Computer and Robot Assisted Surgery (CRAS) is an area receiving broad attention worldwide because of its strong potential to achieve new levels of healthcare. In Europe, the robotics and cognitive science communities have been independently pursuing research in this field, making significant, but fragmented contributions. Furthermore, strong manufacturers of surgical instruments are present in Europe. The goal of EuRoSurge is to facilitate the development of new products and their integration into surgical robots endowed with cognitive capabilities, thus establishing the new field of Cognitive Robotic Surgery.
More specifically, this Coordination Action aims at developing a conceptual integration platform for CRAS research and manufacturing, based on the following actions:
- Identification of the key European players in surgical robotics, (both technological players, skilled end-users and EU funded projects);
- Identification of the key European players in cognitive sciences relevant to surgery;
- Creation of a glossary/ontology for cognitive surgical robotics;
- Specification of a reference architecture for cognitive surgical robotics;
- Formulation of procedures for validation of surgical robots and their modules;
- Identification of non-technical roadblocks, e.g. patents, ethical and legal aspects.
Policy Context
The Project European Robotic Surgery (EuRoSurge) is a Coordination and Support Action funded by the European Commission in the FP7-ICT-2011-7.
Description of target users and groups
There are multiple target groups in the Eurosurge project. In fact, the primary target consists of the European research laboratories that are carrying out research on robotic surgery and on cognitive aspects of surgery. There is a pool of about 100 laboratories in Europe that are, at various levels, involved in this area of research. Eurosurge has identified them and connected them informally through periodic reports and a web site.
The second target of the project is the community of manufacturers of medical devices suitable and/or usable in robotic interventions. This is a community much harder to reach, whose involvement in the project is only starting.
Finally, the last target of the project is the legislative and regulatory bodies, to whom we will present the finding of one of the project activities, aimed at identifying how different countries norm the surgical practice aided by robots and regulate the training of the medical personnel. This last point is key to patient safety, and raising the awareness of the regulatory bodies on this issue is one of the main objectives of Eurosurge.
Description of the way to implement the initiative
WP1 – Player identification and language definition
Identifying the robotics and cognitive science laboratories doing research in surgery and develop the methods to define a common lexicon, inclusive of taxonomy and ontology, including:
- Creating the structure and an implementation plan for the lexicon;
- Defining numerical data structures and symbolical attributes;
- Identifying ontological relationships between the concepts and the entities;
- Defining properties of implementations and (explicit or implicit) state machines, enabling model checking or other techniques that can improve/ensure dependability.
The major challenge is to make the process implementation independent, while keeping it attractive and accessible to all the researchers working in robotic surgery. More specifically defined technical terms should be put into a context by working out the typical abstractions needed for system design including Hardware Abstraction, Resource Abstraction, and Communication Abstraction. We will also define the data structures that represent the main low-level research-independent concepts. A novelty of our approach is to have all of the terms expressed as meta-level symbolic information, which will support both engineering development for robotic systems and embodied knowledge for cognition.
WP2 – Reference Architecture for Cognitive Surgical Robotics
This WP should:
- Define the points of variations, for upcoming changes at design-time, deployment-time, or run-time;
- Define invariants that are to hold during the lifetime of the architecture, to ensure properties such as dependability, safety, and predictability;
- Put implementation techniques and mechanisms into context such that implementations have the desired scalability and promote extra-functional properties such as testability, verifiability, and performance;
- Have well-defined meanings of objects and their relations, as well as the properties of components and their interconnections, that is valid for the application domain.
The combination of these items should support implementations tailored to specific applications.
WP3 – Validation Procedures and Benchmarks for Cognitive Surgical Robotics
The objective of this workpackage is to specify a portfolio of verification procedures suitable for cognitive surgical robotics and formulate their implementation strategy at three levels:
- Test cases and metrics for the assessment of specific methods, processes or robot related functions (synthetic benchmarks);
- Validation procedures, which aim at verifying that the integration of a component into a surgical robot does not affect the overall performance of the system and possibly will not alter the certification status of the original medical device;
- System benchmarks, which will measure the surgical robot performance for given test cases, given the addition of the component(s) validated by the procedures above.
WP4 – Identification of roadblocks for cognitive surgical robotics
The objective of this WP is to identify the main non-technical roadblocks to the introduction of cognitive robotic surgery to the market, and develop strategy and methodology to overcome them with targeted actions. In particular:
- Develop a database of patents related to surgical robotics in which patents are classified in terms of their applicability, and examine how the patent protection law can affect the development of this new technology;
- Analyze the current body of law relevant to civil liability with respect to “autonomous” machines and evaluate its impact on the commercialization of cognitive robotics technology;
- Examine the process of “informed consent” with respect to the use of experimental technology in medical practice and adapt it to the specific needs and characteristics of cognitive robotic surgery. The major challenge of this task is to address the issues above in a pan-European context, to make the WP findings relevant to all European Countries. We will examine in depth the situation in three major Countries (Italy, Germany and Spain), developing the analysis methodology that can be applied to all other Countries as well.
WP5 – Dissemination
This work package has the objective of performing the dissemination activities of the EuRoSurge project and of defining the exploitation strategy of the project results. This WP will promote the project results to broader audiences, with the aim of easing the development and adoption of surgical robots solutions in Europe. Dissemination of the project results will run in parallel to the coordination activities throughout the whole project time. Exploitation activities will be focused to the last months of the project, and beyond the project conclusion.
WP6 – Management
The purpose of this task is to provide the administrative services and establish the administrative processes necessary for an effective management of the consortium and to ensure smoothness and efficiency. In particular, this will include all necessary administrative, contractual and reporting activities.
Technology solution
The goal of developing an active cooperation among research laboratories involved in robotic surgery, has been addressed by Eurosurge in two specific ways: tackling the technology and the dissemination aspects of the problem.
Cooperation among laboratories is hindered by the lack of common development platforms, including definition specification, software and hardware standard development paths and integration and validation processes. Since a Coordination Action has limited resources to develop novel technologies, focus was placed on a small case study that demonstrates the general approach to the development of high-risk, high-safety applications as in the case of robotic surgery. The case study focuses on needle insertion, a surgical procedure common to a variety of fields from neurosurgery to urology. For this procedure the responsible have developed the relevant ontology and used it to design a software architecture that patterns the semantic connections among the terms in the ontology. Furthermore, to add increased safety to the approach, they have also developed procedures to quantify the performance of the nominal configuration, by specific benchmarks, and to verify system performance should a component be changed due to failure. Although quite small, this test case has allowed us to develop some significant extensions to the component-based OROCOS software library, which is the standard, at least in Europe, for the development of real time robotic systems. These extensions are based on the inclusion on the OROCOS components of a controller that is monitoring the status of each component and performing an internal safety check during operation.
Dissemination of research results is one of the key elements of European projects, but there is no specific dissemination channel dedicated to robotic surgery. For this reason Surgipedia, a web site dedicated to the publication of results and high quality papers in robotic surgery, was developed. Surgipedia is link to the Eurosurge web site and includes also a tool for searching and categorizing patents related to robotic surgery. The project responsible figured that the rapid presentation of research results and the development of a patent tool search were the two top priorities of the dissemination activities of Eurosurge, and they are making these two tools available to the community. We are also in the process of identifying ways that would ensure the self-sustainibility of Surgipedia, once the Eurosurge project is finished.
Main results, benefits and impacts
Computer and Robot Assisted Surgery (CRAS) is an area receiving broad attention world wide, because of its strong potential to achieve new levels of healthcare. In Europe, the robotics and the cognitive science communities have been independently pursuing research in this field, making significant, but fragmented contributions. Furthermore, strong manufacturers of surgical instruments are present in Europe. Thus, the objective of this project is to develop an integration methodology for the efforts of all research and manufacturing players in CRAS. The goal of this methodology is to facilitate the development of new products and their integration into surgical robots endowed with cognitive capabilities, thus establishing the new field of Cognitive Robotic Surgery.
The EuRoSurge project has developed a conceptual framework that simplifies communication among the surgical, engineering and manufacturing communities by defining an ontology of the selected surgical process; it facilitate the integration of results of research and development into complex systems thanks to a standard structure based on software components; it simplifies technology transfer from research to products by embedding validation methods into the software component and defining specific benchmarks. EuRoSurge has developed a framework for continued and effective cooperation among research laboratories and manufacturers, and the developed instruments will facilitate the integration of research from different European Laboratories.
EuRoSurge has achieved the following goals:
- Identified all the research laboratories and companies active CRAS;
- Developed a map of the current activities in CRAS in Europe;
- Defined a common language and an ontology to specify a surgical process;
- Defined a modular software component-based architecture for ease of integration;
- Defined performance validation and compatibility tests of the software components;
- Developed an instrument for quickly accessing and categorizing patents;
- Examined legislations in four European Countries to identify differences and incongruences;
- Organised a number of workshops and meeting to foster the creation of the CRAS community.
Track record of sharing
The Eurosurge project put a lot of efforts in organizing and participating to workshops in CRAS, to gather information from the community among the main difficulties of this area and to disseminate the project results. In particular, Eurosurge has been the main organizer and/or partner in the workshops on CRAS at the following events:
- European Robotics Forum 2012: A roadmap towards a European Network of CRAS;
- European Robotics Forum 2013: Technology transfer and innovation;
- IEEE International Conference on Robotics and Automation 2012: Modular surgical Robotics;
- IEEE International Conference on Intelligent Robotic Systems: 2012 EU funding opportunities;
- ES-GC2 2013: The advancement of medical devices;
- IEEE International Conference on Robotics and Automation 2013: Surgical Robotics;
- Hamlyn Symposium on Robotic Surgery 2013: Safety in robotic surgery;
- Software Technologies, Applications and Foundations 2013: Cyber physical systems
The other venue for result dissemination is the project web page:
and the associated Robotic Surgipedia web site:
Lessons learnt
- The main roadblock to the development of CRAS technologies that can be transferred into products is the lack of a prolonged and focused financial support. European technologies are at the forefront of research, but funds available, either through EU grants or private ventures, are much lower (orders of magnitude) of what is necessary to make the technology reach the level of medical product.
- The EU projects are not designed to promote innovation and the research results are often not exploited by the industrial community because there is no mechanism to bridge the gap between the proof of concept demonstrated by a research project and the product prototype needed to attract the interest of an industrial partner.
- Robotic surgery is still a fragmented field and the insertion of high technology devices, e.g. a robot, in the surgical process is unbalancing a well established process, requiring new efforts in education, safety definition and monitoring, and process modelling, to ensure that quality and patient safety are not harmed by the new technologies.