A pulsatile transparent heart model experimental platform for left atrial appendage occlusion and a preparation method and application thereof

Abstract

The application belongs to the technical field of medical devices, and provides a pulsating transparent heart model experimental platform for left atrial appendage occlusion, a preparation method and application thereof. The experimental platform comprises a transparent flexible heart simulator and a pneumatic driving device. The transparent flexible heart simulator comprises a transparent flexible heart simulator body, an intervention operation channel connected with the transparent flexible heart simulator body, and a pneumatic driving interface. The pneumatic driving device is connected with the pneumatic driving interface through a pneumatic driving pipeline, and is used for making the transparent flexible heart simulator body produce periodic pulsation deformation through periodic air supply and / or air exhaust. The transparent flexible heart simulator body is a hollow cavity, and comprises a left atrium simulation module and a left atrial appendage simulation module in communication with the left atrium simulation module. The intervention operation channel is in communication with the hollow cavity and is used for the left atrial appendage occluder delivery system to enter. The pneumatic driving interface is separately arranged from the intervention operation channel. The application can solve the problems that the existing heart model experimental platform cannot simulate the heart pulsation process, and the mutual interference between the instrument operation and the driving structure.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an experimental platform for left atrial appendage occlusion using a pulsatile transparent heart model, its preparation method, and its application. Background Technology

[0002] Left atrial appendage occlusion is an important interventional treatment for reducing the risk of thromboembolism in some patients with atrial fibrillation. This type of procedure typically requires a guidewire, catheter, and occluder delivery system to enter the heart, where positioning, deployment, retrieval, repositioning, and release are performed in the left atrial appendage opening region. Due to the significant variations in the morphology of the left atrial appendage, the choice of occluder size, release location, fit, and residual leakage risk all affect the surgical outcome. Therefore, a laboratory platform capable of visually representing the structure of the left atrial appendage and the status of the devices is necessary during preoperative planning, device training, and in vitro validation.

[0003] Most existing cardiac models are primarily for anatomical display and are typically rigid or semi-rigid static models, mainly used to demonstrate the shape and structural relationships of the heart. While these models facilitate observation, they usually cannot produce periodic deformations similar to those of a real heartbeat, and they are also insufficient to meet the needs of left atrial appendage occlusion procedures for observing instrument insertion, path adjustment, occluder deployment, and fit.

[0004] In addition, some existing cardiac models or fabrication methods have adopted methods such as using soluble material molds, casting with silicone-based materials, and removing the mold after curing to obtain flexible cardiac model structures. The focus of these technologies is usually on the fabrication route of the cardiac model or the simulation and reproduction of cardiac structures such as valves, and they have not developed a dedicated pulsatile transparent experimental platform for preoperative planning of left atrial appendage occlusion, occluder training, observation of occlusion effect, and in vitro verification.

[0005] In summary, the shortcomings and deficiencies of existing technologies are as follows: (1) Most existing heart models are static structures, which cannot simulate the heart beating process and cannot reflect the positional changes and fit of the occluder in a dynamic state.

[0006] (2) Existing cardiac models usually lack a specific design for left atrial appendage occlusion. The operating space in the left atrial appendage area is limited, which is not conducive to the entry, deployment, retrieval and observation of the occluder.

[0007] (3) Existing heart models lack transparency, flexibility and cavity connectivity, making it difficult to visually observe the deployment angle, axial position and fitting range of the occluder at the opening of the left atrial appendage.

[0008] (4) Some existing dynamic cardiac models have complex structures, or the drive interface and interventional operation channel are not separated, which can easily cause mutual interference between the air pump pipeline and the catheter, sheath or occluder delivery system.

[0009] Therefore, there is a need for a transparent, flexible, and pulsatile cardiac model experimental platform for left atrial appendage occlusion procedures, which can be used for preoperative planning, instrument operation training, observation of occluder position and fit, and in vitro validation. Summary of the Invention

[0010] To address the problems of existing cardiac model experimental platforms, such as their inability to simulate the heart's pulsation process, easy interference between instrument operation and drive structure, and limited observation and operation space in the left atrial appendage occlusion operation area, this invention provides a pulsating transparent cardiac model experimental platform for left atrial appendage occlusion and its preparation method.

[0011] This invention is achieved through the following technical solution: In a first aspect, the present invention provides an experimental platform for a pulsating transparent heart model for left atrial appendage occlusion, comprising a transparent flexible heart phantom and a pneumatic drive device. The transparent flexible heart phantom includes a transparent flexible heart phantom body, an interventional operation channel connected to the transparent flexible heart phantom body, and a pneumatic drive interface. The pneumatic drive device is used to connect to the pneumatic drive interface via a pneumatic drive pipeline and to cause the transparent flexible heart phantom body to undergo periodic pulsating deformation through periodic air supply and / or air exhaust. The transparent flexible heart phantom body is hollow, and the transparent flexible heart phantom body includes a left atrial simulation module and a left atrial appendage simulation module connected to the left atrial simulation module. The interventional operation channel is connected to the cavity and allows the left atrial appendage occluder delivery system to enter. The pneumatic drive interface is separately disposed from the interventional operation channel.

[0012] Preferably, the volume of the left atrial appendage simulation module accounts for 5% to 8% of the total volume of the transparent flexible heart phantom body.

[0013] Preferably, the pneumatic drive interface and the interventional operation channel are located at different ends, different sidewalls, or different directions of the transparent flexible heart phantom body; when the pneumatic drive device is connected to the pneumatic drive interface through the pneumatic drive pipeline, the pneumatic drive pipeline avoids the observation area of ​​the left atrial appendage simulation module and the operation path of the interventional device.

[0014] Preferably, the transparent flexible heart phantom is made of a transparent or semi-transparent elastic material.

[0015] Preferably, the left atrial appendage simulation module and the left atrial appendage simulation module are detachably connected.

[0016] Secondly, the present invention provides a method for preparing the experimental platform for left atrial appendage occlusion pulsatile transparent heart model, wherein the transparent flexible heart phantom is prepared by a water-soluble material sacrificial mold, a transparent split outer mold and a replaceable water-soluble inner core combined mold or a mold-making process.

[0017] Preferably, the transparent flexible heart phantom is prepared using a water-soluble material sacrificial mold, and the preparation method is as follows: Based on the target shape of the required transparent and flexible heart phantom, a three-dimensional model is created to obtain the mold model; Based on the mold model, a water-soluble material is used for 3D printing to obtain a sacrificial mold made of water-soluble material; A transparent elastic material is poured into the interior of a water-soluble material sacrificial mold. After pouring, the material is cured and molded to form a transparent and flexible heart phantom inside the water-soluble material sacrificial mold. The transparent flexible heart phantom with a water-soluble material sacrificial mold is immersed in water to dissolve the water-soluble material sacrificial mold, thus obtaining the transparent flexible heart phantom body.

[0018] Furthermore, the water-soluble material is polyvinyl alcohol.

[0019] Preferably, the transparent split outer mold and replaceable water-soluble inner core combined mold includes a transparent split outer mold and a replaceable water-soluble inner core, and the transparent split outer mold consists of two parts; the preparation method is as follows: Based on the target shape of the required transparent and flexible heart phantom, a three-dimensional model was created to obtain a transparent split outer model and a replaceable water-soluble inner core. A replaceable water-soluble inner core is placed in a transparent split outer mold, and a mold cavity is formed between the transparent split outer mold and the replaceable water-soluble inner core; A transparent elastic material is poured into the mold cavity, and the flow of the transparent elastic material, residual air bubbles, and the location of the replaceable water-soluble inner core are observed. After the transparent elastic material solidifies, a transparent flexible heart phantom body is formed in the mold cavity. The two parts of the transparent split outer mold are separated, and the transparent flexible heart phantom with a replaceable water-soluble inner core is taken out and soaked in water to dissolve the replaceable water-soluble inner core, thus obtaining the transparent flexible heart phantom body.

[0020] Thirdly, the present invention provides an application of the aforementioned pulsatile transparent heart model experimental platform for left atrial appendage occlusion in preoperative planning, catheter path training, occluder release training, occluder position observation, occlusion effect observation, or in vitro verification of occlusion effect in left atrial appendage occlusion. A pneumatic drive interface is connected to an air pump via a pneumatic drive pipeline. Gas is introduced into the cavity within the transparent flexible heart phantom through the air pump, causing the transparent flexible heart phantom to undergo periodic pulsatile deformation. The occluder is then delivered from the interventional operation channel to the left atrial appendage simulation module for preoperative planning, catheter path training, occluder release training, occluder position observation, occlusion effect observation, or in vitro verification of occlusion effect in left atrial appendage occlusion.

[0021] Compared with the prior art, the present invention has the following beneficial effects: The pulsating transparent heart model experimental platform for left atrial appendage occlusion described in this invention features a transparent flexible heart phantom with a pneumatic drive interface for connecting an air pump. This pneumatic drive interface is separated from the interventional procedure channel to reduce interference between the pneumatic drive tubing and the interventional instruments entering through the channel. On one hand, the transparent flexible heart phantom allows the operator to directly observe the movement of the guidewire, catheter, sheath, and occluder within the phantom, facilitating teaching demonstrations, preoperative protocol discussions, and occlusion device training. On the other hand, the pneumatic drive interface connects to a pneumatic drive device, which, through periodic air supply and exhaust, causes the transparent flexible heart phantom to undergo periodic pulsating deformation. This allows for dynamic observation of the stability, fit, and positional changes of the occluder after release, more closely resembling the dynamic environment of a real interventional procedure.

[0022] Furthermore, the simulated left atrial appendage cavity of this invention has been enlarged, which provides more operating space for the occluder to enter, deploy, retract, and fit for observation, and is beneficial for the operator to observe the relative positional relationship between the occluder and the periphery of the left atrial appendage opening.

[0023] Furthermore, the pneumatic drive interface and the interventional operation channel are located at different ends, different sidewalls, or different directions of the transparent flexible heart phantom body, and the pneumatic drive tubing avoids the observation area of ​​the left atrial appendage simulation module and the operation path of the interventional device. This can reduce the mutual interference between the pneumatic drive tubing of the air pump and the delivery system of the catheter, sheath, or occluder, and improve the stability of operation and the convenience of repeated training.

[0024] Furthermore, the left atrial appendage simulation module and the left atrium simulation module are detachably connected, and left atrial appendage simulation modules of different shapes, sizes, hardness or wall thicknesses can be connected to simulate different left atrial appendage anatomical shapes and occlusion operation difficulties.

[0025] The transparent flexible heart phantom of this invention can be prepared by using a transparent split outer mold and a replaceable water-soluble inner core in combination. The replaceable water-soluble inner core is set inside the transparent split outer mold to define the cavity of the transparent flexible heart phantom. During casting, the operator can observe the flow of transparent elastic material, residual air bubbles, and the position of the replaceable water-soluble inner core through the transparent split outer mold, thereby improving the quality of the transparent flexible heart phantom. The transparent split outer mold can be composed of two parts, left and right, and can be disassembled and reused to reduce material consumption caused by repeated printing of outer molds.

[0026] The pulsating transparent heart model experimental platform for left atrial appendage occlusion described in this invention can be used for preoperative planning, catheter pathway training, occluder release training, occluder position observation, occlusion effect observation, or in vitro verification of occlusion effect. Gas is introduced into the cavity of the transparent flexible heart phantom by an air pump, causing the transparent flexible heart phantom to produce periodic pulsating deformation. The deployment, adhesion, release, retraction, and stabilization of the occluder can be observed from the outside of the transparent flexible heart phantom. By repeatedly observing the positional changes of the occluder in the pulsating state, it can be used to determine whether the occluder stably adheres to the opening of the left atrial appendage, whether it has shifted, and whether there is any possible residual gap. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 This is a schematic cross-sectional view of a mold model designed for one embodiment of the present invention.

[0029] Figure 2 This is a schematic diagram of a PVA mold obtained according to an embodiment of the present invention.

[0030] Figure 3 This is a transparent flexible heart phantom obtained in one embodiment of the present invention.

[0031] Figure 4 This is a schematic diagram of the overall experimental platform for the pulsatile transparent heart model used for left atrial appendage occlusion according to the present invention.

[0032] Figure 5 This is a schematic diagram of a combined mold of a transparent split outer mold and a replaceable water-soluble inner core in an extended embodiment of the present invention. Detailed Implementation

[0033] The following specific examples illustrate the implementation of the present invention. 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, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0034] It should be noted that the process equipment or apparatus not specifically mentioned in the following embodiments are all conventional equipment or apparatus in the art.

[0035] It should be noted that the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or apparatus that includes a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to these processes, methods, products, or apparatuses. Furthermore, unless otherwise stated, the numbering of each method step is merely a convenient tool for identifying each method step, and not intended to limit the order of the method steps or define the scope of the invention. Changes or adjustments to their relative relationships, without substantially altering the technical content, should also be considered within the scope of the invention.

[0036] The experimental platform for left atrial appendage occlusion using a pulsating transparent heart model according to the present invention includes a transparent flexible heart phantom and a pneumatic drive device. The transparent flexible heart phantom includes a transparent flexible heart phantom body, an interventional operation channel connected to the transparent flexible heart phantom body, and a pneumatic drive interface. The pneumatic drive device is used to connect to the pneumatic drive interface through a pneumatic drive pipeline and to cause the transparent flexible heart phantom body to produce periodic pulsating deformation through periodic air supply and / or air exhaust. The transparent flexible heart phantom body has a cavity inside. The transparent flexible heart phantom body includes a left atrial simulation module and a left atrial appendage simulation module connected to the left atrial simulation module. The interventional operation channel is connected to the cavity and allows the left atrial appendage occluder delivery system to enter. The pneumatic drive interface is separately set from the interventional operation channel.

[0037] The transparent flexible heart phantom is made of transparent or semi-transparent elastic material, allowing the operator to directly observe the movement of the guidewire, catheter, sheath, and occluder inside the transparent flexible heart phantom.

[0038] In some embodiments of the present invention, the transparent flexible heart phantom is made of a transparent elastic material, preferably silicone. Depending on the simulation requirements, the material hardness and local wall thickness can be adjusted to give different regions different support or deformation capabilities.

[0039] The left atrial appendage simulation module can be locally enlarged, with the left atrial appendage opening area widened, wall thickness adjusted, or observation area enhanced based on the actual anatomical morphology, to form a target operating area that facilitates the entry, deployment, retrieval, and observation of the occluder. In the model design reference, the actual volume of the left atrial appendage is usually significantly smaller than the overall volume of the heart; in some embodiments of this invention, the enlarged left atrial appendage simulation chamber module accounts for 5% to 8% of the total internal cavity volume of the transparent flexible heart phantom body. When this proportion is less than 5%, there is insufficient space for the occluder deployment, retrieval, and observation; when this proportion is greater than 8%, the left atrial appendage area is excessively enlarged relative to the left atrium simulation module, which may reduce the model's simulation realism of the left atrial appendage occlusion operation path. Through this design, the operator can more clearly observe the fit of the occluder disc or umbrella-shaped structure with the periphery of the left atrial appendage opening, the axial position of the occluder, and whether displacement occurs after release.

[0040] In one extended embodiment, the left atrial appendage simulation module can also be designed as a detachable connection structure: a connection port is provided on the transparent left atrial appendage simulation module, and the left atrial appendage simulation module is connected to the connection port by means of sleeve, plug, snap, or sealing ring. Different left atrial appendage simulation modules can have different shapes, sizes, rigidities, or wall thicknesses to simulate different left atrial appendage anatomical shapes and occlusion operation difficulties.

[0041] In some embodiments of the present invention, the flexible heart phantom body may further include pulmonary vein inlet, mitral valve region, atrial septal puncture inlet, or other cardiac chamber structures related to the left atrial appendage occlusion intervention path, as needed for training and validation.

[0042] The interventional channel communicates with the internal cavity of the transparent flexible heart phantom body, allowing guidewires, catheters, sheaths, or left atrial appendage occluder delivery systems to enter the transparent flexible heart phantom body. The interventional channel can be located at one end or on the side wall of the transparent flexible heart phantom body and can be equipped with elastic sealing plugs, sealing connectors, or replaceable connectors to reduce air or fluid leakage during device insertion and removal, and to improve the convenience of repeated training.

[0043] In some embodiments of the present invention, the pneumatic drive interface and the interventional operation channel are set separately, and the two are located at different ends, different sidewalls or different directions of the transparent flexible heart phantom body, so that the pneumatic drive line of the air pump does not obstruct the observation field of the left atrial appendage area, nor does it hinder the operation of the catheter, sheath and occluder delivery system, thereby reducing the mutual interference between the drive line and the interventional device.

[0044] In some embodiments of the present invention, the pneumatic drive device can be a pneumatic pump with adjustable frequency and / or adjustable pressure, or a pump body device capable of periodically supplying and venting air. When the pneumatic drive device is in operation, gas enters or exits the transparent flexible heart phantom body through the pneumatic drive interface, causing the phantom wall to periodically expand and contract, thereby simulating the heartbeat. To maintain the repeatability of the pulsating deformation, the interventional operation channel can be equipped with an elastic sealing plug, a sealing joint, or a replaceable connector, and the pneumatic drive interface can be equipped with a one-way valve, a pressure relief valve, or a pressure regulator.

[0045] The present invention discloses a method for preparing a pulsatile transparent heart model experimental platform for left atrial appendage occlusion, wherein the transparent flexible heart phantom is prepared by means of a water-soluble material sacrificial mold, a transparent split outer mold combined with a replaceable water-soluble inner core mold, a detachable mold, a three-dimensional printing mold, or a mold-making process.

[0046] In one alternative implementation, a mold containing a left atrial appendage simulation module, interventional operation channel and pneumatic drive interface can be designed based on a digital model first. A sacrificial mold is printed using a water-soluble material, and then a transparent elastic material is poured in. After the material has solidified, the water-soluble mold is removed to obtain a transparent flexible heart phantom.

[0047] The specific methods for preparing this transparent, flexible heart phantom include: Based on the target shape of the required transparent and flexible heart phantom, a three-dimensional model is created to obtain the mold model; Based on the mold model, a water-soluble material is used for 3D printing to obtain the mold. Figure 1 and Figure 2 ); A transparent elastic material is poured into the mold. After pouring, it is cured and molded to form a transparent and flexible heart-shaped prototype inside the mold. The transparent flexible heart phantom with the mold was immersed in water to dissolve the mold, thus obtaining the transparent flexible heart phantom body. Figure 3 ).

[0048] This preparation method is only one specific way to realize the above-mentioned experimental platform and is not the only limitation of this invention.

[0049] In one extended embodiment, a transparent, split outer mold and a replaceable, water-soluble inner core can be used to prepare a transparent, flexible heart phantom. For example... Figure 5 As shown, the transparent split outer mold can be composed of two parts, left and right, and is made of acrylic, plexiglass, or other transparent rigid materials. A replaceable water-soluble inner core is placed inside the transparent split outer mold to define the cavity of the transparent flexible heart phantom. During casting, the operator can observe the flow of the transparent elastic material, residual air bubbles, and the position of the inner core through the outer mold. After curing, the transparent split outer mold is disassembled and the inner core is dissolved.

[0050] In the above-mentioned transparent split outer mold and replaceable water-soluble inner core combination mold, the replaceable water-soluble inner core is preferably a polyvinyl alcohol inner core; the transparent split outer mold can be reused to reduce material consumption caused by repeated printing of the outer mold.

[0051] In some embodiments of the present invention, the water-soluble material is polyvinyl alcohol.

[0052] The pulsatile transparent heart model experimental platform for left atrial appendage occlusion described in this invention can be used for preoperative planning of left atrial appendage occlusion, catheter pathway training, occluder release training, occluder position observation, occlusion effect observation, or in vitro verification of occlusion effect.

[0053] like Figure 4 As shown, the specific application method is as follows: The pneumatic drive interface is connected to the pneumatic drive device via a pneumatic drive pipeline, and the air supply frequency and pressure are set. Gas is periodically input and / or discharged into the cavity within the transparent flexible heart phantom via the pneumatic drive device, causing the transparent flexible heart phantom to undergo periodic pulsating deformation. A guidewire, catheter, sheath, or left atrial appendage occluder delivery system is then inserted through the interventional operation channel to deliver the occluder to the left atrial appendage simulation module. This allows for non-therapeutic left atrial appendage occlusion simulation in vitro, catheter path training, occluder release training, occluder position observation, occlusion effect observation, or in vitro verification of the occlusion effect. The deployment, adhesion, release, retrieval, and stabilization of the occluder are observed externally within the transparent flexible heart phantom. By repeatedly observing the occluder position changes during pulsation, it can be used to determine whether the occluder stably adheres to the left atrial appendage opening, whether displacement has occurred, and whether there is any possible residual gap.

[0054] The above content is only for illustrating the technical concept of the present invention and should not be construed as limiting the scope of protection of the present invention. Any modifications made to the technical solution based on the technical concept proposed in this invention shall fall within the scope of protection of this invention.

Claims

1. An experimental platform for left atrial appendage occlusion using a pulsatile transparent heart model, characterized in that, The device includes a transparent flexible heart phantom and a pneumatic drive device. The transparent flexible heart phantom includes a transparent flexible heart phantom body, an interventional operation channel connected to the transparent flexible heart phantom body, and a pneumatic drive interface. The pneumatic drive device is used to connect to the pneumatic drive interface through a pneumatic drive pipeline and to cause the transparent flexible heart phantom body to produce periodic pulsatile deformation through periodic air supply and / or air exhaust. The transparent flexible heart phantom body has a cavity inside. The transparent flexible heart phantom body includes a left atrial simulation module and a left atrial appendage simulation module connected to the left atrial simulation module. The interventional operation channel is connected to the cavity and allows the left atrial appendage occluder delivery system to enter. The pneumatic drive interface is separately set from the interventional operation channel.

2. The experimental platform for left atrial appendage occlusion using a pulsating transparent heart model according to claim 1, characterized in that, The volume of the left atrial appendage simulation module accounts for 5% to 8% of the total volume of the transparent flexible heart phantom body.

3. The experimental platform for left atrial appendage occlusion using a pulsating transparent heart model according to claim 1, characterized in that, The pneumatic drive interface and the interventional operation channel are located at different ends, different sidewalls, or different directions of the transparent flexible heart phantom body; when the pneumatic drive device is connected to the pneumatic drive interface through the pneumatic drive pipeline, the pneumatic drive pipeline avoids the observation area of ​​the left atrial appendage simulation module and the operation path of the interventional device.

4. The experimental platform for left atrial appendage occlusion using a pulsating transparent heart model according to claim 1, characterized in that, The transparent flexible heart phantom is made of a transparent or semi-transparent elastic material.

5. The experimental platform for left atrial appendage occlusion using a pulsating transparent heart model according to claim 1, characterized in that, The left atrial appendage simulation module and the left atrium simulation module are detachably connected.

6. The method for preparing the experimental platform for left atrial appendage occlusion using a pulsating transparent heart model according to any one of claims 1 to 5, characterized in that, The transparent flexible heart phantom is prepared by a water-soluble material sacrificial mold, a transparent split outer mold and a replaceable water-soluble inner core combined mold or a casting mold.

7. The method for preparing the experimental platform for left atrial appendage occlusion using a pulsating transparent heart model according to claim 6, characterized in that, The transparent flexible heart phantom was prepared using a water-soluble material sacrificial mold, and the preparation method is as follows: Based on the target shape of the required transparent and flexible heart phantom, a three-dimensional model is created to obtain the mold model; Based on the mold model, a water-soluble material is used for 3D printing to obtain a sacrificial mold made of water-soluble material; A transparent elastic material is poured into the interior of a water-soluble material sacrificial mold. After pouring, the material is cured and molded to form a transparent and flexible heart phantom inside the water-soluble material sacrificial mold. The transparent flexible heart phantom with a water-soluble material sacrificial mold is immersed in water to dissolve the water-soluble material sacrificial mold, thus obtaining the transparent flexible heart phantom body.

8. The method for preparing the experimental platform for left atrial appendage occlusion using a pulsating transparent heart model according to claim 7, characterized in that, The water-soluble material is polyvinyl alcohol.

9. The method for preparing the experimental platform for left atrial appendage occlusion using a pulsating transparent heart model according to claim 6, characterized in that, The transparent split outer mold and replaceable water-soluble inner core combined mold includes a transparent split outer mold and a replaceable water-soluble inner core. The transparent split outer mold consists of two parts; the preparation method is as follows: Based on the target shape of the required transparent and flexible heart phantom, a three-dimensional model was created to obtain a transparent split outer model and a replaceable water-soluble inner core. A replaceable water-soluble inner core is placed in a transparent split outer mold, and a mold cavity is formed between the transparent split outer mold and the replaceable water-soluble inner core; A transparent elastic material is poured into the mold cavity, and the flow of the transparent elastic material, residual air bubbles, and the location of the replaceable water-soluble inner core are observed. After the transparent elastic material solidifies, a transparent flexible heart phantom body is formed in the mold cavity. The two parts of the transparent split outer mold are separated, and the transparent flexible heart phantom with a replaceable water-soluble inner core is taken out and soaked in water to dissolve the replaceable water-soluble inner core, thus obtaining the transparent flexible heart phantom body.

10. The application of the pulsatile transparent heart model experimental platform for left atrial appendage occlusion as described in any one of claims 1 to 5 in preoperative planning, catheter pathway training, occluder release training, occluder position observation, occlusion effect observation, or in vitro verification of occlusion effect in left atrial appendage occlusion, characterized in that, The pneumatic drive interface is connected to an air pump through a pneumatic drive pipeline. Gas is introduced into the cavity inside the transparent flexible heart phantom through the air pump, causing the transparent flexible heart phantom to produce periodic pulsating deformation. The occluder is then delivered from the interventional operation channel to the left atrial appendage simulation module for preoperative planning of left atrial appendage occlusion, catheter path training, occluder release training, occluder position observation, occlusion effect observation, or in vitro verification of occlusion effect.

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