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O rto T ech D esign Ltd.

O rto T ech D esign Ltd. SYSTEM FOR AXIAL EXTERNAL FIXATION "NESTOROV". UNDERLYING OWN PATENTS. Title page of the patent 100327 / 31.01.96 ‘External fixator’. Title page of the patent 100328 / 31.01.96 ‘Adjustable connection between elements for external fixation ’.

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O rto T ech D esign Ltd.

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  1. Orto Tech Design Ltd. SYSTEM FOR AXIAL EXTERNAL FIXATION "NESTOROV"

  2. UNDERLYINGOWN PATENTS Title page of the patent 100327 / 31.01.96 ‘External fixator’ Title page of the patent 100328 / 31.01.96 ‘Adjustable connection between elements for external fixation’

  3. “Universal, extremely simple and incredibly strong... • This is the “Kalashnikov” • in the external fixation.” prof. Kukuruz J. S. Chief of Department of Traumatology of the Institute of Accident Medicine, Kiev, Ukraine; Former main front traumatologist in Afghanistan

  4. PURPOSE • System for axial external fixation is designed for orthopaedics and thraumatic surgery and is applied in treatment of long tubular bones. • It represents a system of modules which when mounted form a multi - functional external construction. • By means of this system, repositioning of bone fragments can be achieved; moreover, bone fragments can be immobilized in that position for a certain period by means of building an external supporting construction connected with the screws implanted in the bones.

  5. APPLICATION AREA • The system for external fixation "Nestorov" could be applied in the following cases: • open and closed fractures in different places; • single and multiplex fractures; • in-joint and out-joint fractures; • fractures with infections; • unhealed fractures and complex joints /pseudoarthrosis/; • shortened extremities.

  6. APPLICATION AREA

  7. APPLICATION AREA

  8. CONTENT • The system for external fixation "Nestorov" includes: • set of different /in construction/ metal items (fixators), which could be joined to each other and form an external frame with multiple functions and different strength, in dependence of the place and purpose. • metal screws, different in diameter and length, which are designed for implantation in bones. • instruments, necessary for working with the system.

  9. PURPOSE OF THE MAIN MODULES • The metal frame of the external fixator consists of the following main modules: • screw holder– fastens the implant screws, allowing compressionor distraction of bone fragments thanks to the fixation of the screws in oblong holes • compressor-distractor – connects two screw carriers by means of spherical links, ensuring compressionor distraction of bone fragments. • module with 2 spherical beds – connects two screw holders by means of spherical links • module transferring 90O– used in fixators designed for treatment of supracondilar fractures; • module transferring 135O - used in fixators designed for fractures of the neck of the femoral capitellum

  10. 5 PRINCIPLE OF ACTION OF THE MECHANISMS MECHANISM, FIXING THE SCREWS 1 3 2 4 • Consists of a nut (1), mobile connected with a pressing bush (2), moving linear along the threading stem (3) with cross holes (4) for the screws, finishing with unificated ball-and- socket joint. The screw (5) mounted in the bone is pressed to the bottom of the elongated hole by screwing the nut (1), as the positioned at the very beginning of the hole screw moves linear along the screw holder axis from 2 to 5 mm. 5

  11. PRINCIPLE OF ACTION OF THE MECHANISMS MECHANISM, FIXING THE SCREWS • The simpliness of this decision creates some interesting new possibilities: • Reversing the direction of the bush movement creates conditions for compresson or distraction of the fixing screws in the screw holder . In this way, monofixators for multifragment fractures can be synthesized. • Possibilities for independent assembly of the screws with different diameters /from 3 to 6 mm/ to all levels of the screw holder. Conditions for dosing the elasticity of the fixation at the very beginning of the treatment. • Possibilities for combination of the screw holders /with 2 to 10 holes/ in order to achieve an individual strong frame, allowing screw tightening as near to the fracture line as possible.

  12. 1 2 3 5 4 PRINCIPLE OF ACTION OF THE MECHANISMS UNIFICATED BALL AND SOCKET JOINT • The ball consists of two parts: a solid polished one (4) made of stainless alloy, and a front soft one (3) - of aluminium. After achieving a good fragment reposition, the nut with the spherical interior plane (5) is screwed and presses the ball to the spherical bed (2). A screw (1) with a sharp conic point is screwed for additional interlock of the mechanism. • This link enables the assembly of a wide range of apparatus. The assembled modules can be turned in relation to each other at an angle of 200 in all spatial positions.

  13. PRINCIPLE OF ACTION OF THE MECHANISMS UNIFICATED BALL AND SOCKET JOINT

  14. PRINCIPLE OF ACTION OF THE MECHANISMS COMPRESSION-DISTRACTION MECHANISM • The mechanism comprises a threaded guide (5) ending with an element of the ball-and-socket joint (8) and having a rectilinear groove (6) along the threaded stem. The envelope (3) is screwed on the guide (5), both performing linear movement axially together with the follower (2). The turning of the follower (2) in relation to the guide (5)is blocked by the pellets (7), which move along the grooves (6) of the на guide (5). • The nut (4) is intended to block the follower (2). • This mechanism ensures stable and smooth compression-distraction, combined with reliable blocking in the desired place. 3 4 5 1 2 8 6 7

  15. PRINCIPLE OF ACTION OF THE MECHANISMS COMPRESSION-DISTRACTION MECHANISM

  16. PRINCIPLE OF ACTION OF THE MECHANISMS MECHANISM OF TRANSFERRINGMODULES • The transferring modules have holes for the implant screws, their axes placed at an angle to the sphere axis. The holes are double conic, the bigger diameter turned outside. The screws used for these modules have threading on their stems.The screws are fastened in the holes by means of split conic bushes, screwed on the screw stem. When the bush is tightened , because of its conic shape, its segments are contracted, thus tightening the screw reliably. • This construction allows adjustment of the screw position axially, ensuring precise repositioning of the bone fragments.

  17. PRINCIPLE OF ACTION OF THE MECHANISMS MECHANISM OF TRANSFERRINGMODULES

  18. 1 2 3 SCREW DESIGN • 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.

  19. 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. • Adaptability – the spatial position of modules can easily be changed – axially and around the three axes of rotation. • With this system one can achieve independent reposition of the fragments of the fracture and then fix firmly the attained good position of the fragments. • Universal with respect to the implant screws – on each screw holder screws with different diameters can be mounted - from 3 up to 6 mm. • Performs compression-distraction in two ways: through the compressor-distractor module and through the compression-distraction nuts of the screw holders which turns it into a monofixator for treatment of multiple fractures. • Isolator property achieved by hard anodized coating with Al2O3

  20. SET OF FIXATORS, IMPLANT SCREWS AND INSTRUMENTS IN THE STERILISATION BOX

  21. SET OF FIXATORS, IMPLANT SCREWS AND INSTRUMENTS IN THE STERILISATION BOX

  22. SET OF FIXATORS, IMPLANT SCREWS AND INSTRUMENTS IN THE STERILISATION BOX

  23. EXTERNAL FIXATOR FOR UPPER EXTREMITY 1 • 1 800100 screw holder with 2 holes and 2 nuts • 2 800100-01 screw holder with 3 holes and 2 nuts • 3 800100-02 screw holder with 4 holes and 3 nuts • 4 800100-03 screw holder with 5 holes and 3 nuts • 5 800100-04 screw holder with 6 holes and 4 nuts • 6 800100-05 screw holder with 7 holes and 4 nuts • 7 800100-06 screw holder with 8 holes and 4 nuts • 8 804000 compressor-distractor short • 9 804000-01 compressor-distractor long • 10 800900 module with 2 spherical beds 11 801000 module transferring 90O • 12 801100 module transferring module transferring 135O 2 3 4 5 6 7 8 9 11 10 12

  24. EXTERNAL FIXATOR FOR LOWER EXTREMITY 1 2 • 1 800200 screw holder with 2 holes and 2 nuts • 2 800200-01 screw holder with 3 holes and 2 nuts • 3 800200-02 screw holder with 4 holes and 3 nuts • 4 800200-03 screw holder with 5 holes and 3 nuts • 5 800200-04 screw holder with 6 holes and 4 nuts • 6 800200-05 screw holder with 7 holes and 4 nuts • 7 800200-06 screw holder with 8 holes and 4 nuts • 8 800200-07 screw holder with 9 holes and nuts • 9 800200-08 screw holder with 10 holes and nuts • 10 804000-02 compressor-distractor short • 11 804000-03 compressor-distractor long • 12 800900 module with 2 spherical beds • 13 801000-01 module transferring 90O • 14 801100-01 module transferring 135O 3 4 5 6 7 8 9 10 13 11 12 14

  25. INSTRUMENTS • 900100-05 wrench 12 • 900100-08 wrench 15 • 900100-10 wrench 19 • 900100-11 wrench 22 • 900100-13 wrench 27 • 905100 screw spanner Ø3 • 905100-01 screw spanner Ø4 • 905100-02 screw spanner Ø5 • 905100-03 screw spanner Ø6 • 920100 guide with arm 900100-xx 905100-xx 920100 920100

  26. INSTRUMENTS • 901000 barrel spanner 12 • 902200 screw spanner S 3.5 • 920300 guide for transferring modules • 909200 spanner for trocars and protectors • 922100 protector short Ø3 • 922100-01 protector short Ø4 • 922100-02 protector short Ø5 • 922100-03 protector short Ø6 • 922200 protector long Ø3 • 922200-01 protector long Ø4 • 922200-02 protector long Ø5 • 922200-03 protector long Ø6 • 923000 trocar Ø3 • 923000-01 trocar Ø4 • 923000-02 trocar Ø5 • 923000-03 trocar Ø6 901000 920300 902200 909200 922200-xx 923000-xx 922100-xx

  27. SCREWS cat. № Name 700200-02 screw Ø4 L 080/20 700200-03 screw Ø4 L 090/20 700200-04 screw Ø4 L 100/25 700200-05 screw Ø4 L 110/25 700400-01 screw Ø5 L 090/30 700400-03 screw Ø5 L 100/35 700400-05 screw Ø5 L 110/35 700400-07 screw Ø5 L 120/40 700500-03 screw Ø6 L 100/35 700500-05 screw Ø6 L 110/40 700500-07 screw Ø6 L 120/40 700500-09 screw Ø6 L 130/40 Note: In working with the system it is admissible to use implant screws and spokes of other systems and manufacturers, allowed for clinical use.

  28. CANNULATED SCREWS • cat. № Name • 700600-01 Ø6 mm L 90/30 • 700600-03 Ø6 mm L 100/35 • 700600-05 Ø6 mm L 110/40 • 700600-07 Ø6 mm L 120/40 • 700600-09 Ø6 mm L 130/40 • 700600-11 Ø6 mm L 140/40 • 700600-13 Ø6 mm L 150/45 • 700600-15 Ø6 mm L 160/50 Note: In working with the system it is admissible to use implant screws and spokes of other systems and manufacturers, allowed for clinical use.

  29. SCREWS WITH THREADING AND 2 NUTS • 701000-03 screw Ø6 L 100/35 • 701000-05 screw Ø6 L 110/40 • 701000-07 screw Ø6 L 120/40 • 701000-09 screw Ø6 L 130/40 • 701000-11 screw Ø6 L 140/40 • 701000-13 screw Ø6 L 150/45

  30. APPLICATIONS

  31. APPLICATIONS ANTEBRACHIUM FRACTURES 800100 arm with 2 holes & 2 nuts 2 804000 compressor-distractor short 1 700200-04 screw Ø4 L 100/25 4 800100-01 arm with 3 holes & 3 nuts 2 804000 compressor-distractor short 1 700200-04 screw Ø4 L 100/25 6 800100 arm with 2 holes & 2 nuts 1 800100-02 arm with 4 holes & 4 nuts 1 804000 compressor-distractor short 1 700200-05 screw Ø4 L 110/25 6

  32. APPLICATIONS HUMERUS FRACTURES 800100 arm with 2 holes & 2 nuts 1 800101 arm with 3 holes & 3 nuts 1 804000 compressor-distractor short 1 700400-05 screw Ø5 L 110/35 5 800100-01 arm with 3 holes & 3 nuts 2 804000 compressor-distractor short 1 700400-05 screw Ø5 L 110/35 6 800100 arm with 2 holes& 2 nuts 1 800100-02 arm with 4 holes& 4 nuts 1 804000 compressor-distractor short 1 700400-05 screw Ø5 L 110/35 6

  33. APPLICATIONS HUMERUS FRACTURES 800100 arm with 2 holes & 2 nuts 1 804000 compressor-distractor short 1 801100 module transferring 135 1 700400-07 screw Æ 5 L 120/40 2 701000-11 screw Æ 6 L 140/40 with 2nuts 2 800100-01 arm with 3 holes & 3 nuts 1 804000-01 compressor-distractor long 1 801000 module transferring 90 1 700400-07 screw Æ 5 L 120/40 3 701000-07 screw Æ 6 L 120/40 with 2 nuts 2

  34. APPLICATIONS TIBIA FRACTURES 800200-01 arm with 3 holes & 3 nuts 2 804000-02 compressor-distractor short 1 700500-07 screw Æ 6 L 120/40 6 800200 arm with 2 holes & 2 nuts 1 800200-03 arm with 5 holes & 5 nuts 1 804000-02 compressor-distractor short 1 700500-11 screw Æ 6 L 140/40 7 800200 arm with 2 holes & 2 nuts 1 804000-03 compressor-distractor short 1 801000-01 module transferring 90 1 700500-11 screw Æ 6 L 140/40 4 701000-15 screw Æ 6 L 160/45 with 2 nuts 2

  35. APPLICATIONS FEMUR FRACTURES 800200-01 arm with 3 holes & 3 nuts 1 800200-03 arm with 5 holes & 5 nuts 1 804000-02 compressor-distractor short 1 700500-14 screw Æ 6 L 160/45 8 800200-01 arm with 3 holes & 3 nuts 1 800200-04 arm with 6 holes & 6 nuts 1 804000-02 compressor-distractor short 1 700500-14 screw Æ 6 L 160/45 9 800200-02 arm with 4 holes & 4 nuts 1 800200-03 arm with 5 holes & 5 nuts 1 804000-03 compressor-distractor long 1 700500-14 screw Æ 6 L 160/45 9

  36. APPLICATIONS FEMUR FRACTURES 00200-04 arm with 6 holes & 6 nuts 1 800200-05 arm with 7 holes & 7 nuts 1 804000-02 compressor-distractor short 1 700500-14 screw Æ 6 L 160/45 13 800200-02 arm with 4 holes & 4 nuts 1 804000-03 compressor-distractor long 1 801100-02 module transferring135 1 700500-11 screw Æ 6 L 140/40 4 701000-23 screw Æ 6 L 200/80 with 2 nuts 3 800200-02 arm with 4 holes & 4 nuts 1 804000-03 compressor-distractor long 1 801000-01 module transferring 90 1 700500-11 screw Æ 6 L 140/40 4 701000-19 screw Æ 6 L 180/60 with 2 nuts 2

  37. 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 Implants Fixators Instruments • Under pressure Yes Yes Yes • Termal Yes No Yes • With X rays Yes Yes Yes • With gas Yes Yes Yes • Chemical Yes Yes Yes • 4. Fixators are arranged on a surgical table, in accordance with technology, described in the operation plan. • 5. Treat the patient.

  38. OPERATING MANUAL OPERATING WITH THE SYSTEM FOR EXTERNAL FIXATION • Depending on the location, character and complexity of the fracture, the necessary number of screws are inserted in the bonesso 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 preciseinsertion and protection of the soft tissues from additional damage and traumata. • The screws having been inserted, the bone fragments are assembled and stabilised anatomically through metal modules. Remember that there are all possible modules, necessary for healing fractures with different complexity. The correct choice of these modules for each definite fracture ensures optimal steadiness along the fracture line. • Inserting screws in two or three planes concerning the bone axis enables achieving a maximum steadiness of the bone fragments along the fracture line. • The remnant displacement of the bone fragments after the modules’ assembling could be removed by ball-and- socket joints and thread connections.

  39. OPERATING MANUAL THE END OPERATING MANUAL

  40. 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 Screw diameter [mm] • Phalanges of the hands and feet /metacarpal, 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 4 • Diaphyasis and proximal metadiaphyasis of humerus 4; 5 or 6 • Femur 5 or 6 • Pelvic bones 5 or 6

  41. CLINICAL CASES

  42. Clinical case #1 1 Pl.H. 32 year old Dg. Contusio capitis. Comotio cerebri. Contusio thoracis. Fractura costae V, VI, VII dextra. Fractura cruris cominativa in partis distalis intraarticularis. Necrosis cutis. Traumatic shock.

  43. Clinical case #1 2 Resuscitation for dominating the traumatic shock. Plastic setting. Having in mind the appeared necrosis an external fixator is applied.

  44. Clinical case #1 3 Necrectomy. The skin defect is covered with a free graft in the presence of the fixator.

  45. Clinical case #1 4 Early rehabilitation

  46. Clinical case #2 1 43 -year -old man with pseudoartrosa tibiae & infecta fistulosa until 1988 and fistula for 9 years. In an accident gets a wound in the fistula area. After closing the wound the patient is operated.

  47. Clinical case #2 2 Decorticatio a modo Judet et auto osteoplastia tibiae. Fixatio externa.

  48. Clinical case #2 3

  49. Clinical case #3 1 Infected pseudoarthrosis of humerus after corrupted osteosynthesis, followed by grave paraosal phlegmon. Removed synthesis device - AO plate. Fistulographia and operation. Careful debridement, canal opening, osteoplasty. Bone fixation with Axial Fixator. Redon drainage..

  50. Clinical case #3 2 Primary wounds healing. Early rehabilitation

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