Embolic substance simulator having the anatomy of the middle meningeal artery

Abstract

The invention relates to a system based on the anatomy of the middle meningeal artery, for simulating embolisation with embolic substances. The configuration of the system allows for quick assembly and disassembly, facilitating its use in training workshops. This improves the quality of medical training and promotes the use of this non-invasive treatment for chronic subdural haematomas. The invention comprises a base that acts as a support and stabiliser, and a branched model which, with internal diameters of up to 0.5 mm, replicates the actual internal anatomical tortuosity of the middle meningeal artery.

Description

[0001] DESCRIPTION

[0002] Embolizing substance simulator with the anatomy of the middle meningeal artery

[0003] TECHNICAL SECTOR

[0004] The present invention relates to a neurovascular system that allows for the simulation, in a realistic environment, of embolization of the middle meningeal artery using various commercially available embolic agents, such as polyvinyl alcohol (PVA) particles and cyanoacrylates. The system is based on an anatomical model that faithfully reproduces the anatomy of the middle meningeal artery. The objective of the invention is to achieve a high correlation between the test bench and the actual procedure, allowing the medical team to experiment with and test both the approach and the use of the different embolic agents.

[0005] Similarly, the invention facilitates the evaluation of the behavior of new embolizing substances under development within a quasi-real environment.

[0006] BACKGROUND OF THE INVENTION

[0007] Embolization with embolic agents falls under the category of minimally invasive surgical procedures. In the field of interventional neuroradiology, this approach is increasingly used in the middle meningeal artery as a non-invasive alternative for treating chronic subdural hematomas. Despite the growing number of centers and specialists adopting this treatment, most still opt for burr holes, given the complexity and cost of acquiring the skills and technical training required to embolize the middle meningeal artery. The use of animal models is declining, while available simulators primarily focus on peripheral areas of the human body, such as the kidneys and arteries of the digestive tract.

[0008] Currently, three-dimensional models and additive manufacturing are being used in a large number of sectors as production technologies for short series because they offer great flexibility and the possibility of customization.

[0009] Among the known models of embolizing substance simulators are those disclosed in patent documents US20220137593, JP2015069054A, US20060099557, US2019244544A1, CN106463067A.

[0010] These are simplified models focused on aneurysms, virtual simulators, and idealized and simplified peripheral system anatomies, resulting in an unreliable correlation with real practice.

[0011] Furthermore, because these models are not based on the specific anatomy of the middle meningeal artery, they do not allow for effective training for healthcare professionals. The decreasing diameters and the complex, tortuous anatomy of this artery cause embolic agents to behave very differently than they would in a real-life procedure.

[0012] Thanks to the growing expansion of additive manufacturing (or three-dimensional printing, commonly known as 3D printing), especially stereolithography (SLA), as a productive alternative in traditional industry and its rapid implementation in manufacturing sectors, solutions are being offered to industrial, healthcare, and even quality-of-life technical problems. SLA technology is used for modeling prototypes and short production runs, enabling the manufacture of dimensionally stable parts with complex and intricate geometries that are strong, durable, and offer good precision and reproducibility.

[0013] This combination has made manufacturing viable where the number of units to be produced does not pose a barrier to offering a necessary product. However, to date, using the standard parameters and operations recommended by the suppliers of the machines for this technology, the use of the SLA technique for manufacturing conduits with a diameter or internal lumen of less than 3 mm is not feasible, since the traditional manufacturing parameters do not allow for the removal of uncured liquid resin residue from inside the arteries or conduits, and therefore do not allow for medical practice, invalidating the simulation system.

[0014] For all the above reasons, the applicant of this patent application identifies the need to develop a simulator of embolic substances that offers a simple but efficient solution to simulate the anatomy of the middle meningeal artery, generating haptic sensations of real practice, thus enabling the training of healthcare professionals in this treatment. DESCRIPTION OF THE INVENTION

[0015] The present invention allows for the reliable and realistic reproduction of the anatomy of the middle meningeal artery. This facilitates more detailed training and preparation for embolizations of this artery, enabling the medical team to make more precise decisions regarding the appropriate embolizing agent and the best possible approach.

[0016] To achieve this, the invention proposes a simulator of embolic substances based on the anatomy of the middle meningeal artery, composed of a branched model on which the clinical simulation is performed and a base that acts as a support and stabilizer.

[0017] In this regard, the base of the simulator of the invention consists of a laminar body, preferably made of rigid material, into which the branched model is attached by pressure. Additionally, the simulator includes a simple plug that is used in the round openings along the branched model, ensuring the simulator is watertight.

[0018] The branched model faithfully replicates the geometry of the middle meningeal artery, with decreasing internal lumens from 2 mm to 0.5 mm, mimicking the actual anatomical internal tortuosity. As the internal lumens decrease in size, round openings are found, facilitating both post-processing and allowing the clinician to select the sections of the artery where embolization is to be performed. At the end of each segment or channel of the branched model (i.e., at its ends), there is a non-return connector that allows for a hermetic and leak-proof connection with the instruments used in the healthcare setting.

[0019] The branched model and the plugs (which fit into the round openings) are made of a transparent material, allowing healthcare personnel to directly observe the behavior of the embolizing substance. Furthermore, the material is radiolucent, enabling its visualization using radiology equipment within the hospital setting.

[0020] It should be noted that the non-return connectors are located outside the base, while the plugs fit into the round openings of the branched model.

[0021] Optionally, the simulator may consist of an internal coating that allows the embolic substances to embolize in the same way as they would upon contact with blood, thus increasing the realism of the simulator.

[0022] The configuration of the present invention is simple and intuitive, allowing the physician to assemble it quickly, facilitating its use in training workshops and improving the quality of medical training.

[0023] BRIEF DESCRIPTION OF THE DRAWINGS

[0024] To complement the description that follows and to facilitate a better understanding of the characteristics of the invention, according to a preferred embodiment thereof, a set of drawings is included as an integral part of said description, in which, for illustrative and non-limiting purposes, the following has been represented:

[0025] Figure 1 shows an exploded view of the elements that make up the embolizing substance simulator based on the anatomy of the middle meningeal artery according to a preferred embodiment of the object of the present invention.

[0026] Figure 2 shows a perspective representation of the simulator assembled according to the preferred embodiment shown in the previous figure.

[0027] Figure 3 shows a top view of the simulator depicted in Figure 2.

[0028] Figure 4 shows a side view of the simulator depicted in Figure 2.

[0029] Figure 5 shows a detailed view of the joint between the plug and the branched model represented in the previous figures.

[0030] PREFERRED EMBODIMENT OF THE INVENTION

[0031] In view of the figures shown 1, 2, 3, 4 and 5, the embolizing substance simulator based on the anatomy of the middle meningeal artery is composed of the following elements according to the preferred embodiment of the invention:

[0032] A base (1) formed by a rigid laminar body that attaches to the branched model (2), providing support and stabilization to the entire simulator.

[0033] - A branched model (2) that replicates the internal tortuosity of the middle meningeal artery, with internal lumens up to 0.5 mm. Additionally, the branched model (2) features round openings (2') that facilitate internal post-processing of the segments or channels. At the end of each segment or channel is a non-return connector (2") that ensures a hermetic and watertight connection with medical instruments. The branched model (2) is integrated with transparent and radiolucent material.

[0034] - At least one plug (3) made of the same material as the branched model (2), i.e. a transparent and radiolucent material, which fits tightly into the round openings (2') of the branched model (2).

[0035] The base (1) provides support and stability to the branched model (2), attaching to it by pressure. On the other hand, the plugs (3) are fitted into the round openings (2') using ethyl cyanoacrylate and pressure, and preferably, the plugs (3) are made of the same material as the branched model (2) into which they are inserted.

[0036] On the other hand, the non-return connectors (2”) are located outside the base (1), facilitating the connection with the medical instruments, as can be seen in figure 2. In this sense, the branched model (2) is provided with a non-return connector (2”) at the end of each channel.

[0037] Advantageously, the branched model (2) features round openings (2'), allowing healthcare personnel to perform different approaches with embolizing agents in different sections of the same model. Preferably, the branched model (2) is made of a rigid, translucent, and radiolucent material.

[0038] Preferably, the branched model (2) is provided with an internal coating that allows the embolic substances to behave in the same way as they would upon contact with blood. Furthermore, the internal lumen of the sections of the branched model (2) gradually decreases from 2 mm to 0.5 mm, with a preferred internal diameter between 0.5 and 1.5 mm, and they have a length of between 20 and 30 cm.

[0039] As described above, the device is designed to be manufactured using additive manufacturing, with the ability to be customized and produced in an industrial environment, according to the project requirements.

Claims

CLAIMS 1 a - Embolizing substance simulator with the anatomy of the middle meningeal artery, characterized in that it comprises: - a base (1) formed by a rigid laminar body, - a branched model (2), made up of a transparent and radiolucent material, being provided with round openings (2') along the branched model (2) and with non-return connectors (2") at its ends, where each section of the branched model (2) has decreasing interior lights from 2 mm to 0.5 mm. - at least one plug (3) made of a transparent and radiolucent material, where The branched model (2) is pressure-fitted to the base (1), leaving the non-return connectors (2”) outside the base (1), while the plug (3) is fitted to the round openings (2') of the branched model (2). 2 a- Embolizing substance simulator with the anatomy of the middle meningeal artery, according to claim 1 a , characterized in that the branched model (2) is made of a rigid, translucent and radiolucent material. 3 a - Embolizing substance simulator with the anatomy of the middle meningeal artery, according to claim 1 a , characterized in that the plug (3) is made of the same material as the branched model (2) on which it is inserted. 4 a - Embolizing substance simulator with the anatomy of the middle meningeal artery, according to claim 1 a , characterized in that the branched model (2) has a length of between 20 and 30 cm. 5 a - Embolizing substance simulator with the anatomy of the middle meningeal artery, according to claim 1 a , characterized in that the branched model (2) has a preferred inner diameter between 0.5 and 1.5mm. 6 a - Embolizing substance simulator with the anatomy of the middle meningeal artery, according to claim 1 a , characterized in that the branched model (2) is provided with an anti-return connector (2”) at the end of each channel of the branched model (2).

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