29 plytki szyjne - chm.eu · 13 40.4832.100 Chwytak do płytek Holder for plates Держатель для пластин 1 14 40.4833 Miarka głębokości otworu Depth gauge Измеритель

IMPLANTS •INSTRUMENT SET •

SURGICAL TECHNIQUE •

instruction

CERVICAL LOCKING PLATE SYSTEM

0197ISo 9001ISo 13485

29C

3ChM Ltd., Lewickie 3b, 16-061 Juchnowiec K., POLAND

tel. +48 85 713-13-20 ÷ 25 fax +48 85 713-13-19 e-mail: [email protected]

TABLE OF CONTENT

I. IntroduCtIon .......................................................................................................................................................... 5

II. IMPLAntS .................................................................................................................................................................. 6

III. InStruMEntS .......................................................................................................................................................... 7

IV. SurGICAL APProACH ........................................................................................................................................... 9

V. SurGICAL tECHnIQuE .......................................................................................................................................... 10

Edition 29C of 04.05.2010, reviewed 21.11.2011

mailto://[email protected]



INTRODUCTION

Features and benefi ts of cervical locking plate system:

● low-profi le plates with open structure, pre-bent to fi t cervical lordosis,● hole plate design allows both rigid and angular setting the locking screws● locking mechanism of elastic rings integrated with the plate holes prevents screw migration in the case of their loosening,● set of self-tapping screws available in two diameters allows for one- or bi-cortical fi xation of the plate in the vertebral body,● set of plates gives possibility of one, two, three or four -level stabilization.

I. IntroduCtIon

Cervical locking plate system has been created to carry out one-, two-, three- or four-level cervical spine stabilization with anterior surgical approach.

Indications: ● degenerative disc disease,● fractures and instability,● deformities,● tumors.

The implants are made of titanium and its alloys in accordance with ISO 5832. The guarantees of high implants quality are the Quality Management System ISO 9001, ISO 13485 and complying with the requirements of the Directive 93/42/EEC.

System consists of:● implants: cervical locking plates, screws,● instrumentation set,● instruction for use.

6

TYTAN, Titanium, ТитанOtworyHoles

Отверстия

L [mm]

A [mm]

Nr katalogowy,Catalogue no.,

№ по кат.

4 23 14 3.3133.023 25 16 3.3133.02528 18 3.3133.028


Отверстия

L [mm]

A [mm]


№ по кат.

637 14 3.3133.037 39 15 3.3133.039 41 16 3.3133.041 43 17 3.3133.043 46 18 3.3133.046


Отверстия

L [mm]

A [mm]


№ по кат.

1069 15 3.3133.06973 16 3.3133.07377 17 3.3133.07781 18 3.3133.08185 19 3.3133.08589 20 3.3133.089

A L

AL

A

ALA

A

AL

AA

A

Sam

ogw

intu

jące

Sel

f - ta

ppin

gса

мон

арез

ающ

ий

L

Ø4,0

TYTAN, TitaniumТитан

L [mm]Nr katalogowy,Catalogue no.,

№ по кат.12 3.3201.012 14 3.3201.014 16 3.3201.016 18 3.3201.018

Sam

ogw

intu

jące

Sel

f - ta

ppin

gса

мон

арез

ающ

ий



№ по кат.12 3.3202.01214 3.3202.01416 3.3202.01618 3.3202.018

±10° ±10°

Sam

ogw

intu

jące

Sel

f - ta

ppin

gса

мон

арез

ающ

ий



№ по кат.12 3.3999.012 14 3.3999.014 16 3.3999.016 18 3.3999.018

Sam

ogw

intu

jące

Sel

f - ta

ppin

gса

мон

арез

ающ

ий



№ по кат.12 3.3998.012 14 3.3998.014 16 3.3998.016 18 3.3998.018

Wkręty wielokątne, Variable angle screws, Угловые переменные винты Wkręty sztywne, Fixed angle screws, Жесткие винты

0°

wkręty wielokątnevariable angle screwsугловые переменные винты

wkręty sztywnefi xed angle screwsжесткие винты


Отверстия

L [mm]

A [mm]


№ по кат.

850 14 3.3133.05053 15 3.3133.05356 16 3.3133.05659 17 3.3133.05962 18 3.3133.06265 19 3.3133.065

3.1291.xxx

3.3201.xxxlub • лубо • or



3.3999.xxx

L

Ø4,0

L

Ø4,5

L

Ø4,5

Sam

owie

rcąc

eS

elf-d

rillin

gса

мос

верл

ящий


L [mm]


№ по кат.12 3.3994.012 14 3.3994.014 16 3.3994.016 18 3.3994.018

L

Ø4,0

Sam

owie

rcąc

eS

elf-d

rillin

gса

мос

верл

ящий


L [mm]


№ по кат.12 3.3996.012 14 3.3996.014 16 3.3996.016 18 3.3996.018

L

Ø4,5

Sam

owie

rcąc

eS

elf-d

rillin

gса

мос

верл

ящий


L [mm]


№ по кат.12 3.3997.012 14 3.3997.014 16 3.3997.016 18 3.3997.018

L

Ø4,5

Sam

owie

rcąc

eS

elf-d

rillin

gса

мос

верл

ящий


L [mm]


№ по кат.12 3.3995.012 14 3.3995.014 16 3.3995.016 18 3.3995.018

L

Ø4,0

2

4°0°

wkręty sztywnefi xed angle screwsжесткие винты

wkręty wielokątnevariable angle screwsугловые переменные винты

16°

[40.4865.000]

ChM Ltd., Lewickie 3b, 16-061 Juchnowiec K., POLANDtel. +48 85 713-13-20 ÷ 25 fax +48 85 713-13-19 e-mail: [email protected]

IMPLANTS

II. IMPLAntS

7

1. Trokar CTrocar CТрокар C[40.4821.000]

6-9. Wiertło z ogranicznikiem C Ø2,2Drill with limiter C Ø2,2Cверло c ограничителем C Ø2,2

3. Wkręt pozycjonujący tymczasowy CTemporary fi xation screw CВременный позиционный винт С[40.4826.125]

4. Wkrętak krzyżakowy CCross screwdriver СОтвертка под крест С[40.4828.000]

5. Wyginak do płytekBender for platesИзгибатель пластин[40.4830.000]

[40.4831.012]

[40.4831.014]

[40.4831.016]

[40.4831.018]

2. Prowadnica do wiertła C - sztywnaC Drill guide - fi xed angleНаправитель сверла C - жесткий[40.4836.000]

Lp.Nr katalogowyCatalogue no.

№ по кат.Nazwa Name Название

Szt.PcsШт.

1 40.4821 Trokar C Trocar C Троакар C 12 40.4825 Prowadnica do wiertła C - wielokątna Drill guide C - variable angle Направитель сверла C - угловой переменный 13 40.4826.125 Wkręt pozycjonujący tymczasowy C Temporary fi xation screw C Временный позиционный винт С 24 40.4828 Wkrętak krzyżakowy C Cross screwdriver C Отвертка под крест С 15 40.4830 Wyginak do płytek Bender for plates Изгибатель пластин 16 40.4831.012 Wiertło z ogranicznikiem C Ø2,2/12 Drill with limiter C Ø2,2/12 Cверло c ограничителем C Ø2,2/12 17 40.4831.014 Wiertło z ogranicznikiem C Ø2,2/14 Drill with limiter C Ø2,2/14 Cверло c ограничителем C Ø2,2/14 18 40.4831.016 Wiertło z ogranicznikiem C Ø2,2/16 Drill with limiter C Ø2,2/16 Cверло c ограничителем C Ø2,2/16 19 40.4831.018 Wiertło z ogranicznikiem C Ø2,2/18 Drill with limiter C Ø2,2/18 Cверло c ограничителем C Ø2,2/18 1

10 40.2049.180 Wiertło Ø2,5/180 Drill Ø2.5/180 Сверло Ø2,5/180 111 40.0330 Wkrętak sześciokątny z chwytakiem S 2,5 Hexagonal screwdriver with holder S 2.5 Отвертка шестигранная с держателем S 2,5 112 40.5286.000 Wkrętak do wkrętów szyjnych lity Screwdriver for cervical screws solid Oтвертка шейная для винтов сплошная 113 40.4832.100 Chwytak do płytek Holder for plates Держатель для пластин 114 40.4833 Miarka głębokości otworu Depth gauge Измеритель глубины 115 40.4834 Miarka rozmiaru płytki Proportions Шаблон размера пластин 116 40.4836 Prowadnica do wiertła C -sztywna Drill guide C - fi xed angle Направитель сверла C - жесткий17 40.4838.500 Statyw Stand Ящик-штатив 1

40.4820.500


INSTRUMENTS

III. InStruMEntS

8

14. Miarka głębokości otworuDepth gaugeИзмеритель глубины[40.4833.000]

13. Chwytak do płytekHolder for platesДержатель для пластин[40.4832.100]

15. Miarka rozmiaru płytkiProportionsШаблон размера[40.4834.000]

17. StatywStandЯщик-штатив[40.4838.500]

12. Wkrętak do wkrętów szyjnych lityScrewdriver for cervical screws solidOтвертка шейная для винтов сплошная[40.5286.000]

16. Prowadnica do wiertła C - wielokątnaC Drill guide - variable angleНаправитель сверла C - угловой переменный[40.4825.000]

11. Wkrętak sześciokątny z chwytakiem S 2,5Hexagonal screwdriver with holder S 2.5Отвертка шестигранная с держателем S 2,5[40.0330]

16. Prowadnica do wiertła C - wielokątnaC Drill guide - variable angleНаправитель сверла C - угловой переменный[40.4825.000]


INSTRUMENTS



SURGICAL APPROACH

IV. SurGICAL APProACH

Anterior approach to the cervical spineFor plate osteosynthesis of cervical spine, the anterior approach allowing visibility of the vertebral bodies from C3 to Th1 is used. Left-sided surgical approach is recommended due to the reduced risk of accidental damage to the recurrent laryngeal nerve.

Patient positioningPatient is placed in supine position, with a small pillow between the shoulder to secure the neck in an extended position. Patient’s head is turned in the opposite direction to the planned skin incision. If necessary, skeletal traction or loop may be used. This can be useful at a later stage of the operation, when there is a need for some distraction of cervical spine. It is advisable to tilt the operating table at about 15-30 degrees (Trendelenburg position) to prevent bleeding and to ensure access to the neck.

Exposure may be through either a transverse or longitudinal incision, depending on the surgeon`s preference. Transverse incision is recommended because of cosmetic results (the postoperative scar is covert with the natural folds of skin). This incision is slightly obliquely extend from the midline to the posterior edge of sternocleidomastoid muscle. Infi ltration of the skin and subcutaneous tis-sue with epinephrine solution aids hemostasis.

After reaching the front surface of the vertebrae the automatic refractor may be applied to retract muscles. Care must be taken to not damage the oesophagus or the vascular-nerve bundle of neck. Access widening may be performed with confi dence and ap propriate protection of recurrent laryngeal nerve, trachea and esophagus.

The desired level is identifi ed and confi rmed with the lateral radiograph (place the needle into disc space!) or image intensifi er. Removal of disc and osteophytes and decompression of spinal canal is then performed.

Caution: removal of the osteophytes is essential for proper placement of locking plates.

10

1

2


SURGICAL TECHNIQUE

The above description is not detailed instruction of conduct. The surgeon decides about choosing the operating procedure.

Make sure that factory-made curvature of selected plate fi ts ana-tomical curvature of the spine. If needed, the plate curvature may be modifi ed using the Bender For Plates [40.4830.000].

• The plate shall be bent between the holes designed for screw insertion. • Multiple bending can cause mechanical weakening or/and the implant damage!

Placing the plate. Temporary locking using the posi-tioning screws (anchor screws).

Use the Holder for Plates [40.4832.100] to place the plate in de-sired position: rest it`s posterior surface on vertebral bodies.

Placing the plate. Temporary locking using the posi-2

Reduction of lordosis bentIncreasement of lordosis bent

V. SurGICAL tECHnIQuE

Plate selection.

Before spinal decompression and plate implantation use the Proportion tool [40.4834.000] to defi ne the proper size of the intervertebral graft and locking plate. Insert temporarily selected plate. Use the same Proportion tool to confi rm adequate size of the plate

Plate selection.1

11

40.4825.00040.4836.000

±10°


SURGICAL TECHNIQUE


The Drill Guide [40.4825.000] is intended for preparing holes for the variable angle screws. Drill Guide [40.4836.000] is intended for the fi xed angle screws.

Cortical penetrations.

Cortical penetration may be done us ing the Trocar [40.4821.000], which is in-serted through the sleeve of the Drill Guide [40.4825.000] or [40.4836.000]. Rounded tip of the Drill Guide sleeve is insert ed into the hole setting the trajectory of the bone channel. The Drill Guide [40.4836.000] shall be set in the axis of the plate hole. The Drill Guide [40.4825.000] is to be an-gularly defl ected to the desired position. Cortical pen etration is done pushing the Trocar into the depth of about 5 mm.

Cortical penetrations.3

To maintain the desired position of the plate at tach it to the vertebral bodies using one or two Positioning Screws [40.4826.125]. Insert Positioning Screws using the Hexagonal Screwdriver With Holder S 2.5x5.0 [40.0330.000] under the image intensifi er control.

Note! The trajectory of the Positioning Screw forces a subsequent trajectory of the locking screw.



SURGICAL TECHNIQUE


Drilling the hole.

If making of the channel for screw is needed use the Drill With Limiter [40.4831.0xx]. Basing on X-Ray images, the appropriate drill length shall be set (the drill sizes correspond to the lengths of locking screws). Then, in a selected hole provided for the lock-ing screw insertion, the rounded tip of the Drill Guide sleeve [40.4825.000] or [40.4836.000] shall be placed. Drilling process shall be done under X-Ray control until stopping of the limiter of the drill on the Drill Guide.

The process shall be controlled with Image Intensifi er.

The Trocar [40.4821.000] and the Drills [40.4831.0xx] shall be used only with the Drill Guide [40.4825.000] or [40.4836.000].

Drilling the hole.4

Selection and insertion of the screw.

If needed, the length of the bone channel shall be verifi ed us-ing the Depth Gauge [40.4833.000]. The tip of the Depth Gauge shall be in serted until the perceptible resistance. Read the length of locking elements (screws) on the Depth Gauge. The value on the Depth Gauge corresponds to the length of the locking screw.

Selection and insertion of the screw.5



SURGICAL TECHNIQUE


After removal of Positioning Screws [40.4826.125] insert the other screws performing above described steps.

The tip of the Solid Screwdriver For Cervical Screw [40.5286.000] is connected with the head of locking screw and secured by the sliding peripherally the sleeve. Insert the screw into the plate hole and tighten it until ‘click’ sound is heard.

14

7

6


SURGICAL TECHNIQUE


Fixing the bone graft.

If fi xing of the bone graft (placed in the intervertebral space) is necessary the additional use of screws is possible [3.1291.xxx]. They are inserted through the oval holes of the plate using the Screwdriver S2.5 [40.0330.000].

Fixing the bone graft. Fixing the bone graft.7

Screw removal.

If plate removal is needed, insert the tip of Screwdriver For Locking Cervical Screws [40.4828.000] and secure it by turn ing the nub A. Then slide the sleeve of screwdriver peripherally rotat-ing it clockwise until the taper of the sleeve advancing into the plate hole expands elastic locking ring. Continue sliding until the head of sleeve securely rests on the screw. Unscrewing of the locking screw is then possible.

Screw removal.6

pokrętło A

tuleja

REUSABLE ORTHOPAEDIC AND SURGICAL INSTRUMENTS

Instruments manufactured by ChM Ltd. are made of stainless steel, aluminium alloys and plastics according to ISO standards. Each medical instrument is exposed to occurrence of corrosion, stains and damage, if not treated with special care and recommendations below.

1. MaterialsDevices are produced of corrosion-resistant steels. The protective layer (passive layer) against corrosion is formed on the surface of the stain-less steel due to high content of chromium.Devices produced of aluminium are mainly stands, palettes, cuvettes and some parts of instruments such as handles of screwdriver, awl or wrench, etc. The protective oxide layer, which may be dyed or stay in natural colour (silvery-grey), is formed on the aluminium as an effect of electrochemical surface treatment on its surface. Devices made of aluminium with processed layer have a good corrosion resistance. The contact with strong alkaline cleaning and disinfecting agents, solutions containing iodine or some metal salts due to chemical interference on the processed aluminium surface shall be avoided.Devices are mainly manufactured out of following plastics: POM-C (Polyoxymethylene Copolymer), PEEK (Polyetheretherketone) and teflon (PTFE). The above mentioned materials can be processed (washed, cleaned, sterilized) at temperatures not higher than 140°C, they are stable in aqueous solution of washing-disinfection with pH values from 4 to 9.5.

If the material of the device cannot be specified, please contact ChM Ltd. company representative.

2. Disinfection and cleaningEffective cleaning is a complicated procedure depending on the following factors: the quality of water, the type and the quality of used deter-gent, the technique of cleaning (manual/machine), the correct rinsing and drying, the proper preparation of the instrument, the time, the tem-perature. Internal procedures of sterilizers, recommendations of cleaning and disinfection agents, as well as recommendations for cleaning and sterilizing automatic machines shall be observed.

Read and follow the instructions and restrictions specified by the manufactures of the agents used for disinfection and cleaning procedures.

1. Before the first use, the product has to be thoroughly washed in the warm water with washing-disinfecting detergent. It is important to follow the instructions and restrictions specified by the producer of those detergent. It is recommended to use water solutions of cleaning-disinfec-tion agents with a neutral pH.

2. After use, for at least 10 minutes the product has to be immediately soaked in an aqueous disinfectant solution of enzyme detergent with a netural pH (with a disinfection properties) normally used for reusable medical devices (remember to prevent drying out any organic re-mains on the product surface). Follow all the instructions specified by the producer of those enzyme detergents.

3. Carefully scrub/clean the surfaces and crevices of the product using a soft cloth without leaving threads, or brushes made of plastic, only the nylon brushes are recommended. Do not use brushes made of metal, bristles or damaging material as they can cause physical or chemical corrosion.

4. Next, thoroughly rinse the instrument under the warm running water, paying particular attention for carefully rinsing the slots. Use nylon brushes making multiple moves back and forth on the surface of the product. It is recommended to rinse in demineralized water, in order to avoid water stains and corrosion caused by chlorides, found in the ordinary water, and to avoid forming the stains on the surface such as anodized. During the rinsing manually remove the adherent remains.

5. Visually inspect the entire surface of the product to ensure that all contaminations are removed.

If there are any residues of human tissue or any other contamination, repeat all stages of the cleaning process.

6. Then, the instrument has to undergo a process of machine washing in the washer-disinfector (use washing-disinfecting agents recom-mended for reusable medical devices and instruments).

Procedure of washing with the washer-disinfector shall be performed according to internal hospital procedures, recommendations of the washing machine manufacturer, and instructions for use prepared by the washing-disinfection agents manufacturer.

3. SterilizationBefore each sterilization procedure and application, the device has to be controlled. The device is to be efficient, without toxic compounds as residues after disinfection and sterilization processes, without structure damages (cracks, fractures, bending, peeling). Remember that sterilization is not substitute for cleaning process!

Devices manufactured out of plastics (PEEK, PTFE, POM-C) may be sterilized by any other available sterilization method validated in the centre but the sterilization temperature is not to be higher than 140°C.

Sterilization of surgical instruments shall be carried out using equipment and under the conditions that conform to applicable standards. It is recommended to sterilize in steam sterilizers where sterilizing agent is water vapour. Recommended parameters of the sterilization method: temperature min. 134°C, pressure of 2 atm.

The above given parameters of sterilization are to be absolutely observed.

Validated sterilization methods are allowed. Durability and strength of instruments highly depend on their usage. Careful usage consistent with in-tended application of the product, prevents product damaging and prolongs its life.

SALES OFFICEtel.: + 48 85 713-13-30 ÷ 38fax: + 48 85 713-13-39

ChM Ltd.Lewickie 3b16-061 Juchnowiec K.Polandtel. +48 85 713-13-20fax +48 85 713-13-19e-mail: [email protected]

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Documents

29 plytki szyjne - chm.eu · 13 40.4832.100 Chwytak do płytek Holder for plates Держатель для пластин 1 14 40.4833 Miarka głębokości otworu Depth gauge Измеритель