Feasibility and Safety Study of LapSpace, A Novel Laparoscopic Surgical Instrument

The field of laparoscopy has been growing exponentially during the past decade because of its tremendous benefits over open surgery such as minimal incisions, lesser post-operative trauma, quicker recovery, lesser scarring, reduced hospital stay and lower infection rates. It is clear that the success of any laparoscopic surgery lies on the optimal exposure of the operative site. Surgeons and assistants are required to tightly strap the patients on the surgical bed, continuously change the patient's position in order to use gravity to hold the bowels out of the way and finally result in manual over manipulation of bowels and organs using graspers in order to achieve the optimal exposure of their site. However, small bowels or organs cannot be held back efficiently using these techniques and slide continuously into the operating area.

In practice, the obstruction of the surgeons' visual field and the excessive manipulation of the bowels cause unintentional injuries, bleeding, bruising, hematoma and perforations that might require patients to undergo

additional surgeries because of scar tissue formation. The U.S market for scar tissue prevention products is estimated at a staggering $2-3 billion. Furthermore, the current standard of clinical care forces surgeons to add procedural steps in the operation in order to minimize possible complications. However, these extra steps further extend the duration of the operations, leading to a loss of money and reliability on behalf of the hospitals.

The device owners bowel retractors eliminate the time-consuming mobilization of the small intestines while they stabilize the bowels, allowing for a clear view of the operative site. Given the increased demand of laparoscopic surgeries in which the device owners device is helpful (approaching 5 million surgeries per year) the time saved after only a few uses of the device owners device is significant enough to benefit hospitals in allowing them to host another surgery that is waiting in the backlog. The device owners devices, thus, are not only beneficial for the patients since they minimize trauma and complications but also highly profitable for the hospitals.

The proposed device contains a variety of novel features, which are enumerated henceforth. The device owners device will be inflatable and will have inflatable "ribs" at the grasping terminal of the device. The ribs will work in tandem with the mechanism of inflation in order to adequately grasp the desired portion of bowel in the abdominal cavity. In addition, the device owners device will be firmly attached to a solid steel center rod, with which the surgeon can maneuver the device. The solid rod will also contain a sliding seal, such that after the device has been inserted into the abdominal cavity, the seal can be slid into place and will serve to effectively anchor the device on the abdominal wall. On the end of the rod near the surgeon, there will be an attached handle with a trigger. This handle system will be used to inflate the device by pulling the trigger and allowing compressed air through the central rod. The handle will also be the point of contact between the surgeon's hand and the device owners device, allowing him further maneuverability throughout the procedure.