Multimodal KeyScope Laparoscope: Increasing Access to Laparoscopic Surgery - ABSTRACT Laparoscopic surgery, which avoids large incisions by using a tiny camera and fine instruments manipulated Laparoscopic surgery, which avoids large incisions by using a tiny camera and fine instruments manipulated through keyhole incisions, is the standard of care for most surgical procedures in the chest and abdomen as it significantly reduces post-surgical mortality and morbidity compared to open surgery. While laparoscopic surgery has clear advantages over open surgery, utilization of laparoscopy varies widely across the United States. Rural hospitals are less likely to perform laparoscopy because of the scarcity of specialized surgeons trained in laparoscopy and a lack of laparoscopic equipment, surgical staff, and support in rural areas. Rural hospitals often cannot afford expensive laparoscopic equipment, especially if they treat a low number of patients each year. Laparoscopic surgery is also needed in combat zones to treat abdominal trauma and has been shown to reduce postoperative complications, infection, and recovery time, leading to a faster return to duty compared to open surgery. However, depending on the location of combat, state-of-the-art surgery centers and associated laparoscopic equipment are often not accessible near the point of injury. Each operating room requires an expensive laparoscopic camera, viewing monitors and related equipment (>$130,000 for initial purchase in each room) and access to electricity and consumables needed to perform surgery. Further, current technology uses fragile fiber optic cables and cameras that require constant repair, necessitating expensive service contracts. Thus, laparoscopic surgery is rarely accessible in the settings described above due to the high cost of installment, unreliable electricity, shortage of consumable supplies, and lack of qualified personnel needed to maintain and repair equipment. To address this unmet need, we are developing a low-cost, durable, reusable laparoscopic system, called the KeyScope laparoscope. Rather than using fiber optic cables, the KeyScope contains light emitting diodes (LEDs) and a color complementary metal-oxide-semiconductor (CMOS) detector that is moved to the front of the device. This ultimately will enable a significant decrease in cost and complexity (to a target of <$1,000). Our approach is innovative and unconventional because the KeyScope is designed to be more affordable, portable, robust, maintenance free, compatible with simple sterilization methods, and independent of continuous electricity. Here we will significantly improve upon the initial design of the KeyScope through adding key functionality needed for various surgeries, including developing a 30° KeyScope laparoscope, which will enable surgeons to see different fields of view within the abdomen, and a fluorescence laparoscope, which will enable surgeons to visualize a commonly used contrast agent, indocyanine green. These novel designs will be systematically evaluated through bench testing, testing in an abdominal model, and in vivo testing in a pig model. Testing in a pig model is needed to ensure the safety and performance of the 30° and fluorescence KeyScopes are comparable to commercial laparoscopes prior to testing in humans. Pigs were selected because they have similar anatomy to humans and are commonly used to test surgical innovations and teach surgical skills.
