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Development of a Disposable Use Endoscopy Tool

Final Report Summary - DUET (Development of a Disposable Use Endoscopy Tool)

Endoscopes are miniature, elongated microscopes that physicians use to perform minimally invasive procedures on patients - in their hollow organs or invasive canals. Infection in patients can occur due to inadequate cleaning of endoscopes and instruments which pass through endoscopes.

In the early 1900s, the first attempts to view inside the body with lighted telescopes were made. These initial devices were often fully rigid. In the 1930s, semi-flexible endoscopes called gastroscopes were developed to view inside the stomach. South African born physician Basil Hirschowitz at the University of Michigan in 1957 pioneered fibre-optic endoscopy. Widespread use of the fibre optic endoscopes began in the 1960s. Until the last few decades, exploratory surgery was routinely performed when a patient was critically ill and the source of the illness was not known. A typical modern endoscope has two fibre optic lines, a light fibre carries light into the body cavity and an 'image fibre' carries the image of the body cavity back to the physician's viewing lens. There is also a separate port to allow for the administration of tissue excision (removal), sampling or other diagnostic and therapeutic work. Endoscopes may be used in conjunction with a camera or video recorder to document images of the inside of a body. New endoscopes may also have digital capabilities for manipulating and enhancing the video images and an internal system makes it possible for the physician to control bending of the instrument, referred to as distal-end angulation. Flexible endoscopes contain either an electronic video camera chip or glass fibres to produce or 'return' images for the physician to view. Modern sterilisation methods place high demands on both materials and their processing and are not fully functional in eliminating infections, disease and death from the re-use of these instruments.

Recently, a new disposable capsule endoscope has received FDA approval for use in patients. Developed by Given Imaging, the M2A capsule involves ingesting a small (the size of the large vitamin pill) capsule, which contains a colour camera, battery, light source and transmitter. The camera takes two pictures every second for eight hours, transmitting images to a data recorder about the size of a portable CD player that patients wear around the waist. Once swallowed the camera moves naturally through the digestive tract while patients carry out their normal activities. The capsule endoscope is disposable and will be egested naturally.

In this project, a team of SMEs developed single use endoscopy instruments which will eliminate the possibility of infection of the patient from this equipment. The technology developed in this programme will be applicable to other equipment developed by the SMEs. An additional aim is for the disposable endoscopy equipment to be constructed from materials which can be recycled after use.

This project has demonstrated the feasibility of the use of disposable endoscopic tools. They can be cost effective, fit for purpose and suitable for safe disposal and, in due course, recycling. The demonstration of the feasibility of the single use equipment means that endoscopy can potentially be used much more flexibly than before. Currently, it is deployed in specialising hospitals due to the infra-structure required. Single use equipment has the potential to change this to a much more flexible approach where a concentration of equipment (endoscopes, monitors, cleaning equipment, etc), and specially trained people (cleaning technicians etc) is no longer necessary. This equipment may also in due course bring down the cost of endoscopy, making it more accessible.

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