Self-expanding sealing device

Abstract

This application provides a self-expanding occlusion device for implantation between heart valves. The device includes a self-expanding body having: an elastic surface extending circumferentially along axis A to form a hollow cavity; a first port located proximal to the elastic surface and circumferentially surrounding axis A; and a second port located distal to the elastic surface and circumferentially surrounding axis A. The first port, the cavity, and the second port are interconnected. The second port is larger than the first port. This self-expanding occlusion device cleverly integrates its structure with the flow of blood during cardiac contraction and relaxation. For patients with valvular regurgitation, the self-expanding occlusion device can effectively resolve blood regurgitation in conjunction with the native valve during systole, and reduce obstruction of blood flow during diastole.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a self-expanding occlusion device. Background Technology

[0002] Common valvular insufficiency includes mitral, tricuspid, aortic, and pulmonary valve diseases. Taking the mitral valve as an example, during cardiac systole, some blood in the left ventricle flows back into the left atrium through the incompletely closed mitral valve orifice. The left atrium simultaneously receives blood from the regurgitated blood in the left ventricle and blood from the pulmonary veins, resulting in a significant increase in left atrial blood volume and pressure, leading to left atrial hypertrophy.

[0003] During diastole, more blood flows from the left atrium to the left ventricle, causing the left ventricle to enlarge due to increased contraction. As the condition progresses from the compensated stage to the decompensated stage, both the left atrium and left ventricle develop heart failure, which in turn leads to pulmonary congestion, pulmonary hypertension, right ventricular hypertrophy, right atrial hypertrophy, right heart failure, and systemic circulatory congestion.

[0004] Traditional treatments include aggressive surgical procedures or palliative medication to combat inevitable heart failure. Surgical procedures include valve replacement and valvuloplasty. Among these, typical open-chest surgery is highly invasive, requires cardiopulmonary bypass, and carries a high risk of complications and infection. Many patients cannot tolerate the significant surgical risks and are left with no choice but to await death.

[0005] Currently, there are few minimally invasive transcatheter treatments for mitral and tricuspid regurgitation approved in China. These products all require altering the structure of the heart during the treatment process, which brings great stress and discomfort to the heart after surgery.

[0006] Therefore, there is an urgent need for a product that can treat valvular regurgitation through a minimally invasive approach without altering the heart structure. Summary of the Invention

[0007] In view of the above problems, this application provides a self-expanding sealing device to overcome or at least partially solve the above problems.

[0008] This application provides a self-expanding occlusion device for implantation between heart valves. The device includes a self-expanding body, which has the following characteristics:

[0009] An elastic surface extends circumferentially along axis A, forming a hollow inner cavity;

[0010] A first port is located at the proximal end of the elastic surface, and the first port circumferentially surrounds the axis A; and

[0011] The second port is located at the far end of the elastic surface and circumferentially surrounds the axis A;

[0012] The first port, the inner cavity, and the second port are interconnected. The second port is larger than the first port so that when the ventricular blood pressure pushes the valve to close, the second port and the first port form a first pressure difference in the inner cavity, thereby causing blood to flow from the second port into the inner cavity and causing the self-expanding body to expand. When the atrial blood pressure pushes the valve to open, the second port and the first port form a second pressure difference in the inner cavity. The second pressure difference causes some blood to flow out of the inner cavity from the second port, and some blood to flow into the inner cavity from the first port. At the same time, some blood flows from the first port to the second port outside the elastic surface, causing blood to flow out of the inner cavity and causing the self-expanding body to contract.

[0013] Another embodiment of this application provides a self-expanding occlusion device for implantation between heart valves. The device includes a self-expanding body having:

[0014] An elastic surface extends circumferentially along axis A, forming a hollow inner cavity;

[0015] A first port is located at the proximal end of the elastic surface, and the first port circumferentially surrounds the axis A; and

[0016] The second port is located at the far end of the elastic surface and circumferentially surrounds the axis A;

[0017] The first port, the inner lumen, and the second port are interconnected. The second port is larger than the first port. When the aortic blood return pushes the aortic valve to close, the second port and the first port form a first pressure difference in the inner lumen, causing blood to flow from the second port into the inner lumen, thus inflating the self-expanding body. When the left ventricle blood pressure pushes the aortic valve to open, the second port and the first port form a second pressure difference in the inner lumen. This second pressure difference causes some blood to flow out of the inner lumen from the second port, and some blood to flow into the inner lumen from the first port. At the same time, some blood flows from the first port to the second port outside the elastic surface, causing blood to flow out of the inner lumen, thus causing the self-expanding body to contract.

[0018] Another embodiment of this application provides a self-expanding occlusion device for implantation between heart valves. The device includes a self-expanding body having:

[0019] An elastic surface extends circumferentially along axis A, forming a hollow inner cavity;

[0020] A first port is located at the proximal end of the elastic surface, and the first port circumferentially surrounds the axis A; and

[0021] The second port is located at the far end of the elastic surface and circumferentially surrounds the axis A;

[0022] The first port, the inner cavity, and the second port are interconnected. The second port is larger than the first port. When the pulmonary artery blood return pushes the pulmonary valve to close, the second port and the first port form a first pressure difference in the inner cavity, thereby causing blood to flow from the second port into the inner cavity and causing the self-expanding body to expand. When the right ventricle blood pressure pushes the pulmonary valve to open, the second port and the first port form a second pressure difference in the inner cavity. The second pressure difference causes some blood to flow out of the inner cavity from the second port, and some blood to flow into the inner cavity from the first port. At the same time, some blood flows from the first port to the second port outside the elastic surface, causing blood to flow out of the inner cavity and causing the self-expanding body to contract.

[0023] Optionally, the ratio of the opening area of ​​the second port to the opening area of ​​the first port is 2:1 to 10:1.

[0024] Optionally, the first port is provided with a first fixing ring, which is connected to the elastic surface to define the shape of the first port; the second port is provided with a second fixing ring, which is connected to the elastic surface to define the shape of the second port.

[0025] Optionally, the self-expanding sealing device further includes an anchoring unit, which has:

[0026] A connector that passes through the first port, the cavity, and the second port;

[0027] A first anchoring element, the proximal end of which is connected to the connector, is used for anchoring to the atrium; and

[0028] The second anchoring element, which is connected to the distal end of the connector, is used to anchor to the ventricle.

[0029] Optionally, the first port is provided with a first fixing member, which is connected to the connector; the second port is provided with a second fixing member, which is connected to the connector.

[0030] Optionally, the anchoring unit also has a safety cap that covers the second anchor to reduce blood flow to the tissue near the second anchor.

[0031] Optionally, the elastic surface forms a cylindrical shape when it expands.

[0032] Optionally, the elastic surface is made of a soft material, and its shape and size when expanded are automatically adjusted according to the gap when the valve opens and closes.

[0033] As can be seen from the above technical solutions, the self-expanding occlusion device of this application embodiment has a simple structure and is easy to manufacture. It cleverly combines the structure of the self-expanding occlusion device with the blood flow during the heart's contraction and relaxation. For patients with valvular regurgitation, the self-expanding occlusion device can work with the original valve to effectively solve the blood regurgitation problem during the heart's contraction phase and effectively block the gap when the valve is closed. During the heart's relaxation phase, it can reduce the obstruction of the blood flow channel by the self-expanding occlusion device. Attached Figure Description

[0034] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings.

[0035] Figure 1 This is a perspective view of an embodiment of a self-expanding plugging device according to this application;

[0036] Figure 2 This is an exploded view of an embodiment of a self-expanding sealing device according to this application;

[0037] Figure 3 yes Figure 1 A bottom view of the self-expanding sealing device, viewed from the bottom upwards;

[0038] Figure 4 This is a schematic diagram of an embodiment of a self-expanding occlusion device of this application during expansion within the heart;

[0039] Figure 5 This is a schematic diagram of an embodiment of a self-expanding occlusion device of this application during contraction within the heart;

[0040] Figure 6 This is a perspective view of an embodiment of a self-expanding occlusion device of this application during expansion within the heart;

[0041] Figure 7 This is a perspective view of an embodiment of a self-expanding occlusion device of this application during contraction within the heart;

[0042] Figure 8 This is a perspective view of another embodiment of the self-expanding occlusion device of this application during expansion within the heart;

[0043] Figure 9 This is a perspective view of an embodiment of the fixing method of the anchoring unit 106 of a self-expanding sealing device according to this application;

[0044] Figure 10This is a perspective view of an embodiment of a self-expanding occlusion device of this application when it expands between the aortic valves;

[0045] Figure 11 This is a perspective view of an embodiment of a self-expanding occlusion device of this application, showing contraction between the aortic valves.

[0046] Component designation

[0047] 10: Self-expanding sealing device; 101: Elastic surface; A: Axis; 102: First port; 103: Second port; 104: First fixing ring; 105: Second fixing ring; 106: Anchoring unit; 107: Connector; 108: Inner cavity; 109: First anchor; 110: Second anchor; 111: First fixing member; 112: Second fixing member; 113: Safety helmet. Detailed Implementation

[0048] To enable those skilled in the art to better understand the technical solutions in the embodiments of this application, the technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art should fall within the protection scope of the embodiments of this application.

[0049] The term "proximal" refers to the end of the self-expanding occlusion device implanted in or near the atrium when placed in the heart. The term "distal" refers to the end of the self-expanding occlusion device implanted in or near the ventricle when placed in the heart.

[0050] The specific implementation of the embodiments of this application will be further described below with reference to the accompanying drawings.

[0051] See Figures 1 to 7 In one specific implementation of this application, a self-expanding occlusion device 10 is provided for implantation between heart valves. The valve includes leaflets and annulus, and includes, but is not limited to, mitral, tricuspid, aortic, and pulmonary valves. The ventricles include the left and right ventricles, and the atria include the left and right atria. In this embodiment, the heart valve is a mitral or tricuspid valve.

[0052] In this embodiment, the self-expanding occlusion device 10 has: an elastic surface 101 extending circumferentially along axis A to form a hollow cavity 108; a first port 102 located at the proximal end of the elastic surface 101 and circumferentially surrounding axis A; and a second port 103 located at the distal end of the elastic surface 101 and circumferentially surrounding axis A. Axis A may be the centerline of the self-expanding occlusion device 10, and the material of the elastic surface 101 may be a human-acceptable elastic material.

[0053] The first port 102, the inner cavity 108, and the second port 103 are interconnected, and the opening area of ​​the second port 103 is larger than the opening area of ​​the first port 102. The shapes of the first port 102 and the second port 103 can be circular, elliptical, or other regular or irregular shapes, and the opening area is the area of ​​the port. When both the first port 102 and the second port 103 are circular, the ratio of the opening areas of the first port 102 to the second port 103 is the ratio of the diameters of the first port 102 and the second port 103.

[0054] See Figure 4 and Figure 5 Taking the mitral valve as an example, when the blood pressure in the left ventricle pushes the anterior and posterior leaflets of the mitral valve to close (e.g.) Figure 4 As shown, blood flowing from the left ventricle to the left atrium is reversed by the mitral valve, causing the pressure at the second port 103 to be greater than that at the first port 102. This creates a first pressure difference in the lumen 108, which in turn causes blood to flow into the lumen 108 from the second port 103. Simultaneously, because the opening area of ​​the second port 103 is larger than that of the first port 102, the volume of blood flowing into the lumen 108 from the second port 103 is much greater than the volume of blood flowing out of the lumen 108 from the first port 102. In other words, the blood flow rate at the second port 103 is much greater than that at the first port 102, causing the self-expanding body to expand more rapidly. A small amount of blood flowing out from the first port 102 can cause a small amount of backflow, making thrombus formation less likely. The design of the openings at the second port 103 and the first port 102 ensures that backflow does not cause adverse effects on the heart, such as left atrial hypertrophy, while effectively reducing thrombus formation.

[0055] When the blood pressure in the left atrium pushes the valve leaflets open, blood flows from the left atrium to the left ventricle. The pressure at the first port 102 is greater than the pressure at the second port 103, creating a second pressure difference in the inner cavity 108. This second pressure difference causes some blood to flow out of the inner cavity 108 from the second port 103, while some blood flows into the inner cavity 108 from the first port 102. Simultaneously, some blood flows from the first port 102 to the second port 103 outside the elastic surface 101, compressing the elastic surface 101 and causing the blood in the inner cavity 108 to flow out rapidly, thus causing the self-expanding body to contract. Because the opening area of ​​the first port 102 is smaller than that of the second port 103, this accelerates the flow rate of some blood from the first port 102 to the second port 103 outside the elastic surface 101.

[0056] In one embodiment, the ratio of the opening area of ​​the second port 103 to the opening area of ​​the first port 102 is 2:1 to 10:1. In another embodiment, the ratio is 2:1 to 6:1. The aforementioned ratio of the opening area of ​​the second port 103 to the opening area of ​​the first port 102 was determined by the inventors through extensive experimentation. A ratio that is too small or too large will prevent the elastic surface 101 from expanding and contracting rapidly.

[0057] Please refer to Figures 1 to 3 In one embodiment of this application, the first port 102 is provided with a first fixing ring 104, which is connected to the elastic surface 101 to define the shape of the first port 102, so as to ensure that the proximal end of the self-expanding occlusion device 10 has a stable flow area; the second port 103 is provided with a second fixing ring 105, which is connected to the elastic surface 101 to define the shape of the second port 103, so as to ensure that the distal end of the self-expanding occlusion device 10 has a stable flow area. By adjusting the relative distance between the first fixing ring 104 and the second fixing ring 105, the size of the expansion of the elastic surface 101 and the position of the elastic surface 101 aligning with the valve can be adjusted. For example, reducing the vertical distance between the first fixing ring 104 and the second fixing ring 105 can increase the size of the expansion of the elastic surface 101; the simultaneous upward or downward movement of the first fixing ring 104 and the second fixing ring 105 can change the position of the elastic surface 101 aligning with the valve.

[0058] Please refer to Figure 2 and Figure 6The self-expanding occlusion device 10 further includes an anchoring unit 106, comprising: a connector 107 passing through the first port 102, the lumen 108, and the second port 103; a first anchoring member 109 connected to the proximal end of the connector 107 for anchoring to the atrium; and a second anchoring member 110 connected to the distal end of the connector 107 for anchoring to the ventricle. The connector 107 can be a guidewire or other structure. Figure 3 As shown, the second anchor 110 can be a spiral structure that can be screwed into the ventricular wall. Figure 9 As shown, the second anchor 110 can also be a rivet structure, with the rivet passing through the ventricular wall and fixed to the inner and outer walls of the ventricle. Of course, the first anchor 109 and the second anchor 110 are not limited to the above forms, and can be any other suitable structure.

[0059] refer to Figure 1 and Figure 3 The first port 102 is provided with a first fixing member 111, which is connected to the connector 107; the second port 103 is provided with a second fixing member 112, which is connected to the connector 107. This design can effectively stabilize the shape of the first port 102 and the second port 103 to resist the deformation caused by the impact of blood.

[0060] refer to Figure 2 The anchoring unit 106 also has a safety helmet 113 that covers the second anchor 110 to reduce blood flow to the second anchor 110 and nearby tissues to prevent tissue tearing.

[0061] like Figure 6 As shown, the elastic surface 101 can be a relatively hard material that forms a cylindrical shape when it expands.

[0062] like Figure 8 As shown, the elastic surface 101 can also be made of a soft material, and its shape and size when expanded are automatically adjusted according to the gap when the valve opens and closes.

[0063] refer to Figure 10 and Figure 11In this embodiment, the self-expanding occlusion device 10 is implanted between the aortic valves. Unlike the embodiments described above, when the self-expanding occlusion device 10 is implanted into the aortic valve, the second port faces the aorta, and the first port faces the left ventricle. During left ventricular diastole, the aortic blood return pushes the aortic valve to close, creating a first pressure difference between the second port and the first port within the lumen. Simultaneously, because the opening area of ​​the second port 103 is larger than that of the first port 102, the volume of blood flowing into the lumen 108 from the second port 103 is much greater than the volume of blood flowing out of the lumen 108 from the first port 102; that is, the blood flow rate at the second port 103 is much greater than the blood flow rate at the first port 102, thus causing the self-expanding device to expand more rapidly. During left ventricular systole, The pressure of blood in the left ventricle pushes the aortic valve open, and the pressure at the first port 102 is greater than the pressure at the second port 103, thus creating a second pressure difference in the lumen 108. This second pressure difference causes some blood to flow out of the lumen 108 from the second port 103, while some blood flows into the lumen 108 from the first port 102. Simultaneously, some blood flows from the first port 102 to the second port 103 outside the elastic surface 101, compressing the elastic surface 101 and causing the blood in the lumen 108 to flow out rapidly, thus causing the self-expanding body to contract. Because the opening area of ​​the first port 102 is smaller than that of the second port 103, this accelerates the flow rate of some blood from the first port 102 to the second port 103 outside the elastic surface 101.

[0064] The operation principle of implanting a self-expanding occlusion device between the pulmonary valves of the heart is similar to that of implanting it into the aortic valve (not shown in the figure). That is, during the diastolic phase of the right ventricle, when the pulmonary blood return pushes the pulmonary valve to close, a first pressure difference is formed between the second port and the first port in the lumen, thereby causing blood to flow into the lumen from the second port, causing the self-expanding body to expand. During the systolic phase of the right ventricle, the right ventricular blood pressure pushes the pulmonary valve to open, and a second pressure difference is formed between the second port and the first port in the lumen. This second pressure difference causes some blood to flow out of the lumen from the second port, and some blood to flow into the lumen from the first port. At the same time, some blood flows from the first port to the second port outside the elastic surface, causing blood to flow out of the lumen, causing the self-expanding body to contract.

[0065] In summary, the self-expanding occlusion device of this application has a simple structure, is easy to manufacture, and cleverly combines its structure with the blood flow during cardiac systole and diastole. For patients with valvular regurgitation, the self-expanding occlusion device can work in conjunction with the original valve during systole to effectively resolve blood regurgitation, effectively sealing the gap when the valve closes. During diastole, it reduces obstruction to blood flow channels. These channels include those between the left atrium and left ventricle, the right atrium and right ventricle, the aortic valve and left ventricle, and the pulmonary valve and right ventricle.

[0066] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of this application, and are not intended to limit them; although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A self-expanding occlusion device for implantation between valve structures, including atrioventricular valves, aortic valve of the heart and pulmonary valve of the heart, characterized in that, The device comprises a self-expanding body having: a flexible surface extending circumferentially along an axis A, forming a hollow inner cavity; a first port provided at a proximal end of the flexible surface, and the first port circumferentially surrounds the axis A; and a second port provided at a distal end of the flexible surface, and the second port circumferentially surrounds the axis A; the first port, the inner cavity and the second port are in communication with each other, the size of the second port is greater than the size of the first port, so that when the corresponding ventricle, aorta or pulmonary artery blood pushes the corresponding valve to close, the second port and the first port form a first pressure difference in the inner cavity, thereby causing blood to flow from the second port into the inner cavity, expanding the self-expanding body; when the corresponding atrium, left ventricle or right ventricle blood pushes the valve to open, the second port and the first port form a second pressure difference in the inner cavity, the second pressure difference causes part of the blood to flow out of the inner cavity from the second port, part of the blood to flow into the inner cavity from the first port, and part of the blood to flow from the first port to the second port outside the flexible surface, causing the blood in the inner cavity to flow out, causing the self-expanding body to contract. The ratio of the opening area of the second port to the opening area of the first port is 2:1 to 10:

1.

2. The self-expanding occlusion device of claim 1, wherein, The first port is provided with a first fixing ring connected with the flexible surface for defining the shape of the first port; and the second port is provided with a second fixing ring connected with the flexible surface for defining the shape of the second port.

3. The self-expanding occlusion device of claim 1, wherein, The self-expanding occlusion device further comprises an anchoring unit having:

4. The self-expanding occlusion device of claim 1, wherein, a connecting member passing through the first port, the inner cavity and the second port; a first anchor connected to a proximal end of the connecting member; and a second anchor connected to a distal end of the connecting member. The first port is provided with a first fixing member connected with the connecting member; and the second port is provided with a second fixing member connected with the connecting member.

5. The self-expanding occlusion device of claim 4, wherein, The anchoring unit further has a safety cap covering the second anchor to reduce blood flushing the tissue near the second anchor.

6. The self-expanding occlusion device of claim 4, wherein, The flexible surface forms a cylindrical shape when inflated.

7. The self-expanding occlusion device of claim 1, wherein, The flexible surface is composed of a soft material, and the shape and size of the inflated flexible surface are automatically adjusted according to the gap when the valve is opened and closed.

8. The self-expanding occlusion device of claim 1, wherein, ​

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