| Instructions for Intermaxillary distraction devices |
The introductions must be read carefully before clinical use |
| >>BRIEF INTRODUCTION |
Intermaxillary distraction devices are elaborately made of well biocompatible and tough pure medical titanium and titanium alloy are applied with our corresponding titanium bone screws. Intermaxillary distraction devices are designed for the distraction osteogenesis and reconstructive surgery in oral and cranio-maxillofacial region. The products are well designed and easy to use, and it can improve or correct the defects or deformity of the jaws. The products have maxillary distraction devices CBS types and mandibular distraction devices CBX types, and distraction length is 6 to 60mm. |
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| >>MATERIAL |
Unalloy titanium，ISO5832-2；Ti6Al4V alloy，ISO5832-3 |
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| >>INDICATIONS |
Distraction Devices are designed for the distraction osteogenesis and reconstructive surgery in oral and cranio-maxillofacial region. The indications are as follows:
hemifacial microsomia, congenital micrognathia, acquired micrognathia, transverse discrepancy of upper and lower jaws, hypoplasia of maxilla, orofacial clefts, dental alveolar defect or atrophy, segmental mandibular defect, Pierre-Robins syndrome, treacher-Collins syndrome, Crouzon syndrome, obstructive sleep apnea syndrome, etc.. |
| >>WARNINGS |
Distraction devices aid the surgeon in the alignment and stabilization of the oral,cranio-maxillofacial skeletal bone for fixation of fractures, osteotomies and reconstructive surgery. While the distraction devices are generally successful in attaining these goals, they should be removed in time. If there is delayed union, nonunion, or incomplete healing of bone, the distraction devices can be expected to fail. So, it is very important that immobilization of the fracture region be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. The size, the shape of bones and the soft tissue place limitation on the size and strength of the distraction devices. Metal surgical implants are subject to repeated stresses in use, which can result in fatigue fracture. Factors such as the patient’s activity level, and adherence to load bearing instructions have an effect on the service life of the implant. So, the surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the distraction devices, but also must be aware of the mechanical and metallurgical aspects of metal surgical implants. |
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1. Unalloy titanium and titanium alloy, the materials of the distraction devices are subject to corrosion. Implanting metals and alloys subjects them to constant changing environments of salts, acids, and alkalis that can cause corrosion. Putting dissimilar metals and alloys in contact with each can accelerate the corrosion process that may enhance fracture of the distraction devices.
2. Correct handing of the distraction devices is very important .The distraction devices should be modified only when necessary. Modifications or excessive contouring of the distraction devices may weaken the distraction devices and lead to breakage. Notches or scratches put on the distraction devices during the course of surgery may lead to breakage.
3. The distraction devices may be taken out after the bone full-grown. The distraction devices can loosen, fracture, corrode, migrate, or cause pain.
4. Intraoperative fracture of titanium bone screws can occur if excessive force (torque) is applied while seating titanium bone screws.
5. Adequately instruct the patient. It is very importance of the postoperative care. The patient’s ability and willingness to follow instruction is one of the most important aspects of successful fracture management. Patients with senility, mental illness, alcoholism, or drug abuse may be at higher risk of the distraction devices failure since these patients may ignore instructions and activity restrictions. The patient is to be instructed in the use of external supports and braces that are intended to immobilize the fracture site and limit load bearing. The patient is to be made aware and warned of general surgical risks, complications, possible adverse effects, and to follow the instructions of the treating physician. The patient is to be advised of the need for regular postoperative follow-up examination as the instructions of the treating physician. The patient is to be advised of the need for regular postoperative follow-up examination as long as the devices remains implanted. |
| >>INSTRUCTION FOR APPLICATION |
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1. The devices should be sterilized under general high pressure and high temperature.
2. Designed and evaluated before operation, including the model of distraction devices, the fixed position of devices, distraction length 、malocclusion、operation manner and the position of osteotomy line.
3. Expose the distraction bone for osteotomy line confirmation during operation.
4. Distraction devices fixation:
（1） Fixed the distraction devices on bone cortex temporarily, and then confirm the distraction direction in accord with operation designed plan.
（2）Remove the distraction devices, and put the osteotomy into practice with saw and drill, and then relocate the distraction. Adjust the distraction devices open 5～10mm length, if the devices works well, then pullback and suture the wound.
5. Start distraction the 5 to 7 days after operation, one turn at a time （1 turn=0.4mm）, and the distraction rate is two times per day or determined by clinicians. While distraction devices are generally successful in attaining clinical goals, the distraction should be stopped.
6. Observed clinically to the patient everyday after operation, and adjust the distraction length according to the patient’s restoration state.
7. Holding the devices three or four months after distraction stopped, confirmed by X –ray or CT films and validate new bone full-grown, and then remove the distraction devices in time.
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