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The Retrieval Balloon is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon. The device is for adult use only.

The proposed device Single use stone retrieval balloons includes Stone Retrieval Balloon, inflation pump and two-way valve. Stone Retrieval Balloon is commonly used in traditional ERCP surgery with a long guidewire.

The proposed Single use stone retrieval balloons is comprised of a natural latex balloon mounted at the distal end of a Pebax catheter with three internal lumens for ballooning, guidewire and contrast medium. The internal lumen for ballooning is used to inflate/deflate the balloon. Multiple syringes are included with the packaging, allowing balloon inflation to a specific diameter.

Following insufflation, the balloon surface lies flat against the bile duct wall, enabling efficient and complete cleaning of the bile duct. A separate lumen is designed for a 0.035 inch guidewire. Another separate lumen is designed for contrast agent.

The balloon can be inflated to 8.5 mm, 12 mm, 15 mm and 18 mm diameters using the inflation pump and be kept in an inflated state by two-way valve. Balloon can be inflated to two or three distinct sizes if a different diameter is needed without having to exchange devices. During stone removal process, the balloon can be filled to removal multiple stones in the biliary tract.

There are two developing rings placed at the distal and proximal ends of the balloon providing high fluoroscopic visualization of the balloon location.

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