Dual-disk integrally formed heart occluder

Abstract

The application discloses a double-disc integrally-formed heart occluder, a first disc part, a second disc part and an occlusion part are integrally formed, the first disc part, the second disc part and the occlusion part are all degradable members, the first disc part, the second disc part and the occlusion part are all configured as elastic members, at least the first disc part is configured as a hollow structure, the first disc part and the second disc part are adapted to switch between a storage state and a deployed state, in the storage state, the first disc part and the second disc part are stretched away from each other along the axial direction of the occlusion part to be contracted, in the deployed state, the first disc part and the second disc part are stretched along the radial direction of the occlusion part to be disc-shaped. Thus, all the shortcomings of the existing woven structure occluder can be overcome, and the surgical operation can be simplified, the first disc part is a hollow structure, can have better elasticity, higher flexibility, is beneficial to the first disc part to fit the surrounding profile, and improves the stress distribution uniformity, improves the limiting effect on the occlusion part, and improves the stability and reliability of the heart occluder.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a dual-disc, one-piece molded cardiac occluder. Background Technology

[0002] Atrial septal defect (ASD) is a hole in the septum between two atria, accounting for about 7-10% of all congenital heart diseases. Depending on the location, it can be divided into: secundum ASD (80%): the defect is located in the middle of the atrial septum, hence also called central secundum ASD; primum ASD (10%): located near the mitral and tricuspid valve annulus, it may cause mitral valve cleft and insufficiency, and in a sense is equivalent to "partial endocardial septal defect"; sinus venosus ASD (10%): can be divided into superior vena cava (close to the superior vena cava entrance, often accompanied by right pulmonary vein drainage abnormalities) and inferior vena cava (located lower, connected to the inferior vena cava opening); patent foramen ovale (PFO): generally considered a type of ASD, it usually closes spontaneously within a few months after birth.

[0003] The foramen ovale is a physiological passage in the atrial septum during embryonic development. Around 5-7 months after birth, in most individuals, the secondary and primary septa of the atrial septum adhere and fuse to form a permanent atrial septum. If fusion fails, a patent foramen ovale (PFO) is formed. Because the shunt volume of the PFO is so small, it was long believed that PFO would not cause clinical consequences. In recent years, however, increasing research has found that patients with PFO have a significantly higher risk of stroke, migraine, peripheral artery embolism, and decompression sickness compared to the general population. This has drawn the attention of experts and scholars to the pathogenic effects of PFO, leading to clinical explorations using methods such as PFO closure to prevent recurrent stroke events and treat migraines and recumbent-orthostatic hypoxemia.

[0004] Ventricular septal defect (VSD) is a common congenital heart disease. The opening in the ventricular septum between the left and right ventricles is called a ventricular septal defect. VSDs primarily form during fetal development. In patients with VSDs, blood typically flows from the left ventricle into the right ventricle through the defect, increasing the blood volume in the right ventricle. The long-term presence of a VSD can cause pulmonary hypertension, congestive heart failure, palpitations, shortness of breath, fatigue, and recurrent lung infections.

[0005] Among related technologies, minimally invasive interventional treatments for heart defects such as atrial septal defects, patent foramen ovale, and ventricular septal defects are now very mature. Compared to traditional surgery, minimally invasive interventional treatment is a modern, high-tech, minimally invasive procedure. Through femoral vein puncture, guided by medical imaging equipment, a guide wire is inserted along the femoral vein and inferior vena cava until it reaches the affected area. Finally, a cardiac occluder is pushed into the delivery catheter to the atrial or ventricular septal defect site for closure. The cardiac occluder is like an umbrella in everyday life; it is folded up when inserted and unfolds after being positioned at the defect site to close it, achieving the therapeutic goal. This minimally invasive interventional treatment has advantages such as no incision, minimal trauma, fewer complications, faster recovery, better results, a wider range of indications, and relatively lower surgical costs.

[0006] However, since the main stent of the cardiac occluder currently used in clinical practice is mainly made of nickel-titanium alloy wire, since this type of metal material cannot be degraded in the human body, long-term implantation will cause inflammation, coagulation and other reactions with human tissues, or even a certain degree of damage, so there are certain defects. It may still have the following risks: (1) Nickel-titanium alloy is a non-degradable metal alloy material. Although its biocompatibility has been demonstrated, the long-term risks of long-term permanent implantation cannot be completely controlled; (2) Since nickel-titanium alloy is permanently implanted and non-degradable, there is a lack of long-term follow-up data on the safety of permanent heart implantation and the impact of fixed-size cardiac occluders on the continuously growing and developing heart of children. It may affect the development and growth of the heart of patients who have not yet matured; (3) There is still no clear scientific evidence for complications such as nickel precipitation and nickel allergy.

[0007] Once the surface of the cardiac occluder is completely endothelialized and the heart defect is repaired by the body's own tissues, there is absolutely no need for the cardiac occluder to remain in the body. Therefore, an ideal cardiac occluder should provide a temporary bridge for the heart's own repair process, allowing the body's own cells and tissues to climb and grow, and then be degraded by the body after fulfilling its function, so that the defect can be completely repaired by the body's own tissues, thereby avoiding the long-term complications and safety hazards caused by metal remaining in the body.

[0008] Currently, the occluders widely used in clinical practice are woven metal-nonwoven occluders that have been gradually optimized based on the Amplatzer occluder. The materials are mostly nickel-titanium alloys or other metals and non-degradable nonwoven fabrics. Not only do they lack biodegradability and need to remain permanently in the human body, but they also have unavoidable drawbacks such as excessive stress, metal corrosion, and nickel poisoning. Summary of the Invention

[0009] This invention aims to solve at least one of the technical problems existing in the prior art. Therefore, the purpose of this invention is to propose a dual-disc, one-piece molded cardiac occluder, using biodegradable components, with at least the first disc having a hollow structure. This not only avoids long-term complications and safety hazards caused by metal remaining in the body, but also provides better elastic deformation capacity of the first disc, resulting in better occlusion and easier insertion.

[0010] This application provides a dual-disc integrally formed cardiac occluder, comprising: a first disc portion, a second disc portion, and an occlusion portion, wherein the first disc portion and the second disc portion are connected to the two axial ends of the occlusion portion, the first disc portion, the second disc portion, and the occlusion portion are integrally formed, and the first disc portion, the second disc portion, and the occlusion portion are all biodegradable components; The first disc portion, the second disc portion, and the sealing portion are all constructed as elastic elements. At least the first disc portion is constructed as a hollow structure. The first disc portion and the second disc portion are adapted to switch between a retracted state and an extended state. In the retracted state, the first disc portion and the second disc portion extend away from each other along the axial direction of the sealing portion to retract. In the extended state, the first disc portion and the second disc portion extend radially along the sealing portion to form a disc shape.

[0011] According to an embodiment of the present invention, the cardiac occluder is a one-piece biodegradable component. The cardiac occluder provides a temporary bridge for the heart's self-repair, allowing its own cells and tissues to climb and grow, subsequently being degraded and absorbed within the body. This avoids long-term complications and safety hazards caused by metal residue in the body. The cardiac occluder has strong structural integrity, overcoming all the shortcomings of existing woven occluders, and also simplifies surgical procedures. The first disc portion has a hollow structure, allowing for a thinner thickness and better elasticity and flexibility. This also facilitates the first disc portion's fit to the surrounding surface, improves the uniformity of force distribution, enhances the limiting effect on the occlusion portion, and improves the stability and reliability of the cardiac occluder.

[0012] According to some embodiments of this application, in the unfolded state, the first disc portion includes: a first wall, a second wall, and a third wall. The first wall and the second wall are axially opposite each other. The radially inner edge of the first wall is connected to the sealing portion. The second wall or the first wall defines a closed surface. The radially outer edges of the first wall and the second wall are respectively connected to the axial end edges of the third wall and define a first cavity, so that in the retracted state, the radially inner sides of the first wall and the second wall adjacent to the sealing portion are moved away from each other.

[0013] According to some embodiments of this application, a first radial rib is provided between the first wall and the sealing portion.

[0014] According to some embodiments of this application, the sealing part is constructed as a solid component, one end of the sealing part is connected to the first wall, and the other end of the sealing part is connected to the second disc part.

[0015] According to some embodiments of this application, the sealing part is constructed as a hollow structure, the sealing part has an annular wall, the two axial ends of the annular wall are respectively connected to the first disk part and the second disk part, and the annular wall defines a second cavity that communicates with the first cavity.

[0016] According to some embodiments of this application, at least one axially extending expansion groove is provided on the annular wall.

[0017] According to some embodiments of this application, the second disc portion is constructed as a solid part.

[0018] According to some embodiments of this application, the second disc portion is constructed as a hollow structure. In the unfolded state, the second disc portion includes a fourth wall, a fifth wall, and a sixth wall. The fourth wall and the fifth wall are axially opposite each other. The radially inner edge of the fourth wall is connected to the sealing portion. The fifth wall or the fourth wall defines a closed surface. The radially outer edges of the fourth wall and the fifth wall are respectively connected to the axial ends of the sixth wall and define a third cavity, so that in the retracted state, the radially inner sides of the fourth wall and the fifth wall adjacent to the sealing portion are moved away from each other.

[0019] According to some embodiments of this application, a second radial rib is provided between the second disc portion and the sealing portion, or on the side of the second disc portion away from the sealing portion.

[0020] According to some embodiments of this application, the first disc portion, the second disc portion, and the sealing portion are all constructed as hollow structures, and the first cavity of the first disc portion, the second cavity of the sealing portion, and the third cavity of the second disc portion are connected.

[0021] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0022] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which: Figure 1 This is a perspective view of a cardiac occluder according to the first embodiment of this application; Figure 2 This is a schematic diagram of a cardiac occluder according to the first embodiment of this application at one angle; Figure 3 This is a schematic diagram of the cardiac occluder according to the first embodiment of this application from another angle; Figure 4 This is a perspective view of a cardiac occluder according to the second embodiment of this application; Figure 5 This is a schematic diagram of a cardiac occluder according to a second embodiment of this application at one angle; Figure 6 This is a schematic diagram of the cardiac occluder according to the second embodiment of this application from another angle.

[0023] Figure label: Heart occluder 100 First plate section 10, first wall 11, second wall 12, third wall 13 Sealing part 20, expansion groove 21, Second section 30, fourth wall 31, fifth wall 32, sixth wall 33 Connecting part 40, First radial rib a, second radial rib b Axial direction X, radial direction Y. Detailed Implementation

[0024] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, 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.

[0025] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the terminology used in the description of this application is for the purpose of describing particular embodiments only and is not intended to limit the application; the terms "comprising" and "having," and any variations thereof, in the description, claims, and accompanying drawings of this application are intended to cover non-exclusive inclusion. The terms "first," "second," etc., in the description, claims, or accompanying drawings of this application are used to distinguish different objects, not to describe a specific order or hierarchy.

[0026] In this application, the reference to "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment that is mutually exclusive with other embodiments.

[0027] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "attachment" 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 direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0028] In this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Additionally, in this application, the character " / " generally indicates that the preceding and following related objects have an "or" relationship.

[0029] In the embodiments of this application, the same reference numerals denote the same components, and for the sake of brevity, detailed descriptions of the same components are omitted in different embodiments. It should be understood that the thickness, length, width, and other dimensions of various components in the embodiments of this application shown in the accompanying drawings, as well as the overall thickness, length, width, and other dimensions of the integrated device, are merely illustrative and should not constitute any limitation on this application.

[0030] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0031] In the description of this invention, the first feature being "above" or "below" the second feature may include the first and second features being in direct contact, or it may include the first and second features not being in direct contact but being in contact through another feature between them.

[0032] In the description of this invention, the terms "above," "over," and "on top" for the first feature and the second feature include the first feature being directly above or diagonally above the second feature, or simply indicating that the first feature is at a higher horizontal level than the second feature.

[0033] In this application, "multiple" means two or more (including two).

[0034] The following is for reference. Figures 1-6A cardiac occluder 100 according to an embodiment of the present invention is described.

[0035] like Figures 1-6 As shown, this application provides a dual-disc integrally formed cardiac occluder 100, including: a first disc portion 10, a second disc portion 30, and an occlusion portion 20.

[0036] The first disc portion 10 and the second disc portion 30 are connected to the two ends of the sealing portion 20 in the axial direction. The sealing portion 20 is used to seal the structure to be sealed. The structure to be sealed can be a through hole formed in human tissue, such as the aforementioned atrial septal defect, ventricular septal defect, patent foramen ovale defect, etc. Of course, it can also be other defect structures in human tissue, such as vascular defects. The first disc portion 10 and the second disc portion 30 can push against human tissue on both sides of the through hole to achieve the sealing of the through hole.

[0037] It should be noted that the first disc 10, the second disc 30, and the sealing part 20 are integrally formed, and the first disc 10, the second disc 30, and the sealing part 20 are all biodegradable parts.

[0038] Specifically, the first disc 10, the second disc 30, and the sealing part 20 can all be constructed as at least one of biodegradable polymer material, biodegradable metal material, bioceramic material, and bioglass material. The integral molding of the first disc 10, the second disc 30, and the sealing part 20 means that the three are molded simultaneously to improve the reliability and stability of the connection between the three, improve the sealing effect on the through hole, and reduce the processing difficulty. The integral molding of the three can be made of the same structural material or different structural material. This application does not make a specific limitation.

[0039] Understandably, the cardiac occluder 100 is a biodegradable component, which can be degraded and absorbed in the body within 6 months to 2 years after surgery. The cardiac occluder 100 provides a temporary bridge for the heart's own repair, allowing its own cells and tissues to climb and grow. After fulfilling its mission, it is degraded by the body, so that the perforation can be completely repaired by its own tissues, avoiding the impact of the cardiac occluder 100 being permanently retained in the human body, and will not affect future surgical treatment for possible heart diseases.

[0040] The cardiac occluder 100 of the present invention is a one-piece biodegradable component. Compared with the cardiac occluder 100 in the related technology, which uses nickel-titanium alloy metal wires to weave a mesh frame and then cover it with a flow-blocking membrane, the cardiac occluder 100 of the present invention can avoid long-term complications and safety hazards caused by metal remaining in the body. In addition, the cardiac occluder 100 of the present invention has a one-piece structure with strong structural integrity, which can overcome all the disadvantages of the traditional woven cardiac occluder 100 and also simplify the surgical operation.

[0041] The cardiac occluder 100 can be formed from the same material, with a uniform degradation rate in the human body and no risk of structural disintegration. Alternatively, the cardiac occluder 100 can be integrally formed from different materials. For example, the first disc portion 10 and the second disc portion 30 can be made of materials with faster degradation rates, so that the first disc portion 10 and the second disc portion 30 can be preferentially degraded during the myocardial tissue repair process, while the repair process of the through-hole area is slower. Correspondingly, the occlusion portion 20 with a slower degradation rate can be used to provide a reliable occlusion effect.

[0042] The first disc portion 10, the second disc portion 30, and the sealing portion 20 are all constructed as elastic elements, so that the first disc portion 10, the second disc portion 30, and the sealing portion 20 are all constructed to be elastically deformable and can automatically return to their original shape.

[0043] Specifically, at least the first disc portion 10 is constructed as a hollow structure, and the first disc portion 10 and the second disc portion 30 are adapted to switch between a retracted state and an extended state. In the retracted state, the first disc portion 10 and the second disc portion 30 extend away from each other along the axial direction of the sealing portion 20 to retract. In the extended state, the first disc portion 10 and the second disc portion 30 extend radially along the sealing portion 20 to form a disc shape.

[0044] Understandably, in the retracted state, the first disc 10 and the second disc 30 extend away from each other along the axial direction of the sealing part 20 to contract, so that during the process of the first disc 10 and the second disc 30 changing from the retracted state to the unfolded state, they both elastically deform toward the sealing part 20 to push against both sides of the through hole, which can have a better positioning effect on the sealing part 20.

[0045] Furthermore, the first disc portion 10 is constructed as a hollow structure, and the wall thickness of the hollow first disc portion 10 can be set to be thinner, so that the first disc portion 10 of the integrally formed heart occluder 100 can have higher elasticity, and during the occlusion process, the hollow first disc portion 10 can provide a more uniform pushing and limiting force. At the same time, the first disc portion 10 is more flexible and can fill the uneven surface of the surrounding area through the deformation of its own hollow area, so as to make the fit of the first disc portion 10 better.

[0046] The cardiac occluder 100 used in interventional treatment needs to be introduced to the lesion site through a thin sheath. The cardiac occluder 100 of the present invention can deform to reduce its volume so that it can be stored in the sheath for easy delivery. After the cardiac occluder 100 is delivered from the sheath, it can automatically return to its original shape to seal the through hole.

[0047] The following is a brief description of the occlusion process using the cardiac occluder 100 of this invention. When using the cardiac occluder 100 of this invention, the sheath is extended to the through-hole area, and the pushing component pushes the cardiac occluder 100 along the sheath to the through-hole. The second disc 30 is released from the sheath on one side of the through-hole. After the second disc 30 is released, it automatically returns to its original state and abuts against the inner wall of the myocardial tissue on one side of the through-hole. Then, the occlusion part 20 is released from the sheath and positioned inside the through-hole to seal the defect. Finally, the first disc 10 is released from the sheath on the other side of the through-hole. After the first disc 10 is released, it automatically returns to its original state and abuts against the inner wall of the myocardial tissue on the other side of the through-hole, thereby achieving the sealing of the defect by the cardiac occluder 100.

[0048] In addition, compared to the cardiac occluder 100 in related technologies that uses a mesh frame woven from nickel-titanium alloy wires and covered with a flow-blocking membrane, the cardiac occluder 100 in this embodiment of the invention is an elastic element, rather than being formed by metal weaving. The cardiac occluder 100 can deform into a smaller volume, thus allowing delivery through a smaller diameter sheath, which helps reduce surgical risks. When the cardiac occluder 100 is withdrawn from the sheath, it automatically returns to its original shape. Therefore, there is no need for an additional drive mechanism to restore the cardiac occluder 100 to its original shape, reducing manufacturing costs and simplifying operation.

[0049] According to an embodiment of the present invention, the cardiac occluder 100 is an integrally molded biodegradable component. The cardiac occluder 100 provides a temporary bridge for the heart's self-repair, allowing its own cells and tissues to climb and grow, subsequently being degraded and absorbed within the body. This avoids long-term complications and safety hazards caused by metal remaining in the body. The cardiac occluder 100 has strong structural integrity, overcoming all the shortcomings of existing woven occluders, and also simplifies surgical procedures. The first disc portion 10 has a hollow structure, allowing for a thinner thickness and better elasticity and flexibility. This also facilitates the first disc portion 10's fit against surrounding surfaces, improves the uniformity of force distribution, enhances the limiting effect on the occlusion portion 20, and improves the stability and reliability of the cardiac occluder 100.

[0050] Combination Figure 2 , Figure 3 , Figure 5 and Figure 6As shown, according to some embodiments of this application, in the unfolded state, the first disc portion 10 includes: a first wall 11, a second wall 12, and a third wall 13. The first wall 11 and the second wall 12 are arranged opposite each other in the axial direction. The radial inner edge of the first wall 11 is connected to the sealing portion 20. The second wall 12 or the first wall 11 defines a closed surface. The radial outer edges of the first wall 11 and the second wall 12 are respectively connected to the axial end edges of the third wall 13 and define a first cavity so that in the retracted state, the radial inner sides of the first wall 11 and the second wall 12 adjacent to the sealing portion 20 are moved away from each other in the axial direction.

[0051] Specifically, the second wall 12 or the first wall 11 defines a closed surface. When the projection of the sealing part 20 along the axial direction is superimposed, the overlapping area is a closed area after the projection contours of the first wall 11 and the second wall 12 coincide. This ensures that the first disc part 10 can fit with the surrounding surface, improving the limiting effect on the sealing part 20 while also providing better shielding. This enhances the sealing effect of the cardiac occluder 100 on the structure to be sealed and reduces the occurrence of peripheral gap overflow.

[0052] The first wall 11 and the second wall 12 are arranged opposite each other along the axial direction, and the third wall 13 connects the radial outer edges of the first wall 11 and the second wall 12, thereby defining a cavity (i.e., the first cavity).

[0053] In this way, by setting the first cavity, on the one hand, the thickness of the first wall 11 and the second wall 12 can be set to be thinner, which not only facilitates the climbing and growth of surrounding cells and tissues and improves the repair effect, but also the first wall 11 and the second wall 12 can be supported by the third wall 13. The third wall 13 can evenly distribute the force through its own elastic deformation, which can improve the fixation stability and reliability of the cardiac occluder 100. On the other hand, it can reduce the deformation difficulty of the first disc 10, making it easier to switch between the unfolded state and the retracted state. During the retraction process, the first wall 11 can extend and retract away from the occlusion part 20 along the axial direction. During the retraction process of the third wall 13, it can simultaneously drive the second wall 12 away from the first wall 11 and retract. The connecting part 40 is set at the axial center position on the side of the second wall 12 away from the first wall 11. During the movement of the first disc 10 through the connecting part 40, the overall movement synchronization of the first disc 10 is better. In the retracted state, the axial projection profile of the first disc 10 is smaller, which can also reduce the difficulty of pushing the cardiac occluder 100.

[0054] More importantly, the design of the first cavity allows for better fit between the first wall 11 and the surrounding surfaces, reducing gap areas and thus lowering the risk of local thrombosis. It also facilitates the climbing of surrounding cells and tissues, allowing the through hole to be repaired by its own tissue more quickly and reducing healing time.

[0055] like Figure 4 and Figure 5 As shown, according to some embodiments of this application, a first radial rib a is provided between the first wall 11 and the sealing part 20.

[0056] Specifically, the first radial rib a can be 2, 4, 5, 6, 8, 10, 20, 50, 100, etc., and can be adaptively set based on the elastic force requirements of the first disc 10. Preferably, the first radial rib a is 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0057] The first radial rib a is arranged around the occlusion part 20 in the circumferential direction and extends to the first wall 11. It extends radially on the first wall 11. By setting the first radial rib a, not only can the structural strength of the first disc part 10 be improved, thereby improving the overall structural strength of the cardiac occluder 100, but the first radial rib a can also make the connection reliability and stability between the first disc part 10 and the occlusion part 20 higher, and can improve the elastic reset capability of the first disc part 10, which is conducive to the rapid reset of the first disc part 10.

[0058] In some embodiments, the first radial rib a may be disposed on the side surface of the first wall 11 facing the sealing part 20, or on the side surface of the first wall 11 away from the sealing part 20.

[0059] In addition, the portion of the first radial rib a located on the sealing part 20 can increase the contact area between the sealing part 20 and the through hole. This not only improves the sealing effect of the sealing part 20 on the through hole, but also increases the contact area with the surrounding cells and tissues, further improving the stability of the arrangement. It also facilitates the climbing and growth of the surrounding cells and tissues, thus improving the repair effect.

[0060] It should be noted that the sealing part 20 can be cylindrical, and the diameter of the sealing part 20 can be reasonably set according to the diameter of the structure to be sealed. The sealing part 20 can also be adaptively set according to the projection contour of the structure to be sealed on the axial direction of the sealing part 20, such as making the cross-sectional contour of the sealing part 20 hexagonal, racetrack-shaped, elliptical, etc.

[0061] like Figure 4 , Figure 5 and Figure 6 As shown, in some embodiments, the sealing part 20 is constructed as a solid part, with one end of the sealing part 20 connected to the first wall 11 and the other end of the sealing part 20 connected to the second disc part 30.

[0062] In this way, by setting a solid sealing part 20, the sealing part 20 itself has higher structural rigidity, which can improve the sealing effect and improve the structural strength and stability of the heart occluder 100.

[0063] like Figure 1 , Figure 2 and Figure 3 As shown, the structure of the sealing part 20 in this application embodiment is not limited to a solid structure. In other embodiments, the sealing part 20 is constructed as a hollow structure. The sealing part 20 has an annular wall. The two axial ends of the annular wall are connected to the first disk part 10 and the second disk part 30, respectively. The annular wall defines a second cavity that communicates with the first cavity.

[0064] In this way, by setting the annular wall, on the one hand, the thickness of the occlusion part 20 can be reduced, which not only improves the elasticity of the occlusion part 20, but also allows the occlusion part 20 to deform elastically as a whole, thereby reducing its own diameter and extending its own length, making it easier to house in the sheath. Moreover, after the occlusion part 20 extends out of the sheath, it can use its own greater elastic force to allow the first disc part 10 and the second disc part 30 to push against the surrounding cells and tissues at both ends of the occlusion part 20 with greater elastic force, thereby improving the fixation effect of the cardiac occluder 100. At the same time, the outer diameter of the occluder itself after switching to the deployed state can be larger, and the occlusion effect can also be better.

[0065] It is understood that a first radial rib a can be provided on the outer periphery of the annular wall, and radial ribs can also be further provided on the inner wall of the annular wall. Alternatively, the first radial rib a may include a first part located on the inner wall of the annular wall and a second part located on the outer wall of the annular wall, and at least one of the first part and the second part may extend to the first wall 11.

[0066] like Figure 3 As shown, according to some embodiments of this application, at least one axially extending expansion groove 21 is provided on the annular wall.

[0067] Specifically, in embodiments where the sealing part 20 has a hollow structure and a second chamber, at least one axially extending expansion groove 21 can be provided on the annular wall, such as multiple expansion grooves 21, which are spaced at equal angles along the circumference.

[0068] In this way, on the one hand, by setting the expansion groove 21, stress can be released during the deformation of the sealing part 20, and the internal and external pressures of the sealing part 20 can be balanced to achieve pressure balance, so that the sealing part 20 can be quickly switched to the unfolded state, reducing the difficulty of sealing. On the other hand, in the embodiment where the heart occluder 100 is injection molded, the expansion groove 21 can be used for demolding of the heart occluder 100, which can also reduce the processing difficulty.

[0069] like Figure 4 , Figure 5 and Figure 6 As shown, according to some embodiments of this application, the second disc portion 30 is constructed as a solid part.

[0070] Specifically, the second disc portion 30 can be a disc structure with both the side facing the sealing portion 20 and the side away from the sealing portion 20 being flat. Alternatively, the second disc portion 30 can be a conical disc structure with an arc surface on the side facing the sealing portion 20, or a conical disc structure with an arc surface on the side away from the sealing portion 20, so that the second disc portion 30 is constructed as an umbrella-shaped structure extending towards or away from the sealing portion 20 in the unfolded state.

[0071] In this way, the contact area between the second disc portion 30 and the surrounding cells and tissues can be increased. While improving the fixation stability of the cardiac occluder 100 through the second disc portion 30, it can also make the second disc portion 30 more conducive to the climbing and growth of surrounding cells and tissues, thereby further improving the repair effect and repair speed.

[0072] It should be noted that the first disc portion 10 and the second disc portion 30 of the cardiac occluder 100 in this embodiment can also be partially trimmed so that the first disc portion 10 and the second disc portion 30 can better fit the surrounding surface of the structure to be occluded. Since the cardiac occluder 100 is an integrally formed structure, the partial trimming of the first disc portion 10 and the second disc portion 30 will not affect the overall structure of the cardiac occluder 100. The first disc portion 10 and the second disc portion 30 can still perform the limiting and occlusion functions. Therefore, the cardiac occluder 100 of the present invention can support custom trimming, and the cardiac occluder 100 has a wider range of applications, better targeting, and is conducive to improving the repair effect. It can also improve versatility, thereby saving the manufacturing cost of customized parts.

[0073] It should be noted that, in the unfolded state, the axial projected area of ​​the first disc 10 and the second disc 30 should be greater than the projected area of ​​the sealing part 20, and can be reasonably set according to the size of the structure to be sealed.

[0074] For example, in some embodiments of the present invention, the projected areas of the first disc portion 10 and the second disc portion 30 in the axial direction of the sealing portion 20 are each independently 3 mm. 2 -2000mm 2 .

[0075] Optionally, the projected area of ​​the first disc portion 10 in the axial direction of the sealing portion 20 can be 5 mm². 2 55mm 2 100mm 2 300mm 2 900mm 2 1000mm 2 (625*π)mm 2 2000mm 2 wait.

[0076] Optionally, the projected area of ​​the second disc portion 30 in the axial direction of the sealing portion 20 can be 5mm². 2 55mm 2 100mm 2 300mm 2 900mm 2 1000mm 2 (625*π)mm 2 2000mm 2 wait.

[0077] In embodiments where the second disc portion 30 is constructed as a solid part, the thickness of the second disc portion 30 can be 0.01mm-8mm.

[0078] Optionally, the thickness of the second disc portion 30 can be 0.01mm, 0.05mm, 0.1mm, 0.4mm, 0.46mm, 0.5mm, 1mm, 8mm, etc.

[0079] It is worth noting that both the first disc portion 10 and the second disc portion 30 are constructed as disc-shaped structures. Compared to the three-dimensional occluders in related technologies that utilize nickel-titanium alloy wires woven into a mesh frame and then covered with a flow-blocking membrane (non-woven fabric), the cardiac occluder 100 of the present invention has a smaller spatial volume. The cardiac occluder 100 can be deformed into a smaller volume and housed within a sheath, allowing for delivery through a smaller diameter sheath, which helps reduce surgical risks. Furthermore, the first disc portion 10 and the second disc portion 30 can be adapted for cutting, while existing occluders, made of metal braiding, are elastic and cannot be cut, resulting in poorer adaptability compared to this application.

[0080] like Figure 1 , Figure 2 and Figure 3 As shown, according to some embodiments of this application, the second disc portion 30 is constructed as a hollow structure. In the unfolded state, the second disc portion 30 includes a fourth wall 31, a fifth wall 32, and a sixth wall 33. The fourth wall 31 and the fifth wall 32 are arranged opposite each other in the axial direction. The radially inner edge of the fourth wall 31 is connected to the sealing portion 20. The fifth wall 32 or the fourth wall 31 defines a closed surface. The radially outer edges of the fourth wall 31 and the fifth wall 32 are respectively connected to the axial end edges of the sixth wall 33, defining a third cavity so that in the retracted state, the radially inner sides of the fourth wall 31 and the fifth wall 32 adjacent to the sealing portion 20 are moved away from each other in the axial direction.

[0081] Specifically, the fifth wall 32 or the fourth wall 31 defines a closed surface. When the projection of the sealing part 20 along the axial direction is superimposed, the projection contours of the fourth wall 31 and the fifth wall 32 coincide, and the overlapping area is a closed area. This ensures that the second disc part 30 can fit with the surrounding surface, improving the limiting effect on the sealing part 20 while also providing better shielding. This enhances the sealing effect of the cardiac occluder 100 on the structure to be sealed and reduces the occurrence of peripheral gap overflow.

[0082] The fourth wall 31 and the fifth wall 32 are arranged opposite each other along the axial direction, and the sixth wall 33 connects the radial outer edges of the fourth wall 31 and the fifth wall 32, thereby defining a cavity (i.e., the third cavity).

[0083] In this way, by setting a third cavity, on the one hand, the thickness of the fourth wall 31 and the fifth wall 32 can be set to be thinner, which not only facilitates the climbing and growth of surrounding cells and tissues and improves the repair effect, but also allows the fourth wall 31 and the fifth wall 32 to be supported by the sixth wall 33. The sixth wall 33 can evenly distribute the force through its own elastic deformation, which can improve the fixation stability and reliability of the cardiac occluder 100. On the other hand, it can reduce the deformation difficulty of the second disc 30, making it easier to switch between the unfolded state and the retracted state. During the retraction process, the fourth wall 31 can extend away from the occlusion part 20 along the axial direction. During the retraction process of the sixth wall 33, it can simultaneously drive the fifth wall 32 away from the fourth wall 31 for retraction. The overall movement synchronization of the second disc 30 is better. In the retracted state, the axial projection profile of the second disc 30 is smaller, which can also reduce the difficulty of pushing the cardiac occluder 100.

[0084] More importantly, the third cavity allows for better fit between the fourth wall 31 and the surrounding surfaces, reducing gap areas and thus lowering the risk of local thrombosis. It also facilitates the climbing of surrounding cells and tissues, allowing the perforation to be repaired by the tissue itself more quickly and reducing healing time.

[0085] Combination Figure 5 and Figure 6 As shown, according to some embodiments of this application, a second radial rib b is provided between the second disc portion 30 and the blocking portion 20, or on the side of the second disc portion 30 away from the blocking portion 20.

[0086] The second radial rib b can be 2, 4, 5, 6, 8, 10, 20, 50, 100, etc., and can be adapted to the elastic force requirements of the second disc 30. Preferably, the second radial rib b is 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0087] Therefore, the second radial rib b is arranged circumferentially around the sealing part 20 and extends to the second disc part 30 (if the second disc part 30 is a hollow structure, it extends to the fourth wall 31; if the second disc part 30 is a solid part, it extends to the surface of the second disc part 30 facing the sealing part 20). It extends radially on the second disc part 30. By setting the second radial rib b, not only can the structural strength of the second disc part 30 be improved, thereby improving the overall structural strength of the cardiac occluder 100, but the second radial rib b can also make the connection reliability and stability between the second disc part 30 and the sealing part 20 more reliable and stable, and can improve the elastic reset capability of the second disc part 30, which is conducive to the rapid reset of the second disc part 30.

[0088] In some embodiments, the second radial rib b may be disposed on the surface of the second disc portion 30 facing the sealing portion 20; in other embodiments, the second radial rib b may be disposed on both sides of the second disc portion 30 (in combination with...). Figure 5 and Figure 6 As shown), the second radial rib b located on the side of the second disc portion 30 facing the sealing portion 20 extends to the sealing portion 20. In embodiments where the second disc portion 30 is a hollow structure, the second radial rib b can also be provided inside the third cavity.

[0089] In addition, the portion of the second radial rib b located on the sealing part 20 can increase the contact area between the sealing part 20 and the through hole. This not only improves the sealing effect of the sealing part 20 on the through hole, but also increases the contact area with the surrounding cells and tissues, further improving the stability of the arrangement. It also facilitates the climbing and growth of the surrounding cells and tissues, thus improving the repair effect.

[0090] Combination Figure 1 , Figure 2 and Figure 3 As shown, according to some embodiments of this application, the first disc portion 10, the second disc portion 30, and the sealing portion 20 are all constructed as hollow structures, and the first cavity of the first disc portion 10, the second cavity of the sealing portion 20, and the third cavity of the second disc portion 30 are connected.

[0091] In other words, when the first disc 10, the second disc 30, and the sealing part 20 are all constructed as hollow structures, the first chamber, the second chamber, and the third chamber are interconnected.

[0092] This not only makes the heart occluder 100 more elastic and easier to switch between the deployed and retracted states, but also achieves pressure balance between the first, second, and third chambers, making the deformation process of the heart occluder 100 smoother and faster.

[0093] Understandably, when the first disc 10, the second disc 30, and the sealing part 20 are all constructed as hollow structures, when the cardiac occluder 100 is in the retracted state, the connecting part 40, the second wall 12, the third wall 13, the first wall 11, the annular wall, the fourth wall 31, the fifth wall 32, and the sixth wall 33 are arranged in sequence to form a straight structure. In the retracted state, the wall thickness is more consistent, which not only reduces the difficulty of pushing but also makes it easier to switch to the retracted state.

[0094] It should be noted that the axial projection contours of the first disk 10 and the second disk 30 can be circular, hexagonal, racetrack-shaped, triangular, or other structures, and the first disk 10 and the second disk 30 can be locally trimmed based on the required shape.

[0095] In some embodiments of the present invention, the first disc portion 10, the second disc portion 30, and the sealing portion 20 are coaxial, or their axes are parallel. The first disc portion 10 and the second disc portion 30 are at least partially facing each other. After the sealing portion 20 passes through the structure to be sealed, the first disc portion 10 and the second disc portion 30 are sandwiched between the axial sides of the structure to be sealed, resulting in a better sealing effect.

[0096] In some embodiments, the two ends of the cardiac occluder 100 are respectively connected to the center of the first disc portion 10 and the second disc portion 30.

[0097] In some embodiments of the present invention, the first disk portion 10 and the second disk portion 30 may be arranged symmetrically.

[0098] In some embodiments, the sealing portion 20 is a columnar structure, with a first disc portion 10 connected to one axial end of the sealing portion 20 and a second disc portion 30 connected to the other axial end of the sealing portion 20. The first disc portion 10 and the second disc portion 30 are symmetrically arranged relative to the central radial plane of the sealing portion 20 (a radial plane located at the midpoint of the axial direction of the sealing portion 20). The distance between the connection point of the first disc portion 10 and the sealing portion 20 and the plane of symmetry is the same as the distance between the connection point of the second disc portion 30 and the sealing portion 20 and the plane of symmetry. The shape, projected area, and thickness of the first disc portion 10 and the second disc portion 30 are identical. The number, structure, and dimensions of the first radial ribs on the first disc portion 10 are the same as the number, structure, and dimensions of the second radial ribs on the second disc portion 30, and the number, structure, and dimensions of the first radial ribs a on the first disc portion 10 are the same as the number, structure, and dimensions of the second radial ribs b on the second disc portion 30. Both the first disc portion 10 and the second disc portion 30 are constructed as hollow structures.

[0099] Of course, in other embodiments of the present invention, the first disk portion 10 and the second disk portion 30 may also be arranged asymmetrically.

[0100] Asymmetrical arrangement refers to the different dimensions of the first disc 10 and the second disc 30, such as different thicknesses, one being a solid part and the other a hollow part. That is, the first disc 10 and the second disc 30 have different shapes, projected areas and thicknesses. The first disc 10 and the second disc 30 can be adaptively adjusted according to the shape and slope of the surrounding surface of the structure to be sealed, so that the shapes of the first disc 10 and the second disc 30 fit better, which is conducive to cell tissue climbing and growth and improves the repair effect.

[0101] For example, when the pressure on one side of the structure to be sealed is greater than the pressure on the other side, the projected area of ​​the disc on the side with higher pressure can be made larger so that it can better resist the impact of the medium flow, reduce the probability of the heart occluder 100 falling off, and improve the fixation stability and reliability.

[0102] Optionally, the first radial rib a can be provided only on the first plate portion 10, or the second radial rib b can be provided only on the second plate portion 30, or both the first radial rib a and the second radial rib b can be provided simultaneously. The portions of the first radial rib a and the second radial rib b located on the sealing portion 20 can be connected or spaced apart.

[0103] In some embodiments of the present invention, the surface of the first disc portion 10 facing the sealing portion 20 is the first inner surface, and the surface away from the sealing portion 20 is the first outer surface. The surface of the second disc portion 30 facing the sealing portion 20 is the second inner surface, and the surface away from the sealing portion 20 is the second outer surface. The first outer surface has a greater surface roughness than the first inner surface; the second outer surface has a greater surface roughness than the second inner surface. The first and second outer surfaces have a certain degree of roughness, which is conducive to cell climbing and growth and improves the repair effect, while the first and second inner surfaces can better fit with the surrounding surfaces.

[0104] Furthermore, the first disc 10 is also provided with a connecting part 40, which is convenient for gripping with forceps to push the heart occluder 100. The forceps of the pushing component can be selectively connected to the connecting part 40. When the pushing component is connected to the connecting part 40, it can drive the heart occluder 100 to move. When the pushing component is released from the connecting part 40, the pushing component can be removed.

[0105] During the surgical procedure, the push component is first kept in a stable connection with the connecting part 40. The push component drives the cardiac occluder 100 to move along the sheath until it reaches the structure to be occluded.

[0106] In some embodiments of the present invention, the connecting portion 40 may be a hole, a recess, or a protrusion, and the pushing component is connected to the connecting portion 40. Optionally, the hole, recess, or protrusion may be a circular, elliptical, triangular, or composite geometric shape; the hole may be a through structure, the recess or protrusion may be a non-through structure, and the protrusion may be a flat protrusion or a cylindrical protrusion.

[0107] In some embodiments of the present invention, the connecting portion 40 may be configured as a flat block, and the connecting portion 40 extends axially along the sealing portion 20.

[0108] The cardiac occluder 100 of this invention has an integral structure and is an elastic element that can automatically return to its original shape. When the cardiac occluder 100 is withdrawn from the sheath, it automatically returns to its original shape. Therefore, there is no need to set up an additional driving component to drive the cardiac occluder 100 to return to its original shape, which can reduce manufacturing costs and simplify surgical procedures. The connecting part 40 is constructed as a flat block, and a grasping forceps can be used as a pushing component. The grasping forceps clamp the flat block to connect with the cardiac occluder 100. The connection and release operation of the grasping forceps is simple and can simplify surgical procedures.

[0109] In some embodiments of the present invention, the surface of the flat block is provided with a plurality of ribs spaced apart along the axial direction. By providing ribs, the surface friction of the flat block can be increased, and the ribs play an anti-slip role, which can further improve the connection stability between the pushing component and the flat block, and improve the working reliability of the cardiac occluder 100.

[0110] like Figure 1 , Figure 2 and Figure 3 As shown, in the first embodiment of this application, the first disc portion 10, the second disc portion 30, and the sealing portion 20 are all constructed as hollow structures and do not have radial ribs.

[0111] like Figure 4 , Figure 5 and Figure 6 As shown, in the second embodiment of this application, the first disc portion 10 is constructed as a hollow structure, the second disc portion 30 and the sealing portion 20 are constructed as solid parts, a first radial rib a is provided between the first disc portion 10 and the sealing portion 20, and a second radial rib b is provided between the second disc portion 30 and the sealing portion 20.

[0112] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0113] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A dual-disc, one-piece molded cardiac occluder, characterized in that, include: The first disc (10), the second disc (30), and the sealing part (20) are connected to the two ends of the sealing part (20) in the axial direction. The first disc (10), the second disc (30), and the sealing part (20) are integrally formed. The first disc (10), the second disc (30), and the sealing part (20) are all biodegradable parts. The first disc portion (10), the second disc portion (30), and the sealing portion (20) are all constructed as elastic elements. At least the first disc portion (10) is constructed as a hollow structure. The first disc portion (10) and the second disc portion (30) are adapted to switch between a retracted state and an unfolded state. In the retracted state, the first disc portion (10) and the second disc portion (30) extend away from each other along the axial direction of the sealing portion (20) to retract. In the unfolded state, the first disc portion (10) and the second disc portion (30) extend radially along the sealing portion (20) to form a disc shape.

2. The dual-disc, integrally molded cardiac occluder according to claim 1, characterized in that, In the unfolded state, the first disc portion (10) includes a first wall (11), a second wall (12), and a third wall (13). The first wall (11) and the second wall (12) are axially opposite each other. The radially inner edge of the first wall (11) is connected to the sealing portion (20). The second wall (12) or the first wall (11) defines a closed surface. The radially outer edges of the first wall (11) and the second wall (12) are respectively connected to the axial ends of the third wall (13) and define a first cavity so that in the retracted state, the first wall (11) and the second wall (12) are moved away from each other on the radially inner side of the sealing portion (20) adjacent to each other.

3. The dual-disc, integrally molded cardiac occluder according to claim 2, characterized in that, A first radial rib (a) is provided between the first wall (11) and the sealing part (20).

4. The dual-disc, integrally molded cardiac occluder according to claim 2, characterized in that, The sealing part (20) is a solid part. One end of the sealing part (20) is connected to the first wall (11), and the other end of the sealing part (20) is connected to the second disc part (30).

5. The dual-disc, integrally molded cardiac occluder according to claim 2, characterized in that, The sealing part (20) is constructed as a hollow structure. The sealing part (20) has an annular wall. The two axial ends of the annular wall are connected to the first disk part (10) and the second disk part (30) respectively. The annular wall defines a second cavity that communicates with the first cavity.

6. The dual-disc, integrally molded cardiac occluder according to claim 5, characterized in that, At least one expansion groove (21) extending axially is provided on the annular wall.

7. The dual-disc, integrally molded cardiac occluder according to claim 1, characterized in that, The second disc (30) is constructed as a solid part.

8. The dual-disc, integrally molded cardiac occluder according to claim 1, characterized in that, The second disc (30) is constructed as a hollow structure. In the unfolded state, the second disc (30) includes a fourth wall (31), a fifth wall (32), and a sixth wall (33). The fourth wall (31) and the fifth wall (32) are arranged opposite each other in the axial direction. The radial inner edge of the fourth wall (31) is connected to the sealing part (20). The fifth wall (32) or the fourth wall (31) defines a closed surface. The radial outer edges of the fourth wall (31) and the fifth wall (32) are respectively connected to the axial ends of the sixth wall (33) and define a third cavity so that in the retracted state, the fourth wall (31) and the fifth wall (32) are far away from each other in the radial inner direction of the sealing part (20) in the axial direction.

9. The dual-disc, integrally molded cardiac occluder according to claim 7 or 8, characterized in that, A second radial rib (b) is provided between the second disc portion (30) and the blocking portion (20), or on the side of the second disc portion (30) away from the blocking portion (20).

10. The dual-disc, integrally molded cardiac occluder according to claim 1, characterized in that, The first disc portion (10), the second disc portion (30) and the sealing portion (20) are all constructed as hollow structures, and the first cavity of the first disc portion (10), the second cavity of the sealing portion (20) and the third cavity of the second disc portion (30) are connected.

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