Kyphoplasty Balloon Catheter 11G Version KB0115S1

The highly specialized Kyphoplasty balloon catheter catheter is an essential tool in the sophisticated medical procedure called Percutaneous Kyphoplasty. This innovative device is mainly used to treat severe vertebral compression fractures by stabilizing the spine and dramatically reducing pain, thereby greatly improving patient mobility and overall quality of life. It is also employed in emergency rooms to provide immediate relief for patients with acute spinal injuries, ensuring rapid stabilization and pain management.

1. Characteristics:
· Kyphoplasty balloon catheter is designed for correcting compression fractures and restoring vertebral body height. Doctors should choose the appropriate balloon for dilation according to fracture types;
· Different OD of the sheath can be applied to the different working channels to realize accurate dilation. Different shapes of the balloon can adapt to different thoracic vertebrae, lumbar vertebrae as well as other types of fractures;     
·The balloon materials feature excellent characteristics, such as fine supportiveness, biocompatibility, biological persistence, surface anti-biodegradation, and environmental stress cracking resistance;
· The standard four-wing pleating process ensures excellent passability after repeated inflation;   
· Each balloon has passed the pressure and seal test before leaving the factory. Strict quality control measures minimize the risk of balloon bursts and leakage.

2. Specifications:

Note: 13G and 15G version Kyphoplasty Balloon Catheters are both available, OEM and ODM can also make. 
3. What is kyphoplasty:     
          A compression fracture or a break in one of your vertebra can be painful. It can also make it difficult to move freely. That’s because a break can result in bone fragments rubbing against each other.

     Surgery can help treat such fractures. For example, kyphoplasty and vertebroplasty are minimally invasive procedures that are often performed together. Usually, they can be done without a hospital stay. In vertebroplasty, a doctor injects a cement mixture into the bone to give it strength.

     Kyphoplasty makes room for the mixture. In this procedure, a doctor inserts and inflates a balloon to create an opening for the mixture. The balloon is removed after the cement is injected. Kyphoplasty is sometimes referred to as balloon vertebroplasty.

     Both of these procedures are more likely to be successful if done within two months of a fracture diagnosis. They can help relieve pain and improve mobility when other measures fail to provide relief.

4. What happens before and during the procedures:

4.1 Preparation:  
     Because kyphoplasty and vertebroplasty are surgical procedures, your doctor will probably order some blood tests before the day of your surgery. Imaging tests such as an X-ray or MRI scan will help your surgeon see the area or areas that need repair.
     In preparation, an intravenous line (IV) will be placed in a vein in your arm to deliver anesthesia. You may also receive pain and anti-nausea medications, as well as antibiotics to prevent infection. You’ll probably also be connected to heart, pulse, and blood pressure monitors.

4.2 Procedures: 
    For these procedures, you need to lie down on your stomach. The area in which the needle will be inserted is shaved if necessary and then cleaned and sterilized. A local anesthetic may be injected in the same place.
     Your surgeon then performs these steps:
    1. The surgeon inserts a hollow needle (trocar) into your skin. With the aid of fluoroscopy, a type of X-ray, they guide the needle through your muscles and into the correct position in your bone.
     2. They next insert an inflatable balloon into the trocar.
     3. The balloon is then inflated to create the space needed for the bone cement.
    4. Once the space has opened up, the mixture is injected to fill it up. Imaging tests will help the surgeon confirm that the mixture is distributed properly.
     5. Once the cement is in place, the needle is removed.
     6. The area is bandaged. Stitches won’t be necessary.
     7. Your IV and monitoring equipment are removed.
     If only one vertebra is being treated, kyphoplasty usually takes less than an hour.