Sealing Liver Biopsy Tracts with Hydrogels

DESCRIPTION (provided by applicant): Many experts consider the liver biopsy to be the most specific diagnostic tool used to assess the nature and severity of liver disease. There are many important reasons for performing liver biopsies, such as accurate diagnosing or ruling out any coexisting liver disease, staging and grading the severity of HCV disease, treatment decisions, patient and provider reassurance, and as a benchmark to gauge or measure future disease progression. Furthermore, diagnosis of hemochromatosis, occult hepatitis B and non-alcoholic steatosis can only be made by a liver biopsy and can have an important impact on the treatment and prognosis of hepatitis C. The most common type of liver biopsy is a percutaneous (through the skin) needle biopsy. Ultrasonography or Computed Tomography (CT) scans may be used to aid in the procedure to identify lesions in the liver and pinpoint the exact point in which the needle will be inserted. Approximately 30% of people biopsied experience mild and moderate pain during and after the procedure. Complications for the procedure are another area of concern, but are generally uncommon. It is estimated that 3 biopsies per 1,000 have complications and 3 per 10,000 result in death. Also, there is an immeasurable but substantial population that need a liver biopsy performed, but cannot because of high risk of hemorrhaging. The risk of post-biopsy hemorrhagic complications is particularly great in patients with coagulopathy or therapeutic anticoagulation, such as patients undergoing dialysis, those with hepatic failures or those with transplants. The severe bleeding complications are related to the puncture of the liver capsule during biopsy, thereby allowing blood to escape into the peritoneal space, which can result in life threatening bleeding and even death. The deployment of a dehydrated hydrogel plug (Bio-Seal) into the biopsy tract across the liver capsule which expands in vivo rapidly to mechanically seal the biopsy tract may benefit all patients that need and have been denied a liver biopsy. This Phase I proposal will explore the feasibility of using Bio-Seal biopsy tract sealant as an effective plug following a liver biopsy in the porcine model (for both acute and chronic studies). The long-term objectives are to obtain FDA clearance and commercially sell the Bio-Seal system to seal biopsy tracts after liver and kidney biopsies. Bio-Seal has already been granted FDA clearance for the lung.