A Better Imaging Process from the Inside Out

Originally Published MDDI June 2002

MEDICAL DESIGN EXCELLENCE AWARDS 2002

Diagnostic Imaging System with M2A Capsule Endoscope

Submitted by Given Imaging Inc. (Norcross, GA); manufactured by Given Imaging Ltd. (Yoqneam, Israel)

When Given Imaging says its Diagnostic Imaging System with M2A Capsule Endoscope "is not about incremental improvements," the company is not exaggerating. The imaging system combines many firsts—a new way of testing patients, the first time a thorough diagnosis of gastrointestinal (GI) troubles can be provided, and the first uses of various technologies in the GI arena.

The imaging system uses a miniaturized video camera contained in a capsule the size of a large vitamin pill. It is swallowed by the patient to deliver high-quality, color images of the GI tract in a painless, minimally invasive manner.

After fasting overnight, a patient goes to the doctor's office or hospital, where several sensors are placed on his (or her) abdomen and a belt with a data recorder the size of a handheld computer or PDA is affixed to his waist. He then swallows the capsule and goes about his daily business—going to the office, etc. Four hours later, he may eat, and four hours after that, he returns to the hospital, where the doctor downloads the data from the belt and reads the images from the capsule's eight-hour journey through the natural contractions of the GI tract.

"Two other imaging systems are commonly used for the small bowel, but both have serious drawbacks," says Mark Gilreath, president of Given Imaging Inc. "X-ray radiology typically doesn't see flat lesions or bleeding, which results in a diagnostic yield of less than 5% in patients with obscure bleeding. The second method, push endoscopy, reaches only one-third of the way into the small intestine. The small intestine is a 21-foot-long organ, so that's a lot of unexamined real estate. Before the M2A Capsule Endoscope, there was no good way to image the entire organ."

In addition, traditional endoscopic procedures require sedation and insufflation, or the forcing of air into the gastrointestinal tract, which may cause great patient discomfort and can hide bleeding by temporarily applying pressure. The M2A Capsule allows physicians to view the intestine in its natural state without placing the patient under sedation or the physical stress of pushing a long endoscope down the patient's throat.

In the mid-1990s, an Israeli researcher was looking into ways to better study the GI tract based on conversations with a physician friend. In 1998, Given Imaging was founded by CEO Gavriel Meron, and a research team was put in place to make the dream a reality.

"The R&D team faced tremendous challenges while developing a miniaturized optical system, energy system, illumination system, and video electronics in a wireless environment. Integrating all of these components—combining video production technology with miniature hardware and proprietary software—required a unique, talented team," Gilreath says.

While video endoscopes tend to use charged coupled device (CCD) chip technology, Given Imaging focused on finding a way to use the complementary metal-oxide semiconductor chip technology (CMOS) that is popular in today's digital cameras in its M2A Capsule. "Being able to use CMOS in this application meant that we'd be able to mass-produce a more cost-effective device that had lower energy requirements than the CCD chip does," Gilreath explains.

In the past, one obstacle to using CMOS chips in medical imaging applications has been their delivery of lower-quality images. Given Imaging overcame this hurdle by improving the optical system and developing software to process the images downloaded from the minicamera. Given's RAPID (Reporting and Processing of Images and Data) software lets physicians freeze a frame for later review and annotation, provides both streaming video and image-by-image viewing, and allows for JPEG files of frames to be sent to consulting experts.

And instead of using plug-in fiber optics and lamps to illuminate the GI tract, Given Imaging put four light-emitting diodes (LEDs), as well as a lens, a color camera chip, two silver oxide batteries, a radio-frequency transmitter, an antenna, and magnetic switch in its capsule. "This is another first in the world of endoscopy —using LEDs to illuminate the GI tract," Gilreath notes.

While Given Imaging has completed many firsts in its development of its MDEA-winning product, the company is proud of the system for a traditional reason. "In the healthcare industry today, many great technologies are looking for a practical application," Gilreath says. "Coupling exciting technologies with meeting an unmet patient need—in this case, helping patients with chronic conditions like Crohn's disease, inflammatory bowel disease, intestinal cancer, or undiagnosed bleeding—makes a truly compelling story."

Copyright ©2002 Medical Device & Diagnostic Industry