Development of a tamponade for vacuum assisted percutaneous core breast biopsy

Severe hemorrhage occurs in up to 7% of all vacuum assisted breast biopsy procedures. The current standard of practice to stop hemorrhage is the use of external pressure to the breast. While this can control minimal bleeding it is not localized enough to stop serious bleeding. If bleeding cannot be controlled through exterior pressure the only treatment is to perform surgery on the patient which is an unacceptable outcome. The proposed design will alleviate this problem through the use of a balloon mechanism with a biodegradable sheath covering. The system will apply internal pressure to the hemorrhaging area and will be removed without further injury to the biopsy site. The system will decrease the amount of time needed to stop the hemorrhage and prevent the need to perform surgery on a patient who has not been adequately prepared for surgery.