The Cutting Edge Gets Smaller
Method: Take two magnets. Put one in the stomach and the other in the small intestine. Wait a week for the attraction between the magnets to alter the digestive anatomy and for tissue to grow around these changes. Redirect food exiting the stomach so it bypasses the duodenum to enter the small intestine further along its 10 feet of coils. Result: cure of adult-onset (type 2) diabetes mellitus.
This cure, now being developed for a disease endured by more than 285 million people worldwide (doubling their chances of early death and costing the global economy an estimated annual $612 billion), won its inventor, Dr. Yoav Mintz, the international Society for Medical Innovation and Technology’s International Prize last October. Dr. Mintz is no diabetes specialist. Director of the Innovative Surgery Center at Jerusalem’s Hadassah–Hebrew University Medical Center, he is a surgeon, and it was from this perspective that he developed his healing procedure.
“The technique mimics bariatric or gastric bypass surgery, which is typically performed for weight loss in the morbidly obese,” he says. “Gastric bypass has known benefits for patients with diabetes: Their disease resolves within days of surgery, before they lose weight—suggesting the cure is connected to changes in the anatomy.”
Complications from bariatric surgery are, however, frequent and can include infection and breathing problems, making it a procedure solely for those whose lives are at risk. “What we needed for diabetics was to imitate gastric bypass without performing invasive surgery,” says Dr. Mintz. “And that is what we have developed with the magnets and rerouting the food—both procedures accomplished safely and simply by endoscopy.”
Endoscopy and laparoscopy (also known as keyhole or minimally invasive surgery) have fascinated Hadassah-trained Dr. Mintz since his surgical residency in the late 1990s. A technique in which slender instruments are inserted through a tiny incision in the abdominal wall to visualize or operate on what is inside, laparoscopy speeds recovery and minimizes the bugbears of all surgery: pain, infection and bleeding. Preferred to open surgery wherever it can do the job, over three million laparoscopic procedures were performed worldwide last year. Dr. Mintz trained in San Diego with two of the field’s trailblazers—Dr. Mark Adams Talamini, president of the Society of American Gastrointestinal and Endoscopic Surgeons, and Dr. Santiago Horgan, chief of Minimally Invasive Surgery at the University of California San Diego Health System. Dr. Mintz returned to Israel in 2006, where he now has a growing number of laparoscopy-related patents to his name and is recognized in the field as an out-of-the-box surgical innovator.
Laparoscopy has only been around for 25 years, and it is improving all the time,” he says. “When initially practiced, surgeons peered into the abdomen through a laparoscopic cylinder. Today’s laparoscope is a thin, fiber-optic tube with a tiny video camera on the end that transmits high-resolution images of what is going on inside the body cavity to a high-definition screen. The first instruments used were longer and thinner versions of those for open surgery, but this was imperfect as the way of operating is entirely different. New instruments and devices are continually being developed so laparoscopy can be expanded and handle more complex procedures.”
During the past decade, Dr. Mintz and his team at the Innovative Surgery Center at Hadassah have created an efficient assembly-line system for inventing new laparoscopic devices and instruments. “We identify a need, or an individual or company approaches us with an idea,” says Dr. Mintz. “We find the right people, brainstorm it and begin its development with bench studies and simulations. Next we move to preclinical trials on animal models, after which we seek approvals for clinical studies from the United States Food and Drug Administration and Hadassah’s Internal Review Board. From there, we progress to prototypes. At some point during the two years this process usually takes we create a startup company or enter into a collaboration with industry and its greater resources.”
The Innovative Surgery Center has actively partnered with numerous companies in developing their new medical technologies. Fifteen-year-old Lumenis in Haifa, the world’s largest medical laser company, is one such collaboration. Working with Dr. Mintz’s lab on laser instruments for laparoscopy, the company has developed four cutters and coagulators to-date, each extending the reach of minimally invasive surgery. Dr. Mintz’s lab at Hadassah is currently working on a versatile laparoscopic surgical stapler with the two-year-old Tel Aviv-based company StepWise Biomed.
“We need a fast, accurate, uniform and nontraumatic way of reconnecting tissue severed in surgery in the intestine, colon and small bowel, so that its structure is preserved and it continues functioning,” says Dr. Mintz. “As such, we wanted to take an existing stapling and cutting mechanism and improve it, making the device significantly smaller than its predecessor, so it will cause less trauma when inserted and more accurate and secure closure. This is in active development.”
Another fruitful collaboration is with Given Imaging, the Israeli company founded in 1998 that developed the revolutionary “pill camera.” Swallowed, it transmits images of the small intestine as it journeys through the digestive system. However, it does not confirm the presence of blood. “We are working with Given Imaging on a method that will enable the PillCam to detect blood in the gastrointestinal system,” says Dr. Mintz. “It will be like a hemocult test done in the doctor’s office, but far more accurate because it is performed by the PillCam as it travels through the intestine.”
Hernia surgery is set to be eased by a laparoscopic tissue-repair kit, on which Dr. Mintz’s lab is collaborating with Easy-Lap Ltd., a private medical device company established in Kfar Truman in 2007. In some 90 percent of the three million hernias repaired in open surgery each year, the weakened abdominal wall is strengthened with a surgical mesh while it heals. With laparoscopic hernia repair, however, attaching the mesh can be problematic, for several reasons. First, laparoscopy instruments are designed to work in straight lines from where they are inserted—and because they do not articulate, attaching a mesh is a challenge. Second, the force with which doctors tack the mesh to the stomach wall must be carefully calculated. And, third, the tacks themselves, while initially strong, will dissolve within the three months it takes for new tissue growth to hold the mesh in place. F.D.A.-approved and on the market, the Easy-Lap kit comprises a flexible mesh placer that takes the webbing to the tissue repair site and a surgeon-friendly articulated mesh stitcher and tacker to fasten and attach it.
Virtual Ports Laparoscopy Systems, a nine-year-old medical device company in Caesarea, is collaborating with Dr. Mintz and other leading surgeons in Israel and the United States to reduce the number of incisions needed in laparoscopy, thereby improving patient outcomes. Traditionally in laparoscopy, two 5-millimeter incisions are made for instruments held in the surgeon’s left and right hands, and two 12-millimeter cuts for the camera and retractor.
“First, we considered the size of these incisions,” says Dr. Mintz. “Five millimeters, about the width of a slim pencil, was considered minimal because of the instruments used. So we thought, let’s take the instrument diameter down to two millimeters—the size of a thick needle—and that will minimize the chances of infection and bleeding. But a two-millimeter diameter resulted in instruments too flimsy to be effective.”
Dr. Mintz and his colleagues came up with an elegant solution: a single 20-millimeter incision—ideally in the navel, to prevent visible scarring—through which several instruments can be placed, adjacent to one another. A radical departure from the conventional four cuts, surgery through a single incision or port produces less postoperative pain, less blood loss, faster recovery time and better cosmetic results.
“Single-port surgery is, however, more complex, needs more expertise and training and better and more flexible instruments that can be angled inside the abdomen,” says Dr. Mintz. “The organ to be extracted—gall bladder, appendix, uterus—must be both clearly visible, distinguished from the overlying organs and soft tissue, and securely held as it is drawn up and removed through the navel.”
Partly based on work performed in Dr. Mintz’s lab, Virtual Ports has developed a proprietary technology called MicroAnchoring that uses exceptionally small devices to retract organs laparoscopically. MicroAnchoring enables surgeons to lift the organ targeted for extraction, anchor it to the abdominal wall and then withdraw the retractor and insert the cutter, so that only one incision is necessary.
And the flimsy instruments with outer sheaths of less than two millimeters? This is another laparoscopic hurdle that is about to be crossed. With startup Eon Surgical, Ltd., Dr. Mintz and his team have been developing microlaparoscopy—use of instruments with diameters of two millimeters. This cutting-edge research in the design of fiber-optic instruments was bought up together with Eon Surgical in 2013 for tens of millions of dollars by global medical devices giant Teleflex, Inc. Heralded as the new standard for diagnostic and therapeutic abdominal procedures, the first large clinical study of the technology is expected to begin this year.
“Improved instrumentation and improved technique modifications will enhance the possibilities of laparoscopy, and even open diseases such as diabetes to surgical solutions,” says Dr. Mintz. “We are progressing rapidly, but I believe we are still far from what we may ultimately achieve.”