Vessel modification balloon dilation model device

Abstract

The present disclosure provides a vascular modification balloon expansion model device, comprising a plaster model, which is tubular with a hollow part for inserting a scored balloon; a first connecting part provided outside the plaster model, one side of the first connecting part being provided with a first slot for accommodating the plaster model; a second slot provided in the first connecting part; and a positioning mechanism provided in the second slot to fix the plaster model in the first connecting part. The first connecting part provides a space for accommodating the plaster model; the provision of the second slot enables the positioning mechanism to find a suitable fixing position, ensuring the stability of the plaster model during processing; and the use of multiple positioning mechanisms can achieve accurate positioning of multiple fixing points of the plaster model, further improving the stability of the fixing.

Description

Technical Field

[0001] This disclosure relates to the field of balloon dilation detection, and more particularly to a vascular-modified balloon dilation model device. Background Technology

[0002] Blood vessel blockage is mainly caused by yellowish-white, porridge-like plaques embedded in the inner layer of the blood vessel wall. Blood vessel blockage reduces blood flow through the blood vessels, leading to various serious complications.

[0003] Interventional vascular therapy is an important treatment method for the aforementioned conditions. In interventional vascular therapy, balloon catheters are commonly used as the interventional device. Given the large number of commercially available vascular scoring balloon dilation catheters, understanding their dilation and scoring effects is crucial. However, information regarding the degree of dilation and the effect on calcified blood vessels for most products on the market remains relatively vague. This presents a challenge for physicians in selecting the appropriate treatment tool. Summary of the Invention

[0004] This disclosure provides a vascular modification balloon dilation model device to at least solve the above-mentioned technical problems existing in the prior art.

[0005] According to a first aspect of this disclosure, a vascular modification balloon dilation model device is provided, comprising a plaster model, the plaster model being tubular with a hollow central portion for inserting a notched balloon. A first connecting part is disposed on the outside of the plaster model. A first slot for accommodating the plaster model is provided on one side of the first connecting part. The first slot extends into the interior of the first connecting part along a first direction. The second slot is disposed in the first connecting part. There are multiple second slots, which are arranged along the first direction. The second slots are connected to the first slot. A positioning mechanism is provided in the second slot to fix the plaster model in the first connecting part; The positioning mechanisms include, A first movable component is slidably disposed in a second slot along a second direction. A through hole is provided in the middle of the first movable component, and the axial direction of the through hole is the same as that of the first direction. A limiting member is provided on the first movable member. The limiting member moves radially along the inner wall of the through hole to contact the plaster model, thereby limiting the plaster model. A snap-fit ​​element is disposed within a first connecting portion, the snap-fit ​​element being configured to restrict the sliding of a first movable member relative to the first connecting portion.

[0006] Furthermore, the limiting member includes a third groove, which is disposed within the first movable member and communicates with a through hole; A connecting plate is slidably disposed in a third slot. There are at least two connecting plates, which are evenly distributed around a through hole in the circumference. The connecting plates are slidably disposed in the third slot in the radial direction along the through hole. The connecting plate includes a first state and a second state. An airbag is fixedly mounted on a connecting plate, located on the side of the connecting plate near the center of the through hole, and filled with gas. A driving component is disposed within a first movable component. The driving component drives the connecting plate to switch between a first state and a second state. In the first state of the connecting plate, the connecting plate drives the airbag to be located in the third slot. In the second state of the connecting plate, the connecting plate drives the airbag to be located in the through hole.

[0007] Furthermore, the driving component includes a sealing hole, which is formed within the first movable component, communicates with the third slot, and extends radially along the through hole; A piston rod, one end of which is slidably disposed in a sealing hole, and the other end of which is fixedly connected to a connecting plate; The air tube has one end connected to an external air pump and the other end connected to a sealing hole.

[0008] Furthermore, the snap-fit ​​component includes a friction block, which is fixedly installed in the first connecting portion, located between two adjacent second slots, and in contact with the first movable component.

[0009] Furthermore, the third groove is an arc-shaped groove.

[0010] Furthermore, the gap between the inner wall of the third groove and the periphery of the connecting plate is 0.1mm-0.2mm, and the connecting plate portion is always located within the third groove.

[0011] Furthermore, an elastic cloth is provided between adjacent first movable parts. The elastic cloth is cylindrical, and the inner diameter of the side of the elastic cloth connected to the first movable part is the same as the inner diameter of the through hole.

[0012] A method for manufacturing plaster models, specifically applied to plaster models: S1. A mold for processing plaster models; S2. Mix 22.5g of plaster with 15ml of water and pour the mixture into the mold in S1. S3. Place the mold into which the mixture was injected in S2 into a constant temperature oven to dry; S4. After drying, remove the core material of the plaster model from the mold; S5. Dry again in a constant temperature oven at 60℃ for 0.5 to 1 day; S6. Pull out the 10cm long plaster tube from the mold and cut it to about 10mm in length.

[0013] An evaluation method for a vascular-modified balloon dilation model device, applied to the vascular-modified balloon dilation model device, specifically includes: S1. Place multiple plaster models into the first connecting part; S2. Position the plaster model within the first connecting part using the positioning mechanism; S3. Place the indented ball of the sample in the center of the plaster model; S4. Using a pressure pump, apply pressure to the inside of the scoring balloon, starting from 0 atm and gradually applying pressure to the sample in increments of 1 atm, then hold for 5 seconds. S5. If the plaster model is not damaged, apply another 1 atm of pressure and hold for 5 seconds.

[0014] S6. Repeat step S5 until the plaster model is damaged, and record the pressure at the time of damage.

[0015] Compared to existing technologies, the vascular modification balloon dilation model device and evaluation method disclosed herein have the following beneficial effects: the first connecting part provides a space to accommodate the plaster model; the setting of the second slot allows the positioning mechanism to find a suitable fixing position, ensuring the stability of the plaster model during processing; and through the coordinated use of multiple positioning mechanisms, precise positioning of multiple fixing points of the plaster model can be achieved, further improving the stability of the fixation. Simultaneously, the main function of the first movable component in the positioning mechanism is to slide in the second direction to automatically match different curved plaster models, thereby achieving precise positioning and fixation of the plaster model. The through hole in the middle of the first movable component is used for inserting the plaster model, ensuring smooth and centered fixation. When it is necessary to fix plaster models with different degrees of curvature, the operator inserts the plaster model into the first slot, and then into the through hole of the first movable component. By adjusting the position of the first movable component in the second slot, the through hole of the first movable component adapts to plaster models with different curvature angles. Then, the positioned plaster model is expanded and tested using a scoring balloon.

[0016] It should be understood that the description in this section is not intended to identify key or essential features of the embodiments of this disclosure, nor is it intended to limit the scope of this disclosure. Other features of this disclosure will become readily apparent from the following description. Attached Figure Description

[0017] The above and other objects, features, and advantages of this disclosure will become readily apparent from the following detailed description of exemplary embodiments, taken in conjunction with the accompanying drawings. Several embodiments of this disclosure are illustrated in the drawings by way of example and not limitation, in which: In the accompanying drawings, the same or corresponding reference numerals indicate the same or corresponding parts.

[0018] Figure 1 A first schematic diagram of the overall structure of this disclosure is shown; Figure 2 A second schematic diagram of the overall structure of this disclosure is shown; Figure 3 A cross-sectional view of the first connecting portion of this disclosure is shown; Figure 4 A cross-sectional view of the first connecting part of this disclosure and the plaster model is shown; Figure 5 This disclosure shows that Figure 4 Enlarged view of a portion of the structure at point A; Figure 6 A first schematic diagram of the positioning mechanism disclosed herein is shown; Figure 7 A second schematic diagram of the positioning mechanism of this disclosure is shown.

[0019] Explanation of the labels in the diagram: 1. Plaster model; 2. First connecting part; 3. First slot; 4. Second slot; 5. Positioning mechanism; 51. First moving part; 52. Through hole; 53. Snap-fit ​​part; 531. Friction block; 532. Friction layer; 54. Limiting part; 541. Third groove; 542. Connecting plate; 543. Airbag; 544. Driving part; 5441. Sealing hole; 5442. Piston rod; 6. Elastic fabric; 7. Base. Detailed Implementation

[0020] To make the objectives, features, and advantages of this disclosure more apparent and understandable, the technical solutions in the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0021] Vascular plaques, also known as atherosclerotic plaques, can exist within human blood vessels due to various reasons. These are yellowish-white, porridge-like lumps embedded in the inner layer of the arterial walls. Factors such as aging, lack of exercise, smoking, alcohol consumption, high cholesterol, high blood pressure, diabetes, and obesity can all contribute to the formation of vascular plaques.

[0022] If plaques are left to grow unchecked, they can lead to coronary artery blockage, causing angina or even myocardial infarction. Generally, once arterial plaques are detected, they should be treated aggressively, such as using medications to control blood lipids and cholesterol to inhibit plaque growth. When the narrowing of blood vessels becomes severe enough to affect normal blood supply, an evaluation is needed to determine whether surgery is necessary. Two common surgical methods are endarterectomy and lumenoplasty. For plaques in some blood vessels, such as those in the brain, removal is not possible. In these cases, surgeons may use balloons or stents to dilate the narrowed vessels to maintain blood flow in the diseased vessels.

[0023] Therefore, given the large number of vascular scoring balloon dilation catheters already on the market, understanding their dilation and scoring effects is crucial. However, information regarding the degree of dilation and the effectiveness of most products on calcified blood vessels remains relatively vague. This presents a challenge for physicians when selecting appropriate treatment tools.

[0024] To fill this gap, researchers began experimenting with standardized models, such as plaster casts depicting calcified lesions. This allows for the testing of different brands of balloon dilation catheters under strictly controlled conditions, enabling a more accurate evaluation of their dilation and scoring effects. This evaluation method helps reveal the performance differences of different balloons in actual operation, providing a more scientific basis for clinical applications.

[0025] Specifically, a vascular modification balloon dilation model device includes a plaster model 1, which is tubular with a hollow center to accommodate a notched balloon. The notched balloon expands within the tubular structure, generating uniform pressure on the inner wall of the tubular structure, thereby testing the dilation and notching effects of different notched balloons on calcified blood vessels. In practical applications, the pressure distribution inside the tubular model can be precisely controlled by adjusting the expansion force of the notched balloon, thus better simulating and treating deformation problems of complex tubular structures.

[0026] Please see Figure 2 and Figure 3The first connecting part 2 is located on the outside of the plaster model 1. A first slot 3 for accommodating the plaster model 1 is formed on one side of the first connecting part 2. The first slot 3 extends into the interior of the first connecting part 2 along a first direction, which is the length direction of the first connecting part 2, that is, the direction in which the plaster model 1 is inserted into the first slot 3. The first connecting part 2 is made of transparent material, specifically, it is made of high-transmittance polycarbonate material (transmittance ≥90%), which facilitates real-time observation of the state of the plaster model during the balloon expansion process (such as crack formation and deformation).

[0027] The first connecting part 2 mainly serves to fix and protect the plaster model 1. By providing a first groove 3 on one side of the first connecting part 2, the plaster model 1 can be partially or completely contained in the first groove, fixing the plaster model 1 in a specific position or shape and preventing it from moving or deforming when subjected to external forces. Since the first groove 3 extends into the interior of the first connecting part 2 along a specific direction (first direction), the hollow axis of the plaster model 1 overlaps with or is parallel to the first direction.

[0028] The first connecting part 2 is provided with a base 7 on its lower side. The first connecting part 2 is rotatably mounted on the base 7, so that when the plaster model is inserted into the first slot 3 of the first connecting part, the first connecting part 2 can be in a vertical state, which makes it easier to adjust the insertion angle and also makes it easier to insert the plaster model 1.

[0029] Please see Figure 3 and Figure 4 The second slot 4 is disposed in the first connecting part 2. There are multiple second slots 4, which are arranged along the first direction. The second slots 4 are connected to the first slot 3. Positioning mechanism 5 is set in the second slot 4 to fix the plaster model 1 in the first connecting part 2; multiple positioning mechanisms are evenly distributed at intervals of 5mm-10mm along the first direction.

[0030] The second slot 4 is located inside the first connecting part 2 and multiple slots are arranged along the first direction to ensure that different parts of the plaster model 1 can be effectively positioned and fixed. The positioning mechanism 5 is embedded in these second slots 4 to firmly fix the position of the plaster model 1. Specifically, the first connecting part 2 provides a space to accommodate the plaster model 1; the arrangement of the second slots 4 allows the positioning mechanism 5 to find a suitable fixing position, ensuring the stability of the plaster model 1 during processing; and through the coordinated use of multiple positioning mechanisms 5, precise positioning of multiple fixing points of the plaster model 1 can be achieved, further improving the stability of the fixation and ensuring the stable conduct of the expansion experiment of the indented balloon in the plaster model.

[0031] The plaster model 1 comes in various forms. Depending on the actual situation of calcified blood vessels, the plaster model 1 is sometimes injection molded into a curved shape to simultaneously meet the positioning requirements of either curved or straight plaster model 1.

[0032] Please see Figures 4-6 The positioning mechanism 5 includes a first movable part 51, which is slidably disposed in the second slot 4 along a second direction (where the second direction is the radial direction of the through hole 52, that is, the direction perpendicular to the axis of the plaster model). The first movable part 51 has a through hole 52 in the middle, and the axis of the through hole 52 is in the same direction as the first direction. The first movable part 51 of each positioning mechanism 5 slides independently along the second direction, and the sliding displacement is adjusted by pressure feedback to ensure that the clamping pressure of all positioning mechanisms on the plaster model is consistent (0.1-0.3MPa).

[0033] The primary function of the first movable component 51 in the positioning mechanism 5 is to slide in the second direction to automatically match different curved plaster models 1, thereby achieving precise positioning and fixation of the plaster model 1. The through hole 52 in the middle of the first movable component 51 is used for inserting the plaster model 1, ensuring smooth and centered placement during fixation. In terms of working principle, when it is necessary to fix plaster models 1 with different degrees of curvature, the operator inserts the plaster model 1 into the first slot 3, and then into the through hole 52 of the first movable component 51. By adjusting the position of the first movable component 51 within the second slot 4, the through hole 52 of the first movable component 51 adapts to plaster models 1 with different curvature angles, facilitating the insertion of the scoring balloon into the plaster model for expansion experiments and reducing the shaking of the plaster model.

[0034] The limiting member 54 is disposed on the first movable member 51. The limiting member 54 moves radially along the inner wall of the through hole 52 and contacts the plaster model 1 to limit the plaster model 1. After the plaster model 1 is inserted into the through hole 52, the limiting member 54 performs the limiting operation on the plaster model 1.

[0035] Please see Figure 6 and Figure 7 Specifically, the limiting member 54 includes a third groove 541, which is disposed in the first movable member 51 and communicates with the through hole 52; wherein the third groove 541 can be an annular groove, or an arc-shaped groove or a square groove opened on the inner wall of the through hole 52.

[0036] There are at least two connecting plates 542, which are evenly distributed around the through hole 52. If there are only two connecting plates 542, the optimal position is that they are set opposite each other. The connecting plates 542 are slidably arranged in the third slot 541 along the through hole 52. The connecting plates 542 include a first state and a second state. In this embodiment, the connecting plates 542 are arc-shaped structures (the arc matches the outer wall of the plaster model, with a radius of 3mm-4mm) to better fit the surface of the plaster model 1.

[0037] Airbag 543 is fixedly installed on connecting plate 542. Airbag 543 is located on the side of connecting plate 542 near the middle of through hole 52. Airbag 543 is filled with gas. Airbag is connected to external pressure regulating valve through micro air tube (1mm inner diameter, PEEK material). Regulating valve stabilizes the pressure inside airbag at 0.1-0.3MPa. Airbag has built-in micro pressure safety valve (opening pressure 0.4MPa). When the pressure exceeds the threshold, it automatically releases pressure to prevent airbag rupture or premature damage to plaster model due to excessive compression.

[0038] The airbag 543 primarily reduces the pressure of the connecting plate 542 on the plaster model 1, ensuring uniform stress distribution. Simultaneously, the airbag 543 simulates the pressure of the vascular wall on calcifications, thus better replicating vascular occlusion conditions. A key drawback of directly fixing the plaster model (e.g., using metal clamps or rigid clasps) is the lack of elastic containment from the vascular wall. In real blood vessels, calcifications are not isolated but tightly encased by the elastic vascular wall (intima + media). The vascular wall exerts continuous radial constraint pressure on the calcifications through its elasticity (normal arterial wall static pressure is approximately 0.1-0.3 atm, which may rise to 0.3-0.5 atm in calcified lesions due to vascular stiffness). This constraint directly affects the rupture mode and extent of calcifications during balloon dilation. The design of the airbag 543 precisely compensates for this crucial deficiency.

[0039] Compared to direct fixation, where the plaster model is rigidly constrained, the plaster fractures suddenly and brittlely when compressed by the scoring balloon due to the lack of elastic buffering (randomly distributed cracks and irregular fracture surfaces). This is completely inconsistent with the clinical phenomenon of "progressive rupture of calcifications under the elastic buffering of the blood vessel wall" (the scoring knife first cuts the weak point of the calcification and then slowly expands along the cutting line). The balloon 543, through its flexible structure filled with gas, can simulate the elastic characteristics of the blood vessel wall: when the scoring balloon compresses the plaster model, the balloon stretches / compresses synchronously with the slight deformation of the plaster, applying continuous constraint pressure to the plaster through elastic reaction force, forcing the calcification (plaster) to rupture along the cutting path of the scoring knife. The rupture mode is highly consistent with the clinical phenomenon of "orderly rupture of calcifications under the elastic constraint of the blood vessel wall," making the test results more clinically valuable.

[0040] The driving component 544 is disposed within the first movable component 51. The driving component 544 drives the connecting plate 542 to switch between a first state and a second state. In the first state, the connecting plate 542 drives the airbag 543 to be located in the third slot 541. In the second state, the connecting plate 542 drives the airbag 543 to be located in the through hole 52.

[0041] The third slot 541 connects to the through hole 52, allowing the third slot 541 to accommodate the fixing plate 542 and providing a sliding path for movement along the through hole 52. The connecting plate 542, as a key component, consists of at least two plates evenly distributed around the through hole 52. These plates can drive the airbag 543 to slide radially along the through hole 52, thus fixing the plaster model 1.

[0042] Please see Figure 6 and Figure 7 The connecting plate 542 has two states: In the first state, the connecting plate 542 drives the airbag 543 to be located in the area of ​​the third slot 541, thus not participating in the fixation of the plaster model 1. At this time, the plaster model 1 can move freely in the through hole 52 without resistance. In the second state, the connecting plate 542 drives the airbag 543 to slide into the through hole 52, causing the airbag 543 to occupy the space in the through hole 52. At this time, the plaster model 1 is already in the through hole 52, so the airbag 543 contacts the outer wall of the plaster model 1 and fixes the plaster model 1. At the same time, the airbag 543 provides an elastic effect. When in contact with the plaster model 1, the airbag 543 disperses the clamping force of the connecting plate 542 on the plaster model 1, so that the plaster model 1 is subjected to uniform force. At the same time, the airbag 543 has the function of simulating blood vessels, and can generate pressure on the outside of the plaster model 1, that is, blood vessel pressure.

[0043] The driving component 544 includes a sealing hole 5441, which is located within the first movable component 51 and communicates with the third slot 541. The sealing hole 5441 extends radially along the through hole 52. A piston rod 5442 is slidably disposed at one end within the sealing hole 5441. A nitrile rubber O-ring (model AS568-010, hardness 70 Shore A) is fitted onto the outer wall of the piston rod 5442. The O-ring is interference-fitted with the inner wall of the sealing hole 5441 (interference amount 0.05mm). A fluororubber sealing gasket (thickness 2mm, aging resistance ≥5 years) is provided at the connection between the sealing hole 5441 and the third slot 541. To prevent gas leakage from the connecting gap, the other end of the piston rod 5442 is fixedly connected to the connecting plate 542; the air pipe has one end connected to an external air pump and the other end connected to the sealing hole 5441. The air pipe is connected in series with a miniature solenoid valve (response time ≤10ms) and a flow meter (range 0-100ml / min, accuracy ±1ml / min). The solenoid valve is electrically connected to the external control system. The inflation volume is adjusted by the gas flow feedback from the flow meter to achieve precise control of the piston rod movement distance (adjusted by 0.5-1mm each time).

[0044] A sealing hole 5441 is formed within the first movable member 51, ensuring a tight seal while allowing the piston rod 5442 to slide within it. One end of the piston rod 5442 is slidably disposed within the sealing hole 5441, while the other end is fixedly connected to the connecting plate 542, thereby enabling the movement of the connecting plate 542. An external air pump is connected via an air pipe, the other end of which is connected to the sealing hole 5441, allowing the air from the pump to be directly delivered into the sealing hole 5441. When the external air pump supplies air, the piston rod 5442 moves within the sealing hole 5441, thereby moving the connecting plate 542. When the air bladder 543 on the connecting plate 542 contacts the plaster model 1, the connecting plate 542 will no longer move, at which point the pressure within the sealing hole 5441 increases. When the pressure increases to a certain value, the air pump will stop filling the system to maintain a stable pressure. When it is not necessary to fix the plaster model 1, the air pump draws in air, and the pressure decreases through the air pipe sealing hole 5441. The piston rod 5442 will retract into the sealing hole 5441, which in turn drives the connecting plate 542 to retract into the third slot 541.

[0045] Please see Figure 6 and Figure 7 After clamping the plaster model 1, in order to reduce the movement of the first movable part 51, it is necessary to fix the first movable part 51. Specifically, a snap-fit ​​part 53 is provided, which is disposed in the first connecting part 2. The snap-fit ​​part 53 allows the first movable part 51 to switch between a first state and a second state. In the first state, the first movable part 51 is in a sliding state relative to the first connecting part 2. In the second state, the first movable part 51 is in a stationary state relative to the first connecting part 2.

[0046] The snap-fit ​​element 53 is disposed inside the first connecting part 2. Its function is to restrict the sliding of the first movable element 51 relative to the first connecting part 2, thereby enhancing the stability of the connection structure and reducing the shaking of the plaster model 1.

[0047] Specifically, the snap-fit ​​component 53 includes a friction block 531, which is fixedly installed within the first connecting portion 2. The friction block 531 is located between two adjacent second slots 4 and contacts the first movable component 51. The friction block is made of nitrile rubber with a Shore A hardness of 70 (coefficient of friction ≥ 0.6, wear resistance ≥ 500 sliding cycles), and the contact area of ​​the friction block is 15 mm² (10 mm long × 1.5 mm wide). The friction block 531 plays a crucial limiting role in the first connecting part 2. It is fixedly installed within the first connecting part 2 and located between two adjacent second slots 4, ensuring that the first movable part 51 can slide along a predetermined path, but cannot slide easily; that is, there is resistance to the sliding of the first movable part 51 within the first connecting part 2. The friction block 531 contacts the first movable part 51, increasing the frictional force to restrict the sliding freedom of the first movable part 51, thereby ensuring the stability of the first movable part 51 in a specific position. To further enhance stability, a friction layer 532 is provided on the side of the first movable part 51 near the friction block 531, thereby increasing the frictional force. The friction layer is an alumina ceramic coating sprayed on the surface of the first movable part (thickness 50μm, surface roughness Ra≤0.8μm, and coefficient of friction with nitrile rubber stable at 0.6-0.8).

[0048] Plaster model 1 is set inside the first connecting part 2, and multiple plaster models 1 can be inserted. Then, a scoring balloon is inserted to conduct tests in sequence, thereby observing the pressure of multiple plaster models 1, which is more corresponding and makes the data more intuitive.

[0049] The gap between the inner wall of the third slot 541 and the periphery of the connecting plate 542 is 0.1mm-0.2mm, and the connecting plate 542 is always located within the third slot 541. The sliding surface of the connecting plate is coated with a polytetrafluoroethylene lubricating coating (thickness 5-10μm, coefficient of friction ≤0.1) to ensure smooth sliding without jamming.

[0050] An elastic cloth 6 is provided between adjacent first movable parts 51. The elastic cloth 6 is cylindrical and made of polyurethane fiber material. The inner diameter of the side of the elastic cloth 6 connected to the first movable part 51 is the same as the inner diameter of the through hole 52. Thus, the broken plaster model 1 will be located inside the through hole 52 and the elastic cloth. The broken plaster model 1 can be poured out simply by tilting the first connecting part 2, which is convenient for cleaning.

[0051] A method for manufacturing a plaster model 1, applied to the aforementioned plaster model 1, specifically includes S1, processing a mold for the plaster model 1; S2. Mix 22.5g of plaster with 15ml of water and pour the mixture into the mold in S1. S3. Place the mold into which the mixture was injected in S2 into a constant temperature oven to dry; S4. After drying, remove the core material of plaster model 1 from the mold; S5. Dry again in a constant temperature oven at 60℃ for 0.5 to 1 day; S6. Pull out the 10cm long plaster tube from the mold and cut it to about 10mm in length.

[0052] An evaluation method for a vascular-modified balloon dilation model device, applied to the aforementioned vascular-modified balloon dilation model device; S1. Place the plaster model 1 into the first connecting part 2; S2. Position the plaster model 1 within the first connecting part 2 using the positioning mechanism 5; S3. Place the indented ball of the sample in the center of plaster model 1; S4. Using a pressure pump, apply pressure to the inside of the scoring balloon, starting from 0 atm and gradually applying pressure to the sample in increments of 1 atm, then hold for 5 seconds. S5. If plaster model 1 is not damaged, apply another 1 atm of pressure and hold for 5 seconds.

[0053] S6. Repeat the operation of S5 until plaster model 1 is damaged, and record the pressure when plaster model 1 is damaged.

[0054] It should be understood that the various forms of processes shown above can be used to rearrange, add, or delete steps. For example, the steps described in this disclosure can be executed in parallel, sequentially, or in different orders, as long as the desired result of the technical solution disclosed in this disclosure can be achieved, and this is not limited herein.

[0055] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this disclosure, "a plurality of" means two or more, unless otherwise explicitly specified.

[0056] The above description is merely a specific embodiment of this disclosure, but the scope of protection of this disclosure is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this disclosure should be included within the scope of protection of this disclosure. Therefore, the scope of protection of this disclosure should be determined by the scope of the claims.

Claims

1. A vascular-modified balloon dilation model device, characterized in that, Includes a plaster model (1), which is tubular with a hollow center to accommodate a notched spherical bladder; The first connecting part (2) is provided on the outside of the plaster model (1). A first slot (3) for accommodating the plaster model (1) is provided on one side of the first connecting part (2). The first slot (3) extends into the interior of the first connecting part (2) along a first direction. The second slot (4) is disposed in the first connecting part (2). There are multiple second slots (4), and the multiple second slots (4) are arranged along the first direction. The second slots (4) are connected to the first slot (3). Positioning mechanism (5), which is set in the second slot (4) to fix the plaster model (1) in the first connecting part (2); The positioning mechanism (5) includes, The first movable part (51) is slidably disposed in the second slot (4) along the second direction. The first movable part (51) has a through hole (52) in the middle. By adjusting the position of the first movable part (51) in the second slot (4), the through hole (52) of the first movable part (51) can be adapted to plaster models (1) with different bending angles. A limiting member (54) is provided on the first movable member (51). The limiting member (54) moves radially along the inner wall of the through hole (52) until it contacts the plaster model (1) to limit the plaster model (1). A snap-fit ​​member (53) is disposed within the first connecting portion (2). The first movable member (51) includes a first state and a second state. The snap-fit ​​member (53) allows the first movable member (51) to switch between the first state and the second state. In the first state, the first movable member (51) is in a sliding state relative to the first connecting portion (2). In the second state, the first movable member (51) is in a stationary state relative to the first connecting portion (2). The limiting member (54) includes, The third slot (541) is disposed in the first movable part (51) and is connected to the through hole (52); A connecting plate (542) is radially slidably disposed in a third slot (541) along a through hole (52), and the connecting plate (542) includes a first state and a second state. An airbag (543) is fixedly installed on a connecting plate (542). The airbag (543) is located on the side of the connecting plate (542) near the middle of the through hole (52). The airbag (543) is filled with gas. The airbag (543) simulates the elastic properties of the blood vessel wall through its flexible structure filled with gas. A driving component (544) is disposed within a first movable component (51). The driving component (544) drives a connecting plate (542) to switch between a first state and a second state. In the first state of the connecting plate (542), the connecting plate (542) drives an airbag (543) to be located within a third slot (541). In the second state of the connecting plate (542), the connecting plate (542) drives an airbag (543) to be located within a through hole (52). The snap-fit ​​component (53) includes a friction block (531), which is fixedly installed in the first connecting part (2). The friction block (531) is located between two adjacent second slots (4) and is in contact with the first movable part (51).

2. The vascular modification balloon dilation model device according to claim 1, characterized in that, The drive unit (544) includes, A sealing hole (5441) is formed in the first movable part (51), the sealing hole (5441) is connected to the third slot (541), and the sealing hole (5441) extends radially along the through hole (52). A piston rod (5442) is slidably disposed in a sealing hole (5441) at one end, and the other end of the piston rod (5442) is fixedly connected to a connecting plate (542). The air tube has one end connected to an external air pump and the other end connected to a sealing hole (5441).

3. The vascular modification balloon dilation model device according to claim 1, characterized in that, The first movable part (51) has a friction layer (532) on the side near the friction block (531).

4. The vascular modification balloon dilation model device according to claim 1, characterized in that, There are at least two connecting plates (542), and the two connecting plates (542) are evenly distributed around the through hole (52) in the circumference.

5. The vascular modification balloon dilation model device according to claim 1, characterized in that, The third slot (541) is an arc-shaped slot.

6. The vascular modification balloon dilation model device according to claim 1, characterized in that, The gap between the inner wall of the third slot (541) and the periphery of the connecting plate (542) is 0.1mm-0.2mm, and the connecting plate (542) is always located inside the third slot (541).

7. The vascular modification balloon dilation model device according to claim 6, characterized in that, An elastic cloth (6) is provided between adjacent first movable parts (51). The elastic cloth (6) is cylindrical. The inner diameter of the side of the elastic cloth (6) connected to the first movable part (51) is the same as the inner diameter of the through hole (52).

8. The vascular modification balloon dilation model device according to claim 7, characterized in that, The elastic fabric (6) is made of polyurethane fiber material.

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