Valve stent and artificial valve

Abstract

The invention provides a valve stent and an artificial valve. The valve stent comprises a stent main body, the first supporting arms are arranged in the circumferential direction of the support body, one end of each first supporting arm is connected with the outflow end of the support body, and the other end of each first supporting arm is arranged outside the support body and extends towards the inflow end of the support body; one end of the second supporting arm is connected with the outflow end of the support body, and the other end of the second supporting arm is arranged outside the support body. The stent body can be placed at the aortic valve, native valve leaflets are contained between the stent body and the first supporting arms, the other ends of the first supporting arms extend into the corresponding aortic sinus to provide anchoring, at least one first supporting arm can be arranged in each aortic sinus, and the second supporting arms can open the aortic wall. According to the invention, replacement can be carried out on aortic valve regurgitation, stable and reliable anchoring can be realized through a unique anchoring structure, and a coronary artery opening is not easy to block.

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). The pumping action of the left and right sides of the heart generally occurs synchronously throughout the cardiac cycle. The valves that separate the atria from the ventricles are called the atrioventricular valves, which act as one-way valves to ensure the normal flow of blood in 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 and from there to the lungs; blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria. At the beginning of ventricular filling (diastole), the aortic valve and the pulmonary valve close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the atrioventricular valve opens to allow unimpeded flow from the atria into the corresponding ventricle. The tricuspid and mitral valves normally close shortly after the onset of ventricular systole (i.e., emptying of the ventricles), 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 backwards (regurgitate) through the valves. Heart valve insufficiency can have serious consequences for patients, often leading to heart failure, decreased blood flow, decreased 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 not treated, can lead to permanent disability or death.

[0003] In recent years, transcatheter aortic valve replacement (TAVR) has developed rapidly, and its status in the treatment of aortic stenosis (AS) has gradually increased. It is also used to treat specific AR patients, and domestic and foreign guidelines have also made relevant recommendations. Unlike Western countries, in clinical practice in my country, AR patients are not less than AS patients. According to the data of the China Valvular Heart Disease Registry Study (China-DVD Study): From September to December 2016, researchers conducted the first national survey on elderly patients with valvular heart disease, and selected nearly 9,000 inpatients aged 60 years and above from 69 hospitals in 28 provinces, municipalities and autonomous regions across the country. Among them, patients with simple aortic regurgitation (PAR) accounted for 10.2%, and patients with AS accounted for 5.1%. Among patients with severe valvular diseases, the proportion of AR and AS patients is similar. Although TAVR has developed rapidly, it is still difficult to use it in patients with simple aortic regurgitation (PAR) with surgical contraindications or high risk, as well as patients with PAR with suitable anatomical structure, because most PAR patients have large valve rings and severe aortic dilation, which cannot be closed, easily causing regurgitation, and also prone to device-related thrombosis. These patients have larger ventricles, increased stroke volume, greater hemodynamic impact, and no or minimal calcification of the valve leaflets, making anchoring more difficult. Existing technologies do not consider the impact on coronary hemodynamics when treating pure aortic regurgitation, which can easily block the coronary artery opening.

[0004] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or suggestion in any form that the information constitutes prior art already known to those skilled in the art. Summary of the invention

[0005] In view of the defects of the prior art, the present invention proposes a valve stent and an artificial valve for replacing a simple aortic regurgitation valve, which can achieve stable and reliable anchoring through a unique anchoring structure without blocking the coronary artery opening.

[0006] To achieve the above object, the present invention provides a valve stent, comprising:

[0007] The support body;

[0008] 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 of the first support arms is connected to the outflow end of the bracket body, and the other end of each of the first support arms is arranged outside the bracket body and extends toward the inflow end of the bracket body; and,

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

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

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

[0013] Preferably, the second support arm at least partially overlaps with the first support arm in the circumferential direction of the bracket body, or the second support arm does not overlap with the first support arm 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 support body, or staggered in inner and outer layers along the radial direction of the support 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 supporting arms is three.

[0017] Preferably, the radial dimension of the second support arm after being unfolded is larger than the radial dimension of the first support arm after being unfolded.

[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, wherein the plurality of first support arms are arranged along the circumference of the stent body, one end of each of the first support arms is connected to the outflow end of the stent body, and the other end of each of the first support arms is arranged outside the stent body and extends toward the inflow end of the stent body; and at least one second support arm, wherein 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 outside 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 arms is used to accommodate the native leaflets, and the other end of each of the first support arms is used to extend into the corresponding aortic sinus to provide anchoring, and at least one of the first support arms is used to be arranged in each aortic sinus, and the second support arm is used to support the aortic wall.

[0024] With such configuration, when replacing a simple aortic regurgitation valve, the present invention can provide a strong anchoring force through the first support arm and the second support arm, so as to achieve valve replacement for pure aortic regurgitation patients who are not easy to anchor, and achieve stable and reliable anchoring. At the same time, the present invention can also prevent the valve stent from interfering with and blocking the coronary artery opening through the second support arm, thereby avoiding the impact on the coronary artery hemodynamics, and during the delivery process, after the aortic wall is opened, it can also provide space for subsequent operations, reduce the difficulty of subsequent operations, and thus ensure the accuracy and reliability of positioning.

[0025] Since the artificial valve provided in the present application and the valve stent provided in the present application belong to the same inventive concept, the artificial valve provided in the present application has all the advantages of the valve stent provided in the present application, so the beneficial effects of the artificial valve provided in the present 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 It is a 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 It is a schematic diagram of the top structure of the valve stent when observing it 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 of placing a valve stent at a native aortic valve in vivo according to one embodiment of the present invention.

[0031] Figure 5 It is a diagram of a process of 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] In order to make the purpose, 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 accompanying drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0035] In this article, "top" and "bottom" are viewed from the direction of the heart blood flow through the artificial valve. Although "top" and "bottom" are not restrictive, "bottom" usually refers to the end close to the blood flow into the artificial valve, and "top" usually refers to the end close to the blood flow out of the artificial valve. As used in this specification, the singular forms "one", "an" and "the" include plural objects unless the content clearly indicates otherwise. As used in this specification, the term "or" is usually used in the sense of including "and / or" unless the content clearly indicates otherwise. In addition, the term "radial" refers to the direction perpendicular to the axis of the artificial valve or valve stent; "axial" refers to the direction parallel to the axis of the artificial valve or valve stent; "circumferential" refers to the direction around the axis of the artificial valve or valve stent; "inner side" refers to the side closer to the axis of the artificial valve or valve stent; "length" refers to the dimension along the axial direction of the valve stent. "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 difficulty in anchoring, unstable anchoring and influence on coronary hemodynamics.

[0037] The artificial valve provided by the present invention may be delivered via the apex, via the femoral artery, or via other routes, and the present invention is not limited thereto.

[0038] The following description is given with reference to the accompanying drawings.

[0039] Please refer to Figures 1 to 4 As shown, in an embodiment of the present invention, a valve stent 100 is provided, which includes 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 an inflow end 111 and an outflow end 112 relative to each other. According to the normal flow direction of blood, the inflow end 111 refers to the position where blood flows into the valve stent 100, and is also the end of the valve stent 100 close to the left ventricle. The position corresponding to the inflow end 111 is the inflow channel of the valve stent 100; and the outflow end 112 refers to the position where blood flows out of the valve stent 100, and is also the end of the valve stent 100 away from the left ventricle. The position corresponding to the outflow end 112 is the outflow channel of the valve stent 100. The outflow channel is located downstream of the inflow channel. If the blood flows from the valve stent 100, the outflow channel will be the same as the outflow channel. Figure 1 From the orientation shown, the outflow end 112 is the top end of the stent body 110 , the inflow end 111 is the bottom end of the stent body 110 , and the direction along the inflow end 111 - 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, mostly set to be cylindrical. The stent body 110 usually adopts a diamond grid, and is responsible for carrying artificial valve leaflets, skirts and other structures. The artificial valve leaflets and skirts are all existing technologies. The material for preparing the stent body 110 is not particularly limited. For example, it is made of nickel-titanium alloy or other biocompatible materials with shape memory properties. It can also 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 disposed outside 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, and it is necessary to ensure that the first support arm 120 can extend into the aortic sinus and contact the bottom of the aortic sinus, and ensure 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 to form 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, the native valve leaflet 11 is accommodated between the stent body 110 and the first support arm 120, and 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 in 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, and preferably only one first support arm 120 is provided. Specifically in this embodiment, the number of the first support arms 120 is consistent with the number of the aortic sinuses, that is, three first support arms 120 are used, and only one first support arm 120 is provided in each aortic sinus, so that the structure is simple and the operation during surgery is more convenient.

[0046] The number of the second support arms 130 is one or more, and the 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 are easy to 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 propping up 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, and 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 arranged outside the stent body 110. Preferably, the second support arm 130 can be released before the first support arm 120 is separated from the delivery sheath 203. 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, so as to facilitate the first release of the second support arm 130.

[0048] Reference Figure 4 As shown, when replacing a simple aortic regurgitation valve, the second support arm 130 can 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 replacing the aortic valve, 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 function to a certain extent, further increase the stability and reliability of anchoring, and after opening the aortic wall, it can also provide space for subsequent operations, reduce the difficulty of subsequent operations, and ensure 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 by 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, reducing damage to tissues, skirts and other structures in the body.

[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 closely attached to the outer wall of the stent body 110 without increasing the delivery size too much. 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 may 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 specifically 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 may adopt a V-shaped or U-shaped or C-shaped 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 the present application is applicable to this; in addition, in addition to the linear structure shown in the figure, the first support arm 120 has other structural forms, such as a sheet structure or a mesh structure, and the present application is also applicable to this, 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, the first support arm 120 and the support body 110 are cut and formed integrally. When 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 with the support body 110, for example, the first support arm 120 is connected to the outflow end 112 of the support body 110 by welding, riveting, bonding or other connection methods.

[0054] The first support arm 120 and the second support arm 130 do not interfere with each other, and both can be released independently. The positions of the first support arm 120 and the second support arm 130 in the circumferential direction of the support 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 support body 110, the second support arm 130 can be moved to the position of the first support arm 120, and vice versa, when the second support arm 130 is kept stationary, if the first support arm 120 is moved along the axial direction of the support body 110, the first support arm 120 can be moved to the position of the second support arm 130.

[0055] Although the first support arm 120 and the second support arm 130 shown in the drawings 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, when the first support arm 120 is kept stationary, if the second support arm 130 is moved along the axial direction of the stent body 110, the second support arm 130 cannot move to the position of the first support arm 120, and vice versa, when the second support arm 130 is kept stationary, if the first support arm 120 is moved along the axial direction of the stent body 110, the first support arm 120 also cannot move to the position of the second support arm 130. In view of the fact that the aortic sinus and the coronary artery opening 12 are usually in a corresponding relationship, 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 the axial direction of the support body 110, or staggered in the radial direction of the support body 110. In addition, the first support arm 120 and the second support arm 130 can also be cross-distributed in the circumferential direction of the support body 110, as long as the two can be folded and unfolded without interfering with each other.

[0057] Preferably, the radial dimension of the second support arm 130 after being expanded is greater than the radial dimension of the first support arm 120 after being expanded, 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 being expanded is greater than the radial dimension of the first support arm 120 after being expanded, 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 overall strength of the second support arm 130 is greater than that of the first support arm 120, and the aortic wall can be smoothly propped open. The second support arm 130 itself is elastic, and its other end 131 can form point contact, line contact, or surface contact with the aortic wall, preferably line contact or surface contact. Preferably, the other end 131 of the second support arm 130 is a smooth structure, and there are no protruding edges and corners, so as to reduce damage to the aortic wall.

[0060] The second support arm 130 can be folded and unfolded, and can switch between the folded state and the unfolded state. Similar to the first support arm 120, during transportation, the second support arm 130 is constrained by the transportation system 200 and is in a folded state. In the folded state, the second support arm 130 can be straightened for transportation, and the size is small. After leaving the transportation system 200, the second support arm 130 automatically pops open and pushes open the aortic wall, which not only expands the operating space, but also leaves blood flow space for the coronary artery opening 12.

[0061] The second support arm 130 may 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. The present application does not limit the shape of the second support arm 130. In addition to the exemplified V-shaped, U-shaped, or C-shaped structures, other structural forms may also be used, as long as the second support arm 120 can prop up the blood vessel wall where it is located after being unfolded.

[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, and when the second support arm 130 is cut and formed integrally, the net rod can be directly turned outward to form the second support arm 130. The second support arm 130 can also be separately formed and connected with the support body 110, 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 transport connections 140 are provided on the stent body 110, and the plurality of transport connections 140 are distributed along the circumference of the stent body 110. Preferably, the plurality of transport connections 140 are evenly distributed along the circumference of the stent body 110. The transport connection 140 is disposed at the outflow end 112 of the stent body 110. Each transport connection 140 is used to be detachably connected to the transport system 200 to ensure that the relative position of the artificial valve and the transport system 200 remains unchanged when the artificial valve is loaded into the transport system 200, released from the transport system 200, and transported in the body. There are usually no less than three transport connections 140, and a more suitable number is three. It should be noted that there are a variety of ways to structure the transport connection 140, and at least one of them can be selected to be implemented, which is exemplarily described 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 Figure 5 ) to prevent the valve stent 100 from falling off during transportation. The hanging ear can be selected as a T-shaped structure, but it 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, which includes the valve stent 100 described in any embodiment, and also includes an artificial valve leaflet (not shown). The artificial valve leaflet is arranged in the stent body 110. The artificial valve leaflet is made of animal pericardium or other biocompatible polymer materials. The artificial valve leaflet replaces the native valve leaflet in the working state to realize 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 a single channel for blood to flow from the inflow end 111 of the stent body 110 to the outflow end 112 of the stent body 110 can be better ensured. 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 describes 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) in:

[0069] First, Figure 5 In step (a), the delivery system 200 enters the aortic root through the femoral artery, and the position of the delivery system 200 can be adjusted to have 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 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 determining that the first support arm 120 is fully released, continue to push the delivery system 200 forward, and release the bottom end of the stent body 110 after the bottom end of the stent body 110 passes over the aortic valve ring and the first support arm 120 enters the aortic sinus bottom, so that the stent body 110 is fully expanded and unfolded, that is, anchoring is completed, and the artificial valve starts to work.

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

[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. When in use, the delivery system 200 is first delivered to the position of the aortic valve, and then the delivery sheath 203 is removed by operation through 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 exit 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, facilitate delivery, and 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 facing the inflow end 111, and the multiple first support arms 120 are respectively inserted into the three main valve sinuses, so that the native valve leaflets 11 enter between the first support arms 120 and the stent body 110, and the stent body 110 is positioned and anchored. At this time, the second support arms 130 further open the tissue, so that there is a certain space for blood to pass through the coronary artery opening 12, to prevent the aortic wall and the artificial valve from being too close to cause blood flow obstruction.

[0077] 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 not easily interfered by tissues, so that the delivery system 200 can move forward, backward or rotate smoothly, and the first support arm 120 can 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 a squeezing relationship with 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 a simple structure, 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 open 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 in the specification of the present invention, and not just the solutions disclosed in the embodiments of the present invention.

[0084] It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the content disclosed in this application, and these improvements and supplements should also be regarded as the protection scope of this application. Any technician familiar with this profession can make some changes, modifications and evolutions of the technical content disclosed above without departing from the spirit and scope of this application, which are equivalent embodiments of this application; at the same time, any changes, modifications and evolutions of any equivalent changes 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: The support 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 of the first support arms is connected to the outflow end of the bracket body, and the other end of each of the first support arms is arranged 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 is connected to the outflow end of the support body, and the other end of the second support arm is arranged outside the support 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, 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.

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

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

4. The valve stent according to claim 1, characterized in that: The second support arm at least partially overlaps with the first support arm in the circumferential direction of the bracket body, or the second support arm does not overlap with the first support arm 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 support body, or staggered in inner and outer layers along the radial direction of the support body.

6. The valve stent according to claim 1, characterized in that: 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, characterized in that: The radial dimension of the second support arm after being expanded is greater than the radial dimension of the first support arm after being expanded.

9. The valve stent according to claim 1, characterized in that: 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, characterized in that: The other end of the first supporting arm is a rounded structure, and / or the other end of the second supporting arm is a rounded structure.

11. The valve stent according to claim 1, characterized in that: 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, characterized in that: 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 as described in any one of claims 1-12 is provided.

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