Internal Fixation Titanium Plates and Screws

Operation Manual

FOREWORD

Bio-mechanically speaking, the operation of internal fixation of jaw bone fracture is complicated (especially of mandibular fractures), but technically it is a simple process. Medical workers after extensive research summed up some principles and rules for internal fixation of jaw bone operation from the biological mechanics. The internal fixation Titanium plates and screws of Ningbo Cibei Medical Treatment Appliance Co.,Ltd. are used in the clinical treatment process at major hospitals, and many surgery successful experiences are summed up. Through mastered these basic theoretical knowledge, and complained with the practice strictly, combined with the study, a fracture internal fixation system was established and also the maxillofacial surgery operation was standardized from the perspective of mechanics and biology. The internal fixation Titanium plates specially designed for facial fractures (especially of mandible) which often bearing all kinds of the pressure stress, and drag stress and twisting force.

The internal fixation Titanium plates have five categories:

1) Maxilla internal fixation Titanium plates;

2) Orthognathic internal fixation Titanium plates;

3) Mandibular internal fixation Titanium plates;

4) Internal fixation Titanium plates for reconstruction;

5) 3-dimention mesh Titanium plates for reconstruction of cranial or facial.

The internal fixation Titanium plates are made of pure titanium materials accord with the GB/T 13810-97 standard, and the internal fixation titanium screws are made of titanium alloys which accord with the GB/T13810-97 standard the same. These guarantee the targets needs of internal fixation operation in the mechanical and biological properties. According to the clinical needs, wrenching and bending lever can be used to bent internal fixation plate into a doable shape, the internal fixation titanium screws in angle aspect designed allows for 30°.

We also support the clinical medical staff with special matching tools like wrenching and bending lever、 screwdrivers and drillings for implanting or removing the screws .

Operating Technique of Internal Fixation Titanium Plates and Screws:

1, The operation should be confirmed by the medical staff firstly and they must make a clinical scheme before the operation.

2, Based on patient’s X--film, the type and quantity of the internal fixation titanium plates should be checked, and then equipped with the appropriate tools and surgical equipment. If the packaging of the plates or screws was damaged, the plates or screws must be sterilized prior to surgical use.

3,Selected different specifications of drillings on the basis of internal fixation titanium screws.

4, Based on the clinical scheme, anesthesia will be given differently. The general use is the entire nasal full-anesthesia; sometimes partial anesthesia way is also used; dissection the wound cuticle muscle and restoration, identification of fixed screw point for drilling operations; while drilling project must maintain the same line.

Note: Drilling Attention:

1), The jaw bone cortex with an average thickness of 3mm, titanium screw fixed within the 3-4 screw threads will be provided adequate power.

2), The quality of drilling decided to the success of fixation and it should be careful and precise. Although drilling is not necessary plumb to the surface of the plates (30° within the angle is allowed), but drilling process must be maintained with a strict line of in and out.

3), Any change direction in drilling process inevitably bring a coniform space, which reduce the amount of the screw threads in the bone, because the oval or coniform space usually provide the space for only one screw thread fixed. Within the whole process it should be continuous liquid cooling to prevent bone necrosis due to heat.

4), When dig down 3mm~4mm in a health bone, it will be a feeling of hollow that indicates it enters to cartilage .and then stops drilling. Drilling must be particularly careful to avoid injuring the nerve or fang.

5, strength of the drilling must be moderate so as to avoid creating micro-fracture around the screw. Each side of fracture parts should be fixed at least two screws.

6, using the self—tapping screws, there would be no need for drilling. The screws can be drilled in directly from the determined point. It should be use the 3-dimension mesh to the cerebral fractures in order to avoid damaging the brain cells.

7, using the wrenching and bending lever to shape the internal titanium plates exactly has significant impact on the success of operation. Once one or more of titanium screws were fixed and do not further change the shape, but put it down and re-shaped. In the course of shaping, the plate should not be crankled for fear reducing the intensity of the plate.

8, The mandibular fixation should be operated as careful as possible to against injury fang.

Note: because chewing has pulled muscle to bring a pressure stress on basic bone. Pulling stress is a negative factor, causing the separation of upper of the fractural parts.

9, Two pieces of internal fixation plates are needed to fix the mandibular fracture, which 2~5mm should be remained between those two pieces of plates.

Note: because chewing have pulled muscle to bring a pressure stress, which brings a turning stress between the fangs of the former part of mandibular. That will cause the separation of the fractural parts, and not easy to heal.

10, The order of implanting the plates and screws followed by the general procedure: from the fracture line to the two sides one by one in turn. While fixing the screw, make sure to pay more attention to prevent the screw becoming flexible.

11, At the end of operation, each titanium screws should be checked tight or not, and check-up occluding of the fracture wounds and wash with physiological saline water.

12, Suturing the skin and closing the wounds carefully, and enswathing the wound parts in a partial pressurized way.

13, At the end of the first day, the review procedure should be in X- filmed, and use antibiotics after three days

14, Fixed three months after fracture healing, the internal fixation titanium plates and screws became an functionless implants, regarded as foreign matter. Although so far there is no evidence indicates that the plates or screws can cause any harm and our understanding to them is incomplete, it is not sure that people living with these asymptomatic matters in the body for a long-term is harmless. As long as out of the titanium plates and titanium screws is not to cause too much suffering, It should be removed, especially for the children, just to prevent the plates and screws having an effect on children’s development, After fractures healing, products removed from the patients body should be destroyed and avoid being used again.

Operating Technique of Lag Internal Fixation Titanium Screw

1. Lag internal fixation titanium screws substitute the normal internal fixation plates and screws, because it has a function of fixation to mandibular fracture and small traumatic surface and simple operation process.

2, The operation should be confirmed by the medical staff at first and then make a wonderful clinical scheme.

3, Based on patients’ X--film, The type of the lag internal fixation titanium screws should be checked, the normal tools and surgical equipment should be prepared before the operation. If the packaging of the screws was damaged, the screws must be sterilized prior to surgical use.

4, Selected specifications drillings according to the lag internal fixation titanium screws.

5, Based on the clinical scheme, anesthesia will be given differently. The general use is the entire nasal cavity full-anesthesia; sometimes partial anesthesia way is also used; dissection the wound cuticle muscle and restoration, identification of fixed screw point for drilling operations; while drilling project must maintain the same line.

6, Measurement the depth of the screws drilled in.

7, Change the reamer -drillings.

8, Choose a suitable length of the titanium screws, and place pressurized washer, and then implant the screws carefully with professional screwdriver, make sure the tightness of the screws.

9, Two pieces of these screws should be implanted for a longer line of fracture in the same methods.

10, Occluding the fracture wounds and wash with physiological saline water.

11, At the end of the first day, re-X- filmed and use antibiotics before and after the operation for three times.

12, Fixed three months after fracture healing, the lag internal fixation titanium screws became an functionless implants, regarded as foreign matter. Although so far there is no evidence indicates that the screws can cause any harm and our understanding to them is incomplete, it is not sure that people living with these asymptomatic matters in the body for a long-term is harmless. As long as out of the titanium screws is not to cause too much suffering, It should be removed, especially for the children, just to prevent the screws having an effect on children’s development, After healing fractures, products removed from the patients body should be destroyed and avoid being used again.

Operating Technique of Intermaxillary Traction (IMT) Titanium Screw

Internal Maxillary Traction (IMT) Titanium Screw is one of the latest methods of oral intermaxillary fixation, it stands for the normal tool to minimize the harm and reduce traumatic surface. After using the internal maxillary titanium screws, the time of recover is short, and the closing restoration is accurate. We can increase the number of the screws for a serious fracture; thereby increase the power of traction and the stability of intermaxillary. If the titanium plates added more, the operation can get a functional restoration and fixation. Reserving the intermaxillary screws in the patient’s body after operation and observing the occluding in patient clear-headed state. In the case of chewing unsatisfactory, you can get a fine-tuning, which significantly reduced the patient’s preparation time before and after the operation.

1, The operation should be confirmed by the medical staff at first and then make a wonderful clinical scheme.

2, the type of the intermaxillary screws should be checked and the normal tools and surgical equipments should be prepared before operation. If the packaging of the screws was damaged, the screws must be sterilized prior to surgical use.

3, If it is a self-drilling and tapping screws, implant the screws directly without drilling; If it is an ordinary type, choosing a φ1.6 drilling at first and then make the titanium screws fixed.

4, Based on the clinical scheme, give the patient full- anesthesia

5. Implanting directly 10 pieces of screws (Type:CBMA2.0-9-106)according to the sketch-map as follows :

1 1 , 34 43 , 34 43 65 56 65 56

6, If the fracture parts without conglutinating, first to restore the parts inosculating, and fix the upper and lower traction screws with steel wire,

7, If the fracture surfaces conglutinated not exactly, dissect and restore the wound again and then enlace the parts fixed.

8, Enclosed wound, remove the steel wire and reserve the screws, Enlace the wound after two days and maintain two weeks removed.

9, Implant the screws vertically in operation to avoid the screws loosing, if ordinary type it is, drilling constantly dripping down and slower rotational speed, try to operate the process smoothly.

Operating Technique of Self-Drilling Micro-screws Anchorage (SDMA)

Self-Drilling Micro-screws Anchorage (SDMA) makes an important role in the course of treatment for implant anchorage in orthodontics, it is self-drilling and self-tapping without prior to drill, and also it can afford a stress. With the following advantages:

l Simple performance for insert and removal;

l Minimal trauma and discomfort, easily acceptable by the patients;

l Low risk and low cost;

l Higher successful rate;

l Superior to borderline cases.

1, The Self-Drilling Micro-screws Anchorage (SDMA) should be confirmed by the medical staff firstly and they must make a clinical scheme before the operation.

2, The type of Self-Drilling Micro-screws Anchorage (SDMA) should be checked and the normal tools and surgical equipments should be prepared before operation. If the packaging of the SDMA was damaged, the SDMA must be sterilized prior to use.

3, Based on the clinical scheme, give the patient partial- anesthesia and implant the screws directly and carefully.

4, When clinical target arrived, the SDMA is removed out directly in condition of the partial-anesthesia and without secondly operation.

Possible Adverse Reactions:

1, The fracture bones do not heal or delay to heal, which can lead to the implants break.

2, The density of the bones will decline because of the stress shielding.

3, Especially in winter, patients sometimes feel pain in the fixed district, or feeling unusual, even sometimes the operation makes the surrounding muscle and skin shrinking or leads scar organizations.

4, The bone may not heal or delay healing because of the implants unfastened, bending, cracks or break.

5, Necrosis

6. The internal fixation plates sometimes can be seen after the mandibular implanting operation.

7, Forward infection exists around the implants or in the bone.

The early prosthetics is necessary in any of the above side effects after operation.

Recommendations on Removing Internal Fixation Titanium Plates and Screws

Within fixed 6~8 weeks, fractures will be heal, then these plates and screws will became redundant, how to deal with these plates and screws is still in controversy. At present, maybe there isn’t have an absolute biological inert material suited to make the implant matters. Although pure titanium and titanium alloys is the best choice, it is not clear that whether bring side-effects that remain these matters in the body for decades or not. Animal experiments confirm: titanium implanted in the area of regional lymph node still detected titanium- ions exist.