Artificial valve and artificial valve system

Abstract

The present invention relates to an artificial valve and an artificial valve system, wherein the artificial valve is delivered by a delivery device. The artificial valve includes a main body stent, the main body stent has a connecting end, and the connecting end is releasably connected to the delivery device. The artificial valve further includes an anchor, and the anchor is connected to the connecting end. After the artificial valve of the present invention is released, the anchor can penetrate into the tissue to increase the stability after the artificial valve is implanted, and the artificial valve can be retracted into the delivery device again, repositioned and then released again, so as to improve the accuracy of the release position of the artificial valve, and further improve the safety of the artificial valve implantation.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and particularly to an artificial valve and an artificial valve system. Background Art

[0002] The main function of the heart is to provide power for the blood flow in the body. It includes the right atrium, the right ventricle, the left atrium, and the left ventricle. When the blood circulates, it flows into the right atrium from the superior vena cava and the inferior vena cava, then flows through the tricuspid valve into the right ventricle. Under the action of the contraction of the right ventricle, the blood flows into the lungs through the pulmonary artery valve. After the blood exchanges oxygen in the lungs, it flows into the left atrium, then flows through the mitral valve into the left ventricle. Under the action of the contraction of the left ventricle, the blood flows through the aortic valve into the aortic blood vessel and then into various parts of the body.

[0003] There are four valves in the human heart, namely the tricuspid valve, the pulmonary artery valve, the mitral valve, and the aortic valve. Among them, the tricuspid valve is located between the right atrium and the right ventricle; the mitral valve is located between the left atrium and the left ventricle. A normal valve formed naturally generally has a valve annulus and two or three valve leaflets. The root of the valve leaflet is fixed on the valve annulus; the free edge of the valve leaflet is connected with chordae tendineae, and the other end of the chordae tendineae is connected to the papillary muscle on the myocardial wall. The chordae tendineae can generate a traction force on the valve leaflet to open the valve leaflets from each other. After the traction force is withdrawn, the valve leaflets can close. The function of the valve is to restrict the direction of blood flow (similar to a one-way valve). When the valve leaflets open, it allows blood to flow from one end of the valve to the other end, and when the valve leaflets close, it prevents blood from flowing through the valve.

[0004] Currently, heart valve disease has become one of the common cardiovascular diseases, and its pathological changes are mainly dominated by insufficient valve leaflet closure. After percutaneous transcatheter implantation of an artificial valve, the artificial valve can replace the diseased valve and play the role of a one-way valve.

[0005] Currently, the artificial valve includes a valve frame and an artificial valve leaflet located inside the valve frame. After the valve frame is subjected to a radial compression force, it can be radially compressed and deformed. After the radial compression force is withdrawn, the valve frame can radially self-expand. The prior art mainly fixes it by means of interference fit between the self-expanded valve frame and the valve annulus tissue. This requires very high dimensional accuracy for the valve frame. The greater the extrusion force of the valve frame on the valve annulus, the more stable the implanted artificial valve is in the body. However, the greater the extrusion force of the valve frame on the valve annulus tissue, it will cause arrhythmia and heart failure. If the outer diameter of the valve frame is reduced to reduce the extrusion force of the valve frame on the valve annulus tissue, it will bring the problem of instability of the implanted artificial valve. Summary of the Invention

[0006] Based on this, it is necessary to provide an artificial valve to solve the problem of instability of the implanted artificial valve in the prior art.

[0007] In one embodiment, an artificial valve is provided. The artificial valve is delivered through a delivery device. The artificial valve includes a main body stent. The main body stent has a connection end, and the connection end is releasably connected to the delivery device. The artificial valve further includes an anchor, and the anchor is disposed on the connection end.

[0008] In one embodiment, the artificial valve further includes a plurality of connection structures. The plurality of connection structures are connected to the connection end, and the anchor is disposed on the connection structures. The anchor is disposed on the connection end through the connection structures.

[0009] In one embodiment, the number of the anchors is plural. The plurality of anchors are circumferentially distributed along the main body stent, and the specifications of the axial distances between the plurality of anchors and the connection end are at least two kinds.

[0010] In one embodiment, the connection end of the main body stent and the proximal end of the main body stent are the same end. The main body stent has a first side and a second side opposite to the first side. The specifications of the axial distances between the plurality of anchors and the proximal end of the main body stent are at least three kinds. Among the plurality of anchors, the anchor with the smallest axial distance from the proximal end of the main body stent is located on the first side, and the anchor with the largest axial distance from the proximal end of the main body stent among the plurality of anchors is located on the second side. Along the circumference of the main body stent from the first side to the second side, the axial distance between the anchor and the proximal end of the main body stent gradually increases.

[0011] In one embodiment, along the circumference of the main body stent from the first side to the second side, the plurality of ends of the plurality of anchors connected to the main body stent are arranged along an arc-shaped trajectory line.

[0012] In one embodiment, along the direction from the first side to the second side of the circumference of the main body stent, the slope of the arc-shaped trajectory line gradually increases.

[0013] In one embodiment, the plurality of ends of the plurality of anchors connected to the main body stent are located in a plane and are circumferentially distributed along the main body stent. The plane forms an angle θ with the end face where the connection end is located, and the angle θ is an acute angle.

[0014] In one embodiment, the main body stent includes an inflow end and an outflow end. The inflow end is for blood flow to flow in, and the outflow end is for blood flow to flow out. The outflow end and the connection end are the same end.

[0015] In one embodiment, the anchor is located proximal to the connection end.

[0016] In one embodiment, an artificial valve system is provided, including a delivery device and the above artificial valve. The delivery device is releasably connected to the connection end.

[0017] When the above artificial valve is implanted, the artificial valve is gradually released from one end of the main body stent towards the connection end. When the part of the main body stent except the connection end has been released, since the anchoring member is provided on the connection end, the anchoring member has not been released yet. That is to say, at this time, the anchoring member has not penetrated into the tissue. If it is found that the release position does not match the expectation at this time, the artificial valve can be retracted into the delivery device again, repositioned and then the artificial valve is released. When it is confirmed that the release position of the artificial valve is accurate, the connection structure is disengaged from the fixing seat. In this way, the accuracy of the artificial valve release can be improved. And after the artificial valve is released, the anchoring member can penetrate into the tissue, thereby increasing the stability after the artificial valve is implanted, and further preventing the implanted artificial valve from shifting, thus preventing paravalvular leakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 FIG. 6 is a perspective view of the artificial valve in the first embodiment of the present invention.

[0019] Figure 2 FIG. 7 is a schematic structural view of the main body stent, the connection structure and the anchoring member in the first embodiment of the present invention.

[0020] Figure 3 FIG. 8 is a schematic structural view of the connection structure and the anchoring member in the first embodiment of the present invention.

[0021] Figure 4 FIG. 9 is a perspective view of the artificial valve leaflet in the first embodiment of the present invention.

[0022] Figure 5 FIG. 10 is a schematic structural view of the delivery device in the first embodiment of the present invention.

[0023] Figure 6 FIG. 11 is a state diagram of the artificial valve implantation in the first embodiment of the present invention.

[0024] Figure 7 FIG. 12 is an unfolded view of the connection end of the artificial valve in the second embodiment of the present invention cut along a direction parallel to its axial direction.

[0025] Figure 8 FIG. 13 is a distribution diagram of the force application points of the anchoring member after the artificial valve is implanted in the second embodiment.

[0026] Figure 9 FIG. 14 is a schematic structural view of the artificial valve in the third embodiment of the present invention.

[0027] Figure 10 FIG. 15 is a state diagram of the artificial valve implantation in the third embodiment of the present invention.

[0028] Figure 11 FIG. 16 is a schematic structural view of the artificial valve in the third embodiment of the present invention.

[0029] Figure 12Schematic diagram of the artificial valve in the fourth embodiment of the present invention.

[0030] Figure 13 Schematic diagram of the artificial valve in the fifth embodiment of the present invention.

[0031] Figure 14 Schematic diagram of the connection structure and the anchor in the prior art.

[0032] Figure 15 Schematic diagram of the connection structure and the anchor in the prior art when in the compressed state.

[0033] Figure 16 Schematic diagram of the connection structure and the anchor in the fifth embodiment of the present invention.

[0034] Figure 17 Schematic diagram of the connection structure and the anchor in the fifth embodiment of the present invention when in the compressed state. Detailed implementation manners

[0035] To make the above objects, features, and advantages of the present invention more obvious and understandable, the following will describe the detailed implementation manners of the present invention with reference to the accompanying drawings. Many specific details are set forth in the following description in order to fully understand the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific implementations disclosed below.

[0036] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there may also be a middle element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be a middle element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are only for the purpose of illustration and do not represent the only implementation manner.

[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art belonging to the technical field of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific implementation manners and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0038] Regardless of whether it is an implant device or a delivery device for delivering the implant device to the target position, the "proximal end" and "distal end" referred to in the present invention are both referenced with the operator as the benchmark. The end relatively closer to the operator is the proximal end, and the end relatively farther from the operator is the distal end.

[0039] The first embodiment

[0040] Please refer to Figure 1 and Figure 2 , this embodiment provides an artificial valve system 100, including an artificial valve 10 and a delivery device 90 (the delivery device 90 is not shown in Figure 1 and Figure 2 and is shown in Figure 5 ). The artificial valve 10 is delivered into the human body through the delivery device 90 for release, and the artificial valve 10 is detachably connected to the delivery device 10. The artificial valve 10 includes a main body stent 20, a skirt 30, artificial valve leaflets 40, a connecting structure 50 and an anchoring member 60. The main body stent 20 can provide an installation base for the artificial valve leaflets 40, the skirt 30 and the connecting structure 50. The artificial valve leaflets 40, the skirt 30 and the connecting structure 50 are all connected to the main body stent 20, and the anchoring member 60 is arranged on the connecting structure 50.

[0041] Specifically, please refer to Figure 2 , the main body stent 20 includes a plurality of axially connected main body wave rings 21. The main body stent 20 can be made by laser cutting a nickel-titanium tube and then heat setting it, so that when the main body stent 20 is subjected to a radially inward compressive force, the artificial valve 10 can be changed into a shape with a smaller outer contour for easy loading into the delivery device 90. When the radially inward compressive force acting on the main body stent 20 is removed, the main body stent 20 can radially self-expand. Of course, the main body stent 20 can also be made by braiding nickel-titanium wires and then heat setting them.

[0042] The main body stent 20 includes an axially connected first section 22, a second section 23 and a third section 24. The second section 23 is located between the first section 22 and the third section 24. The first section 22 and the third section 24 have parts with a larger outer diameter, and the second section 23 is radially recessed inward relative to the first section 22 and the third section 24. In other words, the second section 23 forms a waist 25 with an outer diameter smaller than the outer diameters of the first section 22 and the third section 24. When the artificial valve 10 is implanted, the parts with a larger outer diameter in the first section 22 and the third section 24 can provide an anchoring force through interference fit with the tissue at the implantation site after self-expansion, while the waist 25 with a smaller outer diameter can maintain a gap with the tissue at the implantation site to avoid blocking the branch blood vessels at the implantation site. For example, when the artificial valve 10 is implanted into the aortic valve 81 (please refer to Figure 6 ), the part with a larger outer diameter in the first section 22 is in interference fit with the valve annulus 82, the connecting end 213 of the third section 24 is in interference fit with the ascending aorta 83, and the waist 25 maintains a gap with the entrance of the coronary sinus 84 to avoid the waist 25 blocking the entrance of the coronary sinus 84, so that blood can flow smoothly into the coronary blood vessels.

[0043] Please refer to again Figure 2, the main body stent 20 has an inflow end 211 and an outflow end 212. After the blood flow enters through the inflow end 211, it then flows out through the outflow end 212. In this embodiment, the free end of the first section 22 is the inflow end 211, and the free end of the third section 24 is the outflow end 212, where the outflow end 212 is connected to the transporter 90 (i.e., the outflow end 212 and the connection end 213 in this embodiment are the same end). In addition, the outflow end 212 is also the proximal end of the main body stent 20. In other words, in this embodiment, the outflow end 212 of the main body stent 20, the connection end 213 of the main body stent 20, and the proximal end of the main body stent 20 are all the same end. Of course, in other embodiments, the inflow end 211 of the main body stent 20 can also be the connection end 213. At this time, the inflow end 211 of the main body stent 20, the connection end 213 of the main body stent 20, and the distal end of the main body stent 20 are the same end.

[0044] Please refer to Figure 1 and Figure 2 , the skirt 30 is disposed within the first section 22 and the second section 23, and the skirt 30 is fixed to the main body stent 20 by sutures. In this embodiment, the skirt 30 wraps the inflow end 211. It should be noted that, in order to show the structure of the main body stent 20, the skirt 30 covering the outer surface of the main body stent 20 is not shown in Figure 1 . The skirt 30 can fix the artificial valve leaf 40 and prevent blood from flowing through the main body stent 20 from areas other than the artificial valve leaf 40. The skirt 30 can be made of a cylindrical cloth having the same shape and size as the inner surface of the self-expanded main body stent 20, and the contour of the end of the skirt 30 near the second section 23 can be trimmed according to the shape of the main body wave ring 21 or the edge of the artificial valve leaf 40, or the contour of the end of the skirt 30 near the second section 23 can directly adopt a flat mouth. The suturing of the skirt 30 is carried out in the natural state after the self-expansion of the main body stent 20 to keep the surface of the skirt 30 tight without affecting the shape of the main body stent 20. The skirt 30 can be made of blood-impermeable materials, such as PET, PTFE, PU, etc., and biotissue materials and tissue engineering materials can also be selected.

[0045] The number of the connection structures 50 in this embodiment is multiple. A plurality of connection structures 50 are all connected to the connection end 213. The plurality of connection structures 50 are circumferentially distributed along the main body stent 20, and a plurality of anchors 60 located in the same plane are evenly distributed. In other embodiments, the minimum number of the connection structures 50 can be one.

[0046] Please refer to Figure 2 and Figure 3, the connection structure 50 in this embodiment includes a connecting member 51 and a mounting member 52 that are connected to each other. The connecting member 51 is elongated. One end of the connecting member 51 is connected to one end of the main body bracket 20, and the other end is connected to the mounting member 52. The connecting member 51 can be connected to the connection end 213 of the main body bracket 20 or to the other end of the main body bracket 20. In this embodiment, the connecting member 51 is connected to the connection end 213 of the main body bracket 20, and all parts of the connection structure 50 are located on the proximal side of the connection end 213 (this proximal side means the side that is closer to the operator when the artificial valve 10 is implanted).

[0047] The width of the mounting member 52 is greater than the width of the connecting member 51, so that the mounting member 52 has a larger mounting position relative to the connecting member 51, facilitating the installation of other components (such as the anchoring member 60) onto the mounting member 52. The connecting member 51 has a smaller width relative to the mounting member 52, is more easily radially compressed, and has less resistance to entering the delivery device 90. It should be noted that in other embodiments, the connection structure 50 may also include only the connecting member 51 or the mounting member 52, as long as the anchoring member 60 can be provided on the connection structure 50 and then on the connection end of the main body bracket 20.

[0048] A receiving structure 53 (the receiving structure 53 can be a hole or a groove) is provided on the outer peripheral surface of the mounting member 52. A part of the anchoring member 60 is received in the receiving structure 53, and the other part of the anchoring member 60 extends outside the receiving structure 53. When the anchoring member 60 is subjected to a radially inward acting force, the anchoring member 60 can elastically deform and be received in the receiving structure 53, and the depth of the receiving structure 53 is greater than or equal to the thickness of the anchoring member 60.

[0049] The number of the anchoring members 60 in this embodiment is multiple. The multiple anchoring members 60 are circumferentially distributed along the main body bracket 20. The axial spacing specifications between the multiple anchoring members 60 and the proximal end (i.e., the connection end) of the main body bracket 20 are of one type, that is, the axial spacing between each anchoring member 60 and the proximal end of the main body bracket 20 is equal, that is, the multiple anchoring members 60 are all located in the same plane, and this plane is perpendicular to the central axis of the main body bracket 20. Preferably in this embodiment, the multiple anchoring members 60 located in this plane are evenly distributed. In other embodiments, the minimum number of the anchoring members 60 is one. It should be noted that the "axial spacing between the anchoring member 60 and the connection end 213" means the axial distance between the end of the anchoring member 60 connected to the main body bracket 20 and the proximal end of the main body bracket 20.

[0050] The anchor 60 is installed corresponding to the connection structure 50 one by one. The anchor 60 can be a structural member with a sharp end or a sharp edge. Specifically, in this embodiment, the anchor 60 is a strip-shaped structural member with a sharp end. The anchor 60 is installed on the mounting member 52 and is located proximal to the connection end 213, and its sharp end faces the direction of blood flow into the body. After the artificial valve 10 is released, the anchor 60 can penetrate into the tissue at the implantation site (such as the blood vessel wall of the ascending aorta 83, the ascending aorta 83 is shown in Figure 6 ), thereby increasing the stability of the artificial valve 10 anchored at the implantation site, and further preventing the artificial valve 10 from shifting after implantation, improving the stability of the artificial valve 10 after being implanted into the body, and further preventing paravalvular leakage. In other embodiments, the anchor 60 can also be directly connected to the connection end 213 of the main body stent 20.

[0051] The anchor 60 is provided on the connection structure 50 such that the anchor 60 can be connected to the connection end 213 of the main body stent 20 through the connection structure 50. Since the connection end 213 is the end of the main body stent 20 connected to the delivery device 90, when the artificial valve 10 is released, the connection end 213 is released after the rest of the main body stent 20 is released. Due to the traction and restraint of the connection end 213 and the restraint of the delivery device 90, the anchor 60 is also released after the rest of the main body stent 20 is released. Thus, during the release process of the artificial valve 10, if it is found that the release position of the artificial valve 10 does not match the expectation after the part of the main body stent 20 other than the connection end 213 is released, the artificial valve 10 can be recovered into the delivery device 90 again, and the release position can be readjusted and then the artificial valve 10 is released again. If the anchor 60 is arranged on the first section 22 and the second section 23, it will cause the anchor 60 to be released together with the main body stent 20 before the connection end 213 is released, and the released anchor 60 penetrates into the tissue, which will further cause the artificial valve 10 to be unable to be recovered into the delivery device 90 again. That is to say, it will cause the artificial valve 10 to be unable to be readjusted and released again. If the implantation position of the artificial valve 10 does not match the expectation, it may cause paravalvular leakage. For example, when the artificial valve 10 is implanted, the whole shifts centripetally into the ventricle, resulting in the skirt 30 being unable to play a sealing role, which will cause paravalvular leakage.

[0052] Specifically, one end of the anchor 60 is fixed to the mounting member 52, such that the anchor 60 can be connected to the connection end 213 through the connection structure 50. The other end of the anchor 60 is a sharp end. The line connecting the two ends in the length direction of the anchor 60 forms an angle a with the axis of the mounting member 52. The range of this angle a is from 10° to 80°. In this embodiment, the range of this angle a is from 30° to 45°, making it easier for the anchor 60 to penetrate into the tissue and preventing the anchor 60 from pushing up the connection end 213 to separate from the tissue wall without penetrating into the tissue, thereby avoiding paravalvular leakage.

[0053] The artificial leaflets 40 are arranged within the main body stent 20. Please refer to Figure 4 , in this embodiment, the number of the artificial leaflets 40 is three. In other embodiments, the number of the artificial leaflets 40 can also be two. The artificial leaflets 40 include a fixed edge 41 and a free edge 42. The fixed edge 41 can be sutured and fixed on the skirt 30 or the main body stent 20. The free edge 42 is not restricted and can open and close at an angle. The free edges 42 of two adjacent artificial leaflets 40 are in contact with each other to achieve the closing of the artificial valve 10 and prevent the blood from flowing back from the outflow end 212 to the inflow end 211; the free edges 42 of two adjacent artificial leaflets 40 are separated, allowing the blood to flow from the inflow end 211 to the outflow end 212, thereby functioning as a one-way valve. In this embodiment, the end of the skirt 30 close to the second section 23 is hermetically connected to the fixed edge 41, which can prevent paravalvular leakage caused by blood penetration at the position of the fixed edge 41.

[0054] The material of the artificial leaflets 40 can be selected from biological tissue materials, such as porcine pericardium, bovine pericardium, equine pericardium, ovine pericardium, porcine heart valve, etc. Of course, polymer materials and tissue engineering materials can also be selected.

[0055] Please refer to Figure 5 , the delivery device 90 includes a sheath 91, a core tube 92 and a fixing seat 93. The fixing seat 93 is fixedly installed outside the core tube 92. A groove 94 for accommodating the connection structure 50 is provided on the surface of the fixing seat 93. The connection structure 50 matches the shape and size of the groove 94. The number of the grooves 94 is the same as the number of the connection structures 50, and the grooves 94 and the connection structures 50 are installed in one-to-one correspondence (the connection structure 50 can be embedded in the groove 94).

[0056] The sheath tube 91 is slidably disposed outside the sheath core tube 92. The sheath tube 91 can reciprocally slide relative to the sheath core tube 92 to retract the fixing seat 93 into the lumen of the sheath tube 91 or expose the fixing seat 93 outside the lumen of the sheath tube 91. When the fixing seat 93 is retracted into the lumen of the sheath tube 91, the inner wall of the sheath tube 91 can limit the position of the connection structure 50 located in the groove 94 to prevent the connection structure 50 from popping out of the groove 94, so that the main body bracket 20 remains connected to the conveyor 90 through the connection structure 50. When the fixing seat 93 is exposed outside the lumen of the sheath tube 91, the inner wall of the sheath tube 91 cancels the limiting effect on the connection structure 50 located in the groove 94, and the connection structure 50 can pop out of the groove 94, so that the main body bracket 20 is disengaged from the conveyor 90 through the connection structure 50.

[0057] Please refer to Figure 6 , in this embodiment, the implantation process is described by implanting the artificial valve 10 into the aortic valve 81. Before implanting the artificial valve 10, first detachably connect the artificial valve 10 to the fixing seat 93 through the connection structure 50 and load the artificial valve 10 into the lumen of the sheath tube 91. Then, the artificial valve 10 loaded in the sheath tube 91 is sequentially passed through the femoral artery, the abdominal aorta (not shown in the figure), the thoracic aorta (not shown in the figure), the aortic arch (not labeled in the figure), and the ascending aorta 82 to reach the aortic valve 81. After reaching the aortic valve 81, the sheath tube 91 is withdrawn, and the artificial valve 10 is gradually released from one end of the main body bracket 20 to the connection end 213. When the end of the sheath tube 91 is withdrawn to the connection end 213, the first section 22, the second section 23, and the third section 24 (except the connection end 213) of the main body bracket 20 have all been released. At this time, the connection end 213 and the anchor 60 have not been released yet. That is to say, at this time, the anchor 60 has not penetrated into the tissue. If it is found that the release position does not match the expectation at this time, the sheath tube 91 can be pushed in the distal direction (i.e., the direction away from the operator, which is also the inflow end 211 in this embodiment), and the artificial valve 10 can be retracted into the sheath tube 91 again. After re-adjusting the position, the artificial valve 10 is released again. When it is confirmed that the release position of the artificial valve 10 is accurate, the connection structure 50 is disengaged from the fixing seat 93, thereby improving the safety of artificial valve implantation, and the anchor 60 can penetrate into the tissue to increase the stability of the artificial valve 10 after implantation.

[0058] When the connection structure 50 is disengaged from the conveyor 90, since there is no other structure connected to the conveyor 90 on the proximal side of the connection structure 50 (that is, the connection structure 50 and the anchor 60 provided on its mounting member 52 are the last parts to be released), that is to say, there is no other structure generating a radially inward external force on the connection structure 50 and the anchor 60, and only the released parts generate a radially outward external force on them, which can increase the driving force for the anchor 60 to penetrate into the tissue. If there is still a part of the structure on the main body stent 20 radially inwardly constrained by the conveyor 90 after the anchor 60 is released, the radially inwardly constrained part will generate a radially inward external force on the anchor 60, which will further reduce the driving force when the anchor 60 penetrates into the tissue. Therefore, it can be known that connecting the anchor 60 to the connection end 213 in this embodiment can increase the probability of the anchor 60 penetrating into the tissue, and can easily penetrate into tissues with greater hardness (such as calcified tissues), avoiding the situation where part of the anchor 60 fails to penetrate into the tissue and tilts the main body stent 20, thereby avoiding paravalvular leakage.

[0059] In addition, since the depth of the accommodating structure 53 is greater than or equal to the thickness of the anchor 60, even if part of the anchor 60 fails to penetrate into the tissue, the anchor 60 can be accommodated in the accommodating structure 53 after being radially compressed, which can ensure that the outer surface of the anchor 60 does not protrude from the outer peripheral surface of the mounting member 52, thereby avoiding the anchor 60 from pushing up the mounting member 52 and the connection end 213, and further avoiding the third section in the main body stent 20 from being pushed up by the connection end 213 to be separated from the tissue wall, so as to avoid generating paravalvular leakage.

[0060] Second Embodiment

[0061] Please refer to Figure 7 , the difference between this embodiment and the first embodiment is that the specifications of the axial spacing between multiple anchors 60 and the proximal end of the main body stent 20 are at least two kinds, and multiple anchors 60 with equal axial spacing from the proximal end of the main body stent 20 are located in the same plane. That is, multiple anchors 60 in this embodiment are distributed on at least two planes. When the anchor 60 penetrates into the tissue, the stress points where the anchor 60 anchors with the tissue are distributed in at least two planes with different axial spacings between the proximal end of the main body stent 20. Compared with the situation where all stress points are only distributed in one plane, it can increase the anti-swaying ability of the artificial valve 10 in the section corresponding to the anchor 60, thereby improving the stability of the artificial valve 10 after implantation, preventing the artificial valve 10 from shifting, and further preventing paravalvular leakage. Preferably, in this embodiment, multiple anchors 60 located in the same plane are evenly distributed.

[0062] Taking the case where the specifications of the axial spacing between multiple anchors 60 and the proximal end of the main body stent 20 are two kinds as an example, please refer to Figure 7 , Figure 7As shown in the unfolded view after cutting the connecting end of the artificial valve 10 along a direction parallel to its axis, it should be noted that the structure of the main body stent 20 in this embodiment is the same as that in the first embodiment. To simplify the drawings, not all structures of the main body stent 20 are shown here. There are two specifications for the axial spacing between multiple anchoring members 60 and the proximal end of the main body stent 20, and the anchoring members 60 with the same specification of the axial spacing from the proximal end of the main body stent 20 are located in the same plane, and the plane is parallel to the radial direction of the main body stent 20.

[0063] Please refer to Figure 7 and Figure 8 specifically, a part of the anchoring members 60 in this embodiment are located in the plane 214 and are distributed circumferentially, and another part of the anchoring members 60 are located in the plane 215 and are distributed circumferentially. In the circumferential direction of the main body stent 20, the axial spacing between any two adjacent anchoring members 60 and the proximal end of the main body stent 20 is different.

[0064] The multiple anchoring members 60 are evenly distributed on two circumferences. After the artificial valve 10 is implanted, the stress points W for the anchoring members 60 to anchor with the tissue are distributed on two planes 214a and 215a. The axial spacing between the planes 214a and 215a and the proximal end of the main body stent 20 is different, thereby increasing the anchoring stability of the artificial valve 10 and avoiding the unstable phenomenon similar to a "see - saw" (the "see - saw" phenomenon refers to the phenomenon that is prone to swing) where the stress points W are only distributed on one plane. Of course, the specification of the axial spacing between the multiple anchoring members 60 and the proximal end of the main body stent 20 can also be three or more. The more specifications of the axial spacing between the multiple anchoring members 60 and the proximal end of the main body stent 20, the higher the stability of the artificial valve 10 after implantation.

[0065] It can be understood that the specification of the axial spacing between the anchoring members 60 and the proximal end of the main body stent 20 can be changed by controlling the length of the connecting structure 50, or the specification of the axial spacing between the installation position of the anchoring members 60 and the proximal end of the main body stent 20 can be controlled. Since the anchoring members 60 are connected to the connecting end 213 through the connecting structure 50 in this embodiment, the specification of the axial spacing between the anchoring members 60 and the proximal end of the main body stent 20 is changed by controlling the length of the connecting structure 50 in this embodiment. In this way, when the specification of the axial spacing between the multiple anchoring members 60 and the proximal end of the main body stent 20 is at least two, the wider mounting members 52 are located on different planes, and the axial spacing between the different planes is greater than the axial length of the mounting member 52. When the artificial valve 10 is radially compressed and deformed, the mounting members 52 will not interfere with each other, which is convenient for sheath insertion.

[0066] The third embodiment

[0067] Please refer toFigure 9 The main body stent 20 has a first side 27 and a second side 28 opposite to the first side 27. When the implanted part of the main body stent 20 has a curved shape, the first side 27 is located on the minor curvature side of the implanted part, and the second side 28 is located on the major curvature side of the implanted part. The number of the anchoring members 60 is plural. In this embodiment, the specifications of the axial spacing between the plural anchoring members 60 and the proximal end of the main body stent 20 are at least three. Among the plural anchoring members 60, the one with the smallest axial spacing from the proximal end of the main body stent 20 is located on the first side 27, and the one with the largest axial spacing from the proximal end of the main body stent 20 is located on the second side 28. Along the circumferential direction of the main body stent 20 from the first side 27 to the second side 28, the axial spacing between the anchoring member 60 and the proximal end of the main body stent 20 gradually increases. It should be noted that "the first side 27 is opposite to the second side 28" means that the first side 27 and the second side 28 are radially opposite.

[0068] Due to individual differences in the human body, when the ascending aorta 83 is short, the ascending aorta 83 has a curved shape. After the artificial valve 10 is implanted, the anchoring member 60 is located in the curved section of the ascending aorta 83. Since the anchoring member 60 is connected to the connection end 213 through the connection structure 50, the inner wall of the ascending aorta 83 will generate a force to bend the connection structure 50, and the connection structure 50 will generate a reaction force to resist bending deformation. When the artificial valve is implanted into a patient with a large bending amplitude of the ascending aorta (that is, the ascending aorta 83 is short), the connection structure 50 has a weak ability to adapt to the shape of the ascending aorta 83, which may cause the connection structure 50 to be unable to fit the wall of the ascending aorta 83 (that is, there is a large gap between the connection structure 50 and the wall of the ascending aorta 83). The connection structure 50 may drive the parts directly or indirectly connected thereto (such as the first section 22 and the third section 24) to separate from the tissue wall of the implanted part. Thus, paravalvular leakage will occur.

[0069] Please refer to Figure 9 and Figure 10, when the artificial valve in this embodiment is implanted into a patient with a large curvature amplitude of the ascending aorta (i.e., the ascending aorta 83 is shorter), since the axial distance between the anchoring member 60 and the proximal end of the main body stent 20 is larger, which is equivalent to the longer length of the connecting structure 50, the resistance generated by the connecting structure 50 will decrease, and the ability of the connecting structure 50 to adapt to the vascular morphology can be increased. Among the multiple anchoring members 60, the one with the largest axial distance from the proximal end of the main body stent 20 is located on the second side 28, and the second side 28 is located on the large curvature side of the implantation site, which can increase the ability of the connecting structure 50 on the large curvature side to adapt to the vascular morphology, avoid the connecting structure 50 driving the part directly or indirectly connected to it to separate from the tissue wall of the implantation site, and thus prevent paravalvular leakage. Among the multiple anchoring members 60, the one with the smallest axial distance from the proximal end of the main body stent 20 is located on the first side 27, and the first side 27 is located on the small curvature side of the implantation site, which can avoid the connecting structure on the small curvature side being too long and causing the connecting structure 50 to be suspended during implantation.

[0070] Specifically, the multiple anchoring members 60 can be distributed in a plane or in an arc surface. When the multiple anchoring members 60 can be distributed in a plane 71, the multiple anchoring members 60 are circumferentially distributed along the main body stent 20 in a plane, and this plane 71 is penetrated by the axis 26 of the main body stent 20. The plane 71 forms an angle θ with the end face where the connecting end 213 is located (i.e., the proximal end face of the main body 20), and the angle θ is an acute angle, which can avoid the straightening force of the connecting structure 50 causing the connecting end 213 and the main body stent 20 to tilt relative to the blood vessel wall, and thus avoid paravalvular leakage. Please refer to Figure 11 , along the circumference of the main body stent 20 from the first side 27 to the second side 28, the multiple ends of the multiple anchoring members 60 connected to the main body stent 20 can also be along the arc track line 73. Along the direction from the first side 27 to the second side 28 along the circumference of the main body stent 20, the slope of the arc track line 73 gradually increases, and the multiple anchoring members 60 form a spatial curved surface shape, which is beneficial to maintaining stability in blood vessels with complex shapes, and can also avoid the straightening force of the connecting structure 50 causing the connecting end 213 and the main body stent to tilt relative to the blood vessel wall, and thus avoid paravalvular leakage.

[0071] Fourth Embodiment

[0072] The difference between this embodiment and the first embodiment is that the connecting structure 50 is connected to one end of the main body stent 20. The connecting structure 50 can be connected to the connecting end 213 of the main body stent 20 or to the other end of the main body stent 20. In this embodiment, preferably, the connecting structure 50 is connected to the connecting end 213 of the main body stent 20.

[0073] Please refer to Figure 12, the connecting member 51 extends in a curve (such as an S-shaped curve, a Z-shaped curve, a W-shaped curve, or other curvilinear curves), so that the connecting member 51 has elasticity. When the connecting member 51 is subjected to a radial force along the main body bracket 20, it can be elastically deformed. The anchoring member 60 is connected to the connecting member 51. When the artificial valve 10 is implanted, the connecting member 51 is compressed by the tissue wall and can be elastically deformed. Even if some of the anchoring members 60 do not penetrate into the tissue, the connecting member 51 will not drive other parts of the main body bracket 20 to separate from the tissue wall, so that the main body bracket 20 is always in contact with the tissue wall, thereby preventing paravalvular leakage. When the artificial valve 10 of this embodiment is implanted in a part with a curved shape (such as the ascending aorta 83), the anchoring member 60 can also adapt to the shape of the blood vessel. In other embodiments, the connecting member can also be made elastic by other means, such as selecting an elastic material, as long as the connecting member 51 has elasticity, which will not be listed one by one here.

[0074] The artificial valve 10 further includes a plurality of waveform segments 86. The waveform segments 86 can be one or several waveforms among W-shaped waves, V-shaped waves, Z-shaped waves, and N-shaped waves. Any two adjacent connecting structures 50 are connected by at least one waveform segment 86, so that a plurality of waveform segments 86 and a plurality of connecting structures 50 are circumferentially connected to jointly form a complete connecting wave ring 87. Through this complete wave ring structure, the radial expansion force of the anchoring member 60 can be increased, the dependence on the driving effect of the anchoring member 60 on the main body bracket 20 when the anchoring member 60 penetrates into the tissue can be reduced, and the reliability of the anchoring member 60 penetrating into the tissue can be increased.

[0075] The wave height of the connecting wave ring 87 is less than or equal to the wave height of the main body wave ring 21, increasing the puncture force of the anchoring member 60.

[0076] Fifth Embodiment

[0077] Please refer to Figure 13 , the difference between this embodiment and the above embodiment is that a plurality of connecting structures 50 are connected to the connecting end 213, and a plurality of connecting structures 50 and the wave ring where the connecting end 213 of the main body bracket 20 is located jointly form a plurality of connecting rings 17. In this embodiment, the wave ring where the connecting end 213 is located is the wave ring at the proximal end of the main body bracket 20. When the artificial valve 10 is connected to the delivery device 90, the connecting ring 17 can be detachably connected to the delivery device 90 through a binding wire (not shown in the figure), and the artificial valve 10 can be quickly installed on the delivery device 90. Therefore, the wave ring where the connecting structure 50 and the connecting end 213 of the main body bracket 20 are located and the connecting structure 50 jointly form a plurality of connecting rings 17, which can facilitate the rapid threading and connection of the artificial valve 10 to the delivery device during installation; when the artificial valve 10 needs to be released, the binding wire can be cut.

[0078] Specifically, in this embodiment, a plurality of connecting structures 50 are connected to the proximal wave loops of the main body stent 20 and form a plurality of closed connecting rings 17. The connecting rings 17 are of a polygonal structure, so that the artificial valve 10 can be connected to the delivery device 90 through a binding wire.

[0079] One end of the connecting structure 50 is connected to the proximal wave loop of the main body stent 20 (i.e., the wave loop where the connecting end 213 is located), and the other end of the connecting structure 50 is a free end. In this embodiment, the connecting structure 50 includes connecting rods 51 connected to each other. The connecting rods 51 connected to each other jointly form a tip 52 at the free end, and the connecting rods 51 are straight. A plurality of connecting structures 50 are annularly connected along the main body stent 20 and form a wave loop member 15, which can increase the radial expansion force of the artificial valve and can increase the reliability of the anchor 60 piercing into the tissue.

[0080] The wave height of the wave loop member 15 is smaller than the wave height of the main body stent 20, which can reduce the overall length of the artificial valve 10, facilitate delivery through the aortic arch, and affect the human tissue as little as possible. Moreover, the smaller the wave height of the wave loop member 15, the greater the driving force for the anchor 60 to pierce into the tissue, and thus the reliability of the anchor 60 piercing into the tissue can be further increased.

[0081] The number of the anchors 60 can be one or more. The anchors 60 can be arranged at any part of the connecting structure 50, such as on the connecting rod 51 or the tip 52. Since the connecting structure 50 is connected to the connecting end 213, during release, the connecting structure 50 is located on the connecting end 213, and the anchors 60 are released after the main body stent 20 is released. If it is found that the release position of the artificial valve 10 does not conform to the expectation, the artificial valve 10 can be recovered again, and after the position is readjusted, it can be released again.

[0082] In this embodiment, the number of the anchors 60 is multiple, and the anchors 60 are arranged on the connecting rods 51. The specifications of the axial spacing between the multiple anchors and the connecting end can be one kind. Of course, the specifications of the axial spacing between the multiple anchors and the connecting end can have multiple specifications as in the previous embodiments, and will not be elaborated here.

[0083] The anchors 60 are arranged on the connecting rods 51 can reduce the outer diameter of the sheath 91, specifically as follows:

[0084] Please refer to Figure 14 and Figure 15, in the prior art (it should be noted here that the so-called prior art herein does not refer to the prior art defined in the Patent Law, and its role is only to facilitate the distinction from the technical solution of this embodiment), when a nickel-titanium tube is laser-cut to obtain a main stent and a connection structure, the width H1 occupied by the two connecting rods 51a is kept unchanged (if the connecting rod 51a is a round rod, the width is the rod diameter), and the anchoring member 60a is arranged on the tip 52a. Since the anchoring member 60a is arranged between the two connecting rods 51a and needs to occupy a certain width, it will reduce the thickness at the tip 52a. During the compression and expansion of the artificial valve, stress concentration is likely to occur at the connection between the anchoring member 60a and the tip 52a. To avoid stress concentration at this position, generally a relatively large R angle is set at the connection between the tip 52a and the anchoring member 60a. And to avoid the thickness at this R angle from being reduced (if the thickness at the R angle is reduced, fracture is likely to occur at this position), it is necessary to increase the width H2 of the tip 52a (that is, the width H2 of the tip 52a needs to be greater than the width H1 occupied by the two connecting rods 51a). When the artificial valve is compressed, adjacent tips 52a are in contact with each other, which will increase the width H1 of the tip 52a and the outer diameter of the sheath tube, making it more difficult for the artificial valve to enter the sheath tube.

[0085] Please refer to Figure 16 and Figure 17 , in this embodiment, the anchoring member 60 can be arranged on the connecting rod 51 by cutting, heat-setting and other treatments on the rod body of the connecting rod 51. Of course, in other embodiments, the anchoring member 60 can also be connected to the connecting rod 51 by other connection methods such as welding. Without changing the width H1 occupied by the two connecting rods 51, there is no need to set a relatively large R angle at the tip 52 and there is no need to increase the width H2 of the tip 52, and it is also possible to avoid fracture at the connection between the anchoring member 60 and the connection structure 50. Compared with the above prior art, arranging the anchoring member 60 on the connecting rod 51 can reduce the width H2 of the tip 52. When the artificial valve is compressed, reducing the width H2 of the tip 52 can reduce the outer diameter of the sheath tube 91 and reduce the difficulty for the artificial valve to enter the sheath tube 91.

[0086] Moreover, the connecting rod 51 is provided with a receiving structure 53 that matches the shape and size of the anchoring member 60. When the artificial valve is compressed, the anchoring member 60 can be received in the receiving structure 53 to avoid increasing the size of the sheath tube 91.

[0087] The technical features of the above embodiments can be combined arbitrarily. For the sake of concise description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification.

[0088] The above embodiments merely represent several implementation manners of the present invention. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all fall within the protection scope of the present invention. Therefore, the protection scope of the present invention patent shall be subject to the appended claims.

Claims

1. An artificial valve, which is delivered by a delivery device. The artificial valve includes a main body stent and a plurality of connection structures. The main body stent includes an inflow end and an outflow end. The inflow end is for blood flow to flow in, and the outflow end is for blood to flow out. The main body stent has a connection end, and the outflow end and the connection end are the same end. The connection structure is connected to the connection end of the main body stent. The artificial valve is detachably connected to the delivery device through the connection structure, and is characterized in that, The artificial valve further includes an anchor, the anchor is disposed on the connection structure, and the anchor is connected to the connection end of the main body stent through the connection structure; the number of the anchors is multiple, the multiple anchors are circumferentially distributed along the main body stent, and the specifications of the axial distances between the multiple anchors and the connection end of the main body stent are at least two kinds.

2. The artificial valve according to claim 1, characterized in that, The connection end of the main body stent and the proximal end of the main body stent are the same end. The main body stent has a first side and a second side opposite to the first side. The specifications of the axial distances between the multiple anchors and the proximal end of the main body stent are at least three kinds. The anchor with the smallest axial distance between the multiple anchors and the proximal end of the main body stent is located on the first side, and the anchor with the largest axial distance between the multiple anchors and the proximal end of the main body stent is located on the second side. Along the circumference of the main body stent from the first side to the second side, the axial distance between the anchor and the proximal end of the main body stent gradually increases.

3. The artificial valve according to claim 2, wherein, Along the circumference of the main body stent from the first side to the second side, the multiple ends of the multiple anchors connected to the main body stent are arranged along an arc-shaped track line.

4. The artificial valve according to claim 3, characterized in that, In the direction from the first side to the second side along the circumference of the main body stent, the slope of the arc-shaped track line gradually increases.

5. The artificial valve according to claim 1 or 2, characterized in that, The multiple ends of the multiple anchors connected to the main body stent are located in a plane and are circumferentially distributed along the main body stent. The plane forms an angle θ with the end face where the connection end is located, and the angle θ is an acute angle.

6. The artificial valve according to claim 1, wherein, The anchor is located on the proximal side of the connection end of the main body stent.

7. An artificial valve system, comprising a delivery device, characterized in that, The artificial valve system further includes the artificial valve according to any one of claims 1 to 6. The artificial valve is releasably connected to the connection end of the main body stent through the delivery device.

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