O rto T ech D esign Ltd.

1. Orto Tech Design Ltd. RIGID MONOFIXATOR MODEL ‘RAPID’

2. TITLE PAGE OF THE PATENT

3. 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.

4. 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

5. 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 .

6. 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.

7. 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);

8. APPLICATIONS PHALANGES FRACTURES

9. APPLICATIONS PHALANGES FRACTURES

10. APPLICATIONS JAWS FRACTURES

11. APPLICATIONS ANTEBRACHIUM AND HUMERUS FRACTURES

12. APPLICATIONS TIBIA AND FEMUR FRACTURES

13. 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.

14. 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 preciseinsertion 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.

15. OPERATING MANUAL OPERATING WITH THE SET ‘RIGID MONOFIXATOR’ screwing a screw strunging a fixator tightening

16. 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

17. CONTENT

18. MODULES SET FOR UPPER EXTREMITY • cat. № Name • 803000 Module with 9 holes • 803000-01 Module with 11 holes • 803000-02 Module with 13 holes • 803000-03 Module with 15 holes • 803000-04 Module with 17 holes • 803000-05 Module with 19 holes

19. MODULES SET FOR LOWER EXTREMITY • cat. № Name • 803100 Module with 9 holes • 803100-01 Module with 11 holes • 803100-02 Module with 13 holes • 803100-03 Module with 15 holes • 803100-04 Module with 17 holes • 803100-05 Module with 19 holes • 803100-06 Module with 21 holes

20. MODULES SET OF MINIFIXATORS • cat. № Name • 803200 Module with 4 holes • 803200-01 Module with 5 holes • 803200-02 Module with 6 holes • 803200-03 Module with 7 holes • 803200-04 Module with 8 holes • 803200-05 Module with 9 holes • 803200-06 Module with 10 holes

21. SCREWS • cat. № Name • 700200-02 Ø 4 mm L 80/20 • 700200-03 Ø4 mm L 90/20 • 700200-04 Ø4 mm L 100/25 • 700200-05 Ø4 mm L 110/25 • 700400-01 Ø5 mm L 90/30 • 700400-03 Ø5 mm L 100/35 • 700400-05 Ø4 mm L 110/35 • 700400-07 Ø5 mm L 120/40 • 700400-09 Ø5 mm L 130/45 • 700500-01 Ø6 mm L 90/30 • 700500-03 Ø6 mm L 100/35 • 700500-15 Ø6 mm L 110/40 • 700500-07 Ø6 mm L 120/40 • 700500-09 Ø6 mm L 130/40 • 700500-11 Ø6 mm L 140/40 • 700500-13 Ø6 mm L 150/45 • 700500-15 Ø6 mm L 160/50

22. CANNULATEDSCREWS • 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

23. KIRSHNER WIRE WITH ROUND END • cat. № Name • 790100 Ø1.5 mm L 70 • 790100-01 Ø2.0 mm L 70 • 790100-02 Ø2.2 mm L 70 • 790100-03 Ø2.2 mm L 70

24. INSTRUMENTS

25. INSTRUMENTS • cat. № Name qty. • 900100-01 Wrench 8 1 • 900100-08 Wrench 15 1 • 900100-09 Wrench 17 1 • 900300 Blocking bar 1 • 905100-01 Screw wrench Ø 4 1 • 905100-02 Screw wrench Ø 5 1 • 905100-03 Screw wrench Ø 6 1 • 909200 Wrench for trocars and protectors 1 • 901400 Guide 1 • 901500 Guide for Kirshner wires 1 • 922100-01 Protector short Ø 4 4 • 922100-02 Protector short Ø 5 4 • 922100-03 Protector short Ø 6 4 • 923000-01 Trocar Ø 4 4 • 923000-02 Trocar Ø 5 4 • 923000-03 Trocar Ø 6 4

26. CLINICAL CASES

27. 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.

28. CLINICAL CASE #1

29. 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.

30. CLINICAL CASE #1 Five months later roentgenography shows graft reconstruction. Bone defect recovery. Removed external fixator. Full rehabilitation. Excellent results.

31. CLINICAL CASE #1

32. 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.

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41. Contacts • Orto Tech Design Ltd. • Bulgaria 9300 Dobrich, Slavyanska 10 • Tel./Fax +359 59 620120 • E-mail: ortoteh@abv.bg • Dr. Stanislav Nestorov MD • GSM +359 897 969161