SIMULADOR DE BANCADA PARA INTERVENÇÃO CORONARIANA PERCUTÂNEA COMPLEXA GUIADA POR ULTRASSONOGRAFIA INTRAVASCULAR

Description

1 / 8 Benchtop simulator for complex percutaneous coronary intervention guided by ultrasound. INTRAVASCULAR Technological sector of invention

[001] The present invention belongs to the field of biomedical engineering and medical training devices, and refers, more specifically, to a modular benchtop simulator developed for the practical training of complex percutaneous coronary interventions guided by intravascular ultrasound (IVUS). State of the art

[002] The practical training of interventional cardiology professionals, especially in the context of complex percutaneous coronary procedures, represents a significant technical challenge today. Such procedures, which include the management of calcified atherosclerotic lesions, coronary bifurcations, and the use of specific tools such as cutting balloons, rotational atherectomy devices, and intravascular lithotripsy systems, demand a high degree of precision, dexterity, and technical knowledge. Furthermore, the increasing adoption of intravascular ultrasound (IVUS) as an imaging tool for guidance and detailed diagnosis necessitates prior familiarization with the equipment and its interpretation in the clinical context. However, professionals in training face serious limitations regarding the safe practice of these procedures in a controlled environment.

[003] In the state of the art, attempts to address this challenge are observed through physical or virtual simulators applied to cardiovascular intervention training. Among the best-known commercial examples are the VIST™ device from Mentice, the ANGIO Mentor™ from Simbionix, and the CathLabVR from CAE Healthcare. These simulators present advanced simulation structures, with interactive modules and digital integration aimed at replicating diverse clinical scenarios. However, such models are still limited to predominantly virtual simulations or configurations that do not fully integrate. Petition 870250066795, dated 07 / 31 / 2025, page 9 / 24 2 / 8 real medical devices, nor do they allow functional connection with clinical IVUS systems, which compromises the plausibility of the training experience. Furthermore, these systems are often robust, difficult to transport, and require complex infrastructure, limiting their application in smaller educational environments or decentralized training.

[004] A partial exception is represented by the HEARTROID™ model, which allows the use of catheterization devices in real size and functionality, providing greater fidelity to technical handling. However, the system still has limitations regarding portability and ease of configuration, being based on a structure with a propulsion pump, which makes it impractical for use on a bench or transport to different teaching locations.

[005] In addition to commercial simulators, the state of the art includes patent document MU8801696-0, which describes a training mannequin for therapeutic skills, intended to train professionals in procedures applicable to trauma patients. Although this document belongs to the field of medical simulation, it is a solution aimed at a completely different audience and purpose, without any integration with intravascular systems or emphasis on interventional cardiology, which demonstrates its low relevance to the problem addressed here.

[006] Given this scenario, a significant technical gap is evident in the availability of compact, modular, and realistic benchtop simulators that allow the use of full-size interventional devices and effective integration with IVUS clinical systems. A solution is lacking that combines portability, anatomical and functional accuracy, reproducibility of complex clinical scenarios, and compatibility with devices used in hospital practice. This deficiency compromises the quality of training, the safety of procedures, and the training time for professionals. New features and objectives of the invention.

[007] The present invention aims to provide a benchtop simulator for complex percutaneous coronary intervention guided by ultrasound. Petition 870250066795, dated 07 / 31 / 2025, page 10 / 24 The 3 / 8 intravascular (IVUS) simulator was developed to fill existing gaps in the practical training of advanced endovascular procedures. It is a modular simulator designed to enable clinical practice with real medical devices in a safe, controlled environment with high anatomical and functional fidelity. The system was specifically designed to integrate with IVUS clinical consoles, allowing the generation of realistic images from the insertion of catheters and guidewires into anatomical models that simulate coronary artery disease with specific characteristics.

[008] The simulator structure comprises a base representing the human body and arterial system, including sealed peripheral channels through which the femoral and radial arterial pathways to the aorta can be simulated. In the center of the structure, a connector links these peripheral channels to a thoracic chamber, also optionally sealed for fluid filling, where different interchangeable anatomical models of coronary arteries—anterior descending, circumflex, and right—are attached. These models simulate various clinical conditions, such as bifurcations, calcified lesions, and atherosclerotic narrowings of varying severity, allowing the practice of techniques such as lesion dilation, stent implantation, access and removal maneuvers for devices, and the use of specific tools such as cutting balloons, rotational atherectomy (Rotablator®), and intravascular lithotripsy.

[009] The novelty of the invention lies in its ability to combine, in an unprecedented way, portability, modularity and real integration with intravascular imaging systems. By allowing the insertion of devices at real scale and operation, and direct coupling with clinical IVUS consoles, the simulator offers a highly realistic practical experience. Unlike models available in the prior art, the present simulator does not depend on proprietary software, does not require robust infrastructure, nor is it limited to computational representations or static models. Its compact construction and ease of assembly allow its use in different environments, including educational contexts with limited resources. Petition 870250066795, dated 07 / 31 / 2025, page 11 / 24 4 / 8

[010] Furthermore, the modularity of the system allows for the rapid replacement of anatomical models, enabling the instructor or user to simulate different clinical conditions sequentially, without the need for complex disassemblies. Compatibility with other imaging technologies, such as optical coherence tomography (OCT), further expands the applicability of the device in training for image-guided intravascular interventions.

[011] In this way, the invention enables the safe and effective development of the skills necessary to perform complex percutaneous coronary interventions, eliminating the risks inherent in direct training on patients and solving deficiencies identified in conventional simulators. By enabling high-quality, realistic and accessible practice, the simulator contributes significantly to the technical improvement of interventional cardiology professionals. Description of the attached figures

[012] In order for the present invention to be fully understood and put into practice by any technician in this technological sector, it will be described in a clear, concise and sufficient manner, based on the attached figures, which illustrate and support it, listed below: Figure 1 represents a perspective view of the benchtop simulator; Figure 2 represents a top view of the benchtop simulator, without the cell phone holder; Figure 3 represents a top and front view of the arterial support of the benchtop simulator; Figure 4 represents the main lesions in the arteries, being fibrolipid (a), calcified (b) and lipid (c); Figure 5 shows a photograph of the simulator, highlighting the anterior descending artery and diagnostic guide. Petition 870250066795, dated 07 / 31 / 2025, page 12 / 24 5 / 8 Detailed description of the invention.

[013] As shown in Figures 1 to 3, the benchtop simulator for complex percutaneous coronary intervention comprises a base structure consisting of a sealed lower tank (01), which constitutes the main support for the body of the simulator. On this base, a support tower (23) is mounted in a slot, to which a bracket (24) is attached for stabilizing an elevated base (25) configured to support an optical device, such as cameras or cell phones.

[014] In the central portion of the simulator there is a plate (05) provided with a simulated vessel model (06), in which the interchangeable anatomical model of the coronary artery (07) is installed. This model includes the main branch of the simulated anterior descending artery (08), as well as lateral branches — the first diagonal branch (09) and the second diagonal branch (10) —, with specific emergence angles. Along the path, simulations of atherosclerotic plaques in different stages and severities are arranged, including plaques with fibrolipid lesions (11), calcified (12) and lipid (13).

[015] The upper part of the structure (01) includes a connector interface (04), which promotes the union between the radial (03) and femoral (22) access channels and the central chamber of the simulator (06). Communication with the peripheral arterial system is made through simulated channels (02), which represent, among others, the radial, brachial, axillary and subclavian arteries. These channels are accessed by valved interfaces, for the right upper limb (03), and for the right lower limb (22), enabling the insertion of real medical devices via the radial or femoral route.

[016] The structure also includes segments of other major arteries, such as the right carotid (17), the left carotid (18), the left subclavian (19), the left femoral (15) and the right femoral (16), allowing modular construction and coupling of different anatomical pathways according to the desired training.

[017] Anatomical models of coronary arteries (08)(09)(10) are made of silicone tubing or translucent flexible material, simulating the elastic properties of human coronary arteries. Anatomical models of Petition 870250066795, dated 07 / 31 / 2025, page 13 / 24 6 / 8 coronary arteries (08)(09)(10) can be fixed inside the thoracic chamber (06) using clips (14). The anatomical models of the left (anterior descending and circumflex) and right coronary arteries may present different branches with various angulations, calibers and courses, such as: a greater or lesser number of lateral segments (diagonal and marginal).

[018] As shown in Figure 4, the various plaques represent three atherosclerotic lesions at different stages of severity and with content characteristics similar to those of lipid (a), fibrolipid (b) and calcified (c) plaques, which correspond to the three main forms of lesions in arteries.

[019] The simulated anatomical radial and femoral artery pathways are fixed at the ends to the silicone valves (03)(22), through the opening and at the free end, there is an orifice for proximal insertions compatible with introducer sheaths for the use of the respective real IVUS catheters and other devices for rotational atherectomy, intravascular lithotripsy, optical coherence tomography (OCT) catheters, balloons, guidewires, angioplasty catheters and commercial stents.

[020] Optionally, the valves (03)(22) will be equipped with a channel for contrast injection for optical coherence tomography (OCT) to perform, allowing simultaneous use of other imaging methods.

[021] Actual IVUS devices consist of a tubular catheter, equipped at the front end with an image acquisition device analogous to a high-resolution microcamera, which is connected to an automatic retraction module for image acquisition, which is connected to its own console containing an image processor that transmits the images to an electronic device with an attached monitor (console).

[022] The benchtop simulator has the functionality of real-time monitoring of the entire simulated procedure by means of a support system for common mobile devices / tablets with a camera (not included in the simulator) attached to the simulator and which, through a connection of this mobile device via high-definition video input (HDMI), connects to a television. Petition 870250066795, dated 07 / 31 / 2025, page 14 / 24 7 / 8 common, allows the operator of the simulated procedure to follow the entire procedure in real time with video images.

[023] With the benchtop simulator thus obtained, its use in practical training of complex percutaneous coronary interventions guided by intravascular ultrasound (IVUS) becomes simple and efficient. The user selects the anatomical models according to the type of training desired (from the lesion (11), (12) or (13)) and installs them in the base structure (01), which is then filled with fluid (water or physiological solution - NaCl 0.9%) by the rib cage (06). Real catheters, balloons, stents and guidewires are introduced through a simulated access via the valve (03) or (22), representing the radial or femoral route, respectively. The real clinical IVUS unit (console) is connected to the system, allowing the planning, navigation and execution of the procedure.Optionally, placed on the support (23), an external camera, such as a cell phone camera, can be used to clearly record the entire procedure, offering instant visual monitoring to the operator and enabling the recording of the steps for educational purposes.

[024] For example, Figure 5 illustrates the benchtop simulator focusing on the anterior descending artery represented inside the thoracic chamber (06), connected to the anatomical pathway that simulates the central arterial system. The introduction of a diagnostic guidewire via the radial route (03) through the arterial canal (02) is observed, which follows the vascular pathway until it reaches the simulated coronary artery (08). The system's layout allows navigation of the guidewire from the peripheral access point to the coronary region, realistically reproducing the typical clinical pathway used in percutaneous coronary interventions.

[025] It is important to emphasize that the figures and descriptions provided do not limit the ways in which the inventive concept proposed herein can be implemented, but rather illustrate and make understandable the conceptual innovations revealed in this solution. Thus, the descriptions and images should be interpreted in an illustrative and not limiting way, and other equivalent or analogous forms may exist. Petition 870250066795, dated 07 / 31 / 2025, page 15 / 24 8 / 8 of the implementation of the inventive concept now revealed, and which do not deviate from the protection scope outlined in the proposed solution. Petition 870250066795, dated 07 / 31 / 2025, page 16 / 24

Claims

1 / 2 CLAIMS 1- BENCH SIMULATOR FOR COMPLEX PERCUTANEOUS CORONARY INTERVENTION GUIDED BY INTRAVASCULAR ULTRASOUND, characterized by comprising a base structure (01) composed of a sealed lower tank, and on this base, a support tower (23) is mounted in a slot, to which a bracket (24) is associated for stabilizing an elevated base (25); in the central portion there is a plate (05) provided with a simulated vessel model (06), in which the interchangeable anatomical model of the coronary artery (07) is installed, this model includes the main branch of the simulated anterior descending artery (08), as well as lateral branches — the first diagonal branch (09) and the second diagonal branch (10) —, with specific emergence angles; Along the route, simulations of atherosclerotic plaques are displayed at different stages and levels of severity, including plaques with fibrolipid lesions (11), calcified (12) and lipid lesions (13);The upper part of the structure (01) includes a connector interface (04) for joining the radial (03) and femoral (22) access channels and the central chamber (06); communication with the peripheral arterial system is made through simulated channels (02), which represent, among others, the radial, brachial, axillary and subclavian arteries; these channels are accessed by valved interfaces, for the right upper limb (03), and for the right lower limb (22), for insertion of real medical devices via radial or femoral access; the structure (01) also includes segments of other major arteries, such as the right carotid (17), the left carotid (18), the left subclavian (19), the left femoral (15) and the right femoral (16). 2- SIMULATOR, according to claim 1, characterized by the anatomical models of coronary arteries (08)(09)(10) being made of silicone tubes or translucent flexible material, simulating elastic properties of human coronary arteries; and also being able to be fixed inside the thoracic chamber (06) by means of clips (14). Petition 870250066795, dated 07 / 31 / 2025, page 17 / 24 2 / 2 3- SIMULATOR, according to claim 1, characterized by the simulated anatomical paths of radial and femoral arteries being fixed at the ends to the silicone valves (03)(22), through the opening and at the free end, provided with an orifice for proximal insertions compatible with introducer sheaths for the use of the respective real IVUS catheters and other devices for rotational atherectomy, intravascular lithotripsy, optical coherence tomography (OCT) catheters, balloons, guidewires, angioplasty catheters and commercial stents. 4- SIMULATOR, according to claim 1, characterized in that the valves (03)(22) are optionally equipped with a channel for contrast injection. 5- SIMULATOR, according to claim 1, characterized by optionally having an external camera, such as that of a mobile device, on the support (23) to record the procedure. Petition 870250066795, dated 07 / 31 / 2025, p. 18 / 24

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