Periodic Reporting for period 2 - MEETMUSA (Accelerating the iMpact of microsurgEry by upscaling production of thE world’s first microsurgical roboT: MUSA)
Reporting period: 2023-01-01 to 2024-04-30
Complex microsurgical procedures such as reconstructive surgery after tumor resection, finger replantation after trauma, lymphatic surgery after mastectomy, or extracranial-intracranial bypass surgery to prevent subsequent stroke can only be performed by surgeons with microsurgical skills, since the structures to be sutured are well below 1 mm in diameter. Currently, it takes years of training to acquire the required extremely precise motor skills and even then, due to its complexity, treatment outcomes can be highly variable. Hence, there is a high demand for more access to standardized high-quality microsurgical treatments across all specialties in the clinic to give patients the highest standard of care.
The EIC supports the development and market introduction of Microsure technology. Microsure develops technology in the shape of robotic assistance enabling surgeons to perform these very complex microsurgical procedures with more precision, flexibility, ease and control, ultimately reducing the time to obtain expert skills and standardizing high-quality treatment outcomes. More specifically, Microsure is developing the next generation microsurgical robot: MUSA-3. The MEETMUSA project aims to accelerate introduction of MUSA-3 to the market so that you as a hospital, as a surgeon, or as a patient can benefit sooner from this state-of-the-art technology.
Plastic surgeons from Maastricht University Medical Center (MUMC+) started a collaboration with engineers from Technical University Eindhoven (TU/e) in 2011 to develop a surgical robot dedicated for open microsurgery. This collaboration resulted in a first prototype as part of a PhD project. In 2016, Microsure was founded as spin-off from the TU/e and further developed the prototype into a second-generation clinical prototype and obtained CE mark. Its unique feature is the human anatomy-based design in which the movements of the robotic arms provide similar dexterity as a human arm and the integrated gripper mechanism resembles the fingers and enables the use of existing microsurgical instruments. Although this MUSA-2 system was able to overcome Da Vinci’s limitations through its compatibility with microsurgical instruments and surgical microscopes, some usability aspects became limiting factors, besides issues with production, servicing and maintenance. The new MUSA-3 robot product will therefore include improved hardware, software and design to increase the usability, serviceability, and manufacturability, thus making it ready for commercial roll-out.
The EIC supports the development and market introduction of Microsure technology. Microsure develops technology in the shape of robotic assistance enabling surgeons to perform these very complex microsurgical procedures with more precision, flexibility, ease and control, ultimately reducing the time to obtain expert skills and standardizing high-quality treatment outcomes. More specifically, Microsure is developing the next generation microsurgical robot: MUSA-3. The MEETMUSA project aims to accelerate introduction of MUSA-3 to the market so that you as a hospital, as a surgeon, or as a patient can benefit sooner from this state-of-the-art technology.
Plastic surgeons from Maastricht University Medical Center (MUMC+) started a collaboration with engineers from Technical University Eindhoven (TU/e) in 2011 to develop a surgical robot dedicated for open microsurgery. This collaboration resulted in a first prototype as part of a PhD project. In 2016, Microsure was founded as spin-off from the TU/e and further developed the prototype into a second-generation clinical prototype and obtained CE mark. Its unique feature is the human anatomy-based design in which the movements of the robotic arms provide similar dexterity as a human arm and the integrated gripper mechanism resembles the fingers and enables the use of existing microsurgical instruments. Although this MUSA-2 system was able to overcome Da Vinci’s limitations through its compatibility with microsurgical instruments and surgical microscopes, some usability aspects became limiting factors, besides issues with production, servicing and maintenance. The new MUSA-3 robot product will therefore include improved hardware, software and design to increase the usability, serviceability, and manufacturability, thus making it ready for commercial roll-out.
The MEETMUSA project focused on upgrading the robotic arms of MUSA to address safety, dexterity and precision. User requirements were updated for MUSA-3 based on learnings from MUSA-2 and feedback collected over the years from surgeons. These user requirements were converted to new system requirements. Subsequently, new electronics, mechanics and software design specifications were drafted. Based on the new design specifications, suitable components were selected and have been tested in separate units accordingly. In addition, these units have been successfully integrated into a prototype of the robotic arm. These early prototypes were used in multiple user tests with groups of 2 to 15 surgeons and user feedback was incorporated in newer versions of the robotic arms. At the end of the design phase, verification tests on safety requirements and precision on the full robot arm were performed and the kinematic model of the arm was further optimized. Finally, surgeons and in-house experts validated the new robotic arms through simulated use studies in which an anastomosis was made on an artificial vessel.
In parallel, we worked on the redesign of a new software architecture for firmware and operational software. After designing the new architecture, software modules were successfully created for the embedded and operational software. With the software modules being integrated, we have realized a functional robot arm that can make high precision surgical movements. This required integrating our new electronics, mechanics and software design. These software modules are also integrated into the complete system such that the arms can be operated through the surgeon console.
Lastly, with regards to the production process, units were assembled to modules and assembly documentation on module level were finalized (e.g. work instructions and tooling for assembly and testing). A full production line is realized to produce the robotic arms and to integrate these into the complete system.
In parallel, we worked on the redesign of a new software architecture for firmware and operational software. After designing the new architecture, software modules were successfully created for the embedded and operational software. With the software modules being integrated, we have realized a functional robot arm that can make high precision surgical movements. This required integrating our new electronics, mechanics and software design. These software modules are also integrated into the complete system such that the arms can be operated through the surgeon console.
Lastly, with regards to the production process, units were assembled to modules and assembly documentation on module level were finalized (e.g. work instructions and tooling for assembly and testing). A full production line is realized to produce the robotic arms and to integrate these into the complete system.
The MUSA-3 robotic arms can reach surgical precision that is beyond the state of the art. Extreme surgical precision gives the surgeon more control during microsurgery, which would decrease the complexity of the surgical tasks and standardize a high-quality performance. Next to the precision, the improved robot arm design led to an increase of the dexterity or maneuverability of the arm, which has a direct impact on clinical performance. The robot arms can be positioned and moved in any orientation in relation to the microsurgical field which gives the surgeon multiple options in surgical planning. The surgeon is capable to make movements with the robot that are impossible to do with your own hands, such as infinitely rotating the wrist. Validation of the precision and dexterity of the robot arm by top surgeons in the field of microsurgery has shown where we stand in our development of creating the most precise surgical robot on the market. In addition, with the previous clinical prototype, we already observed a beneficial impact on posture and muscle tension, and subsequently this helps to prevent occupational health issues. As the posture of the surgeon that operates via the surgeon console has further improved in the new design, we are confident the ergonomics of the surgeon will improve further.
Furthermore, our robot is one of the few in the field of surgical robotics that makes use of existing, reliable microsurgical instruments. Our newly designed instrument adapter interface offers a versatile solution for surgeons as they are able to use any microsurgical instrument of their choice by simply attaching it to our robot arm using disposable instrument adapters. This increases the functionality of the robot and enables more treatment options for surgeons, opening up possibilities for treatments that have never been performed before.
During the development activities, novel and smart solutions related to the robot arm and instrument adapter interface have been filed as patents (IPR).
Furthermore, our robot is one of the few in the field of surgical robotics that makes use of existing, reliable microsurgical instruments. Our newly designed instrument adapter interface offers a versatile solution for surgeons as they are able to use any microsurgical instrument of their choice by simply attaching it to our robot arm using disposable instrument adapters. This increases the functionality of the robot and enables more treatment options for surgeons, opening up possibilities for treatments that have never been performed before.
During the development activities, novel and smart solutions related to the robot arm and instrument adapter interface have been filed as patents (IPR).