A balloon-expandable interventional valve stent with an inward-retracted wingspan skirt

Abstract

The present invention discloses a balloon expandable interventional valve stent with an inward-retracted wingspan skirt, comprising a stent body, a valve leaf and a wingspan skirt, wherein the wingspan skirt is arranged outside the outflow channel, and a plurality of circular holes are evenly arranged at the edge position of the wingspan skirt close to the outflow channel side, and a traction suture is connected to the wingspan skirt, one side of the traction suture is connected to the wingspan skirt, and the other side is connected to the skirt on the inflow channel side, and when the balloon is expanded and opened, the traction suture in the skirt connected to the inflow channel side is gradually tightened along the circumferential direction under the action of the balloon expansion force, so that the traction suture in the wingspan skirt is tensioned, causing the wingspan skirt to be folded toward the outside of the inflow channel along the axis direction of the stent, forming a part protruding outward in the radial direction of the stent body, thereby covering or blocking paravalvular leakage. The present invention makes full use of the structure of the outflow channel, increases the wing span skirt structure that can be used without increasing the diameter of the delivery system, and greatly improves the blocking effect of paravalvular leakage. And because a flexible non-metallic material is used, the additional structure will not increase damage to the heart.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to a balloon-expandable interventional valve stent with an inward-retracted wing skirt, which can be used in scenarios such as the aortic valve, pulmonary valve, mitral valve and tricuspid valve positions, as well as the valve-in-valve of a damaged biological valve. Background Art

[0002] Paravalvular leak (PVL), that is, the formation of a leak between the artificial valve and the surrounding tissue, is a common and serious complication in all heart valve surgeries. In particular, the incidence is extremely high in the increasingly mainstream transcatheter valve treatment. Many studies have shown that postoperative paravalvular leak is directly related to the patient's recovery, reoperation rate, re-hospitalization rate, and early, medium and long-term mortality. The results of a meta-analysis of multiple international studies showed that only 6-59% of patients did not have paravalvular leak after transcatheter aortic valve intervention. The reasons for this are not only the inability to remove the patient's original degenerated, decayed, and damaged valve, the patient's own anatomical structure, and factors such as the non-circular plane of the valve ring, but also have a lot to do with the design characteristics of the current transcatheter valve intervention surgical equipment. With the popularization of transcatheter technology around the world, more and more patients, and younger and younger patients, will choose transcatheter valve surgery for treatment, and the emergence of new transcatheter valve intervention surgical equipment is imperative.

[0003] Currently available balloon-expandable interventional valves usually have a skirt on the outside of the inflow channel, such as the artificial valve structure disclosed in patent document CN108430394A. Such a structural design is based on many years of clinical experience, and it is believed that paravalvular leakage can be improved by increasing the contact area with the heart valve ring plane. However, the existing valve structure still has problems. Since the size of the valve delivery system cannot be too large, the skirt cannot be thickened unlimitedly, so the effect of preventing paravalvular leakage is limited. Therefore, an interventional valve that can prevent paravalvular leakage without increasing the size of the valve delivery system is needed. Summary of the invention

[0004] Therefore, the purpose of the present invention is to provide a balloon-expandable interventional valve stent with an inward-retracted wing-span skirt. The inward-retracted wing-span skirt is arranged in the outflow path of the stent through a unique design, and the wing-span skirt can extend radially outward from the stent to cover and block paravalvular leakage, thereby preventing adverse consequences caused by paravalvular leakage.

[0005] The present invention is achieved through the following technical solutions:

[0006] The present invention provides a balloon-expandable interventional valve stent with an inward-retracted wingspan skirt, comprising a stent body, a valve leaf and a wingspan skirt, wherein the stent body comprises an inflow channel located at a lower portion and an outflow channel located at an upper portion, the wingspan skirt is arranged on the outer side of the outflow channel, the side edge of the wingspan skirt close to the middle portion of the stent body is fixedly connected to the stent, and the other parts of the wingspan skirt are not fixedly connected to the stent body, and the surface of the wingspan skirt is attached to the surface of the stent body; a skirt is also arranged on the inflow channel side of the stent body; a traction suture is connected to the wingspan skirt, one side of the traction suture is connected to the wingspan skirt, and the other side is connected to the skirt on the inflow channel side, and the traction suture is connected to the wingspan skirt. The sutures are reciprocatingly connected between the wing span skirt and the skirt on the inflow channel side for multiple times; when the balloon is expanded and opened, the two ends of the stent body are opened first, and then the middle part of the stent body is opened, and when the stent body located on the inflow channel side is opened, the skirt located on the inflow channel side is unfolded accordingly, and the traction sutures connected to the skirt on the inflow channel side are gradually tightened along the circumferential direction under the action of the balloon expansion force, so that the traction sutures in the wing span skirt on the outflow channel side are tensioned, and the tensioned traction sutures cause the wing span skirt to be folded toward the outside of the inflow channel along the axial direction of the stent body, forming a part protruding outward in the radial direction of the stent body, thereby covering or blocking paravalvular leakage.

[0007] According to the valve support of the present invention, a plurality of circular holes are evenly arranged at the edge of the wing skirt close to the outflow channel side, and the number of the circular holes is an even number.

[0008] According to the valve stent of the present invention, the traction suture is in a continuous shape of multiple "J" as a whole, and a plurality of connection points are arranged at intervals on the skirt on the inflow side to connect the traction suture. The traction suture passes through the connection points and the circular holes in sequence in the order of "connection point-circular hole-circular hole-connection point". When the traction suture is tensioned, the wing span skirt on the outflow side is folded toward the outside of the inflow side along the axial direction of the stent.

[0009] According to the valve stent of the present invention, the number of the pulling sutures is 1, 2, 3, 4, 6 or 12, preferably 1, which continuously passes through the circular hole in the wingspan skirt and multiple connection points of the skirt on the inflow channel side.

[0010] According to the valve stent described in the present invention, when there are more than two pulling sutures, the above two or more pulling sutures have equal lengths, are connected end to end at the connection point of the skirt on the inflow side, and together cover the entire circumference of the wingspan skirt.

[0011] According to the valve stent of the present invention, the wingspan skirt and the pulling suture are both made of flexible non-metallic materials.

[0012] According to the valve stent of the present invention, the pulling suture is made of a polymer material, preferably polyglycolic acid, polylactic acid or polydioxanone.

[0013] Beneficial effects of the present invention:

[0014] The advantages of the present invention are that it makes full use of the structure of the outflow tract and increases the available wing skirt structure without increasing the diameter of the delivery system. For paravalvular leakage, such as non-elliptical heart valve rings, the wing skirt can provide a better blocking effect than the current existing technology. And because flexible non-metallic materials are used, the additional structure will not increase damage to the heart. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 A schematic diagram of a compressed and gripped state of a balloon-expandable interventional valve stent according to an embodiment of the present invention;

[0016] Figure 2 A schematic diagram of the expansion process of a balloon-expandable interventional valve stent according to an embodiment of the present invention;

[0017] Figure 3 A schematic diagram of an expanded state of a balloon-expandable interventional valve stent according to an embodiment of the present invention;

[0018] Figure 4 A schematic diagram of a traction suture of a balloon-expandable interventional valve stent according to an embodiment of the present invention;

[0019] Figure 5 A front view of the effect diagram of the balloon-expandable interventional valve stent of the present invention;

[0020] Figure 6 A top view of the rendering of the balloon-expandable interventional valve stent of the present invention. DETAILED DESCRIPTION

[0021] The present invention will be further described below in conjunction with specific embodiments. It should be understood that the embodiments are only used to illustrate the present invention and are not intended to limit the scope of protection of the present invention. In addition, it should be understood that after reading the contents disclosed in the present invention, those skilled in the art may make various changes or modifications to the present invention, and these equivalent forms also fall within the scope of protection defined by the present invention.

[0022] like Figure 1-3As shown, a balloon expandable interventional valve stent includes a stent body 1, a valve leaflet (not shown) and a wing skirt 2. The stent body 1 includes an inflow channel 3 located at the lower part and an outflow channel 4 located at the upper part. The wing skirt 2 is arranged outside the outflow channel 4. The side of the wing skirt 2 close to the middle of the stent body 1 is fixedly connected to the stent body 1, and the other parts are not fixed. The surface of the wing skirt 2 is attached to the surface of the stent body 1. A plurality of circular holes 8 are evenly arranged at the side edge of the wing skirt 2 close to the outflow channel, and the number of the circular holes is an even number. A traction suture 5 is connected to the wing skirt 2.

[0023] The inflow channel side of the stent body 1 is also provided with a skirt (not shown in the figure), and a plurality of connection points 6 are arranged at intervals on the skirt on the inflow channel side to connect the pulling sutures 5. The pulling sutures 5 are in a continuous plurality of "J" shapes, and pass through each connection point 6 and the circular hole 8 in sequence in the order of "connection point-circular hole-circular hole-connection point". There can be a plurality of pulling sutures, such as 1, 2, 3, 4, 6 or 12, preferably 1, which continuously passes through the circular hole 8 in the wingspan skirt and the plurality of connection points 6 of the outer skirt on the inflow channel side. When there are more than two pulling sutures, the above-mentioned more than two pulling sutures 5 have equal lengths to each other, are connected end to end at the connection point 6, and jointly cover the entire circumference of the wingspan skirt 2.

[0024] When the balloon 7 is expanded and opened, the two ends of the stent body 1 are opened first, and then the middle part of the stent body 1 is opened. When the stent body 1 located on the inflow channel side is opened, the skirt located on the inflow channel side is unfolded accordingly, and the traction suture 5 connected to the skirt on the inflow channel side is gradually tightened along the circumferential direction under the action of the balloon expansion force, so that the traction suture 5 in the wing skirt 2 on the outflow channel side is tensioned, causing the wing skirt 2 on the outflow channel side to be folded toward the outside of the inflow channel along the axial direction of the stent body 1. The folded wing skirt presents a protruding part outward in the radial direction of the stent body 1 under the joint action of the balloon expansion force and the tensioning force of the traction suture. The skirt part protruding outward in the radial direction can cover and block the paravalvular leakage, and the whole constitutes an inward-retracted wing skirt 2. The wing skirt 2 is made of a flexible non-metallic material, and the traction suture 5 can be made of a polymer material such as polyglycolic acid, polylactic acid or polydioxanone.

[0025] Depend on Figure 5 and Figure 6 It can be seen that the technical solution of the present invention makes full use of the structure of the outflow tract, and increases the available wing-span skirt structure without increasing the diameter of the delivery system. The wing-span skirt structure of the present invention can greatly improve the blocking effect of paravalvular leak. And because flexible non-metallic materials are used, the additional structure will not increase damage to the heart.

[0026] The above is an explanation of the embodiments of the present invention. However, the present invention is not limited to the above embodiments. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A balloon-expandable interventional valve stent with an inward-spanning skirt, characterized in that: It includes a stent body, leaflets, and a flared skirt. The stent body includes an inflow tract at the lower part and an outflow tract at the upper part. The flared skirt is arranged outside the outflow tract. The side of the flared skirt close to the middle of the stent body is fixedly connected to the stent. The other parts of the flared skirt are not fixedly connected to the stent body. The surface of the flared skirt adheres to the surface of the stent body. A skirt is also provided on the inflow tract side of the stent body. A pulling suture is connected to the flared skirt. One side of the pulling suture is connected to the flared skirt, and the other side is connected to the skirt on the inflow tract side. The pulling suture is reciprocally connected multiple times between the flared skirt and the skirt on the inflow tract side. A number of round holes are evenly arranged at the edge position of the flared skirt close to the outflow tract side. The number of the round holes is an even number. The pulling suture is integrally in the shape of a continuous plurality of "Z" shapes. A plurality of connection points are arranged at intervals on the skirt on the inflow tract side to connect the pulling suture. The pulling suture sequentially passes through the connection points and the round holes in the order of "connection point - round hole - round hole - connection point". When the balloon expands and opens, the two ends of the stent body open first, and then the middle of the stent body opens. When the stent body on the inflow tract side opens, the skirt on the inflow tract side unfolds accordingly. The pulling suture in the skirt on the inflow tract side is gradually tightened along the circumferential direction under the action of the balloon expansion force, so that the pulling suture in the flared skirt on the outflow tract side is tightened. The tightened pulling suture causes the flared skirt to fold outward along the axial direction of the stent body to the outside of the inflow tract, forming a part protruding outward in the radial direction of the stent body, thereby covering or blocking the paravalvular leak.

2. A balloon-expandable interventional valve stent with an inward-retracted wingspan skirt according to claim 1, characterized in that: The pulling suture is 1, 2, 3, 4, 6, or 12, and continuously passes through the round holes in the flared skirt and the multiple connection points of the skirt on the inflow tract side.

3. A balloon-expandable interventional valve stent with an inward-retracted wingspan skirt according to claim 2, characterized in that: When there are more than 2 pulling sutures, the above-mentioned more than 2 pulling sutures have equal lengths, and are connected end to end at the connection points of the skirt on the inflow tract side, jointly covering the entire circumference of the flared skirt.

4. A balloon-expandable interventional valve stent with an inward-retracted wingspan skirt according to claim 3, characterized in that: Both the flared skirt and the pulling suture are made of flexible non-metallic materials.

5. A balloon-expandable interventional valve stent with an inward-retracted wingspan skirt according to claim 4, characterized in that: The pulling suture is made of a polymer material.

6. A balloon-expandable interventional valve stent with an inward-retracted wingspan skirt according to claim 5, characterized in that: The pulling suture is made of polyglycolic acid, polylactic acid, or poly-p-dioxanone.

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