What's New in Minimally Invasive Surgery

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Devices for single-incision laparoscopy were the highlight of the SAGES 2009 exhibit hall.


SILS. SPA. LESS. No one can agree on a name for it, but most of the surgeons and exhibitors I talked to on the show floor at SAGES this year seemed to agree that single-incision laparoscopy was the unofficial theme of the annual meeting. Many vendors showcased new products designed to help surgeons perform better in the confined space single-incision surgery requires. Here's a look at some of the newest and most innovative products and devices I saw in the exhibit hall in Phoenix.

A single incision
Single-incision laparoscopy involves making 1 small incision (about 2cm) in the navel area and inserting multiple instruments through a single deployment device. The benefits of this method, which leaves just 1 external scar that's obscured by the bellybutton, are largely cosmetic; there's no conclusive evidence to show that it's any safer or less painful for the patient. But surgeons are understandably excited about the prospect of offering their patients a virtually scar-free experience, and manufacturers are responding to that excitement with a host of new devices designed specifically for single-incision access. The first and most important piece of equipment you'll need to get started is a device that can accommodate multiple instruments inserted from a single entry site.

Covidien's SILS Port
Covidien's SILS Port can accommodate up to 3 5mm cannulas or 2 5mm cannulas and 1 12mm cannula for multiple instrument access through a single incision. The foam-like material stretches and retracts but keeps the incision site intact and maintains the pneumoperitoneum while enabling instrument exchanges, adjustments and maneuverability. The manufacturer declined to provide pricing information, but the total cost is comparable to what you'd pay for all the trocars you'd use in a traditional laparoscopic procedure.

Olympus's TriPort Access System
Olympus signed a deal with Irish medical device manufacturer Advanced Surgical Concepts late last year to become the sole distributor of ASC's full range of products for Laparo-Endoscopic Single-Site (LESS) surgery. The TriPort Access System provides access for instruments sized 5mm to 12mm through incisions ranging from 12mm to 25mm. Two instruments can fit through the larger port at once without leaking, says Olympus, allowing 3-instrument access to the abdomen (in addition to the scope) through 1 incision. It has a unique, self-adjusting retractor system, which consists of inner and outer rings that grip the incision and create a gas-tight seal to prevent leakage. If you need to remove a specimen, you can remove and replace the top of the port intraoperatively. The port also rotates on its main axis, letting you change the positioning of instruments mid-procedure without pulling them out of their channels. Olympus did not disclose pricing information for the TriPort.

Instruments for smaller spaces
One of the biggest challenges of performing laparoscopic surgery through a single incision is maneuvering multiple instruments at once in such a confined space without creating a "sword-fighting" effect or obscuring the operative field. With less freedom to move around outside the incision site, it becomes increasingly important for the instruments themselves to be able to bend and rotate at the tip once inserted into the abdomen.

Stryker's IDEAL EYES HD Articulating Laparoscope
The new IDEAL EYES HD Articulating Laparoscope, which deflects 100 degrees in all directions at the tip, is Stryker's answer to the challenge of visualizing the operative site in single-incision surgery. The simple design of the scope's control unit lets you toggle between rigid and flexible-tip camera images with a friction-assist brake that automatically locks the tip in place as you maneuver it around. Stryker's scope can capture images in high definition (1280 x 1024 or 720p format), but it's not as slender as Olympus's standard-definition, 5mm EndoEye deflectable-tip scope. Manufacturers keep promising a 5mm HD laparoscope is on the horizon, but so far none has been successful in designing an HD camera chip tiny enough to fit in a tip smaller than 10mm.

One issue with articulating scopes is the plastic casing that covers the flexible part of the tip, which tends to degrade over time and require repair. Karl Storz Endoscopy has a solution to this problem in the works: The camera chip in its 10mm EndoChameleon scope rotates within the tip — like the roving eye of a chameleon — while the end of the scope itself remains rigid. This design eliminates the need for the plastic casing while still giving surgeons the multi-directional view they need to operate through a single incision. The EndoChameleon was available for a test run at the Storz booth at SAGES, but isn't on the market yet.

New Tools for Natural Orifice Surgery

It may be moving at a slower pace than single-port laparoscopy, but natural orifice translumenal endoscopic surgery, or NOTES, was still a hot topic at SAGES. Karl Storz Endoscopy showed off its still-investigational Anubis NOTEScope in an impressive glass-case display on the show floor, and Ethicon Endo-Surgery presented positive results from 13 preliminary studies on its NOTES Toolbox, an investigational set of devices designed to overcome some of the challenges of performing natural orifice surgery using traditional endoscopic equipment. Ethicon has received FDA approval to study the safety of the devices in the NOTES Toolbox in human clinical trials.

"We need industry to give us better tools," says Eric Hungness, MD, of Chicago's Northwestern Memorial Hospital, one of Ethicon's 4 upcoming clinical trial sites. "The instruments designed for endoscopic procedures aren't capable of doing what we need them to do."

The challenges are similar to those experienced with single-port laparoscopy: The narrow channels through which surgical instruments are passed make it difficult for surgeons to achieve the triangulation they need to grasp and cut tissue effectively. Ethicon Endo-Surgery's devices are designed to help surgeons maneuver around the abdomen without obscuring their view as they work on the surgical site, says Dr. Hungness. For example, the Steerable Flex Trocar establishes a translumenal path of entry for endoscopic instruments into the peritoneal cavity and then helps the surgeon guide those instruments to their destination point. The instruments in the NOTES Toolbox feature articulating end-effectors, such as graspers, biopsy forceps and monopolar hook and needle knives, that can be manipulated independently of the endoscope to bend at a joint at the tip.

— Irene Tsikitas

Stryker's MiniLap line of minimally invasive instruments
In addition to its new articulating laparoscope, Stryker also unveiled its MiniLap line of "ultra minimally invasive instruments." These 2.3mm-diameter tools for the manipulation, retraction and grasping of tissue can be inserted percutaneously, eliminating the need to put another trocar in when additional instrumentation is required. Demonstrations at the Stryker booth showed that these instruments were strong and durable despite their small, slender size, suggesting they're hardier than similar instruments on the market, which can bend or become distorted when used on larger patients. At press time, Stryker said it was still working out the pricing details of the IDEAL EYES laparoscope and MiniLap instrument line, both of which were slated to debut in June.

Covidien's Duet TRS Reloads
Covidien already has an articulating stapler on the market, but has added a feature that many surgeons will welcome. Instead of having to load tissue reinforcement strips on the back table, Covidien's Duet TRS Reloads have the synthetic tissue reinforcement material preloaded onto the stapler cartridges. These strips, which in other models have to be loaded onto the stapler manually using glue or strings, can be tricky to apply correctly. Having them preloaded on the device saves a step and reduces the risk of loading mishaps that can eat up valuable OR minutes and supply costs. Ethicon Endo-Surgery was also showcasing its first articulating stapler at SAGES, but the company says it's still in development.

What's New in Surgical Imaging

Sony set up what it called an "HD Technology Bar" in the SAGES exhibit hall to showcase its new PMW-10MD camera system (1920 x 1080), UP-55MD/HD digital color printer and LMD-3250MD 32-inch display monitor (also 1920 x 1080) for medical applications. The PMW-10MD system includes a small, lightweight camera that can be mounted on a boom over the operating table or on a surgical microscope, as well as a built-in HD recorder that can capture still or video images. The system comes with an 8-gigabyte memory card that can record approximately 35 minutes of HD video. The camera runs between $14,900 (without lens) and $20,100 (with lens); the monitor's priced at $7,495; and the printer costs $6,228.

Stryker's taking HD technology to the next level with its new WiSe Wireless HD platform, which consists of a wireless 1080p flat-panel monitor and video transmitter. The potential benefit of a wireless video system is obvious: It cuts down on the number of cords clogging up your OR floors. Coded "token keys" secure the signals sent from the transmitter to the monitor while keeping them from interfering with other devices in the OR, says the company, which did not disclose pricing details.

NDS Surgical Imaging's RISE (Radiology Imaging for the Surgical Environment) software platform is designed to give surgeons in the OR quick, easy access to diagnostic images via a touchscreen interface similar to that of Apple's iPhone. Traditionally, if a surgeon wanted to view an X-ray image during a procedure, someone would have to hang the film on the wall or the surgeon would have to leave the sterile field to consult a PACS system tucked into a corner of the OR, then scrub back in to continue operating. RISE prevents the surgeon from having to interrupt the flow of the procedure to view diagnostic images by letting an assistant or tech instantly call up an image from PACS and display it alongside a live feed from intraoperative cameras on a sterile monitor that's directly in the surgeon's view. NDS declined to give a list price.

Absolute 3D Imaging was at SAGES with its LifeVision prototype, a display system designed to give endoscopic surgeons a more natural view of the operative field without having to wear 3D glasses, says Tom Huntley, the company's vice president of sales. The technology's still in development and Mr. Huntley says there's work to be done to improve the prototype. For example, the current technology requires a straight-on view in order to work; if the surgeon moves his head from side to side, he loses the stereoscopic effect.

— Irene Tsikitas

Hernia repair
Not everything at SAGES was about single-incision laparoscopy. There were also some interesting developments in the world of hernia repair:

  • Atrium Medical Corporation: C-QUR Lite.

A variation of the C-QUR Mesh that Atrium debuted last year, this polypropylene hernia mesh has a lighter version of the bioabsorbable, omega-3 fatty acid coating than its predecessor, making it more flexible and easier to fit through smaller trocars.

  • Davol-Bard: SorbaFix. This absorbable mesh fixation system is a new competitor to Covidien's AbsorbaTack, which was unveiled at last year's SAGES. The polylactide fasteners are fully absorbed by the body about 12 months after implantation and, at 6.7mm, are slightly longer than Absorba-Tack, so they're supposed to offer deeper tissue penetration. The real upside, however, is that you can purchase them in larger loads (30 in a load vs. 20 for AbsorbaTack), which makes them more cost-effective. The list price is $750 for a 30-count load; $500 for a 15-count load.
  • Nashville Surgical Instruments: Kumar T-Anchors. Surgeon Sabi Kumar, MD, designed these small, T-shaped anchors to eliminate the need for grasping and feeding sutures through the suture-passer during the trans-fascial suture fixation of mesh. A sterile pouch of T-anchors contains a needle, stylet and 8 T-anchors for the placement of 4 sutures, says Dr. Kumar. Pouches are priced at $47 or $470 for a box of 10.
  • W.L. Gore & Associates: Infinit Mesh & Bio-A Fistula Plug. The longer hernia mesh is in the body, the greater the opportunity for chronic foreign body reaction. Gore sought to minimize that risk and promote long-term, natural healing by structuring its new large-pore Infinit mesh with 100% monofilament PTFE instead of multifilament polyester fiber, which the company says is more likely to degrade in the body over time. Gore also introduced its new Bio-A Fistula Plug, a 100% synthetic, bioabsorbable plug for fistula repair that consists of a bundle of hollow tubes capped with a circular disk designed to anchor the plug in place. Gore declined to give pricing information on either product.

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