BB&T Contributing Editor
SAN FRANCISCO — The Society of Laparoendoscopic Surgeons (SLS; Miami) has somewhat more than 5,400 members, comprising general surgeons, gynecologists and urologists. Many of the exhibitors at the 16th annual SLS meeting here in early September featured innovative devices used in endoscopic and minimally invasive surgery that were recently launched or still under development.
A highlight of the program was the Innovation of the Year award ceremony recognizing products that have crossover applications in both general surgery and gynecology.
Genicon (Winter Park, Florida) introduced its 15 mm Genicon bladeless trocar and cannula system for facilitating the placement of a gastric band in a laparoscopic banding procedure. It accepts 5 mm and 10 mm 'scopes and its optical tip allows for visualization of the tissue layers upon entry into the abdominal cavity during bariatric procedures. The trocar has a beveled edge for easier entry and reduced tissue trauma. It requires little insertion force despite the lack of cutting blades.
Innovamed (Irvine, California) launched its Laprostop, a disposable plastic device that helps control trocar insertion depth and allows it to stay in place without repositioning. It is attached to a trocar and can be locked into place at any point along the cannula. It also can be sutured into place by using the suturing ports in the flange. The Laprostop was evaluated in 100 patients by laparoscopic surgeons in nine countries specializing in obstetrics and gynecology, gynecologic oncology and infertility.
Aragon Surgical (Palo Alto, California) launched LapCap, a pneumo-peritoneum creation assist device that represents a new category of laparoscopic-enabling products. It allows a laparoscopic surgeon to safely and rapidly pass a Veress needle for introducing carbon dioxide gas into the abdomen in order to create a pneumoperitoneum. The device is clear and dome-shaped with a central needle pass-through and a vacuum line port. It was successfully evaluated in 48 gynecologic patients.
Civco Medical Solutions (Kalona, Iowa) displayed the Laparostat, a laparoscopic instrument holder that can be configured to accommodate any laparoscopic setup, allowing a complete range of movement and a stable laparoscopic image. The product was launched earlier this year at the annual meeting of the American Urological Association (Lithicum, Maryland). It can be used in gynecologic, urologic, bariatric, thoracic and general surgeries.
Novare Surgical Systems (Cupertino, California) recently launched its series of RealHand high-dexterity, hand-held instruments for full range of motion in laparoscopic surgery. It represents a new device category for minimally invasive surgery and offers dynamic articulation with seven degrees of freedom of movement and tactile feedback.
The initially introduced instruments are graspers and dissectors and will be followed by scissors, a needle driver and cut and seal products. The patented devices employ a series of proximal and distal cables and links which allow for movement and control of the end of the instrument with a simple wrist action.
RealHand allows for the instrument tip to mirror all hand movements, providing robotic-like maneuverability without the need or cost of complex hardware. Novare also markets the Enclose II anastomotic-assist device that is designed to eliminate the need for partial clamping of the aorta during beating heart surgery.
A similar line of products is marketed by Cambridge Endoscopic Devices (Framingham, Massachusetts), which introduced its Autonomy Laparo-Angle fully articulating and handheld instruments in April at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. (Los Anbeles). These instruments are used to map the motion of the surgeon's hand, offering seven degrees of freedom to access difficult areas and for tip positioning and control. The needle holder, needle driver and scissors are currently available, with the L-Hook and Maryland dissector instruments to be introduced later this year.
Starion Instruments (Sunnyvale, California) received an innovation award from SLS for its TLS3 thermal ligating shears that simultaneously seals and divides vessels for tissue welding in open surgical and laparoscopic procedures. The product incorporates two resistive heating elements which heat tissue between the jaws of the device from both sides. resulting in improved hemostasis, lower peak tissue temperatures and faster sealing and cutting times.
Starion is collaborating with Novare (Cupertino, California) for development of the Thermaseal device that uses Novare's articulation feature and Starion's TLS sealing and cutting capabilities.
Laparoscopic hernia repair and mesh products
Lawrence Biskin, MD, reviewed laparoscopic hernia repair. He concluded that the laparoscopic repair of inguinal hernias by experienced hands has proven to be better than open repair with regard to post-operative pain, recurrences and overall recovery, although the added procedure time results in a monetary loss to the surgeon. He also reported that the ability to repair concomitant umbilical hernias and contralateral inguinal hernias is a tremendous advantage to the patient by adding only a few minutes to the operative procedure without a significant increase in recovery time.
Several new surgical mesh products were displayed at the conference.
Covidien (Norwalk, Connecticut) showed the Parietex composite mesh for hernia repair. It is the first dual-facing mesh, combining full cell rehabitation and a resorbable adhesion-prevention polyester film that is hydrophilic for better tissue encapsulation.
Minnesota Medical Development (Plymouth, Minnesota) featured its Rebound HRD (hernia repair device) that uses a highly elastic Nitinol frame on a polypropylene mesh.
It is designed for the laparoscopic repair of both inguinal and ventral hernias. The super-elastic Nitinol frame allows for the device to be folded and inserted laparoscopically. Once deployed, the device fully unfurls or "rebounds" to its original shape — ready for quick and easy placement over the hernia defect.
The Rebound HRD conforms to the anatomy while providing stability, eliminating the need for anchoring, which in turn, minimizes patient post-op discomfort and the risk of nerve/blood vessel injury. The Rebound HRD also may be placed via an open incisional approach. The product has just received FDA 510(k) clearance and will be marketed shortly.
Proxy Biomedical (Galway, Ireland, and Lexington, Massachusetts) displayed its new MotifMESH, a macroporous implant suitable for different types of fascial defects.
It combines the ingrowth characteristic and strength of large-pore monofilament polypropylene mesh with the reduced adhesion attributes of expanded PTFE into a high-performance implant of condenced polytetrafluoroethylene. It is transparent and provides improved tissue integration and fluid drainage. The company also markets the VitaMesh macroporous surgical mesh.
Laparoscopic surgery devices, equipment
Lexion Medical (St. Paul, Minnesota) markets the Insuflow gas-conditioning device for maintaining a balanced homeostatic environment within the peritoneal cavity by humidifying, warming and filtering carbon dioxide gas used to insufflate the peritoneum during laparoscopic surgery.
Its newest product is used for smoke elimination and toxins that are produced when using electrocautery in laparoscopic procedures. The male luer end of the device is connected to the trocar and the opposite end to wall suction.
Passive smoke evacuation products are sold by Pall (East Hills, New York) and by Stryker Endoscopy (San Jose, California), a division of Stryker (Kalamazoo, Michigan).
Buffalo Filter (Buffalo, New York) is a leading supplier of smoke evacuation systems, filters and supplies. It recently introduced LapEvac, the first disposable and battery-operated smoke evacuator for use in laparoscopic procedures. It operates as a closed-loop system once pressure is established and re-circulates gas in the peritoneal cavity through a filter to clear smoke.
Stryker Endoscopy was the first company to combine voice activation, infrared technology and high-definition video to give surgeons greater control and better patient outcomes.
Stryker displayed its latest surgical tower visualization system that employs a second generation high-definition 1188 HD 3-Chip camera with a Vision Elect HD flat panel monitor for increased resolution, increased clarity and more intuitive user controls. Also on display was its Wingman pneumatic-driven scope holding system that is designed to hold any 5 mm or 10 mm endoscope and camera.
In March, Stryker acquired Sightline Technologies (Haifa, Israel), a developer of flexible endoscopes for the gastrointestinal and other markets which provides improved insertion and sterilization during colonoscopy procedures. Stryker will soon begin shipping these products.
Medtronic (Minneapolis) presented a paper on the use of its U-Clip in lap banding during bariatric surgery. The U-Clip device simplifies suturing during tissue approximation by eliminating knot-tying with each individual placement. It originally was used in cardiac surgery, but its size has been increased and new indications are for its use in general surgery, as well as neuro and spinal surgeries.
Ethicon Endo-Surgery (Cincinnati) has developed the Endopath Dextrus minimally invasive access system that features a rapid-adjust iris seal design for use in hand-assisted laparoscopic surgery. It will compete against the GelPort from Applied Medical (Rancho Santa Margarita, California).
These products are used in procedures that are midway between open surgery and minimally invasive surgery. They enable unlimited hand and instrument exchanges without the loss of pneumoperitoneum. As a result, continuous visualization and access are maintained.
SurgRx (Redwood City, California) markets the EnSeal temperature-controlled, tissue-sealing technology, available with a 5 mm jaw and a 3 mm curved tip jaw. This system allows surgeons to seal and transect small to large vessels, large pedicles and tissue bundles to achieve surgical hemostasis in laparoscopic and open surgery.
SurgRx's smart electrode technology utilizes temperature-controlled radio frequency (RF) energy for tissue sealing, resulting in high seal strengths in vessels ranging from less than 1 mm to 7 mm in diameter. Vessels are sealed quickly without smoke, char and with minimal thermal damage to adjacent tissue. Two patented technologies used in this product are the I-Blade and the NanoPolar thermostats, from a PTC carbon-loaded polymer.
The company's newest product is the hand-activated TAPtronic handle, which eliminates the need for a footswitch. EnSeal instruments come in three shaft lengths (a fourth shaft length will soon be added) for use in general surgery, gynecology and urology.
EZC Medical (San Francisco) has developed Intubaid, a low-cost, high quality disposable fiberscope for intubation. It provides a shape-retaining malleable tube, a working channel and a camera head that emerges from within the tube itself enabling endotracheal visualization and intubation without the need for a laryngoscope.
Laparoscopy for gynecology
Ceana Nezhat, MD, reported that despite the preference for minimally invasive procedures, two out of three hysterectomies are performed abdominally. Over the past two decades, the overall rate of hysterectomies has remained stable while the number of laparoscopic-assisted vaginal hysterectomies has more than doubled. Also, more complicated hysterectomy procedures, such as advanced procedures in patients with malignancy and hysterectomies via robotics, are being explored laparoscopically.
New and improved instrumentation is emerging that will further decrease operating room time, reduce morbidity and patient recovery time, and advance minimally invasive hysterectomies.
Advances in radio frequency technology have resulted in devices with quick sealing of the uterine vessel and ligaments with very little tissue damage or charring. Cytyc Surgical, a division of Cytyc (Marlborough, Massachusetts), markets the NovaSure impedance controlled endometrial ablation system, a patented technology that treats excessive menstrual bleeding (menorrhagia) due to benign causes. The NovaSure System is a quick, simple, safe and complete procedure that averages only 90 seconds. The system is customized to the length and width of the uterus. It utilizes radiofrequency energy rather than hot water as used with other endometrial ablation systems.
Cytyc is in the process of being acquired by Hologic (Bedford , Massachusetts).
ConMed EndoSurgery (Utica, New York) displayed its new Vcare uterine manipulator/elevator for use in laparoscopically assisted vaginal hysterectomy. It has a double-cup system: the forward cup displaces the cervix away from the ureter, retracts the urinary bladder and defines the colpotomy incision, while the back cup prevents loss of pneumoperitoneum. A 10 cc inflatable balloon at the distal end is used to stabilize the manipulator tube within the uterine cavity.
The device was shown in a 400-patient clinical trial to reduce blood loss and operating room procedure time. The next-generation PermaClip multi-use reposable clip applier that is easier to load and will use ConMed's Tissue-Lock titanium clips is under development.
Robotics for future procedures
Future directions in laparoscopy surgery were presented by Dmitry Oleynikov, MD, co-director of education and training at the Center for Minimally Invasive and Computer Assisted Surgery at the Nebraska Medical Center (Omaha, Nebraska).
He predicted that the next generation of laparoscopic surgeons will use robotic tools to create incisionless operations, which will revolutionize how surgical procedures are performed over the next 10 to 20 years.
Drawbacks to the expanded use of robots are the high equipment cost, lack of tactile feedback for the surgeon, and increased prep time and training for the staff.
The endoscopic environment is much more challenging than the laparoscopic environment and will require additional mechanical augmentation to perform complex surgeries. These will include robots capable of operating by themselves in order to create better lighting, better camera stabilization and allow the surgeon to perform natural orifice operations.
Laparoscopy will continue to be utilized, but with fewer and smaller incisions. A single incision will be made through which multiple instruments will be inserted simultaneously enabling a combined laparoscopic and natural orifice procedure to be performed with almost no pain and with a much quicker recovery.
Howard Winfield, MD, director of laparoxcopy and minimally invasive surgery at the University of Iowa Hospital & Clinics (Iowa City, Iowa), provided an update on minimally invasive urologic surgery.
Almost all types of abdominal and pelvic urologic surgical procedures have been attempted laparoscopically and/or robotically over the past 15 years. Of these attempts, the procedures that have proven to be most successful are laparoscopic radical, simple and donor nephrectomy and laparoscopic adrenalectomy.
Robotically-assisted radical prostatectomy for prostatic carcinoma has gained a large following over the last five years and more than 50% of the radical prostatectomies performed in 2007 are expected to use robotic techniques. Comparative data suggest that radical retropubic prostatectomy performed robotically is as good as the open approach.
Laparoscopic procedures which have yet to be shown to be as good as open surgical procedures include partial nephrectomy, radical cystectomy and urinary diversion, ureterolysis for retroperitoneal fibrosis and retroperitoneal lymph node dissection for testis tumor.
Laparoscopic varix ligation for treatment of varicoceles and bladder neck suspension for female stress urinary incontinence appear to be inferior procedures or more invasive than microsurgical varix ligation and transvaginal bladder suspension.