ErgoSuture
Heralding the Next-Generation of Surgical Performance

Advances in science and technology have dramatically increased human life expectancy in recent years. However, this longevity results in increased lifestyle diseases, such as obesity, cardiovascular disease, and diabetes. These conditions, which can lead to a lack of functional organs or tissue overgrowth, require surgical intervention to enhance patient health and outcomes. With the increase in demand for surgical care services, surgeons need ways to manage an increased workload without sacrificing care quality.

Laparoscopic surgery has transformed patient outcomes by leading to faster recovery times and reduced complication rates. The expertise and skills required to conduct laparoscopic surgeries, however, are substantial. For example, to become proficient in laparoscopic surgery such as sacrocolpopexy, it takes a trainee 30 procedures to achieve an operation time equivalent to that of the teacher. Laparoscopic suturing is a laborious and time-consuming process requiring surgeons to coordinate multiple steps with a great deal of concentration, mainly because, during minimally invasive surgery, surgeons have difficulty assessing depth and 3-D orientation place instruments. They also face many challenges, including limited visibility (visualization via a two-dimensional monitor), limited range of motion and haptic feedback, and the fact that the tool endpoints move in the opposite direction to the movement of the surgeon’s hands.

There are currently two main choices for the advanced minimally invasive surgeon—either standard, or “straight stick,” laparoscopic surgery or roboticassisted 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 workload for advanced procedures, especially those that involve suturing at difficult angles. Interestingly, there has been limited innovation in instrumentation since the inception of laparoscopic surgery.

As a surgeon with firsthand experience with these surgical challenges, Dr. Luis J. Almodovar believed there was a path to advance surgical care. Partnering with Claude C. Nogard, a veteran pharmaceutical strategy expert, Almodovar founded ErgoSuture to improve the suturing process. ErgoSuture’s upcoming product, the Drive’N Roll (D&R), is bound to become the new standard in medical suturing.

Developed by a surgeon for surgeons, D&R was designed by Almodovar to decrease needle handling time with a shorter learning curve and the ability to be used across all surgical platforms. ‘We aim to streamline the suturing process, minimize the surgeon’s efforts, and improve the overall user experience through our solutions,’ says Dr. Almodovar, inventor and co-founder of ErgoSuture.

Ease of Use—The Answer to Better Suturing

While technologies to aid surgeons during a procedure are very advanced, the available range of instruments for laparoscopic surgery today is limited.

We aim to streamline the suturing process, minimize the surgeon’s efforts, and improve the overall user experience through our solutions

The two main choices available to surgeons to conduct advanced minimally invasive surgery are standard, ‘straight stick’ laparoscopic surgery or roboticassisted surgery. While the first may be considered crude and outdated, the latter is costly and requires considerable training, impacting its uptake, especially in countries with lower healthcare budgets. While there have been efforts over the years to develop a more practical solution for precision laparoscopy, there remains an unmet need, especially around ease of use; that is where D&R will help fill a void. D&R uses a novel technique to address the significant challenges faced by laparoscopic surgeons.

The tip of the instrument is where the innovation rests. Instead of traditional flat grasping surfaces, two rollers hold the needle in place, which has the ability to push or pull the needle in any direction with the pull of a trigger. In practice, the insertion of rollers changes the relationship between the needle and the needle driver, de facto changing from a static relationship (requiring the surgeon to twerk his wrist to drive the needle) to a dynamic one. Combined with the human wrist’s natural motion, the rolling mechanism allows the needle to penetrate the tissue in any direction or orientation, similar to robotic surgery.

The other innovation is to adopt a modified in-line handle grip with a Castroviejo-type mechanism for opening and closing, which is very familiar to surgeons, hence, shortening the learning curve. The tool induces familiarity and ergonomics. As such, there is virtually no learning curve before use.

The instrument is non-disposable, has significantly more precision, and comes at a lower per-user cost than anything else with similar functionality in the market today. D&R has the potential to transform the field of laparoscopic surgery significantly.

From Needle Driver to Suturing Solution (System)

D&R can work with any off-the-shelf suture mounted on a (curved or not) needle and can be used with standard or barb wired sutures. However, when used with off-the-shelf needles, D&R can produce perpendicular and parallel plane suturing because current needles are optimized to be grasped between two flat tips. Providing robot-like maneuverability, enabling surgeons to place the needle at any angle they see fit, ErgoSuture is set to reimagine the needle. A new needle architecture was born, allowing the surgeon to suture at any angle as he sees fit during the procedure and preserving the surgeon’s field of vision at any step in the suturing process.

When combined, D&R and its proprietary needle can enable constant contact between the needle and the rollers along its arc of rotation, expanding its maneuverability.

One Key to Open Many Doors

D&R is designed to shorten the learning curve and mental workload associated with expert laparoscopic suturing and reduce healthcare costs by replacing some of the more expensive suturing equipment currently used. In cases where surgeons are not experts at laparoscopic suturing, they may prefer to conduct open surgery or use more expensive devices like robot-assisted surgical platforms, which might not always be available. D&R offers an alternative solution in those situations by empowering less experienced laparoscopists to suture better and faster while expanding experts’ range of maneuvers.

These include laparoscopic suturing on the abdominal wall or deep in the pelvis. Such procedures are often performed within a narrow working space and require the surgeon to take a problematic ergonomic approach. However, tacking instruments are expensive, and they are associated with complications such as bleeding and neuropathy. Surgical robots are routinely used to perform prostatectomy, proctectomy, and hysterectomy because of the practical limitations of “straight stick” laparoscopy. In both these settings, where robotic surgery is not available or feasible, D&R can give laparoscopic surgeons the ability to suture in the pelvis or the abdomen. It would also allow for a more cost-effective and safer approach to securing the mesh on the abdominal wall using a standard laparoscopic approach.

"Suturing remains a challenge to both experts and non-experts and can lead to severe consequences if not done properly. ErgoSuture™ designs solutions to improve needle handling, prevent potential tearing of tissues; and improve the end-user experience, regardless of their suturing proficiency level "

D&R is a versatile tool that can serve many roles that standard laparoscopic instruments cannot. If a stitch or a suture line is difficult to make, it is less efficient to use a surgical robot routinely for the few times that a surgeon needs it. D&R will act as an extra device in the surgeon’s tool set that does not have a high per-use cost or a learning curve associated with it while offer-ing the same functionality that the doctor requires.

The New Standard in Medical Suturing

Dr. D. Nepomnayshy—surgeon, member of ATLAS (Advanced Training in Laparoscopic Suturing), and scientific advisor—stated, “The Drive’N Roll will allow standard laparoscopic instrument ergonomics to be applied to a revolutionary mechanism that drives the needle at any angle with the use of a trigger. I am convinced that most surgeons that see the device and hold it will want one in their kit.” ErgoSuture is actively preparing to launch a transformative instrument that will enable surgeons to streamline minimally invasive surgery. Device manufacturers in robotic surgery or endoscopic surgery can also adopt this technology, allowing for break-throughs in cost and access. ErgoSuture also has plans to develop new surgical techniques to mitigate surgical challenges further.