"Small bowel endoscopy is currently limited by problems of discomfort and failure to advance far into the small bowel", stated one of the study authors Paul Swain, MD, a professor of gastroenterology at the Royal London Hospital, United Kingdom. "This is the first time that we have been able to achieve painless endoscopic imaging of the entire small bowel."
The wireless endoscopy system utilised by Dr. Swain, has been developed by the Israeli-based company Given Imaging and features three components:
- M2ATM Swallowable Imaging Capsule - a patented, video colour-imaging disposable capsule which is swallowed, glides smoothly through the digestive tract and is naturally excreted. Through the use of miniature electronics and complementary metal oxide silicone technology, the M2ATM capsule can transmit high-quality video images using lower power consumption than charged coupled devices.
- Wireless recorder worn on a belt around the waist which receives signals transmitted by the capsule through an array of antennae placed on the patient's body. The ambulatory belt permits users to continue about their daily activities during the "GI examination".
- Computer workstation, equipped with Given's proprietary RAPID or Reporting and Processing of Images and Data software, which processes the data and produces a short video clip of the small intestine and additional relevant information from the digestive tract. The Given workstation will permit physicians to view, edit and archive the video, and save individual images and short video clips.
The key to the success of the system constitutes miniature electronics and complementary metal oxide silicone (CMOS) technology, allowing the capsule to transmit high-quality video images with much lower power consumption than with charged coupled devices (CCD). Silver oxide batteries power the camera, white light emitting diodes (LED) and the transmitter within the capsule.
The data presented and published includes results from animal research and human volunteers. The system provided over five hours of recorded images from the gastrointestinal tract. Patients reported that the capsule was easily swallowed and caused no discomfort. The capsule, which is propelled by peristalsis, the natural contraction and relaxation of the intestine, was able to successfully transmit video images throughout the entire small bowel (pylorus to cecum), and reached the first part of the large intestine in less than two hours.
Dr. Paul Swain noted that the image window on the capsule remained clear throughout the whole transmission and that he was able to continuously track the position of the capsule as it moved through the patient's small intestine. "The successful development of a wireless endoscopy system which can transmit and record clear video images of the human small bowel is a real breakthrough for diagnostic imaging", stated Dr. Swain.
During the development phase of the system, alternative methods have been tested to store the images on a memory chip within the capsule. After their trip across the patient's body, the images could be analysed afterwards. It proved to be extremely difficult though to install sufficient memory capacity on such a tiny little space. The present version has the advantage that the medical specialists can view the images right away.
For the capsule design sensors and techniques have been applied that have been developed by Nasa to measure the vital body functions of astronauts. Human trials in the United States are planned for this summer as a part of Given Imaging's plan to obtain 510k clearance of the device from the United States Food and Drug Administration in the United States by the end of the year.
Given Imaging Limited is an Israeli-based company established to develop, produce, and market an innovative platform technology for diagnostics and therapy of the gastrointestinal (GI) tract. Given maintains its corporate headquarters, research and development laboratories, and production plant in a newly constructed 25.000 square-foot facility in Yoqneam, Israel. The company's North American headquarters are located in Norcross, Georgia.