Work Package interaction
Six work packages have been set up within the INCITE project. WP1 defines clinical user cases and translates them into system requirements. Following these system requirements, WP2, 3 and 4 design systems and components, develop technologies and build functional demonstrators for the four major functionalities: imaging, sensing and steering, respectively. Product manufacturer partners are involved in each of these work packages to ensure a seamless transition from the concept towards a demonstrator which, after the pre competitive phase, can be transferred into a manufacturable process, resulting a high performance product. The evaluation of these demonstrators is carried out in WP1 by the clinical end-users, completing the loop. WP5 coordinates dissemination, exploitation and standardization activities. A separate work package, WP6, is dedicated to project management. An overview of the work packages and their interdependencies are shown in the figure below.
Demonstrators and research
In order to best balance the need for high innovation level and the need for prototypes suitable for commercial exploitation, each technical work package (WP2-4) makes a distinction between demonstrator-oriented activities and research-oriented activities based on the maturity of involved technologies. Technologies chosen for the demonstrator paths have a higher maturity level. Technologies chosen for the research path are at an earlier stage for catheter applications. By being in the same consortium (and work packages) with clinical end users and product manufacturers, the development of these more novel technologies can be significantly accelerated since insights on user need, system requirement and manufacturability can be taken into consideration from beginning.
WP1 - End user requirements and evaluationWP1 serves as both end-user and system architect in the project. It consists of clinical partners, system manufacturers and representatives from WP2-4. Activities include:
- Define specific clinical cases in electrophysiology, interventional cardiology and structural heart disease and user requirements for each of the advanced functionalities.
- Translate the user requirements into system requirements and specifications.
- Define demonstrators in collaboration with the other work packages.
- Define feasibility experiments (tissue/phantom model or preclinical) to test hypothesis on the added clinical benefit of selected functionalities based on existing commercial devices.
- Define user evaluation plans and develop protocols.
- Execute user evaluation (in vitro and preclinical).
WP2 - ImagingUsing system requirement input from WP1, WP2 designs and realizes in-body ultrasound imaging functionalities for catheters. WP2 consists of partners with component, assembly, software and system integration expertise that is needed for the ultrasound imaging catheter demonstrator. Activities include:
- Design, fabricate and test MEMS ultrasound transducer arrays (CMUT).
- Perform acoustic modelling to optimize transmit and driving schemes.
- Design and realize catheter tip ASIC for driving and reading out imager.
- Investigate advanced interconnect and data link technologies.
- Test imagers, interconnect, data link and ASIC components.
- Integrate the components into a ultrasound imaging catheter demonstrator, including data/signal processing interfaces.
- Perform bench testing of integrated system.
- Design, fabricate and test MEMS ultrasound transducer arrays (PMUT).
- Investigate advanced interconnect, integration and processing technologies for further miniaturization.
- Investigate new driving schemes for optimal CMUT imaging.
- Develop and validate ultrasound simulation model to guide next-generation device designs.
WP3 - SensingUsing module requirement input from WP1, WP3 designs and realizes sensing functionalities for catheters. WP3 consists of partners with component, assembly, software and system integration expertise that is needed for the various sensing catheter demonstrators. Activities include:
- Design and fabricate sensing modules: MEMS 3D force sensor, MEMS pressure sensor.
- Design and fabricate catheter tip ASICs / modular multi-chip components for driving and reading out sensors.
- Test sensors, interconnect, and electronic components.
- Integrate contact force sensors within a surgical robotic arm.
- Demonstrate the integrabilty of the developed force sensor and data/signal processing interfaces.
- Perform bench testing of integrated system.
- Investigate novel biosensor for determination of biomarkers in blood.
- Investigate combined position and pressure sensing using CMUT.
WP4 - SteeringUsing module requirement input from WP1, WP4 investigates novel steering mechanisms for catheters. WP4 consists of partners with material, actuator, control and system integration expertise that is needed for the steerable catheter demonstrator(s). Activities include:
Demonstrator activities (shape memory alloy based actuation):
- Design actuator shape and electrical interfaces. Multiphysics modelling will be performed to aid in the design and for choosing mechanical properties of catheter materials;
- Design and build a bench top test setup for evaluation of smart material based actuators performance in a catheter-based form factor;
- Design control strategy. Build control unit(s) including software for selected actuators;
- Integrate these novel smart material actuators and control units into a steerable catheter tip demonstrator. Test at both module and system level.
Research activities (electroactive polymer based actuation):
- Synthesize electrostricitive polymers for steering application.
- Develop process for creating thin films and stacking.
- Develop process for deposition of arrays of electrodes on the catheter surface.
WP5 - Dissemination, exploitation and standardizationWP5 will coordinate the use of various channels to disseminate project results and to promote awareness of its progress towards potential users and customers as well as to the research community. WP5 will also manage and plan the exploitation of project output, the contribution to standardization, and the protection of Intellectual Property. This will be done in the tasks:
- Intellectual Property
WP6 - Project ManagementWP6 deals with the coordination and daily management of the project and the consortium. Moreover, the responsibility of the Project Board is to execute the overall supervision of the Work Packages. WP6 will also manage the communication between all stakeholders. This includes the interaction with the Project Officer and the European Commission. WP6 will ensure a harmonized and consistent approach within the project and alignment with the relevant parties concerned outside the consortium. WP6 consists of the tasks:
- Consortium management
- Project and work package management
- Relationship management with ENIAC office