Periodic Reporting for period 1 - M.I.L.A.N.O. Robot (Transforming everyday surgery into a painless and scarless experience)
Reporting period: 2023-04-01 to 2024-03-31
Historically, in abdominal surgery (e.g. general, bariatric, gynecological, urological, colorectal) procedures were performed by accessing the surgical site via large incisions of 10-12 cm to allow surgeons to manipulate organs directly. This approach not only meant high internal trauma for patients, but also frequent (+50% of incidence) postoperative complications related to parietal cuts, leading to incisional hernias and infections. Patients needed, often, to undergo surgery a second time.
Thanks to the evolution brought by laparoscopy, there has been a shift from one large cut to multiple incisions of 1-3 cm. Surgical instruments underwent an important redesign: the size of the tools was reduced and surgeons started controlling instruments via handles placed at the opposite end of a 30 cm-shaft outside the abdominal cavity. Recovery time was reduced, however, surgeons had to adapt to 2D vision, limited movements and non ergonomic positions to reach surgical sites.
Due to the difficulties introduced by laparoscopy, robotics in surgery was acclaimed by surgical institutions as a high-potential tool to support surgeons in minimally invasive procedures. Robotics re-introduced 3D vision and enhanced dexterity in the small spaces of the abdominal cavity. However, its expansion and application remain limited, with less than 40% adoption rate in Europe in well-established procedures. Robotic surgery achieves high precision and stability, but still current surgical robots are expensive, not user friendly and large.
VALUEBIOTECH: ONE PRODUCT ALL SOLUTIONS
Valuebiotech is developing a portfolio of solutions called M.I.L.A.N.O. Robotic Platform (Minimally Invasive Light Automatic Natural Orifice), to empower surgeons with robots that can adapt to their own preferred surgical technique developed with years of experience.
The M.I.L.A.N.O. Robotic Platform is made of two typologies of medical devices: Assistive Robots and Operative Robots. Two product categories that are usually separate, are now integrated and can be used seamlessly, thereby allowing hospitals to cover all surgical approaches with the purchase of a single solution.
The first category covers robots meant to be used during mini-invasive surgical procedures called “hybrid” or “roboscopic”, during which surgeons operate in traditional laparoscopic approach but are assisted by robots for vision and exposition over the operating field. Assistive Robots’ tasks range from camera holding to tissue retracting to allow full exposition over the operating field and can be controlled manually or remotely by surgeons.
Operative Robots, used in fully robotic procedures, act instead as direct surrogate of the surgeon’s hands in all surgical tasks. In this case, surgeons control all robotic arms by sitting at a console positioned in the operatory room remotely from the operating room table.
Valuebiotech robots’ unique selling points:
• Assistive Robots are fully integrated into Operative robots, therefore with the purchase of one operative robot, both roboscopic and robotic procedures can be performed
• Operative robots can be used both in multi-port (surgical tools access the abdominal cavity via various incisions) and single-port configuration (surgical tools access the abdominal cavity via a single incision)
• Robotic Arms are multi-articulated: great intra-abdominal dexterity is reached and the robotic structure is therefore reduced in size, as little-to-no external movement is needed to position robotic arms intra-abdominally
• Robots are compact, Light and transportable: not requiring a dedicated Operatory Room
• Assistive Robots are controlled via hand controllers and voice-activated virtual assistant, allowing surgeons not to interrupt their manual operativity to control the robots
Thanks to the evolution brought by laparoscopy, there has been a shift from one large cut to multiple incisions of 1-3 cm. Surgical instruments underwent an important redesign: the size of the tools was reduced and surgeons started controlling instruments via handles placed at the opposite end of a 30 cm-shaft outside the abdominal cavity. Recovery time was reduced, however, surgeons had to adapt to 2D vision, limited movements and non ergonomic positions to reach surgical sites.
Due to the difficulties introduced by laparoscopy, robotics in surgery was acclaimed by surgical institutions as a high-potential tool to support surgeons in minimally invasive procedures. Robotics re-introduced 3D vision and enhanced dexterity in the small spaces of the abdominal cavity. However, its expansion and application remain limited, with less than 40% adoption rate in Europe in well-established procedures. Robotic surgery achieves high precision and stability, but still current surgical robots are expensive, not user friendly and large.
VALUEBIOTECH: ONE PRODUCT ALL SOLUTIONS
Valuebiotech is developing a portfolio of solutions called M.I.L.A.N.O. Robotic Platform (Minimally Invasive Light Automatic Natural Orifice), to empower surgeons with robots that can adapt to their own preferred surgical technique developed with years of experience.
The M.I.L.A.N.O. Robotic Platform is made of two typologies of medical devices: Assistive Robots and Operative Robots. Two product categories that are usually separate, are now integrated and can be used seamlessly, thereby allowing hospitals to cover all surgical approaches with the purchase of a single solution.
The first category covers robots meant to be used during mini-invasive surgical procedures called “hybrid” or “roboscopic”, during which surgeons operate in traditional laparoscopic approach but are assisted by robots for vision and exposition over the operating field. Assistive Robots’ tasks range from camera holding to tissue retracting to allow full exposition over the operating field and can be controlled manually or remotely by surgeons.
Operative Robots, used in fully robotic procedures, act instead as direct surrogate of the surgeon’s hands in all surgical tasks. In this case, surgeons control all robotic arms by sitting at a console positioned in the operatory room remotely from the operating room table.
Valuebiotech robots’ unique selling points:
• Assistive Robots are fully integrated into Operative robots, therefore with the purchase of one operative robot, both roboscopic and robotic procedures can be performed
• Operative robots can be used both in multi-port (surgical tools access the abdominal cavity via various incisions) and single-port configuration (surgical tools access the abdominal cavity via a single incision)
• Robotic Arms are multi-articulated: great intra-abdominal dexterity is reached and the robotic structure is therefore reduced in size, as little-to-no external movement is needed to position robotic arms intra-abdominally
• Robots are compact, Light and transportable: not requiring a dedicated Operatory Room
• Assistive Robots are controlled via hand controllers and voice-activated virtual assistant, allowing surgeons not to interrupt their manual operativity to control the robots
Main objective of the project is to finalize the development of Assistive and Camera Robot, a series of products that position themselves between laparoscopic surgery and robotic surgery, covering what is called roboscopic surgery and facilitating the adoption of robotic techniques in general. The main achievements during this first part of the project have been the following:
• Image acquisition device and camera cover: a 3d vision system embedded inside a miniaturized camera that is to be inserted in a camera disposable cover attached to the robotic arm.
• Control of the robots with virtual assistant interface: voice-activated virtual assistant software for camera robot control and positioning plus hand controllers for camera and assistive robots to allow the surgeon not to move the hands from laparoscopic instruments that are being held and control the robots.
• Medical 4.0 implementation infrastructure: cloud system infrastructure for safe data storage and safe product performance
• Development of multi-articulated robotic arm with high potential for production in sustainable materials.
• Low impact production and high reuse, recycle product life cycle. Initial robotic arm manufacturing batch materials selection (surgical steel and peek for plastic components). Besides, we have progressed on the manufacturing agreements and manufacturing network creation to support initial go-to-market phase.
As a result of these technical achievements, two new patents were presented during year 1, together with industrial design deposits. Moreover, the data management plan has been updated, involving top quality software development partners and legal advisors.
• Image acquisition device and camera cover: a 3d vision system embedded inside a miniaturized camera that is to be inserted in a camera disposable cover attached to the robotic arm.
• Control of the robots with virtual assistant interface: voice-activated virtual assistant software for camera robot control and positioning plus hand controllers for camera and assistive robots to allow the surgeon not to move the hands from laparoscopic instruments that are being held and control the robots.
• Medical 4.0 implementation infrastructure: cloud system infrastructure for safe data storage and safe product performance
• Development of multi-articulated robotic arm with high potential for production in sustainable materials.
• Low impact production and high reuse, recycle product life cycle. Initial robotic arm manufacturing batch materials selection (surgical steel and peek for plastic components). Besides, we have progressed on the manufacturing agreements and manufacturing network creation to support initial go-to-market phase.
As a result of these technical achievements, two new patents were presented during year 1, together with industrial design deposits. Moreover, the data management plan has been updated, involving top quality software development partners and legal advisors.
M.I.L.A.N.O. Robotic Platform will allow hospitals to cover all surgical approaches with the purchase of a single product and empower surgeons with a robot that can adapt to their own preferred surgical technique.
During the second part of the project (Year 2) we will finalize the development of Assistive and Camera Robot. Following areas will receive special focus:
• The predictive maintenance and support based on digital twin. Digital twin interface is currently under development and used as testing interface for functional and performance test of the robots.
• Certification activities to validate the assistive robot and obtain a CE mark.
• Development of the 4.0 training academy, followed by targeted communication and dissemination activities.
• Low impact production and life cycle: Consider possible different end of life of disposable components that does not involve incineration and assessment of the actual performance gain in future implementation of plastic components to substitute surgical steel.
During the second part of the project (Year 2) we will finalize the development of Assistive and Camera Robot. Following areas will receive special focus:
• The predictive maintenance and support based on digital twin. Digital twin interface is currently under development and used as testing interface for functional and performance test of the robots.
• Certification activities to validate the assistive robot and obtain a CE mark.
• Development of the 4.0 training academy, followed by targeted communication and dissemination activities.
• Low impact production and life cycle: Consider possible different end of life of disposable components that does not involve incineration and assessment of the actual performance gain in future implementation of plastic components to substitute surgical steel.