instruction - rimanererimanere.com.mx/pdf/tecnicas/9_stabilizacja_kregoslupa_en.pdfchm ltd.,...

IMPLANTS •INSTRUMENT SET 40.5520 •

SURGICAL TECHNIQUE •

instruction

SPINE STABILIZATION

0197ISO 9001ISO 13485

9D

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

tel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

TABLE OF CONTENT

Issue 9D of 04.05.2010; last revised 02.08.2010

I. INTRODUCTION .......................................................................................................................................................... 5

II. IMPLANTS ................................................................................................................................................................. 6

III. INSTRUMENT SET FOR SPINE STABILIZER [40.4450.200] .................................................................................. 9

IV. SURGICAL TECHNIQUE ......................................................................................................................................... 12

IV.1. Posterior lumbar and thoracolumbar approach ........................................................................................... 12

IV.2. Screw selection. Locating the pedicle entry point ....................................................................................... 13

IV.3. Insertion of the screw - steps ...................................................................................................................... 15IV.3.1. Crosswise connectors ...................................................................................................................... 24IV.3.2. Polyaxial screws ............................................................................................................................... 25IV.3.3. Spreading screws ............................................................................................................................. 26

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5ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLAND


INTRODUCTION

I. INTRODUCTION

Spine Stabilization System BIALSTAB makes possible treatment of following parts of the spine: thoracic, thoraco-lumbar and lumbar within posterior approach. Sizes and types of implants allow patients treatment in different age.The assortment of implants is made of titanium and its alloys, in accordance with ISO 58�2 standard. High quality of implants is assured by Quality Management System ISO 9001: 2000, EN ISO 1�485: 200� and meets requirements of Directive 9�/42/EEC.

The system was developed in cooperation with prof. J. Skowronski from Orthopedic and Traumatology Clinic of Medical University of Bialystok.

The BIALSTAB system is composed of:

● implants (screws, hooks, locking parts)● instruments and devices used for implantation● instruction, surgical techniques, training films.

Spine stabilization with BIALSTAB allows for reconstruction of physiological spinal curvatureby appropriate reposition of vertabrae.The basic components of spine stabilizer are the transpendicular screws, combined together with connectors and frequently mate with hooks.The above mentioned implants make possible stabilization and fixation of moveable part of spine.

Indication:● fractures and instability● deformations (spondylolisthesis, scoliosis, hiperkyphosis, etc.)● degenerative changes● tumours.

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IMPLANTS

II. IMPLANTS

Spine stabilizer BIALSTAB consists of following implants:● Transpedicular screws (simple and spreading with mandrel),● Locking devices for transpedicular screws,● Transpedicular polyaxial screws (simple and spreading with mandrel),● Connecting devices (rods, crosswise connectors, clamps for crosswise connectors, universal hooks).

samogwintującyself - tappingсамонарезающий

ØL

Nr katalogowy, Catalogue no., № по кат.L

[mm] Ø4 Ø5 Ø6 Ø7 Ø8 Ø925 �.�204.025 �.�205.025 �.�206.025 �.�207.025 �.�208.025 �.�209.025�0 �.�204.0�0 �.�205.0�0 �.�206.0�0 �.�207.0�0 �.�208.0�0 �.�209.0�0�5 �.�204.0�5 �.�205.0�5 �.�206.0�5 �.�207.0�5 �.�208.0�5 �.�209.0�540 �.�204.040 �.�205.040 �.�206.040 �.�207.040 �.�208.040 �.�209.04045 �.�204.045 �.�205.045 �.�206.045 �.�207.045 �.�208.045 �.�209.04550 �.�204.050 �.�205.050 �.�206.050 �.�207.050 �.�208.050 �.�209.05055 �.�204.055 �.�205.055 �.�206.055 �.�207.055 �.�208.055 �.�209.05560 - �.�205.060 �.�206.060 �.�207.060 �.�208.060 �.�209.06065 - �.�205.065 �.�206.065 �.�207.065 �.�208.065 �.�209.065

Śruba przeznasadowa transpedikularna z wysoką główką (komplet)Transpedicular screw with high head(set)Транспедикулярный винт с высокой головкой (комплект)

ØL


[mm] Ø4 Ø5 Ø6 Ø7 Ø8 Ø9�0 �.�914.0�0 �.�915.0�0 �.�916.0�0 �.�917.0�0 �.�918.0�0 �.�919.0�0�5 �.�914.0�5 �.�915.0�5 �.�916.0�5 �.�917.0�5 �.�918.0�5 �.�919.0�540 �.�914.040 �.�915.040 �.�916.040 �.�917.040 �.�918.040 �.�919.04045 �.�914.045 �.�915.045 �.�916.045 �.�917.045 �.�918.045 �.�919.04550 �.�914.050 �.�915.050 �.�916.050 �.�917.050 �.�918.050 �.�919.05055 �.�914.055 �.�915.055 �.�916.055 �.�917.055 �.�918.055 �.�919.05560 - �.�915.060 �.�916.060 �.�917.060 �.�918.060 �.�919.06065 - �.�915.065 �.�916.065 �.�917.065 �.�918.065 �.�919.065


Śruba przeznasadowa rozporowa (komplet) Transpedicular spreading screw (set)Транспедикулярный распорный винт (комплект)

Ø

L

Nr katalogowy, Catalogue no., № по кат.

L [mm] Ø7 Ø8

�0 �.�215.0�0 �.�216.0�0�5 �.�215.0�5 �.�216.0�540 �.�215.040 �.�216.04045 �.�215.045 �.�216.04550 �.�215.050 �.�216.05055 �.�215.055 �.�216.05560 �.�215.060 �.�216.06065 �.�215.065 �.�216.065

Wkręt dociskowy z wkładką dociskowąCompressing screw with compressing insert

Зажимной винт с зажимной вкладкой

3.3283.205

Wkręt dociskowy z pierścieniemCompressing screw with ringЗажимной винт с обручой

3.3283.105

Nakrętka okrągłaRound cap

Круглая гайка

3.3281.005

Kolory Colors Ø 4 Ø 5 Ø 6 Ø 7 Ø 8 Ø 9

Kolory Colors Ø 4 Ø 5 Ø 6 Ø 7 Ø 8 Ø 9

Kolory Colors

Ø 7 Ø 8

Podstawowy dwu-elementowy zestaw blokującyBasic two-part locking set

Основной блокирующий комплект

Opcjonalny jedno-elementowy bloker zespolonyOptional one-part combined blockerВторой, цельный тип блокирования

Podstawowy dwu-elementowy zestaw blokujący

Basic two-part locking setОсновной блокирующий комплект

Opcjonalny jedno-elementowybloker zespolonyOptional one-part combined blockerВторой, цельный тип блокирования

*

Zamówienie na śruby z blokerem opcjonalnym należy składać uzupełniając ostatni trzy-cyfrowy człon nr katalogowego śruby oraz dodając nr katalogowy blokera.PRZYKŁAD: 3.XXXX.1XX + �.�28�.105.The order for screws with optional blocker should be placed by refi lling the last three-digit module of the screw’s catalogue number and adding catalogue number of the blocker.EXAMPLE: 3.XXXX.1XX + �.�28�.105. Заказа на винты с блокером опционным 3.3283.105 делать дополняя цифру 1 в последнюю часть каталожного номера винта транспедикулярного и добавляя каталожный номер блокера.ПРИМЕР: 3.XXXX.1XX + �.�28�.105.

*



IMPLANTS

Śruba przeznasadowa wieloosiowa (komplet)Transpedicular polyaxial screw (set)Транспедикулярный многоосевой винт (комплект)



[mm] Ø4 Ø5 Ø6 Ø725 �.�221.025 �.�222.025 �.�22�.025 �.�224.025�0 �.�221.0�0 �.�222.0�0 �.�22�.0�0 �.�224.0�0�5 �.�221.0�5 �.�222.0�5 �.�22�.0�5 �.�224.0�540 �.�221.040 �.�222.040 �.�22�.040 �.�224.04045 �.�221.045 �.�222.045 �.�22�.045 �.�224.04550 �.�221.050 �.�222.050 �.�22�.050 �.�224.05055 �.�221.055 �.�222.055 �.�22�.055 �.�224.05560 - �.�222.060 �.�22�.060 �.�224.06065 - �.�222.065 �.�22�.065 �.�224.065

Śruba przeznasadowa wieloosiowa z wysoką główką (komplet)Transpedicular polyaxial screw with high head (set)Транспедикулярный многоосевой винт с высокой головкой (комплект)

Wkręt blokującyBlocking screwЗажимной винт

3.3221.430



[mm] Ø4 Ø5 Ø6 Ø7�0 �.�9�4.0�0 �.�9�5.0�0 �.�9�6.0�0 �.�9�7.0�0�5 �.�9�4.0�5 �.�9�5.0�5 �.�9�6.0�5 �.�9�7.0�540 �.�9�4.040 �.�9�5.040 �.�9�6.040 �.�9�7.04045 �.�9�4.045 �.�9�5.045 �.�9�6.045 �.�9�7.04550 �.�9�4.050 �.�9�5.050 �.�9�6.050 �.�9�7.05055 �.�9�4.055 �.�9�5.055 �.�9�6.055 �.�9�7.05560 - �.�9�5.060 �.�9�6.060 �.�9�7.06065 - �.�9�5.065 �.�9�6.065 �.�9�7.065

Śruba przeznasadowa wieloosiowa rozporowa (komplet)Transpedicular spreading polyaxial screw (set)Транспедикулярный многоосевой распорный винт (комплект)

Nr katalogowy, Catalogue no., № по кат.

L [mm] Ø7 Ø8

�0 �.�227.0�0 �.�228.0�0�5 �.�227.0�5 �.�228.0�540 �.�227.040 �.�228.04045 �.�227.045 �.�228.04550 �.�227.050 �.�228.05055 �.�227.055 �.�228.05560 �.�227.060 �.�228.06065 �.�227.065 �.�228.065

Kolory Colors Ø 4 Ø 5 Ø 6 Ø 7

Kolory Colors Ø 4 Ø 5 Ø 6 Ø 7

Kolory Colors

Ø 7 Ø 8

50°

Ø

50°

Ø

�0°

Ø

L

L

L



IMPLANTS

PrętRod

Стержень

L[mm]

Nr katalogowyCatalogue no.

№ по кат.40 �.�245.04050 �.�245.05060 �.�245.06070 �.�245.07080 �.�245.08090 �.�245.090

100 �.�245.100120 �.�245.120150 �.�245.150180 �.�245.180200 �.�245.200250 �.�245.250�00 �.�245.�00�50 �.�245.�50400 �.�245.400500 �.�245.500

L

Zacisk łącznika poprzecznego (komplet)Clamp for crosswise connector plate (set)Зажим поперечного соединителя (комплект)

3.3278.005

Łącznik pręta wąski (komplet)Narrow clamp for crosswise connector rod (set)Узкий соединител для стержния (комплект)

6mm

6mm

L[mm]


№ по кат.45 �.�250.04550 �.�250.05055 �.�250.05560 �.�250.06065 �.�250.06570 �.�250.07075 �.�250.07580 �.�250.08085 �.�250.08590 �.�250.09095 �.�250.095

100 �.�250.100

Łącznik poprzecznyCrosswise connectorПоперечный соединитель

Łącznik prętowyRods connectorСтержень соединитель

L

Wkręt blokujący M6Blocking screw M6

Винт блокирующий M63.3273.001

Nakrętka okrągłaRound cap

Круглая гайка3.3281.005

Wkręt dociskowyCompressing screw

Болт прижимной - внутренний 3.3283.005

L

Łącznik boczny (komplet)Lateral connector (set)Боковой соединитель (комплект)

L

L[mm]


№ по кат.15 �.�254.01520 �.�254.02025 �.�254.025�0 �.�254.0�0

3.3275.005

Ø D[mm]

Ø d[mm]


№ по кат.5 5 �.�970.1556 5 �.�970.1656 6 �.�970.166

Ø D[mm]

Ø d[mm]


№ по кат.5 5 �.�970.0556 5 �.�970.0656 6 �.�970.066

Łącznik współosiowy (komplet)Axial connector (set)Соединитель осевой (кпл.)

D

d

Ø D

Ø d

L[mm]


№ по кат.�5 �.�257.0�540 �.�257.04045 �.�257.04550 �.�257.05055 �.�257.05560 �.�257.06065 �.�257.06570 �.�257.07080 �.�257.08090 �.�257.090100 �.�257.100

Łącznik równoległy (komplet)Parallel connector (set)Соединитель параллельный (кпл.)



INSTRUMENTS

III. INSTRUMENT SET FOR SPINE STABILIZER [40.4450.200]

Lp.Nr katalogowyCatalogue no.

№ по кат.Nazwa Name Название

Szt.PcsШт.

1 40.0�21 Wkrętak sześciokątny S 2,5 Hexagonal screwdriver S 2.5 Отвертка шестигранная S 2,5 12 40.4451.001 Marker I Marker I Маркер I 2� 40.4451.002 Marker II Marker II Маркер II 14 40.4451.00� Marker III Marker III Маркер III 15 40.445� Trokar Trocar Троакар 16 40.4456 Trokar uniwersalny Universal trocar Троакар универсальный 17 40.4471 Uchwyt zacisku Holder clamp Держатель зажима 18 40.4472.000 Dopychacz Pusher Толкатель 19 40.447� Klucz do śrub Wrench for screw Ключ для винтов 1

10 40.4477.100 Śrubokręt S4 Screwdriver S4 Отвертка S4 111 40.4498 Klucz kontrujący Counter wrench Ключ контр. 112 40.4499 Szczypce dystrakcyjne Forceps distraction Клещи для дистракции 11� 40.4501 Klucz do nakrętek długi Wrench for nut long Ключ гаечный, длинный 114 40.4512.000 Wyginak prawy Bending right Выгибатель правый 115 40.4512.100 Wyginak lewy Bending left Выгибатель левый 116 40.451� Przyrząd do gięcia pręta Device for bending bar Прибор для изгибания стержней 117 40.4516 Szczypce-trzymacze Forceps-holder Клещи держатели 118 40.4517 Klucz oczkowy Eye wrench Ключ гаечный накладной 119 40.5262 Szczypce kompresyjne Compression forceps Клещи компрессионные 120 40.5268 Sonda pedikularna Pedicle probe Транспедикулярный Зонд 121 40.5269 Klucz do śrub wieloosiowych Wrench for polyaxial screws Ключ для многоосевых винтов 122 40.4476.000 Uchwyt zacisku Holder clamp Держатель зажима 12� 40.4454 Pogłębiacz kształtowy Shape countersink Профильный зенкер 124 40.5254 Płytka do repozycji Reposition plate Пластина для репозиции 125 40.5274 Tuleja do repozycji Sleeve for reposition Втулка для репозиции 226 40.5270.800 Klucz dynamometryczny Torque wrench Динамометрическй ключ 127 40.5271 Grot S4 Screwdriver tip S4 Наконечник S4 128 40.5272 Grot S 5 Screwdriver tip S5 Наконечник S5 129 40.527� Grot do nakrętek Nuts tip Гаечный наконечник 1�0 40.5275 Manipulator widełkowy Fork persuader Манипулятор вилкообразный 1�1 40.4529.200 Statyw na instrumentarium Stand for instruments Подставка для инструментария 1

11. Klucz kontrującyCounter wrenchКлюч дожимательный [40.4498]

6. Trokar uniwersalnyUniversal trocarУниверсальный троaкар[ 40.4456]

9. Klucz do śrubWrench for screwsКлюч для винтов [40.4473]

15. Wyginak lewyBending left Выгибатель левый [40.4512.100]

14. Wyginak prawyBending right Выгибатель правый [40.4512.000]

1. Wkrętak sześciokątny S 2,5Hexagonal screwdriver S 2.5Отвертка шестигранная S 2,5 [40.0321]

2. Marker I, Marker I, Маркер l [40.4451.001]

3. Marker II, Marker II, Маркер Il [ 40.4451.002]

4. Marker III, Marker III, Маркер IIl [40.4451.003]

Ключ дожимательный

16. Przyrząd do gięcia prętaDevice for bending barПрибор для изгибания стержня[ 40.4513]

7. Uchwyt zaciskuHolder clampДержатель зажима [40.4471]



INSTRUMENTS

5. TrocarTrocarТроaкар [40.4453]

10. Śrubokręt S4Screwdriver S4Отвертка S4 [40.4477.100]

13. Klucz do nakrętek długiWrench for nut, longКлюч гаечный, длинный [40.4501]

18. Klucz oczkowyEye wrenchКлюч гаечный накладной [40.4517]

8. DopychaczPusherТолкатель[ 40.4472]

12. Szczypce dystrakcyjneForceps distractionКлещи для дистракции [40.4499]

12. Szczypce dystrakcyjneForceps distractionКлещи для дистракции

26. Klucz dynamometrycznyTorque wrench Динамометрическй ключ [40.5270.800]

27. Grot S4Screwdriver tip S4Наконечник S4 [40.5271]

24. Płytka do repozycjiReposition plateПластина для репозиции[ 40.5254]

25. Tuleja do repozycjiSleeve for repositionВтулка для репозиции[40.5274.000]

23. Pogłębiacz kształtowyShape countersinkПрофильный зенкер [40.4454]

30. Manipulator widełkowyFork persuader Манипулятор вилкообразный [40.5275]

28. Grot S5Screwdriver tip S5Наконечник S5 [40.5272]

29. Grot do nakrętekNuts tipГаечный наконечник [40.5273]



INSTRUMENTS

Kuweta na implantyCuvet for implantsКювета для имплантантов [40.4531]

Kleszcze do cięcia drutu Ø6,0Tongs for wire cutting Ø6.0Пассатижи для проволоки Ø6,0 [40.3175]

Kleszcze nie wchodzą w skład instrumentarium.Tongs are not a part of the instrument set.Пассатижи не входить в состав набора.

17. Szczypce trzymaczeForceps holderКлещи держатели[ 40.4516]

19. Szczypce kompresyjneCompression forcepsКомпрессионные клещи[ 40.5262]

20. Sonda pedikularnaPedicle probeТранспедикулярный Зонд[ 40.5268]

Kuweta nie wchodzi w skład instrumentarium.Cuvet is not a part of the instrument set.Кювета не входить в состав набора.

21. Klucz do śrub wieloosiowychWrench for polyaxial screwsКлюч для многоосевых винтов[ 40.5269]

Wyposażenie ponadstandardoweAdditional equipmentДобавочные оборудование

22. Uchwyt zaciskuHolder clampДержатель зажима [40.4476.000]

12

a)

b)

a)

b)

ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLANDtel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

SURGICAL TECHNIQUE

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

IV. SURGICAL TECHNIQUE

Decision concerning method of treatment is based on experiences of surgeon and medical center.

IV.1. Posterior lumbar and thoracolumbar approach

The patient is placed in the prone position (fig.a) with the support under the chest and the pelvis or proximal thighs. By minimizing pressure on the abdomen the intra-abdominal pressure is kept at a minimum thereby reducing intraoperative bleeding. Pillows or surgery frames can be used to al-low such decompression of the abdomen. The Tren-delenburg position (obtained with tilting of the operat-ing table) diminishes the blood loss even more. Existing frames ensure that the abdomen is hanging free with comfortable excursion of the chest and maintain lum-bar lordosis. Care must be taken on placing the head in the neutral position of the cervical spine and eyeballs protected from the pressure. Bony prominences (such as knees or anterior tibiae) as well as elbows should be thoroughly padded. Abduction of the arms should not exceed 90° to the trunk axis because of the risk of the brachial plexus injury. Positioning the patient with the legs extended may increase lumbar lordosis making some procedures such as laminectomy or lateral recess

decompression more difficult. Such position however reproduces the axial compression on the neural elements.

Knee-chest position (fig. b) reduces lumbar lordosis and allows a better access to the posterior spine elements and easier spinal ca-nal inspection (particularly at the spinopelvic junction). Before the skin incision the proper level and the direction of the pedicles should be determined with the image intesifier.

NOTICE: The knee-chest position cannot be used in case of stabilization of fracture.

A midline posterior incision is made, above tops of the spinous processes, which are exposed bilaterally. When approach to deman-ded vertebrae is reached, paraspinal musculature is retracted laterally.

NOTICE:

● head should be placed with the neutral position of the cervical spine which prese-rves the undisturbed blood flow in the vertebral arteries,

● eyeballs should be protected from the pressure and the corneas from the drying,● all bony prominences should be precisely padded,● abduction of the arms should not exceed 90°,● meticulous care should be taken to minimize the pressure on the abdomen and big

veins and to ensure free excursion of the chest.

1�

α

W


SURGICAL TECHNIQUE


IV.2. Screw selection. Locating the pedicle entry point

The principal signification is to select proper screw diameters for particular vertebrae and precise positioning of α angle and point of screws insertion1,2,�,4,5 , during pedicular screws application.The pedicles, depending on spine level, are geometrically and dimensionally diversified (e.g. the thoracic pedicle shape in the coro-nal plane appears irregular, kidney-shaped with the medial side convex).In connection with the above, preliminary selection of screw dimensions, i.e. diameter and length, must be done within the preope-rative proceeding, individual for each vertebra, with usage of TK-scans or fluoroscopy.A crucial matter at the selection of outer pedicular screw diameter is mediolateral outer width of pedicle (W).It should be kept in mind, that pedicle width described with fluoroscopy in coronal plane is not real dimension and should be taken as a rough guide. In general, the outer diameter of the screw should be about 2 mm smaller than width (W) of the pedicle.

Pedicle entrance point is placed at intersection of lines drown through the lateral aspect of the facet joints and middle of insertion of transverse processes.

NOTICE: All data contained in table 1 and 2 should be taken as a rough guide. The surgeon decide which diameter of trans-pedicular screw must be selected, relying on high-quality anteroposterior and lateral roentgenograms, as well as CT scans and intraoperative probing of pedicle.

Approximated transverse pedicle isthmus widths (W) for particular vertebrae are presented on ta-ble 1

Tab. 1. Transverse pedicle isthmus widths1.

Tab. 2. α angle values.

Approximated values of α angle (transverse pedicular angle, obtained by measuring the angle between a line through the axis of the pedicle and a line parallel to the vertebral midline in the transverse plane) are presented on table 2.

α[°]T1 27-�6T2 20-�4T� 18-24

T4-12 ~10L1 0-5L2 5-10L� 10-15L4 15-20L5 20-25

14

α

W

A

B

A

B


SURGICAL TECHNIQUE


There are two alternative trajectory for screw placement through the thoracic pedicles:A – anatomical trajectoryB – straight ahead trajectory.

The starting point is placed at intersection of an imaginary rostal caudal line 1 mm medial to the lateral edge of the lamina and line that is drawn through the medial of transverse processes, about 1 mm below facet joint.

NOTICE:

If anatomical trajectory of screw placement is performed, only the polyaxial screws can be used. If straight ahead trajectory is performed, both (polyaxial or monoaxial) screws may be used.

1 Campbell’s Operative Orthopaedics, Volume Two, p. 1570:1571, 1808:1810, Mosby; tenth edition, Philadelphia, 2002.2 P. Chaynes, J.-C. Sol, Ph. Vaysse, J. Bécue and J. Lagarrigue: Vertebral pedicle anatomy in relation to pediclescrew fi xation: a cadaver study, Surg Radiol Anat 23: 85-90, Springer-Verlag France 2001.� Daniel H. Kim, Alexander R. Vaccaro, Richard G. Fessler: Spinal instrumentation: Surgical Techniques,Thieme Medical Publisher, New York, 2005.4 AR Vaccaro, SJ Rizzolo, TJ Allardyce, M Ramsey, J Salvo, RA Balderston and JM Cobler: Placement of pediclescrews in the thoracic spine. Part I: Morphometric analysis of the thoracic vertebrae,J. Bone Joint Surg. Am. 77:119�-1199, 1995.5 AR Vaccaro, SJ Rizzolo, RA Balderston, TJ Allardyce, SR Garfi n, C Dolinskas and HS An: Placement of pediclescrews in the thoracic spine. Part II: An anatomical and radiographic assessment,J. Bone Joint Surg. Am. 77:1200-1206, 1995.

15

3

2

2

1


SURGICAL TECHNIQUE


Point of screw insertion should be prepared with the Trocar [40.4453] by perforating cortex layer of vertebral pedicle. Sometimes, to

achieve better pedicle exposure, removing lateral part of superior ar-ticular process of the vertebra may be performed with use a ron-geur forceps. The width of vertebral pedicle and an angle should be described before an operation with fluoroscopy or CT-scans. It allows to determine depth and angle of hole, which will be prepared for screw insertion as well as screw diameter.

1 Point of screw insertion should be prepared with the Trocar 11

With the Universal Trocar [40.4456], the previously made hole is deepen

gently by driving Trocar tip through thepedicle cortex walls, with a series of small swinging movements until anterior wall of the vertebral body is reached (or to de-sired depth, under fluoroscopy monitoring). The same procedure should be used to the other of vertebra pedicle.

2 With the Universal Trocar 22

Markers I, II or III [40.4451.001], [40.4451.002], [40.4451.003] should be inserted into previously prepa-

red holes. Lateral and A-P position during fluoroscopy con-trol allows verify correctness of insertion point, angle of the mar-ker position as well as hole depth to the anterior cortex of ver-tebra.

3 Markers I, II or III 33

NOTE: Before screw insertion, it is strongly recommended to confirm pedicle walls inte-grity with the Pedicle Probe [40.5268].

IV.3. Insertion of the screw - steps

2

2

16

4

4


SURGICAL TECHNIQUE


To determine appropriate screw length, the Universal Trocar [40.4456] is once again inserted into individual

hole until resistance of the vertebra wall is detected. Then the Universal Trocar Sleeve should be slid down until it touches the bone surface. The markings on the Trocar shaft, indicated by other side of sleeve, confirm appropriate screw length.

4 To determine appropriate screw length, the Universal 44

As an assistance during screws diameter and length selection, the markings on cuvet for implants [40.4531] can be used.

If needed, in order to prepare space for pedicle screw head, deepening the hole entrance by the Shape Co-

untersink [40.4454] could be performed. The pedicle screws are self-taping, therefore threading the holes is not need.

5 If needed, in order to prepare space for pedicle screw 55

17

6

7


SURGICAL TECHNIQUE


The appropriate screws (with proper chosen diameter and length) are driven into prepared holes by the Wrench

for Screws [40.4473].

NOTE: It is important to remember that proper screws alignment always must be performed by advancing the screws. Conical screws should not be backed out to adjust their depth, because it would cause screws an-chorage loss, and necessity of usage a screws with larger diameter may occur.

6 The appropriate screws (with proper chosen diameter 66

The screws insertion should be controlled in two planes with an image intensifier fluoroscopy.

The screw advancing should be stopped when position of the Wrench for Screws is parallel to the main axis of spine.

7 The screws insertion should be controlled in two planes with an image 77



SURGICAL TECHNIQUE


The rod should be bent in appropriate way to obtain required spine curvature (for instance lordosis or kyphosis). It is proceeded with two bending tools, the right [40.4512.000] and the left [40.4512.100], by putting the rod into appropriate recesses, which

the tools are equipped with, and than bent to demanded shape.The rod is inserted into screw recesses manually.

8 The rod should be bent in appropriate way to obtain required spine curvature (for instance lordosis or kyphosis). It is proceeded 88

To keep the rod position during bending process a hexagonal socket of the Eye Wrench [40.4517], sho-uld be inserted onto hexagonal tip at the end of the rod and than hold down.

The benders also enabling in situ rod correction.

The rod could be also shaped with the Device For Bending Bar [40.4513].

If needed, the rod could be cut to the appropriate length with the tongs [40.3175]. However, the tongs are non-standard equipment and they are not a part of the BIALSTAB instruments set.

19

9

10


SURGICAL TECHNIQUE


The screws locking is realized by applying compressing screw with ring [3.3283.105]. It should be po-sitioned onto the Screwdriver S4 [40.4477.100] and then inserted clockwise.

9 The screws locking is realized by applying compressing screw with ring 99

In case of difficulties with rod insertion into screw head bottom, the Pusher [40.4472] could be used.

NOTE: The locking screws should not be tightened at this stage.

If necessity of the rod derotation is indicated, the For-ceps-Holder [40.4516] can be used. In such case,

ones the required derotation is achieved, the construct should be locked at one point only, usually the middle of the construct, for the purpose of maintain appropriate po-sition. After that, additional reposition procedures (distrac-tion or compression) may be carried out.

10 If necessity of the rod derotation is indicated, the For-1010

20

11

40.4499 40.5262

L1

L2

40.5275

12


SURGICAL TECHNIQUE


At this stage, the distraction or compression procedures can be performed with usage of the Forceps Distraction [40.4499] or the Compression Forceps [40.5262]. Ones the required position of the vertebrae is achieved, the compressing screw is tighte-

ned by the Screwdriver S4.

NOTE: It is necessary to emphasize, that a very important stage of the surgical procedure is the rod contouring to appro-priate shape, which provides proper vertebrae reposition.

11 At this stage, the distraction or compression procedures can be performed with usage of the Forceps Distraction 1111

In case when vertebra reduction is needed, the Fork Persuader [40.5275] can be used. Ones the required vertebra position is achieved (it also means appropriate rod position into screws socket bottom), the locking components should be firmly tighte-

ned.

12 In case when vertebra reduction is needed, the Fork Persuader 1212

21

13

14


SURGICAL TECHNIQUE


The final locking can be performed with the Torque Wrench [40.5270.800], to obtain optimal tighten-

ing force; the appropriate replaceable tip of the torque wrench should be used (hexagonal S4 tip- [40.5271]- for compressing screws and the Nuts Tip - [40.5273]).

13 The final locking can be performed with the Torque 1313

Optionally, the construct locking can be performed at two stages by use the Compressing Screw [3.3283.205] and the Round Cup [3.3281.005].

The Compressing Screw and Round Cup should be positioned on holder of the Screwdrivers [40.4501] and [40.4477.100], mat-ched each other, and then positioned on pedicular screw head with align its axis.

14 Optionally, the construct locking can be performed at two stages by use the Compressing Screw 1414

Next, both locking elements should be lightly and simultaneo-usly inserted clockwise. The final tightening should be perfor-med after reduction procedures (derotation and distraction or compression), in first sequence by tightening the round cup with the Wrench For Nut Long [40.4501], next by tightening Compression Screw with the Screwdriver S4 [40.4477.100].

NOTE: The final tightening may be performed only when both locking elements are applied on screw head. Prior tightening one of the locking elements may cause defor-mation of arms of the screw head, consequently – im-possibility of screwing the other locking element.

22

15

16


SURGICAL TECHNIQUE


If two stages locking option is performed, the special set for reposition can be used. The threaded tip of the Sleeve for Reposition [40.5274] is apllied and screwed onto pedicular screws head. It is necessary to

have paid attention that the rod should not been pressed by sleeve during the procedure.After that the reposition of vertebrae is proceeded manually under fluoroscopy control. Ones the required of vertebrae position is achieved, the internal locking component is tightened by the Screwdriver S4 to maintain appropriate position.

15 If two stages locking option is performed, the special set for reposition can be used. 1515

If it is needed, to ensure rota-tional stability during locking

procedure, the Counter Wrench [40.4498] can be used.

16 If it is needed, to ensure rota-1616

The sleeve for reposition has a row of grooves throughout its length, which allows to mount on it the Reposition Plate [40.5254]. Such a combine set works as a lever, allowing to use less strength during vertebrae correction procedure.

Next, once the sleeves are removed, the Round Cups [3.3281.005] should be applied on screws head and then finally tightened with [40.4501] the Wrench For Nut Long.

2�

17

18


SURGICAL TECHNIQUE


If osteosynthesis involves more than three vertebrae, a difficult to curve the rod to make it fit into the bottom of each screw could be occurred.

In such case the screws with high head (long arms) may be helpful. By pla-cing alternately a few of these screws, the rod can be easily pushed down into proper position with the locking screw.

17 If osteosynthesis involves more than three vertebrae, a difficult to curve 1717

When extension of the construct to lateral direction (in relation to main axis) is needed, it is possibility of applying the lateral (offset) Connec-

tor [3.3254]. The Connector should be slipped onto the main rod, and then tightened in demanded position with the Screwdriver S4 [40.4477.100] (after prior mounting with it the pedicular screw).

If connecting of two parts of rod is needed (e.g. in case of scoliosis stabiliza-tion) the rod connectors can be used:● axial connector● parallel connector.

18 When extension of the construct to lateral direction (in relation to main 1818

The screw arms are broken off at the end of surgi-cal procedure with the Forceps-Holder [40.4516].

NOTE: The procedure described above may cause excessive pedicular screw lift (and unintentional vertebra reduction). To prevent this, the in situ correction of rod curvature must be performed.

24

�.�275.005

�.�257

19

20

�.�250

�.�278.005


SURGICAL TECHNIQUE


IV.3.1. Crosswise connectors

The BIALSTAB System provides possibility of increased rotational stability, by cross-linking of both rods by:

• the Rod Connector [3.3257], which is assembled with the Clamps [3.3275.005], seated on the main rod,

• the Tabular Crosswise Connector [3.3250], which is assembled directly with the Clamps for [3.3278.005], seated on the main rod.

• the Tabular Crosswise Connector [3.3250], which is assembled directly with pe-dicular screws.

NOTE: The use of the Tabular Crosswise Connector, mounted on pedicular screws is possible only when two stages locking option is chosen (round cup and compression screw). Application of the Tabular Cros-swise Connector (because of their width) is recommended in case, when fixation with spinous process removal or laminectomy is car-ried out.

The Holder Clamp [40.4471] simplifies manipulation during Connectors as-sembling procedure. The Rod Connector is applied into Clamp [3.3275.005]

body in that way, so that its flat surface been laid against the main rod and then is locked by screwing in compression screw (which is in-set) with the Hexagonal Screwdriver S2.5 [40.0321]. The older type of the Clamp [3.3276.005] assembly should be carried out with the Holder Clamp [40.4476] and the Screwdriver S4 [40.4477.100].

19 The Holder Clamp 1919

The Tabular Crosswise Connector, before assembling, to obtain required shape may be contoured by the Bendings [40.4512.000] and [40.4512.100].

Next, the Tabular Connector is applied onto clamp. The Clamps, which are seated on main rods and then screwed with the Round Cap with the Wrench For Nut Long [40.4501]. The Connector Clamp should be additionally locked by Compression Screw (which is in-set) with Screwdriver S4.Optionally, the Tabular Crosswise Connector may be mounted directly on the pedicular screw heads and fastened also by the Round Cup.There is possibility of angular alignment of the Crosswise Connector in relation to the Stabilizer Rod, up to 20° if it is assembled with pedicular screw and up to 15° if it is as-sembled with the Clamps.

20 The Tabular Crosswise Connector, before assembling, to obtain required shape 2020

25

2121

�0°

22

23


SURGICAL TECHNIQUE


Appliance of polyaxial screws allows to fit position of a screw head in relation to the Rod, es-pecially in cases of non-parallel position of screws. It gains screw-rod connection stability

and cause that complicated rod bending is not longer required. The polyaxial screw has 15° range of motion in any directions.

21 Appliance of polyaxial screws allows to fit position of a screw head in relation to the Rod, es-2121

The polyaxial screw with appropriate size is driven into prepared hole of the vertebra

pedicle by the Wrench For Polyaxial Screws [40.5269].

22 The polyaxial screw with appropriate size The polyaxial screw with appropriate size 2222

The polyaxial screw is positioned on the wrench holder. Hexagonal tip of the Screwdriver S5 is applied into screw socked and then holder body is slid down until its tip clicks into screw head.

NOTE: The locking screw must be screwed in with its blue-colored surface oriented up.

Locking of the screw head if performed by screwing in the loc-king screw with the Wrench For Polyaxial Screws [40.5269].

The locking screw is positioned onto hexagonal S5 tip and then holder body should be slid down. The locking screw positioned like this is applied in polyaxial screw head and then is tighten clockwi-se.

23 Locking of the screw head if performed by screwing in the loc-2323

IV.3.2. Polyaxial screws

26

24

�0°

25

26


SURGICAL TECHNIQUE


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.

IV.3.3. Spreading screws

The pedicular spreading screws are used in cases, when stable fixation is not possible becau-se of advanced osteoporosis.

The spreading screw is equipped with special mandrel, which cause spreading of the screw shaft arms when it is tightened and as a result– screw fixing in trabecular bone.

NOTE: The pedicular spreading screws are not intended to use with a bone cements.

24 The pedicular spreading screws are used in cases, when stable fixation is not possible becau-2424

There is a necessity of drilling holes with the Cannulated Drill. Under X-ray monitoring, the K-wire [40.4452] is driven into vertebra and then left inside hole. The Cannulated Drill (Ø5/ Ø2,2

[40.2043] – for 7 mm spreading screw or Ø6/ Ø2,2 [40.4584] – for for 8 mm spreading screw) is applied onto K-wire. Next, the hole is drilled, guided trough the K-wire. Once the K-wire and drill are removed, the spreading screw can be inserted.The procedure of the spreading screws insertion is the same, like described in point [6]-[7], whereas the procedure of the polyaxial spreading screws insertion is the same, like described in point [22].

25 There is a necessity of drilling holes with the Cannulated Drill. Under X-ray monitoring, the K-2525

The spreading of the screw shaft arms and fixing into vertebra is carried out by screwing clockwise the mandrel, inserted into

screws hole, with the Hexagonal Screwdriver S2.5 [40.0321]. The final locking of the spreading screw is performed the same way, as it was described in point [9]-[14], whereas the procedure of the po-lyaxial spreading screws locking is the same, like described in point [23].

26 The spreading of the screw shaft arms and fixing into vertebra 2626

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]

4 Intramedullary osteosynthesis of humerus7 Intramedullary osteosynthesis of fibula and forearm6 Intermedullary osteosynthesis of femur by trochanteric nails8 Dynamic Hip (DSB)/ Condylar (DSK) stabilizer9 Spine stabilization CHARSPINE

15 Tibial and femoral angular set block20 Radial Head Prosthesis KPS22 Locking plates23 Intramedullary osteosynthesis of femur (reversed method) 40.366024 Intramedullary osteosynthesis of femur 40.5060.00025 Intramedullary osteosynthesis of tibia 40.5370.50028 Intramedullary osteosynthesis of femur by trochanteric nail - ChFN29 Cervical locking plate system30 Proximal humeral plate32 4.0 ChLP plates for distal part of radial bone35 Spine stabilization [6mm]36 ChLP screws removing37 Stabilization of the pubic symphysis38 Intramedullary tibia osteosynthesis with ChTN nails

instruction - rimanererimanere.com.mx/pdf/tecnicas/9_stabilizacja_kregoslupa_en.pdfchm ltd.,...

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