Abstract
Background:
Minimally invasive surgery (MIS) using handheld articulating instruments (HAIs) has emerged as an innovative approach, offering enhanced dexterity and accessibility compared with conventional straight tools. There has been a significant surge in market interest surrounding HAIs. However, the question about the potential benefits of these devices for surgeons and patients in clinical applications remains unclear.
Methods:
We thoroughly searched relevant literature about the HAIs with clinical applications. This article reviews the feasibility, safety, outcomes, ergonomics, and learning curve associated with utilizing HAIs, including notable commercial products FlexDex, ArtiSential, and HandX. This study also investigates the comparisons of the use of HAIs with traditional laparoscopy and the da Vinci robotic system in terms of surgical outcomes and operational efficiency.
Results:
Early clinical studies demonstrate the applicability of HAIs across gastrointestinal, urologic, cardiothoracic, and general surgery, with promising results and few complications reported. Comparisons with conventional laparoscopy reveal no significant differences in surgical outcomes. However, HAIs present a more prolonged learning curve than robotic surgery for novice users. Combining three-dimensional visualization techniques facilitate performance. Further research with larger sample sizes is warranted to establish definitive superiority in surgical efficiency and characterize optimal training methodology.
Conclusions:
Overall, the maneuverability and lower cost of HAIs present new possibilities in MIS, potentially expanding accessibility for smaller health care organizations and benefiting more patients.
Introduction
Minimally invasive surgery (MIS) is associated with smaller incisions compared with open surgery, resulting in faster recovery and shorter hospital stays. Laparoscopic MIS, first introduced in 1983 for appendectomy, has become an essential part of surgery, widely used in fields such as urology and gynecology.1,2 However, conventional straight laparoscopic instruments (CLIs) have limitations such as restricted movement and poor ergonomics. Robotic techniques, such as the da Vinci Surgical System introduced in 2000, have been developed to overcome these limitations, providing higher precision, less blood loss, and fewer errors in deep narrow anatomical spaces. 3 Nevertheless, the high acquisition costs and highly specialized training have hindered their widespread use. 4
To address the functional and financial gaps between CLIs and robotic systems, solely handheld articulating instruments (HAIs) have been developed. Patrick L. Anderson et al. reviewed the surgeon interface and control mechanism of mechanical articulating instruments in 2016, including commercial and academic ones. 5 Since then, some reported products or prototypes, such as the Radius Surgical System and Intuition, failed to achieve widespread use or were delayed in commercialization due to the steep learning curve and control interface issues. 6 Rapid technological advancements have introduced several new commercial productions, such as FlexDex and ArtiSential, and received widespread attention. These HAIs feature wrist-like joints near the tip, allowing for a 360° wristed capability that combines the dexterity of robotic systems with greater accessibility. The surgeon's hand or wrist movements are transmitted to the instrument's tip, and unlike previous designs, such as the Radius Surgical System or Intuitool, the movement of the end of the device is synchronized with the direction of the operator's hand and wrist.7–9
Studies have explored the feasibility and outcome of implementing HAIs in clinical practice and the learning curve associated with its use. This article reviews the safety, feasibility, and medical value of using these innovative instruments.
Methods
A comprehensive search of PubMed and Web of Science databases was performed using the keywords, including “handheld,” “non-robotic,” “manual,” “mechanical,” and “articulating instruments,” “wrist instruments,” as well as specific product names to conduct a comprehensive search for articles published between January 2017 and May 2023. Duplicates were rigorously removed from the initial search results. Subsequently, the search results were filtered by reading the titles and abstracts to eliminate articulating surgical instruments mounted on robotic surgical systems and other irrelevant articles. Uncertainties were identified by reading the full text and discussing it with the second author.
Results
The search results for HAIs encompass notable commercial products, including FlexDex, ArtiSential, HandX, Kymerax, and several self-designed mechanisms.10–12 These devices can be categorized based on their movement control method, falling into two main classifications: purely mechanical control and hybrid control. For instance, FlexDex, ArtiSential, and surgical tools with elbow joints designed by Katherine E. Riojas et al., as well as the 7-degree-of-freedom instruments reported by Prabhat Kumar et al., facilitate the transmission of hand or wrist movements to the tip through transmission strips or pull-wire devices.13,14 On the other hand, HandX employs a combination of hand movements and electromechanical control to achieve 8 degrees of freedom, of which 4 degrees of freedom are controlled electromechanically. 15
FlexDex, HandX, and ArtiSential obtained Food and Drug Administration (FDA) approvals for commercial sale in 2017, 2018, and 2020, respectively. However, Kymerax, currently in the prototype design stage, and other self-designed handheld articulating devices are excluded from the subsequent discussion due to the need for clinical usage data. Table 1 presents a comprehensive overview of these commercial products compared with the da Vinci Surgical System and conventional straight instruments. HAIs offer a range of freedom of movement from 7 to 8, and two are equipped with force feedback capabilities. 10 Nonetheless, none of the existing HAIs incorporate antishake features akin to the da Vinci Surgical System, and the variety of tip types available is less extensive than the da Vinci. Regarding cost, HAIs are only a fraction of da Vinci robots but are slightly more expensive than CLIs.
Technical Information of da Vinci, Conventional Straight Laparoscopic Instruments, and Handheld Articulating Instruments
CLIs, conventional straight laparoscopic instruments; DOF, degrees of freedom; HAIs, handheld articulating instruments; NM, not mentioned.
Feasibility and application
HAIs stand apart from conventional instruments and robotic systems, showcasing distinct structural characteristics and control mechanisms. As these instruments have recently entered the market, research is imperative to ascertain the specific surgical domains wherein their application could realize optimal utilization. Current investigations predominantly consist of feasibility studies, ranging from case reports to larger-scale explorations.
In assessing the feasibility and applicability of handheld articulating devices, we directed attention toward reported application areas, surgical outcomes, and associated complications. Through a comprehensive analysis, we sought to elucidate these innovative instruments' potential benefits and limitations in clinical practice.
Gastrointestinal surgery
Procedures within gastrointestinal surgery, including lymph node dissection, lesion removal, and gastrointestinal anastomosis, demand considerable workspace and maneuvering dexterity. However, using conventional instruments in these operations is often constrained due to their inherent limitations. Consequently, introducing new HAIs has garnered significant attention, with gastrointestinal surgery at the forefront of exploration and implementation, as shown in Table 2.
Applications of Handheld Articulating Instruments in Gastrointestinal Surgery
RYGB, Roux-en-Y gastric bypass.
HAIs found their initial application in Nissen fundoplication reoperation procedures of the stomach, a surgical intervention primarily involving the fundus's grasping, folding, and suturing. Traditionally, conventional laparoscopic surgery has been the prevailing approach, and the da Vinci surgical robot was introduced for this procedure in 2001, while no standards have been established. 16 Handheld articulated instruments exhibit a degree of flexibility akin to the da Vinci robot, suggesting the potential facilitation of Nissen fundoplication operations.
The first HAI reported for use in Nissen fundoplication surgery was the FlexDex, and this was also the first documented clinical use of FlexDex. 10 In this case report, a 2-year-old patient weighing 10 kg underwent a Nissen fundoplication reoperation using the FlexDex Needle Driver, resulting in a successful discharge from the hospital on postoperative day 4, with no associated complication. The authors demonstrated that the multiple angles and maneuverability of HAIs notably improved suturing in confined surgical spaces. Furthermore, in a more extensive clinical study encompassing 10 cases of Nissen fundoplication reoperation, the FlexDex consistently exhibited favorable outcomes. 17 Subsequently, Van der et al. further expanded the scope of surgical maneuverability by employing FlexDex in conjunction with Nissen fundoplication combined with diaphragmatic hernia correction and laparoscopic Roux-en-Y gastric bypass (RYGB) procedures, involving 2 and 7 patients, respectively, all without complications. 18
HandX has also been employed in laparoscopic Nissen fundoplication case reports, revealing superior results in terms of intraoperative blood loss and complications. 19 These noteworthy findings underscore the promising potential of HAIs in gastrointestinal surgery.
HAIs have demonstrated dexterity advantages in Nissen fundoplication operations, inspiring surgeons to explore their applicability in various other surgical domains. FlexDex and ArtiSential have been used in laparoscopic RYGB, surgical treatment of gastric adenocarcinoma, and distal gastric resections, yielding promising clinical outcomes. These interventions exhibited limited complications, with no reported fatalities.18,20,21
In the realm of complex colorectal surgery, both Bibo and Maria independently validated the application of FlexDex in the intestinal anastomosis, demonstrating favorable results without associated complications. However, in the operation of the right hemicolectomy, 1 of the 2 patients developed a postoperative urinary tract infection, denoted as Clavien–Dindo grade1.17,22 Although the authors did not explicitly attribute the cause of the disease to the instrument's usage, it remains an aspect worth considering.17,18
Similarly, studies investigating the use of ArtiSential in colorectal surgery have indicated feasibility and potential benefits. Darwich successfully performed a low anterior rectal resection using ArtiSential, achieving a quality total rectal mesocolic resection with no anastomotic leakage. 23 The authors then included 73 patients with indications for colorectal surgery, including colorectal malignancy, complicated diverticular disease, and obstructed defecation syndrome. The overall complication rate of surgery with ArtiSential instruments was 10.7%, further reinforcing its promising prospects. 24
No complications were reported in the feasibility study of HAIs in Nissen fundoplication. This may be attributed to the complexity of the surgical procedure. In gastrointestinal surgery, the complication rate found with HAIs is limited, and no deaths were reported in any of the studies. This indicated that HAIs could be a viable and safe option in gastrointestinal surgery.
Urology
Urological surgery presents challenges such as confined operative spaces, multiangle operation, and meticulous dissection near essential blood vessels, with high complexity and demand for precision. This has made urology an early and successful arena for adopting the da Vinci robotic platform. 25 In contrast, reports on the application of HAIs in urologic procedures still need to be expanded, as summarized in Table 3.
Applications of Handheld Articulating Instruments in Urologic Surgery
HAIs, handheld articulating instruments.
The inaugural clinical case of the FlexDex system in Europe involved suturing and anastomosis during laparoscopic radical prostatectomy. The patient experienced no intraoperative complications and rapidly resumed feeding on postoperative day 1. 26 Partial nephrectomies utilizing FlexDex were implemented in 2 patients by Vigneswaran and Crivellaro, along with pediatric pyeloplasties by Gorgen et al. and Tiago Elias et al., all without adverse events.27–29 The HAIs utilized in these initial urologic cases were FlexDex products, all of which are case reports. HAIs mainly performed resections and sutures, involving fewer surgical procedures and less complexity than the da Vinci Surgical System. Nevertheless, these preliminary experiences demonstrate the feasibility of handheld platforms for delicate urologic procedures in confined anatomies. Further comparative studies are needed to delineate the advantages of these technologies over laparoscopy and robotics for common urologic operations.
Cardiothoracic surgery
In minimally invasive thoracic surgery, straight, rigid instruments have a limited range of motion in complex anatomy, increasing surgical risks such as bleeding. HAIs with controlled angular tips could reach more expansive anatomical areas. Jin et al. reported using ArtiSential for lobectomy, thymectomy, diaphragm plication, thoracoscopic thymectomy, and other surgical treatments without complications. 30 A study reported a complex surgery using ArtiSential in treating a patient of chromophobe renal cell cancer with a solitary retro rural lymph node metastasis, and the results demonstrated that the mobility of HAIs was helpful in such a restricted anatomic space. 31
Minimally invasive cardiac surgery using HAIs was performed by Alina Zubarevich et al. from South Korea. 32 They reported that minimally invasive mitral, aortic, and tricuspid valve procedures were performed using the ArtiSential; and closure of atrial septum defect and myxoma resection performed through right anterolateral thoracotomy. However, the article does not mention specific case information or postoperative status. More evidence is needed to demonstrate the feasibility of HAIs in cardiac surgery.
General and hepatobiliary surgery
Although laparoscopic techniques for total extraperitoneal hernia repair and transabdominal preperitoneal (TAPP) hernia repair have been widely adopted, certain aspects, such as mesh suture fixation and peritoneal flap closure in the narrower lower abdomen remain time consuming. In addressing this concern, Maria successfully performed four TAPP hernia repairs utilizing the FlexDex system, and notably, no complications were reported in these cases. 17 Furthermore, two retrospective studies were conducted, comparing the performance of TAPP surgeries using HandX versus conventional laparoscopic instruments and the da Vinci Surgical System. However, the primary focus of these articles was the learning curve, with no specific mention of complications in their analyses.15,33 A study performed a single-port laparoscopic appendectomy on an elderly patient, and the patient was discharged on the first postoperative day without complications. 34
Parente Giovanni's team reported the feasibility of HAIs in hepatobiliary surgery. Notably, they successfully separated the duodenum and the gallbladder within a confined workspace beneath the liver. 35
The literature reviewed presents compelling evidence of the potential applications and benefits of HAIs in various surgical procedures. However, expanding the research scope and further exploring the use of HAIs in a broader range of surgical interventions is essential. Additionally, comprehensive assessments of outcomes and potential complications are crucial in establishing the safety and efficacy of these innovative instruments in the context of minimally invasive surgical practices.
Current feasibility studies have focused on gastrointestinal and general surgery, with a few reports in urology and cardiothoracic surgery. There is no application of HAIs reported in gynecology, which is one of da Vinci's areas of expertise. FlexDex is the most reported HAIs in clinical practice, which may be related to its early introduction to the market. ArtiSential demonstrated effectiveness in gastrointestinal surgery, and HandX performed well in patch fixation. The point of HAIs for use in pediatric surgery can be promising despite the lack of targeted studies. The success of the Nissen fundoplication procedure in a 2-year-old patient and the pyeloplasty procedure in a 6-year-old patient with FlexDex indicated the advantages of HAIs in tight spaces.10,29 Of note, in one study, the HAI experienced intraoperative device failure, requiring the replacement of the straight instrument to continue the procedure, suggesting that HAIs need to improve reliability further.
Ergonomics
Surgeons usually experience work-related musculoskeletal discomfort or injuries as they carry out delicate hand operations in narrow spaces and must keep a static posture long. 36 Difficult-to-access locations and navigating challenging angles in suturing or knotting demand more effort to execute using straight conventional instruments. Articulated dexterity of HAIs enables the surgeon to perform complex operations with less effort than CLIs. The surgeons highly evaluated FlexDex in sutures and knots as it proved improved accessibility and ergonomics in gastrointestinal surgery. 17 In the comparative study of Criss, enhanced ergonomics with FlexDex was observed as both the novice and trainee groups experienced less shoulder strain, and the trainee group described less shoulder, back, and forearm strain, too. 37 However, there is still plenty of room for improvement compared with the da Vinci Surgical System, with which the mechanical structure can transfer the surgical movement with a bit of manipulation of wrist/hand control.
The ArtiSential surgeons reported less comfort than da Vinci Surgical System, especially in the operator's wrist. While in certain operative gestures, HAIs could provide better ergonomics. 38 One of the possible optimal approaches is to reduce the weight of HAIs to lower the strain on the wrist.
Comparison with CLIs and da Vinci system
Studies showed no difference in the complication rate using HAIs with CLIs, and short-term surgery results were similar. Lee et al. conducted a retrospective study that included 122 matched groups of laparoscopic gastrectomies and showed no significant differences between CLIs and ArtiSential regarding operative time, estimated blood loss, number of lymph nodes retrieved, and length of hospital stay. 21 Similar results were observed in another study comparing HandX and CLIs in TAPP repair surgery. However, the results of the above studies may be biased because the surgeons performing the procedure were proficient with CLIs, whereas they were newly trained with HAIs. Considering the learning curve, the performance of the new articulating instruments is expected to improve with experience.
Few researchers were involved in the clinical outcomes of the comparison with the da Vinci Surgical System, except Jong Keun Kim et al. reported no statistically significant difference in the total median blood loss and intraoperative complications in animal experiments. 38 Further studies should involve larger-scale subjects and longer following periods. In terms of surgical efficiency, HAIs are less efficient than da Vinci Surgical System. Lima et al. investigated the steps in TAPP repair operation in 27 cases using the HandX needle driver and 27 points using the da Vinci Surgical System by a single surgeon retrospectively. The results indicated that HandX took 2.2 and 3.6 minutes longer operative time in mesh fixation and peritoneal closure than the robotic system. 33 Jong Keun Kim et al. conducted comparations in renal surgery using porcine models, and the results showed no statistically significant difference in total median operative time between the ArtiSential group 66.0 (61.7–75.6) minutes and da Vinci Surgical System group 73.6 (64.6–88.8) minutes. 38 However, former experience and learning curve may affect the surgeons' performance.
Min et al. found that all steps in the suturing task showed no significant difference between the ArtiSential and da Vinci Surgical System when investigating surgeons with no experience in both HAIs and robotic systems. 39
The key results of the comparison studies are summarized in Table 4. Overall, there were no consistent conclusions comparing HAIs, CLIs, and da Vinci regarding surgical outcomes and efficiency. Surgeries or tasks should be carefully designed to objectively evaluate the efficiency of the three kinds of instruments, as detailed surgical procedures analysis showed that Robotic systems, CLIs, and HAIs presented preponderance in specific operational steps, respectively.10,17,38
Comparison of Handheld Articulating Instruments with Conventional Straight Laparoscopic Instruments, da Vinci
CLIs, conventional straight laparoscopic instruments; NR, not relevant; TAPP, transabdominal preperitoneal.
Learning curve
The angle of motion for the tip of HAIs is controlled through manual manipulation, and control operations are quite different from that of CLI or robotic systems. As such, surgeons must undergo a learning process and adapt their techniques accordingly. Understanding the learning curve will inform surgical teams about the necessary training and adaptation processes and contribute to successfully integrating HAIs into clinical practice. The learning efforts will significantly influence the surgeon's willingness to incorporate the product into their routine. Previous failures in introducing new products have demonstrated the learning curve as a critical aspect of market acceptance. 6 Table 5 shows an overview of studies investigating the learning curve of HAIs, as well as comparisons with CLIs and the da Vinci Surgical System.
Learning Curve of the Handheld Articulating Instruments and Comparison with Conventional Straight Laparoscopic Instruments, da Vinci Surgical System
2D, two-dimensional; 3D, three-dimensional; CLIs, conventional straight laparoscopic instruments.
However, it is essential to acknowledge that the learning curve may vary depending on each product's specific design and operational methods.
A particular focus has been placed on the learning curve of FlexDex, with notable findings indicating that it may need to be more user friendly for novices compared with conventional laparoscopic instruments. Novice users often require more effort to learn how to operate FlexDex effectively. 40 Furthermore, FlexDex presented a longer learning curve for novices when compared with robotic systems. 6 However, in a study performed by van der Vliet et al., the expert could perform safely and effectively employ FlexDex in clinical practice after just 10 hours of dry laboratory training, suggesting a limited learning curve for experienced surgeons. 18 The contrasting conclusions above may be attributed to differences in laparoscopic surgery experience or the difficulty level of assigned tasks. For instance, one study revealed that experienced trainees performed better with conventional instruments in easy lessons, while novice participants using the FlexDex device achieved higher accuracy, dexterity, and efficiency in challenging locations. 37
A similar phenomenon was observed in another study comparing the learning curves of ArtiSential among novice, intermediate experienced, and expert groups. The study found a more pronounced learning effect in the former two groups than in the expert group. 41 Additionally, Motahariasl et al. concluded from their comparison between three-dimensional (3D) and two-dimensional visual systems that combining 3D visual techniques with FlexDex led to better task performance. 42
Due to variations in experimental tasks and criteria for group division among the studies, it remains to be seen whether novices benefit more from HAIs and could improve their skills more than CLIs. Large-scale and multicenter investigations are deemed necessary to obtain a more comprehensive understanding of the learning curve of implementing novel instruments. Such studies will provide valuable insights into the optimal training approaches and support the successful integration of these innovative instruments into clinical practice.
Conclusion and Discussion
This article concisely overviews the validation results for recently marketed HAIs in surgery operations, comparative studies, and learning curves. HAIs are developed to enhance maneuverability, provide realistic force feedback, and meet surgeons' demands for flexibility. Current studies showed that HAIs have demonstrated their ability to suture and excise within confined spaces and provide a viable option for surgeons. While some HAIs are still in the research and development and design phase, more products are expected to be commercialized. Nevertheless, further research is needed to explore the performance and clinical outcome of HAIs application.
Although HAIs possess flexibility comparable to da Vinci Surgical System, a complete overlap with da Vinci regarding future advantageous applications is not evident. The reason is that HAIs still rely on manual operation, similar to traditional instruments, and cannot dampen hand tremors, which would limit the use of HAIs in procedures requiring exceptionally highprecision operations. However, the prohibitive acquisition cost of da Vinci poses challenges for many medical institutions in less developed regions, and patients in need of complex surgeries are compelled to seek other hospitals or take the risk of undergoing additional procedures. In contrast, HAIs hold the potential to provide 360° mobility at a lower cost, thereby alleviating the difficulty of performing complex surgeries and reducing the skill requirements for surgeons. In this manner, smaller and medium-sized health care organizations with limited budgets will have the capacity to perform complex surgeries that might otherwise be challenging before. Moreover, HAIs can offer a more economically viable option for patients.
To facilitate the integration of HAIs in small and medium-sized medical institutions, further studies should focus on elucidating the benefits of HAIs in terms of improved surgical outcomes. Such research will guide the strategic adoption of HAI products, enhancing health care accessibility and advancing surgical techniques.
Footnotes
Acknowledgment
This article has been approved by all authors and has not been submitted for publication elsewhere.
Authors' Contributions
R.M.: writing—original draft (lead); investigation (equal); formal analysis (lead); and conceptualization (supporting). L.G.: investigation (equal); and formal analysis (supporting). G.W.: Methodology (supporting); supervision (equal); and writing—review and editing (supporting). L.W.: Conceptualization (lead); Methodology (lead); writing—original draft (supporting); and writing—review and editing (equal).
Disclosure Statement
No competing financial interests exist.
Funding Information
The authors were supported by the grants from China association of medical equipment (CMOP-3-2023-8, CMOP-2-2023-7) and Sichuan Provincial People's Hospital (2022RK05).
