Imagine a world where surgeons use miniature robotic assistants to perform complex procedures on children, minimizing scarring and recovery times. This isn't science fiction; it's the exciting reality of robotic surgery in pediatric care.

The word "robot" first entered our vocabulary in 1921, appearing in a Czech play titled "Rossum's Universal Robots." While the concept of robots captured imaginations early on, their application in medicine took time. It wasn't until 1985 that the first medical procedure utilizing a robot was performed, assisting surgeons in brain biopsies.

Fast forward to the year 2000, and the landscape of surgery shifted significantly. The US Food and Drug Administration (FDA) approved the Da Vinci Surgical System, developed by Intuitive Surgical. This marked a turning point, paving the way for wider adoption of robotic technology in operating rooms. Just one year later, history was made again with the first robotic prostatectomy being performed.

Breaking Barriers: 

The 2010s saw a surge in robotic surgery for pediatric urology. Procedures like pyeloplasty (correcting a blockage in the ureter) and pyelonephrotomy (removing kidney stones) became prime candidates for robotic assistance. This decade also witnessed the development of smaller, more adaptable robotic instruments specifically designed for pediatric applications.

Today, robotic-assisted surgery has become a well-established tool in the field of pediatric urology and pediatric surgery as a whole. Surgeons are leveraging this technology to offer minimally invasive approaches to a growing range of procedures, improving outcomes for young patients.

Our exploration of robotic surgery in pediatrics brings us to the technology itself. A web search reveals a diverse landscape, with at least fifteen distinct robotic platforms identified. Seven of these platforms have received authorization for clinical use within various healthcare systems.

These authorized platforms include:

It's important to note that clinical results for these platforms have been reported, highlighting their growing use and potential benefits in pediatric surgery.

While seven robotic platforms have secured authorization for clinical use in pediatrics, several others are on the horizon. Five such systems are currently authorized, but their use in pediatric surgery hasn't been documented in scientific literature yet.

These include:

Our exploration also revealed three additional surgical platforms in development. However, details regarding their clinical approval status or specific applications in pediatric surgery are currently unavailable. These platforms are:

Available information on the existing robotic platforms:

Clinically Adopted Platforms

Company

Product Name

Country

Regulatory Approvals

Marketing Information

(n. Procedures/Platform)

Medtronic

Hugo™ RAS

US

FDA: ongoing

CE-mark: general surgery; urology; gynecology

Australian TGA: urology; gynecology

Health Canada: general surgery

MHLW PMDA Japan: urology; gynecology

NR

Cambridge Medical Robotics

Versius®

England

CE-mark: general surgery; urology; gynecology; thoracic surgery

Australian TGA: general surgery; urology; gynecology

Anvisa Brazil: general surgery; urology; gynecology

Other countries: India; Pakistan; Egypt

10,000 procedures performed (March 2023) [114]

>100 installed platforms (November 2022) [115]

Intuitive Surgical

Da Vinci SP®

US

FDA: urology; transoral procedures

MHLW PMDA Japan: urology; gynecology; general surgery; thoracic surgery; transoral

MFDS Korea: urology; general surgery; gynecology; thoracic surgery; transoral

NMPA China: yes, not specified

121 installed platform (December 2022) [116]

A’design award winner 2019

Medrobotics Corp.

Flex® Robotic System

US

FDA: transoral; colorectal; general surgery; gynecology; thoracic surgery

CE-mark: colorectal

Australian TGA: colorectal

Bankrupt of the producing company

Asensus

(formerly TransEnterix)

Senhance® ALF-X

US

FDA: general surgery; gynecology. Pediatric surgery expected in 2023

CE-mark: general surgery; gynecology; pediatric surgery

MHLW PMDA Japan: urology; gynecology; general surgery; thoracic surgery

Roszdravnadzor—Russia: yes, not specified

Taiwan: yes, not specified

>10,000 procedures performed (February 2023)

>49 installed platforms between 2016 and 2022 [117]

Meerecompany Inc.

Revo-i™

South Korea

MFDS Korea: urology; gynecology; general surgery

NR

Wego

Micro Hand S

China

NMPA China: general surgery

Reddot award winner 2022

Platforms under Clinical Investigation

Company

Product Name

Country

Regulatory Approvals

Marketing Information

Medicaroid

Hinotori™

Japan

MHLW PMDA Japan: urology; gastrointestinal; gynecology

840 procedures (December 2022)

28 installed platforms (September 2022) [118]

Avatera Medical

Avatera

Germany

CE-mark: urology; gynecology

Fist clinical procedure in May 2022 [119]

Distalmotion

Dexter

Switzerland

CE-mark: general surgery; gynecology

4 installed platforms [120]

iF design award 2020

Moon Surgical

Maestro

US

FDA: laparoscopic procedures

CE-mark: laparoscopic procedures

30 procedures performed [121]

Virtual Incision

MIRA

US

FDA: completed IDE for bowel resections. De novo classification pathway ongoing

NR

Titan Medical Inc.

ENOS™ (formerly SPORT)

Canada

FDA: planned in 2023

CE-mark: planned in 2023/24

NR

SS Innovation

Mantra

India

FDA: planned in 2023

CE-mark: planned in 2023

Other countries: India

5 installed platforms

100 procedures performed [122]

Rob Surgical Systems S

Bitrack System

Spain

NR

First clinical trial ongoing [123]

US: United States; FDA: food and drug administration; CE: Conformité Europeenne; TGA: Therapeutic Goods Administration; MHLW PMDA: Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency; NR: not reported; MFDS: Ministry of Food and Drug Safety; NMPA: National Medical Products Administration; IDE: Investigational Device Exemption.

A Diverse Landscape: Robotic Platform Designs

The seven authorized robotic platforms for pediatric surgery showcase a variety of designs and functionalities:

This diversity in robotic platform designs highlights the ongoing advancements in minimally invasive surgery for pediatric patients. Each platform offers distinct advantages depending on the specific procedure and the surgeon's needs.

Summary of the overall characteristics of the robotic platforms.

Robotic Platform

Patient Cart Architecture

Console Architecture

Operative Arms No.

Trocars

Instruments

Instruments’ Reusability

Advanced Energy

Medtronic

Hugo™ RAS

Modular

Open

3

Commercial

Wristed

Reusables (some disposables)

NA

Cambridge Medical Robotics

Versius®

Modular

Open

3

Commercial

Wristed

Reusables

NA

Intuitive Surgical

Da Vinci SP®

Single port

Closed

3

Dedicated + commercial

Wristed

Reusables

NA

Medrobotics Corp.

Flex® Robotic System

Flexible system

/

2

/

Wristed

Disposables

NA

Asensus

Senhance® ALF-X

Modular

Open

3

Commercial

Rigid with a kit of wristed

Reusables

Ultrasonic (rigid)

Meerecompany Inc.

Revo-i™

Multiarm

Closed

3

Commercial

Wristed

Reusables

Ultrasonic (rigid)

Wego

Micro Hand S

Multiarm

Open

2

Dedicated

Wristed

Reusables

Ultrasonic (rigid)

Medicaroid

Hinotori™

Multiarm

Semi-open

3

Dedicated

Wristed

Reusables

NA

Avatera Medical

Avatera

Multiarm

Semi-open

3

NR

Wristed

Disposables

NA

Distalmotion

Dexter

Modular

Open (with laparoscopic screen)

2

Commercial

Wristed

Disposables

NA

Moon Surgical

Maestro

Multiport instrument holder

/

1

Commercial

/

/

NA

Virtual Incision

MIRA

Single port

Open

2

NR

Wristed

Reusables

NA

Titan Medical Inc.

ENOS™ (formerly SPORT)

Single port

Open

2

NR

Wristed

Reusables

NA

SS Innovation

Mantra

Modular

Open

3

Dedicated

Wristed

Reusables

NA

Rob Surgical Systems S

Bitrack System

Multiarm

Open

3

Commercial

Wristed

Disposables

NA

NR: not reported; NA: not available.

Surgeon Console:

Surgeon Interface: Viewing the Operating Field

The way surgeons interact with these robotic platforms varies across the different designs:

This variety in console designs caters to surgeon preferences and the specific requirements of minimally invasive pediatric surgery.

Accessing the Operating Field: Trocars and Instruments

The methods for accessing the surgical field differ across these robotic platforms:

Instrument Choices for Delicate Procedures

The type of instruments used also varies across platforms, catering to the needs of minimally invasive pediatric surgery:

Reusability: Balancing Cost and Efficiency

The reusability of instruments differs depending on the platform, impacting cost and efficiency considerations:

Advanced Energy Options: Beyond Basic Functions

While all platforms support basic monopolar and bipolar energy for tissue manipulation, advanced features like ultrasonic energy are limited:

Staplers and Advanced Energy Availability: A Work in Progress

It's important to note that a complete range of staplers or advanced energy options isn't yet available for all the platforms reviewed. As technology continues to evolve, we can expect these functionalities to become more widely adopted across the spectrum of robotic surgery platforms for pediatric applications.

The Rise of Robotic Surgery Across Surgical Specialties: 

The use of robotic technology is rapidly expanding in the field of paediatrics beyond its initial applications in urology and general paediatric surgery. Recent publications describe successful applications of novel robotic devices in a wide range of procedures, including hepatobiliary surgery, colorectal surgery, abdominal wall reconstruction, upper gastrointestinal surgery, endocrine surgery, and even breast surgery.

Early promise, unanswered questions: 

While these initial reports are encouraging, the overall evidence base remains modest. Most studies suggest the feasibility of performing these procedures robotically, with minimal technical limitations reported. Additionally, with several new platforms receiving regulatory approval, the Asian market is likely to fuel further development in this field.

Standardization and training hurdles: 

However, there are significant challenges to address before widespread adoption. Currently, there's no standardized international training curriculum or credentialing program for robotic paediatric surgery. This lack of standardization makes it difficult to assess surgical proficiency and hinders the transferability of skills between different robotic systems.

Looking ahead: 

Despite these challenges, the future of robotic paediatric surgery appears bright. Technological innovation is poised to continue at a rapid pace, offering exciting possibilities across a spectrum of surgical specialties. However, robust clinical studies are needed to fully evaluate the long-term benefits and cost-effectiveness of these new applications.

Credits:

Marchegiani F, Siragusa L, Zadoroznyj A, Laterza V, Mangana O, Schena CA, Ammendola M, Memeo R, Bianchi PP, Spinoglio G, Gavriilidis P, de'Angelis N. New Robotic Platforms in General Surgery: What's the Current Clinical Scenario? Medicina (Kaunas). 2023 Jul 7;59(7):1264. doi: 10.3390/medicina59071264. PMID: 37512075; PMCID: PMC10386395.