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New Suturing Devices: How They Work in Practice
Can these products help surgeons save time in the OR?
Bill Meltzer
Publish Date: June 9, 2008   |  Tags:   Supply Management
Surgical residents spend hours perfecting their suturing technique, but it takes years until surgeons can perform this tricky maneuver with their eyes closed. A market has arisen for devices that may make this procedure even quicker, and in some cases, safer. In order for them to be effective however, surgeons must get used to their feel, and, in some cases, adjust their suturing style. How steep is the learning curve, and are the results worth the effort?

Opinions will vary. Not all surgeons are going to want to use them. Adrian Park, MD, FRCS, FACS, a laparoscopic surgeon based in Lexington, Ky., says the devices have their pros and cons: "It takes a very long time to become proficient in suturing, especially laparascopic suturing. It's easier to learn to suture with one of these devices. For that reason, there is a strong market for these types of devices and a lot of surgeons swear by them. There's also a learning curve involved in using the suturing devices, but it's a shorter learning curve. One of the most important adjustments is in getting used to working with a straight needle. But there a lot of surgeons who become very skilled at putting in and tying stitches with the devices."

He continues, "For the most part, I'm a purist. I know how to use the suturing devices like the Endo-Stitch, but, except in certain cases where it's tough to use a standard needle drivers and do traditional laparoscopic suturing, I prefer the old-fashioned way. I find that with the suturing devices, it's harder to get the stitch exactly into the position I want it. That's why the suture-assist devices, as a whole, are not good for use if you have to get control of a bleeding vessel. A second issue is cost. If you can suture traditionally, it's a lot cheaper than investing in one of these devices."

Outpatient Surgery spoke to surgeons who have used three of the suture-passing products that have been developed for both closing incisions and stitching organs and tissue during surgery. While it must be noted that, with one exception, the surgeons were directly referred to OSM by the manufacturers, their comments were candid and provide a good deal of insight into how the devices actually work in the OR.

Quik-Stitch (Par?)
The Quik Stitch system is designed to aid endoscopic surgeons in closing the surgical site after the procedure. The device does not make the stitch, rather, it ties the suture by applying pre-tied knots. The system is comprised of an applicator/needle driver and a grasper. After making the stitch, the surgeon passes the needle driver from the knot applicator through to the grasper, grasping the suture behind the needle. The surgeon presses a button on the applicator and a pre-tied knot is released from the suture spool. He then pulls the applicator back until a formed (but loose) knot is visible. The knot is then moved forward with the applicator and sealed off. Finally, the surgeon uses a pair of cutters to clip the secured suture. The process begins again with the next stitch.

Robert Sewell, MD, Bedford, Texas, is an endoscopic surgeon who has used the Quik Stitch system for a variety of laparoscopic procedures, but primarily for laparoscopic cholecystectomy and nissen fundoplications. Says Dr. Sewell: "In traditional suturing, when you place a needle with a suture attached to it into the abdomen, you end up with two free ends. You have to find a way to tie those ends together in a secure knot, usually either with an instrument tie on the inside of the site or a hand-tied knot on the outside, which you then push inside."

Dr. Sewell gives the Quik Stitch system high marks for innovation. "This wasn't the first laparoscopic suturing device out there, but it was the first one that made knots. It definitely simplifies the process once you get the technique down. Typically, it only takes about three to four sutures the first time using it to figure it out; after that, it's relatively simple. Then it's a matter of gaining an equal or superior comfort level to how you've always done it."

He continues, "Overall, the surgeon comfort level is pretty good. It's certainly takes a lot less experience to become comfortable with the Quik Stitch than it does to initially learn how to suture. The only real drawback to the Quik Stitch is it works with a straight needle. It originally had one with a curved needle, but it didn't really function well with the needle holder. You can make it work with a curved needle but it's a little cumbersome working with it. So, there is a bit of comfort adjustment to using the straight needle instead."

One of the major selling points of Quik Stitch and similar systems is the claim that they save OR time in every case, which ultimately saves money for the facility. Dr. Sewell notes that the Quik Stitch system has saved him a modest amount of time in procedures. "I've been doing laparascopic suturing for quite a long time, so I became proficient at the traditional techniques for suturing," he says. "I've timed myself with the Quik Stitch and doing the knots by hand and found that I was slightly faster with the Quik Stitch. But anecdotally, I know of some surgeons who have experienced a night-and-day difference time-wise between the two. Some surgeons are simply more proficient than others at tying knots. But even those who are good at knot-tying may prefer having it already done for them. I use the Quik Stitch a significant percentage of the time but there are still occasional situations when I find it just as easy to tie the knot myself."

According to Dr. Sewell, the non-disposable portions of the system (the instrument, the needleholder, and the spool-holder) cost in the neighborhood of $1,000, which is usually a reimbursable OR expense.

Endo-Stitch (Tyco/U.S. Surgical)
According to Dr. Park, the Endo-Stitch is the most widely used of the suturing systems. The Endo-Stitch is a 10-mm instrument that has two jaws, which grasp a straight needle, which pulls the suture through tissue. The surgeon can then manipulate the jaw to twist around the suture to either put in another suture (continuous suturing) or use it to tie a knot (interrupted suturing).

Dr. Park says, "One of the big issues to be aware of is that you are using a straight needle. For over a century, surgeons have been using a curved needle to drive through tissue. The curved needle is less traumatic to tissue and it allows you access to certain areas that you can't get to with the straight needle. No matter how good you get at using the straight needle with this, or any system, I don't know if it can be as fully effective."

However, Philip McCann, MD, Harrisburg, Pa., believes that the adjustment can be made. Dr. McCann, a laparoscopic surgeon, uses the Endo-Stitch on a daily basis. He says, "Even surgeons who are proficient at suturing often like this device. It is used in most types of minimally invasive surgery. I find that it offers a high degree of precision and it's fairly easy to master the technique of using it, although it differs from traditional suturing. I find that it saves time, especially when used in conjunction with laparoscopic suturing. Younger surgeons in particular often find it easier to learn to suture this way and even experienced surgeons can pick up a little time. There will still be times when you are working near heavily bleeding vessels when you want the curved needle, which means you are using the traditional needle driver, but the Endo-Stitch is useful in the vast majority of cases."

The SuturTek system, which is now in clinical trials, is designed to replicate how surgeons traditionally tie sutures by hand and help them do it much faster. While it's primarily designed for inpatient procedures that require large incisions, it may be appropriate for outpatient procedures such as plastics and laparoscopic hernia repair (10 mm repairs and larger). The company is currently working on a subcuticular closure device.

According to Bill Patridge, executive vice president of the company, the SuturTek does not work like any other suture-aiding device on the market, which typically use rods, jaws, or clamps. The device consists of a handle, which is trigger activated. On the front end of the handle a sterile, single use cartridge is attached. The cartridge contains a standard curved needle and standard sutures.

David Reed, MD, MPH, MBA, FASC, who is SuturTek's chief clinical officer, explains how the device works: "The surgeon places the stitch by rotating the needle 360 degrees toward his own hand. He then squeezes the handle twice to place each stitch. The first squeeze and release of the handle drives the needle in a 180-degree arc through the tissue. The second squeeze again drives the needle 180 degrees. The stitch is secured by squeezing the handle until the needle comes to a full stop."

The company claims that SuturTek system is a safer alternative to traditional suturing because the suturing needle is contained within a sterile, single-use cartridge during loading, handling, and unloading, making the chance of a needlestick nil.

The system is currently in clinical trials; the company plans to release it for mass distribution this spring. Says Dr. Reed, "[Using the device] is a little bit like handling a fishing reel but really, what you are doing with your hands is the same motion you have been along with traditional suturing, but you are making the stitches in about half the time."