VIENNA, Austria — The evolution of surgical medical technology is headed down the path of de-evolution in the search for intelligent design.
"Worms, snakes, lizards and ants, these are some of the models of natural locomotion being studied today" for robotic interventions of the future, said Professor Guida Costamagna from the Agostine Gemelli University Hospital of the Catholic University of Rome in his address during the 16th annual United European Gastroenterology Week here.
"Capsule cameras have certainly changed the horizon," he said, but now designers are going further to create a bug for drugs and detection.
"People are afraid of endoscopes, we need something less aggressive," said Costamagna, citing two European projects for robotic capsules that are "more active, that actually do something or are remotely piloted to perform procedures such as tissue sampling."
Funded by the European Commission, the Nano-based capsule endoscopy with Molecular Imaging and Optical Biopsy (NEMO) program will combine capsule endoscopy with nano-based molecular recognition to highlight cancerous lesions in the digestive tract, while the Versatile Endoscopic Capsule for gastrointestinal TumOr Recognition and therapy (VECTOR) project is building a robotic beetle, for advanced diagnostics and therapy.
Costamagna also highlighted a program for building a worm to navigate the digestive track that is under way at the University of Pisa (Pisa, Italy).
Moving from blue sky to the near horizon, he said trends already well-represented in endoscopy should be enhanced, citing as an example the introduction of image analysis and expert systems for reading endoscopic images.
"It is here already, but there are a confusing number of possibilities and what we need is red-flag technology to analyze muscosal tissue and then we need to apply a second technique to characterize the tissue," Costamagna said.
The integration of diverse technologies into traditional endoscopic devices will continue into the future, he said citing ultrasound applications that will be able to not only identify tissue but to aid the delivery of therapies to that tissue.
Novel visualization technologies allow a high magnification zoom up to even the cellular level enhancing the trend toward "optical biopsy," the in situ/in vivo evaluation for real-time diagnosis that previously was possible only with histological or cytological analysis.
Minimally invasive surgeries are expanding the potential of traditional endoscopy practice moving toward hybrid procedures such as single incision surgeries and even further to zero-incision procedures demonstrated in July in New York with the transoral gastroplasty (TOGA) procedure where surgeons entered the patient's stomach through the mouth for weight loss surgery.
Natural orifice transluminal endoscopic surgery (NOTES) it is the fashion today, he said, but poses a challenge to training the next generation of gastroenterologists who increasingly will be performing surgeries, not only identifying disease but injecting, cutting and treating that disease.
In one slide Costamagna showed what he called a primitive prototype of the Holy Grail of endoscopy developed by Olympus (Tokyo), a "triangulation device" with three movable arms that would enable interventionalists to reach out from the scope and touch the tissue under examination.
Olympus previews 'swinging' endoscope
Under the heading of "Merging Technologies," off to the side of the massive Olympus booth, Julia Peters was demonstrating the R-Scope, the front end of the company's developments toward NOTES procedures. Still a work-in-progress, the R-Scope is fresh from the research center in Japan and was being presented to stimulate interest and ideas from the passing interventionalists.
Olympus introduced the device this past June at the European Association of Endoscopic Surgeons meeting in Stockholm, Sweden, during a panel discussion on single-incision surgery.
"Laparoscopy is becoming less invasive and endoscopy is becoming more interventional," explained Peters, an application specialist for NOTES with Olympus Medical Systems Europa (Hamburg, Germany). Her mission at UEGW was to demonstrate the R-Scope and listen for insights and ideas, she said.
The key feature of the device is a swing function given to the two working channels on a standard Olympus Exera II endoscopic platform. One channel is dedicated to vertical movement, or up-and-down control, while the other is perpendicularly opposed, with a horizontal or side-to-side movement.
"One application could be endoscopic submucosal disection," suggested Peters, where one channel is equipped with a tool for holding tissue while a cutting tool is inserted into the second channel to slice the tissue.
Olympus currently offers a gastroscope and a colonoscope that each features two channels limited to in-and-out, or straight, movement.
The new swing channels give a degree of greater action for the existing line of Olympus endotherapy tools for Exera II endoscopes that include biopsy forceps, grasping forceps, clip-fixing devices, surgical scissors, needle knives, ligating devices and snares.
Groups of gastrointerventionalists clustered around the device, playing with the controls to experience the unusual function. One was given permission to make a video of the endoscope's action, which he did with the sincerity and seriousness of a film director.
Peters confirmed that Olympus engineers back in Japan are working on the three-channel device Costamagna showed in a slide during a plenary session that would give a "triangulation" function. But she said the device is not yet ready for prime time at any exhibition.
Pentax promotes push-pull double balloon
Front and center at the Pentax (Tokyo) booth was an Israeli team demonstrating a push-and-pull device for working an endoscope through the small bowel.
First introduced by Fujinon Europe (Willich, Germany), double ballooning of an endoscope overcomes the challenges that so far have prevented endoscopic views of the small bowel to the point where another Israeli company, Given Imaging, (Yokneam) has made a $100 million global market with capsule cameras to deliver images from down under.
Gadi Terliuc, CEO of Smart Medical Systems (Ra'anana, Israel), explained that the conventional way for an endoscope to push into the lumen of larger digestive tracts is not effective in the bowel, which is not only very long but also twisted and not strongly attached to the body cavity, such that it resists pushing.
Smart Medical developed a disposable, single-use device that can be attached to the outside of any standard endoscope from any manufacturer and for any model.
A sleeve with a balloon is slipped onto the head of the endoscope and the trailing catheter is secured along the length of flexible endoscope using silicon bands.
The endoscope is advanced to the first limit of forward movement, the point of resistance against the bowel lumen where it can not safely go further, and the balloon is inflated to anchor the endoscope at this point in the passage.
The interventionalist then advances a deflated balloon on the tip of a supple catheter inserted through the external strap-on Smart Medical channel forward into the bowel to a second point where the balloon is then inflated, thereby setting a forward anchor.
Between these two anchors, the wire guide of the catheter is sufficiently rigid to serve as a rail for pulling forward the endoscope which can now function as required in the space created.
UEGW marks the official launch of the system, said Terliuc, which to this point has been placed at several European university medical centers, including the University Hospital of Mainz in Germany, King's College in London and the Hospital Clínico San Carlos de Madrid in Spain.
There are two benefits of this add-on system, he said — the cost-effectiveness of a simple air inflation system and then the flexibility for the endoscopist to tailor the push-pull system to any endoscope of choice, such as a gastroscope or endoscopes with wide or double instrument channels.
Pentax Europe (Hamburg, Germany) is the designated distribution partner for Europe, the Middle East and Africa (EMEA), excluding Israel, where Terliuc said Smart Medical deals directly with 10 medical centers.
The device received a CE mark in April 2006, clearing its distribution in Europe, and for the U.S., Terliuc said, "everything is open and we are in discussions now." The device received an add-on approval for small-bowel endoscopy from the FDA in August 2006.
Over at Fujinon, the general manager for medical products in Europe, Peter Jurkowski, told Medical Device Daily the double balloon push-pull system has reached an installed base of 1,000 units worldwide, with 180 units placed in Germany.
Though the system is an external add-on to the endoscope, using a full sleeve to cover the catheter rather than the silicon bands, he confirmed it is dedicated system for Fujinon endoscopes as the inner diameter of the outer sleeve must fit the specific dimensions of the endoscope.
"We used it once with one a different manufacturer's endoscope in an emergency situation," Jurkowski said.