Modular robotic system with suspended actuators for endovascular catheter and guidewire navigation

Abstract

A robotic system for endovascular procedures is disclosed, comprising an inclined rail (2) towards the patient, to which multiple modular robotic actuators (RA) are suspended in a Master–Slave configuration and mounted on carriages (S1, S2, S3, S4...). Each RA is reusable, while dedicated disposable modules are attachable to the actuators to directly engage commercially available catheters and guidewires of different diameters and types, including guidewires with steerable cores, fixed hemostatic valves, and, in future applications, actively steerable catheters with one or two degrees of freedom and rotating hemostatic valves. S1 is an RA2 configured for catheter advancement and rotation; S2 is an RA4, RA5 or RA6 configured to hold and rotate a hemostatic valve, advance the catheter at the same speed as S1, and drive a steerable guidewire; S3 is a configurable RA for additional guidewires or catheters, including active ones; S4 is an RA2 placed at a fixed distance from S1, driving the synchronous translation of S2 and S3 with respect to S1 via toothed belts or equivalent gear systems. The system is managed by an electronic control unit connected via wired or wireless network, preferably through a serial protocol such as RS485, with galvanic isolation and synchronized with supervisory and data-recording software. Optional modules include force sensors, artificial intelligence for pre-operative planning, and integration with in vitro patient simulators for training and validation.

Description

MODULAR ROBOTIC SYSTEM WITH SUSPENDED ACTUATORS FOR ENDOVASCULAR CATHETER AND GUIDEWIRE NAVIGATION

[0001] The present invention relates to a robotic system for assisted endovascular navigation, equipped with multiple mechanical actuators, also containing optical sensors, connected via RS485 to a Master computer that, through two joysticks, allows the surgeon to manage, monitor, and record the surgical procedure in real time. The solution is particularly suited for complex procedures, such as access to cerebral vascular structures.

[0002] Currently available robotic systems provide only limited intra-operative feedback and lack precise measurement of the position of endovascular devices. Most systems do not integrate reliable angular sensors, nor do they allow accurate measurement of catheter insertion depth relative to known reference points. Furthermore, complete documentation of the procedures—covering images, forces, and video data—is either absent or non-standardized.

[0003] The present invention introduces a set of innovative solutions to simplify and extend the functionalities of the ROSES robotic system. In particular:

[0004] the inversion of the rail and actuator configuration, which reduces the distance from the patient and simplifies the creation of a sterile field;

[0005] new motion modules for catheters and guidewires, including microcatheters intended for the intracranial circulation, prepared for future control by artificial intelligence systems;

[0006] centralized management that records all procedural parameters in real time, enabling integration with decision-support algorithms;

[0007] an in-vitro patient simulator with a motorized camera, useful both for training in the use of the ROSES system and for education in manual catheter manipulation.

[0008]

[0009] Presently few are the robots in use for endovascular surgery, and are limited to peculiar fields. None is able to help in every part of the human body, and in particular none is able to separate the doctor from the patient in brain procedures, that also require bigger radiation doses.

[0010] The majority of the operators work manually, which forces them to receive continue doser of radiation, and even if they wear special aproms, with led to repair them from irradiations these aproms are so heavy that they end up causing spine problems.

[0011]

[0012] The present invention introduces a set of innovative solutions to simplify and extend the functionalities of the ROSES robotic system. In particular:

[0013] the inversion of the rail and actuator configuration, which reduces the distance from the patient and simplifies the creation of a sterile field;

[0014] new motion modules for catheters and guidewires, including microcatheters intended for the intracranial circulation, prepared for future control by artificial intelligence systems;

[0015] centralized management that records all procedural parameters in real time, enabling integration with decision-support algorithms;

[0016] an in-vitro patient simulator with a motorized camera, useful both for training in the use of the ROSES system and for education in manual catheter manipulation.

[0017] Main advantages are:

[0018] the fact that it allows separation of doctors from patients during the entite surgery;

[0019] The possibility of conducting procedures in any portions of the human body, including the brain;

[0020] The possibility of recording the entire procedures coupling the information about catheter and guidewires advancement, forces opposed by the body to penetration, and images, all in one record, which becomes a kind of black box of the surgery

Claims

.A robotic system for endovascular procedures, comprising an inclined rail towards the patient on which multiple modular robotic actuators (RA) are suspended and mounted on carriages (S1, S2, S3, S4, …) in a Master–Slave configuration, each RA being a reusable unit configurable with 2–6 degrees of freedom, and operable with a set of sterile disposable modules mechanically coupled to the RA’s motors for direct interaction with catheters and guidewires of variable diameters and types, including steerable guidewires with movable cores, fixed hemostatic valves, and, in future configurations, animated catheters with one or two curvature degrees of freedom and rotating hemostatic valves.S1 is an RA2 configured for catheter advancement and rotation; Wherein:S2 is an RA4, RA5 or RA6 configured to hold and rotate a hemostatic valve, advance the catheter at the same speed as S1, and optionally drive a steerable guidewire or animated catheter;S3 is a further RA with variable configuration (2–6 DoF), usable for additional catheters or guidewires, including micro-catheters for cerebral access;S4 is an RA placed at a fixed distance from S1 and configured to move S2 and S3 along the rail by means of toothed belts, optionally housing an internal gear train.The system of claim 1, wherein each RA is reusable and non-sterile, and the sterile barrier is ensured by disposable sterile bags and protective plates covering the motorized mechanisms, combined with the disposable or re-sterilizable modules for direct actuation of catheters and guidewires.The system of claim 1, wherein each RA is reusable and non-sterile, and the sterile barrier is ensured by disposable sterile bags and protective plates covering the motorized mechanisms, combined with the disposable or re-sterilizable modules for direct actuation of catheters and guidewires.The system of any preceding claim, wherein, to transmit the same rotation to S1 and S2, since both are engaged with the same catheter, the rotation is replicated mechanically or electronically in a synchronous manner, maintaining alignment during all stages of the procedure..The system of any preceding claim, wherein a rotating hemostatic valve is connected at the outlet of the RA to which the catheter is attached, said valve being actuated exclusively by the operator through an external manual control, independently from the RA’s motorized functions.The system of any preceding claim, wherein a disposable module for steerable guidewires comprises a driving wheel, a spring-loaded deflector for insertion of the guidewire into an internal cavity of a driven wheel, and a locking screw, such that the inner core of the guidewire can be wound and unwound independently from its external body, which is fixed near the entry point of the deflector.The system of any preceding claim, wherein the control software is integrated with arti.ficial intelligence algorithms to analyze pre-operative 3D angiographic data, identify the optimal path, and automatically guide catheters and guidewires along the reconstructed vascular lumen.The system of any preceding claim, comprising a set of force sensors mounted on the Master side of the inclined rail, connected in parallel with a counterweight to compensate for the system’s weight and increase sensitivity in detecting forces exerted by the patient’s body