Ventricular septal defect plugging apparatus and use method thereof

Abstract

The invention relates to a ventricular septal defect plugging instrument and a use method thereof. The ventricular septal defect plugging instrument comprises a left ventricular plugging disc, an expansion body, a right ventricular plugging disc and an elastic traction rod. The high polymer material bidirectional plugging disc with strength and elasticity is adopted and can fully adapt to the complex shape of the ventricular wall, and reliable plugging is achieved during and after an operation; the expansion body capable of automatically filling is adopted, so that the plugging disc can be tightly connected, complex defect holes can be automatically filled, and ventricular septal defects of different sizes can be adapted; the elastic traction rod is adopted and detachably connected with the expansion body, so that the expansion body can be accurately implanted into a defect part, excessive traction damage of an instrument to cardiac cavity tissue in an operation is avoided, the expansion body can be separated after being positioned, foreign matter is not left to influence normal functions of the heart, meanwhile, the operation process can be simplified, the operation time is shortened, and the operation difficulty is reduced; the survival rate of the patient is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a ventricular septal defect closure device and its usage method. Background Technology

[0002] Ventricular septal defect (VSD) is the most common type of congenital heart disease, accounting for approximately 20%-30% of all congenital heart defects. Traditional surgical repair has long been considered the gold standard for treating VSD. VSD can be classified according to its anatomical location into perimembranous VSD (PMVSD), muscular VSD (MVSD), inflow tract type, and outflow tract type (or sub-arterial type).

[0003] Currently, with the development of interventional catheter technology, more and more occluders are being used for VSD, but the results are still not satisfactory, especially for VSD after myocardial infarction and post-traumatic VSD. Interventional catheter treatment is simply ineffective, so surgical treatment remains an important treatment method and will continue to be the gold standard for treating VSD.

[0004] However, surgical treatment still has significant limitations in post-myocardial infarction VSD and post-traumatic VSD: 1. The shape of the defect is extremely complex and scattered, often with many holes forming a spider web-like pattern inside; 2. Ventricular fenestration carries high risks, so only atrial fenestration can be used, but atrial fenestration significantly limits the operation; 3. There are currently no surgical instruments on the market specifically for ventricular septal defects, and patch suturing is the most common method, which leads to high surgical difficulty, poor postoperative results, and extremely high mortality. Summary of the Invention

[0005] This invention addresses the technical problems existing in the prior art by providing a ventricular septal defect closure device and its usage method.

[0006] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: A ventricular septal defect closure device includes a left ventricular closure disc, an expandable body, a right ventricular closure disc, and an elastic traction rod. The elastic traction rod is detachably and fixedly connected to the expandable body for implanting the expandable body into the site to be closed. The two ends of the expandable body, which passes through the site to be closed, are fixedly connected to the left ventricular closure disc and the right ventricular closure disc, respectively. The left ventricular closure disc is used to conform to the left ventricle and the interventricular septum, and the right ventricular closure disc is used to conform to the right ventricle and the interventricular septum.

[0007] The beneficial effects of this invention are: 1. The bidirectional occlusion disc, made of high-molecular material, combines strength and elasticity, and can fully adapt to the complex shape of the ventricular wall, achieving reliable occlusion both during and after the procedure; 2. It adopts an expansion body that automatically fills gaps, which can not only tightly connect to the sealing plate, but also automatically fill complex defects and holes, adapting to ventricular septal defects of different sizes; 3. The use of an elastic traction rod, which is detachably connected to the expandable body, allows for precise implantation of the expandable body into the defect site, avoiding excessive traction damage to the cardiac tissues during surgery. It can also be detached after positioning, leaving no foreign body that could affect normal cardiac function. At the same time, it simplifies the operation process, reduces surgical time, lowers the difficulty of surgery, and improves the patient's survival rate.

[0008] Furthermore, both the left ventricular occlusion disc and the right ventricular occlusion disc are made of highly elastic and high-strength polyester fiber cloth, manufactured through a three-dimensional dense weaving process, with a thickness ranging from 0.15 to 1 mm. The high elasticity of the polyester fiber cloth allows the occlusion disc to adapt to the irregular shapes of the left and right ventricular walls, ensuring a tight fit without gaps. This solves the problem of blood leakage caused by poor fit in traditional rigid occlusion discs. The polyester fiber cloth is suitable for irregular defects that require on-site cutting. The three-dimensional dense weaving process gives the material excellent tear resistance, which can withstand the impact of blood flow during cardiac contraction and relaxation, preventing damage to the occlusion disc. At the same time, the dense structure ensured by the process results in water leakage of ≤300 ml / (cm²・min), providing outstanding sealing performance. Meanwhile, the thin design of 0.15~1 mm reduces the space occupied by the occlusion disc in the ventricular cavity, reducing interference with the activity of heart valves (such as the mitral and tricuspid valves) and preventing damage to valve function.

[0009] Furthermore, both the left ventricular occlusion disc and the right ventricular occlusion disc are made of silicone rubber or polyurethane, formed by casting, injection molding, rotational molding, or blow molding, with a thickness ranging from 0.2 to 1 mm and a hardness ranging from 10 to 80 degrees. Silicone rubber and polyurethane materials are completely waterproof, offering superior sealing performance compared to woven materials, directly preventing minor leaks caused by material pores. Casting, injection molding, rotational molding, or blow molding processes enable standardized mass production of the occlusion discs, ensuring consistency in form and performance across different batches, reducing compatibility risks during clinical use, and facilitating standardized mass production. Simultaneously, the 10-80 degree hardness range allows for flexible matching of ventricular wall elasticity in different patients (e.g., children versus adults, and stiffened myocardium versus normal myocardium after myocardial infarction), while the 0.2-1 mm thickness ensures both strength and flexibility, facilitating intraoperative position adjustment.

[0010] Furthermore, the left ventricular occlusion disc and right ventricular occlusion disc are square, round, or elliptical. The left ventricular occlusion disc and the expandable body are either an integral or separate structure. When separate, the expandable body and the left and right ventricular occlusion discs are fixed with sutures. On the one hand, the multi-shape design allows for the selection of suitable shapes for defects in different anatomical locations (such as perimembranous, muscular, and subarterial VSDs). For example, a round occlusion disc is suitable for central defects, while an elliptical one is suitable for long-axis defects, avoiding blind spots caused by shape mismatch. On the other hand, the integral structure allows for direct preoperative selection of specifications and rapid intraoperative use, shortening the operation time and making it suitable for emergencies (such as post-traumatic VSDs). The separate structure supports on-site suturing according to the size and location of the defect during the operation, eliminating the need for prefabrication of a large number of specifications, reducing instrument costs and clinical waste. It is especially suitable for multifocal and irregular defects after myocardial infarction, allowing doctors to flexibly combine the occlusion disc and the expandable body to improve individualized treatment outcomes.

[0011] Furthermore, the expandable body is made of expandable and biodegradable urethane material, and is cylindrical or frustum-shaped. The expandable properties of urethane material allow the expandable body to gradually expand after implantation by absorbing blood, tissue fluid, saline, heparinized water, etc., adaptively filling the defect space. This eliminates the need for precise prediction of the defect volume during surgery, reducing the difficulty of operation and adapting to regular defects. At the same time, its biodegradable properties allow the expandable body to gradually degrade into harmless metabolites after closure, avoiding the risks of tissue rejection and thrombosis caused by long-term foreign body retention. The preset cylindrical and frustum-shaped shapes can respectively adapt to tubular and funnel-shaped defects, ensuring a tight fit with the defect wall after expansion. Meanwhile, the three-dimensional mesh-like loose structure will not excessively compress the surrounding myocardial tissue during filling, protecting the conduction system and valve function.

[0012] Furthermore, the expansion body is made of silicone material, has a thin-walled tubular shape with a thickness of 0.05~0.2mm, small holes are opened on the tube wall, and a filling port is reserved after the head end is connected to the ventricular occlusion plate, and polyurethane foam is filled inside. First, the 0.05~0.2mm thin-walled silicone tube is highly flexible and can be shaped to fit any defect, even irregular porous defects after myocardial infarction. It can be completely fitted by filling with expanding foam, adapting to complex spider web-like defects. Second, the small pore design of the tube wall allows the expanding foam to overflow, filling tiny branch defects that the lumen cannot cover, eliminating the problem of incomplete filling in traditional occluders. Third, the high viscosity and 10~20 times expansion ratio of polyurethane foam can control the filling volume through precise calculation (redundancy 0~10%), avoiding excessive expansion and tissue compression. It can also bond tightly to the double occlusion disc after curing, forming a stable whole and preventing the occluder from falling off. Finally, the filling port design allows for on-site injection of expanding foam during the operation, eliminating the need for pre-prepared expandable bodies, adapting to defects of various unknown volumes, and improving the surgical error tolerance.

[0013] Furthermore, the elastic traction rod is made of any one of the following materials: silicone rubber, PE, PP, PEbax, PTFE, and PU. It has a hollow tube or solid rod structure with a diameter ranging from 1 to 10 mm and is connected to the expansion body via sutures. The polymer material combines good strength and elasticity, and the 1-10 mm diameter design allows it to easily pass through narrow cardiac chambers such as the tricuspid and mitral valves, avoiding valvular damage due to obstruction. The suture connection method is simple to operate, requiring no complex mechanical structure, reducing the risk of intraoperative instrument malfunction. Simultaneously, the sutures can be cut and separated after positioning, preventing any residue of the elastic traction rod.

[0014] Furthermore, the elastic traction rod is made of metal and takes the form of a guide wire or a hyaluronic acid tube, connecting to the expansion body via hooks. The high strength and fatigue resistance of the metal material allow it to maintain shape stability during long-distance traction, and it is not easily bent or deformed even through irregular defects or holes, ensuring precise positioning of the expansion body. The hook connection method allows for rapid assembly and disassembly, saving operation time compared to suture connections, and is especially suitable for emergency surgeries.

[0015] A method for using a ventricular septal defect closure device includes the following steps: S1. Path establishment: An elastic traction rod is inserted from the right atrial fenestration. The elastic traction rod passes through the tricuspid valve into the right ventricle, passes through the VSD defect hole into the left ventricle, and finally passes through the mitral valve in reverse and protrudes from the left atrial fenestration. S2. Instrument assembly and connection: The assembly of the left ventricular occlusion disc and the expansion body selected or sutured before the operation is connected to the end of the elastic traction rod by means of sutures or barbs. S3. Traction Positioning: Slowly pull the elastic traction rod to pull the assembly to the VSD position and ensure that the left ventricular occlusion disc fits tightly against the left ventricular wall; S4. Separation and Fixation: Disconnect the elastic traction rod from the assembly, suture the right ventricular occlusion disc to the expansion body, and ensure that the right ventricular occlusion disc fits against the right ventricular wall. S5. Confirm the effect: Check the fit of the sealing disc and the integrity of the expansion body filling to ensure there is no residual shunting and complete the operation.

[0016] The design of atrial fenestration and biventricular pathway avoids the high risks associated with left and right ventricular fenestration. At the same time, the elastic traction rod passes through the heart chamber to ensure precise implantation of the expandable body into the defect site, solving the problem of limited operating space in traditional surgery. The left ventricular occlusion disc is positioned first, and then the right ventricular occlusion disc is fixed. The step-by-step operation allows for gradual adjustment of the instrument position to ensure a tight fit between the two occlusion discs and reduce residual shunt.

[0017] Furthermore, if the expandable body is made of an expandable material, the right ventricular occlusion disc and the assembly can be directly sutured together. The expandable body expands by absorbing blood and tissue fluid, filling the defect in the ventricular septum. Alternatively, it can be stimulated to fully expand by injecting saline or heparin. If the expandable body is a foam-type expandable body, the right ventricular occlusion disc and the assembly must be sutured with close-needle overlock stitches to ensure that the foam does not leak into the right ventricle. During suturing, small pores in the expandable tube wall must be avoided. The expandable body is then filled and expanded by injecting polyurethane foam. Different fixation methods for different expandable bodies are used to precisely match material characteristics and avoid problems such as leakage or incomplete filling. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the occlusion device structure according to an embodiment of the present invention; Figure 2 This is a diagram showing the state of the sealing device before the expansion body expands according to an embodiment of the present invention; Figure 3 This is a diagram showing the state of the sealing device after the expansion body has expanded according to an embodiment of the present invention; Figure 4 This is a schematic diagram of the thin-walled tubular expansion body structure according to an embodiment of the present invention; Figure 5 This is a diagram showing the state of the thin-walled tubular expansion body after being filled with foam adhesive according to an embodiment of the present invention; Figure 6 This is a diagram of a lesion in the heart according to an embodiment of the present invention; Figure 7 This is a schematic diagram of the traction path of the elastic traction rod according to an embodiment of the present invention; Figure 8 This is a model diagram of the heart before the expansion body is expanded, according to an embodiment of the present invention. Figure 9 This is a diagram of a heart model after the expansion body has expanded according to an embodiment of the present invention; The attached diagram lists the components represented by each number as follows: 1. Left ventricle sealing disc; 2. Expansion body; 21. Thin-walled lumen; 22. Small hole; 23. Filling port; 3. Right ventricle sealing disc; 4. Elastic traction rod. Detailed Implementation

[0019] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0020] In the description of this application, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the stated features. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0021] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this technology based on the specific circumstances.

[0022] In the description of this application, spatial relation terms such as "below," "under," "below," "below," "above," "over," etc., are used herein to describe the relationship between one element or feature shown in the figures and other elements or features. It should be understood that, in addition to the orientation shown in the figures, spatial relation terms also include different orientations of the device in use and operation. For example, if the device in the figures is flipped, an element or feature described as "below" or "under" or "below" of other elements or features will be oriented "above" other elements or features. Therefore, the exemplary terms "below" and "under" can include both upper and lower orientations. Furthermore, the device may also include other orientations (e.g., rotated 90 degrees or other orientations), and the spatial descriptive terms used herein are interpreted accordingly.

[0023] In the description of this application, the term "for example" is used to mean "used as an example, illustration, or description." Any embodiment described as "for example" in this application is not necessarily to be construed as being more preferred or advantageous than other embodiments. The following description is provided to enable any person skilled in the art to make and use the invention. Details are set forth in the following description for purposes of explanation. It should be understood that those skilled in the art will recognize that the invention can be made without using these specific details. In other instances, well-known structures and processes will not be described in detail to avoid obscuring the description of the invention with unnecessary detail. Therefore, the invention is not intended to be limited to the embodiments shown, but is consistent with the broadest scope of the principles and features disclosed in this application.

[0024] Example 1 like Figures 1 to 5As shown, this embodiment provides a ventricular septal defect (VSD) closure device, including a left ventricular closure disc 1, an expandable body 2, a right ventricular closure disc 3, and an elastic traction rod 4. The elastic traction rod 4 is detachably and fixedly connected to the expandable body 2 for implanting the expandable body 2 into the site of the heart to be closed. The two ends of the expandable body 2, which passes through the site to be closed, are fixedly connected to the left ventricular closure disc 1 and the right ventricular closure disc 3, respectively. The left ventricular closure disc 1 is used to conform to the left ventricle and the interventricular septum, and the right ventricular closure disc 3 is used to conform to the right ventricle and the interventricular septum. The purpose of this embodiment is to systematically solve the pain points of "difficult localization, incomplete closure, and significant damage" in traditional VSD treatment.

[0025] Specifically: The left ventricular occlusion disc 1 and the right ventricular occlusion disc 3 need to have high elasticity and strength to ensure a perfect fit to the ventricular wall and achieve self-adaptation. However, they should not be too soft, making them susceptible to being washed away by blood flow or easily pulled from the left ventricle into the right ventricle during surgery. Therefore, the occlusion discs (left ventricular occlusion disc 1 and right ventricular occlusion disc 3) are generally made of polyester fiber cloth or felt. These discs require a three-dimensional dense weaving process using polyester fibers (a current technology) to provide excellent water resistance, with a water leakage rate ≤300 ml / (cm²·min) and a thickness ranging from 0.15 to 1 mm, preferably 0.3 to 0.5 mm.

[0026] The left ventricular occlusion disc 1 and the right ventricular occlusion disc 3 can also be manufactured using non-woven molding methods, such as casting with a film coating, injection molding, rotational molding, or blow molding. The material used can be silicone rubber or polyurethane. This material itself is completely waterproof, thus providing excellent leak-proof performance. Its hardness ranges from 10 to 80 degrees, with an optimal hardness of 30 to 50 degrees. The thickness generally ranges from 0.2 to 1 mm, preferably 0.4 to 0.6 mm, resulting in excellent self-adaptive fit. The occlusion discs can be square or round, generally round or oval. They can be cut on-site or pre-cut into various sizes and shapes for direct clinical use.

[0027] The left ventricular occlusion disc 1 and the expandable body 2 can be integrated or separate. When integrated, they need to be prefabricated in different sizes in the factory for selection during surgery; the specific dimensions refer to the preset dimensions of expandable body 2. When integrated, the finished product resembles a mushroom head or forms a T-shape. While integrated designs are convenient for immediate use, in actual factories, many specifications are designed and manufactured according to orthogonal tables, leading to increased costs and waste in clinical settings. Therefore, separate designs are preferred. When the left ventricular occlusion disc 1 and expandable body 2 are separate, before surgery, the shape and volume of the defect are measured, appropriate left ventricular occlusion disc 1 and expandable body 2 are selected, and then, according to the location of the defect in the ventricle, the two are sutured together.

[0028] The expandable body 2 can be made of expandable and biodegradable materials, with polyester urethane as a representative. Currently, materials that can absorb liquid and expand include gelatin sponge, chitosan, etc. These self-expanding bodies, as long as they come into contact with a sufficient amount of liquid (whether it is blood, saline, or drug solutions such as heparin), will absorb the liquid through their porous structure and expand. A biodegradable expandable hemostatic cotton is a good reference on the market, with a typical expansion ratio of 5 to 10 times. This creates a three-dimensional network-like loose structure inside, which has a filling effect without excessive compression of surrounding tissues. This structure has good integrity and strong controllability, but its disadvantage is that it cannot completely fill all defects. Moreover, this expandable body must be pre-designed into shapes of different thicknesses and lengths. During use, the volume of the defect and the shape of the pre-filling location are measured first, and then an expandable body of appropriate thickness is selected before implantation. Generally, the thickness of the unexpanded expandable body is 5-15 mm, preferably 8-12 mm, with 1 mm increments for each specification. The length is generally 10-30 mm, typically 15-25 mm. Furthermore, the length can be cut on-site. Generally, the shape of the expansion body 2 is cylindrical, but it can also be a frustum shape.

[0029] The expansion body 2 can also be a thin-walled tube 21, which can be made of silicone material with a thickness of 0.05~0.2mm, preferably 0.1mm. A certain number of small holes 22 can be opened on the tube wall, and a small filling port 23 is reserved after the head end is connected to the ventricular occlusion plate (e.g., Figure 4 As shown), it is generally 1~3mm. Expanding foam, typically implantable medical-grade polyurethane foam (the foam can be expanded polytetrafluoroethylene (ePTFE) or other polyurethane materials), is used to fill the interior (e.g., Figure 5(As shown). The expansion ratio is generally 10-20 times. When the expanding foam is injected into the lumen, it gradually expands and fills the entire defect area. Although the defect is very complex, because the expanded body has a thin-walled structure and is very easily molded, it is shaped into a very complex form as the expanding foam fills, almost filling the entire defect cavity. For very complex defect forms, because of the small holes in the lumen, it can overflow and fill as much of the defect as possible. This branching method ensures that the occluder has almost no risk of displacement, thus perfectly filling the defect. At the same time, polyurethane foam is a very strong adhesive; even if it overflows from the small holes, it maintains excellent overall strength. Using an expanded body allows for maximum adaptation to complex defect shapes without generating excessive compressive force, unlike many self-expanding stent occluders which not only fail to seal the defect but also cause compression deformation of surrounding tissues, thus failing to achieve good results. The advantage of using thin-walled tubing filled with foam material is that it eliminates the need to pre-select the size of the expander. Instead, it allows for precise control of the filling and sealing effect by calculating the required amount of polyurethane based on the volume of the material defect. Generally, the redundancy is designed to be 0-10%, meaning that the expanded volume of the foam is greater than the volume of the defect.

[0030] The elastic traction rod 4 can be a hollow tube or a solid rod. Its diameter ranges from 1 to 10 mm, preferably 2 to 6 mm. It possesses excellent strength and elasticity, allowing it to pass smoothly through various complex cavities and defects. It can be made of silicone rubber with a hardness controlled between 40 and 90 degrees. Alternatively, it can be made of various materials used in the fabrication of interventional catheters, such as PE, PP, PEbax, PTFE, and PU.

[0031] The elastic traction rod 4 can also be made of metal (such as nickel-titanium alloy shape memory material) as a guide wire, or as a sodium hypochlorite tube (the tube wall is laser-perforated). However, its head end must maintain a certain strength for connection with the other end of the expansion body 2.

[0032] The connection between the elastic traction rod 4 and the expansion body 2 can be achieved in many ways. The elastic traction rod 4 can be made without any additional design; simply sew the head end to the assembly. Alternatively, the exposed head end can have a barb or barb structure to directly hook onto the assembly. When the head end has a barb or barb structure, it needs to be wrapped and protected to prevent damage to cardiac tissue or impaired progress as the elastic traction rod 4 travels from the right atrial opening to the left atrial opening.

[0033] Example 2 For diseased heart (e.g.) Figure 6As shown, severe myocardial ischemia leads to severe perforation of the ventricular septum, and the perforation is not in one location and is not a regular channel. Based on the structure of Embodiment 1, this embodiment provides a method for using a ventricular septal defect closure device, including the following steps: S1. Pathway Establishment: An elastic traction rod 4 is inserted through the right atrial fenestration. The elastic traction rod 4 sequentially passes through the tricuspid valve into the right ventricle, through the VSD defect hole into the left ventricle, and finally passes retrogradely through the mitral valve, protruding its tip from the left atrial fenestration (e.g., ...). Figure 7 (as shown) S2. Instrument assembly and connection: The assembly of the left ventricular occlusion disc 1 and the expansion body 2, which were selected before the operation (integrated) or sutured (separate), is connected to the end of the elastic traction rod by means of sutures or barbs. S3. Traction Positioning: Slowly pull the elastic traction rod 4 to pull the assembly to the VSD position and ensure that the left ventricular occlusion plate is tightly attached to the left ventricular wall; S4. Separation and Fixation: After the assembly of the left ventricular occlusion disc 1 and the expansion body 2 is successfully pulled into place by the elastic traction rod 4, disconnect the connection between the elastic traction rod 4 and the assembly (remove the hook or cut the suture), suture the right ventricular occlusion disc 3 and the expansion body 2 together, and ensure that the right ventricular occlusion disc is in close contact with the right ventricular wall (e.g., Figure 8 (as shown) If the expandable body 2 is made of an expandable material, the right ventricular occlusion disc 3 can be directly sutured to the assembly, maintaining a certain pressure on the right ventricle to allow it to deform and fully conform to the right ventricular wall. As blood and tissue fluid are gradually absorbed by the expandable body 2, it can fully fill the ventricular septal defect (e.g., Figure 9 (As shown). Alternatively, when the patient has insufficient blood, after the right ventricular occlusion disc 3 has been initially sutured and fixed (but the sutures have not been fully tightened), normal saline or heparinized water can be injected through the pre-set injection channel (or temporary puncture hole) of the expander 2. The injected volume is 1.2 to 1.5 times the unexpanded volume of the expander. After observing that the expander has filled to be flush with the edge of the defect, the sutures are tightened to complete the fixation, thereby achieving a controllable expansion process.

[0034] If the expansion body 2 is a thin-walled lumen and foam is used for expansion, then when suturing the right ventricular occlusion plate 3 and the expansion body 2, pressure must be maintained while ensuring a certain sealing effect. A seamless seal must be achieved through close-needle overlock sutures to prevent the foam from overflowing into the right ventricle. Specifically, medical non-absorbable sutures can be used, with close-needle overlock sutures of 0.5-0.8 mm stitch spacing and 0.3-0.5 mm edge distance along the contact surface between the expansion body 2 wall and the right ventricular occlusion plate 3. This ensures the suture penetrates the entire thickness of the occlusion plate and the expansion body wall (avoiding puncture of the opposite wall), while avoiding small holes in the wall and leaving a 2-3 mm gap around the filling port. In the seamless area, during suturing, use forceps to gently press the sealing disc to maintain a slight and continuous pressure (to avoid tube wall indentation or wrinkling) to prevent gaps from forming when the foam is filled; after suturing, rinse and check for leakage, then slowly inject medical-grade polyurethane foam through the filling port, and immediately seal the filling port with a purse-string suture after injection; because polyurethane foam can not only fully fill the pores, but it is also a very strong adhesive, and after complete curing, it can bond the left ventricular sealing disc 1 and the right ventricular sealing disc 3 very well, thereby eliminating any risk of detachment and making the overall structure safer and more reliable; S5. Confirm the effect: Check the fit of the sealing disc and the integrity of the expansion body filling to ensure there is no residual shunting and complete the operation.

[0035] While embodiments or examples of this disclosure have been described with reference to the accompanying drawings, it should be understood that the above embodiments are merely exemplary embodiments or examples, and the scope of the invention is not limited by these embodiments or examples, but only by the granted claims and their equivalents. Various elements in the embodiments or examples may be omitted or replaced by their equivalents. Furthermore, the steps may be performed in a different order than that described in this disclosure. Further, various elements in the embodiments or examples may be combined in various ways. Importantly, as the technology evolves, many elements described herein can be replaced by equivalents that appear after this disclosure.

Claims

1. A ventricular septal defect closure device, characterized in that, It includes a left ventricular occlusion disc, an expandable body, a right ventricular occlusion disc, and an elastic traction rod. The elastic traction rod is detachably and fixedly connected to the expandable body for implanting the expandable body into the site to be occluded. The two ends of the expandable body, which passes through the site to be occluded, are fixedly connected to the left ventricular occlusion disc and the right ventricular occlusion disc, respectively. The left ventricular occlusion disc is used to conform to the left ventricle and the interventricular septum, and the right ventricular occlusion disc is used to conform to the right ventricle and the interventricular septum.

2. The ventricular septal defect closure device according to claim 1, characterized in that, Both the left ventricular occlusion disc and the right ventricular occlusion disc are made of high-elasticity, high-strength polyester fiber cloth, which is manufactured by a three-dimensional dense weaving process, with a thickness ranging from 0.15 to 1 mm.

3. The ventricular septal defect closure device according to claim 1, characterized in that, Both the left and right ventricular occlusion discs are made of silicone rubber or polyurethane material and are formed by casting, coating, injection molding, rotational molding or blow molding. The thickness ranges from 0.2 to 1 mm and the hardness ranges from 10 to 80 degrees.

4. The ventricular septal defect closure device according to claim 1, characterized in that, The left ventricular occlusion plate and the right ventricular occlusion plate are square, round or elliptical. The left ventricular occlusion plate and the expansion body are integral or separate structures. When separated, the expansion body and the left ventricular occlusion plate and the right ventricular occlusion plate are fixed by sutures.

5. A ventricular septal defect closure device according to claim 1, characterized in that, The expander is made of expandable and biodegradable polyester urethane material and is cylindrical or frustum-shaped.

6. The ventricular septal defect closure device according to claim 1, characterized in that, The expansion body is made of silicone material and is in the shape of a thin-walled tube with a thickness of 0.05~0.2mm. Small holes are opened on the tube wall. After the head end is connected to the ventricular occlusion plate, a filling port is reserved. The inside is filled with polyurethane foam.

7. The ventricular septal defect closure device according to claim 1, characterized in that, The elastic traction rod is made of any one of the following materials: silicone rubber, PE, PP, PEbax, PTFE, and PU. It has a hollow tube or solid rod structure with a diameter ranging from 1 to 10 mm and is connected to the expansion body by stitching.

8. A ventricular septal defect closure device according to claim 1, characterized in that, The elastic traction rod is made of metal and takes the form of a guide wire or a hysteresis tube. It is connected to the expansion body by a hook.

9. The method of using a ventricular septal defect closure device according to claim 1, characterized in that, Includes the following steps: S1. Path establishment: An elastic traction rod is inserted from the right atrial fenestration. The elastic traction rod passes through the tricuspid valve into the right ventricle, passes through the VSD defect hole into the left ventricle, and finally passes through the mitral valve in reverse and protrudes from the left atrial fenestration. S2. Instrument assembly and connection: The assembly of the left ventricular occlusion disc and the expansion body selected or sutured before the operation is connected to the end of the elastic traction rod by means of sutures or barbs. S3. Traction Positioning: Slowly pull the elastic traction rod to pull the assembly to the VSD position and ensure that the left ventricular occlusion disc fits tightly against the left ventricular wall; S4. Separation and Fixation: Disconnect the elastic traction rod from the assembly, suture the right ventricular occlusion disc to the expansion body, and ensure that the right ventricular occlusion disc fits against the right ventricular wall. S5. Confirm the effect: Check the fit of the sealing disc and the integrity of the expansion body filling to ensure there is no residual shunting and complete the operation.

10. The method of using a ventricular septal defect closure device according to claim 9, characterized in that, If the expandable body is made of expandable material, the right ventricular occlusion disc can be directly sutured to the assembly. The expandable body expands and fills the defect in the ventricular septum by absorbing blood and tissue fluid. Alternatively, the expandable body can be stimulated to fully expand by injecting saline or heparin. If the expander is a foam-type expander, the right ventricular occlusion plate and the assembly need to be stitched together with dense needles to ensure that the foam does not overflow into the right ventricle. At the same time, the small holes in the expandable tube wall should be avoided during stitching. The expander is filled and expanded by injecting polyurethane foam.

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