The Nakao ZipSheath™ was invented in order to decrease transmission of infection during flexible endoscopy. The endoscope is designed to visualize hollow organs and contains channels through which surgical instruments are passed, and bodily fluids are suctioned. A long and arduous process of washing and sterilizing the endoscope is necessary after each procedure. The process entails manual washing & brushing of the channels and outer surfaces, sterilization, and subsequent re-washing in order to remove the toxic detergent. The effectiveness of the cleaning process depends entirely on the assistant's adherence to protocol. Studies have shown that even when protocol is followed to the letter, micro-organisms remain in the endoscope's channels. The reason for the difficulty in cleaning an endoscope properly is its elaborate passageways and narrow channels wherein adherent bio-burden is not always evident or easily reachable. To make matters worse, the chemicals used for cleaning an endoscope to are toxic and harsh, and may cause skin and eye injuries to the nursing staff.

The Nakao ZipSheath™ consists of a protective sleeve sealed with a double zip-lock mechanism. The distal tip of the endoscope is covered by a transparent air-tight tip with channel liners, while the endoscope shaft is encased by the sealed sheath. At the end of the procedure, the sheath is simply unzipped and discarded. This prevents bio-burden from entering the channels and encasing the outer shaft of the endoscope. Once the sheath is removed, the endoscope requires rinsing before being placed in the sterilizer. A ZipSheath with dilators and compression balloons may be used for treating strictures, or hemorrhage from esophageal varices. Sheaths with multiple channels enable insertion of operative instruments. The most recently issued patent (6,929,601 B2) discloses a sheath with longitudinal tear string such as used to open a chewing gum wrapper, enabling simple sheath removal.

Issued Patents
5,217,001
5,353,786
5,746,694
5,938,586
5,400,770
6,929,601 B2

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