Research Project
9846944
Project Summary The goal for this project is to develop a novel, low cost, solution to clean a laparoscope in-vivo. The trend of laparoscopy is rapidly rising globally due more favorable quality of life outcomes when compared to numerous other surgical methods, especially those previously considered for open-surgery. However, when lens clarity is impaired via condensation or the smearing of bodily fluids/tissues excessive medical and monetary losses are incurred on hospitals, patients, clinicians, and third-party payers. PROPOSED SOLUTION The novel solution allows for rapid and easy cleaning of laparoscopes in-vivo, negating the need for scope removal from the body. The technology employs an elegant solution, allowing for seamless implementation in surgical procedures and minimal training to encourage successful clinical efficacy and adoption while addressing one of the most common issues to occur in laparoscopic procedures. The in-vivo lens cleaning device is comprised of an elongated sheath that fits around the laparoscope and inside a corresponding port. At one end of the sheath, a handle rests ready and available for cleaning actuation via end-user interaction with a small knob. At the distal end, a cleaning component is robustly secured to the device, awaiting actuation from the user. Specific Aim 1 ? Verification of technology efficacy, surgical integration, and safety. The prototype design will be tested to verify design/prototype performance of key metrics that confirm thresholds needed for clinical adoption. Three key performance metrics to be tested relate to (1) lens-cleaning efficacy (2) insufflation gas leakage and (3) mechanical strength, durability, and resiliency testing. All testing metrics will be objective, but an additional subjective measure will be integrated into lens-cleaning efficacy testing to obtain a direct understanding of surgeon-preferred thresholds for a ?clean lens? to better guide device design and development. Specific Aim 2 ? Validate prototype design performance, ergonomics, and usability in cadaver model testing with 20+ clinicians. The verified prototype design will be tested in two cadaver labs by 20 clinicians. Aim 2 will be conducted in two full iterations to allow for implementation of valuable design feedback from clinician end-users, in time for a second cadaver lab. Prototype performance and clinician interview data will be acquired before, during, and after device utilization. A variety of different procedures will be performed with an emphasis on (GI), GYN, and general surgeries, as these fields are some of the most common for laparoscopic application. Data will help to confirm the likelihood of clinical adoption. IMPACT AND BENEFITS Successfully addressing the aforementioned problem stands to reduce surgical times, post-surgical site infections, and surgical complication rates while improving surgical safety, resulting in more efficient and safer surgeries for patients and clinicians. Such impacts stand to further reduce hospital readmission rates. In addition to improved surgical outcomes, implementing the low-cost device should effectively decrease economic burdens on hospitals, improving overall value of care.
