A bridging and anti-bridging treatment of a plug-in type cerebral apoplexy simulation model establishment device and method

Abstract

The application discloses a bridging and anti-bridging treatment stent plug type cerebral stroke simulation model establishment device and method, and belongs to the field of medical instruments, which comprises a sleeve with a conveying channel extending along the length direction, the conveying channel having a distal end opening for inserting into a blood vessel; a stent plug assembly movably arranged in the conveying channel, the stent plug assembly comprising a guide wire, a support platform and a positioning cap, the positioning cap being arranged at the distal end of the guide wire, and the support platform being arranged on the guide wire and axially spaced apart from the positioning cap; and an autologous thrombus simulation object sleeved on the guide wire and located between the positioning cap and the support platform; wherein the outer periphery of the positioning cap is provided with an inflatable anchoring component, which can abut against the inner wall of the target main blood vessel to limit the axial movement of the stent plug assembly when in the inflated state. Through the above arrangement, the application can integrate real thrombus pathological elements and simulate the clinical ischemic cerebral stroke bridging treatment process on a single experimental object in a streamlined manner.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a device and method for establishing a thromboembolic stroke simulation model for bridging and anti-bridging therapy. Background Technology

[0002] Animal models are an effective means of studying the pathophysiological mechanisms of ischemic stroke and are often used to evaluate the safety and effectiveness of intravenous thrombolysis, mechanical thrombectomy, and bridging-reverse bridging therapy. Currently, the mainstream experimental methods for constructing occlusion models of blood vessels such as the middle cerebral artery are mainly divided into two categories: mechanical occlusion models and autoembolization models.

[0003] Mechanical occlusion models simulate vascular embolism by pushing a solid, thread-like object into the target blood vessel, thus physically blocking it. Their advantage lies in the precise location of the occlusion and the reversibility of the operation. However, their drawback is that the simulated embolic material is inorganic and cannot reflect the biological and rheological properties of real thrombi. Therefore, this type of model cannot be used to evaluate the direct dissolving effect of thrombolytic drugs on thrombi, which limits its research value.

[0004] Secondly, there is the autologous thromboembolism model, which uses an in vitro prepared autologous blood clot injected into a blood vessel to achieve a simulation effect closer to the clinical pathological state. Although real thrombus components are used, in actual operation, the location and morphology of the injected thrombus are difficult to control. The thrombus is prone to uncontrollable displacement or fragmentation under the impact of blood flow, causing distal embolism. This results in a low simulation success rate and poor reproducibility, which in turn affects the standardization of the experimental process and the reliability of the experimental results.

[0005] As clinical stroke treatment strategies become increasingly complex, intravenous thrombolysis combined with mechanical thrombectomy has become a standard treatment approach. This places higher demands on animal simulation models: they not only need to simulate a single occlusion state, but also need to continuously simulate the series of key clinical interventions—vascular embolism, intravenous thrombolysis, thrombectomy, and drug re-intervention—throughout the entire experimental process.

[0006] However, current mechanical occlusion models cannot be used for realistic drug thrombolysis testing; while autologous thrombus models struggle to integrate embolization, in vivo drug exposure, thrombectomy, and re-intervention for residual embolism in a single experiment. Attempting to simulate the entire process often requires researchers to use multiple instruments sequentially to enter and exit the target vessel, or even change animal models, resulting in cumbersome experimental procedures and discrepancies between the transitions between stages compared to real clinical scenarios, making it difficult to efficiently achieve standardized treatment simulation. Summary of the Invention

[0007] To overcome the problems mentioned in the background art, this invention proposes a device and method for establishing a thrombus-based stroke simulation model for bridging and anti-bridging therapy. By setting up a slidable and detachable cannula and thrombectomy assembly, it can sequentially simulate the construction of a thrombus model, intravenous drug intervention, mechanical thrombectomy, and post-thrombectomy drug intervention. It integrates real thrombus pathological elements and simulates the clinical ischemic stroke bridging therapy process in a streamlined manner on a single experimental subject, providing a superior tool for related basic and translational research.

[0008] The device for the simulation model of the present invention specifically includes: a cannula, a thrombus placement assembly, and an autologous thrombus simulator; The cannula has a delivery channel extending along its length, the delivery channel having a distal opening for insertion into a blood vessel; The bolus placement assembly is movably disposed in the delivery channel. The bolus placement assembly includes a guide wire, a support platform, and a positioning cap. The positioning cap is disposed at the distal end of the guide wire, and the support platform is disposed on the guide wire and spaced axially from the positioning cap. The autologous thrombus simulator is fitted onto the guidewire and positioned between the positioning cap and the support platform; The positioning cap has an inflatable anchoring component on its outer periphery. When inflated, the anchoring component abuts against the inner wall of the target main blood vessel to restrict the axial movement of the thrombectomy assembly. A first one-way valve is provided in the delivery channel near the distal opening, allowing fluid to flow unidirectionally from the delivery channel into the blood vessel. A second one-way valve is provided at the distal end of the positioning cap, allowing fluid to flow unidirectionally from outside the positioning cap into the area between the positioning cap and the support platform.

[0009] Furthermore, the delivery channel also has a proximal opening located outside the body, the proximal opening including a first opening and a second opening, the delivery channel including a first branch channel and a second branch channel leading from the distal opening to the first opening and the second opening respectively, such that the cannula is Y-shaped; in use, the thrombectomy assembly is at least partially slidably disposed in the first branch channel, and can be delivered into a blood vessel via the first branch channel, or withdrawn outside the patient's body.

[0010] Furthermore, the thrombectomy assembly is movable between a first position and a second position; when in the first position, the thrombectomy assembly is housed within the delivery channel of the cannula; when in the second position, the thrombectomy assembly is at least partially located within the blood vessel, and the positioning cap and the support platform are respectively located on opposite sides of the entrance to a target branch blood vessel, so that the autologous thrombus mimicry, after dissolving, enters the target branch blood vessel driven by the blood flow passing through the positioning cap.

[0011] Furthermore, the anchoring component is a balloon surrounding the positioning cap; an inflation / deflation channel is formed inside the guidewire, one end of which communicates with the interior of the balloon, and the other end extends to the proximal end of the guidewire for connecting to an inflation / deflation device.

[0012] Furthermore, the positioning cap and the support platform each have a first conical surface and a second conical surface facing the proximal direction, respectively; along the axial direction of the guidewire, the minimum outer diameter of the first conical surface and the second conical surface is the same as the outer diameter of the guidewire, so that during the process of the thrombectomy assembly being withdrawn from the blood vessel to the delivery channel, it interacts with the first one-way valve in sequence and causes it to open.

[0013] Furthermore, the thrombus placement assembly also includes at least one limiting member located between the positioning cap and the support platform. A gap is formed on the limiting member, which can restrict the passage of the intact autologous thrombus simulant while allowing the passage of the dissolved autologous thrombus simulant.

[0014] Furthermore, the limiting member is a plurality of ribs extending radially; or, a mesh or grid structure surrounding the guidewire. The first one-way valve is selected from a valve valve, a duckbill valve, or a slit valve formed of an elastic material; the second one-way valve is integrated on the outer side of the positioning cap, the outer side of the positioning cap being a convex surface facing the blood vessel, a cavity is provided between the first conical surface and the outer side, the cavity being in one-way communication with the second one-way valve; and a flow channel is provided between the cavity and the first conical surface to allow blood flow in the contralateral vein to pass through the second one-way valve, enter the cavity, and move towards the autologous thrombus simulator after passing through the flow channel.

[0015] The method for establishing a simulation model based on the aforementioned device includes the following steps: S1. Constructing a vascular embolism model: The thrombus placement assembly carrying the autologous thrombus simulator is delivered into the target main blood vessel through the delivery channel of the cannula, with the positioning cap and the support platform located on opposite sides of the entrance of the target branch blood vessel, and the autologous thrombus simulator located at the entrance or proximal end; then the anchoring component is inflated to fix the thrombus placement assembly in the blood vessel to simulate a vascular embolism state; S2. Simulated intravenous drug intervention: With the thrombectomy assembly fixed in the blood vessel, thrombolytic drugs are administered intravenously; the blood flow carries the thrombolytic drugs through the second one-way valve into the area between the positioning cap and the support platform, where they come into contact with the autologous thrombus simulator, and after partially dissolving and fragmenting it, they are flushed into the target branch blood vessel to simulate intravenous thrombolytic therapy. S3. Simulated mechanical thrombectomy intervention: The thrombectomy assembly, together with the residual thrombus simulation material on it, is withdrawn from the body through the delivery channel to simulate a mechanical thrombectomy operation. S4. Simulated local drug re-intervention: After the thrombectomy assembly is withdrawn, thrombolytic drugs are infused into the target branch vessels through the delivery channel of the cannula and the first one-way valve, simulating local intra-arterial thrombolysis.

[0016] Further, in step S1, the delivery of the thrombectomy assembly specifically includes: placing the thrombectomy assembly in the first branch channel of the cannula and inserting the distal end of the cannula into the blood vessel; pushing the guidewire so that the positioning cap, the support platform, and the autologous thrombus simulator between them pass the entrance of the target branch blood vessel, and continuing to push the guidewire until the support platform moves to the proximal side of the entrance.

[0017] Furthermore, in step S2, after the thrombolytic drug is administered intravenously, the thrombolytic drug can enter the arterial system via the systemic circulation, and the blood flow propels the drug through the contralateral blood vessel, Willis ring, or collateral circulation to the location of the second one-way valve.

[0018] Furthermore, in step S3, before removing the bolt assembly, the anchoring component is first emptied to release the fixation.

[0019] The beneficial effects of this invention are: 1. This invention features a positioning cap integrating an inflatable anchoring component and a second one-way valve, as well as a support platform for carrying the autologous thrombus simulant. The thrombus placement assembly is stably anchored within the target main blood vessel via an inflatable anchoring balloon, and the autologous thrombus simulant is axially positioned via the support platform and positioning cap, thereby creating a precisely positioned in-situ thrombus model within the blood vessel. Simultaneously, the second one-way valve on the positioning cap, allowing fluid to flow unidirectionally from distal to proximal, provides a perfusion path for thrombolytic drugs to reach and act on the thrombus via collateral circulation during simulated intravenous thrombolysis, preventing reverse leakage of thrombus material. This makes the thrombus occlusion simulation of the blood vessel more controllable, effectively solving the problem of insufficient pathological simulation caused by the lack of a real thrombus in mechanical occlusion models, and avoiding the low success rate and poor repeatability issues caused by the easy displacement of autologous thrombus embolization models.

[0020] 2. This invention also includes a cannula with a first one-way valve, which cooperates with the thrombectomy assembly and the aforementioned features. The method for establishing the simulation model encompasses a continuous operational flow of constructing an embolism model → simulating intravenous thrombolytic drug intervention → simulating mechanical thrombectomy intervention → simulating arterial thrombolytic drug re-intervention. After the cannula and thrombectomy assembly are combined with the process steps, the mechanical thrombectomy stage can be simulated by withdrawing the entire thrombectomy assembly after intravenous thrombolysis. Subsequently, using the first one-way valve on the cannula that only allows fluid to flow unidirectionally into the blood vessel, drugs are locally infused into the target blood vessel through the cannula's independent channel, simulating intra-arterial drug administration and local drug re-intervention. With the cooperation of the device and method, the simulation of all treatment stages can be completed sequentially in a single continuous experimental operation, thus better solving the problem in existing technologies where the treatment process simulation is singular and unable to continuously simulate the complete chain of clinical bridging and anti-bridging treatment according to a standardized process on a single experimental subject. Attached Figure Description

[0021] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Wherein: Figure 1 This is a perspective view of an assembly structure according to the present invention; Figure 2 This is a three-dimensional view of a partial structure when the target main blood vessel is implanted according to the present invention; Figure 3 This is a right view of a partial structure of the present invention when the target main blood vessel is implanted; Figure 4 When the thrombus assembly moves to the second position Figure 3 Front view of the cross-sectional structure along the AA direction, A1-A1; Figure 5 for Figure 4 A schematic diagram of the local structure at point B; Figure 6 During the movement of the thrombus assembly from the second position to the first position, Figure 3 Front view of the cross-sectional structure along the AA direction, A2-A2; Figure 7 for Figure 6 A schematic diagram of the local structure at point C; Figure 8 When the embolization device is dislodged from the blood vessel Figure 3 Front view of the cross-sectional structure along the AA direction, A3-A3; Figure 9 for Figure 8A schematic diagram of the local structure at point D; In the diagram, 1. cannula; 11. delivery channel; 111. distal opening; 112. first opening; 113. second opening; 114. first one-way valve; 2. thrombus placement assembly; 21. positioning cap; 211. balloon; 212. second one-way valve; 213. first conical surface; 214. cavity; 215. diversion channel; 22. guidewire; 221. inflation / deflation channel; 23. support platform; 231. second conical surface; 232. limiting element; 3. autologous thrombus simulant; 31. fragment; 4. main blood vessel; 5. branch blood vessel. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention are clearly and completely described below through specific examples. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] A device and method for establishing a thrombected stroke simulation model for bridging and anti-bridging therapy, such as Figure 1-9 As shown, it includes: cannula 1, thrombus placement assembly 2, and autologous thrombus simulant 3: The cannula 1 has a delivery channel 11 extending along its length, and the delivery channel 11 has a distal opening 111 for insertion into a blood vessel; The bolt placement assembly 2 is movably disposed in the conveying channel 11. The bolt placement assembly 2 includes a guide wire 22, a support platform 23 and a positioning cap 21. The positioning cap 21 is disposed at the distal end of the guide wire 22, and the support platform 23 is disposed on the guide wire 22 and spaced axially from the positioning cap 21. The autologous thrombus simulator 3 is fitted onto the guidewire 22 and located between the positioning cap 21 and the support platform 23. The autologous thrombus simulator 3 is composed of autologous blood coagulation and can be dissolved into small fragments 31 in the blood vessel by thrombolytic drugs. The positioning cap 21 has an inflatable anchoring component on its outer periphery. When the anchoring component is inflated, it can abut against the inner wall of the target main blood vessel 4 to restrict the axial movement of the thrombectomy assembly 2. A first one-way valve 114 is provided in the delivery channel 11 near the distal opening 111. The first one-way valve 114 allows fluid to flow unidirectionally from the delivery channel 11 into the blood vessel. A second one-way valve 212 is provided at the distal end of the positioning cap 21. The second one-way valve 212 allows fluid to flow unidirectionally from the outside of the positioning cap 21 into the area between the positioning cap 21 and the support platform 23.

[0024] The cannula 1 is preferably made of a flexible and biocompatible medical polymer, such as polyurethane or fluorinated ethylene propylene copolymer, with an outer diameter of approximately 1-2 Fr, or 0.33mm-0.67mm, to accommodate the cerebral blood vessel size of experimental animals such as mice. The guidewire 22 can be made of nickel-titanium alloy or stainless steel, with a diameter of approximately 0.25mm, which combines good pushability and flexibility. The positioning cap 21 and the support platform 23 can be made of a medical polymer with moderate rigidity, such as PEEK. Alternatively, the support platform 23 can also be made of an elastic material such as silicone, which expands the vessel wall outward during movement to the target vessel to prevent the autologous thrombus simulator 3 from dislodging into the vessel along the path of travel during the push.

[0025] The autologous thrombus simulator 3 is preferably prepared by collecting whole blood from experimental animals and inducing coagulation in vitro. Its diameter and length can be adjusted according to experimental needs to simulate clinical thrombi of different volumes. The anchoring component is preferably a compliant medical silicone balloon 211, whose outer contour is flush with the positioning cap 21 in the deflated state to reduce delivery resistance; when inflated, its diameter can reach 1.5 to 2 times the inner diameter of the target blood vessel, thereby providing uniform and reliable radial support force in the blood vessel to achieve stable anchoring. At the same time, the pressure is controllable, aiming to reduce damage to the vascular endothelium.

[0026] The first one-way valve 114 is preferably a duckbill valve made of elastic silicone material or a valve with a cross-shaped slit. It is fixedly installed in the delivery channel 11, about 2-5 mm from the distal opening 111. Its function is to effectively prevent arterial blood from flowing back out through the cannula 1, thus maintaining the realism of hemodynamics during the simulation and avoiding the risks of blood loss and air embolism. The second one-way valve 212 can be a miniature duckbill valve structure, which is embedded in the opening on the distal end of the positioning cap 21. It allows circulating blood from the venous route, which can carry thrombolytic drugs administered intravenously, to flow unidirectionally into the area between the positioning cap 21 and the support platform 23. This accurately simulates the pharmacokinetic process of thrombolytic drugs reaching the local thrombus through systemic circulation, which is the key to the high degree of simulation achieved by this device.

[0027] In some embodiments of this application, such as Figure 1-9As shown, the delivery channel 11 also has a proximal opening located outside the body. The proximal opening includes a first opening 112 and a second opening 113. The delivery channel 11 includes a first branch channel and a second branch channel that lead from the distal opening 111 to the first opening 112 and the second opening 113 respectively, so that the cannula 1 is Y-shaped. In use, the thrombectomy assembly 2 is at least partially slidably disposed in the first branch channel and can be delivered into the blood vessel or withdrawn outside the body via the first branch channel.

[0028] In this embodiment, the cannula 1 has a Y-shaped bifurcated structure: the first branch channel communicates with the first opening 112 and is specifically used for the insertion, delivery, and withdrawal of the thrombectomy assembly 2, ensuring the independence and precision of the assembly's movement trajectory. The second branch channel communicates with the second opening 113, forming an independent perfusion channel. After the thrombectomy assembly 2 is in place, this channel can be used to infuse drugs or contrast agents without affecting the state of the thrombectomy assembly 2. The confluence of the two branch channels is outside the patient's body. In some embodiments, each branch channel has a one-way valve structure facing the main channel to prevent drugs injected during reverse bridging operations from flowing out of the first opening 112. The inner diameter of the first branch channel is slightly larger than the maximum outer diameter of the thrombectomy assembly 2, specifically 0.4-0.5 mm, to ensure smooth sliding of the assembly while reducing blood leakage through the channel. The Y-shaped dual-channel design achieves functional isolation, enabling seamless connection and switching between the bridging treatment of mechanical thrombectomy after intravenous thrombolysis and the reverse bridging treatment of intra-arterial rescue therapy after intravenous thrombolysis on the same model, greatly improving the efficiency of experimental operations and the value of scientific research.

[0029] In some embodiments of this application, such as Figure 1-9 As shown, the thrombectomy assembly 2 is movable between a first position and a second position; when in the first position, the thrombectomy assembly 2 is housed within the delivery channel 11 of the cannula 1; when in the second position, the thrombectomy assembly 2 is at least partially located within the blood vessel, and the positioning cap 21 and the support platform 23 are respectively located on opposite sides of the entrance of a target branch blood vessel 5, so that the autologous thrombus simulant 3 dissolves and enters the target branch blood vessel 5 under the drive of blood flow passing through the positioning cap 21.

[0030] In the first position, the entire thrombectomy assembly 2 is housed within the cannula 1, ensuring the safety of the device during percutaneous puncture and intravascular delivery, and preventing vascular damage that may be caused by premature deployment of the components. When moved to the second position, the thrombectomy assembly 2 is precisely deployed within the blood vessel. At this point, the support platform 23 should be located upstream of the inlet of the target branch vessel 5, while the positioning cap 21 is downstream. The axial distance between them can be set according to the diameter of the target branch vessel 5, resulting in various models based on the distance between the support platform 23 and the positioning cap 21. The space between them is used to accommodate the autologous thrombus simulator 3 and allows blood flow. This positional relationship ensures that the thrombus simulator is directly opposite the inlet of the branch vessel 5. When thrombolytic therapy is simulated and the thrombus fragments, the unidirectional blood flow from the positioning cap 21 side can most effectively flush the thrombus fragments into the target branch vessel 5, thereby accurately simulating the pathological process of distal embolism caused by embolus detachment, or other types of embolism.

[0031] In some embodiments of this application, such as Figure 1-9 As shown, the anchoring component is a balloon 211 surrounding the positioning cap 21; an inflation / deflation channel 221 is formed within the guidewire 22, one end of which communicates with the interior of the balloon 211, and the other end extends to the proximal end of the guidewire 22 for connection to an inflation / deflation device. Using the balloon 211 as the anchoring component is a preferred solution for achieving reversible and minimally invasive fixation. The balloon 211 is positioned around the proximal or middle portion of the positioning cap 21 and is sealed to it using medical adhesive or a heat fusion process. In some embodiments, the inflation / deflation channel 221 can be formed inside the guidewire 22 using precision machining techniques, such as laser engraving, or by nesting micro-lumens, with an inner diameter of not less than 0.05 mm. The distal end of the channel communicates with the lumen of balloon 211, while the proximal end extends to the handle of guidewire 22 and connects to an inflation / deflation device such as a micro-injector or pressure pump. A small amount of saline or gas is injected into balloon 211 through this integrated channel to inflate it, providing a radially uniform and controllable anchoring force. The compliance of balloon 211 allows it to adapt to vessels of different diameters. After deflation, balloon 211 rapidly retracts, releasing the anchoring force, thus achieving rapid switching of the anchoring state. The entire procedure requires no additional catheter, greatly simplifying the system and operational steps.

[0032] In some embodiments of this application, such as Figure 1-9 As shown, the positioning cap 21 and the support platform 23 have a first conical surface 213 and a second conical surface 231 facing the proximal direction, respectively; along the axial direction of the guidewire 22, the minimum outer diameter of the first conical surface 213 and the second conical surface 231 is the same as the outer diameter of the guidewire 22, so that during the process of withdrawing the thrombectomy assembly 2 from the blood vessel to the delivery channel 11, it interacts with the first one-way valve 114 in sequence and opens it.

[0033] The first conical surface 213 proximal to the positioning cap 21 and the second conical surface 231 proximal to the support platform 23 are an ingenious design feature of this device. The cone angles of both are preferably set between 30 and 60 degrees to achieve a balance between providing good guidance and controlling the resistance to passage. The minimum outer diameter of their conical portions is consistent with the outer diameter of the guidewire 22, forming a smooth transition. When simulating mechanical thrombectomy and needing to withdraw the thrombectomy assembly 2, the second conical surface 231 of the support platform 23 will first contact and gradually open the valve disc of the normally closed first one-way valve 114. This streamlined conical surface design smoothly expands the valve orifice, effectively preventing the distal end of the thrombectomy assembly 2 (which may have irregularly shaped residual thrombus simulation material attached) from directly impacting or hooking the valve. This ensures that the entire assembly can be smoothly and reliably withdrawn into the cannula 1, while protecting the structural integrity of the first one-way valve 114, thus improving the safety and lifespan of the device.

[0034] In some embodiments of this application, such as Figure 1-9 As shown, the thrombus placement assembly 2 also includes at least one limiting member 232 located between the positioning cap 21 and the support platform 23. A gap is formed on the limiting member 232, which restricts the passage of the intact autologous thrombus simulant 3 while allowing the passage of the dissolved autologous thrombus simulant 3. The limiting member 232 may be made of fine nickel-titanium wire or medical polymer filaments. In one embodiment, the limiting member 232 is 3 to 4 flexible ribs extending radially, with a gap width between the ribs of approximately 0.1-0.3 mm. In another embodiment, the limiting member 232 is a micro-mesh or grid-like structure with similarly sized openings surrounding the guidewire 22. The limiting member 232 is fixed to the guidewire 22 by a micro-metal collar or by spot welding with medical adhesive. Its working principle is that, in the initial state, its gap allows blood flow but restricts the axial movement of the intact autologous thrombus simulant 3. During thrombolysis, when the thrombus is partially dissolved and fragmented into pieces 31 smaller than the gap size by the drug, these pieces 31 can pass through the limiting member 232. This precisely simulates the process of a real thrombus being gradually disintegrated under the action of thrombolytic drugs, and can control the size of the embolic fragments entering the downstream branch vessel 5, making the simulation of the entire pathophysiological process more realistic and controllable.

[0035] In some embodiments of this application, such as Figure 1-9As shown, the limiting member 232 is a plurality of ribs extending radially; or, a mesh or grid structure surrounding the guide wire 22. The first one-way valve 114 is selected from one of a valve valve, a duckbill valve, or a slit valve made of elastic material; the second one-way valve 212 is integrated on the outer side of the positioning cap 21, the outer side of the positioning cap 21 is a convex surface facing the blood vessel, a cavity 214 is provided between the first conical surface 213 and the outer side, the cavity 214 is in one-way communication with the second one-way valve 212; and a flow channel 215 is provided between the cavity 214 and the first conical surface 213 to allow blood flow in the contralateral vein to pass through the second one-way valve 212, enter the cavity 214, and move towards the autologous thrombus simulator 3 after passing through the flow channel 215.

[0036] The second one-way valve 212 is integrated into the outer surface of the positioning cap 21, which is designed as a hemispherical or streamlined convex surface to reduce disturbance to blood flow. The positioning cap 21 has an internal cavity 214, which is connected to the proximal end of the positioning cap 21 via one or more thin flow channels 215. The flow channels 215 are oblique or straight holes with a diameter not exceeding 0.1 mm. The second one-way valve 212 serves as the sole inlet to the cavity 214, allowing unidirectional fluid injection. Blood from the vein enters the cavity 214 through the second one-way valve 212 and is then concentrated and sprayed onto the surface of the thrombus simulator through the flow channels 215. This not only efficiently utilizes thrombolytic drugs but also simulates the perfusion of the embolic site through collateral blood flow via the Willis ring in clinical conditions, significantly enhancing the simulation efficiency of treatment and the realism of the pathological process.

[0037] In addition, scale markings are provided on the outer wall of the cannula 1. Before puncture, the operator first determines the distance from the puncture point to the target position in the blood vessel through angiography or in vitro imaging. Then, the distal end of the cannula 1, which contains the thrombectomy assembly 2, is inserted from the puncture point to the target position. The insertion depth can be confirmed by the scale markings on the outer wall of the cannula 1. After the cannula 1 is inserted to the target position, the thrombectomy assembly 2, which contains the autologous thrombus simulator 3, is extended from the cannula 1, so that the simulator is positioned between the positioning cap 21 and the support platform 23, opposite to the branch blood vessel 5. Then, by inflating the inflation / deflation channel 221, the positioning cap 21 is positioned under the action of the inflated circular balloon 211.

[0038] The graduation markings are formed on the outer wall of cannula 1 using biocompatible, sterile-resistant ink through printing or laser engraving. The graduation lines are typically spaced 1 mm apart and are numbered starting from the distal end of cannula 1. Before use, the operator can pre-measure the distance from the puncture point to the target location within the target blood vessel using imaging techniques such as angiography. When inserting cannula 1, it can be pushed to the predetermined precise depth under fluoroscopic or direct visualization, based on these graduation markings. This design greatly reduces reliance on the operator's personal experience, provides an objective and repeatable depth reference for model construction, and significantly improves the standardization of model construction and the comparability of results between different batches of experiments. This is of great significance for ensuring the consistency and reliability of scientific research.

[0039] The method for establishing a device-based simulation model includes the following steps: S1. Constructing a vascular embolism model: The embolization assembly 2, carrying the autologous thrombus simulator 3, is delivered into the target main blood vessel 4 through the delivery channel 11 of the cannula 1, so that the positioning cap 21 and the support platform 23 are located on opposite sides of the entrance of the target branch blood vessel 5, and the autologous thrombus simulator 3 is located at the entrance or proximal end; then the anchoring component is inflated to fix the embolization assembly 2 in the blood vessel, simulating the vascular embolism state; this step, through integrated instrument operation, quickly creates an embolism model in which the position, size and stability can be precisely controlled, providing a standardized starting point for subsequent intervention studies.

[0040] S2. Simulated intravenous drug intervention: With the thrombectomy assembly 2 fixed in the blood vessel, thrombolytic drugs are administered via the intravenous route; the blood flow carries the thrombolytic drugs through the second one-way valve 212 into the area between the positioning cap 21 and the support platform 23, where they come into contact with the autologous thrombus simulator 3. After partially dissolving and fragmenting the simulator, the simulator fragments 31 are flushed into the target branch blood vessel 5 to simulate intravenous thrombolysis treatment; this step highly simulates the complete pharmacokinetic pathway of clinical intravenous thrombolysis and the phenomenon of embolism after thrombolysis.

[0041] S3, Simulated mechanical thrombectomy intervention: The thrombectomy component 2, together with the residual thrombus simulation material on it, is withdrawn from the body through the delivery channel 11 to simulate the mechanical thrombectomy operation; this operation simulates the core steps of removing thrombi in mechanical thrombectomy and avoids the risk of complications during the retrieval process by utilizing the structure of the device itself.

[0042] S4. Simulated Local Drug Re-intervention: After the thrombectomy assembly 2 is withdrawn, the drug is infused into the target branch vessel 5 through the delivery channel 11 of the cannula 1 and the first one-way valve 114, simulating local intra-arterial thrombolysis. This step simulates local, high-concentration intra-arterial drug delivery to the infarcted area or residual emboli, providing a key means for studying reverse bridging therapy or rescue therapy strategies.

[0043] In step S1, the delivery of the thrombectomy assembly 2 specifically includes: placing the thrombectomy assembly 2 in the first branch channel of the cannula 1 and inserting the distal end of the cannula 1 into the blood vessel; pushing the guidewire 22 so that the positioning cap 21, the support platform 23 and the autologous thrombus simulator 3 between them pass the entrance of the target branch blood vessel 5, and continuing to push the guidewire 22 until the support platform 23 moves to the proximal side of the entrance.

[0044] In step S2, after the thrombolytic drug is administered intravenously, the thrombolytic drug can enter the arterial system via the systemic circulation. The blood flow propels the drug through the contralateral blood vessel, the Willis ring, or collateral circulation to the location of the second one-way valve 212.

[0045] In step S3, before removing the bolt assembly 2, the anchoring component is first emptied to release the fixation.

[0046] In step S3, when the bolt assembly 2 is withdrawn, the first conical surface 213 of the positioning cap 21 facing the near end and / or the second conical surface 231 of the support platform 23 facing the far end pass through and push open the first one-way valve 114, so that the bolt assembly 2 can be smoothly withdrawn into the delivery channel 11.

[0047] In step S4, the drug is infused through the second branch channel of cannula 1.

[0048] In step S2, the blood flow entering through the second one-way valve 212 pushes the dissolved and fragmented thrombus simulant fragments into the target branch vessel 5.

[0049] To keep the drawings concise, only the parts relevant to this application are shown schematically in each drawing, and they do not represent the actual structure of the product. In addition, to make the drawings concise and easy to understand, in some drawings, only one of the components with the same structure or function is shown schematically, or only one of them is labeled.

[0050] It should be understood that although this specification describes various embodiments, not every embodiment contains only one independent technical solution. This way of describing the specification is only for clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

[0051] The detailed descriptions listed above are merely specific descriptions of feasible embodiments of this application and are not intended to limit the scope of protection of this application. All equivalent implementations or modifications made without departing from the spirit of the art of this application, such as combinations, divisions or repetitions of features, should be included within the scope of protection of this application.

Claims

1. A device for establishing a thrombected stroke simulation model for bridging and anti-bridging therapy, characterized in that, include: A cannula having a delivery channel extending along its length, the delivery channel having a distal opening for insertion into a blood vessel; A bolus placement assembly is movably disposed in the delivery channel. The bolus placement assembly includes a guide wire, a support platform, and a positioning cap. The positioning cap is disposed at the distal end of the guide wire, and the support platform is disposed on the guide wire and spaced axially from the positioning cap. The autologous thrombus simulator is fitted onto the guidewire and positioned between the positioning cap and the support platform; The positioning cap is provided with an inflatable anchoring component on its outer periphery. When the anchoring component is in an inflatable state, it can abut against the inner wall of the target main blood vessel to restrict the axial movement of the thrombectomy assembly. A first one-way valve is provided in the delivery channel, which allows fluid to flow unidirectionally from the delivery channel into the blood vessel. A second one-way valve is provided at the far end of the positioning cap, which allows fluid to flow unidirectionally from the outside of the positioning cap to the area between the positioning cap and the support platform. The positioning cap and the support platform each have a first tapered surface and a second tapered surface facing the proximal direction, respectively; along the axial direction of the guidewire, the minimum outer diameter of the first tapered surface and the second tapered surface is the same as the outer diameter of the guidewire, so as to interact with and open the first one-way valve in sequence during the process of withdrawing the thrombectomy assembly from the blood vessel to the delivery channel.

2. The simulation model building apparatus according to claim 1, characterized in that, The delivery channel also has a proximal opening located outside the body, the proximal opening including a first opening and a second opening, the delivery channel including a first branch channel and a second branch channel leading from the distal opening to the first opening and the second opening respectively, such that the cannula is Y-shaped; in use, the thrombectomy assembly is at least partially slidably disposed within the first branch channel.

3. The simulation model building device according to claim 2, characterized in that: The thrombus assembly is movable between a first position and a second position; When in the first position, the bolus assembly is received within the delivery channel of the sleeve; When in the second position, the thrombus placement assembly is at least partially located within the blood vessel, and the positioning cap and the support platform are located on opposite sides of the entrance to a target branch blood vessel, so that the autologous thrombus mimicry dissolves and enters the target branch blood vessel driven by the blood flow passing through the positioning cap.

4. The simulation model building apparatus according to claim 1, characterized in that, The anchoring component is a balloon surrounding the positioning cap; an inflation / deflation channel is formed inside the guidewire, one end of which communicates with the interior of the balloon, and the other end extends to the proximal end of the guidewire for connection to an inflation / deflation device.

5. The simulation model building apparatus according to claim 1, characterized in that, The thrombus placement assembly further includes at least one limiting member located between the positioning cap and the support platform. A gap is formed on the limiting member, which can restrict the passage of the intact autologous thrombus mimic while allowing the passage of the dissolved autologous thrombus mimic.

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