Plugging device and plugging system

Abstract

The invention relates to the technical field of medical instruments and discloses a plugging device and a plugging system, the plugging device is of a semi-closed structure, a containing cavity is formed in the plugging device, an opening of the plugging device communicates with the containing cavity, the opening is suitable for allowing fluid to flow into the containing cavity, and the plugging device is suitable for expanding under the pressure of the fluid. The plugging device can be implanted between a valve support and a heart valve ring, an opening of the plugging device faces the blood inflow side, namely the far-end side, blood flows into the plugging device through the opening of the plugging device in the flowing process, and along with increase of the blood in the plugging device, the plugging device can be used for plugging the heart valve ring. The plugging device expands after being subjected to blood pressure and can be attached to the valve stent and the heart valve ring, so that a gap between the valve stent and the heart valve ring is plugged, and the problem of perivalvular leakage can be relieved; the plugging device expands by means of blood flowing in the body, so that the plugging device can adapt to the gap between the valve stent and the heart valve ring, and the plugging effect on perivalvular leakage can be improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a plugging device and a plugging system. Background Art

[0002] What is provided in this part is only background information related to the present invention, and it is not necessarily prior art.

[0003] A valve stent, that is, a prosthetic valve or an artificial valve, can be implanted into the heart to assist in the treatment of valve diseases. When the valve stent is implanted into the heart, there may be a gap between the valve stent and the cardiac annulus due to the valve stent not being implanted in an ideal position or the valve stent being displaced after implantation, resulting in paravalvular leakage. Severe paravalvular leakage can lead to hemolysis, which is very harmful to the patient's quality of life and health. Summary of the Invention

[0004] The object of the present invention is to at least alleviate the problem of paravalvular leakage caused by the gap between the valve stent and the prosthetic annulus. This object is achieved by the following technical solutions:

[0005] A first aspect of the present invention provides a plugging device. The plugging device has a semi-closed structure, a cavity is provided inside the plugging device, an opening of the plugging device is communicated with the cavity, the opening is adapted to allow a fluid to flow into the cavity, and the plugging device is adapted to expand under the pressure of the fluid.

[0006] According to the plugging device of the present invention, it can be implanted between the valve stent and the cardiac annulus. Among them, the opening of the plugging device faces the blood inflow side, that is, the distal side. During the blood flow, the blood flows through the opening of the plugging device into the plugging device. As the blood in the plugging device increases, the plugging device expands under the pressure of the blood and can fit with the valve stent and the cardiac annulus, thereby plugging the gap between the valve stent and the cardiac annulus and alleviating the problem of paravalvular leakage. Moreover, the plugging device relies on the blood flowing in the body to expand, enabling the plugging device to adapt to the gap between the valve stent and the cardiac annulus, which is beneficial to improving the plugging effect on paravalvular leakage.

[0007] In addition, according to the plugging device of the present invention, it may also have the following additional technical features:

[0008] In some embodiments of the present invention, the plugging device includes a first side wall, a second side wall and a bottom wall connected to each other. The first side wall, the second side wall and the bottom wall enclose the semi-closed structure. The bottom wall is disposed opposite to the opening. Along the circumferential direction of the plugging device, both the first side wall and the second side wall are arc-shaped, and the convex directions of the first side wall and the second side wall are the same.

[0009] In some embodiments of the present invention, the curvature of the first sidewall in the circumferential direction of the occlusion device is smaller than the curvature of the second sidewall in the circumferential direction of the occlusion device.

[0010] In some embodiments of the present invention, the stiffness of the first sidewall is smaller than the stiffness of the second sidewall.

[0011] In some embodiments of the present invention, both ends of the first sidewall and both ends of the second sidewall are respectively connected through a connecting portion, and the stiffness of the connecting portion is smaller than the stiffness of the first sidewall or the second sidewall.

[0012] In some embodiments of the present invention, the first sidewall includes a first middle portion and two first end portions. Along the direction from the bottom wall towards the opening, the first middle portion is located between the two first end portions, and the spacing distance between the first middle portion and the second sidewall is smaller than the spacing distance between the first end portion and the second sidewall.

[0013] In some embodiments of the present invention, at least a part of one end of the second sidewall facing away from the bottom wall extends towards the side of the first sidewall facing away from the bottom wall.

[0014] In some embodiments of the present invention, one end of the second sidewall facing away from the bottom wall is bent towards the first sidewall.

[0015] In some embodiments of the present invention, the bottom wall includes a bottom skeleton and a bottom film. The bottom film covers the sidewall of the bottom skeleton, and the stiffness of the bottom skeleton is smaller than the stiffness of the first sidewall or the second sidewall.

[0016] In some embodiments of the present invention, a filter membrane is further included. The filter membrane communicates with the opening and covers the opening. The filter membrane is suitable for blood to pass through and is suitable for blocking thrombus.

[0017] A second aspect of the present invention provides an occlusion system, including a valve stent and the occlusion device according to the present invention or any embodiment of the present invention. Description of the Drawings

[0018] By reading the detailed description of the preferred embodiments below, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present invention. Moreover, throughout the drawings, the same reference numerals are used to represent the same components. In the drawings:

[0019] Figure 1 It is a schematic diagram of the occlusion device according to some embodiments of the present invention disposed in the body;

[0020] Figure 2Schematic diagrams before and after the expansion of the occlusion device according to some embodiments of the present invention;

[0021] Figure 3 Cross-sectional schematic diagram of the occlusion device according to some embodiments of the present invention;

[0022] Figure 4 Structural schematic diagram of the occlusion device according to some embodiments of the present invention;

[0023] Figure 5 Schematic diagram of the curvature relationship of the occlusion device according to some embodiments of the present invention from a top view perspective;

[0024] Figure 6 Schematic diagram of the bottom wall of the occlusion device according to some embodiments of the present invention;

[0025] Figure 7 Schematic cross-sectional diagram of the occlusion device according to some embodiments of the present invention;

[0026] Figure 8 Structural diagram of the occlusion device according to some embodiments of the present invention from a top view perspective;

[0027] Figure 9 Top view assembly diagram of the first and second frameworks according to some embodiments of the present invention;

[0028] Figure 10 Expanded schematic diagram of the first framework, connecting part and second framework according to some embodiments of the present invention;

[0029] Figure 11 Assembly schematic diagram of the first framework, second framework and bottom wall according to some embodiments of the present invention;

[0030] Figure 12 Structural diagram of the occlusion device according to some embodiments of the present invention;

[0031] Figure 13 Schematic diagram of the occlusion device according to some embodiments of the present invention.

[0032] Reference numerals are as follows:

[0033] 10. Valve stent; 20. Heart valve annulus; 21. Left ventricle; 22. Left atrium;

[0034] 100, Plugging device; 101, Support framework; 102, Coating film; 103, Annular middle part; 104, Annular end part; 110, First side wall; 111, First framework; 112, First middle part; 113, First end part; 120, Second side wall; 121, Second framework; 122, Second middle part; 123, Second end part; 130, Bottom wall; 131, Bottom framework; 132, Bottom coating film; 140, Opening; 150, Connecting part; 151, Rod-shaped part; 160, Filter membrane; 170, Cavity;

[0035] 200, Developing structure. Detailed implementation mode

[0036] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present invention can be more thoroughly understood and the scope of the present invention can be completely conveyed to those skilled in the art.

[0037] It should be understood that the terms used herein are only for the purpose of describing specific exemplary embodiments and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" as used herein may also include the plural forms. The terms "comprising", "including", "containing", and "having" are inclusive and thus specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be performed in the particular order described or illustrated, unless the order of performance is explicitly stated. It should also be understood that additional or alternative steps may be used.

[0038] Although the terms first, second, third, etc. may be used in the text to describe multiple elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms can only be used to distinguish one element, component, region, layer, or section from another region, layer, or section. Unless the context clearly indicates otherwise, terms such as "first" and "second" and other numerical terms used in the text do not imply an order or sequence. Therefore, the first element, component, region, layer, or section discussed below can be referred to as the second element, component, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0039] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature shown in the figure relative to another element or feature. These relative terms include, for example, "inner", "outer", "inner side", "outer side", "below", "beneath", "above", "upper", etc. Such spatial relative terms are intended to include different orientations of the device during use or operation other than the orientations depicted in the figure. For example, if the device in the figure is flipped, an element described as "below" or "beneath" other elements or features will then be oriented as "above" or "upper" other elements or features. Therefore, the exemplary term "below" can include both upper and lower orientations.

[0040] In the text, the direction of the Z-axis is defined as the up-down direction, the positive direction of the Z-axis refers to up, and the negative direction of the Z-axis refers to down. The direction of the X-axis is defined as the left-right direction, the positive direction of the X-axis is right, and the negative direction of the X-axis is left. The direction of the Y-axis is defined as the front-back direction, the positive direction of the Y-axis is front, and the negative direction of the Y-axis is back.

[0041] Refer to Figure 1 As shown, in this embodiment, a plugging device 100 is proposed. The plugging device 100 is a semi-closed structure with one end open 140. A cavity 170 is provided inside the plugging device 100. The opening 140 of the plugging device 100 is in communication with the cavity 170. The opening 140 is adapted to allow blood to flow in, and the plugging device 100 is adapted to expand under the pressure of the blood.

[0042] Refer to Figure 1 As shown, the plugging device 100 is in a semi-closed structure. The semi-closed structure means that the inner side of the plugging device 100 is in a cavity structure. The inner side of the plugging device forms a cavity 170. An opening 140 is provided at one end of the plugging device. The opening 140 is in communication with the cavity 170. Blood can flow from the opening 140 into the cavity 170 and accumulate in the cavity 170.

[0043] Continue to refer to Figure 1 As shown, the plugging device 100 can be interposed between the valve stent 10 and the cardiac valve annulus 20 to plug the gap between the valve stent 10 and the cardiac valve annulus 20 and prevent blood from passing through this gap to form paravalvular leakage. Specifically, when the plugging device 100 is implanted in the body, it can be in contact with the valve stent 10 on one side and in contact with the cardiac valve annulus 20, the left ventricle 21, and the left atrium 22 on the other side. After the plugging device 100 is implanted in the body, the opening 140 of the plugging device 100 faces the blood inflow side of the valve stent 10, that is, faces the proximal side B. Blood in the left atrium 22 can flow into the cavity 170 of the plugging device 100 through the opening 140. Among them, Figure 1Among them, arrow A indicates the blood flow direction. The proximal side B of the valve stent 10 is on the side where the blood flows in, and the distal side C of the valve stent 10 is at the end where the blood flows out.

[0044] Continue to refer to Figure 1 and Figure 2 As shown, since the other end of the occlusion device 100 (the end far from the opening 140) is closed, the occlusion device 100 can occlude the gap between the valve stent 10 and the cardiac valve annulus 20 to limit the blood flow through this gap to the distal side C. The blood flowing into the occlusion device 100 accumulates in the cavity 170 until the cavity 170 is filled. Under the action of the accumulation pressure of the blood flow, the occlusion device 100 can further expand, increasing the acting force between the occlusion device 100 and the valve stent 10 and the cardiac valve annulus 20, improving the occlusion effect on the gap between the valve stent 10 and the cardiac valve annulus 20, and increasing the anchoring force of the occlusion device 100.

[0045] For example, in one embodiment, refer to Figure 2 As shown, when the occlusion device 100 is implanted between the valve stent 10 and the cardiac valve annulus 20, the occlusion device 100 has self-expanding property. After the occlusion device 100 self-expands and expands, it fits with the valve stent 10 and the cardiac valve annulus 20 respectively. At this time, the occlusion device 100 is in the a1 state (as shown by the solid line). After the occlusion device 100 is implanted, the blood enters the cavity 170 from the opening 140. The blood accumulates in the cavity 170, forming an expansion force on the side wall of the occlusion device 100, causing the occlusion device 100 to further expand. At this time, the occlusion device is in the a2 state (as shown by the dashed line). Figure 2 In , a1 is the state when the occlusion device 100 is just implanted into the body, and a2 is the state after the occlusion device 100 expands under the action of the blood pressure.

[0046] The occlusion device 100 of this embodiment can expand under the action of the blood flow pressure, so that there is a strong adhesion force between the occlusion device 100 and the valve stent 10 and the cardiac valve annulus 20. There is a good fitting sealing performance and anchoring force between the occlusion device 100 and the valve stent 10 and the cardiac valve annulus 20, which is beneficial to improving the occlusion effect and can also prevent the occlusion device 100 from detaching from the cardiac valve annulus 20. At the same time, when the blood in the left atrium 22 flows into the occlusion device 100, thrombus will gradually form and deposit in the cavity 170, and finally completely occlude the gap between the valve stent 10 and the cardiac valve annulus 20, and the long-term occlusion effect is good.

[0047] In some embodiments, please refer to Figure 3, the occluding device 100 includes a support framework 101 and a film 102. The film 102 covers the side wall of the support framework 101 to form a semi-closed structure. The support framework 101 can be a mesh structure woven from nitinol wires or a mesh structure formed by laser cutting. The film 102 can be disposed at the bottom end of the support framework 101 (i.e., the end pointed in the negative Z-axis direction). The film 102 can also cover all the side walls of the support framework 101. The film 102 can be disposed inside the support framework 101 or cover the outside of the support framework 101. A cavity 170 for accommodating blood is formed inside the film 102.

[0048] As Figure 3 shown, in some embodiments, the occluding device 100 includes a first side wall 110, a second side wall 120, and a bottom wall 130. The first side wall 110 and the second side wall 120 are oppositely disposed. The first side wall 110 and the second side wall 120 are both connected to the bottom wall 130 to enclose a semi-closed structure. The bottom wall 130 is oppositely disposed to the opening 140.

[0049] As Figure 4 shown, along the circumferential direction of the occluding device 100, both the first side wall 110 and the second side wall 120 are arc-shaped structures, and the convex directions of the first side wall 110 and the second side wall 120 are the same.

[0050] Referring to Figure 5 shown, the circumferential direction of the occluding device 100 can be understood with reference to the auxiliary line b1 or b2 in Figure 5 . The auxiliary lines b1 and b2 can be understood as the contour lines after the arc-shaped contours of the first side wall 110 and the second side wall 120 extend along the circumferential direction.

[0051] Referring to Figure 5 shown, the first side wall 110 is arc-shaped along the circumferential direction of the occluding device 100, and the convex surface of the first side wall 110 faces the negative direction of the X-axis; the second side wall 120 is arc-shaped along the circumferential direction of the occluding device 100, and the convex surface of the second side wall 120 faces the negative direction of the X-axis. The bending directions of the first side wall 110 and the second side wall 120 are the same, which means that the convex surfaces of the first side wall 110 and the second side wall 120 face the same direction. After the occluding device 100 is implanted into the body, both the first side wall 110 and the second side wall 120 bulge towards the valve stent 10 side.

[0052] After the occluding device 100 is implanted into the body, the first side wall 110 fits with the valve stent 10, and the second side wall 120 fits with the cardiac valve annulus 20. Both the first side wall 110 and the second side wall 120 are arc-shaped, which can improve the fitting degree between the occluding device 100 and the valve stent 10 and between the occluding device 100 and the cardiac valve annulus 20, and is beneficial to improving the stability of the occluding device 100 implanted into the body and the occluding effect on paravalvular leakage.

[0053] Continue to refer to Figure 5 , the curvature of the first side wall 110 along the circumference of the occlusion device 100 is less than the curvature of the second side wall 120 along the circumference of the occlusion device 100.

[0054] The curvature of an arc is equal to the reciprocal of the radius of the osculating circle corresponding to the arc, that is, k = 1 / R, where k is the curvature and R is the radius. The larger the radius corresponding to the arc, the smaller the curvature. As Figure 5 shown, the radius of the osculating circle corresponding to the arc of the first side wall 110 (this osculating circle can be understood with reference to the auxiliary line b1) is R1, and the radius of the osculating circle corresponding to the arc of the second side wall 120 (this osculating circle can be understood with reference to the auxiliary line b2) is R2, and R1 is greater than R2. In this way, the curvature of the corresponding first side wall 110 is less than the curvature of the second side wall 120.

[0055] It should be noted that at the position where paravalvular leakage occurs, the curvature of the valve stent 10 is usually less than the curvature of the cardiac valve annulus 20. In this way, by making both the first side wall 110 and the second side wall 120 arc-shaped and the convex surfaces of the first side wall 110 and the second side wall 120 facing the same direction, the first side wall 110 with a smaller curvature fits the valve stent 10, and the second side wall 120 with a larger curvature fits the cardiac valve annulus 20, making the first side wall 110 and the second side wall 120 more conform to the contours of the valve stent 10 and the cardiac valve annulus 20. Thus, on the one hand, the influence of the first side wall 110 on the compression deformation of the valve stent 10 can be reduced, and the valve leaflets in the valve stent 10 can be prevented from being squeezed due to the deformation of the valve stent 10, resulting in central reflux in the valve stent 10. On the other hand, the first side wall 110 and the second side wall 120 can be made to fit the contours of the valve stent 10 and the cardiac valve annulus 20 as much as possible, reducing the probability of paravalvular leakage.

[0056] Optionally, in some embodiments, the stiffness of the first side wall 110 is less than the stiffness of the second side wall 120.

[0057] Stiffness corresponds to the ease of deformation. The greater the stiffness, the more difficult it is to deform. The smaller the stiffness, the easier it is to deform. The stiffness of the first side wall 110 and the second side wall 120 is usually limited by the stiffness of the corresponding support skeleton 101. For the sake of description, the support skeleton 101 corresponding to the first side wall 110 is defined as the first skeleton 111, and the support skeleton 101 corresponding to the second side wall 120 is defined as the second skeleton 121.

[0058] In this embodiment, the stiffness of the first framework 111 is greater than that of the second framework 121. The first framework 111 and the second framework 121 can be made by selecting braided wires with appropriate strength. For example, the wire diameter of the braided wire of the first framework 111 can be smaller than that of the braided wire of the second framework 121, so that the stiffness of the first framework 111 is greater than that of the second framework 121. The first framework 111 and the second framework 121 can also be made by the braiding density of the first framework 111 being smaller than that of the second framework 121, or the mesh density of the first framework 111 being smaller than that of the second framework 121, or the mesh area of the smallest mesh of the first framework 111 being greater than the mesh area of the largest mesh of the second framework 121, etc., so that the stiffness of the first framework 111 is greater than that of the second framework 121.

[0059] In this embodiment, the four-point support method is used to measure the stiffness of the first side wall 110 and the second side wall 120. Specifically, the vertices of the four corners of the first side wall 110 are fixed, and a concentrated force is applied at the center position of the first side wall 110. The magnitude of the stiffness of the first side wall 110 is judged by judging the deformation amount of the first side wall 110. The vertices of the four corners of the second side wall 120 are fixed, and a concentrated force is applied at the center position of the second side wall 120. The magnitude of the stiffness of the second side wall 120 is judged by judging the deformation amount of the second side wall 120. It can be understood that in other embodiments, the stiffness of the first side wall 110 and the second side wall 120 can also be measured by the stretching method. Specifically, during the measurement of the first side wall 110, both ends of its first framework 111 are clamped respectively by a clamp, and a tensile force is applied to the first framework 111 to measure its elastic deformation amount, so as to obtain the stiffness of the first framework 111. When measuring the stiffness of the second side wall 120, both ends of the second side wall 120 are clamped respectively by a clamp, and a tensile force is applied to the second side wall 120 to measure its elastic deformation amount, so as to obtain the stiffness of the second side wall 120.

[0060] It can be understood that the stiffness of the first side wall 110 is less than that of the second side wall 120, making the first side wall 110 more prone to deformation relative to the second side wall 120. In this way, when the first side wall 110 is pressed by the valve stent 10, it is more likely to be deformed by the force, preventing the occlusion device 100 from squeezing the valve stent 10 and affecting the closing of the valve leaf in the valve stent 10.

[0061] In some embodiments, the stiffness of the bottom wall 130 is less than the stiffness of the first side wall 110 or less than the stiffness of the second side wall 120.

[0062] Optionally, the bottom wall 130 may be provided with only the film 102 without the support framework 101, and the first side wall 110 and the second side wall 120 are both provided with the support framework 101, so that the stiffness of the bottom wall 130 is less than the stiffness of the first side wall 110 or the second side wall 120. It is also possible that the bottom wall 130 is provided with both the film 102 and the support framework 101. For the convenience of description, please refer to Figure 6 , the support framework 101 corresponding to the bottom wall 130 is defined as the bottom framework 131. By making the stiffness of the bottom framework 131 less than the stiffness of the first framework 111 and the second framework 121, the stiffness of the bottom wall 130 is less than the stiffness of the first side wall 110 and the second side wall 120. The film 102 covering the bottom framework 131 is defined as the bottom film 132. The bottom film 132 covers the side walls of the bottom framework 131. The bottom film 132 may be provided on the inner wall of the bottom framework 131 or on the outer wall of the bottom framework 131.

[0063] The bottom framework 131 can provide support for the bottom film 132 on the inner side, which can reduce the deformation amount of the bottom film 132 that is recessed towards the distal end due to the pressure difference between the left ventricle 21 and the left atrium 22.

[0064] Specifically, the bottom framework 131, the first framework 111, and the second framework 121 can be made of braided wires with appropriate strength selected to achieve different stiffnesses of the bottom framework 131, the first framework 111, and the second framework 121. For example, the wire diameter of the braided wires of the bottom framework 131 can be less than the wire diameters of the braided wires of the first framework 111 and the second framework 121, so that the stiffness of the first framework 111 is greater than the stiffness of the second framework 121. The first framework 111 and the second framework 121 can also be made such that the braiding density of the bottom framework 131 is less than the braiding densities of the first framework 111 and the second framework 121, or the mesh density of the bottom framework 131 is less than the mesh densities of the first framework 111 and the second framework 121, or the mesh area of the smallest mesh of the bottom framework 131 is respectively larger than the mesh areas of the largest meshes of the first framework 111 and the second framework 121, etc., to make the stiffness of the bottom framework 131 less than the stiffnesses of the first framework 111 and the second framework 121.

[0065] It can be understood that, please refer to Figure 3 and Figure 4, the stiffness of the bottom wall 130 is less than that of the first side wall 110 or the second side wall 120. The first side wall 110 and the second side wall 120 have good support strength. After blood enters the occlusion device 100, under the pressure of the fluid, both ends of the bottom wall 130 are more likely to move away from each other on the X-axis, so that the distance between the first side wall 110 and the second side wall 120 in the X-axis direction increases, facilitating the radial expansion of the occlusion device 100 to occlude the gap between the valve stent 10 and the cardiac valve annulus 20, and at the same time increasing the anchoring force between the occlusion device 100 and the valve stent 10 and the cardiac valve annulus 20.

[0066] Please continue to refer to Figure 4 , the perimeter of the middle part of the occlusion device 100 is set to be the smallest, so that after the waist of the occlusion device 100 is compressed, a closure can be formed at the waist, reducing the possibility of blood flow overflowing from the opening 140. For example, in one embodiment, the occlusion device 100 includes an annular middle part 103 and two annular end parts 104. Along the Z-axis direction, the annular middle part 103 is located between the two annular end parts 104. Along the circumferential direction of the occlusion device 100, the perimeter of the annular end part 104 is greater than that of the annular middle part 103.

[0067] Specifically, referring to Figure 7 , Figure 8 As shown, along the circumferential direction of the occlusion device 100, the extension length (i.e., the perimeter) of the second end part 123 is greater than the extension length (i.e., the perimeter) of the second middle part 122. In this way, the perimeter of the middle part of the occlusion device 100 is the shortest, causing the middle part of the occlusion device 100 to shrink. After the occlusion device 100 is compressed, the middle part of the first side wall 110 is more likely to fit with the second side wall 120 to form a closure, reducing the possibility of blood being squeezed out from the opening 140, promoting the formation of thrombus in the blood flow within the occlusion device 100. After the thrombus is formed, the sealing performance of the occlusion device 100 can be increased, improving the sealing effect of the occlusion device 100.

[0068] In some embodiments, referring to Figure 7 and Figure 8 , the first side wall 110 includes a first middle part 112 and two first end parts 113. Along the direction of the bottom wall 130 towards the opening 140, the first middle part 112 is located between the two first end parts 113. Along the direction of the first side wall 110 towards the second side wall 120, the spacing distance L1 between the first middle part 112 and the second side wall 120 is less than the spacing distance L2 between the first end part 113 and the second side wall 120.

[0069] Referring to Figure 7As shown, the spacing distance between the first side wall 110 and the second side wall 120 can be understood by referring to the spacing distance between the first skeleton 111 and the second skeleton 121 at the same height position (position in the Z-axis direction), and the distance is a straight-line distance along the thickness direction of the sealing device 100 (understood by referring to the X-direction).

[0070] Optionally, the second side wall 120 includes a second middle portion 122 and two second end portions 123. The second middle portion 122 is disposed between the two annular end portions 104 along the direction of the bottom wall 130 toward the opening 140. The second middle portion 122 protrudes toward the first side wall 110, so that the spacing distance L1 between the second middle portion 122 and the first middle portion 112 is smaller than the spacing distance L2 between the second end portion 123 and the corresponding first end portion 113.

[0071] The middle part of the blocking device 100 (i.e., the position corresponding to the first middle part 112 or the second middle part 122) is retracted, so that the distance between the first side wall 110 and the second side wall 120 is smaller. In this way, after the blocking device 100 is pressurized, the stiffness of the first side wall 110 is less than that of the second side wall 120, so that the first side wall 110 is easier to move toward the direction of the second side wall 120. Then, the smaller distance between the first side wall 110 and the second side wall 120 in the middle part of the blocking device 100 makes it easier for the waist of the first side wall 110 to fit with the second side wall 120 to form a seal, thereby reducing the possibility of blood being squeezed and flowing out of the opening 140, so as to promote the blood flow in the blocking device 100 to form a thrombus. After the thrombus is formed, the sealing of the blocking device 100 can be increased, thereby improving the sealing effect of the blocking device 100.

[0072] In some embodiments, reference Figure 7 As shown, one end of the second side wall 120 facing away from the bottom wall 130 (i.e., the second end 123 facing away from the bottom wall 130) at least partially extends toward the first side wall 110 in a direction away from the second side wall 120, and the second end 123 of the second side wall 120 facing away from the bottom wall 130 is at least partially located on the side of the first side wall 110 away from the bottom wall 130.

[0073] The height of the second sidewall 120 is greater than the height of the first sidewall 110. The second end 123 of the second sidewall 120 facing away from the bottom wall 130 extends towards the side away from the bottom wall 130. The second end 123 of the second sidewall 120 facing away from the bottom wall 130 is at least partially located on the side pointed by the first sidewall 110 in the positive Z-axis direction. There is a distance L3 between the distal ends of the second sidewall 120 and the first sidewall 110 in the Z-axis direction, and a height difference is formed between the second sidewall 120 and the first sidewall 110. During the process of the occlusion device 100 being squeezed, the blood flow above the middle part (i.e., the position corresponding to the first middle part 112 or the second middle part 122) in the occlusion device 100 is squeezed and flows towards the distal side. The second sidewall 120 blocks the blood flow towards the distal side, facilitating the blood flow to return to the cavity 170. On the other hand, it also facilitates guiding the blood flow towards the direction of the valve stent 10, promoting blood circulation.

[0074] In some embodiments, referring to Figure 7 As shown, one end of the second sidewall 120 facing away from the bottom wall 130 (i.e., the second end 123 facing away from the bottom wall 130) is at least partially bent towards the side where the first sidewall 110 is located.

[0075] The second end 123 of the second sidewall 120 facing away from the bottom wall 130 can be bent towards the first sidewall 110, and the second end 123 of the second sidewall 120 facing away from the bottom wall 130 forms a guiding surface. During the process of the occlusion device 100 being squeezed, part of the blood flow in the occlusion device 100 is squeezed and flows towards the distal side. While the second sidewall 120 blocks the blood flow towards the distal side, it can guide the blood towards the first sidewall 110 along the guiding surface, so that the blood can flow towards the side of the valve stent 10, which can promote blood circulation. Optionally, the curvature of the second sidewall 120 can gradually decrease from the second middle part 122 towards the end facing away from the bottom wall 130 to improve the blood guiding effect of the second sidewall 120 on the blood.

[0076] In some embodiments, the two ends of the first sidewall 110 and the two ends of the second sidewall 120 are respectively connected by a connecting part 150, and the stiffness of the connecting part 150 is less than the stiffness of the first sidewall 110 and the stiffness of the second sidewall 120.

[0077] As Figure 9 and Figure 10 shown, the two ends of the first sidewall 110 in the Y-axis direction and the two ends of the second sidewall 120 in the Y-axis direction are respectively connected by a connecting part 150. That is, one end of the first sidewall 110 is connected to one end of the second sidewall 120 by a connecting part 150, and the other end of the first sidewall 110 is connected to the other end of the second sidewall 120 by another connecting part 150. Specifically, as Figure 9As shown, the first side wall 110 includes a first framework 111, the second side wall 120 includes a second framework 121, and the first framework 111 and the second framework 121 can be connected through a connecting portion 150.

[0078] The connecting portion 150, the first framework 111, and the second framework 121 can all be formed by braiding braided wires. By selecting appropriate braided wires or braiding, etc., the stiffness of the connecting portion 150 can be made less than the stiffness of the first framework 111 and the second framework 121. In a specific embodiment, the first side wall 110, the connecting portion 150, and the second side wall 120 can be a braided framework of an integral structure. At the connecting portion 150, the braiding of the framework is looser, so that the strength of the connecting portion 150 is less than the strength of the first side wall 110 and the second side wall 120. In another embodiment, as Figure 10 shown, the connecting portion 150 is formed by connecting a plurality of rod-shaped members 151. A plurality of bending portions are provided on the rod-shaped members 151, and the plurality of bending portions can adapt to the tensile deformation of the first side wall 110 and the second side wall 120. In other embodiments, the connecting portion 150 can also be other types of flexible connectors, such as a coil structure.

[0079] In this embodiment, the tensile method is used to measure the stiffness of the connecting portion 150, the first framework 111, and the second framework 121. Specifically, during the process of measuring the first framework 111, both ends of the first framework 111 are clamped respectively with a fixture, and a tensile force is applied to the first framework 111 to measure its elastic deformation amount, so as to obtain the stiffness of the first framework 111. During the process of measuring the stiffness of the connecting portion 150, both ends of the connecting portion 150 are clamped respectively with a fixture, and a tensile force is applied to the connecting portion 150 to measure its elastic deformation amount, so as to obtain the stiffness of the connecting portion 150. When measuring the stiffness of the second framework 121, both ends of the second framework 121 are clamped respectively with a fixture, and a tensile force is applied to the second framework 121 to measure its elastic deformation amount, so as to obtain the stiffness of the second framework 121.

[0080] The occlusion device 100 of this embodiment can be implanted into the body through a sheath. The stiffness of the connecting portion 150 between the first side wall 110 and the second side wall 120 is relatively low, which can reduce the loading stress of the first side wall 110 and the second side wall 120 in the sheath, and is beneficial to improving the release convenience during the process of implanting the occlusion device 100 into the body. On the other hand, by setting the stiffness of the connecting portion 150 to be less than the stiffness of the first framework 111 and the second framework 121, it is convenient for the first framework 111 and the second framework 121 to move away from each other under the pressure of the fluid, so that the occlusion device 100 can better adhere to the valve stent 10 and the cardiac valve annulus 20.

[0081] In some embodiments, as Figure 11 shown, the occlusion device 100 is further provided with a visualization structure 200.

[0082] Specifically, a developing structure 200 can be respectively arranged on the first frame 111 and the second frame 121 for positioning during release. When the occlusion device 100 of this embodiment is implanted into the body, the release position of the first frame 111 can be positioned through the developing structure 200 on the first frame 111, so that the first side wall 110 and the support body 11 of the valve stent 10 are flush at the distal side. And the release position on the second frame 121 can be positioned through the developing structure 200 on the second frame 121, so that the distal end of the second frame 121 is higher than the distal end of the valve stent 10, which is beneficial to blood flow.

[0083] Optionally, as Figure 12 、 Figure 13 shown, a filter membrane 160 is arranged at the opening 140 of the occlusion device 100. The filter membrane 160 is suitable for blood to pass through and is suitable for blocking thrombus. The filter membrane 160 can be a polyester fabric, a polyester fiber fabric or a nylon fabric. The filter membrane 160 presents a mesh-like structure, and the pore diameter of the filter membrane 160 is between 0.01 mm and 0.5 mm. Specifically, the pore diameter of the filter membrane 160 can be 0.01 mm, 0.05 mm, 0.1 mm, 0.3 mm or 0.5 mm. Within this pore diameter range, blood flow can pass through the filter membrane 160 and enter the cavity 170, while the thrombus in the cavity 170 is difficult to pass through the filter membrane 160.

[0084] The filter membrane 160 can be fixed on the first side wall 110 and the second side wall 120. By arranging the filter membrane 160, it can be prevented that when the occlusion device 100 is squeezed, the thrombus in the cavity 170 overflows from the opening 140 of the occlusion device 100 and flows towards the distal side and enters the peripheral blood vessels to form a blockage in the blood vessels. And it is beneficial for the thrombus of the occlusion device 100 to gradually deposit and solidify, and finally completely block the perivalvular leak, which is more friendly to the long-term occlusion effect.

[0085] This embodiment also provides an occlusion system, including the occlusion device 100 and the valve stent 10 proposed in this application or any embodiment of this application. When implanted into the body, the side wall of the occlusion device 100 fits with the side wall of the valve stent 10. The specific use process can refer to the description of the occlusion device 100 above.

[0086] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any change or replacement that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. A plugging device, characterized in that, The blocking device is of a semi-closed structure. A cavity is provided inside the blocking device. An opening of the blocking device is communicated with the cavity. The opening is suitable for allowing fluid to flow into the cavity. The blocking device is suitable for expanding under the pressure of the fluid.

2. The plugging device according to claim 1, characterized in that, The sealing device includes a first side wall, a second side wall and a bottom wall that are connected to each other. The first side wall, the second side wall and the bottom wall together form the semi-closed structure. The bottom wall is arranged opposite to the opening. Along the circumference of the sealing device, the first side wall and the second side wall are both arc-shaped, and the protruding direction of the first side wall is the same as the protruding direction of the second side wall.

3. The plugging device according to claim 2, wherein, The curvature of the first side wall along the circumference of the blocking device is smaller than the curvature of the second side wall along the circumference of the blocking device.

4. The plugging device according to claim 2, characterized in that, The first side wall has a stiffness smaller than a stiffness of the second side wall.

5. The plugging device according to claim 4, characterized in that Two ends of the first side wall and two ends of the second side wall are respectively connected via connecting parts, and the rigidity of the connecting parts is smaller than the rigidity of the first side wall or the rigidity of the second side wall.

6. The plugging device according to claim 2, characterized in that, The first side wall includes a first middle portion and two first ends. Along the direction of the bottom wall toward the opening, the first middle portion is located between the two first ends. The spacing distance between the first middle portion and the second side wall is smaller than the spacing distance between the first end and the second side wall.

7. The plugging device according to claim 2, wherein, An end of the second side wall facing away from the bottom wall at least partially extends toward a side of the first side wall facing away from the bottom wall.

8. The plugging device according to claim 7, wherein, One end of the second side wall facing away from the bottom wall is bent toward the first side wall.

9. The plugging device according to claim 2, wherein, The bottom wall includes a bottom frame and a bottom covering film, wherein the bottom covering film covers the side wall of the bottom frame, and the rigidity of the bottom frame is smaller than the rigidity of the first side wall or the second side wall.

10. The plugging device according to claim 1, wherein It also includes a filter membrane, which is in communication with the opening and covers the opening, and the filter membrane is suitable for blood to pass through and for stopping blood clots.

11. A plugging system, characterized in that, It comprises a valve stent and the occluding device according to any one of claims 1-10.

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