Periodic Reporting for period 1 - ARTERY (Autonomous Robotics for Transcatheter dEliveRy sYstems)
Periodo di rendicontazione: 2021-01-01 al 2022-06-30
The European Cardiovascular Disease Statistics 2017 attribute about half of all deaths across EU to cardiovascular diseases (CVDs). CVDs are a major cause of life quality impairment, loss of productivity and healthcare costs. A burden of €210 billion/year on EU’s economy is estimated. Structural heart diseases (SHDs), affecting any cardiac structure but coronary vessels, form almost 30% of CVD cases. SHDs require surgical treatment. The standard surgical treatment, i.e. open-chest surgery, bears serious risks and is not suitable for patients characterized by old age, comorbidities, or previous heart surgery, nor for newborns affected by congenital defects. For these patients, the alternative consists in percutaneous approaches; these use catheters, inserted through a small peripheral access and driven to the heart over blood vessels, to implant life-saving devices. With Europe’s ageing population the number of these patients and the need for these interventions will increase.
While increasingly popular, percutaneous approaches are highly technical, not ergonomic and with a steep learning curve. Only a restricted number of excellence centres offer these life-saving approaches, and, even then, procedural success and freedom from complications are not guaranteed. Also, X-ray imaging with nephrotoxic contrast agents is massively used during the procedure, with potential harm to patients and operators.
ARTERY will revolutionize the field of SHD percutaneous treatments by introducing a variable shared autonomy robotic platform: robotic actuators will finely manipulate sensorized catheters and a sensorized probe for real-time 3D trans-esophageal echocardiography (RT3DTEE); information from sensors, from RT3DTEE data automatically annotated by an artificial intelligence (AI), and from computer modeling will be used to control the robotic actuators, and it will be made available to the operator through an augmented reality (AR) interface allowing for monitoring and intuitive interaction with the platform. This new technology will make SHD percutaneous treatments faster, more controllable, less mentally demanding, and easier to learn and execute, and hence accessible to more centres. Additionally, it will reduce X-ray exposure of operators and patients.
While increasingly popular, percutaneous approaches are highly technical, not ergonomic and with a steep learning curve. Only a restricted number of excellence centres offer these life-saving approaches, and, even then, procedural success and freedom from complications are not guaranteed. Also, X-ray imaging with nephrotoxic contrast agents is massively used during the procedure, with potential harm to patients and operators.
ARTERY will revolutionize the field of SHD percutaneous treatments by introducing a variable shared autonomy robotic platform: robotic actuators will finely manipulate sensorized catheters and a sensorized probe for real-time 3D trans-esophageal echocardiography (RT3DTEE); information from sensors, from RT3DTEE data automatically annotated by an artificial intelligence (AI), and from computer modeling will be used to control the robotic actuators, and it will be made available to the operator through an augmented reality (AR) interface allowing for monitoring and intuitive interaction with the platform. This new technology will make SHD percutaneous treatments faster, more controllable, less mentally demanding, and easier to learn and execute, and hence accessible to more centres. Additionally, it will reduce X-ray exposure of operators and patients.
ARTERY considers two scenarios to develop its solutions.
1) the implantation of the MitraClip device, as it is one of the most complex transcatheter approaches to SHDs, and it hence represents a challenging benchmark. The MitraClip system has been actuated, sensorized and controlled. The actuation system has been separately developed for the Steerable Guide Catheter (SGC) and the Clip Delivery System (CDS) by replicating the same degrees of freedom required for the MVR procedure. The sensorization aims to track the actual position and the live shape of the catheter combining Electromagnetic (EM) and Fiber Bragg Grating (FBG) sensors. A first position control algorithm based on a PID controller was developed, along with i) the real-time numerical modeling of catheter vessel-interaction and ii) a 3D U-Net convolutional neural network that automatically annotates RT3DTEE data. The AR interface has been developed and tested to i) visualize the catheter-vessel interaction as computed by the numerical model, ii) navigate the annotated RT3DTEE data during the intracardiac phase of the procedure, iii) virtually define the ideal pose of the catheter tip based on such information. Fast data transfer between the software modules of the platform has been verified. Furthermore, a path planner has been developed to compute the optimal catheter path through the left to the target pose defined by the end-user. The path planner is based on Inverse Reinforcement Learning. Thus, an Inverse Kinematic model of CDS, based on Cosserat Rod Theory, links the target position to the actuation system variable of control. Finally, a RT3DTEE probe has been sensorized by a 6-Degrees of Freedom (DoF) Inertial Measurement Unit and a 6-DoF EM sensor. Realtime data fusion and filtering techniques will satisfy accurate orienting in the TEE probe. The actuation systems for both drivers (MitraClip delivery and RT3DTEE) are attached to the end-effector of two lightweight robots.
2) left atrial appendage closure: a first investigation of the needed requirements has been performed, defining the actuation, sensorization and control conditions to be implemented. These requirements are leveraging the outcomes from the first scenario.
1) the implantation of the MitraClip device, as it is one of the most complex transcatheter approaches to SHDs, and it hence represents a challenging benchmark. The MitraClip system has been actuated, sensorized and controlled. The actuation system has been separately developed for the Steerable Guide Catheter (SGC) and the Clip Delivery System (CDS) by replicating the same degrees of freedom required for the MVR procedure. The sensorization aims to track the actual position and the live shape of the catheter combining Electromagnetic (EM) and Fiber Bragg Grating (FBG) sensors. A first position control algorithm based on a PID controller was developed, along with i) the real-time numerical modeling of catheter vessel-interaction and ii) a 3D U-Net convolutional neural network that automatically annotates RT3DTEE data. The AR interface has been developed and tested to i) visualize the catheter-vessel interaction as computed by the numerical model, ii) navigate the annotated RT3DTEE data during the intracardiac phase of the procedure, iii) virtually define the ideal pose of the catheter tip based on such information. Fast data transfer between the software modules of the platform has been verified. Furthermore, a path planner has been developed to compute the optimal catheter path through the left to the target pose defined by the end-user. The path planner is based on Inverse Reinforcement Learning. Thus, an Inverse Kinematic model of CDS, based on Cosserat Rod Theory, links the target position to the actuation system variable of control. Finally, a RT3DTEE probe has been sensorized by a 6-Degrees of Freedom (DoF) Inertial Measurement Unit and a 6-DoF EM sensor. Realtime data fusion and filtering techniques will satisfy accurate orienting in the TEE probe. The actuation systems for both drivers (MitraClip delivery and RT3DTEE) are attached to the end-effector of two lightweight robots.
2) left atrial appendage closure: a first investigation of the needed requirements has been performed, defining the actuation, sensorization and control conditions to be implemented. These requirements are leveraging the outcomes from the first scenario.
ARTERY has 6 main expected results:
1) to devise the defining sensing and actuation technology of a new generation of steerable catheters, with unprecedented controllability and inherent safe interaction in a fragile dynamic environment.
2) to establish a leap in interpretability of RT3DTEE data, radically improving the operator’s awareness of the cardiac space.
3) intuitive interaction with the intracardiac space and definition of the intracardiac trajectories: operators will only need to define the final pose of the catheter tip, while now they need to figure out the complex set of manipulations of the proximal end of the catheter that will produce the desired effect at the catheter tip.
4) precise autonomous navigation through an unstructured and dynamic environment.
5) to eliminate intraprocedural X-ray imaging
6) to demonstrate the feasibility of the robotic implementation of SHD percutaneous treatments with current transcatheter technologies.
ARTERY can impact the widespread of SHD percutaneous treatments. Of note, despite being conceived to provide an alternative to high-risk patients, percutaneous treatments of SHDs are becoming a valid alternative to classic open-chest surgery also for moderate- and even low-risk patients, in that, these procedures i) have proven non-inferior or even superior to open-chest surgery in terms of effectiveness and freedom from adverse events, ii) avoid the risks associated to cardio-pulmonary bypass, iii) allow for shorter hospitalization time and much faster patient recovery. These factors, together with the lower rate of rehospitalization, make SHD percutaneous treatments cost-effective in different continents and healthcare systems, and in some cases even cost-saving and profitable to hospitals.
ARTERY can also impact the robotic surgery market. A 9.7% growth of the global surgical robotics market is expected in the next 5 years, due to the increase in patient demand for minimally invasive treatments and standardized surgeries, and in need for flexibility and precision in the operating room. According to the Economics Times, interventional cardiology is rated as only 5% of the global surgical robotics in 2016 and it will grow to only 6% in 2025, a relatively small market as compared to the incidence of cardiovascular diseases. In the light of the market projection relative to SHD devices, it is credible that, while examples of robotic systems are present (e.g. Sensei X, CorPath GRX), there is still room to open-up a barely scraped market for robotic devices, provided that disruptive technologies are developed. Moreover, IP ownership and market are dominated by the USA, thanks to the early investments that provided an extensive patent portfolio, early adoption, and doctors/patient acceptance of such technologies. ARTERY-related new technology and IP are expected to help balancing the market of surgical robotics toward Europe.
1) to devise the defining sensing and actuation technology of a new generation of steerable catheters, with unprecedented controllability and inherent safe interaction in a fragile dynamic environment.
2) to establish a leap in interpretability of RT3DTEE data, radically improving the operator’s awareness of the cardiac space.
3) intuitive interaction with the intracardiac space and definition of the intracardiac trajectories: operators will only need to define the final pose of the catheter tip, while now they need to figure out the complex set of manipulations of the proximal end of the catheter that will produce the desired effect at the catheter tip.
4) precise autonomous navigation through an unstructured and dynamic environment.
5) to eliminate intraprocedural X-ray imaging
6) to demonstrate the feasibility of the robotic implementation of SHD percutaneous treatments with current transcatheter technologies.
ARTERY can impact the widespread of SHD percutaneous treatments. Of note, despite being conceived to provide an alternative to high-risk patients, percutaneous treatments of SHDs are becoming a valid alternative to classic open-chest surgery also for moderate- and even low-risk patients, in that, these procedures i) have proven non-inferior or even superior to open-chest surgery in terms of effectiveness and freedom from adverse events, ii) avoid the risks associated to cardio-pulmonary bypass, iii) allow for shorter hospitalization time and much faster patient recovery. These factors, together with the lower rate of rehospitalization, make SHD percutaneous treatments cost-effective in different continents and healthcare systems, and in some cases even cost-saving and profitable to hospitals.
ARTERY can also impact the robotic surgery market. A 9.7% growth of the global surgical robotics market is expected in the next 5 years, due to the increase in patient demand for minimally invasive treatments and standardized surgeries, and in need for flexibility and precision in the operating room. According to the Economics Times, interventional cardiology is rated as only 5% of the global surgical robotics in 2016 and it will grow to only 6% in 2025, a relatively small market as compared to the incidence of cardiovascular diseases. In the light of the market projection relative to SHD devices, it is credible that, while examples of robotic systems are present (e.g. Sensei X, CorPath GRX), there is still room to open-up a barely scraped market for robotic devices, provided that disruptive technologies are developed. Moreover, IP ownership and market are dominated by the USA, thanks to the early investments that provided an extensive patent portfolio, early adoption, and doctors/patient acceptance of such technologies. ARTERY-related new technology and IP are expected to help balancing the market of surgical robotics toward Europe.