CLEARCAM INC — Department of Health and Human Services SBIR Phase I: NIBIB

Description

Project Summary The goal for this project is to develop a novellow costsolution to clean a laparoscope in vivoThe trend of laparoscopy is rapidly rising globally due more favorable quality of life outcomes when compared to numerous other surgical methodsespecially those previously considered for open surgeryHoweverwhen lens clarity is impaired via condensation or the smearing of bodily fluids tissues excessive medical and monetary losses are incurred on hospitalspatientscliniciansand third party payersPROPOSED SOLUTION The novel solution allows for rapid and easy cleaning of laparoscopes in vivonegating the need for scope removal from the bodyThe technology employs an elegant solutionallowing 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 proceduresThe in vivo lens cleaning device is comprised of an elongated sheath that fits around the laparoscope and inside a corresponding portAt one end of the sheatha handle rests ready and available for cleaning actuation via end user interaction with a small knobAt the distal enda cleaning component is robustly secured to the deviceawaiting actuation from the userSpecific AimVerification of technology efficacysurgical integrationand safetyThe prototype design will be tested to verify design prototype performance of key metrics that confirm thresholds needed for clinical adoptionThree key performance metrics to be tested relate tolens cleaning efficacyinsufflation gas leakage andmechanical strengthdurabilityand resiliency testingAll testing metrics will be objectivebut an additional subjective measure will be integrated into lens cleaning efficacy testing to obtain a direct understanding of surgeon preferred thresholds for aclean lensto better guide device design and developmentSpecific AimValidate prototype design performanceergonomicsand usability in cadaver model testing withcliniciansThe verified prototype design will be tested in two cadaver labs bycliniciansAimwill be conducted in two full iterations to allow for implementation of valuable design feedback from clinician end usersin time for a second cadaver labPrototype performance and clinician interview data will be acquired beforeduringand after device utilizationA variety of different procedures will be performed with an emphasis onGIGYNand general surgeriesas these fields are some of the most common for laparoscopic applicationData will help to confirm the likelihood of clinical adoptionIMPACT AND BENEFITS Successfully addressing the aforementioned problem stands to reduce surgical timespost surgical site infectionsand surgical complication rates while improving surgical safetyresulting in more efficient and safer surgeries for patients and cliniciansSuch impacts stand to further reduce hospital readmission ratesIn addition to improved surgical outcomesimplementing the low cost device should effectively decrease economic burdens on hospitalsimproving overall value of care Project Narrative The scientific premise for the proposed project stems from the fact that laparoscopic surgeries are vastly growing in popularity in the US and worldwideyet there is still great need for technological improvements to benefit the vast number of stakeholders involvedi epatientsclinicianshospitalsand payersMore specificallyone of the most common and frustrating issues that occurs during laparoscopic surgerylens vision obstruction from debris deposition on the scope lensis still a major issue for this advanced field of medicineThe verification and validation of a novel in vivo laparoscope cleaner stands to benefit numerous stakeholders regarding medical and economical outcomesThe translatable health goal of this research stands to address laparoscopic surgeonsmost commonconsistentand frustrating distraction experienced during laparoscopic procedures on a daily basisSuccessfully addressing this problem stands to reduce surgical timespost surgical site infectionsand surgical complication rates while improving surgical safety for resulting in more efficient surgeries for patients and cliniciansFurthermorecost savings and improved medical outcomes stand to improve the financial bottom line for hospital administrators and reduce readmission rates