With up to 4.8 million procedures annually in the U.S., laparoscopy has rapidly become the surgical standard for a wide range of procedures. Compared to open procedures, laparoscopic approaches reduce muscle damage, blood loss, post-operative pain, complication rates, and length of hospital stay. However, laparoscopy has unique technique-specific limitations and complications, so the perception that minimally invasive surgery is minimally traumatic is imprecise. There is now evidence that the frail, aging population may benefit most from laparoscopic techniques. Thus, advances in laparoscopic techniques that reduce surgery-related complications would provide important benefits to the older patient population. Although laparoscopy has generally improved surgical outcomes, current instruments can contribute to procedure-related complications. To grasp and manipulate tissue, surgeons typically use the compressive grasper, a tool that pinches tissue between the teeth of two jaws. While compressive graspers are well-suited for grasping smaller structures, the typical V-shaped jaws only open to a maximum of 3.5-10 mm apart, so they are not optimized for grasping larger structures, particularly stiff structures like the inflamed gallbladder. As a result of the compressive grasper?s design, excessive grasping and retraction forces, long duration of grasps, and slippage of the tissue in the grasper jaws can all contribute to tissue injury and perforation. In turn, intraoperative tissue damage can lengthen operative time, result in conversion to traditional open surgery, and increase patient morbidity. In addition to immediately apparent damage, tissue injury during surgery can result in delayed perforations and significant patient morbidity. Therefore, the risk of iatrogenic tissue injury is a central and ubiquitous concern for surgeons. To address the need for a laparoscopic grasper capable of gripping a broad array of tissue types without the risk of slippage or iatrogenic injury, TheraNova is developing the Lamprey Grasper, a novel, atraumatic laparoscopic grasper. Our goal is to improve key functionalities within the grasper family, particularly in grasping larger, stiffer structures. In preliminary studies, we demonstrated that several Lamprey Grasper designs enable a strong, reliable tissue grasp while inducing less injury than a compressive grasper. The overall goals of this proposal are to build on this promising work to optimize and validate the Lamprey Grasper.
In Specific Aim 1, we will conduct a benchtop evaluation to identify the optimal Lamprey Grasper design for robust grasping across a range of porcine abdominal tissues.
In Specific Aim 1, we will use the optimal design from Aim 1 to conduct a comprehensive in vivo evaluation of the Lamprey Grasper vs. a conventional compressive grasper. Two experienced laparoscopic surgeons will perform a series of laparoscopic actions in Yorkshire pigs (n=6) to compare functionality, usability, and grasper-induced tissue injury between the two graspers. If this Phase I work is successful, in Phase II we will conduct a large, post-operative survival animal study to validate the functionality, usability, and safety of the Lamprey Grasper, which will support a 510(k) submission to the FDA.
Laparoscopy has generally improved surgical outcomes for appropriately selected patients, but current laparoscopic tissue graspers can contribute to procedure-related complications through grasping-inducing tissue injury or perforation. There is now evidence that the frail, aging population may benefit most from laparoscopic procedures, so advances in laparoscopic surgery that reduce complications would provide important benefits to the older patient population. In this SBIR Phase I, we propose to optimize a novel laparoscopic instrument capable of grasping a broad array of tissue types without the risk of slippage or traumatic injury.
