What I Saw at SAGES

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New products that may make a difference from the Society of American Gastrointestinal Endoscopic Surgeons


In the near future, several general surgery procedures are destined to become simpler, safer, less painful, more ergonomic and/or more convenient. We will find ourselves viewing endoscopic images in brand new ways. We will soon be hosting new types of procedures that can help patients in need. And almost for certain, high technology is in our futures, including robotic surgery and high-speed command and control systems for our ORs. Those are a few conclusions I reached after touring the exhibit hall at the 2003 Society of American Gastroenterological Surgeons meeting in Los Angeles. If you do general surgery but didn't get to attend, here's a report.

The sharper image
Many video endoscopy companies are hard at work trying to make image quality better and more consistent.

One interesting new technology is the Olympus EndoEye. Traditional rigid scopes employ delicate glass lenses to transmit the image at the tip of the scope back to the camera. Even minor trauma will damage these lenses, affecting image clarity and ultimately necessitating costly repairs. The EndoEye's camera chip is at the distal end of the endoscope body, right behind the lens, and it uses wire to transfer the signal back to the processor. Thus, the scope should be much more durable. Trauma to the EndoEye could still affect the fiber optics that carry light to the tip, but it shouldn't affect picture quality. The technique also enables Olympus to offer an EndoEye model with a "deflectable tip"; the tip can deflect in any direction, just as the tips of flexible endoscopes do.

EndoEye scopes come all in one piece: The camera chip, endoscope body, camera cable and light source cable are all permanently attached to each other, with the end of the cable branching off into two "tails," one for the light source and one linking the chip to the processor. There is no assembly required, and you can autoclave the whole thing.

If you do a lot of procedures for which only one scope is needed, the durability and autoclavibility of the $14,000 EndoEye is compelling. But for procedures where the surgeons frequently switch telescopes mid-procedure, the traditional cameras that allow mixing of scopes with different camera heads will still be necessary.

Another unique entry in the video endoscope category was a new system from Israel-based Vision-Sense. This system also employs a single-chip camera in the tip of the scope. Uniquely, though, this one produces a three-dimensional image. The idea is to give surgeons true depth perception to enable them to do better surgery.

A brief test drive with special glasses revealed three-dimensional images. The depth of field was impressive, but the images were not as crisp as other two-dimensional images I've seen. The company has marketed the system in Europe so far, but plans to begin selling it in the U.S. shortly. One potential problem: If you acquire this system, it appears you must replace every piece of equipment except your insufflator. It's also unclear whether the system would work with flat-panel displays; the display used CRT monitors.

JVC, a new entry, has a camera billed as the smallest and lightest high-definition camera for endoscopic procedures. The resolution is 4 million pixels; the company claims the camera produces twice as many scanning lines as a standard TV. The image was indeed impressive; the screen displayed minute water droplets on a red pepper. Unfortunately, the device is not autoclavable; it's compatible only with ETO, Steris and Sterrad. The price is around $12,000.

The Storz Aida DVD image-capture system is also noteworthy; it lets you burn images and video directly onto a DVD. DVDs can store five times the data that a CD can. A spokesperson said the system can store up to 2.5 hours of video on one DVD. The system can also print to a regular color printer rather than a dye laser printer, which may save money.

Devices that make procedures easier and/or better
One item that caught my eye was Inlet Medical's CloseSure procedure kit. This device resembles a cannula, but the lumen is small and angled rather than coaxial with the cannula. The surgeon pushes the suture through the hole on one side, withdraws the needle, twists the device 180 degrees, pushes the suture passer back through, grabs the suture, pulls it through and ties it off. The company says this allows fascia closure in less than 90 seconds and helps prevent port-site herniation. I've seen surgeons spend lots of OR time trying to close the fascia in a way that would prevent hernia; it appeared that this device could make it much easier. The device also works for tamponading bleeders and for tacking up hernia mesh, the company says.

Each kit includes a Carter-Thompson suture passer and two rigid, molded plastic pilot suturing guides, one for a 5-mm port site and one for a 10- to 12-mm port site. As surgeons often do not suture 5-mm wounds, the former may get used only for pediatric cases. The device can be used for multiple port sites on the same patient, but is otherwise labeled for single use only. The kit costs $95, or $475 for a box of five. The device could very well improve care and save OR minutes; still, frugal facilities like mine could more easily justify a reusable version.

I was quite impressed with the Kumar Pre-View Cholangiography device; it accomplishes the same goal as cystic duct cannulization - a time-consuming and often frustrating exercise - much more quickly and easily. The Kumar instrument is a laparoscopic atraumatic grasper with a sideport to accommodate a cholangiogram catheter with needle device. To use it, the surgeon clamps completely across the lower portion of the gallbladder just above Hartmann's pouch, then threads the catheter (which has an attached 19-ga. needle) through the side channel of the clamp and into the gallbladder below the clamp. After injecting dye through the catheter, it's possible to visualize the biliary anatomy. Once cholangiography is complete, it's possible to use the same catheter to aspirate the contents of the gallbladder for ease of removal. The clamp costs $650, the disposable catheters $29 apiece.

If you do laparoscopic Nissen fundoplication, you may be interested in Medovations' Innervision Transillumination system. Perforations of the esophagus and stomach occur in 2 percent of these cases. They occur in part because with pooled blood, it's difficult to identify the various anatomical landmarks, including the esophageal border and the left crus. This is particularly true for less-experienced surgeons. The Innervision device, a sort of high-tech Bougie calibration tube, may reduce complications. It combines a fiber-optic cable with a disposable silicone tip. Because the tip is lighted, the surgeon can see it during passage and avoid perforation with the Bougie. The light also helps illuminate the landmarks so that the surgeon can avoid perforation during dissection. The fiber-optic cables are $795; the tips are $53 apiece.

The System One Comprehensive Lap CBDE Kit from Taut provides a sensible approach to common bile duct stone extraction. The kit includes a titanium retrieval basket, a multipurpose balloon catheter, a percutaneous introducer, a guidewire and a high-pressure syringe. The kits are enclosed in a thoughtful reusable plastic organizer. It's possible to inflate the balloon catheter to 6 mm; the catheter has a working channel to allow flushing of smaller stones or debris. The retrieval basket rotates a full 360 degrees to make stone capture easier. Once the stone is in the basket, you can pull it straight through the catheter for removal.

A new tissue adhesive looks like it might be easier to use than other like products. Indermil, from U.S. Surgical, comes in a ready-to-use single-use applicator. There is no need for skin contact during application, so in theory this product may cause less trauma than competing adhesives. According to the product insert, only one application is needed, and the glue cures in a quick 30 seconds. If you have multiple skin closures, you can recap the applicator between uses. The substance can be stored at room temperature for four weeks, but for longer periods must be refrigerated. One disadvantage: Patients may not shower or bathe until at least 48 hours after application.

Ethicon has also improved Dermabond, the first such product on the market. A new high-viscosity version is said to minimize runoff and may be especially useful when closing wounds on the face, where aesthetics are important, and particularly near sensitive structures such as the eye.

Trocars
Safety
The surgeons in our facility occasionally use Baxter's Tisseal, a sealant made from human fibrinogen, for topical or laparoscopic hemostasis. One of the challenges is preparing the substance. Currently, you must mix the contents of two vials using exposed needles at the point of delivery to the sterile field. The Duploject Easy Prep, a new mixing device to be introduced this month, supports AORN standards and OSHA regulations for sharps safety. The design still incorporates needles and you still draw the solutions up in luer lock syringes, but the needles are contained in the vial rather than being exposed. Tisseal is good for hemostasis, applied laparoscopically or topically. It may be interesting to some that Baxter has also acquired the porcine-based Flo-Seal (which we occasionally use in sinus surgery) and has reached a distribution agreement with Angiotech and will soon distribute CoSeal, a purely synthetic hemostatic agent; the primary uses of this product are vascular, reconstruction, A/V shunts and aortic repair. One other footnote: You can obtain fibrin sealers with the same ingredients as Tisseal from Haemacure; the company calls this product Hemaseel.

New from Ethicon EndoSurgery is the Endo-Anchor, a laparoscopic anchor for mesh placement. The company says the device makes it easier to manipulate the mesh and accurately place the anchor. Because the anchor has a larger mesh coverage, it may hold the mesh more securely than traditional tacks. It also allows the surgeon to more easily see anchor placement. It also lies flush against the mesh. It should be available shortly.

New procedures
Inamed's BioEnterics Lap-Band System may offer a lower-risk way to treat morbidly obese patients and may even allow outpatient surgical treatment in selected patients. A spokesperson said only eight deaths in 100,000 cases have been reported, as compared to one in 200 for more traditional gastric stapling techniques. No rerouting of the digestive tract is necessary; all the tissue remains in place. The 60-minute procedure involves inserting a gastric balloon suction catheter via the esophagus to help form a pouch in the atrium of the stomach. Then, using laparoscopic instruments, the surgeon places a silicone elastomer band around the upper part of the stomach to create the pouch. Only minimal dissection is necessary to channel the band around the posterior portion of the stomach. The band is adjustable via tubing connected to a reservoir placed under the skin during surgery. You can adjust the size of the band by increasing or decreasing the amount of saline in the balloon. It works by minimizing the amount of material that the stomach can accept. Because weight loss happens more slowly, lifelong vitamin therapy may not be necessary. As with many new procedures, one problem is reimbursement; the kit costs $3,000, but many insurers still don't cover the procedure.

As many as one in 13 people suffer from fecal incontinence. A new treatment called Secca may offer relief for some. Patients who have failed conservative therapy like fiber and anti-diarrheal medications are candidates. The procedure involves placing the patient in the prone position, and then giving a pudendal or deep perianal block together with conscious sedation anesthesia. The surgeon then inserts the Secca handpiece to deliver radiofrequency energy via needle electrodes into the anal sphincter, creating submucosal thermal lesions. During the healing process, the tissue contracts, offering relief for the incontinence. The exact mechanism remains unknown. Controlled studies showed improvement in 60 to 80 percent of cases. Certain patients are not eligible, including those with anterior sphincter defect from childbirth. Possibly because the procedure is so new, reimbursement may again be an issue.

Ethicon's Procedure for Prolapse and Hemorrhoids may offer an alternative approach to surgical treatment of hemorrhoids. The device employs an anoscope, a purse string device and a circular stapler to move the prolapsed tissue into the canal and excise excess mucosa. All the action takes place above the dentate line, preserving the sphincter. The company says patients who undergo this procedure experience significantly less pain and quicker return to normal than those undergoing traditional hemorrhoidectomies. With experience, the procedure takes about 20 minutes, the company says. The procedure can be done under local, regional or general anesthetic. The company claims 200,000 such procedures have been completed. A spokesperson would not divulge the price of this disposable kit or reimbursement information.

While on the subject, Wilson-Cook's "ShortShot" is worth a mention. This disposable hemorrhoid ligator is preloaded with four rubber bands. Used in conjunction with an anoscope and suction, you place the pistol-shaped ShortShot over the internal hemorrhoid and pull the trigger.

Cutting and coagulation
Conmed clearly did its homework during the engineering of its sleek new System 5000 electrosurgery generator. It sports a lot of thoughtful features throughout the machine and cart. One was a proactive pad displacement display. If the grounding pad started to lose contact, the LED display alerts you to the change so that you can address the pad placement before it became hazardous. Any staffer who has run to find a universal adapter for the cautery machine will appreciate the system's built-in ReadiPlug Universal Accessory portal. It allows you to plug in a variety of accessories in one universal port without an adapter. The recessed portals are lighted so that they are easy to find even when the room is dimly lit. There are handy holders on the mobile pedestal for the footswitch, hand controls, grounding pads and the cords. There is a smoke evacuator integrated into the machine; it's extremely quiet and it activates with the ESU. The machine also features many energy selections to fit the surgeon's preferences.

In other news, the disposable Ethicon Harmonic Scalpel has a new competitor: the reusable, autoclavable Olympus Sonosurg. Like the Harmonic Scalpel, the Sonosurg uses ultrasonic energy to cut and coagulate tissue. Because of its reusable nature, the device saves some $200 per case when compared to the Harmonic Scalpel, according to Olympus. The product is easy to disassemble for cleaning and reassemble for use. The company also touts an automatically activated smoke/mist evacuator that enhances the view without interrupting the procedure; that's because it works in harmony with the insufflator.

Meanwhile, Ethicon has improved its Harmonic Scalpel. Surgeons can activate the device with a handswitch in addition to the foot control method, and the generator has new safety features.

Laparoscopic instruments
I liked the looks of the Single Puncture Mini-Operating Laparoscope from Richard Wolf; it could make diagnostic procedures even less invasive. This 5.5-mm scope offers an accessory port and light cable all attached to the scope, making additional puncture sites unnecessary. A neat accessory is a right-angle light-source cable. This could be used with any scope but it's particularly useful for this one because it moves the cord out of the way.

For bread-and-butter instruments, Mahe International may be worth a call. The company has German-made reusable laparoscopic instruments for economical prices. For example, an autoclavable laparoscope lists at $1,790; competing products list for more than $3,000. A spokesperson claimed the instruments were equal to or better than other brands and that Mahe actually serves as the original equipment manufacturer for some competitors. The Nashville company provides service and fields a nationwide non-dedicated sales force.

Surgical robots
Both Intuitive Surgical and Computer Motion had their well-publicized surgical robots at the meeting. For those who have yet to see these machines in action, the surgeon sits adjacent to the OR table behind a high-tech console viewing the patient via a digital feed with a three-dimensional magnified field. The field of view can be controlled with a footswitch at the console. The surgeon rests his or her arms on supports and manipulates controls at the console. Several feet away, robotic arms hold laparoscopic instruments inside the patient and mimic the surgeon's moves. The arm holding the camera responds to voice commands. The arms and instrumentation can enact all the motions of the human wrist, including up and down, in and out, side to side, rotation and pitch and yaw. A principal benefit is that surgeon movements are more exact, with less fatigue and tremor. The system also translates gross movements to micromovements to accommodate the needs of a procedure. While we watched, a surgeon demonstrating one system picked up and removed a single seed from a red pepper and manipulated and tied a suture. Such exactitude may be particularly useful in delicate procedures. The systems also allow a highly skilled surgeon at one site do a procedure at a more remote site over the Internet. A limiting factor is cost; both robots are priced at about $1 million. Computer Motion and Intuitive Surgical plan to merge. What this means remains to be seen.

Integrated ORs
Nearly every company that has traditionally specialized in endoscopic video equipment now also offers "integrated" OR systems that include equipment and anesthesia booms, flat panels, OR lights and cameras. The systems also all have centralized OR controls on touch-screens that allow you to choose what to display on the flat-panel screens, call up images from archives, change the settings on some instruments, adjust room lighting and even do teleconferencing. Most of the companies will serve as project managers for the installation, doing equipment planning, providing wiring diagrams and offering other services. The vendors tout their ability to design the OR and support and service the equipment. They also characterize the equipment as modular and upgradeable with changes in technology.

Although an in-depth investigation was not possible in my limited time-frame, each system had unique features. In addition to providing wiring diagrams, Karl Storz supplies a wall panel that contains the wiring needed for its system. The centralized controls from Conmed and Olympus appeared especially feature-rich. Richard Wolf's system featured an interesting twist: The system seemed to offer most of the same features as others, but all the equipment is contained on a cart, meaning major renovations to the physical plant might not be necessary.

I'm not sure if the integrated OR makers can integrate with existing equipment in your OR or whether you must replace everything. Still, facilities in highly competitive markets may wish to evaluate these new systems as a way to attract and keep surgeons and nurses.

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