Artificial heart valve, interventional system, and position registration method for artificial heart valve

Abstract

Disclosed in the present application are an artificial heart valve, an interventional system, and a position registration method for an artificial heart valve. The artificial heart valve comprises: a stent, which is of a cylindrical structure and has a spatially axial direction, the interior of the cylindrical structure being a blood flow channel, and the stent being radially deformable so as to switch between a delivery state in which the stent is radially compressed and a deployed state in which the stent is radially deployed; valve leaflets, which are connected to the stent to control the blood flow channel; and a first radiopaque marker, which is connected to the stent. At the reference angle of viewing of the stent, when the stent rotates around its own axis, the distance between the projection position of the first radiopaque marker and the axis of the stent changes correspondingly.

Description

Prosthetic heart valve, interventional system, and method of position registration of a prosthetic heart valve TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a method of position registration of a prosthetic heart valve, an interventional system, and the prosthetic heart valve. BACKGROUND

[0002] Transcatheter prosthetic heart valve implantation can deliver a prosthetic heart valve to a predetermined site through a catheter assembly via a femoral artery or other path, which has the characteristics of no need for thoracotomy and fast postoperative recovery.

[0003] Taking the aortic valve related parts as an example, two valve sinus parts respectively have right coronary orifice and left coronary orifice, and then respectively communicate with right coronary artery and left coronary artery. When the prosthetic aortic valve is in place, it should ensure that the blood flowing out through the valve leaflet opening enters the coronary artery as much as possible. The commissure between the two adjacent valve leaflets in the human aortic valve should avoid the right and left coronary orifices during the operation. Generally, the middle part of the valve leaflet with the largest opening and closing amplitude in the circumferential direction should be approximately aligned with each coronary orifice. Therefore, how to improve the prosthetic heart valve to facilitate the circumferential registration of the operation process in cooperation with the imaging device has been one of the research directions. SUMMARY

[0004] The present application provides an improved prosthetic heart valve, which can be quickly adjusted in space by the doctor during the operation process through the imaging device in cooperation with the interventional system, and correctly deployed to the predetermined site.

[0005] The present application provides a prosthetic heart valve, comprising:

[0006] a stent, which is a cylindrical structure having an axial direction in space, the inside of the cylindrical structure is a blood flow passage, and the stent can be radially deformed and switched between a radially compressed loading state and a radially expanded deployed state;

[0007] a valve leaflet connected to the stent to control the blood flow passage;

[0008] a first imaging marker connected to the stent, when the prosthetic heart valve rotates around the stent axis under a reference viewing angle, the projection position of the first imaging marker changes the distance from the stent axis accordingly.

[0009] The present application also provides a position registration method of a prosthetic heart valve, which can use the prosthetic heart valve described in the present application. The position registration method comprises:

[0010] Step A100 delivering a prosthetic heart valve to a predetermined position, the prosthetic heart valve comprising a stent and leaflets and a first visualization marker respectively connected to the stent;

[0011] Step A200 adjusting a circumferential attitude of the prosthetic heart valve at the reference view until a projection position of the first visualization marker meets a predetermined;

[0012] Step A300 deploying the prosthetic heart valve.

[0013] Optionally, the position registration method further comprises:

[0014] adjusting a spatial attitude of the prosthetic heart valve at the reference view so that an axis of the prosthetic heart valve tends to be perpendicular to the aortic annulus plane. The adjusting of the spatial attitude of the prosthetic heart valve can be performed in any order or simultaneously with the adjusting of the circumferential attitude of the prosthetic heart valve in step A200, and the reference view used in the adjusting of the spatial attitude of the prosthetic heart valve is independently selected from the first view, or the second view, or switched between the first view and the second view.

[0015] The present application also provides an interventional system having opposite distal and proximal ends, the interventional system comprising:

[0016] a catheter assembly comprising at least two controlled elements, the controlled elements being provided with second visualization markers, the second visualization markers being arranged circumferentially along the controlled elements to indicate a distal direction of the catheter assembly;

[0017] a control handle, the proximal ends of the controlled elements being connected to and controlled by the control handle;

[0018] a prosthetic heart valve, the prosthetic heart valve being provided with a first visualization marker, the distal ends of the controlled elements being cooperatively operated on the prosthetic heart valve, and at the reference view, a projection position of the first visualization marker changes in response to a rotation of the prosthetic heart valve around its axis.

[0019] The present application also provides a position registration method of a prosthetic heart valve, which can be implemented by using the interventional system of the present application, the position registration method comprising:

[0020] Step B100 delivering a prosthetic heart valve loaded on a catheter assembly to a predetermined position, the prosthetic heart valve comprising a stent and leaflets and a first visualization marker respectively connected to the stent, the catheter assembly being provided with second visualization markers;

[0021] Step B200 adjusting a circumferential attitude of the prosthetic heart valve at the reference view until a projection position of the first visualization marker meets a predetermined;

[0022] Step B300, deploying the artificial heart valve.

[0023] The following also provides several optional ways, but not as an additional limitation on the overall scheme described above, just a further supplement or preferred, without technical or logical contradiction, each optional way can be combined alone for the overall scheme described above, but also can be combined between multiple optional ways.

[0024] Optionally, the position registration method further comprises:

[0025] Adjusting the posture of the distal end of the catheter assembly in the reference view, and making the distal end of the catheter assembly approach perpendicular to the aortic valve annulus plane through the indication of the second imaging mark. The adjustment of the posture of the distal end of the catheter assembly and step B200 are performed in any order or synchronously, and the reference view used in the two is independently selected from the first view, or the second view, or switched between the first view and the second view.

[0026] Optionally, the reference view is selected from at least one of the following:

[0027] The first view is consistent with the direction of the line connecting the right coronary ostium and the left coronary ostium;

[0028] The second view is parallel to the aortic valve annulus plane, and along the second view, the line connecting the projection positions of the right coronary ostium and the left coronary ostium is perpendicular to the aortic valve annulus plane.

[0029] Optionally, the determination method of the reference view comprises:

[0030] Collecting heart data and constructing a corresponding heart model;

[0031] Determining the right coronary ostium, the left coronary ostium, and the aortic valve annulus plane according to the heart model;

[0032] Adjusting the view position until the set direction of the reference view is met.

[0033] Optionally, adjusting the posture of the distal end of the catheter assembly comprises:

[0034] Displaying the relative position relationship between the interventional system and the heart model in the reference view;

[0035] Bending the distal end of the catheter assembly to change the orientation, and real-time checking the second imaging mark, which is continuously or intermittently arranged along the circumference of the catheter assembly, until the plane where the second imaging mark is located is parallel to the aortic valve annulus plane.

[0036] Optionally, adjusting the circumferential posture of the artificial heart valve itself comprises:

[0037] rotating the catheter assembly and real-time comparing the projection position of the first radiographic marker with the reference view angle;

[0038] the adjustment is completed (i.e. the projection position is correct) when one of the following conditions is met:

[0039] a) the first radiographic marker is one, and the projection position of the first radiographic marker is at the maximum distance from the axis of the prosthetic heart valve;

[0040] b) the first radiographic marker is two, and the projection positions of the two first radiographic markers are coincident and at the predetermined side of the axis of the prosthetic heart valve;

[0041] c) the first radiographic marker is two, and the line connecting the projection positions of the two first radiographic markers is perpendicular to the aortic annulus plane and at the predetermined side of the axis of the prosthetic heart valve;

[0042] d) the first radiographic marker is three, wherein two of them meet condition b) or condition c), and the other one is at the other side of the axis of the prosthetic heart valve;

[0043] e) the first radiographic marker is three, wherein the projection position of one of them is at the maximum distance from the axis of the prosthetic heart valve, and the projection positions of the other two are coincident and at the axis of the prosthetic heart valve.

[0044] Optionally, the second radiographic marker is configured on the catheter assembly or the prosthetic heart valve.

[0045] Optionally, in the reference view angle, the position where the right coronary ostium and the left coronary ostium are coincident is the first position, and the position where the projection positions of the two first radiographic markers are coincident is the second position, and the adjustment is completed when the first position and the second position are on the same side of the axis of the catheter assembly (i.e. the axis of the stent or the axis of the prosthetic heart valve).

[0046] Optionally, the prosthetic heart valve (i.e. the stent) is configured to be radially deformable and switchable between a radially compressed loading state and a radially expanded deployed state.

[0047] Optionally, the prosthetic heart valve (i.e. the stent) is configured to be radially deformable and switchable between a radially compressed loading state and a radially expanded deployed state.

[0048] In the reference view angle, the projection position of the first radiographic marker is identified based on the loading state.

[0049] Optionally, the valve leaflets include a plurality of pieces that cooperate with each other, and the adjacent two pieces are connected by a commissure, and the first radiographic marker is one and the circumferential position corresponds to one of the commissures.

[0050] Optionally, the leaflets comprise a plurality of pieces that are cooperated with each other, and a commissure is between two adjacent pieces; the first imaging mark is only one, and the circumferential position of the first imaging mark corresponds to one of the commissures.

[0051] Optionally, the leaflets comprise a plurality of pieces that are cooperated with each other, and an edge portion of each leaflet comprises a fixed edge connected to the stent and a free edge cooperated with an adjacent leaflet; the first imaging mark is two, and the circumferential positions of the two first imaging marks are respectively in the middle of the fixed edges of the corresponding leaflets.

[0052] Optionally, the leaflets comprise a plurality of pieces that are cooperated with each other, and a commissure is between two adjacent pieces; an edge portion of each leaflet comprises a fixed edge connected to the stent and a free edge cooperated with an adjacent leaflet;

[0053] The leaflets are respectively a first leaflet, a second leaflet and a third leaflet, and the first imaging mark is three, two of which are respectively in the middle of the fixed edges of the first leaflet and the second leaflet, and the third is corresponding to a commissure adjacent to the third leaflet.

[0054] Optionally, the leaflets are respectively a first leaflet, a second leaflet and a third leaflet, and the first imaging mark is three, two of which are respectively in the middle of the fixed edges of the first leaflet and the second leaflet, and the third is corresponding to a commissure adjacent to the third leaflet.

[0055] Optionally, the leaflets are respectively a first leaflet, a second leaflet and a third leaflet, and the first imaging mark is three, one of which is in the commissure between the first leaflet and the second leaflet, and the other two are respectively on the two sides of the commissure between the first leaflet and the second leaflet in the circumferential direction, and the line connecting the other two in the axial view passes through the axis of the prosthetic heart valve. For example, the line connecting the other two in the axial view passes through the axis of the prosthetic heart valve, and the line is perpendicular to the joint seam of the first leaflet and the second leaflet.

[0056] Optionally, the first imaging mark is two groups, one of which is in the middle of the fixed edge of the corresponding leaflet, and the other is in the commissure, and the axial positions of the two groups are staggered.

[0057] Optionally, in the loaded state, the axial positions of the first imaging mark and the second imaging mark are staggered.

[0058] Optionally, the stent is a grid structure formed by frame strips, and the first imaging mark is inlaid or wrapped in the corresponding frame strip. For example, the first imaging mark is located at the end or the middle region of the stent in the axial direction.

[0059] Optionally, the stent is a grid structure formed by frame strips, two ends of the stent in the axial direction are an inflow side and an outflow side in the normal blood flow direction, and the artificial heart valve further comprises:

[0060] a blocking part continuously distributed along the circumference of the stent and adjacent to the inflow side of the stent, and the first imaging mark is located on the blocking part. The blocking part is a flexible skirt and is made of a biocompatible material, and the skirt is connected to the stent by sewing.

[0061] Optionally, the skirt has a sandwich structure, and the first imaging mark is fixed in the sandwich structure, or the first imaging mark is used as a pre-embedded part in the synthesis process of the skirt.

[0062] Optionally, the controlled part in the catheter assembly comprises:

[0063] a balloon body having a folded state and a fluid-actuated inflated state, and the artificial heart valve is radially compressed and loaded on the outer periphery of the balloon body; and the second imaging mark is arranged on the balloon body and continuously or discontinuously extends along the circumference of the balloon body.

[0064] Optionally, in the reference view, the projection position of the second imaging mark is identified based on the folded state.

[0065] Optionally, the second imaging mark is arranged in a ring-shaped region in space when the balloon body is in the folded state and the inflated state, and the ring-shaped region is arranged around the circumference of the catheter assembly.

[0066] Optionally, the second imaging mark is a ring-shaped part pre-made and then fixed to the balloon body, and the ring-shaped part comprises a flexible base strip and an imaging material coated and fixed to the base strip.

[0067] Optionally, the imaging material is directly coated on the inner wall or the outer wall of the balloon body and then dried to form the second imaging mark.

[0068] Optionally, the controlled part in the catheter assembly comprises:

[0069] a balloon body having a folded state and a fluid-actuated inflated state, and the artificial heart valve is radially compressed and loaded on the outer periphery of the balloon body;

[0070] an inner tube having a guide wire channel inside, the balloon body is arranged on the outer periphery of the inner tube, and the distal end of the balloon body is in sealing cooperation with the outer periphery of the inner tube;

[0071] a guide head fixed to the distal end of the inner tube, the guide wire channel penetrates through the guide head, and the second imaging mark is arranged on the guide head and continuously or discontinuously extends along the circumference of the guide head.

[0072] Optionally, the controlled components in the catheter assembly further comprise:

[0073] a sheath tube located at the outer periphery of the artificial heart valve and axially slidingly fitted relative to the balloon body to allow the artificial heart valve to radially expand, the second visualization marker being arranged on the sheath tube and extending continuously or discontinuously along the circumference of the sheath tube;

[0074] a fluid conduit located at the outer periphery of the inner tube, the proximal end of the balloon body being connected to the fluid conduit, and the radial gap between the fluid conduit and the inner tube serving as a fluid passage connected to the balloon body.

[0075] Optionally, the control handle comprises:

[0076] a support body with a guide groove;

[0077] one or more movable seats sliding along the guide groove, and at least one of the controlled components, such as the proximal end of the sheath tube, being fixed to the corresponding movable seat;

[0078] a driving member mounted on the support body and in transmission cooperation with the corresponding movable seat, and the proximal end of the sheath tube being connected to the movable seat.

[0079] Optionally, another driving member is rotatably mounted on the support body, and the proximal ends of the inner tube and the fluid conduit are both fixed to the driving member.

[0080] In the present application, the visualization marker is arranged to provide a visual effect, improve efficiency and reduce interference with the tubular arterial orifice during the position registration of the artificial heart valve. BRIEF DESCRIPTION OF DRAWINGS

[0081] FIG. 1 is a structural schematic diagram of a heart part;

[0082] FIG. 2 is a structural schematic diagram of the internal structure of an aortic valve part;

[0083] FIG. 3 is a structural schematic diagram of an intervention system of the present application;

[0084] FIG. 4a is a structural schematic diagram of an artificial heart valve in a compressed state (compressed state) in an embodiment of the present application;

[0085] FIG. 4b is a structural schematic diagram of the artificial heart valve in a deployed state in FIG. 4a;

[0086] FIG. 5a is a structural schematic diagram of an artificial heart valve in a compressed state (compressed state) in an embodiment of the present application;

[0087] FIG. 5b is a structural schematic diagram of the artificial heart valve in a deployed state in FIG. 5a;

[0088] Fig. 6 is a flow chart of a method for position registration of a prosthetic heart valve according to an embodiment of the present application;

[0089] Fig. 7 is a schematic view of a first perspective according to an embodiment of the present application;

[0090] Fig. 8 is a schematic view of a position of an annulus and an annulus plane according to an embodiment of the present application;

[0091] Fig. 9 is a schematic view of an annulus and an annulus plane according to an embodiment of the present application;

[0092] Fig. 10 is a schematic view of a prosthetic heart valve according to an embodiment of the present application;

[0093] Fig. 11 is a schematic view of a prosthetic heart valve according to an embodiment of the present application;

[0094] Fig. 12 is a schematic view of a position of a marker according to an embodiment of the present application;

[0095] Fig. 13 is a schematic view of a position of a marker according to an embodiment of the present application;

[0096] Fig. 14 is a schematic view of a position of a marker according to an embodiment of the present application;

[0097] Fig. 15 is a schematic view of a position of a marker according to an embodiment of the present application;

[0098] Fig. 16 is a schematic view of a position of a marker according to an embodiment of the present application;

[0099] Fig. 17 is a schematic view of a prosthetic heart valve according to an embodiment of the present application;

[0100] Fig. 18 is a schematic view of a position of a marker according to an embodiment of the present application;

[0101] Fig. 19 is a schematic view of a position of a marker according to an embodiment of the present application;

[0102] Fig. 20 is a schematic view of a position of a marker according to an embodiment of the present application;

[0103] Fig. 21 is a schematic view of a catheter assembly according to an embodiment of the present application;

[0104] Fig. 22 is a schematic view of a catheter assembly according to an embodiment of the present application;

[0105] Fig. 23 is a schematic view of a catheter assembly according to an embodiment of the present application;

[0106] Fig. 24 is a schematic diagram of the structure of an intervention system according to an embodiment of the present application;

[0107] Fig. 25 is a flowchart of a method of position registration of a prosthetic heart valve according to an embodiment of the present application;

[0108] Fig. 26 is a schematic diagram of a state of a prosthetic heart valve implanted in a predetermined site according to an embodiment of the present application;

[0109] Figs. 27 to 29 are schematic diagrams of the positions of visualization markers before position adjustment of a prosthetic heart valve according to an embodiment of the present application;

[0110] Figs. 30 to 32 are schematic diagrams of the positions of visualization markers after unknown position adjustment of a prosthetic heart valve according to an embodiment of the present application;

[0111] Fig. 33 is a schematic diagram of a state after deployment of a prosthetic heart valve according to an embodiment of the present application;

[0112] Fig. 34 is a schematic diagram of matching of the positions of a prosthetic heart valve after deployment with the positions of ostia of coronary arteries according to an embodiment of the present application;

[0113] Fig. 35 is a schematic diagram of the structure of a prosthetic heart valve according to another embodiment of the present application;

[0114] Fig. 36 is a schematic diagram of the structure of a prosthetic heart valve according to another embodiment of the present application;

[0115] Fig. 37 is a schematic diagram of the structure of a prosthetic heart valve according to another embodiment of the present application;

[0116] Fig. 38 is a schematic diagram of the positions of visualization markers after circumferential position adjustment of the prosthetic heart valve of Fig. 37;

[0117] [Corrected according to Rule 91 01.08.2025] Figs. 39 and 40 are schematic diagrams of changes in the positions of visualization markers during circumferential position adjustment of the prosthetic heart valve of Fig. 37.

[0118] The following signs are used in the figures: 100, aorta; 110, right coronary artery; 111, right coronary orifice (RCO); 120, left coronary artery; 121, left coronary orifice (LCO); 130, aortic valve; 131, native leaflet; 132, native leaflet; 133, native leaflet; 140, sinus; 150, aortic arch; 200, artificial heart valve; 210, stent; 211, inflow side; 212, outflow side; 220, leaflet; 220a, leaflet; 220b, leaflet; 220c, leaflet; 230, first visualization marker; 230a, first visualization marker; 230b, first visualization marker; 230c, first visualization marker; 240, commissure; 240a, commissure; 250, connecting ear; 260, occlusion portion; 300, catheter assembly; 310, balloon body; 311, second visualization marker; 312, guide head; 313, fluid conduit; 314, joint; 315, inner tube; 320, sheath tube; 400, control handle; 410, support body; 420, driving member; 430, movable seat; 440, driving member. DETAILED DESCRIPTION

[0119] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0120] It should be noted that when a component is referred to as being “connected” with another component, it can be directly connected with the other component or there can be a middle component. When a component is referred to as being “disposed on” another component, it can be directly disposed on the other component or there can be a middle component.

[0121] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0122] In the present application, the terms “first”, “second”, etc. are only used for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number or order of the indicated technical features. Therefore, the features defined with “first”, “second” can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of “plurality” is at least two, for example, two, three, etc., unless otherwise specifically limited.

[0123] The following embodiments describe artificial implants, especially artificial heart valves, and catheter assemblies and control handles that form an intervention system with the artificial heart valve. When used to indicate directions, the proximal end in the text generally refers to the side close to the operator (e.g. a doctor), and the distal end refers to the opposite side. Along the intervention path, each component has a relative distal end and proximal end. In theory, when the catheter assembly and the control handle are completely straightened, the straight line between the proximal end and the distal end determines the axial direction, and accordingly determines the radial direction perpendicular to the axial direction and the circumferential direction around the axial direction. When used to refer to a structure, the "end" in the text refers to the end point of the structure or a certain point or area in that direction, or a specific structure connected to the point or area.

[0124] The catheter assembly and the control handle also form a delivery system for delivering and deploying the artificial implant to a predetermined position. The catheter assembly includes a plurality of controlled components, the distal ends of which cooperate to operate the artificial implant, such as delivery, deployment, recovery, adjustment of spatial attitude, etc. Each controlled component can be a hollow tube, a solid rod, a flexible wire, or a combination of various forms. There are multiple controlled components, and at least two of them (using the proximal end as an example) can slide axially or rotate relative to the axial direction. The force applying part (the part directly contacted by the user) for operating each controlled component on the control handle can be directly fixed transmission, or transmission by means of threads, gears and racks, etc.

[0125] The artificial heart valve generally includes a deformable stent and leaflets connected to the stent. The stent is generally cylindrical in shape, with two axial ends being the inflow side and the outflow side in the normal blood flow direction, respectively. The side wall is a hollow grid structure, and the shape or size of the grid structure is not strictly limited unless otherwise stated. The inside of the stent is a blood flow passage, and multiple leaflets cooperate to control the opening and closing degree of the blood flow passage in the stent. In order to position in the body, positioning structures such as anchor spikes, arm parts, etc. that can interact with the surrounding native tissue can be provided on the outer periphery of the stent. In order to prevent leakage, a skirt or anti-leakage material can be provided on the inner side and / or the outer side of the stent as a sealing part.

[0126] The stent is made of a material corresponding to the expansion mode, such as nickel-titanium alloy with shape memory for self-expansion in the body, or stainless steel material for balloon expansion, etc. The stent itself can be formed by cutting a pipe or braiding a wire. The leaflets can be connected to the stent by sewing, bonding or one-piece mold forming.

[0127] For example, the self-expandable stent can be expanded and retracted by a sheath tube wrapped around the outer periphery of the stent. By exposing different parts of the stent to the sheath tube, the expansion and retraction of the stent can be controlled. When the stent is expanded by a balloon, the stent can be expanded and deployed to a predetermined position by inflating the balloon with a fluid after the stent is exposed to the sheath tube. In order to further improve the control, a pull wire can be used, that is, the pull wire passes through the structural gap (or wire hole structure) of the stent. By adjusting the tightness of the pull wire through the control handle, the expansion degree of the stent can be changed, or the connection with the delivery system can be maintained (released). When the pull wire is pulled away from the stent, the stent is allowed to be completely released and separated from the delivery system. The control of the pull wire is also achieved through the controlled components in the catheter assembly.

[0128] The artificial implant is in a radially compressed state, i.e., a loaded state, when it is delivered, and is in an expanded state after being released from the catheter assembly and radially expanded in the body. Unless otherwise specified, the shape of the artificial implant is understood to be in the expanded state, and local deformation caused by the pressure of the surrounding tissue is not considered.

[0129] Due to the complexity of the structure in the body, the catheter assembly often needs to be bent. The corresponding bending member can be in the form of a tube or a wire. The distal end acts on the bent part, and the proximal end operates the bending amplitude or direction through the control handle.

[0130] The artificial heart valve, interventional system, and position registration method of the embodiments of the present application can not only be used for interventional surgery, but also can be used for simulation training of interventional delivery operation outside the human body. The inside of the prosthesis (such as a man-made organ for simulation training or observation) can also be understood as outside the human body.

[0131] Referring to FIGS. 1 and 2, the aorta 100 has an aortic arch 150 near the heart. The aortic arch 150 has three valve sinuses 140 near the left ventricle. The inside of the valve sinus 140 is the aortic valve 130, which specifically includes the native leaflet 131, the native leaflet 132, and the native leaflet 133 that cooperate to control blood flow. One valve sinus has a right coronary orifice (RCO) 111 and further communicates with the right coronary artery 110. Another valve sinus has a left coronary orifice (LCO) 121 and further communicates with the left coronary artery 120. When the artificial heart valve (such as an artificial aortic valve) is implanted, the coronary orifice should be avoided as much as possible to reduce the obstruction of blood flow.

[0132] Referring to FIGS. 3-9, an embodiment of the present application provides an artificial heart valve 200 and an interventional system comprising the artificial heart valve 200. The artificial heart valve 200 comprises:

[0133] The stent 210 is a cylindrical structure, and the side wall can adopt a grid structure surrounded by frame strips. The cylindrical structure has an axial direction in space, and the two ends of the axial direction are the inflow side 211 and the outflow side 212 in the normal blood flow direction. The inside of the cylindrical structure is a blood flow passage. The stent 210 can be radially deformed and switched between a radially compressed loading state and a radially expanded deployed state. The outflow side of the stent 210 can be provided with a connecting ear 250 according to the cooperation mode with the delivery system. The connecting ear 250 can adopt a hole eye or a T-shaped head and the like.

[0134] The leaflets 220 are connected to the stent 210 to control the blood flow passage. In the figure, the leaflets 220 are three pieces that cooperate with each other, and the two adjacent pieces are the commissure 240.

[0135] The first imaging mark 230 is connected to the stent 210. In the figure, the first imaging mark 230 is only one place and the circumferential position corresponds to one of the commissures 240a. The first imaging mark 230 can be inlaid or wrapped into the frame strip at the corresponding position of the stent 210. The axial position of the first imaging mark 230 can be at the end or the middle region of the axial direction of the stent 210. In the figure, the first imaging mark 230 is one unit cell away from the edge of the inflow side 211, and two unit cells away from the edge of the outflow side 212. In order to facilitate the indication of the rotation amplitude of the stent around its own axis, when the prosthetic heart valve 200, i.e. the stent 210, rotates around its own axis, the projection (projection along the reference visual angle direction) position of the first imaging mark 230 changes the distance from the stent axis accordingly. The appropriate number of imaging marks on the prosthetic heart valve 200 can avoid misjudgment caused by interference during imaging, and also reduce additional operations for distinguishing interference.

[0136] Among them, Fig. 4a and Fig. 4b correspond to the prosthetic heart valve 200 of one embodiment, and Fig. 5a and Fig. 5b (the dashed line shows the edge of the leaflet 220) correspond to the prosthetic heart valve 200 of another embodiment. The main difference lies in the slight difference in the structure of the stent 210.

[0137] When the number of the first imaging mark 230 is one, changing the distance from the stent axis is understood as the distance between the first imaging mark 230 itself and the stent axis changes in the interface displayed under the reference visual angle.

[0138] When the number of the first imaging mark 230 is more than one, changing the distance from the stent axis is understood as at least one or all of them change the distance from the stent axis in the interface displayed under the reference visual angle. During the change process, the two can coincide, or the angle of the connecting line can change, and the like.

[0139] In this embodiment, through the setting of the imaging mark, better visualization effect can be provided when the prosthetic heart valve 200 is implanted in the body for position registration, and the interference with the tubular arterial orifice is reduced.

[0140] In the present application, the number of the first visualization mark and the second visualization mark is understood to be able to be configured in a larger number unless specifically limited (such as "only"), but the current mentioned and used can be distinguished under the visualization condition to avoid confusion. The distinguishing manner can be different size, shape, relative position and the like.

[0141] Referring to FIG. 6, based on the improved artificial heart valve in the present application, an embodiment of the present application further provides a position registration method of the artificial heart valve, comprising:

[0142] In step A100, the artificial heart valve is delivered to a predetermined position, the artificial heart valve comprising a stent and leaflets and a first visualization mark connected to the stent, respectively; the artificial heart valve can be preloaded to the catheter assembly 300 and delivered by intervention, and the so-called predetermined position is a position substantially corresponding to the native tissue, for example, the artificial heart valve is substantially located between the native leaflets, so as to be deployed after subsequent adjustment of the posture.

[0143] Under the reference view angle, the current posture of the artificial heart valve can be adjusted to make the axis of the artificial heart valve tend to be perpendicular to the aortic valve annulus plane.

[0144] In the display interface of the imaging device, the first visualization mark observed by the operator is the projection position along the reference view angle. The reference view angle that can be selected in the present application can be selected from at least one of the first view angle and the second view angle, and the view angle can be switched as needed at different stages of implementing the position registration method.

[0145] Referring to FIGS. 7 and 8, wherein the first view angle is consistent with the direction of the line connecting the right coronary orifice and the left coronary orifice, the heart data can be pre-acquired and the corresponding heart model can be constructed (for example, the structural data of the heart of the patient to be operated or the simulated heart for training is acquired by using a scanning device such as CT, and a three-dimensional model is constructed); the positions of the right coronary orifice 111 and the left coronary orifice 121 are obtained in the heart model, the line connecting the right coronary orifice 111 and the left coronary orifice 121 is the reference line L, the first view angle is determined along the direction of the reference line L, i.e., the arrow A in the figure, and the right coronary orifice 111 and the left coronary orifice 121 coincide with each other under the first view angle.

[0146] FIG. 8 simulates the interface observed under the first view angle, and the right coronary orifice 111 and the left coronary orifice 121 can not be at the same height relative to the aortic valve annulus plane M, so under the first view angle, the aortic valve annulus plane M can present a three-dimensional effect, of course, the first view angle can also be parallel to the aortic valve annulus plane M, at this time the aortic valve annulus plane M in the interface is linear.

[0147] Referring to FIG. 9 and FIG. 10, the second view angle needs to meet two conditions. One is that the second view angle is parallel to the aortic valve annulus plane M, and in the spatial angle, the aortic valve annulus plane M is parallel to the plane determined by the three sinus floors of the aorta.

[0148] In operation, the aortic valve annulus plane M can be determined first. In order to facilitate the operation of the operator and real-time observation, the aortic valve annulus plane M is first adjusted to be horizontally arranged in the interface, and then the view angle is adjusted in the aortic valve annulus plane M until the second condition is met, that is, under the second view angle, the line connecting the projection positions of the right coronary orifice 111 and the left coronary orifice 121 is perpendicular to the aortic valve annulus plane M. In some cases, the projection positions of the right coronary orifice 111 and the left coronary orifice 121 can also coincide, which can be regarded as the second view angle.

[0149] The spatial posture is adjusted so that the axis of the artificial heart valve 200 approaches perpendicular to the aortic valve annulus plane, which can be adjusted and confirmed under the second view angle. In the figure, the right coronary orifice 111 is slightly higher as an example. The relative height of the left and right coronary orifices will be different in different cases. For example, in some cases, the projection positions of the right coronary orifice 111 and the left coronary orifice 121 can also coincide under the second view angle. The observation obtained along the reference view angle in each embodiment of the present application can also be understood as the projection in the direction of the reference view angle when not specifically stated.

[0150] In step A100, the axial position of the artificial heart valve 200 relative to the aortic valve annulus plane can also be adjusted to the expected position. For example, in the second view angle in FIG. 9, the height direction of the artificial heart valve 200 in FIG. 9 is adjusted. The determination of the axial position can also use the first imaging mark 230 and / or the second imaging mark 311 to observe the height under the second view angle.

[0151] The expected axial position of the artificial heart valve 200 relative to the aortic valve annulus plane can be determined according to conventional techniques, for example, considering the mutual positioning of the artificial heart valve 200 and the surrounding tissue, and avoiding the orifices of the coronary arteries in the axial position.

[0152] Furthermore, reference marks can also be provided at other positions of the catheter assembly to determine the axial position of the artificial heart valve 200, and the reference marks themselves should be arranged axially offset from the first imaging mark 230 and the second imaging mark to avoid interference with each other. In step A200, the circumferential posture of the artificial heart valve is adjusted under the reference view angle until the projection position of the first imaging mark in the display interface meets the predetermined condition.

[0153] Referring to FIG. 11, in one embodiment, the first visual markers of the prosthetic heart valve 200 are two, the circumferential and axial positions of the first visual marker 230a correspond to the middle of the fixed edge of the valve leaflet 220a, and the circumferential and axial positions of the first visual marker 230b correspond to the middle of the fixed edge of the valve leaflet 220b.

[0154] In FIGS. 12-15, the implementation of step A200 is taken as an example of the first perspective, the right coronary orifice 111 and the left coronary orifice 121 coincide with each other, and the projection positions of both the first visual marker 230a and the first visual marker 230b are on both sides of the axis P of the prosthetic heart valve 200 before registration, i.e., they are not yet in the predetermined position. During adjustment, the prosthetic heart valve 200 can be rotated by controlling the handle, and the projection positions of the first visual marker 230a and the first visual marker 230b change in real time during rotation. When they are on the same side of the axis P and aligned vertically, the spatial connection of the two first visual markers can be approximately parallel to the reference line L, thereby minimizing the interference with the coronary orifice.

[0155] Referring to FIG. 16, the implementation of step A200 can also be performed under the second perspective, under which the right coronary orifice 111 and the left coronary orifice 121 are vertically staggered, and after registration, the first visual marker 230a and the first visual marker 230b approximately coincide at position Q. During the registration process, position Q can be located on one side or the other side of the axis P as the prosthetic heart valve 200 rotates. Only when each coronary orifice is on the same side of the axis P as position Q, i.e., when the prosthetic heart valve 200 is in the correct position, is the adjustment completed.

[0156] Step A300, deploying the prosthetic heart valve 200, can be combined with techniques to complete the radial deformation of the prosthetic heart valve 200 to complete the deployment and attach to the surrounding tissue.

[0157] Referring to FIG. 17, in another embodiment, the valve leaflets in the prosthetic heart valve 200 are valve leaflet 220a, valve leaflet 220b, and valve leaflet 220c, and the first visual markers are three:

[0158] The first visual marker 230a is located in the middle of the fixed edge of the valve leaflet 220a.

[0159] The first visual marker 230b is located in the middle of the fixed edge of the valve leaflet 220b.

[0160] The first visual marker 230c is located in the circumferential position corresponding to the commissure 240, i.e., the spliced part of the first visual marker 230b and the first visual marker 230c.

[0161] The first visualization marker 230a and the first visualization marker 230b are arranged as a group, the first visualization marker 230c is arranged as another group, and the axial positions of the two groups are staggered. The first visualization marker 230c can be arranged at the top of the commissure 240 (the outflow side), and the first visualization marker 230a and the first visualization marker 230b are relatively close to the inflow side as a whole.

[0162] Referring to FIG. 19, when the artificial heart valve 200 is adjusted in the circumferential attitude before deployment, the right coronary orifice 111 and the left coronary orifice 121 coincide with each other in the first view, and the projection positions of the first visualization marker 230a and the first visualization marker 230b are on the same side of the axis P and aligned vertically after registration, and the first visualization marker 230c is on the other side of the axis P.

[0163] Referring to FIG. 20, when the circumferential attitude is adjusted, it can also be performed under the second view, under the second view, the right coronary orifice 111 and the left coronary orifice 121 are staggered vertically and the connecting line is perpendicular to the aortic valve annulus plane M, after registration, the projection positions of the first visualization marker 230a and the first visualization marker 230b coincide at position Q and are on the same side of the axis P, and the projection position of the first visualization marker 230c is on the other side of the axis P.

[0164] The artificial heart valve 200 and the stent 210 are configured to be radially deformable and switchable between a radially compressed loading state and a radially expanded deployed state, and are delivered by the catheter assembly in the loading state. Although the timing of adjusting the attitude of the artificial heart valve 200 is not strictly limited, it is preferable to adjust before the stent 210 is completely radially expanded and deployed, for example, under each reference view, the projection positions of the first visualization markers are identified and compared based on the loading state, and the attitude of the artificial heart valve 200 is adjusted accordingly, which can reduce the frictional resistance of the surrounding tissue when the attitude is adjusted after the stent is radially expanded.

[0165] Another embodiment of the present application also provides an interventional system having opposite distal and proximal ends, the interventional system comprising:

[0166] The catheter assembly 300 comprises at least two controlled elements, such as the balloon body and the sheath tube described below, and the second visualization marker 311 is arranged on the controlled element to indicate the direction of the distal end of the catheter assembly 300;

[0167] The control handle 400 is connected to and controlled by the proximal end of each controlled element.

[0168] The artificial heart valve 200 can adopt the artificial heart valve 200 of other embodiments of the present application, and the distal ends of the controlled members cooperatively operate the artificial heart valve 200. As shown in FIG. 24, in the loaded state, the axial positions of the first imaging marker 230 and the second imaging marker 311 are staggered with each other, reducing mutual interference and ensuring identification effect.

[0169] The controlled members in the catheter assembly 300 can include:

[0170] The balloon body 310 has a folded state and a fluid-acting inflated state, and the artificial heart valve 200 is radially compressed and located at the outer periphery of the balloon body 310 when loaded;

[0171] The inner tube 315 is internally provided with a guide wire channel for conveniently interposing a guide wire, wherein the balloon body 310 is located at the outer periphery of the distal end of the inner tube 315, and the distal end of the balloon body 310 is sealingly matched with the outer periphery of the inner tube 315;

[0172] The guide head 312 is fixed to the distal end of the inner tube 315, and the guide wire channel penetrates through the guide head 312;

[0173] The fluid conduit 313 is located at the outer periphery of the inner tube 315, the proximal end of the balloon body 310 is connected and communicated with the fluid conduit 313, the radial gap between the fluid conduit 313 and the inner tube 315 serves as a fluid channel connected with the balloon body 310, and the proximal ends of the inner tube 315 and the fluid conduit 313 are fixedly connected through the joint 314 provided with interfaces respectively connected with the channels of the inner tube 315 and the fluid conduit 313;

[0174] The sheath tube 320 is located at the outer periphery of the artificial heart valve 200 and is axially slidingly matched with the balloon body 310, and in the delivery state, the sheath tube 320 wraps the artificial heart valve 200 for in-vivo delivery, and in the deployment state, the sheath tube 320 is withdrawn towards the proximal end relative to the balloon body 310, gradually exposing the artificial heart valve 200 to allow the artificial heart valve 200 to radially expand. In this embodiment, the balloon body 310 is inflated to expand the artificial heart valve 200 to be in place.

[0175] The control handle 400 can be correspondingly configured according to the mutual movement modes of the distal controlled members and the artificial heart valve 200, for example, the control handle 400 includes:

[0176] The support body 410 is provided with a guide groove;

[0177] The movable seat 430 is slidingly matched along the guide groove, and the proximal end of the sheath tube 320 is fixed to the movable seat 430;

[0178] The driving member 420 is a rotating sleeve mounted on the support body 410, and the rotating sleeve is internally provided with a screw thread and is in threaded transmission with the movable seat 430 to drive the sheath tube 320 to axially slide through the movable seat 430.

[0179] The driving member 440 is rotatably mounted at the proximal end of the support body 410, and the inner tube 315 and the proximal end of the fluid conduit 313 are fixed to the driving member 440. The balloon body 310 can be driven to rotate by the driving member 440, so as to adjust the circumferential posture of the prosthetic heart valve 200. Of course, the catheter assembly 300 can be driven to move as a whole by the control handle 400.

[0180] In different embodiments, the second imaging mark 311 is arranged on the balloon body 310 and continuously or discontinuously extends along the circumference of the balloon body 310, as shown in FIG. 21. The second imaging mark 311 is arranged on the sheath tube 320 and continuously or discontinuously extends along the circumference of the sheath tube 320, as shown in FIG. 22. The second imaging mark 311 can also be arranged on the guide head 312 and continuously or discontinuously extends along the circumference of the guide head 312, as shown in FIG. 23.

[0181] In the reference visual angle, based on the folding state recognition and the projection position of the second imaging mark 311, if there is a large friction between the balloon body 310 itself or the prosthetic heart valve 200 and the surrounding tissue after the balloon body 310 is inflated, the difficulty of posture adjustment can be increased.

[0182] The first imaging mark 230 and the second imaging mark 311 can both be made of conventional materials and developed under X-ray to indicate the position. Improved processing methods are also provided below. For example, in an embodiment, the second imaging mark 311 can be pre-made into a strip-shaped member or a ring-shaped member. For example, the imaging material can be in powder form and adjusted into a paste or slurry with a certain fluidity, coated to a base strip and dried to obtain the strip-shaped member or the ring-shaped member, which can be fixed to the corresponding controlled member by bonding. In another embodiment, the imaging material in paste or slurry form is directly coated to the controlled member, and then dried to form the second imaging mark 311.

[0183] In order to facilitate the indication of the distal posture of the intervention system at different stages, the second imaging mark 311 is arranged in a ring-shaped region in space at the balloon body 310 in the folding state and the inflated state, and the ring-shaped region is arranged around the circumference of the catheter assembly 300. The ring-shaped region can also be used to determine a reference surface, which is parallel to the axial section of the catheter assembly 300 and can reflect the position and direction of the distal end of the catheter assembly 300.

[0184] In the above embodiments, the arrangement of the imaging marks at different positions can provide better visualization effect and reduce the interference with the tubular arterial orifice when the prosthetic heart valve 200 is implanted in the body for position registration. Based on this, an embodiment of the present application also provides a position registration method of a prosthetic heart valve, as shown in FIG. 25. The position registration method comprises the following steps:

[0185] Step B100, the artificial heart valve 200 loaded in the catheter assembly 300 is delivered to the predetermined position, in this embodiment, the artificial aortic valve is deployed by balloon expansion, the artificial heart valve 200 is radially compressed and loaded in the balloon body 310 and wrapped by the sheath tube 320, and the artificial heart valve 200 enters the body with the balloon body 310. As shown in FIG. 26, the distal end posture of the catheter assembly 300 is adjusted by bending in the reference view (for example, the second view), on the one hand, the artificial heart valve 200 is roughly centered at the aortic valve 130, and on the other hand, the distal end of the catheter assembly 300 is directed to approach perpendicular to the aortic valve annulus plane M by the indication of the second imaging mark 311, the second imaging mark 311 is annularly arranged and can determine the reference plane M', and the shape change of the second imaging mark 311 is observed during adjustment, when it is a horizontal line, that is, the reference plane M' is parallel to the aortic valve annulus plane M, so that when the distal end direction of the catheter assembly 300 meets the expectation, it is basically vertically downward, at this time, the axial position of the artificial heart valve 200 (for details, see the related description of step A100) and the spatial orientation are completed.

[0186] Step B200, in the reference view (for example, the first view), the circumferential posture of the artificial heart valve 200 is adjusted so that the circumferential position between each leaflet 220 and the right and left coronary orifice 111 and 121 corresponds, before adjusting the circumferential posture of the artificial heart valve 200 itself, for example, as shown in FIGS. 27-29, the commissure may interfere with the right and left coronary orifice 111 and 121, if the commissure is placed between the right and left coronary orifice 111 and 121, that is, the circumferential position of the first imaging mark 230 corresponds between the right and left coronary orifice 111 and 121, the interference can be reduced, in order to clearly show the position of the first imaging mark 230, some drawings show the state after the stent is expanded, in actual operation, generally after the circumferential posture adjustment is completed, radial expansion is implemented to complete the deployment.

[0187] Referring to FIGS. 30-32, when adjusting the circumferential posture of the artificial heart valve 200, the balloon body 310 can be rotated by controlling the handle, and the projection position of the first imaging mark 230 is observed during rotation, since the first imaging mark 230 is only one place and the circumferential position corresponds to one commissure, therefore, in the reference view, when the projection position of the first imaging mark 230 is at the maximum distance from the stent axis, that is, the edge of the artificial heart valve 200 in FIG. 18, the adjustment is completed.

[0188] Step B300, referring to FIG. 33, after the adjustment is completed, the balloon body 310 is inflated to expand the artificial heart valve 200 to complete the deployment, as for the withdrawal of the sheath tube 320, it can be performed after the circumferential posture adjustment is completed, or before the distal end posture of the catheter assembly 300 is adjusted, so as to avoid affecting the distal end posture.

[0189] As shown in FIG. 34, as a comparison, the line L1 connecting the middle of the fixed edge of the two leaflets is consistent with the direction of the reference line L, and the maximum opening of the leaflet opening corresponding to each coronary orifice is determined to minimize the influence of the blood flow of the coronary orifice.

[0190] In this application, the selection of the reference view and the specific process of position registration can take into account the ectopia of the coronary orifice of some patients. Relatively speaking, if only the circumferential matching with the commissure of the native leaflet is concerned, the deployed prosthetic heart valve 200 may still interfere with the coronary orifice to some extent.

[0191] As shown in FIGS. 35 and 36, in some embodiments, other arrangements of the first visible marker 230 are also provided, for example, in the prosthetic heart valve, the edge of each leaflet 220 includes a fixed edge connected to the stent 210 and a free edge cooperated with the adjacent leaflet, and the prosthetic heart valve further includes:

[0192] The blocking part 260 is a flexible skirt made of biocompatible material, the skirt is continuously distributed along the circumference of the stent 210 and is adjacent to the inflow side of the stent 210, and the skirt is connected to the stent 210 by sewing. The skirt can have a sandwich structure, and the first visible marker 230 is fixed in the sandwich structure or is embedded as a pre-embedded part during the synthesis of the skirt (understood as also including pre-mixing of the material).

[0193] Since the skirt extends continuously in the circumferential direction, the first visible marker 230 arranged on the skirt is free from the discontinuous position of the stent grid frame, that is, regardless of the shape of the stent grid unit, the first visible marker 230 can be arranged at any position in the circumferential direction, which is more convenient for adjusting the position of the first visible marker 230 before the operation for some cases of ectopia of the coronary orifice.

[0194] The first visible marker in FIG. 36 is two places, the circumferential and axial positions of the first visible marker 230a correspond to the middle of the fixed edge of the leaflet 220a, and the circumferential and axial positions of the first visible marker 230b correspond to the middle of the fixed edge of the leaflet 220b.

[0195] When the first visible marker is only one place, during the circumferential position registration process, especially when there is a small movement close to the correct position, it may be biased for the observer to judge whether it is correctly positioned under the reference view. Adjacent to this position, the distance change caused by the same circumferential rotation angle to the axis P is smaller, which will affect the operation accuracy and the judgment of whether the adjustment is completed. Based on this, as shown in FIGS. 37 to 40, another embodiment of the application provides a prosthetic heart valve 200, the leaflets are respectively the leaflet 220a, the leaflet 220b and the leaflet 220c, and the first visible marker is three places. By comparing with the embodiment shown in FIG. 17, the positions of the three visible markers in this embodiment are rearranged as follows:

[0196] The first imaging mark 230a is located in the commissure between the leaflet 220a and the leaflet 220b and the middle of the fixed rim, and is close to the outflow side in the axial direction;

[0197] The first imaging mark 230b is located in the span range of the leaflet 220b in the circumferential direction, and is close to the inflow-outflow side in the axial direction;

[0198] The first imaging mark 230c is located in the span range of the leaflet 220c in the circumferential direction, and is close to the inflow-outflow side in the axial direction, wherein the line connecting the first imaging mark 230b and the first imaging mark 230c passes through the axis P and is perpendicular to the joint of the leaflet 220a and the leaflet 220b in the axial view.

[0199] After the adjustment of the circumferential posture is completed, the first imaging mark 230b and the first imaging mark 230c are close to each other (the judgment in actual operation is the critical state of overlapping and separating, that is, at least very close) in the reference view (for example, the second view), and are located near the axis P of the prosthetic heart valve 200.

[0200] During the adjustment of the circumferential posture, for example, the first imaging mark 230c is close to the first imaging mark 230b from the right side to the left side until partially overlapping, and then the first imaging mark 230c can be slightly adjusted to the right side until it is in the critical state of overlapping and separating with the first imaging mark 230b. For the observer, the critical state is easier to identify, which can be exactly overlapping or can have a gap E. Compared with identifying the partially overlapping or completely overlapping of the two imaging marks, the critical state is more difficult to identify, has higher sensitivity, is beneficial to the positioning of the first imaging mark 230a, and improves the operation precision.

[0201] The technical features of the above embodiments can be combined in any manner. In order to make the description concise, all possible combinations of the technical features in the above embodiments are not described, but as long as the combinations of the technical features do not exist contradictory, they should be considered as the scope disclosed in the specification. When the technical features in different embodiments are embodied in the same figure, it can be considered that the figure also discloses the combination of each embodiment involved.

[0202] The above embodiments only express several implementation manners of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the patent application scope. It should be noted that for ordinary skilled persons in the art, without departing from the concept of the present application, some modifications and improvements can be made, which are within the protection scope of the present application.

Claims

1. A prosthetic heart valve, characterized in that, The artificial heart valve comprises: a stent, which is a cylindrical structure having an inner blood flow passage and a spatial axial direction, and is capable of radial deformation and switching between a radially compressed loading state and a radially expanded deployed state; a leaflet connected to the stent to control the blood flow passage; a first imaging marker connected to the stent, and when the artificial heart valve rotates around the stent axial line under a reference visual angle, the projection position of the first imaging marker changes the distance from the stent axial line.

2. A method of position registration of a prosthetic heart valve, characterized by, The method comprises: Step A100: delivering an artificial heart valve to a predetermined position, the artificial heart valve comprising a stent and a leaflet and a first imaging marker connected to the stent respectively; Step A200: adjusting the circumferential posture of the artificial heart valve under the reference visual angle until the projection position of the first imaging marker meets a predetermined condition; Step A300: deploying the artificial heart valve.

3. An interventional system having opposite distal and proximal ends, characterized by, The intervention system comprises: a catheter assembly comprising at least two controlled elements, the controlled elements being provided with second imaging markers arranged circumferentially along the controlled elements to indicate the direction of the distal end of the catheter assembly; a control handle, the proximal end of each controlled element being connected to and controlled by the control handle; an artificial heart valve provided with a first imaging marker, the distal end of each controlled element being cooperatively operated on the artificial heart valve, and when the artificial heart valve rotates around its own axial line under a reference visual angle, the projection position of the first imaging marker changes the distance from the artificial heart valve axial line.

4. A method of position registration of a prosthetic heart valve, characterized by, The method comprises: Step B100: delivering an artificial heart valve loaded on a catheter assembly to a predetermined position, the artificial heart valve comprising a stent and a leaflet and a first imaging marker connected to the stent respectively, and the catheter assembly being provided with second imaging markers; Step B200: adjusting the circumferential posture of the artificial heart valve under the reference visual angle until the projection position of the first imaging marker meets a predetermined condition; Step B300: deploying the artificial heart valve.

Images