An in-vitro blood vessel model comprising a stenosis
Patent Information
- Application Number
- CN202522244418.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-10-23
- Publication Date
- 2026-10-09
- Estimated Expiration
- 2035-10-23
AI Technical Summary
[0004]为了解决目前存在的现有的血管模型无法准确地模拟和调节狭窄斑块的硬度或径向支撑力，导致测量结果与临床实际情况存在偏差的问题，本实用新型提供了一种包含狭窄部位的体外血管模型，所述技术方案如下：
通过设于血管本体外部的狭窄模拟单元的设置，由于内活动套筒为分体式结构设置、且其通过弹性元件与外固定套筒连接，则经与血管狭窄部位紧贴的内活动套筒及弹性元件的设置，可模拟血管本体中的钙化斑块，内活动套筒的径向移动能够为介入器械的扩张提供了更真实、定量可调的径向约束力，从而能够有效模拟从软斑块到重度钙化硬斑块的不同病变，适用性更高，使得介入器械对于该种病变能够具备更准确的模拟结果。
Smart Images
Figure CN224841125U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to an external blood vessel model including a narrowed area, belonging to the field of medical simulation and medical device testing technology. Background Technology
[0002] Interventional therapy is an important means of treating cardiovascular, cerebrovascular, and peripheral vascular diseases. During the research and development and pre-market validation of novel interventional medical devices, thorough in vitro performance testing is essential to evaluate their permeability, delivery capability, compliance, and dilation effect. Existing in vitro testing vascular models mostly use straight tubes made of silicone or 3D-printed vascular models based on medical image reconstruction.
[0003] While these vascular models can effectively reproduce the geometry and tortuosity of blood vessels, they also have significant limitations. They struggle to realistically simulate vascular stenosis, particularly the mechanical properties of calcified plaques. In the human body, calcified plaques exhibit high rigidity, significantly resisting balloon dilation and stent apposition. Therefore, the pathological manifestation of calcified plaques is a key indicator for evaluating device effectiveness. Current vascular models can simulate the "shape" of stenosis, but they cannot accurately simulate and adjust the "rigidity" or "radial support force" of the stenotic plaque. This leads to discrepancies between test results and clinical realities, making it difficult to accurately predict the performance of interventional devices in complex calcified lesions. Utility Model Content
[0004] To address the problem that existing vascular models cannot accurately simulate and adjust the stiffness or radial support force of stenotic plaques, leading to discrepancies between measurement results and clinical realities, this invention provides an in vitro vascular model including the stenotic region. The technical solution is as follows: An ex vivo vascular model including a narrowed region, characterized in that it comprises: The blood vessel body is made of a flexible material and can be pre-formed with narrow sections; The stenosis simulation unit is sleeved on the outside of the blood vessel body and is set corresponding to the stenosis portion thereon. It includes an inner movable sleeve, an elastic element and an outer fixed sleeve in sequence from the inside to the outside. The inner movable sleeve has a split structure and is set close to the outer wall of the blood vessel body. The inner movable sleeve is connected to the outer fixed sleeve through the elastic element.
[0005] Furthermore, the inner movable sleeve is a split structure with lobes, which consists of multiple lobes distributed circumferentially.
[0006] Furthermore, the elastic element is a helical spring, a butterfly spring, or an elastic rubber column, and the flaps of each inner movable sleeve are connected to the outer fixed sleeve through two sets of elastic elements.
[0007] Furthermore, the narrow portion of the blood vessel body is located in its central position, and the blood vessel body is made of silicone or thermoplastic polyurethane material.
[0008] The beneficial effects of this utility model are: By incorporating a stenosis simulation unit located outside the blood vessel body, and considering that the inner movable sleeve is a separate structure connected to the outer fixed sleeve via an elastic element, the calcified plaque in the blood vessel body can be simulated through the inner movable sleeve and elastic element that are in close contact with the stenotic area. The radial movement of the inner movable sleeve provides a more realistic and quantitatively adjustable radial constraint force for the expansion of the interventional device, thereby effectively simulating different lesions from soft plaques to severely calcified hard plaques, making it more applicable and enabling the interventional device to provide more accurate simulation results for such lesions. Attached Figure Description
[0009] To more clearly illustrate the technical solutions in the embodiments of this utility model, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0010] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the present utility model; Figure 2 This is a schematic diagram of the structure of the blood vessel body according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the narrow simulation unit according to an embodiment of the present invention; Figure 4 This is an embodiment of the present utility model. Figure 3 Cross-sectional view; Explanation of reference numerals in the attached figures: 1. Blood vessel body; 2. Stenosis simulation unit; 3. Movable sleeve; 4. Elastic element; 5. External fixation sleeve. Detailed Implementation
[0011] To make the objectives, technical solutions, and advantages of this utility model clearer, the embodiments of this utility model will be described in further detail below with reference to the accompanying drawings.
[0012] Example 1 This embodiment provides an in vitro vascular model including a stenotic region, see [link / reference]. Figure 1 , Figure 2 As shown, the model includes: The blood vessel body 1 is made of a flexible material, specifically silicone or thermoplastic polyurethane. The shape of the internal cavity of the blood vessel body 1 can be biomimetically designed according to the anatomical structure of real blood vessels, and a narrow section is pre-formed in the middle. Narrow simulation unit 2, see Figure 3 , Figure 4 As shown, the stenosis simulation unit 2, fitted onto the outside of the blood vessel body 1 and corresponding to the narrowed portion thereon, sequentially includes an inner movable sleeve 3, an elastic element 4, and an outer fixed sleeve 5 from the inside out. The inner movable sleeve 3 is fitted tightly against the outer wall of the narrowed portion of the blood vessel body 1 and has a segmented, split structure, consisting of multiple circumferentially distributed flaps. This design allows each flap to move independently, better adapting to the irregular shape changes of the blood vessel body during device expansion, ensuring uniform and realistic pressure transmission. The inner movable sleeve 3 is connected to the outer fixed sleeve 5 via the elastic element 4, which can be a coil spring, butterfly spring, or elastic rubber column, etc., providing elastic force. Each flap of the inner movable sleeve 3 is connected to the outer fixed sleeve 5 via two sets of elastic elements, and the outer fixed sleeve 5 has a cylindrical structure.
[0013] Furthermore, the inner movable sleeve 3 and the outer fixed sleeve 5 are made of stainless steel or other metal materials.
[0014] Furthermore, both ends of the blood vessel body 1 and the lower end of the outer fixation sleeve 5 of the stenosis simulation unit are fixedly connected to the base set at the lower end, providing stable support.
[0015] Furthermore, the stenosis simulation unit 2 is a detachable structure that can be removed from the blood vessel body 1 as a whole, making it convenient to replace elastic elements with different stiffness (k value), different numbers, or different pre-compression amounts, thereby achieving rapid and quantitative adjustment of the stenosis constraint force over a wide range.
[0016] This invention provides an extracorporeal vascular model including a stenotic region. During use, as blood containing calcified plaques flows through the vascular body, when it enters the stenotic region, the calcified plaques compress and deform, causing the flaps of the inner movable sleeve 3 of the corresponding stenotic unit 2 to undergo radial displacement. This provides a realistic and quantitatively adjustable radial constraint force for the expansion of interventional devices. Furthermore, this invention can effectively simulate different lesions, from soft plaques to severely calcified hard plaques, making it more applicable.
[0017] The beneficial effects of this invention, which includes an extracorporeal vascular model containing a narrowed region, are as follows: 1. Highly simulated mechanical environment: Through the mechanical structure of elastic elements and inner movable sleeve, a realistic and quantitatively adjustable radial constraint force is provided for the expansion of interventional devices, which can effectively simulate different lesions from soft plaques to severely calcified hard plaques.
[0018] 2. Quantitatively adjustable constraint force: By replacing standardized elastic elements, the constraint force in narrow areas can be precisely and quantitatively adjusted, meeting the diverse needs of different testing standards and R&D stages for lesion stiffness.
[0019] 3. Ingenious structure and strong versatility: The segmented inner movable sleeve design ensures good fit and force transmission with the blood vessel body. This model has a compact structure, is easy to manufacture and assemble, and can be widely used in the in vitro testing of cardiovascular, neurovascular, and peripheral vascular interventional devices.
[0020] 4. Easy to operate: The detachable modular design makes it very easy to replace the lesion model (i.e., replace the stenosis simulation unit or just the spring), which greatly improves the testing efficiency.
[0021] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.
Claims
1. An in vitro vascular model including a narrowed region, characterized in that, It includes: The blood vessel body is made of a flexible material and can be pre-formed with narrow sections; The stenosis simulation unit is sleeved on the outside of the blood vessel body and is set corresponding to the stenosis portion thereon. It includes an inner movable sleeve, an elastic element and an outer fixed sleeve in sequence from the inside to the outside. The inner movable sleeve has a split structure and is set close to the outer wall of the blood vessel body. The inner movable sleeve is connected to the outer fixed sleeve through the elastic element.
2. An in vitro vascular model including a stenotic region according to claim 1, characterized in that, The inner movable sleeve is a split structure consisting of multiple lobes distributed circumferentially.
3. An in vitro vascular model including a stenotic region according to claim 1, characterized in that, The elastic element is a helical spring, a butterfly spring, or an elastic rubber column, and the flaps of each inner movable sleeve are connected to the outer fixed sleeve through two sets of elastic elements.
4. An in vitro vascular model including a stenotic region according to claim 1, characterized in that, The narrow portion of the blood vessel body is located in its central position, and the blood vessel body is made of silicone or thermoplastic polyurethane material.