Artificial valve anchoring device and assembly, and transcatheter heart valve replacement system

Abstract

The present invention relates to an artificial valve anchoring device and assembly, and a transcatheter heart valve replacement system. During transcatheter heart valve replacement, a capture ring and the artificial valve anchoring device are first implanted sequentially. An inflow end of the artificial valve anchoring device is provided with a skirt portion, which can address the problems of perivalvular leakage and regurgitation even before the artificial valve is released. The artificial valve anchoring device is also provided with two connecting arms, which are capable of penetrating gaps at the commissures of native valve leaflets and connecting to the capture ring, without affecting the function or movement of the native valve leaflets. A main body part of the artificial valve anchoring device can cooperate with the capture ring to simplify the patient's complex mitral / tricuspid valve structure into a standardized circular channel, providing a stable anchoring pathway for the artificial valve. The main body part and the artificial valve are connected by means of an interference fit. During subsequent implantation of the artificial valve, the release height of the artificial valve can also be adjusted according to the patient's actual situation.

Description

Prosthetic valve anchoring device, assembly and transcatheter heart valve replacement system TECHNICAL FIELD

[0001] The present application relates to the field of medical devices for heart surgery, in particular to a prosthetic valve anchoring device, assembly and transcatheter heart valve replacement system. BACKGROUND

[0002] Transcatheter valve replacement, also known as percutaneous valve replacement (TAVR), is an interventional treatment method for treating heart valve stenosis or decompensation. Compared with traditional open surgery, transcatheter valve replacement is inserted into the body through a catheter via a blood vessel, without the need for thoracotomy, reducing surgical trauma and recovery time.

[0003] In the implementation of transcatheter valve replacement, the doctor will guide the artificial valve to the patient's heart position using a catheter and position it on the damaged valve. However, research has found that the existing artificial valve has many problems when in use:

[0004] (1) The artificial valve may block the outflow tract of the aorta due to its low placement position;

[0005] (2) In some existing solutions, a "support frame" can be placed at the valve ring first, and then the valve is placed in the middle of the "support frame". During the operation, the "support frame" will completely open the valve leaflet, so that the patient's valve leaflet cannot open and close, and the valve function is completely lost, which may endanger the patient's life due to the inability to implant the artificial valve in time;

[0006] (3) The anatomical structure of the human body's mitral valve or tricuspid valve is complex, and the anatomical structures of different patients differ greatly. The existing artificial valve is difficult to adapt to the use needs of most patients. SUMMARY

[0007] The present application discloses a prosthetic valve anchoring device, assembly and transcatheter heart valve replacement system, which aims to solve the technical problems existing in the prior art.

[0008] The present application adopts the following technical solutions:

[0009] On the one hand, the present application provides a prosthetic valve anchoring device, which comprises a skirt portion, a main body portion and a connecting portion, which are sequentially arranged from the blood inflow end to the blood outflow end;

[0010] The skirt portion is radially outwardly extended, and the small diameter end of the skirt portion is connected with the main body portion;

[0011] The main body part comprises a plurality of polygonal mesh structures connected to each other, and is capable of radial collapse and expansion between a radial collapsed configuration and a radial expanded configuration;

[0012] The connecting part comprises a connecting arm which is folded from the blood outflow end to the blood inflow end and extends radially outwardly and is used for connection or abutment with the fishing ring.

[0013] As a preferred technical solution, the connecting part is provided with two connecting arms which are centrally symmetrically arranged or asymmetrically arranged.

[0014] As a preferred technical solution, the distribution positions of the two connecting arms match the gaps in the junction region of the native leaflet, so that the connecting arms can be inserted into the gaps in the junction region of the native leaflet.

[0015] As a preferred technical solution, the connecting arm has a connecting end and a free end; the connecting end is provided with an arc-shaped chamfer, and the inner diameter of the arc of the arc-shaped chamfer is not less than the cross-sectional diameter of the coil of the fishing ring; and the free end is used for insertion into the coil gap of the fishing ring or abutment at the bottom of the fishing ring.

[0016] As a preferred technical solution, the free end extends outwardly straightly, or the free end is deflected clockwise or counterclockwise from the connecting end and extends outwardly.

[0017] As a preferred technical solution, the included angle between the free end and the main body part is α1, and 30°≤α1≤90°.

[0018] As a preferred technical solution, the middle part of the main body part defines a standard circular channel.

[0019] As a preferred technical solution, the axial length of the main body part is less than the axial length of the native leaflet.

[0020] As a preferred technical solution, the main body part comprises a shape memory material and is capable of self-expansion after being released in the heart.

[0021] As a preferred technical solution, the diameter of the large-diameter end of the skirt part is greater than the diameter of the valve orifice.

[0022] In a second aspect, the embodiments of the present application provide an artificial valve anchoring assembly comprising the artificial valve anchoring device according to any one of the above, and further comprising a fishing ring.

[0023] The fishing ring is in a spiral shape and can be wound outside the chordae tendineae and connected or abutted with the artificial valve anchoring device.

[0024] As a preferred technical solution, the fishing ring is provided with a heart atrium section and a functional section in sequence.

[0025] The heart atrium section can be covered by the skirt part of the artificial valve anchoring device.

[0026] The functional segment includes several turns of coils positioned at the native valve annulus, which are used to cooperate with the main body of the artificial valve anchoring device. The gaps in the coils allow the connecting arms of the artificial valve anchoring device to penetrate and connect with them, or the coils at the bottom of the functional segment abut against the connecting arms of the artificial valve anchoring device.

[0027] In a third aspect, an embodiment of the present invention provides a transcatheter heart valve replacement system, comprising the artificial valve anchoring assembly as described above, and an artificial valve; the artificial valve is interference-fitted with the main body of the artificial valve anchoring device.

[0028] As a preferred technical solution, the artificial valve is configured as a self-expanding valve or a balloon-expandable valve.

[0029] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0030] The present invention provides an artificial valve anchoring device, which can form an artificial valve anchoring assembly together with a fishing ring; when performing transcatheter heart valve replacement, the fishing ring and the artificial valve anchoring device are first implanted in sequence, because the inflow end of the artificial valve anchoring device has a skirt portion, the skirt portion can completely cover and fit tightly against the valve orifice of the mitral valve / tricuspid valve, so that the problems of paravalvular leakage and regurgitation can be solved before the artificial valve is released; the artificial valve anchoring device also has two connecting arms, which can penetrate into the gap in the junction area of ​​the native valve leaflets and connect with the fishing ring, and the axial length of the main body of the artificial valve anchoring device is 1.5mm. It is smaller than the axial length of the native leaflets, so as not to affect the function and movement of the native leaflets; the main body of the artificial valve anchoring device can work together with the capture ring to simplify the patient's complex mitral valve / tricuspid valve structure into a standard circular channel, providing a stable anchoring channel for the subsequent artificial valve. The main body and the artificial valve are connected by interference fit, and because the main body has a certain height, the release height of the artificial valve can be adjusted according to the actual situation of the patient when the artificial valve is subsequently implanted. On the one hand, it can avoid obstruction to the outflow tract to the greatest extent, and on the other hand, it also reduces the difficulty of operating the artificial valve during release.

[0031] Another embodiment of the present application further provides a transcatheter heart valve replacement system, comprising an artificial valve and the artificial valve anchoring assembly, during the heart valve replacement, the snaring ring, the artificial valve anchoring device and the artificial valve are implanted in sequence, compared with the prior art, the snaring ring and the artificial valve anchoring device in the present application are implanted twice, which can effectively reduce the profile value of the delivery device, reduce the delivery difficulty and reduce the damage to the blood vessels of the patient; the artificial valve can be a balloon dilatation valve, compared with a self-expanding valve with a skirt, the delivery system is simpler, the profile value is smaller, the accuracy requirement of the release position is low, and the operation difficulty is lower; compared with a self-expanding valve with a valve leaflet, the difficulty of implanting the artificial valve anchoring device is lower, the length of the artificial valve anchoring device is shorter, the profile value of the delivery system is smaller, and the structure of the delivery system is simpler. BRIEF DESCRIPTION OF DRAWINGS

[0032] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiment description will be briefly introduced as follows, which constitutes a part of the present application. The schematic embodiments of the present application and the description and explanation thereof do not constitute an improper limitation on the present application. In the drawings:

[0033] Fig. 1 is a structural schematic view of a snaring ring in an embodiment disclosed by the present application;

[0034] Fig. 2 is a top view of the snaring ring in an embodiment disclosed by the present application;

[0035] Fig. 3 is a structural schematic view of the artificial valve anchoring device and the snaring ring in a cooperating state in an embodiment disclosed by the present application;

[0036] Fig. 4 is a structural schematic view of the artificial valve anchoring device and the snaring ring in a cooperating state from another angle in an embodiment disclosed by the present application;

[0037] Fig. 5 is a top view of the artificial valve anchoring device and the snaring ring in a cooperating state in an embodiment disclosed by the present application;

[0038] Fig. 6 is a structural schematic view of the artificial valve anchoring device in an embodiment disclosed by the present application;

[0039] Fig. 7 is a top view of the artificial valve anchoring device in an embodiment disclosed by the present application;

[0040] Fig. 8 is a cooperation schematic view of the main body and the artificial valve in an embodiment disclosed by the present application;

[0041] Fig. 9 is a cooperation schematic view of the main body and the artificial valve in another embodiment disclosed by the present application;

[0042] Figure 10 is a schematic view of a capture loop in a prosthetic valve anchoring assembly at the time of implantation in one embodiment disclosed by Example 2 of the present application;

[0043] Figure 11 is a schematic view of a prosthetic valve anchoring device in a prosthetic valve anchoring assembly at the time of implantation in one embodiment disclosed by Example 2 of the present application;

[0044] Figure 12 is a schematic view of a prosthetic valve in a transcatheter heart valve replacement system at the time of implantation in one embodiment disclosed by Example 3 of the present application;

[0045] Figure 13 is a schematic view of a prosthetic valve in one embodiment disclosed by Example 3 of the present application;

[0046] Figure 14 is a schematic view of a transcatheter heart valve replacement system in one embodiment disclosed by Example 3 of the present application;

[0047] Figure 15 is a schematic view of a prosthetic valve in a transcatheter heart valve replacement system at other locations in one embodiment disclosed by Example 3 of the present application;

[0048] Figure 16 is a schematic view of a prosthetic valve in a transcatheter heart valve replacement system at other locations in another embodiment disclosed by Example 3 of the present application.

[0049] BRIEF DESCRIPTION OF DRAWINGS

[0050] Prosthetic valve anchoring device 10, skirt portion 11, main body portion 12, connecting arm 13, connecting end 131, free end 132, capture loop 20, atrial segment 21, functional segment 22, prosthetic valve 30, native valve leaflet 40. DETAILED DESCRIPTION

[0051] In order to make the objectives, technical solutions and advantages of the present application clearer, the technical solutions of the present application will be described below in conjunction with specific embodiments of the present application and corresponding drawings. In the description of the present application, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the context clearly indicates otherwise.

[0052] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connecting" should be understood in a broad sense, for example, can be fixed connection, can also be detachable connection, or integrally connected; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances. In addition, in the description of the present application, the terms "first", "second" and the like are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0053] Obviously, the described embodiments are only part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0054] Embodiment 1

[0055] The artificial valve anchoring device 10 provided by the embodiments of the present application is suitable for being used in the mitral valve or the tricuspid valve, and is preferably used in cooperation with the fishing ring 20 to solve the problems existing in the prior art. Referring to FIGS. 1-9, one end of the artificial valve anchoring device 10 is a blood inflow end corresponding to the atrial side, and the other end is a blood outflow end. The skirt part 11, the main body part 12 and the connecting part are sequentially arranged from the blood inflow end to the blood outflow end.

[0056] Since the artificial valve anchoring device 10 in the present embodiment needs to be released after the fishing ring 20 is implanted, for the convenience of description, the structure of the fishing ring 20 will be partially described in the present embodiment, but those skilled in the art should understand that the artificial valve anchoring device 10 is an independent device, and its structural composition does not include the fishing ring 20 itself.

[0057] As shown in FIGS. 1 and 2, in some embodiments, the fishing ring 20 includes a spiral coil capable of being coiled on the chordae tendineae plexus of the mitral valve / tricuspid valve after being released, and positioning the artificial heart valve stent implanted in the mitral valve / tricuspid valve; in some embodiments, the fishing ring 20 includes an atrial segment 21 and a functional segment 22, wherein the atrial segment 21 is positioned in the atrium and is configured to be curved to generally follow the curvature of the atrial wall, and the functional segment 22 includes a plurality of turns of coils positioned at the native annulus, for supporting the subsequently implanted artificial valve 30.

[0058] As shown in FIG. 3-7, in some embodiments, the skirt portion 11 extends radially outward in the form of a flange, with its small diameter end connected to the main body portion 12; the main body portion 12 is composed of a plurality of interconnected polygonal mesh structures, capable of collapsing radially during delivery and expanding radially after release; the connecting portion is provided with a connecting arm 13, which is folded from the blood outflow end to the blood inflow end and extends radially outward and outward, and the connecting arm 13 can be connected to or abutted against the capture ring 20.

[0059] In some embodiments, the skirt portion 11 includes a plurality of diamond-shaped mesh supports and elastic connecting members, one end of the diamond-shaped mesh support is connected to the main body portion 12 through the elastic connecting member, and the other end can be releasably connected to the corresponding delivery device during delivery; the skirt portion 11 can expand in the form of a flower after release, and the diameter of the skirt portion 11 is preferably larger than the diameter of the valve orifice to ensure complete coverage of the valve orifice, thereby preventing paravalvular leakage; in some embodiments, the diameter of the large diameter end of the skirt portion 11 is larger than the diameter of the atrial segment 21 of the capture ring 20, so that the skirt portion 11 can completely cover the atrial segment 21 of the capture ring 20, to further prevent regurgitation and possible paravalvular leakage at the valve ring; after the connecting arm 13 is connected to or abutted against the capture ring 20, the capture ring 20 will pull the artificial valve anchor device 10 downward in the axial direction, so that the skirt portion 11 further closely adheres to the valve orifice, which can further enhance the effect of preventing paravalvular leakage.

[0060] In some embodiments, the main body portion 12 includes one to several rows of polygonal mesh structures, adjacent mesh structures are connected by wave rods or nodes with a certain elasticity, wherein the polygonal mesh is preferably diamond-shaped, and can also be selected from pentagonal, hexagonal and other units that can form a closed shape.

[0061] In some embodiments, the axial length of the main body portion 12 that is too long or too short can have adverse effects, on the one hand, if the axial length of the main body portion 12 is too long, it will block the outflow tract or interfere with the opening and closing of the valve leaflets, on the other hand, if the axial length of the main body portion 12 is too short, the artificial valve 30 can be deflected relative to the main body portion 12, so that the two are not coaxial, as shown in FIG. 9, resulting in a tight seal, etc. Therefore, the axial length of the main body portion 12 should be less than the axial length of the native valve leaflet, and preferably only one row of polygonal mesh is provided, and the axial length of the main body portion 12 is preferably 3-8 mm, which can ensure that the main body portion 12 does not affect the physiological function of the native valve tissue, and can ensure that the artificial valve 30 is coaxial with the main body portion 12, avoiding the occurrence of unexpected deflection of the artificial valve 30, as shown in FIG. 8.

[0062] In some embodiments, the main body 12 is in a cylindrical structure, the outer side of which is matched with the functional section 22 of the fishing ring 20, and the inner side is matched with the artificial valve 30. A standard circular channel is defined in the middle of the inner side of the main body 12. At this time, no matter what irregular shape the cross section of the native valve annulus of the patient is, it can be adjusted to a standard circle under the joint action of the main body 12 and the functional section 22 of the fishing ring 20, so that the artificial valve 30 can be accurately released in the subsequent operation process, work stably, and ensure that the artificial valve 30 can be fully matched with the shape of the valve annulus, avoiding regurgitation.

[0063] In some embodiments, the inner diameter of the circular channel is greater than the outer diameter of the artificial valve 30, so that the two can be interference fit, ensuring that the artificial valve 30 can be stably connected with the artificial valve anchoring device 10 after release, avoiding displacement of the artificial valve 30 in the cardiac cycle. Further, the release height of the artificial valve 30 relative to the main body 12 can be flexibly adjusted according to the outflow tract of the patient during the operation, so as to maximize the avoidance of the obstruction of the outflow tract, and also reduce the operation difficulty of the artificial valve 30 during release.

[0064] In some embodiments, when the artificial valve anchoring device 10 is suitable for the tricuspid valve, the connecting part is preferably provided with three connecting arms 13; when the artificial valve anchoring device 10 is suitable for the mitral valve, the connecting part is preferably provided with two connecting arms 13. The plurality of connecting arms 13 can be centrally symmetric or asymmetrically distributed. After the artificial valve anchoring device 10 is released, the connecting arms 13 extend radially outward and are connected with the coil gap of the functional section 22 of the fishing ring 20, or the connecting arms 13 extend outward from the bottom of the functional section 22 and abut with it to support the entire fishing ring 20.

[0065] In some embodiments, the artificial valve anchoring device 10 is suitable for the mitral valve, and the connecting part has two connecting arms 13. Since the human mitral valve leaflet is not completely symmetrical, the distribution position of the two connecting arms 13 is preferably matched with the gap of the autologous valve leaflet 40 intersection area, so that the connecting arms 13 can be penetrated out of the gap of the autologous valve leaflet 40 intersection area and connected with the fishing ring 20. At this time, the existence of the connecting arms 13 will not block the opening and closing movement of the autologous valve leaflet 40 of the patient, thereby avoiding the loss of the function of the mitral valve of the patient during the operation, causing a large amount of regurgitation, and endangering life.

[0066] As shown in FIG. 6, in some embodiments, the connecting arm 13 has a connecting end 131 and a free end 132, the connecting end 131 has an arc-shaped chamfer, and the inner diameter of the arc of the arc-shaped chamfer is not less than the cross-sectional diameter of the coil of the capture loop 20, so that when the connecting arm 13 is connected to the capture loop 20, the coil can fall into the arc-shaped chamfer, increasing the stability of the connection between the two; the free end 132 is used to pass through the gap between the coils of the capture loop 20, and the free end 132 is preferably configured in a round blunt structure to prevent damage to the original valve tissue.

[0067] In some embodiments, the angle between the free end 132 and the main body part 12 is a1, and 30°≤a1≤90°, so as to ensure that after the artificial valve anchoring device 10 is released, the connecting arm 13 can smoothly pass through the adjacent coils between the functional section 22 of the capture loop 20, or abut against the bottom coil of the functional section 22, and the part of the connecting arm 13 exposed radially outside the coil can extend obliquely upward, avoiding affecting other surrounding tissue structures in a large area.

[0068] In some embodiments, the free end 132 of the connecting arm 13 is configured to extend obliquely outward in a straight line, at this time, the connecting arm 13 can pass through the gap of the junction area of the patient's native valve leaflet 40 after being released, and further pass through the gap between the adjacent coils, or abut against the bottom coil of the functional section 22; in other embodiments, the free end 132 of the connecting arm 13 is deflected clockwise or counterclockwise from the connecting end 131 and extends obliquely outward, and the deflected structure can further increase the contact area between the connecting arm 13 and the coil, so as to further increase the friction force, ensuring the tightness of the combination of the two.

[0069] In some embodiments, when the connecting arm 13 is used to pass through the gap between the coils of the capture loop 20, the cross-sectional thickness of the connecting arm 13 is not less than the gap between the adjacent coils of the functional section 22 of the capture loop 20, so as to ensure that the connecting arm 13 forms a stable interference connection with the gap between the coils after passing through the gap, increases the friction between the two, and prevents the two from separating; in other embodiments, the cross-sectional thickness of the connecting arm 13 is less than the gap between the adjacent coils of the functional section 22 of the capture loop 20, so that the connecting arm 13 is more easily passed through the gap between the coils.

[0070] In some embodiments, the skirt part 11 and the main body part 12 are connected by welding, sewing, riveting or one-piece forming process, and the connecting part and the main body part 12 are also connected by welding, sewing, riveting or one-piece forming process, and the three are preferably made of the same material, and are in a cylindrical compressed state when transported in the blood vessel, and are opened by self-expansion or balloon expansion after reaching the heart.

[0071] In some embodiments, the artificial valve anchoring device 10 is expanded radially to its released configuration by a balloon, at this time, the device as a whole can be made of medical stainless steel and cobalt-chromium alloy materials.

[0072] In other embodiments, the prosthetic valve anchoring device 10 achieves its radial expansion in its released configuration by self-expansion, in which case the device is made of a shape memory material, preferably a nickel-titanium alloy memory material or other memory polymer material or alloy.

[0073] In the prior art, a similar design scheme is to implant a stent as a "anchoring frame" for fixing the valve during the operation, and then place the prosthetic valve 30 in the "anchoring frame", but in this process, the "anchoring frame" will completely open the patient's native valve leaflet 40, so that it cannot normally open and close, which seriously affects the patient's heart function, and this "anchoring frame" cannot solve the problems of paravalvular leakage and regurgitation, and must rely on the structure (such as the valve skirt) on the prosthetic valve 30 to solve these problems; in addition, the prior art scheme also needs to consider the positional relationship between the prosthetic valve 30 and the "anchoring frame" when releasing the prosthetic valve 30, only when the prosthetic valve 30 is in the appropriate position, the anchoring can be stable, and at the same time, the positional relationship between the prosthetic valve 30 and the patient's annulus also needs to be considered, only when the valve skirt is close to the annulus, can paravalvular leakage and regurgitation be prevented, so the existing scheme has extremely high requirements for the release position of the prosthetic valve 30, and the operation difficulty is extremely great.

[0074] Compared with the prior art, the prosthetic valve anchoring device 10 provided in the embodiment can make the doctor flexibly adjust the release height of the prosthetic valve 30 according to the actual situation of the patient after implantation, and maximize the avoidance of outflow tract obstruction; and the prosthetic valve anchoring device 10 and the capture ring 20 jointly act to simplify the complex mitral valve structure into a circular channel, provide a stable anchoring point for the prosthetic valve 30, and can be applied to most patients; since the prosthetic valve anchoring device 10 has a skirt part 11, the problems of paravalvular leakage and regurgitation can be solved before the prosthetic valve 30 is released, and after the capture ring 20 and the prosthetic valve anchoring device 10 are implanted, the normal function and movement of the patient's valve leaflet will not be affected, thereby reducing the risk of surgery.

[0075] Embodiment 2

[0076] The embodiment of the application provides a prosthetic valve anchoring assembly, which comprises the capture ring 20 and the prosthetic valve anchoring device 10 described in the above embodiment 1, and the technical features already included in the above embodiment 1 are naturally inherited in the embodiment, and will not be described one by one.

[0077] In some embodiments, the snaring ring 20 comprises, from inside to outside, a core and a wrapping layer, the core is made of preformed memory metal, which can elastically deform at least in the radial and axial directions to adapt to the shape change of the myocardial tissue, and the wrapping layer is made of a polymer material to provide friction; further, the snaring ring 20 is also provided with a proximal end connector and a visualization ring, the proximal end connector is used for releasable connection with a delivery device for delivering the snaring ring 20, and the visualization ring is used for observing and determining the position of the snaring ring 20 during the operation.

[0078] Specifically, other structures or specific specifications / shape of the snaring ring 20 can refer to any embodiment disclosed in the prior art, which is not limited in the present embodiment.

[0079] In the present embodiment, taking the mitral valve as an example, the implantation process of the artificial valve 30 anchoring assembly is as follows: first, the snaring ring 20 is implanted by a transcatheter method, as shown in FIG. 10, at this time, since the snaring ring 20 crosses the valve orifice of the patient, it can cause the mitral valve to be incompetent and appear regurgitation; next, the artificial valve anchoring device 10 is implanted by a transcatheter method, as shown in FIG. 11, the connecting arm 13 is first aligned with the gap at the junction of the patient's native leaflet 40, then the artificial valve anchoring device 10 is moved forward and backward, so that the connecting arm 13 can penetrate into and hook the functional segment 22 of the snaring ring 20, then the skirt portion 11 covers the atrial segment 21 of the snaring ring 20, and finally the artificial valve anchoring device 10 is released. At this time, the artificial valve anchoring device 10 is closely attached to the snaring ring 20, and the skirt portion 11 of the occlusion frame covers the valve annulus of the patient, so that abnormal phenomena such as regurgitation or paravalvular leakage do not occur, in addition, since the main body portion 12 of the occlusion frame is relatively low and the connecting arm 13 is located in the gap at the junction of the patient's native leaflet 40, after the snaring ring 20 and the artificial valve anchoring device 10 are implanted, the opening and closing movement of the patient's own mitral valve leaflet is not hindered, so that the patient does not lose the function of the mitral valve during the operation, and a large amount of regurgitation does not occur.

[0080] Embodiment 3

[0081] The present embodiment provides a transcatheter heart valve replacement system, as shown in FIGS. 12-16, which comprises an artificial valve 30 and the artificial valve anchoring assembly described in Embodiment 2 above, and the technical features already included in Embodiments 1 and 2 are naturally inherited in the present embodiment, which will not be repeated here.

[0082] In some embodiments, the artificial valve 30 is released after the implantation of the artificial valve anchoring assembly is completed, and the artificial valve 30 is in interference fit with the main body portion 12 of the artificial valve anchoring device 10.

[0083] As shown in FIG. 13, in some embodiments, the artificial valve 30 is configured as a self-expanding valve or a balloon-expandable valve; when configured as a self-expanding valve, the valve stent of the artificial valve 30 is made of metal or high polymer material, such as nickel-titanium alloy memory material or other memory high polymer material or alloy, and by processing the above-mentioned material, a plurality of polygonal grid structures connected to each other are formed, which can self-expand under the action of body temperature after being released in the heart to restore the original properties; when configured as a balloon-expandable valve, the valve stent of the artificial valve 30 is made of medical stainless steel and cobalt-chromium alloy and the like, and by processing in the form of weaving, welding, rivet connection, threaded connection and the like, a plurality of polygonal grid structures connected to each other are formed, and when released, the expansion of the artificial valve 30 is realized by the expansion force of the balloon, and after the artificial valve 30 is expanded to the required degree, the balloon is withdrawn.

[0084] In the present embodiment, the specific structure and operation mode of the artificial valve 30 can be selected from any of the embodiments disclosed in the prior art, which will not be specifically limited and described herein.

[0085] In the present embodiment, taking the mitral valve and the balloon-expandable valve as an example, the operation process of the transcatheter heart valve replacement system is specifically as follows: first, the fishing ring 20 and the artificial valve anchoring device 10 are released in sequence, and the specific operation process is shown in the above-mentioned embodiment 2, and then the artificial valve 30 is implanted by transcatheter method, and the artificial valve 30 is unfolded inside the artificial valve anchoring device 10, as shown in FIG. 12, since the outer diameter of the artificial valve 30 is larger than the inner diameter of the main body part 12 of the artificial valve anchoring device 10, the two can realize interference fit, so that the artificial valve 30 can be stably anchored inside the artificial valve anchoring device 10, and the release height of the artificial valve 30 can also be adjusted according to the outflow tract condition of the patient, as shown in FIGS. 15 and 16, so as to maximize the avoidance of outflow tract obstruction, at this time, the artificial valve 30 is closely attached to the artificial valve anchoring device 10, and under the action of the skirt part 11, the artificial valve 30 has no paravalvular leakage and regurgitation.

[0086] Compared with the prior art, the fishing ring 20 and the artificial valve anchoring device 10 in the present embodiment are implanted twice, which can effectively reduce the profile value of the delivery device, reduce the delivery difficulty and reduce the damage to the blood vessels of the patient; the artificial valve 30 selects the balloon-expandable valve, compared with the self-expanding valve with skirt, the delivery system is simpler, the profile value is smaller, the accuracy requirement of the release position is lower, and the operation difficulty is lower; compared with the self-expanding valve with valve leaflet, the difficulty of implanting the artificial valve anchoring device 10 is lower, the length of the artificial valve anchoring device 10 is shorter, the profile value of the delivery system is smaller, and the structure of the delivery system is simpler.

[0087] The embodiments of the present application are described above with reference to the accompanying drawings, but the present application is not limited to the above-described specific embodiments, and the above-described specific embodiments are merely illustrative, but not restrictive, and a person of ordinary skill in the art can make many forms under the inspiration of the present application without departing from the purpose of the present application and the scope protected by the claims, and all of them belong to the protection of the present application.

Claims

1. An artificial valve anchoring device, characterized in that: It includes a skirt portion, a main body portion and a connecting portion, which are arranged in sequence from the blood inflow end to the blood outflow end; The skirt portion is radially extended outward, and the small diameter end of the skirt portion is connected to the main body portion; The main body portion includes a plurality of interconnected polygonal mesh structures capable of radially collapsing and expanding between a radially collapsed configuration and a radially expanded configuration; The connecting portion includes a connecting arm, which is folded from the blood outflow end to the blood inflow end and extends radially outwardly. The connecting arm is used to connect with or abut against the fishing ring.

2. The artificial valve anchoring device according to claim 1, characterized in that: The connecting portion is provided with two connecting arms, and the two connecting arms are centrally symmetrically arranged or asymmetrically arranged.

3. The artificial valve anchoring device according to claim 2, characterized in that: The distribution positions of the two connecting arms match the gaps in the junction area of ​​the native valve leaflets, so that the connecting arms can penetrate into the gaps in the junction area of ​​the native valve leaflets.

4. The artificial valve anchoring device according to claim 1, characterized in that: The connecting arm has a connecting end and a free end; the connecting end is provided with an arc chamfer, and the inner diameter of the arc of the arc chamfer is not less than the coil cross-sectional diameter of the fishing ring; the free end is used to penetrate the coil gap of the fishing ring or abut against the bottom of the fishing ring.

5. The artificial valve anchoring device according to claim 4, characterized in that: The free end extends straight outward and obliquely, or the free end deflects clockwise or counterclockwise from the connecting end and extends outward and obliquely.

6. The artificial valve anchoring device according to claim 4, characterized in that: An included angle between the free end and the main body is α1, and 30°≤α1≤90°.

7. The artificial valve anchoring device according to claim 1, characterized in that: A standard circular channel is defined in the middle of the main body.

8. The artificial valve anchoring device according to claim 1, characterized in that: The axial length of the main body is smaller than the axial length of the native valve leaflet.

9. The artificial valve anchoring device according to claim 1, characterized in that: The main body portion includes a shape memory material capable of self-expanding after intracardiac release.

10. The artificial valve anchoring device according to claim 1, characterized in that: The diameter of the large-diameter end of the skirt portion is larger than the diameter of the valve orifice.

11. An artificial valve anchoring assembly, characterized in that: comprising the artificial valve anchoring device according to any one of claims 1 to 10, further comprising a fishing ring; The fishing ring is spiral-shaped and can be coiled outside the chordae tendineae plexus and connected to or abutted against the artificial valve anchoring device.

12. The artificial valve anchoring assembly according to claim 11, characterized in that: The fishing ring is provided with an atrial segment and a functional segment in sequence; The atrial segment can be covered by the skirt portion of the artificial valve anchoring device; The functional segment includes several turns of coils positioned at the native valve annulus, which are used to cooperate with the main body of the artificial valve anchoring device. The gaps in the coils allow the connecting arms of the artificial valve anchoring device to penetrate and connect with them, or the coils located at the bottom of the functional segment abut against the connecting arms of the artificial valve anchoring device.

13. A transcatheter heart valve replacement system, characterized in that: comprising the artificial valve anchoring assembly of claim 12, further comprising an artificial valve; The artificial valve is interference-fitted with the main body of the artificial valve anchoring device.

14. The transcatheter heart valve replacement system according to claim 13, wherein: The prosthetic valve is configured as a self-expanding valve or a balloon-expandable valve.

Images