Longstanding issues with traditional colonoscopies have led a medical device company to engineer a better solution—a simpler, single-use endoscope that is more flexible, more controllable, and less likely to result in injury or infection.
It’s one of healthcare’s dirtiest secrets.
Each year, millions of Americans are screened for colorectal cancer using a common medical apparatus called an endoscope. This reusable, snake-like device consists of a controllable, multi-layer flexible tube with a light, camera, and tool for taking biopsies on one end, and an eyepiece or video hook-up on the other.
Clinicians insert it through the rectum into the patient’s gastrointestinal tract, manipulating it through the bowels to identify potential pre-cancerous polyps and other issues before they grow into full-blown cancer. Yet, given the environment in which this tool works—the body’s messy waste repository—endoscopes can easily pass bacteria from patient to patient if they aren’t cleaned and sanitized properly.
“Hospitals need a special, and quite expensive, disinfecting washing machine to clean conventional endoscopes,” says Ido Agmon, head of business development at Israel’s Consis Medical, a medical device start-up. “The problem with cleaning those is the long, narrow tube inside the scope. It can be difficult to make sure that it gets fully sterilized. That can lead to infections when the endoscope is reused in a new patient.”
Such infections aren’t hypothetical. Over the past few years, endoscopes have been identified as the culprit behind hundreds of potentially deadly illnesses across the US, including Carbapenem-resistant Enterobacteriaceae (CRE), a bacterium that kills about half of all patients who end up with this superbug in their bloodstream.
That is not the only issue with traditional endoscopes. Their design, requiring a pushing force from the rear end of the tube to move the front through the twists and turns of the human colon, can result in small tears in the tissue that can lead to subsequent injury or infection even when the device has been properly sanitized.
These longstanding issues have led several medical device companies to wonder if they can’t engineer a better solution—a simpler, single use endoscope that is more flexible, more controllable, and less likely to result in injury or infection.
Consis Medical is one such company. Its goal is to build a disposable, self-propelling device. Founder and CEO Alexander Polischuk developed the company’s unusual approach several years ago when he was part of a project that used an inverted balloon to transport a camera through tunnels.
“In Israel, we have a problem with terror tunnels at the border,” Polischuk says. “I was working with a company developing a device using a water-inflated sleeve to self-propel a camera into the tunnel to see whether or not there might be explosives or other things in the tunnel.
“Such a device can be used for homeland security, of course, but also to send sensors down into industrial pipes,” he says. “Once we had the first prototype, we thought it was a concept that might also work for medical uses, assuming we can make it move the right way in a small cavity.”
But could he? Polischuk and his colleagues had to create an inflatable, inverted, single-use balloon with a pill cam at one end that could safely propel itself by water inflation through the lower intestine. Then, at the end of the procedure, they would toss the balloon, leaving only a small, easy-to-clean pill cam left to disinfect for future use. They ultimately did just that, but it took some time to come up with the right design.
“Unfortunately, what works well in large scale doesn’t always work as straightforwardly in small scale,” Agmon says. “We needed to redesign the system so that it could work in a small dimension, as well as meet medical device requirements. It involved moving from a 100-meter prototype to a 2-meter one.”
Other companies had failed by designing systems that were too complex—and too expensive. As Consis Medical developed its tunnel-inspired prototype, it relied on simplicity to guide them. A water system, not unlike one you’d find in your dentist office, inflates an inverted film sleeve. This propels it forward as water fills and expands it, much like a conventional balloon. It naturally follows the contours of the colon as it expands. If doctors catch a glimpse of a potential problem, they can simply reduce the water pressure and use simple hand controls to allow the endoscope to take a closer look.
“The genius of our solution is just how simple it is,” Polischuk says. “It’s just a single, inverted biocompatible lumen balloon. By using water to inflate it, it has the same amount of force at both ends of the balloon. It’s easily controlled, and that ability to transfer force directly makes the colonoscopy penetration quick and safe. And since you can throw away the balloon after one use, you don’t have to worry about spreading infections.”
The prototype has been tested in animals, and it is hoped that clinical trials will start within the next 12 months. Agmon is confident that Consis’ straightforward design will help clean up the problem of endoscopic infections in the future.
“This device can reduce infections and costs of this very common medical procedure while improving therapeutic performance,” Agmon says. “It’s what hospitals need to help them safely screen their patients for cancer in the future.”
Kayt Sukel is an independent technology writer based in Houston, TX.