English
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TOOLMED
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1 Pcs
5-7 days
Product Description
The high-strength balloon material and precise inflation capabilities allow for the controlled elevation of the collapsed vertebral endplates, directly addressing the painful kyphotic deformity associated with VCFs.
The expanded balloon creates a distinct, compacted void within the cancellous bone. This critical step ensures that the subsequent bone cement injection fills a contained space rather than uncontrolled extravasation, thus minimizing cement leakage risk.
Offering multiple sizes ensures the system can be adapted to the varied anatomy of the thoracic, lumbar, and sacral spine, optimizing the filling of different vertebral bodies for maximum structural support.
The balloon catheter tip incorporates radiopaque markers and is used with contrast media (via the inflation device), providing excellent visibility under fluoroscopy for accurate placement and monitoring of expansion within the vertebra.
Primary indication is for acute and subacute VCFs caused by severe osteoporosis, where the goal is pain reduction and stabilization.
Used to stabilize certain traumatic compression fractures where posterior column stability is maintained and height restoration is desired.
Indicated for VCFs resulting from metastatic tumors or multiple myeloma, to relieve pain and restore structural integrity before or after radiation therapy.
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The Kyphoplasty Balloon 10/15/20 is a specialized, disposable balloon catheter used in the minimally invasive surgical procedure called Kyphoplasty. Its role is twofold: first, to gently push the compressed bone fragments of a fractured vertebra back towards their original position to restore height, and second, to create a hollow cavity inside the vertebral body. This cavity is essential because it receives the bone cement (PMMA), ensuring the cement remains contained and provides internal structural support.
The primary application is the treatment of painful vertebral compression fractures (VCFs), particularly those resulting from advanced osteoporosis. It is also used in cases where VCFs result from benign tumors or localized metastatic disease in the spine. The range of sizes (10/15/20) allows the surgeon to treat fractures at different spinal levels, from the mid-thoracic region down to the lower lumbar spine, where vertebral bodies are larger.
The use of the balloon is the defining advantage of Kyphoplasty over the older procedure, Vertebroplasty. By expanding the balloon, the surgeon can achieve vertebral height restoration and create a low-pressure void. This mechanical tamping effect significantly reduces the risk of the liquid bone cement leaking out of the fracture site into the spinal canal or nearby veins, which is a major complication of Vertebroplasty.
Biomechanically, the balloon acts as an internal, hydraulic jack. When inflated, it concentrates pressure precisely on the inner compressed cancellous bone, forcing the fractured endplates apart. This action corrects the localized spinal curvature (kyphosis) and stiffens the bone structure. When the cement fills the newly created void, it solidifies into an internal cast that provides immediate, durable, and axial load-bearing stability.
The procedure is typically performed under fluoroscopic guidance. A working cannula is placed into the fractured vertebra, often bilaterally. The collapsed balloon is inserted through the cannula, and then slowly inflated using a high-pressure inflation device and contrast media, watching carefully for height restoration. Once the cavity is adequate, the balloon is rapidly deflated and withdrawn, and the void is filled with PMMA bone cement.
Since Kyphoplasty is a minimally invasive, percutaneous procedure, patients typically experience immediate and significant pain relief. They usually require only a brief hospital stay and can quickly return to ambulation and non-strenuous daily activities, often within a day of the procedure, thanks to the immediate stabilization provided by the cement.
The Kyphoplasty Balloon 10/15/20 is a state-of-the-art component manufactured by TOOLMED, enabling surgeons to effectively treat painful vertebral compression fractures. Its design allows for controlled height restoration and safe cement delivery, making it the preferred choice for restoring spinal integrity and providing rapid, reliable pain relief to patients suffering from VCFs.
These numbers typically refer to the various maximum sizes of the balloons available in the system, often representing the final expanded diameter or the maximum size of the cavity created, used to fit different sizes of vertebral bodies.
No, the balloon catheter is always removed once the cavity has been created and vertebral height has been restored. Only the bone cement (PMMA) remains behind to provide permanent support.
While the balloon's primary mechanical action is to restore height and reduce the kyphotic angle caused by the fracture, it is most effective for acute, less severe VCFs. Chronic or severe deformities may require more extensive surgical intervention.
A non-compliant balloon material means that its shape and volume remain consistent once the target pressure is reached, ensuring a predictable and controlled cavity is created within the vertebral body, regardless of variations in bone density.
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