Lung Plug System Prevents Postbiopsy Pneumothorax

The system is composed of a syringe, prefilled with a hydrogel that has been solidified and then dried, that is attached to a stylet. After the biopsy sample is removed, the physician attaches the system to the needle used to access the biopsy site and injects the hydrogel through the stylet into the empty space left by the removed lung tissue.

The dried hydrogel rehydrates and expands on contact with body fluids to fill the space, creating a seal that prevents air from leaking out of the lung. The hydrogel is absorbed into the body after healing of the puncture site has occurred. Each Bio-Seal system features two sets of plugs and coaxial adaptors to accommodate multiple lung biopsy sites. The Bio-Seal Lung Biopsy Tract Plug system is a product of Angiotech (Vancouver, Canada), and is available in a broad range of 19G introducers, which may be used in conjunction with any 20G or 22G biopsy device.

“This is an innovative new use for an existing device that can help make percutaneous transthoracic needle lung biopsies safer,” said Christy Foreman, director of the office of device evaluation at the US Food and drug Administration (FDA) Center for Devices and Radiological Health.

The system reduces the risk of a patient experiencing a pneumothorax during a percutaneous transthoracic needle lung biopsy, occurring when air from the lung leaks into the chest cavity, thus preventing the lungs from expanding properly. The condition can cause chest pain, shortness of breath, and cardiovascular distress, and is particularly dangerous in patients who have lung disease.

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