What are CSF Leaks?

The brain and spinal cord are surrounded by a clear fluid called cerebral spinal fluid (CSF). This fluid is under some pressure, which is higher at the base of the spine than it is on the top of the head, due to a water column effect. Enclosing the brain, spinal cord and CSF is a tough, fibrous membrane called the dura mater. At the end of surgery, the dura is sutured closed, in an attempt to make it watertight and to prevent CSF from leaking. The leakage of CSF can create a potential pathway for infection to get inside the brain and spinal cord.

Surgeons often attempt to obtain a “water tight” closure when suturing the dura, but the dura may dry out during surgery and shrink, so that small gaps remain when it is sutured closed. Also, needle holes produced during suturing can leave small holes that may also leak. Despite meticulous attempts to close the dura, many patients experience symptoms resulting from CSF leakage after the surgery. These symptoms can include delayed healing of surrounding tissues since CSF is caustic to bone, muscle and skin. Collections of CSF under the skin can cause compression of nerves and breakdown of the wound closure. Low CSF levels can lead to severe headaches, which are aggravated by sitting or standing up. CSF leaks can also create a pathway to track bacteria and create life-threatening complications, such as meningitis.

DuraSeal Dural Sealant has been developed to assist the surgeon in obtaining a real watertight closure. Following normal dura suturing, the surgeon can spray the sealant onto the incision, effectively sealing all the needle holes and other small gaps. The sealant then will stay in place, sealing the incision while the incision heals naturally underneath. Once dura healing is complete, DuraSeal then gets softer, eventually becoming a liquid that is naturally absorbed by the body.




DuraSeal is not approved for sale in the United States.
DuraSeal is currently under clinical investigations in the U.S.
 






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