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"Tiny Patients, Big Strides: The Rise of Robotic Surgery in Pediatric Care"

Updated: Apr 11

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.


Versius Robot
Flex Robotic System

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:

  • Medtronic Hugo™ RAS

  • Cambridge Medical Robotics Versius®

  • Intuitive Surgical Da Vinci SP®

  • Medrobotics Corp. Flex Robotic System

  • Asensus Senhance® ALF-X

  • Meerecompany Inc. Revo-i™

  • Wego Micro Hand S


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



Hugo Robotic System

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:

  • Medicaroid Hinotori™

  • Avatera Medical Avatera®

  • Distalmotion Dexter

  • Moon Surgical Maestro

  • Virtual Incision MIRA


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:

  • Titan Medical Inc ENOS™

  • SS Innovation Mantra

  • Rob Surgical Systems S Bitrack System


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.



SSI Mantra Robotic System

A Diverse Landscape: Robotic Platform Designs


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


  • Modular Design with Independent Arms (5 Systems): Platforms like Medtronic Hugo RAS and Asensus Senhance ALF-X feature a modular design with independent arms, typically ranging from three to four, including the dedicated optical arm for visualization. This allows for greater flexibility and maneuverability within the operating field.

  • Multi-arm Architecture (5 Platforms): Several platforms, including Meerecompany Revo-i and Medicaroid Hinotori, employ a multi-arm architecture. Similar to the modular design, these systems have three to four arms, including the optical arm.

  • Single-Port Platforms with Flexible Arms (2 Systems): Intuitive Surgical's Da Vinci SP represents a unique approach with its single-port design. This platform utilizes three to four flexible arms, including the optical arm, for operating through a single incision.

  • Miniaturized Design for Single-Access Surgery (1 Platform): The Virtual Incision MIRA platform stands out with its miniaturized design. This innovative system allows for the insertion of two sterile arms and the optical components directly through a single incision, minimizing invasiveness.

  • Flexible Endoscope with Operating Arms (1 Platform): The Medrobotics Flex Robotic System offers a distinct approach. It functions as a flexible endoscope equipped with two integrated operating arms.

  • Laparoscopic Instrument Assistance System (1 System): Moon Surgical's Maestro platform deviates from the typical robotic surgical concept. It's designed to assist surgeons during laparoscopic procedures by providing support and positioning for laparoscopes and other laparoscopic instruments.

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:

  • Open Console (Majority - 64.3%): Most platforms, including Medtronic Hugo RAS and Asensus Senhance ALF-X, utilize an open console design. This setup allows surgeons a clear view of the operating field through a high-definition monitor positioned at a comfortable distance. One exception within this category is the Distalmotion Dexter system. While it has an open console, it doesn't have a dedicated viewing system. Instead, surgeons rely on a standard laparoscopic screen positioned within the sterile field.

  • Closed Console (Da Vinci-like Architecture - 2 Systems): Platforms like Intuitive Surgical's Da Vinci SP employ a closed console design similar to traditional Da Vinci systems. Surgeons view the operating field through a magnified, high-resolution display within the enclosed console.

  • Semi-open Console (2 Systems): The Avatera Medical Avatera and Medicaroid Hinotori platforms offer a compromise between open and closed consoles. This semi-open design provides surgeons with an immersive view through a dedicated viewer but avoids the bulkiness of a fully enclosed console, potentially reducing the feeling of isolation during surgery.

  • Direct Control Interface (1 System): The Medrobotics Flex Robotic System takes a unique approach. It forgoes a traditional console altogether. Instead, surgeons directly control the endoscope and two mechanical arms using an open, two-dimensional screen. This eliminates the complexity of electromechanical mediation.

  • Instrument Holder System (1 System): Moon Surgical's Maestro platform deviates from the concept of a surgeon console entirely. It functions primarily as a holder for laparoscopes and other laparoscopic instruments, offering surgeons improved control and positioning during laparoscopic procedures.

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:

  • Standard Laparoscopic Trocars (Majority: 7): Most platforms, including Medtronic Hugo RAS, Asensus Senhance ALF-X, and Cambridge Medical Robotics Versius, utilize familiar laparoscopic trocars to create access points for instruments.

  • Dedicated Trocar Systems (Several Platforms: 4): Several platforms, like Wego Micro Hand S and Medicaroid Hinotori, employ dedicated trocars designed specifically for their system, potentially offering improved ergonomics or functionality.

  • Single-Site Access with Da Vinci SP: The Intuitive Surgical Da Vinci SP utilizes a dedicated metallic trocar compatible with a disposable commercial single-site access system, minimizing the number of incisions needed.

  • Trocar-Free Access with Medrobotics Flex: The Medrobotics Flex Robotic System operates similarly to a colonoscope, eliminating the need for trocars altogether, offering a potentially less invasive approach.

Instrument Choices for Delicate Procedures


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

  • Wristed or Flexible Instruments (Most Systems): Most platforms, like Intuitive Surgical Da Vinci SP and Meerecompany Revo-i, offer wristed or flexible instruments for enhanced dexterity and maneuverability within the confined operating space.

  • Limited Wrist Articulation with Asensus Senhance (Optional): The Asensus Senhance ALF-X platform may be compatible with wristed instruments from specific brands like Radia, although this might not be universally available for all surgeons.

  • Specialty Instruments for Wego Micro Hand S: Some configurations of the Wego Micro Hand S system include a rigid, advanced ultrasonic dissector, potentially offering additional functionalities for specific procedures.

Reusability: Balancing Cost and Efficiency


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

  • Reusable Instruments (Dominant Approach): A significant number of platforms, including Intuitive Surgical Da Vinci SP and Meerecompany Revo-i, utilize reusable instruments after proper sterilization, offering a potentially cost-effective approach in the long run. One system, Virtual Incision MIRA, stands out for being entirely sterilizable and portable.

  • Partially Reusable with Medrobotics Flex: The Medrobotics Flex Robotic System employs a combination of reusable and disposable instruments, potentially offering a balance between cost and convenience.

  • Disposable Instruments (Some Systems): Platforms like Avatera Medical Avatera and Distalmotion Dexter rely solely on disposable instruments, simplifying instrument handling but potentially increasing overall surgical costs.

  • Mixed System with Medtronic Hugo RAS: Medtronic Hugo RAS uses a combination of sterilizable instruments and disposable tools for specific functions like needle driving and cutting, offering flexibility based on the surgical needs.

  • Laparoscopic Instrument Compatibility with Moon Surgical Maestro: Moon Surgical's Maestro platform doesn't have dedicated robotic instruments; instead, it allows surgeons to use standard laparoscopic instruments, leveraging their existing inventory.

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:

  • Advanced Ultrasonic Energy (Limited Availability): Only a select few platforms, including Asensus Senhance ALF-X and Meerecompany Revo-i, currently offer advanced ultrasonic energy capabilities, potentially offering benefits like improved tissue dissection and reduced blood loss.

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.

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