FH ORTHOPEDICS be POD TYLOS Arthrodese-Nail User manual

FOOT
TYLOS
ANKLE
ARTHRODESIS NAIL

2
TYLOS
1 – Installing the patient making sco-
pic control possible (in prole)
INDICATIONS
The TYLOS™ nail is used in cases of combined talocrural and subtalar arthrodeses,
as well as in certain forms of distal pseudarthrosis of the tibia when the ankle joint
cannot be preserved.
Length: 160, 200, 250 mm
Side locking with
a cortical screw
Posterior locking with a wedge-
type trans-calcaneal screw
The TYLOS™ ankle arthrodesis nail from the Be POD™ range has
a unique posterior locking system, thanks to implantation of a
trans-calcaneal screw of the threaded wedge type. This gua-
rantees considerable stability and thus reduces the risk of
disassembly of the system or migration of the screw.
INSTALLING THE PATIENT
The patient is placed in dorsal decubitus.
The leg to be operated is moved out of line and
raised in relation to the controlateral leg so as to
allow prole controls with the X-ray image inten-
s i  e r (Fig. 1).
• Cannulated nail, available in :
-3 lengths : 160, 200, 250 mm
-3 diameters : 10, 11, 12 mm
•Material : Stainless steel
• Multi-axial stabilisation
-1 single wedge-type trans-calcaneal screw guarantees
excellent mechanical stability – POSTERIOR FIXATION
-3 to 4 laterally-attached cortical screws – LATERAL FIXATION
•Wide range of trans-calcaneal and cortical screw sizes
•Protective plug
•Simple and precise instrumentation
•Drill guides designed for easy control
using X-ray image intensier

3 - Mini-invasive approach
for subtalar avivement
3
Tylos TM
TALOCRURAL APPROACH
In certain exceptional cases, and providing that the surgeon is used to it, this
approach may be done through an arthroscopic procedure. In most cases,
the recommended procedure a standard anterior approach made between
the tendons of the anterior tibial and the common extensor tendons after
sectioning the retinaculum of the extensors, whilst respecting the foot’s dor-
sal pedicle (Fig. 2).
After arthrotomy, the joint is approached for freshening of the articular sur-
faces, respecting as much as possible their geometry and insisting on the
malleolar sulci using a drill and a set of curettes of increasing size.
Depending on whether there is loss of bone substance, lling by means of an
autograft and/or bone substitute is of course possible. It is also recommended
that any axis deformity be corrected as the nail will only be introduced into a
hindfoot with a normal axis.
SUBTALAR APPROACH
This is indispensable. It is perfectly do-able using a mini-invasive approach via
the lateral orice made in the projection of the tarsal sinus (Fig. 3).
The cartilage of the subtalar joint can be freshened in the same way, using a
set of curettes of increasing sizes and a drill, under uoroscopic control.
After these two procedures, it must be possible to realign the hindfoot easily.
PLANTAR APPROACH (Point of introduction of the nail)
By means of a short approach made in the axis of the 4th radius,
just before the heel strike, the inferior face of the calcaneus is
approached (Fig. 4).
To be sure to be in the right position on the plantar cortical
(which is not very wide) of the calcaneus, it is recommen-
ded that it be palpated. The cannulated obturator
(ref. 253258) placed in the soft tissue
protector (ref. 253247) is put into
position in contact with the
bone to make it possible to
insert the threaded tip pin
(ref. 253244)in place.
2 - Approach – Talocrural and anterior exposure
4 – Introduction point – Using the trocar point

4
It is mounted on the motor and introduced in an ascending, transosseous
manner, controlling its insertion on the image intensier (Fig. 5).
It must be positionned exactly in the centre of the tibial pilon, both face on
and in prole, with the hindfoot in its axis. The choice of introduction point
for the nail must be made very carefully as the nail cannot and must not re-
duce the hindfoot automatically.
The cortical bones are hollowed out (Fig.6) using a cannulated drill bit (ref.
253264)before inserting the hand reamers (ref. 253248, 253249 and
253250).
The length of the nail can be read using the graduations on the reamer in posi-
tion, as a projection of the external orice of the retractor (Fig. 7).
At this stage, it is recommended that the threaded tip pin be replaced by a
smooth key wire (ref. 253245). Reaming is performed size for size. It is possible
to use a mechanical reamer in cases of bone resistance or proceed this way if
you are used to.
IMPLANTATION OF THE NAIL(Fig. 8)
The nail, the diameter and length aof which were determined previously, is
assembled on the main xation nail holder (ref. 253246), to which it is joined
by the M6 connecting screw (ref. 253251).
Depending on whether it is a right (R) or left (L) foot, the notch (R) or (L) in the
holder is placed opposite the arrow marked on the nail. The posterior guide is
joined to the holder by the M5 screw (ref. 253681), using the posterior face of
the nail marked B (back) as the orientation mark.
Before introducing the nail, it is recommended that the leg be raised by
means of a block or a pile of folded sterile drapes so as not to be hindered
by the posterior axis of the main xation nail holder. This is introduced on the
foam stem guide (ref. 253245), and crosses the subtalar and talocrural interli-
nes. The nail must be pushed in with the hammer, maintaining the correction
in the axis of the hindfoot, so that its distal extremity, visible on the image
intensier, lightly touches the inferior cortical of the calcaneus (Fig. 9).
5 - Implantation of the threaded
pin with the motor
6 - Introduction of the cannulated drill
bit – Hollowing the cortical bones
7 - Introduction of the hand reamers
8 – Assembling the TYLOS™
posterior drill guide
9 - Introduction and implantation
of the nail
253264
253244
253258
253247
253248
253249
253250
253251
253246
254596
253681
254635

5
Tylos TM
POSTERIOR LOCKING
The soft tissue retractor (ref. 253252) is assembled in the guide for trans-cal-
caneal screws (ref. 253261), and screwed into the centering guide sleeve (ref.
253256). A small posterior skin incision is made to introduce the entire assem-
bly into contact with the bone (Fig. 10).
After withdrawing the soft tissue retractor and distal screw guide, packing
with drill bit M6 (ref. 253259) is performed until the nail is blocked. Measured
length A (which corresponds to the measurement of the posterior part of the
screw) will be retained by direct reading on the graduation at the level of the
posterior orice of the centering guide sleeve (Fig. 11).
The drilling sleeve for the 3.5 drill bit (ref. 253254) is then assembled in the
centering guide sleeve that remains in place and makes packing the anterior
part of this drill bit possible (ref. 253257). The position of the extremity of the
drill bit can be controlled via uoroscopy. After installing the blue measure-
ment indicator (ref. 253635) on the posterior guide, length B is read directly
(Fig. 12) in the window designed for this purpose (and which corresponds to
the anterior part of the screw).
It is also possible to use the red measurement indicator (ref. 255441) which is
placed on the drill, directly at the level of the graduation desired, and makes
precise drilling possible, as dened beforehand.
If the position of the nail does not make it possible to guarantee a minimum
distance of 10 mm between the nail and the anterior cortical of the calcaneus,
length B will be zero and this nal step will not be necessary.
Remark : In case of calcaneal-cuboid arthrodesis, xation is possible using
this trans-calcaneal screw, the anterior length of which will then be 20 mm
or more, but after having freshened the interline percutaneously, with uo-
roscopic control, and a Wedge 4.1 burr (ref. 256017) or, in a more classic
manner, in the open air.
The trans-calcaneal screw will thus have as its denitive length the associa-
tion of the measurements of the posterior (A) and anterior (B) portions.
For example, a 10/45 screw corresponds to an anterior portion at the front of the
nail of 10 mm and a posterior portion at the back of 45 mm.
The guide for the drill bit is replaced by that of the screw (ref. 253261) so as
to introduce the chosen screw on its screwdriver (ref. 257381). The screw will
be tightened until completely blocked (Fig. 13).
It is recommended that the head of the screw be plugged
by means of a small polyethylene plug, positioned
on the square point.
10 - Implanting the trans-calcaneal screw
11 - Drilling
posterior part A
12 - Drilling
anterior part B
13 – Implantation of the
trans-calcaneal screw
TYLOS™ trans-calcaneal screw
2532261
253252
253256
253259
255441
254635
253257
253254
257381
253261

6
LATERAL LOCKING
The posterior guide is removed to introduce the lateral guide on to the 2nd
branch of the xation nail holder, held in place by screw M5 (ref. 253681).
A maximum of three proximal, and two distal, screws can be used. Markings
indicate the holes to be used depending on the length of the nail (160 or 200
mm classically; a specic lateral guide is delivered with the optional 250 mm
nail) (Fig. 14).
The procedure for percutaneous implantation is the same for each: assemble
the soft tissue retractor (ref. 253252) in the screw guide sleeve (ref. 253261)
and screw it into the centering guide sleeve (ref. 253256).
After a small skin incision, introduce the whole assembly until it comes into
contact with the bone (Fig. 15).
Once the soft tissue protector and screw guide sleeve have been removed,
assemble the guide for the 3.5 drill bit (ref. 253254) in the centering guide
sleeve that has remained in place and which allows cortical drilling (Fig. 16).
Direct reading of the graduations on the drill bit blocked on the second cor-
tical determine the length of the screw required.
If you estimate that the head will really stick out too much under the skin, it is
possible to countersink the cortical bone with 6/3 drill bit (ref. 253262) until
it is blocked (Fig. 17).
After removing the drill bit guide sleeve, it is possible to obtain a standard
measurement using the screw depth gauge (ref. 253260). The screw is intro-
duced into the centering guide sleeve on its screwdriver (ref. 257381) (Fig. 18).
In order to guide the screwdriver better, and once the screw is engaged in
the centering guide sleeve, it is possible to use again the guide sleeve for
calcaneal screws (ref. 253261).
The entire nail holder is then removed.
17 – Countersinking to embed the
cortical screws
15 - Lateral locking
16 - Drilling for cortical screws 18 - Screwing of cortical screws
14 - Assembling the TYLOS™ im-
plantation guide - Lateral drill guide
200 mm
160 mm
253252
253261
253256
253257
253254
253262 257381
253261

7
TYLOS
Tylos TM
EXTRACTION OF THE MATERIAL
The lateral screws are simply unscrewed once the approach has been retur-
ned to (ref. 257381).
The polyethylene plug protecting the head of the calcaneal screw is cleared,
making it possible to screw its extractor into place (ref. 254597). The extractor
is screwed in backwards, making it initially possible to connect it to the screw
and then, when it reaches its blocking point, to unscrew it in a second stage
(Fig. 20).
For the nail, once you have returned to the plantar approach, screw in the M6
connection screw (ref. 253251) on to which the nail extractor (ref. 254597)
and its counterweight (ref. 255440) can be connected.
Remark : Make sure to maintain a lateral screw in position so as not to push
it into the tibia.
20 - Extraction of the TYLOS nail
255440
254597
253251

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◊ - FH ORTHOPEDICS -200809 - pt_tyl08_ev1 - Illustrations : © Marc Donon
geco-medical.org
TYLOS
TYLOS™ , a product in the Be POD™ range,
is under permanent evaluation by the members of the TALUS group of
GECO, a study group for foot surgery.
www.geco-medical.org
FH ORTHOPEDICS S.A.S
3 rue de la Forêt - F 68990 HEIMSBRUNN
Tél. [phone] / Fax : [phone]
e-mail : [e-mail]
www.fhorthopedics.fr
USA, FH ORTHOPEDICS INC.
3735 West Belmont Avenue
Chicago, Illinois 60618
Tel.: [phone] / Fax : [phone]
e-mail : [email protected]
POLSKA, IMPLANTS INDUSTRIE
Oddzial w Polsce60-171
Poznań, ul. Paczkowska 26
Tel : [phone] / Fax : [phone]
e-mail : fh.or[email protected]
distributed by :
253 228 Ø 10 lg 160
253 229 Ø 11 lg 160
253 230 Ø 12 lg 160
253 231 Ø 10 lg 200
253 232 Ø 11 lg 200
253 233 Ø 12 lg 200
254 632 Ø 10 lg 250 (option on request)
254 633 Ø 11 lg 250 (option on request)
254 634 Ø 12 lg 250 (option on request)
254 581 lg 0-35
254 582 lg 0-45
254 583 lg 0-55
254 584 lg 10-35
254 585 lg 10-45
254 586 lg 10-55
254 587 lg 20-35
254 588 lg 20-45
254 589 lg 20-55
TYLOS™ ankle nail TYLOS™ trans-calcaneal screw
254 590 lg 30-35
254 591 lg 30-45
254 592 lg 30-55
254 593 lg 40-35
254 594 lg 40-45
254 595 lg 40-55
FH ORTHOPEDICS References
253 239 Ø 5 lg 25
253 240 Ø 5 lg 30
253 241 Ø 5 lg 35
253 242 Ø 5 lg 40
253 243 Ø 5 lg 45
255 467 Ø 5 lg 50
255 468 Ø 5 lg 55
TYLOS™ cortical screw
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TYLOS™ ankle arthrodesis nail ancillary
lg B - A
253 244 Pin with threaded tip
253 245 Smooth key wire lg 600 mm
253 246 Main xation nail holder
253 247 Soft tissue protector
253 258 Cannulated obturator
253 248 Hand reamer Ø 10 mm
253 249 Hand reamer Ø 11 mm
253 250 Hand reamer Ø 12 mm
253 251 Connecting screw M6
253 252 Soft tissue retractor
257 381 6 bladed screwdriver 3.5 mm
248 476 Trocar point
253 256 Centering guide sleeve Ø 10 mm
253 254 Guide sleeve for drill bit dia 3.5 mm
253 261 Guide sleeve for trans-calcaneal screw
253 255 Lateral guide
254 596 Posterior guide
253 681 Connecting screw M5
253 257 AO Drill bit Ø 3,5mm
253 259 AO Drill bit Ø 6mm
253 260 Screw depth gauge
253 262 6/3 Drill bit for cortical screw
253 264 Cannulated drill bit for nail
254 635 Blue measurement indicator
255 441 Red measurement indicator
254 636 Long nail guide (length 250 mm)
254 637 Screw for long nail guide
254 598 Ø 3.5 mm pin grip
254 597 Extractor axis for the nail and
trans-calcaneal screw
255 440 Conterweight
257 399 TYLOS™ ancillary basket