Simple fresh compression fracture of thoracolumbar spine caused by osteoporosis in middle-aged and old people without neurological injury;
Old spinal compression fracture (more than half a year), severe kyphotic deformity and intractable low back pain caused by fracture;
Multistage compression fractures of the upper and lower adjacent vertebrae secondary to osteoporotic compression fractures;
Pathological compression fracture caused by the benign and malignant tumor of the vertebral body.
Recover the vertebra height as much as possible by putting patient in prone position (PP) or pressing the fracture part.
The diameter of the delivery cannula is 2.8mm, which is thinner than the traditional cement filler and more convenient to enter the vertebral body. Meanwhile, the distal end of the delivery cannula is blunt and not easy to puncture the vertebral body.
The delivery cannula can be inserted into the vertebral body with small swing. By doing so, it can lift the upper and lower endplates to recover the height, on the other hand, the direction of the delivery cannula can be adjusted in time to ensure that it is in the vertebral body.
Before extending the curved ballon in the vertebra, it should be inserted to the middle or anterior position of the vertebra, and attention should be paid to the internal pressure of the curved ballon (≤200 Psi) and the volume of contrast medium (≤6 ml) during the process.
In the case of old fracture, there will be problems such as the delivery cannula cannot enter the vertebra by breaking the bone.
Due to the certain elasticity and insufficient rigidity of the delivery cannula, the cannula may be deformed when inserting the hard bone and penetrated to other points of the vertebra, which has certain risks.
Reading the CT scanning carefully before operation, operators can make a plan about the puncture path in advance, and then use a puncture needle to penetrate the bone callus which will offer an available path for the cannula.
Disposable Cavity-opening Device can be used for old fracture solution, the device can be penetrated through the hard tissues and then extended to create a curved channel inside the vertebra, which makes it easier to insert the curved ballon or bone cement filling.
HICREN currently offers Ф2.4mm, Ф3.0mm, Ф3.7mm and Ф4.2mm puncture needles, Ф2.8mm and Ф3.5mm biopsy needles, and 14mm, 18mm, and 22mm corner radius for curved cannulas. Various models can meet different clinical needs.
It is necessary to control the depth and angle of the puncture needle and limit the depth of the curved cannula entering the vertebral body (the curved cannula does not need to be fully inserted into the vertebral body).
The step-by-step dilatation is recommended. Firstly, penetrating the vertebra by small size puncture needles and then extend the channel by dilators. In near future, Hicren spinal robot is also available to assist in positioning and penetration.ilatation can be used, using smaller puncture needles first and then dilating the channel. In the future, it can also be used with spine robot to assist in positioning and puncturing.
Minimal Invasive Surgery, only requires a 0.5cm incision
The curved bone cement cannula is used to inject the bone cement through unilateral puncture channel. At first, the curved cannula will be inserted and reached to the opposite side of the vertebral body, and then the curved cannula is used to inject the bone cement (artificial bone or other filling materials) slowly while withdrawing from the vertebrae, resulting in a better bone cement filling and dispersion at different points of the vertebrae. The puncture risk is low and the surgical procedure is simple.
Multi-point, low-pressure, directional injection of bone cement (artificial bone or other filling material)
Bone cement (artificial bone or other filling materials) can be injected at any point in the internal channel of the vertebral body, from point to surface, with low pressure injection at different points. At the same time, the direction of bone cement (artificial bone or other filling materials) injection from the curved cannula is effectively controlled, thus the risk of bone cement leakage is low.
The evenly distributed bone cement can provide biomechanical support for the entire vertebral body, effectively relieve pain, and avoid the re-collapse or fracture of the vertebral body in long term.
Vertebral body revision surgery can be performed by curved system.
Curved vertebroplasty and curved kyphoplasty are operated in unilateral puncture, the pedicle on the other side is intact. When the vertebral body is diseased again, the pedicle on the other side can be used for a second operation.
Reduced radiation for patients and doctors
Curved vertebroplasty and curved kyphoplasty are operated in the unilateral puncture, requiring only one surgery per vertebral body. The overall surgical exposure to radiation is minimal, resulting in minimal harm to patients and doctors.
Short learning curve, easy to promote and popularize
Curved vertebroplasty and curved kyphoplasty are easy to operate and have low technical requirements, which are conducive to being carried out in grassroots hospitals and benefiting a wider range of patients.
Traditional balloons require the use of double balloons to be simultaneously inflated on both sides in order to achieve a reduction effect. If a single balloon was inflated twice, it will cause a "seesaw" effect which cannot recover the vertebral height.
The curved balloon only needs one expansion to achieve full vertebral height recovery and correct kyphosis deformity.
Curved balloon is a truly heterotypic balloon with a large contact area, balanced pressure, and more perfect reduction.
After using a curved balloon to expend, the bone cement is distributed in an arc shape within the vertebral body, which has better mechanical stability, reduces puncture risk, and reduces the incidence of re-fractures.
Method 1: Adjust the puncture needle. Checking the previous position of the puncture needle and the damage situation of the vertebral body, the new puncture should be reduced or increased the abduction angle of the needle, advancing or retreating the puncture needle can both avoid the previous channel;
Method 2: Penetrating the curved canula 0.5-1cm deeper than the previous channel, to widen the channel by inserting and adjusting the cannula repeatedly, and then insert the curved cannula into the target area by aiming correctly.
Considering that the bone cement is relatively thin in the early stage, it will diffuse towards the puncture side while injecting on the opposite side. Therefore, during the surgery, the volume of bone cement at different injection points can be decreased successively. Making an example of a single vertebral body perfusion of 6ml bone cement, it can be calculated like that -3ml injected on the opposite side, 2ml at the center point, and 1ml on the puncture side. By this way, when observed from an AP view, the distribution of bone cement on the left, middle, and right sides is more balanced
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