The Drive’N RollTM is an innovative instrument for laparoscopic suturing, that uses a technique never before applied for this modality. It addresses significant challenges faced by laparoscopic surgeons and has the potential to significantly transform the field of laparoscopic surgery.
Laparoscopic surgery has transformed patient outcomes by leading to faster recovery times and reduced complication rates. However, the instrumentation used has evolved little (if at all) since the inception of Laparoscopic surgery. Currently, there are two main choices for the advanced minimally invasive surgeon – either standard or “straight stick” laparoscopic surgery or robotic assisted surgery.
Both achieve similar clinical results, but robotic surgery allows for wristed instrument motion, which significantly decreases the suturing muscle memory learning curve and mental work-load for advanced procedures, especially those that involve suturing at difficult angles. The disadvantage of the surgical robot is its high cost and significant required training for the surgeon and their team prior to adoption. This has detrimentally affected surgical robot market penetration especially in countries that have lower health care budgets than the U.S. There are other instruments that have attempted to address the difficulties of straight stick laparoscopic suturing and dissection. These other attempts include disposable wristed instruments that have failed to gain wide-spread adoption because of their cost and complexity.
Another option has been the Endostitchä, which has gained wide-spread adoption because of its ease of use. Endostitchä, however, is a disposable instrument that uses a completely different type of suturing technique (toggling a short straight needle back and forth).
This method is completely different than all other open and laparoscopic operations. As a result of this difference, surgeons are forced to learn a new technique limited to only that instrument. Further, because the Endostitch™ is a disposable item from a single manufacturer, (which may not be part of a purchasing agreement for a healthcare system) it has limited overall usefulness.
The Drive’N RollTM (D&R) addresses many of these issues in a completely novel way that has the potential to transform laparoscopic suturing. The key concept is that it moves the complexity of a human wrist to the tip of the instrument, by using rollers to drive the needle. In addition, because the instrument is non-disposable, it has significantly more precision and less per-use cost than anything else with similar functionality on the market today.
How the surgeon’s hand interacts with the instrument is extremely important. The D&R handpiece is familiar and ergonomic; there is essentially no learning curve prior to use. The D&R employs a modified in-line handle grip with a Castro type mechanism for opening and closing. This orientation can be used in either hand to drive the needle in any direction.
The tip of the instrument is where the key innovation rests. Instead of traditional flat grasping surfaces that hold the needle in place, there are two rollers that hold the needle in place but can also push or pull the needle in any direction with the pull of a trigger. When combined with the natural motion of the human wrist, the rolling mechanism allows the needle to penetrate tissue in any direction or orientation, similar to robotic surgery, and with much greater flexibility than the Endostitch™. The D&R works with any type of suture which is mounted on a curved needle, it can be used with standard or locking sutures like V-Lock™. Further, the D&R can be used with any off-the-shelf (curved) needle to produce perpendicular and parallel plane suturing. Use of ErgoSuture™ proprietary needles will allow the surgeon to drive the needle in all orientations as the surgeon sees fit.
There are many operations that require routine use of laparoscopic suturing (such as gastric bypass, hysterectomy or prostatectomy), and they are considered “advanced” laparoscopic cases. For the reasons noted above, some of these operations are performed robotically or with an Endostitch™. Those that are performed with straight stick laparoscopy achieve a cost savings in terms of equipment, but sacrifice increased mental workload, and a longer learning curve to achieve expertise. We feel that this represents the largest immediate impact D&R will shorten the learning curve and mental workload associated with expert laparoscopic suturing and will decrease health care costs by replacing the use of some of the more expensive suturing equipment currently in use.
In addition, laparoscopic suturing can be required in any laparoscopic operation, even those that are considered “basic,” such as appendectomy or cholecystectomy, when difficult or unusual circumstances arise. In those cases, when the surgeon is not an expert at laparoscopic suturing, they may decide to convert to open surgery or to use more expensive devices like surgical staplers, which can be inappropriate or difficult to use in those circumstances. The D&R would offer an alternative in those situations, and when paired with a locking suture, would allow even the most basic laparoscopist the ability to sew an enterotomy closed or control a bleeding vessel, allowing for safer and less costly surgical care.
There are some laparoscopic operations or “maneuvers” that even expert laparoscopic surgeons have a hard time preforming with “straight stick” laparoscopic instruments. These include laparoscopic suturing on the abdominal wall or deep in the pelvis. Suturing in the pelvis, with a narrow working space and difficult ergonomic approach, has been one of the main reasons that abdominal robotic surgery has achieved popularity with many surgeons. Prostatectomy, proctectomy and hysterectomy are examples of surgeries that are now routinely performed with a surgical robot when available. In settings where robotic surgery is not available or feasible, the D&R could facilitate laparoscopic surgeons’ ability to suture in the pelvis. This would lead to the dissemination of minimally invasive surgery for these procedures in places where robotic surgery is not feasible.
Finally, there is the issue of having the right tool for the job. For most expert laparoscopic surgeons, most situations are routinely handled with standard instrumentation. However, situations arise where there is a stitch or a suture line that is difficult to perform and requires an instrument that is not immediately available. It does not make sense to learn how to use a surgical robot routinely for the few times that a surgeon really needs it, nor would a surgeon opt to open an expensive disposable instrument for a couple of stitches that they are struggling to complete. So, surgeons are forced to adapt and muddle through to completion. Surgeons will be grateful to have an extra tool in their set that (a) does not have a significant “per use” cost associated with it, and (b) that does not require a learning curve to use effectively.
It is entirely plausible that having a transformative instrument such as the D&R in the hands of creative surgeons world-wide will transform minimally invasive surgery. New surgical techniques and approaches to problems may be developed. In addition, device manufacturers in robotic surgery or endoscopic surgery may adopt this technology, allowing for breakthroughs in cost and access.
As many major innovations show us, the first product may not resemble the final product, and involves many steps along the way. In that vein, the Drive’N Roll™ represents the first iteration of a device that has a future that cannot be fully predicted. The roller mechanism approach to suturing has never been attempted in the history of surgery and represents a completely different solution to an old problem. Even though the final evolution of this technology is hard to predict, it is important to recognize that a major innovation is happening in the field of laparoscopic surgery.