Valve prosthesis

Abstract

The invention relates to the technical field of medical instruments, in particular to a valve prosthesis which comprises an inner support and an outer support arranged on the peripheral side of the inner support, the bottom of the inner support is connected with the bottom of the outer support, and first barbs are arranged on the outer support. The first barbs extend from the outer support in the direction away from the bottom of the outer support and inclining towards the outer side of the outer support. The first barbs on the outer stent are inserted into the tissue, so that the outer stent and the tissue are more firmly anchored under the condition that the hardness of the outer stent is not increased, the valve prosthesis can be effectively prevented from inclining or turning on one side, and the stable fixity of the valve prosthesis is remarkably improved.

Description

Technical Field

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

[0002] The mitral valve is one of the four major heart valves, located between the left atrium and the left ventricle. Normally, the mitral valve closes and opens following the contraction and dilation of the heart, maintaining the one-way flow of blood from the left atrium to the left ventricle. When mitral regurgitation occurs, during heart contraction, a part of the blood will flow back into the left atrium, resulting in mitral regurgitation. Mitral regurgitation causes an increase in the pressure of the left atrium, leading to an increase in the pressure of the pulmonary veins. At the same time, the volume load during the diastolic phase of the left ventricle increases, and the left ventricle expands. In the late stage, pulmonary hypertension and congestive heart failure may even occur.

[0003] With the development of social economy and the aging of the population, the incidence of valvular heart disease has increased significantly. Research shows that the incidence of valvular heart disease in the elderly population over 75 years old is as high as 13.3%. Currently, traditional surgical treatment is still the preferred treatment method for patients with severe valvular lesions. However, for patients who are elderly, have multiple organ diseases, have a history of thoracotomy, and have poor cardiac function, traditional surgical treatment has high risks and mortality rates, and some patients even have no chance of surgery. Transcatheter mitral valve replacement / repair has the advantages of no need for thoracotomy, minimal trauma, and rapid patient recovery, and has received extensive attention from experts and scholars.

[0004] Transcatheter heart valve replacement has been rapidly developed and applied clinically. Through minimally invasive small incisions, an artificial heart valve is implanted at the native heart valve site to replace the diseased valve and restore the normal heart valve function. Minimally invasive intervention has minimal trauma and rapid recovery, and is increasingly recognized by doctors and patients.

[0005] The existing ball-cage type mitral valve prosthesis in the prior art has great advantages in terms of short operation time and short doctor learning curve. After being implanted into the body, it relies on the self-expansion of the ball-cage to expand the atrium to a certain extent, so that the ball-cage structure is closely attached to the atrial wall to achieve the fixation of the valve prosthesis in the heart. However, firstly, the expandability of the atrial wall tissue itself is relatively large, and there are folded grooves between the pectinate muscles of the auricle, which further enhances the expandability of the atrium; secondly, as time goes by, the left atrial tissue remodels, and the contact force between the atrial wall and the valve prosthesis will weaken; in addition, due to the limitation of imaging, some tissues of the left atrium cannot be fully presented under imaging, and the actual internal space of the left atrium cannot be well measured. Due to these three factors, during the beating of the heart, under the relatively large force of the left ventricle, the valve prosthesis will deviate relatively greatly from its initial implanted position, and even the entire valve prosthesis will tilt or even flip in the left atrium, resulting in the failure of the valve prosthesis. Summary of the Invention

[0006] In view of the above-mentioned deficiencies of the prior art, the technical problem to be solved by the present invention is to provide a valve prosthesis that can improve the stable fixation.

[0007] To solve the above technical problems, the present invention adopts the following technical solutions:

[0008] The present invention provides a valve prosthesis, including an inner stent and an outer stent disposed on the outer peripheral side of the inner stent. The bottom of the inner stent is connected to the bottom of the outer stent. The outer stent is provided with first barbs, and the first barbs extend from the outer stent in a direction away from the bottom of the outer stent and inclined outwardly of the outer stent.

[0009] Preferably, the first barb has a head end away from the outer stent, and the head end is a smooth end.

[0010] Preferably, the first barb includes two barbs forming an angle. One ends of the two barbs are circumferentially spaced on the outer stent, and the other ends of the two barbs are smoothly connected by a fillet to form the head end; or the other ends of the two barbs are connected by a shoulder and are both smoothly connected to the shoulder by a fillet to form the head end, and a sharp cone is provided on the side of the shoulder away from the outer stent.

[0011] Preferably, the first barb includes two parallel barbs. One ends of the two barbs are circumferentially spaced on the outer stent, and the other ends of the two barbs are smoothly connected by an arc portion to form the head end.

[0012] Preferably, the first barb includes a barb. One end of the barb is located on the outer stent, and the other end of the barb is provided with a blunt head to form the head end.

[0013] Preferably, the first barb includes two barbs forming an angle. One ends of the two barbs intersect on the outer stent, and the other ends of the two barbs are both provided with blunt heads to form the head end.

[0014] Preferably, the angle at which the first barb inclines from the outer stent to the outside of the outer stent is 30°-60°.

[0015] Preferably, a connecting member is provided at the top of the outer stent. The top surface of the connecting member faces the outside of the outer stent, and second barbs are provided on the top surface of the connecting member.

[0016] Preferably, the second barb is in a sharp cone shape or a cone shape or a cylindrical shape.

[0017] Preferably, the valve prosthesis further includes an inner skirt provided on the inner peripheral surface and / or the outer peripheral surface of the inner stent, an outer skirt provided on the inner peripheral surface and / or the outer peripheral surface of the outer stent, and valve leaflets provided on the inner stent. The valve leaflets, the inner skirt and the outer skirt form an openable or closable one-way channel.

[0018] Compared with the prior art, the present invention has significant progress:

[0019] The valve prosthesis of the present invention inserts into the tissue through the first barbs on the outer stent, achieving a more firm anchoring of the outer stent to the tissue without increasing the hardness of the outer stent, effectively preventing the valve prosthesis from tilting or toppling, and thus significantly improving the stable fixation of the valve prosthesis. Description of the Drawings

[0020] Figure 1 is a schematic structural diagram of the valve prosthesis according to Embodiment 1 of the present invention.

[0021] Figure 2 is a schematic structural diagram of the inner and outer stents in the valve prosthesis according to Embodiment 1 of the present invention.

[0022] Figure 3 is Figure 2 an enlarged schematic diagram of part A in

[0023] Figure 4 is a schematic structural diagram of the inner and outer skirts in the valve prosthesis according to Embodiment 1 of the present invention.

[0024] Figure 5 is a schematic diagram of the closed and open states of the valve leaflets in the valve prosthesis according to Embodiment 1 of the present invention.

[0025] Figure 6 is a schematic structural diagram of the connecting member in the valve prosthesis according to Embodiment 1 of the present invention.

[0026] Figure 7 is a schematic diagram of the implanted state of the valve prosthesis according to Embodiment 1 of the present invention.

[0027] Figure 8 is a schematic structural diagram of the first barb in the valve prosthesis according to Embodiment 2 of the present invention.

[0028] Figure 9 is a schematic structural diagram of the first barb in the valve prosthesis according to Embodiment 3 of the present invention.

[0029] Figure 10 is a schematic structural diagram of the first barb in the valve prosthesis according to Embodiment 4 of the present invention.

[0030] Figure 11 is a schematic structural diagram of the first barb in the valve prosthesis according to Embodiment 5 of the present invention.

[0031] Figure 12 is a schematic structural diagram of the connecting member in the valve prosthesis according to Embodiment 6 of the present invention.

[0032] Among them, the description of the reference numerals is as follows:

[0033] 100 Valve prosthesis

[0034] 1 Inner stent

[0035] 2 Outer stent

[0036] 21 Stent rod

[0037] 3 Inner skirt

[0038] 4 Outer skirt

[0039] 5 Leaflet

[0040] 6 Straight rod

[0041] 7 Connector

[0042] 71 Hinge hole

[0043] 72 Threaded hole

[0044] 8 First barb

[0045] 8a Head end

[0046] 81 Barb rod

[0047] 82 Shoulder

[0048] 83 Taper

[0049] 84 Arc part

[0050] 85 Blunt head

[0051] 9 Second barb

[0052] 200 Left atrium

[0053] 201 Roof

[0054] 300 Left ventricle Detailed implementation manners

[0055] The following further describes in detail the specific implementation manners of the present invention with reference to the accompanying drawings. These implementation manners are only used to illustrate the present invention and are not intended to limit the present invention.

[0056] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0057] In the description of the present invention, it should be noted that unless otherwise clearly defined and limited, the terms "installation", "connection", and "coupling" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0058] In addition, in the description of the present invention, unless otherwise specified, the meaning of "a plurality" is two or more.

[0059] Embodiment 1

[0060] As Figures 1 to 7 shown, it is the first embodiment of the valve prosthesis provided by the present invention. The valve prosthesis 100 of this Embodiment 1 can be adapted to the mitral valve system for transcatheter intervention replacement, and is placed between the left atrium 200 and the left ventricle 300 to replace the native mitral valve. It should be noted that the valve prosthesis 100 of this Embodiment 1 is not limited to replacing the mitral valve, and can also be used to replace native valve structures such as the tricuspid valve, aortic valve, and pulmonary valve. The following takes the replacement of the mitral valve by the valve prosthesis 100 as an example for illustration.

[0061] Refer to Figures 1 to 6 , the valve prosthesis 100 of this Embodiment 1 includes an inner stent 1 and an outer stent 2.

[0062] Among them, the outer stent 2 is arranged on the outer peripheral side of the inner stent 1, and the bottom of the inner stent 1 is connected to the bottom of the outer stent 2. In this Embodiment 1, refer to Figure 1 and Figure 2 , the inner stent 1 is cylindrical, the outer stent 2 is spherical, the inner stent 1 is placed inside the outer stent 2, and the bottom of the inner stent 1 is connected to the bottom of the outer stent 2 through a plurality of straight rods 6 that are evenly arranged along the circumference of the inner stent 1 and extend outward from the inner stent 1, so that the inner stent 1 and the outer stent 2 form an integral spherical cage body.

[0063] Combined with Figure 4 and Figure 5, the valve prosthesis 100 of the first embodiment further includes an inner skirt 3, an outer skirt 4 and valve leaflets 5. The inner stent 1 provides an attachment position for the valve leaflets 5 and the inner skirt 3. The valve leaflets 5 are disposed on the inner stent 1, and the inner skirt 3 is disposed on the inner peripheral surface and / or the outer peripheral surface of the inner stent 1. The inner stent 1 is used for the installation and fixation of the valve leaflets 5 through the inner skirt 3. The inner stent 1 provides support for the inner skirt 3 and the valve leaflets 5. The inner skirt 3 provides circumferential sealing for the inner stent 1, and the valve leaflets 5 are used to replace the native valve. The outer stent 2 is used to fit with the atrial wall of the left atrium 200, and the straight rod 6 at the bottom of the outer stent 2 contacts the valve annulus. The outer skirt 4 is disposed on the inner peripheral surface and / or the outer peripheral surface of the outer stent 2. The outer skirt 4 provides circumferential sealing for the outer stent 2 and makes the valve prosthesis 100 contact tightly with the atrial wall of the left atrium 200, which can prevent blood from flowing through the gap between the valve prosthesis 100 and the atrial wall of the left atrium 200. The valve leaflets 5, the inner skirt 3 and the outer skirt 4 form a one-way channel that can be opened or closed, and the opening or closing of the one-way channel is realized through the valve leaflets 5. Preferably, there are three valve leaflets 5. The three valve leaflets 5 are sutured to the inner side of the inner stent 1 by sutures and are evenly arranged in a circle along the circumference of the inner stent 1, and can be in a flat closed state as shown in Figure 5 5a in Figure 5 and a folded open state as shown in 5b in Figure 6 . Thus, the stability of the opening and closing of the valve leaflets 5 of the valve prosthesis 100 can be ensured, and the one-way conductivity of the one-way channel can be maintained. Of course, the number of the valve leaflets 5 is not limited and can be set according to actual needs. Referring to Figure 6 , a connecting member 7 is provided at the top of the outer stent 2. A plurality of hinge holes 71 are evenly spaced along the circumferential direction on the outer peripheral surface of the connecting member 7. The top of the outer stent 2 has a plurality of stent rods 21 evenly spaced along the circumferential direction. The plurality of stent rods 21 are hinged to the plurality of hinge holes 71 one by one to realize the connection between the outer stent 2 and the connecting member 7. The top surface of the connecting member 7 faces the outside of the outer stent 2. A threaded hole 72 is opened on the top surface of the connecting member 7 for connecting with the delivery system to implant the valve prosthesis 100 between the left atrium 200 and the left ventricle 300 through the delivery system.

[0064] See Figure 7, the implantation process of the valve prosthesis 100 is as follows: First, load the valve prosthesis 100 onto the delivery system. The head end of the delivery system mandrel is fixedly connected to the threaded hole 72 on the connector 7. The bottom end of the valve prosthesis 100 contacts the distal end of the inner tube. The delivery system enters the left ventricle 300 through the apical puncture point and then crosses the mitral valve, and sends the valve prosthesis 100 into the left atrium 200 until the valve prosthesis 100 contacts the roof 201 of the left atrium 200. Finally, the valve prosthesis 100 is detached from the delivery system to release the valve prosthesis 100. The implantation process of the valve prosthesis 100 is prior art and will not be elaborated herein. After implantation, the valve prosthesis 100 is located between the left atrium 200 and the left ventricle 300 and replaces the native mitral valve. When the left ventricle 300 relaxes, the blood flow direction is from the left atrium 200 to the left ventricle 300. At this time, the valve leaflets 5 of the valve prosthesis 100 open, and blood can flow into the left ventricle 300 through the opened valve leaflets 5; when the left ventricle 300 contracts, blood flows from the left ventricle 300 into the aorta, and the valve leaflets 5 of the valve prosthesis 100 are pressed to close to prevent blood from flowing back into the left atrium 200.

[0065] The above-mentioned valve prosthesis 100 relies on the outer stent 2 to closely adhere to the atrial wall and valve annulus of the left atrium 200, so as to increase the contact force between the left atrium 200 tissue and the valve prosthesis 100 as much as possible to achieve relative fixation of the position of the valve prosthesis 100 in the heart. In order to enable the valve prosthesis 100 to better adhere to the atrial wall and valve annulus of the left atrium 200, it is required that the inner stent 1 of the valve prosthesis 100 is harder and the outer stent 2 is relatively softer, so as to adapt the outer stent 2 of the valve prosthesis 100 to the structure of the left atrium 200. However, when the heart contracts and the blood impacts the valve leaflets 5, especially when the resultant force direction of the three valve leaflets 5 forms a certain angle with the symmetry center of the ball cage body, it will surely cause the valve prosthesis 100 to tend to tilt or flip in the direction of the torque caused by the force.

[0066] In the first embodiment, refer to Figures 1 to 3A first barb 8 is provided on the outer support 2 of the valve prosthesis 100. The first barb 8 extends from the outer support 2 in a direction away from the bottom of the outer support 2 and inclined toward the outside of the outer support 2. The first barb 8 is used to be inserted into the atrial wall of the left atrium 200, such as the groove between the pectinate muscles of the auricle, during the implantation of the valve prosthesis 100, thereby providing auxiliary effect on the stability of the outer support 2. In the first embodiment, during the implantation of the valve prosthesis 100, the bottom end of the valve prosthesis 100 loaded into the delivery system contacts the distal end of the inner tube, and the first barb 8 extending from the upper edge of the outer stent 2 away from the bottom of the outer stent 2 and inclining toward the outer side of the outer stent 2 extends toward the proximal end of the delivery system. During the release of the valve prosthesis 100, as the distal end is released, the first barb 8 close to the bottom of the outer stent 2 is released first, and then the first barb 8 away from the top of the outer stent 2 is released, thereby facilitating the release of the valve prosthesis 100. At the same time, after the release, the first barb 8 can open smoothly and penetrate into the wall of the left atrium 200. When the valve prosthesis 100 is used to replace other native valve structures, the first barb 8 can penetrate into the corresponding tissue in the same manner. Therefore, the valve prosthesis 100 of the first embodiment can anchor the outer stent 2 to the tissue more firmly without increasing the hardness of the outer stent 2 , effectively preventing the valve prosthesis 100 from tilting or tipping over, thereby significantly improving the stability and fixation of the valve prosthesis 100 .

[0067] In this embodiment 1, see Figure 3 The first barb 8 on the outer stent 2 has a head end 8a away from the outer stent 2. During the implantation of the valve prosthesis 100, the first barb 8 on the outer stent 2 is inserted into the wall of the left atrium 200 through the head end 8a. Preferably, the head end 8a is a smooth end, which is friendly to the wall of the left atrium 200 and can prevent piercing the wall of the left atrium 200.

[0068] Preferably, in the first embodiment, the first barb 8 includes two thorn rods 81 at an angle, one end of the two thorn rods 81 is located on the outer bracket 2 at intervals along the circumference of the outer bracket 2, and the other ends of the two thorn rods 81 are connected by a rounded corner and a smooth transition to form a head end 8a of the first barb 8, so that the head end 8a is a smooth end.

[0069] In the first embodiment, the first barb 8 is preferably inclined at an angle of 30°-60° from the outer stent 2 to the outer side of the outer stent 2, which can achieve better penetration into the wall of the left atrium 200 and facilitate installation of the valve prosthesis 100 in the sheath of the delivery system.

[0070] In the first embodiment, the position where the first barb 8 is provided on the outer stent 2 is not limited, and the first barb 8 can be arbitrarily provided on the outer stent 2. Preferably, the first barb 8 is provided at the top of the outer stent 2. Specifically, the connecting member 7 is provided at the central position of the top end side of the outer stent 2, and the first barb 8 is provided on the top of the outer stent 2 close to the connecting member 7.

[0071] In the first embodiment, the number of the first barbs 8 provided on the outer stent 2 is not limited. Preferably, at least one row of first barbs 8 is provided on the outer stent 2. Each row of first barbs 8 includes a plurality of first barbs 8 that are evenly spaced along the circumferential direction of the outer stent 2 to form a circle, and each row of first barbs 8 is spaced along the axial direction of the outer stent 2. Increasing the number of the first barbs 8 can make the outer stent 2 of the valve prosthesis 100 more firmly anchored to the left atrium 200.

[0072] Embodiment Two

[0073] As Figure 8 shown, it is the second embodiment of the valve prosthesis provided by the present invention. Embodiment Two is basically the same as Embodiment One, and the same parts will not be described again. The difference lies in the structure of the first barb 8. Specifically, in the valve prosthesis 100 of this Embodiment Two, the first barb 8 includes two bar shafts 81 forming an angle. One ends of the two bar shafts 81 are circumferentially spaced on the outer stent 2, and the other ends of the two bar shafts 81 are connected by a shoulder 82. Moreover, a fillet is smoothly connected between the other ends of the two bar shafts 81 and the shoulder 82 to form the head end 8a of the first barb 8, so that the head end 8a is substantially a smooth end. A sharp cone 83 is provided on the side of the shoulder 82 away from the outer stent 2, and the sharp cone 83 protrudes from the shoulder 82 by a small distance, and can pierce into the atrial wall tissue of the left atrium 200 at the smooth part of the atrial wall of the left atrium 200. The existence of the shoulder 82 can well limit the depth of the head end 8a of the first barb 8 piercing into the atrial wall of the left atrium 200 to prevent the atrial wall of the left atrium 200 from being punctured. Thus, in this Embodiment Two, the first barb 8 is a trapezoidal barb.

[0074] Embodiment Three

[0075] As Figure 9 shown, it is the third embodiment of the valve prosthesis provided by the present invention. Embodiment Three is basically the same as Embodiment One, and the same parts will not be described again. The difference lies in the structure of the first barb 8. Specifically, in the valve prosthesis 100 of this Embodiment Three, the first barb 8 includes two parallel bar shafts 81. One ends of the two bar shafts 81 are circumferentially spaced on the outer stent 2, and the other ends of the two bar shafts 81 are smoothly connected by an arc part 84 to form the head end 8a of the first barb 8, so that the head end 8a is a smooth end. Thus, in this Embodiment Three, the first barb 8 is a U-shaped barb.

[0076] Embodiment Four

[0077] As Figure 10 shown, it is the fourth embodiment of the valve prosthesis provided by the present invention. Embodiment Four is basically the same as Embodiment One, and the same parts will not be described again. The difference lies in the structure of the first barb 8. Specifically, in the valve prosthesis 100 of this Embodiment Four, the first barb 8 includes a barb rod 81. One end of the barb rod 81 is located on the outer stent 2, and the other end of the barb rod 81 is provided with a blunt head 85 to form the head end 8a of the first barb 8, so that the head end 8a is a smooth end. Thus, in this Embodiment Four, the first barb 8 is a single-barbed blunt barb.

[0078] Embodiment Five

[0079] As Figure 11 shown, it is the fifth embodiment of the valve prosthesis provided by the present invention. Embodiment Five is basically the same as Embodiment One, and the same parts will not be described again. The difference lies in the structure of the first barb 8. Specifically, in the valve prosthesis 100 of this Embodiment Five, the first barb 8 includes two barb rods 81 forming an angle. One ends of the two barb rods 81 intersect on the outer stent 2, and the other ends of the two barb rods 81 are both provided with blunt heads 85 to form the head end 8a of the first barb 8, so that the head end 8a is a smooth end. Thus, in this Embodiment Five, the first barb 8 is a V-shaped blunt barb.

[0080] It should be noted that for the valve prosthesis provided by the present invention, the structure of the first barb 8 provided on the outer stent 2 is not limited to the structure of the first barb 8 described in the above Embodiments One to Five, and other structural forms that are friendly to the atrial wall of the left atrium 200 and can avoid piercing the atrial wall of the left atrium 200 can also be adopted.

[0081] Embodiment Six

[0082] As Figure 12As shown, this is the sixth embodiment of the valve prosthesis provided by the present invention. Embodiment six is basically the same as Embodiment one, and the same parts will not be described again. The difference is that in this Embodiment six, a second barb 9 is provided on the top surface of the connecting member 7. During the process of implanting the valve prosthesis 100 through the apex of the heart, the connecting member 7 is first pushed out from the delivery system and is in close contact with the top of the atrial wall of the left atrium 200 (the roof 201). The thickness of the atrial wall of the left atrium 200 at the position where it contacts the connecting member 7 is relatively thick, reaching more than 2 mm. Therefore, by providing the second barb 9 on the top surface of the connecting member 7 and piercing the atrial wall of the left atrium 200 at the position where it contacts the connecting member 7, and combining with the outer stent 2 being in close contact with the atrial wall of the left atrium 200 circumferentially, it can further assist in fixing the outer stent 2 and prevent the valve prosthesis 100 from tilting or tipping over. Since the atrial wall of the left atrium 200 at the position where it contacts the connecting member 7 is relatively thick, the second barb 9 used to pierce this atrial wall can adopt a relatively sharp structure to increase the thickness of the pierced atrial wall and enhance the anchoring firmness. Preferably, the second barb 9 is in a sharp cone shape or a conical shape or a cylindrical shape.

[0083] In this Embodiment six, the setting position of the second barb 9 on the connecting member 7 is not limited and can be set at any position on the top surface of the connecting member 7 that avoids the threaded hole 72. The number of the second barbs 9 is not limited, and multiple barbs can be provided to increase the anchoring firmness.

[0084] It should be noted that in this Embodiment six, the structure of the first barb 8 provided on the outer stent 2 can be any one of the first barb 8 structures described in Embodiments one to five above, or other structural forms that are friendly to the atrial wall of the left atrium 200 and can avoid piercing the atrial wall of the left atrium 200.

[0085] The above are only the preferred embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art, without departing from the technical principle of the present invention, several improvements and substitutions can still be made, and these improvements and substitutions should also be regarded as the protection scope of the present invention.

Claims

1. A valve prosthesis, characterized in that, it includes an inner stent (1) and an outer stent (2) arranged on the outer peripheral side of the inner stent (1), the bottom of the inner stent (1) is connected to the bottom of the outer stent (2), and a first barb (8) is provided on the outer stent (2), and the first barb (8) extends from the outer stent (2) in a direction away from the bottom of the outer stent (2) and inclined toward the outside of the outer stent (2).

2. The valve prosthesis according to claim 1, characterized in that, the first barb (8) has a head end (8a) away from the outer stent (2), and the head end (8a) is a smooth end.

3. The valve prosthesis according to claim 2, characterized in that, the first barb (8) includes two barbed rods (81) forming an angle, one ends of the two barbed rods (81) are circumferentially spaced on the outer stent (2), and the other ends of the two barbed rods (81) are smoothly connected by a rounded corner to form the head end (8a); or, the other ends of the two barbed rods (81) are connected by a shoulder (82) and are both smoothly connected to the shoulder (82) by a rounded corner to form the head end (8a), and a sharp cone (83) is provided on the side of the shoulder (82) away from the outer stent (2).

4. The valve prosthesis according to claim 2, characterized in that, the first barb (8) includes two parallel barbed rods (81), one ends of the two barbed rods (81) are circumferentially spaced on the outer stent (2), and the other ends of the two barbed rods (81) are smoothly connected by an arc portion (84) to form the head end (8a).

5. The valve prosthesis according to claim 2, characterized in that, the first barb (8) includes a barbed rod (81), one end of the barbed rod (81) is located on the outer stent (2), and the other end of the barbed rod (81) is provided with a blunt head (85) to form the head end (8a).

6. The valve prosthesis according to claim 2, characterized in that, the first barb (8) includes two barbed rods (81) forming an angle, one ends of the two barbed rods (81) intersect on the outer stent (2), and the other ends of the two barbed rods (81) are both provided with blunt heads (85) to form the head end (8a).

7. The valve prosthesis according to claim 1, characterized in that, the angle at which the first barb (8) inclines from the outer stent (2) to the outside of the outer stent (2) is 30° - 60°.

8. The valve prosthesis according to claim 1, characterized in that, a connector (7) is provided at the top of the outer stent (2), the top surface of the connector (7) faces the outside of the outer stent (2), and a second barb (9) is provided on the top surface of the connector (7).

9. The valve prosthesis according to claim 8, characterized in that, the second barb (9) is in a sharp cone shape or a cone shape or a cylindrical shape.

10. The valve prosthesis according to any one of claims 1 - 9, characterized in that, The valve prosthesis further includes an inner skirt (3) disposed on the inner peripheral surface and / or the outer peripheral surface of the inner stent (1), an outer skirt (4) disposed on the inner peripheral surface and / or the outer peripheral surface of the outer stent (2), and leaflets (5) disposed on the inner stent (1), and the leaflets (5), the inner skirt (3) and the outer skirt (4) form a one-way channel that can be opened or closed.

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