Clinical Assessment of the Keyhole Cup Laparoscopic Surgery Access Device Dr.

Luis Miguel Cruz Melgar, MD

Instrumentation and modalities for laparoscopic surgery ( Keyhole Surgery) have evolved greatly over the past decade. The overall performance and utility of the various surgical instruments have allowed laparoscopic surgeons to expand their abilities to treat a greater breadth of medical conditions through laparoscopic intervention. The surgeon interface to these devices has evolved to a state of computerized robotics through the DaVinci System.

The majority of surgeries involving the abdominal or sub-abdominal areas are eligible for the laparoscopic technique. Major organ surgery including gall bladder, small and large intestine, uterus, and stomach are all accessible through this technique. Procedures utilizing the laparoscopic technique requires the surgeon to gain access to the abdominal cavity using either a Veress needle or a trocar device/endoscope and through that, infuse inert gas into the abdominal cavity to create a working space and provide visibility. A major concern during this access is preventing inadvertent injury to major organs or life-sustaining blood vessels. The initial insertion of the Veress needle is, at present, a manual system in which large clamps are attached to either side of the abdomen and the abdominal wall is manually lifted. The Veress needle is then inserted through the skin and muscle of the abdomen and inert gas is injected, until the abdomen is sufficiently insufflated. Injuries resulting from insertion of the Veress needle include injuries to major blood vessels, abdominal wall hematomas, bowel perforation, and puncture of the aorta. In these incidents, the mortality rate has been reported to be as high as 21%. Additionally, there are increased hospital stays and resultant increased health care costs. Alternative methods of gaining access to the abdominal cavity have developed as a form of risk mitigation to injury from the Veress needle access technique. These techniques, called the Scandinavian Method and the Hassan Method, involve scalpel-induced surgical openings into which blunt-tipped instruments, such as the trocar, are used to gain access through this cut down procedure. These openings are then sealed with clips or sutures, around the trocar, to prevent leakage, and the inert gas is inserted. These cut down techniques add additional time and steps relative to the standard Veress needle approach and have been developed primarily as an additional avenue to mitigate complications associated with the standard approach.

The Keyhole Cup Laparoscopic Access Device (Life Care Medical Devices Ltd) has been designed to add speed, elegance, and safety to the access procedure. Keyhole Cup is a dome shaped, polycarbonate device with a suction port to the lateral side and an injection site at the apex of the dome.

Keyhole Cup:

Keyhole Cup functions by utilizing negative pressure to raise the anterior abdominal wall above the vital organ bed creating a temporary pneumperitoneum. Once this temporary pneumoperitoneum has been created a veress needle can be introduced into the abdomen without risk of injuring any underlying organs. As inert gas begins its flow, the negative pressure is relieved gradually, the Keyhole Cup then removed and surgery commenced. My surgical experience involved a 62 year old male who was being treated for hiatal hernia. Following the Instructions for Use and preparation of the patient, I placed the Keyhole Cup with the injection site above the umbilicus, attached standard OR suction to the suction port on the Keyhole Cup and applied negative pressure. Several seconds later, at 4 bar, the abdominal wall rose into the dome shaped device, I inserted the Veress needle into the injection site and introduced CO2 into the space created by the device. Several seconds later, the negative pressure was relieved, the balance of the abdomen filled with CO2, the Veress and device was removed and surgery proceeded. Utilizing the Keyhole Cup device took under 30 seconds from execution to full insufflation. It should be noted that due to the lack of connective tissue between the anterior abdominal wall and the intestinal bed, only the anterior abdominal wall rises into the dome shaped Keyhole Cup. The intestinal bed remains intact. This was verified with the placement of a visualization trocar prior to negative pressure being applied. Conclusion: Based on our experience, the Keyhole Cup Laparoscopic Access Device is an excellent device to use in the initial access of the abdominal region for laparoscopic surgery. It is rapid, easy to use, and provides an element of safety not found in either a direct Veress needle or direct trocar method. To review a video of the procedure, visit www.keyholecup.com.