MEDICAL TRAINING MODEL WITH AT LEAST ONE BLOOD VESSEL MODEL

Description

[0001] The invention relates to a medical training model according to the preamble of claim 1.

[0002] A medical training model offers a wide range of potential applications and can be used, among other things, for the training and continuing education of physicians in minimally invasive catheter treatment of vascular diseases such as aneurysms (bulging of the vessel wall). This replaces animal experiments used for treatment simulation and training, and by replicating relevant vessels, it enables a realistic representation of human anatomy. Such a training model is described in Spallek, J.; Kuhl, J.; Wortmann, N.; Buhk, J.-H.; Frölich, AM; Nawka, MT; Kyselyova, A.; Fiehler, J.; Krause, D.: Design for Mass Adaptation of the Neurointerventional Training Model HANNES with Patient-Specific Aneurysm Models. In: Proceedings of the 22nd International Conference on Engineering Design (ICED19), Delft, The Netherlands, August 5-8, 2019, 897 - 906.

[0003] In training models, the observation of medical instruments is usually carried out by using customizable blood vessel models in an angiography system with X-rays.

[0004] From DE 10 2014 210 893 A1, imaging devices for medical applications are known, for example, X-ray devices with a C-arm on which an X-ray source and an X-ray detector are arranged opposite each other. An operating device, such as a touchscreen, is provided to the operator for control purposes. Such imaging devices are used in the cardiac and vascular fields. X-ray devices with a C-arm are used in particular for imaging in vascular surgery (angiography). In this context, a key objective is to visualize specific vessels or at least a portion of the vascular tree after the injection of a contrast agent.

[0005] A well-known procedure in this context is digital subtraction angiography (DSA). In this procedure, a standard X-ray image of the relevant target area is first taken, the so-called mask image. After the administration of a contrast agent into the vascular system, it spreads throughout the system, and further images are generated, particularly over a period of time, in which the contrast agent is clearly visible. These images are usually referred to as filling images. To visualize the vessels without other interfering structures, the mask image (often also called the blank image) is subtracted from the filling images.

[0006] A disadvantage is that, using the usual training models for training and learning the necessary treatment skills, especially for the treatment of blood vessel diseases, it is not possible to avoid harmful X-rays, as observation of the instruments would otherwise be impossible.

[0007] Alternatively, X-ray-free virtual reality simulations are used, in which trainees are given haptic feedback similar to treatment on a human. However, the realization is only partially comparable to real treatment. Furthermore, only certain training scenarios can be configured. The medical instruments differ from those used in reality. Images and the position of the instruments are simulated, with the image generation relying on feedback from sensors.

[0008] A method is known from US 5,638,819 A by which a medical instrument, in particular a biopsy needle or an endoscope, can be inserted along a desired trajectory into a patient, especially into the patient's brain. To locate the instrument, a sensor is attached to the part of the instrument not inserted into the patient, the position of which with respect to a reference coordinate system can be determined with a suitable measuring device. For navigation of the instrument, its position is superimposed on a two-dimensional tomography image, while a live video image of the endoscope is simultaneously displayed.This well-known method, however, is only suitable for localizing and navigating rigid medical instruments, since only in this case can the position of the part of the instrument inside the patient be inferred from the position of the sensor attached to the part of the instrument located outside the patient. Transferring such a system to a training model is disadvantageous because the treatment skills to be learned for vascular diseases are different.

[0009] From DE 100 51 244 A1, a x-ray-free intravascular localization and imaging method is known in which the image acquisition devices are arranged in the end region of the medical instrument to be inserted. Image information of the area surrounding the medical instrument is acquired, and the position of the medical instrument is displayed in an overview image of the object under investigation based on the determined position. The image data sets themselves can be acquired using any imaging method, such as magnetic resonance imaging (MRI), computed tomography (CT), an x-ray procedure, in particular a three-dimensional rotational x-ray procedure, or an ultrasound procedure. A disadvantage here, too, is that a training scenario does not allow the use of real instruments and realistic probing and treatment of cerebral aneurysms.

[0010] From DE 10 2015 011 062 A1, a device for the visual flow analysis of transparent vessel models is known. These models are physiologically perfused with a glycerol solution of blood-like viscosity and enriched with reflective polymer particles on the order of erythrocytes. A light field camera is used to record the reflections of moving polymer spheres. The flow information at the vessel and its changes due to the insertion of devices for the treatment of aneurysms are used to verify and optimize the quality of necessary interventions by improving the positioning, selection, design, or shape of implanted devices such as coils, stents, or flow diverters. However, such flow information does not provide the physician with a training model for simulating catheter treatments.

[0011] From DE 10 2016 108 152 A1, a three-dimensional vascular surgery simulation model is also known, in which flow patterns of a model are acquired in a recording chamber. The model is located in a circulating fluid, specifically a glycerin-water mixture. Thus, an open flow system is described in which no actual surgical instrument is used; instead, flow conditions are measured to provide insights into the vascular model. Again, it lacks the capability to be used as a training model for simulating medical skills. For this, the tracking of a real instrument and its contrast with the vessel are necessary. This cannot be determined from flow patterns alone.

[0012] The object of the invention is therefore to create a training model with which a training situation related to the vascular territories of the arterial blood supply, for example of the brain, can be easily created, closely approximating the corresponding real-world procedural situations. At the same time, this advantage should be achieved through a device that is simple and inexpensive to manufacture.

[0013] This problem is solved by the features of claim 1.

[0014] This creates a medical training model for simulating minimally invasive catheter treatments, such as for intracranial aneurysms, that operates without X-rays or without the absolute necessity of X-ray radiation. The X-rays can be replaced by radiation simulation using an optical system. This X-ray-free system enables safe, long-term training without exposing trainees to harmful radiation. Familiar procedures and visualizations from angiography can be maintained and learned. This is particularly relevant for simulating neurointerventional treatments for the training and continuing education of physicians. Real instruments are used. Realistic probing and treatment of cerebral aneurysms is possible, with physiological properties such as temperature, blood flow, and pulsation being replicated.

[0015] The solid-state block according to the invention can influence the imaging properties via its outer geometry and, as an isolated inner geometry, incorporate blood vessel anatomies, optionally patient-specific anatomies. The solid-state block thus preferably combines two different functional units at different locations with a selectable spatial separation. For imaging with, for example, a camera, the outer geometry is preferably provided with an optical surface that reduces reflection in order to increase the transmission of the block aneurysm medium.

[0016] The visualization of blood vessels using imaging techniques to simulate medical procedures can be performed with and / or without the use of X-rays. This applies particularly to the creation of digital subtraction imaging and roadmaps, where image datasets that would otherwise be acquired using X-ray imaging are not required and can even be omitted entirely. The advantage of making interfering image aspects invisible through subtraction can be utilized.

[0017] An X-ray-free environment reduces or eliminates the radiation exposure of trainees during exercise. This makes it possible to increase the duration and frequency of training sessions. Training is also possible for individuals who are at high risk from X-rays, such as pregnant women.

[0018] Preferably, the optical system comprises at least one camera and preferably at least one light source, which can be integrated into a head model. Such a head model can offer the possibility of rotating the camera and light source system around an aneurysm model in, for example, degree increments, in order to set different observation / projection planes and slices onto an aneurysm, as preferably with a C-arm of an X-ray system. Preferably, a backlight panel can be used as the light source. The head model can be designed as a mounting device with translational and / or rotational degrees of freedom, whereby the spatial distance between the camera and the light source can also be selected and adjusted. Therefore, a direct connection between the camera and the light source is not required.

[0019] Furthermore, simple integration with rapid exchange of patient-specific vessel geometries, combined with the simulation of a circulatory system, is possible. Realistic training scenarios for neurointerventional treatments are made possible according to the invention, without radiation exposure. The training model is also mobile, allowing for use outside of an angiography suite. This enables an increase in the number of training participants. A training model can be provided in an X-ray-free environment, replicating the vascular space relevant for minimally invasive vascular treatment with the option of exchanging individual geometries, potentially including patient-specific ones, and offering a circulatory simulation system. The invention enables X-ray-free use in angiography.

[0020] The structure of the medical training model can be modular and can consist of standardized components (used in every training scenario), variant components (components that shape the training scenario) and patient-specific components (adapted according to an original patient-specific anatomy).

[0021] The advantageous use of real instruments, realistic probing and treatment of cerebral aneurysms, can also be combined with the simulation of physiological properties such as temperature, blood flow, and pulsation. The high degree of geometric freedom offered by additive or generative manufacturing processes enables the production of vascular models that are an exact three-dimensional replica of patient-specific intracranial aneurysms with their adjacent vascular interiors.

[0022] Further embodiments and advantages of the invention can be found in the following description and the dependent claims.

[0023] The invention is explained in more detail below with reference to the exemplary embodiments shown in the accompanying figures. Fig. 1 shows a schematic representation of a first embodiment of the medical training model, Fig. 2 shows a schematic representation of a second embodiment of the medical training model,

[0024] How Fig. 1 As shown, the invention relates to a medical training model with at least one blood vessel model 1 which can be connected to an anatomically replicated circulatory support system 2 in at least one training region. The training model further comprises an image acquisition device 3 for creating measurement images of the at least one blood vessel model 1. The training model also includes an image processing device 11 which converts the acquired measurement images into an imaging representation of the blood vessels and makes them displayable on a screen 12.

[0025] For preferably X-ray-free imaging, the image acquisition device 3 is designed as a photo-optical system 8 that acquires transmitted light images 13 as measurement images of the at least one blood vessel model 1. For this purpose, the at least one blood vessel model 1 is arranged in a transparent solid block 4. The blood vessel model 1 is preferably designed as a cavity 10 in the solid block 4. Alternatively or additionally, the cavity 10 can be at least temporarily filled with an imaging medium.

[0026] The transparent solid block 4 preferably has smooth, low-reflection surfaces that sandwich-like define the spatial curve of the blood vessel model 1. Consequently, the outer geometry of the solid block 4 is preferably provided with an optical surface that reduces reflection and increases the transmission of the medium of an artificial transparent block aneurysm. The solid block 4 is preferably cuboid in shape with an outer geometry that can be selected depending on the imaging properties. The inner geometry of the solid block 4 is determined by the representation of an aneurysm, which may optionally be patient-specific.

[0027] According to a first embodiment, the image acquisition device 3 is designed as a photo-optical system 8, which preferably comprises at least one camera 5 and at least one light source 6. The at least one light source 6 serves to illuminate the solid block 4. The direction(s) of illumination is / are selectable. Sidelight, incident light, backlight, etc., can be used individually or in combination. Fig. 1 For example, four light sources 6 are provided, illuminating the solid block 4 from different directions. It is essential for the illumination that the interior of the solid block 4, the blood vessel model 1, is visible and imageable. The camera 5 and the light source 6 serve to create a real image of the solid block 4 and the vessel model 1.

[0028] Preferably, the camera 5 and the light source 6 of the photo-optical system 8 can be integrated into a mounting device 7 with translational and / or rotational degrees of freedom and can optionally be positioned relative to each other.

[0029] The mounting device 7 can be designed as a full-arc or C-arc-shaped head model of selectable geometry for setting different observation projection planes and / or views of the at least one blood vessel model 1 and can be moved horizontally, vertically, and about pivot axes for this purpose. A C-arc-shaped head model is preferably provided for setting different observation projection planes and / or views of the at least one blood vessel model 1. The mounting device 7 can be moved horizontally, vertically, and about pivot axes for this purpose, as symbolically illustrated by arrow 18.

[0030] The image processing device 11 is preferably program-controlled for digital subtraction imaging. Color fluids can be injected into the at least one blood vessel model 1 to create blank and filled images.

[0031] The at least one blood vessel model 1 is preferably an additively manufactured, optionally customizable blood vessel model 1, which can be interchangeably connected in at least one training region to a fluid system of an anatomically replicated training model with a lumen of the blood circulation replacement system 2 that may be replicated in a patient-specific manner.

[0032] The at least one blood vessel model 1, which can be replicated with patient-specific geometry, can be connected to the blood circulation replacement system 2 via a hydraulic quick coupling.

[0033] The solid block 4 is made from a lost-wax casting compound of an inversely replicated blood vessel model 1 or by an additive manufacturing process. Multiple training regions with blood vessel anatomical geometry can be implemented via interfaces, allowing the circulatory system 2 to be configured to simulate the human circulatory system with respect to fluid temperature and pressure. The fluid tank 14 and fluid pump 15 can be used in accordance with known open or closed hydraulic circuits. Fig. 1 Figure 16 further symbolically depicts a physician 16 using a real instrument 17 in the blood vessel model 1. For this purpose, the instrument 17 is inserted into the circulatory simulation system 2, which has an access point, such as a sheath. During training, the treatment instrument 17 is preferably guided through simulated arteries to the diseased vessel. The fluoroscopy makes the movements of the instrument 17 within the vessel model visible and enables the physician 16 to move the instrument 17 in a targeted manner.

[0034] The blood vessel model 1 is manufactured transparently. This transparent design allows for a high contrast between the transparent model 1 and the non-transparent treatment instrument 17, such as a microcatheter, guidewire, or coil. The model 1 is manufactured from transparent, particularly non-flexible, material within a transparent plastic block or solid block 4.

[0035] The mounting device 7, or the head model, can be attached to the head end of a base frame of the training model 1. A connection can be made via a skull base model, which can be integrated into the head model, and a neurocurrent pathway 9. The skull base model can replicate the skull base with integrated vascular pathways and an integrated support.

[0036] The head model 7 and the skull base model allow the positioning of one or more vessel models 1, in particular so-called aneurysm models. The vessel models 1 can have one or more aneurysms.

[0037] The preferably modular design of the training model allows for the combination of modules, including standardized or variant modules with interchangeable, individualized modules. A key focus is the integration of patient-specific and individualized geometries. Patient-specific aneurysm models, for example, can be additively manufactured—that is, layer-by-layer or 3D-printed—based on medical image data from patients in a standardized individualization process. A portfolio of diverse aneurysm geometries can be provided as a training basis.

[0038] The invention has been described above using a neurointerventional training model as an example. The invention can also be implemented in any medical training model where patient-specific or standardized blood vessel models are to be placed in interchangeable training regions for training methods. The same applies to training models used as treatment / simulation models for, for example, scientific purposes, research purposes, instrument development, etc.

[0039] How Fig. 2 As shown, the image acquisition device 3 is designed according to the invention as a photo-optical system 8 comprising at least one camera 5 and at least one backlight panel 6, between which the transparent solid block 4 can be positioned. Otherwise, the preceding descriptions of the first embodiment apply accordingly.

Claims

1. Medical training model having at least one blood vessel model (1), that in at least one practice region can be connected to an anatomically replicated substitute blood circulation system (2) and in which a real instrument (17) is used, further having an image recording device (3) for creating measurement images of the at least one blood vessel model (1), and having an image processing device (11) which converts the recorded measurement images into an imaging representation of the blood vessel and displays them on a screen (12), the image recording device (3) is designed as a photo-optical system (8), that records transmitted-light images (13) as measurement images of the at least one blood vessel model (1) for the simulation of medical activity, characterized in that, the at least one blood vessel model (1) is replicated in a transparently produced solid-body block (4) to create a contrast between the transparent solid-body block (4) and the non-transparent instrument (17), the transmitted light images (13) are recordable as measurement images of the at least one blood vessel model (1) against a backlight, and the solid-body block (4) is made from a casting compound having a lost mould of an inversely replicated blood vessel model (1) or by an additive manufacturing process, and said photo-optical system (8) comprises at least one camera (5) and at least one light source (6) with at least one backlight panel (6), between which the transparent solid-body block (4) can be positioned, which serve to determine a real image of said solid-body block (4) and said vessel model (1), and the transparent solid-body block (4) has smooth and reflection-reduced surfaces that sandwich a space curve of the blood vessel model (1).

2. Medical training model according to claim 1, characterized in that the photo-optical system (8) comprises at least one camera (5) and at least one light source (6), which can be integrated into an installation device (7) with translatory and / or rotatory degrees of freedom of movement and can be positioned relative to one another in the process.

3. Medical training model according to claim 2, characterized in that the installation device (7) is designed as a full-arch or C-arch head model of selectable geometry for setting different observation projection planes and / or views of the at least one blood vessel model (1) and which can be moved horizontally, vertically and about pivot axes for this purpose.

4. Medical training model according to any one of claims 1 to 3, characterized in that the image processing device (11) is program-controlled for digital subtraction imaging.

5. Medical training model according to claim 4, characterized in that color fluids are injectable into the at least one blood vessel model (1) for creating blank images and filling images of the at least one blood vessel model (1).

6. Medical training model according to any one of claims 1 to 5, characterized in that the at least one blood vessel model (1) is an individualizd blood vessel model (1) that is interchangeably connectable in at least one practice region to a fluid system of an anatomically replicated training model having a respective patient-specific replicated lumen (9).

7. Medical training model according to claim 6, characterized in that the at least one blood vessel model (1) is a blood vessel model (1) simulated with patient-specific geometry, which can be connected to the blood circulation system (2) via a hydraulic quick coupling.

8. Medical training model according to any one of claims 1 to 7, characterized in that a plurality of practice regions with blood vessel anatomical geometry can be implemented via cuts.

9. Medical training model according to any one of claims 1 to 8, characterized in that the replicated substitute circulatory system (2) is designed to simulate the human blood circulation system in terms of temperature and pressure of the fluid.