Major Advances in Colonoscopic Technology: The ColonoSight®, a Pull-Power Assisted Disposable, Non Fiber-Optic Colonoscope

Abstract

Since the introduction of the colonoscope, there has been some progress in the technology. However, a push from behind is still needed for scope advancement, disinfection is necessary between procedures, and fiber-optics require costly repairs. The ColonoSight® is a novel instrument which addresses all 3 issues. The device uses air pressure assisted pull technology that incorporates a disposable system. A pneumatic mechanism generates a forward force just below the tip of the scope, and simultaneously deploys a protective disposable sheath, as the scope advances in the colon. The forward force at the tip pulls the scope in, (while the operator navigates with the handles), thus drastically reducing the need to push from the back. The protective disposable sheath incorporates disposable work channels; therefore, no disinfection is needed between procedures, instrument downtime is cut and infection risk is reduced. The ColonoSight® utilizes integrated LED (light emitting diode) light source in the tip, eliminating the need for fiber-optics. Results: A prototype was used for colonoscopy in 12 pigs and 7 sheep, with no complications or adverse effects. Mean exam time was 12.4 ±10.8 minutes with insertion length of 117 ±26 cm. Three pilot clinical trials were done in Israel, Italy and U.S., the purpose of which was to determine the instrument operability and safety as well as the barrier properties of the disposable sheath. A complete screening or therapeutic colonoscopy was attempted in 72 pts, (9F,63M), mean age 50 ± 12 ys. Success rate in reaching the cecum was 88%. Mean time to reach the cecum was 12.3 ± 7 minutes, and in 9 pts it was reached in less than 5 minutes. Therapeutic interventions included biopsy, polypectomy and APC. There were no complications during the procedures or for the following 2 weeks. Findings included diverticulosis, polyps and hemorrhoids. Bacteriological cultures obtained post procedure from various areas of the ColonoSight® protected by the sheath showed that the sheath barrier was effective in protecting the non-disposable components. Conclusions: The animal studies and preliminary human trials indicate that the 3 novel functions of the ColonoSight®: 1) disposability (eliminating the need for disinfection, cutting down time of the instrument and protecting from infection), 2) power-assisted force at the tip to advance the scope (decreasing need to push), and 3) integrated LED illumination (eliminating need for fiber-optics) function well and safely.