Cessys Product User Guide PDF

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Product Usage Guide


Step by Step Instructions for
Anterolateral Access to the Cervical Spine
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Product Usage Guide CONTENTS

3 INTRODUCTION

4 CONCEPT

5 INSTRUMENTS

6 INDICATIONS

7 DIAGNOSIS CONFIRMATION / PREOPERATIVE PLANNING / ANESTHESIA

8 PATIENT POSITIONING / ACCESS DETERMINATION

9 ACCESS PLANNING

10 ACCESS

13 DECOMPRESSION

15 NOTES

16 STUDIES AND LITERATURE

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Product Usage Guide INTRODUCTION

Cervical Disc Herniation


Cervical disc disease is a common cause of disability in those over fifty and may present as
radiating pain, numbness and/or weakness of the shoulders, arms and hands. It occurs most
commonly in the lower segments of the cervical spine (C5/6, C6/7 and C7/T1) and may cause
irreparable nerve damage and impairment. In such cases, surgery is unavoidable. Standard
procedures for minimal disc removal often require a large exposure and therefore, more tissue
injury with a higher risk of infection. In many cases the entire disc is removed and a cervical
fusion is required. This means additional forces are then transferred to the spinal segments
above and below the fused, immobile segment, often resulting in adjacent level disc disease.
For this reason, minimally invasive surgical procedures are a more desirable and promising al-
ternative. Through continuous development of innovative technologies in the field of endoscopy,
a less traumatic and direct approach to the pathology can ensure a faster recovery. Today, HD
quality endoscopes with an outer diameter of less than 4 mm and an integrated irrigation and
working channel are possible. This technology is now available to ensure efficiency and safety
during procedures of the cervical spine. Through the anterolateral approach with CESSYS
instrumentation, the disc can be spared via a transdiscal herniation removal. Preserving the
disc is especially important in the younger patient population to help provide a better quality
of life for the future.

Sagittal MRI Axial MRI

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Product Usage Guide CONCEPT

The CESSYS Concept


The CESSYS technique utilizes a direct, ventral approach to the intervertebral disc of the
cervical spine. Under endoscopic control the compressive disc material can then be targeted
and removed.

Advantages

The procedure is minimally invasive and gentle


The disc is preserved along with the natural structure of the spinal segment
No implant, so no associated implant failure risk
The ventral approach avoids any spinal cord manipulation
Shorter recovery
Very small incision for cosmetically good results

This procedure can be performed with the patient under general anesthesia or monitored
anesthesia care (MAC). MAC greatly reduces the risks associated with general anesthesia
and has the added benefit of immediate patient feedback if contact is made with the neural
structures. This procedure is performed with the patient in the supine position.

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Product Usage Guide INSTRUMENTS

CESSYS Instrument Set with Cervical Hybrid Endoscope

Cervical Hybrid Endoscope Characteristics


outer diameter 3.9 mm / 2.6 mm
working channel 2.1 mm
shaft length 100 mm
rinsing channel 1.2 mm
optics 1.2 mm mit 40,000 Pixel
optic angel 6
angel of view 95 5

Working tubes
outer diameter 5 mm
working length 100 mm

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Product Usage Guide INDICATIONS

Surgical Indications for Cervical Disc Herniation


Cervical nerve root compression with or without significant neurological deficit and failure
of conservative treatment measures.

Radiographic Indications
Soft disc herniations which are clearly visible on computed tomography
(CT) or magnetic resonance imaging (MRI).

Contraindications
Dried or sequestered disc herniations
Significant ossification of the posterior
longitudinal ligament (PLL)
Cervical stenosis
Cervical spondylosis
Segmental instability
Other pathological conditions such as:
fractures, tumors or active infections
Bone spurs or osteophytes greater than 2 mm
Any hindrance of radiographic visualization during
the procedure (i.e. obstructed lateral imaging of
C6/7 and C7-T1)

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Product Usage Guide DIAGNOSIS CONFIRMATION / PREOPERATIVE PLANNING / ANESTHESIA

Diagnosis Confirmation
Confirm the diagnosis and treatment of cervical disc disease as indicated for endoscopic spine
surgery in accordance with the guidelines of your country.

Preoperative Planning
Determine the precise herniation location via sagittal and axial MRI imaging prior to
access with the CESSYS instrumentation. The images should be consistent with the clinical
diagnosis and current symptoms and no more than three months old. In addition, preoperative
films (lateral and A/P) should be available.

To confirm the diagnosis, a myelography can be performed.

Sagittal MRI Axial MRI


Source: IMAIOS e-Anatomy

Source: IMAIOS e-Anatomy

Lateral X-ray A/P X-ray

Anesthesia
The CESSYS procedure can be performed under MAC or general dependent upon patient
toleration. Recommendations can be found in the joimax brochure, "Anesthesia Options".

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Product Usage Guide PATIENT POSITIONING / ACCESS DETERMINATION

Positioning of the Patient


The positioning is consistent with other surge-
ries requiring ventral access to the cervical
spine. The patient is placed in a supine position
with the neck slightly extended and fixed. If the
patient is sedated, extra caution must be taken
to ensure any movement during the procedure
is prevented. The use of a Mayfield head hol-
der is recommended. Verify proper positioning
The patient is placed in supine position. via A/P and lateral X-ray. For access in the
lower cervical spine, the arms and shoulders
should be pulled caudally and fixed. Initial access is achieved under fluoroscopic monitoring
under the lateral view. In the lower cervical spine, the C-arm may need to be positioned
obliquely for optimal visualization.
ipsilateral access

Determination of the access


co

Access to the herniation can be made ipsilate-


ntr
al
ate

ral or contralateral dependant upon the loca-


ral
ac
ce

tion. For foraminal herniations, access is


ss

generally contralateral. An ipsilateral access


can be utilized when direct access to the
herniation is hindered, for example, by the
uncinate process.

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Product Usage Guide ACCESS PLANNING

Access Planning
Determine the precise herniation location via sagittal and axial MRI imaging prior to access
with the CESSYS instrumentation.

Anatomical landmarks are identified and marked for optimal access planning. It is helpful to
identify and mark the chin at midline, sternal notch, larynx, directional line of the sternocleido-
mastiod muscle and both clavicles. Under fluoroscopic view, mark the intervertebral disc line
at the level to be treated.

1
4

2 5
3

Marking lines on the patient; Sagittal MRI of the herniated C3/4 intervertebral
1. Clavicle 2. Sternum 3. Larynx disc
4. Sternocleidomastoid Muscle 5. Midline

Note
Provides case manner and to uniquely identify the nucleus tissue a Chromographie with indigo
After insertion of the 18G needle, discography with Indigo Carmine, provides clear identification
of nuclear tissue (see page 11).

To identify the exact position of the herniation,


discography may be performed. Insert the 18G
needle into the center of the disc, remove the
stylet and inject the disc with a 1:4 ration of
Indigo Carmine to contrast agent.

Discography

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Product Usage Guide ACCESS

Access
The ventral neck is palpated via the middle and index
fingers (see right). The esophagus and the trachea are
manually displaced medially and the neurovascular
bundle laterally.

After determination of the entry point via lateral X-ray,


the neck is palpated and along the two fingers, the
18G spinal needle is inserted anterolateral to the disc at
disc level.

Inserting the spinal needle under lateral X-ray.

To avoid risk of injury to the vertebral arteries and spinal nerves, is important to ensure the
access to the intervertebral disc space is not positioned too far laterally. In the correct position,
the needle tip should be positioned at the dorsal edge of the annulus and directed toward the
pathology. The stylet of the needle is removed and the guide wire is then inserted through the
needle. The needle is removed and the guide wire position is maintained.

Lateral X-ray Needle is placed at the dorsal edge of the annulus

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Product Usage Guide ACCESS

An incision of approximately 0.5 cm is made prior to sequential dilation. The guiding rod and
the guiding tube are then inserted over the guide wire.

Inserting the guide wire Dilatation

The instrument tip is located directly before the herniation, but still within the intervertebral
disc. Over the guiding tube the appropriate working tube is pushed (5.0 mm OD). Depending on
the location of the pathology can be made between three different tip configurations. In the
lateral X-ray the tip of the working tube is pushed gently to the posterior vertebral body edge.
The internal instrument are now removed.

Insertion of the working tube

There are three variations of the working tube which are selected according to the location of
the disc herniation and the structures to be protected.

Fenes
trated
Work
ing Tube,
45

Conical Double Fenestrated


Working Tube Working Tube

Rinsing Outflow

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Product Usage Guide ACCESS

Correct position of the working tube (45)

In many cases, bone removal may be necessary in order to reach the pathology. Various
instruments are available to achieve this. The longitudinal ligament and annulus may also
need to be opened dependent upon the diagnosis and location of the herniation.

Dilatator Reamer (OD 3.9 mm)


This is used through the working tube. The reaming process must be controlled by lateral
X-ray.

Hook Punch (2.7 mm OD)


This is used through the working tube to open the annulus
and must be controlled under lateral fluoroscopic imaging.

Endoscopic Crown Reamer (2.0 mm OD)


Bone reaming can be performed through the working channel of the
endoscope under direct visualization. The final position of the working tube
will be dependent upon the location of the pathology.

For central herniations, the tip of the working tube should be directed toward midline
under A/P fluoroscopic control.
For transforaminal herniations, the tip of the working tube should be directed toward the
affected foramen in the A/P fluoroscopic view.
The distal tip of the working tube should never extend beyond the edge of the
vertebral body edge, posteriorly.

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Product Usage Guide DECOMPRESSION

Intraoperative Diagnosis
During the surgery, the correct position of the instruments must be checked by radiation moni-
toring (X-rays lateral and ap) and to document if necessary.

Removal of the Compressive Material (herniation)


The endoscope is inserted through the working tube. It has an outer diameter of 3.9 mm, a 2.1
mm working channel and a 1.2 mm rinsing channel.

Herniation removal through the endoscope.

The compressive tissue and fragments can be removed through the annulus
with various forceps. It is important to ensure the spinal cord and nerve
roots are not injured during decompression.

Hemostasis, Tissue Ablation and Tissue Shrinkage


Bleeding can be stopped quickly and reliably with the bipolar RF Legato or Vaporflex
probe, through tissue shrinkage and coagulation under endoscopic visualization.

Additionally, the pressure of the fluid can be


increased temporarily via the irrigation pump
and/or by applying the end cap of the endos-
cope. To prevent damage to the neural ele-
ments, do not increase the pressure of the
pump above the diastolic blood pressure of the
patient (average diastolic BP is 60-80 mmHg).

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Product Usage Guide DECOMPRESSION

Sufficient decompression may be confirmed through visualization of the freed nerve root or
pulsation of the dura.

Patients under MAC anesthesia may verbally indicate absence of pain and symptomatic relief
during the procedure.

Wound Closure
At the end of the procedure, con-
firm in the disc space the ab-
sence of retained fragments.

Remove all instruments and


begin wound closure. Prior to
closure, the surgical access site
may be flushed with an antibio-
tic saline solution and/or injec-
ted with local anesthetic.

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Product Usage Guide NOTES

Notes

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Studies and Literature

1. Kim Daniel H., Choi Gun, Lee Sang-Ho, Endoscopic Spine Procedures;
Thieme New York Stuttgart, ISBN 978-1-60406-307-3
2. Choi G, Lee SH. The Textbook of Spine. Korean Spinal Neurosurgery Society, 2008:1173-1185
3. Lee SH, Lee JH, WC, Jung B, Mehta R, Anterior minimally invasive approaches for the
cervical spine. Orthop clin North Am 2007; 38; 327-337
4. Ruetten S, Komp M, Merk H, Godolias G. Full-endoscopic cervical Posterior
foraminotomy for the operation of lateral disc herinations using 5,9 mm endoscopes.
A prosepective randomized controlled study, Spine (Phila Pa 1976) 2008; 33; 940-948
5. Leitlinien fr Diagnostik und Therapie in der Neurologie; 4. berarbeitete Auflage 2008,
S. 654 ff, ISBN 9783131324146; Georg Thieme Verlag Stuttgart
6. Schubert, M; Perkutane zervikale Nukleotomie Ergebnisse einer prospektiven Studie mit
einem zwei Jahres-follow-up, Poster, Norddeutsche Orthopdenvereinigung, Juni 2009
7. Ahn Y, Lee SH, Shin SW. Percutaneous endoscopic cervical discectomy: clinical outcome
and radiographic changes. Photomedicine and Laser Therapy. 2005;23(4):362-8.
8. Chiu JC, Clifford TJ, Greenspan M, Richley RC, Lohman G, Sison RB. Percutaneous
microdecompressive endoscopic cervical discectomy with laser thermodiscoplasty.

joimax Product Usage Guide 04_2013 PUGCEEN Printed on chlorine-free paper Vegetable-based colors were used for printing
Mount Sinai Journal of Medicine. 2000;67(4):278-82.
9. Fontanella A. Endoscopic microsurgery in herniated cervical discs.
Neurol. Res. 1999 Jan;21(1):31-8.
10. Liu K-X, Massoud B. Endoscopic anterior cervical discectomy under epidurogram
guidance. Surg Technol Int. 2010 Okt;20:373-8.
11. Ruetten S, Komp M, Merk H, Godolias G. Full-endoscopic anterior decompression versus
conventional anterior decompression and fusion in cervical disc herniations. International
Orthopaedics. 2008 Nov 18;33:1677-82.
12. Shibayama M, Ito F, Miura Y, Nakamura S, Ikeda S. Percutaneous
endoscopic cervical discectomy. J Spinal Surgery. 2012;3(4):796-9.
13. Tzaan W-C. Anterior percutaneous endoscopic cervical discectomy
for cervical intervertebral disc herniation: outcome, complications and
technique. J Spinal Disord Tech. 2011 Okt;24(7):421-31.

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joimax, TES, TESSYS, iLESSYS, CESSYS, PeNuts, Vitegra, EndoLIF, Vitegra, Camsource,
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CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

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