Valve stent and prosthetic valve

Abstract

The application provides a valve stent and artificial valve, which comprises a stent body, a plurality of first support arms arranged along the circumference of the stent body, one end of the first support arm being connected with the outflow end of the stent body, the other end being arranged outside the stent body and extending towards the inflow end of the stent body, and a second support arm, one end of the second support arm being connected with the outflow end of the stent body, the other end being arranged outside the stent body; the stent body can be placed at the aortic valve, the stent body and the first support arm accommodate the native valve leaflet, the other end of the first support arm extends into the corresponding aortic sinus to provide anchoring, at least one first support arm can be arranged in each aortic sinus, and the second support arm can support the aortic wall. The application can replace the aortic valve regurgitation, realize stable and reliable anchoring through the unique anchoring structure, and is not easy to block the coronary artery opening.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve stent and an artificial valve for pure aortic regurgitation valve replacement. Background Art

[0002] The heart contains four chambers: the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV). Throughout the cardiac cycle, the pumping action of the left and right sides of the heart generally occurs synchronously. The valves separating the atria from the ventricles are called the atrioventricular valves. They act as one-way valves, ensuring the normal flow of blood within the heart chambers. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery, from where it flows to the lungs; blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta, from where it flows to the pericardium. There are typically no direct connections between the ventricles or between the atria. At the beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the atrioventricular valves open to allow unimpeded flow from the atria into the corresponding ventricles. Shortly after the onset of ventricular systole (i.e., when the ventricles empty), the tricuspid and mitral valves normally close, forming a seal that prevents backflow from the ventricles into the corresponding atria. The failure of the valve leaflets to seal during ventricular systole is called malcoaptation and can allow blood to flow backward through the valves (regurgitation). Heart valve insufficiency can have serious consequences for patients, often leading to heart failure, decreased blood flow, lowered blood pressure, and / or decreased oxygen flow to the body's tissues. Aortic valve insufficiency can also cause blood to flow back from the left atrium into the pulmonary veins, causing congestion. Severe valvular insufficiency, if left untreated, can lead to permanent disability or death.

[0003] In recent years, transcatheter aortic valve replacement (TAVR) has developed rapidly and its position in the treatment of aortic stenosis (AS) has gradually improved. It is also used to treat specific AR patients, and relevant recommendations have been made in domestic and foreign guidelines. Unlike Western countries, in China, the number of AR patients is not less than that of AS patients. According to the China-DVD study data: researchers conducted the first nationwide survey for elderly patients with valvular heart disease from September to December 2016, and nearly 9000 patients over 60 years old were selected from 69 hospitals in 28 provinces, municipalities and autonomous regions. Among them, the proportion of patients with pure aortic regurgitation (PAR) was 10.2%, and the proportion of patients with AS was 5.1%. In patients with severe valvular disease, the proportion of AR and AS patients is similar. Although TAVR has developed rapidly, it is still difficult to use in patients with pure aortic regurgitation (PAR) who are surgically contraindicated or high-risk, and in patients with PAR who have suitable anatomical structure, because most PAR patients have a larger valve ring and severe aortic dilation, which cannot be closed easily and is prone to cause regurgitation and device-related thrombosis. This part of the patient's ventricle is larger, the stroke volume increases, the hemodynamic impact is large, and the valve leaflet has no calcification or has a small amount of calcification, making anchoring more difficult. The existing technology does not consider the impact on coronary blood flow dynamics when treating pure aortic regurgitation, which easily blocks the coronary artery opening.

[0004] It should be noted that the information disclosed in the background section of the present application is only intended to deepen the understanding of the general background of the present application, and should not be regarded as acknowledging or implying in any form that the information constitutes prior art known to those skilled in the art. SUMMARY

[0005] In view of the defects of the prior art, the present application provides a valve stent and artificial valve for replacing pure aortic regurgitation valve, which can realize stable and reliable anchoring through a unique anchoring structure and does not block the coronary artery opening.

[0006] To achieve the above-mentioned purpose, the present application provides a valve stent, which comprises:

[0007] a stent body;

[0008] a plurality of first support arms, the plurality of first support arms being arranged along the circumference of the stent body, one end of each of the first support arms being connected to the outflow end of the stent body, and the other end of each of the first support arms being arranged outside the stent body and extending towards the inflow end of the stent body; and

[0009] at least one second support arm, one end of the second support arm being connected to the outflow end of the stent body, and the other end of the second support arm being arranged outside the stent body.

[0010] The stent body is used to be placed at the aortic valve, and the stent body and the first support arm are used to accommodate the native valve leaflet, and the other end of each first support arm is used to extend into the corresponding aortic sinus to provide anchoring. At least one first support arm is used to be set in each aortic sinus, and the second support arm is used to support the aortic wall.

[0011] Preferably, the number of the first support arms is three, and one first support arm is provided in each aortic sinus.

[0012] Preferably, the second support arm can be released from the conveying system before the first support arm.

[0013] Preferably, the second support arm and the first support arm at least partially overlap in the circumferential direction of the bracket body, or the second support arm and the first support arm do not overlap in the circumferential direction of the bracket body.

[0014] Preferably, the first support arm and the second support arm are staggered in upper and lower layers along the axial direction of the bracket body, or staggered in inner and outer layers along the radial direction of the bracket body.

[0015] Preferably, there are multiple second support arms, and the multiple second support arms are arranged along the circumference of the bracket body.

[0016] Preferably, the number of the second support arms is three.

[0017] Preferably, the radial dimension of the second support arm after expansion is greater than the radial dimension of the first support arm after expansion.

[0018] Preferably, the length of the first support arm is smaller than the length of the bracket body, and the length of the second support arm is smaller than the length of the first support arm.

[0019] Preferably, the other end of the first support arm is a rounded structure, and / or the other end of the second support arm is a rounded structure.

[0020] Preferably, the first support arm and the bracket body are integrally formed, or the first support arm and the bracket body are separately formed and connected.

[0021] Preferably, the second support arm and the bracket body are integrally formed, or the second support arm and the bracket body are separately formed and connected.

[0022] Based on the same inventive concept, the present invention also provides an artificial valve, which is provided with any one of the valve stents described.

[0023] The above-mentioned valve stent includes: a stent body; a plurality of first support arms, which are arranged along the circumference of the stent body, one end of each first support arm is connected to the outflow end of the stent body, and the other end of each first support arm is arranged on the outside of the stent body and extends toward the inflow end of the stent body; and at least one second support arm, one end of the second support arm is connected to the outflow end of the stent body, and the other end of the second support arm is arranged on the outside of the stent body; the stent body is used to be placed at the aortic valve, and the space between the stent body and the first support arm is used to accommodate the native leaflet, and the other end of each first support arm is used to extend into the corresponding aortic sinus to provide anchoring, and at least one first support arm is used to be arranged in each aortic sinus, and the second support arm is used to support the aortic wall.

[0024] With this configuration, when replacing a pure aortic regurgitation valve, the present invention can provide a strong anchoring force through the first and second support arms, enabling valve replacement for patients with pure aortic regurgitation, where anchoring is difficult, and achieving stable and reliable anchoring. Furthermore, the present invention can prevent the valve stent from interfering with and blocking the coronary artery opening through the second support arm, thereby avoiding any impact on coronary hemodynamics. Furthermore, during delivery, after the aortic wall is propped open, space is provided for subsequent operations, reducing the difficulty of subsequent operations and ensuring accurate and reliable positioning.

[0025] Since the artificial valve provided in this application and the valve stent provided in this application belong to the same inventive concept, the artificial valve provided in this application has all the advantages of the valve stent provided in this application, so the beneficial effects of the artificial valve provided in this application will not be described one by one here. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0027] Figure 1 Schematic diagram of the overall structure of a valve stent provided according to one embodiment of the present invention.

[0028] Figure 2 It is a schematic diagram of the partial structure of a valve stent provided according to one embodiment of the present invention.

[0029] Figure 3 This is a schematic diagram of the structure of the valve stent when viewed from the outflow end to the inflow end according to one embodiment of the present invention.

[0030] Figure 4It is a schematic diagram of a scenario in which a valve stent is placed at a native aortic valve in vivo according to one embodiment of the present invention.

[0031] Figure 5 This is a diagram of a process for replacing a pure aortic regurgitation valve by delivering an artificial valve through a delivery system according to one embodiment of the present invention.

[0032] The following are the descriptions of the reference numerals:

[0033] 11-native valve leaflet; 12-coronary artery opening; 100-valve stent; 110-stent body; 111-inflow end; 112-outflow end; 120-first support arm; 121-the other end of the first support arm; 130-second support arm; 131-the other end of the second support arm; 140-delivery connection; 200-delivery system; 201-delivery head; 202-delivery catheter; 203-delivery sheath. DETAILED DESCRIPTION

[0034] To make the objects, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and are not in exact proportions, and are only used to conveniently and clearly assist in illustrating the purpose of the embodiments of the present invention.

[0035] As used herein, "top" and "bottom" are used in relation to the direction of blood flow through the prosthetic valve. Although "top" and "bottom" are not intended to be limiting, "bottom" generally refers to the end closest to where blood flows into the prosthetic valve, while "top" generally refers to the end closest to where blood flows out of the prosthetic valve. As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the context clearly indicates otherwise. As used in this specification, the term "or" is generally used in the sense of including "and / or," unless the context clearly indicates otherwise. In addition, the term "radial" refers to a direction perpendicular to the axis of the prosthetic valve or valve support; "axial" refers to a direction parallel to the axis of the prosthetic valve or valve support; "circumferential" refers to a direction around the axis of the prosthetic valve or valve support; "inner" refers to the side closer to the axis of the prosthetic valve or valve support; and "length" refers to the dimension along the axial direction of the valve support. "One end" and "the other end" in this application document do not refer to the ends of the structure, but to relative positions.

[0036] The purpose of the present invention is to provide a valve stent and an artificial valve thereof, which are suitable for replacing a simple aortic regurgitation valve, so as to solve the problems of the prior art in treating pure aortic valve regurgitation, such as anchoring difficulty, anchoring instability, and influence on coronary artery hemodynamics.

[0037] The artificial valve provided by the present application can be delivered through the heart apex, through the femoral artery or through other paths, and the present application is not limited in this regard.

[0038] The following is described with reference to the drawings.

[0039] Please refer to Figures 1 to 4 In the embodiment of the present application, a valve stent 100 is provided, which comprises a stent body 110 and a first support arm 120 and a second support arm 130 connected to the stent body 110. The stent body 110 is located inside the first support arm 120 and the second support arm 130.

[0040] The stent body 110 has opposite inflow end 111 and outflow end 112. According to the normal direction of blood flow, the inflow end 111 refers to the position where blood flows into the valve stent 100, which is also the end of the valve stent 100 close to the left ventricle, and the position corresponding to the inflow end 111 is the inflow tract of the valve stent 100; while the outflow end 112 refers to the position where blood flows out of the valve stent 100, which is also the end of the valve stent 100 away from the left ventricle, and the position corresponding to the outflow end 112 is the outflow tract of the valve stent 100. The outflow tract is located downstream of the inflow tract, and if viewed from the direction of blood flow, the outflow tract is located on the right side of the inflow tract. Figure 1 As viewed from the direction shown in the figure, the outflow end 112 is the top end of the stent body 110, and the inflow end 111 is the bottom end of the stent body 110, and the direction from the inflow end 111 to the outflow end 112 is the axial direction of the valve stent 100.

[0041] The stent body 110 is woven or cut, preferably cut, for example, laser engraved. The stent body 110 is a three-dimensional mesh structure, which is usually configured in a cylindrical shape. The stent body 110 usually adopts a diamond mesh and is responsible for carrying artificial valve leaflets, skirts and other structures, and the artificial valve leaflets and skirts are both prior art. The material for preparing the stent body 110 is not particularly limited, for example, it can be made of nickel-titanium alloy or other biocompatible materials with shape memory properties, or it can be made of materials with elastic or plastic deformation, such as balloon expandable materials. Preferably, the stent body 110 is made of nickel-titanium alloy.

[0042] The number of the first support arms 120 is three or more than three, and the more suitable number is three. Three first support arms 120 are sufficient to provide stable anchoring. In the present invention, the first support arms 120 are at least partially arranged on the outside of the bracket body 110, and a plurality of first support arms 120 are arranged along the circumference of the bracket body 110. Preferably, a plurality of first support arms 120 are evenly arranged along the circumference of the bracket body 110 to make the force more uniform and the anchoring more stable. One end of each first support arm 120 is connected to the outflow end 112 of the bracket body 110, and the other end 121 of each first support arm 120 extends outside the bracket body 110 toward the inflow end 111, that is, the other end 121 of the first support arm 120 faces the inflow end 111. The length of the other end 121 of the first support arm 120 extending toward the inflow end 111 can be set according to the depth of the aortic sinus, ensuring that the first support arm 120 can extend into the aortic sinus and contact the bottom of the aortic sinus, and that the native valve leaflet 11 can be accommodated between the first support arm 120 and the stent body 110. Generally, the length of the first support arm 120 is shorter than the length of the stent body 110 to facilitate sealing and prevent internal leakage.

[0043] It should be understood that the aortic valve is composed of three semilunar valves. The aortic wall corresponding to each semilunar valve bulges slightly, forming an upward-opening cavity called the aortic sinus, which are the left sinus, right sinus and posterior sinus respectively. The left and right coronary arteries open in the left sinus and right sinus respectively.

[0044] Reference Figure 4 As shown, when replacing a simple aortic regurgitation valve, the stent body 110 is positioned at the native aortic valve, with the native valve leaflets 11 accommodated between the stent body 110 and the first support arms 120. The other end 121 of each first support arm 120 extends into the corresponding aortic sinus to provide anchoring, and at least one first support arm 120 is provided in each aortic sinus. In this way, the other end 121 of the first support arm 120 can be positioned and supported within the aortic sinus, providing a strong anchoring force and effectively preventing the valve stent 100 from moving in the axial direction.

[0045] It should also be noted that one or more first support arms 120 may be provided in each aortic sinus, but preferably only one first support arm 120 is provided. Specifically, in this embodiment, the number of first support arms 120 is the same as the number of aortic sinuses, that is, three first support arms 120 are used, and only one first support arm 120 is provided in each aortic sinus. This configuration simplifies the structure and makes intraoperative operation more convenient.

[0046] The number of the second support arms 130 is one or more, and a plurality includes two or more than two. Preferably, the number of the second support arms 130 is multiple, so that the second support arms 130 are not too large and can easily avoid the coronary artery opening 12. More preferably, the number of the second support arms 130 is three, and the three second support arms 130 can provide three-point support, thereby better supporting the aortic wall in the circumferential direction of the aorta. When the number of the second support arms 130 is multiple, the multiple second support arms 120 are arranged along the circumference of the stent body 110. More preferably, the multiple second support arms 120 are evenly arranged along the circumference of the stent body 110.

[0047] Reference Figure 1 As shown, one end of the second support arm 130 is connected to the outflow end 112 of the stent body 110, and the other end 131 of the second support arm 130 is disposed outside the stent body 110. Preferably, the second support arm 130 can be released from the delivery sheath 203 before the first support arm 120. In practice, the length of the second support arm 130 can be less than, equal to, or greater than the length of the first support arm 120. Preferably, the length of the second support arm 130 is less than the length of the first support arm 120 to facilitate the release of the second support arm 130 first.

[0048] Reference Figure 4 As shown, when replacing a simple aortic regurgitation valve, the second support arm 130 can prop open the aortic wall and leave blood flow space for the coronary artery opening 12 to avoid affecting the coronary artery hemodynamics. Of course, when performing aortic valve replacement, the first support arm 120 can also avoid the coronary artery opening 12. The role of the second support arm 130 is not limited to this. It can also provide positioning support to a certain extent, further increasing the stability and reliability of anchoring. Moreover, after propping open the aortic wall, it can also provide space for subsequent operations, reducing the difficulty of subsequent operations and ensuring the accuracy and reliability of positioning.

[0049] Preferably, the first support arm 120 is configured to clamp the native valve leaflet 11 to further increase the anchoring force. The first support arm 120 can clamp the native valve leaflet 11 using its own elastic force or the elastic force of the elastic member connected thereto.

[0050] The other end 121 of the first support arm 120 can form point contact, line contact, or surface contact with the bottom of the aortic sinus, preferably line contact or surface contact. Preferably, the other end 121 of the first support arm 120 is a smooth structure without protruding edges and corners, thereby reducing damage to internal tissues, skirts, and other structures.

[0051] The first support arm 120 is easy to fold and unfold, and can also switch between the folded state and the unfolded state. Before delivery, the valve stent 100 is loaded into the delivery system 200, and the valve stent 100 is delivered into the body through the delivery system 200. During delivery, the first support arm 120 is constrained by the delivery system 200 and is in a folded state. At this time, the first support arm 120 can be tightly attached to the outer wall of the stent body 110 without excessively increasing the delivery size. After leaving the delivery system 200, the first support arm 120 unfolds and forms a certain space with the outer wall of the stent body 110. This space is convenient for the first support arm 120 to explore the aortic sinus and can accommodate the native valve leaflet 11.

[0052] The first support arm 120 can be made of nickel-titanium alloy or other conventional biocompatible materials with shape memory properties. Preferably, the first support arm 120 is made of nickel-titanium alloy. The outer contour shape of the first support arm 120 is not particularly limited, that is, the present invention does not limit the specific shape of the first support arm 120. For example, in some embodiments, the first support arm 120 adopts a shape that matches the aortic sinus. In order not to make the structure too complicated, the first support arm 120 can adopt a V-shape, U-shape, C-shape or similar structure, which is also easy to fold and unfold, and the size is not too large. It should be noted that the first support arm 120 can also have other structural forms, and this application is applicable to them; in addition, in addition to the linear structure shown in the figure, the first support arm 120 also has other structural forms, such as a sheet structure or a mesh structure, and this application is also applicable to them, as long as the first support arm 120 is easy to fold and unfold and probe into the aortic sinus.

[0053] The first support arm 120 can be integrally formed with the support body 110, for example, by cutting and forming the first support arm 120 and the support body 110. When the first support arm 120 is integrally cut and formed, the net rod can be directly folded outward to form the first support arm 120. The first support arm 120 can also be separately formed and connected to the support body 110, for example, by welding, riveting, bonding, or other connection methods to the outflow end 112 of the support body 110.

[0054] The first support arm 120 and the second support arm 130 do not interfere with each other and can be released independently. The positions of the first support arm 120 and the second support arm 130 in the circumferential direction of the bracket body 110 can overlap, including partial overlap or full overlap. "Circumferential overlap" can be understood as, when the first support arm 120 is kept stationary, if the second support arm 130 is moved along the axial direction of the bracket body 110, the second support arm 130 can be moved to the position of the first support arm 120, and conversely, when the second support arm 130 is kept stationary, if the first support arm 120 is moved along the axial direction of the bracket body 110, the first support arm 120 can be moved to the position of the second support arm 130.

[0055] Although the figures illustrate that the first support arm 120 and the second support arm 130 overlap in the circumferential direction, it should be understood that in other embodiments, the first support arm 120 and the second support arm 130 do not overlap at all in the circumferential direction of the stent body 110, so that the first support arm 120 and the second support arm 130 are staggered in the circumferential direction of the stent body 110. "Staggered in the circumferential direction" can be understood as meaning that when the first support arm 120 is held stationary, if the second support arm 130 is moved axially along the stent body 110, the second support arm 130 cannot move to the position of the first support arm 120. Conversely, when the second support arm 130 is held stationary, if the first support arm 120 is moved axially along the stent body 110, the first support arm 120 cannot move to the position of the second support arm 130. Given that the aortic sinus and the coronary artery ostium 12 generally correspond to each other, the first support arm 120 and the second support arm 130 are preferably at least partially overlapped in the circumferential direction.

[0056] The first support arm 120 and the second support arm 130 can be staggered in layers up and down along the axial direction of the stent body 110, or staggered in layers in the radial direction of the stent body 110. In addition, the first support arm 120 and the second support arm 130 can also be staggered in layers along the circumference of the stent body 110, as long as they can be folded and unfolded without interfering with each other.

[0057] Preferably, the radial dimension of the second support arm 130 after expansion is greater than the radial dimension of the first support arm 120 after expansion, so that the second support arm 130 can effectively act on the aortic wall. In this embodiment, the radial dimension of the second support arm 130 after expansion is greater than the radial dimension of the first support arm 120 after expansion, and the length of the second support arm 130 is less than the length of the first support arm 120.

[0058] The area defined by the outer contour of the second support arm 130 may be greater than, equal to, or smaller than the area defined by the outer contour of the first support arm 120. In this embodiment, the area defined by the outer contour of the second support arm 130 is smaller than the area defined by the outer contour of the first support arm 120.

[0059] The second support arm 130 has greater overall strength than the first support arm 120, allowing it to smoothly support the aortic wall. The second support arm 130 is inherently elastic, and its other end 131 can form point, line, or surface contact with the aortic wall, preferably line or surface contact. Preferably, the other end 131 of the second support arm 130 is rounded, without protruding edges or corners, to minimize damage to the aortic wall.

[0060] The second support arm 130 is foldable and expandable, and can switch between the folded and expanded states. Similar to the first support arm 120, during delivery, the second support arm 130 is constrained by the delivery system 200 and is in a folded state. In this folded state, the second support arm 130 can be straightened for delivery, minimizing its size. After being released from the delivery system 200, the second support arm 130 automatically opens and pushes against the aortic wall, expanding the operating space while leaving room for blood flow in the coronary artery ostium 12.

[0061] The second support arm 130 can be made of nickel-titanium alloy or other conventional biocompatible materials with shape memory properties. Preferably, the second support arm 130 is made of nickel-titanium alloy. This application does not limit the shape of the second support arm 130; in addition to the exemplified V-, U-, or C-shaped structures, other structures may also be used, as long as the second support arm 120 can support the blood vessel wall in its location when deployed.

[0062] The second support arm 130 can be integrally formed with the support body 110. Preferably, the second support arm 130 and the support body 110 are cut and formed integrally. During the integral cutting and forming process, the net rod can be directly turned outward to form the second support arm 130. The second support arm 130 can also be formed separately from the support body 110 and connected thereto. For example, the second support arm 130 is connected to the outflow end 112 of the support body 110 by welding, riveting, bonding, or other connection methods.

[0063] like Figure 1 and Figure 2 As shown, in an exemplary embodiment, a plurality of delivery connection parts 140 are provided on the stent body 110, and the plurality of delivery connection parts 140 are distributed along the circumference of the stent body 110. Preferably, the plurality of delivery connection parts 140 are evenly distributed along the circumference of the stent body 110. The delivery connection part 140 is provided at the outflow end 112 of the stent body 110. Each delivery connection part 140 is used to be detachably connected to the delivery system 200 to ensure that the relative position of the artificial valve and the delivery system 200 remains unchanged when the artificial valve is loaded into the delivery system 200, released from the delivery system 200, and delivered in the body. There are usually no less than three delivery connection parts 140, and a more suitable number is three. It should be noted that there are many ways to structure the delivery connection part 140, and at least one of them can be selected to be implemented, which is explained exemplarily below.

[0064] like Figure 2 As shown, in one example, the delivery connection portion 140 is configured as a hanging ear that can be connected to the delivery catheter 202 (see FIG. Figure 5 ) is clamped to prevent the valve stent 100 from falling off during transportation. The hanging ear can be selected as a T-shaped structure, but is not limited to this.

[0065] Based on the same inventive concept, in one embodiment of the present invention, an artificial valve is also provided, comprising the valve stent 100 described in any embodiment, and also comprising an artificial valve leaflet (not shown). The artificial valve leaflet is disposed in the stent body 110. The artificial valve leaflet is made of animal pericardium or other biocompatible polymer materials. In the working state, the artificial valve leaflet replaces the native valve leaflet to achieve the function of opening and closing the blood channel.

[0066] Furthermore, the artificial valve may also include a skirt (not shown). The skirt covers the inner side of the stent body 110 to form an inner skirt, or covers the outer side of the stent body 110 to form an outer skirt, or the inner side of the stent body 110 is covered with an inner skirt, and the outer side is covered with an outer skirt. After the skirt is set, paravalvular leakage can be prevented, and it is better to ensure that the single channel of blood flows from the inflow end 111 of the stent body 110 to the outflow end 112 of the stent body 110. The skirt is made of pericardium or other biocompatible polymer materials, such as PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene) or other common materials.

[0067] The following further illustrates the delivery process of the artificial valve provided by the present invention by taking the femoral artery as an example.

[0068] The specific implementation process is as follows Figure 5 As shown in steps (a) to (d):

[0069] First, as Figure 5 In step (a), the delivery system 200 enters the aortic root via the femoral artery, and the position of the delivery system 200 can be adjusted to ensure better centering;

[0070] Then as Figure 5 In step (b), when the delivery system 200 approaches the aortic valve, the delivery sheath 203 is pushed forward so that the second support arm 130 pops out first to open the tissue and provide space for subsequent operations.

[0071] Then as Figure 5 In step (c), the delivery sheath 203 is continuously pushed forward to eject the first support arm 120. At this time, the bottom end of the stent body 110 is still restrained by the delivery sheath 203.

[0072] After confirming that the first support arm 120 is completely released, continue to push the delivery system 200 forward. After the bottom end of the stent body 110 passes over the aortic valve ring and the first support arm 120 enters the bottom of the aortic sinus, release the bottom end of the stent body 110 to allow the stent body 110 to fully expand and unfold, that is, anchoring is completed and the artificial valve begins to work.

[0073] Finally, if Figure 5In step (d), after anchoring is completed, the delivery system 200 is withdrawn, and the aortic valve replacement is completed.

[0074] It can be understood that the delivery system 200 includes a delivery head 201, a delivery catheter 202 and a delivery sheath 203. The distal end of the delivery catheter 202 is connected to the delivery head 201, the proximal end of the delivery catheter 202 is connected to the handle, the artificial valve is sleeved on the delivery catheter 202, and the delivery sheath 203 is slidably sleeved on the delivery catheter 202 along the axial direction of the delivery catheter 202. A accommodating space for compressing the artificial valve is formed between the delivery sheath 203 and the delivery catheter 202.

[0075] Before use, the artificial valve provided by the present invention is stored between the delivery sheath 203 and the delivery catheter 202, so that the artificial valve can smoothly pass through the body structure during delivery; the handle is located outside the body. During use, the delivery system 200 is first delivered to the position of the aortic valve, and then the delivery sheath 203 is removed by operating the handle to release the compression of the delivery sheath 203 on the artificial valve, so that the artificial valve is released. After complete release, the delivery sheath 203 is pushed back to its original position, and then the delivery system 200 is operated to withdraw from the body. The delivery head 201 is generally a conical head, which can reduce the resistance of the structure in the human body lumen during delivery, facilitating delivery. It is made of soft plastic to prevent puncture of human tissue.

[0076] Thus, when the artificial valve of the present invention is applied to aortic regurgitation, Figure 4 As shown, the other ends 121 of the first support arms 120 are all oriented toward the inflow end 111. Multiple first support arms 120 are respectively inserted into the three main valve sinuses, allowing the native valve leaflets 11 to enter between the first support arms 120 and the stent body 110, thereby positioning and anchoring the stent body 110. At this point, the second support arms 130 further expand the tissue, allowing a certain amount of space for blood to pass through the coronary artery opening 12, thereby preventing blood flow obstruction caused by the close proximity of the aortic wall and the artificial valve.

[0077] As for the second support arm 130, it should be understood that when the second support arm 120 pushes open the aortic wall to provide space for subsequent operations, subsequent operations are less susceptible to tissue interference, allowing the delivery system 200 to move forward, backward or rotate smoothly, and also allowing the first support arm 120 to be smoothly deployed, effectively reducing the difficulty of surgical operations.

[0078] In summary, the artificial valve and valve stent provided by the present invention have at least the following advantages:

[0079] (1) Through the synergistic effect of the first support arm 120 and the second support arm 130, reliable anchoring is achieved for patients with pure aortic regurgitation; of course, after the stent body 110 is deployed in the body, there is an extrusion relationship between it and the native tissue, which also provides radial support force to a certain extent, thereby increasing the stability of the anchoring.

[0080] (2) The first support arm 120 and the second support arm 130 have simple structures, and it is not easy to increase the size of the valve stent 100. Moreover, the first support arm 120 is inserted into the bottom of the aortic sinus to position the artificial valve, which is accurate and reliable.

[0081] (3) Before the first support arm 120 is released, the tissue is first expanded by the second support arm 130. This not only facilitates subsequent operations and reduces the difficulty of subsequent operations, but also prevents the valve stent 100 from blocking the coronary artery opening 12 after the aortic wall is expanded, which is beneficial to improving the fluid mechanics of the coronary artery.

[0082] In general, the present invention can achieve valve replacement for patients with pure aortic regurgitation. During replacement, several first support arms 120 are used to position and anchor the valve, and at least one second support arm 130 is used to support the aortic wall to avoid affecting the coronary artery opening 12. This structure is simple, positioning is accurate, the surgical operation is not complicated, and the reliability is high.

[0083] Finally, it should be noted that, in addition to the structures of the first support arm 120 and the second support arm 130 listed in the following embodiments, technical personnel in the relevant field can find other alternative ways to achieve the functions recorded in the present invention / achieve the above-mentioned effects based on the description of the present invention, and not just the solutions disclosed in the embodiments of the present invention.

[0084] It should be noted that those skilled in the art can make several improvements and additions without departing from the disclosure of this application, and these improvements and additions should also be considered as the scope of protection of this application. Any equivalent changes, modifications and evolutions made by those skilled in the art using the technical content disclosed above without departing from the spirit and scope of this application are equivalent embodiments of this application; at the same time, any equivalent changes, modifications and evolutions made to the above embodiments based on the essential technology of this application are still within the scope of the technical solution of this application.

Claims

1. A valve stent, characterized in that: include: Bracket body; a plurality of first support arms, wherein the plurality of first support arms are arranged along the circumference of the bracket body, one end of each first support arm is connected to the outflow end of the bracket body, and the other end of each first support arm is disposed outside the bracket body and extends toward the inflow end of the bracket body; as well as, at least one second support arm, one end of the second support arm being connected to the outflow end of the bracket body, and the other end of the second support arm being disposed outside the bracket body; The stent body is used to be placed at the aortic valve, and the stent body and the first support arm are used to accommodate the native valve leaflet, and the other end of each first support arm is used to extend into the corresponding aortic sinus to provide anchoring. At least one first support arm is used to be set in each aortic sinus, and the second support arm is used to support the aortic wall.

2. The valve stent according to claim 1, wherein The number of the first support arms is three, and one first support arm is provided in each aortic sinus.

3. The valve stent according to claim 1, wherein: The second support arm can be released from the conveying system before the first support arm.

4. The valve stent according to claim 1, wherein: The second support arm and the first support arm at least partially overlap in the circumferential direction of the bracket body, or the second support arm and the first support arm do not overlap in the circumferential direction of the bracket body.

5. The valve stent according to claim 4, characterized in that: The first support arm and the second support arm are staggered in upper and lower layers along the axial direction of the bracket body, or staggered in inner and outer layers along the radial direction of the bracket body.

6. The valve stent according to claim 1, wherein: There are multiple second support arms, and the multiple second support arms are arranged along the circumference of the bracket body.

7. The valve stent according to claim 6, characterized in that: The number of the second supporting arms is three.

8. The valve stent according to claim 1, wherein: The radial dimension of the second support arm after expansion is greater than the radial dimension of the first support arm after expansion.

9. The valve stent according to claim 1, wherein: The length of the first support arm is smaller than the length of the bracket body, and the length of the second support arm is smaller than the length of the first support arm.

10. The valve stent according to claim 1, wherein: The other end of the first support arm has a rounded structure, and / or the other end of the second support arm has a rounded structure.

11. The valve stent according to claim 1, wherein: The first support arm and the bracket body are integrally formed, or the first support arm and the bracket body are separately formed and connected.

12. The valve stent according to claim 1, wherein: The second support arm is integrally formed with the bracket body, or the second support arm is separately formed and connected with the bracket body.

13. An artificial valve, characterized in that: A valve stent according to any one of claims 1 to 12 is provided.

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