Looking at Safety and Feasibility of Novel Laparoscopic Device (LapSpace)
Condition: Patients Undergoing Laparoscopic Surgery
Study type: Interventional

Summary: 
      In order to help the surgeons to clearly visualize their target operating area and create an
      optimal operative field throughout the procedure, the device owners have developed a new
      class of inflatable laparoscopic retractors for both bowel and organ specific retraction with
      load bearing bore by an inflatable reinforced material that is atraumatic, biocompatible, and
      are self-retained, i.e. require no personnel to maintain them post-placement.

      Specifically, the device owners menu of designs hold a range of 50 - 100 % of the bowels and
      support at minimum 6 lbs in the vertical direction. All the device owners devices enter the
      abdominal cavity through a conventional 10mm incision. The pressure within the inflatable
      tubes of the device will not be above 15 mmHg, which is the current pressure used to
      insufflate the patient's abdomen with carbon dioxide (CO2). The devices are able to retract
      up to 10 cm of the bowels in any direction within the coronal plane and retract the bowels
      10cm upward, towards the abdominal wall. Finally, the invention here-in described can be
      manipulated easily to provide retraction of specific organs, including, liver, bladder,
      uterus, etc.

      The device has been approved by the FDA for clinical use (FDA Registered) and the purpose of
      this study is to evaluate the device in laparoscopic operations for safety and feasibility.
    

Detailed description: 
      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.

      The product is a bowl-shaped device that is intended to be used as an organ or bowel
      retractor in laparoscopic surgeries. This device consists of a central, hollow rod made of
      steel that has a straight proximal end and a curved distal end. The aforementioned distal end
      of the device has an inflatable portion, the material for which encircles the central rod.
      The inflatable portion also contains tubular projections which emanate from where the
      material contacts the central rod out to the edges of the inflatable portion. These
      projections are denoted henceforth as "ribs". The inflatable material is a biocompatible
      polymer that can hold sufficient tension and pressure for the application of laparoscopic
      surgery. The ribs curve inwards, which create a bowl-like structure when fully inflated and
      deployed. Each of the ribs are connected to the central rod and to each adjacent rib via
      membrane, which is connected medially to the central shaft all along the distal, curved end.
      This creates a functional inflatable endoskeleton to support the bowels and organs that will
      be in contact with this device during laparoscopic surgery. The amount of inflation of the
      device can be modulated by the surgeon, by increasing or decreasing the inflation pressure as
      desired by adding more compressed air or withdrawing compressed air, respectively.

      The proximal end of the central rod will have a handle grip with a trigger attached to it.
      There will be an inlet for where a canister of compressed air will be positioned, such that
      when the trigger is depressed by the surgeon, air will flow down the length of the hollow
      central rod and inflate the device. The handle and grip

      will be attached such that the surgeon can deftly maneuver and retract the device after it
      has been inserted in the patient.

      The central rod will further house a sealing mechanism that can slide along the length of the
      rod, from the proximal handle to the distal end. This sliding seal will be affixed in place
      to the abdominal wall, allowing for a functional anchor and pivot point about which the
      retractor has many degrees of freedom with respect to movement, while still being supported
      by the seal to the patient's abdomen. A surgeon can choose to use a trocar in lieu of a
      sliding seal, which will have to be placed on the central before the attachment of the handle
      grip.

      After the device is in place after being fully inflated, it has the ability to grasp and hold
      the bowel in its concave interior region. The ribs help maintain the accurate shape and
      rigidity of the inflated portion, and thus will allow the device to remain flush against the
      bowel during retraction. The surgeon will then

      presumably pull the central rod to a more beneficial location, such that the operative field
      is no longer obstructed by the device. The surgeon can then affix the device to a surgical
      bed clamp, so as to free the surgeon from holding the device in place throughout the duration
      of the procedure.

      As of now, the device is to be utilized for laparoscopic abdominal surgical procedures.
      However, a similar or slightly modified product could be used for gynecological procedures as
      well, and would aid in the retraction or holding of pelvic or lower abdominal organs in those
      procedures. In addition, future variations of the design could be applicable to upper
      abdominal or cardiothoracic procedures as well. This device could also potentially be used in
      organ resection as well as retraction, in that modifications to the device could potentially
      allow it to clear the operative field while simultaneously being involved in organ excision.
    

Intervention name(s): LapSpace
Intervention type(s): Device
Intervention description(s): use of atraumatic laparoscopic retractor for patients undergoing laparoscopic surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility