The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.The ASC PneumoLiner Device has two main components. It consists of:1. The PneumoLiner, a tissue pouch intended to provide a space within the abdomen for the safe morcellation of tissue; and2. A laparoscopic multi-instrument port.1. Multi-instrument PortThe laparoscopic multi-instrument port is comprised of the following three sub-components:The Retractor Introducer which delivers the Distal Ring of the Retractor through a premade incision, into the abdominal cavity.The Retractor which retracts an abdominal incision to allow the passage of laparoscopic instruments and provides an anchor for the Valve Component.The Boot Assembly which maintains the pneumoperitoneum established for the surgical procedure.2. PneumoLinerThe PneumoLiner, has two sub-components:An Introducer for delivery of the PneumoLiner.The PneumoLiner, that when under pneumoperitoneum provides a space for morcellation of the chosen tissue that can be visualized.
An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.
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