Transcript Document

Orto Tech Design Ltd.
RIGID MONOFIXATOR
MODEL ‘RAPID’
TITLE PAGE OF THE PATENT
GENERAL
The Rigid Monofixator is designed for orthopaedics and
thraumatic surgery and is applied in treatment of long
tubular bones.
The fixator is the fastest way of stabilizing, using the
method of remote osteosynthesis of two fragments with tightening of just one nut, a reliable fixation is
achieved with unlimited number of bone screws.
ADVANTAGES

Simple, reliable, light, versatile system.

Effective in healing of different types of displaced fractures

Very easy to apply within a short operative period.

Ensures hopeful fixation in fractures in reduction position.

Universal with respect to the choice of implant screws - it allows
tightening of screws from 3 mm to 6 mm in diameter.

Opportunity to choose freely where to mount the screws: quite near the
fracture line and as far from it as possible. Thus long carrying arms can
be formed ensuring maximum stability on the axis.

Isolator property achieved by hard anodized coating with Al2O3
DESIGN
The design of the fixator is
compact and has been
simplified to the highest
degree,
allowing
quick
immobilization of moving
bone fragments. The fixator
contains of a carrier, shaped
as a thin-wall tube (2),
containing a body (1) with
holes, shaped in it. Bone
screws (3) are fixed in (A)
and (B) holes by means of a
nut (4). Thus remote rapid
ostheosynthesis is achieved.
The body can move axially in
relation to the tube, but it
cannot turn around. This is
assured by a pin (5) which
moves in a groove .
SCREW DESIGN
1
2
3



Implant screws are combinations of a
drill 1, screw tap 2 and screw 3. That
allows screws to be fixed into the
bone without preliminary preparation.
At the beginning the screw is with an
arc profile that slightly turns into
cylindrical one.
The threading of the screw is with a
special self-locking profile that
ensures the preservation of maximum
osseous tissue.
The end of the screw is with a
triangular profile that allows fitting to a
wrench with the same profile or to a
three-jaw chuck.
APPLICATION AREA
The Rigid Monofixator could be applied in following
cases:

open and closed fractures in different places;

single and multiple fractures;

in-joint and out-joint fractures;

fractures with infections;

unhealed fractures and complex joints (pseudoarthrosis);
APPLICATIONS
PHALANGES FRACTURES
APPLICATIONS
PHALANGES FRACTURES
APPLICATIONS
JAWS FRACTURES
APPLICATIONS
ANTEBRACHIUM AND HUMERUS FRACTURES
APPLICATIONS
TIBIA AND FEMUR FRACTURES
OPERATING MANUAL
PREPARING STAGE
1. Operation planning
2. Before the operation, concerning the plan, the orthopaedic surgeon
chooses the necessary modules from the set and prepares them for
sterilisation.
3. Sterilisation is done according to the instructions:
Sterilisation approach
Under pressure
Termal
With X rays
With gas
Chemical
Implants
Yes
Yes
Yes
Yes
Yes
Fixators
Yes
No
Yes
Yes
Yes
Instruments
Yes
Yes
Yes
Yes
Yes
4. Fixators are arranged on a surgical table, in accordance with
technology, described in the operation plan.
5. Treat the patient.
OPERATING MANUAL
OPERATING WITH THE SET ‘RIGID MONOFIXATOR’
Depending on the position, character and complexity of a particular fracture, the
necessary number of screws are inserted in the bones so that they should be
against the holes of the fixator. Two of them are placed over and under the fracture
line, in the fracture area, the rest are placed as far from the fracture as possible.
Guiders and protectors are used for more precise insertion and protection of the soft
tissues from additional damage and traumata.
The screws should pass through the whole bone, but they shouldn’t penetrate into
the opposite soft tissue.
After the screws’ insertion, the fixator is strung on the protruding screw stems and
the fixator nut is tightened. Thus all the screws are tightened simultaneously and the
bone fragments are stabilized. Because of the parallel misalignment of the screws
increased solidity of tightening is achieved as a result of the wedging.
OPERATING MANUAL
OPERATING WITH THE SET ‘RIGID MONOFIXATOR’
screwing a screw
strunging a fixator
tightening
OPERATING MANUAL
CHOOSING THE NECESSARY SCREWS
Depending on the volume, size and strength of the broken bones, we propose a
method for choosing the appropriate screws based on the following principle: not
more than one third of the local bone thickness:
Bone

Phalanges of the hands and feet /metacarpal,
Screw diameter [mm]
2 or 3
metatarsal, heel bones/

Radius and ulna
3 or 4

Distal epiphysis of radius and proximal epiphysis of ulna
4 or 5

Distal epiphysis of humerus

Diaphyasis and proximal metadiaphyasis of humerus

Femur
5 or 6

Pelvic bones
5 or 6
4
4; 5 or 6
MODULES
SET FOR UPPER EXTREMITY
cat. №
803000
803000-01
803000-02
803000-03
803000-04
803000-05
Name
Module with 9 holes
Module with 11 holes
Module with 13 holes
Module with 15 holes
Module with 17 holes
Module with 19 holes
MODULES
SET FOR LOWER EXTREMITY
cat. №
803100
803100-01
803100-02
803100-03
803100-04
803100-05
803100-06
Name
Module with 9 holes
Module with 11 holes
Module with 13 holes
Module with 15 holes
Module with 17 holes
Module with 19 holes
Module with 21 holes
MODULES
SET OF MINIFIXATORS
cat. №
803200
803200-01
803200-02
803200-03
803200-04
803200-05
803200-06
Name
Module with 4 holes
Module with 5 holes
Module with 6 holes
Module with 7 holes
Module with 8 holes
Module with 9 holes
Module with 10 holes
SCREWS
cat. №
Name
700200-02
700200-03
700200-04
700200-05
700400-01
700400-03
700400-05
700400-07
700400-09
700500-01
700500-03
700500-15
700500-07
700500-09
700500-11
700500-13
700500-15
Ø 4 mm L 80/20
Ø4 mm L 90/20
Ø4 mm L 100/25
Ø4 mm L 110/25
Ø5 mm L 90/30
Ø5 mm L 100/35
Ø4 mm L 110/35
Ø5 mm L 120/40
Ø5 mm L 130/45
Ø6 mm L 90/30
Ø6 mm L 100/35
Ø6 mm L 110/40
Ø6 mm L 120/40
Ø6 mm L 130/40
Ø6 mm L 140/40
Ø6 mm L 150/45
Ø6 mm L 160/50
CANNULATED SCREWS
cat. №
Name
700600-01
700600-03
700600-05
700600-07
700600-09
700600-11
700600-13
700600-15
Ø6 mm
Ø6 mm
Ø6 mm
Ø6 mm
Ø6 mm
Ø6 mm
Ø6 mm
Ø6 mm
L 90/30
L 100/35
L 110/40
L 120/40
L 130/40
L 140/40
L 150/45
L 160/50
KIRSHNER WIRE WITH ROUND END
cat. №
790100
790100-01
790100-02
790100-03
Name
Ø1.5 mm
Ø2.0 mm
Ø2.2 mm
Ø2.2 mm
L 70
L 70
L 70
L 70
INSTRUMENTS
INSTRUMENTS
cat. №
900100-01
900100-08
900100-09
900300
905100-01
905100-02
905100-03
909200
901400
901500
922100-01
922100-02
922100-03
923000-01
923000-02
923000-03
Name
qty.
Wrench 8
1
Wrench 15
1
Wrench 17
1
Blocking bar
1
Screw wrench Ø 4
1
Screw wrench Ø 5
1
Screw wrench Ø 6
1
Wrench for trocars and protectors 1
Guide
1
Guide for Kirshner wires
1
Protector short Ø 4
4
Protector short Ø 5
4
Protector short Ø 6
4
Trocar Ø 4
4
Trocar Ø 5
4
Trocar Ø 6
4
CLINICAL CASE #1
R.A. 28 year old, d.r. No 1145/28.10.1995
Dg. Osteomielitis femuris hronika fistulosa. Fistula.
Chronic thraumatic purulent osteitis of the
femur after intramedular osteosynthesis a
modo Kuntscher. Engagement of the medular
canal and unstable synthesis is seen from
the fistulo-graphia. Micrbiologic examination staphylococcus pureus. Strong necessity of
external fixation and removing the nail. The
medular canal is strip-drilled and cleaned
with antiseptic solutions. Gentamycin pearls
(PMMA) are mounted for preparing of the
implantation place. After fistulectomia the
wound is closed hermetically.
CLINICAL CASE #1
CLINICAL CASE #1
Redon drainage in the canal
from the proximal femur. On the
20 th day PMMA are removed
and the place is filled with graft
from spina ilacia anterior
superior, and the donor place is
filled with graft from the bone
bank /Popkirov/. Redon
drainage for 7 days. Smooth
postoperative period. Early limb
loading. Infection - under
control.
CLINICAL CASE #1
Five months later
roentgenography shows graft
reconstruction. Bone defect
recovery. Removed external
fixator. Full rehabilitation.
Excellent results.
CLINICAL CASE #1
CLINICAL CASE #1
Indications:
1. Corrupted intramedular synthesis.
2. Thraumatic purulent osteitis.
3. Wide access to the wound, allowing
second operation and wound observation.
4. Early moving of neighbour joints.
CLINICAL CASE #2
CLINICAL CASE #2
CLINICAL CASE #2
CLINICAL CASE #2
CLINICAL CASE #2
CLINICAL CASE #2
CLINICAL CASE #2
CLINICAL CASE #2
Contacts
Orto Tech Design Ltd.
Bulgaria
9300 Dobrich,
Tel./Fax +359 59 620120
E-mail: [email protected]
Dr. Stanislav Nestorov MD
GSM +359 897 969161
Slavyanska 10