By JOHN BROSKY
Medical Device Daily European Editor
PRAGUE, Czech Republic — The promise of scarless surgery has set off a new wave of innovation in minimally invasive surgery (MIS) as current devices prove inadequate for the demanding manipulations required.
At the annual congress of the European Association for Endoscopic Surgery (EAES) held here last week, the dominant manufacturers introduced broad programs for supporting clinical explorations of techniques to deliver on the promise.
In scientific sessions and on the exhibition floor Olympus Medical Systems (Tokyo) and Karl Storz (Tuttlingen, Germany) presented newly branded programs to consolidate device development in both laparoscopic and endoscopic surgeries.
Where these two surgical approaches to MIS have become increasingly blurred over the 20 years since closed surgical procedures began displacing traditional open surgeries in gastroenterology, scar-free surgery is widening the divide with laparoscopy lending itself more easily to single-port access (SPA) through the bellybutton and endoscopy proving to be the essential, though difficult, approach for natural orifice transluminal endoscopic surgery (NOTES).
The LESS (Laparo-Endoscopic Single-Site Surgery) program from Olympus and the S-Portal program from Karl Storz surf this widening divide by consolidating device development in both practice fields under a single brand.
Heike Baehr, who leads the endoscopy division of Karl Storz, told Medical Device Daily, "No one can say where this is going to go. Everyone is pursuing a feeling more than any strategy. We are following the surgeons' needs right now."
According to Andreas Quistorf, general manager for Olympus Surgical Endoscopy, "We believe LESS is the future of minimally invasive surgery, or rather, we share a vision that this is the future direction.
"It is pushing engineers to resolve new challenges, to create new opportunities, and the flexible tip scope is an example," he said.
"But there is not a forcing of this market," Quistorf said, adding, "There is still not a 'wow' factor for single-incision access; rather, there is a great deal of clinical caution."
Redesigning the flexible endoscope
The challenges of scarless surgery is reversing the trend in MIS toward ever thinner, more flexible instruments, with an emerging line of new endoscopes that are not only thicker to accommodate multiple working instruments, but in some cases semi-rigid.
Approaching a targeted organ from a single point of access removes the possibility of triangulating working instrument through multiple trocars placed in the patient's abdomen.
The current line of flexible endoscopes typically have two channels in addition to the scope for graspers, needles or cutting instrument but the action is limited to sliding these instrument forward and backward, and the strength over coaxial cabling is inadequate for firmly grasping, cutting and retracting tissue.
At EAES, Karl Storz introduced the Anubis, a 16 mm multifunctional NOTEScope designed to solve this difficulty with a distal tip shaped like a closed tulip for introduction to the surgical site.
Opening the flaps of the Anubis points two working channels outward creating opposable angles for the instruments such as graspers, a coagulation hook, and needle holders that emerge like tiny robot arms capable of deflection and rotation.
These instruments have been developed and tested by surgical teams at IRCAD (Institut de Recherche contre les Cancers de l'Appareil Digestif; Strasbourg, France) although Karl Storz cautions that "some challenges remain."
A rumor started during a pre-conference technology session that Olympus had abandoned development of its long-awaited endoscope for NOTES, the Endo-Samurai, had executives scurrying after surgeons from that session to assure them development is ongoing.
The go-to-market branding for the prototype R-Scope that Olympus demonstrated at previous European conferences (MDD, Oct. 24, 2008), Endo-Samurai was not displayed at EAES, though it was much-discussed.
The key feature of the device is a swing function for the two working channels on a standard Olympus Exera II endoscope. 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.
Surgeons discussed during scientific sessions the pros and cons of experiences with an expanding range of endoscopes under development by other manufacturers, such as the Direct Drive from Boston Scientific (Natick, Massachusetts) and the EndoSurgical Operating System (EOS) with the TransPort device from USGI Medical (San Clemente, California).
At this stage, the triangulation features are appreciated, but surgeons agree these devices are cumbersome and the controls at the handle are becoming so complex that robotic assistance will be required on future versions.
New laparoscopic instrument for SPA
While these NOTES endoscopes remain far upstream in development, both Olympus and Karl Storz are moving more aggressively with modified laparoscopic tools for SPA procedures, entering the abdomen through the umbilicus.
Executives from both companies agreed single-port devices will never supplant multiple trocars, which represents a $600 million annual business in the U.S. alone.
Yet both companies told MDD they believe SPA device over the next seven years could grow to as much as a 20% share of the total trocar market.
"Right now 60% of all cholecystemies are laparoscopic procedures," said Quistorf. "If we can convert this to SPA, then you can imagine the volumes."
Karl Storz displayed a new line of access ports and longer handle, curved instruments developed in cooperation with Sir Alfred Cuschieri, director of the Institute of Medical Science and Technology at the universities of Dundee and St Andrews and professor of surgery at the Scuola Superiore Di Studi Universitari E Di Perfezionamento Sant'Anna (Pisa, Italy).
The Dundee ENDOcone for single-port laparoscopic surgery is unique as a reusable SPA device, although Wilifried Beckmann, sales and marketing manager for the Karl Storz affiliate Medical Technical Promotion (Neuhausen, Germany), which specializes in single-use endoscopy products, told MDD his company is targeting release of a plastic disposable ENDOcone at Medica 2009 in Dusseldorf in November.
Where competing plastic SPA devices from Olympus or Covidien (Mansfield, Massachusetts) are pushed into a 15 mm incision in the umbilicus, the ENDOcone is screwed into place through a 35 mm incision, a corkscrew action that raises the linea alba, the tendinous ridge of the abdominal wall, thereby expanding the access for this funnel-like device.
The ENDOcone features seven different ports for the laparoscope and working instruments, and the multi-port bulkhead can be removed toward the end of the surgery to extract an organ such as the appendix or gall bladder.
Where single-use plastic SPA devices cost 350 ($490), the per-use cost of the ENDOcone is estimated at 80 ($112) depending on the sterilization processes at a given hospital.
Karl Storz also introduced the X-Cone, another reusable SPA device that features two edges similar to conventional surgical retractors that are inserted in a 25 mm incision in the umbilicus.
Bringing together the two sides of the vertically sliced cone in a scissor-like action, the entry incision is expanded atraumatically, providing a three-port access for a scope and two working instruments.
The range of Karl Storz S-Portal laparoscopic instruments share the same 5 mm shaft with coaxial cabling but are curved into various configurations according to the preferences of surgeons developing the prototypes.
These double curved configurations increase the operative space between the two hands of a surgeon to create triangulation while minimizing the SPA phenomena of "sword fighting" between instruments inserted in the same angle of approach.
Instrument clash is similar to trying to turn a steak on the grill using two forks with your wrists tied together, where curved instrument allow the wrists to be untied and work from different angles.
For surgical site visualization, the ENDOCAMeleon being demonstrated by Karl Storz is a novel laparoscope featuring a 120-degree rotation of the lens within the rigid shaft of the scope to expand the view of the surgical site.
At Olympus the LESS family of products presented at EAES included the TriPort developed by Advanced Surgical Concepts (ACS; Wicklow, Ireland) and a not-yet-released range of working instruments that also feature multiple-curved shafts and rotatable distal tips.
"If LESS procedures were only about specialized instrument, then you would have to ask how the current 5,000 cases have been done," said Quistorf. "They are using available laparoscopic instruments.
"We expect these procedures will be done faster, and perhaps safer, with new instruments, but these instruments do not change the procedure," he said.
The Olympus solution for enhanced visualization at the surgical site is the EndoEYE LTF with a novel four-way flexing distal tip.
"All existing tools can only be considered experimental and there is not one device with a CE mark being used in routine practice," said Gerhardt Buess, head of the department for minimally invasive surgery at the Universit tsklinikum T bingen, at the conclusion of a pre-conference session dedicated to updates on NOTES and SPA technologies.
A pioneer in the field, having developed tools and techniques over the past 25 years with Richard Wolf GmbH (Knittlingen, Germany) for transanal endoscopic microsurgery (TEM) that includes a preferred, if not prevalent, suturing technique for single-incision closure, Buess said a new set of longer, thinner TEM instruments are being tested that he expects will be available in one year.
"We are the only team in the world that can perform a complete rectal sigmoidal resection, and now with these longer instruments, we are coming up to the spleen," he told MDD.
Yet today's tools such as floppy, unstable endoscopes for NOTES and the under strength, rigid tools for laparoscopic SPA are simply inadequate, Buess said. "The original euphoria is now giving way to more complicated issues."
Published: June 25, 2009