF A PHYSICIAN

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Product Usage Guide CONTENT Product Usage Guide EDITORIAL

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography32

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CONTENTS

EDITORIAL

CONCEPT

INDICATIONS

STEP 1

STEP 2

STEP 3

STEP 4

STEP 5

STEP 6

STEP 7

STEP 8

STEP 9

STEP 10

STEP 11

ANAESTHESIA RECOMMENDATION

LITERATURE

Note: For TESSYS® beginners we recommend focusing on the treat-ment of L3-L4 and L4-L5 disc hernias. Cranial or caudal sequestered hernias or free fragments are not the best indications to start with, asthe TESSYS® method – like all new surgical techniques - has a learningcurve dependent on the surgeon.

The use of endoscopic surgery on a daily basis began in the 1980s in the fields of laparoscopy andarthroscopy. In the 1990s endoscopic and minimally invasive neuro and cardiac surgery followed [1].Evolution of these technologies has made more sophisticated and targeted applications possible, and as a result endoscopic spine surgery has become a reality.

“Endoscopic techniques may speed recovery, minimize postoperative pain and improve the finaloutcome. What once required 3 to 6 months to recover from now only requires 3 to 6 weeks!“

The Cleveland Clinic Foundation

Acknowledgments:The pictures and documentation material shown in this product usage guide are acompilation of different types of L3-L4, L4-L5 and L5-S1 disc herniations, courtesy of Dr. Guntram Krzok, Dr. Florian Maria Alfen, Dr. Michael Schubert, Dr. Rudolf Morgenstern,Dr. Menno Iprenburg, Prof. Dr. Jürgen Kiwit, Dr. Moshe Levinkopf and Dr. Kai-UweLewandrowski.

Sincere thanks are given to them all.

(l-r): Dr. Guntram Krzok (Friedrichroda, Germany), Dr. Florian Maria Alfen (Würzburg, Germany), Dr. Rudolf Morgenstern (Barcelona, Spain), Dr. Menno Iprenburg (Veenhuizen, Netherlands), WolfgangRies (Founder & President joimax®, Germany). Not shown in picture: Dr. Michael Schubert (Munich,Germany), Prof. Dr. Jürgen Kiwit (Berlin, Germany), Dr. Moshe Levinkopf (Tel Aviv, Israel), Dr. Ralf Wagner(Frankfurt, Germany) and Dr. Alexander Godschalx (Veenhuizen, Netherlands).

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> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography

Product Usage Guide CONCEPT Product Usage Guide INDICATIONS

54

Surgical Indications

The TESSYS® method can be used to remove almost all herniated discs and sequesters – irre-spective of their position – through the lateral, transforaminal access under analgesic sedation.

The TESSYS® surgery is indicated for all radicular symptoms caused by herniated discs thatcannot be improved by conservative therapeutical methods. Cauda equina syndrome indicatesimmediate grounds for surgery. Every surgical procedure on a spinal disc, including the TESSYS® surgery, has to be carefully prepared by using Magnetic Resonance Imaging (MRI)and/or computer tomography (CT), as well as multiple conventional x-ray images.

Intraoperative discography and chromography provide final certainty in the accurate determi-nation of the herniated disc position. They are conducted using the needle included in the TESSYS® disposable set.

X-ray: lateral

MRI: L3-L4 and L4-L5 lateral

MRI: L5-S1 lateral MRI: L5-S1 axial

MRI: L4-L5 lateral and axial44 year old female: radicular pain for 5 months

MRI: L4-L5 lateral

X-ray: AP

The TESSYS® Concept

The TESSYS® procedure utilizes a lateral, transforaminal, endoscopic approach for the removalof herniated intervertebral disc material, resulting in a less traumatic approach for the patientthan the usual dorsal approach. With the TESSYS® technique, sequestered disc material isremoved completely and directly through the foramen, which is gradually widened using specialized reamers and instruments. The patient can be placed in either the prone or lateralposition, and is awake during the entire operation, which is carried out under local anaesthesia.This allows communication with the patient throughout the entire procedure. [2, 3, 4, 5, 6]

55°- 65°

Lateral view

60°

30°- 40°

40°- 50°

25°- 35°

35°

45°

30°

Dorsal view

10 -14 cm

10°- 40°

Axial view

Entry Point

25°

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Product Usage Guide INDICATIONS Product Usage Guide INDICATIONS

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography76

Lumbar Disc HerniationDefinition: Irritation or compression of the lumbar / sacral nerve roots, lumbar spinal nerves or cauda equina byintra-/extraforaminal extruded disc tissue in the spinal canal

Diagnostic- History - Clinical neurological findings- Labs

Neurological deficits, strong pain, resistance to therapy?

Conservative therapy- Pain medication- Non steroidal antiphlogistica- Cortisone / corticosteroids

Imaging techniques- MRI- Lumbar CT- Radiography and dynamic

imaging if needed

If medical imaging available:- Peridural / periradicular

therapy if required

Severe deficits (paresis, caudaequina syndrome), resistance totherapy, excruciating pain?

Amelioration?

Imaging for surgery adequate?

Surgery- Microsurgical discectomy- Standard discectomy- Percutaneous / endoscopic

techniques- Sequestrectomy

Postoperative treatment- Physical therapy- Medical strengthening therapy

for back pain- Painkillers, NSA if necessary

Additional imaging- Myelography- Myelo-CT

Patient requires no additional treatmentStable amelioration?

Clinical Algorithm [7]Schematic illustration of the relation betweenthe localisation of a L4-L5 hernia and its corresponding neural compression

Whilst a medial prolapse in L4-L5 (pos. 1) compresses the dura mater and lower nerve roots,a medio-lateral prolapse affects the nerve roots of L5 (pos. 2). An intra- or extraforaminallylocated prolapse (pos. 3) compresses the L4 root. The L4 root can also be affected by a more cranially located prolapse (pos. 4). Rarely, in the case of a far caudal dislocated hernia, theroot of S1 can become compressed (pos. 5). [7]

no

yes

no

no

no

no

yes

yes

yes

yes

Fig. A:Axial view

Fig. B:Dorsal view

13 2

1

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3

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5

L4

L5

S1

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The Preoperative Planing

STEP 1

When accessing with TESSYS® instruments and cutters, observe the herniated disc’s clearposition. Sagittal and axial MRT images are required for determination of the herniated disc’sexact location. A lateral x-ray of the spine is also required to determine the size of the foramen and the height of the iliac crest, especially for L5-S1 access.

The selection of the lateral access distance from the spinal process line depends on the size ofthe intervertebral foramen and the patient’s physique. An access of approximately 10 cm fromthe center line is sufficient for existing large foramens, as is usually the case in levels L2-3 andL3-4. Levels L4-5 and L5-S1 can usually be approached laterally 12-14 cm from the midline fora normal sized foramen. Select an appropriately larger distance from the spinal process line forobese patients or a very narrow foramen. Experience has shown that caudally positioned herniated discs should be approached from a more cranial and lateral access point.

Product Usage Guide STEP 1 Product Usage Guide STEP 2

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography98

Stable lateral positioning

Prone positioning

The Positioning & Fluoroscopy

STEP 2

A TESSYS® operation can be performed in the prone or lateral position. The former is generallyknown and will not be described in detail at this point.

Lateral PositionPosition the patient laterally on the operating table with the treatable side facing upwards.Support the waist with a cushion roll. Position the patient’s legs at an angle to achieve desi-red straightening of the lumbar spine. Then disinfect and aseptically cover the patient’s back.Use the image converter to display the treatable vertebra segments at two levels.

AnaesthesiaPlease read through our anaesthesia scheme (page 27), which is used in many reference centers.

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Product Usage Guide STEP 3 Product Usage Guide STEP 3

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography1110

Access Planning

STEP 3

Following the preparation of the operation area, cover the patient with the sterile joimax®

patient isolation drape.

Mark the spinal process line (center line) and then the iliac crest line (fig. 1). To reach level L5-S1,the lateral distance (distance line) is 12-14 cm from the center line to the access point (fig. 3).Now position a long instrument (e.g. alligator forceps) in the C-arm’s lateral path of rays, levelto the herniated disc (fig. 3-5). Once this position is accurately met, mark it (directional line).The intersection made up of the horizontal distance line, the diagonal directional line and theiliac crest line results in the access point (fig. 6).

> Marker> 18 G Needle> 21 G Needle> 2 ml, 5 ml and 2 x 10 ml Syringes> 20 G and 27 G Injection Needles> 3 x 90 ml Dishes (Contrast medium,

NaCl, drugs)> 2 Guide Wires (0.7 mm x 400 mm)> Scalpel

> Reamer – coarse, dark red 7.5 mm> Reamer – fine, light red 7.5 mm> Reamer – coarse, dark yellow 6.5 mm> Reamer – fine, light yellow 6.5 mm> Reamer – coarse, dark green 5.0 mm> Reamer – fine, light green 5.0 mm> Sealing Cap for Foraminoscopes> Suture

TESSYS® Disposable Access Kits:The TESSYS® Disposable Access Kits include all single use items and materials for a successfulTESSYS® surgery.

1

3

5 6

4

2

The Kit includes the following components:

> Steel ruler> Endoscopic Forceps

> MarkerThe following instruments and components are necessary for this step:

TESSYS® Instrument Set TESSYS® Disposable Access Kit

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Product Usage Guide STEP 4 Product Usage Guide STEP 4

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography1312

The Discography / Chromography*

STEP 4

Now perform a discography. It serves differential diagnostic purposes, but also determines theextent of the annulus rupture. Anaesthetize the skin and muscles with approx. 5 ml Xylocainand additional adrenalin (local anaesthesia). Use the 18 G access needle to puncture theposterior lateral disc segment diagonally at an angle of approx. 60° via the isthmus throughthe neuroforamen (fig. 1). Now use the 21 G needle, inserted through the previously positio-ned 18 G needle, to puncture the herniated disc (fig. 2-4). Inject approx. 2 ml contrast agent,mixed with indigo carmine, through the thin 21 G needle into the disc to make the pathologyfully visible (fig. 5-8).

*Note: A chromography is a discography whereby indigo carmine is added to the contrast agent to color the disc (blue-green).

> 18 G Needle> 21 G Needle> Syringes

> 20 G and 27 G Injection Needles> Dishes (contrast medium, NaCl, drugs)

1

3

5

7

6

8

4

2

The following components are necessary for this step:

The 5 types of discogram (classification by Adams MA et al.)

1. Cottonball 2. Lobular 3. Irregular 4. Fissured 5. Ruptured

TESSYS® Disposable Access Kit

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Product Usage Guide STEP 5 Product Usage Guide STEP 5

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography1514

Placement Guiding Rod I (green)

STEP 5

Now push the first 18 G access needle further over the reclining second 21 G needle. Retract thethin 21 G discography needle and replace it with one of the two guide wires. Finally, retract thefirst 18 G needle. The guide wire remains in position (fig. 1)!

Use the scalpel to open the puncture point to no more than 1 cm. Attention: The patient’s covering foil should be cut out slightly around the puncturepoint for the reaming procedure.

Now push the guiding rod (green) over the guide wire up to the facet joint (fig. 3-5). The specialguiding rod I (green) with its curved tip is often advantageous for L5-S1 (fig. 7-8). To dilate thesoft tissue, advance the three guiding tubes I/II/III (green/yellow/red) with increasing diametersover the guiding rods (fig. 6). You can optionally use the 21 G discography needle, whose tip is angled with the needle holder,to infiltrate the facet joint between guiding rod I (green) and guiding rod III (red). A double-canulated guiding rod is also available, offering a further infiltration option. Finally, remove guiding rods II (yellow) and III (red).

Traffic Light Principle

The TESSYS® System uses the recognized world wide traffic light sequence as a reference guide.Red: Beware, you are working very close to the nerve!Yellow: Caution, you are approaching the nerve!Green: Safe, you are working at a safe distance from the nerve!

> Guiding Rod – green (straight/curved)> Guiding Rod Forceps> Guiding Tubes – green, yellow and red

> 2 Guide Wires> Scalpel

1

3

5

7

6

8

4

2

The following instruments and components are necessary for this step:

TESSYS® Instrument Set TESSYS® Disposable Access Kit

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Product Usage Guide STEP 6 Product Usage Guide STEP 6

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography1716

First Reamer I (light green fine or dark green course)

STEP 6

Rotate the crown reamer I (green fine or coarse / 5.0 mm) over the guiding rod I (green) andthe guiding tube I (green), (fig. 1 and 2). Now remove the facet joint isthmus bone undermedialisation in the direction of the herniated disc in order to expand the neuroforamen.

Reaming principle:

All guiding rods, guiding tubes, disposable reamers and reamer ejectors are color-coded accor-ding to the Traffic Light Principle: green-yellow-red (page 14). The blue reamer (4.0 mm, inkits 5 and 7) will be required for very narrow foramina. The toothing of the crown reamer isdesigned in such a way that no soft tissue is caught or trapped while inserting the reamercounter-clockwise. The reamer should be turned clockwise as soon as it comes into contactwith bone. Optimal analgesia is crucial for this part of the procedure. The endo-reamer serves to remove bone tissue under constant endoscopic view. It is insertedthrough the working channel after positioning the foraminoscope.Figures 3 and 4 display the position of the crown reamer over the guiding rod and the guidingtube. The position of the instruments and the reaming process are monitored with a.p. lateralcontrol x-rays. Ensure the guiding rod tip is positioned directly against the vertebral body’s toppanel in the lateral view (depending on the position of the prolapse) and simultaneously in thecenter of the spinal canal during a.p. x-ray.

Reaming depth border line:

The crown reamers should never be turned deeper than up to the medial interpedicular line(fig. 8).

> Guiding Rod – green> Guiding Tube – green> Reamer Ejector – green

> Reamer – green> Handle for Reamer

1

3

5

7

6

8

4

2

The following instruments and components are necessary for this step:

=̂ =̂

TESSYS® Instrument Set TESSYS® Disposable Access Kit

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Product Usage Guide STEP 7 Product Usage Guide STEP 7

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography1918

Second Reamer (light yellow fine or dark yellow coarse)

STEP 7

To secure the position of the guide wire, push the blunt guiding rod (green) as counter-supportfor the conical guiding rod I (green) over the guide wire. Now carefuly unscrew the first crownreamer with guiding tube I (green) in a counter-clockwise direction. Remove both the blunt andthe conical guiding rod I. Now use the guide wire to bring the second conical guiding rod II (yel-low) into the desired position (fig. 1-3). If required, use the hammer to gradually advance theguiding rod. The guiding tube II (yellow) is passed over the guiding rod II (yellow, fig. 4), follo-wed by the crown reamer II (yellow; fine or coarse), both of which are now carefully advancedthrough the intervertebral foramen (fig. 5-7).

Once again under medialization in the transversal level, ream in the direction of the herniateddisc.

The position of the reamer is always monitored at two levels with the C-arm. The dura of themedulla remains completely untouched if the medial interpedicular line (fig. 8) is not trans-gressed.

Caution: A very large foramen may cause the guiding rod and guiding tube to mediallyadvance. This should be avoided as it may lead to irritation or even damage nerve roots.

> Guiding Rod – yellow> Guiding Tube – yellow> Reamer Ejector – yellow

> Crown Reamer – yellow > Handle for Reamer > Guiding Rod – green, blunt

1

3

5

7

6

8

4

2

The following instruments and components are necessary for this step:

=̂ =̂

TESSYS® Instrument Set TESSYS® Disposable Access Kit

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Product Usage Guide STEP 8 Product Usage Guide STEP 8

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography2120

Third Reamer (light red fine or dark-red coarse)

STEP 8

Once you have completed the reaming process in step 7, remove the guiding rod II (yellow),the guiding tube II (yellow) and the crown reamer. Use the matching blunt guiding rod II forsafety reasons. The guide wire again remains in place! Now use the guide wire to posi-tion the conical guiding rod III (red) correctly over the guide wire (fig. 1). Use this guiding rodto position the guiding tube III (red). The third crown reamer III (red; find or coarse, 7.5 mm) isrotated over this in a counter-clockwise direction, and then clockwise upon contact with thebone, to extend the foramen (fig. 2 and 3). The position of the instruments and the reamingprogress are monitored under a.p. and lateral fluoroscopic control. The crown reamer shouldnever be turned over the medial interpedicular line in the a.p. position (fig. 4).

Now remove the crown reamer III (red). Insert one of the fenestrated working tubes (with anouter diameter of 7.5 mm) over the remaining guiding rod and guiding tube. For protection, theprotruding lip of the working tube is initially rotated in the direction of the nerve root (fig. 5).Then remove the guide wire, guiding rod III (red) and guiding tube III (red, fig. 6).

Monitor the position of the working tube under x-ray conditions. In the extended foramen, theworking tube is positioned at disc level, exactly at the medial interpedicular line (fig. 7) andaimed at the herniated disc fragment in the epidural space (fig. 8).

> Guiding Rod – red> Guiding Tube – red> Reamer Ejector – red> Working Sleeve

> Crown Reamer – red> Handle for Reamer > Guiding Rod – yellow and red, blunt

1

3

5

7

6

8

4

2

The following instruments and components are necessary for this step:

=̂ =̂

TESSYS® Instrument Set TESSYS® Disposable Access Kit

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Product Usage Guide STEP 9 Product Usage Guide STEP 9

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography2322

The Foraminoscope

STEP 9

After the HDI-lamp of the C-/D-Camsource® has been activated, white balancing is performedfor optimum color results. Now insert the joimax® Foraminoscope through the selected wor-king tube (fig. 1 and 2). Attention: Observe pressure and flow values (see instructionfor use for joimax® Multi-Range Irrigation Pump)! The various tissue structures willbecome visible. Herniated tissue, colored by chromography (discography), is clearly distinguis-hable from the nerve root and the dura (fig 3-5).

Should the surgery concern a central spinal canal stenosis, this can be successfullytreated using the unique TESSYS® Spinal Stenosis Program according to Dr. RudolfMorgenstern. Please find further steps for this method in the product usage guide forspinal canal stenosis.

joimax® ForaminoscopesAll Foraminoscopes are available in the versions C = single cable technology (combo) or O = ocular technology (ocular), have an OD of 6.3 mm, a viewing angle of 30° and 1 irrigation channel as well as 1 suction channel, ID 1.5 mm each.

Both versions are available in lengths of 174 mm and 208 mm.OD = Outer Diameter, ID = Inner Diameter

Ocular scope version

1

2

4 5

3

Combo version

TESSYS® Foraminoscopes

C-Camsource®

JIFP 2000 Multi-Range Irrigation Pump

Tubing Set

TESSYS® Spinal Stenosis Tray acc. to Dr. R. Morgenstern

Single cable technology: combined camera and light source system

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Product Usage Guide STEP 10 Product Usage Guide STEP 10

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography2524

Removal of Extruded Disc Material

STEP 10

For further orientation on the endoscopic image, insert nerve probes, hooks or elevators throughthe foraminoscope. During removal of the herniation the patient is responsive for the entire time.Now remove loose tissue and free disc fragments gradually with the various instruments suchas graspers, forceps and punches (fig. 1-4). Large free fragments should be removed by pulling the endoscope with the fragment out of the working tube (fig. 5). If orientation is clear,the shorter forceps can be used to remove large fragments without the endoscope but under C-arm control.

Once all free disc fragments have been removed, check endoscopically whether the affectednerve root has been freed (fig. 6). Now turn the opening of the working tube (window) so thatthe nerve root is protected and the opening points towards the disc space. Further free frag-ments can be removed from the interim disc space under x-ray control. Often both nerve rootsare visible at the end.

RF Trigger-Flex™ ProbeThe radiofrequency Trigger-FlexTM probe can be used to stop any bleeding and remove tissue(e.g. scars). Through tissue shrinkage, the annulus ruptures can be closed by up to 3 mm (fig. 7and 8). See instructions for use for joimax® Trigger-FlexTM.

The following instruments are necessary for this step:> Endoscopic Forceps> Other Bipolar Forceps and Graspers

1

3

5

2

7

6

8

4

Surgi-MaxTM Trigger-FlexTM RF-Probe

Surgi-MaxTM

TESSYS® Instrument Set

Page 14: Product Usage Guide - Lindare Medical Ltdlindaremedical.co.uk/wp-content/uploads/2017/07/joimax_OPB_EN_l… · Disc Herniation. In: SPINE Volume 33, Number 9, 2008 7. AWMF Online,

Product Usage Guide STEP 11 Product Usage Guide ANAESTHESIA RECOMMENDATION

> Fragmentectomy > Foraminoplasty > Decompression > Nucleotomy > Annuloplasty > Discography2726

Irrigation and Wound Closure

STEP 11

Finally, irrigate the disc space with saline-antibiotic solution and remove the remaining workingtube. Close the small skin incision with a 3.0 suture.

Additional instrumentsThe affected vertebral endplates can be skimmed with a straight or curved tip awl. A rise ofthe fluid content of the nucleus pulposus (high intensity in the MRI) can be seen in the firstclinical trials after 3 and 6 months.

TESSYS® Anaesthesia Recommendation

> Suture

The following TESSYS® Centers use the anaesthesia regime below:

> ATOS Klinik, Munich/Germany; Dr. Michael Schubert > HELIOS-Klinik, Volkach/Germany; Dr. Florian Maria Alfen> Marienstift, Arnstadt/Germany; Dr. Guntram Krzok> HELIOS-Klinik, Berlin-Buch/Germany; Prof. Dr. Jürgen Kiwit> Bethanien-Krankenhaus, Frankfurt/Germany; Dr. Ralf Wagner > Rugkliniek Iprenburg, Veenhuizen/Netherlands; Dr. Menno Iprenburg> Centro Médico Teknon, Barcelona/Spain; Dr. Rudolf Morgenstern> Sheeba-Hospital, Tel Aviv/Israel; Dr. Moshe Levinkopf> Rush Copley Aurora, Chicago, IL/USA; Dr. Daniel Laich> Mid Atlantic Spine, Maryland/USA; Frank J. E. Falco, M.D.> Seashore Surgical Institute, New Jersey/USA; Gabriel P. Jasper, M.D.> Middlesex Surgery Center, New Jersey/USA; Doug Spiel, M.D.

All doses mentioned below are recommended by Dr. Alexander Godschalx(anaesthesiologist, Rugkliniek-Iprenburg, Veenhuizen / Netherlands), and correspond to the respective patient:

Analgo Sedation:> Preoperative:

Analgetic: Piritramid (e.g.: 15 mg Dipidolor® i.m.)Sedation: Midazolam (e.g.: 1-2 mg Dormicum®)

> Intraoperative Analgo Sedation:Antibiotic: Cefalozin (e.g.: 2.0 g Gramaxin® i.v. )Sedation: Midazolam (e.g.: 3-5 mg Dormicum® i.v.)Central Sedation: Remifentanyl (e.g.: 0.05 μg / kg BW / min Ultiva® i.v.)

> Postoperative:Analgetic: Individual decision depends on the patient

> Discography / Chromography:Contrast Medium e.g.: Lohexol (e.g.: Omnipaque®) mixed with Indigo Carmine (5ml / 1ml)for improved tissue differentation, particularly important in the starting phase.

> Additional Drugs:Local anaesthesia: e.g.: Xylonest® 2 % plus Adrenaline – if required: Bacitracin 2500 I.E. (e.g.: Nebacetin®) and Neomycin Sulfate 35,000 I.E. (e.g.: Bivacin®)

The following components are necessary for this step:

Awls for a vertebral body endplate perforationin AP view

Trigger-FlexTM RF-Probe in the spinal canal

joimax® continuously develops new targeted indication products. In order to receive informationabout our latest developments, please contact your joimax® representative, send us an email orcall us. We look forward to hearing from you. Information about our Education Program can alsobe found at www.joimax.com.

TESSYS® Disposable Access Kit