Periodic Reporting for period 2 - ARTERY (Autonomous Robotics for Transcatheter dEliveRy sYstems)
Periodo di rendicontazione: 2022-07-01 al 2024-09-30
Cardiovascular diseases (CVDs) cause about 50% of all deaths in the EU, and are a major cause of life quality impairment, loss of productivity and healthcare costs, with an estimated burden of €210 billion/year on EU economy. Structural heart diseases (SHDs), affecting any cardiac structure but coronary vessels, form almost 30% of CVD cases. SHDs must be treated through open-chest surgery or transcatheter approaches. Open chest surgery bears serious risks and is not suitable for patients characterized by old age, comorbidities, or previous heart surgery. Transcatheter approaches allow to treat these patients as well: catheters are inserted in a vessel through a small peripheral access and driven to the heart to implant life-saving devices. With EU ageing population, the need for transcatheter interventions will increase.
While increasingly popular, transcatheter approaches are highly technical, not ergonomic and with a steep learning curve. Only few excellence centres offer these approaches, still with no guarantee of procedural success and freedom from complications. Also, X-ray imaging is massively used during the procedure, with potential harm to patients and operators.
To address these challenges, the ARTERY project developed an advanced robotic-assisted platform that integrates five cutting-edge technologies that will maximize operators’ awareness and precision during interventions, while minimizing X-ray related risks, as well as operators’ physical and mental workload:
- Hybrid sensors and real-time computer modelling to reconstruct catheters’ shape, position, and interaction with vessels without X-ray imaging
- Artificial intelligence (AI)-based annotation of 3D transesophageal echocardiography (RT3DTEE) imaging to automatically identify key anatomical structures and the catheter in the intracardiac space
- Robotic actuators to precisely actuate sensorized catheters and RT3DTEE probe
- Advanced control systems, featuring AI-based path planning and closed-loop controllers, for autonomous robot operations
- Mixed Reality (XR) interfaces for intuitive visualization of imaging/data and interaction with the robotic platform
While increasingly popular, transcatheter approaches are highly technical, not ergonomic and with a steep learning curve. Only few excellence centres offer these approaches, still with no guarantee of procedural success and freedom from complications. Also, X-ray imaging is massively used during the procedure, with potential harm to patients and operators.
To address these challenges, the ARTERY project developed an advanced robotic-assisted platform that integrates five cutting-edge technologies that will maximize operators’ awareness and precision during interventions, while minimizing X-ray related risks, as well as operators’ physical and mental workload:
- Hybrid sensors and real-time computer modelling to reconstruct catheters’ shape, position, and interaction with vessels without X-ray imaging
- Artificial intelligence (AI)-based annotation of 3D transesophageal echocardiography (RT3DTEE) imaging to automatically identify key anatomical structures and the catheter in the intracardiac space
- Robotic actuators to precisely actuate sensorized catheters and RT3DTEE probe
- Advanced control systems, featuring AI-based path planning and closed-loop controllers, for autonomous robot operations
- Mixed Reality (XR) interfaces for intuitive visualization of imaging/data and interaction with the robotic platform
The ARTERY platform was developed and tested on two use cases: mitral valve (MV) transcatheter edge-to-edge repair (TEER) and percutaneous left atrial appendage closure (PLAAC).
TEER is one of the most complex transcatheter approaches to SHDs. Most TEER procedures are performed with the MitraClip System, which requires to manoeuvre a Steerable Guide Catheter (SGC) and a Steerable Delivery Catheter (SDC) to precisely deliver a clip on the MV under the guidance of X-ray fluoroscopy and RT3DTEE imaging. The ARTERY platform allowed to robotize the use of the MitraClip System and eliminate the need for X-ray fluoroscopy, thanks to five technological developments:
- Advanced Sensor Integration and Data Fusion - electromagnetic (EM) and Fiber Bragg Grating (FBG) sensors were integrated to track the position and shape of the SGC, the SDC, and the RT3DTEE probe. Advanced real-time data fusion and filtering techniques improved the tracking accuracy and reliability.
- AI-driven Image Analysis and Annotation – an AI-based pipeline was implemented to automatically and accurately segment and reconstruct MV substructures in RT3DTEE images.
- Robotic Systems for Catheter and Probe Manipulation – lightweight robotic drivers were developed to precisely actuate all the degrees of freedom (DOFs) of the sensorized SGC, SDC, and RT3DTEE probe.
- Control and Navigation – the project developed an AI-driven path planner and a robust control algorithm. Moreover, closed-loop adaptive control systems were developed to enable the coordinated manipulation of the SGC/SDC and of the RT3DTEE probe.
- XR Interface - the XR interface was enhanced to enable i) the real-time visualization of catheter-vessel interactions, ii) the interactive navigation of annotated RT3DTEE imaging, iii) the intuitive definition and the fine-tuning of the SDC’s target pose.
PLAAC implants an occluder in the left atrial appendage. Technologies from the TEER use case were adapted to satisfy PLAAC-related requirements. On top of those, two key technologies were developed and prototyped:
- Two multi-DOF steerable sheath designs based on Nitinol and PEBAX structures, respectively. Both designs incorporate two bending segments controlled by tendon-driven actuators and housings for sensors.
- A sensorized delivery catheter capable to measure deployment forces during occluder implantation, providing real-time feedback on catheter positioning and implant stability.
For both use-cases the ARTERY platform was validated in vitro in a real OR, using anatomically realistic wet simulators. The final tests demonstrated the potential of the ARTERY robotic-assisted platform to transform SHD treatments.
TEER is one of the most complex transcatheter approaches to SHDs. Most TEER procedures are performed with the MitraClip System, which requires to manoeuvre a Steerable Guide Catheter (SGC) and a Steerable Delivery Catheter (SDC) to precisely deliver a clip on the MV under the guidance of X-ray fluoroscopy and RT3DTEE imaging. The ARTERY platform allowed to robotize the use of the MitraClip System and eliminate the need for X-ray fluoroscopy, thanks to five technological developments:
- Advanced Sensor Integration and Data Fusion - electromagnetic (EM) and Fiber Bragg Grating (FBG) sensors were integrated to track the position and shape of the SGC, the SDC, and the RT3DTEE probe. Advanced real-time data fusion and filtering techniques improved the tracking accuracy and reliability.
- AI-driven Image Analysis and Annotation – an AI-based pipeline was implemented to automatically and accurately segment and reconstruct MV substructures in RT3DTEE images.
- Robotic Systems for Catheter and Probe Manipulation – lightweight robotic drivers were developed to precisely actuate all the degrees of freedom (DOFs) of the sensorized SGC, SDC, and RT3DTEE probe.
- Control and Navigation – the project developed an AI-driven path planner and a robust control algorithm. Moreover, closed-loop adaptive control systems were developed to enable the coordinated manipulation of the SGC/SDC and of the RT3DTEE probe.
- XR Interface - the XR interface was enhanced to enable i) the real-time visualization of catheter-vessel interactions, ii) the interactive navigation of annotated RT3DTEE imaging, iii) the intuitive definition and the fine-tuning of the SDC’s target pose.
PLAAC implants an occluder in the left atrial appendage. Technologies from the TEER use case were adapted to satisfy PLAAC-related requirements. On top of those, two key technologies were developed and prototyped:
- Two multi-DOF steerable sheath designs based on Nitinol and PEBAX structures, respectively. Both designs incorporate two bending segments controlled by tendon-driven actuators and housings for sensors.
- A sensorized delivery catheter capable to measure deployment forces during occluder implantation, providing real-time feedback on catheter positioning and implant stability.
For both use-cases the ARTERY platform was validated in vitro in a real OR, using anatomically realistic wet simulators. The final tests demonstrated the potential of the ARTERY robotic-assisted platform to transform SHD treatments.
The ARTERY project achieved significant progress aligned with its six main expected results:
- Defining Sensing and Actuation Technology for a New Generation of Steerable Catheters
We developed advanced and sensorized steerable catheters and robotic actuation systems, which allow for unprecedented control in complex, fragile, and dynamic cardiac environments.
- A Leap in RT3DTEE Data Interpretability
AI-driven pipelines were implemented to annotate RT3DTEE images, achieving high accuracy (Dice similarity score >0.76) in identifying intracardiac structures.
- XR-mediated Intuitive Interaction
XR interfaces allowed for the ergonomic, smooth and real-time (>30 fps) visualization of catheter-vessel interaction and of the 3D intracardiac space, empowering operators' awareness and decision-making, and allowing for the intuitive definition of the target pose of the catheter.
- Precise Autonomous Navigation in Dynamic Environments
The AI-based path planner computes optimal trajectories, whose correct implementation is guaranteed by closed-loop control, achieving position and orientation accuracies of 0.63 mm and 5.99°. The result is reduced cognitive load and enhanced procedural precision.
- Elimination of Intraprocedural X-Ray Imaging
Combining catheter sensorization, real-time and high-fidelity simulations of catheter-vessel interaction, and automatically annotated RT3DTEE rendering, ARTERY allowed full awareness of catheter and target positions without X-ray imaging, eliminating the harmful effects of ionizing radiations.
- Demonstrating Feasibility of Robotic SHD Transcatheter Treatments
In vitro tests in a real OR on TEER and PLAAC procedures confirmed the feasibility of using robotic systems to enhance the precision, safety, and efficiency of SHD treatments.
Impact on SHD Percutaneous Treatments
ARTERY advancements collectively enhance precision, reduce risks, and streamline the learning curve for complex procedures. These results suggest that ARTERY technology has the potential to make SHD treatments easier to learn and safer to perform, making them accessible to a broader range of healthcare facilities, benefiting more patients globally.
Impact on the Robotic Surgery Market
The global surgical robotics market is projected to grow by 9.7%/year over the next five years, driven by the increasing demand for minimally invasive procedures. Yet, in 2p16 robotic systems for interventional cardiology represented only 5% of the market, with an expected rise to just 6% by 2025. ARTERY technologies address unmet needs in interventional cardiology, creating new market growth opportunities.
- Defining Sensing and Actuation Technology for a New Generation of Steerable Catheters
We developed advanced and sensorized steerable catheters and robotic actuation systems, which allow for unprecedented control in complex, fragile, and dynamic cardiac environments.
- A Leap in RT3DTEE Data Interpretability
AI-driven pipelines were implemented to annotate RT3DTEE images, achieving high accuracy (Dice similarity score >0.76) in identifying intracardiac structures.
- XR-mediated Intuitive Interaction
XR interfaces allowed for the ergonomic, smooth and real-time (>30 fps) visualization of catheter-vessel interaction and of the 3D intracardiac space, empowering operators' awareness and decision-making, and allowing for the intuitive definition of the target pose of the catheter.
- Precise Autonomous Navigation in Dynamic Environments
The AI-based path planner computes optimal trajectories, whose correct implementation is guaranteed by closed-loop control, achieving position and orientation accuracies of 0.63 mm and 5.99°. The result is reduced cognitive load and enhanced procedural precision.
- Elimination of Intraprocedural X-Ray Imaging
Combining catheter sensorization, real-time and high-fidelity simulations of catheter-vessel interaction, and automatically annotated RT3DTEE rendering, ARTERY allowed full awareness of catheter and target positions without X-ray imaging, eliminating the harmful effects of ionizing radiations.
- Demonstrating Feasibility of Robotic SHD Transcatheter Treatments
In vitro tests in a real OR on TEER and PLAAC procedures confirmed the feasibility of using robotic systems to enhance the precision, safety, and efficiency of SHD treatments.
Impact on SHD Percutaneous Treatments
ARTERY advancements collectively enhance precision, reduce risks, and streamline the learning curve for complex procedures. These results suggest that ARTERY technology has the potential to make SHD treatments easier to learn and safer to perform, making them accessible to a broader range of healthcare facilities, benefiting more patients globally.
Impact on the Robotic Surgery Market
The global surgical robotics market is projected to grow by 9.7%/year over the next five years, driven by the increasing demand for minimally invasive procedures. Yet, in 2p16 robotic systems for interventional cardiology represented only 5% of the market, with an expected rise to just 6% by 2025. ARTERY technologies address unmet needs in interventional cardiology, creating new market growth opportunities.