Medical Device Daily Contributing Writer

PHOENIX – Call it what you want, traditional laparoscopic surgery with its multiple ports has evolved into single port laparoscopic surgery, sometimes called SPA (Single Port Access), SILS (Single Incision Laparoscopic Surgery), and for the lay community it often is referred to as "belly button" surgery (see Table 1).

Regardless of what you call it, single-port laparoscopic surgery minimizes the number of incisions required for major operations by accessing the abdomen (usually through the umbilicus) through a single incision. This new approach relies on articulating and other novel instruments and access platforms and introduces new techniques to the conventional laparoscopic working environment. Up to 34 different types of single port procedures are gaining acceptance in the surgical community and are being driven by patient demand for improved cosmesis and the possibility of reduced post-operative pain.

At the recent annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES; Los Angeles) here, more than 1,000 surgeons attended hands-on courses and symposia to learn these new techniques and test-drive the instrumentation that enables these exciting new procedures.

The total laparoscopic industry is pegged at about $4 billion worldwide, with approximately $800,000 of that amount being spent on trocars, or ports for which the laparoscopic instruments gain access to the abdomen. By far the most exciting new breakthrough in abdominal access – single port or not – was that of SurgiQuest (Orange, Connecticut).

Other novel trocar systems designed specifically for single-port surgery are listed in Table 2.

SurgiQuest's AirSeal and AnchorPort platform offers a truly innovative abdominal entry system built on a proprietary technology that addresses many of the heretofore unavoidable problems associated with laparoscopic surgery, whether it is conventional multi-port or single port entry.

Fear of penetrating an underlying organ when making the initial entrance into the abdomen has plagued surgeons for years. The company's AnchorPort trocar is available in a bladeless optical tip that accommodates a 5 mm laparoscope within the clear tip obturator channel to provide surgeons excellent visualization during abdominal entry.

Another common complaint about the use of conventional trocars that employ internal gaskets and seals to maintain the pneumoperitoneum is the surgeons' inability to traverse the seals without smudging the scope as well as to consistently maintain proper insufflation within the abdominal cavity, particularly during suction irrigation or smoke evacuation.

The Airseal access port has no internal seals or gaskets, but instead has tiny CO2 internal jets that produce a pressure barrier within the cannula that is greater than the pressure of the inflated abdomen. This pressure barrier is dynamically monitored in real time to spontaneously balance, maintain and adjust the intra-abdominal pressure to the desired setting even when suction is being used.

This system filters and recycles CO₂ that causes the CO₂ to reach homeostatic body temperature and minimize scope fogging, along with constant smoke evacuation. SurgiQuest currently offers both, 5 mm and 2 mm to 12 mm bladeless, optical tip trocars for single incision surgery with multiple ports in the umbilicus or traditional multi-port surgery. The company is currently market testing a "trocarless" AirSeal 18 or 22mm "true" single port device to be launched later this year.

In January, SurgiQuest signed a development agreement with Intuitive Surgical (Sunnyvale, California) to research and develop the use of the Surgiquest system in conjunction with its surgical robot. To date, more than 300 procedures have been performed in 20 hospitals using the SurgiQuest system.

When working through a single port, the space both outside and inside the port is at a premium.

In a presentation titled "Tools on the Horizon: Deployable Instruments, Magnets, and Purpose-built Platforms," Daniel Scott, MD, associate professor of surgery at the University of Texas Southwestern Medical Center (Dallas), said, "Single Site Surgery has many limitations: head space, instrument conflicts, range of motion, visualization. There are current and developing solutions for these limitations such as articulating and/or longer instruments, specialized multi-instrument ports and trocars, deployable instruments that use magnetic anchoring guidance systems [MAGS], and even an in vivo robot that provides increased range of motion inside the abdomen."

He added, "There are also purpose-built platforms that have all-in-one tools inserted through one port that were originally designed for NOTES procedures but may be able to transfer into the single port environment." (See Table 3)

"The challenge with Belly Button surgery is with retraction," Homero Rivas, MD, also from University of Texas Southwestern Medical Center, said in his talk at the Advanced Laparoscopic Techniques Postgraduate Course.

Conventional laparoscopic surgery employs the use of hand-held retractors, each of which requires a dedicated port in the abdomen and additional auxiliary personnel for manipulating them.

Rivas explained various alternatives to the standard retractor approach including the use of a suture that enters and exits the abdomen in separate areas and passes through or around an organ to retract it in "puppeteering" style or by attaching intra-abdominal suture to the anterior abdominal wall to hold the organ out of the way.

"The use of percutaneous sutures for retraction begs the question of additional punctures and incisions," he said.

At what point is it no longer a single incision procedure?

A novel retractor for laparoscopic surgery and especially for single-port surgery where the ability to maneuver inside the abdomen is compromised, was developed by Virtual Ports (Richmond, Virginia), a venture-backed, Israeli-based company.

It launched its internally-anchored, hands-free retracting device, EndoGrab, which eliminates the need for a hand held retractor, during surgery, at this meeting.

The EndoGrab is introduced using a proprietary reusable applier and is attached to the organ requiring retraction and then to the internal abdominal wall, exposing the operative field. The introducer is then removed and the port is free for use by other instruments.

The disposable single use EndoGrab lists for $120 while the reusable applier cost $500. FDA-cleared via a 510(k), the company has used its device in 50 cases at five beta sites and is now ready for a controlled commercial launch of its products.

It is estimated that there about 4 million laparoscopic surgeries performed worldwide annually, and during each of those procedures the laparoscope is removed and cleaned 16 to 20 times; often due to fog, smoke or tissue build up on the lens.

To avoid removal of the entire scope, Virtual Ports also has developed Endoclear, a small fabric that the surgeon can temporarily attach inside the cavity and wipe off the lens without removing the laparoscope. The tiny "handkerchief" slips through a 10 mm sleeve using the same applicator as the Endograb and costs $80 – an amount easily recouped by saving the time to remove and clean the scope 15 times per procedure.

By far the biggest evolution in bariatric surgery seen at the conference was that of sleeve gastrectomy, a procedure originally slated as a precursor for gastric bypass in patients too heavy to survive the surgery; but recently becoming a primary surgery to lose weight without the follow-on surgery.

Gregg Jossart, MD, of Laparoscopic Associates of San Francisco, presented his experience performing single-stage sleeve gastrectomy on 500 patients who were followed for two years and found sleeve gastrectomy provided excess weight loss (EWL) equal to gastric bypass when performed on patients with BMI under 45.

Samar Mattat, MD, medical director of the Clarion Bariatric Center (Indianapolis), found similar results he shared in his presentation "Sleeve Gastrectomy – The Science Behind It."

Again, patients with lower BMI had better results. Those with BMI under 55 were able to reach a BMI down to 26 while those with BMI over 55 were only able to reduce their BMI down to 37. "Although leaks are a rare complication, it can be devastating if it happens," he said. "Sleeve gastrectomy as a primary procedure decreases operating room time, is easier to perform (over gastric bypass and lap band), has a similar EWL as gastric bypass, and is modifiable."