Digital Health Driven Therapy Systems
ACMIT is putting main emphasis on the development of new technology for minimally and micro-invasive procedures with increased consideration of surgical data aspects with the slogan “Digital Health Driven Therapy Systems“.
From technical and “procedural” viewpoint, research and development in ACMIT is covering the entire chain of activities – starting from advanced planning of the therapy, over the delivery of therapy by smart tools (e.g. with in-situ monitoring of therapy, advanced control of the therapy process) and guidance of such tools (e.g. by means of medical robotic systems or navigation technology), up to aspects related to the operator site (e.g. work-flow support) and even beyond (e.g. establishing of a surgical knowledge base for a more global advancement of surgical procedures). To complete the chain of translational research and development, work in ACMIT also includes evaluation of such new technology in realistic clinical setups which also addresses the increased requirements from the EU Medical Device Regulation (MDR). ACMIT research and development activities are structured into three research areas. The research scope has been mapped onto a “Sense – Plan – Act” structure.
Autonomy in Surgery
This research area is dealing with tools and methods for delivery of treatment, i.e. for the transfer of planned action into action – also including methods for adaptation of planned actions based on situation awareness. In the deliberative control scheme of a therapy process, this area is covering the “acting” phase.
Research tasks of topic “Smart Tools and Instruments” address some of the key points for improvement of state of the art MIS procedures. Based on the existing concept for steerable stylets and trocars, tools will be developed for concrete applications and tested clinically. Tool design activities also will be related to integration of the sensors developed in research area Sensor Systems for Diagnosis and Therapy into surgical tools for real-time in vivo therapy monitoring. Finally, investigation of new surgical access systems will complete the range of activities regarding “smart tools”. Furthermore, new application setups for our existing robot technology will be investigated as well as concepts for Cognitive Surgical Systems. For the latter topic, especially aspects of autonomous task execution as well as collaborative human/robot setups will be analysed in terms of concrete clinical use cases.
Tasks of topic “Information-based Therapy” aim to investigate concepts for data-based treatment. New methods for surgical navigation will be developed, including efficient and accurate registration, soft tissue navigation, and navigation based on real-time imaging. Furthermore, we address treatment optimization based on sensor data in a local context, as well as globally by investigation of methods related to “Surgical IoT” and “Surgical Data Science”.
Surgical Data for Optimized Therapy
"Surgical Data Science" (SDS) is an emerging field and a major contribution to the current trend towards “Digitalized Medicine” and “Surgery 4.0”. SDS comprises the structured acquisition of relevant data across the entire chain of diagnostic and therapeutic actions and the use of the resulting data pools in order to optimize therapeutic procedures.
The COMET Module “Surgical Data for Optimized Therapy” (SD-OpT) by ACMIT is representing an important extension of ACMIT’s research areas, such as sensor-integrated tools, medical IoT or patient-specific planning tools, which provide an ideal base for “Surgical Data Science” (SDS).
SD-OpT investigates methods of manual and automatic knowledge extraction from data streams and analysis of application-specific data in order to identify relevant correlations to optimize diagnosis and treatment. SD-OpT demonstrates the immense potential of SDS by realization of representative and meaningful evaluation cases. The results from SD-OpT will be integrated by ACMIT into advanced “Digital Health driven Therapy Systems”.
The R&D activities are structured into three projects:
- PR1: Information Modeling, Storage and Distribution
- PR2: Data Analysis and Knowledge Extraction
- PR3: Evaluation of SDS in key clinical applications
SD-OpT establishes a grand coalition of leading institutes in key areas of SDS - a close cooperation of international high-profile partners from science and industry.
- Delft University of Technology, Department of BioMechanical Engineering (Delft, NL)
- German Cancer Research Center DKFZ (Heidelberg, DE)
- Innovation Center for Computer-Assisted Surgery ICCAS (Leipzig, DE)
- INSERM/MediCIS, University of Rennes (Rennes, FR)
- Tokyo Women’s Medical University, ABMES (Tokyo, JP)
- University of Innsbruck, Department of Computer Science (Innsbruck, AT)
- Dr. Pierre Jannin, MediCIS/INSERM - University of Rennes
- Dr. Thomas Neumuth, ICCAS- University of Leipzig
- Dr. Keno März, DKFZ Heidelberg
- EBG MedAustron GmbH (Wiener Neustadt, AT)
- Erbe Elektromedizin GmbH (Tübingen, DE)
- Evaluation Software Development GmbH (Innsbruck, AT)
- Richard Wolf GmbH (Knittlingen, DE)
- World-Direct eBusiness solutions GmbH (Sistrans, AT)
Sensor Systems for Diagnosis and Therapy
This research area is mainly dealing with the development of novel sensor technology for therapy monitoring and thus covers the “sensing” phase in the deliberative control scheme of a therapy process.
This research area is addressing the topics “Advanced Sensor Systems” and “Improving Quality of Vision”.
“Advanced Sensor Systems” essentially aim to provide intra-operative surgeon feedback by system/instrument integrated sensor components. Giving surgeons a real-time feedback about the actually treated tissue can significantly improve the intervention or directly provide diagnostic results. Planned activities include in particular the development of miniaturized sensor components for integration in instruments for minimal invasive surgery, for example for needle based sensorized tools. Together with sensor data acquisition and signal analysis these topics constitute the main research activities. Another part of activities is related to sensorized systems and tools which are not directly involved in surgical interventions. These tasks activities for point of care applications which are settled in the fields of prevention and home care monitoring. Their goal is to provide patient individual data for diagnosis and therapy related decision-making.
Based on our optic design know-how in combination with simulations tools, the topic “Improving Quality of Vision“ deals with development of optical elements under the umbrella of the term “Quality of Vision”. Main focus of activities is in ophthalmology, especially including optic design concepts for intraocular lenses (IOLs) in combination with methods and tools for assessment of the subjective vision quality and patient satisfaction. Multifocal as well as extended depth of focus IOLs not only allow to satisfy individual preferences in cataract surgery, but also entail the need for increased patient guidance, which has to be supported by appropriate tools during the clinical workflow practice. Therefore, lens design for capsular bag IOLs as well as supplementary lens platforms belong to the main research tasks. Besides these activities in ophthalmology, we work on optical setups and components which are not directly dedicated to a sensory functionality, such as improvement of the surgeon’s limited view in endoscopic applications.
Therapy Planning and Workflow Support
This research area is dealing with new methods for planning of treatment in the pre-operative phase as well as with different aspects of workflow support in order to help the surgeon to sufficiently adhere to such a plan. In the deliberative control scheme of a therapy process, this area thus is covering the “planning” phase.
The topic “Therapy Workflow Support” is dealing with different aspects of workflow support, starting with an update of our current workflow assessment system, development of a generic workflow modelling toolbox, and implementation of a workflow engine. One core activity is generation of process specific process models and their use for workflow monitoring and workflow support systems. The aforementioned modules will be integrated to demonstrators in different configurations and for different clinical use cases.
The topic “Advanced Planning Concepts” basically deals with two different approaches for pre-operative planning. Investigation of software tools for planning in particular spotlights the integration of simulation methods into the planning procedure for immediate estimation of the effect of treatment and iterative improvement of the plan. In addition, the potential use of pre-existing data/knowledge for optimal planning will be investigated. Furthermore, different aspects and options of the use of Additive Manufacturing for pre-operative planning will be analyzed in detail – including the application of this planning method in selected use cases.
Artificial Intelligence Guidance for Robot-Assisted Eye Surgery (GEYEDANCE)
- University of Verona, Altair Robotics Laboratory, Italy
- PRECEYES BV, Netherlands
- University of Ferrara, Italy
- University of Bern, ARTORG Center for Biomedical Engineering Research, Switzerland
- Coordination of the project
- Performation of translational R&D for new therapy options, including regulatory affairs management
- PRECEYES’s robotic system will be used and adapted to include a unique intraocular distance-sensing modality developed by ACMIT
- Development and evaluation of the Artificial Intelligence (AI) - guidance system during assessment of the clinical and usability requirements
- Formulation of the use scenarios
- GEYEDANCE AI - based system supports retinal surgeons to optimize their task, in order to reduce the mental and physical load of the surgeon
- Contribution of a better surgical outcome for the patients
- Generation of tangible and “close-to-certification” technology being evaluated in the framework of a first clinical trial.
- CE certified robot platform PRECEYES Surgical System
- A prototype for a Common-Path optical coherence tomography (OCT) system with extended measurement depth from ACMIT
- Development of AI-components
- A board of world-wide leading eye surgeons, led by University of Ferrara, provide user insight and evaluate the results
Mimicking Adaptation and Plasticity in WORMS (MAPWORMS)
- Sant’Anna School of Advanced Studies, The BioRobotics Institute, Italy
- National Inter-University Consortium for Marine Sciences, Italy
- Hellenic Centre for Marine Research, Institute of Marine Biology, Biotechnology and Aquaculture, Greece
- Hebrew University of Jerusalem, Chemistry Department, Israel
- Vexlum Ltd., Finland
- Translational R&D for new therapy options
- Development of sensor systems for surgical procedures
- Development of a multi-material 3D printer
- Developing the first bioinspired shape-morphing robot based on stimuli-responsive materials
- Inspired by the marine Annelida
- Completely autonomous robot, able to fulfill different tasks by adapting to the environment
- Smart shape-memory hydrogels representing morphing robots combining with non-reactive elements
- US scanners with high-resolution transducers for realtime imaging of the actuator/robot elements
- Set of medical 3D tracking systems for realtime tracking of actuator/robot elements
- Different 3D printers for rapid prototyping
- Experimental OR for validation/demonstration of selected biomedical use-cases
- Tools and evaluation setup for optical and fiber-optical elements
Smart Autonomous Robotic Assistant Surgeon (SARAS)
- University of Verona (UNIVR), Italy
- University of Moderna and Reggio Emilia (UNIMORE), Italy
- University of Ferrara (UNIFE), Italy
- Ospedale San Raffaele (OSR), Italy
- Universitat Politecnica de Catalunya (UPC), Spain
- University of Dundee (UNIVDUN), UK
- Oxford Brookes University (OBU), UK
- Medineering GmbH (MEDIN), Germany
- System integration and phantom augmentation
- Development of multi-functional tools, medical robotics, training systems for medical/surgical education and training, as well as workflow analysis
- Technical specification and optimization
- Usability engineering and support of company partners with product certification
- Support of dissemination activities with its network of clinical partners and hospital operators
- Open new markets in surgical robotics, phantoms design and training to commercially disseminate the project results
- Certified development processes (ISO 13485)
- Development of the next-generation of surgical robotic systems with a single surgeon to execute Robotic Minimally Invasive Surgery (R-MIS) without the need of an expert assistant surgeon
- Solo-surgery system consisting of a pair of cooperating and autonomous robotic arms holding the surgical instruments
- Leverage on a ground-breaking artificial intelligence (AI) module to develop a cognitive robotic system capable of autonomously understanding the present and future surgical situation, and performing its predefined actions at the right place and time
- SARAS assistive robotic arms are able to perform the same tasks that are now carried out by the assistant surgeon during a robotic or a laparoscopic procedure
Medical Device Obligations Taskforce (MDOT)
- Fraunhofer Gesellschaft zur Förderung der Angewandten Forschung E.V., Germany
- DEMCON advanced mechatronics Zuid B.V., Netherlands
- Universität Bayreuth, Germany
- Borm Nanoconsult Holding BV, Netherlands
- FUNDACION CIDETEC, Spain
- MDR Competence, Germany
- Medizinische Hochschule Hannover, Germany
- Wyss Center for Bio and NeuroEngineering, Switzerland
- University of Southampton, UK
- University of Linz, Austria
- Uniwersytet Medyczny im Karola Marcinkowskiego W Poznaniu, Poland
- University of Leeds, UK
- Minimally invasive surgery
- Database development
- Consultation node
- Quality and risk management
- Prototyping for clinical testing
- Establishment of a data platform for simplified and affordable conformity and safety assessment tailored to the regulatory needs of MedTech Small and Mid-sized Enterprise (SMEs) in light of Medical Device Regulation (MDR)
- Improve and advance testing beds for medical devices in light of the MDR
- Reduce the burden of MDR for SMEs who cannot easily afford the required testing
- Make use of automation and prediction where possible and sensible
- The goal of MDOT is to establish a sustainable platform that enables MedTech SMEs:
- to establish a database of detailed testing data of commonly used components
- to safely and transparently exchange testing data using state-of-the-art technology to decrease cost while increasing quality and safety of medical device innovations
- to perform pre-clinical evaluations of commonly used parts together
- to get access to advanced testing and fabrication methods