| Purpose 1.To develop a set of bending angle of balloon kyphoplasty with bone cement injection device; 2.To prepare osteoporotic vertebral compression fracture model through the pig vertebral decalcification and screening of osteoporotic vertebral body by bone mineral density measurement.3. The bending angle of balloon kyphoplasty with bone cement injection device used in animal experiment. To study the feasibility of safe, effective, rapid recovery of vertebral biomechanics by unilateral pedicle puncture complete bilateral vertebral augmentation with bone cement.Methods The first part:Measuring the human body CT imaging of the thoracic lumbar vertebral transverse diameter and longitudinal, calculate the average value, the vertebral body based on the assumption of ideal oval module. According to the calculation of the oval area and thoracolumbar inclined angle, the bending angle of the front arc length and angle, using titanium memory alloy spring, by means of heat treatment made the bending angle device.The second part:1. Select 30 porcine thoracolumbar vertebral bodies (T10-L3).Remove of rib bone, ligament, muscle, retain partial transverse process, placed the vertebral bodies in 10% formalin fixed within 24 h. The 3-5mm bit is used by both sides of pedicle drill holes at the fixed after completion until the drill into the vertebral body anterior vertebral 1cm distance. Put the prepared vertebrals into EDTA-Na2 solution, EDTA-Na2 solution was replaced once a day using a syringe irrigation 10min in bilateral pedicle drilling. It took 14 days for the preparation of osteoporosis model.2. We select 3 alternative specimens by HOLOGI (T11-L5) American osteoporosis type specimens from the dual energy X-ray bone density instrument test vertebral bone mineral density.3. Remove the upper and lower articular process of vertebral specimens so that vertebral level does not have the prominent anatomical structure ensuring the level of vertebral body stress test. INSTRON3382 biomechanical machine used in this test American produced by Instron Co will be placed in between the experimental vertebral mechanical machine, mechanical force and pressure plate, lmm/min loading rate of vertical compression experiment until the specimens collapse or stop loading compression fractures.The third part:1. Select 13 male Landrace pigs which are weighing about 50kg.Pigs were divided into two groups observing the subjects characters at the postoperative 1 week,1 month,3 months,6 months. The experimental group operation mode to create vertebral bone defect was implanted in the corner balloon, the control group were injected directly into the PMMA bone cement.2.Pigs demineralized osteoporotic vertebral compression fractures (T10-L3) in 20 specimens were randomly divided into two groups:experimental group and control group each 10 vertebral body. The experimental group of pedicle screw holes into the corner balloon bone cement injection system, measuring the amount of bone cement injection and the height of vertebral body. The control group of the pedicle perforation with bone cement injection gun into the PMMA bone cement, bone cement injection volume measurement and height of vertebral body.3.cadaveric osteoporotic vertebral compression fractures (T11-L5) in 15 specimens were randomly divided into two groups:the experimental group of 8 vertebral pedicle screw placement, punch out corner balloon bone cement injection system, measuring the amount of bone cement injection and the height of vertebral body. The control group of 7 vertebrae, pedicle drilling with bone cement injection gun PMMA bone cement was injected capsule, measuring the amount of bone cement injection and the height of vertebral body.Results:The first part:We have successfully developed a set of bending angle of balloon kyphoplasty with bone cement injection device using metal memory titanium alloy. The second part:The pig vertebral specimens were made into models of osteoporosis. Both pigs’and body’s vertebral body were successfully pressed into osteoporotic vertebral compression fractures model.The third part:the bending angle of balloon kyphoplasty bone cement was injected into the unilateral implantation device can complete bilateral injection effect, effectively restore vertebral height, reduce the rate of bone cement leakage, safe, efficient, cheap.ConclusionrA set of bending angle of balloon kyphoplasty with bone cement injection device is successfully developed. Bending angle of balloon kyphoplasty bone cement injection device could complete a whole bone cement vertebral body enhancement by unilateral pedicle in fracture model of osteoporotic vertebral bodies in pigs and body.In animal experimental pigs were determined on the corner of balloon kyphoplasty with bone cement injection device with less complications, higher security, more convenient and it has a promising clinical prospect. |
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