Medical simulation and validation device

Abstract

The invention relates to relates to a medical simulation and validation device, along with a method for simulation, a computer program product, and a simulation system for the simulation of endovascular procedures, serving both as a training tool for medical practitioners and as a platform fortesting and validating medical devices used in such procedures. The simulation and validation device, together with the associated method, program, and system, are designed to accommodate a broad range of vascular models while delivering a high-contrast visual imaging solution across a spectrum of wavelengths.

Description

[0001] MEDICAL SIMULATION AND VALIDATION DEVICE

[0002] TECHNICAL AREA

[0003] The present invention relates to a medical simulation and validation device, along with a method for simulation, a computer program product, and a simulation system for the simulation of endovascular procedures, serving both as a training tool for medical practitioners and as a platform fortesting and validating medical devices used in such procedures. The simulation and validation device, together with the associated method, program, and system, are specifically designed to accommodate a broad range of vascular models while delivering a high-contrast visual imaging solution across a spectrum of wavelengths.

[0004] STATE OF THE ART

[0005] Endovascular interventions are minimally invasive procedures used to diagnose and treat conditions affecting blood vessels, such as aneurysms, stenosis, or occlusions. These procedures often involve the insertion and navigation of specialized medical instruments, such as catheters, guidewires, and stents, within the intricate vascular network of the human body. By leveraging imaging techniques like ultrasound, fluoroscopy, MRI or angiography, medical practitioners can monitor and guide these interventions with precision, minimizing risks and improving patient outcomes. Endovascular interventions play a critical role in modern medicine, offering effective alternatives to traditional open surgery with reduced recovery times and lower complication rates.

[0006] To perform these minimally invasive and complex procedures, practitioners rely on an array of medical devices designed for precise navigation and treatment within the vascular system. These devices are developed to meet stringent standards for safety, compatibility, and usability in clinical settings. Training on such interventions requires simulation systems that closely replicate real-world conditions, enabling practitioners to gain proficiency in navigating delicate vascular structures and deploying medical devices effectively. The development phase of medical devices supporting minimally invasive endovascular procedures also benefit from simulation systems to provide critical environments fortesting a range of normal and worst-case scenarios. The feedback gained during the initial development phase is essential in validating the functionality of new devices, ensuring their compliance with regulatory standards and readiness for clinical application.

[0007] Given the complexity and precision required in vascular interventions, effective training and device validation demand simulation systems that replicate real-world conditions as closely as possible. These systems must enable practitioners and device developers to navigate the intricacies of vascular anatomy while accommodating diverse procedural scenarios. High-quality imaging, compatibility with a wide range of vascular models, and realistic physiological simulations are critical features for ensuring the effectiveness of these training and testing platforms.

[0008] Several approaches to vascular simulation have been proposed to address these needs. While advancements like enclosed simulation devices and contrast-enhancing solid blocks have provided incremental improvements, they remain limited in scope, especially in early or initial design development stages. Current solutions, as outlined in prior art, either fail to achieve high-contrast visualization using optical methods or lack the modularity and adaptability required for diverse vascular anatomies and clinical use cases. These limitations underscore the need for a more flexible and universal simulation system, as detailed in the following review of the state of the art.Patent application WO2017190732A1 describes an enclosed simulation device featuring a three-dimensional vascular surgical simulation model within a container designed to collect the outflowing liquid from the vascular model. While the invention incorporates a transparent container, it is not optimized for high-contrast visualization using optical sensors, which limits its effectiveness in simulating realistic imaging conditions & device interaction during execution required for endovascular interventions.

[0009] Patent application US20230245592A1 discloses a medical simulation device that integrates a vascular simulation model within an enclosed container, employing a solid block, such as one made from cast resin, to enhance contrast for imaging. However, this approach significantly restricts the device's compatibility and flexibility, as the solid block limits the interchangeability of vascular simulation models and fails to accommodate the wide variety of vascular anatomies necessary for comprehensive training and device testing.

[0010] Patent application DE102015011062A1 discloses a device designed for visual flow analysis in transparent vascular models. The vascular models are perfused with a glycerin solution that mimics the viscosity of blood and contains reflective polymer particles. A light field camera captures the reflections of these particles, enabling the analysis of flow patterns and their alteration by medical devices such as coils, stents, or flow diverters. While this device provides valuable insights for optimizing interventions, it is limited to flow visualization and does not support realistic training scenarios using actual medical instruments. Furthermore, it lacks compatibility with modular or interchangeable vascular models and does not provide comprehensive simulation environments for medical training or device validation.

[0011] Patent publication US 5,638,819 A describes a system for navigating and localizing rigid medical instruments, such as biopsy needles or endoscopes, within a patient. The system uses sensors attached to the instrument to determine its position relative to a reference coordinate system, which is then superimposed on tomographic or live video images. While effective for rigid instruments, this system is unsuitable for simulating flexible vascular devices like catheters or guidewires. Its focus on localization rather than realistic training or procedural simulation further limits its applicability in the context of vascular interventions. Additionally, it does not address compatibility with diverse vascular anatomies or the need for a certifiable and controlled training environment.

[0012] OBJECT OF THE INVENTION

[0013] A key challenge with existing medical simulation devices, particularly for endovascular and / or vascular interventions, lies in their inability to create realistic and versatile training and validation environments. In current practice, medical professionals rely heavily on X-ray fluoroscopy and at times MRI to control and monitor interventions in all endovascular procedures. These imaging methods typically require practitioners to view the procedure on a screen with specific resolution and contrast. However, many available solutions are limited to specific models or enclosed spaces monitored by X-rays, exposing users to harmful and undesirable radiation.

[0014] Moreover, existing simulation devices lack compatibility with the wide variety of vascular systems encountered in clinical practice. There is no universal system that provides a controlled, certifiable environment for both medical training and device development. For medical device developers, the shortcomings are even more pronounced, as current solutions fail to generate reproducible records, direct feedback on device interaction during use and sufficient unbiased data for certification and validation purposes.Another significant concern is the susceptibility of existing systems to manipulation and environmental noise, which undermines the integrity of visual feedback, training and testing processes. A robust solution must incorporate features that prevent or at least significantly obstruct unauthorized alterations and noise reduction which benefits in valuable device performance and development feedback.

[0015] Therefore, there is a pressing need for a simulation system that is compatible with diverse vascular models, easy to use, highly flexible, and capable of providing a controlled, certifiable, and manipulation-resistant environment for medical practitioners and device developers alike.

[0016] SOLUTION

[0017] The problem underlying the present invention is solved by a medical simulation and validation device for simulating endovascular interventions and testing medical devices for such interventions according to claim 1.

[0018] Furthermore, the present invention solves the problem by providing a computer program product according to claim 25, a method according to claim 23, and a simulation system according to claim 20.

[0019] Further advantageous embodiments can be found in the subclaims, the description and the embodiment examples.

[0020] GENERAL ADVANTAGES

[0021] The present invention addresses several critical shortcomings identified in existing medical simulation devices and provides significant improvements over the state of the art. Current simulation devices fail to replicate the realistic working environment of medical practitioners, offering limited utility as training tools or as platforms for the testing and certification of new medical devices. Many existing solutions are restricted to specific vascular models, lacking the flexibility required for generalized applications. In contrast, the disclosed invention introduces a versatile approach that supports high-contrast imaging and multiple simulation modes, ensuring compatibility with a wide variety of vascular models, essential early phase development feedback and use cases, such as realistic practitioner training and rigorous certification processes for new medical devices.

[0022] Moreover, most existing solutions rely on X-ray imaging, exposing medical device engineers, trainees and testing personnel to harmful radiation and often failing to generate data optimized for certification and post-market surveillance requirements. By eliminating the need for X-ray devices, the present invention offers a radiation-free environment, significantly enhancing safety and accessibility for prolonged training sessions and validation tasks.

[0023] A key advancement of the invention lies in its ability to simulate X-ray fluoroscopy images using a high-precision processing unit. These simulated images are displayed in real time on either local or spatially separated screens, providing superior image quality and detail compared to traditional methods. This combination of realistic simulation, radiation-free operation, and compatibility with diverse vascular models establishes the invention as a groundbreaking solution for both training and validation in the medical field.

[0024] Furthermore, the present invention is specifically designed to support comprehensive bench top testing, allowing medical device developers to evaluate and compare new products against existing predicate devices under highly controlled conditions. By providing a consistent and repeatable testing environment, the invention ensures that regulatory bodies and manufacturers alike can rely on robust, data-driven evidence to streamline the certificationprocess for novel endovascular devices. Comparative predicate device bench top testing with standardized conditions can be used in the certification process as required by some medical approval bodies such as the U.S. Food and Drug Administration (FDA) or the EU European Medicines Agency (EMA).

[0025] In addition, the invention’s robust architecture greatly facilitates fault analysis when devices are returned for investigation. The ability to closely and reproducibly monitor and record device performance within the simulation not only aids in determining whether the product remains within acceptable tolerances but also provides essential insights for continuous product improvement and post-market surveillance.

[0026] DETAILED DESCRIPTION

[0027] The invention relates to a medical simulation and validation device (1.0) for simulating vascular interventions and testing medical devices for such interventions, wherein the device (1.0) comprises or consists of

[0028] - an enclosed housing (1.1), wherein the enclosed housing preferably blocks 90.0% to 99.9% of external UVA / IS radiation, as determined using a photodetector, comprising a first housing part (1.2) and a second housing part (1.3), connected by a hinge-like element (1.4) and secured by a locking element (1.5), preferably additionally comprising a sealing element arranged between first and second housing (1.2, 1.3);

[0029] - a vascular model support (2.1 ) for arranging and fixing a transparent vascular model (2.0), comprising at least a fluid access port (2.2) and at least a device access port (2.3) for medical devices; wherein the fluid access port (2.2) the device access port (2.3) are preferably arranged on the housing and / or the vascular model support, depending on an internal or external fluid pump (8.0) and fluid reservoirs (8.1) arrangement, - a high-contrast visualization system (3.0), comprising or consisting of at least an optical imaging device (3.1), preferably arranged on a kinematic system (3.5), and a light source (3.2), wherein the light source (3.2) is preferably arranged on the bottom of the second housing, preferably at least a VIS light source, wherein the optical connected to a processing unit (4.0) with a data storage unit (4.1);

[0030] - wherein at least one dispersion element (3.3) is placed between a light source and the vascular model support (2.1), and wherein the optical imaging device (3.1) is arranged in an incidence angle (3.4) of 0° to 80° to the plane of the dispersion element (3.3);

[0031] - a communication unit (5.0) connected to the processing unit (4.0), for transmitting optical imaging data collected from the high-contrast visualization system (3.0) and preferably further experimental data, selected from the list comprising or consisting of pressure data, temperature data, metainformation data, such as time, date, duration, experiment ID and operator, or a combination thereof;

[0032] - a power delivery and distribution system (6.0),

[0033] wherein the simulation device (1.0) is connected to at least a screen (7.0) via the communication unit (5.0), which screens a high contrast image or simulated intervention image provided by the visualization system (3.0), and wherein at least the vascular model (2.0), the vascular model support (2.1 ), the contrast visualization system (3.0) and dispersion element (3.3) are arranged fully within the housing (1.1),

[0034] wherein the high contrast live image is selected from the list comprising or consisting of X-ray fluorescence simulation live image, colored high-contrast live image, UV-fluorescence live image, real color high-contrast live image. This advantageously allows for an adaptable, cross-model compatible training system, wherein most available transparent vascular models may be integrated. The synergistic effect from the special illumination arrangement with the integrated computational parts allow a live image to be broadcast to a screen, which mimics the operational situations for medicinal practitioners.In the context of the current invention, an "enclosed housing" refers to the protective outer shell of the simulation and validation device, which encapsulates and isolates the internal components. This housing is specifically designed to block between 90.0% and 99.9% of external UV / VIS radiation, as determined using a photodetector. Its primary purpose is to create a controlled environment for high-contrast visualization and simulation while preventing external light interference. The enclosed housing ensures both operational stability and safety for the internal systems during use. Furthermore, it allows for easy and safe transport.

[0035] In some preferred embodiments, the enclosed housing is designed to replicate various anatomical regions of the human body, enabling the realistic simulation of complex and tortuous anatomical pathways. This enhances the training experience by providing a lifelike environment for medical device insertion and navigation. To further increase realism, gelatinous and / or biomimetic materials, as well as synthetic bones, may be arranged on or within the enclosed housing to enhance the training or validation conditions.

[0036] The "first housing part", preferably referring to the top housing part, and "second housing part", preferably referring to the bottom housing part, are structural components of the enclosed housing, which collectively define its overall form and functionality. These two parts are interconnected with a hinge-like element to allow access to the internal components when separated and provide a secure, sealed enclosure when joined. The connection between the first and second housing parts ensures ease of maintenance, assembly, and disassembly while maintaining the integrity of the controlled environment within the housing.

[0037] Preferably, the first housing part may comprise visual elements, such as a control screen, information display or advertisement. In some preferred embodiments, the information display can be designed as a lettering and / or as a logo, whereby the operating mode is indicated by a change of color, for example from green to red, from ready for operation to in operation.

[0038] In some preferred embodiments, the enclosed housing, particularly the first and second housing parts, comprises or consists of sections that are transparent or semi-transparent to X-ray radiation. This design enables the use of the medical testing device in X-ray and / or CT imaging environments, facilitating enhanced testing and validation under realistic clinical conditions. Preferred materials for the enclosed housing, particularly the first and second housing parts, in this embodiment are selected from the list comprising or consisting of wood, plywood, plastic, especially polymethyl methacrylate (PMMA), polycarbonate (PC), or polyethylene (PE), carbon fiber, fiber composites, ceramics, composite materials.

[0039] In some preferred embodiments, the second housing part, herein the underside, is designed to be waterproof. This ensures protection against accidental spills and enables the underside to function as a container or reservoir. The full volume of the underside can be utilized to hold a thermally controlled heating fluid, ensuring that the vascular model is maintained at physiological temperatures, preferably in the range of 35 to 45°C, more preferably in the range between 37 and 40°C, as measured by a thermometer. This feature enhances the realism of training and validation scenarios by replicating the thermal conditions of the human body.

[0040] In a preferred embodiment, the enclosed housing further includes a ventilation element to manage gas exchange and humidity removal. This feature addresses the potential buildup of humidity at elevated temperatures, such as 35 to 45°C, which are often used to simulate physiological conditions. Excess humidity at these temperatures can result in fogging and a deterioration of imaging quality, which the ventilation element is specifically designed toprevent. The ventilation element may be active or passive. Active systems include components such as fans or conditioning units that may optionally regulate the internal temperature of the enclosed housing. Passive systems rely on strategic ventilation paths or materials that facilitate natural air exchange. Regardless of the mechanism, the ventilation element is designed to ensure that no external light or ambient noise is introduced into the system. To achieve this, it is equipped with sealing mechanisms or arranged in a geometrically optimized manner that preserves the light-tightness of the housing. The ventilation element is preferably positioned in the first housing part (upper housing part), particularly in embodiments where the device and housing are designed to be liquid-tight to prevent spillage. This arrangement not only protects the internal components but also ensures effective humidity and temperature control without compromising the overall functionality or integrity of the system.

[0041] In some preferred embodiments, the first housing part and second housing part may be supported by a hydraulic element or hydraulic hinge, which enables a semi opened state and controlled closing. This reduces the risk of accidental injury while closing the device and quick access options as needed.

[0042] In some preferred embodiments the enclosed housing preferably blocks 90.0% to 99.9% of external UVA / IS radiation, as determined using a photodetector. This allows the best conditions for imaging and ambient noise reduction, which reduces the contrast and visualization quality.

[0043] In some embodiments, the enclosed housing includes a sealing element positioned between the first and second housing parts, further enhancing the blockage of UVA / IS radiation and, optionally, IR radiation. The sealing element is preferably selected from mechanically compressed components, such as rubber or silicone seals, or mechanical constructions, such as indentations or overlapping elements, designed to create a tight and durable seal. This configuration ensures optimal isolation of the internal environment from external light interference, contributing to the system's high-contrast imaging performance.

[0044] A "hinge-like element" is a mechanical joint that connects the first and second housing parts, allowing rotational movement between them while ensuring an enclosed space blocking outside radiation in the closed state. This element facilitates the opening and closing of the housing, enabling convenient access to the internal systems. In a preferred embodiment, the hinge-like elements are selected from a list comprising or consisting of pin hinges, barrel hinges, piano hinges, spring-loaded hinges, friction hinges, pivot hinges, butterfly hinges, hinge clamps, or rotational hinges with adjustable tension. These hinge-like elements provide flexibility in design, allowing the first and second housing parts to open and close smoothly while maintaining structural integrity and alignment.

[0045] In some preferred embodiments, the hinge-like element is designed as a quick release hinge, so that the first and second housing parts may be quickly completely separated for maintenance and access.

[0046] In the context of the invention, a "locking element" refers to a mechanism that secures the first and second housing parts in a closed position. The locking element ensures that the enclosed housing remains sealed during operation, preventing unintended openings and maintaining the integrity of the controlled environment. This element is preferably designed to be robust and easy to operate, offering both mechanical reliability and user convenience. In some preferred embodiments of the invention, the locking element is connected to a processing unit equipped with a data storage unit. Here, advantageously, the locking element can be automatically locked by a command send by the processing unit in specific use cases, such as in validation mode, where it is locked automatically to ensure compliance and voluntary or involuntary manipulation of the medical device

[0047] test / validation.In some preferred embodiments, the device further comprises sensors selected from the list comprising or consisting of temperature, pressure, magnetic field sensors. With these sensors, which are preferably connected to the processing unit, the device can collect further experimental data, selected from the list comprising or consisting of pressure data, temperature data, and magnetic field data. This allows for an improved validation or training system.

[0048] Furthermore, the simulation device includes a power delivery and distribution system, which is responsible for converting current and voltage from an external power source, such as a DC or AC power supply, into the specific current and voltage levels required by the individual components of the device. These components may include, but are not limited to, the processing unit, optical imaging devices, kinematic system, light sources, heating or cooling systems, fluid pump, and communication unit. The power delivery and distribution system ensure stable and efficient operation of all integrated systems. Preferably, the power distribution and delivery system provides additional power delivering units, such as USB A, B, C type power sockets, for quick connection of new optical imaging devices or other sensors.

[0049] Preferably, the power delivery and distribution system is fully enclosed within the housing, ensuring a compact and transportable design. This integrated configuration not only enhances the portability of the device but also protects the system from external influences, contributing to its durability and ease of use in various environments.

[0050] In the spirit of the current invention, a “screen” refers to a visualization component designed to display the processed output from the simulation device, including real-time or recorded images, data streams, or visualizations related to the vascular model and medical device interactions. The screen enables users to interact with and analyze the simulation, enhancing its utility for both training and validation purposes. The screen is preferably selected from the list comprising or consisting of LED screens, OLED screens, QLED screens, or advanced visualization systems, such as augmented reality (AR), virtual reality (VR), or extended reality (XR) systems.

[0051] In some embodiments, the screen is designed as an augmented reality (AR), virtual reality (VR), or extended reality (XR) system, which increases user immersion.

[0052] In some preferred embodiments, the screen is designed not only as a display device but also as an input interface, enabling users to send commands to the communication unit and adjust key parameters of the simulation device. These parameters may include the view angle of the optical imaging devices, fluid flow speed, or other operational settings. The screen is preferably selected from the list comprising or consisting of touch screens, screens with integrated input devices, such as controllers, keyboards, or trackpads, gesture recognition-enabled screens, screens with built-in acceleration sensors.

[0053] In some preferred embodiments, the screen is positioned in such a way relative to the simulation device that the user, preferably a medical practitioner, can simulate the physical distance typically encountered during a real intervention on a patient’s body. This setup replicates the procedural environment, allowing the practitioner to practice device handling and visualization under realistic conditions.

[0054] Alternatively, the screen can be located remotely to serve teaching and quality control purposes. This remote configuration allows supervisors, educators, or quality assurance professionals to monitor the simulation in real-time or review recorded sessions for feedback, training evaluation, or procedural validation. This dual-placement flexibility enhances the versatility of the simulation system for a variety of applications.

[0055] A “vascular model”, in the spirit of the current invention, refers to a representation of a biological vascular system, which may correspond to a portion of or the entirety of an organism's vascular structure, preferably that of a mammal, and most preferably a human. The vascular model is designed to be transparent or semi-transparent in at least the visible (VIS) spectrum and, preferably, in the ultraviolet (UV) and infrared (IR) ranges. It is typically fabricated from materials such as silicone, rubber, elastomers, or flexible polymers, and includes at least one fluid inflow and one fluid outflow. These are connected to the fluid access ports of the simulation device, enabling realistic blood flow simulations that replicate biological conditions.

[0056] In some preferred embodiments of the simulation device according to the current invention, the vascular model is selected from the list comprising or consisting of full human vascular model, cerebral vascular model, peripheral vascular model, major circulatory vascular model, or a combination of these.

[0057] In the spirit of the current invention, a vascular model support refers to a structural component designed to securely arrange and fix a transparent vascular model within the simulation device. The vascular model support provides a stable and precise platform that ensures the proper positioning and alignment of the vascular model, facilitating optimal imaging and simulation conditions. The vascular model support is preferably planar and equipped with fixing means specifically adapted for securing both flexible and inflexible transparent vascular models, thereby accommodating a wide variety of model designs and materials. These fixing means are preferably selected from a list comprising or consisting of loops, straps, mountings, hooks, and locking elements, ensuring secure attachment while allowing for easy installation and removal.

[0058] In some preferred embodiments, the vascular model support is transparent or semi-transparent, for at least the selected light source wavelength, enabling background illumination by the light sources in combination with the dispersion element. This transparency is critical for achieving high-contrast imaging conditions by allowing light to pass through the vascular model support, enhancing the visualization of the vascular model against the illuminated background.

[0059] The vascular model support preferably comprises at least one fixing unit for securing and positioning the vascular model. These fixing units are adapted to hold and fixate the vascular model while allowing for the arrangement of individual parts of the vascular model in a realistic manner to simulate biological analogues accurately.

[0060] The term “semi-transparent” refers to a material with a specific radiation transmittance of 30% to 90% per centimeter of material, more preferably 50% to 90%. The term “transparent” refers to a material with a radiation transmittance of 90% to 99.9% per centimeter of material, more preferably 95% to 99.9%, as determined by a transmission experiment using a light source and a light detector at the relevant radiation wavelength.

[0061] In the spirit of the current invention, the high-contrast visualization system refers to a synergistic arrangement of components designed to achieve exceptional imaging clarity by optimizing illumination and imaging conditions. The system synergistically combines illumination angles and dispersion for a homogeneous lighting, and incidence geometry to ensure a high contrast between the background, which may comprise or consist of the vascular model support and / or the dispersion element and the vascular model. This combination allows precise visualization of a variety of available vascular models in at least one visible wavelength range, preferably selectedfrom the list comprising green light, red light, blue light, violet light, yellow light, orange light, a combination thereof, or a continuous spectrum, and / or UV and / or IR wavelength range.

[0062] A “light source”, also referred to as “radiation source” or “illumination source” is in the spirit of the current invention is a device selected from UV diodes, LEDs, IR emitters , or combinations thereof, which emits electromagnetic radiation in specific wavelength ranges, such as UV, VIS, or IR, herein also referred to as UV light source, IR light source and VIS light source.

[0063] In some preferred embodiments, the light source is selected from the list comprising or consisting of UV-Diode, LED, OLED, halogen lamp, xenon arc lamp, mercury vapor lamp, fluorescent lamp, excimer lamp, or a combination thereof.

[0064] A “UV-Diode”, as referred to herein, is understood as a light-emitting diode specifically designed to emit ultraviolet radiation within the UV spectrum, preferably ranging from 100 nm to 400 nm, offering high efficiency and precise wavelength targeting for applications like fluorescence imaging.

[0065] An “LED”, as referred to herein, is understood as a light-emitting diode that produces visible light within the VIS range, typically 400 nm to 700 nm, or ultraviolet radiation, known for its energy efficiency, durability, and adaptability across various wavelengths.

[0066] An “OLED”, as referred to herein, is understood as an organic light-emitting diode capable of emitting light in the UV, VIS, or near-IR spectrum, characterized by its thin, flexible design and ability to produce high-quality, uniform illumination.

[0067] A “halogen lamp”, as referred to herein, is understood as a tungsten filament lamp filled with halogen gas, emitting broad-spectrum light covering both UV and VIS ranges, commonly used for high-intensity and continuous illumination.

[0068] A “xenon arc lamp”, as referred to herein, is understood as a high-intensity light source that generates continuous light across the UV and VIS ranges by creating an electrical arc between xenon gas electrodes, often used in spectroscopy and imaging.

[0069] A “mercury vapor” lamp, as referred to herein, is understood as a gas-discharge lamp that emits strong lines in the UV and visible spectrum, ideal for applications requiring specific UV wavelengths.

[0070] A “fluorescent lamp”, as referred to herein, is understood as a low-pressure gas-discharge lamp that produces light by exciting a phosphor coating with ultraviolet radiation, covering a broad spectrum from UV to VIS.

[0071] An “excimer lamp”, as referred to herein, is understood as a narrow-band ultraviolet light source that utilizes excimer gas molecules to emit radiation at specific UV wavelengths, suitable for precise and high-intensity applications.

[0072] The light source is designed to provide homogeneous illumination and can operate in a continuous or pulsed mode depending on the desired application. Preferably, a light source comprises or consists of an arrangement of multiple individual light sources, preferably emitting in the same wavelengths, either spaced apart or positioned adjacent to one another, to achieve homogeneous illumination. A single spotlight source without a dispersionelement is less preferred, as they tend to create shadows and uneven contrast across the model, thereby compromising the quality and consistency of the illumination.

[0073] In some preferred embodiments of the light source, different arrangements of light sources emitting the same wavelength can be combined to provide switchable and homogeneous illumination of a vascular model. This allows for optimal imaging across various wavelength ranges, such as green, violet, blue, red, or white (continuous) light. In some embodiments, at least two light sources, are arranged in a light source arrangement, which provide a homogenous dispersed background light to archive high contrast. Preferably, the light source arrangement comprises or consists of LED and / or OLED light sources, distanced to each other, preferably by 1 to 10 mm, which may emit light of the same or different wavelengths. Through the dispersion element this creates a homogeneous background illumination.

[0074] In a preferred embodiment, the device comprises at least two optical imaging devices selectively each detecting different wavelength range selected from the list comprising UV-, VIS- and IR-range. This allows for visualization methods, where a secondary parameter, such as an injected UV contrast medium, can be turned on and off on the screen by selecting one or the other wavelength range.

[0075] In some preferred embodiments, the optical imaging device and a UV and / or VIS light source are adapted for high contrast optimization by selecting the best conditions, namely wavelength for the used vascular model, preferably by providing at least two, more preferably at least three light sources emitting in different lightwavelengths, detectable by the optical imaging sensor or sensors, and the computational unit generating a false color image. The inventor has found that some vascular models and medical devices have higher contrast in dedicated wavelengths, for example green or red light, which may differ from model to model. Therefore, this embodiment of the device is designed in such a way that the best wavelength for highest contrast may be chosen by the operator on the spot.

[0076] In some very preferred embodiments, the device in accordance with the current invention comprises or consist of at least one VIS light source, which is a light source which emits at least a defined wavelength range in the visible spectrum as defined herein.

[0077] In some preferred embodiments, at least one additional light source is arranged within the enclosed housing of the device. This additional light source emits at a different wavelength than the primary light source and can be used to enable alternative imaging modes. For example, an ultraviolet (UV) light source may be utilized alongside a VIS light source, expanding the range of imaging capabilities and enhancing versatility for different applications.

[0078] A “dispersion element” in the spirit of the current invention ensures the uniform distribution of light emitted by the light source and is transparent, preferably at least 90% to 99.9%, for this light wavelength. Preferably it covers all light sources. Alternatively, preferably it has the same dimensions, especially area, as the vascular model support. By diffusing the illumination, the dispersion element enhances homogeneity across the illuminated area, reducing shadows and glare that could affect imaging quality. This element allows for maintaining consistent light intensity and ensuring high contrast between the transparent vascular model and the background, which may be the vascular model support and / or the dispersion element itself.

[0079] In some preferred embodiments, the dispersion element is directly placed on a light source, such as an LED, or is part of the light source. In some other preferred embodiments, the dispersion element is directly arranged on or within the vascular model support. In some other preferred embodiments, the dispersion element is a planarelement arranged parallel to the light source attachment plane, such as the enclosing bottom, and the vascular model support.

[0080] In some alternatively preferred embodiments, the dispersion element is designed as planar dispersion element. This may include a layer on the vascular model support, a coating and / or layer on a light source or an array of light sources, such as a planar LED array, or a planar dispersion plate, preferably with a height between 0.1 cm and 2 cm. This allows for an equal background irradiation of the vascular model and a single plane of reference.

[0081] In some very preferred embodiments, light source(s) and dispersion element are arranged to archive a planar, homogeneous light source, i.e. it provides illumination plane over a whole area as a continuous background. This illumination plane preferably covers at least the same area as the model support.

[0082] In some very preferred embodiments, the simulation device may have two or more planes of illumination, which comprise light source(s) and a dispersion element, which are arranged on opposite sides of the model support. In that embodiment, the incidence angle is measured between the optical axis of the optical imaging device and the surface normal to the plane of the dispersion element of the currently illuminated plane of illumination. In this way, the vascular model can be view from above and below the vascular model support by adjusting the incidence angle. The incidence angle in this embodiment is adjustable within a range of 80° to 0°, as determinable from each side of the dispersion element of the currently illuminated plane of illumination.

[0083] In some embodiments, the dispersion element and / or the vascular model support may comprise markings and / or scales to help with orientation of the visualization system and for calibration or assessing distance moved during the procedure. When related to the software program product, the markings and / or scales can be used as reference and calibration point. This allows for characterization and cross compatibility between different vascular models.

[0084] In some preferred embodiments related to IR optical imaging devices, the dispersion element is utilized to enhance thermal contrast with the vascular model. Since IR optical imaging devices detect the thermal radiation emitted by the vascular model, creating a temperature differential between the vascular model and its surroundings is essential for high-contrast imaging. In this context, the dispersion element may be actively cooled through integrated cooling channels or cooling elements to maintain a lower temperature. Alternatively, the dispersion element can passively remain cooler than the vascular model by being exposed to ambient temperature and positioned at a distance from the vascular model support, where the fluid within the vascular model is heated, preferably in a range between 35 and 40°C. This ensures sufficient thermal contrast for accurate and high-quality IR imaging.

[0085] In the spirit of the current invention, the incidence angle, also referred to as view angle, is defined as the angle formed between the optical axis of the optical imaging device and the surface normal to the plane of the dispersion element. The incidence angle is adjustable within a range of 0° to 80° to accommodate specific imaging requirements and ensure high contrast with the model support and / or the dispersion element. By carefully controlling the incidence angle, the system optimizes light reflection and transmission properties, minimizing glare and maximizing contrast between the background, preferably the vascular model support or dispersion element, and the transparent vascular model. This adjustment ensures that the captured images provide high clarity and detail, tailored to the operational wavelength and simulation conditions.An “optical imaging device” refers to a high-precision imaging component, such as a camera or sensor, specifically designed to capture transmitted-light images within the same wavelength range as emitted by the light source, and / or the thermal radiation of the vascular model, and / or a complementary wavelength. Preferably, the optical imaging device can detect radiation in the 10 nm to 1,000 nm range, covering ultraviolet (UV) and visible (VIS) light, and / or in the 8,000 nm to 14,000 nm range, optimized for thermal infrared (IR) radiation. A complementary wavelength may include light emitted by UV-absorbing compounds, which fluoresce and emit visible light. This device is designed to detect variations in light intensity and wavelength, enabling the generation of high-contrast images with exceptional clarity. It may optionally include features such as wavelength filters or false-color generation algorithms to emphasize specific spectral ranges and enhance image visualization. The optical imaging device is capable of producing a digital image or video signal, which can be transmitted to a processing unit for further analysis. The processing unit is equipped with, or connected to, a data storage unit, allowing for the efficient storage and processing of the captured data.

[0086] In an embodiment of the current invention related to visible (VIS) light sources and VIS optical imaging devices, the system is designed to operate effectively in the VIS range between 450 nm and 750 nm, and preferably within at least one wavelength range. Particularly preferred are ranges selected from the list comprising or consisting of or comprising violet light (380-450 nm), blue light (450-495 nm), green light (495-570 nm), yellow light (570-590 nm), and red light (620-750 nm), a combination of these or a continuous spectrum (450 nm to 750 nm). The system may also utilize combinations of these wavelengths or a continuous spectrum to achieve tailored imaging conditions. Wavelength-specific optimization ensures that the background, such as the vascular model support or dispersion element, appears distinct from the transparent vascular model, enhancing visibility and detail.

[0087] Especially preferred are white light, green light, and continuous light, which have been shown to achieve particularly high contrast in both true-color and false-color display modes, providing superior imaging clarity and versatility for various simulation and validation scenarios.

[0088] In an embodiment of the current invention related to infrared (IR) light optical imaging devices, the system is designed to operate effectively in the IR range between 700 nm and 1 mm, with specific subranges optimized for different applications. Preferred wavelengths are Near-Infrared (NIR, 700-1,400 nm), Mid-Infrared (MIR, 1,400-3,000 nm), and Long-Wave Infrared (LWIR, 8,000-14,000 nm). IR imaging is particularly suited for visualizing temperature-dependent properties of the vascular model or surrounding medium, offering unique insights into thermal gradients and flow dynamics. LWIR imaging is preferred for applications such as thermal pattern recognition, flow analysis based on temperature gradients, and the generation of enhanced false-color thermal imaging displays. This capability allows for precise visualization of thermal dynamics and flow behavior within the vascular model, making it particularly effective for simulations and validations that require detailed thermal analysis.

[0089] In an embodiment of the current invention related to ultraviolet (UV) light sources, the system is designed to operate effectively in the UV range between 10 nm and 400 nm, and preferably within specific subranges.

[0090] Particularly preferred are the UVC (100-280 nm), UVB (280-315 nm), and UVA (315-400 nm) light source ranges. UV light is particularly effective for applications involving fluorescence imaging, where UV-absorbing compounds in the vascular model or surrounding medium emit visible light upon excitation. This complementary emission allows for enhanced visualization of structural details within the model.

[0091] In some preferred embodiments, a UVA light source has been shown to provide superior imaging performance in fluorescence-based applications with fluorescent markers injected into the vascular model. For example, blood,and in particular its constituents, have different fluorescent properties that can interact with the material of a medical device, which can be illuminated and visualized using a UVA light source and a compatible light detector, such as a UV / VIS detector. This can be used to verify and / or test that the selected material of a tested medical device is interacting with blood tissue as intended.

[0092] In some preferred embodiments, the medical device further includes a kinematic system to enhance the flexibility and precision of the optical imaging device's positioning. This system provides an attachment point for the optical imaging device and is equipped with locomotion mechanisms to adjust the position of the imaging device relative to the vascular model support. The kinematic system is preferably selected from the list comprising or consisting of servo motors, rotational mechanisms, rail systems, robotic arms, or other comparable systems that facilitate controlled and precise movement. The kinematic system is connected to the processing unit and / or a central processing unit and is controlled by a computer program product in the spirit of the current invention.

[0093] In one embodiment of the simulation device, the imaging device is mounted on a kinematic system, which is adapted to allow movement of the imaging device along at least two axes and to provide one rotational degree of freedom. This configuration ensures sufficient flexibility for a wide range of imaging angles and perspectives.

[0094] In an especially preferred embodiment, the kinematic system is adapted to allow movement of the imaging device along three axes and to provide at least two rotational degrees of freedom, offering enhanced maneuverability and the ability to capture comprehensive imaging data from multiple orientations. This advanced kinematic capability is particularly advantageous for complex simulations, enabling precise tracking and visualization of the vascular model and associated medical devices.

[0095] A “medical device” in the spirit of the current invention refers to any instrument, apparatus, implement, or similar article specifically designed for use in the diagnosis, prevention, monitoring, treatment, or alleviation of medical conditions, particularly in the context of endovascular procedures. The medical device may be used for diagnostic purposes, therapeutic interventions, or both, and it is intended to interact with the vascular system within the simulated environment provided by the invention.

[0096] In some embodiments, the medical device is a catheter, which is a flexible, tubular instrument used to access and navigate blood vessels for a wide range of procedures, such as delivering therapeutic agents, measuring vascular parameters, or facilitating diagnostic imaging.

[0097] In some embodiments, the medical device is a thrombectomy device, specifically designed to remove blood clots (thrombi) from the vascular system. These devices may include mechanical systems such as aspiration catheters, stent retrievers, or rotating thrombus extraction tools, which require precise manipulation within the vascular model to replicate realistic procedural conditions.

[0098] In other embodiments, the medical device may include a broad range of instruments used in endovascular procedures, preferably selected from the list comprising or consisting of guidewires, balloon catheters, endovascular coils, vascular access devices. These medical devices are intended to interact with the vascular model in the simulation system, enabling practitioners to train and validate their use in a controlled, realistic environment.

[0099] Guidewires are thin, flexible wires that facilitate the navigation of catheters through tortuous vascular pathways. Balloon catheters are devices used to dilate narrowed vessels during angioplasty procedures. Stent systems areinstruments used to deliver and deploy vascular stents for treating occlusions or aneurysms. Endovascular coils are small, coiled wires used to treat aneurysms by inducing clot formation within the vessel. Vascular access devices are instruments designed to create or maintain access to the vascular system, such as introducer sheaths or needles.

[0100] Another important feature of the invention relates to the fluid provision to the vascular model. In real conditions, blood circulates and may be blocked or hindered by a plethora of different medical reasons. Therefore, having a fluid delivery system for the vascular model is necessary for many training and validation scenarios.

[0101] In a preferred embodiment, the vascular model support for arranging and fixing a transparent vascular model, comprises at least a fluid access port and at least a device access port for medical devices; wherein the fluid access port the device access port is preferably arranged on the housing and / or the vascular model support, depending on an internal or external fluid pump and fluid reservoirs arrangement. This allows a flexible and efficient fluid provision.

[0102] In some preferred embodiments, the simulation device comprises a fluid pump and fluid reservoirs. This allows provision of fluid to the vascular model via the fluid access ports, which enables realistic conditions with flowing fluids.

[0103] In some other preferred embodiments, the fluid pump is designed as a pulsatile pump to simulate natural blood flow dynamics within the vascular model. This increases the realism of the simulation conditions.

[0104] In a preferred embodiment, the fluid pump and fluid reservoirs are arranged outside of the simulation device in accordance with the invention, which allows for easy access and change or refilling of the fluids during the testing or validation with the enclosed housing in locked and / or closed state. In this case, the at least one fluid access port and at least one device access port are arranged on a surface of the enclosed housing, preferably in the second housing part (underside) and provide access to the vascular model arranged on the vascular model support. Here, advantageously, these access ports are designed in such a way that they block out light, such as a sealing element, untransparent fluid tubes or hose, or untransparent rubber septum. Advantageously, these access openings are designed to block light, for example in the form of a sealing element, light-tight liquid tubing or pipes or light-tight rubber membranes or septa.

[0105] In an alternatively preferred embodiment, the fluid pump and fluid reservoirs may be arranged within the enclosed housing. This increases transportability and reduces possibilities of tempering with the fluids as well as reduces spilling risks. Here, the least one fluid access port and at least one device access port are arranged on the vascular model support.

[0106] In certain embodiments, the device access port is designed to be manually adjustable in its orientation and position relative to the enclosed housing and the vascular model arranged therein. For this purpose, the device access port is arranged in a star-shaped guide element, preferably a regular star-shaped guide element having 3 to 6 radial guide arms, forming a radially symmetric indexing guide. The guide element provides predefined indexing positions, for example at the center, at the ends of the radial guide arms, or at intermediate indexed increments along a guide arm. The device access port can be selectively locked at each of these predefined positions.In a preferred embodiment, the device access port (2.3) is arranged in a star-shaped guide element, in particular as a recess, that provides predefined indexing positions, each of which can be mechanically locked. This allows the access position to be set reproducibly, ensuring consistent spatial orientation between repeated validation attempts.

[0107] In some preferred embodiments, the star-shaped guide element provides a shading device, such as brush combs, sliding covers, or a cover element, to reduce the incidence of light in the set position of the device access port. This enables a low-light environment for high-contrast simulations, especially in embodiments were the enclosed housing preferably blocks 90.0% to 99.9% of external UV / VIS radiation.

[0108] In a further preferred embodiment, the predefined indexing positions of the star-shaped guide element are numerically labeled, allowing the device access port (2.3) to be assigned to a specific documented access setting. This enables standardized and traceable test conditions, improving test documentation and comparability across users or laboratories.

[0109] In another preferred embodiment, the device access port (2.3) is movable along each radial guide arm in defined linear increments with a repeatable step size. This allows controlled variation of the lateral spacing and curvature of the simulated access route, enabling systematic evaluation of catheter performance under different anatomical tortuosity conditions.

[0110] In a further preferred embodiment, repositioning the device access port (2.3) along different guide arms of the star-shaped guide element allows controlled variation of the angle of introduction of the medical device into the vascular model. This allows the influence of access angle on device handling, trackability, and material performance to be quantified and compared under standardized conditions.

[0111] The ability to reposition and lock the device access port in discrete indexing positions enables the controlled variation of the angle of introduction of a medical device into the vascular model. Anatomical access angles differ across patients, and the angle of introduction influences device handling characteristics and performance. By allowing the angle to be varied in a standardized and reproducible manner, the system permits systematic evaluation and comparison of medical devices under defined access geometries. Maintaining a constant angle across repeated validation runs increases test reliability, comparability, and reproducibility.

[0112] Furthermore, anatomical variance not only affects the angle of introduction but also the lateral spacing and tortuosity (curvature) of the anatomical access route. By adjusting the relative positions of two device access ports arranged in the star-shaped guide element, different lateral distances and curvature simulations can be reproduced. This enables the modeling of wider or narrower access paths and anatomical tortuosity, which influence catheter performance, trackability, and material behavior.

[0113] In the spirit of the current invention, fluid reservoirs refer to storage containers designed to supply and collect fluid within the vascular model. These reservoirs are essential for maintaining a controlled and efficient fluid circulation system. In preferred embodiments, the fluid reservoirs comprise at least one tank and, more preferably, two separate tanks: a supply tank for providing fresh fluid to the vascular model and a collection tank for receiving used (spent) fluid after circulation. The dual-tank arrangement ensures a closed-loop system, preventing spillage and maintaining fluid integrity. Depending on the arrangement, the reservoirs may be positioned outside the enclosed housing for easy access and refilling or within the housing to enhance transportability, minimize contamination risks, and reduce tampering possibilities.In the spirit of the current invention, fluid refers to a liquid medium specifically designed to replicate the physical, chemical, and visual properties of biological fluids, preferably blood, for realistic simulation and validation scenarios. Preferably, the fluid is selected from the list comprising or consisting of water, deionized water, saline solution, synthetic blood, simulated blood, color indicator containing fluids. Herein, saline solutions are aqueous solutions comprising salts and other additives and provide a clear, isotonic medium for basic flow simulations; synthetic blood refers to aqueous solutions formulated to mimic the viscosity, density and rheologic properties of human blood; simulated blood is an aqueous solution such as synthetic blood, while also comprising a visually red dyes or pigments to resemble human blood appearance; color indicator-containing fluids, which are infused with pH-sensitive or oxygen-sensitive indicators to simulate physiological changes. Water is the simplest liquid and may be provided as deionized water to reduce salt deposits on pumps and the model.

[0114] A “processing unit”, also referred to as “processor” in the spirit of the current invention is a computational component connected, but not limited to, with the high-contrast visualization system comprising the optical imaging device, responsible for processing the captured image data, the kinematic system, the communication unit, the light sources, optionally fluid pumps and is preferably designed as a processing unit arranged within the device, more preferably within the enclosed housing The unit may incorporate algorithms or machine learning models to further optimize contrast, remove noise, and enhance the visual representation, such as false color visualization or X-ray simulation mode, of the vascular model. False color herein describes the visualization of the vascular model on a screen in a different wavelength then detected by the optical imaging device.

[0115] A “central processing unit” is similar to the processing unit, but is arranged distanced to the device, not within the device, and may have higher computational capacities. It could be arranged within a server or in a remote computer and is used to carry out further refinement of the data produced by the device. This may be recording and editing of training videos, assembling reference settings and optimizing training and validation setting across multiple devices.

[0116] In the spirit of the current invention, a “data storage unit” refers to a component or system designed to securely store data generated by the simulation device, including image streams, experimental logs, training session recordings, validation results, and metadata. The data storage unit may be integrated within the simulation device as an onboard unit or arranged externally as part of a central processing system or cloud-based solution.

[0117] The data storage unit is preferably selected from the list comprising or consisting of solid-state drives (SSD), hard disk drives (HDD), memory cards, or network-attached storage systems, wherein network attached storage systems are preferably accessed via the communication unit. These storage solutions ensure the capability to handle large volumes of high-resolution image and video data provided by the imaging system while providing efficient access and retrieval for analysis.

[0118] In some preferred embodiments, the data storage unit supports secure data management protocols, such as encryption, to protect sensitive information. It is also designed to enable seamless synchronization with a knowledge database, allowing centralized storage and cross-device analysis. This ensures the reproducibility of experiments, the traceability of training or validation procedures, and the optimization of settings across multiple devices.

[0119] In the spirit of the current invention, a communication unit refers to a component or system designed to enable data exchange between the simulation device and external devices, such as a knowledge database, centralprocessing unit, or external screens. The communication unit may support wireless communication, preferably selected from the list comprising or consisting of Wi-Fi, Bluetooth, 4G, 5G, or other mobile communication protocols, and / or wired communication, preferably selected from the list comprising or consisting of LAN, USB, or serial connections. In preferred embodiments, the communication unit is arranged within the enclosed housing of the device and is designed to transmit image streams, experimental data, or training logs efficiently and securely to external systems. The communication unit ensures seamless integration of the simulation device into broader computational and networking environments, facilitating real-time data sharing, centralized monitoring, and remote processing.

[0120] Preferably, the communication unit (5.0) is configured for cable and / or wireless data transfer using protocols such as LAN, USB, Wi-Fi, Bluetooth, or mobile communication such as 3G, 4G, and / or 5G.

[0121] The invention relates to a computer program product for simulating an intervention image, comprising algorithms, machine learning models, or neural networks trained on image data of X-ray fluorescence and intervention images, wherein the computer program is adapted to convert the recorded image data from the optical imaging device of a simulation device according to the current invention when executed on a processing device and calculate a simulated image. This allows the simulation of a realistic training environment for medical practitioners without radiation exposure related to non-simulated X-ray fluorescence methods.

[0122] The invention also relates to a computer program product executed on a processing unit or a central processing unit, designed to compute the data provided by the high-contrast visualization system and optimize image quality based on the specific characteristics of the individual vascular model. This computer program product facilitates the efficient processing of image data, preferably across different wavelengths, and converts it into an image, preferably a live image, which is transmitted to a screen via a communication unit. This functionality enables the practitioner or tester to fully utilize the device's high-contrast visualization system, ensuring real-time, high-quality imaging fortraining or validation purposes.

[0123] The invention also relates a computer program product that enables data exchange between the device and the knowledge database. In the spirit of the current invention, a computer program is executed on a processing unit and / or a central processing unit. This enables the storage of optical imaging data collected from the high-contrast visualization system and preferably further experimental data collected from further sensors in the device, preferably selected from the list comprising or consisting of pressure data, temperature data, metainformation data, such as time, date, duration, experiment ID and operator, or a combination thereof.

[0124] The current invention also relates to a simulation system, comprising or consisting of a simulation device, a computer program product executed on the processing unit and / or a central processing unit, preferably the computing unit, which compute the data provided by the high contrast visualization system and allow optimization of the image quality based on the individual vascular model.

[0125] In some preferred embodiments, a computer program product is executed on a communication device within the enclosed housing, which has at least a processing unit, a communication unit and preferably a data storage unit, wherein the communication device is preferably selected from the list comprising or consisting of smartphone, computer, miniaturized computer or personal computer equipped with a Wi-Fi system and / or mobile communication system, such as 3G, 4G, 5G, and / or Bluetooth and / or LAN and / or USB, especially preferably a smartphone. This allows for a powerful computing unit with integrated communication unit and data storage unitbe utilized, which can directly process the image stream, store it and transmit the image information to an external screen or second communication unit with a central processing unit for further processing.

[0126] A “smartphone” as defined herein is a handheld mobile device that combines advanced computing capability with communication functions, typically equipped with a touchscreen, a high-speed processor, which is a processing unit in the spirit of the current invention, a camera, and wireless connectivity options such as Wi-Fi, Bluetooth, and mobile communication systems (e.g., 3G, 4G, 5G), which are communication units in the spirit of the current invention, as well as SSD and / or memory card storage units.

[0127] A “miniaturized computer” as defined herein is a compact computing device with reduced dimensions and high portability, designed to perform essential computing tasks. Preferred examples include single-board computers like Raspberry Pi or micro-PCs with at least an integrated processing unit, a communication unit, and a data storage unit.

[0128] In some preferred embodiments, the invention also provides a computer program product comprising instructions which cause a computer to enable the exchange of data between the device and a knowledge database, wherein the knowledge database is set up to store a sequence of the training or validation data.

[0129] A “computer” or “calculator” refers to a technical device designed to process data through programmable calculation rules. These devices execute a series of logical and arithmetic operations to handle, analyze, and manipulate data in accordance with predefined algorithms.

[0130] The “retrieval of data” is defined as the process of downloading data, particularly from a knowledge base, to a local or remote device for further use or analysis.

[0131] The “transmission” or “communication” of data refers to the transfer of data from a source to a target, facilitated by communication protocols and methods specifically adapted for this purpose. This includes both wired and wireless communication methods, ensuring secure and efficient data exchange.

[0132] Preferably, the device according to the invention comprises a knowledge database in which, for example, external protocols can be stored. Preferably, several devices according to the invention can access the knowledge database independently of each other. In this respect, the devices / devices are networked via the knowledge database.

[0133] The invention also relates to a computer system which is arranged to have an algorithm, a machine or an artificial intelligence executed thereon, wherein the algorithm, or the machine or the artificial intelligence is arranged to plan or monitor an experiment carried out by means of the device, logging its execution and optimizing it depending on required process flows, wherein the algorithm, or the machine or artificial intelligence is arranged to access the knowledge database in order to retrieve data therefrom or to store data thereon.

[0134] An algorithm is a unique set of instructions for solving a problem or a class of problems. Algorithms consist of a finite number of well-defined individual steps. The algorithm according to the invention is advantageously implemented in a computer program for execution.The invention also provides a data carrier signal which is arranged to transmit data generated by the device to a computer, a cloud, or to a mobile device or to a computer system or to transmit data from a computer a cloud, or a mobile device, or a computer system to the device, in particular to the controller.

[0135] The current invention also relates to a simulation system, comprising a simulation device according to the current invention, a computer program product executed on the processing unit or a central processing unit, which compute the data provided by the high contrast visualization system and allow optimization of the image quality based on the individual vascular model. This simulation system enables the practitioner or tester to fully utilize the device's high-contrast visualization system, ensuring real-time, high-quality imaging fortraining or validation purposes.

[0136] In some further preferred embodiments of the simulation system, an X-ray fluoroscopic simulation can be generated by the high-contrast visualization system using black-and-white photography techniques. This method employs specific filters designed to capture only certain wavelengths of visible or ultraviolet light, effectively mimicking the appearance of an X-ray fluoroscopic image. By leveraging this approach, the system provides a realistic impression of X-ray imaging without requiring actual X-ray radiation. This capability allows the device to operate within the visible spectrum while achieving a high degree of flexibility, enabling its use for both X-ray simulation and standard visible-light applications.

[0137] In some preferred embodiments of the simulation system, the simulation device comprises an IR optical imaging device and thermal contrast dispersion element, wherein a temperature gradient is used to simulate X-ray fluorescence contrast marking to show blocked or clocked vascular vessels. Herein, a colder or warmer liquid is injected into the vascular model via a medical device access port or a fluid access port, which is tracked via the IR optical imaging system. The dispersion element herein is designed as thermal contrast dispersion element, enhancing the contrast between the background and the vascular model in the incidence angles as defined herein.

[0138] In alternatively preferred embodiments of the simulation system, the simulation device comprises a VIS optical imaging device and VIS light source, wherein a coloring agent is used to simulate X-ray fluorescence contrast marking to show blocked or clocked vascular vessels. A coloring agent may be added via a medical device, for example injected, or by a fluid access port.

[0139] Furthermore, the invention relates to a method for validating medical devices with a medical simulation and validation device or a simulation system, comprising the steps of

[0140] - providing a simulation device (1.0) with a vascular model,

[0141] - entering validation mode, preferably locking the device with the locking element (1.5), then providing appropriate simulation fluid and imaging mode, then

[0142] - collecting optical imaging data with the high-contrast visualization system (3.0) and preferably further experimental data and transferring them to a knowledge database via the communication unit (5.0).

[0143] This method allows for an auto secure and more standardized method for certification and validation of medical devices. Preferably, the method collects data in accordance with medical certification prerequisites, such as country specific medical device directives / regulations, harmonized and international standards including relevant guidance documents.“Validating” or “validation”, in the spirit of the current invention, refers to any process of measuring, analyzing, and collecting data regarding the behavior and performance of a medical device within a simulated environment, especially a vascular model inside of the enclosed housing of the device according to the current invention.

[0144] In some embodiments, validation involves the testing and certification of a medical device to ensure compliance with regulatory standards and performance requirements. In other preferred embodiments, it pertains to fault analysis and post-market surveillance, identifying potential issues or failures in devices already on the market to improve safety and effectiveness. Alternatively, in other preferred embodiments, validation includes comparative analysis with predicate devices, facilitating the development of new medical devices by benchmarking against established products in accordance with regulatory pathways such as substantial equivalence assessments.

[0145] In a preferred embodiment, the method for validating medical devices is further comprising the step of simulating blood flow using a pulsatile pump and recording the interaction of the medical device with the vascular model.EXAMPLES

[0146] An example of an embodiment and further advantages of the invention are shown and explained in more detail below in connection with the following figures, purely schematically, without limiting the invention to them.

[0147] Herein shows

[0148] Fig. 1 : Overview of a first embodiment a simulation device.

[0149] Fig. 2: Overview of a second embodiment a simulation device

[0150] Fig. 3: A schematic depiction of a first embodiment of the high contrast visualization system

[0151] Fig. 4: A schematic depiction of a second embodiment of the high contrast visualization system Fig. 5: A schematic depiction of a third embodiment of the high contrast visualization system

[0152] In Fig. 1 an embodiment of the simulation device (1.0) according to the invention is shown, the components involved being shown schematically. In this exemplary embodiment, the simulation device comprises an enclosed housing (1.1) consisting of a first housing part (1.2), referred to as the upper side, and a second housing part (1.3), referred to as the lower side. These housing parts are connected by two hinge-like elements (1.4), which are designed as quick-connect hinges for easy separation. A locking element (1.5) is arranged on the side opposite the hinge-like elements (1.4) to securely close the housing.

[0153] In this embodiment, the power delivery and distribution system (6.0) is located outside the enclosed housing, alongside the fluid pump (8.0) and the fluid reservoirs (8.1). The fluid reservoirs (8.1) include a first fluid reservoir containing fluid that is pumped by the fluid pump (8.0) into the vascular model through a fluid access port (2.3) via a hose. The fluid exits the vascular model through the same access port (2.3) using a second hose and is directed into a second waste reservoir. The housing further comprises a single medical device access port (2.2) for inserting medical devices into the vascular model.

[0154] The device includes an internal communication unit (5.0), which is located within the enclosed housing and connected to the processing unit (4.0). The processing unit (4.0) is further equipped with a data storage unit (4.1) to handle and store data generated by the simulation device.

[0155] This embodiment features a high-contrast visualization system (3.0), which includes a single optical imaging sensor (3.1), here configured as a visible light (VIS) sensor. The sensor is mounted on a kinematic system (3.5) that allows movement along three axes and provides two rotational degrees of freedom, ensuring precise positioning for optimal imaging.

[0156] The system also includes a semi-transparent vascular model support (2.1), designed as a planar element, which is mounted on four support structures. The vascular model support is distanced from a planar dispersion element (3.3), which is arranged below the vascular model support and above 8 light sources (3.2), which are configured to emit visible light within the visible wavelength range.

[0157] Figure 2 illustrates a variation of the simulation device described in Example 1, wherein the power delivery and distribution system (6.0), the fluid pump (8.0), and the fluid reservoirs (8.1) are all located within the enclosed housing (1.1). This configuration enhances portability and minimizes external connections, making the devicemore compact and transportable. This embodiment is particularly suited for scenarios requiring a self-contained, mobile simulation system while maintaining full functionality.

[0158] Figure 3 depicts an embodiment of the high-contrast visualization system (3.0) as used in the preceding examples, with modifications. In this embodiment, the system includes three optical imaging devices (3.1 ), each positioned at specific incidence angles (3.4) to optimize imaging. Two of the optical imaging devices detect radiation in the visible (VIS) and ultraviolet (UV) wavelength ranges, while the third detects radiation in the infrared (IR) wavelength range. Similar to Example 1, the system comprises a semi-transparent vascular model support (2.1), designed as a planar element mounted on four support structures. The vascular model support is distanced from a planar dispersion element (3.3), which is located below the vascular model support and above six light sources (3.2). These light sources are configured to emit visible and ultraviolet light, ensuring a broad spectral range for high-contrast imaging.

[0159] Figure 4 illustrates an alternative embodiment of the high-contrast visualization system (3.0). In this design, the dispersion element (3.3) is integrated as a layer within the vascular model support (2.1), enhancing compactness and structural stability. The vascular model support includes three vascular model fixing means (2.4), allowing secure attachment and alignment of the vascular model. This embodiment utilizes four light sources (3.2) and a single optical imaging sensor (3.1) to achieve high-contrast visualization. The arrangement simplifies the overall design while maintaining effective imaging capabilities.

[0160] Figure 5 shows another alternative embodiment of the high-contrast visualization system (3.0). In this design, the vascular model support (2.1) is fully transparent, and the light source is a light source array composed of multiple LED light sources integrated directly into the dispersion element (3.3). This integration ensures homogeneous illumination and minimizes the need for additional structural components. A single optical imaging device (3.1) is mounted on a three-axis kinematic system (3.5), enabling precise positioning and adjustable viewing angles. This embodiment provides enhanced flexibility and imaging precision while maintaining a streamlined and efficient system design.

[0161] Figure 6 illustrates an embodiment corresponding to the previous examples, in which two device access ports (2.3) provide access to the enclosed housing (1.1) containing the vascular model. In this embodiment, the device access ports (2.3) are manually adjustable and are arranged within a radially symmetric indexing guide, shown here as a regular five-arm star-shaped guide recess. The radially symmetric indexing guide allows the device access ports (2.3) to be positioned at predefined indexing positions, for example at the center, at the ends of the radial guide arms, or at intermediate positions along a guide arm. The relative positioning of the device access ports (2.3) thereby enables simulation of different anatomical access orientations. The availability of defined indexing positions ensures that spatial parameters remain constant between validation attempts or validation runs, thereby increasing precision, consistency, and reproducibility in the evaluation of medical devices.REFERENCE LIST (1.0) Medical simulation and validation device (1.1) Enclosed housing

[0162] (1.2) First housing part

[0163] (1.3) Second housing part

[0164] (1.4) Hinge-like element

[0165] (1.5) Locking element

[0166] (2.0) Vascular model

[0167] (2.1) Vascular model support

[0168] (2.2) Fluid access port

[0169] (2.3) Medical device access port

[0170] (2.4) Fixing unit

[0171] (3.0) High-contrast visualization system

[0172] (3.1) Optical imaging device

[0173] (3.2) Light source

[0174] (3.3) Dispersion element

[0175] (3.4) Incidence angle

[0176] (3.5) Kinematic system

[0177] (4.0) Processing unit

[0178] (4.1) Data storage unit

[0179] (5.0) Communication unit

[0180] (6.0) Power delivery and distribution system

[0181] (7.0) Screen

[0182] (8.0) Fluid pump

[0183] (8.1) Fluid reservoir

Claims

CLAIMS1. Medical simulation and validation device (1.0) for simulating vascular interventions and testing medical devices for such interventions, wherein the device (1.0) comprisesan enclosed housing (1.1), comprising a first housing part (1.2) and a second housing part (1.3), connected by a hinge-like element (1.4) and preferably secured by a locking element (1.5);a vascular model support (2.1) for arranging and fixing a transparent vascular model (2.0), equipped with a fluid access port (2.2) and a device access port (2.3) for medical devices;a high-contrast visualization system (3.0), comprising at least an optical imaging device (3.1) and a light source (3.2), wherein the optical connected to a processing unit (4.0) with a data storage unit (4.1 ); wherein at least one dispersion element (3.3) is placed between the light source (3.2) and the vascular model support (2.1), and wherein the optical imaging device (3.1) is arranged in an incidence angle (3.4) of 0° to 80° to the plane of the dispersion element (3.3);a communication unit (5.0) connected to the processing unit (4.0), for transmitting optical imaging data collected from the high-contrast visualization system (3.0);a power delivery and distribution system (6.0);characterized in thatthe simulation device (1.0) is connected to at least a screen (7.0) via the communication unit (5.0), which screens a high contrast image or simulated intervention image provided by the visualization system (3.0), andwherein at least the vascular model (2.0), the vascular model support (2.1 ), the contrast visualization system (3.0) and dispersion element (3.3) are arranged fully within the housing (1.1),wherein the high contrast live image is selected from the list consisting of X-ray fluorescence simulation live image, colored high-contrast live image, UV-fluorescence live image, real color high-contrast live image.

2. Simulation device (1.0) according to claim 1 , wherein the light source (3.2) is selected from the list consisting of UV-Diode, LED, OLED, halogen lamp, xenon arc lamp, mercury vapor lamp, fluorescent lamp, excimer lamp, or a combination thereof.

3. Simulation device (1.0) according to claims 1 or 2, wherein at least two light sources (3.2) are arranged in a light source arrangement (3.4), which provide a homogenous dispersed background light to archive high contrast.

4. Simulation device (1.0) according to any claims 1 to 3, wherein the device comprises at least two optical imaging devices (3.1) selectively each detecting different wavelength range selected from the list comprising UV-, VIS- and IR-range.

5. Simulation device (1.0) according to any claims 1 to 4, wherein the enclosed housing preferably blocks 90.0% to 99.9% of external UV / VIS radiation, as determined using a photodetector.

6. Simulation device (1.0) according to any claims 1 to 5, wherein the enclosed housing comprises a sealing element arranged between first and second housing (1.2, 1.3).

7. Simulation device (1.0) according to any claims 1 to 6, wherein the optical imaging device (3.1) and a UV and / or VIS light source (3.2) are adapted for high contrast optimization by selecting the best conditions, namely wavelength for the used vascular model, and the computational unit generating a false color image.

8. Simulation device (1.0) according to any claims 1 to 7, wherein the imaging device (3.1) is arranged on a kinematic system (3.5), wherein the kinematic system (3.5) is adapted to allow movement of the imaging device (3.1) in at least two axes and one rotational degree of freedom.

9. Simulation device (1.0) according to claims 8, wherein the kinematic system (3.5) is adapted to allow movement of the imaging device (3.1) in three axes and at least two rotational degrees of freedom.

10. Simulation device (1.0) according to any claims 1 to 9, wherein the device further comprises sensors selected from temperature, pressure, magnetic field sensors.

11. Simulation device (1.0) according to any claims 1 to 10, wherein the medical device is a catheter.

12. Simulation device (1.0) according to any claims 1 to 11, wherein the medical device is a thrombectomy device.

13. Simulation device (1.0) according to any claims 1 to 12, wherein the vascular model is selected from the list comprising or consisting of full human vascular model, cerebral vascular model, peripheral vascular model, major circulatory vascular model, or a combination of these.

14. Simulation device (1.0) according to any claims 1 to 13, wherein the simulation device (1.0) comprises a fluid pump (8.0) and fluid reservoirs (8.1).

15. Simulation device (1.0) according to any claims 1 to 14, wherein the fluid pump (8.0) is designed as a pulsatile pump (8.2) to simulate natural blood flow dynamics within the vascular model (2.0).

16. Simulation device (1.0) according to any claims 1 to 15, wherein the communication unit (5.0) is configured for cable and / or wireless data transfer using protocols such as LAN, USB, Wi-Fi, Bluetooth, or mobile communication such as 3G, 4G, and / or 5G.

17. Simulation device (1.0) according to any claims 1 to 16, wherein the screen is designed as an augmented reality (AR), virtual reality (VR), or extended reality (XR) system.

18. Simulation device (1.0) according to any claims 1 to 17, wherein the housing fully comprises the power delivery and distribution system (6.0).

19. Simulation device (1.0) according to any claims 1 to 18, wherein the vascular model support (2.1) comprises at least a fixing unit (2.4) for securing and positioning a vascular model (2.0).

20. Simulation system, comprising a simulation device (1.0) according to any claims 1 to 19, a computer program product executed on the processing unit (4.0) or a central processing unit (4.2), which compute the data provided by the high contrast visualization system (3.0) and allow optimization of the image quality based on the individual vascular model.

21. Simulation system according to claim 20, wherein the simulation device comprises an IR optical imaging device (3.1) and a thermal contrast dispersion element (3.3), wherein a temperature gradient is used to simulate X-ray fluoroscopy contrast marking to show blocked or clocked vascular vessels.

22. Simulation system according to claim 21 , wherein the simulation device comprises an VIS optical imaging device (3.1) and VIS light source (3.2), wherein a coloring agent is used to simulate X-ray fluoroscopy contrast marking to show blocked or clocked vascular vessels.

23. Method for validating medical devices with a medical simulation and validation device (1.0) according to any claims 1 to 19 or a simulation system according to claims 20 to 22; comprising the steps ofproviding a simulation device (1.0) with a vascular model,entering validation mode, preferably locking the device with the locking element (1.5), then providing appropriate simulation fluid and imaging mode, thencollecting optical imaging data with the high-contrast visualization system (3.0) and preferably further experimental data and transferring them to a knowledge database via the communication unit (5.0).

24. Method for validating medical devices according to claim 23, further comprising the step of:simulating blood flow using a pulsatile pump according to claim 13 and recording the interaction of the medical device with the vascular model.

25. Computer program product for simulating an intervention image, comprising algorithms, machine learning models, or neural networks trained on image data of X-ray fluoroscopy and intervention images, wherein the computer program is adapted to convert the recorded image data from the optical imaging device (3.2) of a simulation device according to claims 1 to 19 when executed on a processing device and calculate a simulated image.

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