Customized system for left atrial appendage occluder

Abstract

The present invention discloses a customization system for a left atrial appendage occluder, comprising an imaging module, a processing module, and a three-dimensional printer. The input end of the imaging module is connected to the output end of a detection device placed in the patient's heart, the output end of the imaging module is connected to the input end of the processing module, and the output end of the processing module is connected to the input end of the three-dimensional printer. The imaging module is used to perform three-dimensional imaging of the patient's heart by detecting cardiac electrophysiological signals with the aid of the detection device, thereby establishing a three-dimensional computer model of the patient's left atrium and left atrial appendage. The processing module is used to identify the characteristic parameters of the patient's left atrial appendage based on the three-dimensional computer model established by the imaging module, thereby determining the specification data of the left atrial appendage occluder. The three-dimensional printer is used to complete 3D printing according to the specification data of the left atrial appendage occluder. The present invention can provide patients with personalized customization services for left atrial appendage occluders quickly and effectively, and the customized left atrial appendage occluder has good adaptability and a high success rate of surgery.

Description

Technical Field

[0001] The present invention relates to a medical device customization system, in particular to a customization system for a left atrial appendage occluder. Background Art

[0002] Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Its incidence increases with age, reaching up to 10% in people over 75 years old. During AF, the atrial excitation rate reaches 300-600 beats per minute, often with rapid and irregular heartbeats, and the atria lose their effective contractile function. During AF, the contractile force of the left atrial appendage (LAA) decreases. Furthermore, the morphological characteristics of the LAA and its uneven trabeculae within it create eddies and slow blood flow within the LAA, promoting thrombus formation. Over 90% of left atrial thrombi in patients with non-valvular AF are located in the LAA. Once dislodged, these thrombi can travel through the aorta to the cerebral arteries, causing cerebral embolism, or stroke.

[0003] Currently, three main clinical approaches are used to prevent and treat stroke in patients with atrial fibrillation: anticoagulant therapy, surgical intervention, and percutaneous left atrial appendage occlusion. Percutaneous left atrial appendage occlusion involves percutaneous puncture, using a small diameter delivery sheath to deliver a left atrial appendage occluder to the left atrium of the heart and then release it. The left atrial appendage occluder blocks the opening of the left atrial appendage, preventing blood flow from the atrium into the left atrial appendage and thus preventing thrombus formation, thereby preventing thromboembolism caused by atrial fibrillation.

[0004] The existing left atrial appendage occluder 50 generally consists of a sealing portion (or occluding disc) 52 and an anchoring portion (or fixing disc) 51, such as Figure 2 As shown, the anchoring portion 51 is primarily used to secure the entire LAA occluder at the LAA opening, and the sealing portion 52 is primarily used to radially expand and seal the LAA opening upon reaching the LAA opening. However, in actual applications, it has been found that existing LAA occluders have the following drawbacks: Currently, LAA occluders are designed based on the conventional dimensions of the human LAA, but the LAA structures of different people vary and are not identical. For example, some are larger, some are smaller, and the structures are also different. Figure 1A to Figure 1C The figure shows three different left atrial appendage anatomical structures. As can be seen from the figure, due to individual differences in left atrial appendage structures, existing left atrial appendage occluders often fail to fully align with the target tissue, such as the left atrial appendage opening, during surgery. This leads to poor adhesion and sealing, resulting in poor surgical results. This clearly needs to be addressed. Summary of the Invention

[0005] The purpose of the present invention is to provide a customization system for left atrial appendage occluder, which can quickly and effectively provide patients with personalized customization services for left atrial appendage occluder. The customized left atrial appendage occluder has good adaptability and greatly improves the success rate of the operation.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] A customized system for a left atrial appendage occluder, characterized in that it includes an imaging module, a processing module, and a 3D printer, wherein the input end of the imaging module is connected to the output end of a detection device placed in the patient's heart, the output end of the imaging module is connected to the input end of the processing module, and the output end of the processing module is connected to the input end of the 3D printer, wherein:

[0008] The imaging module is used to perform three-dimensional imaging of the patient's heart by detecting cardiac electrophysiological signals with the aid of the detection device, thereby establishing a three-dimensional computer model of the patient's left atrium and left atrial appendage;

[0009] The processing module is used to identify characteristic parameters of the patient's left atrial appendage based on the three-dimensional computer model established by the imaging module, thereby determining specification data of the left atrial appendage occluder and realizing personalized customization of the left atrial appendage occluder for the patient;

[0010] The three-dimensional printer is used to complete 3D printing according to the specification data of the left atrial appendage occluder determined by the processing module.

[0011] The advantages of the present invention are:

[0012] This invention provides patients with a personalized LAA occluder service. Based on the actual three-dimensional structure and dimensions of the patient's left atrium and LAA, this device can be quickly and efficiently customized to a highly compatible LAA occluder. This ensures optimal alignment between the device and the target tissue (the LAA opening), significantly improving the device's adherence and sealing properties, enhancing surgical outcomes and avoiding repeated occlusion procedures. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1A to Figure 1C These are schematic diagrams of three different left atrial appendage anatomical structures.

[0014] Figure 2 FIG. 1 is a structural diagram of an example of an existing left atrial appendage occluder.

[0015] Figure 3 It is a schematic diagram of the composition of the first embodiment of the customization system of the present invention.

[0016] Figure 4 This is a schematic diagram of the composition of the imaging module.

[0017] Figure 5 It is a schematic diagram illustrating the characteristic parameters of the left atrial appendage.

[0018] Figure 6 It is a schematic diagram of the composition of the processing module.

[0019] Figure 7 It is a schematic diagram of the composition of the second embodiment of the customization system of the present invention.

[0020] Figure 8 This is a schematic diagram of the composition of the release module.

[0021] Figure 9 It is a schematic diagram of the composition of the third embodiment of the customization system of the present invention. DETAILED DESCRIPTION

[0022] For ease of description and understanding, “proximal end” and “distal end” are defined in the present invention. The “proximal end” refers to the end close to the operator (such as a doctor), and the “distal end” refers to the end far away from the operator.

[0023] See also Figure 3 The present invention provides a customization system 1 for a left atrial appendage occluder. Specifically, a first embodiment of the customization system 1 of the present invention includes an imaging module 10, a processing module 20, and a 3D printer 30. The input end of the imaging module 10 is connected to the output end of a detection device 70 placed in the patient's heart 60. The output end of the imaging module 10 is connected to the input end of the processing module 20. The output end of the processing module 20 is connected to the input end of the 3D printer 30.

[0024] As explained herein, the detection device 70 is any device placed within the patient's heart 60 and used to detect electrophysiological signals (cardiac activity) from the patient's heart 60 in order to construct a three-dimensional computer model of the relevant portion of the patient's heart. The detection device 70 may be a device already known in the art. For example, the detection device 70 may be a catheter equipped with ablation electrodes for detecting the patient's heart's electrical activity.

[0025] The imaging module 10 is used to perform three-dimensional imaging of the patient's heart 60 by detecting cardiac electrophysiological signals with the aid of the detection device 70, thereby establishing a three-dimensional computer model of the patient's left atrium and left atrial appendage.

[0026] In actual implementation, optionally, the anatomical imaging of the patient's left atrium and left atrial appendage can be mapped and combined with the electrical activity map of the patient's left atrium and left atrial appendage to perform three-dimensional imaging, thereby realizing the establishment of a three-dimensional computer model of the left atrium and left atrial appendage, wherein the electrophysiological signals (electrical activity) of the patient's left atrium and left atrial appendage can be detected by a detection device 70 placed inside the patient's heart.

[0027] In the present invention, the electrophysiological signals of the heart are used to reflect the cardiac electrical activity and are usually represented by electrocardiograms. The electrophysiological signals of the left atrium and left atrial appendage are used to reflect their electrical activities and are usually represented by electrocardiograms.

[0028] The processing module 20 is used to identify the characteristic parameters of the patient's left atrial appendage based on the three-dimensional computer model established by the imaging module 10, thereby determining the specification data of the left atrial appendage occluder and realizing personalized customization of the left atrial appendage occluder for the patient.

[0029] In the present invention, the processing module 20 is used to receive and process data, and control other modules. For example, the processing module 20 is used to receive model data fed back by the imaging module 10 and process the model data, and to control the printing operation of the 3D printer 30, etc.

[0030] The processing module 20 is a well-known device in the art and can be a general processor, a digital signal processor (DSP), a microprocessor, an integrated circuit (ASIC), a field programmable gate array (FPGA) circuit or other type of integrated circuit (IC), a state machine, etc., without limitation.

[0031] In practical applications, the processing module 20 can send the determined specification data of the left atrial appendage occluder to the 3D printer 30 to control the 3D printer 30 to print according to the specification data to obtain a personalized left atrial appendage occluder. Figure 2 , the figure exemplarily shows a left atrial appendage occluder printed by a three-dimensional printer 30.

[0032] The three-dimensional printer 30 is used to complete 3D printing according to the specification data of the left atrial appendage occluder determined by the processing module 20.

[0033] The present invention adopts three-dimensional printing, which can improve manufacturing efficiency, extend service life and reduce costs. The three-dimensional printer 30 is a 3D printer, and its resolution, printing size and other parameters can be set as needed to print the required left atrial appendage occluder.

[0034] In 3D printing, different parts of the left atrial appendage occluder can be printed using the same or different printing materials. These materials can be metals such as cobalt-chromium alloy and stainless steel, or biodegradable materials. These materials can be biodegradable metals or biodegradable polymers, such as polylactic acid, polycaprolactone, or polydioxanone. Silicone materials can also be used. In short, the printing material is not limited and can be selected based on actual needs.

[0035] In the present invention, the printing process is not limited. For example, traditional manufacturing technologies such as wire bending, polymer extrusion, thermoforming, injection molding and CNC machining can be used, and joining technology can also be used.

[0036] like Figure 3 The imaging module 10 of the first embodiment of the customization system 1 of the present invention uses the detection device 70 to perform three-dimensional imaging of the patient's heart, establishes a three-dimensional computer model of the patient's left atrium and left atrial appendage, and then processes the model data of the three-dimensional computer model through the processing module 20 to obtain the characteristic parameters of the patient's left atrial appendage, thereby determining the specification data of a personalized left atrial appendage occluder suitable for the patient. A printing instruction is then sent to the three-dimensional printer 30, and the three-dimensional printer 30 prints the left atrial appendage occluder based on the received specification data, completing the customization of the personalized left atrial appendage occluder suitable for the patient. The customized left atrial appendage occluder has strong wall adhesion and high sealing. Compared with the existing technology, the surgical effect is greatly improved, avoiding the need for repeated occlusion treatment operations.

[0037] In actual design, further, if Figure 4 The imaging module 10 further includes a determination unit 101 and a reconstruction unit 102. The input end of the determination unit 101 is connected to the output end of the detection device 70, and the output end of the determination unit 101 is connected to the input end of the processing module 20 via the reconstruction unit 102, wherein:

[0038] The determining unit 101 is configured to perform three-dimensional imaging based on the cardiac electrophysiological signal (cardiac electrical activity) detected by the receiving detection device 70 , so as to establish an anatomical model of the patient's heart.

[0039] In the present invention, three-dimensional imaging can be computed axial tomography (CT) scanning imaging, multi-detector computed tomography (MDCT) imaging, magnetic resonance imaging (MRI), ultrasonic cardiac imaging, transesophageal echocardiography (TEE) imaging or other existing imaging technologies, without limitation.

[0040] Given the complex structure of the heart and the numerous surrounding vascular branches and tissues, image segmentation technology is needed to extract clear cardiac contour data from three-dimensional imaging images to determine the anatomical model of the patient's heart (especially the left atrium and left atrial appendage). This is then positioned in the six directions of the human anatomy: up, down, left, right, front, and back. This generates axial, coronal, and sagittal views for easy observation, completing the establishment of the patient's heart anatomical model.

[0041] From a practical point of view, the anatomical model of the patient's heart established through three-dimensional imaging has the problem of a slightly rough surface. Some tiny burrs and irrelevant tissue structures will directly affect the printing effect of the physical left atrial appendage occluder. Therefore, the present invention designs a reconstruction unit 102, which will further reconstruct a three-dimensional computer model of the patient's left atrium and left atrial appendage based on the anatomical model of the patient's heart established by the determination unit 101.

[0042] Specifically, the reconstruction unit 102 is used to smooth and optimize the anatomical model of the patient's heart, extracting and reconstructing a three-dimensional computer model of the patient's left atrium and left atrial appendage (LAA). This allows the processing module 20 to measure the characteristic parameters of the LAA based on the model data and determine the specifications of the LAA occluder. The smoothing process involves removing rough areas on the surface of the anatomical model to remove fine burrs, and the optimization process involves removing tissue structures in the anatomical model that are irrelevant to the LAA occluder (e.g., complex (appearingly rough) tissue areas that the LAA occluder would not pass through). This reduces the computational complexity of the subsequent processing module 20 and improves computational accuracy.

[0043] like Figure 5 As shown, the characteristic parameters of the left atrial appendage involved in the present invention include the opening diameter (Dk), the occlusion area diameter (Df), the anchoring area diameter (Dm), the opening depth (Hk), the atrial appendage depth (Hx), and the residual depth (Hs). The characteristic parameters of the left atrial appendage are not limited to the above-mentioned characteristic parameters. The definition rules of these characteristic parameters are all existing rules in the field and are not detailed here.

[0044] It should be noted here that, in order to ensure data accuracy when the characteristic parameter information of the left atrial appendage is counted as described above, the left atrium connected to the left atrial appendage needs to be reconstructed together during reconstruction by the reconstruction unit 102, that is, a three-dimensional computer model of the patient's left atrium and left atrial appendage needs to be reconstructed.

[0045] In actual design, Figure 6 As shown, the processing module 20 further includes a recognition unit 201 and a customization unit 202. The input end of the recognition unit 201 is connected to the output end of the imaging module 10 or the reconstruction unit 102, and the output end of the recognition unit 201 is connected to the input end of the 3D printer 30 via the customization unit 202.

[0046] The recognition unit 201 is used to recognize the model data of the three-dimensional computer model sent by the imaging module 10 to obtain characteristic parameters of the patient's left atrial appendage;

[0047] The customization unit 202 is configured to determine specification data of the left atrial appendage occluder based on the left atrial appendage characteristic parameters after the identification unit 201 identifies the left atrial appendage characteristic parameters.

[0048] Here, the specification data of the left atrial appendage occluder includes the specification data of the sealing portion 52 and the specification data of the anchor portion 51 . Of course, the specification data of the left atrial appendage occluder is not limited to the above.

[0049] In this field, specification data refers to parameters such as volume and size, and size refers to diameter, height, etc. In the present invention, the specification data of the left atrial appendage occluder include the maximum cross-sectional diameter, height and volume of the sealing portion 52 after radial contraction and the maximum cross-sectional diameter, height and volume of the sealing portion 52 after radial expansion, as well as the maximum cross-sectional diameter, height and volume of the anchoring portion 51, such as Figure 2 shown.

[0050] The existing left atrial appendage occluder 50 generally includes a sealing portion 52 and an anchoring portion 51, such as Figure 2 , the sealing portion 52 and the anchoring portion 51 are interconnected. Relative to the operator, the sealing portion 52 is at the proximal end and the anchoring portion 51 is at the distal end. The anchoring portion 51 is mainly used to fix the left atrial appendage occluder at the left atrial appendage opening position. The maximum cross-sectional diameter d1 and height (or depth) h1 of the anchoring portion 51 are determined according to the characteristic parameters of the anchoring area diameter (Dm), the atrial appendage depth (Hx) and the remaining depth (Hs). The sealing portion 52 is mainly used to radially expand and block the left atrial appendage opening when the left atrial appendage occluder reaches the left atrial appendage opening position, thereby blocking the thrombus inside the left atrial appendage and effectively preventing the thrombus from entering the left atrium. The maximum cross-sectional diameter d2 and height (depth) h2 of the sealing portion 52 after radial expansion are determined according to the characteristic parameters of the occlusion area diameter (Df), the opening diameter (Dk), the atrial appendage depth (Hx) and the opening depth (Hk). Because Figure 2 The figure shows the state of the sealing portion 52 when it is contracted, so the maximum diameter d2 and height h2 of the cross section after radial expansion are not in the Figure 2 As shown in FIG, please understand it based on the maximum cross-sectional diameter d1 and height h1 of the anchor portion 51.

[0051] From the experiment, it can be seen that after the specification data of the left atrial appendage occluder is determined based on the identified left atrial appendage characteristic parameters, the left atrial appendage occluder 3D printed based on the specification data can perfectly block the opening of the left atrial appendage with a good blocking effect. This prevents the blood flow in the atrium from entering the left atrial appendage, effectively avoids thrombosis, and achieves the purpose of preventing atrial fibrillation thromboembolism.

[0052] After completing the customization of the above-mentioned personalized left atrial appendage occluder, the left atrial appendage occluder needs to be delivered percutaneously into the patient's left atrial appendage. During actual operation, the delivery sheath for delivering the left atrial appendage occluder is inserted percutaneously into a large vein (such as the femoral vein or jugular vein) and advanced to the patient's vena cava, and then enters the right atrium under the guidance of a fluoroscope. The delivery sheath advances through the atrial septum and enters the patient's left atrium, and then the personalized left atrial appendage occluder is deployed on the outside of the delivery sheath inside the patient's left atrial appendage. Once the sealing portion 52 of the left atrial appendage occluder is released and expanded in the left atrium, that is, when it is radially expanded to the maximum cross-sectional size, the left atrial appendage opening will be blocked.

[0053] In actual implementation, the delivery of the LAA occluder through the delivery sheath usually requires the doctor (operator) to determine the release path based on experience, which undoubtedly increases the technical requirements for the doctor and is very likely to cause the release to be unsuccessful or fail due to lack of experience. Figure 7 As shown, the present invention proposes a second embodiment of a customized system 1 for a left atrial appendage occluder. In addition to having the same structure as the first embodiment of the present invention, the second embodiment further includes a release module 40. The two input ends of the release module 40 are respectively connected to the output end of the detection device 70 and the output end of the processing module 20, wherein:

[0054] The release module 40 is used to plan a release path for the customized personalized left atrial appendage occluder. The release path is used to assist the doctor (operator) to smoothly release the left atrial appendage occluder to the patient's left atrial appendage opening, so that the left atrial appendage occluder released in place can achieve good occlusion of the left atrial appendage opening.

[0055] From the perspective of actual implementation, the release path calculated by the release module 40 for the customized left atrial appendage occluder no longer relies on the doctor's experience, ensures smooth and accurate release, and reduces the difficulty of the operation.

[0056] In actual design, Figure 8 As shown, the release module 40 further includes a receiving unit 401 and a calculation unit 402, the input end of the receiving unit 401 is connected to the output end of the detection device 70 and the output end of the processing module 20, and the output end of the receiving unit 401 is connected to the input end of the calculation unit 402, wherein:

[0057] The receiving unit 401 is used to receive the patient's cardiac electrophysiological signal (electrocardiogram) detected by the detection device 70 and the specification data of the left atrial appendage occluder determined by the processing module 20;

[0058] The calculation unit 402 is used to plan multiple release paths between the patient's skin and the patient's left atrial appendage based on the cardiac electrophysiological signal sent by the receiving unit 401 and the specification data of the left atrial appendage occluder.

[0059] Specifically, before occluding the patient's left atrial appendage, the computing unit 402 determines the body parts between the patient's skin and the patient's left atrium, the necrotic tissue that the left atrial appendage occluder cannot access, based on the cardiac electrophysiological signals (the electrocardiogram can reflect necrotic tissue that does not conduct signals), and determines the tissue parts that are difficult to access and cannot be reached by the left atrial appendage occluder based on the specification data of the left atrial appendage occluder, thereby planning multiple feasible release paths for releasing the left atrial appendage occluder between the patient's skin and the patient's left atrial appendage.

[0060] In actual implementation, Figure 7The second embodiment of the customized system 1 for the left atrial appendage occluder of the present invention further includes a display module 80, the input end of the display module 80 is connected to the output end of the release module 40 or the calculation unit 402, wherein:

[0061] Display module 80 displays the planned release paths for the physician to select. Typically, the physician selects the optimal release path and, during surgery, deploys the LAA occluder based on the display on display module 80 and with the aid of guidance equipment (e.g., fluoroscope).

[0062] In practice, once the LAA occluder is in place at the LAA opening, the treatment procedure can begin. During the procedure, multiple ablation electrodes on the LAA occluder are typically used to measure electrical signals reflecting the patient's heart rhythm. If the patient is experiencing an abnormal heart rhythm (such as atrial fibrillation), the measured electrical signals can be used to help the doctor diagnose and locate the abnormal rhythm. Ablation energy (such as treatment pulses) is then applied to create the desired pattern of ablation lesions to prevent further arrhythmia.

[0063] It can be seen that after customizing a personalized left atrial appendage occluder, ablation electrodes can be added thereto to achieve the above-mentioned ablation function.

[0064] The ablation electrode is an existing component in this field, and can be understood by referring to the ablation electrode disclosed in the Chinese invention patent application “Left Atrial Appendage Occlusion Ablation System” with publication number CN114903587A.

[0065] Therefore, in actual design, an ablation electrode module 90 may be further provided for the first and second embodiments of the present invention. The input end of the ablation electrode module 90 is connected to the output end of the processing module 20 or the customization unit 202, wherein:

[0066] The ablation electrode module 90 is used to determine the number of ablation electrodes used to achieve the ablation function and the layout positions of the ablation electrodes on the left atrial appendage occluder according to the specification data of the left atrial appendage occluder output by the processing module 20, that is, to complete the determination of the ablation electrode layout parameters.

[0067] Figure 9 FIG2 shows a case where an ablation electrode module 90 is additionally provided based on the second embodiment of the present invention. For a case where an ablation electrode module 90 is additionally provided based on the first embodiment of the present invention, please refer to FIG2. Figure 9 Just come and understand.

[0068] In actual implementation, the output end of the ablation electrode module 90 can be directly connected to the input end of the 3D printer 30, that is, the ablation electrode module 90 can send the determined ablation electrode layout parameters to the 3D printer 30, so that the 3D printer 30 can complete 3D printing based on the specification data of the left atrial appendage occluder sent by the processing module 20 and the ablation electrode layout parameters, and finally obtain a left atrial appendage occluder with both blocking and ablation functions.

[0069] Alternatively, the ablation electrode module 90 is not connected to the 3D printer 30. The 3D printer 30 only prints out a left atrial appendage occluder with an occluding function based on the specification data of the left atrial appendage occluder sent by the processing module 20, and then fixes the ablation electrode on the printed left atrial appendage occluder by manual processing according to the ablation electrode arrangement parameters determined by the ablation electrode module 90. The material of the ablation electrode can be platinum, iridium, gold or silver, etc., which are medical metal materials that can be used for interventional treatment.

[0070] As a result, the final customized left atrial appendage occluder combines ablation and occlusion functions very well, greatly simplifying the difficulty of the operation and achieving "ablation + left atrial appendage occlusion" treatment in one stop.

[0071] The advantages of the present invention are:

[0072] This invention provides patients with a personalized LAA occluder service. Based on the actual three-dimensional structure and dimensions of the patient's left atrium and LAA, this device can be quickly and efficiently customized to a highly compatible LAA occluder. This ensures optimal alignment between the device and the target tissue (the LAA opening), significantly improving the device's adherence and sealing properties, enhancing surgical outcomes and avoiding repeated occlusion procedures.

[0073] The above are preferred embodiments of the present invention and the technical principles used therein. For those skilled in the art, any obvious changes such as equivalent transformations, simple replacements, etc. based on the technical solution of the present invention, without departing from the spirit and scope of the present invention, are within the scope of protection of the present invention.

Claims

1. A customized system for a left atrial appendage occluder, characterized in that: The system comprises an imaging module, a processing module and a 3D printer, wherein the input end of the imaging module is connected to the output end of a detection device placed in the patient's heart, the output end of the imaging module is connected to the input end of the processing module, and the output end of the processing module is connected to the input end of the 3D printer, wherein: The imaging module is used to perform three-dimensional imaging of the patient's heart by detecting cardiac electrophysiological signals with the aid of the detection device, thereby establishing a three-dimensional computer model of the patient's left atrium and left atrial appendage; The imaging module includes a determination unit and a reconstruction unit, wherein the reconstruction unit is configured to smooth and optimize the anatomical model of the patient's heart, extract and reconstruct a three-dimensional computer model of the patient's left atrium and left atrial appendage, wherein the smoothing includes smoothing rough areas on the surface of the anatomical model of the patient's heart to remove fine burrs, and the optimization includes removing tissue structures in the anatomical model of the patient's heart that are not related to the left atrial appendage occluder; The processing module is used to identify characteristic parameters of the patient's left atrial appendage based on the three-dimensional computer model established by the imaging module, thereby determining specification data of the left atrial appendage occluder and realizing personalized customization of the left atrial appendage occluder for the patient; The processing module includes an identification unit and a customization unit, wherein: the identification unit is used to identify the model data of the three-dimensional computer model sent by the imaging module to obtain characteristic parameters of the patient's left atrial appendage; the customization unit is used to determine the specification data of the left atrial appendage occluder based on the left atrial appendage characteristic parameters after the identification unit identifies the left atrial appendage characteristic parameters; The characteristic parameters of the left atrial appendage include opening diameter, occlusion area diameter, anchoring area diameter, opening depth, atrial appendage depth and remaining depth, wherein the left atrial appendage occluder includes a sealing portion and an anchoring portion; The specification data of the left atrial appendage occluder include the maximum cross-sectional diameter, height, and volume of the sealing portion after radial contraction and expansion, and the maximum cross-sectional diameter, height, and volume of the anchoring portion, wherein: the maximum cross-sectional diameter and height of the anchoring portion are determined based on the anchoring region diameter, the atrial appendage depth, and the remaining depth; and the maximum cross-sectional diameter and height of the sealing portion after radial expansion are determined based on the occlusion region diameter, the opening diameter, the atrial appendage depth, and the opening depth; The three-dimensional printer is used to complete 3D printing according to the specification data of the left atrial appendage occluder determined by the processing module.

2. The customization system for the left atrial appendage occluder according to claim 1, characterized in that: The input end of the determination unit is connected to the output end of the detection device, and the output end of the determination unit is connected to the input end of the processing module via the reconstruction unit, wherein: The determining unit is configured to perform three-dimensional imaging based on the cardiac electrophysiological signals detected by the detecting device to establish an anatomical model of the patient's heart; The reconstruction unit is used to reconstruct a three-dimensional computer model of the patient's left atrium and left atrial appendage based on the anatomical model of the patient's heart established by the determination unit.

3. The customization system for the left atrial appendage occluder according to claim 1, characterized in that: The input end of the recognition unit is connected to the output end of the imaging module, and the output end of the recognition unit is connected to the input end of the three-dimensional printer via the customization unit.

4. The customization system for the left atrial appendage occluder according to claim 1, characterized in that: The customization system for the left atrial appendage occluder further includes a release module, wherein two input ends of the release module are respectively connected to the output end of the detection device and the output end of the processing module, wherein: The release module is used to plan a release path for the customized personalized left atrial appendage occluder, and the release path is used to assist doctors in smoothly releasing the left atrial appendage occluder to the patient's left atrial appendage opening, so that the left atrial appendage occluder released in place can occlude the left atrial appendage opening.

5. The customization system for the left atrial appendage occluder according to claim 4, characterized in that: The release module includes a receiving unit and a calculation unit, wherein the input end of the receiving unit is connected to the output end of the detection device and the output end of the processing module, and the output end of the receiving unit is connected to the input end of the calculation unit, wherein: The receiving unit is used to receive the patient's cardiac electrophysiological signal detected by the detection device and the specification data of the left atrial appendage occluder determined by the processing module; The calculation unit is used to plan multiple release paths between the patient's skin and the patient's left atrial appendage based on the cardiac electrophysiological signal sent by the receiving unit and the specification data of the left atrial appendage occluder.

6. The customization system for the left atrial appendage occluder according to claim 5, characterized in that: Before occluding the patient's left atrial appendage, the computing unit determines the body parts between the patient's skin and the patient's left atrium, the necrotic tissue that the left atrial appendage occluder cannot access based on the cardiac electrophysiological signals, and the tissue parts that are difficult to access and cannot be reached by the left atrial appendage occluder based on the specification data of the left atrial appendage occluder, thereby planning multiple feasible release paths between the patient's skin and the patient's left atrial appendage for releasing the left atrial appendage occluder.

7. The customization system for the left atrial appendage occluder according to claim 4, characterized in that: The customization system for the left atrial appendage occluder further includes a display module, the input end of which is connected to the output end of the release module, wherein: The display module is used to display the planned release paths for the doctor to freely choose.

8. The customization system for the left atrial appendage occluder according to claim 1 or 4, characterized in that: The customized system for the left atrial appendage occluder further includes an ablation electrode module, the input end of which is connected to the output end of the processing module, wherein: The ablation electrode module is used to determine the number of ablation electrodes used to achieve the ablation function and the layout position of the ablation electrodes on the left atrial appendage occluder according to the specification data of the left atrial appendage occluder output by the processing module, wherein the ablation electrode module is connected to the three-dimensional printer or not connected to the three-dimensional printer.

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