In vitro simulated blood vessel simulation device and embolization agent performance evaluation device

Abstract

This invention provides an in vitro simulated blood vessel device and an embolic agent performance evaluation device. The in vitro simulated blood vessel device includes an interventional device port, a basic vascular access, a biomimetic arterial module, a pressure measuring module, a first resistance valve, a pump tank, a pulse pump, and a flow meter, all connected sequentially via tubing. The pressure measuring module enables real-time monitoring of the fluid pressure in the tubing, thereby monitoring the stability of the embolization. The transparent biomimetic blood vessel tubing highly replicates the vascular structure, providing a realistic vascular simulation environment and facilitating long-term observation of the embolic agent's status and the patency of the embolic area. This device can be widely used for in vitro performance testing and evaluation of embolic agents and other implantable medical devices.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology and relates to an in vitro simulated blood vessel simulation device and an embolization agent performance evaluation device. Background Technology

[0002] Interventional embolization has been widely used in the treatment of internal bleeding, tumor therapy, and surgical resection. This technique involves delivering an embolic agent through a catheter to block blood flow in a target vessel, with the entire process guided by real-time imaging. The key to interventional embolization lies in the effectiveness of the embolic agent and the accurate and appropriate delivery of the agent to the target vessel during the interventional procedure.

[0003] Interventional embolization therapy aims to achieve various therapeutic goals, including hemostasis and tumor-feeding vessel embolization, depending on the specific lesion. Factors such as the rapid solidification of the embolic agent at the embolization site, its stability under blood pressure, and its degradation within the expected timeframe all significantly impact the embolization effect. Therefore, high-performance embolic agents are crucial for ensuring the effectiveness of interventional embolization therapy. During embolic agent development, repeated experimental evaluations and verifications of the embolic performance, such as solidification properties and embolic stability, are necessary. Existing extracorporeal simulation devices for vascular interventional embolization are designed to assist physicians in mastering embolic agent injection techniques or interventional procedures, lacking components for monitoring and evaluating embolic agent performance. Furthermore, some extracorporeal simulation devices have low fidelity to blood vessels, failing to provide a realistic simulation environment and hindering accurate evaluation of embolic agent performance. Therefore, no integrated device specifically designed for evaluating embolic agent performance has yet been publicly disclosed. Utility Model Content

[0004] In view of the above-mentioned defects of the prior art, the present invention provides an in vitro simulated blood vessel device that can highly restore the blood vessel structure and realize real-time monitoring of changes in blood pressure in blood vessels and the embolization effect of embolic agents in blood vessels.

[0005] This application provides an in vitro simulated blood vessel device, comprising, via tubing, a device intervention port, a basic vascular access, a biomimetic arterial module, a pressure measuring module, a first resistance valve, a pump tank, a pulse pump, and a flow meter, connected in sequence.

[0006] The device intervention port includes a catheter intervention port; the basic vascular access includes a basic vascular structure for simulating the catheter intervention body; the bionic arterial vascular module includes multiple vascular branches for simulating the vascular structure at the embolization site; and the pressure measurement module includes a pipeline hydraulic monitoring device.

[0007] The pipeline is a closed pipeline with its ends connected.

[0008] In some embodiments, the pressure testing module further includes a water tank and multiple pressure testing ports. The water tank is provided with a fluid inlet and a fluid outlet, and the fluid inlet and the fluid outlet are respectively connected to the pipeline.

[0009] In some embodiments, the plurality of pressure measuring ports are in fluid communication with the water tank, and the plurality of pressure measuring ports are provided with a second resistance valve.

[0010] In some embodiments, the pressure measuring module is further provided with at least one liquid collection port.

[0011] In some embodiments, the pipeline is further provided with a temperature control device.

[0012] In some embodiments, the pulsating pump is a gear pump with a flow rate range of 20-40 mL / s.

[0013] In some embodiments, the plurality of vascular branches include primary vascular branches, secondary vascular branches, and tertiary vascular branches, wherein the primary vascular branch is the inlet of the tubing, the secondary vascular branch is the outlet of the tubing, and the tertiary vascular branch is an embolizable area.

[0014] In some embodiments, the conduit is a transparent silicone conduit with an inner diameter of 3-5 mm and an outer diameter of 7-10 mm.

[0015] In some embodiments, the pump tank has an upper opening; and / or the tank is a sealed transparent box.

[0016] This application also provides an embolic agent performance evaluation device, including the in vitro simulated blood vessel device and the embolic agent injection assembly as described above. In some embodiments, the device further includes a hydraulic sensing device installed downstream of the embolic agent embolization site for monitoring the embolization status of the embolic agent.

[0017] Beneficial effects:

[0018] This application provides an in vitro simulated blood vessel device equipped with a real-time pressure measurement module, which can monitor the liquid pressure in the pipeline in real time and perform long-term real-time monitoring of the embolization performance of the embolic agent. Moreover, it can highly restore the blood vessel structure and provide a realistic blood vessel simulation environment, which can be widely used for in vitro performance testing and evaluation of embolic agents. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of the in vitro simulated blood vessel device provided in the embodiments of this application;

[0020] Figure 2 The diagram shows the structure of the bionic arterial blood vessel module of the in vitro simulated blood vessel device according to an embodiment of this application, which is a hepatic artery blood vessel model.

[0021] 10. Tubing, 1. Instrument intervention port, 2. Basic vascular access, 3. Bionic arterial vascular module, 4. Pressure measurement module, 5. First resistance valve, 6. Pump tank, 7. Pulsating pump, 8. Flow meter, 11. Catheter intervention port, 41. Water tank, 42. Pressure measurement port, 411. Fluid inlet, 412. Fluid outlet, 43. Secondary resistance valve, 31. Primary vascular branch, 32. Secondary vascular branch, 33. Tertiary vascular branch, 34. Embolization site, 35. Pressure sensor, 9. Temperature control device. Detailed Implementation

[0022] The embodiments of this application are described in detail below with reference to the accompanying drawings. Examples of the embodiments are shown in the drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain this application, and should not be construed as limiting this application.

[0023] The terms "first," "second," "primary," "secondary," etc., used in the specification and claims of this application are used to distinguish similar objects and not to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of this application can be implemented in orders other than those illustrated or described herein, and the objects distinguished by "first," "second," etc., are generally of the same class and the number of objects is not limited; for example, a first object can be one or more. Furthermore, in the specification and claims, "and / or" indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0024] In the description of this application, "multiple" means two or more, and "at least one" indicates that there may be one, two, three or more.

[0025] In the description of this application, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0026] In the description of this application, "in sequence" means that, in the working state, the apparatus or its parts are installed in the listed order. In some embodiments, it means that the parts are connected in sequence via pipelines and are in fluid communication, and the installation is such that each component can perform its function.

[0027] refer to Figure 1 and Figure 2 This application provides an in vitro simulated blood vessel simulation device, which includes an instrument intervention port 1, a basic blood vessel access 2, a bionic arterial blood vessel module 3, a pressure measuring module 4, a first resistance valve 5, a pump tank 6, a pulse pump 7, and a flow meter 8 connected in sequence via a pipeline 10.

[0028] Among them, the device intervention port 1 includes the catheter intervention port 11, through which the injection catheter can enter the simulated vascular access when the embolization agent is injected.

[0029] Basic vascular access 2 includes basic vascular structures used to simulate catheter-based interventions within the body;

[0030] The biomimetic arterial module 3 includes multiple vascular branches for simulating the vascular structure at the embolization site, and for simulating the embolization site of the embolizing agent;

[0031] Pressure measurement module 4 includes a pipeline hydraulic monitoring device for measuring and detecting pressure changes in the pipeline;

[0032] The tubing 10 is a closed loop, meaning it starts at one end of the device intervention port 1, flows sequentially through the basic vascular access 2, the bionic arterial module 3, the pressure measuring module 4, the first resistance valve 5, the pump tank 6, the pulse pump 7, and the flow meter 8, before returning to the other end of the device intervention port 1, forming a closed loop. The pressure measuring module 4 detects the pressure within the tank 41, thereby monitoring the pressure changes within the tank 41 when embolization occurs in the bionic arterial module 3, and evaluating the embolic effect of the embolizing agent.

[0033] In addition to the pipeline hydraulic monitoring device, the pressure measuring module 4 also includes a water tank 41 and multiple pressure measuring ports 42. The water tank is equipped with a fluid inlet 411 and a fluid outlet 412, which are respectively connected to the pipeline 10. The pipeline hydraulic monitoring device can measure the liquid pressure through the multiple pressure measuring ports 42.

[0034] Multiple pressure measuring ports 42 are in fluid communication with the water tank 41, and each pressure measuring port 42 is equipped with a second resistance valve 43. The pressure measuring module 4 is also provided with at least one liquid collection port. In some embodiments, the water tank 41 is a sealed tank.

[0035] The pump tank 6 has an upper opening for storing and adding water. The pump tank 6 is located at the input end of the pulse pump 7. The pulse pump 7 is a gear pump that provides power and flow rate to the fluid in the pipeline 10. In some embodiments, the output flow rate of the gear pump is in the range of 20-40 mL / s. The output end of the pulse pump 7 is connected to the input end of the basic vascular access 2 via a flow meter 8 to control the fluid flow rate in the vascular access.

[0036] Multiple vascular branches include a primary vascular branch 31, a secondary vascular branch 32, and a tertiary vascular branch 33. The primary vascular branch 31 is the inlet of the tubing, through which fluid flows into the bionic arterial module 3. The secondary vascular branch 32 is the outlet of the tubing, flowing out of the bionic arterial module 3 and into the conduit 10, ultimately flowing towards the pressure measuring module 4. In some embodiments, the tertiary vascular branch 33 is an embolizable region, into which an embolic agent can be injected, causing a change in the fluid pressure within the conduit 10. See also [link to related embodiments]. Figure 2 The biomimetic arterial module 3 is a biomimetic hepatic artery model. The primary vascular branch 31 is the common hepatic artery, and the tertiary vascular branches 33 include the left branch 331 and the right branch 332 of the hepatic artery. In some embodiments, other hepatic artery branch structures or capillary networks may also be included.

[0037] The first resistance valve 5 and the second resistance valve 43 can provide fluid resistance that simulates human blood vessel resistance, providing a more realistic vascular access simulation environment.

[0038] The conduit 10 can be a transparent silicone conduit or any known biomimetic vascular material. In some embodiments, the conduit 10 has an inner diameter of 3-5 mm and an outer diameter of 7-10 mm.

[0039] In some embodiments, a temperature control device 9 is also provided on the pipeline 10. This temperature control device 9 is used to monitor and control the temperature of the liquid in the pipeline to a preset range, such as heating it to 36-37°C, providing a working environment closer to human body temperature. In some embodiments, the temperature control device 9 includes a temperature sensor, a heating element, and an automatic temperature adjustment device. When the temperature sensor detects that the temperature is outside the preset range, it triggers the automatic temperature adjustment device to provide feedback to the heating element to turn on or off, thereby achieving temperature control of the entire device. The temperature control accuracy of the temperature control device 9 is ±0.5°C.

[0040] In some embodiments, the fluid used in this experiment is not particularly limited. For example, known biomimetic blood fluids such as phosphate buffer, water-glycerol mixture, or heparinized anticoagulated blood can be used for the experiment.

[0041] This application also provides an embolic agent performance evaluation device, including the in vitro simulated blood vessel device and the embolic agent injection component provided in the previous embodiment. The embolic agent injection component injects the embolic agent into the biomimetic artery module 3 in the in vitro simulated blood vessel device for embolization. The embolic effect of the embolic agent is evaluated by measuring the pressure change of the tubing 10 before and after embolization using the pressure measuring module 4. Furthermore, during subsequent observation, the embolic area can be stained and angiographically contrasted using an angiography catheter to observe whether the staining agent flows out of the embolized blood vessel from outside the tubing, thereby determining the patency of the embolized blood vessel and further evaluating the long-term embolic stability of the embolic agent within the tubing. See also... Figure 2 In some embodiments, the device also includes a detachably mounted hydraulic sensor 35, which is installed downstream of the embolization site 34 and can monitor whether the embolization agent has been successfully embolized at the embolization site 34 after injection and whether there is any leakage from the embolization site 34.

[0042] The embolization agent performance evaluation device provided in this application embodiment can be used for performance evaluation of various vascular embolization agents, such as the embolization performance evaluation of temperature-sensitive liquid tumor embolization agents; it can also be used to evaluate and test the simulated use performance of implantable interventional medical devices such as guidewires, catheters, and stents in vascular access.

[0043] When evaluating the performance of embolic agents using the device provided in this application embodiment, after the device is assembled, biomimetic blood and other fluids are added and enter the pipeline to begin circulation. The temperature control device 9 is turned on, the pressure measurement module 4 is turned on for real-time pressure detection, the pulse pump 7 is turned on and the fluid flow rate is set according to the flow meter 8. When the device temperature stabilizes, the embolic agent is injected into the embolization area of ​​the biomimetic arterial module 3, such as the preset embolization site 34 of the tertiary vascular branch 33, using the embolic agent injection component. The pressure change of the water tank 41 and the pressure downstream of the embolization site 34 are monitored simultaneously. After the injection is completed, the pressure change and embolization maintenance can be continuously monitored to evaluate the embolization strength, anti-blood flow erosion time and degradation time of different embolic agents.

[0044] The in vitro simulated blood vessel device provided in this application embodiment is equipped with a real-time pressure measurement module, which can monitor the liquid pressure in the pipeline in real time. The transparent silicone pipeline also facilitates the observation of the embolization area, thereby realizing long-term real-time monitoring of the embolization performance of the embolization agent, and can be widely used in the field of embolization agent development.

[0045] Although embodiments of this application have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the claims and their equivalents.

Claims

1. An in-vitro simulated blood vessel simulation device, characterized by, This includes, in sequence via tubing, an interventional device port, a basic vascular access, a bionic arterial module, a pressure measurement module, a first resistance valve, a pump tank, a pulse pump, and a flow meter. The device intervention port includes a catheter intervention port; the basic vascular access includes a basic vascular structure for simulating the catheter intervention body; the bionic arterial vascular module includes multiple vascular branches for simulating the vascular structure at the embolization site; and the pressure measurement module includes a pipeline hydraulic monitoring device. The pipeline is a closed pipeline with its ends connected.

2. The in-vitro simulated blood vessel simulation device of claim 1, wherein, The pressure measurement module also includes a water tank and multiple pressure measurement ports. The water tank is provided with a fluid inlet and a fluid outlet, and the fluid inlet and the fluid outlet are respectively connected to the pipeline.

3. The in-vitro simulated blood vessel simulation device of claim 2, wherein, Multiple pressure measuring ports are in fluid communication with the water tank, and each of the multiple pressure measuring ports is equipped with a second resistance valve.

4. The in-vitro simulated blood vessel simulation device of claim 1, wherein, A temperature control device is also installed on the pipeline.

5. The in-vitro simulated blood vessel simulation device of claim 1, wherein, The pulsating pump is a gear pump with a flow rate range of 20-40 mL / s.

6. The in vitro simulated blood vessel simulation device according to claim 2, characterized in that, The multiple vascular branches include primary vascular branches, secondary vascular branches, and tertiary vascular branches, wherein the primary vascular branches are the inlet of the tubing, the secondary vascular branches are the outlet of the tubing, and the tertiary vascular branches are embolizable areas.

7. The in-vitro simulated blood vessel simulation device of claim 1, wherein, The tubing is made of silicone, with an inner diameter of 3-5mm and an outer diameter of 7-10mm.

8. The in-vitro simulated blood vessel simulation device of claim 2, wherein, The pump tank has an upper opening; and / or the tank is a sealed container.

9. An embolic agent performance evaluation device, characterized by, Includes the in vitro simulated blood vessel simulation device and embolization agent injection assembly as described in any one of claims 1-8.

10. The embolic performance evaluation device of claim 9, wherein, The device also includes a hydraulic sensing device installed downstream of the embolization location to monitor the embolization status of the embolic agent.

Images